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EDITORIAL

A booster shot for Baddi… he story of Indian pharma would be incomplete without a mention of the pharma SEZs, which have played a key role in transforming the nation’s presence on the global map. From a predominantly import-dependent industry, today it has emerged strong, buoyed by considerable growth of indigenous companies as well as MNCs setting up their base here. A case in point is Baddi. Located in the Solan district of Himachal Pradesh, it has positioned itself as a major investment destination, especially for the pharma sector, thanks to a slew of tax holidays offered by the government. Also, in the process it has attracted its counterparts in chemicals and packaging industries, which in turn has strengthened growth of the pharma units. However, now there is a need to go beyond the tax stimulants to further the growth of this vibrant SEZ. Some of the key issues that need priority attention include rising costs of real estate, difficulty in attracting outside talent, infrastructure bottlenecks, and connectivity with major pharma hubs in the country, among others. For further insights on Baddi, turn to the ‘SEZ Focus’ and ‘Region Outlook’. One of the recent trends observed is the convergence of food manufacturing with pharmaceuticals. Welcome to the world of

t

nutraceuticals! Some of the global growth drivers of this sunrise sector include growing number of ageing population, rising desire towards natural products rather than synthetic derivatives to lead a healthy and productive life. In fact, by incorporating dual benefits of both food & medicine, nutraceuticals are extending their application footprints. These also hold potential to compete not only against basic products (eg, raw fruits & vegetables) but also latest pharmaceuticals. The ‘Industry Update’ highlights some of the key developments shaping nutraceuticals. In another interesting market segment, cosmeceuticals are coming of age by offering an extensive range of biologically active ingredients, promising drug-like benefits and a dramatic, rejuvenating effect on the skin! The ‘Market Trends’ has more on this. Last but not the least, it is alarming to see the gradual flooding of internationally banned drugs in the Indian market. The ‘Roundtable’ provides several expert perspectives on the causative factors as well as countermeasures to stop its spread. Read on…

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Editor: Manas R Bastia

December 2010

Modern Pharmaceuticals

13


CONTENTS

32

52

F E AT URE S IN DIALOGUE 'With easy availability of scientific manpower, India will soon become a dominant player in the international market' ...says Srikant Kumar Jena, Union Minister of State, Chemicals and Fertilizers

LEADERS SPEAK

41

'The vaccine market depends heavily on government purchases' ...says K V Balasubramaniam, MD, Indian Immunologicals Ltd

ROUNDTABLE Banned drugs available in India: Time to revisit regulatory norms? JB SEZ Pvt Ltd: Building inroads to the pharma world

SEZ FOCUS

36

41 42

REGION OUTLOOK

45

INDUSTRY UPDATE Nutraceutical segment: A logical progression for Indian pharma? Cosmeceuticals & health: Growing by leaps and bounds

RETAIL ZONE

REGULAR SECTIONS

Fraud and shrinkage in pharmacies: Battling the profit killers Rajendra Pratap Gupta International Healthcare Policy & Retail Expert Section 3(d) in pharma: Changing rules of the game Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra, IP law firm

IP MANTRA

National News ..................................................16 World News ......................................................24

TECHNOFOCUS

Tech Updates ....................................................28

RH Calibration in stability studies: Controlling variations for accuracy N M Mehta MD, Newtronic Equipment Company Pvt Ltd

Events Calendar................................................70 Technology Transfer.........................................78 Product Update ................................................80 Product Inquiry................................................89 Advertisement Inquiry .....................................91 Product Index ...................................................93 Advertisers’ List ................................................94

14 Modern Pharmaceuticals

December 2010

CASE STUDY SAS PheedIT: Clinical data management simplified

REPORT P-MEC & CPhI India 2010 : Placing India at the forefront

55 58

LEGAL EDGE

'In the race to get a drug to the market, it is likely that India can see a considerable opportunity coming into the country' ...says Dr Mike James, Co-director, Cambridge Regulatory Services (UK)

Editorial ............................................................13

48 52

MARKET TRENDS

62

36

Baddi, Himachal Pradesh: The rising pharma locale Baddi SEZ: Making the right moves? Hitesh Gajaria Executive Director, KPMG …more on Baddi: Meeting needs, connecting ends

58

33

39

FACILITY VISIT

33

32

62 66 68 72

Highlights of Next Issue Industry Update : Quality issues Market Trends : Pharma SMEs

Details on page no. 29, 30, 63, 64

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise Cover design: Chaitanya Surpur


NATIONAL NEWS

PREVENTION KIT

Cipla develops package to prevent HIV/AIDS transmission Cipla has developed a ‘Mother-Baby Pack’ in collaboration with United Nations Children’s Fund (UNICEF) and other partners, to help reduce mother to child transmission of HIV/AIDS. The pack contains a range of antiretroviral drugs and antibiotics required by an HIV-infected mother, starting from the 14th week of pregnancy until sixth week after delivery.

ANNOUNCEMENT

Strides Specialties rebranded

Venkat Iyer, CEO, Agila Specialties

Strides Arcolab Ltd has recently announced that it has renamed its

RESEARCH COLLABORATION

Bangalore institutes sign MoU with Maastricht University The National Law School (NLS), Indian Statistical Institute & National Institute of Mental Health and Neuro Sciences (NIMHANS) have signed a Memorandum of Understanding (MoU), with Maastricht Education and Research Centre (MERC), a subsidiary of University of Maastricht (UM). The MoU will help NLS in research collaboration and PhD supervision, with

BUILDING EXPERTISE

Clinical trials to attract foreign investments

Dr Ramakrishna, Deputy Drugs Controller (I)

Government of India is determined to bring about a boost in the clinical

16 Modern Pharmaceuticals

Dr Y K Hamied, Chairman, Cipla, said, “We were approached by UNICEF to produce this pack for the Prevention of Mother-to-Child Transmission (PMTCT) programme. Cipla is proud to extend its world-class antiretrovirals to infected expectant mothers, and the specially designed Mother-Baby Pack will increase adherence & play a pivotal role in the total PMTCT of HIV/AIDS”. Over 1,000 infants contract HIV everyday from their mothers at the time of birth, with the highest rate reported in the sub-Saharan

Africa. The risk of transmission during labour & delivery is high and about 14 per cent is attributed to breastfeeding. The MotherBaby Pack will help HIV-positive mothers in the remotest corner of the least developed world to access PMTCT drugs.

specialities division. ‘Strides Specialties Private Limited’ will now be known as ‘Agila Specialties Private Limited’. The name Agila reflects the brand ethos of Strides’ specialised product offering, which is smart, agile, determined and pragmatic. Concurrent to this announcement, Strides also announced the appointment of Venkat Iyer as Chief Executive Officer (CEO) of Agila Specialties. Commenting on this, Arun Kumar, Vice Chairman & Group

CEO, Strides Arcolab Ltd, said, “Against the rapid growth of our specialties division and the increasing role it is playing in our company’s growth, we felt the need for a new identity that will reflect our position in this dynamic & challenging segment of the healthcare industry. It also communicates our seriousness and intent to become the powerhouse in the steriles segment. Under the leadership of Iyer, we hope for Agila to grow in stature and reputation.”

NIMHANS. It will facilitate educational cooperation for curriculum development, innovative methodological approaches, student assessment – academic & cultural exchange and joint research programmes. With Indian Statistical Institute, it will focus on student exchange, academic & cultural exchange and staff exchange programmes. Dr V G Kumar, Executive Director, MERC, said, “We want to foster academic collaboration with the very best in

India and build on synergies in knowledge. The UM strategy is that the researches to be built have social relevance in this geography.”

trials industry to help attract foreign investments and projects. “The measures to be taken for improvements involve regulations, speeding up procedural process in clinical trials and creating institutions to further develop the talent pool. Although the country has taken giant leaps in many sectors, the clinical trial sector has not grown substantially,” said Dr R Ramakrishna, Deputy Drugs Controller (I), Central Drug Standards

Control Organization at the International Conference on Clinical Trials organised by CII in cooperation with many agencies. There is a need for the industry to shift from capacity building to competency development, from seeking outsourced project to seeking entire portfolios and achieve higher levels of operating efficiency through integration and transfer of noncore responsibility thus lowering the overall outsourcing cost.

December 2010

L-R: Prof Dr G G (Frits) van Merode, Dr Jo Ritzen and Dr Venkat Rao


NATIONAL NEWS

DRUG APPROVAL

Sun Pharma receives USFDA approval for generics Sun Pharmaceuticals Industries Ltd has recently received approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA). The approval will allow Sun to market a generic version of GRANT OF LICENCE

CSIR grants worldwide licensing rights to Nostrum

L-R: Prof Samir K Brahmachari, Kapil Sibal, Dr Girish Sahni, Dr Mulye, President & Founder, Nostrum Pharmaceuticals Inc, USA

LABORATORY APPROVAL

Intertek India’s pharma lab receives FDA approval Intertek India has received approval from the Food and Drug Administration (FDA), Maharashtra, to test pharmaceutical samples at its Thane-based laboratory. Commenting on the approval, Rajesh Saigal, Managing Director, Intertek India, said, “It gives us immense pleasure to announce that our laboratory in Thane is approved by the FDA. Gaining the right approvals

LAUNCH

Hyderabad airport introduces India’s first pharma hub

Lufthansa Cargo and GMR Group, the operator of Rajiv Gandhi International Airport, Hyderabad have recently announced their intention to develop the

18 Modern Pharmaceuticals

Schering Plough’s Clarinex tablets 5 mg. Clarinex tablets are indicated in the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. USFDA has approved another generic version of Cymbalta, duloxetine hydrochloride delayed-release capsules. These capsules with strength 20, 30 and 60 mg are indicated in the treatment of

major depressive disorder, generalised anxiety disorder and diabetic peripheral neuropathic pain.

The Council of Scientific & Industrial Research (CSIR) has licensed its constituent laboratory, Institute of Microbial Technology (IMTECH) to Nostrum Pharmaceuticals to clinically develop and commercialise new-generation (third & fourth) thrombolytic molecules. These clot busters comprise clinically beneficial thrombolytic molecules with enhanced half-life and target (fibrin/cloth) specificity. Dr Girish Sahni, Director, IMTECH, said, “Licensing of these molecules to

Nostrum is a proud achievement for IMTECH, especially as these are third- & fourth-generation molecules that IMTECH has licensed out to Nostrum, and should fill an acute need in the world, especially developing countries where effective but affordable treatments for circulatory disorders such as heart attacks & stroke are a crying need, and where the most expensive option of surgical intervention via cath labs is not an easy option.”

and certifications for products is extremely vital. With these, one company can ensure compliance and safety. Organisations must ensure that they have all required approvals in place, before launching a product.” Rupert Crasto, General Manager, Intertek India Oil Chemical, Agri & Mineral Division, said, “Our standard operating procedures are regularly reviewed & revised, the quality assurance systems are designed according to scientific principles, controlled precisely and monitored

closely to give reliable, reproducible & dependable results. Also, our reports are written clearly and precisely to reflect our strong scientific background, utmost care & quality work, with the ultimate aim of strengthening the regulatory compliance as well as supporting ethical duties of our customers.”

airport serving - the key cargo hub in South Asia for transport of temperature-sensitive pharmaceuticals. The two companies also signed an MoU. A modern state-of-the-art infrastructure will be established to meet the complex standards of reliable, temperaturecontrolled transport solutions. The customs procedure at the airport will also be speeded up to guarantee faster transportation. Lufthansa Cargo will be stationing its own fleet of cooling containers at the airport. Martin Schlingensiepen, Vice President Product Management,

Lufthansa Cargo, said, “India is the world’s largest market for generics. The demand for temperature-controlled transport will continue to grow in the coming years. This will enable us to offer our local customers tailor-made products for fast and reliable transport of pharmaceuticals.” P Sripathy, CEO, GMR Hyderabad International Airport, added, “Lufthansa Cargo’s expertise and modern infrastructure will enable us to offer our customers the best & most reliable products for cold chain transport in South Asia.”

December 2010


NATIONAL NEWS

AGREEMENT

Nichrome collaborates with Prodo-Pak Nichrome India Ltd has collaborated with Prodo-Pak Corporation, US to manufacture and sell high speed multi lane sachet Machines. Under this technology licensing agreement, Prodo-Pak Corporation will support Nichrome in transfer and upgradation of the technology. These machines will be for both domestic and international

DRUG LAUNCH

Ranbaxy launches donepezil

Ranbaxy Pharmaceuticals, Inc, has announced that Ranbaxy Laboratories Ltd (RLL) has received approval from the US Food and Drug Administration (USFDA) to manufacture and market

INAUGURATION

Lubrizol opens Applications and Business Center Lubrizol Corporation has recently inaugurated its new regional Applications and Business Center in Mumbai to support its advanced materials business segment, according to a press release. The laboratory includes development, formulation and applications testing capabilities in multiple personal care & coatings applications as well as pharma

EXPANSION

Bafna moves into European market

Bafna Pharmaceuticals has recently announced that it has received approval of its product finasteride for the EU market. Following the recent approval of amlodipine 5 mg and 10 mg, Bafna

20 Modern Pharmaceuticals

markets. With this technology, the company aims to offer machines with up to 15 lanes. Nichrome aims to promote this technology for segments like cosmetics & personal care, pharmaceuticals & nutraceuticals, capsules & tablets and swabs & tissues besides conventional applications like powders & liquids. John Mueller, CEO, Prodo-Pak Corporation, commented, “With Nichrome’s experience in packaging

machinery, we are sure that it is the right partner for business growth in India. This collaboration will lead to serving both the domestic and international markets with pre-eminent machines.”

donepezil hydrochloride tablets 5 mg & 10 mg with a 180-day market exclusivity in the US healthcare system. The brand name for this drug is Aricept, which is indicated for treatment of dementia of the Alzheimer’s type, and also in patients with mild-to-moderate and severe Alzheimer’s disease. Commenting on the launch, Bill Winter, Vice President, Trade Sales, Ranbaxy Pharmaceuticals, Inc, said, “We are pleased

to launch donepezil, which expands Ranbaxy’s portfolio of affordable generic pharmaceuticals. Ranbaxy’s generic formulation of Aricept will benefit the US healthcare system by providing a more affordable treatment option to patients, and will have a positive impact on escalating US healthcare costs.” The total annual market sales for Aricept 5 mg, and 10 mg tablets was $ 2.6 billion.

L-R: Vaibhav Modak, Harish Joshi and John eller

application development center. The site supports Lubrizol’s business in engineered polymers, which is known in India for its FlowGuardTM brand – a high-performance engineered plastic widely used for hot and cold water delivery. Eric Schnur, President, Lubrizol Advanced Materials, commented, “Lubrizol has a long history of investing in the South Asian market, particularly in India. We view this market as a great opportunity for Lubrizol

Advanced Materials and our new site represents an important step in what we intend to be a long-term effort focussed on growth & investment in this region.”

Pharma has now received the 14th approval from UK Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture finasteride 5 mg. Finasteride is an orally active testosterone 5 alpha-reductase inhibitor. It is used in Benign Prostrate Hypertrophy (BPH) or enlargement of the prostrate gland. Commenting on the approval, Mahaveer Chand Bafna, Chairman & Managing Director, Bafna Pharmaceuticals, said, “For BPH patients

whose disease is worsening and symptoms are moderate to severe, finasteride offers benefits of medicine and also provides doctors with an effective treatment option. Bafna Pharma has been constantly upgrading its manufacturing facilities to efficiently meet the anticipated demands of global markets. The approval from UK MHRA for finasteride 5 mg will enable Bafna Pharma to widen its customer base in Europe.”

December 2010

Lubrizol Applications and Business Center in Mumbai


NATIONAL NEWS

ACQUISITION

Marck facility

acquires

injectible

Marck Biosciences Ltd has recently acquired a large-volume injectible facility in Goa, according to a press release. The company will be stepping up its manufacturing capacity for high volume injectibles by over 33 per cent by March 2011. It has also taken over the assets of the Goa-based Ravish Infusion on

CERTIFICATION

Lifecell gains accreditation from CAP

LifeCell International has received accreditation from College of American Pathologists (CAP) under its Laboratory Accreditation Programme’. CAP

TAKEOVER

Cambrex Corp acquires 51 per cent stake in India’s Zenara for $ 20 million The New Jersey-based drug maker, Cambrex Corp, has declared that it has acquired 51 per cent stake in Zenara Pharma, based in Hyderabad, which had focussed on the formulation of final dosage form products worth $ 20 million. As part of the agreement, Cambrex will acquire the remaining 49

EXCIPIENT LAUNCH

Versatile ready-to-use excipient launched

Pioma Chemicals has introduced Granlak LS-G, a ready-to-use binder for tablet formulations. It is manufactured at Mingtai Chemicals Co

22 Modern Pharmaceuticals

a lock-stock barrel basis for a total of ` 547 lakh under an auction process from Debt Recovery Tribunal 2, Mumbai. Marck has also signed an MoU with Paragon Steels Pvt Ltd for purchase of its injectibles equipment worth ` 150 lakh. Commenting on this, Bhavesh Patel, Managing Director, Marck Biosciences, said, “The estimated market size for injectibles was approximately $ 140 billion in 2009. Marck Biosciences

is operating above 90 per cent capacity since last three years in large-volume injectibles. The acquisitions will help Marck Biosciences expand its capacity to meet the growing demand. With these two acquisitions, the total capacity for large volume injectibles will increase by 200 lakh bottles per year.”

accreditation is awarded for excellence and compliance to international regulatory, quality & safety standards of the laboratory. This accreditation has placed LifeCell on the international quality compliance platform, as it joins 7,000 other laboratories worldwide. Commenting on the accreditation, Mayur Abhaya, Executive Director, LifeCell International, said, “We are proud to announce the CAP accreditation of our

laboratory. it reiterates our commitment to setting new benchmarks for the stem cell industry by providing high quality of service to customers who bank their child’s precious life-saving stem cells with us.” The accreditation certifies overall management, test methodologies, specifications, reagents, equipment, specimen handling, test reporting and internal & external performance assessment.

per cent in early 2016 at a value based on weighted combination of a multiple of the 2015 cumulative Earnings Before Interest, Taxes, Depreciation and Amortisation (EBITDA) for years 2011-15. The Indian company will be renamed as Cambrex Zenara. Commenting on the merger, Ashok Narasimhan, President, Cambrex Zenara, said, “Cambrex, with its leading position in Western markets for the development & manufacture of Active

Pharmaceutical Ingredients (APIs) and its history of supplying products to the NRT market, is a natural partner for Zenara. Our technology and cost position will enable us to supply cost-effective products to our customers in both developed & higher growth markets.”

Ltd, Taiwan. It is a combination of highquality lactose, starch & Poly Vinyl Pyrilidone (PVP), has free flowing fine granulated powder, and is a ready-to-use product for direct consumption. It helps in producing cost-effective formulations to match the requirement and improves consistency & quality of the end-product. It also saves 70 per cent of the total time. The product can be converted into tablet formulation by mixing Active Pharmaceutical Ingredients

and Granlak LS-G, other ingredients like lubricant & disintegrated, followed by direct compression and finally into tablet product. It can also be easily converted into capsule formulation. Granlak LS-G has an allergen-free safe-to-use ingredient for formulation, excellent flow ability, quality, uniform mixing & release of the API, non-toxic excipient. It finds application in capsules, tablets, semi-finished formulations, dry mix, nutraceuticals, herbal and allopathic medicines.

December 2010


WORLD NEWS

LATEST ADDITION

USFDA publishes new import alert category

The US Food and Drug Administration (FDA) has published a new category for Import Alert related to Facility Establishment Inspections. The new Import Alert #99-32, ‘Detention without

INDUCTION

Dr Chris Beaver joins PharmaNet as Director, Immunochemistry Services PharmaNet Development Group, Inc, a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, has announced that Dr Chris Beaver has joined the company as Director, Immunochemistry Services. Dr Beaver will

EXCIPIENTS

ISP advances the science of solubility for pharmal industry

At the American Association of Pharmaceutical Scientists (AAPS) 2010 in New Orleans, ISP showcased its solubility science and diversified excipient

RESEARCH & DEVELOPMENT

Avesthagen’s first biosimilar molecule completes clinical batch manufacturing Avesthagen Ltd has recently completed the manufacture of clinical grade material of its first biosimilar molecule – AVDESP™ (biosimilar to Darbepoietin alfa) – and will move to clinical trials. Inno Biologics, Malaysia’s biopharma Contract Manufacturing Organisation, has successfully developed Drug

24 Modern Pharmaceuticals

physical examination of products from firms refusing FDA foreign establishment inspection’ (IA 99-32), entitles FDA with the enforcement right to refuse any product entering United States Commerce from a firm that refuses FDA of the right to inspect their manufacturing facility. Benjamin England, Founder, FDAImports.com, LLC and former FDA employee, said, “Although allowing FDA to inspect a foreign facility may result in undesirable comments on Form 483, it

is more detrimental to be automatically detained for denying the inspection.” All manufacturing facilities, of all FDA regulated products, are subject to intense FDA inspection for current Good Manufacturing Practices (cGMP), safety and sanitary conditions. Any facility, which does not comply with the strict FDA guidelines and regulations may receive enforcement FDA Notices of Action such as Warning Letters or Untitled Letters.

lead the immunochemistry team within the company’s bioanalytical laboratories and work to expand its large molecule services, including assay development & sample analysis for biomarker, Enzyme-Linked Immunosorbent Assay, radioimmunoassays, immunogenicity & cell-based assays. “We are excited to have Dr Beaver joining us. Dr Beaver brings to PharmaNet a combination of CRO leadership experience & technical expertise in large molecule

Dr Chris Beaver

bioanalysis that enhances our ability to support the drug development strategies of our clients. He is a valuable addition to our bioanalytical team,” said Dr Richard LeLacheur, Vice President, PharmaNet.

portfolio. ISP reiterated its commitment to a large toolbox of excipients that may be considered for enhancing the solubility of solid dosage forms, including Polyplasdone® ultra and ultra-10, new ultra-high purity grades of crospovidone. According to Philip Strenger, Senior Vice President, Global Pharmaceuticals, “As ISP is well-versed in drug-polymer matrix formulations and a host of excipient & processing technologies shown to improve the solubility of oral solid dosage forms, we can

leverage the knowledge in the development laboratory to help the pharma industry move their New Chemical Entities (NCEs) forward. Through the combined efforts of our Research & Development (R&D) team and in-house process technology experts in novel spraydrying and hot-melt extrusion production methods, ISP is helping the industry remove the stumbling blocks to pharmaceutical commercialisation. The same technologies can also be used to formulate improved drugs based on existing actives.”

Substance batches for AVDESP™ that will be used by Avesthagen for conducting clinical trials after formulation of the drug product in India. Avesthagen has also signed a letter-of-intent with Inno Biologics for commercial manufacture of two biosimilars - AVDESP™ and AVENT™. Dato’ Dr Mohd Nazlee Kamal, Group Managing Director, Inno Bio Ventures Sdn Bhd, said, “The accomplishment by the company’s subsidiary reflects the propensity and capacity of the Group to

December 2010

R to L: Dr Villoo Morawala Patell (right) and Dr Mohd Nazlee Kamal (left) at the press conference in Inno Biologics , Malaysia

pioneer Malaysia’s foray into the global biotechnology arena”.


WORLD NEWS

TRANSITION

Filtrona Coated & Security Products expands business under new MD

Mark Palmer

Following the acquisition of BP Labels in March,

BRAND AWARENESS

The Scott Partnership appointed by PRECOS to run global PR campaign Global B2B PR and marketing communications agency – The Scott Partnership – has been appointed by UK-based Preclinical Oncology Services Ltd (PRECOS), to lead a global PR campaign aimed at raising company and brand awareness. PRECOS, a leading pre-clinical research and development

ACKNOWLEDGEMENT

King’s College London in Waters Centers of Innovation Program

In a symposium and ceremony held at King’s College recently, Waters recognised researchers Professor David Cowan and

REVISING RULES

Researchers insist on guidelines for OTC labels There is a need for mandatory guidelines for labelling of Over-The-Counter (OTC) liquid medication for children, urged researchers who have found major inconsistencies in labels and dosage measuring devices. Researchers at the NYU School of Medicine reviewed the warning labels and dosing devices of 200 paediatric oral liquid OTC medications

26 Modern Pharmaceuticals

the Coated & Security Products Division of Filtrona plc (C&SP) had announced the creation of an enlarged label and narrow web flexible packaging business. Mark Palmer will assume responsibility for this new business, following the retirement of Andrew Wood as MD, BP Labels, in January 2011. The new business will operate under the Payne brand in all label markets and combine the tobacco & brand protection label operations of Payne Security with BP Labels. Mark Palmer, Managing Director, Labels, brings over 22 years of experience to the C&SP

business, with in-depth knowledge of both flexible packaging and authentication solutions. Commenting on his new role, Palmer said, “I am delighted to have been given the opportunity to further grow and develop our combined label operations under the Payne banner. I have been closely involved with the BP Labels team since the acquisition in March and look forward to building on the work and focus on delivering outstanding creativity, service & performance in label and narrow web packaging products to all our customers.”

company with specific focus on oncology, was launched as a spin-off from the University of Nottingham, UK, in September 2010. The newly formed company combines the innovation of one of the country’s leading universities with scientific background and expertise of multi-disciplinary scientists. This places it in an optimal position to deliver specialist services, backed by significant industry expertise and cutting-edge technology, to help both pharma and

biotechnology companies develop new anti-cancer drugs. Professor Sue Watson, Chief Scientific Officer, PRECOS Ltd, said, “The Scott Partnership has been selected because of its in-depth expertise and specialist knowledge of the life science industry.”

Dr Norman Smith for their ongoing work in the area of sports medicine & separation science. Waters Centers of Innovation Program is a new, corporate initiative, which recognises and supports the efforts of scientists facilitating breakthroughs in health & life science research, food safety, environmental protection, sports medicine and many other areas. “Our ongoing collaboration with Waters has helped us develop faster and more sensitive

analytical methods for sports drug testing,” said Professor Cowan. In addition to conducting research on sports drug testing, Professor Cowan’s laboratory has taken a lead role in developing methods of analysing so-called ‘date rape drugs’ that are typically undetectable in a victim’s blood as soon as 24 hours after administration, thus enhancing law enforcement efforts to establish evidence of a crime.

with dosing instructions for children under 12 years of age. According to lead author Dr H Shonna Yin, the team tested top-selling drugs produced by different manufacturers, identifying an unacceptable level of inconsistency in labels and measuring devices of OTC liquid medication for children. A number of reports on accidental overdosing in children as a result of the problem have led to this study. Also, study was conducted after the US Food and

Drug Administration (USFDA) issued a set of voluntary guidelines last year, which advocated greater consistency in dosing instructions and accompanying measuring devices.

December 2010


WORLD NEWS

TECHNICAL BENEFITS

Sage-N Research optimises data generation for SBMRI Sage-N Research, Inc, (Sage-N), world leader in computational proteomics, recently stated

SBMRI team with Sorcerer™

COLLABORATION

PRECOS Secures agreement with Janssen Preclinical Oncology Services Ltd (PRECOS) has signed a significant service agreement with a leading global pharmaceutical company Janssen Pharmaceutica N V (Janssen). The global contract will see PRECOS provide clinical tumour material, tumour model development, target validation and drug efficacy work to support Janssen’s oncology drug discovery, development and biomarker programmes.

BRAND RELAUNCH

PharmaNet to launch a new brand identity

PharmaNet Development Group, Inc, is launching a new brand identity and tagline, ‘PharmaNet Works For You’. The new brand and tagline will reflect the company’s promise to its clients to provide intelligent solutions to

APPOINTMENT

New president for Pfizer Pfizer, Inc, has announced that its Board of Directors has elected Ian C Read, 57, currently Head of the company’s global biopharmaceutical operations, as President, CEO and Director. Read succeeds Jeffrey B Kindler, who has retired from the company. On being elected, Read said, “I am honoured to lead an organisation with outstanding and dedicated colleagues

that the Sanford-Burnham Medical Research Institute (SBMRI), a private, non-profit research institute dedicated to finding cures for human disease, has implemented the Sage-N Sorcerer™ Enterprise proteomics platform. The company will use the system to enhance speed of data searches and increase data generation for its proteomics projects that range from identification of proteins in gel bands to quantitative total proteome & total phosphoproteome analyses. SBMRI’s Proteomics Facility offers Liquid Chromatography-tandem

Mass Spectrometry (LC-MS/MS)-based proteomics services to support the Institute’s researchers. After implementing the Sorcerer™ Enterprise platform, the SBMRI Proteomics Facility has enhanced search speeds, increased accuracy in analyses and ability to export data in several formats. Also, using a decision tree MS/MS method, the platform’s VersaSearch software provides high-quality results on these data files, which contain Collision-Induced Dissociation (CID) and Electron Transfer Dissociation (ETD) spectra.

PRECOS was launched as a spin-off from the University of Nottingham, UK in August 2010. Professor Sue Watson, Chief Scientific Officer, PRECOS, commented, “This global contract further strengthens the long-term relationship between PRECOS and Janssen & consolidates PRECOS’ evolution from a primarily academic background into an ambitious commercial entity, offering significant scientific expertise and delivering highly specialist services in the development of new anti-cancer drugs.”

Dr Martin Page, Vice President, Head Global Oncology Research, Janssen Research & Development, a division of Janssen Pharmaceutica N V, said, “Our agreement with PRECOS is a natural extension of our long-standing relationship with the University of Nottingham, and we look forward to continuing to build on our past successes.”

accelerate drug development programmes consistent with highest standards of regulatory compliance, quality & reliability. The new branding unifies PharmaNet’s message across all its subsidiaries and services, and clearly articulates the company’s commitment to client service around the world. PharmaNet has the global reach and experience to execute clinical development programmes from small local projects to large global programmes with a custom-fit

philosophy that provides a personalised approach to client service. “The trusted PharmaNet name now serves as the umbrella brand for all our global clinical development service offerings. This investment in PharmaNet’s future demonstrates commitment to our clients and provides a solid foundation for our continued expansion of services, geographies & capabilities,” said Jeffrey P McMullen, CEO, PharmaNet.

on the front line of medical innovation. We have a broad portfolio that spans the entire spectrum of human & animal health, from vaccines to biologics to primary care, specialty care, oncology, consumer products, nutritionals and beyond.” He elaborated, “I have great confidence in the strength of the company and our leaders and will be looking at the performance & potential of our entire business to ensure delivering value to our customers & shareholders.

We have all the elements for success – financial strength, global reach, disciplined focus on therapeutic areas with the strongest growth potential and a talented & dedicated workforce.” Since 2006, Read has led Pfizer’s Worldwide Biopharmaceutical Business. He was responsible for managing more than 40,000 Pfizer colleagues.

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TECH UPDATES

Thermo Fisher Scientific launches Mass Frontier 7.0

Waters® Empower™ 3 answers call for a standardised CDS at enterprise-level

Thermo Fisher Scientific, Inc, launched Mass Frontier 7.0, its latest version of small molecule structural elucidation software. The software simplifies the management, evaluation and interpretation of mass spectral data and can be used for metabolism, metabolomics, forensics, natural products, impurities and degradants research. Thermo Scientific Mass Frontier 7.0 software delivers unique features that improve ease-of-use, increase throughput of compounds analysed, reduce potential for false results and offer more confident structural elucidation. The new software features an enhanced Fragment Ion Search (FISh) screening tool that includes automatic localisation of the site of biotransformation through colour coding applied to fragments common to the parent compound and its related component. Mass Frontier 7.0 software is enhanced with new chemically intelligent tools that accelerate the interpretation of mass spectral data. “Mass Frontier 7.0 software has many unique features that are not in any other software program. Structural elucidation is a time-consuming and labourintensive process to manually interpret spectra; however, Mass Frontier 7.0 software with its unique new features has significantly improved our workflow,” stated Dr Ji Ma, Screen shot of Mass Frontier 7.0 spectral interpretation software Principle Scientist, Amgen.

Waters Corporation recently introduced Waters® Empower™ 3 Chromatography Data System (CDS), a scalable, enterprise-wide CDS platform that can be rapidly deployed to easily fit into existing corporate infrastructure. Dr Rohit Khanna, Vice President - Marketing, Waters, said, “One of the most important challenges that laboratory scientists and information technology managers face today is the need for data management standardisation. Many of our customers are forced to support multiple laboratory software and informatics platforms among their many laboratories. This inconsistency is often traced to a merger or acquisition, or perhaps legacy systems from multiple manufacturing and R&D sites. Regardless of the reason, these companies suffer from inefficiencies that directly affect their bottom line. Addressing this issue of standardisation, Empower™ 3 CDS is designed to bring significant value to science-driven organisations at the enterprise level.” Specifically, customer benefits of CDS standardisation include reduced training efforts and support resources needed to maintain a single platform. Further, Empower™ 3 offers a variety of usability and workflow enhancements that help streamline customers’ daily workflow & efficiency. The additional calculation capabilities allow the ability to determine current signal-to-noise requirements according to regional pharmacopoeias in the US, EU and Japan.

Enhanced OmniView® 360° inspection system

Microneedles likely to be helpful in cancer treatment

Cognex Corporation has announced its next-generation OmniView® 360° inspection system, now with colour and five megapixel high-resolution cameras. OmniView® allows detailed inspection and verification of unoriented wine & juice bottles, canned goods, pharmaceutical vials and other cylindrical packages right on the production line. Using the latest Windows® 7, 64-bit PCs, OmniView® inspects products at up to 1,200 parts per minute without disrupting bottling and packaging lines. OmniView® can help minimise product recalls and protect brand image by ensuring product quality, help control process by identifying defects early & track parts through the supply chain by reading labels and codes. It uses four cameras positioned around the conveyor to capture views of all sides of a product. These images are mapped into a 3D model using proprietary Cognex vision technology, and then inspected using Cognex’s VisionPro® software library. An additional fifth camera can be used to confirm that the lid or cap matches the label on the front of the package. “Version 5.0 of OmniView® dramatically increases the vision & ID applications that can be solved with expanded colour functionality and higher resolution options,” said Didier Lacroix, Senior Vice President, International Sales OmniView® & Services, Cognex. 28 Modern Pharmaceuticals

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Researchers from North Carolina State University (NCSU, Raleigh) recently used a laser-based rapid prototyping approach to create microneedles of varying lengths and shapes, based on two-photon polymerisation of an acrylatebased polymer. This enabled the fabrication of hollow, plastic microneedles with specific design characteristics. These were then used to deliver the quantum dots, which are nanoscale-sized semiconductor crystal dyes with unique properties in terms of light emission that hold promise as a powerful tool in medical diagnosis and theranostics-based clinical applications. The researchers tested the plastic microneedle delivery system using pig skin, as it has characteristics that closely resemble human skin. Using a water-based solution containing the quantum dots, the researchers were able to capture images of the dots entering the skin by using multiphoton microscopy. The images allowed the researchers to verify the effectiveness of the microneedles as a delivery mechanism. Lead author Professor Roger Narayan, Department of Biomedical Engineering, said, “Our findings are significant, in part, because this technology will potentially enable researchers in delivering quantum dots to deeper layers of skin. That could be useful for the diagnosis and treatment of skin cancers, among other conditions.”


MPh (December_2010) 1Tab-29


MPh (December_2010) 1Tab-30


TECH UPDATES

Malvern discusses complementary techniques for OINDP analysis at DDL 21

Thermo Fisher Scientific launches CVCs to streamline performance verification

At this year’s Drug Delivery to the Lungs conference (DDL21) to be held in December (Edinburgh, Scotland), specialists from Malvern Instruments are to present a scientific poster ‘Characterising a nasal spray formulation from droplet to API (Active Pharmaceutica lIngredient) particle size’, which examines the complementarity of automated image analysis and laser diffraction for characterising Orally Inhaled and Nasal Drug Products (OINDP). Nasal spray deposition relates to the droplet size that is delivered while bioavailability depends on several factors, significant among which is the size distribution of the API. Laser diffraction analysis using Malvern’s Spraytec system enables monitoring changes in droplet size, and can be used to investigate the robustness of the delivery system. Image analysis with Malvern’s Morphologi G3-ID, which integrates automated size/shape analysis of particles with the chemical identification provided by Raman spectroscopy, permits detection of even subtle changes in API size distribution. These two highly complementary techniques have applications for various inhaled products. Dry powder inhaler development, which demands detailed study of the dynamics of powder entrainment and dispersion, as well as an understanding of the Morphologi (left) and Spraytec structure of the delivered particles, systems from Malvern offers another example. Instruments

Thermo Fisher Scientific, Inc, the world leader in serving science, has recently launched its new Calibration Validation Carousel (CVC) accessories for the Evolution series UV-Visible spectrophotometers, which enable automated performance verification and adherence to pharmaceutical guidelines. Automated performance verification saves significant time and money by reducing the amount of hands-on time required to complete instrument qualification & testing. Operator hands-on time is reduced to only a few minutes, dramatically improving productivity. All of the Thermo Scientific CVC accessories automate testing for wavelength accuracy & reproducibility, photometric accuracy, resolution, stray light, photometric noise and baseline flatness in accordance with the US or European pharmacopoeia and GxP procedures. The CVC has specific features to increase accuracy and reduce operation time. Each CVC is supplied with its own unique serial number matched to a data file containing the calibrated value of the standards and the instrument specifications. This feature reduces the potential for transcription and calculation errors by eliminating the need to copy standard values, perform & validate calculations and analyse performance test data.

MRI tracking of transplanted stem cells with gadolinium nanotubes The highly toxic rare earth element gadolinium is used in a chelated form as a contrast reagent for Magnetic Resonance Imaging (MRI). A recent study has carried this use of gadolinium a step ahead by sequestering gadolinium in carbon nanotubes. The resulting microscopic tubes are called ‘gadonanotubes’. The investigators at Rice University (Houston, TX) have used these gadonanotubes to label pig bone marrow-derived Mesenchymal Stem Cells (MSCs). Author Dr Lon Wilson, Professor - Chemistry, Rice University, stated, “Until now, there was no effective way to track the cells within the body after these are delivered to the heart, and to test their effectiveness while they are in the heart.” The researchers reported that images produced using gadonanotubes were approximately 40 times brighter and clearer than conventional MRI images. In particular, the nanotubes readily entered and became concentrated in abnormal tissue. This level of sensitivity is such that it will allow tracking of labelled cells inside the body of a patient. The magnetic properties of gadolinium will allow the clinician to guide the nanoparticle-labelled cells to precise locations where they can be deposited and are allowed to grow & differentiate.

Laboratory-engineered miniature human liver Researchers at Institute for Regenerative Medicine, Wake Forest University Baptist Medical Center, have successfully grown replacement livers in laboratory. They are the first to use human liver cells to engineer effectively miniature livers that function similar to human livers in a laboratory environment. “We are excited about the possibilities this research presents, but must stress that we are at an early stage and many technical hurdles must be overcome before it could benefit patients,” said Dr Shay Soker, Professor - Regenerative Medicine, & Project Director, Institute for Regenerative Medicine, Wake Forest University Baptist Medical Center (Winston-Salem, NC). Scientists used decellularised cells from animal livers that replaced the original cells with two types of human cells – immature liver cells (progenitors) and endothelial cells. These cells were introduced into the liver skeleton through a large vessel that feeds a system of smaller vessels in the liver. This network of vessels remains intact after the decellularisation process. The liver was then positioned in a bioreactor, and after a week, the scientists documented progressive formation of human liver tissue as well as liver-associated function. They observed extensive cell growth in the bioengineered organ.

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IN DIALOGUE

‘With easy availability of scientific manpower, India will soon become a dominant player in the international market’ ‌says Srikant Kumar Jena, Union Minister of State for Chemicals and Fertilizers. He provides an overview of the Indian pharma, highlighting the R&D structure, education scenario in India and future of the industry, in a candid conversation, with Chandreyee Bhaumik. r views industry?

on

Indian

ndustry is one of the leading country. The industry enables cturing and technological is required for the production ines. It also meets the domestic obal demands for bulk drugs, rmulations, chemicals, capsules, bles and oral dosages. It is witnessing a healthy growth. In enario, compulsory licensing is essential aspect. It is a required ep for enhancing the growth potential of this industry.

What is the importance of R&D in pharma industry? Strong and sound R&D process forms the foundation of any industry. With R&D, innovation is at hand of the industry. However, we are lacking in this area. It is only the private layers who are dominating this arena. But on the other nd, it is true that no matter ow much we invest in R&D, t is insufficient and appears ess. Thus, we are collating all efforts and investment to make this a successful & prosperous affair.

What has been the progress in the pharma education system in India? Pharma industry is now witnessing a brighter future. To cater to this,

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quality pharma education is a must. The syllabus should encompass even the minutest details related to the entire pharma industry. It should be designed in such a way that it helps students on the technicalities of production and manufacturing, laboratory testing, etc. The syllabus should also impart students with a sound knowledge on the identification, preservation, combination, analysis and standardisation of drugs along with the manufacturing of several dosage forms (tablets, capsules, liquids, powders, ointments, injections, etc). The education imparted to the students should also focus on quality control, research & clinical trials, indications & contra-indications of drugs, and concepts like pharmacodynamics, toxicology and pharmacokinetics. Thus, in order to improve the education system in India, several educational facilities are being established. Apart from National Institute of Pharmaceutical Education and Research (NIPER) at Mohali, there are six other NIPERs already present in India that aim to look into this situation.

How would you forecast Indian pharma industry over the next five years? The Indian pharma industry along with MNCs operating out of India has got a tremendous growth potential. With the easy availability of scientific manpower, India will soon become a dominant player in the international market. This will bring us an added incentive, as we continue to supply to the global markets, thereby increasing our quality standards. Besides, the pharma industry is sure to become self-efficient and technologically strong, thanks to the investments in the R&D segment. As we manufacture drugs locally, the cost of production of these drugs will also be reduced. The future of the pharma industry lies in the extremely rich talent and resource pool. Hence, the pharma industry, with its rich scientific talents and research capabilities, supported by Intellectual Property Protection regime is well set to take on the international market.


LE ADERS SPEAK

‘The vaccine market depends heavily on government purchases’ ...says K V Balasubramaniam, who has been associated with Indian Immunologicals Ltd (IIL) since 1996. His association with IIL is marked by a paradigm shift in making it a limited company in 2000. This was followed by a series of developments ranging from rapid turnaround in profitability to becoming the leading animal vaccine manufacturer in India as well as a leading vaccine exporter. Balasubramaniam shares his journey with Dr Asma Mohd Yousuf. Kindly brief us on the developments undertaken at IIL since its establishment in 1983. IIL was established in 1982 by National Dairy Development Board (NDDB) as a part of the ‘Operation Flood’ programme. IIL began its operations with the Foot and Mouth disease (FMD) vaccine and, subsequently, extended its product portfolio to other

animal & human vaccines. The first plant was set up at Hyderabad for manufacturing FMD vaccine, with a capacity of 25 million quadrivalent doses. This was done in collaboration with Wellcome Foundation, UK. With the introduction of IIL’s FMD vaccine in the market, the prices of FMD vaccines fell to about one-third the price of vaccines manufactured by Multinational mpanies (MNCs). Today, IIL is one of the top three producers of FMD vaccine in the world, with a capacity of nearly 50 million trivalent doses. ubsequently, IIL diversified to manufacturing other terinary vaccines d formulations, as veterinary vaccine, HSemorrhagic a and )

vaccine, theileriosis vaccine, sheep vaccines and nimesulide injection. In 2000, IIL ventured into human vaccines,after a request from the Indian Government to produce anti-rabies vaccine, as it wanted to phase out the old, unsafe sheep brain vaccine. In 2004-05, IIL introduced other human vaccines such as hepatitis B vaccine, measles vaccine, Tetanus Toxoid (TT) vaccine and Measles-Mumps-Rubella (MMR) vaccine. Further, IIL ventured into animal breeding through formation of IndiaGen. Today, IIL is a leader in animal vaccines in the domestic market and a leading player in the human vaccine segment. IIL posted a sales turnover of ` 271 crore in 2009-10, representing a growth of 21 per cent over the previous year. IIL is also among the top three animal health companies in India, with a comprehensive range of animal vaccines, animal health formulations and nutraceuticals.

How has been your experience with IIL? The journey so far has been working assiduously towards IIL’s mission of making ‘Biotechnology in healthcare affordable and accessible’. We have achieved this by scaling up manufacturing capacities, constantly upgrading the technologies, keeping the costs low, introducing innovative vaccines & other products in line with customer needs and developing unique distribution channels to make our products & services available in micro interiors. This process has had its shares of ups and downs. On one hand, timely

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LEADERS SPEAK

Past, present and future I belong to a middle-class family from Palghat, Kerala, that emphasised on education along with character and moral values. I owe a lot to my father, who had humble beginnings, but led a life of character not compromising on basic principles in life. After completing my engineering degree, with Honours in Mechanical Engineering, from National Institute of Technology (NIT), Tiruchirapalli, in 1979, I went on to complete my Masters in Management from Indian Institute of Management (IIM), Ahmedabad, in 1981. I have recently completed a diploma in Patents Law from Nalsar University of Law. I have been in this industry since 1985, ie, for over 25 years. In 1984, I worked as a consultant on a Vitamin B12 manufacturing modernisation project for Merck Sharpe & Dohme (as it was called then). Subsequently, I was hired when Tata took over the company and named it Merind. I successfully implemented the project. In 1996, I was deputed by Tata at IIL for a Joint Venture (JV), but this deal was cancelled. NDDB then gave me the option to stay back, and I chose to continue working with IIL. I have been a part of NDDB’s mission to make a difference in the lives of people in India, particularly the farmers, and I will continue this way. expansion of its FMD vaccine production capacity helped IIL become a leading vaccine player in the country, and its entry in the human vaccine market helped IIL become a human vaccine major in a relatively short time. On the other hand, IIL had to struggle a lot, as it is in a competitive vaccine business – more so, when an Indian company aspires to be a leading international player. Nevertheless, steadfastness in the pursuit of its mission has helped IIL surmount these obstacles.

How is the Indian vaccine industry placed in the global scenario? What are the challenges that this industry faces and how is it armed to tackle the same? Prior to 2000, vaccines were generally regarded as a commodity market with limited revenue opportunities. However, advances in vaccine technology, launch of new vaccines, increased investment in research, change in the public opinion on vaccination, etc, have been successful growth drivers for vaccine companies. Additionally, an improved understanding of the pathogen biology and human immune system along with the emergence of novel vaccine technologies has enabled the development of new vaccines for new indications with a high unmet need.

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The vaccine market worldwide is estimated to be $ 25 billion. However, this market is dominated by five large global companies that control nearly 80 per cent of this market. These companies according to IMS Health are Sanofi Pasteur, Merck & Co, GlaxoSmithKline, Pfizer (following the 2009 acquisition of Wyeth) and Novartis (following the 2005 acquisition of Chiron). This oligopoly in the market exists, as the smaller players usually have limited manufacturing capacity and lack the necessary resources to facilitate large clinical studies & effective distribution networks required for vaccine development. The Indian domestic vaccine industry in comparison is only $ 0.4 billion. This represents about 16 per cent of the Asian vaccine industry. India is one of the leading ‘emerging market’ economies that has witnessed significant economic growth, and is now poised to do even better. Currently, the vaccine industry in India looks as vibrant as the pharma market in India, which has a strong global presence. However, almost till the end of the last century, the focus was on the low-end paediatric vaccines. India entered in recombinant technologies in the mid 90s with indigenous production of the recombinant hepatitis vaccine. Thereafter, attempts to introduce new

December 2010

vaccines followed the development course set by Western manufacturers with glycoconjugate vaccines for Haemophilus influenzae type B (Hib), meningitis and rotavirus. The factors that led to these developments were largely commercial in nature as in India, the National Immunisation Programme (NIP) covered only six childhood diseases, until recently, ie, from 2007, the seventh vaccine dose for hepatitis B is added. This meant that there was a large private market waiting to be tapped. The success of hepatitis B in the private market also bolstered the efforts of manufacturers to look at new vaccines for the private market. With the advent of combination vaccines in the West in the early 90s and their wider acceptance, it was also logical for Indian manufacturers to introduce these vaccines in Indian market. Thus, in the period from the mid 90s till 2010, a number of vaccine manufacturers embarked on both selfdevelopment and research partnerships to bring new vaccines & combination vaccines to the Indian market.

How is the state of R&D in India? What percentage of your company revenues are reinvested into R&D? There exist capabilities for low-cost manufacturers of both conventional and recombinant vaccines in India. However, developing vaccines in India require access to new technologies. Besides, the key challenges are addressing research capabilities, identifying appropriate technologies and sourcing talent, which is scarce. Another issue is addressing the regulatory aspect, particularly the Intellectual Property Rights (IPR) landscape. There needs to be a line drawn between IP protection and global social good by IPR on vaccines & essential drugs. In the past, Indian manufacturers were trying to catch up with their Western peers and were led by the United Nations Children’s Fund (UNICEF) opportunities, which was large and technology to do this was within reach.


LE ADERS SPEAK

Successful initiatives undertaken by IIL v Mission of making biotechnology in healthcare affordable and accessible, which has led to the introduction of our ‘service products’, which are for farm economy available at affordable cost v ‘Operation Pratirodh Programme’, where a network of franchisee doctors dispense quality animal healthcare and breeding services at affordable cost to livestock owners in micro interiors v ‘Operation Abhay’, in which a network of franchisee doctors or ‘Abhay Clinics’ treat patients with animal bites across the country at affordable cost v Introduction of research-based unique animal nutraceutical products, eg, Goudhara Shakti (bypass protein), Calsagar (calcium and phosphorus supplement with herbal supplements), mineral mixtures based on regional mineral mapping, etc v A strong pipeline of new products, eg, Bruvax RB51, Bluetongue vaccine, pentavalent vaccine, Japanese encephalitis vaccine, etc Consequently, the focus on research was low. For instance, UNICEF did not procure the DTaP, a combination vaccine for diphtheria, tetanus and pertussis with acellular pertussis component. As a result, Indian manufacturers did not feel the need to develop one and have, till date, not brought such a vaccine even to the private market in India. The success of recombinant hepatitis B and the successful introduction of combination vaccines have led Indian vaccine manufacturers to embark on conducting their own R&D programmes to develop new recombinant vaccines and explore new technologies to address the need for developing vaccines for tropical diseases. IIL has invested heavily in biotech R&D in the past decade. It spends about 5 per cent of its sales on research in its dedicated R&D facility employing about 60 scientists.

What is your area of concentration and how do you plan to tap the Indian as well as global market? IIL will remain focussed on animal health, animal nutrition, bovine breeding services and human biologicals. The domestic market will continue to remain as IIL’s priority, where it will continue to make essential vaccines and breeding services affordable to common man. The thrust of its international forays would be on qualifying for supplies to UNICEF, catering to the huge rabies

vaccine market worldwide, and supplying animal vaccines to countries with similar disease prevalence.

How much has the company invested in the last five years and what will be your strategy for future growth? IIL earns about 10 per cent of its sales as profits and reinvests about 20 per cent on the capital investments made. IIL has invested about ` 110 crore in the last five years. In future, our key growth drivers would be introduction of new vaccines, qualifying for UNICEF supplies, expanding capacities of vaccine production (eg, FMD vaccine, brucellosis vaccine, measles vaccine, etc), expanding retail presence through nutraceuticals & animal breeding services as well as the Raksha Veterinary Centres (RVetCs).

How does your product pipeline look like? IIL’s new research products in the pipeline are based on recombinant technology. These are the world’s first DNA rabies veterinary vaccine, Brucellosis RB51 vaccine, recombinant vaccine for ticks, Bluetongue vaccine, pentavalent vaccine (DPT+hepatitis B+HiB), Japanese encephalitis vaccine, hepatitis A, chikungunya vaccine, etc. The launch of these vaccines is expected to change the face of the Indian vaccine industry.

What are the challenges faced by your company and how do you plan to tackle them? The vaccine market depends heavily on government purchases. This institutional business is driven more by cost than quality or innovation. The smaller retail market is growing, but is scattered into many emerging product segments. Challenges in catering to this retail segment are the long pipeline of new products as well as logistics of cold chain delivery system. On the regulatory side, the Indian vaccine industry is confronted by a host of issues. At the macro level, the issue is selection of right vaccines to focus on, based on the inadequate disease burden data in our country. Another issue is multiple set of regulations and regulators in operation in the country, such as involvement of Central & State Governments in licensing & inspection. Ethical considerations and impact on environment in matters relating to bio-transformations & biotechnology also add to the confusion. Growing complexity of clinical trials and the need to carry out trial in diverse demographical settings, as well as a requirement that clinical material be produced from the intended manufacturing site significantly add to the costs of development. Further, increasing complexity of Good Manufacturing Practices (GMP) requirements to be met, sometimes more than technically mandated, increases the manufacturing cost. Under the changing economic conditions, the challenge is to keep manufacturing as lean and costeffective as possible, especially on overheads, refining processes for better yields, adoption of industry best practices, reduction of wastage in production and testing.

Where do you see IIL a decade from now? The private vaccine retail market is growing briskly. IIL is expected to emerge as a strong international player, with WHO prequalification of its vaccines. The animal health and breeding services are areas where the government initiative is shrinking. Soon, IIL will step in to supplement the existing infrastructure.

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ROUNDTABL E

Banned drugs available in India

Time to revisit regulatory norms? In spite of several regulations imposed by the Central Drugs Standard Control Organization (CDSCO), the drugs that are banned in the international market have assumed a considerable marketshare in India. In this regard, Meghna Mukherjee presents here some expert views on its implications and remedial measures. There is still a debate that drugs banned overseas are being sold in India.The Organisation of Economic Co-operation and Development (OECD), founded in 1961, helps stimulate economic progress and world trade. According to its report, about 7.5 per cent of fake drugs supplied across the world have some origin in India, followed by 6 per cent from China and 7 per cent from Egypt. The process of banning a drug in the country requires recommendations from National Pharmacovigilance Advisory Committee (NPAC) on product label amendments, product withdrawals and suspension. Thus, one of the solutions that can be foreseen is an urgent requirement for the CDSCO to establish a state-of-the-art pharmacovigilance system to track & analyse safety information for a marketed drug on a continuous basis and assist the NPAC in taking timely & appropriate decisions on safety-related issues.

Dr Arun Bhatt President, ClinInvent Research The decision to ban a drug depends on the risk-benefit assessment of a marketed drug. The benefits of the efficacy of the drug are usually established in Phase III studies. Post marketing surveillance assures the safety of the drug. However, this includes post marketing safety studies conducted by the company on large patient groups, reporting of Adverse Event (AE) by prescribers & patients to company and/or Regulatory Agency (RA) and Periodic Safety Update Reports (PSUR) from the company to the RA. The RA reviews these reports on regular basis to judge the risk of the drug from other sources, eg, foreign regulatory agencies, World Health Organization (WHO), etc. India does not have a state-of-the-art system for carrying out post marketing surveillance. In many countries, it is mandatory for a doctor to report AEs to the RA. However, in India, there is no regulatory requirement for the doctor to report the same.

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Further, doctors in India are reluctant to report AE out of fear of litigation from the patient and ignorance about the importance of reporting AEs. Also, it is impossible to ban a drug in India unless a directive comes from the Drug Controller General of India (DCGI). In India, the regulatory oversight of post-marketing surveillance is not organised along the lines of developed countries. The United States Food and Drug Administration (USFDA) has a MedWatch programme, which is the ‘FDA Safety Information and Adverse Event Reporting Program’. The medical practitioner or patient can voluntarily report a serious AE, product quality problem, product use error or therapeutic inequivalence/ failure that the doctor/consumer suspects. This can be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. Pharma companies also have to file similar reports to USFDA. The MedWatch reports are continuously analysed for deciding regulatory actions and providing safety alerts to medical practitioners & consumers. Therefore, there is a need to set up MedWatch alongwith a pharmacovigilance system. This can track & analyse safety information of a marketed drug on a continuous basis and assist the agency in taking timely & appropriate decisions on safety issues.


ROUNDTABLE

Dr Prakash V Kawli Former president, Indian Medical Association In 2007, the USFDA had ordered GlaxoSmithKline (GSK) to conduct clinical trials on anti-diabetic drugs like rosiglitazone and pioglitazone to confirm the cardiovascular side effects caused by them. The antidiabetic drug rosiglitazone was considered to induce heart failure more frequently. Besides, there are more drugs like nimesulide, thioridazone, tegasero and phenylpropanolamine that can also induce heart failure. India is a developing country and with the prevalence of several diseases in the country, the investment in R&D is quite low compared to other countries such as the US and the UK. With the growing diseases burden in the country, the manufacturing and sale of banned drugs is on the rise. However, one of the main reasons can be attributed to the

Dr Ramananda S Nadig President, Triesta Sciences (India) Pvt Ltd The drugs banned abroad are still available in India because of the lack of strict regulations by the Indian Drug Authority (IDA). For example, rosiglitazone, an anti-diabetic drug, was introduced in the American market several years back. This drug in the initial stages was found to be benefiting diabetic patients. Later, a study revealed that the drug can cause several cardiac problems in diabetic patients with sodium overload. It was thus immediately banned by the USFDA. Many countries recognised the ban imposed, and the sale of drug came to a halt. However, this drug is still available in India. Again, hydroxyquinoline, an anti-diarrhoeal drug from Japan, was banned about 10-15 years ago in the international market, but it is still being sold in our country. This is because in India there are no relevant studies to prove that this drug may be harmful. Another drug metronidazol was found to cause cancer and was thus banned in the American market. Fixed Dose Combination (FDCs) drugs can also be considered as ‘irrational combination’. These drugs may be harmful since one drug in combination with another may cause adverse effects. One such drug is Chlorostrep, a combination of chloromithenicol and Streptomycin, which is

fact that the regulations over the usage of banned drugs in the country are less stringent. Further, there are many medicines that are sold without the doctor’s prescription, and there is no accountability of the fact that whether these medicines are banned in the country. In order to keep a check on this, the Indian Government has passed a Food Safety and Standard Act but the process still continues. There is lack of awareness among the public in the country on the sale of spurious drugs. However, the demand for these drugs in the market has made it a massive platform for the sale of such drugs. Moreover, a major necessity today is to establish a strict regulation board, which will examine the regulatory norms of the supply of spurious drugs in the country. Another reason for the supply for banned drugs in the country is the lack of accountability on sale of the drugs. This is led by encouragement of self-medication that is one of the prime reasons for spurious drugs being sold in the country. Most of these drugs are Over-The-Counter (OTC) products. Therefore, the need to establish a board, which will investigate this malpractice, is very essential.

still being sold in this country, whereas it has been reported in the international market to be a case of ‘Failure of Therapy’. Internationally banned drugs are either single agents or FDC drugs. Some drugs having serious side-effects are still available in India, causing serious health concerns in the country. The much sold nimesulide is found to cause liver toxicity among patients and is thus banned internationally, but Indian manufacturers of this drug argued with the DCGI, stating that there was no relevant study published in India to prove that the drug was harmful. Some of these drugs or drug combinations are still found in South Asian countries because they serve as dumping grounds for the West. In the absence of a clear policy & a network of pharmacovigilance in India, the problem is rampant and is further compounded by physicians often prescribing these drugs because of lack of awareness & the patient deciding to self-medicate with these drugs available as OTCs. Further, the pharma industry in India is strong but unfortunately severe lobbying takes place that forbids a drug from being banned. Therefore, the need of the hour is to have a strict monitoring system in place that would consider the sideeffects of the drugs, and thereby make a study that would help improve the situation. While the DCGI is aware of the problem and is keen to find a solution, the attempts are not resulting in any foreseeable prompt action. The inspectorate mechanism needs to be strengthened and provided with sufficient power to curb this menace at the retailer and the industry level.

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ROUNDTABL E

Dr Rasika G Bhat Medical Geneticist & Lecturer – Medical Genetics, Institute of Nursing Education, J J Hospital; and Bombay Hospital College of Nursing, Mumbai The rationale behind the continuation of banned drugs is simply beyond logical comprehension. Nimesulide has been banned across the world but still enjoys loyal compliance from druggists, physicians and patients in India. Examples include Tamiflu, common cold medication like phenylpropanolamine, cisapride, etc. Again, rofecoxib in spite of being voluntarily withdrawn by the manufacturers still evades any alert. Drug authorities claim that no drug is banned unless an Adverse Drug Reaction (ADR) is reported. Nimesulide was banned based on ADR reported worldwide according to the WHO Pharmaceutical Newsletter. But, unfortunately, not a single ADR on nimesulide was reported in India. This situation indicates an implication that our population is immune to ADR or that the entire population has inherited a favourable pharmacogenomic make up. Banned drugs in India had a tryst with law, but were favoured at the end. A division bench of the Madras High Court dismissed a Public Interest Litigation petition filed by the Tamil Nadu Health Development Forum, saying that there was no ground for their plea in view of the stand taken by the Centre besides dismissal of a similar petition by the Delhi High Court.

Dr S K Gupta Dean & Managing Director, Institute of Clinical Research India (ICRI) There are more than 50,000 internationally branded formulations available in India for public usage. These preparations contain either single drug or FDC drugs. Last year, Merck announced a worldwide withdrawal of its molecule rofecoxib, marketed as Vioxx. In India, however, the drug was sold with impunity and despite the litigation and warnings of the adverse effect of the drug, it continues to be sold. Recently, on November 12, 2010, the DCGI banned the anti-obesity drug sibutramine, but many are ignorant of the information. Regulators have prohibited the sale of these medicines in the midst of rising concerns that these trigger cardiac complications in patients. But most consumers, including the prescribers, are unaware

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The Forum declined to direct the Central Government to ban the manufacture and sale of nimesulide, a drug prescribed for fever & body pain among children. It also rallied against the Centre’s unfair decision as the drug was banned in the US, Canada, England, Australia and other developed countries on grounds of causing serious side-effects to liver & kidney. The DCGI said that the safety profile of the drug was similar to that of other drugs in its category used for pain and fever. The authority to impose a ban currently lies with the Drugs Technical Advisory Board (DTAB) based on reports issued by an executive committee that examines the harmful effects of the drugs. On identification of an unsafe drug, the government issues a ban order and demands withdrawal of the drug from the market and stockists. The DCGI is responsible for notifying the state drug authorities, chemist associations and manufacturers about the ban on the drug. Following this, inspections are carried out and failure to comply is punishable by revoking licence of the stockists. In practice, enforcement and implementation of any law takes its own time in our country. Pharmacovigilance still remains shrouded in a state of forced infancy. The issues that need to be reformed with immediate effect include establishment of a single centralised collaborative body with power to take independent decisions related to imposing ban or withdrawal of any drug, formulation of strict import laws on active pharmaceutical ingredients and drug intermediates from other countries, implementation of a structured adverse effect reporting protocol and encouraging pharmacovigilance. Medical professionals and pharmacists thus need to be updated with newly reported adverse effects of drugs.

of the ban imposed on these drugs. Due to a virtually ‘absent’ ADR mechanism in the country, drugs like Analgin, cisapride, nimesulide & piperazine and many more banned drugs discarded worldwide due to serious side-effects are still being sold in India. One of the major factors is lack of awareness among the public, prescribers and pharmacists in the country. The demand for these drugs still exists, and that is why they are supplied. Another cause of concern is a large section of the patient population involved in self-medication without any prescription. India does not have a mechanism of banning drugs with immediate effect, unlike in the developed world. Thus, pharma companies and retailers continue to sell these banned drugs on the pretext that it takes time to withdraw all the stocks from the market, and this reflects the state of the poor regulations in the country. The business of production of banned drugs is flourishing in the country, and this is due to the growing population and weak regulations. With the mushrooming of both large- and smallscale pharma industries, there are few provisions for a proper check & control of spurious drugs in the Indian market.


FACILITY VISIT

JB SEZ Pvt Ltd

Building inroads to the pharma world With the advantage of location and SEZ benefits, JB SEZ hopes to make a mark in the pharma industry. With opportunities like tax exemption, come responsibilities to follow several manufacturing norms. Chandreyee Bhaumik analyses its agenda, and the path the SEZ aims to traverse. ar away from the crowd, yet not affected by the connectivity barrier, stands the JB SEZ at Panoli, a Joint Venture (JV) between JB Modi Group and HBS Realtors. Located at a favourable position – a few hours from Mumbai, Ahmedabad, Surat and Vadodara – the facility attracts the cream of the crowd from all corners, making it an industrial hub. With a helping hand extended by CPG Consultants, the internal roads are designed to offer better layout facilities, and thereby enhance marketing. Commenting on the infrastructure and investment required to establish the SEZ, Kayvanna Shah, CEO, JB SEZ Pvt Ltd, avers, “We have invested ` 300 crore for the infrastructure, ranging from roads, walls, water plants, power, sales offices and many other miscellaneous projects.” The proposed SEZ is specifically for exports manufacturing of pharmaceutical finished formulations, Active Pharmaceutical Ingredients (APIs) & their intermediates and services related to Research & Development (R&D) and contract manufacturing. The SEZ will have a processing area (10,75,600.69 sqm) for bulk drugs industries, intermediates, formulation industries, R&D facilities and gas-based captive power plant. The nonprocessing area (1,89,811.89 sq m) will comprise a school, hospital, hotel, restaurant, shops, and residential accommodation (200 flats), etc.

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Why SEZ? Any SEZ policy provides developers & enterprises a favourable and lucrative framework of incentives & benefits. Thus, JB SEZ reaps 100 per cent Income Tax exemption on export income

Site plan of JB SEZ

under Section 10AA of the Income Tax Act for the first 5 years, 50 per cent for the next 5 years, and 50 per cent of the ploughed back export profit for the subsequent 5 years. There would also be an in-house clearance for export and import cargo. Further, the SEZ benefits exemption from Central Sales Tax and Service Tax. Elaborating on the advantages, Shah reiterates, “Exemption from Customs & Central Excise duties on import of capital goods, raw materials, consumables, spares and many more are obtainable. Also, there will be exemption from duties on import/ procurement of goods for the development, operation and maintenance of SEZ.” He asserts that this establishment will have all advantages that an SEZ enjoys.

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FACILITY VISIT

Kayvanna Shah Chief Executive Officer

Most of the SEZs operating in our country are based outside Hyderabad. Thus, the companies from northern part of the country think twice before going south. Our geographical positioning, which is well-connected by roadways and railways, stands at an advantageous location. Further, the Panoli railway station touches our SEZ boundary.

The set up JB SEZ is spread over 312 acre, divided into 30-40 plots of varied sizes. Different sizes of land parcels range from 2.5 acre to 30-35 acre for setting up manufacturing plants. Elaborating on the structure, Shah highlights, “This structure is formulated so that there is enough scope for future expansion.” However, he disagrees to divulge the names of the companies that would form a part of this venture. He further continues, “The names of the companies are confidential. These companies are in the area of manufacturing of tablets, capsules or ointments.”

Despite planning big, what hinders the process of realisation of many such projects is the availability of finance. However, for JB SEZ, this was never an obstacle. Shah avers, “The bankers, especially State Bank of India and others such as Syndicate Bank, Axis Bank, have well co-coordinated with us, so that our dream will be fulfilled.”

The recyclable solid waste will be handed over to the authorised vendors for recovery of recyclable material and biodegradable waste that will be composted at the site for organic manure.

Bagging with positivity The SEZ is based at a strategic location too. Claims Shah, “Most of the SEZs operating in our country are based outside Hyderabad. Thus, the companies from northern part of the country think twice before going south. Our geographical positioning, which is well-connected by roadways and railways, stands at an advantageous location. Further, the Panoli railway station touches our SEZ boundary.” Locational benefits enable the availability of low-cost labour, power and water. Opines Shah, “Our economic growth is stipulated by the resources that we can avail. Also, the R&D centres help in enhancing the manufacturing facilities. We can utilise the expertise in API, bulk drugs and many others. In a nutshell, we are planning to give an international look and feel to the project.”

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Abiding by norms The SEZ will abide by the manufacturing norms and regulations set by US Food and Drug Administration (USFDA). Speaking about the importance of energy conservation, Shah explains, “We need to ensure that solar lighting is available. Reservoirs, rain water harvesting and storm water drainage system are also essential during the process.” He further continues, “We are looking at the feasibility. In the SEZ, there are service corridors that function as the utility ducts. For security purposes, we have ensured that there is a gate house and compound wall.” Facilities like street lighting, signboards, common

December 2010

security & surveillance, customs office and bus & truck terminals will be available inside the facility. It will also be equipped with a central fire protection service. The domestic sewage will be treated in two plants of 1,600 cu m/day capacity. Also, the wastewater generated from the processing area will be further treated by the industries to the required standards before discharging to common conveyance channel, which will be connected to the common effluent treatment plant (capacity – 2,500 m3/day). Shah elaborates, “The treated wastewater, conforming to prescribed standards, along with industrial effluents from other industrial units, shall be discharged into GIDC drains. Also, the hazardous and nonhazardous solid waste that include off-spec, obsolete raw materials or products, reaction residues, used chemical reagents, dust from filtration or air pollution control equipment will be sent for further processing.” Explaining on how the SEZ plans to re-utilise the waste, Shah further adds, “The recyclable solid waste will be handed over to the authorised vendors for recovery of recyclable material and biodegradable waste that will be composted at the site for organic manure.” While reaching goals and meeting the targets are important motives of JB SEZ, accountability towards the environment is not forgotten. Thus, the SEZ strictly follows landscaping and sees that there are water-affluent discharges. Like any grand venture, much has been pledged and promised. And, time will tell how these would be fulfilled. In this regard, Shah concludes, “For a pharma enterprise, location is an important consideration. Thus, with geographical advantage, we plan to attract numerous pharma companies in this project.”


SEZ FOCUS

Tax concessions by the government combined with an ideal geographical location make Baddi, Himachal Pradesh, ‘the destination’ for pharma manufacturing. However, poor retention of skilled manpower along with frequent power cuts in the region remains a challenge. A Public-Private-Partnership (PPP) approach seems to be the answer to this issue. Here is a sneak peek into Baddi.

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SEZ FOCUS

Baddi SEZ

Making the right moves? Realising the need for creating an industrial climate conducive for growth, the Government of Himachal Pradesh has taken proactive steps to ensure adequate and faster development of the state. Here is a synopsis of the measures taken to accelerate industrial and other

Photo by: Joshua Navalkar

developments at Baddi – the industrial hub of Himachal Pradesh. The condition laid down for these incentives was that at least 70 per cent of the workforce at these units would have to be local.

Costs of business Here, the cost of land is largely dependent upon the location. Moreover the land adjoining the main road is substantially more expensive. Land cost is approximately $ 35-60 per sq m, and cost of office space is $ 8-10 per sq m per month (on a rental basis). Besides, the cost of power supply for small and medium industries is about 6.8 cent/KWh, while that for large industries is 5.3 cent/KWh.

Hitesh D Gajaria

Facilities at Baddi he Baddi-Nalagarh-Barotiwala belt was designated as a Special Economic Zone (SEZ) in 2003, by the Government of Himachal Pradesh to promote investments in production facilities and generate substantial local employment. Several financial and tax incentives announced at that time are as follows: v Exemption from payment of excise duty (presently 16.36 per cent) on all products manufactured at new units set up here v A 100 per cent exemption from payment of income tax for the first five years and 30 per cent exemption for the subsequent five years v Capital investment subsidy of 15 per cent on plant and machinery subject to a ceiling of ` 3 million v Adequate allotment of low-cost land and faster clearances from all government departments v Creation of the necessary basic infrastructure

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An export promotion industrial park, with an investment of $ 47 million, has been developed at Baddi by the Union Ministry of Commerce. An Inland Container Depot (ICD) is being set up for the benefit of exporting units. At this depot, the export goods will be cleared by the Customs Department and sent directly to the destination without further opening the containers, thus reducing the cost & time involved.

Key industries Some of the industries operating at Baddi include the following: v Pharmaceuticals v Biotechnology v Agro procurement v Floriculture v Industry based on herbal and medical plants v Tea v Forest-based industry v Information Technology (IT) & IT-Enabled Services (ITES) v Construction v Cement


SEZ FOCUS

More than 100 packaging units have set up facilities at Baddi. Some of the larger ones include Essel Propack, Hindustan Tin Works, Jauss Polymers, Borkar Packaging, Baddi Print Pack, Best Packaging and Janus Packaging by virtue of their supplying agreements with their Fast Moving Consumer Goods (FMCG) counterparts, so that they can source duty-exempt packaging materials from a nearby location.

Why Baddi for pharma? Some of the major pharma companies, including Ranbaxy Laboratories, GSK Pharmaceuticals, Cadila Pharmaceutical, Torrent Pharmaceuticals, Alembic Pharmaceuticals, Panacea Biotec, Sun Pharma, Dr Reddy’s Laboratories, Piramal Healthcare, Wockhardt and Zydus Cadila have set up manufacturing units at Baddi. The Government has allowed drug makers to use facilities at laboratories of National Institute of Pharmaceutical Education and Research (NIPER). This is an autonomous Chandigarh-based institute under the Ministry of Chemicals and Fertilizers, and is of great advantage to drug makers in the Small and Medium Enterprise (SME) segment. It is estimated that more than 5,000 SMEs are likely to benefit from the proposal. SMEs do not have full-fledged equipment and testing facilities at Baddi, and hence this move is a major booster for this region. Pharma companies have attracted their packaging counterparts and chemical suppliers to Baddi. The

region has a number of chemicals manufacturing units set up to facilitate growth of the pharma industry. Moreover, direct and indirect tax benefits have strongly stimulated investments in Baddi by the pharma sector.

Pharma companies have attracted their packaging counterparts and chemical suppliers to Baddi. The region has a number of chemicals manufacturing units set up to facilitate growth of the pharma industry. Factors hindering development v Rising costs of real estate: The foremost obstacle is escalation in real estate value in & around the zone, which is hampering more influx of companies and personnel. v Inability to attract outside talent: Due to its geographical location and under-development in terms of infrastructure, there is a problem in attracting talent from outside. Absence of sources of entertainment, good schools, colleges, hospitals, etc, also acts as a deterrent in attracting outsiders to reside in the area.

Major non-pharma units at Baddi v Dharampal Satyapal Group: The group has two plants at Baddi. It is engaged in manufacturing & marketing of a wide variety of products, including, chewing tobacco, food & beverages, hospitality and technology solutions. v Vardhman Group: This is one of the largest textile manufacturing firms in India, with interests in specialised yarns, fabrics, sewing heads and acrylic fibre. The company has a manufacturing facility at Baddi, with an installed capacity of over 80,000 spindles. v Birla Textile Mills (BTM): A division of Chambal Fertilisers and Chemicals Ltd, a flagship company of the K K Birla group, has established a unit at Baddi. v FMCG brands: Hindustan Unilever, Dabur, Colgate Palmolive, Balsara, VVF, Wipro, Bajaj Electricals, Gillette, Cadbury, etc are among the major FMCG brands to set up units at Baddi.

v Infrastructure hiccups: Issues related to communication networks, lack of proper roads and other power & electricity problems still exist here. v Distance from major pharma hubs in the country: Baddi, in Himachal Pradesh, is located quite far from Maharashtra and Gujarat – the corporate offices of major pharma companies in India; hence, commuting becomes quite difficult.

Overcoming the impediments A number of builders (eg, Omaxe, Amaravati, Hill View, Shakun Infrastructure, Mount View group & Sun City) are taking up development projects in Baddi to ramp up infrastructure in the region and also attract outside talent along with further investments. The state government is providing other amenities as well to ensure that Baddi emerges as a convenient hub for investments in the pharma sector. The connectivity to Baddi via all routes is also constantly being improved, to make commuting hassle-free and convenient.

Developments in the offing In spite of the infrastructural hiccups, efforts are being made to build facilities for attracting more investments. The presence of pharma companies across the entire value chain of manufacturing, viz, Active Pharma Ingredient (API), formulations and packaging unit, is another initiative, which will give a further boost to investments at Baddi. Pharma activities are abuzz in Baddi, and with the concessions, facilities and incentives offered by the government to promote development here, the future looks bright. Hitesh Gajaria is the Executive Director at KPMG. He has over 20 years of professional experience in the fields of corporate tax law, direct tax laws, and regulatory issues relating to investments and technology transfer agreements. Email: hgajaria@kpmg.com

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An invite that rewards as well...

Dear Reader, ‘Modern Pharmaceuticals’ 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 3000 words, while that of a product write-up should not exceed 200 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. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will receive a complimentary copy of that particular issue and an honorarium cheque. Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,


REGION OUTLOOK

…more on Baddi

Meeting needs, connecting ends The pharma industry loves the serene environs of Baddi. Not surprising then, that the region has become the pharma hub of the country and the government is equally enthusiastic about this development. But, has this excitement been carried through the years or does the government need a deeper look into the region? Anwesh Koley analyses. addi, in Himachal Pradesh, can well be described as the perfect locale for the pharma sector. Over the years, the region has attracted the attention of a large number of pharma manufacturers, thereby becoming the country’s largest pharma hub with more than 200 companies of different sizes, contributing more than half of the total domestic pharma market. And such an advancement is not without reason. Having constituted the Special Area Development Authority, the government has ensured a comprehensive and regulated development of the Baddi-Barotiwala and Nalagarh planning areas, which together are known as Baddi-Barotiwala-Nalagarh Development Authority (BBNDA). The region was developed in 2003 for the pharma sector, with the aim of developing less developed areas in high-potential states, which would thus help generate employment.

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Banking on location The geographical positioning of Baddi is another advantage for pharma companies that attracts huge labour in the region, as it lies in the lap of the Himalayas as part of the Shivaliks. The government has done a commendable job in encouraging the development of this region. Bodh Raj Sikri, Co-Chairman, Federation of Pharma Enterpreneurs (FOPE), says, “Baddi as an industrial region has a locational advantage, as it is connected with train, road as well as by air up to Chandigarh and Delhi.” Lying along the National Highway, and endowed with scenic beauty, the region offers high potential for planned development in future, since the Himachal Pradesh

Town and Country Planning (HPTCP) Act 1977 was extended to this region in 1985. “Although Baddi comes under a hilly area by definition, in real sense, it is a plain land area, making it more convenient for manufacturers to opt for the place rather than any other location in Himachal Pradesh or Uttarakhand,” believes Sikri.

Destination for investments Baddi came to light in 2002 as a preferred destination for pharma companies, with the announcement of tax and central excise concessions. Major attractions for companies include 100 per cent outright excise duty exemption for a period of 10 years from the date of commencement of commercial

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REGION OUTLOOK

Bodh Raj Sikri

The hiccups

Co-Chairman, Federation of Pharma Enterpreneurs (FOPE)

The current scenario is not all that rosy. The region faces problems with certain key requirements, which are mandatory for smooth operation of industrial units. The availability of manpower has become an issue in the region. While there is no dearth of workforce, there is a problem of labour leaving jobs quite frequently. “Minor hikes in pay are enough to lure an individual for changing his job. We are facing this problem both with respect to skilled and unskilled workforce. Moreover, as of now, we do not see any concrete measure to stop this shift in labour,” says Kumar. Airing a similar opinion, Sikri adds, “Availability of manpower – both skilled and unskilled – is a big issue, as employees frequently move from one company to another for the benefit of perks. This has resulted in undue competition among companies to retain workers. As per law, we are supposed to have a minimum of 70 per cent manpower locally, but the industry finds it difficult to manage such high percentage of local manpower, as most of them are unskilled.” Infrastructure, which was once a key element in attracting investment in the region, seems to have fallen apart. “The region has poor road connectivity currently. Although the government repairs the roads every six months, the heavy movement of traffic causes regular damage to the roads. We do not face problems with the availability and timely delivery of raw materials, but facilities like water supply in the region also needs to be taken care of,” feels Kumar. Another area of concern is availability of power. “Slowly and gradually, we have started witnessing power cuts in the region, which were earlier not there. This is because of the expansion of various industries. Power tariff is also a problem. The state has increased power tariffs, which is affecting the health of the pharma industry,” airs Sikri. Currently, there is a requirement for fresh government policies in the state. “Although, initially, when the incentives came, so did the industries to set

Slowly and gradually, we have started witnessing power cuts in the region, which were earlier not there. This is because of the expansion of various industries. Power tariff is also a problem. The state has increased power tariffs, which is affecting the health of the pharma industry.

production, and 100 per cent income tax exemption for an initial period of five years. The companies also get 30 per cent exemption for a further period of five years and capital investment subsidy of 15 per cent on plant & machinery, subject to a ceiling of ` 30 lakh. Sandeep Kumar, Head-Human Resource, Maiden Pharmaceuticals, says, “Although the government is doing its bit, it can do more. The rebate in excise duties is a welcome move and is the primary reason why companies are setting up units in the region.” There is also a capital investment subsidy of 15 per cent on plant and machinery, subject to a ceiling of ` 3 million. “The income tax, excise duty and sales tax subsidy is offered by the Central Government and not State Government. The state Government offers only the capital subsidy up to ` 30 lakh. The main aim of the Central Government was to develop the state in order to generate employment opportunities in comparison to other states,” adds Sikri. These schemes are also available for existing units that plan to expand their facilities. The thrust sectors that have been identified include those producing non-polluting pharma and herbal products. Besides, the State Government has announced a slew of attractive investment schemes, including singlewindow clearance for projects. The Central Government has cleared 3469 industrial proposals till date and intends to successfully to generate around ` 14,097.63 crore worth of

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investment proposal in the region. This will enable 1,32,066 people in the region to get employment. The current State Government, in tandem with the Union Government, has already set up 2,616 industrial units and is providing employment to 36,902 people in the region. The major investors at Baddi include Alkem Laboratories Ltd with a ` 60 crore investment plan for a new formulations

The Central Government has cleared 3469 industrial proposals till date and intends to successfully to generate around ` 14,097.63 crore worth of investment proposal in the region. This will enable 1,32,066 people in the region to get employment. plant; Indoco Remedies with a ` 25 crore tablets, creams & medicated toothpaste facility, Bengaluru-based Bal Pharma with a ` 20 crore tablet and capsule production facility and Unichem Labs with two new plants at an investment of ` 40 and ` 32 crore. Unichem is already operating a betalactam plant at Baddi.

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REGION OUTLOOK

up new units. They faced difficulties in the beginning, but gradually the infrastructure showed a lot of improvement. However, the Central Government is expected to do a lot more now, since the benefits are all withering, particularly in the development of roads, power supply and other community services,� says Sikri. With the gradual increase in the number of companies setting up units in the region, industrial pollution had also been an area of concern. In order to tackle this problem, the government has plans to have a Common Effluent Treatment Plant (CETP) set up for scientific disposal of municipal, sewerage and industrial waste, in order to preserve the environmental credentials of the region. Baddi Infrastructure Ltd has been nominated by the government for collecting, depositing, processing and disposing municipal and industrial pollutants in the industrial belt. The

Major attractions include 100 per cent outright excise duty exemption for a period of 10 years from the date of commencement of commercial production, and 100 per cent income tax exemption for an initial period of five years. firm would be setting up a ` 80 crore effluent treatment plant, which would treat the effluents on a payment basis after approval from the government. The government would enforce only scientific disposal of effluents by big or small units through the common treatment plant.

The total investment would include a sum of about` 50 crore for the CETP, ` 20 crore for roads and the rest for the skill development centre. Of the total amount, ` 60 crore will be granted by the centre while the industry and State Government will contribute the rest. The government also intends to penalise the violators not abiding by these waste and effluent management standards.

Retaining the glitter Baddi has seen good days and the bad ones. While a great location coupled with tremendous response from the government had initially given a huge thrust to the region, especially for the pharma industry, time has eaten into all the earlier glitters. With more and more workforce entering the region, requirements are at an all time high. For the pharma industry not to lose its faith in the region, there is a need for an urgent action for Baddi to be called as the pharma hub of India.

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INDUSTRY UPDATE

Nutraceutical segment

A logical progression for Indian pharma? Today, the metro lifestyle is synonymous with junk foods and carbonated beverages that are replacing vitamins & mineral-enriched vegetables & fruit juices. Thus, with diet lacking nutrients, the need to supplement the deficiency becomes all the more glaring. In this regard, Chandreyee Bhaumik presents the views of some industry experts. be defined as, ‘a food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease’. Thus, nutraceuticals are products that provide health & medicinal benefits, including prevention and treatment of diseases in addition to the basic nutritional value found in foodstuff. Nutraceuticals may range from isolated nutrients & dietary supplements to genetically engineered foods, herbal products and fortified processed foods such as cereals, foods & beverages.

Convergence as a norm

he words, “In wilderness I sense the miracle of life, and behind it our scientific accomplishments fade to trivia,” of Charles E Lindbergh strike a deep chord. True, we are now trying to go back to Mother Earth for deriving benefits. The term ‘nutraceutical’ was coined from ‘nutrition’ and ‘pharmaceutical’ in 1989 by Stephen L DeFelice, MD, Founder & Chairman, Foundation for Innovation in Medicine (FIM), Cranford, NJ. According to DeFelice, nutraceutical can

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According to a report by Cygnus Business Consulting & Research Pvt Ltd, the nutraceuticals market in 2007 was ` 18.75 billion. It was expected to grow at a Compounded Annual Growth Rate (CAGR) of 20 per cent in order to achieve a market size of ` 27 billion in 2009. Commenting on the market size of nutraceuticals, V Srividyaranjini, Research Associate - Chemicals, Materials and Foods, Frost & Sullivan, elaborates, “The total Indian nutraceuticals market size was valued to be ` 57 billion for the year 2009. Further, the market is expected to grow at 1820 per cent in the forthcoming years.” And, the global nutraceuticals market is estimated at $ 120 billion in 2007, growing at a CAGR of 7 per cent. The report also states that the US has been a major market for nutraceuticals, with India and China becoming the fastest growing markets. Vitamins, minerals and nutrients constitute about 85 per cent of the market while antioxidants and anti agents account for 10 per cent. Other segments such as herbal extracts occupy 5 per cent of the market,


INDUSTRY UPDATE

globally. Cygnus has considered nutraceuticals along with functional foods in order to define the total market of nutraceuticals, both global and Indian. Talking about pharma companies’ growing interest in nutraceuticals Pradeep V Joshi, VP - Technical, AngloFrench Drugs & Industries Ltd, avers, “Pharma companies are now adopting nutraceuticals, and the recent trend is a convergence of food manufacturing companies with pharmaceuticals in order to implement the research necessary for drug discovery. It is thus becoming a logical progression for many companies to enter into nutraceuticals market.”

V Srividyaranjini Research Associate - Chemicals, Materials and Foods, Frost & Sullivan

Increasing the number & variety of products in the market enhances consumer familiarity and the rising competition in the market, which encourages investment in Research & Development (R&D), thus producing innovative products with better quality. Pradeep V Joshi VP - Technical, Anglo-French Drugs & Industries Ltd

Pharma companies are now adopting nutraceuticals, and the recent trend is a convergence of food manufacturing companies with pharmaceuticals in order to implement the research necessary for drug discovery.

Market pillars With industrialisation came a gradual but a noticeable change in the standard of living. Lifestyle diseases such as diabetes and cardiovascular problems are now increasing in India. This is mainly due to the sedentary lifestyle and mass consumption of junk foods. In this situation, there is greater consumer awareness towards the nutraceuticals, consequently leading to an increase in the sale of the same. Srividyaranjini offers an interesting take on the market condition. She opines, “The soaring industries have an indirect effect on the nutraceutical market, owing to the fact that a large number of working population in MNCs corporate sectors and those of the middle class are experiencing an increased standard of living, along with a rise in their disposable income, thus creating opportunities for higher value and luxury products such as these.” Elaborating on the market drivers, Dr Mandar Kubal, Consultant - Infectious Diseases and HIV Aids, Infectious Diseases and Pulmonary Care (IDPC), clarifies, “In this case, the driving force is increasing number of aging population, growing desire towards natural products rather than synthetic derivatives along with the constant desire to lead a healthy and productive life.”

Further, the development in the nutraceutical market has also had an impact on the pet food industry where manufacturers are able to identify a variety of substances that could be employed in order to add value to their existing product lines, or to develop new fortified food products. Clarifying this idea, Dr Kubal explains, “Examples are fatty acid compounds for applications in the joint health sector, compounds derived from mushrooms and novel antioxidant substances.” He further adds, “By synthesising the benefits of both food & medicine, nutraceuticals are expanding into a wide range of areas, competing

against basic items such as raw fruits & vegetables and, in some cases, cuttingedge pharmaceuticals.” Elaborating on the reasons for the expanding Indian nutraceutical market, Srividyaranjini reiterates, “Leading companies have always maintained high brand equity, along with their marketing plans. Strategies involving endorsements by high-profile actors and media personalities have been successful in acquiring immense consumer trust & confidence. Thus, the generally non-experimental Indians are now ready to try out the big companies’ products available in the market.” She continues, “Rise in the number & variety

Table 1: Key market restraints ranked in their order of impact (India), 2009 Rank

Restraint

Order of Impact 1-2 years

Order of Impact 3-4 years

Order of Impact 5-7 years

1

Cultural aspects and eating habits

High

High

Medium

2

The price of the product is relatively high

High

Medium

Low

3

Less appeal in rural market

High

Medium

Low

Source: Frost & Sullivan

December 2010

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INDUSTRY UPDATE

Dr Mandar Kubal Consultant - Infectious Diseases and HIV Aids, Infectious Diseases and Pulmonary Care (IDPC)

By synthesising the benefits of both food & medicine, nutraceuticals are expanding into a wide range of areas, competing against basic items such as raw fruits & vegetables and, in some cases, cutting-edge pharmaceuticals.

of products in the market increases consumer familiarity and increased competition in the market, which encourages investment in Research & Development (R&D), producing innovative products with increased quality. Therefore, the nutraceutical market is highly competitive, and in this situation innovation is essential to remain dynamic in the market place.”

Carving a niche Dietary supplements assume a mature market when compared to functional Food and Beverage (F&B) and is valued at ` 35 billion, with an average annual growth rate of 14-15 per cent per annum. Key supplement types prevalent in India are Chyawanprash, vitamins & mineral supplements, protein and herbal supplements. Dabur, Emami, Meyer Organics, Elder Pharma, Cadila Healthcare, Himalaya

Herbals, Parry Nutraceuticals Ltd, Amway, etc are some of the dominant players apart from the mainstream pharma companies. Elaborating on the dietary supplements, Aradhana Dixit, Senior Product Manager, Plethico Pharmaceuticals Ltd, says, “Today, the consumer is looking for products with a scientific back up. The awareness is much more in countries like the US and Canada. In India, dietary supplements are recommended by the medical fraternity and people prefer buying through prescription.” Again, diabetes & cholesterol management food is one segment that has witnessed strong growth in the last few quarters and has witnessed several product launches such as functional rice, low sugar cookies & ice creams, fat-free butter & cheese and functional breakfast cereals. Srividyaranjini asserts, “There are products that work

Table 2: Key market drivers ranked in their order of impact (India), 2009 Rank

Driver

Order of Impact 1-2 years

Order of Impact 3-4 years

Order of Impact 5-7 years

1

Sedentary lifestyle and mass consumption of junk foods

High

High

Medium

2

Growing Indian economy and change in customer requirements accelerate demands

High

Medium

Medium

3

Presence of all major food companies in this market instills trust

High

Medium

Medium

4

Innovation in terms of health ingredient usage

High

High

High

Source: Frost & Sullivan

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towards maintaining biological blood glucose and cholesterol levels. Marico, Zydus Cadila, Amul, Britannia, Kellogg’s, Mohan Meakins and PepsiCo are some of the dominant players in this group.” However, cognitive foods are not well developed in India, with only a handful of products, typically, powdered health beverages that claim to enhance brain development ability. Heinz, GlaxoSmithkine Consumer Healthcare, Hindustan Unilever Ltd, and Dabur are the prominent players in this arena. Discussing the market dynamics, Srividyaranjini clarifies, “Probiotic or digestive foods in India till now were at a nascent stage; however, these have witnessed exceptional growth since the time of their launch. Probiotic foods first entered India with the launch of Amul’s probiotic ice cream following which a number of other companies introduced probiotic dairy products, eg, Mother Dairy, Tamil Nadu Dairy Federation, Nestle, etc.

Respecting the law: Dos and don’ts The regulations of Prevention of Food Adulteration Act did not cover the functional foods, functional ingredients and other dietary ingredients under the food laws. Later, The Food Safety and Standards Act, 2006 (FSSA), that was revised in 2008, included the rules & regulations for products. Further, the definition for nutraceutical in the FSSA was specified under Section 22 (1) as following: v Plants or botanicals (whole or extracts) v Minerals, vitamins, amino acids, enzymes v Substances of animal origin Highlighting the changes, Dr Kubal clarifies, “The segment is relatively deregulated with a wide variety of laws, regulations & norms, which change from time to time and country to country. This makes the process of manufacturing, quality control and marketing difficult.”


INDUSTRY UPDATE

Need to ramp up

Aradhana Dixit

Like any other industry, the nutraceutical industry too needs a revisit. The ingredients that are used in the manufacture of nutraceutical products are usually considered as one of the premium ingredients in the Indian food ingredients market. Thus, to maintain the margin, the marketers are set to increase the prices in line with the ingredients price hike. Thus, Srividyaranjini opines, “In India, people in rural areas perceive nutraceutical food and drink as western food. They also feel that these products are synthetic, and thereby lack nutrition. India houses 72.2 per cent of rural population, and therefore market penetration for such specialised products is a daunting task.” Seconding this thought, Dr Kubal avers, “In the Indian market, due to a large size of rural population still struggling for basic nutrition, this class of product would rather cater to the affluent classes in the metros and tier I cities.” He further adds that the Indian nutraceutical market is ssalmost 1 per cent of the global pool. These products were considered necessary only during periods of illnesses after which they could be discontinued. Due to less number of players in this segment the initial products were costly, which

Senior Product Manager, Plethico Pharmaceuticals Ltd

Today, the consumer is looking for products with a scientific back up. The awareness is much more in countries like the US and Canada. In India, dietary supplements are recommended by the medical fraternity and people prefer buying through prescription. also was against widespread acceptance for these products. Nutrition too is a little understood and practised science in India. There are not many Indian specific Recommended Daily Allowances (RDA) for our population that make production process difficult. However, he is optimistic in his approach. He continues, “Time is changing. India and China both now boast of a strong middle & upper middle class with growing affluence, rising disposable income, increasing awareness and a desire to be at par with their Western counterparts.” Thus, there is a need to adopt certain strategies to witness a brighter vista for the nutraceutical arena. The plans are in the following respect: E-Marketing: Marketing via Internet is one of the popular trends that is followed. In this regard, Dixit

Table 3: Market quantification for key nutraceutical product categories (India), 2009 Product category

Food type

Market size (in `)

Dietary supplements

Functional foods and beverages

Average annual growth rate (in per cent)

affirms, “Creating awareness is essential in growing markets backed by clinical trials. Further, Public Relation (PR), promotional tools like Twitter and Facebook are also emerging that aim to put the matter in place.” R&D: For any industry to assume a considerable dimension, continuous efforts must be made to strengthen the R&D skills. Explaining the need for R&D in this area, Dixit says, “In this respect, R&D works to preserve maximum actives, evolution of cold and dry manufacturing processes. Further, novel ways of consuming like nasal spray, chewable tablets, drops, etc, are also evolving.” Distribution: Interestingly, for the nutraceutical industry to prosper, the distribution techniques must adopt a different approach. Dixit remarks, “In India, since nutraceuticals move on physician’s prescription, the mode of purchase may be chemists/health stores. However, in Western countries, chemist share is being taken up by online sales.

Chyawanprash

3,000 million

19

Road to future growth

Vitamins and minerals supplements

28 billion

~20

Protein supplements

2,500 million

6-7

Herbal supplements

1,200 million

8-10

Srividyaranjini signs off saying, “Nutraceuticals is an emerging market in India and is expected to witness a lot more competition in the form of top rung global players making a foray into the market. Innovation in ingredient & technology is the new trend. As the US and EU markets saturate specifically in categories such as dietary supplements, India will be seen as the road to growth for most global health & wellness players.”

Diabetes management 5,400 million foods

20

Cholesterol management foods

4,800 million

18-20

Cognitive foods

3,000 million

~15

Digestive segment

10 billion

20-25 Source: Frost & Sullivan

December 2010

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MARKET TRENDS

Cosmeceuticals & health

Growing by leaps and bounds With drying pipelines in pharma, companies are increasingly focussing on different segments, like cosmeceuticals and nutraceuticals. Besides, less stringent regulations make it a healthy bet.

Photo by: Mexy Xavier

Geetha Jayaraman takes a look at the cosmeceutical market.

osmeceuticals are the new attraction in the skincare segment. These are topical cosmetic-pharmaceutical hybrids intended to enhance the health and beauty of skin. The concept propounded by Dr Albert Kligman states that “Cosmeceuticals are topical agents that are distributed across a broad spectrum of materials, lying somewhere between pure cosmetics (lipstick & rouge) and pure drugs (antibiotics, corticosteroids, etc). Therefore, these partake both the categories.” Cosmeceuticals are products marketed under cosmetics segment, which have active ingredients with medicinal properties. Across the globe, cosmeceuticals are still largely confined to the skincare sector. And, anti-aging market dominates this segment. This category has an extensive and

c

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ever-expanding range of biologically active ingredients, promising drug-like benefits and a dramatic, rejuvenating effect on the skin. Dr Anuj Saxena, Managing Director, Elder Health Care Ltd, says, “Cosmeceuticals bring about visible changes in the skin by their action on various skin tissues and enzymes. Thus, the efficacy of the products is more guaranteed and believable. These products have mostly proven their effect, thereby making strong claims of efficacy.” He further continues, “Consumers are always interested in maintaining a youthful appearance. Considering that over 560 million people in India are in the age group of 18-35 years, the market is going to boom, as median age increases. Further, this group includes the growing number of women in the workforce, who strive to maintain a youthful and vibrant appearance. Nowadays, even men are concerned about their looks and have started using many beauty products, thus leading to a promising market for men’s beauty products.”

The world of cosmeceuticals India is constantly evolving in terms of beauty treatments, and today’s consumer is aware of his/her beauty needs. R B Mohile, Managing Director, Claims, informs, “For example, Sun Protection Factor (SPF) has become a buzzword, and today everyone knows about its importance. But, about a decade ago, this was not the scenario. The cosmeceuticals market in India is growing and will soon see a substantial growth in the near future. With increasing consumers’ need for maintaining their appearance along with health, there is no looking back for this industry.” He explains, “The consumer seeks products that will stand up to the claim; thus, the needs on the clinical front are also different. One has


MARKET TRENDS

to design a study wherein one can extract the exact product attributes through well-defined but quick clinical methodologies.” As a result of society’s fascination for maintaining a youthful appearance, and the increasing median age of the global population, this market is expanding at rapid pace. Like cosmetics, cosmeceuticals are also topically applied, but they contain ingredients, which influence the biological function of the skin. “Although cosmeceuticals improve appearance, they do so by delivering nutrients necessary for healthy skin,” points out Dr Saxena.

Indian vis-à-vis global market After China, India is the most bio-diverse country. Despite the global economic downturn, India remains one of the fastest-growing beauty markets. It is growing at 13 per cent per annum and valued at $ 6.3 billion. The US is the largest cosmeceuticals market. It touched $ 16 billion (in 2008) and in the next five years, it is expected to reach a buoyant Compounded Annual Growth Rate (CAGR) of 6.7 per cent. Dr Saxena avers, “The global organic cosmetics industry is valued at $ 7 billion. The market offers extensive opportunities for domestic and international players. Despite the recent lull in the global market, these companies have seen an 18 per cent growth this year. Global skincare sales are projected to grow by 25 per cent to reach $ 69.6 billion in 2010 from 2005.” He also adds, “Anti-cellulite body care and anti-aging products will continue to be a key source of dynamism in the longer term. Moreover, the cosmeceuticals market will face intense pricing competition due to the growing market penetration of private label cosmeceuticals brands and the rapid commercialisation of innovative ingredients & products. The Indian market is still in its infancy,

Dr Anuj Saxena Managing Director, Elder Health Care Ltd

Considering that over 560 million people in India are in the age group of 18-35 years, the market is going to boom, as median age increases. Further, this group includes the growing number of women in the workforce, who strive to maintain a youthful and vibrant appearance. and it is too early to calculate the percentage contribution. Currently, the contribution is negligible in the market, as it is still evolving.” Some of the Indian pharma and Fast Moving Consumer Goods (FMCG) companies currently marketing their product lines in India and international markets are Dabur, Emami, Shahnaz, Marico, VLCC, Cavincare, ITC, Cadilla, Cipla, Ranbaxy, Glenmark, etc.

Indian pharma companies in cosmeceuticals The Indian pharma is on the lookout for growth. Specialty segment and focussed field are bringing in new growth opportunities. Mohile says, “The typical Indian consumer who has been traditionally conditioned to consult the doctor for only health-related issues is now also seeking doctor’s advice when it comes to skincare. Added to this is the larger consumer population that wants to look beautiful and younger. Moreover, dermatologists are offering specialised cosmetic services &

products, and patients feel comfortable relying on them.” Cosmeceutically active ingredients are constantly being developed by companies engaged in pharma, biotechnology, natural products & cosmetics, while advances in the field & knowledge of skin biology and pharmacology have more rapidly facilitated the cosmetic industry’s development of novel active compounds. Dr Mukesh Batra, Founder & CMD, Dr Batra’s Clinic, avers, “Consumers need a value proposition. It is no longer health ‘or’ beauty, but is health ‘and’ beauty. Consumers are moving away from a basic need to a specialised need and are willing to pay for the same. Today, a consumer analyses a product not only with the feel good factor, but also seeks one that solves his issues. Skincare products can make a difference to an individual’s appearance, such as skin whitening, anti-ageing treatment and anti-wrinkle creams. Several FMCG companies are now launching premium products like shampoos and skincare

R B Mohile Managing Director, Claims

The cosmeceuticals market in India is growing, and will soon see a substantial growth in the near future. With increasing consumers’ need for maintaining their appearance along with health, there is no looking back for this industry.

December 2010

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MARKET TRENDS

Dr Mukesh Batra Founder & CMD, Dr Batra’s Clinic

Consumers need a value proposition. It is no longer health ‘or’ beauty, but is health ‘and’ beauty. Consumers are moving away from a basic need to a specialised need and are willing to pay for the same.

products. People want themselves and their families to look better & healthier. Thus, with increasing awareness, people are making educated choices on products that they would use.” Dr Saxena elaborates that the desirable features of cosmeceuticals agents are efficacy, safety, formulation stability, novelty & patent protection, metabolism within the skin and inexpensive manufacture. Thus, an attempt has been made to review different types of cosmeceuticals and their regulatory aspects. Cosmeceuticals can be viewed as functional ingredients that affect appearance. The first agent to fall in this category was all-trans retinoic acid, the biologically active form of vitamin A, which is now known to boost the collagen content of the skin.

Product innovation and targeted delivery In the cosmetics area, particularly in the anti-aging category, and the pharma sector, nanotechnology has played an important role in delivering active ingredients to the skin in patch delivery as well as timedrelease application. These make it the right target segment for the Indian pharma industry. Regulations are also comparatively less stringent in this segment. At the same time, international companies have invested in R&D of cosmetic products, and all international brands have been eventually

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developed in their R&D centres largely outside India. Says Mohile, “Indian pharma companies also have facilities for drug development. Thus, they can use the technology for cosmetic

The cosmeceuticals market will face intense pricing competition due to the growing market penetration of private label cosmeceuticals brands and the rapid commercialisation of innovative ingredients & products. The Indian market is still in its infancy, and it is too early to calculate the percentage contribution. development, and thereby compete in the international market. In terms of infrastructure & capabilities, India is not far behind, and we are all geared to face the challenges of cosmetic product development, manufacturing & testing.” He further informs, “Over the past decade, a handful of drugs have found uses in smoothening wrinkles, preventing baldness or shedding unwanted hair. Given the

December 2010

demand from a society obsessed with beauty, one might expect pharma and cosmetics companies to fall over themselves to create a new generation of vanity drugs – or ‘cosmeceuticals’. ”

Into the future The future promises increasingly sophisticated formulations for cosmetics and skincare products. Thus, cosmetic companies are finding ways to deliver small-dose ingredients that do not require medical regulations to introduce steroids and hormones in products, which would help in improving body mass as well as nail & hair growth. Government regulatory agencies will thus face new challenges, as more products with a true biological activity are invented and tested. Dr Saxena avers, “Claim substantiation and premarketing testing must also evolve to accurately assess efficacy & safety issues, with important implications for total body health. The new vehicles and delivery systems combined with established ingredients will alter percutaneous absorption, requiring re-evaluation of substances with an assumed good safety profile. Also, biotechnology will compete directly with the pharma and cosmetic businesses.” The most influential trend over the coming five years will be the links between internal health, beauty and anti-aging. Thus, the next dominant beauty trend will include skingestibles that will promote beauty from the inside-out, borrowing of pharma terms for cosmetic applications, amino peptides to make the skin more elastic, neuromediators that are chemicals to instruct the brain to be happy and thinning boundaries between surgery & cosmetics as well. Dr Saxena concludes, “The trend towards therapeutic cosmetics is sure to result in the need to obtain a better understanding of modern ingredients and assessment techniques.”


RETAIL ZONE

Fraud and shrinkage in pharmacies

Battling the profit killers Today retail shrinkage is a growing problem worldwide. It includes employee crimes, shoplifting and administrative errors that create losses in a business. Thus retailers must take steps to avoid & manage this to minimise retail loss. Here are a few ways to discipline the system to boost profits and ensure a fraud-proof management system. Rajendra Pratap Gupta hrinkage (loss from shoplifting/ employee crimes & administrative errors) and fraud are major headache for retailers across the world. These are the biggest profit killers, and are making retailers worry. Global retail theft totalled $ 107.3 billion in 2010, according to the fourth annual edition of the Global Retail Theft Barometer. Shrink varies according to business type, vertical market and country. In 2010, some of the highest average shrink rates were found in apparel/clothing & fashion/accessories (1.72 per cent), and cosmetics/perfume/beauty supply/pharmacy (1.70 per cent, which is the third highest). Customer theft, including shoplifting and organised retail crime caused the biggest shrink loss in most countries at 42.4 per cent, followed by employee theft at 35.3 per cent. In Asia-Pacific, infant formula and alcohol/ liquor have the highest shrinkage in grocery stores. Fashion/tailored clothing & accessories as well as health & beauty supplies like shaving products, lipsticks and glosses are the key targets of shoplifters. Indian retailers lost ` 9,296 crore to shoplifting and theft, in the year ended June 2010. Shrinkage in India is highest in the world as the percentage of retail sales (2.72 per cent) according to the Global Retail Theft Barometer study. Inventory losses due to shoplifting, employee theft, paperwork errors and supplier fraud could worsen, as Indian retail market moves towards growth. Therefore, given the high-value density items at the pharmacies, it is important to control shrinkage. According to a study by the National Retail Federation and the University of Florida, theft rate

s

as a percentage of sales is about 1.61 per cent of sales. According to the National Retail Federation report, 47 per cent of the total revenue lost was due to employee theft, while shoplifting accounted for about 32 per cent. Administrative errors accounted for 14 per cent, while supplier fraud accounted for 4 per cent. The remaining 3 per cent remains unaccounted for. Another report states that an astonishing 95.2 per cent retailers have experienced goods return as the most popular form of return fraud in the past year. While many retailers are strengthening policies – some at the expense of customer service – the retail industry still looses billions of dollars in return fraud. Fraud, either by customers or by employees, is regular in retail business. It is impossible to eliminate fraud altogether. Hence, the only question is how much can this be minimised. With rising challenges in the sector, the key to success is staying competitive without compromising on the quality of services. Thus, cost-effectiveness is necessary to achieve this,

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RETAIL ZONE

and an effective fraud risk management will help companies identify potential leakage points. Strong internal controls, backed by sound data analytics to mitigate key fraud risks would help detect the fraud cases at early stages. Various categories of fraud constitute a major component of shrinkage. Among the factors responsible for shrinkage losses, employees and vendors are critical factors that need to be managed by retailers. Employees may resort to direct theft, under-invoicing in collusion with customers, stealing cash, etc, whereas vendors can under-deliver in terms of number, size or quality of items as against the bill invoice.

IT-backed fraud

Source: National Retail Research Group, Arizona, USA

A high-tech variant in this category will be a shop assistant who manipulates the computer program so that a portion of sales proceeds is credited to another account while computing the overall profits for the store. This is a difficult activity to detect, as the individual amount siphoned off from each transaction is very low and unless the detection and control activity exhaustively checks all the operational methods. This type of activity continues for years till it is caught and comes to light. The individual(s) runs up a sizable profit and makes a lot of money on

account of the huge & voluminous transactions that run into millions during a year. The following can be considered as a case in point. In a retail pharmacy chain, the individual in charge of sales, who also happened to be a tech graduate, committed fraud for a long time by a

The requirement here is to set up dedicated teams – internal or external – to find the variations by having periodical physical and system stock checks at each store unique methodology. Generally, when any material is sold, the stock quantity automatically changes in the system. This person used to delete the desired invoice having high-value sale, through back office access, and thus changed the record once the material was sold. The effect of the same was that a customer would make a purchase with a bill, and this employee would pocket the cash. Most importantly, the deleted invoice numbers would be reused for other future sales.

50% 48% 40% 36% 30%

Suppliers trick

20% 16% 10%

0%

Some time later, on having doubts while checking the high-value items, the stocks at the front office and back office were matched. The difference in quantity was exactly as in the deleted invoices. Since the invoices had timings of the sales, it was easy to find the executive. On confronting him with the facts, the entire fraud came to light. The point is, one may detect fraud at the time of its occurrence, but there has to be a proper system in place, which will enable in revealing the same. Thus, the requirement here is to set up dedicated teams – internal or external – to find the variations by having periodical physical and system stock checks at each store. The team should be dedicated, which indirectly means that they need to be well taken care of so that they cannot become part of the fraudulent practice. They must have a feeling that there is much to lose than gain. The need is to adopt a proper system for an end-to-end tracking of material movement from the source to destination. This must be accomplished with dedicated internal checks and balances by an independent internal department, which comprises high-powered executives who know the entire policies of the organisation, and are aware of systems related to movements of goods. These executives need to have strong financial background and analytical abilities. It is also advised that the head office take the system-generated report on the changes made in the backend by the administrator, to check if any invoices or entries have been modified. This will result in a fraud-proof management system.

Pharmacy

Liquor

General merchandise

Scenario of shrinkage in a US based chain. Pharmacy accounted for the highest shrinkage

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One of the major areas for good shortage in a pharmacy is the receipt of goods from the central distribution centre and the suppliers (Direct Store Delivery [DSD]). Generally, all suppliers would have the same delivery timing, with mostly being in the evening after 5 pm. This is the time for evening


Source: National Retail Research Group, Arizona, USA

RETAIL ZONE

Counter (OTC) & cosmetics from these shelves. Pricing/ Damage/ Accounting 9%

Vendor/DSD Receiving 16%

Where is the shrink in a pharmacy?

Following steps can prevent or lessen the theft from the front end racks 1. Keep high-value Shoplifting 31% products in glass shelves Employee-caused that are locked shrink 44% 2. Keep a store attendant to ‘service’ the impulse buyers and keep a close eye on front racks 3. Install a close–circuit camera in the pharmacy. Now a days, with low-cost technology available, and broadband Diagram showing shrinkage areas available in all major sales, as most customers return from towns, this is the best option their offices at this time and purchase to keep track of customers and medicines. Hence, the pharmacy staff customer service via remotely has less time to check all the goods and monitored cameras. if at all they do so, they do with utmost reluctance and in a hurry, leading Employees and shrinkage to errors. Suppliers use this trick of Employee-caused shrink is the number evening hours delivery to send less one cause of shrink, contributing to and bill more or to give short supplies 44 per cent of all shrink. Companies can or not supply-free goods or schemes. significantly reduce employee-caused Pharmacies should adopt the following shrink by employing the following five to prevent the shortfall of goods in primary best practices: 1. Pre-employment honesty/integrity receiving supplies: testing along with behaviour-based 1. Identify a fixed slot for receiving interviewing goods (afternoon hours) 2. Dedicate a defined place for 2. Proactive, pre-emptive automated cashier performance monitoring receiving goods 3. Rotate the duty of the personnel 3. Computer-based training modules (that include a shrink prevention receiving the stock to avoid building module) a relationship with the vendor 4. Formal loss prevention programmes Customers - Front end racks 5. Written employee-caused shrink Generally, front end shelves (the racks prosecution policy at the entry of the pharmacy, also Most shoplifters are amateurs. But, there known as impulse buying merchandise) are people who make their living from have small-size high-value items. shoplifting, and they tend to be more Moreover, this place is a little away skilled & professional in committing from the billing counter. There is a fraud. System failures are other important good possibility of theft happening reasons of fraud among employees. Once from these racks, as customers crowd employees have the knowledge of system together at times, and it is easy to loopholes, they try to take advantage conceal small items like Over-The- of the same in a very small way to

begin with. This keeps on increasing at reasonable intervals and grows into major fraud. Another important reason for fraud is the management itself. When the management wants to break the systems at certain occasion for some specific needs and gives power to some of the executives to modify the systems as and when required, the proportion goes beyond the management’s ultimate need and, in turn, results in systematic fraud, against which even the management is unable to take any action. Although it is impossible to eliminate altogether the fraudulent practices & theft, one can definitely ensure that through proper checks and balances, the fraud can be detected & theft averted. One needs to continuously work on to find occurrences of fraud, irrespective of whether it is mom-and-pop stores, or large format stores. There is evidence that of all unknown profit shrink, 74 per cent can be controlled, while 26 per cent are caused by uncontrollable conditions. Until senior executives at the highest levels of the corporation embrace professional, technology-enabled, proven loss prevention practices to combat the 74 per cent of controllable shrink, we will continue to see overall, store-wide shrink reported as a significant percentage of retail sales. Recognising that every rupee of shrink that is saved results in a 100 per cent contribution to bottom-line profit can make shrink recovery a company’s number one profit source. The need of the hour is to be continuously vigilant, as it goes without saying – ‘Money saved is money earned’. (With input from Vijay V Parikh, retail fraud & loss prevention professional)

Rajendra Pratap Gupta is an International Healthcare Expert & Speaker, and is on the board of several companies in the US & India across retail, hospital chains, disease management, pharma R&D, diagnostics and biotechnology, among others. Email: mail@rajendragupta.org

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LEGAL EDGE

Section 3(d) in pharma

Changing rules of the game Section 3(d) of Indian Patent Act states that to file a patent, an invention must show substantial increase in ‘efficacy’ of a substance and not just its new form. But as lawmakers did not clearly define the term ‘efficacy’, many drugmakers began to extend patent term by making claims of trivial changes to the original product.

Anuradha Salhotra ndian pharmaceutical industry is estimated to be the third largest in the world in terms of volume and 14th largest in terms of value of products, being over $ 20 billion. About 50 per cent of revenue comes from export to the developed and the third world countries. Exports have been growing at a rate of 20-25 per cent in the last few years. The Indian pharma industry meets about 70 per cent of domestic demand for intermediates, bulk drugs, formulations, chemicals, tablets, capsules and injections. A study by Federation of Indian Chamber of Commerce and Industry (FICCI)–Ernst & Young India has estimated that MNCs will

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have $ 8 billion marketshare for expensive drugs in $ 20 billion domestic pharma market, by 2015. The Indian pharma industry has been predominantly a generic industry, nurtured by a patent regime, which allowed only process patents. Hence, it was possible to tweak products without infringing any intellectual property rights. However, the introduction of product patents in India in 2005 has changed the rules of game. As there is no bar on continuing to manufacture drugs that are off-patent, the industry can continue to enter into various markets in the same manner as before. However, the in-house drug R&D facilities need substantial upgradation to remain in the reckoning. While drafting the 2005 amendments, Indian lawmakers were fully aware of the malpractice of evergreening adopted by certain pharma companies. These would file new patents claiming new features, use or forms of the same active molecule, which included polymorphs, dosage forms, hydrates, salts, combinations, etc, to perpetuate the patent well beyond the normal term of 20 years.

Amendment in Section 3(d) Article 27 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement mandates that patents shall be available for any inventions whether products or processes in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application, and shall be available and patent rights enjoyable without discrimination as to the place


LEGAL EDGE

of invention, field of technology and whether products are imported or locally produced. Therefore, a product patent that meets the condition of novelty, inventive step and industrial applicability would qualify for the grant of patent in India. With the introduction of product patents, India provided a safety measure to prescribe evergreening of the patents in Section 3, which relates to inventions that are not patentable. Sub section (d) of this section has been amended as follows: “3. What are not inventions – The following are not inventions within the meaning of this Act; (d) The mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere new use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. The Section was amended to include the following phrase: The mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance in the earlier version. And an ‘explanation’ was added under the sub section to define the term ‘new form’ and to explain that the new form of a known substance will be treated as same substance unless they provide significant enhancement in efficacy. Surprisingly, the ‘Explanation’ under sub section 3(d) is worded similar to that in Article 10(2) (b) of Directive

2004/27/EC of the European Union (EU). It reads, “The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in proportion with regard to safety and/or efficiency.” However, the words ‘safety and/or efficiency’ are replaced by ‘efficacy’. Further, the EU directive is in relation to processing of drug marketing approval by the regulatory authority.

Ambiguities galore in Section 3(d) It is interesting to note that lawmakers left the terms ‘efficacy’ and ‘significant’ undefined in the Patents Act. The result was that these terms were interpreted quite subjectively by the Controllers in Indian Patent Office.

The Government should clarify the usage of terms ‘significantly’ and ‘efficacy’, which form a part of Section 3(d), to clear the ambiguities involved in the interpretation of the said section. There is another serious anomaly. Even New Chemical Entities (NCEs) are not immune to Section 3(d), as some controllers may subjectively consider these entities as ‘other derivatives of known substance’ – a phrase loosely used in used in the ‘explanation’ portion of Section 3(d). In the absence of any definition of the term ‘derivatives’ in the Act, the Controllers tend to interpret it as per their own understanding. In chemistry, it is difficult to find compounds that are not derived from a known substance. Thus, almost all NCEs may be considered as mere derivatives and objected under Section 3(d).

Novartis saga M/s Novartis AG had filed a patent application for the beta-crystalline form of Imatinib Mesylate, a pharma substance sold worldwide under the brand name Gleevac/Glivec. A few generic drug manufacturers along with patients’ association filed a representation by way of pre-grant opposition on a number of grounds, the main being Section 3(d). Pursuant to the representation, the Patent Office rejected the application on grounds of Section 3(d), stating that the betacrystalline form of Imatinib Mesylate is the salt of a known substance without an increase in efficacy and, therefore, not an invention under Section 3(d). Novartis approached Madras High Court, through writ petition, challenging the grounds on which the patent was denied, and separately challenging Section 3(d), which according to Novartis contravenes not only TRIPS but also Article 14 of the Indian Constitution, which ensures equality before the law. A two-judge bench while dismissing the writ petition ruled that Section 3(d) was constitutional and cited lack of jurisdiction in deciding whether the provision of the law in question is compatible with TRIPS. The High Court referred the appeal challenging the grounds used by the Assistant Controller in rejecting the patent, to Intellectual Property Appellate Board (IPAB). Novartis filed a writ petition in the Madras High Court to replace S Chandrasekharan, the technical member of IPAB, stating that he was earlier serving as Controller of Patents and Design when Gleevac was refused patent. Later, the Supreme Court, examining the nature of the dispute, appointed Dr P C Chakraborti, Deputy Controller of Patents & Designs, as technical member for the matter. IPAB while rejecting the appeal stated that 30 per cent enhanced bio-availability as claimed by Novartis cannot be considered as enhanced efficacy, as efficacy particularly relates

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LEGAL EDGE

Facts During the last four financial years, only 316 pre-grant oppositions were filed as against 143,963 patent applications published during the same period, which is about 0.22 per cent of published applications. to therapeutic efficiency and Imatinib Mesylate as such and its beta form are therapeutically same substances with regard to efficacy. Novartis then moved Supreme Court, where the matter is still pending.

Glochem vs Cadila Glochem Industries had filed a representation by way of pre-grant opposition against Cadila’s patent application 413/MUM/2003A for clopidogrel besylate. The Patent Office, however, granted the patent. Glochem Industries filed a writ petition in Bombay High Court, challenging the Controller’s order. The Court noted that the Assistant Controller had incorrectly granted the patent, considering reduced toxicity and enhanced stability & shelf life of the claimed product, as these factors do not constitute enhancement of known therapeutic efficacy. The Court set aside the order of the Controller regarding grant of the patent and directed the Controller to consider the arguments of the Petitioner afresh.

Emergency contraceptive pill patent Recently, in a post-grant opposition filed by Cipla, the Indian Patent Office in Mumbai revoked Indian Patent Number 202297 granted to Richter Gedon against the Application Number 1119/MUMNP/2003 (filed on December 09, 2003) for an emergency contraceptive pill containing Levonorgestrel. The Controller found Cipla’s arguments relating to novelty, inventive step and Section 3(d) persuasive.

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Forteo Patent

Mashelkar Committee Report

Consequent to a pre-grant opposition filed by USV, the Indian Patent Office in Kolkata rejected Eli Lilly’s patent application for Forteo, a biotech drug, on grounds of lack of novelty and failure to meet the requirements of enhancement of known efficacy. Forteo is a synthetic form of hormone parathyroid found in the human body. Later, Eli Lilly voluntarily withdrew another application for crystalline form of the same molecule.

Right on the heels of passage of Patent Amendment Bill, 2005, Government of India set up a Technical Expert Group (TEG) on Patent Law Issues on April 5, 2005. The terms of reference for this group, popularly known as Mashelkar Committee, included whether it would be TRIPS compatible to limit the grant of patent for pharma substance to NCE or new medical entity involving one or more inventive steps. In March 2009, the committee submitted its report with the recommendation that, “The TEG concludes that it would not be TRIPS compliant to limit granting of patents for pharma substance to NCEs only, since it prima facie amounts to a ‘statutory exclusion of a field of technology’. However, every effort must be made to provide drugs at affordable prices to the people of India. Further, every effort should be made to prevent the grant of frivolous patents and ‘evergreening’. Detailed guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharma sector so that the remotest possibility of granting frivolous patents is eliminated.” The report further says, “TEG recommends that every effort must be made to prevent the practice of ‘evergreening’ often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product. The Indian patent office has the full authority under law & practice to determine what is patentable and what would constitute only a trivial change with no significant additional improvements or inventive steps involving benefits. Such authority should be used to prevent ‘evergreening’, rather than introduce an arguable concept in the light of ‘statutory exclusion’ of incremental innovations from the scope of patentability.”

Little opposition In spite of very high success rate of oppositions filed on grounds of Section 3(d), the number of Patent oppositions is very low. For example, as per Annual Report of Patent office for 2008-09, a total of 40,749 patent applications were published, whereas only 153 representations by the way of pre-grant opposition were filed in the financial year 2008-09, ie, about 0.25 per cent of total applications published. During the last four financial years, only 316 pre-grant oppositions were filed as against 143,963 patent applications published during the same period, which is about 0.22 per cent of published applications. During the previous year, 71 post-grant oppositions were filed; however, only seven were disposed. The number of pending pre-grant oppositions is 337 and that of post-grant oppositions is 122.

Parliamentary Committee Report

Standing

Department-related parliamentary standing committee on commerce, comprising lawmakers presented its report to the Rajya Sabha (Upper House) on October 24, 2008. The report recommended that, “The Government should clarify the usage of terms ‘significantly’ and ‘efficacy’, which form a part of Section 3(d), to clear the ambiguities involved in the interpretation of the said section. It needs to be ensured that the laws are not TRIPS-plus but just TRIPS compliant.”

December 2010


LEGAL EDGE

Government of India has accepted the recommendations of the TEG on Patent Law. It is to be seen when this acceptance metamorphoses into amendment in the Patents Act.

Lobbying by pharma MNCs Recently, a delegation of Organisation of Pharmaceutical Producers of India (OPPI) represented by Indian units of MNCs including BMS, Novartis, Pfizer and Eli Lilly along with executives of OPPI, a lobby group of international drug innovating companies, visited Prime Minister’s Office (PMO). The PMO circulated a note relating to review of Section 3(d), apparently prepared by OPPI, to the concerned ministries. It appears that in the face of strong opposition by Indian Drug Manufacturers Association, the review is not expected any time soon.

Drafting a pharma patent In view of the provisions of Section 3(d), it is essential to provide in the patent specification, a comparative data of the compound claimed and its known parent compound. The data should clearly indicate enhanced efficacy of the compound when compared with the parent compound. Consequent to the Novartis judgment, the term ‘efficacy’ in Section 3(d) is defined as ‘therapeutic efficacy’ only. As efficacy data is generally not available at the time of filing the application, it is advisable to include some in vitro or in vivo examples, the results of which can support a later submission regarding enhanced efficacy of the claimed compound over its parent. Section 3(d) prohibits ‘new use of a known substance’; therefore, new use of compounds that already exist do not form a patentable subject matter. Accordingly, claims relating to second medical use of a known substance for a new indication, howsoever worded, are not accepted. Section 3(d) is also significant for processing patents, as this Section does not allow mere new use of a known process unless it results in a

new product or employs at least one new reactant. Therefore, the application for process patent should clearly provide enhanced yield and/or purity of the claimed compound as compared to the processes known in art for similar preparations. The statistical data emphasising enhanced efficacy cannot be incorporated later in the specification during prosecution of the application. However, the efficacy data can be provided in a submission along with an ‘Expert’s declaration’ as a showing to support the argument for enhanced efficacy of the claimed compound.

Section 3(d) provides both challenge and opportunity to scientists engaged in research of drugs. The requirements for meeting Section 3(d) can be substantially incorporated in the specification at the time of drafting. A crying need The IPAB in the Novartis judgment ruled that efficacy pertains to therapeutic efficacy. There are various factors related to a pharma product, which determine the quality of drug such as improved shelf life, enhanced bioavailability and stability of a drug, hygroscopic nature of drug, heat resistance, toxicity and side effects. For example, increased bioavailability could ensure that a greater amount of the drug could reach the target site with the same or lesser dosage. This has an advantageous effect, and therefore renders the drug more efficient. It is worth considering by Government of India and the lawmakers whether present interpretation of Section 3(d) will affect the research and innovations on various forms of existing drugs in the long run and

whether Indian scientists will be reluctant to conduct further research on derivatives, salts or other forms of known active compounds.

Tapping future potential Section 3(d) provides both challenge and opportunity to scientists engaged in research of drugs. The requirements for meeting Section 3(d) can be substantially incorporated in the specification at the time of drafting. The teachings in the specification can be subsequently corroborated with expert’s evidence supported by data. MNCs should tap the highly educated and trained scientific manpower in the drug industry in the country to develop new drugs for diseases afflicting the population of the third world countries. In this manner, not only they would drastically reduce cost of development but also gain a huge niche market for their products.

What Section 3(d) defines? Section 3(d) of the Patents Act, 1970, has rendered new forms of known substances not patentable unless they have significantly enhanced efficacy. If clinical data is not available, a teaching of the experiments conducted to show enhancement of efficacy should be incorporated in the patent specification at the time of drafting and can be subsequently corroborated with expert’s evidence supported by available clinical data. Indian lawmakers should consider amending the Patents Act to clearly and unambiguously define the terms ‘significantly’, ‘efficacy’ & ‘other derivatives’ in Section 3(d) in consonance with the interests of society & drug industry. Anuradha Salhotra is at the forefront of managing the law firm Lall Lahiri & Salhotra for over 28 years, and has been involved in activities for creating awareness about the importance of protecting intellectual property and has also championed for reforms in India’s IP regime. Email: salhotra@lls.in

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IP MANTRA

‘In the race to get a drug to the market, it is likely that India can see a considerable opportunity coming into the country’ ...says Dr Mike James, Co-Director, Cambridge Regulatory Services, UK. He highlights the areas where India has an edge over the Chinese pharma manufacturers that has helped it enter new geographies, in conversation with Shivani Mody. What is the importance of seeking regulatory guidance for Indian companies? How do consulting firms such as Cambridge Regulatory Services help in the process? Entering into new geographies to tap opportunities is one of the key elements of growth for a company. As an initial step to hit a new market, the submission of documents and the process thereafter are critical for any organisation. The process of submitting

The interaction with the desired authority begins well before the formal submission of the documents. The constant dialogue and interaction can be supportive for understanding the requirements and doing the needful. Adding to this, every government or authority has its own rules and regulations that involve intricate detailed work. Also, the norms for filing documents in order to obtain an approval are different for the European Union (EU) and the US, which adds to the complexity. Even if a company gets an approval in one region, this does not guarantee the necessary approval in another region. Many Indian firms are now looking at entering into new geographies for growth. Some of these are also looking at setting up a base at international locations for R&D purposes. In all these cases, it is important to understand that proper documentation has to be ensured, and it must match with the requirements of each region and should also meet the desired deadlines. With our experience, we provide the appropriate guidance for firms that are looking at expanding into foreign regions. The right process at the first step will save a lot of time for a company in establishing an international base. In spite of the initial costs that can be a hindrance, one needs to consider that these costs are small compared to the following profits and brand image. It is worth the wait and effort, when compared to the benefits.

What are the issues in obtaining approvals in the EU and the US markets? The EU and US both follow the same guidelines, but their interpretations are different. The procedure followed in these countries is different. Both the EU and the US have practices of sending questions at different times, which need to be

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IP MANTRA

known during the approval procedure. When it comes to the EU, the complexity increases, as one has to get licences for 27 countries in that region. Each region in that country can have its own questions and the documents need to be submitted in different languages. Apart from showing its capability as a genuine, ethical player, a company has to answer all queries satisfactorily and be present at all times. Besides, the international standard requirement of products is different in these regions. To ensure error-free documentation, companies need to go in for detailed planning and build quality right from the start. Besides, it is necessary that the companies identify areas they need to reach out to. There are five-six big markets in the EU that may be beneficial for a company to tap into. The data from all clinical trials & other tests need to be comparable and presented in a format that is understood by different authorities. We guide companies in this procedure to help ensure smooth documentation and approvals.

What opportunities do you foresee in India? Several EU and US companies are planning to come to India for R&D activities, clinical trials, clinical trial studies, etc. The country holds an immense potential for outsourcing. In the race to get a drug to the market, it is likely that India can see considerable opportunity coming into the country. Outsourcing has also increased, as companies are looking at establishing their presence in India, and also be the first to bring out drugs in the market. This has seen companies wanting to make early applications for which data and successful trials are a must.

When it comes to outsourcing, what gives India an edge over China? India faces stiff competition from China in outsourcing. China’s Food and Drug Administration (FDA) is bureaucratic and the language barrier requires assistance of multiple interpreters; however, there are no such issues in India. India is also a preferred destination for outsourcing, considering the population genomics, which is different in China. While carrying out clinical trials in China, companies have to incur additional cost in proving the population group on whom the trials are conducted. On the other hand, Indian companies are aware of the internationally accepted standards such as Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), which makes the task easier for us, while guiding them. Additionally, many Indian firms have already established their presence in international markets, which gives them enough experience and edge to comply with international standards and demands. This makes them more knowledgeable, and they are aware of the basic requirements. This is reflected from the fact that many Indian firms have manufacturing facilities that are of international standards and at par with EU/US facilities.

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TECHNOFOCUS

RH calibration in stability studies

Controlling variations for accuracy Relative Humidity (RH) instruments are completely dependent on accurate calibration to deliver best of performance in a production unit. Even slight fluctuations in humidity can result in large variance in calibration, which could affect the quality of the finished product. Thus, pharma manufacturers need to select a good RH sensor for successful calibration. N M Mehta

quality. Slight variations in RH can have disastrous effects on stability output.

ew days after installation of a stability chamber, its Relative Humidity (RH) transmitters go out-of calibration. However, it goes unnoticed in the beginning. Sounds impossible? Well, it happens more often than what is usually thought about. Humidity calibration is difficult, and there are plenty of things that can go wrong. Sometimes, stability results are confusing and companies are unable to draw conclusions even after conducting investigation.

f

Is accuracy that important? RH instruments and all secondary RH sensors are absolutely dependent on accurate calibration in order to deliver their specified performance. As competitive and cost pressures mount, companies are determining with ever-greater clarity the effects of RH on their operations. In pharma manufacturing facilities, out-of tolerance RH levels cause clumping in fine powders, fouling expensive tableting processes and affecting finished product

A method of humidity generation A steam generator is a tank with an immersion heater. As the water in the tank is heated, steam rises up a tube to the chamber’s mixing plenum (where the main heaters and cooling coil are). The chamber, based on humidity demand, controls the output of the heater.

Steam generator

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The trouble with RH Why is there such a difficulty in working with RH? The basic reasons seem elementary enough. Humidity refers to airborne water or vapour, which is water in a gaseous state. RH is simply the measure of the amount of water vapour in the air compared to how much it can possibly hold at that temperature. From a theoretical perspective, these concepts are easy to understand, but on a practical level, the process is not only complicated but even counter-intuitive. Wide dynamic range: RH is more difficult to measure than most water-related or atmospheric properties, such as temperature, pressure, flow, volume, mass or level. The complexity begins with the broad range of moisture conditions that RH sensors must operate in. For example, a sensor rated to measure 10-90 per cent RH from - 40 to 70°C must perform in humidity conditions ranging from 10,000 parts per billion (ppb) to 200,000,000 ppb. This represents a dynamic ratio of 20,000: 1 – a figure that would challenge the linearity of most measuring devices, regardless of the property measured. Temperature dependence: RH creates difficulty because it is a temperature-dependent variable. Its value can change significantly with even slight variations in temperature and without any increase in moisture. For example, a 1ºC variance in temperature at 20ºC and 50 per cent RH can introduce an error of ±3 per cent RH, which results in an enormous variance in a calibration process. At 90 per cent RH, even a 0.2ºC variance will result in a ±1 per cent RH error. These temperature effects highlight the importance of thermal stability.


TECHNOFOCUS

Stability studies are worst affected by incorrect humidity readings or sensor selection. Accuracy, repeatability, response time, yearly drift are some of the most important parameters for selecting a humidity sensor for stability chamber. Sensors in stability chambers: Stability studies are worst affected by incorrect humidity readings or sensor selection. Accuracy, repeatability, response time, yearly drift are some of the most important parameters for selecting a humidity sensor for stability chamber. The accuracy of sensor defined for the operational range must always be checked. It is often defined for 30-90 per cent RH only. Response time of many RH sensors is more than 10 minutes. This results in more variation in humidity, which may not be detected. As a result, samples are exposed to continuous humidity variations. Yearly drift is the most important parameter to consider, as in many types of RH sensors drift is more than 5 per cent RH per year. Still it is been observed that sensors used in accelerated conditions stability chamber drift more than 10 per cent RH. Selection of a good RH sensor is very important for proper stability results. Use of more than one sensor in stability chamber is advisable to know about any drift happening in controlling systems. A possibility of drifting two sensors at the same time is a rare occurrence.

The complexity of calibration RH calibration, at first glance, can appear simple and basic. In reality, it is a complex and time-consuming process filled with potential pitfalls. Despite the importance of an accurate RH in an organisation, many people are unaware of the pivotal role calibration plays and still more are unaware of the key factors for a successful calibration. With the continuously rising quality & regulatory pressures, it is important for companies to fully understand and evaluate their processes to help prevent adverse happenings. N M Mehta is Managing Director of Newtronic Equipment Company Pvt Ltd. He can be reached on email: nmehta@newtronic.in

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CASE STUDY

SAS PheedIT

Clinical data management simplified Neeman Medical International has deployed a web-enabled SAS PheedIT solution for handling data transformation, data imports & exports, analysis and reporting to enhance its clinical trials process. This has enabled Neeman's clinical data management services to adhere to worldwide, uniform standard of conduct and other compliance requirements. adheres to a worldwide, uniform standard of conduct and Standard Operating Procedures (SOPs) that meet Food & Drug Administration (FDA) as well as International Conference on Harmonisation (ICH) requirements. In order to achieve their goal of worldwide consistency, NMI has implemented continuous quality compliance measures that include verification of protocol compliance, source documentation and compliance with sponsor/project-specific/ NMI SOPs. Each location uses a computerised study management system to effectively track all elements of trials at all Neeman locations across the globe to maintain consistency from one location to another, with secure environmentally controlled facilities, as well as SOPs for distribution and inventory management. The various NMI locations have the expertise to assist pharma, biotech and device industries in all aspects of clinical trial. These include obtaining Ministry of Health approval, import license for trial drug and other material, licence for export of biologic fluids to central laboratories outside the country, etc.

The challenge eeman Medical International (NMI) is the only international Site Management Organisation (SMO) in the world, which supports clinical trials enrolment needs of pharmaceutical, biotech and Contract Research Organisation (CRO) clients. Headquartered in Raleigh, North Carolina, NMI has its presence in the US, Costa Rica and India. Each location provides comprehensive infrastructure needed to support clinical sites at the desired geographic area. NMI

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As a part of its growth strategy in India, Neeman was entering Clinical Data Management (CDM) services as an extension of site management services. This created the need for an integrated web-enabled solution for CDM. Given its strict adherence to international standards, Neeman needed to deploy a web-enabled, 21 CFR part 11 compliance solution. Validation was also a key concern along with the need to deploytrain-use on an urgent basis.

Why SAS? Dr

Ajoy

Kumar,

CEO,

Max

Neeman


CASE STUDY

SAS is a de facto standard in the life science industry for data management, analysis and clinical trial reporting. International Asia, avers, “We needed a single, simple and efficient solution for the entire clinical research process that would meet all statutory data regulatory requirements. Besides, we needed to graduate to a completely electronic web-based environment. SAS PheedIT solution met all the requirements perfectly.” SAS PheedIT – a web-based solution – offered all the required components and experience for successful implementation. It provided a robust data entry portal integrated with the ability to handle data transformation, data imports & exports, analysis and reporting. It was a flexible management solution, which enabled any type of sharing of web-based information. Above all, SAS is a de facto standard in the life science industry for data management, analysis and clinical trial reporting. Given the urgency of the requirement, the SAS team completed the implementation including validation of the complete solution in just eight days.

Key benefits SAS PheedIT offered an easy-to-use tool/application for anyone – general physicians, nurses, DMs, project managers, CRAs and others with specific access rights. For specific studies, PheedIT could also be linked to any web-based information page. This turned out to be an effective way of informing investigators and getting close to opinion leaders. PheedIT allowed the users to access partial study data and study performance reports from checks, data management, which reduced the cost to a great extent. It allowed the users to carry out retrospective studies, with import and export of data from the system. It also allowed export of clinical study data into a more analysis-friendly structure (the analysis database). This database is then used by the PheedIT report engine to generate standardised reports, analysis, graphs, etc, and can easily be used by internal/external statisticians who are given access to the system. With SAS PheedIT solution, Neeman International India has become a highly reliable partner for clinical trials process and offers clinical data management services with the same adherence to worldwide, uniform standard of conduct and SOPs that meet FDA and ICH requirements. (Email: ashit.panjwani@sas.com)

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EVENTS CALENDAR

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Madhya Pradesh Jan 7-10, 2011

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IDMA 49th Annual Day

PHARMAC INDIA 2011

The Indian Drug Manufacturer’s Association (IDMA) is organising its Annual Day Celebrations. 49th Awards will be given out awards for the best patent, quality excellence in the field of manufacturing units, excellence in research for best research papers published in its Scientific and Research Publication ‘Indian Drugs’; January 7, 2011; Hotel JW Marriot, Mumbai

This Indian pharmaceutical industry exhibition provides a unique platform and resources to the organisations in the pharma industry with a futuristic understanding of the Indian pharmaceutical industry and market potential for their products across the world; February 12-14, 2011; Ahmedabad Education Society Ground, Ahmedabad For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91 22 2410 2801 Fax: +91 22 24102805 Email: amd.exb1@orbitzexhibitions.com Website: www.pharmacindia.com

For details contact: IDMA Tel: + 91 9867634383 Fax: +91 22 24950723 Email: prach17@gmail.com Website: www.idma-assn.org

3rd IPA Convention Plastivision India 2011 An exhibition organised by AIPMA, Plastivision India 2011 is the 8th in series, and this event will highlight the key developments & growth of the plastics industry; January 20-24, 2011; NSE Complex, Mumbai For details contact: AIPMA, Mumbai Tel: +91 22 67778899, Fax:+91 22 28252295 Email: marketing@plastivision.org Website: www.plastivision.org

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The 3rd Indian Pharmaceutical Association (IPA) Convention is a platform for manufacturers of laboratory equipment, machinery, pharmaceuticals along with personnel engaged in pharma software, books and career counselling to showcase their products and services. There will also be a satellite workshop on current topics and exclusive session on community pharmacy apart from addresses from eminent speakers; February 19-20, 2011; Indore

December 2010

Concurrent Shows

Maharashtra February 17-19, 2011 Bombay Exhibition Centre

One of the largest advanced design and manufacturing events in India featuring Machine Tools, Material Handling and Safety Equipment, Automation & Instrumentation, Hydraulics & Pneumactics, Process Machinery & Equipment, Packaging & Auxiliaries, IT Products, Electrical & Electronics.

For details HiTech Manufacturing Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4650 • Fax: 022 3003 4499 • Email: hitech@infomedia18.in For details contact: Pharmaexcil Tel: + 91 40 23735462 Fax: + 91 40 23735464 Email: info@pharmaexcil.com Website: www.ipapharma.org

25th Pharma Bio World Expo This is one of the foremost shows for pharma and the biotech industry. One of the largest exhibition and conference for the chemical and the pharma industry, where industry professionals, decision-makers and senior managers from related industries will be displaying their varied products; February 23-26, 2011; Bombay Exhibition Centre, Mumbai For details contact: Chemtech Foundation Tel: + 91 22 22874758 Fax: + 91 22 22870502 Email: conferences@jasubhai.com Website: www.chemtech-online.com


EVENTS CALENDAR

International Arab Health Arab Health is the premier exhibition and congress in the Middle East. The event will showcase the new products, innovations and technologies to one of the fastest growing healthcare markets in the world; January 24-27, 2011; Dubai International Convention & Exhibition Centre, United Arab Emirates For details contact: IIR Middle East Tel: +971 4 407 2410; Fax: +971 4 336 4021 Email: terri.delia@iirme.com Website: www.arabhealthonline.com

3rd International Conference on Drug Discovery and Therapy The event provides a platform for all pharmaceutical scientists, internists and primary care physicians to discuss and learn about all the important international breakthrough developments on drug discovery and new therapeutics. It also focuses on the interdisciplinary fields of drug discovery, drug therapy and translational medicine; February, 7-10, 2011; Dubai

suppliers of process plant and equipment. This exhibition will provide a platform for service providers to showcase their products and services to decision makers from leading pharmaceutical manufacturers; May 10-12, 2011; at Charlotte Convention Centre, Charlotte, USA

For details contact: The ARABLAB Group Tel: + 971 4 397 5418 Fax: + 971 4 397 5419 Email: info@arablab.com Website: www.arablab.com

BIOTECH WORLD 2011 The exhibition will show processes and devices for biotechnological productions and laboratory researches, wide range of biological preparations for pharmaceutical, food industry, agricultural sector and also biological agents, bioactive additives, test-systems, alternative energy sources, nano-molecular energy converters, specialised devices of the industrial and laboratory safety; March 21 - 24, 2011; The House of Moscow Government, Russia For details contact: JSC Expo-Biochim-Technologies Tel: +7 (495) 933-90-51 Fax: +7 (495) 933-90-54 Email: atv@biomos.ru Website: www.mosbiotechworld.ru/eng

DUPHAT 2011 For details contact: Eureka Science Ltd Tel: + 971 6 557 5783 Fax: + 971 6 557 5784 Email: info@icddt.com Website: www.icddt.com

Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) is an annual pharmaceutical event since its inception in 1995; March 22-24, 2011; Dubai International Exhibition Centre, UAE

ARABLAB 2011

For details contact: Index (Conferences and Exhibitions Organisation Est) Tel: +971 4 3624717 Fax: +971 4 3624718 Email: index@emirates.net.ae Website: www.duphat.ae

For details contact: Arosa Exhibitions Limited Tel: + 1 (980) 2198449 Email: gviniconis@arosa-group.com Website: www.charlotteconventionctr.com

CPhI China 2011 CPhl China is a platform where pharmaceutical manufacturers, biopharmaceutical companies biotechnology companies & API manufacturers can display variety of products and services. About 89 per cent of visitors are expected to attend CPhl China 2011. This is a meet which enables business partnerships, launch new products and showcase innovations; June 21-23, 2011; Shanghai New International Expo Centre (SNIEC), Shanghai, China For details contact: Cphl China 2011 UBM International Media Tel: +31 (0) 204 099 593 Email: haohao.chen@ubm.com Website: www.cphi-china.com

Bio-Europe Spring 2010 ARABLAB is the global buying source for tomorrow’s decision reaching technology makers & end-users, as well as being a truly unique research source. Connecting people from over 75 countries, this expo showcases the very latest lab and instrumentation equipment from the world’s leading manufacturers; March 7-10, 2011; Dubai International Convention & Exhibition Centre, United Arab Emirates

Bio Europe Spring 2011, a three day exhibition, is a forum to promote business development between pharmaceutical, financial and biotechnology companies in Italy; November 14-16, 2011; Milano Convention Centre, Milano, Italy

International Pharmaceutical Exhibition The International Pharmaceutical Exhibition will bring together the manufacturers and

For details contact: BIO (Biotechnology Industry Organization) Tel: +1 202 962 9200; Fax: +1 202 488 6301 Email: cbeckman@bio.org Website: www.bio.org/events

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 Pharmaceuticals

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REPORT

P-MEC & CPhI India 2010

Placing India at the forefront True expectations manifest in terms of participation. The three-day exhibition of CPhI, P-MEC, BioPh and ICSE witnessed a power-packed response from exhibitors and visitors, not only from the country but also overseas. A glimpse of the event, by Chandreyee Bhaumik. Unlike the previous year, this time the seminars & workshops were held at Westin Mumbai Garden City. The seminars discussed issues concerning the growth of the Indian pharma industry & offered the solutions to these problems. Thought leaders present at the seminars helped pave the way forward for the industry to keep pace with the global market.

Indian pharma, way to go...

uring December 1-3, Mumbai witnessed the fifth edition of CPhI, P-MEC, BioPh and ICSE, one of South Asia’s largest pharmaceutical events, at Bombay Exhibition Center. The event was organised by UBM in partnership with Pharmaceuticals Export Promotion Council (Pharmexcil). Approximately, 52 per cent of the participants were from India and 40 per cent from China, according to the organisers. Also, 66 per cent of the participants were from Asia, 7 per cent from Africa, 6 per cent from North America and 1 per cent from South America. The event saw a footfall of about 800 exhibitors and 30,000 visitors.

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Prominent voice Speaking at the occassion, Srikant Kumar Jena, Union Minister of State for Chemicals & Fertilizers, opined, “The Indian pharma industry is now over $ 20 billion. India ranks 14th, in terms of value and fourth in terms of export value of bulk actives & dosage forms.” Giving a futuristic view, he elaborated, “By 2015, India is expected to rank among the top 10 global pharma markets. The industry is growing at about 1.5-1.6 times the country’s Gross Domestic Product (GDP) growth.”

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Besides the exhibitors, which included the leading names from the pharma industry, the first day of the seminar witnessed discussions on advanced Active Pharmaceutical Ingredient (API) strategies. These included measures to drive quality & costefficiency throughout the Indian API industry, ways to leverage advanced manufacturing technologies, and processes to ensure cost-effective production of advanced APIs. Other seminars during the later part of the day encompassed strategies for driving export opportunities in regulated markets of the US, Europe and Japan. On the second day, presentations were given on integrated R&D, process development and methods of adopting good manufacturing practices to develop cost-effective biosimilars. The vaccine industy, which is witnessing a steady growth, was also discussed. During the later part of the day, there were talks on nanotechnology applications and commercialisation of stem cells. On the last day, there were discussions on trends that demonstrated ways to leverage targeted drug delivery systems for anti-cancer drug development. With India becoming the outsourcing hub for the global industry, the leaders also highlighted ways to leverage the Contract Research and Manufacturing Services (CRAMS) opportunity and suggested ways to improve the infrastructure. The exhibition showcased the latest equipment and machinery being used in the pharma industry. It certainly provided a platform to entrepreneurs and allied industries to grow big and get better.


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TECHNOLOGY TRANSFER

Technology Offered 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. 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

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. Moreover, this product has already been launched in American market. Areas of application Pharmaceutical industry Forms of transfer Equipment supply

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

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

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

Intravenous fluids An Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around ` 15 crore. The company can offer consultancy services/technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party

can set up its own factory when it is ready for investments. Areas of application Pharmaceutical industry Forms of transfer Joint venture, technical services

Purified microfine red sanders wood powder An Indian company offers red sanders wood, which is a precious crude drug in the ayurvedic system of treatment. Pulverising by conventional technologies generates very high temperature, which in turn leads to high ash in the sanders wood powder. Red sanders powder so produced will be rich in drug and colour values. The powder will be microfine and free from ash and other impurities. Red sanders wood powder is used to apply on the face and skin to remove chicken pox marks, marks from burns, skin discolourations and pimples. It is also used to add in several drugs, processed foods, cosmetics and toiletries. The powder can be exported in large quantities as a value added item. The technology for microfine pulverising of red sanders wood was developed with the support of DSIR, under the Ministry of Science and Technology. Areas of application Ayurvedic pharmaceutical, food and cosmetics industries Forms of transfer Turnkey, others

Share Your Technology Propositions The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column of Modern Pharmaceuticals. R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification. Contact: Modern Pharmaceuticals Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671  Fax: 022-3003 4499  Email: spedit@infomedia18.in

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TECHNOLOGY TRANSFER

Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development 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; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality. Areas of application Biotechnology, engineering, new technology Forms of transfer Consultancy

Areas of application Cell culturing - molecular biology Forms of transfer Material supply

Extract of medicinal and aromatic plants An Indian 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

Glove automation equipment Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate. Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others

An Indian company requires technology to produce glove by automation process. Areas of application Manufacturing industries, especially rubber industry and latex industry Forms of transfer Consultancy

Cell lines

Kite grading engineering technology

A Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the company’s product lines and service customers/researchers/ scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals.

A Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff. Areas of application Medical research Forms of transfer Joint venture, partnership

Medical products An Indian company wants to manufacture intravenous fluids, saline, dextrose and related products used in the medical field. The company is involved in non-medical activities at present. The only medical involvement is its general practice in the UK. It plans to commence a nursing home project in Sri Lanka and would be interested in a joint venture with a suitable partner for its saline project. The project has been approved for tax concessions and its partner is expected to contribute in machinery production and know-how. Areas of application Medical and surgical Forms of transfer Others

Methyl cobalmine An Indian company requires technology for production of methyl cobalamine, which is an important basic drug. Areas of application To be used in pharmaceutical industries Forms of transfer Others

Pharma grade mannitol An Indian company requires the know-how for manufacturing pharma grade mannitol. The estimated production capacity is 600 tonne per annum Areas of application Pharmaceuticals Forms of transfer Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016 Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org

For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

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PRODUCT UPDATE

Vial & bottle cap sealing machines

Blister packing machine

Anju Pharmaceuticals offers vial and bottle cap sealing machines that are compact, versatile and elegantly finished devices for sealing vials & bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium or plastic caps. The vials ready for sealing are placed one-byone on the self-lifting stainless steel platform. This platform lifts upward automatically. As a result, the vials touch the sealing head, thereby lifting the head upwards. Sufficient time is provided to remove the vial platform after the completion of sealing operation. The features of the machine include: perfect & uniform sealing, therefore no manual involvement; no repeated setting required; sealing rollers rotate on bearings to give smooth motion for uniform sealing; minimum time require for changeover from one size of vial to another; and does not require lubrication.

Advanced Liquid Packaging offers ‘Model PBM-140C’ high-speed mass production blister packing machine designed to pack all types of capsules, tablets, softgels, injection solution, syringe and other small laboratory or hospital preparation products. It can also pack small products in different types of clamp shell packages. It is widely used in the pharmaceutical, herbal, food and other related industries. It is suitable for packing with aluminium/PVC, paper/plasticlaminated materials. This machine consists of aluminium foil automatic feeding, upper and lower cobweb male and female joining, multistage cylinder heat sealing, automatic indenting, batch number printing and aluminium alloy double heating. The spaces between the parts of shaping, heat sealing and cutting can be adjusted as required. It has a planned-hear speed reducer with low noise and long service life. The frequency control of motor speed has high performance and efficiency, with a cutting of 35 times a minute.

Anju Pharmaceuticals - Indore - Madhya Pradesh Tel: 0731-252 3968/7415, Fax: 0731-285 6142 Email: anjupharma@hotmail.com

Fluid bed dryer Amulya Industries offers fluid bed dryer. This dryer is used for drying powders and granules in industries such as pharmaceuticals, chemical, food, cosmetic and dye. It is available in 2, 5, 10, 30, 60, 120, 300 and 500 kg capacity as per GMP standards with validation documentation. The structure is fabricated of rigid square pipes of SS-304/claded and polished to matt surface finish. All MS parts fabricated to smooth surface and painted. The contact parts are made of SS-304/316 with all joints fusion free argon arc welded. The internal surface is ground and polished to mirror finish. The control panel is fabricated of SS-304. It is mounted on machine stand for easy accessibility. The panel consists of switch gear fuses, relays, motor starter, indicating lamp, push buttons, etc. The drying time taken by this dryer for pharmaceutical granules and powders having 20-25 per cent moisture is approximately 30-45 minutes at 80°C temperature, depending on physical properties of material, type of moisture contents, drying temperature, etc. Amulya Industries - Mumbai - Maharashtra Tel: 022-2852 0116, Fax: 022-2851 6488 Email: aamulya@vsnl.net

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Advanced Liquid Packaging - Arizona - USA Tel: +1-602 490-0220, Fax: +1-480 393-4108 Email: sales@induction-sealers.com

Liquid filling machine Harshika Industries offers fourhead liquid filling machine. It is a highly versatile machine for filling foamy as well as other liquids into containers. It has a unique bottle separation method in which no turret or holding slides are used. This machine fills the liquid using the syringe principle and is very easy to use. Turntable is provided for bottle filling. This liquid filling machine is provided with variable speed conveyor and is suitable for filling all types of liquids with less density. It is equipped with 1.5 hp motor with gear box and diving nozzles that are used for prevention of spillage and for foamy liquids. Its features include fill volume 300 ml, fill speed 35 bottles per minute, conveyor length 6 feet, etc. Harshika Industries - Thane - Maharashtra Tel: 0250-324 6533, Mob: 98694 57909 Email: harshad.g@rediff.com


PRODUCT UPDATE

Stirring hot plate Cole-Parmer India offers ‘IKA® RCT Basic IKAMAG®’ digital stirring hot plate with stronger motor with a higher speed range up to 1,500 rpm and temperature control mode for faster heating of the medium. The PT 1000 temperature sensor ensures precise temperature control. The maximum stirring capacity (H2O) is 20 L. It features a highly polished aluminium round top heating plate, which provides efficient heat transfer than standard top plates. Hot plate features an over-temperature safety circuit adjustable from 50-310°C to protect the samples from overheating, hence suitable for unsupervised operation. The exact temperature and speed setting can be done via digital display. The hot top indicator shows temperature reading, thus preventing burns. The bushing is according to DIN 12878 for connecting a contact thermometer enabling precise temperature control. The stirring hot plate finds applications in various industries such as process, pharmaceuticals, biotech, chemical, petrochemical, refinery and food & beverage. The company also provides accessories such as temperature sensors, electronic contact thermometers, reaction vessels and stirring bars. Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222, Fax: 022-6716 2211 Email: response@coleparmer.in

Vision sensor Omron Automation offers ‘FQ’ vision sensor, which has been designed to simultaneously meet inspection reliability, ease of use and cost performance requirements. With one-touch control via user-friendly, icon-driven menu, crystal-clear image quality, real colour processing (16 million colours) and a one-touch control via PC or the intuitive touch finder console, the user can access all functions and settings quickly & easily. Furthermore, with its advanced processing tools, good image quality is achieved from even the most challenging surfaces. Omron Automation Pvt Ltd - Bengaluru - Karnataka Tel: 080-4072 6400, Fax: 080-4146 6403, Mob: 09980943045 Email: in_enquiry@ap.omron.com

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PRODUCT UPDATE

Leak test apparatus Jicon Machines offers leak test apparatus. It is ideal for checking sealing integrity of blister, strip & pouch packs, capped bottles, etc. The leak test apparatus is extremely compact in construction and has low noise level. It is provided with polycarbonate vacuum dessicator, which sustains vacuum for long durations. The apparatus is made of stainless steel (GMP). It is equipped with built-in vacuum gauge and isolation valve and is provided with 0-5 minute timer for auto-stop. The leak test apparatus has a vacuum level of 550 mm Hg. Jicon Machines Pvt Ltd - Mumbai - Maharashtra Tel: 022-2851 0398, Fax: 022-2851 6488 Email: jicon.ind@vsnl.com

Automatic capsule filler Karishma Pharma Machines offers ‘Model-A25’ highspeed automatic capsule filling machine. All the powder contact parts are made in stainless steel 316. The main body of the machine is fabricated out of SS-304. It is compact, sturdy, covered with stainless steel panels, and the hood is covered with acrylic guard. It is provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation within 2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. The faulty capsule and filled capsule ejection stations are equipped with individual air controls. This machine is simple to operate and easy to maintain. The special purpose gauges ensures quick and easy changeover. The appropriate sensors ensure continuous flow of powder and empty capsules for uninterrupted operation of the machine. The control panel of the machine is equipped with PLC system, enabling visual display of the operating parameters besides ensuring accuracy, reliability and reduced operator fatigue. Karishma Pharma Machines - Mumbai - Maharashtra Tel: 022-2380 5979, Fax: 022-2381 1849, Mob: 9821069064 Email: zabinmenon@vsnl.com

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PRODUCT UPDATE

Tablet compression machine Shiv Pharma Engineers offers tablet compression machine, (tablet press), which is used to makes the tablets according to a pre-determined design. Punches and dies set into the tablet press to actually shape the tablets. The machine makes tablets for a variety of industries, but their largest application is in pharmaceuticals and vitamins. It is provided with turret made of special grade SG iron casting and interlock switches for the safety of operator. The machine’s features include paint free compression zone, variable speed step pulley, dust extraction nozzles, antivibration mounting, etc. The models of tablet compression machine available with the company include lab press, single rotary tablet compression machine, double rotary tablet compression machine and heavy duty tablet compression machine. Shiv Pharma Engineers - Ahmedabad - Gujarat Tel: 079-2909 2380/2287 1399, Fax: 079-290 92380/2287 1399 Email: sales@shivpharma.com

Sticker labelling machine Denmark Machine Tools offers automatic vertical sticker labelling machine. This machine is suitable for labelling on round vials, bottles and other round objects. It is capable of labelling up to 150 containers per minute depending on product size and label size. It is equipped with roller spacing device and the in-built automated label length detection systems, which eliminates the need for manual feeding and storing of label length data in memory and retrieving the same for change of label size and re-starting the machine. Its features include no change parts required, maintenancefree machine, SS-304 construction, GMP design, user-friendly label placing adjustment, built-in AC variable frequency drive system, accurate label placement, in-built digital pulse counter, etc. Denmark Machine Tools - Ahmedabad - Guajrat Tel: 079-2220 1140, Mob: 097277 16599 Email: info@denmarkmachine.com

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PRODUCT UPDATE

Bottle washing machine Laxmi Industries offers ‘model HLBW-150’ highspeed linear bottle washing machine. This machine is totally fabricated from SS materials, including the basic frame. It is provided with high-pressure spray nozzles that ensure perfect wash of vials. It does not require any changeover parts for washing of bottles, thus saving time (on changeover). All parts coming in contact with washing zones/jet are made from SS-316 materials. The machine is suitable for washing of round and flat glass bottle. It is totally rigid and withstands continuous operation for long working hours without any trouble. Water re-cycling arrangement is provided as per customer’s requirement. Laxmi Industries - Ahmedabad - Gujarat Tel: 079-2289 3810 Email: laxmiindustries_ad@yahoo.com

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PRODUCT UPDATE

Strip seals Novoflex Marketing offers pilfer proof strip seals, which prevent imitation of branded & quality products and help in controlling adulteration & pilferage, thus protecting company’s reputation and brand image. These have a tamper evident locking action in a one-piece construction, and are precision-moulded from durable, tough, high-strength & weather-resistant engineering Nylon 66 material. These strip seals are light in weight, corrosion effective, economical and cost-effective. The company’s name/logo can be permanently hot stamped on it. These seals can be used in the pharmaceutical industries, bulk drugs, airlines baggages, postal department, chemical industries, bank lockers, courier bags, containers, drums, etc. Novoflex Marketing Pvt Ltd - Kolkata - West Bengal Tel: 099031 63634, Fax: 033-2229 7814 Email: sales@novoflex.co.in

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PRODUCT UPDATE

FRP storage tank EPP Composites offers FRP storage tank which is manufactured by hand lay-up and/or by filament winding process for the storage of highly corrosive chemicals, acids and wastes. It is available in capacity up to 250 kL in various shapes like square, round, rectangular vertical and horizontal with flat bottom or conical bottom. The key feature of this tank is that it offers resistance to chemical and weather. It is light in weight, easy to maintain and its features include good physical & mechanical strength. The reaction vessel is available with suitable lined agitator, gear box and electric motor. The company also manufactures FRP and dual laminated reaction vessels, pressure vessels and vacuum receivers for mixing and washing & filtration process. EPP Composites Pvt Ltd - Rajkot - Gujarat Tel: 02827-287059, Fax: 02827-287063 Email: marketing@epp.co.in

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

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2-way entry doors  Fuels- diesel 4-way entry doors  Fume extractors Accelerated ageing test  Fume hoods - constant Acoustic enclosures  Fumigation unit Air filters  Gases Analytical instruments  Gear oils Auto tube filling & sealing units  Geared box Automatic capsule filler  Geared motor Banking services  GMP heat exchangers Bearings  GMP reactors Biodiesel  HEPA filter terminal housing Biological safety cabinet  HPLC Blister packaging machine  Hydrogenator/autoclaves Blister packing machine  Industrial control & sensing devices Blistrip  Informatics Bottle washing machine  Injectable manufacturing line Cable carriers  Injectable powder filling machines Cable connectors  Invertor/variable frequency drives Capping machines  Knife mill Capsule section machines benches/cabinets  Laboratory First Fold Here Chains  Laminar air flow workstation Chemical storage cabinets  Leak test apparatus Clean room doors  Level controllers Columns & chemistries  Lipid food processing machine Compositional & trace metal analysis  Liquid filling lines Conical screw dryers  Liquid filling machine Connectors  Liquid filling machines Counters & power supplies  Lubes- engine oils Crushers  Material identificaton unit Dispensing booth  Measuring & monitoring relay Double sided rotary tablet press  Metallography Drives  Mixer Dry syrup powder filling lines  Motion controls Dry vane pumps  Mullers Ducting and vav system  Multi-function mill Ensule automatic capsule filling  Ointment/cream/paste section Evaporative cooling tower machines Exhaust blowers Packaging machines  Exhibition - Engineering Expo Exhibition - Hi Tech Manufacturing  Packaging nits  Pass boxes Show Exhibition - Plastvision India 2011  Petrol & fuel oils  Photo electric sensors Failure analysis Second Fold Here  Plastics pallets Fan filter unit Pneumatic component  Fill tube unit Polymer characterisation  Filler compositional analysis  Pre-engineered & pre-fabricated Filters modular panel Filtration equipment  Process heat exchangers Filtration systems  Process reactors Financial services  Programmable logic controllers Fluid bed dryer  Programmable terminals Fogging machine Food analysising & testing machine  Proximity sensors FRP storage tank  Pumps

                                                   

Quality control equipments & apparatus Quick change terminal house Rapid endotoxin detection system Restricted by-pass Return air risers RFID Roots blowers Rotary tablet press Rotary vacuum dryers Rotocone dryers Safe change housing Safety light curtains Safety monitors/controls Sampling booth Screening machine Separators SEZ developers Silicone carbide heat exchangers SME finance Software Spherical paddle chopper dryers Sterilising/depyrogenating tunnel Sticker (self-adhesive) labelling machines Sticker labelling machine Stirring hot plate Strip seals Switching relays Tablet bottle packing lines Tablet compression machine Tablet press machine Tablet section machines Tableting machines Tempurature controllers Testing Timers Transmission fluids Turnkey projects ULV fogging machine UPLC Vacuum booster pump Vacuum systems Vacuum technology Valves Vials & bottle cap sealing machines Vision product Vision sensor Vision sensors Walk-in models Warehousing Washing and air jet cleaning machines Wastewater treatment equipment Wet glue labelling machine

Send your inquiries at: Tel: +91-22-3003 4684 / 4640 • Fax: +91-22-3003 4499 E-mail: b2b@infomedia18.in

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Please complete the following & get a quick effective response from suppliers: 1. Your company’s business function is (one only)  Wholesalers  Manufacturer  Distributor  Agent  Other, please specify ______________ 2. Your role in your company’s buying process can best be described as:  I buy  I identify potential suppliers  I approve purchases  I negotiate contracts  I select suppliers. 3. Your line of business Name: Designation: Company Name:

City:

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Yo u r i n f o r m e d s o u r c e f o r P r o d u c t s , P r o c e s s & M a c h i n e r y

12/ 2010

Address:

Ruby House, ‘A’ Wing, J.K. Sawant Marg, Dadar (W), Mumbai 400 028, INDIA.

INFOMEDIA 18 LIMITED Special Projects POSTAGE WILL BE PAID BY ADDRESSEE

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Business Reply Inland

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ADVERTISER INQUIRY FORM

U 

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Tel.: +91-22-3003 4684



Fax.: +91-22-3003 4499 Email: b2b@infomedia18.in 

 All India Plastics Mfrs Association

 International Marketing Services

 Bonfiglioli Transmissions (Pvt) Ltd

 J B Sez Pvt Ltd

 Brothers Pharmamach (India) Pvt Ltd

 Jicon Industries

 Cadmach Machinery Co Pvt Ltd

 LMT India Pvt Ltd

 Charles River

 Milltech Engineering Pvt Ltd

 Cognex Singapore Inc

 Nokia India Pvt Ltd

 Dipesh Engineering Works

 Omron Automation Pvt Ltd

 Engineering Expo

 Premium Transmission Ltd

 Everest Blowers

 Radiant Enterprise

 Fabtech Technologies Intl Pvt Ltd

 Shiva Analyticals (India) Limited

 Gem Equipments

 Sintex Industries Ltd

 Gordhandas Desai Pvt Ltd

 Smart Logistics

 Guan Yu Machinery Factory Co Ltd

 Standard Chartered Bank

 Hi Tech

 Waters (India) Private Limited



First Fold Here

 Igus India Pvt Ltd

Second Fold Here Please complete the following & get a quick effective response from suppliers: 1. Your company’s business function is (one only)  Wholesalers  Manufacturer  Distributor  Agent  Other, please specify ______________ 2. Your role in your company’s buying process can best be described as:  I buy  I identify potential suppliers  I approve purchases  I negotiate contracts  I select suppliers. 3. Your line of business Name: Designation: Company Name:

City:

Pin:

Tel:

Fax:

Email:

Yo u r i n f o r m e d s o u r c e f o r P r o d u c t s , P r o c e s s & M a c h i n e r y

12/ 2010

Address:

Third Fold Here

GLUE



4. Specific product requirement


POSTAGE WILL BE PAID BY ADDRESSEE

Business Reply Inland BR Permit No. 555 Bhavani Shankar Post Office, Mumbai 400 028.

NO POSTAGE STAMP NECESSARY IF POSTED IN INDIA

Special Projects

INFOMEDIA 18 LIMITED Ruby House, ‘A’ Wing, J.K. Sawant Marg, Dadar (W), Mumbai 400 028, INDIA.


PRODUCT INDEX

Product

Pg No

2-way entry doors............................................81 4-way entry doors............................................81 Accelerated ageing test....................................67 Acoustic enclosures .......................................... 17 Air filters....................................................... 21,23 Analytical instruments ..................................... 77 Auto tube filling & sealing units ..................... 65 Automatic capsule filler ................................... 82 Banking services ..............................................69 Bearings ............................................................... 6 Biodiesel ............................................................ 67 Biological safety cabinet .............................. 21,23 Blister packaging machine .......................... 65,80 Blistrip ............................................................... 65 Bottle washing machine ................................... 84 Cable carriers.....................................................6 Cable connectors ................................................ 6 Capping machines .............................................. 9 Capsule section machines ................................ 65 Chains.................................................................. 6 Chemical storage cabinets................................ 83 Cleanroom doors......................................... 21,23 Columns & chemistries.................................... 77 Compositional & trace metal analysis ............ 67 Conical screw dryers........................................... 5 Connectors .......................................................... 6 Counters & power supplies........Front inside cover Crushers............................................................. 11 Dispensing booth .......................................21,23 Double-sided rotary tablet press ..................... 15 Drives........................................Back inside cover Dry syrup powder filling lines ........................... 9 Dry vane pumps ............................................... 17 Ducting and vav system ................................... 83 Ensule automatic capsule filling ....................65 Evaporative cooling tower ............................... 12 Exhaust blowers ................................................ 83 Exhibition - Engineering Expo ................... 29,63 Exhibition - Hi Tech Manufacturing Show ....... 73 Exhibition - Plastivision India 2011.................. 8 Failure analysis ................................................67 Fan filter unit ............................................... 21,23 Fill tube unit ..................................................... 65 Filler compositional analysis............................ 67 Filters ................................................................. 11 Filtration equipment ........................................ 11 Filtration systems.............................................. 11 Financial services .............................................. 69 Fluid bed dryer ................................................. 80 Fogging machine............................................... 83 Food analysing & testing machine .................. 11 FRP storage tank............................................... 88 Fuels - diesel...................................................... 67

Product

Pg No

Fume extractors ................................................ 83 Fume hoods - constant .................................... 83 Fumigation unit................................................ 83 Gases.................................................................67 Gear oils ............................................................ 67 Geared box ........................................................ 25 Geared motor.................................................... 25 GMP heat exchangers......................................... 5 GMP reactors ...................................................... 5 HEPA filter terminal housing ...................21,23 HPLC ................................................................. 77 Hydrogenator/autoclaves ................................... 5 Industrial control & sensing devices...................................... Front inside cover Informatics ........................................................ 77 Injectable manufacturing line..................... 21,23 Injectable powder filling machines ................... 9 Invertor/variable frequency drives .................................... Front inside cover Knife mill .........................................................11 Laboratory benches/cabinets..........................83 Laminar air flow workstation ..................... 21,23 Leak test apparatus ........................................... 82 Level controllers..................... Front inside cover Lipid food processing machine ....................... 11 Liquid filling lines............................................... 9 Liquid filling machine ................................... 9,80 Lubes - engine oils............................................ 67 Material identificaton unit .............................67 Measuring & monitoring relay ...................................... Front inside cover Metallography ................................................... 67 Mixer ................................................................. 47 Motion controls ..................... Front inside cover Mullers............................................................... 11 Multi-function mill .......................................... 11 Ointment/cream/paste section machines......65 Packaging machines .....................................9,65 Packaging nets................................................... 81 Pass boxes..................................................... 21,23 Petrol & fuel oils............................................... 67 Photoelectric sensors ............. Front inside cover Plastics pallets ................................................... 81 Pneumatic component ..................................... 11 Polymer characterisation.................................. 67 Pre-engineered & pre-fabricated modular panel ........................................................... 21,23 Process heat exchangers ..................................... 5 Process reactors................................................... 5 Programmable logic controllers.....Front inside cover Programmable terminals....... Front inside cover Proximity sensors .................. Front inside cover

Product

Pg No

Pumps................................................................ 17 Quality control equipment & apparatus .......65 Quick change terminal house..................... 21,23 Rapid endotoxin detection system.................87 Restricted by-pass ............................................. 83 Return air risers ........................................... 21,23 RFID ....................................... Front inside cover Roots blowers.................................................... 17 Rotary tablet press ............................................ 15 Rotary vacuum dryers ........................................ 5 Rotocone dryers.................................................. 5 Safe change housing...................................21,23 Safety light curtains ............... Front inside cover Safety monitors/controls .................................. 83 Sampling booth............................................ 21,23 Screening machine............................................ 11 Separators .......................................................... 11 SEZ developers............................. Front gate fold Silicone carbide heat exchangers ....................... 5 SME finance ...................................................... 69 Software ............................................................. 19 Spherical paddle chopper dryers ....................... 5 Sterilising/depyrogenating tunnel .............. 21,23 Sticker (self-adhesive) labelling machines ........ 9 Sticker labelling machine ................................. 83 Stirring hot plate............................................... 81 Strip seals........................................................... 87 Switching relays ..................... Front inside cover Tablet bottle packing lines ...............................9 Tablet compression machine........................... 83 Tablet press machine........................................ 15 Tablet section machines ................................... 65 Tableting machines............................. Back cover Tempurature controllers ....... Front inside cover Testing ............................................................... 67 Timers..................................... Front inside cover Transmission fluids .......................................... 67 Turnkey projects................................................. 5 ULV fogging machine .....................................83 UPLC ................................................................. 77 Vacuum booster pump ...................................17 Vacuum systems ............................................... 17 Vacuum technology.......................................... 81 Valves................................................................. 83 Vials & bottle cap sealing machines................ 80 Vision product .................................................... 7 Vision sensors .................. Front inside cover, 81 Walk-in models ...............................................83 Warehousing ..................................................... 81 Washing and air jet cleaning machines ............ 9 Wastewater treatment equipment ................... 11 Wet glue labelling machine ............................... 9

COMPLETE ENGINEERING UNDER ONE ROOF @ www.engg-expo.com

December 2010

Modern Pharmaceuticals

93


ADVERTISERS’ LIST

Advertiser’s Name & Contact Details All India Plastics Mfrs Association

Pg No 8

Advertiser’s Name & Contact Details

Pg No

Fabtech Technologies Intl Pvt Ltd

21,23

Advertiser’s Name & Contact Details Milltech Engineering Pvt Ltd

T: +91-22-28271678

T: +91-22-61592900

T: +91-22-22872295

E: info@plastivision.org

E: mails@fabtecheng.com

E: info@milltechengg.com

W: www.plastivision.org

W: www.fabtecheng.ae

W: www.milltechengg.com

Bonfiglioli Transmissions (Pvt) Ltd

BIC

T: +91-44-24781035 E: sales@bonfiglioliin.com

Gem Equipments

9

T: +91-79-40213213

T: +1800-103-1792 W: www.tej.nokia.com

T: +91-265-2340795

15

E: srirams@ap.omron.com W: www.omron-ap.com

11

T: +886-4-896-5198 E: guanyeu@ms39.hinet.net

E: info@cadmach.com

W: www.gy-1000.com.tw

W: www.cadmach.com

Hi Tech 87

E: india.customercare@crl.com

Igus India Pvt Ltd

W: www.criver.com

T: +91-80-39127800 7

Radiant Enterprise

E: radiant_enterp@rediffmail.com W: www.fogstarindia.com 6

W: www.shivatec-india.com 81

E: sales@dipeshengg.net W: www.dipeshengg.com 29,63

T: +91-09920401226 E: engexpo@infomedia18.in W: www.engg-expo.com 17

81

E: pallets@sintex.co.in

E: ims_blr@sify.com J B Sez Pvt Ltd

Sintex Industries Ltd T: +91-2764-253500

5

T: +91-22-26743719

FGF

W: www.sintex-plastics.com

T: +91-22-66210000

Smart Logistics

E: aparadkar@jbsez.com

T: +91-22-30034650

W: www.jbsez.com

E: prachi.mutha@infomedia18.in

Jicon Industries

65

10

Standard Chartered Bank

T: +91-22-28510398

T: +91-22-39401616

E: jicon.ind@vsnl.com

E: sme.custoercare@sc.com

W: www.jicon.com

W: www.standardchartered.co.in

LMT India Pvt Ltd

67

E: gupta@shivatec-india.com

T: +91-80-23310124

W: www.cognex.com.sg

Shiva Analyticals (India) Limited T: +91-80-27971322

E: info@igus.in

International Marketing Services

E: herlinda.xu@cognex.com

Everest Blowers

83

73

W: www.igus.in

T: +65-6325-5947

Engineering Expo

T: +91-20-27488886 W: www.premiumtransmission.com

T: +91-09820373804 E: hitech@infomedia18.in

Dipesh Engineering Works

25

T: +91-79-66615344

T: +91-80-25588175

Cognex Singapore Inc

T: +91-80-40726400

Premium Transmission Ltd Guan Yu Machinery Factory Co Ltd

T: +91-79-25841491

Charles River

FIC

W: www.gdpl.com

W: www.brothers.co.in Cadmach Machinery Co Pvt Ltd

Omron Automation Pvt Ltd 83

E: labexcel@gdpl.com

E: brothers@usa.net

19

E: sales@gemindia.com

Gordhandas Desai Pvt Ltd

47

Nokia India Pvt Ltd

T: +91-422-3267800

W: www.gemindia.com

W: www.bonfiglioliindia.com Brothers Pharmamach (India) Pvt Ltd

12

Pg No

BC

Waters (India) Private Limited

T: +91-11-45457777

T: +91-9867168123

T: +91-80-28371900

E: info@everestblowers.com

E: srane@lmtfette.in

E: waters_india@waters.com

W: www.everestblowers.com

W: www.fette-compacting.com

W: www.waters.com

69

77

Our consistent advertisers

SOURCE PROCESS PLANT MACHINERY & EQUIPMENT @ www.engg-expo.com

94 Modern Pharmaceuticals

December 2010


Modern Pharmaceuticals

December 2010

Modern Pharmaceuticals - December 2010  

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

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