Modern Pharma - 16-30 September 2012 by Infomedia18

16-30 Sept ember 2012 I Vol 1 I N o 6 I `100

In Conversation With 13 Scan this code on your smart phone to visit www.mphonline.in

Dr Rajesh Jain Joint MD, Panacea Biotec Ltd

Cipla wins patent case against Roche

THE Delhi High Court recently held that Indian pharma major Cipla has not infringed upon the patent right of Swiss drug company F Hoffman La-Roche on a cancer drug. According to Justice Manmohan Singh, erlotinib hydrochloride, Roche’s patented drug, promoted under the brand Tarceva is also valid like Cipla’s cancer drug promoted under the trade name Erlocip. The decision came on a petition filed by Roche accusing Cipla of manufacturing and marketing the cancer drug under the trade name Erlocip, which it claimed was the generic version of its patented drug erlotinib hydrochloride, promoted under the brand Tarceva.

Plethico mandates Elara Capital for debt restructuring

PLETHICO Pharmaceuticals has mandated Elara Capital for restructuring its $ 75 million outstanding convertible bonds due in October. In October 16, 2007, the company had raised $ 75 million by issue of Foreign Currency Convertible Bond (FCCBs), which are due for maturity in October this year.

Notices to pharma companies for non-payment of Service Tax: Government

THE Government of India has recently served show cause notices to manufacturers of pharma products who have failed to pay Service Tax worth crore of rupees. According to the information provided by the Finance Ministry, necessary action to safeguard the government revenue has been taken as per the provision of Finance Act and Service Tax Rule. According to Srikant Kumar Jena, Minister of State for Chemicals and Fertilisers, more focus is required to be given towards collection of intelligence, intensive audits and anti-evasion checks to prevent evasion of tax.

Sun Pharma in Forbes most innovative list

RANKED among five other Indian companies, Sun Pharma has made it to the list of 100 most innovative firms in the world prepared by Forbes, US business magazine. Sun Pharmaceutical Industries, speciality pharma company, is ranked 38. In order to be considered in the list, at least 7 years of financial data for a given firm is needed. According to Forbes, firms with market value greater than $ 10 billion and those which make some investment in R&D were considered.

Special Focus 15

Strategy 18

Interface 19

Cosmeceutical trials in India Scanning the growth opportunities

‘Catching’ young doctors Hit hard, hit early!

James C Greenwood President & CEO, Biotechnology Industry Organization

Cathay Pacific starts biweekly Pharma LIFT services INDIA has about 74 US FDA-approved sites for pharma manufacturing, which is the highest outside the US. With pharma industry growing at more than 10 per cent per year, and having secured the position of being the third largest in the world in terms of volume, Cathay Pacific Airways have developed a reputation as a qualified pharma carrier with its brand ‘Pharma LIFT.’ Ashish Kapur, Regional Cargo Manager – South Asia, Middle East and Africa, Cathay Pacific Airways, said, “We are recognised as one of the most qualified pharma traffic carriers by many pharmaceutical companies and international freight forwarders who also have a solid healthcare traffic programme. Pharma LIFT is definitely a brand well established within the pharmaceutical industries.” Pharma LIFT is designed as per the requirements. Further elaborating on the services rendered, Kapur added, “Cathay Pacific product is tailor made as per shipper’s requirement, besides our wide global network we specialise in active pharma, heat and cooling pharma, passive pharma and room temperature pharma. Our thrust is to embrace pharma lift

Kapur

culture. Our staff takes care of every shipment; the salient features include automatic communication system, on-line temperature tracking, priority handling, 24/7 support and multiple critical control points. Overall, we offer comprehensive quality assurance with information transparency.” Currently, Cathay Pacific is working with GSK, Pfizer, Sanofi Pasteur. The services offered by them include on-line temperature track for active solution shipment, which allows companies to

access the shipment temperature at their finger tips. Kapur elaborated, “We also assure the alert system tricker preventive measure when temperature reading is at a risk level. We are giving customer a peace of mind using CX Pharma LIFT. We have over 60 stations qualified for Pharma LIFT operation. Once shipper qualifies CX, it means they can entrust CX to all Pharma LIFT routes as it is all under one service standard as design and monitor by CX headquarter.” The services are rendered to packages of all sizes using time and temperature packaging ranging from small to many units of containers and airlines pallet. Kapur said, “We have one charter 747 freighter carrying about 80T of pharmaceuticals on one freighter.” This year Cathay Pacific has already extended its services to Hyderabad with a biweekly freighter. Talking about the expansion plans, Kapur said, “We believe in the potential of India and are in the process of conducting an extensive research on the different destinations in India. We also continuously roll out Pharma LIFT to other CX and KA network as demand of service requires.”

Panacea in pact with Osmotica PANACEA Biotec Ltd, has inked a ten-year agreement with Osmotica Pharmaceutical, a major US-based global supplier of speciality pharmaceuticals to develop high barrier entry generic and branded pharmaceuticals. The new strategic alliance is based on a 50:50 profit, finance and risk sharing for a drug portfolio of 18 products across a wide array of therapeutic categories. Subsequent to the deal, Panacea will be responsible for R&D, product identification and manufacturing of the new compounds, while Osmotica will handle the USFDA approval, marketing and distribution of these generics in the US and

other global marketplaces. High barrier entry generics are difficult to develop with conventional technologies and are specifically used for a regulated delivery of drugs in patients.

Dr Jain

In addition, Panacea will also obtain fixed research emoluments apart from 50 per cent of the development expenses for each new added

product. Financial details of the agreement were not disclosed. Both companies will form a ‘Joint Steering Committee’ to monitor the entire development and commercialisation process. The new drug portfolio would be based on the Depo Injections and formulations based on nanoparticles. With the new range of products, both companies are expecting to tap the opportunity of $ 25 billion market in the US alone; with first product launch projected to hit the market by 2015. The alliance is forecast to strengthen the competitive positions of Panacea and Osmotica in the generic drug segment throughout the US and other key markets. - Nikunj Sharma

- Shibani Shah

Ramprasad Reddy to head Aurobindo’s US arm DRUG firm Aurobindo Pharma recently said that its Board has approved the appointment of P V Ramprasad Reddy as Executive Chairman of Aurobindo Pharma USA, Inc. According to the filing made by Aurobindo Pharma to BSE, the Board of Directors of the Reddy company has approved the proposal of appointment of Reddy as Executive Chairman of Aurobindo Pharma USA, Inc. Further, it also added that the said proposal is subjected to further approval of the shareholders of the company.

M o d e r n Pharma•16-30 Sept ember 2012

CONTENTS In Conversation With

Dr Rajesh Jain Joint MD, Panacea Biotec Ltd

Special Focus Cosmeceuticals Cosmeceutical quality Meeting demands vigilantly Cosmeceutical trials in India Scanning the growth opportunities

Interface

14 15 16

Siddhartha Sengupta Head - Pigments, Performance and Life Sciences Chemicals, Merck India

Insight & Outlook Policies & Regulations FDI in pharma: Understanding the criticality Strategy ‘Catching’ young doctors: Hit hard, hit early! Dr Rajan T D, Pharma Consultant & Practising Dermatologist

Interface James C Greenwood President & CEO, Biotechnology Industry Organization (BIO) The Indian Ayurveda market Landscaping OTC opportunities SreedeviYallamrazu, Senior Strategic Analyst, CubeX

17 18

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl

19 20

PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Shibani Shah, Avinash Pandey Nikunj Sharma (Delhi), Jasleen Kaur Batra (Bengaluru) ASSISTANT ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan

Event Preview Pharma Supply Chain Forum Assessing the pharma supply chain scorecard

REGULAR SECTIONS 5 Editorial / Guest Editorial 6 News, Views & Analysis 22 Tenders / Project 24 Event List 25 Book Review 26 Products 29 Marketplace 30 List of Products & Advertisers

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Modern Pharma•16-30 Sept ember 2012

Editorial

Intensified investment…Accelerated action

Editorial Advisory Board Ajit Singh

Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah

Chairman, IGPA & Secretary General, IPA

Daara Patel

Secretary General, IDMA

or the Indian economy, this would be the right time to move away from the slumber of the recent months, which has been holding back investments into the country and has resulted in a drag effect on several sectors. In this context, it seems the recent reshuffle in certain central ministries is bearing fruit, atleast in terms of FDI for the pharmaceutical sector getting green signal! Scanning the background details, one can observe that after a bevy of buyouts in the pharmaceutical sector and to address the health ministry’s concerns, a ministerial panel last year modified the pre-existing policy of automatic clearances and put foreign investment in existing pharmaceutical companies on approval route. Subsequently, many proposals for the pharmaceutical sector have reportedly been deferred by the Foreign Investment Promotion Board (FIPB), primarily due to lack of clarity in the government policy, which unfortunately sent farfrom-positive signals to the global investing community. However, as things stand today, the situation seems to be improving, albeit at its own pace. As reported recently, the government is actively considering to clear FDI proposals worth ` 3,000 crore by several pharmaceutical companies. Further, it is said that the Department of Industrial Policy

Guest Editorial

and Promotion (DIPP), which is the nodal body for FDI policy, is likely to issue clarifications soon, and thereby facilitate clearance of these proposals. It is important to note here that in cases where the control of an Indian pharmaceutical company changes hand to a foreign one, the FIPB nod should be required and other conditions be applied to the investment, as recommended by an inter-ministerial group formed by the Finance Ministry. Among others, one condition in such a case mandates the foreign investor(s) to ensure continuation in production of the essential drugs by the Indian company and there should be no curtailment in its R&D spend. Given the current gloomy global scenario, this as a whole is a welcome measure by the government since it not only sends clear and positive signals to the global investing community, but also boosts the business sentiment across the country. Concurrently, what is required is to be proactive and address other ‘procedural’ challenges linked to this strategic need in a timebound manner before the investment gets actually converted into operations.

Manas R Bastia manas@network18publishing.com

Growth stimulators for the pharma sector

he cost and development time of R&D has increased phenomenally has resulted in decreased numbers of New Chemical Entities (NCE) and has indirectly saturated the market for generics globally. In this scenario, there is a strong requirement of innovation-based products, which has resulted in the growth of speciality companies (who does innovative product development) in western world; however, similar proceedings in developing world are almost nil. The advantage of innovative product development is that it does not require huge resources and time like NCE development. It is designed on the already existing NCEs. In other words it is ‘adopting lower risk strategies and exploiting the potential of existing molecules with optimised drug delivery to get market share and exclusivity.’ The deliverables will be new products, new dosage forms, critical generics, etc for global market (US, EU, AUS/NZ, ROW, India, etc). Such products are required globally, and more than $100 billion market exists for that. The large Indian pharma companies are eyeing biosimilars as growth impetus, even as the

regulatory guidelines are still under preparation for biosimilars. In spite of the fact that the pharma sector has no recession there is always a fear among the Indian pharma sector as to whether it has reached its peak on growth and/or it is on the downward slide. The industry is facing unsurmountable problems – ANDAs have dried up, USFDA has tightened regulatory approvals and has introduced high fees. BRICS does not seem to be taking off in the manner anticipated. Clinical trial industry is in loggerheads with media and the regulatory bodies. The Indian pharma sector does not seem to find innovative molecules. The Fixed Dose Combination (FDC) era is being frowned upon and there is a move by DCGI to cancel over 1000 FDCs. The cost of marketing in India is increasing alarmingly. The global exports to the deregulated market are shrinking with price war among our own manufacturers. The government cannot be a silent spectator when one of the successful industrial sectors for India is seeing some kind of recession. The government should reach out and work out schemes and fund research in a much bigger way, particularly for the services sector.

True, there are several challenges in the pharma industry. However, in order to address all these issues, GOI should bring a synchronisation and project India pharma as a flagship on the global platform. India should ne portrayed as the leader in the pharma world. For this, R&D should be given the greatest impetus, expecially in the form of subsidies. In other words, the govt should back the whole R&D set up. Additionally, the Indian pharma companies, especially biotech, should be viewed as the commercially viable venture like the R&D segment in the US. Banks should be coming up as the venture capital. active pharmaceutical ingredients (API) had always been the strong point for China, but now they are catching up with the formulation development also. Therefore, we need to gear up, otherwise we will lose to China. Thus, R&D is the future of the country. Therefore, pharma colleges, universities, and educational institutes providing PHD programmes should venture into research facilities. This will facilitate and help in building the R&D culture and environment of India. T S Jaishankar

Founder Chairman - CIPI, Managing Director, Quest Life Sciences P Ltd

Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

News, Views & Analysis

GE launches modular biopharmaceutical factory, KUBio GE Healthcare recently introduced KUBio™, an off-the-shelf, modular factory designed to save manufacturers of biopharmaceuticals both time and money. KUBio’s pre-made modules, which are assembled at a customer’s chosen site to make a fully functional ready-to-run bioprocessing facility, are significantly faster to install than constructing a traditional factory. The modules are equipped with GE Healthcare’s technologies for the startto-finish manufacture of

Loeillot

biopharmaceuticals. KUBio will help manufacturers respond to local healthcare

Pharma players should aim at retaining exisiting talent: Survey VUEXPRESS-ONLINE industry survey conducted by city-based Harneedi. com, a jobsite for Healthcare and pharma, highlighted the employees’ opinion and preferences out lining employer-employee association in newer dimensions. “Dissatisfaction among one partner (employee) of this association is a matter of concern; however, there is a paradigm shift in HR orientation in recent times,” mentioned Richard D’silva, D’silva Senior Manager – Marketing, Harneedi.com. The survey consisted of questionnaire administered to 400 employees that included pharma, biotech, clinical research and healthcare employees. D’Silva summarised, “Employees feel that the management has failed to

provide appropriate training to maximise the employee’s strength, which is required to perform effectively in the changing environment.” At the end, overall job satisfaction indicates positive traits of pharma industry but 62 per cent still are not happy due to various reasons. D’silva added, “Players should aim at retaining existing talent; this could help the companies manage talent loss. This may implicate advance hiring, on-board processing, giving more importance on apprenticeships, internships, skills upgrade, offering financial incentives and other personnel development activities. Policy designers need to redefine their employee value proposition to ensure long-term association for the success.”

needs and bring these potentially life-saving treatments to market more quickly. KUBio is a fully functional offthe-shelf bioprocessing facility specifically designed to meet cGMP requirements while optimising manufacturing flexibility and productivity. The 1200 m2 facility is pre-fabricated and delivered with a complete readyto-use production line, based on GE Healthcare’s Ready-to-Process™ single-use technologies. With a total planning,

delivery and construction time of 14 - 18 months, compared to the traditional 24 - 36 months, both timeto-market and level of capital investment are significantly reduced. The first modular facilities to be introduced will be configured for the manufacture of monoclonal antibodies. GE Healthcare also plans to introduce modules for the manufacture of other biopharmaceuticals. “With KUBio our customers will be able to cut months off the typical construction

time, and greatly streamline the whole construction process. We are already seeing interest from a wide range of customers, from governments wanting to develop in-country manufacturing capability right through to pharmaceutical companies wanting to expand production capacity in new locations. KUBio is an industry game-changer that will help them do just that,” said Olivier Loeillot, General Manager Enterprise Solutions, GE Healthcare Life Sciences.

Mylan Lab chosen as leading Dr Reddy’s plans EU launch supplier of ARV drug to NACO major Mylan’s people access to high-quality for biosimilar PHARMA India-based subsidiary Mylan medicines and helping to ensure Laboratories Ltd has been access to high quality, affordable cancer selected as a leading supplier ARVs. “Only through access to of Anti-retroviral (ARV) drugs these vital medicines can we treatment to India’s National AIDS stem the tide of HIV/AIDS in DR Reddy’s Laboratories is planning to launch a biosimilar version of Roche’s non-Hodgkin’s lymphoma treatment rituximab in Europe. The company is in talks with European regulators about the potential launch of Reditux, which is the world’s first biosimilar monoclonal antibody and would be commercialised in partnership with Merck Serono. This comes as part of a wider corporate strategy to further explore the commercial potential of biosimilars, having signed partnerships with GlaxoSmithKline and Merck Serono in this area. The Merck Serono partnership was agreed in June 2012 and will see the companies developing new biosimilars in the field of oncology, with Dr Reddy’s handling development until the end of phase I testing.

Control Organisation (NACO). NACO is a division of India’s Ministry of Health and Family Welfare and is responsible for overseeing HIV/ AIDS control programmes in India. NACO’s objective is to halt and reverse the HIV/AIDS epidemic in India over the next five years through Bresch integrated programmes for prevention, care, support and treatment. NACO manages 35 HIV prevention and control societies, which implement NACO’s programmes at the state level and manage more than 350 ARV treatment centres. Heather Bresch, CEO, Mylan, said that the company’s mission is to provide the world’s 7 billion

India and around the world. We are honoured that Mylan has been selected as a significant supplier to NACO and look forward to helping this critical organisation achieve its mission,” Bresch said. Approximately one-third of HIV/ AIDS patients in developing countries depend on a Mylan ARV product and Mylan has recently entered the Indian commercial market, starting with a portfolio of ARV drugs. Mylan’s wide range of ARV products includes active pharmaceutical ingredients and 43 first- and second-line finished doses, nine of which are paediatric products.

LifeCell partners with Sequel LIFECELL International has partnered with Sequel Logistics, India - a specialist in critical logistics, to offer personalised shipment service of the umbilical cord blood and tissue samples. This unique initiative is critical in healthcare logistics whereby stem cells of the new born will be shipped through Sequel’s partner airlines via the next available flight to LifeCell’s processing and storage facility in Chennai. This system is an important aspect to stem cell preservation since the sample will reach the laboratory for testing and processing within 24 hours from metro cities and 36 hours from non-metro cities. This first–of-its-kind initiative by LifeCell offers the fastest time by any company in the industry in reaching the collected samples to the laboratory for processing. Mayur Abhaya, Managing Director and CEO, LifeCell International, said “LifeCell endeavours to provide the industry, with leading and innovative offerings to improve the service excellence and this partnership with

Sequel is yet another step in that direction. We can now use Sequel’s partnerships with airlines to ensure the immediate shipment of the stored stem cells from the nearest airport, thereby improving the yield and viability of stem cells.” “Focussing only on such critical logistics requirements, Sequel ensures a consistent 24 to 36 hours TAT (Turn Around Time), for any shipment, picked up from anywhere in the country, at any time of the day. Through this unique and close partnership, we strive to provide LifeCell and its valued customers, a service that they can truly benefit for a lifetime,” said Rajkumar, Founder Director and COO, Sequel Logistics. LifeCell would be offering ‘personalised shipment’ to its customers with immediate effect. This service will now be available throughout the countrywide network of LifeCell with presence in over 100 cities and towns.

Bosch to showcase products at Pack Expo 2012 AT Pack Expo 2012 in Chicago, USA, Bosch Packaging Technology plans to showcase several new technologies for the pharmaceutical, food and confectionery industries. Bosch Packaging Technology plans to introduce a range of innovations to the North American market: the bar packaging line, the SurePOUCH cleanfill machine (SPC), and the compact inspection unit KKX 3900 for capsules. The new inspection unit KKX 3900 for capsules also has its debut in North America. With this, Bosch underlines the substantial expansion of its inspection technology portfolio for the pharmaceutical industry. Based on

X-ray technology, the machine serves as a system for comprehensive 100-per cent weight and quality control. The small inspection unit is equipped with soft X-ray technology and an associated sensor for image creation. “The KKX 3900 is universally applicable and, apart from filling weight control, provides further advantages. For the first time, an inspection unit is capable of simultaneously checking all quality features such as weight, foreign particles, deformation of capsule top and bottom, as well as length,” explained Melanie Beck, Product Manager, Bosch Packaging Technology.

Modern Pharma•16-30 Sept ember 2012

News, Views & Analysis

Orchid enters into agreement to transfer its Penicillin & Penem API business CHENNAI-BASED global pharma major, Orchid Chemicals & Pharmaceuticals (Orchid) has recently entered into a Business Transfer Agreement (BTA) with Hospira for the sale and transfer of Orchid’s Penicillin and Penem API business and the API facility located in Aurangabad (Maharashtra) together with an associated process R&D infrastructure located in Chennai for a total cash consideration of approximately $ 200 million. This business transfer includes the related Penicillin and Penem product portfolio and pipeline. Approximately 830 employees would be transferred to Hospira as part of this business transfer. As some of Orchid’s API requirements for the non-penicillin, NonPenem, Noncephalosporin

(NPNC) business were supplied by the Aurangabad facility, Hospira will supply such NPNC API to Orchid through a long-term agreement that both companies have entered into. This agreement builds on the existing product development and commercialisation relationship between Hospira and Orchid. Orchid would continue to supply its Cephalosporin APIs to Hospira in accordance with the long-term supply contract. This business transfer agreement also demonstrates Orchid’s ability to build value in its chosen product domains and successfully monetise them to create value for the stakeholders. The proceeds from this business transfer will be utilised for de-leveraging Orchid’s debt position and also pave the entry

Cole-Parmer releases its 6th annual catalog for the India marketplace A customer’s favourite returns as Cole-Parmer releases the latest (6th) edition of its popular India catalog. The new 2012 catalog underscores the company’s reputation of bringing the latest, hard-to-find products to customers. Aggarwal The 288page catalog has numerous unique and new products, as well as returning favourites. Users can select highly efficient laboratory essentials, lab equipment, fluid handling and process equipment and find exactly what they need for their application - from development&D to pilot plants to scale-up. The catalog also has convenient dual pricing featuring custom duty exempt prices and prices in rupees, making it handy for users to set up supply contracts. At the catalog launch, Rakesh Aggarwal, Director of Operations, Cole-Parmer India, said, “We are working in an arena of customisation where customers prefer to have scalable solutions tailor-made to their application needs, and we offer this choice. Apart from offering this option of customisation, we widen the horizon by giving customers the convenience of product bundling combined with pre- and postsales service and expert application support.” The catalog includes a wide portfolio of products to address customers’ demanding manufacturing and process applications needs.

for the company’s foray into newer product verticals. “Orchid’s business model has crossed many

Rao

milestones over the years. With investments across the pharma value chain ranging from research to API & FDF manufacturing, we have harnessed key product opportunities and built a

Given the current scenario, it is a prudent decision for Orchid to monetise these verticals and bring in cash to deleverage its debt position and fund newer growth horizons.

strong revenue base. Moving on, we would like to replicate this success by creating more niche product and therapeutic verticals, which will continue to power our growth. This business transfer agreement with Hospira will help us fast track our future growth while maintaining a healthy debt

profile in our balance sheet. Given the current scenario, it is a prudent decision for Orchid to monetise these verticals and bring in cash to deleverage its debt position and fund newer growth horizons,” said K Raghavendra Rao, CMD, Orchid Chemicals & Pharmaceuticals Ltd. The transaction has been unanimously approved by Hospira’s and Orchid’s Boards of directors. It is subject to Orchid’s shareholders, regulatory and legal approvals, as well as customary closing conditions. Assuming all necessary approvals are secured, the transaction is expected to be completed in the third quarter of Orchid’s 2012-13 fiscal year, corresponding to the fourth quarter of the calendar year 2012.

Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

News, Views & Analysis

Abbott to collaborate with Astellas in CMV vaccine trial ABBOTT has signed an agreement to collaborate with Astellas Pharma Global Development in a Phase 3 clinical trial for ASP0113 (TransVaxTM), an investigational vaccine licensed from Vical Incorporated for preventing Cytomegalovirus (CMV) reactivation in transplant patients. Under the agreement, Abbott’s RealTime CMV assay, which is performed on the Abbott m2000 System and intended for investigational

use only, will be used to monitor patients for CMV viral load in order to assess the vaccine’s efficacy. “Our agreement with Astellas gives us an opportunity to collaborate with another leader in the healthcare industry to better monitor patients to ensure proper treatment. Abbott’s investigational CMV test will be used as an important aid in assessing the efficacy of this promising vaccine, which could significantly improve the

overall outcome of transplant procedures,” said John Coulter, Head - Molecular Diagnostics Business, Abbott. This agreement represents the fourth partnership that Abbott has announced in the last 12 months with a leading pharmaceutical company. Recent collaborations include ones with Pfizer, GlaxoSmithKline and Merck focus on the development of companion diagnostic tests for use in selecting patients for novel oncology therapeutics.

Pharma, medical technology are attractive investments in emerging markets: Reports PHARMACEUTICALS, medical technology and healthcare infrastructure lead the list of attractive healthcare opportunities in emerging markets, according to The Boston Company Asset Management.

A recent white paper by The Boston Company Asset Management; ‘Global Wealth Creation: The Impacts on Emerging Markets Health Care,’ predicts that the healthcare segments are poised to benefit from continuing

economic development in emerging markets. These include the projected growth of the pharmaceuticals industry in Russia and the overwhelming effects healthcare expenses have on rural poverty in India.

Roche committed to innovation and growth THE investor event in London will showcase the progress of Roche’s late-stage pipeline. As many as 19 late stage clinical trials are expected to read out over the next 18 months, 12 of which are investigating New Molecular Entities (NMEs). In addition, three NME projects could reach the Lifecycle Investment Point (LIP) to move into late-stage development this year. Despite the promising increase of late–stage projects, Roche intends to keep its R&D budget stable by implementing continued productivity

improvements and rigorous portfolio prioritisation. “Roche’s strategy is based on developing differentiated

Schwan

Finland University to set up research facility at Mohali IN what comes as a boost for state’s knowledge sector, a technical university of Finland has approached the Punjab government to set up a world-class biotech and pharma research lab at Mohali. A delegation of Finnish entrepreneurs, led by Indian-origin entrepreneur Atul Khanna, called on Punjab Deputy Chief Minister Sukhbir Singh Badal and expressed their interest in this regard. The ` 30 crore-project lab, proposed in Mohali, will promote R&D linkages with the industry and will provide scope for translational, application-based research. The lab will come up on 3 acres of land and its construction will be completed within 12 months. Assuring all possible support to the delegation, the Punjab Technical University worked out the process for a joint venture in this regard.

medicines and diagnostics in areas of high unmet need that bring true medical benefit to patients. More than 60 per cent of our pharmaceutical pipeline projects are coupled with the development of companion diagnostics in order to make treatments more effective. The recent launches of our cancer medicines Perjeta and Zelboraf are examples of the concept of personalised healthcare becoming reality,” said Severin Schwan, CEO, Roche.

Wockhardt launches generic anti-depressant Wellbutrin® SR WOCKHARDT has received final approval from the US FDA for marketing 100 mg, 150 mg and 200 mg 12-h extended release tablets of bupropion HCl, which is used in the treatment of depression. Bupropion is the generic name for the brand Wellbutrin® SR, marketed in the US by Glaxo Smithkline. Wockhardt is launching the product immediately. According to IMS Health, the total market for this product in the US is about $ 268 million. Depression is a rapidly growing condition globally and bupropion is one of the more used drugs for treating this condition. Dr Habil Khorakiwala, Founder Chairman & Group CEO, Wockhardt, “Extended-release technology is a core competency of Wockhardt’s R&D and they have consistently risen to the challenge of developing these technically challenging products.” Wockhardt will be manufacturing the extendedrelease tablets of Bupropion 12-h at its facility in Waluj, India. The technology for the tablets was developed in-house.

In Brief Strides receives US FDA approval for Vinorelbine

ONCO Therapies Ltd, a wholly owned subsidiary of Strides Arcolab Limited (Strides) has received final ANDA approval for Vinorelbine Injection USP, 10 mg/mL packaged in 10 mg/1 mL and 50 mg/5mL single-dose vials. Vinorelbine is part of the oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch.

Perrigo and Tris Pharma launch store brand version of Delsym®

PERRIGO Company and Tris Pharma, Inc announced the commercial launch of a major new store brand product. The new product is equivalent to Delsym® extended-release oral liquid suspension containing dextromethorphan polistirex and will be marketed under major US retailer and wholesalers’ store brands or own label brands. Joseph C, Chairman, President and CEO, Papa Perrigo, stated, “We are excited to partner with Tris Pharma and bring this first ever store brand extended release liquid cough/cold product to our retail and store brand customers’ portfolios in time for the season.”

Salix Pharma still to get USFDA approval for crofelemer new drug application

GLENMARK’S collaborative partner, Salix Pharmaceuticals announced that the FDA has advised the company that the New Drug Application for crofelemer 125 mg tablets, indicated for symptomatic relief of non-infectious diarrhoea in patients with HIV/AIDS on anti-retroviral therapy, is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2012. Glenmark has exclusive rights for crofelemer in diarrhoea indications in nearly 140 countries including India and is the sole API supplier globally for crofelemer.

Manipal varsity to offer Masters in Pharmaceutical Medicine MANIPAL University will offer Master of Science in Pharmaceutical Medicine from October. Hibernia College, Dublin – in collaboration with Manipal College of Pharmaceutical Sciences, Manipal University will provide a programme in Master of Sciences in Pharmaceutical Medicine. Further, this programme will provide a systematic understanding of drug development process from the initial discovery through R&D to the regulatory

approval process and commercialisation. This will help students gain valuable business and management expertise required for senior positions in the pharmaceutical industry. The duration of the course is two years and professors from the Dublin College will teach. In addition, the students who have completed BPharm, MBBS, and BDS can enroll for the course. Further, employees who are working in pharma companies are also eligible.

Aurobindo receives approval for hypertension capsules AUROBINDO Pharma Ltd has received final approvals from the USFDA to manufacture and market amlodipine besylate and benazepril hydrochloride capsules 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg (ANDA 202239). The products are ready for launch. Amlodipine besylate and benazepril hydrochloride capsules 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg are the generic bioequivalent to the reference listed drug Lotrel® capsules of Novartis Pharmaceuticals Corp. Amlodipine besylate and benazepril hydrochloride capsules are indicated for the

treatment of hypertension in patients not adequately controlled on monotherapy with either agent and falls under the Cardio-Vascular (CVS) therapeutic category. The annual sales of amlodipine besylate and benazepril hydrochloride capsules is approximately $ 500 million for the 12 months ending March 2012, according to IMS. The products have been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India. Aurobindo now has a total of 158 ANDA approvals (133 final approvals including 1 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA.

Modern Pharma•16-30 Sept ember 2012

News, Views & Analysis

Lucentis® confirms long-term efficacy and safety profile NEW data for Lucentis® (ranibizumab), anti -VEGF therapy licensed across three ocular indications, show that individualised treatment with Lucentis provides sustained improvement in vision with a low number of injections. “Lucentis has become the standard of care in wet AgeRelated Macular Degeneration (AMD) and has helped to significantly improve vision in a majority of patients with this disease. These new data confirm that an individualised treatment approach can lead to optimal improvements in vision

with a low average number of treatments, thus ensuring that patients with retinal diseases are not over or under treated. In addition, these data add to the

Lucentis also demonstrated benefits in visual acuity outcomes in patients with visual impairment due to Choroidal Neovascularisation (CNV) secondary to Pathological Myopia (PM).

well-characterised safety profile of Lucentis,” said Tim Wright, Global Head of Development, Novartis Pharma. Lucentis also demonstrated benefits in visual acuity outcomes in patients with visual impairment due to Choroidal Neovascularisation (CNV) secondary to Pathological Myopia (PM). Lucentis is currently not approved to treat this condition. Novartis will submit for regulatory approval in this indication in the European Union in the third quarter of this year and in Japan by the end of 2012.

Spectrum Pharmaceuticals celebrates 10 years SPECTRUM Pharmaceuticals, a biotechnology company with a primary focus in oncology and haematology, marked its ten-year anniversary in business. The milestone is being celebrated by employees in the US and a growing number of locations abroad as Spectrum expands its worldwide presence. Spectrum is headquartered in Henderson, Nevada, with its R&D facility located in Irvine, CA; additional locations include Spectrum Pharma Canada and the Company’s subsidiary, OncoRx, in

Mumbai, India. Plans include establishing and expanding offices in Japan and in Europe to support international operations. “Spectrum has dramatically transformed itself over the past decade from a start-up company with no approved products to a dynamic industry leader with two approved drugs, substantial R&D opportunities and a successful commercial infrastructure,” said Rajesh C Shrotriya, MD, Chairman, CEO, and President, Spectrum Pharmaceuticals, who has led Spectrum from its inception.

European approval for Pfizer’s kidney cancer drug Inlyta Venom from European Commission recently sunitinib (the company’s Sutent) or growth, vascular angiogenesis world’s deadliest THE granted marketing authorisation a cytokine. Inlyta, a kinase inhibitor, and progression of cancer spider can cure for Pfizer’s Inlyta (axitinib) for the is an oral therapy that was designed (tumour spread). The drug has treatment of adult patients with to selectively inhibit Vascular also been approved in a number impotency advanced Renal Cell Carcinoma Endothelial Growth Factor (VEGF) of other countries, including (RCC), a type of kidney cancer, after failure of prior treatment with

A drug made from the venom of the world’s deadliest spider could hold the cure for impotency, researchers have claimed. Researchers from Brazil and the US found that venom from the Brazilian Wandering Spider can produce toxins that could have a blood-boosting effect and can combat erectile dysfunction within 20 minutes of entering the body. The spider is responsible for killing more people than any other arachnid. Victims usually die within an hour of being bitten. Tests carried out on rats show the venom boosts performance by increasing the release of nitric oxide, a chemical that dilates blood vessels and improves blood flow. This is similar to how existing impotence drugs work. Although drugs such as Viagra, Cialis and Levitra have revolutionised treatment for impotency in the last ten years, around 30 per cent of men who take them see no improvement. A drug made from spider venom could prove to be an effective alternative. Researchers extracted the toxin, called PnTx2-6, from the deadly venom and injected it into rats which had age-related erectile dysfunction. They found the toxin boosted erections by triggering the release of nitric oxide, which boosts circulation in the male genitals by helping blood vessel walls relax. “The decrease in erectile function associated with age was partially restored 15 to 20 minutes after injection with PnTx2-6,” the researchers were quoted as saying by the paper. The study was published in The Journal of Sexual Medicine.

receptors 1, 2 and 3, which are proteins that can influence tumour

Switzerland, Japan, Australia and Korea.

Canada,

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News, Views & Analysis

Marken opens two pharma depots in New York & Germany MARKEN recently announced the completion of the first phase of its plan in order to create a global pharma depot network that will allow it to satisfy its clients’ needs for global distribution. Two new depots have been completed: one in Frankfurt, Germany and one in Farmingdale, New York. The launch of these two central depots, when added to the existing operational depots in Singapore, Mexico and Argentina and further supplemented by its own third party depot network,

now completes phase I of the global Marken depot network plan. This network has been built based on an extensive analysis of client needs as well as geographical needs,

allowing large phase III clinical trials to be conducted in a cost efficient and optimised manner. “Having these two new central depots allows

us to serve our clients with global distribution services and, more importantly, to serve our clients who seek comprehensive and efficient global distribution. Phase I is complete. We are now pushing forward with phase II, which will include more depots in key countries around the world such as China, Brazil and Russia,” said Gerit Offenhauser, Senior VP, Clinical Trials Distribution, Marken.

Aarti Industries Board approves demerger of manufacturing business PIRAMAL The Board of Directors of Aarti Industries Ltd, a leading manufacturer and exporter of chemicals and pharmaceuticals, recently approved the scheme for arrangement for demerger of manufacturing business undertaking of Anushakti Chemicals and Drugs Ltd (Anushakti) into Aarti Industries Ltd (Aarti). The Board of Director during its meeting held recently approved the share entitlement ratio of 3:5. Under the said scheme,

shareholders of Anushakti would be entitled to get three equity shares for ` 5 each in Aarti for every five equity shares of ` 10 each held in Anushakti. Anushakti is an associate company of Aarti, with Aarti holding 49.6 per cent equity stake in Anushakti. Commenting on the development, Rajendra V Gogri, CMD, Aarti Industries Ltd, said “In an endeavour to consolidate our operations and as a part of our overall

SMS service in offing for public awareness on cheaper drugs THE Department of Pharmaceuticals in the Ministry of Chemicals and Fertilizers is planning to launch a SMS service providing information about affordable alternatives to medicines prescribed by doctors, the government recently announced. This was stated by Ghulam Nabi Azad, Health Minister, in a written reply in Lok Sabha on whether such a scheme benefiting poor patients was being proposed by the government. The SMS facility could help poor patients find cheaper alternatives to medicines prescribed by doctors, he said, adding that the details of the service are being worked out. In reply to another question on drug pricing, Azad said the Corporate Affairs Ministry has made a study on the production cost of certain drugs Azad and their market prices which shows there is a huge mark up in the cost of production vis-a-vis the sale price of drugs. Azad said the Ministry of Health and Family Welfare has sought

that all 348 drugs listed in the National List of Essential Medicines, 2011 should be brought within the purview of the Drug Price Control Order (DPCO). “The DPCO Department of Pharmaceuticals has already been requested in this regard,” the Minister said. In reply to a question, Azad said the Department of Pharmaceuticals has prepared a draft Uniform Code of Pharmaceutical Marketing Practices (UCPMP) to be adopted voluntarily following reports of some pharma companies making promotional expenses to doctors. He said a Parliamentary Standing Committee has also recommended decisive action by the Department of Pharmaceuticals in making the uniform code mandatory so that effective check could be put on huge promotional costs and the resultant impact of add-on costs on medicine prices.

corporate restructuring, we have proposed to demerge the manufacturing operations of our associate company Anushakti into Aarti. Apart from synergies derived in respect of common products, the said restructuring shall also help to increase volumes of existing range of products and will also facilitate addition of newer products with diverse end usage into fuel additives, etc having high growth possibilities.”

Sun Pharma recalls one lot of nimodipine capsules SU N Pharmaceutical Industries, Inc has recalled one lot of nimodipine capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Sun Inc commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot as identified by a customer complaint. Nimodipine capsules, 30 mg, are used to decrease problems due to subarachnoid haemorrhage. The crystallisation of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability. Although clinical health implications are unknown, use of the product when the nimodipine has crystallised in the capsule may be of great clinical significance. The product may no longer be bioequivalent and may potentially affect patients, who are being treated for a medical emergency.

In Brief Roche receives FDA clearance for herpes simplex virus type 1 and 2 tests

ROCHE recently announced that it has received clearance from the US FDA for its IgG Antibody to Herpes Simplex Virus (HSV) types 1 and 2 assays for use on Cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. “These are the first automated type-specific herpes tests available for integrated analyser platforms, which will enable labs to integrate efficient herpes testing into their existing workflow. The approval of the type-specific assays also means healthcare providers now have another tool to give them greater confidence in their diagnosis and overall patient care,” said Randy Pritchard, VP-Marketing, Roche Diagnostics Corporation.

FDA places clinical hold on Idenix Pharma product

IDENIX Pharmaceuticals Inc recently announced that it received verbal notice from the US FDA that a clinical hold has been placed on IDX19368, the company’s next-generation nucleotide polymerase inhibitor under development for the treatment of Hepatitis C Virus (HCV) infection.

Spectrum Pharmaceuticals acquires Allos Therapeutics

SPECTRUM Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in haematology and oncology, has successfully completed the acquisition of Allos Therapeutics, Inc (Allos), on September 5, 2012 through a ‘short-form’ merger of Sapphire Acquisition Sub, Inc, a wholly-owned subsidiary of Spectrum, with and into Allos with Allos surviving the merger and continuing as a wholly-owned subsidiary of Spectrum.

Jazz Pharma sells women’s health unit for $ 95 million

SWEDEN’S Meda has expanded its presence in the US by acquiring the women’s health business of Jazz Pharmaceuticals for $ 95 million. The purchase involves a portfolio of six pharmaceutical products, which had net sales of $ 30.4 million in 2011. About half of that total came from Elestrin (estradiol gel) for the treatment of hot flashes associated with menopause.

INJEX Pharma AG signs exclusive distribution agreement for US

‘21 Medical Technologies LLC.,’ (21 MT) located in Fort Lauderdale, Florida, has got the exclusive rights to market and distribute INJEX30 systems in the US. INJEX30 syringes without a needle may be used in multiple medical, cosmetic and anaesthetic applications and marketed via traditional pharmaceutical and emerging life science modalities.

Dubai to host Cold Chain 2012, Optimization for food and pharma

COLD Chain 2012, Optimization for food and pharma will be held at Dubai-UAE, on October 2-3, 2012. This summit seeks to address the current state of cold chain infrastructure in different regions and learn about innovations in active and passive cold chain. This summit will comprise of 2 days full of case studies and interactive sessions. The discussions and expertise shared through this conference will enable cold chain heads and engineers to introspect, analyse and update their own logistics and transport approach, which might help with the essential elements deliver value to their customers.

Medivir buys antiviral research programmes from Novadex Pharma

MEDIVIR AB, a research-based pharmaceutical company focussed on infectious diseases, has acquired the assets of preclinical research of Novadex Pharmaceuticals AB, a biotech company developing small molecular therapeutics against important human diseases based in Sweden. The acquisition includes Intellectual Property Rights (IPR) and so-called ‘pro-drug’ technologies, which means that Medivir strengthens its position in hepatitis C research and its technology platform.

Sun Pharma arm Caraco gets US FDA nod to resume operations

SUN Pharmaceutical Industries recently announced that its subsidiary, Caraco, has received clearance from US FDA to resume operations at its manufacturing facility and packaging sites at Detroit and Wixom, in Michigan, US and start production of two drugs.

Modern Pharma•16-30 Sept ember 2012

News, Views & Analysis

Anti-cancer drug using nanoparticles shows promising start SPANISH researchers have developed on a nanometric scale a new drug that combines photothermia and chemotherapy to help fight cancer. Until now, this new drug has been applied to human glioma cell cultures in the laboratory, and the results are particularly interesting for the treatment of melanoma and solid tumours of the nervous system such as gliomas. The work was co-ordinated by Professor Eduardo Fernández Jover (Miguel Hernández

University of Elche) and Pablo Botella, Researcher, Institute of Chemical Technology of Valencia. The new drug consists of hybrid particles containing clusters of gold nanoparticles protected by a covering of porous silica that incorporates molecules of the antitumour drug camptothecin. The gold nanoclusters have photothermal activity, absorbing the light generated by a biomedical laser. Botella explains that while organic tissues are virtually transparent to this radiation,

its absorption by the gold nanoclusters causes a large local temperature increase. “When this occurs within a cancer cell, the high internal stress leads to its destruction,” he explains. The study has completed its initial phase conducted on cell cultures and, currently, there are plans to develop the next preclinical stage on animal models of skin cancer and gliomas. However, the researchers say it is still early days to start on humans.

Global CRO market to grow at 10.7 per cent TECHNAVIO’S analysts forecast the Global Contract Research Organisation (CRO) market to grow at a CAGR of 10.7 per cent over the period 20112015. One of the key factors contributing to this market growth is the increase in outsourcing of R&D activities. The Global CRO market has also been witnessing forward and backward integration by vendors. However, the strict government regulations on drug development could pose a challenge to the growth of this market.

TechNavio’s report, the Global Contract Research Organisation Market 2011-2015, has been prepared based on an in-depth analysis of the market with inputs from industry experts. The report covers the Americas, and the EMEA and APAC regions and focuses on the US, Latin America, Western Europe, Eastern Europe, China, and India; it also covers the outsourcing of R&D services to CROs by global pharmaceutical and biopharmaceutical vendors. The report also includes a

discussion of the key vendors operating in this market. Key vendors dominating this market space include Charles River Laboratories International Inc, Covance Inc, Pharmaceutical Product Development Inc, and Quintiles Transnational Corp. Other vendors mentioned in the report: Icon Plc, Kendle Inc., Parexel International, PharmaNet Clinical Services, Piramal Healthcare Ltd, Ricerca Biosciences LLC, Siro Clinpharm, Takeda Pharmaceutical Co Ltd, and WuXi App Tec.

In Brief US FDA approves Pfizer drug for rare blood cancer

THE US FDA recently approved Pfizer’s Bosulif drug to treat a rare form of blood and bone marrow cancer that causes a buildup of unhealthy white blood cells. FDA approved the drug for patients with a genetic mutation, known as the Philadelphia chromosome, who do not respond to other cancer therapies, including Novartis’ Gleevec. FDA approved Bosulif based on a Pfizer study showing 34 per cent of patients treated with the drug responded within the first six months of treatment.

FDA sued by public citizen over safety of an Alzheimer’s drug

A consumer advocacy group, which demanded last year that FDA pull the Eisai drug’s 23 mg dose, sued the agency recently for action. The group said that the high dose has more dangerous, potentially deadly side effects including vomiting, which in Alzheimer’s patients ‘can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.’

Pharmexcil to hold iPHEX 2013, in Mumbai from April 24 to 26, 2013

THE Pharmaceuticals Export Promotion Council of India (Pharmexcil) will organise the iPHEX 2013, the mega exhibition of Indian pharmaceutical products and technologies in Mumbai from April 24 to 26, 2013. Over 400 international buyers including regulators are expected to visit the mega show in Mumbai.

Emerging pharmaceutical markets in the Middle East

The majority of Middle Eastern pharmaceutical markets are growing at faster rates than Western Europe and North America, creating opportunities for pharma. Meanwhile, regulatory, economic and demographic shifts are transforming these markets. The report presents and analyses exclusive survey data from 126 industry executives on industry incentives, commercial environment and partnership plans. Each country’s macroeconomic, pricing and reimbursement and healthcare environment is described and compared. An attractiveness index allowing comparison of the five countries along four dimensions is also presented.

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News, Views & Analysis

Lilly Diabetes launches mobile application for people with type 1 diabetes LILLY Diabetes recently announced the release of a new mobile application designed for caregivers and healthcare providers who support people with type 1 diabetes. The Lilly Glucagon Mobile App is a tool to teach how to use Glucagon for injection, through simulated practice. Glucagon, 1 mg (1 unit), is indicated to treat severe hypoglycemia that may result in loss of consciousness

(insulin coma). The app is designed to help people be more prepared, and also provide an opportunity to store locations and expiration dates of their Lilly Glucagon Emergency Kits. The Lilly Glucagon Mobile App is now available on the iTunes® store as a free download for iPhone® or iPad® mobile devices. “Lilly Diabetes is committed to developing personalised solutions to

3M extends filtration range for enhanced process scaling LEVERAGING 40 years of expertise and innovation in bioburden, biomass and fineparticle reduction filtration, the purification division of 3M, the diversified technology company, has enhanced its successful encapsulated single-use depth filtration range by releasing new scaling tools. The new Zeta Plus scaleup capsule filters from 3M are innovative in that they are easy to use and allow predictable performance when scaling from laboratory fermentations during process development to commercial biomanufacturing and purification. The three new Zeta Plus capsule filters - E0170, E0340 and E1020 - have a filtration surface area of 170cm 2 , 340cm 2 , and 1020cm 2 , respectively. The capsules complete the existing disposable filtration range, which now extends from

the 25cm2 BC25 model to units of 11.2m2 or 17.5m2, configured using capsules with a positive cam locking mechanism and manifolds in a range of holders. For applications requiring an even larger filtration area, the Zeta Plus encapsulated system multi-round holder combines multiple 11.2/17.5 m2 filter carousels. The new Zeta Plus capsule filters can be used in parallel or in series, and provide the flexibility to use different filter media at the same time. The capsules have integral legs for plug-and-play operation or stacking and are also moulded in translucent plastic for easy monitoring of the filtration process. The new capsules have been engineered to minimise holdup volume, which reduces the buffer consumption for pre-flushing and improves process yield.

help people with diabetes achieve their treatment goals and improve their outcomes. The Lilly Glucagon Mobile App leverages the power and reach of mobile technology, providing another opportunity to support people living with type 1 diabetes. Lilly Diabetes is constantly striving to create new and better tools to support the diabetes community in a variety of ways,” said

ACG Pam launches ‘Op-T’ Turret ACG Pam has launched advanced turret, ‘Op-T’ – a patented D type turret for legacy 6100 single rotary tablet compression machine. The ‘OpT’ turret is interchangeable with any Legacy 6100 single rotary tablet machines in the market. This new 46-station turret can deliver 20 per cent more output compared to the current 37 station standard turret. ‘OpT’ can accommodate a round tablet size of up to 18 mm and 21 X 10 mm size for shape tablets. The special die shapes on the die-table are replaceable depending on tablet shapes. ‘Op-T’ is compliant with EURO or TSM standard punches and special dies developed by ACG Pam. ‘Op-T’ is a cost effective solution for increasing output without compromising on tableting parameters – it meets the requirements of customers looking for higher output for the existing product with optimised dwell time and speed on D turret,” said J S Mehta, VP - Technology, ACG Pam.

Bosch introduces new capsule filling machines BOSCH Packaging Technology flexible processing of a wider range of has introduced two capsule filling products with a higher yield. Melanie machines, GKF 702 for small and Beck, Product Manager - Packaging medium-sized batches as well as GKF Technology, Bosch said, “The GKF 702 offers the 2500 equipped same flexibility with a micro and user-friendly dosing station. The new design of GKF 702 operation as The new design of GKF 702 provides provides improved ergonomics and the GKF 701. accessibility to meet the growing This makes it improved needs in pharmaceutical industry possible to fill very ergonomics and accessibility small batches for for flexibility. And GKF 2500 is to meet the pharmaceutical or suitable for flexible processing of growing needs in clinical purposes a wider range of products with a pharmaceutical under realistic higher yield. industry for production flexibility. conditions. The The unit can GKF 2500 also be used in the lab for small meets all requirements for batches, parameters required for pharmaceutical production and future production operations can o f f e r s manufacturers a be comprehensively simulated and gentle filling process with defined. GKF 2500 is suitable for need-based application.”

Matt Caffrey, US Product Brand Director, Marketing Speciality, Lilly Diabetes. The Lilly Glucagon Mobile App includes information about severe hypoglycemia and glucagon, simulated practice demonstrating how to prepare and inject glucagon, visual and audio emergency instructions, tools to keep track of kit locations and alerts for expiration dates and important safety information.

‘Alukbiss – alu look film’ from ACG Pharmapack wins INDIASTAR 2012 ACG Pharmapack, a member Chairman of the Jury; Prof G of ACG worldwide wins G Ray, Professor & HeadINDIASTAR 2012, an award IDC, IIT-Mumbai; Hemant for excellence in packaging. Ranadive, Production Head, Alukbliss – alu look film from FCB Ulka Advertising Pvt Ltd; ACG Pharmapack won this and Pradyumna Vyas, Directorin the ‘Packaging Material and National Institute of Design (NID), Ahmedabad Adjunct’ category. ACG, Pharmapack Recently, Indian was a unanimous Institute of Out of a total choice. Packaging, a 507 participants “INDIASTAR universally reputed across categories, award is definitely organisation the maximum for an appreciation announced its 30 th annual INDIASTAR ever, that every company INDIASTAR Alukbliss was awarded related to packaging aspires for. award. Out the best product in We are proud of a total 507 packaging material that Alukbliss participants across and adjunct category. was selected as categories, the the best product maximum for in packaging INDIASTAR ever, Alukbliss was awarded material and adjunct category. the best product in packaging We would definitely strive towards coming material and adjunct category. more with innovative The call for nominations was up performed earlier this year. products like Alukbliss that With a jury consisting of would help the pharma eminent personalities such as industry as a whole to fight Kiran Prayagi, Printing drug counterfeiting as well as Consultant, Graphic Arts & have a unique brand identity,” Technology & Education; said Michael Franklin, CEO, N C Saha, Director-IIP & ACG Pharmapack.

Cognex introduces entry level vision system with autofocus and integrated lighting COGNEX Corporation, the world’s leading supplier of machine vision systems, has introduced the In-Sight® 7010, an entry level vision system developed specifically for inspection tasks where vision sensors are too limited and a standard vision system may not be cost effective. Every aspect of the In-Sight 7010 has been designed to make deploying a vision system easier than ever before. It is a completely self-contained vision system that includes autofocus optics and In-Sight 7010 integrated lighting in a compact IP67 rated industrial housing. Applications can be configured very quickly using the intuitive EasyBuilder® user interface. The vision library on the In-Sight 7010 has been simplified to

focus on the tools most frequently used in straightforward vision applications. “We are excited about the In-Sight 7010. We believe it will open up a new range of applications where vision systems can be applied,” said Bhaskar Banerjee, Business Unit Manager, Vision Systems. “The In-Sight 7010 can be taken right out of the box and put straight on the production line with minimum time, cost and effort.” The built-in autofocus capability of the In-Sight 7010 makes it ideal for production situations requiring regular part changes, or applications that require the vision system to be placed in hard-to-reach spaces where manual focus adjustment would be difficult.

Modern Pharma•16-30 Sept ember 2012

In Conversation With

For running a successful venture in an industry, one has to take care of the interest of all the stakeholders …shares Dr Rajesh Jain, Joint Managing Director, Panacea Biotec Ltd. Knowledgeable yet down to earth, busy yet punctual, humble with a smile on face is what defines him. In this conversation, he shares some snapshots from his life.

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

What does success mean to you? Success does not come only in the form of monetary gains. We have grown in people, profit and revenue over a period of time and in terms of infrastructure, markets, etc. But are we really successful? One can call themselves successful when they start addressing the interest of all the stakeholders including society. Today, we are talking about quality, affordability and innovation, which mean safer and better medicines. We are talking about access to medicines for all. Government is trying to ensure that the

We have developed the capability of working with the small start-up research companies and also large MNCs, including government companies.

drugs are affordable. Healthcare industry is unlikely to have similar return on investment as compared to that of IT and other industries. So, one has different stakeholders asking for different deliverables. For running a successful venture in an industry, one has to take care of the interest of all the stakeholders. Yes, we are a little far away from success but the good news is that we are sensitive to this and are working towards it. We will not like to see anyone picking up at the pharma & vaccine industry and saying that it was unethical and had overpriced products. We do not want to hear grievances from our customers on quality of our products. So, I believe that truly in terms of success, it is yet to happen. Personally, I feel I am not that successful yet and have a long way to go. Of course, I have grown in terms of experience, understanding and sensitivity. Down the years I have become more conscious of my actions. And I believe that one learns this primarily

from one’s family. They are the ones who come up and tell us where we have gone wrong. I have learnt a lot from my elder brother. He was always the biggest support and opposition as well. He has built the company and led the family. From him I have learnt to perform when the tides are against you; never ever lose heart and effort. After that, it is the simplicity of my younger brother, parents, my grandparents that has made me very humble. We respect everybody in the company; from a chauffeur to a highly qualified scientist in the lab. Another lesson that I learnt was the adoption of technology as fast as possible and do not try to do everything on your own. Just go out to the market; if one finds someone doing a good job try to get him in. Develop something unique for yourself where you can be invited by others. We have developed the capability of working with the small startup research companies and also large MNCs, including government companies. We started respecting the impatience of a small start-up company and also accepted the delays of bureaucracy in the government companies and large MNCs. This is the kind of balance that we have. This kind of understanding comes only when one faces failure. I have failed multiple times in my career of 20 years and have learnt a lot. There have been several setbacks. It has been a perfect roller coaster ride, although there has been growth phase as well. There is a huge need gap in the industry at the moment. How is Panacea Biotec taking care of this? There are a huge number of patents that will go off soon. But this is an opportunity that always existed since the last 20 years. India has come up as a large exporter of drugs, volume and price wise to the key markets ranging from the US to Europe. We are trying to address the generic market but it is ‘difficult to develop generics’ and that remains our focus. This mixes well with our internal capacity to innovate because to innovate refers to working differently. Thus, we need to deliver in a different manner. We are into developing nanoparticles, micro particles,

Photograph: Amit Kumar

microsomes. These are some difficult products that we are developing and they require technological strength and intellectual horsepower. How similar and dissimilar is Dr Rajesh Jain from Panacea? One of the comments that I have received from the CEO of an upcoming American company is whatever they see in me is what they saw in the company. I will not say that I am reflected in the company, but yes I reflect the whole Board. I am small part of the whole. Only when they said this I realised that an individual can reflect the company. What are the qualities that you look forward to in your colleagues? Integrity, humanity and innovation are the three qualities that I really appreciate. In addition, I like people to be sensitive. If one is not sensitive and not acting in responsible manner then I will never appreciate it. One needs to understand that one is doing a job pervaded with competition. Delivering quality and on time will be a challenge. What is important is to comprehend the potential implication of not meeting the quality standards and timelines and

The reasons for failure can be multiple, and they should be acknowledged and appreciated as long as we are learning from the mistakes.

How do you handle challenges in life? I stop thinking. That is the very first thing that I do. I will let things happen as they are. The moment you start analysing in a crisis situation too much then it gets problematic. Almost a ‘no mind’ status or a meditative state is what I prefer. But that does not mean I am cool and calm. ‘No mind’ means that I am seeing the truth and facts in its entirety, even if I am responsible for it. When the mind starts working we tend to find problems with others and feel that everyone is wrong except us.

what is important. Have you put up a mitigation plan that it does not reoccur? I would say that start anticipating those issues. Thus, make sure that whatever you learn is documented. It is not a problem if one fails, if one fails on the same issue again then it becomes a problem. The reasons for failure can be multiple, and they should be acknowledged and appreciated as long as we are learning from the mistakes. And it takes time to have this realisation. I was never like this 20 years ago.

What’s next for you? I am not thinking much in regard to what will happen to me in future. I want to contribute in a useful way step by step. I have strategic business plans for the company and I am very clear about them. But when it comes to personal terms, at some point I would want to do lot in education. That is my personal inclination. I would like to do a lot for the areas that are completely ignored as of now in India. Further, I am looking for contributing in energy-based endeavours.

then perform accordingly. We must remember that scoring a six on every ball is impossible as well. Expecting every batsman to score century is impossible. Losing wickets quickly for a team is a real-time scenario. When one encounters failure, in that situation, how sensitively one analyses the root causes is

Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

Special Focus

Cosmeceutical quality Shibani Shah shibani.shah@network18publishing.com

hybrid between pharmaceuticals and cosmetics, cosmeceutical are products with biologically active ingredients having druglike benefits. With changing lifestyle of the people, both men and women are caring about their skin more than ever before. Although women from generations have dedicated time for taking care of their skin, today major women are changing occupation from being just a home maker to being a full-time professional and hence does not have eonugh time to dedicate to conventional beauty treatments. Thus, the need for fast-acting skin care products aroused. The boom in cosmeceutical coincides with people’s ever increasing interest in natural and safe products. Himani Chandna, Group Product Manager, L’Oréal Active Cosmetics Division, says, “Cosmeceuticals is a hardcore category of products promising efficacy and are purposive in nature. The inclination of people to use cosmeceuticals comes from the kind of efficacy these products offer.” The skin care segment will account for 63 per cent of all cosmeceutical product demand through 2012 is expected to grow to $ 22.1 billion in worldwide sales by 2013.

Meeting demands vigilantly With the growing awareness in skin care among people, there is an increasing demand for quality products. Let us take a peek into the cosmeceutical trends expected in the future and the latest innovations in this sector.

Forecast for the Indian market

Indian demands The demand for products for a fair and beautiful skin no more restricts to the females. Even the males today in India are preferring beauty products to take that extra bit of care of themselves. Dr Soma Sarkar, Cosmetologist & Dermatologist & Influencer, Project Effexx Merck India Initiative, says, “The cosmeceutical market in India is growing by leaps and bounds. The number of patients we attend on a daily basis is testimony to the fact that the demand for pharmaceutical products coupled with cosmetic properties is on the rise.” The global market was initially focussed on the treatment of acne using retinoid and skin lightening agents such as hydroquinone but with there has been a shift to anti-ageing in the last decade and especially to the ones having natural antiageing actives. Chandna further adds, “It will not be a fair to compare the potency of synthetic cosmetics and natural sources. Both undergo years of research in their own way. But in the Indian context, we often see people inclined towards the conventional products from natural sources.” Dr Sarkar further adds, “Depending on the patient’s requirements, we recommend them products that are often available over the counter to cosmetically treat various skin

Dr Sarkar elaborates, “The latest innovations are called ‘nanoceuticals’ that mimic the body’s normal skin protection function. These are essentially nutrients that have been reduced to a nanoscale through a process called nanotechnology. In addition to this, there are specific molecules that have come up for specific ailments.” Nanoceuticals that were launched around the year 2009 entered every domain the nutrients sector like nutritional supplements, slimming shakes and skin care. There are years of research that goes into the making of these products since there is immense data that needs to be generated before making a claim on the safety or effects of these products. The biggest challenge faced here is the uniqueness of every user and developing the product suiting the needs of maximum skin types as possible.

ailments. These products contain actives with fitting properties that soothe the skin and offer care at the same time. With the increasing demand for these products, the number of pharmaceutical companies producing them has also increased.” Increasing awareness is the major reason that has caught the attention of Indians to these products. Chandna suggests that it is the involvement of medical practitioners that has made the people aware about such products.

claim of the company and the delivery of the claim in the product that matters the most to the consumer backed with the safety and efficacy of the product. The consumer is dependent on the medical practitioners and other influencers for the guidance to use the correct product. But at the end it is the consumer’s experience that gets

Growth drivers An ageing skin is something that everyone today is fearful about. Everyone wants to look young and beautiful forever. Anti-ageing products are said to drive the market in future. Sarkar explains, “The average age of Indians opting for skin care solutions has changed. Increasingly, people are realising that skin’s ageing process starts at the age of 22 years and it is important to pay attention to it while in its early stages. Anti-ageing is thus one of key drivers in our industry. Apart from this, a lot of patients also come to us for hair care and fine fairness consultation.” Chandna believes it is the

Addressing your skin care needs by opting for products and services that are derived from natural sources is always a safer option compared to chemically enhanced ones. Dr Soma Sarkar Cosmetologist & Dermatologist & Influencer, Project Effexx Merck India Initiative

them hooked to the product. Hence, the major reason that a particular product will sustain is the loyalty it shows in delivering the company’s claim.

Science behind With the growing awareness the people are opting for products derived from natural resources since they are safer to use as compared to the synthetic ones. Scientists and researchers have discovered the role of dietary components, phytoactives and food ingredients in supporting beauty from within in the form of nuticosmetics and cosmeceuticals for topical applications. Dr Sarkar suggests, “Addressing your skin care needs by opting for products and services that are derived from natural sources is always a safer option compared to chemically enhanced ones. They are completely biodegradable and mimic the same chemical components as a regular product.” Natural antioxidants that quench free radicals are the essential component of the anti ageing formulations. Natural peptides are innovative cosmetic ingredients that can be potentially used to counteract wrinkles formation and loss of elasticity.

The Indian market has more to expand in terms of cosmeceuticals. The feeling of being beautiful has a psychological impact on the minds of the people that boost a sense confidence among them. The changing definition of being beautiful and external appearance making a big impression are also factors affecting the market. In the Indian culture, for ages there have been conventional innovations to have a healthy beautiful skin. With the rise of cosmeceuticals these conventional methods have been replaced by new fast fix methods. Dr Sarkar adds, “Indians today are conscious about the way they look. With the average disposable income of Indians increasing, they do not restrict themselves from spending on their skin care needs. More often than not, beauty and beautiful skin is a confidence booster for people. It is because of these reasons that more and more people from metros and mini metros in India opt for such solutions. In the years to come, this industry will see a further surge in demand.” Chandna adds, “The industry is growing exponentially and the evolution of the industry will be rapid and the growth is expected between 40-50 per cent.” With the innovations and new product launches and increasing demand among the people this sector is bound to face a tremendous growth. But to sum it all up its product’s quality that will speak for it and define the success. India is still to explore a lot and a huge market is available for cosmeceutical in the developing countries and the developed ones too.

Modern Pharma•16-30 Sept ember 2012

Special Focus

Cosmeceutical trials in India Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

ccording to a report of Freedonia, the US demands for cosmeceutical products is expected to increase 5.8 per cent annually through 2015. Injectables and skin care products will see the fastest growth. Among chemicals, antioxidants will remain the largest category, while botanicals will continue to see the fastest gains. With time, consumers are becoming more aware about the science behind cosmeceutical products. Their interest primarily stems from the fact that almost all of these products are manufactured from natural resources. They are aware that these products have exceptional quality in them. And hence, the requirement of cosmeceutical trials in this regard. Today, most of us are apprehensive to use any product that does not provide clinical study efficacy or safety data. According to the reports of RNCOS, India has emerged as one of the industries having huge potential for further growth. It rates the Indian cosmetic industry as one of the rapidly growing industries. Due to the changing lifestyle and spreading consumer awareness, people have become more beauty conscious. The report shows that Indian cosmetic market growth is accredited to female consumers; however, the mind set of male consumers is also changing primarily due to the increasing influence of media and Western exposure. The fast emerging men’s grooming products market has also boosted the cosmetic sector. In addition, urban areas contribute the maximum to the overall cosmetic revenue; however, the rural region still holds a huge potential for players. The key factor

Cosmeceuticals with herbal inputs and actives of natural components are medicinally useful and do not have side effects at all. Jignesh Shah Proprietor, Radiance Cosmeceuticals,

Scanning the growth opportunities With disposable income and awareness levels increasing, modern people conscious of their looks are opting for cosmeceuticals. It is almost a prerogative to conduct trials and check the safety factor of these products. Here, we analyse cosmeceutical trials.

also, which are separately promoted by the companies.” According to him segments such as skin sensitivity, hair care, SPF evaluations, oral products have huge clinical trial demands. He highlights, “Different sponsors look out for different outsourcing models, namely full service to individual services such as protocol development, essential document development, clinical trial management & site management, product testing and manuscript writing.”

Going forward

for future growth in the rural region will be low price and high quality products with easily accessible supply chain networks.

Safety factor All of us prefer to use products from companies known to conduct clinical studies on finished formulations. And therefore, proof of this efficacy of ingredients is extremely vital as several consumers have varied choices. Thus, in this context, comprehensive animal and human clinical evaluation studies are must in order to determine safety and efficacy for the development of cosmeceuticals. Elaborating on the need of cosmeceutical trials, Jignesh Shah, Proprietor, Radiance Cosmeceuticals, avers, “In India, cosmeceuticals has a huge market. It may be possible that cosmetics with synthetic components have side effects. But cosmeceuticals with herbal inputs and actives of natural components are medicinally useful and do not have side effects at all. In other words, these products are made from natural resources such as aloe vera, almond oil, natural proteins, olives, shea butter, jojoba beads, etc. So it is feasible to conduct cosmeceutical trials for human safely.” According to him these products have wide variety. They vary from soap to oil and many others depending on end use utility. They are also available in form of different physical forms like cakes, gels, lotions, creams etc. Discussing the cosmeceutical trial scenario in India, Kunal Bhatt,

Global Manager, Business Development & Projects, Vedic Lifesciences Pvt Ltd,

Comprehensive animal and human clinical evaluation studies are must in order to determine safety and efficacy for the development of cosmeceuticals. elaborates, “Cosmeceuticals is a combination of cosmetic and pharmaceutical product is looking at a Compounded Annual Growth Rate (CAGR) of 17 per cent during the period of 2011 – 2015 in India. There is an increase in demand and awareness in the consumers for innovative and quality products. In parallel to this, the regulators also have started looking into the nuances of this industry and this has compelled the companies to release more and more clinically tested products into the markets. This has led to an increase in the number of clinical trials being done for cosmetic products in India.”

Market drivers There are several factors contributing to the growth of the market. Talking about the growth drivers for the market, Dr Navneet Sonawane, Senior Manager - Clinical Operations, Vedic Lifesciences Pvt Ltd, shares, “Increase in emergence of several companies

manufacturing cosmeceutical products, preference to use clinically tested products as against products that do not have any safety or efficacy data are few of the growth drivers for the cosmeceutical trial industry in India. Further, the increase in disposable income, fashion consciousness has also been growth factors for this industry in India.” Talking about business opportunities, Bhatt opines, “Skin care, hair care, oral hygiene, baby care products and body odour are most popular product segments. Recent trends show an increase in the demand for specialised products for men

Extensive research resulting in more and more clinically tested products in the markets would lead to tremendous growth of this segment. Dr Navneet Sonawane Senior Manager - Clinical Operations, Vedic Lifesciences Pvt Ltd

In spite of the intense growth market prospects, there are several challenges in the way. Talking about the obstacles, Dr Sonawane says, “Availability of good sites with good infrastructure and instrumentation, trained technicians and the mindset of companies allocating fewer funds for cosmeceutical trials are few of the challenges.” She continues that the Indian regulations still need to be evolved in India as compared to the other markets. She highlights, “Cost of conducting such trials with high quality data, ethics and medical expertise remain the main factors for cosmeceutical companies to come to India for conducting clinical trials.” Talking about the market scope, Bhatt says that the current markets, which are mainly dominated by skin and hair products account for nearly ` 25 billion. Currently the industry is driven by powerful demand in rural and semiurban areas. Discussing the future path, Dr Sonawane says, “Extensive research resulting in more and more clinically tested products in the markets would lead to tremendous growth of this segment. Factors such as regulations, fund allocation and general awareness for clinically tested products are the major factors that would decide the future of this industry. A huge population of more than 560 million among the target age group of 18-35 years makes India one of the most preferred destinations for cosmeceuticals. Also, it is estimated that the Indian cosmeceutical industry would be worth ` 20,000 crore by 2014.” Interestingly, today various companies have started opting for online retailing and are offering specialised products in order to generate revenue from all the corners. And rising usage of cosmeceuticals and nutricosmetics by the Indian consumers will also pave way for the Indian cosmetic market during the forecast period.

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Special Focus: Interface

Brand protection is important for all industries including pharmaceuticals …says Siddhartha Sengupta, Head - Pigments, Performance and Life Sciences Chemicals, Merck India. Here, he talks about the cosmetic industry, Project EffexX and brand protection for pharma products.

Shibani Shah shibani.shah@network18publishing.com

Can you compare the global and Indian cosmeceutical market? The cosmetic industry is growing at 17 per cent CAGR and is expected to grow at the same rate for the next five years. India has a very low per capita usage of cosmetic products as compared to other countries. Hong Kong, Taiwan, Thailand and Korea are almost 15-40 per cent of India. Although the consumption of certain cosmetics is less, products such as talc powders, which have a huge market in India, are merely present on the global scale. What has caused the sudden boom of cosmetic market in India? The economy of the country has played a crucial role in this sudden boom of the sector. The spending power of individuals has gradually increased. Previously, only the cream layer of the society could afford these products and with time they prefer imported and international quality products. The growth in terms of buyers is actually coming from the middle-class layer of the society. People who could not afford cosmetics in the past like the lower middle class and teenagers are now going in for cosmetics that are manufactured in India or smaller multinationals; these products are affordable in their range, however, gradually even they are moving to a higher range. The trend observed is very similar to the West. The difference is only in the timeline. What happened in Western countries 20-30 years ago, is happening today in India. Nowadays, even in villages you will see a lot of cosmetics brands. Marketing strategy has also played an important role with top brands being available in cost-effective packaging. Women are still taking care of their skin and will continue to but now with changing lifestyle they are looking out for quick fix options in place of timeconsuming conventional ones. What are the key growth drivers and foreseeable trends of the cosmetic market?

Among the growth drivers are personal care and skin care products, and anti-ageing products. Fairness products have always been an important part of the cosmetic market and hydration is currently growing. The colour cosmetic market is also gradually gaining pace. Anti-ageing products are expected to be the number one grosser of the future. Fairness products are a huge part of Indian market and will continue to be a big contributor. Skin care, that is already a big market in the West, is expected to escalate further in the next five years. Today, pigments are being used widely, however, the cosmetic market is going to be dominated by actives in the next three years. Can you tell us about actives used in cosmeceuticals? Dermocosmetics or cosmeceuticals are specific products applied to prevent and treat skin diseases and therefore they not only need to meet the general legal regulations regarding cosmetic products but furthermore comply with further scientific stipulations. Cosmeceuticals are mainly based on their active ingredient functions and the claims correlating to the properties of the active ingredients. There are a variety of active ingredients used in cosmeceuticals, to prevent and

We want the consumers in India to ask for a better product and ask what goes into making of the product to make a better choice. treat specific skin ailments ranging from diabetic skin, psoriasis, rosacea, etc. Describe actives developed from natural sources used in cosmetics. There are many actives that are developed from natural sources and used in cosmetics. Actives that are a derivative of plant derived rutin that is very useful against skin irritation. Then there is also a product derived from the epidermal hair of plants and has effective anti-ageing properties for sensitive skin. Another example of active from natural sources would be

an extraction and purification from the plant Dimorphandra mollis that is effective against cellulite and is used against disturbed blood circulation and venous disease. Another key active we develop is derived from the fruit extract of Phylanthallus emblica that is a powerful anti-oxidant for skin and a skin lightener. Another example would be an active that we derive from microbiological origin from halophillic bacteria that gives a complete cell protection and long term power moisturisation and is useful against skin ageing processes and external stress like heat, UV radiation, dryness. Tell us more about Project EffexX. Through Project EffexX we want to empower people and educate them about what goes into the making of the products they use. The stake holders are the primary consumers but the key part is played by ‘influencers’ such as hair stylists, spas, dermatologists, packaging designers who recommend people about the type of products they should use. We want to get them on this website, discuss talk and educate them about the products that they

recommend. We want to create an awareness, first among influencers and finally end consumers. We want the consumers in India to ask for a better product and ask what goes into making of the product to make a better choice. It is high time that India should get a better range of products. Finally, we are also trying to graduate our customers to a certain level. A lot of customers now want to go global so they want to develop an export level product, and hence, we want to provide them with a platform wherein they can fulfill this. We help them with our labs, technical knowhow, legal procedures and finally marketing strategies and ideas but we do not financially assist them in any way. You have an idea—it could be a really big idea for a new product or even a small simple idea that one would need help with in order to transform it into reality. There is a simple way around the problem ‘co-creation.’ That is what we call the process of finding a partner and creating something together. Here, with Project EffexX we will lend them support to help make their dreams come true.

How can pigments be of benefit to pharma manufacturers in terms of creating a brand protection? Today, brand protection is important for all industries including pharmaceuticals, electronics and luxury goods. With the increasing number of counterfeit products in the market, brand companies should not ignore this aspect, which could affect their overall goodwill and thereby sales of the company. Counterfeiting not only affects company sales; also at stake are consumer trust and brand reputation. Brand protection is critical, especially for pharmaceutical manufacturers, since their products have a direct impact on consumers’ health. We use special pigments that change colour, enabling the consumer to see visual effects without the use of any verification device and distinguish between real and fake products. Covert solutions are usually created for brand owners to identify their original product and are recognisable only through technical means. Brand owners could opt for overt solutions alone or even club them with covert solutions for complete brand protection.

Fa hav imp cosm hydr gro cosm gradu

M o dern Pharma•16-30 Sept ember 2012

Insight & Outlook: Policies & Regulations

FDI in pharma Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

ast year, the Indian Prime Minister chaired a high level meeting in order to discuss the Foreign Direct Investment (FDI) policy pertaining to drugs and pharma sector. The meeting was attended by Pranab Mukherji, then Finance Minister; Ghulam Nabi Azad, Health Minister; Anand Sharma, Commerce, Industry and Textile Minister; MK Alagiri, Chemical and Fertilisers; Dr Montek Singh Ahulwalia, Deputy Chairman, Planning Commission. Among other discussions the meeting primarily deliberated upon the Maira Committee report, which followed a Cabinet Committee on Economic Affairs (CCEA) decision in order to get greater clarity on the issue of FDI policy governing M&As in the pharma sector, while maintaining a balance between larger public health concerns and strengthening domestic manufacturing capacities. The meeting considered the following decisions: India will continue to allow FDI without any limits (100 per cent) under the automatic route for Greenfield investments in the pharma sector. It was believed that this will facilitate addition of manufacturing capacities, technology acquisition and development. In case of Brownfield investments in the pharma sector, FDI will be allowed through the Foreign Investment Board (FIPB) approval route for a period of up to 6 months. During this period, necessary enabling regulations will be put in place by the Competition Commission of India (CCI) for effective oversight on M&As in order to ensure that there is a balance between public health concerns and attracting FDI in the pharma sector. Thereafter, the requisite oversight will be done by the CCI entirely in accordance with the competition laws of the country.

The brighter end

The health ministry was concerned that large scale takeover of Indian pharma companies by MNCs would deprive Indians the availability of cheap drugs. Therefore, according to the new framework, the FIPB’s prior clearance became a mandate for any FDI in an existing pharma company. Further, after 6 months, foreign investment deals in existing pharma

Understanding the criticality While some industry experts assert that Foreign Direct Investment (FDI) in pharma will help in endorsing India as the global pharmacy hub, some believe it is quite the reverse. They state that FDI will ultimately increase the price of the drugs. Read on to analyse the pros and cons of FDI in pharma. Gupta, Founder and Managing Partner, IvyCap Ventures Advisors Pvt Ltd, reiterates, “Every policy has its own plusses and minuses. FDI gives an exposure to not only the financial investors but also to the strategic investors. The main issue arises when they feel that the FDI may work against the patients’ affordability in India.”

The not-so bright end

companies were required to get a ‘yes’ from CCI. In addition, concerned ministries had to put in place necessary regulatory framework. However, the DIPP

With time, India is becoming a global pharmacy hub and in this regard FDI in pharma is definitely a positive step forward. Dr H G Koshia Commissioner, Food & Drugs Control Administration

is insisting on continuing with the stop-gap arrangement of FIPB functioning as the approving authority. The DEA, headed by the Prime Minister now, wants to go by what was decided by him nine months back. Discussing the FDI in pharma, Dr H G Koshia, Commissioner, Food & Drugs Control Administration, avers, “Several companies are keen to invest in India. There are several MNCs and Indians that are collaborating. With time, India is becoming a global pharmacy hub and in this regard FDI in pharma is definitely a positive step forward. India is the only place that can provide affordable drugs.” Elaborating on the recent development, Dr Koshia adds that in Gujarat P&G and Teva have joined in order to establish a facility of approximately ` 500 crore. Thus, FDI is a welcome move for the Indian companies. According to Dr Koshia there is practically no challenge as far as the FDI in pharma is concerned. He highlights, “In fact, the FDIs will open various

new job opportunities. Indian companies are famous for their manpower.” Talking about the positives of FDI in pharma, Vikram

Every policy has its own plusses and minuses. FDI gives an exposure to not only the financial investors but also to the strategic investors. Vikram Gupta Founder and Managing Partner, IvyCap Ventures Advisors Pvt Ltd

The recent acquisition of Indian generic drug companies by the MNCs has raised serious concerns that it will ultimately push up the prices of essential drugs. Further, the Union health ministry’s internal assessment suggests that the recent buy-offs will also diminish the domestic availability of several essential medicines that were earlier manufactured and sold by the acquired firms. Talking on the flip side of the FDI in pharma, Gupta avers, “While having discussions on FDI it must be remembered that an acquisition price should not be reflected on the price of the products only. The acquisition price is fixed based on the long term picture in mind. Gupta mentions, “While financial investors have short-term purposes in mind, the strategic investors are looking for the long-term plans. Thus, what is required is government intervention. Government needs to review each and every case in this context. He reiterates, “Thus, it is not about fixing the restriction on the percentage but on the approval.” He explains that the government needs to find out which of the cases are real and therefore needs immediate action. Identifying the right company and the purpose is of prior importance. He reiterates, “Today, the issue on FDI in pharma has assumed the role of political mandate. And in this situation what is important is to see how the pharma companies are able to drive it.” The future of the issue primarily depends on how much debate is it able to generate. It is important for the mass population to react to this. Thus, it is not the decision on what is the limit that is important, but the identification of the purpose is critical.

Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

18 Insight & Outlook: Strategy

‘Catching’ young doctors

Hit hard, hit early!

Discussed below are some areas that provide a window of opportunity to the pharmaceutical industry to make an indelible impression on the minds of interns in medical colleges across the country. These companies can impress interns by replicating the maxim used for prescribing the anti-AIDS therapy: Hit hard, hit early!

he final MBBS results were just out and a small notice pasted alongside in Lokmanya Tilak Municipal Medical College, Mumbai read: “Congratulations, doctors! All students who have passed Final MBBS exams held in October 1985 are requested to assemble in Physiology lecture hall at 10 am on Thursday (date) for instructions on their internship program.” The day arrived and most of us got ready early, due to admonition by our parents to start dressing and behaving like doctors, at least now! The Dean arrived on the dot of 10 am and congratulated us on our achievement. After a brief lecture on the year-long compulsory rotating internship programme, he wound up. Before allowing us to disperse, he told us to hold on for a few minutes as a pharmaceutical company would like to present a token gift! Two smartly dressed young men entered the hall with a couple of cartons which they unpacked. They unloaded and distributed packets which looked like lunch boxes on which were the words: “Welcome to the world of medical practice! This is a small introduction to the products of …. Pharmaceutical Company.” All of us eagerly opened our boxes as we left the hall to find a bar of chocolate neatly placed among a few emergency injection vials, syringe and needle, some tablets, a roll of bandage and a Band Aid. It did not take us long to understand the gravity of the situation that we had all become responsible physicians and society was going to look at us differently, henceforth. This was a young doctor’s first official encounter with a drug manufacturer. The company had managed to make an unforgettable mark on his grey cells and the medicines placed in the box would be remembered forever. When he gets a chance to write the next prescription there is very little chance that one of these brands would be forgotten. With a small bar of chocolate, the company had secured a prescribing partner for life! Like in the preceding years, 80 per cent of the batch completed internship and took up specialisation in various fields of medicine, while the others decided to study abroad or set up their general practice clinics. The rest of the physicians’ lives were spent building up their career, renting out or purchasing clinic premises, developing practice, learning to interact with patients

and their families. Just like the people in other fields, many mistakes were made and some young doctors learned from them and improved. Others did not realise that they needed to be more proactive, empathetic and appear involved with the patients to improve their practice.

Speed breaker ahead!

For the young doctor entering post-graduation, the hospital corridors cocooned them from the rigours of private practice, for some years at least. For the others, the battle had just begun. Not many of the young doctors had wealthy parents who had already purchased premises for their clinics. Those who were not financially resourceful took up jobs as government medical officers/casualty officers to accumulate funds in order to set up their clinics. Most middle class doctors had to purchase clinics on loan. It would take some time for the young doctor to learn that different categories of loans are available and that they have different rates of interest and repayment schedules. On paper, bank loans were ‘easily’ available to doctors, but the procedure was cumbersome, unless there was an ‘uncle’ working there! How much loan is a beginner eligible for? How was one to prepare a cash-flow statement for the next 10 years (period of repayment) even before setting up one’s clinic? These are issues, which the young man or woman

appears to be lost in. They wish that their medical college trained them in setting up their private practice as well. When the first patients visit them, they innocently prescribe the appropriate drugs. However, the accompanying instructions about the nature of the disease, the do’s and don’ts and the method of preventing a recurrence are forgotten. It takes him/her a while to understand that prescribing drugs is not what brings the patient back to the doctor, it is the explanation and empathy that he shows that helps to forge a permanent bond. The intensity of the relationship alone will ensure that his name is recommended to the patient’s friends and relatives. Where to refer the patient for tests and for speciality opinions is another area of difficulty for the new physician. Unless he already has a colleague or a senior practising in the vicinity, they find it difficult to refer patients to a trusted expert. With the current unethical atmosphere, there is a constant fear lurking in the minds of the doctor that his patient should not reach the wrong specialist.

Pharmaceutical opportunity

There is an old adage: every problem is an opportunity. While the interns in this story had a company welcoming them into the profession with a first-aid kit, they lost a massive marketing opportunity. They could have involved the fresh

interns further by addressing their future requirements. However, in those days it was enough for the manufacturer to be remembered by the company; the prescriptions flowed! Today, with the plethora of drug manufacturers and the wide basket of products, the physician finds it difficult to remember brands.

Addressing interns’ needs

During the phase of internship, while the newly ‘graduated’ doctor gets to personally handle needles, knives and diagnostic machines under the supervision of seniors, he is also trying to gauge where his future lies? Seniors guide them to some extent but there is no systematic attempt to understand how they should go about shaping their future. Drug manufacturers can fill in some of these gaps by counselling them with the aid of experts. Currently, pharma companies simply detail products and give diaries, books, pens and other minor complimentaries to interns when the MR visits medical college hospitals on rounds. The main focus of their attention is on the heads of departments and senior physicians who make the major decision on prescription trends in their department. It would be worthwhile to direct some energy at the interns, some of whom may turn out to be future top prescribers of these brands.

Group talks

Groups of interns could be

gathered for small sessions on their future needs. Bringing in specialists and speakers can think from the interns’ point of view will attract the latter to attend such talks. Experts from the banking industry can address them on financial aspects of setting up a clinic or a diagnostic centre. Full-time professors can be invited to speak on a career in teaching. India has an acute shortage of qualified medical teachers. With the revised 6th Central Pay Commission recommendation of UGC scales, a teaching career today is far more lucrative than they paltry ` 4,500 it used to be two decades ago. Government regulations on setting up a hospital in cities such as Mumbai have undergone major transformation in recent years. Current laws make it compulsory to have a separate entrance and water connection for a nursing home. In the past, a nursing home could be started in any residential/commercial premises without the need for any registration. In March 2011, the building proposal department of the BMC sent notices to about 756 out of the total 1,400 nursing homes to change their user type. Today, it can only be run in designated premises with ‘change of user’ certification from the Municipal Corporation and it has to be registered with the Bombay Nursing Homes Association. Architects and legal experts could touch upon these technical aspects to young physicians who can then plan their future easily. Although the income of an intern is in the nature of stipend, issues pertaining to income tax are poorly understood by them. Deductions in taxes for joining a medical association or purchasing books or clinical gadgets can be claimed only if the receipts are properly submitted and appropriate bank entries shown. Proper training by Chartered Accountants can help these young doctors save more of their hard-earned money. While the investment on this exercise will not reap immediate dividends, it could begin a long, happy association between the young doctor and the company. With so many private medical colleges running, they too would be willing to offer their space even if the sessions are conducted at a nominal charge. Dr Rajan T D Pharma Consultant & Practising Dermatologist rajantd@gmail.com

Modern Pharma•16-30 Sept ember 2012

Insight & Outlook: Interface

The challenge will be to encourage putting in place the right policies that will facilitate the growth of biotech industry phase of a biotech product’s development. In India, there is tremendous opportunity for vaccines development, as well as innovative R&D for stem cells and regenerative medicine. BIO’s member companies are interested in collaborating with India’s scientists to push the boundaries of science and translate that science into new biotech products. BIO companies are also seeking partners to manufacture and distribute biotech products in markets like India and around the world.

sector, it is a critical time to capitalise on the biotech opportunities available within India. Arshia Khan arshia.khan@network18publishing.com

Healthcare is becoming a political agenda worldwide. Your views In the US, a lot of attention is being devoted to healthcare right now as our industry strives to create a policy environment that supports and encourages innovation and, ultimately, enables the industry to deliver cures and treatments to patients. With healthcare a top political priority, this gives way to proving the many benefits the industry has to offer in terms of advancements and breakthroughs. Biotechnology is improving the odds for millions of patients around the world with serious, life-threatening conditions. In the US, a lot of attention is being devoted to healthcare right now as our industry strives to create a policy environment that supports and encourages innovation. This ultimately enables the industry to deliver treatments to patients. Similar to the US, India has a burgeoning biotech sector, and the Indian government has invested billions into biotech research. India’s biotech and pharmaceutical space is world class, and the number and type of collaborations between Indian and US or EU companies has grown rapidly in the past few years. During this period of tremendous growth in both the Indian economy and its healthcare

What are the pain points of the Indian biotech industry? India has been viewed by many to be a promising location for biomedical product development and conducting clinical trials for foreign US and European investors and companies. However, policies such as compulsory licensing make India less hospitable for investment and collaboration. No company will, in the long term, view investment in a country where patents can be easily swept aside by a compulsory license, as being worthwhile. This is particularly the case when other countries in the region have a more Intellectual Property (IP) friendly environment. The industry cannot sustainably invest the tens of billions of dollars in R&D if there is no assurance of a return on that investment. As such India’s investment into biotechnology will be severely hindered. What trends have you witnessed in the US biotech industry that have paved way for newer avenues globally? The increasing interest in partnering opportunities from biotech companies has spurred interest in looking for partnership opportunities outside the US as well. Cross border collaborations can serve to boost the industry within India, as well as grow the global biotechnology industry. During this period of tremendous growth in both

…says James C Greenwood, President & CEO, Biotechnology Industry Organization (BIO). Here, he talks about the importance of a wellframed policy framework to fuel the growth of the industry. the Indian economy and its healthcare sector, many US companies are actively seeking new partnership opportunities in India. Which markets are promising for new product development industry? Within the biotech ecosystem, emerging markets play an integral role in each

What challenges would you forecast for the global biotech industry? As emerging markets become increasingly competitive in attracting biotech business development within their borders, we will begin to see expanded opportunities open up around the world to fulfill the true potential of this industry. The challenge will be to encourage putting in place the right policies that will facilitate this growth. BIO believes that public policies can promote innovation, collaboration and investment in the biotech sector, particularly strong IP protections and data protection as well as patent enforcement. A strong tax and regulatory mechanisms is likewise critical for encouraging growth of the industry, in any country. In addition, the anticipated global growth in population creates challenges and opportunities for the biotech industry, as biotech holds promising solutions to heal, fuel and feed the world.

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Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

Insight & Outlook: Indian Ayurveda market

Back to the roots

Landscaping OTC opportunities As the understanding of diseases becomes deeper, knowledge of ‘body as a holistic system’ and synchronised functioning among various organs are being acknowledged, especially in case of chronic illness. This has lead to the concept of ‘functional medicine’ –which identifies imbalances and dysfunctions in the body – the underlying causes of diseases - specific to the individual. In a way, it also qualifies as ‘personalised medicine’.

he perception of health and approaches to healthcare is undergoing a paradigm shift in many aspects and at many levels – be it practitioners, healthcare companies or consumers. The concept of personalised medicine is not new to traditional systems of medicine such as Ayurveda, which is known for treating the root cause of the disease by restoring erratic body functions. Hence, consumers are turning ‘back to the roots’ in search of ‘holistic health and wellness’. Though majority of the patients consume allopathic drugs as their primary treatment, Ayurvedic therapies do fall in their consideration as an alternative line of treatment. In the context of this renewed interest, CubeX recently published a report titled ‘Back to the Roots – Landscaping OTC Opportunities in the Indian Ayurveda Market’. This report explores various aspects such as global traditional medicines market, company profiles of key players in the Indian Ayurveda market, case studies of successful Ayurvedic brands and potential opportunities for brand building and business expansion. Some of the interesting highlights of the

Future potential of the Indian Ayurveda market

report have been covered in this article.

Leveraging opportunities in the alternative medicines market

Around the world, alternate therapies are being welcomed by consumers. The trend is reversing as West apes East

Figure 1: Contribution of major categories to Indian OTC market and Indian OTC Ayurvedic market 16% 20%

18%

Total OTC Market: $ 2063 million

15%

Ayurveda OTC Market: US $ 540mn

26%

12%

18%

31%

15%

3% Vitamins, Minerals & Supplements (VMS) Cough, Cold & Allergy (CCA) Dermatologicals (Derma)

Gastrointestinals (GI) Analgesics Lifestyle OTCs

Source: Nicholas Hall DB6 2012 database (India)

Figure 2: Contribution of Ayurvedic and allopathic products to Indian OTC market Lifestyle OTCs

Vitamins Minerals

96 15

Dermatologicals

Cough, Cold & Allergy

Ayurveda

Gastrointestinals Analgesics

Allopathy

45 0%

20%

55 40%

60%

% of OTC sales Source: Nicholas Hall DB6 2012 database (India)

in the gastrointestinal category also follow a similar strategy, competing with their allopathic counterparts. An interesting point to note is that in the Ayurveda market, almost each company has followed a different strategy of its own and yet gained success. On one hand, Amrutanjan has built a distinct identity in the analgesics market alone, despite being a one brand wonder. Dabur distinctly uses the company name to brand its products. Dabur Chyawanprash and Dabur Hajmola are its main pillars of strength. On the other hand, companies like Emami and Himalaya have a wide portfolio of Ayurvedic products, spread across major OTC categories. Himalaya Herbal Healthcare has a range of ‘pure herbs’ to cater to the need for natural products among consumers.

80%

100%

in terms of health patterns. Traditional Chinese Medicine (TCM) dominates the global alternative medicines valued over $ 100 billion with 85 per cent market share. Locally, TCM accounts for approximately one-fifth of the entire Chinese pharmaceutical market. Not to mention the dwindling pipeline of new drugs, hitherto wary MNCs have used TCM as a strategic moveto tie-up with local companies to enhance their presence the Chinese market. In 2001, Novartis announced collaboration with Shanghai Institute of MateriaMedica (SIMM) for drug discovery based on natural products. Boehringer Ingelheim bought the remaining 40 per cent share in Japan’s SSP (a producer of over-the-counter drugs) in 2010 and now markets Kampo medicines in Japan. On the home turf, few MNCs have explored the Ayurveda market, despite recognition of Ayurveda as a traditional system of medicine by WHO and favourable regulatory policies for Ayurvedic products. Few companies such as GSKCH and P&G have leveraged the opportunity for wide distribution through herbal renaming of ingredients in ENO and Vicks, respectively, and registered them as Ayurvedic products in India. GSKCH also launched a herbal variant ENO Pudina (Mint) to counteract competition from Dabur’s Pudin Hara G.

Distribution within

Indian Over The Counter (OTC) market has been valued at approximately $ 2 billion per Nicholas Hall DB6 2012 database (India), in which Ayurvedabased OTC products contributed more than a quarter to the total sales. The top five brands in Indian OTC market - Dabur Chyawanprash, BoroPlus, Vicks Vaporub, Revital and Zandu Balm - are either Ayurvedic in nature or contain herbal ingredients and this has been the USP of these brands. Gastrointestinals and analgesics categories contributed the highest (26 per cent) to the OTC Ayurvedic market. These two categories also stand out in terms of highest component of Ayurveda in the total OTC sales of the respective category. Analgesics Ayurvedic market is comprised only of topical analgesics. Ayurvedic formulations contributed over 70 per cent to the total OTC sales of topical analgesics. In fact, the top brands in the topical analgesics market (Zandu Balm, Moov and Amrutanjan) are Ayurvedic in nature, competing closely with diclofenac brands like Volini. Recently, VoliniActiv, an Ayurvedic variant of Volini, was also launched. While diclofenac Volini has been trusted and recommended by doctors, VoliniActiv will cater to consumers who believe strongly in Ayurveda. Traditional digestive remedies

Opportunities are immense in the Indian Ayurveda market. There is a need for quality products from reputed companies which offer trustand benefits of Ayurveda in convenient on-the-go formats. Many sub-categories like anti-nauseants, antidiarrhoeals, anti-allergy, scalp treatment, anti-fungal are yet to be explored. In case of chronic illness, Ayurveda can play the role of collaborative care. Even in the lifestyle OTC space like smoking control and female reproductive health, Ayurvedic products have a huge scope, as there are no natural OTC products available so far. Compliance of these lifestyle therapies is a challenge and offering a natural therapy may just prove to be a plus point to generate interest among consumers. There are many brands like Karvol, KayamChurna, Rhumasyl, which have the potential to soar much higher through brand building, as they are well-penetrated in certain markets. The attractiveness of Ayurveda and its holistic approach to health can be aptly summed by a quote from Deepak Chopra, MD, world-renowned mind-body healing pioneer. “The first question an Ayurvedic physician asks is not ‘What disease does my patient have?’ but ‘Who is my patient?’ By ‘who,’ the physician does not mean your name, but how you are constituted.” Sreedevi Yallamrazu Senior Strategic Analyst, CubeX syallamrazu@cubex.co.in

Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

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. Manufacturing of crofelemer Project type: Manufacturing Project news: Glenmark Pharmaceuticals Ltd is planning to set up a new pharmaceuticals project at Aurangabad in Maharashtra. The project involves manufacturing of Crofelemer. Project location: Aurangabad, Maharashtra Project cost: NA Implementation stage: Planning Contact details: Glenmark Pharmaceuticals Ltd Glenmark House, B D S Marg, Andheri (E), Mumbai – 400099 Tel : +91 22 4018 9999 Fax : +91 22 4018 9990

Manufacturing of dextrometorphan hydrobromide quinidinesulfate tablets Project type: Manufacturing Project news: Watson Pharma Pvt Ltd is planning to set up a new pharmaceuticals project at South Goa in Goa. The project involves manufacturing of dextrometorphan hydrobromide quinidinesulfate tablets. Project location: South Goa Project cost: NA Implementation stage: Planning

Manufacturing of digene gel Project type: Manufacturing Project news: Abbott India Ltd is planning to set up a new pharmaceuticals project at North Goa in Goa.

Contact details: Watson Pharma Ltd 301, Corporate Enclave, B D Sawant Marg, Chakala, Andheri East, Mumbai – 400099 Tel: +91-22-66886700 Email: corporate.hr@ watsonpharm.co.in

Project location: North Goa Project cost: NA Implementation stage: Planning Contact details: Abbott India Ltd 3-4 Corporate Park, Sion-Trombay Road, Chembur Mumbai - 400 071 Tel: +91 22 67978888 Fax:+91 22 67978920 Email: webmaster@abbott.co.in

Manufacturing of probioticsmicroorganisms/probiotic formulations Project type: Manufacturing Project news: Unique Biotech Ltd is planning

to set up a new pharmaceuticals project at Rangareddy in Andhra Pradesh. Project location: Rangareddy, Andhra Pradesh Project cost: NA Implementation stage: Planning Contact details: Unique Biotech Ltd Alexandria Knowledge Park, Genome Valley, Shameer pet, Hyderabad – 500078 Andhra Pradesh Tel: 040 23480 346/47 Fax: 040 23751 345 E-mail : info@uniquebiotech.com Manufacturing of tazarotene Project type: Manufacturing Project news: Watson Pharma Pvt Ltd is planning to set up a new pharmaceuticals project at Thane in Maharashtra. The project involves manufacturing of Tazarotene. Project location: Thane, Maharashtra Project cost: NA Implementation stage: Planning

Contact details: Watson Pharma Ltd 301, Corporate Enclave, B D Sawant Marg, Chakala, Andheri East, Mumbai – 400099 Tel: +91-22-66886700 Email: corporate.hr@ watsonpharm.co.in Veterinary drug residue laboratory Project type: New facility Project news: To establish a laboratory complying with international standards for surveillance of veterinary drug residues and prohibited substances in food of animal origin. Project location: Bangladesh Project cost: NA Implementation stage: Ongoing Contact details: Bangladesh Atomic Energy Commission (BAEC) Paramanu Bhaban E-12/A, Agargaon, Sher-e-Bangla Nagar, Dhaka- 1207 Tel : 880-2-813046 Fax : 880-2-8130102 Website: www.baec.org.bd

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Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

Event List

N AT I O N A L E V E N T S Indian Pharma Expo 2012 Indian Pharma Expo 2012 is the perfect solution to meet the needs of the rapidly growing Indian pharma industry; to be able to network under one roof. There will be discussions on regulatory issues affecting the pharma market, commercial strategies and business models of key players, maximising revenue, overcoming challenges and achieving growth and revaluating possible development scenarios; September 22-23, 2012, Pragati Maidan, New Delhi 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

2nd Pharma Supply Chain Forum

Now in its 2nd year, Pharma Supply Chain Forum is India’s premier pharma supply chain and logistics event in India covering a comprehensive range of supply chain topics including network optimisation, lean management, inventory management, security management, cold chain management, supplier-partner relationship management, packaging technology, forecasting & sourcing, and pedigree compliance; September 27, 2012, Taj Lands End, Mumbai For details contact: Kamikaze B2B Media Tel: +91 22 613 81800 Email: bhumika@kamikaze.co.in

Website: /www.elscconclave.com/ pharma.html

Lab Expo & Conferences Coimbatore It is an event that 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 witness attendance from a considerable number of professionals who have been involved in the industry for quite some time; September 28-30, 2012, Codissia Intek Technology Centre, Coimbatore For details contact: Paramount Exhibitors Tel: + 91 172 2274801 Fax: + 91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.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.’ The event will also provide excellent networking opportunities. 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

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

HYDERABAD

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

Andhra Pradesh, May 31- June 3, 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

Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@network18publishing.com

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

Automation 2012 This is a prolific trade show that strives to present a wide range of scientific, laboratory, biotechnology equipment. The visitors will be highly benefitted from the event as there will be a conference too at the event. The event will also provide excellent networking opportunities. The event will be focussing on clinical research and will be attended by industry leaders; November 2-4, 2012, Hyderabad International Trade Exposition Centre, Hyderabad For details contact: S D (India) Corporation Tel: + 91 11 4703 4600

Fax : +91 11 4705 6500 Email: info@indialabexpo.com Website: www.indialabexpo.com

P-MEC India P-MEC India, the most well attended and talked about Pharmaceutical Machinery, Equipment and Technology event. In this event the leading Indian and international pharmaceutical machinery exhibitors showcase their latest technologies and announce product launches. P-MEC focuses on key challenges in pharmaceutical services to develop more efficient production routes and systems of increasingly complex healthcare products. Technology demonstrations and onsite seminars will complement your visit to the show floor; 21 - 23 Nov, 2012, Bombay Exhibition Centre For details contact: Chaitali Davangeri UBM India Pvt Ltd Tel: +91-22-6612 2642 Email: chaitali.patil@ubm.com Website: http://www.pmec-india.com/

I N T E R N AT I O N A L E V E N T S 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

10th Functional Genomics Screening Strategies This event will cover the latest use of chemical genomics tools, potential use of micro RNA (miRNA), and long coding RNAs for identifying and validating drug targets, exploring unknown cellular pathways and for performing translational studies such as biomarker discovery, drug modifier screens, etc. In other words, this event aims to be a massive success; October 2, Boston, USA

For details contact: Cambridge Healthtech Institute Tel: + 781 972 5400 Fax: + 781 972 5425 Email: chi@healthtech.com Website: www.discoveryontarget/RNAiScreens-Functional-Genomics.com

CSBio 2012 CSBio 2012 will also cover the engineering sciences related to the pharmaceutical industry, in both material and manufacturing sciences. This conference would like to gather like minded researchers and industrial counterparts who are involved in designing, developing and improving industrial processes and equipment for large-scale chemical and pharma manufacturing; planning and testing methods of manufacturing; developing methods for the treatment of bi-products; devising production processes that are safe, efficient, profitable and environmentally sound; October 3-5, 2012, Bangkok, Thailand For details contact: School of Information Technology Tel: +66 2470 9834 Fax: +66 2872 7145 Email: csbio2012@sit.kmutt.ac.th Website: www.csbio.org

BIO-IT World Europe 2012 With the slogan ‘Enabling Technology. Leveraging Data. Transforming Medicine’ the 4 th

annual BIO-IT World Europe 2012 attracts life sciences, pharmaceutical and IT professionals to share the research advances, information trends and new enabling technology driving today’s biomedical and drug development. This event aims to cater to all the professionals from the industry and hopes to be a sure success in this regard; October 9-11, 2012, InterContinental, Vienna, Austria For details contact: Cambridge Healthtech Institute Tel: + 781 972 5400 Fax: + 781 972 5425 Email: chi@healthtech.com Website: www.bio-itworldexpoeurope.com

CPhI Worldwide The event hosts over1900 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 subsectors 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

2012 Nanotechnology Conference The event aims to bring together a panel of highly-accomplished nanotechnologists and well recognised authorities in various aspects of nanomedicine. This unique international conference offers an opportunity for pharma scientists, clinical researchers, physicians, therapists and industrial leaders to discuss the important international breakthrough developments in drug discovery, drug development, drug delivery, drug therapy and commerce to share their thoughts and exchange ideas and knowledge. It will also serve as a platform for networking. The fourday conference will focus on the basic studies through translational efforts and clinical trials and address topics of novel issues concentrating more on recent advances, difficulties, and breakthroughs. This is how the event aims to reach out to the experts and decision makers of industry; October 31- November 3, 2012, Riviera Maya, Mexico For details contact: Zing Conferences Tel: +44 1223 750020 Fax: +44 1223 280270 Email: info@zingconferences.com Website: www.zingconferences.com

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.

Modern Pharma•16-30 Sept ember 2012

Event Preview

Pharma Supply Chain Forum

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

ow in its second year, Pharma Supply Chain Forum is India’s premier pharma supply chain and logistics event covering a comprehensive range of supply chain topics including network optimisation, lean management, inventory management, security management, cold chain management, supplier-partner relationship management, packaging technology, forecasting & sourcing and pedigree compliance. On September 27, 2012, 2nd Pharma Supply Chain Forum will take place at Taj Lands End, Mumbai. This year too the event will be organised by Kamikaze B2B Media.

Opportunities galore At the 2nd Pharma Supply Chain Forum one will have the opportunity to learn about assessing the pharma supply chain scorecard: how one performs vs other industries and removing the roadblocks to an agile, efficient supply chain; collaborate with strategic

Assessing the pharma supply chain scorecard With the tagline as ‘Agile, Efficient Supply Chain’ the 2nd Pharma Supply Chain Forum aims to address all the relevant issues pertaining to pharma Supply Chain Management (SCM). The event, replete with discussions and roundtables, is looking forward to a mega success. A preview… partners to manage the supply chain on a global level; build an integrated supply chain network to achieve high level of accuracy in forecasting, sourcing and inventory management. Dignitaries present would be Surendra Deodhar, Head – Material Management, Reliance Life Sciences Pvt Ltd; Srinivas Iyer, GM - Supply Chain, Thermo Fisher Scientific India Pvt Ltd; A Jagannatha Reddy, Sr VP – Supply Chain Management, Mylan Laboratories Ltd; Thomas Lobo, Director – Global External Supply, India Region, Pfizer Pharmaceuticals India Pvt Ltd; Ryan Viegas, VP – Supply Chain & Procurement, Watson Pharmaceuticals Ltd,

In retrospective...

B Raveendran, Director Distribution and Logistics, MSD Pharmaceuticals Pvt Ltd. Further, there will be Rajiv Sharma, GM– Supply Chain, Panacea Biotec Ltd; Olivier

Brusle, Managing Director, Supply Chain Foundation, Manas Sahoo, Asst. VP - Supply Chain, Fresenius Kabi India Pvt Ltd, etc. Discussing the USP of this year’s event, Bhumika

Rathod, Project Manager, Kamikaze B2B Media, avers, “This year will be different in terms of people attending the event. Last year, it was a small venue and 75-80 people had attended the event. This year the event will witness approximately 150 people.”

Highlights of the event The event will provide a fresh perspective from a wide range of pharmaceutical, biopharma and medical device companies, which one can be used to draw ideas on initiatives to implement back at the company. The conference aims to deliver the most detailed and in-depth conference agenda seen to date, address comprehensive supply chain issues for the pharma industry. There will be interactive think tank roundtable discussions where one will get the opportunity to bounce around ideas with other leading supply chain executives to determine best practice and what has/has not worked in different areas. One will have the opportunity to meet the speakers and build relationships with valuable industry colleagues to help address the latest supply chain issues.

Book Review Handbook of Pharmaceutical Excipients Pharmaceutical excipients are an important component of the formulated dosage forms, often determining the quality, bioavailability and stability of the active ingredient. The book is an internationally acclaimed reference work in pharmaceutical excipients and the seventh edition has added 40 new monographs to the existing 340 listed excipients. The excipients are described as monographs each comprising of 22 sections. Every monograph starts with the basic nomenclature, chemical structure and CAS registry details. Monographs benefit from a standardised, easy-to-use template and include: pharmacopoeial information from the UK, Europe, Japan and the United States where relevant non-proprietary names and synonyms chemical name, CAS Registry number, empirical formula, molecular weight functional category, applications and incompatibilities material description and typical excipient properties safety, stability, storage and handling information method of drug manufacture. The practical needs of the industry are outlined in the functions, properties, specifications, applications, stability, manufacturing methods, safety, regulatory status and other sections of the monograph. The sections describe every aspect of the excipients in a short and simple manner. This book can be used as a daily reference guide for everyone in the pharmaceutical manufacturing and development industry.

Editor: James W Munson Price: ` 3,495/-

Publisher: Informa Healthcare Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

Editors: Raymond C Rowe, Paul J Sheskey, Walter G Cook, and Marian E Fenton Price:

` 24,000/-

Publisher: Pharmaceutical Press Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

Pharmaceutical Analysis: Modern Methods. Part A & B Analytical techniques in chemistry have evolved over a period of time and so have their modifications. With multiple analytical techniques available to the chemists, quality control personnel or regulators it becomes difficult to choose one over the other. This work by James Munson attempts successfully to educate the pharma industry on which solution to use for which problem. Divided over two parts, these two books are fairly technical, comprehensive, and not for a casual read. Part A of the work deals with chapters dedicated to gas chromatography, pyrolysis gas chromatography, mass spectroscopy, fluorescence spectroscopy and radio immunoassay. Part B has dedicated chapters on high-performance liquid chromatography, thin layer chromatography, functional chemical group analysis, flow injection techniques, electro analytical methods, atomic spectroscopy and the further advances in the same. Each chapters starts with the basics and definitions of the term involved. The chapter then goes on to describe the current theories prevalent in that analytical method and its applications in problem solving. Multiple illustrations and flow charts make understanding simpler. The book is a complete compilation of all the old and new techniques available to chemists for pharmaceutical analysis. The book would efficiently guide chemists, QC personnel or regulators in choosing the right solution to the right problem.

Reviewer: Dr Mandar Kubal, Consultant - Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC) Pvt Ltd

Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

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 Gas detector Gasman pockettype gas detector (monitor) is small, lightweight and easy-touse in tough environments. It weighs between 105-130 gm, depending on the sensor type. It is durable with high impact resistance and ingress protection to IP65/67. When a hazardous gas is detected, the device alerts the user with a loud 95 dBA alarm, a bright red blue visual warning and also by vibrating. It is small enough to fit easily into to a top pocket or clip on to a belt or lapel. It features single button control and full interchangeable I-module intelligent sensors for oxygen, toxic and flammable gas monitoring.

Features include pan construction with air-tight cover to provide good condition for mixing and drying. For sugar-coating, the hot air supply and the exhaust can be automatically controlled by the auto damper and the sequence spray-pause-1, pause-2, dry is automatically operated by the preset timer. The reverse rotation discharge system, discharges with simple operation without any damage of tablets.

needed body energy and are useful for senior citizens.

Umang Pharmatech Pvt Ltd Dist Thane - Maharashtra Tel: 0250-6450835 Email: info@umangpharmatech.com Website: www.umangpharmatech.com

FRP storage tank

Electric blanket

Detection Instruments (I) Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27617663 Email: sales@detection-india.com Website: www.detection-india.com

Tablet coating system The tablet coating system is available in various models from laboratory scale up to tonnage capacity. All models are in compliance with GMP requirements.

Aristocrat electric blankets are water proof, 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

Powder characteristics tester

Medico Pharmaceuticals Processors Amritsar – Punjab Tel: 0183-2258586 Mob: 09356000059 Email: info@medico.co.in Website: www.medico.co.in

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.

The Hosokawa PT-X powder characteristics tester employs methods to determine the flowability and floodability of dry powders. This model is the latest design of the powder characteristics tester, which utilises state-of-the-art features to identify the specific characteristics of powdered samples for a wide range of application fields. Features are automated vibration with electronically controlled vib-sensor for repeatable results, optional integrated HEPA filter dust protection, test sieve identification measure by recording test sieve serial number, complete powder characterisation in one instrument, reduced operator intervention insuring analysis accuracy and repeatability, user-friendly software, reduce analysis time, complies with FDA tapped bulk density (USP) ASTM, Kawakita’s equation for Compressibility, etc.

EPP Composites Pvt Ltd Rajkot - Gujarat Tel: 02827-287059 Email: marketing@epp.co.in Website: www.atikagroup.com

Hosokawa Micron India Pvt Ltd Chennai - Tamil Nadu Tel: 044-26211257 Email: mail@hmindia.hosokawa.com Website: www.hosokawamicron.co.jp

invite that

rewards as well... Dear Reader, ‘Modern Pharma’ 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 1,200 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.

1-15 Sept ember

Scan this code on your smart phone to visit www.mph online.in

2012 I Vol 1 I No 5 I `100

In Conversa

tion With

Shyam S Bhartia CMD, Jubilant Life Science s Ltd

Pharma indus grow to $ 60 try pegged to billion by end 12th Plan of

Special Focu

s 18

Funding in biotechnology A wavering graph

Interface

Anuradha Acharya Founder & CEO, Ocimum Biosolu tions

Automation

Trends 22

Plant automa tion Reducing cost in ensuring regulatory compliance

Post quarte rly results: Challenges expected in the future

UR Associ ates recentl y report on pharma sector. released its to the report, According overall pharm was pegged a industry at ` 1000 the domes billion with tic pharma THE financ industry at ` 600 billion ial results over companies of pharm pharma industrin 2009-10. The Indian for the quarte a y accounts in June 2012 r ending cent of the for 20 per global Despite registe have been mixed During the th generics industr bag. y. 11 Plan, several challen ring immense growth the domes market grew tic at 14 per future. The ges stay lined up for , and export cent the general trend CAGR s grew at 19 this quarte observed in per with anti-in r is fective, anti-as cent CAGR the sales but the significant rise anti-hyperten thmatic and in a decline in sive being The reason the profits therapeutic the major s stated by . categories. these thin margins are companies for Forex losses delays in produc Universal fl and t launches. Pharma’s Aurobindo says NIH u vaccine in reach, net sales increased suffered a THE first but net loss due universal in manuf to increase flu all ages is acturing in reach, thanksvaccine for costs and losses. Despit vaccine prime, Forex to a DNA in sales the e tremendous increa National Institu according to the US companies se te of Health comparativel have record The quest ed (NIH). y for Laboratories lesser profit. Ranba that can protect an influenza vaccin xy report e ed Dr Sharma against all a ` loss due to the virus has foreign exchan 586 crore been difficu strains of sales in the ges despite using a primelt. However, US. Dr Dangi East, said, The govern in mice paves boost vaccine regime “The projec ment project n growth rate ted domes the way for of the pharm ed the growth tic For team found delivery; the a example, that the correct to be unreal of 21 per cent seems per cent by industry to be around Nexavar of could be istic on revenu antibodies 2016-2017. 18 Nation now Spryce Bayer and produc ll of BMS. predict several es. With Industry gurus al Pharm existing immun ed even with preThe compu licensing aceuti cal challenges Authority ity to flu. lsory of the drug companies Pricin g that pharm (NPPA) contem are Bayer to being Nexavar from a idea of plating the unpredictable likely to face in future, reducing prices Bilcare to sell cent and has its price down by 97 government almost and globa prima per bringin policies being 70 per cent led l clinical supplies biz facie. of the indust g innovation and to a debate between under price for ` 340 the implem The uncertainty about affordability. BILCARE ry has control this entation of also filed highly unlike Ltd recentl crore Novartis figure Pharm the looks the a case to y stated that National it will sell aceutical Policy ly.” The govern exclusivity its global maintain plans to ment also 2006 that proposed clinical supplie rights of business was referen bring all patented drugs to contro drug Glivec. in the US its cancer s l 348 the ce under pricing essential price of and UK $ 61 million a model and Uncertain for expected (around ` this meddle with drugs is expected government to Irelan 340 crore) to indust to have a major impact is also likely to have policies are the plans d-based pharm ry. on Dr United a of the investm Plc. The two a companies. great effect Ajit Dangi, many CEO, Drug President on the parties have Danssen Post the and explain ent in this sector. definitive signed a quarterly Dr Dangi agreement “Research-ba Consulting, explain s, predicted for the sale. ed, reform “Slowing down of The agreem sed MNCs growth appear results, the the economic s and downg ent will have also pause button with chang s a challen allow Bilcare GCS Asia rading of ge patent on introducing hit economy es expect to leverage Indian government by major ed ed in new rating United deep capabi the develo drugs in India due policies. Dr internationa lities and resour Drug’s agencies as Sharma, Associ to pment of Ajay Kumar l and Europe well ces in US granting compurecent of FDI in ate Direct . licensing pharma sector as ambiguity & Biotech, or - Pharm Healthcare has a generi for patented drugs to lsory investment & Sulliva Practice, Frost climate uncert also made c manuf Indian for FDA approves n, South acturers ain MNCs but ambiguous Asia & Middl based on Lucentis to also for Indian not only diabetic macu criteri looking for a of ‘afford e and ‘paten lar edem treat ability’ JVs, collabo companies t not worke THE US It is estima FDA approv a d in India’. ted that over rations etc. for the ed Lucent ” ` 3,000 crore treatm is macular oedem ent of diabet Continued ic on page 8 a, a sight-t ANTHEM eye disease hreatening Biosciences, that occurs Bengaluru-ba a be to with diabete in people sed Discov provide early s. Research ery pre-cli stage The drug’s Allianc nical drugs (DRAP) compa e Partner along testing were establis safety and effectiveness with produc ny dedicated hed in two crore. It to suppo tion of clinical studies involving small scale would also rting resear 759 patien increasing protein be efforts in ch enzym ts who were treated and its manpo the discov es and large s and followed for wer with an aim of ery chemic Lucentis is scale new al synthesis. compo unds marketed by three years. more project to undertake by Sharing Genentech. details on s in pharm started with future. “We the same, biotechnolog aceut ical, Ajay AstraZeneca 200 people y, Bharad speciality MD resigns and today chemi cals, ANAN DH Anthem BioSciwaj, CEO, we agricu lture Balasu ndara people workin have 400 ences, said, chemicals resigned as “We are and materi MD and memb m has expanding future as the g with us. In science compa al facility Board of AstraZ our er by adding nies, is completion, project nears eneca Pharm of the the proces The compa we would a, India. s of expand in 200,000 square another ny said that adding anothe be its existin ing new feet of relived with he would r g labs, which be effect from Sharma informed Bharad100 people,” Bommasandr facility at includ Augus company has, a, Bengaluru. e a GMP would as an interim t 31. The Anthem wouldwaj. The facility animal appointed facility, measure, We would Jonathan Hunt also be investing also be increas to be functio is expected facility fermentation pilot President, as COO and ` 100 nal our and also new for a manu factur ing setting up anothe crore in three month in the next In commencing period of four month labs. capaci addition r facility in ing Kanak s. The main s September ty by to this, we function of pura, Bengal 1. are also this facility existing capacittripling the the uru with adding more will chemi motive to y.” stry synthe To set up scale chemic provide large sis labs. al synthesis Anthem has this facility fermen and invested ` tation to its 25 clients.

Anthem to

expand its

facility in

Bengaluru

- Jasleen Kaur Batra

The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly 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 advertisers 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,

Manas R. Bastia “Disclaimer: Network18 Media & Investments Limited is proposing, subject to market conditions and other considerations, an offer of its equity shares on rights basis and has filed a Draft Letter of Offer with the Securities and Exchange Board of India. The Draft Letter of Offer is available on the website of SEBI at www.sebi.gov.in and the websites of the Lead Managers at www.icicisecurities. com and www.rbs.in. Investors should note that investment in equity shares involves a high degree of risk and are requested to refer to “Risk Factors” in the Draft Letter of Offer. The Equity Shares have not been and will not be registered under the US Securities Act of 1933, as amended (the “US Securities Act”), or any state securities laws in the United States and may not be offered or sold in the United States or to, or for the account or benefit of, “U.S. persons” (as defined in Regulation S under the US Securities Act) except in a transaction exempt from the registration requirements of the US Securities Act and in accordance with any applicable U.S. state securities laws.”

Senior Editor Modern Pharma

Network18 Media & Investments Limited ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W) Mumbai 400 028 India

D +91 22 3003 4669 T +91 22 3024 5000 F +91 22 3003 4499 E manas@network18publishing.com W www.network18publishing.com

Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

Products

Dual wavelength diffractometer Its Mova source is up to 2.5x more intense than a standard Mo sealed tube X-ray source. Its Nova source (Cu) up to 3x more intense then a 5kW rotating anode with optic. It has simple and automatic switching between wavelengths. This is ideal for small molecule and protein crystallography and is fast, high resolution, automated data collection and processing. It has optional aircooler radiator for a self-contained system independent of any external water supply. Agilent Technologies India Pvt Ltd New Delhi - Delhi Tel: 91-011-46237100 Email: agilent@agilent.com Website: www.agilent.co.in

Pumps E-Series AirOperated DoubleDiaphragm (AODD) pumps are self-priming and provide gentle displacement of fluids. They are equipped with the patented PERSWING P® air control system, which ensures accurate reversal of the main piston and is characterized by low noise levels. They are created from a solid plastic block, offering advantages like increased pump security due to an innovative ring-tightening structure, increased capacity, decreased air consumption, reduced noise level, optimized flow pattern and a pulsation damper suitable for flange connection. Dover India Pvt Ltd Chennai - Tamil Nadu Tel: +91-44-26271020 Email: akmurthy@destaco.com Website: www.doversolutions.co.in

De-humidifier The AD 420 dehumidifier is incorporated with fully hermetically sealed rotary c o m p r e s s o r, protected a g a i n s t overloading and vibrationinsulated bearings. It has an axial fan with plastic fan wheel (with winding protection). Condenser and evaporator are made from copper piping covered with aluminium fins. Cooling circuit is made from copper piping with capillary tube and filter dryer. There is a service connector on the suction side. Automatic defrosting is controlled by Dry-Logic. The casing is aluminium, powder-coated & offers protection class IP X4. Origin Dehumidifiers Mumbai-Maharashtra Tel.: 022 – 22044156, Fax: 022 – 22875114 Email: sales@origincorp.com Website: www.origincorp.com

Spectrophotometer

The Optizen 3220UV is used for analyzing components that require multiple wavelengths, time course operations and getting stable data sheets. It has USB ports for user-friendly programming updates and other accessory connections. It has universal sample cell holder that holds 8 cells. It has superb optics for maximized accuracy, exceptional precision and reliability. It has user-friendly software with scanning and time course capacities with versatile data processing. Jay Instruments & Systems Pvt Ltd Navi Mumbai-Maharashtra Tel: +91-22-2767 2955/0092 Email: ledsales@jayinst.com Website: www.jayinst.com

TrayCell The TrayCell is a fibre-optic ultra-micro cell designed for the UV/Vis micro volume analysis of DNA/RNA and proteins. It is designed for measurements of DNA/ RNA or protein samples and enables highly accurate analysis of extremely small samples with remarkable reproducibility. Its dimensions are equivalent to a standard cuvette in order to work in most spectrophotometers. It is used for nucleic acid analysis, determination of the incorporation frequency of fluorescent dye labels (FOI), protein analysis (A280, BCA, Lowry etc.) & all UV/Vis analysis utilizing the wavelength range of 190 to 1100 nm. Hellma GmbH & Co. KG Müllheim-Germany Tel: +49(0) 7631/182-0 Fax: +49(0) 7631/135 46 Email: info.analytics@hellma.com

Moisture analyser balance

Tablet hardness tester

The portable Tablet hardness tester model iHT 100 is designed for simple, inexpensive & “in-situ” measurement tablet hardness testing. This enables the user to react quickly to adjust the compression force of a tablet press and reduce the costs created by tablets produced out of specified hardness limits. The safety cover is to be opened; the sample placed in the measuring station and is pressed against a metal plate (connected to an electronic load-cell) moved by a hand wheel, until the sample brakes. The result of the measurement is shown on the built-in-LCD in N, Kg or lb. Every time the unit is switched ON, it fulfils an automatic half-calibration (zero calibrated). Erweka India Ahmedabad-Gujarat Tel: +91 92280 22065 Email: sales@erwakaindia.com Website: www.erwakaindia.com

Capsule filling machine The automatic capsule filling machine is an encapsulation equipment. Its features include compact, sturdy, covered with stainless steel panels, hood covered with acrylic guard. The fill weight adjustment takes place within seconds. It is provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation with ±2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. Faulty capsule and filled capsule ejection stations come with individual air controls. It is simple to operate and easy to maintain and has special purpose gauges for quick and easy change over. Anchor Mark Pvt Ltd Mumbai - Maharashtra Tel: 022-28682001, Mob: 09320036904 Email: sales@anchormark.com Website: www.anchormark.com

FRP storage tank

The new MB series moisture analyser comes with halogen heating which removes moisture from entire area of the sample. It has user friendly visualization display for process of drying & selection from four profiles for drying. It gives detailed print out of the analysis in compliance with GLP/GMP standards. It has a built-in RS 232C interface for PC or printer & large LCD display with AEP (Advanced Eye Protection).

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-tomaintain featuring good physical and mechanical strength. The reaction vessel is available with suitable lined agitator, gear box and electric motor.

Citizen Scale (I) Pvt Ltd Mumbai-Maharashtra Tel: 022-4243 770; Fax: 022-4243 7800 Email: channel@citizenscales.com Website: www.citizenscales.com

EPP Composites Pvt Ltd Rajkot - Gujarat Tel: 02827-287059 Email: marketing@epp.co.in Website: www.atikagroup.com

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 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 three-point 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

Ball valve This ball valve comes with pneumatic rotary actuator. The valve is of on/off type with screwed, flanged, socket weld, triclover end in threepiece design. It is available in SS-304 and SS-316 investment castings and is fitted with doubleacting pneumatic rotary actuator that operators through 90-degrees angular movements of ball valve or butterfly valves. Pneumatic actuator is mounted directly on the shaft of the valve. The actuator is supplied with solenoid valve mounted on it. It is available in different sizes up to 4” to control fluids such as steam, chemicals, oil, air, and water. Madho Controls Pvt Ltd Thane - Maharashtra Tel: 022-25883252, Mob: 09820066046 Email: madho@vsnl.com Website: www.madhocontrols.com

Air-cooled single-stage pump The oil-lubricated air-cooled singlestage pump comes with multi-vane built-in anti-suck back system. It is provided with oil recirculation system having exhaust filters to produce mist-free exhaust. The pump is available with capacities ranging from 15 m³/hr to 150 m³/hr. The pump is used in various applications like packaging, bottle filling, pick and place, leak detection, heat treatment, distillation, suction in hospitals, oil purification, degassing and drying, etc. Advantages of the pump are less oil, less power, noise less and pollution free compared to normal oil seal vacuum pumps. Toshniwal Instruments (Madras) Pvt Ltd Chennai - Tamil Nadu Tel: 044-26252716 Email: sales@toshniwal.net Website: www.toshniwal.net

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 Pharma

Modern Pharmaâ&#x20AC;˘16-30 Sept ember 2012

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Mod e r n P h a r m a •16 -3 0 S e p t e m b e r 2 012

30 List of Products & Advertisers 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

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2nd Pharma supply chain forum .......................FIC

Encoder ....................................................................... 7

Motorized chain pulley block ................................ 29

machine to the complete filling line ..................... 29

Activated carbon filter .......................................... 27

EOT/Hot cranes ....................................................... 29

Octagonal blender ................................................BC

Stainless steel pipes .................................................. 29

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Flame proof hoist .................................................. 29

Photo electric sensor............................................... 7

Switching relay ........................................................... 7

Air-cooled single-stage pump ................................ 32

Fluid bed dryer .......................................................BC

Plastic masterbatches............................................... 29

Tablet coating system............................................ 30

Ball valve................................................................. 32

FRP storage tank...................................................... 32

Powder characteristics tester................................... 30

Tablet hardness tester .............................................. 32

Beta lactum & oncology with complete

Gas detector............................................................ 30

Pressure sand filters ................................................. 27

Tablet inspection machine.....................................BC

Blow-fill seal machines.............................................. 9

Gear boxes ................................................................ 29

Programmable logic controller ................................ 7

Bottom discharge centrifuge .................................. 32

Goliath crane ............................................................ 29

Programmable terminal............................................ 7

Capsule filling machine ........................................ 32

Goods Lift ................................................................. 29

Proximity sensor ........................................................ 7

Chain pulley block................................................... 29

Industrial control & sensing device ...................... 7

Pumps ....................................................................... 32

Color masterbatches ................................................ 29

Invertor/variable frequency drive ............................ 7

Rapid mixer granulator .......................................BC

Complete range of filling & crimping

Jib crane .................................................................. 29

Reverse osmosis unit ............................................... 27

machines for aerosols .............................................. 29

Lab water sysytem ................................................... 3

RFID ............................................................................ 7

Counter & power supplies........................................ 7

Large diameter welded pipes.................................. 29

Rotary vacuum pump ............................................. 30

Crabs ......................................................................... 29

Level controller .......................................................... 7

Safety light curtain .................................................. 7

Crane ......................................................................... 29

Machines & plants for dry & wet preparation BIC

Saftening unit ........................................................... 27

De-humidifier ........................................................ 32

Measuring & monitoring relay for 1Ph/3Ph .......... 7

Seamless pipes .......................................................... 29

Dual wavelength diffractometer ............................ 32

Moisture analyser balance ...................................... 32

Semi auto coater .....................................................BC

Effluent treatment plant....................................... 23

Monorail trolley ....................................................... 29

Spectrophotometer .................................................. 32

Wire rope Hoist ....................................................... 29

Electric blanket......................................................... 30

Motion control........................................................... 7

Spray systems-from the single

Work bench .............................................................. 30

Tablet press machine ............................................... 21 Tempurature controller............................................. 7 Timer ........................................................................... 7 TPU masterbatches.................................................. 29 Transfer trolley ......................................................... 29 Tray dryer.................................................................BC TrayCell ..................................................................... 32 Tubes ......................................................................... 29 ‘U’ Tubes ................................................................. 29 Ultra filteration system. .......................................... 27 Vision sensor............................................................ 7 Waste water treatment plant ............................... 23 Welded pipes ............................................................ 29

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Advertiser’s Name & Contact Details

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All Pharm Technologies Pvt. Ltd.

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Kamikaze B2B Media

FIC

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Salesworth India Pvt Ltd (Rommelag)

T: +91-022-26849100

T: +91- 9969428590

T: +91-80-25274495

E: mail@allpharm.in

E: bhumika@kamikaze.co.in

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W: www.allpharm.in

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Alok Masterbatches Ltd

Netzsch Technologies India Pvt Ltd

BIC

Suraj Limited

T: +91-011-41612244

T: +91-044-42965121

T: +91-79-27540720

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A.T.E. Enterprises Pvt. Ltd.

Omron Automation Pvt. Ltd.

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T: +91-79-25830742

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Heattrans Equipments Pvt.Ltd

Pamasol Will Mader Ag

T: 41-55-417-4040

T: +91-022-67162200

E: info@heattrans.com

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Indo German Pharma Engineers

Prayag Polytech Pvt Ltd

TSA Process Equipment Pvt. Ltd.

T: +91-0250-2200070

T: +91-011-47262000

T: +91-022-28593808

E: indogmbh@vsnl.com

E: delhi@prayagmb.com

E: base@tsapepl.com

W: www.indogermanpharma.net

W: www.prayagmb.com

W: www.tsawatersystems.com

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Thermo Fisher Scientific India Pvt. Ltd.

T: +91-079-2584015

Techno Industries

T: +91-20-2729 3942/0831

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