Modern Pharmaceuticals - February 2011

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Editorial

India beckons…

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he timing seems to be just right! As ‘Modern Pharmaceuticals’ marks the 5th Anniversary with this edition, it is elevating to see the focus on emerging markets, especially India. As the global pharma industry faces an imminent patent cliff – drugs with sales of more than $ 120 billion are slated to go off patent over the next three years – the footprint of generics is bound to get bigger. Added to this is the challenge of declining R&D productivity as far as commercial launch of new innovative drugs are concerned.

Although the emerging markets for pharma currently stand at $ 55 billion (which is small in comparison with the developed markets of Europe or the US), this is forecast to grow sevenfold by 2020. Given this new shift in the global pharma space, the spotlight on India is not surprising.

However, it remains to be seen how prepared we are to leverage the emerging scenario and deliver the goods.

To begin with, the role of supply chain management in the pharma sector is quite complex and critical, where a score of 100 per cent in product availability at an optimal cost as well as customer service is the minimum requirement. Besides, the supply chain processes should be streamlined to meet the health and safety needs of the customer.

So, what are the key drivers for one to excel in pharma supply chain? Well, some of the focus areas include responsiveness, flexibility, visibility, costs and safety, among others. Further, collaboration, planning & forecasting with supply chain partners for right outsourcing along with technology integration and continuous improvements through supply chain metrics hold enough potential to succeed in the dynamic pharma supply chain of today.

This Anniversary Edition – in a new avatar – reflects all these and more! Turn to the exclusive ‘Anniversary Special’ section to discern what some of the captains of the global pharma and logistics industries have to say. Plus, there is much more interesting and useful content inside, with new design elements…Believe, you will benefit from exploring this eclectic mix of latest news, views and analysis as much as we enjoyed putting it together. Have a good read and revert to us with your valuable feedback!

Manas R Bastia Editor manas@infomedia18.in

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Editor: Manas R Bastia

February 2011 I Modern Pharmaceuticals

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Contents Anniversary Special 34 38 42 44 48 50 52 58 60 62 70 72

REGUL A R SEC TIONS Editorial .........................................................15

On a High 5

National News...............................................18

Green Practice

World News...................................................22

Clinical Supplies Management

Events Calendar.............................................94

IT Mantra

Product Update .............................................96

Trace Value

Product Index ..............................................104

Management Mantra

Advertisers’ List...........................................105

Pharma Logistics & Aviation Case Study In Perspective In Dialogue Business Strategy People Matters

88

FE AT URE 26

LEADERS SPEAK 'We are collaborating with foreign pharma and biotech companies to develop better therapies for several diseases' ...says Dr V N Balaji, Director and Chief Scientific Mentor, Jubilant Biosys

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ROUNDTABLE India-China Free Trade Agreement: Measuring the pros and cons

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ANNIVERSARY SPECIAL

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Cold chain logistics in pharma: The next hot business?

75

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INDUSTRY UPDATE Indian pharma industry: Slated to grow global...

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MARKET TRENDS Education in R&D: Scanning the research path

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RETAIL ZONE Creating a sense of employee ownership: For a profitable retail business Rajendra Pratap Gupta International Healthcare Policy & Retail Expert

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CURTAIN RAISER BioAsia 2011: Goes green!

90 Highlights of Next Issue Industry Update Pharma packaging

92 16

Market Trends Equipment/Analytical instrument

Modern Pharmaceuticals I February 2011

National News IDMA signs deal with China’s CPIA The Indian Drugs Manufacturers Association (IDMA) entered into its Golden Jubilee year with the signing of a Memorandum of Understanding (MoU) with the China Pharmaceutical Industry Association (CPIA) at its 49th annual meeting in Mumbai.

The MoU was signed to enhance pharmaceutical trade between the two L-R: N I Gandhi, Chairman Organising countries and help Indian companies Committee; Dr Surinder Singh, DCG(I); gain access to the Chinese market.

Mukul Joshi, IAS Secretary, Dept of Addressing the occasion, Ghulam Pharmaceuticals; Ghulam Nabi Azad; Nabi Azad, Union Minister of Daara B Patel, General Secretary, IDMA; and N R Munjal, President, IDMA Health and Family Welfare, said, “The recent spate of takeovers of Indian pharma companies by MNCs is a matter of serious concern.

This would have repercussions not only on the availability of affordable drugs in India but also across the world.” He recognised that Indian drugs manufacturers must strive to become one of the top global quality manufacturers.

The Indian pharma industry accounts for 8 per cent of the global drugs market. A large number of bulk drugs units is exporting drugs to the US and Europe. India has now attained the highest number of USFDA-approved plants outside the US.

Exco InTouch’s unique SMS and data download to cut costs Exco InTouch has recently announced two unique measures for reducing sponsor costs in clinical trials. The first is the ‘free SMS’ for sponsors who wish to ensure that their text messages reminder services for retention and compliance are provided without the patient incurring any costs. The second feature is new ‘free data download’ – electronic patient reported outcomes using mobile technology [Exco InTouch mobilePRO (ePRO)] solutions – which also eliminates any direct patient costs.

Tim Davis, CEO, Exco InTouch, said, “As the only clinical mobile services provider currently offering this feature, the introduction of ‘free SMS’ and ‘free data download’ reaffirms Exco InTouch’s position as an innovator, leading the way for patient communication solutions.

By removing the patient charging component, sponsors will not only benefit from patient retention and compliance, but also from the associated improvements like shorter study timelines, reduced & controlled budgets and better, more extensive data quality & accuracy.”

Bafna Pharmaceu cals and Orchid Pharma honoured Bafna Pharmaceuticals has recently won the ‘Indian Drug Manufacturers’ Association (IDMA) Quality Excellence Awards for 2010. In addition, the company has been bestowed with another prestigious ‘Udyog Rattan Award’ by the Institute of Economic Studies, New Delhi.

Accepting the award, Bafna Mahaveer Chand, CMD, Bafna Pharmaceuticals, said, “I am extremely honoured to receive the two prestigious awards from such esteemed organisations. It is a big achievement for us as

L-R: Virendra Singh, Secretary General, Insitute of Economic Studies; Korn Dabbaransi, Former Deputy Prime Minister of Thailand; and Bafna Mahaveer Chand

a result of our endless efforts and prolonged dedication to achieve best quality for our

valued customers. Every award we receive motivates us to achieve new heights.”

On another similar occasion, Orchid Pharmaceuticals announced that it has also been conferred with the prestigious ‘Icon of the Year’ award by the Institute of Cost and Works Accountants of India (ICWAI). K Raghavendra Rao, CMD, Orchid Pharmaceuticals, received the award. This award was given during the valedictory function of the 52nd National Convention of ICWAI in Chennai.

Gujarat Government signs MoU with JB SEZ JB SEZ has recently signed a Memorandum of Understanding (MoU) worth ` 1,160 crore with the Government of Gujarat at Vibrant Gujarat 2011. According to the agreement, the sectorspecific Special Economic Zone (SEZ) proposes to invest an estimated ` 160 crore in the development of the SEZ and ` 100 crore through units that will set up their manufacturing facilities in the SEZ. The 312-acre pharma SEZ will create more 18

job opportunities to the tune of 20,000. Commenting on the development, Kayvanna Shah, CEO, JB SEZ Pvt Ltd, said, “The signing of the MoU between JB SEZ and the Government of Gujarat is indeed significant. This indicates that we will have faster and more efficient approvals for pharma companies, allowing them to make faster decisions and kickstart operations immediately. This agreement will further iterate the Gujarat Government’s commitment towards growing and developing the pharma industry in the state.”

The SEZ has also achieved 100 per cent project financial closure.

Modern Pharmaceuticals I February 2011

National News Ranbaxy signs MoU with Government of Yaroslavl Region, Russia Ranbaxy Laboratories Ltd and Government of Yaroslavl Region, Russia, have recently signed a Memorandum of Understanding (MoU) on cooperation in the field of healthcare.

The major areas of cooperation are the development of the healthcare system, new medical technologies in the Yaroslavl Region, including the expansion of educational programmes for medical and pharma communities.

It also includes collaboration in clinical trials and improvement of drug safety

monitoring in medical practice. Ranbaxy will evaluate collaborations with local academic and research centres in the Yaroslavl Region to broaden the scope of medical educational programmes for the professional medical and pharma community. It will supervise the cooperation in clinical trials as well

Quin les opens new unit in Hyderabad to drive early-phase decision making Quintiles has recently opened its new phase I research facility at Hyderabad. Constructed in partnership with Apollo Hospitals Group, the new facility will complement Quintiles’ existing phase I facilities worldwide to help customers navigate complex early development challenges and make key decisions early. It will also give biopharma customers more options to complete integrated phase I programmes across multiple geographies at this pivotal stage in medical research.

Eddie Caffrey, Senior Vice President and Head of Quintiles phase I globally, said, “Sponsors are under intense pressure to speed up delivery of results, ethically and without compromising patient safety or quality of data. With this new state-of-the-art phase I facility in Hyderabad, we will be able to ally with customers by providing access to large number of healthy volunteers for simple studies in parallel to more complex studies conducted by scientific experts in Europe and the US.”

Lincoln Pharma launches India’s first long-ac ng paracetamol Lincoln Pharmaceuticals has recently launched an innovative drug delivery system in paracetamol, Pa12 – India’s first long-acting paracetamol for the treatment of fever and pain. Clinical tests have proven that Pa12 is more effective with longer acting capabilities and fewer side effects. The clinical Mahendra G Patel trials for Pa12 were conducted on more than 500 patients at leading hospitals, which have proven and established the efficacy and tolerability of this product as compared to other brands currently available in the market.

Speaking on the occasion, Mahendra G Patel, Managing Director, Lincoln Pharmaceuticals, said, “Our endeavour to constantly develop new formulations with the goal of providing improved healthcare products for better treatment of consumers has again paid off. The launch of Pa12 with its advanced formulation will provide relief to people suffering from pain and high temperature more effectively. The initial test in the market has been encouraging, and we are sure that the formulation will be well accepted by the industry.”

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as participation in any created clinical trials centre.

The Yaroslavl region is also establishing a pharmaceutical zone and encouraging pharma companies to set up manufacturing facilities and conduct clinical research.

On this development, Arun Sawhney, Managing Director, Ranbaxy, commented, “We are pleased to explore potential opportunities in Yaroslavl to build and strengthen the local pharma industry.”

UK MHRA approves Venus Remedies’ an -cancer drug Venus Remedies Ltd, a leading researchbased Indian pharma company,achieved yet another landmark by receiving the market authorisation for Gemcitabine, one of the key products for the treatment of cancer, via a de-centralised procedure from Medicine and Healthcare Regulatory Agency (MHRA) UK. Some other countries that have achieved this feat are Poland, Germany, Slovenia and Portugal.

Pawan Chaudhary, CMD, Venus Remedies, said, “Venus is all set to capture substantial marketshare by entering the highly lucrative market of Europe, as it stands among the first few to receive market authorisation for Gemcitabine.” The market value of Gemcitabine is $ 1.5 billion worldwide, with more than 30 per cent marketshare from Europe.

Gemcitabine is used in treatment of various types of cancer, including cancer of lungs, pancreas, bladder and breast. Gemcitabine, in combination with Cisplatin, has recently received approval from Food and Drug Administration (FDA) & European Medicines Agency (EMEA) as a first-line treatment for lung cancer, which is one of the most common forms of cancer worldwide and accounts for 1.2 million new cases annually.

With this rare accomplishment, Venus Remedies along with its illustrious product range shall be now entering the European market through its wholly owned subsidiary Venus Pharma GmbH. Modern Pharmaceuticals I February 2011

World News Körber acquires Seidenader Maschinenbau The Hamburg-based Körber Group is buying the company Seidenader Maschinenbau GmbH, Markt Schwaben (near Munich). Seidenader is one of the world’s leading manufacturers of inspection machines, software and vision applications for pharmaceutical production. Körber AG is using this acquisition to boost its fast-growing Pharmaceutical Packaging Systems Division headed by Körber Medipak.

Körber Medipak is the world’s only supplier of comprehensive Gerhard Breu packaging systems for the pharma CEO, Körber Medipak industry, and is a one-stop shop for packaging and automation solutions for different medical dosage forms. Seidenader’s inspection systems for the healthcare industry represent an important and trendsetting addition to the spectrum of services offered by the Körber Medipak Group. “Seidenader dovetails perfectly with Körber Medipak’s companies. Together we will be able to exploit additional growth opportunities,” added Gerhard Breu, CEO, Körber Medipak, and member of the Körber Executive Board.

Microfluidics announces PureNano™ pla orm for MRT applica ons As leading pharma companies explore the benefits of continuous manufacturing and bottom-up nanoparticle creation, Microfluidics has rebranded its innovative Microfluidics Reaction Technology (MRT) for nanoparticle creation as the PureNano™ platform, featuring PureNano Continuous Crystallizer.

PureNano™ combines a unique machine with expert process development to achieve smaller and more consistent particle sizes than previously possible for many applications, especially in pharma and energy industries.

PureNano™ provides research teams with new tools and methods to create stable inhalable formulations, improve bioavailability of antibiotics, target delivery of novel cancer treatments, multi-phase chemical reactions and process intensification.

“PureNano™ is a milestone achievement of innovation for our company and represents a revolutionary and necessary step forward in the evolution of continuous crystallisation,” said Michael C Ferrara, President & CEO, Microfluidics. PureNano/ MRT is a globally patent-pending technology with active filings and applications in Australia, Canada, China, Europe, India, Israel, Japan and the US.

Thermo Fisher Scien fic to launch informa cs innova ons at PITTCON 2011 Thermo Fisher Scientific, Inc, the world leader in serving science, will showcase its new informatics offerings at PITTCON 2011, to be held during March 13-18, at the Georgia World Congress Center, Atlanta. The significant advances in the new Laboratory Information Management System (LIMS) solutions facilitate compliance with industry guidelines such as ISO 17025, and other procedural requirements

such as GMP while delivering time and cost savings to scientists and laboratory managers supporting process industries.

The company will showcase a new feature rich-field solution specifically developed for laboratory professionals working in water and environmental

testing laboratories. It will also exhibit its range of informatics solutions, including LIMS, Chromatography Data Systems (CDS), Electronic Laboratory Notebooks (ELN), Document Management Systems (DMS) and Spectroscopy software.

All of Thermo Fisher’s informatics solutions are designed to ease the burden of regulatory compliance, and the company provides solutions across a broad range of global industries.

Easing processes for profitable manufacturing Malvern Instruments latest INFORM white paper titled ‘The benefits of real-time analysis for process development’ presents the case for investing in real-time process measurement at the pilot studies stage, and is now available for free download from the company’s website http://www.malvern.com/realtime. This new white paper from Malvern examines benefits of real-time analysis for process development.

While much effort is expended in optimising commercially operating plant, getting the process ‘right first time’ can be far more efficient. Real-time 22

analysis of process parameters provides substantial support during developing, streamlining and accelerating the evolution of successful process designs.

Taking on-line particle size analysis as an example, the paper considers the rationale for investing in real-time measurement for pilot-scale work. Case studies are used to illustrate ways in which on-line systems promote efficient process development, easing the transition into profitable manufacturing.

Modern Pharmaceuticals I February 2011

World News Bio-Rad introduces EpiQ™ chroma n analysis kit The new EpiQ™ chromatin analysis kit from Bio-Rad Laboratories, Inc, is a real-time polymerase chain reaction (PCR) assay for rapid quantitative assessment of chromatin structure.

Complementing existing epigenetic assays such as DNA methylation and chromatin immunoprecipitation, the EpiQ kit is the first commercial research tool to help scientists quantify the impact of epigenetic events on gene

expression regulation through changes in the chromatin state.

“The EpiQ chromatin analysis kit provides researchers with an easy and fast way to quantify a gene’s chromatin state. Researchers working on cancer, developmental and stem cell biology can glean direct information of the chromatin state associated with epigenetic marks such as DNA methylation and histone modifications,”

Most downloaded document from Malvern Materials characterisation company Malvern Instruments is known for the breadth and accessibility of the educational offering on its website, from simple news stories to in-depth application notes and interactive presentations. However, by far the most popular document is ‘Basic Principles of Particle Size Analysis’, a paper written by Dr Alan Rawle - Applications Manager - that has been downloaded more than 7,500 times in the past three years.

Beginning with ‘What is a particle?’ and guiding the reader through the fundamentals of measurement, this document taps into Malvern’s long experience and expertise in the field of particle characterisation.

The copy of the document ‘Basic Principles in Particle Size Analysis’ can be downloaded from http://bit.ly/MALBasicPrinciples.

FDA approves topotecan injec on Hospira, Inc, the world leader in generic injectable pharmaceuticals, has recently announced that it has received US Food and Drug Administration (FDA) approval of topotecan injection. This is the first solution formulation of the oncology drug approved in the US. The injection is a generic version of Hycamtin®, which registered sales of more than $ 140 million in the US in 2010. Hospira’s topotecan is indicated for treatment of Small Cell Lung Cancer (SCLC)-sensitive disease after failure of first-line chemotherapy. Thomas Moore, President, Hospira, USA, “Hospira’s version of topotecan expands our portfolio of valueadded generics. We are pleased to offer the medical community access to a lower cost and more convenient version of this key oncolytic.”

The solution formulation of topotecan, with a concentration of 4 mg/4 ml, is designed to improve caregiver convenience and safety.

Hospira expects to launch the product by the end of February.

Hospira’s Specialty Injectable Pharmaceuticals (SIP) offering includes approximately 200 generic injectable drugs in many dosages and formulations. Hospira also has robust pipelines of both generic and biosimilar drugs.

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said Viresh Patel, Marketing Manager for PCR reagents, Bio-Rad. Actively transcribed genes are associated with ‘accessible’ chromatin regions called euchromatin, while transcriptionally silent genes are often in ‘inaccessible’ chromatin regions called heterochromatin. The EpiQ kit can provide quantitative information about chromatin accessibility, which correlates strongly with gene expression.

Allegra for OTC use now sanofi-aventis US, and its US Consumer Healthcare Division, Chattem, Inc, have announced that the US Food and Drug Administration (FDA) has approved the Allegra family of allergy medication products for Over-The-Counter (OTC) use in adults and children.

Allegra-D also relieves nasal congestion and sinus pressure, and will be available without a prescription at the pharmacy counter for use in adults and children aged 12 years and older. From March 2011, Allegra and Allegra-D will be available in their original prescription strengths without a prescription.

“Leveraging our US consumer healthcare platform to convert prescription medicines to OTC products is a key growth driver for sanofi-aventis to become a diversified healthcare company in the US. The approval of Allegra for OTC use further validates our vision to increase our presence in the US consumer healthcare market,” said Hanspeter Spek, President, Global Operations, sanofi-aventis.

The Allegra family of OTC products will be available without a prescription for allergy sufferers in drug, grocery, mass merchandiser and club stores nationwide. This includes Allegra 24-hour and 12-hour tablets for adults and children 12 years of age and older; children’s Allegra 12-hour tablets for six years of age and older, and liquid for use in two years of age and older; children’s Allegra 12-hour orally disintegrating tablets for use in six years of age and older; and Allegra-D 24-hour and 12-hour allergy and congestion extended-release tablets (with a decongestant) for use in children 12 years of age and older.

Modern Pharmaceuticals I February 2011

Leaders Speak

‘We are collabora ng with foreign pharma and biotech companies to develop be er therapies for several diseases’ …says Dr V N Balaji, Director and Chief Scien fic Mentor, Jubilant Biosys. With an exper se of over 20 years in bioinforma cs & drug discovery research and noteworthy achievements, Dr Balaji shares his own experience as well as the latest technologies, challenges and future of the bioinforma cs industry, in terms of job opportuni es – both in domes c and global market.

Meghna Mukherjee How has been your journey in the field of bioinforma cs, chemo-informa cs and scien fic management?

I started my career with Allargen Pharmaceuticals.

Some of our molecular design efforts led to production of a commercially marketed antiacne drug. Later, at Immuno Pharmaceuticals, the use of chemo-informatics and computer modelling efforts led to successful identification of endothelin antagonists, some of which were positioned for anti-hypertensive therapy.

In the last 10 years that I spent at Jubilant, we managed to build up a knowledge base around major targets including bioinformatics and chemo-informatics projects. We are now using this knowledge base for the discovery of new therapies towards cancer, metabolic disorders and Central Nervous System (CNS) diseases by forming collaborations with major pharma companies. This journey at Jubilant has been very satisfactory, scientifically as well as personally.

This would not have been possible without the continued support from our founders and a great team at Jubilant.

What led to the forma on of a drug discovery and research company from a company that focussed only on bioinforma cs? Also, share Jubilant’s focus on Research and Development (R&D) of drugs?

We had started out as a bioinformatics and chemoinformatics company to assimilate knowledge and gradually moved on to drug discovery after establishing the knowledge base. With the 26

Modern Pharmaceuticals I February 2011

Leaders Speak

changes in Intellectual Property Rights (IPR) policies in the country in 2005, we thought of applying this knowledge and continued our efforts towards collaborating drug discovery research with pharma and biotech companies.

At present, we do not have a generic drug development effort of our own. We are collaborating with foreign pharma and biotech companies to develop better therapies for several diseases.

In the last few years, Jubilant Biosys has entered into pacts with many companies like AstraZeneca, Eli Lilly, Orion, etc for drug discovery and development. Which companies (domes c and global) is Jubilant Biosys targe ng to collaborate with in the near future?

We are building collaboration agreements with other pharma and biotech companies along with companies like AstraZeneca, Eli Lilly, Orion, and will soon disclose the names once the agreements are confirmed.

Elaborate on drug discovery in India and major challenges that Jubilant Biosys faces in this aspect.

Some of the major challenges that we face are that there are still some processes involved in procuring reagents to carry on research work. Any delay in procurement of reagents will have a domino effect on the timeline and deliverables, which is critical to faster molecular discovery.

We also need highly experienced professionals in this arena. It is a major challenge to get professionals from abroad, orienting them to local culture and retaining them in the company.

Although we have a good talent pool from our own training centres, but training them is a challenge in itself.

State the impact of bioinforma cs on drug discovery and also share some case studies on how bioinforma cs has helped in the faster and early launch of a product.

February 2011 I Modern Pharmaceuticals

Quick Picks Ideal ďŹ gure Professor V Sasisekaran, who guided me in my early research work.

Best pharma company and why?

There are several outstanding pharma companies like Eli Lilly, Astra Zeneca, Merck, Johnson & Johnson according to the focus of their therapeu c area. The list is quite long, and I am sure many of them will contribute to future drug discovery eorts.

If not in bioinforma cs and drug discovery, where would you have worked?

At teaching and training ins tu ons.

How do you spend your leisure me?

Growing plants and vegetables at home.

The number of new drugs reaching the market has stagnated for a few years now. The impact of bioinformatics on drug discovery is still to come in the near future. New technologies such as the Next Generation Sequencing (NGS), non-coding RNA studies,

Bioinforma cs has a future in iden fying targets, which are yet to be validated and are cri cal to pharma and biotech industry pipeline.

microRNA and RNA interference are the recent technologies that require bioinformatics support. New pathways, new biomarkers and new targets will be the avenues that can impact any drug discovery for better, new and innovative therapies.

Also, bioinformatics has a future in identifying targets, which are yet to be validated and are critical to pharma and biotech industry pipeline.

Biosys has come up with highly specialised databases for the use of chemo-informatics and bioinformatics. One of the databases, namely, ChemBioBase is a collection of more than 2 million small molecular ligands for targets and have all structural and functional properties enumerated.

Likewise, another database named Path Art is a high-end tool with a database having data on 3,600 pathways for disease pathway analysis. There is another specialised database for biomarkers. All these databases are of immense value for pharmaceutical drug discovery, especially target identification and toxicity studies. At Jubilant, we use these technologies for drug discovery projects, including virtual screening of compounds.

Elaborate on the job prospects in the ďŹ eld of bioinforma cs and drug discovery, both domes c and global.

Has Jubilant Biosys developed any advanced technology for data management and integra on?

In the area of bioinformatics, we cannot expect a large number of positions for jobs in the domestic and global market. However, well-trained bioinformaticians with post-doctoral experience have a niche in the areas of their expertise, which they can utilise for drug discovery and particularly biomarkers, pharmacogenomics and systems biology. MPh

Over the past 10 years, Jubilant

(meghna.mukherjee@infomedia18.in)

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Roundtable

India-China Free Trade Agreement

Measuring the pros and cons India’s exper se in formula ons and R&D and China’s bulk manufacturing capability have a racted the a en on of global pharma companies, crea ng a possibility of an FTA between the two na ons. Industry veterans mull over the opportuni es that may arise from this.

Meghna Mukherjee

T

he last decade has seen the rise of regional trading arrangements in various parts of the world. The India-China trade co-operation and open regionalism might foster a development that is outward oriented and intra-regional trade that will be based on comparative advantage and available factors. According to a report by AT Kearney, some of the factors like huge population base in India and China, increasingly strong educational output and low labour costs have placed the two nations clearly as remote service locations. But China is playing to its strengths. It emphasises on niches, which cater to the fast growing East Asian markets, and R&D, which supports its huge manufacturing base. Despite its relatively weaker English skills, China is increasingly selected as a complement to India for global services provision.

Many Indian vendors are establishing centres in China to tap into its complementary skill base and offer their customers a risk-diversified platform.

Several treaties have been made among the Association of Southeast Asian Nations (ASEAN) in the past few years.

The Free Trade Agreements (FTAs) have sometimes proved to be beneficial.

The Indian pharma market will benefit immensely from the FTA between India and China. China is extremely strong in the bulk drugs or the Active Pharmaceutical Ingredients (APIs) sector and India is equally strong in the formulations sector.

This synergy between India and China will pose an excellent opportunity for the Indian pharma industry. Further, India is known for making expert low-cost products, which will benefit both the countries. India has a definitive edge in the formulations

sector globally, and this will help in further lowering of cost duties.

The expectations from this FTA will be its proper implementation so that all industries in both countries can benefit from this agreement. For example, the Indian pharma industry has seen huge benefits with the recent FTA between India and Japan. The reason is that Indian manufacturers will get access to the highly regulated market, while Japanese partners will be able to access the low-cost highquality Indian pharma world.

India is the investment destination for global pharma companies because of the regulatory framework for IPR, economic policies along with the availability of talent pool for sustaining the operations. Several companies source their discovered drugs from Indian companies. China and India (also termed as Chindia) are stimulating revival of the global economy and the GDP is expected to grow by 8-8.5 per cent in the current year. Again, the IPR systems in Chindia also maintain international standards. The generics have observed a market in Chindia. Chindia will propel global pharma market to $ 1.1 trillion by 2014 and the emerging

markets are expected to grow collectively at 13-16 per cent with sales of $ 105-115 billion and export to all regulated markets worldwide. Companies can provide manufacturing solutions at less than 50 per cent of the overseas cost. Chindia also has vast groups of people who will ideally suit for clinical trials, as many of them have not been exposed to modern medicines.

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Bafna Mahaveer Chand Chairman & Managing Director, Bafna Pharmaceuticals

Daara B Patel Secretary General, Indian Drug Manufacturers’ Association (IDMA) Modern Pharmaceuticals I February 2011

Roundtable The FTA between India and China shall agree to lift tariffs, quotas, special fees and taxes as well as other barriers to trade between the entities. Both nations have benefited from the foreign trade and a closer union may sound like an unequal bargain. India’s trade deficit with China has rose over the years and a freer trade might push it wider. But in the longer term, India could be a beneficiary too. China’s cheaply produced goods pose a slight threat to India’s thriving services sector, while in other categories like pharma, India remains significantly ahead. Again, the FTA with China shall increase sales and profits for Indian businesses strengthening the economy, creating job opportunities in the country in the long run. FTA shall also be an opportunity for India to provide financial boost to eradicate poverty, illiteracy, unemployment and corruption. Also inexpensive Chinese power equipment and infrastructure shall help India build

modern factories at a relatively low cost. FTA may result in more jobs losses in India than gains, especially for higher wage jobs; most FTAs have been observed to be bad deals; China has become the world’s factory, cornering 12 per cent share of global manufactured goods production. It is now the most competitive country in the world and way ahead of India, which is at the second place. Also, the subsidy provided to the Chinese manufacturing sector is not known. The domestic exporters in India, may face problems because India currently does not recognise China as a market economy, and China might also attempt to keep both low and high-end manufacturing, given its reluctance to allow currency appreciation.

The negative aspects of the FTA are apprehensions arising from fierce competition and increasing supply of imported products at lesser prices and the demand for domestic goods declining, leaving an adverse impact on the domestic business. In addition, because of lower import tariff, the revenue collection of the government may also be adversely affected.

The scenario for the pharma sector is no different. The most recent example is the FTA between India and Japan. This includes trade and investments, thus increasing the bilateral trade and commerce between the two countries to about $ 11 billion. With this agreement, Indian pharma products will be able to gain access to the highly regulated and the second largest pharma market of the world. Similarly, it is believed that an appropriate bilateral trade between India and China will have the potential to cater to the entire requirements of the generic pharma products of the world, where China will

have an edge in API production and India in pharmaceutical formulations. Current bilateral trade between India and China in the pharma sector is estimated to be $ 3.1 billion. It is a common complaint of the Indian pharma companies that non-tariff barriers in China are hindering their attempts to gain access to the Chinese market. Recent healthcare reforms and removal of various procedural bottlenecks in China would help Indian players to gain increased penetration and access to the fast growing Chinese market with its expanded healthcare delivery system. It is also envisaged that an appropriate FTA between the two countries will be able to catapult the global pharma market to $ 1.1 trillion by 2014.

India and China are the most competitive emerging markets in the world today. The pharma industry, in particular, will have a tremendous impact on the FTA between these two fast developing countries.

China is looking at improving the market access for Indian companies and insisting that the world was big enough for both Asian giants to prosper as partners. However, India should be concerned that it might become a dumping ground for cheap manufactured goods from China. Indo-China FTA seems to be almost in favour of China, considering that it is extremely difficult for Indian companies to penetrate the Chinese market. Further, Indian companies have still not been able to understand the Chinese international trade.

The Chinese laws are not so transparent. There is negligible trade in finished formulations export to China from India.

The Chinese regulatory requirements are also not clear.

However, while India follows an open policy of international trade, the Chinese import policy for finished drugs and methodology for purchase of medicines has never been to India’s advantage. The Chinese are progressing very rapidly in improving their formulations products, while Indian API segment is hardly attempting to compete with China. Considering India’s fast emerging domestic as well as international business in pharmaceutical formulations and drug development related services, the Indian Government has to work out revised policy for substantial support of API production in India, with subsidies and duty drawbacks to encourage India’s capabilities in API production.

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Dhiren Gala Manager – Operations, MAIA Intelligence Pvt Ltd

Tapan J Ray Director General, Organisation of Pharmaceutical Producers of India (OPPI)

T S Jaishankar Chairman, Confederation of Indian Pharmaceutical Industry (CIPI) (SME) Modern Pharmaceuticals I February 2011

Anniversary Special

With Indian pharma expanding across borders, the market for ‘Made in India’ drugs is on a high growth curve. However, this growth is witnessing several barriers when it comes to ‘Logis cs’ or ‘Supply Chain Management (SCM)’in the pharma industry.

Therefore, the pharma logis cs companies should ghten their belts to leverage on such growing business opportuni es. However, Indian pharma logis cs is far behind the Western countries. And, the ques on is: Are the Indian pharma companies and logis cs providers prepared to reap the benefits of this booming industry?

To know the answers read on...

February 2011 I Modern Pharmaceuticals

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On a High 5

Pharma supply chain

Decoding the challenges The pharma industry has tremendous poten al to control supply chain cost in the value chain, as supply chain costs are higher than R&D costs. Hence, companies should map their supply chain processes and op mise the same to ensure product availability at favourable costs. Here are the ďŹ ve key challenges to be factored in during the planning stage.

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ndia’s pharmaceutical industry is now the third largest in the world in terms of volume and 14th in terms of value. According to the data published by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of the Indian pharma industry between September 2008 and September 2009 was $ 21.04 billion. Of this, the domestic market was worth $ 12.26 billion, and showed a strong growth of 21.3 per cent

for the 12 months ending September 2010. It is estimated that over the next 10 years, the domestic market will grow to $ 49 billion, at a Compounded Annual Growth Rate (CAGR) of 15 per cent. By 2015, the increasing population of the higher-income group in the country will open a potential $ 8 billion market for MNCs selling costly drugs. Besides, the domestic pharma market is estimated to touch $ 20 billion by 2015, making India a lucrative destination for clinical trials for global giants.

Pharma supply chain

V Gopalakrishnan Consultant- Logistics and SCM, Confederation of Indian Industries Institute of Logistics

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The pharma supply chain is very complex and highly responsible. This is a highly sensitive supply chain where anything less than 100 per cent customer service level is unacceptable, as it directly impacts the health and safety of people. The solution that most pharma companies adopt is to carry a huge

inventory in the supply chain to ensure close to 100 per cent fill rate. However, it is a herculean task to ensure 100 per cent product availability at an optimal cost unless supply chain processes are streamlined towards customer needs and demands. The pharma supply chain, like in other industries, starts with the sourcing of active and inactive ingredients for approved products.

Dosages are formulated and packed into various configurations. Further, with international marketing focus, packs and pack inserts are made in different languages so as to comply with the regulatory requirements of the respective countries. Products flow through company warehouses, wholesale distributors, retail pharmacies, medical institutions and, finally, reach the end consumer. The flow of information and funds traverses from the customer end to the producer end through various channels.

5 key challenges in pharma supply chain Time & cost factor: A manufacturer who can trim development time by 19 per cent can save up to $ 100 million. A drug that reaches the market late could cost companies about $ 1 million a day.

Hence, the time to market is extremely critical for pharma companies for introducing a drug as soon as possible.

This is why logistics cost is 45-50 per cent among other costs in the pharmaceutical value chain.

Counterfeit issues: The threat of counterfeit drugs entering the market is greater than ever before and so is the Modern Pharmaceuticals I February 2011

On a High 5 risk of pilferage. The challenges lie in tackling the counterfeit pharma and APIs being exported. The number of cases of counterfeiting reported by the Food and Drug Administration (FDA) has risen over the last few years. It clearly emphasises the complexity of supply chain design for today’s environment.

Hence, the supply chain managers should rethink their strategy and process on distribution, warehousing, transportation and outsourcing activities to prevent counterfeit in their supply chain. The new technologies such as Radio Frequency Identification (RFID) would help to track and trace products and prevent any counterfeit activities into the products from the design stage to consumer stage.

Outsourcing: Outsourcing is the key strategy to reduce the time to market and increase flexibility. Today, the pharma industry is moving towards planning for a range of capabilities instead of specific product requirements. An outsourcing partner that can reduce product development cycles, eliminate bottlenecks and provide immediate access to advanced technologies and expertise would be a valuable asset. Such a flexibility would also ensure the responsiveness by responding to customer requests for special packaging or labelling, quickly adopting new production technologies or getting new products on the market as soon as they receive approval. The time required to establish a new capacity is significant, ie, 3-4 years for bulk production and 2-3 years for formulation. The speed, flexibility, visibility, responsiveness, costs and safety are the key drivers for the excellence in pharma supply chain. The collaborating, planning and forecasting with supply chain partners (contract manufactures, third party logistics service providers), outsourcing, earlier involvement of vendor in product designing, technology integration as well as continuous improvements through supply chain metrics are the key strategies for the pharma supply chain to ensure product availability at optimal costs in today’s environment. Hence, companies should use outsourcing as a key strategy for competitive advantage rather than reducing their burden on non-core activities and also leverage the clinical research outsourcing potential to gain the competitive advantage by reducing product development time.

Technology integration, visibility: Although the security of data appears to be sacrosanct, companies should share necessary data with at least key vendors and customers in order to avoid any lost sales, missed deliveries, obsolete inventory and poorly planned promotions. Sharing the information with vendors and involving them early into product designing would reduce the development process time. Although forecasting accuracy has been shown to improve from 30 per cent to 65 per cent over a 12-week forecast in the pharma industry, there is considerable scope to improve it further. For instance, a recent research suggested that the first seven weeks of new product demand data is enough to establish a trend for planning if companies integrate their vendors and customers along the supply chain by sharing the information at the right time by implementing tools like Collaborating Planning, Forecasting and Replenishment (CPFR) and vendor managed inventory. Hence, pharma February 2011 I Modern Pharmaceuticals

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On a High 5 Figure 1: Pharmaceutical supply chain

players should rethink their strategy on information sharing in order to sense the real demand in the market.

Metrics, continuous improvements: To ensure continuous improvements in the supply chain processes, pharma companies need to put in place clear performance measures.

What can be measured is what is noticed and can be improved continuously.

The best approach is to assemble a performance scorecard of metrics that are key to the business, and the metrics should be objective, quantifiable and balanced.

The Supply Chain Operations References (SCOR) model and Balanced Score Card are some of the noted performance measurement models. Responsiveness, flexibility, inventory turnover, cash to cash cycle and asset turnover are some of the key performance indicators in the supply chain.

Survey report on performance measures in pharma supply chain Pipeline stocks may be 30-110 per cent of annual demand Finished goods stock 10-50 per cent (4-26 weeks) of annual demand Supply chain cycle time-of-order 1,000 hours Value added time 0.3-5 per cent of cycle times Supply chain costs overtaking R&D costs The above-mentioned report shows that the pharma industry has a huge 36

potential to limit supply chain cost in the value chain, as supply chain costs are higher than R&D costs. Hence, companies should map their supply chain processes and optimise the same to ensure product availability at favourable costs. Optimising the supply chain would result in 30 per cent stock reduction, 30 per cent increase in value-added time and 7 per cent reduction in supply chain costs, which has been proved by one large drug manufacturer who reduced the supply chain costs up to $ 30 million with $ 816 million per annum.

Foreign Direct Investment (FDI) worth $ 1,825.43 million between April 2000 and September 2010, according to data published by Department of Industrial Policy and Promotion (DIPP).

The Drugs and Pharmaceuticals Manufacturers Association has received an in-principle approval for its proposed Special Economic Zone (SEZ) for pharmaceuticals, bulk drugs, APIs and formulations to be located at Nakkapalli Mandal in Visakhapatnam district, as per a government press release. According to Union Minister of State for Chemicals and Fertilizers, the Department of Pharmaceuticals has prepared ‘Pharma Vision 2020’ for making India one of the leading destinations for end-to-end drug discovery and innovation. For this purpose, it provides the requisite support by way of world-class infrastructure, internationally competitive scientific manpower for pharma R&D, venture fund for research in the public and private domain and other such measures.

According to a report by PricewaterhouseCoopers (PwC) in April 2010, India will join the league of top 10 global pharma markets in terms of sales by 2020, with the total value reaching $ 50 billion. The pharma industry has a tremendous opportunity to lower costs, improve asset management and enhance

The way forward

Table 1: Cost distribution in the pharma value chain The healthcare sector Value chain stages Cost distribution has attracted growing 15 per cent Research & development investor support in Primary manufacturing 5-10 per cent 2010 with nearly a tenth of the total Secondary manufacturing/packaging 15-20 per cent Private Equity (PE) Marketing/distribution 30-35 per cent funding leading to General administration 5 per cent this sector. In the Profit 20 per cent third quarter, calendar year 2010, a total of $ 2,047 million was customer service by implementing invested across 88 deals, of which 9 per supply chain best practices such as cent were healthcare deals, according to CPFR, outsourcing, Vendor-Managed the research firm Venture Intelligence. Inventory (VMI) and Lean thinking. The Further, in October 2010, the pharma, companies that adopt these practices will healthcare and biotech sectors witnessed gain a competitive advantage over their five M&As worth $ 250 million, rivals, and the costs & response speed according to the global consultancy will be in the orders of magnitude lower firm Grant Thornton. The drugs and than traditional methods. MPh pharmaceuticals sector has attracted (gopalakrishnan@cii.in) Modern Pharmaceuticals I February 2011

Green Practice

‘The logis cs sector cri cally needs an industry status’ …says Vineet Agarwal, Execu ve Director, Transport Corpora on of India (TCI). Along with the lis ng challenges in the pharma sector, he details the environment-friendly ini a ves adopted at TCI, while underlining the role of the government in overcoming the challenges faced by the logis cs sector.

Arshia Khan What percentage of your business comes from the pharma segment?

TCI offers its services of Express, Part Load, Full Truck Load (FTL) and reefer mode to the pharma sector, which contributes 3-5 per cent to TCI’s business. We offer customised solutions to all major pharma companies in their respective fields.

What are the challenges in the supply chain of pharma products?

The major challenge is continuously maintaining critical temperature during storage and transportation of pharma products, maintaining the delivery schedules and meeting deadlines. For this, a strong and effective cold chain network in required. In spite of the growth in the cold chain industry, there still exists a major gap in the supply and demand of cold chain in India.

This is because of the lack of adequate infrastructure and significant lack of temperature-controlled equipment and facilities. Poor packaging is another hurdle, as it leads to damages while handling.

The Bri sh supermarket chain Sainsbury’s expanded its trials of running vehicles on biogas made from landfill waste. Pepsi-Cola saved $ 44 million by switching from corrugated to reusable plas c shipping containers for one litre and 20-ounce bo les, 38

conserving 196 million pound of corrugated material. These are some examples of environmentfriendly prac ces adopted by companies. What measures does TCI have in place for energy conserva on?

TCI is making its own humble contribution towards environment protection and conservation of energy, use of renewable sources of energy, production of alternative source of energy, etc and is working towards going green, which is reflected even in its building, its architecture and the materials used in its construction. The company has taken a few initiatives for this, as listed further.

Effective fleet management for environment protection: Acquisition that is compatible and meets upgraded and evolving emission norms, older trucks that are not fuel-efficient are removed from the system, conducting fuel quality checks for ensuring proper mileage and emission control, disposal of lubricants, batteries, tyres and other materials that contain lead and other toxic elements to authorised recycling agents only to prevent unauthorised reuse, thereby ensuring controlled carbon emissions Energy conservation for reducing operating cost: Induction of CNG vehicles for city pick-up and deliveries, utilisation of railway services for bulk cargo movement, use of high-capacity vehicles, enabling more profits and optimal fuel consumption

Initiatives at TCI facilities: Initiatives such as rain water harvesting have been introduced in most of the facilities at TCI – Bengaluru, Rewari, Lucknow, Gurgaon, Pune, etc. All warehouses have 10 per cent transparent sheets on top or side to allow daylight in order to make use of natural light and save on electricity, solar energy is used for lighting and water heating, along with absorption technology for air-conditioning at the TCI corporate office.

Production of energy through alternative sources: We have entered the wind power generation in Rajasthan and Maharashtra, with an installed capacity of 11.5 MW comprising a 5 MW wind farm in Rajasthan and a 6.5 MW unit in Maharashtra.

How does TCI ensure the safety and efficacy of healthcare and pharma products during transit by roadways?

For pharma goods, the most important factor is time-sensitive temperaturecontrolled delivery. Timely deliveries are not possible with the loaded highways and the toll mechanism, where a vehicle needs to stop in every few kilometres. Another factor is lack of insurance cover on these types of products, which adds to the problems.

TCI offers state-of-the-art vehicles with imported reefer units for temperaturecontrolled pharma products. Vehicles are equipped with Global Positioning System (GPS)-based tracking system Modern Pharmaceuticals I February 2011

Green Practice and temperature data loggers to log the temperature throughout the journey.

How can the government help counter the obstacles faced by the logis cs industry during road transporta on?

Following are some of the major challenges faced by this sector: Fines and penalties: Lack of standardisation of fines and penalties levied by various state governments is a major cause of concern.

Lengthy documentation procedures: Due to inter-state sales tax-related issues and varying documentation requirements of different states, much time is wasted at the border checkposts in complying with the formalities.

No industry status to logistics industry: The sector is highly fragmented with 80 per cent of it being accounted for by the unorganised sector. Moreover, lack of ‘industry’ status for the logistics sector and absence of a single logistics ‘regulatory body’ in the government or industry has hampered the growth of the sector.

Lack of skilled manpower: There is an acute dearth of skilled manpower in the industry. Truck drivers form the backbone of the sector and, ironically, they comprise the most neglected and untrained set of workers. Lack of quality manpower poses an obstacle in adapting to modern technologies and management practices.

The logistics sector critically needs an industry status and the government should actively consider this matter.

The middle-level infrastructure warehouses, multi-modal logistics parks, cold chain, cross docks, toll collection system, check posts, etc are also not adequate in India and require a major focus and investments from not only the government but also from the logistics players.

What will be the growth drivers for the pharma logis cs industry?

India’s pharma industry is one of the fastest growing sectors in Indian economy. The industry has grown at well over 10 per cent over the last few years, and is expected to maintain the growth rate for the next few years also, which will increase the need for logistics. Logistics is regarded as a crucial part of the pharma industry since the activities are highly time-sensitive.

In addition, pharma products need temperature-controlled storage and distribution.

What are your future plans and strategy for growth?

We intend to grow by a compounded annual growth rate of at least 20 per cent for the next 4-5 years. We will be focussing more on product offerings and will introduce various new services. We have recently started new services like the rail cargo service, consultancy and a record management service. MPh (arshia.khan@infomedia18.in)

February 2011 I Modern Pharmaceuticals

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Green Practice

‘Pharma companies are increasingly recognising the need for integrated solu ons’ …says Christoph Remund, CEO, DHL Lemuir Logis cs Pvt Ltd. He highlights some of the emerging technologies and the environmentfriendly prac ces adopted by the company.

Arshia Khan How has the development been in the way logis cs providers have upgraded themselves?

In earlier days, drugs were transported in parts, with each leg of transportation handled by different service providers. Today, logistics providers have upgraded themselves and manage end-to-end transportation of temperature-controlled shipments. They also offer customs clearance at origin and destination to have control over the entire supply chain. Logistics providers have upgraded themselves in infrastructure, service and invested in understanding the needs of this sector, thereby providing suitable solutions to the industry. However, a seamless temperature-controlled movement is only possible currently by using either an active or passive cooling solution.

What has been the company’s business model? Who are the major clients in the pharma and biotech space?

Different pharma products – vaccines, serums, blood plasma, clinical trials, formulations, drugs, etc – require specific packaging. Hence, it is imperative to understand the kind of drug being shipped and how it needs to be stored, in order to preserve its efficacy. There are various validated active and passive cold chain solutions available, depending on the logistics requirements of the shipper. DHL would help customers understand what mode suits their needs best. Our customers include nearly all major MNCs and Indian pharma companies.

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How has the company contributed to the overall cold chain market?

In Asia, DHL is investing $ 15 million (` 72 crore) to strengthen the infrastructure to fulfill the growing demand for logistics services in the global life science industry.

To capitalise on the fast growing life sciences industry, we have launched Life Science Competence Centers in key locations in India and worldwide.

These centres augment DHL’s on-going innovations in the industry by filling in the gap in the existing supply chain, by providing improved temperaturecontrolled handling and storage, greater product transparency & visibility, and complete end-to-end logistics capabilities.

What about training the employees on handing these goods?

DHL has invested in imparting training to the personnel handling pharma shipments. The company is collaborating with its vendors to educate them on the needs of the pharma sector to devise and implement effective solutions. We are looking at investments in Human Resource (HR), as there is a need for continuous supply of well-trained manpower. Unfortunately, in India, universities and academic institutes do not focus much on logistics. At DHL, we invest in training our employees to ensure that they have adequate skills required for this sensitive industry.

Kindly elaborate on environmentfriendly prac ces adopted at DHL. Technology in healthcare has grown

drastically over the years. Pharma companies are increasingly recognising the need for integrated solutions in supply chain management to keep inventories at optimum levels. In this context, new and emerging technologies are being employed for smoother and efficient deployment of supply chain. Mechanical equipment like pressure gauges, thermometers and physical logbooks are being replaced with microprocess controls, transducers and automatic recorders. Increasingly, Wi-Fi cold storage monitors are being employed to control temperatures automatically.

DHL’s award winning innovative pallet shipper has been designed, based on the needs and requirements of the life science and regulatory sector. The state-of-the-art, fully calibrated testing facility is operated by Softbox Systems in the UK, and recently, the SoftBox facility has been set up in Mumbai.

Pallet shippers can be constructed as per the size of packages/pallets and temperature requirement. They have been engineered with high-performing, robust and reusable components that can be delivered flat-packed and are completely recyclable, translating to lesser impact on the environment.

LifeConEx, DHL’s specialised temperature-controlled transportation solution, systematically integrates and rigorously measures all supply chain partners to ensure proper storage, handling and distribution of temperature-sensitive medicinal products, delivering lesser delays, less cycle time, less temperature deviations and far fewer claims. MPh (arshia.khan@infomedia18.in)

Modern Pharmaceuticals I February 2011

Clinical Supplies Management

Clinical trial logis cs

Impera ves for India

Photo by: Mexy Xavier

As most materials used in clinical trial process are temperature sensi ve, these need to be stored within a speciďŹ ed temperature range, for being qualiďŹ ed for usage. A large share of the costs incurred in the trials is that of logis cs, which plays a key role in the en re process.

Thus, pharma companies can focus on their core ac vi es by shi ing the non-core ones on to a specialist for providing logis cs services.

M

aintaining the cold chain for drugs and biological & clinical trial samples has been doing the rounds in healthcare product packaging.

Today, more and more pharmaceutical products are required to stay within strict temperature ranges. There are approximately 130 million shipments of temperature-sensitive medical and other related products per year.

The contents of the shipment must be protected from thermal shock. For instance, blood, plasma, medicines, vaccines and pharmaceuticals cannot be allowed to become warm or exposed to fluctuating temperatures in transit, as they may either become spoiled or severely damaged. In these markets, the importance of the cold chain distribution process cannot be emphasised enough.

India: The outsourcing des na on

Sanjiv Kathuria Country Director- Sales & Marketing, TNT India Pvt Ltd

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Development of a brand new drug is a very complex, comprehensive and risky endeavour, with no final guarantee that the prospective new product might succeed and generate revenues. Imminent patent expiration and swelling R&D costs are forcing global pharma companies to revisit their operating paradigms. This has

led to globalisation of the clinical trials and the spotlight is now on improving operational efficiencies to sustain profitability. This has given a boost to outsourcing of pharma and research activities to low-cost destinations like India and China.

The cost of conducting clinical trials in India is 40-50 per cent of that in developed countries. Currently, there are approximately 150 Clinical Research Organisations (CROs) in India that include almost all top organisations operating at the global level. Most of these CROs have established world-class research laboratories in the country.

India, with its diverse genetic pool of patients, well developed medical facilities and skilled manpower, has become a prime destination for outsourcing of clinical trials.

Handling with care Logistics is a key element of the clinical trial process. It subsumes 20-30 per cent of the total cost of the drug discovery process. As the clinical trial materials are sensitive to temperature excursions and perishable in nature, the efficiency of the trial will depend on the efficiency of the supply chain in many ways, as the integrity of the clinical trial material is of utmost significance. Given its importance, the Logistics Service Provider (LSP) must be truly global and have established robust processes in place to facilitate the storage and distribution of clinical trial materials. The LSPs must have specialised manpower trained to handle clinical trial material with extreme care. They must have complete Modern Pharmaceuticals I February 2011

Clinical Supplies Management understanding and knowledge of the regulatory and customs compliances.

The cold chain distribution process is actually an extension of the Good Manufacturing Practice (GMP) environment that all drugs and biological products are required to adhere to, enforced by various health regulatory bodies. As such, the distribution process must be validated to ensure that there is no negative impact to the safety, efficacy or quality of the drug substance.

Responding to challenges India is one of the emerging markets for clinical trials and presents specific challenges. These include socio-economic issues, poor transport infrastructure, complicated regulatory environment and lack of understanding by local authorities.

Running the clinical trials with a less than ideal infrastructure is one of the biggest challenges in the country.

Shipping large volumes of refrigerated patient kits while maintaining and documenting appropriate temperature conditions creates a demanding distribution environment. Given the large number of clinical sites, there is increased complexity for maintaining product quality and mitigating the risk of thermal excursions.

This has further augmented the requirement of specialist LSPs with infallible and proven distribution processes to improve the performance of clinical trial supply chains. Many of the LSPs have responded to the changing market needs by building a framework of procedures and best practices for clinical trial logistics specific to Indian conditions.

This includes hiring skilled manpower and building facilities, cold chain network and organisational infrastructure in compliance with global healthcare quality standards, taking account of fundamentals of GMP, Gross Domestic Product (GDP) and ISO. Internal quality audit programmes and checks to ensure continual logistics process improvements are mandatory to match up to the market needs.

February 2011 I Modern Pharmaceuticals

Role of LSPs The LSPs have a crucial role to play in terms of the following activities: Customs and regulatory expertise: Clinical studies, being global in nature and transcending national boundaries, necessitate an understanding of local regulatory issues and multi-country customs & regulatory requirements.

Before a trial begins, the sponsor should work with a reputed LSP to identify the required permits and paperwork. There has been an increase in the number of global regulatory and guidance documents issued over the past few years.

The specialist LSPs have huge amounts of information on specific customs and regulatory requirements, which they browse through and advise the sponsor about. The LSPs have specialists who are proficient in handling multi-country trials and understand the customs and regulatory requirements; they also provide advice on best gateways to use for clearance and on where to have the storage facilities.

Contingency planning and control: Keeping the supply chain intact and continuing the trial even during contingencies is a critical requirement.

The logistics for clinical trials must be planned in a strategic manner, detailing the exact, accurate and current requirements for shipping to each temperature zone. The idea is to reduce the possibility of error and mitigate the risks involved. Contingency planning is a key element for successful conduct of clinical trial logistics and the LSPs in this field need to have a crisis management plan in sufficient detail.

Having control and visibility of shipments through the entire supply chain process is extremely important.

Real-time visibility of clinical trial material inventory and shipments is an effective instrument that helps take tactical decisions. The LSPs with their state-of-the-art IT tools can help the sponsors by providing real-time visibility, thus ensuring continuity of supply. This ensures that the sponsors and CROs are able to focus on their core activities while leaving the rest to the LSP.

Strategic alliance: While there is no commercial value attached to the clinical sample shipments, its importance in the drug discovery process cannot be gauged by this. Being perishable in nature, samples lost or expired during the transportation process cannot be re-created. This means loss of time with a disastrous impact on the cost of the trial. There is no room for error and the expected service levels are close to 100 per cent.

The LSPs have an important role to play by way of partnering with pharma companies and CROs for storage and distribution of temperaturesensitive clinical trial material. These services of an LSP include shipping, warehousing, customs clearance, logistics management, efficient record keeping, providing validated temperature-controlled packaging and refrigerated systems, as well as real-time monitoring and tracking. There must be an integration of the packaging system, the product and transportation route.

The different temperature requirements for the study and diverse external temperatures at different times of the year as well as at the origin and destination (requiring changes amid winter and summer configurations) create further complexity. This strengthens the need for a specialist for providing logistics services. As a result, pharma companies and CROs are now entering into quality agreements with LSPs.

The key element Increasing costs of drug discovery have raised the stakes for all parties involved in the clinical trial process.

As logistics is a key element of the process, partnering with a specialist LSP is a strategic decision with long-term implications. Working with an LSP having a global footprint as well as tried and tested best practices along with global quality standards mitigates the risks involved and reduces the time spent on non-core activities for a sponsor. MPh (sanjiv.kathuria@tnt.com)

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IT Mantra

IT intelligence for improved supply chain speed

Leveraging mobility and auto ID Enterprise mobility and auto-ID technologies are the missing link between a pharma company’s opera ons in real- me and its business informa on systems. Easy access to these technologies allows for much more func onal capability on the shop floor, in the field and in the supply chain.

It is generally true for all industry ver cals that these technologies increase supply chain speed.

It will also lead to a significant compe ve advantage in the case of the pharma industry.

T

he pharma industry is increasingly embracing the supply chain as a competitive differentiator. Trends in the supply chain management practices and the route to market options have begun to change the way business is done.

More and more pharma companies today outsource production globally.

Consequently, their products move

S Sridharan Managing Director, TAKE Solutions

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through multiple layers of distribution before they are available at a pharmacy or a healthcare facility. There is intense pressure on these companies to leverage their supply chains to bring about a fast turnaround of supplies to meet market demands.

This means that all stakeholders in the supply chain need to work closely to enable faster and leaner operations.

Further, pharma companies need to maintain regulatory compliance throughout their operations.

From a supply chain management standpoint, following are the challenges that impact its speed: Integrating compliance, especially product tracking and traceability, into all manufacturing processes and distribution touch points Removing latency of information without disrupting operations Adopting best practices to accelerate product flows in the supply chain Enabling new and more efficient routes to market Adopting innovative practices to drive product demand Like any other manufacturing company, a pharma company too looks to accomplish this while eliminating wastage and potential bottlenecks

that can threaten its efficiency and profitability. This is where mobility and auto-ID technologies are making a difference. Mobility eliminates wastage of time hidden in its business processes — and speeds up the entire supply chain.

Integra ng compliance without slowing-down opera ons The pharma industry has to adhere to specific and important mandates to ensure consumer safety, especially those related to product tracking and traceability. Counterfeiting, diversion, mishandling, mislabeling and unintended or mistaken administration of prescription drugs are major concern areas. The ability to track and trace products across all manufacturing processes and distribution touch points, right from the point-of-production to point-of-care, not only ensures product safety and security, but also supports efforts to improve productivity and profitability.

Automated track-and-trace systems, built around auto-ID technologies like bar coding and Radio Frequency Identification (RFID), now ensure that products can be uniquely identified with a serialised number that serves as a ‘fingerprint’ for only that particular bottle/package. Auto-ID technology allows instant verification for any drug, at any location in the supply chain. It also facilitates ‘no-touch’ track and trace capabilities to support true pedigree information about Modern Pharmaceuticals I February 2011

IT Mantra drugs, and this information can be accessed by all supply chain partners.

Industry experience indicates that these capabilities constitute strong barriers for potential counterfeiters to overcome.

Companies are now using these technologies to easily refine dominant industry practices to embrace compliance, without slowing down operations in the supply chain. These technologies also provide unprecedented control and efficiency for recalls, returns processing and inventory control.

Elimina ng latency Many pharma companies today rely on their enterprise systems to help them make the smartest use of effort and resources, but the process of manually entering information into the appropriate forms can be a drain on productivity.

Workers – whether on the shop floor, in the warehouse or on the shipping dock – must interrupt the flow of work to key information into a form, or wait until they have completed an activity to update the system. Both approaches are error-prone and compromise the accuracy of the enterprise record. Also because enterprise software can be difficult and expensive to customise, many companies are often forced to adapt their processes to fit existing functionality — jeopardising any competitive edge resulting from unique, innovative business practices.

With many companies relying on logistics service providers for physical distribution, the problem of latency acquires larger proportions on account of the varying levels of their IT savviness, and orchestrating collaboration across multiple organisations.

Rather than manually entering information into enterprise systems, with enterprise mobility solutions, workers use handheld barcode and RFID scanners to collect information and complete transactions on the spot. Rules-based guided put-away and picking enforces compliance with inventory policy and optimises warehouse traffic. Companies would also be able to use these solutions to February 2011 I Modern Pharmaceuticals

streamline cycle counts, WIP pulls and labelling activity with advanced functionality that supplements the existing ERP capabilities without costly modifications.

Improving delivery mes Cross-docking is a popular strategy for Third Party Logistics (3PL) providers and organisations with extensive distribution networks. The practice of immediately converting inbound deliveries to outbound shipments offers significant financial and operational advantages. Effective crossdocking requires continuous real-time visibility of shipments as they move from the factory to the end customer.

Unfortunately, even with warehouse management modules supporting cross-docking installed, traditional ERP technology does not offer real-time visibility and accountability to optimise cross-docking efficiency.

Without the ability to track shipments on a real-time basis down to the level of individual bottle or package, companies can lose control over inbound and outbound materials, thereby increasing the potential for duplicate shipments, delayed shipments and other errors that can offset any gains in efficiency.

This functional technology gap poses a significant challenge for 3PLs and distributors. Without tracking and tracing capabilities designed specifically for cross-docking, companies risk building up excessive inventory and incurring the administrative overhead required to receive and process ‘rogue’ shipments.

Auto-ID technologies coupled with mobile technologies allow drivers, shipping and receiving personnel to scan inbound and outbound shipments slated for cross-docking. The handheld devices communicate directly with the tracking database in real-time via a wireless connection or, alternatively, store scanned information for batch uploads to the database at a later time.

The devices also feature applications that enforce predefined receiving, delivery and cross-docking parameters

designed to minimise shipping errors and subsequent returns.

Alterna ve routes to market While most pharma companies rely on the traditional wholesale distribution channel, companies across the world have begun to leverage information technology to ship direct-to-pharmacy or even direct-to-patient. A direct channel gives the company more control over the inventory – versus ceding inventory control to wholesale distributors – while helping to reduce returns and keeping costs low. However, it also increases the administrative workload. Direct distribution requires increased real-time visibility and control across all nodes/ touch points in the supply chain, and this is again enabled by auto-ID and mobile technology capabilities.

Accelera ng demand Some of the more successful pharma companies today are using mobile technologies to overcome the limited amounts of time that physicians are willing to spend with their sales reps, enrich the interactions and drive increased prescriptions for their products. These solutions help their sales personnel perform pre-sales planning, on-the-road preparation, and post-meet follow-up activities related to a meeting with a physician.

In addition to complex planning tasks like goal setting, calendar management, route planning and researching customer issues, these solutions enable on-the-go look-ups for updated information about comparative drug efficacy, interactions, contraindications and adverse effects. Companies have also extended capabilities to perform related activities like filing in meeting summaries and expense reports using these technologies. Of late, these solutions are also helping to provide information to strengthen the personal bonding between medical representative and the physician, as well as enabling a new selling paradigm of collaborating with colleagues in real-time. MPh (managingdirector@takesolutions.com)

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IT Mantra

Towards an ideal supply chain

Need for a re-haul IT remains an important factor in tracing the goods during transit. A smart approach should enable track and trace of products any me, which may be possible with high-end IT services.

An insight.

T

he Indian pharma industry has grown by leaps and bounds over the last few years. India is now the third largest country in terms of volume and 14th largest in terms of revenue all over the world. Along with increased domestic consumption, India exports to a number of countries and accounts for 31 per cent of Drug Master Files (DMFs) filed with the US Food and Drug Administration (USFDA). Thus, India has grown from a small drugs manufacturer, hardly able to sustain

itself, to a country that has fast become the manufacturing hub for drugs supplied the world over.

However, the supply chain has still not evolved to match with world-class standards. It is estimated that 45-55 per cent of a drug’s market cost is its logistics expenditure. In a country where the pharma industry is becoming extremely competitive, the pricing is crucial for survival of the industry.

Also, a well-organised supply chain becomes a sustainable competitive advantage, thereby increasing the bottom line and increasing the marketshare of a company.

Supply chain constraints

Rajesh Kumar President, Pharmaceutical Packaging Innovation, Bilcare

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Even though India has emerged as a manufacturing hub for pharma companies all over the world, the supply chain model has not changed much with the evolution of the companies. They are still using the

traditional system, which has a very high dependency on middlemen.

Following factors hinder supply chain development: The conventional supply chain model pushes companies to manufacture based on forecasts and internal requirements, ie, an internal focus Manufacturers are not connected to consumers directly and are largely dependent on middlemen for market information They tend to look inwards and manufacture based on their own requirement rather than market needs, which limits their potential and production. This increases wastage and downtime, thus affecting the final profitability of the organisation This mindset affects the entire supply chain, forcing the members in the supply chain to focus on their own needs rather than the needs of the market/end consumer In certain cases inventory management is inefficient. Since manufacturing companies are unable to track and trace the entire supply chain, they are unaware of the requirements of the supply chain members, except for wholesalers and distributors.

Thus, they cannot impose any minimum order quantities on the chain, which would enhance the efficiency of their production Without any set order quantities, companies tend to either over-stock or under-stock, both of which result in increased expenditure With the huge numbers of players in the supply chain, it is difficult to control the entry of counterfeit drugs Modern Pharmaceuticals I February 2011

IT Mantra An ideal supply chain scenario Flow of goods

Informa on flow

Vendor Manufacturer Manufacturer Vendors Central warehouse Distributors/wholesalers Distributors/wholesalers Stockists Stockists Retailers Retailers End-consumer

in the chain. An estimated 15 per cent of drugs available in the Indian market are counterfeit.

Advantages of the proposed model An organised supply chain will help pharma companies connect directly with the patients/end consumers and improve their corporate/brand image.

A well-managed and thought out supply chain will enable companies to maintain the correct inventory level, free capital that would have been locked up in inventory, deliver goods on time and allow for a faster cash turnover. It will also allow companies to think laterally and beyond their requirements. This, in turn, will help them manufacture in optimal batch sizes, reducing their wastage and downtime. It will also broaden the scope of the entire supply chain, increasing profitability and growth of the pharma industry.

With a better tracking system, manufacturers will remain connected to all members in the supply chain.

They can procure information from every part of the supply chain directly, including from end-consumers Manufacturers can forecast more efficiently, plan their inventories and optimise their batch sizes. All of these February 2011 I Modern Pharmaceuticals

End-consumer/pa ent

will increase the control available with the pharma company Companies can observe order quantities made by stockists and retailers, enabling them to create a minimum order quantity based on the average for wholesalers and distributors The new system will also allow them to better handle goods diversion since they will be able to check where the goods are going A strong connection between consumers and manufacturers will deter counterfeiters from entering the chain Manufacturers will base their production on a replenishment and consumption model This model will include a ‘Central Warehouse’, which will send the goods to wholesalers/distributors and stockists. This warehouse will stock goods based on information collected from them Central warehouse will also trigger the manufacturer about any dip in the ordering level (consumption), thus allowing pharma companies to better control their own ordering.

nonClonable security technology Bilcare has developed a nonClonable

security technology that is designed to be user-friendly and to help consumers identify whether a product is genuine or a counterfeit. The tag assigned to a particular code cannot be copied.

The solution is also designed to help companies build their relationship with the end-consumers and improve patient compliance.

This technology is also enabled with a track-and-trace function. Every time the product is swiped or the barcode is read, the data is stored with Bilcare.

The tag can only be read with Bilcare’s nonClonable Reader. Each reader is assigned a unique code and is activated once all required details are provided to the company by people who handle the reader. Thus, pharma companies will be aware of the name, location and mobile numbers of the pharmacists selling their medicine.

The nonClonable ID security employs a unique materials-based fingerprint for each product that is prohibitively difficult to copy.

These materials-based fingerprints are applied as tamper-evident labels directly on the product or on the packaging. This technology makes it possible to authenticate a product as well as track and trace every product, if needed. MPh (rajesh.kumar@bilcare.com)

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Trace Value

Securing the supply chain

Ensuring profitability Due to increasing incidence of spurious drugs, mishandling and other such occurrences, stakeholders in the pharma supply chain – from point of produc on to point of care – recognise the importance of traceability. Not only does traceability contribute to product safety, but also supports manufacturers’ efforts in improving produc vity and profitability.

Coding for quality

I

ndustry concerns about counterfeiting, diversion, mishandling, mislabelling and unintended or mistaken administration of prescription drugs are mounting at an unprecedented pace. Interest in, and adoption of, automated track-andtrace systems like barcoding and Radio Frequency Identification (RFID) has grown swiftly.

As policy-makers move towards electronic pedigree (e-pedigree) adoption, the industry is progressing closer to that goal. Early experiences with barcoding and RFID across various stakeholder groups demonstrate the opportunities and challenges inherent to securing the pharma supply chain.

Production management, enterprise resource planning, environmental health & safety monitoring and other systems frequently provide or require lot-level traceability.

Extending batch-level traceability to the final product at the unit-dose would maximise quality management and safety benefits. Thus, RFID makes it practical to provide traceability at any packaging level. In regulated environments where traceability is required, entering data with Automated Data Capture (ADC) technology, such as barcode or RFID, is highly advantageous, as it creates 100 per cent accurate electronic records.

Industry experts anticipate that in the near future, paper pedigrees will be bypassed altogether in favour of electronic records.

Drivers of traceability solu on Andrew Tay President - Asia Pacific, Zebra Technologies

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Following trends are driving the development of track-and-trace solutions in the pharma supply chain:

Governmental and regulatory agencies are exerting pressure to ensure medication product security Providers are becoming concerned about quality of care and patient safety, including secure administration of correctly barcode-labelled medications to patients Suppliers are seeking economical and effective methods to support manufacturing operations, control inventory and manage recalls/returns Spotting these efforts, the FDA recommended a solution in 2004 by introducing its barcode rule to improve tracking for recall and inventory management.

Since the FDA rule took effect in 2006, manufacturers have marked thousands of drugs and human biologic products with a barcode on the unit-dose packaging. New drugs must carry unitdose barcodes within 60 days of their FDA approval date.

The FDA requires the National Drug Code (NDC) number to be printed as a linear bar code. Two-dimensional (2D) barcodes and RFID tags cannot be used in place of the linear barcode. The FDA acknowledges that encoding lot numbers & expiration dates could improve recall management and it permits – but does not require – this information on the barcode.

Barcodes with lot numbers and expiration dates make it easy to record the information accurately. The healthcare industry spends $ 23 billion annually on order management, distribution, transportation and inventory management. Approximately $ 11 billion of these costs are unnecessary Modern Pharmaceuticals I February 2011

Trace Value – caused by redundant, non-value-added activities. In fact, prior to 2004, only 30-40 per cent of medicines in unit-dose packaging with barcodes were available. This figure has increased significantly since then. The FDA accelerated adoption by pointing out that the benefits of barcoding would be realised across the supply chain. In 2004, the agency estimated that 478,000 adverse drug events could be prevented and $ 93 billion could be saved in medical costs over 20 years as a result of barcoding.

Supply chain opera ons Many professionals are equally enthusiastic about the benefits that RFID can bring to inventory management and supply chain operations. Since RFID improves both security and product handling, it may soon find a permanent place in pharma packaging. RFID labels can be read through multiple layers of packaging without operator intervention, which can reduce the labour and time required for product handling in the supply chain. The EPC RFID system (managed by EPCglobal, Inc) creates a unique serial number for each RFID chip, which can be used as a digital birth certificate to uniquely identify identical units of the same product.

The US Department of Defense, Wal-Mart, Target and other big pharma purchasers are providing an additional catalyst to RFID use by asking their suppliers to place RFID tags on shipments.

Recall management The effectiveness of recall management is a direct result of product information visibility in the supply chain. The amount of information included on pallet, case, carton and unit-dose packaging can eliminate the general, mass recall with notices going out in newspapers and on TV news, in favour of a highly targeted, limited recall where consumers may receive notification by a phone call from their own pharmacist or doctor.

Returns management Variable information unit-dose printing could have similar effects on everyday business such as returns management. The pharma industry handles returns worth $ 2 billion annually, according to a study by HDMA. Poor recordkeeping and the inability to provide audit trails in reverse logistics create inefficiencies and generate losses from otherwise acceptable products that cannot be redistributed.

Product authen ca on The FDA recommends that at least two forms of security be used on packaging. Many of the available technologies are complementary, so unit-dose bar codes and RFID identification labels can also provide anti-counterfeiting protection, especially when produced on secure media. MPh (andrew@zebra.com)

February 2011 I Modern Pharmaceuticals

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Management Mantra

Risk management in logis cs

Integra ng the supply chain Organisa ons become vulnerable if risks in supply chain management are not iden fied and con ngency plans are not developed at me of crisis. Thus, decision-making ac vi es of risk management process must be applied to the supply chain to recognise and mi gate a threat.

T

he term ‘Supply chain’ includes all suppliers who are important to an organisation and its products and services.

Therefore, the interface and relationship among and within organisations and their suppliers is important in understanding and identifying potential risks to the quality of products & services and, ultimately, the end-user.

Cold chain refers to a system of storing and transporting the products within the recommended safe temperature range (frozen, refrigerated or controlled environment). Maintaining the cold chain is essential, as products that are temperature sensitive can become less effective or even get destroyed if exposed to a temperature above or below the recommended range. The loss of product effectiveness is cumulative and cannot be reversed.

Risk management Risk management is defined as a systematic process for the assessment, control, communication and review of risks across the product and service lifecycle. The level of effort invested may vary from case to case, but essentially should commensurate with the specific risk.

Ajit Tamhane Director, Lisaline Asia Lifesciences Technologies Pvt Ltd

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Risk assessment Risk iden fica on Risk analysis Risk evalua on

Risk review Review criteria Measurement tools Feedback of the review

Risk control

Risk management

Risk reduc on Risk acceptance

Risk communica on Internal stake holders External stake holders Who/What/When/How?

Risk assessment encompasses several aspects that help in determining the quantitative or qualitative value of risk related to a concrete situation and a recognised threat.

Risk identification: The purpose of the risk identification stage in the overall process is to determine ‘What can go wrong?’ It is defined as ‘a systematic use of information to identify hazards referring to the risk question or problem description.’

Hence, risk identification is a starting point and forms the foundation of the entire risk management process.

Risk analysis: This step attempts to estimate the level of the identified hazards and risks in terms of severity of harm and the likelihood of occurrence & detection. It provides a quantitative or qualitative estimate of

each risk. There are various tools used to analyse the risk – like a ‘qualitative’ tool, such as risk ranking, and a ‘quantitative’ tool, such as Failure Mode & Effects Analysis (FMEA) and Cause and Effect matrix (C&E).

Risk evaluation: It compares the identified and analysed risk against the given risk criteria. To achieve this, a level of tolerable risk must be defined against which the risk analysis output can be compared. Risk evaluation allows the decision making step of risk control.

Risk control It involves decision-making activities that result in action, ie, reduction of risk. Risk control has a wider ambit than risk management. Risk control is a process of procedures, policies Modern Pharmaceuticals I February 2011

Management Mantra and systems that an institution or organisation needs to manage the risks. This process contains some key elements like: Risk reduction: This process agrees to take action to reduce and avoid the identified risks, including allocation of resource and investment where appropriate. The risk reduction step focusses on processes for control or avoidance of risks.

Risk acceptance: This process is a decision taken by an organisation to continue to operate without any action to reduce a given risk. The purpose of risk acceptance is to formally record the decision by senior management and communicate to the business and relevant stakeholders.

Risk review Risk review is required to ensure that the results of the risk management process are periodically re-visited and actively evaluated in response to events and new information. It is about being able to demonstrate and verify the status and effectiveness of risk management.

There are immense benefits of risk management that includes improving business relationships between suppliers and customers, potentially reducing costs, minimising cost of compliance, improving business efficiency, increasing confidence, reducing liability as well as avoiding waste and scrap.

Risk communica on

Proposed solu on for risk management

Risk communication is an effective internal and external communication critical for the success of any risk management process and is an ongoing part of the risk analysis exercise.

Communication and consultation with internal and external stakeholders as far as necessary should take place at each stage of the risk management process.

Table 1 shows an example of the process of risk management in which there was a lack of temperature data at various facilities as well as during transportation. Hence, the action proposed for risk reduction was to select a complete data-logging solution that can cover temperature monitoring of the following areas. The internal facilities including manufacturing,

Risk control

Risk assessment

Table1: Process of risk management Tool Details Critical process Maintaining cold chain product within desired temperature range Critical process Temperature range, eg, 2-8°C parameters Risk event Deviation from temperature range, 2-8°C Potential hazards Identify risks with product quality, customer safety, business, etc Risk ranking High risk Tolerance level Specify tolerance, eg, >8°C, for 30 minutes Component Details Policy decision Maintenance of temperature Actions required Temperature monitoring of facilities and transportation Resources For equipment, facility improvements Involvement Organisation roles and responsibilities

Risk identification

packaging and cold room stores; and external facilities including cold rooms at distribution centres, transport vehicles, etc. The technologies used are wireless data-logging system with real-time multi-location monitoring and Global Positioning System (GPS)-based monitoring.

Configuring the system For configuring the system, some factors must be considered. Wireless data loggers with temperature sensors are placed at each measurement point spread all over the territory for temperature regulation at the facilities.

Radio receivers are installed at every location to receive data from the data loggers at user-defined intervals. All these locations are connected by LAN and WAN or through Internet.

For monitoring the temperature of refrigerated vehicles, wireless data-loggers with sensors for temperature control are placed in the refrigerated compartment of each vehicle. The GPS-based communication box linked with the radio receiver facility is placed in the driver’s compartment, and the GPS modules are configured with a server.

The deliverables include real-time temperature data of all cold rooms at user-defined intervals; multimedia alerts via telephone, fax, email, hoofer, etc; fleet management and temperature data of refrigerated vehicles on move and automatic reporting with audit trail for risk review.

Taking the right ac on Risk analysis Risk evaluation

Risk reduction

The risk management process is an ongoing cyclical process, which includes a systematic approach to control or eliminate critical risks as well as identify any new risks. Appropriate actions should be taken based on the output of risk management process. For cold chain, it is necessary to select the right technology that is easy to use, as well as expandable and adaptable both for facilities and transportation vehicles. This helps in proper integration throughout the supply chain. MPh (ajit.tamhane@lisalineasia.com)

February 2011 I Modern Pharmaceuticals

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Pharma Logistics & Aviation

‘We work in partnerships and we rely on our partners’ …says Carsten Hernig, Regional Director, South Asia & Middle East, Lu hansa Cargo. Lu hansa has recently launched its ‘Op cooler’ for temperature-sensi ve products. Hernig outlines it usage, and the opportuni es Indian pharma industry.

Arshia Khan Please elaborate on Lu hansa Cargo’s deal with GMR. The benefits of this tie-up majorly lie on the client’s side. We are seeing this from the client’s perspective, as we are in the service industry, and we can be successful only if we are able to fulfil clients’ requirements.

Clients in Hyderabad deal with sensitive pharmaceutical cargo, which necessitates a seamless transport chain of high quality, which cannot be 95 or 99 per cent, but a 100 per cent. Thus, we needed a partner with the right infrastructure to guarantee the same. And we found this with GMR and hence have tied up with GMR International Hyderabad Airport.

It also has a first-of-its-kind pharma zone, which gives us the space to store the containers not only for packing but also for maintaining the desired temperature for the safety and efficacy of products. With the pharma zone and other infrastructural benefits of the airport, we can guarantee a seamless transportation chain on one hand as well as the availability of containers. This is an advantage as in the transportation industry – sea freight or air freight – the availability of loading units is always a problem due to the imbalance in the traffic flow.

Positioning containers at the Hyderabad airport gives us a unique opportunity in the Indian market, since we always have containers at hand, and the clients will not have to wait. This reduces the time to market for the clients, and is one of the biggest benefits to them, which would decrease the 52

cycle and transportation time, ensure an unbroken chain and, of course, Lufthansa will also provide the global network.

This is a huge advantage not only for the pharma industry but for other industries as well, in India. We cater to over 300 destinations worldwide. With this we will be connecting one of the key industries of India with the rest of the world. Our aim is to focus on the needs of clients and for this we consult the customer advisory board as well as individual clients, because we believe bringing a product to the market, which is unacceptable to the client, is of no use.

The physical infrastructure at many of the airports is still insufficient, which needs to improve. Second, the processes at airports are unable to support fast cargo flow. We would need the opportunity to provide for such types of containers not only to airports but to the factories as well. So that a company can produce the drugs, load them on temperature-controlled containers and then move the units to the consignee. This is not possible at present due to regulatory and infrastructural issues. Resolving these issues will help India to connect with the world as if it was next door.

You have launched the Op cooler. Will this be manufactured in India?

What kind of investments are you looking at in India?

Opticooler is produced by a German company with which we have a contract and it is designed in partnership with Lufthansa.

We shared the requirements of the container for manufacturing. But we will only manufacture it in Germany, as the factory is there and also because it is a masterpiece of the German design.

We are in the airline business. We do not invest in infrastructure or roads. We invest in planes and containers – like Opticooler. We work in partnerships and we rely on our partners because we do not run the airports. We need to jointly work with our partners to develop processes that satisfy our customers.

What are the problems that you have iden fied in cold storage facility and SCM in India?

What kind of a business model will be apt for the Indian pharma industry?

The development of Indian pharma market is good. It is reaching the global markets not only with generic drugs but also with branded drugs. Now since the FDA and other regulatory approvals are given to Indian factories, there is a huge scope for expansion in the future. Obviously, India is a cheaper place for production than the US and EU, so the potential is huge. But, the challenges in the supply chain are multifold.

The development seen in India over the past few years has been extraordinary in a positive sense. We talk often about China but, actually, the developments in India, considering from where we come from during that period is outstanding. As far as a business model is concerned, infrastructure projects involve huge investments. Possibly a state or an individual investor may not be able to provide such amounts of money.

I think, in principle, a PPP will work in India, Modern Pharmaceuticals I February 2011

Pharma Logistics & Aviation and it has been proven successful also. Some examples of this model are Hyderabad and Delhi airports, which are functioning very well. With regard to customers’ needs, we will invest in additional facilities and technologies.

At present, we need to get people in the industry: forwarders and the airlines come together and identify the problem areas and inefficiencies in the processes. This is important for achieving a faster transportation chain with lesser worries. Everyone in the logistics industry prefers an efficient and less bothersome service.

Please iden fy top five countries that hold poten al, besides India and China.

At present, we see growth in South America, which is a very fast growing economy.

Another region in Asia where we see development happening is Bangladesh, which is currently driven by textiles and not highquality goods. There are also developments in traditional markets, ie, Germany, which is a fast growing nation on a global scale. We

February 2011 I Modern Pharmaceuticals

are also seeing global markets like Japan and Korea bouncing back.

How much business do you an cipate coming from the Indian pharma industry?

We expect a double-digit growth in the global markets on a year-on-year basis. At present, our flights from Hyderabad are the only carriers to Europe. Pharmaceuticals constitute approximately 70-75 per cent of the production we get from here. This figure itself gives an impression of the significance of this business. It must be kept in mind that about 10 years back, the total uplift from pharma – ship or airlines – was nothing but textiles.

What are your future plans in India?

We are operating with all networks with freighters. Therefore, we are looking at stabilising our product and increase the opportunities, in terms of increasing frequencies. We are also planning to develop some fast transportation lanes to India where we are already firmly

established, what we call as Express Lanes in the industry. These will be the new catchment areas, ie, new airports to operate. There are a few cities in India, which are developing fast and are driven by the pharma industry.

One of these cities could be Ahmedabad where a lot of development is happening.

Therefore, we are keeping a watch on all these cities and, at one point of time, we will have to take an entrepreneurial decision. We are just keeping an eye on all this right now.

Your opinion on a SCM model for India India has the advantage of being a low-cost production region as compared to the UK and the US. Thus, the challenge here lies in having a reliable supply chain that fulfils 100 per cent regulatory requirements of import agencies like the USFDA,UK MHRA, etc.

If India manages to have a proper certified production line in the country, and a proper transportation line from airport to seaport, only then can it reach the target. MPh (arshia.khan@infomedia18.in)

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Pharma Logistics & Aviation

‘Working in an electronic environment will bring opera onal efficiency’ ……says Keki Patel, Cargo Manager - India and Nepal, Emirates Airline.

He highlights the advantages of E-freight, the importance of cold chain and growth drivers in the air cargo space.

Arshia Khan What kind of business oppportuni es do you foresee in the pharma logis cs space, as exports in this area are expected to grow at a CAGR of 18.5 per cent from 2007-08 to 2011-12?

Emirates will play a major role in air transportation of pharmaceutical supplies across its network to reach markets and destinations in a timely manner and handled during the transportation as per customer specifications. We have the capability to increase the pharma uplift contribution according to customer requirements, as we have 184 services a week from India to our Dubai hub. We offer a total capacity of over 13,000 tonne a month.

Various reports highlight that air freight will face underlying higher demand marred by over-capacity and weaker margins. What is your take on this?

Emirates SkyCargo uplifted 87,706 tonne of cargo out of India between January and November 2010, recording a 30 per cent increase in the outbound load uplift over previous financial year. Our outbound capacity utilisation is over 83.1 per cent for India operations for this financial year, an improvement over last financial year when we averaged 78 per cent utilisation.We provide a value for money service. Thus, it is up to the customer to decide on the service partner and the benefits that go in the process of selecting a carrier.

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What issues do you face while handling temperature-sensi ve goods?

Emirates SkyCargo offers special cold chain solutions, designed specifically for the movement of temperature-sensitive commodities such as pharmaceuticals, vaccines and perishable goods. The airline also offers specially designed temperature-controlled air cargo containers that maintain stable interior temperatures throughout the journey.

It features active temperature control systems that range from -20°C to +20°C. In addition, we have teamed up with a leading US research institute to develop a low-cost, light weight, breathable and reusable protective ‘White Cover’ designed to shield temperature-sensitive shipments from heat during airport to airport transportation.

How can air cargo improve service quality, reduce costs and inventory?

Several initiatives are available to reduce cost, with the most recent one being an adaptation to the E-Freight and E-Air Waybill (e-AWB) mode of paperless transaction with benefits for all, including the cargo forwarder and saving the environment.

How will E-freight help Emirates SkyCargo reduce costs?

E-freight replaces the old paper-based AWB with electronic documentation.

The forwarding agent transmits the AWB data to the airline. As soon as the airline confirms receipt of the shipment with

an event called Received From Shipper (RCS), the air freight agreement is considered concluded. This process helps to reduce paper cost, improves real-time information across the logistics chain, brings in more transparency, improves and enables better security compliances, etc for all (eg, shipper, forwarder, custodian, ground handler, airline, customs, etc).

How is security in air cargo ensured

by Emirates SkyCargo?

All of our cargo is passed through X-ray before acceptance for carriage.

Emirates ensures that valuable cargo are always safe and secure, right from acceptance through to final delivery at the destination. Specially developed containers, highly secured storage areas and constant surveillance guarantee the highest level of security for our customers’ valuables.

What will be the growth drivers in air cargo?

The Indian air cargo industry has been witnessing growth since the end of last year and the overall scenario is positive.

The future of India’s air cargo is bright, but it will take 2-5 years more for the business to really ripen. As the present infrastructure projects are complete, the constraints will also reduce. The challenge then will be to keep pace with the growth and manage the lows and highs. The arrival of retailers like WalMart, Carrefour, etc will boost consumer merchandise and purchasing demand.

Modern Pharmaceuticals I February 2011

Pharma Logistics & Aviation What are you most concerned with in terms of future challenges?

The price of fuel is something that all airlines must pay close attention to.

We have the most advanced commercial aircraft in the skies and its fuel efficiency was a major factor in the decision to grow our fleet with the aircraft.

The issue of avia on and the environment seems to be perpetual. Does the industry have the right strategy for the years ahead?

We will focus on our capabilities and efficiencies to bring value to our customer and build long-term business opportunities, wherein revenues are very much part of the business.

Pharmaceuticals is one sector that we are concentrating on. We are well placed to handle such special cargo – excellent 7,000 m² at Dubai Cargo Mega Terminal, Cool Dollies for direct unit load ramp transfer from aircraft to aircraft, Envirotainer temperature

February 2011 I Modern Pharmaceuticals

guaranteed transportation from origin to destination point, etc.

What have been your investments in the past two years?

In managing its profitable growth, we recognise the strategic value of E-freight.

Working in an electronic environment will bring enhanced operational efficiency and improvement to the supply chain. E-freight is an industry-led project involving carriers, freight forwarders, ground handlers, shippers and customs authorities. It aims to take the paperwork out of the air cargo supply chain, streamline processes, improve speed and reduce costs. Several factors contribute to these positive results: reduced cycle times of 24 hours on average, greater reliability and accuracy due to one-time data entry at the point of origin, and much better visibility in the online track on account of electronic documentation.

Emirates is an advocate of E-freight and is already one of the leaders in the industry in actual numbers of shipment

carried on the E-freight lanes, as we believe that E-freight is the future of our industry. By reducing paper and carriage of paper on aircraft, E-freight will help reduce errors and increase accuracy.

Your perspec ve on airlines changing and improving post Air Transport Associa on (IATA) Chapter 17 implementa on...

The new handling requirements specific to the pharma industry introduced by the IATA for air transportation are with the view of enabling a standard of consistent good handling practices by carriers to its customers in ensuring product safety. However, there are responsibilities for all in terms of compliance – shipper, forwarder, ground handler, airport custodians and carriers.

What are your targets for the next year?

We hope to achieve a 20 per cent growth in our revenue. MPh (arshia.khan@infomedia18.in)

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Pharma Logistics & Aviation

‘We were swi in understanding the pharma market and responded by crea ng the pharma zone’ …says Hemanth DP, COO, Airports Sector, (Hyderabad, Delhi, Maldives) Hub Development-Cargo Avia on Service FTWZ, GMR Hyderabad Interna onal Airport Ltd & Delhi Interna onal Airport Pvt Ltd. He speaks about the strategy for tapping the pharma hub by establishing a pharma zone, and its importance.

Arshia Khan Is the pharma supply chain of in India at par with the global standards?

Indian pharma industry faces many challenges in supply chain logistics.

India ranks 47th in the Logistics Performance Index (LPI: Survey 2010). And this is because of various reasons like inefficiency in handling of temperature controlled goods, high cost of reefer trucks, lack of infrastructure, poor netwok connectivity and poor ware housing facilities, etc. Ideally, all airports/seaports should have temperature-controlled handling to support pharmaceutical movements.

Companies should use reefer trucks while transporting their freight from factory to air/sea cargo terminals. It is advisable to have a monitoring and governing mechanism to ensure that shipments needing temperature control should move only in temperaturecontrolled vehicles on roads and the cold chain should not be broken at any point in between manufacturing point and the temperature-controlled ‘pharma zone’ handling facility at the cargo terminals.

As the consequences of breaking this supply chain are serious for the end users of the drugs as well as reputation of the pharma companies and the country’s industry in general.

Rajiv Gandhi International Airport (RGIA) Hyderabad is the first airport in India to facilitate dedicated temperature handling for pharma products.

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How does pharma zone at Hyderabad complement the Indian pharma industry?

Hyderabad is the pharma hub of the country with 70 per cent of the exports being pharma products. We at Hyderabad Airport were swift in understanding the pharma market requirements and responded by creating the ‘pharma zone’ facility. Hyderabad is strategically located in the centre of the country and with the first-of-its-kind facility of ‘pharma zone’ commissioned at our terminal, it is in a strong position to handle and serve not only local and nearby catchment area exports but also serve countrywide customers.

The world over various life-saving medications and critical ingredients from the pharma industry require appropriate storage during manufacturing, transportation, at transit points as well as in local pharmacies. India, particularly Hyderabad, is emerging as an important pharmaceutical manufacturing centre. For supporting the growing local industry, which now has strong global footprints, we as the logistics enablers have to extend accurate and temperature-controlled care while handling pharmaceutical products.

At RGIA Hyderabad, we are equipped to handle pharmaceutical exports from local and nearby catchment area and also extend across south and central India. We strongly believe that the newly created ‘Pharma Zone’ at Hyderabad will be utilised to its optimum capacity within a short span. Provisions for

future expansion have been envisaged keeping in mind the robust growth of the pharma industry.

What was the ra onale behind your e-up with Lu hansa Cargo?

Lufthansa Cargo and GMR group have signed a MoU to promote RGIA as a South Asia Cargo hub, especially in the pharma supply chain. Lufthansa would support the terminal with increased wide-body freighter frequencies, capacities and their sophisticated state-of-the-art temperature-controlled transport solutions, such as the new ‘Opti Cooler’ containers for time and temperature-sensitive pharmaceutical products. Lufthansa has recently sent its Quality Experts for conducting an audit of our new Pharma Zone and to rate Hyderabad Cargo Terminal’s capability. Lufthansa has further stated that it would be promoting Hyderabad as its hub for importing cargo as well.

What kind of diligence was done before you zeroed down to the Hyderabad airport?

We have initiated a unique process at our airport called Voice of Customer (VoC), whereby we interact with all our stakeholders and customers such as exporters, importers, freight forwarders, customs house agents and airlines and ask them directly: What is that we can do to make our service better? What additional infrastructure, technology, innovative solutions, etc that may be Modern Pharmaceuticals I February 2011

Pharma Logistics & Aviation required to improve our service offering?

We ask the customers: What we should ‘start doing’, ‘stop doing’ and ‘continue doing’. Besides, who better to answer the question of ‘what the customer wants’ than customers themselves.

There was overwhelming positive response for the VoC from the community, as we pioneered this process in the airport sector. As part of our endeavour to strive for better service and make Hyderabad a world-class airport and the logistics hub of India and the region, we frequently commission surveys to find out what needs to be done to make and keep us ‘world class’.

During the VoC process and the surveys, we received clear feedback that there is a need for a robust pharma handling infrastructure in Hyderabad. Hence, we decided to move ahead and make the investments. Keeping in mind the huge potential and the strategic location of positioning Hyderabad as a hub, we are in detailed discussions with a number of prime carriers and integrators to further boost both domestic and international connectivity to all parts of the world.

How can GMR’s exper se be leveraged at this pharma zone?

GMR as a group is into airports, highways, urban infrastructure and energy projects. We have a track record of successfully creating several infrastructure projects within India over the last few years. Having proved as a leading infrastructure company in India, GMR has already started expanding its operations globally with power generation projects in countries like Nepal, UK, Philippines, Australia, Mexico, Singapore and airport development projects & operations at Istanbul & Maldives.

With such a vast experience in infrastructure creation, we are confident that we will be successful in this endeavour as well. We are also closely working with the pharmaceutical regulatory authorities to ensure that our facility is in compliance with the global industry standards.

February 2011 I Modern Pharmaceuticals

Who are the other partners in this venture with regard to IT, logis cs, data management, etc?

Our operations are supported by stateof-the-art IT management system ‘HERMES’. Hermes fully complements the trade requirements and enables real-time warehouse & data capture. In order to improve the road connectivity to the terminal, RGIA has entered into an agreement with TCI for creating a schedule with dedicated trucking network for the terminal. TCI has the capability to operate reefer trucks. And we are confident that the Road Feeder Service (RFS) network will support the pharma zone and, in turn, the trade, enabling comprehensive temperaturecontrolled supply chain logistics solutions.

The pharma zone and other cold storage units in the terminal are equipped with data loggers for temperature recording and display. Temperature maintained at any point pertaining to any date can be provided to customers.

Air freights are expected to face higher demand marred by over-capacity and weaker margins.

How will you cope with this?

Our experience at Hyderabad is quite positive with the robust growth recorded and we envisage that in the coming years, we are looking at increased capacities on both domestic and international routes.

Working towards this direction, we are consistently in touch with our airlines partners to enhance capacity, especially with wide-body, main deck lift for Hyderabad.

How well-equipped is the newly developed pharma zone to handle temperature-controlled goods?

The air cargo industry is facing several issues while providing logistics for the pharma industry. Additional capacities at competitive rates will further boost the industry and exports. Proper knowledge of handling sensitive products like pharmaceuticals is a must for all stakeholders, right from the supply chain solution providers to airport custodians & operators to the CHA’s & the airlines.

Unorganised players risk contaminating the products and jeopardising the business by unsafe supply chain methods, only few service providers are organised who provide temperature-controlled solutions from origin till destination port.

We assure complete temperaturecontrolled storage and handling at our terminal with real-time data capture and security surveillance. Our initiative of creating a pharma zone at our terminal would stand as a benchmark for others within the country and abroad to follow suit.

What have been your investments in the technology expansion/ upgrada on in the cold chain area like in the past two years?

In 2009, after cautiously observing the pharmaceutical export trend, we expanded our cold storage facilities in both export and import warehouses. We have ‘doubled the capacity in exports and tripled in imports’. However, in 2010, due to rapid rise in export, especially of temperaturecontrolled products, we felt the need to further enhance the capacity of our facility.

The ‘Pharma Zone’ at Hyderabad is right up on the map, now being the first on-airport based dedicated temperature-controlled facility for storage and handling of pharmaceuticals. There is a need to ensure that ‘no short cuts’ are taken in the supply chain by careless or unscrupulous operators putting precious life-saving drugs at risk, which other than causing serious harm to consumers, can lead to cancellation of orders and, more importantly, damage the hard earned reputation of our pharma industry and the country as well. Hence, we are closely working with Drug Control Authorities and other relevant agencies to ensure that not only our Pharma Zone facility is world-class and complies with the highest world standards and regulatory requirements, but also ‘integrity’ of the entire supply chain from ‘manufacturing to end-user’ is maintained at all times.

This will give peace of mind to the pharma industry, stakeholders and end users alike.

Only then will it be a truly ‘world-class benchmark’ for all to follow. MPh (arshia.khan@infomedia18.in)

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Case Study

Importance of a pharma zone

Quality on priority Hyderabad is a pharma-driven industry and an emerging market in pharma manufacturing and exports.The exports have increased by 21 per cent in 2010 compared to that in 2009. This necessicates the use of the temperature controlled zone, to ensure the safety of medicines. A look at the recently inaugurated Hyderabad Menzies Air Cargo Pvt Ltd. result in huge financial loss to the exporters.

Pharmaceu cal air exports

W

ith growing demand for export of pharma products in India, varying climatic conditions, the supply chain and stringent regulatory demands on pharma products handling, temperaturecontrolled handling is a must for pharma products throughout the supply chain.

Pharmaceuticals are life-saving products of high value. Improper handling of such consignments can pose risk from point of view of commercial medication and rejections at the destination. This will

Paul Smith CEO, Hyderabad Menzies Air Cargo Pvt Ltd & Menzies Bobba Ground Handling Services Ltd

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Bottlenecks in terms of temperature-controlled handling at any point of the supply chain process can result in risks to product efficacy.

The challenges faced by pharma companies in such a scenario include lack of temperature-controlled storage facilities at airports, lack of quality practices followed by the handling and transporting agents, frequent offloads of airfreight by carriers due to excess passenger loads and lack of proper infrastructure at different channels of supply chain like freight forwarders, wholesale distributors, retail companies and pharmacies. There also could be contamination of pharma products due to lack of quality practices followed during supply chain and insufficiency of temperature-controlled vehicles while distributing large scale of air freight.

Further, the inability of the exporters to afford temperature-controlled ULDs offered by the carriers because of high freight rates makes distribution of the product into countries with extreme temperature conditions a big challenge due to which at times even the highly sophisticated infrastructure may also fail to maintain the quality of the product.

At Hyderabad, 70 per cent of the total exports constitute pharma products. Of this percentage, currently, the company

has been instructed by the shipper/freight forwarder to store only 12 per cent of the pharma consignments under temperature control. But, in addition to the above volumes, more percentage of pharma products that are currently being booked as general cargo can be brought under temperature-controlled handling.

Export trends in 2010 At Hyderabad, pharma products exports have increased by 21 per cent in 2010 compared to that in 2009. In 2009, pharma exports registered a 15 per cent growth compared to that in 2008, despite the entire air cargo industry facing economic slowdown in that period. Considering imports, that of pharma products grew by a record 31 per cent in 2010 compared to that in 2009. The company handled about 23,000 tonne of pharma products (both exports and imports) in 2010, which constitute 53 per cent of the total international air cargo market at Hyderabad. About 50 freight forwarders are dealing with pharma logistics and the products are being exported to about 150 destinations.

However, pharma logistics in India still lags behind as compared to many developed and developing countries. India ranked 47 in the Logistics Performance Index conducted last year. Pharma companies depend on Third Party Logistics (3PLs) for the supply chain. Many of the local logistics providers lack knowledge of the handling and storage practices to be followed for pharma products. Poor infrastructure and handling practices at airports/seaports, poor road network, etc are some of the major bottlenecks in the Indian logistics sector.

Modern Pharmaceuticals I February 2011

Case Study Supply chain of pharma air exports Transport from factory to origin airport

Storage & handling at exporters factory

Storage & handling at transit port

Transport from transit port to des na on airport

Manufacturers should strictly follow good storage and handling practices and insist that the 3PLs ensure that the same logistics standards are maintained while transporting their products.

Developments at Menzies In 2009, after cautious observation of the pharma export trend, the company has expanded its cold storage facilities in export warehouse. But in 2010 the facility turned out to be inadequate due to a sudden rapid rise in the export of temperaturecontrolled products. During this period, some percentage of cargo was noted to be diverted to other gateway ports. Thus, the project was initiated in April 2010, and the facility was officially launched on December 2, 2010. ‘Export Pharma Zone’ at Hyderabad is the first airport-based dedicated temperature-controlled facility for storage and handling of pharma products. Simply creating a facility will not completely meet the trade demands, unless good storage and handling practices are followed. Hence, the company is closely working with drug control authorities to transform the facility in compliance with all industry standards and regulatory requirements.

Pharma zone at Hyderabad air cargo terminal This is the first airport-based dedicated temperature-controlled pharma products handling facility in India. It consists of chambers with temperature in ranges of 15-25°C and 2-8°C, both in non-bonded and bonded areas, respectively. The facility is built for the purpose of handling export and transit cargo, with an annual handling capacity of 30,000 tonne. It is built over an area of 1,400 sq m, with a one-time holding February 2011 I Modern Pharmaceuticals

Storage & handling at origin airport

Storage & handling at des na on port

Transport from origin to transit airport

Transport form des na on port to consignee factory

capacity of up to 200 tonne depending on the density of the cargo. It is designed to safely handle only pharmaceuticals-related time- & temperature-sensitive products such as bulk drugs, formulations, APIs, raw materials, medicines and vaccines.

Hyderabad Menzies Air Cargo Pvt Ltd (HMACPL) pharma zone will be a key contributor to the supply chain of pharma cargo originating at (or) transiting through Hyderabad air cargo terminal. The pharma zone is one of its kind to handle pharma products, with five dedicated truck docks with automated doors, FDA approved data loggers to record temperature and humidity, specialised equipment, and X-ray machines, 24/7 Closed Circuit Television (CCTV) surveillance, SMS, email alerts and audible alarm fitted to the data logging system to track any excursions in temperature and humidity, trained employees, uninterrupted power supply, emergency response and risk assessment in place, work space for regulatory authorities, etc.

However, many of the exporters still move their pharma products consignments meant for international export on normal trucks from their factory to the terminal at HMACPL, and declare the consignments as general cargo despite temperature remarks mentioned on the packages and adequate temperature-controlled facility available at the terminal. This might be due to shortage of reefer trucks, lack of awareness among the exporters about the facility or due to cost advantage. World wide implementation of Chapter 17 rules introduced by the International Air Transport Association (IATA) governing the transport of temperature-sensitive healthcare products and complete awareness among the trade

Storage & handling at consignee factory

about the facilities at airports will definitely arrest these practices. We have initiated the programme of creating awareness among the customers about this facility and request them to use it for quality handling of pharma products. This facility will support the terminal in arresting cargo diversion and retaining the volumes. Once customers start using this facility to the extent of 100 per cent, this model can be replicated in imports as well.

Prospects Other major markets for pharma products exports in India are Mumbai, Bangalore, Chennai and Ahmedabad.

Creation of a pharma zone facility is required at these ports also, as they handle significant volumes of pharma business.

Drug control authorities have already suggested for creation of dedicated Pharma Zones at airport & seaports complying Good Storage Practices. They have also suggested creating a facility inside the terminals with a dedicated area earmarked for performing sampling. In the near future, all Indian ports will be facilitated with Pharma Zones and it is a matter of pride for Hyderabad to be the first port to accomplish this.

More to go...

Moving forward, HMACPL plans to enhance the cold storage facility in imports, as the temperature-controlled volumes have considerably increased compared to those in 2009. Also, the company is working on to increase the storage capacity of the import warehouse by providing additional racking systems and making structural modifications. MPh (paul.smith@hyderabadmenzies.com)

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In Perspective

Cold chain infrastructure

At the nucleus of pharma supply chain The adage ‘preven on is be er than cure’ is now well known to the Indian popula on and hence the use of vaccina on is increased over a period of me. However, these vaccines need to be kept under the desired temperature, which con nues to remain a challenge. A view of sanofi’s strategies in place.

‘Sangama’- Management Committee addressing via webcast

T

he business model for logistics has evolved over the last 50 years, moving from a single national service provider to the owned depot concept, to Carrying and Forwarding Agents (CFAs) and consignee agents. It is now moving towards a more logistics-driven approach, ie, how fast one can provide services. With the Goods and Service Tax (GST) soon coming into force, and therefore no tax on inter-state movement, the single differentiating

factor will be customer service and prompt delivery of goods.

The evolution is also at the level of service providers who are now upgrading their services as well, for example, in earlier days there was no way to track consignments, cold storage vehicles, etc, whereas now both online and General Packet Radio Service (GPRS) systems can be used for this purpose.

Logistics and distribution is not a core competency of pharma companies, as their focus and efforts are directed towards bringing healthcare solutions to patients. Hence, a trend towards outsourcing of this service to a third party service provider is seen.

Business model for logis cs by sanofi-aven s Shirish Ghoge Senior Director - Supply Chain, Institutional Business & Public Affairs, sanofi-aventis Group - India

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Supplies of pharma products through conventional channels: Customs Warehouse (CWH) CFAs Distributors Retailers

Supplies of Vaccines: CWH CFAs Distributors Doctors sanofi-aventis relies heavily on its relationship with its distributors and CFAs who it considers not just as a trader group but as its strategic business partners. The company recently organised ‘Sangama’ – the first-ever nation-wide webcast meeting for distributors/CFAs – where its management committee shared the company’s vision, growth strategy and plans with over 600 attendees.

Each distribution channel has its own advantages and disadvantages. The conventional model of distribution is effective not only in urban and class A markets but also in interior markets, ensuring that medicines are made available to all patients. However, there also exists the risk of drugs expiry and their return to the manufacturer for proper ‘destruction’ treatment.

Evaluating the distribution model of vaccines, it is found more service oriented and specifically focussed on the doctor’s demands, as vaccination in India is conducted by doctors in their own clinics/nursing homes/hospitals.

The vaccine market is growing at a much faster pace than the pharma market, which means that people now have better awareness about diseases that can be prevented through vaccination.

This creates a bigger challenge for the distribution channel, where a small quantity has to be made available at a short notice. The advantage of this model is that customers get vaccines through their doctors and the possibility of getting a spurious product is remote.

Modern Pharmaceuticals I February 2011

In Perspective Its major disadvantage is that it is difficult to get authenticated data on vaccine use.

Another benefit of the CFA system is that it is relatively cost-effective, with the distribution-to-sales-cost ratio for pharmaceuticals being 2.5-3 per cent.

Also, the company has a greater control over commercial conditions. Problems mainly arise when a service provider is not aligned to the company’s policies and compliance regulations.

Tackling the challenges The major issue that the pharma industry is currently facing is power shortage in most parts of the country, except class A cities. This adversely impacts the cold chain, which is essential for retaining the efficacy of medicines/vaccines.

The cost of infrastructure in terms of warehousing/cold chain is substantial and has resulted in elements of the cold chain equipment not being run, thus affecting the efficacy of medicines/ vaccines. sanofi reinforces this in all

February 2011 I Modern Pharmaceuticals

its communications to Pharma Vaccines distributors/CFAs. Many of its distributors are also CWH CWH becoming sensitised on the importance of the same and Carrying and Carrying and have requested for training forwarding agents forwarding agents sessions. But, more people need to understand the Distributors Distributors storage requirements.

In rural areas, an additional challenge is Retailers Doctors poor infrastructure. There is a great need for various groups/companies in the distribution are near expiry. Hence, they can be space to come together and work helped with tools for the same. towards addressing this challenge, and sanofi-aventis is also exploring the use of thereby reduce the overdependence on e-tools for greater company–distributor civic authorities for the same. interface with features to help address With increasing number of products these needs. and retailers across geographies, there is Information sharing is another also an increase in the incidence of expiry. important concern. It is imperative Unfortunately, there is no information for partners to align with the needs flow, and thus limited visibility of stocks of today’s data-driven industry for is available at the retail level. It is often efficiency in processes and transparency difficult for distributors/CFAs to know in operations. MPh whether and which of their stocks (www.sanofi-aventis.in, www.aventispharma.com)

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In Dialogue

‘The investment for the past three years on SCM was about ` 500 crore’ …says Alok Ghosh, President, Technical Opera ons, Lupin Ltd. He discusses the Supply Chain Management (SCM) prac se adopted by Lupin, and the investments made in SCM.

Please state the investment & revenue made by Lupin in SCM. In FY 2009-2010, Lupin’s sales revenue was about ` 4,800 crore. The investment for the past three years on SCM was about ` 500 crore.

Kindly explain the company’s distribu on strategy.

We have tied up with DGN Technologies for distribution of our products in 62

Sales (net) growth 17%

` million

Lupin Ltd follows the SAP system, which provides assistance right from inventory control to the production and planning stage. Presently, many pharma companies are opting for this system, as it allows efficient and timely delivery of the final product. Also, the SCM has now become quite convenient, as the products can easily be tracked and recorded. With regard to requirements, we decide on the mode of transportation. Usually, the time taken to transport the goods via sea takes three months, but in case of an emergency, this can also be done within two months. Some of the major markets that we cater to are the US, Australia and Europe. We have to operate within the specified time limit, or else the buyer might shift to another company. Thus, stocks need to be maintained for the supply chain to remain intact right from the procurement stage to the dispatch of goods.

Lupin’s performance in Q3 2010

What are the key challenges that Lupin faces in SCM? Lupin faces considerable challenges in managing the supply chain. For example, if a company is unable to supply the products to its end-user and seeks help from us, we undertake the entire responsibility to supply the product on behalf of that company.

We also try to maintain timely delivery of the goods in 90 per cent of the cases.

SCM should be extremely strong and devoid of any flaws. At Lupin, we ensure that problems do not crop up in the supply chain, as we function on SAP and cannot manually operate it.

What is the status quo of pharma companies with regard to SCM? The Indian pharma companies today cater exclusively to the domestic market.

While some domestic companies like Aurobindo pharmaceuticals cater only to the global market, Lupin serves the domestic as well as the international market. We have designed our production facilities according to both markets, and this helps us ensure a well managed supply chain.

Currently, the US is the fastest growing market for our products

17,500 14,000 10,500 7,000 3,000

12,554

14,672

Q3 09-10 Q3 10-11 Year

EBIDTA growth 15% ` million

What are the procedures that Lupin follows for SCM?

Europe. While in the US, we too have a distribution company (generic and branded) for this purpose. The distribution company stores our products in the storehouse and supplies these to the end-user as per instructions.

3,500 2,800 2,100 1,400 700

2,619

3,007

Q3 09-10 Q3 10-11 Year

Net profit growth 39% ` million

Meghna Mukherjee

3,000 2,000 1,000

2,240 1,606 Q3 09-10 Q3 10-11 Year

(generic and branded). Also, one of our biggest suppliers in the US is Wal-Mart. Today, we are rated as number 5 among the generic manufacturers. MPh (meghna.mukherjee@infomedia18.in)

Modern Pharmaceuticals I February 2011

In Dialogue

‘In India with its varied clima c temperatures, cold chain management poses major challenge’ …says Hitesh Patel, Senior Manager, Quality Assurance, Intas Biopharmaceu cals Ltd. He shares the SCM scenario at Lupin, as he highlights challenges, business model as well as future plans at Intas.

Meghna Mukherjee Please elaborate on the SCM in your company.

The manufactured products from a factory initially pass through the Intas Biopharmaceuticals Ltd (IBPL) - an owned central warehouse, and then reach the Carrying and Forwarding Agents (CFAs). These CFAs are primarily responsible for storing the company’s products and forwarding on request to the super stockist, substockists or hospitals.

The IBPL products, due to their nature and treatment application, are not available in retail shops. In the international market, these products are supplied either through the company’s own subsidiaries or its various business partners. Good warehousing and distribution practices require storage areas where medicines can be kept within acceptable temperature limits.

These products are monitored and checked by the agents as well. Hence, storage and distribution of these products need specialised care not only at the factory, but throughout the SCM until these reach the end-consumer.

List some of the biggest challenges in SCM faced by IBPL, and how it has countered them?

The major challenge that IBPL faces is that of delivering the product to the endcustomer at the right time, right place, in a secure mode and at a competitive operational cost with the right quality.

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IBPL’s products (proteinaceous materials) are temperature-sensitive, and to ensure sound quality, are stored under specified temperature condition (2-8°C) during storage as well as transportation, till these reach the end-user. The products can also be transported in the temperature range of 2-15°C [as per Parenteral Drug Association (PDA) technical report, provided the product stability supports these].

Proteinaceous materials are sensitive to extreme (very low and very high) temperatures as compared to specified storage temperature. For example, on exposure to extremely low temperature (freezing), for even a brief period at sub-zero temperatures or to a very high temperature, these protein materials may get irreversibly denatured. This would thus result in a loss or diminishing of efficacy or make the protein ineffective, thus preventing the product from delivering its promise.

As per the Indian regulations, manufacturers produce medicines by practising high standards of Good Manufacturing Practices (GMP) during manufacturing and ensure strict quality assurance requirements for the finished product.

But as soon as a manufacturer releases the finished product for distribution in the market, the agents involved in the supply chain activity ignore the fact that medicines need to be treated carefully. This is especially observed in the area of transport arrangement and at various storage/staging locations

where clearance formalities are required for further dispatch. Apart from this, it is a task for a company if its product is recalled because of the highly fragmented nature of its distribution network. This necessitates a foolproof system in place. In case of recall, today, a manufacturer can trace its product batch up to the stockist or sub-stockist level, but it is difficult to trace it up to the retailer level, as there is no strict control observed in selling drug and keeping appropriate record for reconciling the receipt and sale by retailers. Thus, for the benefit of the public, we suggest that Indian drug authorities should extend a strict control over retail business of medicines and force all those concerned to use technologies such as Radio Frequency Identification Device (RFID) for tracking products along the entire supply chain. This would also ensure that counterfeit drugs do not enter the system.

What measures does the company follow for improving SCM? In a country like India with varied climatic temperatures, cold chain management poses major challenges.

Keeping these factors in view, IBPL has designed and developed a system to ensure that the required condition of the product, which is stored in qualified cold storages at the manufacturing plant and premises of CFAs. Intas has invested considerably in enhancing its SCM. IBPL keeps a temperature data logger in the cold Modern Pharmaceuticals I February 2011

In Dialogue storages to monitor their temperature.

Cold chain temperature of the product consignment in transit is also monitored using the data logger or by affixing special temperature indicators on it. Quality Assurance (QA) also has a procedure in place for implementing a corrective action in case of adverse events.

The QA has trained all its CFAs to follow good warehousing and distribution practices.

technology, regulations, capital and market competition.

India is a geographically diverse country, with extreme climates that make distribution a critical function.

The long channel of distribution and high incidence of brand substitution make it mandatory for a company to ensure that all its products are available at all distribution locations at all levels and at all times.

Who are your channel partners?

Please elaborate on the contemporary logis cs scenario in the country with respect to pharma industry.

Every company has its own business model, which is based on the type of the products it offers. Pharma companies in general design their models according to specific therapeutic areas to target, and on the basis of their strength in the market.

Companies keep changing their business model along with changes in

66

One of our chief and crucial partners in the SCM is Kanchan Pharma, Ahmedabad, which is our central warehouse storage facility. Among others are Blue Dart, World Courier and Om logistics, which help transport our products to different locations.

Briey describe IBPL’s distribu on strategy and its turnover.

Based on the business forecast and the market demand, products are manufactured at the plant and

then released by the QA department after thorough examination. The products are distributed in the market as per the system explained in the procedure of SCM. The annual sales turnover of IBPL goes up to ` 100 crore.

Highlight some of the recent developments at the company.

IBPL, which has already invested over ` 100 crore at its facility, plans to pump in additional ` 150 crore over the next 4-5 years. The company’s current marketshare is about 10-12 per cent in India. After having established its presence in India and other semi-regulated markets, the company is now focussing on developing biosimilars and bio-better products for the regulated markets of Europe and the US. With an R&D focus on oncology, the company also provides contract research and manufacturing services. MPh (meghna.mukherjee@infomedia18.in)

Modern Pharmaceuticals I February 2011

In Dialogue

‘Awareness should be created among people right at the grassroots level’ …says Dr Prosanto Chowdhury, Medical Officer, Cordlife Sciences India Pvt Ltd. While he discusses the promises that stem cell based treatment offers, he underlines the cri cality of a sound supply chain to secure the cord blood samples from being exposed to any form of radia ons.

Dr Asma Mohd Yousuf What are the growth drivers for the biotech segment?

The growth of the stem cell market is mainly driven by the demand from people for treatments of various diseases. Today, the market has several effective antibiotics that have well taken care of the infections.

However, lifestyle diseases and genetic disorders are yet to be cured.

Today, due to changing lifestyles and availability of improved diagnostic procedures, many diseases are diagnosed at an early stage. Thus, the disease burden keeps increasing and is responsible for increased morbidity as well as mortality.

Stem cell transplants offer curative solutions to many ailments. There have been around 20,000 stem cell transplants that have been successfully carried worldwide.

How did your company perform last year and what are your targets for this year?

The growth recorded for the last financial year was 300 per cent. We are in the upward phase of the curve right now and plan to attain at least 300 per cent growth even this year.

What are the challenges faced by your company and how do you plan to tackle them?

Nowadays, people are aware of the diseases and their consequences. They spend money on health insurances. With the technological advancements, today, it is possible to cure diseases for which biological insurance is 68

required. Therefore, awareness should be created among people right at the grassroots level on how crucial it is to invest in this segment as well.

Further, doctors and customers should be educated and informed that the results of stem cell therapy are genuine. Besides, it is essential to have specific scientificoriented projects to understand the role of stem cell therapy in patients with different medical conditions.

Moreover, client information and their education as well as creating awareness are an essential component of our business model.

36 hours so that it is viable for use. Hence, we have tied up with Jet Airways so that the samples reach us as desired. Often, for conducting certain tests that are not done in Kolkata, the samples have to be sent across to other cities in India or even to Singapore. As the samples are thermolabile, the temperature has to be maintained at -60°C. For this, the samples are transported in solid carbon dioxide. All these factors have to be taken care of and even the partners helping in transportation must be trained so that nothing goes wrong at any point. We have associated with DHL for the export of our company’s products.

How do you plan to tap the market, global as well as Indian?

How do you see the growth of logis cs market in India?

The organisation is focussing only on stem cell therapy. We have tie-ups with institutions abroad for various stem cell trials. In Singapore, we are working on the effect of stem cells on various skin conditions, eg, after trauma or burn. In Europe, studies are carried out on diabetic people. In Australia, neural and T-cell expansion is the core area focussed on.

While in the US, the advantages of stem cells in heart-related disorders are also studied. After weighing the cost-benefit ratios, we plan to introduce these therapies in India as well.

Nowadays, tissues are also developed using cord blood cells. This will further help in bringing solutions to many health problems.

Thus, the demand will further rise, and, in turn, raise the demand for easier and better supply facilities.

How crucial is SCM to ensure that safety and efficacy of products?

What steps has the company taken for the same?

When it comes to dealing with stem cells, it is essential that the raw materials be intact.

Cord blood is collected in various states in India and has to reach the centre within

What are CordLife Science India’s future plans?

We are planning to partner with the well performing hospitals all over India. We also plan to form partnerships with government hospitals, as they are a major source of patients. Our focus is not just on India but other countries as well.

We are already present in tier I cities in India. We are currently present in tier II cities in the East and North East India and some other states, and plan to expand to all tier II cities across India as well. MPh (asma.yousuf@infomedia18.in)

Modern Pharmaceuticals I February 2011

Business Strategy

Pharma supply chain strategy

Say no to ‘one-size-fits-all’ model A proper tax structure, me culous planning and a customised approach will be an effec ve manner to outdo the bo lenecks in the pharma supply chain. An analysis.

T

he pharma supply chain is inherently different in its organisation and composition compared to other industries.

The major difference is that for the pharma business, the pricing for each end-user is different. Therefore, a hospital purchases drugs at lower rates than a retail pharmacy. There are programmes like Medicare and Medicaid and other insurance programmes where procurement prices are different from what they are for a customer purchasing at a retail outlet. These nuances give a cmpletely different angle to Supply Chain Management (SCM). The pharma industry is under

Hitesh Gajaria Executive Director, KPMG India

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severe pressure with increasing R&D costs, growing development timelines, increasing payer pushback and a more knowledgeable customer. The industry is responding by cutting down on development time, stopping projects that do not seem promising at the right time and increasing efficiency by outsourcing non-core activities.

Therefore an effective SCM is a concern, as the consequences of a faulty start in launching new products may lead to loss in revenue, sale and marketshare, may also result in high cost of logistics, high cost for expired drugs, excess inventory at various points in the supply chain excess expiry and unliquidated pipeline inventory.

Growth prospects An ideal situation would be to move from a ‘one-size-fits-all’ model to a more customised approach, considering that the wellness industry can actually not be compared to other industries.

An important requisite for efficient SCM is flexibility and responsiveness along with the reliability in shifting the supply process from a stock-based model to an order-based approach.

However, there are a few challenges like managing products in different stages of lifecycle, especially with multiple product launches, keeping supply chain flexible to align with changes in demand for new drugs, promotions and disease epidemics, maintaining efficiency in growing supply, manufacturing and

subcontractor base and reaching out to new domestic and international markets efficiently while still maintaining quality.

There may be a few drawbacks. Example: An identical supply chain footprint and policies irrespective of products lifecycle stages (especially of relevance in pharma due to the increased time in development of products), non-flexible manufacturing and sourcing facilities and capacities, unexplored alternative sourcing options and drawbacks in distribution networks.

Importance of ‘Strategic sourcing’ in SCM In order to maintain a competitive edge, it is important that the sourcing strategy has a distinct competitive advantage.

The key requirements are: Arriving at the total cost of ownership for products and channels, fixing the right demand flex fence for delivery of products in changing market conditions, pin pointing the sources of risks in supply & contract manufacturing base and their resolution.

Government support and tax implica ons The pharma sector has been grappling for some time now with issues like accumulation of CENVAT credit, difficulty in obtaining refund from the government, etc. The impact of these issues has indirectly passed on to the end customer, who has to pay more for essential medicines. Central Sales Tax (CST)/Value Added Tax (VAT) on sale of goods, service tax on services and levies such as entry tax, octroi, (imposed by state or local bodies) are some of the various hurdles in the path of efficient SCM. The government provided an exemption to pre-packaged goods Modern Pharmaceuticals I February 2011

Business Strategy (including pharma products) meant for retail sale, wherein the retail sale price has to be declared on the package. It is expected that the government may extend this exemption to all pharma products (even those that are not meant for retail sale and the retail sale price is not declared on the package), as it would benefit the end-customer in availing medicines at lower costs.

Special Addi onal Duty Most pharma companies are involved in the import and subsequent re-sale of unpackaged pharma products. The import of these products involves a duty element termed as Special Additional Duty (SAD) (in addition to the basic customs duty and countervailing duty). The SAD paid on imports is available as a refund to the pharma trader, provided it is proved that state level VAT is paid on the subsequent sales of the imported pharma products. The process of obtaining refund of SAD is extremely cumbersome and time consuming for both the Customs Department and the importers, which thus significantly increases the transaction cost.

Therefore, a key focus for pharma companies on the global level needs to be effectively aligning tax strategies with the supply chain restructuring initiatives by implementing Tax Efficient SCM (TESCM).

GST to beneďŹ t pharma industry The Finance Minister of India has announced the intention of the government to introduce Goods and Services Tax (GST) from April 1, 2011. However, given the current political compulsions, the rollout of GST is likely to be delayed. GST, if implemented in line with the recommendations of the task force set up by the 13th Finance Commission is likely to resolve most of the issues like multiple taxes for different parts of the supply chain in light of the increasing compliance burden. The supply chain is highly fragmented due to state/ municipal body level taxes. Unavoidable transportation delays due to check posts at state and city borders are some of the issues that challenge efficient functioning of the supply chain in India.

The way forward The future trends suggest a longer and more complex supply chain driven by greater product variety and faster change in assortments. The need of the hour is for supply chain strategists to locate their DCs and logistics hubs correctly, ensure timely information, cash flow and a flexible supply chain organisation, which is also collaborative with other business functions and trading partners. It is also imperative that strategists steer clear of supply chain bottlenecks like the absence of cold chains, poor storage facilities and transportation methods, and must ensure that an efficient information technology is in place for both front-end and back-end functions. Also, with trends like third party logistics making the chain longer and more complex, it is essential to ensure flexibility at every stage. MPh (hgajaria@kpmg.com)

February 2011 I Modern Pharmaceuticals

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People Matters

Training and educa on

The need for ethical consciousness Simply pu ng together the resources to start a logis cs business in the pharma sector is not enough. India now needs a blend of relevant laws, an improved educa on system and the consciousness to really change the prevalent system.

O

n a national level, no formal education in colleges is imparted as far as pharma logistics is concerned. Thus, people in this profession do not have any specialised expertise. Today just having enough resources, a warehouse and few other things set the business on roll.

Again, warehouse management along with experience in other related matters is not covered in the syllabi of any college.

A thorough reading of the current syllabus followed can show that it is outdated by almost 15-20 years.

Today, the syllabus for education is a major concern with regard to pharma education. By the time the government revises the syllabus, the demand changes.

Pravin Manker Pharmaceutical Consultant

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Thus, organisations like Indian Pharmaceutical Association (IPA), Indian Pharmaceutical Manufacturers Association (IPMA) and Indian Drug Manufacturers’ Association (IDMA) should take initiatives to come up with institutes that would impart education to students in this regard.

Therefore, colleges should collaborate with management schools in this endeavour. For instance, in Bombay College of Pharmacy, all teachers are professional experts and not professors.

The college has a two-year curriculum, where the first year focusses on general courses and the second year has courses on specialisations like marketing or production. This has helped the college to attract good placements and the students also perform well in the professional field.

On-job training At the job level, when students are recruited in a pharma company, they are just given the basic training but no follow-up trainings.

Thus, students are directly put into the job cauldron. They are assigned work under a senior who provides guidance to them.

However, an oft forgotten fact is that the senior can be efficient in his profession but not necessarily a good teacher. Therefore, more often students are left on their own information consumption capacity.

In this way, there can be lapses in their comprehension of the subject.

All companies have a commercial outlook and are interested in the final

output. Pharma companies should hire consultants and trainers having expertise and knowledge of the real on-field job. There are facilities but the companies are reluctant to avail them.

The situation becomes all the more grim because the government also does not show active participation. In fact, in India, the success stories from any field narrate the achievements of either the private enterprises or individuals.

The low-down What is currently happening in the country is indeed sad. A regulatory authority ensures that the norms are abided with when the goods are in warehouse, but hardly any care is taken when the goods are in transit. After the customs operations are accomplished, there is no compliance with the conditions stipulated. Newspapers today are replete with news of crime, showing that it is the courts that seem to be practically functioning in the country and not the government. It is disappointing to see that the lawmakers are the ones who break the laws here. Thus, India should have a strict enforcement of judiciary.

Making a conscious eort However, beyond all this, what is required is an increase in the consciousness among individuals. An individual must be aware that he is dealing with life-saving commodities, and thus these products definitely deserve a special concern. Thus, it is the amalgamation of the attitude at the individual level and the external enforcement of the judiciary that can mark a change in the process that is prevalent at the moment. MPh (pmanker2005@gmail.com)

Modern Pharmaceuticals I February 2011

An invite that rewards as well...

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

You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 3000 words, while that of a product write-up should not exceed 200 words.

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

The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will receive a complimentary copy of that particular issue and an honorarium cheque.

Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors.

Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost.

So get going and rush your articles, write-ups, etc…

Thanking you, Yours sincerely,

Industry Update

According to a recent report by Mckinsey & Company, the Indian pharma market is poised to grow to $ 55 billion by 2010.

And, this will be realised through a host of factors. Here is a snapshot of some of the key sectors and the strategies being adopted to capitalise on the opportuni es to go global.

February 2011 I Modern Pharmaceuticals

75

Industry Update

APIs and excipients

Needs a stringent regulatory approach In the coming years, the Ac ve Pharmaceu cal Ingredients (APIs) and excipients market is expected to grow faster due to the demand of generics and biological drugs. And, India seems to be a lucra ve market for this growth, owing to its huge spend in the healthcare sector.

Anant Thakore Managing Director, AVIK Pharmaceutical Ltd

In India, as far as the raw materials, APIs, excipients are concerned, both manufacturing and importing go on a full swing. But to be more precise, import activities in this regard are more vital. Mostly, 60-70 per cent of our imports is from China. For example, our company is manufacturing hormones and steroids as bulk drugs and not as formulations. We are conducting business of bulk drugs, intermediates, the specialty chemicals. For this we have to rely on raw materials.

Pharma industry is growing at 15 per cent. Thus, catering to this

booming demand is mandatory.

Therefore, the competition that is prevalent is not an easy one. For any company to survive in this sector, studying of the demand pattern and the consequent availability along with the growth rate of the product is very important. Further, the technology that aids the process should also be of superior quality.

Like any other industry, there are several challenges in this sphere. In our country we are required to follow Schedule M guidelines.

But the customer demands are certainly different in this regard.

They desire the guidelines of WHO

GMP or any other international regulatory standards.

Therefore, in order to cater to this trend the costs usually tend to go up.

However, for the other players who are abiding by Schedule M, the cost is relatively low. Thus, the main challenge is to maintain the quality of the products and offer them within a certain cost bracket. In this way the competitive situation is created. To sum up, in order to be a competent player in this arena, there should be considerable focus on the exports but not compromising or neglecting the local market where the demand is also very high.

Bafna Mahaveer Chand Chairman and Managing Director, Bafna Pharmaceuticals Ltd

The recent rise in crude oil price has resulted in the increase in the cost of APIs. Multinational companies are focussing on India as it is a lucrative market for pharma ingredients due to its growing population and increasing expenditure in healthcare.

The turnover of Bafna Pharmaceuticals is about ` 200 crore. The company has emerged as the most competent player providing consistent and unmatched services to both domestic and international market. Equipped with a state-of-the-art Formulation 76

and Research & Development (FR&D) facility, the company is looking towards strategic partnerships and global research projects. Bafna Pharmaceuticals believes in moving ahead with time and has invested in R&D, setting up a dedicated FR&D wing, to provide new and improved finished pharma formulations while maintaining its economic viability, for the benefit of its clients.

The company has been consistent in advanced research and quality oriented processes, which have been instrumental in the manufacture and marketing of over 336 licensed pharma products and 73 registered products,

which it contract manufactures and supplies to leading domestic and international players. The current era is of an emerging and regulated market. In 2011-12, the company aims to expand its facilities to meet the growing demand. It aims to be recognised as a strategic leader in the global pharma value chain, through dedicated efforts towards quality management and contract research and maintaining economic viability too.

The company is targeting a turnover of ` 5,000 million by 2013, and is focussing on increased production and marketing of preferred prescription drugs in the global market.

Modern Pharmaceuticals I February 2011

Industry Update R K Thukral Executive Director, IOL Chemicals & Pharmaceuticals

API market sales revenue is expected to grow at a Compounded Annual Growth Rate (CAGR) of 5.9 per cent from 2010 to 2015. This growth will be driven by the rise in demand of generic sector drugs and biological drugs. Synthetic APIs continue to dominate the global revenues. However, the growth in biotech APIs is expected to be faster in the forecast period. The global market for excipients is projected to grow at a stable rate for the next several years. New blends and grades of existing excipients are providing innovative ways to enhance multi-functionality and performance of the products. For FY 2011, the company’s target is to achieve a turnover of ` 430 crore. The company plans to expand the sales of its generic API Ibuprofen to regulated markets, ie, the US and Europe.

Recently, the company has received COS certification from European Directorate for the Quality of Medicines (EDQM), Europe, for Ibuprofen. With this certification, it plans to diversify into IOL Chemicals and Pharmaceuticals

Ltd (IOLCP) by entering into a new therapeutic segment of Proton Pump Inhibitors (PPIs) by taking up implementation of projects to manufacture drugs, such as rabeprazole, omeprazole, pantoprazole, esomeprazole and lansoprazole, with an installed annual capacity of 150 TPA. Pricing one’s products competitively is intrinsic to most successful marketing strategies. The company offers very cost-competitive products. For FY 2011, IOLCP has undertaken the project for installation of manufacturing facilities of PPIs and expansion of existing manufacturing facilities with total project outlay of ` 130 crore. The project will be operational in FY 2012.

The increasing growth of the generic pharma industry is best reflected in the concomitant growth of merchant API manufacturing industry. Looking ahead, the worldwide market for merchant APIs is projected to grow at an average annual growth rate of 6.8 per cent through 2013 to about $ 50 billion. In this period, the growth of innovator APIs and generic API is expected to be about 1.8 per cent and 11.4 per cent, respectively.

Seshnath Chauhan Associate Director, API sourcing, Dr Reddy’s Laboratories Ltd

Though it cannot be generalised and is definitely case specific but usually for API the demand is more than supply. Like any other industry, in this arena also the relatively new players find it difficult to survive. First, they are required to firm their foothold in the space. However, though there is a relative improvement in the availability of APIs, the prices have definitely gone up. Due to the increase in the cost of manufacturing, the costs of inputs have also gone high. This has resulted in the 5-10 per cent rise in the price of the commodities.

Recently, Drugs Controller General of India (DCGI) has declared that it is going to start inspection of Europe and China based companies that are into API manufacturing. In India, if the companies are not WHO GMP certified, then the licences are not issued.

However, in China there are some companies that undertake the activities of API manufacturing though they have not received licences. Thus, in this situation, the inspection procedure will develop a scenario of challenge for us.

For any company to become a dominant player in this arena, it is

required to update and upgrade itself.

The company should be aware of the US Food and Drug Administration (USFDA) guidelines. It has to keep in mind that the expectations that were there two years before are not relevant any more. Therefore, there is a need to adapt and adopt to the changes. With time more and more drugs will go generic and this would create an opportunity for the API manufacturers as they will have to cater to the demand. In short, one can easily say that the next five years seems bright for this industry.

V Ravishankar Manager Quality Assurance, Anglo French Drugs & Industries Ltd

Inactive excipients typically constitute about 99 per cent of a finished drug.

These are derived from natural, chemical, biological and various other sources and can be used in manufacturing several products and diverse businesses such as pharma, food, cosmetics and general industrial products. Currently, February 2011 I Modern Pharmaceuticals

more legislation, guidance and documents are targeted mainly for compliance of APIs and finished products. The role of excipients in pharma products varies from non-critical to highly sophisticated formulation, depending on the drug and dosage form design. This sector is growing rapidly with the development of more innovative drug delivery systems.

Manufacturers and suppliers need to integrate the environmental impact

with the pharma industry in order to build a proper level of control into their manufacturing and distribution practices.

Greater and stringent regulatory demand for safe products, pressure on price from competition and low-priced sources of material of ‘questionable quality’ also need to be considered. It is essential that parameters such as traceability, change control, notification and contamination control are addressed.

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Industry Update

Pharma machinery

Requires a booster shot from the government The pharma machinery sector is picking up pace by expanding the product por olio and geaographical foot print. A helping hand from the government in terms of tax incen ves and SEZs will take it a long way.

Piyush Tripathi GM - Technical Sales, Chitra Pharma Machinery

Over the years, pharma machinery have successfully managed to fulfill the requirements of domestic and global clients. These constitute a fundamental part of both modern and traditional medicine manufacturing processes.

Average investment depends on various factors, one of which is the size of the company. Industrial returns depend on the scale of work done and the

client catered to, ie, the end-user or manufacturer.

Modern and advanced manufacturing relies on small-scale suppliers as their tool of supply, rather than investing in capital.

There are several obstacles in providing process-based solutions. For overcoming these, the basic mechanical system remains the same in any machinery designed, ie, a filling machine used to pack powder or liquid and developed to suit a particular bulk density of powdered or liquid material.

Raj K Menon Owner, Karishma International

With the increase in pharma exports, more machinery catering to this industry started coming up and with some protection from import duties and licences, companies manufacturing pharma machinery grew rapidly. Even then, these were only few in numbers, with Cadmach for Tablet, P+AM for capsules and Pharmalab for liquids being the major machine manufacturers.

Excise relief in certain zones, demand from export markets and competitive prices in international market are helping

the pharma machinery sector to grow rapidly. And, to cater to this constant demand, several foreign companies like Bosch, Fette and Glatt, have set up shop in the country, either on their own or through collaborations with Indian companies.

Thus, the increase in pharma formulation exports from India can be considered as the major growth driver for the machine sector.

There is hardly any R&D going on in the machinery sector.

Unfortunately, even today manufacturers here copy designs from foreign companies.

Jignesh M Panchal Partner, Karnavati Engineering Works

With the pharma industry gaining momentum, the market expanse of pharma machinery is also broadening.

In Gujarat, Special Economic Zones (SEZs) are being developed with an aim to cater to this growing demand.

With only two years in this space we are a relatively new company. But as the scope for this industry is increasing, in the next five years, we are sure to assume a greater 78

proportion in the pharma machinery space. Moreover, like in any business to prosper, a decent investment is necessary. Our company manufactures and develops stabilisers. And, different customers require stabilisers of different sizes. Quality is another important factor in this respect. Thus, one should constantly look into products manufactured by competitors to achieve a fair notion. Further, one must constantly follow the overseas players, Internet and consult engineers to get ideas from them.

Modern Pharmaceuticals I February 2011

Industry Update

CROs and CMOs

To collaborate and expand to global markets for growth A right partner to boost the industry/individual company’s growth seems to be the strategy adopted by CROs and CMOs. Dr Arun Bha President, ClinInvent

ClinInvent is a Clinical Research Organisation (CRO); hence, it does not have an R&D division. Its major clients are big pharma companies from the US and Europe and also biotechnology companies from the US. The company is currently facing several issues, some of which include the challenging regulatory environment, maintaining quality performance for new inexperienced sites, etc. In India, clinical studies are conducted mainly in two phases – phase

II and phase III. The growth opportunities for the company lie in expanding the market base, increasing the number of trials and gaining the interest of the western pharma and biotech companies in India. Some of the key drivers and strategies of the company include client satisfaction, global quality at a reasonable cost and well-trained & experienced manpower. Its future plans are to tap the Asia-Pacific market.

It is also planning to expand its services with technology partners who have Electronic Data Capture (EDC), enter into strategic alliances and make acquisitions outside India.

Dr Viral Shah Medical Director, Spectrum Clinical Research Pvt Ltd

Last year, Spectrum had invested about $ 25,000 in R&D and is targeting an expenditure of about $ 50,000 for this year. The company introduced products like vaccines, blood samples, insulin, nutritional products and pathology kits last year. This year too it plans to come up with more similar products. The company’s major clients include pharma companies and CROs from India, the US and Europe. It conducts phase I and

phase IV trials in India. Some of the key drivers of the company include maintaining the quality of products & services and reliability. It also faces issues related to cold chain management, pick-up & delivery timeline and services to remote locations. In the future, it plans to tap the markets of the Middle East, Russia and China. With regard to expansions, the company plans to introduce dedicated clinical research centres across the country and establish exclusive tie-ups with major hospitals, nursing homes and diagnostic centres for providing clinical research services.

Rajeev Vaid Sales Director, Vishal Pharma

Vishal Pharma is engaged in production of several formulations.

Last year, the company came up with tablets like anti-gastro tablets and capsules. In the coming years, it plans to expand its base and develop more antibiotics, aloe vera gel ointments & other ointments, face washes, injectables, etc.

February 2011 I Modern Pharmaceuticals

The company is actively working both on the domestic and global front. Globally, it caters to the Government of Maldives, Congo, and others. Currently, it is in the process of getting registered in the global market, which will help broaden its area. At present, the company is not facing any challenges in the Indian pharma space. And, it is constantly working towards maintaining good quality and boosting up its sales service.

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Industry Update

Pharmaceu cal educa on

Need for industry-academia collabora on There is an an urgent need to address the pharma educa on scenario in the country. This can be done by se ng up a University of Pharmaceu cals, and also collabora ng with foreign universi es and ins tutes. Hands on training is also a must to ďŹ ll the gap between learning and its applica on.

Dr Annie George Vice President - R&D, Actis Biologics Pvt Ltd

Pharma education in India should put the country at the forefront of advanced technology in terms of development and manufacturing of pharmaceutical ingredients. The country has progressed well in reverse engineering arena. But the development in the discovery of new molecules is still way behind many developed countries.

Here, both the government and the country’s private sector should make more efforts to bring in or develop new technologies.

India accounts for 21 per cent of the world’s burden of disease, with the life expectancy of an average Indian still low at 62 years of age. People in India are still largely prone to communicable diseases such as malaria, kala-azar, filariasis, dengue, tuberculosis and leprosy, and Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome (HIV/AIDS) are also not under control yet. One of the reasons for the same is lack of medical awareness. Although the government of India has initiated a number of programmes to educate

Some of the leading pharmacy colleges in India 82

people, these have not percolated to the grass-root level.

There is a need to start more pharmacy colleges in the public sector, and students trained there should be employed for making people in the lower strata aware of the importance of medication.

According to a recent Confederation of Indian Industry (CII) study, the clinical research market is valued to be $ 1 billion. The world is watching the growth and performance of India in this business segment. There are positive signals and reports that justify the trends for pharmaceutical sponsors to consider India seriously for carrying forward their drug development initiatives.

Several multinationals like Pfizer, Aventis and GlaxoSmithkline (GSK) have already started their clinical trial shops in India either directly or through joint ventures.

In India, at present, the academia and industry do not have much interaction.

Both are working as two different entities and do not interact with each other. Indian pharma education system is mostly structured towards basic aspects without considering the industry needs. For this, Indian industry

should come forward and sponsor programmes in national institutes as per the requirement of industries. On the other hand, the Indian government should also start funding industrial projects in the industry. However, this is currently not happening in this country.

The government considers industries as profit making units and does not fund their projects. Thus, the government remains unaware of the needs and requirement of industries.

Most of the Indian companies cannot compete with multinationals in research with their limited resources. Also, most multinationals refrain from investing in India on the development of cutting-edge technology. In this area, Indian academia should collaborate with multinational companies and try to imbibe the latest technology from them.

In India, this kind of collaboration is currently seen in the defense sector. Besides, the pharma industry should also start similar programmes and equip themselves with the latest technology in the field of drug discovery. The Government of India should give full protection for such technology developed through patents and Intellectual Property (IP) laws.

National Institute of Pharmaceutical Education and Research, Mohali (NIPER), Mohali University Institute of Chemical Technology (UDCT), Mumbai Manipal College of Pharmaceutical Sciences (MCOPS), Manipal

Modern Pharmaceuticals I February 2011

Industry Update

Mangesh Joshi General Manager HR, Plethico Pharmaceuticals Ltd

There is immense scope and opportunity for Indian students in pharma education.

One of the emerging branches of pharma education is clinical Research and Development (R&D).

A number of clinical studies are underway in the western, developed countries. India is a hotspot for clinical studies due to its varied ethnicity and vast biodiversity of population. A huge number of super specialty hospitals have diagnostic tools with cutting-edge technology and state-of-art-facility, which attract many multinational companies to conduct their drug trials in India.

India has a well trained medical fraternity with a vast patient

population.

Considering the industrial need, a large number of well educated and trained human resource is required in pharma companies.

Most of the emerging opportunities today are in R&D. New drug discovery is not much developed in the country.

However, companies are looking for technically qualified people who are able to apply the science they have learned from universities and should be able to deliver the industry’s expectations.

Having said that, today, there is a huge gap in learning and its application. This gap must be filled through leveraging pharma education better than what it is now. At present, the candidates with B Pharm and/or M Pharm degrees are not employable directly in R&D and in clinical research area. They have to undergo industrial

training. At present, B Pharm students undergo a six-month training as part of their course. Increasing this duration will yield a better result.

Traditional courses will surely help attain academic knowledge, but only practical training will help students to put their academic knowledge into practice.

Today, several private institutes are tying up with foreign universities to start new courses in pharma education. These courses give more importance to practical knowledge.

These programmes will help students to get jobs easily and thereby aid the industry. Drug discovery is one area that finds it difficult to get the right candidate. It requires a huge investment and expertise. So, there is an urgent need for introducing new courses in this area.

Dr Ranjit Roy Chaudhury Chairman – Task Force for Research Apollo Hospitals Educational & Research Foundation (AHERF)

At present, in India, pharma education mainly consists of two courses – a Bachelor’s programme – B Pharm – and a Master’s programme – M Pharm.

Pharma production and R&D are taught in these courses.

Evidently, these are very well known courses across the country and the training given is quite good even by the most stringent of standards. However, this is not enough. Things can be made even better and promising. In general, pharma education can improve significantly if there is help from foreign universities, like in the form of partnerships or similar tie-ups.

These educational institutions will

bring expertise and improve the knowledge of students here.

This is important for India to become the global leader in the pharma industry.

The best way to achieve this is to establish pharmaceutical universities, which will improve the current situation of pharma education in the country. A pharmaceutical university will have its own set of rules and regulations, and it will enhance the quality of pharma education.

Medical universities, which were set up for healthcare education, have attained good results across the world. A University of Pharmaceutical Sciences is the need of the hour in India. There

The Maharaja Sayajirao University (MS University), Vadodara Kakatia University, Warangal Punjab University, Chandigarh

February 2011 I Modern Pharmaceuticals

are some plans to set up a pharmaceutical university in Delhi, and it is hoped that it will become a reality very soon.

The pharmacy colleges at Apollo Hospitals Educational & Research Foundation have a unit where pharmaceuticals production is taught.

One is a three-month programme and the other is a one-and-half-year course.

Students visit these units for practical training. One of the sections in pharma research also provides practical training to students in R&D. Such a practice is important today because clinical research is an important aspect of pharma education. Further, clinical trials form a major chunk of clinical research.

Banaras Hindu University (BHU), Benaras L M College of Pharmacy (LMCP), Ahmedabad Birla Institute of Technology & Science (BITS), Pilani Hamdard, New Delhi 83

Industry Update

Alterna ve medicine

Increase in demand in rural areas Aordability and eďŹƒcacy of herbal medicines, exorbitant costs of new allopathic drugs and high acceptance level of alterna ve medicines in rural markets, are boos ng the demand of this segment, which is further being driven by increased government support.

Akkshay Mehta MD, Mission Vivacare

Mission Vivacare grew its exports of nutraceuticals to approximately $ 20 million for the year ending June 20, 2010. And for the 12 months ending June 30, 2011, it is expecting to close with an export volume of approximately $ 30 million.

The company is pushing its growth in multiple ways, like by increasing its presence in multiple geographies. It expects to make the products available for sales in approximately 20 countries by June 30, 2011, which is currently about 10. The company is increasing its product range from the current 20 products to about 40 products this year. It is also working

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on sales through multiple distribution channels such as pharmacies, health food stores, doctors, online sales and call centre promotion.

For the year ending June 30, 2010, Mission Vivacare has been focussing on pushing forward its market presence, promotional activities, registration, launch activities, etc. It had completed its asset investment last year. This year, it is again focussing on launch and promotional activities.

Further, the company is concerntrating on business development with respect to geographies, number of products and distribution outlets, and also exploring forward and backward integration possibilities in the near future.

Modern Pharmaceuticals I February 2011

Industry Update Dr D B Anantha Narayana Eminent pharmacist (Retired Head – Herbals Research, Hindustan Unilever Ltd)

There is a growing shift in the attitude of the people as they now want to take charge of their health, so that they can protect and maintain their own lives. With the increasing burden of the lifestyle diseases, people are now opting for alternative medicines. Also hereditary diseases like hypertension, diabetes and migraine deserve attention from the root level as the severity of the diseases can be reduced with Ayurvedic medicines. Besides, the exorbitant costs of the new drugs and these getting banned after being released in the market have led to an increase in demand for

alternative medicines. Further, the cost of healthcare is different for varied strata of the society. There are several Primary Health Centres (PHCs) in our country that are not efficiently manned and do not have access to the basic drugs. In this scenario, alternative medicine suits the purpose best. Nowadays, most of the medical treatment depends upon the various diagnostic tests that indeed take too much of time. Thus, it is definitely wise to consider alternative medicine.

In this context, one should remember that this is not alternative medicine but actually the original form of medicine.

The market will definitely grow. People take these medicines as a supplement before or after lunch or also during

lunch. With time there is more emphasis on the Yoga as it helps to reduce the stress level of a person. In this regard, the number of ayurvedic doctors is also increasing as people slowly comprehend the significance of this form of medicine.

To be precise, pharma can only be applicable as far as emergency like cardiac arrest is concerned. To make the situation more favourable, the government is also extending support.

Another growth aspect is the role of the servicers. Though it is very loosely termed as ‘massages’, these exercises help in removing toxins from the body.

The organised centres are coming up with clean centres to facilitate the entire process.

Philipe Haydon CEO – Pharmaceuticals, Himalaya Drug Company

Himalaya products have found acceptance among doctors and serve the healthcare needs in over 70 countries.

Himalaya’s product portfolio comprises pharmaceuticals, personal care, baby care and animal health.

The growth drivers for the Ayurveda segment are as follows: Chronic and lifestyle-related disorders: Ayurveda is beneficial in controlling lifestyle-related disorders like diabetes, hypertension and obesity. In case of chronic health ailments that require long-term treatment, allopaths are open to prescribing well-researched and clinically proven herbal medications that will treat their patients better.

Ayurvedic medicines are now, more than ever, being prescribed along with conventional medicines to provide a holistic treatment.

Rural areas: Ayurveda has higher acceptance in rural areas because the practice of using herbs for medication and personal care needs is already prevalent in small towns/ villages across India. Traditional 86

healing system is deeply inculcated among the rural population of India.

Lower cost: With the rising cost of healthcare, herbal medicines are providing an affordable alternative, without compromising on their safety and efficacy.

Preventative care: People are becoming increasingly aware of healthcare issues, and therefore are seeking ways to keep disease at bay. The preliminary focus of Ayurveda is on preventative care.

Antioxidant-rich herbs, with natural immunity-enhancing properties, feature aplenty in Ayurveda.

Going natural: Recently, there has been a back-to-nature movement that is growing worldwide. People are choosing natural products for both their personal and healthcare needs.

They are looking for herbal products that are scientifically validated.

However, there is a large unorganised sector that thrives in the industry. To make Ayurveda at par with modern medicine, drugs need to be scientifically validated and companies like Himalaya have been working towards this endeavour in order to make Ayurveda mainstream.

The Department of Ayurveda,

Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) has been campaigning hard to strengthen the regulatory environment, and uphold a standardised protocol for all Ayurvedic products. AYUSH has also been working towards making clinical trials mandatory.

However, much more needs to be done to ensure that only well-researched, safe and effective Ayurvedic drugs reach the market.

Himalaya believes that no investment is too much when it comes to scientifically developed herbal healthcare products. Its R&D centre in Bengaluru encompasses an area of over 80,000 sq ft. The centre has a team of more than 100 multidisciplinary scientists. Himalaya has filed for 83 global patents, including patents for molecules for treating several lifestylerelated disorders and specialised skincare & haircare. In future, Himalaya plans to continue expanding its product portfolio in both therapeutic and personal care ranges. Research is being undertaken to find effective drugs for hepatitis B & C, cancer and depression.

With regard to its personal care range, the company is looking at new research areas like anti-ageing.

Modern Pharmaceuticals I February 2011

Industry Update

Biotech

Growing with speed India’s biotech sector is rapidly climbing the path of development, with its future appearing even brighter.

K V Subramaniam President and CEO, Reliance Life Sciences

The Indian biotech industry grew threefold in five years to register revenues of $ 3 billion in 2009-10, a rise of 17 per cent over the previous year. This data comes from the eighth annual survey conducted on more than 150 biotech companies by the Association of Biotechnology-Led Enterprises (ABLE) and a monthly journal. Reliance Life Sciences (RLS) has performed well this year, with significant growth in revenues. The company expanded its geographic reach for marketing and sales of its products and services. RLS launched its fifth biosimilar – Follicle Stimulating Hormone (FSH) – in the Indian market. Also, RLS has slated the launch of more biosimilars in the Indian market and further strengthened its pharmaceutical formulations portfolio. It plans to expand its product-market footprint that will bring sustainability to cash flows.

February 2011 I Modern Pharmaceuticals

Further, RLS plans to adopt a three-pronged growth strategy.

The first aspect would be to expand and develop the product pipeline. The second aspect would be geographic expansion of sales and marketing infrastructure. The company plans to export its biopharmaceutical and pharmaceutical products to semi-regulated markets, which will add significant revenues. The last aspect would be expansion of manufacturing capacities and capabilities to meet growing product demand.

In the next five years, RLS plans to expand its biopharmaceutical and pharmaceutical product portfolio. It would also target developed markets for the launch of some of these products.

The company would focus on developing its novel product portfolio, which is at an interesting stage of development today.

In order to meet product demand growth, RLS would expand its manufacturing capacities and capabilities for biopharmaceutical and pharmaceutical products.

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Market Trends

Educa on in R&D

Scanning the research path It is not just the theore cal knowledge but also the opera onal skills that make a difference in the educa on of R&D. And, is the job prospect in this arena same as before?

Chandreyee Bhaumik

C

ontrolled and carefully organised research enables the researchers involved to test and compare different approaches; derive theories by exploring different methods; and learn from the experience. Mostly, the findings, the statistics and the recordings ensure that the results can be applicable to a general use. Usually, the group of people who participate in a research are representative of several categories. An offshoot of medical science – clinical research – ascertains the efficacy of medications, devices, diagnostic products and treatment regimens intended for human use. The business is expected to assume an estimated worth of over $ 1.5-2 billion, as the country continues to receive attention in the field of clinical research. It is mandatory for a new drug or vaccine to undergo the process of clinical research

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before these are introduced in the market. A sound academic background pertaining to the requirements of this field and prior industry experiences along with practical training impart a deeper knowledge in research. However, the practical training and, to be more precise, the operational skills that are currently given in the course is hardly considerable.

Sunil Choksi, CEO, Choksi Labs Ltd, says, “The current education system is more concerned with getting the basics right. The methodology is devised to ensure that the knowledge of the subject is imparted for future progress.

We also need to create a vocational training environment for continuous development and thus focus more on reasoning and its effect.”

India on the globe Institutions are coming up all over the country to help train students in clinical research. Shruti Pande, Clinical Research Associate, International Clinical Research, Wockhardt, says, “The education scenario is much more developed in India as

compared to that in China. We have several tools like tailor made courses, free seminars, guest speakers, panel discussions and financial assistance for the young talent group in India.”

Further, the education in R&D helps in keeping pace with the global advancements of pharma research, encompassing the innovative curriculum that meets high economic standards. Therefore, the institutes should be well equipped with updated infrastructural facilities like library, computer laboratories, online training and audio-visual facilities along with placement cells. In this context, international collaborations also play a vital role.

Collaborate to educate Tie-ups with overseas institutes help organisations to leverage on mutual benefits. Thus, they help in paving a long way that launches and boosts India to become a dominant player in the area of research. Dr Jo Ritzen, President, Maastricht University, avers, “In general, the focus of building research in India is through high-quality partnerships.

This would bring a seamless exchange of ideas and facilitate contemporary research knowledge across the interface, exchange of students and faculty, etc, making it a true creative process.” Maastricht

The current educa on system is more concerned with ge ng the basics right. The methodology is devised to ensure that the knowledge of the subject is imparted for future progress.

- Sunil Choksi CEO, Choksi Labs Ltd

Modern Pharmaceuticals I February 2011

Market Trends University (UM) has tied up with National Law University, Indian Statistical Institute (ISI), National Institute of Mental Health and Neuro Sciences (NIMHANS), with an aim to facilitate the process of research on both ends. Thus, the long-term objective is to drive social impact through research. This is more evident from the research themes that are being pursued or those under consideration. Dr Ritzen elaborates, “Public health & hospital management, artificial intelligence, international business development, international intellectual property law and redistributive effects between countries of varied economic conditions are various outcomes of such partnerships.”

He adds that exchange of knowledge, especially regarding fast changing landscape of environment regulations, and opportunities for emerging economies is an important consideration in this context.

Industry-academia partnerships have always been extremely important and it brings together three primary components of discovery, viz, ‘what’, ‘how’ and ‘who’. Dr Ritzen opines, “Every discovery project would require a definition of ‘what’ to be delivered and, subsequently, the ‘how’ and ‘who’ elements of it. The industry with its consumer/customer connect is reliable in defining the ‘what’, and the academia with its knowledge and training can effectively decide on the ‘how’ and ‘who’ of that. With a creative management of the industryacademia interface, nothing can be more effective than a partnered research.”

We have several tools like tailor made courses, ee seminars, guest speakers, panel discussions nd financial assistance for the young talent group in India.

- Shru Pande Clinical Research Associate, Interna onal Clinical Research, Wockhardt

oriented topics in the syllabus.” Again, it is believed that internship programmes help students to get a hands-on experience of the jobs in this area. On this, she comments, “They learn the applications and the real scenario of operations in the industry. The internship programmes should be encouraged more.”

Job prospects The search for placements/jobs is an inevitable truth in any field. Pande opines, “Today, the jobs that are available are comparatively less than what it was 3-4 years back. In 2005, when the patent law was changed, the demand was more in this sector. Thus, in that year the vacancies were also higher. The 2005-07 batch of ICRI was absorbed at a faster rate since the demand was more than supply. This has comparatively declined now because more institutes have come up since then.” Pande continues, “Usually, clinical research organisations offer better remuneration than pharma companies, but the perks offered by pharma companies are comparatively more.”

Government support Innova ve curriculum Extensive syllabus along with internship programmes forms the texture of any education programme. Pande reiterates, “Various institutions like Institute of Clinical Research (India) (ICRI), CREMA, Garware and so on have set a defined syllabus (theoretical) to impart proper knowledge of clinical research. The syllabus is robust and exhaustive, comprising all sectors of clinical research. Industrial experts are often called to share their experiences and give tips on the essential aspects. However, some changes are required, so there can be more practicalFebruary 2011 I Modern Pharmaceuticals

Discussing the government’s role Pande opines, “Earlier, there were no institutes by the government. Now, Mumbai University has some plans in this regard. However,

semi-private and private institutes have gained prominence. But, to sum up, both government and private institutes are now making efforts to get the best faculty on board. They are trying to make the syllabus as practical as possible.”

Crossing over According to details offered by Clinical Trials Registry-India (CTRI), the number of registered clinical trials in India is 1,400, while China records 52,000 and the US is even higher on this number. Pande avers, “The notion that ‘India is a hub of clinical trials’ is a myth. She says that Drug Controller General of India (DCGI) has stated a reason for such discrepancy in numbers.

He said that in India, in spite of CTRI making it a mandatory affair, several pharma companies have not registered their clinical trial details. though the official records show that it is 1,400, there are definitely more number of such cases.”

But, the situation is not as grim as it appears. In the US, one must register at CT.GOV for clinical trials, failing which a penalty of $ 10,000 is to be paid.

Thus, in India the investigators and pharma companies need to be strict in their approach. MPh (chandreyee.bhaumik@infomedia18.in)

search in India is through high-quality partnerships. would bring a seamless exchange of ideas across the interface, exchange of students and faculty, etc, making it a crea ve process.

- Dr Jo Ritzen President, Maastricht University

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Retail Zone

Crea ng a sense of employee ownership

For a profitable retail business The high employee a ri on rate is a problem being faced by almost all companies. So, they need to make the job more sa sfactory and the workplace employee-friendly. They must ensure that employees develop a sense of ownership, which would boost their morale and mo vate them to improve performance, resul ng in be er outcomes. to create a sense of ownership in chain stores, as the owner or promoter rarely gets time to spend in the stores. Thus, every employee must treat the store as his own. Also, the shop-floor staff should know the customers well, so that customers are comfortable with the staff they deal with on a regular basis, to the extent that, if the employee moves on, often the customers also go away. So retaining the shop-floor staff is crucial to the retail business.

Developing ownership

A

sk any major retailer about the biggest recurring problem, and the response would be: ‘It is difficult to get good trained shop-floor staff ’. Even if they get some, the employees stay for a while to learn and then move on for better jobs. In some cases, the employee attrition ranges

Rajendra Pratap Gupta International Healthcare Expert & Speaker

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from 15 to 40 per cent. The problem is acute for pharmacy retail, as having a pharmacist is a mandatory expense and a regulatory requirement, and all pharmacists are not customer service or marketing oriented. Thus, having a good ‘helper’ (assistants to pharmacists) is a big challenge. Also, once these ‘helpers’ learn to read prescriptions, they exit for a better job.

Lack of morale or lack of a sense of ownership is the major problem for any pharmacy or retail chain. But why create a sense of ownership in the first place?

The reason is precise and simple. If the employees do not treat the business as their own, the sales and profit will always remain elusive. It is important

Can ‘ownership’ be taught or only good employees need to be hired? The fact is that all employees cannot be like ‘masters’. Some will be very good, some very bad and some average. So, what should be done to get the best out of the employees and develop a sense of ownership and loyalty in them to motivate them to deliver their best and, in turn, lead to better outcomes?

It is important to understand that employees work for four things: Salary and position (tangible) Growth and certainty (partly tangible) Vibrancy in job (intangible) Relationship with senior management (intangible) Salary & position: Now that it is clear what the key contributors are for an employee to stick to his job, it can also be figured out how to create a sense of ownership in employees, without giving away stakes. Salary and position is a given. Without a proper salary & designation, an employee cannot be expected to work. If the employee Modern Pharmaceuticals I February 2011

Retail Zone gets less salary, he will find other ways to make money or find another job after the desired experience and at the next available opportunity. Therefore, the salary must be competitive. The question is, how can the staff be paid more in a business like a pharmacy, which has fixed margins and where the business is so competitive?

One must have a fixed portion of the salary that is market linked or slightly lower, but still, possible to give a higher total remuneration to the employee. The salary could carry incentives like slab-based profit linked incentive (higher profit, higher variable component of salary), or based on the shrinkage (lesser the shrinkage, higher the variable component) or customer service standards (lesser the complaints, higher the variable pay), or product bouncing-prescription fulfillment (higher the fulfillment, higher the incentive). Thus, every action of an employee is tied to rewards. This creates a sense of ownership for deliverables or the Key Performance Indicators (KPIs).

Growth & certainty: As a person performs and stays with the company, he/she must be made to feel that he has built a relationship, which is an achievement, and it should be celebrated. For example, an employee who stays for three years, gets an increment or a milestone award – say, a cash prize of ` 3,000. This gives a sense of pride among people. Same can be done for 5, 7 and 10 years of service.

Each milestone pushes the employee into a comfort zone and creates a sense of belonging.

As an employee reaches a certain milestone, he/she must also get a higher level of personalised training and responsibility, so that the he/she not only grows old but also grows up with time and learns more.

Organisations that spend on training get better employees that last longer.

A key requirement of employees is to learn more from the job and enhance their skills. This also contributes to triggering a sense of ownership.

February 2011 I Modern Pharmaceuticals

Vibrancy in job: Vibrancy is when one feels excited about going to work every day. Key factors are friendly colleagues, compassionate senior management, realistic targets, fun to work, learning new things, family-office picnics, etc. Connecting employees’ families to the company’s top bosses is a great relationship builder – this relationship also leads to a sense of ownership. It works well to reward an outstanding achievement of an employee’s family member, like his child achieving well in studies or sports.

Quick Picks If employees are given clear responsibilities and powers to act, they enjoy the freedom and feel more responsible (accountable) and have a sense of ownership Employee newsletter: Creating a newsletter, especially for employees to share about their families and professional achievements is also a good idea. This goes a long way in connecting employees with each other and creating an atmosphere where people feel they are working for a family and not a company; thus, the dedication levels go up drastically.

Relationship with senior management: Formal retention strategies include a stake for employees, sharing a fixed portion of profits tied to KPIs or giving stock options that vest every year. The longer the employees stay with the organisation, the more stock options they earn (as the options vest every year). And, if the employee leaves the organisation, the stocks options also cease to exist.

Most companies believe that if the employees work hard, the value of stock options would increase. Also, the valuations of the company and earnings of employees would increase, as better performance of companies would bring in better profits for employees (since the total value of

their stock options would increase).

Companies in India have started sharing their fortunes with their employees. It is now being felt that informal relationships build a stronger bond than a formal stake-driven strategy. Employees at the shop-floor level value personal relationships. A better idea is to give stock options or share a percentage of profits and also build strong informal relationships to boost employee morale and build loyalty. For decades, it is has been an established practice in the pharma industry that when the top man exits, the entire team exits with him and joins his new company, as the boss had built an excellent personal relationship with his team.

People down the line have a great value for emotions, the way they feel connected at their workplace and how much they are heard by their senior management. Experience shows that if the senior management interacts often and takes action on the feedback, a sense of ownership develops among the shop-floor staff that he has heard, and thus he has a say in the scheme of things. This is irreplaceable when it comes to building trust and loyalty.

If employees are given clear responsibilities and powers to act, they enjoy the freedom and feel more responsible (accountable) and have a sense of ownership.

Building a bond Creating ownership is like building a relationship. If the company takes care of its employees, the employees will take care of it better. But this starts with genuine feelings for caring about one’s employees.

Creating a bond with employees and signing a bond for working, are two different things and give different results. Creating a bond works the best, as employees would go above and beyond the call of duty to ensure that the business is successful. Retail is never about location, but it is only about people. MPh (mail@rajendragupta.org)

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Curtain Raiser

BioAsia 2011

Goes green!

‘Go Green’ seems to be the mantra industries are chan ng. On the same lines, BioAsia 2011 will have a special focus on green biotechnology along with other highlights. A preview…

Glimpses of the previous BoiAsia

Meghna Mukherjee

T

he eighth edition of BioAsia will be hosted from February 21-24, 2011, at the Hyderabad International Convention Centre (HICC), Hyderabad.

It aims to identify & address the key opportunities and challenges in the pharma industry. This time the edition will encompass discussions on green biotechnology, agribiotechnology, healthcare, bio-economy and bio-infrastructure.

Reflec ons 2010 The emphasis of BioAsia 2010 was on bio-partnering and tradeshow that comprised conferences, tradeshows, thus providing a platform for the B2B industry, to network. A four-track conference model concentrated on topics like medical biotechnology, biopharmaceutical, agriculture biotechnology and animal biotechnology.

The event saw over 100 speakers during 92

30 sessions. Besides, there were more than 6,000 delegates and visitors.

Opportuni es this year The major attraction at this year’s BioAsia is the CEO conclave panel discussion on the theme, ‘Looking back, Looking forward’, to be hosted on February 22, 2011. The conclave will see industry bigwigs like Dr Anji Reddy, Chairman, Dr Reddy’s Laboratories; Dr D S Brar, Promoter Chairman, GVK Bio; Dr Roger L Williams, CEO, US Pharmacopoeia; and Dr Shailesh Ayyangar, Vice-President (South Asia), sanofi-aventis.

This event will be inaugurated by K Kiran Kumar Reddy, Chief Minister, Andhra Pradesh, and Kapil Sibal, Union Minister for HRD, Science and Technology and Telecommunications.

Highlighting on the CEO conclave, Dr B S Bajaj, Convener, BioAsia 2011, informs, “The CEO Conclave will be open to all registered delegates, in addition to 200 special invitees.

We expect a total of 400 participants for the conclave.”

Lonza Bioscience, Biocon, Ranbaxy, Piramal Life Sciences, Novartis, Zydus Cadilla, Neuland Labs, The French National Institute for Cancer, Natco Research, Centre for Cellular and Molecular Biology, Department of Biotechnology, Government of India, Gland Pharma and Bharat Biotech are expected to participate this year.

The event highlights will be divided into three-track conferences –MediAsia, HealthAsia and AgriAsia. According to Dr Bajaj, “BioAsia 2011 will stand out for a unique format focussed on industry interactions and B2B meetings.”

The inaugural session will also witness the ground breaking ceremony of Lonza’s facility and Biotech Innovation Centre of Alexandria Real Estate Equities Inc, both of which are located at Genome Valley, Hyderabad.

The trade show this year is expected to reach out to over 10,000 participants for collaborating with the global biotech community.

BioAsia 2011 will bring together decision makers from the government, business development executives, biotechnology, healthcare industry. scientists from R&D institutions, technology transfer and Intellectual Property Right (IPR) specialists.

BioAsia 2011 is being organised by the Federation of Asian Biotech Association (FABA), Genome Valley, Government of Andhra Pradesh, University of Hyderabad and All India Biotech Association. The event is co-organised

by Pharmexcil. MPh (meghna.mukherjee@infomedia18.in)

Modern Pharmaceuticals I February 2011

Events Calendar

National CHENNAI Tamil Nadu Mar 11-13, 2011 Chennai Trade Centre

AHMEDABAD Gujarat Oct 14-17, 2011 Gujarat University Exhibition Hall

PUNE Maharastra Nov 18-21, 2011 Auto Cluster Exhibition Centre

INDORE Madhya Pradesh Jan 6-9, 2012 Poddar Plaza, Nr Gandhi Hall

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

For details Infomedia 18 Ltd,

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

• Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in

PharmaTech Expo 2011 Jointly organised by PharmaTechnology Index.com and IDMA, this event aims to be the largest pharma expo in Indore. The objective of this event is to project the latest technological trends in the pharma industry, facilities & services available, quality control and government regulations.

The event will showcase latest products, machinery, equipment related developments in the industry; April 22-24, 2011, Lal Baugh Palace Grounds, Indore For details contact: IDMA Tel: +91 22 2497 4308 Fax: +91 22 2495 0723 Email: prach17@gmail.com Website: www.idma-assn.org

11th Bangalore India Bio 2011 Bangalore Bio will offer unrivalled opportunity in the Asia Pacific region to meet the leaders in the biotech world.

The exhibitors profile includes bio-nations and states, R&D organisations, bio-pharma companies, bio-suppliers, bioinformatics, engineering & equipment, biotech parks, diagnostics & instrumentation, clinical research, consulting and allied services. The event will witness industry and corporates, trade commissions, international business representatives, conference delegates, regulators, policy makers, etc; May 4-6, 2011, BIEC, Bengaluru

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For details contact: M M Activ the Sci-Tech Communication Tel: +91 80 4113 1912 Fax: +91 80 4113 1914 Email: redmanjunath@gmail.com Website: www.bangaloreindiabio.in

2nd Pharmac India The three-day event will cater to the pharma and healthcare industry in the country. It aims to attract reputed professionals from the fields of pharmaceutical formulation, herbal products, veterinary drugs, medical & disposal products and pharma machinery & equipment. The event will have exhibitors like contract manufacturers, liaison agents, sourcing companies, generic & OTC manufacturers and wholesalers, government suppliers, etc; September 1719, 2011; Gujarat University Exhibition Hall, Ahmedabad For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91 22 2410 2801 Fax: +91 22 2410 2805 Email: info@pharmacindia.com Website: www.pharmacindia.com

Analytica Anacon 2011 Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology and laboratory technology & services.

It aims to bring together international exhibitors and market leaders. The event will provide an excellent opportunity to showcase innovative products and solutions in the industry;

October 12-14, 2011; Bombay Exhibition Centre, Mumbai For details contact: Munich International Trade Fairs, New York, USA Tel: +1 646 437 1013 Fax: +1 212 262 6519 Email: jliehn@munich-tradefairs.com Website: www.munichtradefairs.com

CPhI India 2011 The event will feature key decision makers in the pharma industry from 92 countries, including India, China, US, UK, France, Italy, etc. Major suppliers of pharmaceutical ingredients, outsourcing, equipment and bio-solutions are also expected to exhibit their products. The CPhI conference will have updates on latest innovations, technologies, trends and developments in the pharma industry in India; November 30-December 2, 2011; Bombay Exhibition Centre, Mumbai For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

Pharmapack Bombay PharmaTek aims to provide an innovative platform to showcase the latest information, technology and products to a target audience.

The event will cater to exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc. The exhibitors list includes plant & machinery for pharma production, bulk drugs, intermediates & formulations, raw materials & excipients, R&D, instruments and materials, etc; February 23-25, 2012, Bombay Exhibition Centre, Mumbai For details contact: Intel Trade Fairs &Expositions Pvt Ltd Tel: +91 22 2862 8126 Fax: +91 22 2281 9008 Email: intelexpo@vsnl.net Website: www.intelexpo.com

Modern Pharmaceuticals I February 2011

Events Calendar

International ARABLAB 2011 ARABLAB is the global buying source for tomorrow’s technology makers & end-users, as well as a unique research source.

Connecting people from over 75 countries, this expo will showcase the latest lab and instrumentation equipment from the world’s leading manufacturers; March 7-10, 2011; Dubai International Convention & Exhibition Centre, UAE For details contact: The ARABLAB Group Tel: +971 4 397 5418 Fax: +971 4 397 5419 Email: info@arablab.com Website: www.arablab.com

BIOTECH WORLD 2011 The exhibition will show processes & devices for biotechnological productions and laboratory researches, biological preparations for pharmaceutical, food, agricultural sector and also biological agents, bioactive additives, test-systems, alternative energy sources, nano-molecular energy converters, laboratory safety, etc; March 21-24, 2011; The House of Moscow Government, Russia For details contact: JSC Expo-Biochim-Technologies Tel: +7 495 933 9051 Fax: +7 495 933 9054 Email: atv@biomos.ru Website: www.mosbiotechworld.ru/eng

Tel: +971 4 362 4717 Fax: +971 4 362 4718 Email: index@emirates.net.ae Website: www.duphat.ae

International China Pharmaceutical R&D Summit The 6th International China Research and Development (R&D) Summit 2011 will bring together over 80 speakers from international and domestic pharma & biotech companies to share expert opinions & experiences on transformation and innovation in clinical challenges, regulatory updates, NCE discovery efforts, pre-clinical partnerships, biosimilars development, etc; April 11-13, 2011; Grand Hyatt Hotel, Shanghai, China For details contact: IBC Life Sciences and BayHelix Group Tel: +65 6508 2401 Fax: +65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifesciences.com/china

International Pharmaceutical Exhibition The International Pharmaceutical Exhibition will bring together manufacturers and suppliers of process plant & equipment.

This exhibition will provide a platform for service providers to showcase their products and services to decision makers from leading pharmaceutical manufacturers; May 10-12, 2011; Charlotte Convention Centre, Charlotte, USA

services. The event will enable business partnerships, launch new products and showcase innovations; June 21-23, 2011; Shanghai New International Expo Centre (SNIEC), Shanghai, China For details contact: Cphl China 2011 UBM International Media Tel: +31 0 204 099 593 Email: haohao.chen@ubm.com Website: www.cphi-china.com

ICSE Europe ICSE Europe aims at targeting the top leaders of the pharma industry. The event will organise an exhibition alongwith concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipment and machinery, production equipment, clinical research, patient safety monitoring, etc. The visitors list includes medical and clinical staff of biotechnology and pharmaceutical companies, corporate management, planning and marketing staff, etc; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany For details contact: UBM Live Tel: +31 20 409 9544 Fax: +31 20 363 2616 Email: icse@ubm.com Website: www.icseexpo.com

Bio-Europe Spring 2010 DUPHAT 2011 Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) is an annual pharma event. It serves as a convergence point for pharmacists, scientists, researchers, manufacturers, distributors, etc; March 22-24, 2011; Dubai International Exhibition Centre, UAE For details contact: Index (Conferences and Exhibitions Organisation Est)

For details contact: Arosa Exhibitions Ltd Tel: +1 980 219 8449 Email: gviniconis@arosa-group.com Website: www.charlotteconventionctr.com

Bio Europe Spring 2011 is a forum to promote business development between pharmaceutical, financial and biotechnology companies in Italy; November 14-16, 2011; Milano Convention Centre, Milano, Italy

CPhI China 2011

For details contact: BIO (Biotechnology Industry Organization) Tel: +1 202 962 9200; Fax: +1 202 488 6301 Email: cbeckman@bio.org Website: www.bio.org/events

CPhl China is a platform where pharmaceutical manufacturers, biopharm aceutical companies, biotechnology companies and API manufacturers will display a variety of products &

The information published in this section is as per the details furnished by the respective organiser.

In any case, it does not represent the views of Modern Pharmaceuticals

February 2011 I Modern Pharmaceuticals

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Product Update Fermentor/bioreactor Shree Biocare India offers fermentor/bioreactor. The company offers lab scale, pilot scale fermentors.

These are optimum quality fermentors and are developed & designed for microbiology, pharmaceuticals, DNA, proteins, cell culture, biofertilisers, vaccines, biopesticides, biofuels or customer application & requirement. Biocare fermentor offers glass vessel, glass vessel with SS jacket, complete SS vessel autoclaveble or in situ (in place) sterilisation, 3-1000 ltr with controlled parameters such as agitation, aeration, pH, temperature, antifoam, DO or other special parameters. Biocare fermentors are PLC-based, with touchscreen module or LCD module attached with PC and software data as per GMP/GLP. Biocare also offers IQ/PQ/OQ documentations.

Shree Biocare India - Ahmedabad - Gujarat Tel: 079-4008 4116, Fax: 079-4008 4116, Mob: 09898999146 Email: shreebiocare@gmail.com

MVE cryogenic systems Sigmatech Scientific Products offers MVE Cryogenic system series. This series combines the benefits of low nitrogen consumption with mid-range vial capacity to meet the diverse needs of today’s professionals worldwide. The lightweight and low-space demands of these containers make them the most economical units in their class. Its static evaporation rate and static holding time are nominal. Actual rate and holding time are affected by the nature of container use, atmospheric conditions and manufacturing tolerances. Normal working duration is an arbitrary reference to estimate container performance under normal operating conditions. Actual working time may vary due to current atmospheric conditions, container history, manufacturing tolerances and individual patterns of use.

Sigmatech Scien fic Products - Hyderabad - Andhra Pradesh Tel: 040-6453 4491, Fax: 040-4003 1896, Mob: 09849632904 Email: s_tech07@yahoo.com

Con nuous inkjet printer Bakshi Mark offers continuous inkjet printer. The Linx 7300 printer provides fast, non-contact printing of static & dynamic codes, messages on almost any moving surface in the production line. It provides a flexible coding solution, which is designed to be easy to use in any environment. It has a simple to use qwerty keyboard and multicolour display screen, which 96 96

allows easy code creation and editing, a robust design for trouble-free operation and a powerful feature. Linx 7300 has a USB message & printer back up & restore and has mistake proofrefills with ‘surefill’ code.

Its rebundled features include standard 3 lines of print, longer service intervals (dynamic adjustment up to 6,000 hours or 12 months), mistake proof message selection (rebranding DIP to QuickSwitch) and standard data matrix. It also has an easy to clean enclosure.

Bakshi Mark Pvt Ltd - New Delhi Tel: 011-2526 2395, Fax: 011-4299 0011, Mob: 09711200744 Email: info@markode.in

Differen al pressure transducer Katlax Enterprises offers Differential Pressure Transducer (DPT). The transducer measures pressure differences between two points and give proportional analogue output (0-10 V or 4-20 mA). It has unsurpassed performance due to Complementary Metal-Oxide-Semiconductor (CMOS) technology, offset and hysteresis free. It has excellent accuracy and reproducibility; even below 10 Pa, it is fully calibrated and temperature compensated with out being sensitive to mounting orientation. Its sensor continuously monitors differential pressure between two ports. Integrated circuit converts differential pressure to electrical signal (0-10 V or 4-20 mA). An optional microcontroller-based circuit is also available for future upgradation to connect with Supervisory Control & Data Acqusition (SCADA) on Modbus protocol and conditioning/control circuit can be supplied in enclosure (IP66). This device can communicate on different communication protocols, ie, Modbus, RS232, RS485, etc. Katlax differential pressure transducers are available with various measuring ranges that starts from -0.5 mbar to 100 mbar. This is applicable in Variable Air Volume (VAV) systems; Heating, Ventilating and Air Conditioning (HVAC); filter pressure drop; fan/ventilator control; duct air flow measurements; room/ cabin pressure control; burner control; CPAP equipment; sleep apnoea monitors; air handling units; textile air engineering and pharmaceutical industry.

Katlax Enterprises Pvt Ltd - Gandhinagar - Gujarat Tel: 02764-286 784 - 85, Fax: 02764-286 793 Email: info@katlax.com Modern Pharmaceuticals I February 2011

Product Update Transmi ers Ace Instruments offers digital differential pressure transmitters.

These are high-accuracy differential pressure transmitters with integrated display & 4-20 mA output. The transmitter has a 4-digit red LED display 0.5” high with 0.1 decimal resolution. Industry standard 2-wire 4-20 mA output is available as standard output. The option of 0-5 V or 0-10 VDC output is also available. These are available in ranges from -10.0 to +10.0 mm; WC 0.0 to 10.0, 20.0, 25.0, 50.0, 100.0, 500.0, 1000, 2500, 5000 and 10,000 mm WC. These instruments are also available in Pascal unit of measurement.

Other standard metric units that can be accommodated include cm WC, in WC, in Hg, mm Hg, etc. These instruments are available in all three versions of differential pressure, gauge pressure & vacuum. For gauge pressure & vacuum, option of ¼” BSP male threading is available for direct mounting on to system. These transmitters are used in pharmaceutical clean rooms, air handling units, HEPA filters, filters, pharma machinery, etc.

Ace Instruments - Hyderabad - Andhra Pradesh Tel: 040-2307 8848, 3290 1226, Fax: 040-2307 8848, Mob: 09394030848 Email: sales@aceinstrumentshyd.com

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Product Update High eďŹƒciency freezers Eppendorf India offers High efficiency freezers from New Brunswick Scientific (NBS). This minimises operating costs and laboratory space requirements, while providing superior protection for critical samples. Its 570 and 410 ltr upright models, and 660 ltr chest model are the first in the new HEF line, consuming up to 65 per cent less energy than competitive units. These systems significantly lower carbon impact on the environment when compared to competitive units and also meet the conformance with government, industry and environmental directives. This has been made possible by combining superior-performing vacuum insulation panels with additional insulation techniques and using environmentfriendly, more efficient hydrocarbon refrigerants instead of traditional HFCs in 50 Hz models.

Eppendorf India Ltd - Chennai - Tamil Nadu Tel: 044-4211 1314, Fax: 044-4218 7405, Mob: 09380176423 Email: info@eppendorf.co.in

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Modern Pharmaceuticals I February 2011

Product Update Mul mill & cone mill Jicon Machines offers multi mill & cone mill for granulation, pulverising, shredding and chopping of dry and wet materials.

The rotor, hopper, discharge bowl and other equipment can be easily removed for cleaning. The rotor has 12 blades with blunt and knife edges for hammering and cutting action and is easy to remove.

The speed of this mill is variable and reversible. It is mounted on a standing mobile platform with castors for easy movement.

Different mounting structures are available as per client’s requirement. The output varies from 100 to 800 kg per hour depending on product and screen. The cone mill is ideal for wet, sticky, heat-sensitive materials. Gentle grinding action ensures uniform particle size, minimising fines and dust. The cone mill’s output varies from 100 to 500 kg per hour depending on product and screen.

Jicon Machines Pvt Ltd - Mumbai - Maharashtra Tel: 022-2851 0398, Fax: 022-2851 6488 Email: jicon.ind@vsnl.com

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Product Update Analyser TTL Technologies offers ‘DIPA 2000’ particle size and shape analyser from Donner Technologies.

It combines two complementary measurement techniques by integrating laser and video channels. It provides complete sample information on particle size distribution and numerous particle shape parameters with the help of very high analytical resolution (analysing each sampled particle individually) and real-time sample visualisation. The analyser has a wide measurement range of 0.1-5,000 microns. It comes bundled with the software for comprehensive data analysis and report generation.

The instruments can be fitted with a variety of modular measurement cells, which can be manually interchanged to allow for particle analysis in liquids, emulsions, creams, dry powders, fibres, heated liquids, aerosols and more, with minimal (or no) sample intervention and original state analysis. Analytical data can be displayed in a wide variety of tables and graphs.

TTL Technologies Pvt Ltd - Bengaluru - Karnataka Tel: 080-2525 1859, Fax: 080-2529 1285 Email: analyticaldirect@ttlindia.com

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Product Update Hose reels Cris Engineering Works offers stainless steel hose reels that are designed for heavy-duty use with a canvas-reinforced rubber/Teflon-braided stainless steel water hose. Using a heavy-duty internal spring, the reel quickly and easily rewinds the hose. These are provided with a ratchet assembly, which locks the reel when the desired length of hose has been pulled out. All hose reels are preset with enough force to fully retract the hose. Hose reels can be conveniently installed on pillars, walls or ceiling for easy access & maintenance and are offered in fixed or swivel designs. Each hose reel includes a hose stop to prevent damage to the hose reel rollers and water-saver nozzles. These self-rewind hose reels are manufactured for pharma, food, chemicals, dairy, beverage and allied industries. These are available in 5-, 10- or 15-m long hose with diameter of ½” or ¾”, with a maximum working pressure of 10 bar and maximum working temperature of 100°C. Cris Engineering Works - Mumbai - Maharashtra Tel: 022-2685 9440, Fax: 022-2685 9440 Email: roque_ferns@rediffmail.com

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 Pharmaceuticals

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Product Index Sl No Product 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81

Pg No Sl No Product

Accelerated ageing test............................... 39 Access control................................................ 99 Acoustic enclosures....................................... 41 Air filters ..................................................63, 65 Air shower controllers.................................. 99 Alpha press ...................................................... 8 Analyser........................................................ 102 Analytical instrumentation..................67, 106 APFC panels .................................................. 69 Auto tube filling sealing machine............... 71 Autoclavable fermentor................................ 23 Autoclave gaskets ........................................ 102 Ball check valve ..................................... 19, 84 Banking services............................................ 49 Bearings.......................................................... 10 Bend................................................................ 84 Biodiesel ......................................................... 39 Biological safety cabinet.........................63, 65 Blister packaging machine........................... 71 Blistrip............................................................ 71 Blowers ........................................................... 66 Braided house.............................................. 102 Bush................................................................ 19 Butterfly valve..........................................19, 84 Cable carriers .............................................. 10 Cable connectors........................................... 10 Cables ........................................................... 102 Calibration sources....................................... 25 Capping machines .......................................... 9 Capsule section machines............................ 71 Chain pulley block...................................... 101 Chains............................................................. 10 Chromatography......................................... 106 Clean room clocks ........................................ 37 Clean room doors...................................63, 65 Clean room monitor .................................. 100 Coating machine............................................. 8 Colloid mill std/GMP model ........................ 8 Coloumns & chemistries .....................67, 106 Communiting mill.......................................... 8 Complete tablet bottle packing lines............ 9 Compositional & trace metal analysis ....... 39 Conductivity.................................................. 25 Conical screw dryers....................................... 7 Connectors..................................................... 10 Continuous inkjet printer............................ 96 Contract research & manufacturing fermentor process....................................... 23 Controllers ..................................................... 25 Cords ............................................................ 102 Corona treater sleeves ................................ 102 Counters & power supplies ............................................Front inside cover Crabs............................................................. 101 Crane ............................................................ 101 Crushed ice machines ................................ 101 Crushers ......................................................... 11 Cryocans ...................................................... 101 Data acquisition fermentor software....... 23 De-dusting & de-burring............................... 8 Diaphragm valve.....................................19, 84 Differential pressure transducer.................. 96 Digital clocks ................................................. 35 Digital differential pressure indicators....... 35 Digital differential pressure transmitters ... 35 Digital panel meter....................................... 13 Dispensing booth....................................63, 65 Distribution transformer ............................. 69 Door interlock systems ................................ 99 Double acting hydraulic cylinder ............... 12 Double rotary tableting machine ................. 8 Double sided rotary...................................... 29 Drging oven..................................................... 8 Drives.................................... Back inside cover Dry heat steriliser.......................................... 23 Dry syrup powder filling lines ...................... 9 Dry vacuum pumps ................................... 103 Dry van pumps ............................................. 41 Dust extractor ................................................. 8 Dynomill........................................................ 55 Electrical (both ht & lt).............................. 99 Elemental analysis....................................... 106 Empower........................................................ 67

104

82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162

Pg No Sl No Product

Encoders..............................Front inside cover End cap .......................................................... 84 Ensule automatic capsule filling ................. 71 EOT/HOT cranes........................................ 101 Evaporative cooling tower ........................... 21 Exhausters...................................................... 66 Factory automation..............Cover on cover Failure analysis .............................................. 39 Fan filter unit...........................................63, 65 FDBD gaskets .............................................. 102 FEP/PFA/PVDF material ............................. 19 Fermentor or bioreactor .............................. 96 Fermentor projet management solutions... 23 Fermentor refunishing ................................. 23 Fill tube .......................................................... 71 Filler compositional analysis ....................... 39 Filling equipments ........................................ 17 Filter cock ...................................................... 84 Filters .............................................................. 11 Filtration equipment .................................... 11 Financial services .......................................... 49 Fire alarm....................................................... 99 Fittings............................................................ 19 Flame proof clocks ....................................... 37 Flame proof hoist ....................................... 101 Flame proof pH ............................................ 25 Flow indicator ............................................... 84 Fluid bed system ............................................. 8 Fogging machine......................................... 102 Food analysing & testing machine ............. 11 Foot valve....................................................... 84 Force feed lubricator .................................... 12 Fuels................................................................ 39 Fumigation .................................................. 102 Gases............................................................. 39 Gaskets ...................................................19, 102 Gear boxes ................................................... 101 Gear oils ......................................................... 39 Gear pumps................................................... 61 Giga press......................................................... 8 Glass door refrigerators.............................. 101 Glass fermentor............................................. 23 GMP heat exchangers..................................... 7 GMP reactors .................................................. 7 Gold lab pH................................................... 25 Goliath crane............................................... 101 Goods lifting machine................................ 101 GPS clocks ..................................................... 35 HEPA filter terminal housing ............. 63, 65 High efficiency freesers ................................ 39 Horizontal sterliser ....................................... 23 Hose reels..................................................... 103 HPLC......................................................67, 106 Humidity & temperature transmitters....... 37 Hydraulic buffer............................................ 12 Hydraulic cylinders....................................... 12 Hydraulic jack ............................................... 12 Hydrogenator/autoclaves ............................... 7 Ice flakers ................................................... 101 Impeller.......................................................... 84 Indicators ....................................................... 25 Industrial control & sensing devices...............................Front inside cover Inflatable gaskets......................................... 102 Informatics..................................................... 67 Injectable manufacturing line ...............63, 65 Injectable powder filling machines............... 9 Innovators in vacuum technology.............. 99 Invertor/variable frequency drives .................................Front inside cover Isolation transformer ................................... 69 Jib crane ..................................................... 101 Knife mill ..................................................... 11 Lab conductivity ......................................... 25 Lab portable online pH ............................... 25 Lab scale fermentor ...................................... 23 Labelling equipments ................................... 17 Laboratory ice flakers ................................. 101 Laminar air flow workstation ...............63, 65 Level controllers .................Front inside cover Lipuid food processing................................. 11 Liquid filling machines .................................. 9 Liquid injectable equipments...................... 17

Pg No Sl No Product

163 Liquid manufacturing plant........................ 17 164 Liquid nitrogen storage & transport containers .................................................. 101 165 Ln2 containers............................................. 101 166 Long neck pipe end...................................... 84 167 Lubes-engine oils .......................................... 39 168 Mass mixer granulator................................. 8 169 Mass spectroscopy ...................................... 106 170 Material identificaton................................... 39 171 Measuring & monitoring relay for 1ph/3ph.............................Front inside cover 172 Mechanical vacuum boosters...................... 66 173 Medical refrigerators .................................. 101 174 Mega press ....................................................... 8 175 Metallography ............................................... 39 176 Mini roll compactor ....................................... 8 177 Molecular spectroscopy.............................. 106 178 Monoblock high vacuum pump .............. 103 179 Monorail trolley .......................................... 101 180 Motion controls .................Front inside cover 181 Motorised chain pulley block.................... 101 182 Mullers............................................................ 11 183 Multi mill & cone mill ............................... 101 184 Multi-function mill....................................... 11 185 MVE cryogenic systems ............................... 96 186 Non-return valve ........................................ 84 187 O rings........................................................ 102 188 Oil seal high vacuum pump...................... 103 189 Oil seals ........................................................ 102 190 Ointment / lotion / cream manufacturing plant ............................................................. 17 191 Ointment/cream/paste section machines...................................................... 71 192 Online B2B marketplace......................73, 104 193 Online TDS ................................................... 25 194 ORP ................................................................ 25 195 Packaging machinery............................. 9, 71 196 Paperless recorder ......................................... 13 197 Pass box inter lock systems.......................... 99 198 Pass boxes.................................................63, 65 199 Peristaltic pumps........................................... 14 200 Petrol & fuel oils ........................................... 39 201 PH electrodes ................................................ 25 202 Pharma refrigerators................................... 101 203 Pharmaceutical grinding & dispersion ...... 53 204 Photoelectric sensors.........Front inside cover 205 Pilot press......................................................... 8 206 Pilot scale fermentor .................................... 23 207 Pipe................................................................. 19 208 Plastic pallets ................................................. 93 209 Plug valve ....................................................... 19 210 Pneumatic component................................. 11 211 Pole ring......................................................... 84 212 Polymer characterisation ............................. 39 213 Potentiometer................................................ 25 214 Powder and granule paking equipments... 17 215 Power conditioner ........................................ 69 216 Power pack unit ............................................ 12 217 Power saver .................................................... 69 218 Pre-engineered & pre-fabricated modular panel.......................................................63, 65 219 Process controllers ........................................ 13 220 Process heat exchangers ................................. 7 221 Process reactors ............................................... 7 222 Production scale fermentor......................... 23 223 Profiles.......................................................... 102 224 Programmable logic controllers.........................Front inside cover 225 Programmable terminals ..Front inside cover 226 Proximity sensors...............Front inside cover 227 PTFE............................................................... 19 228 Puches & dies .................................................. 8 229 Pumps ............................ 41,61,87,100,101,103 230 Quality control equipments & apparatus ................................................... 71 231 Quick change terminal house ...............63, 65 232 Rapid endotoxin detection system......... 102 233 Reducer .......................................................... 84 234 Refrigerators ................................................ 101 235 Return air risers ......................................63, 65 236 RFID ....................................Front inside cover 237 Rod ................................................................. 19 238 Roll compactor................................................ 8

239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316

Pg No

Roots blower.............................................41,87 Rotary pumps........................................61, 103 Rotary tablet press ........................................ 29 Rotary vacuum dryers.................................... 7 Rotocone dryers .............................................. 7 Rupid mixer standard .................................... 8 Safe change housing............................. 63, 65 Safety light curtains ...........Front inside cover Sampling booth.......................................63, 65 Sandwich panels.......................................... 103 Screening machine........................................ 11 Sealing equipments....................................... 17 Sections ........................................................ 102 Separators....................................................... 11 Servo stabiliser ............................................. 69 SEZ developers........................ Front gate fold Sheets......................................................92, 102 Showel ............................................................ 84 Silicone carbide heat exchangers................... 7 Silicone rubber sleeves .............................. 102 Silicone transparent platinum cured tubings ....................................................... 102 Single acting hydraulic cylinder.................. 12 Single rotary tableting machine.................... 8 Single stage vacuum pump ....................... 103 Slipon flange.................................................. 84 SME finance .................................................. 49 Spade .............................................................. 84 Spherical paddle chopper dryers .................. 7 Sponges ........................................................ 102 Sterilising/depyrogenating tunnel.........63, 65 Sticker labelling machines ............................. 9 Strip seals ..................................................... 102 Supervising control fermentor software .... 23 Swing check valve ......................................... 19 Switching relays..................Front inside cover Synchronised digital clocks.......................... 35 Syrup manufacturing plant ......................... 17 Tablet press machine.................................. 29 Tablet section machines ............................... 71 Tablet/capsule packing equipment ............. 17 TC gaskets.................................................... 102 TDS conductivity.......................................... 25 Technology transfer for biofertiliser........... 23 Telecom .......................................................... 69 Telescopic cylinder........................................ 12 Temperature & differential pressure indicators ..................................................... 37 Tempurature controllers .......................................13, Front inside cover Testing system................................................ 39 Three parameter display .............................. 99 Timers .................................Front inside cover Transfer trolley ............................................ 101 Transmission fluids....................................... 39 Transmitters.............................................25, 99 Transparent tubings.................................... 102 Tri-lobe root blowers.................................... 66 Tubes .............................................................. 19 Turbula........................................................... 55 Turnkey projects .......................................7, 69 Twin-lobe root blowers..........................66, 87 Two stage vacuum pump......................87,103 UHPLC....................................................... 106 Ultrasonic flow meter .................................. 13 ULV fogging machine ................................ 102 UPLC.............................................................. 67 UPS................................................................. 69 Vacuum booster pump .............................. 41 Vacuum pumps........................................... 103 Vacuum systems............................................ 41 Valve...........................................................19,84 Ventilator........................................................ 31 Vision sensors.....................Front inside cover Washer.......................................................... 84 Washing and air jet cleaning machines ....... 9 Wastewater treatment equipment............... 11 Water ring vacuum pumps.......................... 87 Wet glue labelling machine ........................... 9 Wire rope hoist ........................................... 101 ‘Y’ type strainer........................................... 84

Modern Pharmaceuticals I February 2011

Advertisers’ List Advertiser’s Name & Contact Details Ace Instruments T: +91-40-23078848 E: sales@aceinstrumentshyd.com W: www.aceinstrumentshyd.com Acme Air Equipment Co Pvt Ltd T: +91-79-25831985 E: info@airequipments.com W: www.acmeairequipments.com Ani Engineers T: +91-2752-241479 E: anivarya@sancharnet.in W: www.anivaryapumps.com Arctic India Sales

Pg No 35

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E: guanyeu@ms39.hinet.net W: www.gy-1000.com.tw Igus India Pvt Ltd

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E: info@igus.in W: www.igus.in India Mart Intermesh Ltd

100

100

BIC

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29

T: +91-79-25841491

E: info@cadmach.com W: www.cadmach.com Chamunda Pharma Machinery Pvt Ltd

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T: +91-79-25842712

E: shahil@cm1981.com W: www.cm1981.com Charles River

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17

25

7

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E: sales@eltechservices.com W: www.eltechservices.com Everest Blowers T: +91-11-45457777 E: info@everestblowers.com W: www.everestblowers.com Fabtech Technologies Intl Pvt Ltd

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32

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E: aparadkar@jbsez.com W: www.jbsez.com Jicon Industries

FGF

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E: jicon.ind@vsnl.com W: www.jicon.com Joyam Engineers & Consultants Pvt Ltd T: +91-79-26569533 E: joyam@joyamvactech.com W: www.joyamvactech.com Milltech Engineering Pvt Ltd T: +91-22-22872295 E: info@milltechengg.com W: www.milltechengg.com Misumi India Pvt Ltd

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COC

E: sales@misumi.co.in W: www.misumi.co.in Netzsch Technologies India Pvt Ltd T: +91-44-42965121 E: anton.benjamin@nti.netzsch.com W: www.netzsch-grinding.com/pharma Omron Automation Pvt Ltd

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FIC

E: srirams@ap.omron.com W: www.omron-ap.com P.P.I. Pumps Pvt Ltd T: +91-79-25832273 E: sales@ppipumps.com W: www.ppipumps.com Parth Poly Valves Pvt Ltd T: +91-79-22200198 E: sales@parthvalves.com W: www.parthvalves.com Procon Technologies Pvt Ltd T: +91-79-27492566 E: info@procon.co.in W: www.procon.co.in Radiant Enterprise

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63, 65

21

T: +91-422-3267800

E: sales@gemindia.com W: www.gemindia.com

E: radiant_enterp@rediffmail.com W: www.fogstarindia.com Ravel Hiteks Pvt Ltd T: +91-44-24961004 E: sales@ravelhiteks.com W: www.ravelhiteks.com Sea Bird Refrigeration Pvt Ltd T: +91-11-22155684 E: rahul.maini@amoking.com W: www.amoking.com

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Servomax India Ltd T: +91-40-44436666 E: dharmesh@servomax.net W: www.servomax.net Shashwat Systems Pvt Ltd T: +91-79-65214825 E: sales@shashwatsystems.com W: www.shashwatsystems.com Shiva Analyticals (India) Limited

69

12

39

E: gupta@shivatec-india.com W: www.shivatec-india.com Shree Biocare India T: +91-79-27516630 E: shreebiocare@gmail.com W: www.fermentorsolution.com Shree Siddhivinayak Industries T: +91-22-28458372 E: minivacg@hotmail.com W: www.minivacpumps.com Siemens W: www.siemens.com/pharma Sigmatech Scientific Products T: +91-40-6453 4491 E: sigmatech07@yahoo.com W: www.sigmatech.tradeindia.com Sintex Industries Ltd

23

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BC 101

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T: +91-2764-253500

E: pallets@sintex.co.in W: www.sintex-plastics.com Sintex Industries Ltd

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T: +91-2764-253500

E: csp@sintex.co.in W: www.sintex-plastics.com Sreelakshmi Traders

31

T: +91-44-24343343

E: sreelakshmitraders@gmail.com W: www.sreelakshmitraders.com Sri Vishnu Pumps Manufacturing Co T: +91-22-28458372 E: minivacg@hotmail.com W: www.minivacpumps.com SSP Pvt Limited T: +91-129-4183700 E: info@sspindia.com W: www.sspindia.com Standard Chartered Bank

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T: +91-22-39401616

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E: sme.custoercare@sc.com W: www.standardchartered.co.in Supremo Polymer Industries T: +91-79-22205282 E: supremoproduct@gmail.com W: www.supremoproduct.com Suresh Enterprises T: +91-2762-224814 E: info@sevitsil.com W: www.sevitsil.com Techno Industries T: +91-79-25830742 E: info@technoind.com W: www.technoind.com Thermo Fisher Scientific Sid Divisi

37

E: pradeep.kumar@thermofisher.com W: www.thermofisher.com Waters (India) Private Limited

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13

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T: +91-79-66615344

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Modern Pharmaceuticals

February 2011