Modern Pharmaceuticals - 1-15 August 2012 by Infomedia18

1-15 Augus t 2012 I Vol 1 I No 3 I `100

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In Conversation With 16

Special Focus 19

Insight & Outlook 22

Roundtable 23

Art Caputo President - Waters Division, Waters Corporation

Clinical research and database management Addressing the regulatory challenges

ERP systems Putting operations on track

Should India tax air tickets to pay for AIDS drugs as proposed by the UN?

Abbott introduces OneLab AS health care systems around the world face challenges such as labour shortages, increased regulation and budget constraints, they rely on technology to help manage the impact. To assist in addressing these challenges, Abbott announced OneLab, a new, Web-based, integrated laboratory informatics solution. OneLab is a highly-configurable platform that allows labs of any size to standardise processes across multiple locations and automate routine procedures such as sample management and tracking, as well as test result review and approval.

Taro Board rejects Sun Pharma offer for complete acquisition TARO Pharmaceutical Industries’ board has rejected an offer from Sun Pharmaceutical Industries to purchase its issued and outstanding shares not held by the Indian pharma firm due to inadequate price. “Special Committee of Board of Directors unanimously rejected the October 18, 2011 unsolicited, non-binding offer from Sun Pharmaceutical Industries to purchase all of the issued and outstanding shares of Taro not currently held by Sun Pharma for $ 24.50 per share as inadequate and not in the best interests of Taro’s minority shareholders,” a statement on Taro Pharmaceutical’s website stated.

Piramal Healthcare to be renamed post diversification PHARMA major Piramal Healthcare will be renamed as Piramal Enterprises following its recent entry into diversified business activities. The rechristening comes four years after Nicholas Piramal became Piramal Healthcare. “To appropriately reflect the company’s changed business profile, it is proposed that the name of the company be changed to Piramal Enterprises Ltd,” Ajay Piramal, Chairman, Piramal Healthcare, stated at the annual general meeting.

Zydus Urosciences launches Udenafil ZYDUS Urosciences, the specialty division of Zydus Cadila has launched Udenafil a next gen therapy for the treatment of Erectile Dysfunction (ED). Udenafil, a newly developed, potent and selective PDE5 inhibitor approved for the treatment of ED, has been launched under the brand name Udzire. The group has an exclusive license to market this patented molecule developed by Dong-A Pharmaceuticals of Korea, in India.

Ideal cures develop Instamodel system for ER formulations IDEAL Cures has developed an extended delivery system named Instamodel that allows the release of any drug for a longer period of time with continuous availability of medication to patient or user, and thereby cuts the frequency at which such doses have to be administered. Suresh Pareek, MD, Ideal Cures said, “Instamodel will be targeting the midsized pharma companies who do not have proper infrastructure for the development and still they would like to have the Extended Release (ER) range of products in the market. Other customers can also use our expert systems and technical support to reduce the time and expenses for development. These will be the simplest of the solutions that will allow the conventional or prevailing set up to produce specialised high quality products at no extra cost.” Pareek added, “The projects on the Instamodel for ER tablets formulations have come up with several products and

Pareek

many more are on the anvil. Besides the work on neutral spheres, cooling compounds and some new film coating composition is under progress.” While film coating is its core business Ideal cures also plans to focus

on specialised excipients that will add value to the products and facilitate the manufacturing and enhance the product quality and attributes. On the future plans Pareek commented “We have very ambitious plans for future and would like to grow in double digits (about 30 per cent) of percentage on yearly basis. Ours will be science and research based organisation and our approach will be to bring out innovative products to support growing pharma industry.” Elaborating on its business in India and its future expanding strategies, Pareek added, “Our major business as of now is in India and the revenue to 90 per cent extent is contributed by domestic business only. The business development globally is our major objective and in next 5 years we would like to see approximately 25 -30 per cent revenue being generated by off shore supplies.” - Shibani Shah

Shasun Pharma to start intermediates facility in AP, hire 100 people SHASUN Pharmaceuticals Ltd is all set to establish a facility at Naidupeta, Andhra Pradesh. And hence, constant efforts are being made at decreasing dependence on Chinese imports for its business. The company is one of the largest manufacturers of pain management drug Ibuprofen. According to Abhay Kumar, MD, Shasun Pharmaceuticals Ltd, the facility, under construction

Kumar

on a 50-acre land in Naidupeta, is expected to start operations by March 2013 with an annual

capacity of 12,000 tonne of intermediates. Elaborating in this regard, Kumar highlights, “This facility will be primarily serving two objectives. First, there would be nondependence on China for supply and second it would be assurance of timely availability of products.” He further added that the total investment would be approximately `100 crore.

Kumar added that the company is planning to recruit 100 people. He remarked, “We are looking at chemistry graduates or chemical engineers to work with us.” Setting up a facility is not an easy job to be done. Talking about the hurdles, he reiterates, “Technology remains still a challenge. We have to find cost effective ways in order to compete with the Chinese prices.” - Chandreyee Bhaumik

Proparco invests $ 12.50 million in Strides’ African arm STRIDES Arcolab Ltd has announced that Proparco, a French Development Financing Institution, has invested $ 12.50 million in the form of equity participation for a 20 per cent stake in Strides’ African front-end arm, valuing the African operations at about $ 60 million. The proceeds will be used to create additional manufacturing infrastructure in key markets in Africa and to build a regional

company with the philosophy of ’In Africa for Africa’. Strides has been present in Africa and contributing to the improvement of healthcare by manufacturing and marketing a wide range of lifesaving antibiotics, lifestyle disease related curatives and nutrition/ relief providing formulations. Sinhue Noronha – CEO, Africa Operations, Strides Arcolab Ltd, said, “Africa is the

most attractive business opportunity of tomorrow and this partnership with Proparco further strengthens our commitment to providing quality and timely medication to Africans. Creation of additional manufacturing infrastructure will also provide large employment opportunities and economic growth to all associated with the Strides’ African Business and reinforces our belief that life is most precious”

M o dern Pharma• 1- 15 A ugu s t 2012

CONTENTS In Conversation With

Art Caputo President - Waters Division, Waters Corporation

Special Focus

CRAMS CRAMS landscape in India The key drivers Clinical research and database management Addressing the regulatory challenges

18 19

Interface Abhay Kumar Managing Director, Shashun Pharmaceuticals Ltd

Sujay Shetty Partner - Pharma Lifesciences Leader, PricewaterhouseCoopers (PWC)

Insight & Outlook

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl

Automation Trends ERP systems Putting operations on track

proposed by the UN?

SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan

Roundtable Should India tax air tickets to pay for AIDS drugs as

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REGULAR SECTIONS 5 Editorial / Guest Editorial 6 News, Views & Analysis 24 Tenders 24 Projects 25 Event List 26 Book Review 27 Products 29 Marketplace 30 List of Products & Advertisers

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Mo de rn Ph a rm a •1 -15 Au g u s t 2 012

Editorial

Riding high on R&D hat’s common to two vastly diverse domains such as pharmaceuticals and automobiles in India? Of late, both the sectors (and they are not alone) are setting new milestones in terms of increasing investments in R&D. So much so, in case of some organisations, R&D expenses are rising faster than their respective top line figures. This was absolutely incogitable just a few years ago in the Indian pharmaceuticals sector, when a miniscule percentage of an organisation’s sales was going towards R&D. Today, the scenario has changed significantly with Indian pharma companies spending double-digit percentage figures of their sales in R&D, notwithstanding the headwinds of an ongoing slowdown in most parts of the West. In this context, the following words of Dr K Anji Reddy put things in the right perspective: “Excelling in the basic business operations will be necessary, but not sufficient. To maintain a long-term presence in the global pharmaceuticals markets and to grow profitably will require companies to be even more focussed on R&D and creation of successful Intellectual Property Rights (IPRs).” Added to this is the latest reported trend of pharma MNCs preferring to enter into alliances rather than outright acquisitions of their Indian counterparts. The numbers of partnerships that have seen the light of the day in recent months is a testimony to this. And, the reasons

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

behind this are not too difficult to fathom. As the pipeline of patent expiries gets longer and deeper as well as given the huge expenses involved coupled with high failure rates in developing new drugs, such partnership model appears more attractive of late. That said, the moot question here is do Indian pharma companies have the requisite pace and scale in adding value to their R&D investments, say, when compared to their peers in China and Japan? While the Indian pharma market is getting increasingly regulated, there is tremendous scope to leverage the emerging opportunities by a partnership approach based on a win-win valueadded model. Apart from sharing responsibilities, costs and benefits, such partnerships appear more appealing in the backdrop of recent amendments in the government’s foreign direct investment policy. It is indeed the need of the hour to hone innovation capabilities in order to offer world-class pharma products for several global markets. More importantly, all these recent developments promise the emergence of a level playing field, wherein there are ample opportunities for smaller size innovative companies.

Manas R Bastia manas@infomedia18.in

Guest Editorial

Europeanising the Indian way or the year 2010, Europe recorded a sale of $ 245.3 billion (finished dosage forms only), as per IMS data. It has imported over $ 48 billion (UN Comtrade) worth of formulations from countries other than Europe. The lion’s share of imports goes to USA. Imports from USA grew from $ 23.9 billion in 2006 to $ 32.3 billion in 2010 with a CAGR of 8 per cent and a negative growth of 6.5 per cent during 2010. Many reports suggest increase in the percent of genericisation of the market is the cause of low growth of the market in values though there is substantial increase in consumption. Hence, the situation indicates the growing acceptance of generics. India’s exports of pharmaceuticals during the year 2010-11 has been to a tune of $ 10.4 billion growing at 16.3 per cent and at 16 per cent CAGR over the period 2006-07 to 2010-11. Exports to Europe during 2010-11 were to a tune of $ 2.1 billion with a CAGR of 13 per cent during the last five years. As of Dec 31, 2009, India had 741 market authorisations from UKMHRA, which have contributed to 1 billion exports of formulations. During 2011-12 high value innovator drugs belonging to the therapeutic group of cardiovascular and central nervous system, (which is often used by the ageing population of

Europe) have gone out of patents. India has bagged more than 60 UKMHRA market authorisations for formulations, most of them belong to this group, totaling as on January 31, 2012 to 808 market authorisations. This will propel Indian exports of formulations at a higher pace than the previous years. It is estimated by many reports that during 2010 Europe’s generic market size could be in the range of $ 37-40 billion, which forms 16.5 per cent of the total market. Also, some of the east European countries such as Croatia, Estonia, Lithuania & Slovakia have generics contributing to 40 per cent of their total market size. In fact, it is only the generics market of Europe that is expected to grow and the patent part of it is expected to decline, keeping the overall growth rate at 0-3 per cent during the next 3 years. European market due to various factors, one of them being recession, is conspicuously trying to contain the health care expenditure. The component in such expenditure which could be contained better is obviously medicines by switching to generics. Most of the countries of this region have initiated such measures. The latest among them being Germany switching to unbranded generics, thereby all the generics are evaluated vis-à-vis price wise and not on brand’s weight.

While on one hand, Europe as a whole is eager to genericise more and at a faster pace to contain their health expenditure, but on the other hand they are slowing down the process of granting market authorisations to the quality producers of these generics, who in fact can play vital role in their objectives. The existing time frame for granting market authorisation is longer in comparison to USFDA. Introduction of more administrative measures cited in the new EU-directives for export of APIs is likely to cause disruption in supplies/availability. Otherwise, the situation is very favourable to global generic exporters around the globe. India, termed as ‘The Pharmacy of the World’ has a basket of wide spectrum of generics. Coupled with large vendor base, the country is well poised to contribute Europe’s effort of containing their health expenditure. It is hoped the ensuing India-Europe FTA might sort out most of the issues, which eventually will benefit both the sides. ‘Brand India Campaign’ which the Government of India has launched in March 2012 also helps to promote this image. Dr P V Appaji Director General, Pharmaceuticals Export Promotion Council of India

Mod er n P har m a•1 - 15 A ugus t 2 012

News, Views & Analysis

Agilent CrossLab services and supplies set to capture Indian market AGILENT Technologies, the global leader in the test and measurement industry recently launched its aftermarket solutions. These solutions will be called ‘Agilent CrossLab.’ Agilent CrossLab is the combination of multivendor services as well as supplies to customers who use non-Agilent instruments. Agilent had launched multivendor support services to customers as early as January 2010. CrossLab has gained prominent relevance in India. Further, more than 500 other manufacturers of non-Agilent instruments are under CrossLab Services.

Further, Agilent has deployed more than 40 engineers who are certified to service other manufacturer LC

Pasupathi

and GC across India. And more than 15 top pharma companies in India are already availing CrossLab Service. Recently, Agilent combined supplies and services

under one umbrella called Agilent CrossLab for ease of customer understanding. Among others, Agilent supports equipment and supplies of companies such as Bruker, Dionex, Perkin Elmer, Shimadzu, Thermo Scientific and Waters. Speaking on the launch, Siva Kumar Pasupathi, Country Manager, Life Sciences & Chemical Analysis Business, Agilent India, said, “With the launch of CrossLab, we are now closer to the customer than ever. And we have invested in every sphere of customer touch points, whether it is the number of engineers in the field, their training and certification,

Kemwell receives health Canada approval for its oral solids facility KEMWELL Biopharma has received approval from health Canada to manufacture and supply oral solid dosage products from its facility in Bengaluru to the Canadian market. The facility has been in operation since 2008 and received its first EMA approval in 2008. Speaking on the occasion, Anurag Bagaria, CMD, said, “This approval will give access to Kemwell’s current and prospective customers to the growing Canadian market. The approval also backs Kemwell’s commitment to becoming a global partner and providing high-quality products.” Kemwell already produces a wide range of products including un-coated, coated, effervescent tablets and capsules for the European, New Zealand and Australian markets and is awaiting its first USFDA audit later this year.

or maintaining an exhaustive inventory. We are well positioned to bring delight to every customer, even if their original equipment of choice was not from Agilent.” He added that now the solution will not only help the instruments of their company but also other companies. He highlighted, “It will be in the form of marketing activities” Seconding the above thought, Parmeet S Ahuja, President and Country GM, Agilent India, commented, “It is our commitment to our customers in India that this same expertise is available to them, even if they have equipment that is non-Agilent.”

Successful completion of phase 1 global study for biosimilar insulin Glargine BIOCON announced positive results from a phase I comparative study conducted in Germany of its biosimilar insulin Glargine in Type 1 Diabetes Mellitus (T1DM) patients. This study was conducted to evaluate pharmacokinetic and pharmacodynamic equivalence of the drugs against the innovator product (Lantus®). These robust clinical data generated to date between Biocon’s insulin Glargine and the innovator product will enable Biocon to start its phase III programme in the US and EU aimed at demonstrating comparative safety, efficacy and immunogenicity in patients. “This study clearly demonstrates that insulin Glargine is bioequivalent to LANTUS®, so that both insulins will have the same effect when used in identical doses and were well tolerated; without any serious adverse event observed during the four month study period,” said Dr Tim Heise, CEO - Science & Administration, Profil® in Neuss, Germany. Dr Kiran Mazumdar Shaw, CMD, Biocon, said, “Insulin Glargine is a key product in our growing portfolio of biosimilar insulins. The successful outcome of this critical phase 1 study demonstrates our strong commitment towards developing high quality biosimilars and paves the way for the phase 3 programme of biosimilar insulin Glargine that will enable regulatory approvals of our product across developed and emerging markets.”

Greenphire supports EU legislation to reduce clinical trial administration THE European Commission recently announced proposals to address increasing administrative costs and a decline in the number of cross-border clinical trials conducted in the European Union (EU). The proposed legislation, expected to be enacted by 2016, aims to speed up authorisation and reporting procedures while ensuring patient safety and data quality. Currently, companies or researchers seeking to conduct clinical trials in more than one

EU country must submit separate applications and reports in each country. Under the proposed new system, applicants will only have to submit this information once. The new regulation streamlines this process in order to make pan Europe an attractive place to conduct trials. According to John Dalli, European Commissioner for Health and Consumer Policy, the new legislation could save over 800 million per year in regulatory costs.

DNDi and Cipla to develop 4-in-1 paediatric ARVs combination THE Drugs for Neglected Diseases initiative (DNDi) has collaborated with Cipla to develop a 4-in-1 ARV combination product for HIV-infected children under the age of three years, including those who have been exposed to drugs while in the womb, and also those who are co-infected with TB. Dr Yusuf K Hamied, CMD, Cipla Ltd, said, “We have already been working with the Medical Research Council Clinical Trials Unit (MRC CTU) in the UK and their paediatric colleagues in

Dr Hamied

Zambia and Uganda for several years, first producing several appropriate baby pill formulations for

infants and children, and more recently we have produced a new sprinkle of lopinavir-ritonavir. Cipla and DNDi are now joining forces to produce further drug formulations for HIV-infected children in poor countries.” Cipla will provide its lopinavir/ritonavir (LPV/r) 40-/10-mg sprinkle formulation and work with DNDi and other partners to test new combinations of HIV treatment for infants and young children. Cipla will work to produce

an appropriate 4-in-1 combination sachet product, in which the four ARV drugs will be in taste-masked, granular form, for easy mixing into food or liquids with the aim of registering the drug by 2015. “This partnership with Cipla and other collaborators provides us a critical path to developing better paediatric anti-retroviral formulations for the youngest, most vulnerable patients living with HIV/AIDS,” said Dr Bernard Pécoul, Executive Director, DNDi.

John Blakeley, CCO, Greenphire, said, “Greenphire welcomes new measures to facilitate the implementation of cross-border clinical trials and ease administrative burdens. In addition to achieving its main goal, this legislation will also benefit research in areas such as rare diseases where there may be only a few subjects in each country, and which may otherwise face bureaucratic obstacles.”

GSK, HGS reach $ 3.6 billion deal GLAXOSMITHKLINE (GSK) plc and Human Genome Sciences (HGS) announced that the companies have entered into a definitive agreement under which GSK will acquire HGS for $ 14.25 per share in cash. The transaction values HGS at approximately $ 3.6 billion on an equity basis, or approximately $ 3 billion net of cash and debt, and represents a premium of 99 per cent to the HGS closing price of $ 7.17 per share on April 18, 2012, the last day of trading before HGS publicly disclosed GSK’s initial private offer. The Boards of Directors of both companies have approved the transaction.

Israel’s Teva to foray into India through JV with P&G T E VA Pharmaceutical Industries (TPI) shall foray into India through a JV with US-based Proctor & Gamble (P&G) and will set up its first manufacturing facility at Sanand in Gujarat. According to a state official, “TPI and P&G joint venture P&G Teva would set up Over The Counter (OTC) drug manufacturing facility at Sanand with an initial investment of

` 250 crore.” H G Koshia, Commissioner Food and Drug Control Administration (FDCA), Gujarat, said, “The total proposed investment in Gujarat by the JV is around ` 500 crore.” Around 15 acre of land for the project has already been acquired, Koshia said. A formal announcement is likely to be made after signing of MoU with the state government during

the Vibrant Gujarat Global Summit-2013 scheduled for January next year, according to sources. “The facility to come up on 15 acre of land is proposed to have two separate lines, one for manufacturing Ayurvedic drugs and another for allopathic medicines,” he said. A joint delegation of P&G and Teva recently visited Gujarat and evinced interest

in setting up a manufacturing facility here. “A four member delegation led by Teva Karin Baer, VP - Corporate Quality met us and sought details of setting up a facility to manufacture OTC products like cough syrups, inhalers amongst others,” Koshia said. Teva Haresh Gill, AVP, TPI and Seema Sundereshan, a senior scientist from P&G were part of the delegation,

he said. The proposed facility at Sanand would have state-of-the-art equipment and adhering to GMP norms to make products both for Indian and overseas market, Koshia said. A lot of global companies have evinced interest in setting up their facilities in Gujarat, an established hub for pharmaceutical companies, especially SMEs.

Mo de rn Ph a rm a •1 -15 Au g u s t 2 012

News, Views & Analysis

Johnson & Johnson launches OTC congestion relief syrup BENADRYL® announced the launch of its new congestion relief variant Benadryl® Congestion Relief that will help expectoration of cough with phlegm or wet cough and relieve chest congestion. Tushar Murdeshwar, VP Marketing, Consumer Division, Johnson & Johnson Ltd, said, “Benadryl® is an iconic brand with a strong heritage within our portfolio. It presents a tremendous growth opportunity for us. With the new variant, Benadryl® plans to expand its

range of specialist solutions to treat all types of cough-related ailments with care.” Gautam Suri, General Marketing Manager - Consumer Division, Johnson & Johnson Ltd, stated, “With the launch of Benadryl® Congestion Relief, J&J is taking its first step towards building a cough expert equity under ‘Benadryl.’ Further innovations planned under the brand for the next couple of years will empower consumers to self-medicate themselves with the right solutions basis their specific cough symptoms.”

Biostorage Technologies announces expansion in APAC BIOSTORAGE Technologies, a global provider of comprehensive sample management solutions for the bioscience industry, including storage, cold chain logistics and virtual sample intelligence, is expanding its services to the Asia Pacific region. This expansion includes the appointment of Jason Huang as General Manager of Asia Pacific (APAC). Headquartered in Singapore and operating in

China as a wholly owned foreign enterprise (WOFE), BioStorage Technologies Asia Pacific Pvt Ltd will provide technical consulting in addition to a wide breadth of comprehensive sample management capabilities. Huang will be responsible for overseeing and managing the operations in Asia, identifying and developing new services and driving overall business development and services growth in the region.

Anthem Group enables secure remote access for employees ANTHEM Group, recently declared the implementation of Citrix® server and desktop virtualisation solutions, resulting in secured remote access and boosted productivity for employees in addition to enhanced business continuity. Being a start-up on a

fast track growth path, the company could not afford to have n+1 concepts and wanted to avoid the challenging and cumbersome process of traditional desktops by provisioning them with the requisite user applications. The company also wanted

Piramal Healthcare’s cancer drug P276 moves to Phase II PIRAMAL Healthcare Ltd has recently received approval from the Drug Controller General of India (DCGI) for conducting the Phase II clinical trial of P276 in combination with chemoradiation for the reduction of serious radiationinduced mucositis in patients of head and neck cancer. Phase I studies were completed in Canada and India. The drug is likely to reach Phase III in early 2013. Dr Piramal Dr Alan Hatfield, Executive VP Clinical Research, Piramal Healthcare said, “The DCGI decision to allow us to proceed with this study in collaboration with many expert investigators throughout India will be of great benefit to patients of head and neck cancer.” Dr Swati Piramal, Vice Chairperson, Piramal Healthcare, stated, “Severe radiation-induced mucositis is a debilitating toxicity of chemoradiation in head and neck cancer patients and can limit the dosing and frequency. By developing P276 for the treatment of radiationinduced mucositis, we hope to provide benefit to patients clinically, and in terms of a better quality of life, thereby addressing this unmet medical need.”

Court overturns Sandoz verdict THE Alabama Supreme Court overturned a $ 78.4 million verdict the state won against German drug manufacturer Sandoz Inc, ruling there was no evidence to support allegations that the company defrauded the Alabama Medicaid Agency. The justices ruled 7-1 in an unsigned opinion that the case should not even have made it to jurors, much less resulted in a verdict against the company.

to enforce a remote working policy for its employees while ensuring secure data access and constant uptime. To meet these business imperatives, the company opted for Citrix® XenServer™ and Citrix XenDesktop® solutions. Commenting on the

deployment, Ravi Kalla, Senior Manager – IT, Anthem Group, said, “Desktop and server virtualisation are invaluable technologies to address spiraling costs of IT infrastructure. After a careful market assessment, we decided to deploy Citrix technologies,

which aligned perfectly to our business needs. Through a highly cost effective, quick and simple implementation process, today we can enable optimal employee uptime and flexibility to work from anywhere, through secure remote data access.”

Mod er n P har m a•1 - 15 A ugus t 2 012

News, Views & Analysis

AP Pollution Control Board directs 12 pharma units to shut down THE Andhra Pradesh Pollution Control Board has ordered closure of 12 manufacturing units of different pharma companies, including Aurobindo Pharma, around the city for allegedly violating pollution norms. According to a Board’s release, the notices have been issued to the facilities to stop all industrial activities with effect from July 23 to complete the on-going batches. The AP Pollution Control Board has reviewed certain Bulk Drug

industries before the Board’s Task Force committee meeting on July 9, 2012. After detailed discussions, the Board is of the firm opinion that certain

industries are violating the orders of Supreme Court of India, ban notification issued by the Government of Andhra Pradesh, Appellate Authority order and directions issued by the board from time to time. The facilities named in the order include two facilities of Aurobindo Pharma, four facilities of Hetero Labs, one each of Cirex Pharmaceuticals, Covalent Laboratories, Divis Pharmaceuticals, Sri Krishna Pharmaceuticals and Innogent Laboratories and SMS Pharma.

Novartis gains FDA approval for Afinitor® THE US FDA has approved Afinitor® tablets for the treatment of post-menopausal women with advanced HR+ breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole-based clinical trials conducted in 724 women.

“Afinitor is the first and only treatment that boosts the effectiveness of endocrine therapy, significantly extending the time women with advanced breast cancer live without tumour progression,” said Gabriel Hortobagyi, MD, Chair of

Breast Medical Oncology, University of Texas MD Anderson Cancer Center. “The approval of Afinitor in advanced breast cancer marks a proud day for the breast cancer community and Novartis,” said Hervé Hoppenot, President, Novartis Oncology.

Aurobindo to launch generic anti-diabetic drug in the US AUROBINDO Pharma, a leading Hyderabad-based drug maker, will be launching a generic anti-diabetic drug metformin hydrochloride extended-release tablets in 500 and 750 mg strengths in the US markets following final approval from the US FDA. Metformin hydrochloride is a generic version of Bristol Myers Squibb’s Glucophage XR brand that is used to improve glycemic control in patients suffering from type-2 diabetes and has annual sales of around $ 230 million. The company also said that the product will be made in Hyderabad and exported to the US. The company’s Hyderabad plant had been slapped with an import ban by USFDA last year after an inspection revealed that the plant’s facilities were not up to the mark but the ban has been lifted now. Following USFDA’s inspection of the unit in March this year, the

company has recently started getting the US drug regulator’s approvals for drugs such as blood thinner clopidogrel and psychiatric drug quetiapine. Currently, Aurobindo’s other banned unit VI, which makes cephalosporin-based drugs, is awaiting the clearance from USFDA. With the approval of metformin hydrochloride, Aurobindo Pharma now has a total of 153 ANDA approvals from USFDA, including 127 final approvals and 26 tentative approvals.

EMA accepts Pfizer’s regulatory submission to review the MAA application PFIZER Inc has announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated oestrogens (BZA/CE), a potential new medicine for post-menopausal women with a uterus for the treatment of oestrogen deficiency symptoms and treatment of osteoporosis in women at risk of fracture. BZA/CE pairs the Selective Oestrogen Receptor Modulator (SERM) bazedoxifene with conjugated oestrogens. BZA/CE has been studied in a Phase III clinical development programme (Selective oestrogens, Menopause And Response to Therapy [SMART] trials), which included approximately 7,500 post-menopausal women and assessed the safety and efficacy of BZA/CE for the treatment of oestrogen deficiency symptoms, such as moderate-to-severe hot flashes and vulvar and vaginal atrophy, as well as post- The most common menopausal adverse drug osteoporosis. reactions observed The most common adverse in the SMART trials were abdominal drug reactions pain, vaginal yeast observed in the infection and muscle SMART trials were abdominal spasms. pain, vaginal yeast infection and muscle spasms. “We are pleased to be one step closer to potentially bringing bazedoxifene/conjugated oestrogens to women to help manage symptoms of menopause,” said Steve Romano, Senior VP - Head of the Medicines Development Group, Pfizer’s Primary Care Business Unit. Adding to this, he said, “This milestone is a further example of the company’s commitment to advance treatments that may help improve health and well-being at each stage of life.”

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Orchid Chemicals stake upped by Serum Institute SERUM Institute of India Ltd raised stake in Orchid Chemicals and Pharmaceuticals Ltd by buying ` 10 lakh shares through NSE bulk deal transaction. The shares were bought at a price of ` 127.10 per share. which amounted to a purchase worth ` 12.7 crore. Serum Institute already held 4.97 per cent stake in the company as a single entity and along with PACs it held 11.58 per cent as on June 2012 and the new purchase raised

its individual stake by 1.42 to 6.39 per cent. In December last year it had raised its stake by buying 9.13 lakh shares amounting to ` 11.6 crore through bulk deals. Further, other major stakeholders in the company include Citibank NA New York (4.58 per cent), Macquaire Bank (2.17 per cent), Chakan Investment (1.55 per cent) and Barclays Capital Mauritius (1.13 per cent) among others. Orchid Chemicals has lined up a capex of ` 200 crore this fiscal.

Merus Labs International Inc announces acquisition of Emselex®/Enablex® MERUS Labs International Inc announce that it has acquired from Novartis Pharma AG (‘Novartis’) the Canadian and European rights (excluding France, Spain and Italy) to manufacture, market, and sell the branded prescription medicine product Emselex®/Enablex® (darifenacin) extended release tablets. The company funded the Emselex®/Enablex®

Janssen requests approval of Simponi for treatment of UC JANSSEN Biotech, Inc and Janssen Biologics BV announced the submission of a supplemental Biologics License Application (sBLA) to the USFDA and a Type II Variation to the European Medicines Agency (EMA) requesting approval of Simponi® (golimumab) for the treatment of adult patients with moderately to severely active Ulcerative Colitis (UC) who have had an inadequate response to conventional therapy. Approximately 700,000 people in the US and 1.1 million people in the Europe are affected by UC, a chronic inflammatory bowel disease marked by inflammation and ulceration of the colonic mucosa, or innermost lining. “We are pleased to bring forward submissions for Simponi as a potential therapeutic option for patients who fail to respond to conventional treatments and who face continued debilitating effects of living with UC and in some circumstances, a decision of surgery,” said Jerome A Boscia, MD, VP - Head of Immunology Development, Janssen Research & Development, LLC. Adding to this he said, “We look forward to collaborating with the health authorities on these submissions seeking approval of Simponi as a subcutaneously administered anti-tumour necrosis factor-alpha treatment for moderately to severely active UC.”

AMRI India receives Silver Shield Award from Abbott Health Care Pvt Ltd AMRI recently announced that its subsidiary, India Pvt Ltd has been recognised by Abbott Health Care Pvt Ltd for the reliable supply of generic medications for the period from April 2011 to March 2012. This is the second year in a row that AMRI received the Silver Shield award in the category of ‘Strategic Partner,’ which recognises AMRI’s attention to communication, business continuity, quality, flexible pricing and in-time dispatches.

acquisition with cash on hand and a debt facility provided to Merus by PDL BioPharma, Inc a company supporting the healthcare industry with creative financing solutions. Merus acquired the Emselex®/Enablex trademark and patent, certain related IP, and other information and materials required to continue marketing the brand in the territories acquired.

Max completes data management/ EDC services in 60 countries MAX Neeman International recently announced that they have provided data management services to over 60 countries and have completed 250 medical writing projects; key milestones for the company since it began operations in 2001. Outsourcing of clinical research services, such as data management/ EDC and medical writing, continues to grow as sponsors seek quality, reliable results that are more costeffective. Max Neeman has an exceptional talent pool of more than 110 ICH GCP trained professionals in data management and medical writing, having domain expertise and 5-10 years of experience. Koteshwar Govind, Head Clinical Data Management, Max Neeman International, said, “Reaching over 60 countries with our data management, biostatistical and CDISC solutions is very fulfilling and a testament to the company’s customer-driven, customised approach. Independent of whether we run the trial or not, we can

provide exemplary data management services that every clinical research trial needs. Solutions delivered are regulatory-compliant, secure and cost effective.”

Outsourcing of clinical research services, continues to grow as sponsors seek quality, reliable results that are more cost-effective.

The data warehousing facility adds value and renders maximum usability to the existing and legacy data. In addition to providing data management services on Ph I-IV drug and medical device trials, Max Neeman International has been a trusted partner of numerous global pharmaceutical, biotech and device companies for medical writing services.

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In Brief AstraZeneca to initiate study of BRILINTA in patients with PAD ASTRAZENECA recently announced plans to conduct the EUCLID study, a global clinical trial involving 11,500 patients with Peripheral Artery Disease (PAD), a condition affecting approximately 27 million people in Europe and North America. PAD patients are at high risk of Myocardial Infarction (MI), strokes, and other health complications. EUCLID is designed to evaluate cardiovascular event rate and safety in PAD patients. Ticagrelor is currently not approved for the treatment of patients with PAD.

Boehringer Ingelheim pursuing healthcare innovation IN future, patients with certain diseases, especially chronic ones, should be treated in a more holistic approach beyond drug treatment only. Thus, Boehringer Ingelheim is concentrating on new business models and healthcare innovation and just signed a contract with the US company Healthrageous, Inc, a digital health management company. Both companies will evaluate in a pilot study a lifestyle behaviour modification programme to improve the health status of people with diabetes Type 2.

Abbott reports strong second quarter results ABBOTT recently announced financial results for the second quarter ended June 30, 2012. Diluted earnings per share, excluding specified items, were $ 1.23, reflecting 9.8 per cent growth, exceeding Abbott’s guidance range. Diluted earnings per share under Generally Accepted Accounting Principles (GAAP) were $ 1.08, including specified items. Excluding foreign exchange, worldwide sales increased 6.7 per cent. Reported sales increased 2 per cent, including an unfavourable 4.7 per cent effect of foreign exchange.

Drug fails to curb heart bypass complications, but surgery gets safer A drug designed to shield the heart from injury during bypass surgery failed to reduce deaths, strokes and other serious events among patients at high risk of complications, according to a large, prospective study lead by researchers at Duke University Medical Center. But the international study also produced a surprising silver lining. As reported in the July 11 issue of the Journal of the American Medical Association, the researchers discovered that complications among bypass surgery patients were far less frequent than previously reported.

Novartis second quarter results enhance future growth prospects GROUP net sales reached $ 14.3 billion in the second quarter, with growth from recently launched products more than offsetting the loss associated with the Diovan patent expiration. Currency had a negative impact of 5 per cent points as a result of the strengthening of the dollar against most major currencies. Products launched since 2007, which include Lucentis, Gilenya, Afinitor, Tasigna and Galvus, continued to perform strongly. These recently launched products grew 8 per cent to $ 4.1 billion and now comprise 29 per cent of Group net sales, up from 25 per cent a year ago.

HealthWarehouse.com offers the lowest price on FDA-approved generic Lipitor® HEALTHWAREHOUSE.COM, Inc, a leading VIPPS-accredited online retail mail-order pharmacy offers consumers the lowest price of generic Lipitor® in the US. HealthWarehouse has been selling a generic version of Lipitor® since November 30, 2011. Since May 31, customers have been able to order atorvastatin at an even greater discount to retail pharmacies without the need for any coupons, discount cards, or insurance. Generic Lipitor® is available at HealthWarehouse for $ 14 for the 10 mg dose and $ 16 for the 20 mg, 40 mg and 80 mg strength. After conducting local research, the company found that these prices are up to 92 per cent less than competitive retail pharmacies.

The Franklin Institute receives $ 2.5 million gift from Teva THE Franklin Institute has recently received a $ 2.5 million contribution from leading global pharma company Teva Pharmaceuticals in order to develop an innovative exhibit at the museum exploring neuroscience and the human brain, entitled Your Brain. This contribution brings The Franklin Institute’s Inspire Science fundraising campaign total to $ 65 million. “Teva has long been committed to improving science education, and we are thrilled to partner with The Franklin Institute to present

this fascinating new exhibit, which will enable visitors of all ages to explore and understand one of the frontiers

of science research,” said William Marth, President and CEO, Teva Americas. “We are tremendously grateful for Teva’s outstanding generosity and support of the Institute’s mission to inspire a passion for learning about science,” said Dr Dennis M Wint, President and CEO, The Franklin Institute. “Through this partnership, Teva will help the Institute ensure that the scientists, medical professionals, and leaders of tomorrow will be inspired and excited to pursue their potential.”

Sanofi Pasteur’s dengue vaccine demonstrates proof of efficacy SANOFI Pasteur, the vaccines division of Sanofi, recently announced that its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, a threat to almost 3 billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety. The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of the four virus serotypes circulating in Thailand.

Analyses are ongoing to understand the lack of protection for the fourth serotype in the particular epidemiological context of Thailand. “Results of this first efficacy trial with Sanofi Pasteur’s

dengue vaccine candidate represent a key milestone in the quest to develop a safe and efficacious human vaccine against dengue,” said Michel De Wilde, Executive VP, Research & Development, Sanofi Pasteur. “This is also an important development for global public health, since there is currently no specific treatment or prevention for dengue. We are fully committed to making dengue a vaccine preventable disease by bringing a safe and effective vaccine to people.”

SRI wins NIAID grant for topical microbicide gel development SRI International has received a new grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a topical microbicide gel for drug delivery. The topical microbicide gel, which will be based on a patented bioadhesive polymeric platform, is a combination therapy against Human Immunodeficiency Virus

(HIV) and herpes simplex virus type 2 (HSV-2) infections in women. As part of the grant, SRI’s researchers will test a prototype bioadhesive formulation for sustained delivery of the antiviral drugs tenofovir and acyclovir to the vaginal surface. The awarded grant is for two years with a possible extension of three additional years Gita Shankar,

R&D Director, SRI Biosciences Formulations, said, “The easyto-use combination therapy in development could help contain the spread of HIV and HSV, and possibly other sexually transmitted diseases. One of the strongest benefits of a topical gel formula is that it can offer protection when options such as condoms are unavailable or unacceptable.”

Single vial Taxedol now in India VENUS Remedies Ltd has introduced a nanotechnology-based ready to use single vial Docetaxel in India under the brand name Taxedol. Dr Mufti Suhail Sayeed, VP - VMRC, Venus Remedies Ltd, commented, “Taxedol is ready to use single vial formulation. Our one-vial formulation is having the advantage of requiring a single dilution step in suitable Dr Sayeed infusion solutions prior to administration. Thus, offering cost effective solution to patients.” Taxedol has lesser impurities and the administration is easier because of the premix

solution. Furthermore, the nano scale size of the formulation results in improved penetration, higher efficacy, improved safety and lesser side effects. The Docetaxel in nano particle form has 11 per cent higher cancer cell killing potential. “Taxedol will not only weed out the competition from other players in the market but is hopeful of capturing significant share in ` 1,500 crore Indian Cancer Drug Industry, which is speculated to show a steady growth over the coming few years”, said Dheeraj Aggarwal, CFO, Venus Remedies.

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In Brief Sanofi Pasteur begins shipping Fluzone® Influenza virus vaccine in US SANOFI Pasteur, the vaccines division of Sanofi, has said that the first lots of Fluzone vaccine began shipping to US health care providers following FDA licensure of the 2012-2013 formulation. This initial shipment represents the first of more than 60 million doses of seasonal influenza vaccine the company plans to deliver to healthcare providers in the US this influenza season.

Fitch cuts Bristol-Myers Squibb ratings FITCH Ratings has downgraded Bristol-Myers Squibb Co’s long-term Issuer Default Rating (IDR) to ‘A’ from ‘A+’. Simultaneously, the ‘F1’ Short-term IDR and commercial paper rating have been affirmed. Fitch has also downgraded the following ratings for Bristol Myers Squibb Senior unsecured debt rating to ‘A’ from ‘A+’; bank loan rating to ‘A’ from ‘A+’. The ratings apply to the approximately $ 4.8 billion of debt.

AstraZeneca starts new study of heart drug versus rival ASTRAZENECA is to conduct a new global clinical trial of key new heart drug Brilinta involving 11,500 patients with peripheral artery disease. Peripheral artery disease affects around 27 million people in Europe and North America, with sufferers at high risk of heart attacks, strokes and other complications. The new study will compare AstraZeneca’s medicine, currently only approved for patients with Acute Coronary Syndromes (ACS), against older rival Plavix.

Second new diet pill meets high FDA hurdles for approval US drug regulators recently approved Vivus Inc’s obesity drug, the second new diet pill approved in the last month, as health advocates push for new solutions to combat obesity. Approval for the pill, to be sold under the brand name Qsymia, follows last month’s go-ahead for Arena Pharmaceuticals’ Belviq, but the approvals come after a 13-year dry spell for long-term weight loss drugs due to safety problems with past medicines.

J&J hit by strong dollar, CEO eyes pruning units JOHNSON & Johnson (J&J) reported lower-thanexpected quarterly sales and cut its full-year 2012 profit forecast due to the stronger dollar as its new Chief Executive vowed to be disciplined in paring slow-growing businesses. The diversified healthcare company in April had raised its full-year 2012 profit forecast by about 2 cents per share in the face of a weakening dollar, which raises the value of sales in overseas markets. A stronger dollar is especially punishing to companies like J&J that derive most sales outside the US. But J&J recently switched gears and trimmed its full-year forecast by 7 to 10 cents per share, citing a turnaround in the dollar’s direction. It now expects $ 5 to $ 5.07 per share, little different from its earnings-per-share profit last year of $ 5.

Baxter Alzheimer’s drug keeps four patients stable for 3 years FOUR Alzheimer’s patients treated with an immune system therapy have seen their disease stabilise for at least 3 years, raising hope that the drug from Baxter International Inc will prove effective in larger trials. Scientists say the study is too small to show whether the drug will ultimately prove effective, but any sign of progress in Alzheimer’s research is welcome. Scientists expect Baxter’s results next year.

Cadila’s stock rising among Indian pharmas – Credit Suisse CREDIT Suisse initiated coverage on Cadila Healthcare (CADI.NS) with an ‘outperform’ rating and a target price of ` 970. Investment bank says the midcap drug maker has demonstrated ‘strong execution’ in the US, with a portfolio mix focussing on low competition products such as nasal sprays and injectable drugs.

Himalaya’s Liv.52® enters the Limca Book of Records THE Himalaya Drug Company’s Liv.52®, a phytopharmaceutical formulation for the management of liver disorders, will feature in the Limca Book of Records: Business Edition (2013) as the highest selling herbal drug in India, both in terms of units and rupee value. Since its launch in 1955, Liv.52® has become the country’s top hepatoprotective. “Currently a ` 150 crore brand, it is the only herbal drug to feature in the top ten of the bestselling drugs in India, according a report by Indian Pharmaceutical Market (IPM),” said Philipe Haydon, CEO— Pharmaceutical Division, The Himalaya Drug Company.

Haydon

Haydon elaborated, “Like all our pharmaceutical products, Liv.52® is also promoted ethically through doctor prescription. Currently, over 400,000 (4 lakh) doctors across the globe prescribe Himalaya’s products.”

On receiving the certificate from the Limca Book of Records, Haydon added “Liv.52® has been our flagship brand since 1955 and we are thrilled with this honour. The success of Liv.52® tells us that today herbal medicine is gaining global acceptance and when combined with allopathic therapies, it can vastly improve patients’ quality of life.” Limca Book of Records, launched in 1990, emphasizes on unique achievements of Indians and Indian companies within the country and abroad. Records are divided into multiple categories, which include music, entertainment, human story, radio and cinema.

PHFI, DMDEA and MSD India in pact PUBLIC Health Foundation of India (PHFI) and Dr Mohan’s Diabetes Education Academy (DMDEA) announced the launch and expansion of CCEBDM (Certificate Course in Evidence-Based Diabetes Management) to develop core skills and competencies in primary care physicians for the practice of evidence based diabetes management, focused on the management of Type 2 diabetes. An educational grant for this initiative has been provided by MSD Pharmaceuticals Pvt Ltd (MSD India). The aim of the programme,is to impart on-job training to the primary care physicians

on the latest advances in the field of diabetes management. The course curriculum is divided into twelve modules spread over 12 months under which physicians are trained by regional faculty identified by the program organisers. According to Dr K Srinath Reddy, President, PHFI and Chair of Planning Commission’s High Level Expert Group on Universal Health Coverage, “It is our endeavour to help strengthen education, training and research in the area of public health. CCEBDM is a multistakeholder initiative in partnership with MSD India and Dr Mohan’s Diabetes

Education. We believe that primary care diabetes physicians are going to play a major role in the evolution of the care of diabetes in years to come. Realising the ever expanding number of diabetics in India this is very difficult in view of the relatively small number of diabetologists/ endocrinologists; this vacuum needs to be filled in by trained physicians. We have already reached out to a vast number of doctors who have benefited through this and we intend to reach out to more doctors in the future, which is ambitiously larger than the previous cycles.”

CSD, IntrinsiQ unveil integrated data solution CEGEDIM Strategic Data (CSD) and IntrinsiQ have formed partnership with the launch of an integrated solution for monitoring promotional activity and its impact on oncology drug utilisation in the US market. The integrated oncology data solution will provide promotional

spending combined with actual drug usage data across a significant sample of US oncologists. The technology will allow pharmaceutical marketers to utilise treatment data in conjunction with a co-ordinated set of marketing data and help customers to overcome the challenges that they would face from manually

combining data from multiple vendors. IntrinsiQ has become the marketing partner for CSD’s enhanced oncology data set in the US with the announcement of their integrated solution. The data set can be accessed both from IntrinsiQ’s existing customer data portal or through CSD’s analyser lightweight BI tool.

Chugai Pharma opens $ 158 million antibody lab in Singapore TOKYO-BASED Chugai Pharmaceutical Co Ltd recently opened a new laboratory in Singapore that will conduct research into new antibody drugs. The Singapore-based Chugai Pharmabody Research Pvt Ltd (CPR) will screen antibody drug candidates for therapeutic potential using Chugai’s proprietary antibody engineering technologies.

The new facility will be located at Singapore’s Biopolis R&D hub and employ approximately 60 researchers. A*STAR Chief Scientist David Lane is the chairman of the board of the venture. Chugai is expected to invest $ 158 million into the lab over five years as it aims to generate five or more drug candidates per year for its drug pipeline. It will make use of its proprietary

recycling antibody technology, which uses a single antibody molecule to repeatedly block the function of the target antigen and eliminate it from plasma. CPR will be Chugai’s fourth satellite research institute following its C&C Research Laboratories in South Korea; Pharmalogicals Research Pvt Ltd in Singapore; and Forerunner Pharma Research Co Ltd in Tokyo.

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More than 150 antiretroviral drugs available for HIV/AIDS relief US FDA has approved a total of 152 antiretroviral drugs in association with the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic. The most recent tentative approvals were of the generic drugs abacavir oral solution, lopinavir and ritonavir oral solution and efavirenz tablets. Margaret A Hamburg, US FDA Commissioner, said, “Thanks to the hard work and commitment of hundreds of FDA staff and our partners, we now have safe and effective antiretroviral drugs that are widely available at

low cost and in forms that allow for better adherence. Together, we are changing the course of the AIDS epidemic.” The antiretroviral drug products either fully or tentatively approved by the FDA under PEPFAR include innovative formulations such as fixed-dose combination and co-packaged products that can be used alone as complete regimens or in combination with other antiretroviral drugs. The products also include tablets for adults, as well as tablet formulations that can be dispersed in water for children who are unable to swallow tablets, making it easier for infected individuals to take and adhere to their medications.

Medikly launches KONNECT analytics platform MEDIKLY has launched a cloud-based, new engagement and analytics platform, KONNECT, for pharmaceutical brand teams and marketing agencies. KONNECT provides datavisualisation, advanced analytic

capabilities, tools, knowledge, and expertise to deliver targeted and personalised brand experiences. Medikly Nita Nehru, VP- Business Development and Channel Partnership, Medikly, said, “With KONNECT, creating,

Nuvo to receive $ 6 million payments from Pliaglis® EU NUVO Research Inc, a speciality pharma company dedicated to building a portfolio of products for the topical treatment of pain recently announced that Galderma SA (Galderma), a global company dedicated to dermatology has received its first three Pliaglis marketing licenses from EU countries. These licenses entitle Nuvo to receive a total of $ 6 million of milestone payments from its worldwide Pliaglis marketing partner, Galderma. The milestone payments are due on the earlier of the launch of Pliaglis in the approved countries or 6 months from the date of marketing approval. “We are extremely pleased that Pliaglis is in the process of being approved in a number of EU countries and that Nuvo is receiving a substantial regulatory milestone payment as a result,” said Dr Bradley Galer, President, Nuvo’s Pain Group. The upcoming launch of Pliaglis will mean that Nuvo will have three growing sources of revenue from globally commercialised topical pain products.

FDA-clears Asthmapolis solution ASTHMAPOLIS partnered with Synapse to develop breakthrough technologies for asthma treatment. Combining medication sensors, mobile applications, and analytics, the Asthmapolis sensor attaches to existing rescue inhalers to collect data such as when and where patients experience asthma conditions. “Asthmapolis was a unique and challenging product for Synapse,” said Dylan Garrett, Director - Business Development, Synapse’s San Francisco office. “For people with asthma, an inhaler is a device they rely on regularly and, in many ways, have a personal relationship with. Beside the issues of complex functionality and small form-factor, there were numerous human factors issues that had to be resolved.”

managing and monitoring physician engagement through one central hub costs as little as $ 10 per physician, as it is offered via the cloud and available through a subscription-based pricing plan.”

In Brief Venus gets US patent for Potentox VENUS Remedies Ltd recently announced that it has got US patent for Potentox, used for pneumonia other infections and is looking at increasing presence in the $ 12 billion antibiotic market in America. Granted by US Patent and Trademark Office, this is the third patent which the Panchkula-based company has received. The patent provides an exclusivity period till May 2027.

Danone completes acquisition of Wockhardt Group’s nutrition business DANONE recently announced the completion of its acquisition of Wockhardt Group’s nutrition business. With the completion of the deal, Danone has now formally entered India’s baby food and medical nutrition market, with Dexolac, Farex, Nusobee and Protinex brands, respectively. The new entity has been named Nutricia International Pvt Ltd.

Granules India net profit up 100 per cent GRANULES India Ltd recently announced its financial results for its fiscal year 2013 first quarter ended June 30, 2012. Granules consolidated net sales increased 59 per cent to `189 crore while consolidated net profit increased 100 per cent to ` 6 crore. Sales increased due to accelerating growth from all three divisions.

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In Brief Parexel and KDDF form alliance PAREXEL recently is the first CRO chosen by the Korea Drug Development Fund (KDDF) to help Korean companies develop and commercialise healthcare products for the global market. KDDF was established in September 2011 with assets of $1 billion to develop at least 10 new drugs by 2019. Its alliance with Parexel enhances its development network and will provide access to a broad range of drug development support services for its selected investments.

FDA approves Ferring’s PREPOPIK™ THE USFDA granted Ferring Pharmaceuticals Inc approval to market Prepopik (sodium picosulfate, magnesium oxide and anhydrous citric acid) for oral solution indicated for cleansing of the colon as a preparation for colonoscopy in adults. Prepopik is a low-volume, orange-flavoured, dual acting, stimulant and osmotic laxative.

Golden West Biologicals introduces Seratrol™ Vitamin D GOLDEN West Biologicals, Inc (GWB) has introduced Seratrol Vitamin D-free human serum for use as reference material in the development of assays and calibrators. “It is important for in vitro diagnostic device manufacturers to deliver properly calibrated Vitamin D assays,” said Tammy Guenthner, Manufacturing Manager, GWB. “Seratrol product line has been developed to consistently match the human serum matrix as closely as possible, which leads to reliable Vitamin D values.”

Patients ignore warning labels on drugs: Study PATIENTS seem to ignore prescription drug warning labels with instructions that are critical for safe and effective use says a study conducted by Nora Bello, an assistant professor of statistics at Kansas State University along with scientists at Michigan State University. “These findings have implications for the design of prescription drug warning labels to improve their effectiveness, particularly as the US government recently started to investigate approaches to standardise the format and

content of these labels to decrease medication error rates,” Bello said. “Results from this study can provide insight to assist debates about labelling designs that are most likely to impact a wide age range of consumers.” The findings show that older patients do not always pay attention to drug warning labels and this is worrisome because they are reportedly at a greater risk for dangerous medication errors given their usually more complicated drug regimes. Researchers tracked study participants’ eye movements

over labels on a prescription drug vial to measure attention. As per the study, 50 per cent of participants older than 50 years of age failed to notice the warning label and 22 per cent of these participants’ vision did not enter the warning label area in any of the five vials. In contrast, 90 per cent of young adults between ages 20 and 29 fixated on the warning labels. This difference was partially attributed to the age-specific dynamic of visual fixation of information between the age groups, researchers said.

Torrent Pharma appoint Directors TORRENT Pharmaceuticals Ltd has inn its AGM said that Shashikant Bhojani has ceased to be a Director of the company due to his retirement from the board with effect from the conclusion of

AGM. Dr Leena Srivastava (who was earlier appointed as Additional Director by the Board of Directors at its meeting held on October 18, 2011) has been appointed as Director (Independent Non-

Executive) of the company, liable to retire by rotation; and Haigreve Khaitan, who was earlier appointed as Additional Director has been appointed as Director of the company liable to retire by rotation.

Onyx receives FDA approval of Kyprolis™ ONYX Pharmaceuticals, Inc recently announced that the USFDA has granted accelerated approval of Kyprolis™ (carfilzomib) for injection, a proteasome inhibitor, indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. “Today’s approval is a significant milestone for Onyx and, most importantly, for patients with advanced myeloma who have few treatment options available to them,” said N Anthony Coles, MD, President and CEO, Onyx Pharmaceuticals.

Quintiles, Allscripts to develop software solutions for clinical research QUINTILES and Allscripts have partnered to jointly develop software solutions for clinical and post-approval research. The collaboration focuses on late-phase research, recruiting for and monitoring of clinical trials, and postmarket surveillance. The partnership aims The at developing products partnership that overcome aims at obstructions in clinical developing research, outcomes, education and proof of products that new compound safety, overcome effectiveness and value. obstructions Gavin Nichols, VP, in clinical R&D Innovation, IT, research. Quintiles, said, “We believe biopharma, patients, providers and payers all will benefit from the technology solutions that grow from this undertaking.” The new solution will enable customers to leverage de-identified longitudinal data, which could enable companies to improve the efficiency of processes involved in the development and evaluation of new drugs.

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Epigenetics could offer a break through for cancer treatment EPIGENETICS is emerging as a key determinant of cellular differentiation, playing a vital role in a number of human diseases, according to a new report by GBI Research. The new report examines epigenetics, which refers to a selective regulation of gene expression within different cells that does not affect the genomic makeup of the DNA sequence. The last few years have seen a surge in research into epigenetic modification of the chromatin within a cell’s genome. Epigenetic changes appear to regulate differentiation of stem cells as well as giving rise to malignant cells, which include cancerous cells. Given the huge market potential and considerable unmet need, it is not surprising that almost every major pharmaceutical company has an epigenetic programme in oncology. The growing number of cancer patients worldwide offers a lucrative market for epigenetic-based molecules, and the successful launch of just one drug could generate huge revenues. Epigenetic targets are structurally complex, requiring a great deal of work to be characterised, and investigations into innovative drug

SHARP launches Plasmacluster ion air purifiers IT has been the endeavour of Sharp to introduce one-of-a-kind products to the world. Plasmacluster Ion Technology for indoor air treatment is a recent addition. Plasmacluster technology creates forest-fresh environment indoors by generating negative and positive ions, which are created in natural environments like a forest. These ions kill all harmful substances like pollen dust, allergens, virus, mould, gases and foul smell not just from the air

but also from the surface of things kept indoors and thus creating a neutral and fresh environment to breathe easy and safe air. The effectiveness of Sharp’s Plasmacluster Ion air purifiers have been verified by renowned academic and research institutes around the world. It has been certified by the Asthma Society of India and British Allergy Foundation to be most effective in removal of triggers that cause Morning Allergy and Asthma. Sunil K Sinha, Managing Director, Sharp Business Systems (India) Ltd, said, “Sharp Plasmacluster air treatment solution sends out the same positive and negative ions found in nature, that kills the harmful substances from the air as well as the surface of our indoors, thereby creating a fresh indoor environment.” “Products equipped with Plasmacluster technology have crossed more than 3 crore units worldwide. Plasmacluster technology is a blessing for those suffering from respiratory and chronic diseases to give their immune system rest while they are indoors so that they can enjoy when they are outside,” he added.They are priced in the range of `11,990-57,990 and are available through retail outlets across India.

discovery against new targets involve a high level of risk. The toxicity of epigenetic-derived drugs is an important challenge for researchers and investors, as currently marketed epigenetic-based drugs can cause serious adverse effects, and these risks have led to a low uptake of epigenetic therapies in the market. It also remains unknown as to why first-generation epigenetic-based therapies have been successful against haematological cancers in contrast to other types. GBI Research believes that these challenges will not be resolved by a single organisation, but instead demand co-ordinated and collaborative efforts from academia and pharmaceutical companies over time, in order to solve this medical mystery.

Moisture content analysers with halogen heating and drying curve METTLER-TOLEDO India has introduced Excellence HX204 Moisture Analyser. The analyser can be adjusted and calibrated at operating temperature. The built in Level Control sends warning if the instrument is not correctly leveled. It also provides realtime graphics for full process control and integrated control charts monitors trends in moisture content. The halogen heating system provides precise temperature control and it also includes a hanging weighing pan that distances the weighing cell from the heat of the sample chamber. “Industry is looking for the moisture analyser

SmartCal

and regulations ask for the use of analytical balance of resolution of 0.1 mg. It also offers all with the high performance MonoBloc weighing cell, accurate and fast 2nd generation halogen heating. Real time charts for full control and state-of-the-art data management using USB flash drives offers excellent user interface” said Mahesh Sawant,

Product Manager, Mettler-Toledo India. “SmartCal allows a simple 10 minutes test for the verification and documented performance evidence for moisture analyser. LabX is very useful to tool design application as per customer’s method and it executes with just one click on the interactive touch screen.”

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In Conversation With

India is definitely not lacking behind US or any other country and has made a name and space for itself in the global pharmaceutical industry ...declares, Art Caputo, President - Waters Division, Waters Corporation. Here, Caputo talks about the way the Indian pharmaceutical industry has evolved over the years and has made a name for itself in the international market.

Jasleen Kaur Batra jasleen.batra@infomedia18.in

How is the Indian pharmaceutical sector different from that of the US? The pharmaceutical business breaks down into research companies, generic companies, CROs, academics and so on. Thus, the overall pharmaceutical business is highly segmented. What makes India different from the rest of Waters pharmaceutical business is the high percentage of generic business. Today, of the total business in India, 80 per cent of the revenue is generated from the generic market. Traditionally, the US or the UK pharmaceutical industry has been discovery based and generics have not been a significant part of the industry. However, today we are seeing a trend in the US towards generics; the generics market is growing and the outsourcing trends have also begun in most companies. In India, the pharmaceutical market has shifted over the years; initially it started with clinical trials, but now there are discovery activities being done in India and countries such as US and UK are distributing their research and discovery work to various companies in India. A noticeable shifting can be seen; 10 years ago India was known only for generics but today R&D is taking place in India. Also, a number of companies have entered the field of innovating new drugs. Further, India is entering the field of diagnostics over therapeutics - we can be much more successful if we can provide proper diagnostics. I feel this is a trend that has begun and will go a long way. The genomics is also catching up in India but in other areas such as generics, CRO and more, India is doing better than other countries. Thus, today India is definitely not lacking behind US or any other country and has made a name and space for itself in the global pharmaceutical industry. How is the Watersâ&#x20AC;&#x2122; business strategy for India different from that of US or other countries?

The basic strategy is the same in Waters across the globe, which is to try to understand the need of our clients; formulate various products and processes to help the system and so on. However, there are a few variations that are brought keeping in mind the dynamics of each country but these are minor changes. What is best about India is its strong relationship with the higher management levels within the industry. A few regions have the potential of generating high revenues for a particular field than the other, and in such cases a few variations are made in the way the industry and the market is dealt with. This helps evolve the organisational ladder for the ladder of relationship with the influential people and that special bond helps in increasing the business as the information flows better and helps us connect to the right people for the right task. Thus, relationship building is a factor that helps India stand out from the other, but overall the strategy remains the same. India is a price sensitive market. How do you manage to meet the requirements of the country? In a price sensitive market one needs to be a high value-added solutions-based company. Hence, if a company falls into the trap of being price sensitive, they are not likely to be a high value-added company as they would always be competing against price. Also, price fluctuates for a commodity; we are not a commodity but are a high value-added solutionsbased company. For us, success is when we are able to prove the quality and technology of our products. Also, the Indian culture is such that negotiations are always a part of it. So no matter how low we set our prices, there will always be more negotiations. However, we do make slight changes in the price of the product depending on the country. If

the salary or the economical condition of one country is lower than the other, then we do make a few alterations. The value that we provide the company is our focus as we strive to provide support and services, which other companies do not provide. We have a very high market share in India and we ensure that we give them value for their money and a strong after sales support as the cost of the problem is greater than the cost of the solution. What got your interest in working within the analytical space in the pharma industry? While setting up the company we realised that analytics has a lot of potential and can grow in different ways. We also discovered that if we take the time to understand the problems and provide solutions in this space we would soon be in a position to grow our

If a company falls into the trap of being price sensitive, they are not likely to be a high value-added company as they would always be competing against price. business and have strategic acquisitions to complement our goal - to provide high quality products every year. We felt we could achieve our goal by innovating - we felt there were various ways in which we could grow but to double the profit of the company, the company as a whole would need to grow as well. As we have the talent and the technology we choose to offer high returns and growth to our share holders by focussing on analytical industry as we knew the potential of the segment. This is when we focussed and

Quick bites As an Italian he enjoys a good Italian meal more than any other cuisine Likes to go to Vegas and Africa on vacations Has a deep passion for hunting and motorcycling Enjoys a good book, his all time favourite being Heart of Darkness by Joseph Conrad

streamlined our process to ensure that we have the time and space to innovate to work through the next generation technology and requirements. So far, our innovations and products have worked and have been appreciated by the industry. Today, we are a $ 500-million company and are striving to become a $ 1-billion company. The output is easier today as we have got the time to work on our strengths and opportunities. Also, the opportunities have increased today from what they were before; thus, we are in a positive to grow and expand over the coming years and provide better satisfactory results for the pharmaceutical industry. What are the current pharmaceutical trends in India? Pharmaceutical industry has gone through a lot of changes over the years, and I feel today the Indian pharmaceutical scenario is back on track. Today, the cost of finding a new drug is extremely high and the regulatory demands are extremely stringent. Thus, it is clear that the return on capital is not the same as it was before as the investments have increased. This has helped India as they have understood the demands and are today remodeling themselves to be back on track.

Also, the area of biopharmaceutical as well as personalised medicine has a lot of potential and so the market size as well as the opportunities are increasing. Countries such as India, China, Latin America and other have witnessed a significant growth in the number of MNCs coming in along with new startups. Due to this companies are focussed and are producing high quality products to compete in the international market. What are the future plans of expansion within Waters? Expansion is really a continuous process for us. With the exception of a facility we are not always capital intensive. Every year we are expanding in putting up a better portfolio so we continue to retain and use our resources to ensure we grow at a strong profitability. For us, success has been to strive harder every single day. So investment and expansion is linked with the profits and growth of the company. Thus, we have our own labs across India at places such as Mumbai, Delhi, Hyderabad, Bengaluru. Currently, we are in the process of expanding our facility in Bengaluru, which should be ready by next year. We will also be expanding our offices in Ahmedabad and Chandigarh soon.

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Special Focus

CRAMS landscape in India

The key drivers With the revenue generation doubling over the past few years, India is a well-known market for Contract Research and Manufacturing Services (CRAMS) and is expected to grow in the near future. We look at the past and present CRAMS landscape in India along with the key drivers of the industry, and needs of the pharma companies. he Contract Research and Manufacturing Services (CRAMS) market predominantly consists of contract manufacturing of new chemical entities, API, pre-clinical and clinical research. According to reports, drugs over $ 9 billion are expected to go off patent by 2015 and the companies are looking out for costeffective outsourcing solutions to remain unaffected. As per reports, global CRAMS market is estimated at $ 60-70 billion and is expected to grow up to $ 90 billion by 2015. The Indian CRAMS business contributes $ 3.8 billion to this big number and this is estimated to grow till $ 8 billion by 2015. The entire CRAMS market is split into contract research that contributes $ 1.5 billion and rest 60 per cent is contributed by manufacturing services. While the global CRAMS market has grown at 16 per cent CAGR, the Indian market has grown at 32 per cent as per a report by CARE Ratings.

Growth factors and needs of the pharma companies The demand for new drugs and patent cliff is seen as a major driving factor of the contract manufacturing industry. Major

Over the last decade, companies in the CRAMS business are offering complete solutions from discovery, chemistry, preclinical studies, formulations research and contract manufacturing. Vijay Shah Executive Director & COO, Piramal Healthcare Ltd

pharma companies will not be able to sustain and lose billions due to expiry of patent and lack of new approvals. Pharmaceutical companies are going for strategic alliances to maintain revenue and to enhance product pipelines. Pharma industry deals with innovation and the increase in cost of R&D for new chemical entities, raw materials and wage inflation are few additional factors causing pharma companies to look out for outsourcing solutions in Indian markets. The increased demand of generics is also seen as a one of the factors that causes the CRAMS industry to grow. Vijay Shah, Executive Director & COO, Piramal Healthcare Ltd, says, “The maximum research by the main stream India-based pharmaceutical companies is focussed on the development of generics formulations ranging in complexity from simple to complex dosage forms for the US and European markets. The domestic consumption story offers huge advantage for the Indian companies to innovate and introduce incrementally different products and fixed dose combinations for the Indian market to stay competitive.” Pharma companies hunt for US FDA-approved plants, skilled man power and low operating cost while selecting a partner for outsourcing. The contract manufacturers are expected to serve with maximum efficiency and minimal risk. Technology transfer from R&D to commercial scale is also a key component for the success of a contract manufacturer. Confidentiality maintained by the partnering companies also plays a very important role. Vikram Gupta, Founder and Managing Partner, Ivy Cap Ventures Advisors Pvt Ltd, says, “Pharma companies look for knowledge and experience. They also lo ok for partnering with innovators with strong manpower, experience and expertise. Return on Investment (ROI) and cost saving is an important parameter along with the confidentiality maintained in

the proprietary information that is dealt with.”

Indian scenario: Regulations, competition and challenges India offers about 40 per cent low operating cost compared to western Contract Research Organisations (CROs). There has also been drastic change of government policies over the period of time. The patent regime in India introduced during 2005 by Indian Biotechnology Policy simplified procedures for regulatory clearance and exempted import duties and service taxes on the raw material being imported that encouraged multinational pharmaceutical companies to outsource in India. This generous support has greatly nourished the growth of CRAMS in India. However, research analysis suggests that many Eastern Europe countries may offer superior IPR protection compared to their Asian counterparts, and hence, there can be instances of IPR violation. Gupta says, “CRAMS industry has been in India for quite sometime. Despite all the push backs, technological orientation, man power and cost differences has worked in the favour of the Indian industry and provided huge benefits.” India is facing increasing competition from other geographies such as China, Russia, Brazil and Taiwan. China is catching up with the growing CRAMS market. India houses about 100 US FDA-approved plants, twice as compared to China. In China, the State FDA has stated contract manufacturing as a long-term goal for the country’s economic growth. In 2003, the government legalised the Chinese drug manufacturers to conduct contract manufacturing for a pharmaceutical company outside China. Gupta believes, “In India, the regulatory aspects are not matured enough to carry out the processes in a matured manner. The unorganised regulatory procedures cause delay in timelines relative to the other competitive countries.”

Multinationals are gradually also setting up facilities in India. Safety, health and environment are an essential aspect that big pharma’s expect from CMOs and these practices have been developed greatly among Indian companies. Many Indian companies have acquired overseas assets to enhance the scope of their value-added services. Gupta adds, “Indian companies are technologically oriented, and they have a strong man power and provide great cost differential benefits.”

Previous CRAMS collaborations There are four defined models seen in outsourcing: payment or royalty-milestones, co-development model, in-license where they in-license compound from an Indian company and out license wherein global companies outlicense research programmes to an Indian company with a buyback at defined stages of programme. There are certain companies that provide integrated services from discovery to development. Merck outsourced their research activities with Advinus Therapeutics for metabolic disorders; Orchid Pharma for antibacterial compounds; and

Despite all the push backs, technological orientation, man power and cost differences has worked in the favour of the Indian industry and provided huge benefits. Vikram Gupta Founder and Managing Partner, Ivy Cap Ventures Advisors Pvt Ltd

Piramal for oncology drugs. Eli Lily set up their relationship with Piramal, Suven, Zydus Cadila and Jubiliant as a collaborative approach across several therapeutic areas. AstraZeneca initiated their research collaboration with Jubilant in the area of neurological and psychiatric diseases. GVK Bio sciences partnered with Wyeth for their chemistry services and Biocon partnered with Bristol Myers Squibb, Mylan for biosimilars in oncology, Amylin for novel peptides for diabetes treatment and with Vaccinex for mABs and oncology products. Gupta feels, “Focus is very important. The right thing to do is to develop expertise in a particular field. Companies should also develop a strong delivery angel. Standards and mechanism of delivery that companies follow is also important. These will act as a natural affinity for outsourcing.”

How things will change? International giants are expected to change trends and look out for a one-stop solution for integrated services such as drug development, research, clinical trials and manufacturing. Dramatic changes are expected in the future due to increased competition in generic markets, shrinking average patent life and government pressure to reduce drug prices. There is expected to be a demand for CRAMS in the areas of discovery pipeline for biologics, cytotoxic compounds for oncology, pre-clinical studies, clinical studies and biocatalysts. Global pharma companies are shifting their focus from small molecule drugs to macro-compounds, therefore a raising need of outsourcing R&D and manufacturing needs is expected. Shah highlights about the current contract research companies in India, “Over the last few years, a few of the companies have started increasing their focus on the development of biosimilars along with contract research. The segment that has seen emergence over the last decade are the companies in the CRAMS business offering complete solutions from discovery, chemistry, preclinical studies, formulations research and contract manufacturing. ” In the present scenario CRAMS are looking for opportunities for co-development rather than outsourcing agreements but this trend is expected to change in future. Gupta believes, “We might see a gradual shift in the typical contracts. There might not be many longterm contracts but a larger number of short-term contracts between pharma giants and contract manufacturers are expected.”

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Special Focus

Chandreyee Bhaumik chandreyee.bhaumik@infomedia18.in

ndia is a major destination for outsourcing database management in clinical trials worldwide. Low cost of resources required for this activity has contributed largely for this situation. Additionally, due to strong IT infrastructure in India, there is adequate supply of trained manpower to meet the demands of data management. This is also true of global pharmacovigilance outsourcing for which India is again a destination due to its IT infrastructure and availability of medically trained personnel.

Present scenario Discussing the present scenario, Shravanti Bhowmik MD, General ManagerClinical Research, Sun Pharma Advanced Research Company Ltd, says, “The scenario as of now replicates the IT model of business process outsourcing. However, when it comes to research and knowledge process outsourcing, India is way behind. Complex protocols and innovative research ideas are usually generated outside India. According to the June 2012 data on the US administration website, of the 128,726 clinical trials in 178 countries, just 1,961 studies or 1.5 per cent are being done in India, 49 per cent are being carried out in the US, 5.2 per cent in the UK and 2.3 per cent in China.” Elaborating on the scenario, Shruti Pande, Global Clinical Team Lead, Wockhardt Ltd, “Only 15 per cent of the country’s healthcare expenditure comes from the government, about 4 per cent is from social insurance and about 1 per cent from private insurance parties. The remaining 80 per cent is borne by individuals

The biggest way in which this can be tackled is by an increased participation by academia in the clinical research and regulatory process. Shravanti Bhowmik MD, General Manager- Clinical Research, Sun Pharma Advanced Research Company Ltd

Regulatory approvals are lengthened in India due to a rickety authority in place. Due to the existing hurdles, conducting a clinical trial in India has become a challenge for all. Here, experts suggest ways to bring a change. using private services, without insurance coverage. Therefore, the need of enrolling oneself to a clinical trial is not just for a better medical prospect, but sometimes due to desperation to receive treatment free of cost. However, this factor should not be exploited. We must ensure that we do not let our own citizens be used as ‘guinea pigs’ for unethical and unscientific research. There are enough regulations in place, but a culture of strict adherence to them is what we, as Indians, need to imbibe.” Pande adds that safeguarding the interests of our population is paramount. She highlights, “The responsibility lies on everyone, not just on clinical research professionals. Indian government, media, social activists, researchers, medical professionals and citizens at large will have to take up the onus on themselves. The success and ethical grounding of the trial also significantly depends on the assumed responsibility of the clinical investigator. Indian investigators have demonstrated their compliance by virtue of participation in more than 60 global trials; a majority of those trials were FDA or European registration trials, requiring strict compliance with GCP and regulatory guidelines.” She adds that the data have been accepted by foreign regulatory authorities and published in international scientific journals of repute. Further, there is an increased need for inspection and audits of trials in India, and greater emphasis on compliances is required, which will only

come with raised awareness. She says, “There should be indigenous R&D to stimulate Indian patient- centric drug discovery and development. Moreover, awareness should be instilled in the education system in the country to imbibe the culture of conducting scientific and ethical clinical research. Participation in global trials also encourages research directed towards domestic disease conditions. Scientific misconduct needs to be tackled and not ignored.”

Dominant players Clinical trials have significantly reduced in the last 2 years due to delayed decisions on clinical trial permission. Talking further about the scenario, Bhowmik reiterates, “There has been a lot of bad press about the conduct of clinical trials, resulting in every protocol being referred to the New Drugs Advisory Committees (NDAC) irrespective of their complexity or phase, which in turn has made permission time-lines unpredictable.”

timelines. Talking about the challenges Pande believes, “The DCGI in India is not stable since past 1 year, which has changed the complete stability of clinical research in India. With delayed approvals many of the trials are on hold and have forced many CROs to shut down.” She adds, “Although the US FDA gives approval in 30 days, most US trials are delayed because suitable subjects are not available in adequate numbers. The timelines for approval are often unpredictable in India as the Drugs Controller’s office depends on external experts and other government agencies such as the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) for

Hurdles on the way According to Bhowmik, in new drug development, time is of essence, and the prolonged regulatory timelines are now turning out to be a major hurdle. The unpredictability of the process and lack of transparency in decision making is resulting in business moving to countries such as Malaysia, Phillipines, Vietnam, Singapore where there is respect for all parties involved in the clinical trial process, the scientific and ethical review is stringent, but in total conformance to

Indian government, media, social activists, researchers, medical professionals and citizens at large will have to take up the onus on themselves. Shruti Pande Global Clinical Team Lead, Wockhardt Ltd

advice and there are additional permissions required for the import of trial samples and export of blood samples to foreign central laboratories.” She further adds, “The potential for fast recruitment can partly offset the delay in the regulatory approval. Nevertheless, the regulatory situation is a major concern for all pharmaceutical sponsors and CROs, who continue to press for improvements in the regulatory approval process to make it predictable, accountable and less cumbersome.”

Overcoming the obstacles Industry representation is one of the ways. Commenting on the various ways of overcoming hurdles, Bhowmik suggests, “The biggest way in which this can be tackled is by an increased participation by academia in the clinical research and regulatory process, where the academia encourages industry collaboration and partnerships. This is why clinical research is successful in other countries. The parliamentary committee report on CDSCO (May 2012) lists down several steps that need to be taken to overcome current challenges.” Thinking in the same context, Pande shares, “The other aspects of regulatory revisions such as adoption of GCP guidelines, removal of import duty on clinical trial samples, elimination of restrictions on concurrent trials, anticipated patent law changes have shown India’s seriousness about becoming a hub of global clinical trials.” Thus, the plan and time frame to address the challenges facing regulatory scenario will determine the future of clinical research and database management in India.

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Special Focus: Interface

CRAMS in India will grow at 20 per cent per annum Generics are manufactured on specific contract basis. Shibani Shah shibani.shah@infomedia18.in

What makes the Indian CRAMS players a choice for outsourcing by the pharma companies? MNCs choose India as a destination for outsourcing since it is economically affordable. Chemical expertise is available here along with efficient project management skills. Emerging biotech and pharma companies see tremendous value in India. Here, there are two kinds of models prevalent. The full time equivalent model in which the Intellectual Property (IP) belongs to the parent company and the custom synthesised in which the Intellectual IP belongs to the contract manufacturer. Drugs that have gone off patent are outsourced on a large scale in India. Generic drugs have a smaller market as compared to the drugs that have gone off patent and are manufactured on a large scale in India.

What are the parameters that the MNCs consider

while selecting a contract manufacturer? Pharma companies look at the cGMP followed by the manufacturers at the kilo labs.

…says Abhay Kumar, MD, Shashun Pharmaceuticals Ltd. Here, he talks freely about the reasons that make India a hub for contract manufacturing, Shasun NBI, the key drivers and future of the industry.

Their main concern is also the confidentiality maintained by these companies and the analytical expertise that they offer. It also checks if the company is Safety, Health and Environment (SHE) compliant. They look out for manufacturers abiding the USP standards for the outsourcing their products. The manufacturers should be able to deliver better project management skills and communication. It should also have the ability to carry out innovative processes and have technology transfer capabilities. The manufacturers should be able to take a drug from lab scale to commercial scale. These are few qualities that will enable contract manufacturers to have a better alliance. Shasun entered into a joint venture with Nanoparticle Biochem Inc in 2011, what kind of nanoparticles have been developed? The radioactivated gold nanoparticles were first developed at the University of Missouri. We have gone into a JV with them and formed Shasun NBI and we are focussing on taking the drugs used in cancer treatment to clinical

studies. These nanoparticles are greatly used for cancer cure across the globe and it attacks the tumours without affecting healthy tissues. The results in animal studies have been phenomenal and it is a platform technology for curing any solid or malignant tumour. It is a non-invasive process that requires no hospitalisation. It also does not require radiotherapy, chemotherapy or any drugs followed by the treatment. What are the key drivers in contract manufacturing industry? The main drivers for this industry are the affordable prices offered by the contract manufacturers and good regulatory practices followed by them. It is also the analytical capabilities of these companies that will drive the growth. With a large number of drugs going off patent we are expected to see a bigger market. How do you see the future of this industry? CRAMS in India will definitely increase at 20 per cent per annum. By 2020 we are hoping to see triple the revenue of the current level.

There is immense opportunity in terms of outsourcing due to cost pressure, patent cliff, declining R&D productivity, Chandreyee Bhaumik chandreyee.bhaumik@infomedia18.in

Provide an overview of the CRAMS market in India The Contract Research and Manufacturing Services (CRAMS) market in India would cover translational chemistry, contract manufacturing, clinical research, etc. While giving an idea about the CRAMS market in India it is difficult to compare India with the developed countries because the skills of the developed countries are much advanced since they have deeper science base, stronger base for clinical research and other aspects. However, . Additionally, in developed countries there is less number of students graduating as engineers and scientists. Amid this scenario, for the developed countries, India is a great country to work with and thereby leverage on India’s skills. Discuss the advantages and how does India make the best use of these?

I believe that India’s biggest advantage is the supply of scientific talent. And there is no denying the fact that initially people came to India for cost effectiveness. Second, the second advantage is the quality of manpower because there is a large pool of scientific base in India. The areas that need to have focus are new chemical entity research, biosimilar research, and biosimilar manufacturing. Therefore, these would be few of the areas that we need to continue developing on. What are the challenges for the Indian CRAMS market? We must remember that one of the primary challenges is global competition. Other countries such as China and Eastern Europe are all catching up. Sometimes, manpower is also a threat as we do not find the right skill set. Third, in cases like clinical research most of the regulatory approvals have become extremely slow. As a result the situation is delaying inordinately. For clinical research it is required to take due approvals from the Drug Controller General of India (DCGI) at different stages.

cutting down on the delays would be highly appreciable, especially for clinical R&D. We do not lack behind China but in certain areas like pre-clinical research China has an advantage over us.

…believes Sujay Shetty, Partner - Pharma Lifesciences Leader, Pricewaterhouse Coopers (PWC). He shares an overview of the present Indian CRAMS market and its future. The entire process is delayed. No new approval is forth coming in the recent months. This has created long backlog and delays. This ultimately creates a lot of uncertainty,

which is a regulatory challenge. Additionally, we have too many bodies for regulatory approvals. Thus, simplification of regulatory approval processes and

What is the future of this segment? For manufacturing small molecules the future is very bright because generally big pharma companies due to various reasons, whether it is cost, environment or supply of special skills, they have been moving away from manufacturing and choose to outsource it to India. Hence, in contract manufacturing, especially small molecules, the future continues to be bright and lot of work is coming to India. In bio manufacturing it is still early days because the cost differences is not there. But over a course of time even that will develop. And further in clinical trials, there is potential but then it has not yet been fully realised due to delays and other aspects. There is still a lot of potential and we need to meet them.

M od er n P har ma•1 - 15 A u g u s t 2012

22 Insight & Outlook: Automation Trends

ERP systems

Putting operations on track Vadodara-based AMI Lifesciences took control over its management and operational complexities with the help of an Enterprise Resource Planning (ERP) system. ith the vision of becoming one of the leading API manufacturing companies in India, AMI Lifesciences (AMILS) was established in 2004 at Vadodara, Gujarat. Part of the AMI Group, the company was initially named Sunscope Laboratories but was rechristened as AMILS in 2006.

Moving with the times Whether it is to innovate and continually introduce newer products into the domestic and international markets, or to reach out to newer markets and stay effectively connected with its existing clients, the company relies on technology.

The need for technology Owing to its forward-looking strategies and commitment to deliver quality products, AMILS achieved a 30 per cent growth last year. Owing to the growth and expansion in operations, communication between locations and update of information was becoming difficult. Hence, the management decided to deploy a solution that could address the complexities and challenges that growth brings along. AMI management identified the need to deploy a solution that integrated its operations and help bring in efficiencies of scale. The management also wanted access to real-time information flowing across the different departments and locations of the organisation so that the senior officials could take informed decisions, reveals Shivani Trivedi, Head—Finance, AMI Lifesciences. In the absence of an efficient resource management system, the company was experiencing many challenges, mainly related to tracking of highly complex batch production process, establishing control over procurement, tracking materials movement, etc. Hence, began the search for a perfect solution that met the company’s needs. “We evaluated solutions like Tata Consultancy—because we had heard of its reliability. We also thought about developing an in-house Enterprise Resource Planning (ERP) solution. The company wanted software that enabled anywhere and anytime access to all management functions and organisation data. Apart from this, considering the size of the company and the fact that we lacked in-house IT expertise, we concluded that opting for a Software as a Service (SaaS)-based solution was the best way forward. After a careful

Thrust on quality Ever since inception, the company has directed all its efforts towards developing products that match global standards. To achieve this end, it adopts the latest industry best practices. The company is ISO 9001:2000 certified for subscribing to the required, global quality standards. It has also been certified by WHO cGMP for its competent manufacturing practices.

evaluation, we decided to implement the Ramco’s ERP on Cloud solution,” affirms Trivedi.

The switch to ERP It took AMI 6 to 7 months to go live with the ERP solution. “Our major constraint was compiling the data,” says Trivedi. But the Ramco Systems’ team came to the rescue. Parag Nagwekar, Manager – Projects, Ramco Systems, shares more details about the pre-implementation phase, “AMILS needed a system that could capture different quality parameters required by every customer and complied to the Indian taxation requirements, and in addition was simple to work on for users so that their work efficiency is not affected. Hence, we customised the solution after assessing the needs of the company, carefully.”

The new ERP system enables much faster inter-departmental communication and facilitates better solutions to AMILS customers, says Trivedi. “The Ramco ERP on Cloud software caters 85 per cent of our needs. We feel that it will benefit us greatly. We are confident of drawing good ROI from the system,” he adds. Going forward, the company has set for itself a target of achieving 100 crore turnover in the

current financial year. It also developed three new molecules, which it expects will be hailed in the domestic as well as international market. Now, that the company has laid a firm foundation and streamlined all its processes, from here it expects to go from strength to strength, concludes Trivedi, confidently! Courtesy: Ramco Systems

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Special Focus: Roundtable

Should India tax air tickets to pay for AIDS drugs as proposed by the UN? Jasleen Kaur Batra jasleen.batra@infomedia18.in

Dr Arun Bhatt

Ajay Bharadwaj

President, Clininvent Research Pvt Ltd

CEO, Anthem BioSciences India has an infamous history of taxing for various social causes, disasters and the like. There have been education tax, drought relief tax, surcharge for cyclone relief and many more. How much of the collected amount actually reaches the intended is a matter of debate. Without doubt we can say it is poorly administered. Because of this poor implementation record of our authorities, I personally am opposed to creating new taxes/surcharges for AIDS. Today, there is almost always no transparency on how the money is spent in any organisation. Though UN is a well meaning organisation and is one of the most bureaucratic organisations in the world, with high overheads, much of their budget is spent on administration and wages, with a very low trickling down to the needy. It also is a highly politicised organisation with industrialised nations having a disproportionate amount of power to decide the amount to be spent. Once collected, how the money should be spent, is not so much based on need but is an instrument of the Westâ&#x20AC;&#x2122;s foreign policy. There are many other philanthropic and direct intervention NGOs who deliver relief more effectively and they should be chosen. Any effort to share their finances is better than putting an extra tax on air travel. Hence, I am of the opinion that the proposal of taxing air tickets to raise funds for AIDS is not a good idea, as it has a number of loopholes attached to it.

In India, more than 2.4 million people are suffering from AIDS. Considering the number of patients, the UN recently made a proposal to India; introduce air ticket tax to meet the financial requirements of AIDS drugs. Experts contemplate the feasibility of the idea.

This is a way of taxing the poor yet again, and I believe it is not a good manner of doing things. Even if they do tax air tickets, would the money be enough? I doubt it. Also, why is it that every time such organisations try to look for solutions that are out of the centralised health system? The solution needs to come from within the medical industry and so do the funds. You cannot charge the general public for such R&D and purchasing drugs. I feel all these things need to be dealt with in a different way. There is tax for almost everything today, when the public is paying health tax, the government has no business asking them to pay additional tax. Also, assuming that everyone traveling by the air is rich is not a fair notion. The government needs to join hands with research organisations, NGOs and other such organisation to raise money as well as ensure that they get the best of drugs at the cheapest possible rates. Extracting money from the public is not an answer. Also, this is a disease that can be prevented; hence, the government must try to increase awareness instead of spending lakh of rupees in research. Thus, the focus needs to change and so does the solution.

Lakshman P Balajepalli Vice President, RAS Lifesciences Pvt Ltd What the UN has tried to propose is fairly sensible in terms of trying to raise some extra money for AIDS drugs by taxing the flight tickets. My concern, however, is whether the money would go to the right people and would be used for the right cause. In India, money is not a problem as there is a lot of black money, which is being used. We are one of the richest countries in the world, so capital is not the problem. The problem is using the money wisely, for the right purpose in the right way. Hence, the UN must provide a few details to the people in terms of what percentage will be cut from the flight ticket and in which areas would it be used. As the money is being taken out of the pockets of the general public, it is only fair that the entire process is dealt with in a transparent manner. If this policy needs to be implemented, the UN must ensure that the money is used purely for AIDS and nothing else. Also, it is important that the airlines clearly depict the break up to its costumer while they book the air tickets. Today, there are several diseases that require considerable investment in R&D and there is also a similar need to provide cheap drugs for patients of cancer, rare organ disorders, etc. Hence, I feel the UN should also justify why they have decided to propose such a policy only for AIDS and not other life threatening diseases. On the whole, the intention is good, the only problem that needs to be taken care of is that it should be transparent and accurate and detailed information must be available to the public.

Dr N Kumarasamy Chief Medical Officer, YRG Care, Medical Centre, VHS Hospital This proposal has its own pros and cons. I am certain that HIV/ AIDS activists would be thrilled by this proposal, but what about others? That is what the government needs to focus on. Today, the Government of India does not fund as much capital required for research in the field of HIV/AIDS. They need to a lot more money for clinical trials in HIV/AIDS from their R&D funds so that India is capable of producing drugs that we import today. Also, the Government of India has done a lot in the management of HIV-infected patients; today they provide free anti-retroviral medications as well as tests to patients, but they need to go a step further. Most of the investments for HIV/AIDS research come from the US National Institute of Health; hence, the contribution of the Government of India must definitely increase. It is also important for the government to consider the implications of this tax cut on the general public. A person who travels from Bengaluru to Chennai in Rs 4,000 might have to pay Rs 1,000 extra due to this tax. How the general public might adapt to such an announcement is worth observing.

Editorial take The Indian populace is currently burdened with taxes of several forms, and increasing this load on their shoulders may not bode well with them. Alternatively, the Government of India can consider investing in the areas of R&D and clinical research to ensure that India too is in a position to manufacture the required drugs. It is only with such steps that the people suffering from AIDS would be benefitted, and the general public would not be burdened.

Mod er n P har m a•1 - 15 A ugus t 2 012 2

Projects

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. Granules India Ltd Project type: Expansion Project news: Granules India Ltd (Granules) is a leading Contract Manufacturing Organisation (CMO) supplying high volume APIs and Pharmaceutical Formulation Intermediates (PFIs) to the bulk Over-TheCounter (OTC) drugs industry, it also supplies the industry with guaifenesin (ultimately used in cough medications) and metformin (anti-diabetes drug ingredient). Project location: India Project cost: NA Implementation stage: Ongoing

Contact details: Bhaskar Krishna Arumugam, Chief Operating Officer My Home Hub Second Floor Block III Madhapur Cyberabad Hyderabad- 500 081 Tel: +91-40-6676-0000 Hikal Ltd Project type: Finance Project news: Hikal Lte is a mediumsized manufacturer of APIs and intermediates for the pharmaceutical industry and fine chemicals for the agrochemical industry. In order to support its growth, the company is embarking on a capital expenditure programme. The

company has therefore requested IFC to provide a financing package. Project location: India Project cost: NA Implementation stage: Ongoing Contact details: Ashok Moza, Corporate Head EHS Great Eastern Chambers, 6th Floor, Sector 11, C.B.D. Belapur, Navi Mumbai - 400 614 India Tel: + 91-22-27574276 Fax: + 91-22-27574277 Novartis Project type: New facility Project news: Swiss pharmaceutical giant Novartis will invest $ 700 million to build a cell culture production facility in Singapore. This is Novartis’ biggest investment to date in its manufacturing capacity. Project location: Switzerland Project cost: $ 700 million Implementation stage: Ongoing

Contact details: CH-4002 Basel Tel: 41 61 324 11 11 Fax: 41 61 324 80 01 Sanofi-Aventis (Sny) Project type: New facility Project news: French drugmaker SanofiAventis (SNY) has signed an agreement with Chinese authorities to build a vaccine facility in Shenzhen, South China, which will manufacture influenza vaccine. Project location: Shenzhen, South China Project cost: NA Implementation stage: Ongoing Contact details: 174, avenue de France, 75013 PARIS Tel: 33- 1 53 77 40 00 Universite Joseph Fourier Grenoble Project type: Research & Development Project news: Anthracyclines, in particular doxorubicin, are the most effective anticancer drugs. However, their serious side

effect is a cardiotoxicity, which is not entirely understood. We propose a novel hypothesis, namely that anthracyclineinduced cardiac damage. The aim of the project is to verify this hypothesis in different models: perfused heart, cultured cardiomyocytes, and an in vivo model of cardiotoxicity newly established in our group, the doxorubicin-treated rat. This multidisciplinary project will combine biophysical, biochemical, molecular, physiological and systems biology (phosphoproteomics, modeling) state-of-the-art approaches. Project location: France Project cost: 45000 EURO Implementation stage: Ongoing Contact details: Universite Joseph Fourier Grenoble 1Avenue Centrale Domaine Universitaire Grenoble France Tel: +33-476514488 Fax: +33-476635956 Email: service.communication@ ujf-grenoble.fr

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India • Tel: 022 28666134 • Fax: 022 28013817 • Email: parmeet.d@tendersinfo.com

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Mo de rn Ph a rm a •1 -15 Au g u s t 2 012

Event List

N AT I O N A L E V E N T S Annual Pharmacovigilance 2012 The event aims to discuss the latest technologies, methodologies and introducing pharmacy automations on work practices of pharmacovigilance, recent successful strategies and business models to bring out new medicines, keeping abreast of the changes impacting the drug safety industry, etc. Further, there will be discussion on global marketing strategies; August 31, 2012, Hyatt Regency Mumbai For details contact: Virtue Insight Tel: +91 44 64536444 Fax: +91 44 64536443 Email: info@virtueinsight.com Website: www.virtueinsight.com

Automation 2012 All leading companies in industry will showcase their latest products and help one find the solutions at the show. The show brings latest technologies from an interesting array of fields such as: factory automation, process automation and control systems, robotics & drives, field instrumentation & smart sensors bus technologies, software solutions, wireless technology, building automation, and hydraulic & pneumatic automation in renewable energy. From technocrats to solution providers, vendors and tech-buffs, the fair is all set to draw every one alike; September 7-10, 2012, NSE Complex, Mumbai For details contact: IED Communications Pvt Ltd

Tel: +91 22 22079567 Fax: +91 22 22074516 Email: arokiaswamy@ iedcommunications.com Website: www.iedcommunications.com

Pharmac India It is a-three-day event that aims towards highlighting several issues of the industry. This will be large hub of reputed professionals from pharma formulation, herbal products, veterinary drug, medical & disposal, pharma machinery and many other sectors. There will be visitors from pharma company marketing/purchase/ export executive, marketing company & consultant, merchant exporters, contract manufacturers, pharma distributors, generic & OTC manufacturer & wholesalers, Government supplier, liaison agents, sourcing companies, production & purchase professionals, and international business representatives; September 8-10, 2012, Gujarat University Exhibition Hall, Ahmedabad. For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91-22-24102801 Fax: +91-22- 24102805 Email: ramesh.v@orbitexhibitions.com Website: www.orbitzexhibitions.com

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

AHMEDABAD

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Maharashtra, Nov 2-5, 2012

Tamil Nadu, Nov 22-25, 2012

Punjab, Dec 21-24, 2012

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Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

Andhra Pradesh, June 7-10, 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@infomedia18.in

players, maximising revenue, overcoming challenges and achieving growth and revaluating possible development scenarios. Further, there will also be discussions on effective marketing strategies; 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

Indian Lab Automation conference and exhibition ILA 2012 will feature three technical conference tracks; Drug Discovery and Development, Advances in Bioanalysis and Advances in Genomics and Informatics. Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai For details contact: Select Biosciences Ltd Tel: +44 1787 315110 Fax: +44 1787 315111 Email: enquiries@selectbiosciences.com Website: www.selectbiosciences.com

I N T E R N AT I O N A L E V E N T S JCBBB 2012 The 3 rd Journal Conference on Bioscience, Biochemistry and Bioinformatics (JCBBB 2012) aims to provide a forum for researchers, practitioners, and professionals from the industry, academia and government to discourse on research and development, professional practice in bioscience, biochemistry and bioinformatics. This is one of the leading international conferences for presenting novel and fundamental advances in the fields of bioscience, biochemistry and bioinformatics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving bioscience, biochemistry and bioinformatics related techniques; September 1-2, 2012, Phuket, Thailand For details contact: International Journal of Bioscience, Biochemistry and Bioinformatics Tel: +91 422 2611146 Fax: +91 422 2611043 Email: ijbbb@vip.163.com Website: www.ijbbb.org

International Symposium on Pharmaceutical Reference Standards The event aims to discuss current topics and future approaches related to pharma reference standards. Pharmaceutical reference standards are essential for the quality control of

medicines. The symposium will bring together stakeholders involved in the production, characterisation and use of reference standards to exchange their views and opinions on the different issues related to the subject; September 3-4, 2012, EDQM Premises, Strasbourg, France For details contact: EDQM Public Relations Division & Documentation Tel: +33 0 3 88 41 31 50 Fax: +33 0 3 88 41 27 71 Email: beatrice.barth@edqm.eu Website: www.edqm.eu

NCCR 2012 The 6th 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

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

CPhI Worldwide The event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain

For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

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. The four-day 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.

Mod er n P har m a•1 - 15 A ugus t 2 012

Book Review Advanced Aseptic Processing Technology The editors have brilliantly put together a plethora of short chapters from widely respected members of the industry covering in great detail the history, application and wide innovations in aseptic processing with respect to the pharmaceutical industry. The initial couple of chapters describe in brief the history and variety of aseptic processing technology applications in drug manufacture. The editors have compiled detailed chapters on the design of these innovations raging from enclosures, isolators, restricted access barrier systems and others. The use of illustrations, actual photographs, process diagrams aid very well in understanding the flow of the process. The chapters dedicated to quality control, qualification and validation of these processes adds a safety perspective to the topic. There are isolated cases studies discussed that provide a practical view of the complex process. Keeping up with the regulatory landscape, the regulator’s and the regulatory scientist’s perspectives are given dedicated chapters. The book also talks in depth about decontamination of the aseptic processing environments and troubleshooting tips in the same. A fairly technical read incorporating principles of microbiology, disinfection and application of the same to the drug manufacturing process. The book is essential for every scientist, engineer and stakeholder in the drug manufacturing industry.

Editors: Anthony Cartwright, Brian Matthews Price:

` 13,800/-

Publisher: Wiley Publications 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: James Agalloco, James Akers Price:

` 11,500/-

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

International Pharmaceutical Product Registration Registration of a pharmaceutical product at the regulators is a mammoth task for many industry stakeholders. This painful process is made clearer and systematic by this voluminous guide to the process of registration. The book is smartly divided into parts which detail in detail with the different aspects of the registration process. The initial two parts sets the pace with an introduction to the Common Technical Document (CTD) and the overview of its basic contents. The subsequent parts deal in detail the different requirements during the registration process through dedicated chapters. The part elaborating the drug properties in general, brilliantly puts together chapters on chemistry, manufacture, vehicles, composition, processes, quality control, stability and sterility of the formulation. Parts 4 and 5 of the book deal with regulations and documentation with respect to non-clinical and clinical studies performed on the drug in question. The chapters on GCP and fraud in clinical trials are particularly noteworthy. The editors from their wide experience in the field of pharmaceutical regulation have put together a great dossier of regulatory documents, which are a must read for every member of the regulatory affairs team. The book also is a great guideline for the regulators in India for formulating regulatory guidelines in biotechnology and nanomedicines. A must read for every stakeholder who wants to venture into the international landscape.

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

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The goal is regulatory drug and approval to seek adequate tory system, protocols, e solutions to enhance opportuniti sed that subst for all initia infras and then safeguard the drugs With emine patient care. l tructural suppo industry es exist for Indian antial unnec your in India nt Senior in emerg to five seek approval essary steps rt, and remov pharma Director, speakers such ing Russia, within years in process. in the applic al of as Edwa Bosley, Africa and economies like four Packaging United Euro He rd ation pe and Senio States. He assure further that the Pharmaceut r Labelling Technology; Dunn, d that the South America. the highlighted outhouse that the Specialist, William shoul Packaging icals; Prabi Governmenindustry captai ns and d be part of R&D clinical trial r Das, Watson non-tariff t will take Devel opment, Vice Presi board, tax deduc the barriers up InnoP tion by US Mylan, being moun the should benefit of tax 80+ heads ack India as also etc alread dent be after deduction ted Tax EU again y on Minimum of packa 2012 will bring packaging (MAT). st Indian Alternate together R&D from ging devel and will pharma opment and provide - Chandr innovative, manufactur practical eyee Bhaum ik ers, packaging intelligent, integrtake-aways to develo solutions. ated and cost-effectiv p e

AIO market-b CD to support ased pri cing form ula

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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

Pumps Masterflex® pumps are used for fluid transfers which are highly reactive and toxic, mainly used for mercury transfers where controlled pouring is virtually impossible. The total system consists of the Masterflex I/ P® Precision brushless drive with analog remote along with the Masterflex I/P Easy-Load® pump head and compatible Tygon® long-life tubing. The quantity of the mercury flow can be controlled by varying the pump speed and occlusion. The mechanical components of the pump do not become contaminated. The mercury only comes into contact with the tubing. This decreases the risk of exposure to elemental mercury and its vapors. Only concern is about the safe discarding of the tubing when it becomes necessary to replace it. Finally, because the tubing is clear, the operator can visually observe the transfer. This provides an added level of confidence that the process is working well. Cole-Parmer India Mumbai - Maharashtra Tel: 022-6716 2222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Laboratory chillers Polystat Laboratory Chillers has quick ramp-up and cool-down with

all operational and preventive maintenance accessed through the front panel. Designed to provide temperature control with the flexibility needed for demanding applications, they fit comfortably on a laboratory bench top. These chillers feature a temperature range of -10 to 80°C. The chillers allows the user to choose between five temperature set points. The air-cooled refrigeration system eliminates need for external water source and the small internal reservoir limits evaporation. With built-in energy-saving mode, this series provides an environmentally friendly option for any laboratory. This mode activates a responsive control that will allow the chillers to operate with minimal energy consumption. Cole-Parmer India Mumbai - Maharashtra Tel: 022-6716 2222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Online washing/cleaning/drying system This Online system has the following sections: Washing section which is equipped with large-opening plastic modular belt conveyor with side-walls where high washing efficiency is achieved, Ultrasonic online cleaning section where

ultrasonic waves generating transducers are built into the chamber of this section, just under the side-wall conveyor belt, Hot air drying section where continuous drying of wet components is done & Inspection conveyors which is equipped with belt suitable conveyors driven with a variable frequency drive for online inspection of components.

platform and a host of hardware developments, including a new frequency-matching RF generator and 3rd generation Octopole Reaction System (ORS3), all three 7700 series mainframes provide unrivalled levels of performance and ease-of-use. Agilent Technologies India Pvt Ltd New Delhi Tel: 011-51496664 Email: agilent@agilent.com Website: www.agilent.co.in

Pharma inspection machine NTB International Pvt. Ltd. Pune-Maharashtra Ph: 02135 309 201 / 235, Fax: 02135 309 200 Email: conveyor@ntbindia.com

Metal analyser The 7700 series ICP-MS metal analyser is productive, simple-touse, high sensitivity, low background, better interference removal, increased flexibility, easier to maintain and service. This workhorse 7700x is used for most applications, and in high-throughput commercial labs. It is designed specifically for semiconductor applications. The new 7700e offers a simplified and easy-to-use system for routine analysis. Featuring a new, configurable MassHunter software

The paper folding, shrink pack and pharma inspection machines are tested for CE marking, and thus fulfill one of the major statutory requirements of European Union. A range of customised solutions as per pharma industry requirements is also offered. Pharma inspection solutions include: pharmacode readers, leaflets and cartons. These have been specially designed for online checking of pharma codes printed on tubes, cartons, leaflets, labels, etc. Pratham Technologies Pvt Ltd Pune - Maharashtra Tel: 020-24352624 Mob: 09822047399 Email: enquiry@prathamtech.com Website: www.prathamtech.com

Mod er n P har m a•1 - 15 A ugus t 2 012

Products

Liquid-ring vacuum pump The single and doublestage liquidring vacuum pump is silent in operation. Design of the mechanical shaft seal ensures adequate protection to the shaft and provides for ease of maintenance. This leads to minimal time required for servicing thereby cutting down time to the barest minimum. The pump is rugged in design, reliable in performance and easy to maintain. Acmevac Sales Pvt Ltd Mumbai - Maharashtra Tel: 022-28375837, Mob: 09223388105 Email: acmevac@vsnl.com Website: www.acmevac.com

Suspension centrifuge The fourp o i n t suspension centrifuge is mounted on an inertia plate with anti-vibration mounts, thus eliminating the cost of heavy foundation. It also eases relocation of the machine. Only a few bolts are to be grouted to prevent lateral movement of the machine during operation. Maintenance of suspension system associated with pendulum suspension machine is eliminated. The centrifuge is employed in medium-to-high output processes in bulk durgs, pharmaceuticals, food, flavours and chemical industries. It is offered in complete stainless steel construction and conforms to GMP standards. United Engineering Enterprises Mumbai - Maharashtra Tel: 022-23083990 Email: uenggent@gmail.com Website: www.united-centrifuges.com

Insulation materials T h e s e insulation materials include flexible foam produced from melamine resin. The three dimensional structure of the foam is made up of a microscopic, slender skeletal structure that delivers insulation properties. As a result of its unique design and inherent nature of the design, it offers properties such as high temperature resistance, low bacterial growth, 25/50 fire rating, ASTM C-1410, etc. IUS Equipments Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-56116626, Mob: 09960110373 Email: iusequip@vsnl.net Website: iusequip.com

Lyophiliser The lyophiliser is used for pharmaceuticals, biotechnology and allied industries. Lyophilisation is the preferred drying process, for heat labile substances or where any physical, chemical or enzymic changes are detrimental to the products and its applications. Sublimation of

frozen ice directly in the form of vapour under high vacuum is the basis of lyophilisation process. The system offers optimal flexibility in programming the recipe to suit a wide variety of products. The drying chamber is designed for full vacuum and overpressure of 2.5 bar. Machinfabrik Mumbai - Maharashtra Tel: 022-25555596 Email: machinfabrik@vsnl.com Website: machinfabrik.com

Air classifier The air classifier is a screenless machine used for grading offline powder into distinct coarse and fine grades from 60 mesh down to 40 microns. This air classifier-type separating machine is operated in closed circuit with existing equipment, such as feed from the hopper, bins pulveriser, cyclone, etc. It is manufactured in closed tolerance and well balanced to give trouble-free operation. The material is fed through the top input pipe down on a revolving distributor plate. The fluidised particles are propelled to the sides of the inner cone by whizzer blades and separated from the re-circulating air stream between inner and outer ring. Premium Vijimech Pvt Ltd Ahmedabad - Gujarat Tel: 079-40083450, Mob: 09712987467 Email: sales@vijimech.com Website: www.vijimech.com

Gas monitor The range of this gas monitor is 0-5 ppm (V/V), resolution is 0.1 ppm, and the response time is typically less than 60 seconds. Detection principle is based on the sealed electromechanical sensor. The operating life of the sensor is expected to be of 1-year. The operating temperature ranges from 0 to 50°C. It has a LCD with battery indication.The alarm is both viewable and audible. Uniphos Envirotronic Pvt Ltd Dist Valsad - Gujarat Tel: 0260-2730156 Email: cel@uniphos.com Website: www.uniphos-she.com

Aerosol generator The aerosol generator (fogger machine) is used for sterilising air in the production shops of pharma, food, biotech and healthcare industry. This fogger machine takes care of 5,000 cu ft volume in single fill giving 100 per cent efficacy. The portable fogger machine is tested for droplet size of aqueous formulations in sub-microns. It generates droplet size in sub-microns and is approved by nuclear division of BARC, nuclear power stations and is patronised by leading hospitals and pharmaceutical industries. The machine comes with a 5 ltr capacity tank made out of best grade disinfectant tank & wetted parts. Gouri Engineering Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27701285 Email: gouriengg@vsnl.com

Symmetrical gravimetric analyser

Mini bilayer press

The model SGA100 symmetrical gravimetric analyser is a continuous gas flow adsorption instrument specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version) and 250°C (high temperature version), at an ambient pressure. This gravimetric analyser is available in a size of 18”width x 30” height x 20”diameter with a weight of 125 lbs. The symmetrical gravimetric analyser finds applications in pharmaceuticals, chemicals, drugs, food products, paper, fibres, powders, carbon, catalyst, etc.

The mini bilayer press is designed to represent two-layer tablet productions at a small scale. With its larger turret diameter, variable speed allows for realistic scale up to larger rotary presses. It is provided with two force feeder system, which helps in maintaining uniform die fill and represents production equipment. It is provided with pressure compensation hydraulic system. Tablet thickness and weight adjustment settings are outside the machine. It is designed as per cGMP norms. All parts in the compression zone are of SS-304 or electroless nickel-plated.

Smart Instruments Company Thane - Maharashtra Tel: 0251-2801123,Mob: 09323509969 Email: smartins@vsnl.net Website: www.smartinsrument.com

Aayush Techno Pvt Ltd Ahmedabad - Gujarat Tel: 079-25898901 Email: contact@aayushtechno.com Website: www.aayushtechno.com

Single-source diffractometer

Blister packing machine

The Xcalibur-E is a most popular single wavelength system for routine crystal structure determination, although it is also suitable for more challenging high resolution electron density studies for small molecules. It comes mounted with fine focus molybdenum or copper Enhance X-ray source and Eos CCD detector, the fastest and most sensitive CCD detector available today. This is user-friendly software that can fully automate the crystallography experiments and produce accurate molecular structures in just three clicks. Single wavelength molybdenum or copper fine focus enhances X-ray source.

The model PBM140C high-speed mass production blister packing machine is designed to pack all types of capsules, tablets, soft gels, injection solution, syringe and other small laboratory or hospital preparation products. It packs small products in different types of clamp shell packages. It is widely used in pharmaceutical, herbal, food and other related industries. It is also suitable for packing with aluminum/ PVC, paper/plastic laminated materials. This machine consists of aluminum foil automatic feeding, upper and lower cobweb male and female joining, multistage cylinder heat sealing, automatic indenting, batch number printing and aluminium alloy double heating.

Agilent Technologies India Pvt Ltd New Delhi Tel: 011-46237100 Email: agilent@agilent.com Website: www.agilent.co.in

Advanced Liquid Packaging Arizona - USA Tel: +1-602 -4900220 Email: sales@induction-sealers.com

Powder characteristics tester

Sanitary tubes fittings

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 stateof-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, userfriendly software, reduce analysis time, complies with FDA tapped bulk density (USP) ASTM, Kawakita’s equation for Compressibility, etc.

A wide range of stainless s t e e l sanitary tube fittings for pharma, food, beverages, breweries, cosmetics and allied industries are offered. The range includes bends, Tees, reducers, pipe, support and sight glass, etc. These are available in tube OD sizes ranging from ½” to 6”. End connections available are triclamp, DIN and SMS. These fittings are manufactures from SS-304, 316 and 316L, duly electro polished. All these products confirms to cGMP and FDA standards. Elastomers offered are of food grade and can be offered in EPDM, neoprene, silicon and viton.

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

Cris Engineering Works Mumbai - Maharashtra Tel: 022-2685 9440, Mob: 09892273314 Email: roque_ferns@rediffmail.com Website: www.criseng.com

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

Modern Pharma

Mo de rn Ph a rm a â&#x20AC;˘1 -15 Au g u s t 2 012

Marketplace

Mod er n P har m a•1 - 15 A ugus t 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

Pg No

10 Stn. pilot press ......................................................... 7 Advertisement of pharma diplomas by IPER ........ 17 Aerosol generator.......................................................... 28 Agitators ......................................................................... 14 Air classifier ................................................................... 28 Alpha press ...................................................................... 7 Analytical instrumentation........................................FIC Analytical instruments ................................................... 3 Autoclave gaskets .......................................................... 29 Autoclaves ...................................................................... 13 Automatic carton over printing with embossing machine ....................................................................... 29 Automatic label gumming machine........................... 29 Batch disperser ........................................................... 14 Bearing ........................................................................... 22 Blister packing machine............................................... 28 Braided house................................................................ 29 Bulk bag filler ................................................................ 29 Cable............................................................................. 29 Cable carrier .................................................................. 22 Cable connector ............................................................ 22 Calorimeters .................................................................. 14 Capsule filling machines .............................................. 13 Car washing hose.......................................................... 21 Carton dispensing machine......................................... 29 Cartoners ....................................................................... 13 Centrifugal monoblock................................................ 29 Chain .............................................................................. 22 Chiller............................................................................. 27 Chromatography............................................................. 3 Coating machine............................................................. 7 Cold room ..................................................................... 27 Colloid Mill Std/GMP Model ....................................... 7 Columns........................................................................... 3 Columns & chemistries .............................................FIC Comminuting mill.......................................................... 7 Compact pneumatic cylinder.....................................BC Condensing unit ........................................................... 27 Control panel ................................................................ 27 Cords .............................................................................. 29 Corona treater sleeves .................................................. 29 Corrugated tube heat exchanger................................... 8

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De-dusting & de-burring ............................................ 7 Disperser ........................................................................ 14 Double rotary tableting machine ................................. 7 Double sided rotary...................................................... 15 Dry vacuum pump....................................................... 29 Drying oven..................................................................... 7 Dust extractor ................................................................. 7 Electric actuator & gripper ......................................BC Elemental analysis........................................................... 3 Empower......................................................................FIC Evaporating unit ........................................................... 27 FBD gasket .................................................................. 29 Fluid bed processor ........................................................ 7 Fluid bed system ............................................................. 7 Garden hose / power spray ....................................... 21 Gas monitor .................................................................. 28 Gaskets ........................................................................... 29 Giga press......................................................................... 7 Guided compact pneumatic cylinder........................BC Hand / power operated label gumming machine .. 29 Heat exchanger................................................................ 8 Heating bath .................................................................. 14 High pressure homogeniser ........................................ 14 High speed automatic big size label over printing machine ....................................................................... 29 High speed automatic carton over printing machine ......29 High speed automatic label counting machine ........ 29 High speed automatic lid dispensing machine......... 29 High speed automatic wallet dispensing machine ... 29 High speed tablet presses............................................. 15 Hot plate ........................................................................ 14 HPLC........................................................................3, FIC Hydraulic accessories.................................................... 21 Industrial chilling equipments ................................. 27 Inflatable gaskets ........................................................... 29 Informatics ..................................................................FIC Inline disperser.............................................................. 14 Insulation materials ...................................................... 28 Kneading machine ..................................................... 14 Laboratory chillers ..................................................... 27 Laboratory reactor ........................................................ 14 Laboratory software...................................................... 14

Product

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Liquid sterile filling machines in vials / cartridges / syringes & ampoules .................................................. 13 Liquid-ring vacuum pump ......................................... 28 Lonizer ..........................................................................BC Lyophiliser...................................................................... 28 Magnetic stirrer .......................................................... 14 Mass mixer granulator ................................................... 7 Mass spectroscopy .......................................................... 3 Medium speed tablet presses....................................... 15 Mega press ....................................................................... 7 Metal analyser ............................................................... 27 Mill ................................................................................ 14 Mini bilayer press.......................................................... 28 Mini CM mill .................................................................. 7 Mini roll compactor ....................................................... 7 Molecular spectroscopy ................................................. 3 Monoblock high vacuum pump ................................ 29 O rings ......................................................................... 29 Oil seal high vacuum pump........................................ 29 Online washing/cleaning/drying system.................... 27 Other process equipment ............................................ 15 Overhead stirrer ............................................................ 14 Packaging solutions ..................................................... 9 Pharma inspection machine ....................................... 27 Pharmaceutical packaging solutions ............................ 9 Pilot / lab scale tablet presses ...................................... 15 Pilot plant ...................................................................... 14 Plastic masterbatches.................................................... 29 Plate heat exchanger ....................................................... 8 Pneumatic tools & accessories .................................... 21 Powder characteristics tester........................................ 28 Prefilled syringe components ........................................ 9 Profiles............................................................................ 29 Pumps ............................................................................ 27 Punches & dies ................................................................ 7 Pure steam generators .................................................. 13 Rapid endotoxin detection system........................... 29 Rapid mixer Std .............................................................. 7 Refrigerated compressed air dryer.............................BC Regular hose / pesticide spray hose ............................ 21 Roll compactor................................................................ 7 Roller compaction systems .......................................... 15

Product

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Rotary evaporator ......................................................... 14 Rotary gear .................................................................... 29 Rotary lobe pump ........................................................ 29 Rotary tablet press ........................................................ 15 Rotary vacuum pump .................................................. 29 Sanitary centrifugal.................................................... 29 Sanitary tubes fittings................................................... 28 Screw pump................................................................... 29 Seals ................................................................................ 29 Sections .......................................................................... 29 Self priming monoblock.............................................. 29 Shaker ............................................................................. 14 Sheet ............................................................................... 29 Silicone rubber sleeves (ITI approved) ...................... 29 Silicone transparent platinum cured tubings............ 29 Single rotary tableting machine .................................... 7 Single stage monoblock vacuum pump .................... 29 Single-source diffractometer ....................................... 28 Solid-liquid mixer ......................................................... 14 Special TPU gas hose ................................................... 21 Sponges .......................................................................... 29 Squares ........................................................................... 29 Strips............................................................................... 29 Submersible ................................................................... 29 Suspension centrifuge .................................................. 28 Symmetrical gravimetric analyser .............................. 28 Tablet press machine.................................................. 15 TC gaskets ...................................................................... 29 Thermostat & vacuum dryer / mixer ........................ 14 Tissue culture consumables.......................................BIC Tooling & spares ........................................................... 15 Transparent tubings...................................................... 29 Triplex plunger .............................................................. 29 Two stage vacuum pump ............................................ 29 UHPLC........................................................................... 3 UPLC ............................................................................FIC Vacuum conveyor ....................................................... 29 Vertical inline ................................................................ 29 Water for injection generation stills ........................ 13 Zero liquid discharge effluent treatment ................ 11

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Advertiser’s Name & Contact Details

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Advertiser’s Name & Contact Details

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Bosch Limited T: +91-91-80-41768218 E: narendra.S@in.bosch.com W: www.boschindia.com/pa

IC ICE Make Refrigeration Pvt Ltd T: +91-79-65426394 E: info@icemakeindia.com W: www.icemakeindia.com

Cadmach Machinery Co Pvt Ltd T: +91-79-25841491 E: info@cadmach.com W: www.cadmach.com

Charles River T: 91-80 - 25588175 E: india.customercare@crl.com W: www.criver.com Dev Engineers T: +91-79-26403839 E: info@devpumps.com W: www.devpumps.com Eppendorf India Ltd T: +91-044-42111314 E: info@eppendorf.co.in W: www.eppendorf.co.in/tcc

Advertiser’s Name & Contact Details

Pg No

Reynders Label Printing India Pvt L T: +91 149 3305400 E: india@reynders.com W: www.reynders.com

Igus India Pvt Ltd T: +91-80-39127800 E: info@igus.in W: www.igus.in

Samson Extrusion Ind Pvt Ltd T: +91-022-23422238 E: samson7@vsnl.com W: www.samson-grp.com

Ika India Private Limited T: +91-80-26253900 E: process@ika.in W: www.ika.in

Shende Sales Corporation T: +91-020-24488005 E: shende@shendesales.com W: www.shendesales.com

INOS Technologies Pvt Ltd T: +91-79-25842712 E: info@inos.in W: www.inos.in

SSP Pvt Limited T: +91-91-129-4183700 E: info@sspindia.com W: www.sspindia.com

FIC

Institute of Pharmaceutical Education & Research T: +91-020 - 25234347 E: mahesh.burande@gmail.com W: www.pharmadiplomos.com

Techno Industries T: +91-2762-224814 E: info@sevitsil.com W: www.sevitsil.com

Hapman India T: +91-265-2517505 E: info@hapman.in W: www.hapman.in

Jacsons Engineers T: +91-79-25841814 E: info@jacsonsengrs.com W: www.jacsonsengrs.com

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

Heattrans Equipments Pvt.Ltd T: +91-79-25830742 E: info@technoind.com W: www.technoind.com

Joyam Engineers & Consultants Pvt Ltd T: +91-79-26569533 E: joyam@joyamvactech.com W: www.joyamvactech.com

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

Prayag Polytech Pvt Ltd T: +91-011-47262000 E: delhi@prayagmb.com W: www.prayagmb.com

West Pharmaceutical Services Singapore Pvt Ltd T: +91 40 40021790 E: sales.india@westpharma.com W: www.westpharma.com

HRS Process T: +91-020-66047894 E: info@hrsasia.co.in W: www.hrsasia.co.in

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BIC

Our consistent advertisers

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