INTERVIEW

Not a Rosy Road Ahead

Our Strategy for the long-term beyond 2015 is to have a basket of innovative molecules with high market potential. The company has initiated plans to enter new areas that shall fuel its growth beyond2015...
- Glen Saldanha, Chairman & Managing Director Glenmark Pharmaceuticals

Stem cells can be used to grow tissues and organsex vivo for implantation
The most important concerns involved in stem cell therapy are re malignant potential and transmission of disease (viruses)..
- Dr. Gary A Levy, Director, University of Toronto Transplantation Institute

FEATURES

Nanomedicines: Therapies of Ffuture?
In the pharmaceutical industry, 'small' can achieve big and do wonders. Transitioning from 'micro' to 'nano', the innovation-driven industry has proved that small size does hold big promise in future. This article gives an insight of nanomedicines, outlining all issues such as manufacturing, challenges, regulations and applications...
- Dr. Prajakta Dandekar

Orphan Drugs-Nurtured and Fostered
Standing apart from new chemical entities, generics and biologics, is the newly classified orphan drugs grabbing the eyes of Big Pharma, which present a novel reason and challenge for innovation. Experts, from both Pfizer and Glaxo Smithkline (GSK), share their insights and various related issues about orphan drug development, combined with replies from USFDA on regulatory-related queries... - Dr. Deborah Marsden and Dr. Philippe Monteyne

Things to Cconsider Before Buying a Machine Vision System
Machine vision systems act as good detectors of process errors and defects, and ensure good product quality. But, with the availability of a broad variety of these systems, many factors need consideration while purchasing them. This article helps evaluating specific product features and guides through the vision system selection process... - Didier Lacroix

Pharmaco-economics, a well defined tool for improved healthcare management globally
Pharmaco-economics (PE) is effectively applied as a measure for pricing policy in many countries, India too can benefit from its application in the healthcare sector. But the application of Pharmaco-economics can be done only with the support of the government; hence, Government of India has to ensure that they bring in policies to support application of PE. This article throws light on how PE can be used as an effective tool.... - Dr. Gopakumar G Nair

Storage of Data to be on Cloud Nine
Growth in management data coupled with the increasing impetus for cost reduction across the industry poses a unique challenge for most organisations. Some interesting questions which come up are - How can IT departments keep up with the volume of new data (most of which are critical and subject to compliance) and also continue to meet data protection and availability of service levels? How can customers balance these conflicting business drivers?... - Karan Kirpalani

Methods for Site Directed Mutagenesis
Researchers mainly perform mutagenesis to examine gene functions and products and develop mutant strains with useful traits. But the process needs to be site-specific to avoid random mutations. In this article, the author discusses in detail various methods for quick and efficient site-directed mutagenesis... - Dr. Nicola Brookman-Amissah

Wilson Ddisease is Ttreatable if Ddiagnosed Early
Named after the British neurologist Samuel Alexander Kinnier Wilson, Wilson’s Disease (WD) was first described in 1912. WD is characterised by the toxic accumulation of copper (Cu) in liver, brain, cornea and other tissues. It is an inborn error of metabolism. It occurs worldwide with an estimated prevalence of 1 in 50,000 but is perhaps much more common in India... - Dr. Ashish Bavdekar

CORPORATE AFFAIRS

Product Trends
• Thermo Scientific Matrix Amber 2D Barcoded Tubes
• 709-DS Dissolution Apparatus
• Mirrorball: High Sensitivity Cytometry for Cell Based Assays
• DRX-Ascend System
• Seward Stomacher® 400
• Oil Bath Laboratory Instruments
• Laboratory Instruments
• Analytical Electronic Balance
• Visual Colorimeter
• Digi Stable Therm Lab Autoclave

Event Diary
• SPIE BiOS Exhibition
• Bangalore INDIA BIO 2012
• Lab Expo & Conferences Chandigarh
• Pharmapack Bombay
• Pharma Biotech Expo & Conferneces Ahmedabad
• Medical Fair India 2012

INTERVIEW

"We are the First Indian Company to get Multiple Investigational NDAs Cleared by USFDA"

We have been an aspiring company and would continue to look for opportunities that would come on our way as we witness the expiry of many patents...
- IA Modi, Chairman, Cadila Pharmaceuticals Ltd.

FEATURES

Outsourcing: Moving from Cost to Intellectual Arbitrage Companies in Gujarat
The outlook of the people towards outsourcing and sourcing has changed dramatically in the recent years. Although earlier developing technologies would take a long time, now the gap between developing the science and taking it to the market is very less. Knowledge arbitrage has become very important and it is essential to move from cost to intellectual arbitrage, since the technologies which earlier used to stay for about 20 to 25 years, can’t stay now for even 20 months. Based on the presentation of Dr. Prabuddha Ganguli, CEO, Vision-IPR, during Pharma Bio World Expo 2011, this article talks about change in trend from cost arbitrage to intellectual arbitrage...
- Compiled By: Jagan Jacob

Advances and Trends in Biologics Manufacturing Facility Design
Synthesising drugs through bio-route has been a trend increasingly adopted by the pharmaceutical companies. Based on the presentation of Dr. Roshni Dutton, Bio-Process Expert at SNC-Lavalin Pharma, at the Pharma Bio World Conference, 2011, this article discusses in detail the impact of application of advances and trends in biologics manufacturing design on time, energy and product quality...
- Compiled By: Shilpa Vijayaraghavan

Biomarkers: A Breakthrough Paradigm in Diagnostics and Therapeutics
Biomarkers have brought about rapid breakthroughs in diagnostics and therapeutics. Dr. Uma Prabhakar, Consultant, Office of Cancer Nanotechnology Research, NCI-NIH, discusses the importance and developments in the field of biomarkers highlighting the upcoming First Annual Conference on Translational Biomarkers in Diagnostics and Therapeutics, to be conducted by Institute for Strategic Biotechnology, Health and Training (ISBHT), to be held in Mumbai... - Dr. Uma Prabhakar

Optimising Organisational Enterprise through Laboratory Automation
Manual laboratory work can be effectively replaced by automation, which reduces time and energy thus improve product quality and yield. This article deals with important issues related to laboratory automation technology based on the facts of an SLAS survey presented by Dr. Steve Hamilton, Director of Education, Society of Laboratory Automation and Screening (SLAS), during the Pharma Bio World Expo conference 2011... - Compiled By: Shilpa Vijayaraghavan

Smart Camera Vision System: A New Approach to Track and Trace
Spurious and counterfeit drugs have been causing a menace in the pharmaceutical market. As pharmaceutical manufacturers confront increased margin pressure in the coming years, they will look for new ways to lower their costs to install and maintain production lines. Having the option to choose smart camera vision systems instead of being locked into PC-based vision systems at the machine level can be a tremendous advantage that often results in a tracking and tracing solution that’s less-expensive to install, less complex to validate, and less costly to maintain... - Didier Lacroix

Making Cosmetics: New Ways to Cut Batch Times and Save Energy
Most cosmetic products involving emulsions are still produced by applying hot/hot processes. With advanced mixing homogenising and changes in the process, energy can be saved and long cooling times can be reduced up to 50 per cent... - Alexander Lukas

Malaria: An Outbreak Far from Being Over
Asian countries, especially India, have witnessed an overwhelming rise in the cases of malaria, which has created havoc in normal lives of the people. In an exclusive rendezvous with Dr. F D Dastur, a consultant physician at Hinduja Hospital, Mumbai, Pharma Bio World explores and delves deep into malarial disease on why has it led to sleepless nights for the doctors and how can it be eradicated... - Dr. F D Dastur

CORPORATE AFFAIRS

Product Trends
• Rapid Mixer Granulator
• OMAC Sanitary Lobe Pumps
• Digital Pressure Calibrator
• Fluid Bed Dryers, continuous
• Laminar Air Flow
• Capsule Printing Machine
• Industrial Labeling Machines
• Driven Bottom Discharge Centrifuge
• Capsule Filling Machine
• Automatic Capsule Filler, MODEL-A25

Event Diary
• CPhi India Conference Series 2011
• India Lab Expo 2011
• Pharmaceutical Expo 2011
• SPIE BiOS Exhibition
• Lab Expo & Conferences Chandigarh
• Bangalore INDIA BIO 2012

INTERVIEW

"We want to become a Ddiabetes powerhouse in Iindia"

Eli Lilly has been synonymous with Ddiabetes world over, hence its no surprise that more than 60 per cent of the company's sales in India comes from diabetes. Sandeep Gupta, Chairman and Managing Ddirector, Eeli Lilly and Company (India) Ppvt. Ltd. throws light on this and also on topics ranging from why the company is regarded as one of the best companies to work for-to-the recent Lilly-Lupin collaboration...
- Sandeep Gupta, Chairman and Managing Director, Eli Lilly and Company (India) Pvt. Ltd.

"This year we have initiated to put our own setup as 'Ccadmach Europe', which would be based in Ggermany"
More than 80 per cent of the tabletting machines in the various pharma companies in Iindia bear the Cadmach logo. Hhaving more than 30 years experience in servicing its clients, Cadmach is now a market leader in its segment. Iin this exclusive interview Vinit Khambhatta, Executive Director, Cadmach Mmachinery Co Pvt Ltd, shares his insights on the trends in pharma manufacturing and on future plans of the company...
- Vinit Khambhatta, Executive Director, Cadmach Machinery Co. Pvt. Ltd.

FEATURES

HBS Pharma SEZ Ggears up to Ddraw Ttop Pharmaceutical Ccompanies in Ggujarat
"Welcome to the India’s most advanced pharma valley," states its latest tagline with numerous hoardings on NH-8 highway at Panoli, Bharuch, Gujarat. There seems to be a vibrant buzz around the region, as HBS Pharma SEZ gears up to attract pharmaceutical companies to launch their pharma manufacturing units in SEZ...
- Kayvanna Shah

Future of R&D: From Nowhere to Now Here
Sequencing and Microarrays: Friends, not Foes The human genome is comprised of more than three billion base pairs with greater than 99 per cent being identical between any two unrelated people. The remaining one per cent contains a mixture of sequence variants that range in size from a single-base (single nucleotide polymorphisms or SNPs) to indels (insertions/deletions) >1bp - <1kb and copy number variations (CNVs) comprising duplications or deletions greater than 1kb in length1. Many sequence variants have no associated disease phenotype whilst others, which include inherited and de novo changes, can predispose people to diseases such as autoimmune disease², asthma³, schizophrenia⁴, obesity⁵ as well as a variety of cancers^6-8

Ever-changing Business Ddynamics in Pharmaceutical and Ddiagnostic Iindustry
India pharma industry has witnessed multiple transitions right from the MNCs dominating the healthcare scene to the emergence of Indian multinationals like DRL, Ranbaxy, etc. carving their niche in the global markets. Mergers and Acquisitions (M&A) have been dominating the global pharmaceutical industry, Ranbaxy-Daichii and Abott-Piramal being the latest examples. Drive to enhance the size and thereby attaining higher economies of scale has motivated such acquisitions... - Ameera Shah

The Gift of Herbs
Since time immemorial, herbs have been used not only by humans, but also by animals. Anthropologists believe that animals evolved a tendency to seek out bitter plant parts in response to illness. Indigenous healers often claim to have learned by observing that sick animals change their food preferences to nibble at bitter herbs they would normally reject. Hence, we have animals and plants to thank for giving us the gift of herbs. Having said that, even though herbs have been used from ancient times, there are still many things to learn from them, especially about their negative effects...

Morphologi® Gg3S, the Nnext Ggeneration Ccharacterisation System: A Ccase Study
Although the mission of the pollen grains is to fertilise parts of other plants, many a times they never reach their targets. Instead, they enter human noses and throats, triggering allergies in the body. Of all the things that can cause an allergy, pollen is one of the most widespread. But this very pollen grain can be very essential for production of immunotherapy or diagnostic products, as well as in allergy research. This article reviews an automated particle characterisation system, which helps in identifying active allergen source materials being used in the above process...

CORPORATE AFFAIRS

Product Trends
• Automatic Ampoule Making Machine
• Automatic Vials Making Machine (Type R3S)
• Centrifuge
• Dust Extractor
• Multi Column Distillation Plant
• Multi Mill Machine
• Lab Fluid Bed Equipment - Top Spray
• Automatic Ointment/ Cream/ Tooth Paste Manufacturing Plant:
• Capsule Hand Filling Machine 300 Holes

Event Diary
• Translational Biomarkers in Diagnostics and Therapeutics
• Apteka Moscow
• India Lab Expo 2011
• Pharmchina
• My Business India Show
• Pharmaceutical Expo 2011

INTERVIEW

"Pharmaceuticals Segment Represents Our Fastest-Growing Business Globally"

Our primary goal as an eye health company is to be adaptive; we need to meet both unmet patient needs and offer new choices to those patients who want an enhanced level of eye health care... - Rodney Unsworth, President (asia-Pacific), Bausch + Lomb

FEATURES

Moving from Supply-Driven to Demand and Service-Driven Market
The Indian pharmaceutical market has grown at a phenomenal rate over the last couple of years making its presence felt in the international market. With a huge domestic growth potential and an appetite to grab a larger portion of the global market (poised to grow at a compounded annual growth rate [CAGR] of around 6.5 per cent during 2011–2013), Indian companies are looking at automation as the way forward... - Didier Lacroix, Senior Vice President Worldwide Sales & Marketing, Cognex Inc

Regulatory Compliance in Bioequivalence Studies
Compliance to regulations is very important in today’s time, especially in the pharmaceutical sector. The main objectives of regulatory compliance are to ensure safety of subjects and verify the quality and integrity of scientific data. This article deals with the different aspects of regulations when conducting bioequivalence studies... - Dr Kiran Marthak, Director, Veeda Clinical Research

Future of R&D: From Nowhere to Now Here
Research and Development is considered as the backbone of the pharmaceutical industry as it is in the R&D that future blockbuster drugs are born. But, due to a number of irreversible change drivers - the pharmaceutical industry’s current R&D model will have to undergo a dramatic transformation, where organisations will be forced to evolve significantly or abandon traditional approaches in favour of new R&D models...
- Arjun Bedi, Global Managing Director, Health & Life Sciences R&D, Accenture

Adaptive Design: Addressing the Clinical Trial Efficiency Crisis
Over the last decade, pharmaceutical development productivity has dropped remarkably even in the face of rapidly escalating investments. Today, it costs more than fifteen times as much to develop a new product, as it did ten years ago. A leading cause of the industry's disappointing productivity is the traditional approach to development: a linear, sequential series of steps, punctuated by substantial pauses and a high risk of failure that is discovered only after substantial expenditures...

Molecular Diagnostics: Critical Issues for Successful Translation from the Bench to the Clinic
Molecular diagnostics assess a patient’s biological makeup at the genetic level, providing vital information on an individual’s predisposition to develop a particular disease. Unlocking DNA code in this way can also identify treatment options that may be more effective in some patients while ineffective for others. Molecular diagnostic tests can sequence specific regions of DNA to pinpoint genetic mutations or quantify the levels of certain genetic materials which may be expressed by a bacterium, virus or cancer...
- Dr Ilsa Gomez-Curet, Thermo Scientific NanoDrop Products (Wilmington, DE, USA)

MARKET RESEARCH

Mobility Reporting Approach for the Pharma Industry
A leading global pharma company sells different kinds of medicines all over the world. The MR (Medical Representative) plays a vital role in introducing new and promoting existing medicines to doctors, chemists, stockists, etc. The MR also plays an important role in collecting information about competitors' products in the market...
- Neha Surya, Marketing Executive, Aruhat Technologies Pvt Ltd

CORPORATE AFFAIRS

Product Trends
• Pharmaceutical Machinery
• Double Rotary Tablet Presses
• Double Rotary Tablet Press
• Double Cone Blender
• Capsule FillingMachine
• Sifter Machines

Event Diary
• Pharma BioTech 2013
• BioPharm America
• PAC 2011
• Pharmac India 2011
• Pharma Supply Chain Forum 2011
• CPhIIndia 2011 and P Mec India 2011

LEADERSPEAK

Partnerships and Collaborations are the Way of the Future

Novartis has a rich and promising pipeline with 147 projects in clinical development including several very promising medicines for patients with unmet medical need... - Ranjit Shahani, Vice Chairman & Managing Director, Novartis India Limited

Counterfeits: Identifying the Wolf Among Sheeps
The global counterfeit drug industry is estimated to be worth USD 90 billion and causes the death of almost one million people a year, mostly in developing and under developed economies... - Mohan Bhandari, Chairman, Bilcare Limited

Nestor is Engaged in Creating Leading API Capabilities and Formulations
Almost 90 per cent of all the prescriptions worldwide feature the type of formulations that Nestor Pharmaceutical makes. But this isn’t what makes them unique, the fact that makes them stand apart is their mission of producing low-cost, high-quality drugs for many, instead of high priced drugs for the few. In this interview, Rahul Sehgal, President, Nestor Pharmaceuticals, throws light on the growth, philosophy and future strategy of the company... - Rahul Sehgal, President, Nestor Pharmaceuticals

FEATURES

Recombinant Vaccine and Future Trends in Vaccinology
Modern research laboratories, developing future vaccines, exclusively apply molecular biology and recombinant technologies. The so-called 'easy' vaccines, where immune responses against an immunologically stable pathogen are requested, have been developed and are widely used the world over, with a very high success rate. Thanks to such classical vaccines, small pox has been eradicated and according to WHO, polio shall soon follow...
- Reinhard Glueck and Gaurav Gupta

Gastroretention: A Means to Address Regional Variability in Drug Absorption
Controlled release dosage forms have been extensively used to improve therapy with several important drugs due to their considerable therapeutic advantages such as ease of administration, patient compliance and flexibility in formulation over the conventional dosage forms. Absorption windows in the proximal gut can limit the bioavailability of orally administered compounds and can be a major obstacle to the development of controlled release formulations for important drugs. Methods to increase the residence of drug formulations at or above the absorption window are discussed in this review...
- N Kanaka Durga Devi, Y Arun and B Chandra Mohan

Continuous Granulation - Opportunities to Increase Efficiency in Pharmaceutical Production
The process step of particle size enlargement by granulation is often used in the manufacturing of tablets and capsules. This is the most widely-used formulation of current drugs. The efficiency of a traditional batch process can improve considerably if the whole process of tablet manufacturing is converted into a continuous process. Granulation is important here, as this influences the compressibility and the release profile of the drug, as well as the quality of the final product. A method for the continuous granulation can be introduced to allow the user to adapt its existing processes while simultaneously designing new developments that utilise sustainable and robust production technologies...
- Dirk Leister

Emergence of Secondary Market in Pharmaceutical Industry
In the past several years there has been a push to adopt the secondary market by both mainstream end-users and resellers/solutions providers. This has been due to the influx of quality equipment in the secondary marketplace. In this article Romie Castelli, Senior Vice President North American Sales, GoIndustry DoveBid gives insight about the second hand equipment market and its potential...
- Romie Castelii

Strategic Implications of Packaging Choice in the Generic Sector
This paper examines the strategic implications of packaging choice in the generics industry. It looks at how companies are leveraging ultra high barrier thermoform solutions like Aclar® to create new value propositions. Meeting regulatory and quality needs are a given requirement for any primary packaging solution. However, in order to meet the challenges of today’s generics marketplace, innovative generic companies are now looking beyond these basic technical needs and are optimising packaging platform choice to realise market advantage and profitability gains. It is now recognised that pack differentiation offers an ideal opportunity to create a sustainable competitive market advantage...
- David Barker, Charles Rowlands and Amy Morga

Stem Cell Banking: Once in a Lifetime Opportunity to Secure your Health
Stem cell banking is an easy, painless and non-invasive procedure, where stem cells from the umbilical cord are stored or banked to be used in future. It guarantees not only the cure of several life-threatening diseases, but also peace of mind. It is not a very novel concept, but is regarded as a very promising one...
- Dr Prosanto Chowdhury

Role of Contract Research Organisations in Drug Development
With economic pressures, the industry is moving largely to outsourcing to Clinical Research Organisations (CROs) which is advantageous in many ways over the traditional model. CROs have expertise to design, conduct and achieve clinical, regulatory and commercial objective of the trials in a focused manner which is critically important in view of challenges associated with drug development...
- Suneela Thatte

Risk Assessment in Pharma Industry
Pharmaceutical companies face many types of risks every day, including regulatory compliance, product pipeline, intellectual property, product failure, reputation, operational and legal perils. At different times, one or more of these risks seem to take on greater significance...
- Adithya Bhat

Comparative Anaysis of Evaluation Approaches of Applications
The evaluation process of registration applications is started only when all the documents have been filed, registration assessment fee has been remitted and sufficient quantity of drug sample has been submitted for analysis. Apart from being a tedious process, it is also a time consuming one. This article focuses on the differences in evaluation process across different countries. For comparison the authors have taken Australia, Brazil, India, Jordan, Kenya, Malaysia, Singapore, South Africa, Turkey and Ukraine since all the ten countries have very different evaluation approaches...
- Sachdev Yadav and Dr Arjun Patra

Harmonisation of Patent Law is Key in Today's World
The procedure for granting patents, the requirements placed on the patentee, and the extent of the exclusive rights vary widely between countries according to national laws and international agreements. Hence one has to file individual patent applications in all the countries where he wants his patent to be granted. This is where International patent strategy can be of help. This article tries to elaborate, in detail, how this international patent strategy can be managed and what factors are to be taken care of while planning for it as well, as the options available to explore the same...
- Sanjay Patel

Diabetes: Disorder, Not a Disease
Diabetes is a chronic disease that arises when the pancreas does not produce enough insulin or when the body can not effectively use the insulin it produces. Insulin is a hormone made by the pancreas that enables cells to take in glucose from the blood and use it for energy. Failure to produce insulin or when insulin does not act properly or both, leads to raised glucose (Sugar) levels in the blood. This is associated with long term damage to the body and failure to various organ and tissues...
- Dr Ghanashyam Goyal and Dr Mahuya Sikdar

Pros and Cons of the Upcoming Barcoding Regime in India
Track and trace of individual pharmaceutical packages as well as an entire export pallet using high-end barcoding mechanism is now being considered as an important tool in fighting drug counterfeiting in India...
- Didier Lacroix

CORPORATE AFFAIRS

Events Diary
• Medicall
• BioPharm America
• PAC 2011
• Pharmac India 2011
• Pharma Supply Chain Forum 2011
• CPhIIndia 2011& P Mec India 2011

Product Trends
• Spectrophotometer
• Telstar Life Science Solutions
• Pharmaceutical Multi Mill
• Pharmaceutical Freezers
• Rapid Mixture Granulator (trmg-150)
• The Spring & Elevator Factory

INTERVIEW

Avesthagen's innovation-driven, collaborative model enables it to respond rapidly to any change

In this exclusive interview with Pharma Bio World, Dr Villoo Morawala Patell, Founder and Chairperson, Avesthagen Ltd discloses the various factors and strategy adopted by the company that have made a significant impact on its growth and progress in the ever-changing biopharmaceutical industry... - Dr Villoo Morawala Patell

Combating Neurological Diseases with Antibodies
The problem of neurological diseases is perhaps most urgent in India, where there is a particularly rapidly expanding overall and aging population, with 75 million over 60 years including 3.7 million with dementia. The complex and elusive nature of neurological diseases makes understanding mechanisms, diagnosis, treatment, management, and prevention overwhelmingly difficult. Reaching analogous success with the devastating neurodegenerative proteinopathies will continue to require scientists and clinicians alike to band together and sustain the momentum of the immunotherapy... - Dr Lisa Steinh, Director of Business, Imgenex Corporation, San Diego, - Dr Sujay Singh, Ceo, Imgenex Corporation, San Diego And Imgenex India Pvt Ltd

Invoking Immune System, the Saviour Within, to Fight Cancer
NCRM is the first and only institute in India to provide this Autologous Immune Enhancement Therapy (AIET) involving NK Cells and CTLs for patients with cancer. The Biotherapy institute in Japan, the technology providers to NCRM treats almost 10-20 patients every day with an overall efficacy of this treatment more than 20-30 per cent (1). NCRM’s technology uses only the patient’s own plasma for the procedure of cell culture of NK cells and CTLs and it doesn’t employ any feeder layers used in techniques elsewhere, which makes the procedure much safer (2). Dr Samuel J K Abraham, Director, NCRM, Chennai, India and a Faculty at Yamanashi University Hospital, Chuo, Japan, gives us his insight into immunotherapy as a major alternative approach to cancer... - Dr Samuel J K Abraham, Director, Ncrm, Chennai, India And Faculty, Yamanashi University Hospital, Chuo, Japan .

A Peek into Patent Issues in Indian Pharmaceutical Industry
Indian Patent Law has undergone several amendments right from the time it was introduced for the very first time in the year 1856. In the year 1957, Rajadhyaksh Ayyangar Committee reviewed and analysed The Indian Patents & Design Act of 1911 and prepared the report on which Indian Patent Act of 1970 was based. Since 1970, the law has been amended to catalyse the growth of India’s chemical, pharmaceutical & agrochemical industries. The author delves over the issues typically ahead of pharmaceutical industry posed by the system of patenting in India...
- Sanjay Patel, Research Scientist (Ipr), Alembic Pharmaceuticals

Globalisation & Harmonisation of Regulatory Issues: Need of the Hour
An important pre requisite to any harmonised approach to international drug regulation is a firm legal foundation and a well-structured drug regulatory system in each participating country. With mounting economic pressure on the pharmaceutical sector due to trade liberalisation and an increasingly competitive marketplace, regulatory policies need to be harmonised. Simplification, modification, and elimination of country specific requirements are required to achieve effective harmonisation...
- Sachdev Yadav, Assistant Professor (Pharmacology), Department Of Pharmacy Banasthali University Rajasthan - Dr Neelam Chaturvedi, Assistant Professor, Food Sciences And Nutrition, Banasthali University Rajasthan

CORPORATE AFFAIRS

Events Diary
• Meditec Clinika
• Bio Taiwan
• Clinical Lab Expo
• IndiaMART Famdent Show Delhi
• Medicare Africa Expo & Conference
• Healthex

Product Trends
• OCEAN OPTICS SENSORS USP CLASS VI CERTIFIED
• Tecan's New Infinite® M1000 – The Future of Microplate Detection
• Pneumatic Stirrers
• Dual Beam UV-Vis Spectrophotometer

New Instruments
• Biotage's two new Instruments for Sample Preparation
• New Thermo Scientific Heratherm Microbiological Incubators Introduced
• Tecan Sterile Purity Disposable Tips for Freedom EVO® Liquid Handling Arm

Alliances & Acquisitions
• Biotage Announces Research Collaboration with PeptLab
• Thermo Fisher Scientific Acquires TKA
• Lilly & Investor Group Form New Bio-tech Company BioCritica
• Titertek Instruments Joins Forces with Berthold Detection Systems

Launches
• Mylan Plans to Rebrand its India subsidiary as Matrix
• MSN Laboratories' Painkiller 'Tapentadol' Launched
• Sanofi-Pasteur Aims to Launch Dengue Vaccine in 2014

FEATURES

Harnessing Life Science Industry Growth

Ranjit Shahani, Vice Chairman & Managing Director, Novartis India Ltd., in his key note During the time of economic meltdown, when the global industry was largely challenged and most of the companies were either collapsing or retracting, Aspen Technologies believed it to be the best time to show their commitment towards their existing customers and extend services to the new ones. In the words of Jamie Hintlian, Vice President and Managing Director, Aspen Technology, India is one of the key focus areas where AspenTech will be increasing its presence. During his India visit, he talked to Pharma Bio World coining that bio-pharma solutions from their group would enable the industry to follow a more structured scale-up, increase productivity and reduce costs... - Jamie Hintlian, Vice President & MD, Pharmaceutical Business Unit Aspen Technology, India.

Novel Biomarkers of Diabetic Nephropathy
Type 2 diabetes (T2DM) is the major cause of end-stage renal disease. It is projected that T2DM is the primary cause leading to kidney disease in 20-40 per cent of people starting dialysis. Presently this disease is not recognised early enough because of insufficient diagnostic methods. Novel, more sensitive biomarkers may be used to recognise diabetic nephropathy at an early stage, and possibly also detect disease progression or regression after drug therapy. All of the biomarkers talked about are available or under development at Pacific Biomarkers, Inc...

Diagnostic Industry - Trends, Opportunities & Challenges
The current scenario presents ample of opportunities for diagnostic industry to collaborate with pharmaceutical industry so as to offer attractive package deal to the patients. This will not only benefit both the industries, but will also help the wellbeing of the end customer - the patient. Ameera Shah, CEO & Managing Director of Metropolis Healthcare Ltd, reviews the trends, opportunities and key drivers of the industry... - Ameera Shah, CEO & Managing Director Metropolis Healthcare Ltd.

Growing Need for Pharmaceutical Patent Professionals
The domestic pharmaceutical market is likely to grow to USD 20 billion by 2015, to become one of the leading pharmaceutical markets in the next decade. Patent-protected products have the potential to capture up to 15 per cent share of the total market by 2015, implying a market size of USD 3 billion. Hence the need to protect the knowledge from unlawful use has become expedient. Dr Deepa K Tiku, Programme Director, Global Institute of Intellectual Property and Atulya Nath, CEO, Global Institute of Intellectual Property, give an insight into why the pharmaceutical industry needs more and more of Patent Professionals...
- Atulya Nath, CEO & Dr Deepa K Tiku, Prpgramme Director, Global Institute Of Intellectual Property.

IMMUNOGENICITY Guiding Development Of Novel Drugs
During the next decade, pharmaceutical companies hope to introduce a new generation of biotherapeutic drugs that are safer and more effective. Many members of this new breed are fragments of antibodies that reach targets that whole antibodies cannot. This is proving useful for treating diseases once thought to be beyond the reach of antibodies...

Clinical Trials Enterprise In India
The Contract Research Organisation has emerged as a dynamic element in the drug development process. What began as an outsourced outfit in the late 1990s to provide support and facilitate non-core pharmaceutical activities, the CRO today is more of a strategic partner rather than a mere service provider. The drivers for such a growth are increasing prevalence of diseases, rising healthcare spending, increasing affordability and better IP protection norms...
- Lakshmi Balachandran, Medical Writer, Karmic Life Science

CORPORATE AFFAIRS

Events Diary
• Biosimilars Drugs for Life
• Medifest South Africa
• 17th MDMA Annual Meeting
• US-China Food and Drug Law Conference
• IndiaMART Famdent Show
• World Pharma Innovation Congress 2011

Product Trends
• RX ACCULINK ® CAROTID STENT
• RIO™ - ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
• ABBOTT FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
• RAPID PROTEIN PRECIPITATION STRATA® IMPACT

New Instruments
• Sartorius Stedim Biotech Launches UniVessel® SU
• Brain Cancer Can Now Treated with New NovoTTF-100A System
• World's Smallest, Thinnest Gen-Next CRT-Ds, ICDs Launched

Alliances & Acquisitions
• Perkinelmer Acquires Geospiza
• Alkermes to Merge with Elan Drug Technologies
• Nkunzi Pharmaceuticals Gets MPM's Employees as Omame Acquires Significant Stake
• Dabur Acquires '30-plus' Brand from Ajanta Pharmaceutical

New Drug Approvals
• Novartis' New Pill Rasilamlo® for High BP Patients Gets EU Approval
• Linagliptin tablets for type 2 diabetes gets FDA nod
• Abacavir Sulfate, Lamivudine Get FDA's Tentative Approval
• Novartis drug Votubia Gets Swissmedic's Approval
• WG, MPA Patients Can Now Treated with FDA-approved Rituxan

Launches
• Colour Coating Tablets Get BASF-X-Rite Makeover
• FNIH Biomarkers Consortium Launches Study to Develop Diabetes Diagnostic Tools
• Sanofi Launches First 5-in-1 Combination Vaccine in China

INTERVIEW

Leapfrogging Into Growth During This Decade

Ranjit Shahani, Vice Chairman & Managing Director, Novartis India Ltd., in his key note address during Pharma Bio World Expo 2011, speaks about the trends, opportunities and challenges that will drive the growth of the pharmaceutical industry in this decade. He emphasised on biologics as it has revolutionised the modern medicine offering real hope for many unmet medical needs... - Ranjit Shahani, Vice Chairman & Managing Director Novartis India Ltd.

FEATURES

Nutraceuticals: Riding The Barometer Of Success
Health can be broadly explained in a layman’s statement as the absence of disease, which is measured by the empirical numbers like Blood and Urine Counts, Temperature, Pulse and BP etc. When you examine a large number of healthy people, you will be surprised to find that most of them will not be found to be in conformity with these empirical numbers that are considered to indicate good health. On the other hand, many patients acutely suffering with different disabilities will be found to be in strict conformity with these numbers... - Gopal Ramurthi, Managing Director Of Twilight Litaka Pharma Limited

Post-trial Access To Medication: a Question of Ethics or Feasibility
Conducting clinical trials in developing countries like India have become very lucrative in the recent times. But is it ethical or feasible to continue treatment of subjects taking part in the trial, even after the trial is over. Jeroze Dalal, Head-Clinical Operations, GSK Pharmaceuticals Ltd. gives her personal views on the pros and cons of this treatment... - Jeroze Dalal, Head-Clinical Operations, Gsk Pharmaceuticals Ltd.

Trends in Biopharmaceutical Manufacturing Facility Design
Historically, pharmaceutical manufacturing has been conservative and relatively non-innovative, owing in part to regulatory constraints and rigorous process validation, which discourage continuous improvement. Today, however, the global pharma industry is continuing to embrace the science and risk-based approach towards compliance, paving the way for implementation of advances in manufacturing technology. Significant opportunities now exist for improving manufacturing processes and quality assurance through innovation. The industry is moving towards implementation of Process Analytical Technology (PAT) and Quality by Design (QbD), with attendant opportunity to adopt a culture of continuous improvement. Roshni Dutton talks about Process technology advancements and equipment technology advancements such as single-use-technology and isolation technology that are redefining the manufacturing space, at Pharma World Expo 2011...
- Roshni Dutton, Biopress Expert, Snc-Lavalin Pharma

Kinase Drug Discovery At UNC
The primary quill of kinases has been on oncology drugs since ages of research. This enzyme modifies other proteins by chemically adding phosphate groups to them. The Centre for Integrative Chemical Biology and Drug Discovery (CICBDD), founded in January 2009 with the mission to take small molecule probes with the research mission from North Caroline, has dedicated biochemists working on this. It has been selected as NCI Comprehensive Chemical Biology Screening Center in 2009 (NCI CBC). The pre-projects running at CICBDD include GRK2/3, HO-1, TTK, TAT pathway, TgCDPK1, G alpha, TLR, P70S6K, HIV-MA-CA. Assay development includes PAP, Mer- cellular, LKB-1, IKK panel-(4). It discovery includes Mer-backup, TRAI, Ror2. Hit-to-lead includes crucial epigenetic L3MBTL1, L3MBTL3, Eppin etc. and the most important part for the lead optimisation is Mer. Funding for this work was provided by the NC TraCS Institute, UCRF and NCI. William Jansen of UNC addresses about the Kinase Drug Discovery process carried out at UNC during Pharma World Expo 2011...
- William Janzen, Cicbdd, University Of North Carolina

CORPORATE AFFAIRS

Events Diary
• International Pharmaceutical Exhibition
• FCE Pharma
• Pharmaceutics
• China International Pharmaceutical Machinery Exposition
• Conference on Biosimilars: Drugs for Life
• Pharmatech Bangkok

Product Trends
• Trelleborg helps in the race towards a fail-safe syringe pump
• Tecan Infinite F200 PRO offers flexibility for drug discovery
• ALPS 3000 for Optimal Robotic Integration, but with a Human Touch
• 9210 Silkosat Silica Analyzer

New Instruments
• Thermo Fisher Scientific Launches New Portable Near-Infrared Spectrometer
• Tecan And Scirobotics Offer Integrated Colony Picking For Molecular Biology
• New Desktop Liquid Handling Instrument From Biohit

Alliances & Acquisitions
• Case Western Signs Technology Licensing Deal With Neoproteomics
• Unimark Remedies Enters Into Strategic Contract With Hikma Pharmaceuticals PLC
• Dr Reddy's Takes On GSK's US Penicillin Facility
• Cellmid Inks Antibody Humanisation Collaboration

New Drug Approvals
• Horizant Gets Approval To Treat Restless Legs Syndrome
• Fda Approves Makena Injection To Reduce Risk Of Preterm Birth
• Aurobindo Receives Nod For Selling 'Galantamine Tablets'
• US FDA approves new treatment for melanoma patients
• Bayer's Gadavist injection gets US FDA nod

Launches
• Olink Bioscience Introduces Its New Plasma Biomarker Discovery Service
• Fda Launches Consumer-Friendly Web Search During Recalls
• Dr reddy's launches xyzal's generic version

INTERVIEW

"Our Metal Detection Systems are recommended in all stages of process line"

Unique Equipments, an ISO 9001:2008 certified company was founded in 1999. Since then it has evolved as one of the leading Manufactures and Exporters of Metal Detectors and other pharma machines in India. According its MD, Pravin Parker, over the years the company has developed core strength in manufacturing a comprehensive range of Metal Detectors that deliver Quality, Reliability and Performance. These products are continuously updated to meet the requirements of its customers and to the latest industry standards... - Pravin Parker, Managing Director, Unique Equipments, Goa

FEATURES

Heat Transfer Fluid An Essential Heat Transfer Media
In industrial processing, Heat Transfer Fluid (HTF) flows through jacketed reactors to prevent its overheating, transferring the heat produced by the device to other devices that use or dissipate it. An ideal HTF has high thermal capacity, low viscosity, is low-cost, non-toxic and chemically inert, neither causing nor promoting corrosion of the cooling system. Huber utilises Thermofluid SilOil M80.100.03 as one of the HTF composed of Polydimethylsitoxanen and Polyphenylmethylsiloxanen... - K Ravindra Prasad, Director, Huber Process Control Systems India Pvt Ltd

DNA BANKING GENETIC INTEREST Low Cost, Generic Molecular Markers For Breeding And Research
Genes available in wild plants and animals are being constantly used by breeders to improve yield, quality and nutritional value of crops and farm animals. The concept of DNA as a genebank resource has emerged out of the revolution in genomic information brought about by the analysis of DNA extracted from numerous plant species in laboratories across the world... - J L Karihaloo, Asia-Pacific Consortium On Agricultural Biotechnology Ltd

Biosafety of Bt-Crops Safe Transition
Insect pest management in agriculture is important to safeguard crop yields and productivity. A large number of chemical insecticides that effectively control insect pests have been proven to be harmful to human health and environment. There is a need to reduce the dependence on pesticides by using safer alternatives to manage insect pests. Many insecticidal proteins and molecules are available in nature, which are effective against agriculturally important pests but innocuous to mammals, beneficial insects and other organisms...
- P Ananda Kumar, Nrc On Plant Biotechnology

CORPORATE AFFAIRS

Events Diary
• SAUDI HEALTHCARE
• BIOMEDevice Boston
• Rehmed Expo
• Health Industry
• MSL Expo 2011
• Healthcare Ireland

Product Trends
• UNIPHARMA METAL DETECTOR FOR ALL YOUR STRINGENT NEEDS
• C6 FLOW CYTOMETER® ON YOUR BENCHTOP MAKES LIFE EASY

New Instruments
• Arizona Instrument upgrades Computrac moisture analysers
• Medtronic launches Achieve Mapping Catheter in Europe
• Thermo Fisher Scientific introduces Syncronis Range of HPLC Columns
• Flexible, Adaptable Column by Thermo Fisher Scientific for Nanoscale HPLC

Alliances & Acquisitions
• Fortis Ties-up With Totipotentrx For Stem Cell Centres
• instrAction and Protagen Contour Strategic Alliance
• Amgen to acquire Pfizer’s Irish plant
• Surya Healthcare Buys Medimart

New Drug Approvals
• Hospira wins approval for Taxotere
• FDA approves Edarbi to treat hypertension
• FDA Approves Daliresp to Treat Chronic Obstructive Pulmonary Disease
• Benlysta receives a breakthrough FDA approval

Launches
• Hamilton Launches Microlab 600 Series Diluters/Dispensers
• Telome Health, Inc Launches with Exclusive IP Portfolio
• Thermo Fisher Scientific Announces Two New Persistent Organic Pollutant Screening Kits
• Remi Unveils New Compact Benchtop Centrifuges

INTERVIEW

"WATER IS THE CORE BUSINESS"

Beginning from Nehru time to date, India and the Czech Republic have been sharing a cordial relation. The companies from Czech Republic have many new technologies in the water field to offer. Indian companies can indeed benefit from it. Miloslav Stasek, Ambassador to India, Embassy of the Czech Republic talks about the scope of water business in India... - Miloslav Stasek, Ambassador to India, Embassy of the Czech Republic

"ISOLATION TECHNOLOGY REDUCES COST OF CLEAN ROOMS"
GMP Technical Solutions (GMP Tech) is one of the largest manufacturers of Demountable Partitioning Systems and doors within the Indian subcontinent. GMP Tech has already made its mark in the export market by tying up with various international vendors for indigenisation and delivering competitive products. Ravi Thakur, Vice President- Marketing, GMP Technical Solutions Ltd talks to PBW about the clean room technology, its relevance and developments... - Ravi Thakur, Vice President- Marketing, GMP Technical Solutions Ltd.

"OUR OUTPUT QUALITY PARAMETER OF PHARMA WATER SYSTEMS IS AS PER USP GUIDELINES"
Nilsan Nishotech is a project engineering company with the vision to provide innovative solutions to create value for customers in the areas of separation technologies, high purity pharma water systems - pretreatment, generation, storage and distribution - and sterile process piping. Sanjay Badani, CEO, Nilsan Nishotech talks about the importance of processed water as the most critical need of the therapeutics and the company's output quality parameter of the pharma water systems... - Sanjay Badani, CEO, Nilsan Nishotech

FEATURES

Impurities in raw water
In water purification system, pretreatment plays a major role as it helps to remove most of the contaminants and helps enhancing life of costly membranes and cartridges in mainstream system. Identifying the types of contaminants found in water helps to review the ways these contaminants may be removed from feedwater. Suhas Gogate, Product Manager, Toshvin Analytical Pvt Ltd, talks about water purification systems...
- Suhas Gogate, Product Manager, Toshvin Analytical Pvt Ltd

GREEN CHEMISTRY SUSTAINABILITY, A 'Must Have' For Pharma Industry
Intertek is active globally in providing sustainability related services to diverse industries. The sustainability consulting team at Intertek has over two decades experience in this field. Their services can be divided into Lifecycle Assessment Services, Carbon Foot printing Services, Social Responsibility Services. Explaining the sustainable strategy, Vijay V Bhujle, Head Expert Services - India, INTERTEK INDIA PVT LTD, talks about the relevance and need of green technology...
- Vijay V Bhujle, Head Expert Services - India Intertek India Pvt Ltd

Solvent Separation by Pervaporation & Vapour Permeation
Techniques like pervaporation using membranes are making the processes greener by not only reducing the energy costs of separation but also breaking the azeotropes without the use of secondary solvents. Zeolite NaA-membranes find a good application in chemical, API as well as pharmaceutical industry where there is a need for efficient separation technologies for separating organic solvents...
- Lalit Vashishta, MD, Diva Envitec Pvt & Marcus Weyd, Ingolf Voigt, Fraunhofer Institute for Ceramic Technologies and Systems, Germany

Evaluating biological Safety Cabinets Comparison between European and U.S. Standards
The EN 12469:2000 is the harmonised European standard for microbiological safety cabinets. The ANSI / NSF 49 is the American National Standard which also specifies requirements for both cabinet construction and performance criteria. Lin Xiang Qian, Group C.E.O of Esco attempts to highlight and discuss the differences between each standard....
- Lin Xiang Qian, Group C.E.O of Esco

CORPORATE AFFAIRS

Events Diary
• MEDTEC EUROPE
• MEDICAL FAIR INDIA
• MSL EXPO
• BIOLOGICA
• DUBAI PHARMACEUTICAL and TECHNOLOGIES EXHIBITION
• SOUTHEAST ASIAN HEALTHCARE and PHARMA SHOW

Product Trends
• Xytos Introduces Their Cancer Diagnostic Fluorescent Scanning Technique
• Maxx Medical launches Freedom Total Knee System

New Instruments
• Neuroform EZ™ Stent System For Brain Aneurysm Surgery
• Mascon High Purity Biotech and Aseptic Valves
• Medtronic Announces Launch Of Cd Horizon Solera™ Spinal System
• FDA approves first 3-D mammography imaging system
• Covidien gets FDA Clearance for New LigaSure™ Instrument

Alliances & Acquisitions
• Valeant Buys Pharmaswiss For Cee Generics Market
• Oxford Biomedica Buys Uk Plant
• Cadila And Bayer Healthcare To Market Products Together
• Ranbaxy Signs Mou With Russia's Yaroslavl Region

New Drug Approvals
• Fda Grants Full Approval For Promacta® For Treatment Of Rare Blood Disorder
• Fda Approves Makena Injection To Reduce Risk Of Preterm Birth
• Fda Approves Viibryd To Treat Major Depressive Disorder
• Fda Approves Rituxan For Treating Follicular Lymphoma
• Fda Approves Novartis' Meningococcal Conjugate Vaccine, Menveo

Launches
• Scalene Greenergy Corporation Launches Micro And Mini Serigastm Organic Natural Gas Plant
• Ivi Launches Dengue Vaccine Initiative
• Lincoln Pharma Launches 'Pa 12' Paracetamol Pill
• Religare Sets Up 24x7 Healthcare Assistance Service

FEATURES

Treating Pharma Industry Effluents

Pharmaceutical and bulk drug industries emanate effluent which consists of high organic contents with high COD. SSP has developed a system to treat such effluent through evaporation and drying technology and by removing the solvent from high COD stream using stripper column. With the help of this technology, effluent concentrate is dried to a baggable powder with 6-8% moisture content, which can be reused as a land filling /disposal. R P Banerjee, CEO, SSP Pvt Limited who recently received ‘Life Time Achievement Award’ from All India Achievers Forum for his contribution to the industry, talks about SSP and how it benefits the pharma and bulk drug industry... - R P Banerjee, CEO, SSP PVT LIMITED

Laboratory Safety – A Vital Concern
A world-class laboratory is safe, functional, flexible, aesthetic, ergonomic and user-friendly. Safety is achieved by proper selection of Fume Hoods and a good Laboratory Airflow System. Laboratories use toxic, hazardous, radiation and biohazard chemicals. If such chemicals are inhaled continuously over long periods, this adversely affects the health of the persons working with them... - Mayur Patel, MD & Chairman, Gordhandas Desai Pvt. Ltd

The State-of-the-Art Microencapsulation Technology
Microencapsulation is a process of enclosing micron-sized particles in a polymeric shell. It has various applications in pharmaceuticals, food and neutraceuticals, consumer and diversified products, agricultural and industrial fields. Here is a review of different microencapsulation techniques and its applications in various fields... - A.Sindhura, N. Kanaka Durga Devi, B.Sai Mrudula, K.V.S.R. Siddhartha College of Pharmaceutical Sciences, Vijaywada - AP

Pharmaceutical Plant Disinfection: The Acid Test
Choosing a suitable disinfectant for a pharmaceutical operation can be a complex process. Christopher Fournier* and Dominique Leclercq** of Mar Cor Purification, outline the main considerations set down by the FDA and in the US pharmacopoeia...

Changing HPLC Trends in today's Lean Laboratories
High pressure liquid chromatography (HPLC) has for many years been a routine analytical technique built on robust column technology and reliable instrumentation. Each analytical laboratory has accumulated dozens, if not hundreds, of methods typically taking 20–60 min or even longer...
- Tanay Waingankar, Life Science Industry Marketing Manager Agilent Technologies

Clean rooms, an indispensable Pharma need
Production and fitting can, like surgical operations, be impaired by particles and germs which are present in the atmosphere of the room. For this reason, sensitive processes and operations are carried out in special rooms or parts of rooms - the clean rooms...
- Joerg Fitzek, Managing Director R.STAHL (P) LTD.

CORPORATE AFFAIRS

Events Diary
• Healthcare Infrastructure & Medical Technology
• South MediLab Expo
• BioPharma Asia Convention 2011
• PHARMA WORLD EXPO 2011
• 2nd International CIS Pharmaceutical Forum
• World Generic Medicines Congress

Product Trends
• PTFE Stockshapes and Machined Components
• Kinetic Concepts, Inc. V.A.C.(R) GranuFoam™ Bridge XG Dressing
• Health Canada Approves Removable GORE(R) VIABIL(R) Biliary Endoprosthesis
• GE Healthcare's DaTscan Receives FDA Approval

New Instruments
• Neuroform EZ™ Stent System For Brain Aneurysm Surgery
• XCELLigence System RTCA HT For Real Time Cell Analysis
• Teem Photonics chooses PI's NanoCube® for 3D structuring applications
• Ex D IIB Clean Room Light fitting (2 * 36W CFL)

Alliances & Acquisitions
• Praj Industries & Qteros announce partnership to accelerate global commercialisation of Cellulosic Ethanol
• Boehringer Ingelheim and Eli Lilly And Company to bring new Diabetes Treatments to Patients Worldwide
• Thermo Fisher acquires Lomb Scientific

New Drug Approvals
• Abbott Receives CE Mark Approval For World's First Drug For Treatment Of Coronary Artery Disease
• FDA Approves Opioid Analgesic To Help Cancer Patients Manage Pain
• INVEGA gets approval as first antipsychotic treatment for Schizoaffective disorder
• FDA approves new dosage for INTELENCE

Launches
• Crospon's latest EndoFLIP product
• Intas launches HIFENAC INJECTION
• MOXICIP KT FOR POST-OPERATIVE CATARACT SURGERY CARE
• Illumina announces next generation of iSelect custom genotyping products

COVER STORY

NNE Pharmaplan: Foray into niche biotech sector

NNE Pharmaplan is the world's leading engineering and consulting company in the complex field of pharma and biotech. Their subsidiaries and field offices around the world ensure that their clients have access to global services and local expertise in all markets significant to the pharma and biotech industries like pharmaceuticals, biopharmaceutical, vaccine, containment, medical devices etc. Dr. A. K. Singal is the Founder/Managing Director of NNE Pharmaplan India. As the head of the organization, he has spent the last 20 years working with biotech and pharmaceutical projects... - Dr. A. K. Singal, Founder/Managing Director, NNE Pharmaplan India

FEATURES

Right Vacuum Systems for Pharmaceutical & Chemical Plants
Technological advancements have not only played a big role in progression of mankind but also sharpened and made human brain more analytical to distinguish the best among good. Availability of various types of vaccum pumps in the markets make the end users perplexed at the time of purchasing pumps. The article talks in details about vaccum pumps and their utility and design... - Amit Kapur, Director

Disease Registry: The battle against time!
The challenge of chronic health hazard is the real pain for humankind since the time of Hippocrates. Since ancient days healthcare systems were always in search of a sword to conquer this battle. Unfortunately the search is not still over and the chronic illnesses continue to lead both in terms of mortality rates as well as tremendous economic burden on nation. More than 130 million Americans live with chronic diseases and chronic diseases account for 70% of all deaths in the US. The medical care costs of people with chronic diseases account for more than 75% of the nation's $2 trillion medical care costs...

Pharmaceutical Tablets - To Image Or Not To Image?
This white paper discusses the considerations involved in selecting a spectroscopic approach for the chemical analysis of pharmaceutical tablets. It focuses on the differences between a bulk, i.e. single-point, analysis and the more detailed mapping and imaging approaches now available. Understanding the key considerations and the performance differences between approaches can help in making an informed choice about which technology best suits your needs. This document offers general guidance and suggests some questions that should be answered before you go on to consider the more technical aspects of the techniques, such as chemical specificity or performance, for specific applications...

CORPORATE AFFAIRS

Events Diary
• 3rd Herbal International Exhibition cum Summit on Medicinal & Aromatic Products, Spices and finished products (hi-MAPS)
• PHARMA WORLD EXPO 2011
• Aquatech India 2011
• 8th Everything About Water Expo 2011
• 4th annual BioPharma Asia Convention 2011
• 2nd International CIS Pharmaceutical Forum

Product Trends
• First hot melt extrusion compendium now available
• Pharmaceutical Industry Trends - Global Scenario
• Asia Pacific Pharmaceutical Market
• Middle East Pharmaceutical Market
• Pharmaceutical Drugs Trends

New Instruments
• Disposable Turbine for single patient use
• SiriusT3 for pKa, logP/D, Solubility & Dissolution
• Pharma Mill for Herb/Medicine
• OmniView Cylindrical Package Inspection System

Alliances & Acquisitions
• Rallis buys majority stake in Metahelix
• Opto Circuits acquires Cardiac Science
• Cephalon to acquire about 20% stake in Mesoblast
• Mergers and Acquisitions in Indian Pharmaceutical Sector

New Drug Approvals
• Axiron Is Approved by FDA
• FDA Approves Gablofen
• FDA Approves Halaven
• FDA Approves Egrifta
• Ofirmev Approved by FDA

Launches
• Italy: new hospital drug launches threaten reimbursement
• Sinclair partners Sunstar to launch oral care product Decapinol in US

COVER STORY

Pharmaceutical Counterfeiting

Pharmaceutical counterfeiting, tampering and diversion-the three biggest threats to the integrity of the global drug supply are escalating. The advent of inexpensive and sophisticated imaging technologies and the growth of Internet sales and distribution channels provide criminals with the means to make convincing fakes with little training or capital...

FEATURES

Drug Discovery
The drug discovery process is the fundamental source of active principles, i.e. compounds which interact as agonists or antagonists, functionally or structurally, with constituents of living organisms. Drugs arise from either natural sources, with an almost infinite variety of molecular structures, or are designed with the target effect or molecule in mind [using quaternary structure–activity relationships (QSAR)]. The combination and creative utilization of several areas of scientific studies, i.e. genomics, proteomics, bioinformatics, structural analysis and functional experiments plus advanced chemistries, will provide significant results in the next decades...

Biogenerics or Biosimilars
The first generation of biological drugs, which have introduced many revolutionary treatments to life-threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop "generic" substitutes to original biologics, which are also known as biosimilars. Yet the field of biosimilars presents several important challenges - safety, regulatory, legal and economic - which are the topic of discussion across the globe. Most of these discussions stem from the idea that, unlike the relatively straightforward process of introducing a generic equivalent to an original drug based on a new chemical entity (NCE), the process of introducing a biosimilar to an original biological drug is far more complex...

Super Generics: An Innovative Alternative To Generics
In recent years, it has become increasingly more difficult and expensive to discover, develop and launch new chemical entities (NCEs). Failure rates for NCEs in clinical development have reached levels as high as 80%, and the approval of NCE’s by the FDA has declined drastically. These put tremendous pressure on pharmaceutical companies to look for new business opportunities within their marketed product portfolio to balance this risk. Super generics offer real product differentiation, patent protection, and branding opportunities for product manufacturers. This new product category addresses an important market need to expand the availability of important therapies and reduce time to market...
- Dr. Amrita N. Bajaj & Ms. Anjali H. Singh, C.U. Shah College of Pharmacy, SNDT Women's University

A Cure for Hammer Rash: Measuring Powder Flowability With Shear Cell Testing
Preventing discharge problems in vessels and containers requires a detailed understanding of the powder's flow characteristics. The functioning of a shell tester can simplify and speed tests for measuring powder's flow behaviours. With builting software to quickly analyze the test results, this instrument is moving shear cell testing from its establishment place in R &D labs into the world of quality control for day-to-day bulk solids production...
- Robert G. McGregor, Brookfield Engineering Laboratories

Compliance, Risk and Cost of Ownership Comparisons for Pharmaceutical Continuous Monitoring - Wired, Wireless and Standalone Monitoring Systems
Recent agreements between the US FDA and its European Union counterparts to cooperate on pharmaceutical plant inspections to enable stepped up enforcement of safety guidelines require every pharmaceutical manufacturer to be on higher alert to maintain a best-practice focus on quality systems. These agreements will help regulators be more efficient with their resources. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more GxP facilities being audited. Revisiting cost-vs.-benefit analyses for continuous monitoring modalities (wired or wireless networks and standalone monitoring instruments) that facilitate the ability to comply with auditors' requests for proof of regulatory compliance is very timely. Moreover, the ever increasing costs for APIs and the R&D efforts to create them are such that the economic costs of failure in the totality of monitoring systems are greater than ever before. All monitoring methods-whether wired, wireless or standalone instrumentation-need to be scrutinized for systemic weaknesses that allow human error to compromise product quality, system failure probabilities and overall costs of ownership...
- Ken Appel, Manager Regulated Markets Veriteqs

CORPORATE AFFAIRS

Events Diary
• BioPharma India Convention 2010
• Medifest
• CPHI / P-MEC India
• BioPharma Asia Convention 2011
• LogiPharma Asia 2010
• Biological Manufacturing World India 2010

Product Trends
• Chemical Magnetic Drive Pump
• Programmable Logic Controller
• Fluoropolymer Coatings and Linings
• Metal Detectors
• Solid Drug Layering
• AFT - 90 Capsule Filler

New Instruments
• Thermo Fisher Scientific Launches New Environmentally Friendly Ultra-low Temperature Freezer at ILMAC 2010
• Met One Launches Model Airborne Particle Counter With 100 LPM Flow Rate
• Stratophase to showcase real-time, in-line process monitoring system at EFIB 2010

Alliances & Acquisitions
• The OTC pull
• Time for change
• Strip down
• Glaxo sees more industry consolidation

New Drug Approvals
• Bafna gets Ghana FDA approval for hypertension drug
• Surya Pharma board's nod for stock split
• gets US health regulator nod for anti-allergic tablets
• DRL gets nod for Allegra D-24 generic

Launches
• Glenmark moves closer to HIV drug launch
• Rexahn Pharmaceuticals Announces Publication of New Preclinical Research Data for Novel Anticancer Compounds

COVER STORY

API on Roll

Active Pharmaceutical Ingredients (API) of good quality are core to the manufacturing of effective and safe essential drugs. The price of APIs is the main cost driver for manufacturing. Only a limited number of large manufacturers of finished pharmaceutical products have their own API manufacturing capabilities and none of them can make all required APIs in-house...

INTERVIEW

Demand for adopting laboratory technology goes hand in hand
Michelle A. J. Palmer, Ph.D. is Director of Discovery and Pre-Clinical Research in Chemical Biology at the Broad Institute of Harvard and MIT. She leads a team of assay development, HTS, and automation scientists that provide a wide range of assays and screening capabilities to academic collaborators for probe and drug discovery. She led an assay development and HTS team at the Genetics Institute for nine years and cell biology screening technology development at Applied Biosystems for eight years. Dr. Palmer has also founded and directed a small biotechnology company, Cell NetwoRx, and worked as a life science consultant. She obtained her Ph.D. in chemistry from the Massachusetts Institute of Technology, and currently serves as President of the Society for Laboratory Automation and Screening...
- Dr Michelle Palmer, President, Society of Lab Automation & Screening

Safrroys Machines Pvt Ltd is a leading manufacturer of the automatic hard capsule machine
Mr. Neville Vkoithara has a MBA degree from the prestigious INSEAD Business School, France to his credit. After the completion of his studies he worked in the pharmaceutical consulting sector in Europe for a brief period. This phase helped him understand the best practices to be followed in the pharmaceutical industry and he returned to India to implement the same as a supplier to the pharmaceutical sector...
- Mr. Neville Vkoithara, Managing Director, Safrroys Machines Pvt Ltd

FEATURES

The Evolving Dynamics Across Pharmaceutical Value Chain
The pharmaceutical industry in Asia and more particularly emerging markets like India and China are in the midst of a growth phase that may be equated to the speed of the engineering marvel .At a global level however, growth rates are slowing down. Along with the slow recovery from subprime crisis, the pharma business is also faced with multiple longer standing constraints like higher clinical development costs, paucity of blockbusters, declining sales force effectiveness, increasing competition from generics etc. At the outset companies have begun to ruthlessly cut costs to improve their profit margins...
- Dr. Rajesh Prabhakaran, Co-founder & Director, BioQuest Solutions Pvt. Ltd.

Run For Trial
The global clinical trials business was worth an estimated $50bn in 2008, with a growth rate of 10 percent. The market is expected to show considerable growth in the future. Reduced R&D productivity and ever-increasing cost of drug development program are forcing the pharmaceutical and biopharmaceutical majors either to conduct clinical trials in developing nations or to join hands with contract research organizations. Countries like India, China, Latin America, Brazil and Argentina are the top player in this ‘Run for Trials.’ The need for the next blockbuster drugs and patent expirations has lead to increase in number of trials being conducted globally with special consideration for ease, speed and retention of volunteers which figures prominently. Contract Research Organizations have registered a significant growth in past and are bound to flourish in the coming years irrespective of indication or region. The new emerging economies offer significant opportunities in terms of not only patient recruitment but the entire package (infrastructure, modern facilities, trained and experienced PI’s, ICH GCP compliant staff, transparent approval process, respect for intellectual property rights, and cultural sensitivity, among others). To sustain CRO growth and the search for international compatible sites has become indispensable...
- Dr. Naresh Tongay, Director - Perrfect CRA Training Centre, Mumbai

Biopharmaceuticals: Booming Industry
Biopharmaceuticals refers to the protein, synthesized by genetically engineered biological system or by hybridoma technology. They are proteins including antibodies, nucleic acid etc. used for diagnostic purposes and is produced by means other than direct extraction from a native source. Biopharmaceuticals are therapeutic or preventative medicines that are derived from living cells, using recombinant DNA technology...
- Sachdev Yadav, Assistant Professor (Pharmacology), Shruti Mishra, Ranjana Singh, Pooja Singh, PG Scholar, Department of Pharmacy

Clinical Sites Patient Recruitment Strategies in India
In 2004, Mckinsey & Company conducted an analysis on site performance. The results found that 30 percent of sites enrolled 70 percent eligible subjects in a trial, 50 percent enrolled zero to two subjects & 20 percent enrolled more than 2 subjects, but well below the contracted total. When 70 percent of the sites did not perform to contract, overall delays in meeting enrollment milestones resulted. In 2009, results of another analysis were a bit better. 55 percent of trials were able to finish enrolment early or on time, but the remaining 45 percent completed enrolment late. Most of the late trials took up to twice the original timeline, but 10 percent took even more...
- Dr. Pratik Shah, Head-Medical & Clinical Research, Astellas Pharma India Pvt Ltd.

Automating Discovery
Today's drug discovery com-panies are challenged with getting quality leads into their development pipeline, leads that are 'druggable' – active, selective, available, and safe. At the center of the drug development cycle is high-throughput screening (HTS), where developed and validated targets are tested against a panel of effectors of chemical or biological origin. HTS allows scientists to rapidly identify lead candidates from libraries that can contain hundreds of thousands to millions of potential candidates. ..
- Marc Beban, Agilent Technologies, Inc.

CORPORATE AFFAIRS

Events Diary
• BioPharma India Convention 2010
• Medifest
• CPHI / P-MEC India
• BioPharma Asia Convention 2011
• LogiPharma Asia 2010
• Clinical Trials in CNS

Product Trends
• Homopolymer Propylene Valves
• Continuous Heavy Pouch Sealer
• Oscillating Granulator
• Water Purification System
• Filters
• Pulveriser/Micro Pulveriser

New Instruments
• Thermo Fisher Scientific Introduces New Syncronis Range of HPLC Columns at ISC 2010
• Quality Seal for Pharmaceutical Containers
• Omnifit® Labware T-Series Solvent Waste Bottle Cap Traps Harmful Vapours

Alliances & Acquisitions
• Glenmark and Lay Line Genomics in pain-killer drug pact
• Biocon and Pfizer Enter Into Global Commercialization Agreement
• Socrus Bio Sciences acquires Anti-Obesity brand
• IDT and 454 Life Sciences in pact to provide custom primers for GS FLX Titanium Chemistry

New Drug Approvals
• Mylan gets OK for generic blood pressure drugs
• Tris Pharma receiveD FDA final approval for generic Tussionex ANDA
• Lupin Announces Final FDA Approval of Generic Hyzaar® and Cozaar®
• Sun Pharma announces USFDA tentative approval for generic Stalevo

Launches
• Roche Officially Launches Avastin in China
• Sciences launches Stem Cell Collection Centre in Mumbai
• Celeromics launches new line of cell counting devices

COVER STORY

The Packaging Function

Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements...
- D. A. Dean, Packaging Consultancy Education & Training, Nottingham, UK.

INTERVIEW

Lab automation technologies is Growing World Over
Dr. Steve Hamilton is Director of Education for the Society for Laboratory Automation and Screening. He holds a Ph.D. in Analytical Chemistry from Purdue University, and has over 25 years of experience in leading laboratory technology programs in companies such as Eli Lilly, Amgen and Scitec. He received the Pioneer in Laboratory Robotics award in 1986, the Scitec/TNO award in 1992 and the ALA Achievement award in 1999. He is the author or co-author of over 60 papers and abstracts, and has been teaching short courses on laboratory automation at international meetings since 1992...
- Dr. Steve Hamilton, Director of Education, for the Society for Laboratory, Automation and Screening

FEATURES

Pharma Packaging Machinery: Future Prospect
The total production of packaging machinery in value terms is estimated at '260 billion in 2008-09, which has grown at a CAGR of 10% over the period FY05-10. Blister packaging machinery represents the largest segment of the Pharma packaging machinery with a production value of '58 billion, occupying 20% of the total production. While liquid and corrugated packaging machinery contributed 10% each, other packaging machinery made up 5% of the total production of packaging machinery in FY10...

Packaging Breakthrough: Image-based ID Readers
Image-based ID readers stand poised to replace laser scanners in a wide range of industries including food,beverage, consumer goods, pharmaceutical and automotive, but when considering a transition from laser scanners to image-based barcode readers many think the cost too high...
- Didier Lacroix, Senior Vice President, International Sales & Services, Cognex

Nanotechnology to Drive Innovation IN Drug Delivery
Nanotechnology is an exciting area in healthcare, particularly drug delivery. It has many challenges to overcome, both from technological and regulatory standpoints. However, the potential benefits of improving human health, across a wide range of applications are enormous. The small size, customized surface, improved solubility and multi-functionality of nanoparticles will continue to open many doors and create new biomedical applications. The term ‘nanotechnology’ might conjure up images in the popular press of miniature machines in the body. Nanotechnology is the latest buzzword for a technology that is advancing rapidly. In many cases, it is a valuable step in the process of developing new, safe, improved therapeutics and devices. Current research in drug delivery systems is focused in development of innovative nanomaterials and nanorobots...
- Dr. Amrita N. Bajaj & Ms. Anjali H. Singh

Therapeutic Applications Of Cdk2 Inhibitors
Majority of cancers exhibit direct or indirect deregulation of CDK2 function together with higher expression of Cyclin E. Members of the CDK family and their associated pathways represent some of the most attractive targets for the development of anticancer agents...
- Maulik P. Suthar, Rajesh Singh, M.M. Patel

Formulation Design Approach To Avoid Dose Dumping
Dose Dumping can greatly increase the concentration of a drug in the body and thereby produce adverse effects or even drug-induced toxicity...
- Bhupendra G. Prajapati, Himanshu K. Solanki

CORPORATE AFFAIRS

Events Diary
• Biologic Manufacturing World India 2010
• Indian Pharmaceutical Congress
• IndiaPack 2010
• LogiPharma
• The World Stem Cell Summit
• P-MEC Europe 2010

Product Trends
• NexION300
• NanoVue™
• Capsule Filling Machine
• Laboratory Blistering Machine

New Instruments
• OGT Introduces Unique CNV Array with Whole Chromosome Uniparental Disomy (UPD) Detection
• Thermo Fisher Scientific Introduces Larger Volume Vials for Cryopreservation
• Nanoink Releases Two New Nanoscale Applications

Alliances & Acquisitions
• Aurobindo Pharma, AstraZeneca ink supply pact
• Jubilant Organosys signs contract with US Life Sciences Company
• Shasun Pharma inks pact with Nanopraticle Biochem
• Novartis concludes acquisition of 77% Alcon stake from Nestle

New Drug Approvals
• Sun Pharma receives USFDA nod for hyperactivity drug
• Novartis gets Russian regulatory nod for Gilenya®, an oral multiple sclerosis therapy
• Novartis Pharma Tekamlo gets FDA approval
• Korean FDA approves Nectar Lifesciences' Cefuroxime Axetil

Launches
• GE Healthcare and MDS Pharma launch cell genotoxicity predictor
• Bioniche Pharma and Synerx Launch Isosulfan Blue Injection 1%

COVER STORY

Big Patents Expiration 2010

Close to $63 billion worth of branded drugs are set to lose their patents between 2007 and 2012, paving the way for generic replicas. This year, to date, the biggest drug to lose its patent has been Sanofi-Aventis’ $2.2-billion sleep medication, Ambien...

INTERVIEW

Laboratory automation by encouraging study and advancement in science
Mr. Greg Dummer is a seasoned scientific society executive bringing more than 20 years of strong management and marketing skills as well as experience in strategic planning and innovative operations to the Society for Laboratory Automation and Screening (SLAS). Prior to being named the Chief Executive Officer of SLAS, Dummer served seven years as the Executive Director for the Association for Laboratory Automation - the only international association devoted exclusively to laboratory automation in its service to academia, commercial and government research, scientists, engineers and business professionals...
- Mr. Greg Dummer, CAE Chief Executive Officer Society for Laboratory Automation and Screening

Quality an attitude, a better way of working towards healthier life
Dr. Vishwanath B Malkar heads the Regulatory and Quality department of Reliance Life Sciences. A Ph.d in Analytical Chemistry, he joined Cipla and worked there for more than 10 years. Then he worked with Sekhsaria chemicals, Wockhardt and Taro Pharmaceuticals for many years...
- Dr. Vishwanath B Malkar, heads the Regulatory and Quality department of Reliance Life Sciences

FEATURES

Enteric Coating in Pharma Formulation
Polymethacrylates are used in Pharmaceuticals Enteric Coating Tablet. Neutral poly(meth)acrylic acid esters are pharmacologically inactive. Crosslinked copolymerizates based on methacrylic acid are used as ion-exchangers for the adsorption of active substances for retard preparations in the form of tablets...
- Dr. Naresh Tongay, Director – Perfect CRA Training Centre, Mumbai

Quality Management - Imperative Pre requisite
Flashback Indian Pharma Industry encompass quality producers and many units approved by regulatory authorities in USA and UK. International companies associated with this sector have stimulated, assisted and spearheaded this dynamic development in the past 53 years and helped to put India on the pharmaceutical map of the world...
- Dr. Kumud Sarin, Director, Bioinformatics Institute of India

Pharmaceutical Quality by Design
The Food and Drug Administration (FDA) Office of Generic Drugs (OGD) has developed a question-based review (QbR) for its chemistry, manufacturing, and controls (CMC) evaluation of abbreviated new drug applications (ANDAs). QbR is a new quality assessment system that is focused on critical pharmaceutical quality attributes...
- Dr. Lawrence X Yu, Ph. D. Director for Science, Office of Generic Drugs, Food and Drug Administration, US

Drug Discovery Development
Lean Six Sigma applied to the pharmaceutical and biotechnology industries has a dramatic effect on reducing cycle times and the cost of developing new technologies, products and protocols for research and clinical applications...
- Dr. Narendra Soman, GE Healthcare

Detecting GMP Failures
An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens?...
- Mr. Wolfgang Schmitt, Director of Operations, Pharmaceutical Consulting Alliance (PCA), Heidelberg, Germany

Change Control
Globalization of the marketplace has greatly intensified competition. It has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions...
- Mr. Wolfgang Schmitt, Director of Operations, Pharmaceutical Consulting Alliance (PCA), Heidelberg, Germany

CORPORATE AFFAIRS

Events Diary
• International Contract Services Expo-India
• 2010 India Excellence in Healthcare Awards
• BIO India International Partnering Conference
• India Lab Expo 2010
• Nanotech India 2010
• Stem Cells USA & Regenerative Medicine Congress

Product Trends
• Biovis Particles Plus: Particle Size Analyser
• Ecotrol – Operational Economy with Optimum Control
• Fluorin Plastic Single-stage Centrifugal Pump
• LPG Gas Leak Detector

New Instruments
• Thermo Fisher Scientific Launches Maybridge Ro3 Diversity Fragment Library to Enhance Structure-Based Drug Discovery
• ABB introduces 'research grade' spectrometer

Alliances & Acquisitions
• Merck to reacquire Riverside plant for key API supply
• Bayer in pact with 301 Hospital in China for research
• Endo Pharma To Buy Pain-Drug Partner Penwest For $168Mln
• Bliss GVS enters into JV with Saudi Pharma

New Drug Approvals
• Simcere Pharma gets SFDA approval to manufacture Palonosetron
• FDA Accepts Bayer Schering Pharma's New Drug Application for Gadovist
• Pfizer gets FDA Approval for Prefilled Dual-Chamber Syringe to treat Hemophilia
• UNICHEM LAB gets ANDA approval from USFDA for BISOPROLOL & HYDROCHLOROTHIAZIDE TABLETS

Launches
• RPG Life Sciences launches Impulse, boosts cardio-vascular portfolio
• Watson to launch emergency contraceptive ella in Q4 2010
• Fujitsu & University of Tokyo Launch Supercomputer for Drug Development