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Cover Story Light at the end of the tunnel? Pharma Ally ‘Technology can help reduce the cost of drugs’ 16-31 MARCH 2015,` 40
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CONTENTS
‘SALARYINCREASES FOR PHARMAHAVE BEEN HIGHER THAN OVERALLINDUSTRY’
Vol.10 No.10 MARCH 16-31, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty
Pharma has been one of the topmost industries when it comes to recruitment, and this year hasn't been any different. Anandorup Ghose, Rewards Consulting Practice Leader at Aon Hewitt India, shares the outlook for the coming year in an interview with Shalini Gupta | P63
BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua
MARKET
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STEMPEUTICS RECEIVES US PROCESS PATENT FOR STEMPEUCEL
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SUN PHARMA TO BUY GSK’S OPIATES BIZ IN OZ
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EXPERTS LAUD INCLUSION OF NCDS IN DRAFT NATIONAL HEALTH POLICY
15
NIPER TO ORGANISE NATIONAL CONFERENCE ON BULK DRUGS
Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma 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
P26: INSIGHT
PHARMA ALLY
Impact of IT on Indian pharma industry
RESEARCH
29
BIOTRONIK BIOLUX P-I CLINICAL STUDY RESULTS PUBLISHED
30
US FDA APPROVES ASTELLAS DRUG FOR INVASIVE FUNGAL INFECTIONS
31
NOVARTIS WINS APPROVAL FOR FIRST US BIOSIMILAR DRUG
P28: REPORT Growth hormone therapy market favours biobetters over biosimilars
P38: VENDOR NEWS
34
PTI launches game-based learning for pharma, biotech and medical device industries
‘OUR VISION AT NAVITAS IS TO BE THE BEST KNOWLEDGE COMPANY IN THE LIFE SCIENCES R&D SPACE’
P38: PRODUCT BÜCHI Labortechnik launches Rotavapor R-100 System – The Essential Solution
P64: NEWS Kiran Mazumdar-Shaw honoured by Federation University Australia
36
‘TECHNOLOGY CAN HELP REDUCE THE COST OF DRUGS’
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
Intent right, but implementation is key
F
inance Minister Arun Jaitley’s first Union Budget had nothing special for the pharmaceutical industry. The biggest takeaway would probably be the proposal to set up three new National Institutes of Pharmaceuticals Education and Research. The government hopes that this would encourage pharma education and research, but all such institutes have a long gestation period, and the industry was hoping for immediate relief in terms of incentives for pharma companies to up their R&D spend. This has been a long standing demand, which successive governments have failed to address satisfactorily. The ‘Atal Innovation Mission’ could be seen as an attempt to encourage innovators but with a proposed investment of just `150 crore, this is being seen as too little to make a real difference any time soon. All hopes that the nine-month-old Narendra Modi government would prove different were dashed, inspite of promising and much-talked programmes like Make in India, Skill India, Swachh Bharat, which have a direct connect with the sector. The industry was looking for details on how these programmes would be implemented, but this budget was all about broad strokes and laying out a roadmap, rather than getting into the nitty-gritty. No doubt pharma companies will benefit from other general measures like the proposal to reduce corporate tax from 30 per cent to 25 per cent, rationalise exemptions, increase spend on power generation and infrastructure and the implementation of GST from April next year. (For more budget reactions from the industry, see story, 'Budget blues', pages 24-25) All eyes are now pinned on key policies under review by the Department of Pharmaceuticals (DoP) and the National Pharmaceutical Pricing Authority (NPPA). While the DoP is understood to be finalising a bulk drug policy designed to stimulate investment into the intermediates and bulk drug sector, the NPPA has just released the revised National List of Essential Medicines (NLEM 2015). The NPPA has also launched the Pharma Jan Samadhan scheme, which is an online system designed to allow consumers to register their complaints regarding availability and pricing of medicines online. While industry is still absorbing the finer nuances of the NLEM 2015, this online redressal system is surely a welcome
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The government has declared this year as the Year of APIs but will this remain a catchy slogan or translate into tangible results?
attempt at transparency and accountability. By March end, we should also hopefully see the release of the new bulk drug policy and if it incorporates all key suggestions put forth by industry associations over the past few months, the policy will go a long way towards making the pharma industry in India self sufficient in key APIs, intermediates and bulk drugs. An IDMA white paper on the 'Journey towards Pharma Vision 2020 and beyond', has an annexure listing some of the key fermentation API units that were forced to shut down over the past few decades. As the lead story in our cover story section points out, today we are dependent on China for over 80 per cent of key intermediates, and this reveals a chink in our armour. The government has declared this year as the Year of APIs but will this remain a catchy slogan or translate into tangible results? (See story ‘Light at the end of the tunnel?’, pages 18-22)) We have already faced the brunt of this dependence. In the run up to the 2008 Beijing Olympics, when the Chinese government directed major industries to stop production so that air quality could improve, pharma companies in India were hit by a dwindling supply of key intermediates from China. Today, we have diversified our supply chain to some extent but the reality is that we can still be held hostage to escalating prices of key inputs. Unfortunately, the impact of these policies will be felt only a few years down the line so the government needs to fast track implementation of such policy initiatives. In a hard hitting article, Nishant V Berlia, Member Management Board, Apeejay Stya & Svran Group, argues how further inaction on this front will force diversified groups like his to divert resources away from their pharma verticals, not merely due to vanishing profits but the risks of trying to manage highs and lows of input prices that cannot be passed on to consumers as well as the uncertainty of the NLEM which is revised every three years. (See article, ‘The domestic underpinning of exports: Troubles in the world’s pharmacy’, page 23) One cannot but agree that this is certainly not a recipe for Make in India.
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
MARKET COMPANY WATCH
Stempeutics receives US process patent for Stempeucel Will help patients suffering from Critical Limb Ischemia (CLI) STEMPEUTICS Research, a group company of Manipal Education and Medical Group and a joint venture with Cipla Group, announced that the United States Patent and Trademarks Office (USPTO) granted a US process patent for its novel stem-cell based drug Stempeucel. Stempeucel will initially be used for the treatment of Critical Limb Ischemia (CLI) and is a breakthrough treatment option which directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself. CLI is a progressive form of
peripheral arterial disease which blocks the arteries in the lower extremities, resulting into reduction of the blood flow. It is a debilitating disease which affects patients with severe pain in the feet or toes. Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors. The company’s proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients. This approach also allows more than one million
Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy adults
patient doses from a single set of master cell banks, which is unique in regenerative medicine. The proprietary technology allows Stempeucel to extend the therapeutic potential of the drug across multiple disease categories. Commenting on the US patent, BN Manohar, Chief Executive Officer, Stempeutics said, “The patent granted by USPTO is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores the global leadership in allogeneic, pooled MSC technology. We believe that the Stempeucel product is a
game-changer offering an advanced therapeutic treatment for millions of patient suffering with this dreadful disease.” Chandru Chawla, Head, Cipla New Ventures said, “Through Cipla Group’s investment in Stempeutics, we are demonstrating a firm commitment bringing the next generation of biologics in order to address unmet medical needs. With this novel Stempeucel technology, we are supporting Stempeutics discovery of this first-of-its-kind regenerative medicine.” EP News Bureau – Mumbai
Novartis completes series of transactions with GSK Acquires certain oncology products and pipeline compounds from GSK NOVARTIS HAS completed a series of transactions with GlaxoSmithKline (GSK). It includes the acquisition of certain oncology products and pipeline compounds from GSK for the creation of a world-leading consumer healthcare business through a joint venture that combines the two companies’ consumer divisions, and the divestiture of the Novartis noninfluenza vaccines business to GSK. The transactions were announced in April 2014 as part of the Novartis global portfolio transformation. Joseph Jimenez, Chief Executive Officer, Novartis siad, “We expect this evolution of our strategy to improve margin performance and position us well to meet future changes in the healthcare industry.”
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it is anticipated that Novartis will be able to optimise the therapies acquired from GSK. Novartis also has opt-in rights for GSK’s current and future oncology R&D pipeline (excluding oncology vaccines), which could be a source of new compounds and new targets Since the end of 2013, Novartis has engaged in a series of transactions to sharpen the company’s focus on three core business segments with global scale: innovative pharmaceuticals, eye care and generics. Novartis Oncology now manages a portfolio of 22 oncology and hematology medicines to treat more than 25 conditions
worldwide. Newly-acquired therapies in melanoma, renal cell carcinoma and haematology complement Novartis Oncology’s existing group of practicechanging medicines to create a large portfolio of drugs in oncology and haematology, targeting important biological disease pathways. Based on the depth and
breadth of the Novartis Oncology R&D and commercial capabilities, it is anticipated that Novartis will be able to optimise the therapies acquired from GSK. These include: Tafinlar, Votrient, Promacta. Novartis also has opt-in rights for GSK’s current and future oncology R&D pipeline (excluding oncology vaccines),
which could be a source of new compounds and new targets. Sales of the acquired GSK oncology products in 2014 were approximately $2 billion and grew approximately 32 per cent in local currency against 2013. Novartis OTC and GSK Consumer Healthcare jointly form a global consumer healthcare leader in which Novartis maintains significant interest through the ownership of a 36.5 per cent share. GSK Consumer Healthcare is expected to have leading positions in four key OTC categories – wellness, oral health, nutrition and skin health. The joint venture has scale and commercial presence in the developed world as well as in key emerging markets. EP News Bureau – Mumbai
Sun Pharma to buy GSK’s opiates biz in Oz To buy GSK’s opiates business in Australia GLAXOSMITHKLINE (GSK) and Sun Pharmaceutical Industries announced that their respective, wholly-owned subsidiaries have reached an agreement related to GSK’s opiates business in Australia. The current GSK Opiates business including related manufacturing sites in Latrobe (Tasmania) and Port Fairy (Victoria) as well as its portfolio of opiates products along with inventory, will transfer to a subsidiary of Sun Pharma. The product portfolio consists of poppy-derived opiate raw materials that are primarily used in the manufacture of analgesics for the treatment of moderate to severe pain.
The transaction will allow GSK to simplify its operations in Australia
believe now is the right time to hand this business over to someone else.” Iftach Seri, Executive Vice
President of API business, Sun Pharma said, “The global opiates market holds good potential and the addition of
GSK’s opiates business will strengthen our positioning further. The acquisition is a part of our strategy towards building
our portfolio of opiates and accessing strong capabilities in this segment.” EP News Bureau – Mumbai
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March 16-31, 2015
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MARKET
Experts laud inclusion of NCDs in draft National Health Policy Advocate key intervention strategies to address growing burden MEDICAL practitioners and health policy analysts across India have strongly advocated the need for an integrated action plan to address the growing burden of non communicable diseases (NCDs) in the country. While lauding the inclusion of NCDs for the first time in the draft National Health Policy 2015, it is being termed as a formative step towards achieving the vision of healthy India. The health experts emphasised that it is important to have a result-oriented action plan, with specific focus on awareness and early diagnosis, systematic approach to NCDs, healthcare financing, and training and development of healthcare workers and paramedical staff. Underlining the need for an integrated action plan for NCDs in India, Dr Kenneth Thorpe, Chairman of the Partnership to Fight Chronic Diseases (PFCD)
A recent study by the WHO has found that nearly 26 per cent of the population in India are at the risk of dying young (30-70) from one of the four main NCDs said, “NCDs are the major cause of mortality in India. Building and strengthening primary healthcare network with a focus on disease screening, prevention, risk-factor control and health promotion should form the rudimentary structure of the integrated action plan to reduce morbidity and mortality associated with NCDs.” He further said that the training and development of healthcare workers in primary
setups as well as healthcare financing are equally critical for effective implementation of the action plan. Apart from taking its toll on health, NCDs also affect productivity and economic growth. A recent study by the WHO has found that nearly 26 per cent of the population in India are at the risk of dying young (30-70) from one of the four main NCDs. Dr Anand Krishnan, Professor, Center for Community
Medicine, AIIMS – New Delhi said, “India is facing a serious threat from NCDs. A lot has been said and recommended when it comes to preventing and controlling the continuously growing burden of NCDs. It is crucial that both the government and private sector should adopt a unified approach and work in close coordination to identify effective solutions and reduce NCDs burden. Now it is high time that the government should frame strong policies and guidelines, and at the same time create a framework and infrastructure to execute them efficiently, in order to deal with the growing burden.” A unique combination of disease-specific insurance products, medicines, innovative technology and lifestyle changes can be very beneficial in thwarting the challenge posed by NCDs. EP News Bureau – Mumbai
NSF Int’l releases GMP auditing prog To help India’s pharmaceutical excipient manufacturers demonstrate regulatory compliance, safety and quality GLOBAL PUBLIC health organisation NSF International has published the first American National Standard for pharma excipients NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. The new standard and auditing programme assists Indian manufacturers in demonstrating the regulatory compliance, safety and quality of their excipient products to pharma manufacturers in the US and worldwide. Most pharma formulations contain 70-90 per cent excipients, which serve as tastemaskers, glidants, antioxidants, flow aids, binding agents or
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other purposes that facilitate the manufacturing process and improve chemical stability of pharma. The globalisation of the pharma industry combined with a global regulatory focus on preventing counterfeits and adulterated products has created a need for a comprehensive excipient quality and control standard. For example, the Food and Drug Administration Safety and Innovation Act (FDASIA) now requires US manufacturers to verify and document that the raw materials used in finished products are also meeting appropriate GMPs. The NSF/IPEC/ANSI 363 standard for pharma excipient GMPs provides a harmonised
and comprehensive set of criteria for the quality management systems used in the manufacture of pharma excipients worldwide. The NSF/IPEC/ANSI 363 standard was developed in partnership with the International Pharmaceutical Excipients Council (IPEC) and input from a committee of pharma excipient experts from regulatory, industry and academic fields. The standard references 14 regulatory guidelines and industry standards for excipients, including US Food and Drug Administration regulations, International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH), and International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients. “Through developing NSF/IPEC/ANSI 363 and its corollary certification programme, NSF International is providing a means for excipient suppliers to demonstrate to pharma manufacturers that they meet the necessary GMP requirements,” said Maxine Fritz, Executive Vice President Pharma Biotech, NSF Health Sciences, a division of NSF International. EP News Bureau – Mumbai
DRLopens formulation development laboratory DR. REDDY’S Laboratories’ (DRL) Custom Pharmaceutical Services (CPS) division has expanded its existing custom service facilities with a new formulation development laboratory in Miyapur, Hyderabad. Bringing together the existing API development team and the formulation teams at one location will accelerate project timelines, reduce costs and simplify licensing processes for CPS’ pharma customers. According to a company release, with this expansion, the laboratories will form a centre of excellence for fully integrated
The labs will form a centre of excellence for API and formulation development services API and formulation development services, including pre-formulation studies, prototype formulation development, process development and optimisation. These development capabilities will seamlessly integrate CPS’ offerings of cGMP supplies for clinical trials, registration batches and commercial manufacture. “This new centre of excellence for formulation development services reflects our on-going focus to better serve our pharma customers. Access to our integrated expertise and resources will bring their drug product to market in an even quicker and more cost-efficient manner than before,” said Anurag Roy, Vice President, Global Business Head at Dr Reddy’s CPS. EP News Bureau – Mumbai
MARKET PRE EVENT
NIPER to organise national conference on bulk drugs Discussions will be held on opportunities for growth, challenges and way forward NATIONAL INSTITUTE of Pharmaceutical Education and Research (NIPER), (Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India), will organise a national conference on 'Innovative processes for bulk drugs, enabling the processes of tomorrow,' in Hyderabad on March 26 and 27, 2015. The conference is aimed at discussing the opportunities for growth, challenges and way forward. Reputed industry experts, academicians and policy makers are expected to take part in the conference. The conference will also host vibrant and interactive poster sessions. A subset of the posters will be selected for oral presentations. The conference will have sessions focused on the following themes. They are greener catalysts for pharma processes; development of new pharma strategies and technologies; use of continuous micro reactor technologies; biocatalysts and bioprocesses; process development and scale-up for pharmaceutical products; opportunities and challenges in biopharmaceutical development; advances in quality methods (QBD); impurity profiling; regulatory challenges; process safety in the scale-up; IP landscape in API and generic industries. Speakers who will take part in the conference are Dr AKS Bhujanga Rao, Natco Pharma, Hyderabad; Dr Vaidyanathan Rajappa, Biocon BMS Research Centre, Banglore; Dr Premnath Shenoy, Astra Zeneca, Bangalore; Dr Vilas Dahunkar, Dr Reddy’s Laboratories, Hyderabad; Dr Kaptan Singh, Ran-
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baxy laboratories, Gurgaon; Dr Amol A Kulkarni, NCL, Pune; Dr Raghu V Palle, Biocon, Banglore; Dr MV Suryanarayana, Mylan
Laboratories, Hyderabad; Dr Satish Nigam, Albany Molecular Research, Hyderabad; Dr A Veera Reddy, Suven Life Sci-
ences, Hyderabad; Dr Rakeshwar Bandichor, Dr Reddy’s Laboratories, Hyderabad; Dr S Padmaja, IproPat, Hyderabad; Dr
Srinivas Oruganti, Dr Reddy’s Institute of Life Sciences, Hyderabad. EP News bureau-Mumbai
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MARKET POST EVENT
Sigma Pharmaceuticals’7 annual conference held in Mumbai th
‘Partnering for Purpose’ was the theme for this year's conference THE SEVENTH annual conference of Sigma Pharmaceuticals was recently held in Aamby Valley City. The conference was attended by 315 delegates with over 200 individual businesses represented, together with key pharma suppliers. The theme for this year’s conference was ‘Partnering for Purpose.’ The key messages delivered by all the speakers took advantage of the partnering theme to remind pharmacists about the need to address the all-important issue of patient outcomes. Delegates were advised to stop thinking like shop owners, instead, to be transformed into bona fide healthcare businesses with a professional eye on patient healthcare at its focus. The conference was represented from a wide spectrum of pharmacy and healthcare professionals, ranging from dignitaries like Earl Howe who insisted that pharmacy had ‘undoubtedly turned a corner’ in making healthcare commissioners aware of the role it can play in alleviating the pressure on a strained NHS. Howe went on to say how community pharmacies might consider re-engineering themselves to ensure that their contribution continues to be of direct relevance to the NHS and keeping the best that pharmacy has to offer.” Innovators like Hemant Patel presented the case for ‘Self Care’ pharmacy programmes and how patients could be empowered to work more closely with pharmacy in defining health outcomes based on a self care model
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Delegates during the event
without abdicating from a responsible means of delivering this form of treatment. Kumar Iyer, Deputy British High Commissioner, India, described the relationship between the UK and India as ‘phenomenal’ and insisted that the strength of the partnership was being played out in the pharma and life sciences sectors. He was highly supportive of the work that the UK pharmacy has undertaken so far and conveyed to the conference delegates that the UK government is fully supportive of pharma involvement in India. Sue Sharpe and Mike Dent presented PSNC’s position by reassuring pharmacists that
the negotiating body wants to achieve equality with general practice when it comes to remuneration for services. Dent warned contractors to ensure they get to grips with what he described as 'a much more complicated' funding model than pharmacy has been used to but was adamant that when it came to securing funding, pharmacy would not be left trailing behind the GPs.’ As always, the IPF, headed by Fin McCaul and Claire Ward, were outspoken about their passion to light the fire for change in pharmacy and to inspire the delegates to move forward into a future that is built on the foundation of good service delivery and profes-
sionalism. Claire said, “The future for pharmacy is to put itself in a modern age and to go back to a time when it was at the heart of the community, not simply dispensing medicine.” Salutary messages from
David Cameron, Prime Minister, UK, and Ed Milliband, Leader of Labour Party, were read out. Both commented on the crucial role that pharmacy continues to play in the UK. EP News Bureau-Mumbai
EVENT BRIEF MAY - 2015 05
Respiratory Drug Delivery (RDD) Europe 2015
RESPIRATORY DRUG DELIVERY EUROPE 2015 Date: May 5-8, 2015 Venue: Antibes, France Summary: RDD Europe 2015 will welcome pulmonary and nasal drug delivery experts from around the world. The joint organisers of the event, RDD Online and Aptar Pharma, will celebrate RDD Europe’s 10th anniversary and announce the opening of registration at www.rddonline.com/ rddeurope2015. RDD Europe 2015 will host high-level academic, industry and government experts who specialise in research,
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development and marketing in the field of pulmonary and nasal drug delivery. Contact details: Elisa Eschylle, Events & Press Relations Manager Tel: + 33 (0)1 39 17 20 41 Email: elisa.eschylle @aptar.com
PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000
PHARMA Pro & Pack Expo 2015
pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services and purchase officers. Contact details Indian Pharma Machinery
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iPHEX 2015
IPHEX 2015
being invited to participate in the exhibition. Co-located with PHARMA Pro&Pack Expo 2015, a show for pharmaceutical machinery manufacturers, iPHEX 2015 will offer the industry majors from India and all across the world a great platform to connect and do business.
Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: Pharmexcil with Ministry of Commerce and Industry, Department of Commerce, Government of India will organise iPHEX 2015. Over 400 overseas buyers from focus areas are
Contact details Pharmaceuticals Export Promotion Council of India TV Indl Estate, Unit No. 211, 2nd Floor, 248-ASK Ahire Marg, Worli Mumbai – 400030 Tel: 91 22 24938750 Fax: 91 22 24938822
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cover )
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(
THE MAIN FOCUS
A
LIGHT AT THE END OF THE TUNNEL? The launch of ‘2015 – Year of Active Pharmaceutical Ingredients’ could mark the beginning of a new chapter in the Indian pharma. Industry leaders share their views, apprehensions and expectations on this move BY USHA SHARMA
To subscribe: bpd.subscription@expressindia.com
ctive pharmaceutical ingredients (API) are defined as building blocks of any pharma product or prescription medicine which make it biologically active. Over the years, from the early 1960s upto the early 1990s, many API fermentation plants as well chemical based API manufacturing units have been forced to shut production as cheaper imports made their existence unviable. India thus has become very dependent on imports, often from a single country, for most basic chemicals, intermediates and APIs for many commonly used medicines. After many decades of stagnation, there is hope that this situation might finally be addressed. In recognition of the situation, Department of Pharmaceuticals has declared 2015 as the ‘Year of Active Pharmaceutical Ingredients’ and is due to release a new policy focussing on bulk drugs by this month. Awareness programmes and meetings will be subsequently organised throughout this year at key API manufacturing hubs like Hyderabad, Ahmedabad, Mumbai and Bangalore with state ministers and senior officials from the health, industry and environment ministries of these states along with industry stakeholders. The government has promised to take measures to facilitate the growth of the sector and also interact with the industry on a more regular basis to improve government to business (G2B) interactions and promote better and more coordinated efforts to achieve the objective of the ‘Make in India’ initiative of the Narendra Modi Government, in the contect of the API sector. It is expected that under this initiative, the government will introduce many industry-friendly policies and incentives to give a
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cover ) major thrust to the growth of the bulk drug industry in India in order to make it a formidable force globally. Speaking about the initiative, Dr VK Subburaj, Secretary, Department of Pharmaceuticals said that there is an urgent need to bring about self-sufficiency in the field of APIs. He said that the government is taking steps to reduce dependence on imports and initiate good policy measures to support the industry.
Market size Calculating the size and capabilities of API manufacturers in India, BG Barve, Joint Managing Director, Blue Cross Laboratories informs, “India’s API production was valued at approximately $4.70 billion (` 29,000 crores) in 2012 and India could become the second largest API producer (after China), provided the government supports industry initiatives and works in close collaboration.” He is a member of Indian Drug Manufacturers' Association (IDMA) and on a sub-committee of Bulk Drug
Manufacturers Association (India) (BDMA). According to him, the number of API manufacturers have reduced to 250 from over 600 a few years ago. The Indian API manufacturing industry is the third largest in the world after China and the US. According to EXIM (Export-Import) database, India's API imports have grown at a compound annual growth rate (CAGR) of 18 per cent in the last decade, from a base of about $800 million in 2004 to about $3.4 billion in 2013 across 400 APIs. India depends on China for imports of nearly 80-90 per cent including APIs needed to manufacture Vitamin C, antibiotics — (metronidazole, ofloxacin, livofloxacin). The dependence is much higher in intermediates than APIs, according to Barve. Expressing his concern over extensive imports of API and bulk drugs from China, Anant R Thakore, Chairman, Pharma Vision 2020 Committee opines, “We are heavily dependent on import of infec-
tive bulk drugs (penicillin, cephalosporin’s and macrolides) which are produced through the fermentation route and intermediates for diabetes, pain killers – products like paracetamol.” He concedes that pharma exports from India are more than imports but the concern is that there is heavy dependence on import of pharma intermediates and bulk drugs from a single source, i.e. China. According to Pharmaceuticals Export promotion Council of India (Pharmexcil) data, around 1,600 manufacturer/exporters of bulk drugs are their members but there could be around 15 per cent more such manufacturers who are not Pharmexcil members. India’s imports of bulk drugs during financial year 2014 was ` 19,000 crores.
Tapping the opportunity Various industry associations like Pharmexcil, IDMA, BDMA etc have sent inputs and suggestions from their member companies to the government in order to
help form the bulk drug policy. But will it be out in time to achieve results? Commenting on the feasibility of the deadline, Dr PV Appaji, Director General, Pharmexcil says, “The government has already carried an exhaustive exercise on this subject. We feel it is possible. We expect a comprehensive policy addressing several issues like, infrastructure development, effluent treatment, continuous power availability at low cost, low cost finance, support for technology development, appropriate import / export policies etc.” Barve too seems optimistic about the deadline and says, “It should not technically be an issue, as we understand that the Katoch Committee has submitted their study and made many recommendations.” Policy makers fianlly seem to be awake to the urgency of the situation. Speaking at an industry event, Ananth Kumar, Union Minister of Chemicals and Fertilisers had commented that bulk drugs
'Frequent changes in pricing policy would be counterproductive and restrict longterm growth. The weakening of formulation industry will have a direct impact on the growth of bulk drug industry' Anant R Thakore, Chairman, Pharma Vision 2020 Committee
'The bulk drug policy should at least address the issues that led to increased dependence on the imported materials and encourage domestic production thereof and promote use of indigenous raw materials in the manufacture of APIs/ capabilities but not the infrastructure' DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA)
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'One of the reasons our exports of bulk drugs is affected is undue internal competition. We wish India’s API producers’ may come together to avoid this undue internal competition and expand the spectrum of bulk drugs availability among themselves' Dr PV Appaji, Director General, Pharmexcil
constitute the backbone of the pharma industry and the sector needs to be incentivised so as to take on the challenge from cheap imports. The minster added that there can be no compromise on the quality, environmental requirements or regulatory necessities but the issues hampering the growth of the industry have to be addressed. He also said that over-dependence on imports from one country for bulk drugs is detrimental to the country’s interest and hence, a paradigm shift is necessary. DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) comments critically on the government’s past record of policies for the pharma industry and says, “A lot of preparatory work has been done to help the government to frame the (bulk drug) policy. It is doable. The policy should at least address the issues that led to increased dependence on the imported materials and encourage domestic production thereof
and promote use of indigenous raw materials in the manufacture of APIs.” However, Nipun Jain, Chief Executive Officer, Pharmachem feels, “The government will not be able to frame a policy on bulk drugs in March 2015. And the API industry technically has the skills and knowledge but need extra support from the government.”
Journey so far The Indian pharma industry comprising formulation and bulk drugs has clocked a spectacular growth in the last 30 years. Many small bulk drug units which started in the 1980s and 1990s have become large units today. The general view is that Indian entrepreneurs and technocrats are capable and have expertise to manufacture bulk drugs at a competitive international price provided there is a level playing field. China is in a position to offer bulk drugs at low prices as they have the full support of their government
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by way of subsidised land cost and infrastructure, R&D support, finance at a very low cost, and lax environmental laws. All these factors enable Chinese bulk drug units to sell in India and globally at a low prices. As a consequence, bulk drug manufacturers in India are unable to compete. Jain agrees with his industry colleagues and says, “The Indian API industry has its own strengths as we are very competitive in some segments but the problem lies with the lack of support from the government or you could say hurdles created by different government agencies.” When questioned on the capabilities of Indian bulk drug industry in manufacturing and producing expertise, Barve points out, “Many Indian bulk drug manufacturers comply with all international cGMP guidelines such as US FDA, EU etc and it is a known fact that Indian API manufacturers have the highest number of US DMFs (Drug Master Files) and European
Directorate for the Quality of Medicines and Healthcare (EDQM) CEP applications. A high percentage of India’s API exports are high value, servicing highly regulated markets like Japan, the US and the EU.” But having said this, he concedes, “We have to realise that many more manufacturers, especially in the SME segment, have to be helped with soft finance for technological up-gradation, compliance with WHO GMP, US FDA EU standards etc.” Based on the government's initiative, BDMA has proposed that a series of meetings are to be conducted with the state governments' health and industry ministers, senior government officials and stakeholders at Hyderabad in May/June this year, Ahmedabad (July/ August 2015), Mumbai (September/October 2015 ) and Bangalore (November/December 2015). Listing some other factors which impact the sector, Thakore remarks, “Frequent
‘Indian API has its own strengths as we are very competitive in some segments but problem lies with the lack of support from the government or you can say hurdles created by different government agencies’ Nipun Jain, Chief Executive Officer, Pharmachem
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cover ) changes in pricing policy would be counterproductive and restrict long-term growth. The weakening of the formulation industry will have a direct impact on the growth of bulk drug industry. The concept of market-based price control may continue to encourage industry to continue investing in R&D in novel drug delivery system (NDDS) and dosage forms which will also directly help bulk drug units.”
Maharashtra government must encourage more cluster-based projects by providing state-of-the-art common facilities to help the SME sector to share costs and enhance quality, productivity and innovative capabilities. and to allow expansion of existing units to meet growing domestic and international demands
Leading by example Some states have been more supportive than others. For instance, Maharashtra has been a traditional hub for the pharma industry, both in terms of manufacturing as well as supply of materials. There are around 3,139 pharma units and corporate offices located in the state, with major centres in Mumbai, Thane, Tarapur, Nashik, Aurangabad and Pune. The state also leads in vaccine production and a number of Special Economic Zones (SEZs) have also been notified. Commenting on the potential of the state of Maharashtra, Barve mentions “Many pharma companies enjoy success largely because their major operations are based in Maharashtra. The government support received by the industry has been substantial and the presence of a pragmatic and stable state. The (state) government has been one of the main reasons the state has managed to remain a principal destination for all pharma companies whether domestic or MNC.” But things can always be improved further in Maharashtra as well. As Barve suggests, “The newly set up state government has to take a serious look at a few areas that are hindering the further development of the pharma industry in Maharashtra such as the highly prolabour laws, time-consuming and bureaucratic procedures without adequate facilities, and too many inspections which are expensive for industry in terms of time and money. These can be curtailed and rationalised considerably. Infrastructure
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‘The newly set up state government has to take a serious look at a few areas that are hindering the further development of pharma industry in Maharashtra’ BG Barve, Joint Managing Director, Blue Cross Laboratories
and traffic problems are very acute and progress very slow forcing people to think of other states, which are also more economical in terms of property costs/rentals, cost of living and overall business expenses including wages.” Maharashtra is definitely a more attractive state for the pharma industry and companies will be eager to come back if it offers attractive benefits. The state government must encourage more cluster-based projects by providing state-ofthe-art common facilities to help the SME sector to share costs and enhance quality, productivity and innovative capabilities. and to allow expansion of existing units to meet growing domestic and international demands. It also needs to urgently provide financial and technical support to revive many SSIs that had to close down due to their inability to conform to stringent Schedule M norms, adds Barve. He suggests, “It is now necessary that the Maharashtra government takes more proactive steps to further the growth of this industry by allowing better incentives, tax sops and investment in talent creation.
This will be crucial in order for the industry to sustain its current growth momentum to make sure that the bulk of Indian pharma activity remains within Maharashtra. The Maharashtra government should make all out efforts to encourage the pharma industry to set up manufacturing plants in the state, now that the tax/Excise Duty benefits in states like Himachal Pradesh, Uttarakhand, Jammu and Kashmir etc have been reduced, while at the same time provide tax incentives and subsidies to encourage newer players to enter into the fray and help more established ones to build on their foundations.”
Diligent efforts ... Thakore explains how the SME pharma sector has played a significant role in developing and shaping India’s stature. Many small volumes life saving drugs are produced by SMEs, which are thus cost-effective vital resources of skill, knowledge and employment and have helped reduce prices and increase rural penetration. The irony is that after playing an important role, these units are today fighting for survival. Given this
reality, Thakore feels, “There is a need to upgrade at least 250 units to US FDA / EDQM / TGA and other international standards by 2017. Assured funding at low rate of interest and easy repayment schemes are necessary for upgradation / setting up new units.” Barve explains the state government’s understanding saying, “The government has recognised that the entrepreneur-driven Indian pharma industry is best suited to take our country to the top and hence is in discussions on how to revive the public sector units and how to make better use of their land, manufacturing facilities, personnel etc.” Information available in the public domain shows that Indian pharma exports have slipped slightly in the last one to two years due to various reasons. Appaji explains, “One of the reasons our exports of bulk drugs is affected is undue internal competition. We wish India’s API producers’ may come together to avoid this undue internal competition and expand the spectrum of bulk drugs availability among themselves.” “India’s bulk drug manufacturing expertise is amply
demonstrated over the years. They have helped the formulation industry with its supplies. India has manufacturing capabilities of almost every therapeutic category. Presently, the industry requires assistance in creating huge capacities to compete at international levels and also to help the domestic industry to balance its healthcare expenditure,” points out Appaji. But is the Indian bulk drug industry capable of making the best use of such a policy push? Shah replies, “We have the capability, but not the requisite infrastructure to be competitive.”
… but impact still distant The industry faces many challenges and expects a lot from the Narendra Modi government. Highlighting the industry's concerns, Thakore elaborates, “We stress that Indian manufacturers were at disadvantage on many fronts; from land to cost of money, utility and services. India’s dependence on pharma intermediates and bulk drug can be addressed and India's bulk drug industry can manufacture most intermediates and bulk drugs at competitive prices once issues raised by the IDMA are addressed. Longterm policy for growth of pharma industry should address not only the requirement of large capital intensive plants for manufacturing high volume intermediates and APIs but also small volume intermediates and APIs which are also life saving and important.” Thakore notes down his expectations/recommendations that if the government needs to provide support on some key areas and factors for the industry’s future growth and development: it needs to work on areas such as revival of PSUs, land, finance / banking / working capital, utilities and services /environmental issues and R&D. All eyes are now on the government to deliver on this latest promise. u.sharma@expressindia.com
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INSIGHT
The domestic underpinning of exports: Troubles in the world’s pharmacy
N ISHANT V BERLIA, Member Management Board, Apeejay Stya & Svran Group
A perception has been built up that the ironically hyper-competitive Indian pharma sector is somehow earning windfall profits at the cost of the country’s poor. Nishant V Berlia, Member Management Board, Apeejay Stya & Svran Group argues why the reality is quite the opposite
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ecelerating export growth, an API industry led to waste and a clinical trial industry in the freezer. These are well known concerns to both the industry and government with many initiatives being tried to reverse the slide. Overlooked and perhaps of the deepest concern is the risk of overregulation of the domestic sector and its implications on supply chains. In the past decade, government healthcare spending instead of reaching its own target of three per cent of GDP has fallen to one per cent of GDP whereas private sector continues at three per cent of GDP. We may debate, but one role of the government in healthcare is certainly clear. There are weaker sections of our society for which there is a moral obligation for free healthcare and which only the government can provide for. Equally, however, it is as important to understand that the private sector can only viably supplement not replace the role of the government. Regretfully, a perception has been built up that the ironically hyper-competitive Indian pharma sector is somehow earning windfall profits at the cost of the country’s poor. The converse is, however, very much more of fact. We have the lowest formulation prices of the world, lower even that of in effect our major raw material source, China. Moreover, in a country
The cause is not vanishing profits but the nascent high risk of trying to manage highs and lows of input prices that cannot be passed on. The industry cannot as much control these costs as the government can the price of onions. And add to this the uncertainty of the NLEM which is revised every three years. It is certainly not a recipe for Make in India where modern medicine is still to reach many corners of the country, the industry has played a herculean role of ensuring availability (and at the same price) to every nook and corner of the country.
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In effect, our industry of thousands of molecules/subindustries has created the world’s third largest volume market at the lowest price. It is a natural step for those who have built these domestic sup-
ply chains, to then look to the world. In effect, it is our domestic market that has built and nourishes our export market. And this is why price control, which even China, the
world’s most powerful bureaucracy has announced withdrawal of, remains the Damocles sword over the industry. An idea created as a temporary measure during the 1962 Indo-China War, there has been one inarguable truth about any drug under price control since: stop investment. Whether it is the retailer, stockist, formulation manufacturer, API manufacturer, all will divert resources away. The cause is not vanishing profits but the nascent high risk of trying to manage highs and lows of input prices that cannot be passed on. The industry cannot as much control these costs as the government can the price of onions. And add to this the uncertainty of a list which is revised every three years National List of Essential Medicines (NLEM). It is certainly not a recipe for Make in India. NLEM 2015, which is actually a needed government procurement list, menacingly linked to price controls, will come and go. However, certainly there can be space for de-regulation, especially, if we can allow fertilizer, petrol and diesel de-regulation, arguably even more essential daily to the commons. Formulations remain the only flag left flying high in the pharma sector: let us not sacrifice it and the chances of revival of the API sector on the altar of low government healthcare spending and price control.
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cover ) KIRAN MAZUMDAR –SHAW, CHAIRPERSON, BIOCON
RAJIV GANDHI, CEO AND MD, HESTER BIOSCIENCES
POSITIVE BUDGET, MUST ENSURE IMPLEMENTATION AND DELIVERY
ATAL INNOVATION MISSION WILL FOSTER CULTURE OF INNOVATION
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M’s speech was clear and compelling showing a positive roadmap for the Indian economy.The budget has addressed key needs of both corporate and social sectors. However, I expected more granularity for the implementation of the flagship ‘Make in India’programme.The Skill India, Swachh Bharat and a new fund for start-ups is a welcome move, however, I expected more enabling provisions that would encourage investor funding. The setting up of the Atal
Innovation Mission with an outlay of ` 150 crore is a step in the right direction, but it is more in the nature of modest seed funding to ‘Innovate in India’. The budget does not provide any significant impetus to R&D in the pharma and life sciences. The proposed Universal Social Security System is perhaps the most important reform which I hope in time, will be linked to universal
healthcare. The reduction in corporate tax, commitment to GST implementation, deferment of General Anti Avoidance Rules (GAAR) and easier norms for overseas investors to invest in AIFs are expected to improve the investment climate in the country. Overall the budget is a clear roadmap for investment and growth. However, we must ensure implementation and delivery of all these proposals to take us to the promised destination.
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here are lot of positives in this budget. FM has focused on economic reforms and on reviving the investment cycle in the country. Setting up Atal Innovation Mission (AIM) and earmarking a budget of ` 150 crore will foster a culture of innovation, R&D and scientific research in India. Launching three new National Institutes of Pharmaceutical Education and Research in Maharashtra, Rajasthan and
Chhattisgarh will also give a boost to the R&D in pharma sector. Proposal to reduce corporate tax from 30 per cent to 25 per cent and rationalisation of exemptions along with commitment to implement GST from April, 2016 are welcome steps. All in all, it is a balanced budget.
NITIN GOEL, MANAGING DIRECTOR, IMS HEALTH SOUTH ASIA
BUDGET BLUES SANJAY MURDESHWAR, MANAGING DIRECTOR,ASTRAZENECA PHARMA INDIA LTD (AZPIL)
THERE IS NO DIRECT IMPETUS TO THE PHARMA INDUSTRY
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verall, it is a positive and balanced budget. Increase in infrastructure investments, roll out of GST next year, single window in regulatory processes and phased reduction in corporate tax are steps in the right direction. Even though there is no direct impetus to the pharmaceutical industry, plans announced for the healthcare sector are welcome. Setting up of five
24 EXPRESS PHARMA March 16-31, 2015
new AIIMS across the country will help patients and medical education. Three more National Institute of Pharmaceutical Education and Research will play an important role in bridging the skill gap. The National Skills Mission is an excellent endeavour in this area. Improving accessibility to healthcare has been
stimulated through raise in health insurance premium from `15,000 to `25,000. `150-crore announced for scientific research is a positive move, though incentivising medical/pharma research would have helped trigger more R&D investments into the sector. This is a positive start with more hits and not many misses, it remains to be seen how effectively it will be implemented.
BUDGET HAD VERY LITTLE MEASURES SPECIFIC TO SUPPORT THE GROWTH OF PHARMA INDUSTRY
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he proposal to set up three National Institute of Pharmaceuticals Education and Research is a welcome move from a longterm perspective. However, overall the budget had very little measures specific to support the growth of pharma industry. Considering the low investment in R&D in the sector, specific measures to
incentivise companies on R&D was expected and the budget did not provide any guidance in this direction. Similarly, there have been no initiatives announced to boost the bulk drugs industry which is facing stiff competition from China.
DR HABIL KHORAKIWALA, CHAIRMAN,WOCKHARDT
BREATH TAKING EFFORTBYFM
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ndeed a breath taking effort by Finance Minister Arun Jaitley. It envelops every section of society and commits to initiate social security network for all.
There are measures for global competitiveness and “Make in India’ – a reality.
( SATISH REDDY, CHAIRMAN OF DR REDDY’S LABORATORIES
UTKARSH PALNITKAR, HEAD OFADVISORY AND NATIONAL LEADER OF PHARMA SECTOR, KPMG
RS-150 CR TOO LITTLE FOR INNOVATION FUND
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he budget is a clear one, with a focused growth trajectory for the next threefour years, broadly in line with the expectations of India Inc. The significant outlays on infrastructure of ` 70,000 crores and power projects that will provide a much needed additional 4k MW, are steps in the right direction towards revitalising the investment climate in the economy. While I believe this (the revision in the corporate tax structure) lays out a path for an easier and simplified tax administration in terms of exemptions being rationalised,
we will need to see what the fine print entails on this front. The announcement to implement the GST regime from April 2016 is a good step, which is long overdue. The reduction in the inverted customs duty structure of 22 items will help the ‘Make in India’ initiative of PM Modi and is another positive step in the right direction. The introduction of a bankruptcy law, on the lines of globally accepted norms, will go a long way to streamline business processes and
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THE MAIN FOCUS
NO SPECIFIC IMPETUS FOR PHARMA loopholes, which is what India needs. However, one of the disappointing aspects of an otherwise good budget, was the grossly inadequate outlay of just ` 150 crores on a fund that was announced to fuel innovation. Much more could have been done in this area, especially from a pharma industry perspective, so as to really propel India’s healthcare to a whole new level. This budget provides a lot of clarity and much needed direction and will serve well in setting the agenda for positive growth and ease of doing business.
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ike most other sectors, the pharma sector also had high expectations, more so from the perspective of ‘Make in India’ campaign where the pharma sector has been a shining example of India’s growing dominance. It was expected that specific impetus be given to the pharma manufacturing through announcements of clusters and concession related to taxation related to manufacturing as well as the irritants
such as service tax on clinical trials. As such other than the overall announcement of ‘Health for All’ and creation of NIPER in three states, the budget does not any specific impetus to the pharma sector.” It remains to be seen if further study of the budget yields any good news for the pharma sector.
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MANAGEMENT INSIGHT
Impact of ITon Indian pharma industry
DR SUBROTO GHOSHAL, Manager- Human Resources, Mindteck India
Dr Subroto Ghoshal, Manager- Human Resources, Mindteck India elaborates on the need to improve connectivity between IT and pharma industry for providing better diagnosis and cost effective treatment to patients INDIA IS considered to be the most favoured destination for information technology (IT) companies while Indian pharmaceutical industry is the world’s third largest in terms of volume. Today the pharma industry relies heavily on technology in terms of process management, data analytics, content management, identify cost effective therapy and to engage with the customers. Medical device, which form an integral part of our healthcare system is heavily dependent of software technology. The Indian pharma industry is highly fragmented and has grown enormously in the last 20 years. This industry is highly dependent on science and technology. It is assumed that there are around 24000 players in this segment and around 330 in the organised sector. The organised pharma industry has been growing at about eight to nine per cent annually. India is among the top five pharma emerging markets. There are provisions for phase II clinical trials and new drug launches in the coming year. Continued growth in therapies and expansion in rural market, the Indian pharma industry is expecting a growth of 13–14 per cent. The domestic pharma market is expected to grow because of increasing population of the higher income group. It is estimated that the healthcare industry in India may touch $31.59 billion by 2020. The Indian market for therapeutics and diagnostics is ex-
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REVENUE GENERATED BY IT INDUSTRY
Source: Ibef.org-November 2014
pected to grow inspite of conflict with the US over intellectual property rights (IPR) related issues. Generics will continue to dominate the domestic market while patient-protected products will constitute 10 per cent of the share till 2015, according to Mckinsey report ‘India Pharma 2015 - Unlocking the potential of Indian pharmaceutical market.’ Changes in the business model of the big pharma companies will result in better opportunities for the Indian pharma industry. India has a major advantage of production cost which is almost 50 per cent lesser than that of western countries while clinical trial expense is around one- tenth of the western countries. Budget allocation by the Ministry of Health and Family Welfare has been increased by the Government of
India from `275 billion in FY 14 to `352 billion in FY 15. According to ‘2014 Global life Sciences Outlook’ by consultancy firm Deloitte, pharma sales in India was at $22 billion in 2012 and is expected to touch $ 27 billion in 2016. The opportunity for Indian pharma industry looks greener as 46 US drug patents are expected to expire by 2015. The pharma export has been the lifeline for the growth of this industry but unfortunately 2013-14 has witnessed the slowest growth.
IT & ITeS industry in India The Indian IT and information technology-enabled service (ITeS) sector has enhanced the economic growth of the country. This industry has provided job opportunities to almost 10 million Indians and is the fastest
growing market in the world. India has an edge over other countries due to cost competitiveness in providing IT services. India has a potential to build a $100 billion software product industry by 2025, according to Indian Software Product Industry roundtable (iSPIRT). The India IT-BPM industry is anticipating to add $13-14 billion by FY-2015, according to National Association of Software and Services Companies (NASSCOM). The current estimated size of the industry is about $2.91 billion and is expected to grow to $8.08 billion by 2016. The government has a major role in the development of the Indian software industry. In 1986, Government of India announced a new software policy, which was further enhanced in 1988 with the establishment of
the software technology park of India (STPI) scheme. The government provided foreign equity of up to 100 per cent and duty free import to attract foreign direct investment. The government is trying to promote IT and ITeS sector through various initiatives like launch of Bharat domain name, which will cover eight languages and enhance the reach of the Internet to remote villages. It will launch a series of new initiatives by the Government of Karnataka and NASSCOM to build one of Asia’s largest start up warehouse, extended tax holiday to the IT sector for STPI and special economic zones (SEZ).
IT in pharma industry The major need for IT in pharma industry was felt to decrease the manual work, e-documentation, high competition and less time to reach market. IT is the application of computer and the equipment to inter connect clinicians, prevent medication error, store and retrieve pharma data, data analytics related to the industry or business. The automation of the work process of the pharma industry is the essence of IT system. For the pharma industry, there are various automated IT system available like computerised physician order entry (CPOE), enterprise resource planning (ERP), laboratory information management system (LIMS), customer relationship management (CRM), clinical
trial management system (CTMS), sales force automation (SFA), electronic batch records (eBR) to name a few. Each of the automated application has a specific area of function and helps in storage, maintaining, analysis of data related to the specific function area. Enterprise resource planning or ERP as commonly referred, integrates all data and processes of an organisation. ERP application helps in facilitating the information flow between all the functions of the business. This application works on a macro level and covers modules like production and inventory management, weighing and dispensing, e-batch records, e-packaging records, financial management, human resource management etc. LIMS which is very crucial for any pharma company, manages the information flow within the laboratory. This application helps automate the laboratory process by increasing productivity, efficiency and quality of analysis. This takes care of 70 per cent of laboratory guidelines and help laboratories to implement good laboratory practice (GLP) procedures. Electronic prescribing system (EPS) ensures the system of prescribing, supply and administration of medicines in hospitals where a minor error in medication can have fatal impact on the patient. Currently, very few hospitals have been using this system in India. Barcoding of medicines is being aligned with electronic prescribing system and has been effective in reducing medicine administration error and improve completeness of medication history. A new falsified medicine directive (FMD) is being planned for implementation in 2017, for unique identification of medicines at the point of dispensing in order to restrict counterfeiting. Mobile technology is widespread and used at different levels. Apart from reminder alert to patients, sophisticated application have been developed for disease monitoring like peak flow reading in asthma, blood glucose level, medication adherence support and health education.
The power of social media and the impact it has on the customer has been realised by the pharma companies. The pharma industry is bound by strict marketing and FDA regulation, but some of them are trying to build new forum to get associated with the customers Medical information in pharma industry The primary role of medical information department in a pharma and medical device company is to address the queries about the company’s product. Medical information system’s purpose is to provide customer support, inquiries and response. The team for this in most companies consists of doctors of pharmacy, nurses, MDs, Ph.Ds and other life scientists. The reason for this is the team have scientific and medical training to handle medical information and interact with the healthcare providers. The information is provided through call centres and content developers. In certain cases this category of service falls under ITeS and depends heavily on technological support in medical field. Medical information is largely a customer and practitioner integrated department in the area of biotechnology, pharma and medical device companies. A variety of software applications are available to empower medical information team to support patients with healthcare professionals and this system still continues to evolve.
Technology in medical devices Medical device have become an integral part of our healthcare system. These devices are based on high technology medicalbased software application. As per World Health Organization (WHO), there are around 1.5 million medical devices available in the global market starting right from low cost thermometer to sophisticated devices like MRI and chemotherapy machines. Globally, the medical devices today are based on wireless communication technologies
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such as Bluetooth smart and IrDA which are connected to smart phones, tablets, computers and other medical devices. Advancement have been made in India on the various medical device front. Mobile hand held devices are being developed in India where a device can monitor blood sugar level, pulse rate, blood pressure, oxygen level of a patient in remote area and can transmit the same to the healthcare service provider or practitioner to enable quick treatment support. This is based on integration of wireless technology in medical device which is remote patient monitoring (RPM) and medical body area network (MBAN). Today, there are a few downloadable applications available which can be used to activate and run medical device connected to the computer thus taking the innovation to a new horizon. The development of microprocessor, memory cards and miniature electronic circuits have motivated the pharma and medical device companies to innovate small medical device which can be carried in the pocket as well.
Trend in the technology for future pharma industry The pharma industry is seeing a shift in the pattern of their operations. Many collaborations are being witnessed in this sector like Israel-based Teva pharmaceuticals in collaboration with Procter and Gamble plans to set up OTC medicine facility while Eli lilly and Strides Arcolab had inked a pact to deliver cancer medicines in emerging markets. The change in the patient behaviour with healthcare professionals and emerging technologies are creating new opportunities for collaboration and is having impact on the future of the
pharma industry. Pharma companies have started focusing on the locationbased capabilities and wide scale use of smart phones to engage with patients and provide them useful service with the aim to improve the quality of life. Pharma companies are now understanding the need and utility of ‘Big Data’. For this industry, the data comprises of electronic medical records (EMR) coming with genomics and genetic data, financial data and patient data to get details of which therapy provided high value at lowest cost to the patient. This data is crucial for healthcare reforms. Earlier, data used to be in silos but with the advancement of technology, data is now shared with the objective to find new opportunity and unlocking far more potential. This data helps R&D organisation to use in multiple outlets including research laboratories, contract research organisation and for academic purpose. This industry is also migrating towards cloud market to meet the requirements of life sciences. Cloud market has been mostly used for sales and marketing within the pharma companies but now it is being explored to overcome IP issues, security issues and to reduce the operational cost. The power of social media and the impact it has on the customer has been realised by the pharma companies. The pharma industry is bound by strict marketing and FDA regulation, but some of them are trying to build new forum to get associated with the customers. An example of this is Sanofi, which has experimented with social media by building Facebook community for diabetes patient who share their experience with the
disease. This helps in improving and have focus on the health and wellbeing of the patient and build the company’s image as a responsible service provider for the society.
Peek into the future The pharma industry is experiencing a paradigm shift with IT advancement. Multiple range of systems are available to support the work flow and they should ensure to harness the technology for industry’s growth. New technology will play an important role in the pharma industry with respect to utilising data analytics to identify best targeted and cost-effective therapy or using social media to get connected with the customers. In India, healthcare has been heavily urban based. The rural area has been under privileged and the pharma industry has not been too aggressive in penetrating into this area. However, today, the focus of the industry is changing, realising the potential of rural India pharma market. It has been realised that with the IT, rural sector can be served much better giving a boost to countries economic growth. India will not reap its full success in information technology and pharma industry unless it creates opportunities for local community and rural area. Players who adopt and innovate will be successful in the long term.
Reference 1.Arisglobal.com/uploads/2014/04/medical-information-role-in-pharmaceutical-industry-2014. 2.ASA & associates LLP; A brief report on pharmaceutical industry in India, May 2014 3.Ibef.org/industry/informationtechnology-india.aspx 4.India healthcare industry report:2014, Emerging markets direct report; July 18.2014 5.Industryweek.com/emergingtechnology/six-tech-trends-will-shapepharmaceutical-industry-2013 6.Marketresearch.com/indiahealthcare 7.Pharmaceutical-journal.com/publication/focus-community/11134174.article 8.The increasing importance of software in medical device by Mitch Posada, March 3, 2014
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MANAGEMENT REPORTS
Growth hormone therapy market favours biobetters over biosimilars GlobalData analyst states that long-acting GH biobetters will have an increased chance of market uptake upon entry THE LACK of biosimilars in the growth hormone deficiency (GHD) treatment pipeline does not signify a missed opportunity, because superior products exist in the form of next-generation biologics known as biobetters, says an analyst with research and consulting firm GlobalData. According to Lakshmi Dharmarajan, anaylyst, GlobalData, covering cardiovascular and and metabolic disorders, all the drugs currently in latestage development for GHD in the seven major markets, namely the US, France, Germany, Italy, Spain, the UK and Japan, are long-acting growth hormone (GH) drugs, or GH
biobetters. Dharmarajan explains, “Despite the patent expirations of the originator drugs, there are no biosimilars in the GHD treatment pipeline. Instead, long-acting GH biobetters will have an increased chance of market uptake upon entry, as they address the unmet need for improved compliance while offering a clinical advantage over their predecessors.” “Additionally, biobetters can be approved through the established regulatory pathways, whereas the biosimilar guidelines are still somewhat murky. While GH biobetters require more time and investment for development, the net
Biosimilar manufacturers must make a substantial investment comparable to that for the originator drugs in order to build their brand value
payoff is higher when they are marketed due to their premium pricing.” On the other hand, high biobetter prices could facilitate the adoption of GH biosimilars, because these products are expected to significantly reduce treatment costs. However, the analyst cites the case of Sandoz’s Omnitrope, the only currently-marketed GH biosimilar, as evidence that drug uptake in this treatment space relies on more than just price and is influenced by factors such as delivery options, patient assistance programs, and company rebates to payers. Dharmarajan continues:
“Omnitrope was the first biosimilar to be approved in the global pharmaceutical space and despite having a 30 per cent lower price than Pfizer’s Genotropin (somatropin [rDNA origin]), the drug initially failed to penetrate the GHD treatment market. The analyst concludes that to compete in such a market, biosimilar manufacturers must make a substantial investment comparable to that for the originator drugs in order to build their biosimilar brand value, a risk that only the larger pharma companies can afford to take. EP News Bureau-Mumbai
Big Pharma drives innovation in pain therapy development, despite declining patent applications Patent applications for pain treatments between 2008 and 2012 were dominated by Big Pharma, including Sanofi, Novartis and Merck & Co PATENT APPLICATIONS for novel pain therapeutics declined steadily in number from 4,970 in 2008 to 3,492 in 2012, an average annual decrease of eight per cent, as limited understanding of pain pathophysiology continues to hinder drug development in this arena, says business intelligence provider GBI Research. The company’s latest report states that patent appli-
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cations for pain treatments between 2008 and 2012 were dominated by Big Pharma, including Sanofi, Novartis and Merck & Co. (Merck), which submitted 169, 162 and 142 applications, respectively. However, according to GBI Research, the global pain treatment market is dominated by opioids and steroidal anti-inflammatory drugs, with no novel products currently able to challenge these prod-
ucts’ efficacy in treating moderate to severe acute pain. Furthermore, despite the significant unmet needs for more effective therapies in other pain subtypes, such as chronic and neuropathic pain, due to their rising prevalence, the factors underpinning these subtypes are complex and poorly understood. However, this limited knowledge is being countered by technological advances and
significant research efforts, with new insights translating into an expanding pool of novel therapeutic targets. GBI Research states that the overall pain therapy pipeline is exceptionally large and moderately diverse, with a number of molecules boasting different mechanisms of action to those seen in the current market landscape. This offers a high probability of producing strong market entrants in the near future. Indeed, among the 111 firstin-class pipeline products available for strategic consolidations, some have shown promising preclinical evidence and significant poten-
tial to become game-changing treatments, representing high-reward investments. GBI Research believes that such innovation in the pain therapeutics field is being driven primarily by Big Pharma, due to the large number of patent grants awarded to these companies for their treatments between 2008 and 2012. Merck boasted the highest number of patent grants during this period, with 59, while Boehringer Ingelheim and Allergan achieved 35 and 34, respectively, and Sanofi and Novartis both achieved 30. EP News Bureau-Mumbai
RESEARCH CLINICAL UPDATES
BIOTRONIK BIOLUX P-I clinical study results published
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LABORATORY DESIGNED AS PER GLP AND ENSURES DATA INTEGRITY AND SECURITY. THE RESULTS of BIOTRONIK BIOLUX P-I clinical study have been published in Journal of Endovascular Therapy. This was announced by BIOTRONIK, manufacturer of cardioand endovascular medical technology BIOLUX P-I was a prospective, international, multi-centre, first-in-human, randomised, controlled trial that enrolled 60 patients at five centres in Germany and Austria. The study assessed the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) in treating de novo and restenotic femoropopliteal lesions, and the positive results were instrumental in gaining CE mark in December 2013. Data collected at six and 12-month intervals demonstrated that patients treated with Passeo-18 Lux DCB were less likely to require treatment again. At six months, patients treated with the Passeo-18 Lux DCB had a significantly lower late lumen loss (LLL) (0.51Âą0.72 vs. 1.04Âą1.00; p=0.033) and binary restenosis rate (11.5 per cent vs. 34.6 per cent; p=0.048) compared to
the control percutaneous transluminal angioplasty (PTA) treated patients. Correspondingly, clinically-driven target lesion revascularization (TLR) was lower in the Passeo-18 Lux DCB group at 12 months (16 per cent vs. 52.9 per cent; p=0.020) for the as-treated population. In addition, patients receiving treatment with Passeo-18 Lux showed greater improvement in Rutherford class compared to baseline (72.0 per cent) versus those receiving treatment with PTA (65.2 per cent). The results of the study are being used by BIOTRONIK as a foundation to further investigate Passeo-18 Lux in real world populations, such as the BIOLUX P-III All-Comers Registry, which is currently enrolling patients in Europe and Asia Pacific. Results from BIOLUX P-I are in line with other scientific data, suggesting that treatment with DCB is a viable option and has the potential to become the standard for treating femoropopliteal arteries. EP News Bureau-Mumbai
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RESEARCH
New streamlined system for research ethics review launched in Ontario System provides nimble, efficient review of multi-centre clinical trials, while maintaining highest ethical standards A NEW ‘streamlined’ approach for the ethical review and oversight of multi-centre clinical trials in Ontario was launched by Clinical Trials Ontario (CTO). The CTO Streamlined Research Ethics Review System allows any single ‘CTO Qualified’ research ethics board in Ontario to provide ethical review and oversight on behalf of multiple research sites involved in a clinical trial. The current approach in Ontario has been to conduct a research ethics review at each and every research institution participating in the same clinical trial. “The CTO Streamlined System provides a timely, efficient and effective approach for reviewing multi-centre clinical research in Ontario, while maintaining the highest standards for participant protec-
tion,” said Susan Marlin, President and Chief Executive Officer, CTO said at the launch of the new system. A stakeholder-led organisation established by the Government of Ontario in 2012, CTO has been working with the clinical trials community over the past two years to design and build the CTO Streamlined System. Reza Moridi, Minister of Research and Innovation, Ontario said, “Ontario is an ideal location for clinical trials because of our leading researchers and clinicians, established networks and high-quality research infrastructure. Now, with a new streamlined approach for ethical review and oversight, Ontario will be an even more globally attractive place to conduct clinical trials.” Clinical trials play a crucial
role in advancing medical knowledge, enhancing the health of Ontarians and advancing our innovation economy through direct investments in research facilities and job creation. The Council of Academic Hospitals of Ontario (CAHO),
which represents the province’s 24 research hospitals, added its voice of support and partnership at the launch. The CTO Streamlined System can be used for both industry-sponsored and investigatorinitiated multi-centre clinical trials and health research. All
research ethics boards participating in the system are ‘CTO Qualified’ through the CTO REB Qualification Program. This programme provides an external review of their governance, membership, operations and review procedures. The qualification process is important as it allows institutions and research ethics boards to feel confident delegating ethics review and oversight to each other. In recent months, several research ethics boards in Ontario have become CTO Qualified. One of those boards is already reviewing a newly-submitted clinical trial protocol. Facilitating the process is a web-based electronic platform called CTO Stream. EP News Bureau-Mumbai
RESEARCH UPDATES
US FDAapproves Astellas drug for invasive fungal infections Astellas expects to begin selling the drug in the coming months US HEALTH regulators approved Japanese drugmaker Astellas Pharma drug for the treatment of two rare, often fatal invasive fungal infections that target patients with blood cancers. The Food and Drug Administration approved sale of the anti-fungal drug, Cresemba, for use against invasive aspergillosis and invasive mucormycosis. The approval had been expected after an expert advisory panel to the FDA in January voted 11-0 that Astellas had demonstrated sufficient safety and efficacy to support Cre-
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semba for aspergillosis and 8-2 for mucormycosis. The panel cited the need for additional treatments. In clinical trials, the drug, also known as isavuconazonium, proved at least as safe and effective in reducing mortality as voriconazole, which Pfizer sells under the brand name Vfend, the current standard of care for aspergillosis. “Today’s approval provides a new treatment option for patients with serious fungal infections and underscores the importance of having available safe and effective antifungal
Cresemba is also being tested against another serious fungal infection called invasive candidiasis
drugs," Edward Cox, head of evaluation of antimicrobial products for the FDA, said. Cresemba received a Qualified Infectious Disease Product (QIDP) designation from the agency, which is used as an incentive to spur development of antibacterial or antifungal drugs that treat serious or lifethreatening infections. The designation comes with an additional five years of marketing exclusivity. Astellas expects to begin selling the drug “in the coming months,” said Jim Robinson, head of the company's US op-
erations. Invasive aspergillosis is a rare, life-threatening fungal infection seen predominantly in patients with compromised immune systems, such as those with leukemia. Mucormycosis is a very rare, rapidly progressing invasive fungal infection also with high rates of morbidity and mortality. Cresemba is also being tested against another serious fungal infection called invasive candidiasis, Robinson said. That would address a larger patient population than the two infections in the initial approval. Reuters
RESEARCH
Neuropsychological, neuropsychiatric help follow course of Alzheimer’s disease
Novartis wins approval for first US biosimilar drug
Difficulties in cognitive performance were not linked to behavioural and psychological problems
The move had been expected after Zarxio, which is made by Novartis' Sandoz generics unit, won unanimous backing from an FDA panel in January
THE COGNITIVE performance of persons with Alzheimer’s disease (AD) and behavioural and psychological problems are linked to their performance of activities of daily living, according to a recent study completed at the University of Eastern Finland. However, difficulties in cognitive performance were not linked to behavioural and psychological problems, although both deteriorated as the disease progressed. Some persons may have significant problems in memory and other cognitive performance without the presence of behavioural and psychological problems, while others experience behavioural and psychological problems already at the early phase of the disease. Diseases causing dementia are becoming increasingly common as the population ages and life expectancy increases. AD is the most common cause of dementia, leading to progressing problems in memory and other cognitive performance. AD is also associated with
deteriorated performance of activities of daily living, and increased need for assistance. Furthermore, AD is often associated with behavioural and psychological problems. Information on the progression of the disease and its evaluation methods is needed for treatment planning and for the evaluation of treatment outcomes. The PhD thesis of Ilona Hallikainen focuses on the progression of Alzheimer's symptoms after diagnosis, and sheds new light on the usability of the CERAD neuropsychological test battery in the monitoring of the progression of the disease. The study was a threeyear follow-up of 236 persons with AD and their caregivers from three Finnish hospital districts. The study constituted part of the multidisciplinary ALSOVA study coordinated by the Institute of Clinical Medicine (Neurology) at the University of Eastern Finland. During the follow-up, difficulties in cognitive performance and activities of daily living as well as behavioural and
psychological problems and the severity of the disease increased; however, approximately 50 per cent of the study participants were diagnosed with a mild form of Alzheimer’s disease after the three-year study period. An interesting observation was that persons who at the onset of the study were diagnosed with a very mild form of AD and whose treatment had begun at the early phase experienced a slower decline in the performance of activities of daily living and less frequent presence of behavioural problems. The study sheds new light on how the disease progresses in persons under current treatment. The CERAD neuropsychological test battery is widely used in the early detection of Alzheimer’s disease. The study discovered that the test battery's total score was a wellfunctioning measure in followup use. In clinical use, however, the use of the CERAD test battery for the monitoring of ADrelated symptoms may be limited due to it requiring plenty of time. In the test battery, tasks assessing global cognition, language, visual perception and executive function were found to be very useful in follow-up use. Although memory problems are first signs of the disease, the role of other cognitive deficits increases as the disease progresses. The results open up new possibilities for the monitoring of the disease both in research and in clinical settings. The findings were originally published in Dementia and Geriatric Cognitive Disorders EXTRA and International Psychogeriatrics. EP News Bureau-Mumbai
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US REGULATORS gave a green light to sales of the country’s first ‘biosimilar,’ or copied version of a biotechnology drug, by approving Novartis’ white blood cell-boosting Zarxio. The drug contains the same active ingredient as Amgen Neupogen, or filgrastim, which generated 2014 sales of $1.2 billion worldwide. The Food and Drug Administration said it approved Zarxio for the same five conditions for which Neupogen is used - preventing infections in cancer patients undergoing various treatments. The move had been expected after Zarxio, which is made by Novartis' Sandoz generics unit, won unanimous backing from an FDA panel in January. Biosimilars have been available in Europe since 2006. Health insurers have said biotech drugs with expired patents should also face lower-cost competition in the US, leading to savings in the same way generic versions of conventional medicines have cut prescription costs. The FDA, however, only received the authority to approve biosimilars with the passing of the Affordable Care Act, also known as Obamacare, in 2010. Biological medicines, whose price tags can run into tens of thousands of dollars per patient per year, account for about 30 per cent of US drug spending. Unlike chemical compounds, such as aspirin or statins, biotech drugs are made inside living cells, and tiny variations are inevitable, depending on the exact production process. As a result, a copycat version
The Food and Drug Administration said it approved Zarxio for the same five conditions for which Neupogen is used can only ever be similar to the original, rather than identical. One technical uncertainty with a biosimilar is its official generic name, an important point for pharmacists filling prescriptions. The FDA said Zarxio would, for now, carry the hyphenated name “filgrastimsndz” while the agency works on a comprehensive naming policy. In a statement, Amgen said it believed Neupogen, with a wholesale price of $315 for the lowest packaged daily dose, "continues to have an important role to play in helping patients." Sandoz declined to specify Zarxio's pricing ahead of the US introduction. Amgen has sued to block Zarxio. Sandoz previously agreed to delay its US launch until a court decision on Amgen’s request for a preliminary injunction, or until April 10, whichever comes first. Reuters
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RESEARCH
Strong link found between adolescent obesity and high blood pressure The association of BMI to blood pressure was more pronounced in females than males A RECENT study published in the American Journal of Hypertension has found that body mass index (BMI) in healthy adolescents has a statistically significant association with both systolic blood pressures (SBP) and diastolic blood pressures (DBP), and highlights the significance of the global trend of rapidly increasing adolescent obesity. The study, led by Yaron Arbel, Department of Cardiology, Tel Aviv Medical Center, examined 715,000 Israeli adolescents, both male and female, aged 16-20, who had received medical exams from 1998-2011. There was a statistically significant link observed between BMI and blood pressure, both of which saw significant annual increases during the study. The percentage of overweight adolescents in-
creased from 13.2 per cent in 1998 to 21 per cent in 2011, while the percentage of adolescents with high blood pressure (SBP > 130mmHg) rose from seven per cent to 28 per cent in males and two per cent to 12 per cent in females.
The association of BMI to blood pressure was more pronounced in females than males. While the reason for this is not immediately clear, researchers hypothesized that it may be attributable to certain hormonal factors.
“An important finding in our analysis is that BMI was positively associated with SBP and DBP in both the normal weight and overweight groups,” says Arbel. “This highlights the importance of BMI as a marker for cardiovascular health in all body types.” Arbel feels that the study highlights the need to address childhood obesity and said, “Obese youth are more likely to have risk factors for cardiovascular disease, such as high cholesterol or high blood pressure. They are much more likely to be obese as adults and are consequently more at risk for adult health problems such as heart disease, type II diabetes, stroke, numerous types of cancer, and osteoarthritis.” EP News Bureau-Mumbai
Prenatal blood tests detect cancer signal in some women A NEW genetic test that sequences the blood of pregnant women for signs of diseases such as Down Syndrome in their fetuses are turning up unexpected results: a diagnosis of cancer in the mother. In as many as 40 cases, women who took Sequenom Inc's MaterniT21 test, which scans their genetic code and that of their foetus, had abnormal changes that could signify cancer. In at least 26 of these women, that test turned out to be accurate. Such tests from Sequenom and other companies, se-
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quence the mother's blood, which includes both the mother’s DNA and foetal DNA from the placenta. The unintended detection of disease lends weight to the idea that some cancers can be traced through non-invasive tests, when tumours shed their DNA into the bloodstream. Dr Eunice Lee, 40, a San Francisco anesthesiologist, was one of those women. Speaking at the Scripps Future of Genomic Medicine Conference, Lee said she was hoping for a normal result for her baby. Instead, Sequenom
advised her to seek cancer screening. A full body MRI identified a large tumour in her colon, which doctors removed in the 15th week of her pregnancy. Sequenom’s chief scientific officer, Dr Dirk van den Boom, said the company is gathering data on the other women whose tests indicated abnormalities. So far, he said he is not aware of any false positive results. Other researchers have had similar findings. Scientists at the University of Leuven in Belgium developed a blood test for signs of
Hodgkin’s lymphoma after detecting the illness in pregnant women. Most often, DNA from the mother comes from bone marrow, but if she has cancer, it may also be coming from her tumour. Such results are raising ethical concerns. Lee said she was not told that the test might identify a cancer. Van den Boom said the company has struggled about what to do with such results, but favors disclosing the information. Reuters
CTI BioPharma’s blood cancer drug meets studygoal CTI BIOPHARMA Corp's experimental blood cancer drug achieved the main goal of a late-stage study, but at least two analysts said the pill would not directly compete with Incyte Corp's treatment. CTI BioPharma said its pacritinib significantly reduced the size of the spleen in patient's suffering from myelofibrosis, a form of blood cancer that makes the bone marrow produce too much of any type of blood cell. UBS Investment, Research analysts also said CTI's drug was not a direct threat to Incyte's Jakafi, the only treatment for myelofibrosis to be approved by the US Food and Drug Administration. A second late-stage study would determine how well pacritinib would compete with Jakafi, Janney Montgomery Scott's David Lebowitz said. Jakafi, approved in November 2011, generated $357.6 million in revenue last year. Baxter International bought the rights to sell pacritinib in November 2013. Nearly 18,000 patients are estimated to live with myelofibrosis in the US, CTI said. The differentiating factor between the two drugs was that patients whose platelet counts went down, a condition called thrombocytopenia, responded to pacritinib. CTI said its pill was significantly better than the "best available therapy" prescribed by patients' doctors. The therapies, however, did not include JAK 2 inhibitors. Jakafi and pacritinib belong to a class of cancer-fighting drugs called JAK inhibitors, which disrupt production of a protein key to regulating the immune system and contributes to the growth of cancer cells. Pacritinib brought down spleen size by 35 per cent, CTI said but did not disclose in how many patients. Jakafi had achieved the same target in 45 per cent patients in its late-stage study. Reuters
RESEARCH
Micro-nutrient beauty therapy helps prevent ageing on skin: Study The double blind placebo controlled study conducted involved 80 healthy women aged 35-55 years A CLINICAL trial conducted by University Hospital of St Jacques, Besançon (France), Europe’s oldest medical institutes dates back to 1182, which shows that micro-nutrient beauty therapy can help prevent ageing effects of harsh climatic variations on the skin. The results of the double blind placebo-controlled clinical trial represent the world’s first discovery that oral micronutrient therapy can protect against the negative structural changes in the skin caused by climatic variations. Climatic variations contribute to skin ageing, roughness, reduced skin thickness and elasticity, making the skin ageing visible. “Appropriate micronutrient therapy can ensure an adequate supply of nutrients to the body, thereby slowing the aging process, enhancing the appearance of the skin & helping overall wellbeing,” said Prof. Philippe Humbert, Head of the Department of Dermatology at the University Hospital of St. Jacques of Besançon (France). Prof. PhilippeHumbert is also the world renowned leading expert on skin analysis. The double blind placebo controlled study conducted involved 80 healthy women aged 35-55 years. Two tablets of Perfectil were given once daily for four months. Clinical trial showed significant increase in skin roughness and micro relief (an indicator of fine lines) in women who did not take the supplement, compared to a consistent protective effect in those taking Perfectil. For all roughness and micro-relief indicators, there was a significant increase from baseline to month four in the placebo group (p<0.05) but no change in the supplement group.Highfrequency ultrasound on exposed skin revealed that skin thickness was significantly decreased in the placebo group but was stable in the Perfectil group (p<0.01). The researchers found that: ◗ Women who took the supplement were protected against a marked dete-
Prof. PhilippeHumber
rioration in skin micro-relief or volume of fine lines (p<0.01) which was 2.5 times increased in the placebo group compared to Perfectil group. ◗ Increase in skin roughness (Rt) in the placebo group (p<0.01) was found to be double than those in the Perfectil group. ◗ Significant adverse changes were also reported in Viscoelasticity (p<0.01) and skin thickness (p<0.01) in the group not taking the supplement. After few months of Perfectil therapy, women could experience improvement in skin texture, marked deterioration in face wrinkles and a younger look. “The positive results of this trial show that women who wish to protect their skin against seasonal changes should consider Perfectil,” added Humbert. Humbert, said, “These supplements are not gender specific. Both men and women are eligible to consume the supplements.” In India, Meyer Organics has been licensed for introducing this micro-nutrient therapy, Perfectil, to combat the negative effects of seasonal variations on Indian population to rejuvenate body, help to slow down the aging process. EP News Bureau-Mumbai
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‘Our vision at Navitas is to be the best knowledge company in the Life Sciences R&D space’ Information technology has become a crucial part of pharma industry helping it streamline itself. TAKE solutions has recognised this need by launching a new business arm. Srinivasan H R, Vice-Chairman and Managing Director, TAKE Solutions enumerates future plans in an interview with Shalini Gupta
Why did TAKE solutions launch Navitas? You were servicing life science clients earlier as well. With Global IT spends by pharmaceutical sector estimated at 3.4 per cent of their annual revenue, Regulatory Information Management market (Products & Services) estimated at $1 billion and Clinical Data Management (Products, Services & Technology) at approx. USD 3-4 billion, we are looking at a mammoth market with a scope for immense growth. The complexity of data and process is unique to pharma industry. This is where we have implemented our deep subject matter expertise, technology solutions, and business services enabling customers to swiftly and reliably move towards a unified approach of combining strategy and expert advice with efficient operations, empowering them to be compliant while being competitive. Our products, solutions and business services have resonated well with customers, enabling them to address needs within the R&D as well as the commercialisation areas. This encouraged us to
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make the strategic decision of creating a wholly-owned subsidiary of TAKE Solutions called ‘Navitas’ in order to capitalise on our strengths in this domain. Our move to create a new brand is to meet the demand of this market for a niche player, in time to emerge as a competent and differentiated brand. Navitas, a pure-play life science solutions company, is a result of our new go-to market strategy. With the launch of Navitas, we can truly call ourselves as domain experts in the areas of clinical, regulatory, safety and compliance. We pride ourselves on our industry insight, our simplification approach and our pragmatic solutions. What is the vision for Navitas? Would the services/offerings remain the same or have you restructured/repositioned them? Our vision at Navitas is to be the best knowledge company in the life sciences R&D space by delivering the products, knowledge process outsourcing services and domain consulting expertise that the position entails. Navitas comprehensively covers consulting,
technology, and outsourcing (functional services) across the clinical, regulatory, safety, and quality/ compliance functions for the life sciences industry.
We pride ourselves on our industry insight, our simplification approach and our pragmatic solutions
What percentage of TAKE’s total revenues comes from life sciences annually? By how much has the business been growing Y-o-Y? As of the quarter ended September 30, 2014, 61 per cent our revenues came from life sciences. There is a demand in the global pharma/life sciences market for regulatory compliance and customised solutions to meet business needs. The total addressable market of the life science industry is valued at $15.9 billion. How have your services/ offerings changed with the growth in the life sciences industry? Which are most preferred services business wise contributing to the revenues? We have always believed in deep subject matter expertise in life sciences and all our investments to date reflect our vision of being a comprehensive and a global collaborative partner to the bio-pharmaceutical and medical device industry. The
growth in the industry has only highlighted the challenges of sustainable revenue growth with better margins against the backdrop of an increasingly stringent global regulatory regime. Navitas provides a very unique top down CxO advisory supported by collaborative industry networks. We guide our customers through change management, governance, process overhaul and organisation redesign and keep the industry well informed and hand hold them through transformations. We have adequately complemented this capability with organic technology offerings coupled with strategic partnerships with enterprise software companies. We have a service enablement capability which is very operational oriented and provides high quality and cost effective, value-added outsourced services, as evidenced by our ‘industry first’ accomplishments of unit pricing per deliverable and other significant efficiency metrics. We are quite clear that this unique approach to solving problems is essential and we will be attempting to grow them all and contribute
equally to our revenues. How has the slump in the clinical trial industry affected business? We are not witnessing a slump in the global clinical trials industry. On the contrary, we are seeing a surge. If this question is to specifically address the situation in India, we are currently not participating in the Indian clinical trials market. We are monitoring the developments closely and are well prepared to participate in the Indian market when the situation warrants it. In fact, we are very well branded in the Indian market due to our flagship software portfolio, PharmaReady, that enables regulatory document management, document and submission publishing (electronic and paper), submission registration, tracking, and management as well as other content management solutions. We have also been very busy implementing drug safety systems, CAPA, QMS, and Track & Trace systems for our customers in India and the region. We are well poised in mind and market share to partner with our customers in their clinical trials area when the opportunity
Our vision at Navitas is to be the best knowledge company in the life sciences R&D space by delivering the products, knowledge process outsourcing services and domain consulting expertise that the position entails. We are not witnessing a slump in the global clinical trials industry. On the contrary, we are seeing a surge resurfaces in India. Are Indian companies and MNC pharma utilising pharmacovigilance services? Yes, it is mandatory for all companies without exception to be accountable for safety, adverse reactions or any other issue relating or subsequent to the launch of a drug. This accountability is a necessity and not an option.
accurate. As a business enabler and solution provider, the target of Navitas is to provide datarelated service and derive inferences from the existing content given by the sponsor company. We are specialists in interpreting data and results to enable submission. It is not in our place to make judgments, challenge or determine the veracity of this data.
Pharma companies globally have been in the red for drug safety violations and fudging clinical trial data. How, then, do you think companies such as yours and the services you provide can be counted as reliable? Firstly, to place all pharma companies under this bracket is not fully
What technologies do you see as futuristic in the areas that you serve? We are already working on the next generation of cloud-based regulatory IT tools that will radically change the way regulatory information is managed in the next several years. Technologies that would help support data transparency
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and collaboration as well as predictive analytics will drive the future. Real world evidence and outcomes based treatments will increasingly become the norm, and there will be a surge in the design of new and novel clinical trials that will produce more effective and safe drugs and procedures aimed at personalised medicine. We are currently engaged in pilot exercises aimed at analysing Drug-ADR (Adverse Drug Reaction) cooccurences for a more effective and timely signal detection and management methodology. Upon scaling across several thousand drugs, this data could also be utilised for drug-drug interaction analysis, off-label usage of drugs, substance misuse, unmet clinical needs
and better design of clinical trials and patient recruitment strategies and several more use cases. We are encouraged by the initial findings and hope to scale this platform using the Hadoop infrastructure and launch specific B2B and B2C solutions and services. What role do you see technology providers such as yours playing in the life sciences industry in the future? What would/does make you indispensable? Navitas is not a mere technology company. It is a business enabler that has the ability to view the niche domain it operates in differently, thus delivering better outcomes for the pharma/biotech industry in the form of lowered costs and faster time to market. What are the future plans? By how much do you see Navitas growing by? Going forward, we are going to invest more in developing critical IPs, delivering products/services that lower the costs and time to market for our sponsor companies. We envisage a CAGR of 25 per cent for Navitas. shalini.g@expressindia.com
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‘Technology can help reduce the cost of drugs’ Sandeep Lodha, Vice President, Sales and Marketing, Tyrone Systems talks about importance of HPC (High Performance Compute) to the pharma industry, in discussion with Sachin Jagdale
Explain HPC (High Performance Compute). Do pharma companies require to make special arrangements/infrastructu re for the same? HPC is interchangeable word with super computers generally. These are used for computation of large data in parallel to do the necessary work in shorter period of time. It is usually used either for running complex simulations or computations. Pharma companies opt for a dedicated HPC infrastructure if they think they can ensure optimal utilisation. But this is not always the case. There are specialised on cloud HPC services, such as Tyrone Edra that can be used by pharma companies almost as if it is their own but on a pay per use basis. How will HPC speed up the drug discovery process in India? Today, humans are facing a tremendous challenge in the form of new diseases. While we are yet to find cures for them, we are also troubled by older diseases. It has become evident that, going forward, we will need to hasten the pace of development and decrease the costs so that patients can be benefited. HPC or supercomputing is one of the technical tools that can achieve both these objectives. Every stage of the pharma process uses HPC in some way or other. While certain processes like clinical
36 EXPRESS PHARMA March 16-31, 2015
trials and regulatory related processes cannot be hurried, the discovery process can be significantly reduced. The discovery phase accounts for almost half the time in the entire process in most cases. Hence, judicious usage of HPC can help companies to cut the drug discovery process by half. Every day you spend discovering drugs adds to the cost and any reduction in time has a direct impact on the expense incurred. Many drug discovery projects have been shelved after several years of development because of side effects in animal testing. One solution offered by HPC is profiling the products and taking more probable molecules in the first place this can save tonnes of green bucks. Before the pre-clinical development, HPC can help in the identification and optimisation of new molecular entities by computational methods. By focusing on the probable molecules, the success rate of wet lab investigations increases substantially. As a result, what took weeks or even months before can now be achieved in a matter of days if not hours. Give details of ‘Pay as you use’ model for the SME pharma companies While HPC promises many benefits, there is one issueacquiring a HPC facility would require core competency that is different from the traditional expertise that a pharma organisation possesses. It will also require
There are specialised on cloud HPC services, such as Tyrone Edra that can be used by pharma companies almost as if it is their own but on a pay per use basis
investment in an infrastructure which gets obsolete quickly. There are also challenges in terms of managing the power and cooling requirements and a trained workforce is required to maintain and oversee effective utilisation. HPC on cloud based solutions eliminate a lot of management problems and shift spending from a capital to an operational model. These solutions are available on demand and with flexible pricing and are available to both enterprises and individual customers. The service can be used for few hours or even for months and is accessible anytime, anywhere .These may also be available as personalised services having an infrastructure and human interface customised to the customer’s requirement. Is this model applicable only to SMEs ? Are big size pharma companies also eligible for the same scheme? As any other technology, HPC is a great leveler. It brings large and small companies both in a level playing field. Hence both can use it and get benefited from this. Does service price chart vary depending upon the size/turnover of the company? Price structure is very simple and pricing is dependent on resource usage
and extra services one wants How many pharma companies in India have till now used your services? What is the user ratio between SMEs and big pharma companies? Our HPC on cloud service is under a year old. We have received very good response and are thinking of expanding this service. However, we do have very few pharma companies from India using this until now. We do have some bio-informatics firms who do work for their pharma using our HPC on cloud service. What percentage of your revenue comes from the pharma business? What was your turnover in India during the last financial year? Pharma presently constitutes a small percentage of our total turnover. We did about `100 crore turnover in the last financial year. What do you see as challenges in the Indian market as far as pharma business is concerned? We believe that India needs to leverage its knowledge industry to develop new drugs speedily and in research of other healthcare ailments affecting our population. Technology can help reduce the cost of drugs as well its availability, if pharma companies embrace new age technologies easily available locally in our country. sachin.jagdale@expressindia.com
PHARMA ALLY VENDOR NEWS
PTI launches game-based learning for pharma, biotech and medical device industries Game-based modules will offer new interactive approaches using both 2D and 3D interactive environments PHARMACEUTICAL Training International (PTI), supplier of online and public, event-based training courses for the pharmaceutical, biotech and medical device sectors, has launched a range of gamebased e-learning courses. PTI’s unique game-based modules offer new interactive approaches using both 2D and 3D interactive environments. Users will benefit from a more engaging, entertaining and cost-saving method of acquiring new skills through role-play in real world scenarios. To mark the launch, PTI is running a competition until
March 26, 2015 which provides access to the new platform and a chance to win a free e-learning course or a 50 per cent discount on a PTI public, eventbased training course. PTI is the first company to bring the innovative gamebased interactive approach to training in the (bio)pharma and medical device sectors, enhancing its existing range of popular e-Learning courses. Including topics in business strategy, clinical, manufacturing, medical devices and diagnostics, R&D and regulatory affairs, a range of modules have now been created to allow
Users will benefit from engaging, entertaining and costsaving method of acquiring new skills
‘players’ to learn through interactive quizzes and a 3D virtual environment. Already used successfully in other sectors, the game-based learning approach enhances traditional training methods for personnel in the (bio)pharma and medical device industries, promoting friendly competition and providing motivation for staff to become more efficient, productive and knowledgeable. Speaking about this new approach, Rosie Bernard, Managing Director, PTI, said, “At PTI, we want to bring the very best learning experience to our customers, whether they are look-
ing for distance learning, event based or tailored on-site training. Game-based learning is a new approach for our customers that will help them develop new skills in a much more engaging and entertaining way.” Competition entrants can experience and explore the 3D interactive environment while competing with colleagues around the globe by selecting their area of interest and completing an interactive quiz. Winners will be selected on March 27, 2015. EP News Bureau-Mumbai
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PHARMA LIFE I N T E R V I E W
‘Salary increases for pharma have been higher than overall industry’ Pharma has been one of the topmost industries when it comes to recruitment, and this year hasn’t been any different. Anandorup Ghose, Rewards Consulting Practice Leader at Aon Hewitt India, shares the outlook for the coming year in an interview with Shalini Gupta
How many pharma companies were surveyed out of the total? Were these MNCs or domestic companies? . A total of 50 companies from life sciences sector participated in the 2014-15 Aon Hewitt India Salary Increase Survey. The break up for the sub sectors is as follows: ◗ Pharmaceutical: 28 ◗ Medical devices: 15 ◗ Clinical Research Organization (CRO): 7 Out of these 50 surveyed companies, 15 are Indian and 35 are foreign multinationals.
while salary increase for life sciences industry has dropped over the past few years, the same has been higher when compared to the overall industry. The salary increases for the pharma industry have been higher than that of the overall industry which is a result of the higher growth that the industry has seen when compared to the overall GDP growth rate. For the period 2009-13, the GDP growth rate has been six per cent while the pharma industry has grown by 20 per cent (domestic growth at 18 per cent and exports by 26 per cent). This possibly explains why pharma has sustained the spot of being the industry with the highest salary increase. Compensation has been the major controller to attract as well as retain talent in the life sciences sector even as it continues to face talent
The salary projection for pharma has been increasing over the years (from 12 last year to 12.2 this year). What do you see as a reason for this, specifically with respect to the industry? As highlighted in Table 1,
crunch and high attrition rates (typically between 18-22 per cent). While cost optimisation is quite the buzzword, a lot of organisations were observed to focus on achieving this through increasing business efficiencies and productivity than through lower salary increases. On one hand, 2014 was a
year of several new product launches, new MNCs venturing into the country, mega-mergers and on the other hand, the industry had to deal with regulatory changes, volatile currency fluctuations, etc. Life sciences is a highly knowledge-driven sector, wherein the talent pool is limited especially in technical and niche roles (e.g positions in R&D, regulatory affairs, sales, clinical monitoring etc). Sourcing / selection for most of the functions is specific and limited to pharma/medical devices industry only. Sales and marketing, which is a major chunk of the employee population for pharma and medical devices sub sectors, require niche selling skills especially for specialty/ super specialty therapies/ large medical equipment.
Table 1
Table 2
Year
Life Sciences
Overall Industry
2012 (Actual)
12.9
10.7
2013 (Actual)
12.5
10.2
2014 (Actual)
11.9
10.4
2015 (Projected)
What could be the reason for a greater focus on performance differentiation? Kindly detail pay hikes associated with performance differentiation across management levels? As opposed to other industries how would this be reflected in life sciences? A significant proportion of firms today are linking performance to rewards. Performance rating linked payout is almost becoming a norm. Companies have become increasingly stringent in doling out top ratings to its employees. Employee distribution has become significantly sharper since 2007. Interestingly for life sciences, the salary increase premium received by ‘Top Raters’ is 1.7x times the average performers. The pharma industry has been
12
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10.6
Life Sciences
Overall Industry
Levels of Performance
2012
2013
2014
2012
2013
2014
Far exceeded expectations
18.5
18.7
18.9
16.2
15.3
15.4
Often exceeded expectations
15.6
15.6
15.3
12.9
12.1
12.7
Met expectations
11.1
11.1
11.3
9.5
9.1
9.4
Often did not meet expectations
5
4.8
5.2
4.1
3.7
3.6
Did not meet expectations
0.7
0.5
0.7
0.4
0.6
0.9
EXPRESS PHARMA
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March 16-31, 2015
PHARMA LIFE more performance focused than other industries. Performance differentiation can be done through differentiated salary increases, relevant normal curves and pay mix. On performance differentiation through salary increases, while the overall industry has looked at an index (Far exceeds vs. Met expectations rating) of 1.7 across the last three years, it’s the pharma industry that has pushed the index from 1.6 to 1.76 in the last three years. The industry is increasing its performance focus to ensure that performance is recognised and rewarded. Table 2 shows the salary increase percentage by levels of performance for life sciences and overall industry: What would be the hikes for lateral entrants and entry level employees? What factors would influence this? Also, how would this be different for MNCs and domestic companies? For the entry level employees, the salary hike would be the same as the staff cadre and other lower
With a plethora of job opportunities available in the industry, new MNCs venturing into the country, it gets harder to retain the key talent
levels of management. For 2014 actuals and 2015 projections, at an overall employee level basis, we have not observed much difference between salary increases provided by Indian and foreign multinationals. Table 3 highlights the average salary increase percentage for life sciences sector across various levels of management:
Talent attrition has witnessed a 31 per cent jump with it being 5.9 per cent in 2014 and 4.5 per cent in 2013. Why? With a plethora of job opportunities available in the industry, new MNCs venturing into the country, mega-mergers, etc; it gets harder to retain the key talent. Key talent (which is a small percentage of total employees) is always the one that gets targeted first. Attrition is bound to be seen in this category. Talent crunch has been an ongoing issue in the industry for the past many years now. Even though life sciences has been the front runner when it comes to providing salary increases, the real time challenge of attrition still persists. Attrition happens the most at the junior most level and decreases as the level of management increases (attrition is the least for top/senior management). Table 4 highlights the average salary increase and attrition percentages for life sciences sector across various levels of management: shalini.g@expressindia.com
Table 3 Employee Groups
2014 (Actual)
2015 (Projected)
All employees
11.9
12
Top executive/ senior management
11
11.1
Middle management
11.5
11.7
Junior manager/supervisor/professional
12
12.1
Clerical/admin/tech
11.8
11.9
Manual workforce
10.8
11.1
Table 4 Levels of management
Attrition - 2014
Salary Increase - 2014 (Actual)
Salary Increase - 2015 (Projection)
Top executive/ senior management
6.9
11
11.1
Middle management
13.2
11.5
11.7
Junior Manager/supervisor/ professional
18.6
12
12.1
Entry level
22.2
11.8
11.9
64 EXPRESS PHARMA March 16-31, 2015
NEWS
Kiran Mazumdar-Shaw honoured by Federation UniversityAustralia Appointed as an ambassador of the university for a three-year term KIRAN MAZUMDAR-SHAW, Chairperson and Managing Director, Biocon has been honoured by Federation University Australia (FedUni) by dedicating a road at the University’s Mt Helen Campus to her as ‘Mazumdar Drive’. She has also been appointed as an Ambassador of the University for a three-year term. “The University is so honoured to welcome Kiran Mazumdar-Shaw back to the university she studied at all those years ago,” said Professor David Battersby, Vice-Chancellor, Federation University Australia. Mazumdar-Shaw is the first Indian to be named Ambassador by the University. The University appoints eminent people from different walks of life, including business leaders, as Ambassador to contribute to the institution’s development. “Mazumdar-Shaw was able to use the skills she learned here studying brewing to develop Biocon into one of the world’s leading biopharmaceutical companies. We are also delighted that she has agreed to become an Ambassador for FedUni. This role will entail the promotion of the university on specific occasions,” Professor Battersby said. “The success of MazumdarShaw throughout her profes-
sional life is testimony to the vast opportunities that are available to FedUni students,” Dr Paul Hemming, Chancellor, said. Speaking on the occasion, Kiran Mazumdar-Shaw, CMD, Biocon, said, “I am very grateful to Federation University Australia for its generosity in naming ‘Mazumdar Drive’ in my honour. I have many happy memories of my time here and acknowledge the significant role the University played in my education and development.” Mazumdar-Shaw graduated from the Ballarat College of Advanced Education (one of FedUni’s predecessor institutions) in 1975 as a Master Brewer in Malting and Brewing. She also received an honorary Doctorate of Science from the University in 2004 in recognition of her preeminent contribution to the field of biotechnology. Mazumdar-Shaw has been on a week-long visit to Australia during which she has had a series of meetings with the members of the Australia-India Business Council. She also delivered the 17th Dr KR Narayanan Oration on ‘Australia & India: Combining Technology and Entrepreneurship to Innovate the Future’ , at the Australian National University, in Canberra. EP News Bureau-Mumbai
REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.