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In Conversation With 13

Special Focus 14

Policies & Regulations 17

Roundtable 19

Dr Ruchi Dass Founder, Healthcursor Consulting Group

EU-India Free Trade Agreement What is at stake for pharmaceuticals?

Indian pharmacy drug stores Need to have a strict regulatory system

Is the race for generics stifling innovation in Indian pharma sector?

Dr Frank Heinricht appointed Chairman of the Board of Management of SCHOTT AG The Supervisory Board of SCHOTT AG unanimously appointed Dr Frank Heinricht to the position of its new Chairman Dr Heinricht of the Board of Management in its meeting on February 27, 2013. Heinricht (50) is currently the Chairman of the Board of Management of Dr Heraeus Holding GmbH. He completed a degree in physics and a doctorate in engineering at the Technical University of Berlin and began his professional career at TEMIC Semiconductors. After holding positions as General Manager and Chairman of the Integrated Circuits Division, he was appointed Chief Executive Officer of TEMIC Semiconductor Group, in 1998. In 2003, Dr Heinricht joined Heraeus Holding GmbH as Member of the Board of Management. He was appointed Chairman of the Board and Labor Director in 2008. Dr Frank Heinricht will take office on June 1, 2013.

Venus signs exclusive marketing rights for Potentox with South Africa’s Adcock Venus Remedies Ltd, the research-based global pharmaceutical company has accord exclusive marketing rights for its novel antibiotic product, Potentox, to South Africa’s pharmaceutical giant Adcock in a deal the company announced. “We are pleased to join hands with Adcock and are confident that the deal shall take our research product to its meaningful stage in South Africa. Adcock will have exclusive marketing rights of the product in South Africa over the period of 15 year. The product will remain under patent protection till 2025 in African territory and is expected to be launched by mid of 2015 after getting due regulatory approvals.” said Pawan Chaudhary, CMD, Venus Remedies Ltd.

Dr. Reddy’s announces the launch of zoledronic acid injection Dr. Reddy’s Laboratories has launched zoledronic acid injection (4 mg/5 mL), a bioequivalent generic version of Zometa® (zoledronic acid) 4 mg/5 mL injection in the US market on March 4, 2013, following the approval by the USFDA. Dr. Reddy’s zoledronic acid injection 4 mg/5 mL is available in a single use vial of concentrate.

Agility India inaugurates its first temperature controlled facility for pharma near Nhava Sheva With the Indian pharma sector bustling loggers, and consolidation processes with activity and business growing at 14 are set to be undertaken under the per cent per year, the need for advanced supervision of B Pharma graduates. logistics services has prompted Agility The consolidation centre will witness India to set up a temperature-controlled a monthly maintenance and internal warehouse for its pharmaceutical audit. The company will provide customers near Nhava Sheva (near end-to-end services; starting from Mumbai). Agility, manages entire collection of temperature controlled logistics systems that include warehousing, distribution, sorting and kitting. The consolidation centre was inaugurated by Chris Price, CEO - Asia Pacific region. This 3,000 sq feet, dedicated temperature controlled warehouse will p r o v i d e Price inaugurating the facility customers in West India with optimal storage and shipments in reefer vehicles to delivery of the same to respective customers. handling facilities. This custom bonded facility located With Agility’s cost effective sea freight at CWC Logistics Park CFS, Hind solutions for the pharma sector, Agility Terminal Facility, controlled at 18 oC, expects to see a healthy growth in the has all contingency measures in place requirement of such services. Commenting on the new in case of a power failure. Further, the facility provides continuous development, Price, said, “We have temperature tracking systems, daily data our roots in emerging markets and we

make significant investments in such markets. We are looking to serve to our customer’s specific needs and provide value-added customer-driven solutions. India is seeing a lot of potential. With the current surge in generic drug market, we expect to see a lot more demand for such inclusive services as shipment sizes are going to get bigger. Against this backdrop, pharma supply chain consolidations will give pharma companies more value.” With its latest endeavour, Agility is plugging gaps such as the transport problems associated with small shipments, troubles that arise due to extreme temperature and humidity conditions, unsuitable storage facilities and high costs associated with pharma freight operations. The next step for Agility is weekly departures to Rotterdam and Antwerp. Currently, Agility serves pharma biggies such as Dr Reddy’s, Mylan, Hetero Drugs, Aurobindo etc. With reliable port-to-port transit times, good distribution practices and comprehensive knowledge about import and export regulations, Agility is well set to support its growing pharma customer base. Pallavi Mukhopadhyay

Cambridge Consultants workshop reveals Indian pharma growth outpaces rivals Ranking among the top five globally by production volume, the Indian pharmaceutical market today accounts for over 10 per cent of global drug production. It continues to be one of India’s biggest employers – with more than 340,000 Indian employees dedicated to an industry that is worth in excess of $ 22 billion. But senior delegates at the Cambridge Consultants Mumbai pharma workshop  said Indian pharmaceutical companies must embrace innovation and adopt technology if they are to stay competitive at both a domestic and global level. The Cambridge Consultants workshop, attended by a cross–section of senior personnel from a variety of functions within leading Indian and MNCs, explored the question whether India would become one of the world’s leading pharmaceutical countries by 2030? Recent reports suggest India’s domestic pharmaceutical sector will grow to $ 55 billion by 2020.  As a significant exporter of high-quality

generic drugs, India is expected to see the value of its drug exports double to $ 25 billion by the end of 2014, according to the country’s Minister of Health. Delegate feedback revealed that the Indian pharmaceutical industry still has significant growth opportunities, and major local companies could have the potential to compete with multinational pharmaceutical companies. Among them, the greatest impact in world markets will come from those Indian pharmaceutical companies which adopt technology innovations to differentiate their products and make them more competitive both domestically and globally. This trend for differentiation is particularly important as Indian pharmaceutical companies have fewer new generic opportunities. This is because the number of New Chemical Entity (NCE) filings to the US FDA has declined over recent years and the number of innovator drug patents

reaching their expiry date has peaked. Similarly, at a global level there are more generic pharmaceutical developers from other emerging nations, including China,which will offer low-cost competition for India, as well as the ongoing global threat of counterfeit drugs. Andrew Barrett, Director, Medical Technology in India, Cambridge Consultants, said, “In order to drive faster growth, and capitalise on their existing success, Indian pharmaceutical companies must now aim to create true added-value offerings with ‘super-generics’, which can deliver additional benefit to patients. Innovation and technology are key, and the required investments can be recouped because medical products have long lifecycles. Technology has a great role in drug delivery to extend these lifecycles, add value and, importantly, allow product differentiation in a crowded market space.”



Post-Budget Analysis Did the pharmaceutical indutry receive the desired boost?

In Conversation With


Dr Ruchi Dass Founder, Healthcursor Consulting Group





Special Focus Anti-counterfeiting EU-India Free Trade Agreement What is at stake for pharmaceuticals?


Interface Didier Lacroix Senior Vice President, International Sales & Marketing, Cognex


Roundtable Should we push for affordable anti-counterfeiting solutions to support the strict regulatory norms in India?


Insight & Outlook Policies & Regulations Indian pharmacy drug stores: Need to have a strict regulatory system



Interface Kiran A Badgujar Managing Director, Mack Pharmatech Pvt Ltd


EDITORIAL TEAM Parita Dholakia, Pallavi Mukhopadhyay, Rishab Kothari, Hardik Ashar (Bengaluru), Nikunj Sharma (Delhi) ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan CHIEF PHOTOGRAPHER Mexy Xavier

Roundtable Is the race for generics stifling innovation in Indian pharma sector?



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Budget 2013-14: Practical, plausible or potent? t first glance, the Union Budget 2013-14 seems to have taken a fairly cautious step with a clear focus on getting a good grip on fiscal fitness. To begin with, the Budget has emphasised that infrastructure development and Micro, Small and Medium Enterprises (MSMEs) are the key to fuel the growth of the Indian economy. Other noteworthy initiatives include measures to strengthen the investment climate in manufacturing and infrastructure, MSME growth and capital market development. These should benefit the pharmaceutical industry directly and indirectly. Although full-fledged implementation of the Goods and Services Tax (GST) is still months away, the Finance Minister’s proposal for payment of ` 9,000 crore as the first installment of the balance of Central Sales Tax (CST) compensation is a step in the right direction. Among other highlights, the Budget recommendation to extend MSME benefits for a period of three years after moving to a higher category is well timed and meets the need of the hour. It should motivate home-grown emerging enterprises to take the next big leap in their growth trajectory. In addition, the exemption of 15 per cent in investments of more than ` 100 crore to set up plant and machinery should galvanise industrial activity in the country. Moreover, the commitment to increase availability of low-cost funds to the infrastructure sector augurs well for higher investments.


Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Last but not the least is the spotlight on the National Skill Development Programme as well as the additional ` 200-crore outlay to fund ‘technology for common man’, which is essential to broadbase the country’s growth considering the abundance of educated youth and their aspirations. Although this Budget lacks the fireworks of its previous editions, its proposals can be considered as the best possible step by the government in the current complex geo-political climate. At a time when the whole world is looking at emerging nations such as India to accelerate the global growth engine, the government has most likely missed an opportunity to give a greater thrust to various economic policies. For more insights on the Budget and its impact on the pharmaceutical sector, turn to the experts’ views in Post-Budget Analysis. Summing up, the actual outcome of the Budget will be evident only from its effective implementation. While it is imperative for the government to ensure that policy announcements stay on track, the industry needs to leverage the advantages offered in this Budget to take the India success story a notch higher.

Manas R Bastia

Guest Editorial

Delivering better health outcomes ould you ever decide to make a medicine that strengthened a disease? I do not think counterfeiters ever considered that when they decided to produce fake tuberculosis drugs. Roger Bate chronicles the resulting devastation in his recent New York Times op-ed ‘Feeding a Disease with Fake Drugs.’ He writes, “These substandard drugs are almost certainly making the disease more resistant to drugs, posing a grave health threat to communities around the world.” Counterfeiters have ripped off too many: the doctors who expect their prescribed treatment to work; the pharmacists who believes they are selling quality products; the manufacturers who have pursued the R&D costs of developing life-saving medicine; and worst of all, the patients whose lives have been cut short due to some bad pills that they received. While there is a lot to be done in this field as not many businesses have done something strongly in this direction to fight against substandard drugs. Patients and common consumers have the fundamental right to exercise their right to know if they are safe from the medicines they take especially


in emerging economies where the scenario of counterfeiting is even worse. PharmaSecure is playing an important part in addressing this problem. Our systems have protected the distribution of 80 million authentic tuberculosis treatments by  printing each medicine package with a  unique eight- or nine-digit code that patients can verify by SMS, phone call, web or mobile app. Moreover, we are not just protecting tuberculosis patients, as our codes have been present on a half billion medicines. We are also working hard to translate a patient’s verification of medicine activation of health engagement. After patients verify their medicine (or anytime they need), they are able to talk to a health advisor on the phone and sign up for free reminders to take their medicine, further reducing the risks of adherence and result in better health outcomes.We are also following up with patients after they take their treatment to understand where and when patients drop out of their treatment. Millions of lives and an estimated $ 500 billion are lost annually due to prescription non-adherence across

a variety of diseases. We applaud the work of Roger Bate and his colleagues in bringing attention to the growing problem of drug resistant tuberculosis, and we know the solutions are here. The question is, where is the industry? Embrace the solutions — they are a winwin for patients and manufacturers, whose boldness will be rewarded not monetarily, but humanitarianly as well. Nathan Sigworth Co-Founder & CEO Pharmasecure



News, Views & Analysis Telezon ships first SoloFlow® batch to Serum Institute of India for use in vaccine kits Victoria-based medical device company Telezon Ltd announced the dispatch of first commercial shipment of 1,00,000 units of SoloFlow® to Serum Institute of India (SII), making up part of the 5,00,000 commercial order. Telezon’s SoloFlow needles are being used in SII’s vaccination kits for the world market. Following a shipment of 28,600 needles, SII has approved the company as an official vendor of the SoloFlow needle and ordered a further half a million units for their vaccination kits. The shipment is the first of three, which will be delivered over the next few months. Pleased with this shipment, Dr Michelle Carr, Director and Company Secretary, Telezon Ltd, said, “We have built a healthy working relationship with SII and we look forward to strengthen this relation. I am pleased that the company

is consistently achieving its commercial outcomes in global markets creating values for its unique suite of medical device solutions.” Following


Victorian Life Sciences Trade Mission to India in February this year, the company is in discussions with several global organisations about potential supply of their products. Hardik Ashar

US FDA approves highly cohesive anatomically shaped silicone-filled breast implants US FDA has approved the marketing of Natrelle® 410 highly cohesive anatomically shaped silicone-filled breast implants for use in breast reconstruction, augmentation and revision surgery. “The FDA approval of Natrelle® 410 shaped gel implants provides an important new alternative to traditional round implants for women considering breast augmentation, reconstruction or revision surgery,” said David E I Pyott, Chairman of the Board, President and Chief Executive Officer, Allergan. “The Natrelle® 410 is the most selected shaped gel implant in markets where the product is already available, such as Europe and Canada. We are pleased that the FDA has recognised the benefits and safety of the Natrelle®

410, and has now made the product available as an additional option for women in the US.” This implant is designed to mimic the slope of the breast and is filled with a highly cohesive silicone gel, which is intended to enable

the implant to hold its shape over time while remaining soft to the touch. The approval is based on an extensive review of various studies and data, including pre-clinical device testing and clinical data from Allergan’s 10-year prospective, multi-centre pivotal study, involving nearly 1,000 women who have undergone breast reconstruction, augmentation or revision surgery. “For many patients, round silicone

and saline breast implants are good options. For others, they may not provide the aesthetic outcome they desire,” said Scott L Spear, Chairman, Department of Plastic Surgery, Georgetown University School of Medicine. “Also, patients may have minimal breast tissue remaining after the removal of a tumour or have lost breast volume over the years, so the option of a shaped breast implant designed with an anatomical shape that lasts over time is an important one as it may help these patients obtain the aesthetic look they are seeking.” Allergan requires surgeons to complete a certification program, which includes instruction on surgical techniques and patient selection, before they are able to offer the Natrelle® 410 shaped gel implant option to their patients.

UBM introduces UBM DeusM and UBM Live launched to link various stakeholders in pharmaceutical field at one platform. will establish a global network to help professionals grapple with the sweeping changes affecting the pharmaceutical industry today. It will leverage the strength of UBM Live’s CPhI global exhibition and conferences brand and DeusM’s expertise in developing vital, engaged online communities. It will also draw from the example of UBM Medica’s successful online oncology nurse community, Agnes Shanley, Editor, pharmaEvolution. com, said, “For pharmaceutical professionals today there is an enormous pressure to innovate and manufacture more efficiently, with fewer resources, all while improving product safety and quality. There is a real need for better risk management and more scientific approaches to quality assurance and control.” On PharmaEvolution, leaders in the industry’s evolution to more innovative R&D and manufacturing share best-practices, selfassessment tools, technical articles, webcasts, chat and non-traditional formats designed to help professionals improve results. Rather than aggregated content written by journalists, will feature original content, written mainly by industry professionals.  It will create a safe and secure online environment where peers can share best non-proprietary practices, troubleshoot problems, and openly discuss challenges and issues without intrusive marketing messages, unethical use of personal information or unfocussed discussion. Content on the site focusses on those areas most critical to the industry and the patients and physicians it serves:  R&D, manufacturing and quality, formulation, APIs and excipients, drug delivery, packaging and anti-counterfeiting, regulatory compliance, contract services and supply chain management. PharmaEvolution is published by UBM Live, UBM DeusM, and founding sponsor Capsugel, along with Aptalis, Harlan, and B-Braun. Capsugel is an established pharma industry leader, specialising in dosage form development for more than 100 years.


News, Views & Analysis

Edison Pharma begins phase 2 Cobalamin C deficiency syndrome clinical trial for EPI-743 Edison Pharmaceuticals began phase 2 Cobalamin C deficiency syndrome clinical trial for EPI-743 in collaboration with Bambino Gesù Children’s Hospital. The placebo-controlled trial for one year preceded by a six-month study in phase for all candidates to establish a defined clinical and metabolic baseline. The primary endpoint is improvement in visual function with secondary outcome measurements assessing neurologic and neuromuscular function, glutathione biomarkers, quality of life, as well as safety parameters. The rationale underlying this investigation is centered on understanding whether EPI-743 – a therapeutic targeting primary defects in

electron transport– might hold therapeutic benefit in disorders of intermediary metabolism that also result in redox disturbances. “Cobalamin C deficiency represents an inherited disorder that induces perturbations in the metabolism of glutathione. Given the central role of glutathione in cellular redox balance and antioxidant defense systems, we are eager to explore whether a therapeutic that increases glutathione such as EPI-743 will provide clinical benefit,” stated Professor Carlo DionisiVici, Division of Metabolism, Bambino Gesù Children’s Hospital– the trial’s principal investigator. Cobalamin C (Cbl-C) defect belongs to the family of diseases known as methylmalonic acidurias and is

the most common inborn error of vitamin B12 metabolism. Cbl-C defect is a syndrome that results in multiorgan system disease most significantly impacting the central nervous system. While the clinical presentation can be heterogeneous, the onset of symptoms typically arises within the first year of life and includes seizures, hypotonia, hydrocephalus, developmental delay, and failure to thrive. Visual impairment results from retinal atrophy and oculomotor defects. Cardiovascular disease, hemolytic uremic syndrome, and gastrointestinal involvement may also occur. A smaller subset of patients may present later in childhood or early adulthood and typically have a milder phenotype with neurological and vascular manifestations.

Sigma-Aldrich opens new GSS centre in Bengaluru Sigma-Aldrich Corporation, a leading life science and business analytics. From transactional to highly and high technology company, announced the strategic responsibilities, our GSS India employees expansion of its Global Shared Services (GSS) centre are helping to support our global business growth in India, which supports the company globally and accelerate operational excellence” she said. by offering value-added capabilities to “APAC remains a key area drive business growth and accelerate of focus for our Company operational excellence. “India remains not only from a growth a major focus for Sigma-Aldrich,” said perspective but also in terms Karen Miller, Senior Vice President of infrastructure support for Corporate Development and Corporate our global franchise,” said Communications, Sigma-Aldrich Jason Apter, Vice President Corporation. “With GSS, we will leverage and Managing Director, our capabilities, talent and infrastructure Sigma Aldrich Team Asia Pacific. Building a in India to better serve our global strong focus on customers, customer base” Miller added. “Our highly educated he said, “We are now taking new products to new colleagues in GSS are supporting many of our global as well as existing customers.” Hardik Ashar functions, including strategic marketing, sales support

In Brief Elder Pharma wants JV with Kose Corp to be on track by June Elder Pharmaceuticals is looking at getting its JV project with Japan’s Kose Corporation on track in the next three months by making use of its in existing plant in Himachal Pradesh. Aiming to tap the changing world of women’s fashion and taste in cosmetics, Elder Pharma has forged the joint venture with Kose Corporation to manufacture and sell cosmetics in India through a JV company that is provisionally named  Kose Elder (India) Pvt Ltd.  “We are not setting up a new plant. We already have an existing plant in Paonta Sahib in Himachal Pradesh, which is making pharmaceutical products. We are looking at getting this project on stream in the next three months,” Alok Saxena, Joint Managing Director, Elder Pharmaceuticals, stated.

Dr. Reddy’s holds 98.6 per cent of shares in the Netherlands-based OctoPlus Dr. Reddy’s Laboratories (DRL), an integrated global pharmaceutical company, announced that the company holds 98.6 per cent of the shares in the Netherlands-based speciality pharmaceutical company, OctoPlus, after the post closing acceptance period. The company said, 5.2 per cent of the shares have been tendered during the post closing acceptance period, which together with shares acquired by the offeror during the post closing acceptance period and the offer period represent in total 98.6 per cent of the shares.

HLL introduces non-steroid oral contraceptive pill In a fitting tribute to the Indian womanhood on the International Women’s Day, mini-Ratna public sector undertaking HLL Lifecare Ltd launched the popular Oral Contraceptive Pill (OCP) across the leading e-commerce portals so that women can have easier access to it. “It marks the freedom of women. They can make the rightful choice to safe and reversible contraception in the easiest way, from the comfort of their homes or workplaces,” said Dr M Ayyappan, Chairman and Managing Director, HLL. By going online, Saheli will now be available in leading shopping portals such as Indiatimes, Homeshop18, Healthshoppe, Indiaplaza, Ebay, Healthkart, Healthgenie and Cilory, to name a few, he added. The pill, originally developed by Central Drugs Research Institute (CDRI) as India’s first indigenous molecule (Centchroman), was commercialised by HLL in 1991. It is the only non–steroidal pill with no side-effects as ormeloxifene is the active ingredient.




News, Views & Analysis

Evonik India organises conference on latest developments in the pharma sector Modern medicines are expected to meet an increasingly broad spectrum of requirements. At the same time, customised solutions are needed to treat a wide range of diseases. In a rapidly progressing India, with growing middle class, fast globalising pharma sector, and competition on the rise, companies are expected to deliver the best. In order to share knowledge about the latest happenings in the research and development sector, Evonik Degussa India Pvt Ltd took the initiative to host a seminar for the pharma and healthcare industry on March 5-6, at Hyatt Regency,

Andheri East, Mumbai. Titled ‘Innovative Technologies in Healthcare 2013’, the seminar covered relevant topics in pharma and chemical industries, from nanotechnology to efficient active ingredients. It included sessions by a number of subject matter experts with illustrious careers, including Dr Panos Konstantinides, present Vice Chair of the AAPS Formulation Design and Development (FDD) Section and affiliate professor at Roosevelt University, Illinois and Dr R B N Prasad from Indian Institute of Chemical

Technology (IICT), Hyderabad. The speakers tackled subjects

The conference underway

ranging from nanoparticle filtration, nutraceuticals, spray drying and melt extrusion to PEEK implants and advance medical devices.

The seminar was the first of its kind hosted by Evonik India. Aimed at providing a platform for advance technologies in healthcare, pharma and medical devices industry, the seminar saw strong participation of around 90 participants over two days, from established pharma and healthcare companies including Dr. Reddy’s, Ranbaxy, Cipla, Alembic, Jubilant, Steer, GESCO and Glenmark among others.

Agilent Technologies and Applied Proteomics Inc inks agreement Agilent Technologies Inc inked agreement with Applied Proteomics Inc (API) for collaborating on highly multiplexed protein assays and workflow solutions to monitor multiple reactions using mass spectrometry. API would incorporate Agilent 6490 Triple Quadrupole

MS, RapidFire 360 MS system, 1290 Infinity LC, and bravo liquid-handling techniques. Speaking on the development, John E Blume, Ph D, CSO, Applied Proteomics said - “The ability to quickly and accurately measure, monitor and analyse a large number of protein

biomarkers in a single test has important applications for understanding human diseases and developing new clinical diagnostics. Agilent’s innovation in mass spectrometry is an important part of this collaboration as we work together to expand the capabilities of multiplex protein assays.”

Speaking on the occasion, Frank Lelek, President, India Region, Evonik, said, “We had about 90 participants and there seems to be an appreciation for the topics discussed. The success of this seminar has prompted us to understand the key needs of the Indian healthcare industry. We hosted this event as healthcare is one of our biggest focus areas and has a lot of future potential. We hope to continue this initiative and host more in-depth seminars about innovative technologies in similar platforms.” Pallavi Mukhopadhyay

Mylan to buy injectable drug unit of Strides Arcolab for $1.6 billion in cash Strides Arcolab Ltd announced that it has entered into a definitive agreement for the sale of its specialties subsidiary, Agila Specialties Pvt Ltd, a developer, manufacturer and marketer of high-quality generic injectable products to US based generic giant Mylan Inc for $ 1.6 billion in cash. The acquisition of Agila will strengthen Mylan’s global injectables platform providing Mylan entry into new high-growth geographic markets. Commenting on the transaction, Arun Kumar, Executive Vice Chairman and Group CEO, Strides Arcolab, said, “The sale of Agila demonstrates our commitment to maximising value to our shareholders. Our investments in the business, together with the operational excellence of our employees, have led to the creation a global, high-quality specialty injectables business with an industry-leading pipeline and bestin-class infrastructure.” Agila, headquartered in Bengaluru, India, will bring Mylan a broad product portfolio of more than 300 filings approved globally and marketed through a network covering 70 countries, including 61 Abbreviated New Drug Applications (ANDAs) approved by the US FDA. Agila has a global pipeline of approximately 350 filings pending approval, including 122 ANDAs pending FDA approval. Agila’s R&D and regulatory track record are reflected in its industry-leading number of approvals and fast approval timeframes. The company currently produces products across nine high-quality manufacturing facilities in India, Brazil and Poland, eight of which have been approved by the FDA. Agila’s manufacturing capabilities include vials, pre-filled syringes, ampoules, lyophilisation, cytotoxics and antibiotics. Agila’s manufacturing base represents one of the largest steriles capacity in India and one of the largest lyophilisation capacities in the world. In addition to its established presence in developed markets, Agila has a strong position in high-growth emerging markets, including Brazil. Agila’s capabilities complement Mylan’s existing injectables platform of more than 500 products marketed globally, including 55 ANDAs, and its high quality sterile manufacturing facilities in Ireland and India. Rajiv Malik, President, Mylan, said, “By combining Agila’s strong injectables capabilities with Mylan’s powerful global engine, we will catapult our injectables business to a new level. “We remain committed to maintaining our investmentgrade credit profile,” added John Sheehan, CFO, Mylan.


News, Views & Analysis

Venus Remedies’ Meropenem receives market authorisation in Mexico Venus Remedies Ltd, a researchbased global pharmaceutical company has received grant of market authorisation from COFEPRIS, the Drug Regulatory Authority of Mexico, for its Meropenem 500 mg and 1000 mg in Mexico. This grant from COFEPRIS (La Comisión Federal para la Protección contra Riesgos Sanitarios), the Latin America’s most stringent regulatory authority, is further endorsement to Venus Remedies’ R&D capabilities and its expertise in developing world class products. Market authorization for Meropenem will enable Venus Remedies to launch its first product in Mexico and will strengthen its position in Latin America where Venus is currently exporting to various countries of LAC such as Columbia, Peru, Guatemala, Dominican Republic, Jamaica, Bahamas and the Caribbean. Commenting on this achievement, Dheeraj

Aggarwal, Chief Financial Officer, Venus Remedies Ltd, said, “Grant of market authorisation at this point of time when the innovator’s product has already gone off patent is going to be an advantage for us. We are hopeful of capturing 10 per cent of the market share within the first 3 years of our product launch.” At present, Meropenem sales account for $ 16.3 million in Mexico, of which, major share of 80 per cent is with innovator’s product ‘MERREM’ and rest with other local companies. Venus Remedies with its dedicated penems EU GMP certified manufacturing facility in Baddi, India, is all set to expand its footprints across the globe. It already has 73 marketing authorisations for Meropenem across the world while product registrations from 13 countries are under process and are expected within this year only.

Cognex’s In-Sight® 7000 series offers several integrated features

New product possess in-built features to may add value to inspection portfolio for application in space constraint environment The In-Sight® 7000 series of vision systems features powerful vision tools, autofocus, faster image capture, integrated lighting and lens and the capability to power and control a range of external lighting—all in a compact, industrial IP67 package that makes the system ideal for more applications than ever before. Users can simply set and save the optimal focus values associated with the inspection of specific parts, making In-Sight 7000 the ideal choice for production situations requiring regular part changes or projects that require the vision system to be placed in hard-to-reach spaces. In-Sight 7000 offers integrated, fieldreplaceable lighting with five different colour options, giving users total flexibility to support any vision application.  In addition, integrated field-replaceable lenses allow users to further customise the vision system for specific applications. In-Sight 7000 users can rely on proven In-Sight measurement, location and inspection vision tools and the flexible EasyBuilder® environment to make all inspection, defect detection, guidance, alignment and measurement applications easy to set up and deploy.

The company is planning to launch the product in Mexico within the first quarter of fiscal year 2013-2014. Meropenem, a broad spectrum anti-bacterial agent of carbapenem family, indicated as empirical therapy prior to the identification of causative organisms, or for disease caused by single or multiple susceptible bacteria in both adults and children with multiple serious infections including bacterial meningitis, nosocomial pneumonia, septimicemia, serious ICU infections, intraabdominal infections, febrile neutopenia, skin and skin structure infections. It is also resistant to extended-spectrum beta lactamases. Presently, Venus is already selling Meropenem in various markets and is in the process of further extending its sales operations in the most regulated markets, which includes countries such as Netherlands, France, Italy, Germany and few more.

In Brief Patent for nano-scale detection of ion channel function in lipoparticles Integral Molecular Inc, a leader in membrane protein reagents and services, announced a patent allowance covering its technology for cell-free detection of ion channel function. The US patent covers the application of Integral Molecular’s Lipoparticle technology for deriving high concentrations of functional ion channels for drug screening, antibody development and biomedical research. “Development and validation of the lipoparticle ion channel technology enabled Integral Molecular to successfully implement High-Throughput Screening (HTS) campaigns against ion channels, including the identification of novel anti-influenza lead compounds,” said Dr Benjamin Doranz, Chief Scientific Officer, Integral Molecular Inc and inventor of the technology.

Immune initiates bertilimumab phase II clinical trial in Israel Immune Pharmaceuticals Ltd, a privately held Israel company, and EpiCept Corporation announced that Immune is initiating, following authorisation from Israeli health authorities, a phase II double-blind placebo controlled study with its lead drug, bertilimumab, in patients with moderate-to-severe ulcerative colitis. Professor Eran Goldin, Lead Investigator for the clinical trial, and Director of the Digestive Disease Institute, Shaare Tsedek Hospital in Jerusalem, Israel, stated, “Eotaxin-1 is a novel target that has been validated through extensive pre-clinical and observational clinical studies.” Completion of patient enrollment and clinical results are anticipated in 2014.




News, Views & Analysis

BPS announces intention to sign All Trials petition The British Pharmacological Society (BPS) announced its intention to sign the All Trials petition. This decision underlines the Society’s unqualified commitment to the principles of transparency in clinical trials, which has been a central theme of its collaborative work with organisations in health and commercial life science settings for a number of years. Commenting on this, Professor Phil Routledge, PS President, BPS, said, “Clinical trial transparency is an issue about which many of our members feel strongly, so any campaign to encourage greater awareness should receive our support.” The full disclosure reaching back over decades, as called for by the All Trials campaign, which BPS also supports, could have major implications concerning cost, feasibility and responsibility

for enforcement. BPS will continue to work productively and proactively with partners including the Ethical Standards in Health and Life Sciences Group (ESHLSG) to understand and influence the delivery of this policy, and would encourage others to contribute in the same way. Responding to recent calls for the BPS to withdraw from the ESHLSG, Prof Routledge added, “We are aware of concerns expressed about the ESHLSG Guidelines and other issues, and are committed to working openly and consultatively with all our partners within ESHLSG to respond to these concerns, address any deficiencies and further strengthen these important documents. I would like to encourage the AllTrials campaign leadership and its supporters to actively engage in this process with us.”

Gilead’s Ranexa® may reduce angina frequency in patients with type II diabetes America-based biotechnology giant Gilead Sciences, Inc announced data from the phase 4 type II diabetes evaluation of  ranolazine  in  subjects with chronic stable  angina (TERISA) study, which demonstrated that the addition of ranolazine to background anti-anginal therapy in chronic angina patients with type 2 diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background antianginal therapy. Results were presented during a late-breaking clinical trial session at the American College of Cardiology’s 62nd  Annual Scientific Session. Ranexa®  (ranolazine) is indicated for the treatment of chronic angina. It can be used in combination with beta-blockers, nitrates, calcium channel blockers, antiplatelet therapy, lipid-lowering therapy, angiotensin-convertingenzyme inhibitor inhibitors and angiotensin receptor blockers. Chronic angina, the most common symptom of coronary artery

disease, can be a debilitating heart condition. Angina typically manifests as recurrent pain or tightness in the chest upon exertion or emotional stress. Patients with diabetes have more extensive coronary artery disease and a propensity for greater angina burden compared to patients without diabetes. “Given the high prevalence of angina in patients with diabetes, there is a need for effective therapeutic strategies in this difficult-to-treat population,”

said Mikhail Kosiborod, Associate Professor of Medicine, University of Missouri, Kansas City, Cardiologist at St. Luke’s Mid America Heart Institute, and lead author of the TERISA study. “Although the safety and efficacy profile of ranolazine is well established, this is the first study to prospectively evaluate the anti-anginal effectiveness of ranolazine in patients with chronic angina and concurrent type 2 diabetes.”

Pfizer files patent suit against Lupin, 5 other pharma firms

US-based pharma giant Pfizer Inc recently said that it has filed suit against six firms, including India’s Lupin, over patent infringement of celecoxib, the active ingredient of its branded drug Celebrex used for treating osteoarthritis. The development follows the United States Patent & Trademark Office granting Pfizer a re-issue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib. “Pfizer filed suit today against Teva Pharmaceuticals USA, Inc, Mylan Pharmaceuticals Inc, Watson Laboratories Inc, Lupin Pharmaceuticals, USA, Inc, Apotex Corp, and Apotex Inc in the United States District Court for the Eastern District of Virginia for infringement of the reissue patent,” Pfizer said in a statement on its website. Each of these generic companies previously filed an abbreviated new drug application with the United States Food and Drug Administration seeking approval to market a generic form of celecoxib in the US beginning in May 2014, prior to the December 2, 2015 expiration of the reissue patent, it added. The company said the reissue patent, which will expire on December 2, 2015, includes six months of pediatric exclusivity. The basic patent for celecoxib expires on May 30, 2014, which also includes six months of pediatric exclusivity. Amy Schulman, Pfizer, said, “We are pleased with the reissuance of this patent protecting the invention of using celecoxib to treat osteoarthritis and other approved conditions, and have initiated legal proceedings to enforce our intellectual property rights through December 2, 2015.”



Post-Budget Analysis

Did the pharmaceutical industry receive the desired boost? Dr P M Murali President, Association of Biotechnology Led Enterprises (ABLE) The Union Budget for 2013-14 is not encouraging for the biotech sector as proposed by ABLE on behalf of the industry. Although some measures are announced, overall impression of the Budget is not path breaking and is not sending the right pointers for quick growth of this sector as there are no major incentives announced by the government. While the finance minister has recognised the importance of venture capital and tax incentives, the measures announced are far from being adequate to build strong venture capital funds for the sector. We have to study the implications of the tax rebates and funds allocated for advanced skills development. From the outside one is not able to put any numbers on to this. Exemption from excise/custom duties on life-saving medicines as well as on their raw materials and exemption on capital goods and consumables, CROs, diagnostic kits have not been considered. Somebody has to realise these are important parts of healthcare. Also, there have been no measures providing tax holidays or soft loans to this sector. The heartening fact is that the plan outlay for Science and Technology has increased and there are some announcements in the agriculture area where two new biotech Institutes are coming up. More outlay to AYUSH is certainly a good step in the right direction.

Tapan Ray Director General, Organisation of Pharmaceutical Producers of India (oppi) Unfortunately, there is nothing significant in this Budget for the healthcare sector, as such. However, we appreciate the following announcements of the Finance Minister in the Budget:   Increased budgetary allocation for National Rural and Urban Health Mission may improve access. However, a planned allocation on ‘Universal Health Coverage’ initiative was highly expected. The scope of Rashtriya Swasthya Bima Yojna (RSBY) has been expanded to widen its coverage, which is also expected to have an impact in improving access to healthcare for the marginalised section of the society.  The industry also expected that the government will take measures to make all imported life-saving drugs more affordable to the patients by eliminating the import duty. Unfortunately, this has not happened.  Thus, in our view, the healthcare concerns of the country have not been given adequate importance in the Union Budget proposals for 2013-14 to help improving the healthcare needs of the nation.

Hitesh Sharma Partner & National Leader - Life Sciences, Ernst & Young Kiran Mazumdar Shaw CMD, Biocon The Finance Minister’s directional intent is good and the investment signals are positive. However, implementation and fiscal prudence still remain a concern. Bolder measures could have been taken to kick start growth as projected in the National Economic Survey. The focus on skill development through a special fund for the youth along with the provision to recognise corporate investments in technology incubators as CSR, will favour self-employment and entrepreneurship. The plethora of incentives for women and the proposed allocation for a women’s bank and the Nirbhaya fund are welcome but will have a limited impact on the overall economy.  The manufacturing sector has not received the impetus it deserves - the 15 per cent investment allowance is inadequate.   Food and fertilizer subsidies are underprovided.   The pharma sector has received scant attention. Overall, a positive Budget, which may not deliver the intended >6 per cent growth.

Not much for the pharma or the healthcare sector in the Budget. Directionally, the government has shown the commitment towards the healthcare sector by increasing spending for National Health Mission by 24 per cent over RE of last year.  Also, the continued focus on medical education and training (including through AIIMs) is positive.  Otherwise no other direct support provided in the Budget to the sector.  The increase in surcharge from 5 to 10 per cent and increase in royalty rates of tax from 10 to 25 per cent (subject to double tax treaty relief) will impact the pharma sector negatively.  Finally, the excise duty on MRP basis (with abatement of 35 per cent) for Ayurvedic, Unani, bio chemic, Siddha and Homeopath medicines, aligns these areas with the present regime for the pharma sector.  Most demands of the sector like tax holiday period increase for healthcare, GST roll out, service tax exemption for clinical trials activity, etc have not been addressed in the Budget.

Daara B Patel Secretary General, Indian Drug Manufacturers’ Association Rajendra Pratap Gupta Healthcare Policy Expert & President, Disease Management Association of India (DMAI) The fact that the first chapter of the 12th Plan document was dedicated to healthcare, in itself shows the importance of healthcare as a social mandate of National Assessment Collaboration (NAC), and the electoral compulsion of the UPA Government. Finance Minister has earmarked ` 37,330 crore for the sector in the next financial year 2013-14 budget, up from ` 30,702 crore in the current fiscal, thus a rise of 22 per cent in allocation. Emphasis has also been given to AYUSH and ` 1069 crore has been allocated to main stream AYUSH into healthcare, which is a good move. More than the increased allocations, it must be noted that this government is walking tight rope on the fiscal deficit, and I just hope that the allocated money is fully released and the absorptive capacity of the system is 100 per cent. Ranjit Shahani President OPPI and Vice Chairman & Managing Director, Novartis India Ltd We were hoping the Budget would breathe some life into the economy. The expectations of a big bang announcement to restart the economy were belied – expectations were high. Given what the market was grappling with there is a dearth of big ideas. However, it is a  responsible Budget given the fact the fiscal deficit is being brought down from 5.3 per cent to 4.5 per cent. The allocation of ` 37,330 crore to the Ministry of Health and Family Welfare is welcome, particularly the increase of 24.5 per cent over the revised estimates for the new national health mission. Innovation seems to have got some attention with the setting up of the Indian Institute of Biotechnology at Ranchi and the allocation of ` 200 crore to the Ministry of Science and Technology to help scale up innovations and make them available to the people.

An industry that our government is proud to showcase to the world as ‘Pharmacy of the World’, an industry that has earned the respect, admiration and dependence of all countries of the world for providing safe, efficacious, affordable quality medicines – has been completely ignored in the Budget. The pharma industry has been facing problems of huge CENVAT accumulation due to the inverted duty structure resulting in blockage of working capital and affecting competitiveness in international market and this needed to be addressed urgently. Considering the long-term benefits of R&D to the economy at large, all excisable goods used for R&D purposes should have been exempted from Excise Duty as also import of all capital goods to boost our R&D activities to produce and provide our people with the latest more therapeutic medicines, exemption of physician samples from central excise duty, and reduction of customs duty on all life-saving drugs, etc. The Indian pharmaceutical industry has always responded to the urgent calls of our government, both in centre and in states, in times of disaster and natural calamities by providing free medicines anywhere in India, without minding the production costs and expenses involved in reaching the medicines to those affected victims. It is sad that despite our repeated requests and representations, the government continues to tax these voluntary free medicines by imposing Excise Duty and Sales Tax on them! It has been a very lopsided Budget, in that investment allowance at 15 per cent has been allowed to manufacturing companies that invest more than ` 100 crore in plant and machinery in the next two years. Most of the manufacturing industries in India are small scale driven, with even our Prime Minister calling them ‘engines of growth’. How many companies can invest ‘more than ` 100 crore’? It effectively blocks the lakh of MSME units in India, not to mention over 10,000 units in the pharmaceutical industry from availing of this benefit. No wonder many in the Indian pharmaceutical industry now feel that it is a futile exercise to spend time and effort providing our pre-Budget proposals for drafting the Union Budget year after year, as the Finance Ministry has been ignoring the industry time and again in the last few Union Budgets.


In Conversation With


Lack of baseline research can make you struggle in business Nikunj Sharma

You left your comfortable and lucrative practice and turned to rather a challenging job, especially in India. Kindly elaborate. I always used to believe in the philosophy of more health for money than more money for health, and hence wanted to do something where we nurture and launch new ways of delivering affordable and quality care. After spearheading some of the blue-chip healthcare companies across the world my focus shifted from cost of care to improved care. Today, we help companies to cost & fund innovative programmes; build upon evidence and proven interventions, support the workforce in engaging patients and making healthcare collaborative. This is something I always wanted to do. Which areas of concern need to be addressed? Lack of evidence is a big problem. Innovations have been happening in this space for years but sometimes they do not get recognised. There are not many known ways to secure funding in initial days; opportunities exist but stay oblivious to the larger group; these are some of the factors that hinder with baseline studies leading to unfruitful innovations. We need a vehicle today to share knowledge across a diverse range of partners. This is also required for developing consensus on key messages and strategies for a cohesive approach to address the bigger problem. What do you mean by the term impactful healthcare and where do we stand? Impact is when we thrive to solve some of the most pressing problems in healthcare, ie cost, quality, real-time, on demand awareness, access and value. Impactful healthcare is when we touch a billion lives with meaningful re-configuration in our traditional value delivering excellence. With healthcare industry growing at a faster pace than ever, we have got some gold medals. Average Indian’s life expectancy is up by 4.6 years; number of infant deaths per 1,000 live births has come down to 61 from 63; government and other industry sectors have come together to boost national capacity for innovation along with academic institutions.

We are not far away from our destination, though there is a lot to be achieved.

…says Dr Ruchi Dass, Founder, HealthCursor Consulting Group, who came out from the obsession of lucrative clinics and realised the true meaning of healthcare practice after stepping into public health service. The young lady with exceptional leadership skills shares her experience about various aspects of healthcare business and practice, and how to enjoy the process of learning in the journey.

Is education an important component? Not only for the ‘fool with a tool’ but also for those being fooled ie, the poor uneducated patients. As rightly said, awareness is a big problem in India. Also, for NGOs, communication and training for healthcare workers has always been a problem. In India, most of the specialists reside in urban areas, while rural areas are covered by less qualified health workers. Wireless technology-driven health systems can serve as a powerful tool in communicating and bridging the healthcare gap because of its coverage and user friendliness. In the report that we just launched, we have mentioned several ways by which patient awareness and treatment adherence is built using technology in India. Who are your clients? Does it include government entities too? Yes, most definitely. We work with large pharma companies, small and large medical device manufacturers, providers, insurance companies, social impact organisations and government of health, both at the centre and state levels. Actually any new or old innovation that is looking to launch in a new market is our client. As our team brings some of the cutting-edge analysis from our own experience working on the ground with different stakeholders, we provides strategic insights of doing everything new in a better way. Are we blindly following the fascinating adoption to latest medicare machinery or being obsessed with advance care tools? Sometimes, due to lack of proper policies we do make expensive mistakes. However, advance care tools if used judiciously will only help us achieve better health outcomes. India, being a land of Traditional Indian Medicine (TIM), has the potential of efficient preventive healthcare. Are we ignoring it? Yes, TIM is ignored to quite an extent. Allopathy has dominated the market but there are still cures available in TIM for which people seek advice. In a ground level study, we found that the AYUSH market is badly hit with increasing imports as the market here is fighting with

Wireless technology-driven health systems can serve as a powerful tool in communicating and bridging the healthcare gap because of its coverage and user friendliness. the need of raw materials. AYUSH hospitals also have scarcity of doctors as most of them have now started practicing allopathy. With organisations such as IKP Centre for Technologies in Public Health (ICTPH) coming in, we are now using this workforce to deliver something bigger and better. The role of TIM doctors is explained in the ‘New Delivery Systems’ section of our report. The ICTPH centre employs AYUSH doctors for providing care to patients. AYUSH doctors already have much of the training required as there is an 80 per cent overlap between the curricula they follow to become AYUSH

doctors and the international MD curriculum. The project trains and certifies these indigenous doctors to serve as ‘independent care providers’ in a rural setting. In the 12th Five Year Plan, government organisations are doing a good work at promoting AYUSH interventions in public health. What is the source of your confidence? The simple thing to understand is that for so many things in life, there is no way to be certain before we act. One has to take risks. We can spend all our time trying to make things certain and wait for the perfect conditions, or we can dive in a little more. I chose the latter. Obviously, the support and overwhelming response I received made me a lot more confident. Any special memory from childhood or school days? When I was a kid I used to visit some of the swanky clinics of my relatives who were doctors. Becoming a doctor at that point in time to me was a white coat

and a swanky office. I realised the true meaning of a doctor a lot later in life when I started practicing public health. Your message to young age entrepreneurs… As Thomas Edison said, ‘I never perfected an invention that I did not think about in terms of the service it might give others... I find out what the world needs, then I proceed to invent...’. You may have a great idea but the opportunity is bleak; you may have an MBA degree but not the subject experience. Lack of baseline research can make you struggle in business. Get the basic data and existing evidence first, it will help you create value. How do you strike a work-life balance? I keep a track of my time and generally leave ‘work’ at work. I eat a healthy diet, include physical activity in my daily routine and get enough sleep. I set time aside to pursue activities that involve my partner, family and friends and all of this keeps me going.



Special Focus

EU-India Free Trade Agreement

What is at stake for

pharmaceuticals? As Free Trade Agreement (FTA) deadline is slated in April 2013 to promote trade between EU and India; major interests of pharma manufactures in India are at stake. Will the treaty pave way for improved and hassle-free drug export from India to EU? Leena Menghaney, Lawyer, Public Health & Intellectual Property and Vikas Ahuja, President, Delhi Network of People Living with HIV perform a preliminary analysis of the developments so far. ith the goal of concluding the agreement by early April fast approaching, negotiations have now reached an intense phase with regular meetings to fast track the conclusion of the EU-India Free Trade Agreement (FTA). The Indian Prime Minister has reportedly asked the Indian Commerce Minister to push the Department of Industrial Policy & Promotion - in charge of the Intellectual Property (IP) negotiations to settle their differences with the EU negotiators on IP so that it facilitates the signing of the FTA next month. This ‘settling of differences’ during a hasty and rushed negotiation process is of grave concern, as it could lead to harmful IP enforcement and investment provisions being accepted in the agreement. It also undermines the democratic parliamentary process, given there is currently a Parliamentary Standing Committee on Commerce examining FTAs, with the Indian government and the EC intensifying their efforts to conclude the EU-India FTA before the parliamentary report and debate process ends. The agreement, once concluded and signed, will become binding, and will set a precedent for IP and investment standards in all future trade agreements between India and developed countries (eg USA). It also sets a negative precedent for other developing country governments (eg Thailand) who are being pressurised to accept equally harmful IP provisions by the EU.


What concerns remain… The European Commission is now quietly  pushing the harmful IP enforcement and investment provisions in the FTA negotiations with India. IP enforcement measures  if accepted by India, pharmaceutical companies can easily abuse these provisions and use them as a commercial tactic to delay or destroy generic competitor’s medicines as it has to merely claim but not immediately prove that their IP is being infringed. These measures include legitimate medicines being blocked from leaving India on their way to people in developing countries (border measures). In addition, domestically the measures could implicate third parties — such as suppliers of API used for producing generic medicines, distributors and retailers who stock generic medicines, and treatment providers — and embroil them in court cases

Private Equity

The agreement, once concluded and signed, will become binding, and will set a precedent for IP and investment standards in all future trade agreements between India and developed countries simply for buying or distributing generic medicines. As a result of these provisions, third parties are at risk of injunctions, provisional measures and severe economic losses. The measures also seek to curb judicial activism in India as courts seek to balance Intellectual Property Rights (IPR) with people’s constitutional right to health. The EU is trying to fundamentally change how Indian courts and judges handle cases involving IP disputes on medicines. The investment chapter of the EU India FTA would further expand the ability of foreign investors (essentially, multinational corporations) to sue for billions of dollars if national laws, domestic policies, court decisions or other actions interfere with the ‘enjoyment’ of their investments –

even if the government’s actions are in accordance with its constitution and national laws. India could thereby be at risk of being sued if, for example, the government, courts or the patent office reject, override or revoke a patent on a medicine to increase access to a medicine. This is in fact already happening in Canada, where Eli Lilly is threatening to sue the Government of Canada under similar investment rules included under NAFTA because its courts revoked a drug patent considering it did not adequately meet the criteria for patentability. It is also in conflict with the current process of review that the Department of Economic Affairs is undertaking of existing provisions in bilateral investment agreements, given there is a growing threat of possible claims being filed in arbitration by investors for billions of dollars against India challenging its domestic policies, legislation and court decisions in a number of key sectors.

What needs to happen?

Vikas Ahuja

Leena Menghaney

President, Delhi Network of People Living with HIV

Lawyer, Public Health & Intellectual Property

The Indian government is in a stronger negotiation position than many other developing countries that are negotiating FTAs with the EC and the US (such as Vietnam, Brunei, Peru and Thailand). The Indian Government needs to stand strong and push hard for the removal of the IP enforcement measures from the IP chapter and the investor to state dispute provision from the investment chapter. The EU should drop its  pretense  that it supports access to medicines and is concerned about the lives of patients in developing countries. The IP enforcement agenda of the EU was evident when it started to seize Indian generic medicines on their way to Africa and Latin America. Now three years later, the pressure on India - to blindly adopt IP enforcement provisions in the FTA - highlights its continued indifference to loss of lives in developing countries. 


Special & Focus: Interface


To upgrade the pharma industry, the government should encourage more investment in this sector Nikunj Sharma

…says Didier Lacroix, Senior VP, International Sales & Marketing, Cognex. Here, he informs about the crucial checkpoints that can boost the Indian pharma industry and solutions that technology offer for tackling the counterfeit menace.

You are a key player among pharmaceutical drug verification solution providers. What are the challenges that still remain to be addressed? Although India is one of the leading countries in pharmaceutical sector, yet there does exist several reasons due to which it is behind the leader in this industry. The first and foremost reason is the lack of investment in pharmaceutical industry for which the government should take effective measures. Drug counterfeiting is becoming a serious issue and is something on which India needs to work upon. This also involves extensive investment, which seems lacking from the Indian government. Second, the R&D structure in India is in poor shape. The government is generally investing in those drugs that are already invented in other countries. There has been little or no development of new molecules or products. Hence, one should take immediate action on this to take the Indian pharma industry on the next level. Third, the end-to-end solution is not clear among the vendors, manufacturers and suppliers who are the key persons in this industry. Fourth, the customers in India lack the knowledge of understanding the authenticity of pharma products. The government should initiate some solutions so that the customer is aware that he/she is buying authenticate products from the chemist. Further, the track and trace solution is still not implemented widely in the Indian pharma industry. Devising and meeting industry-wide track and trace standards presents substantial challenges to both manufacturers and machine builders. An effective track and trace solution requires implementing three levels of functionality: print and verify, serialisation and track and trace. With this functionality in place, manufacturers can systematically print and verify marking numbers on all products, marking each product with a unique serial number and create a central database of this information. The central database allows manufacturers to track and store the location and status of each product as it travels through the supply chain until it is sold to the customer. There is no single tool capable of confirming complete authenticity of pharmaceutical products. Several verification and inspection methods need to be applied simultaneously in order to build complete confidence in the process. What is your R&D model: innovate and test the product in market or get feedback from consumers and design the customised solutions? We spent 20 per cent of revenue in

How do you categorise the Indian consumers in terms of demand for security/authentication solutions? The demand for security and authentication is low among Indian consumers. There are many products which are sold without trademark and yet customers purchase it. Also, the buying behaviour of customers displays that they are usually unaware about the product itself; they purchase it only because of being aware of the brand name or because of the doctor’s or chemist’s recommendation.

R&D, for innovating products according to our customers’ demands and need. Every year we develop new products meeting customer’s satisfaction level. We also have more than 400 patent tools, which proves COGNEX as world’s leading manufacturer in vision system. Also, we work on cost-effective solutions to meet the customer demands, with a perspective of small manufacturing enterprises, as India has the largest percentage of drug producers in that category.

The customers in India lack the knowledge of understanding the authenticity of pharma products. The government should initiate some solutions so that the customer is aware that he/she is buying authenticate products from the chemist.

Where do the Indian manufacturers lack: approach or implementation? Although Indian pharmaceutical industry ranks high among all third world countries, still it has a long way to go to achieve the benchmark of being one of the leading countries worldwide. Presently, what lacks in this industry is financial investment. To upgrade

the pharma industry the government should encourage more investment in this sector. More emphasis should be given in providing world-class manufacturing capabilities with quality and cost efficiency of production. Up gradation of R&D for new drugs and associated activities such as clinical trials and contract manufacturing is lacking and needs to be encouraged. There is also a need to develop world-class support infrastructure both for production and research. Can we dream of one solution that can serve all check points in the entire supply chain? As of now, we can dream about it, but practically it is difficult to comment on. In the coming year, definitely we would also like to see such solutions where all checkpoints are served in a single point. Gradual integration at various end-points may be the thing of future by using advanced technological support gadgets. Any recently launched product? Yes, recently we have launched a new product named Dataman 50L. It is low-end barcode reader for 1D code reading with high speed application. Dataman 50L is the smallest fixed mount image-based barcode reader. We also have launched new tool OCRMax with auto tune for fast, simple setup for superior read rates. Soon we will be launching new track and trace solutions especially for the pharmaceutical industry.

What do you expect from drug regulatory agencies? Drug regulatory agencies should initiate: Expedite the rule for secondary and primary packaging: The Indian government should take proper measurement against this. It is high time, the Indian government should confirm on the deadline of secondary packaging level. With the recent announcement of the Union Budget 2013-14, one of the priority sectors is the health sector. It will be good if the government initiates an investment in this arena, which is one of the key existing concerns of the pharma industry. Educate companies on implementing solutions and face challenges: The Indian government should take effective measures to educate the pharma companies on how to face challenges and implement solutions that are faced within the industry. Gradually increase awareness among the customer: Customer awareness highly lacks in India. We should promote this and take effective measures to educate the customers of how to understand the authenticity of the product. Especially, when it comes to drugs it is not the consumers’ convenience but their health that is being affected directly through these products, which also makes us more conscious while offering security solutions. How important is training part for using Cognex products? To use Cognex products, one does not need to be an engineer or any expert in Vision. Any shop floor level executive can plug it, learn it & and play with it. We design our products to reduce the workload and manpower involved in a specific operation, so to address the cost perspective from industry point of view is also a prime concern. What is your vision for the Indian pharma industry? Cognex vision for the Indian pharma industry is to create a one-stop solution to maintain and help to understand the authenticity of the product and to exceed consumer expectations for high-quality products at affordable price. As the Indian pharma industry is poised to lead at global platform, we are also geared up to support and serve the industry in the best possible way.



Special Focus: Roundtable

Should we push for affordable anti-counterfeiting solutions to support the strict regulatory norms in India? Pallavi Mukhopadhyay

Dr Ashifi Gogo


CEO, Sproxil Inc

Harpal Singh Director-Business Development, ACG Inspection With the recent mandate on barcoding on secondary pharma packaging, it is more than imperative for companies to strictly implement anticounterfeiting measures such as track & trace. Not only does it serve as a protective layer for supply chain security, but also empowers end-users to authenticate the genuineness at the point-of-purchase via an SMS. It also makes for longterm ROI helping track consumer insights, especially in countries with high mobile penetration. It might be really difficult to point out if a vision inspection system technology is affordable or not. Although ACG Inspection aims to bring the most advanced systems and technologies to customers at the best price, it ultimately proves to be a value vs cost argument. A lapse in ensuring maximum level of tracking and traceability could leave Several reports estimate that major pharmaceutical companies at the risk of huge loss to brand value, massive 10 per cent of the drugs sold lawsuits & product recalls, and, most worldwide are counterfeit. This importantly, patient safety. could pose not only as a huge health Even as capsules emerge as a preferred risk but would also lead to heavy loss form of solid dosage, pharmaceutical companies are trying their best to keep of revenue for pharma companies. up pace with the counterfeiters. Much Thus, it is imperative that the issue has been done on the packaging front be competently tackled by the to curb counterfeiting that has proven regulatory bodies. Experts to be successful to a large extent. Even technologies such as track & trace are opine... generating a buzz in the industry. Nevertheless, capsule printing remains one of the basic anti-counterfeiting measures. ACG mastered capsule printing, and in fact, pioneered the circular printing that allows a company’s name or brand name to be printed circularly on the capsule cap and body. Not only does this serves as a brilliant measure for anti-counterfeiting, but also doubles up as a strong reminder of brand identity in consumer’s minds. This printing is aided by capsule colouring – either two-coloured or fourcoloured – that reinforces brand image and adds another layer of security.

Didier Lacroix

Regulatory norms when supported by an actual value addition will go a long way in aiding their acceptability within the industry. If the rationale behind the regulatory norm is unclear and there is no clear communication regarding the direction in which the regulation is headed, the regulation is understandably looked at as merely a cost centre by the industry. Similar is the case with anti-counterfeiting solutions. Without clear indications and instructions from the regulators and without any communication regarding the potential benefits, regulation becomes a burden for industry. Affordability of the anti-counterfeiting solutions will go a long way in increasing their acceptability by the industry. In recent times, from our global experience, we have learnt that it is not only the high margin products that are counterfeited. A lot of the products that are heavily counterfeited in India as well as in other emerging markets are those which are widely popular but where the manufacturer has less margins; for example, generic medicines which are India’s export strength in the global pharmaceutical industry. Hence, the need is for solutions where even low margin products can be supported without having to compromising on business economics. For example, we have solutions in our portfolio which are highly customisable depending upon the need of the product and the associated investment that is viable. Such solutions go a long way in helping manufacturers choose a service which will not only protect their product from counterfeiting but will also help sustain their margins. Additionally, anti-counterfeiting solution should be able to help manufacturers win back market share from counterfeiters and hence increase sales revenue. This helps manufacturers get a tangible return on their investment and protects end consumers. For example, Sproxil has several case studies to prove the efficacy of the solution and show tangible results in terms of actual increase in revenues. This helps manufacturers in making the decision to invest in an anti-counterfeiting technology.

Divya Ranamalla Market Analyst, Goose Technologies

Senior VP, International Sales & Marketing, Cognex India, the third-largest drug production globally by volume and 14th by value, has increasingly witnessed spurious and counterfeit drugs made in China for African Countries, under the brand name of Indian drug companies. Although the Indian Pharmaceutical industry ranks high among all third world countries in terms of technology, quality and the vast range of medicines production; yet India is lagging behind other countries in the advancement of implementing 2D technology in pharma industry. In this initial stage, applying 2D technology in 2D bar coding at primary and secondary level involves a lot of investment. 2D barcoding investment includes: printing machinery, change of packaging in some cases, IT solutions which consists of both software and hardware. However, once all is sorted out in this initial stage, one can push for affordable anti-counterfeiting solutions to support the stricter regulatory norms in India. But we expect that if the government takes some initiative and give tax benefit for pharma companies then at this stage it will provide some reduction of costs.

The deployment cost for track and trace solution is relatively high. This cost would include digital printers, vision systems with 2D bar code verification software and serialisation software on every production line. Hence, affordable and scalable alternatives should be key considerations in the fight against counterfeiting while complying with regulations. The manufacturers will be increasingly drawn to simple, effective anticounterfeit measures. An affordable and highly scalable solution will result in an increase in usage, as they will look at it as a crucial investment option to minimise cost of serialisation/bar coding per production line. In most cases, the manufacturers prefer solving a specific problem by implementing a small project in a limited period of time. . The basic track and trace is a strategic solution that not only addresses the immediate requirement but can be expanded in phases over a period of time, increasing the benefits and ROI with each phase. This initiative is positive and in a country such as India, where multiple products are manufactured by a large number of companies and exported to various countries across the globe, this would ensure safer and genuine drug distribution and higher value to all stakeholders.

Editorial take It is possible to deploy simple cost-effective measures in order to curb counterfeiting. Regulatory laws should be included in the quest to maintain a healthy brand image of India in the international market. Such measures will go a long way in helping pharma manufacturers do so. More companies must look at investing in low cost and customisable anti-counterfeiting solutions. This will in turn help manufacturers regain the losses incurred due to such counterfeiters.


Insight & Outlook: Policies & Regulations


Indian pharmacy drug stores

Need to have a strict regulatory system The retail pharmacy drug sector in India is largely dominated by the unorganised sector, while organised pharmacies are limited to urban areas. In order to remove sub-standard medicines from the supply chain, the government needs to check on the conventional link between the patient and the drug ie, the pharmacy stores.

Nikunj Sharma

ff late the Indian pharma retail sector has witnessed a spurt of large online pharmacy chains. However, their limitation to metros and tier-I cities leaves plenty of room between them and the sub-urban as well as rural consumers. Citing the myth of ‘India as a Hub for Spurious Medicines’ that continues to tarnish the image of our nation in export markets, and in the middle of market-related concerns p at i e nt h e a lt h is more important. Discussing the state of Indian pharmacies, Bejon Kumar Misra, International Consumer Expert & MD, Consumer Online Foundation, says, “In March 2002, the Indian Pharmaceutical Association prepared guidelines for India on Good Pharmacy Practice (GPP) and in the preamble did not hesitate to mention that many in the profession are looking for someone to blame rather than deciding what they can do to move forward. The Indian Parliament has always demonstrated its commitment towards the health and safety of the consumers by enacting excellent laws but has failed miserably to implement the laws efficiently. It is blatantly visible in India; how consumers easily self-medicate by procuring any type of antibiotic medicine or sleeping pills without any prescription from qualified medical practitioners!” Retail drug stores are the most prevailing channels of distribution with a wide outreach to Indian customers, which is mainly categorised as organised and unorganised segments with different retail formats. The unorganised segment consists of brick and mortar model of old shops that cater to almost each segment and territory under dealer, wholesaler and retailer mechanism of typical market infrastructure. On the other hand, the organised sector is governed by several pharmacy chains owned by leading players in India, which is mostly confined to the urban populace and areas. The retail pharma market in India is large by size with considerable prospects of


growth, as country’s organised pharmacy sector accounts for just 20-25 per cent and concentrated in urban areas only. Tier two and rural markets are the potential growth drivers. “In 2002, when I conducted a study for the National Pharmaceutical Pricing Authority (NPPA) on Prices and Accessibility of Medicines in India, it revealed that more than 70 per cent of the consumers are purchasing medicines without any prescriptions or supporting documents. In the same study the consumers confessed that it is extremely convenient to treat their ailment by visiting pharmacy drug stores rather than consulting a medical practitioner. They also mentioned that many a times due to non-availability and affordability issues, consumers depend heavily on the pharmacists to swap the prescribed medicines with such medicines, which are recommended by the

The community pharmacy is the best friend of the consumer but the trust and faith cannot be misused for commercial gains. Bejon Kumar Misra International Consumer Expert & MD, Consumer Online Foundation

pharmacy drug store and consumers do not find it risky because of the strong faith and relationship they have with the local community pharmacy,” informs Misra.

Market: Prospects and Issues According to an AIOCD report, the total sales of drugs in India reached ` 53.69 billion during the FY2011-12. The sector has about 700,000 pharma retail stores, out of which around

25 per cent accounts for organised retail segment. The investment from Indian pharma companies has grown in the last few years, and with FDI in retail the growth prospect looks positive. The retail pharmacy stores are expanding their outreach in urban and rural areas. Misra emphasises, “These are serious health and safety issues and in my view the culprits who contaminate the supply chain with spurious and non-standard medicines sustain the business through such irresponsible pharmacy drug stores. It is high time the regulatory mechanism existing in India start penalising heavily all such pharmacy retail outlets who violate our existing laws by enabling consumers to access prescribed medicines without valid prescriptions from qualified doctors. The regulator has to take stringent action against poor documentation systems and non-adherence of proper storage facilities such as cold chain and dark rooms. The community pharmacy is the best friend of the consumer but the trust and faith cannot be misused for commercial gains.” The new trends that are emerging to deliver enhanced retail services include Value-Added Service (VAS), teleconsulting service, investments made by organised players in retail pharmacy, loyalty schemes, counterfeit drug tracking, government’s involvement in pharmacy retailing, growth of private labels and pharmacy outlets in rural areas and availability of health insurance kits across the drug stores. The wide fragmentation of the retail pharmacy sector will be a major challenge in addition to the complex supply and distribution chain comprising various stakeholders as well as the circulation of spurious drugs. Speaking in an open house consultation ‘Accessibility to quality medicines in the supply chain’ organised by PSM India, Praful Naik, CEO, Bilcare, informs, “Counterfeit is a global

The investment from Indian pharma companies has grown in the last few years, and with FDI in retail the growth prospect looks positive.

Major drug retail chains in India Apollo Pharmacy: Owned by Apollo Hospitals and is the largest chain with more than 15,00 pharmacy stores. MedPlus Health Services: More than 980 retail pharmacy stores in India. Viva Pharmacy: A venture by Surya Pharma; owns stores and plans to foray into franchisee business. Fortis Healthworld: Promoted by Ranbaxy with self-operated and franchise business model, and plans to open over 900 retail drug outlets. menace even in developed countries. Counterfeit drugs are being manufactured in other locations outside the country, labeled as ‘MADE in INDIA’, especially bulk medicines. Track and trace is a step to counter the challenge of spurious drug circulation. A scan should be able to provide all traceability aspects of the scanned product. There needs to be a centralised system to serve the purpose and ensure authentic track and trace across the globe. Compliance adherence is the future challenge in India.”

There needs to be a centralised system to serve the purpose and ensure authentic track and trace across the globe. Compliance adherence is the future challenge in India. Praful Naik CEO, Bilcare

Measures to adopt In September 2012, AIOCD submitted a letter to NPPP for finalising the drug pricing policy in order to fix the cost of essential drugs for retail market. The demand was made to eliminate uncertainty over price and address the patient needs. Apart from the pricing, the government also needs to address the operative modes of drug retailing as non-

prescription drugs are directly affecting the consumer’s health with a view of supply and demand gap for the affordable and quality medicine. “We must recognise all such retail pharmacies which adopt Good Pharmacy Practice as published by World Health Organization (WHO) through a certification process, so that consumers can make an informed choice and seek several facilities from such stores. The regulator has to involve all the stakeholders, especially the consumers, to ensure they buy only from stores that sell only through prescriptions and provide evidence of sale. This will ensure quality and safety to the consumers and eradicate the menace of spurious and non-standard medicines from the supply chain and make the regulatory mechanism in India credible and patient friendly. It is a Consumer Right issue as mandated in the Consumer Protection Act 1986,” avers Misra. Werner Horn, CEO and Co-Founder, Securikett, Geneva, said in the PSM conference, “There are various measures being implemented to address the issue of substandard drugs in the supply chain such as hologram, SMS verification, online verification number etc. But not a single solution can solve this issue; a series of measures at different stages of drug supply chain may bring down the circulation of substandard medicines up to a significant extent.” From technology perspective the retail chains are luring more consumers through offering VAS and loyalty programmes apart from Customer Relationship Management (CRM), Supply Chain Management (SCM) and Enterprise Resource Planning (ERP). The presence of spurious drugs is a major concern among all stakeholders and needs to be addressed urgently.



Insight & Outlook: Interface

Despite having the necessary provisions, the SMEs cannot derive benefit from the policies laid by the government Pallavi Mukhopadhyay

…says Kiran A Badgujar, Managing Director, Mack Pharmatech Pvt Ltd. Whie discussing the current scenario of SMEs in the country, he lays down the ground rules for further growth of this segment.


With Small and Medium Enterprises (SMEs) on a rise, how do you see the future opportunities for this segment? India’s pharmaceutical industry comrpises a number of large, medium and small enterprises, and is one of the world’s most cost-competitive industries. It is also extremely fragmented with 25,000 plus domestic manufacturing units. With increasing drug patent expiration slated during the next 5 years, gradual decrease in new product offerings and with increasing significance on the use of generic medicines in developed countries, the competition in the global pharmaceutical industry is set to get steeper. According to a latest report from McKinsey & Co, the value of the average patent expiry in 2010-15 would be $ 39.6 billion per annum. Indian pharmaceutical companies will have a favourable role to play in this transmuting scenario; the medium and small players are anticipated to chalk out an influencing role for themselves. In spite of the decreased R&D investments, small and medium players seem well on mark to take on the global challenge. Almost every India-based top pharmaceutical firm will stand to get benefitted by introducing generic forms. There are greater possibilities of alliances among Indian-multinational pharmaceutical firms for producing, sourcing of generics and bulk formulations, which would then be sold in the emerging and developed markets. Various new ways of garnering opportunities have come up for the SME sector. An emerging trend in these segments has been evaluated to further engage in clinical trials, either on contract basis or on their own capabilities. The Contract Research and Manufacturing Services (CRAMS) opportunities are also coming down to small and medium players who have got experienced and facilitated with norms of regulatory agencies. New product launches from the bigger players help the SME players to gain contracts for manufacturing and also provide opportunities to supply API and other chemicals. Furthermore, a marketing approval of generic drug products provides opportunity to SME players to increase their drug product portfolio. How has the production and trade grown for SMEs in the last 10 years? The existence and growth of SMEs is a salient component of industrial structure in India. The contribution of SMEs to pharmaceutical units, output, investment and employment is considerably higher than many other sectors. Going by the past few years, the growth of domestic pharmaceutical industry has outperformed that of the global pharmaceutical industry. What are the infrastructural challenges SMEs today face? SMEs in the past were more focussed on investing on applications and servers,

but today this has changed. These days they are seeking out for more advanced technologies as well. SMEs are the backbone of the nation’s economy. They contribute to the industrial output, provide million of employment opportunities and produce thousands of quality products for the Indian and international market. It constitutes an important segment of the Indian economy. Also, due to globalisation of markets and competitive developments SMEs today face a lot of challenges. This requires companies investing in infrastructure, which is flexible, scalable and at the same time offer investment protection. One of the important aspects of SME’s infrastructure is the communication systems which they deploy. The company establishes its credibility, image over a period of time and communication works both as complimentary and supplementary to that. The impact of communication is unquestionably clear in the varied sectors of corporate business. The SMEs need a sound communication platform that allow them to collaborate with the key demographics despite geographical distances. A platform that would help such entities in effective communication with associates, partners and investors located across the globe would help the SMEs establish a presence network and enable its clients and associates to stay connected. How can the government aid in bringing about further growth of the pharma SME sector? The minimum government investment limit for small scale units has been up from ` 1 crore to ` 5 crore, which can go upto ` 30-40 crore. This is a major scope for investments by MNCs and entrepreneurs in the pharma sector in the country. MNCs view this as an

opportunity and there is a positive chance that they would invest in R&D as well. The government is doing its bit effectively by bringing out the required policies and regulations. Here, the problem remains that these are not properly implemented. Despite having the necessary provisions, the SMEs cannot derive benefit from the policies. For instance, the government is offering ` 15 lakh to companies for renovation and up gradation of the technology. The government has also set up a promotional package for Small Scale

The contribution of SMEs to pharmaceutical units, output, investment and employment is considerably higher than many other sectors. Industries (SSIs). But the formalities and the complexity of the procedure is such that eventually a company cannot take any benefit from the initiative. The beneficial schemes are already in place but there is lack of implementation at the ground level. The most important support for the Indian pharma SMEs will be development of the infrastructure. There is a serious need to develop the connectivity, especially the roads in rural areas, which are inaccessible. The government also needs to pay attention to development of sewer systems, drinking water facilities for the SME pharma companies to grow. Are SMEs today fully exploiting their export potential? SMEs account for more than half of industrial production in developing countries, although their share in exports is usually lower. With proper guidance

and assistance, more SMEs could turn out to be more efficient exporters. To do this, it is necessary to establish close co-operation between government, its promotional institutions and the business community. High SME growth rates have been reported in countries in which such relationships have been established. How can SMEs start innovating further? Innovation is crucial for a company to get started and then grow. The development of new structures, differentiating oneself, improving performance and creating value are constant concerns. That is why associating SMEs with innovation makes so much sense. The research work of the innovation and SMEs team focuses on four areas: SMEs and the innovation environment: This area studies the role of SMEs in innovation projects and the role of state facilities on the performance of very small companies and SMEs. Standards, quality management and SMEs: quality standards can serve to entrench the credibility of SMEs, organisations in which the lack of resources, the concentration of decision-making powers in the hands of the director, and the possible lack of critical skills are counteracted by the flexibility of the firm’s structure and its ability to act swiftly. Before SMEs are formed, the creation of companies (or entrepreneurship) is constantly encouraged by state institutions in the same way as the creation of ideas and the seizing of opportunities (or intrapreneurship) are constantly encouraged at the very heart of corporations. Management of SMEs during times of crisis: The management of SMEs during times of crisis demands innovation while management tools are put to the test.


Insight & Outlook: Roundtable


Is the race for generics stifling innovation in Indian pharma sector? Hardik Ashar

Dr Prakash Diwan

Dr Anil Gupta

President, Indian Pharmacological Society

Executive Vice Chair, National Innovation Foundation It is true that many big R&D pharma companies have folded back their special purpose research centres, reduced number of PhDs they had for the internal R&D and have gone aggressively in pursuit of profits from generics. At the same time, it is also true that many smaller companies have started filing patents on drug delivery system or better formulations. Interestingly, patent wars have begin around such Indian innovations. But by aping the western models and heuristics, breakthrough are unlikely to be achieved. Indian companies should aim at pursuing systems biology approach with multi-molecule multi-targeted drugs rather than single moleculebased drugs. The regulatory authorities must modify their protocols to not only permit such drugs but also to encourage it. This approach is closer to what nature does anyway. They may try to see distributed model of R&D using platforms such as A cost-effective ‘techpedia’ developed by Society for Research medicine seems pleasant and Initiatives for Sustainable Technologies to the pocket if not the palate. and Institutions (SRISTI) to engage budding While generic drugs keep medicine talents. About 3,000 cultures developed by SRISTI in its lab have been leveraged by affordable for the consumers and the Department of Science & Technology generic drug makers happy, these for identifying new generation antibiotics. apparently do not lead to encouraging The open source platforms such as innovation. With several domestic ‘Open Source Drug Discovery’ needs to be replicated. Likewise, patent and open companies joining the ‘me too’ race, the source can co-exist to encourage derivative critical question is whether we are innovations. Another area where Indian losing on an innovation drive for innovation can focus is herbal medicines drug research. The experts but current policies as well as institutional support is rather muted or weak. It can be made brainstorm... much more vigorous and I will not be surprised if major breakthroughs come in this space. National Innovation Foundation in collaboration with Indian Council for Medical Research (ICMR) has identified promising leads for typhoid and other diseases using such an approach. New models of collaborative research are the need of the hour.

In recent years, the Indian pharma industry has seen phenomenal growth outfacing the competition and due to strong demands for the export. The industries have made a tremendous progress in terms of infrastructure, technology and have produced cost-effective drugs with world-class manufacturing facilities. Industry has mastered Good Manufacturing Practice (GMP). Headache is looming on innovation-based pharma giants as generics is entering into the market. Branded drug makers are worried about lower profits, increasing cost of developing new drugs and patent cliff. The generic manufacturers have gained from the off patents of blockbuster drugs. It is unfortunate that drug discovery in Indian Pharma has taken a back seat and not a single drug has come in the market as New Chemical Entity (NCE). Pharma sector in India has no financial muscle to develop drugs and the R&D efforts are out licensed for their development by MNCs. New drug discovery and development has not reached its full potential but many NCEs are in the pipeline. Hence, we cannot say that India has failed in innovation of NCEs but the future can be brighter for innovation. Generic drugs in India account for approximately 50 per cent of essential medicines. The reverse engineering, copycat, imitation and leadership in generic market made Indian pharma to fight the legal battles with MNCs. However, there are even few generic drugs that have the same price as that of the innovator. Reverse engineering has evolved as great boom for Indian pharma and is a form of innovation that has been mastered. Strength of manufacturing quality generic drugs inculcated the confidence to challenge the patents from world’s multinational pharma companies. Based on the above facts, one or two NCEs from India as innovative drugs will not make any difference to the global innovators and generic makers.

Dr V N Balaji Dr Rajesh Kuppuswamy Senior Director - Consulting, Life Sciences, Cognizant Seldom has innovation been stymied because of imitators going after a proven model or product. Leaders innovate, have a high appetite for risk and typically reap greater rewards. Followers are typically content with making their mark with efficiency. In the 1980s and 1990s, rewards were high for innovator pharmaceutical companies. There was little innovation (multiple ‘me too’ products) and the regulatory environment was soft. Payers did not wield as much power, patient advocacy groups were yet to evolve and social media had not made an appearance. All these helped reward branded drug companies. Therefore, the spotlight was not on generics. Today’s environment has changed. Branded drug companies are building their own generic strategy, thereby shrinking the margins in the generics industry. In these circumstances, Indian pharma needs to define its own identity. Cost arbitrage will continue to shrink, while political and regulatory pressures continue to rise, casting a doubt on the ability of Indian pharma to be content with generics. There are two ways forward: either continue in generics in partnership with MNCs or explore other business models that include discovery, pre-clinical and so on. Taking a molecule through regulatory filing may still be some time away.

Drug Discovery Consultant India is a country of 1.2 billion population and more than 40 per cent living below poverty level. Country’s healthcare still largely and heavily depends on government hospitals. Drug discovery requires many years, tremendous funds and top talent pool. To hit one drug to market from scratch requires about 12 years plus at least few billion US dollars. Keeping a dedicated scientific team is a big challenge for any company. Worldwide, lack of many blockbuster drugs in last decade has pushed industries to seek mergers and acquisitions and collaboration with universities to reduce R&D cost and get new insights. In India, many pharma companies successfully ran active pharmaceutical ingredient production business and kept a leadership position in that area. Though many of them and others have ventured into drug discovery, few companies have created potential drugs from their internal portfolio. Few companies have shown wholehearted commitment to bring such projects to fruition. The issue of recent compulsory licensing has not favoured the investment needed for drug discovery and development and would encourage companies to be in generic space. To promote innovation the government must develop and set up policies that strongly support intellectual property rights.

Editorial take While India has evolved as a ‘generic king’ in the global pharma industry, changes in patent laws have forced Indian companies to fuel their innovation tank. The pharma industry in India is still in its infancy when it comes to basic drug research. Hence, Indian companies must leverage its cost advantage and talent pool to bring in newer, original and innovative products.



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

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,l’-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Urease on its one end and to a voltage measuring device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Formulation for leucoderma It is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease

is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application Pharma and medical industry Transfer terms Joint Venture, technology licensing, research partnerships Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side-effects are reported to be the advantages of this product. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Process of preparation of nanoparticles for drug delivery system The present invention is related to a process for the preparation of the novel nanoparticles of apotransferrin or transferrin which are useful for the preparation of a pharmaceutical composition facilitating easy delivery of the drug. Areas of application Medical and pharma industry Forms of transfer Technology licensing Pharmaceutical composition for the treatment of ophthalmic disease A company can offer technology for manufacturing a drug useful in the treatment of opthalmic disorders. A composition comprising Lithium chloride is the product which causes retinal cell regeneration. Areas of application Pharma and medical industry Transfer terms Consultancy, technical services, technology licensing

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

Manufacturing technology of hepatits B, tetanus, diphtheria and pertussis vaccines An Indian company is interested in a complete technology for start up of manufacturing of combination vaccines from bulk to formulations including supply of protocols for manufacturing and production strains. Areas of application Human vaccines Transfer terms Others

Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others

Manufacturing of liquid bio fertilisers An agro biotech company is looking for a proven technology for manufacturing of liquid bio fertilisers. They would like to know the kind of technology that could be offered and a procedure of buying the technology along with the cost incurred. Areas of application Biotechnology Transfer terms 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 Manufacture of intravenous fluids A company requires know how and technological requirements for the manufacture of intravenous fluids. Know how should include where to obtain appropriate grade raw materials. Areas of application Pharma/medical Forms of transfer Others

Manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid, D-biotin A company needs API/bulk drug manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid and D-biotin Areas of application API/bulk drug Forms of transfer Others Pharma grade mannitol knowhow A company is on the look out for a commercially proven latest technology & know how (turnkey) mannitol in India. The estimated production capacity is 600 tonnes per annum. Areas of application Pharmaceuticals Forms of transfer Others Pharmaceutical Lyophilisation plant A Peru based company is looking for a Lyophilisation plant for pharmaceutical use. Capacity shall be around 175 to 200 square feet, for the lyophilisation of 20,000 vials of 10 mL per day. Areas of application Pharma and food processing industry Forms of transfer Others





New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry.

Developing radiation health service infrastructure Project type: New facility Project news: A nation wide increase in the diagnostic and treatment services available in Nepal, in particular regard to cancer services. Institutes involved Ministry of Science and Technology Location, Kathmandu Ministry of Science and Technology, Science and Information Technology Division Location, Kathmandu Ministry of Health & Population.

Diagnostic centres Project type: New facility Project news: Medizinisch Diagnostiche Institute (MDI), one of the worlds largest diagnostic testing services, has proposed to invest ` 150 crore in its Indian subsidiary MDI Laboratories with plans to set up over 2,000 collection centres as part of expanding its network in Karnataka, Maharashtra and Gujarat. It plans to set up 2,000 collection centres in the next two years and a logistics network to transport samples and expand its network in Karnataka, Maharashtra and Gujarat.

Project location: Kathmandu, Nepal Project cost: NA Implementation stage: Planning

Project location: Karnataka, Maharashtra and Gujarat Project cost: ` 150 crore Implementation stage: Planning

Contact details: Ministry Of Science And Technology Singha Durbar, Kathmandu Nepal Tel : 977-1-4211637 Fax : 977-1-4211754 Email :

Contact details: MDI Laboratories 3G/2, Court Chambers, 35, New Marine Lines, Churchagate, Mumbai - 400 020 Tel. :+91-22-2206 5748 Fax :+91-22-6634 6124

E-mail : Web

Implementation stage: Planning

Establishing a radiology diagnostic center for Ali Abad Teaching Hospital Project type: New facility Project news: Ministry Of Foreign Affairs is planning to establish a diagnostic imaging centre for Kabul.

Contact details: HMT Limited 59, Bellary Road, Bangalore - 560 032, Karnataka, India Phone: +91-80-2333 0333 Fax : +91-80-2333 9111 E-mail :

Project location: Kabul, Afghanistan Project cost: NA Implementation stage: Planning Contact details: Ministry of Foreign Affairs of Afghanistan Malek Asghar St. Kabul, Afghanistan Tel: +0093 (0) 20 2100372 +0093 (0) 70 0104173 Fax: +0093 (0) 20 2100 360 Email: Multi-speciality hospital Project type: New facility Project news: HMT Ltd is planning to start a super-speciality hospital in its unit at Kalamassery in Eranakulam district. expects to start work on the hospital next year if its search for partners turns successful. As per the company’s rough estimate, the project would cost ` 400 crore. Project location: Kalamassery, Kerala Project cost: ` 400 crore


Set up Apollo proton therapy centre Project type: New facility Project news: Apollo Hospitals Enterprise Ltd has announced that the firm has inked a contract with Ion Beam Applications (IBA) worth almost ` 400 crore, to set up a proton therapy centre for cancer therapy in the country. IBA would supply dosimetry equipment for safe and fast commissioning of the centre to offer the technology available for patients from 2016. Project location: Chennai, Tamil Nadu Project cost: ` 400 crore Implementation stage: Planning Contact details: Apollo Hospitals Enterprise Ltd #19, Bishop Garden, Raja Annamalaipuram, Chennai, Tamil Nadu 600028 Tel: 044-28290956, 044-28293896 Fax: 044-28290956 Email: Website:




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rewards as well... Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

16-28 Febru ar y

2013 I Vol 1 I No 16 I `100


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In Conversa

tion With 16

K V Subram aniam President & CEO, Reliance Life Sciences

Bhasker Iyer Vice Presid named Divisional Pharmaceutent, India - Abbott icals Busin ess

Special Focu s 18 The cleanoom market in India Set for big growth

Interface 27 Sheesh Gulati Chief Executi ve Officer, MeasureTest Corporation

Policies & Regulations 28 FDI in pharma : Embrace or fear? Anup P Shah Partner, Pravin P Shah & Co

SCHOTT fully automKAISHA inaugurates ated plant ia’s ďŹ rst for pharmInd a packaging

Bhasker Iyer has With the pharm been named aceutical market expanding Divisional in India by approximately He added, cent per year, 14 to 17 per Vice Preside “Our new the packag nt, state-of-the-a factory sets expected to ing market India rt standa new standa grow is This rds turn us rds in India. investment pharma market in line with the overall Commercial into the ideal will result for India’s Iyer quality opport partne ambitious in better annually. Keepin by about 11 per Operations, unities for and fast growin r cent In pharmaceutic g in mind our custom other needs of the al industry,� g Abbott ers. Establ ished industry, SCHO the growing Indian words, we will be he added. SCHOTT helping the inaugurated KAISHA is TT pharmaceutic effective Februa Pharm aceuti cals, exceeding its new pharm KAISHA achieve overall market confident of packaging its own growthal industry to aceutical Iyer will report ry 18, 2013. Bhaske plant in Jambus future with growth in objectives.� r The Gujarat. This the ar, Vadodara, expectations new plant Executive Vice into Mike Warmuth, ` 240 crore in Jambus greenfield produc ar has 20 ` 135 crore mark by the of crossing Pharmaceutic President, Established is set to increas investment of vials, tion lines for ampoules The Indo-G end of 2013. als Divisio and with e produc erman compa the company’s 16 for scope tion capacit n, Abbott. Iyer brings ny offers over Its fully automa for further expans cent to around y in India by 50 a ion. in the pharm 30 years of experience ted produc per uses 2 billion ampou tion a high-en vials indust process per year. d robotic feeding ry. the positio les and for tube-loading n of Presid He held technology This packag and Emerg ent, India ing plant camera inspec as well as high-precision ing an existing complements Abbott’s pharmMarkets, Wockhardt. production market leading tion systems. World facility in Daman aceuticals and enhanc in India SCHOTT FIOLA business es SCHO Abbott India are used TT KAISH competitive XŽ tubes Healthcare Ltd, Abbott A’s India’s as base material. The advantage Solutions With high-e facility substantially first pharm and Abbot True Care nd safety aceutical packag is - will report t precautions . plant meeting global place and into this newly ing established a in ISO 15378 standards positio GMP, SCHO strong commitment with an certification. with the busine n. Iyer will work (L-R): Prof to TT KAISH Ungeheuer; “KAISHA’s ss leadership completely A’s Dr Juergen Dadachanji 20 to identify deep acre about automated teams Sackhoff, EVP, market knowle and further opport Systems at plant revolutionise India and Pharmaceutical dge expand access the inaugur unities to SCHOTT’s India’s pharm is set to techno ation world-class to Abbott’s industry. SCHO logy create a packaging portfolio of a perfect partne complete broad TT KAISH empha quality produc range of aim remain Warmuth said, ts in primar s to serve the A’s primary Chairmsises Prof Udo Ungehrship,� glass packag “The establis India. Indian market an of the Board ing: Produc y tubular “We see a euer, ampou this positio hment . SCHO steadily rising of Management, of n reinforces les, vials, cartrid ts comprise for locally TT AG. demand the focus of the compa ges for pen auto injecto manufacture ny’s highly commi “The SCHOTT group and packaging rs as well d primar bring quality strategy in India to is fillable tted to its that meets as sterile y pharmaceutic business. Our glass syringe medicines the rising predemands,� al “Altho s. that make continuous quality to patients said Kairus India demon a differe ugh our mainDadachanji added, investments Managing in curren strate our and to ensure nce in their lives Director, SCHO Dadachanji, than concen ambition. one patients and TT KAISH More syringetly on ampoules and tration is healthcare A. in setting hundred years of the vials, the community market experie the world’s has access these medici highest techno nce healthy growth is expected to see to nes.� a in the near logy future.� Pallavi Mukho Tata Capita padhya l acquires minor The y interest in Marck Pharm aceuti cals Promo tion Biosciences ity Tata Capita Expor t l Healthcare (Pharmexcil) Counc il of India acquired Fund has annou minority launch of interes per cent in iPHEX 2013. nced the Marck Bioscie t of 13 ‘India’s own Billed as along with nces Ltd pharmaceutic 6 per this event al show’, Venture making cent stake in IFCI will be held total stake from in Mumb April 24-26, holdin 2013 with ai support of Tata Capitag the from the Ministry Commerce between 19 l & Industry, of to Department Commerce 22 per of and Govern cent ment of India. Over 400 in Marck leading Indian are expect Biosciences. ed to showc companies of pharm Bhavesh Patel, a products ase the best before 5,000 business visitor MD, Marck Patel s including buyers and Dr Appaji address Biosciences, overse drug regulat as ing the seminar ors. is expected said, a sustained to offer a good The event be a growth phase “It is complete value for interna opport Marck Bioscie for us at unity tional chain show Pharmexcil nces as we to visit India buyers and regulat and is creating are investin ` 80 crore in ors pharm “iPHEX 2013 and evalua g the a sustainable a industr structured te how well will be The fund infusionew expansion project indust ry and . focus on exporty platform with a special exposi tion the biggest pharma indust regulated the Indian will be investe n from Tata Capital market develo showcasing in India ry is at the The export d for further the diverse pment. According moment. s growth story of capacities expans products and range of ion proud of.� of the new is one to be will include 2013 will to Pharmexcil, iPHEX project, which will have APIs, formulations, immensely state-of-the-ar With increas Ayush members help its t technology. Our entire nutrac eutica ing health service , to R&D promo spends, Indian pharmaceutica project cost ls, te the quality and afforda to be around is expected l biotec hnolo s, biotechnology and bility aspect effective centre sector has become a costgy produ in ‘Brand as envisag we will also ` 80 crore and hence for world-c service India ed cts, R&D s also lass Pharma etc,� inform be research as for contract The campa funding throug going in for further ed Bhavin R&D. Indian Comm ign has been Campaign’. in recent Mehta, Ministry of years have produc companies Memb ittee Chief, iPHEX initiated by returns from h debt route. We expect Commerce and er, effectiv ed the funds infused CoA Pharmexcil. many coste drugs that by Pharmexcil and execute 6 to 8 month within are d masses Pharmexcil s.� . In this context affordable to the Brand Equity in association with India severa l thema plans to organi , Foundation. Ashuto Vice sh Gupta, se Chairman, tic semin Dr P V Appaji Pharmexcil, conferences are making , Directo on the sidelin ars and Pharmexcil, concerted efforts said, “We “These said, “iPHE r General, India’s es as well. will to promo include pharm status as X 2013 will te investm a sector of the world.� the manufacturing hub ents, overseas markeR&D and innovation, added Mehta t entry strategies etc,� .

iPHEX 201

3 to host over

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Event List


N AT I O N A L E V E N T S Pharma Pro&Pack 2013 PHARMA Pro&Pack Expo 2013 will offer an opportunity to expand business in the Indian and international pharma industry. Various industry majors from India and across the world will be present at the Technology Show. The event will help facilitate meetings with clients & prospective customers at one place on one platform thus expanding business to new customers locally & internationally; April 24-26, Bombay Exhibition Centre, Mumbai For details contact: GPE Expo Pvt Ltd Tel: 91-79-40008253 Email: Website:

iPHEX 2013 iPHEX plays a major role in introducing the Indian market to the advanced medicinal products. This show covers up the entire medical industry, starting from hospital services, medicines, pharmaceuticals and surgical sectors. 250 companies have already registered to participate in this event as they think that this podium is best way to reach out to the customers and publicize their brand name; April 24-26, 2013, Bombay Exhibition Center (BEC), Mumbai For details contact: Pharmaceuticals Export Promotion Council Tel: +91-40-23735462/23735466 Fax: +91-40-23735454 Email: Website:

ADME & Toxicology 2013 and ‘Nanomedicine’ conference and exhibition The conference will provide attendees with a learning and networking environment where they can share and discuss the latest developments in the field of life sciences. This conference will aim to provide a multidisciplinary approach to tackle the fundamental challenges in this specialty, innovative strategies for testing exposure, and techniques for improving the reliability and accuracy of results. The keynote speakers will give presentations on all areas of nanomedicine backed up by a panel of experts speaking on highly relevant and ‘hot’ topics such as green nanotechnology, nanomedicine in theranostics besides discussing topics such as novel synthetic approaches in nanomedicine, nano-delivery systems and regulatory and toxicology aspects in nanomedicine; May 30-31 2013, Raddison Blue Plaza, Delhi For details contact: Select Bio Ltd Tel: +44 (0)1787 315110 Fax: +44 (0)1787 315111 Email: Website: conferences/index.aspx?conf=ND2013

PHARMAbiotika Pharmabiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking 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


Andhra Pradesh, May 31- June 3, 2013 India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. R5&95fhh5iffi5jlkg5R5295fhh5iffi5jjoo5R5'#&95(!2*)H(.1),%gn*/&#-"#(!8)'

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 For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 – 6528801 Email: Website:

Indian Pharma Expo The Indian Pharma Expo 2013 will be one of the a unique pharma events inIndia that will serve as a perfect platform for pharma entrepreneurs andinvestors, 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 the largest suppliers and distributors of pharma products under one roof in order to facilitate the exchange of ideas for better growth of the industry; 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: Website:

34th International Conference on Bioscience, Biochemical and Pharmaceutical Engineering The main focus of this conference is to bring scientists, researchers and scholars together to exchange and share experiences and research results about bioscience, biochemical and pharmaceutical engineering, and discuss the practical challenges encountered and the solutions adopted. The conference will deal with topics such as bioscience, biochemical and pharmaceutical engineering, affective neuroscience, astrobiology and more; December 5-6, 2013, Sheraton, Bengaluru For details contact: World Academy of Science Engineering and Technology Tel: +44-782-4879405 Website: conferences/2013/bangalore/icbbpe/

I N T E R N AT I O N A L E V E N T S 8th Annual Drug Discovery Chemistry Conference This is one of the few events specifically for medicinal chemists working in pharma & biotechnology sectors. It is focused on discovery & optimisation challenges of small molecules. Nobel Laureate will give the keynote address. The meeting will discuss Anti-Inflammatories, Fragments, Macrocyclics, Kinase Inhibitors, PPI & GPCRs. The event offers opportunities for scientists to create unique programs according to personal interests; April 16-18, 2013 Hilton San Diego Resort & Spa, San Diego, CA, USA For details contact: Cambridge Healthtech Institute Tel: +1 781-972-5400 Fax: +1 781-972-5425 Website:

Pharmaceutical Research Conference for Pharmacy Students & Young Graduates Themed ‘Meeting of the inquisitive minds: translating research into reality’, PRC 2013 is set to be the arena for pharmacy students & young graduates to showcase research & interact with other young researchers to ignite interest & exchange ideas. The conference will provide an environment for pharmacy students to present their research work and share their knowledge. Participants

can present and discuss the newest developments and breakthroughs in the field of pharmacy. It will set base for more interaction between pharmacy students and young graduates; May 11-12, 2013 Cyberjaya University College of Medical Sciences, Selangor, Malaysia. For details contact: Faculty of Pharmacy, Cyberjaya University College of Medical Sciences Email: Website:

18th Edition of FCE Pharma FCE Pharma will be held to promote pharmaceutical industry. At the event, exhibitors will get an opportunity to showcase their innovative products and services such as equipment, services, logistic, processes, quality control, outsourcing, analysis, laboratorial, process equipment, valves, automation and technology. The main aim of FCE Pharma will be to bring together world renowned companies related to raw material and packing. The event will provide the visitors with the latest developments and trends. The event attracts visitors and exhibitors from all over the world; May 14 – 16 2013, Transamerica Expo Center, Sao Paulo, Brazil. For details contact: NßrnbergMesse Brasil Tel: +55 (11)-3205-5000 Fax: +55 (11)-3205-5070

Email: Website:

International Congress of Toxicology 2013 The theme for the conference is ‘From Basic Science to Clinical and Environmental Outcomes’. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist of keynote/distinguished lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422 Fax: +82-2-566-6084 Email: Website:

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11, 2013, Korea

For details contact: Terrapinn Pvt Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Website:

3rd International Conference on Environmental, Biomedical and Biotechnology 3rd International Conference on Environmental, Biomedical and Biotechnology 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: Asia-Pacific Chemical, Biological & Environmental Engineering Society Tel: +86-28-86528465 (China Branch) Email: Website: The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.


Book Review Selection, Preparation and Pharmacological Evaluation of Plant Material The process of isolating therapeutically active plant extract is time consuming and commonly frustrating. This book tries to bridge the gap between the older methods of evaluating active ingredients and the newer techniques with respect to different therapeutic areas. Chapter one gives a brief description of roles of plants in traditional medicine, while chapter two explains the concept of dose response curve, which serves as a fundamental concept in presentation of results in active entity research. The next few chapters are dedicated to individual systems such as the GI system, liver, cardiovascular, respiratory, anti-inflammatory, diabetes, CNS and endocrine systems. Every systemic chapter briefly touches upon various methods of extraction and evaluation of therapeutic potential. Illustrations, graphs and charts try to explain technical processes in brief. It is a good book to get a brief idea of various old and new techniques in active principle analysis, but definitely not the final word.

Editors: Beatrice Gehrmann, Wolf – Gerald Koch, Claus O Tschirch, Helmut Brinkmann Price: ` 3,200

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

Medicinal Herbs: A Comendium Herbal formulations are widely being used in Europe and the Americas over the last few years. Herbal teas for minor ailments have started being used extensively by herbalists and pharmacists. This book is a simple ready reckoner compilation of 200 herbal plants, which lists each on their merits of area of application, dosage, applications, contraindications, adverse events, drug-drug interactions, and special comments if any. The language is simple, to the point and practical. The book serves as a bedside or clinic room guide to herbalists and natural herbal practitioners helping them in fine tuning their herbal concoctions. The book is not of great use to the industry at a large due to fairly limited chemistry described for each drug and also limited information on up scaling production being described. The book would have been much attractive with coloured illustrations of individual plants and active plant parts. If you want an instant summary of a given herb, either as a practitioner or herbalist or an enthusiast this is a good guide to have in your collection.

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


Editors: Elizabeth M Williamson, David T Okpako, Fred J Evans Price: ` 3,495

Publisher: Wiley & Sons 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:




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Pneumatic conveyor The MiniVac pneumatic conveyor comes with a complete integral blower, which eliminates the need for an expensive plant air or a separate compressor. The regenerative blower increases operating efďŹ ciency. It lengthens ďŹ lter life and maximises performance with a standard reverse pulse jet ďŹ lter cleaning system that keeps the ďŹ lter clean and at optimum operating efďŹ ciency. The standard size access doors allows for easy ďŹ lter replacement in less than ďŹ ve minutes without the use of any tool. The compact and integral blower eliminates the need for air piping and makes installation easier. Hapman Systems Pvt Ltd Vadodara – Gujarat Tel: 0265 – 2517505 Email: Website:

Corrosion-free cable management system Aeron FRP cable tray management system is developed for long lasting performance in challenging environments where corrosion & chemical resistance and

lasting mechanical performance are key requirements. Ladder type as well as perforated cable trays with wide range of sizes to select from is offered.

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Supremo Line & Control Ahmedabad – Gujarat Tel: 079 – 22205282, 22205181 Email: Website:

Chemical resistant diaphragm vacuum pump

Automatic labelling machine Automatic labelling machine is suitable for the application of the vignette label onto the main panel and of two self-adhesive tamper evident seals on the closure point of formed cartons. The machine is designed for carton Track & Trace by means of 2D datamatrix codes printing on line and subsequent veriďŹ cation with camera vision systems. It is an ergonomic balcony-design machine that offers full access to ensure cleaning and management comfort and guarantees a full view of the entire production process. The labelling machine works by steps, consequently guaranteeing high precision in label application and the ďŹ nished result. Size change over is precise, easy and quick.

Aeron Composite Pvt Ltd Ahmedabad – Gujarat Mob: 09909988266 Email: Website:

PTFE-lined valves

Fluoropolymer FEP, PFA, PTFE-lined SGI/WCB/SS pipes, valves and ďŹ ttings are manufactured using technical know-how and raw material for appropriate application of the resin. They have low co-efďŹ cient of friction, chemical inertness, excellent weathering resistance, zero water absorption, are non-toxic, non-inammable, selfsealant and approved by international food and drugs regulatory authorities.

Marchesini Group India Pvt Ltd Mumbai - Maharashtra Tel: 022 - 67082755/64

Chemical resistant diaphragm pump are the best suited oil free vacuum option for laboratory and pilot scaled application. Typical applications for chemical resistant diaphragm pumps include evacuating chemically aggressive gases and vapours from equipments such as rotary evaporators, vacuum drying cabinets and centrifugal concentrators. Most importantly, diaphragm pumps are oilfree, for vastly reduced service demands compared with oil-sealed pumps. They eliminate the water waste of water-jet aspirators, and the contaminated wasteoil disposal of rotary vane pumps. The diaphragms are available in various options of materials like EPDM, neoprene, viton and teon coated neoprene rubber. These vacuum pumps are available in the range of 15 lpm to 33 lpm and they generate a maximum vacuum of

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Trends 20 PSM Ind ia for medicpushes for unifo rm ines with tracing anregulatory stand ards d tracking system Radar level Cost-effectiv management e, reliabl e solutio for proces n s indust ry

Venus received approval Remedies has authorities from Austr alian thus enabl for four of its Partn ershi products ing the company facilities, p for (PSM) to expor India releas Safe Medi Australia. from these facilities t methodolo cines ed a revealed to The comp the India gy on February draft-based that India any has 10,00 Habit approval 15, 2013 receiv public comm at Centre, at produ0 manufacturers has more than Administrafrom Therapeuti ed GMP ents and New Delhi, for of pharm cts but among regulatory c Good tion (TGA aceutical wide Good Manu few qualify the all four of s ) Austr to its offici the stakeholdecirculation its facilit a sound practices, India standards facturing ies - cepha alia for carapenem track & must “The real of the rs, prior Pract innovative al launch. trace system adopt suppl challenge ices (GMP). This propo the and onco s, and oncol losporin, initiative a pilot acros is to chang ogy tax collecy chain. This sed manumind set will be to study Remedies logy lyophilised liquid of the will impro s launched tion from e produ factur the and not-o small said , cts and pharmaceut ve scale f-standards extent of spurio as understand ing units and Venus has in a statem Venus reduce and adopt standards make them ical us qualit that manu drastically meropenem already filed ent. policies medicines in India y factur not-ofmedic qualit the suppl or spurious medic dossie to , which ensure y in the bring good ines will fetch ing good of regist y chain safety and is on the r for ines from supply ration For the Governme . chain verge and than perpe return on invest profit and of facilit nt of patients first time in India. expedite y will furtheTGA appro ments rather tually can living of val process, the proce India should the law as a pilot, get their r exped under the in accre of effect it added ss of imple also ite the ive threat the unscr enforcers or in dited gover medicines . “We are ment laboratories made mand‘track & trace’ upulous the mercy nment-app tested Bejon planning systems ation market trader at of atory extrem Misra to s/reta alread roved support throu for expor for enter this ilers,� said , Founder, from PSM ely low cost local playe gh strategic ts and all products mean y The Speaking tie-up which India Initia with Work report of thePSM India. are under domestic produ t potential rs, where huge s with at the shop held Sheth Intern techn tive. meet, is price cts mark , VP, ology to ational P in India 2012 furthe single vial, forecast for et Internatio D be select control. The Pharmaceut in Septe vendor r emph ed mber neutral, irinotecan gemcitabine, docetaxel nal asised that said, “This ical Federation standards, based on should be topotecan, , imipe 2D bar Pawan will establ , on the Chaudharynem cilastatin,� and afford simple in implebest global ish trust quality Remedies able, espec , CMD mentation and existi regulatory Ltd , Venu ially for scale manu s In the Asia said. the manustandards betwe ng facturers. the small Pacific region is a lucrat Adequate en the consu factu rers ive reference need to and industry, market for pharm, Australia mers.� stand be PSM due to aceutical laboratorie made availa ards ageing India strong ble to population, its growing Initia tive new typess to keep up ly and to medic excellent formulation deman with of form access and India ded economy. ines and fast-r of ulatio standards global n regul ecovering should best atory offici ns be domestic for exported als the inspe invited as obser and drugs made Unichem ctions of vers in in the availa plan supply sites manufactur unit to s to sell by chain throuble a robus Mylan for ing drug t detection US FDA Euro pean India’s gh $ 30 millio Unio n, to prom Unichem technology Desiraju (4th regulatory and other ote n to sell Laboratorie (6th from from the left); C country identificatio universal produ a drug the agencies. Safety and left) inauguratingP Singh, Chairman, manufactur s plans located Efforts Drug Detectio NPPA th PSM India’s Drugs and n system under ct in harmonise shall be made n Technology’ International(5 from the left); US-based central India ing plant Cosmetics the India Mishra consu to worksh prevalent n codin to Act. mers to op on ‘Patient central 29.7 millioMylan for ` 1.6 a unit of state and g and a governmen spurious distinguishAnd enable billion n). unique to facilit ident and genui ($ t The deal ate comp regulations ne medic between mandification system universal produ Accor varie is ding execution ines. subject liance ct recall d to a PSM atory under shoul on ‘Patie on to the requirementrace abilit y nt existing India Repor between of a definitive the provi d become Technolog Safety and Drug Indian manner agree the two and sions of ts in t Act. Drugs regulatory drugmakers ment Detec There and Cosm the intero following open, a uniform Secretary, y’ by Kesh are perable av Desir tion relating and in a statem approvals, Unich Welfare Ministry of Healt to the samealso no provi etics providers aju, and em said ent. which sions h and Famil (MoHFW), and the for impo Service should play patien rted drugs y the it was also get Vivimed existing , consu a major role t groups shall further included mers drug recall law. To facilit in acquisitio Labs to into not-o f-stan about spuri educating ate s, globa Hyderabadn of Finoso Pharpropose l standards efficient ous and dard with quali ty and best Ltd has -based Vivim ma activ e drug s Governmen proposed ed supp ort based t of India. to acqui Labs Finoso from re cityPharma pharmaceuti Pvt company. cal developmen Ltd, a Nigeria’s for a total The acquisition t services will and Drug National Agen with cash, consideration of be done cy for Food (NAF DACAdministration ` 15 crore up comp and will stock and deferr and Contr ed be liance with to Pharm ) grant ed ol regul company’s debt free, accordpayment, perm ission aSecure NAFDAC’s ation starting ing to a for authenticats and exten After acqui statement. new consumers Nigeria. operations in ion capab d life-saving Vivimed’s sition, Finoso PharmaSecu the same we will becom which has of Niger ilities to millio re, innovators, R&D unit prote ns Indiacurrently provi ian consu been in to suppo e since India mers. de millio ction generics n consu After a 2009, efforts. rt and ns of recent will now be able With In addit mers.� Nigeria, trip to facility a state- licensing Nathan the first ion, Pharm in its high to implement of-th Co-Found Sigworth, aSecure in Hyde Alexandria Techn e-art volume based in and only such rabad, Finos cost-e is PharmaSecuer and CEO o Park and ffecti a revenue India that o had service authenticat ve SMS text been deepl re, said, “I have, manufactu enabl and ` 1.6 and EBITDA of recorded y impre Director rers to achie es Indian ` 5.2 crore Nigeria, ion services in crore NAFD ssed , last finan respectivel AC’s Gene Afric by track ve pharmaceut a’s larges cial year. to prote commitmen y, in the -and-trace ral of Foreign their t Trade PharmaSecu ical market. from fake ct consu merst comply fully mandate as well Sigwo re’s medi with Niger regulation will help services as rth my team cine, and s perta ia’s new industry authe ining bring our is proud dramatical to doing ntica tion requi to SMS text ly scale technology experience reme nts. so, We look and to the the forefr PharmaSecure forward In effort remains to offeri ont of ng Niger . reputation prote at ian of as a world cting India high qualit -class produ ’s y, afford able medic cer ines.

PharmaSe authenticcure to offer SM ation servi S tex ce in Niget drug ria



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30Torr. Chemical resistant vacuum pumps are also supplied with 3phase flame-proof motors. Sri Vishnu Pumps Mfg Co Thane - Maharashtra Tel: 022 - 28458372 Fax: 022 - 28457073 Email: Website:

Dynamic light scattering system Zetasizer Nano ZSP dynamic light scattering system is useful for highly sensitive measurement of the zeta potential, or electrophoretic mobility of proteins. The instrument delivers unique performance specifications for both size and zeta potential measurement, employing an approach to zeta potential measurement that accords with the latest industry guidance. It uses the company’s patented Diffusion Barrier Technique which protects the sample by isolating it from the electrode. Consequently the applied voltage can be switched on for longer periods to generate more reliable

Malvern Aimil Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 39183596 Fax: 022 - 39183562 Mob: 09867368075 Email: Website:

Symmetrical gravimetric analyser The model SGA100 symmetrical gravimetric analyser is a continuous gas flow adsorption instrument specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version) and 250°C (high temperature version), at an ambient pressure. This gravimetric analyser is available in a size of 18”width x 30” height x 20”diameter with a weight of 125 lbs. The symmetrical gravimetric analyser finds applications in pharmaceuticals, chemicals, drugs, food products, paper, fibres, powders, carbon, catalyst, etc. Smart Instruments Company Thane - Maharashtra Tel: 0251-2801123,Mob: 09323509969 Email: Website:

Flexible screw conveyor measurement data. The method involves the use of a unique, disposable folded capillary cell which allows measurements to be conducted on samples as small as 20 microlitre.

The helix flexible screw conveyor has only one moving part. The conveyor can be disassembled in less than 20 minutes for cleaning and maintenance. It can achieve lengths of up to 80 ft long. A

wide range of auger styles and sizes ranging from 2 to 8 inches in diameter is offered. The product meets stringent standards and has USDA certifications. It is one of the most economical conveyors and can be used in many applications. Hapman Systems Pvt Ltd Vadodara – Gujarat Tel: 0265 – 2517505 Email:, Website:


and high contrast provides superior resolution and excellent readability in poor light conditions or bad viewing angles. Temperature compensation circuitry and multi-temperature calibration provides outstanding accuracy over a temperature range of 0 to 50° C. Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 022-67162209 / 2222 Fax: 022-67162211 Email: Website:

Pallet shrinking tool Digital test gauge The digital test gauge Accu-Cal Plus is ideal for pressure measurement and for calibrating pressure transmitters, switches and gauges. Accu-Cal Plus digital test gauge offers outstanding accuracy, resolution and stability for pressure measurement and calibration requirements. It is used extensively in process monitoring and control industry. It is housed in waterproof casing of polished stainless steel and rated IP65/NEMA4. Accurate stainless steel pressure sensors offer models to cover from vacuum up to 10,000 psig with accuracy up to 0.05% of full scale. It provides numerous userconfigurable features including adjustable sample rates, dampening, tare, custom engineering units, minimum/maximum and password-protected field calibration. A five digit rotating backlit display with oversized digits, 20 segment bar graph

The pallet shrinking tool is used for shrink wrapping. Shrink wrapping of export pallets, giant pallets, giant articles, big articles/machinery are used to avoid damage during transportation. Boxes on pallets and other products can be shrink-packed within minutes. It provides five-sided protection for any size or shape load from small uneven pallets to large machinery and more strength than stretch wrapping. The tool is compact, portable and handy weighing 950 g. Dharmesh Enterprises Mumbai - Maharashtra Tel: 022-55233591 Email: Website: 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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Acoustic enclosure........................................... 21,27

Digital differential pressure transmitters and

Laboratory glassware.............................................. 23

Softening unit........................................................BIC

Activated carbon filter..........................................BIC

indicator................................................................... 28

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

Spectrophotometer ................................................. 28

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

Digital GPS clock.................................................... 28

Large diameter welded pipe .................................. 28

Stainless steel pipe .................................................. 28

Amino acid analyser............................................... 30

Digital magnehelic gauge ...................................... 28

Laser particle size analyser..................................... 30

Symmetrical gravimetric analyser ........................ 27

Analytical instrument ............................................ 23

Digital test gauge .................................................... 27

Liquid handling product .................................. 23,28

Synchronised digital clock ..................................... 28

Atlantis ..................................................................... 28

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

Measurement and analytical product ................. 3

Temperature and differential pressure indicator28

Atomic absorption spectrophotometer ............... 30

Dry van pump ................................................... 21,27

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

Tube.......................................................................... 28

Automatic labelling machine ................................ 26

Dynamic light scattering system........................... 27

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

Turnkey solutions for biotech and pharma industry .....BC

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

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

Motor ......................................................................... 6

U’ tube.................................................................... 28

Chemical resistant diaphragm vacuum pump 26

Electro de-ionisation..........................................BIC

Pallet shrinking tool ............................................ 27

Ultra filteration system ........................................BIC

Chromatography instrument ................................ 28

Exhibiiton - Plastivision 2013 ................................. 8

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

Vacuum booster pump ................................... 21,27

Clean room clock ................................................... 28

Final control element................................................

Pneumatic conveyor ............................................... 26

Vacuum system .................................................. 21,27

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

Final control system ....................................................

Pressure sand filter ...............................................BIC

Valve ........................................................................... 3

Clean room monitor .............................................. 28

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

Production HPCL................................................... 30

Water analysis instrument .................................. 28

Compressor ............................................................... 6

Flameproof clock .................................................... 28

PTFE-lined valve..................................................... 26

Waters sunfire ......................................................... 28

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

Flexible screw conveyor ......................................... 27


Welded pipe............................................................. 28

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

Gas chromatograph ............................................. 30

Regulator ................................................................. 3

Wireless clock .......................................................... 28

Controller and software ........................................... 3

Humidity ............................................................... 28

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

X Select HPLC Column ....................................... 28

Corrosion-free cable management system .......... 26

Humidity and temperature transmitter .............. 28

Reverse osmosis unit ............................................BIC

X’Bidge ..................................................................... 28

Data logger ............................................................ 28

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

Roots blower ...................................................... 21,27

Zero liquid discharge effluent treatment .......... 11

Demineralisation plant ........................................BIC

Laboratory equipment ........................................ 28

Seamless pipe ........................................................ 28

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Modern Pharma - 16-31 March 2013  

Modern Pharma is a leading fortnightly business magazine in India, catering to the pharmaceutical industry. Published by Network 18 Ltd., it...

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