Express Pharma July 16-31, 2014 by Indian Express

VOL. 9 NO. 18 PAGES 96

www.expresspharmaonline.com

Cover Story CSR Special: Healing the world Market ‘India is crucial to us for the future’ Management Will India’s IP law and policy ‘Modi-fy’? 16-31 JULY 2014,` 40

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CONTENTS Vol.9 No.18 JULY 16-31, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

MARKET

IN A SWEET SPOT No other industrytouches a billion lives as much as pharmaceuticals, with a potential to improve health outcomes of people worldwide,yet it is in a midst of a fluxwhen it comes to CSR | P42

Bangalore Neelam M Kachhap Delhi Shalini Gupta

'INDIA IS CRUCIAL TO US FOR THE FUTURE'

CIPLA PLANS INVESTMENT IN ITS UK SUBSIDIARY

PHARMA ALLY

DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

P45: INSIGHT

Senior Artist Rakesh Sharma

CSR: An opportunity for pharma companies

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P48: CLINICAL UPDATE Minimally invasive bone forming product ALLOB in Phase I/IIa trial for delayed union fracture

P55: PROFILE

MANAGEMENT

WILL INDIA’S IP LAW AND POLICY ‘MODI-FY’?

‘OUR SOLUTIONS SAVE UP TO 30 PER CENT OF ENERGY COSTS AND REDUCE CARBON FOOTPRINT’

PACKAGING SPECIAL

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P58: VENDOR NEWS Phenomenex adds two phases to Lux Chiral Bulk Media Line for preparative chromatography

P87: INSIGHT Listening is the key

‘ASIA WILL STILL REMAIN THE REGION WITH THE HIGHEST GROWTH RATES’

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Budget 2014: Will implementation live up to intent?

had ended my last edit with the hope that this year, unlike previous years, the pharmaceutical sector’s hopes would not be as fleeting as a shooting star. Going by the initial reactions , this is unfortnunately the case this year as well. There is a clear intention to deliver on certain aspects mentioned in the BJP election manifesto, but there is disappointment that the proposals are not as bold as expected. To that, some say, let’s give them a chance to live up to the manifesto. Here’s my take on a few of the proposals with a caveat that these are but first impressions. First, the bitter pill. Service tax exemption on technical testing of newly developed drugs on human participants has been withdrawn which means that investigators in clinical trial programmers may now be subjected to service tax. This will definitely make clinical trials more expensive and be a disincentive. Added to the regulatory knocks which the sector has already taken in the past two years, this is sure to invite many recriminations from the industry. Another negative is that while the FM has promised that the Government will take effective steps to revive SEZs, he refrained from giving MAT relief for SEZs; a sign of a tough stance moving away from tax sops. This will no doubt disappoint in the short and mid term but will prove to be better in the long term. Possibly only the second reference specific to the drug industry was the allocation of funds to strengthen the states’ drug regulatory and food regulatory systems by creating new drug testing laboratories and strengthening the 31 existing state laboratories. This is a long over due measure given the import alerts received from global drug regulators. The proposal to establish a ` 10,000-crore venture capital fund for start-ups, incubators and accelerators should hopefully benefit pharma and biotech start ups like drug discovery firms, medical device companies, stem cell research, and nano technology. These projects require a long gestation period to show results and are also more capital intensive than most sectors. Hopefully, this support at the start up stages will propel deserving companies to the stage where they can attract other investors as well.

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July 16-31, 2014

The pharma industry did not get too much special attention and these measures seem like crumbs fallen from the table. The FM has stated his intent,but the devil lies in the details and their interpretation

Another welcome inclusion is that biotech clusters will be set up in Bengaluru and Faridabad; however, the first is already an established (and some say, already over crowded) biotech hub so I hope the FM does a check on which are the promising upcoming biotech hot spots in the country. Let us hope that these measures will not just invigorate pharma and biotech R&D but will also hopefully stop the brain drain. We have to start building a research base for the future in our country so that we can address healthcare needs specific to our populations. The Government will also take up two key initiatives on a priority basis: providing free drugs and diagnosis services. This is a good move but who will monitor the use of these free drugs? Over use of antibiotics has led to multi drug resistance in diseases like tuberculosis, given the propensity to self medicate. Of course, free diagnosis facilities will help increase detection levels and hopefully earlier in the course of the disease so that it will decrease the cost of treatment. That definitely gets a thumbs up. In addition, it will spur demand for these test kits and drugs, making manufacturers happy. This current issue of Express Pharma (dated July 16-31) is a CSR Special so it’s good that the FM has indicated in the budget that slum development programmes will be incorporated under CSR. This is a good move because it builds on existing programmes like health camps and awareness drives already run conducted in such slums in metros by many hospital groups and pharma companies. Hopefully, this will encourage them to scale up these programmes and make them sustained initiatives. The pharma industry did not get too much special attention and these measures seem like crumbs fallen from the table. The FM has stated his intent, but the devil lies in the details and their interpretation. No doubt, we will see more discussion and debate on these announcements as well as hopefully, rational clarifications from the FM himself in the coming days. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

‘India is crucial to us for the future’ With a 5.7 per cent growth in sales in 2013, Boehringer Ingelheim (BI) ranks seventh among its global peers but has a long way to go in the India market. Allan Hillgrove, Member of the Board of Managing Directors, Boehringer Ingelheim, spells out the company’s strategy for growth to Viveka Roychowdhury The financial highlights of 2013 show that while the US is BI’s biggest market (46 per cent), Europe is second (30 per cent) while Asia, Australia and Africa are the remaining 24 per cent. Of the last market, Japan is the largest contributor and contributes 13 per cent of global sales. India does not currently contribute too much to annual sales of BI and the company itself is only around 11 years old in India. What is the strategy for the APAC market, with special focus on the India market. What is the strategy to grow the market share? Internally, we broadly divide the regions into matured and emerging markets. Among the matured markets we have further divided it into two regions: JUSAC (Japan, the US, Australia, New Zealand and Canada) and the European group. India is in the emerging markets group, where we have 18 major countries/groups. We ventured into India relatively recently, only in 2003. So India is still very small from a Boehringer business point of view. But the reason we made it one of the 18 countries/ groups is that it is crucial to us for the future to not only build a presence there but also to make sure that India is being considered when we look at some of the bigger strategic topics. We’ve got a strong market share and well established business in Japan. From a business and industry point

EXPRESS PHARMA

July 16-31, 2014

of view Japan is No 2 for us as a country. We’ve had quite a lot of success in Japan and worked a lot with partners. We see Japan continuing to be important, as well as China becoming more important though currently our market share is lower in China compared to many others. But we are growing above the market in China and we are happy with the way we are growing here. We are well established in the Australia market as well as in New Zealand. So while we came in relatively later into India, compared to most pharma MNCs now we are building our business here as well. We are building the business in terms of the number of products we have on the market, with new products as well. We are also building from a people and growth point of view. Our other new products are also in India: Linagliptin (Trajenta), from our diabetes portfolio is still in its early days in India but is showing success as well as Pradaxa (dabigatran etexilate) for atrial fibrillation. The products we had earlier were from the thrombolyticsportfolio (Actilyse, Metalyse and Micardis) are quite successful as well. So, we are very much in the infancy of building the business, as a mixture of the older products and the newer ones. Our philosophy will be to continue to build slowly, to understand and learn about the market. We’ve got some very good people in India and we are building up both the

impressive, though of course from a very low base. It would be nice to have the same percentage growth in some of the bigger markets! So we are happy with the way the business is shaping.

BI firmly believes in harnessing the expertise of leading academic groups, public research institutes and biotech companies

number and the expertise of people in India. Currently, we have around 500 staff in India. The growth that we’ve seen in India has been

As of now, BI does not have a manufacturing facility in India. Are you looking at the possibility of setting one up as this will allow you to offer products at more cost effective prices which is also a concern as India is a price sensitive market? We do not have any shortterm plans on this point though manufacturing in emerging markets is something that we are continually looking at. We currently do have manufacturing sites in China and Indonesia. In May, the company announced an exclusive global research collaboration agreement with Connexios Life Sciences, a Bangalorebased biotechnology company, for AMPK agonists for the treatment of patients with Type II diabetes. Is the partnership route being seen as an option to quickly grow your presence in India? BI firmly believes in harnessing the expertise of leading academic groups, public research institutes and biotech companies. The research agreement with Connexios is part of this strategy. BI had many challenges in 2013, the biggest one was

probably the US FDA warning letter for its manufacturing site at Ingelheim, citing ‘significant violations’ of the manufacturing process and also mentioned foreign particles detected in batches of active pharmaceutical ingredients (APIs). This issue has since been resolved as of June 2. What were the learnings from this episode? BI strengthened the quality management structure in the Operations Division and formalised a culture improvement programme for employee levels to strengthen the quality mindset and behaviour in the organisation. Additionally, the company defined and implemented corrective and preventive actions (CAPAs) to address FDA findings and intensified collaboration with our own global network and external experts to identify and exchange best practices. While releasing the 2013 results, Dr Andreas Barner, Chairman of the Board of Managing Directors, indicated that numerous changes to processes have been made since the company received criticism from the US FDA in May 2013 on the quality assurance processes at the Ingelheim facility; investments have been made in the sustainable quality of the products and in QA, and the company has taken steps to optimise production process at the Ingelheim facility. What

MARKET was the expenditure that needed to be set aside for this process? In a letter dated June 2, the FDA informed BI about the closure of the Warning Letter that was issued for the Ingelheim, Germany, manufacturing facility. After concluding its recent inspection in March and considering the company’s response with supportive documentation, the FDA determined the quality management and compliance systems of the facility to be acceptable. BI invested more than Euro 130 million in 2013 after receipt of the Warning Letter to address issues and improve standards. Another challenge was the closure of the Ben Venue, Ohio, US facility for sterile injectables, where efforts to improve production without interruption operations were not successful. Over Euro 500 million were set aside in 2013 for ‘extraordinary effects’. Besides, the Ben Venue settlement, what other expenses figure under this category? Other expenses included for example the investment in the quality procedures at the Ingelheim facility with regards to the Warning Letter. Do you anticipate any such ‘extraordinary effects’ expenses in the current financial year? For instance, against the expenditure on upgrading the Ingelheim facility, legal action against Pradaxa regarding its safety? We are confident that the provisions we have allocated this year are adequate to cover ‘extraordinary effects.’ In CY2013, net sales [of the biopharma contract business] declined by around 18 per cent to Euro 449 million as a number of contract manufacturing contracts expired. 15 new contracts were signed in 2013 so what are the

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July 16-31, 2014

'Making More Health' is a global programme BI has in partnership with the Ashoka Foundation, wherein we support 50 social entrepreneurs (three of them in India) working with the community in the field of health growth projections for the biopharma business for FY 2014? A number of contracts expired in our biopharma contract manufacturing business, as expected, last year which resulted in declining net sales. However, we successfully concluded 15 new manufacturing contracts in 2013. This means that we have established the basis for future growth in the biopharmaceuticals business, which we already see materialising in the first months of 2014. And we will, of course, continue to expand our well filled pipelines. We do not publish specific growth projections for our businesses. In early April, US FDA approval broadened use of Pradaxa in the US. Pradaxa was already approved for stroke prevention in patients with atrial fibrillation but is facing litigation concerning disclosure of risks due to severe and fatal bleeding. What impact will this new approval have on the ongoing litigation on the safety concerns surrounding Pradaxa? There has been a comprehensive settlement of US Pradaxa (dabigatran etexilate) litigation at the end of May 2014. The approval of Pradaxa for Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) patients is based on results from three robust phase III clinical trials that demonstrated the efficacy of Pradaxa in the treatment and prevention of repeat DVT and PE compared to warfarin. In a fourth trial, data showed a 92 per cent

reduction in the risk of recurrent blood clots in patients treated with Pradaxa compared to placebo. With regards to safety, results showed that DVT or PE patients taking Pradaxa experienced significantly lower rates of bleeding than those taking warfarin, resulting in a favourable overall safety profile. Following the US FDA approval in early April, the European Commission in June also approved the use of Pradaxa for DVT and PE patients in the European Union. As a global pharma company in India, what is your view on the regulations governing the pharma sector in India? For instance policies regarding pharma patents and IPR, clinical trials and drug pricing? We are aware that India is a price sensitive market and most healthcare spend is out of pocket. We do look at these issues and endeavour to find an India sensitive pricing so that our products are accessible to the patients who require them. Having said that, the question of being rewarded for innovations cannot be ignored. BI, like many other companies, has a large investment in building innovation, we are also spending a lot on research and have an extensive pipeline. We are firm believers that this investment should be rewarded but of course the ability to pay in India is not the same as the ability to pay in many other markets. We do reflect that in our pricing

and we have a solid policy in India to look at India friendly pricing. Could you give us a sense of how the company sees the performance of BI’s products in the India market? In the consumer healthcare portfolio, Dulcolax is a strong brand. On the prescription medicine side, among cardiovascular products, Pradaxa continues to grow well in India. There is an ongoing litigation regarding Pradaxa in the US but we are confident that physicians all over the world will support the product. We feel the clinical trial data shows that it has clear benefits over Warfarin. Actilyse, Metalyse are heritage brands in the cardiovascular portfolio and on the diabetes side, Tragenta has had quite some success in a short time. So over all we are pleased with the performance. We also have an animal healthcare business but that’s still in very early days. Net sales in 2013 have been low, around Euro 14.1 billion, representing a currency adjusted increase of 1.4 per cent. Like many of its peers, BI's growth has been impacted by slowing growth and decreasing margins. What are the long-term growth strategies? Growth will be similar in 2014. We predict that for BI, in 2015 and beyond, we will see growth coming back. Both due to the new product launches in the existing portfolios of cardiovascular, respiratory, CNS as well as newer portfolios like oncology, immunology, and

biosimilar products come through. So we are not expecting growth to pick up in the next year but if we look at a five year horizon, we are sure growth will come back. Given these low growth rates, what is the take of the founding family of BI in formulating strategy etc? They are on the board but are not involved in the day to day management of the company. Strategy is discussed and decided at the board level during the shareholder meets which happens four times a year. We are not publicly traded so we are free to structure our operations with the long term in mind. We believe that success will only come if you have a longer term view than a short-term view of profits. How is BI promoting the case of increasing accessibility to healthcare in India? 'Making More Health' is a global programme BI has in partnership with the Ashoka Foundation, wherein we support 50 social entrepreneurs (three of them in India) working with the community in the field of health. 2200 employees of BI work on these projects in their own time to share their expertise. The Banyan, run by Vandana Gopikumar in Tamil Nadu, uses a community care approach to treat and rehabilitate mentally ill homeless women. Save Life Foundation, headed by Piyush Tewari, is creating a trained network of trauma care first responders in Delhi. Sameer Sawarkar started Neurosynaptic Communciaitons to imporve access to healthcare in rural India through technology and he already has health kiosks running in Bihar and UP and a government hospital in Tamil Nadu. (The correpondent visited Boehringer Ingelheim, Ingelheim, Germany on the invitation of the company) viveka.r@expressindia.com

MARKET COMPANY WATCH

Cipla plans investment in its UK subsidiary The investment will fund the launch of a range of drugs in the areas of respiratory, oncology and antiretroviral medicines CIPLA HAS collaborated on with the UK Government, its intention to make investments of up to £100 million in its UK subsidiary over the next few years. The Right Honourable George Osborne, Chancellor of the Exchequer, Her Majesty’s Government of the UK said, “I am happy to be able to announce that Indian pharmaceutical company Cipla will invest up to £100 million in the UK. The investment will fund the launch of a range of drugs in the areas of respiratory, oncology and antiretroviral medicines as well as research and development, clinical trials and further expansion internationally and in the UK.” “Cipla is one of India’s leading pharma firms and this decision shows the UK’s international strength and attractiveness in this sector as well as its growing importance in Cipla’s longterm strategy,” said the Chancellor. “On the occasion of the 66 th anniversary of the British National Health Service (NHS) Cipla believes that, by providing high quality affordable medicines for patients, it can contribute cost effective solutions for the NHS. We are pleased to be making this investment in the UK. We were impressed with the pro-active support and engagement that the UK Government and its various ministries showed in attracting Cipla to choose the UK as a key hub in our global footprint,” said Rajesh Garg, Global Chief Financial Officer and member of the board, Cipla. EP News Bureau – Mumbai

EXPRESS PHARMA

July 16-31, 2014

MARKET

Actavis completes acquisition of Forest Laboratories Creates an innovative new model in speciality pharma leadership ACTAVIS HAS completed the acquisition of Forest Laboratories, in a cash and equity transaction currently valued at approximately $28 billion. The combination creates one of the world’s fastest-growing speciality pharmaceutical companies, with annual revenues of more than $15 billion anticipated for 2015. In conjunction with the close of the acquisition, Paul Bisaro, formerly Chairman and Chief Executive Officer, Actavis, has been named to the position of Executive Chairman of Actavis; Brent Saunders, formerly Chief Executive Officer and President, Forest, has been named as the Chief Executive Officer and President of Actavis; Robert Stewart, formerly President,

The combination creates one of the world’s fastestgrowing speciality pharmaceutical companies, with annual revenues of more than $15 billion anticipated for 2015 Global Operations for Actavis, has been named Chief Operating Officer; Bill Meury, formerly Executive Vice President, Sales and Marketing for Forest, has been named Executive Vice President Commercial, North American Brands; and David Buchen, formerly

Actavis’ Chief Legal Officer, has been named Executive Vice President Commercial, North American Generics and International. “The combination of Actavis and Forest creates an innovative new model for success in the global speciality

pharma industry, built to compete within today’s evolving healthcare landscape,” said Brent Saunders, Chief Executive Officer and President, Actavis. “Our business model is driven by a broad portfolio of strong brand, generic and OTC products, a commitment to development-focused, result-oriented research and development and the size and scale needed to efficiently and cost-effectively meet the needs of our global customer base. The new Actavis is uniquely positioned to deliver exceptional long-term financial performance and expand access to pharmaceutical products for patients around the world.”

address recognised gaps in healthcare knowledge, in order to improve patient care. The programme includes the launch of an online portal which allows highly transparent and ethical interactions with medical education providers and represents an important milestone in the Merck Serono Medical Education Strategy. Funding is provided to educational institutions such as universities, medical education providers, medical scientists and scientific organisations. EP News Bureau – Mumbai

EP News Bureau – Mumbai

The programme combines grants portfolio with annual €20 million investment to advance innovation and medical education

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July 16-31, 2014

grammes, highlighting the company’s efforts to promote advances in the field of medicine, addressing recognised gaps in healthcare knowledge, and improving the quality of patient care. “Merck Serono has a longstanding reputation as a strong advocate for scientific innovation and medical education, believing that both are integral to helping healthcare professionals bring enhanced care to patients,” said Steven Hildemann, Global Chief Medical Officer and Head of Global Medical and Safety at Merck Serono.

The Grants for Innovation in research identify and fund promising research from across biopharma, including academia, research centres, smaller start-ups and independent researchers. Specific grants focus on areas in which Merck Serono has a strong R&D and commercial presence, including the Grant for Oncology Innovation, Grant for Multiple Sclerosis Innovation, Grant for Fertility Innovation, and Grant for Growth Innovation. The Grants for Independent Medical Education foster the advancement of medicine, and

Donates 500 tubes of REGEN-D to AP CM’s Relief Fund BHARAT BIOTECH has contributed to the Andhra Pradesh Chief Minister’s Relief Fund `7 lakhs value of REGEN-D , to aid faster recovery of victims from gas explosion in Nagaram village of East Godavadri district. The contribution in kind was made in the presence of N Chandrababu Naidu, Chief Minister, Andhra Pradesh and Suchitra K Ella, Joint Managing Director, Bharat Biotech. REGEN-D 60 is an innovative human epidermal growth factor produced by recombinant DNA technology, which aids in accelerated wound healing for first and second degree burns and skin grafts. REGEN-D 60 has been widely studied, clinically researched and well published. REGEN-D 60 regenerates skin faster and reduces the healing time, resulting in faster wound healing with significant reduction in secondary infections during recovery from burns. “We believe this corporate social initiative will complement the efforts by the Andhra Pradesh Government to provide relief to the injured in the gas explosion and aid in faster recovery of victims” said Ella.

Merck Serono’s grants programme to fund scientific innovation MERCK SERONO, the biopharmaceutical division of Merck, has launched Merck Global Grants, a programme that underscores the company’s commitment to funding scientific innovation and independent medical education around the world. The initiative encompasses Merck Serono’s complete grants portfolio, including the Grants for Innovation in Research and Grants for Independent Medical Education. The programme totals an annual investment of Euro 20 million across all grants pro-

Bharat Biotech donates REGEN-D to victims of AP gas explosion

MARKET

Glenmark Generics receives ANDAapproval Telmisartan is Glenmark’s generic version of Boehringer Ingelheim’s Micardis GLENMARK GENERICS has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately. Telmisartan tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis. Telmisartan is indicated for the treatment of hypertension. The approval is for the 20mg, 40mg and 80mg tablets. For the 12 month period ending March 2014, Telmisartan garnered annual sales of $250 million according

to IMS Health. Glenmark’s current portfolio consists of 92 products authorised for distribution in the

US marketplace and 73 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI

continues to identify and explore external development partnerships to supplement and accelerate the growth of

the existing pipeline and portfolio. EP News Bureau – Mumbai

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Receives approval from US FDA DR REDDY’S Laboratories (DRL) has launched Duloxetine Delayed-Release Capsules USP 20 mg, 30 mg and 60 mg, a therapeutic equivalent generic version of Cymbalta (Duloxetine delayed-release capsules) in the US market. DRL's ANDA is approved by the United States Food & Drug Administration (USFDA). The Cymbalta brand and generic had US sales of approximately $5.04 billion MAT for the most recent twelve months ending in April 2014 according to IMS Health. Dr Reddy’s Duloxetine delayed-release capsules USP 20 mg, 30 mg and 60 mg are available in several bottle counts. EP News Bureau – Mumbai

EXPRESS PHARMA

July 16-31, 2014

The company has been in the Chemical Field for over 50 years, developing from the production of Hydrogenated Stearic Acid to the present range of non toxic Strearates. During this period FACI has become one of the world leaders in the Oleochemical market. PRODUCT

COMPENDIAL / Regulatory Status

Applications / Advantages

Magnesium Stearate

USP, NF, PhEur, JP, FCCVll

Lubricant

Calcium Stearate

USP, NF, PhEur, JP, FCCVll

Lubricant

Zinc Stearate

USP, NF

Lubricant

Sodium Stearate

PhEur

Lubricant

Triglyceril and Monoglyceril Stearate

PhEur

Lubricant, Solubilizing agent, Stabilizer, Emulsier

SCOPE Ingredients Pvt. Ltd.

MARKET DEAL TRACKER

Focus on complementary products to develop existing portfolio drives M&A activity M&A ACTIVITY in the pharmaceutical sector was focused on advancing the development of promising products through complementary offerings. In line with the above trend, Merck agreed to acquire Idenix Pharmaceuticals, a US-based biopharma company for approximately $3.85 billion. This acquisition provides Merck with an access to a portfolio of hepatitis C candidates, which complements its hepatitis C therapies that are under development. In addition, the

FIGURE: M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

Source:

FIGURE: VENTURE FINANCING TREND ANALYSIS

Source:

TOP M&A DEALS (JUN 2014) Rank

Date

Target

Acquirer

Deal value ($m)

06/09/14

Idenix Pharmaceuticals, Inc. (US)

Merck & Co., Inc. (US)

3850

06/03/14

Labrys Biologics, Inc. (US)

Teva Pharmaceutical Industries, Ltd. (IL)

825

06/23/14

OAO Veropharm; Limited Liability Company Garden Hills

Abbott Laboratories (US)

629.88

06/24/14

DAVA Pharmaceuticals, Inc. (US)

Endo International plc (IE)

600

06/02/14

Genia Technologies, Inc. (US)

Roche Holding, Ltd. (CH)

350

06/11/14

Medreich, Ltd. (IN)

Meiji Seika Pharma Co., Ltd. (JP)

290

06/17/14

WEIFAAS (NO)

Aqualis ASA (NO)

183.7

06/30/14

Precision Genome Engineering, Inc. (US)

bluebird bio, Inc. (US)

139.9

06/02/14

Oso Biopharmaceuticals Manufacturing, LLC (US)

Albany Molecular Research, Inc. (US)

110

06/20/14

ECR Pharmaceuticals Company, Inc. (US)

Valeant Pharmaceuticals International, Inc. (CA)

Source:

TOP VENTURE FINANCING DEALS (JUN 2014) Rank

Date

Target

Investors

Deal value ($m)

06/16/14

JHL Biotech, Inc. (TW)

Milestone Capital Partners Limited; President International Development Corporation (PIDC); Fubon Financial Holding Co., Ltd.; Taishin Financial Holding Co., Ltd.; TaiAn Technologies Corporation; Hotung Group; China Development Industrial Bank; Kleiner Perkins Caufield & Byers; Biomark Capital; Allen Chao; Undisclosed Investors

06/23/14

Dimension Therapeutics (US)

OrbiMed Capital LLC; Fidelity Biosciences

06/17/14

True North Therapeutics, Inc. (US)

Kleiner Perkins Caufield & Byers; MPM Capital; SR One; Biogen Idec New Ventures; Baxter Ventures

06/04/14

Trevi Therapeutics, Inc. (US)

TPG Biotech (US)

06/04/14

Complexa, LLC (US)

Jafco Life Science Investment; Undisclosed Investors

Source:

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July 16-31, 2014

MARKET transaction would allow Merck to advance the development of a once-daily, oral, ribavirin-free, pan-genotypic regimen. This transaction supports the company's strategy to deploy capital through external innovation to drive future growth. In another key deal, Teva Pharmaceutical Industries agreed to acquire Labrys Biologics, a US-based biotechnology company for approximately $825 million. The addition of Labrys’ LBR-101 programme targeting high frequency episodic and chronic migraine complements Teva’s recent pipeline addition of Zecuity, a therapeutic for the acute treatment of migraine that has been obtained through the acquisition of NuPathe. This transaction allows Teva to continue Labrys’ efforts to advance the LBR-101 programme and adds a migraine prophylaxis dimension to Teva’s extensive pain care franchise, which includes a range of investigational, approved and marketed treatments for migraine, cancer pain and chronic pain. M&A activity decreased in volume and value terms, when compared to the average of the previous six months’ (Dec 2013 – May 2014). According to Datamonitor's Medtrack database, the pharma sector recorded 26 M&A transactions in June 2014, against the previous six months’ average of 31.5 transactions. In value terms, the sector recorded deals worth $7.1 billion, against the previous six months’ average of $15.7 billion. The Indian pharma sector witnessed one deal in June 2014, against the average of 0.5 deals over the previous six months, in which Japan-based Meiji Seika Pharma agreed to acquire an India-based pharma company Medreich, for $290 million. This acquisition enables Meiji Seika Pharma to obtain a manufacturing infrastructure in order to achieve cost-competitive production, capacity expansion and broaden its sales network of generic drugs in India, Asia and Africa. In addition, Meiji Seika Pharma would be able to expand its contract development and manufacturing organisation business leveraging Medreich's blue chip customer base and its expertise in quality control and

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regulatory compliance.

Venture funding Companies raised $139.9 million during June 2014, against the previous six months’ average of $300.6 million. In terms of volume, the sector recorded 10 venture funded deals, when compared to the previous six months’ average of 15.3 transactions.

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision

support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

For more information, visit us at www.medtrack.com

Definitions 1.Deal value trend is based on transactions where associate values have been disclosed. 2.Trend analysis excludes rumored and terminated deals. 3.Value and volume analysis excludes private equity exits.

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MARKET POST EVENT

Conference on ‘Innovations in Oral Drug Delivery Systems’held in Mumbai Organised by Infinity Business Services and supported by I3R Global, the conference aimed to highlight the latest trends and government regulatory guidelines in oral drug delivery systems of India Usha Sharma Mumbai INFINITY BUSINESS Services (IBS) recently organised a day-long conference on ‘Innovations in Oral Drug Delivery Systems 2014’ in Mumbai. The conference highlighted latest trends and government regulatory guidelines for oral delivery in India. The event witnessed the presence of around 50 delegates from (R&D) and formulations areas. Dr Mithilesh Trivedi, Advisor, Techno Drugs and Intermediates delivered the opening address and highlighted the need for many such seminars for the benefit of the industry and hoped that the programme would become better and bigger with time. Trivedi highlighted that in oral drug delivery, many scientific challenges and breakthrough technologies are required to generate novel dosage forms and raise drug delivery to a higher level. He also mentioned about formulations of fast dissolving tablets, highlighting the requirements for ODT and the patented technologies available in the market. Speakers included Dr K Bangarurajan, Deputy drug Controller, Central Drugs Standard Control Organisation (CDSCO), Dr D Rambhau, Director (Technical), Nanoceutica Laboratories, Tohru Kokubo, Product Manager, Qualicaps, Dr Milind Biyani, Director, Aspire Advisors and Dr Ravindra Purohit, Director, RNP Consulting. Bangarurajan spoke about

20 EXPRESS PHARMA July 16-31, 2014

Indian regulatory process for new drugs approval and updated industry representatives about the Drugs and Cosmetics Act besides encouraging the industry to launch new molecules in the Indian market. He also explained the various legal enactments to regulate import, manufacture and sale of drugs and briefed about the well-defined drug regulatory system under Government of India. He also touched upon requirements and guidelines for approval of clinical trials, import and manufacture of new drugs and various categories of fixed dose drug combinations (FDCs). Rambhau explained the challenges in oral delivery of macromolecules. He presented various slides which tried to showcase issues associated with the macro molecules. In his presentation, Rambhau mentioned that heterocyclic drug era is in a slow phase of decline. There are no blockbuster drugs to be released in future. Few new molecular entities which are remaining in this category are going to be off-patent by 2015. Insolubility, resultant poor

The event witnessed the presence of around 50 delegates from R&D and formulations areas of the pharma sector

bioavailability and alarming side effects are the reasons why these molecules did not reap the best benefits. Side effects are mainly because of there distribution to the areas other than the target locus of pathology. He explained that the hunt for efficient molecules, paid dividends and macromolecular entities such as proteins, peptides, nucleotides have been developed into potential therapeutic agents. More than 125

macromolecular entities are already approved by various regulatory agencies across the globe. Besides positive attributes like high potency and low toxicity these molecules are inflicted with delivery problems. Being macromolecules and being vulnerable for the breakdown by enzyme systems there bioavailability is the greatest limitation to unveil their full potential. It is to be hoped that even with these delivery problems these drug molecules will be ruling the therapeutic arena in future because of their high potency and low toxicity. Behind the challenges of delivery of these molecules, hidden is the greatest opportunity to exploit the full potential of these novel therapeutic agents. Continuous efforts are being centred on to find variety of solutions for the effective delivery of these drugs. However, he was optimistic and said, “When there is a challenge definitely there is an opportunity. And when you take a challenge as an opportunity there is surety that success will follow you.” His presentation gave evidence of his teaching skills at a industry platform.

He said that today's society is a knowledge-driven society and added, “I don't know whether the new government will work in this area but if at all the 10 per cent work is done in the area of intellectual segment of science then certainly India will be on the top of the world as it has a capability of generating intellectuals. Biyani, while speaking about the need for enhancing solubility and permeability enhancements, mentioned that it is most promising that absorption enhancer increases the bioavailability of poorly permeable drugs. The compounds like SLS, bile salts, cyclodextrin, chitosan, fatty acids appears to be of first choice as the permeation enhancers. Some materials/techniques can enhance solubility as well as permeability. Purohit presented his views on hard capsules for dry powder inhalers: performance on puncturing. Purohit clarified that hard gelatin capsules with 0.25 g desiccant can be used safely so as to avoid the soggy capsules in coastal areas. The performance is not affected in arid or semiarid regions. HPMC capsules are found to be most suitable since they are not affected by any change in moisture content. The capsule does not have the tendency to absorb moisture. He suggested that Alu-Alu packs can be evaluated for suitability since they offer best protection against moisture. However, studies need to be conducted on the in vitro performance of the product such as FPF, MMAD and GSD. u.sharma@expressindia.com

EVENT BRIEF JULY 2014- AUGUST 2014 23

Emerging Trends in Drug Discovery: AICADD – 2014

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: Amrita Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference which aims to make a ‘industry-scientists-academics’ collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are

expecting more than 500 delegates including nobel laureates/ scientists/ researchers/ students and professionals from academia and industries from all over the country and abroad. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalised drug design, bioinformatics and biomedical en-

To subscribe: bpd.subscription@expressindia.com

The Indian Pharmaceutical Association Convention – 2014

gineering. Contact details Dr PK Krishnan Namboori Asso. Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug Discovery- AICADD-2014 Computational Chemistry Group (CCG) Computational Engineering and Networking AMRITA Vishwa Vidyapeetham-Amrita University Amritanagar, Coimbatore - 641 112 Tel: (0422) 2685000 (Extn: 5592)

Email: aicadd_2014@cb.amrita.edu / aicadd2014@gmail.com Website: http://www.amritaccg.inConference URL: http://www.amritaccg.in /aicadd2014

THE INDIAN PHARMACEUTICAL ASSOCIATION CONVENTION – 2014 Date: August 9, 2014 Venue: NIMHANS Convention Centre, Bangalore Summary: The Indian Phar-

maceutical Association is celebrating its Platinum Jubliee this year. IPA and IPA-Karnataka State Branch is organising a seminar on 'Excellence in Quality -Applying Learning to Practice'. This seminar is an inauguration of the IPA’s Platinum Jubliee . Celebration. The seminar is planned for regulatory and industry professionals, community pharmacists and hospital pharmacists and academic professionals and students. Contact details www.ipapharma.org

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cover ) 3

1. Aditi Kare-Panandikar 2. Manish Soman 3. Cheryl Pinto 4. Ranjit Shahani 5. Bhasker Iyer 6.Sharad Tyagi

HEALING THE WORLD 22 EXPRESS PHARMA July 16-31, 2014

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7. Paresh Parasnis 8. Biren R Bhuta 9. Dr Vijay Chandru 10. Dheeraj Aggarwal 11. Sameer Savkur 12. Smita Saha

Express Pharmaâ&#x20AC;&#x2122;s CSR Special spotlights initiatives beyond medicines that heal the world

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July 16-31, 2014

cover ) Biogen Idec: Caring deeply B

iogen Idec prides itself in the business of transforming lives of patients. Corporate citizenship is deeply ingrained into the company’s day-to-day business activities and is a cultural imperative across the organisation. The company is the first US-based biotech to be listed on the Dow Jones Sustainability index and has the topmost Carbon Disclosure Score in biotech sector as a part of the ‘Carbon Disclosure Project.’

Caring for the community Sharing his views Sameer Savkur, Managing Director, Biogen Idec says, “CSR is a significant commitment for the business community to take responsibility for. Many issues fall under the umbrella of CSR and companies need to examine what is relevant to them and is achievable. CSR should be viewed as an investment for the company and worked at. After all, the industry does not operate in isolation from the rest of society, particularly since its employees and stakeholders are drawn from the wider community.” In line with its commitment to corporate citizenship, the company has taken the onus of strengthening the communities in and around the locations it operates in. To this tune, Biogen Idec’s ‘Care Deeply Volunteer Day’ was introduced across the company’s largest locations in 2011 and rolled out globally to Biogen Idec offices in 2012. The worldwide project enables employees to participate in meaningful community service projects by giving them a paid day off and increase the role of employee volunteerism with focus on patients, science education and local communities. More than 1,600 employees embarked on Care Deeply Volunteer Day initiatives in 2012, participating in more than 80 projects in 22 countries around the world. In 2013, more than 1,900 employees volunteered in 28 countries

24 EXPRESS PHARMA July 16-31, 2014

around the world on more than 152 individual projects, making this the company’s largest volunteer effort ever. 2014 is trending to exceed the mark with 32 locations participating. Last year employees served approximately over 300 volunteer hours in more than 12 cities across India. In Gurgaon, employees provided prosthetics to a kid suffering from cerebral palsy and organised a green drive at Khusboo Welfare Society, a voluntary non-governmental organisation that works for the development, education and rehabilitation of children and young adults with mental and multiple disabilities. In Chandigarh and Bangalore, employees along with their families engaged with children of Bal Niketan and Angel Orphanage while in Kolkata they counseled kids at St Mary’s Orphanage and guided them on livelihood and career opportunities. This year the company

plans to focus the projects on the philosophy of CEO, C = children, E= environment, O= old age; to make substantial impact for society’s betterment.

Measuring the impact

“CSR is a significant commitment for the business community to take responsibility for. Many issues fall under the umbrella of CSR and companies need to examine what is relevant to them and is achievable” Sameer Savkur, Managing Director, Biogen Idec

Pitches in Savkur, “At Biogen, philanthropy serves as a centerpiece for our global corporate social responsibility efforts. Biogen Idec is in the business of transforming lives of the patients we serve and corporate citizenship is incorporated into day-to-day business activities. Ultimately, our success is measured by the impact on people’s lives and the quality of life associated with that change.” An assessment of the hours of service done by the employees and the number of NGOs involved is an indication of the extent of impact. The company also anecdotally measures the impact on employee’s satisfaction from the project; pride in working for the

company and the staff and people served by the NGOs. Philanthropy serves as a centrepiece of its global corporate social responsibility efforts. In May this year, it partnered with Swedish Orphan Biovitrum AB to donate one billion international units of clotting factor therapy to humanitarian aid programs dedicated to raising the standard of care for people with haemophilia in the developing world over the next 10 years. This is the largest donation of clotting factors in the history of haemophilia, and it will go to people who are in desperate need of treatment. It is anticipated that the initiative will help physicians treat more than 75,000 joint bleeding episodes and 2,000 life-threatening bleeding episodes. According to the World Federation of Haemophilia, approximately 75 per cent of people with haemophilia are undertreated or receive no treatment at all. Because of this severe shortage of therapy, children in developing countries are often unable to walk, play or go to school and many people with haemophilia die before they reach adulthood. Besides community efforts, donating therapy to help patient populations, the company is also dedicated to fostering innovation in healthcare and the life sciences by helping to support future researchers and clinicians from the youngest learners to those making science a career. Towards this, the Biogen Idec Community Lab is the longestrunning, hands-on corporate science lab in the US. A second Community Lab at the company’s RTP site in North Carolina is to come up soon to help inspire more students to become the scientists of tomorrow. The lab exposes middle and high school students to hands-on, real-world science with a fun and interactive approach and has already helped 20,000 students in Greater Boston to experience real laboratory science.

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Boehringer Ingelheim India: Empowering changemakers I

nnovation is intrinsic to human nature but very often, the impact of these remain restricted to a small circle. A transformation is only possible if each innovator receives a helping hand to tide them over the growing pains. Boehringer Ingelheim’s CSR initiative, Making More Health, in partnership with Ashoka, has helped social entrepreneurs across the globe, implement new ideas to improve health in their communities, thus multiplying the impact of these innovations CSR activities are about finding the right balance between a company's business goals and social values and using the former to fund the latter, without comprising on either. Headquartered in Germany, the 129year-old Boehringer Ingelheim started their CSR initiative, Making More Health (MMH) in 2010. Speaking about the ethos behind the MMH and its link with the company’s culture, Sharad Tyagi, Chairman and Managing Director, Boehringer Ingelheim India, says, “Boehringer Ingelheim has a distinctive company culture that fosters innovation, drives high performance and encourages diversity, collaboration and mutual respect. The four values (respect, trust, empathy and passion) characterise the very nature of Boehringer Ingelheim. Together, all employees will further develop Boehringer Ingelheim’s culture, its most distinctive character, at the same time its most important competitive advantage, enabling the company to realise its vision: Value through Innovation. Making More Health is a part of it.” The mission statement of MMH is to find innovative ways to bring more health to individuals, families and communities around the world. Explaining the essence of the initiative, Tyagi,

programmes that identifies and support innovative health solutions.

The entire work is based on three main areas:

says, “Consistent with Boehringer Ingelheim’s “Value through Innovation”, the vision of MMH is to identify new and better ways of improving health globally. Our main objective is to create a social impact in health, which will play a key role for patients and providers now and in the future.” To achieve this goal, BI partnered with Ashoka, a global organisation, that identifies and invests in leading social entrepreneurs. These are people with system changing solutions for the world’s most urgent social problems. Since 1981, Ashoka has selected nearly 3,000 social entrepreneurs as Ashoka Fellows, providing them with living stipends, professional support and access to a global network of peers in more than 70 countries. Through their innovative solutions, Ashoka Fellows help society re-envision what is possible; they inspire, recruit, and enable the world’s citizens to act as changemakers for the most pressing issues of our day. Through this work, Ashoka is building an ‘Everyone A Changemaker’ world. Tyagi adds that BI additionally works with local NGOs and social enterprises in several

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countries - depending on the company’s global and local MMH projects.

Combining business and social values

“The four values (respect, trust, empathy and passion) characterise the very nature of Boehringer Ingelheim. Our main objective is to create a social impact in health, which will play a key role for patients and providers now and in the future” Sharad Tyagi, Chairman and Managing Director, Boehringer Ingelheim India

As a pharmaceutical company, BI knows about the challenges concerning healthcare delivery which exist across countries. And have chosen to make a difference by harnessing a collaborative approach. “We believe that the most pressing problems in health around the world will require new types of collaborations between market-based companies, non-governmental organisations (NGOs) and governments, which will build on their respective fieldbased experience to create new systems to improve health. This is why BI has embarked on a journey with Ashoka to explore the field-based activities of people around the world, known as ‘social entrepreneurs’, who implement new ideas to improve health in their communities. MMH is an initiative where business and social values can be combined to unleash innovation and achieve economic and social progress.”

Scope of MMH The MMH activities include a series of

◆ The continuous election of social entrepreneurs and integration into the MMH Network. Social entrepreneurs solve urgent social problems sustainably and on a large scale, for example, in fields like combating poverty, education, family, integration, human rights and environmental protection ◆ The Youth Venture Programme engages young people in designing healthcare solutions for their communities so that they become changemakers ◆ The Executive in Residence programme where BI employees actively support social entrepreneurs BI in partnership with the Ashoka Foundation, has supported 50 social entrepreneurs (three of them in India) working with the community in the field of health. Across the world, 2200 employees of BI work on these projects in their own time to share their expertise. The Banyan, run by Vandana Gopikumar in Tamil Nadu, uses a community care approach to treat and rehabilitate mentally ill homeless women. Save Life Foundation, headed by Piyush Tewari, is creating a trained netwrk of trauma care first responders in Delhi. Sameer Sawarkar started Neurosynaptic Communciaitons to imporve access to healthcare in rural India through technology and he already has health kiosks running in Bihar and UP and a government hospital in Tamil Nadu. As Tyagi sums up, “The vision of MMH is to identify new and better ways of improving health globally.”

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cover ) Indoco: Remedies beyond prescription T

he Companies Bill 2012 makes it compulsory for the corporate houses to indulge in Corporate Social Responsibility (CSR) activities. However, for some pharma companies charity was a priority even before this bill was passed in the Loksabha. One such pharma company, Indoco Remedies, has been spending a considerable chunk of its profits on different CSR initiatives for last many years. Beneficiaries of Indoco's CSR initiatives could be located across India.

Charity is the policy Indoco’s founder, late Govind Ramnath Kare, strongly believed that every organisation has a social obligation to give back to the society what it has earned from it. Till today Indoco has kept alive and grown with this philosophy. “It was in 1997 that our Chairman, Suresh Kare announced the formation of a one crore corpus to take the cause of social responsibility forward. In the following year, the Suresh Kare-Indoco Foundation (SKIF) was formed through which the company would carry out its social activities. Education, health, school infrastructure in rural areas and upliftment of the economically backward sections of the society are the areas in which Indoco continues to contribute and make a difference,” informs Aditi Kare-Panandikar, Managing Director, Indoco Remedies. Indoco carries out its selffunded CSR activities through the SKIF and sometimes with the help of NGOs. The company was appreciated for its association with The Institute of Psychological Health, based in Thane who does commendable work in creating awareness within the society and providing treatment and support to the mentally ill. Indoco's financial contributions to such an organisation have made them survive, grow and serve the society.

26 EXPRESS PHARMA July 16-31, 2014

A plethora of initiatives The list of Indoco's noble deeds is quite long and includes many philanthropic activities. Kare-Panandikar informs, “Apart from annual donations to the Indian Cancer Society, the company also supports the Nana Palkar Smriti Samiti, an institute that strives for subsidised living and treatment of economically challenged cancer patients.” The company has a soft corner for specially-abled children who require support and assistance to lead normal and full lives. She adds, “Indoco greatly supports this cause and has made significant financial contributions to schools and NGOs working with the specially-abled. Moreover, besides providing free medical aid to various institutes, the company has also provided financial aid to improve hospital facilities and infrastructure in various parts of the country.” Education has remained one of the key focus areas for the company. Scholarships granted for education have helped countless children achieve

“Education, health, school infrastructure in rural areas and upliftment of the economically backward sections of the society are the areas in which Indoco continues to contribute and make a difference” Aditi Kare-Panandikar, Managing Director, Indoco Remedies

their academic goals in India and abroad. Blinds, old age homes, orphanages, women’s institutes have all been benefited some way or other with the donations made by Indoco. Besides well planned charity activities, the company has many times gone out of the way to help needy during uncalled for incidences. Scholarships given to underprivileged children, including to those of the Mumbai bomb blast victims have helped them pursue their education. Travel scholarships have enabled many needy students to pursue further education abroad and achieve respectable positions in the society. Medical aid in the form of medicines distributed at camps has provided the economically backward classes of the society with the support they require to live healthy lives.

Responsible employees It's all in the culture. The recent school kit drive conducted by Seva Sahayog Foundation NGO,

on the company's premises, saw an overwhelming response from the Indocoites, who contributed generously to support students in the slums of Mumbai. Kare-Panandikar says, “The company's efforts have always been towards the upliftment of the economically backward sections of the society. Indoco strongly believes in fulfilling its social responsibility and is proud to be known as a company that significantly contributes to the welfare and betterment of our society. The activities carried out by the company have greatly boosted the morale of its employees who feel privileged to be a part of an organisation that is sensitised to public welfare.”

The way forward For Indoco, charity comes from social responsibility and not compulsion. Kare-Panandikar informs, “An official CSR committee has been recently formed, headed by President -Finance and Company Secretary. Through this committee, the company intends to strengthen its existing efforts in helping the underprivileged and economically backward classes of our society. Support to women, children and the aged in the areas of health, education, public sanitation continue to be the focus areas of our initiative.” Indoco is going to widen its CSR portfolio in future and intends to include environment safety and water conservation related issues on its CSR agenda. “Apart from the existing activities, key areas identified for future CSR initiatives are environmental safety and water conservation. Environment safety is one of the main concerns in today’s world. The company believes it is its responsibility to provide a safe, healthy and pollution-free environment to the society,” concludes KarePanandikar.

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Novartis: Making a difference N

ovartis India is globally known for its quality medicines. The company has managed to save millions of lives across the globe through its innovative drugs. However, Novartis’ tryst with humanity is not limited only to its products. The company understands that it has duties to fulfill which would help in improving social well being. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India, says, “At Novartis, Corporate Social Responsibility (CSR) is a top priority and like everywhere in the corporate world has moved from ‘want to do’ to ‘need to do’. We do everything we can to operate in a manner that is sustainable economically, socially and environmentally and in the best in-

terests of the long-term success of our enterprise. This is a challenging endeavour and a key criterion is to take up projects where we have the ability to make a difference. Hence, the majority of our projects are in the area of health and education.” Novartis is closely involved in several health awareness ini-

tiatives ranging from diabetes to organ donation and age related macular disorders. Novartis also conducts health awareness programmes in rural India through its social business arm Arogya Parivar which began in 2007. Arogya Parivar currently operates in 10 states across India. As far as India is concerned

Novartis’ contribution towards social work is many times more than what the Government is expecting. Nothing needs to be said more about the company which spends billions of dollars for the well being of the society and promises to do so in future as well. Given here is a list of some of the activities the company has undertaken as a part of its CSR initiatives either directly on its own or through funding by its parent company: ◆ Glivec International Patient Assistance Programme (GIPAP): This programme was set up by Novartis in late 2002 to provide access to Glivec to those patients suffering from a particular form of Continued on Page 31

“We do everything we can to operate in a manner that is sustainable economically, socially and environmentally and in the best interests of the long-term success of our enterprise” Ranjit Shahani, Vice Chairman and Managing Director, Novartis India

cover ) Abbott India: Fostering humanity A

public listed pharmaceutical company, Abbott India is a part of Abbott’s global pharma business in India. The company believes that an innovative, responsible and sustainable business plays an important role in building a healthy, thriving society — in India and around the world. Reliving the company’s coveted efforts, Bhasker Iyer, Divisional Vice President and Head, Abbott India says, “We strive to foster economic, environmental and social well-being as we pursue the work of discovering, developing, manufacturing and distributing products that enhance people’s health. In India, our strategic approach to responsible and inclusive business is informed by the country’s unique challenges and opportunities to improve lives.”

Holistic approach Abbott works with partners such as local governments, healthcare providers, nonprofit organisations, associations and consumer groups to serve current healthcare needs, while shaping new methods of care and improving treatment and nutrition standards to bridge existing healthcare gaps in India. The day is not very far when India will become the world’s diabetes capital. Today’s fast moving lifestyle has resulted the rampant growth in diabetes affected patients in India. And to work on the area, the company has already initiated under the Abbott’s Foundation, the Abbott Fund, which is providing a $2 million grant to the International Diabetes Federation (IDF) to conduct a four-year pilot project in Chennai to address gestational diabetes mellitus (GDM), a significant issue of maternal and child health in India, affecting more than five million women. Highlighting

28 EXPRESS PHARMA July 16-31, 2014

the importance of the projects Iyer says, “Working with the leading diabetes stakeholders, the project will develop a new model of care approach for women with GDM through the establishment of new treatment management guidelines to provide high-quality care in resource-limited settings. The potential reach of this initiative is significant; once finalised, the IDF plans to introduce the guidelines in countries around the world to improve the treatment of GDM globally.” The company’s diabetes continuum of care takes a holistic approach that covers awareness, diagnostics, treatment, monitoring and compliance. “This is delivered both through our core business, working together with the government to train health workers on

“We strive to foster economic, environmental and social well-being as we pursue the work of discovering, developing, manufacturing and distributing products that enhance people’s health” Bhasker Iyer, Divisional Vice President and Head, Abbott India

diabetes prevention and management, and in partnership with leading foundations and organisations,” adds Iyer. Beside these, Abbott has also partnered with Operation Asha to combat TB/diabetes co-infection. Informing about the programme, Iyer elaborates, “Building on Operation Asha’s existing programmes that bring TB prevention, testing and treatment right to the doorstep of hard-to-reach urban populations, Abbott is supporting a pilot initiative in Delhi that aims to raise awareness of TB/diabetes co-infection, and seek to uncover the best ways to diagnose and manage co-infection. The partnership aims to share learnings globally, potentially helping to address co-infection in countries where TB burden is high and chronic diseases like diabetes are on the rise.” Beyond diabetes,

Abbott has several initiatives designed to address other critical issues in India. Speaking about them, Iyer informs, “Abbott Nutrition reaches out to mothers of school-going children through its SureMoms initiative, which was launched in 2012, educating them about the importance of complete, balanced nutrition. The objective is to interactively enhance knowledge on the issue of fussy eating for children in the age-group of two to 10 years. The initiative has reached out to 25,000 mothers and more than 200 schools across the country.” The initiative has engaged around 20,000 more mothers over the last year. This year, we plan to reach 45,000 mothers covering 10 Indian cities.” Besides these, the Government of Puducherry and Abbott have signed a three-year agreement to improve awareness of non-communicable diseases (NCDs) like diabetes, hypertension and dyslipidaemia (cholesterol related disorders) and thyroid disorders; and implement initiatives to fight them and record their prevalence in the Union Territory (UT) of Puducherry. This approach is expected to impact health outcomes of nearly 700,000 people above the age of 30 years in the UT.

Leveraging scientific expertise Abbott nutrition scientists are working with PATH to improve its Ultra Rice fortification technology in ways that reduce costs while improving nutritional value, ease of manufacturing, stability and taste. Through the public sector programmes alone, the Indian government provides approximately 30 million metric tonnes of rice to an estimated 450 million consumers – which points to the potentially far-reaching impact of Ultra

( Rice in India. In addition, because fortified rice will be produced by local businesses and rice millers, the programme will build and empower local capacity and strengthen local distribution chains. Iyer illuminates, “Enhancing a daily staple with nutrients so that it still looks, cooks and tastes like rice – and keeping it affordable – is a considerable challenge. By combining the nutrition expertise of Abbott and PATH, the partnership aims to introduce new formulations of Ultra Rice that will effectively deliver nutrients to help address malnutrition.” The enhanced Ultra Rice technology developed by PATH and Abbott nutrition scientists, product developers and food engineers holds great potential to reduce malnutrition in many other countries where malnutrition is high and rice is a staple food. PATH and Abbott’s foundation, the Abbott Fund, are also working to build local production capacity, expand distribution of fortified rice in India’s public and private sectors, and develop low-cost quality assurance tools to ensure production of high-quality fortified rice. Abbott Fund has provided a three-year, $1.5 million grant for refining and scaling up the production and distribution of fortified rice using PATH’s Ultra Rice fortification technology.

combat a wide range of diseases, expanding access to medicines that are critical to addressing maternal and child health and treatment of infections and childhood illnesses like malnutrition and dehydration.

◆ Rooting for sustainability Summing up, Iyer states, “Our citizenship efforts are aligned with our business strategy. By working to deliver innovative new approaches to addressing critical healthcare and social

challenges in India and around the world, we can sustainably realise our potential by helping others realise theirs. Through responsible business and citizenship activities, we also engage with society more effectively, and

◆ Product donations Since 2005, Abbott has distributed more than $5.2 million worth of nutritional and pharma products to India. These donations have helped

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build a more inclusive business that reaches more people, in more places, than ever before. This helps us find new opportunities to expand the positive impact of our people, products and business in communities across India.”

Ready-to-Sterilize Components

Ready-to-Sterilize Packaging and Syringe Components

Humanitarian initiatives ◆ Disaster relief In 2013, Abbott provided nearly $20,000 worth of product donations to respond to Cyclone Phailin, which hit the coastal areas of Odisha and Andhra Pradesh in India. Abbott products were distributed through AmeriCares’ network of response partners in the region.

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cover ) Strand Life Sciences: Bettering lives W

ith an aim to provide better healthcare access at affordable cost to all people living in the Indian society, Strand Life Sciences tries to live upto its commitments and has shouldered its share of social responsibility through its Stand Life Foundation.

untarily participate in all CSR activities undertaken by the company.

Strand Life Foundation Dr Vijay Chandru, Chairman and Chief Executive, Strand Life Sciences informs that the Strand Life Foundation is a notfor-profit enterprise established by Strand Life Sciences in 2014 with the vision to: ◆ Make genomic-based diagnostics affordable and accessible to populations in India and other economies in need of these services. The Strand Life Foundation intends to achieve this ambition through funding of programmes such as R&D for cost optimisation, direct payments to patients or to healthcare providers and related service providers to alleviate the financial burden on patients, and advancement of the state of knowledge and science in the field of genetics and clinical genomics. ◆ Change in the current scenario, by enhancing the focus on personalised medicine, and women and child health. ◆ Conservation of ecological biodiversity.

Its various CSR initiatives comprise: ◆ Social partnerships - Personalised medicine As a major milestone towards enabling an ecosystem of personalised medical treatment for patients with cancer and other genetic diseases, Strand Life Sciences has received a grant from the Mazumdar-Shaw Medical Foundation to set up a translational research laboratory in India for genomics and personalised medicine. ◆ Women and child health Informing about the work car-

30 EXPRESS PHARMA July 16-31, 2014

ried for women and children in the healthcare domain, Chandru highlights that Strand Life Foundation seeks to contribute by bridging gaps in health (including preventive, nutritional and mental health) needs of women and children by promoting programmes and activities that steer them towards healthier living and empower them to opt for a better quality of life. Rising numbers of cancer related deaths is a serious cause of concern in India. If we calculate the data available in the public domain in the last three or years, the total number of deaths related to cancer has already grown multi-fold. Stand Life Sciences is working to create public awareness in this area through various programmes. Chandru informs, “In our efforts to highlight the need for increased awareness about breast cancer, The Strand Centre supported the 2014, Bangalore Pinkathon, which is an international all women's run. Also, as a part of the public initiative

and support towards the Pinkathon, a social media page called GENOMICS and WOMEN has been set up by Strand to keep women abreast about the importance of genomics in various diseases.”

“Strand Life Foundation seeks to contribute by bridging gaps in health (including preventive, nutritional and mental health) needs of women and children by promoting programmes and activities that steer them towards healthier living and empower them to opt for a better quality of life” Dr Vijay Chandru, Chairman and Chief Executive, Strand Life Sciences

◆ Child education Better educated and informed children are the future of Indian economy hence the company has chosen to associate itself with child education programmes. Chandru elaborates on these initiatives and says, “The Strand Life Foundation actively participates in organising educational programmes for underprivileged elementary and high school students in rural Bangalore and surrounding areas. Recently, we participated in an innovation, science and technology fair organised by the Ankurit Foundation to imbibe children between ages 5 and 17 with curiosity and love for science. The science fair attracted more than 2000 students from across different government and private schools in Bangalore.” Strand employees enthusiastically and vol-

◆ Environment and Biodiversity Conservation Realising to its duty and responsibilities towards nature, the Strand Foundation has also opted to work in this area. Recalling his company's philosophy and responsibilities, Chandru emphasises, “The Strand Life Foundation takes its environmental responsibility seriously and endeavours to promote the protection of ecological biodiversity by funding programmes such as cataloguing of biodiversity, and R&D to develop relevant tools and methods.” The India Biodiversity Portal (IBP) is Strand's contribution to help biodiversity conservation in India. IBP is designed to harness collective knowledge on biodiversity; aggregate information and provide free and open access to biodiversity information. IBP was launched in 2008 and supported by a group of likeminded institutions and endorsed by the National Knowledge Commission to support open data in biodiversity. Strand is the technology partner in building this enabling platform to crowd source, curate, and aggregate biodiversity information. The platform has matured and now consists of a fully featured web GIS module; a standards compliant species pages module; a document and open data module; and a citizen science observation module. This integrated open source, Biodiversity Informatics Platform powers the Bhutan Biodiversity Portal (BBP), the Weed Identification and Knowledge in the Western Indian Ocean (WIKWIO), the India Biodiversity Portal (IBP), and the Western Ghats Portal (WGP). The Western Ghats Biodiversity Portal was funded by Conservation International, USA as part of the Critical Ecosystem Partnership Fund (CEPF).

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Novartis: Making a... chronic myeloid leukaemia and gastrointestinal stromal tumours who could not afford the drug and were not reimbursed. GIPAP is administered by the Max Foundation, a non-profit organisation. More than 95 per cent of patients who are on Glivec in India receive the drug totally free of any charge while the balance are on a generous co-pay programme. Patients on GIPAP come from all over the country including the NorthEast. Currently, there are around 17,000 patients who are on GIPAP and receive Glivec completely free of charge. Since its inception in 2002, the company has distributed Glivec valued at more than $1.7 billion absolutely free of charge to patients enrolled under GIPAP. ◆ Novartis Comprehensive Leprosy Care Association (formerly known as Comprehensive Leprosy Care Project - CLCP): It was set up by the Novartis Foundation for sustainable development in 1989 provides patients access to treatment and disability management and facilitates physical and social care. Novartis is committed to eliminating leprosy from the world through its donation to WHO of Multidrug therapy (MDT) required to treat leprosy. Almost the entire global need of leprosy drugs is met through this donation by Novartis AG. India, with over 60 per cent of the world’s cases of leprosy, is the largest beneficiary of these drugs. In addition, the company is firm of the belief that people who are afflicted with leprosy need to be rehabilitated so that they can earn a living particularly in view of the stigma associated with the disease. The programme has covered states of Goa, Maharashtra, Gujarat and Madhya Pradesh and has benefited around 17,000 patients so far. ◆ The Indian School of Business scholarship: A yearly scholarship of ` 12 lakhs is divided among three needy women students with excellent academic credentials coming

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from middle class backgrounds. Novartis has been doing this for the last ten years. Further extensions will be considered at the end of the current

five-year period. ◆ Akanksha: Novartis has participated in the Standard Chartered marathon held since 2004 with a commitment that the

amount donated goes to Akanksha for the education and health of underprivileged children. Employees are encouraged to volunteer time at this centre. For two

years employees were involved in a mentor programme which helped raise satisfaction among employees who served as mentors.

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July 16-31, 2014 Glatt. Integrated Process Solutions.

cover ) Sciformix: Promoting volunteering S

ciformix Corporation is a Scientific Process Organization (SPO), providing scientific knowledgebased services to pharmaceutical and biopharmaceutical, generics, consumer products, medical devices and other healthcare companies. Working in the areas of safety and risk management, clinical research ,postapproval support and regulatory affairs, the company has taken it up as its mission to help people live healthier lives.

Employees’ day out In 2013, on its founding day, May 7, the company introduced its Social Impact Initiative (SII) day. The day is marked by employees across its offices in India and Phillipines leaving their offices and volunteering their time to charities that care for orphans, destitute women and the elderly. The focus is to work at the grassroots of local communities, providing medical provision and expertise to those who need it most. Funded entirely by the company, the programme aims to expand in other geographies over time. Echoes Manish Soman, CEO, Sciformix Corporation, “Volunteering is one of the ways in which we feel we can give something back to our local communities and respond to their needs. We have to remember that success is defined not only by business achievements, but also by how well we serve our communities and enrich our ecosystem.” Many of the orphans the company cares for as part of SII are HIV positive, and are urgently in need of the immediate healthcare. This year over 500 employees carried out substantial work across 24 local charities in Pune, Mumbai and Manila. The teams of volunteers set

32 EXPRESS PHARMA July 16-31, 2014

“Volunteering is one of the ways in which we feel we can give something back to our local communities and respond to their needs” Manish Soman, CEO, Sciformix Corporation

up medical camps, delivered healthcare provision to those with immediate requirements and staged health awareness presentations for healthcare educational purposes. The charities served include Tunga Gaon Charitable Trust, Mumbai, where qualified medical practitioner employees dispensed essential but often life saving medicines from the medical camp. In Pune, Sciformix teams support Akanksha, a school for underprivileged children. Further visits were undertaken this year in Manila, The Philippines, to Tahanan Ng Pagmamahal Children’s Home and Kanlungan Ni Maria Home for the Aged. Additional teams spent time visiting people of all ages including underpriviledged children and the elderly across various charities including Ekalavya Bal Shikshan & Arogya Nyasa, St John’s Home, and Kinara Vridha and Matimanda Seva

( Trust.” The staff also spent time with the people we set out to help – the importance of social interaction can often be overlooked. By working with so many charities, our staff were able to impact the lives of thousands of orphans, destitute women and the elderly. When hundreds of people decide to make a difference, anything is possible,” says Soman.

A suitable connect Soman feels that volunteering as a CSR activity through the SII programme sits perfect with within the company mission of helping people live healthier lives. “It allows us to fully realise our company values of integrity, commitment, focus, innovation, diversity, excellence and teamwork every day, in everything we do. Giving, volunteering and the development of business innovations are the ways in which we live our mission and respond to the needs of our communities. Each is equally important, and together they become a powerful commitment to improving health, people’s lives and the communities in which we work and live,” he adds. The company believes in improving patient care around the world, therefore, making it a safer place. Also since it operates globally, many of the employees working in Pune, Mumbai and Manila do not see patients on a daily basis. Thus the opportunity to deliver healthcare provision through the SII programme not only allows vital aid for those local charities, but allows employees to live, breath and achieve company mission. In its second year, the SII programme, is still very much in its infancy. As Sciformix continues to grow, it is likely that the SII programme will evolve and grow together with the company. However, the focus of the programme will not be lost. Focus will always lie in helping charities in local communities, specifically those charities that work with or-

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July 16-31, 2014

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phans, destitute women and the elderly. “We would like to increase focus on CSR programmes where we can add more value by using our knowledge of pharma products and our medical backgrounds even more,” he concludes.

cover ) Piramal Group: Caring for all P

iramal Foundation runs initiatives that all contribute in nation building. Its focus areas are health, education, youth empowerment and livelihoods. Piramal Foundation is the CSR arm of the Piramal Group and runs these initiatives. The group also believes in partnerships and on project basis they partner with Governments, corporate and other foundations as well. Paresh Parasnis, Head- Piramal Foundation, says, “Piramal Foundation strongly believes that there are untapped innovative solutions that can address India’s most pressing problems. Each social project that is chosen to be funded and nurtured by the Piramal Foundation lies within one of the four broad areas -healthcare, education, livelihood creation and youth empowerment. The Foundation believes in developing innovative solutions to issues that are critical roadblocks towards unlocking India’s economic potential.”

CSR initiatives of Piramal Foundation: ◆ Piramal Swasthya: It is a unique model that is built on the backbone of telecom. A healthcare helpline supported by clinical expertise (servicing over 26 million callers across six states), mobile health units (providing access to primary healthcare to remote villages) and telemedicine centres servicing remote tribal locations by linking to specialists are services offered through this initiative. Piramal Swasthya works in partnership with state governments under the NRHM and has, so far, serviced 40 million patients in seven states over the last six years and saved 250,000 doctor days. ◆ Piramal Sarvajal: It is engaged in alleviating issues around access to safe drinking water which has led to a large incidence of water borne diseases and consequent loss of 73 million working days. Sarvajal

34 EXPRESS PHARMA July 16-31, 2014

is a social enterprise implementing an innovative and technology-centric solution for decentralised filtration and distribution. Working with rural entrepreneurs, Sarvajal is creating a self sustaining solution which uses remote sensing, solar power and RFID technology to ensure quality, transparency and accountability. Sarvajal currently serves 1,20,000 people daily and has been a key partner working with Delhi Jal Board. ◆ Piramal Foundation for Education Leadership (PFEL): It aims to build a world class university for education in Rajasthan. PFEL is currently focused on creating leadership capacity in government schools. The Principal Leadership Development Programme works with headmasters in 1,200 government schools in Rajasthan, Surat and Mumbai covering about 1,50,000 children. This is a three year part time programme for head masters covering four aspects of leadership. The programme is

“Piramal Foundation strongly believes that there are untapped innovative solutions that can address India’s most pressing problems. Each social project that is chosen to be funded and nurtured by the Piramal Foundation lies within one of the four broad areas – healthcare, education, livelihood creation and youth empowerment” Paresh Parasnis, Head, Piramal Foundation

implemented through Piramal fellows, young graduates who have the urge to contribute to grass root change in society. Creating socially conscious leaders who can contribute to the nation building effort is the focus on the fellowship. The foundation has recently set up a Piramal School of Leadership, a 44,000 sq ft facility in Bagar, Jhunjhunu in Rajasthan, combining the best of technology and open design principles to foster group learning. The School of Leadership will, over the next couple of years, offer accredited courses for young students keen on actively addressing specific issues in the development sector. ◆ Piramal Udgam: It is a rural BPO which provides employment opportunities for women in rural areas around Jhunjhunu. Over 400 women and men have worked, learned and earned a dignified living through this centre. The centre empowers them with an employable skill set which helps build their confidence whereas the money earned is invested

back in the family, particularly encouraging their children’s education. ◆ Gopikrishna Piramal Memorial Hospital: It was established in 1983, to focus on major issues of delivery of child healthcare and welfare to the underprivileged segment of the society. Free medical services are offered on out-patient basis like extended immunisation programme, medical check-up camps, paediatric consultation, camps for detection of diabetes and hypertension in economically socially backward areas along with free medicines, DOT programme in collaboration with BMC, DGHS and WHO. The hospital also provides nephrology consultation and haemodialysis therapy service for patients with end stage renal disease with nominal charges. ◆ Pratham: It was established in 1994 to provide pre-school education to the children in the slums of Mumbai city, now the largest NGO working to provide quality education to the underprivileged children of India. Ajay Piramal is the current Chairman of Pratham. Pratham launched the Read India campaign, currently implemented in 350 districts across 19 states in the country, reaching 33 million children. More than 450,000 volunteers have been mobilised and 600,000 teachers and government officials have been trained in accelerated learning methodologies developed by Pratham. Piramal Foundation's CSR initiatives span across many fields. Schemes like Piramal Sarvajal hold a lot of importance in a country like India where water scarcity is a major issue. Foundation's work in health and education sector is also widely appreciated. If other companies would also decide to follow the the footsteps of Piramal Foundation, many social issues that Government couldn't address can be resolved.

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Glenmark Pharma: Creating a healthier and happier world H

ealthcare experts have constantly raised questions over the standards of child healthcare in India. Being an important stakeholder in the process of maintaining the health of Indian and global population, Glenmark Pharmaceuticals, aptly selected child healthcare as its prime CSR domain.

Caring for child “Our CSR vision is to enrich lives to create a healthier and happier world. Glenmark Foundation, the CSR arm of Glenmark Pharmaceuticals, has been actively engaged in strategising, implementing and creating social impact through our two core areas which are child health and sustainable livelihoods. Our flagship initiative, which is in the area of child health is focused on children up to the age of five and pregnant mothers. A few years ago we had undertaken detailed research in the field of child health. The important findings of the research directed us to initiate Project ‘Kavach’. The word ‘Kavach’ means a shield; symbolising protection,” informs Cheryl Pinto, Director, Corporate Affairs, Glenmark Pharmaceuticals.

How ‘Kavach’ works Glenmark’s programmes aim at providing health education and awareness to mothers and caregivers; with a focus on reducing malnutrition, ensuring complete immunisation for children between the ages 0–5 years, and improving hygiene and sanitary practices. Through project Kavach initiative, the company has provided ambulatory care to the remotest forest based villages, which do not have ac-

“Our CSR vision is to enrich lives to create a healthier and happier world” Cheryl Pinto, Director Corporate Affairs

cessibility to proper healthcare. It runs five days a week to attend to the children with severe acute malnourishment (SAM) condition who are identified and referred to the nutritional rehabilitation centre. “The company has successfully recovered over 5000 severely acute malnourished (SAM) children to healthy status. We were successful in transforming anganwadis (day-care centres) to role model anganwadis making them child friendly, thus ensuring maximum attendance and tracking services such as supplementary nutrition and immunisation. In order to track immunisation customised calendars are distributed to the local panchayat members, anganwadi workers and helpers. Regular health camps are organised with the local healthcare departments. We have

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July 16-31, 2014

cover ) Tata Steel: Improving lives I

t is very usual to see companies working in the healthcare industry doing CSR activities. However, there are companies from other industries as well that are equally concerned about the health of the Indian population. Tata Steel is the world’s leading steel manufacturing company which has launched activities like maternal and newborn survival initiative, Sparsh etc. Biren R Bhuta, Chief, CSR, Tata Steel informs, “Project MANSI was born of the need to reduce maternal and child mortality and morbidity in Seraikela block of SeraikelaKharaswan district in Jharkhand. MANSI has covered 167 villages in this district, the population covered was around 83,000 between the year 2009 and 2013. Training workshops for nearly 196 Sahiyas were conducted on home based maternal, newborn and child care.” He adds, “Focused interventions over the last four years have led to significant results. Child mortality has come down from 67 to 50. Infant mortality rate has come down from 54 to 39. Percentage of deliveries at home decreased by 45 per cent. Percentage of low birth weight has decreased from 21 per cent to 15 per cent.”

Outcomes of CSR Tata Steel’s CSR initiatives have shown promising changes among the target population. Deliveries at home decreased by 45 per cent, child mortality rate has decreased by 26.5 per cent, infant mortality has decreased by 26.5 per cent while neo-natal deaths has decreased by 32 per cent. There is increased health awareness and demand for healthcare services among the communities in the project area as MANSI front-line workers along with Sahiyas

36 EXPRESS PHARMA July 16-31, 2014

conduct various village and panchayat level meetings and involve different stakeholders (community based operating partners, Mahila Mandal, Village Health Sanitation and Nutrition Committee) in the meetings.

And the award goes to... ◆ Tata Steel was awarded the Sustainability Prize in Category A for Large Independent Company at the CII-ITC Sustainability Awards 2012 and 2013. In fact, the jury of the Deming Prize cited the MANSI project as (one of the) top five things that TATA steel does, and (asserted) that it could be a model for India and rest of the world. They are quite impressed with the project, the approach to implementing, the processes that it has followed, and the impacts and results in the

last few years.

Tata steel-an agent of change

“Tata Steel has successfully changed life of the population and empowering them to an independent life socially and economically. Tata Steel is committed to engage in activities for community and social welfare and will continue to serve the society at large. The services are focused on improving the lives of people by investing in health, education, skill development, sports and ethnicity,” informs Bhuta. The company says the present programmes will continue and they will also continue to add more programmes which will help them sustain its culture of serving the society.

Biren R Bhuta, Chief CSR, Tata Steel

Key CSR initiatives ◆ SPARSH (the healing touch): Referral

Centre, a joint initiative of Tata Steel Rural Development Society (TSRDS) and LEPRA Society to cater to the needs of people affected with leprosy and lymphatic filariasis, was initiated in 2009, as there were high incidences particularly among those residing in the vicinity of the coal mines of Dhanbad, Jharkhand. The mission of LEPRA India and Tata Steel to serve humanity better led to the establishment of SPARSH with an aim to 'Improve the quality of life of people, particularly those having disabilities, by improving their health'. The disability care centre at Jharia in Dhanbad district of Jharkhand provides OPD treatment along with physiotherapy, self-care training and counseling, information dissemination to reduce stigma, manufacture and distribution of protective footwear etc to the people suffering from leprosy and lymphatic filariasis. ◆ Project MANSI (the Maternal and Newborn Survival Initiative): Issue of maternal and child mortality is a global concern being addressed through the UN Millennium Development Goals (MDG 4 & 5). While India is committed to the MDGs, Human Development Index is poor. India ranks 136 out of 186 countries globally. Life expectancy at birth being a component of HDI, maternal and child survival is a major issue. Jharkhand, one of the states in which Tata Steel operates, ranks 23rd out of 35 Indian states, on infant mortality. Since 2009, MANSI, a public-private initiative, is being implemented by Tata Steel Rural Development Society in partnership with American India Foundation and the Department of Health and Family Welfare, Government of Jharkhand.

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Glenmark Pharmaceuticals...

engaged in various behaviour change communication like wall comic poster, focussed group discussions, role plays and street plays to promote positive health seeking behaviour,” says Pinto.

tion of its employees. Over 3200 Glenmarkians across the globe have volunteered more than 12,800 hours in various community endeavours since its inception in 2010.

Positive impact

Active support from NGOs

Over a span of few years through child health projects the company has been able to positively impact over 100 ethnic tribal villages in rural Khandwa, Madhya Pradesh; 150 rural villages of Sanganer, Rajasthan; 2000 households in the slums of Mumbai, Maharashtra; 1,50,000 rural lives in Solan, Himachal Pradesh and 10,700 households of Kibera slums in Nairobi, Kenya. Pinto says, “It is very important to examine the impact of the endeavours being carried out by us. To regularly evaluate the progress of the projects the focus is on both the quantitative and qualitative impact on the communities supported and the society at large. This is gauged by impact assessments conducted periodically for all the projects. Additionally, impact assessments are conducted by an external agency to review the projects to further strengthen the implementation and outcome of the initiatives.” She adds, “Our Sustainable Livelihoods Programme aims at creating opportunities for school drop outs by providing vocational training, ensuring food security for tribal farmers and helps the disabled regain mobility and dignity through artificial limbs. We have made a difference to over 65,00 lives with our sustainable livelihood initiatives.” Glenmark’s CSR efforts are supplemented further through the coopera-

In order to maximise the scope and impact of programmes, the company works very closely with various nongovernmental organisation (NGO) partners as well as existing government health mission programmes. The projects are currently solely being funded by Glenmark Foundation. NGO partners for the child health interventions are Niramaya Health Foundation and Armman - Mumbai, Maharashtra, Spandan Samaj Sewa Samiti Khandwa, Madhya Pradesh, Society for Integrated Development Action Research and Training (SIDART)-Jaipur, Rajasthan, Institute for Global Development Baddi and Nalagarh, Himachal Pradesh and Carolina for Kibera Nairobi, Kenya. Partners for the Sustainable Livelihood Projects are carried out in PRADAN- Rayagada, Odisha, Bhagwan Mahaveer Viklang Sahayata Samiti -Jaipur, Rajasthan and Kherwari Social Welfare Association -Nashik, Maharashtra

DOP/PAO Leak Testing Air Flow Pattern (Smoke)Test

Accolades for Glenmark Glenmark was ranked among India’s 50 most caring companies by the World CSR Congress, 2013. “Going forward, we will focus on testing innovative solutions for creating greater efficiencies and impact; thus reaching out to maximum population with minimum resources,” signs off Pinto.

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July 16-31, 2014

cover ) Venus: Building healthy societies A

t Venus Remedies, corporate social responsibility is not a modular addon to the business; it is core to the business itself. The company encourages its employees to create an environment-friendly work culture within the company’s campus. The company’s three manufacturing units are in Panchkula and Baddi in India and Werne in Germany. Its research and development centre, Venus Medicine Research Centre (VMRC) which is certified with GLP accreditation and approved by the Department of Scientific and Industrial Research, Government of India (DSIR), is located in Baddi. The company has established various trusts and programmes which are working for various causes including environment preservation. Dheeraj Aggarwal, CFO, Venus Remedies informs, “We are actively involved in tree plantation drives. Our association of employees, Venus Army, undertakes tree plantation drives in various medical institutions across North India. We encourage our employees and visitors to plant as many trees as possible. Venus promotes health, safety and environment as integral part of its business. We strive to prevent the environmental impact of our activities and products. We maintain a safe workplace environment for our employees, visitors and local community. We train our employees to enable them to contribute to a safer environment in their workplace, home and neighbourhood. The landscaped environs at our manufacturing facility, interspersed with gardens of shrubs and decorative plants, shows how environmentally conscious we are.” He continues, “We plan to intensify our campaign to generate more awareness on environmental and health issues, including the importance of tree plantation drives, hygiene and cleanliness.”

38 EXPRESS PHARMA July 16-31, 2014

The company is involved in several programmes under CSR activities, like Manav Uthan Yojana, health camps and environmental and health awareness campaigns. They also conduct free diabetes detection camps in association with the Indian Medical Association, Lions Clubs and Rotary Clubs as well as organise blood donation camps every year. Aggarwal emphasises, “At Venus, corporate social responsibility is not an addon to the business, but is the core of the business itself. In the past four years, over 400 persons have donated blood in the camps conducted by us. We also run a charitable trust which provides free

“We are actively involved in tree plantation drives. Our association of employees, Venus Army, undertakes tree plantation drives in various medical institutions across North India” Dheeraj Aggarwal, CFO, Venus Remedies

healthcare to needy patients.” The company has established a charitable trust named Hanuman Chaudhary Charitable Trust and Manav Uthan Yojana which requisite employees to become part of the initiative and work for the betterment of society. Aggarwal enlightens, “The company runs the Hanuman Chaudhary Charitable Trust, to which all Venus employees contribute 0.75 per cent of their salaries. These funds are spent on providing healthcare to the underprivileged. Under the Manav Uthan Yojana, all Venus Remedies employees contribute a part of their salaries to support

weaker sections of the society. The funds collected from them are utilised for providing beds, cycles, sewing machines and blankets to the poor every year. While all our staff members are entitled to medical facilities, we also extend aid for the education of our workers’ wards.” Venus Remedies also contributes towards the Laxmi Devi Charitable Hospital in Sirsa which provides free primary healthcare, medical consultation and medicines to about 20,000 patients annually. Venus also conducts campaigns to create awareness about the ill-effects associated with tobacco consumption and the misuse of antibiotics. It also publishes a magazine about cancer for the benefit of the oncologist fraternity and patients. Another magazine brought out by the company’s internal team, “Dost”, educates the medical fraternity and patients about the latest health trends and studies, These initiatives have definitely helped us in enhancing our image as a responsible corporate citizen with a social conscience. “We have been involved in environmental awareness campaigns and health camps, where we make more and more people aware of life-threatening diseases like cancer. We publish a magazine on cancer called “Can-survive” to create awareness on the do's and don’ts of chemotherapy,” claims |Aggarwal.

Self reliable Venus Remedies are funding all these projects. Moreover, the company has also launched an antibiotic campaign supported by Venus Medicine Research Centre (VMRC) through the NGO called Emerging Antimicrobial Resistance Society (EARS). It has associated itself with a network of doctors, hospitals, pharmacists and contract research organisations across Continued on Page 40

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AstraZeneca India: For youth empowerment A

straZeneca India, established in 1979 and head-quartered at Bengaluru, Karnataka believes in improving health which is one of the toughest challenges faced by the world today. To accomplish its mission, the company has established Young Health Programme (YHP) in November 2010. It aims to make a meaningful difference to the health and well being of adolescent boys and girls from five marginalised areas of Delhi, known as resettlement colonies. With an intention to serve the entire society on a single platform, it has established AstraZeneca’s global community investment, a partnership between AstraZeneca, Johns Hopkins School of Public Health and Plan International. Informing about the company's objectives, Smita Saha, Vice President – HR, AstraZeneca Pharma India Limited (AZPIL) says, “YHP aims to positively impact the health of adolescents in marginalised communities worldwide through research and evidence generation, advocacy and on-the-ground programmes which are focused on non-communicable disease (NCD) prevention.” With a focus on NCD prevention, YHP globally is enabling AstraZeneca to provide a life course approach to NCD prevention and control. The venture is helping to enhance the company's brand and reputation among key internal and external stakeholders. “It demonstrates our ability to work with partners as well as to design and implement locally-tailored, crosssector approaches,” Saha informs. Employees of the company across the globe are engaged with YHP. In India, employees have made visits to the communities and increased their understanding of the health issues faced by young people in these communities - Mangolpuri, Holambi Kalan and Badarpur respectively.

“YHP aims to positively impact the health of adolescents in marginalised communities worldwide through research, advocacy and programmes which are focused on NCD prevention” Smita Saha, AstraZeneca Pharma India Limited

Saha asserts, “YHP India will continue to work in the five communities in Delhi, developing the programme and ensuring the activities are sustainable. The YHP India, in four to five years, will continue to contribute towards the same goals i.e. building capacity of adolescent girls and boys who take positive action on their own health, raising wider community awareness of key adolescent health issues, improving access to youth friendly services, and addressing immediate needs in relation to water, sanitation and hygiene.”

Growing steadily YHP India is funded by AstraZeneca and delivered by Plan India, working with community partners, Navshriti (Holambi Kalan), CASP (Badarpur and

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AstraZeneca India...

Venus: Building...

Mandanpur Khadar), Dr A V Baliga Trust (Mangolpuri) and Alamb (Dwarka). In India, the programme has been running for the past three years in five project sites (Badarpur, Madanpur Khadar, Mangolpuri, Holambi Kalan and Dwarka), which cover three districts of Delhi. It works with young people aged 10-24 years old and focuses on hygiene and sanitation, sexual reproductive health and wider health issues such as tobacco use and abuse of alcohol. In collaboration with local government and NGO partners, over three years the programme has to date benefited over 114493 young people and reached over 129187 wider community members including parents, health and educational professionals and policy makers. We have trained close to 1800 peer educators who are taking this message forward to their peers and community people. Saha outlines, “We know the output and impact of the programme on society. E.g. Since the YHP India programme was launched, it has reached over 77,000 young people directly, 15 Health Information Centres (HIC) which have been set up serve as a forum to bring young people together to learn discuss and take action on key adolescent health issues.” In 2011, the YHP partnership made a Clinton Global Initiative Commitment to Action to tackle NCDs in young people, and meet a target of reaching 250,000 young people directly and 250,000 indirectly by the end of 2015. It has also started another programme called 'on the ground programme', YHP 'on the ground programmes' are now running in 20 countries across five continents and have directly reached over 485,000 young people aged 10-24 and two million wider population.

New aim to achieve The success of project revolves around the commitment which mainly comes from people engagements and deep understanding of issues. YHP has

40 EXPRESS PHARMA July 16-31, 2014

Information is disseminated to the over 77,000 wider community through various mediums such as street plays, magic shows, workshops, community meetings, video shows, competitions, thematic camps and fairs. Training of 295 government health professionals including Anganwadi workers (family health), ASHA workers (community health) and Auxiliary Nurse Midwives (ANMs) have been a part of YHP’s achievements as well. Briefing about the programme, Saha mentions, “A mid-term evaluation of the programme has just been undertaken, with results expected in mid-July. The YHP India aims to reach further 25,000 young people aged 10-24 (including 15,000 girls) directly through project interventions.”

Meeting the challenges

formed HIC committees which are made up of parents, young people and local leaders who meet to discuss local health issues. “To ensure the sustainability of the resource, these committees will in future take increasing responsibility for the running of the HIC. 1,581 peer educators (PE) trained by YHP are responsible for spreading awareness in their respective communities. They lead a vari-

ety of interventions to bring about positive and healthy behavioural change amongst young people in their communities. This includes delivering outreach activities, referring young people to health services for treatment and supporting the Municipal Corporation of Delhi (MCD) in carrying out awareness-raising campaigns on malaria and dengue,” Saha shares.

Providing sustainable access to healthcare for all those who need it is a significant global challenge. The complexities surrounding the issue mean that there is no ‘one size fits all’ solution. Factors affecting access range from the affordability of medicines to the availability of healthcare systems and the resources to make them effective. “We believe it will take a combined global effort involving all related stakeholders to drive sustainable progress in increasing access to healthcare worldwide – and we know that, as a global biopharma company, we can make a meaningful contribution to that effort,” Saha commits. The availability of medicines is not always the primary challenge. Access to healthcare also depends on having a functional healthcare system and the right allocation of resources to make sure that medicines are used appropriately as part of overall health management. “For people in communities with limited healthcare infrastructure, we partner with others to help strengthen healthcare frameworks and capabilities,” she signs off.

the country to make this campaign a success. Termed as the Awareness Week on Antibiotic Knowledge and Education (AWAKE), this first-of-its-kind campaign in the country was conducted in seven major cities last year. “Our CSR teams regularly visit local government schools and colleges to educate students on self-hygiene, infection control practices and cleanliness. We are hopeful of taking this initiative to the next level over the years,” informs Aggarwal. Gauging the output reliability can only define the success of the word which has been carried out in the past. Commenting on the work analysis and successful parameter, Aggarwal explains, “We gauge the impact of our CSR activities through the difference we have made to the lives of people. Our CSR initiatives have been quite a success in this respect. The success of our AWAKE campaign can be accessed from the fact that 11,000 people joined EARS as members during the week-long exercise.” The company’s CSR activities are pan-India in nature, like tree plantation drives coinciding with Doctors’ Day and the awareness campaign to highlight the health threats associated with misuse of antibiotics, with the thrust on North India. The company has not won any CSR award but the company clarifies that they have never sought recognition on the basis of their CSR activities, they are only a part of the company's social commitment. The company does not have any flagship programme but aims to have its research wing to spread the AWAKE campaign across the nation.

Mix with the world of pharma, products, people & solutions

2-4 December 2014

Bombay Convention & Exhibition Centre Mumbai, India

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with 32,000 pharma professionals from all over the world @ CPhI & P-MEC India 2014! CPhI India has always met our expectations. The quality of the visitor is very high and majority of the potential customers we have met will lead to additional business for us which has made our participation very worthwhile

Heldin, UK Trade & Investment

CPhI & P-MEC India is the single biggest event in India and anybody who is associated with Pharma should participate. The quality of the visitor is pretty good and all the decision makers have been here. This time we had good walk-in along with good quality

Laxmikant, Mutisorb Technologies

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cover )

In a sweet spot No other industry touches a billion lives as much as pharmaceuticals, with a potential to improve health outcomes of people worldwide, yet it is in a midst of a flux when it comes to CSR. Shalini Gupta reports

aunched in 1996 and prescribed to millions of patients around the world, Lipitor, the cholesterol fighting drug from Pfizer remains the biggest blockbuster of all time. It is then not difficult to envisage how much impact pharma companies exercise on the society when it comes to ensuring healthy populations worldwide. For years, their mandate has been to plough money into researching and developing drugs that could help alleviate the disease burden of the socie-

42 EXPRESS PHARMA July 16-31, 2014

ty. That, however, is a part of their business, a growing impetus on corporate social responsibility (CSR) on the other hand ensures that they take their role in the society at large much more seriously.

The story so far As per the ‘triple bottom line’ approach on corporate social responsibility, three aspects (social, financial and environmental) determine the degree to which a business represents a sustainable organisation. Tradi-

tionally Big Pharma have been implementing a mixed bag of CSR programmes in the fields of global health, local communities, education, employees, ethics and transparency and environment. Pfizer for instance works on building partnerships in communities throughout the world to strengthen health systems, increasing access to medicines through patient assistance programmes, and finding sustainable solutions to the health challenges of today and tomorrow. Says Zitin Munshi, Associate,

CSR Services,Samhita Social Ventures, “Companies have dealt in causes as wide as livelihoods to as specific as palliative care. CSR initiatives have been related to core competencies and business practices of provision of healthcare products and services, spread across geographic presence of the company or driven by philanthropy. The beneficiary groups being catered to, have also ranged from children to terminally ill patients from low income groups.” A large Indian pharma

company partnered with physicians to execute a CSR programme in partnership with diagnostic laboratories for creating awareness and early detection of dyslipidemia. Engaging employees through CSR activities such as conducting health camps and creating infrastructure for community development are other ways. For instance, one of India’s top 10 pharma company has built a school in a village in Rajasthan. Donating medicines for elimination of diseases has been

( another favourite. In an effort to tackle lymphatic filariasis, schistosomiasis, trachoma, onchocerciasis and soil-transmitted helminthiasis, Merck, Pfizer, GlaxoSmithKline and Johnson & Johnson have collectively donated significant amounts of ivermectin, azithromycin, albendazole and mebendazole to the Neglected Tropical Diseases programme launched by USAID in 2005. Bayer HealthCare donated 50,000 ampoules of Germanin (suramin) in 2002 to the WHO to eliminate African sleeping sickness (Human African trypanosomiasis) renewing this commitment again in 2008 donating the same amount over a five-year period. Companies are also aligning their CSR objectives with global health initiatives and forming alliances with governments to support their health programmes, opines Sridhar Ganesan, Country Head, Hay Group India. “Pfizer has aligned their

CSR activities to support fulfilling UN millennium development goals for many countries. GSK has been a partner of the GAVI Alliance for years, offering large quantities of its vaccine products at low cost to help support immunisation efforts for children in emerging countries. It recently announced a fiveyear price freeze on three of its vaccines to help sustain national vaccine programmes of 22 developing countrieswho will stop receiving resources from GAVI by 2022,” he says. Indian companies are also doing their bit. Wockhardt Foundation, a full fledged NGO is working extensively as a NGO partner on CSR initiatives filling the gap in NGOs focussing on healthcare. Cipla has been running the CIPLA Palliative Care

“The business model itself should be heavily patientfocused and offer great value in improving their overall health outcomes” Ian Wilcox, Global MD, Life Science, Hay Group

THE MAIN FOCUS

and Training Centre since 1997 in Pune providing holistic care to 7700 terminally ill cancer patients and their families so far, free of charge. Others proactive in the space are Piramal Foundation (healthcare & water), Lupin Foundation (community development), Dr Reddy’s Foundation (strategic CSR). While Glenmark works on sustainable livelihoods, child health and medicine donation, Ranbaxy has been working on mobile health van, scholarships among others.

Socially responsible or CSR serious It is important to demarcate the line between a socially responsible company and the one which is consciously making an effort to integrate CSR into

the big picture. A socially responsible pharma company, needs to maintain fine balance between profit and people by making affordable medicine and the increased use of generic medicines, which not only has a large social impact but also directly impacts its profits, feels Adarsh Kataruka, Director, SoulAce Venture. “It is important to separate the component of being a socially responsible company by providing affordable medicines from fulfilling CSR regulation as introduced in April 2014 in the new Companies Act. Making affordable medicines will not constitute as part of the new CSR regulation but separate initiatives would need to be planned as CSR projects keeping regulation in mind,” he adds. He is also of the opinion that CSR within the pharma sector is still at a nascent stage with most of the initiatives undertaken till now either ad-hoc or not at a

cover ) large scale. Priya Naik, Founder and Joint Managing Director, Samhita Social Ventures offers an answer. “While some socially responsible pharma companies may be more comfortable leveraging their core competencies and business expertise in the pharma sector for contributing to social good. Others are afraid that this will be seen as more of marketing or 'something undertaken in the normal course of business.' Many pharma companies therefore consciously divorce CSR causes from their business operations and opt for education or livelihoods,” she opines. Pharma companies are also under increasing pressure to facilitate improved access to medicines for poor patients in the developing countries – lower the cost of the most urgently and most widely needed drugs, equitable distribution, etc. They are also subject to a variety of regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs. In addition challenges around high R&D costs and long development time makes it harder for companies to implement CSR activities that can be free of laws and operational challenges, says Ian Wilcox, Global MD, Life Science, Hay Group. He cites an example, “Development of orphan drugs for rare diseases can be seen as a CSR effort, however, the long time to bring the drug to market and the R&D costs makes the drugs increasingly unaffordable, resulting in the CSR element never being credited to the company receiving patent for this drug.” Naik sheds further light. “Unlike other consumer-oriented companies, pharma companies really need to think strategically about CSR, since their core business satisfies a social 'need', rather than a ‘want’. That is, medical intervention for low income beneficiaries as being a primary need as compared to buying a consumer good, which would be a ‘want’,” she points out. However, therein lies the opportunity, she feels. The complex and nuanced pharma ecosystem offers a huge stakeholder list both internal and external, in-

44 EXPRESS PHARMA July 16-31, 2014

cluding hospitals, doctors, medical representatives, pharmacies etc., each with its own set of priorities and requirements. Leveraging specific competencies or resources that each stakeholder brings, gives the company a diverse range of programme ideas to work on to satisfy stakeholder needs, she suggests. For example, any programme that reduces the role of, for instance, oncologists, for disseminating awareness related to financial or any other help, reduces the burden on them, in turn, allowing them to cater to more patients, will be welcomed by oncologists.

Finding the right model As companies navigate through pressures of bottomlines and the dynamics of running the business, formulating a CSR strategy that can create an impact and has long-term goals is a challenge to be overcome. Pharma companies’ performance on CSR is typically benchmarked on their contribution to access to medicines. Increasingly, it has been a challenge to meet these benchmarks, and to meet the needs of the high number of patients in need of medicines given the nature of increasing burden of disease and rising per capita healthcare cost, points Ganesan. “Companies need to look into sustainable business models and collaborations (both with competitors within the industry space and to adjacent markets such as healthcare technology, open innovation networks and new ways of R&D knowledge sharing), to ensure continuity in improving access to medicines and improving health outcomes,” he adds. Companies also have difficulty identifying a social cause and credible and

“It is important to separate the component of being a socially responsible company by providing affordable medicines from fulfilling CSR regulation as introduced in April 2014 in the new Companies Act Adarsh Kataruka, Director, Soul Ace Venture

“Unlike other consumer-oriented companies, pharma companies really need to think strategically about CSR, since their core business satisfies a social ‘need’, rather than a ‘want” Priya Naik, Founder and Joint Managing Director, Samhita Social Ventures

suitable NGO partners as well as monitoring and impact measurement along with clearly demarcating CSR spend from other activities such as health camps in rural or slum areas as part of their marketing and sales promotion activities, pitches in Naik, whose firm offers consulting services to corporates on CSR. So what is it that they need to do differently? Wilcox suggests prioritising the integration of ethical and transparent business practices as well as philanthropic endeavours as part of their business model. “The business model itself should be heavily patient-focused and offer great value in improving their overall health outcomes. They can set themselves apart by broadcasting personalised stories of these improved health outcomes to the general public via widespread media platforms and demonstrate its scalability at a population level,” he says. This helps give them a ‘sustainable’ competitive advantage adding value to not just patients but citizens on a global scale. Gathering adequate buy in both from internal as well as external shareholders in the company on CSR initiatives would be helpful. Kataruka thinks partnering on various healthcare initiatives being run as part of CSR by other companies, NGOs or government, where the pharma companies can supply medicines at subsidised price could be one way. This would not only ensure quality products are used in social initiatives, but such partnerships would help in increasing social impact. “Focussing on vaccination of Below Poverty Line families, who are not a part of their target product segment from business per-

spective is another way they are able to reach out without affecting their business,” he chips in. He is equally passionate about companies meeting the prioritised needs of the community around factory locations (mainly in underserved rural areas) who are directly or indirectly affected by the factory's presence. Identification of such areas alongwith need assessment and a long term action plan would help maximise the social impact as would expanding the focus beyond healthcare to education, livelihood, healthcare, drinking water, sanitation etc. in those areas. Naik adds that skills of local employees of the company could be leveraged for community development initiatives. After the companies bill, firms have realised CSR needs to be undertaken in a focussed manner, and ad-hoc initiatives will not suffice. Many of them are yet at a planning stage formulating their CSR policy and plan of action for the next few years. The bill is fairly recent so a lot of the implementation results since its passing have yet to materialise on a tangible scale. CSR consultants such as Samhita suggest starting off by internal stakeholder involvement for articulating the broader CSR approach for the company, understanding the intent behind their contribution to social good and identifying cause focus as prescribed under Schedule VII of the Companies Act 2013. This followed by assessment of community needs for further cause prioritisation and careful thinking around programme design would lead to mapping out the modalities of execution and impact that the company wishes to achieve throughout the programme implementation phase. It is important to clearly think through the monitoring and impact assessment process at the planning stage itself, stresses Naik. To sum it up, pharma industry is in a sweet spot as far as CSR is concerned. There are challenges, but as we can see, therein lie the opportunities It remains to be seen how this potential is optimised. shalini.g@expressindia.com

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THE MAIN FOCUS

INSIGHT

CSR: An opportunity for pharma companies

ADARSH KATARUKA, Director, SoulAce Social Venture

Adarsh Kataruka, Director, SoulAce Social Venture, talks about why each company needs to chart a CSR vision and work towards creating sustainable and long-term impact

o r p o ra t e social responsibility is currently a buzzword in India with the Companies Act 2013 making it mandatory to spend two per cent of profit for companies having profits of above ` five crores or turnover of ` 1,000 crores or net worth above ` 500 crores. Now with the new CSR regulation being applicable from April 1, 2014 for Indian companies as well as global companies having operations in India, it is important that each company charts a CSR vision and works towards creating sustainable and longterm impact. Also two per cent of profits would mean large pharmaceutical companies having CSR budgets going upto ` 50 crores annually to be spent in India. One of the key reasons, why CSR has been gaining momentum in the last few years and eventually becoming mandatory arises from the role the manufacturing firms play in and around their factory. Majority of the factories are either in rural region or on the outskirts of cities, which are surrounded by villages. In recent years, rural communities have started demanding better services of healthcare, education, potable drinking water, sanitation, livelihood opportunities etc. The expectation of these communities in the villages is the highest from the company

as directly or indirectly they are affected by the factory’s presence. The stark contrast in the visible facilities enjoyed by the company officials and the community, leads to increased expectation. The CSR notification also stresses on the need to focus on activities in and around company locations. Pharma companies have manufacturing setup across the country especially in hilly regions with better environment conditions like Baddi (Himachal Pradesh), Sikkim etc. As part of CSR, pharma companies should use this opportunity to develop innovative healthcare delivery models in communities surrounding their factory locations. This could help in replicating similar models for the large NGO sector and the government healthcare initiatives across different geographies. It is important for the companies, to first understand the prioritised needs of the community before planning initiatives, the intervention needs to have long-term focus instead of standalone ad-hoc initiatives. Initiatives should focus on eradicating certain prevalent diseases or checking fraudulent healthcare practices. Currently, very few pharma companies have been active in CSR. Companies like Glenmark Pharma have been working towards reducing child mortality in Madhya Pradesh and Rajasthan. Ranbaxy has also been running mobile health vans in selected villages in Punjab to

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meet healthcare needs of the disadvantaged villagers and has made an effort to reduce infant mortality rate in the region. Dr Reddy’s has been working on education and livelihood initiatives with welldefined goals and objectives. Cipla has established Palliative Care centre in Pune. One of the pharma companies, Wockhardt, seeing the gap in the healthcare delivery by the social sector, has established its own foundation and is working as an independent NGO bringing best of healthcare facilities to the needy in remote areas of the country. It works on range of healthcare issue as an implementing partner for Wockhardt and other corporates ranging from running mobile health van to providing water purification tablets. These are commendable initiatives but not necessarily done around the factory locations. Focusing on regions near its factories has certain long-term advantages. One advantage of working near the company locations is that the commitment of the respective company is greater and it can have deeper engagements with the communities, can have efficient monitoring mechanism and progress with set milestones to be achieved to have larger and long-term impact on the lives of marginalised and disadvantaged communities. Through the initiative there can be a higher level of employee engagement, especially near its manufacturing locations,

which also adds up to be a learning ground for its employees. If required, professional help should also be sorted towards creating plant level CSR strategy with short, medium and long-term objectives. If we look at top pharma companies in India, till now only a handful have been active in CSR considering their size of operations. Majority of them feel that they are already creating a social impact through their business and therefore are already acting as responsible citizens. With the new CSR law, pharma companies should take the lead in this direction and create path-breaking work towards changing the healthcare delivery models. Pharma companies can use their knowledge, network and dynamism in the healthcare sector to impact the lives of the poor bringing them affordable and accessible healthcare facilities. It is also an opportunity to partner with other corporate in designing collaborative solutions. Few ways in which pharma companies can align their CSR, which would also be in norm with the CSR regulation: ◆ Setup vaccination and awareness generation centres for different diseases prevalent in the regions it operates. This could also be done in collaboration with government in terms of using the existing infrastructure of district hospitals or even primary healthcare centre present in villages. ◆ Work in collaborations with CSR initiatives of other

pharma companies especially in Special Economic Zones (SEZ) regions to tap into larger CSR funds and expertise, which would also lead to enhance overall industry image ◆ Holistic healthcare delivery models around their factory locations, which can be replicated and showcased to the Government and other NGOs for development at larger scale. Another interesting phenomenon with the pharma companies is that their core business and the products are directly creating a social impact, therefore pharma companies walk a thin line when it comes to balancing their profitability and affordability of the medicines to the consumer. Some companies in the last 10 years have tied up with international organisations like World Health Organisation and tried to develop specific drugs for prevalent diseases in backward regions in India, Africa and Latin America. After eight to 10 years of research, Ranbaxy has launched specific improved drugs related to malaria and HIV. Cipla has worked towards making cancer drugs affordable in India and has also been working with international organisations to make medicines, drugs for neglected disease like malaria, HIV/AIDS etc. at affordable price. These might not come under new regulation by the Government on CSR, but plays an important role towards being a socially responsible pharma company.

EXPRESS PHARMA

July 16-31, 2014

MANAGEMENT LEGAL EAGLE

Will India’s IP law and policy‘Modi-fy’? Yogesh Pai, Assistant Professor of Law at National Law University, Delhi, says that greater certainty and predictability in IP law and policy devoid of regulatory capture is the key to unleash innovation INDIA’S COMPLIANCE with the World Trade Organisation’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has lead to significant domestic intellectual property (IP) reforms in the last two decades. However, foreign investors in research-based and creative industries have relentlessly questioned India’s IP policy for being ‘under-protective’ and for lack of ‘effective’ enforcement. Notwithstanding constant pressures that India has faced during these years, an April 2011 statement released by Prime Minister's Office (PMO) in the context of EU-India free-trade agreement (FTA) negotiations clarified that “...the Indian side shall not take on any obligation beyond TRIPS/domestic laws.” This position was largely taken keeping in mind concerns of domestic pharmaceutical industry and patient access groups. Such an approach was seen as providing a clear road map for maintaining a balanced IP regime for trade and investment protection vis-à-vis affordable access. Interestingly, the BJP’s manifesto exhorts to “embark on the path of IPRs and patents in a big way” and “establish an Intellectual Property Rights Regime which maximises the incentive for generation and protection of intellectual property for all type of inventors.” It also

46 EXPRESS PHARMA July 16-31, 2014

sion of maximalist IP standards will lead to both efficiency loss and transfer of benefits from southern consumers to northern innovators, which may further lead to a general decline in global welfare. Hence, simply linking trade and investment with IP does not bring welfare.

speaks about the need to “create courts specially equipped to deal with IPR cases.” Although such an ‘IP maximalist’ view may appear as a radical departure from the current policy framework, there are several reasons why the new dispensation will follow into the footsteps of the previous Government in maintaining a balanced IPR regime.

Disagreement on linking IP with trade and investment There is considerable disagreement among free-trade economists on linking strong domestic IP regulation with trade and investment protection. For example: economists like Jagadish Bhagwati, who

US foreign trade- IP policy driven by regulatory capture have otherwise advocated ‘free-trade’ and ‘free-market’ policies, oppose stronger IP regimes in developing countries. Based on the NorthSouth free-trade induced economic development dialectics, the argument is that exten-

Another free-trade economist, Aravind Panagariya, has recently gone on record to state that “India must call the US’ bluff on patents” since it is largely driven by US pharma lobbies engaged in regulatory capture. Driven by US industry groups, the self-

serving annual ‘Special 301Report’ recently released by the United States Trade Representative (USTR) has criticised India’s patent law for alleged ‘discriminatory’ treatment meted out to pharma inventions and for issuing compulsory licences on certain grounds. Aimed at preventing ‘evergreening’ of patents (an anticompetitive phenomenon where patent thickets prevent early entry of low-cost generics), section 3(d) of India’s Patents Act is seen as a barrier for pharma innovation. In 2013, the Indian Supreme Court affirmed denial of a patent under Section 3(d) to Swiss pharma major Novartis on its cancer drug ‘Glivec’ citing lack of ‘en-

hanced therapeutic efficacy’. In March 2013, India’s patent tribunal had confirmed issuance of a compulsory licence on Bayer’s drug Nexavar (Sorafenib) on grounds of higher prices (` 2,80,000 per patient/per month), unmet demand (up to 98 per cent) and on the ground of lack of working of the patented invention, which includes non-manufacturing of the patented product in India. Both these events haven’t gone down well with researchbased pharma companies.

Out-of- cycle review and likely trade wars By not listing India as a “priority foreign country” in its Special 301 Report (a designation reserved for severe violations of US intellectual property abroad), the US has temporarily avoided India’s threat to launch a WTO dispute for initiating unilateral action outside the WTO’s rule-based framework. However, the US has held in reserve its decision to designate India as “priority foreign country” by way of a mid-term “outof-cycle” review aimed at putting India’s new government in the dock. Special 301 may trigger sanctions by way of withdrawal of trade preferences worth $4.5 billion of India’s export to the US. India could also retaliate by placing higher anti-dumping duties on US imports. India may even contemplate moving the WTO dispute settlement against the US. Previously, a WTO panel has noted that a threat of unilateral action under the Special 301 adjudicatory process outside the WTO system undermines the basic principle of legitimacy of the WTO. The possibility of triggering protracted trade wars will push the US to retreat since India is on a relatively stronger footing at the WTO.

Domestic industrial policy priorities Top in the priority list of the new Government are measures to boost India’s manufacturing sector. Lowcost production is the hallmark of competitive manufacturing. However, stronger patent regimes are known to constrain abilities of competitors by impeding freedom to operate and raise input costs. Furthermore, India’s position in international climate-change negotiations is reflective of the need for low-cost access to patent protected ‘green’ technologies. In all likelihood, a policy that links IP protection with broader industrial policy objectives will remain a defining feature in the years to come. Business models which pro-

mote active technology transfer through licensing may find favour with the new Government. Much like any other business litigation, IP cases also require speedy disposal. In a resourceconstrained environment, special IP courts will require dedicating too many resources. However, any fundamental change in the IP law and policy landscape by turning such special courts into IP-plaintiffs’ court will have long-term consequences on the development of sound IP jurisprudence. Recent patent decisions of the US Supreme Court have rejected overly broad interpretations of patentable subject-matter that were largely influenced by pro-patent jurisprudence of the Federal Circuit courts created as special appellate courts on patent matters in early 1980s.

Need for a nuanced dialogue and transparency in IP decision making There are visible dangers in unilateral ratcheting –up IP norms. For example, The Pesticides Management Bill, 2008 proposes a five-year data exclusivity period for agrochemicals, a move clearly beyond the TRIPS requirement. Similarly, certain IP enforcement standards are also TRIPSplus. Evidently, no economic impact assessment has been conducted in such cases. An independent assessment of India’s bilateral investment treaties will reveal several onerous obligations that are beyond the common minimum standards of the TRIPS agreement. The ambitious mission of linking existing standards of domestic intellectual property protection with higher local innovation will require holistic approaches towards developing national innovation systems. It may also require out-of-box thinking beyond IP. Transparency in key IP policy decision making by formulating brightline guidelines and convergence in decision-making among several ministries must be prioritised. Without discounting the landmark reforms in India’s patent office administration during the last decade, one may emphasise the need for far more transparency, consistency and accountability. Greater certainty and predictability in IP law and policy devoid of regulatory capture is the key to unleash innovation and provide affordable access in a knowledge-based economy. (Views expressed are personal)

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EXPRESS PHARMA

July 16-31, 2014

RESEARCH CLINICAL UPDATE

Minimally invasive bone forming product ALLOB in Phase I/IIa trial for delayed union fracture BONE THERAPEUTICS, the regenerative therapy company addressing unmet medical needs in the field of bone diseases and orthopaedics, announced that the first patient has been treated with its novel allogeneic osteoblastic (boneforming) cell therapy product ALLOB in its phase I/IIa study for the treatment of delayed union fractures. ALLOB is the first ever allogeneic differentiated osteoblastic cell therapy product developed for the treatment of orthopaedic conditions. Allogeneic cell therapy involves the harvesting of cells from a healthy, universal donor, rather than from the patient being treated. ALLOB has shown safety and efficacy in preclinical studies and does not require any immunosuppressive side therapy. ALLOB has the potential to become a first-line treatment for impaired fracture healing,

thanks to its minimally invasive percutaneous administration. Delayed union fractures, defined by the absence of fracture healing after three months, affect around 600,000 to 900,000 new patients a year in Europe and the US. The current standard of care for delayed union fractures involves highly invasive surgery, which takes up to several hours followed by a long hospitalisation. ALLOB is injected by the orthopaedic surgeon in a single dose percutaneously, directly into the fracture site. No sideeffects have yet been reported. This first-in-human, proofof-concept, six months open-label phase I/IIa study is evaluating the safety and efficacy of ALLOB in the treatment of delayed union fractures of long bones. ALLOB treated patients will be assessed in comparison to baseline at two weeks, one, three and six months using clinical (e.g.,

pain, weight-bearing) and radiological evaluation. Ultimately, 32 patients with delayed union fractures will be enrolled in the study. Enrico Bastianelli, Chief Executive Officer, Bone Therapeutics commented, “Treating a patient for the first time with our allogeneic product ALLOB is a significant step forward for the progression of Bone Therapeutics’ regenerative therapy pipeline. Our allogeneic approach will lead to an ‘off-the-shelf ’ approach to treatment whilst offering delayed union patients the potential for a significant improvement in their condition without the need for invasive surgery. This first in human trial is an important milestone both for realising benefits for the patients as well as creating value for the company.” EP News Bureau-Mumbai

Queen’s scientist makes major cystic fibrosis breakthrough A QUEEN’S University doctor has played a key role in a major breakthrough to change the lives of cystic fibrosis sufferers. Queen’s University’s Professor Stuart Elborn, an international authority in respiratory medicine, with colleagues from the US and Australia have led pivotal studies of a new treatment for people with cystic fibrosis. The combination therapy, developed by Vertex (a Boston, USA company), improves lung function and reduces hospitalisations for patients with the most common type of cystic fibrosis.

48 EXPRESS PHARMA July 16-31, 2014

Two phase III studies of the drugs ivacaftor and lumacaftor, which included over 1,100 patients worldwide, built on previous studies of ivacaftor in patients with G551D and other related mutations. Ivacaftor is the first drug to treat the underlying causes of cystic fibrosis rather than just its symptoms and is currently approved for patients with the ‘celtic gene’ mutation carried by about four per cent of all patients and 1015 per cent of patients in Ireland. This therapy is a leading example of precision medicine, where treatment is based on a

test for genetic mutations. This recent trial looked at the treatment of patients with two copies of the F508DEL mutation which is carried by roughly half of all cystic-fibrosis patients. It found that a combination of ivacaftor with lumicaftor was effective in improving lung function between 2.6 and four per cent Cystic fibrosis is a fatal lung disease affecting 75,000 children and adults world-wide, and is caused by inherited genetic mutations that vary among different patient groups.

Professor Stuart Elborn, Dean of the School of Medicine, Dentistry and Biomedical Sciences at Queen’s University, and the European lead on the study, said, “This is a very significant breakthrough for people with cystic fibrosis. While we had previously found an effective treatment for those with the ‘celtic gene’ this new combination treatment has the potential to help roughly half of those with cystic fibrosis, those who have two copies the F508DEL mutation.” “This is another example of how Queen’s scientists are

working internationally to change lives around the world.” The study was led by a team from Europe Dr Stuart Elborn, Queen’s University Belfast, the USA - Dr Bonnie Ramsey, and Dr Michael Boyle, and Australia - Dr Claire Wainwright. Twelve patients from the Northern Ireland Adult and Paediatric Cystic Fibrosis Centres participated in the study. The local investigators were Dr Damian Downey and Dr Alistair Reid from the Belfast Health and Social Care Trust. EP News Bureau-Mumbai

RESEARCH UPDATES

Study paves way for a blood test to predict Alzheimer’s disease BRITISH SCIENTISTS have identified a set of 10 proteins in the blood that can predict the onset of Alzheimer’s and call this an important step towards developing a test for the incurable brain-wasting disease. Such a test could initially be used to select patients for clinical trials of experimental treatments being developed to try to halt progression of Alzheimer’s, the researchers said, and may one day move into routine use in doctors’ clinics. “Alzheimer’s begins to affect the brain many years before patients are diagnosed (and) many of our drug trials fail because by the time patients are given the drugs the brain has already been too severely affected,” said Simon Lovestone of Oxford University, who led this work from King’s College London. “A simple blood test could help us identify patients at a much earlier stage to take part in new trials and hopefully develop treatments,” he said. Alzheimer’s is the most common form of dementia, a brain-

wasting disease which in 2010 was estimated to be costing the world $604 billion a year. The fatal disease affects 44 million people worldwide, with the number set to triple by 2050, the campaign group Alzheimer’s Disease International says. Several big pharma firms including Roche, Eli Lilly, Merck & Co and Johnson & Johnson, are pursuing various approaches to get to the root cause of Alzheimer’s and try to find treatments to halt its progression. Yet over the past 15 years, more than 100 experimental Alzheimer’s drugs have failed in trial. Lovestone and other experts believe this may be because drug trials are conducted too late, in patients whose condition has already gone too far. A predictive test for use before people develop symptoms would help researchers select the right people for drug trials, and help show whether the experimental drugs are working. Previous studies have found that PET brain scans and tests of lumbar fluid can be used to pre-

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dict the onset of dementia from people with a less severe condition known as mild cognitive impairment (MCI), but these tests are expensive and invasive, so scientists are keen to develop a cheaper, simpler blood test. MCI includes problems with day-to-day memory, language and attention. It can be an early sign of dementia, or a symptom of stress or anxiety. Around 10 per cent of people diagnosed with MCI develop dementia

within a year. Apart from regular assessments to measure memory decline, there is currently no accurate way of predicting who will or won’t develop dementia. For this study, published in the journal Alzheimer's & Dementia, Lovestone's team used blood samples from 1,148 people — 476 with Alzheimer’s, 220 with mild cognitive impairment and 452 elderly controls without dementia. They were analysed for 26 proteins previ-

ously found to be linked with Alzheimer’s. The team found 16 of these 26 proteins to be strongly associated with brain shrinkage in either MCI or Alzheimer’s and then ran a second series of tests to see which of these could predict which patients would progress from MCI to Alzheimer’s. With this second series, they found a combination of 10 proteins capable of predicting with 87 per cent accuracy whether people with MCI would develop Alzheimer’s disease within a year. “The results reported today are interesting, but as the authors point out there is still a very large amount of work remaining until a usable blood test for Alzheimer’s disease becomes available,” said Adrian Pini of the MRC Center for Developmental Neurobiology at King's College London. James Pickett, head of research at the Alzheimer’s Society, said the research “does not mean that a blood test for dementia is just around the corner.” Reuters

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July 16-31, 2014

RESEARCH

FDAapproves Lymphoseek for head and neck cancer determination The most common side effects identified in clinical trial was pain or irritation at the injection site THE US Food and Drug Administration approved a new use for Lymphoseek (technetium 99m tilmanocept) injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region. In 2013, Lymphoseek was approved to help identify lymph nodes closest to a primary tumour in patients with breast cancer or melanoma. Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumour. By surgically removing and examining the lymph nodes that drain a tumour, a procedure called a biopsy,

doctors can sometimes determine if a cancer has spread. With this approval, Lymphoseek can now be used to guide testing of lymph nodes closest to a primary tumour for cancer, called a ‘sentinel’ lymph node biopsy, in patients with cancer of the head and neck. This new indication

will allow for the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer. “For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumour is an important diagnostic evaluation,” said ,

Director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. For this new indication, Lymphoseek’s safety and effectiveness were established in a clinical trial of 85 patients with squamous cell carcinoma of the lip, oral cavity, and skin. All patients were injected with Lymphoseek. Surgeons subsequently removed suspected lymph nodes those identified by Lymphoseek and those based upon tumour location and surgical practice for pathologic examination. Results showed that Lymphoseek guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system. EP News Bureau- Mumbai

FDAapproves Afrezza to treat diabetes THE US Food and Drug Administration approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycaemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal. An estimated 25.8 million (18.8 million diagnosed and 7.0 million undiagnosed) people in the US or approximately 8.3 per cent of the population have diabetes. The drug’s safety and effectiveness were evaluated in a total of 3,017 participants–1,026 participants with type I diabetes and 1,991 patients with

50 EXPRESS PHARMA July 16-31, 2014

type II diabetes. The efficacy of mealtime Afrezza in adult patients with type II diabetes patients was compared to meal-

time insulin aspart (fast-acting insulin), both in combination with basal insulin (long-acting insulin) in a 24 week study. At

week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c (haemoglobin A1c or glycosylated haemoglobin, a measure of blood sugar control) that met the pre-specified non-inferiority margin of 0.4 per cent. Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. Afrezza was studied in adults with type II diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type II diabetes patients was compared to placebo inhalation in a 24 week study. EP News Bureau- Mumbai

FDA approves Beleodaq THE US Food and Drug Administration approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of nonHodgkin lymphoma (NHL). PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous. In 2014, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,990 will die. PTCL represents about 10 to 15 per cent of NHLs in North America. Beleodaq works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous. It is intended for patients whose disease returned after treatment (relapsed) or did not respond to previous treatment (refractory). “This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. The FDA granted accelerated approval to Folotyn (pralatrexate) in 2009 for use in patients with relapsed or refractory PTCL and Istodax (romidepsin) in 2011 for the treatment of PTCL in patients who received at least one prior therapy. The safety and effectiveness of Beleodaq was evaluated in a clinical study involving 129 participants with relapsed or refractory PTCL. All participants were treated with Beleodaq until their disease progressed or side effects became unacceptable. Results showed 25.8 percent of participants had their cancer disappear (complete response) or shrink (partial response) after treatment. The most common side effects seen in Beleodaq-treated participants were nausea, fatigue, fever (pyrexia), low red blood cells (anemia), and vomiting. EP News Bureau-Mumbai

RESEARCH

Bone marrow transplant safe,effective for adult sickle cell patients: Study New York BONE MARROW transplants, which have already been used to cure sickle cell disease in children, may also hold promise for adults, according to a new study. Using a less toxic bone marrow transplantation technique, researchers brought 26 out of 30 adult patients to a point where a majority of their blood cells were healthy and they could drastically reduce their pain and other medications. “Many patients are not aware that there are curative options,” said Dr John Tisdale. “When you’re a child, you can get a transplant and be reasonably well assured that the result will be good. Now we have data that for adults it will be the same.” Tisdale is the study’s senior author and a senior investigator at the National Institutes of Health in Bethesda, Maryland. Sickle cell disease is an inherited disorder that causes red blood cells to contain an abnormal protein, which makes them

take on a sickle- or crescentshape. These defective cells can block small blood vessels, leading to tissue damage or stroke. Other complications of the disease are anaemia, jaundice, gallstones, severe leg and arm pain and spleen, liver and kidney damage. Approximately 100,000 Americans, primarily of African descent, have the disorder, which is most common in western Africa. Tisdale said children had been considered better candidates for bone marrow transplants, because they can tolerate the more toxic procedure, which typically includes using radiation to get rid of the patient’s own bone marrow and chemotherapy to eliminate the immune system. “What we decided to do was to try to figure out a way to do a bone marrow transplant that wasn’t so toxic and didn’t have so many side effects so we can apply it to adults with sickle cell disease,” he told. Bone marrow contains the progenitor cells that manufacture the body’s blood cells, so the

goal of a transplant is for the healthy donor marrow cells to become factories making blood cells free of the sickle cell trait. For the procedure, the researchers used lower doses of radiation to make room for the new marrow, which was provided by a brother or sister who was a complete immune match to the patient. They also used a smaller dose of chemotherapy to only weaken the immune system, rather than destroy it.

The patients were between the ages of 16 and 65 years old and enrolled in the study between July 2004 and October 2013, according to the report in JAMA, the journal of the American Medical Association. As of October 2013, the researchers write, 26 of the patients had successful transplants and none of them reported graftvs-host disease, which happens when the implanted immune cells attack the patient’s own

cells. Those with successful grafts also reported no hospitalisations for a crippling pain condition that’s common and chronic throughout the life of someone with sickle cell disease. “That’s huge,” Dr Allison King said of the findings. “Just off the results of this study, the strict interpretation shows people with sickle cell disease with matched siblings should not have age held against them.” King, of Washington University School of Medicine in St Louis, Missouri, co-wrote an editorial published alongside the new study. Of the few patients who rejected the donor graft, Tisdale said their own cells are allowed to repopulate their marrow unlike transplants for cancers like leukemia. King said the biggest limitation with a procedure like this is that they used bone marrow that was a complete match from the patients’ siblings. “For those that do, I think these patients should be offered a transplant if they’re interested in it.” Reuters

A4-weekhep C cure? Bristol to test drugs with Gilead’s Sovaldi New York IN THE race to find a faster cure for hepatitis C, BristolMyers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences’ blockbuster drug Sovaldi, hoping to cut treatment time to four weeks. Bristol-Myers disclosed plans for the exploratory 30-patient trial testing its three-drug combination with Sovaldi. Eric Hughes, the leader of Bristol’s global hepatitis programme, said the details were due to be posted on the clinicaltrials.gov website next week.

Sovaldi’s $84,000 price tag for a 12-week treatment has spurred outrage among insurers, state health officials and lawmakers who fear the cost of treating millions of Americans with the progressive liver disease will top $250 billion. Insurers are pushing Gilead’s rivals to offer lower prices when their hepatitis C medicines reach the market. Using the drug for a shorter course of treatment could, in theory, lower the cost, even when combined with Bristol’s therapies. Rivals Merck & Co and AbbVie are also racing to develop nextgeneration hepatitis C treat-

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ments that cure most people of the virus in a shorter time frame. But drug pricing experts expect Gilead and its rivals may still argue that the quicker cure represents a value to patients, buffering any steep price reductions. The new generation of oral drugs being developed by several companies has raised hepatitis C cure rates to well above 90 per cent from about 75 per cent without the need for interferon or ribavirin, which caused miserable side effects that led many patients to delay or drop treatment. The drugs in clinical trials have already

cut treatment time to 12 weeks from 24 to 48 weeks. Bristol's plan essentially revives an effort to test its drugs in combination with Sovaldi. It previously tested a single compound with Sovaldi, achieving cure rates close to 100 per cent in 12 weeks. But Gilead scrapped further testing in 2012, as it preferred to develop its own combination without a partner. Gilead’s pill that combines Sovaldi with its ledipasvir is expected to gain US approval this year for therapies of eight or 12 weeks, depending on the patient. The company is also testing the

combination as a six-week treatment. The go-it-alone strategy has already paid off as Gilead was first to market with Sovaldi, breaking pharma industry sales records with $2.3 billion in sales within a few months. The new study, set to begin in late July, will test a trio of Bristol drugs with Sovaldi in previously untreated patients with the most common Genotype 1 form of the virus. It will involve two groups of 15 patients each one getting four weeks of treatment and the other six. Reuters

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July 16-31, 2014

PACKAGING SPECIAL I N T E R V I E W

‘Asia will still remain the region with the highest growth rates’ Sanner sees the established Asian markets such as China and India showing the highest potential for further growth and started opening up a new market in India last year. Holger Frank, Chief Executive Officer, Sanner spells out the company’s refocused global strategy to Express Pharma

Sanner evolved from being a cork cutter and trader in 1894, into the number one supplier for pharmaceutical plastic packaging with integrated desiccants. With revenues of Euro 55 million in 2013, what is the target for this financial year? 2013 was yet again a good year for Sanner. With a 10 per cent growth, we surpassed the Euro 55 million mark. We not only increased our sales volume by 10 per cent, we also further enhanced our leading position in the pharma, medical and healthcare markets. This year we plan to further increase this growth. To achieve this goal, we will focus on developing and launching new products and on specific customer projects, for which we develop tailor-made packaging solutions. Which are the regions and countries showing fastest growth? What are the growth drivers? Just like many other plastics and packaging manufacturers who are active in the pharma markets around the globe, Sanner also sees the established Asian markets such as China and India showing the highest potential for further growth. Although we see a decrease in the overall economic growth in China, Asia will still remain the

52 EXPRESS PHARMA July 16-31, 2014

region with the highest growth rates. We started opening up a new market in India last year, which will give the Sanner group new impulses. Furthermore, we are again expanding our production site in China. The building work will be finished in 2014 and will make it even easier for Sanner to deliver high-quality products to markets in Asia. What is Sanner’s USP over competitors for its pharma customers? We have been the experts and the world market leader in desiccant packaging for more than 60 years. As desiccants are among the cost drivers for packaging, our primary intention is to clarify the exact requirements of our customers concerning shelflife and climatic conditions. Based on these requirements, we place our main focus on a tight package and then integrate the exact amount of desiccant. This way, we have been able to realise significant costsavings for some of our customers. Our second USP is the design and development of customised packaging. We have developed an extensive expertise in risk management and can draw on the competence to design a tailor-made package. Our customers don’t have to refer to a design agency, thus again

perfectly compatible with their filling lines.

We started opening up a new market in India last year, which will give the Sanner group new impulses significantly saving costs. Combined with our project management experience, open communication and fast decision processes within a project, our customers can be sure to receive a solution that fulfills their requirements and is

What are the technology and regulatory requirements for the manufacturing of integrated desiccants for the pharma industry? The manufacturing process of our packaging systems complies with current Good Manufacturing Practices (GMP) and should take place in a controlled environment. Above all, desiccants require a clean, dust-free and dry production environment. With our longterm experience in this field, our production sites offer the ideal conditions and comply with all such regulations. What was behind the launch of a new logo and tagline at CPhI Worldwide 2013? What are the highlights of the new strategy for pharma and healthcare customers? Sanner has refocused its strategy. The pharma, medical and healthcare markets have always been our home base, so we have now decided to concentrate on six market segments, which show the best potential for growth and innovation. Our new claim 'Sanner. Protecting Health' underlines this decision and highlights both standard and customised packaging for safe and precise pharma, healthcare and medical

technology solutions. We want to send a clear signal to our customers: Sanner is your partner for pharma and healthcare packaging. What will this mean for customers? By dividing our pharma portfolio into six new product categories, we want to underline what Sanner can do best – develop reliable, cost-efficient and safe packaging solutions for customers around the globe. The highlights of the Pharma Desiccant Packaging product category include the ‘360° Capsule’ desiccant capsules, which reliably protect products against moisture. Sanner has been the Asian market leader in Teststrip Packaging for many years. We have continuously developed our portfolio to include standard as well as customised solutions at a good priceperformance-ratio. As global market leader in effervescent packaging, we continuously offer new solutions to our customers, for instance with FlipTop closures or our new system solutions for complete packaging with or without decoration. In the pharma and medical packaging category, the eye care and ready-to-fill syringes segments, we emphasise our long-standing engineering expertise. Continuous quality management, regular risk

assessment and seamless documentation make sure that our customers receive highest quality products. Sanner has been in India since 2013. What are the plans for the Indian market? Has the market performed as per expectations? Who are your major clients? What is the staff strength currently and any plans to increase headcount? We have only just expanded our sales office in India and hired new sales representatives. We will continuously tap into this attractive market in the same way as we did in others. We concentrate on the major players and are very satisfied with the current development of our business. As a manufacturer we of

Sanner has refocused its strategy. The pharma, medical and healthcare markets have always been our home base, so we have now decided to concentrate on six market segments, which show the best potential for growth and innovation course also always examine the option of a local production facility, once our sales have established a market with high potential. What will be the strategies to achieve these targets? We have defined the key players for Sanner in the Indian market. Against this background, our sales team has a clear sales strategy. We will also adapt our portfolio with products specifically

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designed for the requirements of the Indian market. What are the trends, both on the customer/consumer side as well as technology side, that will drive the pharma packaging business? We see three major trends, i.e. child-resistant (CR) packaging, barrier properties, compliance and anti-counterfeiting; all of

which focus on the safety of both the product and the patient or end consumer. Products must be safe for patients to use. A malfunctioning child-proof cap, for instance, can have dramatic consequences. In parallel to the trend toward more convenience, we also pay close attention to the patientsâ&#x20AC;&#x2122; safety, for instance with our CR TabTec container thus protecting children from wrong

application. To protect products from harmful external effects, it is important to use the appropriate packaging material. Sensitive products demand for higher barrier properties that keep permeation of water vapour and oxygen as low as possible to protect the content. We are watching the regulatory developments with regard to compliance and anti-counterfeiting closely. As soon as international standards have been defined, we will come up with the matching solutions for rigid plastic packaging. With these topics, we believe that we cover the most important trends and are well prepared for the future in our industry.

EXPRESS PHARMA

July 16-31, 2014

PACKAGING SPECIAL NEWS

DGFTdelays barcode implementation on primary packages indefinitely Industry happy, Govt mandates self certification process Usha Sharma Mumbai THE DIRECTORATE General of Foreign Trade (DGFT) has recently issued a public notice informing the pharmaceutical industry in India that barcode implementation on primary packages meant for exports has been pushed back and effective date will be notified later. Commenting on the notice, Dr PV Appaji , Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) said, “The Government has been very considerate of our request to postpone the decision on primary packaging. We have tried to explain the extreme difficulties involved in barcoding on primary packing in terms of technology, cost and approvals required by overseas FDAs for label modifications etc.” Bhavin Mehta, Committee Member, Pharmexcil and Director, Kilitch Drugs said, “Barcode implementation on primary packages is a big concern and we feel the DGFT's public notice is an outcome of our constant approach. It is good for the industry since primary bar coding is very difficult at this moment as not too many agencies provide these services. There are few service providers in this domain but technologically it is economically not viable.” Nakul Pasricha, Chief Operating Officer, PharmaSecure mentioned, “The latest DGFT notification has two significant implications. Firstly, it delays implementation on primary packaging, giving manufacturers more time to address the operational and financial challenges of printing barcodes on strips, blisters, bottles and other packages.

54 EXPRESS PHARMA July 16-31, 2014

PharmaSecure has already been working with many of the large manufacturers in India to address these challenges, having successfully printed close to one billion codes on primary packages across plants in India. Therefore, we are confident this challenge can be addressed and we look forward to continuing to work to address it.” While speaking about the second implication, Pasricha informs about the significance of barcode implementation on secondary and tertiary packages and says, “The second implication is the reconfirmation of the tertiary and secondary deadlines, which we have seen is already spurring manufacturers to fully implement the regulation on all their lines. This is a positive step as it will ensure that at these two levels, packages are protected.” Mehta while explaining the glitches in the implementation process said, “To implement barcoding on primary packages, it is very difficult due to size restrictions on ampoule and vials and other dosage forms.” The date of effect for implementation of barcoding on primary level packaging was July 1, 2014 and now has been extended indefinitely. The Ministry of Commerce and Industry Department of Commerce, DGFT recently issued a gazette mentioning deferment in the date of effect for implementation of barcoding on primary level packaging on export consignment of pharmaceuticals and drugs for tracing and tracking purpose. The notice also mentions that in case, the Government of the importing country has mandated a specific requirement, the exporter has the option of adhering

to same and in such case, it would be necessary to comply with the stipulations at serial number a, b and c of para 3 (1) and if an exporter is seeking to avail exemption from bar coding prescribed by the Government of India, the exporter is given the option to move an application to Pharmexcil for this purpose, clearly specifying the nature of such an exemption in the interest of the exports from the country. Pharmexcil shall dispose of such applications on case to case basis with prior approval from the Government. Under the track and trace system, manufacturers would be required to maintain serialised record of exported pharma products for a minimum period of six months after the expiry date of the product. A self certification process has been mandated effective May 15, 2014 vide public notice and this shall continue to be applicable without any change. Authentication features will be added in due course and integrated with the track and trace system and the Government will set up a central portal for tracking tracing exported pharmaceutical products. While commenting on the future prospect of the implementation of bar-coding on primary packages, Mehta said, “In future, whenever the Government will re-think implementing (this technology), it will definitely discuss with the industry stakeholders and will arrive at a final decision after figuring out the issues which are associated with the implementation.” Pasricha pointed out, “We are confident of seeing full compliance at all levels in the coming years.” u.sharma@expressindia.com

rommelag completes 50 years It is a leading supplier of blow-fillseal machinery, under the brand name bottelpack IN 1963 Gerhard Hansen invented and built his first blowfill-seal (BFS) machine. In May 1964 he founded rommelag in Aarau, Switzerland to sell his products internationally. Today rommelag is a member of the Hansen Group headed by CEO Bernd Hansen, with sales companies in Switzerland, Germany, the US and China. It is the world’s leading supplier of blow-fill-seal machinery, with the brand name bottelpack. It’s a matter of three steps. All bottelpack machines operate according to the BFS principle. In a single automatic process they create containers

by means of bottelpack BFS systems is gaining increasing dominance. Plastic materials offer a number of advantages to manufacturers and users of infusion containers and ampoules. They are strong enough to be made very thin without risk of breaking, they are easily collapsible, and they are chemically inert. Thus handling is easy and safe, not only in hospitals but also in mobile operations. As a consequence they are finding increasing use in countries like China and India, where nationwide healthcare is still in the development phase.

from thermoplastic granules (blow), insert the contents (fill) and close them (seal). BFS technology does not require the cleaning and sterilisation processes that are essential in other kinds of container production. To provide maximum security in the aseptic packaging of sterile liquids, creams, ointments and vaccines, the machines are equipped with additional modules for quality assurance and monitoring. The modules include aseptic systems for automatic cleaning and sterilisation of lines that come into contact with products. Customers throughout the world quickly recognised the advantages of plastic containers. Aseptic packaging

Thanks to subcontracting by its sister companies Holopack in Germany and maropack in Switzerland, rommelag is able to offer a diverse range of products and services for packaging of liquids. It provides support to its customers in manufacturing trials, contract manufacturing, process development, qualification and validation. Customers can even move their bottelpack machines to Holopack Pharma 2020 for production. One can only hope that rommelag’s worldwide efforts to promote the use of aseptic plastic packaging meet with success. EP News Bureau – Mumbai

PACKAGING SPECIAL PROFILE

rommelag: Market leader of BFS technology

RUDOLF GEISS, General Manager, rommelag

Rudolf Geiss, General Manager, rommelag speaks about the company's investment in the development of products and services, as well as in product innovations and the expansion of the service range ROMMELAG HAS made a name for itself as the inventor, technology leader and worldwide market leader of the blowfill-seal (BFS) technology. The core product, BFS bottel pack machines, as well as downstream machinery such as infusion cap welding machines, high-voltage leak detectors, particle inspection machines or finishing lines, are distributed by sales and after-sales services in more than 80 countries around the globe.

A strong group with decades of experience Gerhard Hansen formed Thermo-Pack Germany for PE plastic film manufacturing, printing and sealing in 1952, and since then more than 50 years of experience in plastic processing have put rommelag at the forefront of BFS technology. Initially starting out with the extrusion of plastic film, the key driver for the group's expansion was the invention of the BFS process by the engineer Gerhard Hansen at the beginning of the 1960s. This was followed by the successive formation of machine building companies, sales companies and contract packaging companies. Today the rommelag group consists of an extensive network of specialised locations, with the two sales offices operating in Buchs, Switzerland, in Waiblingen, Germany and the two contact offices at Evergreen, CO, US and Shanghai, PR China. The contract packaging facilities, operating to current GMP standards, are located at

The company continuously invests in the development of products and services, as well as in product innovations and the expansion of the service rang. BFS bottelpack systems and additional devices are sold in over 80 countries worldwide, to customers in pharma, cosmetics and technical products holopack Verpackungstechnik in Untergröningen and Sulzbach, Germany and Maropack in Zell, Switzerland. Investments are ongoing, says Rudolf Geiss, General Manager, rommelag: “Both plants have recently installed new lines and facilities for BFS bottelpack systems, for filling biosimilars and vaccines, as well as the bottelpack Pharma Suite – and a designated BFS aseptic production facility also for operating customer-owned machines was opened last year.” The manufacturing facilities are based at Kocher-plastik Maschinenbau in SulzbachLaufen, Germany and Maroplastic, Reitnau, Switzerland. Finally, plastic film is manufactured at thermo-pack Kunststoff-Folien, Gaildorf, Germany. “In 2013 both these locations have increased their capacity through building extensions. At Kocher we installed a bottelpack training centre for the implementation of high quality training courses for customers.”

Leading market position The way rommelag sees its

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own position in the market is described by Geiss. Geiss says, “Our international customers' expanding requirements in the field of pharmaceuticals are continuously met by our newly developed strategies and our ongoing developments. Step by step development, starting with the design of packaging systems to the production of inline equipment, which can be added to the BFS bottelpack machines – this is how we have reached the position of the leading systems supplier in this field.” “We are a highly competent system supplier, equipped with extensive know-how and ingenuity, capable of designing and building according to individual specifications,” he adds. “Customers can rely on getting a unique range of products and services, enabling them to operate packaging processes with BFS bottelpack systems in a manner that is simple, safe and economical. As an innovative and reliable industry partner rommelag is placing a lot of emphasis on the provision of continuous support, efficient advice and worldwide cus-

tomer support from highly qualified employees".

Recent product developments The company continuously invests in the development of products and services, as well as in product innovations and the expansion of the service range, says Geiss, “An example would be the recent successful market introduction of the new generation of BFS bottelpack high performance range, which is exclusively fitted with electrical drives that manage to reduce unit costs for our customers yet again. During INTERPACK 2014 we presented a brand new development of a VIM ampoules testing station for the automatic In-process-testing of BFS-containers, as well as announcing a new optical particle-test-system.” The main market for the BFS bottelpack machines is the global pharma field, mainly for packaging sterile liquids, creams and ointments. A new and upcoming area are biosimilars and vaccines, and the operation of BFS bottelpack Co-

Extrusions-machines with multi-layer containers for sensitive filling goods. “We are permanently innovating and optimising our range of containers and closures — like our readyto-use — products of injection ampoules with integrated needles or the unit-dosage ampoules for eye, nose and eardrops with integrated dosage chamber, making preservatives redundant,” explains Geiss.

Expansion ahead BFS bottelpack systems and additional devices are sold in over 80 countries worldwide, to customers in pharma, cosmetics and technical products. The western industrial nations are important, with growing developments in Asia. “We are working on rolling out our market penetration on a global scale, within both the existing and the developing application fields for our technology,” add Geiss. Geiss expects further expansion for rommelag in the coming years: “Our BFS technology can offer a whole range of benefits, like aseptic properties, safe and cost-effective production process, low unit costs, high tamper resistance and advantages in the transport, storage, handling and application of finished packed products. Therefore we see a lot of additional growing space for our company, both within our key market of pharma and also within others, like the cosmetics, food and technical product areas, which are yet to discover how they can profit from the mentioned benefits.”

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July 16-31, 2014

PHARMA ALLY I N T E R V I E W

‘Our solutions save up to 30 per cent of energy costs and reduce carbon footprint’ As sustainability becomes a key driver for companies setting up businesses, efficiency and productivity requirements need to be worked in tandem. Michael Sullivan, Vice President, Healthcare Solutions, Schneider Electric, tells Shalini Gupta how his company is helping the pharmaceutical industry achieve that Tell us about your contribution to the pharma sector as a company. What areas do you contribute to? Pharma is a key vertical for Schneider Electric and the business has seen a double digit CAGR over past few years. Pharma is a growing sector in India and the India market contributes significantly towards the overall pharma business for Schneider Electric. Within the pharma business, we have pharmaceutical manufacturing, biotech and laboratories. All these verticals are growing in double digits. Biotech is experiencing the largest growth, followed by generics and pharma manufacturing. Biotech growth is driven by the market need to combat rare diseases by harnessing cellular and biomolecular processes. Generics growth is driven by payers’ pressure to make healthcare affordable. What solutions do you offer to the pharma industry? What needs does it meet? Pharma customers prioritise improved efficiency; reduced operating costs; information technology; preventing revenue lost to expiration; increased R&D productivity; and protecting intellectual property, materials, finished goods, and employees. Such goals demand flawless performance from every organisational facet while adhering to strict regulatory

56 EXPRESS PHARMA July 16-31, 2014

expectations. Rising energy costs and energy efficiency measures have become key drivers for sustainable development and corporate responsibility concerns. Schneider Electric delivers unparalleled building performance by creating a sustainable business which meets regulatory requirements, reduces time to market, and enhances the safety and security of employees and assets. Efficient and green, our solutions save up to 30 per cent of energy costs and reduce carbon footprint. With our EcoStruxure system architecture, companies benefit from one fully integrated system, while reducing CapEx by up to 15 percent. Our life sciences solutions enable customers to protect the health and improve the quality of life for the world’s population. Our laboratory solutions include building automation and control, HVAC control, lighting control, energy monitoring and control. Our security management systems help maximise the safety of employees, assets, and data by complying with security regulations, reducing risk, protecting revenue streams, and reducing operating costs. We help companies reduce energy costs through metering, monitoring, and management of energy thus avoiding power outages and quality variances with reliable energy.

greenhouse gas emission by 25 per cent. In their new Singapore facility, we have helped them reduce energy costs by 25 per cent, engineering costs by 50 per cent and save 10 per cent on the overall cost of the facility

Pharma is a key vertical for Schneider Electric and the business has seen a double digit CAGR over past few years Novartis, the world’s third-largest pharma company, has set a leading example of how energy management and conservation are key components to a sustainable business model. Nowhere is this better demonstrated than in their goal of reducing

Are the needs and requirements of pharma companies in India, the EU and the US same? What are the differences and similarities? The growth of Indian pharma companies is mainly driven by exports to the US and the EU as these companies help meet the patient needs by providing them with high-quality medicines at affordable prices. This necessitates the companies to meet regulatory compliance requirements of US FDA (US Food & Drug Administration) and EMA (European Medicines Agency); which in turn makes the needs and requirements of pharma companies across the world pretty much similar. However, Indian companies focused only on domestic market are not required to fulfill US FDA’s stringent regulatory compliance requirements. What are the infrastructure challenges that Indian pharma companies are struggling with? How do you help them navigate these better? ◆ Time to market(on time, on budget, to specification):

Our automation solutions comprising of safe and reliable power availability, state-of-the-art building automation and monitoring, best in class automation software and controllers help increase plant reliability, efficiency and product quality. ◆ Facility performance to protect the bottom line: Our software solutions help in real-time optimisation of critical production processes, by empowering production personnel to make the right decisions, thereby reducing wastage while improving productivity. ◆ Regulatory requirements and consequences: We have a team of 20 experts in life sciences FDA compliance services (e.g. 21CFR11), who provide expert services in meeting regulatory requirements. ◆ Energy costs: Our energy and sustainability services help reduce energy consumption by upto 30 per cent ◆ Worker safety: When integrated with security, “Total Environment Management” ensures that workers are safe and that required access controls and environmental data are available on-demand, enabling quality assurance personnel to quickly prove compliance with manufacturing processes/products/research integrity ◆ Improve the environment with our expertise and

sustainability solutions: Design, construct, and operate life sciences facilities and equipment with the aim to optimise performance and minimise energy consumption Tell us about the acquisition of Invensys and how has it helped you change the game in the pharma space? What capabilities does it bring? With the acquisition of Invensys, Schneider Electric is significantly enhancing its position as a provider of efficiency solutions, integrating power and automation. The acquisition will allow us to have a unique position in industrial and infrastructure end-markets and create substantial value for our customers, shareholders and employees. It will further complement

The growth of Indian pharma companies is mainly driven by exports to the US and the EU as these companies help meet the patient needs by providing them with high-quality medicines at affordable prices our offerings in software, MES batch control, asset management, inventory management, predictive maintenance, HMI / SCADA, compliance services, validation services, cyber security services, systems, DCS, PAC and controllers and recorders. Pharma manufacturing in India is catching up with the long-term benefits of green processes to improve

corporate image, reduce costs and achieving compliance at the same time. Your comments. Absolutely correct. Indian pharma companies are already among the most respected ones globally because of their strong commitment to quality and efficiency. As a natural adjacency to further strengthen their brandimage, they have started

appreciating the benefits of moving up the sustainability index by reducing carbon foot-print. This not only helps them improve their image, but also supports their positioning among global customers, especially because most of those companies are export oriented. Are Indian companies also looking at such solutions or only MNCs? By how much is the division growing in India? Export-oriented Indian companies are at par with MNCs and are striving to establish themselves in the same league as ‘big pharma.’ Growth in India is also in double digits, expected to accelerate more than the global average in years to come, driven by further investments in export-

oriented generic pharma manufacturing plants. With pharma companies worldwide looking at cost effectiveness, what remains the challenge for companies such as yours? Does it spell growth or shrinking revenues? Our solutions in fact help them lower their production costs by reducing wastage, increasing efficiency, availability and reliability of critical production processes. More and more companies have started appreciating the benefits of automation, which in turn is leading to increased demand for our reliable power, process and building automation and software solutions; leading to strong growth in revenues. shalini.g@expressindia.com

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IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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July 16-31, 2014

PHARMA ALLY VENDOR NEWS

Phenomenex adds two phases to Lux Chiral Bulk Media Line for preparative chromatography These two new phases join the existing purification media options of Cellulose-1 and Cellulose-2, providing a dependable, high-resolution screening set with a wide range of selectivity PHENOMENEX has announced the extension of its successful Lux chiral bulk media line to meet the needs of preparative chromatography applications. Lux Cellulose-3 and Cellulose-4, unique and complementary chiral stationary phases, are now available in a 10 μm particle size for preparative and batch chromatography applications. These two new phases join the existing purification media options of Cellulose1 and Cellulose-2, providing a dependable, high-resolution screening set with a wide range of selectivity. The new 10 μm particles are specifically designed for batch chromatography, and columns packed with these particles deliver increased efficiencies over 20 μm particles, enabling the

use of shorter columns. This saves both time and money by reducing solvent consumption. The Phenomenex Lux 20 μm particles are still a good choice for customers using simulated moving bed (SMB) technology. The four 10 μm Lux Cellulose chiral phases benefit from Phenomenex’s unique manufacturing process and silica coating technology. Lux Cellulose-1 uses cellulose tris (3, 5-dimethylphenylcarbamate) as the chiral selector. Lux Cellulose-2 provides a second chiral selector, cellulose tris (3-chloro-4methylphenylcarbamate) providing a unique chlorinated stationary phase with chiral recognition abilities that complement the Lux family of columns. Lux Cellulose-3 utilises Cellulose tris (4-methylbenzoate) as the

chiral selector, a variant cellulose ester derivative that offers unique chiral recognition abilities to provide enantiosepara-

tion when other phases fail. Lux Cellulose-4 incorporates Cellulose tris (4-chloro-3methylphenylcarbamate) as the

chiral selector – a chlorinated cellulose phenylcarbamate derivative that offers unique chiral recognition abilities. “The successful resolution of chiral compounds requires more than one stationary phase and the more phases you have to choose from, the better your chances of resolving enantiomers,” explains Marc Jacob, Product Manager, Phenomenex.” Phenomenex also offers several free tools for chiral chromatography. On the Phenomenex website, users are able to use the online chiral application search to quickly and easily search over 2,000 chiral applications by drawing the compound structure or by searching the application name. EP News Bureau - Mumbai

DHLadds India to Thermonet network The facilities in Mumbai, Bengaluru and Hyderabad are audited according to globally defined GDP to ensure conformity across the network DHL GLOBAL forwarding, the air and ocean freight specialist within Deutsche Post DHL has expanded its service offerings for the life sciences and healthcare industry in India by adding Mumbai, Bengaluru and Hyderabad to the company’s worldwide Thermonet network of certified life sciences stations. The custodian facility within the airports in these cities collectively offer 502 square metres of +2° to +8° celsius and 2,886 square metres of +15° to +25° celsius cold storage space to serve DHL’s

58 EXPRESS PHARMA July 16-31, 2014

global customer base in the life sciences and healthcare sector with temperature-controlled airfreight shipment needs. “Our customers in the life sciences and healthcare sector are looking for better ways to manage the risk of product damage and loss from temperature deviations in their supply chain. DHL Thermonet tackles these requirements and offers Indian consignors and consignees access to a reliable end-to-end cold chain facilities,” says Samar Nath, Chief Executive Officer,

DHL Global Forwarding, India. DHL is constantly expanding its global Thermonet network of certified life sciences stations and plans to reach 65 by end of 2014 and 80 by end of 2015. The

facilities in Mumbai, Bengaluru and Hyderabad are audited according to globally defined Good Distribution Practices (GDP) to ensure conformity across the network. In Hyderabad and Mumbai, there are five loading bays each, while Bengaluru is equipped with two bays. In addition, these sites offer temporary transit storage within bonded customs facilities. In the upcoming months, DHL plans to expand similar capabilities at Ahmedabad and Delhi. DHL Thermonet provides

seamless temperature visibility along the supply chain, 24/7 proactive monitoring and intervention based on pre-determined touch points and DHL’s RFID SmartSensor technology, that is also GDP certified. Temperature data and logistics events can be accessed via the proprietary LifeTrack IT platform that also houses all product-specific SOPs, facilitating early intervention and simplifying document control. EP News Bureau – Mumbai

PHARMA ALLY

Oracle Health Sciences Data Management Workbench launched To aggregate, reconcile and transform disparate sources of clinical trial data ORACLE HAS introduced Oracle Health Sciences Data Management Workbench. Using this researchers can integrate, reconcile and analyse clinical data faster and more accurately to automate data load, transform and cleanse processes. As a result, study sponsors can make faster, more informed decisions that improve control, support adaptive studies and accelerate clinical trials and time to market. Steve Rosenberg, Senior Vice President and General Manager, Oracle Health Sciences said, “As the industry’s only true end-toend data management solution, Oracle Health Sciences Data Management Workbench enables health sciences organisations to improve clinical programme productivity and reduce costs and risk by reducing study cycle times, improving data quality and decision making.”

Oracle Health Sciences Data Management Workbench enables health sciences organisations to accelerate clinical studies and boost programme productivity while helping to drive down the cost and risk of clinical trials. The solution, which is integrated witdelugeh Oracle Life Sciences Data Hub, automatically aggregates, integrates and reconciles the rapidly growing volume of data that clinical trials collect from internal and external data sources, including electronic data capture, laboratory, safety/pharmacovigilance, and drug supply systems. By doing so, it helps dramatically decrease the complexity of data management and reduce the cost of clinical trials. In addition, the solution automates the normalisation and transformation of multisource data to create a single source of truth for all stake-

Researchers can integrate, reconcile and analyse clinical data faster and more accurately to automate data load, transform and cleanse processes

holders in the clinical development process and helps enable rapid analysis to drive faster, more informed decisions. By providing this standardised data transformation, Oracle Health Sciences Data Management Workbench helps significantly increase efficiency by enabling researchers to pool data from multiple studies for programme development and submission. Also, by increasing data integration and standardising data formats throughout the study process, Oracle Health Sciences Data Management Workbench automates the identification and correction of discrepancies in multisource data that can jeopardise the validity of a study. As a result, the solution helps reduce costs and accelerate database lock. The standardised data formats used within the system are repeatable and reusable,

which reduces the time and cost of trial set-up. Using Oracle Health Sciences Data Management Workbench, organisations can also streamline compliance thanks to full traceability of data discrepancies as well as comprehensive security and audit trail capabilities. The solution is focused on helping health sciences organisations of all sizes create clinical trial management environments that increase efficiency and can scale with their needs. Oracle Health Sciences Data Management Workbench integrates with Oracle Health Sciences InForm to enable automated, bi-directional and real-time information flow between the systems. The integration helps improve data integrity across the enterprise and virtually eliminates the need to re-key data. EP News Bureau - Mumbai

Verizon extends healthcare focus to pharma sector The company also entered into a partnership agreement with rfXcel VERIZON IS extending its healthcare focus to now include the pharmaceutical and life sciences industries. This was recently announced at the Drug Information Association show in San Diego, California. Verizon, who has been helping to transform the delivery of healthcare in the US through a growing portfolio of IT solutions, unveiled two new industry-specific solutions designed to help companies keep up with increasing regulatory requirements for this sector. Available immediately in the US and Europe, Verizon is

launching a portfolio of GxP (Good x Practices) Services for managing sensitive clinical and drug manufacturing data in the Verizon cloud or from select data centres. The company also entered into a partnership agreement with rfXcel whereby Verizon will provide its complementary cloud and data centre service options to clients. rfXcel provides a serialisation solution that helps companies track and trace pharma from manufacturing to distribution. "Companies within the sector are struggling today to meet growing regulatory require-

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ments," said Rich Black, Vice President, Verizon’s healthcare practice. “We have found that our IT infrastructure which leverages our cloud, security and technical expertise can enable them to address this burden. We recently met with several large pharma companies and they were energised to learn that Verizon’s infrastructure services can be used to address what is clearly a pain point for them."

Five ways GxP benefits the pharma industry Verizon’s GxP services include colocation, managed hosting,

and enterprise cloud solutions in three of the company’s premier global data centres, as well as professional services to size/scope the architecture and enable deployment. Verizon’s GxP services are helping companies to take advantage of: Geographic coverage: Locations in North America (Culpeper, Va. and Miami, Fla.), and Europe (Amsterdam) Foundational security: GxP services come with a baseline ISO 27001 certification Quality management: Are managed under Verizon’s quality management programme to

deliver qualified infrastructure with appropriate sign-offs on standard operating procedures and to ensure proper training, policies and document/record control Agility enablement: Framework provides options to manage rapid growth, support alternative cost models (OPEX versus. CAPEX) and help accelerate new market expansions. Focus on core competencies: Enables the outsourcing of existing non-strategic systems to free up internal resources for strategic initiatives. EP News Bureau – Mumbai

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July 16-31, 2014

PHARMA ALLY PRODUCTS

CPC introduces AseptiQuik Connectors for biopharma industry COLDER PRODUCTS Company (CPC) has launched the company’s line of solutions for biopharmaceutical manufacturers seeking a robust sterile connector for single-use processing. AseptiQuik Connectors are a reliable, easy-to-use solution and the connector’s intuitive ‘Click, Pull, Twist’ design reduces complexity and the risk of operator error. AseptiQuik Connectors deliver quick, easy and reliable connections for Indian manufacturers using singleuse systems and enable sterile media transfer, even in nonsterile environments. The intuitive three-step process enables operators to quickly connect two single-use assemblies: an audible CLICK confirms the initial connection, PULL tabs allow simultaneous membrane removal and a simple TWIST of the integrated lock ring

provides secure final assembly. Extensive validation testing completed on post gamma and autoclave sterilised connectors confirms that external organisms are prevented from entering the flow path before, during or after connection. Testing includes functional performance, biocompatibility and three types of microbial ingress tests. CPC has also unveiled its AseptiQuik S small-format and AseptiQuik X largeformat connectors, offering

Indian biopharmaceutical manufacturers a full line of robust, sterile connectors with flow configurations ranging from 1/8 inch to 1-inch. The AseptiQuik S small format 1/8 inch and 1/4 inch connectors offer connections for small-flow applications and feature a genderless, easy-touse design. Applications include single-use bioreactors, cell banking and a range of sample applications. Terminations include 1/8 inch hose barb, 1/4 inch hose barb, 3/4 inch sanitary and MPC

male insert. The AseptiQuik X large format 1-inch connector provides quick and easy sterile connections for highflow applications, even in nonsterile environments. With this connector, the time to transfer large volumes of media is greatly reduced, saving valuable time and improving process efficiencies. Applications include single-use bioreactors, mixers and transfer lines. Terminations include 3/4 inch hose barb, 1-inch hose barb

and 1-1/2 inch sanitary. CPC’s MPC and MPX couplings and other bioprocessing connections met USP Class VI and ADCF requirements. They are manufactured in an ISO Class 7 certified cleanroom. Contact details Pavan Urs M Regional Sales Manager, India CPC Tel: +91 80 40 689 689 email: pavan.urs @ cpcworldwide.com Web: cpcworldwide.com

New launch by Brothers Pharmamach (India) A NEW concept of labelling has been launched by Brothers Pharmamach (India), which is a combination of wet glue and sticker (self-adhesive) labelling in one machine. Combi labelling is a perfect machine where customers require to operate their production line having application of wet glue as well as sticker label on the glass, plastic or pet bottles. There is no need

60 EXPRESS PHARMA July 16-31, 2014

to keep two separate labelling machines, just one Combi labelling machine will complete the requirement of two labelling operations in one machine. The machine with maximum seed of 300 labels per minute is suitable for vials and 250 labels per minute for bottles depending on product, diameter, height and length of labels.

Contact details BROTHERS PHARMAMACH (INDIA) (Registered office & Factory),Plot No.2, Phase II, GIDC, Vatva, Ahmedabad 382 445. Gujarat E-mail: sales@brothers.in brothers@usa.net Web: www.brothers.in www.ambicalabelling.com

Pic for representational purpose only

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For your Pharma export consignments, to assist you with your Good Distribution Practices (GDP) A Single Use Sub Zero to Low Temperature Monitoring Device

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Enviro also offers effective solutions for the monitoring of environmental parameters, suitable for Pharma Clean Rooms and Warehouses. Enviro Technologies for Accurate, Tamper Proof and therefore Authentic and Reliable monitoring of environmental parameters and analytical reports.

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PHARMA LIFE INSIGHT

Listening is the key Dr Savita Chari urges top managements of pharma companies to listen to medical representatives talk about their work and pay more heed to their problems for continuous progress THE MAIN point of this article is to point out that top management hardly ever ‘listens’ to what the field force has to say. There is hardly any pharma company that does not want to improve their implementation of strategy and achieve better results. Yet very few ‘listen’ to what their own field-staff want to say.

Insulated from knowing what really hurts Top management often argues that the field force have many other levels of operational hierarchy that one should not disturb. What happens in fact is that the “real problems hardly ever reach the top.” Top management is insulated from the real problems that people have in a company. They never get to know what really hurts some people.

Field force has many things to tell There are not just complaints but what could improve the results in the short run. If top management relies only on the existing lines of communication, truth is hardly ever going to reach the top. No one wants to bring ‘bad news’ to top management. Good news, encouraging news travels upward by middle manager, but bad news always gets suppressed, distorted and goes unnoticed. The real problem is that the Area Business Manager, the Regional Manager and/or the Zonal Manager often don’t have any time to listen to complaints from the field force. They have no access to top management unless top management itself is keen to listen.

In a survey conducted recently among 1800 medical representatives in Greater Mumbai, almost 70 per cent of them pointed out that no top management person ever gets to know what is critical and needs to be changed Bad news is actually good news

Ask yourself this simple question

Most senior managers know that bad news from the field is actually good news. You need to have the transparency to learn periodically from your own sales force, what can be corrected and improved. In a survey conducted recently among 1800 medical representatives of pharma companies in Greater Mumbai, almost 70 per cent of representatives pointed out that no top management person ever gets to know what is critical and needs to be changed. This is not because ‘badnews’ is suppressed but in the hurly burly of running a business top management hardly has time to ‘listen’ to what the sales-force wants to say.

When did your top management listen to your field-force directly? Almost over 70 per cent of medical representatives said company top management is insulated from facts and bad news does not reach top management. It gets suppressed and killed somewhere so top management is often unaware of what is going wrong. So corrected action is difficult. If top management makes it a point to come and listen what field-force problems are corrective action can be generated. Those who have a ‘system’ to listen to the field-force do better. Little wonder that the company which listens is one of the leading Indian companies among the top three.

Being heard can be therapeutic

When to listen?

The field force feels better when they are heard and this has a big impact on their morale. Only one major Indian company seems have had the ‘culture’ where the Joint Managing Director met field-force and asked them to speak. And he listened carefully. He went back to his office and wanted corrective action to be taken. Such top management intervention is very effective.

Top management must listen periodically. The field-force must feel free to say what they want to. Like promotional material does not ‘reach’ on time etc. or that the material is too complicated to deliver. The material that comes from head office is often long and no doctor enjoys listening to such long stories. More importantly, the representatives often do not enjoy detailing the material that is too long.

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The real problem The real problem goes much deeper: Can you detail the same material for three or four months to doctors? What is the level of fatigue in your field-staff if they have to ‘detail’ long messages that companies prepare for three or four months without any changes? Implementation no longer remains a major area of excellence. There is compromise all around. Unless top management is willing to listen to the front-line representatives at least twice a year, they will never know what is responsible for indifferent execution of strategies and what is hurting them. Top management could refuse to delegate the listening part to other senior managers. When you listen yourself, you hear so much more and you can take corrective action. Managers recalled how the Joint Managing Director of one company used to periodically listen directly from the representatives. He preferred to listen and get back and take appropriate action.

Intervention is very effective Such intervention by top management is very effective

DR SAVITA CHARI, Senior Research Associate in the School of Business Management, NMIMS

way to know what needs to be improved. It also indicates that facts cannot be suppressed and the system is transparent enough to throw up real problems that are hurting people who are in the Sharpe end of selling. Periodic ‘listening’ is therapeutic for the field-force and very useful for top management. The seniormost people who listen to field problems and also make field staff feel they are supported. This improves employee morale further.

Action taken Undoubtedly, listening alone is not enough but listening is the first step. Top management has to ensure that remedial action is taken so that one does not live with the problems. No two organisations have the same problem. Yet there are areas where corrective action must be taken.

Courage to listen Few top management persons have the courage to listen to problems and are willing to solve problems. Field force develops a different kind of trust in management; they know that what they are saying is hard. It makes management so much more authentic. Continuous improvement is possible only when top management periodically listens problems of force and are asking to take corrective action. (About the author: Dr Savita Chari is a Sr Research Associate in the School of Business Management, NMIMS, deemed to be University in Mumbai)

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PHARMA LIFE INITIATIVE

Sipra presents innovative pharma research award Awards were given to students undertaking research programme at reputed academia pan India THE BOARD of Sipra Labs, as part of its promotion of research activities, gave away ‘Sipra Innovative Pharma Research Award’ SIPRA-14 to young researchers working in the area of pharma sciences. The award profile comprised gold, silver, bronze medals along with cash prize of ` 50,000, ` 30,000 and ` 10,000 respectively. Selected papers of the symposium will be published as a special issue in The Austin Journal of Pharmacology & Therapeutics with International Standard Serial Number (ISSN) number. Around 300 research papers were submitted by the students from various academic institutions. A total of 115 papers were shortlisted, based on the recommendation of the evaluators for making poster presentation at Sipra premises in Hyderabad. Poster presentations were reviewed by top research academicians and senior research people from the industry. The first level of screening was done

by a team of eight jury members and shortlisted 12 papers made detailed power point presentations to the jury. Five papers were selected for the awards. JVG Pradeep of SriKrishnadevaraya University, Anantapur received the gold medal with a cash prize of ` 50,000. Kishore Chittimalli, G Pulla Reddy College of Pharmacy, Hyderabad received silver medal

with a cash prize of ` 30,000. Three bronze medals with a cash prize of ` 10,000 each were given to Tadiboyina Sirisha, JSS College of Pharmacy, JSS University, Mysore; Gudibandi Phani C Reddy, Mallareddy Institute of Pharmaceutical Sciences, Hakimpet, Secunderabad and S Shalini, Sri Shivani College of Pharmacy, Warangal. The awards were given by

the Chief Guest Dr PJ Sudhakar, Additional Director General, PIB, Ministry of Information and Broadcasting, Government of India. The chief guest Dr CH Mohan Rao, Director, Centre for Cellular and Molecular Biology (CCMB), addressed the participants and emphasised that research in life science is very much advanced.

The Guest of Honour Dr B Sesikeran, Former Director, National Institute of Nutrition (NIN) and Chairman, Review Committee on Genetic Manipulation (RCGM) addressed the participants and said, “Biotechnology and pharmacy have become synonyms and therefore the pharmacist must understand the advances in biotechnology vis-à-vis biotechnologist must understand how they can translate the finding in clinical use.” Dr Venkata Reddy, Ex Director Drugs Controller, AP stressed on the importance of research in academic institutions. There is a lack of facilities and initiatives in academic institutions. Hence he suggested public, private partnerships for promoting pharma sector research. He applauded the effort of Sipra in initiating private, public co-operation in the field of research. EP News Bureau-Mumbai

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