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EDITORIAL
Integration with an IT edge ome of the key challenges facing the pharma sector today include rising regulatory norms, fewer blockbuster discoveries, besides increasing pressure for higher efficiency at every stage with faster Return on Investment (ROI). In order to improve operational excellence, ensure optimum efficiency, increase productivity as well as reduce the manufacturing expenditure, strategic adoption of IT and automation becomes critical right from the process level to commercial manufacturing. Doing this can enable the pharma industry to successfully manage the complex requirements of bulk drugs and formulations business. It can also streamline procurement of raw materials and significantly reduce procurement & delivery cycle times. From the perspective of better information management, implementing appropriate IT & automated solutions can go a long way towards improved decision making and enhanced outcomes by conveying the right information to the right place at the right time. Besides, it can bridge the information gap between research and clinical care by bringing together heterogeneous data silos. In fact, the advent of integrated systems like Enterprise Resource Planning (ERP) offers immense opportunities to leverage
s
information silos albeit they may be spread across various departments. Emergence of new business models centered around novel concepts such as cloud computing - where IT infrastructure and application software are available as a service – holds a lot of promise, especially for the SME segment in the pharma space. With the Pay-per-Use model, the affordability of IT solutions may no longer be a major issue for the SME sector. Moreover, it can ensure that one can safely outsource the IT requirement or maintain it with minimal investment without fear of loss of data, downtime in production, etc. Going forward, as constant innovation propels technology-enabled business transformation in the pharma industry, the trend for offshoring and outsourcing is likely to get stronger. The ‘Industry Update’ offers more details. For the latest on OTC marketing & branding and the Pharma Census in the country, turn to the ‘Market Trends’ and ‘Roundtable’, respectively.
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Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Infomedia 18 Ltd and printed at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J.K.Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharmaceuticals is registered with the Registrar of Newspapers of India under No. 14798/2005. Views and opinions expressed in this publication are not necessarily those of Infomedia 18 Limited. Infomedia 18 Limited reserves the right to use the information published herein in any manner whatsoever. While every effort has been made to ensure accuracy of the information published in this edition, neither Infomedia 18 Ltd nor any of its employees accept any responsibility for any errors or omission. Further, Infomedia 18 Ltd does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition. No part of this publication may be reproduced in any form without the written permission of the publisher. All rights reserved.
Editor: Manas R Bastia
July 2010
Modern Pharmaceuticals
13
CONTENTS
48 42
F E AT URE S ROUNDTABLE Pharma census in India: A step forward for better governance?
IN FOCUS
34
38
Fabtech Technologies International Pvt Ltd: Carving a niche
INDUSTRY UPDATE Ortho Biotech Products 7%
Baxter 5%
IT & automation: The key to excellence in pharma
Others 23% BMS 15%
Sanofi-Aventis 22%
54
MARKET TRENDS OTC marketing & branding: Reshaping the strategies
34 38 42 48
Amgen 28%
57
REGULAR SECTIONS
MARKETING The next level of pharma marketing: Keeping the patient at the forefront Dr Rajan T D Pharma Consultant and Practising Dermatologist
54
Editorial ............................................................. 13 National News................................................... 16
INDUSTRY OUTLOOK
World News....................................................... 22
Blood disorders therapeutics market: A promising pipeline Courtesy: GBI Research
Tech Updates ..................................................... 28 Events Calendar ................................................ 61
INDUSTRY INSIGHTS
Book Shelf ......................................................... 63
Pancreatic cancer drugs market: Need for more and better drugs Courtesy: GlobalData
Fresh Arrivals .................................................... 64
57 60
Product Update................................................. 66 Product Inquiry ................................................ 75 Advertisement Inquiry ..................................... 77 Product Index ................................................... 79 Advertisers’ List................................................. 80
Highlights of Next Issue Sector Watch: Pharma manufacturing Market Trends: Pharma outsourcing/CRAMS Industry Update: R&D in pharma Note: $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise
14 Modern Pharmaceuticals
July 2010
NATIONAL NEWS
NEW DEVELOPMENT
Ranbaxy transfers new drug R&D unit to parent firm Daiichi Sankyo Recently, Ranbaxy Laboratories transferred its new drug discovery research unit to its Japanese parent company Daiichi Sankyo. Ranbaxy and Daiichi Sankyo India Pharma Pvt Ltd will merge their Research & Development (R&D) systems into Daiichi Sankyo Life Science Research
NEW VACCINE
Wyeth launches pneumonia vaccine Prevenar 13
L-R: Kewal Handa, Farah Khan, Dr Nitin Shah
Wyeth, a subsidiary of Pfizer, Inc in India, launched Prevenar 13, an advanced
ACCOLADE
Elder Pharmaceuticals awarded India’s Most Watched Company, of 2010 Elder Pharmaceuticals Ltd has received the India’s Most Watched Company of the Year 2010 award at the 3rd Annual Pharmaceuticals Leadership Summit 2010 held recently in Mumbai. The award highlights the scientific accomplishments in the industry and academic pharmaceutical research. The
QUALITY ASSURANCE
Quality seal assures product excellence
SCHOTT has developed a quality seal to facilitate the use of superior quality glass tubing in India’s pharmaceutical and biotech industry. As primary pharmaceutical packaging is an integral
16 Modern Pharmaceuticals
Centre. Daiichi Sankyo will now conduct new drug research operations, while Ranbaxy will retain the R&D functions related to generic drugs. “Within Ranbaxy, R&D of generics will gain a sharper focus, as we are increasingly working on more complex and specialist areas,” said Atul Sobti, CEO, Ranbaxy. However, the most important molecule by the company, the new antimalarial drug, Arterolane + PQP, currently
in Phase III trial, will stay with Ranbaxy. The company would independently develop and later commercialise the drug. The transaction has been approved by the Department of Scientific and Industrial Research, Ministry of Science and Technology, Government of India.
pneumococcal conjugate vaccine, with an aim to protect infants and young children from pneumococcus, a bacterium that causes pneumonia, meningitis and sepsis. “Prevenar 13, built on the scientific foundation of Prevenar, provides the broadest serotype coverage of any pneumococcal conjugate vaccine,” said Kewal Handa, Managing Director, Wyeth. Prevenar 13 covers serotypes 1 and 5, which are associated with complicated pneumonia, as well as serotype 19A,
which has globally emerged as a leading cause of pneumococcal disease in children of age below five years. “Prevenar 13 covers 75 per cent of disease-causing serotypes in India. Preventing this group of diseases is important for two reasons — pneumococcal diseases are difficult to diagnose in the Indian context and the bacteria are developing resistance to antibiotics,” said Dr Nitin Shah, Consultant Paediatrician, PD Hinduja Hospital, Mumbai.
summit was organised by Pharmaleaders Magazine & Indo-American Chamber of Commerce. K Sankaranarayanan, Governor of Maharashtra, conferred the honour on Jagdish Saxena, Chairman, Elder Pharma, in the presence of Manoharrao Rajusingh Naik, Minister of Food & Drugs Administration (FDA), Maharashtra. Elder Pharmaceuticals Ltd began its operation in 1988, and has carved a niche in therapeutic segments like wound
care, women’s healthcare, vitamin and nutraceuticals supplements, diabetes, cardiology, dermatology, antibiotics and central nervous system. Calcium supplements like Shelcal, wound healing and injectable vitamin B12 are also a part of this company.
part of the drug, the requirements for vials, cartridges, ampoules and syringes must meet the highest international standards. The quality seal assures that the pharmaceutical containers are made of high-quality SCHOTT glass tubing. The trademark ‘Manufactured out of SCHOTT Glass Tubing - Quality & Reliability’ can be used in all communications with pharmaceutical companies to create a clear advantage over the competition.
Further, it can be used as a package sticker, in print and online advertisements, websites & brochures, along with public relation activities as well as marketing materials for trade fairs. “Our trademark will help converters to show that premium quality material are used to manufacture their packaging solutions,” said Mohan Joshi, President, SCHOTT Glass India Pvt Ltd.
July 2010
NATIONAL NEWS
CLINICAL TRIAL
Bhopal Memorial Hospital turns hot spot for clinical trials on untested drugs by MNCs The Bhopal Memorial Hospital and Research Centre (BMHRC) was set up to provide super-speciality treatment to survivors of the Bhopal gas tragedy and conduct research on long-term effects of Methyl Isocyanate (MIC). However, instead of working on MIC-related
CONFERENCE
DoP’s convention biopharma in New Delhi
on
Courtesy: www.hgpauction.com
Recognising the potential role of biopharma in future healthcare, the Department of Pharmaceuticals (DoP) recently organised a
REGULATION
Industry urges Government to remove clause on ‘Patent status’ in Form-44 of D&C Rules The Indian pharmaceutical industry has urged the Union Health Ministry to remove the clause relating to the ‘Patent status of the drug’ from the Form-44 of Drugs and Cosmetics Rules on the plea that it favours only the patent holder to delay the entry of a generic drug in the market.
DE-MERGER
Alembic plans to de-merge business
Alembic Pharma Ltd is planning to de-merge the business into two companies. The individual entities with separate management
18 Modern Pharmaceuticals
issues, the hospital has over the years been conducting clinical trials on untested drugs that were primarily designed to help pharma companies, said a press release. “Except fondaparinux, other agents tested in Bhopal were all New Chemical Entities (NCEs) or investigational new drugs that have not been approved for human use elsewhere. Consequently, their side-effects, morbidity and mortality were not fully known
when the trials begun in Bhopal,” said Dr CM Gulhati, Medical Expert & Editor, Monthly Index of Medical Specialities (MIMS).
one-day ‘National Convention on Biopharma’ at the Federation of Indian Chambers of Commerce and Industry (FICCI) House, New Delhi. The event saw participation from Department of Biotechnology (DBT) in partnership with FICCI and the support of Association of Biotechnology Led Enterprises (ABLE). The convention brought together stakeholders and the government to discuss the areas of facilitation in the industry and government support in order to bridge
the gaps for acknowledging the potential leadership of the Indian biopharmaceutical industry. The convention had speakers from academia, industry and government to share their experience and highlight issues. Currently, biotechnology drug candidates account for over 30 per cent of all pipeline research programmes. Indian biopharmaceutical industry and the government should collaborate to identify and address key issues and challenges to lead the global market.
Form-44 of the Drugs and Cosmetics Rules, submitted to the Drug Controller General of India (DCGI) for grant of permission to import or manufacture a new drug or undertake a clinical trial, has the clause on ‘Patent status of the drug’. The industry has requested the government to remove this clause from the Form-44, as it is associated with the principle of ‘patent linkage’. Patent linkage is a practice followed in some countries like the US, which favours the
patent holder to delay the entry of a generic in the market. However in India, the DCGI is not authorised to examine the patent status of a drug, but is to be decided by the courts.
teams will focus on growth opportunities and objectives in their respective business. While Alembic Pharma Ltd will be undertaking generics business, domestic formulation, the Alembic Ltd will include Vadodara undertaking, power and real estate assets. This initiative aims to draw distinct set of investors, both financial and strategic, for different businesses. Under the scheme of arrangement of
the Companies Act, 1956 shareholders of Alembic Ltd will receive additional shares in Alembic Pharma Ltd in the ratio of 1:1. The appointed date for the de-merger was April 1, 2010, however, since the company is likely to get approvals from stakeholders, creditors, High Court and other regulatory authorities, the process is likely to take about 7-9 months.
July 2010
Bhopal Memorial Hospital
Courtesy: www.murciascubadivingclub.com
NATIONAL NEWS
TAX REGULATIONS
Pharmexcil pleads centre to continue IT exemption for SEZs in DTC regime The Pharmaceutical Exports Promotion Council (Pharmexcil) has requested the finance ministry to continue the income tax exemption offered through the Special Economic Zone (SEZ) Act, 2005, to all new SEZ developers and units
MARKET RESEARCH
Pharma firms likely to hit 20 per cent top line growth
Investors in pharmaceutical stocks, having a total market capitalisation of Rs
NEW DRUG
Indian pharma companies launch breast cancer drug in US Natco Pharma, Zydus Cadila and Dr Reddy’s recently launched in the US market, a generic version of Anastrozole, a drug for breast cancer treatment. These firms have launched their respective products in the strength of one mg after approval from the US Food and Drugs Administration (USFDA). According to the research firm IMS, PRE-CLINICAL STUDIES
AVESTHAGEN completes preclinical efficacy trial for AVENT™
Avesthagen has completed its pre-clinical efficacy trial for one of its biosimilars drugs AVENT™ at Biomedcode Hellas S.A.
20 Modern Pharmaceuticals
even after the implementation of the Direct Tax Code (DTC). It has asked the ministry to consider the efforts of the pharmaceutical firms in setting up new units in the SEZs. Under the proposed DTC, the Grandfather provision, a clause that allows an old rule to continue to apply to some existing situations when a new rule will apply to all future situations of income tax exemption have only been
provided to the developers of the SEZs and the units that were operational before March 31, 2011. This decision was taken after continued requests from the SEZ community, after a draft of discussion paper was published earlier.
270,000 crore, can expect at least 20 per cent year-on-year growth in top lines in the first quarter of the current financial year. Thus, companies like Sun Pharma, Lupin and Glenmark are expected to lead the large-cap group. Analysts expect this growth to be driven by product launches in the US, a strong growth in India and higher penetration in emerging markets. However, firms under the pharma Contract Research and Manufacturing Services (CRAMS), eg,
Dishman, Jubilant and Divis Laboratories, are believed to have experienced bottlenecks in the US and European Union in the April-June quarter. Sun Pharma is expected to post about 25-26 per cent growth in top line and substantially high net profit due to lower raw material and business costs at Caraco, its US unit. The boost from branded business is expected to improve Lupin’s status, while Glenmark is expected to show improvement on a lower base to show over 40 per cent top line growth.
the market for Anastrazole, patented by AstraZeneca and sold as Arimidex, is about $ 1 billion in the US. Natco Pharma launched the drug in the US through its marketing partners and is confident of gaining a reasonable marketshare. Zydus Cadila also launched the drug in the strength of one mg after the USFDA approval. Thus, the company now has 56 approvals from the US health regulator. It has also filed 113
Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY2003-04. On June 28, another Indian firm, Dr Reddy’s, launched a generic version of Anastrozole, available in 30 count bottles, in the US market.
AVENT™ is recommended for alleviating symptoms in patients with moderate-to-severe rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. The pre-clinical efficacy trial of AVENT™ was carried out in a human Tumour Necrosis Factor (TNF) transgenic murine model for rheumatoid arthritis, and was accredited by the US Food and Drug Administration (USFDA).
Avesthagen has successfully developed a proprietary expression vec tor cell line by using this technology. This product is currently being scaled-up for the clinical trials at Inno Biologics facility in Malaysia. Dr Villoo Morawala Patell, CMD, Avesthagen Ltd, said, “Avesthagen is making progress in its biosimilars programme as per schedule in order to provide cost-effective healthcare solutions.”
July 2010
NATIONAL NEWS
R&D
Pharma research outsourcing faces bottlenecks Suven Life Science entered the last major new drug discovery collaboration deal more than two years ago with Eli Lilly for pre-clinical research of molecules for use in central nervous system disorders. However, Venkat Jasti, Vice-Chairman and Managing Director, Suven Courtesy: www.biojobblog.com Life Sciences, said, “Deals will come as they do not happen overnight.� Major drug discovery outsourcing deals have almost disappeared in the past 18 months for most prominent players in the area, eg, GVK Bio, Advinus Therapeutics, Biocon, Jubilant Organosys and Piramal Lifesciences. The Tata Group-promoted Advinus Therapeutics, a company for new pure drug discovery in India, had also signed its last drug discovery and development collaboration in September 2008. Although these companies had formed major drug discovery alliances with companies like Eli Lilly, Wyeth, Merck, Bristol-Myers Squibb and GSK in 2006-2008, no new developments were seen since then. MARKET GROWTH
Domestic formulations market to grow 12-14 per cent: Anagram The Indian pharmaceutical industry was estimated to be $ 19.4 billion (including exports) in 2008-09. The per capita annual drug expenditure in India was about $ 3 compared Courtesy: www.sciencedaily.com with $ 412 and $ 191 in Japan and the US, respectively, indicating the extent of growth opportunity in the domestic market. The domestic formulations market is also expected to grow 12-14 per cent over the next few years, due to increasing chronic and lifestyle-related diseases, which would outpace the industry growth rate. Generics business is the crux of Indian pharmaceutical business due to India’s low-cost manufacturing advantage, high degree of regulatory compliance, well-established presence across the globe, increasing generics penetration and patent expiries. Further, large innovators are increasingly focussing on generics to maintain their growth momentum and revenue share, with diminishing innovative product pipelines and no major products available to support the expiring patents.
July 2010
Modern Pharmaceuticals
21
WORLD NEWS
NEW PRODUCT
GW Pharma launches Sativex in the UK Sativex®, an oromucosal spray for the treatment of spasticity caused by Multiple Sclerosis (MS), was recently launched by GW Pharmaceuticals plc in the UK. The drug is considered the world’s first prescription-only cannabis medicine and UK is the first country in the world to grant a full regulatory authorisation for the product.
APPROVAL
Watson Pharma receives tentative approval for fentanyl buccal tablets
Watson Laboratories, Inc, a subsidiary of Watson Pharmaceuticals, Inc, has
DRUG AUTHORISATION
Nutra Pharma begins registration process for Nyloxin Nutra Pharma Corp, a biotechnology company involved in developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has initiated the drug registration process in Panama for its pain reliever Nyloxin. Nyloxin, first introduced in November 2009 as a treatment for chronic pain, is currently available in the US as an
CLINICAL TRIAL
Eurocor showcases eluting balloon to cardiologists
drug Asian
Eurocor GmbH, German subsidiary of Opto Circuits India, hosted two live cases and a successful symposium on
22 Modern Pharmaceuticals
Sativex® contains two cannabinoids or active ingredients, namely, delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD) derived from whole plant extracts of the Cannabis sativa plant. Sativex® will help relieve spasticityassociated spasms and cramps in patients with MS, as it has been shown to improve symptoms in cases where current treatments have failed. Sativex® is currently manufactured by GW under a home office licence at an
undisclosed location in the UK. It is being marketed in the UK by Bayer Schering Pharma – UK licensee of GW.
received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for fentanyl citrate buccal tablets, with dosage strengths 100, 200, 300, 400, 600 and 800 µg. Watson’s fentanyl citrate buccal tablets are a generic version of Cephalon’s Fentora® used to treat breakthrough pain (sudden episodes of pain that occur despite regular intake of pain medication) in cancer patients who
are regularly taking another narcotic (opiate) medication for pain. The legal action by Cephalon against Watson alleging that Watson’s ANDA for fentanyl citrate buccal tablets infringes some of Cephalon’s patents is pending. Final approval of Watson’s application remains subject to the expiry of the automatic stay of approval imposed under the provisions of the HatchWaxman Act.
oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia, and as a topical gel for treating joint pain and pain associated with repetitive stress and arthritis. “As an important international business centre, Panama offers us an opportunity to introduce our pain reliever Nyloxin in Central America. We shall move forward with the drug registration process along with finalising our relationship with a prospective
local distribution partner that has the resources and capabilities to successfully market and distribute Nyloxin across the country,” said Rik J Deitsch, Chairman & CEO, Nutra Pharma.
the concept of a Drug Eluting Balloon (DEB) – DIOR PTCA catheter, at the 6th Asian Interventional Cardiovascular Therapeutics (AICT) 2010 in Singapore. Dr Peter Stella from Netherlands presented the data from the Drug Eluting Balloon In Bifurcation Trial (DEBUIT) on the application of DIOR in the treatment of bifurcation lesions. DEBUIT is a multi-centre clinical study and the study results showed significant
clinical advantages provided by DIOR in bifurcated lesions. Speaking on the Asian market, Sreerangan Kurup, Managing Director, Eurocor GmbH said, “The cardiovascular device segment in South-east Asia has been growing at a rate of 10-15 per cent. AICT has provided us with an excellent platform to showcase our European experience and technical know-how in the market.”
July 2010
WORLD NEWS
ALLIANCE
AstraZeneca, MMV collaborate to identify novel malaria treatments AstraZeneca and Medicines for Malaria Venture (MMV) recently collaborated to identify novel candidate drugs for the treatment of malaria. As per the agreement, scientists working with MMV will screen 500,000 compounds in AstraZeneca’s unique library for activity against Plasmodium falciparum, the most lethal of malarial parasites. Prof V Avery at
JOINT VENTURE
Sanofi-Aventis, JDRF partner to develop new type I diabetic drugs
Sanofi-Aventis and Juvenile Diabetes Research Foundation (JDRF) recently
INVESTMENT
Shire buys strategic site in Massachusetts Lexington Technology Park campus in Lexington, Massachusetts, was recently bought by Shire Plc, a global specialty biopharmaceutical company. This investment is towards the growth of Shire’s Human Genetic Therapies (HGT) business, which focusses on the discovery, development
ACCORD
Eisai and Arena Pharmaceuticals collaborate for lorcaserin
Courtesy: Obesity Eating Disorder
Eisai, Inc, the US pharmaceutical operation of Tokyo-based Eisai Co Ltd, has collaborated with Arena Pharmaceuticals
24 Modern Pharmaceuticals
the Eskitis Institute for Cell and Molecular Therapies, Griffith University, Brisbane, Australia, will carry out the screening on behalf of MMV. Promising compounds identified through the screening process will act as starting points for anti-malarial drug discovery projects. These compounds will then progress through a discovery cascade at AstraZeneca’s Research and Development (R&D) facility in Bengaluru, India, aiming to identify suitable candidates for clinical testing.
David Brennan, CEO, AstraZeneca, said, “Opening our compound library to MMV is an important step towards addressing the enormous unmet medical needs of the developing world. “
partnered to develop therapeutic treatments for patients with type I diabetes as well as to prevent diabetes in those at risk. Under the new partnership, SanofiAventis and JDRF will jointly provide funds to academic investigators and non-profit medical research organisations to conduct research in regeneration and immune therapy. This partnership will
also provide Sanofi-Aventis with options for the intellectual property generated by researchers who receive funding through the programme. “Our partnership with the JDRF is an opportunity to help fund innovative research that will improve therapies and perhaps even find a cure for type I diabetes,” said Pierre Chancel, Senior VicePresident - Global Diabetes, Sanofi-Aventis.
and manufacture of treatments for rare genetic disorders. The company had previously leased three buildings on the 96-acre campus, and owns the portion of land on the site where its new 2,00,000 sq ft manufacturing plant is located. The purchase agreement is for the remaining land, including the three existing buildings spanning 2,80,000 sq ft. Through the purchase, Shire will gain ownership of an additional 5,70,000 sq
ft of expansion potential available under the current permit, including 1,70,000 sq ft already under construction. Further, the purchase is value enhancing as compared with the current lease agreement and has no material earnings impact, said the press release.
GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc, for exclusive US rights to commercialise lorcaserin, a potential drug candidate for the treatment of obesity for patients with Body Mass Index (BMI) of 27-30, and at least one weight-related co-morbid condition. If approved by the Food & Drug Administration (FDA), Eisai will market and distribute lorcaserin in the US and Arena will handle the manufacture & supply of the finished commercial product at its facility in Switzerland.
“Obesity is one of the most pressing public health issues of this day, which cannot be overlooked. As part of our human health care (hhc) mission, Eisai is committed to increase benefits to patients and their families by addressing their unmet medical needs. Through this agreement, Eisai can now bring a new option to market to address the significant and growing need for medical treatments for obesity,” said Lonnel Coats, President & CEO, Eisai Inc.
July 2010
WORLD NEWS
GRANT
Japan contributes $ 10 million for AIDS vaccine R&D The Government of Japan has recently pledged a $ 10 million grant for AIDS vaccine Research & Development (R&D) to the International AIDS Vaccine Initiative (IAVI) in the next five years. The grant will be channelled to the IAVI through a newly established World Bank trust fund. “We are extremely grateful to Japan for its generous contribution to AIDS
NEW FACILITY
Vertellus Specialties, Inc, expands production capacity
Vertellus Specialties, Inc, is expanding the production unit for 3-cyanopyridine at Vertellus, its production facility in Nantong, Jiangsu, China. This unit will
INVESTIGATION
Promising melanoma pipeline and opportunities for drug developers In a recent report, Datamonitor predicted a near doubling of melanoma cases by the end of the decade from an estimated 1,38,000 new cases in the current year to 2,27,000 new cases by 2019 as a result of continued exposure to risk factors. Tom Gray, Senior Healthcare Analyst, Datamonitor, commented, “A significant
ACQUISITION
Orchid to acquire US-based Karalex Pharma
Orchid Chemicals & Pharmaceuticals Ltd is all set to acquire Karalex Pharma, LLC, a US-based generic marketing and sales
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vaccine R&D, and also to the World Bank for its untiring support to the IAVI and the fight against HIV/AIDS,” said Seth Berkley, President & CEO, IAVI. The IAVI, in collaboration with its Japanese partners, will continue to advance an AIDS vaccine candidate that is constructed using a paramyxovirus known as the Sendai virus. Viral vectors based on the Sendai family have the potential to elicit a durable and highly targeted immune response in mucosal tissues, where HIV often
establishes infection before amplifying and spreading. Since 2001, the IAVI has been working with Japan to mobilise resources to support the development of AIDS vaccine, which is expected to soon enter Phase I testing in humans.
increase the company’s vitamin B3 manufacturing capacity in the region by 10,000 metric tonne. Vertellus’ new vitamin B3 plant in Nantong will incorporate the latest, most efficient and environmentally sound technologies available, thus enabling the company to maintain its cost leadership position in vitamin B3 manufacturing. Vertellus also plans to construct a niacinamide/niacin production unit for Vitamin B3, also in Nantong.
“This project is a milestone in Vertellus’ China growth strategy and will be a key part of our growing global infrastructure. The demand for Vitamin B3 and 3-cyanopyridine has increased significantly worldwide and particularly in Asia. We intend to meet this demand, and thus, have developed an aggressive strategic plan to grow our presence in the region,” said Rich Preziotti, CEO, Vertellus Specialties, Inc.
unmet need remains for more effective drugs, which makes melanoma a popular Research and Development (R&D) target. While this has yet to translate into novel, effective therapies, several promising candidates in latephase development can change the face of melanoma treatment.” According to the new report, while no major breakthroughs with cytotoxic agents or cytokines have been made in the last three decades, the next
generation of systemic treatment will include compounds that target specific molecular pathways, which may or may not be unique to individual patients.
services company headquartered in New Jersey, USA, through an all-cash deal for an undisclosed amount. Through this acquisition, Orchid plans to make its presence felt in the front-end US market and will be able to directly provide its generic products to the US customers. “We are pleased to have established our presence in the generic sales and
marketing area with this acquisition. This acquisition will provide a strong commercial US-based sales capability to Orchid, paving the way for synergistic returns from our upcoming and longterm strategic generic pharmaceuticals pipeline comprising key first-to-file and paragraph-IV products” said K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals Ltd.
July 2010
WORLD NEWS
STRATEGIC DEAL
Astellas acquires OSI Pharmaceuticals for $ 4 billion Astellas Pharma, Inc, recently announced its $ 4 billion acquisition of OSI Pharmaceuticals, Inc. OSI is a biotechnology company primarily focussing on the discovery, development and commercialisation of molecular targeted therapies that address medical needs in oncology,
FDA APPROVAL
FDA approves APP Pharma to market aztreonam for injection
The US Food and Drug Administration (USFDA) has approved APP Pharmaceuticals, Inc, a wholly
diabetes and obesity. The company also manufactures and sells Tarceva (erlotinib), a cancer drug, and is also reported to have several prospective new oncology medications in its Research and Development (R&D) pipeline. Masafumi Nogimori, President & CEO, Astellas, said, “We are pleased to announce the completion of this transaction with OSI. We are enthusiastic for the opportunities arising from this acquisition
and look forward to working with OSI. This transaction marks an important step forward for Astellas as the company works towards developing a world-class oncology platform and realising our goal of improving the health of people worldwide.”
owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc, to market Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam®, marketed by Bristol-Myers Squibb. Aztreonam is indicated for the treatment of infections caused by susceptible gram-negative microorganisms. APP will launch
Aztreonam immediately in single dose vials of 1 gm, 20 mL and 2 gm, 30 mL. Also, it is AP-rated, bar-coded & latex-free. The recent approval will expand APP’s leading anti-infective product line. “The approval of APP’s Aztreonam marks entry of the first generic into the market and provides clinicians with an alternative to the branded drug,” said John Ducker, President and CEO, APP Pharmaceuticals.
July 2010
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TECH UPDATES
Perceptive Informatics upgrades its medical imaging capabilities
New HPLC columns and column oven expand the research reserve
Perceptive Informatics, one of the leading eClinical solutions providers and a subsidiary of Parexel International Corporation, is expanding its medical imaging capabilities. It has enhanced its medical imaging reporting solution, which includes wideranging online interactive reports that deliver data on study progress with interactive functionality. This will allow users to find out various aspects of tracking performance. A key feature of this new solution is a dashboard with high-level imaging performance metrics to convey vital study information in brief. The dashboard enables study leaders to view snapshots of the study progress for rapid analysis of data. User-friendly graphical displays provide visibility into the Key Performance Indicators (KPIs) and enable centralised access to imaging metrics for multiple trials and monitor cross-study programmes. “The stakeholder groups within imaging-based clinical programmes have diverse information needs, which Perceptive is committed to meet by continually enhancing our technological capabilities,� stated Dr Kenneth G Faulkner, Vice President,-Medical Imaging, Perceptive Informatics.
A series of new High Performance Liquid Chromatography (HPLC) columns and a new column oven are now available for analytical researches. Thermo Fisher Scientific, Inc, (Milford, MA, USA) has recently begun to market five new phases of HPLC columns introduced in its Hypersil Gold line, thus increasing the number of different types of columns to 11. The five new phases are Hypersil GOLD C4, amino column, AX, SAX and silica. All the columns use the same backbone of pure silica to deliver exceptionally symmetrical peak shapes, regardless of the compound tested or the mode of analysis. Thermo Fisher Scientific recommends the new column ovens, which complements the new chromatography columns that come in two specifications: column oven 200 and column oven 300. The temperature control unit is designed for simple manual control of the column temperature or alternatively, optional drivers can be used to control the column oven through the instrument Hypersil GOLD HPCL column software.
Automated cell migration system to enhance drug development process
NQAD universal detector offers near nanogram sensitivity
Essen BioScience, Inc, has released its CellPlayerTM cell migration 96-well assay kit as an add-on to its IncuCyteTM live-cell imaging system. IncuCyteTM is a compact automated microscope positioned inside a standard tissue culture incubator. This microscope enables studying all aspects of cell migration, especially the way in which it is affected by candidate drug compounds. The CellPlayerTM cell migration 96-well assay offers a precise and reproducible label-free method for monitoring key biological processes in cell migration. This kinetic assay features automated data collection within hours or days and generates datasets optimal for studying pharmacological agents and gene-silencing technologies for this important function. Software built into IncuCyteTM automates the data collection process and subsequently analyses the cell migration assay. The CellPlayerTM cell migration assay can provide precise and reproducible data for the study of cell migration. The expanding line of kinetic CellPlayerTM assays for the IncuCyteTM also includes a co-culture IncuCyteTM live-cell imaging system assay for angiogenesis.
An ultra-sensitive, universal Nano-Quantity Analyte Detector (NQAD) presents a major advancement in High-Performance Liquid Chromatography (HPLC) detection capability. It is a new and completely different type of aerosol-based detector for HPLC. It was developed by Dorton Analytical, and it offers the ability to detect subnanogram levels through condensation nucleation technology. The NQAD also offers a wide dynamic range with superior linearity compared with other aerosol-based detectors. The detection by NQAD is near universal for compounds that are less volatile than the mobile phase. Chromophores and fluorophores are not needed for detection. The detector is optimised for use in Ultra HighPerformance Liquid Chromatography (UHPLC), HPLC and Supercritical-Fluid Chromatography (SFC). Due to its ultra-high sensitivity, the detector is suitable for searching drug impurities, degradation products and excipients, where industrial hygiene is a concern. The detector can accurately quantify compounds that were previously both easy and difficult to measure and requires minimal sample Nano-Quantity Analyte Detector preparation.
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TECH UPDATES
Olympus zero drift microscope offers continuous autofocus for time-lapse imaging
A new second-generation Poly-Adenylyltransferase-Ribose Polymerase (PARP) in vivo pharmacodynamic assay is being used to document differences in PAR levels in human tumour lysates from a variety of tissues, organs and xenografts. It accurately measures net Poly-Adenylyltransferase-Ribose (PAR) levels in cellular extracts. PARP is a protein involved in numerous cellular processes including catalysing the Nicotinamide Adenine Dinucleotide (NAD)-dependent addition of PAR onto itself and other adjacent nuclear proteins. PARP-1 is widely regarded as a promising target for the development of drugs useful in various regimes of cancer therapy, inflammation, ischaemia and neurodegeneration. PARP in vivo pharmacodynamic assay from AMS Biotechnology (Amsbio) uses a validated sample processing regime and a chemiluminescent, sandwich Enzyme-Linked Immunosorbent Assay (ELISA) format, with pre-coated 96-stripwell plates. The assay reports PAR level with high signal-to-noise ratio, sensitivity of two pg/mL and a linear dynamic range up to 1,000 pg/mL. It offers an exciting new application that provides evidence of drug action on molecular targets and generates baseline values that may be used to stratify patient response to therapy.
The Olympus IX81-ZDC zero drift microscope system provides a complete autofocus imaging solution for investigators working on time-lapse experiments by using inverted microscopes. It uses a class 1 laser diode of wavelength 785 nm to locate the uppermost surface of the specimen’s cover slip, multi-well tissue culture plate, glass bottom culture dish or other glass substrate. Using the SlideBook™ software, the system automatically moves to a user-defined focal plane relative to the cover slip and maintains specimen focus for extended periods. The objectives of Olympus are designed for multi-wavelength time-lapse imaging, with chromatic correction in the range 330–1100 nm, according to individual objectives. The zero drift system is integrated into the Olympus IX81 microscope stand. The system can be used for applications like TIRF, high-throughput screening and other high-accuracy, timelapse studies of living cells in stage incubation Olympus IX81-ZDC zero drift microscope system systems.
New web-based study design tool in DataLabs EDC solution by Perceptive Informatics
Thermo Fisher Scientific’s new kits promote RNAprotein studies
A new web-based version of the DataLabs Designer™ module was recently released by Perceptive Informatics, which is part of Perceptive’s DataLabs® Electronic Data Capture (EDC) solution. Perceptive Informatics is one of the leading eClinical solutions providers and a subsidiary of Parexel International Corporation. The DataLabs® EDC solution is part of Perceptive’s eClinical Suite that provides interoperability among systems, including the IMPACT® Clinical Trial Management System (CTMS) and ClinPhone® RTSM technologies. The eClinical Suite is a dramatic shift towards maximally leveraging technology to accelerate development. The suite supports real-time data interchange, simplifies workflow and enables diverse applications to work synergistically while facilitating effective trial management. “Optimising the trial process is a priority for the biopharmaceutical industry. The DataLabs Designer tool was developed with the flexibility to be implemented in the customer’s environment or hosted by Perceptive,” said David Stein, Senior Director, Product Management, Perceptive Informatics.
Two related self-contained kits allow molecular biologists to probe RNA-protein complexes using a modernised version the RNA Electrophoretic Mobility Shift Assay (EMSA) technique that replaces radioactive labelling with chemiluminescent detection. The kits are manufactured by two subdivisions of Thermo Fisher Scientific, Inc, the LightShift RNA EMSA kit and the Pierce RNA 3’ end biotinylation kit. The LightShift RNA EMSA kit, based on a biotinylated RNA fragment used to probe protein samples, is the first commercially available EMSA kit. RNA-protein complexes are then monitored by changes in electrophoretic migration patterns. To detect these changes, a chemiluminescent detection method is used that provides sensitivity comparable to detection of a radioactive label. The second kit, Thermo Scientific Pierce RNA 3’ end biotinylation kit, makes the in-house preparation of biotinylated probe easy. This kit provides the reagents required to produce biotinylated RNA probes for use in chemiluminescent or other detection methods. The biotinylated RNA probes produced in-house cost much less than commercial biotinylated RNA probes.
Courtesy: Realwire Ltd
AMSBIO designs tools to study genomic instability
DataLabs® by ClinPhone®
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TECH UPDATES
Lightweighting & cost saving potential, as Mocon upgrades WVTR line Converters and manufacturers will be able to measure the real-life performance of packaging barrier products with greater speed and accuracy by using an enhanced water vapour transmission rate (WVTR) instrument, according to Mocon Inc. The US-based company revealed that the upgraded version of its Permatran-W Model 3/33 Plus, launched globally, has the capability to automatically measure relative humidity (RH). RH significantly impacts the water vapour transmission rate of many materials. “Newly developed software in the equipment will help packaging companies to achieve precise relative humidity conditions that are critical in understanding how barriers will perform in real-world conditions,” said Mocon. The Permatran-W series tests the WVTR of films as well as finished flexible and/or rigid plastic-based packaging. “Data gathered from testing will provide specific performance information which, in turn, can be used to modify material parameters,” said the company. This would result in material source reduction and cost-savings. This development makes achieving and controlling a critical variable related to barrier performance simpler and faster, Mocon added.
Brightest X-ray machine to probe molecules The Stanford [University] Linear Accelerator Centre is a major laboratory for conducting experiments in the field of biology and medicine. The electron acceleration equipment has been adapted over the past few years to create something known as the Linac Coherent Light Source (LCLS) that produces short X-ray pulses millions of times brighter than those currently created by other instruments. The brightest X-ray machine operates with photon energies in the ‘hard X-ray’ region and high beam intensities of 1,018 W/cm2. At these energies, the machine can serve as an extraordinary microscope for viewing matter at the scale of atoms. This technology will act like a knife since it can peel electrons away from the parent atoms and molecules, and even those in close proximity to the nucleus. The first experimental results from the LCLS have now started appearing at scientific meetings. Dr Li Fang of Western Michigan University reported on how the powerful LCLS X-rays can be used to strip electrons away from a nitrogen molecule, at the 2010 Conference on Lasers and Electro-Optics/Quantum Electronics and Laser Science Conference (CLEO/QELS). Further studies in future should give investigators a more accurate assessment of large molecules like the biomolecules. 32 Modern Pharmaceuticals
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NMR technology aids in drug design Scientists are using Nuclear Magnetic Resonance (NMR) to help in the drug design field, which provides insights into the dynamic flexibility of drugs and their targets. The research that was conducted by a team of researchers led by Dr Jeffrey Peng, Assistant Professor, Department of Chemistry and Biochemistry, University of Notre Dame, was published on April 28, 2010, in the Journal of the American Chemical Society. The research shows the growing awareness towards the shape-shifting movement of molecules, a characteristic that potentially could help drug designers overcome issues of resistance, transportation of drugs to targets and oral bioavailability. Dr Peng reported that the study of Flexibility-Activity Relationships (FARs) adds another dimension to the longstanding Structure-Activity Relationships (SARs) that scientists have studied. Dr Peng said, “The new focus is that it is not enough just to look at the protein motion. Of course, we have studied protein motions for some time, as many disease-related proteins are flexible. But we have also realised that in order to impact drug discovery, we also have to look at the candidate drug molecule that is being designed, ie, the ligand. It can move too.”
NextPharma Göttingen adds tablet bottle filling line NextPharma has announced that its Göttingen facility, a centre of excellence for dry dosage forms, has added a new bottle filling line for tablets. This 45 metre ‘U-Form’ line is constructed with a completely separate primary area for filling and sealing, and secondary area for labelling and packaging. This new addition meets highest GMP/FDA standards and is a significant addition to the packaging technologies for solid dosage forms at NextPharma’s Göttingen site. This line, which has also been designed to serve the US market, can fill different forms of tablets, capsules and coated tablets into plastic and glass bottles of differing forms and sizes. Currently, the line is set up to provide six bottling formats and further formats can be added as required. Round or square bottles can be bundled or packed directly into boxes on the line and can be sealed with screwcaps or press-on caps with tamper proof or childproof sealings. The labelling unit can also provide a number of different formats including a printed Data-Matrix Code. Dr Hermann Osterwald, Managing Director, NextPharma Technologies, Contract Manufacturing Services (CMS), commented, “We are pleased to have added this new facility to our already extensive solid dosage manufacturing and packaging facility in Göttingen, which maximises further our flexibility to meet customer requirements.”
ROUNDTABL E
Pharma census in India
A step forward for better governance? The first pharmaceuticals census of India aims to create a pharmaceutical map of India, which will provide details of pharma manufacturing units across the country. In an interaction with industry experts, Saloni Vora tries to guage the impact of this endeavour, on planning and policy making. In February 2008, National Pharmaceutical Pricing Authority (NPPA) initiated a campaign with regard to First Pharmaceuticals Census of India (FPCI) to develop a comprehensive database that would incorporate important information on pharma manufacturing units like investment in plant & machinery, turnover of the units by class of industry, types of units (eg; formulation or bulk drugs), number of ‘own’ and ‘loan’ licences, state-wise and district-wise employment generated by the pharma sector in India, etc. It will also include details of the distribution of number of manufacturing units that have the World Health Organization-Good Manufacturing Practice (WHO-GMP) certification, units involved in exports along with the destinations of export, pattern of research & development (R&D) expenditure, and an outline of inventory of semi-finished goods, finished products. It is expected that this broad database would be utilised by the policy makers to facilitate better governance and planning. Now, one class of industry feels that this activity should be carried out more frequently (3-5 years) considering the dynamic and ever-evolving nature of the pharmaceutical industry. However, the manufacturers doubt on the fact that providing confidential information can be beneficial, as they believe that the NPPA may use the information against companies as price control even on common generics, making their products unviable in the market.
Dr Ajit Dangi President & CEO, Danssen Consulting The NPPA has taken a laudable step of conducting a pharmaceutical census and the resulting database will help policy makers to develop a long-term strategic plan for the development and sustainable growth of the Indian pharmaceutical industry. The industry has already made a global impact, and is emerging as a medicine basket for the world. As most governments in the developed world are under immense pressure to reduce healthcare costs, they are in turn looking towards countries like India and China for supplying good quality, affordable generics to their population. The NPPA should share the census database with other policy making bodies like DCGI, ICMR, DBT, NIPER, etc, as well
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as industry associations like OPPI, IDMA, Pharmexcil, etc, to identify gaps in their growth plans, and provide assistance in devising their strategies to remain competitive vis-a-vis other competing countries in this space. The database will also help MNCs and pharma SMEs to plan their investments in plant and machinery, technology, R&D as well as trained human resources. Besides generics, ancillary manufacturers of pharma machinery, packaging materials, Active Pharmaceutical Ingredients (APIs), intermediates, excipients, etc, will benefit enormously from the database to plan future expansion and investment plans. Moreover, the census will provide raw data, but the industry and the NPPA should work in unison to convert this data into meaningful information to enable planning and devising longterm strategies. While this census aims to provide comprehensive data for the first time, its effective utilisation will depend on the way the government and industry will analyse, interpret and ultimately use it for developing policies to make India an undisputed leader in the global pharma market by 2020.
ROUNDTABLE
Alok Saxena Director-International, Elder Pharmaceuticals Ltd India is a large country with the pharma industry spread throughout. However, there is a paucity of authentic data on the exact number of manufacturing units, their turnover, different types (formulation/bulk) as well as regionwise/state-wise break-up. Taking this scenario into account, this census will facilitate the generation of the pharma map of India, with information on various aspects such as investments, pricing & product specifications
Dipta Chaudhury Program Manager-Pharma and Biotech Practice, (South Asia and Middle East), Frost & Sullivan India being a highly fragmented market, with a large number of SME pharma manufacturers, this information is not readily available. Thus, it becomes difficult to track healthcare reforms, regulatory changes, investment in the sector, and growth of the industry. The pharma census thus can address these needs by providing decision makers an insight into the manufacturing hubs, their growth, infrastructural investments and their importance in the industry on a pan-India basis. The
Dr R B Smarta Managing Director, Interlink Marketing Consultancy Pvt Ltd The NPPA has taken an excellent initiative and more than 6,000 pharma units have responded to this call. This move will definitely help in upgrading the quality of medicines, as the collected data will highlight investments in different components of pharma manufacturing. Moreover, with the NPPA collecting information on formulation and bulk drugs as well, it will be able to justify
as well as compliance to GMP by drug manufacturers in the country. This is a progressive step to gain valuable insights into pharma manufacturing activities in the country, as it will allow the government & the industry to make plans and future policies. The census will generate extensive data on manufacturing, genderwise employment, capacity utilisations, state-wise distribution of manufacturing, consumption pattern of utilities, R&D expenditure, etc. This will help various ministries including Chemicals & Fertilisers, Health Ministry, Human Resource, Finance, etc. Further, information on the pattern of R&D expenditure will help understand the nature of research activities conducted in the country.
census will also help validate the current information on the pharma industry, and thereby confirm the growth and future prospects of this industry in India. The industry is eagerly awaiting the first pharma census, which would help in providing a fact basis for the current opinions of the industry. This information is valuable while making policy changes, as it would enable key decision makers to study the effects of previous policies and plan the impact of any changes they may make in the future. Also, it would provide an indicator towards states and regions in the country, which are intensive towards pharma. This information will further provide a database of WHO GMP compliant companies, their turnover, reach, etc, and will provide information guidance to ministries on the state of development of the industry and help align all manufacturing facilities towards following WHO GMP guidelines.
India’s position on the global scenario. The census will further clarify the various facilities approved by the USFDA, UKMHRA, etc, which have the capacity to produce high-quality generics. Also, proper positioning of this data will help Indian pharma companies to establish their presence in the US generic market in future. Next, state-wise classification of the data will provide direction to each state ministry and help them identify strengths of the respective states. Thus far, from other statistics, Andhra Pradesh has been noted to be leading in APIs, while Maharashtra & Gujarat are leading the formulations segment, and Karnataka on the biotechnology front. Such details can be especially tabulated from this census to strengthen each state to design specific strategies to empower its manufacturers.
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ROUNDTABL E
Piyush Tripathi General Manager-Sales, Chitra Pharma Machinery The NPPA was established on 29th August 1997 as an independent body of experts following the cabinet committee decision in September 1994 for reviewing the drug policy, monitoring the availability of drugs, identifying shortages, if any, and accordingly taking remedial steps. The NPPA is empowered to take final decisions, which are subject to review by the Central Government, as and when considered necessary. The Authority also monitors the prices of decontrolled drugs & formulations and oversees the implementation of the
Rajendra Pratap Gupta International Healthcare & Retail Expert The first pharma census is an interesting and important project undertaken by the Government of India. This project will provide vital insights to the policy makers and will redefine their approach towards this sector in the long term. Moreover, data obtained from this census may be immensely useful if collected for the past three years. The census details obtained by the NPPA may help in reviewing the following parameters: v New emerging units or old units undergoing closure or merger v Division and marketshare between large & SMEs in the pharma industry v Manufacturers involved in the production of life-saving and critical drugs followed by mapping the same, according to requirements in the country v Ratio of sales in domestic trade and exports by companies to help make the trade more competitive internationally
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provisions of the Drugs (Prices Control) Order. Keeping this mind, the census should be conducted as and when considered necessary, for that will help monitor the prices of decontrolled drugs and formulations, and oversee the implementation of the provisions of the drugs and price control order. Also, the government should establish a separate panel or committee of members having expertise in the field of pharmaceuticals, economics & cost accountancy, and the same should be entrusted with the task of price fixation revision and other related matters such as updating the list of drugs under price control by inclusion and exclusion on the basis of the established criteria/guidelines. Proper reporting in the census shall benefit not only centralised research reach but also give requisite source to new product development and requirement records, helping maintain a broader drug control.
v Percentage of the turnover spent on marketing, R&D, etc, wherein this information can be used for framing policies that can reduce cost of pharmaceutical products & boost R&D inputs from the pharmaceutical companies v Difference in the sale, pricing and marketing of generics & branded products v As lack of skilled manpower is a major deterrent for the growth of sector, and is a perennial problem for the Indian pharmaceutical industry, data obtained on employment & growth can be used to gauge the employment potential and capacity building for the sector Besides, one of the major inputs is that, the government can use the data to promote the SME sector and boost regulatory compliance of SMEs in pharma. Further, the data received will enable the government to bring in some pricing and profitability norms, which will reign in irrational prices for the common man. Hence, overall, the census is an excellent tool to increase the understanding, supervision, regulation & promotion of the sector and safeguard the interests of the industry to make it globally competitive, which will lead to logical & rational pricing for the common man. Also, this should become an annual exercise, as the pharma market is dynamic and the numbers & holding patterns change every year.
ROUNDTABLE
Tapan Ray Director General, Organisation of Pharmaceutical Products of India (OPPI) Currently, there is a pressing need for the pharmaceutical industry to generate a robust database to help formulate not only various healthcare-related policies but also to assist in measuring the level of their effective implementation. In the absence of such dependable and credible facts, most arguments taking place between the government and other stakeholders are mainly based on their individual views. Addressing this critical need, in February 2008, the NPPA announced its intent to initiate the FPCI. This activity will capture valuable information, which could be prudently used by the government towards effective planning, policy making and good governance. NPPA is also expected to publish the census data for all stakeholders and other ministries within the government for appropriate actions. The FPCI is expected to cover over 10,000 manufacturing units in the country in a well-structured manner so as to create an exhaustive healthcare-
T S Jaishankar Chairman, Confederation of Indian Pharmaceutical Industry and Managing Director, Quest Life Sciences The NPPA had made efforts in the past to conduct pharmaceutical census and create a comprehensive database. However, these efforts did not yield proper results. The Authority had circulated a questionnaire among all pharmaceutical manufacturers in India, most of which did not reply. The main reason for this was said to be complications in the questionnaire. Also, manufacturers do not think that providing confidential information can be beneficial, believing that the NPPA will use the information against companies as price control even on common generics, making their products unviable in the market.
related credible databank for India. Thus, this can provide credible details, among others, on the following 10 key areas of the Pharmaceutical Manufacturing Units (PMUs) to enable the policymakers to frame policies based on the ground realities and also measure the level of their effective implementations. v Turnover by types and class (micro, small, medium and large) v Locations with separate details of Export Oriented Units (EOUs) v Capacity installed, capacity utilised by major products v Number of ‘own’ and ‘loan’ licences units and by type of units, licence issued by the respective state drug controllers v Types, class and pattern (plant & machinery, land & building) of investments v Consumption of indigenous and imported inputs and utilities v Adherence to Good Manufacturing Practices (GMP) v Product types and pricing v Pattern of expenditure on R&D, clinical trials and quality control v Employment generated in the country by the pharma sector This is an admirable initiative by the NPPA and data generated will be immensely useful to all stakeholders, if updated in every 3-5 years to maintain their relevance.
Further, the industry does not consider the pharma census to be of much benefit. Thus, the NPPA must also clearly outline its objectives behind the FPCI with regard to the manner of utilisation of information generated and the personnel having access to these data. In fact, the government has all relevant information like the state-wise number of licensed manufacturers, number of employees per company, etc, through the state drug licensing authorities, Employee State Insurance (ESI) and PF departments. The government can easily access these departments to obtain relevant information, which can later be periodically updated. In order to strengthen the confidence of the industry, it is important for the government to announce the pharma policy as well as close the long pending issues of the role of NPPA and confine the price control in consultation with the industry associations. The government should thus encourage large investment in this sector, else India may lose out to China as the largest supplier of the generic drugs in the world.
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IN FOCUS
Fabtech Technologies International Pvt Ltd
Carving a niche
Prepainted panels for injectable moulding facility
Prepainted panels for OSD and liquid injectable
Powder coated panels for injectable facility
Prepainted panels for packing hall (OSD facility)
Manufacturing internationally acclaimed and certified products for the pharmaceutical industry, Fabtech Technologies International Pvt Ltd, has a diverse portfolio of products with an extensive market reach. Ayesha Augustine writes about the business model of the company, which has paved the way for future growth. abtech Technologies International Pvt Ltd (Fabtech) was started in Mumbai in 1999, to manufacture Laminar Airflow (LAF) benches, at a facility which was spread over an area of approximately 1,000 sq ft. Expanding its product offerings in a short span of two years, it started manufacturing cleanroom equipment in 2001, and gradually moved to manufacturing modulars in 2003. After gaining expertise in these solutions, the company ventured into manufacturing isolators in 2006 in the Indian market,
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which was considered to be a domain of the West, till then.
Being selective Challenges are a part and parcel of any new business. Likewise even Fabtech had its ups and downs. Not being bogged down by financial constraints, which was a major challenge among others that the company faced in the start up stage, Fabtech stepped beyond borders and expanded domestically too. Today, it has a facility spread over an area of about one lakh sq ft, equipped with state-of-the-art machines
IN FOCUS
from Europe and Japan. With the idea of manufacturing LAF for its overseas clients and projects, Fabtech steadily moved into the domestic market with modular pre-fabricated partitions. Informs Aasif Khan, Managing Director, Fabtech Technologies International Pvt Ltd, says, “We are among the pioneers to launch pre-fabricated partitions in India, a market dominated by European companies.” However, the company has retained its oldest turnkey division called ‘Fabtech Turnkey’, which specialises in turnkey pharmaceutical projects, design & construction of cleanrooms. Moving up the ladder the company then started manufacturing containment solutions, recognising the immense potential offered by this segment. According to Khan, few years down the line, they aim to become a specialist construction company with offerings present worldwide. He trusts that healthcare has immense growth potential irrespective of any setbacks, and hence shall remain the company’s focus.
The research mantra Research is an important facet of Fabtech Technologies, as Khan maintains. This is indicative from the fact that Fabtech has been developing brand extensions and new launches for a while now and will continue doing so in the years to come. As he informs, “We have few exciting products that we plan to unveil keeping in mind the trends in the market.” He believes that this will help the company keep pace with the growing requirements of clients. He recollects the transition from pre fabricated partitions to Restricted Access Barriers (RABs) to isolators now. “The best example is the evolution of our product portfolio from prefabricated partitions to isolators and RABs. These products were mostly manufactured and dominated by European manufacturers and now we have an expertise and an edge over the same. Besides, our projects are
Aasif Khan Managing Director
We continuously keep track of the innovations happening across the globe, and think beyond that, so as to develop better, cost-effective and high-end products in the market. Nonetheless, the idea of providing better solutions to our customers drives us to meet the challenges.
always manufactured in-house, except our marketing spearhead,” avers Khan. What gives them an edge, Khan says, “Our manufacturing facility is well equipped to manufacture products, both in quality and quantity, and that too at par with global standards.” What makes us a brand to reckon with, is the unique selling proposition of making difficult things sound simple, thus giving us an edge over other players in the market, says Khan. Fabtech has its in-house team of pharmacists, engineers and technicians who are exposed to well-known national and multinational pharmaceutical companies, thereby offering them formidable multilateral skills of pharma engineering.
The product basket Khan owes Fabtech’s reach and portfolio to its team for the consistent growth. The company offers prefabricated partitions, cleanroom equipment, injectable and oral lines, containment solutions, etc that are widely used in pharma and biotech facilities. Fabtech is one of the few international companies to have inhouse manufacturing of pre-fabricated panels, cleanroom equipment and injectable lines. As Khan underlines the reasons, “We have customised our offerings based on our client’s needs, as we believe that each market needs to be understood, and then treated accordingly.” He elucidates with the help of an example, “In the domestic arena, we work on panel and isolation system, and for our
international buyers we sometimes take up a complete turnkey project from concept to commissioning.” And hence the portfolio of its clients is from the Big Pharma to SMEs depending on their demands. Khan continues, we undertake pharmaceutical projects from concept to commissioning worldwide. Till now the company has undertaken repeated projects for more than 45 clients over 16 countries. As he explains, “The quality of our product speaks for itself, which is visible from our clientele in healthcare as well as other areas. We continuously keep track of the innovations happening across the globe, and think beyond, so as to develop better, cost-effective and high-end products in the market. Nonetheless, the idea of providing better solutions for our customers drives us to meet the challenges thrown by the demanding clients, and our international product certification makes us the desired choice.”
The ‘people’ factor Khan
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being
the
next
generation
SS panelling for powder filling Suite (powder injectable area)
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IN FOCUS
entrepreneur, and his ideology that workforce forms the crux of any business, is what counts him among the leading players in the pharma machinery industry. The company being one of the forerunners in the pharma industry in terms of cleanroom equipment, employs a multi-disciplinary, qualified and experienced team for pharmaceutical engineering, environmental control, electrical engineering, instrumentation, mechanical & process control. Besides, it also has a highly skilled team of in-house professionals to run its complete turnkey service from ‘concept to commissioning’. With 380 employees till date, they are keen on creating more employment as and when new technologies and products are launched.
‘Quality’ matters According to Khan, Fabtech is committed to providing total solutions in the area of pharmaceutical & biotechnology facility design and execution to cater to quality-conscious clients. All products are designed accurately at facilities that conform to the current norms specified by the international regulatory agencies like the US FDA, Medicines and Healthcare products Regulatory Agency (MHRA– UK and consequently EU), Therapeutic Goods Administration (TGA-Australia), etc. The company has also received approvals from Pharmadule-Sweden, which places it among American and European pharma equipment manufacturers. Khan feels that having offices worldwide provides them with the necessary international exposure and knowledge about the latest technical developments worldwide in this field. With products certified by Warrington Fire Laboratories (UK), the American Society for Testing Materials (ASTM) and the US, the company has a well-equipped facility that houses international machinery & technologies from Europe, Japan and Korea as well as state-of-the-art validation equipment
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from the US. All this underlines the quality and standards that the company maintains leaving no chance for errors and no options for clients, to choose, but, ‘just Fabtech’.
Designing the business plan Being highly competitive has kept Fabtech fast paced and helped market its products to other important markets. And this was acknowledged by Chemtech which honoured the company with an award for ‘The outstanding contribution to the engineering industry’ for manufacturing affordable panels for the Indian users. As Khan feels the next wave of products will emerge from biotechnology, therefore most of the projects undertaken by Fabtech now
With products certified by Warrington Fire Laboratories (UK), the ASTM, and the US, the company’s facility houses international machinery & technologies from Europe, Japan and Korea as well as state-of-the-art validation equipment from the US. are for the biotechnology sector, as it covers 63 per cent of its turnover. A repeat clientele ranging from the likes of Pfizer, Strides, Lupin, Astra Zeneca, Biological E to Ranbaxy has helped Fabtech to become one of the fastestgrowing companies for partitions and isolators in the country.
Global footprint The company believes customer satisfaction is the key to business. With
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this in mind it has set up its after-sales service centres throughout the country. The company’s four international locations in the Middle East and the UAE ensure smooth execution of projects. In the meanwhile Fabtech also operates in the US, European Union, China, Middle East, Africa, Afro Arab, East Europe, etc. Moreover, it plans to take its business to emerging countries like China or the regulated markets of Europe and further explore new markets in India. Besides, the company has also forged alliances in North America, Europe, Latin America and South Africa. Khan remarks, “Our strong presence across borders only signifies that collaborations give us an opportunity to grow faster and develop our product line to suit the needs of the clients. This strategy helps us lead the Indian market while supporting other markets.”
Prospects So far, the company has grown organically, without any foreign technical joint ventures, as Khan believes that this gave them enough space to move and sell freely without any hassles. Fabtech has recently formed a joint venture with an Australian company. As he believes that the technology acquired from the Australian company is appropriate for the Indian market, and would bring about a phenomenal growth and change over the conventional method used currently. Lately, the company has begun exporting high-end products to China from its Indian facility, and has also collaborated with Teco Srl, Italy, for laminate partition for the Middle East. Till now we manufactured only inner boxes. However, recently we have acquired a technology for manufacturing outer boxes as well, concludes Khan. This signifies that Fabtech is moving towards achieving its next target of becoming a specialist construction company.
INDUSTRY UPDATE
Implementation of proper IT and automated solutions aids the smooth functioning of various pharma manufacturing processes. And this has made India count and compete at a global level. KTP Radhika Jinoy provides an update on the latest developments in the IT and automation segment of the pharma industry.
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INDUSTRY UPDATE
he Indian pharmaceutical industry has undergone a metamorphosis in the early 90’s. Competition with global organisations demanded compliance with various regulatory requirements like the US Food and Drug Administration (USFDA) for increased production efficiency and reliable quality. High competition, less time to reach market and a highly regulated environment have forced Indian pharma companies to adopt advanced and latest Information Technology (IT) and automation solutions. “The critical factor for every company is to ensure continuous improved efficiency at every stage with faster Return On Investment (ROI). For accelerating the process of product research, development cycle & sales, strategic adoption of IT becomes necessary. Indian pharma companies have realised the importance of IT and have thus started implementing integrated IT and automation solutions in their manufacturing facilities,” says Pradeep Ramanujam, IT Manager, Anglo-French Drugs & Industries Ltd. Adding to this, K Sudhakar, Business Consultant, APAC Region, Informatics, Thermo Fisher Scientific, says, “With paper-based documentation and file-based manual information exchange among various departments, it was difficult for pharma companies to maintain the quality of production, while adhering to timelines as demanded by market forces. Adoption of the new IT and automation process has helped them to improve the efficiency and accuracy of the entire system. The advent of integrated systems like Enterprise Resource Planning (ERP) has reduced information silos in various departments.” Also adoption of IT and automation processes helps pharma
t
Pradeep Ramanujam IT Manager, Anglo-French Drugs & Industries Ltd
The critical factor for every company is to ensure continuous improved efficiency at every stage with faster ROI. For accelerating the process of product research, development cycle and sales, strategic adoption of IT becomes necessary.
companies to meet the complex requirements of managing bulk drugs and formulations business. The product streamlines procurement of raw materials and reduces procurement & delivery cycle times. It also helps to support unique business processes rapidly and cost-effectively by helping the functionality across finance, supply chain management, e-commerce, customer relationship management, human resource management, and knowledge management & business analytics. Johnny Ma, General Manager, Health and Life Sciences, Asia Pacific, Hitachi Data Systems, avers, “Nearly 30 per cent of the data stored on the world’s computers today are pharmaceutical details, and this figure continues to increase. Pharmaceutical institutions consistently need to upgrade their storage systems to accommodate their ever-increasing stream of drugs & chemical records.” Furthermore, this data should be easy to replicate and restore in
the event of a disaster. An understanding of the benefits of improved IT and automated solutions by pharma companies has increased their usage in the same. Ashit Panjwani, Executive Director, Marketing, Sales & Alliances, SAS Institute (India) Pvt Ltd, says, “Today, Indian companies are leveraging better on technology. Investment in IT and related infrastructure has increased across the entire value chain of a pharmaceutical organisation.”
Importance of IT and automation in pharma A pharma process typically comprises primary and secondary areas. Abhijit Tambat, Chemical and Pharma Sector Incharge, Siemens Ltd, informs, “Primary process is a complex batch process, wherein Active Pharmaceutical Ingredients (APIs) are produced through either biological or chemical process. Secondary process is a discrete,
K Sudhakar Business Consultant, APAC Region, Informatics, Thermo Fisher Scientific
Adoption of the new IT and automation process has helped to improve the efficiency and accuracy of the entire system. The advent of integrated systems like ERP has reduced information silos in various departments.
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INDUSTRY UPDATE
Johnny Ma General Manager, Health and Life Sciences, Asia Pacific, Hitachi Data Systems
Nearly 30 per cent of the data stored on the world’s computers today are pharmaceutical details, and this figure continues to increase. Pharmaceutical institutions consistently need to upgrade their storage systems to accommodate their ever-increasing stream of drugs & chemical records. machine-oriented production process in which APIs from the primary process are mixed with other inactive ingredients, formed and packed. The pharma manufacturing process also requires an aseptic environment and related controls (HVAC controls & building automation). Such a variety of processes demand that IT and automation suppliers equip themselves with a wide range of products and related process expertise for implementation.” Penetration of IT and automation in the Indian pharma industry can be broadly divided into computerisation and automation of process workflow, and IT applications for data management. Initially, automation in the process was limited to closed loop controllers and Programmable Logic Controllers (PLCs). Most plant machinery were semi-automated with a manual control over the automatic processes. Although these processes still remain highly reliable, initially, their standalone operations and proprietary communication protocols made it difficult to use them in an integrated environment. Some of them were not appropriate for the new guidelines of several regulatory agencies. Constructive feedback to the vendors and working closely with them enabled the launch of new lines of controllers that are seamlessly
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integrated to process management systems and ERP systems. With the advent of centralised control systems and Process Information Management Systems (PIMS), it is now possible to centrally manage these controllers. Purpose-built Laboratory Information Management System
The right choice of IT and automation solution for the manufacturing process will make a remarkable difference in achieving manufacturing excellence without compromising on quality. (LIMS) solutions, created specifically for each laboratory workflow, eliminate the need to customise a part of software to suit a laboratory workflow, which is time-consuming. “This centralisation provides multiple data in a manageable central location. This substantially reduces the time spent in taking corrective actions, recalibration, etc, and increases the operational efficiency. Nearly 70 per cent of the Small and Medium Enterprise (SME) pharma companies
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utilise automation in one form or the other in production, even though the penetration level of higher-end solutions like PIMS still remains to be upgraded,” explains Sudhakar. Informatics solutions that integrate proprietary software solutions became popular in the early 2000’s. The web-based architecture and web-enabled technologies brought the hitherto proprietary software solutions to a common communication platform. It is now possible to connect a business process software and ERP with a laboratory software solution. A number of organisations are now capable of providing the interface as required. Another major use of IT in drug development is for data analysis. “Large amount of data needs to be analysed during a clinical trial. Better integration of software will help in proper tabulation and analysis of data,” says Panjwani. Documentation is a key requirement for submission of data to regulatory agencies. It is essential to properly store many types of documentation in relevant folders with date & time stamp and proper approvals in place. The documents can range from scanned image of a molecular structure, to a detailed report of Quality Assurance (QA) and Quality Control (QC) on a batch sample as well as email correspondences. Document Management Systems (DMS) are the tools that capture these heterogeneous data and intelligently present them for appropriate documentation in a validated environment. For example, NextDocs is a tool based on Microsoft Share Point that can be used in modules like Standard Operating Procedures (SOPs) management, QA Management, etc, with seamless integration. Various software platforms can receive data from these DMS and present them in a format acceptable to regulatory agencies.
INDUSTRY UPDATE
Courtesy: AB Controls, Inc
Process Analytical Technology Ashit Panjwani (PAT): Production methods and Executive Director, Marketing, Sales & Alliances, SAS Institute (India) Pvt Ltd demands for a market share have created the need for rapid and Today, Indian companies are leveraging complete understanding of the manufacturing process. An increased better on technology. Investment in IT emphasis on manufacturing and related infrastructure has increased efficiency demands increased across the entire value chain of a real-time process information. To pharmaceutical organisation. support these industry needs, the USFDA has developed the PAT initiative. The PAT aims to understand and control the manufacturing data to transform information into more convenient. The wealth process to ensure the quality of knowledge can be done better by of information available on the drug by maintaining the quality using IT. The adoption of enhanced Internet has helped the pharma of manufacturing process rather IT processes has improved the industry, like every other industry, in than measuring the quality of quality of product and technology, terms of knowledge, resources, drug at the production stage. reduced the costs and provided references, etc,” says Ramanujam. IT “PAT can be implemented with the easy accessibility,” informs Ma. The has helped computerise business of appropriate processes, help of automation system using implementation thus streamlining appropriate analytical instruments IT helps prevent errors in drug businesses to make them extremely to monitor process quality parameters manufacturing as well as improves cost-effective and obtain enhanced and analysing these parameters in pharmaceutical production outcome. ROI. This, in turn, increases productivity, various layers of automation system Besides, several other advantages which ultimately gives rise to profits for appropriate quality. The prompt pharma companies to adopt and cost control. introduction of PAT has a new IT and automated solutions. considerable positive impact on As Partha Kundu, Executive Director, The flip side explains, Unlike petroleum and chemical reducing production costs. PAT is PricewaterhouseCoopers applicable for primary as well as “It provides a better insight production, which are continuous secondary manufacturing process. It on customers and better sales in process, pharma production also accelerates decision making on forecasting. Also, the new solutions is a batch process. Hence, the the unit operation level to improve provide streamlined procurement & informatics solutions configured quality and efficiency of the process, inventory management, improved for continuous processes cannot be leading to real-time decision making,” production planning, agile sales force, says Tambat. improved controls Enhanced outcome & and better insight productivity into business.” IT has Implementation of better IT & enabled businesses automated solutions has helped to be open 24x7 the pharma industry to improve globally. “A business decision making and enhance its can now be open outcomes, conveying the right anytime & anywhere. information to the right place at the This is due to right time. It also helps to bridge the availability the information gap between of e-commerce, research and clinical care by bringing e - p r o c u r e m e n t , together heterogeneous data e - s a m p l i n g silos. “Managing huge amount of and e-detailing information resulting from research methods, which Automated robotic titration (Tix), used for R&D and production studies, medical records and image has made things
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INDUSTRY UPDATE
Abhijit Tambat Chemical and Pharma Sector Incharge, Siemens Ltd
Primary process is a complex batch process wherein APIs are produced either through a biological or a chemical process. Secondary process is a discrete, machine-oriented production process in which APIs from the primary process are mixed with other inactive ingredients, formed and packed. easily customised for the pharma industry. “Therefore, solutions need to be created for this industry or configured specifically. Hence, the overheads are high with configuration or customisation of a dedicated solution. Adding to this is the validation requirements that drive the prices still higher. The cost barrier is a major deterrent with long deployment time before the company actually begins to benefit from such deployments,” informs Sudhakar. Technological bases are changing rapidly and unpredictably, and so are the customer’s preferences and needs. Every company is unique and has different requirements. Hence, one successful method or implementation might not help in another company’s unique requirement. “Implementation rarely happens without any difficulties and we need to be ready for a tryand-succeed method. Implementing new technology and application means that there will be changes in the way business is done. For this both the management and employees of the company need to adjust to such changes,” says Ramanujam. Technology cannot immediately increase efficiency. In reality, there is a learning curve that people need to face, which involves a host of challenges. In the SME segment, the cost of maintaining a dedicated IT team is a
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challenge. A dedicated team is needed for the maintenance of hardware & software, updating them periodically for version change, bug-fixing and having a proper disaster recovery protocol. They prefer to outsource these non-core activities and focus on their core competency of drug manufacturing. However, security is a key issue in the outsourcing of such an activity. “Besides, awareness of new IT technologies and solutions is a challenge that the SME sector faces. Further, business processes that are not standardised, high cost of ownership for IT, lack of internal skills for effective use of IT to drive business benefits, etc, increase the roadblocks to the SME players,” says Kundu. New business models centered around cloud computing, where IT infrastructure and application software are available as a service, would help address some of these issues. Also, there is a need for a holistic approach, to deploying proper IT solutions across the organisation. This initiative should come from the management to reduce the use of relevant IT tools consistently and effectively.
Going future perfect According to experts, with cloud computing taking centrestage, the future of IT and automation seems promising. Commonly called as Software-As-Service (SAS), a
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well-planned cloud computing environment ensures that one can safely outsource the IT requirement or maintain it with minimal investment without fear of loss of data, downtime in production due to IT breakdown or in the event of a disaster. With the Pay-per-Use approach, IT solutions have now become affordable for the SME segment as well. Industry standard ERP systems are also using the SAS approach for deployment. The demand has increased for technology-enabled business transformation, constant innovation in technology and technologyintensive products & services across all segments within the pharmaceutical industry. Meanwhile, experts predict an increased trend for off-shoring as well as outsourcing in the coming years. Social computing (powered by web 2.0 technologies) as well as creation of new technologies to form & extend networks will shape the future IT products, services, projects and skills. Also, green IT and environmental computing will be pursued due to increased environmental concerns. With regard to the automation solutions front, most pharma manufacturers are moving towards increasing the use of automation technology for manufacturing processes. A majority of automation solution providers are creating new solutions, which can help in seamless integration of the entire manufacturing activity, both vertically and horizontally. As these technologies enter the workforce, they will transform the way in which businesses operate in the Indian pharma industry. However, selecting the right solutions appropriate for one’s industrial needs is important. The right choice of both IT and automation solution for the manufacturing process will make a remarkable difference in achieving manufacturing excellence.
MARKET TRENDS
OTC marketing & branding
Reshaping the strategies The government plans to create a formal list of pharmaceutical products that can be sold Over-The-Counter (OTC.) A diligent and carefully designed marketing & branding strategy is important, and will go a long way in marketing and building a brand. Chandreyee Bhaumik discusses the different approaches that can be adopted to develop a successful brand, and the future trends likely to gain momentum in this space.
ver the years, India has seen a gradual but steady shift from prescription to Over-The-Counter (OTC) drugs. The present Indian OTC healthcare segment is still at its infancy. As per various reports, currently India ranks 11th in the global OTC market and is expected to move up the ladder to the 9th position within five years. Further, the Indian OTC market accounts for approximately $ 1,793 million and is predicted to be growing at an annual rate of 23 per cent.
o
Current Indian OTC landscape With rampant technological progress, increasing health awareness and high work
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stress levels, urban India is gradually adapting and adopting the concept of OTC healthcare. Considering the changing outlook of the masses and both expected & unexpected amendments in regulatory framework, such as OTC guidelines, open distribution etc, the Indian OTC market is likely to make a significant contribution in the near future. Also, there seems to be a similarity between India and China with regard to the fact that there is a shift from the doctor-driven markets to pharmacy- or chemist-driven market. In China, the regulatory amendments executed in the last four to five years have helped the OTC market flourish. These changes have enabled several global players to invest in
MARKET TRENDS
their local company’s OTC divisions in order to build OTC brands. At present, cough, cold, aches, hyperacidity, indigestion, contraception and minor topical infections are some of the popular OTC categories while the other emerging areas include wounds, cuts, muscle pains & sprains, constipation and diarrhoea. Opines Dr Ajit Dangi, President & CEO, Danssen Consulting “In India, there is no formal OTC policy or any schedule in the Drugs & Cosmetics Act. Thus, drugs that do not fall under the schedules H, G and X, by default come under the OTC (non-prescription) category. Further, as the Indian healthcare market gradually moves from illness to wellness, several categories like vitamins & minerals, iron/calcium salts, antacids, cough & cold medicines, digestives, dermatological creams, pain balms, etc, render considerable opportunities as these remedies are well suited for OTC promotion.”
Importance of marketing and branding Considering this growth momentum, many pharma companies now attribute more importance to the marketing and branding strategies of these products. Avers Dr Anuuj Saxena, Managing Director, Elder Health Care Ltd, “Strong marketing and branding practices have established top OTC brands in India such as Vicks VapoRub, Amrutanjan Balm, Zandu Balm, Iodex, Moov Pain Relief Cream, Itch Guard Cream, ENO Fruit Salt, Vicks Cough Drops, Halls Lozenges, etc. Therefore, it is very important to have a very strong brand building, which is targeted at achieving the maximum coverage, reaching maximum consumers and most importantly registering a very strong top of the mind recall.” Seconding the thought, Hitesh Gajaria, Executive Director, KPMG says, “In case of OTC products, it is the consumer and not the physician
Dr Ajit Dangi President & CEO, Danssen Consulting
The Indian consumer is very discerning and is always looking for value for money and therefore developing a strong value proposition through intensive market research is necessary before plunging into OTC territory. (as in the case of prescription drugs), who decides on which product and brand to purchase. Hence, it is important to establish the image of a product in the eyes of the customer, who may not be aware of the therapeutic properties of the pharma product.” Considering that a number of brands exist for the same drug molecule in the market, the strategy for marketing and branding of these products needs to be well-planned and formulated. Opines Gajaria, “It is important to build an emotional bonding and a relationship of trust and comfort with the customer to ensure loyalty and hence consistent sales. There is a need to differentiate a product from competition and establish a positive image of the drug and the company in the eyes of the customer. Hence, effective marketing to place the product in the eyes of the customers and strong branding to ensure high brand recall are critical to ensure effective sales. For example, the brand image of Crocin as a pain killer and an antipyretic is so strong in the market that paracetamol (generic name) has almost lost significance to the common person.”
Evolution of marketing & branding strategies Over the past few years, marketing and branding strategies have evolved manifold. Many changes have been incorporated by companies with respect to the manner in which
drugs ere marketed earlier. Suggests Dr Saxena, “Earlier brands (which are now OTC) were promoted using the classical pharma route wherein the product used to be promoted to the medical fraternity (viz Otrivin, Volini Digene, Bendryl etc). With the advent of huge expansion of media, especially the electronic media, the focus of these brands has shifted to directly reach the consumer segment. As a result, heavy investments are being done in television, radio, print space.” Today, many OTC medicine categories like multivitamins, antacids, analgesics, health supplements, cough liquids etc are advertised by the television mode. Further, many companies have started considering pharmaceutical marketing strategies as an important medium in their drug promotional strategy. According to Gajaria, companies which have embraced a scientific sales-driven approach are now employing marketing and branding strategies to a much greater extent and in his opinion, these changes can be attributed to the increasing general health awareness in the consumers, increasing competition or just smarter, and more demanding patients/customers. Further, the concept of emotional marketing seems to be catching up pace in recent times, with companies going that extra mile by making efforts to appeal to the emotional side of the consumer. Elaborates Gajaria, “Branding today is not only about
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MARKET TRENDS
Dr Anuuj Saxena Managing Director, Elder Health Care Ltd
Electronic media will continue to be the major medium for most companies, to reach the consumer directly. Also, rural marketing will gain momentum to help companies increase their sales.
placing the product favourably in the eyes of the customer but also about creating a strong emotional impact. Companies are now aiming to strike an emotional chord with the customer rather than merely educating him about the product. Emotional marketing therefore has emerged over informational marketing today.”
Designing an innovative approach v For marketing: In today’s highly competitive scenario, a robust marketing approach is important for a company manufacturing OTC drugs. This approach/ strategy has to be designed diligently and carefully, taking into account the different related factors. As Dr Dangi avers, “The Indian consumer is very discerning and is always looking for value for money and therefore developing a strong value proposition through intensive market research is necessary before plunging into OTC territory. As more and more malls, supermarkets and convenience stores begin to emerge, consumer habits are also changing and many a times purchases are made on impulse. In such cases, a brand with attractive packaging, which can stand out from the clutter on the shelf and is supported by a strong advertising campaign, is likely to win/ emerge victorious.” Further, the approach should be formulated keeping in mind that the consumer is ignorant or does not possess much therapeutic knowledge
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about the product and its sideeffects. In Gajaria’s opinion, since OTC products are typically purchased without medical advice, there is a need for raising awareness regarding the information required to appropriately diagnose and manage the therapeutic indication followed by the rational use of the drug and inform the consumer about the possible abuses of self-medication. Also, these strategies have to be devised keeping in mind an ignorant target that may not be aware of the therapeutic worth or possible sideeffects of the drug. Additionally, the marketing strategy for different systems of medicine would vary depending on the special characteristics and attributes of the respective products. Opines Gajaria, “In the Indian market, homeopathy and ayurveda medicines are widely used and are generally considered to be safer than allopathic drugs due to the use of herbal ingredients. Therefore, each practice (ayurveda, homoeopathy and allopathy) would have different marketing strategies, focussing on its unique advantages. For instance: allopathic treatment may focus on quick relief; whereas ayurveda and herbal products may emphasise on the use of natural products and project on long-term stamina building.” v For branding: Besides, as there are plethora of drugs available in the market, factors that influence brand building and development are vital. As Gauri Chaudhari,
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Independent Consultant, OTC and Ethical Pharma Brands, suggests, “There is a lot of ‘feeling’ associated with diseases or ailments by the patient-consumer, in a way that he either feels unwell or fine. These feelings are extremely crucial to understand and to translate in communications and branding hallmarks. Here, mnemonics or visual identities help to perform this function quite efficiently. For example: Vapours in Vaporub or movement depicted by Moov on its packaging cover can be considered as important brand hallmarks.” She also adds that communication is important in OTC advertising and plays an important role by depicting the way in which the medicine works inside the body.” Besides these, the brand image and reputation of the company also go a long way in carving a niche for the product in the market. Suggests Gajaria, “Successful OTC branding constitutes many factors such as product quality and efficacy, brand image of the company marketing initiatives by the company to increase awareness about the formulation.”
Marketing a brand Effective marketing strategies need to be developed for promoting and distributing all pharma productsbranded, generic and OTC products. Highlights Dr Saxena, “One of the key tasks is to identify opportunities in different markets and distribution channels, and pursue those to develope and establish new relationships in the marketplace. Managed care and Internet marketing are areas that need to be considered to create growth opportunities for brands. New product developments, packaging innovations, economic/ lifestyle influences, distribution or pricing issues and forecasts that illustrate how the market is set to transform should be the must followed and adopted strategies.
MARKET TRENDS
Of late, many new methods have been introduced that have metamorphosed the manner in which drugs were marketed earlier. Opines Gajaria, “The marketing strategies adopted nowadays in case of OTC drugs mainly involve mass media promotion to the people. Smart television commercials that elicit emotion and a celebrity/famous role model narrating stories about the product that evoke an emotional response in the viewer help to draw consumer attention and establish the product image in his/her mind. Next, featuring the company at a trade show or convention can also be an effective way of gaining face–to-face attention. Additionally, marketing by way of advertorials can also help as these are advertisements with editorial content helping to educate the public about the products. Further, placing written information in strategic locations like pharmacy stores, clinics and publishing
Hitesh Gajaria Executive Director, KPMG
In case of OTC products, it is the consumer and not the physician who decides on which product and brand to purchase. Hence, it is important to establish the image of a product in the eyes of the customer, who may not be aware of the therapeutic properties of the pharma product. magazines with the information can be another way of attracting the consumer’s attention.”
Role of technology Various technological advances have divulged an all together new dimension for reaching out and communicating the essentials to a wider population base. Similar is the case with marketing & branding of OTC drugs. Elaborates Dr Saxena, “Every company will extend their
efforts in order to reach and cater to maximum number of consumers. In this endeavour, they will adopt various mediums of technology like the Internet, television, radio, satellite TV, DTH services, etc.” Also, today, many companies are considering promotion via web as an effective way to connect to a target audience. According to Chaudhari, taking into account the media cost and clutter, breaking conventional rules of reaching out to people has become extremely crucial
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MARKET TRENDS
Gauri Chaudhari Independent Consultant, OTC & Ethical Pharma Brands
Taking into account the media cost and clutter, breaking conventional rules of reaching out to people has become extremely crucial and the digital world has provided this opportunity.
and the digital world has provided this opportunity.
Reaching out to the rural base In the urban set up, the customer base is usually well informed, educated and brand conscious; therefore, it has more exposure to media and modern facilities. Comments Gajaria, “Lack of formal education, technology, wellestablished distribution, infrastructure and basic amenities are the major issues affecting the rural population. Thus, corporate branding is not as important in rural areas as it is in urban regions. For targeting the rural population, the company will have to focus on creating a strong brand recall and differentiation for its products. Hence marketing strategies in these areas would focus on convincing the customer that their needs are known and acknowledged; educating the customer about the product, the etiology of the condition, the symptoms and the management steps; and finally making the product available to them easily, by using proper distribution channels. For this the company will have to take responsibility of educating the rural customer about the use of the products and its benefits, rather than merely focussing on the branding aspect.” On the other hand, Dr Saxena has a different opinion where he feels that the marketing and brand building strategy in the rural as well as urban areas should broadly be the same as the communication to
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the consumer has to be consistent. In his opinion, the success of a brand in both these regions willbe determined by the distribution reach.
Constraints and ways to overcome Although the different marketing and branding approaches have improved and refined with time, there are still many challenges that need
It is important to build an emotional bonding and a relationship of trust & comfort with the customer to ensure loyalty and hence consistent sales. to be effectively countered for the OTC market to experience consistent growth. On the regulatory scenario, there is no formal policy for OTC drugs or any schedule in the Drugs and Cosmetic Act. Suggests Dr Dangi, “OTC medicines play an important role in healthcare in a resource starved country like India where the doctor to population ratio of 0.6 doctor per 1000 is one of the lowest in the world. Responsible self-medication reduces the burden on medical professionals and can help him/her (medical professional) render more attention
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on the critical areas. The government therefore needs to design a formal OTC policy and introduce changes in the Drugs Act.” Besides these, other bottleneck areas include intensifying competition, customer’s inadequate knowledge about the therapeutic effects of the product, complex distribution channels etc. For overcoming these restraints, Gajaria states, “An efficacious product that is cost-effective, packaged well and branded attractively would be able to hold out against competition while the marketing strategy that focusses on highlighting the therapeutic worth of the drug and thereby educating the customer would be more effective in terms of ensuring sales. Last, considering that the Indian market is fragmented with a complex distribution network of 60,000 distributors and around 700,000 – 800,000 retailers, a marketing strategy that encompasses a high level of penetration and accessibility will be desired.”
Future trends With the OTC market ready to explore the growth different marketing and branding trends are likely to evolve in the future. Avers Dr Saxena, “Electronic media will continue to be the major medium for most companies, to reach the consumer directly. Also, rural marketing will gain momentum to help companies increase their sales.” As many pharma companies are predicted to enter the OTC space in the future, an innovative and robust marketing & branding strategy will be the one that will distinguish the winners from the survivors. On the same thoughts, Dr Dangi concludes, “At the end of the day, no matter how smart one’s marketing strategy is but to succeed in OTC business, one requires patience, deep pockets and long term commitment, as ROI in OTC is most likely to be a long drawn affair.”
MARKETING
The next level of pharma marketing
Keeping the patient at the forefront The ‘healthcare triad’ consists of physician, drug manufacturers and at the apex of these two lies the patient. However, the manufacturers of drug and medical equipment have the sole aim of selling their products with the aid of doctors. But it should be noted that in the absence of the ailing patient, the ‘healthcare triad’ remains incomplete as it is the patient who forms the raison
d’etre of the other two elements of the triad. competition among drug firms has led to the current situation where the physician is coaxed so as to generate the desired volume of business. A lot of heat and dust has been raised by the government on the issues revolving around ethics in medical practice when doctors accept gifts from pharmaceutical companies. This controversy has led to the Medical Council of India (MCI) adopting a new amendment to the Indian Medical Council (IMC) Act for regulating such methods of sales promotion, earlier this year. However, a good way to initiate a change in this scenario would be to place the patient, instead of the doctor, at the focal point of the pharma marketing procedure. This could be a more effective way of generating business through doctors.
Shift the focus Courtesy: ChiroMatrix™ - Discover Wellness™
Dr Rajan T D edical representatives or managers often complain on how difficult it is to make some doctors prescribe their drugs. Alternatively, they can lead a discussion on some newer tactic adopted by them to persuade physicians on choosing their company products. Presently, every promotional method adopted by the pharmaceutical companies revolves around winning over the physician to promote their products. Increasing
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Now, the guidelines have tightened the screws of the pharma sector, which has been guilty of unethical promotion of the drugs. Therefore, at present the industry needs to move away from this physician-centric approach and develop newer strategies to generate growth. With the increasing global population as well as lifespan, there is bound to be a rise in health related problems in the future. Besides, people are also taking precautionary measures to prevent major illnesses. A nagging cough, whitish patch on the cheek, little heaviness in the head or transient spell of dizziness make the patient search the Internet or consult the
MARKETING
Healthcare triad The ‘healthcare triad’ consists of physician, drug manufacturers and at the apex of these two lies the patient. When a satisfied patient happily leaves the doctor’s cabin quickly, the latter can move on with his work at a rapid pace. In order to make this process of treating and healing more efficient, pharmaceutical companies should adopt marketing practices that are patient-centric and make a doctor’s job easier, rather than trying to convince the latter by other means. doctor at the earliest. Today, even the slightest hint of any deviation from the norm makes a patient visit a doctor to rule out any underlying illness. Keeping these facts in mind, there is no doubt that the expenditure by patients and the government on healthcare is expected to grow manifold. The drug marketers and manufacturers, who select high quality products, will undoubtedly do well even in the face of tough competition. Yet, they should continue to innovate and find newer methods of getting closer to their patients, those that will serve as a backdoor entry into the hearts of physicians.
Help the healer Marketing managers need to well-understand that a physician performs several tasks in the course of his work. He is not only a prescriber of drugs or an advisor on diet and lifestyle, but he is also a counsellor, guide and sympathiser. A doctor, therefore, spends a lot of time doing things other than writing clinical notes. He listens to his patients, comforts them and helps them take decisions regarding the choice of crucial surgeries or starting drugs that could have major side-effects. Many a times, there are some queries pertaining to basic medical facts that well-read patients are
usually aware of, but this may not be known to others who are illiterate or who are highly qualified yet do not have a scientific bent of mind. To solve such queries, a committed doctor usually draws diagrams and charts inorder to explain the pathology of the disease, mode of surgery, etc. But this is again very time consuming. Besides, this overworked physician is also expected to be at the patient’s beck and call. He may also be expected to answer something mundane, which could interrupt his initial train of thought. Several senior physicians confide that they would have to deal with fewer queries and phone calls from patients, if the latter were better informed. Therefore, the pharmaceutical companies can help the patients in increasing their level of knowledge about diseases and drugs which will, hopefully, save the doctor from being flooded with sundry questions.
What disturbs doctors? Barring those in major cities and towns, average Indian patients are not highly educated. Further, their information on health and diseases is distorted by half-baked knowledge of traditional healing systems and grandma’s recipes. When these patients go to a physician, the queries they pose to a doctor can be clubbed under the following categories: Details of their disease Modalities of medical and surgical treatment available Existence of alternative, dietary or lifestyle approaches Methods to prevent diseases or its aggravation Methods to alleviate suffering, in the case of chronic/major life-threatening diseases Availability of government-aided medical schemes and health centres that provide cheaper treatment
Information on social and financial support provided by government agencies and private institutions Rehabilitation centres Inspite of a physician being well placed to deal with all these issues, it is not humanely possible for him to be omnipresent around the disturbed family. A social worker or a trained medical volunteer would be ideal in tackling most of these queries. However, very few hospitals in the emerging economies have a band of such volunteers, and thus, to address these concerns is ultimately considered as the doctor’s responsibilty.
Pharma counsellor Thus, the drug manufacturers can help in relieving the burden on the physicians by providing basic information on health and disease prevention to the patients. There is an urgent need for informative and well-illustrated brochures and leaflets about the success of therapies in common illnesses like tuberculosis, leprosy, arthritis, cataract and night blindness. Most companies have been supplying patient information
Tutoring the patient v Patient education leaflet on specific diseases, which should be multilingual and in simple language explained with lot of illustrations and examples v Plastic models of organs and internal components that can be assembled and detached for explanation v LCD screens displaying medical information as slide shows v Touch-screen kiosks kept in waiting rooms of clinics for patient education and information v Drug related information provided to patients on cell phones as SMS v Regular mailers and email updates on chronic diseases to the patients who desire v Helpdesk or toll-free telephone information services
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MARKETING
brochures and hand-outs to answer some disease related patient queries. However, most of these brochures are designed to promote the drugs manufactured by the company rather than health of the patient. Therefore, marketing managers should look at this from a purely service-oriented approach, wherein they should prepare information booklets on topics related to general health besides plainly promoting their products. However, it is an irony that these leaflets are usually printed only in English, while most English-educated readers have access to the Internet as well as to the existing print and electronic media. Besides, large sections of the patient population do not understand English. Therefore, for reaching out to all corners of the society, these brochures should also be printed in the locally spoken vernaculars. Diagrammatic charts and flyers that a doctor can display at his clinic are already being made by many pharmaceutical manufacturers. However, the organ models with internal parts that can be detached or assembled while talking to a patient are also very useful in educating patients. Today, with the use of modern technology, several innovative methods can be devised that will be helpful to both the doctor and patient.
The drug marketers and manufacturers, who select high quality products, will undoubtedly do well even in the face of tough competition. Yet, they should continue to innovate and find newer methods of getting closer to their patients, those that will serve as a backdoor entry into the hearts of physicians. Self-help groups Those patients suffering from major illnesses like cancer and paralysis take a long time to recover from the shock of the disease. Likewise, patients suffering from non-fatal but ‘social’ disorders like leucoderma and leprosy also face a certain amount of turmoil. Such patients would require a great deal of emotional support in order to accept the diagnosis and move on with the treatment. This could weigh down on the physician, who might already be battling a hectic schedule. For such patients, pharmaceutical companies can facilitate the development of self-help groups. Physicians can direct
Diseases requiring emotional support Major illnesses: Leukemias, cancers, stroke Chronic diseases: Rheumatoid arthritis, SLE, renal failure, complicated diabetes Developmental disorders: Autism, cerebral palsy Disabling diseases: Parkinsonism, poliomyelitis, neurovascular disorders leading to amputation and paralysis, motor neuron disease, osteogenesis imperfecta Sensory disorders: Optic nerve or retinal diseases leading to blindness, hearing disorders or deafness Skin disorders: Leucoderma, neurofibromatosis, pemphigus, psoriasis, Reiter’s disease, scleroderma, disfiguring types of epidermolysis bullosa or porphyria
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chronic patients and their family members to these groups to solve their day to day problems. Further, Self-Help Groups (SHG) assist in motivating and encouraging patients and their families to never give-up and to persist with the treatment in order to prevent the progression of the disease. In such groups, patients and their families can glean valuable information from others who have recovered from similar conditions. Pharmaceutical companies can also invite noted experts to address these patients or their family members, who will then get a forum to meet and interact with their peers. A brief list of disorders where SHG would be useful is listed in table below.
Strengthening the bond Initially, these solutions may appear as complex processes. The entire exercise may also seem to be very demanding when compared to the ease of the traditional marketing methods. However, if one needs to score over the nearest competitor, this is an angle worth pursuing. Many existing firms have adopted this approach in a piecemeal manner. Yet, a sustained effort by the pharmaceutical sector to educate patients will go a long way in securing a solid healthcare triad. Dr Rajan TD (MD, DVD, DNB) is an alumnus of Mumbai University and practises as a Specialist in Skin & STD in Mumbai since 1991. He regularly writes in various periodicals on several social issues as well as those relating to the pharmaceutical industry. He has been the Associate Editor of ‘My Doctor’. He advises pharmaceutical industries on drug development, promotion and marketing strategies. Dr Rajan is an Honorary Consultant to ONGC, Indian Airlines, Air India and Larsen & Toubro Ltd. He also teaches at CMPH Medical College, Mumbai. Email: rajan.td@gmail.com
INDUSTRY OUTLOOK
Blood disorders therapeutics market
A promising pipeline With more patent expiries giving way to biosimilars and opening up the market for generics, top five companies having a controlling stake in the blood disorders market will change soon. The article gives an insight into the current scenario and a few projections. n 2009, the global blood disorders market was estimated to be worth $ 38.4 billion, representing a Compounded Annual Growth Rate (CAGR) of 7.7 per cent between 2001 and 2009. By 2016, the same is expected to reach $ 50.8 billion, indicating a CAGR of 4.1 per cent between 2009 and 2016. The decline in the growth rate is due to the decrease in the annual cost of treating blood disorders after 2011.
i
Top five companies controlling the market The current global blood disorders market is significantly consolidated, as the top five players in the market control approximately 77 per cent of the market. Currently, Amgen is the market leader with four blockbuster products, namely, Neulasta, Aranesp, Epogen and Neupogen, controlling 28 per cent of the total blood disorders market. Sanofi-Aventis follows with a 22 per cent marketshare, primarily due to its top-selling anticoagulant Plavix, co-marketed with Bristol-Myers Squibb (BMS), and its venous thrombosis drug Lovenox. BMS comes third and is attributed to the sales of Plavix, besides which, it does not have any significant presence in the branded blood disorders market. Ortho Biotech and Baxter are the fourth and fifth largest players, primarily due to Procrit, indicated for anaemia and Advate, indicated for haemophilia, respectively. The two companies control seven and five per cent of the total market for blood disorders therapeutics, respectively. However, marketshares of top players are expected to change in future as two of the top companies in the current market, Amgen and Ortho Biotech, have registered negative
Marketshare of top manufacturers in global blood disorders market, 2008 Ortho Biotech Products 7%
Major licensing agreements by Phase, 2009–2010
Baxter 5%
Filed 8% Others 23%
Phase III 8%
BMS 15%
Sanofi-Aventis 22%
Approved 15%
Pre-Clinical/ Discovery 31% Amgen 28%
Phase II 38%
Source: GBI Research
growth in recent years. On the other hand, other top three companies, Sanofi-Aventis, BMS and Baxter, have shown a positive growth, greater than the overall market growth. With M&A activity in the blood disorders market at a very low level, the future dominant players are expected to be those who come up with novel, safer, more efficacious and more convenient therapeutics in the blood disorders market.
Optimistic R&D future The licensing landscape in the global blood disorders market has remained dry in absolute terms. During 2009 and the first two months of 2010, only 13 major licensing deals were signed. However, the positive aspect of these deals is that 69 per cent of them involve early stage discovery molecules, which include the discovery, preclinical and Phase II stages. While 38 per cent of the deals were signed for molecules in Phase II, 31 per cent of the deals took place for the molecules in the preclinical and discovery Phase. Approximately
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INDUSTRY OUTLOOK
eight per cent of the deals were signed for molecules in Phase III development. The approved drugs contributed to approximately 15 per cent of the total licensing deals for the blood disorders market while eight per cent of the deals happened for drugs currently waiting for market approval. The large majority of deals involved in the early stage development drugs, suggests that market players are showing strong interest in strengthening the future pipeline potential of the industry. With a series of patent expiries expected to hit the blood disorders market, the need for novel drug candidates to successfully complete the clinical development stages and reach the market is strong.
Patent expiries The global blood disorders market is expected to witness a series of patent expiries between 2009 and 2016, which includes most of the top-selling blockbuster drugs in the market for anaemia, thrombosis, haemophilia and neutropenia. The major drugs set to lose patent protection are as follows: NovoSeven (2010), Plavix (2011), Lovenox (2012), Neupogen (2013), Epogen (2013), Procrit (2013), Kogenate (2014), Aranesp (2014) and Neulasta (2015). Together, all these drugs account for more than $ 24 billion of revenue in the global market for blood disorder therapeutics.
With M&A activity in the blood disorders market at a very low level, the future dominant players are expected to be those who come up with novel, safer, more efficacious and more convenient therapeutics in the blood disorders market.
In the pipeline The current blood disorders product pipeline contains 299 products across four indications. Anaemia and thrombosis currently accounts for more than two-thirds of the total blood disorders market and are the key therapy areas of focus in the development of the current pipeline products. Also, almost 73 per cent of the total projects for anaemia and thrombosis are in early stage research, which suggests that the future anaemia and thrombosis market can expect some novel drugs. The haemophilia and neutropenia markets are comparatively smaller than those of anaemia and thrombosis. With less market opportunity available, pharmaceutical companies do not consider these indications as their top priorities. Drugs for these two indications are largely developed by niche companies and then out-licensed to big players. Haemophilia drugs occupy 18 per cent of the pipeline, with 53 projects divided between haemophilia A and haemophilia B diseases. On the other hand, neutropenia accounts for close to one-tenth of the blood disorders product pipeline, which is mainly dominated by projects on granulocyte colony stimulating factors.
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Though the current blood disorders drgus’ pipeline offers some promising novel products, the revenues generated from these products are not expected to completely offset the revenue losses due to the impending patent expiries.
Market drivers The factors which are expected to drive growth in this market are: 1. Steady rise in incidences of anaemia: An increase in iron deficiency and the higher prevalence of cancer diseases has resulted in the
July 2010
growth of anaemia cases at the rate of 3.2 per cent per annum between 2001 and 2009. Growth has been significant among the top five countries in Europe, particularly the UK. The top five countries added approximately 6.8 million anaemia patients between 2001 and 2009, of which 2.6 million were from the UK. The rising prevalence of blood disorders has had a cascading effect on the overall prescription population, resulting in increased prescriptions dispensed for blood disorder products. 2. Rapid uptake of biologics: This mainly happened due to better efficacy and safety of these drugs in diseases such as anaemia, haemophilia and neutropenia. Between 2001 and 2009, a number of biologic drugs entered the market, including Aranesp (2002) for anaemia, Advate (2003) for haemophilia and Neulasta (2002) for neutropenia. All of these drugs became major blockbusters and registered revenues of approximately $ 6.8 billion in 2008 with an exponential growth rate due to their better efficacy and safety as compared to the other medications available at that time. In addition, several other drugs were also launched in the late 1990s, including BeneFIX in 1997, NovoSeven in 1999 and Refacto in 2000 for haemophilia. These drugs also became successful in their disease indications, accounting for revenues of close to $ 1.8 billion as of 2008. Between 2001 and 2009, a number of new biologics entered the market, which resulted in significant market growth as physicians started prescribing these safer, more efficacious and convenient medications to the patients. 3. Patent expiries of expensive biologics: The global blood disorders market has witnessed a significant growth in the prescription population due to patent expiries of expensive biologics drugs. In the future, the growth of the prescription population is expected to increase as a series of patent expiries in this market will make way for the entry of biosimilars.
INDUSTRY OUTLOOK
The average annual cost of therapy for anaemia, haemophilia and neutropenia increased at a CAGR of 4.7 per cent between 2001 and 2009. The growth rate will be reduced to 0.8 per cent between 2009 and 2016, as the cost of major biologics will reduce by about 20-30 per cent. However, with the high-cost biologics, the reduction will result in a considerable increase in the prescription population.
Market constraints Inspite of these positive effects, there are some factors which continue to impede the progress in this market and need to be addressed. 1. Low diagnosis rates: A low diagnosis rate is one of the main characteristics of the increase in blood disorders, as the contemporary diagnostic tool can only diagnose moderate forms of diseases and fail to detect the more severe forms. In 2009, only 17.1 per cent of the population suffering from anaemia was diagnosed positively. With anaemia accounting for the largest disease population of all the blood disorders, the low diagnosis rate in anaemia reduces the overall diagnosis rate within this market. However, in future, with better diagnostic tools expected to hit this market, the diagnosis rate may increase to a certain extent. Diseases such as haemophilia and neutropenia have a higher diagnosis rate (more than 80 per cent), but the overall small patient population nullifies its effect on the total diagnosis population for the blood disorders market. 2. Sluggish growth in the annual cost of therapy: Between 2001 and 2009, the annual cost of therapy in the global blood disorders market grew at a rate of 4.1 per cent per annum. However, the entry of biosimilars into the blood disorders market in future is expected to reduce the market growth due to reductions in annual cost of therapy. In addition, the patent expiries of two of the largest selling blood disorders products, Plavix and Lovenox, will also open up the market for generics.
Predictions While the current pipeline in the blood disorders market does offer some promising products, the novel products are not expected to completely recover the revenue lost due to patent expiries. With the rapid entry of generics into the market, the cost of treating blood disorders is expected to grow at a very low rate. The annual cost of therapy in the global blood disorders market is expected to grow at a nominal rate of 0.2 per cent per annum between 2009 and 2016. However, the growth will not be uniform throughout the period as the annual cost of therapy will reach its peak in 2011 and decline gradually until 2016. Courtesy: GBI Research
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INDUSTRY INSIGHTS
Pancreatic cancer drugs market
Need for more and better drugs With only one drug, Gemzar from Eli Lilly in the market, which loses patent protection in 2010, there is a pressing need for more drugs to treat this debilitating disease. The article underlines the reasons for the drought in the pipeline in this segment. Opportunity and unmet need in the pancreatic cancer market, 2010 Efficacy High
High
Low Unmet Need = 71% X $787m = $558.7m
Low
Safety
Unmet need is high (71%) for pancreatic cancer
Next steps - Unmet need likely to remain the same over the next few years.
Gemcitabine Gemcitabin+Xeloda
Gemcitabine+Tarceva Tarceva
Note: Size of the bubbles represents the approximate cost effectiveness of the product/combination
better than many other chemotherapeutics. It is approved for a plethora of oncology indications, like pancreatic cancer, non-small cell lung cancer, metastatic breast cancer, recurrent ovarian cancer and bladder cancer (only in the European Union). Gemzar is reported to account for about 60-65 per cent of the pancreatic cancer drugs market in the US and Europe. Further, Eli Lilly is in discussion for the development of an oral Gemzar pro-drug with the potential for unique intellectual property protection, which, according to reports in 2010, was in Phase I trial. The patent for Gemzar in the US will expire by the end of 2010, but the generic versions of Gemzar have already been launched in some of the Northern European countries. This is expected to lead to depletion of market revenues, between 2009 and 2013. However, the market is expected to stabilise by 2016.
High unmet need ancreatic cancer is one of the most challenging forms of cancer to treat but the market for pancreatic cancer drugs has fewer competitors as over other cancer drugs’ market. This is due to the high incidence of failure in late-stage clinical trials. In 2005, Supergen withdrew a filing for Orathecin, due to insufficient data to gain approval for the drug. Further, Aphton announced that its drug Insegia failed to meet its primary endpoint in Phase III trial. GenVac also announced the failure of TNFerade in 2010. Since there is an immediate need for treatment, the Food & Drug Administration (FDA) has deemed fast track designations for drugs and therapeutics used in pancreatic cancer management.
p
Generic erosion of Gemzar Owing to its wide usage and strong physician acceptance, the drug Gemzar from Eli Lilly will remain the drug of choice for treating pancreatic cancer. The side-effects of this drug are also
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Limited treatment options and lack of safe and efficacious products have led to an increase in the unmet need for pancreatic cancer treatments. This scenario will remain unchanged in the future as well, if there are no new molecules that could significantly influence this need. Among the various cancers types, pancreatic cancer has the highest mortality rate. The median survival time for metastatic pancreatic cancer is only three-six months. In such cases, highly efficacious drugs are difficult to develop, accompanied with struggle to gain regulatory approvals since authorities have set up stringent protocols and expect a statistically significant improvement in overall survival, before finally approving a new drug. This is done to avoid a serious adverse event that could possibly lead to the untimely death of a patient but it indirectly discourages newer drugs from entering the market. Thus the unmet need is expected to remain high. Courtesy: GlobalData
EVENTS CALENDAR
National
Pune
Ahmedabad
Indore
Maharashtra
Gujarat
Madhya Pradesh
Chennai Tamil Nadu
Nov 19-22, 2010
Dec 17-20, 2010
Feb 18-21, 2011
Mar 04-06, 2011
India’s premier industrial trade fair on products and technologies from machine tools, fluid power, instrumentation & control, electrical & electronics, material handling, plastics, rubber, packaging, chemical, CAD/CAM, auto components, and general engineering.
For details contact:
Engineering Expo Infomedia 18 Limited, Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4649, Fax: 022-3003 4499 Email: shamal@infomedia18.in, Website: www.engg-expo.com
Novel Drug Delivery Systems A two-day conference on technical strategies that will leverage upon the latest advances in ingredients, materials, devices and safety & efficacy testing to drive innovation through NDDS developments; August 19-20, 2010; at The Westin Mumbai Garden City, Mumbai For details contact: UBM India Pvt Ltd, Mumbai Tel: +91-22-6612 2600 Fax: +91-22-6769 2462 Email: jennifer.tsao@ubm.com Website: http://www.ndds-india.com
SCM Pharma India 2010 A conference on specific supply chain management issues affecting Indian pharmaceutical companies; August 26-27, 2010; at The Westin Mumbai Garden City, Mumbai For details contact: UBM India Pvt Ltd, Mumbai Tel: +91-22-6612 2600 Fax: +91-22-6769 2462 Email: jennifer.tsao@ubm.com We b s i t e : h t t p : / / w w w. s c m p h a r m a india.com/
PROMACH 2010 An exhibition featuring cutting-edge technologies and process plant & machinery for an array of industries
including the pharmaceutical industry; October 01-04, 2010; at Bangalore International Exhibition Centre, Bengaluru For details contact: Bangalore International Exhibition Services Pvt Ltd, Bengaluru Tel: +91-80-6583 3234 Email: dayanand@bies.co.in Website: http://www.promach.co.in/
For details contact: CMP India (UBM India Pvt Ltd), Mumbai Tel: +91 22 66122600 Fax: +91 22 66122626 Email: deepalim@ubmindia.com Website: www.pmec-india.com
2nd India Lab Expo 2010
Biosimilars India 2010 The 2nd Annual Biosimilars India 2010 conference, a two-day strategic event that will provide an opportunity to assess the market, determine the right technical strategy and drive the development and registration of biosimilars products both in India and overseas; September 30-October 01, 2010; at Le Royal MĂŠridien, Mumbai
A scientific and laboratory instruments exhibition in India, this expo will have more than 250 exhibitors from different countries showcasing their innovative products; December 10-12, 2010; at Pragati Maidan, New Delhi For details contact: Scientificdealers.com Tel: +91-11-2760 4500 ; Fax: +91-11-2760 4600 Email: info@indialabexpo.com Website: www.indialabexpo.com
Plastivision India 2011 For details contact: UBM India Pvt Ltd, Mumbai Tel: +91-22-6612 2600 Fax: +91-22-6769 2462 Email: jennifer.tsao@ubm.com http://www.biosimilars-india.com
An exhibition organised by AIPMA, Plastivision India 2011 is the 8th in series, and this event will highlight the key developments & growth of the plastics industry; January 20-24, 2011; at NSE Complex, Mumbai
P-MEC India 2010 An exhibition showcasing state-of-theart pharma machinery and equipment for pharmaceutical operations; December 01-03, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai
For details contact: AIPMA, Mumbai Tel: +91-22-67778899; Fax:+91-22-28252295 Email: marketing@plastivision.org Website: www.plastivision.org
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EVENTS CALENDAR
International Drug Discovery Technology – USA The four conferences taking place at IBC’s Drug Discovery & Development Week will highlight the unprecedented explosion of new research and applications being announced almost daily in the fields of cancer genomics, cancer drug development, antibody therapeutics and next-generation sequencing applications in drug/diagnostic development; August 02-04, 2010; at San Francisco, CA For details contact: IBC USA Conferences Inc, Westborough Tel: +1 (508) 616-5550 Fax: +1 (508) 616-5522 Email: custserv@ibcusa.com Website: www.drugdisc.com
Analytica China 2010 A conference devoted to laboratory technology, analysis/quality control, biotechnology and life sciences, which brings together decisionmakers from leading biotechnology, pharmaceutical and investment companies. The event will assemble a large number of visitors and exhibitors related to laboratorytechnology sector from all over the world; September 15-17, 2010; at Shanghai, China For details contact: Messe München, Germany Tel: +49 (89) 9 49-2 07 20 Fax: +49 (89) 9 49-2 07 29 Email: info@messe-muenchen.de Website: http://www.analyticachina.com
SIPEC 2010 A pharmaceutical trade show that provides a good opportunity to network and generate new clients, while gaining an insight into the developments in
the industry; September 28-30, 2010; at Parc des expositions d’Orléans, France For details contact: Sipec, France Tel: +33 (0)2 38 95 30 49 Fax: +33 (0)2 38 95 24 29 Email: infos@sipec.net Website: www.sipec.net
BIOTECHNICA 2010 An event for the biotechnology and lifesciences industry. It covers various elements in the field of biotechnology, including f u n d a m e n t a l s, equipment and bioinformatics & services. An opportunity for associated people to find new customers and partners for their products & services, and to network with various professionals from the industry; October 05-07, 2010; at Deutsche Messe Hannover, Germany For details contact: Deutsche Messe AG Hannover, Germany Tel: +49 (0)511 89 0 Fax: +49 (0)511 89 32626 Email: info@messe.de Website: www.messe.de
Expopharm 2010 An exhibition highlighting the current trends and developments in the pharmaceutical sector. More than 500 exhibitors from diverse fields catering to the pharma industry are expected to be present at the event. The event presents an ideal opportunity to network with different visitors and generate new contacts; October 07-10, 2010; at Munich, Germany
For details contact: WUV (Werbe- und Vertriebsgesellschaft Deutscher Apotheker mbH), Germany Tel: +49 (0)6196 - 928 412 Fax: +49 (0)6196 - 928 404 Email: besucher@expopharm.de Website: www.expopharm.de
FoodPharmaTech 2010 An international trade fair for machinery, packaging and ingredients of the pharma as well as food industries. This year’s event will focus on four areas: efficient production, product safety, energy & environment and knowledge sharing. Professionals from the pharmaceutical, biotechnology and cosmetic sectors are expected to be present at the event; November 02-04, 2010; at Exhibition Centre Herning, Denmark For details contact: Messecenter Herning, Denmark Tel: +45 99 26 99 26 Fax: +45 99 26 99 00 Email: mch@mch.dk Website: www.foodpharmatech.dk
Bio-Europe 2010 Considered to be one of Europe’s largest partnering conferences, the event attracts biotechnology and pharmaceuticals professionals. It provides an ideal opportunity to identify and enter into strategic relationship with companies of interest; November 15-17, 2010; at International Congress Centre, Munich (ICM) For details contact: Bio (Biotechnology Industry Organization) Tel: +1 (202) 962 9200 Fax: +1 (202) 488 6301 Email: cbeckman@bio.org Website: www.ebdgroup.com
The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals
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BOOK SHELF
Mouse models for drug discovery: Methods and protocols Editors Price
: Gabriele Proetzel and Michael V Wiles : Rs 5,486.95
Considering the shift in the drug discovery process towards specific target pathways and models, this book details the use of mice as experimental model platforms in general research as well as those specific to diseases like cardiovascular disease, cancer, type I & II diabetes, skin disorders, arthritis, anxiety & depression, neuromuscular, neurodegenerative and infectious diseases. The presence of large numbers of mouse models makes it difficult to cover the entire arena of mouse applications in the drug discovery process. Divided into 23 chapters, the book highlights the general background and some specific diseases with an idea of acquainting those less familiar with mice as experimental model platforms. One chapter is dedicated to the general features of experimental design, coping and managing the risks of working with live animals & other aspects, while another emphasises the pharmaceutical approach of using genetically engineered mouse models for target identification and its validation. Additionally, another chapter illustrates the power of combining new imaging tools with genetically engineered mice for the purpose of drug discovery. Further, some chapters focus on the possibility of engraftment of human tissue into mouse, like in regenerative biology and stem cell research. The book will update scientists and researchers in academics and their respective industries on the latest trends and help them in considering the approaches in drug discovery. It will also be beneficial to students in comprehending their field of work.
Focussing on the development and enhancement of pharmaceutical manufacturing equipment and their uses, the book provides technical solutions to assist in catering to the needs of finished products for the pharmaceutical manufacturers. It also highlights practical trainings, based on current techniques and approaches. The book highlights the methods to train people for developing, manufacturing, auditing and validating biopharmaceutical products. The book not only describes rules and protocols but also imparts knowledge on the ready-to-use formulae for developing Master Plans, Standard Operating Procedures (SOPs) and various validation protocols. Classified into several chapters, the book encompasses various cleaning procedures for the commonly used equipment in various manufacturing areas and their sampling points. Thus, the book will benefit readers to update the cleaning validation matrix approach and modify the protocols as and when required. This book will be important to people involved in the biopharmaceuticals and pharmaceutical manufacturing industries. It will help training managers, cleaning task executors, trainees, entry-level technicians, production managers, quality assurance managers, quality system auditors, consultants, supervisors, research & development formulators, etc.
Cleaning validation manual: A comprehensive guide for the pharmaceutical and biotechnology industries Editors : Syed Imtiaz Haider and Erfan Syed Asif Price : Rs 6,452.50
Mehul Book Sales, Shop No 1, Lokagutchh Jain Upashraya Building, W H Marg, Fort, Mumbai 400 001 For purchase inquiries, please contact, Tel: 022-2265 4657 / 2269 4145, Fax: 022-2265 4657
July 2010
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FRESH ARRIVALS
Thermo Fisher Scientific launches new checkweigher and metal detector Thermo Fisher Scientific Inc, recently announced two new high-performance offerings for the pharmaceutical industry, i.e., Thermo Scientific APEX 500 Rx metal detector and Thermo Scientific Versa Rx checkweigher. The APEX 500 Rx system is based on the APEX metal detector platform, delivering very good sensitivity, total stability and automatic performance verification via the patented AuditCheck feature. “The APEX 500 Rx meets a major need in today’s market, a cost-effective
metal detector that provides the highest level of product safety required for the pharmaceutical industry,” said Bob Ries, Product Manager, Thermo Fisher Scientific. Further, equipped with a unique slack belt system, the Versa Rx can handle weighing, control and reject functions at line speeds up to 500 packages per minute. “There is more than 50 years of experience and expertise behind the Versa Rx, which helps set its performance, accuracy and durability apart from checkweighers in its
New optical pH sensing cuvettes for non-intrusive pH monitoring Smart pH cuvettes, proprietary sol gel coating materials developed by Ocean Optics, enable convenient and nonintrusive pH monitoring of biological samples. By encapsulating pH indicator dyes, Ocean Optics miniature fibre optic spectrometers and accessories can now be used for optical pH sensing of 5.0-9.0 pH range samples. The smart pH cuvette’s immobilised indicator dye is encapsulated in a robust sol gel matrix, allowing diffusion of ions while preventing leaching of the dye. This system provides full spectral analysis to help eliminate errors from changes in turbidity, temperature and ionic strength. The physical properties of the immobilised indicator dye eliminate the need for frequent calibration. Smart pH cuvettes measure one-cm square and are available in Plastic Polymethyl Methacrylate (PMMA) or quartz. Their inner walls are coated with a sol gel embedded with bromocresol green pH indicator dye. The PMMA cuvettes have a temperature range of -5 °C to 70 °C and quartz cuvettes are used in high-temperature applications. The PMMA cuvettes are compatible with aqueous solutions, ethanol/methanol solutions, ammonia, peroxides and sodium hypochlorite solutions, while quartz cuvettes can be used in acetone and concentrated acids. PMMA cuvettes are disposable, but they can be used multiple times depending on sample environments.
class,” said Volkert Jan Hage, Product Manager, Thermo Fisher Scientific. Both systems are available with full pharmaceutical v a l i d a t i o n Vera Rx-APEX Rx documentation. They combination have been designed in keeping with Good Manufacturing Practice (GMP) principles and are supported by the extensive worldwide network of Thermo Fisher Scientific services.
ACG North America introduces AF-200(T) for automatic capsule filling ACG North America has introduced AF200(T), the latest in its AF series of capsule filling machines. The AF-200(T) offers one of the fastest ACG AF-200(T) automatic capsule filler encapsulation speeds, filling up to 200,000 capsules per hour. It is equipped with ACG’s new, patented Zero Relative Motion (ZRM) technology that minimises segregation during operation, thus reducing waste and fugitive dust. The AF-200(T) can fill a large variety of powder formulations, pellets, micro tablets and combination fillings into hard capsules. It has an output of 200,000 capsules per hour for powder and 170,000 capsules per hour for pellets. The AF-200(T) features an easy-to-use touch screen and allows machine speed adjustment from the main panel. The precise slug dosing principle enables high filling accuracy, making it cost-effective and increasing the yield.
XPert® TXE equipment enclosures provide safe, ventilated containment for powder-generating apparatus
XPert® TXE equipment enclosures
XPert® TXE equipment enclosures from Labconco Corporation are designed to address the needs of pharmaceutical research and quality control laboratories. It has an interior height of 42” and accommodates equipment like pill presses, grinders, crushers and sieves. This equipment provides a safe, ventilated space for keeping powdergenerating apparatus.
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The TXE features a patented zone-perforated rear baffle that creates horizontal laminar airflow to maximise containment. This vented equipment enclosure may be ducted to the outside or connected to the FilterMate™ portable exhauster for High Efficiency Particulate Arrestor (HEPA) or carbon-filtered exhaust back into the laboratory. Other features of this equipment enclosure include a static dissipative epoxy-coated metal exterior, stainless steel interior sides & integral work surface, two adjustable height glass doors and a fluorescent lamp.
FRESH ARRIVALS
Purifier® Cell Logic® biosafety cabinets to accommodate microscope for cell research Labconco Corporation’s new Purifier® Cell Logic® biosafety cabinets meet the specific needs of delicate cell research while sharing the same exclusive Electronically Commutated Motor (ECM) technology features of the Purifier® Logic®. The Purifier Cell Logic biosafety cabinets from Labconco feature the Scope-Ready™ package allows the user’s microscope to be integrated into the cabinet. Two additional features, Pure-Vu™ seal and StandPurifier® Cell Logic® Still™ isolation platform, work accordingly to ensure biosafety cabinets containment and reduced vibration. Further, the TempZone™ area on the cabinet work surface allows heated or chilled samples to remain at optimum temperature. The cabinet is available with either Scope-Ready™ or Temp-Zone™ options or both.
Sparta Systems unveils Version 8 of TrackWise® software
Sparta Systems, Inc, maker of TrackWise® software and the market leader in enterprise quality & compliance management solutions - recently announced Version 8 of its TrackWise® Enterprise Quality Management Solution (EQMS). The TrackWise® 8 features the highest level of configurability of any EQMS and provides new capabilities to enable rapid, parallel deployment of business processes in enterprise environments and increase usability for the infrequent user. The TrackWise® software now includes a revised form layout with new workflow visualisation functionality that graphically displays the position of users in the
workflow, how they reached there and the subsequent steps. The added flexibility in the TrackWise® software will allow companies to perform a wide variety of maintenance activities independent of new project development. This furthers companies’ ability to continue to adopt existing processes to meet changing business requirements and regulations while independently continuing the rapid build-out of new business processes. Mike Jovanis, Vice President, Product Management, Sparta Systems, said, “The new enterpriseclass capabilities in TrackWise® 8 take an already powerful migration platform and add a greater level of agility and concurrency to system expansion and maintenance, while our workflow visualisation is aimed towards helping infrequent users work in a self-guided fashion.”
Waters’ ACQUITY UPLC H-class method development system for better automation
Waters Corporation recently unveiled its new Waters® ACQUITY UPLC® H-class method development system that automates liquid chromatography method development according to Quality-by-Design (QbD) guidelines to produce robust, fit-forpurpose methods in remarkably less time than conventional processes. The superior performance of the new system stems from the power and integration of four class-leading components: ACQUITY UPLC® H-class, Fusion Method Development™ software, Empower™ 2 chromatography data software and Waters® method development chemistry Kits. The ACQUITY UPLC® H-class method development system uses the QbD-based methodology for LC method development, allowing scientists to establish the best possible method at a higher speed. “The ACQUITY UPLC® H-class method development system combines industryleading separation capabilities with cutting-edge, automated software and data management to consistently produce robust Liquid Chromatographic (LC) methods in a short time. This integration has taken the automated method development to an entirely new level of efficiency and productivity,” said Warren Potts, Pharmaceutical Business Director, Waters Corporation. The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of
Modern Pharmaceuticals
Share Information on your New Machinery & Materials The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing information on your newly developed technologies that are applied in pharma and allied sectors. Manufacturers, developers and sellers of pharma-related products, machinery, materials and software are invited to furnish details for publication in this section of Modern Pharmaceuticals. R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification. Write to us: Modern Pharmaceuticals Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 Fax: 022-3003 4499 Email: spedit@infomedia18.in
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PRODUCT UPDATE
Analyser
Strip seals
TTL Technologies offers ‘DIPA 2000’ particle size and shape analyser from Donner Technologies. It combines two complementary measurement techniques by integrating laser and video channels. It provides complete sample information on particle size distribution and numerous particle shape parameters with the help of very high analytical resolution (analysing each sampled particle individually) and real-time sample visualisation. The analyser has a wide measurement range of 0.1-5,000 microns. It comes bundled with the software for comprehensive data analysis and report generation. The instruments can be fitted with a variety of modular measurement cells, which can be manually interchanged to allow for particle analysis in liquids, emulsions, creams, dry powders, fibres, heated liquids, aerosols and more, with minimal (or no) sample intervention and original state analysis. Analytical data can be displayed in a wide variety of tables and graphs.
Novoflex Marketing offers pilfer proof strip seals, which prevent imitation of branded & quality products and help control adulteration & pilferage, thus protecting a company’s reputation and brand image. These have a tamper evident locking action in a one-piece construction and are precision moulded from durable, tough, highstrength, weather-resistant engineering Nylon 66 material. These strip seals are light in weight, corrosion effective, economical and cost-effective. The company’s name/logo can be permanently hot stamped on it. These seals can be used in the pharmaceuticals industries, bulk drugs, airlines baggages, postal department, chemical industries, bank lockers, courier bags, containers, drums, etc.
TTL Technologies Pvt Ltd - Bengaluru - Karnataka Tel: 080-2525 1859, Fax: 080-2529 1285 Email: analyticaldirect@ttlindia.com
Bar code reader Banner Engineering India offers iVu bar code reader (BCR), which reads 11 industrystandard bar codes to facilitate advanced traceability in packaging, material handling, automotive, pharmaceuticals and many industrial applications. The BCR with an integrated or remote touchscreen and intuitive interface allows users to configure, monitor, modify and inspect without a PC or external controller. It has following features: first-time users can also learn to use it without training; compact; rugged IP67-rated housing available with or without an integrated ring light; and RS-232 serial communication port is provided for exporting bar code data. The sensor is available with a remote touchscreen for setup and inspection monitoring. The BCR is available with three different trigger modes to determine how the sensor captures and processes images. Banner Engineering India Pvt Ltd - Pune - Maharashtra Tel: 020-6640 5624 Fax: 020-6640 5623 Mob: 9322339208 Email: salesindia@bannerengineering.com
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Novoflex Marketing Pvt Ltd - Kolkata - West Bengal Tel: 099031 63634, Fax: 033-2229 7814 Email: sales@novoflex.co.in
Centrifuges United Engineering Enterprises offers full-lid opening centrifuges, which conform to GMP standards for active pharmaceutical ingredients, herbal extracts, flavours, colours, chemicals and allied process industries. These centrifuges are of four-point suspension type in stainless steel construction. The entire body can be lifted & opened hydraulically. Thus, the basket and drain platform are exposed facilitating easy & quick cleaning. The body is hydraulically lowered into the closed position and clamped to the lower portion of the casing by means of quick clamps. These centrifuges are suitable for manufacturing facilities that require frequent product changeover. These centrifuges are available in various designs depending on cake characteristics and customer requirements, viz, standard top discharge, top discharge with bag lifting arrangement & bottom discharge with/without scrapper. The centrifuges can be offered in vapour tight construction with nitrogen blanketing for hazardous chemicals. The CIP design with built-in cleaning nozzles ensures no product cross-contamination. These centrifuges are manufactured in batch capacities in the range of 5-600 kg. United Engineering Enterprises - Mumbai - Maharashtra Tel: 022-2308 3990 Email: uenggent@gmail.com
PRODUCT UPDATE
Dryer Bombay Pharma Equipments offers fluid bed dryer and tray dryer. The fluid bed dryer is a process equipment used for uniform and efficient drying of products. It is available with or without PLC-based control, with capacities in the range of 5-500 kg. The fluid bed dryer is provided with stainless steel interconnecting duct lines with flanges for connecting remote mounted heating and fan motor modules. It is equipped with lifting and tilting device for easy handling, bag shakers, intrinsically safe earthing arrangement and bucket-type bottom chamber above ground level. The tray dryer is available with 6, 12, 24, 48, 96 and 192 trays with double wall construction. Made of SS frame work, with glasswool insulation, this unit comes with an air inlet, air filter and adjustable damper (outlet). It is also equipped with single insulated & self-locking door, and one fan for air circulation inside the area. The sophisticated control panel is with on/off push buttons and indicating lights. Bombay Pharma Equipments Pvt Ltd - Mumbai Maharashtra Tel: 022-2859 4877, 2852 1608, Fax: 022-2852 1608 Mob: 098201 24804, 98201 20086 Email: bombaypharma@vsnl.net
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PRODUCT UPDATE
Table top coder Process Instrumentation & Controls offers table top coder. This batch coding machine is suitable for all manual & automatic coding on various types of packaging. This easy-to-operate coder is compact in design, which makes it easy to install, where space is limited. It operates on a microprocessor-based system and is equipped with motorised intermittent reciprocal contact coder. The coder is used by manufacturers/packers of packaged goods to print batch number, date of manufacturing, expiry date, prices and other statutory information on various packaging, containers, labels, cartons, pouches, etc. It gives larger printing area upto 50 mm and can easily print 4-6 lines on various packaged goods. Process Instrumentation & Controls - Vadodara - Gujarat Tel: 0265-235 7228, 232 0756, Fax: 0265-235 5429 Email: batchprinting@yahoo.com
Bottle washing machine Laxmi Industries offers ‘model HLBW150’ high-speed linear bottle washing machine. This machine is totally fabricated from SS materials, including the basic frame. It is provided with highpressure spray nozzles, which ensure perfect wash of vials. It does not require any changeover parts for washing of bottles, thus saving time (on changeover). All parts coming in contact with washing zones/jet are made from SS-316 materials. The machine is suitable for washing of round and flat glass bottle. It is totally rigid and withstands continuous operation for long working hours without any trouble. Water re-cycling arrangement is provided as per customer’s requirement. Laxmi Industries - Ahmedabad - Gujarat Tel: 079-2289 3810 Email: laxmiindustries_ad@yahoo.com
Leak test apparatus Jicon Machines offers leak test apparatus. It is ideal for checking sealing integrity of blister, strip & pouch packs, capped bottles, etc. The leak test apparatus is extremely compact in construction and has low noise level. It is provided with polycarbonate vacuum dessicator, which sustains vacuum for long durations. The apparatus is made of stainless steel (GMP). It is equipped with built-in vacuum gauge and isolation valve and is provided with 0-5 minute timer for auto-stop. The leak test apparatus has a vacuum level of 550 mm Hg. Jicon Machines Pvt Ltd - Mumbai - Maharashtra Tel: 022-2851 0398, Fax: 022-2851 6488 Email: jicon.ind@vsnl.com
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PRODUCT UPDATE
Vibratory finishing systems Niraj Optical Machinery offers vibratory finishing systems, which incorporate a rubber or polyurethane lined bowl of ‘U’ cross section mounted on accurately calculated springs. These systems are driven by a highly efficient vibratory motor. The open top of the bowl can be loaded with suitable ceramic/plastic or steel media and parts to be processed. Vibratory finishers shake parts and media at high speeds, causing the media to scrub the surface of the parts in an action similar to lapping. Since the parts and the media are moving at small increments on each stroke, the parts are not subject to severe stress or damage. Vibratory finishers produce very smooth surfaces, are safe for delicate or heavy (metallic/non-metallic) parts, and have very good action inside recesses and holes. Vibratory finishing is preferred for general deburring, finishing, pre-plate finish, etc of delicate or heavy parts and for precision deburring/finishing. Vibratory finishing is also safer for threaded parts. Niraj Optical Machinery - Ahmedabad - Gujarat Tel: 079-2929 5747, Fax: 079-2583 3659 Mob: 9825554860, 9909904148 Email: badrakia@rediffmail.com
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PRODUCT UPDATE
Vacuum pump inlet/exhaust trap Avni Enterprises offers compact vacuum pump inlet or exhaust trap manufactured by MV Products of North Billerica, Massachusetts. This vacuum pump inlet protects liquid ring-, oil sealed-, and dry vacuum pumps from volatiles, organic solvents and acids in distillation, drying, degassing and similar processes. It combines several trapping methods into a single compact unit to condense, absorb and neutralise process byproducts from applications that generate volatiles, organic solvents and acids. It features three or four stages of effluent trapping, the first stage is a 200 sq inch baffle shield, which is surrounded by 3/8” ID cooling coils for condensing volatile solvents and chemicals on this large cooled surface. The third and fourth filtration stages are customised with activated alumina or charcoal, ‘Sodasorb®’ and other types of filter elements to remove residual solvent vapour acids and particulates. Constructed from stainless steel, these inlet traps are equipped with an optional bottom cooling section with a ¼” NPT drain plug. Avni Enterprises - Mumbai - Maharashtra Tel: 022-3296 8812, 3260 9641, Fax: 022-2405 6329 Email: avnient@vsnl.com
Chill roll flaker unit Steer Engineering offers chill roll flaker unit. It has a pair of adjustable roller, which is cooled and squeezes the molten material into a thin continuous band. The cooled extrudate is then passed through flaker, thereby reducing the material to small-sized chips suitable for feeding into the fine grinding machine. The squeeze roller in the unit is made using quality raw material and can be easily cleaned. It is made of heavyduty robust mild steel sturdy structure, with stainless steel squeeze roller. Its features include easy cleaning process, consistent speed, etc. Steer Engineering Pvt Ltd - Bengaluru - Karnataka Tel: 080-2372 3310, Fax: 080-2372 3307 Email: info@steerworld.com
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PRODUCT UPDATE
Blender Vyanktesh Fabricraft offers cone blender and ‘V’ blender, which are used for dry powder and granules homogeneously in pharmaceutical, food, chemical and cosmetic industries. All contact parts of cone blender are made of stainless steel of required grade. The company also offers customised cone blender. Twothirds of the volume of the cone blender are filled to ensure proper mixing. The ‘V’ blender is used for homogeneous mixing and lubrication of dry powders. The blender gives best result when approximately two-thirds of the volume are filled, at suitable medium speed and ‘V’ shape of the container. In ‘V’ blender, the powder comes from all sides due to the ‘V’ shape of the product container; hence, requirement of RPM is medium. Vyanktesh Fabricraft Pvt Ltd - Nashik - Maharashtra Tel: 0253-660 2691, 238 3603, Fax: 0253-660 2691 Email: vyankteshen@yahoo.co.in
CIP/SIP modules Industrial Equipwash, Inc, offers clean-in-place (CIP)/steamin-place (SIP) modules. The CIP/SIP technology offers significant advantages to manufacturing facilities from efficient cleaning of process equipment & piping at lower costs to improved product quality. CIP systems are fully integrated incorporating tanks, pumps, valves, spray cleaning devices, heat exchangers, piping and controls without the need to disassemble all or part of the system. This system significantly reduces cleaning costs and minimises handling of chemicals to provide a safer environment for plant personnel. The CIP process involves a sequence of cycles that includes an initial & final drain step and a pre- & post-rinse step. The CIP process may include a sanitising cycle to reduce the levels of bacterial contaminants. This cycle uses aqueous solutions of strong oxidants, eg hydrogen peroxide-, ozone- and chlorine-containing compounds. The controls incorporated into CIP systems are critically important and provide a variety of cycle times, temperatures and composition of cleaning solutions. Fully automated programmable logic controller (PLC)-based CIP systems are offered to suit customer specifications. Industrial Equipwash Inc - Mumbai - Maharashtra Tel: 022-2679 7941, Fax: 022-2679 2936 Mob: 098692 31815 Email: iewi@vsnl.net
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PRODUCT UPDATE
Rotary bottle washing machine Konark Machine Tools offers rotary bottle washing machine with geneva mechanism. This machine has four inner, one outer and one air wash. Easy operation, loading and unloading with two rows are the key features of this machine. The stationary nozzles eliminate contamination of water cycles. It is provided with individual solenoid valve for each washing sequence, which eliminates the use of carbon plate and other accessories, thus reducing leakages and maintenance to the minimum. Higher capacity centrifugal pumps are provided to wash bigger bottles (500 & 1,000 mL). The stationary nozzles avoid chipping of bottle necks. The pumps and tanks are mounted on portable stand for easy maintenance. The machine has an output of 60-100 bottles per minute. Konark Machine Tools - Ahmedabad - Gujarat Tel: 079-2760 2068, 2760 2212, Mob: 093749 90776 Email: info@konarklabelling.com
Turbine blower/exhausters Acmevac Sales offers turbine blower/exhausters, available in the range 0.5-15 hp. These are regenerative blowers and can be used for vacuum or pressure applications. The impeller is directly mounted on the motor shaft. There are no rubbing parts, and hence these blowers are practically maintenance-free and absolutely oil-free. Noise levels decrease, as these are provided with silencers. These blowers are particularly useful in areas where oil-less, continuous non-pulsating air flow is required. These find applications in air tables, agitation/aeration, vacuum hold down and pick up, air blow off, aquaculture, pneumatic conveying, etc. Acmevac Sales Pvt Ltd - Mumbai - Maharashtra Tel: 022-2837 5837, Fax: 022-2836 4977 Mob: 09223388105 Email: acmevac@vsnl.com
The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of
Modern Pharmaceuticals 74 Modern Pharmaceuticals
July 2010
Proximity sensors
Agitated thin film evaporator
Flavour enhancer
Pumps
Air handling units
Food & non-food packed products
Rapid endotoxin detection system
Air shower controllers
Forced circulation evaporator
Retro automation
Air showers
GMP heat exchangers
RFID
Air tents for operation theatre
GMP reactors
Rising film evaporator
Analyser
Heart valve frames
Rotary bottle washing machine
Analytical instruments
HPLC
Rotary multihead screw capping unit
Annular centrifugal extractor
HVAC clean room
Rotary tablet press
Automatic cream filling machine
Hydrogenator/autoclaves
Rotary vacuum dryers
Automatic overwrapping machine
Industrial control & sensing devices
Rotocone dryers
Automatic twin head powder filling
Infomedia18 B2B magazines
Safety light curtains
Informatics
Scraped surface crystalliser
Bar code reader
Information technology solution
Short path distillation unit
Blender
Injectable powder filling machines
Silicone carbide heat exchangers
Blow-fill seal machines
Skid mounted systems
Bottle washing machine
Interfacing with MIS packages
Sludge dryer
Capping machines
Invertor/variable frequency drives
Spherical paddle chopper dryers
Centrifuges
Lab equipments
Sticker (self-adhesive) labelling
Chill roll flaker unit
Laminar flow work stations
CIP/SIP modules
Leak test apparatus
Strip seats
Clean room equipments
Level controllers
Sweetness enhancer
Clean room projects
Liquid filling lines
Switching relays
Clean room validations & services
Liquid filling machines
Table top coder
Coding and marking labelling
Liquid-liquid extractor
Tablet bottle packing lines
Low RH air handling unit
Tablet press machine
Collating & overwrapping machine
Machine automation
Temperature controllers
Columns & chemistries
Masking agent
Three parameter display unit
Conical screw dryers
Measuring & monitoring relay
Timers
Contamination controller
Monoammonium glycyrrhizinate
Turbine blowers/exhausters
Counters & power supplies
Motion controllers
Turnkey projects
Dehumidifiers
Multiple effect evaporator
Twin-screw co-rotating extruders
Digital panel meter
Twin-screw elements
Door interlock systems
Packaging solutions for FMCG
Twin-screw extruders
Drives
Paperless recorder
Ultrasonic flowmeter
Dry syrup powder filling lines
Pass box interlock systems
UPLC
Dryer
Photoelectric sensors
Vacuum pump inlet/exhaust trap
Electrical (both HT & LT)
Plant automation solutions
Ventilator
Empower
Plant-wise SCADA solutions
Vibratory finishing systems
Vision inspection system
machine
Fax: +91-22-3003 4499 E-mail: b2b@infomedia18.in
Fire alarm
First Fold Here Inspection systems
machines
Tel: +91-22-3003 4684 / 4640
machine
Second Fold machines Here Packaging
Encoders
PLC/SCADA/DCS systems
ERP/SAP/LIMS/DMS clinical
Process controllers
Vision sensors
Process heat exchangers
Washing and air jet cleaning
Exhibition - Healthex 2010
Process reactors
Factory automation
Programmable logic controllers
Falling film evaporator
Programmable terminals
database systems
machines
Wet glue labelling machine
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Bangalore International Exhibition
Modern Pharmaceuticals
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PRODUCT INDEX
Product
Pg No
Product
Pg No
Product
Pg No
Access controller ........................................................21
Flavour enhancer ..........................................................53
Programmable terminals................... Front inside cover
Agitated thin film evaporator ......................................51
Food & non-food packed products.............................23
Proximity sensors .............................. Front inside cover
Air handling units.........................................................67
Forced circulation evaporator .....................................51
Pumps............................................................................19
Air shower controllers..................................................21
GMP heat exchangers ..................................................7
Rapid endotoxin detection system............................69
Air showers....................................................................67
GMP reactors ..................................................................7
Retro automation .........................................................27
Air tents for operation theatre ....................................67
Heart valve frames .....................................................41
RFID ................................................... Front inside cover
Analyser .........................................................................66
HPLC .............................................................................47
Rising film evaporator..................................................51
Analytical instruments .................................................47
HVAC clean room........................................................67
Rotary bottle washing machine ...................................74
Annular centrifugal extractor ......................................51
Hydrogenator/autoclaves ...............................................7
Rotary multihead screw capping unit.........................33
Automatic cream filling machine................................33
Industrial control & sensing devices .......Front inside cover
Rotary tablet press ..........................................................9
Automatic overwrapping machine..............................33
Infomedia18 B2B magazines..........................................8
Rotary vacuum dryers ....................................................7
Automatic twin head powder filling machine............33
Informatics ....................................................................47
Rotocone dryers..............................................................7
Bar code reader...........................................................66
Information technology solution ................................27
Safety light curtains ........................Front inside cover
Blender...........................................................................73
Injectable powder filling machines .............................11
Scraped surface crystalliser ..........................................51
Blow-fill seal machines.................................................17
Inspection systems........................................................25
Short path distillation unit ..........................................51
Bottle washing machine ...............................................68
Interfacing with MIS packages ....................................27
Silicone carbide heat exchangers ...................................7
Capping machines ......................................................11
Invertor/variable frequency drives ... Front inside cover
Skid mounted systems..................................................51
Centrifuges ....................................................................66
Lab equipments ..........................................................27
Sludge dryer ..................................................................51
Chill roll flaker unit......................................................70
Laminar flow work stations .........................................67
Spherical paddle chopper dryers ...................................7
CIP/SIP modules ..........................................................73
Leak test apparatus .......................................................68
Sticker (self-adhesive) labelling machines ..................11
Clean room equipments...............................................67
Level controllers................................. Front inside cover
Strip seats ......................................................................66
Clean room projects .....................................................67
Liquid filling lines.........................................................11
Sweetness enhancer ......................................................53
Clean room validations & services ..............................67
Liquid filling machines.................................................11
Switching relays ................................. Front inside cover
Coding and marking labelling machine ......... Cover on cover
Liquid-liquid extractor.................................................51
Table top coder...........................................................68
Collating & overwrapping machine ............................33
Low RH air handling unit ..........................................67
Tablet bottle packing lines...........................................11
Columns & chemistries................................................47
Machine automation..................................................27
Tablet press machine......................................................9
Conical screw dryers.......................................................7
Masking agent ...............................................................53
Temperature controllers .............Front inside cover, 15
Contamination controller ............................................67
Measuring & monitoring relay......... Front inside cover
Three parameter display unit ......................................21
Counters & power supplies............... Front inside cover
Monoammonium glycyrrhizinate ...............................53
Timers................................................. Front inside cover
Dehumidifiers.............................................................59
Motion controllers............................. Front inside cover
Turbine blowers/exhausters .........................................74
Digital panel meter .......................................................15
Multiple effect evaporator............................................51
Turnkey projects.......................................................7, 27
Door interlock systems.................................................21
Packaging machines ...................................................11
Twin-screw co-rotating extruders ...............................41
Drives.............................................................................bc
Packaging solutions for FMCG ...................................23
Twin-screw elements ....................................................41
Dry syrup powder filling lines.....................................11
Paperless recorder.........................................................15
Twin-screw extruders ...................................................41
Dryer..............................................................................67
Pass box interlock systems...........................................21
Ultrasonic flowmeter .................................................15
Electrical (both HT & LT)..........................................21
Photoelectric sensors ......................... Front inside cover
UPLC .............................................................................47
Empower .......................................................................47
Plant automation solutions..........................................27
Vacuum pump inlet/exhaust trap.............................70
Encoders ............................................. Front inside cover
Plant-wise SCADA solutions .......................................27
Ventilator ......................................................................69
ERP/SAP/LIMS/DMS clinical database systems.........27
PLC/SCADA/DCS systems...........................................27
Vibratory finishing systems .........................................69
Exhibition - Healthex 2010..........................................10
Process controllers........................................................15
Vision inspection system..............................................27
Factory automation.............................. Front gate fold
Process heat exchangers .................................................7
Vision sensors .................................... Front inside cover
Falling film evaporator.................................................51
Process reactors...............................................................7
Washing and air jet cleaning machines....................11
Fire alarm ......................................................................21
Programmable logic controllers ....... Front inside cover
Wet glue labelling machine .........................................11
PRODUCT SOURCING MADE SIMPLE July 2010
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Techno Force Pvt Ltd
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Charles River
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