COVER STORY

The Changing Contours Of The Biopharma Landscape

The modern era of biotechnology began at the end of the 1970s with the manufacture of therapeutically active proteins by genetic engineering. From molecule to market, biopharmaceutical manufacturing demands mastery of many scientific disciplines and engineering skills. The average cost of drug development has increased over the years, and the cost and time required are even higher for biopharmaceuticals. Because the Indian biopharmaceutical industry does not have the monetary resources to develop novel drugs, it requires financial support or collaboration with other companies. In this context, partnership with foreign companies is probably the best option for Indian companies to take the next step forward on the path of novel drug innovation. India offers multinational drug companies a competitive edge by providing a low cost base in research, clinical development and manufacturing. To attract foreign collaborations, however, there are certain key issues that need to be addressed in India including human resource development, instilling patent culture, infrastructure development, and the simplification of regulations covering research, product approval and intellectual property...
- Dr.Shivraj Dasari, Vice President (Quality Management & Regulatory Affairs) - InnoBio Ventures Sdn. Bhd., Malaysia.

FEATURES

Budget 2010: A Pharma & Biotech Perspective
Presenting the Union Budget 2010-11, the Finance Minister Mr. Pranab Mukherjee, said that three challenges would continue to engage the Indian policy planners for next few years. The first challenge is to quickly revert to the high GDP growth path of 9% and then find the means to cross the double digit growth barrier. The second challenge is to consolidate recent gains in making development more inclusive. The third challenge is to remove weaknesses at different levels of governance and to improve public delivery mechanism. The Budget, therefore, focuses on fiscal consolidation, making growth more broad-based and ensuring that supply-demand imbalances are better managed. The pharma industry sees some benefits with the decision of the finance minister to extend of the R&D tax benefits. This will help Indian pharma companies further focus their R&D. The pharma industry did not see their demands being met except the R&D benefits being extended till 2011 and no increase in customs duty. However, the industry would have greatly benefited if the finance minister would have announced a ten year extension of tax benefits for standalone Research & Development entities and offered incentives to pharma companies for research and annual development in the country...
- Sujay Shetty, Associate Director (Pharmaceuticals / Life Sciences) - PricewaterhouseCoopers, India.

An Overview of Indian and International GxP Guidelines
In the world of pharmaceutical business, quality is defined in terms of GxP (GMP, GCP, GLP, GTP, GDP, etc.). Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made...
- Sachdev Yadav, Reader (Pharmacology) - Rajiv Academy for Pharmacy, India.

Development And Validation Of Cell Based Assays For Cancer Drug Discovery
Cell is composed of hundreds of complex molecules which regulate the pathways necessary for essential cellular functions. From target discovery to clinical trials, cell based functional assays have become very important tool for entire drug discovery process. Specifically in cancer drug discovery, cell-based assays are used to evaluate different cellular aspects like cell surface marker expression, cytokine secretion, activation, signal transduction, viability, proliferation, cytotoxicity, apoptosis and metabolic functions. Such functions are measured by use of numerous assays and technology platforms with wide variety of reagents and instruments. Cell-based assays are inherently variable and require extra care to achieve consistent performance. They are extremely sensitive to changes in the cell culture medium and to various factors including passage number, temperature and the surface on which they are grown to name a few. Regardless of the model system chosen, it is important to establish a consistent and reproducible procedure. The present review highlights the issues related to the development and validation of cell based assay...
- Dr. Maulik Suthar, Lecturer (Biotechnology) - S.K. Patel College of Pharmaceutical Education & Research, India and Prof. Shyamsunder Pancholi, Principal - Babaria Institute of Pharmacy, India.

CORPORATE AFFAIRS

Event Diary
• Pack Plus 2010
• India Chem 2010
• Cphi India 2010
• RDD 2010
• FIP 2010
• ConhIT 2010

Product Trends
• Double Cone, Octagon, V, Cube Blenders
• FA Valve with Gauge and Flow Meter (Fine Adjustment Valve)
• Fully Automatic Liquid Filling Machine
• Planetary Mixer

New Instruments
• Pallsep Biotech Filtration System
• Hiseq™ 2000 Sequencing System

Alliances & Acquisitions
• Perrigo buys PBM Holdings for USD 808 million
• Strides to acquire 100% interest in Oncology JV
• Astrazeneca extends branded generics capability with Torrent agreement
• Roche buys Microarray assets from BioMicro

New Drug Approvals
• Abbott Receives U.S. FDA Approval for New Cataract Multifocal Intraocular Lens
• Aurobindo Pharma receives approval for Cefuroxime Axetil Tablets
• FDA Approves Botox for Spasticity in Flexor Muscles
• FDA Approves First Totally Implanted Hearing System

Launches
• Merix Pharmaceutical Launches OTC Treatment For Genital Herpes
• Lupin Launches Osteoarthritis Drug, Hyalgan
• Perrigo Launches Generic Version of Zaditor™

COVER STORY

India - Dawn of a New Era in Drug Development
Although it typically takes 10 to 12 years and millions of dollars to bring one new drug to market, the success rate is small. In the developing world, no company or institute wants to, or can, invest such time and resources for a marginal improvement in responses over existing therapies. Fortunately, in a majority of cases, clinical trials can provide answers regarding the use or not of a therapeutic agent that can benefit millions of patients worldwide. Being the second most populated country in the world, India can contribute significantly to global drug development programs...
- Dr. Munish Mehra, Managing Director, Global Drug Development Experts, USA.

INTERVIEW

Endress + Hauser Delivers Global Quality Products to Indian Market
Since the year 2000, Aurangabad has been home to the Swiss group Endress+Hauser after they set up their first associated product centre to manufacture flowmeters. The group has expanded the existing facility and inaugurated the new plant to manufacture pressure and level controls. N Sriram, President and Director, Endress+Hauser (India) Automation Instrumentation Pvt Ltd talks about the new centre and its role in the company's overall growth during the years to come...
- N Sriram, President and Director, Endress+Hauser (India) Automation Instrumentation Pvt Ltd.

FEATURES

Working with Investigator Networks in India
India is set to grab clinical trials business valued at approximately US$ 1 billion by 2010, up from US$ 200 million 3 years back, making the subcontinent one of the world’s preferred destinations for clinical trials. Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system...
- Dr. Purvish Parikh, Dr Aparna Parikh, Dr Prabhash Kumar and Dr. Anantbhushan Ranade

Clinical Research:A Strategic Tool for Innovation
India is fast emerging as an attractive destination for global clinical trials. This is because of the availability of a vast pool of patients and also well-trained medical professionals. Many pharmaceutical companies and drug institutes are tapping such talent and making new and affordable medicines that can cure the diseases and ailments in shortest possible time with no or least side effects. The fact that the entire documentation of medicine in India is in English, is an added attraction...
- Dr. Anil Pareek, Head – Medical Affairs & Clinical Research, IPCA.

Challenges In Carrying Out Clinical Trials in India
The foundation of knowledge-based industries in India was laid down by the information technology industry, and there is no reason why clinical research cannot follow in those footsteps. Indian investigators and clinical research professionals have already demonstrated their medical and scientific skills by participating in multiple global clinical trials. It is time now to move forward to capitalize on the opportunity...
- Dr. Pratik Shah, Head - Medical & Clinical Research, Astellas Pharma (India).

CORPORATE AFFAIRS

Event Diary
• CPHI Japan
• US-India BioPharma & Healthcare Summit
• Bio International Convention
• Bangalore India Bio

Product Trends
• Automatic capsule filling machine
• Blister pack machine
• Ceiling suspended laminar airflow
• Nutsche filter

New Instruments
• Whatman Klari-Flex bottle top filtration system
• Millipore launches MilliPROBE Detection System for Mycoplasma

Alliances & Acquisitions
• Siro joins with dreamcis to access korean patient pool
• Biocon explores investment in malaysia in partnership with biotechcorp
• India's indoco, us' watson pharma in drug deal
• Angel biotechnology to provide consultancy services for fusion ip's latest spin-out progenteq

New Drug Approvals
• Pfizer Gets European OK for Intravenous Revatio Sagent Pharmaceuticals Announces FDA Approval Of Labetalol Hydrochloride Injection, USP
• Pfizer Gets European OK for Intravenous Revatio FDA Approves New Lidocaine-Containing Dermal Filler Formulation
• Pfizer Gets European OK for Intravenous Revatio Amneal Receives FDA Approval For Tramadol/APAP Tablets
• Pfizer Gets European OK for Intravenous Revatio FDA Approves Xiaflex For Debilitating Hand Condition

Launches
• Daiichi Sankyo to Launch Innovator Products in Mexico through Ranbaxy
• NSF Grant To Launch World's First Open-Source Genetic Parts Production Facility
• GSK Launches New Specialist Unit To Research And Develop Medicines For Rare Diseases

COVER STORY

Mr Huzaifa Khorakiwala: The New Age CEO
Mr Huzaifa Khorakiwala, the eldest son of Mr. Habil Khorakiwala (Founder & Executive Chairman - Wockhardt Ltd), is waging a different war unlike other business scions. In spite of his full time role as the Executive Director of Wockhardt Ltd, the young and inspired social entrepreneur has mounted a long drawn campaign against some of the most debilitating public health maladies and social ills plaguing the country through his unique NGO - Wockhardt Foundation. The Foundation plans to raise 50 crores by the end of 2011 to support the 10 major social initiatives undertaken by its volunteers (warriors) for the upliftment of socially and economically underprivileged sections of the society...
- Mr Huzaifa Khorakiwala, CEO (Wockhardt Foundation) & Executive Director (Wockhardt Ltd.)

INTERVIEW

"The Blockbuster Model is Outdated"
Recent developments clearly indicate that the pharmaceutical industry has to undergo a major transformation in the days ahead. There is an urgent need to look beyond today's business. This calls for evaluation of diverse businesses and effective business models and analyse the findings to think about the future of the pharmaceutical industry. The pharmaceutical industry in India has enviable strengths in cost effective research and quality manufacturing. Interlink's Dr. Raja B. Smarta, a veteran of the pharma industry exhorts Indian companies to revisit their plans and invest in new initiatives of growth. He charts out the strategy and action plan for the Indian pharma industry in a detailed interview session with Thomas Antony...
- Dr. Raja B. Smarta (Founder & Managing Director), Interlink

FEATURES

Efficiently Incorporating GCPs and GLPs in Pharmaceutical Research
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory...
- Dr. Bhaswat S. Chakraborty (Sr. Vice President, R&D), Cadila Pharmaceuticals

A View from Abroad: Clinical Trials and Patents in Europe
A patent gives the owner the right to prevent others from making, using, selling, offering to sell, or importing the claimed subject matter during the life of the patent (usually between about 17 and 20 years). The patent holder owning rights to a basic element of a technology can command all applications of that technology by forcing parties developing the applications to acquire licenses from the patent holder-if the patent holder wants to grant licenses...
- Markus Engelhard (German and European Patent & Trademark Attorney), Boehmert & Boehmert (Germany)

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive
Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions...
- Stephan Reynier (Project Director), Voisin Consulting (France)

Genetic Testing: A Great Opportunity for CROs
In recent years, much energy has been put into genetic research both through the individual efforts of interested scientists and through the collaboration of international teams in the Human Genome Project. Through this work, we have learned a great deal about how genes function and how they can cause certain problems. We now know how to look for mutations that can lead to specific disorders. Genetic testing is possible for some conditions because we can recognize the difference between a normal gene and a disease gene...
- Sandeep Saxena (Founder & CEO), Acton Biotech

PATENTS: An Effective Tool for Improving ROI in Pharmaceutical Industry
A patent holder can also use the threat of an infringement suit to become the sole provider of a technology or service. Moreover, multiple parties may hold different patent interests in a technology that combines diverse technical elements. Thus, an end-user may require several licenses - and payment of so-called 'stacking royalties' - to use an end product. Furthermore, there is no requirement for a patent holder to actually exercise or license his or her invention. A patent holder can simply use the patent to block any practice of the patented technology...
- Dr. Ute Kilger (German and European Patent & Trademark Attorney), Boehmert & Boehmert (Germany)

CORPORATE AFFAIRS

Event Report
• IDMA completes 48 years
• UBM Sees Significant Rise in Interest in 2009 for Indian Pharma Shows

Product Trends
• Microplate Stacker
• Oxygen Sensors
• Sterility Testing Isolator
• Synthesis Columns

New Instruments
• HISEQ™ 2000 Sequencing System
• Exclusion Chromatography Columns For Proteins
• BD LSRFortessa™ Cell Analyser
• Fast Plate Imager - PLATE RUNNER HD

Alliances & Acquisitions
• AstraZeneca to Buy French Novexel in $505 Million Deal
• Novartis Signs $220 Million Hearing Pact with GenVec
• Compugen Signs Development Deal With Pfizer
• Sanofi-Aventis to Buy Chattem in $1.9 Billion Deal

New Drug Approvals
• Pfizer Gets European OK for Intravenous Revatio
• FDA Approves Actemra for Rheumatoid Arthritis Treatment
• Abbott's XIENCE V® Approved in Japan - Second Largest Drug Eluting Stent Market Worldwide
• FDA Approves Ampyra To Improve Walking In Adults With Multiple Sclerosis

Launches
• Novartis Launches Schizophrenia Treatment FANAPT In The US
• Ranbaxy Launches Dermatological Product 'LULIFIN'
• Agilent Technologies Launches One-Step Setup RT-PCR Kit
• Natco To Launch Cancer Drug As Min Stays DCGI Order

COVER STORY

Pharmaceutical R&D - Past, Present And Future
Indian pharmaceutical industry was non existent at the time of independence. India was a net foreign exchange loser. The medicines in India were expensive and available after a significant time lag of launch in Europe. Availability of medicines was restricted to few centers in India. Patent rules were old and in line with the British rules. Pharmaceutical industry was regulated by medical professionals (civil surgeons). The journey till now has been turbulent but extraordinary making India self-reliant and provider of affordable medicines to the world. This has been achieved by research and development activities by pharmaceutical industry. These activities were helped by policies and regulations framed by Government of India and state governments. The administrators / regulators fuelled the growth by implementing the policies and regulations in a proactive, industry friendly approach...
- I. A. Modi, Chairman, Cadila Pharmaceuticals Ltd.

FEATURES

Novel Bioadhesive Formulations for Improvement in Therapy
Bioadhesion is the state in which two materials, at least one of which is biological in nature, are held together for extended periods of time by interfacial forces. Prolonged contact time of a drug with a body tissue, through the use of a bioadhesive polymer, can significantly improve the performance of many drugs. These improvements range from better treatment of local pathologies to improved drug bioavailability and controlled release to enhanced patient compliance. There are abundant examples in the literature over the past 15 years of these improvements using first generation or off-the-shelf bioadhesive polymers.The present mini-review will remind us of the success achieved with these bioadhesive polymers and focus on proposals for the next-generation polymers and attendant benefits likely to occur with these improved polymeric systems...
- Bhupendra G. Prajapati, Dr. Madhabhai Patel

Amino Acid Analysis by Capillary Electrophoresis from a Nutraceutical Formulation
The analysis of free amino acids and their enantiomers and derivatives by Capillary Electrophoresis has become an increasingly active area of research, particularly for small sample volumes where high resolution is required. In food and nutraceutical products free amino acids can be important nutrients, flavourants, flavour precursors and indicators of protein composition. Since most amino acids lack a strong chromophore for detection, the determination of amino acids by CE is usually achieved with the aid of derivatization with a suitable chromophore or fluorophore. This derivatization step restricts the CE method to use of specific buffer system whereby the flexibility of CE technique is lost. In the present research amino acids are detected without derivatization where by the method is more flexible...
- Kavita Kandari, Mamta Jadhav, Dr. Sasikumar Menon

Spectrophotometric Determination of Lamotrigine in Dosage Forms
A simple sensitive spectrophotometric method in ultraviolet region has been developed for the determination of Lamotrigine in bulk and dosage form. Lamotrigine shows maximum absorbance at 285 nm with apparent molar absorptivity of 1.902 x 104 l/mol. cm. Beer's Law was observed in the concentration range of 2.5 - 25 µg/ml. The method was statistically evaluated for accuracy and precision.
- R. K. Sharma, Salem A. Aboaisha

CORPORATE AFFAIRS

EVENTS
• Pharma & Biotech Supply Chain Management World Asia
• The 7th Annual BIO Asia Partnering Conference
• Advancing Biologics from the Lab to the Clinic
• Pharmacovigilance 2010
• BioAsia 2010

PRODUCT TRENDS
• High Voltage Leak Detector Type HLVD 924
• Ocillating Granulator
• Double Beam - X-Ray Inspection Machine
• Needle Destroyer
• Fixed Volume Microlitre Pipettes
• Tray Dryer
• Plasma Freezers

NEW INSTRUMENTS
• New Cancer Research Tool: Roche's CIM-Plate 16
• Gene-Testing Machine for Doctors
• BRANDplates Immunoassay plates
• GE Healthcare launches FTA DMPK sample cards
• Cartridge Heaters suit life science and biotech applications
• Pump Tubing brings security to harsh chemical processes

ALLIANCES & ACQUISITIONS
• Biotek Instruments and Millipore Collaborate on Application Note for Hormone Assay Panel
• Lonza Acquires Stake In Cilian AG
• Pfizer and Flamel Technologies sign license agreement
• Novavax and Xcellerex Announce Collaboration to Develop Large-scale Manufacturing Process for 2009 H1N1 Influenza VLP Vaccine
• BioGrid partners with Swiss pharma

Cover Story

Manufacturing Success Via Outsourcing
Innovative drugs are the lifeblood of pharmaceutical companies, but the cost of developing them is rising to unsustainable levels. Pharma executives are already saying that as the economy falters, they foresee bleak prospects and mergers unless their companies get more innovative drugs into their pipelines. The clock is ticking on the race to increase productivity, as key patents worth a projected $30 billion in revenue will expire between 2010 and 2013, opening the floodgates to competition from generics. This imperative is propelling increased outsourcing as companies trim overcapacity. Do we see a new paradigm in pharmaceutical manufacturing?...

INTERVIEW

"Almost every industry is looking at nano particles"
Malvern's range of instruments encompasses measurement of particle size, particle shape, zeta potential, molecular weight, molecular conformation, solution viscosity, chemical composition, and rheological properties. The company's innovative technologies combined with intelligent, user-friendly software deliver industrially relevant data to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging). Mr. Stuart Wakefield - Director, Malvern AIMIL Instruments Ltd, elaborates on the significant role played by Malvern's sophisticated instruments deployed in pharma / biotech industries worldwide...
- Stuart Wakefield

FEATURES

Sampling and Dispersion - The keys to accurate particle size analysis in pharmaceutical materials
Particle size analysis using laser diffraction measurement may now be considered routine, but one aspect remains poorly understood - the need for good sample preparation. This paper examines the requirements for good powder sampling and dispersion, for both laboratory-based laser diffraction measurements and when measuring on-line, in real time, within the process environment. The methods available for representative sample extraction from a process stream and techniques that ensure powder is dispersed effectively without affecting the measured primary particle size are also elucidated...
- David Pugh, Paul Kippax

Scope of Software Solutions in Helping the Pharmaceutical Industry Achieve Operational Excellence
IT executives know that the right investments in technology can deliver a significant competitive advantage. Taking a leaf from the success stories in other industries the CIOs in the pharmaceutical industry have an opportunity to become true pioneers...
- Mangesh Panditrao

Understanding the Importance of Photostability in Pharmaceutical Products
The photostability of drugs represents an important field in pharmaceutical research and a high number of compounds have been discovered to be photolabile. A complete knowledge of the drug photo-reactivity is effectively essential for a correct pharmaceutical formulation and its packaging. A protocol for testing the photostability of new drugs is described in the ICH Guidelines and recommended in the pharmaceutical industry as a key test...
- Dr. Naresh Tongay

CORPORATE AFFAIRS

EVENTS
• BIO India 2010
• Pharmaceutical Expo
• Late Phase Drug Development World 2009
• CPHI India 2009
• The analytical science and regulation of pharmaceutical packaging
• Biologic Manufacturing World Asia 2010

PRODUCT TRENDS
• Spray Dryer For The Pharmaceutical Industry
• SIFT-N-BLEND™- Powder Blender
• Powder Tester: FT4 Powder Rheometer
• Diverter D4
• Pinhole Inspector
• Oral Liquid/ Ointment Manufacturing Plant
• Automatic Four Head Vial PP / Flipp-Off Capping Machine

NEW INSTRUMENTS
• 3-in-1 lab-scale tablet coating system
• Aseptic Quick Disconnect Couplings
• FSX100 all-in-one microscope system
• Class II Biological Safety Cabinets
• 310 Genetic Analyzer
• Biocontainers
• First UV Resistant Clear PVC Piping

ALLIANCES & ACQUISITIONS
• Sanofi-Aventis and Micromet to Develop New Tumour Antibody
• Tianyin Pharma Forms JV to Expand Antibiotics Business
• Eurogentec Announces Agreement to Acquire Anaspec, Inc
• Kinaxo Diversifies In Therapeutics
• Oncodesign moves forward with Sanofi-Aventis

Cover Story

Pharma machinery sector doing well
The Indian pharma industry was dominated by imported machines during the sixties and seventies. The move from being an import-dependent sector to indigenous engineering companies received an impetus due to foreign exchange shortages. The government imposed heavy import duties and restrictive import licensing policies which turned out to be a blessing in disguise, because that brought to the fore India’s own engineering minds who soon started making pharma machinery at much more cost effective rates. In value terms, there are more machines being imported today than exported. but in terms of quantity, it is reverse This is because imported machines are more than seven to eight times the value of the Indian machines. We still do not make machines requiring high technology and also lab equipment required for R&D labs, therefore we still need to import these machines...

INTERVIEW

"It is unfair to compare Chinese SEZs with Indian SEZs"
The 36 year old Ajanta Pharma Ltd has an envious history of spotting new business opportunities. It was one of the few pioneering Indian pharma companies to focus on exports. The company is now all set to replicate the same success story in the infrastructure sector with its group company, Inspira Infrastructure Ltd. Mr. Ravi Agarwal � Director, gives us more details about their pharma & biotech SEZ at Aurangabad apart from highlighting the significant role of SEZs in promoting pharma exports...
- Ravi Agrawal

FEATURES

Use of Wireless Technology in a GMP Environment
With the advent of new technologies in the wireless domain from the beginning of this decade, there are several instrumentation and measurement applications, which can beneficially exploit this technology. While there are still some challenges with respect to the application of wireless communication to the large scale control & automation in a complex process control environment, there are many applications within the industry where it is very much worthwhile to introduce this new technology. The author has tried to provide a simple approach to complete wireless applications in a GMP environment (drug manufacturing & Biotech ). The article is particularly aimed at companies who are planning to use wireless technology for their GMP environment, and would like a quick review on how to approach the decision-making process...
- Niraj Vinaik

How Indian CROs can propel themselves into the big league?
The Indian CRO market is currently at a turning point wherein a miniscule and insignificant $ 300 Mn industry has the potential to transform itself into a $1 Bn plus powerhouse with significant stake in the development of potential global pharma blockbusters. This article deals with how Indian CROs can propel themselves into the big league in the coming years just as relatively unknown Indian IT companies achieved the same a decade back by applying the right strategic levers. The article provides an overview of the global CRO industry as well as how the Indian CRO market has evolved. It next elaborates Ten Strategic Levers that Indian CROs can leverage to achieve scale. These include Full Service CRO Offerings, Deep Therapeutic Expertise in 3-4 Key Therapeutic Domains, Robust Consulting Expertise, Transnational Sales & Delivery Presence, Global CRO Partnerships & Strategic Acquisitions, Strategic Investment Options for Capitalization, Comprehensive Site/ Investigator Network & Site Development Strategy, Access to Robust Patient Pool & Creative Enrolment Strategies and Flexible Commercial & Co-Development Models. It finally concludes with a Vision 2012 for the prominence of the Indian CRO industry...
- Nidhi Saxena

Recent Techniques For Oral Time Controlled Pulsatile Technology
Pulsatile drug delivery systems are gaining a lot of interest and attention these days. These systems have a peculiar mechanism of delivering the drug rapidly and completely after a �lag time,� i.e., a period of �no drug release.� Though most delivery systems are designed for constant drug release over a prolonged period of time, pulsatile delivery systems are characterized by a programmed drug release, as constant blood levels of a drug may not always be desirable. Pulsatile systems are designed in a manner that the drug is available at the site of action at the right time in the right amount. These systems are beneficial for drugs having high first-pass effect; drugs administered for diseases that follow chronopharmacological behaviour; drugs having specific absorption site in GIT, targeting to colon; and cases where night time dosing is required...
- Bhupendra G. Prajapati, Himanshu Solanki

CORPORATE AFFAIRS

EVENTS
• Pharmac India 2009
• 61st Indian Pharmaceutical Congress 2009
• BioAsia 2010: The Global BioBusiness Forum
• CPhI India 2009
BIT Life Science's 2nd Annual Congress & Expo of Molecular Diagnostics 2009 (CEMD)
• Biotech 2009

PRODUCT TRENDS
• Pure Steam Generator
• Capsule Loader Machine
• Sponge Silicone Gaskets
• Roll Compactor
• Paste Kattle

NEW INSTRUMENTS
• Mobius® CellReady(TM) 3L Bioreactor
• CyAn Flow Cytometer packaged with HyperCyt System
• FT-IR For On-site Material Identification
• 'Virtual Microscope' System
• RamanRXN2TM Hybrid Analyzer

ALLIANCES & ACQUISITIONS
• Cytopia Union with Toronto-based YM BioSciences Inc.
• BIOBASE And CLC bio Partner to Give Genomics Researchers World Class Solution
• Sanofi-aventis and Merrimack Pharmaceuticals Enter Into a Worldwide Collaboration and Licensing Agreement on MM-121, an Anti-ErbB3 Monoclonal Antibody
• Galapagos achieves first milestone in anti-infectives coalition with GlaxoSmithKline
• Genentech licenses SurModics tech for SR Lucentis

Cover Story

Barriers For Thermoformed Blisters
As convenience and compliance concerns provoke interest in unit-dose packaging, film developers and converters have responded with continuous innovation in blister materials and packaging systems. Blister sealing is one of the basic, yet critical fundamentals that pharmaceutical companies count on from their contract packagers. Consistently and continually delivering compliant, safe, successful blister sealing builds trust and provides the confidence needed in a partnership between a contract packager and pharmaceutical company.....
- Dr. Erwin Pasbrig

Packaging of Pharmaceuticals
Packaging is a multidisciplinary discipline that incorporates elements of engineering, chemistry, biology and business. Packaging interacts with all elements of the supply system necessary to deliver products to consumers in a safe, high quality, sustainable state. It involves materials selection, package design, production, distribution and marketing based on consumer needs and desires. Over the past 15 to 20 years, the traditional roles of packaging as a protector and an ensurer of product quality have broadened into a multi-disciplinary dimension including brand differentiation and a guarantor of trust amongst consumers. It is a key element in the safe delivery of high quality products in the global supply chain. It helps maintain shelf life for perishables and is vital for the secure delivery of products. It can help protect the product from the environment or protect the environment from the product. But it can also do so much more...
- Mr. Jitendra B. Dave

Emerging Trends in Bottling Line Technology
For years bottle packaging lines have been designed with an emphasis on line speed vs. overall equipment efficiency (OEE) and return on investment (ROI). Enormous lot sizes of blockbuster drugs are no longer in the pipeline for most pharmaceutical companies. The days of running 1 or 2 products on a line at 300+ bottles per minute (bpm), with changeover occurring only a few times per month have passed and given way to the more efficient and ultra flexible lines that are now available...

FEATURES

India - The New Medical Devices R&D Capital
The global medical device industry is valued at US $206.59 bn (2008) i.e. - 30% of the world pharmaceutical market, at a CAGR of 10%+, it is growing much faster than its drug counterpart. With over a 1000+ medical device players globally and all top 30 device companies posting healthy double-digit gains over the prior fiscal year, it is a booming industry. Valued at roughly $ 1.15 Bn, the Indian market for medical equipment, devices and supplies ranks among the world's Top Twenty. Further, given the phenomenal engineering and medical talent available in India, it is being seen as a global hub for end-to-end product development i.e. from concept generation through industrial design, prototyping, pilot manufacturing, in-vitro and clinical testing. Also, medical device regulations have undergone considerable change and a number of new medical devices were added to the Drugs and Cosmetics Act in October 2005 bringing them into the purview of regulatory control. New guidelines for sterile medical devices came into force on 1st March 2006 and the DCGI is still iterating its guidelines on Medical Devices Registration and Trials. All this has been conducive to the growing trend of medical device design and development from India and offers a significant opportunity for product R&D companies and CROs alike....

CORPORATE AFFAIRS

EVENTS
• Bioph 2009
• Pharma Force 2009
• BIOTECHNICA 2009
• Biotech Forum + Scanlab
• PHARMACY St. Petersburg

PRODUCT TRENDS
• High Vacuum Oil-Seal, Rotary Pumps
• Pneumatically-operated Valves
• Safety Relief Valves
• Centrifugal Pumps
• Sanitary SS Centrifugal Pumps

NEW INSTRUMENTS
• Cellavista System
• New 1 mL 96-Channel Pipetting Head
• High-Throughput Analysis Using the Novel LightCycler� 1536 Real-Time PCR System
• MPS-1000 centrifuge
• Electronic pipettors

ALLIANCES & ACQUISITIONS
• Abbott to Collaborate With Pfizer Inc on Companion Diagnostic Test
• Judge: Elan's J&J deal breached Tysabri partnership
• Procter in $3.1bn drug unit sale
• Facet Biotech and Trubion Pharmaceuticals Inc.Announce Worldwide Collaboration
• Orexo AB Signs Exclusive Worldwide License Agreement for a Novel Formulation with Novartis Corporation Affiliate

Cover Story

Green Prescriptions for the Pharma/Biotech Industry
Unlike other sectors, the pharmaceutical industry must comply with stringent current good manufacturing practice regulations. Decisions about green, sustainable, and energy-saving opportunities cannot be based on financial considerations alone. It is imperative that all systems, processes, equipment, and facility designs be reliable and not compromise drug efficacy and safety. Being green in the pharmaceutical industry begins at the intersection of business, innovation, compliance, and the environment....

INTERVIEW

"Eliminating contamination is our DNA!"
For more than three decades Klenzaids has been working in the field of aseptic technologies providing engineering services that minimize and control contamination in the pharmaceutical / biotech industry. Mr. Chandru Shahani, Founder Chairman, Klenzaids tells us more about his long journey and the various milestones crossed by his company...
- Mr. Chandru Shahani, Founder Chairman, Klenzaids

FEATURES

Reduction of waste water in pure water generation in the pharmaceutical industry
Water, the elixir of life - a term most apt to the pharmaceutical industry for which the quality of water is critical and receives high priority. Water is an essential ingredient of pharmaceutical preparations and is used primarily for manufacture of oral preparations and in injectibles and intravenous fluids, besides washing of ampoules and bottles. The process of production of pharmaceutical grade water has evolved over time, with many upgradations in quality specifications and production methods. Non-chemical processes and greater levels of automation are fast becoming the order of the day. U.S. and Europe pharmacopeia standards specify not only the quality of water to be used but also the method to produce the water. Although the Indian pharmacopeia is based on British pharmacopeia standards, several pharma companies have also started following the United States Pharmacopeia (USP) standards as the Indian pharmaceutical industry gears up to compete in a fast growing and very demanding global market...

Pre-Filled Syringes: A New Concept
The administration of therapeutic drugs via injection is an indispensable delivery method for numerous drugs critical to patient health and well-being. Now this segment is evolving in response to changing patient populations, new classes of powerful therapeutic drugs and healthcare administration initiatives. Population demographics and efforts by managed care providers to control healthcare costs are driving the growth in drug self-administration, particularly for chronic conditions, introducing a new class of na�ve users to parenteral drug delivery. User-friendly syringe and injection device designs and the availability of an increasing number of drugs in pre-filled insertable and disposable cartridges are propelling the growth of prefilled syringes for self-administration...

Design Qualification And Repurchasing Criteria For Pharma Machinery And Equipment
Equipped with latest technology, a slew of high-quality pharmaceutical machineries and equipments, from production to packaging are available in the Indian market. The equipments are available in all sizes for manufacturing of tablets, capsules, ointments and liquid formulations for pharmaceutical industry. In fact, India, over the years, earned the reputation of being a low-cost haven for manufacturing drugs, all thanks to low capital investment on plant and machinery, and cost-efficient man power. One of the effective ways to reduce capital costs and yet be competitive is to use the repurchase option...

CORPORATE AFFAIRS

ALLIANCES & ACQUISITION
• Aurobindo Pharma to buy out Trident Life Sciences
• GSK and Brazil's Fiocruz form partnership for new R&D effort and increased vaccine access
• Synco Bio Partners to Manufacture Versartis Novel Drug for Type 2 Diabetes
• NeuroSearch and Janssen Form CNS Drug Discovery Alliance
• Pfizer and Private Access Announce Plans To Develop Online Community To Accelerate Clinical Research

NEW DRUG APPROVALS
• FDA Approves Extavia
• Zogenix and Astellas Enter Exclusive Co-promotion Agreement in the US for Newly Approved SumavelTM DoseProTM
• FDA Approves Morphine-Naltrexone Combo
• Schering-Plough Gets FDA Approval For SAPHRIS
• FDA Approves GSK's Hib Vaccine, Hiberix®

LAUNCHES
• Agilent Technologies Launches Next-Generation Microplate Labeler for Life Science Laboratories
• Merck eye drug Salutan launched in UK and Spain
• Visen Launches New Annexin-Vivo 750 Fluorescence Molecular Imaging Agent
• Ranbaxy Launches Authorized Generic Version of Rocaltrol(R)
• Genzyme to launch 3 more drugs in India

Cover Story

The Indian Pharmaceutical Industry - Roadmap for Sustainable Growth
The global pharmaceutical industry has been undergoing structural changes where Indian pharmaceutical companies play a key role in this emerging framework. Indian companies have occupied the centre stage of the global pharmaceutical market because of their superior biotech and drug synthesis skills, high quality and vertically integrated manufacturing assets, differentiated business models and significant cost advantages. The Indian pharmaceutical industry is currently the largest amongst the developing nations and one of the flagship sectors of the Indian economy....

FEATURES

Contract Manufacturing of Biologicals - What is in store for India?
An increasing number of global biopharmaceutical companies are outsourcing bio manufacturing (bio outsourcing) to bring their products to market in a cost-effective and timely fashion. This article explores the pros and cons of bio outsourcing and provides some insight into the prospects for future growth of this newly emerging industry both globally and from an Indian perspective...

The Case for Neurology Trials in India
WHO defines health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". With stress levels mounting and secondary to traumatic incidences surfacing globally, neurological disorders are steadily adding onto the global burden of diseases. Alzheimer's, stroke, dementia, epilepsy and Parkinson's disease are some of the well-known diseases determining mortality and morbidity in all societies. A new report from the World Health Organization (WHO) shows that neurological disorders affect upto 1 billion people worldwide with around 6.8 million succumbing to it every year. More worrying is a recent forecast that predicts the number of people affected is set to double every 20 years...

CORPORATE AFFAIRS

ALLIANCES & ACQUISITION
• Icon buys Veeda's UK biomarker lab
• Abbott, GSK Lung Cancer Test Collaboration
• Lundbeck buys Danish biotech firm NeuronIcon
• Vernalis signs Glaxo deal
• Elan to delist in London, stay in Dublin, New York

NEW DRUG APPROVALS
• FDA Approves Livalo for Primary Hypercholesterolemia and Combined Dyslipidemia
• The US FDA approves Lipsovir for marketing and sales in US
• FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes
• FDA Approves Colcrys (colchicine) for Acute Gout, Mediterranean Fever
• FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension

LAUNCHES
• Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Imitrex® Tablets
• American Oriental Bioengineering launches new product for rhinitis and allergies
• Angiotech Pharmaceuticals Announces Launch Of Quill SRS Product Codes For Laparoscopic Gynecology Procedures
• Ranbaxy Launches Generic Losartan In Malaysia
• Lupin to launch more branded generics in US

Cover Story

Conflict and Confidentiality Issues Associated with Outsourcing of Biologics Development to Companies from Asia - an Indian Perspective
The Biologics/Biotech industry is an emerging space in Asia and the industry in India has been making steady progress. With the total global revenue from Biologics closing in on the USD 100 Billion mark and forming a significant component of the USD 1000 Billion global Pharma Market, the relevance of large molecules or Biologics is being recognized. The macroeconomic and microeconomic climates are fuelling changes in the R&D strategies of the Pharmaceutical Industry as it seeks to improve productivity, maximize return on investment and placate investors. In fact the pipelines of most large Pharma companies are now tilting in favour of Biologics. For example, it is estimated that Eli Lilly with the acquisition of Imclone would now have more Biologics in their pipeline than small molecules; similar is the case with Pfizer as it integrates Wyeth, the number of Biologics will start to outnumber the small molecules in the pipeline

FEATURES

Symbiosis of Information Technology (IT) and Healthcare
The last decade has seen a dramatic shift in the healthcare industry, making it an emerging domain globally. In India it is supposed to be the largest domestic market, USD 35 billion industry, and is expected to reach over USD 75 billion by 2012 and USD 150 billion by 2017, according to Technopak Advisors' "India Healthcare Trends 2008" report

A Breakthrough to Ease Coronary Heart Treatment
Lovastatin, a fungal secondary metabolite; inhibits the enzyme 3-hydroxy 3-methylglutaryl Coenzyme A (HMG-CoA) reductase in the biosynthesis of cholesterol. Lovastatin and pravastatin are called as the natural statins which is obtained by fermentation using various filamentous fungi. The lovastatin inhibits HMG-CoA reductase by occupying a portion of HMG-CoA binding site and block the access of the substrate (HMG-CoA) in addition to reducing the risk of cardiovascular morbidity and morality. The HMG-CoA reductase (E.C.1.1.1.3.4) was the first committed enzyme of cholesterol biosynthesis. Coronary heart disease (CHD) is a major cause of morbidity and morality in the present world which is well reduced by the use of statins

CORPORATE AFFAIRS

EVENTS
PackPlus 2009 A preview of the India's 'Total' Packaging Event
Positioned as the complete packaging, processing and supply chain event, PackPlus 2009 will comprise of ten niche shows and four distinct zones. Scheduled from 8 - 11 July, 2009, Pragati Maidan, New Delhi, PackPlus will be spread over 20,000 square meter of space catapulting the event to a new height. Close to 300 companies have already confirmed their participation by May 2009 and the number is expected to hit a total of 400 by June end

ALLIANCES & ACQUISITION
Procter & Gamble and Zirh to Work on Male Grooming Products Together
Cincinnati: P&G has announced its acquisition of the Zirh skincare brand. Zirh is a leading super-premium, male grooming brand available in high-end department stores, specialty outlets and online. Zirh, founded in 1995, enjoys unique positioning as a high-end 'male only' brand and has one of the most comprehensive skin and shave care lines of any male grooming brand on the market today

ACCOLADES & ACHIEVMENTS
Microsoft Announces Winners of the 2009 Pharmaceutical and Life Sciences Innovation Awards
SAN DIEGO : Microsoft Corp. announced winners of the 2009 Microsoft Pharmaceutical and Life Sciences Innovation Awards, honoring companies that have made the most innovative use of Microsoft-based solutions for breakthroughs in business processes and practices throughout the pharmaceutical and life sciences industry

Cover Story

Slow but Steady Indian Pharma Machinery Manufacture Comes of Age
It is significant to note that India and China are making machinery that are 10-20 times less expensive as compared to those made in the US and Europe. Moreover, Indian Pharma machines are also gaining global acceptance.

FEATURES

India - The Diabetes R&D Destination of Choice
Diabetes is a highly prevalent and debilitating disease condition worldwide and is associated with major cardiovascular, renal and blindness related complications leading to several diabetes-induced deaths. According to the World Health Organization (WHO), India is the Diabetes Capital of the world with over 40.9 million Indians suffering from diabetes. More worrying is the alarming rate at which this disease is spreading - diabetes incidence has increased steadily in the last half of this century due to diet, lifestyle and stress-related factors and in the last 30 years alone, the number of urban Indian diabetics has increased by 10 times. This has also led to a rapid increase in diabetes related clinical trials in India. Out of roughly a 1000 trials currently happening in India, approximately 150 i.e. 15% are in Diabetes. This article highlights the seriousness of the disease and opportunity for diabetes research and trials in India with emphasis on the specific challenges faced and emerging responses to the challenges.

End-to-End Integration of HD Devices In The Operating Room Ushers In A New Era In Disruptive Technology
NIR chemical imaging greatly extends the capability of NIR spectroscopy, and is the only PAT-applicable blend monitoring technique that gives both statistical and direct information about individual sample components on the micro scale.

CORPORATE AFFAIRS

ALLIANCES & ACQUISITION
Global Pain Management Plans to Expand its Transdermal Patches and Gels Business to USD 8 Billion in 2012
Nashua, NH : The growing incidence of diseases and conditions related to aging is creating pockets of opportunity for pain management. These opportunities include the expanding use of prescription NSAIDs as second-line therapies for chronic pain and an increase in off-label prescribing. As populations and indications evolve, so too is the pain management sector. Traditionally dominated by tablets and specialty injectables, today's pipeline is heavily represented by pain drugs designed for alternative delivery methods - often generic drugs that possess attractive economic and safety benefits.Responding to the simplified dosing, reduced side effects and relative safety of transdermal pain patches and gels, more than two dozen drug developers - either independently or in partnership - are investing in the clinical development of a diverse range of pain drugs that can be delivered through the skin.

Teikoku Pharma Acquires Travanti Pharma to Develop Transdermal Pharmaceutical Products
California: Teikoku Pharma USA Inc., the international specialty pharmaceutical company, has announced to have acquired effective Minneapolis area-based Travanti Pharma Inc, a privately held corporation that designs, develops and markets innovative drug delivery platforms that improve the safety, compliance, effectiveness and ease of administration of medications delivered to the body

Dr. Reddy receives the American India Foundation - 2009 Award
The American India Foundation (AIF) on 11th May, 2009 honored Chairman, Dr. K Anji Reddy with the prestigious AIF - Annual Spring award. The brainchild of President Clinton, AIF was founded in 2001, and is the leading Indian diaspora Foundation focused on helping underprivileged in India, and is acknowledged as a trusted bridge for Americans to channel their philanthropy toward India

LAUNCHES
Ranbaxy launches clinical trials for anti-malaria drug
MUMBAI: Pharma firm Ranbaxy Laboratories has launched clinical trials for its anti-malaria drug Arterolanc maleate Piperaquine phospahate in three countries including India. In a filing to the Bombay Stock Exchange, the company official said "it has commenced the Phase-III clinical trials for its new anti-malaria combination drug in India, Bangladesh and Thailand

Medtronic's New spinal products to Upgrade Cervical Procedures
Medtronic Inc. has launched two new spinal products in the U.S. market, both of them for cervical procedures. The Vertex Select Reconstruction System Occipitocervical Module is used when spinal conditions require the base of the skull to be fused to the neck. Vertex is an implant system and an instrument set for the procedure

Cover Story

Emerging Opportunities In The Indian Pharmaceutical Industry
Global pharmaceutical companies are increasingly under pressure due to a host of factors, including relatively dry pipeline for new drugs, higher R&D costs and increasing pressure from Governments for reduced healthcare costs. The industry is bracing itself for some fundamental changes in the market place and is looking at newer ways to drive growth. These global trends will have serious implications for domestic pharmaceutical companies. However with the right strategy, Indian companies are very well poised to take advantage of these changes and successfully navigate the future.

FEATURES

Pharma R&D in India - A prognosis
India, known for its inadequate protection to patented molecules, has now emerged as a favoured destination for basic as well as applied scientific research. India offers advantages that few other countries can match-abundant availability of scientific talent, skilled labour, and world-class academic institutions dedicated to science and technology, entrepreneurial culture at globally-competitive costs

Effect of Stress on GnRH and Gonadotropin Secretions
The means by which stress influences reproduction and secretion is not clearly understood, but may involve a number of endocrine, paracrine and neural systems. The impacts of stress on the reproductive axis at the hypothalamus (to affect GnRH secretion) and the pituitary gland (to affect gonadotrophin secretion), with direct effects on the gonads being of less importance. Different stressors have different effects and there are differences in response to short- and long-term stress.
- Ashujit Tagde and Manoj Charde

National Drug Policy & Comparative Analysis
As per the WHO definition, National Drug Policy (NDP) is a group of strategies implemented by the state to reach the objectives it sets in the pharmaceutical sector. It covers both the public as well as the private sector and provides for a commitment to goals, a guide for action to ensure best for the people and most important it provides a common framework
- Sachdev Yadav

CORPORATE AFFAIRS

Adcock Ingram announces intention to acquire Cipla Medpro
Adcock Ingram has announced that it has submitted to the Board of Directors of Cipla Medpro South Africa (Cipla) a notice of its firm intention to make an offer to acquire the entire issued ordinary share capital of Cipla, subject to fulfilment of regulatory and other suspensive conditions, for R2,125bn. This equates to a consideration of approximately R4.75 per Cipla share

Elder Plans Major Push Into The Rs 750 Cr Infection Control Segment
Setting its sight on the fast growing infection control segment, the Rs 5.5. bn Elder Pharmaceuticals Limited has inked a strategic alliance in this sector with M/s Chemische Fabrik Dr. Weigert GmbH & Co. KG, German and European leader in Equipment, services and technologies for infection control related to operating theatres, diagnostics, patient hygiene, patient handling and wound care. Elder is already well established in this segment by virtue of its existing tie-up with Ms Sterisol AB of Sweden. Headquartered in Germany, Dr Weigert is the biggest player in hygiene products in Europe and the world leader in new generation infection control products. Its machine-reprocessing methods for medical instruments and equipment are considered to be the best in the world. Established in 1912, Dr Weigert has presence in over 40 countries across the world

Cadila Pharma - McMaster University of Hamilton Collaborate To launch product to curb sudden cardiac deatht
Cadila Pharmaceuticals, in collaboration with McMaster University of Hamilton, Canada, has announced its plans to launch a product worldwide to bring down cardiovascular morbidity and mortality. The product is a result of an intense research targeted at asymptomatic healthy people. IA Modi, chairman Cadila Pharmaceuticals said, �Worldwide, cardio vascular diseases are the leading cause of death and disability. Despite the best of diagnostic and therapeutic approaches, the challenge to decrease mortality and morbidity stands, because cardiac malfunction does not necessarily happen in patients with symptoms. Various therapies are currently available for secondary prophylaxis of cardiovascular diseases but none for primary prophylaxis. Studies show that cardio vascular death (CVD) burden in developed countries were 5.3 million in the year 1990 whereas in developing countries it was 7-8 million

Cover Story

The Interim Budget - A Disappointment for the Pharmaceutical Industry!
Prime Minister Dr. Manmohan Singh had said that the people of India had sought 'a change in the manner in which this country is run, a change in the national priorities, and a change in the processes and focus of the Government.' The Common Minimum Program of the United Progressive Alliance, built around the 'Aam Aadmi,' was a response to this call for change and the interim budget was in continuation of the same. Increased global competitiveness of Indian enterprise, its resilience to global shocks, and a positive economic outlook has contributed to a marked change in the way the Indian economy is being viewed, within and outside the country

SPOT LIGHT
Innovation In Rural Healthcare
The Arogya Parivar, a Novartis India enterprise, came into being to reach out to the healthcare needs of rural India where even today, poor infrastructure facilities and basic amenities often lead to non diagnosis and no treatment or delayed diagnosis and substandard treatment for even common illnesses. This article is based on the presentation made by Mr. Anuj Pasrija at the Pharma International Conference 2009, organized by the Chemtech Foundation. This initiative is an innovative endeavor to educate the rural masses and to encourage them to visit a qualified physician when unwell, get diagnosed, and then undergo the appropriate treatment
- Mr. Anuj Pasrija

IN FOCUS

PHARMACEUTICAL TECHNOLOGY
Closed - Vial Technology for Aseptic Filling
Aseptic filling has been well established for several decades, but regulatory requirements have become more and more restrictive over time. For example, authorities have requested increased environmental safety in the filling area, with very strict requirements regarding eliminating potential contamination agents and reducing particles, in addition to revising product formulations to eliminate preservatives. These recommendations have led to two major improvements: better air quality control to reduce contamination risk and new container designs
- Bhupendra G. Prajapati, Dipesh Patel, Dr. M. M. Patel

QUALITY MANAGEMENT
Establishing an Enterprise Quality Management System
In today's highly competitive, high velocity, and dynamic business environment, one critical factor that differentiates an organization and gives it an unbeatable competitive edge is the quality of its products, services, and processes. Quality therefore is pretty much a non-negotiable standard. As a Quality Manager in a Clinical Research Organization and a hands-on quality practitioner, the author provides a step-by-step framework for establishing an enterprise wide Quality Management System (QMS) in a CRO and sustaining it through institutionalizing of quality processes, a comprehensive Internal Audit Program and continuous improvement through use of Six Sigma and other quality tools
- Priyadarshini Menon

M&A SPECIAL REPORTS

Merck & Schering-Plough: Rare Example of a Mega-Merger that is greater than the sum of its parts
As a standalone company, Merck & Co. faces a tough future of declining sales. Datamonitor forecasts that the proposed merger with Schering-Plough will succeed in returning Merck to a positive sales growth outlook

SPECIAL FEATURE

Transdermal Drug Delivery - An Overview
Optimum therapeutic outcomes require not only proper drug selection but also effective drug delivery. The human skin is a readily accessible surface for drug delivery. Over the past three decades, developing controlled drug delivery has become increasingly important in the pharmaceutical industry.
- M. Ismil, A. Kader, R. K. Sharma*

CLINICAL RESEARCH

ICMR Guidelines on Clinical Practice
According to the general guidelines of the ICMR, all research involving human subjects should be conducted in accordance with the four basic ethical principles, autonomy or respect for the person or subject, beneficence, non-maleficence, and justice. The guidelines laid down are directed at the application of these basic principles to research involving human subjects. An investigator is the person responsible for the research trial and for protection of the rights, health, and welfare of the subjects recruited for the study. He or she should have the qualification and competence in clinical trial research methods for proper conduct of the trial and should be aware of and comply with all requirements of the study protocol as enumerated under the General Principles and General Issues
- Dr. Sangeeta Aher

Cover Story

Adverse Effects Of Uncontrolled Humidity On Packaging In The Pharma Industry
The Indian drug and pharmaceutical industry is seeing a rapid advancement in technology, and manufacturing processes with a transition from process research to discovering new products. Today, not only has it achieved global recognition as a 'low cost producer of quality bulk drugs and formulations,' leading Indian companies have also established marketing and manufacturing activities in over 60 countries including USA and Western Europe
- Dinesh Gupta, Manoj Bhatia.

SPOT LIGHT
Section 3(d) of the Indian Patents (Amendment) Act, 2005: A Case Perspective
The Patents (Amendment) Act, 2005, brought the Indian patent regime in line with the developed countries world over by amending its laws to meet the requirement of Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the World Trade Organization (WTO). With the enactment of Indian Patents (Amendment) Act, 2005, Section 3(d) came into light. Section 3(d) aims to prevent enhanced patent as well as product life cycle management by the innovator companies, also known as ever-greening of the patent
- Gautam Bakshi, Pooja, and Sukhjeet Singh.

IN FOCUS

LABORATORY TECHNOLOGY
Medica's Equitron Media Preparator - a Boon for any Lab!
With Medica Instrument Manufacturing Company launching its own media preparator under the EQUITRON brand, the stage is set for the company to prove its mettle against international brands and to rule the roost, first on domestic soil and then on foreign lands. Being the first in India to manufacture media preparators for the benefit of their own brethren who have until now been shelling out huge amounts to import such preparators from abroad, the company is doing India proud and setting the right precedent for other Indian companies to become self-reliant as well as globally competitive. Mr. Sachin Shetye, Senior Manager - Technical & Sales, Medica Instrument Mfg. Co., interacting with Pharma Bio World, throws light on the importance of automated media preparators and the advantages that Medica's media preparators have to offer
- Mr. Sachin Shetye.

MANAGEMENT
Evaluating Soft Skills In The Bio-Pharma Sector
Mr. Balram Parath, Country Manager, Bio-Rad India speaks about the importance of soft skills in the bio-pharmaceutical industry. The misconception that soft skills are essential only to the customer-service or hospitality sectors is busted by this interview. It becomes very evident that soft skills are assets for an individual as well as for the organization that he or she belongs to and can go a long way in achieving personal and professional goals
- Mr. Balram Parath.

SPECIAL REPORTS

Pharma World Expo & International Conference 2009.
The Pharma World Expo & International Conference 2009, 24th in the Chemtech series of events, was a grand success with a large number of enthusiastic visitors thronging the exposition and eminent speakers enthralling the audience and leaving them with food for thought. The economic slowdown did not manage to dilute the essence and fervor of the event with most of the dignitaries keeping their word and participating very sportingly

SPECIAL FEATURE

A Patent - an Award for the Inventor and a Reward for the Investor
Short product cycles and increasing competition put enormous pressure on an enterprise to become innovative and to remain competitive in the domestic and export markets. The legal protection of an invention is obtained through the grant of patents. Thus, a patent is an award for the inventor and a reward for the investor. The need for protection of new inventions is not only in the interest of the inventors and owners of the inventions, but also in the interest of the public to promote technological progress. A patent is the grant of a monopoly right to an inventor who has used his skill to invent something new
- Dr. Aher Sangeeta.

CLINICAL RESEARCH

Oncology Trials - The Indian Perspective
Cancer is the challenge of the millennium and billions of dollars are spent each year by pharma, academia, and global governments on research programs focused on finding a cure for this deadly disease. This article discusses various oncology trends as well as the very visible migration of oncology trial activity to India with the challenges and recommendations for the same
- Saleem Khan, Prabha Subramanian.

Cover Story

Innovation - The Lifeline of the Healthcare Industry, especially Pharma
Declining R&D productivity, drying new chemical entities (NCE) pipeline, and a large number of patents expiring are some of the woes of the pharma industry worldwide. With global pharma profits under constant pressure to reduce costs and increase productivity, the government attempting to control the spiraling costs, and more and more generic substitutes being accepted, pharma companies are struggling to find solutions so that they can provide better products at competitive prices, without incurring any losses or jeopardizing their growth
- Dr. Prasad R. Chandragiri

SPOT LIGHT
Medication Errors - Better Safe than Sorry!
The journey from the pen to the patient is a long one and is filled with multiple areas where errors can be made. It has been estimated that for every dollar spent on ambulatory medications, another dollar is spend to treat new health problems by the medications. Tens of thousands of people die each year from errors in their case, and hundreds of thousands suffer or barely escape from non-fatal injuries that a truly high quality care system would largely prevent. Reducing medication errors is a process of continuous quality improvement. Pharmacists are engaged in efforts to improve the quality of the drug use process and to identify ways to reduce medication errors. There is a strong need and necessity to enhance awareness about medication errors and its prevention among pharmacy and other professionals
- Sonal Sekhar M, Asha Jose, Liya Elizabeth Bose, Aneesh T. P., and Dennis Thomas.

IN FOCUS

MARKET ANALYSIS
Economic Meltdown: Can the Indian Pharma Industry withstand it?
As we enter into the New Year, the debate on the impact of global economic recession on the Indian Pharmaceutical Industry continues. Some industry sources believe that the pharma industry is immune to the financial melt down due to its inherent nature of inelastic demand. This sounds as an over-confident stance in facing the mayhem across the world economies
- Supratim Majumdar.

BIOTECHNOLOGY
Innovation in Clinical Research - Personalized Medicine
Is personalized medicine a Hype or an Opportunity? This is a question that still remains to be answered. Personalized medicine is an evolutionary process and involves perfect understanding of the disease and the drug, i.e., the right medicine for the right person at the right dosage regimen. Quite predictably, an individualized guide to proper therapeutic options is needed. Thus, personalized medicine is a form of supplying medication to improve health, based on one's individual needs. The goal is to recognize diseases and what would cure them faster and more effectively
- Dr. Sangeeta Aher.

MANAGEMENT
Negotiation Skills - A Powerful Management Tool!
This article tells what negotiation is all about and how one can improve one's life by negotiating for what one wants. Whenever, the cooperation of another person is needed to do something, howsoever small it may be, negotiation comes into play. Negotiations basically occur when the opposite person has what one desires and one is ready to bargain for it or it is the other way round. Negotiations are everyday occurences, irrespective of who the two negotiating people or parties are
- Mr. Mohan Joshi

SPECIAL REPORTS

The Alkem Story - The Tale of a Living Legend!
How a young Patna University graduate with a simple family background became the head of the major pharmaceutical company in India is Mr. Samprada Singh's unusual story. Mr. Singh, Founder and Chairman of Alkem Laboratories, a Rs. 1000 crore pharma company, would probably say that he owes his success to his initial misfortunes, which he translated into success with entrepreneurial zeal and a positive mental attitude. The company is expected to touch a turnover Rs.1200 crore by March 2009

SPECIAL FEATURE

Indian Regulatory Affairs - Ushering in a New Era
Dr. Surinder Singh, the Drugs Controller General of India, revealed at last year's Pharma Summit that the Indian Regulatory Affairs were undergoing radical changes so as to usher in a new era. This article is based on his presentation at the event. It is indeed extremely encouraging and dispels the myths that the government is not putting in much efforts from its side to support the growth and development of the pharmaceutical and healthcare industry in India
- Dr. Surinder Singh

How to Control SG&A Expenses in a Pharma Company
How to control selling, general, & administrative (SG&A) expenses in a pharma company, is the most often asked or discussed subject in industry circles. How does one control the overheads in a company or how should one measure the productivity of overhead expenses of his or her company? I personally feel that many CEOs have sleepless nights thinking about how to address this issue
- Dr. GBRK Prasad, Dr. Reddy's

CLINICAL RESEARCH

Equipoise and Randomized Clinical Trials - The Debate Continues
It has long been believed that a clinical trial is ethical only if 'equipoise' exists, equipoise being defined as a state of genuine uncertainty on the part of the clinical investigator as to which of the trial arms is likely to benefit the subject
- Dr. Narges Mahaluxmivala

The Art and Science of Recruitment in Clinical Trials
Clinical trials are required to obtain marketing authorization for new products or new indications. Large scale clinical trials that are randomized, double blind, multi-center, and multi-country experiments are commonly used to verify hypotheses regarding the safety and efficacy of a treatment option in a large number of patients, which may need a long time to recruit them [1,2]. Therefore, trials should be designed so as to maximize the number of trial patients in the shortest possible time. A small number of enrolled patients may imply the impossibility of confirming the hypothesis
- Dr. Ashutosh Jani

Cover Story

Document Management - It's all about 'Staying in Control'
Dr. Sangeeta Aher's presentation at the National Conference on Clinical Trials, conducted by the CII in collaboration with ACRO and the Department of Science & Technology, Government of India, focused on the importance of document management control in clinical trials. This comprehensive presentation discussed various document types, their preparation, importance, and control. She emphatically stated that what is not documented is considered as not done; and quite often, essential documents are called 'essential' for nothing
- Dr. Sangeeta Aher

SPOT LIGHT
Global Pharmaceutical Industry - Further Attrition in Growth Rate for 2008, Industry Trends
With an estimated $ 712 billion in sales in 2007, the global pharmaceutical industry was up by 6.5% from 2006. Despite of sales gains being driven largely by price increases, increase in foreign exchange from a weaker dollar, and momentum from a few products introduced in 2006, the overall growth in 2007 was lesser than that of 2006 (7.0% from 2005). However, further attrition in growth rate is expected in 2008 mainly as several products are set to go off patent
- Frost & Sullivan .

IN FOCUS

BIOTECHNOLOGY
Autoimmune Responses: An Attack on Self-Tissues
When the immune system mistakes self-tissues for non-self and mounts an inappropriate attack, the result is an autoimmune disease. Autoimmune diseases can each affect the body in different ways. For instance, the autoimmune reaction is directed against the brain in multiple sclerosis and the gut in Crohn's disease. In other diseases, such as systemic lupus erythematosus (lupus), affected tissues and organs may vary among individuals with the same disease
- Mr. Balram Parath .

STRATEGY
Nurturing young entrepreneurs will create a wellspring of youthful, dynamic leadership
Mr. Samprada Singh believes that although every business venture is basically profit oriented, retaining humanness and lending out a helping hand to those people who had been colleagues once upon a time and chose to move on for independence can eventually prove to be beneficial to both so as to grow together and develop a win-win situation. Respecting the individuality of the dynamic youth and supporting them in their entrepreneurial endeavors can go a long way in promoting industrial growth at large and facilitating healthy competition. Following are his views with regard to nurturing young talent for a better tomorrow
- Mr. Samprada Singh.

SPECIAL REPORTS
Cleanrooms - Going the Clestra Way!
Clestra Cleanroom, a European company with subsidiaries and customers all over the world, designs, fabricates, and installs cleanrooms intended essentially for the pharmaceutical industry. Its strategy is based on the manufacturing of finished partitions and ceiling elements to control the final quality. These elements are adapted to the specific process needs, from the initial design to the installation on site, thus meeting the user requirements and specifications (URS)

Medica Instruments - Instrumental in healthier and higher living
Medica Instrument Mfg. Co., a Mumbai-based manufacturer of medical instruments, is a registered SSI unit since 1967 with the Directorate of Industries and is also an ISO 13485:2003 certified organization. It is also a member of the Indian Pharma Machinery Manufacturers Association (IPMMA). The company's vision is to be a world-class organization in the healthcare industry, excelling in enduring and trusting customer relationships, built out of total customer satisfaction by giving solutions to the existing problems, anticipating future problems, and providing technological backup services on a continual basis to customers

CLINICAL RESEARCH

Cardiac Safety Studies: Thorough QT Studies
This article, based on Dr. Charu Gautam's presentation at the National Conference on Clinical Trials, discusses the need for cardiac safety studies for non cardiac drugs, drug-induced QT prolongation and Torsades de Pointes (TdP), the evolution of the regulatory agency as a response to criticism of delayed TdP-related market withdrawals, and ICH E 14 that insists on using 'Thorough QT/QTc' (TQTS) as a Litmus Test
- Dr. Charu Gautam

Cover Story

Challenges and Opportunities for the Indian Pharma Industry
Following is a report of Mr. Satish Khanna's presentation on the challenges and opportunities for the Indian pharma industry at SCI's Industry Meet conducted in collaboration with Bilcare Research in October 2008. His talk was basically for pharma in general and active pharmaceutical ingredients (APIs) in particular. Comparing the field of pharma to the game of cricket, Mr. Khanna asked the audience if they were aware of how challenging or opportunitive the pharma pitch was
- Mr. Satish Khanna

SPECIAL FEATURE

Competitive Edge through NDDS
Severe competition, the need to maximize revenues, and combating patent expiries are forcing pharmaceutical companies to roll up their sleeves and seek out novel drug delivery systems. It is estimated that NDDS products constitute 17% of the world's pharma market, amounting to $104 billion. Similar trends are visible in India
- Sneha Kadam.

Are the Medical and Pharmaceutical Sciences Working in Tandem?
One knows how difficult it is in modern organizations to achieve cross-functional coordination as well as to optimize the business processes across the functions involved. Decision-making is murked in departmental interests and many a times, suboptimal decisions are taken as compared to global optimal decisions. This leaves one to wonder how best it is to safeguard the customer's interests and excellent companies do go to great length in achieving tradeoffs of various variables involved to see that their organizational interests are protected
- Dr. GBRK Prasad.

IN FOCUS

BIOTECHNOLOGY
Preparation and Evaluation of Glimepiride by Solid Dispersion Techniques using Cyclodextrin Complexes
Solid dispersions of Glimepiride were employed in Hydroxy Propyl Methyl Cellulose (HPMC) and polyvinyl pyrrolidone (PVP) in water-soluble carriers and b Cyclodextrin (bCD), Hydroxy Propyl b Cyclodextrin (HP bCD) as inclusion complexes. Solid dispersions were evaluated by the in vitro method with an objective of enhancing the dissolution rate and dissolution efficiency. The order of increasing dissolution rate observed with various carriers is HP bCD > bCD > PVP > HPMC. HP bCD alone provided an 18.9 fold increase and in the case of bCD, an 11.5 fold increase was seen, whereas water-soluble carriers had 5.2 and 8.48 fold increase in their dissolution rate with PVP and HPMC respectively
- Dr. P. Srinivasa Babu, A. Ramu†, & R.L.C. Sasidhar

PROCESS TECHNOLOGY
Sealing Systems for Pumping Applications
Proper specification and selection of sealing systems for centrifugal pump power frame applications can help sustain the service life of pumps and avoid the need for pump replacement or rebuilds and their associated costs in time and money. Sealing systems have their work cut out for them in pump applications. When a bearing seal in a pump fails, for example, contaminants have an opening to infiltrate both the bearing and the lubricant. Cleanliness of the lubricant will exert a profound effect on bearing service life
- John P. Crawford

PROCESS MANAGEMENT
Enhancing Productivity with Integrated Enterprise
This article focuses on the significance of creating a platform to seamlessly integrate an organization's plant-floor information with its business systems. A convergence of new business drivers, including compressed delivery schedules and ever-pressing regulatory demands, has intensified the focus on the critical value of information generated from the manufacturing environment. This in turn has stepped up the need for manufacturers to create an integrated environment, where plant-floor processes and business systems are managed in a collaborative and synchronized manner
- Mr. Kevin Roach

SPOT LIGHT
New Developments in the Indian Business Environment
At the recently held Indian-Belgian Bio-Pharma Forum, Mr. Prashant Deshpande, in his presentation, discussed the Indian business scenario and the currently changing trends both locally and globally. He spoke about the impact that these developments would eventually have on various sectors at home and worldwide. The present article is based on his informative presentation. "Deloitte" is the brand under which tens of thousands of dedicated professionals in independent firms throughout the world collaborate to provide audit, consulting, financial advisory, risk management, and tax services to selected clients. These firms are members of Deloitte Touche Tohmatsu, a Swiss Verein ('DTT')

COMPANY PROFILE

Rotofilt Engineers Ltd.
Solid/liquid separation is a challenging problem to Process Industries in many ways. It not only eats away profits but also increases efforts to arrive at core requirements by adding more devices and longer routes. It also sometimes leads to a compromise on quality. What seems a minor problem is actually the biggest bottleneck in arriving at optimized moistures in solids and optimized filtrate quality in liquids. The subject solid/liquid separation demands application engineering, based on a case-to-case study, thorough analysis and synthesis, and then arriving at a precise solution, design, and equipment

CLINICAL RESEARCH

Leveraging Cross Border Opportunities: Crams
Dr. Ashutosh Agarwal made a very interesting and educative presentation at the Pharma Summit 2008, organized by the Confederation of Indian Industry. He revealed that opportunities in contract research and manufacturing from across the borders can go a long way in leveraging the capabilities and global positioning of the Indian partner itself and help it to grow vertically as well as laterally so as to gradually convert itself into a global player
- Dr. Ashutosh Agarwal

Cover Story

Conceptual Approach to Pharmaceutical Business
The Indian pharmaceutical industry has proved beyond doubt its capabilities in the world market by its astute manufacturing management and marketing acumen. Following are some of the areas wherein there may exist additional optimization possibilities. However, one should be careful to evaluate the concepts/ideas more in depth and evolve a strategy to suit one's own company's requirements
- Dr. GBRK Prasad

IN FOCUS

TECHNOLOGY
Need and Development of Directly Compressible Co-processed Excipients
Tablets and capsules are the most preferred dosage forms of pharmaceutical scientists because they can be accurately dosed and provide good patient compliance, they are easy for companies to manufacture and they can be produced at a relatively low cost. The simplicity and cost-effectiveness of the direct-compression technology have positioned as an attractive alternative to traditional granulation technologies (wet granulation & dry granulation)
- Sanjay S. Patel, Natvarlal M. Patel

HEALTHCARE
When a Cardiac Intervention is required - it's not always easy for the patient and the family!
There is an ever-increasing burden of cardiac cases being identified every day. An unfortunate scenario is the affliction of the younger population and more unfortunate is the stress that the family and the patient go through in this unexpected age group of patients
- Dr. Ganesh Kumar

Screening Methods for Gynecological Cancers
Early detection and prompt treatment of early cancer and precancerous conditions provide the best possible protection against the cancer in the individual and the community. Use of the screening tests enumerated help in early detection of cancer and thereby with appropriate treatment, help to reduce morbidity and mortality and reduce the gynecological cancer burden in society
- Sachdev Yadav

SPOT LIGHT

Opportunities In The Indian Medical Equipment Industry
Thanks to globalization, liberalization, and technology, the world is shrinking and mankind is transcending regional boundaries and communication barriers. Workshops, seminars, and conferences, apart from facilitating business ties, can help in developing bonds of friendship between countries. This can go a long way in creating mutually beneficial opportunities to spell success
- Dr. Prasad R. Chandragiri

SPECIAL FEATURE

Medico-legal aspects of a Clinical Laboratory
Dr. Thuppil Venkatesh, Principal Advisor of the Quality Council of India, delivered a memorable lecture as he made his presentation on the medicolegal aspects of a clinical laboratory at the 5th Annual Quality Control Meet on Quality Awareness conducted by the Quality Council of India in collaboration with Bio-Rad Laboratories in September 2008
- Dr. Thuppil Venkatesh

Lean Six Sigma in Quality Management: Myth or Muda?
Dr. Richard Pang, at the 5th Annual Quality Control Meet on Quality Awareness organized by the Quality Council of India and Bio-Rad Laboratories in September 2008, made a very informative presentation on Six Sigma, something that is attracting a lot of attention these days but not many are aware about its intricacies. This article is based on his presentation and has been deliberately incorporated for the benefit of those readers who were not fortunate enough the grace the occasion by their presence
- Richard Pang

CLINICAL RESERCH

Focus on R&D and the attraction of talent into the country
The Indian Pharmaceutical Industry today is in the front rank of India's science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 9 billion, growing at about 8 to 9 percent annually. Technologically strong and totally self-reliant, the pharmaceutical industry in India has successfully leveraged its cost efficiencies across various aspects of production by virtue of its low R&D costs, innovative and skilled English speaking manpower, strength of national laboratories and an increasing balance of trade
- Mr. Samprada Singh

INTERVIEW

"To aim high and to achieve the same is the main motto of Cheminnova Remedies Private Limited"
Mr. M. Vasudev Rao, Executive Director, Cheminnova Group revealed that the group is setting up a state-of-the-art injectable line in Hyderabad with an investment of Rs. 70 crore. "Cheminnova Remedies Private Limited" is inclined to manufacture lot of new formulations including syrups, suspensions, antacids and also products with an alcohol and narcotic drug base. Apart from this, the company is constructing a dedicated facility to manufacture β-Lactum where staff, executives, workmen, and all others will be maintained separately as per GMP. Following are excerpts from his responses on being interviewed by Sneha Kadam

Cover Story

Wireless Solutions for "Monitoring & Validating Temperature & Humidity in Pharmaceutical facilities"
In accordance with the requirements of Good Manufacturing Practices (GMP) and owing to stringent production & operational norms, the Pharmaceutical & Biotechnology manufacturing sectors in India are adapting to new methods and technologies to comply
- Niraj K Vinaik

IN FOCUS

TECHNOLOGY
Differential Expression and Biomarker Discovery Workflow - a Unique Approach
After the revolutionary initiative in decoding the human genome, the next promising thing is research on proteins. Expression of genes leads to the production of proteins, which are the building blocks of the human body. Hence, the information on proteins has great significance in the current scientific research
- Bio-Rad Laboratories Pvt. Ltd.

Novel Chemical Approaches For Sustained Drug Delivery
In recent years, optimization of drug delivery by means of chemical modifications of known drugs or their analogs has gained interest. So a number of novel chemical approaches were developed for sustained drug delivery that involve careful design of the inactive transport form(s), which are subjected to chemical and/or enzymatic processes, resulting in a rate controlled release of the active drug. The main objective in designing an improved chemical delivery form of a drug should be improvement of its therapeutic index
- Dr. P. Srinivasa Babu*, R. Santosh Kumar, & Bhanu Prasad Kommineni

INTERVIEW

'Promed group aspires to touch a turnover of $ 100 million by 2012-13'
"The company is planning to launch specialized products in India by 2011-12," said Mr. Deepak Bahri in an interview to Sneha Kadam. Following is an excerpt from this interview

SPOT LIGHT

Safety In Automation
New technology and global standards help ensure a safe workplace, boost productivity, and reduce environmental impact. Many of today's legacy-manufacturing systems were developed with either a blind eye or a minimalist approach to safety. Older technology usually forced machines to come to a full stop and be in a "safe state" before repair or maintenance work could be performed
- Dan Hornbeck

SPECIAL FEATURE

Choosing the right combination of pumps, valves, and seals
Choosing the right combination of pumps, valves and seals is a crucial step in the design of fluid motion and control systems for the pharmaceutical and biotech industries. Specifying the proper equipment and ensuring that this equipment works together in an efficient system can yield virtually contamination-free operation in high-purity processes. Coupling the right system of pumps, valves, and seals with highly trained plant personnel will ensure successful operation for applications that demand the highest levels of purity and safety
- Sri Pumps & Fittings Industrial Corporation

Column Selection Guide for HPLC Method Development
High performance liquid chromatography (HPLC) is one of the most powerful and sensitive analytical techniques used today. It is widely understood that all HPLC packings are not alike, and no single column can perform desired separations. HPLC packings differ in hydrophobicity, surface coverage, surface area, pore size, and particle shape. To find the appropriate HPLC column for compounds of interest, start by selecting the molecule size, and then find the appropriate phases based on the application
- Rashmin B. Patel and Mrunali R. Patel

CLINICAL RESERCH

Risk Perception by Subjects of a Clinical Trial - some perspectives
The signing of the informed consent form by a subject of a clinical trial allows the understanding that communication between the subject and the research physician has been adequate and that the subject�s concerns, if any, have been fully addressed. Implicit in this belief is that the risks involved in the clinical study have been discussed and accepted by the subject
- Dr. Narges Mahaluxmivala

CASE STUDY

Solar Water Heating System - Process Application for the Industry A Case Study
Presented here is a success story, the successful installation of solar water heating systems manufactured by M/s Bipin Engineers Pvt. Ltd. at Associate Capsules' factories at Pune and Dahanu. These systems were installed a year back, are functioning satisfactorily, and are giving the desired output, whilst cutting out on the overall electricity consumption and correspondingly saving huge amounts of money for the company
- Associated Capsules Pvt. Ltd.

CLINICAL RESERCH

Dare to dream - to discover, develop, and deliver
The 'Technology Transfer Association' had organized a seminar titled 'Technology Opportunities in Life sciences and Agri-biotech' on 12th September 2008 at World Trade Center, Mumbai. The introductory remarks by its President Mr. Y. H. Gharpure were truly thought provoking and will act as an eye-opener for all those who read his expressed opinions
- Mr. Y. H. Gharpure

Cover Story

System Design for High Purity Water Generation & Distribution
Water quality plays a critical role in the manufacture of pharmaceutical products. Process water is used to compound products, to wash containers, and for steam sterilization. There are two basic grades of water popularly used in the pharmaceutical industry: Purified Water and Water-for-Injection (WFI)
- Gauri Goel

CLINICAL RESEARCH

Public Private Partnerships: Drivers for Growth
Dr. Pradip K. Bhatnagar's presentation at the Public Private Partnerships (PPP) Summit 2008 conducted by Frost & Sullivan on the 4th of July 2008 at the Shangri-la, New Delhi, brought to light India's strengths in research & development along with the productivity challenges in the field, emerging business models, and the need for partnerships and their rewards
- Dr. Pradip K. Bhatnagar

INTERVIEW

The Cleanroom market is expected to grow from €100 million in 2007-08 to about € 120 million in 2008-09
"We are in the unique position to benefit from our past experience and expertise. We provide clients with customized cleanroom and HVAC solutions that not only meet but also exceed their expectations. We are well reputed for our superior service and on-schedule delivery," said Mr. F Schaefer in an interview to Sneha Kadam. Following are excerpts from this exclusive interview

IN FOCUS

TECHNOLOGY
Cleanroom Design in Ten Easy Steps
Although cleanroom designing seems to be a Herculean task with problems apparently cropping up very often, managing these tribulations methodically and systematically can go a long way in improving the functionality of a cleanroom. Stepwise logical solutions are offered in this article to customize the design of a cleanroom as per the needs of the company or industry concerned. Various essential parameters have been taken into consideration to simplify the process of choosing and developing a specific cleanroom
- Vincent A. Sakraida

Formulation and Evaluation of Mucoadhesive Microcapsules of Glipizide with Gum Karaya: Influence of Process Variables
The influence of curing time, concentration of calcium chloride used for curing, method of preparation, and the coat : core ratio on entrapment efficiency and drug release from gum Karaya microcapsules was studied. Glipizide was used as the core and microcapsules were prepared by ionic gelation and emulsification gelation methods. The microcapsules were evaluated for size analysis, drug content, microencapsulation efficiency, and drug release characteristics
- Raparla Rama Krishna, Yarlagadda Ankamma Chowdary, V. Hima Bindu and Talasila Eswara Gopala Krishna Murthy

MARKET ANALYSIS
Indian Laboratory Analytical Instruments Market - On a High Tide!
The Indian laboratory analytical instruments market is characterized by strong growth trends driven by the demand from key end user segments such as life sciences and the environment that it caters to. The laboratory analytical instruments market in India witnesses the presence of global leading companies such as Agilent, Waters, Varian, Perkin Elmer, Thermo Fisher, and Shimadzu, to name a few. While these companies dominate the market, certain domestic players such as Chemito, Systronics, Elico, Netel India, etc., have established their pockets of market dominance over the years
- Ms. Deepa Doraiswamy

Pharma retail sector: Shifting gears from unorganized to organized
The Indian pharmaceutical industry is undergoing changes and the pharmaceutical retail sector, which forms a part of this flourishing industry, is no exception. Small time dispensers of medicines, operating out of tiny shops, had traditionally dominated the pharma retailing business in India. As in case of the provisions retailing sector, unorganized players dominate the pharmaceutical retail. However, the pharma retail business in India is coming of age
- Sneha Kadam

HEALTHCARE
Infertility - The Gynecological Perspective
Infertility affects at least one out of every eight couples, but majority of people are still ignorant about this common condition. The commonest myth is that infertility is primarily a female problem whereas the reality is that infertility is no longer regarded as "her" problem. What most people are not aware of is the fact that infertility is a female problem in only 35% of the cases, a male problem in 35% of the cases, a combined problem of the couple in 20% of the cases and is unexplained in 10% of cases
- Dr. Sulochana Gunasheela

SPECIAL FEATURE

Pharmabiotech - The Indian Scenario
India is emerging as a superpower to reckon with. Our multitudinous skilled and dedicated personnel together with advances in technology by virtue of globalization have propelled industrial growth exponentially. India's Pharmaceutical and Biotechnological industries are also booming with India becoming a hub for clinical research, clinical trial outsourcing, contract research, and contract manufacturing of bulk drugs, active pharmaceutical ingredients (APIs), and excipients
- Mr. Anil Mazumdar

SPOT LIGHT

Emerging Role of Excipients in the Pharmaceutical Industry
Novel drug delivery systems are developed to address the challenges of drug development such as bioavailability, permeability, and poor solubility. These demand changes in the conventional use of excipients. The growth of the biotechnology industry, including stem cell therapy, vaccines, and genetic products, also necessitates different drug delivery requirements. Global excipient markets are expected to grow rapidly with the emerging trends in the pharmaceutical industry
- Sonal Sekhar M, Jiny Varghese K, Aneesh T P, Deepa T Vasudaven and Revikumar KG