Also available in Sri Lanka, Malaysia, Singapore, Thailand, Taiwan, China & Hong Kong
Draft NPPP 2011: An opportunity gone waste?
he recent announcement of Draft National Pharmaceutical Pricing Policy 2011 (NPPP 2011) evokes mixed response. While on one hand, it is heartening to see an arousal of sorts from the policy paralysis that has been holding the Indian pharma ecosystem for so long, on the other, it raises several questions about its rationale as well as extent of its efficacy in annulling age-old malaises of healthcare in the country.
Before diving deeper into its pros & cons with the ‘essentiality’ criteria for price control, let’s consider some of the salient features of Draft NPPP 2011. On a first look, the content of this draft policy suggests a shift from an archaic ‘Cost-based pricing’ method to a more transparent ‘Market-based pricing’ method. Further, the number of price controlled drugs would rise from 74 at present to 348, thereby accounting for almost three-fifth of the domestic pharma market. Added to this is the consideration that this draft policy proposes ceiling prices only for end-use formulations, based on a weighted average price of top three brands, where the capped prices would be inflation indexed for manufactured goods. Given this, one wonders if this goes against encouraging R&D in pharma space and creating a pragmatic incentive framework for process-improvement, and hence, reduction in costs. Indeed, it would be prudent to have an advanced mechanism to increase price efficiency of pharma products on a sustained basis. This still falls short of the larger challenge in finding ways and means to make adequately available inexpensive non-branded generic drugs in place of expensive branded formulations that are mostly prescribed by doctors.
Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE
Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories
Dr Gopakumar G Nair
In the current socio-economic and healthcare scenario, although India is among the several emerging economies in the world where ‘Drug Price’ remains one of the key factors to ensure accessibility to medicines, such a single-pronged strategy would not do enough to significantly improve access of modern medicines to the common man. With the country’s more than one-third population still living below the poverty line and more than three-quarter of healthcare expenses being ‘out of pocket’, universal healthcare for all would still remain a distant dream. The need of the hour remains a more holistic and comprehensive approach of better access to doctors, diagnostics and hospitals, appropriate financial cover for health along with an effective price regulatory mechanism for medicines.
IPR Consultant & Advisor
Dilip G Shah Chairman, IGPA & Secretary General, IPA
Daara Patel Secretary General, IDMA
Manas R Bastia email@example.com
December 2011 I Modern Pharmaceuticals
In Conversation With T S Jaishankar Managing Director, Quest Life Sciences Pvt Ltd, & Chairman, CIPI (SME)
Pharmacy education in India ........... 27
9 14 20 22 68 69 76 77 91 92
Editorial News, Views & Analysis Technology & Innovation Technology Transfer Projects Event List Book Review Products List of Products List of Advertisers
Automation Trends Pharmacy e ducation ....................................................... 28 Educational policies ....................................................... 30 Interface - Prof T V Narayana ........................................ 34 Roundtable .................................................................... 36
New barcoding regime Advantages and disadvantages for India .....................56 Didier Lacroix, Senior Vice President- Worldwide Sales & Marketing, Cognex Inc
Energy Management Pharma manufacturing units Are they following the best practices? ........................58
Policies & Regulations Facility Visit Ideal Cures Pvt Ltd Providing an ideal cure and beyond
Insight & Outlook
Pharma packaging ................ 41
Diﬀerential pricing Evaluating the pros & cons ........................................60
Strategy Private label products in pharmacy retail Evaluating the pros & cons ........................................62 Rajendra Pratap Gupta, International Healthcare Policy & Retail Expert
Tips & Tricks Pharma manufacturing Compliance tips for GMP..........................................67 Rajendra B Chunodkar, Executive Vice President - Technical, Lupin Ltd
Blister packaging ........................................................... 42 Modiﬁed Atmosphere Packaging .................................... 46
Interface - Ajit Singh...................................................... 50
BioAsia 2012 Advocating lifesciences and providing a global networking platform ...................................................71
Roundtable .................................................................... 52 Biosimilars and biobetters .............................................. 53
Highlights of Next Edition
Details on page no. 26
Special Focus: Lab Equipment/ Analytical Instruments Insight & Outlook : Quality issues (GMP, GLP, etc) Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise
December 2011 I Modern Pharmaceuticals
Event Report API China & INTERPHEX China Autumn 2011 A beacon of win-win pharmerging synergies.............. 72 PMEC & CPhI India 2011 An event full of momentum ....................................... 74 11
FOUNDER & EDITOR, NETWORK 18 Raghav Bahl
GROUP CEO, NETWORK 18 Haresh Chawla
PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan
GROUP COO, NETWORK 18 B Sai Kumar
SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Michael Anthony, Abha Mishra, Paskaline Sebastian, Titash Roy Choudhury (Delhi), Jasleen Kaur Batra (Bengaluru) ASSISTANT ART DIRECTOR Varuna Naik DESIGN Sachin Bhogate CHIEF PHOTOGRAPHER Mexy Xavier PHOTOGRAPHY Neha Mithbawkar, Joshua Navalkar BUSINESS CONTROLLERS Pukha Dhawan, Lovey Fernandes, Akshata Rane, Deepak Bhatia, Shwetha ME, Jayashree N, Sugandha Kulkarni, Shefali Mahant
PRINTING EXECUTIVE VICE PRESIDENT Ananth R Iyer ASSISTANT GENERAL MANAGER - PPC Shekhar Khot
PRODUCTION TEAM Pravin Koyande, Dnyaneshwar Goythale, Vikas Bobhate, Ravikumar Potdar, Ravi Salian, Sanjay Shelar
OVERSEAS CONTACT Ringier Trade Media Ltd
CHINA 1001 Tower 3, Donghai Plaza, 1486 Nanjing Road, West, Shanghai 200040, China Tel: +86-21 6289 – 5533 Ext. 368, Fax: +86-21 6247 – 4855 (Craig Shibinsky) Email: firstname.lastname@example.org Ringier Trade Media Ltd HONG KONG 9/F, Cheong Sun Tower, 118 Wing Lok Street, Sheung Wan, Hong Kong Tel: +852 2369 – 8788 Ext. 21, Fax: +852 2869 – 5919 (Octavia Au-Yeung) Email: email@example.com Ringier Trade Media Ltd TAIWAN Room 3, Fl. 12, No. 303, Chung Ming S. Rd., Taichung, Taiwan Tel: +886-4 2329 – 7318 Ext. 16, Fax: +886-4 2310 – 7167 (Sydney La) Email: firstname.lastname@example.org
Ringier Trade Media Ltd
GERMANY, AUSTRIA, SWITZERLAND Tel: +41-44 734 0472, Fax: +41 44 734 0680 Email: email@example.com USA Tel: (513) 527-8800 Fax: (513) 527-8801 Email: firstname.lastname@example.org
USA Alfredo Domador, 6505 Blue Lagoon Drive, Suite 430 Miami, FL. 33126, USA Tel: (305) 448-6875, Fax: (305) 448-9942
CEO-PUBLISHING, INFOMEDIA 18 Sandeep Khosla EVP-HUMAN RESOURCES Sanjeev Kumar Singh ASSOCIATE VICE PRESIDENT Sudhanva Jategaonkar ADVERTISING SALES Shashin Bhagat (Ahmedabad) email@example.com Mahadev B (Bengaluru) firstname.lastname@example.org Hari Hara Subramaniam (Chennai) email@example.com Prakash N (Coimbatore) firstname.lastname@example.org Rahul Hanchate (Hyderabad) email@example.com Ameya Gokhale (Indore) firstname.lastname@example.org Durgesh Grover (Jaipur) email@example.com Abhik Ghosal (Kolkata) firstname.lastname@example.org Inder Dhingra (Ludhiana) email@example.com Mukesh Yadav (New Delhi) firstname.lastname@example.org Rohit Dass (Pune) email@example.com Chirag Pathak (Vadodara) firstname.lastname@example.org MARKETING TEAM Ganesh Mahale, Prachi Mutha, Varsha Nawathe, Abhay Borkar
NEWSSTAND AND SUBSCRIPTIONS DISTRIBUTION HEAD Sunil Nair DEPUTY GENERAL MANAGER Manoj Palsay SENIOR MANAGER - SUBSCRIPTIONS Sheetal Kotawdekar CO-ORDINATORS Rahul Mankar, Anant Shirke, Sarita Quadros, Chaitali Parkar, Kamlesh Mathkar, Vaibhav Ghavale
SERVICES SUBSCRIPTION SERVICES For subscription queries, write to email@example.com or call +91 22 30034631-34 or toll free 1800 200 1021 PERMISSIONS For subscription to copy or reuse material from Modern Pharmaceuticals, Write to firstname.lastname@example.org • Monthly Issue Price: ` 100 • Annual Subscription: ` 799
Views and opinions expressed in this magazine are not necessarily those of Infomedia 18 Ltd, its publisher and/or editors. We at Infomedia 18 Ltd do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. Infomedia 18 Ltd does not accept the responsibility for any investment or other decision taken by readers on the basis of information provided herein. Infomedia 18 Ltd does not take responsibility for returning unsolicited material sent without due postal stamps for return postage. No part of this magazine can be reproduced without the prior written permission of the publisher. Infomedia 18 Ltd reserves the right to use the information published herein in any manner whatsoever.
Infomedia 18 Ltd is the publishing arm of Network 18.
Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Infomedia 18 Ltd. Senior Editor: Manas R Bastia Printed at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharmaceuticals is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Infomedia 18 Ltd does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition.
December 2011 I Modern Pharmaceuticals
News,Views & Analysis Taiwan-based, Full-Win Technology Co, plans to launch nano-crushing machine in India it is full-ﬁlled with herbs The subsidiary company of materials. The company is Guan Yu, Full-Win Technology planning to launch one new Co, established in 2007 is division for nano-crushing a powdering technology investigation. With its nonresearcher, developer and mesh design, raw materials manufacturer. Its product, nanocan be completely crushed crushing machine is for herbal and no further sieving job products. The machine has will be required. The ﬁbres already been sold in Taiwan and can be completed crushed China for Chinese medicine Yen, Chun Hsia into 0.1 ~ 1 μm on an (herbs), cosmetics, painting and the construction ingredients. Hence, India average, with almost no wastage, keeps is the next step for overseas business because the working space clean, no dust ﬂy or
US-based SOHM acquires Novatrend Medicament drugmaker Novatrend Medicament An American generic pharmaceutical manufacturer SOHM Inc has acquired Pune-based Novatrend Medicament Pvt Ltd, for an undisclosed amount. As per the deal, Novatrend would bring 17 existing products and would introduce 40 new products, which are currently in the pipeline under SOHM. Besides this Novatrend would also bring in its sales network in seven states with
120 established distributors and stockists with revenue expectations of an additional $ 1.5 million to SOHM, Inc during the ﬁscal year 2012. “We believe this acquisition is an important strategic move for SOHM and will bring in a range of dermatology and cosmeceutical products to our product portfolio,” said Shailesh Shah, President & CEO, SOHM Inc.
pollute. It helps customers to upgrade their products/quality to higher end. Said, Yen, Chun Hsia, Director, FullWin Technology Co Ltd, “After years of domestic business, we are now conﬁdent to introduce our machine in India. It is just the beginning for Indian market. Not only for herbs, the machine is also powerful in crushing the ﬁsh scales to get collagen powder, oyster, egg, or shrimp shell to get calcium and chitosan, rice barn for cosmetics, silicon dioxide for painting and construction, etc.”
Lupin to acquire Japan’s I’rom Pharma Lupin Ltd is all set to acquire 100 per cent stake in Tokyo’s I’rom Pharmaceutical Co Ltd (IP). The acquisition will be done through Lupin’s Japanese subsidiary Kyowa Pharmaceutical Industry Co Ltd. “IP’s strong presence in the hospital segment in Japan, through its line of injectable products, is an ideal ﬁt with our existing oral business portfolio in Japan. The acquisition will not only strengthen our presence in the Japanese market but would also provide for a stronger growth footprint in this priority market,” said Vinod Dhawan, President - Asia-Paciﬁc, the Middle East, Africa & Latin America, Lupin. Adding to this Ray Tsunoda, President & Representative Director, Kyowa, said, “The acquisition will help allow Kyowa and IP to leverage their strengths and competencies to create synergies that would augment Lupin’s growth in the Japanese generics market.”
GVK Bio joins hands with centre in Philadelphia
Invida buys business of Shalaks Pharma for ` 100 crore
GVK Biosciences (GVK BIO), a drug discovery research and development organisation, has entered into an alliance with the Moulder Centre for Drug Discovery Research at Temple University, Philadelphia. Announcing the alliance Manni Kantipudi, CEO, GVK Biosciences said, “As part of the collaboration, GVK Bio would be responsible for the target validation, lead identiﬁcation and lead optimisation of small molecules in selected therapeutic areas, including cardiovascular, metabolic and central nervous system disorders.”
Singapore-based biopharmaceutical company Invida Group Pvt Ltd has acquired the dermatology and baby care product brands of Delhi-based Shalaks Pharmaceuticals Pvt Ltd for ` 100 crore. The transaction includes acquisition of trademarks and technical knowhow for the dermatology and baby care portfolio. Invida Group is a three way venture between Quintiles, a pharmaceutical services organisation, Singapore sovereign wealth fund Temasek Holdings and Zuellig Group, a pharmaceutical distribution and supply chain management network in Asia Paciﬁc and has over 3,500 employees across 13 markets with $ 200 million in revenues.
Cole-Parmer conducts workshops on World’s first miniature NMR Spectrometer across the country Cole-Parmer, has announced a revolutionary benchtop NMR spectrometer and conducted workshops across the country. The picoSpin™45 NMR Spectrometer is a 2011 Silver Award winner in the Science & Medical–Diagnostic Aids category, one of twelve categories honoured by the Edison Awards. In order to promote awareness
A glimpse of the workshop
Cole-Parmer associated with the Oxford College of Science, Bengaluru. More than 450 attendees across the country witnessed the world’s ﬁrst miniature NMR in action. It also included more than 250 students and faculty from the Oxford College and surrounding colleges.
Modern Pharmaceuticals I December 2011
News,Views & Analysis AB SCIEX acquires Labindia’s mass spectrometry division to broaden presence in India
Dr Reddys’ restores operations at its API facility in Pydibhimavaram
AB SCIEX-a global leader in life science analytical technologies has acquired the mass spectrometry business of Labindia Instruments Pvt Ltd. This acquisition was done to increase their focus in India. The transition of this business would include customer relationships, personnel and application support facilities and is expected Umesh Pawa to create new opportunities for customer interactions, collaborations and innovation. “Expansion of AB SCIEXs’ commercial operations strengthens our position in India, building on the success of Labindia’s mass spectrometry business and executing on our growth strategy,” said Umesh Pawa, Managing Director, AB SCIEX India. “By integrating Indian sales, service and support functions into AB SCIEX’s global resources and operational excellence, we will be able to simplify the process for customers to do business with AB SCIEX, drive the highest standard of customer support, and engage in a new level of dialogue with Indian scientists, who are among the leaders pushing the limits to improve life in this region,” he added.
Dr Reddys’ has recently announced the restoration of operations and a return to normalcy at its API manufacturing facility in Pydibhimavaram, Srikakulam district, Andhra Pradesh. On November 8, 2011, the contractors as well as the contract workers came to an agreement in course of discussions facilitated by government oﬃcials to call oﬀ the strike. Subsequently the contract workers started agitations once again disrupting the operations citing lack of clarity on the number of contract workers who would be employed by the company based on its shift requirements. Further, two successful discussions took place between the company management and a mid point was reached on to engage contract workers as per the shift requirement. Consequently, the contract workers discontinued the agitation and have resumed work basis requirement.
December 2011 I Modern Pharmaceuticals
Ozone collaborates with Japanese Company Koboyashi Ozone Pharmaceuticals Ltd has entered into pain management therapy by collaborating with a Japanese company named Koboyashi Pharmaceutical Co Ltd to bring about a series of air activated heat packs for therapeutic relief. This is the ﬁrst time that the heating pads for pain management would be introduced in India by any company. Ozone has been getting into innovative medical products. Last year it had announced its entry into calcium dobisulate innovation for treating cataracts for which the company has already reached the second stage of patenting.
News,Views & Analysis Vivimed acquires Uquifa Spain and Uquifa Mexico Vivimed Labs Ltd has announced the acquisition of Uquifa, a 75-yearold manufacturer of pharma APIs and intermediates with operations in Spain and Mexico. In a move to bring in strategic growth into its product mix and expand the footprint in Europe and the Americas, Vivimed Labs has taken a measured stride with the acquisition of Uquifa Spain and Uquifa Mexico. The acquisition has been ﬁnanced by a balanced mix of debt and equity funds. The investment consideration of $ 55 million is
paid by equity infusion of $ 20 million, debt ﬁnancing of $ 25 million and the balance of $ 10 million by way of deferred payment. This well considered move would strengthen Vivimed Labs current position in pharma APIs and intermediates while signiﬁcantly improving the cost competiveness of Uquifa. While Uquifa gets the supply side eﬃciencies and knowledge base of Vivimed in pharma, Vivimed would leverage the preeminent position of Uquifa in APIs and their robust pipeline of ﬁlings
Advinus’ GK-activator achieves early POC for diabetes Advinus Therapeutics, has completed a 14-day Proof of Concept (POC) study in 60 type II diabetic patients on its lead molecule, GKM-001, a glucokinase activator. The clinical trials on GKM-001 validate the company’s pre-clinical hypothesis that a liver selective glucokinase activator would not cause hypoglycemia (very low blood sugar), while showing
robust eﬃcacy. “GKM-001 is diﬀerentiated from most other GK molecules, due to its novel liver selective mechanism of action. It has a prolonged pharmacological eﬀect and a half-life that should support a once a day dosing as both mono and combination therapy,” said Dr Rashmi Barbhaiya, MD & CEO, Advinus Therapeutics.
Strides receives USFDA approval for two cancer drugs Drug ﬁrm Onco Therapies Ltd, a unit of Strides Arcolab, has received US FDA approval for marketing injectable carboplatin and tentative approval for marketing oxaliplatin USP for injections. Carboplatin injections are indicated for the initial treatment of advanced ovarian cancer, while oxaliplatin would be used to treat advanced cancer of the colon and rectum. According
to IMS data, the US market for generic carboplatin is worth nearly $ 35 million, while it stands at about $ 1.4 billion for oxaliplatin. Strides has also received a nod for marketing carboplatin injections in strengths of 10 mg/ml (aqueous solution),packaged in 1,000 mg/100 ml pharmacy bulk packages. In addition, it has tentative approval for marketing oxaliplatin in 50-mg and 100-mg single-use vials.
to accelerate growth across Europe and the Americas in the next ﬁve years. Commenting on the Uquifa acquisition, Santosh Varalwar, Managing Director, Vivimed Labs Ltd, said, “Multi- geographical locations spell stability and cement long term relationships with customers and channel partners. Uquifa’s preeminent position in APIs, combined with Vivimed’s supply chain eﬃciencies means enhanced competitiveness for Uquifa and swifter broadening of customer base.”
TCG collaborates with JSW in the area of CNS TCG Lifesciences Ltd (TCGLS) a contract research services, clinical research, and laboratory informatics company with operations in India, Europe, Japan, and the US has entered into an agreement with JSW Lifesciences ( JSW), a full services EU based CRO, to strengthen its R&D oﬀerings in the area of central nervous system (CNS) disorders. This agreement will enable TCGLS and JSW to oﬀer specialised preclinical and early clinical development services in the neuroscience domain to their combined customer base. Swapan Bhattacharya, MD, TCGLS said, “TCGLS is pleased to partner with JSW to advance its expertise in the area of CNS and deliver innovative preclinical and early clinical development R&D solutions. This collaboration will add a new dimension to TCGLSs’ present oﬀerings in the integrated drug discovery domain.”Dr Manfred Windisch, CEO, JSW Lifesciences, said, “Partnering with TCGLS gives us the opportunity to take advantage of ‘India beneﬁt’ and work closely for mutual growth. Most important for us is the outstanding quality and the expertise of our partner. We are conﬁdent that this strategic tie-up will be highly beneﬁcial to both.”
First ten quality standards in New Medicines Compendium finalised Oﬀering a new vehicle for improving medicines quality around the world, the United States Pharmacopeial Convention (USP) recently published the ﬁrst 10 standards for the USP Medicines Compendium (MC) at www.usp-mc.org. The newly authorised quality standards— approved by USP’s Council of Experts— are for medicines used as anti-HIV agents, antivirals, analgesics, oral contraceptives
and anti-parasitic treatments. The MC is a free, online source of public standards that help ensure the quality of chemical and biological medicines. Roger L Williams, MD & CEO, USP, said, “Approval of these initial MC standards is an example of USP’s commitment to the improvement of global public health. Intended for use by manufacturers, regulators, pharmacopoeias and others worldwide, the MC provides
rigorous quality assurance measures for medicines where they otherwise might not exist. It is through the availability of public standards such as those developed for the MC that manufacturers of a given medicine or ingredient can meet the same fundamental requirements, allowing practitioners to have conﬁdence in the medicines they prescribe and patients in the medicines they take.”
Modern Pharmaceuticals I December 2011
News,Views & Analysis Glenmark forays into the cosmeceutical segment with Canadian IDC Glenmark has announced its foray into the cosmeceutical segment in India with the launch of Canadian company ImmanenceIDC’s anti-ageing product line in the country. The world leader in dermatology has formed a new division, Glenmark CosmoCare. “Our foray into cosmeceuticals will signiﬁcantly enhance Glenmark’s dermatology product oﬀerings and will further consolidate our leadership position in the segment. IDC products are based on strong scientiﬁc foundation and we are proud to oﬀer the
advanced cosmeceutical line to our wide network of cosmetologists and dermatologists across the country,” said, Rajeev Sibal, Senior Vice-President, Glenmark Pharmaceuticals. These range of products would not be OTC. The IDC line will be available at clinics of leading cosmetologists and dermatologists in around 30 cities, he said. Glenmark has entered into a ten-year agreement with ImmanenceIDC to distribute the former’s high-end dermatology products in eight countries - India, Brazil, Mexico, South Africa, Egypt, Vietnam,
Malaysia and Thailand. It plans to roll out the range in most of these markets by end of FY 12. Through the new division, we aim to be a leading player in the cosmeceutical space in India, Sibal said. “Although the Indian cosmeceutical market has been witnessing strong growth, the skincare segment is still at a nascent stage. We see a great opportunity for IDC’s sophisticated anti-ageing cosmeceutical products in India,” said Eric Dupoint, Chairman, ImmanenceIDC. Also present at the launch was renowned cosmetologist, Dr Malavika Kohli.
Yakult India Microbiota and Probiotic Science Foundation formed in India
Honeywell celebrates10-year alliance to manufacture pharma packaging
With growing interest in the area of Probiotics worldwide and in India, a group of eminent Indian scientists have set up the Yakult India Microbiota and Probiotic Science Foundation with the primary objective of providing a thrust to the ﬁeld of probiotics in the country. The foundation will channelise international knowledge and expertise in the ﬁeld of probiotics and will promote collaborative research in the development of probiotics as well as foster and maintain research links with scientists of similar interest. The foundation aims to provide a common scientiﬁc platform for basic scientists and clinicians to share and exchange knowledge and views and delve into newer areas of probiotic research. It endeavours to do this through an annual Probiotic Symposium, which will blend fundamental and applied research related to the use of probiotics for the enhancement of human health. The proceedings of the symposium will be published in the form of a book with an ISBN number.
Honeywell recently announced the 10t anniversary of the company’s partnership with ACG-Pharmapack for converting Honeywell Aclar® ﬁlm into high-value pharmaceutical packaging. Under the partnership, Honeywell provides Aclar ﬁlms to ACG, and ACG laminates those ﬁlms with other plastics, including PVC and PETG, to create thermoformable pharmaceutical packaging such as blister packaging, for pharmaceutical companies in India. “Honeywell’s technological expertise and innovation in barrier ﬁlms, combined with ACG’s
large customer base in India, have allowed us to serve a wide variety of customers with thermoformable packaging ﬁlms,”said David Barker, Global Marketing Manager, Honeywell’s Healthcare and Packaging Business. “We value our relationship with ACG Worldwide and are pleased to announce this signiﬁcant milestone.” “The Honeywell-ACG partnership has contributed to the growth of ACG, and it has allowed us to introduce several new and innovative products for our customers,” said Michael Franklin, CEO, ACG-Pharmapack.
Goose leads track & trace solutions pack Goose indigenously developed B2B track and trace solution tracker has announced three new customer wins with pharma major companies - Strides Arcolab, Indoco Remedies and Macleods Pharmaceuticals choosing Goose Tracker solution. These three customers will deploy Goose Tracker to generate 150 plus million unique numbers per year for tertiary, secondary and primary packages. Goose expects the deadlines for implementing secondary and primary packaging will accelerate additional customer acquisitions and hopes to
add few more customers in the coming months. Goose Tracker is a software solution that creates, manages and tracks unique serial numbers that are printed on the tertiary, primary and secondary packages. This solution help stem the growing threat of counterfeit prescription
medications thereby enhancing customer safety and conﬁdence throughout product supply chain. Deb Pattnaik, Founder & CEO, Goose, said, “We hope to continue this customer acquisition momentum in the industry, as a number of customers have shown keen interest to adopt Goose Tracker given its ease of adoption, scalability and performance capability. Tracker features robust encrypted serialisation and package authentication capability, designed to ensure consumer safety, reduce counterfeiting and diversion of product.”
Contributed by: Arshia Khan, Chandreyee Bhaumik, Parita Dholakia, Titash Roy Choudhury & Jasleen Batra
Modern Pharmaceuticals I December 2011
Technology & Innovation Novozymes Biopharma supplies R-Tech Ueno with Albucult® for use in unique dry eye therapy Novozymes Biopharma has announced that its recombinant human albumin, Albucult, has been selected by R-Tech Ueno for use in a unique treatment for dry eye syndrome. The company will utilise Albucult as a key component in its new therapy, which will be the ﬁrst of its kind developed for the treatment of severe and moderate dry eye conditions. Dermot Pearson, Marketing Director, Novozymes Biopharma, said, “The partnership demonstrates our commitment to supplying customers with quality biomaterials that reduce operational and regulatory complexity and minimize manufacturing risk.”
New technology to monitor crystal formation Researchers at the University of Leeds have invented a new technology that could come handy to the pharmaceutical industry as it would help them control crystal formation during the process of drug development. Pharmaceuticals often come in the crystalline forms and undetected ﬂuctuations in the system can change the crystal structure which is not what the pharmaceutical manufacturers’ desire. Chance of any sort in the structure is capable of a threat to the safety and eﬃcacy of the product and might also delay in getting the drug to the market on time, which could earn the pharmaceutical manufacturer considerable cost. However, given that drug molecules are growing more complex, the challenges involved in processing them means that it is diﬃcult to always obtain the desired outcome. According to Dr Robert Hammond, Head Research, “Here comes into play the potential of their technology. It makes possible monitoring of the crystals during their formation inside reactor, a phenomenon that was not thought of before. The technology uses powder X-ray diﬀ raction, which monitors the crystal structure while the crystalline form passes through a temperature controlled ﬂow cell. This technology can be developed to work at manufacturing plant scales and can be utilised in specialty chemical industries as well.”
Accela - Breakthrough technology to increase laboratory productivity by Thermo Fisher Thermo Fisher Scientiﬁc has recently introduced two new solvent delivery systems-Accela 600 HPLC and Accela 1000 U-HPLC. These systems enable rapid method development, reduce solvent consumption and consequently, enhance laboratory eﬃciency. These Accela systems’ Force Feedback Control (FFC) features render accurate and precise gradients under all operating conditions and ﬂexibility to quaternary solvent delivery. The Accela PDA improves sample identiﬁcation with increased sensitivity and has an acquisition rate up to 80 Hz. The PDAs’ LightPipe technology allows fast separations by employing a 1 cm path length in a 2 μL ﬂow cell. The low level of dispersion in the LightPipe technology allows the ﬂowcell to retain peak shape and chromatographic resolution. The Accela U-HPLC system optimises the performance of sub-2 μm particle columns. Used with Thermo Scientiﬁc Hypersil columns packed with 5, 3 and the new 2.4 μ particle diameter, the Accela 600 provides ﬂow rates up to 5 mL/min and a maximum operating pressure of 600 bar with 90 μL of delay volume. The Accela 1000 has a maximum operating pressure of 1000 bar with 65 μL of delay volume.
New particle counter extends scope of lab monitoring IKS International has recently added airborne particles to the parameters that can be monitored by their market-leading XiltriX® real-time laboratory monitoring system. Each calypso particle data transmitter can support up to ten particle counters for continuous, automatic particle counting in clean rooms, IVF laboratories, pharmaceutical production facilities and anywhere that airborne particulates are a potential problem. They are available to a number of speciﬁcations,
but can typically monitor particles down to 0.3 μ in diameter. About 0.5 μ and 5 μ particles are counted simultaneously,
accumulating counts over a minute as ambient air ﬂows through the counter at a rate of 1 cubic foot/min. The accumulated particle count is transmitted digitally to XiltriX for logging and reporting. This system ensures no data losses due to signal transmission or conversion. XiltriX also continuously monitors the airﬂow through the counter and its operational status, thus providing traceable, real-time data that will greatly assist compliance with GMP and similar quality protocols.
Modern Pharmaceuticals I December 2011
Technology Offered As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration. 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 the American market. Areas of application Pharmaceutical industry Forms of transfer Equipment supply 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
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
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
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
Filter cleaning system An Indian company offers an automatic
Technology Requested IV fluid manufacturing as SME An Indian company needs new and good technology to start manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others Disposable Syringes An Indian company is interested in cost-effective production line for disposable syringes for both ribbon and blister options.
Areas of application Medical industry Forms of transfer Others Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals,
removing sediments from waterways, biogas, microbiology detector. Areas of application Biotechnology, engineering Forms of transfer Consultancy 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
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: email@example.com, 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.
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 Limited, â€˜Aâ€™ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4679 Fax: 022-3003 4499 Email: firstname.lastname@example.org
Modern Pharmaceuticals I December 2011
T SConversation In Jaishankar With: T S Jaishankar
‘Drug discovery is constantly observing tremendous growth’ …says T S Jaishankar Managing Director, Quest Life Sciences Pvt Ltd, & Chairman, Confederation of Indian Pharma Indiustry (SME). He divulges what got him interested in the pharma sector and highlights the way ahead for the industry. Chandreyee Bhaumik
Modern Modern Pharmaceuticals Pharmaceuticals I December 2011
T S Jaishankar The latest trends and opportunities in the pharma sector. The pharma industry has been witnessing tremendous growth in the last few years. In fact, I believe that even inﬂation cannot aﬀect this industry. Further, drug discovery is constantly observing tremendous growth. There have been new diseases and these are creating opportunities and avenues for the pharma industry. With passing time there has to be more emphasis on clinical research because this is a fastest growing segment, especially, compared to the manufacturing segment. In manufacturing there is competition and gradually the margins become slim, especially for generics. It must be noted that the process of new drug discovery is an expensive aﬀair and requires domain knowledge. Therefore, in the pharma industry clinical research segment has more opportunities and scope.
Why did you choose the pharma industry? I am an honours graduate in chemistry from the Royal Institute of Sciences and
Involvement with the pharma industry Chairman of the Confederation of Indian Pharmaceutical Industry (SME) known as CIPI, a national body of SME pharma manufacturers all over India, having membership of nearly 3000 pharma manufacturers in India Invited by the Chamber of Commerce, Luxemburg to present India’s achievements in the pharmaceutical industry Represented CIPI at the economic advisory board meeting of the Government of India to arrive at a consensus on the Draft National Pharma Policy in India Spoke at several forums including Chamber of Commerce, Brazil, Cuba, and Columbia and more recently in Pakistan Has several publications to his credit and has participated as a speaker at National and International Forum
December 2011 I Modern Pharmaceuticals
have done my Post Graduate Diploma in Business Management. After working brieﬂy in Haﬀkine Institute, Mumbai, I got an opportunity to work with the Berne, Switzerland in the Swiss Red Cross in the manufacturing of bio pharmaceuticals mainly human blood plasma protein fraction such as immunoglobulins, albumin, etc. The education ﬁeld has always fascinated me. I had got the opportunity to teach also and I personally believe it is always interesting to teach what one has learnt. However, at the time when I was working, academics were at a low key and thereby I never took part in academics.
The investment pattern required for the industry. The appropriate investment for the industry would be $ 10 million or in terms of Indian currency it would be ` 50 crore. And as far as the Return on Investment (ROI) is concerned, the ideal payback period should be 3-4 years. Thus, the average growth of the industry would be 10-15 per cent annually.
Brain drain Practically, if you consider today’s situation it is working in opposite direction. Now, it is the age for reverse brain drain. Compared to the earlier times, though people are pursuing their education and research activities they are coming back to India. In fact, they are quite aware of the fact that there are a lot of opportunities awaiting them in the country.
Views on the research opportunities in India Even today, in our country, research is at an infant stage. However, there are good possibilities of R&D ﬂourishing here. It can be said that India has large companies that are likely to come up with drug discovery. Further, the smaller companies would come up with stages of phase I trials and sell oﬀ to the larger companies.
What strategies should the Indian pharma industry adopt to witness further growth? Indian
Oﬀ track Recent read: John Grisham’s ‘The Partner’ Last watched movie: Mission Impossible II Favourite actor: Clint Eastwood and George Clooney Favourite politicians: I hate all of them! marketing to at least to 50-60 markets globally. Further, a challenge in terms of Chinese competition, especially in terms of formulations, is gradually building up. We should concentrate on this segment and see that we do not lag behind the other countries in this context. Next, the young generation should start exploring prospects and options in the clinical research segment along with drug discovery and new formulation technology. Also, for the pharma education sector, there should be inclusion of internship programmes like that in the healthcare segment, and it should be in the specialised segments, such as internship in marketing or drug discovery and many others. The students after their M. Pharm can pursue such programmes. This will provide them with a hands-on job opportunity and they will have an edge over others in the competitive ﬁeld.
Expected trends As mentioned earlier pharma industry looks promising and is expected to witness smart growth prospects. Several MNCs are coming to India, facilitating a plethora of opportunities for the pharma companies here. Therefore, with time, M&As are going to become more common. Additionally, regulations are becoming stricter. Thus, the industry will become globally competitive. In this scenario, medium sized companies will become large and others (especially the smaller ones) will ﬁnd it extremely diﬃcult to survive. In the time of M&As, the pharma companies will either grow or perish. (email@example.com)
Pharmacy education in India Pharmacy education Need for 3600changes in syllabus ............................................................. 28 Educational policies High time for amendments .................................................................... 30 Interface Prof T V Narayana Honorary Secretary - The Indian Pharmaceutical Association (Education Division) and Central Council member of Pharmacy Council of India ..................................................................... 34 Roundtable Pharmacist licence dilemma: B Pharm or D Pharm? ................................ 36
December 2011 I Modern Pharmaceuticals
Special Focus: Pharmacy education
Need for 3600 changes in syllabus The curriculum of pharmacy education in India needs a closer look since efforts are being taken to refurbish the existing one by incorporating newer concepts and courses with the aim to create world class pharmacists. But the question is, is it feasible and practicable? Titash Roy Choudhury
ith growing demands for more proﬁcient and smart pharmacists all over the world, Indian pharmacists are lagging behind with their lack of skills and less focus on patients. The present syllabus structure hardly gives scope for developing skills to handle patients or any knowledge about the healthcare sector. But not anymore; understanding the need of the market a new course has been introduced in pharmacy education in India that would help Indian
pharmacists achieve world standards. Earlier the curriculum of pharmacy education was blamed for being more industry oriented than patient oriented and the concept of providing pharmaceutical care was missing in the syllabus. But things have changed from 2008 when a new course called PharmD was introduced.
Role of pharmacists in India The point to be noted is that there is no uniform syllabus for pharma education in this country. Firstly, “The institutions imparting pharmacy education are aﬃliated to the medical university or technical university,
whereas the standards and norms for running the institute are prescribed by All India Council for Technical Education (AICTE). The Pharmacy Council of India (PCI), the statutory body of the profession, derives satisfaction in being a silent spectator and as a member of other bodies governing the pharmacy profession, rather than amending the Pharmacy Act broaden the objectives and functioning of the council,” says S R Duggal, Chairman, Institute of Clinical Research (India) (ICRI). Diﬀerent institutions have their own syllabus and the change and modiﬁcations also diﬀer within colleges. “There is no uniform syllabus for pharmacy in India however during the four years of B Pharm course around 32 to 36 subjects are covered which are from the core subjects of pharmacology, pharmaceutics, pharmachemistry and pharmacogonosy,” says Professor B P Srinivasan, Director, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR). According to a paper written by Subal C Basak, MPharm and Dondeti Sathyanarayana, PhD and published in American Journal of Pharmaceutical Education, “The basic pharmacy courses of the programme consist of mostly old and outdated concepts with many unnecessary topics that are of little practical value.” The present curriculum of pharmacy education in India “is generalised broad based syllabus, which prepares students for academia, industry and hospital. However, the syllabus is not tailor made for the needs of industry and hospital,” says Prof Srinivasan who also thinks that the current curriculum is not suﬃcient to meet global standards for pharmacist. Due to the lack of patient-oriented approach in society, a pharmacist has no public image. “In hospitals, pharmacists are still serving as compounders rather than counselors. Pharmacists do not play any useful role in the healthcare of the country. Even the new Health Policy of the Government of India (2002) has not recognised the services of pharmacist,” says Duggal. The role of pharmacists in the entire healthcare sector is not well deﬁned as per Pharmacy Act; the pharmacist is involved in dispensing/delivery of drugs to the patient. “They are not getting the due respect from the patients as the patients do not pursue
Modern Pharmaceuticals I December 2011
Pharmacists are not getting the due respect from the patients as the patients do not pursue them and consider them incapable of giving enough in terms of healthcare.
All the faculty members should update their skills and should make the students aware of the cutting-edge research areas during the teaching process. S R Duggal Chairman, Institute of Clinical Research (India)
them and consider them incapable of giving enough in terms of healthcare. They can get more respect in the society and healthcare team provided they give pharmaceutical care and counselling to the patients. Hence, there is a need to modify the syllabus keeping in view the healthcare delivery to the patient,” believes Prof Srinivasan. In 2008, the 6-year PharmD and 3-year post-baccalaureate PharmD was introduced, which would focus on clinical practice and the role of pharmacists in providing pharmaceutical care to the patients. The ﬁrst batch in post- baccalaureate passed out this year while the ﬁrst graduation course is yet to pass out.
Industry or patient oriented? According to a paper by Basak and Sathyanarayan ‘the orientation of the pharmacist has changed from the product to the patient. The expansion of the role of pharmacists received an important boost in 1990, when Helper and Strand coined the term pharmaceutical care. Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving deﬁnite outcomes that improve the patient’s quality of life.” But our curriculum is industry and product oriented rather than being patient-oriented. With an increasing disease burden pharmacists need to be trained in handling patients and for doing that proper knowledge of healthcare and patient care is required. Also, development of soft skills of pharmacists will help in patient care. In developed countries, pharmacy curriculum (undergraduate) gives more emphasis to patient care and students spend considerable time in the community or in the hospital pharmacy. They acquire good knowledge of anatomy and physiology, biochemistry, pharmacology and toxicology, clinical data
December 2011 I Modern Pharmaceuticals
Professor B P Srinivasan Director, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR)
analysis, pathophysiology, drug information and interactions and social pharmacy. This kind of knowledge and skill enhancement prepares the graduates to practice conﬁdently in the community and in the hospital setting. They also have the advantage of interacting with other healthcare professionals. “Course chart of educational institutions is not contemporary because of which knowledge of graduates has become outdated and is not eﬀectively utilised. More value should be given to projects/assignments, conceptual and practical approaches of teaching so that students can spend more time on understanding the subject and develop speciﬁc skills. Involvement of industry experts in framing the syllabus is yet another way to get updated with industrial developments,” says Duggal. Understanding the gravity of the situation and growing market demands PharmD program, which focuses on the clinical practice and preparing them for community practice, was introduced. But according to Basak and Sathyanarayan’s paper ‘A detailed evaluation of the PharmD curriculum’ has shown that the basic science, chemistry, and pharmacy subjects are an extension of the existing D Pharm and B Pharm programmes. Although the curriculum emphasises the clinical and patient-oriented aspects of the profession, it overemphasises basic sciences (such as chemistry and analysis), while subjects such as pharmaceutics and health policy have been overlooked.” The launching of the PharmD programme in India has sparked an enormous amount of debate among educators and policymakers. The paper speculates how ‘The introduction of the PharmD programme may not help clinical pharmacy education and practice in India’. Besides, Apprehensions have been raised
regarding inadequacies within the PharmD curriculum, unclear professional advantage over the current D Pharm programme as a professional degree and promotion of the PharmD degree to gain international status and provide pharmacists for the US.” But keeping the speculations on one side we should not overlook the eﬀorts to bring about a paradigm shift in the curriculum of pharmacy education in India. But there is still a wide gap between academic and industrial research. “Our syllabus should cater to the industry needs. There is a need of involving industrial expertise in the boards of studies.The syllabus should be more application oriented. All the faculty members should update their skills and should make the students aware of the cutting-edge research areas during the teaching process,” recommends Duggal.
Continuing Pharmacy Education (CPE) Similar to the concept of Continuing Medical Education (CME) where doctors and other healthcare professionals undergo training and enhance their knowledge of their respective ﬁelds., encountering the huge growth in the pharma market the profession of pharmacy is also in the need of something similar. CPE is something that Indian pharma market desperately requires but no concrete decision on that front has been taken yet. “The profession of pharmacy has been forced to undergo radical process of evolution with great shift in its public mission. Hence, it becomes clear that pharmacy education also needs to react and undergo rapid changes, renewing the terms of graduate professional in strengthening healthcare system in order to keep pace with emerging trends in pharmacy ﬁeld,” opines Duggal. (firstname.lastname@example.org)
Special Focus: Educational policies
High time for amendments Pharmacy education in India has been going through a tough time with no amendments happening while the pharma industry is progressing at a high rate. The policies that are governing pharmacy education in India need attention and some modifications. Titash Roy Choudhury
harmacy education is a ﬁeld in India that is seldom spoken about or discussed except in conferences or seminars; it remains the last of the choices for students to pursue while deciding higher education. The availability of vast technical pool, skilled manpower, well-established stateof-the-art manufacturing plants, has made the Indian pharma industry a global pharma destination. And with this growth we have seen mushrooming of private pharmacy colleges all over the world but has the quality improved? “Pharmacy education in the country is passing through a diﬃcult phase. According to experts, in pharmacy education all the states across the nation almost 25 to 35 per cent seats for undergraduates (UG)
training programme for B Pharm are unoccupied,” says Dr P G Yeole, President, Association of Pharmaceutical Teachers of India. And this is not restricted to undergraduate course but also extends to post-graduate (PG) courses. It is surprising to note that nationwide there are 1,000 plus pharmacy colleges out of which 500 came into existence during the past few years! And for courses like M Pharm also the scenario is becoming worse, “They are infact ‘mushrooming’ with around same number of seats dedicated for M Pharm students, which is supposed to be classiﬁed as a specialisation. As per the current norms of the All India Council for Technical Education (AICTE), an educational institution can directly commence PG courses. This suggests that M Pharm courses might also reach a level of saturation. No doubt it has added
manpower availability in the country,” believes Dr Yeole. There are several other reasons for the waning popularity of pharmacy profession in the country. The standard of pharmacy education has been deteriorating due to lack of qualiﬁed & well-trained staﬀ and even infrastructure. So there is an urgent need to initiate an administrative and academic exercise to bring changes and reforms keeping in pace with current and emerging trends in ﬁeld of pharmacy.
The policies and regulations scenario There is no speciﬁc policy for regulating the pharmacy syllabus in India. Pharmacy education in India is regulated by two organisations: the Pharmacy Council of India (PCI), under the Pharmacy Act of 1948, and the All India Council for Technical Education (AICTE), which was established under the AICTE Act of 1987. “The PCI regulates the D Pharm programme, it has no jurisdiction over M Pharm and other higher-level degree programmes,” informs Dr Yeole.
Modern Pharmaceuticals I December 2011
Educational policies Final year candidates should undergo internships with the pharmaceutical industry for at least six months. This will ensure close interaction between the candidates and the pharmaceutical companies. Dr Amit Rangnekar General Manager, Centaur Pharmaceuticals PCI makes regulations regarding the minimum standard of education required for qualiﬁcation as a pharmacist. It is responsible for registration of individuals fulﬁlling the prescribed eligibility criteria (minimum D Pharm) and issuing a license permitting them to practice in an Indian state. Thus, the PCI regulates the D Pharm programme and the recently introduced PharmD programme. The B Pharm programme needs to be recognised by the PCI for qualiﬁcations to be accepted for registration purpose only. “Pharmacy education at all levels excluding PharmD is regulated by the AICTE and all these programmes must be approved by it,” informs Dr Yeole. The AICTE is primarily responsible for planning, formulating, and maintaining norms and standards in technical education, which include pharmacy. “The ﬁrst Education Regulation was framed under the Pharmacy Act in 1953 and amended in 1972 and 1981. Currently, the Education Regulation 1991 is in force, which regulates diploma course in pharmacy. Amendments were done just to regulate diploma course in pharmacy. There has been no amendments since long,” says Dr Yeole. Besides the Pharmacy Act, pharmacy practice is also governed by the Drugs and Cosmetics Act of 1940, which stipulates the manufacture, distribution, and sale of drugs. Currently, there is no regulatory body and regulatory control for clinical pharmacy practice. The AICTE is also responsible for quality assurance of pharmacy programmes (D Pharm, B Pharm and M Pharm) through accreditation by National Board of Accreditation (NBA) constituted by the AICTE.
The most important amendments required are: control of the pharma education by one regulating body to remove dichotomy and orientation of the curriculum to fulfill practice requirement and standardisation of curriculum. Dr P G Yeole President, Association of Pharmaceutical Teachers of India
But this is the current scenario where from 1991 there has not been any amendment to the regulations of pharmacy education while the need of amendments is there. “There have been changes in policy, keeping in mind what the industry needs. But with current regulatory requirements being global in nature (USDFA, UKMHRA, TGA), policies should be attuned to suit global standards,” says Dr Amit Rangnekar, General Manager, Centaur Pharmaceuticals. With increasing global standards amendments are mandatory. “The most important amendments required are: control of the pharma education by one regulating body to remove dichotomy and orientation of the curriculum to fulﬁll practice requirement and standardisation of curriculum,” asserts Dr Yeole.
Meeting global standards With globalisation and increased ﬂow of international pharma companies to the Indian market, the need of the hour for Indian pharmacy is to meet the global demands and the current policy governing the education syllabus is not suﬃcient enough to meet them. “The present Indian education system is rigid, it is mostly memory based with great reliance on textbooks and reproducing information on the answer sheets during examination,” avers Dr Yeole. On the other hand, Western universities emphasise on analytical abilities and focus on application of knowledge and skills. Outside India there is a strong industry-academia collaboration, which is a key driver of R&D and innovation, as well as a source of ‘industry ready’
pharmacists and scientists. This needs to be imbibed into our system. “The focus should be on developing a strong skill set coupled with academic rigour and evaluations should be based on successful completion of industry-related projects. Final year candidates should undergo internships (as in the medicine ﬁeld) with the pharmaceutical industry for at least six months. This will ensure close interaction between the candidates and the pharmaceutical companies. This arrangement will allow the candidates to exhibit their passion and acumen, and enable companies to evaluate and select the right candidates,” says Dr Rangnekar. Dr Yeole believes that in the current curriculum training for community pharmacy practice is clearly lacking. “In order to cater to both industrial and healthcare aspect of pharmacy profession, the graduate level courses should be separated as B Pharm – Industrial and B Pharm Healthcare. Our graduates are lacking in skills needed for industry, hospitals or in community setting. This requires curriculum upgradation with relevance to functional performance,” says Dr Yeole. Eﬀorts are being taken by conducting various seminars and experts discussing the requirements, like the PCI, The Indian Pharmaceutical Association (IPA) and leaders of pharmacy profession have undertaken several initiatives including the rolling out of the Charter of Pharma Vision 2020, a roadmap document during 58t IPC 2006 in Mumbai proposing various activities to shape the future of pharmacy profession and pharmaceutical services in India by 2020. (email@example.com)
Modern Pharmaceuticals I December 2011
Special Focus: Interface - Prof T V Narayana
‘Pharmacy education should be regulated under one apex body’ ...advocates Prof TV Narayana, Honorary Secretary of The Indian Pharmaceutical Association (Education Division) and Central Council member of Pharmacy Council of India. Starting his career as a lecturer at an early age of 27 he has spent 24 valuable years in this field and has seen pharmacy education go through numerous changes. He recoomends a few changes that would boost pharmacy education in India. Titash Roy Choudhury What drove you to take this less trodden path? I am from Andhra Pradesh, and there was no private college in Pharmacy at the time when I had decided of taking up pharmacy. So as soon as I completed my Masters degree I looked at the market scenario and saw how teaching could be a viable career option. By being a teacher I could motivate and guide other people to take up this profession. My professors at college further advised and guided me to take up this profession and that is how instead of going into the industry I went for the academics. How has the journey been? I started my career by teaching students interested in community pharmacy before teaching graduates and then post-graduates. At the age of 27 guiding and shaping minds was thrilling and invigorating. The beginning was exciting where I helped my students identify their strength and guide them in making important career decisions. After I started my career I am the youngest fellow to receive fellowship award by IPA and the ﬁrst person from private sector to be the Chairman of Education Division of IPA. Current scenario of pharmacy education in India Globally, pharmacy education is more practice oriented and worldwide a pharmacist along with working in the industry also contributes to the healthcare sector of the country by counselling patients and providing them
all the information on prescribed drugs. When pharmacy was started in 1939 the curriculum was designed primarily to cater to the needs of the industry and we have been successful in meeting the industry demand, which can be seen in the high growth rates of Indian pharma market in the last few years. However, in 2008 India introduced PharmD under which the students are trained in patient counselling and pharmaceutical care. There was no curriculum earlier to look at the clinical practice of pharmacists and looking at the global scenario India introduced this course. Today we have provided two options for the pharmacy students in this country; an industryoriented student can opt for general degree courses of B Pharma and M Pharma, while a practice-oriented student can go for PharmD course. Indian pharmacy education is not lagging behind in any way from the developed nations.
The major roadblocks One of the major problems hampering the growth of pharmacy education in India is the parallel functioning of two apex bodies to regulate pharmacy education in India. Pharmacy education in India is controlled by two diﬀerent regulating bodies’ All India Council for Technical Education (AICTE) and Pharmacy Council of India (PCI). In last two years unfortunately AICTE increased the number of permission to open college from 345 to 1,200 yearly, without considering the demand-supply requirement in respective states. This abnormal increase in number of institutions resulted in poor admission; some college saw only 20 per cent admission in degree courses and seats went vacant since there were not many students to opt for pharmacy courses in India. Pharmacy education should be regulated under one apex body, like in medical profession it is controlled by Medical Council of India (MCI). How do you see pharmacy education developing in the future? Our business is expected to grow to $ 80 billion by 2020. There is a huge requirement for pharmacy professionals for the industry, almost 10 lakh according to McKinsey report. In a developed country a pharmacist has the right to charge for the counselling given to patients but there is no such option for Indian pharmacists till now. That is why PCI is coming up with the Pharmacy Practice Act under which even the Indian pharmacist is going to charge counselling fee. (firstname.lastname@example.org)
Modern Pharmaceuticals I December 2011
Special Focus : Roundtable
Pharmacist licence dilemma: B Pharm or D Pharm? Although the Indian pharma market is experiencing massive growth rates, the role of pharmacists in this country has not undergone any significant changes. With increasing disease burden and growing market demand the question that arises is should we increase the bar for registration of pharmacists from Diploma to degree. Some professors in the field voice their opinions. Titash Roy Choudhury
Dr Navin Sheth Professor & Head, Department of Pharmaceutical Sciences, Saurashtra University
Prof Dipak K Majumdar Professor-Pharmaceutics, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR)
B. Pharm should be the minimum qualiﬁcation for registration as a Pharmacist in the Pharmacy Council (SPC). Increasing number of pharmacy graduates are coming out compared to in 1970 when the Pharmacy Act was implemented.Pharmacist is an important link between a doctor and patient, and a minimum graduate in pharmacy, ie B. Pharm, would be essential. Our healthcare system in its entirety should be at par with other developed countries. It will also generate more employment for pharmacy graduates. B. Pharm graduates have enough knowledge of drugs, their use, abuse and drug-drug interaction compared to D. Pharm. India is one of the biggest suppliers of the drugs in health care system so B. Pharm should be the minimum qualiﬁcation for registration.
If we decide to change the qualiﬁcation to degree many things have to be considered. With increasing patients and disease burden we need to be responsible and cautious in treating them, and having a degree course as the minimum qualiﬁcation to get the pharmacist licence may act as a gateway. But we also need to understand that the percentage of pharmacy students who opt for retail pharmacy in India is low since it is not that lucrative in India. With not many students opting for this ﬁeld increasing the minimum qualiﬁcation to a degree course may adversely aﬀect the number of people going for retail pharmacy. In US, retailers earn more than their counterparts in the industry and once we achieve something similar we can think of setting the bar higher.
Dr D P Pathak Professor-Pharmaceutical Chemistry, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR) This will only be viable when the retail pharmacy ﬁeld becomes more lucrative. Having the cut-oﬀ increased to B. Pharm will not be eﬀective if the retail pharmacy section continues the way it is now since most degree holders will then prefer to go into the industry than for retail pharmacy. Also, in India this gives a job opportunity to people who can ﬁnish a two year diploma course and start their own retail shop. If we increase that to a degree course no one would want to invest six years of their career just to open a pharmacy shop. Retail pharmacy in India is not as developed as other countries and that is why most of the pharmacy students go for the industry. If we take the decision of upgrading the qualiﬁcation criteria to a degree level, retail pharmacy needs to undergo a massive makeover.
Considering the factors that regulate the Indian pharma market such a step needs to be taken gradually. Keeping only market demands in mind will not be enough, and the percentage of students opting for retail pharmacy and how will this step aﬀect them should be noted. This step forward needs to be taken cautiously and after in-depth research.
Modern Pharmaceuticals I December 2011
Facility Visit: Ideal Cures Pvt Ltd
Providing an ideal cure and beyond Knowing the expectations of the customers and providing the required is the biggest challenge of any company, and, if rewarded, is a permanent strategy to follow. Read on to trace the growth path of Ideal Cures, its milestones and the future path. Chandreyee Bhaumik
deal Cures Pvt Ltd, a well-known company in the ﬁeld of tablet coating system, pharmaceutical ﬁlm coatings, ﬁlm coating system for tablets, has established itself, as a reliable source for all pharmaceutical ﬁlm coating needs. Established in 1999 this is a specialty company that focusses on pharma coating. It is an ISO 9001:2001, GMP, Kosher & Halal certiﬁed company, and is committed to on-time supply
for nutraceutical and dietary supplements. Ideal Cures has three state-of-the-art manufacturing plants and are ISO 9001:2008 & WHO cGMP certiﬁed. They are located in India at Vasai (Maharashtra), Bari Brahmana ( Jammu and Kashmir) and at Khambat (Gujarat) along with two modern R&D facilities at Mumbai and Vasai. Highly qualiﬁed and experienced technical teams provide technical support round the clock to its customers. The company has spent a decade in its relentless pursuit of excellence in ﬁnding tailor-made excipients and coating solutions for solid dosage forms.
of the company, Pareek says, “Our vision at Ideal Cures Pvt Ltd is to become a premier ﬁlm coating system and pharma excipients manufacturing company. We envisage not being the biggest, but the best in terms of customer delight and consistency in quality.” Further, while talking about the mission of the company, he says, “The mission of the company is to provide tailor-made coating and excipient solutions.” The brevity of this mission statement may undermine the gravity of its implication. So, Pareek explains how the company lives up to the mission statement. He says that value is added to the customers’ products by developing & delivering technically advanced ﬁlm coating systems and excipients for pharma, herbal and nutraceutical applications, “We constantly upgrade and enhance our employees’ skills and dedication to our customers. We achieve superior quality service and operating performance in our products and continually
Photo by: Neha Mithbawkar
of consistent quality products and services. The dedicated application centre is well equipped to provide customised development and value-added products besides technical assistance for specialised coating applications and training at customers’ premises or at the company’s application laboratories.
Product portfolio The product portfolio comprises INSTACOAT™ ready-to-use ﬁlm coating systems, ECOPOL™ range of pharma acrylic polymers, ESPHERES™ range of sugar, MCC, silicon & calcium carbonate spheres, INSTAMODEL™ range of controlled release products, INSTANUTE™ coating technology
Ideal Cures is primarily into manufacturing of ﬁlm coating systems, pharma polymers and excipients that include cooling compounds, taste-masking agents and many others. Commenting on the diﬀerent departments of the company, Suresh Pareek, Managing Director, Ideal Cures Pvt Ltd, informs, “Out of the various verticals, manufacturing of ﬁlm coating generates maximum revenue.”
Vision and mission In its short life span, by employing adequate transparency in product innovation with relation to cost structure optimisation, the company has gained loyalty from many pharma companies globally. Elaborating on the vision
make improvements and innovations.” He adds that environment friendly ﬁlm coating systems are developed to reduce cost and improve the safety of the customers’ products. He adds, “We act as an extended R&D arm for our customers.” At Ideal Cures, ‘Instacoat Film Coating Systems’ are ready to use and are available in aqueous or organic systems. They can be reconstituted with organic solvent system, aqueous system or hydro-alcoholic system to prepare pharmaceutical solid oral dosage forms. And ‘Instacoat Mask System’ can be used for taste masking of bitter active ingredients used in dry syrups and suspensions. Also, Instabind IC-820, a pharma excipient, acts as a carrier,
Modern Pharmaceuticals I December 2011
Ideal Cures Pvt Ltd bulking agent and disintegrant for direct compression tablets, wet granulation, dry granulation, dry blends and 2-piece capsules.
Journey so far
Our vision at Ideal Cures Pvt Ltd is to become a premier film coating systems and pharma excipients manufacturing company. We envisage not being the biggest, but the best in terms of customer delight and consistency in quality.
Like any entity the journey of this company has been a mix of both good and not-so good times. The primary function of the company starts with the development of the product. Explaining the above point, Pareek says, “We suggest the companies the coating material that is required. Mostly all the pharma companies are our clients. Rather, the question is who is not our client?” However, the journey had never been so smooth. He laments, “The ﬁrst three years was considered to be a tough time. But, we had the belief and the patience to endure it. For many years we have followed the same strategy.” He elaborates that the company had always desired to keep the customers happy by meeting their expectations. He emphasises, “We have always
journey, Pareek elaborates that 2004 was a remarkable year in the history of Ideal Cures. They established their ﬁrst new facility in Vasai. He says, “In fact, 2009 is also quite memorable for us. In this year we had established a facility in Jammu. We can proudly say that we are the only company that has two manufacturing centres for ﬁlm coating in India.” Elaborating on the investments made by the company, Pareek says, “In 2000 we had invested ` 3 crore.
Technology, Government of India. Also, innovation is the life of our company. Right from 2003 we have followed the path of innovation.” At the R&D facility in Vasai, research is carried on ﬁlm coating systems. He clariﬁes, “We conduct research programmes on research on excipients on MUPS as well as pharma polymers. Therefore, we recruit individuals who have done their B Pharm, PhD and also MSc.”
provided quality products and went an extra mile to achieve that. In our company we always remember that we earn our living from the customers and therefore we have to keep them happy.” Talking proudly of the new product line, Pareek says, “This fourth generation ﬁlm coating system will deﬁne the new standards of ﬁlm coating systems. While others have been stumbling to develop and copy the third generation coating system, we are launching Instacoat E Series. It deﬁnitely moves the bar ahead for competition and will likely cause them to go back to the labs yet again.” Discussing several milestones in the company’s
From then onwards, continuous investment has been made. Soon, in two years we had invested almost ` 65 crore.” Discussing the path vested with struggles, he says, “Initially nobody was ready to accept Indian manufacturers. We convinced them that we would add extra value. We in fact oﬀered them the ‘Talk to us’ opportunity. This meant that if one needs service, we will deliver and that too on time.” The market keeps on changing. Thus, in order to live up to the changes, there is a need to constantly invest on R&D. Pareek mentions, “Both our R&D centres are recognised by the Ministry of Science &
December 2011 I Modern Pharmaceuticals
Suresh Pareek Managing Director, Ideal Cures Pvt Ltd
Ideal Cures is one of the leaders in this space. However, the best form of success comes when the company devices strategies to innovate and adopt progressive path. Discussing the success path that needs to be followed, Pareek signs oﬀ saying, “We are certainly the leaders in the industry. Colorcon can be considered as our competitor. As our 5-year plan we aim to create something concrete. We are looking at adding two more manufacturing units - one in Europe and the other in a diﬀerent country. We are aiming at 18-20 per cent Return on Investment (ROI) annually.” (email@example.com)
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,
Manas Bastia Senior Editor Infomedia 18 Limited ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W) Mumbai 400 028 India
D +91 22 3003 4669 T +91 22 3024 5000 F +91 22 3003 4499 E firstname.lastname@example.org W www.infomedia18.in
Insight & Outlook
Pharma packaging Blister packaging Unravelling the popular form .................................................................. 42 ModiďŹ ed Atmosphere Packaging A cost advantage option? ........................................................................ 46 Interface Ajit Singh Chairman, ACG Worldwide ....................................................................... 50 Roundtable Is India at par with the global pharma packaging industry? ........................ 52 Biosimilars and biobetters Unique patenting issues ......................................................................... 54
December 2011 I Modern Pharmaceuticals
Insight & Outlook- Blister packaging
Unravelling the popular form Backed by several benefits, blister packaging has become a popular form in the pharma sector. Read on to find out the pros and cons of this packaging. Chandreyee Bhaumik
ow often have you been fussy over the gift wrapper used for a friend’s gift? The answer is surely more than once. The obsession to wrap up with an attractive paper stems out of the desire to be diﬀerent and more importantly to create a visual appeal. However, packaging, especially in relation to pharma industry, assumes higher signiﬁcance than visual eﬀect. Interestingly, no matter what product, if one looks at its packaging, there is a
material has diﬀerent resistance to each of these elements and will aﬀect the shelf life and the storage conditions of the packaged drugs. Tests are usually carried out during a drug’s development (stability studies) to identify which materials are most suitable. However, factors such as cost diﬀerentiation cannot be ignored. The plastic-forming ﬁlms such as polyvinyl chloride (PVC), polypropylene (PP) and polyester (PET) are thermoformed, and are usually colourless and transparent. However, for childproof packs, or if the drug must be protected from light, forming ﬁlms can also be opaque. Blister packaging uses thick plastic to form a clamshell shape. The plastic allows the packaging to be transparent so that one can see the product through the blister packaging. However, the shape and the thickness of the plastic ensure that the product is well protected. Due to the protectice and visual beneﬁts of plastic blister packaging, it is used to package most electronic and pharma products. In fact, the majority of pharma products are packaged using this method. Blister packagings’ blister cards are not purely cardboard, but are instead a blend of plastic, foil and cardboard. They seal the blister packaging using heat, so an adhesive is formed. This kind of packaging is ideal for lighter weight products or pharma products that need to be sealed individually. Blister packaging is also a cheap option.
The nuances of packaging good chance that the packaging material is made at least partly from plastic. And one of the most popular forms of plastic packaging is called blister packaging, also known as clamshell packaging. Blister packaging is popular because it is the best packaging type to protect the product, and the clamshell shape puts the product in an advantageous position.
Choosing the right material The choice of forming and sealing materials used depends on the degree to which the product needs to be protected from light, heat and moisture. Each
Primarily there are two kinds of blister packaging. One form of blister packaging uses a heat sealing process and the other uses sliding blister cards. The sealing blister packaging is made of plastic and other rigid materials. These are thick and rigid, and these packaging units are beneﬁcial for any product that needs a lot of protection, and it can only endure one use. Pharmaceutical plastic blister packaging is often used in this industry to keep the products safe in transport as well as keep them from being tampered with. One of the main reasons for using plastic blister packaging is to prevent items that
Modern Pharmaceuticals I December 2011
There is primarily one disadvantage of blister packaging. PVC is predominantly used for blister packaging and it is highly permeable.
Blister packaging has its own limitations. There are times when the ﬁlm gets hardened and pinholes are found in packaging. K Subbi Reddy Regional Director, Pharmaceutical Export Promotion Council, Ministry of Commerce & Industry, Government of India are packaged from tampering as well as theft. Blister packaging is a process that can be used with many diﬀerent items to protect them in various ways. Discussing the advantages of blister packaging, K Subbi Reddy, Regional Director, Pharmaceutical Export Promotion Council, Setup by Ministry of Commerce & Industry, Government of India, elaborates, “There are various advantages of blister packaging and one of the primary beneﬁts is the convenience factor. Sometimes, we forget whether we have taken the drug or not. With the type of transparent packaging oﬀered, we can easily ﬁnd out whether we have taken the required dose of the drug. For most of the manufacturers, transparent packaging also becomes cost beneﬁcial.” Further, elaborating on the advantages of blister packaging, Praful Naik, Chief Executive Oﬃcer, Bilcare Research, Bilcare Ltd, says, “Blister package is a unit-dose pack and it is better than a bulk-dose pack. There are various value propositions attached to it.” He explains saying that the later gets exposed to environment moisture more than unit dose pack. As a result there are ample chances of contamination. Exemplifying the above fact he says, “A bottle containing 30 tablets has chance of getting exposed to moisture 30 times. Thus, there are ample chances that when the last tablet from the same bottle is consumed, the tablet has lost all the value.” However, this is not the case for blister packaging. Additionally, according to Naik, transparency gives advantages to this type of packaging. He says, “In an
Praful Naik Chief Executive Oﬃcer, Bilcare Research, Bilcare Ltd
opaque pack it is sometimes seen that in one strip one tablet is missing. However, in a transparent pack everything is visible from outside. It can be easily seen whether each pocket of the strip has one tablet or not.”
On the flip side Indeed, blister packaging is well known and widely used worldwide. With time, blisters are now being used in injectables too. However, it suﬀers cost and nonrecyclability disadvantages. Traditionally, it is manufactured using individual
With time, blisters are now being used in injectables too. However, it suffers cost and non-recyclability
product moulds and high grade PVC and this requires a signiﬁcant investment in equipment. The blister element is heat bonded to the backing card and as a result becomes contaminated with broad ﬁbres, meaning that it cannot be recycled. Therefore, blister packaging has its own constraints. Elaborating on blister packaging, Reddy says, “Blister packaging has its own limitations. There are times when the ﬁlm gets hardened and pinholes are found in packaging. Therefore, the barrier is not
protective. And some of the drugs are moisture prone and it creates problems.” Further, he continues that today blister packaging is not feasible for global use. This is primarily because in cold climatic conditions strict sealing is required and blister packaging does not serve the purpose. He adds, “Thus, we can say that today, blister packaging is suitable cosmeceutically.” Commenting on the ﬂip side of blister packaging, Naik says, “There is primarily one disadvantage of blister packaging. PVC is predominantly used for blister packaging and it is highly permeable. With this type of plastic, moisture can easily go in. And the products when exposed to light and moisture can lose its beneﬁts.” He adds that for this reason nowadays PVDC is used as a barrier polymer. For any type of packaging stability tests are mandatory. Stability tests are required to see whether the packaging material is compatible for the product or not. Reddy emphasises that without proper approach, especially in terms of stability tests, one may land into various problems. Thus, like any other operations, blister packaging has its own pros and cons. However, while commenting on the market scope of this form of packaging, Naik signs oﬀ saying, “The growth of blister packaging is equivalent to the demand of the pharma industry in general.” And since it is less expensive than any other forms this is one of the various favoured forms of packaging. (email@example.com)
Modern Pharmaceuticals I December 2011
Insight & Outlook: Modified Atmospheric Packaging
A cost advantage option? Modified Atmospheric Packaging (MAP) is also known as gas flushing, protective atmosphere packaging or reduced oxygen packaging. The controlled MAP environment helps in having an extended shelf life without requiring the addition of chemical preservatives or stabilisers. A detailed description...
acking products in a modiﬁed atmosphere can oﬀer extended shelf life and improve product presentation in a convenient container, making the product attractive to the end user. According to Hintlian and Hotchkiss, Modiﬁed Atmosphere Packaging (MAP) is deﬁned as ‘the packaging of a perishable product in an atmosphere, which has been modiﬁed so that its composition is other than that of air’. This type of packaging is a requirement in the food and beverages industry too. For example, fats and oils in food can oxidise to make the food turn rancid. One of the main causes of the spoilage of food is the growth of microbes such as bacteria, yeasts and mould that are present all around us. These microbes feed and grow on the food product, causing it to go bad. The appearance of food can also change over time when exposed to air. Fresh meat turns brown after a while because of interactions between oxygen and pigments in the tissue. To package a product in a modiﬁed atmosphere requires sophisticated
machinery to ﬂush out air from the packaging chamber and replace it with a diﬀerent gas or precisely deﬁned mixture of gases, then seal the product in the packaging so that only the modiﬁed atmosphere surrounds the product and not any other unwanted gas. Cuttingedge technologies have been developed to ensure that the gas mixture is the correct one, and to test that once sealed the packages contain the right mixture and do not leak. The type and proportion of gas used in the packaging is largely dictated by the type of product in the package and the sort of decay or change that the product undergoes. The three main gases used in modiﬁed atmosphere packaging are oxygen (O₂), carbon dioxide (CO₂) and nitrogen (N₂). The choice of gas is dependent upon the product that is being packed. Used singly or in combination, these gases are commonly used to balance safe shelf life extension of the product. Additionally, experimental use of carbon monoxide (CO) and sulphur dioxide (SO₂) has also been reported.
Following the need Today, industrial trends drive the need for this form of packaging. This has led to various new techniques for satisfying the customer needs. Elaborating on MAP, Prof C S Purushothaman, Chair Professor & Director, SIES School of Packaging, Packaging Technology Centre, discusses, “The global market for active, controlled and intelligent packaging for food and beverages has increased from $15.5 billion in 2005 to $16.9 billion by the end of 2008. It should reach $23.6 billion by 2013, at a Compounded Annual Growth Rate (CAGR) of 6.9 per cent. Controlled packaging has the largest share of the market; estimated to comprise 45.5 per cent in 2008. Over the last 10 years, there has been a growth of companies with an extremely regional focussed. However, this is still a largely unorganised sector and the concept of robust supply and distribution chain have not truly pervaded the mindsets of budding entrepreneurs.” He further adds, “However, as many start-up companies reach a stable point in their business,
Modern Pharmaceuticals I December 2011
new busIness opportunItIes invites you to
6 - 9 Jan 2012
INDORE Maharaja Shivajirao School Ground, Chimanbaug
10 am - 7 pm
Engineering Expo organised by Infomedia18 is one of the engineering industryâ€™s biggest events in country. The 2010-11 edition of Engineering Expo saw business transactions worth over Rs. 161 crores. Launched in Ahmedabad in the year 2002, the event today boasts of a fabulous visitor turnout. The Expo is a preferred destination for SMEâ€™s and manufacturing & engineering companies to transact, network, tie-up and exchange ideas for the growth of the industry.
Exhibitor Profile Auto & Auto Components | Light & Medium Engineering | Chemicals & Allied Products | Electrical & Electronics | Hydraulics & Pneumatics | IT Products & Services | Automation & Instrumentation | Material Handling Eqpt | Packaging Machinery | Wires & Cables | Machine Tools & Acc. | Pipes & Fitting | Plastics & Polymers | Safety & Security | Process Machinery & Eqpt | Testing & Measuring Instruments Brought to you
Online Media Partners
For Further Details, Call Varsha + 91 98195 52270 Or Email firstname.lastname@example.org
Modified Atmospheric Packaging
Ability to increase the shelf life of the product directly impacts the bottom line of these companies. Under these circumstances, one of the most important methods to improve the shelf life is MAP. Prof C S Purushothaman Chair Professor & Director, SIES School of Packaging, Packaging Technology Centre they start to investigate ways and means to diﬀerentiate themselves in the market by having a fresher product and fewer returns from the shelves. Continuing in this line of thought, he emphasises, “Additionally, ability to increase the shelf life of the product directly impacts the bottom line of these companies. Under these circumstances, one of the most important methods to improve the shelf life is MAP. It will not be surprising to see a growth more that the global rate.” As the name implies, in MAP oxygen has to be modiﬁed in some way. This modiﬁcation is usually combined with a lowered temperature, which means it is a highly eﬀective method of extending the shelf life of a wide range of foodstuﬀ s. Products are generally packed in combinations of the gas trio, with the mix dependent on the physical and chemical properties of the food. MAP is achieved by two ways either vacuum & gas injection (~20 per cent) or gas ﬂushing (~10 per cent). Describing the process in detail, Prof Purushothaman says, “The modiﬁcation process often tries to lower the amount of oxygen moving it from 20 per cent to 0 per cent. This slows down the growth of aerobic organisms and the speed of oxidation reactions. The removed oxygen is replaced with nitrogen, which is commonly acknowledged as an inert gas or carbon dioxide that can lower the pH or inhibit bacterial growth. It would be a fallacy to assume that MAP will just improve the shelf life because MAP eﬀectiveness depends on quality of the basic product, packaging materials, quality of the gas and
December 2011 I Modern Pharmaceuticals
machinery.” He adds that the amount of oxygen above 1-2 per cent can be lead to sub-optimal packs. Above all the manufacturing practice adopted for the operation has to be HACCP approved. Further, he highlights, “There are excellent equipment available for this process and the rest lies with the processor.”
Pros and cons The process of MAP has developed with time and taken new dimensions.
The increase in cost for this technology has to be viewed as an investment when compared to the overall benefit and overall cost reduction.
In 1927 MAP was introduced for the preservation of apples and gradually it has become one of the primary methods of preservation. Elaborating on the advantages of applying MAP Prof Purushothaman avers, “MAP increases shelf life of the product many times. Additionally, MAP decreases the economical losses and also decreases the distribution cost. Thus, it helps to provide high quality products and helps in centralised packing control. Further, it prevents using chemical preservatives and more importantly prevents water loss and cross-
contamination. There is no bad odour and ultimately it improves the shelf life without inclusion of preservatives.” Further, commenting on the visual aspect of the product and its advantages, Prof Purushothaman elaborates, “As MAP products cannot merely be wrapped in ﬁlm - they have to be encased, usually in a tray and therefore retailers have every opportunity to package more attractively. Visual display becomes another key component in MAP’s story of eﬀectiveness.” It is necessary to look into those areas where MAP loses its score. Discussing some of the disadvantages of MAP, Prof Purushothaman says, “It increases the product cost. Further, temperature control is required, wherever necessary and this might create problems. Also, another disadvantage is that diﬀerent gas formulations are required for each type of product. Additionally, the users of this technique need to be educated well so as to do an eﬀective job. And it is required to educate users of MAP about TQM and GMP for best eﬀects.” However, weighing the advantages and the disadvantages, he says, “In short, the slight increase in cost for this technology implementation has to be viewed as an investment when compared to the overall beneﬁt and overall cost reduction.”
Years to come Convenience has always been the buzz word in any industry with consumers on the constant look out for the products having an increased shelf life. Therefore, moderating and maintaining the concerned atmosphere is extremely essential. This is all the more relevant for the pharma industry where maintaining the temperature is not only vital but also mandatory. Therefore, the implied advantages of MAP in addition to increased shelf life is the fact that commodities will get also branded setting up a platform for ﬁerce competition among the manufacturers ultimately beneﬁtting the common consumers. (email@example.com)
Insight & Outlook: Interface - Ajit Singh
‘There is extreme pressure on prices due to competition and also due to government price control’ ...says Ajit Singh, Chairman, ACG Worldwide. He is the founder of the Indian affiliate of the International Society for Pharmaceutical Engineering (ISPE) and the Health Foods & Dietary Supplements Association (HADSA). He is Advisor to the United States Pharmacopoeia for India (USP) and an Expert Member of the Bureau of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP). Chandreyee Bhaumik
the emerging economies of India and China, primarily on account of increasing generics and contract manufacturing activities in these countries. Increasing demand for blister packaging will boost the growth of pharma packaging industry. In emerging economies, more protective packaging is needed due to climatic conditions. However, there is extreme pressure on prices due to competition and also due to government price control. Innovations including childresistant blisters and anti-counterfeit enabled packaging solutions will help pharma companies add value to packaging.
Views on the the pharma packaging industry The Indian pharma packaging industry has come of age and can match some of the best technology in the world in terms of output and features. Latest trends include supply chain security solutions provided by integrated camera inspection systems, high tech, high speed blister cartoning lines and end of line case packing solutions. In addition to this, innovations in barrier packaging ﬁlms have enabled companies in India help the pharma sector move from imported ﬁlms to local sourcing. Trends and opportunities observed Trends in pharma packaging are directed towards convenience packaging and compliance packs. Calendar packs, combo blisters and daily dose blisters are now gaining importance. Estimates from the World Health Organization (WHO) indicate that only 50 per cent of the patients suﬀering from chronic ailments adhere to prescribed recommendations. This is a big concern area and is being addressed by innovative packaging. What is the market share of Indian pharma packaging sector globally? The global pharma packaging sector is a diverse industry and no speciﬁc global ﬁgures are available. However, some sources indicate that during 2011 the pharma packaging industry is expected to grow by 5.9 per cent per annum and is predicted to reach the $ 34 billion mark by the end of the year. Besides the US, Western Europe and Japan, China
is progressing towards becoming one of the leading pharma packaging industry hubs in the world. The Indian sector rides on the strength that it is in a position to provide equipment that meets global standards at aﬀordable prices compared to their European counterparts. Areas of investment The pharma packaging industry in India needs to invest in design capabilities, robotics and high-end automation. Many companies in India have moved in this direction already. With appropriate innovation, there is quick and high return on investment for both, the innovator and the end user. Innovative concepts optimise production with higher outputs and improved quality. How is the industry slated to grow? The market is forecasted to grow at a CAGR of 6.9 per cent reaching a value of $ 68 billion by 2015. The growth is likely to be higher in
Industry in the next 5 years? With more than $ 120 billion worth of drugs going oﬀ-patent in the next 5 years, generic drug manufacturers will emerge as a major segment driving demand for pharma packaging. It should be remembered that originator products’ prices drop substantially when a generic is introduced. Still this market opportunity is substantial. The size of the highly fragmented packaging industry in India is estimated at ` 8,000 crore. The industry is growing at the rate of 22-25 per cent per annum. In the next 5 years, the sector is expected to triple to around $ 60 billion. The large growing middle class, liberalisation and organised retail sector are the catalysts to growth in packaging. More than 80 per cent of the total packaging in India consists of rigid packaging. The remaining 20 per cent includes ﬂexible packaging. With more consumerism and increasing in the reach of the industry into rural India, these ﬁgures will more than surpass the projected growth. (firstname.lastname@example.org)
Modern Pharmaceuticals I December 2011
Growth & challenges faced by the global pharmaceutical industry and those operating in India well as an entire export pallet using high end bar coding mechanism is now being considered as an important tool in ﬁghting drug counterfeiting in India. To this eﬀect, the Directorate General of Foreign Trade of India had issued a notiﬁcation stipulating bar coding on exported medicines, which was going to come into eﬀect from 1st April 2011 later extended to 1st July 2011. However given the technical and ﬁnancial constraints of implementing this new mechanism and pressure from local drug manufactures in India, this stipulated date of 1st July has now been further postponed to October 1st 2011.
The solution offered by Cognex, leaders in machine vision system
he global pharmaceutical packaging industry has witnessed a robust growth in the last few years mainly on the strong demand for pharmaceuticals which is poised to grow at a compounded annual growth rate (CAGR) of around 6.5% during the period 2011 to 2013, according to a research by RNCOS, a leading market research and information analysis company. This immense growth has also lead to the problem of drug counterfeiting which possess a serious threat to the industry as well as consumers. The pharmaceutical industry has witnessed a steady rise in cases of fake, expired, adulterated, or unauthorized medical products reaching consumers resulting in huge losses for pharmaceutical companies through legal litigations from consumers and expensive product recalls. This had led to ‘Track and Trace’ of individual pharmaceutical packages as
December 2011 I Modern Pharmaceuticals
Cognex state of the art In-Sight® Track & Trace solution oﬀers a complete identiﬁcation and data veriﬁcation solution for healthcare serialization. The system works with networked In-Sight vision systems to create a complete identiﬁcation and data veriﬁcation solution for labels on pharmaceutical and medical device packaging and is capable of the following Reads 2D and 1D barcodes: Data Matrix, GS1-128, GS1 DataBar and Pharmacode Veriﬁes correct ID code contents, including compliance with the GS1 Healthcare data standard Provides Data Matrix Mark Quality Assessment during production to detect changes in print quality Veriﬁes the accuracy of printed text Detects label misalignment and skew
Ready for 21 CFR Part 11 Validation Track & Trace provides the technical controls needed for FDA 21 CFR Part 11 validation, including secure user authentication and support for automatic audit trail generation. Plus, the compact, all-in-one In-Sight “smart camera” systems are easier to maintain and validate as
compared to most Windows® PC-based vision systems.
Easy to Integrate, Easy to Use A touch screen friendly user interface makes Cognex’s Track & Trace solution easy to conﬁgure and operate. Companies can integrate the Track & Trace interface into a PC-based HMI or custom application or for a ready-to-deploy solution; Track & Trace can also be controlled using the Cognex VisionView Operator Interface panel or VisionView PC software. Because they are solid state, Cognex’s smart camera vision systems intrinsically provide a more stable platform than Microsoft® Windows®-based alternatives, requiring less maintenance, and fewer service pack updates and patches to install. Being conﬁgurable, rather than programmable, Cognex smart camera vision systems can also make it easier for manufacturers to accommodate future changes in regulations and standards. Moving ahead…. What’s going to be the trend in the pharmaceutical industry? As Indian pharmaceutical manufacturers move from their current traceability initiatives towards compliance with future ePedigree requirements, those that opt to add smart camera vision systems at the machine level will achieve the best balance of price and performance at each application level. And because smart camera vision systems can be combined with a variety of third party products, producers have the ﬂexibility to customize and scale their serialization solutions to best suit their budgets and needs. With the deadline already rescheduled twice in the last one year we will have to wait and see how does the Indian regulator address the needs and problems of SME in the pharmaceutical industry while securing the life of people as well as the brand image - “made in India”. It’s going to be a tough decision to make, one which will witness rapid changes in India’s pharmaceutical sector.
Insight & Outlook: Roundtable
Is India at par with the global pharma packaging industry? While some experts are of the opinion that India is at par with the global pharma packaging sector, others consider that further investments in technology will deliver better productivity. Read on... Chandreyee Bhaumik
Aditya Parulkar Chief Executive Officer Penta Freight Pvt Ltd
Daryll Mascarenhas General Manager, Supply Chain, GlaxoSmithKline Pharmaceuticals Ltd
In order to judge a particular situation, it is mandatory to address the issues beneath. For the pharma packaging industry to develop and witness the similar growth as other countries, technology needs to pick pace. Unfortunately, manpower is still very cheap in our country. Thus, the country relies on manual work, as compared to the inclusion of technology in pharma packaging. Adequate investment along with the change in the mindset of the industry is also required for change. On the other hand, the West has progressed to recyclable and reusable technology for packaging. It is sad but true that in the name of cost advantage, even today, we are jeopardising the safety of the people. Therefore, advanced technology should be employed so that pharma packaging sector takes a step forward.
With time there has been an evolution in the pharma packaging sector along with a change in the type of products. The lifestyle products are gradually increasing in number and for such products visual eﬀect is a signiﬁcant consideration. These products are consumed over a long period of time, and thus, we have to ensure that proper quality is maintained. Also, such products have premium and hence people are ready to invest in them. Next, in the pharma packaging sector there is deﬁnitely a need for serialisation. Stability is an important factor that has to be considered. We can say that in order to bring India at par with the global pharma packaging sector, investments in technology is a must. Superior technology should be adopted so that visual appeal as well as the stability factor is considered.
Kishore Kar Vice President- Sales & Marketing India, South East Asia, PharmaSecure As far as pharma packaging is concerned, one issue that needs to be remembered is counterfeiting. Constant eﬀorts are being made in order to make the pharma packaging much more secure. Personally, after attending various global conferences one can easily see that people outside are aware of the progress that India is making. They consider India to be aggressive in this context. And it is interesting to observe that most of the decisions pertaining to the packaging sector is made keeping in mind the global picture. Developed countries have already adopted supreme technology for their pharma packaging sector. But this technology cannot be copied because it is an expensive aﬀair. Thus, there should be a speciﬁc form of technology dedicated for the emerging countries.
While the West relies on technology advanced ways for pharma packaging, India is yet to pick up pace on that front. Optimum utilisation of IT resources will place us on the global map and for this we require adequate investments.
Modern Pharmaceuticals I December 2011
Insight & Outlook: Biosimilars and Biobetters
Unique patenting issues A biosimilar aims to be a near-perfect facsimile of the biologic, analogous to a ‘generic’ in the small molecule space, but substantially more complicated structurally and from a manufacturing perspective. Conversely, a biobetter’s objective is to demonstrate differentiation from the original. Both biosimilars and biobetters can offer prospective growth to life sciences companies. We look at their patenting issues.
companies. This in turn results in the development of what are called biosimilars or follow-on biologics. Biosimilars are innovative copies of biopharmaceuticals; the features of these drugs being similar enough to expect the same safety and eﬃcacy as that of the original patented drug. However, distinct diﬀerence between biosimilars cannot be denied as they are made using a diﬀerent cell line and a diﬀerent manufacturing and puriﬁcation process. Moreover, each protein molecule has a unique multidimensional structure and mode of action, which can never be fully reproducible. In fact, biotechnological medicines, even with the same molecular weight and produced by the same type of cells or microorganisms, can possess diﬀerent pharmacokinetic and pharmacodynamic properties. Thus, unlike generic chemical drugs, biosimilars are not (bio)generics.
Introduction of biosimilars
biosimilar is a molecule that has a structure and properties similar to an innovator drug, providing the same therapeutic eﬀect. That is, biosimilars can be considered as generic versions of the originator drug, whereas a biobetter is a biologic which may include molecular or chemical modiﬁcations and would therefore constitute an improvement over the originator drug. The modiﬁcation may result in advantageous eﬀects such as reduced toxicity, a once-a-day dose, and so on. The biobetter is therefore a tweaked version of the originator drug, doing the same job, but in a better and smarter way. Biobetters potentiall y have less risk involved in their development because they build on already-validated targets. Depending on the process to create the biobetters, the platform may also be applicable to more than one product, thus saving substantial development dollars. And although biobetters will presumably require a full set of clinical trials to be
December 2011 I Modern Pharmaceuticals
approved by the regulatory agencies, this will also provide data exclusivity protection to companies for their biobetter compounds.
Biosimilars The marketing approval of the recombinant protein, HumulinTM in 1982 catalysed the use of genetically modiﬁed and transgenic organisms in industrial production processes and also the isolation of recombinant proteins from complex mixtures in commercially viable processes. In India, Shantha Biotechnics was the ﬁrst to launch India’s ‘ﬁrst domestically produced and marketed recombinant DNA product,’ Shanvac-B, a Hepatitis B vaccine. Shantha also developed an economical manufacturing process that lowered the cost of the vaccine. The vaccine is now manufactured and sold by a number of Indian companies. Expiry of the patent term for many biotechnological medicines results in free access of the patented techniques to pharmaceutical
Once the patent term expires, all patented drugs become available for development and manufacture by generic companies. This leads to large scale production and competition in the generic segment and also motivates the originator companies to expedite the development of new medicines to keep their market share intact. Such competition ensures that eﬀective, aﬀordable biosimilar drugs are introduced in the market soon after the patents expire. Since biosimilars are developed using an existing patented technology and have attributes substantially similar to their originator products, the development and approval process is expedited, which leads to their early introduction in the market.
Naming of biosimilars The numerous biosimilars which are manufactured by diﬀerent manufacturers may be ‘similar’ but are not ‘the same’. This mandates naming these products to indicate their stage of scientiﬁc advancement. Accordingly, all biosimilars should be allocated distinct international non-proprietary names to ensure their clear identiﬁcation and clarity of information among medical practitioners and scientiﬁc community.
Biosimilars and Biobetters Biosimilar guidelines Regulatory guidelines are recommended in various countries in order to obviate possible risks to patient safety due to administration of a biosimilar product as compared to its reference product. In Europe, the current regulatory guideline is provided in EU Directive 2004/27/EU according to which same standards are required for the approval of biosimilars as that of the originator product. In USA, in order to obtain the Food and Drug Administration (FDA) approval, it is mandatory to test the biosimilar against US reference products. The US Congress passed legislation creating a legal pathway for biosimilars under the Patient Protection and Aﬀordable Care Act in March 2010. In India, ‘Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/ Biological Products’, issued on 11 July 2008 makes it mandatory to provide regulatory and intellectual property status in other countries where the drug is marketed, approved and, if withdrawn, reasons thereof and patent information status in India & other countries.
Biobetters Biobetter (or biosuperior) refers to a biological product, similar to an already approved biological product, but superior in one or more product characteristics such as longer product half-life in the body, lower likelihood of aggregation, greater eﬃcacy, greater purity or fewer adverse eﬀects. Biobetters contain active ingredients similar to the parent drug but possess some molecular or chemical modiﬁcation that constitutes an improvement over the original drug. The advantage of manufacturing biobetters is the availability of information about R & D of the originator drugs, thus leading to lower cost for early stage development. As biobetters show better clinical eﬀects than the original drugs, these may also be patentable.
Patentability of biobetters Biobetter patent applications can be ﬁled
either for biological products (such as proteins, antibodies, nucleic acids and living microorganisms) or for process of isolation or modiﬁcation of these biological products (process patents) that, in turn, make them superior to the already present counterparts. Patent applications for new use of these biological products can also be ﬁled.
USA USPTO acknowledges that improvements made to an existing product of nature create a novel product of human endeavour, possessing features that were not present in the naturally occurring products. Accordingly, transgenic plants and animals, modiﬁed microorganisms and isolated and puriﬁed DNA sequences are considered novel and patentable.
As long as novelty and inventive step over pre-existing biological products or prior art can be demonstrated, both biobetter products and processes for preparation thereof are patentable.
It is possible to obtain grant for a wider breadth of claims in the US than in Europe. Additionally, since it is possible to encode a protein sequence if the DNA sequence is known, protein sequences can be claimed based on disclosure of DNA sequences. Contrarily, DNA sequences cannot be claimed based on known protein sequences (as more than one DNA sequence may be encoding for a single protein) and require more speciﬁc disclosure.
occurring in nature are not considered novel thus not patentable. Similarly, plants, animals and essential biological processes are not considered patentable. However, genetically modiﬁed microorganisms, human genetic material as well as biobetters are patentable in India. As long as novelty and inventive step over pre-existing biological products or prior art can be demonstrated, both biobetter products and processes for preparation thereof are patentable. Additionally, as biobetters are improvements of existing biological products, they should also demonstrate signiﬁcantly enhanced therapeutic eﬃcacy to be considered patentable.
The ruling... Biobetters can be patented in most of the jurisdictions provided that they are novel and show some technical improvement over their originators. However, in many cases it may not be possible to patent some biobetters, because the active ingredient is similar to an already known product. Biobetters are novel, independent inventions and therefore should not be confused with ever greening of patents or patent term extension. Biosimilars have been marketed in India under various brand names way before the possibility of ﬁling patent applications for the same was realised. However, one may infer from the granted patents for biobetters that process patents (and, to some extent, new use patents) dominate over product patents per se. Biosimilars lead to the formulation of biobetters, and in turn, biobetters result in the production of biosimilars, making the two terms complementary to each other. (email@example.com)
India In India, patent is granted for new product or process involving an inventive step and capable of industrial application. Mere discovery of a living thing or substances
Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra
Modern Pharmaceuticals I December 2011
Automation Trends: New barcoding regime
Advantages and disadvantages for
he global pharmaceutical packaging industry has witnessed a robust growth in the last few years mainly on the strong demand for pharmaceuticals which is poised to grow at a Compounded Annual Growth Rate (CAGR) of around 6.5 per cent during the period 2011 to 2013, according to a research
by RNCOS, a leading market research and information analysis company. This immense growth has also lead to the problem of drug counterfeiting, which possess a serious threat to the industry as well as consumers. The pharmaceutical industry has witnessed a steady rise in cases of fake, expired, adulterated, or unauthorised medical products reaching
Barcoding India’s pharmaceutical exports – will this help curb counterfeiting of drugs and improve the perception of the ‘Made in India’ tag? A look at the current trends provides hope to curb the fake drug problem. consumers resulting in huge losses for pharma companies through legal litigations from consumers and expensive product recalls. A report released by the Organization for Economic Co-operation and Development (OECD), mentions that 7.5 per cent of fake drugs supplied world over have some origins in India, followed by 7 per cent from Egypt and 6 per cent from China. The problem that regulators face is that illegal manufacturers of drugs are able to produce counterfeit items with such great accuracy that experts ﬁnd it hard to distinguish the fakes from the real drugs. To make matters worse it is also estimated that the global fakedrug industry is worth about $ 90 billion, causing deaths of almost 1 million people a year and contributing to a rise in drug resistance, according to a recent report published by Washington Times. This is serious news for India which is the world’s largest manufacturer of generic drugs and has become a busy centre for counterfeit and substandard medicines.
Improving the ‘Made in India’ tag? This raises the big question of how governments should regulate the ﬂow of legitimate drugs into their country. The
Modern Pharmaceuticals I December 2011
New barcoding regime Indian government estimated that 0.4 per cent of the country’s drugs are counterfeit and that substandard drugs account for about 8 per cent. But independent estimates range from 12 to 25 per cent with poor traceability of medicinal packages playing a key role in the growth of fake drugs across the country. Hence, ‘track and trace’ of individual pharmaceutical packages as well as an entire export pallet using high end bar coding mechanism is now being considered as an important tool in ﬁghting drug counterfeiting in India. To this eﬀect, the Directorate General of Foreign Trade of India had issued a notiﬁcation stipulating bar coding on exported medicines, vide Notiﬁcation No.21 (RE-2011)/2009-14 dated January 10, 2011, which was going to come into eﬀect from April 1, 2011 later extended to July 1, 2011. However, given the technical and ﬁnancial constraints of implementing this new mechanism and pressure from local drug manufactures in India, this stipulated date of July 1 was further postponed to October 1, 2011. According to this new regulation while primary-level packs will see incorporation of 2D bar codes (Data Matrix symbol) on medicines at strip, vial and bottle encoding of unique product identiﬁcation code, batch number, expiry date and serial number, similar details will be displayed on the secondary and tertiary (shipper or carton) using 1D or 2D barcodes. This vital information saved in the bar code can help regulators track medical consignment to the country of origin and have access to valuable information. Unlike barcodes, data matrix symbols can be applied directly onto the product or to the packaging box itself. It can also be read in any orientation and can contain alphanumeric information rather than just numbers, removing the need for a ‘look up table’ of product numbers. Implementation of this new international barcoding standard has also created an additional burden on small and medium pharmaceutical companies to an extent that the SME Pharma Industries Confederation (SPIC) has urged the Prime Minister’s Oﬃce (PMO) to order an investigation into the reasons behind the mandatory implementation of the barcoding mechanism for export-oriented
December 2011 I Modern Pharmaceuticals
pharmaceutical consignments. SPIC also argues that frequently foreign countries import medicines from India under generic names and barcodes have no meaning whatsoever in such cases as non-branded drugs are hardly ever counterfeited. This will only reduce their operating margins without serving the main purpose of stopping drug counterfeiting. However, industry experts believe that although implementing the GS1 bar coding standards would put additional pressure on the manufacturing cost and Indian companies could lose out on the cost competitive edge to countries like China but this measure is warranted for
Illegal manufacturers of drugs are able to produce counterfeit items with such great accuracy that experts find it hard to distinguish the fakes from the real drugs.
given the serious counterfeiting threat faced by the pharmaceutical sector especially in India. This is one of the reasons why pharmaceutical companies are today considering new leaner, more costeﬀective approach to track and trace. That is why many manufacturers are increasingly opting for networked smart camera vision systems over PC-based inspection systems. Compared to PC-based systems, smart camera vision systems are generally easier to conﬁgure, validate and maintain. Because they are solid state, smart camera vision systems intrinsically provide a more stable platform than Microsoft® Windows®-based alternatives, requiring less maintenance, and fewer service pack updates and patches to install. Being conﬁgurable, rather than programmable, smart camera vision systems can also make it easier for manufacturers to accommodate future changes in regulations and standards. Apart from installing less expensive hardware manufacturers mainly
in SME segment are also suggesting the option of a phase wise implementation of barcoding, which will drastically reduce the immediate ﬁnancial burden, which they are facing today. According to their suggestions the barcoding system should initially only apply to tertiary packaging (shipper or carton), instead of the current proposal for making it mandatory on all including primary, second and tertiary packaging. Through this measure of barcoding all pharma export consignments the government is not only trying to improve the reputation of the Indian pharmaceutical industry in the international market but it is also trying to curb illegal channels of trade such as the fake drugs found in Nigeria in 2009 labelled ‘Made in India’’ but were ﬁnally traced to China.
The next trend... As Indian pharmaceutical manufacturers move from their current traceability initiatives towards compliance with future ePedigree requirements, those that opt to add smart camera vision systems at the machine level will achieve the best balance of price and performance at each application level. And because smart camera vision systems can be combined with a variety of third party products, producers have the ﬂexibility to customise and scale their serialisation solutions to best suit their budgets and needs. With the deadline already rescheduled twice in the last one year we will have to wait and see how does the Indian regulator addresses the needs and problems of SME in the pharmaceutical industry while securing the life of people as well as the brand image - ‘Made in India’. It is going to be a tough decision to make, one which will witness rapid changes in India’s pharmaceutical sector. (firstname.lastname@example.org)
Didier Lacroix Senior Vice President - Worldwide Sales & Marketing, Cognex Inc
Energy Management: Pharma manufacturing units
best practices? Utilising energy efficiently and conserving it for appropriate usage is the need of the hour. We try to ascertain whether pharma manufacturing units are on the right track.
he term ‘energy’ and related phrases like ‘energy eﬃciency’ are gaining importance. Today, improving energy eﬃciency should be a strategic goal for any plant manager or manufacturing professional working in the drug industry. Not only can energy eﬃciency reduce overall manufacturing costs, it usually reduces environmental emissions,establishing a strong foundation for a corporate greenhousegas-management programme. Elaborating on the need of energy management practices
in the pharma industry, Dr H G Koshia, Commissioner, Food & Drugs Control Administration, Government of Gujarat, avers, “All pharma companies are required to follow Drug and Cosmetics Act and follow the Good Manufacturing Practices (GMP) standards. In fact, 7-10 years ago complying with these rules was not mandatory. However, with time, gradually companies are realising the requirement to conserve energy.”
HVAC: Important consideration For most pharmaceutical manufacturing plants, Heating, Ventilation and Air
Conditioning (HVAC) is typically the largest consumer of energy. HVAC systems consist of dampers, supply and exhaust fans, ﬁlters, humidiﬁers, dehumidiﬁers, heating and cooling coils, ducts, and various sensors. HVAC systems in manufacturing facilities are closely supervised by the Food and Drug Administration (FDA) and must aim to meet other global regulatory standards, so energy eﬃciency measures that aﬀect the work environment must conform to current GMP (cGMP). There are many energy eﬃcienct measures that can be applied to HVAC systems. Turning temperatures down in winter or up in summer during periods of non-use, such as weekends or non-production times, can lead to signiﬁcant savings in HVAC energy consumption. Similarly, reducing ventilation in clean rooms and laboratories during periods of non-use can also lead to energy savings. Adjustable speed drives can be installed on variable-volume air handlers as well as recirculation fans, in order to match the ﬂow and pressure requirements of air-handling systems precisely. In this way energy consumed by fans can be lowered considerably since they are not constantly running at full speed. Adjustable speed drives can also be used on pumps and water systems pumps in order to minimise power consumption based on system demand. Dr Koshia explains, “Pharma industry involves a lot of processes that requires electricity, such as ﬁltration, compression, ventilation and several other related aspects. Thus, it is required to see that energy is being conserved in every possible manner.” Heat recovery systems reduce the energy required to heat or cool facility intake air by harnessing the thermal energy of the facility’s exhaust air. Common heat recovery systems include heat recovery wheels, heat pipes and run-around loops. For areas requiring 100 per cent make-up air, studies have shown that heat recovery systems can reduce a facility’s heating/ cooling cost by about 3 per cent for each degree (Fahrenheit) that the intake air is raised/lowered. Additionally, in many instances, water cooling requirements can be met by cooling towers instead of water chillers. Water towers can cool water much more
Modern Pharmaceuticals I December 2011
Pharma manufacturing units eﬃciently than chillers and can thereby reduce the overall energy consumption of cleanroom HVAC systems. Boilers and steam distribution systems are major contributors to energy losses at many industrial facilities; they are therefore an area where substantial eﬃciency improvements are required.
Scientific and organised approach In order to see that most of the operations do not violate the energy concerns, it is extremely important to identify and locate the motor applications (like fans, pumps, etc) in the facility and document their conditions along with speciﬁcations. Additionally, it is required to compare the requirements against the actual use of the system in order to determine the energy consumption rate. This will facilitate in determining whether the motors are operating properly. Today, constant upgradation and updating is required. However, in order to approach a scientiﬁc way it is required to collect information on potential upgrades or updates to the motor systems, including implementation costs and potential annual savings. Thus, if one opts to update any equipment, it is important to monitor its performance over a deﬁnite time in order to determine actual costs savings. Further, there should be preventive measures considering electrical conditions, minimising voltage imbalance and including motor ventilation, alignment and lubrication. Also, there should be predictive measures to observe the ongoing temperature, vibration and other operating data in order to determine when to overhaul or replace a motor before it fails. Additionally, belt drive replacement is another way to save energy. Approximately 4 per cent of pumps have V-belt drives, many of which can be replaced with direct couplings to save energy. And more importantly replacing an old motor with a high-eﬃciency motor is often a better choice than rewinding a motor. Currently, there are no quality or eﬃciency standards for rewinding and motor eﬃciency typically decreases from 2 per cent to 25 per cent after rewinding.
December 2011 I Modern Pharmaceuticals
Pharma industry involves a lot of processes that requires electricity, such as ﬁltration, compression, ventilation and several other related aspects. Thus, it is required to see that energy is being conserved in every possible manner. Dr H G Koshia Commissioner, Food & Drugs Control Administration, Government of Gujarat
Maintenance: The key word Compressed air is mandatory for many pharma manufacturing applications, including equipment operation, vacuum cleaning, spray systems, ambient and instrument air in hazardous areas. And in pharma facilities, compressed air often comes in contact with products, such as in spray coating operations or in packaging, thus, it is often ﬁltered to meet strict contamination control standards. However, in spite of its importance, compressed air is one of the least energy-eﬃcient applications in any drug manufacturing plant. Eﬃciency of compressed air systems is only around 10 per cent; thus, the usage should be well monitored and especially should be seen against potential alternatives. Buying additional compressors should only be considered after a complete system evaluation. For improving eﬃciency maintenance is an essential aspect. Thus, the manufacturing facility should keep the compressor and inter-cooling surfaces clean. And blocked ﬁlters increase pressure drop, and more frequent ﬁlter changing can reduce annual energy consumption by 2 per cent. Next, the manufacturing unit of the pharma company needs to keep motors properly lubricated and cleaned. Compressor lubricant should be changed every two to 18 months and checked to make sure it is at the proper level. This will also reduce corrosion and degradation of the system. Water pumps, fans, drain taps should be checked to see that they are oﬀering their peak performances and regularly cleaned. However, some users leave automatic condensate traps partially open at all times to allow for constant draining. This should never be done, as
it wastes a substantial amount of energy. Instead of this, simple pressure-driven valves should be installed. Dr Koshia says, “Ensuring proper water distillation is a vital aspect. Distilled water is required for water for injection.” Therefore, it has been observed that inspecting and maintaining drains typically has a payback of less than two years. Thus, all applications requiring compressed air for excessive pressure, duration or volume, should be checked. They should be regulated either by production line sectioning or by pressure regulators on the equipment itself. Compressed air distribution systems should be checked when equipment has been reconﬁgured so that air is not ﬂowing to unused equipment or obsolete parts of the compressed air distribution system. It should be remembered that reducing the inlet air temperature reduces the energy used by the compressor. Thus, maintaining the temperature is an important consideration. Dr Koshia avers, “In order to prevent the microbial growth it is required to maintain the temperature at least at 80°C. The environment should be hot most of the times.” Therefore, in many plants, it is possible to reduce the inlet air temperature to the compressor by taking suction from outside the building. Additionally, gas engine-driven air compressors can replace electric compressors. Discussing the trend and requirement of energy management practices, Dr Koshia signs oﬀ saying, “With time regulatory guidelines are gradually becoming strict and there are various quality parameters that need to be followed. Be it a pharma SME or a large company, each of the unit needs to follow it.” (email@example.com)
Policies & Regulations: Differential pricing a tricky procedure where a company needs to consider a lot of factors before applying a diﬀerential pricing policy like the kind of investment required for discovery research and Industrial Property Rights (IPR) issues. Pharmaceutical industry has therefore been little cautious in adopting diﬀerential pricing. And this strategy has been restricted to a limited batch of drugs, mostly life-saving, and has not yet been expanded to encompass other drugs. Before delving into what needs to be done we need to understand what diﬀerential pricing is all about.
The mechanism of differential pricing and present Indian scenario
pros & cons Differential pricing is the method of selling drugs at different prices in different economies, and though immensely effective for the Indian economy this strategy has hardly been implemented in India. But the scenario has changed over the last few years where MNCs are starting to implement this strategy. Titash Roy Choudhury
ricing is an important driver of any economy and there are many factors that determine the price of any product.“The law of supply and demand applies to pricing of majority of goods,” says Dr Ajit Dangi, President &
CEO, Danssen Consulting. This is indeed true for most products but when it comes to pharmaceuticals it may not be strictly applied due to the social impact of pricing on patients. Healthcare is a crucial sector of any economy and a developing economy has more responsibility. Thus, determining the prices of pharmaceutical drugs is
Diﬀerential pricing is a strategy that in the context of pharmaceuticals relate to having diﬀerent prices for a product for diﬀerent economies depending on the purchasing power and geography of that economy. According to a study conducted for the UK Department for International Development (DFID), a report presented by Prashant Yadav last year said that diﬀerential pricing “could potentially be a very eﬀective strategy to improve access to essential medicines in low and middle-income countries where most patients pay for medicines out-of-pocket and therefore cannot aﬀord prices comparable to high income markets. In addition, a well implemented diﬀerential pricing system can lead to incremental sales for the pharmaceutical manufacturers.” Organisations like World Health Organization (WHO), World Bank, etc have found that diﬀerential pricing often helps in improving access to medicines in diﬀerent geographic and socioeconomic regions. “WHO has been routinely negotiating special pricing for less developed countries with pharmaceutical companies particularly for vaccines, contraceptives, antiretroviral products etc,” says Dr Dangi. According to him many companies also follow Advanced Purchase Mechanism where a special price is worked out provided, say next 3 to 5 years of take of a minimum agreed quantity is guaranteed for a particular institutional
Modern Pharmaceuticals I December 2011
Differential pricing purchase. “Diﬀerential pricing for institutional purchase through tendering process is quite common practice in India. However companies have to be careful of leakage of such supplies in retail markets. One way of preventing this is to have a diﬀerent packing for institutional supply,” says Dr Dangi. In the past, this strategy has generally not been adopted by major pharmaceutical ﬁrms in India, except for those treating certain diseases like HIV/ AIDS and malaria. Of late increased demand from emerging and large economies like India, China, Brazil, etc have resulted in many MNCs oﬀering diﬀerential pricing based on aﬀordability and purchasing power of a particular region, provided loss in proﬁtability can be made up by high sales volumes. Classic example is anti-diabetic product Januvia of MSD (Subsidiary of Merck & Co, USA), which is launched in India at 1/5th price prevailing in USA in spite of valid patent in India. This has resulted in MSD India getting a substantial market share in a short period of time. Due to large diabetic population in India, this diﬀerential pricing strategy is expected to generate high sales volumes. Over the last few years many MNCs in India are adopting this strategy, but pharmaceutical companies are still cautious about implementing this pricing strategy and there are various probable reasons for that.
Differential pricing can also be effectively used by having different pricing for branded product from its generic version, generic version being cheaper than the branded one. Dr Ajit Dangi President & CEO, Danssen Consulting having diﬀerent brand names for the same molecule in diﬀerent countries, although this often dilutes the power of global brands,” he adds. This reluctance is caused mainly by concerns that diﬀerential pricing could erode proﬁt margins in lucrative high and middle-income markets and high distribution channel markups in low-income countries could dilute much of the beneﬁts of diﬀerential pricing to poor end-patients.
Differential pricing allows pharmaceutical companies to signal that their pricing policies are socially responsible.
Why are pharma companies cautious? The pharma industry has been cautious about signiﬁcantly changing its pricing models, despite the theoretical appeal of diﬀerential pricing and its success in improving access to medicines in low- and middle-income countries. “Pharmaceutical companies are cautious about diﬀerential pricing and there are reasons behind it,” says Dr Dangi, like from the fear of parallel imports from low-priced countries to high-priced ones. “There has also been backlash from consumers in developed countries for subsidising less developed countries at the cost of high prices in their own countries. To prevent parallel imports, many MNCs follow diﬀerential pricing by
December 2011 I Modern Pharmaceuticals
Still be effective? According to the study, recent trends, however, are prompting the pharmaceutical industry to pay more attention to diﬀerential pricing. First, there is the economic and demographic growth in some low and middle-income markets, which has increased the potential market size of many low and middle income countries. Then there is greater recognition by the pharmaceutical manufacturers and their investors of the social responsibilities attached to their brand and their eﬀorts in helping access to medicines along with the growing competition from generic manufacturers in emerging markets.
Diﬀerential pricing allows pharmaceutical companies to signal that their pricing policies are socially responsible and consistent with their obligations to society and not just geared towards maximising proﬁts. In addition, diﬀerential pricing on select drugs opens opportunities to serve low and middle-income markets and creates economies of scope for pharma companies. “Diﬀerential pricing can also be eﬀectively used by having diﬀerent pricing for branded product from its generic version, generic version being cheaper than the branded one. Several MNCs have a subsidiary for generic drugs which markets the generic version of parent company’s branded drug at lower price. This ensures that brand equity of the parent company is not diluted,” informs Dr Dangi. However, we require more research on the ways of implementing diﬀerential pricing for all other drugs. Currently, this strategy is mainly used for life-saving drugs like HIV or vaccines, but more eﬀorts are required on how diﬀerential pricing can be expanded to include all essential medicines for low and middleincome countries and how fair, aﬀordable prices should be determined. Further research is also required to understand the impact of buy-side market structure on the social welfare impact and the operational feasibility of diﬀerential pricing. “In short, while diﬀerential pricing can be an eﬀective strategy to increase market access, one has to consider factors such as market dynamics, competition, impact on brand, IPR issues, aﬀordability as well as brand proﬁtability,” believes Dr Dangi. (firstname.lastname@example.org)
Strategy: Private label products in pharmacy retail
The trend changers Although it may seem that these PLPs will be less expensive or of low standards, that is not the case. We look at the Indian pharma space in this context.
as well. The major reason why supermarkets have a major share in sales from PLPs and not pharmacies is because, customer and consumer is same for FMCG categories but in pharmacy business, the customer and consumer are diﬀerent. The customer is the prescriber (doctor) and the consumer is the patient. So the decision of buying the products is dictated by the doctor for the consumer (patient). Though, with pharmaceuticals taking the generic route and future being of generics, the PLPs scene is bound to change drastically, and the PLPs could present a tremendous opportunity for pharmaceuticals as well.
Right strategy for Indian retailers
rivate Label Products (PLPs) or ‘in-house’ brands are the proprietary or ‘own’ brands that a retailer stocks and sells from his store. In 2009, PLPs accounted for 48 per cent of the total sales of the 30 EU retailers.
Statistical viewpoint If we see the country wise share of PLP’s; US: 15.1 per cent (Wal-Mart being an exception) Switzerland: 38 per cent Great Britain: 31 per cent Germany: 27 per cent Spain: 23 per cent France: 21 per cent Every year since 1999, super market retailers have ranked ‘stress private labels’ as the number 1 ‘likely action’ out of 26 priorities. The US experience has been no diﬀerent when it comes to PLPs. For example,
in Walgreens - A leading US drug store chain with over 3.6 million customer visits a days and with over 5,000 stores, prescription drugs made up approximately 63 per cent of the total sales in 2005, general merchandise was responsible for 25 per cent and OTC for 12 per cent of the sales. The share of PLPs category wise was 50 per cent in vitamins, 33 per cent in mineral supplements and 25 per cent in multivitamins. Walgreens gets 12 per cent of its total sales from PLPs compared to 7-8 per cent at CVS, Rite Aid and Brooks.
Bottom line and wallet advantage Gross margins for PLPs is more than 35 per cent (compared to branded products at around 20 per cent), and this is the most important reason why retailers try to sell more of PLPs. Also, PLPs mean signiﬁcant savings for the consumers
To start with, the Indian pharmacy retailers must not get into PLPs till they have signiﬁcant visibility and volumes; at least over 500 independent pharmacy stores. Also, while entering the PLP space, the stores could come up with products that fall into the FMHG category; like hand wash, ear buds, brushes, napkins, ayurvedic products, etc, and then gradually move onto the next level. PLPs should meet the following criteria: It should meet the customer needs Packaging should be as good as the ‘national’ brands Should compete with other products Have more value adds in the existing category Ultimately, should have a signiﬁcant price advantage It is better to start with a PLP in a category where there are only one or two products. This is where the product diﬀerentiation could be more prominent and the customer would have a choice.
Marketing & placement of PLPs The products should have their own visual identity and a catchy name that instantly connects to the customers needs. Placement of the PLPs should be next to branded products for the customer to compare the oﬀering with his requirements in the existing category. Training: A signiﬁcant amount of conversion from ‘national’ brands to
Modern Pharmaceuticals I December 2011
Private label products in pharmacy retail PLPs can happen due to sales persons intervention and explaining (ie, educated demand creation). So training of the store staﬀ is important on the product diﬀerentiators to drive conversions. Also, the marketing of PLPs requires a diﬀerent approach and needs more of in store marketing in the form of ﬂyers, audio visuals & sampling within the stores .
Which products? Before entering into the PLP space, the pharmacy retailers need to understand that there are three categories of product preferences from the consumer’s point of view. No preference (personal care and hygiene, ear buds, napkins, sanitizers, diapers, anti-bacterial soaps etc. Products that are more grocery driven and are a part of the monthly purchase basket). These products have an easier adoption amongst consumer for conversion Relative preference (OTC, multivitamins, health supplements, ayurvedic and herbal products, etc). With packaging and persuasion consumers can be converted to these PLP categories by the demonstration of the beneﬁts with respect to added ingredients, packing and price and thus helping them make an informed choice/decision Absolute preference (hair care, skin care, pescription products). Here the brand aﬃliations and aspirational value comes into play along with strict adherence to prescription from doctors. Diﬃcult to have a switch to PLPs The move to PLPs should be a logical progression from ‘no preference’ products to ‘relative preference’ products and ﬁnally to ‘absolute preference’ products. Though the cases of success in ‘absolute preference’ category are far & few. For the Indian healthcare consumer, pharmacies are the ﬁrst point of contact for common ailments like headache, stomachache, fever, acute ailments, etc. This is a great opportunity for people to enter into private label pharmaceutical products. Acute ailments are the ﬁrst category to move into and start with besides the other ‘no reference’ products.
So, the three critical reasons for success from marketing of PLPs are 3 Ps: Packaging Placement Persuasion
Key points for PLPs in India PLPs have to become ‘brands’ on their own, and so the parent chain needs to have a good visibility across the nation or the region. Despite being over two decades in organised pharmacy retail, India still does not have a national pharmacy brand. This is a big draw back. Most of the players are region speciﬁc – either South, North or East focused. So it is advised that till the pharmacy chain achieves 500 numbers across the nation, they should not get into the PLP space.
For the Indian healthcare consumer, pharmacies are the first point of contact.This is a great opportunity for people to enter into private label pharmaceutical products.
The retail traders association All India Organization of Chemists & Druggists (AIOCD) have started their ‘own label’ for about 80 pharmaceutical products and it is just about one year into business, so too early to comment. If AIOCD markets its products professionally and the quality is not compromised, it can make a dent into ‘national level private label products’ space as they will cater to over 1000’s of retail pharmacies, which are its members. Of course, the question is about the proﬁtability and the stiﬀ competition that it would face from regional players. Also that, these 1000’s of chemists are not owned by AIOCD and so it might not be able to uniformly market the PLPs. National level players have big expenses on supervision and marketing and that eats into the private label margins, as most of
the margins are with the retailer. Clearly , a national level pharmacy retail chain (with its owned stores) or a hospital chain has an advantage compared to other players. Few retail chains in India that started with Private label products started with a good number of PLPs in the very beginning, thereby, severely restricting its ability to focus on its niche and move ahead. The right thing would have been to start with 5-6 categories and then gradually move ahead and expand into more categories. Pharmacies in India have not been able to take the share of PLPs to more than 3 per cent ( single digit is also an optimistically high ﬁgure ) contribution to total sales. ‘Educated demand creation’ is lacking as the Indian pharmacy retailers think of ‘commoditising’ the healthcare products in the guise of PLPs. This strategy cannot work long term for a sustained PLP categories success. The quality, packaging and price of products will hold the key for the success of PLPs. For a major hospital chain, the pharma private labels gives a captive IPD (indoor patients) business and signiﬁcant margin savings. Taking that into consideration, we have a few hospital chains in our country who will signiﬁcantly beneﬁt from the PLPs business in pharmaceuticals PLPs can sell once due to promotion and persuasion but the ﬁnal test for success lies in the repeat purchase of the product and this is what has not been a focus area. Overall, while the future of PLPs is bright and assured, it is the right start at the right time with the right strategy that is the key to build a long term successful PLP business. (oﬃce@rajendragupta.in)
Rajendra Pratap Gupta International Healthcare Policy & Retail Expert
Modern Pharmaceuticals I December 2011
Product Inquiry Card
EASY STEPS TO GET PRODUCT INFO
Product Sourcing Just Got Simpler
1 See the index page in this issue. Every product carries a number. 2 Choose products of your choice from the list. 3 Write their serial numbers (as per the index page) of your chosen product/s one-by-one in the boxes. 4 Fill in your complete contact details. 5 Send it to us at the address printed overleaf.
-1 TIPIN THE BDOUXCETS
UR O L FIL TH PR OF YO D WI ER/S EN S ND MB NU OICE A CH
-2 TIP SE ENSUILRLEIN Name:___________________________________________________Designation:_________________________________________ Company:_______________________________________________________________________________________________
F A PLE T YOU ETAILS THA THE D RED ALL REQUI
POSTAGE WILL BE PAID BY ADDRESSEE
Business Reply Inland BR Permit No. 555 Bhavani Shankar Post Office, mumbai 400 028.
Special Project modern Pharmacuticals
InfomedIa 18 LImIted ‘A’ Wing, Ruby House, 1st floor, J K Sawant marg Dadar (W), mumbai 400 028 INDIA
NO POSTAGE STAmP NEcESSARY If POSTED IN INDIA
Tips & Tricks: Pharma manufacturing
Compliance Tips for GMP
ood Automated Manufacturing Practice (GAMP) guidelines from International Society for Pharmaceutical Engineering (ISPE) and US FDA’s 21 CFR part 11 regulations among others lay down and form some of the fundamentals for automation in the
Automation: Automation ips on production ﬂoor ricks through adoption of Manufacturing Execution System (MES) solutions has not only gained importance but is becoming increasingly vital. API players are focusing more on automation in process controls & material handling.
Counterfeiting: Data ips matrix code & RFID, have ricks become very important anti-counterfeiting measures. No doubt automation & IT solutions would help deliver quality products; human resources will remain the single most important asset.
Our industry is arguably the world’s most heavily regulated sector, therefore regulatory compliance has also become a major consideration when we talk about manufacturing. A few compliance tips on Good Manufacturing Practices (GMP).
pharma industry. The main reasons are the obvious reduction in cycle time inventories and quicker time to market. Apart from these, the other benefits are getting faster feedback about processes so that one can take corrective actions in time and the use of quicker non-destructive techniques for on-line measurements and correction.
Consistent supply of key starting materials (KSMs): It is important to fully characterise the KSM with detailed speciﬁcations including the complete impurity proﬁle and organic volatile impurity analysis. It is important to know the route of synthesis of KSMs.
Upgradation of process equipment: Listing and elimination of non-GMP equipment/parts from ﬁnal powder process areas and proper selection of gaskets and O rings vis-a-vis materials being used in a multipurpose plant is critical.
Elimination of human errors in operations: The key to elimination of human errors is to rapidly adopt process automation.
Robust process: To get ips consistent quality & yields ricks for APIs, the process has to be robust. To make the process stronger, we follow stage gate procedure in process development. It allows adequate time-gap and helps review processes with related responsibilities of various functions.
December 2011 I Modern Pharmaceuticals
Packaging consistency: Using the same packaging materials from R&Dto commercialisation helps manufacturers determine the possibility of interaction between the drug and its packaging early in the process.
Rajendra B Chunodkar Executive Vice President - Technical, Lupin Ltd
Strengthening of validation and investigation: It is not only the investigation team but production, engineering and process development should focus on the same. It is important to ﬁnd the correct cause and acting to correct it.
Rapid analytical techniques: These techniques are nondestructive and can be deployed on the production lines for continuous quality monitoring of output. This enables gathering large amount of data about the process, which was impossible to analyse using conventional sample testing.
HVAC & Water systems: Harmonisation on the speciﬁcations of HVAC and Water systems has to be achieved and ﬁnding shutdown time for the installation or modiﬁcations of systems despite consistent market demands is a must.
Projects New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry.
Argonne National Laboratory Project type New Facility Project news Argonne National Laboratory is building a new advanced protein crystallisation facility (APCF) in Illinois, US, which will help scientists across the world study the structure and function of different types of proteins. The project is being funded by the State of Illinois and is slated for completion in 2014. It is expected to generate 825 jobs during construction and another 550 indirect jobs upon opening. Project location US Project Cost $ 34.5 million Implementation stage Planning Contact details Argonee National Labotatory 9700 S. Cass Avenue Argonne, IL 60439, USA Tel: 001- 630 - 252-2000 ---------------------------------------------
Fortune Pharma Project type New facility Project news Fortune Pharma plans to set up a drug formulations unit with a capacity of 50 TPD and scheduled to be completion by end 2011. Project location Shendra in Aurangabad Maharashtra Project cost ` 80 million Implementation stage Construction Contact details Fortune Pharma (P) Ltd
Ist Floor, Tapadia Terraces, Adalat Road, Aurangabad - 431 001 Maharashtra, Tel: 0240-2338841, 2361935, Fax: 0240-2335273, E-mail: email@example.com ---------------------------------------------
of skilled human resources in the pharma sector. The proposal to set up additional was submitted to the Planning Commission by the Department of Pharmaceuticals (DoP) under the 12th Five Year Plan.
Merck & Co Project type New facility Project news Merck & Co will be setting up a R&D facility in Beijing. The 47,000 sq ft facility will serve as the companyâ€™s R&D headquarters in Asia and once the first phase of construction is completed in 2014 will employ around 600 staff. It will concentrate on drug discovery, translational research, clinical development, regulatory affairs and external scientific research programmes, according to Merck.
Project location Yet to be decided Project Cost ` 3,000 crore Implementation stage Planning
Project location Beijing, China Project Cost $ 1.5 billion Implementation stage Planning
Contact details Merck Corporate Headquarters One Merck Drive P O Box 100 Whitehouse Station, NJ 08889-0100, USA Tel: 001-908-423-1000 ---------------------------------------------
National Institute of Pharmaceutical Education and Research Project type New facility Project news The Department of Pharmaceuticals is to set up ten more National Institute of P harmaceutical Education and Research (NIPER) over the next five years to enhance availability
Contact details National Institute of Pharmaceutical Education and Research Sector 67, SAS Nagar - 160062, Punjab (INDIA). Tel: +91(172)-2292000, 2214682-87 Extn: 2174 E-mail: firstname.lastname@example.org --------------------------------------------Project type New facility Project news Massachusetts-based biotechnology company Vertex Pharmaceuticals (Vertex) is planning to move its headquarters from Cambridge to Fan Pier, on the Boston Waterfront. The move will consolidate the companyâ€™s headquarters and entire operations at Fan Pier. Project location Fan Pier Project cost $ 1.1 billion Implementation stage Planning Contact details Vertex Pharmaceuticals 11010 Torreyana Road San Diego, CA 92121-1103, USA Tel: 001-858- 404-6600 ---------------------------------------------
Modern Pharmaceuticals I December 2011
NATIONAL pre-grant and post-grant opposition, US patent systems and many other aspects; January 31-February 2, 2012, Holiday Inn, Mumbai INDORE Madhya Pradesh, Jan 6-9, 2012, Maharaja Shivajirao School Ground, Chiman baug
AURANGABAD Maharashtra, Feb 17-20, 2012, Garware Stadium
India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.
For details Infomedia 18 Ltd
Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: email@example.com
63rd Indian Pharmaceutical Congress Like the previous year, the theme of this year’s event is ‘Vision 2020: India - The Pharma Power House’. The event aims to showcase the progress made by the pharma industry in India. The unique feature of the event is the movement across the country and connecting with professionals across the country; December 16-18, 2011, Bangalore International Exhibition Centre, Bengaluru For details contact: Indian Pharmaceutical Association (IPA) Tel : +91 22 2667 1072 Fax : +91 22 2667 0744 Email : firstname.lastname@example.org Website: www.ipapharma.org
Pharma IPR 2012 This unique conference aims to unveil all the critical intellectual property related queries in the pharma and biopharma sectors and target at the on-the-spot solutions by leading global industry experts. This event will also offer opportunity to take advantage of panel debates, interactive sessions, practical case studies and facilitated Q&A sessions. This conference will bring the latest updates and relevant in-depth information on the most vital subjects including patentability, December 2011 I Modern Pharmaceuticals
For details contact: UBM India Pvt Ltd Tel: +91 22 4046 1466 Fax: +91 22 4046 1477 Email: email@example.com Website: www.pharmaipr-india.com
Lab Expo & Conferences It is a one of its kind event in the sector of lab equipment manufacturing, which will take place for two days and will include several informative sessions and workshops. These educative inclusions will be playing an important role in enriching the knowledge base of the professionals and entrepreneurs, who have been related to this profession for quite some time now. Lab Expo & Conferences - Chandigarh will be an important step forward for the makers of equipment used in professional and academic laboratories. Apart from being a platform where the industry representatives will display their products and services, this event will also make an attempt to be as much informative as possible for the first time visitors and participants; February 35, 2012, Parade Ground, Chandigarh For details contact: Paramount Exhibitors Tel:+ 91 172 2274801/2274802/2274803 Fax: + 91 172 2274803 Email:firstname.lastname@example.org Website: www.paramountexhibitors.com
ICBBB 2012 2 nd International Conference on Bioscience, Biochemistr y and Bioinformatics aims to bring together innovative academicians and industrial experts in the field of bioscience, biochemistry and bioinformatics on a common forum. The primary goal of the conference is to promote research and
developmental activities in bioscience, biochemistry and bioinformatics. Another goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in India and abroad; March 10-11, 2012, JP Hotel, Chennai, India For details contact: APCBEES Tel: +852-30697291 Fax: +86-21-56436721 Email: email@example.com Website: www.cbees.org
Pharmapack The event aims to provide an innovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc; February 2325, 2012, Bombay Exhibition Centre, Mumbai For details contact: Intel Trade Fairs & Expositions Pvt Ltd Tel: + 91 22 2862 8126 Fax: + 91 22 2281 9008 Email: firstname.lastname@example.org Website: www.intelexpo.com
3rd Annual Biosimilars With a 2-day strategic conference and post-conference workshop on clinical trials, Biosimilars India 2012 will bring together key stakeholders in the biopharmaceutical industry to learn about the latest industry developments and innovative commercialisation strategies that will propel your biosimilar strategies to the next level; March 27-29, Hyderabad For details contact UBM India Pvt Ltd Tel: +91 22 4046 1466 Fax: +91 022 4046 1477 Email email@example.com Website www.biosimilars-india.com
INTERNATIONAL 9th Annual Specialty Pharmaceuticals, Oral Therapies and Injectables This conference brings together leaders from the healthcare and pharmaceutical industry to share best practices and learn how to provide quality care while also maintaining a sustainable bottom line; January 18-19, 2012, Planet Hollywood Resort & Casino; Las Vegas, Nevada, USA For details contact: CBI 600 Unicorn Park Drive Woburn, MA 01801 Tel: +001- 339-298-2100 Fax: +001- 781-939-2490 Email: firstname.lastname@example.org
CBI’s 9th Annual Pharmaceutical Compliance Congress CBI’s Compliance Series addresses all aspects of a corporate compliance programme to bring together Chief Compliance Officers and their teams to share best practices and evolve compliance efforts across the industry. This series is headlined by this flagship meeting, CBI’s Annual Pharmaceutical Compliance Congress; January 24-25, 2012, The Ritz-Carlton, Washington, District of Columbia, USA. For details contact: CBI 600 Unicorn Park Drive Woburn, MA 01801 Tel: +001- 339-298-2100 Fax: +001- 781-939-2490 Email: email@example.com
Novel Immunotherapeutics Summit The Novel Immunotherapeutics Summit brings together experts from academia and industry to discuss cutting-edge research,
immuno-strategies and novel therapeutics against various diseases. Topics such as cytokines, inflammation, cancer immunotherapy, immunomonitoring, biomarkers, immunosuppression, allergy and asthma will be discussed at the summit. Attendees will also receive updates on government policy, recent regulations, important investments and partnering strategies; January 30-31, 2012, Paradise Point Resort and Spa, San Diego, California, USA For details contact: Global Technology Community Tel: 626-256-6405 Fax: 626-466-4433 Email: firstname.lastname@example.org Website: www.gtcbio.com
Biosignals 2012 The purpose of the international conference on bio-inspired systems and signal processing is to bring together researchers and practitioners f rom multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems. A diversity of signal types can be found in this area, including image, audio and other biological sources of information. The analysis and use of these signals is a multidisciplinary area including signal processing, pattern recognition and computational intelligence techniques, amongst others; February 1-4, 2012, Hotel Tivoli Victoria, Vilamoura Algarve, Portugal For details contact INSTICC Tel: +351 265 520 184 Fax: +351 265 520 186 Website: www.insticc.org
Nanotechnology, Biotechnology and Spectroscopy: Tools of success in the coming Era The event aims to be a worldwide gathering of pharma specialists. The specialists will also discuss the winning business strategies and examine the challenges and opportunities in the field. The conference will take place over 3 days, and will be divided into sections that allow focussing on the conference topics. The conference will consist of invited oral presentations and poster presentations selected from abstracts; March 1-3, 2012, Cataract Pyramids Resort, Cairo, Egypt For details contact: Nakaa Nanotechnology Network NNN Tel: 01521684185 Fax: 98-21-66465132 Email: nakaa.nanotechnology.network@ gmail.com Website: www.nakaanetwork.webs.com
BioNanoMed 2012 The event aims to be a platform for knowledge transfer in emerging nanotechnology for medical and biological applications. The purpose of this conference is to bring together researchers and practitioners from natural science, medical science and engineering subjects. Further, there will be discussion on nanostructured materials for regenerative medicine, multi disciplinary nano technologies; March 1-2, 2012, Danube University Krems, Krems, Austria For details contact Danube University Krems Department for Clinical Medicine and Biotechnology Tel: +43 0 2732 8932600 Fax: +43 0 2732 8934600 Email: email@example.com Website: www.donau-uni.ac.at
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
Modern Pharmaceuticals I December 2011
Event Preview: BioAsia 2012
Advocating lifesciences and providing a global networking platform The organisers and the cream of Hyderabad biotech industry came together to announce the ninth edition of BioAsia on November 21, 2011. They unveiled the focus areas for the annual global bio-business conference to be held in the city. A preview.
Dignitaries inaugurating BioAsia 2012 brochure
ith a vibrant theme of ‘Optimising Opportunities’ this edition of the event to be held from February 09 to 11, 2012 at Hyderabad International Convention Centre will focus on CROs, IPR, vaccines and investments. BioAsia 2012 promises to be the door to opportunities with the participation of a dynamic mix of high proﬁle industry thought leaders, policy makers and other key stakeholders of the industry. In addition, BioAsia has gone a step ahead to augment the global event through a basket of satellite event oﬀerings such as BioBazaar, BioPartnering, CEO conclave, tradeshow, policy discussions, conferences and more. In tune with the popular demand from the industry, BioAsia will be seen in a new avatar in 2012 as an advocacy and networking platform. In its ninth edition BioAsia 2012, will concentrate on panel discussions in place of technical discussions to enrich the levels of interactions between participants.
December 2011 I Modern Pharmaceuticals
“Already, representatives of top 16 MNCs in bio-pharma have conﬁrmed their participation. More business support elements like workshops, company presentations, luncheons and BioBazaar will be part of BioAsia 2012. A state-of-the-art partnering system which integrates professional and social networking platforms will also be part of this prestigious event,” announced Dr K V Raghavan, Vice President - Federation of Asian Biotech Associations (FABA) & Former Director, Indian Institute of Chemical Technology while releasing the brochure of the event.
Enhancing skill sets through workshops & masterclass Announcing the details of workshop titled ‘Labs of the future’, Satish Hiremath, Executive Director, Alexandria Equities Management (India) Pvt Ltd, said, “Research Laboratories are workplaces for scientiﬁc breakthroughs. This workshop will have sessions to cover multi and
interdisciplinary research facilities that have diverse needs. Through the power packed sessions one will learn some of the key architectural, engineering, operational, safety, techniques for the design of Research facilities.” BioAsia will also feature a masterclass on developing an eﬀective CIP and cleaning validation program for FDA/ EU compliance. “The workshop will be one-of-its-kind platform to learn, share & take away practical experiences in developing an optimised and eﬀective, CIP and cleaning validation program for FDA/EU compliance aimed at improving eﬃciency and quality of cleaning programs at bio and pharma manufacturing plants. fundamental cleaning engineering principles; cleaning mechanisms and agents; CIP system operations, components and functions; cleaning strategies for typical biopharmaceutical systems; validation considerations for design & implementation of CIP systems; cleaning related regulatory compliance points to consider, will be the focus areas for the workshop” said the coordinator for this workshop, Karan Manocha, Regional Manager (Asia Paciﬁc), Hyde Engineering and Consulting, Hyderabad The organisers also disclosed that a workshop on intellectual property management will be organised jointly with the Confederation of Indian Industry (CII). The tentative topics for discussion shall include perspectives on intellectual property and public health, opportunities and challenges in the ﬁeld of intellectual property, international regulation of IPRs and biotechnology: The future of TRIPS; role of intellectual property rights in innovation and development; intellectual property management policy in health research; technology transfer, merger & acquisition; critical IP issues for lifescience startups, etc. The organisers announced that the event looks promising to be most successful preeminent networking meetings in Asia, perhaps the globe. The organisers also thanked the Government of Andhra Pradesh, Government of India and its partners for their support so far in organising this event.
Event Report: API China & INTERPHEX China Autumn 2011
A beacon of win-win pharmerging synergies With the implementation of China’s new Pharmacopoeia and new GMP, its pharma sector seems set for a significant consolidation. On a positive note, amid such strategic shifts in China and a rather gloomy Western economy, the recently held Autumn edition of API China & INTERPHEX China assumed immense significance. A report… Manas R Bastia
he host city for API China & INTERPHEX China Autumn 2011 was Nanjing, the capital of Jiangsu province in China. It has served as the country’s capital during several historical periods and is recognised as one of the four great ancient capitals of China.
The vital stats Over the years, API China and INTERPHEX China have emerged as the leading bulk pharmaceuticals and allied industry events in China for the pharmaceutical manufacturing sector. These include key segments such as pharmaceutical ingredients, intermediates, excipients, ﬁne chemicals, contract manufacturing, processing machinery,
packaging materials and machinery. Moreover, it strives to provide an integrated platform for procurement services and information sharing for industry players, through continuous eﬀort, innovation and improvement. Organised by Reed Sinopharm Exhibitions (RSE), China’s largest exhibition organiser in the healthcare and pharmaceutical industry, the 67th edition of API China and INTERPHEX China commenced with a traditional colourful ceremony on November 9, 2011. The event was actively supported by the China Pharmaceutical Industry Association (CPIA), China Pharmaceutical Packaging Association, Indian Drug Manufacturers’ Association (IDMA), Sinopharm Group, Reed Exhibitions, and China National Pharmaceutical Industry Corporation, among others.
During the three show days, more than 1,400 exhibiting companies and 30,000 visitors from 50 countries and regions attended this biannual event. One of the key highlights of this edition was the launch of ‘Pharmaceutical Excipients Day’, in collaboration with Phexcom. Based on pharmaceutical excipients area, the objective was to enhance understanding and co-operation between drug manufactures and excipients suppliers. Besides, the 5th API China Forum on Pharmaceutical Excipients was held during the show. On the next phase of growth, Daniel Chan, Director - International Business, RSE, said, “We are planning a Global Buyer Port (GBP) by extending the Indian Buyer Port (IBP) concept to oﬀer the best value-for-money Chinese products to global players. We also want to make sure that the quality of products
Modern Pharmaceuticals I December 2011
API China & INTERPHEX China Autumn 2011 to be showcased at API China is of world-class to meet the evolving market needs.”
competition between India and China in APIs, the world will get beneﬁtted by the most economical generics.”
More than just APIs… With the anvil of new GMP norms and higher manufacturing standards, the rules of drug electronic supervision have come into eﬀect from March 2011 in China. This in turn has triggered the need for suppliers of system integration equipment, coding equipment, printing equipment, etc. Sensing this development, INTERPHEX China had a dedicated Packaging Machinery Area besides Clean Room Equipment Area and Pharmaceutical Electronic Supervision Area. The Pharmaceutical Packaging Material section, not to be left behind, showcased following six special areas: Plastic Packaging Materials Area, Caps & Butyl Rubber Stoppers Area, Pharmaceutical Glass Area, Printing & Packaging Area, Aluminium Packaging Area, and Capsule Area. This event reﬂected growing interest of the overseas producers towards the Chinese market. According to Ryusaku Otsuka from Kyodo Printing Co Ltd, a Japan-based MNC that specialises in Push Through Packaging (PTP) for pharmaceutical tablets, powder etc, “We are here to expand our business to other countries. We intend to begin by exporting our products to China followed by building a plant here for production, if successful in the ﬁrst phase.” Another value-add of this show was the presence of allied services providers. In the words of Hong Leong from PSC Asia, a Singapore-based provider of validation, compliance, regulatory aﬀairs, and engineering support services to pharmaceutical and biotechnology industries, “We want to expand our customer base in China, especially in the API category who want to access markets in the US and Europe. Thanks to healthy
December 2011 I Modern Pharmaceuticals
Successful saga of SIPP The Sino-India Partnership Program (SIPP) was launched at API China Xi’an (Spring 2009), with an aim to bring a closer relationship between the pharmaceutical industries of China and India, as well as to present a new business experience for participants from both countries. With 30 companies presenting their buying needs in its sixth edition, SIPP Autumn 2011 in Nanjing provided a platform for learning, sharing, developing and securing business. The 2nd Sino-India Forum, supported by CPIA and IDMA continued to deliver an educativeexperienceonpharmaceuticalindustry overview, regulatory requirements to enter China market, the scopes and opportunities oﬀered by the Chinese pharmaceutical industry, Sino-India pharma synergies, etc. The theme of this edition was ‘Harmonious collaboration amidst competitive environment’. Speaking on this occasion, K Nagaraj Naidu, Counsellor (Trade & Commerce), Embassy of India, Beijing, observed, “Indian companies with good generic drugs portfolio and price competitiveness stand to gain in China. The key is to tie-up with right partners in China who can provide speedy access to the Chinese market. The areas of collaboration may include biotechnology, new bio-similars, vaccine development, clinical testing and contract manufacturing, among others. Platforms such as this will provide a strong boost to pharma companies of both countries.” In fact, it was felt that SIPP should broaden beyond annual trade show and enhance transfer of technology, closer alliance between Indian and Chinese pharmaceutical industries.
It should also address challenges such as giving Indian pharmaceutical companies more access to the Chinese market and narrowing the trade deﬁcit in bilateral trade. Sharing his perspective N R Munjal, President, IDMA, said, “It is time to work jointly to reduce the trade deﬁcit growing between Indian and Chinese pharmaceutical markets. With China’s expertise in basic chemicals, intermediates and some APIs along with India’s strength in ﬁnished dosage form, the time is ripe for India-China collaboration to provide one global solution.” Dhiren Shah, Managing Director, Eastern Chemicals (Mumbai) Pvt Ltd, one of the leading names in the indenting market of India, who has been regularly attending API China since 2005, had a well-informed viewpoint. In his words, “Performance of API China is superior as compared to other shows due to better distribution of exhibitors in terms of manufacturers and traders as well as added advantages of having small-scale manufacturers and unique concepts such as IBP and SIPP. However, language is still a hurdle in realising the full potential of the Indo-Chinese pharmaceutical trade.”
Time for pharmerging synergies As the Chinese pharma landscape continues to shift swiftly to meet SFDA GMP norms as well as given India’s domestic need and position of strength in the fast emerging generics markets, there would be unprecedented opportunities for sourcing and selling between these fast emerging economies. Hopefully, events such as this would usher in new strategic synergies of India-China collaboration in the pharmaceutical space for their own good as well as the larger global cause. (firstname.lastname@example.org)
Event Report: PMEC & CPhI India 2011
An event full of momentum The main objective of this event is to get professionals from India and across the world on a common platform to interact, engage and develop new business opportunities. Living upto the expectations and reputation, CPhI India and P-MEC, the three-day event held during November 30–December 2, 2011, saw a huge footfall in terms of exhibitors and visitors.
PhI India and P-MEC India is the largest and most comprehensive pharma industry event in South Asia and have gained a reputation as the ‘must attend’ event in this industry. Additionally, ICSE India has quickly gained a positive reputation in the market by oﬀering direct access to the outsourcing and contract services sector, which is one of the fastest growing segments within the Indian pharma industry. The event this year was inaugurated at the Bombay Exhibition Centre, Goregaon, Mumbai, by Martin O’ Malley, Governor of Maryland; N R Munjal, Chairman, Pharmexcil; and Sanjeev Khaira, MD, UBM India.
Highlights After the inaugural ceremony, the exhibition was open to all. The ﬁrst day of the exhibition saw an overwhelming turn out, from both domestic and international visitors. There were approximately 825 exhibitors from 21 countries. Like every year, CPhI India and its co-located events oﬀered a great platform to the attendees to network with key decision makers in the global and Indian pharmaceutical industry. Lupin Ltd, Piramal Healthcare, SGS Life Science, Aurobindo Pharma and the likes participated in the exhibition. The three day exhibition came to an end on 2nd December 2011. Like every year this year too the event received huge response from the company personnel. The exhibition at the event served as a great platform for the
industry meet and adequate knowledge transfer. Elaborating on the product showcasing and the exchange of views in the event, Jutta Vogel, Sales Coordinator, Neoceram said, “It is indeed an exciting event as there is a vast display of product and technology that are in use in the pharma world today. Such types of event give a chance for true exposure.” Further, commenting on the exhibition and the opportunities in the event, R B Joshi, Zonal Head - Marketing, Karnavati Engineering Ltd, said, “This meet is extremely helpful for the pharma industry and particularly pharma machinery segment. We can display our range of exhibits and other companies can share their technologies and equipment. Therefore, such type of information exchange enhances the knowledge bank of all the companies.” Seconding the above
Modern Pharmaceuticals I December 2011
PMEC & CPhI India 2011
thought, Pranay Patel, Director, National Pharma Machinery, said, “This type of exhibition helps us in knowing about the top technology in the market. Additionally, we are also informed about the demand and what our clients want from us. Thus, this type of event ensures that we are on the right track.” Also discussing the industry requirements and how this event caters to the need of the industry, Santosh Kulkarni, Area Manager, Customer Relations, sortimat Technology Pvt Ltd, said “Everything is constantly changing. Similarly, the demands of pharma companies are also changing and we have to meet these demands. Therefore, we have to be up to date and upgraded regarding the technology along with the demands. This will help us in fulﬁlling the requirements of the industry.”
Success measure Commenting on the occasion, Khaira said, “CPhI India 2011 received an overwhelming response. We hope the exhibition strengthens business relations between the Indian and global pharma companies. With the Indian market growing impressively, connecting with new companies, building new relations to bring in greater technology is extremely important and such platforms provide appropriate opportunities for the same.” This year the event witnessed a phenomenal increase in the number of visitors vis-à-vis
previous years. Growing visitor and exhibitor participation from overseas strengthens the fact that the Indian pharma industry is receiving global attention and recognition. The pharma industry in India has shown tremendous growth in the past few years, at a rate of 20 per cent per annum, beneﬁtting from the increasing domestic and global demand for high quality generic drugs.
Growing bigger and better CPhI/P-MEC focusses on the entire industry, attracting the key players and decision makers from across the pharma world who are keen to learn about the current industry trends, and expand their networks – as well as ﬁnd new and competitively priced sources for the product and services they need. Discussing the event, Khaira added, “India’s expertise in pharma manufacturing and associated services has helped the industry achieve the coveted position of being the fourth largest drug producer in world, with a proven reputation for quality and cost-eﬀectiveness” Technologically strong and totally self-reliant, the pharma industry in India has low costs of production, low R&D costs, innovative scientiﬁc manpower with research capabilities. This has helped to place India on the pharma map of the world and take on the international markets. Over the past 5 years, CPhI/PMEC India 2011 has established itself as the most signiﬁcant networking and procurement event for the Indian and overseas pharma companies, and continues to do the same.
December 2011 I Modern Pharmaceuticals
Book Review Principles and Techniques of Biochemistry and Molecular Biology Editors: K Wilson and J Walker Price: ` 495 In this edition of a highly popular text, students and readers are introduced to all the basic experimental techniques routinely used in practical biochemistry today. Primary attention is given to techniques students will encounter in their practical classes, with the principles and theories behind them explained in detail to aid understanding. This new edition of the book integrates the theoretical principles and experimental techniques common to all the courses in the bio- and medical sciences. Three of the 18 chapters have new authors and have been rewritten completely. Two new chapters have been added. One on clinical biochemistry discusses the principles underlying the diagnosis and management of common biochemical disorders. As a further aid to students, essential calculations and worked answers appear at the end of each chapter. There is hardly any contemporary book on modern biochemical techniques that can be complete without chapters on molecular biology, recombinant DNA technology, genetic analysis and biomolecular interactions, and these topics have been extensively covered in this new edition. The book is therefore essential reading for all bioscience undergraduate students and preclinical medical students for whom practical biochemistry, molecular biology and immunology form part of the syllabus.
Lehninger Principles of Biochemistry Editors: Dave Nelson and Mike Cox Price: ` 1615 The book has variety of current subjects that showcase the state-of-the-art described with unique illustrations. The students or the readers must have some basic chemical knowledge to understand the text, and in some places the authors refer back to subjects that are only discussed in detail later on in the book. In any case, the work overall is readily understandable, and it is elaborately detailed for use both for learning as well as for the reference purpose. Illustrations are of high quality and they make the content reader friendly and simple. The contents of the book are in line with the latest research. Also, the book is recommended for those who are already working in medicinal chemistry or related areas, since in addition to the elementary background material contained, current research topics such as signal transduction are addressed in exacting detail in the book. The book will be an interesting read to anyone who plans to work in the life sciences industry. It is a good aid for those students who intend to specialise in molecular biology. In this book one finds all the topics in biochemistry, each with detailed and well-illustrated explanations.
Jayeeta Saha M.Sc in Botany, Specialisation in Biochemistry, Physiology and Molecular Biology, University of Calcutta
Modern Pharmaceuticals I December 2011
Products Sticker labelling machines Denmark Machine Tools oďŹ€ers automatic vertical sticker labelling machines that are most user-friendly. These machines are suitable for labelling on round vials, bottles and other round objects. The machines are capable of labelling up to 150 containers per minutes depending on product size and label size. These machines are equipped with roller spacing device and in-built automated label length detection systems that eliminate the need for manual feeding and storing of label length data in memory and retrieving the same for change of the label size and restarting the machine. Features include: no change parts required, virtually maintenance-free 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. Denmark Machine Tools - Ahmedabad - Gujarat Tel: 079-2220 1140, Fax: 079-2220 1140, Mob: 09727716599 Email: email@example.com Website: www.denmarkmachine.com
December 2011 I Modern Pharmaceuticals
Products Capsule filling machines Manual capsule ﬁlling machines oﬀered by Karishma Pharma are designed and manufactured to handle all sizes of capsules ranging from 00 to 5. These machines have an output of 5000 to 6000 capsules per hour, which can be increased with the help of automatic loading machines. The dimensions of the manual capsule ﬁlling machines are 395 mm x 240 mm x 500 mm. These machines weigh 45 kgs. Though all the operations are manual, the machines call for precision machined components and assembled with highly skilled personnel. The manual capsule ﬁlling machines are widely used in research laboratories, academic institution and medium-to-small scale manufacturing industries. Karishma Pharma Machines - Mumbai - Maharashtra Tel: 022-2380 5979, Fax: 022-2381 1849, Mob: 09821069064 Email: firstname.lastname@example.org, Website: www.karishmapharma.com
Gravity feed metal detectors Target Innovations oﬀers gravity metal detectors that are designed to detect metal contamination in dry, powdery or granular free-ﬂowing products that can be gravity fed through a pipe. These systems feature high sensitivity, high throughput and are compact in size. Both the reject chute and frame are of stainless steel. Inspection chute going through the metal detector is made from polypropylene, nylon, Teﬂon or plastic, depending on the application. The metal detectors are designed to minimise system space, and product waste while insuring maximum sensitivity to all metals. Metal-free products are passed straight through the mechanism and divert the ferrous, non-ferrous and stainless steel contamination from the main ﬂow. The systems are available in aluminum or stainless steel casing. Diverter valve reject system is typically used to divert contaminated product into a reject tank. Features include: high sensitivity, automatic rejection of contaminated product, compact design, straight through ﬂow design, does not have crevices or traps, fast acting electronics, comprehensive self diagnostic system, automatic noise compensation and reject conﬁrmation. The gravity metal detectors are used in pharmaceuticals, bulk drugs, chemical & dyes, food ingredients, etc. Target Innovation - Navi Mumbai - Maharashtra Tel: 022-2779 0077, Fax: 022-2779 1313, Mob: 09823309636 Email: email@example.com Website: www.targetinnovations.com
Vacuum pool systems Joyam Engineers & Consultants has developed an innovative vacuum pool by integrating two vacuum pumps and a reservoir tank. Energy saver vacuum pool systems are ideal for ﬂuctuating
processes. These systems greatly improve the performance of such processes. The demand for air/vapour evacuation in certain kind of process applications ﬂuctuates as the process parameters vary with time. These energy saver vacuum pool systems keep vacuum virtually constant. Since the systems are designed for best possible capacity control, these are big time energy savers. The systems also feature recirculation of sealing liquid with intercooling. This feature signiﬁcantly cuts down on the cost of sealing liquid and reduces the load on eﬄuent treatment. Salient features include: meet the ﬂuctuating process demand keeping the vacuum constant; automatic capacity control saves considerably on electrical energy; and recirculation of sealing liquid with inter cooling saves the cost. Joyam Engineers & Consultants - Ahmedabad - Gujarat Tel: 079-2656 9533, Fax: 079-2656 2777, Mob: 09879099100 Email: firstname.lastname@example.org, Website: www.joyamvactech.com
Tray dryers Aero Therm Systems oﬀers tray dryers that have capacity of 12 to 200 trays of 32” x 16” x 1.25” size. Temperature ranges are available up to 550°C. Fan impellers are of axial ﬂow design to give better uniformity and quick drying. Digital temperature indicators and controllers give accurate temperature control. Control action can be on/ oﬀ or PID as per control accuracy required. Construction of the dryers can be made of MS/aluminium/SS-316/304 of FRP lined as per requirement. Flameproof and spark versions are also available. Heating can be electrical, thermic ﬂuid or steam radiator/oil ﬁred hot air generators. Aero Therm Systems Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2589 0158, Fax: 079-2583 4987 Email: email@example.com Website: www.aerothermsystem.com
Modern Pharmaceuticals I December 2011
Products Screening machines Allgaier Werke oﬀers tumbler and vibration screening machines according to GMP and FDA-regulations for applications in pharmacy, food and ﬁne chemicals. These specialised machines are used for treatment of valuable powders, pellets and granules. The hygienic design includes solutions for WIP-cleaning devices and ATEX certiﬁcation. The tumbler screening machines are high-performance screening machines for fractionating, protective screening and dedusting. Threedimensional tumbling movement creates exceptional ﬁne cuts for the bulk solids. The modular design allows the production of additional fractions through additional screening desks in one machine. For simple applications vibration screening machines, type VTS or Vibrall, are economic alternatives (claims the company). Allgaier Werke GmbH - Uhingen - Germany Tel: +49-7161-301353, Fax: +49-7161-34268 Email: firstname.lastname@example.org, Website: www.allgaier.de
December 2011 I Modern Pharmaceuticals
Products Disposable bioreactors
Capsule filling machines
Lablinks Biotech oﬀers disposable bioreactors that are as opposed to conventional bioreactors, single use systems made of medical grade plastics which are presterilised and ready for use, therefore not needing cumbersome SIP and CIP. Agitated by means of an external gyrational motion, which uses gravity naturally to make the contents ﬂow in a uniform circumferential direction in a specially shaped round bag, these disposable bioreactor systems have deﬁnite advantages over the conventional and existing disposable bioreactors that are manufactured in the other countries. Produced in Class 10000 cleanrooms with imported medical grade PVC ﬁlm, the disposable bioreactor systems are very versatile and can be used to manufacture high end vaccines to low end bio-fertilizers.
Anchor Mark oﬀers automatic capsule ﬁlling machines also known as encapsulation equipment. Salient features of these machines include: compact, sturdy, covered with stainless steel panels, hood covered with acrylic guard. The ﬁll weight adjustment takes place within seconds. These machines are provided with tamping mechanism for powder ﬁlling, which enables capsules to be ﬁlled with a weight variation with ±2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. Faulty capsules and ﬁlled capsule ejection stations come with individual air controls. These are simple-to-operate and easy-to-maintain and have special-purpose gauges for quick and easy changeover. Also oﬀered are powder processing/granulation and coating equipment, whose design and ﬁnish conforms to cGMP standards. These come with special air-purged shaft seals, which keep the powder away from the mechanical drives and prevent product contamination.
Lablinks Biotech Pvt Ltd - Bengaluru - Karnataka Tel: 080-3244 0830, Fax: 080-2790 4790, Mob: 093437 48099 Email: email@example.com, Website: www.lablinksbiotech.com
Anchor Mark Pvt Ltd - Mumbai - Maharashtra Tel: 022-2868 2001, Fax: 022-2868 2250 Email: firstname.lastname@example.org
Atlanto Enterprises oﬀers silicon moulded sifter sieves, ﬂuid bed dryer (FBD) sieves and FBE dryer sieves. The silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. Silicon, which is of food-grade quality, transparent in appearance and non-toxic, is moulded on the stainless steel ring. These are available in rivetted and special non-rivetted design. The mesh sizes varies from 4 mesh to 500 mesh with ASTM & BSS Standards. Fluid bed dryer (FBD) sieves are available in various sizes, from 30 kg to 200 kg. The FBE dryer sieves are also available in various sizes ranging from 125 ltrs to 800 ltrs. These sieves used are in Dutch woven screens and hollander screens. The most common sieves used are 30 x 150 mesh. All these sieves are available with complete set of certiﬁcates (claims the company).
Allegro Pharmachem Equipment oﬀers coating pans that are totally enclosed with stainless steel cladding and are available with standard gearbox, motor and hot-air blowing arrangements. These coating pans are provided with interlocked electrical circuit so that the heaters can be operated only after the blowers are switched ON to avoid burning of the heaters. The coating pans are manufactured from the SS-304 AISI 2B prime material quality with adequate mouth opening and depth. Coating machines are also provided with the control panel that are available with indicating lamps, coating pan main ON-OFF switch, blower ON-OFF switch, thermostat, heater switch, etc. The entire panel can be mounted on the stand. The machines are designed as per the GMP standards, with all arrangements inside the enclosure, except the electric control panel and SS pan.
Atlanto Enterprises - Mumbai - Maharashtra Tel: 022-2309 6098, Fax: 022-2307 3537 Email: email@example.com
Allegro Pharmachem Equipment - Thane - Maharashtra Tel: 022-4014 6872, Fax: 022-4014 6874 Email: firstname.lastname@example.org
Modern Pharmaceuticals I December 2011
Products Vacuum pumps Cole-Parmer oﬀers a complete line of vacuum pumps that includes oilfree as well as rotary vane pumps for laboratory, environmental sampling, process and OEM use. These pumps are suitable for most of the applications related to research work, which require ultimate vacuum range between 100 mbar to 0.001 mbar. Two-stage rotary vane vacuum pumps are newly designed and most suitable for most of the laboratory applications. These pumps have very minimum wear & tear parts and hence they are meant for longer life without service hassles. The high-contact metal parts are plasma-treated to yield the maximum corrosion resistance. To increase the service intervals the pump features an anti-suckback valve to inhibit corrosive vapours from entering the pump. These pumps with higher displacement rates are ideal for applications wherein evacuation is required in a faster rate. Features include: compact design: half the size of a typical rotary vane pump, easy to carry; energy-eﬃcient motor: reduces cost of ownership; easy operation & maintenance; very low noise level; and equipped with gas ballast for speciﬁc applications. Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222, Fax: 022-6716 2211 Email: email@example.com Website: www.coleparmer.in
Laboratory products Remi Elektrotechnik recently launched its new Plus range of laboratory equipment. This range of laboratory products for upgraded needs of today’s laboratory setups are aesthetically designed models equipped with high-performance, leading technology, user ease and safety will help customers to have better control over operational processes in the laboratory, at the same time reduce chances of errors. The Plus range includes magnetic stirrers, laboratory stirrers, cyclomixers, compact refrigerated centrifuges, refrigerated centrifuges, orbital shaking incubators, cabinets, humidity & stability chambers and seed germinators. Remi Elektrotechnik Ltd - Mumbai - Maharashtra Tel: 022-4058 9888, Fax: 022-4058 9890, Mob: 09820627422 Email: firstname.lastname@example.org, Website: www.remilabworld.com
December 2011 I Modern Pharmaceuticals
Products Rotary vacuum dryers
Vacuum tray dryers
Double-cone rotary vacuum dryers from Alpha Process Engineers oﬀer clean, simple and eﬀective method of drying wet cake, powder and even slurry. Labour and energy costs are minimal and product losses during handling are also negligible. Additionally valuable organic solvents can be conveniently condensed and recovered. The drying in a rotary vacuum dryer is a batch operation under vacuum. It is possible to dry heat sensitive materials at well below boiling points of water and solvents. Drying time depends on material being dried, amount of solvent or water to be removed, desired ﬁnal moisture content, permissible jacket temperature etc. These dryers are available in capacities ranging from 100 liters to 1,000 liters. The dryers are equipped with diﬀerent designs of agitators depending on the material to be dried. Leakproof reputed rotary joints/seals are used. Materials of construction are stainless steel and carbon steel.
CPK Engineers oﬀers high-grade vacuum tray dryers in various shapes and sizes. These tray dryers are aptly designed for drying thermal sensitive materials, which can be easily resolved, degraded or polymerised under high temperature. Sterilisation of the materials can be conducted before drying process as no other materials are allowed to enter once the dryer is started. Besides, it also assists in elimination of conﬁgurational damage of drying materials. The vacuum tray dryers are oﬀered in various sizes, such as 6-tray, 12-tray, 24-tray, 48-tray, 72-tray and 96-tray. Tray sizes are available in 800 mm x 400 mm and 32 ht. Salient features include: all SS-316L/316/304 CGMP or MS externals with SS internals (vapour & product contact parts); condenser & condensate receiver ﬁtted on the dryer body or standalone for emote installation; hollow pad-type heating shelves, which are easily removeable for maintenance; fully-welded skirt or vacuum dryer body for ﬂush-mounting through the wall; explosion vent or rupture disc or vacuum chamber; validation ports & nitrogen purging valve, vacuum beak valves available on the vacuum chamber; and solenoid controlled pneumatic operated valve located at hot water inlet.
Alpha Process Engineers - Chennai - Tamil Nadu Tel: 044-2811 1351, Fax: 044-2811 2371 Email: email@example.com, Website: www.alphaprocessengineers.com
Water-ring vacuum pumps & compressors Vacunair Engineering Co oﬀers water-ring vacuum pumps and compressors that have non-pulsating vacuum and pressure. Energy saving pumps design by operating at low periphery speed and oﬀer vacuum pumps for power of 60 m³/hr to 65 m³/hr per kW. These pumps are available in wide selection for any requirement range from 20 m³/hr to 7000 m³/hr, vacuum up to 700 mm Hg and m³/hr and vacuum up to 25 mm Hg abs. Standard pumps are available with stuﬃng box type gland seal arrangement and can also oﬀer with mechanical seal. Impellers are duly dynamically balanced as per ISO:1940-1973 (E) class G 6.3. Vacuum pumps are available in CIFG-260, gun metal, phosphor bronze, aluminium bronze, SS304, SS-316 and other alloy steel. The water-ring vacuum pumps and compressors are widely used in industries like chemical, pharmaceutical, fertilizer, paper, sugar, coalmines, power, steel, reﬁnery, dairy, plastic, food processing, textile, etc. Vacunair Engineering Co Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2291 0771, Fax: 079-2291 0770, Mob: 09904003010 Email: firstname.lastname@example.org, Website: www.vacunair.com
CPK Engineers Pvt Ltd - Hyderabad - Andhra Pradesh Tel: 040-2373 5424, Fax: 040-2373 3298 Email: email@example.com, Website: www.cpkengineers.com
Oscillating granulators Jicon Machines oﬀers oscillating granulators for uniform granulation of dry and wet lumps of powders. The main structure of these machines is fabricated from 304 grade stainless steel and the complete body is mounted on a strong stainless steel base for sturdiness. A 35-ltr gross volume hopper is provided for feeding is made of SS-304 GR material. Horizontal rotor assembly consists of SS-304, hexagonal rods and SS plates with a main rotor shaft of 25 mm diameter. The grill type removable cover is provided inside hopper. This grill cover protects operator from oscillating rotor and also prevents any accidental dropping of scoop, etc inside operating chamber. A TEFC electric motor is provided along with a suitable reduction gearbox. Jicon Machines Pvt Ltd - Mumbai - Maharashtra Tel: 022-2851 0398, Fax: 022-2851 6488 Email: firstname.lastname@example.org, Website: www.jicon.com
Modern Pharmaceuticals I December 2011
Products Cap sealing machines Konark Machine Tools oďŹ€ers automatic single-/multi-head ROPP cap sealing machines that are compact versatile, selfsupported on stainless steel legs with height adjustable arrangement. These machines are precision built on sturdy welded steel frame completely enclose in stainless steel sheet with doors provided to facilitate the servicing of the machines. The ďŹ eld containers moving on conveyor belt are fed into an in feed star wheel bringing the container below the sealing head in the subsequent indexing port. Features include: no container, no cap arrangement, single motor synchronizes conveyor, star wheel and platform turret, adjustable height of conveyor belt, all contact parts made out of stainless steel, sealing pressure can be varied to suit diďŹ€erent gauges and size of caps, specially designed hopper is provided to increase storage capacity of bowl, low noise level, low power consumptions, star wheel is equipped with safety clutch for automatic stoppage of machine in case of jamming/over loading. Konark Machine Tools - Ahmedabad - Gujarat Tel: 079-2760 2068, Mob: 09374990776 Email: email@example.com, Website: www.konarklabelling.com
December 2011 I Modern Pharmaceuticals
Products Linear vial washing machines Laxmi Industries oﬀers highspeed linear vial washing machines that are totally fabricated from SS materials, including the basic frame. These machines are suitable for handling wash of 5 ml to 30 ml vials without changing parts. They are provided with high-pressure spray nozzles that enter into the vials during washing time. The linear vial washing machines are equipped with safety devices to ensure smooth and silent operation with high rated out put. These have an output capacity ranging from 150 to 250 vials/minute. Also oﬀered are water recycling arrangements as per customers’ requirements. These come with inbuilt SS pumps and SS tanks. The machine structure is made from SS-304 and the tanks, pumps and ﬁlter housing is made from SS-316 materials. Laxmi Industries - Ahmedabad - Gujarat Tel: 079-2289 3810 Email: firstname.lastname@example.org
Starch paste kettles Bombay Pharma Equipments oﬀers starch paste kettles that are specially designed for preparation of binder material.These hemispherical kettles with jacket are mounted on trunion supports with the help of shaft. The kettles have a small cylindrical top shell with a spout for pouring out binder mass. The jacket is provided with steam accessories, pressure gauge, safety valve and vent cock and is equipped with a lever with hand wheel to accomplish tilting manually. These are also provided with 16 SWG thick SS-304 loses lid. The starch paste kettles are made of SS-304/SS-316. They come with anchor type beater for paste mixing. Bombay Pharma Equipments Pvt Ltd - Mumbai Maharashtra Tel: 022-2859 4877, Fax: 022-2852 1608, Mob: 09820124804 Email: email@example.com
Table top coders Process Instrumentation & Controls oﬀers table top coders. These batch coding machines are suitable for all manual and automatic coding on various packing. The easyto-operate coders are compact in design, which makes them easy to install, where space is limited. The table top coders operate on a microprocessor-based system and are equipped with motorised intermittent reciprocal contact
coder. These are used for manufacturers/packers of packaged goods to print batch no, date of manufacturing, expiry date, prices and other statutory information’s on various packaging, containers, labels, cartons, pouches, etc. The coders give bigger printing area up to 50 mm and can easily have 4-6 lines of printing on various packed goods. Process Instrumentation & Controls - Vadodara - Gujarat Tel: 0265-2357228, Fax: 0265-2355429, Mob: 09825139846 Email: firstname.lastname@example.org, Website: www.piccode.com
Strip seals Novoﬂex Marketing oﬀers pilfer-proof strip seals that prevent imitation of branded and quality products and help control adulteration and pilferage, thus protecting a company’s high reputation and brand image. These strip seals 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. The strip seals are lightweight, corrosion-eﬀective, economical and cost-eﬀective. Company’s name/logo can be permanently hot stamped on it. These seals can be used in the pharmaceuticals industries, bulk drugs, airlines baggages, postal department, chemical industries, bank lockers, courier bags, containers, drums, etc. Novoﬂex Marketing Pvt Ltd - Kolkata - West Bengal Tel: 033-2226 0513, Fax: 033-2229 7814, Mob: 09903163634 Email: novoﬂex@vsnl.net, Website: www.novoﬂexgroup.com
Stoppering machines Automated Machine Technologies oﬀers servo rotary stoppering machines that are crafted for cleanroom productions. The compact size allows for a side-by-side conﬁguration, doubling the speed and matching the speed of the liquid ﬁlling machines for over 200 vials per minute side. These systems perform full and partial insertion and can be easily changed over to diﬀerent stopper and bottle sizes. The multi-axis servo systems synchronise stoppers with bottles eliminating the need for diﬃcult mechanical adjustments over years of operations. Vibratory feeder bowl orients and supplies stoppers, and is servodriven for programmable changeover to a diﬀerent bottle height. Automated Machine Technologies Inc - North Carolina - USA Tel: +1-919-3610121, Fax: +1-919-4812120 Email: oﬃce@amtliquidﬁlling.com
Modern Pharmaceuticals I December 2011
Products Bottom discharge centrifuges United Engineering oﬀers bottom discharge centrifuges with cake scrapping arrangements for chemicals, pharma and process industry. These centrifuges are ﬁtted with a cake scrapping arrangement that can be motorised or hydraulically operated to enable to scrape the stickiest cakes. The cake can be discharged through the bottom chute provided. This results in reducing manual labour, less cake handling loss and uniform cake washing. The centrifuges can be oﬀered in vapour tight construction with nitrogen blanketing for hazardous chemicals. CIP design with built-in cleaning nozzles ensures no product cross-contamination. The centrifuges are oﬀered in three point pendulum suspension and four point inertia plate mounted designs to suit application considerations. These are available in MS, SS at point of contacts, complete SS, MS rubber/halar-lined, with batch capacities of 40 kgs to 600 kgs. United Engineering Enterprises, Mumbai 400 011. Tel: 022-2308 3990, Fax: 022-2308 9445 Email: email@example.com, Website: www.united-centrifuges.com
December 2011 I Modern Pharmaceuticals
Products Bar code readers
Banner Engineering India oﬀers iVu bar code readers that read eleven industrystandard bar codes to facilitate advanced traceability, a critical strategy for ensuring the highest product quality in packaging, material handling, automotive, pharmaceuticals and many industrial applications. These bar code readers with an integrated or remote touchscreen, and intuitive interface allow users to eﬃciently conﬁgure, monitor and modify and inspection without a PC or external controller. Salient features include: even ﬁrst-time users can have it up and running in minutes, without training, compact, rugged IP67-rated housing is available with or without an integrated ring light, RS-232 serial communication port is provided for exporting bar code data. Using the touchscreen and intuitive interface, inspection parameters are easily conﬁgured and quickly deployed without a PC or external controller. The sensor is available with a remote touch screen for setup and inspection monitoring. The bar code readers are available with three diﬀerent trigger modes to determine how the sensor captures and processes images.
US Bottlers Machinery Company oﬀers rotary chuck style bottle cappers that are designed to apply and rotate a pre-sorted cap on a container, based on a predetermined applied torque. The containers are fed onto the rotary chuck style capper and are separated and positioned on individual capping stations. Caps are pre-sorted and fed on the sliding table of the machine. Continuously rotating chucks pick up and secure the caps, then apply the caps to the containers. When the preset applied torque value is achieved, the magnetic clutch disengages, the chuck releases the cap and the closed container is discharged from the machine. These are available in several frame sizes, as well as tangential infeed and discharge conﬁgurations. The bottle cappers have magnetic clutches with one point torque adjustment and tool-less, quick release container handling attachments. All drive train components are located inside the machine base.
Banner Engineering India Pvt Ltd - Pune - Maharashtra Tel: 020-6640 5624, Fax: 020-6640 5623, Mob: 09322339208 Email: firstname.lastname@example.org Website: www.bannerengineering.com
US Bottlers Machinery Company - North Carolina - USA Tel: +1-704-5884750, Fax: +1-704-5883808 Email: email@example.com
Rapid mixer granulators
TTL Technologies oﬀers DIPA 2000 particle size and shape analysers from Donner Technologies. These analysers combine two complementary measurement techniques by integrating laser and video channels. They provide complete sample information on particle size distribution and numerous particle shape parameters with the help of very high analytical resolution (analysing each sampled particle individually) and real-time sample visualisation. The analysers have a wide measurement range starting at 0.1 up to 5000 microns. They come bundled with software for comprehensive data analysis and report generation. The instruments can be ﬁtted with a variety of modular measurement cells which can be manually interchanged quickly to allow for particle analysis in liquids, emulsions, creams, dry powders, ﬁbres, heated liquids, aerosols, and more, with minimal (or no) sample intervention and original state analysis. Analytical data can be displayed in a wide variety of tables and graphs.
Avon Pharma Machines oﬀers rapid mixer granulators that are designed to meet the requirements of GMP. The contact parts are made of SS-304/316. These granulators come with specially designed control panel with display system and microprocessor. The bowl, lid mixing agitator and discharge housing are made of stainless steel. Al MS parts of the machine are cladded /covered with stainless steel. Limit switch is provided on main lid and discharge valve for safe operation. Features include: components of the machine are easily accessible for cleaning, all electrical & pneumatic parts are pre-wired to simplify installation. These are provided with impellers that consist of two full and two half solid mixing blades. The specially designed chopper blades are driven at high speed which gives fast and even granulation, throughout the whole mass in the product bowl.
TTL Technologies Pvt Ltd - Bengaluru - Karnataka Tel: 080-2525 1859, Fax: 080-2529 1285 Email: firstname.lastname@example.org, Website: www.ttlindia.com
Avon Pharma Machines Pvt Ltd - Thane - Maharashtra Tel: 0250-245 0638-39, Fax: 0250-245 0640 Email: email@example.com
Particle size & shape analysers
Modern Pharmaceuticals I December 2011
Products Fluid bed dryers Vyanktesh Fabricraft oﬀers ﬂuid bed dryers that are designed to introduce hot-air stream at the base of the product container, which is ﬁlled with materials. Induced draught is created by blower and fresh air is sucked in to the unit. The fresh air is heated by means of electrical heaters or steam or thermic ﬂuid heaters. These dryers perform fully-automatic operation and are provided with lifting and tilting device of product container for easy handling. They require minimum handling and its capacity ranges from 5 kgs to 500 kgs. Flameproof push-button operating station and motors for explosive products, SCADA system, fully-computerised panel, etc, are available as option. Vyanktesh Fabricraft Pvt Ltd - Nashik - Maharashtra Tel: 0253-2383603, Telefax: 0253-6602691 Email: firstname.lastname@example.org Website: www.vyankteshfabricraft.com
The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of
December 2011 I Modern Pharmaceuticals
List of Products Sl No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72
AC drives ...............................................87 AC motors ............................................... 35 AC variable frequency drives .................. 87 Accent lighting systems ........................... 15 Access control systems............................. 77 Acoustic enclosures .................................. 63 Agitators ................................................... 21 Air ﬁlters ............................................ 43, 45 Air shower controllers.............................. 77 Air treatments .......................................... 10 Alpha presses.............................................. 8 Analytical instrumentation ...................... 33 Autoclave gaskets ..................................... 89 Autoclaves .............................................. BC Automatic rescue devices......................... 87 Axial ﬂow fans ......................................... 87 Bar code readers.....................................88 Batch dispersers ....................................... 21 Bearings .................................................... 12 Bioasia-2012 exhibition ........................... 90 Biological safety cabinets ................... 43, 45 Blowers ..................................................... 87 Booklet & leaﬂet labels ........................... 19 Bottle cappers........................................... 88 Bottom discharge centrifuges .................. 87 Braided house........................................... 89 Brake motors ............................................ 35 Cable carriers .........................................12 Cable connectors...................................... 12 Cables ....................................................... 89 Calorimeters ............................................. 21 Cap sealing machines .............................. 85 Capsule ﬁlling machines............ 78, 80, BC Cartoners ................................................ BC Centrifugal air blowers ............................ 87 Centrifugal monoblock pumps ............... 85 Chains ...................................................... 12 Chemical processing equipment ............. 79 Chlorine gas cylinders & tonners ........... 79 Clean attire............................................... 37 Cleanroom apparels ................................. 37 Cleanroom doors ............................... 43, 45 Cleanroom garments ............................... 37 Cleanroom luminaires.............................. 15 Coating machines ...................................... 8 Coating pans ............................................ 80 Coding machines ................................COC Colloid mills............................................... 8 Columns & chemistries........................... 33 Commercial lightings .............................. 15 Comminuting mills ................................... 8 Compressors ............................................. 87 Connectors ............................................... 12 Consumer lightings.................................. 15 Controllers for furnaces ........................... 87 Conveying blowers................................... 87 Cooling towers ......................................... 10 Cords ........................................................ 89 Corona treater sleeves .............................. 89 Counters & power supplies ....................... 6 Crushers ..................................................... 7 DC motors ............................................35 Dedusting & deburring machines ............ 8 Dehumidiﬁers .......................................... 81 Dispensing booths ............................. 43, 45 Dispersers ................................................. 21 Disposable bioreactors ............................. 80 Door interlock systems ............................ 77 Double rotary tableting machines ............. 8 Dry vane pumps ...................................... 63 Drying ovens .............................................. 8 Duo labels ................................................ 19
Sl No 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143
Dust collector systems ............................. 87 Dust extractors ........................................... 8 Electricals - HT & LT ..........................77 Electronic brakes...................................... 87 Electronic chlorine dosing systems/chloroscopes ............................. 79 Elevator controllers .................................. 87 Emergency lighting systems .................... 15 Empowers................................................. 33 Encoders ..................................................... 6 EngineeringExpo exhibitions .................. 26 Exhibitions ......................................... 26, 90 Factory automation .......................... BGF Fan ﬁlter units.................................... 43, 45 Fans .......................................................... 87 FBD gaskets............................................. 89 Filling machines ....................................... 85 Filters .......................................................... 7 Filtration equipment .................................. 7 Filtration systems ....................................... 7 Fire alarms ................................................ 77 Flag labels................................................. 19 Flameproof motors .................................. 35 Flange mounting motors ......................... 35 Flood lighting systems............................. 15 Fluid bed dryers ....................................... 89 Fluid bed processors .................................. 8 Fluid bed systems ...................................... 8 Food analysing & testing machines.......... 7 Fuel burners.............................................. 87 Gas chlorinators ....................................79 Gas conditioning & ﬁre protection ........ 31 Gaskets ..................................................... 89 Geared boxes ............................................ 55 Geared motors ......................................... 55 Giga presses................................................ 8 Gravity & vacuum feeding systems ........ 79 Gravity feed metal detectors ................... 78 Hanger labels .........................................19 Heating baths........................................... 21 Hepa ﬁlter terminal housings............ 43, 45 High eﬃciency mills................................ 85 High pressure homogenisers ................... 21 Hospital bedlights.................................... 15 Hot plates................................................. 21 HPLC ...................................................... 33 Industrial control & sensing devices ........6 Industrial coolers ...................................... 10 Industrial lighting systems....................... 15 Inﬂatable gaskets ...................................... 89 Informatics ............................................... 33 Injectable manufacturing lines .......... 43, 45 Inline dispersers ....................................... 21 IntegrityPlus attires.................................. 37 Inverter/variable frequency drives ............. 6 Kneading machines................................21 Knife mills .................................................. 7 Labelling machines ...........................COC Laboratory mills....................................... 85 Laboratory products................................. 81 Laboratory reactors .................................. 21 Laboratory software ................................. 21 Laminar air ﬂow workstation ............ 43, 45 Landscape lighting systems ..................... 15 Level controllers......................................... 6 Linear vial washing machines ................. 86 Liquid food processing machines.............. 7 Liquid sterile ﬁlling machines ............... BC Liquid-ring vacuum pumps..................... 87 Magnetic stirrers....................................21 Marking machines ..............................COC Mass mixer granulators ............................. 8
Sl No 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213
Measuring & monitoring relays................ 6 Mega presses .............................................. 8 Mills.......................................................... 21 Mini CM mills .......................................... 8 Mini roll compactors ................................. 8 Motion controls ......................................... 6 Motors ...................................................... 35 Mullers ....................................................... 7 Multi-function mills .................................. 7 Multistage centrifugal air blowers ........... 87 Nano mills .............................................85 Oil seals .................................................89 Oil/gas ﬁring equipment ......................... 87 Online b2b marketplace .................... 23, 91 O-rings ..................................................... 89 Oscillating granulators ............................. 82 Overhead stirrers...................................... 21 Particle size & shape analysers ..............88 Pass box interlock systems....................... 77 Pass boxes ........................................... 43, 45 PBEGL geared motors ........................... 35 Pharma lighting systems ......................... 15 Photoelectric sensors.................................. 6 Pilot plants ............................................... 21 Pilot presses (10-stn) ................................. 8 Pneumatic components.............................. 7 Pneumatic conveying systems ................. 87 Portable loaders ........................................ 87 Power controllers...................................... 87 Pre-engineered & pre-fabricated modular panels ................................ 43, 45 Proﬁles ...................................................... 89 Programmable logic controllers................. 6 Programmable terminals............................ 6 Proximity sensors ....................................... 6 Pumping ﬁltering units ........................... 87 Pumps................................................. 63, 87 Punches & dies .......................................... 8 Pure steam generators............................ BC Quick-change terminal houses ........ 43, 45 Rapid endotoxin detection system .........77 Rapid mixer granulators .......................... 88 Rapid mixers .............................................. 8 Return air risers.................................. 43, 45 RFID systems ............................................ 6 Road lighting systems.............................. 15 Roll compactors ......................................... 8 Roots blowers ........................................... 63 Rotary evaporators ................................... 21 Rotary gear pumps................................... 85 Rotary lobe pumps................................... 85 Rotary vacuum dryers .............................. 82 Safe change housings ....................... 43, 45 Safety light curtains ................................... 6 Sampling booths ................................ 43, 45 Sanitary centrifugal systems .................... 85 SCR power controllers ............................ 87 Screening machines ............................. 7, 79 Screw pumps ............................................ 85 Screwless cleanroom luminaires .............. 15 Sections .................................................... 89 Self-adhesive tapes ................................... 89 Self-priming monoblock ......................... 85 Separators ................................................... 7 SEZ developers ....................................FGF Shakers ..................................................... 21 Sheets ....................................................... 89 Side-channel blowers ............................... 87 Sieves ........................................................ 80 Silicone rubber sleeves ............................. 89 Silicone transparent platinum cured tubings ......................................... 89
Sl No 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263
Single rotary tableting machines ............... 8 Slipring crane-duty motors ..................... 35 Soft starters & digital starters ................. 87 Solid-liquid mixers................................... 21 Sponges .................................................... 89 Spray analysis ........................................... 31 Spray control systems .............................. 31 Spray fabrication machines...................... 31 Spray nozzles & accessories .................... 31 Squares ..................................................... 89 Starch paste kettles .................................. 86 Sterilising & depyrogenating tunnels............................................... 43,45 Sticker labeling machines ........................ 77 Stoppering machines ............................... 86 Strip seals ................................................. 86 Strips......................................................... 89 Submersible pumps.................................. 85 Switching relays ......................................... 6 Table top coders.....................................86 TC gaskets ............................................... 89 Technical garments .................................. 37 Tefzel hhs isotactic PP material.............. 17 Temperature controllers ............................. 6 Thermoplastic valves & piping systems .................................................. 17 Thermostats & vacuum dryers/mixers .... 21 Three parameter displays ......................... 77 Timers ........................................................ 6 Transparent tubings ................................. 89 Tray dryers................................................ 78 Trim handling systems ............................ 87 Triplex plunger pumps............................. 85 Turnkey systems for dust suppression..... 31 UPLC systems .......................................33 Vacuum booster pumps .........................63 Vacuum pool systems............................... 78 Vacuum pumps .................................. 81, 87 Vacuum systems ....................................... 63 Vacuum tray dryers .................................. 82 Vane dampers ........................................... 87 Variable frequency drives......................... 87 Ventilators ................................................ 89 Vertical inline ........................................... 85 Vision sensors & surface inspection systems ..........................................51, BIC Vision sensors............................................. 6 Vision software ...............................51, BIC Vision systems.................................51, BIC Wastewater treatment equipment ............7 Water for injection generation stills...... BC Water-ring vacuum pumps & compressors ............................................. 82 Water-ring vacuum pumps...................... 87
Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.
BC-Back cover, BGF-Back Gate Fold, BIC-Back inside cover, COC-Cover on cover, FGF-Front gate fold, FIC-Front inside
December 2011 I Modern Pharmaceuticals
List of Advertisers Advertiser’s Name & Contact Details
Aqua Services T: +91-265-2331748 E: email@example.com W: www.aquaservicesindia.com
Arctic India Sales T: +91-11-23906777 E: firstname.lastname@example.org W: www.bryair.com
Bosch Limited T: +91-80-41768218 E: narendra.S@in.bosch.com W: www.boschindia.com/pa
C P K Engineers Pvt Ltd T: 91-40-23735424 E: email@example.com W: www.cpkengineers.com
Chamunda Pharma Machinery Pvt Ltd T: +91-79-25842712 E: firstname.lastname@example.org W: www.cm1981.com Charles River
Advertiser’s Name & Contact Details
Federation Of Asian Biotech Assoc T: +91-40-66446477 E: email@example.com W: www.2012.bioasia.in
Gem Equipments Ltd
E: firstname.lastname@example.org W: www.gemindia.com
W: www.premiumtransmission.com Reynders Label Printing India Pvt Ltd 7
Igus India Pvt Ltd
E: email@example.com W: www.criver.com
E: firstname.lastname@example.org W: www.indiamart.com J B Sez Pvt Ltd
Cognex Sensors India Private Limited 51,BIC T: +91-80-40224118 E: email@example.com W: www.cognex.com/trackandtrace
E: firstname.lastname@example.org W: www.jbsez.com
Dev Engineers T: +91-79-26403839 E: email@example.com W: www.devpumps.com
Jeltron Systems (India) Pvt Ltd T: +91-40-23401159 E: firstname.lastname@example.org W: www.jeltron.com
Eltech Services Pvt Ltd
Markem-Image India Private Limited COC T: +91-120- 4099500 E: email@example.com W: www.markem-imaje.co.in
Milltech Engineering Pvt Ltd
E: firstname.lastname@example.org W: www.eltechservices.com
Engineering Expo T: +91-09819552270 E: email@example.com W: www.engg-expo.com
Everest Blowers T: +91-11-45457777 E: firstname.lastname@example.org W: www.everestblowers.com
Fabtech Technologies Intl Pvt Ltd T: +91-22-61592900
E: email@example.com W: www.fabtecheng.ae
Spraying Systems (India) Pvt Ltd T: +91-80-39853200 E: firstname.lastname@example.org W: www.spray.com
Suresh Enterprises T: +91-2762-224814 E: email@example.com W: www.sevitsil.com
The Indian Electric Co T: +91-20-24474303 E: firstname.lastname@example.org W: www.indianelectric.com
UNP Polyvalves India Pvt Ltd T: +91-265-2649248 E: email@example.com W: www.polyvalve.com
Vacunair Engineering Co Pvt Ltd T: +91-79-22910771 E: firstname.lastname@example.org W: www.vacunair.com
Waters (India) Private Limited
E: email@example.com W: www.waters.com
E: firstname.lastname@example.org W: www.milltechengg.com Misumi India Pvt Ltd
E: email@example.com W: www.sreelakshmitraders.com
E: firstname.lastname@example.org W: www.ika.in IndiaMART InterMESH Limited
E: email@example.com W: www.reynders.com
IKA India Private Limited
Premium Transmission Ltd
Guan Yu Machinery Factory Co., Ltd.
E: firstname.lastname@example.org W: www.plusventilation.com
E: email@example.com W: www.igus.in
Plus Ventilation Pvt Ltd
E: firstname.lastname@example.org W: www.guan-yu.net
Advertiser’s Name & Contact Details
E: email@example.com W: http://in.misumi-ec.com Omron Automation Pvt Ltd
E: firstname.lastname@example.org W: www.omron-ap.com 43,45
Perlite India Pvt Ltd T: +91-79-22782623
Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818
eg, MPH (space) Bioreactor and E: email@example.com send it to 51818. W: www.pierlite.co.in Our consistent advertisers BC-Back cover, BGF-Back Gate Fold, BIC-Back inside cover, COC-Cover on cover, FGF-Front gate fold, FIC-Front inside cover
Modern Pharmaceuticals I December 2011
RNI No: MAHENG / 2008 / 27125 Postal Regd No: G / NMD / 122 / 2011 - 13 Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month Date Of Publication: 16th Of Every Month
Modern Pharmaceuticals is a leading monthly business magazine in India, catering to the pharmaceutical industry. Published by Network 18 Ltd...
Published on Nov 30, 2011
Modern Pharmaceuticals is a leading monthly business magazine in India, catering to the pharmaceutical industry. Published by Network 18 Ltd...