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Editorial
Partner‘ship’ sails
T
he rules of the game in the pharmaceutical space have certainly changed and how! In the span of only a few years the inbound as well as outbound trade dynamics have witnessed significant strategic manoeuvres including a few course corrections in some cases. This has not only shaped the global forays (which are still evolving) of Indian pharma companies but also affected the India-specific strategy of pharma MNCs.
The latest case in point is the reported preference of pharma MNCs to enter into alliances rather than outright acquisitions of their Indian counterparts. Considering the numbers of partnerships that have seen the light of the day in recent months, it seems a distinctly new order of doing business in India is under way from the perspective of international Big Pharma. So, what could be the trigger behind this shift in Indian strategy wherein most of the domestic companies have entered into an alliance to produce, sell or supply drugs within the country and abroad? Well, the primary reasons are both global and Indian. Let’s begin with the global factors. With a long pipeline of patent expiries as well as the humungous cost involved and high failure rates in developing new drugs, the partnership model of growth appears more attractive of late than the one based on acquisition. On the other hand, with the Indian pharma market getting increasingly regulated, there is immense scope for the Big Pharma to leverage the emerging opportunities by joining hands with Indian companies based on a win-win value-added approach. Along with sharing responsibilities, costs and benefits, such partnerships appear more appealing to MNCs in the backdrop of recent amendments in the government’s foreign direct investment policy.
Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE
Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories
Dr Gopakumar G Nair
That said, it is crucial to stay focussed on the priority action areas related to Indian healthcare needs in terms of accessible, affordable and adequate pharmaceuticals vis-à-vis the development of such collaborative models of growth. While it is good to bring down cost on a continuous basis (quality and safety being the given), ample prudence must be exercised by appropriate policy measures et al to ensure that the focus of R&D in such alliances stays in line with the primary disease areas rather than veering heavily towards niche areas.
IPR Consultant & Advisor
Dilip G Shah Chairman, IGPA & Secretary General, IPA
Daara Patel Secretary General, IDMA
Manas R Bastia manas@infomedia18.in
May 2012 I Modern Pharmaceuticals
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Contents
REGULAR SECTIONS 5
20
Editorial
69 Event List
10 News, Views & Analysis
71 Book Review
16 Technology & Innovation 72 Products
In Conversation With
18 Technology Transfer
84 List of Products
Harish Iyer Managing Director & CEO, Shantha Biotechnics Ltd
67 Projects
85 List of Advertisers
Special Focus
Automation Trends
Nutraceuticals................................. 23
Nutraceuticals market ..................................................... 24 Regulatory needs ............................................................ 26 Pricing strategies of nutraceuticals ................................... 30 Interface - V Bhasker Rao ................................................ 32
Robotics and lab automation for drug discovery When future becomes the present! .............................58 Bhanu Prakash, MD & CEO, Automed Systems Pvt Ltd
Energy Management Waste management No haste while disposing waste ..................................60
Roundtable ..................................................................... 34 Roundtable ..................................................................... 35
Policies & Regulations Impact of NPPA Draft 2011 Win some, lose some ..................................................62 Dr Ajit Dangi, President& CEO, Danssen Consulting
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Strategy Proximity dilemma To wish or not to wish? ..............................................64
Facility Visit Jubilant Life Sciences Ltd Banking on integration
Dr Rajan T D, Pharma Consultant & Practising Dermatologist
Tips & Tricks Insight & Outlook
Active Pharmaceutical Ingredients (APIs) ............... 39
Contract manufacturing API market ............................. 40
Pre-grant oppositions Knowing the nuances .................................................66 Kamakhya Srivastava, Head-Group on Research Publication and Programme, LEX ORBIS IP Practice
HP APIs for biogenerics ................................................. 42 Interface - Amitabha Gangopadhyay .............................. 44 Roundtable .................................................................... 46
Details on page no.: 61
Clinical research industry .............................................. 48 Influenza vaccines market............................................... 50
Highlights of Next Edition
Access to healthcare ....................................................... 52
Special Focus: R&D in Pharma Insight & Outlook : Pharma SEZ
Peristaltic pumps ........................................................... 54 Case Study - In-sight vision systems ............................... 56
Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise
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May 2012 I Modern Pharmaceuticals
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News,Views & Analysis Cipla announces a breakthrough price reduction on selected cancer drugs In keeping with its commitment to make medicines affordable and accessible particularly to cancer patients, Cipla Ltd recently announced a breakthrough price reduction in selected cancer drugs for the treatment of lung cancer; Hepatocellular Carcinoma (HCC), a form of liver cancer; Renal Cellular Carcinoma (RCC), a form of kidney cancer; and Glioma, a deadly form of brain cancer. Cipla’s brand ‘Soranib’ (Sorafenib) for the treatment of HCC & RCC will now be offered to cancer patients at a price of ` 6,840 for a month’s therapy. This comes as a boon for patients with a 76 per cent reduction from the current cost of ` 28,000.
According to World Health Organization (WHO), there are about 2.5 million cases of cancers diagnosed in India every year. Most cases receive suboptimal treatment due to the high cost of drugs. “This initiative of price reduction is a humanitarian approach by Cipla to support cancer patients” commented Dr Y K Hamied, Chairman and Managing Director, Cipla Ltd. He also added, “Drugs constitutes a significant proportion of the overall cost of cancer treatment and reduction in costs can greatly relieve the burden.” Cipla’ s Profit After Tax (PAT) increased by 36.3 per cent to ` 292 crore during Q4 FY11-12 as compared to ` 214
crore during Q4,FY10-11. The company’s domestic revenues grew by 15.5 per cent to ` 754 crore during Q4 FY11-12, up from ` 652 crore during Q4 FY10-11. The growth in domestic revenues were largely on account of growth in antiasthma, antibiotics, expectorants and antiinflammatory therapy segments. Exports of formulations grew by 15.1 per cent to ` 855 crore during Q4 FY11-12, up from ` 743 crore during Q4 FY10-11. Exports of APIs degrew by 1.0 per cent to ` 230 crore during Q4 FY11-12, from ` 232 crore during Q4 FY10-11. The growth in export revenues were primarily due to growth in anti-asthma and anti-malarial segments.
Glenmark Generics receives USFDA approval for lamotrigine tablets
Novozymes’ rAlbumin supports faster time to market for Neomend adhesion barrier sealant
Glenmark Generics Inc, USA the subsidiary of Glenmark Generics Ltd, has been granted final Abbreviated New Drug Approval (ANDA) from the United States Food and Drug Administration (US FDA) for lamotrigine 25, 100, 150 and 200 mg tablets, the generic version of Lamictal® by GlaxoSmithKline. Lamotrigine is an anti-epileptic drug indicated for epilepsy and bipolar disorder. According to IMS Health, sales data for the 12 month period ending
Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has recently announced that its recombinant human albumin (rAlbumin), Albucult®, is being used by Neomend in the company’s Progel® adhesion barrier sealant product that has recently received the European Union CE mark. David Renzi, President and CEO, Neomend, commented, “Novozymes
December 2011, lamotrigine tablets garnered annual sales of $ 62 million. Glenmark’s current portfolio consists of 80 products authorised for distribution in the US marketplace and 38 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
has an extensive understanding of the regulatory pressures its customers are facing and its quality-assured, consistent biopharmaceutical components make the company an ideal partner for Neomend. The Progel Adhesion Barrier Sealant CE mark is a vital milestone as it will enable us to help surgeons in Europe effectively prevent adhesions and its associated complications.”
Intertek India opens a new Extractable and Leachable (E&L) lab in Mumbai
Dr Guzzetti
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Intertek India recently announced the opening of its new analytical lab, specialised in conducting extractable and leachable studies in Mumbai. Dr Mara Guzzetti, Head, Operations - Chemical and Pharma Division, Asia Pacific, Intertek, inaugurated the lab with the vision to build a strong platform to provide extensive services to the pharma industry in India.
Investigation of materials that are coming into contact with pharmaceuticals and their possible interactions with these drugs are the basis of a better quality assurance for the packaging of the pharma products. Dr Guzzetti said, “With the increase in generics and contract manufacturing activities in countries like India and China, it is imperative to
have strong local expertise to look into quality at all levels, including medical devices. The new high-end testing facilities established by Intertek will enable our team of experts to conduct all the sophisticated analyses that need to be carried out on the ground in order to better protect the patients from related potential health risk.” - Chandreyee Bhaumik
Modern Pharmaceuticals I May 2012
News,Views & Analysis Mylan to partner with UN and CHAI Mylan Laboratories Ltd, the Indian subsidiary of Mylan Inc, recently announced that it has entered into a partnership with the UN’s Millennium Development Goals Health Alliance (MDGHA) and the Clinton Health Access Initiative (CHAI) to fight
childhood deaths caused by diarrhoea. At a recently conducted conference in Mumbai to discuss how public-private partnerships can be mobilised to advance the health of women and children in India, Mylan announced that
it would develop and expand access for needy children across the country. Anirudh Deshpande, Senior Vice President, Business Development, Mylan Laboratories in India, said, “This is a tragic, heartbreaking and avoidable situation that largely can be addressed if these children simply get the treatments they need. At Mylan, we are committed to increasing access to these affordable treatments to the children of India and those in the rest of the world. We share the concerns of organisations such as MDGHA and CHAI about expanding access to these life-saving medicines, and we look forward to continuing to work with them to help meet these needs.”
Granules India announces new Chief Financial Officer Granules India Ltd has appointed V V S Murthy as Chief Financial Officer Pranesh Raj Mathur, who had the dual role of President – Active Pharmaceutical Ingredient (API) Division and CFO will continue his role as the President of the API Division. Murthy previously served as Group Chief Financial Officer at Dishman Pharmaceuticals and Chemicals Ltd and has over 32 years of experience in the finance industry including 17 years in the pharma industry. “The addition of Murthy to the senior management team will ensure that we are able to move quickly and capitalise on new opportunities. His knowledge in optimising financial systems, working with foreign subsidiaries and M&A experience will be beneficial as our company continues to grow. Mathur who recently completed his EMBA at the Indian School of Business, will focus his energy on taking P&L responsibilities for our API Division,” said C Krishna Prasad, Managing Director, Granules.
Strides delivers robust Q1’12 performance Strides Arcolab recently announced its financial results for the quarter ended March 31, 2012. “The quarter’s strong operational performance in both specialties and pharma businesses reflect the company’s strongly articulated niche IP led strategy. The performance is driven by significant operating leverage and ramp up in capacity utilisation with continued regulatory approval momentum” said Arun Kumar, Vice Chairman & Group CEO, Strides Arcolab Ltd. The revenues excluding divested operations grew by 40 per cent to ` 495 crore (` 353 crore in Q1’11). And EBITDA excluding divested operations grew by 64 per cent to ` 137 crore (` 83 crore in Q1’11).
Dr Reddy’s announces the launch of olanzapine and quetiapine fumarate tablets Dr Reddy’s Laboratories has launched quetiapine fumarate tablets (25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg), a bioequivalent generic version of Seroquel® tablets in the US market following the approval by the US FDA of Dr Reddy’s ANDA for Quetiapine fumarate tablets. The Seroquwl® brand had US sales of approximately $ 4.6 billion for the most recent 12 months ending December 2011 according to IMS Health.
Besides, it has also launched olanzapine tablets, a bioequivalent generic version of Zyprexa® tablets in the US market on April 23, 2012 following the approval by the US FDA of Dr Reddy’s ANDA for Olanzapine tablets. Dr Reddy’s Olanzapine Tablets in 20 mg had been awarded a 180-day period of marketing exclusivity in the US on October 26, 2011 that was commercialised through a commercial, manufacture and supply agreement with Teva Pharmaceutical Industries Ltd.
Ranbaxy sales grow over 55 per cent with improvement in base business profitability The Board of Directors of Ranbaxy Laboratories Ltd at their recently held meeting took on record the unaudited results for the quarter ended March 31, 2012. The consolidated sales were ` 37,002 million and Earnings before Interest, Tax, Depreciation & Amortization (EBITDA) was 27 per cent of sales at ` 10,152 million. And, Profit After Tax (PAT) of ` 12,468
May 2012 I Modern Pharmaceuticals
million was registered. Commenting on the business results for the quarter, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “The focus on key products and markets,while maintaining emphasis on further strengthening quality and compliance standards has had a positive impact on the performance of Ranbaxy during the quarter. The company is working towards creating a sustainable, profitable,
growing business in the long run with differentiated, branded generics business at its base.” He added that an important development has been the resumption of exports to the US from the Indian facility. Sawhney highlighted, “Efforts are on to improve the effectiveness and efficiency of resource deployment continues, which is expected to result in further improving our base business in the coming quarters.”
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News,Views & Analysis Abbott announces collaboration with Syngene Abbott has recently announced its plans to establish its first nutrition R&D centre in the country in collaboration with Syngene. The Abbott Nutrition R&D Centre in India will focus on the development of science-based, affordable nutrition products for the country and enable the expansion of Abbott’s nutrition product portfolio there.
Abbott selected Syngene – a subsidiary of Biocon, the largest biotech company in India – to provide a science-based research and innovation team to work closely with Abbott researchers. More than 50 researchers and scientists will be based at the Abbott Nutrition R&D Centre in India at Biocon Park in Bengaluru, which is expected to open by June 2012.
The new R&D centre will focus on the development of nutrition products for maternal and child nutrition and diabetes care. Preventing undernutrition has emerged as one of the most critical health challenges in India. In addition, the centre will address local taste and texture preferences with new flavours and formulations.
Ranbaxy launches anti-malarial drug Synriam
Quintiles names Tom Pike as the new CEO
Ranbaxy has recently launched the drug Synriam, which it claims will prove a more efficient and simpler treatment for malaria. It is the first recently developed anti-malarial that is not based on artemisinin, one of the most effective treatments for malaria, which has begun to suffer from problems with resistance in recent years. Ranbaxy has hailed Synriam as India’s first domestically developed drug - although none of its active ingredients were discovered in the country. Ranbaxy developed Synriam as a fixed-dose combination of arterolane maleate and piperaquine phosphate, where arterolane is the New Chemical Entity (NCE) that was developed as an alternative to artemisinin. Synriam was produced as a combination therapy to follow
Quintiles has recently announced the appointment of Tom Pike as CEO. This appointment is part of the company’s long-term succession planning. Dennis Gillings, CBE, who founded the company, continues as Tom Pike Executive Chairman of its Board of Directors. Pike joined Quintiles on April 30, 2012. “Pike has an impressive track record of helping customers navigate fast-changing environments and solving complex business issues,” Gillings said. “He has experience with organisations our size and much larger that will be extremely valuable to us. Pike has a disciplined and forthright approach that will enable him to earn the trust of customers and employees alike. I am confident he will soon make his mark on our company and the industry at large, continuing the Quintiles tradition of entrepreneurial leadership and pioneering growth.”
World Health Organization (WHO) guidelines on delaying the appearance of drug resistance. In clinical trials, Ranbaxy reported a cure rate of 95 per cent when three tablets were taken over the course of three days - a simpler drug regimen than other treatments. According to the WHO, 225 million new malaria cases are reported each year, resulting in more than 650,000 deaths. Most occur in developing countries. With that in mind, arterolane was developed with the goal of creating a drug whose synthesis can be scaled up simply to help keep costs down. By contrast, artemisinin is still produced from plant sources, making it expensive. Arterolane’s simple synthesis process means that it can be sold at less than $3 (£1.85) a course.
Ella Foundation receives $ 100,000 grant to checkmate polio and block VDPV
Novozymes starts commercial supply of new and improved hyaluronic acid
Ella Foundation recently announced that it has won $ 100,000 Grand Challenges Explorations (GCE) Grant. This project to ‘checkmate the polio virus’ during and after the eradication of poliomyelitis could result in a live polio vaccine that cannot perpetuate. Such a vaccine could carry the beneficial effects of an oral polio vaccine namely safety, efficacy, ease of manufacture, distribution
Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, has announced the first shipment of the company’s Bacillusderived hyaluronic acid, Hyasis®, from its newly inaugurated manufacturing facility in China. The first commercial products using Hyasis as a raw material are expected to reach the market in Q2 of this year. “Shipment of the first commercial hyaluronic acid material from our new Q7 GMP facility marks an
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and administration along with the safety profile of an injectable polio vaccine by eliminating VaccineDerived Polio Virus (VDPV ). “GCE encourages individuals worldwide to expand the pipeline of ideas where creative, unorthodox thinking is most urgently needed,” said Chris Wilson, Director, Global Health Discovery and Translational Sciences, Bill & Melinda Gates Foundation.
important milestone on our journey to becoming a leading producer of high quality hyaluronic acid. With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA, which is fully compliant with the highest pharmaceutical standards and developed with customers’ specific needs in mind”, said Thomas Videbæk, Executive Vice President, Novozymes A/S.
Modern Pharmaceuticals I May 2012
News,Views & Analysis Bosch to demonstrate new turnkey packaging solution for powders At Achema 2012 in Germany, Bosch Packaging Technology will exhibit its new packaging system that integrates a stick pack machine and a flow wrapping machine. A seamless interface between the primary and secondary packaging machines maintains output quality, helps to eliminate downtime and ensures the system provides optimal performance. The
system is suitable for handling of a wide range of granules, powders and pellets, particularly for the pharmaceutical industry and is designed to provide highly accurate dosing via sophisticated filling augers. Frank Bühler, Product Manager, Bosch Packaging Technology, said, “We are seeing growing demand for Stick Packs due to the convenience, minimal material
requirements and easy and safe opening of this pack style. The combination of the Sigpack RA and HCM machines in this packaging system allows manufacturers to bring this pack style to market efficiently and safely. It ensures precise dosing at high cycle speeds and we are pleased to have the opportunity to present it to pharmaceutical manufacturers at Achema in June.”
Dr Deven Parmar joins Karmic Lifesciences Inc as CEO & Medical Director, Americas
Neurobiologix launches new calming cream to assist with relaxation and healthy rest
Dr Deven V Parmar, one of the most eminent personalities from the industry has joined Karmic Lifesciences Inc as CEO & Medical Director, Americas. He comes in with over 8 years academic experience Dr Parmar and about 20 years of rich professional experience in the pharma and clinical research industry. His illustrious career includes stints with Wockhardt Ltd, Veeda Clinical Research, GlaxoSmithKline, Ranbaxy and Serdia Pharmaceuticals. His areas of expertise include clinical research, data management, medical writing & statistics, pharmacovigilance, regulatory and due diligence, licensing, business development & co-development. Karmic Lifesciences Inc is delighted to have Dr Parmar head activities in the US. Based out of New Jersey, his responsibilities would include handling all strategic, business and scientific activities for the US subsidiary.
Neurobiologix, has announced the launch of its presecription product Calming Cream, a new topical cream that is designed to naturally assist with nervousness, hyper-activity, mood, sleep disturbances and trouble falling asleep. By delivering five active ingredients through the skin in a lotion base of lavender oil, Calming Cream increases the levels of calming and anxiety-
reducing neurotransmitters in the brain such as dopamine and serotonin. “Whenever the brain is not producing enough of the natural chemicals that inhibit stress and nervousness, the likelihood of experiencing difficulty with relaxation, mood instability, sleep and stress is very high,” said Dr Kendal Stewart, MD, Neurobiologix.
FDASmart concludes its second anti-counterfeiting conference FDASmart, held its ‘2nd Pharmaceutical AntiCounterfeiting Conference in Emerging Regions.’ The theme for the forum was to acknowledge the serious threat of counterfeits and trace a multistake holder look at the progress made in winning the battle against
counterfeits. A world-class group of experts came together to drive home not only the problems but present innovative solutions to win the war against counterfeiters. Panel discussion at the end of the session involved some provocative discussion that included the audience comments and feedback.
AstraZeneca and DNDi to collaborate on drug screening for neglected tropical diseases AstraZeneca and the Drugs for Neglected Diseases initiative (DNDi) have announced an agreement to collaborate on drug-compound screening for leishmaniasis, Chagas disease, and sleeping sickness, three Neglected Tropical Diseases (NTDs) that together affect nearly 10 million people worldwide. Novel drug candidates to emerge from this collaboration will bolster the drug development pipeline for new medicines urgently needed by millions of patients. In the
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new partnership, AstraZeneca will provide to DNDi 15,000 compounds that have the potential for activity against leishmaniasis, Chagas disease, and sleeping sickness. The screening activities, coordinated by DNDi, will be performed at Institut Pasteur Korea (IPK). If active compounds against any of the three diseases are identified as ‘hits’,DNDi and AstraZeneca will jointly assess their potential as starting points for future medicines. “As a global pharma company that
conducts a significant amount of infectious disease research, AstraZeneca recognises the urgent need to deliver new medicines for people who suffer from neglected tropical diseases. Sharing science beyond our own labs with leading organisations like DNDi is a great way to tackle these complex diseases that have gone unchecked for far too long”, said Manos Perros, Head Infection Innovative Medicines Unit, AstraZeneca.
Modern Pharmaceuticals I May 2012
News,Views & Analysis Waters brings award-winning UltraPerformance Convergence Chromatography to Analytics 2012 Waters Corporation is exhibiting its award-winning ACQUITY UPC2 System for the first time in Europe at the 23rd Analytical International Trade Fair for Laboratory Technology. The ACQUITY UPC2 System is a new category of separations science instrumentation that gives laboratories previously unavailable options for tackling tough analytical
challenges. “The introductions we are bringing to Analytical reflect strong customer demand for greater problemsolving capability, greater efficiency and certifiable data quality. UPC2, NuGenesis 8 and our new line of analytical standards and reagents make this year’s Analytical one of the most exciting in years for us,” said Art Caputo, President, Waters
Orchid Pharma receives US FDA approval for naratriptan tablets The Chennai-based global pharma major Orchid Chemicals & Pharmaceuticals Ltd has received approval from US FDA for its Abbreviated New Drug Application (ANDA) for naratriptan tablets in the 1 mg and 2.5 mg strengths. Naratriptan tablets are the generic equivalent of GSK’s Amerge tablets. Orchid Chemicals is a leading pharmaceutical company engaged in the development, manufacture and marketing of diverse bulk actives, formulations and nutraceuticals.
Abbott and GVMC partner to screen women in Vishakhapatnam for thyroid disorders Abbott and Greater Vishakhapatnam Municipal Corporation (GVMC) recently signed an agreement to provide diagnosis and expand access to care for thyroid disorders, to help improve the quality of life of women in Vishakhapatnam. This partnership is one of the first-of-its-kind in the country that is initiated by a government body and will screen approximately eight lakh women from Vishakhapatnam over a period of three years. While GVMC provides the infrastructure, Abbott provides GVMC with subsidised diagnostics and educational materials. Abbott also will support the Indian Thyroid Society to provide advanced courses on the management of thyroid disorders for the medical officers of GVMC. The patients would be treated at the Department of Endocrinology, King George Hospital in Vishakhapatnam.
Japan chooses Sanofi Pasteur for first enhanced inactivated polio vaccine Sanofi Pasteur, the vaccines division of Sanofi, recently announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the company’s standalone Inactivated Poliovirus Vaccine (IPV) against acute flaccid poliomyelitis (Imovax® Polio). Imovax® Polio will be added to the country’s public immunisation programme on September 1. The approval of Imovax® Polio by Japanese health authorities is a major milestone towards a polio-free world. Imovax® Polio is an inactivated poliovirus vaccine made from poliovirus types 1, 2 and 3. Since its launch in France in 1982, Imovax®Polio has been approved in 86 countries.
May 2012 I Modern Pharmaceuticals
Division. Adding to this Harbaksh Sidhu, Program Director - ACQUITY UPC2 Program, Waters Division said, “With ACQUITY UPC2 we applied our expertise in ultraperformance chromatography to the traditional technique of SFC and emerged with a more universal laboratory tool with much broader applications.”
Quintile wins Best CRO in Vaccine Excellence Awards Quintiles announced that it has been named the Best Clinical Research Organization (CRO) in the Vaccine Industry Excellence (ViE) Awards 2012. Presented at the World Vaccine Congress now under way in Washington, DC, the awards recognise and celebrate the leaders, innovators and pioneers in the vaccines industry. “This is a great honour to be recognised as the Best CRO at the World Vaccine Congress,” said Dr Ellen Vigdorth, VP Allergy, Respiratory, Infectious Diseases and Vaccines.” Adding to this he said, “It is a huge achievement and underscores our commitment to the development of quality vaccines and anti-infective products.” This award comes shortly after Quintiles was named for the second year running, the 2012 Asia Pacific CRO of the Year at the BioPharma Convention Awards.
GlaxoSmithKline Pharmaceuticals observes World Asthma Day On the occasion of World Asthma Day, GlaxoSmithKline Pharmaceuticals Ltd (GSK) organised asthma check-up camps. These camps were held in around 20 cities across the country. The ‘Asthma check-up’ camps were conducted by respiratory specialty doctors as an endeavour toward creating asthma awareness and received tremendous response across the country. Research shows that asthma runs in families. However, environmental factors also contribute. Many substances can aggravate allergies or increase the
severity of asthma symptoms in individuals who are sensitive to these allergens or irritants. Some of the most common seasonal and non-seasonal allergens and asthma irritants are - cigarette smoke, cockroaches, dust mites, mold, pets & animals, pollen. Asthma requires long-term care and monitoring. It cannot be cured, but it can be controlled. Asthma management requires recognition and monitoring of symptoms, lifestyle modifications, environmental changes, adherence to treatment and medication plans.
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Technology & Innovation Merck Millipore launches Mobius® CellReady 50 L single-use stirred tank bioreactor
Malvern introduces mastersizer micro
Merck Millipore recently expanded the Mobius® CellReady bioreactor portfolio with the launch of a 50 L single-use stirred tank bioreactor for process development and pilot scale mammalian cell culture. This new bioreactor allows biopharma manufacturers to implement robust, singleuse technologies that bring their drugs to market faster, with less risk. “The Mobius® CellReady 50 L bioreactor is an important addition to the Mobius® family. We have integrated a number of innovative features that deliver ease of use, reliability and operational flexibility compared to existing single-use systems,” said Paul Chapman, Vice President, Biopharm Process Solutions. The Mobius® CellReady 50 L bioreactor extends the company’s portfolio of single-use processing systems from cell culture through ultrafiltration/diafiltration.
Cognex sets a new standard for industrial OCR Cognex Corporation has recently introduced OCRMax™, a new tool for Optical Character Recognition (OCR) and Verification (OCV ) applications that gives Cognex vision systems and vision software the power to achieve the highest read rates while keeping misreads to a minimum. OCRMax is fast, OCRMax easy to set up and simple to use across all In-Sight® vision system and VisionPro® vision software platforms. OCRMax overcomes the limitations of other OCR technologies. It is an all-in-one tool that can handle character variations, text skew, proportional fonts and variable string lengths, making it the most robust character recognition tool in the industry. OCRMax is easy to set up and use, with minimal training being required. The key to achieving the highest read rates with OCRMax is its superior character segmentation capability. The segmenting functionality takes each character line and splits it into individual regions that each contains one character. This robust functionality ensures that OCRMax can handle distorted, touching and variably spaced characters.
Mastersizer
The Mastersizer micro particle size analyser was developed to provide a simple-to-use compact particle analysis solution capable of being operated at or near the production line as well as in the laboratory. Sample handling and dispersion is simplified by the use of standard 600 to 1000 ml laboratory beakers in place of a fixed tank. Its robust construction and relatively small size have made the micro very popular for off shore and mineral exploration applications. Dip-in pump and stir head with continuously variable single shaft pump and stirrer and continuously variable ultrasonic probe. The spring counterbalanced stir head is lowered into a standard 600 ml to 1000 ml laboratory beaker in which the sample is dispersed. It helps in measuring materials from 0.3 μm to 300 μm.
Singapore scientists discover ‘switch’ to boost body’s immune response Singapore scientists from Bioprocessing Technology Institute (BTI) under the Agency of Science, Technology and Research (A*STAR) have for the first time, identified the molecular ‘switch’ that directly triggers the body’s first line of defence against pathogens, more accurately known as the body’s ‘innate immunity.’ The scientists found that this ‘switch’ called Bruton’s Tyrosine Kinase
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(BTK) when turned on, activates the production of interferons - a potent class of virus killers that enables the body to fight harmful pathogens such as dengue and influenza viruses. This discovery of BTK’s role as a critical ‘switch’ that boosts the body’s anti-viral response, paves the way for developing anti-viral drugs that target the BTK ‘switch’ to fight infectious diseases.
The research team from BTI extracted a class of innate immune cells known as macrophages3 and challenged them with the dengue virus. They found that the BTK-deficient immune cells were unable to produce interferons, and hence had much higher viral counts compared to the healthy immune cells that had high-levels of interferons to fight the virus effectively.
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Technology & Innovation New imaging system from Thermo Fisher Scientific for life science applications Thermo Fisher Scientific Inc has recently featured the new Thermo Scientific myECL Imager. It revolutionises the capture and analysis of stained protein gels and nucleic acid gels by simplifying the entire imaging workflow. myECL Imager incorporates advanced Charge-
myECL
Coupled Device (CCD) technology that results in greater sensitivity of X-ray film, with a significantly higher dynamic range. The intuitive touch screen controls with on-board computer simplify the image acquisition process while improved sensitivity and small instrument footprint make the myECL Imager an
RFID technology improves product quality for diverse pharma applications Today, fast-paced pharma manufacturing and processing environments rely on high precision performance in order to ensure consistent product identification, monitoring and tracking. Further, these products must be verified to be of the highest quality—from manufacturing to delivery. In the past, barcode technology was commonly used to monitor and track these processes, providing users with reliable product information to ensure quality and consistency. Due to recent technological advancements, manufacturers are moving towards the use of a more sophisticated solution, Radio Frequency Identification (RFID), to track and trace products. By gathering more data through tags or transceivers, RFID allows users to read the authenticity onto the tag and write them to a data carrier. Further, RFID systems offer diverse I/O capabilities for superior communication and connectivity—allowing for maximum performance. Data carriers can also provide a high quantity of read or write operations with high speeds, ultimately increasing tracking capabilities to improve operations.
Vicam’s new Fumo-V Strip tests delivers accurate detection of fumonisin mycotoxins Waters Corporation has recently announced that Vicam® - a Waters® Business, has introduced the Fumo-V™ strip test, the newest member of its quantitative strip test family. “Fumo-V strip tests make testing for mycotoxins more accessible to food and agriculture producers worldwide. They rely on early detection to protect humans and animals from potentially lethal effects of contamination,” commented Marjorie Radlo, General Manager - Director of Operations, Vicam. “Our quantitative strip tests can easily be performed onsite or in the laboratory giving precise, numerical results.” “The Fumo-V test is well-suited to onsite locations. Users do not need to be chemists and can learn to use the test in less than 30 minutes, yet still obtain quantitative results,” said Dr Stephen Powers, Head Research & Development, Vicam.
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effective substitute for the laboratory darkroom. The Thermo Scientific myImage analysis software supplied with the instrument provides a suite of programmes to analyse nucleic acid or protein images, including automatic lane and band identification and molecular weight overlay analysis programmes. The myImage analysis software saves image files in a non-proprietary format for easy sharing with colleagues.
PerkinElmer’s Next Generation sequencing solutions PerkinElmer, Inc has signed an agreement to provide Next Generation Sequencing (NGS) sample preparation solutions to Macrogen, Inc a Korean-based global sequencing company. As part of the agreement, PerkinElmer will provide Macrogen with its Sciclone® NGS Workstation for high throughput automated next generation sequencing sample preparation, the LabChip® XT nucleic acid size selection and collection system, and the LabChip® GX nucleic acid separation system, to automate and increase the company’s sequencing analysis efficiency and throughput. “We are delighted to assist Macrogen in its global mission to help realise the promise of understanding the human genome through its services, to advance better therapeutics and diagnostics for clinicians and patients worldwide,” said Kevin Hrusovsky, President, Life Sciences & Technology, PerkinElmer. “Our next generation sequencing solutions are well suited for helping to ensure the quality and integrity of genomic information for use in making personalised medicine.
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Technology Transfer 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.
Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,l’-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing 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 Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Urease on its one end and to a voltage measuring
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device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing 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 Formulation for leucoderma It is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application Pharma and medical industry Transfer terms Joint Venture, technology licensing, research partnerships
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 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. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Process of preparation of nanoparticles for drug delivery system The present invention is related to a process for the preparation of the novel nanoparticles of apotransferrin or transferrin which are useful for the preparation of a pharmaceutical composition facilitating easy delivery of the drug. Areas of application Medical and pharma industry Forms of transfer Technology licensing Pharmaceutical composition for the treatment of ophthalmic disease A company can offer technology for manufacturing a drug useful in the treatment of opthalmic disorders. A composition comprising Lithium chloride is the product which causes retinal cell regeneration. Lithium chloride alone helped in proliferation of retinal cells but is associated with other effects. Areas of application Pharma and medical industry Transfer terms Consultancy, technical services, technology licensing
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Technology Transfer
Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D 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. Areas of application Biotechnology, engineering Forms of transfer Consultancy Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others
Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. Areas of application Medical research Transfer terms Others Manufacture of intravenous fluids A company requires know how and technological requirements for the manufacture of intravenous fluids. Know how should include where to obtain appropriate grade raw materials. Areas of application
Pharma/medical Forms of transfer Others
Extract of medicinal and aromatic plants A 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
Manufacturing technology of hepatits B, tetanus, diphtheria and pertussis vaccines An Indian company is interested in a complete technology for start up of manufacturing of combination vaccines from bulk to formulations including supply of protocols for manufacturing and production strains. Areas of application Human vaccines Transfer terms Others
IV fluid manufacturing as SME An Indian company needs new and good technology to start manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others
Manufacturing of liquid bio fertilisers An agro biotech company is looking for a proven technology for manufacturing of liquid bio fertilisers. They would like to know the kind of technology that could be offered (ie the product, efficacy, length of field trial) and a procedure of buying the technology along with the cost incurred.
Areas of application Biotechnology Transfer terms Others Manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid, D-biotin A company needs API/bulk drug manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid and D-biotin Areas of application API/bulk drug Forms of transfer Others Pharma grade mannitol know-how A company is on the look out for a commercially proven latest technology & know how (turnkey) for manufacturing pharma grade mannitol in India. The estimated production capacity is 600 tonnes per annum. Areas of application Pharmaceuticals Forms of transfer Others Pharmaceutical Lyophilisation plant A Peru based company is looking for a Lyophilisation plant for pharmaceutical use. Capacity shall be around 175 to 200 square feet, for the lyophilisation of 20,000 vials of 10 mL per day. Areas of application Pharma and food processing 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.
Share and Solicit Technology The mission of Modern Pharmaceuticals is to spread the technology culture. Here is an opportunity to be a part of this endeavour by sending your technology on offer or technology requirements. If you belong to any of these two categories, you are invited to furnish the techno-commercial details for publication. The write-up needs to be as per the format of this section with information about the particular technology offered or requested, its areas of application and forms of transfer. Contact us: Modern Pharmaceuticals, Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4695 Fax: 022-3003 4499 Email: spedit@infomedia18.in
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In Conversation With: Harish Iyer
“At Shantha, our focus is to provide accessible and affordable healthcare”
Jasleen Kaur Batra …says Harish Iyer, Managing Director & CEO, Shantha Biotechnics Ltd. A graduate in Chemical Engineering from the Indian Institute of Technology, Chennai, he subsequently obtained his PhD in Chemical Engineering from Rensselaer Polytechnic, New York. He has over 15 years of experience in the field of biotechnology and biopharmaceutical R&D and has worked with companies such as Genentech, IDEC Pharmaceuticals Corp and Biocon. Excerpts...
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Modern Pharmaceuticals I May 2012
Harish Iyer After joining Shantha what have been your areas of focus? Today, Shantha is at an interesting position. We have had several changes in the senior management team last year and so today we have a new team and a new identity. It is an exciting new phase in many ways. After coming to Shantha our focus as a company is to provide accessible and affordable healthcare. The most exciting news this year from the public health point of view was that India has no reported cases of polio and the end game of polio will be Inactivated Poliovirus Vaccine (IPV). So there are two things we are trying to do - one is look at IPV and how we can supply this to the market through Shantha, and also globally can we be a source of IPV. Our focus will also be on looking at IPV in terms of hexavalent packaging. Apart from this, we have an interesting R&D pipeline - we have rotavirus, which kills up to a 100 thousand infants in India alone and globally 5,00,000. This vaccine is in the clinical stage at the moment. We are also looking at long term R&D of Human Papilloma Virus (HPV ) vaccine that will go under clinical trial towards the end of this year or early next year. Also, Shantha is primarily about supplying to the government - the public market of India. This year we are supplying considerable amount of vaccines to the government and we wish to do that in the future as well. We have WHO pre-qualified vaccines, which we supply to the government. From our perspective, it is the responsibility of the government to deliver quality healthcare to the rural parts of India. It is hard for us to invest a huge amount of capital in the supply chain and we wish that the Indian government does this. What are the critical areas while dealing with vaccines? Vaccines are complex models and so they need strict control on acid and raw materials coming in which can cause variability in the quality of the vaccine. We need to monitor all these components carefully and the manufacturing process has to be controlled as well. Another
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important aspect is that of people. If people in the organisation are not trained to look at the right things there is a problem. Hence, it is important to have right checks and balance all across the company as the procedure of manufacturing vaccines and ensuring high quality is an extremely complex process. At Shantha, we give considerable importance to all these factors and are also looking at investing in training people, knowing what to look for and better production of vaccine to ensure that even before we go into production we are assured that the product would not fail.
in early stages of research. Another novel vaccine that is in the pipeline is Human Papilloma Virus (HPV ) vaccine associated with the prevention of cervical cancer. Hepatitis B and rotavirus are a few more vaccines in the clinical stage. It is also possible that we start manufacturing the vaccine for measles such that it can be made more affordable and accessible to the Indian market. We are expecting to launch rotavirus vaccine in India by 2015. We are in the early phase of clinical trials and have already finished one set of trials and would be entering phase II very soon.
What is your take on the vaccine policy of India? We do not have a strong vaccine policy in India. For instance, the tender system in India is not like that of the UNICEF. There is no understanding of the
What quality standards are maintained by Shantha? At Shantha our main goal is to get all our vaccines certified by the World Health Organization (WHO). Today, the standards of WHO have also increased tremendously. WHO certainly expects higher standards from vaccines and other drug manufacturing companies. Hence, we ensure that all our products are WHO qualified.
It is the responsibility of the government to deliver quality healthcare to the rural parts of India and we wish that the Indian government does this.
five-year time frame or three-year time frame. Even today, we use the same vaccines that were being used before and have not really expanded like other countries. There are new vaccines that can be brought in India such as the rotavirus and IPV. Also, the procurement mechanism and supply mechanism needs to be changed. Today, we need to have a more robust dialogue with the government on how to have more predictability. How does Shantha’s vaccines pipeline look like? Presently, we have hexavalent and a typhoid conjugate vaccine that are
Please quantify the investments made by Shantha for healthcare every year for the Indian market. It is extremely important that one makes regular investments in the company to upgrade their machinery as well as acquire the latest technology available. Today, we are making investment in equipment as well as upgrading our facility. We are also looking at various ways in which we can supply our vaccines to the global market, so we are investing a lot in research as well. Hence, if we put together all these areas of investment, we invest approximately $ 300 million annually on India alone. What are your expansion plans? We are in the process of setting up a facility 5 km away from our current facility, which would be used for manufacturing Shan 5, Shan 6, rotavirus and other vaccines, which should be ready by 2014. This new facility will also help us fulfill our dream of manufacturing a billion doses of antigen globally in 2015. (jasleen.batra@infomedia18.in)
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Special Focus
Nutraceuticals Nutraceuticals market Under the scanner ................................................................24 Regulatory needs Why amendements are a must? .............................................26 Pricing strategies of nutraceuticals Aiming towards extended affordability ..................................30 Interface V Bhasker Rao MD, Nandan Biomatrix Ltd ......................................................32 Roundtable Will an Act like the Drugs Prices Control Order (DPCO) help?............................................................34 Are Indian pharma companies investing enough in nutraceuticals? .................................................................35
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Special Focus: Nutraceuticals market
the
scanner
With time people are gradually comprehending that nutraceuticals help not only for well-being but also for therapeutic purposes, and with this realisation, the Indian nutraceuticals market is growing. Chandreyee Bhaumik
T
he healthcare industry in India is showing great progress. With the passage of time there has been considerable increase in spending on healthcare backed by an increase in the purchasing power of individuals. Moreover, a lot of significance is being given to preventive medication,
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and in this scenario the nutraceutical segment in India is all set to flourish. Today, the nutraceuticals market is one of the booming markets in India. According to a research report from Freedonia, the global nutraceuticals ingredients market is forecasted to record yearly growth in excess of 7 per cent to reach almost $ 24 billion by 2015. Growth will come from ingredients
with clinically confirmed health benefits that can be used in a wide range of dietary supplements, drinks, foods and nutritional preparations for children and adults. Additionally, market growth across developing nations is expected to be faster in terms of consumption and production compared with developed nations. Nutraceuticals are used in the prevention of potential diseases and the healing of already existing ones. Nutraceuticals can be broadly defined as nutrients that include substances, which have their nutritional functions eg, vitamins, minerals, amino acids, fatty acids, and so on; herbs or botanical products; and the third category is dietary supplements such as probiotics, prebiotics, antioxidants and enzymes. However, most common nutrients supplemented as nutraceuticals are minerals and vitamins, or in combination and or with other antioxidants. And the Indian nutraceutical market is dominated primarily by the Fast Moving Consumer Goods (FMCG) and pharmaceutical industry.
Growth prospect According to Transparency Research, the nutraceuticals product industry is classified broadly according to functional beverages, functional food and dietary supplements. And market growth is fuelled by dietary supplement segment expansion. The protein and peptides sector of the dietary supplement market is expected to record strong growth in the coming years. In addition to this, the non-herbal market segment of the dietary supplement sector is also forecast to record strong growth between 2012 and 2017. Further, the report also shows that the Asia Pacific nutraceutical product market is an emerging market in dietary supplements and functional food segment. Japan is stated to be the largest consumer of nutraceuticals. Also, the report shows that China is the second largest consumer of nutraceutical product as people are more conscious about their food habits and they have the largest population in the world. The functional food market in India is
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Nutraceuticals market There is a huge unmet demand in the market in the area of preventive healthcare. We would be introducing need-based clinically researched nutraceuticals products in order to cater to this huge requirement. Rajesh Kumar CEO, SamiDirect
expected to have moderate growing rate as compared to dietary supplement in the region. The functional food and beverage market in India is expected to have a 70.74 per cent rise as compared to the dietary supplement in 2017. Predominantly, vitamins and minerals derived from oral pills were used for curing certain diseases and ailments. However, as people are gradually becoming health conscious they are becoming prone to consume immunity-enhancing food supplements and wellness-related products. This is promoting the growth of the industry with players diversifying into production of various new varieties of products. Additionally, assistance from the government and the increasing demand from consumers will fuel growth in this market. Factors like increasing shift towards preventive therapies,increase in the disposable income, increase in healthcare spending, increasing shift towards self-medication, changing demographics along with the growth in pharmacy and wellness-related retail chains and favourable pricing environment have resulted in the growth of the nutraceutical market. Commenting on the market growth, Rajesh Kumar, CEO, SamiDirect, says, “The nutraceuticals market in India is growing at 25 per cent Compounded Annual Growth Rate (CAGR) every year.” Further, comparing the Indian market scenario with the US, Kumar avers, “The US market is more regulated since it evolved in the early 70s. The average growth is only 5 per cent per annum. Also, Dietary Supplement Health and Education Act (DSHEA) is undergoing many regulatory changes,
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We should also remember that the nutraceuticals do not have side-effects because the molecules are made of either plants or herbs. Ritesh Chordia Vice President - Sales and Marketing, Bioprex Labs
which also is affecting the slow growth in the US.”
Meeting the demand India is going to be a major market for nutraceuticals in the future. Discussing the growth strategies, Kumar reiterates, “There is a huge unmet demand in the market in the area of preventive health care. We would be introducing needbased clinically researched nutraceuticals products in order to cater to this huge requirement. Additionally, we are planning to set up a call centre for products in different languages. This will essentially help us to connect with people.” Again, he believes that in this way a company will be able to penetrate to remote regions within the country in a systematic way. Elaborating on the nutraceuticals market, Ritesh Chordia, Vice President - Sales and Marketing, Bioprex Labs, discusses, “With time we can easily discern the huge scope for nutraceutical market. Fortunately, today doctors are able to understand the benefits of nutraceuticals. Further, with time, people now realise that nutraceuticals are not only required for their wellbeing but also for therapeutic purposes. Thus, various companies are marketing vigorously in this regard.” In order to cater to the growing demands of the market the companies should study the demand pattern and then customise their products accordingly. For nutraceutical segment, proper validation process is required to be conducted.
Roadblocks Several trends such as fortified foods,
ayurvedic nutraceuticals, foreign tieups, players educating consumers, encapsulation are seen. However, in spite of the prosperity there are several challenges that the Indian nutraceutical market is facing. The key challenges to the market include lack of standardisation, marketing and distribution challenges, high pricing and lack of awareness. Elaborating on the challenges in this market, Kumar says, “Unfortunately, the approach in the market was more of curative one as of now. Initially, wellness was all about treating illness but we intend to bring a paradigm shift in the approach of wellness. We want to convey that we do not need nutraceuticals when someone is getting ill or delaying the onset of illness.” He further adds, “The biggest challenge is to reach out to people with the correct information. This context we are addressing with our direct client approach. Additionally, we are also working on the call centre concept.” Elaborating on the level of awareness as far as nutraceutcials market is concerned, Chordia explains, “With time, people are getting aware about nutraceuticals. Fortunately, in today’s world the young generation has access to the Internet but the traditional people still have a different mindset. They prefer having the apple instead of the antioxidant Apple. We should also remember that the nutraceuticals do not have side-effects because the molecules are made of either plants or herbs.” Thus, the nutraceuticals market demonstrates an exciting market dynamics with huge growth potential. (chandreyee.bhaumik@infomedia18.in)
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Special Focus: Regulatory needs
Why amendements are a must? With too many nutraceutical players mushrooming regularly there is a need for a strict and clear & defined regulatory system. Lack of clarity in this regard will merely add to the woes.
Primarily due to the growing health consciousness among consumers over preventive measures for diseases,this market is being fuelled with growth potential. Further, some nutraceutical companies have discovered India as an incredible R&D resource, stemming from the large and mature generic pharma industry that already exists there. Additionally, Indian research and technology in areas of fermentation processes, plant extraction and even chemical synthesis are generally much more developed compared to their Chinese counterparts and continue to have labour cost savings that make outsourcing attractive.
Present regulatory scenario
Illustration: Sachin Bhogate
Chandreyee Bhaumik
T
oday, nutraceuticals is one of the booming markets in India. According to various reports, the total market for nutraceuticals in India was valued at ` 44 billion in 2009 and is expected to reach ` 95 billion in 2013. Further, the US has been the major market for nutraceuticals with India and China becoming fastest growing markets. Today, nutraceuticals are gaining acceptance due to their ability to address several diseases. Vitamins, minerals and nutrients constitute about 85 per cent of the market, while antioxidants and antiagents account for 10 per cent of other segments such as herbal extracts occupy 5 per cent of the market, globally. Even today India does not have any strictly defined guidelines or regulations for the nutraceutical segment. In an
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endeavour to receive global acceptance, Indian Government has taken several initiatives for laying down science-based standards for articles of food and to regulate their manufacture, distribution, sale and import, etc. Nutraceuticals are not a part of pharma and drugs formulation. Thus, rules and regulations also tend to be different for this segment. Therefore, in order to bring a sort of decorum in the scenario Indian government had introduced Food Safety and Standards Authority of India (FSSAI). However, this could not completely do away with the confusion that the players had. Further, the new entrants were not too sure about the minute details of the nitty gritty of the segment. One of the important considerations for regulation in the nutraceutical segment involves getting the licence and developing country specific health and label claims.
In spite of the growth prospects of the segment there is ample confusion as far as the regulatory scenario is concerned. Discussing the present regulatory scenario, Kamal Anand, Senior General Manager - Consumer Products Division, Plethico Pharmaceuticals Ltd, says, “There is no clear cut definition or strict guidelines to define how a nutraceutical product in the market is created or sold. As a result, there are some grey areas. In some cases, a product is referred as a medicine and in some other instances it is referred as a food item. There is a lot of ambiguity that needs to be addressed.” Elaborating on this further Anand adds that people take advantage of this ambiguity. He highlights, “Since this segment does not have any definite guidelines laid down, it does not fall either into food or pharmaceutical sector. It completely depends on which way the end receiver considers it. Even with the introduction of a new law, situation has not improved much due to the hindrances caused by infrastructural problems and other issues.” Regulatory agencies in India do not encourage manufacturers to promote dietary supplements as natural products, but rather generally as drugs. Thus, it is difficult for manufacturers from the dietary supplement industry to compete with manufacturers within the (regulated) pharma market. Consequently, dietary supplement manufacturers must market their products within pharmaceutical
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Regulatory needs
In some cases, a product is referred as a medicine and in some other instances it is referred as a food item. There is a lot of ambiguity that needs to be addressed. Kamal Anand Senior General Manager - Consumer Products Division, Plethico Pharmaceuticals Ltd
industry regulations, under a drug or Ayurvedic manufacturing licence. The two Acts governing the Indian nutraceutical industry are classified under the following: Foods are covered under the Prevention of Food Adulteration Act (PFA) Drugs are covered under both the Drug and Cosmetic Act, 1940 and the Drugs and Magic Remedies Act, 1955 Classification of a product as either food or a drug is based on manufacturers’ marketing claims. When a product is marketed as a food, the advantage to the manufacturer is a less complicated process. However, some states still require product registration of these products as drugs. Under the PFA, functional foods are defined by Rule 32A as a ‘nutritional food,’ which is: “Food claimed to be enriched with nutrients such as minerals, proteins or vitamins.” To be compliant with the Act manufacturers, must include the quantities of such added nutrients on the label. If, on the other hand, a product is to be marketed as a drug, the drug category includes allopathic drugs, traditional medicines (eg, Ayurveda, Siddha, Unani-ASU and homeopathy), and can include vitamins, minerals and herbs. The advantage to a manufacturer under drug regulations is that if it is approved as a drug, appropriate disease claims are permitted. Like other drug/pharma regulations, pre-market approval is a definite requirement. It is also important to note that no fortified/functional foods are allowed under the drug regulations; these are covered under the Food Act.
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The Indian Food and Drug Administration/Food Safety and Standard Authority of India (FDA/ FSSAI) websites should be updated with more FAQs so as to render better precision to users. Mohit M Jain Executive Director & COO, Neiss Labs Ltd
Comparison note The Indian regulatory scenario is very different from that of the developed countries. Giving a comparative picture, Mohit M Jain, Executive Director & COO, Neiss Labs Ltd, avers, “Any user requires proper access to law and expect his/ her queries to be answered quickly and accurately. As compared to the US, the Indian regulatory system is very quick in responding to and resolving queries put forward by its users.” Elaborating on how India is different from the developed countries as far as the regulatory scenario is concerned, Anand avers, “In developed countries there is a clear cut demarcated way of functioning. For example, nutraceutical market in India is part of the Over-The-Counter (OTC) business. And I personally feel in India nothing is OTC and everything is OTC. But in developed countries the situation is different. There is a prominent line separating the prescribed and OTC products. In developed countries prescription products are never available without prescription and in case of OTC products though there is less medication, abundant information is available.” Talking about the difference, Jain adds, “The Indian Food and Drug Administration/ Food Safety and Standard Authority of India (FDA/FSSAI) websites should be updated with more FAQs so as to render better precision to users.”
Amendments required Based on the above discussion, it is apparent that few amendments are required in the Indian regulatory scenario.
Elaborating on the required changes, Anand says, “Even today there are too many unorganised players in the market. There are many nutraceutical products coming out of and inside the country. Everybody is competing on the delivering and pricing front. But in India, the end consumer is mostly not benefitted because there is no proper way to give information. These are the aspects that we need to look at. The end consumer must be informed about the positive and negative aspects.” He continues, “Strict guidelines are required that would determine which product will qualify as a nutraceutical product. Also, sometimes people take undue advantage in passing a product as a nutraceutical product. This further indicates that there is a tendency to entice the customer with false claims. And, the most unfortunate part of the whole thing is that they still get away with this.” Anand continues that nutraceutical segment is still at its nascent stage and is not very organised. Discussing on how the situation can be improved, he shares that there needs to be a record to show if a product is not pertaining to a certain level of conduct. There are several players in the market but not all of them are unorganised. Discussing the changes that are required, Jain remarks, “Amendments are required in terms of maintaining quality standards/protocols, maintaining claims on labels and enforcing & monitoring regulation. These changes shall bring the Indian regulatory system closer to the US operating standards.” (chandreyee.bhaumik@infomedia18.in)
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Special Focus: Pricing strategies of nutraceuticals
Aiming towards extended
affordability
Different cost of ingredients results in making the price of similar nutraceutical products varied. A sneak peek into the significant factors considered for the pricing of a nutraceutical product. Chandreyee Bhaumik
A
ccording to a recent report by Global Industry Analysts (GIA) the global nutraceutical market is projected to exceed $ 243 billion by 2015 due to the consumer desire for leading a healthy life and increasing scientific evidence supporting healthy foods. Further, rising healthcare costs, an ageing population and growing beauty affixation coupled with the introduction of supplements claiming to enhance beauty are expected to stimulate growth in the nutraceutical market. Elaborating in this regard, Hitesh Gajaria, Partner, KPMG India, avers, “While the US, Europe and Japan account for 85 per cent of the market share of the global nutraceutical market, India accounts for 1.5 per cent; thereby, indicating that the market is fairly underdeveloped in India.”
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Pricing strategy Fixing the price of a product is one of the vital decisions that is required to be made. Commenting in this regard, Gajaria points out, “To strategically price nutraceutical products it is important to consider the current need of the market, the products that are in maximum demand (depending on the awareness of health issues / disease profile / lifestyle in the region).” According to him it is imperative that manufacturers competitively price their products and advertise them using the right medium / channels in order to create the required impact within the target customer audience. He highlights, “There are numerous evolving trends that promote preventive medicine and self-treatment, which are likely to give an impetus to this segment.” The nutraceutical market has tremendous potential globally owing to the high-income levels of people in developed economies, greater awareness
of healthcare and widespread preferences for specialty nutritional products. Discussing other considerations for fixing the price of the nutraceutical product Gajaria continues, “In India it would be important to price the products keeping in mind the reluctance of the people to spend on health-related products apart from medicines or prescription drugs.”
Difference in prices Further, sometimes it is observed that a similar product is priced differently by different companies. It must be remembered that it is the quality of the ingredients used by different companies that marks the difference. Gajaria clarifies, “It is extremely essential that the higher prices of similar products need to be justified in terms of superior quality and better ingredients being used to manufacture it.” Talking about the pricing strategy, Bhavesh Shah, CEO and Managing
Modern Pharmaceuticals I May 2012
Pricing strategies of nutraceuticals
Availability of the ingredients is one of the important factors that need to be considered for fixing the price of a nutraceutical product.
To strategically price nutraceutical products it is important to consider the current need of the market, the products that are in maximum demand. Hitesh Gajaria Partner, KPMG India
Director, Euphoria Healthcare Pvt Ltd, explains, “Availability of the ingredients is one of the important factors that need to be considered for fixing the price of a nutraceutical product. Most of the time the ingredients required for producing the product is difficult to procure. Thus, the less availability of the nutraceutical ingredients along with a high level of consumption makes the nutraceutical product extremely expensive.” According to Shah, it is the demandconsumption pattern that determines the price of these nutraceutical products. He highlights, “Depending on the availability of the ingredients price of the nutraceutical products vary widely. It is only for a few products such as garlic capsules and some others that an optimum can be fixed.” Commenting on different prices of similar products, Dinesh Chauhan, Director, C & C Organics Pvt Ltd, says, “It is the cost of the ingredients along with the expense of the extraction process that make the nutraceutical products expensive. Therefore, products like lyco tine capsules, green tea extracts are expensive because of the high cost of the ingredients. The prices of the nutraceutical products fluctuate depending on the increase and decrease of the cost of the ingredients.” According to Gajaria following are the factors that need to be considered for fixing the price of a nutraceutical product: Evolving focus towards preventive therapies The increase in disposable income Increasing bend towards the concept of self-medication
May 2012 I Modern Pharmaceuticals
Bhavesh Shah CEO and Managing Director, Euphoria Healthcare Pvt Ltd
The increase in number of wellness and pharmacy-related retail chains Favourable and appropriate pricing environment The ever-changing demographics The growth in healthcare spending The increasing focus on beauty and the positive endorsement of supplements that claim to enhance it Gajaria says, “These factors will create opportunity for non-core pharma companies and also provide a widening of offerings for pharma companies. For example, the nutraceutical segment gaining traction would reflect upon the general public’s awareness towards healthcare. It endorses the idea of better lifestyle and health and the supplements are aimed to provide nutrients that are missing or are not consumed in sufficient quantity in a person’s diet.”
Difficulties faced Determining the price of a product is not an easy affair. Elaborating on this Shah says, “The biggest challenge that is faced is explaining the price to the consumers. Extraction is an extremely expensive process and it is very difficult to explain this to the end consumers. In majority of the situations it is the psychological barrier that prevents the end consumers from accepting the high price of the products.” Shah explains that it is almost a challenge to explain the nutritional and health benefits of the nutraceutical products to the consumers. He reiterates, “Various products such as pomegranate capsules for slimming, garlic capsules for cardiac, etc are expensive because of the high cost of the ingredients. The entire
process of extracting the ingredients to converting them into formulations is expensive. And it becomes very challenging to explain this to the consumers.” Talking about the challenges, Gajaria opines that the challenges faced by the nutraceutical market are lack of standardisation perception of high prices, lack of awareness about nutraceutical products in the market coupled with marketing and distribution challenges. He remarks, “The nutraceutical market is highly competitive and driven by several factors such as safety, price, efficacy, brand loyalty and packaging. However, the major issue faced currently is maintaining consumer brand loyalty due to the growing similarity among products and formulations available in the market.” An effective way to overcome these challenges would be by endorsing the products available in the market via the right advertising channels. Gajaria says, “Proper awareness is a prerequisite to increasing acceptability. The key players should ideally employ the various available mediums to advertise their products and also highlight the specialty of their product in comparison to competitor products. It would also be useful if a renowned dietician/nutritionist endorsed a particular company’s product as it would considerably improve brand recognition and increase product credibility.” Thus, the pricing of a nutraceutical product is not a complex process but involves a great deal of thinking and planning as satisfying the end consumer is the prime target. (chandreyee.bhaumik@infomedia18.in)
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Special Focus: Interface - V Bhasker Rao
“The key challenge of this segment is maintaining the quality material as feed stock” …says V Bhasker Rao, MD, Nandan Biomatrix Ltd, who has brought in scientific and systematic approach for the natural products industry in India. Here, he talks about the growth of the segment. Titash Roy Choudhury
What fuels the growth for Nandan Biomatrix? India has a rich traditional heritage in the field of Indian system of medicine, and ayurveda being one of the most traditional Indian medicine systems addresses individuals with its understanding about the holistic aspect of human beings functioning as a whole - this was the basic platform for Nandan. We have looked into the requirements of natural products industry connected to quality, quantity and consistency of products for India and abroad based on which we have created a roadmap for medicinal plants producing improved therapeutic content in cultivation, processing and extraction and its effective packaging resulting in state-ofthe-art products in the global markets. Has nutraceuticals developed as a defined market segment in India and how has Nandan Biomatrix worked towards achieving the same? The Indian nutra market is coming up with increasing emphasis on fortified benefits as well as lifestyle product range concentrating on health and well being. It is a fast growing segment providing the greatest opportunity and Nandan has put in efforts to achieve its market share in this segment. Our nutraceutical business has three segments: formulations, standardised herbal extracts and export.
How crucial is R&D for the development of nutraceuticals and does Nandan Biomatrix invest significantly? R&D is the key component for progress of any industry and is more relevant for nutra segment throughout the entire process of farming to product manufacturing. Proper R&D results in improved varieties of herbs and medicinal plants producing a higher therapeutic content, improving method of cultivation and effective processing methodologies resulting in world class products. We have focussed on R&D in all the segments and hence we are confident of our market share in this segment. What challenges are faced by this market in a country like India and are Indian pharma companies willing to enter this segment? The key challenges of this segment are maintaining the quality material as the feed stock, developing the products suitable for various applications, and of course, marketing of the products for profitability. We have realised that to address these key challenges of maintaining the quality, quantity and consistency we need to develop a scientific and systematic approach for the segment. With growing popularity of this market segment we have seen several Indian pharma companies entering the same.
What has been the growth strategy of your company for the last five years and how are you gearing up for the coming years? Growth strategy for the company has been mostly in developing scientifically validated innovative products targeting lifestyle disorders in healthcare and well being segment. We have developed highly efficient aphrodisiacs products for men and women and value-added aloe vera products for general health. We at Nandan follow unique product development process, which set forth from scrutinising traditional leads till marketability. Our standardised extracts supplies are accompanied by analysis reports of microbial, heavy metal and pesticide residues. We carry out chemicalfree processing at low temperatures to retain its purest form without altering the active ingredients nutritional and functional properties and its inherent therapeutic principles. What are your plans with regard to expansion/product launches? In this era of greater awareness of health and preventive medication, grasping the eminence of nutraceuticals across the disease segments is essential and so we are expanding our phase 2 facility with high technology functional food processing unit. (titash.choudhury@infomedia18.in)
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Special Focus: Roundtable
Will an Act like the Drugs Prices Control Order (DPCO) help? There are frequent claims that nutraceutical products are extremely high priced and varied. In this scenario, will an Act like DPCO help to better the situation? Chandreyee Bhaumik
Dhiren P Dalal Director, Herbal Hills Nutraceuticals are made out of natural ingredients and therefore the cost of these products is based on the price of raw materials. On the other hand, in case of generic drugs, the cost is based on chemical formulae. And thus naturally, the pricing strategies of these two segments of the products are completely different. In this scenario, I feel that Acts like DPCO will not be of much help. Additionally, depending on the quality of the raw materials (natural ingredient) the price of the same nutraceutical product may vary from company to company. A perfect example in this situation is Chyawanprash. The price of the product is different for different companies. But in the case of allopathic medicines the cost of the product is the price of formulae. Thus, while for generic drugs DPCO can be implied I am unsure about the implication of DPCO for nutraceuticals.
Dr H G Koshia Commissioner, Food & Drugs Control Administration, Government of Gujarat It is important to note that nutraceuticals are not considered to be essential drugs. It still falls under the category of food supplements. Further, nutraceuticals do not have much of curative value as it is more of a special type of food supplement. In this regard, it can be said that DPCO primarily applies to medicines, in particular, essential and licensing medicines. Therefore, I do not feel that DPCO would be of much use as far as the pricing of the nutraceuticals is concerned. However, I agree that the high price of the nutraceutical products is a matter of concern. Thus, manufacturers should try to have a price control check on their own and regulate the price of these products. On the other hand, it is sometimes observed that the prices of the same nutraceutical product vary from one company to the other. This is primarily because of the different quality of ingredients used in the same product by different companies.
Vikram Gupta Founder & Managing Partner, IvyCap Ventures Advisors Pvt Ltd It is not easy to implement DPCO in the nutraceutical market right now. Though the market size is quite substantial the Indian nutraceutical market is still coming up. However, the main issue is that the majority of the market is still treated as the Over-The-Counter (OTC) market and not the prescription market. Hence, most of the players are Fast Moving Consumer Goods (FMCG) kind of players, who operate on the typical FMCG margins. Further, most of the nutraceutical products are not treated as life-saving drugs or products. They are mostly the preventive kind of products. I feel this is the basic issue. It is not going to be easy to bring the nutraceuticals under DPCO though it might be a good approach for some of the products under that category. If the nutraceuticals come under DPCO it will be of help to the end consumers as the prices of the high priced nutraceuticals will come down.
Editorial take
Nutraceuticals do not come under the purview of essential drugs as they are mostly concerned with wellness. In this scenario, there is an urgent need to look beyond Acts such as DPCO that deal with pricing of essential drugs.
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Modern Pharmaceuticals I May 2012
Roundtable
Are Indian pharma companies investing enough in nutraceuticals? Indian lifestyle has undergone a massive makeover. The demand for nutraceutical drugs such as multi-vitamins and protein supplements are increasing but are pharma companies investing enough in the segment? Titash Roy Choudhury
Abhijit Bhattacharya Chief Operating Officer, Omni Active Health Technologies
S V Veerramani Managing Director, Fourrts (India) Laboratories Pvt Ltd
Sanjay Dhir CEO & MD, Zen Labs India
The nutraceuticals segment has seen a steady growth since 15 years all over the world and has finally gained some foot in the Indian market. Not only pharma and food companies are eyeing this segment, exclusive nutraceuticals companies are emerging to particularly cater to this segment. A whole range of products in protein supplement, energy supplement is emerging along with variety of dietary supplements such as multi-vitamins or OTC products. Then, there are also multivitamins that are targetted separately for men and women. There are many pharma companies investing in this segment to come up with their own dietary supplements and multivitamin tablets to meet the growing demands. Considering as an emerging segment, nutraceuticals has huge scope of expansion and growth for pharma and food companies. Pharma companies are willing to enter this segment to expand their product portfolio. But they are new to this and more awareness is required for creating better opportunities.
The nutraceuticals market is encountering a booming growth worldwide and India is not lagging behind in this trend. Today, awareness regarding this segment has also increased considerably in India and among Indian companies. But one aspect that is still holding back the involvement of pharmaceutical companies in this segment is the lack of clarity with respect to nutraceuticals in India. When it comes to the regulatory status, it is not well defined in this country. Though nutraceuticals have been classified into food and drugs separately there are some that are neither classified as drugs or food. Although there has been some move earlier to create a separate group for nutraceuticals with proper regulatory status, it has not taken off so far. Under this unclear situation, Indian pharma companies are not able to invest enough in nutraceuticals. If the government provides a proper regulatory status to nutraceuticals, the companies will be able to invest with confidence.
Nutraceuticals form a crucial part of the day-to-day life of any person considering the basic element of any nutraceutical is anti-oxidant that fights with the free radicals being developed by the human body, which can cause harmful diseases including cancer. Nutraceuticals help in keeping the body active and considering the hectic lifestyle being led by Indians this segment is of immense importance. Although there is a huge demand for the same and there is an increasing population of India, pharma companies are not investing enough in this segment. And one of the main reasons demotivating them is the intervention of Drug Price Control Order (DPCO). The basic component of any nutraceutical is vitamin and the price of most of these vitamins is controlled by DPCO. And looking at the price of the raw materials and cost of production vis-Ă -vis the retail price fixed for most of these vitamins, the pharma companies do not see it as a viable opportunity since there are hardly any profits.
Editorial take
The nutraceuticals segment is attracting many players from the pharma market. In India, there are still a few constraints that needs to be cleared before companies can look at this segment as a good investment destination.
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Facility Visit: Jubilant Life Sciences Ltd
Banking on integration In 2007, the ‘Vibrant Gujarat’ conference witnessed the signing of a Memorandum of Understanding (MoU) between Jubilant Life Sciences Ltd and the Government of Gujarat for the establishment of a sectorspecific Special Economic Zone (SEZ). Inaugurated in April 2012, this SEZ is spread over 300 acre of the Vilayat Industrial Estate of Bharuch district, Gujarat. Parita Dholakia
J
ubilant Life Sciences Ltd is an innovation-driven pharmaceutical player catering to the demands of the global life sciences industry. Established as a strong and leading Custom Research and Manufacturing Services (CRAMS) player and Drug Discovery and Development Solutions
Manufacturing plant for 3-cyanopyridine
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(DDDS) provider outside India, the company is constantly endeavouring to move up the value chain. Jubilant Life Sciences leverages its focus on innovation and customer satisfaction and serves 150 customers from over 50 countries. It widely divides into two business segments: life sciences products and life sciences services. On April 13, 2012, a sector-specific SEZ for
chemicals was formally inaugurated by Narendra Modi, Chief Minister, Gujarat. This SEZ is spread over 300 acres at the Bharuch district in Gujarat, and is built with an investment of over ` 500 crore. With this SEZ, the company started the commercial production for niacinamide, which has a capacity of 10,000 Million Tonnes Per Annum (MTPA) niacinamide and 3-cyanopyridine.
Jubilant SEZ We visited the manufacturing facility for these nutritional ingredients and Proprietary Product & Exclusive Synthesis (PPES). Spread over 300 acre of land developed at the Vilayat Industrial Estate, it houses world scale plants for Vitamin B3 (niacinamide), 3-cyanopyridine, and fine chemicals like 2,3,5-collidine, 2,3-lutidine& 3-amino methyl pyridine. These global scale plants of Vitamin B3 and 3-cyanopyridine at SEZ make Jubilant the largest producer of Vitamin B3 in India and second largest globally. The SEZ also has a manufacturing plant for Symtet, a crop science ingredient for one of the world’s largest and safest low cost insecticide through an environment friendly process. This will make Jubilant the world’s largest producer of the crop science ingredient for the insecticide through green route. Jubilant SEZ houses state-of-theart & world class general, specialised & specific industrial infrastructure facilities, appropriate & adequate social infrastructure facilities and the right atmosphere & environment for achieving new horizons for the Jubilant Bhartia Group. The group is hopeful of generating over ` 1000 crore revenue as and when the SEZ becomes completely operational. This SEZ currently provides direct and indirect employment to over 600 persons. It is well connected to road network through developed roads and national highway, to railway network through western railway line and waterways due to its proximity to Dahej Port. The facility has a constant supply of water and power and ample effluent drainage facilities provided by state government. “Jubilant SEZ is first of its kind in India - largest capacity, fully
Modern Pharmaceuticals I May 2012
Jubilant Life Sciences Ltd
All other plants throughout the world produce the raw material through petrochemical route and hence have a much higher carbon foot print in comparison to our green process.
Jubilant SEZ is first of its kind in India - largest capacity, fully backward integrated, in-house developed innovative technologies and world class quality products. Hari S Bhartia Co-Chairman & Managing Director backward integrated, in-house developed innovative technologies and world class quality products,” beams Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Ltd. PPES accounts for more than 27 per cent of overall sales of Jubilant Life Sciences. Proprietary Products (PP) and Exclusive Synthesis (ES), helps the company to monetise its expertise in pyridine chemistry. This new manufacturing facility is expected to further boost sales from the PP segment. Speaking about the USP of the SEZ, Shyam S Bhartia, Chairman & Managing Director, Jubilant Life Sciences, avers, “The starting raw material for the agrochemical & the nutrition product facilities are pyridine and beta picoline, respectively, which the Company produces in Gajraula, UP, using renewable resource such as alcohol produced from sugarcane molasses. All other plants throughout the world produce it through petrochemical route and hence have a much higher carbon foot print in comparison to our green process.” Revenue generation from nutritional products has remain stagnant, but the management is hopeful for better traction, going ahead, with new launches via new capacity and newly derived applications in cholesterol lowering market for Vitamin B3.
‘Partner of choice’ Jubilant Life Sciences is the flagship company of Jubilant Group (13,000+ employees), having business interest in pharma life sciences & specialty chemicals, oil & gas (exploration & production), food & retail and consulting services in aerospace and oilfield services. Incorporated in 1978 as a mid-sized chemical player, it has gradually shifted
May 2012 I Modern Pharmaceuticals
Shyam S Bhartia Chairman & Managing Director into pharmaceuticals. The group caters across the entire pharma value chain: drug discovery, R&D services and commercial manufacturing of Advance Intermediates (AIs), Active Pharmaceutical Ingredients (APIs) and other generic drugs. It has manufacturing facilities in India in UP, Maharashtra, Karnataka, Gujarat, and also in USA and Canada. It serves its customers across the globe and it is well recognised as the largest CRAMS
With the USP of being vertically integrated, it is well placed to maintain margins and profitability despite volatility in pricing.
company out of India. Over the years, it has extended its footprint beyond India in the USA, Canada, Europe, and other countries across the globe. It expanded its business by building capabilities internally, through strategic build outs and acquisitions, resulting in a network of 7 world-class manufacturing facilities in India and 3 in North America and a team of around 6300 people across the globe with around 1500 in North America. Recently, it has been ranked number 6 amongst the Top 10 global contract manufacturing & services outsourcing players of the pharmaceutical industry. With the USP of
being vertically integrated, it is well placed to maintain margins and profitability despite volatility in pricing. Corporate Social Responsibility (CSR) is an integral part of how it conducts its business and all their efforts are directed towards community development through focus on primary education, basic healthcare service, and livelihood generation programmes focussed on improving the employability of women and local youth. The company and its managing directors have been recongnised with several awards, which bear testimony to its commitment towards operational excellence, innovation, corporate governance and social responsibility.
Prospective growth The company expects margin expansion in CMO and DDDS on account of a full year’s impact from signed contracts, traction in clinical trials and boarding of integrated programmes from key customers. Capacity expansion in proprietary products & exclusive synthesis, nutrition ingredients and APIs are also expected to boost revenues going forward. The launch of new products is expected to further strengthen Jubilant Life Sciences’ performance. With an aim to leverage innovation and scale of operations at every step of the pharma value chain to deliver value to stakeholders, the company has set its sight on the right track. Standing amid the vast acres of land, and seeing the production operation in full swing leaves one no doubt that the SEZ will achieve its set target sooner than later.It may be a new child to Jubilant Life Sciences, but in the near future it is accomplished to take some huge strides. (parita.dholakia@infomedia18.in)
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Insight & Outlook
Active Pharmaceutical Ingredients (APIs) Contract manufacturing API market Focus on emerging regions ................................................. 40 HP APIs for biogenerics Potential unexplored .......................................................... 42 Interface Amitabha Gangopadhyay Senior Director – Business Excellence and Strategy, Sanofi India ............................................................................44 Roundtable Is China a threat to India for APIs? ..................................... 46 Clinical research industry Why cynical about clinical? ................................................ 48 Influenza vaccines market Significant unmet needs ..................................................... 50 Access to healthcare Need to focus on infrastructure and healthcare delivery ............................................................. 52 Peristaltic pumps Moving beyond the labs ...................................................... 54 Case Study - In-sight vision systems High-speed pharmaceutical glass vial inspection ................. 56
May 2012 I Modern Pharmaceuticals
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Insight & Outlook: Contract manufacturing API market
Focu
on
emerg ng regions The global API market has encountered significant growth over the years. It is predicted to double in size in by 2021. With such prospects, emerging markets like India and China are becoming promising destinations for contract manufacturing of APIs.
by India and Italy, US is the largest consumer followed by Europe,” informs Dr Shrikant D Sawant, Director, Centaur Pharmaceuticals. He further adds, “API market is being fuelled by generic players as the demand for generics is growing at more than double that of prescription drugs due to the growing acceptance of generics by all stakeholders.” India is a key API player offering good quality at reasonable price. The Indian API market was $ 12 billion in 2010 and has grwon over 9 per cent with 60 per cent exports.
Growth drivers
Titash Roy Choudhury
G
lobally the Indian pharmaceutical market holds third position in terms of volume while for value it occupies the 14th place. Over the last decade we have seen a manifold increase in the potential of Indian pharma market especially in manufacturing where India has created its own niche. With high quality standards and compliance to regulatory standards, today India has more number of US FDAapproved manufacturing units
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than its competitor market China. Gradually, India is becoming a hub of manufacturing and also attracting MNCs for outsourcing of manufacturing. The Indian contract manufacturing market for formulations is around $ 3 billion growing at over 40 per cent driven by high quality - low cost production models and manufacturing proficiencies. In the recent years we have seen growth of Active Pharmaceutical Ingredient (API) market worldwide. “Global API market is $ 100 billion and growing at 8 per cent. While China is the world’s leading manufacturer by volume followed
A report by Companies and Markets has shown how drug makers from developed countries like the US will be looking towards API makers like India and China. At present, US is currently the biggest market for APIs, but Asia and the Pacific region are forecast to grow 9.6 per cent annually over the next five years, highlights the report. The trend indicates that gradually manufacturing of APIs will be shifting to emerging economies such as India and China. Contract manufacturing has been a strong segment for Indian markets as there are various factors propelling the growth in India over its western rivals. Costs are very competitive in India. The cost involved in setting up and running a new manufacturing facility in India is only two-fifth of that in West. Given the low development and labour cost the units can operate on lower margins. The expertise gained in manufacturing generics through reverse engineering has also helped in the process. “The demand for API will always be there as long as there is demand for formulations. Contract manufacturing for APIs will increase in the coming years, given the fact that MNCs will increasingly outsource the production process to India,” says Susheel Koul, Director, Enaltec Labs. But encompassing contract manufacturing
Modern Pharmaceuticals I May 2012
Contract manufacturing API market
Contract manufacturing for APIs will increase in the coming years, given the fact that MNCs will increasingly outsource the production process to India.
While China is the world’s leading manufacturer by volume followed by India and Italy, US is the largest consumer followed by Europe. Dr Shrikant D Sawant Director, Centaur Pharmaceuticals
market for API is difficult since it is highly fragmented with many small players operating with different models. “Some API manufacturers have capabilities to synthesise API from conceptualisation to commercialisation like Centaur Pharmaceuticals in psychotropic API. Other manufacturers specialise from N-1, N-2 stage to the actual API. Many generic players prefer to get the different stages of manufacturing done from different players to maintain confidentiality,” says Dr Sawant. But strong chemistry skills, developed API synthesis and manufacturing capabilities, adaptability and high quality at lower prices are the key drivers for API manufacturing in India. These factors are attracting more and more companies from developed economies to outsource manufacturing to emerging markets like India. According to a report by Visiongain, the revenues from global contract manufacturing market are expected to hit $ 64 billlion by 2016, and more than double between now and 2021. India needs to gear up for this predicted rise in the contract manufacturing market worldwide and prepare itself aggressively to take advantage of the drugs that willbe are going off-patent in the coming years. Some Indian manufacturers are also now incorporating Lean Manufacturing and Six Sigma principles to help boost operational efficiency and further improve quality, while facilitating compliance. There is major
May 2012 I Modern Pharmaceuticals
Susheel Koul Director, Enaltec Labs
development taking place in the contract manufacturing of patented APIs in Indian market and India has the potential to become the global API hub in the coming years.
Future scope of this segment There is no defined contract manufacturing market for APIs in India currently but looking at the growth of the global market the future; the same is profitable and worth investing. “As
According to Visiongain, API manufacturers in both India and China will achieve increasing demand for their services and demand for generic and HP APIs will drive the growth of this market from 2011 to 2021.
India manufactures all APIs, the generic players purchase directly from the API manufacturers; almost no contract manufacturing involved. The latest technology and processes are available in India at lower costs hence even innovators purchase directly from the API manufacturers. However, technology
for biotech API or monoclonal antibodies and biologicals are not yet well developed in India, which may lead to API contract manufacturing in the future,” says Dr Sawant. One of the challenges that may hinder the growth will be tough competition from China. According to Visiongain, API manufacturers in both India and China will achieve increasing demand for their services and demand for generic and HP APIs will drive the growth of this market from 2011 to 2021. “Although India is self sufficient in APIs we still purchase 50 per cent of APIs from China due to price economies. However, India is adept at manufacturing high-end API whereas China is fast catching up,” informs Dr Sawant. Fluctuating prices of raw materials may become a hindrance to the growth of the market for India. Koul points out, “There is going to be a slow shift from contract manufacturing to contract research where the company will be asked to do some research on the product and then manufacture it too.” Some Indian pharma companies could probably benefit significantly by moving towards specialty APIs in the future. With an unregulated market, contract manufacturing for API has not been tapped fully in India. With skilled labour, technical expertise and manufacturing units complying with regulatory standards, India can become one of the preferred market for contract manufacturing of APIs. (titash.choudhury@infomedia18.in)
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Insight & Outlook: HP APIs for biogenerics
Potential unexplored Worldwide, the biogenerics market is growing exponentially and emerging markets such as India and China are leading the way. With APIs contributing highly to the development of any formulated end product, will High Potency APIs (HP APIs) find a role to play for biogeneric drugs?
several companies launching new products and biosimilars in oncology, hormone and steroids segments. The growth is primarily driven by generic products in emerging markets.” Among factors that are driving growth of HP API, it will be augmented by the oncology segment as they are predominantly used for the manufacture of cancer drugs. Considered especially effective for targeted therapy areas, HPAPIs are largely deployed for the manufacturing of drugs in niche therapy segments. “Moreover, HPAPIs are frequently being used on account of their effectiveness in relatively smaller dosages as compared to other APIs, which require higher volumes,” informs Dr Karkaria. Considering the effectiveness of HP APIs and the evolvement of biogenerics market worldwide, HP APIs will have a bigger role to play in this segment.
Biogenerics: Potential growth in India
Titash Roy Choudhury
B
iogeneric is gaining prominence with time and for generic manufacturing market such as India it holds more possibilities. The generic version of biopharmaceutical is usually known as a biogeneric drug, different from a biotech drug. When pharmaceutical products contain active ingredients that are biological in nature and are manufactured using live organisms then it is known as a biopharmaceutical. And the generic version of a biopharmaceutical can be termed as a biogeneric drug. These drugs, which are usually the generic version of biotech drugs, hold huge potential for a generic pharmaceutical market like India. With expertise in generic manufacturing of several years along with high number of approved manufacturing units, India
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is going to hold the helm of biogenerics in the coming years. For any formulation, Active Pharmaceutical Ingredient (API) forms the basic component of any formulated end product, ie is the drug and in this case the biogeneric drug and when we talk about High Potency APIs (HP API) we refer to small molecules, having greater potency and are able to target and eliminate specific maladies, often taking patient-specific genetic information into account. “The expectation is that the share of HP APIs in the overall API market will continue to see increased growth with a Compounded Annual Growth Rate (CAGR) of 8.3 per cent from 2011 to 2016,” informs Dr Cyrus Karkaria, PresidentBiotechnology, Lupin Ltd. While KV Subramaniam, President and CEO, Reliance Life Sciences, says, “The HP API market is growing at a healthy rate with
The biogenerics market in India is about ` 1,300 crore including recombinant proteins and monoclonal antibodies. The biosimilar market is growing at a fast pace in India too catching up with other growing segments. However, for being a truly global leader in this space, India would have to focus on the following aspects of addressing a deficiency in the regulatory approval process, emphasising highest standards of quality of biosimilars, developing human competencies and accessing regulated markets. “The biogenerics segment can also offer significant opportunity to Indian players, given the advantage that India has in its rich talent pool, technical expertise and comparatively low operational costs,” says Subramaniam. With the impending patent cliff, in 2016-17, drug companies, across the world are focussing on niche therapy areas where investments are high but margins are quite rewarding. “Biogenerics, in India, has tremendous growth potential and most leading Indian pharma companies are working towards tapping that potential. According to statistics from Datamonitor, the Indian biosimilars market is expected to grow to $ 580 million (` 2,580 crore) in 2012,” says Dr Karkaria.
Modern Pharmaceuticals I May 2012
HP APIs for biogenerics
The HP API market is growing at a healthy rate with several companies launching new products and biosimilars in oncology, hormone and steroids segments.
Biogenerics, in India, has tremendous growth potential and most leading Indian pharma companies are working towards tapping that potential. Dr Cyrus Karkaria President- Biotechnology, Lupin Ltd
Offereing hopeful solutions The advent of biopharmaceutical drugs has helped address unmet medical needs. However, only a fraction of the patient population has been able to afford these drugs due to the steep prices they command. The entry of biogenerics will pave the way for affordable therapy, consequently benefiting a larger patient population. “The biopharmaceutical industry is expected to see strong growth in the coming years, driven by growing markets, several new biosimilar product launches in India, exports of biosimilars and product-based partnerships. This
May 2012 I Modern Pharmaceuticals
K V Subramaniam President and CEO, Reliance Life Sciences may lead to an increased demand of HP APIs in the domestic market,” says Subramaniam. Biosimilar market is growing at a faster pace in India and a similar trend is seen in emerging markets. However, their growth in developed markets (especially EU) has not met the expectations of pharmaceutical companies. This is primarily due to the fact that these products are marketed as ‘branded generics’ and are not ‘interchangeable’. Further, there is still no clarity on the regulatory approval pathway in the US for development of biogenerics. So clarity in the regulatory front is something that is required. All the
biotech companies in India are gearing up for the removal of patent cliff from biotech drugs so that they can venture into generic versions of these biopharmaceuticals. With such a favourable condition the demand for not only APIs but also HPAPI will rise for manufacturing biogeneric drugs. The efficacy and performance of HP APIs is undoubtedly superior to APIs and they are required in small volumes considered to APIs. Thus, with the increase in production of biogenerics in the coming years we will also see an increase in the demand for HP APIs. (titash.choudhury@infomedia18.in)
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Insight & Outlook: Interface - Amitabha Gangopadhyay
“Diagnosis, doctors and drugs are three critical elements driving the growth of the pharma industry” …believes Amitabha Gangopadhyay, Senior Director – Business Excellence and Strategy, Sanofi India. He has been a part of some mega M&As in the industry. Here he talks about the mega transformation of the industry. Titash Roy Choudhury
What motivated you to be part of this industry? My ambition was to become a doctor but somehow it did not happen and rather I studied Human Physiology, which is the basic of medical science. After doing Masters in Physiology from Presidency College, Kolkata, I was inspired by some of my relatives in this industry who with their touching anecdotes made me see this profession in a light where one could significantly contribute to the health of people. Moreover, the profession dealt deeply with my subject, which further motivated me. I thus began my career as a Medical Representative with GlaxoSmithkline. How has the Indian pharma industry evolved over the last two decades? The fundamentals of health-related industries have undergone a sea change, having not only impacted pharma but the overall healthcare industry. These changes can be explained in various ways, such as increase in the overall ‘health awareness’ of Indians though still at a nascent stage (in comparison to the developed world). We need to realise a very simple fact of life that our body while through its wear and tear, is at risk. This must be recognised and dealt with (put to practice) proactively with a positive attitude. Having dealt with ‘awareness’ and the issue of ‘realisation’, comes the question of affordability.
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Affordability does not only mean having more money (disposable income); rather, its adequate knowledge and education coupled with disposable income. Quite a part of the societal segment is becoming truly ‘affordable’, though the number is relatively small in comparison to the overall population. There has been a great deal of changes in the disease pattern resulting in tremendous changes in therapeutic development. Earlier, communicable diseases used to be more than 60 per cent, which today is only 30 to 35 per cent. This shift is a major one. Today, the acute therapies are better understood and the awareness of chronic disease is increasing. A great deal of transition in the infrastructural design is seen throughout the country. The practice of empirical medicine is gradually shifting towards evidence-based medicine. All the above mentioned facts are driven by a quantitative and qualitative change in the medical fraternity resulting in the overall growth of the pharmaceutical industry in India. Some time back, 80 per cent of the market used to be dominated by MNCs. Due to the spurt of growth by the Indian players, we today see a reversal of the picture - 80 per cent of the current market is now dominated by Indian companies, and some of which have gone global. The awareness at the physician as well as the patient level has played a
pivotal role in the growth of the pharma market than the number of medicines being made available at an affordable price. Hence, emphasis on education and awareness is more critical than an introduction of a low-priced medicine. Therapeutic segments and areas have gained prominence over the years in India. In the earlier days, the industry used to be absolutely ruled by acute therapies. Today, we observe substantial growth of chronic therapies. However, this compositional shift is slower than the occurrence of disease. This is simply due to the fact that 60-70 per cent of the population has poor access to infrastructure/medicine in the semiurban/rural India, which is still ruled by acute therapies. Among the chronic therapy areas, we see a great spurt in cardio and diabetes. There are other emerging therapies such as central nervous system (for example, epilepsy etc) and oncology, which are gaining prominence. Factors that are parallel to growth As has been mentioned by many experts, the future growth can be explained through three different scenarios based on the overall economy, government policies and of course the progress of health awareness and attitude. Scenario 1: At the current pace of economy growth, governmental pricing policy and the attitude to
Modern Pharmaceuticals I May 2012
Amitabha Gangopadhyay health, the pharma market will see a decent double digit growth Scenario 2: An optimistic scenario whereby the government policies considerably boost the health economies, substantial investment pours in from various private/ public quarters to build up the basic infrastructure required for diagnostics and other health care amenities. In such a scenario, the industry will see superlative growth. Scenario 3: A conservative scenario where all the factors mentioned above do not support the infrastructure and other health amenities. In such a case, the industry will slow down to a large extent. However, at this juncture this is quite an unlikely scenario. What role has the government played in this growth? We have to look at the growth from an overall perspective. Pharma industry is not a stand-alone entity. As the overall healthcare scenario progresses, pharma
industry gets an impetus. Government policies are more directed towards the correction of the fundamentals of healthcare. That is how the overall improvement in economy is supported by some of the policies, which drive infrastructural growth and the reach of medical facilities to remote areas. The government has worked across segments and is now coming up with partnership models that can further boost the reach of medical science. What trends do you foresee in the Indian pharma market? Today, it is estimated that 25 per cent of the overall healthcare industry in India is pharma. This is likely to grow because of the rise in chronic therapies. More awareness, education and diagnostic facilities will pull in patients at a very early stage who will have better prognostic evaluation, insurance coverage etc. thus will remain in-therapy for an adequate period of time and maintain better health status.
On the other hand, the progress of medical science, medi-devices, specialised hospitals will bring in various procedural facilities which will be availed by Indian patients as well as patients of our neighboring countries and far off (medical tourism). Within the pharma space, therapeutic segments like cardiovascular and diabetes will see a major spurt along with more life style oriented therapy areas, viz, dermatology, respiratory, CNS & gynaecology. The incidences of cancer being on the rise and simultaneous discoveries in this field will definitely provide better opportunities for treatment. Another growth area is vaccines which will be augmented by research along with many more incoming advanced therapeutic solutions through biotechnology. All this will change the pharma world substantially in its composition and quantum. (titash.choudhury@infomedia18.in)
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 1,500 words, while that of a product write-up should not exceed 100 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 be sent a complimentary copy of that particular edition. Published by Infomedia 18 Ltd, ‘Modern Pharmaceuticals’ is one of the leading monthly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertiserss are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,
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T +91 22 3024 5000 D +91 22 3003 4669 F +91 22 3003 4499 E manas@infomedia18.in W www.infomedia18.in
May 2012 I Modern Pharmaceuticals
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Insight & Outlook: Roundtable
Is China a threat to India for APIs? The tussle between two of the growing economies in the world is growing stronger day-by-day. Today, the Active Pharmaceutical Ingredient (API) market is encountering significant growth and both India and China are trying to capture the global API demand. Titash Roy Choudhury
Ravi R Sobti Independent Pharmaceutical Consultant
Vinod Kalani Chairman, MSME, Sub-Committee, IDMA
Rahul Kirkinde AGM- Marketing & Technical, Ideal Cures Pvt Ltd
There are certain processes in APIs where China has an edge over India. Like China can be called a threat for India when it involves fermentation processes. China today has advanced technologies when it comes to fermentation and all the processes involving fermentation. So when it comes to production of penicillin or steroids China stands ahead of India. India is currently importing steroid intermediates, steroid hormones to meet the country’s demand. But when it comes to processes based on synthetic chemistry India is way ahead of China. On regulatory compliance too, India’s track record is better than China; there are significantly higher numbers of USFDAapproved API production houses in India than in China. Whereas in few areas China has an upperhand there are certain aspects for API production where India is leading, so we can say that instead of being a threat to one another they are tough competitors when it comes to APIs.
When it comes to manufacturing facilities for API, China is ahead of India since the manufacturers receive aid and facilities from the government. Chinese companies receive support from the government for getting loans, clearances are made faster that gives Chinese manufacturers an edge over India when it comes to intermediates for APIs as well as APIs. India exports intermediates for APIs from China. Earlier many Indian manufacturers were entering the API and new molecules market, but with the price control brought in action many units were closed down. So the momentum slowly diminished for the Indian API companies. The government should develop policies that are clear and consistent so that new players enter the market. Looking at the present scenario I consider China as a threat to India and Indian government should work towards providing a more level playing field.
When it comes to API market India has an edge over the Chinese APIs. API forms a very important part of the formulations and when it comes to getting an API for the formulations developed markets like Europe will always prefer an Indian API over a Chinese API. But when it comes to the formulators of the domestic market and rest of the world such as the African countries or Middle-eastern countries would opt for a Chinese API. Chinese API gained prominence in the 90s but in the recent past there have been several cases where the quality of the Chinese API has come under the scanner. The problem is quality. The API may pass through primary tests but gets a red light for advanced stages such as impurities test or deviation tests. And due to these quality issues Chinese API has degraded in its value. Thus, at least China cannot be termed as a threat to the Indian API market.
Editorial take
While for certain processes China is taking the lead in API but when it comes to quality, Chinese API is still facing a tough time. India is slowly catching up and Indian API is preferred all over the world, which shows the continuing progress of Indian products.
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Modern Pharmaceuticals I May 2012
Insight & Outlook: Clinical research industry
Why cynical about clinical?
S
ome years ago, Indians encountered a particularly motivational slogan: ‘India Shining’. Although the slogan had a political genesis, it contained the right cues that imbued common persons with positive energy. ‘India Shining’ definitely sounded realistic, making every Indian proud. It enabled many players to place India on the global map in the areas of innovation,
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development and healthcare sector.
quality
in
the
Why the myth? Over the past few months, however, the CR industry has been besieged by media reports and statements from various government quarters reflecting abject ignorance about the CR industry, inaccurate reporting as well as political twists and turns. All of this has created
Inaccurate reports have tarnished the Clinical Research (CR) industry’s once-glorious image, disregarding the fact that worldwide no drugs can be launched without human trials. an extremely bad name for this vital industry, for healthcare and the nation. The stream of reports published was so strong, it seemed like a procession of electoral result bulletins. Most articles cited factors such as lax laws and regulations, illegal trials, sudden deaths, inadequate compensation, and Indians being used as guinea pigs. Over-reporting by the media has led to participating subjects reporting at sites and Clinical Research Organisations (CROs) with false adverse effects, attempting to extort money and blackmail trial organisers! Without doubt, blackmail and extortion are the last things anyone would have expected. Society at large must realise that the drugs we consume have been tested not only in animals but humans too. If we claim to have become guinea pigs, let it be known that across the world millions of human subjects from different nationalities were guinea pigs for the development of the medicines that people use today. In a recently developed medical treatment for strokes, a medical device called ‘Solitaire’ has been tested in humans for clinical efficacy. Solitaire is a self-expanding stent-like design and once inserted into a clot using a thin catheter tube, it compresses and traps the clot. The clot is then removed by withdrawing the device, thus reopening the blocked blood vessel. In the first US-based clinical trials, Solitaire opened blocked vessels without causing symptomatic bleeding in or around the brain in 61 per cent of patients. It also led to better survival rates three months after a stroke. There was a
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Clinical research industry 17.2 per cent mortality rate with the new device, compared to the 38.2 per cent mortality with an earlier device. If people want such treatments to be readily available, then Indian patients would also need to participate in such medical trials, despite the mortality rate. Ultimately, participation in these trials will lead to better treatments and better healthcare.
Quality affair It is important to understand that without human trials one simply cannot have any medicines or modes of treatment that improve constantly. Any product that is introduced in any market goes through a battery of quality check points and complies with all the necessary regulations – right from development to manufacturing of the product. Regulations in India’s pharmaceutical sector and in the field of CR are as stringent as in the aviation industry. India boasts of regulations that are on par with international gold standards and are in no way inferior to those in the west. Despite the best regulations in place in any industry, however, irregularities can happen. Planes do crash, don’t they? Does this mean the entire industry is bad and should be banned or maligned? Despite rail accidents and air disasters, have we stopped travelling in trains or planes? People have missed a critical point here. While irregularities should teach stakeholders how to tighten regulations and bring about better compliance, people have instead tarnished the industry’s image via negative propaganda. The entire industry advocates adherence to the highest standards and that those guilty of contraventions should be punished under appropriate laws. In the eyes of the world this has become a point of contention, with many contesting the idea that India should be considered a destination for drug development. There are assertions and reports that investments will now move to China primarily because of regulatory delays, subjective interpretation of laws, bureaucratic issues and other hurdles.
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Unfortunately, regulatory authorities have reacted to the recent alleged irregularities by making drastic changes to guidelines or by claiming that these trials were illegal. New draft guidelines on compensation are completely lopsided and do not leave any scope but for compensating towards anything that happens to the participating subject. Such guidelines will only suit bureaucrats and not the industry. The nation seems to be reverting to the British Raj, where rules were made purely to suit the rulers! Did people ever consider the context in which the word ‘illegal’ has been bandied about? The very claim that the trials have
Society at large must realise that the drugs we consume have been tested not only in animals but humans too.
been conducted ‘illegally’ casts doubts over the functioning of regulatory authorities. The Drugs Controller General of India (DCGI) office that has powers to approve or reject trials should be empowered with authority and resources to become more effective than it is at present.
Bringing in compliance Various industry-based associations such as Association of Clinical Research Organizations (ACRO), Indian Society for Clinical Research (ISCR) and Association of BiotechnologyLed Enterprises (ABLE) have come forward and reached out to the office of the DCGI and the Ministry of Health. The approach has been to collectively bring in compliance and regulations that will protect the interests of the participating subjects as well as promote the progress of science. This is the best and most prudent way to bring about improvements and ensure that CR is conducted in the appropriate manner.
At the same time, it would be a welcome change if other stakeholders – both government and the media – reiterate their trust in the CR industry, thereby creating a positive image for it, rather than merely sensationalising any news on it. Robust support and focussed efforts from these stakeholders is all that is required presently to regain the lost glory and pride of the Indian healthcare industry. The entire industry is open minded and ready to collaborate with other stakeholders to make this happen.
An Indian perspective Analysts had projected that the total CR spending in India will increase by more than 30 per cent annually through 2010. India is now increasingly being recognised as a hub for global clinical trials as it has several prized attributes: Large and diverse patients’ pool for conducting clinical trials Availability of medical, pharmacy and science graduates Excellent infrastructure facilities Comparative cost advantage Changes in the patent laws The CR industry in India has grown from ` 20 crore to ` 100 crore during the last few years. A McKinsey report finding had suggested that the CR industry was expected to touch ` 5,000 crore by 2010 and will employ 50,000 people during the next five years. There will be a huge demand for qualified and trained CR professionals. Many pharmaceutical and CR organisations have already come forward to unlock the vast potential that India has, and are conducting clinical trials in India. (ashishdasgupta41@gmail.com )
Ashish Dasgupta Vice Chairman, Association of Clinical Research Organizations (ACRO)
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Insight & Outlook: Influenza vaccines market
Significant unmet needs GlobalData expects the influenza vaccines market to grow at a rate of 5.8 per cent, from $ 3,525 million in 2011 to $ 5,242 million in 2018. The market is set to witness moderate growth after the end of the H1N1 pandemic. 6,000
5,000
CAGR (2011-2018) 5.8%
Revenue ($ million)
4,000 CAGR (2005-2011) 7.8%
3,000
Influenza vaccines market size (2005-2010)
2,000
1,000
0 2005
2011
2018
Source: GlobalData
G
lobalData estimates that the global influenza vaccines market was valued at $ 3,525 million in 2011, and is forecast to grow at a Compounded Annual Growth Rate (CAGR) of 5.8 per cent over the next seven years, to reach $5,242 million in 2018. The moderate growth of the market is due to the increasing awareness among people about the importance of vaccination against influenza, and the approval of new influenza vaccines. The universal immunisation recommendation by the Advisory Committee on Immunization Practices (ACIP) and several government awareness vaccination programmes would help to increase the vaccination coverage for influenza.
Strong competition in the seasonal influenza vaccines market The current influenza vaccines market is primarily served by the trivalent seasonal influenza vaccines.These available vaccines are either inactivated, such as Fluarix, FluLaval,
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side effects caused by egg-based influenza vaccines, and would help to avoid situations of vaccine shortage. The pipeline for influenza vaccines is strong in terms of the number of trials being conducted for the infection. The pipeline consists of 104 vaccines, with five trials for regulatory filing and seven trials under phase III. Some of the vaccines that are launched either in the US or Europe are in the late stage development of the pipeline. The upcoming vaccines in the pipeline include universal vaccines, which would offer immunisation against multiple influenza virus strains. Also, there are ongoing trials for vaccines, which have an altered route of administration, such as oral vaccines, nasal vaccines and vaccine patches. These vaccines may further increase the compliance level for vaccinations.
Fluvirin and Fluzone, or live attenuated such as Flumist. These vaccines are efficacious in providing immunisation against virus A subtypes, H1N1, H3N2 and type B strains. They are rarely found to be associated with adverse events. Although these low priced seasonal trivalent influenza vaccines offer strong competition in the market, there is still scope for new entrants, which would offer immunisation against multiple influenza virus strains.
Significant unmet needs The annual variability of virus strains and shorter shelf life of the vaccines lead to the requirement of yearly vaccination. Along with this, the egg-based vaccines may cause allergies in some people and take a long time for production, leading to shortages when the demand is high. A vaccine which offers protection against multiple virus strains will help to address the unmet needs of the market. Also, technological advancement in the production of vaccines would reduce the
GlobalData estimated that the major markets (the US, the UK, Italy, Spain, France, Germany and Japan) for influenza vaccines grew at a CAGR of 22 per cent from 2005, to be worth $ 6,055 million in 2010. The market includes seasonal as well as pandemic influenza vaccines. Due to the H1N1 pandemic in 2009, the market for influenza vaccines witnessed a significant increase, particularly in 2009 which saw a CAGR of 112.6 per cent. The market now consists of seasonal influenza vaccines after the pandemic was declared to be over by the WHO in August 2010. In the US, several pandemic or H1N1 monovalent vaccines produced by companies such as GlaxoSmithKline, Novartis, AstraZeneca and Sanofi were used. The H1N1 pandemic influenza vaccines centrally authorized in the EU for the year 2009 were Focetria, Pandemrix and Celvapan. Arepanrix and Cell-culture Derived Influenza A (H1N1) Emulsion HA vaccine are the approved vaccines for H1N1 influenza in Japan. The market is also set to witness the launch of various seasonal as well as pandemic influenza vaccines during the forecast period. The launch of Phase III quadrivalent influenza vaccines in the coming years, such as Fluzone QIV and MEDI-3250, would offer immunisation against multiple influenza virus strains. (Courtesy: GlobalData)
Modern Pharmaceuticals I May 2012
Insight & Outlook: Access to healthcare
Need to focus on infrastructure and healthcare delivery Veterans claim that cost-based pricing in India for drugs will not work as the basic problem is access. They jointly demand that the government should stick to its draft policy to fix maximum retail price of drugs based on market-based model.
U
nlike most nations, in India there’s a general tendency to pass the buck. Over generations, this has become second nature, especially for people in positions of power or responsibility who fail to deliver. One way of passing the buck is by introducing a red herring – something that diverts attention away from the real issue. A classic case is the government’s inability to ensure universal healthcare access even 64 years after India’s Independence. Therefore, each time criticism swells about the sorry state of healthcare access, the authorities simply divert attention by introducing a red herring – high drug prices. The truth is – pricing neither drives nor hinders healthcare access. Just as there is actually no fish species called ‘red herring’, pricing being liable for the lack of healthcare
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access is an absolute myth. If pricing could propel access, India would never have had a high percentage of anaemic women – particularly since iron supplements are available for free in Primary Health Centres (PHCs) across India.
Getting to the root of the problem Clearly, pricing is not the problem. The actual issue – India suffers from lack of availability of medicines, an insufficient number of doctors or absence of healthcare personnel, and inadequate healthcare infrastructure. Even though the official policy of free supplements exists on paper, the ground reality of the other three conditions is rarely fulfilled in tandem. Even if one of the three requirements is missing – availability of supplements, doctors on duty, PHC in the vicinity – the chain is broken
and delivery of free iron supplements never occurs. India truly has lower prices compared to even other emerging countries or the developed nations. An analysis of prices of 53 drugs based on purchasing power parity revealed that India has cheaper drugs than other countries – such as Pakistan, Philippines, Malaysia, China, Thailand and Indonesia. It should be clear by now that since prices of medicines in India are amongst the lowest worldwide, pricing is not a barrier for healthcare access. In order to access medicines, India’s poor are largely reliant on the government healthcare systems represented by PHCs. But with the system plagued by inadequate infrastructure, poor availability of drugs in PHCs and shortage of doctors, nurses and pharmacists, it is these issues that need to be addressed. To elaborate, it is estimated that across India there’s a cumulative shortfall of approximately 17,000 PHCs. Due to this, patients do not have easy access to medical help, since the nearest PHC could be too far away to be reached on foot. Across PHCs in India, there is an estimated shortfall of 8,500 doctors, while 41 per cent PHCs do not have health workers. So even if patients do commute to a far-off PHC, there may be no doctor to examine them and prescribe medicines. As long as the authorities flaunt the red herring of drug prices and keep bandying drug price control as an ostensible solution, healthcare access will always remain a mirage in India. The sooner they focus on the real issues by improving and augmenting healthcare infrastructure, increasing the number of medical personnel and ensuring year-round availability of drugs, the faster will India be able to fulfil its mission of universal healthcare access.
Towards a cause Concerned about the inappropriate focus on pricing in the nation’s pharma policy, industry veterans – Daara Patel, Secretary General, Indian Drug Manufacturers Association (IDMA); Amit Bakliwal, MD, IMS Health; and Kewal Handa, MD, Pfizer India – expressed reservations about
Modern Pharmaceuticals I May 2012
Access to healthcare
To facilitate access, the government could abolish excise duties and taxes on the free medicines donated by pharma companies. Daara Patel Secretary General, IDMA
its negative impact on the industry and on efforts to boost universal healthcare access. They believe that with drug prices in India already one of the lowest worldwide, it is more important to focus on the core issues that impede access. A cost-based pharma pricing policy would be counterproductive and further hinder efforts to improve access. “Attempts to advance healthcare access via cost-based pricing miss the point that lack of infrastructure and appropriate delivery systems are needed to boost access. Moreover, Indian pharma companies have always risen to the occasion and supplied medicines free of cost to needy patients or for deserving causes. To facilitate access, the government could abolish excise duties and taxes on the free medicines donated by pharma companies,” says Daara Patel, Secretary General, IDMA. Patel highlights that the government should encourage public-private partnerships to provide universal access to healthcare, since it is not possible for public sector entities to address all the complex issues involved in improving access. Bakliwal concurred that cost-based pricing was not the proper solution to
In spite of India having a high disease burden, delivery systems have not improved in the country, impeding access. Amit Bakliwal MD, IMS Health
better access; “In spite of India having a high disease burden, delivery systems have not improved in the country, impeding access. Although affordability is part of access, individually attacking drug prices is not the solution. Given the importance of research and innovation in the pharma industry, it is necessary to strike a balance between access and innovation. We also need to understand that even having free drugs will not solve the issue of access, unless the basic problem of inadequate health infrastructure is not addressed squarely.”
Modelling an approach According to Handa, “It is not only a question of making medicines affordable, but also making them affordable in the right place for the right people. Cost-based pricing would simply not achieve this objective. Going by the state of healthcare infrastructure in India, efficient healthcare delivery is far more critical than the pricing of drugs. Furthermore, the focus is more on treating the disease rather than preventing it. Before the issue of pricing comes to the fore, it is imperative to work for ensuring that adequate medical infrastructure is
Cost-based pricing may only lead to unscrupulous manufacturers inflating input costs, while those who go by the book may find the margins unviable and thereby withdraw from certain categories. Kewal Handa MD, Pfizer India
May 2012 I Modern Pharmaceuticals
developed at a fast pace. This includes augmenting the number of doctors, nurses, midwives and auxiliary healthcare providers.”It is best to leave pricing to market forces, according to Handa, rather than trying to impose a cost-based pricing model that may finally fail, as it did in many nations, including the Philippines. The pharma veteran is also averse to the idea of treating imported drugs on par with generics. “Every nation has its unique inbuilt cost structure that takes into account aspects such as quality, research and delivery systems. Attempting to subsume diverse elements under a single price spectrum undermines competition, which underpins the spirit of competitive pricing and affordability.” He explains, “Any imported drug that’s overpriced will not survive, pricing itself out of the market. Cost-based pricing may only lead to unscrupulous manufacturers inflating input costs, while those who go by the book may find the margins unviable and thereby withdraw from certain categories. This could finally affect the quality of drugs and lead to the rise of substandard drugs that endanger the lives of patients. Such a scenario would only make the mission of universal healthcare access all the more distant,” concludes Handa. In a separate move, three industry bodies Organization of Pharmaceutical Producers of India, Indian Pharmaceutical Alliance and IDMA — have jointly demanded that the government stick to its draft policy to fix maximum retail price of drugs based on marketbased model. (spedit@infomedia18.in)
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Insight & Outlook: Peristaltic pumps
Moving beyond the labs One of the fastest-growing types of positive eristaltic displacement pumps on the market is the peristaltic is pump pump. Once used exclusively in the lab, this has been transformed for use in process control, et, many water treatment and plant production. Yet, people remain unfamiliar with this evolvingg pump technology and its advantages.
IP66 and NEMA 4X rated. Stainless steel housing and sealed keypad – apt for washdown environment – simply hose down to clean
Self-priming pump - have interchangeable pump heads that can be mounted in minutes
T
he popularity of the peristaltic pump — aka tubing pump— can be attributed to its design. An electric motor turns a set of rollers, which compress and release flexible tubing as they rotate. This squeezing action creates a vacuum that draws fluid through the tubing. Because the flexible tubing is the only wetted part, maintenance and cleanup are simple and convenient.
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This makes peristaltic pumps ideal for transferring chemically aggressive or abrasive solutions as well as highpurity fluids. Moreover, most types of pump tubing can be sterilised through autoclaving, gamma irradiation or ethylene oxide gas application, and most systems facilitate Steam-In-Place (SIP) and Clean-In-Place (CIP) techniques. This ensures complete sterility of the entire pump system with minimal cost.
Non-contamination The peristaltic pump creates a contamination-free pumping system. The fluid being pumped remains inside the tubing at all times and thus never comes in contact with any pump gears, seals, diaphragms or other moving parts. As a result, finding a pump compatible with a particular solution is as simple as choosing a chemically compatible tubing.
Simple operation Peristaltic pumps are simple to operate and easy to customise. They are selfpriming, and many models have interchangeable pump heads that can be mounted in minutes using finger-tightened screws. Engineering advances have yielded designs that allow the tubing even in large process pumps to be loaded or replaced in
Modern Pharmaceuticals I May 2012
Peristaltic pumps seconds. In addition, most pumps feature simple controls with a dial or keypad for speed control, and straightforward menus for programming more complex tasks.
Low maintenance Peristaltic pumps require little maintenance beyond tubing replacement. Tubing must be replaced periodically to off set reduced flow performance. This procedure typically takes just seconds, which can be an advantage when using the same pump to transfer or dispense different chemicals. When solutions are changed, only the tubing needs to be changed, and the pump can be up and running within minutes. In addition, many tubing pumps are designed with high an Ingress Protection (IP) rating, which means they can be hosed down for quick, thorough cleaning.
Tubing materials Peristaltic pump systems are compatible with a wide range of tubing materials, including silicone, thermoplastics, Viton and even rigid PTFE. There are also newly developed formulations of bilayer, or co-extruded tubing—such as the new Masterflex® Chem-Durance™ tubing—in which a long-life tubing
material is laid over a thinner inner material that is compatible with aggressive chemicals, resulting in a tubing whose collective properties in a pump exceed those of either material alone. Many tubing types also meet USP, FDA, USDA and/or NSF approvals. This makes peristaltic pumps suitable for handling a variety of fluids from sensitive cell cultures to industrial solvents, and allows the same pump to be used in multiple applications simply by changing the tubing.
Multimedia pumping capabilities In addition to generating enough suction to self-prime, peristaltic pumps A process tubing pump that can be easily loaded create sufficient vacuum to successfully pump most viscous fluids—including with two hands those too heavy for other types of pumps. Yet, because these pumps employ Pump application tips a gentle pumping action that leaves solid Because peristaltic pumps use flexible tubing, as the pressure inside the tube components of the fluid, including cell walls and particulates, intact, they are increases, the tube has a tendency to excellent for moving sensitive fluids, swell, pressing against the rollers and causing premature wear. To reduce slurries and suspended solids. Peristaltic pumps are also used to move wear, make sure the tubing is properly loaded in the pump head, and purchase liquids, gases and mixed-phase fluids. only quality tubing. For example, Cost-effective operation PerfectPosition™ tubing, developed Peristaltic pumps are relatively specifically for the new Masterflex® B/ inexpensive to operate. They are cost- T® process pump, is designed for high effective because flowrates and has markings printed on they are easy the surface to facilitate optimal tubing to clean, they alignment. are effectively If you are having problems with impervious to the pulsation inherent in peristaltic the most abusive, pumping, it can be reduced by using a pump-damaging pump head that has more rollers, and chemicals, and thus produces less pulsation. A pulse because the same dampener also helps. pump can be used for multiple Conclusions applications. This Peristaltic pumps have become a critical result in lower and reliable part of processes ranging labour costs, lower from chemical transfer to pharmaceutical m a i n t e n a n c e processing to wastewater treatment. costs, less Their versatility and ease of use has d o w n t i m e helped them meet a multitude of fluidand increased handling challenges. (Courtesy: Cole-Parmer) production.
High flow masterflex peristaltic pump
May 2012 I Modern Pharmaceuticals
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Insight & Outlook: Case Study - In-sight vision systems
High-speed pharmaceutical glass vial inspection Few industrial sectors have such stringent quality requirements as the pharmaceutical industry. To meet these exacting specifications, companies are increasingly utilising intelligent vision systems. A look at one such solution provided by Cognex.
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or over 30 years, EISAI Machinery GmbH, located in Cologne, Germany, has been an expert in the field of high speed pharmaceutical product testing. Its latest device, the AIM 596, can inspect delicate glass vials in fractions of a second, thanks to two Cognex In-Sight vision systems. Depending on the application and customer requirements, the machine can check approximately 6,000 packages and in its fastest version, the device, with its imposing inspection towers and star wheels, can even test up to 12,000 test units per hour.
A careful gaze In the first inspection step, the vision system, In-Sight 5600, determines the cake height of the freeze-dried contents and detects the presence of any foreign objects on their surface. At the same time, it looks for ‘splashings’ or splatters caused by unwanted boiling during the freezedrying process. A standard industrial camera then looks for foreign particles on the outside of the cake and cracks, scratches, or air pockets in the glass. These first two camera systems are attached to a semicircular bracket that moves by an oscillating drive. It is here that the In-Sight 5600 demonstrates one of its key advantages: its robustness. The injection-molded aluminum and stainless-steel housing make the In-Sight impervious to vibration stresses. Another outstanding feature of the vision system is its speed. At a standard resolution of 640
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x 480 pixels, it works at up to 60 frames per second, and in partial-scan mode, it can even reach up to 200 frames per second.
Zero tolerance for cracks With an additional In-Sight 5600 the underside of the glass vials are inspected for cracks. For freeze-dried products, the vision system also checks the vials for unwanted particles and ‘meltbacks’ (condensate residue that can arise during the freeze drying process of proteincontaining substances). In the AIM 596, EISAI developers work with the In-Sight Explorer software to create a user interface customised to the customer’s requirements. In the event of product changes, machine operators can access preconfigured files stored in an online database without problem. New test parameters are transmitted to the vision systems with just a few clicks.
A secure fit on the glass edge Before proceeding to the final test, an InSight 5400C checks both the vial cap and the flip-off seal. The inspection criteria include the checking of the presence of the parts, the colour of the cover and, for aluminum caps, the correct processing of the crimp. While the glass containers rotate 360°, the In-Sight 5400C checks that the aluminum sleeves have been fitted completely around the edge of the glass and the stoppers are tightly inserted.
The second inspection tower of the EISAI SD system checks liquid products for the presence of foreign particles. The rotating containers are stopped abruptly, leaving the liquid in rotation. In the middle of the glass vials, the liquid rotates rapidly and rises while, to the outside, its speed is slower and it sinks. This would cause a particle to pass through the inspection area several times. To check for particles, a focussed halogen light beam illuminates the glass vials and strikes a photo sensor.
Error-free sorting After exiting the test stations, the glass vials are conveyed by star wheel to the final sorting station. Defective products are sorted into various trays, depending on the nature of the defect. Products that pass the testing process are forwarded to a labelling or packaging machine. Then only the glass vials with 100 per cent product quality enter the pharmaceutical wholesale chain
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Case Study - In-sight vision systems and are distributed to clinics, pharmacies and medical practices worldwide. Other conventional ways of testing the vials To identify any foreign particles, dust, glass particle, small creatures etc. in bottle/vial after washing process To check body cracks or any physical damage To check filling level of liquid or powder in bottle/vial To check presence/absence of cap/seal on vial and also to check position of cap To verify presence/absence of the label on bottle/bial To verify label pattern matching and colour matching To check and verify barcode. These barcodes contain the detail of the product like batch no, MRP , manufacturing date, expiry date, etc
Other products in the same category Pharma sector has stringent quality requirements. To meet these exacting specifications, companies are increasingly
May 2012 I Modern Pharmaceuticals
utilising intelligent vision systems. Cognex offers to provide solutions to these pharma sector companies with a range of products depending on requirements. Some are: Insight 5400 with track and trace software for traceability; Cognex In-Sight 5605速 5MP is a small, but critical component used extensively in the serialisation solution, not only to validate the presence, accuracy and readability of the various labels, but also to ensure product safety and package integrity etc.
Market for In-Sight 5600 Market for all vision system is based on application and the product to be inspected. Before installation of products, the exact requirement is to be understood and thorough study of the application and production facility. In-Sight 5600 is based on high speed performance, and its robust application. Hence, it can be used in different applications in different verticals.
Services offered Cognex products are very easy to integrate and use. Though these products
are installed in production units, there is not much wear and tear involved of these products. Therefore after sales service is not a major concern. If proper training is given to the staff, even shop floor engineering can set up the program. While in case of an emergency, application engineers are always there to provide support with immediate response. Cognex is the only vision-based company in world, which has integrated more than 6,00,000 systems. Companies around world rely on Cognex vision system to enhance quality, optimise product quality and drive down production cost. (didier.lacroix@cognex.com)
Didier Lacroix Global Senior VP (Sales & Marketing), Cognex Inc
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Automation Trends: Robotics and lab automation for drug discovery
When
future becomes the
present!
The process of drug discovery has reached the next level where automation is playing an equally crucial role like the scientists. Robots, advanced processes and software for assay development, solutions for ďŹ nding the target and selection, and automation today have an important role to play in drug discovery.
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hat should automation be, friend, philosopher, guide or a slave? Of course most of us would want it to be all of them and more, but the reality is that even with the most marvelous technologies of the 21st century, automation is still inching towards being a good slave. The next question is what should automation deliver? Time, precision, more sensitivity, productivity, speed, control, cost saving. Letting users decide would mean all of
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the above and also serve coffee, reality is that with every choice you make you have to give up something. Increase in speed mostly reduces sensitivity, with precision you sacrifice range. Before this article becomes philosophical and unworthy of attention, let us move on to the next question. What should scientists actually do, design experiments or conduct experiments? One thing is obvious is the lack of thinking power of machines, they are incapable of thinking like scientists. Letting scientist free to
think and let automation do the boring and mundane tasks is the way to do it, and that is the way it has been. One thing is clear that automation will never design experiments or think for us it’s easier to look at them as just tools and not like magic wands.
Automation and drug discovery Drug discovery scientists have a problem that is symptomatic of the current century - the deluge of data. Their’s is a process of elimination and selection that takes up almost as long as their love affair with the selected. The drug discovery process involves mainly identifying a target, Absorption, Distribution, Metabolism, and Excretion (ADME) studies, clinical trails leading to a commercial drug. The story of any drug from the lab to the store
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Robotics and lab automation for drug discovery would be filled with difficult choices made, high risk decisions, big leaps of faith, laced with personalities and technologies. Here is the continuing story of the role automation and technology played over the years in the drama of drug discovery. Finding a target: Having successfully sequenced the genome of the mice, men and other organisms, has led to the science of understanding the sequences and making sense of the genetic data (genomics) and at the next level understanding the way the living cell functions (proteomics). All these processes lead to a large number of targets that need to be screened for its potential to become the next drug. Sheer size of targets lends itself to automation as traditional methods would take to long to take advantage of the data. So the solution is High throughput screening (HTS). High throughput screening: Widely used in the pharmaceutical industry, HTS is a process of quickly understanding the activity of a large number of drugs like compounds, the objective is to identify ligands, ion channels or other pharmacological targets or find pathways of interest. Usually done in microtiter plates, this process lends itself to a lot of automation, IT uses, robotics, liquid handling, data processing, control software and sensitive detectors. The automation available includes simple semi-automated liquid handling devices to pipetting stations, integrated with incubators plate washers and readers. Large corporations look at complete automated solutions where compound libraries are automated with robotics for pick and placing samples, with barcode readers ensuring traceability. Assay development is completely automated with nano litre dispensers stepping in to optimise on the small volumes of precious compounds that drug discovery scientists work with. With the level of automation currently available it is possible to have work stations that can pipette and deliver small volumes into plates or any vessels within 24 hours a day throughout the year. This enables scientists to focus on science and let the machine do the routine tasks.
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ADME: Once the scientist is done with the screening and has found a target that he wants to spend time and energy on the next steps are to figure out how the target fares in the pharmacological and toxicity tests. These series of studies known as ADME, try to figure out how the target candidate behaves within the organism, its absorption, distribution, metabolism and elimination characteristics. As scientists seek more complex answers on the targets, these studies include among others, toxicokinetics, pharmacokinetics/absolute bioavailability in toxicology species, protein binding, metabolite profile, pharmacodynamics, etc, these could be both invitro and invivo studies; all these studies have large scale automation that assist scientists in seeking reliable answers in quick time. Some of the other automation available for ADME studies include, automated cell permeability workstation, in-silico screening, software for prediction of ADME properties based on chemical structure, etc, Nuclear Magnetic Resonance (NMR) is also used to identify functional groups in the target drug. The current trend is to move to systems that can do everything in molecular biology, DNA extraction, RNA extraction, and proteomics, all based on the same platform and software. Multiplexing: Assaying is complicated when you study it at the cellular level; the way the compounds behave is dependent to a large extent on the cellular environment they find themselves in. As in an assay an evoked response can trigger a reaction in a cell next to it, its efficient for scientists to screen for several target molecules in the same reaction vessel. To do this researchers have developed what is called as multiplexed assays. These involve using multiple tags and advanced image detection systems to spot effects simultaneously.
imaging. Knowledge of biochemistry, cell biology, physiology leads to development of tools to study living cells using images acquired from imaging systems. Some of the techniques and technologies available are Fluorescence Tomography (FMT), live cell imaging, Fluorescence Resonance Energy Transfer (FRET) for studying interaction between molecules, Fluorescencein Situ Hybridisation (FISH) is a powerful technique for detecting RNA or DNA sequences in cells, tissues and tumours, etc.
Making automation pay How to efficiently use automation and how to standardise it across the entire process is the question everyone has to ask when one decides to automate. There are too many platforms competing in the marketplace, each offering a specific solution, the challenge is to seamlessly integrate them all. It is critical to pick an architecture platform that is flexible and is upgradeable and is modular, so that nothing you invest in becomes redundant too early. Different equipment throwing up data in different formats and the task of integrating them and making sense of it is a challenge. It is never about what automation does to you, it is always about what you do with automation. As it is evident, automation is best utilised only after understanding ones needs, understanding the limitations of the solution, being aware of the skills one needs to develop to use it. And most importantly understanding how the process is impacted if one implements automation to a part of the process. After all a chain is as strong as its weakest link. (bhanu@automedsystems.com)
Emerging trends The need to understand biology of interest as it functions in normal physiological context is becoming increasingly important and this need of scientists had led to the emergence of various instruments and reagents for live cell
Bhanu Prakash MD & CEO, Automed Systems Pvt Ltd
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Energy Management: Waste management
No haste while disposing waste With waste management gaining relevance it is the apt time for pharma companies to consider this as a priority. A look at the how’s and why’s of waste management procedure.
laboratory chemicals found in healthcare settings. Pande says, “Drug formulations that exhibit one of the characteristic of hazardous wastes including ignitability, corrosivity, toxicity or reactivity must also be managed as hazardous waste if discarded. These management procedures include proper identification, storage, manifesting, transport and disposal at a RCRA approved incineration facility.”
What needs to be done? Chandreyee Bhaumik
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ariety of chemicals are drained off from the waste discarded from hospitals and pharmaceutical companies. The discovery of a variety of chemicals in surface, ground, and drinking water is not a rare sight anymore. It raises concerns around the country regarding the potentially adverse environmental consequences of these contaminants. Various reports show that minute concentrations of chemicals known as endocrine disruptors, some of which are pharmaceuticals, have detrimental effects on aquatic species and possibly on human health and development. Talking about the concerns, Shruti Pande, Global Clinical Team Lead, Wockhardt Ltd, elaborates, “The pharma industry has been concerned about the environmental presence of hazardous pharma compounds and the potential risks including reproductive impairment, increased incidences of cancer, the development of antibiotic-resistant bacteria, and the potential increased toxicity of chemical mixtures.” She adds, “For many substances, the potential effects on humans and aquatic ecosystems are
not clearly understood. The increasing awareness of the harmful effects of these compounds has prompted development of numerous publications of the risks and consumer guidance from state agencies on proper disposal of unused medications, and guidance from the Environmental Protection Agency (EPA) on use and disposal of pharmaceuticals.”
Resource Conservation and Recovery Act The US EPA Resource Conservation and Recovery Act (RCRA) regulates the disposal of solid waste and includes numerous definitions of hazardous chemical waste. A number of common pharmaceuticals, such as epinephrine and warfarin, are listed as acutely hazardous wastes on the P-list published in 40 CFR 262.33 (e) A number of chemotherapy items and other drugs such as lindane are listed on the U-list of chemicals found at 40 CFR 262.33 (f ) If a P or U listed drug is the sole active ingredient when discarded, the item is designated as a hazardous chemical waste and must be managed in compliance with RCRA,similar to discarded Xylene or other
Pharma companies should apply green chemistry principles in R&D and manufacturing and explore means to recover or recycle solvents. Shruti Pande Global Clinical Team Lead, Wockhardt Ltd
Every pharma company should commit to certain goals for waste management. Pande lists them out as: Phase out Class I ozone depleting compounds (ODCs) in large Heating, Ventilation and Air Conditioning (HVAC), fire suppression and industrial process equipment Continue reducing the ozone depletion potential from releases of ODCs Decrease the waste that is produced by improving recycling, reuse and recovery methods Prevent soil and groundwater contamination at facilities and those owned by contractors hired to manage waste She avers, “Pharma companies should apply green chemistry principles in R&D and manufacturing and explore means to recover or recycle solvents.” She adds that the pharma companies need to develop action plans in order to capitalise on waste minimisation opportunities. She highlights, “Supporting waste reduction efforts by suppliers and contractors through the use of recycled, reusable and recovered materials is an important activity. The pharma companies should exclusively use approved special waste vendors. Conducting pre-selection and periodic follow-up audits of waste vendors to assure standards are mandatory steps.” Signing off Pande says, “Addressing contamination at sites and conducting onsite remediation activities with appropriate government disclosure and co-operation is very important for maintaining waste in a pharma facility.” Thus, waste management is not a cumbersome process but simply implies compliance to certain rules and regulations. (chandreyee.bhaumik@infomedia18.in)
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Policies & Regulations: Impact of National Pharmaceutical Pricing Policy Draft 2011
W n some, l se some
(FDA) approved manufacturing facilities in the world outside the US it is recognised world over as a reliable source of quality medicines at affordable prices. This remarkable progress was achieved due to several factors. Outstanding leadership of India’s entrepreneurs and scientists, reducing the span of price control from 370 to 74 drugs in a phased manner over the past three decades, lack of product patent, which enabled Indian companies to reverse engineer original research molecules of MNCs, are some of the primary drivers among many, for the growth of this dynamic industry. The pharmaceutical scenario in the country has however undergone a sea change following the enactment of product patent law in 2005, and the industry is now moving from imitation to innovation. Ranbaxy, for instance has recently announced its anti-malarial drug discovered for the first time in India. Many more new drugs are awaiting completion of clinical trials. How does then the National Pharmaceutical Pricing policy 2011 fit in this new scenario. Like most half-baked government policies, NPP 2011 will hardly have any positive impact on access to medicines and healthcare of the nation. What we need is a comprehensive healthcare policy and not a piece-meal approach. No wonder the Department of Pharmaceuticals is having a second thought on implementing NPP 2011. Following are some of the factors we need to consider before embarking on drug price control.
Genesis of NPP With almost 80 per cent of healthcare cost falling outside the price control ambit, imposing a price control on drugs will not lead India to become a healthy economy. Focus on healhtcare infrastructure and delivery is a must, which means we need a comprehensive healthcare policy.
T
he Indian pharmaceutical industry has made a phenomenal progress in the past few years. It has crossed $ 21 billion in sales, domestic and export
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combined in 2011, both growing at double digits. With highest number of Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) and US Food and Drug Administration
It is often justified that the drug policy is the outcome of the Supreme Court judgment which urged the government to consider appropriate criteria to ensure that essential and life saving drugs do not fall outside the preview of price control. Since when did government start honouring the Supreme Court judgments? With a prospect of losing ` 10,000 crore in taxes, not only it reversed the Supreme Court judgment and rejection of its review petition in Vodafone IT case but amended the IT rules that too retroactively from 1962 to suit its
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Impact of National Pharmaceutical Pricing Policy Draft 2011 objective. This is not to suggest that the government should not honour judgments by the Supreme Court, but it should come out with a policy that benefits the patients and also balances it with the viability of the industry. There is a mistaken belief that currently only 74 drugs are under price control. The fact is the drugs which are not under price control have a cap of 10 per cent price increase per year. Is not this a hundred percent price control, particularly when inflation is hovering around double digit?
Access to medicines The key challenge that we face today is access to medicines and not their prices. Not only drugs produced in India are priced lower than BRICS (Brazil, Russia, India, China and South Africa) countries but our prices are lower than even neighbouring countries such as Pakistan, Bangladesh and Sri Lanka. According to the World Health Organization (WHO) and many internal reports, access to medicines in India is less than 40 per cent, one of the lowest among the developing countries. This low access is not because of availability or high prices of medicines but because of poor health infrastructure where there are no or poor diagnostic facilities, doctors, hospitals, pharmacies, etc in the interior. Focusing on prices alone will not solve this issue. Over 80 per cent of healthcare cost falls outside the price control ambit. For instance, pathological and other diagnostic tests, doctors’ fees, hospital stay, etc are outside the purview of price control.
under decontrolled category is given 20 per cent retailers margin, it amounts to ` 2/- margin in absolute terms. However a product costing say ` 1000/- per unit dose (Eg: erythropoetin injection) will yield ` 200 /- to the retailer at 20 per cent margin, which is much too high. Hence, there should be a slab-based structure with reduced percentage margin as the product price becomes high.
Prevention better than cure A developing country like India should deploy its limited resources to prevention rather than cure. This includes vaccination, immunisation, sanitation, hygiene, clean drinking water, cessation of bad habits such as tobacco chewing/smoking, safe sex habits, nutrition, exercise, environmental pollution and behavioural changes
Focusing on prices alone will not solve this issue. Over 80 per cent of healthcare cost falls outside the price control ambit.
through awareness building. India has successfully eradicated polio from its soil due to abundant availability of oral polio vaccine and building awareness through active promotion.
Reducing transaction costs
Health insurance
One way of reducing the prices of medicines is to reduce the transaction costs which amounts to about 40 per cent, one of the highest in the world. This includes taxes such as VAT, customs and excise duties, local taxes such as octroi, distributors and retailers` margins, etc. Instead of having uniform margins for distributors and retailers across all products, it should have a slab-based structure, with reducing margins as the product price goes up. Suppose a product costing ` 10 per strip
Over 80 per cent of our population pays from its own pocket for medicines and there lies the problem that needs immediate attention. We need to expand the health insurance sector by attracting foreign capital and expertise and promoting our own insurance schemes like Rashtriya Swasthya Beema Yojana. Foreign capital in insurance will be difficult to attract unless equity participation is increased from present 26 per cent to at least 49 per cent, a proposal waiting for a long time.
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Increased healthcare budget India’s defense budget for 2011-12 is ` 1,64,415 crore, which perhaps is justified given our ‘friendly’ neighbourhood. However, this does not justify spending meager ` 26,780 crore per year on healthcare, which is less than 1 per cent of our Gross Domestic Product (GDP) (bailout package announced recently for Air India is ` 30,000 crore with almost zero prospect of getting this tax payer’s money back from the borrower). Most developed countries spend over 12 – 14 per cent of their GDP on healthcare. India needs to increase the budget to at least to 4-5 per cent of GDP to make any meaningful impact on healthcare. In spite of deficiencies in execution of several government policies and delivery mechanism, several heath indicators, like child mortality, life expectancy, birth rate, etc are showing improvement, largely because of abundant availability of good quality drugs at affordable prices. The Indian pharmaceutical industry needs to be commended for this contribution and not penalised by inflicting illogical price controls on its produce. Pharmaceutical business is increasingly becoming complex and knowledge & innovation intensive. It requires significant investment for compliance with Good Manufacturing Practice (GMP), quality and safety, as well as R&D for discovering new drugs, technology up gradation, continuous medical education, Intellectual Property Rights (IPR), etc. By imposing such irrational price controls, the industry that cures sickness will itself head towards sickness. Price control for medicines is a remedy worse than the disease. (avdangi@gmail.com)
Dr Ajit Dangi President & CEO, Danssen Consulting
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Strategy: Proximity dilemma
To wish or not to wish?
S
ituations wherein doctors are in an emergency room and are stopped by MRs or people calling on their cell phones for their birthdays/ anniversaries are being played out in numerous clinics across the country. Most pharmaceutical companies have procured all kinds of personal data from doctors. The company’s staff is well aware of the birthday, anniversary, names of spouse, children, everyone’s interests, hobbies, tastes, their choices for touring and holidays undertaken, etc.
While some doctors’ details were obtained by MRs themselves during their calls, data from other physicians were extracted surreptitiously under the guise of filling up forms for conference registration, CME society membership, doctors’ club membership, etc. Most busy physicians ‘outsource’ these formfilling exercises to the ever-obliging MRs by scribbling their personal information on their prescription pads. The MR later transcribes these details on the forms. In the process they get access to personal data. With the MR
Making a sales pitch by gifting doctors on their personal achievements is not considered a great marketing tool. It can work contrary to expectation in case the doctor in question considers it an intrusion into his private domain. An assessment of the situation. having eased the physician burden, the latter would be in no position to complain about ‘date theft!’ Moreover how can one be rude when you wish them on an important day like a wedding anniversary? It surely is a catch-22 situation for the doctor! While young physicians may initially enjoy the attention, in private many senior physicians find it objectionable to be interrupted while at work even it is to accept greetings on a personal event. However, not many are able to express it clearly for fear of appearing rude and insensitive.
Embarrassment awaited
Illustration: Sachin Bhogate
Imagine the physician’s predicament with a waiting room full of patients humorously notice a queue of MRs holding cakes, gifts and bouquets! Patients often enquire with the clinic staff about the exaggerated interest among MRs on that particular day. Most physicians who would like to treat their personal occasions as ‘private’ are forced to accept greetings from a dozen patients that day. Physicians, who normally keep their conversation limited to the patient’s health status and see more patients in a limited time, may be compelled by the latter to disclose what he or she is celebrating that day! The consultation which is supposed to be a serious clinical discussion sometimes veers around to how Sagittarians are all alike!
This one takes the cake! In Mumbai, a young consultant had an uncomfortable situation to face on his 32nd birthday. That noon while he was busy in his consulting room seeing patients, an MR secretly landed at his residence holding a large black forest cake, in the presence of the doctor’s relatives who were invited for lunch. The guests
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Proximity dilemma expressed their surprise to the doctor’s wife that “We did not know that pharmaceutical companies do this, as well,” while she tried to hide her embarrassed expression. No sooner had the physician landed home the discussion switched to cut the ‘pharmaceutical cake.’ Promptly his teenaged niece enquired, “And what else do they provide, uncle?” Needless to say, the humiliated physician called up the Manager, the very next day, and asked him to desist from such practices in future.
Too close for comfort All industries in the service sector have their own techniques to promote their sales. One of the oldest tactics is to pamper the people involved by celebrating their personal events. Wishing someone on their birthdays, anniversaries, success etc. is a common behaviour of human beings. Making telephone calls, sending messages or gifts is a common practice among all professions. Physicians and their families too celebrate these special occasions by enjoying a meal outside or having a feast with relatives. In most cases, physicians who are hard-pressed for time reserve these moments to be spent with their families. As they grow senior in practice, gifts and mementoes do not provide any special sense of pleasure. Many of them are embarrassed to reveal their age or accept greetings. In such a scenario, a hall full of gift-bearing sales representatives is sure to get his goat! What is worse for the doctor is that the ‘celebratory’ MRs wait in the midst of suffering patients who are eager to finish off their consultation and rush back home.
Excuse me, please! Fed up with this practice by pharmaceutical companies, despite his resentment on such activities, a senior consultant has notified his receptionist to mark the day as a ‘No MRs day’ on his birthdays and anniversaries. Persistent MRs still manage to sneak in when a patient leaves the cabin and just push a rose or a pen to the doctor even before the receptionist can react. A senior physician who celebrated his golden jubilee recently wanted to ensure that it was a purely private affair. He provided a readymade placard to the receptionist with the words, ‘Thank you for your good wishes. Please respect clinic rules and excuse meeting me today!’ Every method adopted by sales personnel is considered a winning idea till others copy and make it overkill. The pharmaceutical industry should try out more innovative plans to get the doctor’s undivided attention. Till then, it is wise not to get too close to the doctor with such old strategies; you may be unknowingly stepping on his toes! (rajan.td@gmail.com)
Dr Rajan T D Pharma Consultant & Practising Dermatologist May 2012 I Modern Pharmaceuticals
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Tips & Tricks: Pre-grant oppositions
Knowing the nuances
P
atent invalidation, under the Patents Act, 1970, can be initiated whereby a person or a party referred to as opponent may oppose a patent application before grant of patent or oppose a granted patent. The opposition proceedings before the
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Filing a pre-grant opposition: Representation for opposition can be filed within six months from the date of publication of application as the Patent Rules prohibit grant of a patent before the expiry of a period of six months from the date of publication of the application. There is no prescribed form or fee but consideration of a representation is possible only if the Request for Examination (RFE) has been filed for the application to be opposed.
Tips& Tricks
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Who can file: ‘Any person’ by way of representation, in writing, can file a pre-grant opposition after publication of the application (in the Patent Office Journal) till the grant of the patent. The term ‘any person’, as judicially held, is to be construed in the context of wider rights given to the objector, s the concept of Lis is wide under pre-grant opposition.
Tips& Tricks
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Novelty - Absolute vs Relative: An examination of a patent application is based on the principal of ‘absolute’ novelty in terms of prior use; however, the ground of novelty on which third parties or persons interested can oppose a patent application limits the right of the opponent to oppose only on the ground of ‘prior public use’ in India and not elsewhere, ie ‘relative’ novelty.
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grant of a patent are referred to as pre-grant opposition. It is a peerinitiated challenge mechanism, which is administrative in nature (before the Patent Controller) and not judicial, giving an opportunity to a competitor/ interest group to oppose unjustified protective rights.
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Obviousness: When ips dealing with obviousness, ricks it is permissible to make a ‘mosaic’ out of the relevant documents, but it must be a ‘mosaic’, which can be put together by a person ordinarily skilled in the art.
T&
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Section 3(d): The test of patent eligibility under section 3(d), in context of pharmaceutical inventions, requires comparative data to ascertain the difference in properties with regard to efficacy between a derivative and its parent compound. It is known statutorily that the mere discovery of a new form of a known substance, which does not result in enhancement of known efficacy, will not be treated as an invention. The application should show that the derivative of the known substance has a significantly different therapeutic effect.
Tips& Tricks
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Procedure: The opposition proceeding is time-bound and quick therefore before triggering any pre-grant opposition, it is always advisable to prepare the statement and evidence in support of the representation very thoroughly.
Tips& Tricks
Kamakhya Srivastava Head-Group on Research Publication and Programme, LEX ORBIS IP Practice
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Appeal: An appeal from the Controller’s decision, in a pre-grant opposition, does not lie under the statute but there are now a chain of case laws under which it has been judicially determined that a pre-grant opposition is in ‘aid of examination’, hence the Controller’s decision is under section 15 of the Patents Act and can be appealed against before the Intellectual Property Appellate Board.
Tips& Tricks
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Patent watch: A patent application having a bearing on any in-house patent/ patent application or product portfolio may be seen to determine if there is any prior art that would invalidate the patent that the patent office had not previously considered. If said prior art is discovered, the company may bring an opposition proceeding to have the patent declared invalid.
Tips& Tricks
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Business strategy: The current crop of pregrant opposition cases is evidence enough that generic companies are using it as a business strategy. Integrate the pre-grant opposition in a comprehensive IPR Management System to capture, evaluate and prioritise inventions in the process of IP creation, accelerating innovation, evaluating IP assets and accessing the business direction of competitors.
Tips& Tricks
Modern Pharmaceuticals I May 2012
Projects
New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry.
Alembic Pharmaceuticals Ltd Project type New facility Project news Alembic Pharmaceuticals Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of Diene. Project location Panchamahal, Gujarat Project cost Unknown Implementation stage Construction Contact details: Alembic Ltd Alembic Road Vadodara - 390 003 Gujarat Tel: 0265-2280880 Fax: 0265-2281508 Email: infoal@alembic.co.in --------------------------------------
Blue Ocean Biotech Pvt Ltd Project type New facility Project news Blue Ocean Biotech Pvt Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of liquid glucose. Project location East Godavari, Andhra Pradesh Project cost Unknown Implementation stage Construction
East Godavari Andhra Pradesh – 533440 Tel: 0884-2329034 Email: info@blueoceanbiotech.com ------------------------------------
Capsugel Healthcare Ltd Project type New facility Project news Capsugel Healthcare Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of Vcaps Hpmc (Hypromellosed) capsules. The company received industrial license from Secretariat of Industrial Assistance (SIA), Department of Industrial Policy and Promotion, Government of India for setting up the project.
May 2012 I Modern Pharmaceuticals
Project location Ahmedabad, Gujarat Project cost Unknown Implementation stage Construction Contact details: Claris Corporate Headquarters Nr. Parimal Crossing Ellisbridge Ahmedabad - 380 006 Tel: 079-26563331 Email: investorservices.corp@ clarislifesciences.com -------------------------------------
Exemed Pharmaceuticals Project location Rewari, Haryana Project cost Unknown Implementation stage Construction Contact details: Capsugel Healthcare Ltd 21, Joniawas Dharuhera Rewari Haryana – 122100 Tel: 012-7426 7092 Fax: 012-7426 7168 Email: CapsugelCommunications@ Capsugel.com -------------------------------------
Claris Lifesciences Ltd Contact details: Blue Ocean Biotech Pvt Ltd 4-325, G Ragampet Peddapuram Mandal
set up a new pharmaceutical project. It involves manufacturing of large volume parenterals.
Project type New facility Project news Claris Lifesciences Ltd is planning to
Project type New facility Project news Exemed Pharmaceuticals is planning to set up a new pharmaceuticals project. The project involves manufacturing of tramadol hydrochloride. Project location Vadodara Project cost Unknown Implementation stage Construction Contact details: Exemed Pharmaceuticals 628 A and B, ECP Canal Road At. and Po. Luna Taluka - Padra Vadodara Gujarat Tel: +91 9662536756, +91 9662536757 Email: info@exemedpharma.com -------------------------------------
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Projects
Lupin
Unique Biotech Ltd
Torrent Pharmaceutical Ltd
Project type New facility Project news Lupin is setting up a new manufacturing plant at the MIHAN Special Economic Zone (SEZ).
Project type New facility Project news Unique Biotech Ltd is planning to set up a new pharmaceuticals project. The project involves probioticsmicroorganisms probiotic formulations.
Project type New facility Project news To r re n t Pharmaceutical is going to expand its facility at Kadi and will be setting up a green field project at upcoming Dahej SEZ.
Project location Nagpur Project cost ` 400 crore Implementation stage Construction Contact details: Lupin Ltd B/4 Laxmi Towers Bandra Kurla Complex, Bandra (E) Mumbai 400 051 Tel: 022- 6640 2222 Fax: 022- 6640 2130 Email: info@lupinworld.com -------------------------------------
Sandoz Project type New facility Project news Sandoz, has set up a pharmaceutical formulation facility. This is Sandoz’s first large scale facility in Asia. The facility has been built as per US and European standards and is dedicated to these markets.
Project location Rangareddy in Andhra Pradesh Project cost Unknown Implementation stage Construction Contact details: Unique Biotech Ltd Plot–2,Phase -2 Alexandria Knowledge Park. Genome Valley, Shameerpet Hyderabad – 500078 Andhra Pradesh Tel: 040-23480 346/47 Fax: 040-23751 345 Email: info@uniquebiotech.com --------------------------------------
Wockhardt
Project location Mumbai Project cost $13 million Implementation stage Complete
Project type New facility Project news Wockhardt has set up a 28,000sqm global-scale biopharmaceuticals manufacturing biotech complex. Project location Aurangabad Project cost Unknown Implementation stage Complete
Contact details: Sandoz Plot Nos. D-31 & D-32, MIDC TTC Industrial Area Turbhe Navi Mumbai - 400 705 Tel: 022-5591 0485 Fax: 022-5591 0472 Email: info.sandoz@sandoz.com ---------------------------------------
Contact details: Wockhardt Towers, Bandra-Kurla Complex, Bandra (East) Mumbai - 400051 Maharashtra Tel: 022-26534444 Fax: 022-26534242 Email: investorrelations@wockhardt.com --------------------------------------
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Project location Kadi, Mehsana district Project cost ` 300 crore Implementation stage Construction Contact details: Torrent Pharmaceutical Ltd Off Ashram Road Ahmedabad- 380009 Gujarat Tel: 079-26585090 Fax: 079-26582100 Email: trc@torrentphara.com --------------------------------------
Hyacinths Pharma Pvt Ltd Project type New facility Project news Hyacinths Pharma Pvt Ltd is planning to set up a new project that would involve manufacturing of ethambutal. Project location Srikakulam, Andhra Pradesh Project cost Unknown Implementation stage Construction Contact details: Hyacinths Pharma Pvt Ltd H. No 8-3-678/60 Yousufguda Hyderabad: 500045 Andhra Pradesh Fax: 040-23756566 Email: hyacinthspharma@gmail.com --------------------------------------
Modern Pharmaceuticals I May 2012
Event List
NATIONAL AHMEDABAD
PUNE
CHENNAI
LUDHIANA
Gujarat, Oct 5-8, 2012
Maharashtra, Nov 2-5, 2012
Tamil Nadu, Nov 22-25, 2012
Punjab, Dec 21-24, 2012
INDORE
AURANGABAD
RUDRAPUR
Madhya Pradesh, Jan 11-14, 2013
Maharashtra, Feb 1-4, 2013
Uttarakhand, Feb 23-26, 2013
India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, 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
Lab Expo & Conferences Coimbatore This event focusses on various aspects related to lab equipment manufacturing as well as promoting good lab practices among the fellow professionals. The trade show will be a two-day affair and will witness attendance from a considerable number of professionals who have been involved with this profession for a long time. This expo will also be supplemented with informative sessions and workshops. This is an excellent platform for the lab equipment manufacturers and distributors to display their latest technological innovations and creations in front of an international audience. Moreover, this event also takes care of a number of important issues related to lab automation and labware equipment; June 15-17, 2012, Codissia Intec Technology Centre, Coimbatore For details contact: Paramount Exhibitors Tel: +91 172 2274801 Fax: +91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com
Pharma Rural Marketing 2012 This is one of the dedicated platforms that will bring together senior level decision makers from across marketing and strategic planning functions within the Indian pharmaceutical industry. During these action packed three days, with high value networking and business content, Indian and multinational May 2012 I Modern Pharmaceuticals
pharma companies, marketing consultants, communication agencies, supply chain and logistics management companies will identify the key challenges within the industry and discover business critical solutions to overcome them; June 21-22, 2012, Holiday Inn, 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
Automation 2012 All leading companies in industry will showcase their latest products and help one find the solutions at the show. The show brings latest technologies from an interesting array of fields such as: factory automation, process automation and control systems, robotics & drives, field instrumentation & smart sensors bus technologies, software solutions, wireless technolog y, building automation, and hydraulic & pneumatic automation in renewable energy. From technocrats to solution providers, vendors and tech-buffs, the fair is all set to draw every one alike; September 7-10, 2012, NSE Complex, Mumbai For details contact: IED Communications Pvt Ltd Tel: + 91 22 22079567 Fax: + 91 22 22074516
Email: arokiaswamy@iedcommunications.com Website: www.iedcommunications.com
Pharmac India It is a-three-day event that aims towards highlighting several issues of the industry. This will be large hub of reputed professionals from pharma formulation, herbal products, veterinary drug, medical & disposal, pharma machinery and many other sectors. There will be visitors from pharma company marketing/purchase/ export executive, marketing company & consultant, merchant exporters, contract manufacturers, pharma distributors, generic & OTC manufacturer & wholesalers, Government supplier, liaison agents, sourcing companies, production & purchase professionals, and international business representatives; September 8-10, 2012, Gujarat University Exhibition Hall, Ahmedabad For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91-22-24102801 Fax:+91-22- 24102805 Email: ramesh.v@orbitexhibitions.com Wewww.orbitzexhibitions.com
Indian Lab Automation conference and exhibition ILA 2012 will feature three technical conference tracks; Drug Discovery and Development, Advances in Bioanalysis and Advances in Genomics and Informatics. Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai For details contact: Select Biosciences Ltd Tel: +44 1787 315110 Fax: +44 1787 315111 Email: enquiries@selectbiosciences.com Website: www.selectbiosciences.com
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Event List
INTERNATIONAL Biomarkers World Europe This event aims to discuss how to support target identification and eliminate dead-end candidates, to understand the range of biomarker candidates, how to create sophisticated animal models of human disease to develop biomarkers for proof-of pharmacology, how to facilitate clinical trial stratification and employ early surrogate end points of efficacy, ways to define the correlation between biomarker and disease/therapeutic inter vention; May 22-24, 2012, Business Design Centre, London, UK For details contact: Health Network Communications Ltd Tel: +44 0 207 608 7055 Fax: +44 0 207 608 7050 Email: skhamissa@ healthnetworkcommunications.com Website: www.healthnetworkcommunications.com
Conference on Social Media in the Pharmaceutical Industry This event aims to focus on keeping the audience up-to-date with developments in the ever-changing social media sphere. With this industry moving at a rapid pace, and with more patients and healthcare professionals becoming more tech-savvy, the pharmaceuticals industry need to embrace social media; July 9-10, 2012, Copthorne Tara Hotel, London, UK For details contact: SMi Group Ltd Tel: +44 0 20 7827 6000 Fax: +44 0 20 7827 6001 Email: client_services@smi-online.co.uk Website: www.smi-online.co.uk
ICBLS 2012 The aim of the International Conference on Biological and Life Sciences (ICBLS)
conference is to provide a forum for laying the foundations of a new principled approach to Biological and Life Sciences. To this end, the meeting aims to attract participants with different backgrounds, to foster crosspollination between different research fields, and to expose and discuss innovative theories, frameworks, methodologies, tools, and applications; July 23-24, 2012, River View Hotel, Singapore For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society (APCBEES) Tel: +852 3069 7291 Fax: +852 2180 1366 Email: icbls@cbees.org Website: www.icbls.org
JCBBB 2012 The 3rd Journal Conference on Bioscience, Biochemistry and Bioinformatics ( JCBBB 2012) aims to provide a forum for researchers, practitioners, and professionals from the industry, academia and government to discourse on research and development, professional practice in bioscience, biochemistry and bioinformatics. This is one of the leading international conferences for presenting novel and fundamental advances in the fields of bioscience, biochemistry and bioinformatics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving bioscience, biochemistry and bioinformatics related techniques; September 1-2, 2012, Phuket, Thailand For details contact: International Journal of Bioscience, Biochemistry and Bioinformatics Tel: +91 422 2611146 Fax: +91 422 2611043 Email: ijbbb@vip.163.com Website: www.ijbbb.org
NCCR 2012 The 6 th National Conference for Clinical Research 2012 (NCCR 2012) aims to serve as a platform that aims to bring together clinical investigators, industry professionals, regulatory agencies and policy makers in order to address the issues and challenges of the industry. By gathering people from various research disciplines, the event aims to foster constructive and forward looking discussions, sharing of experiences, and mutual commitment towards the betterment of humanity; September 23-25, 2012, Sunway Pyramid Convention Centre, Malaysia For details contact: Association of Clinical Registries, Malaysia (ACRM) Tel: +603 4044 3060 Fax: +603 4044 3080 Email: contact@acrm.org.my Website: www.nccrconference.com.my
CPhI Worldwide The event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain 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
The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals
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Modern Pharmaceuticals I May 2012
Book Review Gene Cloning and DNA Analysis: An Introduction Editor: TA Brown Price: ` 3850/Known worldwide as the standard introductory text to the important and exciting area of recombinant DNA technology, ‘Gene Cloning and DNA Analysis – An Introduction’ addresses new and growing areas of research while retaining the philosophy of the previous editions. Assuming the reader has little prior knowledge of the subject its importance, the principles of the techniques used and their applications are carefully laid out, with over 250 clearly presented illustrations. In addition to a number of informative changes to the text throughout the book, the final four chapters have been significantly updated and extended to reflect the striking advances made in recent years in the applications of gene cloning and DNA analysis in biotechnology: Extended chapter on agriculture including new material on glyphosateresistant plants New section on the uses of gene cloning and PCR in archaeology Coverage of ethical concerns relating to pharma, gene therapy and genetically modified crops This book remains an essential introductory text to a wide range of biological sciences students; including genetics and genomics, molecular biology, biochemistry, immunology and applied biology. It is also a perfect introductory text for any professional needing to learn the basics of the subject.
Molecular Cell Biology Editors: Harvey Lodish, Arnold Berk, Chris Kaiser, Monty Kreiger, Matther Scott, Anthony Bretscher, Hiddle Ploegh and Paul Matsudaira Price: ` 5000/‘Molecular Cell Biology’ stands out from its peers in this course in that it provides a clear introduction to the techniques and experiments of scientists past and present, not just an ‘encyclopaedia’ of information. This experimental emphasis, together with a solid paedagogical framework in the chapters, provides the clearest, most cutting-edge text available. The value of this incredibly extensive reference book lies in the attention it gives to explaining methods and techniques as fully as is possible in a text that addresses so many aspects of this fast-expanding field. This book is an essential tool for both students and professionals that need to broaden their knowledge in molecular cell biology. It provides the fundamental concepts and contains high quality illustrations/graphics. This is a very comprehensive book about molecular cell biology. It starts from the very basics of chemistry and protein, and ends with a clear molecular description of cell cycles and cancer. This book serves as a systematic guide to the professionals involved in the industry. Further, this book can also be considered as an aid to the researchers and the pharma students, both for their professional and academic purposes.
Reviewer: Sreya Sen MSc Biotechnology, St Xavier’s College, Kolkata
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Products Steam boiler The fully automatic package steam boiler (IBR) has capacity ranging from 100 kg/ hr to 2000 kg/hr with operating pressure of 10 kg/cm² g. Smoke tube & water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. The unit is equipped with high efficiency oil/gas burner with air pre-heater arrangement which gives high thermal efficiency. Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com
Rapid mixer granulator These are designed to meet the requirements of GMP. The contact parts are made of SS-304/316. These granulators come with specially designed control panel with display system and microprocessor. The bowl, lid mixing agitator and discharge housing are made of stainless steel. Al MS parts of the machine are cladded/covered
US Bottlers Machinery Company North Carolina – USA Tel: +1-704-5884750 Email: info@usbottlers.com Website: www.usbottlers.com
Freezer The MDF-C2156VAN freezers provide stable and highly uniform ultra-low temperatures for the longterm preservation of viable cells, tissues and biological materials. Offering significant advantages, these large capacity 150°C freezers combine exceptional performance and durability with reduced energy consumption and quiet operation. The freezers incorporate patented third-generation VIP PLUS insulation panels. Sanyo E&E Europe BV Etten-Leur – Netherlands Tel: +31-76-5433833 Email: sales.nl.seee@sanyo.com Website: www.eu.sanyo.com
Sieves
with stainless steel. Avon Pharma Machines Pvt Ltd Thane – Maharashtra Tel: 0250-2450638 Email: contact@avonpharmamachines.com
Bottle cappers Rotary chuck style bottle cappers are designed to apply and rotate a pre-sorted cap on a container, based on a predetermined applied torque. The containers are fed onto the rotary chuck style capper and are separated and positioned on individual capping stations. Caps are pre-sorted and fed on the sliding table of the machine.
These are silicon moulded sifter sieves, fluid bed dryer (FBD) sieves and FBE dryer sieves. The silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. These are available in rivetted and special non-rivetted design. The mesh sizes vary from 4 mesh to 500 mesh with ASTM & BSS Standards. Atlanto Enterprises Mumbai – Maharashtra Tel: 022-23096098 Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net
Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818
eg, MPH Laboratory software and send it to 51818
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Modern Pharmaceuticals I May 2012
Products Starch paste kettle These are specially designed for preparation of binder materials. The hemispherical kettles with jacket are mounted on trunion supports with the help of shaft. These kettles have a small cylindrical top shell with a spout for pouring out binder mass. The starch paste kettles are made of SS-304/ SS-316. These come with anchor type beater for paste mixing. Bombay Pharma Equipments Pvt Ltd Mumbai – Maharashtra Tel: 022-28594877 Mob: 09820124804 Email: bombaypharma@vsnl.net Website: www.bombaypharma.com
Linear vial washing machine These high-speed linear vial washing machines are totally fabricated from SS materials, including the basic frame. The machines are suitable for handling wash of 5 ml to 30 ml vials without changing parts. These are provided with high-pressure spray nozzles that enter into the vials during washing time. The linear vial washing machines are equipped with safety devices to ensure smooth and silent operation. Laxmi Industries Ahmedabad – Gujarat Tel: 079-22893810 Email: laxmiindustries_ad@yahoo.com
Coating pan These are totally enclosed with stainless steel cladding and are available with standard gearbox, motor and hot-air blowing arrangements. The coating pans are provided with interlocked electrical circuit so that the heaters can be operated only after the blowers are switched ON to avoid burning of the heaters. These coating pans are
May 2012 I Modern Pharmaceuticals
manufactured from the SS-304 AISI 2B prime material quality with adequate mouth opening and depth. Allegro Pharmachem Equipment Thane – Maharashtra Tel: 022-40146872 Email: allegro@allegroindia.com Website: www.allegroindia.com
Stoppering machine These servo rotary stoppering machines are crafted for cleanroom productions. The compact size allows for a sideby-side configuration, doubling the speed and matching the speed of the liquid filling machines for over 200 vials per minute side. These systems perform full and partial insertion and can be easily changed over to different stopper and bottle sizes. Automated Machine Technologies, Inc North Carolina – USA Tel: +1-919-3610121 Email: office@amtliquidfilling.com Website: www.amtliquidfilling.com
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Products Capsule filling machines Karishma Pharma Machines offers manually-operated capsule filling machines for smaller batches and R&D purpose. These capsule filling machines are simple to operate, having negligible rejections and weight variation. They can be supplied with interchangeable parts for all standard sizes. The capsule filling machines have recommended interchangeability for optimum output of 0/00-0/1/2—3/4/5. Output ranges from 55,000 to 60,000 capsules per 8-hour shift. Karishma Pharma Machines Mumbai - Maharashtra Tel: 022-2380 5979, Mob: 09821069064 Email: zabinmenon@vsnl.com Website: www.karishmapharma.com
Conductivity meters The mhoCounter CT-10 is a conductivity indicator & mhoCounter CT-11 is the meter with relay output option, which is programmable. Microprocessor-based electronics allow wide operating range and long term signal stability. Optional relays provide control for adjustment or alarms. Also the meters come with saddle mounting option or standard fittings to adopt to any process flow solution. Technical specifications are: function: conductivity/TDS indication & relay output; accuracy: ±2 per cent of FSD; meter dimensions: 111 mm x 106 mm x 68 mm; display: 4-digit customised LCD; mounting; online type vertical or horizontal; installation: solventable T or clamp-on saddle; protection: weatherproof enclosure; and programming: through front panel keys. Vatturkar Industrial Pune - Maharashtra Tel: 020-2538 0568, Email: response@vatsmeter.com Website: www.vatsmeter.com
In-line filling & stoppering machines Sterifill F200 inline filling and stoppering machines are provided for aseptic environments that can reach an output of up to 320 pieces per min. The machines are manufactured in AISI-304 or AISI-316 L and are fully compliant with cGMP standards. Also offered are high shear mixers that are designed to perform wet granulation processes, combining active products by adding a binder solution. The granulation process is carried out very quickly due to the high energy transmitted to the product by the turbulence caused by the combined action of impeller and
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chopper blades. The impellers are specially designed to reduce product sticking to the blades, and can be easily removed for cleaning. IMA - Industria Macchine Automatiche SpA Bologna - Italy Tel: +39-51-783111 Email: corporate.communications@ima.it
Freezers Sanyo MDF-C2156VAN freezers from provide stable and highly uniform ultra-low temperatures for the long-term preservation of viable cells, tissues and biological materials. These incorporate patented third-generation VIP PLUS insulation panels, reducing the wall thickness from 175 mm to 135 mm. This achieves up to 25 per cent more storage capacity compared with a conventionally insulated freezer without increasing the footprint. The resulting capacity of 231 litres accommodates up to 14,000 2 ml cryo-tubes. In addition to the Sanyo-developed insulation, a double lid gasket helps maintain internal temperature stability by preventing coldair loss. The freezers also provide uniform storage temperatures without the risks from sudden liquid nitrogen eruptions or splashing when samples are removed. Sanyo E&E Europe BV Etten-Leur - Netherlands Tel: +31-76-5433833 Email: sales.nl.seee@sanyo.com, Website: www.eu.sanyo.com
Pharmaceutical medicines Schwitz Biotech is engaged in offering a wide assortment of pharmaceutical medicines that are known for their effective results. Made in proper hygienic conditions, these medicines are categorised into topical, oro-dental, gynaec & haemostats, intravenous fluids, anti-allergic, cold & cough medicines, antibiotics & quinolones & cephalosporins, antacids, anti-ulcerants & laxatives and appetite stimulants enzymes. These are formulated under the supervision of experts for ensuring optimum quality and durability of medicines. Schwitz Biotech Ahmedabad - Gujarat Tel: 079-2749 3057, Mob: 09825374233 Email: schwitz_rkb@rediffmail.com Website: www.schwitzbiotech.com
Modern Pharmaceuticals I May 2012
Products Cleanroom moulds Adapplicator, Alu cap, Snap cap, PE bottle pack cap, PE twin port cap are only some of many cleanroom moulds from Braunform. Highly sensitive packaging and measuring components, caps for use in dental and insulin fields, dialysis components, hygiene products and the Adapplicator system developed by Braun, the spray alternative to needle injection, are few examples. Neejtech India Ahmedabad - Gujarat Tel: 079-26561312 Mob: 09825040231 Email: info@neejtech.com Website: www.neejtech.com
Disposable bioreactor These are single use systems made of medical grade plastics, which are presterilised and ready for use, therefore not needing cumbersome SIP and CIP. Agitated by means of an external gyrational motion, which uses gravity naturally to make the contents flow in a uniform circumferential direction in a specially shaped round bag. Lablinks Biotech Pvt Ltd Bengaluru - Karnataka Tel: 080-32440830 Mob: 09343748099 Email: ravindranath@lablinksbiotech.com Website: www.lablinksbiotech.com
Precision melt supermix The new precision melt supermix delivers robust high resolution melt performance for sensitive and accurate detection of single nucleotide polymorphisms and CpG methylation for epigenetic studies. The PCR reagent is compatible with all HRMcapable thermal cyclers. Traditional genotyping
May 2012 I Modern Pharmaceuticals
methods, such as denaturing high-pressure liquid chromatography and single-strand conformation polymorphism, involve lengthy protocols and require multiple days for completion. Bio-Rad Laboratories California – USA Tel: +1-800-2246723 Email: diagcs@bio-rad.com Website: www.bio-rad.com
Gravity feed metal detector These are designed to detect metal contamination in dry, powdery or granular free-flowing products that can be gravity fed through a pipe. The detectors feature high sensitivity, high throughput and is compact in size. Both the reject chute and frame are of stainless steel. The metal detectors are designed to minimise system space. Target Innovation Navi Mumbai - Maharashtra Tel: 022-27790077 Mob: 09823309636 Email: rajesh@targetinnovations.com Website: www.targetinnovations.com
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Products Rotary vane vacuum pump The Minivac SVL series of low vacuum pump is a sliding vanetype direct/belt-driven vacuum pump mounted on common base frames. It is compact in size, vibration-free and hence can also be mounted inside the machine. The pump attains maximum vacuum levels up to 29” of Hg with capacities ranging from 502000 lpm. Unique design of the lubrication system positively feeds minimum required oil to all rotating and frictional parts. The pump is useful in applications like capsule filling/capsule printing machines and other pharmaceutical machineries, packaging/ labeling machines, screen printing/plate making, book binding/ folding machines, vacuum chucking, etc. Shree Siddhivinayak Industries Dist Thane - Maharashtra Tel: 022-28458372 Email: minivac@rediffmail.com Website: www.minivacpumps.com
Filtration and separation products Advantec’s wide range of filtration solutions are used for laboratory, research and process applications. These products are used in a wide variety of scientific capacities and applications, such as microbiological analysis, air/ gas filtration, and environmental monitoring. Advantec’s range of filtration products fits comfortably within Cole-Parmer’s own product range. It offers customers an additional and valuable range of unique quality products that will enhance their processes and research. Cole-Parmer India Mumbai - Maharashtra Tel: 022-67162222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in
Diaphragm vacuum pump The chemical-resistant diaphragm vacuum pump has oil-free vacuum option for laboratory and pilot scaled application. Typical applications include evacuating chemically aggressive gases and vapours from such equipment as rotary evaporators, vacuum drying
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cabinets and centrifugal concentrators. The diaphragm vacuum pump is available in various options of materials, like EPDM, neoprene, Viton and Teflon coated neoprene rubber. It is also available in the range of 15-33 lpm and generates a maximum vacuum of 30 Torr. Chemical resistant vacuum pump is supplied with three-phase flameproof motors. Sri Vishnu Pumps Manufacturing Co Mumbai - Maharashtra Tel: 022-28458373 Email: vishnupump@rediffmail.com Website: www.minivacpumps.com
Walkable ceiling system Iclean ceiling system is designed to fit every requirement and adhere to stringent quality standards that fit in seamlessly with the rest of the room paneling. The ceiling panels are fastened to profile that are placed on a particle-tight extruded aluminium grid matrix with caulked silicone sealant. Materials of construction include GI powdercoated & SS-304, 40 mm thick ceiling panels, 0.8 mm thick skin pass powder-coated GI sheets, factory-made cutouts, fireretardant PUF as in-fill, etc. Integrated Cleanroom Technologies Ltd Hyderabad - Andhra Pradesh Tel: 040-3213478, Mob: 09989212162 Email: srinivas@cleantech.com Website: www.icleantech.com
Vial and bottle cap sealing machine This machine is compact, versatile and elegantly finished machine for sealing vials and bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium/ plastic caps. Some of the features include uniform sealing, no manual involvement, no repeated setting, while the sealing rollers rotate on bearings to give smooth motion for uniform sealing. Minimum time is required to change over from one size of vial to another. It also does not require any lubrication. Anju Pharmaceuticals Indore - Madhya Pradesh Tel: 0731-2523968, Mob: 09893562415 Email: anjupharma@hotmail.com Website: www.anjupharma.com
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Products Shaking incubator The compact benchtop Stuart SI500 and SI505 shaking incubators have a unique retractable platform providing easy access to samples, a digital display showing the independently controlled temperature and speed, and USB connectivity for long-term monitoring of the incubator temperature via a PC. Removable water reservoirs increase the humidity in the chamber of the Stuart SI505, dramatically reducing sample evaporation. The Stuart SI500 incorporates a versatile clamping system for securing flasks of most sizes, while angle-adjustable stainless steel accessory tube racks with magnetic locking system providing quick coupling and de-coupling. Bibby Scientific Ltd Staffordshire - UK Tel: +44-1785-812121 Email: info@bibby-scientific.com Website: www.bibby-scientific.com
Vial inspection machine In the vial inspection machine (model SMPLAIM-72) all contact parts are made of stainless steel and approved engineering plastics. Magnified view with back lighting is available and rotation of spinners can be adjusted to give desired vortex in liquid. The vial inspection machine has separate counters for placing good and rejected products.
Walk-in humidity chamber
The work bench features steel frames, panels and shutters made from prime quality CRCA steel. This steel is coated with epoxy paint and a special encapsulated powder that has a film thickness of 40-60 microns. This imparts a high scratch-resistance and the encapsulated powder ensures that no oil or chemical marks are formed on the surface. Every shelf on the cabinet is equipped with a load carrying capacity of 40 kg UDL to ensure maximum efficiency in the cabinet drawer. Highprecision double-extension ball slides are used.
The unit has double-walled insulated PUF modular panels, which can be easily assembled at site. Interior is made of stainless steel and exterior is either made of mild steel finished with powder coating or stainless steel. The unit has full-length inner glass door and outside metal door with magnetic gasket and lock. It is provided with perforated stainless steel trays and has forced air circulation for uniform temperature. The intelligent controlling system has PLC base and PC communication. It has long lasting stainless steel tubular heaters with SS fins.
Godrej & Boyce Mfg Co Ltd Mumbai - Maharashtra Tel: 022-67964363, Mob: 09920113138 Email: arunp@godrej.com Website: www.godrej.com
Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in
Snowbell Machines Pvt Ltd Thane - Maharashtra Tel: 0250-6456141, Mob: 09322777625 Email: marketing@snowbellmachines.com Website: www.snowbellmachines.com
Work bench
May 2012 I Modern Pharmaceuticals
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Products Metal analyser The 7700 series ICP-MS metal analyser is productive, simple-touse, high sensitivity, low background, better interference removal, increased flexibility, easier to maintain and service. This workhorse 7700x is used for most applications, and in high-throughput commercial labs. It is designed specifically for semiconductor applications. The new 7700e offers a simplified and easy-to-use system for routine analysis. Featuring a new, configurable MassHunter software platform and a host of hardware developments, including a new frequency-matching RF generator and 3rd generation Octopole Reaction System (ORS3), all three 7700 series mainframes provide unrivalled levels of performance and ease-of-use. Agilent Technologies India Pvt Ltd New Delhi Tel: 011-51496664 Email: agilent@agilent.com Website: www.agilent.co.in
Screening machine The tumbler and vibration screening machines are available as per GMP and FDA-regulations for applications in pharmacy, food and fine chemicals. This machine is are used for treatment of valuable powders, pellets and granules. The hygienic design includes solutions for WIP-cleaning devices and ATEX certification. The tumbler screening machine is a high-performance screening machines for fractionating, protective screening and dedusting. The threedimensional tumbling movement creates exceptional fine cuts for the bulk solids. Modular design allows the production of additional fractions through additional screening desks in one machine. For simple applications vibration screening machines, type VTS or Vibrall, are economic alternatives.
be filled with a weight variation within 2 per cent. Variable AC frequency drive for main motor ensures speed adjustment. The faulty capsule and filled capsule ejection stations are equipped with individual air controls. This machine is simple to operate and easy to maintain. The special purpose gauges ensures quick and easy changeover. Karishma Pharma Machines Mumbai - Maharashtra Tel: 022-24181490, Mob: 09821069064 Email: capsulefiller@karishmapharmamachines.com Website: www.capsulefiller.net
Mini bilayer press The mini bilayer press is designed to represent two-layer tablet productions at a small scale. With its larger turret diameter, variable speed allows for realistic scale up to larger rotary presses. It is provided with two force feeder system, which helps in maintaining uniform die fill and represents production equipment. It is provided with pressure compensation hydraulic system. Tablet thickness and weight adjustment settings are outside the machine. It is designed as per cGMP norms. All parts in the compression zone are of SS-304 or electroless nickel-plated. Aayush Techno Pvt Ltd Ahmedabad - Gujarat Tel: 079-25898901 Email: contact@aayushtechno.com Website: www.aayushtechno.com
Liquid ďŹ lling machine
Automatic capsule ďŹ ller
The four-head liquid filling machine is a highly versatile machine for filling foamy as well as other liquids into containers. It has a unique bottle separation method in which no turret or holding slides are used. This machine fills the liquid using the syringe principle and is very easy to use. Turntable is provided for bottle filling. This liquid filling machine is provided with variable speed conveyor and is suitable for filling all types of liquids with less density. It is equipped with 1.5 HP motor with gear box and the diving nozzles is used for prevention of spillage and for foamy liquids.
The model-A25 high-speed automatic capsule filling machine is compact, sturdy, covered with stainless steel panels, and the hood is covered with acrylic guard. It is provided with tamping mechanism for powder filling, which enables capsules to
Harshika Industries Dist Thane - Maharashtra Tel: 0250-3246533, Mob: 09869457909 Email: harshad.g@rediff.com Website: www.filling-machinemanufacturer.com
Allgaier Werke GmbH Uhingen - Germany Tel: +49-7161-301353 Email: siebtechnik@allgaier.de Website: www.allgaier.de
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Products Aluminum blister foils The company manufactures different kinds of aluminum blister foils that are widely used in various industries. Aluminum blister foils are suitable for high-speed packing applications. These foils are one side coated with heat lacquer and the other side unprinted or printed to facilitate pharmaceutical blister packaging. The range of aluminum blister foils are resistant to moisture, vapour and gases. These are available in compact sizes and are economical as compared to strip packs. The foils help in the easy removal of the tablets as hard foils break easily when pressed hard. Also offered is a range of foils as per specific requirements of customers. Krish Pharmapack Dist Thane - Maharashtra Tel: 0250-3249666, Mob: 09594000600 Email: krishpharmapack@gmail.com Website: www.krishpharmapack.com
Digital ow meters Vatturkar Industrial offers digital flow meters and digital conductivity meters. Operators can easily install and recalibrate the meters online. The flow meters are proven in harsh industrial environment and are service free units based on the state-of-the-art advance microprocessor technology. Both fieldmounted as well as panel-mounted meters are available. The digital flow meters come in different forms, ie, standard panel-mounted and field-mountable type (specially designed IP-65 enclosure to suit open atmosphere industrial conditions). These are based on paddle wheel insertion type sensor. These are applicable in water treatment industry, pharmaceutical industry, beverage/distillery industry, bottling industry, oil/refining industry, ready mix concrete plants, automatic liquid dispensers, chemical industry, etc. MTS Engineers Pvt Ltd Ahmedabad - Gujarat Tel: 079-2640 0063, Mob: 09879407970 Email: sanjay.prajapati@mtsengrs.com, Website: www.mtsengrs.coj
Pharmaceutical label seals These seals are perfect for pharmaceutical labelling and security label seals type-D. These are provided with covert security mark and a warning message to be applied on individual carton reaches retail outlets. These are designed to break into small pieces during any attempt to remove
May 2012 I Modern Pharmaceuticals
it from the applied surface and prevent subsequent re-application. Evidence of tamper is obvious. The pharmaceutical label seals are provided with invisible hidden mark for authentication. These can be used for a multitude of identification purpose and as tamper evident seals in pharmaceutical, bulk drugs, chemicals, agrochemicals, etc. Safcon Security Seal Kolkata - West Bengal Tel: 033-2226 0513 Email: safcon@vsnl.com, Website: www.safconsecurityseal.com
Electric blankets Aristocrat electric blankets offered are waterproof, shockproof, autocut, soft underlay to provide constant slow motherly warmth. It is a relief for the patients of asthma, gout-arthritis, backaches, bodyaches & pains, patients of diabetes, low blood pressure, and the aged alike. These blankets supplement the much needed body energy and as such are really useful for senior citizens, some of whom pop out during sleep in extreme winters for need of energy. The electric blankets can be used in hotels to reduce high electricity bills; and can also be used in hospitals to provide comfort to patients. Medico Pharmaceuticals Processors Amritsar - Punjab Tel: 0183-2258586, Mob: 09356000059 Email: info@medico.co.in Website: www.medico.co.in
Hydrogen gas generator Series WM-H2 hydrogen gas generator use the latest polymer electrolyte membrane (PEM) technology to produce pure hydrogen. The exclusive double gas column dryer regeneration system eliminates all downtime for maintenance. Standard features are models available in 120, 180, 260, 400, 500, 650, 800, 900, 1000, 1200 cc/min, purity is > 99.99999 per cent, has automatic dryer regeneration, offers pressure up to 12 bar (16 bar on request), etc. The instrument has patented gas/water separator electronically controlled. It provides LCD touchscreen, real-time outlet pressure, water quality, water level, auto-diagnostics with alarms. Remote PC monitoring is standard via RS232 or RS485 to interface the unit with customer’s PC software. Lab Intelligence Appliances Ahmedabad - Gujarat Tel: 079-26561557, Mob: 09377729989 Email: kamal@lia.net.in Website: www.lia.net.in
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Products Gas detector tubes UniPhos gas detector tubes offered my United Phosphorous are easy, quick and accurate method for direct, onsite measurement of gases, vapours and aerosols. These tubes are simple to use, requiring minimum maintenance and no calibration. The gas detector tubes are available for NH3, H2S, SO2, CL2, PH3, HCI, HCN, CO, CO2, O2, C6H6 and many other gases and vapours. These are also available with spot check of toxic gas concentration at work place at specified intervals. The gas detector tubes are calibrated for a fixed volume of air sample, which is drawn using a sample draw pump. The scale on the glass tube reacts to the stain length of PPM of contaminant concentration. This method of measurement is simple, accurate and highly specific. United Phosphorous Ltd Dist Valsad - Gujarat Tel: 0260-2730156 Email: gasdetection@uniphos.com Website: www.chemo-electronic.com
Temperature data loggers Ambetronics offers temperature loggers that are suitable for pharmaceutical industries. These data loggers have measuring range of -35ºC to 80ºC, accuracy ±0.5ºC and resolution of 0.1ºC with sensor Pt1000. The measuring rate can be selected from 1 minute to 8 hours. The data loggers can store 4,000 values data in memory. Measuring mode has automatic with loop, start/stop or start with set measuring rate. Battery life is 3 to 5 years. The data logger housing is made up of stainless steel, PEEK. They have IP68 protection class/housing for pharmaceutical industries.
no bottle friction and no particles are formed. Each pump consists of only two parts, for perfect sterilisation in an autoclave. These machines have a capacity of 400 bottles/min, filling volumes of up to 30 ml and bottle diameter of up to 36 mm. Marchesini Group Bologna - Italy Tel: +51-651-8711 Email: sales@marchesini.com
Autoclavable stirred tanks Autoclavable stirred tanks and pressure vessels, are a novel concept of in biotech and pharma manufacturing. A final formulationcum-blending tank is usually employed during filling of sterile liquid formulations. The tanks are sterilised in an empty condition inside an autoclave large enough to hold the tank. These can be autoclaved in vertical and horizontal orientation, without causing damage to the agitators. After autoclaving, the motor is fit and the product is aseptically transferred into the tank under stirring. These are available in a variety of sizes, vessels can be autoclaved in horizontal position; maximum operating temperatures up to 130°C & pressure up to 2.5 bar(g); all nozzles are provided with sanitary TC ends; and manufactured from good quality stainless steel. Navin Process Systems Pune - Maharashtra Tel: 020-2546 0214, Mob: 09273107155 Email: info@napro.co.in Website: www.napro.co.in
Tablet compression machine Ambetronics Mumbai - Maharashtra Tel: 022-2837 1086, Fax: 022-2822 6570 Email: info@ambetronics.com Website: www.ambetronics.com
Filling & capping machines Steril 400 filling and capping machines are offered for sterile applications in the pharmaceutical industry. These can be installed under an isolator. These consist of three modules and are suitable for different layout requirements. The machines are completely accessible from the front and are protected by laminar flow recycling. Special care is taken to prevent obstacles to the linearity of the sterile air flow so that negative eddies would not form. Due to the bottle conveyor system, which uses a SS-316L belt, there is
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The tablet compression machine (tablet press) is used to make tablets according to a pre-determined design. Punches and dies set into the tablet press to actually shape the tablets. The machine makes tablets for a variety of industries; but its largest application is in pharmaceuticals and vitamins. It is provided with turret made of special grade SG iron casting and interlock switches to all guard for safety of operator. Features include paint-free compression zone, variable speed step pulley, dust extraction nozzles, antivibration mounting, etc. Shiv Pharma Engineers Ahmedabad - Gujarat Tel: 079-29092380, Mob: 09377535927 Email: sales@shivpharma.com Website: www.gmpmachines.com
Modern Pharmaceuticals I May 2012
Products Fluid bed dryer This dryer is used for drying of wet material. It is equipped with air handling unit. The inlet air filtration is through pre, micro vee and hepa filter. It performs uniform and harmonious drying operation in a specified time. It has applications in tablet-granulation section of pharma industries. This dryer is compliant with cGMP under WHO and USFDA. Also offered is diversified novel advanced techno-upgraded qualitative model of fluid bed dryer like PLC operated, semiautomated and manually operated dryer with multi faceted and user-friendly features. Ratnakar Pharma Machinery Ahmedabad - Gujarat Tel: 079-22892614, Mob: 094270 31284 Email: ratnapd@yahoo.co.in Website: www.ratnakarpharmamachinery.com
FRP storage tank The FRP storage tank is manufactured by hand lay-up and/ or by filament winding process for the storage of highly corrosive chemicals, acids and wastes. It is available in capacity up to 250 kl in various shapes, like square, round, rectangular vertical and horizontal with flat bottom or conical bottom. The key feature of this tank is that it offers resistance to chemical and weather. It is lightweight, easy-to-maintain featuring good physical and mechanical strength. The reaction vessel is available with suitable lined agitator, gear box and electric motor. EPP Composites Pvt Ltd Rajkot - Gujarat Tel: 02827-287059 Email: marketing@epp.co.in Website: www.atikagroup.com
vapour-tight construction with nitrogen blanketing for hazardous chemicals. CIP design with built-in cleaning nozzles ensures no product cross-contamination. The centrifuge is offered in threepoint pendulum suspension and four-point inertia plate mounted designs to suit application considerations. United Engineering Enterprises Mumbai - Maharashtra Tel: 022-23083990, Mob: 09820761808 Email: uenggent@gmail.com Website: www.united-centrifuges.com
Sanitary tubes fittings A wide range of stainless steel sanitary tube fittings for pharma, food, beverages, breweries, cosmetics and allied industries are offered. The range includes bends, Tees, reducers, pipe, support and sight glass, etc. These are available in tube OD sizes ranging from ½” to 6”. End connections available are tri-clamp, DIN and SMS. These fittings are manufactures from SS-304, 316 and 316L, duly electro polished. All these products confirms to cGMP and FDA standards. Elastomers offered are of food grade and can be offered in EPDM, neoprene, silicon and viton. Cris Engineering Works Mumbai - Maharashtra Tel: 022-2685 9440, Mob: 09892273314 Email: roque_ferns@rediffmail.com Website: www.criseng.com
Pallets These pallets are offered as per GMP & USFDA norms and are used for multifarious applications in different industries. Designed for optimal load bearing capacities, the pallets are manufactured on state-of-the-art plants. The pallets have many outstanding features and can also be tailor-made to meet customers’ special requirements.
Bottom discharge centrifuge This centrifuge is fitted with a cake scrapping arrangement, which can be motorised or hydraulically operated to enable to scrape the stickiest of cakes. The cake is discharged through the bottom chute provided. This results in reducing manual labour, less cake handling loss and uniform cake washing. The centrifuge is offered in
May 2012 I Modern Pharmaceuticals
Sintex Industries Ltd Kalol - Gujarat Tel: 02764-253500 Email: icontainers@sintex.co.in Website: www.sintex-plastics.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 83
List of P Products
Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818
eg, MPH Laboratory software and send it to 51818 Product
Pg No
Product
Pg No
Product
Pg No
Acoustic enclosure ...........................................28
Fluid bed dryer.......................................................83
Pure steam generator ...........................................BC
Agitator.....................................................................3
Freezer...............................................................73, 75
Rapid endotoxin detection system ....................75
Aluminum blister foils ...........................................81
FRP storage tank ...................................................83
Rapid mixer granulator ..........................................73
Analytical instrumentation ....................................47
Gas detector .....................................................65
Refrigrated compressed air dryer...........................27
Analytical instruments ...........................................86
Gas detector tubes..................................................82
Roots blower...........................................................28
AODD pump..................................................... BIC
Gravity feed metal detector ...................................75
Rotary evaporator .....................................................3
Autoclavable stirred tanks ......................................82
Heat exchanger ................................................. 8
Rotary pump ..........................................................38
Autoclaves .............................................................BC
Heating baths ...........................................................3
Rotary tablet press..................................................38
Automatic capsule filler .........................................80
High pressure homogeniser .....................................3
Rotary vane vacuum pump ....................................76
Batch disperser.................................................. 3
Hot plates .................................................................3
Sanitary tubes fittings.......................................83
Blow/Fill/Seal machines .................................. 4, FC
HPLC...............................................................47, 86
Screening machine .................................................80
Bottle cappers .........................................................73
Hydrogen gas generator .........................................81
Seamless pipes ........................................................73
Bottom discharge centrifuge..................................83
Informatics ......................................................47
Shaker .......................................................................3
Bulk bag filler .........................................................79
Inline disperser .........................................................3
Shaking incubator ..................................................79
Calorimeters ..................................................... 3
In-line filling & stoppering machines...................75
Sieves.......................................................................73
Capsule filling machines ................................75, BC
Inspection system ...................................................13
Cartoners ..............................................................BC
Kneading machine ............................................ 3
Chromatography ....................................................86
Laboratory reactor............................................. 3
Cleanroom moulds .................................................75
Laboratory software .................................................3
Coating pan ............................................................73
Linear vial washing machine .................................73
COD anaylser.........................................................65
Liquid filling machine............................................80
Coloumns & chemistries .......................................47
Liquid sterile filling machine...............................BC
Colour masterbatches.............................................43
Lonizer....................................................................27
Columns .................................................................86
Magnetic stirrer ................................................ 3
Compact pneumatic cylinder.................................27
Mass spectroscopy ..................................................86
Conductivity meters ...............................................75
Metal analyser ........................................................80
Corrugated tube heat exchanger .............................8
Mills ..........................................................................3
Diaphragm vacuum pump................................76
Mini bilayer press ...................................................80
Digital flow meters.................................................81
Molecular spectroscopy ..........................................86
Disc pump .......................................................... BIC
Overhead stirrer ................................................ 3
Disperser ...................................................................3
Pallets ..............................................................83
Disposable bioreactor .............................................75
Pharmaceutical label seals ......................................81
Vacuum conveyor ...................................................79
Dry van pump ........................................................28
Pharmaceutical medicines ......................................75
Vacuum system .......................................................28
Electric actuator & gripper ..............................27
Pilot plant .................................................................3
Vial and bottle cap sealing machine .....................76
Electric blankets .....................................................81
Plastic masterbatches .............................................45
Vial inspection machine.........................................79
Elemental analysis ..................................................86
Plate heat exchanger ................................................8
Walkable ceiling system ...................................76
Empower ................................................................47
Pneumatic cylinder .................................................27
Walk-in humidity chamber ...................................79
Filling & capping machines .............................82
Precision melt supermix .........................................75
Welded pipes ..........................................................73
Filtration and separation products.........................76
Pump............................................................. BIC, 28
Work bench ............................................................79
Solid-liquid mixer ....................................................3 Stainless steel pipe..................................................73 Starch paste kettle ..................................................73 Steam boiler............................................................73 Stoppering machine ...............................................73 Tablet compression machine ............................82 Tablet press machine..............................................38 Tefzel HHS Isotactic PP material ..........................6 Temperature data loggers.......................................82 Thermoplastic valves & piping system ...................6 Thermostat & vaccum dryer / mixer.......................3 TPU masterbatches................................................43 Tubes.......................................................................73 UHPLC ...........................................................86 UPLC .....................................................................47 U-tubes ...................................................................73 Vacuum booster pump......................................28
BC-Back cover, BIC-Back inside cover, FIC-Front inside cover
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List of Advertisers Advertiser’s Name & Contact Details
Alok Masterbatches Ltd
Pg No
43
T: +91-011-41612244
Hapman India
E: aquaas@satyam.net.in
T: +91-020-66047894
W: www.aquaservicesindia.com
E: info@hrsasia.co.in BC
SME Mentor
73
T: +91-79-27540720
8
E: suraj@surajgroup.com W: www.surajgroup.com Thermo Fisher Scientific Sid Division
W: www.hrsasia.co.in Ika India Private Limited
E: suhas.rai@in.bosch.com
3 E: pradeep.kumar@thermofisher.com
T: +91-80-26253900
W: www.boschindia.com/pa 38
W: www.thermofisher.com
E: process@ika.in
Uniphos Envirotronic Pvt Ltd
W: www.ika.in
T: +91-79-25841491
Nichrome
W: www.cadmach.com
T: +91-020-66011001
E: singhrv@unipos.com
E: marketing@nichrome.com
W: www.uniphos-she.com
W: www.nichrome.com
UNP Polyvalves India Pvt Ltd
75
T: +91-80-25588175
33
E: india.customercare@crl.com Reynders Label Printing India Pvt Ltd
W: www.criver.com BIC
T: +91 149 3305400
T: +91-044-26271020
E: india@reynders.com
E: sales.psgindia@psgdover.com
W: www.reynders.com Salesworth India Pvt Ltd (Rommelag) 61
E: mktg@polyvalve.com W: www.polyvalve.com
FIC T: +91-80-28371900
T: +91-80-25274495
E: mail@salesworth.com
E: engexpo@infomedia18.in
W: www.waters.com
W: www.rommelag.com
W: www.engg-expo.com 28
Salesworth India Pvt Ltd (Seidenader)
13
Weiler Engineering Inc
T: +91-80-25274495
E: info@everestblowers.com
E: mail@salesworth.com
E: creed@weilerengineering.com
W: www.seidenader.de
W: www.weilerengineering.com
BC-Back cover, BIC-Back inside cover, FIC-Front inside cover May 2012 I Modern Pharmaceuticals
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T: +91-847-531-6733
T: +91-11-45457777
W: www.everestblowers.com
47
E: waters_india@waters.com
T: +91-09819552270
Everest Transmission
6
T: +91-265-2649248
Waters (India) Private Limited
W: www.psgdover.com Eng Expo
27
65
T: +91-22-6123500
E: info@cadmach.com
Dover India (P) Limited
86
T: +91-22-67429494
T: +91-9820421660
Charles River
Pg No
51
Suraj Limited
57 HRS Process Systems Ltd
Advertiser’s Name & Contact Details
W: www.moneycontrol.com/smementor
W: www.hapman.in
T: +91-265-2331748
Cadmach Machinery Co Pvt Ltd
79
E: info@hapman.in
W: www.alokmasterbatches.com
Bosch Limited
Pg No
T: +91-265-2517505
E: sales@alokindustries.com
Aqua Services
Advertiser’s Name & Contact Details
Our consistent advertisers
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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
May 2012
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