Modern Pharma - 1-15 May 2013 by Infomedia18

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In Conversation With 12

Special Focus 16

Facility Visit 17

Event Report 25

Satish Varma Managing Director, Fermenta Biotech Ltd

Nutraceutical vs pharmaceutical industry: Is it a case of complementing or competing against each other?

SCHOTT KAISHA Pvt Ltd, Jambusar, Gujarat Automation leading the pathway

iPHEX 2013

Suven Life Sciences gets four patents in China, Mexico and New Zealand Hyderabad-based Suven Life Sciences has recently received patents for four of its NCEs; 2 in China, 1 each in Mexico and New Zealand. “We are pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,” said Venkat Jasti, CEO, Suven Life Sciences. The NCEs patent earned by the companies can be used in treatment of neurodegenerative diseases such as Alzheimer’s, attention deficient hyperactivity disorder, Huntington’s, Parkinson and schizophrenia.

Jubilant Life Sciences receives Corporate Social Responsibility award Jubilant Life Sciences Ltd recently received the prestigious ‘NDTV Profit Business Leadership Award 2012’ in the category of ‘Corporate Social Responsibility’ in an award ceremony that was held on April 8, 2013 at New Delhi. Speaking on the development, Shyam S Bhartia, Chairman & Managing Director and Hari S Bhartia, Co-Chairman & Managing Director, said, “Our efforts are directed towards empowering communities; we believe that for sustainable social intervention, the people themselves would have to be the drivers. We focus on community development through intervention in primary education, basic healthcare service and livelihood generation programmes targetted on improving the employability of women and local youth.” The social initiatives of the Company are carried out under the aegis of Jubilant Bhartia Foundation (JBF).

BMS selects Quintiles as preferred central laboratory provider Quintiles has been chosen as a preferred provider by Bristol-Myers Squibb (BMS) to provide global support for its central lab work, biomarker testing and assay development for the next five years. “This agreement deepens the commitment our companies share to providing patients access to effective, safe and affordable treatments,” said Thomas Wollman, Senior VP, Quintiles Global Laboratories. “We look forward to working with BMS to bring personalised medicine into mainstream drug development.”

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InnoPack Pharma Confex to focus on innovation in packaging for compliance and safety The second edition of InnoPack Pharma will kick start from June 27-28, 2013, in Mumbai, India. It will gather over 150 packaging professionals and around 30 exhibitors to the confex, which is dedicated to pharmaceutical packaging and drug delivery systems One of a kind in the Indian healthcare industry, InnoPack India continues to differentiate itself through its high-quality audience and positioning on technological innovations in packaging and delivery systems for pharmaceutical products. For all the pharma packaging professionals, this edition will offer many new features in terms of conference topics, networking formats and an exhibition area. This year, as a new approach, conference will focus on innovation in pharma packaging for compliance and safety. The topic has been chosen as the guiding principle by the strategic advisory board comprising Gautam

Buddha, Senior Director, Packaging Development, Dr Reddy’s Laboratory; Santanu Chowdhury, Associate Director - Packaging Development, Ranbaxy; and Rajesh Mishra, General Manager - Packaging Development, Abbott, to reflect on the important role played by compliance in the development of drug delivery systems and pharmaceutical packaging in order to create innovative solutions improving patient compliance.

A panel of international experts including Tassilo Korab, Director, Healthcare Compliance Packaging Council Europe (HCPC Europe); Laura Bix, Associate Professor, School Of Packaging, Michigan State University; Robert Winter, Director Materials

Management, Pfizer; and David Dronneau, Innovation and Technology Head, R&D Clinical Supplies, Sanofi, among others will tackle different aspects in the development of innovative packaging solutions over the course of more than 20 presentations and a number of debates offering a complete round-up of the current situation and new trends with regard to patient safety and compliance packaging, innovation in packaging materials and drug delivery devices, packaging for differentiation and consumers’ perception in packaging, sustainable packaging solutions for drugs and advancements in cost-effective anticounterfeiting technologies. InnoPack Pharma Confex brings a series of innovative networking sessions, which will take place alongside the conference programme. These meetings will enable participants to discuss in detail and receive expert guidance on current issues.

State CDSCO seizes ten drugs from pharmacy stores in Karnataka The state CDCSO seized ten drugs from the pharmacy stores in Karnataka, due to sub-standard quality of these medicines. The department conducted the inspection drive from April 1 to April 15, 2013. The seized drugs consist of Vecosil, a dexamethasone sodium phosphate injection IP from a Maharashtra-based unit; Zerd, a combination of domperidone and pantoprazole from Nikvin Healthcare located in Baddi in Himachal; Ornidazole and Ofloxacin suspension from Haridwarbased Akums Drugs and Pharmaceuticals; another Haridwar-based company

Biomedix Pvt Ltd; Glibenclamide tablet IP 5 mg from Embiotic Laboratories located in Bengaluru; Ofloxacin tablet IP supplied by Baddi-based Yonix Biotech; metformin hydrochloride tablets IP 500 mg; Dalmix DX, amoxicillin-dicloxacillin based formulation by JS Pharmaceuticals Pvt Ltd based in Haridwar; diclofenac sodium injection from Matrin and Brown Biosciences, based in Himachal Pradesh; Hyderabad-based Akhere Pharmaceuticals’ prednisolone tablets; and paracetamol and ibuprofen tablets manufactured by Ankur Drugs and Pharmaceuticals Ltd

Speaking about the recent drive, Dr B R Jagashetty, Drugs Controller, Government of Karnataka, said, “These drives are conducted on regular basis by our inspectors, who make a surprise visit and takes drug samples from drug stores at random for testing at our certified laboratories.” The department of drugs control has also released advisory to all drug stores and hospital pharmacies apart from the doctors and general public about not selling, prescribing and consuming these drugs.

Pharmexcil to open warehouses overseas to boost small pharma ﬁrms In an attempt to boost export business of small and medium pharma firms, the Pharmaceuticals Export Promotion Council of India Dr Appaji (Pharmexcil) has announced its plans to set up warehouse facilities in Latin America, Africa and Europe. The move is likely to help the small and medium drug makers to store their products at the facility

and supply them to local distributors when needed. The warehouse facilities would be opened under the ‘Brand India Pharma’ campaign. Dr P V Appaji, Director General, Pharmexcil, said, “As a part of initiatives to encourage exports by small- and medium-sized pharma companies, we are setting up our first warehouse facility in Nigeria and looking to set up more such warehouses in Latin America and Europe.” The Nigerian warehouse facility would

be ready by two months and it would help the pharma companies introduce their branded products, and the international warehouse will provide 75 per cent, 50 per cent and 33 per cent subsidies for three years, respectively, to the user companies. Appaji further stated that “the domestic pharma industry is eyeing an export target of $ 25 billion by 2014-15.” Indian pharma export is currently at $ 13.4 billion and we expect it to reach $ 25 billion by 2014-15.

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CONTENTS In Conversation With

Satish Varma Managing Director, Fermenta Biotech Ltd

Special Focus Nutraceuticals Rising nutraceuticals market Key to emerging opportunities

Changing regulatory scenario in nutraceuticals Survival of the ﬁttest!

Interface V S Reddy Managing Director, British Biologicals

Roundtable Nutraceutical vs pharmaceutical industry Is it a case of complementing or competing against each other?

www.modernpharma.in

Facility Visit SCHOTT KAISHA Pvt Ltd, Jambusar, Gujarat Automation leading the pathway

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan SENIOR EDITOR Manas R Bastia

Insight & Outlook Automation Trends: Innovations in PAT and QbD Aiming for improved pharma manufacturing

ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan

Interface K V Venugopalan President, Waters India Pvt Ltd

EDITORIAL TEAM Parita Dholakia, Pallavi Mukhopadhyay, Anubhav Sharma, Rishab Kothari, Nikunj Sharma (Delhi), Hardik Ashar (Bengaluru)

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Event Report iPHEX 2013 One-stop shop for buyers and manufacturers

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Editorial

Technology-based innovation: Way to grow! s the global pharmaceutical market place gradually shifts towards generics, the driving forces may vary from country to country depending on its present development status. On one hand, emerging opportunities due to patent expiries along with government efforts to expand healthcare insurance as well as reduced healthcare expenses are likely to boost the generics cause in the developed countries; on the other, fundamental drivers such as affordability and availability will add traction to the growing footprint of generics in the developing markets of branded generics. As things stand today, the Indian pharmaceutical market ranks among the global top five by production volume and accounts for over 10 per cent of global drug production. Valued in excess of $ 22 billion, it provides employment to more than 340,000 Indians, and thereby stands tall as one of the nation’s biggest employers by any particular sector. However, when one considers the magnitude of both types of competition – internal (more than 20,000 pharmaceutical companies) and external (generic pharmaceutical developers from other emerging nations that offer cheap products and the increasing global threat of counterfeit drugs), then it is time for the Indian pharma industry to focus on some key strategic differentiators to succeed in the future. Against this background, a recent workshop conducted by senior delegates at the Cambridge Consultants assumes significance.

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

The workshop, enriched by an attendance of a cross-section of senior personnel from a variety of functions within leading Indian and multinational organisations, brainstormed on India becoming one of the world’s leading pharmaceutical countries by 2030. According to recent reports, India’s domestic pharmaceutical sector is projected to grow to $ 55 billion by 2020. Further, as a significant exporter of high-quality generic drugs, the country is likely to have its export figure double and touch $ 25 billion by the end of 2014. To achieve such major milestones, the findings of this workshop revealed that Indian pharma companies need to embrace innovation and adopt technology in order to stay competitive at both domestic and global levels. Rightly so, with significant growth opportunities emerging on the horizon, those Indian pharma companies that leverage technology-based innovations not only to differentiate their products but also to make them more competitive on a global level can make the greatest impact in the time to come. Although there will be several challenges of resource limitations, the innovators at the forefront will require relentless focus on streamlining operations, rationalising costs and delivering value-added products profitably enough.

Manas R Bastia manas@network18publishing.com

Guest Editorial

Current scenario of quality compliances in pharma manufacturing (CROs) and its impact on the pharma industry’s growth he International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use) known as ‘ICH’ has developed different pharmaceutical guidelines: ICH Q10 model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, GMP and complements ICH ‘Q8 Pharmaceutical Development’ and ICH ‘Q9 Quality Risk Management.’ The final drafts have been recommended for adoption in regulatory bodies for European union, Japan and US. India as the 3th biggest manufacturer of pharmaceutical products and 14th in terms of value has not been considered in this list. Due to this the the Western world looks at India as a country that can only produce generic products. The Indian Government supports this idea mainly to keep medicines affordable for the general public and does not consider the benefits of having (the best) educated pharmaceutical engineers, professional setup, manpower, financial strength to invest and vision many pharmaceutical companies have. Maybe it is the fear of the ‘Western World’ (France has shown his fear for the fast growing Indian pharmaceutical market in the past) for India that

withhold the possibilities of top research units in India. To ensure a faster grow India has to change its image towards the world. India needs to be included in the ICH guidelines as a valued country, adapt these guidelines (if not implemented already). Expect the same from your suppliers, to many companies consider price before Company setup (system infrastructure, SOPs, QA/QC. Price will always be a concern but it can’t be the only criteria. Job workers and suppliers of raw materials, packaging materials, should be audited by third parties and evaluated as per the GMP and ISO guidelines to ensure that not only documentation is correct, also the SOPs are followed as expected, tests are really performed and not just documented. Labour laws are followed correctly. Audit occurs every year with 1 -2 surprise visits during winter and summer and give the chance to your customers to do the same. Suppliers who are taking their business serious will adapt to this work mentality, others will fail. Government needs to provide support and benefits for Clinical Research Organisations to stimulate new investments and developments that can benefit in the countries growth (financial, labour and medical).

It is only a matter of time before India will adapt, grow and meet the expectations of the Western World, the question is only how fast. Are we willing to grow faster? Are we willing to take the challenge? Are we smart enough to do this and do we have the willpower to setup and maintain these standards? Will the government give the necessary support? These are questions that each pharmaceutical company and the Indian Government has to ask itself? Vandenbussche Karl Director, Reynders Label Printing India Pvt Ltd

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News, Views & Analysis

Lupin expects sales to grow by around 25 per cent in next three years Drug maker Lupin expects its sales to continue growing at around 25 per cent globally for the next three years with contributions coming from all the markets where it is present. Lupin, which already has 11 approvals in the oral contraceptive space in the US, recently received a favourable ruling form a US court paving the way for it to introduce a generic version of Bayer AG’s Yaz tablets in the American market. The company will continue to add new therapies to its portfolio, bolster it with new drugs, in-licensing agreements and strategic alliances with like like-minded peers without specifying details. “If the past is prescriptive of the future, then we should continue to grow at the current growth levels and clock in a minimum growth of 22-25 per cent on all counts globally for the next three years,” said S Ramesh, President - Finance & Planning, and CFO, Lupin. Commenting on the markets that would drive growth, he said, “The good thing about Lupin is that in fact, our growth has been secular. It has not been restricted to America or India;, it has been across various markets.”

Ramesh

Speaking on the US market, Ramesh said, “Lupin is looking to sustain growth levels of up to 25 per cent in the current fiscal. We believe that going forward, one could look at us sustaining growth levels in the US at the current levels, a minimum growth of 23 to 25 per cent at the current levels for FY 2014.” The company had posted net sales of ` 2,530.3 crore for the 2011-12 fiscal in the US market. Lupin’s India business is likely to grow by 20 per cent in the next three years. “Our growth rate for the next two to three years should be between 18-20 per cent. So, it is business as usual in India,” he added. Lupin’s India region sales stood at ` 1,905.9 crore in 2011-12.

GE Healthcare Life Sciences and Sigma-Aldrich inks distribution partnership GE Healthcare recently announced the signing of a new agreement with SigmaAldrich to distribute its Whatman™ range of products in India. The Whatman range of innovative papers and filters includes sample collection and storage cards, filter papers, and specialist diagnostic membranes used in a wide range of applications such as forensics, neonatal

screening, environmental screening, quality control of pharmaceuticals, food and beverage production and in the manufacture of in-vitro diagnostic tests. Anurag Gupta, MD, GE Healthcare Life Sciences, South Asia, said, “We are delighted to announce this distribution agreement with SigmaAldrich, which will allow GE Healthcare to bring its innovative Whatman products to a much wider

range of customers in a variety of academic and industry settings across India.” “Continuing to deliver on our mission of enabling science to improve the quality of life, we are excited about the partnership. It will enable customers to benefit from Sigma-Aldrich’s established standards of service and operational excellence within India,” said Raja Ram, MD, Sigma-Aldrich, India.

USP unveils new logo and tagline The U S Pharmacopeial Convention (USP) launched a new logo and tagline to convey its key role in helping to ensure the drug and food quality worldwide. The new look is a visual expression of the principles embodied in the USP’s strategic plan that articulates a truly global vision supported by organisational initiatives and beliefs. In the line of its commitment to strengthen and expand the organisation’s core compendial mission, USP will also continue building allied compendial programmes and exploring emerging health needs. The new logo and the

strategic plan both grow out of USP’s fundamental

strengths: global expertise and trusted standards that improve health. Roger L Williams, MD, CEO, USP, said, “USP’s transformation since its founding by 11 physicians in 1820 has truly been remarkable. As an organisation, we remain deeply rooted in our practitioner history while keeping pace with dramatic changes in the science, technology, industry, human needs and global regulatory

environment for medicines, foods and supplements. Because USP is a private, independent organisation, it is well positioned to convene stakeholders representing diverse areas of expertise and national backgrounds, all with the goal of advancing health around the world. USP’s strategic plan and the new logo and tagline both represent this. It is something our many volunteer experts, convention members, staff and other stakeholders can be proud of. And -- most importantly -- providers, patients and consumers all benefit from USP’s ongoing commitment to good quality medicines

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News, Views & Analysis

Eli Lilly releases positive results of phase III study of dulaglutide in type 2 diabetes Eli Lilly and Company recently released positive results of two additional phase III AWARD studies of dulaglutide, an investigational, long-acting GLP-1 receptor agonist that is being investigated as once in week treatment for type 2

diabetes. The data reflects the efficacy of dulaglutide over insulin glargine. E n r i qu e C ont e r n o, President - Lilly Diabetes, said, “Dulaglutide, if approved, further advances our efforts to offer a broad portfolio of

therapies for people with diabetes, many of whom have unique needs. The results of our phase III dulaglutide trials are encouraging and we look forward to sharing more details on the AWARD studies at upcoming scientific meetings.”

Pﬁzer’s investigational compound receives breakthrough therapy designation for potential treatment of patients with breast cancer in USA Breast cancer is the most commonly diagnosed cancer in women and the leading cause of cancer death among women worldwide. In its quest to fight against this deadly disease, Pfizer announced the receipt of breakthrough therapy designation for its investigational compound palbociclib (PD0332991), an oral and selective inhibitor of cyclin dependent kinases 4 and 6 by the US FDA for the treatment of patients with breast cancer. Enacted as part of the 2012 US FDA Safety and Innovation Act, breakthrough therapy designation is intended to expedite the development and review of a potential new medicine if it is ‘intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate

substantial improvement over existing therapies on one or more clinically significant endpoints.’ The breakthrough therapy designation was based on preliminary phase 2 data in post-menopausal patients with ER+, HER2- locally advanced or metastatic breast cancer patient population. Data showed that women treated with the combination of palbociclib plus letrozole achieved a statistically significant improvement in median progression free survival compared to women who received letrozole alone (26.1 months and 7.5 months, respectively). The breakthrough therapy designation is distinct

from the US FDA’s other mechanisms to expedite drug development and review. “We appreciate the opportunity that breakthrough therapy designation provides to work closely with the US FDA on the development of palbociclib,” said Dr Mace Rothenberg, Senior VP, Clinical Development and Medical Affairs, Pfizer Oncology. “Palbociclib is one example of Pfizer’s commitment to identifying and translating innovative science into meaningful new treatment options for cancer patients.” Pfizer has initiated a randomised, multi-centre, double-blind phase 3 study (known as Study 1008) evaluating palbociclib in combination with letrozole versus letrozole alone as a first-line treatment for postmenopausal patients with ER+, HER2- locally advanced or metastatic breast cancer, which is currently open and enrolling.

In Brief Cadila Healthcare to merge some subsidiaries with itself Drug maker Cadila Healthcare has approved the merger of various wholly-owned subsidiaries, including Zydus Animal Health Ltd with itself. The board of directors of Zydus Animal Health Ltd (ZAHL), Live Healthcare Ltd (LHL) and Zydus Pharmaceuticals Ltd (ZPL) at their respective meetings approved amalgamation with Cadila Healthcare Ltd.The board of Cadila Healthcare also approved the amalgamation with ZAHL, LHL and ZPL, it added. Headquartered in Ahmedabad, Zydus Cadila Group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. The group’s operations range from API to formulations, animal health products and cosmeceuticals.

Quintiles bags best CRO award at World Vaccine Congress 2013 Quintiles has been named Best Clinical Research Organisation (CRO) in the Vaccine Industry Excellence Awards for the second consecutive year. Presented at the World Vaccine Congress now under way in Washington, DC, the awards recognise and celebrate individuals, organisations and initiatives which have made significant contributions over the past one year. The Best CRO award is presented to the honoured CRO following two rounds of evaluation. “We are proud to be recognised by our customers and peers as the best CRO,” said Dr Christopher Cabell, Senior VP, Therapeutic Delivery Unit, Quintiles. “We work every day to advance the development of quality vaccines and anti-infective products. This achievement celebrates our commitment to create a healthier world.” Quintiles helped develop, commercialise 73 per cent (11 of 15) of 2011’s best selling vaccine products and compounds.

Ranbaxy to expand operations in Brazil Drug maker Ranbaxy Laboratories and its Japanese parent Daiichi Sankyo recently announced synergies in Brazil to expand their business in the Latin American nation. As part of the collaboration, Ranbaxy will support Daiichi Sankyo’s Brazilian subsidiary, Daiichi Sankyo Brasil Farmaceutica Ltda to enter the branded generics market.

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News, Views & Analysis

Abbott launches ACCELERATOR® a3600, an advanced laboratory automation solution Abbott recently launched the ACCELERATOR® a3600, an advanced laboratory automation solution, to address the need to process tests faster while handling increased volume. Advances in technology and automation within the lab have led to more timely results leading to improved patient care. Automation systems include the various instruments, devices and software algorithms used in laboratories. Explaining about the new product, Brian Blaser, Executive VP, Diagnostics Products, Abbott, said, “As laboratories around the world face challenges due to staffing shortages, budget constraints and increased demands, advances in automation technology such as Abbott’s ACCELERATOR® a3600 can help labs be more efficient and productive. Labs using automation can achieve more than 40 per cent greater efficiency, helping them adapt to meet current and future demand,

which is particularly important as approximately 70 per cent of medical decisions are informed by diagnostic testing.” The new automation solution, developed with Abbott partner Swissbased Inpeco SA, is available worldwide pending country registration. It will help to learn more about the role diagnostics can play in increasing quality and efficiency in labs. The ACCELERATOR® a3600 is a laboratory automation track system that can process up to 3,600 samples per hour and handle multiple tube sizes and types simultaneously. By automating routine, manual tasks, this system may help labs reduce error and improve efficiency. Another advantage of the system is a modular design that offers labs the ability to install up to 99 combined analysers and modules on a single system, which means that labs can address their testing needs today while planning for the future.

India must become a leader in production of low-cost vaccines by 2020: Kalam India must become the leader of low-cost vaccines for HIV, cancer and malaria, and further target producing 20 per cent of world generics drugs by 2020, A P J Kalam. Former President, recently stated. Kalam stated, “India is rich in biodiversity which could be of immense use in the field of drug evolution and the pharma industry and pharmacists should do exhaustive research and evolve drugs based on traditional Indian plants and herbs to combat many of the prevalent diseases around the world.’’

The President further added that with the research being the foundation of academic excellence, there is a need to apply advanced methods and techniques to make the country leader in real terms. Science, technology and environment will have to go together for the development of new age science of nano-technology having tremendous application potential in medicine, electronics and material science.

CDRI develops new drug candidate to cure osteoporosis Central Drugs Research Institute (CDRI) came with a new formulation to cure osteoporosis and planning to begin the phase I clinical study for the new drug candidate. The institute will form partnership

to license S007-1500, a quick healing candidate for fracture. CDRI has also made considerable advancement in developing other drug candidates to treat diabetes, malaria, thrombosis and osteoporosis.

Cognex Corporation announces new version of In-Sight® Track & Trace

Cognex Corporation announced a new version of the In-Sight® Track & Trace identification and data verification solution for healthcare serialisation. A sequel to successful deployments of In-Sight Track & Trace 1.0, this version includes enhancements that address additional requirements for pharmaceutical and medical device manufacturers to achieve unit-level product traceability. Customers can use In-Sight Track & Trace 2.0 with multiple networked In-Sight vision systems to decode human-readable text along with 2-D and 1-D barcodes, including Data Matrix, GS1-128, GS1 DataBar, securPharm and Pharmacode. “In-Sight Track & Trace is an off-the-shelf label verification and serialisation software supplement for our pharmaceutical customers required to comply with GS1 and FDA regulations and similar laws worldwide,” says Herbert Lade, Vice President and Business Unit Manager, Vision Systems. He adds, “In the newest version, we incorporated bundling reading support, secondary authentication capability and our OCRMax™ tool for the highest read rates in the industry. This new feature provides superior read rates of human-readable dates, lot codes and serial numbers.” In-Sight Track & Trace can be easily integrated into third-party serialisation software or MES with industrial protocol support and built-in I/O controls. The technical controls needed for FDA 21 CFR Part 11 validation, including secure user authentication and automatic audit trail generation, are also included.

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News, Views & Analysis

Sabinsa wins Frost & Sullivan award for unique technology The New Jersey-based Sabinsa Corporation of pharmacistscientist Dr Muhammed Majeed bagged the Frost & Sullivan’s 2013 North American Integrated Prebiotic Delivery Technology Innovation Award. The honour comes in recognition of the company’s Integrated Nutritional Composites™ (INC) technology that allows it to create a combination of prebiotics and probiotics. The bi-layer ‘synbiotics’ technology delivers stable Dr Majeed and active formulation of ingredients which may otherwise be incompatible or difficult to co-formulate, thus assuring effective working, according to Bengaluru-based Sami Labs Ltd, which owns the 1988-founded Sabinsa. The benefit of the technology has already begun reaching its consumers in India through Sami Direct, the

2010-established marketing arm of the parent company. “The bi-layer tablets enable the integration of incompatible ingredients and help explore different time-release profiles of the ingredients. They are also quite attractive due to their two-tone appearance,” said Arpita Mukherjee, Research Analyst with the California-located firm that provides customerdependent market research and analysis besides growth strategy consulting and corporate training services. Sabinsa said the award validated the innovation that has always driven the company. “We are certainly honoured by this recognition,” stated Dr Majeed, who migrated from his native Kerala to the US in 1975 to do his MS in Industrial Pharmacy from Long Island University and later a doctorate in the same field from St John’s University, also in New York.

US FDA gives ANDA approval to Indoco’s glimepiride Mumbai-based Indoco Remedies Ltd received the US FDA approval for its Abbreviated New Drug Application (ANDA) for glimepiride 1 mg, 2 mg & 4 mg tablets. The drug is indicated for type-2 diabetes mellitus treatment as an added therapy with diet and exercise to improve glycemic control in adults. The market size of this product in the US is $ 90 million and the API consumption is approx 2,000 Kgs growing at 11.2 per cent. “This is the first ANDA approval for solid dosages for Indoco and the Company is fully integrated to manufacture this product. The product will be launched in the US in the month of May 2013,” said Aditi Kare Panandikar, MD, Indoco Remedies Ltd.

Novartis partners with an NGO to end malarial deaths in Africa by 2015 Swiss multinational pharmaceutical company Novartis and Malaria No More, a leading global charity determined to end malaria deaths, recently announced that they are joining forces on the Power of One campaign to help close the treatment gap and accelerate progress in the fight against malaria. As per the coalitiion, over the next three years, Novartis will support the campaign financially and also donate up to three million full courses of its paediatric antimalarial drug to match the treatments donated by the public, doubling the impact of these donations. “Malaria is a complex issue and needs a multi-pronged collaborative approach. We cannot solve a problem like this on our own,” said Linus Igwemezie, Head, Novartis Malaria Initiative. “Through partnerships, with organisations such as Malaria No More, we can speed up progress toward the ultimate goal of malaria elimination,” she added.

Eli Lilly buys two PET tracers to accelerate Alzheimer’s R&D Eli Lilly and Company recently purchased two investigational PET tracers from Siemens Medical Solutions USA, Inc. Subsequent to the investment, the company will strengthen its long-term commitment to develop novel medicines for Alzheimer’s patients. Justifying the acquisition, Jan M Lundberg, PhD, Executive VP, Science and Technology, and President, Lilly Research Laboratories, said, “The acquisition of these tau tangle tracers builds on our 25-year commitment of investing in Alzheimer’s disease research and development to bring new medicines to patients facing the terrible consequences of Alzheimer’s disease. We are hopeful that this technology will both enhance our understanding of tau and its role in Alzheimer’s disease, and contribute to the development of our anti-amyloid and anti-tau based therapies to treat this disease.” James Williams, CEO, Siemens Molecular Imaging Business Unit, said, “PET imaging is a valuable

tool in the fight against Alzheimer’s disease, and Siemens is committed to helping fight this growing threat to our aging population. Lilly’s continued development of these tau PET tracers combined with Siemens’ ongoing investment in innovative PET imaging solutions is another great example of how Siemens is collaborating with pharmaceutical companies in an effort to provide new hope to patients and their families.” Initially, the company will focus on incorporating this new technology into its anti-amyloid and anti-tau R&D programmes. Use of a tau tangle tracer could enable tailoring and early identification of at-risk patients, as well as potentially provide a marker for treatment response. Lilly also has the option to commercialise the tracers. The tracers will be developed and validated by a team at Avid Radiopharmaceuticals, Lilly’s wholly owned subsidiary focussed on molecular imaging. Financial terms of the deal are not being disclosed.

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News, Views & Analysis

ISO 9001: 2008 certiﬁcate for Gandhi Automations Gandhi Automations Pvt Ltd is the only Indian company in entrance automations to receive the ISO 9001:2008 certification in accordance with TUV NORD CERT procedures. The company chose the respective certification body keeping in mind the reliable auditing procedures that the body practices. It is a matter of pride for India’s No 1 entrance automations and loading bay equipment company to be receiving this certificate from the reputable body. The certification is applicable to manufacturing, installing and servicing of gates, doors & rolling shutters, dock levelers, dock shelters, boom barriers, rolling shutters, fire shutters, doors and gates and access control systems. It was in 1996-97, when Samir Gandhi and Kartik Gandhi, Company Directors, established ‘Gandhi Automations’ in India. Today, the company has direct presence in 23 cities of the country employing dedicated personnel. Gandhi Automations dream big and its personnel actualise those dreams through sheer hard work and dedication. Known for its superior products and extraordinary after sales service, Gandhi

Samir Gandhi

Automations is growing in leaps and bounds by each passing year. The Company has added one more feather on its cap by acquiring a 100,000 square feet of land at Bhiwandi where the work of factory building is in process. Growth is the only thing that is consistent in the company. Gandhi Automations will now adhere to ISO standards, thereby ensuring its clients about the safety and reliability of the products and services offered to them. No other company in the entrance automation sector complies with such high safety standards. Gandhi Automations has always believed in improving the efficiency in its operations, and therefore, implementing the ISO standards was the right step in that direction.

Orchid partners with Allecra Therapeutics to develop novel antibiotics Chennai-based global pharma major, Orchid Pharma, has recently entered into a strategic partnership with Europe-based venture capital funded Allecra Therapeutics for development of novel antibiotics to combat multidrug resistant bacterial infections. As part of its investment into Allecra, Orchid has assigned to Allecra Intellectual Property (IP) related to an antibiotic discovery programme, which will then be pursued through further trials by Allecra. Under the terms of the agreement, together with shareholding, Orchid will also be paid an upfront sum and is eligible to receive further royalties and exit bonuses based on Allecra’s progress. Bacterial resistance to current antibiotics is widespread and growing

exponentially leading to increased urgency to combat what has been called the ‘epidemic of antibioticresistance.’ Allecra will aim to contribute to this cause by developing new treatments, which overcome emerging bacterial resistance mechanisms, thereby saving lives of patients whose infections may otherwise be inadequately treated. Commenting on this partnership, K Raghavendra Rao, Chairman & MD, Orchid Pharma, said, “We have always believed in building collaborative business models to achieving our vision. This strategic partnership with Allecra is yet another demonstration of how we can create value by harnessing the relative strengths of each company.”

Strides Arcolab pacts JV with Pfenex Pfenex Inc and Agila Biotech Private Ltd, a subsidiary of Strides Arcolab Ltd recently announced that they have entered into a joint venture to develop, manufacture and commercialise an initial pipeline of six biosimilar products for the global market.

Operating as a JV, wherein both parties will equally share in decision making regarding product development and commercialisation, Agila Biotech will be a 51 per cent equity stakeholder.

Sinovac obtains commercial approval for seasonal ﬂu vaccine in Mexico

Sinovac Biotech Ltd, a major supplier of vaccines in China, obtained Certificate of Approval to commercialise seasonal flu vaccine in Mexico by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of the Mexico Ministry of Health. In 2005, the company filed the application to distribute Anflu in Mexico, and received the GMP certificate for its seasonal flu and hepatitis A vaccines in 2011. Dr Weidong Yin, Chairman, President and CEO, Sinovac, said, “This is a great milestone for Sinovac as we look to continue expanding our commercial efforts worldwide. We are pleased to receive approval to supply Anflu in the Mexican market, which we perceive as a significant opportunity outside of China. We expect to begin sales planning for Mexican market in conjunction with our partner, Laboratorios Imperiales, in the coming days.” Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company operating in Mexico since 1935, is the exclusive distributor of Sinovac’s vaccine products in Mexico, pursuant to a distribution agreement signed in 2005 with its affiliate.

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News, Views & Analysis

QUA® launches FEDI®-2Rx fractional electrodeionisation for pharmaceutical, biomedical and laboratory applications QUA® has launched FEDI®-2Rx fractional electrodeionisation product range, specially designed for applications in pharmaceutical, biomedical and laboratory applications where installations require hot water sanitisation to meet pharmacopoeia standards for Purified Water (PW) and Water For Injection (WFI). With patented dual voltage technology, QUA’s FEDI technology is the next generation of Electrodeionisation

(EDI) technology for the production of high purity water. Developed taking into account the limitations of conventional EDI, the FEDI process improves the reliability of EDI for the production of high purity water. “After successful acceptance of our industrial range of FEDI, we are now ready to service the pharma, medical, biomedical, cosmetics and laboratory arena with our innovative product range branded as FED-2 Rx. We are confident

that our patented process of manufacturing ion exchange media will provide improved

reliability of performance in these applications,” said V J Nathan, Technical Director, QUA Group. The QUA Group’s FEDI has more than 25 global installations including various sites inUSA, Europe andAsia. The company recently received the 2013 Frost & Sullivan New Product Innovation Award for industrial water & wastewater treatment technology, North America, for FEDI electrodeionisation and its Q-SEP® hollow fiber ultrafiltration modules.

Boehringer Ingelheim announces a strong 2012 performance in China Boehringer Ingelheim recently informed about its performance on the Chinese market in the business year 2012. With sales of 358 million Euro/2,904 mio RMB, which

marks a growth of 32 per cent in 2012, it will accelerate its strategic business development in China, a market of significant importance to the company.

Non-toxic StabilOx oxygen-absorbing canisters provide good drug stability Recently, an uncharacteristic odour associated with a competitor’s oxygen absorbing canister caused a voluntary drug recall by a major pharmaceutical manufacturer. Multisorb’s non-toxic StabilOx® oxygen-absorbing canisters were neither the cause nor were involved with this drug product recall. The substandard oxygen absorbers are a systemic issue in the industry. Though not the fault of the pharmaceutical manufacturers that closely adhere to regulatory requirements, recalls like this create a long-lasting, negative impact for the manufacturer as well as for the consumers, which rely on the drug product. For pharmaceutical manufacturers concerned about oxygen absorbers creating off odours and potentially contaminating their drug products, Multisorb Technologies continues to supply the pharmaceutical industry with its non-toxic StabilOx oxygen-absorbing canisters. These do not exhibit the unpleasant odour that initiated the recall. Multisorb’s StabilOx canisters offer a minimum 100cc of oxygen capacity and can be used with standard High-Density Polyethylene (HDPE) bottles. StabilOx canisters reduce oxidative degradation of drug products and stabilise the pharmaceutical formulations by managing the package headspace moisture and drug product free-moisture. When used within a foil-laminate heat induction sealed standard HDPE bottle, StabilOx canisters will effectively reduce oxygen to levels below 1per cent while maintaining humidity levels to <30 per cent, thereby preventing over-drying and balancing the drug product’s chemical and physical stability profiles. For added value, Multisorb’s StabilOx system combines the protection of its product with the reliability of its APA-9000 StabilOx canister dispenser, offering an unparalleled system for reliability and ease.

"We see significant potential in China as one of the major strategic markets for the company’s future growth," said Professor Andreas Barner, Chairman - Board

of Managing Directors, Boehringer Ingelheim. "We are committed to investing and to introducing more innovative medicines and animal health solutions in China."

IDMA to organise two days conference on Food Safety and Standards

Indian Drug Manufacturers’ Association (IDMA) will be organising two days conference on May 10-11, 2013 at Bandra-Kurla Complex, Mumbai, to discuss the Food Safety and Standards Authority of India (FSSAI) Act in depth. The Nut raceut ic a l Subcommittee will conduct workshop on ‘Product Registration Under FSSAI: Know-how & Challenges.” The conference will help nutraceuticals manufacturers, food businesses and nutrition professionals in the country.

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In Conversation With

Work upon feedbacks to excel in personal and professional lives …says Satish Varma, Manging Director, Fermenta Biotech Ltd. A visionary who switched to bio-based manufacturing during its early genesis in India took an unsual route with opening a biotech plant at an odd location and yet tasted success. Here, he discusses his journey, vision and future prospects of his brainchild, Fermenta Biotech Ltd.

Nikunj Sharma nikunj.kumar@network18publishing.com

From a small biotech set up to being the pioneer supplier of immobilised NPGA and Vitamin D3 manufacturer; how has FBL’s journey been so far? The journey so far has been in equal measures eventful, challenging and rewarding. From our starting point as the first Penicillin G Acylase (PGA) enzyme supplier in the Indian market, FBL has become, largely through its efforts on proprietary research, a diversified and multifaceted enterprise. We can claim to be among the few leading global enzyme suppliers that can cater to varied beta lactam applications as well as having enzymatic products for applications in the manufacturing of other pharmaceuticals and fine chemicals. Building on our heritage in the enzyme field, we are also developing an enzymatic platform to address the challenges of water treatment in a number of specialised areas including lakes, ponds, sewage and effluent treatment plants. In the field of enzymatic conversion, we are proud to be one of the companies leading from the front to power the switch over of the current chemical processes to efficient and effective green technologies. Finally, we are also an important player in the global market for Vitamin D3 API and produce a limited range of other speciality pharma-based APIs. Do you agree that the Indian pharma sector is apprehensive in switching to green manufacturing? I do not agree with that as we see increasing number of companies showing willingness to invest in the transformation from chemical processes to more eco-friendly biotech processes. Typically, the solutions one looks for should give benefits over the current technologies and this is becoming increasingly possible with the advanced technologies being developed and delivered in this field. Tell us about the research collaboration you have in India or

abroad to bring and develop the novel enzyme technology in the market. We have always looked forward for R&D collaboration to strengthen our product pipeline and portfolio. Indeed, our very first research collaboration was with the Czech Institute of Sciences way back in 1986, which continues to the present day. Apart from our own internal research we have also developed collaborations with a number of preeminent Indian Institutes such as IISc Bangalore, Anna University Chennai, NCL Pune and more. I must say that these collaborative efforts help us bring in expertise from different fields to deliver the desired results. What are the valuable APIs or formulations processes, which can be accessed through green/enzymatic routes, FBL is currently targeting? Currently, FBL’s proprietary PGAbased enzymes platform is aimed at, integrated, scalable and economic green manufacturing routes for some of the world’s most widely used antibiotics such as amoxicillin, ampicillin and cephalosporins like cephalexin, cefprozil, cefaclor, cefadroxil, to mention a few. In addition, our generic CALB lipase is targeted to be used in variety of applications ranging from chiral synthesis/chiral resolution in novel drugs, fine chemicals, to biodiesel, bio lubricants and biopolymer applications. CALB lipase is a versatile enzyme with a broader application spectrum. You are among the major producer of Vitamin D3 in India; how do you find the market prospects for this product in India as well as abroad? We see the usage of Vitamin D3 increasing rapidly in the near future. This is driven by a number of factors but principally underpinned by the growing consensus on its importance as a vital nutritional and clinical supplement. This profile is in turn built on the results of increasing number of studies linking Vitamin D3 deficiency to a broad range of ailments. In addition, many epidemiological studies indicate severe Vitamin D3 deficiency prevalent across major sections of the populations across

the globe. We feel there is much to be done in bridging this gap and responsible institutions worldwide, both private and public players, are taking several initiatives towards this objective. What are unique features of your immobilised NPGA enzyme catalyst that keeps you ahead in the market? Our proprietary immobilised NPGA is designed to be faster on synthesis, slower on hydrolysis, technically known as S/H ratio. As in most of the enzymatic synthesis process, the use of side chain ratio will be main driver for the process economics and NPGA offers advantage of using the lowest ratio possible. We have a large basket of immobilisation technologies and this helps us in offering a stable product for long term repeated use. You are getting an overwhelming response from overseas markets; do you believe that decade long seeding through sincere R&D and marketing efforts are now delivering fruitful results? Yes. Ultimately one needs to be able to deliver a cost-effective quality product and service. Focussing on sincere research efforts helps us to bring in continuous improvements in our manufacturing and product quality. Moreover, we put in a significant part of our research efforts into enzymes for new applications, which helps us expand our offerings to customers. Apart from the focus on pharmaceutical products, you are also foraying into environmental projects in different Indian states? Please share the response from government and private organisations. We have recently entered this segment and it is too early to comment in detail. We have started offering services and products in lake bio-remediation and bringing in significant efficiencies into the sewage and effluent treatment plants in terms of plant performance and energy conservation. We believe that there is much work to be done in this area in India and FBL would like to play a pivotal role in this field.

Tell us about any important learning from your life. Lessons have been plenty but their relevance can only be realised by bringing a positive change in your life. Accept criticism with an open mind and work upon feedbacks to excel in personal and professional lives. What is the source of your motivation? The results of earlier efforts and the belief that I play a part in the pioneering work continuously executed by FBL is a major source of motivation and inspiration for me. What is your success mantra? One individual cannot bring organisational success. It happens when you have faith in your colleagues, and I am equally blessed with their unconditional trust in me, which together has translated into the impressive growth that FBL have registered in the last six years. What rejuvenation activities you generally follow to beat the stress? I find that 20 to 30 minutes of yoga everyday helps a lot in balancing the daily work stress. During free hours I restrict myself within the boundary of my house to spend quality time with family or read some soothing content available around. Where do you see Fermenta in the near future? I see us evolving as an R&D-based pioneer in speciality and niche segments where we can bring differentiated products and services of value to the market. While I see FBL continuing to play an important role in the evolving Vitamin D3 market, both in bringing up the awareness and ensuring availability, I believe FBL will be one of the pioneering companies in the transformation of current chemical processes to biocatalytic processes. It would be personally satisfying for me if we are successful in playing a meaningful role in helping rejuvenate the condition of contaminated water bodies, oil dumps etc and ensuring that technologies are implemented to reduce or eliminate further pollution of our environment.

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Special Focus

Rising nutraceuticals market

Key to emerging opportunities Healthy civilians lay the foundation to prosperity of any nation. With the changing perception of health, nutrition is at the heart of this country. Present feature explores this scenario, provides insights into current trends and challenges in the upcoming nutraceuticals sector in India.

Hardik Ashar hardik.ashar@network18publishing.com

“Leave your drugs in the chemist’s pot if you can heal the patient with food,” the famous words of Hippocrates, the Father of Medicine, have come of age and seem true even in this 21st century. Food not only satisfies hunger and provides nutrition, but prevents some diseases and promotes physical-mental well being. The concept of food and medicine being complimentary to each other is not new. The term ‘nutraceuticals’ may seem new but it is based on our traditional knowledge, now backed by science. Having understood this fact, globally, companies are now disseminating products in the growing nutraceuticals space. “Nutraceuticals market keeps rising as people are becoming more conscious about their health and beauty,” suggests Dr Yutaka Ashida, Manager, Healthcare Business Division, Shiseido Co Ltd, Japan.

to industry consolidation, maturing markets in the developed countries, higher incomes owing to greater personal care and increased spendability amongst people of the developing markets, and increased interests in supplements to enhance the beauty,” avers Dr Ashida. Nutraceuticals are also emerging as new areas with products such as Conjugated Linoleic Acid (CLA) soy, whey and dietary fibers claiming to facilitate in weight management. Growth emanates from specific products developed for gender groups, kid groups and age-related treatment.

Rising opportunities in market According to the market report published by Transparency Market Research group in 2011, global nutraceuticals market was at $ 142.1 billion. Forecasts suggest this market to reach $ 204.8 billion by 2017, growing at a CAGR of 6.3 per cent through these years. “At present, North America is the biggest market followed by Asia Pacific,” informs Dr Muhammed Majeed, Founder and MD, Sami Labs Ltd, India. A study from FICCIFrost & Sullivan suggests that Indian nutraceuticals market was worth closer to $ 2 billion in 2010, with projected sales of $ 5 billion by the year 2015. “India continues to maintain a dominant position as one of the world’s key emerging economies and with rising health conscious population, nutraceuticals market will see higher growth in the near future,” he adds. “The market is growing successively,” agrees Dr Ashida. “Chief reason of such market growth includes increasing competition leading

In last few decades, nutraceuticals and functional foods are increasingly gaining popularity in the Asian market. Dr Yutaka Ashida Manager, Healthcare Business Division, Shiseido Co Ltd, Japan

Factors driving business The factors taking the business of nutraceuticals to new horizons are chiefly increased awareness, affordability and accessibility. “There has been significant increase to promote health and wellness through nutraceuticals consumption among the people as well as physicians. The rapidly increasing interdisciplinary scientific information about medicine and food acts as

a factor for speedy growth of nutraceuticals sector,” informs Dr Majeed. “The urbanisation of India, lifestyles becoming sedentary, adds to growth opportunity for many existing and new companies to enter this area,” he adds. “In last few decades, nutraceuticals and functional foods are increasingly gaining popularity in the Asian market,” says Dr Ashida. “Generally speaking, basic nutritional supplementation such as multivitamin, mineral supplement and analeptic including regional traditional medicine such as energy drink, herbals are catching popularity across Asia, for reasons such as affordability,” he adds. “FMCG channels provide alternate yet effective way of distribution of these products directly to the consumers. Now, such products are easily accessible by a larger population,” says Dr Majeed. Distributors have also seen an increase in sales of supplemental food as more consumers are now using digital channels to purchase products. According to research conducted by Euromonitor International, the global vitamin and supplement market is worth $ 68 billion with Internet sales contributing a major share in the growth of supplement demand. Among some other factors driving nutraceuticals sales is the increasing ageing population, who continue to struggle with increased health concerns for longer life spans. Because of an uncertain economy, coupled with increased consumer knowledge and awareness of organic methods to improving health, the demand for supplements stays on rise.

Current trends and challenges The nutraceutical industry has far exceeding potential when compared to expansion

in any other industry. Many new players are now entering this niche area leading to increased market competition. “Available data suggests that 55 per cent of food, 36 per cent of pharmaceuticals and

With rising health conscious population, nutraceuticals market will see higher growth in the near future. Dr Muhammed Majeed Founder and MD, Sami Labs Ltd

90 per cent of biotech firms are actively researching nutraceutical products,” says Dr Majeed. “Science has created a new interest and demand for ayurvedic and plant products,” affirms Dr Majeed. “Claims are now backed by research data,” agrees Dr Ashida. “Enzymes, probiotics, nutricosmetics and cosmeceuticals are some of the upcoming trends, which will see growth in the near future,” suggests Dr Ashida.

“However, the road is not as smooth as it seems. There are many challenges that need to be tackled. Issues related to quality control of these product needs to be addressed. Also, the legal system for nutraceuticals is quite different among countries. Some ingredient is legal in some countries, but illegal as food in others. The regulation of labelling is also quite different. The correct functional sign for proper usage is desirable for the benefit of consumers,” says Dr Ashida. “Current regulation is a mixed pot,” agrees Dr Majeed. The regulatory framework of nutraceuticals in India requires attention from the authorities. In India, the archaic laws are still governing the use of nutraceuticals. Sometimes, there is lack of clarity on classification of functional foods and nutraceuticals. “In addition, with increasing consumer concerns on food safety, the quality of the raw materials used to create nutraceuticals is under high scrutiny. Recalls due to safety concerns can breakdown even the most established companies, emphasising the importance of using quality ingredients that can be traced. On top of all this, unsubstantiated claims by many players create credibility problems also for this sector,” narrates Dr Majeed. “Future is bright as we move forward with science,” he adds.

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Special Focus and requirements should be met in order to make specific product claims.” Shetty adds, “These reforms and regulations are an extremely welcome change since they bring about in a large sense of clarity in the regulatory guidelines, the lack of which had given rise to various spurious products in the market, low in quality, unscientific claims and no safety data. To a large extent, it has created a level-playing field among manufacturers and marketers of nutraceuticals and is a giant step towards organising the nutraceutical industry in India.”

Changing regulatory scenario in nutraceuticals

Survival of the ﬁttest! Regulations guiding nutraceuticals are evolving in India. However, the establishment of the Food Safety and Standards Authority of India (FSSAI) under the Food Safety and Standards Act has been instrumental in streamlining operations and bringing all existing laws surrounding food and food technology under a single roof. While it has been successful in addressing many issues, some loopholes exist. The industry still expects more. This article takes a look at the current regulatory scenario of nutraceuticals in India.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

ver the recent years, interest in nutraceuticals is gaining momentum due to its presumed safety, nutritional value, chronic disease preventing properties and health benefits. India is witnessing a rise in the consumption of both traditional nutraceuticals such as herbals, phytochemicals and non-traditional nutraceuticals such as fortified or recombinant foods. Both domestic and multinational players are contesting for the emerging nutraceutical market. M&As and tie-ups of pharmaceutical and nutraceutical companies are on the rise. According to a report by Transparency Market Research, the global nutraceuticals market was estimated at $ 142.1 billion in 2011 and is likely to grow at a rate of 6.3 per cent to reach $ 204.8 billion by 2018. This growing trend is also indicative of the fact that public demand is fast evolving and this has propelled the need for strict regulatory norms guiding the nutraceutical industry to ensure quality, safety and efficacy of the end products and minimise long-term side effects.

Changing regulatory framework As the nutracuetical market is booming, regulatory authorities world over are concentrating on product quality and safety. Previously, both food and drugs were governed by a single body, the Food and Drug Administration (FDA). Also, multiple laws and regulations

were governing the food and food processing industry creating confusion. There was heightened need to integrate all existing laws and establish a single reference point for all matters related to food and safety standards. The Food Safety and Standards Act (FSSA) passed in 2006 by the Government of India was a huge step in this direction. The Act consolidates eight laws governing the food sector. Some of the new provisions in the Act include

The industry is waiting to see FSSAI build strength, regulate the market and streamline and accelerate the process of product approvals. Neeraja Shetty Director and President – Strategy and BD, Sami Labs Ltd

quality control of food imported into the country, undertaking risk assessmet, communication and management, improving co-operation with international organisations, providing training programmes, harmonising domestic and international food standards among others. However, the regulation and

the growth of nutraceutical industry in India were handicapped by the lack of dedicated regulation both for its manufacture and its claims. They were clubbed and mixed up with conventional foods leading to considerable confusion and a spurt of malpractices by manufacturers and marketing companies. Subsequently, in 2011, the Food Safety and Standard Regulations was enforced and Food Safety and Standards Authority of India (FSSAI) formally came into existence. They emerged with a detailed process of approval of nutraceuticals, health supplements, novel foods and ingredients, etc. Neeraja Shetty, Director and President – Strategy and BD, Sami Labs Ltd, says, “The aim of FSSA was to overcome the shortcomings of prior laws and regulations and most importantly address the lack of consolidation on the nutraceutical matter between different departments and ministries. This Act consolidated the laws related to food and established FSSAI that would play a role in laying down science-based standards for food items and regulate their manufacture, storage, distribution, sale and import.” The establishment of FSSAI has been instrumental to a certain extent in streamlining procedures and empowering the State Food Safety Authorities to monitor and regulate the food business operators. In order to adhere to the Indian regulatory requirements for nutraceutical products, important areas of focus have been listed by FSSAI for the industry players. The process details the steps involved in the approval process

Issues at hand

of nutraceutical ingredients and products before they are placed in the market. Dr Raja Smarta, MD, Interlink Marketing Consultancy Pvt Ltd, elaborates, “Procurement of the Food Business Operation licence is the first step for the business operator. For this, preparation of the product dossier and its due submission to FSSAI is essential. The product is then evaluated and analysed by a scientific panel in FSSAI, which then clears the product.

Proper health claims on labels specifically oriented towards dietary supplements is mandatory for marketing the product. Dr Raja Smarta MD, Interlink Marketing Consultancy

Post this, developing health and label claims specific to Indian regulatory guidelines is the major element of focus. Proper health claims on labels specifically oriented towards dietary supplements is mandatory for marketing the product. The label content is developed after the regulatory assessment of the product

FSSAI, although a significant step in eliminating hurdles, is relatively new. Organised players and industries are facing a slew of issues while dealing with the organisation, especially while going through the product approval processes. There still exists confusion about regulatory requirements in the minds of new entrants and established players. FSSAI currently deals with more than five crore conventional food business operators across the country. Dealing with this huge mass has become a hurdle as FSSAI is largely underequipped currently. It needs skilled and knowledgeable workforce, better infrastructure, scientific advisory panel, additional testing labs and upgradation of existing testing labs. Shetty says, “The 12th Five Year Plan was initially scheduled to sanction ` 5,000 crore to quickly upscale and strengthen FSSAI. However, the actual sanction of only ` 2,350 crore will definitely create a deficit and hamper and delay FSSAI’s plans of staffing, adding testing labs, infrastructure etc.” It is essential that the government takes immediate notice of these problems and addresses them effectively. While India is showing great promise as a formidable player in the nutraceutical market, co-operation and guidance from regulatory authorities is of utmost importance to steer this growth. At the same time, for the nutraceutical industry, strict compliance to the laid norms will not only ensure smooth business operations, but will also help in averting long-term adverse effects, toxicity, genetic disorders related to substandard products. Shetty concludes, “The industry is waiting to see FSSAI build strength, regulate the market and streamline and accelerate the process of product approvals, so that the nutraceutical market in India can be built to the best of its potential and can eventually become a strong player in the global market.” Properly regulated nutraceuticals can thus bring about positive changes in an individual’s health.

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Special Focus: Interface

Since nutraceuticals would be the thing of the future and the future of things, it is an undisputable conclusion that lot of big companies will enter the nutraceuticals market …says V S Reddy, Managing Director, British Biologicals. Here, he talks about the fast changing nutraceutical scenario in India. Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

How has British Biologics evolved in the last few years? Twenty years ago, a cancer patient undergoing chemotherapy dealt with internal burns. A patient with renal failure underwent dialysis and needed to control the intake of certain foods. A diabetic avoided carbohydrates to maintain blood glucose levels. A pregnant woman went to a doctor and returned with a handful of tablets to sustain a healthy pregnancy. A menopausal woman lived through the torment with help only in the form of hormone replacement therapy. Flash forward to 2013, when we have a palatable nutritional supplement to counter the side effects of chemotherapy, a supplement which ensures the mandatory 2200 calories to a diabetic who is forbidden

A good number of people who were only used to drug treatments are now aware of the importance of proper nutrition and nutraceuticals. Thus, they are naturally drawn towards preventive rather than curative treatments. most foods, a palatable supplement for pregnant woman which can do away with medicines & helps her enjoy pregnancy rather than make her feel like a patient. British Biologicals evolved through continued research and development in the space of preventive health care. Today, we are a household name with our products available in more than 12 lakh retail outlets accross the country. Tell us about the current R&D happenings in the nutraceutical sector. While nutraceuticals as a segment is gaining momentum in India, it does not have a research base to it. Besides a couple of companies which are actively involved in R&D, there is not much research happening in this sector. British Biologicals’ forte is medical research. We are the only company in India to have highly accomplished dieticians, microbiologists, biotechnologists and food scientists in our research team. We are actively involved in the research of all sectors of nutrition, be it paediatric or gaeriatric. How beneficial, according to you, are the recent M&As /collaborations by pharma biggies for the nutracuetical industry? Since nutraceuticals would be the thing of the future and the future of things, it is an undisputable conclusion that lot of big companies will enter the nutraceutical market. We are sure that in a decade or two, the world will drift towards preventive nutrition instead of depending on antibiotics for treatment. Hence, the next decade will see many collaborative strategies and merger of strengths. How has the Indian consumer behavior with respect to nutraceuticals changed

over the last few years? Research into consumer behaviour has revealed that consumers would rather prevent diseases than suffer its consequences. A good number of people who were only used to drug treatments are now aware of the importance of proper nutrition and nutraceuticals. Thus, they are naturally drawn towards preventive rather than curative treatments. How is the phyto-pharmaceutical market picking up? The phyto-pharmaceutical market is still in its nascent stage and will remain so until business operators can back their products with sound research findings. Many of these companies are unable to clinically prove or justify the effectiveness of these products.

Where do you see the Indian nutraceutical sector 5 years down the line? The Indian nutraceutical sector will witness a 10 fold increase in volume and sales in the years to come. The increased awareness will drive market growth and consumption will double. What is your take on the changing regulatory scenario for nutraceuticals in India? In the past, Indian consumers have never been known to question a product’s efficacy. Given this scenario, it is really heartening to note that at last there is a regulatory system put in place by the Government of India to protect their interests. The consumer will now be ensured of high quality, science-based products and dubious products will be weeded out.

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Special Focus: Roundtable

Nutraceutical vs pharmaceutical industry: Is it a case of complementing or competing against each other? Pallavi Mukhopadhyay

Dr R B Smarta

pallavi.mukhopadhyay @network18publishing.com

Founder and Managing Director, Interlink Marketing Consultancy

Dr Jeethan Bendoor Consultant Physician, Neuvithrah Nutrition Pvt Ltd

With the increasing diseases burden all over the world, there is an increase in the consumption of medicines. There is a movement from developed nations to the emerging ones. The emerging nations are experiencing a change in the demographics wherein the incidence of lifestyle diseases is on the rise. The young population is keen on adopting preventive measures and means to stay healthy and fit. Moreover, the trend indicates that the market is shifting from curative ways of treatment to pre-emptive and preventive ways. Both pre-emptive and preventive methods of treatment depend largely on nutraceutical. A perfect example of a curative method would be microbes. Microbiome that live in the human body protect their host in lieu of food and shelter; thus being a vital part of the host’s wellbeing. A disruption in the microbes in the body can lead to serious health conditions ranging from obesity to diabetes, through heart disease, asthma and such lifestyle diseases. In pharma, these microbes are treated only when they are disturbed. Pharmaceuticals have a system centric approach wherein the affected body system such as the cardiovascular system, gastrointestinal system is treated separately. Similarly, nutraceuticals have a nutrition-based approach where the balance of the microbiome is always maintained in the body. If either of the system is used separate from the other then the patient’s recovery and resistance may not be as quick and effective. When a patient-centric approach is adopted then both pharmaceuticals and nutraceuticals would work hand-in-hand. So, they would not only carry out their individual functions but also aid each other for the quick recovery of the patient, instead of competing with each other.

The pharmaceutical industry has better resources - in terms of scientific published information, field staff and distribution outlets, and perhaps a larger end user reach when compared to the nutraceutical industry; they have also been front-runners in the business field of prescribed-healthcare products for several years. The nutraceutical sector is an emerging and fast-growing business arena reflected by the increasing trend in consumption of nutraceuticals by large by the public and people with health-related issues. It is, therefore, a no-brainer that this nutra sector is a low-hanging-businessopportunity fruit that both the industry The pharma players would like to pick and profit from. industry has provided However, it is important to understand several promising results and — keeping the end-users in mind — that this business opportunity brings along recoveries. This has help build with it great responsibility in the form a credible image in people’s mind. of ‘Responsible Nutrition’ that needs However, a gradual evolution of consumer to be understood and addressed. This needs oriented towards holistic living has means that either player has to research biological needs of nutraceuticals brought the nutraceutical segment under thoroughly, understand the complexity the spotlight over the last few years. of modern lifestyle changes that keeps Going forward, it remains to be seen changing as days go by and roll out how the two industries position awareness programmes for self and end-users -- all in order to ensure that themselves. Experts opine… nutraceuticals are not abused (ie, under or overused). The media and policymakers who are important stakeholders as well have to work towards ‘Responsible Nutrition’ -- meaning that publications (be it electronic still/moving or printed media) and health policies have to be carefully designed to ensure a healthy population. The nutra sector is an arena that will only benefit if both the industries work with each Dr Ashok Vaidya other and not compete against each other. Research Director, Kasturba Health Society – Medical Research Centre

Dr Ajay Tumaney Group Leader—Functional Food Development, The Himalaya Drug Company As Indians become conscious about their health, the market for nutraceutical products is beginning to pick up speed. According to a report by Frost & Sullivan, the Indian nutraceutical market valued at $ 1,480 million in 2011 could grow to $ 2,731 million in 2016. The report also states that functional foods will be the quickest growing category. Interestingly, majority of nutraceutical products are developed by pharmaceutical companies. As pharma companies already concentrate on formulating products for multiple health conditions, nutraceutical products with specific therapeutic benefits are a natural extension to their product portfolio. They already have the scientific knowledge and research expertise in place. Generally, physicians prescribe nutraceuticals to adults and children for general weakness, post-operative convalescence, prolonged illness and stress of varied aetiologies. It is also recommended by doctors for preventative care. By aiding overall wellbeing of patients, nutraceuticals often complement pharmaceutical treatment.

Recently, there is a global disenchantment with pharmaceutical industry for various reasons ranging from chemophobia to the industry-doctor nexus. However, this general lamenting on pharma performance is not always justified. Unlike pharma, nutra industry has grown from naturals and nutritionals. Pharma industry is focussed on diseases, whereas nutra emphasises on wellness, health and longevity. The latter are major ingredients in the very definition of Ayurveda and traditional Chinese medicine. Obviously, safety is paramount when a large healthy population ingests any product for an extended period. In the pharma industry, the therapeutic ratio can be compromised vis-à-vis severity of the indicated disease. But in nutra even a minimal adverse effect can put off the consumption of the products. In pharma, the products are global, whereas in nutra these have to cater to the local taste, perception and culture. It would be sometime before the degree of complementarity of pharma with nutra can be assessed. Meanwhile, even friendly mutual demeanour would suffice for both the industrial sectors. It cannot be overemphasised that the battle of pictograms and femtograms dominant in the drug field, as to safety, efficacy and quality, not be carried over to nutraceuticals, which are closer to foods and nutrition of everyday life. Pharma usually says ‘Your health is in your doctors hands through our drugs,’ whereas nutra should say ‘Your health is in your hands by wise choice among naturals, nutritionals and nutraceuticals with a healthy lifestyle.’

Editorial take It is imperative that every individual has access to responsible nutrition, and for this both the pharma and nutra sectors must work in tandem to convey credible information to the consumers about their products and avoid marketing gimmicks that endorse false claims. Moreover, the nutraceutical sector must support each product with infallible scientific evidence. The newly introduced regulatory norms have paved way for this.

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Facility Visit

SCHOTT KAISHA Pvt Ltd, Jambusar, Gujarat

Automation leading the pathway Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

oday, pharma packaging is a large industry worldwide and has become an integral part of a drug delivery system. With rising demand to comply with newer regulations and safeguard the product, companies are focussing on acquiring the best possible packaging for their products. Established in 1997, KAISHA Manufactures Pvt Ltd produced glass packaging for pharmaceutical products. Later, its Joint Venture (JV) with Germany’s SCHOTT in 2008 took KAISHA’s manufacturing prowess to a whole new level. Today, SCHOTT KAISHA manufactures glass parenteral packaging including ampoules, vials, cartridges and sterile prefillable syringes for a host of pharmaceutical companies nationally and internationally. SCHOTT KAISHA’s newly opened state-of-the-art facility at Jambusar, Gujarat, is a fully automated pharma packaging plant in line with international guidelines (ISO 9001). This greenfield investment of ` 136 crore has increased SCHOTT KAISHA’s production capacity in India by over 50 per cent to around 2 billion ampoules and vials per year. The facility is housed in an area of 20 acre with room to construct further production modules in the future.

With the global pharma packaging market estimated to grow at a CAGR of 8 per cent, this industry is witnessing rapid expansions and innovations. SCHOTT KAISHA’s recently inaugurated fully automated pharma packaging facility in Jambusar, Gujarat, has set a new benchmark in quality manufacturing in India. This article takes a look at what it takes to be on top of the game.

State-of-the-art facility The new SCHOTT KAISHA facility in Jambusar has 20 production lines for ampoules and 16 for vials. It uses high-end robotic feeding technology for tube loading and high-precision camera inspection systems for an efficient and consistent production process. This state-of-the-art tube loading and inspection system ensures strict tolerance levels that guarantee a reliable production process and consistent quality. These machines are equipped with a unique self-correcting facility. If the thickness of the glass varies from one station to another, an electronic sensor immediately picks up and ejects the variant. The machinery is imported from France and Germany. The vials and ampoules are checked and rechecked on all regards from internal and external diameter, to lip height and length on the automatic Euromatic vial inspection machine. Post this, they are also checked manually by a highly skilled workforce

in air-conditioned rooms for optimum efficiency. The unit has an ISO 15378 certification and underlines SCHOTT’s commitment to the GMP standard. The plant complements an existing production facility in Daman. Kairus Dadachanji, Managing Director, SCHOTT KAISHA, says, “All emerging markets today are witnessing growing pharma needs. More companies want to participate and invest in healthcare and it has become a sector of focus for local governments as well. Consumers are demanding an increase in the quality of products and all emerging markets are increasingly concentrating on quality control. SCHOTT KAISHA has taken a step in this direction.” This facility enables SCHOTT KAISHA to meet India’s increasingly sophisticated market demands in terms of quality, innovation and differentiation. This investment will result in better quality opportunities for Indian customers. Dadanchanji adds, “We manufacture in India mainly for its highly attractive and fast growing local market. While 70 per cent of the products are sold domestically, we export about 30 per cent of our production to markets worldwide. We supply to over 150 top pharmaceutical companies in India and abroad. Among them are Serum Institute, Cadilla Healthcare, Dr. Reddy’s, Strides, Sun Pharma, Neon Laboratories, Intas Pharma, Troikaa Pharma, Emcure, Merck, Pfizer, Novartis, Sanofi, GSK, AstraZeneca, Akorn, Pisa, Fresenius Kabi etc.”

Quality compliance For 125 years, SCHOTT has constantly worked towards improving its quality standards in glass tubing to accommodate evolving market demands and deliver maximum benefits to its customers.

Employee safety and training

Consumers are demanding an increase in the quality of products and all emerging markets are increasingly concentrating on quality control. Kairus Dadachanji Managing Director

Maintaining high quality standards has been a key global success factor for SCHOTT. SCHOTT has developed an information and tracking system for FIOLAX® that offers customers precise information on important manufacturing, material and quality parameters for every ordered batch. All details of the production process are tracked from the start of production and are available for a period of ten years from the date of manufacturing. Adding yet another feather to its cap, recently, SCHOTT has been appointed to participate in India’s national standards body. As a new Bureau of Indian Standards (BIS) member, it has now the privilege to support BIS in its efforts to ensure that glass products are safe, reliable and of highest quality in India.

SCHOTT gives top priority to health and safety management for its employees and conducts several programmes such as frequent employee safety training, secure workplace design, safety equipment, preventive healthcare and other health programmes. SCHOTT’s ‘Integrated Management System for Safety, Security, Health and Environment’ (IMSUEHS) provides the set of rules and organisational framework for safety, security, health and environment concerns. IMSUEHS also guarantees compliance with the international environmental management system standard ISO 14001 and the occupational health and safety management system OHSAS 18001 as well as energy management systems standard DIN EN 16001. All employees are trained in technical and organisational know-how to determine and analyse dangerous or stress situations, assess risks and to react accordingly. Annually, the corporate IMSUEHS auditors monitor the system and provide important feedback for internal IMSUEHS certification and upgradation.

SCHOTT tubing In 1998, the company established a model manufacturing plant for pharmaceutical tubing in Jambusar district (Gujarat). SCHOTT refitted it to produce the world famous FIOLAX® tubes for the Indian market. This FIOLAX® plant produces basic material for primary glass packaging products of highest quality. It also supplies FIOLAX® tubes to the new SCHOTT KAISHA pharmaceutical packaging facility, which is located right next to the tubing plant. The plant in Jambusar functions as a production hub for the entire region. In turn, the backup possibilities offered by SCHOTT’s production sites situated all over the world provide flexibility, reliability and security to SCHOTT’s partners in India.

Expansion plans

Ampoules manufactured using amber coloured SCHOTT FIOLAX glass tubes

Production lines inside the manufacturing unit

Observing a steady growth in demand, SCHOTT KAISHA is further building manufacturing lines in Jambusar. It is looking at additional investment of around ` 100 crore towards expanding pharma packaging products capacity. It is confident of a healthy overall market growth in the future and expects to cross ` 240 crore mark by the end of 2013.

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Insight & Outlook: Automation Trends

Innovations in PAT and QbD

Aiming for improved pharma manufacturing The much-talked quality concepts, in the recent past, include Process Analytical Technique (PAT) and Quality by Design (QbD), which leverage the drug quality aspects by large. Professor Bhupinder Singh Bhoop, Dean, Faculty of Pharmaceutical Sciences, Punjab University and Mayank Kumar Srivastava, Marketing Program Manager - Life Science Group, Agilent Technologies India provide an insight into these new-age concepts.

harma industry has grown by large with respect to in-process developments across the production lines as well as adopting enhanced analytical techniques in order to maintain the product quality. The status of the final product depends considerably on two major aspects: how the product quality is maintained during manufacturing and whether the product quality was analysed efficiently? Prof Bhoop and Mayank Srivastava discuss the impact and other related awspects of both PAT and QbD concepts.

Mayank Kumar Srivastava Marketing Program Manager, Life Science Group - Agilent Technologies India QbD implementation in analytical development Quality by Design (QbD) is a systematic approach to drug development, which begins with predefined objectives, and uses science and risk management approaches to gain product and process understanding and ultimately process control. While the traditional approach of product quality testing performed post manufacture has been successful in assuring product quality in general, there has been recognition by the pharma industry and the regulatory authorities that it led to a less efficient pharmaceutical development and manufacturing processes wherein the understanding of variability and risk is not built in. QbD concepts have gained significant importance over the past several years and regulatory authorities such as FDA have long been encouraging the pharma industry to implement QbD in pharmaceutical development and manufacturing. The aim of QbD is to make more effective use of latest pharmaceutical science and engineering principles and knowledge throughout the lifecycle of a product and implement a continuous improvement culture. A number of guidance documents such as ICH Q8, Q9, Q10 and Q11 are available for implementation of QbD. QbD approaches for analytical methods could logically involve understanding how analytical

results are affected by variation in input parameters, evaluating multivariate interactions originating from instrument, laboratory, sample, method parameters, analyst etc and incorporating prior knowledge of analytical techniques and methods. Implementation of QbD also warrants a closer look at impurities and degradation products.

Following solution aligns above QbD workﬂow: Automated method development solution with multi-variant analysis for evaluation of design space. Achieving significantly improved precision and lower detection limits for impurity analysis: Analysis of trace level impurities in the presence of large amounts of drug substances with Agilent HDR DAD solution. Achieving significantly improved precision in impurity analysis: Analysis of trace level impurities co-eluting with main compounds with Agilent 2D LC solution. Eliminating variability in method transfer with Agilent ISET solution. Eliminating variability in performance of transferred methods through automated/dynamic online mixing with 1290 quaternary pump solution. With the above alignment, pharmaceutical quality can be maintained and achieve a robust drug development process.

Professor Bhupinder Singh Bhoop Dean, Faculty of Pharmaceutical Sciences and Coordinator, UGC-Center of Advanced Studies, Punjab University, Chandigarh Since decades, adoption of systematic approaches has been yielding industrial products of diverse nature along with robust quality, enhanced resource economics and improved process capability. For the pharma industry, however, the strongest impetus was provided quite lately with the introduction of PAT and QbD guidance’s by ICH and US FDA as their prime 21st century quality initiatives. Their principal endeavour has been to accentuate sound science underlying the pharma manufacturing. Besides targetting the patient-centric QTPP and CQAs, the usage of risk management and FMEA approaches for thrashing CMAs and CPPs, and of Design of Experiment (DoE) for optimising the products/processes is usually considered as obligatory for the purpose. The latter approach of DoE is capable of delivering ‘breakthrough’ optimised systems amid numerous possible interactions with various excipients and processes, and requiring minimal expenditure of time, developmental effort and cost. Together with multivariate tools, DoE furnishes invaluable mechanistic understanding of the manufacturing process by unearthing the pertinent scientific minutiae behind the same. With myriad meritorious visages of this holistic QbD-based approach vis-à-vis the conventional culture of quality by inspection and/or testing (QbT), it is applicable to APIs, analytical development, manufacturing process and above all, to the drug products through a science lately christened as ‘Formulation by Design (FbD).’ Demonstration of quality amid the multidimensional ‘design space’ within the domain of ‘knowledge space,’ provides the much sought after ‘regulatory flexibility,’ even post approval. PAT framework provides the confluence technologies that integrate with QbD through data analysis, process control and regulatory compliance, thus supporting innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. In-depth understanding

of manufacturing processes can be obtained using Real Time Release Testing (RTRT) through PAT tools facilitating non-destructive in-line measurements to ensure the predefined quality. India is one of the largest producers of generic across the globe. Accordingly, the Indian pharma industry today is undergoing a somewhat dilemmatic and hectic phase, as all the generic products for US filing have to be now QbD-compliant. With the ‘evolution of a revolution’ already in place, everyone is speculating on QbD and the federal expectations on it. To me, it is a systematic approach driven by scientific knowledge towards product and process understanding, amenable to continuous improvement of quality throughout the product life cycle. Emphasis now is on provision of ‘...scientific evidence...’ instead of merely ‘....documentary evidence.....’ Endorsement of ICH Q8-Q11 and PAT guidances by federal agencies such as EMEA, MHRA, TGA, HSA, Health Canada, PMDA, MCC and ANVISA is a definitive testimony to the utility of such paradigms. Besides, several other regulatory bodies are seriously contemplating to embrace these guidance for better quality governance of pharmaceutical products or processes. The era ahead is forecasted to mark extrapolation of these QbD paradigms to biosimilars and complex generics too. Albeit QbD is applicable to all new ‘innovative’ drug products and/ or generics as yet, there are tangible issues for ‘retrospective QbD’ for products already existing in the market. ‘Portability’ of design space during scale up of the processes is also talk of the town in industrial milieu, which could be aided through process engineering approaches such as extensometry and chemometry. Notwithstanding, the challenges, issues and concerns on QbD and PAT guidelines, their implementation is eventually going in a win-win situation for all of these stakeholders namely, the industry, the regulators and above all, the patients.

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Insight & Outlook: Interface

It gives us joy when we are able to help scientists in solving complex scientiﬁc problems Hardik Ashar hardik.ashar@network18publishing.com

Kindly tell us about unique offerings from Waters. How can they be useful to pharma industry? Today, users ask for high quality products at the lowest possible cost; where cost is not the initial cost of purchasing but also the operational and maintenance cost. Our latest offering is UltraPerformance Convergence Chromatography (UPC2). This technology bridges the gap between Liquid Chromatography (LC) and Gas Chromatography (GC) thereby offering laboratories new options for tackling tough analytical problems. It expands the boundaries of reverse phase LC and GC separations and offers a replacement option for normal phase chromatography. This gives scientists the ability to precisely vary mobile phase strength, pressure and temperature. With this ability to fine tune the resolving power and selectivity of the system, scientists can exercise better control over the retention of analytes for separating, detecting and quantifying structural analogs, isomers and enantiomeric and diasteriomeric mixtures - all compounds that are often difficult to separate by any other means. Compressed CO2 offers numerous major advantages over liquid mobile phases or carrier gases that are used with LC and GC. For one, CO2 alone, or in combination with a co-solvent, is a low viscosity mobile phase that achieves higher diffusion rates and enhanced mass transfer than liquids used in HighPerformance Liquid Chromatography (HPLC). For another, when compared to GC, CO2 alone is a mobile phase that allows separations to occur at a much lower temperature. Scientists can routinely separate compounds that are less amenable to analysis by LC and GC including molecules having a wide range of polarities in larger spectrum with much higher resolution, sensitivity and speed. What gives your company an edge over other players? For more than 50 years, we have created business advantages for laboratorydependent organisations by delivering practical and sustainable innovation to enable significant advancements in areas such as healthcare delivery, environmental management, food safety and water quality worldwide. Waters is already a leader in technology sphere in which we are operating. We are known as pioneers and innovators in chromatography and mass spectrometry. What gives us an edge is our commitment to continuous and flawless support to our customers. When our customer buys a product or service, we ensure that our technology can help them to solve complex problems. Brief us about Waters’ COI initiatives. At Waters, our philosophy is simple. We believe in the power of science, technology and innovation. Waters Centers of Innovation (COI) programme was launched in 2010. It is a corporate initiative that recognises and supports

…says K V Venugopalan, President, Waters India Pvt Ltd, Bengaluru, India. In this succinct interaction, he discusses the recent trends in the exciting world of separation science and how Waters remains committed to support research. the efforts outstanding scientists and their institutions for research in the fields of life science, proteomics, metabolomics, systems biology, food and environmental chemistry, mass spectrometry and separations science. The programme is truly global working with scientists in countries such as Brazil, India, Ireland, UK, USA, Singapore and Sweden where Waters have initiated this programme. The programme is in line with our mantra and philosophy, ie The Science of What’s Possible. What kind of support is available to these scientists? They get complete access to all our technologies and technical resources.

We are always there to provide them the required priority support in terms of services, information and application support. It gives us joy when we are able to help scientists in solving complex scientific problems and we do celebrate it. Recently, we had a ceremony at St John’s Institute, Bengaluru, India, to recognise the research in structural proteomics in the laboratory of Prof (Dr) Amit Mandal. Much of his work has been focussed on understanding the structural biology of haemoglobin as it relates to disorders such as haemoglobinopathy and anaemia.

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

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,lâ&#x20AC;&#x2122;-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

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Projects

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Capacityexpansion of Halquinol BP-80 drug unit Project type: Capacity expansion Project news: Provimi Animal Nutrition India is planning capacity expansion of Halquinol BP-80 drug unit (from 30 TPM to 80 TPM). Project location: Bengaluru, Karnataka Project cost: NA Implementation stage: Planning Contact details: Provimi Animal Nutrition India IS-40, KHB Industrial Area, Yelahanka New Town, Bengaluru - 560 106 Karnataka, India Ph : +91 (0) 80-3368 0002 Fax : +91 (0) 80- 2846 1520 Email : info@provimi.in Fermentation facility to produce corticosteroids Project type: New facility

Project news: Symbiotec Pharmalab Ltd is planning to set up fermentation facility to produce corticosteroids. Project location: Indore, Madhya Pradesh Project cost: ` 450 million Implementation stage: Planning Contact details: Symbiotec Pharmalab Ltd Off A.B. Road, 385, Pigdamber, Rau Indore - 453 331, (MP), India Tel: +91 731 4200052 Fax : +91 731 4201222 Email : symbiotec@symbiotec.in Website: www.symbiotec.in Installation, testing & commissioning of waste condom shredding machine Project type: New facility Project news: HLL Lifecare Ltd is planning to install waste condom shredding machine at Peroorkada Factory, Thiruvananthapuram. Project location: Trivandrum, Kerala

Project cost: NA Implementation stage: Planning

Project news: Sparsha Pharma International Private Ltd is planning to set up narcotic drugs manufacturing unit.

Contact details: HLL Lifecare Ltd Mahilamandiram Road, Poojappura, Thiruvananthapuram - 695 012 Kerala, India Tel: +91-471 2354949 Fax : +91-471 2354949 Email : info@lifecarehll.com

Project location: Hyderabad, AP Project cost: ` 240 million Implementation stage: Planning

Installation of ultrasound machine Project type: New facility Project news: Kerala Medical Services Corporation Limited is planning to set up a ultrasound machine. Project location: Kerala Project cost: NA Implementation stage: Planning Contact details: Kerala Medical Services Corporation Ltd Thycaud P.O, Thiruvananthapuram -14 Kerala, India Tel: 0471 3045639, 3045600 Fax: 0471- 3045647 Email: engg_ep@kmscl.kerala.gov.in Narcotic drugs manufacturing unit Project type: New facility

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India t 5FM t 'BY t &NBJM QBSNFFU E!UFOEFSTJOGP DPN

Contact details: Sparsha Pharma International Pvt Ltd # 8-2-408, D-3, Sri Krishna Apts Road No: 6, Banjara Hills, Hyderabad - 500 034 Andhra Pradesh, India Tel: 040- 23352581/ 83 Fax: 040-23352880 Email : info@sparsha.com Setting up drug intermediates unit Project type: New facility Project news: Reeths Puffer Intermediate is planning to setting up drug intermediates unit in Uttar Pradesh. Project location: Musaffarnagar, Uttar Pradesh Project cost: NA Implementation stage: Planning Contact details: Reeths Puffer Intermediate Ram Ji Sadan 494- Kambal Wala Bagh, New Mandi Muzaffarnagar-251001 Fax : 0131-2602764 Email : rpdrugs@yahoo.com

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In Conversa

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Nathan Sigwort h Co-Founder and CEO, Pharmasecure

Baxter closes haemophili deal for potential a drug

Dear Reader,

Avastin unit dose syring recalled es eye infectiondue to potential

â&#x20AC;&#x2DC;Modern Pharmaâ&#x20AC;&#x2122; 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.

Special Focu s 14

Contract manufa cturing Offering cost-effe ctive uncertain econom solutions amid ic scenario

Baxter Interna tional Inc has acquisition closed its of a potenti al haemophilia treatment from Dr maker Ipsen the French drug K Anji Found er and Inspira Reddy , Biopharmaceu and tion ticals Inc. Chairm an Dr. Reddyâ&#x20AC;&#x2122; that could s Laboratories of be worth more in a deal passed away Ltd, recentl million. Baxter, than y based in Deerfie $ 180 Apollo Hospit of liver cancer at had said in the ld, Ill, al in Hydera January it considered bad. He was agreed to buy the drug, as the labeled OBI-1, in pharmaceutic drug discovery pionee manufacturing and related r al industry. operations. in life was to His Ipsen provide innova mission annou nced medicines at tive new Baxter a price that that agreed the could commo afford. $ 50 million to n man pay upfront, Dr Reddy $ 135 million up to obtain ed in milesto from gradu ne payments Unive rsity and a percen ation tage of Mumb specia lisatio is being studied of global sales. OBI-1 n in Pharm ai with as a possibl Science and aceuti cal for people Fine with acquire e treatment PhD in Chem Chemicals and d haemophilia A. OBI-1 later has National Chemical Engineering from orphan drug been designated an ical Labora tory, Pune. and the Europein the United States Dr Reddy will get years an Union, meaning it of if it is approv marketing exclusivity ed.

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Event Report

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Soon after his studie s, he the state-o wned IDPL served in founded the before he was honou company in 1984. He red by the of India Government with the Padma one of the highest Civilia Bhushan, India, recogn n Awards in ising his service of distinguished high order of Trade and Indust in the field CNBC TV18 ry. In 2012, confer red the Achievement Award (IBLA Lifetime for being ) on him a visionary who had spent a lifetime building up into a coloss his compa ny us with a puttin g Indian industglobal reach world map. ry on the

Water relea ses ne analyticalssta ndards anwd products in the reagents po rtfolio

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Event List

N AT I O N A L E V E N T S PharmaLytica Summit PharmaLytica Summit will deal with the developments made in the field of analytical instruments.Paper & abstracts submission, panel discussion and workshops will be seen. The conference will provide a platform to speakers. This summit will emphasise on impurity control in formulated product, reduction of failures during scale up, impurity identification and quantification, importance of particle size during product development and formulation analytical techniques; May 10-12, 2013, TBA, Mumbai. For details contact: CPHI, United Business Media India Tel: + 91-22-6172 7272 Fax: +91 22 61727273 Email: chaitali.patil@ubm.com Website: www.cphi-india.com

4th Scm Pharma Summit Scm Pharma Summit will deal with the advances made in pharma supply chain of India. The Summit will emphasise on practical supply chain strategies, impact and implications of new pharmaceutical pricing policy on nationally list of essential medicines on the supply chain, advantage of having optimsed warehousing strategies as per geographical constraints to save costs, best practices in the integration of current supply chain models; May 11-12, 2013, TBA, Mumbai. For details contact: CPHI, United Business Media India Tel: 91-22-6172 7272 Fax: +91-22-61727273 Email: chaitali.patil@ubm.com Website: www.cphi-india.com

ADME & Toxicology 2013 and â&#x20AC;&#x2DC;Nanomedicineâ&#x20AC;&#x2122; 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 â&#x20AC;&#x2DC;hotâ&#x20AC;&#x2122; 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: enquiries@selectbiosciences.com Website: www.selectbiosciences.com/ 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

HYDERABAD

Andhra Pradesh, May 31- June 3, 2013 Indiaâ&#x20AC;&#x2122;s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. R5 &95fhh5iffi5jlkg5R5 295fhh5iffi5jjoo5R5 ' #&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 â&#x20AC;&#x201C; 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com

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: info.india@ubm.com Website: www.ubmindia.in

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: www.waset.org/ conferences/2013/bangalore/icbbpe/

I N T E R N AT I O N A L E V E N T S Pharmaceutical Research Conference for Pharmacy Students & Young Graduates Themed â&#x20AC;&#x2DC;Meeting of the inquisitive minds: translating research into realityâ&#x20AC;&#x2122;, 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: secretariatprc@cybermed.edu.my Website: http://prc2013.weebly.com/

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: NĂźrnbergMesse Brasil Tel: +55 (11)-3205-5000 Fax: +55 (11)-3205-5070 Email: fcepharma@nm-brasil.com.br Website: www.fcepharma.com.br/en/

The Clinical Genome Conference Bio-IT World and Cambridge Healthtech Institute will host the 2nd Annual TCGC: The Clinical Genome Conference is inviting stakeholders from all arenas impacting clinical genomics to share new findings and solutions for advancing the application of clinical genome sequencing. The conference will bring together many constituencies for frank and vital discussion of the applications, questions and solutions surrounding clinical genome analysis, including scientists, physicians, diagnosticians, genetic counselors, bioinformaticists, ethicists, regulators, insurers, lawyers, and administrators; June 25-28, Hotel Kabuki, San Fransisco, CA For details contact: Cambridge Healthtech Institute Tel: 781.972.5400

Fax: 781.972.5425 Email: chi@healthtech.com Website: www.clinicalgenomeconference.com

International Congress of Toxicology 2013 The theme for the conference is â&#x20AC;&#x2DC;From Basic Science to Clinical and Environmental Outcomesâ&#x20AC;&#x2122;. 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: ict@ict2013seoul.org Website: www.ict2013seoul.org

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 Email:enquiry.sg@terrapinn.com Website: www.terrapinn.com

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: cebb@cbees.org Website: www.icebb.org 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.

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Event Report

iPHEX 2013

One-stop shop for buyers and manufacturers Pallavi Mukhopadhyay & Anubhav Sharma pallavi.mukhopadhyay @network18publishing.com

he Indian pharma industry is witnessing an upward growth trajectory. India has emerged as a pharma hub and is continually striving to provide quality medicines at affordable prices. Mumbai, being one of the major pharma export hubs, was rightly chosen as the destination for national as well as international buyers, regulators, policymakers to network, facilitate business meetings and further the vision of ‘Brand India.’ Pharmexcil, with the help of Ministry of Commerce & Industry, Department of Commerce and Maharashtra State Government made this possible by organising iPhex 2013 at the Bombay Exhibition Centre from April 24-26, 2013. It served as a platform for global investors, regulators, policymakers from the pharma industry to witness the growing commitment of Indian pharmaceuticals to serve on a global platform.

Star-studded event The event was inaugurated by the Chief Guest, Prithviraj Chavan, Chief Minister, Maharashtra and Special Guest of Honour, Rajeev Kher, Additional Secretary – Ministry of Commerce and Industry in the presence of Dr G N Singh, Drug Controller General of India (DCGI). India’s current pharma export share is $ 13 billion. With a vision to double this figure in the next two years, Chavan said, “India’s highly skilled human resources need to be gainfully deployed. A balanced approach that harmonises both innovation and expansion is essential for further growth.” He also assured that modern warehousing facilities would be created along with well-equipped exhibition centres and infrastructure would be revamped to ensure smooth sailing for new investors. Kher said, “This congregation will help India’s pharmaceutical industry now considered as ‘Pharmacy of the world’ to contribute to the global health care sector with a wider choice of highquality, affordable and accessible APIs/ generics. Going forward commercial discipline and innovation must be added to produce unbeatable products.”

Exhibition cum education Senior regulators from 20 nations such as Ghana, Tanzania, Taiwan, Vietnam, Egypt were present to understand the domestic manufacturers and the Indian market. iPhex brought together various domestic and international regulatory bodies under one roof. Bhavin Mehta, Chairman, iPhex 2013, said, “To make the maximum use of this opportunity and provide the best possible help to SMEs, we have arranged various conferences and meetings.” This made it possible for the domestic manufacturers to meet foreign regulators who helped them understand their expectations. The event was not only a platform to only exhibit the best of India but also one to exchange knowledge. Officials from the Ministry of Health were present at the event. Foreign delegates were invited to witness operations and processes undertaken by the Indian pharmaceutical industry.

In order to promote ‘Brand India’, Pharmexcil with the support of IDMA and the Ministry of Commerce & Industry recently organised iPhex 2013. iPHEX, primarily an Indian pharma show, aimed at showcasing India’s pharma manufacturing prowess to the world. It served as a good platform for interaction between the national and international delegates. Read on to find out further details… Well begun is half done!

Chavan lighting the lamp

In its first year, iPHEX 2013 witnessed the presence of 250 stalls exhibiting Indian pharma companies such as Ranbaxy, Lupin, Glenmark, Mylan, Mankind etc. Over 5,000 trade visitors including overseas buyer, delegates from highly regulated markets like USA, Europe, Australia, and 3,000 Pharmexcil registered members were seen. SMEs occupied about 60 per cent of the total exhibitors painting a picture of a very robust, competent and competitive Indian pharma sector. Further, iPhex will be an annual event where manufacturers from India and other nations can interact and share expectations on one platform. This will be instrumental in taking India’s pharma export share to a whole new level.

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Book Review Performance of Pharmaceutical Companies in India

Editor: Mainak Mazumdar

The Indian pharmaceutical industry has grown leaps and bounds in the post independence era. It has come to be regarded as a formidable player in world market. The first chapter sets the pace by dwelling into the history of growth of this industry and the various studies done on it. Chapter 2 goes on further into details of the evolution of Indian companies, the market structure in India, R&D philosophy and the concerns of the MNCs (innovator companies). Chapter 3 describes the heterogeneity in measuring efficiency in the Indian industry. It dwells into the mathematical models of different types of measurable efficiency. It concludes that the large companies will have to invest heavily in R&D to maintain output efficiency while the smaller player will have to exhibit more vertical mergers to sustain growth in the long run. Chapter 4 looks at the industry from a domestic or a global perspective, and concludes that more productivity can be gained by large firms by exporting into regulated markets. Smaller firms need to integrate and collaborate more often with MNCs to reach the same goal. Chapter 5 is dedicated to the Malmquist Productivity index. Chapter 6 deals exclusively with profitability and measures of the same. A great thesis, but needs an advanced knowledge of mathematics and economics to understand its full potential. Great book for entrepreneurs, company CEOs, policymakers and economists.

Price: ` 7,405

Publisher: Physica â&#x20AC;&#x201C; Verlag Distributor: Sci-Tech Books and Periodicals, 414 Janki Centre, Veera Desai Road, Andheri West, Mumbai - 400053, Tel: 022 66970507/26735260, Email: scitech@vsnl.com

Formulating Poorly Water Soluble Drugs Editors: Robert O Williams III, Alan B Watts, Dave A Miller Price: ` 16,182

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

One of the most fundamental property of a new chemical entity which determines its future as a drug formulation, is its water solubility and hence its bioavailability. A large number of NCEs during development today face the problem of being poorly water soluble. The editors have put together a wealth of material derived from experienced authors in the field of pharmaceutical sciences and manufacturing in this book. The book starts of by elaborating the problem of solubility and the significance of the same in new drug development. It stresses on the oral, parenteral and the pulmonary route of administration of these drugs. Chapter 2 explains the various parameters and tests performed to test the solubility of a chemical entity and hence characterisation of the problem. Chapters 3 â&#x20AC;&#x201C; 13 describe in detail the various methods adopted in order to improve solubility namely salt selection, particle size reduction, co-solvent selection, cyclodextrin complexes, gelatin dosage forms, liposomal parentral formulations, self-emulsifying lipid formulations, development of amorphous systems, etc. The final conversion into dosage forms via melt extrusion and spray drying techniques are explained in dedicated chapters. The book ends by devoting a chapter on quality control, regulations and upscaling of these techniques in the industry. Each chapter is made simpler with flow diagrams, graphs, illustrations and pictures. A must have book for every pharmacuetical scientist, pharmacist, regulator, student and enterprenuer. Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

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In Convers

ation With

Dr Ruchi Dass Founder, Health Consulting cursor Group

Dr Fran k Heinricht Chairman appo Managem of the Boar inted ent of SCHOTT d of AG The

13 Special

Focus 14

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Agility Ind controlled ia inaugurate s its ďŹ r facility for pharma st temperatur e near Nh ava Shev a Is the race stiflin

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Board and Labor to tions, with optim and rating the will take Dr Frank handling office on and high unsuitable storag humidity facility al stora June 1, 2013.Heinricht facilit costs associ e facilit ge and freight This custo ies. operations. ated with pharmies shipments Venus m bond at CWC Agility is in reefer ed facilit of the marketing signs weekly deparThe next step a vehicles y locate same Terminal Logistics Park and Antw for tures to with Sout rights for exclusive Facility, CFS, Hindd With Agilit to respective to delivery Rotterdam has all pharma erp. 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This can delive yâ&#x20AC;&#x2122;s zoled leading one of USFDA. -genericsâ&#x20AC;&#x2122;, -value trend for stically and is partic 4 mg/5 ronic pharm the world which patients. r additional mL is availa acid inject 2030? 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Products

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

Salt aerosol ﬁlter tester

Aqueous ﬁlm coating system

It is available in size 71cm W × 69cm D × 89cm H (28” W × 27” D × 34” H), weight 150bs (68kg), 0 . 0 7 5 μ m count median diameter, 0 . 2 6 μ m mass mean diameter and gravimetric standard deviation < 1.7. Concentration is 35 to 45 milligrams per cubic meter (mg/m3), efﬁciency upto 99.9995%, pressure 0 to 200 millimeters of water column (0 to 7.88 inches of w.c.), accuracy ± 2.5% of full scale, ﬂow rate 10 to 120 liters per minute (slpm or alpm). Power requirement is 110VAC/60 Hz or 220VAC/50Hz, compressed air is of 283 SLPM at 5.6 kg/cm2 (10 SCFM at 80 PSIG).

Four models for coating application have been developed. Instacoat EHP 250 is a single polymer PVA based coating system which has excellent water solubility and ability to perform at very high reconstitution level of 25%. Instacoat EMB is a single polymer (PVA) based tablet coating system and has excellent moisture barrier properties at 20% reconstitution level. Instacoat EEN is Methacrylic acid co-polymer (Type A or Type B or mixture of both) based optimised weight gain enteric coating system with 8-10% reconstitution level. Instacoat EHA is a high adhesion HPMC based ﬁlm coating system at reconstitution level of 15%. The whole E-series ﬁlm coating system has excellent adhesion, moisture barrier and high spray rate without gun choking and in minimum possible time.

MeasureTest Corporation Mumbai - Maharashtra Tel: 022 - 23645282 Mob: 09869012701 Email: measuretest@yahoo.com Website: www.measuretest.com

Ideal Cures Pvt Ltd Mumbai – Maharashtra Tel: 022 - 4268 8700 Fax: 022 - 4268 8713 Email: info@idealcures.co.in Website: www.idealcures.co.in

High containment ﬁlter dryer

Steam steriliser

PSL’s aseptic/sterile filter dryers are designed and built to meet the strict manufacturing requirements necessary for aseptic/sterile processes. These filter dryers utilise gas liftoff mechanical seals, unique off-loading designs and have CIP (clean-in-place) and SIP (steam-in-place) capabilities. It features internal dust collector design for higher product yield and ease of cleaning. Minimum solvent volumes beneath mesh and direct heating tiltable filter dryer options are available. It provides highly efficient drying due to unique underplate heating system. Reflux cleaning can typically achieve less than 2.5 ppm. Tapered filter plate and seal design provides minimum product retention, differential mixing agitator achieves homogeneity and uniformed drying even with difficult cakes.

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

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

Machinfabrik Navi Mumbai - Maharashtra Tel: 022-67368200 Email: abk@machinfabrik.com Website: www.machinfabrik.com

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Products

Cold chamber

Sysmac automation platform

Stability chamber

The temperature range is 2° C to 8 °C with +1.5 °C accuracy and +2.0 °C uniformity. It features 21 CFR PART-11 Compliance, log data, event data, audit trail data, e-records and e-signatures, graphical analysis and data acquisition. Optional features like scanner, GSM technology, hooter system and extra tray are available.

It is a new automation controller NJ-Series t h a t integrates motion, sequencing, networking, RFID tracking and vision inspection. It comes with new software - sysmac studio - that includes conﬁguration, programming, simulation and monitoring and a fast machine network - Ether CAT - to control motion, vision, sensors and actuators. The NJ-Series incorporates an Intel processor with fan-free operation. It delivers a true integrated development environment (IDE). Sysmac studio also offers an advanced 3D simulation environment to develop and test off-line motion proﬁles such as cams & complex kinematics. Intellectual property (IP) can be safely secured using 32-character passwords.

Stability chamber is designed as per international standards to meet requirement of all registration authorities. This equipment offers superior temperature accuracy, humidity accuracy, minimum heat loss, better air flow for maximum uniformity of temperature and humidity. Stability testing is an integral part of formulation development. It helps to generate information, which permits well-considered proposals to be made for the shelf life of drug substances products and recommended storage condition. Stability data is required to be submitted as part of the dossier submitted to the regulatory agencies for licensing approval.

Mack Pharmatech Pvt Ltd Nashik - Maharashtra Tel: 2551 230877 Fax: 2551 230877 Email: info@mackpharmatech.com Website: www.mackpharmatech.com

Syringe ﬁlling machine

Pneumatic conveyor

Cold cabinets

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

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 efficiency. It lengthens filter life and maximises performance with a standard reverse pulse jet filter cleaning system that keeps the filter clean and at optimum operating efficiency. The standard size access doors allows for easy filter replacement in less than five minutes without the use of any tool. The compact and integral blower eliminates the need for air piping and makes installation easier.

The REMI cold cabinets are designed for bio sample storage. The intelligent controller helps maintain temperature in case of sensor failure. The data stored in PC server with Lan connectivity can be monitored on any PC with password authentication. The machine is filled with PUF insulation to eliminate void pockets and the powerful fan motor is for forced air circulation to maintain uniform conditions inside the chamber.

Supremo Line & Control Ahmedabad – Gujarat Tel: 079-22205282, 22205181 Email: supremoproduct@gmail.com Website: www.supremoproduct.com

Hapman Systems Pvt Ltd Vadodara – Gujarat Tel: 0265-2517505 Email: info@hapman.in Website: www.hapman.in

Omron Automation Pvt Ltd Mumbai - Maharashtra Tel: 022-42288400 Email: in_enquiry@ap.omron.com Website: www.omron-ap.co.in

Spray dryer and encapsulator

The work bench features steel frames, panels and shutters made from prime quality CRCA steel. This steel is coated with epoxy paint and a special encapsulated powder that has a ﬁlm thickness of 40-60 microns. This imparts a high scratch-resistance and the encapsulated powder ensures that no oil or chemical marks are formed on the surface. Every shelf on the cabinet is equipped with a load carrying capacity of 40 kg UDL to ensure maximum efﬁciency in the cabinet drawer.

This SIP and CIP system has a CIP module which is activated by a PLC and complies with 21 CFR part11 of USFDA. This system is equipped with a positive valve and an open/close indicating sensor and is provided with a supply pump and a return pump with auto draining system. It comes with complete automatic operation and has user definable parameters. The system displays on-line view of process and fault messages. Its features include: restart of cycle from the same stage where stopped due to power failure or fault, printing of process parameters, storage of parameters, etc. The manufacturing vessel is available in portable-or stationary-type according to CGMP and ASME standards.

Godrej & Boyce Mfg Co Ltd Mumbai - Maharashtra Tel: 022-67964363, Mob: 09920113138 Email: arunp@godrej.com Website: www.godrej.com

Vyanktesh Fabricraft Pvt Ltd Nashik – Maharashtra Tel: 0253-6602691/2383603 Email: vyankteshen@yahoo.co.in Website: www.vyankteshfabricraft.com

S p r a y drying and encapsulation are attractive te ch n o l o g i e s f o r production of nano and microparticles of different substances and polymers. The technology allows fast processing times with small batches at high yield. Spray dryer allows a visible process from the nozzle outlet to the powder collection. It indicates the drying properties and behaviour of the sample in aqueous or organic solvents. Similarly, the encapsulator also allows visible process from the nozzle outlet to the bead collection. Two models of Spray dryer and two models of encapsulation are available to produce particles from 300 nanometers up to 2000 microns. It is useful in scenarios like solubilisation of new molecules in nano scale, microparticles for research on inhalers and parenteral,

Work bench

encapsulated beads for taste masking, targeted and sustained release and odorless products. Buchi India Pvt Ltd Mumbai - Maharashtra Tel: 022-66775400 Fax: 022-66718986 Email: india@buchi.com Website: www.buchi.in

SIP and CIP system

Marchesini Group India Pvt Ltd Mumbai – Maharashtra Tel: 022 67082755/64 Fax: 022 67082761 Email: Indiaphilippe@marchesini.in Website: www.marchesini.com

J. Noelraj (Team Leader - Marketing) Trident Pneumatics Pvt Ltd

Sarbi Mumbai – Maharashtra Tel: 022-26049538 Email: sarbi1@vsnl.com Website: www.sarbi.com

PTFE-lined valves This machine is equipped with a stoppering system that completely eliminates any air left between the product and the stopper. The typical balcony-design structure and the oval shape of the machine guarantees better access to the inside, clearly separating the mechanical drives from the filling area as well as simplifying the use of typical protection systems (laminar flow): all these specifications meet the “clean concept” requirements of this industry. The syringes are loaded semiautomatically and a pick and place system loads the empty syringes in the relative puck. The filling unit, which utilises three brushless tracking motors, dispenses the exact amount of product and ensures maximum precision for liquids but also for viscous solutions. The machine is equipped with a station that ejects noncompliant syringes and a pair of gloves on the front protection panel so that operators can intervene without having to open them.

One must look after ease of operation. He/she as should know how to operate the product so to avoid technical errors and incorrect output.

Remi Elektrotechnik Ltd Mumbai – Maharashtra Tel: 022-40589888 Mob: 09820627422 Email: sales@remilabworld.com Website: www.remilabworld.com

Lyophiliser The lyophiliser is used for pharmaceuticals, biotechnology and allied industries. Lyophilisation is the preferred drying process, for heat labile substances or where any physical, chemical or enzymic changes are detrimental to the products and its applications. Sublimation of frozen ice directly in the form of vapour under high vacuum is the basis of lyophilisation process. The system offers optimal ﬂexibility in programming the recipe to suit a wide variety of products. The drying chamber is designed for full vacuum and overpressure of 2.5 bar. Machinfabrik Mumbai - Maharashtra Tel: 022-25555596 Email: machinfabrik@vsnl.com Website: machinfabrik.com 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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Marketplace

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30 List of Products & Advertisers Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Product

Pg No

Product

Pg No

Product

Pg No

Product

Pg No

Access control ....................................................... 29

Connector..................................................................... 19

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

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

Acoustic enclosure ...................................................6, 21

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

Informatics............................................................ 15

Roots blower ............................................................6, 21

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

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

Label ....................................................................... 29

Salt aerosol ﬁlter tester ........................................ 21

Air shower controller .................................................. 29

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

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

Servos ..........................................................................BIC

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

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

Loniser ............................................................................ 3

SIP and CIP system ..................................................... 28

Analytical and instrumentation special .................... 29

Door interlock system................................................. 29

LVS BIC

Spray dryer and encapsulator .................................... 28

Analytical instrumentation ........................................ 15

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

Lyophiliser .................................................................... 28

Stability chamber ......................................................... 28

Aqueous ﬁlm coating system ..................................... 21

Dry van pump .......................................................... 6,21

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

Steam steriliser ............................................................. 21

Barcode patient ID band ..................................... 29

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

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

Syringe ﬁlling machine ............................................... 28

Bearing .......................................................................... 19

Electric actuator and gripper................................ 3

Mrfrs of thermoplastic valves and piping

Sysmac automation platform..................................... 28

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

Empower ...................................................................... 15

system from polypropylene.......................................... 8

Tefzel HHS Isotactic P.P material ........................ 8

Cable carrier ......................................................... 19

Exhibition - Plastivision 2013 .................................... 10

Pass box inter lock system .................................. 29

Three parameter display ............................................. 29

Cable connector ........................................................... 19

Fire alarm .............................................................. 29

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

Turnkey solution for Biotech and pharma

Chain............................................................................. 19

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

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

industry ........................................................BC

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

Guided compact pneumatic cylinder .................. 3

Pneumatic conveyor .................................................... 28

Twin-screw co-rotating extruder ............................... 11

Cleanroom equipment and accessories .................... 23

Heart valve frame ................................................. 11

Printer ........................................................................... 29

Twin-screw element .................................................... 11

Cold cabinet ................................................................. 28

High containment ﬁlter dryer ................................... 21

PTFE-lined valve.......................................................... 28

UPLC ...................................................................... 15

Cold chamber .............................................................. 28

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

Pump.......................................................................... 6,21

Vacuum booster pump .................................... 6, 21

Columns and chemistries........................................... 15

HPLC ............................................................................ 15

Rapid endotoxin detection system..................... 29

Vacuum system ........................................................6, 27

Compact pneumatic cylinder ...................................... 3

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

Refrigrated compressed air dryer ................................ 3

Work bench ................................................................ 28

Advertiser’s Name & Contact Details

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Advertiser’s Name & Contact Details

Pg No

Airtech Systems (I) Pvt.Ltd.

Advertiser’s Name & Contact Details

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Everest Blower Systems

Pg No

Igus India Pvt Ltd

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Steer Engineering Pvt Ltd

T: +91 - 22 28592275

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E: sales@airtechsys.in

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All India Plastics Mfrs Association

Everest Blowers

Mitsubishi Electrical India Private Limited BIC

Tritan Technologies

T: +91-22-28217324

T: +91-11-45457777

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Charles River

Fabtech Technologies Intl Pvt Ltd

Reynders Label Printing India Pvt Ltd 3

UNP Polyvalves India Pvt Ltd

T: +91-80 - 25588175

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Chemical & Process World

GMP Technical Solutions Pvt Ltd

FIC

Salesworth Synergies Pvt Ltd (Rommelag) 9

Waters (India) Private Limited

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W: www.gmptech.net

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Eltech Services Pvt Ltd

Great Eastern Impex Pvt Ltd

Sotax India Pvt Ltd

T: +91 40 27759895

T: +91-011-2347431/32

T: +91-022-42950191

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Our consistent advertisers

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