Modern Pharma August 1-15 by Infomedia18

1-15 Augus t 2013 I Vol 2 I N o 3 I `10 0

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In Conversation With 16

Special Focus 18

Special Focus Interface 23

Energy Management 26

Dr Muhammed Majeed Founder and Managing Director, Sami Labs Ltd

CRAMS in India Opening up avenues with regulations

Dr Ravi Sobti Independent pharmaceutical consultant

Renewable energy sources How can the pharma industry benefit?

Exim Bank pitches unique long-term product for Indian pharma firms ccording to a study by Export-Import Bank of India (Exim Bank), the size of the Indian pharmaceutical industry was around $ 29 billion in 2011-12, but in value terms, it constituted only 1.2 per cent of the global pharmaceutical market. To boost the export capability of Indian pharmaceutical companies, Exim Bank has decided to expand the scope of its finance to pharmaceutical companies for extended repayment periods. Eligible export oriented companies can avail finance from Exim Bank for a maximum repayment period of 10 years with a moratorium of upto 36 months. The cost of compliance with USFDA norms is high, for example, an USFDA approved Active Pharmaceutical Ingredient (API) manufacturing facility can cost up to

` 300-million to ` 400 million and formulations manufacturing plant may cost about ` 500 million to ` 600 million. Furthermore, the average gestation period required for setting up these plants is in the range of 18-24 months. Despite possessing potential to increase share in global exports, many Indian pharmaceutical companies suffer due to their inability to meet the stringent compliance norms of European countries and the US. To increase market share, the industry needs to penetrate deeper into the regulated markets, which calls for accreditation of more and more facilities of Indian manufacturers. To meet the expectations of the Indian industry and to cope with longer average gestation period to meet the USFDA or other similar regulatory

requirements, Exim Bank has decided to provide long-term finance to pharmaceutical companies, with a maximum repayment period of 10 years. The expenses would cover interalia, all expenditure incurred/to be incurred for establishment of a USFDA approved facility. Exim Bank has been closely associated with the growth of the Indian pharmaceutical industry. The Bank has been helping pharmaceutical units in the entire value chain starting from bulk-drug manufacturing to APIs and formulations, while supporting R&D and other activities. In 2012-13, the Indian pharmaceutical industry spent around 5 per cent of the total sales on R&D activities. Though it is higher than the average R&D expenditure in manufacturing sector (estimated to be around 1 per cent), as in comparison to developed countries, such as

US or Germany, it is very low. Thus, it is imperative for the Indian pharmaceutical industry to scale up its R&D intensity and strengthen its position in the global market sphere. In order to assist the industry to emerge stronger in terms of the R&D capabilities, Exim Bank also extends term finance for both capital and revenue expenditure to eligible export oriented firms/ companies under the Bank’s Research & Development lending programme. Under this programme, finance is provided up to 80 per cent of the eligible expenditure. The normal tenure of the loan is 7 years, however, longer tenures with suitable interest resets are also allowed in specific cases. Exim Bank continues to work closely with the Ministry of Commerce and Industry to meet the various requirements of the Indian pharmaceutical industry.

Lupin to market MSD’s pneumonia prevention vaccine in India rug major, Lupin has inked an in-licensing agreement with pharma company MSD. As per the terms of the agreement, Lupin will market MSD’s pneumonia prevention vaccine under a different brand name in India. Mumbai-based Lupin will have a non-exclusive licence to market, promote and distribute MSD’s 23-valent Pneumococcal polysaccharide vaccine (PPSV) under a different brand name in the country. “We believe that the partnership is an important step forward as both companies share a common

passion and commitment to formulations business is all set to make a meaningful difference take a giant leap forward.” to the lives of patients suffering MSD India, which is an affiliate from pneumococcal of Merck & Co diseases in India,” Inc, operates said Shakti in more than Chakraborty, Group 140 countries. President, India & It would also CIS countries, Lupin continue to sell Ltd. “Our strong the vaccine in presence across the country. diverse therapies Further, places us in a unique Lupin’s India y, Shakti Chakrabort position from where business grew Group President, Lupin Ltd we can consolidate by 23 per India & CIS countries, and grow into being cent clocking a top 3 player within the Indian in revenues of ` 23,840 market. Powered with a passionate million during 2013. field force, Lupin’s domestic The 3rd largest Indian pharma

Snippets

Unichem Lab posts Q1 results at ` 360.9-million The board of directors of Unichem Laboratories Ltd approved the first-Quarter (Q1) unaudited results for financial year, 2013-14. The company recorded a total income of ` 265.57 crores for the quarter ended June 30, 2013 as against ` 264.86 crores in the corresponding quarter of the previous year, thus recording a marginal increase. Profit after tax for the current quarter stood at ` 36.09 crores as against ` 33.14 crores recorded in the corresponding quarter of the previous year. This shows an increase of 8.90 per cent.

player by sales globally, the company has been consistently outperforming the Indian pharmaceutical market with CAGR of 20.2 per cent over the last five years. Powered by a 5,200 specialty sales force, Lupin has in-licensed 37 drugs in the past four years, eight out of which were first-of-its-kind drugs for the Indian market. Lupin has successfully executed similar such arrangements with Eli Lily for Diabetes and Novartis earlier. It seems to have become a partner of choice for such deals within the Indian market. Anubhav Sharma

Ranbaxy’s Mohali and Toansa units under USFDA scanner The US drug regulator, US Food and Drug Administration (USFDA) has issued warnings on two of Ranbaxy’s facilities last year. If Ranbaxy fails to address the concerns properly, an import ban could follow. The USFDA reportedly wrote to Ranbaxy in December 2012, red-flagging certain manufacturing practices at its main Active Pharmaceutical Ingredient (API) plant in Toansa, Punjab.

Also, through ‘Form 483’ USFDA raised concerns in September 2012, on the Japanese, Daiichi Sankyoowned drug manufacturer’s Mohali unit. Form 483 is used to warn drug manufacturers of any concerns by the regulator before taking the next step of issuing an import ban. Ranbaxy was quoted saying that, “All 483s have been satisfactorily responded by the company.” But it remains unclear if the issues raised were properly addressed.

Editor’s Pick Inside & Outlook: Automation Trends

Mode r n Ph a r ma | 1-15 August 2013

IT-based automation in pharma

Will SMEs be the new demand drivers? The role of Small and Medium Enterprises (SMEs) as key demand drivers in promoting the growth of the pharma industry in India is undeniable. However, integration of advanced technologies helps SMEs address challenges faced in the daily operations. It is time that the contributions of these SMEs are projected in the right light to provide patients with safe access to quality medicines. ndia has more than 900 million users of mobile handset technolog y and it is rapidly growing every day. Such technologies have empowered the consumers to seek and share information on a real-time basis. Even with such empowerment, our policy makers are not doing enough to harness such technologies to build the capacity of the Small and Medium Enterprises (SMEs). This will help build a strong regulatory framework to address issues on health and safety of the consumers in India. Regrettably, to counter the prevalence of spurious and not-of-standard medicines that often impact the most vulnerable and poorest Indian populations; this can be easily tackled through implementation of technology, which is yet to get mandated for all the manufacturers of pharma products in India. On the other hand, it is projected that the SMEs do not wish to adopt such technologies and are against the rights of the patients to access safe and quality medicines.

Bejon Misra Founder, Partnership for Safe Medicines (PSM-I) India Initiative bejonmisra@consumerconexion.org

It is the most opportune time for SMEs to adopt user-friendly technologies to capture the domestic and global opportunities, to trigger the use of IT-based automation technologies that build credibility and trust in the Indian pharmaceutical products. The purchase of suspect drugs from community and locally-based pharmacies can have a devastating impact on Indian consumers including patient injury and death. In order to further address this important patient safety issue, consumers must be empowered to report suspected spurious medicines to public health and law enforcement officials for further investigations.

Role of SMEs Legitimate sellers should be highlighted to patients for their high quality, while illicit sellers should be identified for patient safety and consumer protection against these poor quality vendors. Beyond clear identification of legitimate and suspected medicine sellers, patients also need, easily accessible information regarding the dangers and how to detect counterfeit medicines. To be able to achieve this objective, the policy makers and the manufacturers of pharma products in India must adopt IT-based automation processes and technologies. This is the future for SMEs in India, to demonstrate their commitment towards the consumers and integrate with their existing Good Manufacturing Processes (GMP) and also Good Distribution Practices (GDP). The existing policies in India have encouraged the emergence of the SME sector as a strong player and in the coming years they would get further benefitted from various provisions in favour of the SMEs like provision of finance, training, technical marketing and other support measures, access to raw materials etc. These strategic interventions have been instrumental in ensuring the rapid growth of SMEs in the pharmaceutical industry. The SMEs play a pivotal role in supplying diversified portfolio of essential lifesaving drugs at affordable prices. It is appropriate to create the demand for use of technologies, which will enable consumers to establish trust and faith on the products manufactured by SMEs, while making them most accessible and affordable to the masses at large. Thus, the SMEs will undoubtedly be the future demand drivers in promoting and ensuring safe drug delivery.

Modern informat ion technology could be used in an extensive manner for this purpose. In addition to the scientific and technological measures, it must be emphasised that there is a need to strengthen the existing monitoring mechanisms, to upgrade and modernise the drug testing laboratories. The latter should be provided with state-of-theart technologies to sensitively and speedily test the samples sent to them for analysis. This would require equipments like mass spectrometers and others, along with training of personnel, within the country and if required, even abroad, to utilise the modern facilities to their optimum capacity. There is a need to create centralised ‘database’ of all drug and drug manufacturing units in the country, which could help trace the origin of a drug (e-pedigree) through the entire supply chain. Simultaneously, there is a need to streamline the law enforcement system, as already proposed by the Mashelkar Committee in 2003 and the Parliament of India recently.

Future projections Projected to be the 10th largest market by 2015 with 20 billion dollars, Indian SMEs engaged mainly in generic drugs are playing an important role in the global consolidation process and making strides across the world. The country has also emerged as one of the preferred global supplier of high-quality drugs and intermediates at cost-effective prices. The growth of domestic pharmaceutical industry has in fact outperformed the growth of the global pharmaceutical industry. Exports have been the major growth enabler of the Indian pharmaceutical industry in recent years. The domestic demand is also

increasing because of lifestyleassociated diseases showing a growth, least expected from a country like India. It is expected that around 80 million Indians will be above 67 years of age. This group spends around 3 to 4 times more on drugs than those in younger age groups. This has also incentivised SMEs to start functioning in rural locations of India, which can be attributed to rising rural incomes and better distribution channels. With patents coming in place, SMEs are increasingly looking towards spending more on research and development efforts. The R&D division of pharma companies are slowly moving from reverse engineering to discovering and development of new formulations. India is in fact gearing up to launch its own patented molecules in future, globally. Many Indian firms are today collaborating with multi-nationals through agreements, which will help sharing costs and ensure better results. Further, in the drug research value chain, there exists an opportunity to capture the market share in global clinical research and development market such as clinical trials, data management, testing, etc. By 2014, nearly half of all newly approved prescription drugs will be biologics. Several patents have expired on branded biologics with $ 15 billion in annual sales. In my view, it is the most opportune time for SMEs to adopt user-friendly technologies to capture the domestic and global opportunities, to trigger the use of IT-based automation technologies that build credibility and trust in the Indian manufactured pharmaceutical products, sold to the consumers in India and globally.

Zydus and IDRI collaborate for clinical development activities in India ydus and Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research and product development organisation are collaborating on the production and clinical development of IDRI’s visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease. Known as Kala-Azar in India, VL is transmitted by the bite of an infected sand fly. There are over 500,000 new VL cases and associated deaths every year. VL is the most severe form of leishmaniasis, affecting vital organs and if left untreated, the disease can be fatal. A vaccine is considered essential to control and eliminate the disease. Currently, visceral leishmaniasis (VL) occurs in four continents and is considered to be endemic in 88 countries; 72 of these are developing countries, with the disease being most common in India, Nepal, Bangladesh, Sudan and Brazil. While there are drugs to treat the disease, they are expensive and often toxic. Till date, a safe and efficacious vaccine to prevent this disease does not exist. Zydus and IDRI will collaborate to conduct clinical development activities in India with the goal of developing, registering and marketing this vaccine candidate for the prevention of VL, which will achieve the objective of global access - to ensure that the vaccine is affordable and accessible by all the people in need. Conducting trials in India is critical to determining the effectiveness of IDRI’s VL, vaccine candidate and ensuring that it is approved and available within endemic countries.

Contents

Modern Pha rm a | 1-15 August 2013

Special Focus

In Conversation With

Dr Muhammed Majeed Founder and Managing Director, Sami Labs Ltd

Outsourcing / CRAMS CRAMS in India Opening up avenues with regulations

18 20 22

Asia-Paciﬁc market for CRAMS Will India surpass China? Challenges for CRAMS in India Towards a sustainable business model

Interface Dr Ravi Sobti Independent pharmaceutical consultant

Insight & Outlook Interface Dr Andrew Wilks Executive Chairman, SYNthesis Med Chem, Australia

Automation Trends IT-based automation in pharma Will SMEs be the new demand drivers?

Energy Management Renewable energy sources How can the pharma industry beneﬁt?

Regular Sections

Editorial / Guest Editorial

32 Book Review

News, Views & Analysis

33 Products

27 Technology Transfer

37 Marketplace

28 Projects

38 List of Products & Advertisers

29 Tenders

f hts oon g i l h i Hig xt Edit ocus: h Ne cial F searc e e s Sp cal R tion ni nisa ) i l C rga s O (CRO

30 Event List Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

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Editorial

M o d e r n P h a r m a | 1-15 August 2013

Rekindling the investment sentiment he continuing global economic slump is adversely affecting India’s exports. According to the latest available data, the country’s exports have shrunk by 1.41 per cent to $ 72.4 billion in the first quarter of 2013–14. In a ripple effect, this has led to the widening of the current account deficit, which has touched an all time high of 4.8 per cent of the gross domestic product in 2012–13. Against this backdrop and with the general elections barely few months away, it is not surprising to see heightened activity in the policymaking corridors of the national capital. The moot point here is from where to begin in order to energise exports. In this context, the spotlight seems to return to the significance of Special Economic Zones (SEZs). This is primarily because SEZs have delivered more than 30 per cent of growth in exports, while the country’s trade outflow has

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

witnessed an overall decline of 1.86 per cent during the same period. Before delving into the details, it will help to trace the roots of SEZs in India. The SEZ policy came into existence in April 2000 with objectives that sought to clear the bottlenecks arising out of multiplicity of controls and clearances, to put in place world-class infrastructure and to increase India’s share of foreign direct investments. SEZs were initiated to put India on the fast lane to economic growth as well as to promote the country’s manufacturing might. However, with the passage of time, India’s current SEZ policy seems to be adding little towards sustainably boosting India’s economy, especially in the light of the recent global economic headwinds and a fast-evolving domestic manufacturing ecosystem. The time is thus ripe for a thorough review of this policy in order

to launch fresh measures that can broaden the contours of economic reform. As a welcome step in this direction, the Department of Commerce is considering a relaxation of the minimum area requirement for more sectors in the final amendments of the SEZ rules as both the industry and state governments have been facing hurdles in land acquisition. Further, the Ministry of Commerce and Industry has prioritised these proposals and asked its officials to ensure that new norms are put in place at the earliest. On being accepted, these changes will add substantial value to the policy alterations made by the government a few months ago. Moreover, it should rekindle interest among India bound investors and perhaps help the manufacturing sector regain its lost glory.

Manas R Bastia manas@network18publishing.com

Secretary General, IDMA

Guest Editorial Green manufacturing in pharma: On an impact mode t its core, green manufacturing promotes the engagement of manufacturing processes that improve the environmental impact of traditional manufacturing approaches and processes. Improvements can take many forms that encompass both input and output measures that can include using less energy and/or more sustainable energy sources, reducing waste output and recycling waste as an input, reducing the use of hazardous or toxic materials and reducing the production of hazardous or toxic materials as by products, and reducing carbon emissions and footprint. As a manufacturing ethos and against a background of increased corporate social responsibility and environmental consciousness, green manufacturing has progressed significantly in the past decade. It now forms a central component of contemporary manufacturing ‘culture’ as well as a framework for regulatory and operational goals at supra national, national, sectoral and enterprise levels. While the pursuit of environmental impact improvement remains at the core of green manufacturing, progress in approaches to this end have been extended to seek in parallel improvements in two other mainstays of manufacturing output, namely economic benefits and

Peter Bains Chairman, Fermenta Biotech Ltd

product profile benefits. The ‘win-winwin’ equation for green manufacturing is one, where environmental benefits are achieved and at the same time better cost economics of an improved product profile are simultaneously achieved and delivered. The manufacture of pharmaceutical products is a sector, which by its very nature involves the manufacture of small molecule pharmaceuticals by chemical synthesis. The sector has not been traditionally ecofriendly, demands high energy input and often requires as inputs and produces as by products, toxic or hazardous materials and as such represents a prime candidate for green manufacturing. While the early pharma industry’s response to the challenges of green manufacturing was perhaps mixed, much progress has been made in this sector in the recent past. Indeed, it is now arguable that a paradigm shift is being witnessed in which, green manufacturing approaches in pharmaceuticals are now quite aggressively being adopted and are making significant inroads towards replacing traditional chemical processes. In doing so, a material positive impact is not just created on the environment, but also on manufacturing economics and product profile. One of the most exciting, innovative and promising ways to engage green

manufacturing in pharmaceuticals is the use of biological enzymes, nature’s very own catalysts, to perform the traditional chemical reactions required more efficiently and most importantly, under mild conditions which have minimal environmental burden. In contrast to the majority of chemical reactions undertaken in pharmaceutical manufacturing, which generally require high energy inputs, temperatures and pressures often needs organic solvents for processing, and in addition, leads to the production of hazardous or toxic waste, enzyme catalysts can run these reactions with improvements in all dimensions - lower energy demands, without the use of organic solvents and under mild conditions, at ambient temperature and pressure, without hazardous by-products and therefore present a major opportunity towards progressive green manufacturing goals in pharmaceuticals. Much progress has been made in harnessing the potential of green manufacturing across multiple manufacturing sectors that include pharmaceuticals, with major emphasis on reducing environmental footprint combined with higher quality products and improved economics. ‘Green’ has now become the ‘gold’ standard for all manufacturing approaches.

News, views & analysis

Modern Pha rm a | 1-15 August 2013

Chairman of PharmaTechnologyIndex honoured amesh Kantilal Shah, Chairman, Pharmatechnologyindex. com was honoured with the ‘Rashtriya Udyog Ratna Award’ by Centre for Educational Development and Research, India. The award was conferred for ‘excellence in their respective field’ on the occasion of 14th national seminar on ‘National economic growth through individual contribution,’ held at Mumbai. The seminar was graced by eminent personalities and dignitaries. Praful

Mayakar, Director, Futurism Technologies Pvt Ltd presented the award to Shah, who possesses rich experience in media, organising and managing events at national and international events for pharmaceutical and allied industries. PharmaTechnologyindex. com is a B2B portal for pharma and allied industry of KNS Group of companies headed by Ramesh Shah, the Founder Chairman and jointly headed by Aarjav Shah, CEO. The portal provides an excellent

(28-day cycle). This drug is indicated for the prevention of pregnancy. Mylan’s partner, Famy Care Ltd, received final approval from the US Food and Drug Administration (FDA) for its

ctavis, Inc has received FDA approval for its Abbreviated New Drug Application (ANDA) for Lamotrigine orally disintegrating tablets, 25 mg, 50 mg, 100 mg and 200 mg, a generic equivalent to GlaxoSmithKline’s Lamictal® ODT. The company plans to roll out the product and Actavis intends to launch the product immediately. Being the ‘first applicant’ to submit a substantially complete ANDA, Actavis may also get exclusive marketing rights for three months. While the company failed to obtain tentative approval of its ANDA within 40 months after the date on which it was filed, the FDA

A Ramesh Kantilal Shah, Chairman, Pharmatechnologyindex.com honoured by Praful Mayakar, Director, Futurism Technologies Pvt Ltd

technological platform and market place to all pharmaceutical and allied

industrial suppliers as well as buyers. It is promoted both nationally and globally.

Mylan introduces generic version of Nor-QD ® tablets, 0.35 mg US-based, Mylan Pharmaceuticals Inc has introduced Norethindrone tablets USP, 0.35 mg. Norethindrone tablets USP, 0.35 mg, are the generics version of Actavis Nor-QD® tablets, 0.35 mg

Actavis receives FDA approval for generic version of Lamictal® ODT

Abbreviated New Drug Application (ANDA) for this product. According to IMS Health data, Norethindrone tablets USP, 0.35 mg, had US sales of approximately

$ 39-million for the 12 months ending March 31, 2013. At present, Mylan has 174 ANDAs pending FDA approval representing $ 83.2-billion in annual sales, according to IMS Health. is not making a formal determination on Actavis’ eligibility for 180-day exclusivity at this time. It will do so, only if another paragraph IV applicant becomes eligible for full approval within 180 days, after Actavis begins commercial marketing of the product. Lamictal® ODT is an antiepileptic drug indicated for the treatment of epilepsy and bipolar disorder. For the 12 months ending May 31, 2013, Lamictal® ODT has had total US sales of approximately $ 51-million, according to IMS Health data.

ConfometRx granted US patent for GPCR comprising an IC2 insertion onfometRx received US Patent and Trademark Office (USPTO) for ‘GPCR comprising an IC2 insertion,’ which covers G protein coupled receptors (GPCRs) that have a stabilising fusion in the second intracellular loop (IC2). Importantly, this patent broadly covers any GPCR that has a stable, folded protein insertion in its IC2 region, as well as crystals containing the same. Also claimed is a method of crystallising a GPCR fusion protein that has a stable, folded protein insertion in the IC2 region. This patent generically covers stabilising IC2 fusions of family A, B, and C GPCRs, which are currently of significant interest to the scientific community. This patent is one of seven US patents that are either owned by or exclusively licensed to ConfometRx that covers stabilised GPCRs. This patent is owned by ConfometRx and was awarded to Dr Brian Kobilka, Stanford Professor and ConfometRx co-founder,, who recently won the 2012 Nobel Prize for chemistry for his work in the area. ConfometRx, a leader in GPCR structural characterisation and analysis, owns or has exclusive rights to patented stabilisation technology used to solve at least 20 novel GPCR structures. Other ConfometRx patents on GPCR stabilisation are pending both in the US and abroad.

News, views & analysis

M od ern Pha rm a | 1-15 August 2013

DPCO 2013 introduced, impacts the pharma sector in India ately, the pharma industry is going through a mixed bag of feelings. While the monsoons have seen drug sales picking up, the weakening rupee has helped many exportoriented pharma companies gain. However, the industry is still reeling from the sudden changes in policies, with the Drug Pricing Control Order (DPCO), 2013 announcement. The DPCO 2013 was introduced with intent to lower drug prices such that the end user may benefit. However, the National Pharmaceuticals Pricing Policy

(NPPP) controls only the dosage forms and formulations of the 348 drugs in the National List of Essential Medicines (NLEM 2011). This could be an unhealthy trend as 80 per cent of the drugs do not fall under the purview of the NPPP. The prices of these medicines could inflate even further. Analysts are of an opinion that companies falling under this drug pricing regime would begin manufacturing other equivalent drugs of higher or lower dosages that do not fall under this classification. The DPCO has also not raised a flag about the exorbitantly

priced drugs rolled out by the multinational companies. The IMS Market Prognosis report states that 40 per cent stockists still have incomplete knowledge about DPCO, 2013 and its implication. Clarity is still an issue particularly in North India, followed to some extent in East India as well. Kumar Hinduja, Senior Director, Strategy Planning and Business Development, Pharma & Payer Solutions, IMS Health stated, “Products impacted by this new regulation experienced a dip in primary purchases and stockings, which was also

seen in the previous month. Going forward, we expect the market to recover over the next few months, as issues around market regulations (DPCO 2013, Pioglitazone ban) clear and register positive growth of 11-13 per cent in 2013.” Many industry experts are of the opinion that health insurance penetration, curbing sales of spurious drugs, focusing on a national R&D policy, noncompliance of cGMP are nagging issues that need more serious review by the Government at the moment. Pallavi Mukhopadhyay

8th Edition of European Pharmacopoeia to be available soon he upcoming 8 th edition of the European Pharmacopoeia will be available soon. It contains more than 2,220 monographs and 340 general chapters illustrated with diagrams or chromatograms and 2,500 descriptions of reagents. It is comprised of two initial volumes, to be published in July 2013, with an implementation date of 1st January 2014. As for other recent editions, noncumulative supplements will be issued three times a year, following the decisions taken at each session of the European Pharmacopoeia commission. Hence, the 8th edition will

culminate in a collection of eight non-cumulative supplements (8.1 to 8.8). This edition will be available in print and electronic versions (online and on USB key). The edition will be available in French and English, the official languages of the Council of Europe. The European Pharmacopoeia was established nearly fifty years ago, when eight member states of the Council of Europe decided to join forces to elaborate a common pharmacopoeia that would define harmonised quality specifications and requirements for medicines and their ingredients in Europe. Today, 37 European countries

are collaborating to establish comprehensive and state-of-theart pharmacopoeial standards. Revisions take account of scientific and technical evolutions, legal and regulatory developments, the increasing demand for generic and biosimilar products, new risks to public health and the globalisation of trade and commerce. The current developments in the European Pharmacopoeia include evaluation of the P4Bio pilot phase (the P4 procedure is dedicated to substances still under patent and developed in close collaboration with the respective manufacturer), the establishment of monographs on dosage forms

of biopharmaceutical substances, the continuous revision of monographs to implement the 3Rs concept (replacement, refinement and reduction) in line with EU Directive 2010/63/ EU of 22 September 2010 on the protection of animals used for scientific purposes, the review and revision of existing texts in view of needs arising from Process Analytical Technology (PAT), Real-time release testing (RTRT) or Quality by Design (QbD) concepts and the drafting and revision of general chapters in the field of chemometrics with elaboration of general text on raw materials for production of cellular and gene transfer products.

In Brief

Glenmark’s ANDAs for epilepsy drug in US faces legal challenge Glenmark Pharmaceuticals said that the applications for generics of epilepsy treatment drug, Vimpat® in US has been challenged by UCB Inc, and other companies in the US court. “UCB Inc, UCS Pharma GmbH, Research Corporation Technologies Inc and Harris FRC Corporation filed suit against Glenmark Generics Ltd and Glenmark Generics Inc in the US District Court of Delaware, seeking to prevent Glenmark from commercialising its ANDAs prior to the expiration of the US Patent No RE 38,551,” according to a statement by Glenmark. The company’s subsidiary Glenmark Generics had filed the Abbreviated New Drug Applications (ANDAs) for Lacosamide tablets and oral solution with US Food and Drug Administration (USFDA) with a paragraph IV certification, Glenmark said. “If Glenmark is successful in its challenge of the patent, it will garner 180 days exclusivity for its products,” it added. According to IMS Health data for the 12 months ending March 31, 2013, Vimpat ® tablets and solution garnered total US sales of approximately $ 353-million. Vimpat® is indicated for an adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.

News, views & analysis

Modern Pha rm a | 1-15 August 2013

Pﬁzer introduces XELJANZ® to cure rheumatoid Mylan introduces®generic version of Nor-QD arthritis with global regulatory approvals tablets, 0.35 mg fizer Inc, has received global approval for XELJANZ® (tofacitinib) to cure rheumatoid arthritis (RA) in patients, who had an inadequate response to existing therapies in several additional countries around the world, including Switzerland, which is the first European country to receive approval. Swissmedic, the Swiss agency for therapeutic products, approved tofacitinib 5 and 10 mg twicedaily (BID) as a monotherapy or in combination with disease modifying nonbiologic antirheumatic agent, Disease-Modifying

Antirheumatic Drugs (DMARD), that include methotrexate (MTX), in adult patients with moderateto-severe active RA, with inadequate response or intolerance to MTX. Tofacitinib 5 mg BID has been approved in Argentina, Kuwait and the United Arab Emirates, while tofacitinib 5 mg and 10 mg BID has also received approval in Russia. The brand name for tofacitinib in the approved markets will be XELJANZ®, except for Russia, where the brand name will be Jaquinus®. In November 2012, XELJANZ® was launched in the US, and is expected to be commercially available in Japan soon, following approval

by the Japanese Ministry of Health, Labour and Welfare (MHLW) in March 2013. Speaking on the development, Geno Germano, President and General Manager, Specialty Care and Oncology, Pfizer said, “More than 23 million people worldwide are living with rheumatoid arthritis and there remains an unmet need for additional treatments, with up to one-third of RA patients not adequately responding and about half who stop responding to any particular DMARD within five years. XELJANZ® has a novel mechanism of action for the treatment of moderate-to-severe RA. With these approvals, we

believe XELJANZ® has the potential to change the way rheumatologists treat this chronic and potentially disabling disease. We are proud to offer patients and physicians an additional treatment option.” Regulatory applications for XELJANZ® for the treatment of moderate-tosevere active RA remain under review in more than 30 additional countries. In Europe, Pfizer is seeking a re-examination of the Committee for Medicinal Products for Human Use (CHMP) negative opinion that was announced in April, and the company is currently working with CHMP on the next steps in the process.

or protection of solid pharmaceutical products against humidity, light and oxygen laminates with aluminium are used. In case of blister, a laminate with BOPA/Al/ sealing layer is used. Sealing layer mainly is PVC film. Besides PVC polyethylene and polypropylene are used. Ansapack is producing this laminate in India, using imported raw materials. In India PVC film 60-micron is available but the price is same as imported from Europe, with comparatively poor quality. Reduction in weight of the laminate is increasing the yield and reduces cost of the laminate. Reduction of thickness of sealing layer in addition, results in higher barrier related to cross migration of oxygen, water vapour and other gasses. Formability of laminate is the same as with 60 or 100 micron PVC film; it is not reduced by reduction of thickness of sealing layer. Because of same material for sealing layer (100, 60 and 30 micron PVC) no influence for seal integrity (170 °C, 0.5 sec, angle of opening 180° è > 7 N/15 mm). Besides barrier and for sealing to lid foil, sealing layer is responsible, together with aluminium, for stiffness / dent resistance of the formed material. Besides the 19 per cent more material related to same weight, further savings are possible because of higher yield. For Panblok 30 PVC, as for all other of Ansapack packaging materials, all used raw materials confirm to the USFDA (filed in its DMF) and regulation of European Pharmacopeia. The Panblok 30 PVC offers significant reduced cross migration, 50 per cent of water vapour and gasses through sealed seam, increased efficiency of blister machine, saving space in stock of packaging material and reduced cost of transportation.

US district court dismisses Teva’s lawsuit against Mylan’s ANDA for generic Copaxone®

A US district court has dismissed Teva’s lawsuit against Mylan’s ANDA for its generic version of Copaxone® (glatiramer acetate) citing infringement to Teva’s four patents (US Patent Nos. 66,514,938, 7,074,580, 7,163,802, and 7,615,359). Mylan is appealing to the federal circuit, a separate decision involving other Teva patents (USPatent Nos. 5,800,808, 5,981,589, 6,048,898, 6,054,430, 6,342,476, 6,362,161, 6, 620,847, 6,939,539 and 7,199,098), which were upheld by retired Judge Barbara Jones of the Southern District of New York. Oral argument on Mylan’s appeal was held on May 7, 2013. Mylan anticipates that a favourable appellate decision on these patents would clear Mylan for launch upon receipt of final regulatory approval.

News, views & analysis Roche secures EC approval for Erivedge oche secured European Commission’s (EC) conditional approval for Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic Basal Cell Carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. Erivedge is a new medicine that helps people with disfiguring and potentially lifethreatening form of skin cancer. This approval makes Erivedge, a capsule taken once-a-day, the first licensed medicine for patients in the European Union (EU) with this disfiguring and potentially lifethreatening form of skin cancer. A conditional marketing authorisation is granted for medicinal products with positive benefit/risk assessment that satisfy an unmet medical need and whose availability would result in a significant public health benefit. Under the provisions of the conditional approval, Roche will provide additional data on Erivedge in advanced BCC from an ongoing global safety study. Commenting on the approval, Hal Barron MD, Chief Medical Officer and Head of Global Product Development, Roche said, “This approval is a great news for patients with advanced basal cell carcinoma, who previously had no medicines to treat the disease. Erivedge substantially reduced tumour size in patients during clinical trials, and we are pleased that Erivedge will now be available to patients in the European Union.”

Strides announces WHO pre-qualification for Artemether+Lumifantrine Strides Arcolab Ltd announced the World Health Organization (WHO) pre-qualification of its anti-malarial product Artemether + Lumifantrine (AL) tablets. AL constitutes over 80 per cent of Artemesinin Combination Therapy (ACT) procured under global fund and other similar programs. The benefits of ACTs are their high efficacy, fast action and reduced likelihood of resistance developing. WHO currently advises that all malaria cases should be treated with ACT. It is estimated that only about 10 per cent of the actual incidence gets reported. ACT procurement plan for 2013 is estimated to be in the region of $ 450 million. Speaking on the development, Manish Gupta, Chief Executive Officer, Pharma, Strides Arcolab said, “This approval is another initiative by Strides to make high quality, affordable medicines available in the African subcontinent and other middle-income countries. It complements our basket of products in the anti-HIV/AIDS and anti-TB therapies for these markets. With this approval, Strides becomes the only player to provide complete treatment portfolio in the major diseases of HIV, TB and malaria, which continue to plaque the low and middle-income countries.” The product will be manufactured with USFDA approval and WHO pre-qualified facility in Bengaluru. The supplies of the product will commence immediately.

M od ern Pha rm a | 1-15 August 2013

Advanced batch statistics software for optimised productivity in pharma harmaceutical manufacturers will benefit from enhanced productivity on their processing lines with the newly upgraded pharma statistics software from METTLER-TOLEDO Garvens. Developed in collaboration with pharmaceutical manufacturers, the pharma statistics software collects product inspection information and stores it order-wise, according to the order number and product batch, thus facilitating data analysis. This simplifies monitoring of check-weighing data for manufacturers and helps them demonstrate to customers that each product batch is of the correct size

and weight, as well as to track batches throughout the production line. Additionally, manufacturers can now easily examine operational changes to thecheck-weighers, thereby enabling them to study the influence of systems’ parameter settings on production and reject rates, thus optimising productivity.

Newly upgraded pharma statistics software from METTLER-TOLEDO Garvens

The programme also records log-in attempts to enhance security by preventing unauthorised adjustments to checkweigher settings. With its intuitive graphic display, pharma statistics, streamlines machine set up for straightforward product changeovers. Passwordrestricted access and record of login attempts ensure only authorised personnel to access stored data or alter settings, thereby enhancing data security. Reports can be easily exported to a Universal Serial Bus (USB) or printed, and hence facilitates data storage. The software can also export records to Microsoft Excel for further analysis. “In an increasingly competitive economic climate, pharmaceutical manufacturers need to boost

production-line efficiency,” explained Kerstin Bernhart, Marketing Manager, METTLER-TOLEDO Garvens. “Technology capable of streamlining product inspection data monitoring process can help manufacturers meet this challenge head on and enhance compliance with industry regulations.” Easily installed on existing checkweighing equipment with minimum downtime, the upgraded pharma statistics software will be incorporated into new technology from METTLERTOLEDO Garvens. All existing XS checkweighers including the XS2 and XS2 MV combination checkweighing and vision inspection systems can be upgraded with the software.

News, views & analysis

Modern Pha rm a | 1-15 August 2013

Amgen evaluates study results of XGEVA® for treatment of GCTB

Ipsen to sponsor neurologic diseases research programme at Harvard Medical School

mgen announced that Lancet Oncology published planned interim results from an international, open-label, Phase 2 clinical trial that is evaluating XGEVA® (denosumab) in adults and skeletally mature adolescents diagnosed with Giant Cell Tumour of Bone (GCTB). The study’s primary endpoint is the safety profile of XGEVA®. Secondary endpoints are the time to disease progression and the proportion of patients without any surgery at six months. Based on the investigators’ interim assessment, 96 per cent of patients with surgically unsalvageable GCTB had no disease progression after a median follow-up of 13 months. In those with salvageable GCTB, whose surgery was associated with severe morbidity, 74 per cent of patients

psen will sponsor an R&D programme at the Harvard Medical School on novel engineered botulinum toxins. Following the agreement, Ipsen will fund research for at least three years with an aim to discover, evaluate and develop novel engineered recombinant botulinum toxins for the treatment of serious neurologic diseases. This collaboration will see combination of Harvard’s discovery platform and botulinum toxins engineering expertise with Ipsen’s know-how on drug discovery and pharmaceutical R&D. Ipsen will have exclusive worldwide rights on any candidate recombinant toxin stemming from the collaboration. Ipsen will further be responsible for the development and marketing of the new toxins. It will make associated upfront, milestones and royalty payments to Harvard. Dr Min Dong, Instructor in Microbiology and Immunobiology, New England Primate Research Center and Department of Microbiology and Immunobiology of Harvard Medical School said, “Our collaboration with Ipsen to discover novel engineered botulinum toxins will greatly facilitate our research efforts to potentially bring novel therapeutics to the benefit of patients suffering from highly debilitating conditions.” Claude Bertrand, Executive Vice president R&D, Chief Scientific Officer at Ipsen added, “This collaboration further strengthens Ipsen’s position in biotechnology as a major player focused on the discovery and development of therapeutic toxins to provide innovative therapies for patients with serious neurologic disorders.”

required no surgery, and 62 per cent of patients, who had surgery, underwent a less morbid procedure than planned. Overall, 72 per cent of patients had objective tumour response, per protocol defined criteria, including 25 per cent of patients who had an objective tumour response, according to modified Response Evaluation Criteria in Solid Tumours (RECIST). Drug’s overall safety profile was found to be consistent with the known safety profile of XGEVA® in patients with advanced cancer. Osteonecrosis of the jaw was reported in one per cent of patients. Hypocalcaemia adverse events, all non-serious, were reported in 5 per cent of patients. The most common severe adverse events were low phosphate levels, back pain, pain in extremity, depression, musculoskeletal pain and anaemia. Serious adverse events were reported

in 9 per cent of patients. No treatmentrelated deaths were reported. Sean E Harper, Managing Director, Executive Vice-President R&D, Amgen said, “These results demonstrate the effectiveness of XGEVA® in the treatment of giant cell tumour of the bone and reinforce our understanding of this rare disease in which RANK Ligand (RANKL) plays a central role. XGEVA® represents a much-needed treatment option for patients suffering from giant cell tumour of the bone that cannot be adequately treated with surgery.” GCTB is a rare, osteolytic tumour of the bone that often results in complete destruction of the affected bone, leading to bone fracture, joint dysfunction, deformity or amputation. GCTB typically affects individuals between the ages of 20 to 40.

CCI studies drug sector practices amid concerns over availability of cheaper drugs air trade regulator, Competition Commission of India (CCI) has initiated a comprehensive study on the domestic pharmaceutical industry, including prevalent pricing and selling practices, amid concerns over availability of cheaper drugs. CCI, which keeps on anti-competitive practices at the market place, has started a study on the domestic pharmaceutical industry. A senior Commission official said the study is looking into various dimensions of manufacturing and sale of pharmaceuticals. “Various issues such as patent regime, the process of manufacturing, pricing, reasonable terms and conditions and the sale of drugs through chemists and druggists, will be looked into,” the official said. The study comes at a time when the government is making efforts to make drugs more affordable for the common people. In this regard, the new drug policy that could help make medicines cheaper is being implemented. The National Pharmaceutical Pricing Authority (NPPA) has started fixing the ceiling prices for more than 300 drugs.

News, views & analysis

M od ern Pha rm a | 1-15 August 2013

Ukraine grants GMP approval to Venus for all its manufacturing facilities enus Remedies Ltd, a leading research-based pharmaceutical company receives good manufacturing practices (GMP) approval from Ukraine for all its nine manufacturing facilities. Ukraine is a member nation of the Pharmaceutical Inspection Convention/ Cooperation Scheme (PIC/S). Venus is the only Indian company to get Ukrainian GMP approval for large volume parenterals for its Panchkula plant in Haryana. The certification was granted by the National Agency for Food and Drug Administration and Control (NAFDAC), Ukraine after three rounds of audit. The nine facilities cater to the manufacture of cephalosporin injection, carbapenem, oncology liquid injection, oncology lyophilised injection, ampoules, liquid vials, general lyophilised vials, prefilled syringes and intravenous (IV) fluids.

Shasun Pharma successfully completes USFDA inspection

hasun Pharmaceuticals Ltd, a global pharmaceutical organisation offering world-class capabilities and facilities has successfully completed USFDA inspection. The main focus of this inspection was on post-approval of certain products that have been commercially launched recently by customers in US. On completion of this inspection, the USFDA authorities concluded that the facilities, systems and practices comply with the USFDA requirements and that there were no recommendations or observations. The facility also underwent a Brazilian ANVISA (National Health Surveillance Agency) inspection in the first week of July 2013. This is a pre-approval inspection of New Drug Application (NDA) product with pharma major associated with Shasun. The regulatory authorities concluded that the facility, systems and practices comply with ANVISA cGMP requirements. Commenting on the inspections, S Abhaya Kumar, Managing Director, Shasun Pharmaceuticals Ltd added, “It gives me immense pleasure to state that successful completion of USFDA and Brazilian ANVISA inspection is further evidence of Shasun’s commitment to produce quality products and its strict adherence to the highest regulatory standards.”

Hailing the achievement, Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd and Director, Research, Venus Medicine Research Centre (VMRC), said, “This certification is an extended recognition for our manufacturing facilities, which are at par with international standards in terms of the quality system set by PIC/S member nations. This is the third time that we have received PIC/S recognition for quality manufacturing standards. Now, all the nine facilities of Venus, eight in Baddi and one in Panchkula, are certified with GMP by the NAFDAC, Ukraine. This has led to opening up of more opportunities for Venus to expand its product portfolio in the remaining PIC/S member countries.” With a population of 46.6 million, Ukraine is amongst the largest countries in Europe, thus making it a potentially lucrative pharmaceutical market. The

pharmaceutical market in Ukraine is expanding at a rapid pace. The $ 3-billion market is expected to grow at a Compound Annual Growth Rate (CAGR) of 16 per cent. India is the second largest exporter of pharmaceutical products to Ukraine, after Germany. According to a research report, 55 per cent of the medicines sold in Ukraine are prescription drugs, while the rest are over-the-counter (OTC) products. Only about a quarter of the drugs consumed in Ukraine are produced domestically, while the rest are imported. “Venus is in the Ukrainian market for the past 11 years. It has been regularly exporting its various oncology products, cephalosporin, carbapenem and other research products and speciality injectables to Ukraine. Today, we have 69 product registrations in Ukraine. In 2012, the total volume of our exports to Ukraine was around $ 5-million.

We aim to double this figure in the current fiscal by strengthening our export line in Ukraine,” said Dheeraj Aggarwal, Chief Financial Officer (CFO), Venus Remedies Ltd. Venus has received 65 market authorisation approvals from the Ukraine authority for its Baddi unit, while 35 applications are in the process. Besides, the Panchkula unit of the company has also been granted four market authorisations and seven are still awaited. Venus Remedies Ltd has already been granted 23 international certifications. These include recognitions by the European Union GMP, Gulf Cooperation Council (GCC), Saudi Food and Drug Authority (SFDA), the Therapeutic Goods Administration (TGA) and the Tanzania Food and Drugs Authority (TFDA).

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M od ern Pha rm a | 1-15 August 2013

Lupin gets USFDA nod for diabetes drug

UK regulator recalls 16 Wockhardt drugs

rug major, Lupin has received US health regulator’s approval to sell the generic version of Glumetza HCl ER tablets, a diabetes drug, in the American market. The company’s US-based subsidiary Lupin Pharmaceuticals Inc, has received final approval from US Food and Drug Administration (USFDA) for its Metformin Hydrochloride extended release tablets in strengths of 500 mg and 1000 mg. “Lupin believes that, it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Glumetza HCl ER tablets of 500 mg and 1000 mg, hence it will be entitled to 180 days of marketing exclusivity,” according to a statement by the company. Metformin HCl ER tablets are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type-2 diabetes mellitus. As per IMS Health data, Glumetza HCl ER tablets of 500 mg and 1000 mg had sales of nearly $ 144-million in the US in 2012-13.

K drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA) has issued a precautionary recall for sixteen medicines made by Wockhardt at its Waluj unit, due to manufacturing shortcomings. “This follows manufacturing deficiencies identified by the MHRA at Wockhardt’s Waluj site in India,” MHRA said in a statement. The sixteen ‘prescription only medicines’ include those used for the treatment of infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinsons disease, dementia in Alzheimer patients and thyroid conditions, it added. The Waluj facility makes injectables and solid dosages. Gerald Heddell, Director of Inspection Enforcement and Standards, MHRA said, “This is a precautionary recall. People can be reassured that there is no evidence

China arrests AstraZeneca official hina recently arrested an official of the British-Swedish multinational pharmaceutical major AstraZeneca. This move comes amid ongoing money laundering investigations in the British pharma company, GlaxoSmithKline (GSK). Chinese officers from the public security bureau arrived at Astrazeneca’s sales office in Citic Square, Shanghai, and were said to have detained an employee, according to reports. AstraZeneca was quoted as saying, that the investigations were related to an individual case and the company is not concerned, as it did not receive an update from the Public Security Bureau. According to reports, another US pharmaceutical company - Baxter International was also under investigation for possible malpractice at its joint venture in China. Officials from the China’s anti-trust regulator, State Administration for Industry and Commerce (SAIC) visited Belgian drugmaker, UCB earlier. SAIC is in charge of market supervision, which also looks into low-level bribery cases.

Dr Reddy’s announces the launch of Decitabine for injection r Reddy’s Laboratories has launched Decitabine for injection, a therapeutic equivalent generic version of Dacogen® in the US market. This launch follows the approval by the United States Food & Drug Administration (USFDA) of Dr Reddy’s ANDA for Decitabine for injection. The Dacogen® brand has US sales of approximately $ 260 million MAT (moving annual total) for the most recent twelve months ending July 2013 according to IMS Health. Dr Reddy’s Decitabine for injection, 50 mg is available as a single dose vial. Dacogen® is a registered trademark used by Eisai Inc under licence from Astex Pharmaceuticals, Inc.

regard the medicines made by Wockhardt are defective. So it is important that people continue to take medicines as prescribed.” This is not a patient level recall because although the medicines that are affected have not been manufactured to Good Manufacturing Practice (GMP) standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK, MHRA said. “The deficiencies identified by the MHRA during a routine inspection in March included low risk of crosscontamination because of poor cleaning practices and defects in building the fabric and the ventilation systems at the site,” it added. There was also evidence of forged documents relating to staff training records that had been rewritten, MHRA said. It is working with Wockhardt and other international regulators to resolve these issues.

Habil Khorakiwala, Chairman, Wockhardt said, “We have been issued an alert by MHRA. We would be shifting the manufacturing of products from Waluj to another facility, thereby minimising the impact of the alert.” Earlier, an import alert was also issued by the US health regulator on the same manufacturing facility.

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Modern Pha rm a | 1-15 August 2013

GW Pharmaceuticals to extend marketing authorisation for Sativex® W Pharmaceuticals plc, has filed an application under the European Mutual Recognition Procedure (MRP) seeking approval to extend the marketing authorisation for Sativex® in France to cure spasticity caused by multiple sclerosis (MS). This new regulatory application follows a decree signed by the French Minister of Health in June 2013, which amended national legislation in France such as to permit a prescription cannabis-based medicine, subject to approval by Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French regulatory authority. As with previous, Sativex® MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the reference member state.

Sativex® is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy with planned launches in another 8 European countries, along with Australia and New Zealand. Commenting on the development, Justin Gover, Chief Executive Officer (CEO), GW Pharmaceuticals said, “Sativex® meets a significant unmet

medical need for patients with MS and we look forward to working with the French authorities such as to allow this important medicine to be made available in France. The submission of this MRP for Sativex® in France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex® availability throughout Europe. We see this growth as important validation of patient and physician acceptance of Sativex® in meeting the needs of people with MS.” Almirall, an international pharmaceutical company with headquarters in Spain, is the exclusive distribution partner for Sativex® in the European Union (excluding the UK) and EU accession countries, as well as Switzerland, Norway, Turkey and Mexico.

Ranbaxy’s new anti-malaria drug SynriamTM wins innovation award anbaxy Laboratories Ltd has received the innovation excellence platinum award at the ‘ASSOCHAM Innovation Awards 2013’ in the science and technology category for its new anti-malaria drug, SynriamTM. This prestigious award was given by Jaipal Reddy, honourable Minister for science and technology and earth sciences. . SynriamTM is the new ray of hope for millions likely to get affected by malaria. The drug is efficacious and has the advantage of ‘compliance and convenience’. The course is one tablet, a day for three days and costs ` 130. Unlike artemisinin-based drugs, it has a synthetic source, the production of which can be scaled-up whenever required and a consistent supply of the drug can be maintained at low cost. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with other anti-malarial therapies. India’s first new drug, SynriamTM, was launched by Ranbaxy last year on April 25, 2012 (World Malaria Day).This drug is used for the treatment of plasmodium falciparum malaria, in adults. Ranbaxy is working to make this new treatment available in African, Asian and South American markets, where Malaria is rampant. The company also plans to submit ANDAs for market authorisation of Synriam™ in various African countries in 2013. The company also plans to extend the benefits of SynriamTM to children, in the malaria endemic zones of Asia and Africa. Malaria is a major public health concern in more than 90 countries that host about 40 per cent of the global population. This deadly disease is estimated to cause up to 250 million new infections worldwide every year. As per IMS data, over 2 million SynriamTM pills have been sold since its launch and over 700,000 patients have been treated in India. Last year, SynriamTM won the golden peacock innovative product/ service award.

Sun Pharma recalls brain haemorrhage treatment drug in US un Pharma has recalled certain lots of Nimodine capsules, a drug indicated to treat brain haemorrhage, in the US market due to crystal formation. As per the US Food and Drug Administration (USFDA) website, the company is recalling the Nimodine capsules, 30 mg, due to ‘crystallisation.’ The recall falls under Class II category, and it is done in a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. As per the USFDA, 46,387 cartons of the drug have been distributed in the US market. The recall has been initiated voluntarily by the drug maker and intimated to the drug regulator thereafter. Comments from the company could not be obtained immediately. Nimodipine capsules, 30 mg, are used to decrease problems due to subarachnoid haemorrhage (bleeding in the brain).

News, views & analysis Serum Institute of India acquires rights for tuberculosis vaccine erum Institute of India is planning to take a promising vaccine, originally developed in Germany and to introduce it into the clinical setting. By signing a contract with the Hannoverbased Vakzine Projekt Management GmbH, Serum, one of the world’s leading vaccine manufacturers has effectively secured the licence to the various patents and technologies related to the new vaccine. Scientists from the Max Planck Society, Vakzine Projekt Management GmbH, and the Helmholtz Centre for Infection Research co-developed the candidate vaccine called VPM1002 as part of a joint research project. The substance is currently undergoing phase II clinical testing. “This represents an important step in the fight against the deadly threat posed by tuberculosis – an infection that affects over two billion people worldwide,” said Bernd Eisele, CEO, Vakzine Projekt Management, a Helmholtz Centre spin-off based in Hannover, Germany. “The new vaccine is showing a lot of promise, the concept itself is highly innovative,” added Umesh Shaligram, Director of Research and Development, Serum Institute of India. The company is headquartered in Pune, India. “We are looking forward to working with Vakzine Projekt Management and hope that over the next years, we will see the vaccine successfully secure market authorisation for global distribution.” The special thing about VPM1002 is that it is being continually refined using gene technology, causing it to prevent diseases much more effectively and safely than its predecessor. Preclinical studies, two phase I clinical trials, and one phase II clinical trial have already met expectations.

M od ern Pha rm a | 1-15 August 2013

India faces shortage of yellow fever vaccine ellow fever disease is endemic in 44 countries around the world. While, 23 countries are in the African continent and 11 countries in the South American continent, India is free from yellow fever disease. Passengers visiting endemic countries can get protection with immunisation by yellow fever vaccine. Single dose of 0.5 ml vaccine provides lifelong immunity and repeated visits do not require fresh yellow fever vaccinations. Total annual demand of yellow fever vaccine for India is around 1.8 lakh doses. There are 27 yellow fever vaccination centres in the country designated by Directorate General of Health Services, Ministry of Health & Family Welfare (MoHFW). Yellow fever vaccine to these centres is supplied by Central Research Institute (CRI), Kasauli (partly 1/3rd by manufacturing and the remaining 2/3rd through imports). No private hospital/ clinics/ institutions have so far been authorised by the Government of

India (GoI) for providing yellow fever vaccinations and issue, World Health Organisation (WHO) approved certificates.

There has been shortage of yellow fever vaccine in the GoI designated yellow fever vaccination centres since March 2013. It has been due to breakdown of equipment at CRI, Kasauli, and interruption in supply of imports through WHO, due to global shortage. Due to shortage in supply, yellow fever vaccination centres were informed that they should ask all the travellers seeking vaccinations, to procure the single dose yellow fever vaccine vial (manufactured by Sanofi Pasteur) and get the WHO yellow fever vaccination certificate

(no cost was charged for this) at the designated yellow fever vaccination centres. As an interim measure, the GoI provides yellow fever vaccination at ` 300 per dose and single dose Sanofi Pasteur in market is available at ` 1100. Simultaneously, order was placed with the WHO again, for total requirement of 2.57 lakh doses (including balance requirement for 2012-13 and 2013-14). This supply order is yet to be received. As per WHO, supplies are expected in the second week of August. In view of the interruption of regular supply from CRI, Kasauli and anticipating the crisis situation, Sanofi Pasteur (the only company, which has DCGI approval, but for single dose vaccine vial) was approached for supply of 60,000 doses (10 dose vial) in April, 2013. It was mentioned that, Sanofi Pasteur does not have license for multi-dose vial, it will have to get Drug Controller General of India (DCGI) approval for GoI supply order.

NeoStem inks research agreement to develop Tregs eoStem, a leading player in the cellular therapy market, inked agreements with the University of California, San Francisco (UCSF) and the laboratories of Jeffrey Bluestone and Qizhi Tang, to develop human Regulatory T cells (‘Tregs’) for the treatment of type-1 diabetes (T1D), steroid resistant asthma and organ transplant rejection. This collaboration advances NeoStem’s role in the

development and commercialisation of immunomodulatory cellular therapeutic products for the treatment of intractable diseases involving the immune system. Emphasising on the importance of research agreements, Dr Robin L Smith, Chairman and CEO, NeoStem said,“Worldwide, type 1 diabetes affects over 340 million people, and has an economic cost of over $ 174-billion in the US alone. Severe asthma affects another 60 million people. Our collaboration with

Drs Bluestone and Tang, industry leaders in Treg research, and UCSF represents a significant advance in the development of Athelos technology platform.” This collaboration advances NeoStem’s Treg programme towards a clinical phase-2 trial to evaluate the efficacy of autologous Tregs in T1D. NeoStem will manufacture a Treg product consisting of polyclonally expanded Tregs for the planned phase-2 trial to treat patients newly diagnosed with T1D.

16 In Conversation With Hardik Ashar pallavi.mukhopadhyay @network18publishing.com

Modern Pha rm a | 1-15 August 2013

Ayurveda has long been rooted in India but neglected on the research front

…says Dr Muhammed Majeed, Founder and Managing Director, Sami Labs Ltd. An experienced pharmacist-turned-scientist and now, a successful entrepreneur, he is often recognised for taking Indian traditional knowledge to the US from as early as 1990’s. Dr Majeed has been quoted as a ‘step-out migrant’, in a book by Pristone and Hoeffner since he has benefitted both his original and adopted homeland by creating thousands of opportunities. Read on, from an inspiring interaction… Take us through your journey, right from childhood and education to the role today. I was born in a middle-class business family in Kollam, Kerala. I obtained my basic pharmacy education from Kerala. It was in 1975 that I started my journey through the US. In those days, it was not difficult to secure a visa and residency for someone with medical or pharmacy background. Also, I was fluent in English. Before starting with research, I worked with a pharmacy and also, in the pharma industry. My interest was always inclined towards research. So, I joined Long Island University to pursue master’s degree. During the same time, I was fortunate enough to work with Pfizer, Inc. It was a modest red-brick building in the Williamsburg section of Brooklyn, New York that served as an office, laboratory, factory and warehouse. It was the place where Charles Pfizer co-founded Charles Pfizer & Company, a fine-chemicals business. Later, I moved on to get a doctorate in Industrial Pharmacy from St John’s University. This is how I started my career in the US. What were some of the major challenges and hurdles, you had to overcome to reach the position today? By the time I could finish Ph D, I was already working as head of product development at a billion-dollar pharma company, Carter-Wallace, Inc. I decided to move out from the desk job to pursue my entrepreneurial Since, there are many drugs coming dream. I was warned off patent in the next few years, a by my friends and leag ues, who number of leading Indian pharma col suggested continuing companies are looking forward to my well established But I wanted to enter the nutraceuticals market. job. take a risk and try my luck with business. Two years down the line, around late 80’s, I lost all my savings but I was getting a taste of business. These were the days when generics business was taking off in the US, but I knew how activities were delayed with the US FDA. With my research background and knowledge of Ayurveda, I was modern yet traditional. The road to

success has not been smooth but I am glad to have enjoyed the journey. When did you foray into the US nutrition market and how has the industry treated you so far? Ayurveda has long been rooted in India but neglected on the research front. This is where, I got an opportunity and the space to develop and build on knowledge. I believe in do no harm. I started non-toxic studies to convince people in the West about the safety of Ayurvedic products in early 1990’s. Later, I returned to India to establish Sami Labs Ltd. We kick-started with gugulipid, a cholesterol lowering- drug that has been extensively researched by Central Drug Research Institute (CDRI). In 2004, I was chosen by the National Ethnic Coalition of Organisations to receive the prestigious Ellis Island Medal of Honour. Being a CEO of Sabinsa Corporation, the American arm of Sami Group, it was a pleasure to be honoured with the community service. During the same period, Sami Labs created jobs in India as well. This is what has been described as the ‘stepping out of the brain-drain’ instead of ‘brain-drain’. What are the challenges faced by the nutraceuticals industry in India and opportunities ahead? In addition to the vitamins, minerals and the protein powder market, the phytonutrients originating from Ayurveda is also entering the market of nutraceuticals. There is an ongoing debate about the high price of nutraceuticals. India is a price-sensitive market and the current regulation is a mixed pot. Nutraceuticals are now classified as food supplements and governed by the newly constituted, Food Safety Standard Authority of India (FSSAI). It will take time to understand the depth of the problem faced by the industry and the consumer. Also, unsubstantiated claims by many players create credibility problems in this sector. However, opportunities exist. Since, there are many drugs coming off patent in the next few years, a number of leading Indian pharma companies are looking forward to enter the nutraceuticals market.

What differentiates Sami Labs from other players in the Ayurvedic and nutraceuticals sector? We are among the few early starters in this field. Our focus is fixed and built on scientific knowledge. R&D takes the centre stage at Sami Labs. Our philosophy is to nurture innovative ideas with the latest technology. We deploy technology developed at IIT-Bombay. In fact, people call me ‘American’ by 38 years but my heart is here in India. In the US, majority of big brains are from India. With a firm belief in Ayurveda and technology from India, we can make a better scenario. Though we are fundamentally different, sourcing good raw materials has always been a challenge for companies in the herbal space. This will continue in future too. In India, organised cultivation of herbals continues to remain poor. We strive hard to bring the best products keeping social interests in mind. What are the expansion plans? We are rapidly and constantly expanding. We expect a good future business from Sami Direct initiatives. Apart from this, we intend to consider both, green-field and brown-field way of growth. Your advice to aspiring entrepreneurs... Be pat ient , persi stent a nd disciplined. Stay focussed and be willing to work very hard. Remember earning and enjoying should not be your motto. Above all, believe in yourself. Do not get laid down by fallbacks. Learn from fallbacks and keep moving ahead.

OFF THE BEAT Happy moments: Time I spend with my family Interests: Staying abreast with scientific knowledge Cannot live without: Exercise, Yoga and helping out people at large Biggest asset: Our dedicated people/ employees.

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CRAMS in India Nikunj Sharma nikunj.kumar@network18publishing.com

Opening up avenues with regulations

India

Contract Research and Manufacturing Services (CRAMS) is among the fastest growing sectors in the biotechnology and pharma industry. In the past decade, CRAMS witnessed increased interest from the MNCs, in a quest to retain the costs and leverage their profitability. India, with over 175 USFDA-approved manufacturing units, is among the most-sought-after destinations for outsourcing manufacturing services by the global pharma players. he field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and largescale manufacturing facilities. CRAMS has a great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highlyskilled services. Large investments coupled by low productivity in research and development are driving players to reduce the manufacturing expenses through outsourcing the manufacturing and research activities to cheaper nations like India. The entire CRAMS market is split into contract research that contributes $ 1.5 billion and rest 60 per cent is contributed by manufacturing services. India’s CRAMS are mainly into drug discovery, pre-clinical toxicology, API formulations and injectables.

Volatile market According to a report, CRAMS sector witnessed double-digit growth in terms of investments, which was estimated at $ 31.9-billion in 2011. In the next five years, the CRAMS sector is forecast to attain an average growth rate of 12 per cent in terms of revenue annually. CRAMS market for India is projected to grow by 30-50 per cent by 2016, as major drugs worth $ 430-billion of market value losing patents. Outsourcing to India offers several advantages as in comparison *Challenges for CRAMS in India Increasing cost structure (manufacturing costs and labour costs): India is no longer the lowest cost destination for outsourcing companies. Increase in competition from other geographies like China, Taiwan etc Many big pharmaceutical multinational companies (MNCs) are setting up their facilities in India (offshoring). Though India has enforced patent laws, there is still a lingering discomfort among few MNCs, particularly small biotech companies with regard to working in India. In comparison to the western countries, there is still a lot of government control (via licenses) that leads to additional timelines. Focus on Safety, Health and Environment (SHE) is a relatively recent advance, while it is still growing, much greater focus is needed.

to other matured pharma hubs across Europe and North America. Indian CRAM sector has emerged as one of the major low-cost, quality manufacturer of drugs for many global companies and multi-nationals. Also, the current state of economy integrated with the prices and growing market for generics are forcing major players to leverage the strengths of pharma manufacturers in the country. Dr Ruchi Das, Founder and CEO, HealthCursor Consulting Group says, “India is one of the preferred destinations for outsourcing contracts by drug innovators globally due to the product mix being skewed towards high-end research services, biologics and complex technology services at low cost. The country offers an abundant pool of professionals in the area of drug development and research chemistry with large number of pharmacists and post graduates qualifying every year.” Hurdles in the path India offers about 40 per cent of lower operational costs than the western Contract Research Organisations (CROs). Government of India (GoI) also realised the change, which reflected in quick policy amendments in the past decade. In 2005, the biotechnology department launched the patent regime in India to simplify the processes for regulatory approval along with exemption in import duties and service taxes for importing raw material. These initiatives encourage multinational pharma players to outsource in India, which catapulted the CRAMS sector growth in India. However, Intellectual Property Rights (IPR) protection remains a major concern in Asian countries as in comparison to the Eastern European nations. This could lead to IPR violation at times. In this perspective, India is facing challenge from competition countries that include China, Brazil, Russia and Taiwan. Regulators must enforce strict regulatory policies in India to carry out the procedures in an organised manner to ensure timely output over the competitors.

*Demand drivers of CRAMS Global CRAMS is around $60 to $ 70-billion and is estimated to reach $ 90-billion by 2015, of which contract manufacturing constitutes around 65 per cent and contract research 35 per cent. Indian CRAMS business is around $ 3.8-billion. It isestimated to reach $ 8-billion by 2015, with almost the same proportion of contract manufacturing and contract research. Drugs worth $ 90-billion are expected to go off patent from 20112015, while the sales from new approvals are close to replacing the blockbusters. Increasing emphasis on generics alternatives by healthcare policies of developed countries. Global pharmaceutical companies are focussing on marketing and discovery, with outsourcing drug development, clinical trials and manufacturing. Indian companies can also serve as contract marketing partners of MNCs, who want to setup their presence in India. MNCs leverage the marketing and distribution infrastructure of Indian pharmaceutical companies to sell their products in the domestic market. *Recommendation for Indian CRAMS To develop capacity and expertise in areas that shows huge growth potential: Biologics: Increased biologics in the discovery pipeline. Cytotoxic drugs: Increasing oncology discovery stream. Pre-clinical studies: In Vitro and In Vivo studies. Biocatalysis: Increasing emphasis on optically pure drugs, stereo-specific and environmental friendly processes.

Dr Das insists, “As contract research and manufacturing involves outsourcing to a third party, sometimes withdrawal of tax break, inventory rationalisation, over-capacity, patent cliff, lack of regular off-take and adverse currency fluctuations pose challenges for the industry. There is a great deal of regulatory support missing in the ecosystem in India. The authorisation and approval process for pharma companies is cumbersome at one end, where the patent laws are enforced and a great deal of government control via license leads to extended time span. This in turn also, gives rise to tough competition faced by pharma players during the patent protection period. These factors are crippling the industry further.” Looking ahead Going forward, drug producers will invest cautiously in new equipment, technologies and facilities. Choosing an established expert outsourcing destination instead of building, upgrading or expanding their existing in-house infrastructure will catalyse CRAMS in India. To reap the benefits of the outsourcing wave

and overcome the competition in global outsourcing, Indian companies need to contain costs, improve quality and efficiency, and maintain timely delivery. Besides this, the Indian manufacturers must protect the IPR rights of an outsourcing company. “CRAMS industry in India held a huge promise of delivering high growth, a couple of years back. However, issues like cost-cutting in R&D (the current pipelines are not able to compensate for the high R&D investments) and a funding crunch have affected the domestic contract research and manufacturing businesses. Companies involved in CRAMS have slowed down considerably and are awaiting flexibility and support from the Indian Government,” Dr Das suggests. Indian CRAMS need to develop expertise and capacity in potent areas such as inclusion of more biologics and cytotoxic drugs in the research pipeline, in vivo and in vitro preclinical trials and enhanced focus on stereo-specific and optically pure apart from eco-friendly processes in order to establish a robust CRAMS sector across the country.

*Source: Asian Journal of Pharmaceutical and Clinical Research, Res, Vol 6, Suppl 2, 2013, 33-37

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Asia-Pacific market for CRAMS Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Will India surpass China? Increasing pressures have led pharma Multinational Companies (MNCs) to strategically outsource their operations to emerging Asian markets. China and India being strategically positioned countries with booming economies, offer both advantages and disadvantages to the CRAMS sector. Who outpaces the other in the competitive CRAMS market in Asia-Pacific is yet to be seen. hat started as a tactical option has today become a strategic business imperative by large multinational pharmaceutical companies to maintain their profitability in the last two decades. Contract Research and Manufacturing Services (CRAMS) pertains to outsourcing services for Active Pharmaceutical Ingredients (APIs), New chemical entity (NCE) development, finished dosage forms and biologics from low-cost providers with world class standards in line with international regulatory norms. The current global CRAMS market is estimated at $ 70-billion with Compounded Annual Growth Rate (CAGR) of 15 per cent. India’s share in the CRAMS market is estimated at $ 3.9-billion with a CAGR of 30 per cent comprising $ 2.6-billion for manufacturing and the remaining for contract research. With regard to CRAMS in AsiaPacific, India and China are the major players. With renewed interest and increasing focus on Asian giants like India and China, highvoltage growth is undergoing radical changes. While China is streamlining its pharma operations, by supporting the

The global manufacturing capacity for biologics ranks India on the number 4 spot as in comparison to China positioned at number 9. The ﬁrst three positions are occupied by US, Germany and Singapore. Dr Ravi Sobti Independent Pharmaceutical Consultant

development of new products and trying to position itself as a high-quality research destination with sustained government support, India is also becoming an attractive destination as a global outsourcing hub. Looming threats With an increasing population and varied consumer demand, pharma companies are scrambling to enhance their product portfolio and build new R&D hubs in China, thereby increasing their economic advantage and reducing risks. Currently, there is continued investment in Contract Manufacturing Organisations (CROs) in China. With China being known for capacity, volume and good infrastructure, many pharma majors have set up R&D centres in the country. China is recognised as the world’s largest producer of APIs. Among a total of 2,000 APIs in the global market, China has the capability to manufacture 1,600 APIs alone. Also, low cost involved in setting up of manufacturing plants, coupled with a rich clinical and disease resource, large domestic market potential and low drug development costs has positioned China on the global map for expansion of contract research. India is dependent on China for acquiring penicillin and downstream products required for the production of semisynthetic penicillin, cephalosporin and for Androstenedione (AD), which is a key raw material for steroids and hormones. This continued dependence on China for raw materials poses a potential threat on the production cost of the end products. Regulatory noncompliance of Current Good Manufacturing Practice (cGMP) by Indian pharmaceutical majors can affect the credibility of quality products supply with a potential to overthrow India from the top positions. Who grabs the top-spot in Asia-Paciﬁc? The question as to whether India has the potential to surpass China in CRAMS needs a thorough point-by-point analysis. Though, India has several advantages over its Chinese counterpart when it comes to technical skills and manufacturing prowess, the experts opine on the industry going forward.

Dr Ravi Sobti, Independent Pharmaceutical Consultant, elaborates, “India has a distinct advantage with respect to a highlyskilled English speaking technical manpower and a legal system similar to the West. India’s patent legislation confirms to the World Trade Organization’s (WTOs) Intellectual Property Rights (IPR) patent regime. Further, India has 175 USFDA manufacturing plants. This provides for a strong manufacturing base coupled with maximum number of Drug Master Files (DMFs) and Abbreviated New Drug Applications (ANDAs) submitted outside US. India also boasts of technical capabilities in process chemistry, analytical chemistry, operational safety and environmental cleanliness. The global manufacturing capacity for biologics ranks India on the number 4 spot as in comparison to China positioned at number 9. The first three positions are occupied by US, Germany and Singapore.” Hitesh Gajaria, Partner, KPMG India adds, “India’s knowledge on the regulatory landscape in developed markets and technical know-how are well suited for this industry, with a more established GMP regime in comparison to China. It also has an edge in the development of formulations. India is home to nearly 700,000 speciality hospital beds, 221 medical colleges and skilled English speaking medical personnel. These credentials place India in a favourable position to leverage the CRAMS opportunity globally.” The markets going forward… Leading MNCs are making strategic tie-ups to develop biologics with a view of increased capacity. With more APIs going off-patent (eg, $ 29-billion for 2013), India is well positioned to grab a major share of the resulting generics market. With healthcare reforms in US (2010) and increased focus on generics in Europe and Japan, India can aim at an increased share of generics. Gajaria adds, “As healthcare evolves and MNCs begin to move towards biologics and complex molecules, India is bound to benefit. Leading industry players have well structured the biosimilars pipeline. Despite China’s edge in small molecule manufacturing, the complex molecule proposition may help India gain in the coming years. Both economies are well placed

As healthcare evolves and MNCs begin to move towards biologics and complex molecules – India is bound to beneﬁt. Indian companies have already begun focussing on these compounds and leading industry players have well structured the biosimilars pipeline. Hitesh Gajaria Partner KPMG India to leverage the opportunity that is being created owing to the patent cliff.” India has the potential to surpass China, only if it manages to address capacity and infrastructure concerns while maintaining an edge in formulations. The current total export value of Indian manufactured formulations is $ 11-billion. It can also surpass China in most areas of CRAMS, other than antibiotics belonging to semisynthetic penicillin and cephalosporin groups, and steroids wherein it is dependent on supplies from China. Dr Sobti reiterates, “India needs to set up its own commercially viable manufacturing facilities specifically for penicillin and downstream products, and facilities for the manufacture of AD, which is a key to the production of steroids and hormones.” Thus, to surpass China, it is imperative for India to not only be self-sustaining but also strictly adhere to the quality management systems, while maintaining the integrity of data generated and effectively address global regulatory issues. This will help companies to not look up to Europe or US to outsource their drug discovery requirements.

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Challenges for CRAMS in India Anubhav Sharma anubhav.sharma @network18publishing.com

Towards a sustainable business model While the CRAMS sector in India has witnessed exponential growth in the recent times, the industry is heavily reliant on the Chinese counterparts for supply of raw materials, has poor transportation and lack of adequate infrastructure along with logistics concerns pose hurdles to growth. Explore pathways to address these challenges here. n recent years, the pharmaceutical companies have been outsourcing their requirements and services. These companies opt for Contract Research Organisations (CROs) or Contract Manufacturing Organisations (CMOs). The huge costs on R&D are driving these pharma majors to opt for outsourcing services. India is soon becoming the outsourcing hub with many project and service offerings, a tremendous untapped potential for growth of the CRAMS sector in the years to come.

India as an outsourcing hub India has always been economical and cost-effective when it comes to outsourcing services. In India, easy manpower availability at lower costs without compromising on the quality makes this a favourable outsourcing destination for projects in the pharma sector. The country has proved itself in the generics market, where it ranks among the top with Brazil. A similar situation can be observed in the CRAMS sector, which is soon gaining momentum with increasing investments from Multinational Companies (MNCs). “Since 1980s, CRAMS has emerged in the pharmaceutical industry but has gained importance only in the late 1990s, as MNCs were under pressure with the interest on profits,” says Dr Vishal Kumar Gupta, Assistant Professor, Department of Pharmaceutics, JSS College of Pharmacy, Mysore.

Considering India’s expertise in R&D and other manufacturing capabilities, it is the most-sought-after destination for outsourcing by many pharma majors. This led to exponential growth in the CROs and CMOs. Considering the country’s expertise in R&D and other manufacturing capabilities, India is the most-sought-after destination for outsourcing by many pharma majors. This has led to exponential growth in the CROs and CMOs. “The main positive aspects are availability of scientific talent pool, especially

in the area of synthetic organic chemistry, apart from most of them being able to communicate in English better than those in China, that being the closest competitor for this business segment,” says Narendra Kumar Raju, Executive Vice President - Innovation Strategy, Shasun. Furthermore, the Indian legal system is seen to be better than that in China. The momentum started in the clinical trial segment with other areas such as pre-clinical trials and early discovery studies were yet to be explored. India faces competition from China regard exploring potential of these segments. According to experts, while China continues to be questionable regarding quality, India is enjoying glory being positioned as an outsourcing hub. Beneﬁts of CRAMS There are various reasons why big pharmaceutical companies are keen on outsourcing service requirements to India. The most important benefit is the sharing of risks and returns. By outsourcing the services, a company is not only getting the work done at a reasonable rate but is also sharing the risks. Through this approach, a company can reduce the burden and focus on other factors too. Dr Gupta adds, “The big pharma companies can obtain services at low cost since the other players have expertise in those areas. Eventually, the cost of the final product is reduced greatly.” Also companies have no control over their processes but monitor the final product. These companies focus on their core competencies and thus outsource the services to CROs and CMOs. This helps improve focus on the quality of the product and benefits all the companies involved in the process to reap profits. As a positive outcome, these firms then expand and improve their facilities. Challenges faced Though the CRAMS sector is growing at a phenomenal rate, there are numerous problems and challenges. The government has to pay attention to the CRAMS sector, if improvement needs to be witnessed to meet the demand. The problems

of poor transportation and infrastructure create hindrance for the industry in various ways. “The visible challenges are poor transportation infrastructure, moderate supply chain, low-cost Chinese CRAMS industry, over dependency on China for raw materials and movement of talent pool from West to China compared to India,” adds Raju. Dr Gupta emphasises, “There is no proper regulation for the CRAMS sector. This lack of control is causing vicious circle and leads to poor quality, dishonesty towards work, etc.” Some of the other challenges as stated by Dr Gupta include, intellectual property right risk, outsourcing risk and capacity concern. Elaborating on the causes, Raju says, “One high risk factor is an element of overdependency on China from the Indian players for raw materials. Red dragon has strong infrastructure, and it has been providing additional support to pharmaceutical companies in China.” Due to this dependency, the raw material used in the CRAMS sector in India is similar to those used by the Chinese pharma players. Thus, achieving the global quality levels becomes difficult. Furthermore, Raju says, “The logistics constraints and delays in bringing the procured raw materials back to India also result in additional loss of time and money.” While the CRAMS sector in China has the distinct advantage of ease of access to raw materials at lower costs, which gives them an upper hand over their counterparts in other geographies. “China has been considered as one of the major competitors for India in the CRAMS business and the dependence for raw materials by the Indian CRAMS industry on China, is a major issue that might hinder the growth of the Indian CRAMS industry,” Raju explains. The increasing costs involved in ensuring high standard infrastructure and human resource for the R&D and manufacturing facilities as per the international guidelines is adding up to the trouble. This has been pushing the CRAMS

There is no proper regulation for the CRAMS sector. This lack of control is causing a vicious circle and leads to poor quality, dishonesty towards work, etc. Dr Vishal Kumar Gupta Assistant Professor, Department of Pharmaceutics, JSS College of Pharmacy (Mysore) industry in India to spend more in comparison to the Chinese counterparts. Combating the change In the recent past, India has been recognised for its potential in the field of pharmaceuticals and Information Technology (IT). Despite this, there seems to be little advantage for the Indian CRAMS sector. Raju avers, “It is high time that these issues are specifically identified and taken up by the Indian government authorities in close collaboration with the Indian CRAMS industry to ensure further prospective growth in the near future.” Dr Gupta reiterates, “The government should pay attention to the proper regulation of the segment. Despite proper law and rules, the industry can never flourish and we will face the same challenges in the years to come.” If the CRAMS sector in the country has to evolve with the changing times, while meeting demands, it is required that the industry be governed by stringent laws and regulations, amended from time to time to accelerate the growth momentum.

Special Focus -Interface Nikunj Sharma nikunj.kumar@network18publishing.com

M odern Pha rm a | 1-15 August 2013

Cost effectiveness, access to technology and quality services will be the key drivers for growth of CRAMS How do you visualise the growth of CRAMS in India? Contract Research and Manufacturing Services (CRAMS) is one of the fastest growing segments in the pharmaceutical and biotechnology industry. It pertains to outsourcing the entire supply chain from drug discovery to development and manufacturing products to low-cost providers with world-class standards, in line with the international regulatory norms. Global market of CRAMS (excluding clinical trials) is estimated in the range of $ 80 - 90 billion with a CAGR of 12 per cent. The manufacturing activities account for nearly 65 per cent and the remaining for contract research. India’s share is estimated at around $ 3.8-billion with a CAGR of 30 per cent, which is nearly 5 per cent of the global CRAMS market. Thus, there is a substantial potential for India to grow in this segment.

What could be the sustainable future model for CRAMS industry in India? The sustainable model for CRAMS in the pharmaceutical and biotechnology industry has to be focussed on customer needs taking into account the strict compliance of regulations as per International Conference on Harmonisation (ICH) guidelines, constant upgradation of quality management systems, cost-effectiveness, supply chain, project management and technology upgradation aimed at energy conservation, increase in productivity and waste minimisation with ongoing training of employees to keep them abreast of the regulatory compliance and improvising them through strategic alliances with global biotechnology companies. What will be the demand drivers for CRAMS sector in the next ﬁve years? The most important key driver is cost saving potential, access to technology, equipment and highly-skilled manpower,

…says Dr Ravi Sobti, an Independent pharmaceutical consultant, highlighting different checkpoints that act as growth drivers for the CRAMS sector in India. Contract Research and Manufacturing Services (CRAMS) market in India needs to adopt improvised practices and models in order to sustain the expected growth rate.

without compromising on quality or regulatory aspects. The following support: Low manufacturing cost Economic downturn has resulted in transition of business model of major pharmaceutical companies, from a model wherein they performed all functions such as drug discovery to distribution and sales, to the one that involves collaborative networking to maintain profitability. Increased penetration of generics in the regulated markets. Increase in number of drugs going off patent resulting in new generic drugs entering the market. Increasing capabilities in biologics Are Indian CRAMS well-equipped to take up challenges? Most of the major Indian pharmaceutical companies having USFDA manufacturing plants and Drug Master Files (DMFs) are fully equipped to deliver quality products on time. Lately, there have been some instances where Current Good Manufacturing Practice (cGMP) violations have been notified by the regulators of pharma majors. In such cases, on rectification of the shortcomings, permission for outsourcing from these plants is allowed. Pharmaceutical companies complying with regulatory norms, as per international standards, are fully equipped to accept challenges of the regulated markets.

Insight & Outlook-Interface

Hardik Ashar pallavi.mukhopadhyay @network18publishing.com

Modern Pha rm a | 1-15 August 2013

To foster mutual growth of the industry, we require conducive business environment Tell us about the life science markets in Australia. The Australian pharmaceutical industry is dynamic in nature, comprising many originator and few generic companies, some small-scale core biotechnology companies as well. Australia exports pharmaceutical products worth more than $ 5 billion and ranks in the top 20 spot of the world pharma market. However, there are huge imports as well. On the pharma manufacturing front, it accounts for approximately 1 per cent of total manufacturing workforce. We are considered as leaders in biotechnology. This industry has built strong international alliances with partnering on primary research and commercialisation. What are your offerings for India? We are in talks with some Indian companies for developing small molecules. The company has its strength in small molecule drug discovery, drug design, medicinal

chemistry, computational chemistry and structural biology. India has complementary skill sets namely, cost effective drug development, ability to scale up and commercialise. So, in this way we can mutually contribute to new product development. What are your expectations from the government and industry bodies? I happen to be on board of various governmental bodies in Australia. The business timelines in biotech and pharma are approximately 7-10 years, much different from those in other business models and investors get nervous by such long-sighted plans. It is time when we require government to play a role in the strategic processes. To foster mutual growth of the industry, we require conducive business environment. Support for strategic activities, fostered investments, facilitation of interactions and alliances are some of the expectations from team India.

…says Dr Andrew Wilks, Executive Chairman, SYNthesis Med Chem, Australia. While on a trade mission to India, he informs about the life science opportunities in the swift moving and rapidly progressing markets of India, Australia and China.

Can you shed light ‘with a third-party perspective’ on the competitive scenario between India and China? Pharmaceutical industry in the West is in a state of flux, while emerging markets such as India and China are attracting huge attention for driving businesses. Both economy giants, recognised globally are competing. Fortunately, I had an opportunity to work closely with both these countries. In China, there is strong support for the early stages of drug discovery, clinical trials and patent, while India is home to global generics manufacturing and back process chemistry. Currently, R&D investment in India is achieving new heights. Also, India has an unique advantage of low cost and high quality. The biopharmaceutical sector is among the fastest growing knowledge-based sectors in India and is expected to play a key role in shaping the country’s progressive economy. Investments, along with outsourcing activities and exports are key drivers of this sector. Many experienced professionals are moving towards India and China. Thus, providing easy access to a great talent pool. Many companies are tapping the enormous talent potental and offering great career opportunities.

Inside & Outlook: Automation Trends

M odern Pha rm a | 1-15 August 2013

IT-based automation in pharma

Bejon Misra Founder, Partnership for Safe Medicines (PSM-I) India Initiative bejonmisra@consumerconexion.org

Modern informat ion technology could be used in an extensive manner for this purpose. In addition to the scientific and technological measures, it must be emphasised that there is a need to strengthen the existing monitoring mechanisms, to upgrade and modernise the drug testing laboratories. The latter should be provided with state-of-theart technologies to sensitively and speedily test the samples sent to them for analysis. This would require equipments like mass spectrometers and others, along with training of personnel, within the country and if required, even abroad, to utilise the modern facilities to their optimum capacity. There is a need to create centralised â&#x20AC;&#x2DC;databaseâ&#x20AC;&#x2122; of all drug and drug manufacturing units in the country, which could help trace the origin of a drug (e-pedigree) through the entire supply chain. Simultaneously, there is a need to streamline the law enforcement system, as already proposed by the Mashelkar Committee in 2003 and the Parliament of India recently.

26 Energy Management

Modern Pha rm a | 1-15 August 2013

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Renewable energy sources

How can the pharma industry beneﬁt?

Staying ahead in the business requires not just innovative ideas but also cost-effective energy solutions. Pharma companies are incorporating design and operational changes in their facilities to remain global players. With renewable energy sources trending in the market, companies are now looking to revamp operations by making use of these freely available alternative energy sources. ith growing scarcity of natural minerals and ores, rising prices of coal and petroleum, uncertainities associated with the supply, global warming concerns, and utilisation of renewable energy sources have become the next best solution to perk up a company’s environmental profile. In recent times, the role of new and renewable energy will see increasing importance due to the emerging concern regard country’s energy security. Vast availability of solar and wind power, one-time installation cost, little need for maintenance, no fuel use and green pricing programmes have propelled the installation of solar panels and wind mills across the globe. These sources of renewable energy are green and have the potential of viable replication across various industry sectors. Amid increasing concerns over reducing the country’s carbon footprint, the recently rechristened Ministry of New and Renewable Energy (MNRE) has been formulating and implementing policies and programmes for the development

India’s National Solar Mission target is 15-million m2 of solar thermal collector area by 2017, and 20-million m2 by 2020. The thermal energy applications in pharmaceutical units require low-range temperatures that are easily achievable by solar energy applications. and sustenance of new and renewable energy. With a vision to develop new and renewable energy technologies, processes, materials, components, subsystems, products and services at par with international specifications, standards and performance parameters, MNRE is furthering their goal in combating the peril of climatic change and global warming. Renew: The new mantra With renewable energy sales picking up and building

The cost of generating solar power is currently high, but will reach parity by 2020 and will match the costs of thermal power. In India, renewable energy will constitute 3-4 per cent of the total energy generation by 2020. Rajiv Rao Sales Director, Base & Performance Chemicals, South Asia, Dow Chemical International Pvt Ltd excitement in the market, India is taking on a number of energy projects. Rajiv Rao, Sales Director, Base & Performance Chemicals, South Asia, Dow Chemical International Pvt Ltd, says, “The cost of generating solar power is currently high, but will reach parity by 2020 and will match the costs of thermal power. While wind energy costs are still lower than solar energy, there is an over capacity of windmill production and its capacity needs to be consolidated. Currently, Germany and China are leaders in solar energy and wind energy, respectively. However, in India, renewable energy will constitute 3-4 per cent of the total energy generation by 2020.” Keeping in line with the need of the hour, many industries are replacing conventional sources of energy with renewable energy. The pharmaceutical sector is also taking cue and looking at commercially feasible solutions for energy conservation.

Major pharma companies such as Lupin have been actively pursuing all available alternative energy supply options to optimise their operations. Commenting on this, Rajendra B Chunodkar, Executive VP, Technical, Lupin Ltd, says, “Lupin is pursuing alternative energy options such as wind mills and solar energy. We have installed solar cells for hot water generation. Our windmill project is in its late stage of negotiation. However, India needs to bring down the capital expenditure cost per kW as it is high and we are unable to compete with conventional energy tariffs offered by other countries.” Heading the solar way India’s National Solar Mission target is 15-million m2 of solar thermal collector area by 2017, and 20-million m2 by 2020. According to various reports, pharmaceutical industries utilise both electrical and thermal energy through several stages of their processes, the scope of switching some of the operations to solar power applications is a suitable option. Most of the thermal energy applications in pharmaceutical units require low-range temperatures that are easily achievable by solar energy applications. Various research studies have shown that facility design changes within the pharma laboratories can serve as technically practicable options. As many processes in pharmaceutical industries use steam, installing solar water systems can be used to heat the boiler makeup water and thereby replace part of the existing fuel use. Field studies have revealed that units in the pharma sector have insufficient free space for installing solar applications because of the exhaustive utility piping network on the roofs. Cutting costs Capital expenditure is preventing pharma industry from exploring alternate energy sources. Chunodkar adds, “The pharma industry is utilising

available energy most effectively by cutting down costs in distribution and consumption. Pharma companies can start maintaining an efficient header network, cut down losses by closely placing generation and consumption, opt for distributed rather than centralised generation. Other effective measures include utilising alternative energy supply instead of steam for heating operations, steam condensate recoveries, multiple effect evaporators to reduce steam consumption. Opting for energy efficient agitation systems, centrifugal and screw compressors for chilling, lighting systems and aeration systems in effluent treatment

The pharma industry is utilising available energy most effectively by cutting down costs in distribution and consumption. Rajendra B Chunodkar Executive Vice-President, Technical, Lupin Ltd plants is another alternative. Also, selecting pumps to suit exact heads and higher efficiency could help cutting operational costs.” Thus, the pharma industry is taking small steps to cross over to the greener side. Cost cutting will eventually help the companies manufacture indigenously develop products and advance the national goal of energy safety and security.

Technology Transfer

M odern Pha rm a | 1-15 August 2013

As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration.

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,l’-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing Anti-ulcerative APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy

Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater. Areas of application Biotechnology, engineering Forms of transfer Consultancy Calcium gluconate A company needs technology for manufacturing of calcium gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others Extract of medicinal and aromatic plants A company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal

and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others IV fluid manufacturing as SME An Indian company needs new and good technology to start, which is a subservient of genetic manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. Areas of application Medical research Transfer terms Others

Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterised in producing, Urease on its one end and to a voltage measuring device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Formulation for leucoderma It is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application Pharma and medical industry Transfer terms Joint venture, technology licensing, research partnerships

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, Asian and Paciﬁc Centre for Transfer of Technology (APCTT) of United Nations Economic and Social Commission for Asia and the Paciﬁc (UNESCAP), APCTT Building, C-2, Qutab Institutional Area, New Delhi – 110 016, India. Tel: +91-11-3097 3758 (Direct), +91-11-3097 3710 (Board), Fax: +91-11-2685 6274 E-mail: srinivasaraghavan@un.org, Web: www. apctt.org. For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

28 Projects

Modern Pha rm a | 1-15 August 2013

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/lifesciences industry. Capsule polishing machine Project type New facility Project news ACG Pam Pharma Technologies Pvt Ltd is planning to set up a new project for manufacturing plant and machinery at Greater Mumbai, Maharashtra .The project involves manufacture of capsule polishing machines. Project location Greater Mumbai, Maharashtra Project cost NA Implementation stage Planning Contact details: ACG Worldwide Dalamal House, Nariman Point, Mumbai - 400 021, Maharashtra Tel: +91-22-3008 9444 / 45 Fax: + 91-22-2287 2560 Email: info@acg-world.com

New product manufacturing unit of Men - Tsee - Khang Project type New facility Project news The project entails construction of a new product manufacturing department and procurement of new equipment and machinery. The project intends to increase production capacity through the construction of a new product manufacturing facility by creating a sustainable social enterprise model. It also plans to contribute to the economic growth of the Tibetan community through increased employment, social welfare programs and ongoing contributions to other Tibetan organisations. To continue to meet the needs of patients receiving treatment throughout India and elsewhere, by meeting the growing demands of our national branch clinics. Project location Bengaluru, Karnataka

Project cost ` 121,634,069 Implementation stage Planning

have the capacity to produce 2.5 billion paracetamol tablets a year. This will boost the Sri Lanka’s domestic manufacturing sector and help stabilise prices.

Contact details: Men-Tsee-Khang (Tibetan Medical & Astro Institute) Gangchen Kyishong, Dharamsala-176215 District Kangra, Himachal Pradesh, India Tel: +91-1892-223113/223222 Fax: +91-1892-224116 Email: info@men-tsee-khang.org --------------------------------------------------

Project location Moratuwa, Sri Lanka Project cost NA Implementation stage Planning

Paracetamol tablets manufacturing facility in Sri Lanka Project type New Facility Project news GlaxoSmithKline is due to open a newlybuilt manufacturing facility in Sri Lanka, which is said to be the ﬁrst solid oral dose facility set up by a multinational ﬁrm in the country. Plant in Moratuwa will

Contact details: Glaxosmithkline Pharmaceuticals Ltd 121 Galle Road, Kaldemulla Moratuwa Sri Lanka Tel: +94 -11-2636341 / 2 Fax: +94 -11-2635000 --------------------------------------------------

Pharmaceutical plant in Gujarat Project type New facility Project news Set up pharmaceuticals plant in Gujarat Project location Ahmedabad, Gujarat Project cost ` 100-crore Implementation stage Planning Contact details: Troikaa Pharmaceuticals Ltd Thol, District Mehsana -382728, Gujarat Tel: 02764-274304, 274326, 274475, 274353 Fax: 02764-274684 Email: dehradun@troikaapharma.com --------------------------------------------------

Strengthening Pharmaceutical Systems Afghanistan Associate Award Project Project type New facility Project news The SPS Afghanistan Associate Award Project is working to help Afghans throughout the health system work within existing systems and constraints to strengthen their pharmaceutical sector for lasting health impact. The project work bolsters Afghanistan’s Ministry of Public Health (MoPH) and its agencies, the entities critical to a healthy populace but long being neglected due to decades of war. Project location Afghanistan Project cost NA Implementation stage Planning Contact details: Management Sciences for Health 784 Memorial Drive Cambridge, Massachusetts 02139, USA Tel: +617-250-9500 Fax: +617-250-9090

Information courtesy: www.tendersinfo.com

1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067, Maharashtra, India Tel: +91 22 28666134 Fax: +91-22-28013817 Email: parmeet.d@tendersinfo.com

Tenders

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: Defence Research and Development Organisation (DRDO)

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Optical emission spectrometer Org

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: National Dairy Research Institute (NDRI)

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spectrophotometer. BOD : 07 August, 2013

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Modern Pha rm a | 1-15 August

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photoluminescence

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Org

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Gamma system spectrometer

and Research (NIPER)

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Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type Information courtesy: www.tendersinfo.com

1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067, Maharashtra, India Tel: +91 22 28666134 Fax: +91-22-28013817 Email: parmeet.d@tendersinfo.com

Event List

Modern Pha rm a | 1-15 August 2013

National Events

International Events

PHARMAbiotika Pharmabiotika 2013 is an exhibition that facilitate buyer and seller meet to network with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives; September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar

3rd International Conference on Environmental, Biomedical and Biotechnology This conference is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society. It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore

For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 â&#x20AC;&#x201C; 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com Indian Pharma Expo The Indian Pharma Expo 2013 will serve as a perfect platform for pharma entrepreneurs and investors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and suppliers and distributors of pharma products under one roof to exchange ideas; September 20-21, 2013, Pragati Maidan, New Delhi For details contact: UBM Medica India Pvt Ltd Tel: +91-22-66122600 / 66122673 Fax: +91-22-66122626 Email: info.india@ubm.com Website: www.ubmindia.in Asia-Arvo Some of the primary highlights of this conference will be interactive session, papers, abstracts and programme. Masses from all over the world are welcome to be part of this conference. Topics that will be discussed in Asia Arvo include genetics of AMD, understanding AMD, reprogramming and regeneration, gene therapy, small molecule screening and drug discovery, model organisms, gene regulation during development and disease, eye development inherited eye diseases, diabetic retinopathy, common eye diseases, signaling pathways, angiogenesis, crystallins, chaperons and heat shock proteins, oxidative stress, ageing and eye disease; October 28-31, 2013, Ashok Convention Centre, New Delhi For details contact: The Association for Research in Vision and Ophthalmology Tel: +12402212900 Fax: +12402210370 Website: www.arvo.org CPhI India CPhI India will bring pharma professionals from all over the world to Mumbai and facilitate, initiate and close business deals. It will be a great opportunity for the industry toÂ showcase their products and services while enhancing their brand at South Asiaâ&#x20AC;&#x2122;s leading pharma industry event. Exhibitors will include manufacturers

of Active Pharmaceutical Ingredients, Alkaloids, Amino acids, Antibiotics, Antibodies, Antimicrobial preservatives, Antioxidants, Biocatalysts, Biotechnology, Capsules/encapsulation, Chemical synthesis/analysis, Chira intermediates and lots more; December 3-5, 2013, Bombay Exhibition Centre, Mumbai For details contact: International UBMÂ Live Tel: +91-22-67692415 Fax: +91-22- 66122626 / 66122627 Email: vikram.rao@ubm.com Website: www.pmec-india.com P-MEC India With Indiaâ&#x20AC;&#x2122;s pharmaceutical machinery and equipment market growing, decision makers from all over the world are increasingly looking at India for sourcing pharmaceutical machinery and equipment. At P-MEC India, visitors will have the unique opportunity to showcase their products in front a large audience, building brand awareness and gaining new leads from over 85 countries. P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide - the â&#x20AC;&#x2DC;must attendâ&#x20AC;&#x2122; event in the international pharmaceutical industry. It is a great platform for visitors to showcase high-quality pharma machinery and equipment, meet with key decision makers in pharmaceutical industry from countries, including India, China, US, UK, France, Italy, etc and network and build the brand in one of the worldâ&#x20AC;&#x2122;s fastest growing pharmaceutical markets; December 3-5, 2013, Bombay Exhibition Centre, Mumbai

For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society Tel: +86-28-86528465 (China Branch) Email: cebb@cbees.org Website: www.icebb.org Fifth Annual Consumer Genetics Conference The conference will draw together a dynamic community of scientists, clinicians, technology innovators, and patients to discuss the burning issues around the analysis and delivery of genomics results directly to patients and consumers. Attendees will hear about disruptive diagnostic technologies, cognitive barriers to patients and medical professionals, ethical, regulatory, privacy issues, the issue of reimbursement, and the challenges of building relationships to realise the potential of personal genomics and individualised medicine. CGC will provide an opportunity for all stakeholders to come together at one venue, share viewpoints and engage in dialogue; September 25-27, 2013, Seaport Hotel, Boston, USA

all over the globe; October 14-16, 2013, Brisbane Convention and Exhibition Centre, Brisbane, Australia For details contact: Ozaccom+ Conference Service Tel : +61 (0)7 3854 1611 Fax: +61 (0)7 3854 1507 Email:Â gds13@ozaccom.com.au Website: www.gds2013.org Drug Discovery Re-Invented: Emerging Role of Biotechs, Academics and Non-ProďŹ ts The conference will center on new approaches to drug discovery in an industry where the landscape is changing rapidly. With large pharma reducing investment in internal early stage research, drug pipelines will increasingly be filled by alternative sources. These players include: government, academic labs, non-profits, biotech companies, and pharmaceutical â&#x20AC;&#x153;open innovationâ&#x20AC;? models. The conference will also provide examples of successful strategies for advancing new drug candidates in this era of distributed discovery; October 16â&#x20AC;&#x201C;19, 2013, Hilton Scottsdale Resort & Villas, Scottsdale, Arizona, USA For details contact: Fusion Conferences Tel: +44 (0) 1638 724137 Fax: +44 (0) 1638 724135 Email: admin@fusion-conferences.com Website: www.fusion-conferences.com

5th Pan Arab Human Genetics Conference The conference will focus on topics ranging from cancer genomics and For details contact: NexGen sequencing to molecular International UBMÂ Live profiling and pharmacogenomics. Tel: +91-22-67692415 International and regional experts will Fax: +91-22- 66122626 / 66122627 take to the platform to deliver their Email: vikram.rao@ubm.com lectures on these topics. Researchers Website: www.pmec-india.com For details contact: will be encouraged to submit 34th International Conference Illumina their abstracts for oral or poster on Bioscience, Biochemical and Tel: 781-972-1359 presentation at the conference. Also, Email: jay@consumer-genetics-conference.comÂ Â a special feature of the conference Pharmaceutical Engineering The main focus of this conference Website: www.consumergeneticsconference.com will be a workshop on rare disorders; is to bring scientists, researchers November 17-19, 2013, Al Bustan and scholars together to exchange 4th Global Drug Safety Rotana, Dubai, UAE and share experiences and research Conference and Exposition results about bioscience, biochemical The 4th Global Drug Safety Conference For details contact: and pharmaceutical engineering, and Exposition will be based on the Meeting Minds Experts and discuss the practical challenges theme,Â â&#x20AC;&#x2DC;Revitalising Drug Safety â&#x20AC;&#x201C; The Tel: +9714-4270492 encountered and the solutions Decade of the Patient.â&#x20AC;&#x2122; Drug safety has Fax: +9714-4270493 adopted. The conference will deal with become one of the most challenging public Email: pco@pahgc.org topics such as bioscience, biochemical health issues of this time. It is everyoneâ&#x20AC;&#x2122;s Website: www.pahgc.org and pharmaceutical engineering, responsibility to take action to address affective neuroscience, astrobiology; the serious threat to global public health 2013 International December 5-6, 2013, Sheraton, posed by the pressing issues relating to Conference on Pharmaceutical unsafe medicines and the unsafe use and Biological Sciences Bengaluru of medicines. The exposition will bring The aim of the International together government leaders, drug Conference on Pharmaceutical and For details contact: World Academy of Science Engineering regulatory agencies, drug safety specialists, Biological Sciences is to provide a healthcare professionals, pharmaceutical platform for researchers, engineers, and Technology industry, healthcare technology providers, academicians as well as industrial Tel: +44-782-4879405 health insurance providers, patient safety professionals from all over the Website: www.waset.org/ advocates, and consumer groups from world to present their research conferences/2013/bangalore/icbbpe/ results and development activities in pharmaceutical and biological Sciences; LUDHIANA PUNE CHENNAI JAIPUR Punjab Maharashtra Tamil Nadu Rajasthan November 17-18, 2013, Cristal Hotels October 18-21, 2013 November 14-17, 2013 Nov 29 - Dec 02, 2013 December 20-23, 2013 & Resorts, Abu Dhabi, UAE. Indiaâ&#x20AC;&#x2122;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.

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Book Review

Modern Pha rm a | 1-15 August 2013

Clinical Data Management

Laws relating to Drugs and Cosmetics, 23rd Edition Editor: Vijay Malik Price: ` 1,650

Publisher: Eastern Book Company 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

linical data is the most important set of data generated by clinicians, investigators, pharmaceutical companies and analysts that can shape the clinical policy, manufacturing policy and drug policy in general. With the advent of the clinical research industry, the planning, generation, and interpretation of data have received particular attention. The editors have compiled a fantastic book covering all the aspects of modern clinical data handling, together to bring chapters from renowned experts in this field and drawn a compilation in the form of a textbook on clinical data. The book begins with emphasis on the importance of the International Conference on Harmonisation (ICH) in todayâ&#x20AC;&#x2122;s world of international trade and the role of Clinical Research Organisations (CROs) and clinical data on the same. The next couple of chapters discuss Case Report Form (CRF) designing and data capture, with particular stress on electronic systems and remote data capture. The use of Optical Character Recognition (OCR) and Image Character Recognition (ICR) is also discussed in detail. The chapters further deal with planning and implementation of clinical trial and various aspects of the same, validation of data generated in a trial, quality assurance, data presentation and measuring performance. The book also dedicates a special set of chapters to innovations in clinical data management such as databases for large laboratories, types of computer systems and their validation, data management in epidemiology, etc. The chapter on working with CROs is an interesting read. Overall, this is a great book for those dealing with clinical data.

f there was any book, which would compile every piece of legislation related to the pharmaceutical industry and allied health professionals, then this is it. This book enlists all the original acts along with their amendments both state and central. The notable addition is the relatively new Drug Price Control Order (DPCO), 2013. The book covers majorly, the drugs and cosmetics act, 1940, and the drugs and cosmetics rules, 1945, along with their subsequent amendments. The allied healthcare industry is also represented by the Clinical Establishment Act, Bio-Medical Waste Rules, Medical Termination of Pregnancy Act (MTP) and regulations and the Pre-natal Diagnostic Techniques (PNDT) rules of 1996. In addition to the major acts, the book also compiles numerous government circulars, schemes and ordinances passed from time to time. The entire content with additional updates is also available in a CD format along with the book. It is a must-have book for every individual in the pharmaceutical industry, doctors, clinical establishments, importers, exporters, and contract research organisations, corporate lawyers, NGOs and others.

Editors: Richard K Rondel, Sheils A Varley and Colin F Webb Price: ` 3, 195

Publisher: Wiley 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

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

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In Convers ation With 14

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Misra President - Staffin g Randstad India

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It 25 consideration at least shareh Financ e Ministr tions and taken l. â&#x20AC;&#x153;FIPB has consid medicines branded SEBI guidelin crore to meet market been asked olding and promo25 per cent decisio ns ered es. regulator, broad range and products OTC on merit,â&#x20AC;? The FIPB y stated . The compa cent or belowto lower their stake ters have the nyâ&#x20AC;&#x2122;s parent Depart ment is headed by Pharmaceuti of customers,â&#x20AC;? to a to 75 per 4,54,205 by June, Novartis AG Arvind Elder 2013. shares in To help has sold Investm ent of Econom ic Affairs Mayara m, Secret the Bomb cals said in a the amount of compa nies filing the new ay Stock (FDI) propos ary, . Thirty ` 25.45 crore,company for a total 10 from the Foreig n public shareh compl y with als This acquis Exchange (BSE)to in a filing Direct SEBI pharm a sector. were being discuss to BSE. 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Dr Monica

Dean, Lovely Gulati Professional University nformation technology practices and operational (IT) has sectors and pharmacy proceduresrevolutionised other professional the working in almost is not an and staying exception all the corporate developing abreast of the stream calls for to it. Pharmacy, regular a developingat a faster rate relevant recent upgradation like any innovations. because of knowledge country medical of proliferation Medical knowhow, like India, where we sciences in research sciences are through IT can play a pivotal lack enough resourcesactivities. virtual Also, the role in In convergence space. spreading to dispense has led the pharmaceutical to of pharmacy reduced new vistas of medications, sciences and to have come minimal and where human information automatic/mechanised to fore. also an interventiontechnology area, where Networking aspects to come. has IT is poised amongst pharmacy of treatment been to play While, a predominantservice providers that prominent in emerging global is role in the times diagnosing markets, IT pharma chains is now are diseases thereby advancing opting for in the raising to become franchisees possibilities preliminary basis. In stages capable view of of taking remedial of their evolution,of all actions IT is bound these aspects, on a timely it to play a major can be stated the pharma role in developingthat skills virtual through space.

Shyamal

VP-Business Kalani Development,

Oasis Test House Ltd he Indian revision system of pharmacy and improvement. education updated as per The existing lacks focus pace with orientation and the current industry curriculum on curriculum training is old and trends. pharmacy the changing makes The lack trends not it of practical most of colleges is limited of the industry.difficult for which have only to Practical the students to can help a fixed education keep bridge this little or no relevance number education of laboratory imparted gap by to the current in space. There offering experiments, while bearing quality industry is training in mind a dire need to practices. modules The pharmaceutical upgrade the latest IT developments and modernisein the pharmacy have to be consistent education today the curriculum, in need to needs a the pharmaceutical with acquaint new outlook industry. the studentsthe emerging laboratory technology. and fundamentals with the management management There latest systems solutions (LIMS), trends in industry is an immediate (CRM), (ERP), sales customer resource planningautomation like the pharmacyforce automation relationship and solutions management business information graduates to understand, (SFA) etc. systems systems It is important The students through update query, report, and maintain for latest regulatoryalso need and use to be exposed and analysepharmacy systems, quality and taught the data. assurance, validations, related activities. quality control clinical research,about the and R&D

Nikunj

Sharma nikunj.kumar@network18publishing.com

ion and exposure and educationists to need to ing new revamp IT too

Narendra

Nayak Director & Account General Manager, CSC India he pharma data analysisindustry has always relied exponential as a part of the regulatoryon information rise in data is population, systems approval changing Electronic and process. the scope radically. With the research. Medical Record For example, and usage CSC is closely (EMR) systems the patient of healthcare to extract are a vital and analyse working with records held in Moving the University source for clinical in-depth beyond traditional data for this Hospital, clinical trials and and Southampton,UK purpose. models an important significantly of data, broader part of to identify gamut of â&#x20AC;&#x2DC;Big Dataâ&#x20AC;&#x2122; techniques, the therapeutic available applied companies requirements, patient process for design data are itself. Data will move large populations becoming beyond therapies and predict analysis is being and begin creating â&#x20AC;&#x2DC;blockbusterâ&#x20AC;&#x2122; With the medical used needs. to volume for all different Pharma and velocity deliver personalised medicines, of data organisations sets. We therapies. applicable to believe involved involved, we believe access to that t to maintain it po their own is impractical will eventually l health data brokers discrete data be the way forward. space, offered providing With pharma companies as-a-service ment of therapies focussing and not e foresee analytics vice.

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Dr Dhanlakshmi

Director,

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ndeniably education for the appropriate system, upgradations IT is whatnexus between various in the software we can pillars potential devised by masterminds, arena and bank upon. With of advanced to fill in evolving continuous all lapses the With IT and lacunae evolving technology innovative technologies in limelight to be at with regards now, sector par institutions. with the rising the existing syllabus to skillsets has tremendous of an individual. The academic demands needs acumen and expectationsto be modified for system periodically, also introduce various industry from in-house oriented lacks skilled industry industry and soft tools practical jobs that representatives other exists.. Also, training include exam or IT managementA state pharmacycurriculum with provide facility councils with some monetary profession. need to While on for continued pharmacydo not conduct benefits also not the other and recognised at par education hand, the for registration entrance sector also to provide an insight to students-industry-regulatory lacks in to join the the pharmacy industry adequate for interaction sponsorships/scholarship graduates. frequent the meritorious is Pharma students. u programmes education The technical all, the newly from teaching gradu the innovation modes are the not in quot students are feeling of under psycholo unemployment.

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Products

M odern Pha rm a | 1-15 August 2013

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 Colloid mill

Dispensing and sampling isolator

Colloid mill is an ideal and perfect homogenisercum-emulsiﬁer. It ﬁnds application in various processes like grinding, homogenising, emulsifying, dispersing, mixing, extracting, etc. Outstanding and rigid design criteria combined with excellent quality of workmanship of colloid mill automatically ensures superior end product. It is suitable for small, medium, as well as large batches of production. It requires very low maintenance, longer working life and high performance. Application industries are pharmaceutical industry, food, dairy, sweetmeats & confectionery industry, chemical industry, paint industry, textile industry, cosmetic & detergent industry, rubber industry, sausage production & meat packing industry, starch & paper industry.

Dispensing and sampling isolator is specifically designed for laboratories, clinical trials and production facilities. It can accommodate pharmaceutical containers of all size and achieve maximum containment levels. Optimum operator safety and protection is assured at all times during the dispensing and sampling process through the use of advanced system. The benefits in using the dispensing and sampling glovebox are analysis of work flows including assessing ergonomics and functionality, interface with interconnecting systems – determining powder handling through split valves, airlocks, rapid transfer ports (RTPs) and bag-out ports, completely integrated design including hoists, weigh systems, transfer devices, clean-in-place (CIP) and safety, 3D models, full scale mock-ups, assured containment to nanogram levels, total expertise from an original containment pioneer and precision built systems designed for longevity.

Jay Pharma Equipments Mumbai - Maharashtra Tel: 022 - 32155790 Email: jkpharm1@gmail.com Website: www.jaypharmaequipments.com

PSL India Mumbai - Maharashtra Tel: 022 28908232 Email: salesindia@powdersystems.com Website: www.powdersystems.com

Enviro Technologies Thane - Maharashtra Tel: 022 - 64646500 Email: ankit.s@enviroworld.in Website: www.enviroworld.in

Laminar airﬂow cabinet

Bacteriological Incubator

The laminar airflow cabinet is used for work with lowrisk substances and materials, when protection of working material from environment is required or work with item requires a sterile working zone. Cabinet is also used for equipment of local workplaces in medical, pharmaceutical and other institutes with high requirements for air cleanliness in the working zone. The company can design the control system for laminar air flow cabinet as per customised specification. Some of the standard features are electromagnetic door interlocking for the doors, swing type doors with view panels, door open indicator, optional UV lamp on/off, hour meter for measuring the UV light life, fluorescent/white light on/off, blower on/ off, alarm system, digital pressure system and velocity measurement system.

Te m p e r a t u r e range is from 10° C above ambient to 60 °C. Accuracy and uniformity of the incubator is + 0.5 °C and + 1.0 °C respectively. It features 21 CFR PART-11 compliance, log data, event data, audit trail data, e-records and e-signatures, graphical analysis and data acquisition. Optional features are scanner, GSM technology, hooter system and extra tray. Mack Pharmatech Pvt Ltd Nashik – Maharashtra Tel: 02551-230877 Fax: 02551-230877 Email: info@mackpharmatech.com Website: www.mackpharmatech.com

34 Products

Modern Pha rm a | 1-15 August 2013

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

High purity water system High purity water systems for artiﬁcial kidney dialysis unit provides ultra-pure water which meets AAMI Association for the Advancement of Medical Instrumentation & Standards and Recommended Practices (SARPs) requirements. It features PLC based systems with HMI for minimum monitoring and ease of operation, skid mounted modular unit with complete sanitary design, hot water sanitisation RO for better disinfection, minimum space requirement with easy access for maintenance, no chemicals, high rejection of TOC, bacteria and endotoxins, minimum power consumption. Ion Exchange (India) Ltd Mumbai - Maharashtra Tel: 022 - 39890909/ 30472042 Fax: 022 - 24938737 Email: ieil@ionexchange.co.in

O-rings Silicone, viton, neoprene, nitrile and EPDM O-rings are available. Wide range of O-rings from 2.0 mm ID to 600 mm ID from its 5000 single piece moulds are provided. These O-rings are manufactured on a hydraulic press with tightly controlled temperature, pressure and time which ensures accurate dimensions, glossy finish, invisible flash line, properly post-cured and defect free. These O-rings are also manufactured as per the dimensional tolerance specified by the customers and available from NBR, Neoprene, Butyl, EPDM, Hapalon, Viton, Silicone Rubber or in any other rubber as per customers specification. Viton O-Rings upto 3000 mm ID or in any size through step moulding process is also provided. AMI Polymers Pvt Ltd Thane - Maharashtra Tel: 022-28555107/631 Mob: 09223290931 Fax: 022-28555378 Email:amipolymer@vsnl.com Website: www. amipolymer.com

Pilot roll compactor The compactor has multiple roll configurations available like sine curve, interlocking. E a s i l y disassembled product contact parts are manufactured of stainless steel. The machine can

bring into account a wide range of process possibilities. It has a working capacity of 1kg to 15kg/hr with approximately 70 kg net weight. Dimensions of the compactor are 725mmX455mmX555mm and it requires 230 V single phase electricity. Cronimach Machinery Ahmedabad – Gujarat Tel: 079 – 25861418 Email: info@cronimach.com Website: www.cronimach.com

Orbital shaking incubators This orbital s h a k i n g incubator is designed for precise te m p e r a t u re control and simultaneous s h a k i n g applications required in fermentation studies, enzyme reactions, life science, tissue culture and biotechnology research labs. The brushless induction motor with variable frequency drive is suitable for continuous operation. The powerful fan motor is available for forced air circulation to maintain uniform conditions inside the chamber and has hermetically sealed compressor with CFC free refrigerant. Remi Elektrotechnik Ltd Mumbai – Maharashtra Tel: 022-40589888 Mob: 09820627422 Email: sales@remilabworld.com Website: www.remilabworld.com

Multi-purpose trolley Multi-purpose trolley is used for ICU/hospital/ surgery. It comes with multi-purpose aluminum extruded legs, heavy-duty designed castor wheels, MDF monitor top with anti-skid rubber mat, lockable MDF, scratch-proof painted drawer box. Different box or tray are adjusted according to needs due to specially designed proﬁle of tapped strip. Because of aluminium metallic structure, earthing is afﬁrmative and provides safe working for electrical and electronic appliances. Envair Electrodyne Ltd Pune - Maharashtra Tel: 020-30688117 Email: envairelectro@vsnl.net Website: www.envairelectrodyne.com

Pharmaceutical medicines

A wide assortment of pharmaceutical medicines that are known for their effective results are offered. Made in proper hygienic conditions, these medicines are categorised into topical, oro-dental, gynaec & haemostats, intravenous ﬂuids, anti-allergic, cold & cough medicines, antibiotics and quinolones & cephalosporins, antacids, anti-ulcerants & laxatives and appetite stimulants enzymes.

Pump tubing formulation Masterflex Tygon E-Lab (E-3603) pump tubing formulation is an ideal tube formulation for general transfer applications. It provides inexpensive tubing for general laboratory applications. It is very clear for easy flow monitoring, virtually handles all inorganic chemicals, features nonaging & nonoxidising process, low gas permeability and high dielectric constant. Application areas are general laboratory, food & beverage, biopharmaceutical, analytical instruments. It is non-DEHP, phthalate free. It features high chemical resistance and has the ability to bend to sharp radius curves and easily work with fittings. It is FDA compliant (21 CFR 175.300) and it meets USP Class VI and NSF 51 requirements Cole-Parmer India Mumbai - Maharashtra Tel: 022-67162253, 67162222 Fax: 022-67162211 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Schwitz Biotech Ahmedabad – Gujarat Tel: 079-27493057 Mob: 09825374233 Email: schwitz_rkb@rediffmail.com Website: www.schwitzbiotech.com

Glass preﬁllable syringe Prefillable syringes in sterile tub packs range from 0.5 ml to 5.0 ml with a variety of options and customisations. They feature 0.5 ml with luercone / luer lock or staked needle, 1.0 ml long with luercone / luer lock or staked needle, 1.0 ml std, 1.25 ml with luercone /luer lock or staked needle, 2.25 ml with luercone / luer lock or staked needle ½” only and 3.5 ml & 5.0 ml with luercone / luer lock. Some of the options available are 0.5 ml & 1.0 ml long offered in 100 & 160 nest pack, bulk pack and nested rubber plungers, flexible and rigid needle shields (L-1/2”/5/8”/1”).

The syringes are available in sterile and non-sterile form. They comply with international standards. Schott Kaisha Private Ltd Daman - India Tel: (260) 2221192, 2220378, 2221047 Mob: 09978444241 Email: anil.narvekar@schott-kaisha.com Website: www.schott-kaisha.com

Blister thermopacking machine

Automatic thermoformer is designed to produce blister in PVC+aluminum, aluminum, polypropylene, PET and PVC+Aclar. The machine is divided into five sections, defined with particular attention to material and product. Reel compartment hold forming material and splicing table, preheating and forming section, galenic section which encloses the filling station and where product runs on the open web. It can perform sealing, perforating, coding, and punching section. Drive housing and operating mechanisms and electric cabinet is placed on the back of machine frame. The thermoformer works horizontally with forming, coding and cutting in intermittent motion, product feeding and sealing in continuous motion. GMP norms have been followed in the making and the machine is delivered with the Œ mark. Marchesini Group India Pvt Ltd Mumbai - Maharashtra Tel: 022-67082755/64 Fax: 022-67082761 Email: indiaphilippe@marchesini.in Website: www.marchesini.com

BOD incubator The temperature range of the machine is from 10° C to 60 °C with + 0.2 °C accuracy and + 1.0 °C uniformity. It features 21 CFR PART-11 compliance, log data, event data, audit trail data, e-records and e-signatures, graphical analysis and data acquisition. Other optional features such as scanner, GSM technology, extra tray, hooter systems are also available. Mack Pharmatech Pvt Ltd Nashik - Maharashtra Tel: 2551-230877 Fax: 2551-230877 Email: info@mackpharmatech.com Website: www.mackpharmatech.com

Products Steam steriliser Steam steriliser is available in two basic models - gravity displacement system and v a c u u m sterilisers. Gravity displacement systems is suitable only for sterilisation of liquids [in open containers], vacuum sterilisers can sterilise liquids and variety of other materials / components. Customised chamber size ensures flexible loads and load patterns. It features cabinet enclosure for GMP installation, contamination seal to prevent crossflow of air between the clean and unclean area, loading / unloading carts & trolleys for easy and convenient operation, mechanical vacuum pump for pre-pulsing [for air removal], post sterilisation vacuum drying, sterile air filter for vacuum break, in-built test programs for vacuum leak test, pressure leak test and bowie-dick test for higher process assurance, automatic FO calculator with facility for control in case of heat labile materials. It is 0.2 bacteria retentive. Machinfabrik Navi Mumbai - Maharashtra Tel: 022-67368200 Email: abk@machinfabrik.com Website: www.machinfabrik.com

Stability chamber Stability chamber is designed as per international standards to meet requirement of all registration authorities. This equipment offers superior temperature accuracy, humidity accuracy, minimum heat loss, better air flow for maximum uniformity of temperature and humidity. Stability testing is an integral part of formulation development. It helps to generate information, which permits wellconsidered proposals to be made for the shelf life of drug substances products and recommended storage condition. Stability data is required to be submitted as part of the dossier submitted to the regulatory agencies for licensing approval. Sarbi Mumbai – Maharashtra Tel: 022-26049538 Email: sarbi1@vsnl.com Website: www.sarbi.com

GSM alarm system G S M / G P R S SMS alarm system is known as EnviroGSM system. This system is a useful tool to remotely monitor critical systems like industrial automation, remote security and environmental monitoring. EnviroGSM has up to 8 input and 8 potential free alarm outputs, which can be connected to buzzer, CCTV, ﬂood lights and willkie-talkie. It ensures the adoption of advanced end to end monitoring system and is used to monitor

M odern Pha rm a | 1-15 August 2013

critical process control parameter like temperature, pressure, humidity and will generate SMS alerts if parameter crosses predeﬁned levels and security team can then achieve central monitoring by wiring the audio alarm circuits to the security never center. By communicating in a low voltage condition at a particular zone, EnviroGSM can send SMS alert to mobile phones anywhere in the world, including one to security control room. Enviro Technologies Thane - Maharashtra Tel: 022 - 64646500 Email: ankit.s@enviroworld.in Website: www.enviroworld.in

Octagonal blender Octagonal blender features discharge output via. butterfly valve, safety guards provided with limit switch interlocked to motor to ensure safe operation, bump- less rotation. All contact parts are made of SS 316 as per GMP standard. It has zero

retention design. Internal finish conforms 220 grits to 320 grits, outside mat finish180 grits. Charging drum arrangement with mechanical / hydraulic trolley is provided. Other features include safe earthing systems, optional accessories/ attachments, flame proof construction, PLC with MMI and VFD. Applications include blending of dried granules for tablets and blending of dry powders for capsules. Documentation like DQ, IQ, OQ and FAT is provided with the machine.

V blender

Jay Pharma Equipments Mumbai - Maharashtra Tel: 022 - 32155790 Email: jkpharm1@gmail.com Website: www.jaypharmaequipments.com

Cronimach Machinery Ahmedabad - Gujarat Tel: 079 – 25861418 Email: info@cronimach.com Website: www.cronimach.com

V blender is an ideal mixer for cream, ointment and paste. All parts are made of stainless steel and are highly polished. The blender can produce a homogeneous mixture. Technical specifications are 43 Kg weight, 68 kg gross weight, 660mm x 482mm x 630mm dimension and electrical specifications 0.25HP, AC, 230V, 50Hz, 3Ph.

36 Products Silicone transparent braided hose

AMI Polymers Pvt Ltd Thane - Maharashtra Tel: 022-28555107/631 Mob: 09223290931 Fax: 022-28555378 Email:amipolymer@vsnl.com Website: www. amipolymer.com

Track and trace system Silicone transparent braided hose conforms to USP Class VI requirement & FDA 21 CFR 177.2600. This braided hose is made from 100% pure silicone rubber by using fully automatic state-ofthe- art machineries and technologies. The medical grade braided hose is manufactured under stringent quality control. The braided hose is temperature resistant from -80°C to 250°C (-110°F to 480°F), non-reactive to body tissue and fluid and has non-adherence to tissue. It is unaffected by most water soluble materials and is sterilisable by steam, dry heat, ethylene oxide (ET) and gamma radiation. It resists oxidation, ozone and radiation and has an indefinite shelf life. Available size is from 6 mm ID to 60 mm ID.

Track and trace system is powered to create a complete identification and data verification solution for labels on pharmaceutical medical device packaging and healthcare serialisation. It reads 2-D and 1-D barcodes: Data Matrix, GS1-128, GS1 dataBar, securPharm and Pharmacode. It can verify correct ID code contents, including compliance with the GS1 Healthcare data standard, supports FDA 21 CFR Part 11 validation compliance with change tracking, double blind and secondary

Modern Pha rm a | 1-15 August 2013

authentication, provides data matrix mark quality assessment during production to detect changes in print quality, verify the accuracy of printed text & skew, detect label misalignment & skew and supports bundle aggregation. Cognex Sensors India Pvt Ltd Pune - Maharashtra Tel: 020- 40147840 Fax: 020-66280011 Email: sisd.support.asia@cognex.com Website: www.cognex.com

Thermo Scientiﬁc Molecular Bio Products Molecular Bio Products are made from plastics injection moulding and their core competency and focus is to provide value added solutions to the liquid handling needs of the life science researcher in academia, biotech and pharmaceutical companies around

the globe. Bio products like pipette tips, gel loading tips, reach tips, solvent safe tips, wide bore tips and racks are produced by applying statistical process control, statistical quality control, and other cutting edge technology. The products also features patented technology of ART-Aerosol resistant tips which are the only barrier tips available in the world which function on unique self sealing barrier preventing pipette contamination and carry over contamination caused by aerosols and liquids. Thermo Fisher Scientiﬁc India Pvt Ltd Powai, Mumbai Tel: +91 22 6716 2200, +91 22 6716 2259 Fax: +91 22 6716 2244 Toll Free No: 1800 22 8374 Website: www.thermoﬁsher.com , www.thermo.com

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

Linear bottle washing machines

The linear bottle washing machines facilitates inline washing operation and are built on rigid structure and are enclosed with elegant matt ﬁnished SS body cover. The cleaning is supported by tow inbuilt water tanks and pumping system. The output ranges from 3000 to 4200 bottles, and direction of movement is left to right. National Pharma Machinery Ahmedabad - Gujarat Tel: 079-30903433, 30933433 Email: sales@nationalinda.co.in Website: www. nationalpharmamachinery.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

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M odern Pha rm a | 1-15 August 2013

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Modern Pha rm a | 1-15 August 2013

Looking for a specific product? Searching and sourcing products was never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Product

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Product

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Product

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Acoustic enclosure ......................................... 23,33

Dehumidiﬁer.........................................................................36

Label........................................................................................37

Pump .................................................................................23,33

Air circuit breaker ...............................................................BIC

Dispensing and sampling isolator.................................. 33

Lake pigment ......................................................................... 6

Pump tubing formulation ................................................34

Air sterilisation .....................................................................BC

Dispersion ............................................................................... 6

Laminar air ﬂow unit.........................................................FIC

Pure water and steam process ......................................... 8

Analytical instrument ............................................... 3,21,27

Dissolution testing.................................................................7

Laminar airﬂow cabinet.................................................... 33

Rapid endotoxin detection system ................................37

Bacteriological incubator ...................................33

Drive/invertor ......................................................................BIC

Linear bottle washing machine ......................................36

Refrigrated compressed air dryer .................................... 12

Barcode patient ID band ...................................................37

Dry van pump..................................................................23,33

Loniser..................................................................................... 12

Reverse laminar air ﬂow ..................................................FIC

Bearing................................................................................... 35

Dynamic pass box..............................................................FIC

LVS .........................................................................................BIC

Roots blower ...................................................................23,33

Blister thermopacking machine .....................................34

Electric actuator and gripper ..............................12

Metal doorset.......................................................FIC

Rotary dry............................................................................... 13

Blow-ﬁll seal machine......................................................... 9

Empower ................................................................................27

Modular clean room ..........................................................FIC

Sanitary tubes ﬁtting ..........................................36

BOD incubator .....................................................................34

Exhibiiton - Plastivision 2013 ...........................................37

Molecular bio product .......................................................36

Servo......................................................................................BIC

Cable carrier...........................................................35

Fire resistant door ...............................................FIC

MRFRS of thermoplastic valves and piping system from

Silence ﬂow package .......................................................... 13

Cable connector .................................................................. 35

Glass preﬁllable syringe ......................................34

polypropylene .......................................................................14

Silicone transparent braided hose.................................36

Calibration .............................................................................10

GSM alarm system.............................................................. 35

Multipostion stirrer ..............................................................15

Stability chamber ............................................................... 35

Centrifugal fan...................................................................... 13

Guided compact pneumatic cylinder............................. 12

Multipurpose trolley...........................................................34

Steam steriliser.................................................................... 35

Chain....................................................................................... 35

Heat transfer equipment.....................................13

Natural food colour................................................6

Stirring hot plate ..................................................................15

CIP/SIP system and effluent treatment plant ............. 8

High pressure blower .......................................................... 13

Octagonal blender ...............................................35

Tefzel HHS isotactic PP material ...................... 14

Clean room door.................................................................FIC

High purity water system..................................................34

Orbital shaking incubator.................................................34

Track and trace system .....................................................36

Cleanroom equipment and accessories ........................ 31

High purity water treatment systems for injectible.... 8

O-ring .....................................................................................34

Truck blower .......................................................................... 13

Colloid mill ............................................................................ 33

HMI .........................................................................................BIC

Packaging machine and packaging solution 28

Turnkey solution for biotech and pharma industry ..BC

Coloumns and chemistries................................................27

HPLC ........................................................................................27

Pharmaceutical medicine ................................................34

UPLC........................................................................ 27

Compact pneumatic cylinder ........................................... 12

Human-machine interface .............................................BIC

Physical testing ......................................................................7

V blender ................................................................35

Connector.............................................................................. 35

HVAC and MEP ....................................................................BC

Pilot roll compactor ...........................................................34

Vacuum booster pump ................................................23,33

Contactor and motor starter ..........................................BIC

Informatics ............................................................ 27

PLC .........................................................................................BIC

Vacuum pump ...........................................................13,23,33

Container sterilisation .......................................................BC

Innovative pumping solutions for pharmaceuticals and

Primary and secondary packaging for injectable drug29

Validation and temperature/RH mapping...................10

Content uniformity testing .................................................7

biotech ....................................................................................19

Printer......................................................................................37

Water soluble synthetic dye ................................6

D&C colour ...............................................................6

Inspection system.................................................................11

Process gas blower .............................................................. 13

Xray inspection system ........................................17

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover Advertiser’s Name & Contact Details

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Airtech Systems (I) Pvt.Ltd.

Advertiser’s Name & Contact Details

Everest Blowers

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Advertiser’s Name & Contact Details

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Nichrome India Ltd

Advertiser’s Name & Contact Details

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Skytech Systems (India) Pvt Ltd

T: +91 - 22 28592275

T: +91-11-45457777

T: +91-20-66011001

T: +91-022-4153 3333

E: sales@airtechsys.in

E: info@everestblowers.com

E: marketing@nichrome.com

E: info@skytechindia.com

W: www.airtechsys.in

W: www.everestblowers.com

W: www.nichrome.com

W: www.skytechindia.com

All India Plastics Mfrs Association

Fabtech Technologies Intl Pvt Ltd

Oorja Technical Services Pvt Ltd

Sotax India Pvt Ltd

T: +91-22-28217324

T: +91-22 61592900

T: +91-731-4207571

T: +91-022-42950191

E: pvi13@plastivision.org

E: sales@fabtecheng.com

E: sales@oorjaenterprises.com

E: sotaxindia@sotax.com

W: www.plastivision.org

W: www.fabtecheng.com

Bry Air (Asia) Pvt Ltd

GMP Technical Solutions Pvt Ltd

FIC

Praj Industries Ltd

Swam Pneumatics Pvt Ltd

T: +91-22 66083790

T: +91-020-2290 5000

T: +91-0120-4696222

E: bryairmarketing@pahwa.com

E: prashant@gmptech.net

E: info@praj.net

E: swamatic@airtelmail.com

W: www.bryair.com

W: www.gmptech.net

W: www.praj.net

W: www.swamatics.com

Great Eastern Impex Pvt Ltd

Reynders Label Printing India Pvt Ltd

Toshvin Analytical Pvt Ltd

T: +91-80 - 25588175

T: +91-011-2347431/32

T: +91 149 3305400

T: +91 22 2301 5096

E: india.customercare@crl.com

E: sales@geipl.com

E: india@reynders.com

E: kiran@toshvin.com

W: www.criver.com

W: www.geipl.com

W: www.reynders.com

W: www.toshvin.com

Cole-Parmer India

Igus India Pvt Ltd

Roha Dychem Pvt Ltd

UNP Polyvalves India Pvt Ltd

T: +91-22-67162222

T: +91-1-80-39127800

T: +91 22 4077 3333

T: +91-265-2649248

E: response@coleparmer.in

E: info@igus.in

E: support.imc@rohagroup.com

E: mktg@polyvalve.com

W: coleparmer.in/3125

W: www.igus.in

W: www.rohagroup.com

W: www.polyvalve.com

Dover India (P) Ltd

Ishida India Pvt Ltd

Salesworth Synergies Pvt Ltd (Rommelag)9

Waters (India) Private Ltd

T: +91- 44-26271020/21/22/30

T: +91-124-3854392

T: +91-80-25274495

T: +91-80-28371900

E: sales.psgindia@psgdover.com

E: sales@ishidaindia.com

E: mail@salesworthsynergies.com

E: waters_india@waters.com

W: www.psgdover.com

W: www.ishidaindia.com

W: www.rommelag.com

W: www.waters.com

Everest Blower Systems

Mitsubishi Electrical India Pvt Ltd

W: www.sotax.com

T: +91-11-23906777

Charles River

BIC

Salesworth Synergies Pvt Ltd (Seidenader)11

West Phmaceutical Packaging India

T: +91-11-45457777

T: +91-020-27102000

T: +91-80-25274495

T: +91-040 -49401111

E: info@everestblowers.com

E: info@mei-india.com

E: mail@salesworthsynergies.com

E: alagu.subramaniam@westpharma.com

W: www.everestblowers.com

W: www.MitsubishiElectric.in

W: www.seidenader.de

W: www.estpharma.com

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