Modern Pharmaceuticals - July 2011 by Infomedia18

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Editorial

The ‘H’ factor

ith the annual turnover (from domestic sales and exports) inching towards the $23-billion mark along with a steady double-digit growth rate, the Indian Pharma Inc never had it so good. Furthermore, according to a report by McKinsey, the country is poised to rank among the top 10 markets of the world by 2015. Amid this extensive growth and given the knowledge-intensive nature of pharma business, the strategic role of human resources cannot be overemphasised. There are multiple perspectives to this evolving success story. While the present opportunities and future prospects make a bright case for a successful career in pharma, the challenge seems to be in not only recruiting the right talent with the required experience but also retaining these resources for a reasonable time. The span of requirement ranges from workforce in research to manufacturing, marketing to supply chain management, among others. One of the key questions facing the pharma industry today is getting the ‘employability quotient’ right among the new joinees. To bridge this apparent gap between academic curriculum and industry’s requirement, it is imperative to fortify the former with specialised courses in the

fields of drug discovery, clinical research, quality assurance and regulatory affairs in line with global practices. This will go a long way in not just filling up the talent gap in the country, but also help India become a global talent pool for the pharma industry. For more on this soft yet critical part of the pharma value chain, where both value and volume matter, turn to ‘Market Trends’. That said, the last-mile connectivity is as crucial for pharma as for other sectors. To elaborate, availability and accessibility of pharma products at the right place and right time can make a key difference in a brand’s success. Especially with rural penetration being high on the priority list of the pharma industry, an effective supply chain management is the need of the hour. However, a lot is desired in terms of warehousing, transportation and distribution to provide an uninterrupted and cohesive pharma supply chain in India, which is currently highly fragmented and unorganised. ‘Industry Update’ offers a detailed insight into this. Read on…

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Editor: Manas R Bastia

July 2011 I Modern Pharmaceuticals

Contents FE AT URES 30

LEADERS SPEAK 'It is believed that counterfeiting in India is largely present in rural areas, and not so much in the cities' ...says Ashifi Gogo, CEO, Sproxil

ROUNDTABLE Missing the bullseye: Are pharma companies spending more on marketing than research?

IN DIALOGUE 'The Indian R&D is gearing up; however, investment in core innovation is still low’ ...says Dr Panchapagesa Murali, MD & CEO, Evolva India

FACILITY VISIT ACG Inspection: Offering tailor-made solutions for Indian pharma

INDUSTRY UPDATE Unclogging supply chain in pharma: Need to enhance communication

INTERFACE 'Pressure to enforce more anti-counterfeiting features in products, non-tariff barriers and quality standards will force the industry to increase prices’ ...says Angelos Orfanos, President and Global Head of Life Sciences & Healthcare, DHL GCS

MARKET TRENDS

MARKETING

Human capital in pharma: Making the right choice Drug marketing: Building a symbiotic relationship between the doctor and MR Dr Rajan T D, Pharma Consultant & Practising Dermatologist

CLINICAL RESEARCH Outsourcing knowledge-based skills: Medical writing on the radar Dr Rajesh Pandey, Senior Manager, Medical Writing, SCEDAM, SIRO Clinpharm Pvt Ltd

INTERFACE

60 64

'Peristaltic pumps can handle a wide variety of fluids-including fluids that are sterile, shear-sensitive, highly viscous or chemically aggressive’ ...says Philip Nyren, Product Group Manager, Cole-Parmer 'High precision analytical instruments are not presently manufactured in Indiaand the industry still relies on import’ ...says Dr K V Krishnan, Practice Head, Life Sciences, Mindteck

INDUSTRY INSIGHTS Global cancer vaccines market: High unmet needs Courtesy: GlobalData

CASE STUDY Vision sensors for pharma manufacturing: Raising the bar for quality assurance Didier Lacroix, Senior Vice President, Worldwide Sales & Marketing, Cognex Inc

REGUL A R SEC TIONS Editorial .........................................................11 National News...............................................14 World News...................................................20 Tech Updates.................................................26 Events Calendar.............................................75 Technology Transfer ......................................77 Book Shelf .....................................................81 Product Update ............................................82 Product Index ................................................86 Advertisers’ List.............................................87

TECH MANTRA ERP systems upgradation: Improving performance, achieving sustainability Courtesy: Grantek Systems Integration, a Rockwell Automation Solution Provider

Highlights of Next Edition: Industry Update Pharma outsourcing/CRAMS

Details on page no.

Market Trends Clinical research organisations Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818. Modern Pharmaceuticals I July 2011

National News FDASmart organises conference on M&As FDASmart Inc held its one-day conference at the ITC Grand Central Hotel, Parel. This event focussed on the recent trends in global Mergers and Acquisitions (M&As) of Indian pharma and biotech companies especially with cross-border deals.

Further, Chris Barnett, a London-UK based Qualified Person (QP) who worked in India in the past depicted a positive picture of how Indian pharma have changed for the better but quality challenges remain to be tackled if Indian pharma is Ranjit Shahani Takeaways… indeed to globalise. Dr Kiran A group of world-class speakers were Marthak, Member of Board of Directors, assembled for the event and featured Veeda Clinical Research, discussed high Deloitte India as knowledge partner profile M&As with CRO companies with Ranjit Shahani, Managing Director, and summarised the net results to the Novartis India, as keynote speaker. Shahani CRO industry as these M&As progress in his keynote address described the with time. Vishal Gandhi, Vice President pharma industry as seen from the eyes & Head, Life Sciences Banking, Yes Bank, of an India-based multinational pharma highlighted on the various kinds of company’s CEO. Other speakers included financing options available for upcoming Sumit Ghoshal, Deputy Editor, Business and medium-sized life science companies India, who discussed why the recent in India at present, the associated pros Foreign Direct Investment (FDI) curb on and cons from a company’s perspective pharma M&As need not be feared. He and the near-term outlook for these was followed by other speakers such as opportunities. This was followed by Dr Milind Antani, Head, Pharmaceutical a panel discussion that noticed the and Life Sciences, Nishith Desai Associates. presence of Indian pharma companies in Attani elaborated on legal and Intellectual tier I and tier II cities, legal and advisory Property (IP) aspects on pharma M&As life sciences scenario, private equity with another associate Simon Reis. investors in pharma, etc.

Sun Pharma announces USFDA approval for generic Imitrex® injec on Sun Pharmaceutical Industries Ltd, recently announced that US Food and Drug Administration (USFDA) has granted its US subsidiary an approval to market a generic version of sumatriptan succinate injection. This is the first Abbreviated New Drug Application (ANDA) approval for a sumatriptan auto injector. The pharmaceutical company has got the permission to market this injection in strength of 6 mg (base)/0.5 m. Annual sale for sumatriptan succinate injections in the US is approximately $190 million. Sumatriptan succinate injection is indicated for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes. This generic injection packaged in a single-dose syringe with autoinjector is equivalent to Imitrex® STATdose System, 6 mg (base) / 0.5 mL of GlaxoSmithKline.

Bausch + Lomb ventures into the Indian pharmaceu cal market Bausch + Lomb, the global eye health market in India, which is expected company, recently announced its entry to reach $300 million by 2015. into the growing Indian pharmaceutical In addition to gaining access to market by signing a Memorandum world-class manufacturing capabilities, of Understanding (MoU) with Micro Bausch + Lomb will establish dedicated Labs India, a leading provider of sales and marketing teams. quality healthcare products. With this With the help of this collaboration collaboration Bausch + Lomb will be Bausch + Lomb will be launching finally entering the Indian pharma six pre- and post-operative eye drops in India namely, Moxisurge™, market after having a presence in the Aquasurge Max™, pharmaceutical vertical worldwide L-R: Surana, Rodney W Unsworth, President, Asia- Aquasurge™, for over two decades. “Our company Pacific, Rick A Heinick,Corporate-VP, Global Human Bromvue™, Ketovue™ and Moxisurgeentered the pharma vertical in the year Resources & Transformation; Dr Calvin Roberts, KT™. While the manufacturing of these products will be taken care 1986 but at that time there was less Corporate-VP & CMO, B+L confidence in the Indian pharma market from the company’s of by Micro Labs, Bausch + Lomb will look into setting up side, and also we did not get any good collaborative opportunity of quality processes, co-vigilance system and other such like this. So we were just waiting for the right moment and the processes. “It gives us immense pleasure to partner with right opportunity,” said Harish Natarajan, Managing Director, Bausch + Lomb, the most powerful brand in eye health as they enter into the pharmaceutical segment in India,” said Anand Bausch + Lomb India. Through the agreement with Micro Labs, Bausch + Lomb aims to Surana, Director, Micro Labs, India. - Titash Roy Choudhury capture part of the rapidly expanding ophthalmic pharmaceuticals 14

Modern Pharmaceuticals I July 2011

National News Indian biopharma R&D spending could grow to $25 billion by 2025 India’s biopharma sector may see a surge in R&D spending to about $25 billion in the next 15 years, according to a Boston Consulting Group (BCG) report that said favourable policies need to be implemented to attract investment and enhance innovation in the field. The paper was presented at the US-India Bio-Pharma summit organised by the USA-India Chamber of Commerce (USAIC) on June 24, 2011.

The total amount that is currently being spent on innovative discovery programmes and development in the biopharma sector in India is about $2 billion. This amount can grow to $25 billion by 2025 if concerted efforts are made by various stakeholders like the government, academia and industry on developing R&D and innovation in the biopharma field.

The investment is expected to come from multinationals, Indian industry and funding organisations ploughing money into discovery and innovation. “The Indian government needs to implement favourable policies that enhance innovation and drive collaborations, besides addressing issues in critical building blocks like talent and infrastructure,” BCG stated in its position paper, titled, ‘Life Sciences R&D: Changing the innovation Equation in India.’

Six Indian ﬁrms to enter the US generic drug market

India’s Themis Medicare brings mPedigree technology to India

Six Indian pharma majors will be entering the US generic market for Levaquin (levofloxacin), an antibiotic approved for treating bacterial infections. Oral and injectable forms of levofloxacin have been approved from 12 manufacturers, including six Indian companies; Aurobindo, Dr Reddy’s, Glenmark, Lupin, Torrent and Wockhardt. Levaquin reported annual sales of $1.3 billion in 2010 and $422 million in the first quarter of 2011. Levofloxacin is used to treat mild, moderate or severe bacterial infections of the skin, sinuses, kidneys, bladder and prostate caused by specific germs, and those which causes bronchitis or pneumonia. It is used to treat those exposed to inhalational anthrax. “FDA-approved generic drugs must meet rigorous standards and are required to be of high quality,” said Keith Webber, Deputy Director Pharmaceutical Science, USFDA - Center for Drug Evaluation and Research. Dr Reddy’s and Lupin have announced the launch of the tablets in the strengths of 250 mg, 500 mg and 750 mg.

Themis Medicare, one of India’s leading research-based healthcare companies, has recently announced an agreement with multiple award winning social enterprise, mPedigree Network, which shall see consumers of Themis’ life-saving drugs verifying the authenticity and quality status of their Themis’ brands for free via mobile phone text-messaging technology. The partnership also marks the much-awaited introduction of the mPedigree instant authentication technology platform to the Indian pharma industry after years of intensive feasibility studies and relationship work. Themis Medicare thus joins an elite group of companies globally that have deployed mPedigree’s best-inclass cloud computing platform, managed and deployed by global technology leader Hewlett Packard, to protect and reassure their customers about the quality and safety of their pharmaceutical brands, using free text messages and unique scratch codes. Dr Dinesh Patel, CEO, Themis Medicare, remarked, “We recognise that increasing concerns about quality and safety requires that we must go an extra mile. It will be like keeping in place our philosophy, ie, to create means for our customers to be absolutely reassured that the medicine they are receiving satisfies the high and uncompromising standards of quality we hold dear, whatever the channel through which it was delivered, and that under no circumstances could that promise of quality be compromised”.

Lupin, Natco e-up to market breast cancer tablets Lupin Ltd and Natco Pharma have formed an alliance to jointly commercialise generic lapatinib ditosylate tablets used for the treatment of breast cancer in the US market. Lapatinib ditosylate tablets are sold under the brand name Tykerb in the US market. The patent of Tykerb is with Glaxo. Natco had filed an Abbreviated New Drug Application (ANDA) seeking US Food and Drug Administration (US FDA) approval for marketing generic equivalent of Tykerb® in 250 mg tablets. Lupin, the 5th largest and the fastest growing top 5 generics player in the US (by prescriptions), the only Asian company to achieve that distinction along with Natco, believes that they are first-to-file an ANDA containing a Paragraph IV certification for Lapatinib. Tykerb® had sales of $113.6 million as of March 2011 according to IMS health. July 2011 I Modern Pharmaceuticals

National News J B Chemicals enters gynaecology and dental division Drugmaker J B Chemicals & Pharmaceuticals has announced the launch of a new business division catering to gynaecology and dental therapies with 15 products, and would exploit other therapeutic areas having good growth potential, sending its shares up by over 7 per cent. The gynaecology and dental segments have a combined market size of about `2,000 crore in India and are growing at 16 per cent every year. The new division has a sales force of over 100 representatives and it would triple the count over the next two years, it added. The launch would help company strengthen its position in the rural as well as urban markets in India. Pranabh Mody, President, J B Chemicals, had stated in May that the company would launch at least 15 new products from gynaecology and dental division in India this year and would concentrate on Contract Research and Manufacturing Services (CRAMS) business post the deal with Johnson & Johnson. The company sold its over-the-counter medicines business in Russia to an affiliate of Johnson & Johnson for about $260 million. The brands include Rinza, Russia’s leading multi-symptom cough and cold brand, and Doktor Mom, Russia’s No 2 cough brand.

IDDCR and Temple School of Pharmacy presents global cer ﬁcate programmes in India International Drug Discovery and Clinical Research (IDDCR) and the prestigious Temple University’s School of Pharmacy (TUSP), US, have joined hands in the delivery of global certificate programmes to India. Starting in late August, IDDCR will bring Temple University’s globally recognised Quality Assurance/Regulatory Affairs (QA/RA) graduate programme to students in Hyderabad, offering one-year Post Graduate Diploma Programmes that cover key concepts in the pharmaceutical industry. IDDCR intends to educate 80-100 select students in clinical trial management and global pharmacovigilance each year. The certificate programmes will help ease the demand for high-quality clinical trial and pharmacovigilance professionals from big pharma, start up, generic drug, biotechnology, and clinical research organisations in India. Founded in 1884 in Philadelphia, PA, Temple University is the sixth largest provider of professional education in the US, and its QA/RA graduate programme is the oldest and most comprehensive of its type in the world. IDDCR provides practical training and resources for global biotech and pharmaceutical companies. Vamsi Maddipatla, CEO, IDDCR, said, “Various centres and institutions currently offer certification, but this initiative by IDDCR-Temple creates the only fully industryfocused certificate programme in clinical trials and pharmacovigilance in India.”

Jubilant Biosys receives milestone payment from AstraZeneca Jubilant Biosys, a unit of Jubilant Life Sciences, recently announced that it has received an undisclosed amount as a milestone payment from AstraZeneca for its research on pain management in the neuroscience therapeutic area. “The collaboration, which was initiated two years ago in neuroscience therapeutic area, has now expanded to cardiovascular and metabolic diseases and focusses on the delivery of a steady stream of pre-clinical outcomes to

AstraZeneca by Jubilant,” stated a press release by Jubilant Life Sciences. Commenting on the development, Sri Mosur, CEO & President, Jubilant Global Drug Discovery and Development, said, “We are pleased that we have delivered outcomes and early success to the portfolio efforts at AstraZeneca. This is the result of excellent collaboration between scientists at Jubilant and AstraZeneca.” The alliance between

Jubilant and Londonheadquartered drug firm AstraZeneca in the neuroscience therapeutic area began two years ago. AstraZeneca owns the compounds developed under the collaboration with worldwide development and commercialisation rights. On the other hand, Jubilant derives research funding and successbased development and commercialisation milestone payments, added the press release.

Aurobindo Pharma receives ﬁnal approval for alprazolam extended-release tablets

Aurobindo Pharma Ltd has announced that it has received final approval from the US FDA to manufacture and market 16

alprazolam extended-release tablets in the quantities of 0.5 mg, 1 mg, 2 mg and 3 mg. Alprazolam extended-release tablets that would be manufactured and marketed by Aurobindo pharma is the generic equivalent to the reference listed drug Xanax® XR Tablets 0.5 mg, 1 mg, 2 mg and 3mg of Pharmacia and Upjohn.

These tablets are used for the treatment of panic disorder, with or without agoraphobia and fall under the Central Nervous System (CNS) therapeutic segment. The product has a market size of approximately $26.5 million for the twelve months ending September 2010 according to IMS and will be launched soon. Modern Pharmaceuticals I July 2011

National News Sproxil launches its opera ons in India Sproxil Inc, a world-class brand protection company recently announced the launch of its operations in India. With the help of its brand protection product, Mobile Product Authentication™ (MPA™) the company will focus to check the growing drug counterfeiting in India. The announcement was made by Dr Ashifi Gogo, CEO, Sproxil Inc. It enables consumers to verify the authenticity of a pharmaceutical product by sending the unique code on the drug as a free text message to the manufacturers, in real time. “Our MPA™ architecture combines secure interlocking technologies and makes counterfeiting unprofitable,” said Dr Gogo. “This operation will be launched in Mumbai and Bengaluru initially, as more than 80 per cent of the Indian pharmaceutical manufacturers are based in the West and the South of India,” said Dr Gogo. Brand and product pirates in Indian markets pose a significant risk to legitimate Indian manufacturers, leading to brand degradation, decrease in sales and consumer purchasing apprehension. Through Sproxil’s offerings, companies can protect consumers from harmful products.

Glenmark receives ﬁnal USFDA approval for mupirocin Glenmark Pharmaceuticals has recently announced that it has received final approval from USFDA for its generic mupirocin ointment, used for the treatment of skin infections. The US subsidiary of Glenmark Generics, has been granted a final Abbreviated New Drug Approval (ANDA) from USFDA for mupirocin ointment USP 2 per cent, the company said in a statement. Based on IMS health data for the 12-month period ending March 2011, mupirocin ointment, used in treatment of bacterial skin infection impetigo, garnered annual sales of $55 million and achieved a 9 per cent increase in growth compared to the same period last year. The ointment is available in a 22-gram tube. The company has 39 ANDAs pending for approval and has a portfolio of 68 products for distribution in the American market.

Bristol-Myers Squibb signs agreement to expand access to Reyataz® in India Bristol-Myers Squibb (BMS) has recently signed a immunity-from-suit agreement with Matrix Laboratories Ltd to expand access to Reyataz® (atazanavir sulfate). This agreement will enable the generic company to manufacture and sell atazanavir as well as stavudine and didanosine in India and sub-Saharan Africa. Atazanavir is an important component of HIV combination therapy

and this agreement will facilitate broader availability of the medicine in the developing worlds. This is the fifteenth agreement that BMS has signed for

its HIV medicines, and the fourth for atazanavir. A key component of the agreement is the inclusion of paediatric formulations of the medicines to support the treatment needs of children with HIV. WHO prequalification enables procurement organisations to purchase medicines using funding from United Nations agencies and the global fund to fight AIDS, tuberculosis and malaria.

Marck Biosciences launches paracetamol IV in plas c pack in India Marck Biosciences Ltd, India’s leading manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, is ready to launch world’s first ever paracetamol IV in plastic pack manufactured using BFS technology in India. Marck will be contract manufacturing paracetamol IV and will also launch it under its own brand name of ‘Febramol IV’ in India. Paracetamol IV is a ready to infuse dosage form of paracetamol (in 10 mg/ml solution), which is indicated for the short-term treatment of moderate 18

pain, especially following surgery and for the shortterm treatment of fever urgently when other routes of administration are not possible. Paracetamol IV in plastic has lower freight costs and breakages and helps in more competitive pricing in comparison to glass bottles. Marck has invested approximately $3.5 lakh to commercialise the production of paracetamol IV and expects growth of approximately $1 million sales with paracetamol IV in the first year of its launch.

Speaking on the occasion, Bhavesh Patel, MD, Marck Biosciences, said, “Due to our proven ability to innovate and create a pack that further reduces the potential for microbial infection during manufacture, and our R&D team’s dedicated efforts for 3 years, Marck has overcome the challenge of developing Paracetamol IV in blow–fill-seal pack and launched this product for the first time in the world.” The company has already pioneered the export of paracetamol IV to West Africa, South East Asia and Middle East markets, and will now launch it in the Indian markets. Modern Pharmaceuticals I July 2011

World News Another Tylenol recall Tylenol extra strength caplets became the latest in a long succession of Johnson & Johnson products to be taken off the shelves after complaints of the pills’ ‘musty odour’. According to McNeil Consumer Healthcare, the US pharma giant recalled 60,912 bottles of the drug after customers criticised the product’s scent, comparing it to that of mold. The odour has been linked to the presence of trace amounts of a chemical known as 2,4,6-

tribromoanisole (TBA), a by-product of a preservative sometimes used on wooden shipping pallets. McNeil insist the move was based on only a ‘small number’ of complaints and added, “This voluntary action is being taken as a precaution and the risk of adverse medical events is remote.” However, experts are now pondering the safety of purchasing over-the-counter medicines from the J&J brand.

Waters Corpora on and Premier Bioso Interna onal collaborate for lipidomics research

Pﬁzer gets $800 million boost for Lipitor

Waters Corporation has recently announced its entry into a non-exclusive co-marketing and reselling agreement with Premier Biosoft International. This collaboration is to conduct advanced lipidomics research. Waters will offer Premier Biosoft’s SimLipid informatics platform for sale with Waters Acquity UPLC and high-resolution, exact mass SYNAPT and XEVO mass spectrometers for lipid analysis. Premier Biosoft released its SimLipid software product earlier in 2011, which generates portable reports and images in different file formats such as xls, csv, html, jpeg and png to facilitate dynamic information sharing. In addition, each structure is mined for its associated class, reaction, pathway and enzyme, so that scientists do not waste time and money on laborious manual annotation. This technology would provide high levels of specificity, liquid analysis along with separation of isobaric/isomeric liquid species. “Waters UPLC, ion mobility, advanced mass spectrometry and informatics technologies have created a lipid analysis platform, which provides greater insight into our complex biological investigations than ever before,” said Professor Jeremy K Nicholson, Head of Surgery and Cancer, Imperial College London, Waters Center of Innovation.

Pfizer could earn $800 million after European Union (EU) countries extended exclusive rights to sell its most popular drug Lipitor until May next year in exchange for tests that will provide a slightly modified version to a few thousand children. The US pharmaceuticals group will launch a chewable grape-flavoured low-dose version of its cholesterollowering drug Lipitor in the EU in November, when the patents are due to expire, exposing the drug to cut-price generic competition. But under EU regulations designed to encourage research into medicines for children, Pfizer has sought a ‘supplementary protection certificate’ in most EU countries, extending its monopoly over supplies and pricing. According to IMS, the top five European markets alone account for 14 per cent of Lipitor’s $11 billion in annual sales, indicating a six-month extension is worth $770 million. Few expected the system would provide drug companies with returns on the scale to be earned by Pfizer. The additional tests it has carried out have not led to significant changes in the drug’s authorised uses. Much of Pfizer’s profit in recent years has come from Lipitor, which accounts for about a fifth of total sales, so the expiry of the patents presents the company with a hefty challenge. Lipitor has gone off patent in Spain, Finland and Norway but remains protected across most of the EU markets.

WTO rules against China in raw material export quota case A World Trade Organization (WTO) panel has ruled China’s export limits on raw materials, including some with pharma uses, as unfair after claims they drive up prices. In 2009, the US and Europe followed by Mexico, began a WTO dispute claiming export restrictions disadvantage foreign companies by driving up prices. This, in turn, gives Chinese companies an advantage, said the complainants. A panel was appointed for the same. They sided with the complainants and recommended that China stops levying the export duties and quotas. Ron Kirk, US trade representative, said, “China’s policies provide substantial competitive advantages for downstream Chinese industries. They have also caused massive distortions and harmful disruptions in supply chains throughout the global marketplace.” Raw materials covered by the ruling include zinc, magnesium, manganese, bauxite, coke, fluorspar, silicon carbide, silicon metal and yellow phosphorus. 20

Modern Pharmaceuticals I July 2011

World News FDA ponders Avas n’s future for breast cancer An eagerly anticipated two-day hearing into Roche’s appeal against the USFDA proposal to pull Avastin’s approval for breast cancer has brought more activity at the agency’s headquarters in Maryland. After a review of four clinical studies, FDA concluded Avastin (bevacizumab) in combination with paclitaxel neither prolonged overall survival in metastatic breast cancer patients nor provided a sufficient benefit in slowing disease progression. The decision was followed by a review by the FDA advisory committee, which suggested removal of the breast cancer indication. Avastin in combination with paclitaxel got the green light in February 2008 under the agency’s accelerated approval programme. Roche strongly disagreed with the decision and breast cancer patients have been testifying to an FDA panel. However, the FDA is unlikely to change its stand, seeing as how especially as five of the six members of the panel also voted against Avastin’s use in breast cancer in July.

Amgen and UCB team up with NASA Amgen and UCB (Euronext Brussels, UCB) have collaborated with National Aeronautics and Space Administration (NASA) to conduct a test of an antibody called sclerostin. This experiment would be conducted in space shuttle Atlantis on the final shutter mission of NASA, which was scheduled to be launched on July 8, 2011. The antibody is going to be designed to inhibit the action of sclerostin- a protein that acts as a regulatory for bone formation, bone strength and bone mass. The findings from the research would help provide an insight into the prevention and treatment of

skeletal fragility that can result from ‘skeletal disuse’ in conditions such as immobilisation, stroke, cerebral palsy, muscular dystrophy, spinal cord injury and reduced physical activity. As loss of bone mass during space flights is one of the major concerns of the human space mission as it causes a lot of discomfort especially for people in long flights. AMG 785/CDP7851, a different sclerostin antibody than the one being used for this STS-135 mouse study, is currently in phase II clinical trials for bone-related conditions, including postmenopausal osteoporosis and fracture healing.

Merck collaborates with academics on HIV research Drugmaker Merck & Co Inc has announced that it will collaborate with the researchers at the University of North Carolina, the University of California and other academics on HIV research. A team of academics led by professors at the University of North Carolina Chapel Hill campus and assisted by Merck will research ways to purge HIV infections from the body. Another team of academics centered at the University of California San Francisco will research HIV reservoirs, areas where the virus may lie dormant. The National Institutes of Health is the primary funding organisation for both efforts. Merck said it will not receive federal funding for its participation.

GSK’s Boostrix receives FDA approval GlaxoSmithKline’s booster vaccine, Boostrix has been approved by the US FDAto be used as a single dose booster vaccine to treat tetanus, diphtheria and whooping cough in people over 65 years of age. Boostrix has already been approved by the FDA for adolescents between 10 to 18 years of age and for adults aged between 19 to 64 years. FDA said that this will be the first vaccine to provide protection against all three diseases among the elderly. With this approval, adults 65 and older now have the opportunity to receive a vaccine that prevents pertussis, as well as tetanus and diphtheria, said Karen Midthun, FDA.

Nichrome bags its ﬁrst order for HFFS machines in Germany capsules & tablets, and swabs & tissues besides Nichrome India Ltd launched their first conventional applications like powders and indigenously manufactured Spanish technology liquid. They bagged their first order for HFFS machine along with its high speed multilane the displayed T110 HFFS machine in the sachet machine with US technology at the world’s exposition and were approached by USA, Asia, biggest packaging exposition Interpack 2011 at Middle East and Europe and other Western Dusseldorf, Germany in May this year. markets. Nichrome TOTPACK HFFS machines will “It was the combination of advanced Spanish manufacture products such as cosmetics, (L to R): Joquim Miro (TOTPACK), pharmaceutical powders, juice concentrates, Harish Joshi (Nichrome) and Bruce technology and credible Indian manufacturing dry fruits, liquid chemicals & gels, capsules & Teeling (Prodo Pak) at Interpack 2011. that brought our machine to sell for itself. tablets, swabs & tissues, etc. Whereas Nichrome Nichromes’ both technology tie-ups with Prodo-Pak High Speed multilane Sachet Machines will promote Spanish and US were well received,” informed Vaibhav Modak, cosmetics & personal care, pharmaceuticals & nutraceuticals, Executive Director, Nichrome India Ltd. 22

Modern Pharmaceuticals I July 2011

World News Harvard Medical School Faculty advances drug safety research with IBM business analy cs IBM has recently announced that the faculty from Harvard Medical School and Brigham & Women’s Hospital would be using IBM business analytics technology for a new research that would examine the effectiveness of prescription drugs and identify potential safety issues. Harvard Medical research

teams are conducting advanced pharmaco epidemiology studies that look at the effects of drugs in large numbers of people based on insurance claims data. Using an IBM Netezza data warehouse appliance, the research teams will expand their study to analyse data from millions of de-identified patient records

with the aim to develop new dataintensive drug safety research methods. “The ability to glean insight and act on the analysis of massive amounts of claims data will help Harvard Medical School extend its reputation as one of the largest and most respected medical research organisations in the world,” said Arvind Krishna, General Manager, IBM Information Management.

Shire and Acceleron Pharma collaborate to treat orphan muscle diseases Shire, the global specialty biopharmaceutical company, announced the expansion of its human genetic therapies pipeline through the exclusive licence, in markets outside of North America, for the activin receptor type IIB (ActRIIB) class of molecules being developed by Acceleron Pharma Inc, a private biotechnology company based in Cambridge, Massachusetts. The association will initially investigate

ACE-031, Acceleron’s lead ActRIIB drug candidate, which is currently in phase 2 of the trial for the treatment of patients with Duchenne Muscular Dystrophy (DMD). DMD is a fatal orphan muscle disease with no current treatment. ACE-031 and other ActRIIB molecules have the potential to be used in other muscular and neuromuscular disorders. Shire and Acceleron will collaborate on a worldwide development

GlaxoSmithKline in pact with World An -Doping Agency Olympics 2012 partner, GlaxoSmithKline, has signed a longterm agreement with the World Anti-Doping Agency (WADA) to create early detection method for medicines with performanceenhancing potential in sport. Under the agreement, GSK scientists would specifically identify substances with a probable or high risk of abuse in sport. These scientists would seek similarity to the pharmacological characteristics of existing performance-enhancing substances and analyses their reaction in the human body. This would include stimulatory effects or improved physical endurance. The historic partnership, which was officially ratified in London on June 23, will see GSK supply WADA with confidential information about medicines in early stage development that will be abused by athletes once they are licenced for appropriate patient use. John Fahey, President, WADA, said, “Our work with the pharmaceutical industry is critical to staying one step ahead of the dopers, who have an ever increasing level of scientific expertise. We are delighted to be entering into this partnership with GSK as it will play a significant role in helping WADA achieve its mission of a doping-free sporting culture.” 24

programme to advance ACE-031 into a global phase 2/3 clinical programme designed to exhibit disease modification in DMD patients. They would utilise the facility to produce commercial supplies of the product for both parties Shire will also make a payment of $45 million to Acceleron, who is also eligible to receive additional development, regulatory and sales milestone payments of upto $165 million.

IMI announces a new total of 23 unique projects to boost drug innova on The largest public-private partnership in the biopharmaceutical sector, Innovative Medicines Initiative (IMI) launched its second wave of research projects, which includes cancer, immune-mediated diseases, infectious disorders and electronic health. With 23 projects up and running, over 450 million is now committed by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) on a uniquely large scale. IMI would now be sharing their current as well as future R&D with Europe. Máire Geoghegan-Quinn, Commissioner for Research, Innovation and Science, said, “By speeding up drug development across Europe, investments made by the IMI will ultimately save and improve lives, as well as make a major contribution to the Innovation Union and to growth and jobs.” Modern Pharmaceuticals I July 2011

World News Nasal spray vaccine for diabetes developed Researchers from Australia have developed a pioneering inhaled spray designed to stop the onset of type 1 diabetes. The diabetes prevention spray vaccine is presently being put through clinical trials and has already produced positive results from mousebased trials. 52 participants, all aged over 18, are taking part and all have early-stage type 1 diabetes. The nasal vaccine has shown to be successful in human type 1 diabetes, could also be tested with different vaccines for the prevention of other autoimmune diseases such as rheumatoid arthritis and multiple sclerosis Type 1 diabetes is caused when the immune system turns on the beta cells responsible for manufacturing insulin and, as a result, glucose levels in urine and blood surge. These patients are therefore generally prescribed a daily supply of insulin via injection, to bring glucose levels back down.

OncoTrack: A new Interna onal consor um launches project in the area of genomic cancer diagnos cs OncoTrack, an international consortium, managed by Bayer HealthCare Pharmaceuticals and the Max Planck Institute for Molecular Genetics launched one of Europe’s largest academic-industry research projects to develop a novel approach for identification of new markers for colon cancer. Their prime objective is to establish new methods for systematic next generation oncology biomarker development, with the intention to generate top quality genomic and epigenetic sequence data from clinically welldefined tumours and their metastases. The data acquired from all phases of the project will enable OncoTrack to address important questions about the relationship between tumour genotype and phenotype. The project has collaborations with leading global pharmaceutical companies, such as AstraZeneca, Bayer HealthCare Pharmaceuticals, Merck, Pfizer and Roche Diagnostics, whose in-kind contributions to the project are around 25.8 million. Dr David Henderson, Principal Scientist - Translational Sciences, Bayer HealthCare Pharmaceuticals, said, “We have assembled a team of clinicians, molecular scientists, bioinformaticians and associated experts, thus creating a Europe-wide network of complementary capabilities extending far beyond the scope of a traditional ‘one-onone’ industry-academic collaboration.” July 2011 I Modern Pharmaceuticals

Tech Updates

Breakthrough in bioprocess op misa on for biologicals

New SANYO dual cooling freezer provides ul mate sample security

For new biologicals and biosimilars, the innovative SpediaNMR™ technology from Spinnovation Biologics provides a real advantage for optimising cell cultures, monitoring and standardising manufacturing processes in preparation for larger Spedia-NMR™ scale production. Within the past four months, this has been validated by 37 companies developing biologics or delivering services to this industry. This premium Nuclear Magnetic Resonance (NMR) analysis service rapidly identifies a wide selection of feed components, metabolites and toxic compounds in culture media. By comparing media profiles from different cell culture batches, Spedia-NMR™ identifies how a cell consumes and metabolises the media along the culture process. This allows the composition of the media to be fine-tuned to improve cell viability, reach highest yields of biologic product and perform rapid process troubleshooting. Talking about the value of Spedia-NMR™ in biotech companies, Dr Frederic Girard, CEO, Spinnovation, explained, “In a short term, Spedia-NMR™ will fill the gap in knowledge to strengthen and speed up cell culture development and upstream processing. Clients need to know what is going on in their cell culture and they need to know it fast.” This technology is available on a fee-for-sample or as a contract service to all biotech companies.

SANYO expands the range of dual cooling 86ºC freezers with the launch of the extra-large capacity MDF-U700VX, an upright 728 litre model that provides maximum sample security for valuable research or clinical samples. With two independent refrigeration systems SANYO dual cooling freezers maintain a reliable and uniform -86ºC ultra low temperature environment. When one cooling system suffers an unexpected failure, the other circuit will keep irreplaceable samples safely around -70ºC until service can be arranged. These features make the MDF-U700VX ideal for storing highvalue samples in the biotech and pharma industries, stem cell research and regenerative medicine, tissue banks and blood transfusion centres, and other clinical and biomedical research facilities.

Pall Allegro™ single-use mixer improves biopharm process eﬃciency

Pall Corporation, a global leader in filtration, separation and purification, introduces the Pall Allegro™ 200L single-use mixer for high-performance mixing in biopharmaceutical applications from pilot scale to full production. This is designed to provide

exceptional mixing performance for a wide range of liquid-liquid and solid-liquid mixing applications, including compounding, formulation, buffer and media preparation, and pH/conductivity adjustment. “Reduced drug development timelines, smaller batch sizes, increased safety requirements and more stringent validation guidelines are all driving the demand for single-use solutions in drug production,” said Ken Frank, Senior Vice President, Pall Corporation & President, Pall’s Biopharmaceutical Division.

Roche introduces GS FLX+ System 454 Life Sciences, a Roche Company, recently declared the launch and immediate availability of the new GS FLX+ System, an instrument capable of generating extra-long sequencing reads upto 1,000 bp in length. This new level of performance presents a major milestone in the life science’s industry, making it the first high-throughput sequencing technology to deliver millions of bases from reads with accuracy and lengths that are comparable to Sanger-based methods. The improvements in read length also translate to a 50 per cent increase in total throughput, aiding in overall run economics and further reducing the cost of large genomic projects. 26

The new GS FLX+ System is available as an instrument or as an on-site upgrade to an existing GS FLX Instrument and features a redesigned reagent compartment to accommodate the larger reagent volume of the new GS FLX Titanium Sequencing Kit XL+. An increase in the number of sequencing flow cycles, along with chemistry and software optimisation, enable read lengths up to 1,000 bp (700 bp mode). “Our team has worked tirelessly to drive forward the performance of our system and achieve true Sanger-like read lengths and accuracy,” said Christopher McLeod, President & CEO, 454 Life Sciences. Modern Pharmaceuticals I July- 2011

Tech Updates

Bio-Rad introduces magne c bead-based mul plex immunoassays Bio-Rad Laboratories Inc recently declared the launch of new magnetic bead–based multiplex immunoassays for TGF-ß, rat cytokines, rat diabetes and mouse TH17 cytokines. New assays are built on Luminex’s MagPlex platform to take advantage of the magnetic beads workflow that simplifies assay preparation and reduces variability in results. Magnetic bead–based assays are compatible with both vaccuum and magnetic wash stations as well as other Luminex xMAP platforms such as Bio Rad’s Bio-Plex 200 and Bio-Plex 3D systems. The Bio-Plex Pro rat cytokine assays and Bio-Plex Pro rat diabetes assays detect 25 rat cytokines and five rat diabetes

biomarkers, respectively. Both panels are designed to help researchers investigate mechanisms and quantify biomarkers of diseases, such as cancer, diabetes, rheumatoid arthritis, cardiovascular, Alzheimer’s and Parkinson’s disease, and of those associated with neurological disorders and inflammation. The Bio-Plex Pro TGF-ß assays detect the three isoforms of the transforming growth factor beta: TGF- ß1, TGF- ß2 and TGFß3. These assays are key to understanding the mechanism of TGF-ß signalling, which plays a major role in cancer, cardiovascular disease and fibrosis.The Bio-Plex Pro™ mouse Th17 assays comprise 11 new targets and can be coupled with Bio-Rad’s six existing Th17 assays.

Thermo Fisher Scien ﬁc launches new range of solid core HPLC Columns

Goose announces new product for serialisa on

Thermo Fisher Scientific Inc, the world leader in serving science, recently declared the release of the Thermo Scientific Accucore™ High-Performance Liquid Chromatography (HPLC) column range. Founded on state-of-the-art core enhanced technology and utilising vast experience in phase bonding and packing, these columns provide a unique chromatography solution to enhance laboratory workflow and efficiency. Containing solid core particles, which are engineered to a diameter of 2.6 µm and an average particle size distribution (D90/10) of 1.12, the Thermo Scientific Accucore HPLC column range allows high-speed, high-resolution separation, with backpressures significantly lower than those associated with Ultra HPLC. The advanced bonding technology used in Accucore HPLC columns results in excellent peak shapes through high bonding coverage and minimised secondary interactions.

Goose, a Hyderabad-based leading innovator of business reengineering solutions, has recently launched Procon™ Tracker, a new indigenously developed track and trace solution to help pharma industry meet the new regulatory packaging guideline, detect counterfeit and protect their brand reputation. Procon™ Tracker is a new addition to Goose wide range of Procon solutions adopted by several leading global pharma companies to increase business processes efficiency. Procon™ Tracker features robust encrypted serialisation and package authentication capability designed to ensure consumer safety, reduce counterfeiting & diversion and therefore meet multiple stakeholder expectations throughout the product supply chain from the point of manufacturing to consumer end. The Procon™ Tracker supports pedigree (an electronic record keeping requirement) and is capable of multi-printer interface. It also supports automated and manual lines with added competency to work offline when there are no bar code capable printers. Deb Pattnaik, Founder, Goose, said that the recent directive from the government to pharma industry to implement track and trace automatic identification process to offset counterfeits opens an opportunity for Procon™ Tracker.

Wya Technology introduces Möbius™ mobility instrument Wyatt Technology Corporation, a world leader in instrumentation for absolute macromolecular characterisation and software, recently announced that its Möbius™ electrophoretic mobility instrument can measure precise protein charges. The innovative optical design of the Möbius boosts the sensitivity of mobility measurements, enabling protein net charge characterisation at much lower concentrations than previously possible. Protein molecules carry charges that are influenced by their environment, amino acid sequence, ionic strength and the aqueous solvent pH in which they are dissolved. The net charge carried by protein molecules is of enormous scientific interest since it affects the behaviour of the molecules. As the ionic strength of the solution increases, for example, more counter ions are present in the vicinity of the protein molecules and the mobility generally decreases due to the electrophoretic effect. July 2011 I Modern Pharmaceuticals

Tech Updates

Cytori introduces Celu on 800/CRS System Cytori Therapeutics Inc, a bio pharma company, has developed the Celution 800/ CRS System that has received regulatory clearance in Europe. Adipose tissue is introduced into the tissue collection chamber, washed to remove blood and free lipid and then digested with the proprietary enzyme reagent to release the Adipose Derived Regenerative Cells (ADRCs). The ADRCs are then concentrated by short centrifugation and wash cycles before being mixed with the washed fat graft material (also currently prepared by the Celution 800). The cellenhanced graft is then ready for transplantation into the patient by the physician. The process is controlled through automated sensors and processing algorithms to ensure consistent handling of the tissue and cells. The Celution 800/ CRS System is a complete system that prepares ADRCs for clinical use. The system provides rapid, automated tissue and cell processing in an optimised reproducible system. Further, the automated tissue and cell processing reduce the manpower requirements. Again, this as a tissue delivery device and allows the surgeon have a greater control of the tissue implantation process.

Greenphire launches unique ‘Site Payment Solu on’ Greenphire, the industry leading provider of clinical payment and communication technology solutions, has recently announced the launch of its Clinical GPS technology, a unique site payment solution that streamlines and automates the clinical payment process for sponsors of all sizes. Greenphire’s Clinical GPS solution utilises a proprietary validation engine that is capable of analysing data and triggering payments to a recipient based on customisable terms negotiated within a contract. By centralising all payment activity through a technology driven system, Clinical GPS is capable of providing detailed reporting at the site, investigator and vendor level for a single study or across a number of studies. Samuel Whitaker, CEO at Greenphire comments: “Currently we are the only company to offer a centralised reporting and auditing tool for clinical trial payments.

Bio Rad introduces touch screen instruments Bio Rad Laboratories, Inc has recently launched industry leading usability with the new colour touch screens for the C1000 Touch thermal cycler, CFX96 Touch and CFX384 Touch real-time PCR detection systems, part of the Bio-Rad 1000-series product line. Researchers can use the enhanced user interface to easily edit, run and save protocols. The design allows users of the CFX96 Touch and the CFX384 Touch to view qPCR amplification traces in real time without an attached computer. The C1000 Touch thermal cycler is ideal for large high-throughput labs, core facilities, and GLP labs that value fast

turnaround time, flexibility, and adjustable throughput. The CFX96 Touch and CFX384 Touch systems combine the optical technology of the CFX optical reaction modules with the precise thermal control and usability of the C1000 Touch™ chassis. These systems are ideal for labs that value high performance, ease of use and high throughput. Researchers who would like to improve the accuracy of their real-time PCR experiments by following Minimum Information for Publication of Quantitative Real-Time PCR Experiments (MIQE) guidelines can use qbasePLUS qPCR data analysis software.

Thermo Fisher Scien ﬁc announces breakthrough workﬂow for metabolomics Thermo Fisher Scientific Inc recently announced a breakthrough workflow to overcome key analytical and informatics challenges in metabolomics. The workflow integrates new application softwareThermo Scientific SIEVE 2.0 differential expression analysis and Mass Frontier 7.0 structural elucidation software with powerful new Thermo Scientific High Resolution Accurate mass (HRAM) instruments: the Q Exactive™ high performance bench top quadrupole-Orbitrap™ LC-MS/MS and the Orbitrap Elite™ hybrid mass spectrometer. The revolutionary new products accelerate even the most complex metabolomics studies. “Progress in metabolomics has been severely impeded by data-processing bottlenecks,” said Mark Sanders, PhD, Director, the demonstration and application laboratories, 28

Thermo Fisher Scientific in North America. “The new capability in SIEVETM 2.0 software eliminates the most significant bottlenecks in current metabolomics data-processing, enabling scientists to find the most promising putative biomarkers quickly.” SIEVE™ software is an automated solution for label-free, semi-quantitative differential expression analysis of proteins, peptides and metabolites. Using this software to pre-filter the high-quality accurate mass data generated by Thermo Scientific mass spectrometers greatly reduces the number of compounds that need to be identified, increasing the throughput of complex biomarker discovery experiments significantly. SIEVE software is expanded to address each of the most time-consuming challenges in metabolomics. Modern Pharmaceuticals I July- 2011

Leaders Speak

‘It is believed that counterfei ng in India is largely present in rural areas, and not so much in the ci es’ …says Dr Ashifi Gogo, CEO, Sproxil Inc. He is Six Sigma Black Belt cer fied in Good Manufacturing Prac ce (GMP) and Con nuous Process Improvement. A PhD in Electrical Engineering from the Thayer School of Engineering at Dartmouth College and a double-major BA in Mathema cs and Physics from Whitman College, he is Dartmouth’s first-ev expansion of Sproxi Chandreyee Bhaumi Please share Sproxil’s What gives your comp Sproxil’s services allow en free text message that they medication. Sproxil’s Mo (MPA) technology capital exist and is readily access levels of society- namely and scratch-off lottery enables consumers to bu ones. Pharma companies increase in sales of genui understanding of the co how the company could m ourselves to in-depth and as a US corporation in 20 to make the solution avail to be significant as well, as Besides, developing n fast consumers of tec they often have not had in designing the techn technology edges out th competitors because it a chance for the intera that has long been miss We enable consumers send feedback throu an efficient platform which in turn leads to the design of bette products. Customers are not the only ones who benefit. 30

Modern Pharmaceuticals I July 2011

Leaders Speak What results in counterfei ng? Counterfeiting is a complex global problem. With the increase in drugs purchased over the Internet, a whole new kind of counterfeit product distribution chain is observed. It is unlikely that counterfeiting as a whole will vanish over the next few years, but there is hope. It can be anticipated that some countries will make a conscious decision to get rid of streets of fake pharma products. Yet, the decision to work on the issue of counterfeiting came from a non-pharma concept. The US consumers are used to seeing stickers on vegetables like tomatoes in organic stores. These are meant to ensure the safety of the vegetables, but it is difficult to say if the labels are authentic. We were encouraged by this domain but realised that there was no real market in the industry so instead turned to the pharma industry. There are non-pharma applications of our technology but in the short term, we remain focussed on growing our success in limiting the availability of fake versions of drugs under our service. Today’s pharma industry is looking for more revenue and with the dominant ‘patent cliff ’ many face with blockbuster drugs going off patent, the impetus will be on generic companies to increase manufacturing. The CEOs of these large pharma companies are likely to experience sleepless nights over the potential loss of their high margins from patented drugs. It is important to remember that it is no longer enough to merely create innovative compounds; companies must also sustain that development effort. It would be great if more attention could be paid to making drugs that improve the welfare of several million consumers in key disease areas that fundamentally affect a nation’s development.

How are pharma companies tackling counterfei ng? When a product achieves commercial success, counterfeiters enter the picture and mar the situation. Think of it this way: Win + win + win Consumers+ Government + pharma July 2011 I Modern Pharmaceuticals

(Except the counterfeiters everyone should win) Traditionally, pharma companies leveraged the limited resources to counter the menace of counterfeiting. Initially, there were ways like nano particles in the ink used to print packages and chemical analysis of the pills that could help identify fakes, but these have limitations and do not fully empower the consumer. Primarily, the success of chemical testing depends on the number of pills sent for testing. It is not a strategy that scales well. While speaking with a few pharma CEOs in India, it is believed that counterfeiting in India is largely present in rural areas, and not so much in the cities. From our experience in Africa, there may be a more even spread of presence of counterfeiting between cities and rural areas. However, as governments clamp down on counterfeiting, the fake products find their way deeper into rural areas where the long arm of the law may take a while to reach. Thus, it is recommended that the governments should enhance their enforcement activities in the fight against fakes. By law, there is a significant limit to what form of law enforcement can be carried out without the government’s help. Thus, as the private sector invests more into anti-counterfeiting, it would be helpful to see a matching investment by governments into well equipped police and customs officers to identify, arrest and prosecute law breakers.

Tell us about the investments made at Sproxil for technology upgrada on. Like any other business entity investments have played a fundamentally important role for our organisation. Acumen Fund, a non-profit global venture fund addressing poverty in South Asia and East Africa, recently invested $1.8 million to fuel Sproxil’s expansion in India. Prior to this, we received $100,000 from United States Agency for International Development (USAID) in addition to an

early-stage grant of $10,000 from Clinton’s Foundation. Besides, our clients also contribute a significant amount to our profits.

Since India also faces this global menace, how do you plan to maximise on this opportunity through Sproxil’s technology? We plan to expand cautiously, but preferably to locations wherever there is either heavy manufacturing in pharma industry or chances of heavy counterfeiting. It has a large population, with more than half of them already equipped with cell phones, so there is no need to ask consumers to buy new equipment. In this purview, Africa and India deserve considerable mention. To provide some industry figures, India makes $8.5 billion worth of drugs for export. On the other side, in a number of African countries upto 70 per cent of drugs are imported from China and India. At a microscopic view, in India, we are looking at the areas of extensive pharma manufacturing like central south (Bengaluru) and western areas (Mumbai). By following traditional trade routes between India and Africa, we are already seeing success. Till date, globally, we have signed up both large MNCs as well as Indian pharma companies who export to Africa. To ensure the continued success of our technology’s adoption, we are looking for brilliant sales people with additional technical acumen so they can explain the technology. At present, we are not looking for R&D staff as a majority of the development work has already been completed. In spite of the success we have achieved, challenges are bound to occur, they typically arise out of the complexities of global trade. If we expand too quickly, we risk spreading ourselves too thin and making key mistakes. If we grow slowly, we miss out on the market opportunity and consumers would not have the help they need to avoid fake products. It is a fine balance, and we are walking the line well at this time. MPh (chandreyee.bhaumik@infomedia18.in)

Roundtable

Missing the bullseye

Are pharma companies spending more on marke ng than research? Today, a pharma company’s strategy towards becoming a diversiﬁed global healthcare leader involves increasing innova on in R&D. However, with the large spent seen in the marke ng segment, a ques on that looms is whether the spending in marke ng more than R&D? Chandreyee Bhaumik

recent study by two York University researchers estimate that the US pharma industry spends almost twice as much on promotion as it does on R&D. The researchers’ estimate is based on the systematic collection of data directly from the industry and doctors, which shows that the US pharma industry has spent 24.4 per cent of the sales dollar on promotion, versus 13.4 per cent for R&D, as a percentage of US domestic sales of $235.4 billion. IMS Health (IMS) and CAM Group (CAM), two international market research companies that provide the pharma industry with sales/marketing data and consulting services, aided the researchers in their estimate. Further, the Pharmaceutical Research and Manufacturers of America (PhRMA) concluded that pharma companies spend $29.6 billion on R&D and $27.7 billion for all the promotional activities. Thus, it is indeed a matter of discussion whether the pharma companies are spending more on marketing than on R&D. Experts try to discern the situation.

R&D and marketing are both distinct yet essential aspects of the pharma industry. While R&D ensures that therapeutic solutions are made available, the marketing department makes the end users - doctors and patients - aware of these therapeutic solutions. In fact, to be precise, pharma companies spends are decided based on its priorities and capabilities. Sanofi has always been known for its rich R&D heritage. Further, the mission of Sanofi R&D is to address patients’ real needs – those that are either poorly covered or completely ignored - and provide appropriate therapeutic solutions. For achieving the desired goal, innovation is the integral part of any pharma company. Innovation is the heart of our research model, as it is being conducted internally, and also through acquisitions, partnerships and close scientific collaboration with academia and biotechnology research institutions. Further, Sanofi Pasteur, the vaccines division of Sanofi Group, is at the forefront of developing immunological solutions to 32

prevent diseases for every stage of life, and devotes more than 1 million to R&D every year. Again, the Group also launched a transformation programme in 2009 to make R&D an innovation driver operating in a new environment that would stimulate creativity, openness and higher performance. Further progress was made during 2010 with the appointment of Dr Elias Zerhouni - world renowned leader in the scientific community - as President, Global Research & Development, covering medicines and vaccines. And closer home, the Group has appointed Dr Raman Govindarajan as Head - R&D for India. Clearly, R&D continues to be a key focus area for Sanofi. By focusing on patients’ needs, the company intends to become the most productive R&D organisation in the healthcare sector. Aparna Thomas Senior Director- Communications and Public Affairs, Sanofi- India Modern Pharmaceuticals I July 2011

Roundtable

The two separate departments, R&D and marketing, are extremely relevant for a biotech companyâ&#x20AC;&#x2122;s growth and development. As far as Cytori is concerned, we have historically concentrated heavily on R&D. For any pharma company the R&D department is vital. Further, we have spent over $250 million in R&D, without expecting any returns and even or before we rolled out our investment plans in marketing. We believe that R&D activities of a company form the foundation of a company. Further, it should be remembered that the R&D spending is decided before the product is formed and marketing comes at the last stages of commercialising the the product.

Therefore, one cannot also deny the importance of marketing spend in this area. Marketing communication is also an equally important area as it enhances the knowhow of end users like patients. Through marketing and communication processes in a pharma companies, doctors also get intimidated about the therapy in question. This is simply the reality of the entire business. Therefore, clinical trials, development of the drug forms a large part of the progress process. And we cannot curtail the investment in this or get away with it.

Of late a lot of investment has been made in marketing than R&D. But to be accurate, it is difficult to give an exact demarcation of investments between the two departments. Actually, severe marketing is done in order to live up to the existing competition in the pharma market. However, individually, bigger companies like Ranbaxy Laboratories, Dr Reddyâ&#x20AC;&#x2122;s Laboratories and many others can afford to have an increased spending on R&D. In India, there are approximately 16,000 pharma companies and out of that total number only 20-25 are big players. Thus, it is quite natural that the total figure for the spend on marketing is more than that of R&D. But, there are enough reasons for small scale pharma

companies to invest on marketing. For them this is the question of survival. Thus, in order to reach the end users, marketing is an extremely important process. Also, R&D is fundamental for any pharma company. And with lot of drugs going off patent, there is an urgent need for a new molecule and this can only be established by a thorough R&D process. Thus, a perfect blend of apt investments in both the departments is required.

An estimated $250 billion in sales are at risk between now and 2015 because of patent expiry. And Obama administrationâ&#x20AC;&#x2122;s healthcare policy favours cheaper drugs and is also open to more good quality generics entering the US market. This again is a negative political atmosphere for the innovator pharma companies. The common man in the US has started raising voice against costly innovator drugs during this period of economic instability and is vouching openly for generic medications. In this scenario, pharma majors have always justified high cost of drugs by saying that the profits generated were consumed into fundamental research for the next novel drug. Thus, with the expected fall in profits, the axe has fallen on R&D units. With the obvious loss in revenues over the next few years, innovator pharma companies have resorted in cutting costs by targeting their R&D enterprises. State-of-theart facilities and the innumerable chemists and scientists working on newer drug entities have either been shut down or laid off.

Pre 2005 era, majority of the Indian pharma, sparing a few, were only into research. Post 2005, many companies have been forced to diversify their existing R&D into units for fundamental and collaborative research. This demands Indian companies to invest heavily into research so as to retain their edge in the drug market. This trend is new for majority of the pharma companies, who are struggling for funding these R&D projects. The output of R&D is still considered as an intangible asset, and hence, banks or financial institutions are not ready to support R&D projects. Hence, we require a government backed scheme or a venture capital fund being created to nurture and grow the Indian pharma R&D. In either case, innovators or Indian generics, at present, there is lack of spending in R&D over marketing. And this is observed for reasons that are typical and unique to either of the giants.

July 2011 I Modern Pharmaceuticals

Dr John Fraser Principal Scientist, Cytori Therapeutics Inc

Dr Lal Krishna Chief Executive Officer, Ramky Pharma City India Ltd

Dr Mandar Kubal Consultant Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC) 33

Roundtable

Certainly, Indian companies or companies in the US are investing more on marketing. While companies in the US spend approximately 24 per cent on marketing, their R&D spend is just 13-14 per cent. Considering the fact that we do not get too much data on the spending on marketing in India. Lupin spends about 8.5 per cent in R&D. I believe spending on this department is worth it. However, companies are willing to spend less on R&D as they believe that it is a cost centre expense account. There is a need to change the department into an investment centre account. An example will clearly illustrate the above fact. In a multi-storeyed building, if the base is not strong then it will not be able to withstand storms or any other form of natural calamity. Similarly, in a pharma company there has to be a substantial emphasis on research, for a long-term basis. This will be able to withstand any strong call and thereby prevent the expected failures.

However, there might be certain forces that might compel a company to spend more on R&D. In this situation, it is worth mentioning that there are many Indian companies that are operating in the US market. Their marketing processes involve comparatively less investment. Additionally, regulatory body like the US Food and Drug Administration (USFDA) supports quality by design. Therefore, if there is not effective research, US FDA will not accept application on generics product. Thus, a substantial emphasis is levied on the research aspect in order to highlight the regulations and thereby ensure the quality of the product.

First, pharma firms are multinationals and diversified; their annual reports provide no information on how much they spend on pharma marketing, as compared to the marketing of their non-pharma products, and they do not provide information about how much is spent on marketing specifically. Second, annual reports merge the categories of ‘marketing’ and ‘administration’ without delineating the relative importance of each. Finally, ‘marketing’ is a category that includes more than just promotion; it also includes the costs of packaging and distribution. Annual reports are thus far from satisfactory. Thus, it appears that pharma companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharma industry, contrary to the industry’s claim.Efficient research is one thing, but it takes a lot of profits from the few

approved drugs that make it to market to pay for all the basic research and failed development candidates that lie beneath the surface and out views of most people. It is difficult to make a case that a pharma company is R&D driven when a quick look at the income statement reveals that more money is spent on marketing and advertising than it is on R&D. It is an arms race and one can think that it has been shown that there are positive returns on marketing and advertising spend – or else it would not happen. However, bottom line profits could actually increase if one provides more money for R&D and also allows companies to focus more time and energy on portfolio management of drug pipelines.

The situation varies from place to place. As far as spend of pharma companies on marketing and R&D are concerned, the situation in India is different from that of the US. Despite several efforts by the government to emphasise on the significance of R&D, companies still seem to not have understood the worth of this department. The general psychology of the average investor is that they lay more stress on the commercial benefits of the product and thus they spend more on marketing. Piramal Life Sciences Ltd and Sun Pharma Advanced Research Company (SPARC) are the research oriented endeavours of two pharma companies. However, unfortunately, it has been seen that the advanced research centres did not really create too much value. Investors are yet to comprehend the value of the R&D investment.

Everyone is interested in the tax benefits derived from the products and focus on the marketing side of the industry. However, it can be hoped that with the passing time a change is bound to occur. Today, it is seen that the value derived from generics is limited. Thus, in this arena, innovation is sure to happen since innovation is a natural phenomenon in the US and Europe. With globalisation there will definitely be trend setters who will change the dynamics of the entire pharma scenario. One will not be able to ascertain by when there will be a change, but surely a definite change is to come.

Dr Shirish Kulkarni Vice President-Advanced Drug Delivery Systems, Lupin Ltd

Shruti Pande Clinical Research Associate, International Clinical Research, Wockhardt Ltd

Vikram Gupta Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd Modern Pharmaceuticals I July 2011

In Dialogue

‘The Indian R&D is gearing up; however, investment in core innova on is s ll low’ …says Dr Panchapagesa Murali, Managing Director and CEO, Evolva India. He was also the Founder and Director of Dalmia Centre for R&D. He holds more than 20 years of experience in pharmaceu cal and healthcare R&D. He discusses the future of R&D in the Indian market. Jasleen Kaur Batra A er spending considerable me at Dalmia Centre, why the switch to Evolva? Switching to Evolva from Dalmia was never about the job or opportunities, it was purely on the basis of trying to understand science and the various options it offers. At Dalmia (one of India’s oldest and most

the step by step mechanism, for instance what goes behind making a compound, how it works, what is the reaction, how does that affect the result and more. One can only give answers to such questions in a drug discovery organisation. R&D enables one to not only find the answers to these questions but also prove their findings and make it more authentic and reliable.

The changes that the medical industry sees in the near future are going to be based on synthe c biology, and hence we need more people entering this venture.

distinguished business houses, which is into developing and launching natural products) we worked with natural products that were found in plants, we used whole cell plant cocktails and tried to launch a process where one may not even know what is the active molecule or the mechanism of the action; one could only show efficacy. In the present day scenario, people are inquisitive and want to know 36

Evolva is a company that deals with synthetic biology, which is a new area of biological research that combines science and engineering. It encompasses a variety of approaches, methodologies and disciplines. I wanted to be associated with an organisation where we could add credibility to our work by proving its mechanism and functionality. This was possible only at Evolva as we make the drug from

scratch and monitor its reaction, the outcome is a definite structure and has a long list of findings attached to it, making it reliable and authentic. This was purely the reason behind the shift. It was the next best thing to do, and change was the only way I could grow and explore the other options within R&D.

How has the journey with Evolva been so far? My tenure in Evolva began in 2006 as the CEO of Evolva India. The journey so far has been incredible. One really needs to keep in touch with technology or else he/she would have to chase it. Even after spending 25 years in this field, when it comes to evolving technology I believe I do not belong here. One has to try to be ahead of the curve. This was one of the reasons I joined Evolva, I wanted to learn about the technological advancements that have taken over the world and Evolva gave me the chance to not only learn and keep myself updated but also to apply that and see how it changes the outcome. Evolva has been a good experience as far learning is concerned. In 2009 Evolva experienced this transformation and got listed under the Switzerland stock exchange. It was a moment of pride to have achieved this goal and be a part of it during its undertaking. My experience with Evolva has been overwhelming, I have not only got the opportunity to be a part of the developing industry but have also been a part of the growth the company has made. Modern Pharmaceuticals I July 2011

In Dialogue Tell us about the Indian market for synthetic biology. I have worked with molecular biology from the very beginning of my career, but synthetic biology is the future. It is a new field and is just catching up in other parts of the world; we at India are on the right parallel track. The way semiconductor chips are the future of IT, synthetic biology is for science. The changes that the medical industry will see in the near future will be based on synthetic biology, and hence we need more people entering this venture.

What is the next step for Evolva? We have been doing fairly well; we are a company recognised globally and are associated with big names in the market. Our plan of action now is to expand our current capabilities and become an ingredient company. We want to make products, which are applied in pharmaceuticals, animal sciences as well as other places. The natural corollary is that now we are doing it at the R&D level and we would like to see if it can be scaled up to pilot level and also at levels where it can be made into products. The idea is to convert all the benefits of R&D into products. We are focussed on our ingredient nomenclature, and our focus will always remain on converting all our R&D benefits into products. Our future plans highly depend on the profile of our R&D pipeline. In the near future, we would also like to be one of the companies who has taken synthetic products from bench to bedside and would try to make these products available to all. This would be a cost-effective move.

How much investment is required to establish and run such an R&D facility? We have state-of-the-art R&D facilities all over the world. There are four R&D facilities; one each in Denmark, US, Switzerland and India. In R&D we have invested an approximate amount of $180 billion. The cost of instruments such as July 2011 I Modern Pharmaceuticals

A quick glance at Evolva... Is a leading pharmaceutical company into R&D for synthetic biology Focusses on pharmaceuticals, nutrition and consumer healthcare Is registered on the Switzerland stock exchange. With the head office in Switzerland and a unit in India- Chennai established in 2006 Follows a Business-to-Business model It has a state-of-the-art R&D facility Can accommodate 4-5 projects at a time Evolva India has 20 staff members out of which 17 are for R&D Won an award for the ‘Best Synthetic Biology Company of the Year 2011’ for the European sector by Frost & Sullivan fermentors, analytical equipment, detection devices, purification equipment, etc depends upon the size we go for. Hence, a lot of investment has to be made in terms of acquiring the new technology and maintaining it.

We would also like to be one of the companies who has taken synthe c products from bench to bedside and would try to make these products available to all. This would be a costeﬀec ve move.

Tell us about your product pipeline. Evolva is a biotech company focussed on the discovery and development of drugs based on its distinctive and proprietary genetic chemistry platform and is doing fairly well. We recently received the ‘Best Synthetic Biology Company of the Year 2011’ for the European sector by Frost & Sullivan. Keeping in mind the market trend and our reputation, we are working on Stevia, Vanelin and allied products, for flavours and fragrances, targets for crop protection and more. Each of these is with big companies such as Roche, Abunda Nutrition Inc. These big companies that we have tie ups with are pioneers in their field and they are ready to venture into synthetic

biology and the various products that it has to offer. Hence, our future plans would include extensive research to find better alternatives for the already existing agents. Stevia for instance is a sweetener and its demand is growing in India as it is the diabetic capital of the world. We need several products that will help control diabetes. Such innovations would be helpful in lifestyle management. This has a wide range and can go into juices, cakes, softdrinks and more.

What are the visible trends in the Indian R&D? The Indian R&D is gearing up; however, investment in core innovation is still low. This is largely due to the unavailability of venture funds in the country. The other bottleneck is the regulatory system, which impairs the progress of this industry. India has the potential to become a global leader; we have arrived at the scene and are one of the countries to be reckoned with. We should grab this opportunity and try to make the most of it by initiating modern ideas and thought process that can be capitalised for our benefits. We also need to understand the importance of R&D in India and should work towards opening more such facilities to make India independent and not seek a helping hand from other countries. Many companies have already come up and are doing some incredible work and are bringing a wave of change into the medical and healthcare industry. MPh (jasleen.batra@infomedia18.in)

Facility Visit

ACG Inspec on

OďŹ&#x20AC;ering tailor-made solu ons for Indian pharma As packaging lines in pharma gathers momentum, there is an increasing need for adequate quality check to maintain the standard of products. ACG Inspec on with its hi-tech systems aims to eliminate possible danger and loss. Chandreyee Bhaumik

ver the last four decades ACG Worldwide has been dedicated to providing end-to-end solutions for the pharma industry and fulfilling the requirements of over 1500 customers in more than 80 countries. It is one of the few companies globally that offers technology solutions for pharma manufacturing, packaging, security and R&D solutions, all under one roof. With globalisation and increased speed of packaging lines, there is a

major challenge for effective online checks to maintain product quality. Thus, ACG Worldwide addressed this requirement of the industry by establishing ACG Inspection in 2009. It is a company that aims to provide hi-tech camera systems to increase the possibilities of revenue and reputation. The group offers technology and expertise that has helped several Indian and multinational pharma companies fulfill their vision of producing quality products and providing solutions that are distinct and meet global standards.

Customer at the forefront Customer relationships have always been one of the topmost priorities of the Group and the same legacy has been passed over to ACG Inspection. The company boasts of a strong service team of highly trained vision system professionals with some of them having an experience spanning over 7 years in camera installation in the pharma industry. Further, inspired to offer quality services, the company also claims to comprehend the value of a satisfied customer and traverses all lengths to understand the root cause of

â&#x20AC;&#x2DC;Sanxx

Inspection systems at ACG Inspection

Modern Pharmaceuticals I July 2011

Facility Visit any issues at customer site and resolve it completely. Informs Harpal Singh, Director-Business Development, ACG Inspection Systems Pvt Ltd, “We offer quality-related services by manufacturing top quality high-speed cameras. We get the most accurate components based on the clients’ needs in terms of design. Today, we have 80 people working in this company.”

Craving and carving success In order to live up to the changing demands of the customers and stay ahead of competition in the field of operation, innovation along with customer satisfaction is the mantra for most companies. ACG Inspection is no exception. Elaborating on the relevancy of innovation, Singh avers, “We try to instill passion among our employees so that they are interested in performing more. With our aim to offer worldclass products and services, we have achieved top of line activities without compromising on the quality of our products.” Highlighting the quality standards, Singh continues, “For every work there is a type of internal review highlighting our achievements and goals. We have more than 700 systems that provide a plethora of end-to-end solutions. Also, what gives us an edge over other companies is that it is not just our sites that use these cameras but any manufacturing site can use these cameras.” Innovation being the mantra, the company has profusely invested in innovative R&D. Talking about the investment pattern of the company, Singh avers, “For us it is actually the investment of intellectual power. We are the youngest company in the entire Group.”

Figuring the need Pharma industry deals with life saving products. Thus, any minor mistake in the products will cause damage beyond comprehension. Elaborating on the necessity of the company’s inspections systems, Singh opines, “An example will clearly demonstrate the necessity. If a diabetic patient is July 2011 I Modern Pharmaceuticals

We oﬀer quality-related services by manufacturing top quality high-speed cameras. We get the most accurate components based on the clients’ needs in terms of design. Today, we are 80 people working in this company. Harpal Singh Director-Business Development, ACG Inspec on Systems Pvt Ltd

travelling and on the sixth day while opening the aluminum foil, instead of the sugar tablet finds a BP tablet, he is at a complete loss. To be true, there are enough chances of such mistakes to occur. They look the same, with a slight

difference in the shade of the colour. Thus, every product is inspected for such related features.” He continues with another example. Sometimes, the expiry date that is printed on the foil is not clear enough. If the last digit of

Tech help ACG Inspection provides a complete range of products that offers high end-toend solutions for the pharma industry. Blis-i Series This series of hi-resolution camera systems from ACG Inspection ensures that the blister product output meets all the quality specifications. The Blis-i series thus guarantees complete accuracy in physical product parameters in the production batch. The series comprises two product models, the Blis-I 14 & the Blis-1 V to meet specific production needs. Label-i Series A perfect product pack should have a perfect product label, with accurately printed batch code, component code, pharma code, bar code, data matrix code, etc. Further, it is also important that the label retains the aesthetic appeal of the pack by being perfectly aligned and accurately positioned. This series from the company uses advanced morphological characteristics to scan product labels on high speed packing lines to ensure correct monitoring of the above mentioned label parameters. Thus, this is an effective quality check on high speed blister packing and cartoning machines and on bottle & injectable filling lines. Micro-i Series This series can be seamlessly integrated with any capsule filler to ensure consistency in fill volume of powder, granules or pellets. Further, this also checks the number of tablets and micro-tablets being filled in every capsule. As the Micro-i integrate with the rejection and stoppage systems of the capsule filling machine, it adds value by ensuring quality of the capsule product output. Cart-i Series This system from the company scans the several stages of the carton packing process to ensure accuracy of product and content of the finished pack. In addition to maintaining product quality, the Cart-i can read and compare the bar codes and pharma codes on the pack insert, carton and blister to ensure zero mix-up in the high speed packaging process. Print-i Series This system ensures complete verification of printing with respect to characters, fonts, logos and colours. It can be integrated with the stoppage systems of printing machines in order to ensure minimal waste and accurate print output. 39

Facility Visit

The world may talk about high-end technology, however, prac cally, there are structural problems. We have to customise ourselves to the Indian manufacturing segment. Mukund Krishna Director- Technical, ACG Inspec on Systems Pvt Ltd

the expiry date 2014 is unclear, then there are ample chances of ambiguity and miscommunication. He says, “To be fair, with the production speed being so high there are chances of discrepancies. Thus, in this situation, we act as the last quality gate.”

Op mis c future At present, ACG Inspection caters to 13 countries including Pakistan, Bangladesh, South Africa, France, Jordan, Syria, US, Russia, Indonesia, etc. The company boasts that in holistic terms, there is no other company with similar services that cater to the entire spectrum. Singh says, “We are the only company in the country that encompasses everything from labelling to track and trace. We function from film inspection till track and trace following the footsteps of the Group (like capsule filling, tableting and packaging).” Singh adds that they are not into normal engineering, thus getting manpower is a bit difficult. He says, “It is a positive challenge. Since in our company, the scalability is so high augmenting success with adequate manpower is a difficulty. We are not into run-of-the-mill products, so it is also another type of challenge for us.” Supporting the above thought, Mukund Krishna, DirectorTechnical, ACG Inspection Systems Pvt Ltd, reiterates, “We compete with the international standards. The world may talk about high-end technology, however, practically, there are structural problems. We have to customise ourselves to the Indian manufacturing segment.” There are also other hindrances. Singh avers, “People do not give quality the due importance. We will have to embed ‘quality’ as the primary concern in the mindset of people. Authorities like the US Food and Drug Administration (US FDA), UK Medicines and Healthcare products Regulatory Agency (UK MHRA) are trying their best to better the situation. But as 80 per cent of the companies are into domestic manufacturing and do not export, such norms do not apply to them.” Discussing the future plan of the company, Singh signs off saying, “We plan to venture into the food and beverage industry as this is another vital element for living.” MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I July 2011

Industry Update

Unclogging supply chain in pharma

Need to enhance communica on A large part of the task of supply chain mangers and logis cs companies is to shoulder the responsibility of ensuring pa ent safety along with doctors. If the drug is not supplied at the right me and in right condi on then health of the pa ents will be aﬀected. The Supply Chain Management (SCM) companies need smooth func oning and certain roadblocks need to be overcome to achieve pa ent safety and sa sfac on. Indian pharma sector there are certain roadblocks that are hampering the smooth functioning of the supply chain and it is by overcoming these hurdles that SCM can look into providing better patient safety. Hence, utmost care has to be taken by pharma companies by implementing an effective supply chain. Slow technology integration, lack of communication or interaction between the pharma companies and distributors, infrastructural inadequacies, etc, are some of the constraints for this sector.

From start to end: The ﬂow

Titash Roy Choudhury

he Indian pharmaceutical market is expected to reach $20 billion by 2015, growing at a compound annual growth rate (CAGR) of 11.7 per cent during 2005–2015 and establish its presence among the world’s leading 10 markets, according to a report by Ernst & Young. “It is one of the fastest growing sectors in India currently,” states Prakash Rochlani, Vice President - Business Development, SSEA, DHL Supply Chain. But the most interesting part of this growth is that it is coming from various strata of the economy, especially from the rural sector. “Rural penetration of Indian pharma companies is one of the factors behind the growth of this sector,” feels

Krishna Parab, Director - Supply Chain, Sanofi India. And SCM plays a crucial role in supplementing this growth and supporting these changes in the pharma market. Along with supporting such changes as rural penetration and pushing the pharma sector for higher growth, SCM also ensures the availability and accessibility of the drug at the right place and on right time, thereby ensuring maintenance of the health of the patients and securing their wellbeing. The drug being manufactured at the manufacturing unit after sourcing of the raw materials has to be transported and produced to the end customer at the right time, in right quantity and the best quality. A slack in any of these processes may affect the health of the patient - the end users. Currently, in the

The supply chain begins with sourcing of raw materials and transferring them to the manufacturing units. Once the product is manufactured and packaged, it is transferred to the central hub from where it is moved to the mother warehouse. Finally, from the mother warehouse the products are sent to Carrying and Forwarding (CNF) agents. “Sanofi has its mother warehouse at Mumbai since most of its manufacturing units are around this city. All major pharma companies have a mother warehouse where all the products are stored before outsourcing them to CNF agents,” informs Parab. The CNF agents then store the finished goods on behalf of the company and receives orders from the distributors or stockist corresponding to which they deliver the goods to the distributors. Pharma companies usually outsource this activity to companies like Safe Express or DHL and these companies look into the distribution of the drug to the distributor. But the Modern Pharmaceuticals I July 2011

Industry Update problem starts after the pharmaceuticals reach the distributors where there is a major communication gap.

Ensuring pa ent safety Patient safety can be ensured by ensuring product integrity. “Patient safety is traceable to all key activities in the supply chain, sourcing, procurement, manufacturing and distribution,” comments S Sridharan, Managing Director, TAKE Solutions. Ensuring patient safety is one of the indirect responsibilities of supply chain in the pharma sector since the health of a patient is directly related not only to the availability of the drugs but also to the drug being present in the required quantity and correct condition. The best way to be prepared for any kind of medical emergency is by having an efficient supply chain that would make the drug available in the market in no time and with proper care. The unavailability of any drug, which we face sometimes, may lead to dangerous and cumbersome situations for the patients. And to take care of such an imperative responsibility, the supply chain managers in the pharma sector have to keep certain factors in mind that would help them execute their responsibility of delivering the drugs smoothly. Time is a crucial factor and special attention has to be provided to it. Even after proper technological advancement, if the product fails to reach the destination on time it loses its efficacy. “At Sanofi, whenever we send cold chain products, we always transfer it by air to minimise the time required. If our products do not reach the destination on time we destroy the products,” informs Parab. Healthcare is a sensitive sector and special attention should be given to each process as it can directly affect the patients. Also when we talk about healthcare, we also take into account the delivery of drugs or medicines to the patients since without it the process of recovery will not begin. To ensure that the drugs are reaching the end consumers it is the supply chain companies that come into play. They form an integral part of the healthcare industry, which will cease to perform if the medical July 2011 I Modern Pharmaceuticals

There are many price regula ons that are being implemented but we think more regula ons are required to improve the quality aspect of the supply chain. The process at present is rigid. Prakash Rochlani Vice President - Business Development, SSEA, DHL Supply Chain

products are not properly transported from the manufacturing unit to the patients. And to achieve that, keeping a huge inventory is the only option. “For any industry, maintaining adequate inventory is must, but when it comes to healthcare inventory management becomes extra crucial and hyper critical,” explains Rajkiran Kanagala, Head Business Development, TCI Supply Chain Solutions. Like if there is an emergency of any particular drug, the company should be ready with back-up drugs and should maintain a proper inventory. “But the Indian pharmaceutical supply chain is unorganised and fragmented resulting in bad inventory planning. There is never 100 per cent inventory planning, instead most of the Indian companies keep buffer stock, which at the end of the year has to be destroyed, causing both environmental and monetary damage,” sighs Rochlani. So proper inventory management has to be achieved for providing product integrity, and thus ensuring patient safety. Proper processes also need to be implemented for maintaining the conditions under which the drugs are stored and transported. Storage and transportation of drugs is an extremely sensitive aspect of pharmaceutical supply chain. Different drugs have

different storage requirements that have to be looked into by the supply chain department. Like cold chain drugs require a certain temperature at which it should be stored and also transported so that the quality of the drug is not altered. “While all other activities now conform to pharmaceutical good practice guidelines, the element of warehousing, transportation and distribution is perhaps one of the ‘weak links’ in the supply chain. Successful companies therefore employ qualified logistics service providers and closely monitor these activities through use of IT,” comments Sridharan.

The gap in the chain This flow of pharmaceuticals from the source to the end user needs to be uninterrupted and cohesive, but in India with a highly fragmented and unorganised distribution system, maintenance of a proper flow is hindered. There are almost six lakh companies under this domain and maintaining a proper organised retailing in such a fragmented situation is not possible. And to make the situation worse, the drug manufacturing companies have no direct control on the distribution of the drug from the distributors to the retailers or pharmacists. “We do not have any direct control on the distribution of

Ensuring that the goods reach on me is essen al but considering the condi on of roads, the present scenario is grim. There are many transit points that lengthens the total me taken making the process cumbersome. Krishna Parab Director - Supply Chain, Sanoﬁ India

Industry Update

While all other ac vi es conform to pharmaceu cal good prac ce guidelines, the element of warehousing, transporta on and distribu on is perhaps one of the ‘weak links’ in the supply chain. S Sridharan Managing Director, TAKE Solu ons

the drugs once it reaches the distributors. But indirectly few pharma companies are trying to make the distribution system better. Like Sanofi is training the distributors in proper handling of the drugs and looking into their proper transportation,” says Parab. For MNCs like Sanofi or other companies such indirect control can be one of the options but for small generic drug making companies in India such options are not viable. They do not have the money to invest in such training and so have no option but to leave the distribution in the hands of the distributors. Although there is an act under the Indian Constitution, Drugs and Cosmetics Act, 1940, which has underlined the rules and regulations that each retailer and distributor has to follow, in such a highly fragmented industry there is hardly any monitoring done to check if they are adhered to. In such a situation, direct control on the distribution of their product from the distributor to the pharmacists or retailers by the pharma or logistics company will bring more transparency as it will ensure that their drugs reached the doctors or retailers at the right time, quantity and condition making the Indian pharma sector more efficient and reap more benefits. To achieve this, first, the distribution system in relation to pharmaceuticals needs should be organised and brought under a proper domain, and then rules should be developed that gives pharma companies the authority to regulate the distribution pattern of their drugs till it reaches the retailers. “The distribution pattern is unorganised and fragmented and there is no proper visibility. Even the trading community needs to be 44

aligned which will help in adding value to the supply chain in pharma sector,” adds Parab. “This has been a major hurdle for years and government intervention may help to solve this problem. If there are regulations put down by the government then this gap can be bridged in a systematic manner and will prove beneficial for both the pharma companies as well the logistics

Direct control on the distribu on of their product from the distributor to the pharmacists or retailers by the pharma or logis cs company will bring more transparency.

companies,” opines Kanagala. Once this glaring gap is shortened the supply chain will become more effective, its functioning will improve as communication between the producers and the distributors will be improved and this will at the end ensure that the right drug has reached the right person in the right quantity and quality. It is only when the government will use an upper hand on this problem that we will see drugs being delivered on time and in required quantity, which subsequently will reach the patients in right dosage and right condition, ensuring their good health and avoiding any health risks.

Role of technology To ensure proper supply of the products on

time and in proper condition technology and communication are two factors a pharma company has to look into. As for communication, all the stakeholders in the supply chain are in touch with each other. “There is proper communication happening in India in context of the supply chain of the pharmaceutical sector,” avers Parab. But one part that needs more attention and changes is the technology side. “When compared to other sectors in India, pharmaceuticals look the most primitive and as for supply chain management India is still relying on traditional models,” informs Rochlani Indian pharma companies still rely on Enterprise Resource Planning (ERPs) and old software. And it is in this aspect that the supply chain in Indian pharma is lagging behind when compared with its international counterparts. When we look at countries like the US, Europe and their processes, we see a proper amalgamation of the latest technology, which increases the efficiency and makes the process more transparent. But in India, and especially in the pharmaceutical sector technology, penetration has not been deep enough. With several vendors in the game and mostly unorganised, proper technology is required for tacking the position of the drug. Most of the drug companies in India still do not have fully integrated upgraded software such as Track and Trace system or Radio Frequency Identification (RFID) to monitor the total visibility of the position of the product. Usage of RFID will be limited in India considering its high price tag, but as for track and trace system Rochlani predicts, “Looking at the kind of growth this sector is registering, this technology will be adopted in the next 12 to 24 months”. DHL is importing technology from Australia. It is using a technology where the entire process of tracking the drug can be done from the manufacturing stage to supplying it to the distributors till it reaches the pharmacists or retailers. Thus, DHL is taking steps to bridge the communication gap between the manufacturing or production side and the distribution side. And more such steps need to be taken if the scenario needs to improve. Modern Pharmaceuticals I July 2011

Industry Update

For any industry maintaining adequate inventory is must, but when it comes to healthcare industry inventory management becomes extra crucial and hyper cri cal. Rajkiran Kanagala

Head - Business Development, TCI Supply Chain Solutions “Manufacturers, logistic service providers and regulatory bodies will have to drive the adoption of better technologies in pharma sector. Indian pharmaceutical sector is still slow while responding to new changes be it technological or otherwise and is highly reliant on traditional models,” avers Kanagala. Logistics companies like transport providers have started using Global Positioning Systems (GPS), but when compared with the technology used worldwide in SCM in the pharma sector, India has a long way to go.

Infrastructural limita ons to overcome Inadequacy of infrastructure is another hurdle to the proper functioning of the supply chain in pharma. Proper infrastructure is essential for the proper transportation and storage of the drugs, and if the standards are not maintained then it will affect the supply chain and in turn affect the patient’s need for the medicines and other medical products. “Ensuring that the goods reach on time is essential when it comes to pharmaceuticals but considering the condition of roads in India, the present scenario is grim. There are too many transit points that lengthens the total time taken making the process cumbersome,” avers Parab. Yet significant progress is happening on that front and government is taking initiative to better the present conditions. But it is the infrastructure of the warehouses that requires immediate attention. “When we talk about the infrastructure of the warehouses then almost 9 out of 10 warehouses will not qualify outside India as a pharma regulated centre,” states Rochlani. According to Kanagala, the 46

reason behind the sub-standard condition of the warehouses in this sector is lack of awareness, “The pharmaceutical sector should see what is happening in the other verticals and how they are benefitting. This sector needs to be more open-minded and adopt the best practices in the industry.” Warehouse is where a drug stays for the maximum period of time like two to three weeks. And it is at this place that more development is required. “The top growing sector in India under DHL is the pharma sector and to maintain this growth trajectory the current infrastructure of the warehouses needs to be improved. DHL is trying to change this scenario by developing

rate. So inter-state sale is not permitted, and with the introduction of the Goods and Services Tax (GST) this scenario may change. This law will encompass all the taxes be it excise duty, VAT, sales tax and integrate them into one single tax. “This will increase the transparency of the processes and will also permit inter-state sales,” comments Parab. The Government of India should also introduce bar coding system for further efficiency and precision. “There are many price regulations that are being implemented but we think more regulations are required to improve the quality aspect of the supply chain. The process at present is rigid, for example, I can increase my distributors list to any number but when it comes to reducing my distributors list it gets complicated,” avers Rochlani. And if the following recommendations are adhered to then it will lead to lesser hurdles in the process amounting to better flow of the drugs. Be it price regulations or the taxes, the supply chain needs to be made flexible and well-connected and by bringing forth the changes suggested the connectivity can be improved.

Quick Picks Proper infrastructure is essential for the proper transportation and storage of the drugs, and if the standards are not maintained then it will affect the supply chain and in turn affect the patient’s need for the medicines and other medical products. distribution points all over the country and building proper warehouses for proper storage of drugs,” informs Rochlani.

The legal aspect The pharma industry has Acts like the Drugs and Cosmetics Act, Drug Price Control Order, to control the drug prices and make it available to the masses. Also, the government tries to keep a check on the agents so that they pay the required taxes. However, the situation that is hampering the supply chain of pharma sector is the fact that in India each state has a different Value Added Tax (VAT)

Future prospects DHL has registered 40 to 50 per cent growth year on year in the supply chain department of the pharma sector. “And we believe that this double-digit growth will continue for the next two to three years since Indian pharmaceutical sector has phenomenal potential,” predicts Rochlani. More investments and competitors are required in this section for registering even better growth. “The least acceptance of the best practices takes place in the pharmaceutical sector and this attitude needs to be changed,” believes Kanagala. Positive changes need to be brought about from the government’s end and the industry side and new developments have to be incorporated. Patient safety is the end goal for all the stakeholders involved in the SCM of pharmaceuticals and to achieve this, the sector needs to be transparent, better organised and open to changes. MPh (titash.choudhury@infomedia18.in)

Modern Pharmaceuticals I July 2011

Interface

‘Pressure to enforce more an -counterfei ng features in products, non-tariﬀ barriers and quality standards will force the industry to increase prices’ …says Angelos Orfanos, President, Life Sciences and Healthcare, DHL and Global Customer Solu ons (GCS). A member of the GCS Global Senior Management Team leading the DHL Life Science Steering Commi ee, he discusses the importance of warehousing management in the pharma supply chain in light with the one that DHL has. Chandreyee Bhaumik What is your business mantra?

How have you customised your oﬀerings for the life sciences space?

We have undertaken a lot of commercial responsibilities. We take care of warehousing, express and freight that are considered to be the pillars of logistics. Thus, we offer customised solutions for logistics along with the

DHL globally partners with the top 20 leading pharma companies. An investment in a 7,000 sq. ft. facility at the Free Trade Zone (FTZ) in Chennai with plans to add more facilities across India

We have mul -use warehouses in Mexico, Brazil, the US and many other countries. In these warehouses, not only pharma companies can avail opportuni es but also other segments can leverage on it.

required training and best access. We have always been following the ‘Strategy 2015’ that encompasses our approach in its entirety. Further, for the last few years since the pharma industry has shown stable growth, we have been inclined to make considerable investment in this sector. We hope that this will help us in accelerating the success of both the industry and company. 48

All sites will be certified with our global internal standards and local certifications that are required by state/country DHL has a unique end-to-end offering across business units and will continue to provide customers with the possibility to manage their entire logistics and supply chain for life sciences products with a broad

footprint and standardised processes across the region.

Warehouse is an essen al component of an eﬃcient supply chain. How important is it to provide an op mal warehousing facility? DHL takes pride in bringing forth the Good Manufacturing Practices (GMP) certified pharma warehouses. This is indeed the brainchild of true innovation. We have multi-use warehouses in Mexico, Brazil, the US and many other countries. In these warehouses, not only pharma companies can avail opportunities but also other segments can leverage on it. It makes the entire process much cost-effective. While discussing warehouse in the pharma logistics, it is essential to discuss the temperature controlling aspect of the said facility. To be precise, while dealing with clinical trials and stem cell research ingredients, pharma warehouses serve fruitful purpose. There are also customer service centres that monitor the logistics pattern of the supply chain from the beginning to the end. To cite an example, in Europe, there is a dedicated tracking system, cold chain transport solutions. Nowadays, customers want more visibility and transparency. This is applicable more in case of clinical trial materials. Thus, warehouse management system is important. Further, it can be said that tracking and tracing is a vital component, and here the relevance of Modern Pharmaceuticals I July 2011

Interface 2D bar coding comes into picture. Further, global organisations are also into organising IT platforms that try to take care of most of the problems.

How important are regula ons in this market? Temperature variation between different countries makes the relevance of the regulations all the more mandatory. If a product is suitable for 45°C and then it has to go to the Middle East, then it is very essential to maintain the temperature regulations. In Brazil, labels are mandated. Thus, certain processes and various laws have to be kept in mind in this context. However, it is also necessary to remember that the laws vary according to the products.

What are your plans in India? How will it aﬀect the bo om line of your business? In India, we conduct business with both Small and Medium Enterprises (SMEs) and big pharma. As far as the latter is concerned, we mostly deal with all MNCs. Life sciences and healthcare is one of DHL’s top sector priorities for the region. With the exponential rise of the pharma industry in India, there has been a parallel demand for cold chain logistics to move large volumes of pharmaceuticals from the manufacturing site to the end users. DHL is one of the major innovators in handling pharmaceutical, chemical and cold chain high value products. DHL’s Life Science Competence Centres across India provide support to our customers globally, thus minimising time and cost risks. This approach allows us to enhance our value proposition and provide true end-to-end solutions leveraging our local, regional and global network.

What are your predic ons for the life sciences ver cal? Given the current economic landscape we have seen both an upswing as well as a downturn within the life sciences and healthcare sector. Increasingly, big pharma companies are looking for solutions to deal with under utilised networks, particularly as the patent cliff nears. The industry is likely to maintain a growth rate of 15-20 per cent annually in the coming decade, according to various reports. In the next decade, India’s spend on healthcare will grow from the current 1 per cent of the Gross Domestic Product (GDP) and new patented drugs will be available in India much faster. Further, drugs will reach a large segment of the rural population. The growth of India and China, and the huge population in these two countries lure the who’s who of the global pharma industry to these two countries. MNCs have a share of only 15 per cent of the domestic market and this is expected to grow to 25 per cent in the coming four to five years. Pressure to enforce more anti-counterfeiting features in products, non-tariff barriers and quality standards will force the industry to increase prices. MPh (chandreyee.bhaumik@infomedia18.in)

July 2011 I Modern Pharmaceuticals

Market Trends

Chandreyee Bhaumik

Recrui ng and retaining the right talent has always been a task for the Human Resource (HR) departments of most industrial sectors. For pharma HR, the task at hand may require revisi ng some of their exis ng policies and strategies, thus ensuring nothing but the best. 50

Modern Pharmaceuticals I July 2011

Market Trends

o sooner does one step into higher secondary school, he/she is bogged by ‘What you want to become in life?’ questions! At that tender age, for any young student, attractive professions still remain in the lines of medicine, engineering and architecture. Pharma as a profession has not achieved the deserving glamour, and most often it is the secondary choice. However, with the increasing number of pharma colleges, the future of these graduates seems brighter than before. Is the field stable enough to sustain the increasing attraction? Is the pay lucrative enough to tediously work in a lab for long hours? Are the HR departments able to pick the right candidate for the right job under the given circumstances? We try to decipher the value of this field as a career, and why it should be pursued further.

The pharma treasury McKinsey’s report, ‘India Pharma 2015: Unlocking the potential of the Indian Pharmaceuticals Market’ predicts that the Indian pharma industry will treble in the next decade, and catapult the country into the top 10 markets of the world by 2015, overtaking Mexico, Turkey and South Korea. Thus, in order to keep up with the extensive industry growth, HR departments of pharma companies are required to arrange for extensive recruitment procedures. Dr Ajit Dangi, President & Chief Executive Officer, Danssen Consulting, avers, “The pharma industry in India has made phenomenal progress in the past few years. In spite of intense competition and price controls, pharma companies have successfully retained their sales growth and profitability over the years making it an attractive sector for career opportunities.” He adds that with over $23 billion in domestic sales and exports combined in 2010, both growing at double digit, pharma in India has made a mark in the global scenario. However, being a knowledge-based industry, one of the key challenges that the industry is going to face is July 2011 I Modern Pharmaceuticals

In spite of having over thousand pharmacy colleges in the country and equal number in management colleges, recruitment for pharma companies con nues to be a challenging task. Dr Ajit Dangi President & Chief Execu ve Oﬃcer, Danssen Consul ng

acquisition and retention of talent. He clarifies, “Human resource management therefore has to develop innovative strategies to face this challenge.” Talking about whether pharma is the profession to look for, Dr Ajaykumar Sharma, Industry Analyst - Pharma and Biotech, India, Frost & Sullivan, comments, “Pharma is not always rewarding as far as monetary gains are concerned. But it is obviously one of the most stable industries to work in.” For anyone taking pharma as career, the question to analyse is; ‘Is pharma

However, being a knowledgebased industry, one of the key challenges that the industry is going to face is acquisi on and reten on of talent.

lucrative enough?’ Citing the growth of the pharma industry and the need to catch up with this growth, K G Umesh, Head, Human Resources, The Himalaya Drug Company, reiterates, “India’s pharma industry is now the third largest in the world in terms of volume, expecting to reach an estimated $55 billion by 2020. With the highest number of US Food and Drug Administration (US FDA) - approved plants outside the US, the Indian pharma industry is poised for a steady growth. We have wide ranging capabilities in the field of research, drug

manufacturing and technology resulting in effective, affordable drugs of highest quality. So currently, pharma is definitely a lucrative market to be in.”

HR gearing up enough? No matter what type of industry, it is essential to hire the best and brightest candidate for every position. HR department of an organisation focusses on recruitment, management and providing direction to the people who work in the organisation. It deals with issues related to people such as compensation, hiring, performance management, organisation development, safety, wellness, benefits, employee motivation, communication, administration and training. Thus, in order to facilitate the growth of a company, HR departments need to gear up. As Dr Dangi opines, “HR policies, as a first step should therefore be revisited, to make working in pharma an attractive career choice vis-à-vis other sectors. In spite of having over thousand pharmacy colleges in the country and equal number of management colleges, recruitment for pharma companies continues to be a challenging task. It is estimated that less than one third of the graduates coming out of such institutes are ‘employment ready’ and have to be retrained.” Thus, training and development form the fundamental aspect of HR policies for optimising the return on employee. Seconding this thought, Dr Sharma shares, “If one considers the trends in the pharma industry, then one is sure to notice that there has not been any drastic changes in the industry. The industry involves well-knitted 51

Market Trends

Internships are perfect analy cal tools for deciding whether it is the right choice for the candidate or not. Thus, big companies such as Pﬁzer, Zydus Cadila, etc should e up with educa onal ins tutes. Dr Ajaykumar Sharma Industry Analyst - Pharma and Biotech, India, Frost & Sullivan

processes. For pharma industry there are neither advertisements in papers nor too many walk-in interviews. It is only for the medical representatives that there are walk-in interviews.” While other industries are already on Internet portals, HR of pharma companies need to invest in such affairs.

The dough’s worth Pay packages are not the be-all and the end-all of any business. But it is indeed the remuneration that provides one the due credit for the work performed. A slight increase or a decrease in the pay package makes one wonder whether it is the right profession that he/she is into. Umesh clarifies, “We try to ensure that competitive packages are offered; the best in the industry. Our employees are our assets and safeguarding their interests is of primary importance to us.” Pay package of any pharma

company is extremely vulnerable. Dr Sharma clarifies, “Usually the CEO of a pharma company gets `60 lakh per annum. However, the fringe benefits make the profession all the more exciting and lucrative. As gross income, the salary of the CEO of a multinational company may shoot upto `6 crore per annum. But, it is not the salary of the CEO of a company that would actually determine how lucrative the industry is. A fresher in pharma can expect to earn ` 3-6 lakh per year, depending on the qualification and the talent.” Dr Dangi shares a different opinion. He states, “It is a mistaken belief that a prospective employee is always looking towards a big jump in compensation while considering jobs. While good compensation is important, factors such as well planned career path, a learning environment and company’s reputation, etc, play an important role

Incremental growth (2005-2015)

$ billion

By absolute growth, India will be among the top 5 markets globally during 2005 to 2015 US 196 China 23 India

France

Japan

14 13

Canada

Brazil Germany

in attracting good professionals. Today’s young professionals are not very keen on terminal benefits like superannuation, provident fund, gratuity, etc.” Thus, he says that innovative compensation management that is performance based and competitive not only with pharma industry but also other sectors is important. He adds, “It is not uncommon to see sales and marketing professionals in pharma companies switching to other sectors like banking, aviation, automobile, hospitality, real estate, etc, for a significant salary hike. Most pharma companies have structured approach to compensation management. However, employees with high potential should be put on a fast track by giving challenging assignments and opportunity for job rotation in different departments. Employee stock option is another component to retain good talent.”

The key to right recruitment The focus of HR department of any company is to hire the right talent that is a perfect blend of drive, determination and ambition. Emphasising on the HR activities as far as recruitment is concerned, Umesh clarifies, “We try to shortlist candidates with adequate industry knowledge and more importantly who are willing to learn. We believe that these are the two most important factors that one should have while applying for any position. HR needs to ensure that the right person is recruited for the right role, every time, which results in a long term association with the company.” Continuing with the recruiting plans and procedures, Umesh adds, “It is vital for any HR department to create a company culture that draws in the brightest minds in the industry. Creating flexible employee friendly policies and an open, honest and approachable atmosphere is also important for any HR department.” Further, it is essential to select the right individual for the right job purely based on merit. HR should ensure that employees at all levels are fully engaged and that policies are in place to drive this initiative. Umesh further adds,

Source: IMS World Review; analyst projections; McKinsey India Pharmaceutical Demand Model

Modern Pharmaceuticals I July 2011

Market Trends “Employees should receive international and cross-functional exposure, which will give them opportunity to grow. Development programmes are also extremely required. Last, but not the least, employees should be offered bestin-industry salary.” Dr Sharma believes that the HR policies of pharma companies needs to traverse a long way. He cites a few examples to illustrate the above fact. He says, “Companies like Hindustan Lever have designed their own template that assesses whether the candidate is eligible or is the right person for the company. Such evaluation eases the process of recruiting also.” He adds that there are some companies who are conducting psychological tests that help in the recruitment process. He opines, “I have never seen any such tests conducted by any pharma companies. Pharma companies should learn about conducting such psychometric tests.”

Strengthening the founda on There are constant talks about the inclusion of practical, hands on training in pharma colleges. This will help in giving the students a flavour of the work culture that they would be stepping into. Commenting on the necessity of the practical training, Dr Sharma avers, “Several institutions like ICICI Bank have taken an initiative in introducing special courses in MBA colleges. This gives an idea to the students what they can expect in their new job. Similar efforts should be undertaken by pharma companies. This will smoothen the process.” Pharma colleges should concentrate on making students employable, apart from imparting quality education. Umesh says, “Introducing specialisation in the B Pharm course, such as drug discovery, clinical research, quality assurance and regulatory affairs, will contribute towards making students ready to face the continuously expanding and challenging industry like this.” Further, there should be internship programmes conducted by pharma companies. Dr Sharma opines, “Internships are perfect analytical July 2011 I Modern Pharmaceuticals

Introducing specialisa on in the B Pharm course, such as drug discovery, clinical research, quality assurance and regulatory aﬀairs, will contribute towards making students ready to face the con nuously expanding and challenging pharma industry. K G Umesh Head - Human Resources, The Himalaya Drug Company

tools for deciding whether it is the right choice for the candidate or not. Thus, big companies such as Pfizer, Zydus Cadila, etc should tie up with educational institutes.”

Prevent brain drain Selecting the right candidate and more importantly retaining the talent is an over imposing challenge for a pharma company. Dr Sharma says, “Mass attrition is a common occurrence especially at

Employees with high poten al should be put on a fast track by giving challenging assignments and opportunity for job rota on in diﬀerent departments.

the mid-senior levels of MNCs. A visible shift is seen from multinational to the generics.” However, he considers this aspect as a positive challenge as people are ready to work for generics now. Further, with most pharma companies making strong global footprints, HR departments have to cast its net wide. Dr Dangi opines, “It is estimated that over 15 per cent of scientific and technical personnel working in pharma industry in countries like the US are of Indian origin and are aspiring to come back as the economy in the West is slowing down.” He advocates that to attract such talent with a skill set of the future, a separate strategy is required that is

different from the normal method of recruitment. This will involve relocation assistance such as accommodation, relocation expenses, help with children’s education, cultural counselling, etc. He adds, “Significant numbers of today’s science and management graduates are women. Thus, HR policies therefore have to make conscious efforts to promote gender equality in the organisation. Unfortunately barring a few exceptions, one finds few ladies in the board room of pharma companies. We have to learn from sectors like banking, Fast Moving Consumer Goods (FMCG), etc that have produced some outstanding lady CEOs.” Pharma companies are trying their best to cope up with the existing demands. Umesh says, “One of the biggest concerns of any industry is the escalating costs, given the rising inflation rates in the global market. Therefore, it is a challenge to offer competitive salary packages in this environment. At Himalaya, we do a detailed market survey on the pay packages offered by FMCG and pharma companies and then revise the rates to best suit our employees’ requirements.” Indeed the time has come for several visits and revisits to the already existing HR policies. Are the recruitment processes at par with the industry needs or there is a need to rehash the predicament? The HR departments help the companies select the best, and then provide these employees with the best. There is nothing that can bring more gain to any company than a satisfied employee, and the HR department can ensure this satisfaction. MPh (chandreyee.bhaumik@infomedia18.in)

Marketing

Drug marke ng

Building a symbio c rela onship between the doctor and MR With the existence of a plethora of pharma companies, good marke ng of a brand is extremely essen al in today’s world. Diﬀerent prac oners view medical representa ves (MRs) diﬀerently. If MRs can work in co-ordina on with doctors, a smart way to boost product sale is on the scene. Getting an already prescribing doctor to further increase his prescription rate is sometimes possible. However, this is easier said than done. Yet there would be many greenhorn doctors who may not be capable of giving any concrete support to their brands. Many newcomer-physicians face an uphill task and unless they themselves have a ‘solid’ base of patients, they cannot help the MR to achieve his targets. What are the options available to the MR then?

Medical camps

rrespective of the nature of their business, the sales and marketing team of any industry has a threepoint agenda: generate business, outdo last year’s sales and beat the annual targets. The entire team right from the field sales officer to the manager and the chief of marketing and sales meet periodically and review their quarterly performance. In the pharma industry,

Dr Rajan T D Pharma Consultant & Practising Dermatologist

the financial year beginning in April each year is also the time when the MR and the area manager go full throttle to boost their sales. For the drug industry, the first quarter is extremely crucial for survival. The first quarter of Indian financial year coincides with the beginning of monsoon. It is the season when infectious diseases flourish and general practitioners’ clinics across the country are teeming with patients. The number of referrals from these clinics to specialty consultants is also at its peak during the rainy season. With this knowledge the top pharma management pressurises its peripheral team to achieve at least 50 per cent of their annual target in these three months. Consequently, the MR cajoles his friendly physicians to step up prescriptions of specific brands.

The most common approach adopted by pharma companies is to conduct medical camps in doctors’ clinics. The company distributes handbills and provides sufficient samples to the physician. On the appointed day, the MR and his manager help to organise the flow of patients and ascertain that the doctor dutifully recommends their brands. This technique achieves two objectives: the new physician gets exposure in the community and the brands in question are well registered in the doctor’s mind. As the patient returns for follow-up, the physician would observe the efficacy of the dispensed drugs and consequently, would permanently consign it to memory. If the camp is successful in drawing huge crowds, the physician and the company plan further camps at quarterly or half-yearly intervals. Medical camps are now becoming less popular in urban areas as the general public has started viewing them with suspicion. Modern Pharmaceuticals I July 2011

Marketing The other drawback of this technique is that it is effective only in the lower socioeconomic areas of society and therefore cannot be replicated in posh localities.

Dual approach It takes no rocket scientist to understand that the number of prescriptions generated will be directly proportional to the number of busy doctors who support some brands. Furthermore, the number of patients who consult a physician will actually determine the quantum of medicines prescribed by him. The MR can either get a full quota of prescriptions from a smart mix of meeting busy doctors as well as building up a repertoire of supporting doctors for the future. This task may seem daunting to a novice field sales officer or a laidback manager. A careful analysis of any physician’s clinical graph will indicate how to classify the method of marketing and rapportbuilding with different categories of doctors. The busy doctor should be cautiously tackled to build up current targets, whereas the beginner should be periodically assessed and ‘groomed’ to meet tomorrow’s sales targets. Depending on his attitude and personality, a busy physician may view the MR and his team either as an intrusion into his work time or as a welcome break for a light moment. Newly qualified doctors, consultants and general physicians, view the MR and his manager differently. Some of them look up to him as a provider of medical updates or ‘goodies.’ Others find him to be a source of general information and a means of passing free time. It is important for the marketing team to remember that both, the busy physicians as well as the ‘fly-swatting’ neophytes are of great significance to the drug maker. One could be termed as ‘present’ currency whereas the latter could be a future goldmine!

Anxious start When a new general practitioner or specialist begins his practice, there are several apprehensions in his mind. This is particularly so if the physician in July 2011 I Modern Pharmaceuticals

question is a first-time doctor from his family. Questions like: Who are the other busy compatriots practicing in nearby areas? How should he position himself in the community? What should be the level of charges to be collected from his patients? Should he do some risky procedures in the clinic itself? Should he focus on some sub-specialty of his practice like the competitors? Physicians usually do not get answers to these questions easily. Although senior colleagues and friends provide friendly advice based on their experience, the young physician will realise that the correct answers are available only after he actually takes his seat.

Worth noticing A beginner would want to know what such ‘specialty’ other physicians in the vicinity pick on. This knowledge would allow him to identify his niche and build up the practice. Senior MRs could provide data on such matters and guide the doctor. The goodwill earned from such information would be immense. Since senior MRs from the area know the number of doctors, their type of practice, their patient profile, patient’s socio-economic level etc, he can fill in such information easily. A smart MR could provide a list of physicians with their qualifications. Consultants can also be provided the list of local general practitioners in the area. This makes it easy for the specialist to introduce himself to them and expect referral of patients. MRs are privy to information about the procedures carried out in the clinic and charges levied by local physicians. For a newcomer this data helps him to fix the benchmark for clinic timing, charges, value-added services, etc. Freshly practicing consultants in a new polyclinic may be unaware of the nearest chemist shops, pathology laboratory or X-ray centre. MRs could update such tidbits to the doctor, which helps him to guide his patients better.

Pa ern of prac ce Physicians, in the early years of practice, are curious to learn about the pattern of practice of their compatriots. General practitioners with some experience of paediatrics tend to focus on children’s health in their clinic, whereas some others would concentrate on women’s disorders or skin diseases. A beginner would want to know what such ‘specialty’ other physicians in the vicinity pick on. This knowledge would allow him to identify his niche and build up the practice. Senior MRs could provide data on such matters and guide the doctor. The goodwill earned from such information would be immense. In the case of dermatology, for example, there is a shift in the nature of their practice. Two decades ago a fresh postgraduate doctor would set up a simple clinic with a torch and magnifying glass as equipment! Today, the repertoire of a dermatologist is incomplete without some exposure to cosmetology. In most metropolitan cities, the average skin specialist is no longer visible; as they are overshadowed by glitzy, extravagant cosmetic clinics and laser surgery spas! Yet, considering the prevalence of skin disorders everywhere, there is definite scope for a committed expert to conduct dermatologic practice and build up a strong edifice. Pharmaceutical managers can map out areas such as these and advise fresh MBBS+DVD practitioners (who are not MD qualified) to use the ‘dermatology’ route to build up their practice.

Teach him to ﬁsh! Drug marketing has moved far away from the traditional forms of reminding the doctor of specific brands. Helping the physician to build up his practice is a sure cure for both the doctor and the pharma company. The old Chinese adage: ‘Give a man a fish and you feed him for a day. Teach him to fish and you feed him for a lifetime!’ can be adapted to the pharma industry too. Build up the doctor’s practice and his soaring prescriptions will feed the drug maker for many, many years to come! MPh (rajan.td@gmail.com)

Clinical Research

Outsourcing knowledge-based skills

Medical wri ng on the radar Medical wri ng primarily involves wri ng on topics for the medical fraternity as well the common man. As the healthcare market is growing, demand for healthcare informa on is also increasing. Outsourcing is on a growing curve, since India has a pool of qualiďŹ ed and experienced professionals. A look at the fast-growing discipline.

scalating cost of drug development, exhausting pipeline of effective molecules, expiry of patents, fierce competition from generics and the economic recession have put a lot of pressure on the global pharma industry for cost containment and maintaining profitability. The recent German legislation to control healthcare costs that proposes linking the prices of drugs with their efficacy may further add to worry of pharmaceutical companies and

force them to strictly control the R&D costs. To manage these challenges many companies are trying to reduce their overhead costs by focussing on their core R&D strengths and entering into strategic partnerships with Contract Research Organisations (CROs) for the non-core functional areas to utilise the CROâ&#x20AC;&#x2122;s expertise. For long term gains, companies are shifting their focus from individual project outsourcing models to the strategic Full Time Equivalent (FTE)/Functional Service Provider (FSP) partnership models, as these partnerships offer flexible models to handle diverse trials.

Models adopted Dr Rajesh Pandey Sr Manager, Medical Writing, SCEDAM, SIRO Clinpharm Pvt Ltd

FTE/FSP models provide a win-win situation for the sponsors as well as vendors. In collaborative FTE/FSP models, companies get access to a trained and qualified resource pool of the service

provider, without adding additional overhead costs. Also, having the same set of resources working across multiple projects over a period of time helps to bring in efficiency by implementing learning from the previous projects and thus translates into direct cost savings for the pharma company. Besides the operational efficiencies in strategic partnership models, companies also save significant time spent in contract negotiations for each independent project. Vendors prefer this model as it assures revenue continuity for them and avoids the need of entering into a new contract for every study and it also provides them with better visibility. The outsourcing of knowledgebased services like Clinical Data Management (CDM), biostatistics and medical writing from large biopharma companies to the Asia Pacific region is continuously on the rise. Medical writing is a niche domain that has gained huge momentum in the outsourcing industry since the last decade as companies are looking for faster ways to bring safe and effective medicines to the market and maximise their benefits. According to a Centerwatch report, the medical writing market has grown by 15 per cent yearon-year and it has almost doubled from $345 million in 2003 to approximately $694 million in 2008.

Preview: Medical wri ng Medical writing is about communicating scientific and clinical information about drugs, biologicals and devices to a varied audience including regulators, clinicians, patients, as well as the scientific community in a clear, unbiased and accurate manner. Modern Pharmaceuticals I July 2011

Clinical Research Medical writing can be categorised into Preclinical and Clinical writing. Preclinical writing: Preclinical writing primarily involves the writing of documents for the drug discovery phase, eg, preclinical study reports, toxicological reports, preclinical summaries and overviews, preclinical publications, etc. Clinical writing: Clinical writing involves documents related to drug development and the post-marketing phase. It can be categorised as follows: Regulatory medical writing: Regulatory medical writing covers the major share of the medical writing market and this involves preparing different documents required as per law by regulatory agencies. For example: Clinical study protocols Patient information sheet and informed consent forms and assent forms Investigators brochures Clinical study reports Annual Safety Reports (ASRs) and Periodic Safety Update Reports (PSURs) Periodic Adverse Drug Experience Reports (PADERS) and safety narratives Clinical overviews and summaries Integrated summaries of safety and efficacy Package inserts (prescribing information for physicians) Clinical trial registry summaries and PhRMA web synopsis Publication writing: Publication writing, a more niche segment, primarily involves the writing of manuscripts, review articles, case reports, letters to editors for publication in scientific and medical journals and the preparation of posters and presentations for various scientific conferences. The huge increase in the number of scientific and biomedical journals since the last decade, including online journals shows the necessity and growing importance of publications in the healthcare industry. Medico-Marketing: This involves the preparation of promotional product literature, product handouts, training material for medical sales representatives, etc. Medical education material: This includes the preparation of articles, slide decks, e-learning modules for nurses, physicians and pharmacists for Continued Medical Education (CME). Textbooks and chapters and patient education materials are also included. The audience for medical writers may be regulators, academicians, research scientists, physicians, medical sales representatives and patients. There are distinct requirements for different types of documents depending on the purpose, phase of the trial and the audience for the document. In addition, within a particular kind of document, depending on the therapeutic area, study methodology and results, there may be huge variations in presentation and writing style and as it is important to communicate correct information in a precise and succinct manner, it is said that medical writing is a combination of art and science. July 2011 I Modern Pharmaceuticals

Clinical Research Ge ng into it Earlier in developed countries, a degree in English held higher priority and these professionals were provided clinical training. However, now the trend has changed. Medical writers need to possess a portfolio of skills, including a background in medical sciences, life sciences or pharmaceutical sciences, along with a good command over English and a flair for writing, a sound understanding of research methodology, biostatistics and basic Microsoft Office skills. Many companies do hire copy editors to support scientific writers. Since the last decade, India is seen as a key destination for the outsourcing of medical writing, leading to a huge demand for well trained and experienced medical writers in the industry. Though India has a huge English speaking, scientific and medical community, there is scarcity of an employable talent pool because of a lack of formal education and industry experience in medical writing and the shortage of professional medical writing training programmes. The scarcity of the trained talent pool in the industry results in attrition and the need to attract and retain talent ultimately leads to spiralling wages and adding to costs. This talent crunch of professionally trained medical writers in the Indian healthcare industry may strangulate India’s growth story, and hence it is very important for the industry to self-regulate and manage its needs. Various companies are trying to manage the scarcity of resources in

their own ways such as enhancing the industry and academia partnership to have a supply of employable talent pool, conducting education and professional training programmes, internships and cross functional trainings of the resources in other domains. Recently, SIRO Clinpharm, launched the ‘Centre of Excellence for Medical Writing’ which offers basic and advanced certificate courses in medical writing, based on an industry aligned curriculum. Due to the spurt in the demand of medical writers in the industry, a lot of young people working in other allied domains like pharmacovigilance, medical affairs, CDM or medical transcription streams in CROs, Business Process Outsourcing (BPOs), Knowledge Process Outsourcing (KPOs) or pharma companies are seeking out training programmes in medical writing, to build a career in this niche domain. Adequate availability of skilled and trained resources helps the industry to a great extent in keeping a reasonable resource cost control over a period of time and also helps to quickly ramp up the teams if required. While hiring medical writers, it is critical to evaluate and identify people with the right skill sets, and attitude. Apart from a command over English, soft skills like analytical and logical thinking, an eye for details, a passion for reading and writing, multitasking and organisational capabilities are also important. Adequate time should be invested in onboarding and providing

Classiﬁca on Medical writing

Clinical

Regulatory Publication writing writing

Medicomarketing

Preclinical

Medical education

Preclinical study reports, toxicological study reports, preclinical summaries, preclinical publications

functional training. Effective and thorough training on International Conference on Harmonisation (ICH) guidelines, regulatory requirements for USFDA & European Medical Agency, Consolidated Standards for Reporting of trials (CONSORT), International Committee of Medical Journal Editors (ICMJE), Writing style (eg, AMA style manual), key therapeutic areas and biostatistics go a long way in ensuring quality. Use of tools such as standard templates, checklists, document management and tracking systems, project management tools and innovative tools like macros help writers to make the process leaner.

Collaborate to grow... The skilled resources for knowledgebased services like CDM, biostatistics and medical writing are available in emerging markets at significantly lower costs. While cost is one of the key factors for strategic outsourcing, for the selection of long term strategic CRO partners, companies do focus primarily on the competencies of the resources, their domain expertise, and thus their ability to deliver the defined quality as per service level agreements per timelines. It is imperative for service providers to foster a culture of innovation at work and to focus on process improvements and efficiencies to remain competitive in the business. To summarise, biopharma companies will continue to establish strategic partnerships for knowledgebased business critical services like medical writing to keep R&D costs under control. Hiring people with right sets of skills and attitude and investing adequate time in proper training on regulations, guidelines and technical aspects, culture of innovation and smart thinking helps drive strategic partnerships. Long term strategic collaborations will help the pharma industry to bring cost-effective medicines at affordable prices in the market. MPh (Rajesh.Pandey@siroclinpharm.com) Modern Pharmaceuticals I July 2011

Interface

‘Peristal c pumps can handle a wide variety of fluids-including fluids that are sterile, shear-sensi ve, highly viscous or chemically aggressive’ …says Philip Nyren, Product Group Manager, Cole-Parmer. Discussing the use, applica ons and advantages of peristal c pumps, Nyren explains the solu ons that help customers do their jobs. Meghna Mukherjee & Arshia Khan moves into place. This compression Kindly state the use and func onality of peristal c pumps in the pharmaceu cal industry and explain how this technology is cost-effec ve? Peristaltic pumps are suitable for the dispensing, metering and general transfer of fluids. They are used in the pharmaceutical sector for

cycle essentially pushes the fluid through the tubing. Peristaltic pumps confine the fluid to the tubing. The benefit is that the pump cannot contaminate the fluid and the fluid cannot contaminate the pump. This contamination-free pumping makes peristaltic pumps great for use in high-purity applications, including the transfer or dosing of chemicals and

Peristal c pumps are extremely cost-eﬀec ve. Their only rou ne maintenance requirement is that the user periodically needs to change the tubing.

media transfer, dosing, dispensing, filling, acid–base control and other applications. Peristaltic pumps are well suited to pumping a variety of fluids. The fluid is contained in a flexible tube that is fitted tightly within the pump. A rotating set of rollers alternately compress and relax the tubing. As the tube relaxes, the resulting vaccuum draws fluid forward and this pocket of fluid is then captured as the next roller 60

additives in food, pharmaceutical and semiconductor applications. Peristaltic pumps are extremely cost-effective. Their only routine maintenance requirement is that the user periodically needs to change the tubing. Since the fluid is confined to the tubing, a peristaltic pump requires little down time compared to other pumping technologies. There is no need to disassemble the pump or to

take it off line for cleaning or service. Our peristaltic tubing pumps offer flow rates as low as 0.00001 mL/min and up to 37 LPM and are able to generate pressures up to 10.2 bar (150 psi).

Describe a few of the applica ons for peristal c pumps in the pharmaceu cal industry. And, are these pumps FDA/USP compliant? Peristaltic pumps are used for pumping shear sensitive, high-purity and sterile fluids. Some common applications of peristaltic pumps include media transfer, dosing and filling, pumping process intermediates, pumping IV fluids through an infusion device and numerous other applications where isolation of the product from the environment is critical. Cole-Parmer is a knowledge and solutions-based company. Our sales and applications team visit pump users to fully understand their application needs. This assessment typically includes checking the fluid flow rate, regulatory needs, drive control and accuracy requirements, fluid/tubing compatibility and other application parameters and requirements of the end user. We offer peristaltic pumps suitable for use in labs, pilot plants, process and Original Equipment Manufacturer (OEM) applications. From low-cost fixed-speed pumps to remote and computer-controlled models suitable for critical metering and dispensing applications, Cole-Parmer can offer an appropriate pump solution. Modern Pharmaceuticals I July 2011

Interface

Online filling system with Masterflex Peristaltic Pumps

Many of the available pump tubing formulations are both Food and Drug Administration (FDA) and US Pharmacopoeia (USP) compliant, ensuring that regulatory compliance can be strictly maintained and documented.

State some of the cri cal features of the tubing and also if there are any safety concerns. The only part of a peristaltic pump that comes in contact with the liquid is the tubing. It is the heart of the pump. Masterflexâ&#x201E;˘ pump tubing is manufactured to strict tolerances precisely matched to the design of the pump itself. We have as many as 21 different formulations of tubing available for our pumps. This wide variety enables us to match the customer requirements for cost, chemical compatibility, pumping life, regulatory compliance, and flow and pressure needs. Our sales and applications team asks the correct questions to ensure that the best tubing for any particular application is a component of the overall solution that we recommend. The pump system needs to be delivered according to the expectations of the end user. The most vital safety concern is that the tubing is chemically compatible with the fluid being July 2011 I Modern Pharmaceuticals

pumped. We have a database of actual test data that we consult when making our recommendations

What are the advantages of peristal c pumps over other pumps? In comparison to other technologies, the main advantages are low maintenance, ease of use and longterm value of peristaltics. They can handle a wide variety of fluids- including fluids that are sterile, shear-sensitive, highly viscous or chemically aggressive. Their versatility is even more impressive when you consider that in applications wherein you need a single pump to handle different fluids, changing over is as simple as loading a new piece of tubing. There is no need to strip down and clean the pump before or after changing fluids. The service life of peristaltic pumps is quite long, which further increases their long-term value.

What are the latest developments in peristal c pump technology? Recent developments include some of the newer formulations of pump tubing as well as improvements in control electronics. We have several newer formulations of tubing that

are actually two distinct layersâ&#x20AC;&#x201D;an inner layer and an outer layer. In one example, the inner layer is compatible with a wide range of challenging and aggressive chemicals while the outer layer is very long lasting. Remember, the fluid only contacts the inner surface of the tubing. This solution avoids the compromise common with some of the traditional options for aggressive chemicals: many of those formulations did not last very long in the pump. So in a sense, these new dual-layer tubing formulations give the user the best of two worlds. Advancements in control electronics and motor technology have given us long-lasting, brushless motors that can be accurately controlled at very low speeds. This has enabled us to engineer pump drives that offer flow rates as low as the 0.00001 mL/min referenced earlier.

How o en would a company require a er sales service for these pumps? These are low-maintenance pumps and typically do not need any routine service. The tubing is the only wetted part and needs to be replaced periodically depending on the specific parameters of the application. Tubing changes take no more than a few minutes and can be accomplished with only minimal training.

Are there other companies who supply these pumps? There are other global companies including IDEX and WatsonMarlow, and also a number of local manufacturers.

Who are your clients? Within the pharmaceutical industry, almost every other company is our client. Apart from pharma, we have our clientele in the chemical, paints and pigments, electronic, water and wastewater, and food & beverage industries as well as governmentowned research institutes. MPh (arshia.khan@infomedia18.in)

Interface

‘High precision analy cal instruments are not presently manufactured in India and the industry s ll relies on import’ …says Dr K V Krishnan, Prac ce Head, Life Sciences, Mindteck. With a doctoral degree in Analy cal Spectroscopy and an experience of over 29 years in the life sciences ver cal, one of the leaders at Mindteck shares his exper se on the present and future industrial scenario. Parita Dholakia

the engineering bandwidth within the organisation Meet the regulatory/compliance requirements

Tell us how Mindteck helps a pharma company in achieving performance op misa on along with cost reduc on. Mindteck works in all areas of life sciences, with a strong focus on pharma industry. We provide a strong set of product engineering and IT

IT has become an indispensible factor for almost all sectors. How important is it for the healthcare industry? IT covers all aspects of requirements of

Medical devices that oﬀer less invasive treatment op ons, with be er clinical outcomes and shorter recovery mes, will create tremendous value in the next few years.

service offerings to our clients in pharma business. Our offerings are comprehensive and cover software development, electronic design and independent verification & validation apart from other support services. Our technical solutions help life science companies to: Reduce product development cycle time and quicker time to market Increase productivity by enhancing 64

hospital, pharmacy, clinic and health insurance units. Drug development, clinical trials data management, Electronic Medical Records (EMRs), Electronic Health Records (EHRs) are the major areas where IT plays a dominant role in healthcare. Patients are able to identify the best healthcare personnel and doctors are able to gain comprehensive patient view with the help of healthcare IT. Labs

and hospitals are able to integrate the data with medical equipments, enable token issue system, display boards, etc, using today’s IT services available for the healthcare industry. Hospital management solutions provide multiple functionalities for patient care, clinical lab management, hospital administration and other ancillary services such as financial management, human resource management and supply chain management.

Over a period of me, has the approach of pharma companies changed for IT-based solu ons? Pharma industry is loaded with a huge volume of information, and inefficiencies do exist in searching and retrieving data. So, issues related to information sharing and management of knowledge assets require IT-based solutions. Better utilisation of data and shortened time to market can lead to time saving up to 1 year per drug. Due to these factors, the global approach of pharma companies has rapidly changed for IT-based solutions. Today, IT investments are widely spread across various functions of the pharmaceuticals industry such as R&D, clinical development, manufacturing/ supply chain, sales, marketing and corporate management.

How has Mindteck kept pace with the technological evolu on? The life sciences segment encompass companies in the fields of scientific instruments pharmaceuticals, medical devices, biotechnology, food processing, Modern Pharmaceuticals I July 2011

Interface environmental and organisations and institutions that devote a majority of their efforts in the various stages of research, development, technology transfer and commercialisation. In all these segments, global players are witnessing number of key technology trends such as convergence and mobility, cloud computing, adoption of energy efficient technologies, enterprise adoption of Web 2.0 etc, that are impacting their business. Hence, it is essential for any vendor to keep pace with these technologies. We have been actively focussing on the emerging trends of the industry and are currently equipped with exclusive centres of excellence in all the above areas.

How important is quality adherence for such solu ons? How does one monitor and evaluate the same? Quality adherence is very critical when you offer solutions to medical device and other segments of life sciences industry as they are extensively governed by strict regulations. Mindteck is well accredited by international quality standards. Apart from being ISO 9000 certified, we also possesses ISO 13485 accreditation, which is essential for providing services to medical devices industry. Information security is another important concern of this industry, which is taken care of through our ISO 27000 certification.

Experts from the pharma machinery industry believe that we s ll need to import a few products such as analy cal lab instruments. Your take. It is true! Since pharma industry relies on the precision and accuracy of analytical instruments to obtain valid data for its various functions, such high precision analytical instruments involving various characterisation techniques are not presently manufactured in India and the industry still relies on import. July 2011 I Modern Pharmaceuticals

Service preview Modern pharma labs need a large number of chromatography analyses of samples, but at the same time they do not invest in the same brand of instrument for various obvious reasons. This has resulted in the concept of Chromatography Data Systems (CDSs), which enable the user to control, acquire and analyse data from instruments of multiple vendors. Such interoperability requires multiple device integration with the specific CDS. Mindteck has specialised service offerings in this area that is supported by two state-of-the-art in-house analytical instrument laboratories. Today, they possess rich expertise in all the available CDS apart from having worked in all the areas of separation sciences from Flash Chromatography to Ultra Performance Liquid Chromatography (UPLC) and Supercritical Fluid Chromatography (SFC).

How do you perceive the future of the medical device and pharmaceu cal industry? There has been a technological revolution in the medical device industry in recent years. The pace of medical invention is accelerating with the convergence of many scientific and technology breakthroughs. These medical technology innovations are bound to fundamentally transform the scenario by providing new solutions that will challenge the existing paradigms. Medical devices that offer less invasive treatment options, with better clinical outcomes and shorter recovery times, will create tremendous value in the next few years.

With some average ďŹ gures for the FY 2010, how is Mindteck planning to surge back in the proďŹ t-making charts? Our revenues have grown to ` 240.87crore for FY11, as against ` 226.54 crore during FY10. Profit After Tax (PAT) for the year also grew to ` 9.14 crore, as against ` 3.35 crore last fiscal. A significant part of this profit can be attributed to the life sciences vertical. And now with our renewed vertical focussed approach, we are keen on acquiring deeper customer domain knowledge and experience. Such a goforward business strategy is bound to enable dramatically faster growth than the industry average. As mentioned earlier, we have an anticipated growth of around 60 to 70 per cent this year for the life sciences business.

Can you an provide example that explains how Mindteck helped a pharma company achieve the desired results? The life sciences industry in general and pharmaceutical industry in particular is governed by a stream of regulatory requirements. For example, the pharma industry relies on the precision and accuracy of analytical instruments to obtain valid data for research, development, manufacturing, and quality control. Regulatory agencies require pharmaceutical companies to establish procedures assuring that the instruments supporting regulated product testing are fit for use. Analytical Instrument Qualification (AIQ) is the documented evidence that an instrument performs suitably for its intended purpose and that it is properly maintained and calibrated. Use of a qualified instrument in analyses contributes to confidence in the veracity of generated data. Of late, many automated protocols are provided by instrument manufacturers to perform such qualifications. Recently, Mindteck developed such a qualification protocol for a series of gas chromatographs that are extensively used in pharmaceutical industry. With strong domain knowledge in method development supported by technological expertise, we were able to provide a valuable solution to pharma industry through to a leading life science instrument manufacturer. MPh (parita.dholakia@infomedia18.in)

Industry Insights

Global cancer vaccines market

High unmet needs Rising incidences of cancer warrants equal high treatment costs. Con nuous research coupled with advances in molecular biology, gene cs, genomics, proteomics have led to the iden ďŹ ca on of novel molecular targets for cancer therapy and preven on. One such major breakthroughs is the cancer vaccine. Presently, there are high unmet needs that these vaccines can cater to. An analysis. Cervical cancer vaccines market, global, revenue and market forecasts ($ billion), 2001â&#x20AC;&#x201C;2017 2.5 CAGR (2009-2017): 5%

Revenues ($ billion)

2.0

1.5 CAGR (2001-2009): 82% 1.0

0.5

0 2001

2009

2017

Source: GlobalData, GlobalData Sales-based Market Forecasting Model, Primary Research Interviews, KOL Interviews

t present, the global cancer vaccines market is occupied by cervical and prostate cancer vaccines. The vaccines available for cervical cancer are all prophylactic; the brands are Gardasil and Cervarix. The only therapeutic vaccine available in the market is Provenge from Dendreon Corporation. The global cervical cancer vaccine market in 2009 was worth $1.41 billion. GlobalData has estimated that the global cervical cancer market will grow at a Compounded Annual Growth Rate (CAGR) of 5 per cent to reach $2.10 billion in 2017. The cost of three complete dose courses of cervical cancer vaccines ranges from approximately $380 to $390.

The global prostate cancer vaccine market was $70million in 2010. It is expected to reach $2.3 billion in 2017, growing at a CAGR of 66 per cent. The present pipeline for cancer vaccines seems to be very promising, with numerous molecules present in the phase II and III stages. From a market perspective, there are going to be multiple vaccine launches between 2011 and 20132015, which is expected to significantly increase the market size and drive growth.

Weak compe on in the global vaccines market At present, the global cancer vaccines market is occupied by cervical and

prostate cancer vaccines. The launch of these vaccines has renewed interest in the development of vaccines for cancer. Though the therapeutic vaccines were in the pipeline for a long period of time, none of them is able to overcome the regulatory barrier except Provenge. Provenge gained Food and Drug Administration (FDA) approval on April 29, 2010 and is indicated in the treatment of metastatic castrationresistant (hormone refractory) prostate cancer. Manufacturers have faced trouble proving the efficacy and safety of these vaccines along with demanding manufacturing guidelines. The market is waiting for a paradigm shift in the treatment of cancer through the introduction of new therapeutic vaccines that have a more targeted approach.

High unmet needs The current cancer vaccine market offers limited options for both prophylactic and therapeutic vaccines, which presents huge unmet needs. The unmet need is high when it comes to treating the existing condition. With the rising incidence of cancer, there is a huge patient population waiting for a new approach in the management of cancer. There is a need for more therapeutic vaccines to treat the condition. To achieve success and exploit the maximum market potential, the new entrant must be a successful therapeutic option. Therapeutic cancer vaccines have huge market potential as they have the capability to address this unmet need. Modern Pharmaceuticals I July 2011

Industry Insights

GlobalDataâ&#x20AC;&#x2122;s analysis indicates that the available options in the market are very successful in the area of prevention but the market has few options for treating the condition. The only approved cancer vaccine for treatment is Provenge, which is indicated for prostate cancer. Prophylactic vaccines are efficacious in offering protection against cervical cancer. However, for the patient population who are already suffering from the disease, there are a limited number of effective drug treatment options available. There is a moderate unmet need, especially for people who develop metastatic disease. There is immense market potential for any new entrant that can cater to these unmet needs.

July 2011 I Modern Pharmaceuticals

Efficacy High

Low

Currently available cervical cancer vaccine provide protection against four types (types 6, 11, 16, 18) of Human papillomavirus (HPV)

Safety

Current market

Opportunity and unmet needs in the global cancer vaccines market, October 2010

Low

They have a targeted approach and also have fewer side effects compared to other chemotherapy options. They will provide or increase the options available for cancer treatment.

Cerverix

High

Unmet need-Perceived unmet need is moderate. There is requirement for a broad spectrum multivalent cervical cancer vaccine which provides the protection against other types of HPV

Gardasil Next steps-Unmet need can be fulfilled only by introducing multiv alent broad spectrum cervical cancer vaccine Unmet need indicates the adverse events and efficacy associated with marketed vaccines Size of the bubble represents approximate cost effectiv eness of the product Source: GlobalData

There is a huge market potential for any new therapeutic vaccines for cancers than that of the prostate. These vaccines, if successful, will be the first of their kind to enter the market and will surpass the sales of the prophylactic vaccines. Thus, though the prophylactic vaccines are successful in prevention and have the capability to reduce

the population needing treatment, there is still a commercial opportunity in the area of drug treatment for people who develop the disease. These prophylactic vaccines will continue to primary form of market activity until an effective drug treatment option arrives. MPh Courtesy: GlobalData

Case Study

Vision sensors for pharma manufacturing

Raising the bar for quality assurance This ar cle chronicles how Genesis developed the new inspec on system for a major pharmaceu cal manufacturer, and explores how the lessons learned from ini al feasibility study through ďŹ nal system integra on were applied to a new stand-alone raised stopper detec on sta on.

ials are small. The rubber stoppers that go in them, even smaller. But small things can lead to big problems for pharmaceutical manufacturers. Prior to capping and sealing, the rubber stopper in a vial must be seated properly. If it is not, costly product could be spilled or sterility compromised. Genesis Machinery Products found that vision sensors work much better than

photoelectric sensors when it comes to checking vials for raised stoppers. Vision sensors are less error-prone, more accurate, repeatable and provide consistent results regardless of normal product-to-product inconsistencies. For pharmaceutical manufacturers, the new vision-based inspection system streamlines product changeovers, minimises waste and provides data for better tracking of rejects.

Vision sensors for raised stoppers

Didier Lacroix Senior Vice President, Worldwide Sales & Marketing, Cognex Inc

When it comes to packaging vaccines or other injectable medicines for patient treatment, pharmaceutical manufacturers can ill afford to take risks. That is why Genesis Machinery Products, manufacturer of high-tech pharmaceutical grade packaging systems with expertise in seal integrity, switched

from photoeletric sensors to vision sensors on a new vial inspection system that has been deployed at a leading pharmaceutical manufacturer. The new system has helped the pharma company to improve the repeatability of the process, while minimising downtime, changeover time and process waste. The system uses two In-SightÂŽ 5400 vision systems from Cognex Corp, and provides 100 per cent automatic inspection to detect raised stoppers on vials containing injectable liquid and lyophilised drug products prior to capping and sealing. If the rubber stopper on a vial is not seated properly before entering the capper, two things can go wrong. The stopper could be pulled off and product spilled, or the stopper could be pushed back into the vial and reseated. If this happens, there is a chance that sterility could be compromised without detection. To assure seal integrity during the capping process, Genesis formerly used photo eyes to check for raised stoppers. The set-up required an emitter to send out a very fine beam of light, and an opposing receiver. To work, the emitter and receiver must be mechanically aligned so good vials with properly seated stoppers pass under the beam, and vials with raised stoppers interrupt the beam. When an unseated stopper breaks the beam, the receiver signals the machine to stop so the flawed product can be removed. The photo eye systems got the job done, but they were limited in three ways. First, the system was not truly repeatable. Photo eye alignment Modern Pharmaceuticals I July 2011

Case Study

depended on which operator set it up. Next, product changeovers were time consuming. Photo eyes had to be mechanically adjusted each time the vial type changed. Finally, photo eyes would sometimes reject good product due to variations in vial height due to normal manufacturing inconsistencies. By using In-Sight vision sensors from Cognex, we have taken operator subjectivity out of the equation, tightened the tolerances significantly and improved the process. The vision system is not fooled by normal vial inconsistencies, and changeovers now consist of selecting a new job via keyed entry on a touch screen.

process application that will meet the demanding requirements of a pharmaceutical manufacturer. With Serview’s help, it took only a few days to bridge that gap, and incorporate all the bells and whistles that were required. Serview was instrumental in developing a robust programme, and getting the system up and running.

Detec ng raised stoppers In order to provide full inspection coverage, the final specification required that Genesis integrate two In-Sight 5400 vision sensors into the custombuilt machine. The vision sensors are arranged at right angles to each other to ensure that vials with stoppers that are

Tapping into vision Having dabbled with machine vision before, we thought that vision technology might help improve the photo eye-based system. Cognex was contacted based on the pharmaceutical manufacturer’s recommendation, and a Cognex sales engineer scheduled an onsite evaluation at Genesis. To set up the application, the In-Sight vision spreadsheet interface was used. The process involved selecting vision tools and parameters from drop-down menus. The vision spreadsheet then automatically generated tool results into worksheet cells, which were then linked together to set up the inspection measurements. It was great to be able to configure machine vision the same way one uses a normal spreadsheet, creating formulas and adding logic tools like ‘if/and’ statements. One can also use multiple vision tools and make reference to those tools just by clicking on the cell. In-Sight was easy to use, integrate and set up time was minimal. In order to meet an aggressive customer deadline, Genesis enlisted the consulting services of systems integrator Serview Inc to help bring the demo application up to the next level. There is a big difference between inspecting a vial sitting on a desk and developing a high-speed, rock-solid July 2011 I Modern Pharmaceuticals

It was great to be able to conﬁgure machine vision the same way one uses a normal spreadsheet, crea ng formulas and adding logic tools like ‘if/and’ statements.

cocked do not proceed to the capping machine. When a stopper is cocked, it may appear seated from one view, but not from the other. By using two vision sensors, we can ensure that the stopper is properly seated all the way around the circumference of the vial. During production, a feed screw spaces vials evenly on a conveyor and they are fed into a series of star wheels. The star wheels transport each vial, one at a time, in front of the two cameras at a rate of 600 per minute. Two red LED backlights located behind the vial inspection position help create optimal image contrast between the vial, stopper and background to give the vision sensor the clearest possible view of the measurement area. As a vial enters the field of view and is presented to the cameras, a trigger signal linked to the vision sensor through I/O

is provided to initiate image acquisition. The vision sensor captures the image, and transfers it to the on-board vision processor for analysis where a variety of vision software tools are applied. First, the In-Sight PatFind® pattern matching tool compares each image to a pre-trained reference image of the vial and stopper. It does not matter if the vial height changes due to normal manufacturing variations. PatFind simply looks for the geometric properties of the stopper within the image. Once this match has occurred, PatFind determines the exact X, Y and theta position of the stopper and vial, then fixtures the various vision inspection tools at the right location to measure the distance between the top of the vial and the lip on the stopper. To do this, In-Sight edge detection tools are used to find the edges and then calculate the distance between points on each edge. In addition to the visual information provided to the operator, each In-Sight vision sensor sends pass/fail information to the capping machine controller (PLC) through the I/O lines. A fail signal instructs the PLC to trigger a solenoid actuated reject star wheel mechanism to remove the flawed product from the process prior to capping. Good product proceeds through the capping and sealing machine, and then downstream to the manufacturer’s parenteral packaging area. The flexibility of PatFind completely eliminates the false rejects we used to get from photo eyes. Moreover, PatFind allows the various edge and inspection tools to provide accurate, consistent and truly repeatable results. From a hardware perspective, the In-Sight 5400 is a high-performance machine vision sensor with a die-cast aluminum housing, sealed M12 connectors, and protective lens cover that achieves an IP67 (NEMA 6) rating for dust and wash-down protection.

Opera ng the system Each In-Sight vision sensor includes 71

Case Study

a built-in Ethernet 10/100BASE-T communications port, which connects through an Ethernet switch to a touchpanel computer from Advantech Automation Corp. The Advantech TPC1260 touch-panel computer features a 12.1-inch, high-luminance display and a low-power processor. The TPC-1260 serves as a programming terminal and provides a visual display for the operator. During production, the machine operator can view the inspection image and a green or red pass/fail indicator light on the screen. For product changeovers, the operator selects new jobs via keyed entry on the touch screen. Password protection prevents operators from making unauthorised changes, but when logged in as a programmer, the system can be easily tailored to meet the specific needs of the pharmaceutical manufacturer. For example, enabling the FTP function of the vision sensors allows users to have all images, or only failed images, saved

to the touch panel computer’s hard drive for later review. In addition, the touch-panel computer runs In-Sight Explorer software from Cognex that offers advanced tools to simplify application development and network administration. In-Sight Explorer is intuitive and user friendly. One great benefit is that In-Sight Explorer allows using saved images to modify the application offline. We simply dragged and dropped them into the spreadsheet, then adjusted the parameters to optimise the performance of each vision tool.

Building on success Machine vision has proven invaluable for this application, by allowing Genesis to raise the bar for quality assurance in the production environment. The vision system allows us to advance the notion that when you buy our capper, you also buy our expertise in vial handling and seal integrity. The first system has been installed and is improving

productivity by reducing time and labour costs for the pharmaceutical manufacturer. The system not only helps achieve a better quality product by providing 100 per cent in-line inspection, but it improves accuracy and increases speed as well. The new system was introduced earlier this year in New York at InterPhex on April 26, and will be ideal for pharmaceutical manufacturers interested in retrofitting existing vial capping lines. Machine vision has enabled Genesis to build greater precision and flexibility into the standalone inspection station. With vision, we have the flexibility to easily incorporate other inspection tasks such as checking vial glass for defects, inspecting caps for placement and/or color. We can do OCV, 1D and 2D code reading. By using Cognex vision to do multiple tasks, we can build on our expertise in high-speed vial handling and seal integrity. MPh (sales.in@cognex.com)

An invite that rewards as well... Dear Reader, ‘Modern Pharmaceuticals’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 3000 words, while that of a product write-up should not exceed 200 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will receive a complimentary copy of that particular issue and an honorarium cheque. Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

Modern Pharmaceuticals I July 2011

Tech Mantra

ERP systems upgrada on

Improving performance, achieving sustainability A pharmaceu cal company seamlessly upgraded its SAP system, enabling operators to focus on the core business of making pharma products. Concerns arose about whether exis ng transac ons and links would work, or even exist, once the upgrade was completed. All these were answered.

he goal of a SAP interface system is to alleviate manual data entry into SAP performed by production operators. The SAP interface system helps operators to request production material and product to their suite from the same terminal that is used for operating equipment. A major North American pharmaceutical company implemented its Manufacturing Execution Systems (MES) in 2005 with the help of Grantek Systems Integration, a Rockwell Automation Solution Provider. The pharma company needed to upgrade its corporate SAP system from SAP R/3 4.6C to SAP ECC 6.0. The focus of the upgrade was on the technical aspects and the impact on the validated systems.

Tes ng is vital for migra on A

pharmaceutical

company

July 2011 I Modern Pharmaceuticals

uses

multiple systems for production. A system controls Self-Guided Vehicles (SGV) to transport material in bins and totes to locations throughout its facility. The tote high bay storage area is controlled by a warehouse controls system. Whenever inventory is moved, a corporate SAP server has to be updated to reflect the inventory’s new location. The company’s previous MES solution completed about 19 different SAP transactions types within the manufacturing suites. Therefore, each of these transactions types had to be tested to ensure the upgraded SAP version worked in the same manner as the previous version. The company also had to ensure all automated data transactions worked correctly. The upgrade team chose to automate the typical SAP operator transactions,

reduce operator training time, ensure 100 per cent accuracy and simplify operator experience in the manufacturing suites. When operators do not need to interact with the SAP graphical interface, they can spend most of their time on the core business of manufacturing pharmaceutical products. Grantek and the pharmaceutical company used a specific method of communicating with SAP for the MES application, called Remote Function Call (RFC). RFC is a standard SAP interface for communication between SAP systems. It calls a function to be executed in a remote system. Derek Kostelnik, Team Leader, Grantek, was confident that the application would upgrade seamlessly. However, he knew that the only way to be sure was to set up the ‘sandbox’ environment and test every transaction. The sandbox is an SAP client built solely for development, testing or training purposes.

Implemen ng the upgrade Grantek’s approach was to implement a variety of Rockwell Software® FactoryTalk® applications before the SAP upgrade. This mitigated potential production downtime and distributed the required validation workload. To accomplish this, the upgraded version of FactoryTalk applications had to be tested against the new version of SAP and the existing SAP version, using several SAP environments. This pharmaceutical manufacturer has three types of SAP environments: Production, Quality Assurance (QA) and Sandbox. 73

Tech Mantra

The production servers are redundant, high-availability servers used in the production environment. The QA servers are identical to the production environment, but all changes first must be validated against the QA servers before they can be migrated to the production environment. The Sandbox environment is the test and development system. Similar to the SAP environments, the company also had two types of FactoryTalk environments: Production and QA. For each phase of the project, Grantek worked with the pharmaceutical company to test MES functions by performing end-to-end testing of each SAP transaction used in each environment. Grantek first performed an investigation to confirm the exact driver version and patch levels installed in the FactoryTalk interface that links the MES system to SAP. Grantek then determined what driver updates and patches were necessary for FactoryTalk to connect to SAP ECC 6.0. Next, Grantek updated the quality server

(QA environment server), and directed it to the pharmaceutical company’s SAP ECC 6.0 Sandbox environment. After successfully completing this testing, Grantek directed the Quality Server to the manufacturer’s SAP ECC 6.0 QA environment.

Implemen ng a variety of Rockwell So ware® FactoryTalk® applica ons before SAP upgrade mi gated poten al produc on down me and distributed the required valida on workload.

Finally, Grantek directed the Quality Server to the manufacturer’s SAP R/3 4.6C QA environment. Once the updated quality server was verified to be fully functional with both SAP R/3 4.6C and SAP ECC 6.0, it could be used in place of

the production servers, while they were taken offline for updates and testing. Next, Grantek updated the production servers and directed them to the Apotex SAP ECC 6.0 QA environment. Grantek then directed the production servers to the manufacturer’s SAP R/3 4.6C QA environment.

Healthy results The pharmaceutical company and Grantek team completed a thorough end-to-end test of all facets of the MES solution. The SAP upgrade to SAP ECC 6.0 was a success. The company scheduled a time to perform the upgrade, and no further work was required – FactoryTalk migrated from SAP R3 4.6C to SAP ECC 6.0 seamlessly. Rockwell Automation and PartnerNetwork companies collaborate to help you develop an ongoing approach to plant-wide optimisation, improve your machine performance and achieve your sustainability objectives. MPh (Courtesy: Grantek Systems Integration, a Rockwell Automation Solution Provider) (For more details contact: dghosh@ra.rockwell.com)

Modern Pharmaceuticals I July 2011

Events Calendar

National RUDRAPUR: Uttarakhand, Sept 23-26, 2011, Gandhi Park AHMEDABAD: Gujarat, Nov 14-17, 2011, Gujarat University Exhibition Hall PUNE: Maharastra, Nov 18-21, 2011, Auto Cluster Exhibition Centre CHENNAI : Tamil Nadu, Dec 8-11, 2011, Chennai Trade Centre

market leaders. This event will provide an excellent opportunity to showcase innovative products and solutions in the industry; October 12-14, 2011; Bombay Exhibition Centre, Mumbai

INDORE: Madhya Pradesh, Jan 6-9, 2012, Poddar Plaza, Nr Gandhi Hall AURANGABAD: Maharashtra, Feb 17-20, 2012, Garware Stadium India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Infomedia 18 Ltd,

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in

For details contact: Sonia Prashar Indo-German Chamber of Commerce Tel: +91 11 26878721 or 26111730 Email: soniaprashar@indo-german.com Website: www.analyticaindia.com

CPhI India 2011

2nd Annual PharmaLytica India This event aims to bring together leading Indian and international experts to examine the key challenges and opportunities for the Indian analytical laboratory industry. It hopes to uncover new avenues to drive innovation and automation, and to formulate effective strategies to meet international standards, etc; July 2628, 2011, The Westin Mumbai Garden City, Mumbai For details contact: UBM India Tel: + 91 22 4046 1466 Email: conferences-india@ubm.com Website: www.pharmalytica-india.com

2nd Pharmac India The three-day event will cater to the pharma and healthcare industry in the country. It aims to attract reputed professionals from the fields of pharmaceutical formulation, herbal products, veterinary drugs, medical & disposal products and pharmaceutical machinery & equipment. The event will have exhibitors such as contract manufacturers, liaison agents, sourcing companies, generic and OTC manufacturers & wholesalers, government suppliers, etc; September 17-19, 2011; Gujarat University Exhibition Hall, Ahmedabad, Gujarat

July 2011 I Modern Pharmaceuticals

For details contact: Orbitz Exhibitions Pvt Ltd Tel: + 91 22 2410 2801 Fax: + 91 22 2410 2805 Email: info@pharmacindia.com Website: www.pharmacindia.com

14th IDMA-APA PAC This event aims to cater to the pharma and research professionals. It will serve as a platform to the professionals in government laboratories and research institutions, approved testing laboratories, machinery manufacturers, academicians and many others. There will be discussions on how to prepare and face the WHO GMP audit, the validation of legacy systems, the regulatory flexibility in acceptable stability studies along with several other aspects; September 23-24, 2011, Hotel InterContinental The Lalit, Mumbai For details contact: Indian Drug Manufacturers’ Association Tel: + 91 9867634383 Email: ppr@idmaindia.com Website: www.idma-assn.com

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

Pharmapack Bombay The event aims to provide an innovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc; February 23-25, 2012, Bombay Exhibition Centre, Mumbai

Analytica Anacon 2011 Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, which aims to bring together the international exhibitors and

For details contact: Intel Trade Fairs & Expositions Pvt Ltd Tel: + 91 22 2862 8126 Fax: + 91 22 2281 9008 Email: intelexpo@vsnl.net Website: www.intelexpo.com

Events Calendar

International BioProcess International China BioProcess International China will be the 3rd annual event organised in China. The main topics of discussion will be on cell culture, cell line engineering, purification and recovery, process characterisation, process analytics, formulation and disposables technologies. The event will be attended by the biopharma companies, scientists, and executives from all over the world; August 22-24, 2011, Grand Hyatt Shanghai, China For details contact: IBC Life Sciences Tel: + 65 6508 2401 Fax: + 65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifesciences.com

CPhI South America This event aims to be a platform where several pharmaceutical manufacturers, biopharmaceutical, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, new product launches and showcase innovations. The event will be attended by the experts from the entire industry; August 24-26, 2011; Transamerica Expo Center, Sau Paulo, Brazil For details contact: CPhl South America 2011 UBM International Media Tel: +31 0 204 099 561 Fax: +31 203 0632 616 Email: rob.sahi@ubm.com Website: www.cphi-sa.com

Medipharm Vietnam Expo 2011 The event aims to offer an unparalled

opportunity for biotechnology and pharma companies, academic research institutions and investors around the world. It will also provide delegates with business opportunities and knowledge transfer; August 24-27, 2011; TBECC, Ho Chi Minh City, Vietnam For details contact: FAST Syst & Mgmt Services Tel: + 84 4 3825 5546 Email: fastsyst@signet.com.sg Website: www.medipharmexpo.com

Inter Med Pharm 2011 This event aims to provide opportunity for the pharma professionals. Key policy makers, trade visitors, pharma analysts, scientists and researchers are expected to gather here. Thus, this event hopes to offer solution to any pharma related query; September 15-17, 2011; Tashkent Republic of Uzbekistan

Fax: +380 44 4968646 Email: monishchenko@pe.com.ua Website: www.publichealth.com.ua

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

Duphat Dubai 2012 For details contact: TNT Productions Inc Tel: +1 703 4060 010 Fax: +1 703 4068 543 Email: mariya@tntexpo.com Website: www.tntexpo.com

Public Health 2011 This international event will be focussing on pharma, techpharm, medical laboratory, emergency medicine, beauty and health products. This exhibition will be catering to various industry needs; October 11-14, 2011; Kiev International Exhibition Center, Kiev, Ukraine For details contact: Premier Expo Tel: +380 44 968645

This event serves as the convergence point for the pharmacists, scientists, researchers, pharma analysts and consultants, key decision makers, product specialists, pharmacy practitioners and trade visitors. There will be discussions on the significance of the pharma industry, the trends that are dominating, and the technology required to manufacture products required in the industry; March 12-14, 2012; Dubai International Convention Centre, Shanghai, UAE For details contact: INDEX速 Conferences & Exhibitions Organisation Est Fax: +971 4 3624718 Email: duphat@index.ae Website: www.index.ae

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

Modern Pharmaceuticals I July 2011

Technology Transfer

Technology Offered As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration. Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side effects are reported to be the advantages of this product. Moreover, this product has already been launched in American market. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy

Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing Intravenous fluids An Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around ` 15 crore. The company can offer consultancy services/ technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party can set up its own factory when it is ready for investments.

Areas of application Pharmaceutical industry Forms of transfer Joint venture, services

technical

Smart Syringe A company offers technology to manufacture single use safety syringe with spring actuated needle stick injury prevention and auto disable mechanism. The design is adaptable to all sizes of syringes commonly used for injection purpose. Areas of application Healthcare industry Forms of transfer Technology licensing, funding, others Herbal nutraceutical formulation for preventive cardiology – obesity A company offers a nutraceutical formulation comprising probiotics that essentially includes Lactobacillus acidophilus and Lactobacillus sporogenes, and medicinal plants, which essentially includes Commiphora weightii & Terminalia belerica. The present formulation functions in a synergistic manner resulting in enhanced curative properties. Areas of application Pharmaceutical industry, healthcare industry Forms of transfer Consultancy, technical services, technology licensing, research partnerships

Share Your Technology Propositions The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column 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. Contact: 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

July 2011 I Modern Pharmaceuticals

Technology Transfer

Technology Requested I V Fluid manufacturing as SME An Indian company needs new and best technology to start manufacture of I V Fluid. Areas of application Medical technology, I V fluid, manufacturing Forms of transfer Technical services, others Disposable Syringes An Indian company is interested in cost effective production line for disposable syringes for both ribbon and blister options. Areas of application Medical industry Forms of transfer Others Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality. Areas of application Biotechnology, engineering, new technology Forms of transfer Consultancy Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate.

Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others Cell lines Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the companyâ&#x20AC;&#x2122;s product lines and service customers/ researchers/scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals. Areas of application Cell culturing - molecular biology Forms of transfer Material supply Extract of medicinal and aromatic plants An Indian company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others Glove automation equipment An Indian company requires technology to produce glove by automation process.

Areas of application Manufacturing especially rubber latex industry Forms of transfer Consultancy

industries, industry and

Kite grading engineering technology A Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff. Areas of application Medical research Forms of transfer Joint venture, partnership Blood Grouping Device An Indian company needs technology for manufacturing blood grouping biomedical device. Areas of application Biomedical Forms of transfer Joint Venture, technology licensing Manufacturing technologies for Montelucast, Rosuvastatin, Ursodeoxy cholic acid, D-biotin An Indian company needs Active Pharmaceutical Ingredient (API) or bulk drug manufacturing technologies for Montelucast, Rosuvastatin, Ursodeoxy cholic acid and D-biotin. Areas of application Pharmaceutical industry Forms of transfer Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016 Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org

For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

Modern Pharmaceuticals I July 2011

Product Inquiry Card

Easy steps to get product info

Product Sourcing Just Got Simpler

1 See the index page in this issue. Every product carries a number. 2 Choose products of your choice from the list. 3 Write their serial numbers (as per the index page) of your chosen product/s one-by-one in the boxes. 4 Fill in your complete contact details. 5 Send it to us at the address printed overleaf.

-1 TIPin the bdouxcets

ur o l Fil th pr of yo d wi er/s en s nd mb nu oice a ch

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f a Ple t you etails tha the d red all requi

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Book Shelf

Guide to Drug Regulatory Aﬀairs Editor: Cantor Verlag Aulendorf Price: ` 14,500 Considering the complexities of the European regulatory environment, the book ‘Guide to Drug Regulatory Affairs’ aims to offer answers to the oft-asked questions of the research and allied fraternity. Divided into four major parts, A, B, C and D, the book serves as an important platform for a comprehensive overview of the relevant European Union (EU) legal and regulatory framework including EU jurisdiction in the field of pharma legislation. One part of the book provides advice on how to compile an Investigational Medicinal Product Dossier (IMPD) and a dossier for marketing authorisation as well as maintaining the marketing authorisation of a medicinal product for human use. Part C of the book explains the legal requirements for special drug products, eg, orphan drugs, radiopharmaceuticals, blood and blood products, traditional herbal medicinal products and advanced technology medicinal products. Part D provides information with the help of an extensive index of abbreviations along with an index of terms and definitions. This book is extremely helpful for pharma professionals, researchers and students.

EC Guide to Good Manufacturing Prac ce for Medicinal Products for Human and Veterinary Use Editor: Cantor Verlag Aulendorf Price: ` 3,950 The pharma industry of European Union (EU) maintains high standards of quality assurance in the development, manufacture and control of medicinal products. This book shows a list of guidelines that will be used in assessing applications for manufacturing authorisations. The book also helps in inspection of manufacturers of medicinal products. This book is presented in two parts. While Part I covers Good Manufacturing Practice (GMP) principles for the manufacturing of medicinal products, Part II encompasses the GMP principles for active substances used as starting materials. These parts are subdivided into several chapters. Chapter 1 on quality management outlines the fundamental concept of quality assurance as applied to the manufacturing of medicinal products. Another chapter shows the quality assurance objectives and details the essential matters to be considered when implementing the principles. However, this book is not intended to place any restraint upon the development of any new concept or new technologies that have been validated. This book serves as a systematic guide to the drug manufacturers. Further, it can also be considered as an aid to the researchers and pharmacy students. Available at: Wisdom Book Distributors, Hornby Building, 1st floor, 174, D N Road, Mumbai 400 001 • Tel: 022-2207 4484/6631 8958 • Telefax: 022-2203 4058 • Email: thadam@vsnl.com

July 2011 I Modern Pharmaceuticals

Product Update Spectrophotometer

Ice ﬂaker

Cole-Parmer offers Spectronic™ 200, a visible spectrophotometer. The system incorporates the latest optical and detector technologies specific to the needs of academic and industrial quality control laboratories. It is a costeffective instrument built exclusively for teaching and basic testing applications in busy labs. Its durability is ensured by a design with no internal moving parts and tough, corrosion-resistant polymer housing. Results are displayed on a full-colour, LCD graphics screen with variable angle positioning, providing improved clarity of information display. The system delivers quick and convenient measurements. The programmable analyser mode supports mathematical manipulation of measured data and puts the calculated result right on the display. The side compartments accommodate cuvette racks for easy accessibility and high throughput. Sample compartment accepts standard 10-mm square cuvettes and test tube cuvettes from 13- to 25-mm diameter. Optional holders are available for cylindrical or rectangular long-path cells. The sample compartment is corrosion resistant and able to contain spills up to 250 ml; the entire compartment simply lifts out for cleaning. Compact, simple and containing no moving parts, the Spectronic™ 200 is low maintenance and designed to save time and money.

Sigmatech Scientific Products offers an ice flaker manufactured by Pooja Lab Equipments. It produces clear, hard, slow melting uniform quality flake ice. By using environment friendly refrigerant, it offers utmost reliability and performance. Higher capacity industrial cooling system is provided with hermitically sealed super performance and trouble-free compressor of Kirlosker Copeland (CE approved) coupled with air-cooled condenser and direct expansion. The machine offers self-contained ice producer with well-insulated ice storage bin and a variety of capacities. Ice flaker system MOC in non-GMP bin are corrosion resistant, SS-304 mirror finish and exterior is MS powder coated. In GMP bin is SS-316 and exterior is SS-304 mat finish. Guaranteed ice production at 20ºC air and 15ºC DM water temperature. At an extra cost, this is supplied with water filter and water failure protection device by considering that the unit will not run in case of failed water supply and starts automatically once the supply resumes. Sigmatech Scien ﬁc Products, Hyderabad - Andhra Pradesh Tel: 040 - 6453 4491, 098496 32904, Fax: 040-4003 1896 Email: s_tech07@yahoo.com

Fluid bed dryer

Peak Scientific India offers Genius2 gas generators. These are designed specifically as a stand-alone system to provide gas to single LCMS applications. which require a high nitrogen flow. Its higher output and small footprint makes it the perfect prodigy. The new 3010, 3020 and 3030 Genius2 generators have the unique benefit of double the gas flow, supporting multiple instruments with individual control, all built into one, space-saving casing.

Aero Therm offers fluid bed dryer having batch capacity of 15 to 500 kg. A digital temperature indicator controller gives accurate temperature control. The control action can be switched on-off or PID as per control accuracy required. Construction of dryer can be made of ms /aluminium/ss 316/ss 304 as per requirement. Flame proof & spark proof version is also available. Heating can be electrical/thermic fluid or ired hot air generator.

Peak Scien ﬁc India - Secunderabad - Andhra Pradesh Tel: 040-2780 0663, Fax: 040-2780 0663 Mob: 098660 55177 Email: skarra@peakscientific.com

Aero Therm Systems Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2589 0158, Fax: 079-2583 4987 Mob: 098250 08720 Email: contact@aerothermsystems.com

Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222/ 209, Fax: 022-6716 2211 Email: response@coleparmer.in

Gas generator

82 82

steam

radiator/oil

Modern Pharmaceuticals I July 2011

Product Update Vial & bo le cap sealing machine Anju Pharmaceuticals offers vial and bottle cap sealing machines that are compact, versatile and elegantly finished devices for sealing vials & bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium or plastic caps. The vials ready for sealing are placed one-by-one on the selflifting stainless steel platform. This platform lifts upward automatically. As a result, the vials touch the sealing head. Sufficient time is provided to remove the vial platform after the completion of sealing operation. The features of the machine include: perfect & uniform sealing, therefore no manual involvement; no repeated setting required; sealing rollers rotate on bearings to give smooth motion for uniform sealing; minimum time require for changeover from one size of vial to another and does not require lubrication. Anju Pharmaceu cals - Indore - Madhya Pradesh Tel: 0731-252 3968/7415, Fax: 0731-285 6142 Email: anjupharma@hotmail.com

July 2011 I Modern Pharmaceuticals

Product Update Data logger

Vibratory separator

Testo India offers new range of data loggers. The company offers three new series of data loggers. The 174 series: available in two variants to measure temperature, and humidity and temperature. With the larger display and huge memory capacity, these loggers give a great thrust to the price performance ratio. The 175 series: takes a huge leap forward than the last series, sharing the same number in terms of display size and memory capacity, in addition it gives a facility of reading data from the logger via a mini USB port. The 176 series: replaces the old 177 & 171 series of loggers. With the metal housing and finish, it stands out from all other series available in the market in its class. These new age loggers have humidity, temperature and absolute pressure in one. These have new high accuracy point of 100 probe for special applications, offers easy to read large dual line display. It has new age read out possibilities USB & SD card and has new software, which is more graphical and user friendly.

Guan Yu offers a wide range of separators/sifters. These are widely used in industries such as pharmaceuticals, foodstuff, ceramics, chemicals, biochemicals, elctronics, plastics, grinding, water-treatment, recycling, etc. The company also offers specialised machinery and technical solutions that meet specific demands of the customers. Guan Yu Machinery Factory Co Ltd - Chang-Hua Hsien - Taiwan Tel: +886-4-896 5198, Fax: +886-4-896 3598 Email: tracy.yen@guan-yu.net

Encapsulated screw air compressor

Vacunair Engineering offers an axial flow fan. To achieve high efficiency, this axial flow fan has a defined hub ratio of 71 to 25 for a given capacity, pressure and speed. This is available in 22 sizes ranging from 225 to 2500 mm in each type. Drive available for direct mounting/vee belt drive. The impeller blades are adjustable type and rest at designed angle to suit capacity & in-series for higher pressure. The impellers or aerofoil profile are made of cast aluminium alloy. Bifurcated type fan is available for handling corrosive gases. The range covers fans in capacity up to 3,00,000 m3/hr and pressure up to 100 mm of WG.

Elgi Equipments offers E-series screw air compressors. These compressors feature encapsulated airend, with all functional components (airend, suction valve, suction filter, oil separator, oil filter, auto temperature control valve and pressure control valve) contained within a single compact frame. The design of compressors allows ease of access to all standard components for servicing. All standard components are positioned at the front of the compressor thus allowing immediate access by simply removing the panel. The separator element is also conveniently located for easy service. There is no tubing to disconnect, which prevents leakages and saves service time. The amount of oil carried over is minimised. It also eliminates most of the external piping. This in turn minimises leakages and pressure losses. The encapsulation reduces the noise level of the compressor considerably. The main components such as the motor and airend are mounted onto a sturdy and vibration-free base plate that absorbs vibrations and reduces noise levels. The new series of compressor are designed to operate over a wide temperature range of -10Â°C to 40Â°C. The greater air flow generated by the electric fan provides for efficient cooling even during continuous use and in higher ambient temperatures.

Vacunair Engineering Co Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2291 0771, Fax: 079-2291 0770, Mob: 098240 36375 Email: info@vacunair.com

Elgi Equipments Ltd - Coimbatore - Tamil Nadu Tel: 0422-2589326, Fax: 0422-2573697, Mob: 09790039326 Email: enquiry@elgi.com

Testo India Pvt Ltd - Pune - Maharashtra Tel: 020-2563 5075/85/95, Fax: 020-2563 6080 Email: info@testoindia.com

Axial ďŹ&#x201A;ow fan

84 84

Modern Pharmaceuticals I July 2011

Product Update Near-infrared spectrometer Thermo Fisher Scientific Inc offers Thermo Scientific TruProcess analyser, the next-generation nearinfrared (NIR) spectrometer for realtime blend analysis, drying and other Process Analytical Technology (PAT) applications. The TruProcessâ&#x201E;˘ analyser demonstrates the proven precision of a benchtop system and is easily integrated into existing manufacturing processes. The analyser provides fast, reliable, real-time process analysis while optimising manufacturing throughput, ensuring product quality and lowering production costs. In addition, the analyser includes Micro-Electro-Mechanical Systems (MEMS) technology that transforms traditional NIR spectroscopy into a process-line NIR sensor. The small and lightweight enclosure of TruProcess permits interface with the widest range of pharmaceutical process equipment. It features an integrated position sensor and wireless communications, can complete a scan within one second, and has the ability to monitor blending rates of up to 25 RPMs. The analyser is also compatible with Thermo Scientific Method Development software to allow for both qualitative and quantitative applications including drying, blending and moisture analysis. Thermo Fisher Scien ďŹ c - Pune - Maharashtra Tel: 020 6626 7000, Fax: 020 6626 7001 Email: Info.mc.in@thermofisher.com

On-line TOC analyser MeasureTest Corporation offers On-line TOC analyser from Anatel of USA. This can be measured both on and off-line. Off-line measurements (laboratory methods) are typically used for high concentrations (>1 ppm). On-line measurements are typically used for sub-ppm (<1000ppb) detection and quicker response than the lab methods. Most industries particularly pharmaceutical and semiconductor manufacturing now use on-line measurements due to the faster response, which is required for process control. Online TOC analysis comes with complete sample oxidation. Its complete regulatory compliance is USP <643>, <645>, and EP 2.2.44 and has wide dynamic range of 1 to 1,000 ppb. There is no requirement of reagents or chemicals. MeasureTest Corpora on - Mumbai - Maharashtra Tel: 022-2202 7982, Mob: 098690 12701 Email: measuretest@yahoo.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 July 2011 I Modern Pharmaceuticals

Product Index Sl No Product

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52

Pg No

Accelerated ageing test......................................... 57 Access control system............................................. 83 Acoustic enclosure.................................................. 47 Air filter ............................................................. 21, 23 Air shower controller ............................................. 83 Analytical instrument ............................................ 88 Analytical instrumentation ................................... 59 Antiallergics............................................................. 45 Automation software...............................Back Cover Axial flow fan.................................................... 84, 85 Biodiesel ................................................................ 57 Biological safety cabinet ................................... 21,23 Blow-fill seal machine.............................................. 9 Cardiovascular system......................................... 45 Central nervous system ......................................... 45 Centrifugal air blower............................................ 85 Chromatography system ....................................... 88 Clean room clock ................................................... 25 Clean room door............................................... 21,23 Clean room monitor.............................................. 25 COD analyser.......................................................... 49 Columns & chemistries ......................................... 59 Columns .................................................................. 88 Compositional & trace metal analysis ................. 57 Conical screw dryer.................................................. 5 Counters & power supplies.......Front Inside Cover Data logger................................................ 19, 25, 84 Diesel- fuel .............................................................. 57 Digital & GPS clock ............................................... 25 Digital differential pressure transmitter & indicator ................................................................ 25 Dispensing booth .............................................. 21,23 Door interlock system............................................ 83 Dry van pump ........................................................ 47 Duel fuel burner..................................................... 85 Elemental analysis................................................ 88 Empower ................................................................. 59 Encapsulated screw air compressor ..................... 84 Encoder........................................Front Inside Cover Exhibition - NDDS India - 2011............................ 6 Exhibition - Pharmac India - 2011........................ 8 Exhibitions - Engineering Expo - 2012............... 74 Failure analysis ..................................................... 57 Fan filter unit ..................................................... 21,23 Filler compositional analysis................................. 57 Fire alarm ................................................................ 83 Flame proof clock................................................... 25 Fluid bed dryer ................................................. 82, 85 Fuel........................................................................... 57 Gas detector .......................................................... 49 Gas generator .......................................................... 82 Gases ........................................................................ 57 Gear oil .................................................................... 57

Sl No Product

53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100

Pg No Sl No Product

Geared box .............................................................. 41 Geared motor.......................................................... 41 GMP heat exchanger................................................ 5 GMP reactor ............................................................. 5 Heart valve frame............................................ 29,35 HEPA filter terminal housing .......................... 21,23 Hot water generator............................................... 85 HPLC .................................................................. 59,88 Humidity & temperature transmitter.................. 25 Hydrogenator/autoclave........................................... 5 Ice flaker ................................................................ 82 Indirect air heater................................................... 85 Industrial chilling equipment ............................... 67 Industrial control & sensing device .........................................Front Inside Cover Industrial oven........................................................ 85 Informatics .............................................................. 59 Injectable manufacturing line.......................... 21,23 Inspection system ................................................... 13 Invertor/variable frequency drive ...........................................Front Inside Cover Laminar airflow workstation......................... 21,23 Level controller ...........................Front Inside Cover Lubes - engine oil................................................... 57 Mass spectroscopy system................................... 88 Material identificaton system................................ 57 Measuring & monitoring relay ...........................................Front Inside Cover Metallography system ............................................ 57 Molecular spectroscopy system ............................ 88 Motion control system...............Front Inside Cover Near-infrared spectrometer................................ 85 Online B2B marketplace ................................ 17,86 On-line TOC analyser............................................ 85 Pallet....................................................................... 85 Passbox................................................................ 21,23 Passbox inter-lock system...................................... 83 Petrol & fuel oil ...................................................... 57 Pharmaceutical labelling system........................... 68 Photoelectric sensor ...................Front Inside Cover Polymer characterisation....................................... 57 Pre-engineered & pre-fabricated modular panel ................................................................. 21,23 Process heat exchanger ............................................ 5 Process reactor .......................................................... 5 Programmable logic controller...................................Front Inside Cover Programmable terminal ............Front Inside Cover Proximity sensor.........................Front Inside Cover Pump........................................................................ 47 Quick change terminal hose.......................... 21,23 Rapid endotoxin detection system..................... 83 Return air riser................................................... 21,23

101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139

Pg No

RFID.............................................Front Inside Cover Roots blower ........................................................... 47 Rotary vacuum dryer............................................... 5 Rotocone dryer ......................................................... 5 Safe change housing........................................ 21,23 Safety light curtain .....................Front Inside Cover Sampling booth ................................................. 21,23 Self-adhesive tape ................................................... 40 SEZ developer ..................................Front Gate Fold Silicone carbide heat exchanger.............................. 5 Spectrophotometer................................................. 82 Spherical paddle chopper dryer ............................. 5 Steam boiler ............................................................ 85 Sterilising/ depyrogenating tunnel .................. 21,23 Switching relay............................Front Inside Cover Synchronised digital clock..................................... 25 Temperature & differential pressure indicator .............................................................. 25 Tempurature controller .............Front Inside Cover Testing system ......................................................... 57 Thermic fluid heater .............................................. 85 Thermoplastic valve & piping system .................. 7 Three parameter display........................................ 83 Timer............................................Front Inside Cover Transmission fluid.................................................. 57 Tray dryer ................................................................ 85 Tube boiler ...................................Back Inside Cover Turnkey project................................................... 5, 83 Twin - screw co-rotating extruder .................. 29,35 Twin - screw element........................................ 29,35 Twin - screw extruder....................................... 29,35 UHPLC .................................................................. 88 UPLC........................................................................ 59 Vaccuum booster pump ...................................... 47 Vaccuum system ..................................................... 47 Ventilator ................................................................. 40 Vial & bottle cap sealing machine........................ 83 Vibratory separator ................................................ 84 Vision sensor...............................Front Inside Cover Wireless clock ....................................................... 25

Looking for a speciďŹ c product? We will ďŹ nd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.

Modern Pharmaceuticals I July 2011

Advertisers’ List Advertiser’s Name & Contact Details

Pg No

Advertiser’s Name & Contact Details

Pg No

Advertiser’s Name & Contact Details

Ace Instruments T: +91-40-23078848, 32901226 E: sales@aceinstrumentshyd.com W: www.aceinstrumentshyd.com

IndiaMART InterMESH Limited

17, 86

Sreelakshmi Traders T: +91-44-24343343 E: sreelakshmitraders@gmail.com W: www.sreelakshmitraders.com

Aerotherm Systems Pvt Ltd T: +91-79-25890158 E: contact@aerothermsystems.com W: www.aerothermsystems.com

Avery Dennison India Pvt Ltd T: +91-124-2215581 E: lpm.in@ap.averydennison.com W: www.enhanceyourbrand.com Charles River T: +91-80-25588175 E: india.customercare@crl.com W: www.criver.com Dipesh Engineering Works T: +91-22-26743719 E: sales@dipeshengg.net W: www.dipeshengg.com

T: +1800-200-4444 / 91-120-3911000 E: pr@indiamart.com W: www.indiamart.com

Steer Engineering Pvt Ltd T: +91-80-23723309 E: info@steerworld.com W: www.steerworld.com

FIC

Testo India Pvt.Ltd. T: +91-20-65600203 E: info@testoindia.com W: www.testo.in

Thermo Fisher Scientific Sid Divisi T: +91-22-67429494 E: pradeep.kumar@thermofisher.com W: www.thermofisher.com

E: aparadkar@jbsez.com W: www.jbsez.com 68, 69

Omron Automation Pvt Ltd T: +91-80-40726400 E: in_enquiry@ap.omron.com

W: www.omron-ap.com Orbitz Exhibitions Pvt Ltd

T: +91-22-24102801 E: sanjeev@orbitzexhibitions.com 5

W: www.orbitzexhibitons.com Premium Transmission Ltd

T: +91-20-66314100 W: www.premiumtransmission.com 83

Engineering Expo T: +91-9819552270 E: engexpo@infomedia18.in W: www.engg-expo.com

Everest Blower Systems T: +91-11-45457777 E: info@everestblowers.com W: www.everestblowers.com

Salesworth Synergies Pvt Ltd (Seidenader) 13 T: +91-80-25274495 E: mail@salesworth.com W: www.seidenader.de Salesworth Synergies Pvt Ltd(Rommelag)

T: +91-80-25274495 E: mail@salesworth.com W: www.rommelag.com Shiva Analyticals (India) Limited

T: +91-80-27971322 E: gupta@shivatec-india.com 21, 23

W: www.shivatec-india.com Siemens Ltd

W: www.siemens.com/pharma

Gracure Pharmacuticals Ltd T: +91-11-47770900 E: Info@gracure.com W: www: gracure.com

IC ICE Make Refrigeration Pvt Ltd T: +91-2764-291022 E: icemake1@gmail.com W: www,icemakeindia.com

Sintex Industries Ltd

FGF

T: +91-22-66210000

Eltech Services Pvt Ltd T: +91-40-27759895 E: sales@eltechservices.com W: www.eltechservices.com

Fabtech Technologies Intl Pvt Ltd T: +91-22-61592900 E: mails@fabtecheng.com W: www.fabtecheng.ae

J B Sez Pvt Ltd

Pg No

29, 35

UBM India Private Limited T: +91-22-40461466 E: conferences-india@ubm.com W: www.ndds-india.com

Uniphos Envirotronic Pvt Ltd T: +91-22-6123500 E: singhrv@unipos.com W: www.uniphos-she.com

UNP Polyvalves India Pvt Ltd T: +91-265-2649248 E: mktg@polyvalve.com W: www.polyvalve.com

Waters (India) Private Limited T: +91-80-28371900 E: waters_india@waters.com W: www.waters.com

Yellow Pages

T: +91-2764-253500 E: sg-chakraborty@sintex.co.in W: www.sintex-plastics.com Spirax Marshall Pvt Ltd T: +91-20-27145595 E: response@forbesmarshall.com W: www.forbesmarshall.com

BIC

Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818. Our consistent advertisers

COMPLETE ENGINEERING UNDER ONE ROOF @ www.engg-expo.com

July 2011 I Modern Pharmaceuticals

Modern Pharmaceuticals

RNI No: MAHENG / 2008 / 27125 Postal Regd No: G / NMD / 122 / 2011 - 13 Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month Date Of Publication: 16th Of Every Month

July 2011