Issuu on Google+

16 - 3 0 J u n e 2 013 I Vo l 1 I N o 24 I ` 1 0 0

www.modernpharma.in

Scan this code on your smart phone to visit www.modernpharma.in

In Conversation With 12

Special Focus 13

Roundtable 16

Event Report 23

Dr Sharad Kasarle Chief Scientist, DSK Nutrition Research Center Pvt Ltd

Generic injectables On a growth trajectory

Are strict regulatory compliances responsible for supply shortage and manufacturers’ withdrawal from injectables?

SCDM Asia Conference 2013 Revolutionising clinical data management

Apollo Pharmacy stops sale of Ranbaxy drugs Apollo Pharmacy follows the recommendations of its medical committee and has halted sales of Ranbaxy medicines at its outlets. After the recent event of Ranbaxy, Indian government has launched investigations. According to a previously disclosed investigation by the US Department of Justice of data integrity and manufacturing processes at certain Ranbaxy facilities in India, it found the company flouting norms. Ranbaxy’s Japanese owner Daiichi Sankyo even mulled dragging former shareholders to court for reportedly ‘misrepresenting critical information.’

Sweden’s Meda AB denies acquisition talks with Sun Pharma Swedish drug firm  Meda AB, known for speciality products, over-thecounter drugs and branded generics, denied reports of acquisition plans with Sun Pharma for $ 5 billion. “Due to the recent speculation in the press and news media concerning Meda merging with another pharmaceutical company, we have decided to inform the market that there are currently no such discussions.  Meda’s policy is not to comment on speculation and will not do so in the future. This announcement is an exception to our policy,” Meda said in a statement. While a spokesperson of Sun Pharma had earlier refused to comment on the reports, the Mumbaibased firm also announced that reports of a possible deal were ‘speculation.’

NPPA starts fixing price of 348 essential drugs The National Pharmaceutical Pricing Authority (NPPA) has started fixing the price of 348 essential drugs that are under the Drug Price Control Order (DPCO) of the year 2013. The agency has asked State Licensing Authorities (SLAs) to provide the list of manufacturers operating and producing these drugs in their territories. This move will allow NPPA to collect the latest information and data related to company turnover, market share, and sales of certain drugs enlisted under DPCO. According to some industry sources, the 45-day time period is short, for implementation of new ceiling price. DPCO 2013 became effective from 15 May, 2013 and replaced the 1995 order bringing 348 drugs under price regulation, as compared to 74 drugs previously, on the basis of nominal market price of a drug.

Parker Hannifin India expands national presence Parker Hannifin, one of the leaders in motion and control technologies, expands its national presence with the opening of a new ParkerStore in Chennai by FEC India Pvt Ltd. This new ParkerStore will offer a wide range of pneumatic, hydraulic, seals and filtration products and components. Viren Patel, President, FEC India Pvt Ltd, explained “Representing Parker as an exciting new venture will enable us to expand our existing services for low and high pressure hoses and couplings with a complementary business unit. We believe this will open up many new opportunities in the future.”

Sankar Vishwanath, Business Development Manager, ParkerStore - India, added, “The ParkerStore programme offers all our distribution partners, a proven business model that, they can develop for use in their local areas. It offers real value for both, the store operators and their customers by bringing Parker technology and expertise within the easy reach of L-R: Viren Patel and Arijit Sen, Country Managing everybody involved in the field of Director, Parker Hannifin India Pvt Ltd motion and control.” With annual sales exceeding of motion and control technologies $ 12 billion, Parker Hannifin is one of and systems, providing precisionthe leading diversified manufacturers engineered solutions.

Zydus Cadila introduces novel anti-diabetic drug, Lipaglyn™ The Zydus group has announced a breakthrough in its research efforts with Lipaglyn™ (Saroglitazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic dyslipidemia or Hypertriglyceridemia in Type II diabetes, which cannot be controlled by statins alone. The drug has been approved by the Drug Controller General of India (DCGI) for its launch in the country. This drug performs a novel action that offers lipid and glucose lowering effects in one molecule. Lipaglyn™ is the first Glitazar to be approved anywhere in the world. “Lipaglyn™provides patients suffering from diabetic dyslipidemia, the option of once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control,” said Pankaj R Patel, Chairman and Managing

Director, Zydus Cadila. “It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realised this dream. It is an important breakthrough, and I would like to dedicate this to all Indian research scientists in the field of drug discovery.” The new drug application for Lipaglyn™ was based on a comprehensive clinical development programme Phase-I, Phase-II and Phase-III clinical trials, spanning eight years. Results from the first Phase III programme with Pioglitazone as a comparator drug in diabetes patients showed that the 4 mg dose of Lipaglyn™ led to a reduction of triglycerides and LDL cholesterol, and an increase in HDL cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c) thereby confirming its

beneficial effects of both lipid and glycemic control in diabetic patients. Lipaglyn™ is recommended as 4 mg tablets. Almost 85 per cent to 97 per cent of all diabetics are estimated to suffer from diabetic dyslipidemia. Lipaglyn™- a non-thiazolidinedione, is the first therapy to be approved for this condition. The company has spent $ 250 million in developing Lipaglyn which took nearly 12 years to fructify. It will be spending another $ 150 - $ 200 million to launch the drug in overseas markets in next 3-5 years period, Patel said. In India, the company expects Lipaglyn, indicated for treating ‘Diabetic dyslipidemeia,’ to clock an annual turnover of ` 100 crore in the next 3-4 years. With the current success, Zydus is on track towards its target of becoming a $ 3-billion entity by 2015 from the current $ 1.4-billion.

Advanced form of microscopy to boost nanomedicine development Professor Dr M N V Ravi Kumar and Dr Dimitrios Lamprou, of the Strathclyde Institute of Pharmacy and Biomedical Sciences, believe an advanced form of atomic force microscopy, known as PeakForce QNM, could boost developments in the field of nanomedicines, the encapsulation of potent drugs in tiny particles measuring billionths of a metre in diameter. They described how this detailed imaging approach may also help scientists address growing concerns in the medical world around ‘nanotoxicology’, the build-up of microscopic particles in people’s tissues. Prof. Kumar, whose team’s research article has been published in the journal PLOS ONE, said, “Nanotechnology’s role in drug delivery has the power to transform the way patients are given medicines over the next decade or so. The good thing about nanomedicines is

that, unlike traditional tablets and capsules, the drugs are not released in the gut. Instead, nanomedicines are absorbed intact and the encapsulated drugs are released directly into the bodily tissues, including the blood. This offers the possibility to reduce the required dosage without compromising on the therapeutic effects.” The excipients such as polymers, used to formulate the nanoparticleencapsulating drugs may exhibit undesired effects when directly absorbed through the gut wall. Scientists are keen to discover, if nanoparticle-based drugs have adverse effects on patients and in particular, if they cause more harm than good in some cases. Till now, very little has been known about what happens after nanoparticles circulate throughout the body and if they raise any safety issues for the patient. Previously, it was necessary for

nanoparticles to be given a fluorescent or radioactive label, in order to allow scientists to be able to identify and track them. However, by using PeakForce QNM atomic force microscopy, nanoparticle movement can be tracked as it circulates throughout the body, after oral administration. This can be made possible without attaching any fluorescent or radioactive labels and by using the real drug loaded nanoparticles. In particular, accumulation of nanoparticles in specific areas can be identified easily, thereby detecting causes of ‘tissue stiffness’ – a condition linked to variety of diseases, including cancer. Additionally, recent studies using atomic force microscopy have shown that, it is possible to distinguish between nonmalignant and malignant tumours cells, on the basis of their relative stiffness.


0RGHUQ3KDUPD‡-XQH

CONTENTS In Conversation With

12

Dr Sharad Kasarle Chief Scientist, DSK Nutrition Research Center Pvt Ltd

12

13

15

19

Special Focus Parenterals/Injectables Generic injectables On a growth trajectory Novel drug delivery systems New target therapies in injectables

13 14

Interface Ashutosh Jain COO, Venus Pharma GmbH

15

Roundtable Are strict regulatory compliances responsible for supply shortage and manufacturers’ withdrawal from injectables?

16

www.modernpharma.in

Insight & Outlook Policies & Regulations: Section 3(d) of the Indian Patent Act Upholding the standards of innovation

19

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan

Event Report SCDM Asia Conference 2013 Revolutionising clinical data management

23

EDITOR-IN-CHIEF, WEB & PUBLISHING R Jagannathan SENIOR EDITOR Manas R Bastia EDITORIAL TEAM Parita Dholakia, Savita V Jayaram, Pallavi Mukhopadhyay, Anubhav Sharma, Rishab Kothari, Nikunj Sharma (Delhi), Hardik Ashar (Bengaluru) ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan CHIEF PHOTOGRAPHER Mexy Xavier PHOTOGRAPHY Joshua Navalkar, Nachiket Gujar BUSINESS CONTROLLERS Surekha Karmarkar, Lovey Fernandes, Akshata Rane, Deepak Bhatia, Ashish Kukreti, Shwetha ME, Jayashree N, Sugandha Kulkarni, Shefali Mahant, Varsha Nawathe

PRODUCTION TEAM

REGULAR SECTIONS 5 Editorial / Guest Editorial 7 News, Views & Analysis 19 Projects 20 Tenders 22 Event List

USA Tel: (513) 527-8800 Fax: (513) 527-8801 Email: dhight@gardnerweb.com

29 Marketplace 30 List of Products & Advertisers 1 st A N N I V

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: craig@ringier.com.hk 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: octavia@ringier.com.hk 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: sydneylai@ringier.com.hk GERMANY, AUSTRIA, SWITZERLAND Tel: +41-44 734 0472, Fax: +41 44 734 0680 Email: info@islerannoncen.ch

25 Products

AR

OVERSEAS CONTACT

Ringier Trade Media Ltd

Ringier Trade Media Ltd

24 Book Review

S ER

Surekha Karmarkar, Ravikumar Potdar, Ravi Salian, Sanjay Shelar

Y S P EC I A L

Highlights of next edition Special Focus: Logistics

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

USA Alfredo Domador, 6505 Blue Lagoon Drive, Suite 430 Miami, FL. 33126, USA Tel: (305) 448-6875, Fax: (305) 448-9942

GROUP CEO, NETWORK 18 B Sai Kumar CEO-NETWORK 18 PUBLISHING Sandeep Khosla EVP-HUMAN RESOURCES Sanjeev Kumar Singh ASSOCIATE VICE PRESIDENT Sudhanva Jategaonkar ADVERTISING SALES Shashin Bhagat (Ahmedabad) shashin.bhagat@network18publishing.com Mahadev B (Bengaluru) mahadev.b@network18publishing.com Hari Hara Subramaniam (Chennai) hari.s@network18publishing.com Balakrishnan S (Coimbatore) balakrishnan.s@network18publishing.com Surendra Agarwal (Delhi) Surendra.a@network18publishing.com Sunil Dakur (Hyderabad) dakur.sunil@network18publishing.com Ameya Gokhale (Indore) ameya.gokhale@network18publishing.com Sandeep Arora (Jaipur) sandeep.arora@network18publishing.com Abhik Ghosal (Kolkata) abhik.ghosal@network18publishing.com Inder Dhingra, Surajit Bhattacharjee (Ludhiana) inder.dhingra@network18publishing.com surajit.b@network18publishing.com Surajit Bhattacharjee surajit.b@network18publishing.com Olwin Dsouza (Mumbai) olwin.dsouza@network18publishing.com Rohit Dass (Pune) rohit.dass@network18publishing.com Vipul Modha (Rajkot) vipul.modha@network18publishing.com Chirag Pathak (Vadodara) chirag.pathak@network18publishing.com MARKETING TEAM Ganesh Mahale, Akshaya Jadhav

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 chaitali.parkar@network18publishing.com or call +91 22 30034631-34 or toll free 1800 200 1021 PERMISSIONS

For subscription to copy or reuse material from Modern Pharma, Write to spedit@network18publishing.com ‡)RUWQLJKWO\,VVXH3ULFH` 100 ‡$QQXDO6XEVFULSWLRQ` 1200

Views and opinions expressed in this magazine are not necessarily those of Network18 Media & Investments Ltd (Network18)*, its publisher and/or editors. We at Network18 do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. Network18 does not accept the responsibility for any investment or other decision taken by readers on the basis of information provided herein. Network18 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. Network18 reserves the right to use the information published herein in any manner whatsoever.

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18. 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 Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 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. *Ownership of this magazine stands transferred from Infomedia18 Ltd (Infomedia18) to Network18 Media & Investments Ltd (Network18) in pursuance of the scheme of arrangement between Network18 and Infomedia18 and their respective shareholders and creditors, as approved by the Hon’ble High Court of Delhi and the necessary approval of Ministry of Information and Broadcasting is being obtained.


0RGHUQ3KDUPD‡ -XQH

Editorial

5

Pharmacovigilance: Extending its ambit he critical quotient of quality, safety and efficacy cannot be overemphasised, when ascertaining the value proposition of pharmaceuticals. While these constitute the success ingredients of a pharmaceutical product, the proactive role of regulatory authorities and expert advisory bodies can go a long way in ensuring a perfect balance between its safety and effectiveness to the end-users. As the focus on the risk-benefit profile of medicines grows globally, the new pharmacovigilance legislation - enacted in 2010 and implemented in July 2012 - has added a new dimension to the risk management of pharmaceuticals in Europe and more responsibilities to the industry as a whole. In this context, an IHS study ‘European pharmacovigilance reform: Strategic implications of ongoing benefit-risk assessment across the product lifecycle’ offers insightful information on the new pharmacovigilance legislation. With detailed analysis in terms of Post-Authorisation Efficacy Studies (PAES) / Post-Authorisation Safety Studies (PASS), it provides an assessment of the next stage of evolution of this framework, while considering the growing activity at the payer-regulatory interface. On the basis of extensive secondary research and primary research with inputs from key stakeholders, this study sheds light on the following important aspects: Implications for pricing and reimbursement Potential cost implications of PASS/PAES, and lessons that can be drawn in terms of investment strategy The contours of a successful market launch in the new pharmacovigilance landscape, and the need for current launch strategies to be modified

T

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

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Takeaways from current legislation and related guidance on the future of PASS/PAES For beginners, company-derived pharmacovigilance data includes adverse reaction case reports, periodic safety update reports and company sponsored postauthorisation studies. It is imperative for the marketing authorisation holder to continually evaluate the pharmacovigilance data and ensure that the marketing authorisations are maintained to provide updated information. Additionally, the marketing authorisation holder needs to operate appropriate pharmacovigilance and risk management systems, in accordance with the mandated responsibility for marketed pharmaceutical products and take prompt action, if and when deemed necessary. It can be inferred that, thanks to such new pharmacovigilance legislations, the legal grounds of a request made by competent authorities, for post-authorisation studies are being strengthened. What’s more, the designated authorities can request PASS or PAES, either as a condition of marketing approval or to ascertain the risk-benefit balance, at any point of time after licensing. Going forward, the pharmaceutical industry will do well by grasping and monitoring the evolving post-authorisation activities to fine tune strategies for successful product development and achieve greater market reach.

Manas R Bastia manas@network18publishing.com

Guest Editorial

Growth of the global injectable drug delivery market: Evolve or perish he fiercely competitive and rapidly growing global injectable drug delivery landscape is no place for the faint-hearted. In a market that is expected to double its revenues to $ 40 billion in the next few years, with an increase of 14 per cent CAGR1, the need for competitive advantage just hit warp-speed. Additionally, a current growth gap of $ 50 billion2(2012) exists in the pharmaceutical market. This gap is expected to widen by an additional $ 502 billion by 2017, meaning big businesses need to increase revenues by $ 100 billion to bridge the cavernous gap. These are interesting times for the global injectable drug delivery industry but, it is not simple to ride the wave of growth and reap rewards at the other end. A better educated, more fastidious and empowered bunch – are firmly pronouncing their sober wishes for healthcare and all that it encapsulates. Demands for a cheaper, faster, stronger, less-painful, more-effective, recyclable products and technologies are high on the market’s agenda. Biotechnology and medical technology companies have no choice but, to evolve

T

and build their competitive advantage if, they want to have any chances of reaping the benefits of this rapidly growing market. It is within this state of flux that, a huge opportunity exists for industries to be innovative, flexible and responsive to market demands. A collaborative and investigative approach could be beneficial. Indeed, building avenues for effective communication with key stakeholders could be crucial to unlocking valuable market potential and consumer insights. Gleaning powerful information from interactions such as these, and leveraging it successfully, could be the difference between gaining a competitive advantage (and the revenue that comes with it) or not. Moreover, the potential for competitive advantage is exaggerated when only few are willing to go the extra mile, to access these valuable market insights. To make things even more interesting for the injectable drug delivery industry, a few more curve balls have been thrown in for good measure. Factors such as prolific budget cuts, diminishing available resources, cheaper device and formulation pricing, resulting in reduced revenues have kept businesses on their toes. With fewer growth options, the pursuit of competitive advantage and

1Global Injectable Drug Delivery Technologies Markets – Global Forecast to 2017. April 2013.http://www.marketsandmarkets.com/Market-Reports/ injectable-drug-delivery-market-150.html. Accessed 10/5/2013.

the craving to ride the growth wave and ultimately survive, many companies have turned to internal artificial selection. Fundamental changes such as selling off non-strategic assets, and consolidating revenue-generating assets, to free up precious working capital have become a common place. But unprecedented actions, however drastic, are arguably a small price to pay, to build competitive advantage and conserve their cash position over the long-term. As long as businesses are prepared to evolve and embrace innovation, with speed and agility in the rapidly growing market, the opportunity for growth and success is huge. Businesses must explore possibilities beyond the traditional square and find novel ways of meeting market demands, if they wish to survive, let alone thrive. Now is the time to be innovative, collaborative, responsive, seek out opportunity, grow organically and leverage off the subtle insights offered by an educated and empowered market. The implications of sticking with the status quo are far less appealing. The choice is up to you: Are you prepared to evolve or are you going to perish? Elaine Carr Director, Telezon Ltd

2Big pharma under pressure for M&A to close US$100b growth gap.Press Release San Francisco,

7 January 2013. http://www.ey.com/GL/en/Newsroom/News-releases/News_Big-pharma-underpressure-for-M-and-A-to-close-US-100b-dollars-growth-gap. Accessed 10/5/2013.


0RGHUQ3KDUPD‡ -XQH

News, Views & Analysis

Oaktree Capital acquires majority stake in Cogent Glass Oaktree Capital Management, a Los Angeles-based investment firm, acquired a majority stake of about 60 per cent in Cogent Glass Ltd for an estimated value of ` 200 crore. Cogent was founded by a group of Indian promoters in 2010. The company has recently set up a world-class plant in Addakal, near Hyderabad to produce high-quality moulded Type I glass vials, as well as tubular glass vials and ampoules for the pharmaceutical industry. The plant is equipped with leading-edge technology and equipment. It is now

the first plant in the world to successfully produce both moulded glass vials and tubular glass vials from single furnace. The plant is also vertically integrated with the latest-generation automated converting equipment to convert the tube into vials and ampoules. Commenting on this acquisition, Jean Rollier, Senior Vice President, Oaktreesaid,“We are particularly pleased to invest in Cogent, because it provides us an entry into the fastgrowing Indian market for pharmaceutical packaging.

The investment in Cogent together with our previous investment in SGD, the world’s leading manufacturer of glass for the pharmaceutical and cosmetic industries, reaffirms our belief that this sector will provide dynamic opportunities for growth globally.” SGD, a France-based manufacturer of glass packaging with operations in Europe, North and South America, and China has also signed a cooperation agreement with Cogent to provide support for technology sharing, marketing and management.

South African regulators claim Ranbaxy drugs ‘safe’ Generic drugs distributed in South Africa by Ranbaxy are ‘safe’ and ‘efficacious’, the country’s regulator body said. This statement follows days after, the beleaguered drug maker paid a fine of $ 500 million in the US for selling adulterated drugs.. The South African subsidiary of India’s largest pharmaceutical company also issued a similar statement, assuring the public that drugs manufactured locally are safe. “We are confident that drugs currently available in

the market are safe, efficacious and of quality,” said Mandisa Hela, Registrar of the South African Medicines Control Council (MCC). Hela said representatives from the regulator and those from the World Health Organization (WHO), the UK Medicines and Healthcare Products Regulatory Agency and the Australian Therapeutic Goods Authority, have inspected Ranbaxy’s manufacturing sites. They were satisfied with Ranbaxy’s improved standards.

This assurance comes in the wake of the drug maker having paid a fine of $ 500 million in the US for reportedly falsifying data and selling sub-standard drugs, manufactured at two of its plants in India. Ranbaxy USA had pleaded guilty to three felony counts under Federal Food Drug and Cosmetics Act (FDCA), and four felony counts for knowingly making, materially false statements to the Food and Drug Administration (FDA).

Thermo Fisher Scientific releases new small benchtop centrifuge Thermo Fisher Scientific Inc, has launched the new small benchtop centrifuge to deliver in a compact footprint, the flexibility to adapt to evolving clinical and research needs that include clinical chemistry, cell culture, microbiology and haematology. The small benchtop centrifuge is designed for solid reliability and consistent results, such as to reduce the amount of downtime and costly bottlenecks during the separation process. “Centrifuges are critical laboratory resources that are in constant use and demand. It is crucial to avoid bottlenecks in these lab workflows, as this

could create unwanted downtime and negatively impact users’ work,” said Maurizio Merli, Product Director, Thermo Fisher Scientific. “With features designed to optimise simplicity, safety and flexibility, the small benchtop centrifuges will help scientists save time and maximise resources in busy labs and clinics.” These small benchtop centrifuges provide application flexibility, cleaning convenience, and ease-of-use with Thermo Fisher Scientific auto-lock rotor exchange. It provides versatility to spin blood tubes, conical tubes, microtubes and microplate compatibility with sealing options.

Fujifilm and Dr Reddy’s to terminate MoU for generic drugs in Japan Fujifilm Corporation and Dr Reddy’s Laboratories Ltd have decided to terminate their Memorandum of Understanding (MoU), to establish a joint venture in the generic drug business in Japan. Based on the MoU signed on 28 July, 2011, the companies had conducted detail studies on the establishment of a joint venture for developing and manufacturing generic drugs in Japan. However, as Fujifilm realigns its long-term growth

strategy for the pharmaceutical business, both companies have decided to terminate the MoU. Commenting on the development, G V Prasad, Chairman and CEO, Dr Reddy’s said, “Unfortunately, we will not be able to partner with Fujifilm specifically for generic formulations business in Japan. However, I want to reinforce our commitment towards a planned entry into Japan to bring affordable and innovative drugs to more patients worldwide.”

7


8

0RGHUQ3KDUPD‡ -XQH

News, Views & Analysis

ISPE-CCPIE China Conference 2013 to be held concurrently with CHINA-PHARM 2013 in Shanghai Recently, the organising committee of the ISPECCPIE China Conference 2013 announced that this year’s conference will be held at Shanghai New International Expo Centre between 29-31October, 2013,

officials from provincial and municipal food and drug administration as well as Good Manufacturing Practice (GMP) inspectors at various levels. In partnership with CCD again, this year’s conference

in this regard, along with other attendees, as well as raise issues of common concern. Since 2013, the State FDA has taken many measures to put the newly-revised drug GMP into practice. The

in parallel with CHINAPHARM 2013. The ISPE-CCPIE China Conference 2012 received great support from the Centre for Certification of Drug of the State Food and Drug Administration (CCD). Over 600 people attended the conference, including top executives from renowned pharmaceutical companies, executives of pharmaceutical equipment enterprises,

will focus on subjects related to the newly-revised GMP and invite famous business executives and officials from provincial and municipal CCD to deliver keynote speeches on GMP and new production processes. The CCD will designate experts to introduce up-to-date achievements in GMP certification, explore management readjustments

column on ‘Newly-revised drug GMP’ on its website, publishes enterprises that have passed the certification nationwide. The ISPECCPIE China Conference 2013 will support the efforts related to implementing the newly-revised drug GMP, expand publicity campaigns, influence and contribute towards realising the certification goal at the earliest.

Biogen Idec organises rally in 11 Indian cities to commemorate World MS Day To commemorate World Multiple information pamphlets at parks, Sclerosis (MS) Day, Biogen Idec local market and busy streets. India observed World MS day With the theme message being, in India through interactive and ‘Together let’s fight MS,’ healthcare educative road shows across the providers were made aware about country. As part of this initiative, employees rallied across 11 different cities viz; Gurgaon, Faridabad, Delhi, Ahmedabad, Kolkata, Mumbai, Bengaluru, Chennai, Hyderabad, Cochin and Pune to educate people about Biogen Idec India team observes world MS day Multiple Sclerosis (MS) and express solidarity with the significance of the day and people suffering from MS. importance of early diagnosis. The day of service was designed The aim of the initiative was to to increase the role of employee raise awareness of MS, solicit volunteerism with focus on public support for improving patients, healthcare providers and opportunities & outcomes for local communities. Biogen Idec MS patients and create an employees interacted with the environment where people can local community and distributed understand MS better.

CCI gives positive nod to the Mylan-Unichem deal

The Competition Commission of India (CCI) has approved pharma firm, Mylan Laboratories’ acquisition of a manufacturing facility owned by Unichem Laboratories, saying that the deal will not have any adverse impact on the competition. The proposed deal includes, Mylan acquiring the newly established manufacturing facility located in a Special Economic Zone (SEZ) in Dhar district of Madhya Pradesh, from pharma company, Unichem. This newly established manufacturing facility makes Finished Dosage Forms (FDFs). In its order dated June 6, the CCI said that the combination is not likely to have an appreciable adverse effect on competition in India and therefore, the commission hereby approves the combination. It observed that, the proposed acquisition by Mylan was with intent to export products to be manufactured at the said facility. Further, the regulator noted that the deal would not affect any market in India as, “Mylan is neither acquiring any shares, voting rights or control in Unichem, nor any brands or intellectual property rights from Unichem.” According to the details stated in the order, Mylan has 11 manufacturing facilities in India, of which 8 facilities, manufacture Active Pharmaceutical Ingredients (API) and two facilities manufacture FDFs. Unichem is said to have 7 manufacturing facilities in India, of which 2 facilities are into manufacturing of APIs, and 5 for FDFs, which form the core of its business.


0RGHUQ3KDUPD‡ -XQH

News, Views & Analysis

AstraZeneca to take over Pearl Therapeutics to build respiratory portfolio AstraZeneca has voiced plans to take over Californiabased Pearl Therapeutics, by entering into a definitive agreement. Following the deal, the company will focus on the development of its inhaled small-molecule therapeutics for respiratory disease. This acquisition will offer AstraZeneca, access to a potential new treatment for Chronic Obstructive Pulmonary Disease (COPD), currently in late-stages of development, inhaler and formulation technology that will provide a platform for future combination products. As per the terms of the agreement, AstraZeneca will acquire 100 per cent of Pearl’s shares for initial consideration of $ 560 million payable

on completion. In addition, deferred consideration of up to $ 450 million becomes payable, if specified development and regulatory milestones in respect of any triple combination therapies and selected future products that AstraZeneca develops using Pearl’s technology platform are achieved. Sales-related payments of upto $ 140 million are payable, if pre-agreed cumulative sales thresholds are exceeded, resulting in a total potential acquisition cost of up to $ 1.15 billion. The proposed transaction is subject to customary regulatory approvals and is expected to close in the third quarter of 2013. Speaking on the development, Pascal Soriot,

Abott begins randomised clinical trials in Japan to assess Absorb™ BVS Abbott has initiated the Absorb™ Japan randomised controlled clinical trial. The trials are conducted to evaluate the Absorb™ Bioresorbable Vascular Scaffold (BVS) in patients with Coronary Artery Disease (CAD), the most common form of heart disease. The study will focus on the innovative ‘Dissolving’ heart device compared to company’s marketleading drug-eluting stents in patients with CAD in Japan. The results of this trial will support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb™ BVS in Japan. Absorb™Japan will enroll approximately 400 patients and compare the performance of Absorb™to Abbott’s market-leading XIENCE™ family of metallic drugeluting stents. The primary endpoint is Target Lesion Failure (TLF) at one year, a combined measure of safety and efficacy of the device. Takeshi Kimura, M D and professor in the department of cardiovascular medicine, Kyoto University Hospital, is the principal investigator of the Absorb™ Japan trial. “Unlike permanent metallic stents, Absorb™ dissolves over time, which may allow the blood vessel to regain natural function, a unique effect that could have significant impact on the way, coronary artery diseases are treated in Japan,” said Prof Kimura. “While the clinical outcomes of Absorb™ have been demonstrated in international clinical trials, we now have the opportunity to understand the impact of this technology in Japanese patients in a comparative study. We hope the results of this effort support the process to make Absorb™ widely available for clinical use in Japan in the future.” The trial will also incorporate stateof-the-art imaging techniques to study the impact of treatment with Absorb™ in the blood vessel. Ongoing evaluation will continue in randomised trials, such as Absorb™ Japan, to understand the unique, long-term benefits of a device that dissolves completely over time.

CEO, AstraZeneca, said, “Chronic obstructive pulmonary disease continues to increase worldwide and there is a growing need for the next generation of inhaled combination products. Pearl’s novel formulation technology, together with its development products and specialist expertise are a great complement to AstraZeneca’s long-established capabilities in respiratory disease, one of our core therapy areas. Combined with our on-market portfolio, including Symbicort, and our strong pipeline, the agreement will enable us to offer further distinctive treatment options across the full spectrum of COPD and asthma to patients, physicians and payers.”

Dr Reddy’s selects Polycom® RealPresence® video collaboration solutions to accelerate drug development Dr Reddy’s Laboratories Ltd, has selected Polycom® immersive video collaboration solutions including the Polycom® RealPresence® Experience (RPX),to enable executives and employees across two major corporate offices in Hyderabad, India, and Bridgewater, New Jersey, USA to collaborate face-to-face via secure, highdefinition video. “Our company’s global demand for instant communication across distances, particularly between R&D teams to make decisions quickly, meant that we required more effective and efficient ways to collaborate. With Polycom video, we are getting the most comprehensive UC infrastructure that meets our needs to deliver wide-scale communications across the company, enabling our research and technical teams to meet across any distance and collaborate securely and instantly for vital consultation and decision-making,” said Atanu Roy, Chief Technical Officer, Dr Reddy’s.

Dr Reddy’s has deployed several Polycom solutions to improve its business processes. This includes two Polycom RPX™ immersive telepresence solutions in its Hyderabad and Bridgewater, New Jersey corporate centres, fitted with document cameras to display samples of drugs and generics for real-time inspections with FDA officials, product reviews with co-workers, and sample showcases for buyers. The company will also look into implementing additional immersive, room, and mobile video solutions across more locations to continue the transformation in team collaborations and create a new video work culture. Further, the company also plans to introduce video collaboration at manufacturing facilities, to enable R&D teams to liaise more quickly and efficiently in formulating new drugs and generics, and obtaining approvals from authorities.

9


10

0RGHUQ3KDUPD‡ -XQH

News, Views & Analysis

Boehringer Ingelheim inks agreement with Zhangjiang Biotech Boehringer Ingelheim has inked a strategic business alliance with Zhangjiang Biotech & Pharmaceutical Base Development Company to build a Current Good Manufacturing Practice (cGMP) biopharmaceuticals facility. This new biopharmaceuticals facility will provide full range of development and clinical services to Chinese and multinational customers. It will become the first facility to be established by a leading international biopharmaceutical manufacturer in China, utilising mammalian cell culture technology. The facility set up will include technical process development and cGMP manufacturing, which will be ready for operation by early 2016. Boehringer Ingelheim plans an investment of over € 35 million. The project will create up to 65 job opportunities with high qualification standards. “Our partnership with ZJ Base Company is an important step in our global China strategy as it opens a further opportunity for Boehringer

Ingelheim to participate in the growing demand for high quality biopharmaceuticals in China,” stated Christian Boehringer, Chairman of the shareholders committee, Boehringer Ingelheim. Lanzhong Wang, General Manager, ZJ Base Company commented, “We are very pleased to start the partnership with a leading biopharmaceutical company like Boehringer Ingelheim. Through the cooperation, we hope to bring here the know-how, technology and experience, all upto international standards. With a number of innovative medicines being developed by a cluster of middle to small-sized innovative companies in Zhangjiang, plus the government support, we plan to initiate the Contract Manufacturing Organisation (CMO) framework at this plant on a trial basis. This will provide an effective platform for middle and small-sized companies to industrialise their innovations. Thus, it will greatly prompt the development of China’s biopharmaceutical manufacturing industry.”

Fresenius takes Dr Reddy’s to court for infringement on patented anaesthetic, Diprivan US-based drug-maker, Fresenius Kabi has taken leading pharmaceuticals company, Dr Reddy’s Laboratories (DRL) to court for allegedly infringing on the former’s patented injected anaesthetic, Diprivan on four counts. The inventors had assigned four patents to Zeneca in 1998 and subsequently they assigned them to APP Pharmaceuticals LLC, which later changed its name to Fresenius Kabi USA,

LLC. Accordingly, Fresenius is the owner of all rights, title and interest in the patent. In 1999, Zeneca and the Sweden-based pharmaceutical company, AstraAB merged to form AstraZeneca plc. The petition said that, DRL filed an Abbreviated New Drug Application (ANDA) with the US regulator seeking approval to manufacture, use, and offer for sale, sell in and import into the US, a Propofol injectable, even before the expiration of the patent.

The US drug-maker requested the court to pass an order refraining DRL and all persons acting in concert with defendants from commercially manufacturing, using, offering for sale, selling, marketing, distributing, or importing DRL’s generic Diprivan product, or any other product or compound the use of which infringes the patents, or inducing or contributing to the infringement of the patents until after the expiration of the four patents.

In Brief Scientists honoured for best research paper in pharmaceutical analysis The 8th Dr P D Sethi’s Annual Award for the best research paper published in the field of pharmaceutical analysis for the year 2012 was jointly awarded to Dr Wahajuddin, Sheelendra Pratap Singh, K S R Raju, Asad Nafis and Girish Kumar Jain from Pharmacokinetics and Metabolism Division, DSIRCentral Drug Research Institute, Lucknow. The award was instituted by KONGPOSH publication, publishers of The Pharma Review and Indian Pharma Reference Guide in honour of Dr P D Sethi, an eminent pharma analyst. The scientists were honoured for their paper titled, ‘Simultaneous determination of nine model compounds in permeability samples using RP-HPLC: Application to prove the cassette administration principle in single pass intestinal perfusion study in Rats Journal of Pharmaceutical and Biomedical Analysis 67-68 (2012) 71-76.’ They have been rewarded a cash prize of ` 10,000 and a certificate. 149 papers from different institutions competed for this award.

Sun Pharma receives USFDA approval for generic Depo®-Testosterone injection Sun Pharmaceutical Industries Ltd has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for generic version of Depo®-Testosterone injection, testosterone cypionate injection USP, 100 mg/ml and 200mg/ml. This generic testosterone cypionate injection USP, 100 mg/ml and 200mg/ml is therapeutically equivalent to Depo®-Testosterone injection of Pfizer Inc. It is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

Pfizer receives $ 2.15 billion from Teva and Sun for infringement of Protonix® patent Pfizer Inc, received $ 2.15 billion settlement from Teva Pharmaceutical Industries Ltd and Sun Pharmaceutical Industries Ltd for patent-infringement damages resulting from their ‘at-risk’ launches of generic Protonix® in the US. Under the terms of the settlement, Teva and Sun will pay a total of $ 2.15 billion to compensate Pfizer’s subsidiary Wyeth and Takeda for the damages they suffered when Teva and Sun launched ‘at-risk’ generic versions of Protonix. Teva will pay Pfizer and Takeda $ 1.6 billion and Sun will pay $ 550 million. Teva will pay $ 800 million in 2013 and the remaining $ 800 million by October 2014; Sun’s entire payment will be made in 2013. Both Teva and Sun have admitted that their sales of generic pantoprazole infringed the patent that was held valid by the court.


0RGHUQ3KDUPD‡ -XQH

News, Views & Analysis

11

New laboratory balance for weighing reliability in regulated areas The new Secura laboratory balance developed by Sartorius for applications in regulated areas such as pharmaceutical labs fulfills particularly high reliability requirements. The balance monitors its ambient conditions a u t o m at ically , t h er eby preventing handling errors. This increases the reliability of weighing procedures in pharmaceutical labs and helps users to achieve even better measurement results. Nine different models of the Secura balance are available, covering a range of weighing capacities from 120 gm to 5,100 gm, and a readability of 0.1 to 10 milligram. The balance is also equipped with various assistance systems designed to prevent further processing of uncertain weighing results, which frequently occur

through operating errors during weighing. If errors occur, the balance identifies the uncertain weighing results in the display and blocks their transmission. Secura can therefore increase process reliability and decrease error rates in the lab. The LevelControl system ensures precise leveling of a balance, which is an essential component of equipment monitoring and a prerequisite for obtaining accurate readings. The electronic LevelControl sensor ensures that Secura is perfectly level. Non-compliance is indicated visually in the display and blocks output of the reading. Clear instructions in the display guide the user through the leveling procedure simply and safely. This means that lab staff can easily level Secura laboratory balances

DHL event deliberates key supply chain issues in the pharmaceutical sector DHL Supply Chain recently concluded a successful customer event, ‘Unlocking Supply Chain in Healthcare and Life Science Logistics’ in Mumbai. The event deliberated on relevant topics related to challenges and opportunities in the overall supply chain in the pharmaceutical industry. These included distribution and channel management, benefits of collaborated and integrated supply chain, current regulatory issues facing the life sciences and healthcare sector, along with new insights and opportunities for clinical research in India. Prakash Rochlani, Vice President - Business Development, South and South East Asia, DHL Supply Chain said, “Targeting the life sciences and healthcare industry, this event provided an ideal opportunity for collaboration, discussion and networking between sector experts and the pharmaceutical industry. To stay ahead in today’s dynamic environment it is paramount to understand the industry’s issues and challenges, skillfully adapt and respond with increasing flexibility to changes and embrace new trends.” Speaker presentations at the event highlighted the expected growth in the Indian pharmaceutical industry at 1.5 to 2 times the GDP growth of India. This is due to several factors that include increased literacy, higher per capita income, improved healthcare access and greater market penetration. It was estimated that the distribution and channel management initiatives can improve sales by at least 4 - 5 per cent per annum, thereby extending the lifecycle of a product. With distribution being highly unorganised in India and its complexity increasing over the years, especially in Tier-2 cities, it was felt that supply chain managers have an excellent opportunity to penetrate the market and increase distribution efficiencies through smart logistics.

located in safety work benches or safety weighing cabinets without having to open the safe work area. Even minor temperature fluctuations in the lab have a considerable influence on the reproducibility of weighing results. For this reason, balances have to be calibrated regularly and as soon as the ambient conditions change. Once a specified time or temperature threshold is reached, Secura’s calibration and adjustment function, isoCAL, informs the user and automatically adjusts the balance using internal weights. Every adjustment is documented and can be traced for quality assurance purposes. Every balance used in regulated areas such as pharmaceutical labs has to meet the requirements specified by the FDA.

Pharmaceutical labs therefore have to determine the minimum sample weight according to the USP (United States Pharmacopeia) on site, and measurements may not fall below this limit. On request, Sartorius service staff will determine this value during first operation of the Secura balance and issue a minimum sample weight certificate.

The user interface of the Secura balance has been developed in collaboration with experienced users. The weighing applications are represented as clearly understandable icons on the touchscreen of the Secura balance. This allows users to launch any of the balance’s programs with the touch of a finger, without first having to read the operating manual. Secura only displays the information required for the particular operation. The colour-coded information and action fields make operating errors almost impossible. Settings that could change data output or the metrological performance of Secura can be password-protected so that access to them is restricted to authorised persons only.


12

0RGHUQ3KDUPD‡ -XQH

In Conversation With

India will be the knowledge centre of the world for scientific and clinical research of medicinal, herbal and nutraceutical products …says Dr Sharad Kasarle, Chief Scientist, DSK Nutrition Research Center Pvt Ltd After being associated with world-class organisations such as Marico Industries Ltd, Kelloggs India, Hindustan Unilever Ltd, Corn Products Co India Ltd, Tasty Bite Eatables Ltd, Nestle and Alkem Laboratories to name a few, he moved on to start his own company. Dr Kasarle is now associated with the National Institute of Nutrition. In this succinct conversation, Dr Kasarle sheds light on the recent advancements in the nutraceutical sector.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

What got you interested in nutraceuticals? Being a food scientist and technologist, nutraceuticals have always been close to my heart. I firmly believe that wellness will be the next biggest opportunity, gauging its market size. In fact, exponential growth of nutraceuticals world-wide, clearly indicates the possibility of its dominance in the immediate future. What is the recently invented natural medicinal product developed by you to cure diabetes? It is a scientific herbal nutrition for diabetics that act as insulin for patients suffering from hyperglycaemia. It is an oral administration that helps blood sugar control and also helps maintain blood cholesterol levels naturally. Tell us about the new specialised nutrition, DSK plans to introduce in the market. The specialised nutrition product that DSK plans to introduce in the market is: Nutritionally modified sugar for diabetics and the weight conscious This specialised nutritionally modified sugar tastes as natural and sweet as sugar, without any bitterness or lingering sweetness on the taste buds. The sugar needs to be used in the same quantity as a normal sugar and can be used in variety of foods. It is 100 per cent pure and natural. It does not require any bulking agent, has lower glycemic index and glycemic load, thereby qualifying itself as a perfect medical nutrition sweetener for diabetics, the calorie and weight conscious. Further, this specialised nutrition contains prebiotic fibres for healthy maintenance of intestinal micro flora and immunity. This natural sweetener is ideal for all ages, and can be safely consumed by pregnant, lactating and nursing women. The other diabetic medical nutrition product contains authentic nutraceuticals, micronutrients and herbal derivatives for healthy blood glucose, blood cholesterol and fat management. This is a natural product devoid of any side effects and toxic elements.

Describe in brief DSK’s focus on R&D DSK Nutrition Research Center is inspired by dedication & passion. It is backed up with strong support from scientific research, power of technology and wealth of nature. The nutrition research center is constantly involved in development of innovative and specialised nutrition therapies with great sensory attributes for consumers

Specialty Medical Nutrition and Nutraceuticals Obesity nutrition for weight management Cardio nutrition for healthy management of cholesterol and triglycerides Cardio nutrition for improving healthy circulation and maintain health of cardiac muscles Diabetes nutrition for healthy blood glucose and HbA1C management. Cancer nutrition Immunity enhancement through medical nutrition Treating chronic constipation and colon cleansing through Herbaceuticals Neurodegenerative disorders like depression, anxiety, loss of memory and concentration. Neuropathy through nutraceuticals Insomnia and sleep apnea management through medico nutritionals Paediatric nutrition Nutrition for new born, infants, pregnant lactating and nursing mothers More than 150 formulations in medical nutrition and functional foods have been researched and developed.

of all ages. The nutraceuticals will help prevent the occurrence of conditions resulting from lifestyle disorders such as obesity, diabetes, stress, heart and brain health, bone and joint health, immunity, etc .It is all about appropriate and adequate clinical nutrition, while replenishing the nutritional deficiencies through consumption of tasty food product formulations. Breifly describe the current working of FSSAI The Food Safety and Standards Authority of India (FSSAI) established under Food

Safety and Standards (FSS) Act, 2006, consolidates various acts and orders that have been created for laying down sciencebased standards for articles of food and to regulate their manufacture, storage, distribution, sale and import. It further ensures availability of safe and wholesome food for human consumption. FSSAI has been mandated by the FSS Act, 2006 for performing functions such as laying down mechanisms and guidelines for accreditation of certification bodies. The accreditation bodies are engaged in the certification of food safety management system for food businesses, procedures and guidelines for accreditation of laboratories and notification of the accredited laboratories, providing scientific advice and technical support to Central Government and State Government in matters of framing policies and rules in areas which have a direct or indirect bearing of food safety and nutrition. It also collects and collates data regarding food consumption, incidence and prevalence of biological risk, contaminants in food, and residues of various contaminants in food products, identification of emerging risks and introduction of rapid alert system.These efforts are complemented by creating an information network across the country such that the public, consumers, panchayats etc receive rapid, reliable and objective information about food safety and issues of concern. They also provide training programmes for persons, who are involved or intend to foray into food businesses, contribute to the development of international technical standards for food, sanitary and phytosanitary standards and promote general awareness about food safety and food standards. What positive changes have been brought about by FSSAI? It has become difficult for pharmaceutical companies to promote nutritional supplements and health foods, either through prescription (where they have to justify the medical claims to doctors) or OTC/FMCG route, wherein claims are advertised through the electronic media, as FSSAI has stopped allowing direct health claims that are not backed by authentic clinical or scientific research. Without claims, marketing of these products are hampered. Also, the right concentration of nutritional ingredients for health benefits is mandatory to allow some claims, which may increase the cost of the product. FSSAI is continuously gearing to educate

the consumers from faulty and misleading advertisements, claims etc. through various campaigns and making it compulsory to declare the nutrition facts, such that consumers are aware of the product quality and health benefits. Is India ready to export nutraceuticals to Europe? Please provide more details on the quality control measures that need to be undertaken to strengthen exports. India will be known as the knowledge centre of the world for scientific and clinical research of medicinal, herbal and nutraceutical products. These products will be of global importance as, most of these herbals are grown in India and the cost of research operations in India will be cost-effective. India will enjoy monopoly over the world, in terms of active constituents of the medicinal herbs, their overall quality, freshness and the quantum of production. Herbs such as Curcumin (extract from turmeric) are used in the management of cardiovascular diseases, cancer and arthritis, Lycopene (extract from tomatoes), Capsaicin (extract from chillies), and beta carotene from carrots, green tea, Ashwagandha (Indian Ginseng), Shatavari and Stevia would be of more value to the Indian economy in the near future. What were the changes witnessed by the nutraceutical sector over the last 25 years? Food industry is gradually transforming into health foods. While the pharma industry is diversifying aggressively into nutraceuticals, which in itself is the biggest proof and success indicator for the neutraceutical sector in the near future. Fortifying junk foods with nutraceuticals and functional food ingredients, the biscuits and cookies today comprise of dietary fibres and supplements, bread with multi-grain and fibres, low-fat cheese and butter spreads, roasted instead of being fried, antioxidants in edible oils, low sodium salt, sugar substitutes and sugar free foods. How do you envision the neutraceutical sector in India by 2020? Nutraceuticals and functional foods will dominate globally followed by herbal medicines and health care products by 2020. Health issues like diabetes, cardio, stroke and neurological disorders can be best managed by nutraceuticals. It will not be less than trillion dollar industry.


0RGHUQ3KDUPD‡ -XQH

Special Focus

13

Generic injectables

On a growth trajectory For drugs that are poorly absorbed orally, or when a patient is unconscious, injection is the first choice. Being most common of the parenteral route, the production of generic injectables requires special attention. Here, we explore the current market trends and steps being taken towards ensuring better quality of injectables.

Hardik Ashar pallavi.mukhopadhyay@network18publishing.com

very patient requires the most effective treatment in the shortest possible time and long-term therapy is sometimes not acceptable. In case of hospitalised patients, elderly and neonates,the parenteral route is the choice for drug administration; eg Paracetamol IV infusion for fever. The double-digit growth of the parenteral drug delivery sector is primarily due to intelligent product lifecycle management by pharmaceutical companies along with novel technological advancements, swelling rise in usage of biologics and biosimilars in pharmaceutical markets, rising incidences of cancer, diabetes and introduction of newer vaccination programme at global level. These factors work together towards accomplishing a single goal of improving patient compliance.

E

have acquired the technical expertise, manufacturing capabilities and International accreditation in this niche segment. “India is gradually becoming a major cost competitive player in the global parenteral drug landscape. The above fact is a compelling factor contributing to the recent trend of acquisitions seen in local parenteralmanufacturing industry. Acquisition and merger deals in the injectable space have been driven by objectives of capacity expansion, cost optimisation and technology acquisition, along with the growing interest of international companies to acquire or collaborate with Indian companies,” says Jain. “In India as well, the injectable market showcased significant growth with tremendous potential, yet to explore. According to research study conducted by a consultancy firm, the domestic

Global market trends The global injectable drug delivery technology market was valued at $ 22.5 billion in 2012, and is expected to reach $ 43.3 billion by 2017 at a CAGR of 14 per cent from 2012 to 2017. North America accounted for the largest market share of 41.3 per cent of the global injectable drug delivery technologies market, followed by Europe (30.2 per cent) in 2012. “Sterile injectable as a segment continues to grow in importance. It is a significant driver of the top line and profits of most of the pharmaceutical manufacturers,” suggests Sanjeev Jain, Director, Akums Drugs & Pharmaceuticals Ltd. “A fast developing segment within parenterals is of biologics where, monoclonal antibodies and bioengineered vaccine injectables are expected to grow faster than the average market pace,” avers A K Sahoo, CEO, Ozone Pharmaceuticals Ltd.

Trends in India There are quite a few Indian pharmaceutical players present in parenterals, who

A fast developing segment within parenterals is of biologics where, monoclonal antibodies and bioengineered vaccine injectables are expected to grow faster than the average market pace. A K Sahoo CEO, Ozone Pharmaceutical Ltd

injectable antibiotics market is worth $ 425 million and has been growing at a CAGR of 21 per cent in the last three years,” says Sahoo.

the frequency of injection. Adaptability towards controlled parenteral drug delivery is on the rise. Advancements in pharmaceutical technologies are serving the needs of patients, undergoing chronic therapies like insulin in diabetes or who are hospitalised. The new technologies such as oil in water emulsion, microspheres, liposomes, microemulsion, suspension etc, are entering global markets with new possibilities for better efficacy and safety, as well as patient compliance. Another sector technologically advancing is that of auto-injections. Most autoinjectors are spring-loaded syringes. By design, they are easy to use and are intended for selfadministration by patients. The site of the injection depends on the drug loaded, but it typically is administered into the thigh or the buttocks. Injectors were initially designed to overcome the hesitation associated with self-administration of the needle-based drug delivery device. Needle is automatically protected after injection. The autoinjectors are designed for patient safety, easy to handle and use, ergonomic in design, disposable and provide confirmation for increased confidence.

New avenues Parenteral controlled release formulations are primarily the achievement of a relatively constant and substantially sustained therapeutic drug level with a reduction in

Quality check With ever-increasing vigilance by the USFDA, quality has been on an increased focus. There are increasing number of cases of non-compliances brought into

knowledge. However, reacting to such non-compliances, Indian companies have raised indigenous surveillance to match upto the high quality standards and avoid noncompliances at all costs.

Sterile injectable as a segment continues to grow in importance. It is a significant driver of the top line and profits of most of the pharmaceutical manufacturers. Sanjeev Jain Director, Akums Drugs & Pharmaceuticals Ltd

“To improve the quality training of workers and technical personnel for injectable manufacturing is the top most priority. Separate aseptic manufacturing area is required to be maintained by pharmaceutical companies in general plants,” says Jain. Today, the trend of deployment of dedicated injectable plants complying with WHO-GMP

standards is being established to improve quality. Blow fill seal technology is used in many production units to check the sterility and microbial contamination issues. Installation of HEPA filter is a must-have in every injectable facility, to check the airborne contamination. Cleaning validation and Standard Operating Procedures (SOPs) are maintained, along with sanitisation at shop floor to reduce cross contamination. Technological and regulatory advancements are springing up faster and it is becoming increasingly difficult for industries to catch up with this pace and adopt them. However, aseptic processing demands the highest standards of quality in parenterals manufacturing. But the market does not pay appropriate price for quality and the Return on Investments (RoI) on technology is becoming unviable for most pharma companies, especially in Europe and Brazil. In price-sensitive markets, even government fails to analyse the price in tenders versus cost of quality. There may be shortcut to quality and hence the cost of goods manufactured with 100 per cent quality compliance, can sometimes be on the higher side. “Despite the market growth, industry is still facing a number of other challenges such as secure funding for new technologies and slower regulatory processing. This in turn escalates the cost of New Chemical Entity (NCE) development to more than $ 800 million,” informs Sahoo.


14

0RGHUQ3KDUPD‡ -XQH

Special Focus

Novel drug delivery systems

New target therapies in injectables Novel Drug Delivery Systems (NDDS) have always remained at the forefront of innovation for targeting new diseases, as well as to improve the existing medication regime and patient’s experience. Researchers continue to explore advanced techniques to design novel systems for drug delivery.

nikunj.kumar@network18publishing.com

raditionally, drugs are administered orally or through injection, which does cause inconvenience and side effects. Novel Drug Delivery Systems (NDDS) are designed to administer drug dosage more effectively and efficiently, by offering controlled release of drug delivery at a specific rate and targeted site. NDDS reduces the drug amount, increases target specificity, minimises side effects and enhances patient convenience in comparison to oral drugs or injectables. According to a research paper by R R Bhagwat and I S Vaidhya [Novel Drug Delivery Systems: An Overview in International Journal of Pharmaceutical Sciences and Research 2013; 4(3); 970982], the global market for advanced drug delivery systems is projected to reach $ 196.4 billion in 2014, exhibiting a Compounded Annual Growth Rate (CAGR) of 7.2 per cent from 2009 to 2014. The market is largely governed by targeted drug delivery segment, which accounted for $ 50.9 billion in 2009 and is forecast to grow to $ 80.2 billion by 2014, at a CAGR of 9.5 per cent. Next category is the sustainedrelease products with about $ 36.1 billion sales revenue in 2009 and projected to reach $ 5.8 billion through 2014, registering a CAGR of 4.9 per cent. Dr Monica Gulati, Senior Dean, Lovely Faculty of Applied Sciences, Lovely Professional University says, “Targeted drug delivery systems hold enormous potential to change the face of 21st century clinical practice, but despite continued efforts during the last four decades it has been able to achieve limited success. A number of attempts at developing ‘smart systems’ have been made with the aim of prolonged duration of activity, decrease in adverse effects, increased patient compliance and quality of life.” Dr Gulati further adds, “Most of these drug delivery systems are based either on a change in formulation (eg, nanoemulsions, liposomes) or an addition to the drug molecule (eg, PEgylation).

T

*Classification of NDDS Carrier-based drug delivery system Liposomes Nanoparticles Microspheres Monoclonal antibodies Niosomes Resealed erythrocytes as drug carriers Transdermal drug delivery system Sonophoresis Mucoadhesive delivery systems Supramolecular delivery systems Variable release delivery systems Osmotic pump Microencapsulation

NDDS in herbal remedies For use of NDDS in herbal remedies, the novel carriers are required to comply with two prerequisites. First, it should deliver the drug at a rate directed by the bodily needs, over the period of treatment. Second, it should channel the active entity of herbal drug to the site of action. *Source: R R Bhagwat and I S Vaidhya [Novel Drug Delivery Systems: An Overview in International Journal of Pharmaceutical Sciences and Research 2013; 4(3); 970-982]

In the Indian context, where a sizable population finds medical care unaffordable, there is a need to develop novel therapies of drug delivery in a cost-effective manner. Dr Monica Gulati Senior Dean, Lovely Faculty of Applied Sciences, Lovely Professional University

Recent advances In 2013, Ethypharm, a major developer of Drug Delivery Systems (DDS) for targeted therapies with a product portfolio of over 50 products marketed in more than 70 countries, completed the phase-IIIstudy to access the clinical efficacy and safety of Fentanyl ETHYPHARM for Breakthrough Pain (BTP) in opioid-treated patients with cancer. According to a recent study published in The Scientific World Journal Volume, several attempts have been made to devise new drug delivery systems for Intraperitoneal (IP) chemotherapy by using microparticles, liposomes, nanoparticles, micelles, injectable depots and implants for IP delivery. Inadequate drug delivery to solid tumours is the main reason behind failure of IP treatment. Hence, many drug delivery strategies have been investigated to increase the residence time of the chemotherapeutic agent as well as optimise IP therapy. Another report from Science Daily suggests that research work published in ‘Journal of Materials Chemistry B’ by a team of scientists led by Dr Katsuhiko Ariga, claims to develop a gel material for new method of drug administration. This releases drug on applying pressure manually. The gel incorporates cross-linked natural polymers comprising calcium alginate, an algal extract, and cyclodextrin, a saccharide, which hosts the drug. The concept is first-ofits-kind so far that, involves a host-guest interaction managed by mechanical stimulus. The efficacy of the antiemetic drug ‘Ondansetron’ contained in the gel was found to last for three days, on application of stimulus mimicking fingerpressure. “While critically looking at the clinical data available in the literature, we have realised two features that we can claim to have achieved for these ‘smart’ delivery systems. These are reduction in adverse reactions and better delivery to target site. The ‘smart’ drug delivery systems have been able to prevent certain adverse effects, both during infusion ie, Abraxane, which prevents local inflammatory reactions during paclitaxel administration), and during circulation ie, Doxil reduces doxorubicin-induced cardiomyopathy. Both these

Conceptual scheme of controlled release of ODN from a hydrogel composed of a CyD-containing molecular network by mechanical compression. systems have proved to be clinically very successful because of improved patient compliance,” Dr Gulati states.

AllStar™: The made-inIndia reusable insulin pen A good example of NDDS is the AllStar™, recently launched by Sanofi, which was its first indigenously manufactured reusable insulin pen. The company developed this solution for Indian market especially, and is indicated for use of insulinised patients using Sanofi’s insulin portfolio. AllStar™ is custom-made for patients in India. It will help improve both insulin initiation and compliance, while offering convenience of international standards at an affordable price. Drug providers need to continuously evolve on new and convenient mechanisms of drug delivery to help patients manage diseases in a better way. Emphasising on the local needs Dr Gulati avers, “In the Indian context, where a sizable population finds medical care unaffordable, there is a need to develop novel therapies of drug delivery in a costeffective manner. Taking cue from the earlier success stories, scientists at the School of Pharmaceutical sciences, Lovely Professional University are engaged consistently in development of rational, cost-effective solutions to address the existing gaps in clinical therapies.” “A combination of two simple approaches to overcome the side effects associated with the therapy of colon cancer has been filed as a patent in more than 140 countries. This has further successfully entered the national phase

in 38 countries of European Union, USA, China and Japan. Unless and until, a pragmatic approach is adopted, NDDS will continue to be a science fiction. We should therefore, try to come up with straightforward formulations that can be easily translated into clinically useful products, to make drug delivery systems a ‘smart’ part of clinical reality,” Dr Gulati informs.

What’s next: HDDS? The NDDS has definitely unearthed the alternative routes to drug delivery by targeting new areas of diseases using this concept. After NDDS, what can be further explored to make drug delivery more convenient and effective? A very recent research paper by *Mohamed Saifulla P, College of Pharmacy, JSS University, Mysore presented a model of Hybrid Drug Delivery (HDD) targeting candidiasis and cancer.

HDDS A Hybrid Drug Delivery System (HDDS) refers to an exclusive dosage form, in which the same mucoadhesive tablets can be delivered via multiple routes, either through oral/vaginal route for candidiasis and oral/ vaginal/rectal route for cancer therapy. The effectiveness of the specialised drug delivery systems has been enhanced with the use of different combination of polymers in the form of Interpolyelectrolyte Complex (IPEC). The paper also suggests that such type of HDDS can be designed for those drugs, which are intended to deliver through oral,vaginal,or rectal route. *Source: http://hdl.handle. net/10603/9141

Source: National Institute for Materials Science

Nikunj Sharma

Injectable continuous-release systems deliver drugs in a controlled, pre-designed manner and are able to avoid large fluctuations in plasma drug concentrations.”


0RGHUQ3KDUPD‡ -XQH

Special Focus: Interface

15

Industry standards have improved signiďŹ cantly over the past decade in terms of quality awareness Hardik Ashar pallavi.mukhopadhyay@network18publishing.com

What are the recent trends driving the small volume and other parenteral delivery systems for double-digit growth? Over the last five decades, there have been considerable technological advances in the area of parenteral drug delivery and it is important to overcome the limitations imposed. There are many factors contributing towards exponential growth of the parenteral drug delivery system, which are: Broadening of therapeutic areas Development of target-based therapies, vaccines for highly fatal diseases, innovations in new delivery mechanisms and development of innovative immunotherapeutics, address key issues of highly unmet clinical needs are the major key research focus areas. We at, Venus Medicine Research Center (VMRC) are primarily focused on antimicrobial resistance and targeted delivery for cancer therapy and detection. Innovation from research-based organisations Innovations are oriented towards unmet medical needs in the area of specialisation of a specific company. There are many research and development activities on Novel Drug Delivery Mechanisms being carried out such as autoinjectors, needle-free injectors and nasal spray devices while, formulation-based technologies range from liposomes and emulsions, PEGylation, micro/ nanoparticles and dendrimers, either used alone or in combination to optimise delivery and minimise off-target toxicities. How have the research based activities contributed towards growth of the parenteral product segment? Our contribution to innovations have been significant with 85 patents granted from across the world on development of Antibiotic Adjuvant Entity (AAE) used for the treatment of infections caused by Multi-drug resistant bacteria often termed as superbugs. The patents registered and novel drug delivery mechanisms have jointly propelled growth in the parenteral product segment to register close to 15 per cent, over the last five years. Furthermore, the booming vaccine market which is growing at more than 20 per cent in the last five years, presents ample opportunities for growth and this will support the growth of antibiotic and anticancer injectables market. The antibiotic and anticancer injectables market represents the biggest segment, which is currently outpacing the average parenteral growth. How are patients benefitting from controlled parenteral drug delivery approaches? Sustained-release injectables are popular among patients who suffer

chronic illnesses. Injectable products that offer controlled drug release reduce the frequency of injections, which increases patients compliance. Sustained-release injectables also offer therapeutic advantages and enhance the quality of patients’ lives. Demand for these medicines is increasing, and is a vast field to work on. VMRC has developed for the first time, a pain relieving injection which offers controlled release and gives instant relief from acute pain. The release is later controlled for 24 hours. The sustained-release injectables are available, as once daily injection. This acts as a boon for patients with chronic pain. What are the measures undertaken to strengthen the quality of parenteral products? Industry standards have improved significantly over the past decade in terms of quality awareness and compliance worldwide, especially in

...avers Ashutosh Jain, COO, Venus Pharma GmbH. In this freewheeling conversation, he talks about the recent trends, adaptability of new approaches and quality measures to be adopted for parenteral products. India. With regulatory norms becoming more stringent, the process of marketing authorisation is becoming difficult and prolonged. More emphasis is laid on validation of each stage of the process, analytical validations with impurity profiling during stability studies, validation of all machines, water system and HVAC, besides performing annual product quality reviews, trainings of team members, risk analysis and

Corrective and Preventive Actions (CAPA) are the key measures taken to strengthen quality of parenteral products.


16

0RGHUQ3KDUPD‡ -XQH

Special Focus: Roundtable

Are strict regulatory compliances responsible for supply shortage and manufacturers’ withdrawal from injectables? Nikunj Sharma nikunj.kumar@network18publishing.com

Kannan Ragunathan

K V Subramaniam

Director, Sathguru Management Consultants Every governmental regulation has benefits and cost. The same implies to Food and Drug Administration (FDA) regulations as well. Drug regulators ensure that harmful drugs do not reach consumer hands, while also holding responsibility for the cost of delays. At times, they do prevent beneficial and much needed drugs from reaching consumers as well. Several studies in the past have quantified Type I errors (FDA allowing harmful drugs) and Type II errors (FDA disallowing beneficial drugs) and the results indicate that the harm caused from Type II errors, far exceeds those from Type I errors. The beginning of 2010 experienced sudden spike in shortage of generic injectables due to FDA’s intensified inspection and compliance efforts. This made four of America’s largest manufacturers of generic injectable products to cut down on their production volume FDA’s strict regulatory norms on and even temporarily suspend some of injectables and frequent inspection their production facilities. drive has forced manufacturers to The FDA desired that, all injectable manufacturers take necessitated action reconsider injectables production. Will promptly, thus resulting in shortage of the drive cause shortage for much needed injectables in the market. drugs to consumers or further strengthen Drug companies receive strong incentives to maintain quality from an the drug supply value chain? Our experts ongoing quality concern perspective. Else analyse the various aspects of it and they run the risk of being out of business opine on the issue. due to regulatory penalties like import alerts, fines imposed, product recalls or close of manufacturing facilities. The question then arises, if there is over regulation such as, to an extent of not striking balance between benefits of continuous remediation efforts of FDA inspection observations versus creating shortage of medicines to consumers. Maybe, a balanced approach by FDA could have avoided some of the injectable drug shortages.

President and CEO, Reliance Life Sciences Over the last couple of years, vast product shortages were reported in the US and most of them were related to the sterile injectable drugs. There were many reasons for these shortages, which included – quality/manufacturing issues, discontinuation of products by manufacturers, limited number of Active Pharmaceutical Ingredients (API) suppliers for older injectable drugs and small number of manufacturers with limited production capacities. However, the situation has improved considerably this year, with many manufacturers regaining FDA approvals for their facilities and thus, resuming supplies of injectable drugs to the US. Strict regulatory compliances are necessary for every pharmaceutical product and the quality standards are expected to be even higher in the case of sterile injectable drugs. Such strictures would help in ensuring that the product manufactured in these facilities would be of highest quality standards and absolutely safe for consumption by critically ill patients. Therefore, we believe that the FDA’s enforcement of stricter Good Manufacturing Practice (GMP) standards will positively impact the industry. Furthermore, the recent introduction of Generic Drug User Fee Amendment (GDUFA) by FDA is expected to approve generic drugs at a much faster pace. This will lead to increase in the availability of injectable drugs in the US market. Business is always about rising to meet shortages and improve gains. Companies known for their excellence in managing sterile facilities have taken cognizance of the supply shortages and set up new injectable facilities. Hence, according to my opinion stricter FDA regulations have not deterred companies from creating newer injectable facilities.

Bejon Misra Dr R B Smarta Founder and Managing Director, Interlink Marketing Consultancy Strict regulatory compliance for injectables is very essential, as this drug delivery system has maximum impact on the health of an individual. In fact, as a result of these regulatory limitations laid right from the manufacturing facilities of injectables to the final end product, not only is good quality assured but quantity delivery as well. The regulations became even more stringent, when numerous companies recalled their injectables. If, players should refrain from this segment is secondary. But, those who would like to enter this segment will have to comply with the necessary restrictions. Demand for essential vaccines and life-saving injectables are increasing in the healthcare system, especially when companies today are focussed on the production of biosimilars and oncology injectibles. Value of this segment will be observed by many industry players in the near future. Continued availability of such injectables will have to be accepted by the industry for eg, autoimmune diseases are increasing at an accelerated pace. This will not only increase the demand for injectables but, also improve patient compliance with the development of self-injectable devices. In India, the manufacturers of generic drugs are focussing their efforts on this niche sector to achieve robust revenue growth. Hence, players today are now including injectables in their product portfolio for enhancing margins and registering significant growth. However, the complexities involved with injectable production, owing to strict GMP norms, make the task a bit formidable.

Founder, Partnership for Safe Medicines - India (PSM-I) In my view, strict regulatory compliances are not the sole reason for entrepreneurs to shut down their lucrative business or for creation of artificial shortages, as in the case of injectables. It is always due to lack of sensitivity towards the patient’s needs, and expectations by players in the supply chain, including the regulators, compel ethical business practitioners to close their business and encourage unethical businesses to grow and flourish. In the Indian context of operations, it doesn’t really matter if the purchases of a product or service, is made from money out-of-pocket or its those of a tax payer. Every player in the injectables business is aware of the fact that, shortages will only encourage profiteering and undue enrichment. This in turn, will provide extra income to the players in the supply chain, including the regulators, which will be at the cost of the poor, voiceless and most neglected consumer. Nobody seems to recognise the fact that, creation of such artificial shortages of injectables, can account to deaths and result in anxieties on the family caretakers. Thus, patients are expected to pay much more than the actual price. Hence, it is not the strict regulatory compliance alone that restricts manufacturers from venturing into injectable production, but it is also due to ineffective regulatory oversight and lack of fear amongst the law-breakers. Till date, I have not seen any kind of conviction or punishment imposed on the culprits, for adopting unfair trade practices. All stakeholders must work in sync to build a healthy supply chain of injectables and encourage the best practitioners produce sufficient quantity of high-quality generic medicines and injectables.

Editorial take Compliances form an essential part of regulating product machinery, which directly impacts people’s health. A sustained dialogue between the authorities and other stakeholders will help devise a suitable path for implementation and address the concerns of manufacturers as well.


0RGHUQ3KDUPD‡ -XQH

18 Insight & Outlook: Policies & Regulations Section 3(d) of the Indian Patent Act

Upholding the standards of innovation With India signing the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), the fourdecade old Indian patent act was amended in 2005. India moved from process patent to product patent benefitting many local and foreign MNCs. During the same time, amendments in section 3(d) of the Indian Patent Act stood tough for some MNCs, thereby preventing the evergreening of the drug. The law intends to promote protection for genuine innovation. We explore the amendment in the midst of this turmoil.

Hardik Ashar pallavi.mukhopadhyay@network18publishing.com

ith recent case hearing on Novartis anticancer drug, Glivec in India, there has been sudden hype and increased interest by the people and media, in general about Section 3(d) of the Indian Patent Act (‘The Act’). The Act was formed in 1970 and amended later in 2005. There is an adverse impression created among some people, who are debating and challenging the law. “It may not be proper to question if Section 3(d) promotes or even discourages new drug development,” says Dr Manu Chaudhary, JointMD and Director Research, Venus Remedies Ltd. “The rhetoric of continuous attack on Section 3(d) has to stop and a complete understanding of the section is warranted. This provision of patent law simply stipulates, what are excluded from the patentable subject matter, in particular matters related to chemical and pharmaceutical nature,” Dr Chaudhary suggests.

W

Understanding ‘The Act’ Section 3(d) states, “The mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant” allowing only patentability of new or innovative molecule. This means that any patentable claim must be proved with proof of significant enhancement in efficacy from the known subject matter. “It can be in the form of new drug or an incremental innovation, but will qualify for patentability only if, benefits of inventive steps taken to prove novelty are duly established for enhanced benefits to mankind (in terms of efficacy) in the light of prior arts with sufficient documentary evidences,” explains Dr Chaudhary. “Section 3(d) forces firms to focus efforts on innovation

and hardcore research, instead of incremental improvement and have patents for every minor innovation,” highlights Bhagat Ram, Assistant Manager, Akums Drugs & Pharmaceuticals Ltd.

Sailing against waves The report titled, ‘The Value of Incremental Innovation: Benefit for Indian Patients and Indian Business,’ appealed to the Government of India to allow patents for incremental innovations and pleaded for abolition of Section 3(d) of the Indian Patent Act. Given to this, many groups have stirred up considerable controversy over the last few years within the pharma industry, splitting MNCs and Indian companies. As ‘The Act’ stipulates that, mere discovery of a new form of a known substance without enhanced efficacy cannot be granted a patent. The Indian Pharmaceutical Alliance (IPA) that represents fifteen major Indian drug companies firmly opposed the 2009 report, published by the US-India Business Council, which asked for modifications in the Indian Patent Act. The report also criticised large MNCs for exploring strategies to extend their hold on the market, including through obtaining patents on minor improvements of existing drugs. At the same time, MNCs led by the Organisation of Pharmaceutical Producers of India (OPPI) consistently maintains that Section 3(d) of the Indian Patent Act restricts innovation and seeks

Any patentable claim must be proved with proof of significant enhancement in efficacy from the known subject matter. Dr Manu Chaudhary Joint-MD and Director Research, Venus Remedies Ltd

clarification to an extent of which, ‘enhanced efficacy’ could be appropriately termed. The IPA-backed report dismissed the general perception of the Act, discouraging incremental innovation, and statistics suggest that there was a significant increase in the overall grant of patents between the period of 2005 and 2009. The number of pharmaceutical patents granted recorded a rise from 765 to 2,373 during 20052009. Further remarkable is the significant increase in patents being granted to non-residents, thereby implying that the Act was against innovations but at the same time it attacked false claims.

past, Indian Patent Office has granted many patents for new molecules that showcase novelty and nonobvious aspects of a patent. Evergreening of patents and delay in launch of affordable generic medicines cannot be afforded in India. Now, it is the time to revolutionise drug development globally. The cost-effective model of R&D of drugs is being revisited by pharma MNCs, and now they are collaborating with many Indian manufacturers and Contract Research Organisations (CROs),who

Bucking the trend “Globally, Line Extension Pharmaceutical R&D (LEPRD) is a contemporary trend (evergreening of patents by patenting drugs on new uses, combinations and new forms of known medicines of existing molecule). This is a serious rate limiting step to innovativeness and non-obviousness, the moral fibre to grant patents. With the honourable Supreme Court judgement, it is to be understood that, amendment in the Act brought to prevent evergreening and to provide easy access to the citizens of the country to life saving drugs has been successful,” says Ram. “India strictly limits the patenting of known medicines and has rejected quite a few applications related to several antiretroviral and cancer medications. In the

Section 3(d) forces firms to focus efforts on innovation and hardcore research, instead of incremental improvement and have patents for every minor innovation. Bhagat Ram Assistant Manager, Akums Drugs & Pharmaceuticals Ltd

provide cost-effective drug discovery and development solutions. The ideal situation would be, to have a balancing metaphor without conflicting interests by giving special allowances for real breakthroughs of a given therapeutic segment ie, lifesaving drugs in case of national emergencies,” Ram adds further. “Under the provision of this section, mere discovery (which is already occurring in nature) of a new form of a known substance would fall outside the scope of patentable subject matter provided, that newly discovered form differs from the known therapeutic efficacy of the known substance significantly. This is clearly in line with the patent law that stands for recognising innovation involving creation by the human intellect and not just mere discovery of something that already exists. If the ‘drug development’ is not a mere discovery work, it will certainly be a subject matter of patent protection. However, even if the subject for which the patent is sought, is just a discovery of new form of known substance (sometimes called as incremental innovation), it would still qualify for patent, only if it can prove that it has substantial therapeutic efficacy over the known one. This has been confirmed by honourable Supreme Court in the Novartis case on 1 April, 2013, and has cleared the air as to what can attract decision based upon section 3(d),” avers Dr Chaudhary.


0RGHUQ3KDUPD‡ -XQH

Projects

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/lifesciences industry. Installation of buttery type automatic double line condom dipping machines in Karnataka Project type: New facility Project news: Installation and commissioning of buttery type automatic double line condom dipping machines in Karnataka. Project location: Karnataka Project cost: NA Implementation stage: Planning Contact details: HLL Lifecare Ltd Mahilamandiram Road, Poojappura Thiruvananthapuram - 695 012 Kerala Tel: +91-471 2354949 Fax : +91-471 2354949 Email : info@lifecarehll.com New affordable anti-malarial drugs for the future Project type: New facility Project news: Development of new, cost-effective antimalarial drugs (lesser than $ 1 per treatment) and ensured access for all. Founded in 1999, the non-proďŹ t organisation Medicines for Malaria Venture (MMV) works with public and private institutions to research and develop new anti-malarial drugs that even the poor can afford. Project location: Switzerland Project cost: $ 500-800 million Implementation stage: Planning Contact details: Swiss Agency For Development And Cooperation (SDC) Freiburgstrasse 130, 3003 Berne Switzerland Tel: +41 31 322 34 75 Radiotherapy services in South West Victoria–stage 2 Project type: New facility Project news: Radiotherapy services in South West Victoria–stage 2 (Warrnambool). Project location: Australia Project cost: $1,50,00,000 Implementation stage: Planning Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India t5FMt'BY t&NBJMQBSNFFUE!UFOEFSTJOGPDPN

Contact details: Department Of Health 50 Lonsdale Street Melbourne, 3000 Victoria Tel : 1300 253 942 www.health.vic.gov.au/ Email: enquiries@health.vic.gov.au Set up a manufacturing of guanine drug intermediate Project type: New facility Project news: Kudos Chemie Ltd is planning to set up a new pharmaceuticals project at Ropar, Punjab to manufacture guanine drug intermediate. Project location: Ropar, Punjab

Project cost: NA Implementation stage: Planning Contact details: Kudos Chemie Ltd 622, Sector 33-B Chandigarh, Punjab – 140507 Tel: 91 (0172) 604344 606341 Fax: 91 (0172) 604344 Email: kudos@cha.i91.net Set up a manufacturing of pharmaceutical injectable formulation syringes Project type: New facility Project news: Emcure Pharmaceuticals Ltd is planning to set up a new pharmaceuticals project at Pune in Maharashtra. The project involves manufacturing of pharmaceutical injectable formulation syringes. Project location: Pune, Maharashtra Project cost: NA Implementation stage: Planning

19

Contact details: Emcure Pharmaceuticals Ltd Emcure House, T 184, M.I.D.C., Bhosari, Pune 411 026 Tel: 020-30610000 Fax: 020-30610111 Email: Corporate@emcure.co.in Set up a manufacturing of Nioret 0.025% Nanogel Project type: New facility Project news: Cabila Healthcare Ltd is planning to set up a new pharmaceuticals project at Ahmedabad in Gujarat. The project involves manufacturing of Nioret 0.025% Nanogel. Project location: Ahmedabad, Gujarat Project cost: NA Implementation stage: Planning Contact details: Cabila Healthcare Ltd 254, 255, Village Changodar, Opp Laxmunarayan Petrol Pump, Behind Zyffne, Sanand, Ahmedabad 382210


20

0RGHUQ3KDUPD‡ -XQH

Tenders

Latest Popular Tenders Brought to you by www.tendersinfo.com Desc : Supply of FPLC (Fast Protein Liquid

UV-VIS-Spectrophotometer Org

Chromatography); Planetry Ball Mill;

: Mysore University

TRN : 16309101

Wire-cut EDM Machine; 34-Channel

Desc : Providing, supplying, installing &

Logic Analyzer with 48 Channel Pattern Generator.

commissioning of uv-vis-

Org

: Power Plant Workshops

TRN : 16488970 Desc : Supply of FT-IR spectrophotometer & accessories. BOD : July 05, 2013

spectrophotometer to department of

BOD : June 28, 2013

Loc

: Islamabad

physics, manasagangotri, mysore.

Loc

: Andhra Pradesh

BT

: Global (ICB)

BT

: Domestic(NCB)

BOD : June 25, 2013 Loc

: Mysore, Karnataka

BT

: Domestic (NCB)

Gas chromatography single quadrupole mass spectrometer

Double beam UV-visible spectrophotometer Org

: Haryana Urban Development Authority (HUDA) TRN : 16524102 Desc : Supply of double beam UV-visible spectrophotometer. BOD : June 26, 2013 Loc : Faridabad, Haryana BT : Domestic (NCB)

Optical emission spectrometer

Org

Org TRN Desc BOD Loc BT

TRN : 16488775

: : : :

Bureau of Indian Standards 16519762 Supply of optical emission spectrometer. July 03, 2013 Ghaziabad, Uttar Pradesh : Domestic (NCB)

Spectroscopy system Org

: Directorate of purchase and stores

TRN : 16206363 Desc : Supply of Laser Induced Breakdown Spectroscopy System (LIBS). BOD : July 03, 2013 Loc : Mumbai, Maharashtra BT : Domestic (NCB)

FPLC (Fast Protein Liquid Chromatography) Org

FT-IR spectrophotometer

: National Institute of Technology

TRN : 16444016

: National Centre for Cell Science (NCCS)

Desc : Supply of gas chromatography single quadrupole mass spectrometer. BOD : July 05, 2013 Loc

: Pune, Maharashtra

BT

: Domestic (NCB)

FT-IR spectrometer Org

: Vision Group of Science and Technology

TRN : 16472606 Desc : Supply of FT-IR spectrometer. BOD : July 08, 2013 Loc

: Bengaluru, Karnataka

BT

: Domestic (NCB)

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

1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India Tel: tFax: tEmail: parmeet.d@tendersinfo.com

An

invite that

rewards as well... Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry.

16-31 May 2013 I Vol 1 I No 22 I `100

www.modernph

arma.in

Scan this code on your smart phone to visit www.mod ernpharma.in

AstraZenec over ` a from promo140 ter AstraZ

In Conversa

tion With 12

A V P S Chakra varthi CEO & MD, Ecobliss India Pvt Ltd and Chairman, IIP, Hydera bad

to receiv crore grante

Schott Fiolax

Special Focu s 13

Special Focu s 15

Modern pharma ceutical packagin An innovat g: ion-driven industry

Academy for

Braille in pharma packaging Scripting a new directiv e

Experts pred ict 22 per cen

SMEs on gla

ss containers

t growth in pha

You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words.

Policies & Regul ations

rma exports

in 2013

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 Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly magazines 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 R. Bastia Senior Editor Modern Pharma

“Disclaimer: Network18 Media & Investments Limited is proposing, subject to market conditions and other considerations, an offer of its equity shares on rights basis and has filed a Draft Letter of Offer with the Securities and Exchange Board of India. The Draft Letter of Offer is available on the website of SEBI at www.sebi.gov.in and the websites of the Lead Managers at www.icicisecurities. com and www.rbs.in. Investors should note that investment in equity shares involves a high degree of risk and are requested to refer to “Risk Factors� in the Draft Letter of Offer. The Equity Shares have not been and will not be registered under the US Securities Act of 1933, as amended (the “US Securities Act�), or any state securities laws in the United States and may not be offered or sold in the United States or to, or for the account or benefit of, “U.S. persons� (as defined in Regulation S under the US Securities Act) except in a transaction exempt from the registration requirements of the US Securities Act and in accordance with any applicable U.S. state securities laws.�

Network18 Media & Investments Limited ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W) Mumbai 400 028 India

18

Foreign Corrup t Practices Act Understanding business objectiv es and complia nce

eneca Pharm A better glass aceuticals will provid AB ea the medicine container can safegua to ` 140 crore financial grant of up rd for a longer to This is what period of time. the next three the Indian firm over the Schott’s Fiolax Academ discussed AstraZ eneca years. “The promoter, in detail y in a conducted Sweden has Pharmaceuticals AB for the SMEs. recent even the leading Schott, one non-repayabl decided a voluntary manufactures of e financial which is used of glass tube nearly $ 22.5 grant of million to by the pharmato made containers 26.5 million over the industry, conduc used three years open Fiolax Academ (FY14-FY16) under a ted an subvention y to on quality agreement,� AstraZeneca of glass used educate SMEs Pharm in contain making a India stated ers. This in a filing of the to the The Lalit, Mumbconference took place AstraZ eneca BSE. at ai, on April Pharm aceuti The main Participants 26. AB would purpose of at the Schott cals provid was to provide the Fiolax Academ of $ 14 million e the first tranch adequate knowleconference pharm y, Mumbai e (` 74 crore) the quality a industry dge about Indian firm of the glass is growing to the rate. We are in and to educate at a fast on the fact year, it added. the current financial just that glass can pharma industr industry enough trying to educate deteriorating contribute ies from the about so that in interna the conditi that region the quality on of the The confere tional standar it could meet the difference Suven Life drug. we nce produce and ds. Further are one the Boltres, Produc was led by the Dr Bettine more, as what they get. in what we patents for Sciences receives was positive The field, we try oldest manufacturer Tubing Produc t Manager, Pharmaceutic and that motiva response and Canadathree NCEs in Eurasia al the smaller to pass on the knowle in the move further t ted us to Services, Schott. Management & Scientif .� dge compan to ies by arrangi ic kinds Apart from of Academ type of glass She explained about what ng these Suven having the y. conference and Li The journey � to make contain tubes should be and semina Academy Sciences receivefe of used Schott’s arrang rs, Schott Fiolex Academ started some es several the drug for ers in order to safegua product patent s lecture two years y pharm rd confere a longer period ago. The initial aceutical college s to various Dr Boltres nce was a for its NCEs,s of includ ing time. said, closed s so and that studen one where invited certain factories two pharmaceutic “It is important for ts they the one in Eurasi in Canad a and companies the the event. al field can be and the persons on a. These that not only industry to unders It was arrange to be a part of of aware about meant to NCEs tand the the are the d part of the cure neurod in rubber cap quality the contain nation, Delhi. the northern making glass that is being but also disorders egenerative er can used reason, Sundee and patent Elaborating Both are equally affect the drug badly. the Academ of the containers. Schott’ in the s are valid till 2028. p Prabhu, important and - Sales &Mark Vice Preside s The grante y should pay a compan nt nations is being carried out Fiolax of the patent d claims eting, Pharm attention to in many across the s include them. With y Tubing, Schott, conference, aceutical of selecti globe with the class said, this place we are trying motive of ve 5-HT the sole creating the answer their where there “Delhi is the one our best to compounds discovered awareness the glass queries are tubes are by Suven about tubing. For Georg Sparsch .� and are being easily availab various cheap plans developed future plans, uh, Preside le. There many compan as present at it were users, to have a conference nt, Schott, and are useful therapeutic agents ies who were the event, for the tubes such as doctor selling these said, “The in the treatm cognit ive s, and educat end Indian importunder our name. Consid regarding ent of impair ment e them the ering ance, better quality we chose this the with neurod associated containers. place to educate egenerative like Alzhei mer’s disease disorders Deficient Anubhav Sharma , Hyperactivit Attention India pharm (ADH D), y a industry Hunti ngton’ Disorder around $ that exports Parkinson s diseas e, 10 billion and Schizo The country pharmaceutic worth of phreni Speaki ng al produc plus pharma has exported $ 10 billion on the develo a. ts per expects cent Venkat Jasti, ceuticals in growth in issues faced pment, 22 include 2012, the current related to dissolut CEO, Suven, “India is the “We are year. and s 90 per cent share of formulawhich Indian pharma said, ion, he said. frontrunner pleased by 10 per cent firms manufa pharmaceutica in export of tions quality the grant these patent ls including of standard medicin cturing global manufacturing of APIs. More than s for our and active formulations 180 and molecu les pipeline of plants are approve es, are way pharmaceutic today one tablet in FDA in India, ahead d by US (APIs) in al ingredient out of four consum being develo CNS arena that are which is the in US or the highest numbe outside US. ped for Europe is ed per cent export world. We expect India’s share disord ers r a local cognit ive 22 market growth in pharma companmanufactured by of the generic with high is year,� told medical need y. unmet L Ramaswamy, the current contrib about to 35 per cent. Hence, Society ution of the Director, the Science for Pharmaceutical Dissolu potential globallwith huge marke Indian Sotax India Managing industr t (SPDS) is tion y.� y for the growth pharmaceutical sidelines of on workin further the a g towards of generic drugs the world improving pharma conven ‘Disso India 2013’ – the quality a pharma is high, Ramaswamy said. in production and tion. of industry needs export, and The achieve trying to new technol innovation ogy, consum the target of every and needs to third tablet sort out various ed globally should be India, he said. made in

T +91 22 3024 5000 D +91 22 3003 4669 F +91 22 3003 4499 E manas@network18publishing.com W www.network18publishing.com


22

0RGHUQ3KDUPD‡ -XQH

Event List

N AT I O N A L E V E N T S PHARMAbiotika

Asia-Arvo

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

Some of the primary highlights of this conference will be interactive session, papers, abstracts and programs. Masses from all over the world are welcomed to be the parts of this conference. Topics that will be discussed in Asia Arvo are genetics of AMD, understanding AMD, reprogramming and regeneration, gene therapy, small molecule screening and drug discovery, model organisms, gene regulation during development and disease, eye development inherited eye diseases, diabetic retinopathy, common eye diseases, signaling pathways, angiogenesis, crystallins, chaperons and heat shock proteins, oxidative stress, aging and eye disease; October 28-31, 2013, Ashok Convention Centre, New Delhi

For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 – 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com

Indian Pharma Expo The Indian Pharma Expo 2013 will serve as a perfect platform for pharma entrepreneurs andinvestors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and suppliers and distributors of pharma products under one roof to exchange ideas; September 20-21, 2013, Pragati Maidan, New Delhi For details contact: UBM Medica India Pvt Ltd Tel: +91-22-66122600 / 66122673 Fax: +91-22-66122626 Email: info.india@ubm.com Website: www.ubmindia.in

For details contact: The Association for Research in Vision and Ophthalmology Tel: +12402212900 Fax: +12402210370 Website: www.arvo.org

CPhI India CPhI India will bring pharma professionals from all over the world to Mumbai and facilitate, initiate and close business deals. It will be a great opportunity for the industry to showcase their products and services while enhancing their brand at South Asia’s leading pharma industry event. Exhibitors will include manufacturers of Active Pharmaceutical Ingredients, Alkaloids, Amino acids, Antibiotics, Antibodies, Antimicrobial preservatives, Antioxidants, Biocatalysts, Biotechnology, Capsules/encapsulation,

AHMEDABAD

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.

PUNE

Gujarat September 20-23, 2013

Maharashtra October 18-21, 2013

LUDHIANA

AURANGABAD

Punjab December 20-23, 2013

Maharashtra January 10-13, 2014

CHENNAI

JAIPUR

Tamil Nadu November 14-17, 2013

Rajasthan Nov 29 - Dec 02, 2013

INDORE

KOLKATA

Madhya Pradesh Jan 31 – Feb 03, 2014

West Bengal February 21-24, 2014

For details Network18 Media & Investments Ltd

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

Chemical synthesis/analysis, Chira intermediates and lots more; December 3-5, 2013, Bombay Exhibition Centre, Mumbai For details contact: International UBM Live Tel: +91-22-67692415 Fax: +91-22- 66122626 / 66122627 Email: vikram.rao@ubm.com Website: www.pmec-india.com

P-MEC India With India’s pharmaceutical machinery and equipment market growing, decision makers from all over the world are increasingly looking at India for sourcing pharmaceutical machinery and equipment. At P-MEC India, visitors will have the unique opportunity to showcase their products in front a large audience, building brand awareness and gaining new leads from over 85 countries. P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide - the “must attend� event in the international pharmaceutical industry. It is a great platform for visitors to showcase high-quality pharma machinery and equipment, meet with key decision makers in pharmaceutical industry from countries, including India, China, US, UK, France, Italy, etc and network and build the brand in one of the world’s

fastest growing pharmaceutical markets; December 3-5, 2013, Bombay Exhibition Centre, Mumbai For details contact: International UBM Live Tel: +91-22-67692415 Fax: +91-22- 66122626 / 66122627 Email: vikram.rao@ubm.com Website: www.pmec-india.com

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

I N T E R N AT I O N A L E V E N T S The Clinical Genome Conference Bio-IT World and Cambridge Healthtech Institute will host the 2nd Annual TCGC: The Clinical Genome Conference is inviting stakeholders from all arenas impacting clinical genomics to share new findings and solutions for advancing the application of clinical genome sequencing. The conference will bring together many constituencies for frank and vital discussion of the applications, questions and solutions surrounding clinical genome analysis, including scientists, physicians, diagnosticians, genetic counselors, bioinformaticists, ethicists, regulators, insurers, lawyers, and administrators; June 25-28, 2013, Hotel Kabuki, San Fransisco, CA For details contact: Cambridge Healthtech Institute Tel: 781.972.5400 Fax: 781.972.5425 Email: chi@healthtech.com Website: www.clinicalgenomeconference.com

International Congress of Toxicology 2013 The theme for the conference is ‘From Basic Science to Clinical and Environmental Outcomes’. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist of keynote/distinguished

lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30 - July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422 Fax: +82-2-566-6084 Email: ict@ict2013seoul.org Website: www.ict2013seoul.org

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11, 2013, Korea For details contact: Terrapinn Pvt Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email: enquiry.sg@terrapinn.com Website: www.terrapinn.com

3rd International Conference on Environmental, Biomedical and Biotechnology 3rd International Conference on Environmental, Biomedical and

Biotechnology is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society. It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society Tel: +86-28-86528465 (China Branch) Email: cebb@cbees.org Website: www.icebb.org

4th Global Drug Safety Conference and Exposition The 4th Global Drug Safety Conference and Exposition will be based on the theme Revitalising Drug Safety – The Decade of the Patient. Drug safety has become one of the most challenging public health issues of our time. It is everyone’s responsibility to take action to address the serious threat to global public health posed by the pressing issues relating to unsafe medicines and the unsafe use of medicines. PSA’s Queensland Branch and the Global Drug Safety Leadership Team will bring together government leaders, drug regulatory agencies, drug safety specialists,

healthcare professionals, pharmaceutical industry, healthcare technology providers, health insurance providers, patient safety advocates, and consumer groups from all over the globe in this premier one-of-kind drug safety conference and exposition; October 14-16, 2013, Brisbane Convention and Exhibition Centre, Brisbane For details contact: Ozaccom+ Conference Service Tel : +61 (0)7 3854 1611 Fax: +61 (0)7 3854 1507 Email: gds13@ozaccom.com.au Website: www.gds2013.org

5th Pan Arab Human Genetics Conference The conference will focus on topics ranging from cancer genomics and NexGen sequencing to molecular profiling and pharmacogenomics. International and regional experts will take to the platform to deliver their lectures on these topics. Researchers will be encouraged to submit their abstracts for oral or poster presentation at the conference. Also, a special feature of the conference will be a workshop on rare disorders; November 17-19, 2013, Al Bustan Rotana, Dubai-UAE For details contact: Meeting Minds Experts Tel: +9714-4270492 Fax: +9714-4270493 Email: pco@pahgc.org Website: www.pahgc.org

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.


0RGHUQ3KDUPD‡ -XQH

Event Report

23

SCDM Asia Conference 2013

Revolutionising clinical data management Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Clinical data is a key asset. It is of immense importance for the pharmaceutical market. Changing regulatory scenario coupled with increasing patient awareness along with need for continuous innovation has propelled the need to streamline clinical data management protocols. With major realignments in operations ruling the pharma industry, the Society for Clinical Data Management (SCDM) recently organised a conference to educate and simplify data management processes for managers across the globe.

T

he Society for Clinical Data Management (SCDM), a nonprofit international organisation founded to advance the discipline of clinical data management, recently organised its first conference outside US. The conference was a multidisciplinary event, wherein leading national and international experts provided thought leadership. The theme of the conference was, ‘The Changing Landscape of Clinical Data Management (CDM): Transformational Trends and Technological Innovations.’ The event was held at The Lalit Mumbai on 31 May and 1 June, 2013. CDM is transforming data management as the world is moving faster towards big data. Individuals play a pivotal role in transforming data into intelligence, to aid drug development. The goal today is to analyse and harness big data. Paula Brown, President of Clinical Development, Quintiles, who was one of the keynote speakers at the event said, “Big data will drive targeted medicine. It will help go deeper into the science of the disease, understand disease causes and real world outcomes.” Today, big data can be used for

Experts deliberating at the conference and keynote speaker, Paula Brown (L) receiving a token of appreciation from Chairperson of SCDM

feasibility analysis, to strengthen quality, accelerate timelines and increase the likelihood of successful results. V K Raman, Head of Global BPO Services, Tata Consultancy Services (TCS) elaborated on the changing landscape of clinical data management, which would positively influence the unmet needs of emerging markets. Social media is one of the fastest evolving tools to assess data. Raman further added, “Ensuring patient safety and data privacy is the need of the hour. Emerging markets need to form

more partnerships, involve regulators and gather diverse knowledge from various industries to better integrate the system.” The two-day conference saw the confluence of more than 100 delegates from over 7 countries. TCS was the knowledge partner, while PAREXEL and Quintiles were the associate sponsors for the event. Clinical research professionals across various segments including project management, clinical operations, data management, biostatistics and medical writing - both from learning

and networking perspective attended the event. Jennifer Duggan, Chairperson, SCDM said, “We want to support clinical data managers from around the world. Currently, our organisation comprises around 2,400 people. We are working with regulatory bodies across the globe, educating managers and conducting online training programme for people across the globe. We are looking forward to hosting conferences in other countries in the coming years.”


24

0RGHUQ3KDUPD‡ -XQH

Book Review

Editors: Chris J Van Boxtel, Budiono Santoso, I Ralph Edwards Price: ` 15,000/-

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

Manufacturing of Pharmaceutical Proteins

Editor: Stefan Behme

The field of biopharmaceutical manufacturing is significantly different and unique than the rest of the industry. The author has put together a great compilation of the various aspects of biological protein manufacturing in this book. The book starts off with an introductory chapter, which revises all the basic concepts of cell, culture systems, bacterial sources, vaccines, immunity and different product groups available. Part 2, describes the principles of various manufacturing processes in biological space. The processes in Active Pharmaceutical Ingredients (API) manufacture and product manufacture are individually broken down and their concepts explained. The processes of cell banking, fermentation, purification, formulation, filling and packing are described in detail. It elaborates the quality control and analytics in biological manufacture. The various concepts of analysis – the method path, the substance path and the pharmaceutical path are well elaborated in this section. Part 3, deals with the interaction of biologicals with the body and the drug safety issues arising from the same. Part 4 talks about quality assurance principles and the issues with respect to biological manufacturing. Part 5 sheds light on the regulator’s legal aspect to biological industry and includes FDA, EMEA, German and Japanese regulations in its description. Part 6 and 7 describe industry’s viewpoint by including concepts in facility designing, sterile facilities, QC labs, planning, construction and commissioning of manufacturing plant, costs and product sales, investment principles, appraisals and analysis.

Price: ` 7,730/-

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

Drug BeneďŹ ts & Risks – International Textbook of Clinical Pharmacology This book is considered as a must-have textbook in clinical pharmacology. The revised second edition comes with new drugs, recent data and newer therapy strategies. The book is divided into two major sections. Section I deals with general principles of clinical pharmacology and is divided into two parts. Part A is an introductory take on the medicinal products with chapters on history, beginning of therapeutics as a science, pharmacoepidemiology, economics, drug policy, drug regulations, drugs in developing countries and drug development. Part B describes the hardcore principles of clinical pharmacology beginning with chapters on pharmacokinetics, pharmacodynamics, drug therapy in special cases like children and elderly, adverse drug reactions, drug-drug interactions, drug misuse – abuse, and poisoning. Section II deals with individual drug groups acting on various systems of the body. Section III deals with managing and treating individual clinical syndromes ranging from symptomatic treatment, emergency medicine, cardiac and renal conditions to oncology. A great book for clinical pharmacologists, pharmacists, physicians and medical students.

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

Yes! I would like to subscribe to Modern Pharma for... Â… 1 year (24 issues) `1200/Fill all details in capital letters Name : Mr/ Ms. :..................................................................................................................................................... Organisation : ......................................................................................................................................................... Please send my copy to : Â… Residence

Â… Office

Â… Factory ( Kindly tick only one )

Mailing Address : .................................................................................................................................................... City : ............................................................................ State : ................................................................................. Pin : ......................................................................................... 1-15 June 2013 I Vol 1 I No 23 I `100

Telephone : (O) ..................................... (R) ......................................... Mobile : ................................................. www.mod ernpharm a.in

Scan this your smartcode on phone to visit www.mo dernpha rma.in

E - mail : .........................................................Subscriber’s Signature : ..............................................................

In Convers

ation With

11

S C Sehga l an and Ozone GroupManaging Direct or, of Comp anies

Charim

Intas plans to raise crore by ` 1,000 IPO Ahme da

How will

Special

Focus 12

FDI in pharm a retail Against all odds‌

Roundta ble 17

How can chemists better with integrate pharma companies?

Facility Visit

ACG Pampa

c,

18

Talegaon manufacturb a d - b a s e d (Pune) Providing innovative er, Intas dr decided packaging Pharma u g to Reputation solutions has through raise around ` 1000 crore its take too built over the plan. The Initial Public years does long to Offer (IPO) destroy. recently 40 per centcompany receiv With Ranbanot conduct pleadi pay a whoo ng guilty, and es aroun of its sales xy Ranba of the past and its from overs d and ensur xy move gross reven part of drug ping $ 500 millio agreeing to s forwa eas ` 3,000 and profes ues cross n fine, safety rd with e that crore. Mean pharma aroun The recen value this industry settlement, the as a We are sionalism in everyt integrity while banke d t case Indian fully comm is abuzz looming that this hing we company has quest with the than ` rs high case over itted do. may standa to the to 5,000 crore impac of Indian upholding be ions have on credibility The optim currently the indust t and all otherrds that patien generics . The prommore istic part believes ts, prescr the independen firms, the of quality ry. oters of the and Chrys hold around that ibers Time will stakeholders expec industry 85 per integrity t auditing firms, authority of the ‘India such cases do Capital t.� only cent 15 per not far will n’ the corpo of Indian holds a cent in be intere cases occuri image as they badly deter these stepstell so as to rate stake of firms and Intas. Chrys is a Priva help are ‘one-o and statem how advan sting to see it will of the industng rarely. While te dd’ comp in salvaging Capit how tage had invest Equity (PE) the pessim ents the indus any image firm, whichal increases of the current China takes believe that ry are holding ed ` 300 ists try and ? before situation the MNCs $ 500 millio their guns and Intas had crore last Indian generi lead it alread for the year n is impac the mark y has over and the Indianhave been attrac planned cs marke ets. Indian generi t that this will a ‘kind’ fine ted towar the Will to hit pharma introd have on ds plants the number t. market the 2005, uction of Post the cs industry. of post the in India Glenmark product recent be affecte FDA-approved 100 per Will Japan Sawhney, patents happenings d in cent According recalls three 2006 the ese CEO in FDI in long run? and other and , Arun & Mana from Ranbaxy, drugs pharma MNCs Phar mace to US FDA, ging prospects the country’s in more buying Indian strong Glenmark different stated that, “Ranb Director, for gener firms? Will shy away stringent growt Glenmark utica ls Howe company ics FDA get have taken today. The axy is a form ver, recent spate and biosimilars.h Indian firms? on granting Generics, subsi diary , multiple approvals steps we There are of Glivec is recall of lots of its arising the wide- over the recent many questi to disapproval, issues in the with this US mark Zita and ranging three drugs ing years reflect notici board and et case. efforts Zita-met ons approval from notification due to ‘odd of comp managemen of the curren and of policy ng how well the It will be worth smell’. issued by t comp ulsory licences other approvals t to addre Indian makers that the A drug ss certain US might anies move because voluntary drug major has FDA said when they amid this scenarand Indian compwary of Indian make these business recall of initiated io, anies. laws and tablets their busine move global its Gaba 600 mg, to under a and 800 big scann ss practices will do 500-count pentin Every er. be pharmaceut Pravastatin mg, 500-count bottle to pass Parita Dhola 90-count Sodium tablet bottle; through ical product proce ss. has s 40 mg, dissolution bottle; kia tablets and This testin Topir classi 200 mg, testin g g ficatio from the 60-count amate helps growing n of the produ ct’s traits. in mark identificatioUS market follow bottles and better et demands The ing n for The recall of the problem. the for Pharm testing proce improved was initia Class-III sses. Socie (SPDS) aceutical Disso ted which lution Scien ty has situation FDA define under Internationa organised in ce d as its 1 st to a violat which use of l Symp Annu or expos ‘a Disso ive produ osium India ure cause adver Conferenceal ct 4 th at The 2013 on se health is not likely to , Lalit, Mum May 3 rd and consequenc is focus bai. sed es.’ US FDA technology on introductionThe event on Wock imposes ‘impo , innov issues faced hardt rt alert’ ation and of new Delegates Wockhardt at the inaugu related Dissolution to ‘disso various the ration cerem ire of US is next in line lution.’ types is vital predictable ony of the to of proce increa as it is a plant FDA. It imposed face the DISSO-2013 test for operated medicine the going sing. In comin sses is the by the genera ban on maker also g years, to have at is called in human body. effect of registered ic drug we are dissolution ointments.� In April Aurangabad, This test Mahr the actionin vitro test as which is and participated , testing Dr L Rama Supporting FDA had Wockhardt said ashtra. the first in and is perfo of medicine it simulates the conte for on dissol mega event the event, carried swamy, that the Sotax, its inject out in ution focussing said, “This Managing Direc xt, dissolution rmed on a mach the body ables plant an inspection The event . that we in Maha at ine called in Auran tester. was released arranged was the first tor, the Chair rashtra, gabad Before are hopin in form 483s time this manship organised under and getting the globa the market, Nayak g for more conference to the comp had issued 70 provi . 483 is l We Pharm , President-T of Dr Vinay per cent de such any. issued produced pharmaceut echnical, G aceuticals ical medic of peopl maximum inform events and when inspe A form conditions undergo e from Alembic Ltd. Mana ines ation to ctors Vinod dissolution that they violate the Ltd ging Director Dr L Ramaswam Disso Indiathe industry.� believe see Consultant P Shah, Pharm testing. US rules, of Sotax y, is the 2013 event emin ent the FDA. according may without , said, “No drug aceutical event and Organising Secret India Pvt witnessed pharmaceutprofe ssion als to An FDA increasingdissolution test. can pass The Scient the General Secret ary of this from ical impo indus is being The Wock rt ban can ific session ary of SPDS With variations try. Disso the and attended be costly s were progra execut . hardt of produ the from R&D, India however, by the mana geme . mmed Dr Mang ed under the chairm professiona said it cts Acade QA nt, restore al Nagar ls mia. As and QC as well most of should be able Pharmaceuti senker, HOD anship of many as as that ($ impact to & Profes cs, Bomb 100 on 300 deleg the Pharmacy, Adaptive ay Colleg sor nine mont revenues) within million ates Mumbai. Biotechnolo e of annou hs six by nced shifting elsewhere. gies to production collaboratio that it has entere recently Anubhav scenario,� “That is a throughput Sharma n agreem d worst Myers Squibb next-g ent with into a charac Chairman, said Habil Khor -case terise the eneration sequen Bristolimmunologi (BMS) for the akiwala, Wochkardt repertoire cing to recept The news discovery cal bioma . of T and Under “We of being ors. Application rkers in has sent of the the collab of this techno B cell BMS are delighted oncolo explor the price oration, use its 7-month company share Adaptive gy. to assess ed in cells of cancer logy is bioma to help uncov to collaborate with propr low. the assay, immu ietary immu s to will the er immu rkers patients, a ne nological immune impact of treatm said Chad of response to biomarkers noSEQ, to identif profiling system cancer agents tool to Robin and evalua ents on Adapt identify response. that may inform y potential ive Biotec s, CEO and Found ,� patient popul ted as a might be The immu about drug hnolo with BMS er, noSEQ assay targeted more likely to ations who is a real gies. “Collaborati uses high ours that win for ng respon therap companies are ies based d to immune understandi committed to like status. on their deepening the host ng of the interac the immune tion cells thems system and between elves.� the cancer

DISSO IN

the Ranb

axy case

DIA begi

Adaptive sign s

http://e

biomarker discovery

shop.in

ns with

affect Ind

a focus

ian drug

on qual

collaboration agreement with Bristol-M yers Squibb

fomedia

18.in

makers?

Please find enclosed cheque/DD no ................................................................................................................... drawn on (name of bank) .................................................................................................................................... dated .....................................................or ` ...........................................................................................................

ity

favouring Network 18 payable at Mumbai. OR charge my … VISA … Mastercard … American Express Card No. : ........................................................................... Card Expiry Date : .................................................. DOB ................................................................................... CardHolder’s Signature : ........................................

Modern Pharma, Subscription Department, Network 18, A Wing, Ruby House, JK Sawant Marg, Dadar West, Mumbai 400 028. 4ELs&AX E-mail: customersupport@network18publishing.com or customercare@network18publishing.com Terms & Conditions : Your subscription will start from the next available issue. Network 18 will take utmost care to dispatch the copies safely. Network 18 does not take the responsibility of any postal delays and damaged copies dispatched. For more information contact Network 18 subscription department. Above rates are valid in India only.


0RGHUQ3KDUPD‡ -XQH

Products

25

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

Pipetting system It enables users to deliver consistent, reproducible pipetting with higherquality results. Its revolutionary ClipTip interlocking technology locks tips securely into place to deliver an airtight seal on every channel. Available for both single and multichannel pipettes, the F1-ClipTip pipetting system is simple but powerful. With minimal force, each tip is clipped securely on the F1-ClipTip pipette using a patented three-interlocking clip design. The pipette and tip form a complete seal to secure the sample volume in each tip for enhanced accuracy and precision. Features include ergonomic design, lightweight, adjustable 120° finger rest for both right and left-handed operator comfort, 150 per cent increase in air boost to ensure efficient delivery of microvolumes and prevent capillary action for low volume pipetting and volume lock adjustment. Thermo Fisher Scientific Mumbai - Maharashtra Tel: 022 - 6680 3000 Fax: 022 - 6680 3001/02 Email: qfc.customercare@thermofisher.com Website: www.thermoscientific.com

Rotary evaporator R o t a r y evaporator is used for efficient and gentle removal of solvents from samples by evaporation. The evaporator has a safe, innovative design with unique reversing feature for better evaporation. Motorised lift has a ‘safety stop’ function. If the power cuts out, the evaporator piston is automatically lifted out of the heating bath. Rotation speed ranges from 20270 rpm. The bath heats from 20 to 180°C adding versatility by allowing use of water or oil. Digital rotation speed display is on all models. In digital models, temperature control of the heating bath is done by a micro-controller eliminating sudden uncontrolled boiling or ‘bumping’. They have an infrared interface for data transfer from the heating bath to the drive unit and RS 232 interface for PC remote operation with Labworldsoft software. Control models offer additional functions like integrated vacuum controller, integrated solvent library, automatic boiling point recognition, colour graphic display, display of distillation curves, USB interface, etc. Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 022-67162224 / 2222 Fax: 022-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Rotary tablet press Rotary tablet press with double-output and bi-layer tableting features the p a t e n t e d E xc h a n g e a b l e Compression Module (ECM) technology. It offers increase in productivity due to a very short change-over time, enhanced operator protection due to ECM, exceptional flexibility because same basic machine can be equipped with different ECMs. There is a zero-gap closed powder feeder to minimise crosscontamination between layers and to minimise powder loss, specially designed

extraction nozzles and scraper fingers for optimal cleaning of the die table. It can undergo manual or fully automatic first-layer sampling. It also features the patented weight control system, which is exceptionally sensitive and accurate even at low compression forces. Its production capacity lies from 35,000 tablets/hour to 875,000 tablets/hour depending upon the model. Machine size and weight specifications are W = 2000 mm x D = 1500 mm x H = 2250 mm - 6000 kg.

BOD incubator

Shefa Industries Vadodara – Gujarat Tel: 265 – 3074270 Fax: 265 – 3074255 Email: pharma-india@gea.com Website: www.gea-ps.com

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

The temperature range of the machine is from 10° C to 60 °C with + 0.2 °C accuracy and + 1.0 °C uniformity. It features 21 CFR PART11 compliance, log data, event data, audit trail data, e-records and e-signatures, graphical analysis and data acquisition. Other optional features such as scanner, GSM technology, extra tray, hooter systems are also available.


26

0RGHUQ3KDUPD‡ -XQH

Products

Stainless steel pipe and tube Stainless steel seamless welded pipe, tubes and ‘U’ tubes, large diameter welded pipe in various sizes, grades and specifications are available. Materials used are austenitic, ferritic, duplex and super duplex stainless steel. They conform to ASTM, ASME, DIN, NFA, JIS standard. Size range for welded ranges from 6.0 mm OD – 1016 mm OD and for seamless 6.0 mm OD – 323.9 mm OD. Similarly thickness varies from 0.6 mm – 25 mm for welded and 0.8 mm – 25 mm for seamless. Length is upto 30 metre long. Application industries include refinery, petro-chemical, food, pharmaceutical, fertilizer, oil & gas, breweries, sugar, ship building. Suraj Limited Ahmedabad – Gujarat Tel: 079 - 27540720/21 Email: suraj@surajgroup.com Website: www.surajgroup.com

Sterilisation and depyrogenation tunnel AX / VX series tunnel is specially designed for ampoules and vials with various capacities. The tunnel is energy efficient and suitable for online production in conjunction with washing and filling machines. The receptacles are treated with sterile air through entire travel for thermal treatment. It features a control system, data recording facility and infeed/outfeed chutes. Sterilisation and depyrogenation is based on 3 Log reduction cycle at 296.4° C. Also present is programmed cycles for auto/manual operation, shutdown and temperature mapping. Some of the optional features are sleep mode during non-productive hours, cool zone sterilisation before start-up, separate cooling module for cooling zone air re-circulation. Venera Biotech Systems Pvt Ltd Pune – Maharashtra

Tel: 0251 - 2552993 Fax: 0251 - 2569695, 2559695 Email: sales@venera.in, venera@vsnl.com Website: www.venera.in

Water bath This equipment offers superior temperature accuracy, rugged construction with minimum heat loss. Pump circulation flow gives maximum uniformity of temperature. Water bath is used for incubation in water media, immersion requirements, external circulation to spectrophotometer, jacketed glassware, etc. It is also used for heating of solution/liquids in a jar flask and many other applications in the field of research, development, production and quality control. Sarbi Mumbai – Maharashtra Tel: 022-26049538 Email: sarbi1@vsnl.com Website: www.sarbi.com

V blender V blender is an ideal mixer for cream, ointment and paste. All parts are made of stainless steel and are highly polished. The blender can produce a homogeneous mixture. Technical specifications are 43 Kg weight, 68 kg gross weight, 660mm x 482mm x 630mm dimension and electrical specifications 0.25HP, AC, 230V, 50Hz, 3Ph. Cronimach Machinery Ahmedabad - Gujarat Tel: 079 – 25861418 Email: info@cronimach.com Website: www.cronimach.com

Three phase thyristor power controller It features 15KW and 30KW models, operates on 3 phase supply with auto/manual operation. It is suitable for 3 or 4 wire star configuration / 3 or 6 wire delta configuration. It accepts (4-20)mA / (0-5)VDC / (0-10) VDC control input and has an adjustable voltage limit per phase. The design is simple and modular for easy servicing of cards and thyristors. Thyristor power pack has a varied application and can be used with heating elements like nichrome, tungsten, kanthal, super kanthal, silicon carbide, molybdenum, infrared, etc. where precise and accurate power control is required. It provides significant power savings with respect to conventional contactor type temperature control system. Libratherm Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 28963823, 28960569 Fax: 022 – 28964769 Email: sales@libratherm.com, libratherm@libratherm.com Website: www.libratherm.com

Sanitary tubes fitting A wide range of sta in less s t e e l sanitar y t u b e fittings for pharma, food, beverages, breweries, cosmetics and allied industries are offered. The range includes bends, Tees, reducers, pipe, support and sight glass, etc. These are available in tube OD sizes ranging from ½” to 6”. End connections available are triclamp, DIN and SMS. These fittings are manufactures from SS-304, 316 and 316L, duly electro polished. All these products conforms to cGMP and FDA standards. Elastomers offered are of food grade and can be offered in EPDM, neoprene, silicon and viton. Cris Engineering Works Mumbai - Maharashtra Tel: 022-2685 9440, Mob: 09892273314 Email: roque_ferns@rediffmail.com Website: www.criseng.com


0RGHUQ3KDUPD‡ -XQH

Products Portable data logger This portable data logger is fully validatable and is designed for regulated industries. The specification incorporated in the logger serves every simple and critical process control applications of the industry. It is an economical and easy-to-use temperature and relative humidity data logger. With its precision calibrated internal temperature and relative humidity sensor, it simply requires the user to place the logger in the field and leave it to record. Once the desired information has been recorded you can plug the data logger unit into your computer and begin downloading and viewing the logged data and graph with miniLog Express software. No cables or wires are required, making it ideal for quick and accurate temperature and humidity measurements in a variety of applications. Each data logger has enough internal memory to store up to 40,000 readings. Enviro Technologies Thane - Maharashtra Tel: 022-64646500 Email: ankit.s@enviroworld.in Website: www.enviroworld.in

Reaction vessel

These industrial reactors are fabricated to accuracy using qualitative material and are constructed either in M.S. or S.S. These vertical reactors are provided with different capacities ranging upto 25KL and comprise of the following construction elements: sturdy construction, leak proof and durable finds application in various industries such as pharmaceutical, fertilizers, food and dairy industries, petrochemical industries, pulp and paper industries, dyestuff and chemical engineering industries. The various types of vessels available are jacketted reactor, limpet coiled reactor and internal coil reactor. Aries Engineers Thane - Maharashtra Tel: 022-28555751 Fax: 022-28555776 Mob: 09323649078, 09930992671 Email: ariesengineers@yahoo.com, info@ariesengineer.com Website: www.ariesengineer.com

Salt aerosol filter tester It is available in size 71cm W × 69cm D × 89cm H (28” W × 27” D × 34” H), weight 150bs (68kg), 0.075μm count median diameter, 0.26μm mass mean diameter and gravimetric standard deviation < 1.7. Concentration is 35 to 45 milligrams per cubic meter (mg/m3), efficiency upto 99.9995%, pressure 0 to 200 millimeters

of water column (0 to 7.88 inches of w.c.), accuracy ± 2.5% of full scale, flow rate 10 to 120 liters per minute (slpm or alpm). Power re q u i re m e n t is 110VAC/60 Hz or 220VAC/50Hz, compressed air is of 283 SLPM at 5.6 kg/cm2 (10 SCFM at 80 PSIG).

Pharma print cartridge

Rigid tube packaging machine

discharge of the tubes is correctly filled on a bucket conveyor at machine outfeed, with cap facing the operator side, extremely compact tube feeding; tube transport carried out through bushes that proceed with synchro-dynamic movements. The tablet insertion is made with a system that moves them in a positive way by means of a pick & place system. The machine is manufactured in strict compliance with GMP norms. It is made of steel and aluminium with AISI304 stainless steel panels and operating parts are constructed with materials suitable to operate at direct contact with product.

Automatic rigid tubes filling and closing machine is suitable to count and introduce positively, tablets in plastic or metallic rigid tubes, cylindrical-shape. It has a final tube closure with pressure cap and

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

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

27

The pharma print cartridge and felt pad/roller are made for blister packaging machine, FFS machine and coding machine. Absorbing material used is poly porous in various microns varying from 1 micron to 25 micron, depending upon the requirement of customer. The absorbing capacity of these cartridges is quite high and the cartridges are hard so the impression is good as there is cotton cloth knitted sleeves (covering) which is used to avoid direct contact of stereo with roller. The cartridges are made in various ID, OD and length depending on customer’s requirement. The maximum OD can be 85 mm, length up to 300 mm. Process Instrumentation & Controls Vadodara - Gujarat Tel: 0265-235 7228, 232 0756 Mob: 09228753005 Email: batchprinting@yahoo.com Website: www.piccode.com


28

0RGHUQ3KDUPD‡ -XQH

Products

Octagonal blender

Steam steriliser

Silicone transparent braided hose

Octagonal blender features discharge output via. butterfly valve, safety guards provided with limit switch interlocked to motor to ensure safe operation, bump- less rotation. All contact parts are made of SS 316 as per GMP standard. It has zero retention design. Internal finish conforms 220 grits to 320 grits, outside mat finish180 grits. Charging drum arrangement with mechanical / hydraulic trolley is provided. Other features include safe earthing systems, optional accessories/ attachments, flame proof construction, PLC with MMI and VFD. Applications include blending of dried granules for tablets and blending of dry powders for capsules. Documentation like DQ, IQ, OQ and FAT is provided with the machine.

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

Silicone transparent braided hose conforms to USP Class VI requirement & FDA 21 CFR 177.2600. This braided hose is made from 100% pure silicone rubber by using fully automatic state-of-the- art machineries and technologies. The medical grade braided hose is manufactured under stringent quality control. The braided hose is temperature resistant from -80°C to 250°C (-110°F to 480°F), non-reactive

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

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

to body tissue and fluid and has nonadherence to tissue. It is unaffected by most water soluble materials and is sterilisable by steam, dry heat, ethylene oxide (ET) and gamma radiation. It resists oxidation, ozone and radiation and has an indefinite shelf life. Available size is from 6 mm ID to 60 mm ID. AMI Polymers Pvt Ltd Thane - Maharashtra Tel: 022-28555107/631 Mob: 09223290931 Fax: 022-28555378 Email: amipolymer@vsnl.com Website: www. amipolymer.com

Track and trace system

Track and trace system is powered to create a complete identification and data verification solution for labels on pharmaceutical medical device packaging and healthcare serialisation. It reads 2-D and 1-D barcodes: Data Matrix, GS1128, GS1 dataBar, securPharm and Pharmacode. It can verify correct ID code contents, including compliance with the GS1 Healthcare data standard, supports FDA 21 CFR Part 11 validation compliance with change tracking, double blind and secondary authentication, provides data matrix mark quality assessment during production to detect changes in print quality, verify the accuracy of printed text & skew, detect label misalignment & skew and supports bundle aggregation. Cognex Sensors India Pvt Ltd Pune - Maharashtra Tel: 020- 40147840 Fax: 020-66280011 Email: sisd.support.asia@cognex.com Website: www.cognex.com

Molecular weight detector

Zetasizer μV is a versatile size and molecular weight detector that can be added to any system to boost experimental productivity by maximising information flow from a single experiment. It is a dual integrated light scattering system with particular value for protein characterisation. It uses dynamic light scattering to secure precise molecular size measurement while at the same time offering static light scattering for absolute molecular weight measurement. It allows the characterisation of discrete samples with only 2 μL of material. The instrument can be added to any protein SEC system to bring absolute molecular size and molecular weight capability to the chromatography experiment, and avoid the need to calibrate the column.

Malvern Aimil Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 39183596, Mob: 09867368075 Fax: 022 - 39183562 Email: soloni.gosalia@malvernaimil.com Website: www.malvernaimil.com The information published in this section is as per the details furnished by the respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma


0RGHUQ3KDUPDÂ&#x2021; -XQH

Marketplace

Heartbeat of the Healthcare Industryy MODERN MEDICARE is a GHÃ&#x20AC;QLWLYHPDJD]LQHRQKHDOWKFDUH HTXLSPHQW WHFKQRORJ\7KLV PRQWKO\PDJD]LQHSURYLGHVWKH ODWHVWWUHQGVLQGHSWKYLHZV  DQDO\VHVRQKHDOWKFDUHVHFWRU Modern MedicareLVWUHDWHGDV DUHOLDEOHVRXUFHERRNZKLFK IDFLOLWDWHVVRXUFLQJGHFLVLRQVLQ WKHPHGLFDOIUDWHUQLW\²KRVSLWDOV VSHFLDOW\FOLQLFVSDWKRORJ\ODEV QXUVLQJKRPHVDQGGRFWRUV

For further enquiry, write to: b2b@network18publishing.com OR Call us on: 022- 3003 4650 To source product from this magazine SMS: MM (Space) Product Name to 51818

Scan this code on your smart phone to visit www.modernmedicare.co.in

29


0RGHUQ3KDUPD‡ -XQH

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

Pg No

Product

Pg No

Product

Pg No

Product

Pg No

Acoustic enclosure.......................................... 10, 23

Filler ....................................................................... 27

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

Silicone transparent braided hose ............................. 28

Air handling unit ........................................................... 3

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

Molecular weight detector.......................................... 28

Spectrophotometer ...................................................... 29

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

FRP cross arm .............................................................. 29

Octagonal blender ................................................ 28

Stainless steel pipe ....................................................... 29

Analytical instrument ........................................ 21, BIC

FRP epoxy pultruded profile ..................................... 29

Other process equipment ........................................... 25

Stainless steel pipe and tube....................................... 26

Analytical instrumentation ........................................ 19

FRP trefoil clamp......................................................... 29

Pharma print cartridge ....................................... 27

Steam steriliser ............................................................. 28

Aseptic liquid packaging system.................................. 6

FRP/GRP handrail and fencing ................................. 29

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

Sterilisation and depyrogenation tunnel .................. 26

Atlantis .......................................................................... 29

FRP/GRP ladder .......................................................... 29

Pilot/lab scale tablet press........................................... 25

Tablet press............................................................ 17

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

FRP/GRP luminaries................................................... 29

Pipetting system........................................................... 25

Tablet press accessory.................................................. 17

BOD incubator ............................................................ 25

FRP/GRP moulded grating ........................................ 29

Piping system ............................................................... 29

Tablet press machine ................................................... 25

Cable management system ................................. 29

FRP/GRP profile .......................................................... 29

Portable data logger .................................................... 27

Cappers ......................................................................... 27

FRP/GRP pultruded grating ...................................... 29

Pressure tank ................................................................ 29

Capsule filling .............................................................. 17

FRP/GRP step tread .................................................... 29

Pressure vessel .............................................................. 29

Chromatography instrument..................................... 29

FRP/GRP tank ............................................................. 29

Primary and secondary packaging for

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

Gear pump ............................................................ 28

injectable drug ............................................................. 15

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

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

Pump.................................................................10, 23, 28

Cleanroom accessories .................................................. 3

High speed tablet press ............................................... 25

Punch and dies ............................................................ 17

Colloid mill .................................................................. 17

HPLC ............................................................................ 19

Pure water amd steam process .................................... 8

Coloumns and chemistries......................................... 19

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

Reaction vessel ...................................................... 27

Comminuting mill ...................................................... 17

Informatics............................................................ 19

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

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

Lab furniture........................................................... 3

Rigid tube packaging machine .................................. 27

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

Labeler........................................................................... 27

Roll compactor ............................................................ 17

Cooling tower solution ............................................... 29

Laboratory equipment ................................................ 29

Roller compaction system .......................................... 25

Dehumidifier rental ............................................. 11

Laboratory glassware.................................................BIC

Roots blower ..........................................................10, 23

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

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

Rotary evaporator........................................................ 25

Double sided rotary .................................................... 25

Large diameter welded pipe ....................................... 29

Rotary gear pump ....................................................... 28

Water bath .................................................................... 26

Dry van pump .......................................................10, 23

Light pole and utility pole.......................................... 29

Rotary tablet press ....................................................... 25

Waters sunfire .............................................................. 29

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

Liquid handling product ................................... 29, BIC

Salt aerosol filter tester ........................................ 27

Welded pipe.................................................................. 29

Empower ............................................................... 19

Medium speed tablet press ................................. 25

Sanitary tube fitting .................................................... 26

X select HPLC column ........................................ 29

End packaging machine ............................................. 27

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

Seamless pipe ............................................................... 29

X bridge ........................................................................ 29

Advertiser’s Name & Contact Details

Advertiser’s Name & Contact Details

Temporary cooling ...................................................... 11 Three phase thyristor power controller .................... 26 Tooling and spare ........................................................ 25 Track and trace system ............................................... 28 Trained manpower ...................................................... 11 Tubes ............................................................................. 29 Turnkey solutions for biotech and pharma industry .........................................................BC

U tube .................................................................... 29 UPLC............................................................................. 19

V blender ............................................................... 26 Vacuum booster pump .........................................10, 23 Vacuum system ......................................................10, 23

Water analysis instrument .................................. 29

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Advertiser’s Name & Contact Details

Pg No

Aeron Composite Pvt Ltd

29

Advertiser’s Name & Contact Details

Pg No

Fabtech Technologies Intl Pvt Ltd

BC

Pg No

Praj Industries Ltd

8

Suraj Ltd

29

T: +91-79-65258500

T: +91 - 22 61592900

T: +91-020-2290 5000

T: +91-79-27540720

E: info@aeroncomposite.com

E: sales@fabtecheng.com

E: info@praj.net

E: suraj@surajgroup.com

W: www.aeroncomposite.com

W: www.fabtecheng.com

W: www.praj.net

W: www.surajgroup.com

Ani Engineers

28

GMP Technical Solutions Pvt Ltd

FIC

Pg No

Salesworth Synergies Pvt Ltd (Rommelag) 9

Technical Drying Services (Asia) Pvt Ltd 11

T: +91-2752-241479

T: +91 -22 66083790

T: +91-80-25274495

T: +91-124-4012851

E: anivarya@sancharnet.in

E: prashant@gmptech.net

E: mail@salesworthsynergies.com

E: tdsmarketing@pahwa.com

W: www.anivaryapumps.com

W: www.gmptech.net

W: www.rommelag.com

W: www.tdsasia.net

Cadmach Machinery Co Pvt Ltd

25

Integrated Cleanroom Technologies Ltd 3

Skytech Systems (India) Pvt Ltd

21

Waters (India) Pvt Ltd

T: +91-79-25841491

T: +91 40 27165311 / 5316

T: ‘+91-022-4153 3333

T: +91-80-28371900

E: info@cadmach.com

E: info@icleantech.com

E: info@skytechindia.com

E: waters_india@waters.com

W: www.cadmach.com

W: www.icleantech.com

W: www.skytechindia.com

W: www.waters.com

Chemical & Process World

26

Karnavati Engineering Ltd

17

Sotax India Pvt Ltd

7

Weiler Engineering Inc

19

6

T: +91-022 3003 4650

T: +91-2764-241464

T: +91-022-42950191

T: +91-847-531-6733

E: cpw@network18publishing.com

E: info@karnavationline.com

E: sotaxindia@sotax.com

E: solutions@weilerengineering.com

W: www.karnavatiengineering.com

W: www.sotax.com

W: www.weilerengineering.com

Everest Blower Systems

23

Loba Chemie Pvt Ltd

BIC

SS Packaging Industries

27

West Pharmaceutical Services

15

T: +91-11-45457777

T: +91-022 66636663

T: +91-11-45072942

T: +91-040 -49401111

E: info@everestblowers.com

E: info@lobalife.com

E: info@sspackaginggroup.com

E: alagu.subramaniam@westpharma.com

W: www.everestblowers.com

W: www.lobalife.com

W: www.sspackaginggroup.com

W: www.westpharma.com

Everest Blowers

10

P R Corporation

29

Sunjay Technologies Pvt Ltd

29

T: +91-11-45457777

T: +91-22-24109921

T: +91- 22 6662 4330

E: info@everestblowers.com

E: prc_rcshah@yahoo.co.in

E: info@sunjaytechnologies.com

W: www.everestblowers.com

W: www.indiamart.com

W: www.sunjaytechnologies.com

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Our consistent advertisers


RNI No: MAHENG / 2008 / 27125, 3RVWDO5HJG1R*10'3RVWHGDW3&6WJ2I¿FH*320XPEDL 2QWK WK2I(YHU\0RQWK'DWH2I3XEOLFDWLRQWK2I(YHU\0RQWK

32


Modern Pharma june 16 30