Express Pharma June 1-15, 2014 by Indian Express

VOL. 9 NO. 15 PAGES 74

www.expresspharmaonline.com

Cover Story Environment Day Special Management M&A frenzy in pharma: Here to stay? Pharma Life ClinTec International bags award for biz innovation 1-15 JUNE 2014,` 40

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CONTENTS MARKET

M&AFRENZYIN PHARMA: HERE TO STAY?

Vol.9 No.15 JUNE 1-15, 2014 Chairman of the Board Viveck Goenka

IFC LENDS $147.5 MILLION TO JUBILANT PHARMA

VENUS REMEDIES BAGS ADDITIONAL PATENT FOR VANCOPLUS FROM US

ARVIND REMEDIES SIGNS MoU WITH SRM UNIVERSITY

PHARMA SECTOR TO GET PRIORITY ATTENTION OF NEW GOVT, SAY REGULATORS AT iPHEX 2014

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua 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

Mergers and Acquisitions (M&As) within the Indian pharmaceutical industry is not a new phenomenon. However, the deal between Sun Pharma and Ranbaxy is different in a way that it has certainly paved the way for more such M&As in the future | P30 P41: VENDOR NEWS Mankind Pharma to adopt SoftLayer’s cloud platform

MANAGEMENT

P64: INSIGHT A study on field force attrition and the response of consulting doctors in Greater Mumbai

P66: AWARD Kiran Mazumdar Shaw receives coveted ‘Othmer Gold Medal 2014’

Scheduling & Coordination Rohan Thakkar

P67: CAMPUS BEAT

CIRCULATION Circulation Team Mohan Varadkar

Lupin, Smt Kishoritai Bhoyar College of Pharmacy in tie up

PHARMA LIFE

OUTSOURCING NOW AND INTO THE FUTURE — AN ANIMAL HEALTH STORY

PHARMA ALLY

‘THE NEED OF THE HOUR IS TO CHANGE THE MIND-SET OF PROFESSIONALS’

‘I FORESEE HUGE GROWTH IN BIOPROCESS SECTOR’

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

No easy wins in pharma

s we go to press, the PfizerAstraZeneca deal is called off for now but that story is far from over. Both parties have retreated to their corners of the boxing ring so its time to mull over the learnings from this latest episode of M&As in the pharma world. Why did the British drug maker rebuff Pfizer's overtures? National pride combined with a dogged determination of its own worth, or rather the strength of its pipeline. Groups within UK and Sweden also raised objections over concerns that the merger was motivated purely by tax benefits. Even though the Pfizer chief executive officer Ian Read promised that UK would be the base for at least a fifth of its global R&D team for a minimum of five years, there was no doubt that some drug development programmes would be wound up and production facilities shut down as the merger was all about increasing efficiencies. Read's statement said his company “will continue our focus on the execution of our plans, bringing forth new treatments to meet patients’ needs and remaining responsible stewards of our shareholders’ capital.” Pfizer's strategic review of its operations has seen the division of its operations into three main areas and a recent Datamonitor report analysed how the merger with AstraZeneca would shore up all three divisions. His statement implies that the US company will continue with its break-up plans. AstraZeneca too has refocused on certain pivotal therapy areas as key products go off patent. With its shares taking a beating after its US suitor walked off, the AngloSwedish company will be under even more pressure to vindicate its stance. The Pfizer chief claimed that the proposed merger got the thumbs up from shareholders of AstraZeneca and blamed UK's takeover code and drug pricing norms for what he called a "lost opportunity". One sentence stood out in recent media reports. Read has been quoted as saying, “It is inconsistent to me [for the] Government to wish to have a vibrant science centre and vibrant investment in clinical research, and yet not to have big market incentives.” Does that sound familiar? It’s the same argument (the tone if not the actual words) that MNC pharma has used to criticise the Indian

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June 1-15, 2014

US FDAimport bans eroded the Ranbaxy brand enough for Daichii-Sankyo deciding to cut its losses but with Sun Pharma itself facing the same kind of fire,will the ‘Turnover Tsar’ succeed in scripting another win?

government's stand on IPR! And it is ironic that Sun Pharma faced opposition to its plans to take over Ranbaxy from the very stakeholders that were cheering on its MNC counterpart in the UK. India's market regulator SEBI is investigating charges of investor trading by Sun Pharma subsidiaries while two investors filed a complaint on the same issue in the Andhra Pradesh High Court. The HC has since disposed of this case and the merger is free to proceed to the next stage, but the company will still have to deal with SEBI's investigation. Both deals faced a backlash as the companies were not perceived to be as transparent as possible with all stakeholder groups, ranging from regulators to shareholders. Managements mulling such mergers will have to be careful to explain how such deals will not just make more profits and improve the bottomline but also meet patients' needs. Their explanation of better efficiencies leading to more chances of getting better productivity out of research programmes will have to convince all stakeholders, not just shareholders that such deals are in everybody's interest. The Sun Pharma-Ranbaxy merger is also seeing sceptics point out that the former may have just bitten off more than it can chew. US FDA import bans eroded the Ranbaxy brand enough for Daichii-Sankyo deciding to cut its losses but with Sun Pharma itself facing the same kind of fire, will the ‘Turnover Tsar’ succeed in scripting another win? Express Pharma analyses the impact of such mergers on the pharma sector in India, with a special focus on service providers. (M&A frenzy in pharma: Here to stay?, page 30). The cover story this issue is timed with World Environment Day (A step towards renewable resources, page 22). The section is our effort to highlight the need to turn 'green' by harnessing renewable energy sources like solar power. Just a handful of savvy players seem to have seen the writing on the wall but we sincerely hope that their tribe increases. This is one bandwagon that is seems to be worth jumping on.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Merck proposes creation of global alliance for elimination of schistosomiasis Calls on different NTD constituencies to join and support WHO’s ambitious goal of schistosomiasis elimination MERCK PROPOSED the creation of a global alliance to help the World Health Organization (WHO) achieve its goal of eliminating schistosomiasis worldwide in Geneva. Merck will be a founding member of this new global alliance aiming to further support WHO’s goal of eliminating schistosomiasis. Merck calls for different NTD (neglected tropical diseases) constituencies to join on focusing efforts to address remaining gaps and challenges to meet the elimination target. Stefan Oschmann, Member of the Executive Board of Merck and Chief Executive Officer Pharma, presented this initiative on the occasion of the 67th World Health Assembly, the decision-making body of WHO, in the presence of HE Hanny-Sherry Ayittey, Minister of Health of Ghana, and Dr

Merck will be a founding member of this new global alliance aiming to further support WHO’s goal of eliminating schistosomiasis. Merck calls for different NTD constituencies to join on focusing efforts to address remaining gaps and challenges to meet the elimination target Hiroki Nakatani, Assistant Director-General Neglected Tropical Diseases of WHO. Merck is committed to helping WHO to eliminate the worm disease schistosomiasis in Africa. As an important part of its responsible entrepreneurship, the company launched the Merck Praziquantel Donation Programme

in 2007. Praziquantel is well tolerated and the most effective treatment to date for schistosomiasis. Since then, more than 38 million children have been treated and over 160 million tablets have been donated. While other neglected tropical diseases have demonstrated the value of inclusive alliances, as of today no alliance for schis-

tosomiasis yet exists. “We see this initiative as a major development,” said Oschmann. “This alliance will allow the different constituencies to engage in a coordinated approach to best address the challenges on how to meet the elimination target.” Merck will work with WHO and partners to define the appropriate structure of this alliance to

ensure its pragmatic operational functionality. “We need to keep up the momentum in translating our commitments into actions, with Merck’s commitment to raise our donation up to 250 million tablets by 2016. We also need to ensure that our donation benefits the maximum number of children. The global alliance is a new opportunity to bring together all interested partners and create a new turning point for the elimination of schistosomiasis,” said Oschmann. “Providing the drug praziquantel is only one part of the solution; we therefore recognise the need to go beyond this and foster a holistic, integrated approach to supporting WHO in reaching the ultimate elimination target.” EP News Bureau – Mumbai

IFC lends $147.5 million to Jubilant Pharma To expand access to affordable pharmaceuticals IFC, A member of the World Bank Group, is lending $147.5 million to Jubilant Pharma to enable better access to quality and affordable pharmaceuticals in underserved markets in India and across the world. Jubilant Pharma, a whollyowned subsidiary of Jubilant Life Sciences, is incorporated in Singapore, with manufacturing operations in India, the US and Canada.

Of the total financing package, $110 million is from IFC’s own account. The remaining $37.5 million is from IFC’s Managed Co-Lending Portfolio Program, which provides additional long-term financing through co-financing partners. The loan will help Jubilant Life Sciences increase focus on the pharma sector and strengthen its generic drug

manufacturing facilities in India. “We consider IFC a longterm partner with significant healthcare expertise across emerging markets. IFC’s contribution goes beyond financing. IFC will also help us strengthen our quality assurance and risk mitigation mechanisms and make the company systems more robust,” said Shyam S Bhartia,

Chairman and Managing Director, Jubilant Life Sciences. “IFC’s long-term financing package will consolidate our entire pharmaceuticals business under Jubilant Pharma and build global competitiveness.” “Health is a priority sector for IFC in India. There is an urgent need to expand access to affordable and quality healthcare, especially among

low-income communities,” said Vipul Prakash, Director – Manufacturing, Agribusiness and Services, Asia Pacific, IFC. “This investment will contribute to wards making the Indian pharma sector globally competitive, and improve access to affordable medicines to a wider population.” EP News Bureau – Mumbai

EXPRESS PHARMA

June 1-15, 2014

MARKET

Venus Remedies bags additional patent for Vancoplus from US The formulation will be commercialised in the US market through technology transfer/outlicensing of exclusive marketing rights route VENUS REMEDIES has bagged additional patent for Vancoplus from US PTO. Vancoplus is an antibiotic adjuvant entity effective in one the most deadly resistance by Methicillin Resistant Staphylococcus Aureus (MRSA). Developed by the Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies, Vancoplus is the only solution till date for MRSA with more than nine per cent of success rate. Dr Manu Chaudhary, Joint managing Director, Venus Remedies said, “The patent is valid till 2032. We have already initiated the process for

pre IND meeting with US FDA and we are quite optimistic to get a fast track approval for this product because MRSA is under the list of limited pathogens identified under GAIN act by FDA and Vancoplus falls in that QIDP category.” Venus Remedies already have product patent for Vancoplus from US PTO, this additional patent with broader coverage for use and method of treatment will be beneficial for the company. The formulation will be commercialised in the US market through technology transfer/outlicensing of exclusive marketing rights

It took Venus Medicine Research Centre (VMRC) more than seven years to develop this product, which has received an overwhelming response from the medical fraternity in India since it was launched in the country four years ago route and we are open for such deals. It took Venus Medicine Re-

search Centre (VMRC) more than seven years to develop this product, which has re-

ceived an overwhelming response from the medical fraternity in India since it was launched in the country four years ago and is growing with more than 25 per cent CAGR in Indian market. “In view of the steep rise in the prevalence of MRSA, VRSA and hGISA infections, Vancoplus will be the need of the hour, due to its high potency against these infections and mixed bacterial infection of gram negative and gram positive pathogens. We have developed Vancoplus to address this unmet need,” said Chaudhary. EP News Bureau-Mumbai

MARKET

Arvind Remedies signs MoU with SRM University To launch new drugs for diabetes and coronary heart disease ARVIND REMEDIES has entered in a Memorandum of Understanding (MoU) with SRM University, Kattankulathur, Tamil Nadu to transfer the patent right to undertake exclusive manufacturing, marketing and commercialisation of drugs for type II diabetes and coronary heart disease. These drugs will be manufactured in the form of tablets and will be launched in mid 2015, first in the domestic market which will be followed by the global market. The MoU was signed in the presence of Dr TR Pachamuthu, Chancellor, SRM University. Registrar of SRM University Dr N Sethuraman, signed the MoU on behalf of SRM University, while Dr B Arvind Shah, Managing Direc-

These drugs will be manufactured in the form of tablets and will be launched in mid 2015, first in the domestic market which will be followed by the global market tor and Chief Executive Officer signed the MoU on behalf of Arvind Remedies, Chennai. Other delegates who were present in the signing ceremony include, Dr GP Dubey, Inventor of these drugs & Study Director, ISISM, SRM University, Prof TP Ganesan, Pro Vice chancellor, SRM University, Dr K Ilango, Dean, ISISM, SRM

University, Dr Aruna Agrawal, Professor, Faculty of BHU and Anand Shah, Vice President, Arvind Remedies. Dr B Arvind Shah, Managing Director and Chief Executive Officer, Arvind Remedies, said, “According to the International Diabetes Federation, 382 million people across world have diabetes, which is ex-

pected to rise to 592 million by 2035. The number of people with type II diabetes is increasing in every country. In order to curb this disease, we have come up with new drug that is from the botanical source which ensures zero side effects on the health of the patient. We are expecting this new drug to be available in the markets by mid 2015.” Shah said, “Coronary heart disease is also the most common type of heart disease and is killing more than 385,000 people annually. We are happy to share that, we have been successful in developing a new drug, which will help in treatment of coronary heart disease.” EP News Bureau-Mumbai

Cancer Genetics acquires BioServe India The acquisition positions CGI to immediately participate in the high growth Indian molecular diagnostics and oncology services market CANCER GENETICS, a DNA-based diagnostics company focused on developing genomic-based oncology tests and services, announced the agreement to acquire BioServe Biotechnologies (India) for approximately $1.9 million, primarily in CGIX stock and other deferred consideration. The transaction is expected to close during the third quarter of 2014 and is subject to customary closing conditions and government approvals in India. Under the terms of the agreement, BioServe Biotechnologies (India) (BioServe India), headquartered in Hyderabad, will become a subsidiary of CGI, and will be renamed

EXPRESS PHARMA

June 1-15, 2014

Cancer Genetics India. CGI plans on retaining all 33 current employees of BioServe India, and further expanding and strengthening the sales and clinical teams in India. BioServe India currently operates out of a state-of-the-art 14,000-square-foot genomics facility in Hyderabad. BioServe India is backed by Ventureast, a pioneering venture capital institution based in India, which has enabled over 80 seed, early and growth stage businesses in a broad array of sectors including technology, life sciences and clean environment. By utilising BioServe India's molecular services, researchers can identify genetic

markers, validate drug targets and correlate clinical and molecular data to accelerate the development of new and effective drugs. Additionally, BioServe India’s growing clinical diagnostics capabilities in oncology and next-generation sequencing are well-positioned to serve the needs of improving oncology diagnostics care and management throughout India. “With Bioserve, CGI will become better positioned to increase our global presence in personalised cancer care and further improve outcomes and lower costs for cancer patients,” said Panna Sharma, Chief Executive Officer, Cancer Genetics. “The BioServe

India team adds immediate positive impact, high-quality revenue, and provides a clear path to an accretive deal for shareholders. The infrastructure and enhanced capacities in next generation sequencing for oncology accelerate our development plans while positioning us to make more effective use of our capital.” “It’s a proud moment for us at BioServe as we join forces with one of the leading cancer diagnostics providers. There are great synergies which we expect to unlock by combining our visions and teams together,” said Rama Modali, Founder, BioServe India. EP News Bureau – Mumbai

US FDA raises concerns over Wockhardt’s US unit THE US Food and Drug Administration (US FDA) has expressed concerns over production processes at the US unit of Wockhardt, a top executive said, possibly adding to a spate of regulatory troubles facing the Indian generic drugmaker. The US is Wockhardt’s biggest market and the US FDA has already banned the import of generic drugs from its two plants in India, citing quality lapses in the manufacturing process. Murtaza Khorakiwala, Managing Director, Wockhardt said on Tuesday Wockhardt had responded to the FDA's observations but declined to give details. If the FDA is not satisfied with the response, it could ban production from its Chicago-based Morton Grove Pharmaceuticals unit, which accounts for more than 50 per cent of Wockhardt’s sales in the US, a region that contributed 45 per cent to its sales in the fiscal year ended March. The FDA had sent Wockhardt a ‘Form 483,’ a letter in which the agency typically outlines concerns discovered during inspections. Worries about quality control in India's $15 billion drug industry surfaced in the past year after plants run by Ranbaxy Laboratories and Wockhardt were barred from sending drugs to the US after falling short of the FDA's ‘good manufacturing practices’. That has hurt India's reputation as a supplier of safe, affordable drugs. Indian drug exports grew by just 2.6 per cent in the 2013/14 fiscal year ended in March. Two years ago, the growth rate was 23 per cent. Reuters

MARKET POST EVENT

Excel Life Sciences organises event on International Clinical Trials Day Key topics discussed included audio visual recording of informed consent and reimbursement EXCEL LIFE Sciences, a USbased, India-focused trial management organisation, recently hosted an event at Indian Habitat Centre to commemorate International Clinical Trials Day. The aim was to help spread awareness and create a platform for researchers to exchange experience and ideas for better development of clinical research. The event was attended by doctors and researchers where key topics discussed included audio visual recording of informed consent, reimbursement and compensation for

clinical trial-related injuries and recent regulatory changes. The panelists tried to answer questions around the following topics: Should audio visual recording of informed consent mean that a sub set of

patients are denied the opportunity to participate in research just because they do not agree to be filmed? How should this be addressed given that the guidelines clearly state that patients not comfortable with

audio visual recording of informed consent should not be permitted to participate in a clinical trial? What are the options available for patients and researchers? The need for explicit guidelines regarding reimbursements to be paid to patients in a clinical trial and on compensation for trial-related injuries was also discussed. Improper implementation coupled with pressure to recruit patients within definite time frames in a clinical trial, leads to compensation being used as a bait to lure potential subjects. The

participants shared their experiences during the last one year with the new regulations some of which go against the basic principles of research and have been made in haste with far reaching impact on clinical research in India. It was felt that there is a need to create greater public awareness about research and how it benefits the society. Some suggested strategies included using the outreach of social media to provide information and promote clinical research events. EP News Bureau-Mumbai

MARKET POST EVENT

Pharma sector to get priority attention of new govt,say regulators at iPHEX2014 Focus on building Brand India Pharma, through regulatory reform and raising standards to global norms Usha Sharma Mumbai SENIOR OFFICIALS of the Ministry of Commerce, as well as head of Central Drugs Standard Control Organization (CDSCO) said that the regulatory reforms in the pharma sector would get priority attention as soon as the new government starts functioning. This includes deliberation on the recommended amendments to the Drug & Cosmetics Act as well as strengthening the regulatory mechanisms at both centre and state levels. They were speaking on the sidelines of the three-day iPHEX 2014 event, organised by Pharmexcil, and supported by the Ministry of Commerce, Govt of India. Inaugurating the event, Gopal Shetty, Member of Parliament, gave his best wishes to the show and hoped that the different stakeholders would use the time to discuss and work out their differences. Speaking for the new Narendra Modi-led government, he assured the the in-

EXPRESS PHARMA

June 1-15, 2014

dustry that they would get all the support they asked for, both at the state and the Centre. The event was co-located with Pharma PRO & PACK, organised by the Indian Pharmaceutical Machineries Manufacturers’ Association (IPMMA). The show saw participation from 40 drug regulators from 20 countries as well as delegates from approximately 150 countries and 5000 pre registered participants. Divulging more details of the regulatory reforms on the anvil, Dr GN Singh, Drugs Controller General (India), said, “Rs 3000 crores has been set aside in the 12th Five Year Plan, to improve the infrastructure, hiring more staff and capacity building of the drug regulatory mechanism over the next three years. We will be setting up a National Dug Regulator Training Academy in Hyderabad. In addition, to train new staff, every drug controller will have to undergo training twice a year.” The emphasis on training is aimed at changing the mindset

and attitude of regulators. In this context, Dr S Eshwara Reddy, Deputy Drug Controller of India, CDSCO also mentioned that the designation would change from ‘Drug Control Inspector’ to ‘Drug Control Officer’. On the issue of hiring more staff, the Drug Controller General (India) (DCGI) said that in the next three years, there are plans to ramp up staff strength from 1500 to 3000 at both the Centre and state levels. Dr Singh also revealed that e-governance would become mandatory for all states, so that the process of getting manufacturing licenses and approvals would be streamlined and transparent. “We are concerned with the safety, efficacy and quality of products. We are strengthening the regulatory system as part of the global harmonisation process and will be raising the standards. Within two-three years, we will see a sea change. We will have a robust regulatory standard which will be seen

MARKET and envied by other countries. We are confident that our pharmacopoeia and monographs will be at par with others.” At present, around 50000 samples are tested at the state level annually; the aim is to increase this to two lakh. 10 new drug testing laboratories will be added to CDSCO’s current testing capabilities, with each state having its own lab. Similarly, 10000 samples are currently tested per year at the centre and this will be ramped up to 90000. Currently, three to five per cent samples are Not of Standard Quality (NSQ) and the aim is to reduce this to three per cent. As part of the process of raising standards and the global harmonisation process, the CDSCO and US FDA have already jointly organised four workshops for the industry. Eight more workshops are scheduled to be held before October this year, encompassing two more topics. Wishing the event all the success possible, Sudhanshu Pandey, Joint Secretary, Department of Commerce, Ministry

of Commerce & Industry, Govt of India, said, “We will work together with different countries embassies, regulators, industrialists for the improvement of the Indian pharmaceutical industry. An event like iPHEX 2014 will give us better results. We will ensure that this event moves to the next level each year. This is not just a business meeting for buying and selling. iPHEX was started to convey a much broader message and is part of a larger cause. We have taken the first step last year when we launched iPHEX. This year the second successful event is another small step and I am sure we will continue to take much larger steps in the future.” Dr PV Appaji, Director General, Pharmexcil revealed that IPEX 2015 was scheduled to take place from May 13-15. In addition, the first global edition of iPHEX will be held in Nigeria, Africa this year. u.sharma@expressindia.com

◗ EXHIBITORS FEEDBACK Even though the iPHEX show is only in its second edition,exhibitors and visitors had high expectations and this is reflected in the comments.Most support the show but hope for higher return on investment. BR Sikri,Director,ABS Mercantiles shares,“This year’s show has witnessed less number of participants compared to previous years.This can not be compared with other events like CPhI because over there people come to meet and exchange their thoughts. Whereas iPHEX is a platform for genuine buyers and sellers to come and meet and exchange their notes and do their real time business and I personally feel this is an attractive aspect of this event,which attracts buyers and sellers to discuss about their business and opens better avenue to do large number of business worldwide. NM Mehta,Managing Director,Newtronic Lifecare Equipment felt that the exhibition is a very good show but the timing (May) is not ideal since it is a vacation month in Mumbai. He puts down the lesser than expected footfall to this reason and hence suggests that April could be the ideal month for this show in the future. Other exhibitors like Sandip Mhatre, Group Managing Director,Thermolab Group say that while the exhibition met their expectations,in future they expect good number of decision makers to participate especially from the foreign markets.“This year we have registered less number of foreign delegates at our stall and limited number of business inquiries.This time we noticed that there were less number of Indian visitors which I anticipate will increase in the coming years.There are many exhibitions taking place in a year and I feel that it should

be once in two years so we (exhibitors) can show something new and developed products to our clients and visitors,” he said. Others like SP Dharma,General Manager – Sales and Marketing (Packaging Machinery – Pharma and Food) Labindia Equipments say they received good footfalls during the second day of the event.They realised that delegates from Africa were less interactive and he suggests that Pharmexcil should give them dedicated time to meet exhibitors at their individual stalls. K Bhaskaran,Managing Director,Suntech TEKNOPA too felt that day two of the event showed better outcome in terms of business inquiries and visitors.In his opinion,now-adays exhibitions have become the best platform to meet customers as well as prospective customers and moving forward they will use this platform.He felt that the organisers have done good ground work for this year’s show but he too suggested that this event should be held next year in April. Another explanation for the less-thanexpected crowds at the show came from Karnik Parikh,Director,Pharmalab who noted, “Due to unavoidable circumstances of Lok Sabha elections,this year the event is ok.But I suggest that the organisers shift this event from May to little ahead ideally October -March in 2015.As this is a vacation period,most decision makers are out of town.For us,day two of the show was better and the busiest day throughout the three day show.Going forward I feel this is a new show and we have to support it to help this event grow better.” With a little more fine tuning,iPHEX 2015 is sure to be better and bigger than this year, building on the immense good will in the industry.

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June 1-15, 2014

MARKET GROWTH TRACKER

IPM clocks ` 6597 crores in April 2014 Nine therapies have outgrown the IPM growth and five therapies have double digit growths THE INDIAN pharmaceutical market (IPM) clocked ` 6597 crores in April 2014 and has seen a growth of 5.2 per cent. Amongst the top 10 companies, Mankind grew at 11.3 per cent followed by Lupin at 9.5 per cent and Sun Pharma at 8.6 per cent. 31 corporates have crossed the growth of IPM amongst top 50. Amongst the top 50 corporates, Akumentis has the highest growth of 46.6 per cent followed by Ajanta at 39 per cent and Biocon at 35.3 per cent. Amongst the 11-20 ranked companies, Macleods has shown high growth at 25.6 per cent followed by Aristo at 18.7 per cent and Torrent at 14.5 per cent. Amongst the 5075 ranked corporates, Corona shows high growth at 34.9 per cent followed by Apex at 33 per cent and Pharmed at 28.2 per cent. Amongst the 76-100 ranked corporates, Gland Pharma has grown the fastest at 46.6 per cent. Indian companies have grown at 7.9 per cent versus -1.6 per cent for MNCs in April 2014. Amongst the top 50 in MNCs MSD grew the highest at 13.5 per cent, followed by Merck at 9.1 per cent and AstraZeneca at 5.5 per cent. Under the NonNLEM category, Indian companies are growing at 10.4 per cent whereas MNCs at 1.6 per cent. The DPCO 2013 containing molecules market was at –11.5 per cent whereas the nonDPCO market grew by eight per cent resulting in an overall growth of 5.2 per cent for April 2014. The DPCO 2013 portfolio for Pfizer de-grew at 26.9 per cent, GSK de-grew at 19.5 per cent and Ranbaxy degrew by 25 per cent. From therapy perspective, nine therapies have outgrown the IPM growth and five therapies have double digit growths. The respiratory

20 EXPRESS PHARMA June 1-15, 2014

Withbonus units at full value Val in Crs

Rank

CORPORATE

MAT

(Val in Crs)

MAT Apr -14

MTH

IPM

Apr-14

Val (Cr)

MS%

GR% Val (Cr)

76055

100.00

5.9

MS%

GR%

6597

100.00

5.2

Abbott + Abbott HC + Novo

4880

6.42

4.2

414

6.28

0.0

Sun Pharma

4117

5.41

15.9

360

5.46

8.6

Cipla

3789

4.98

6.5

342

5.18

7.9

Zydus + Biochem

3359

4.42

7.8

291

4.41

6.0

Ranbaxy

2861

3.76

-1.8

229

3.47

-6.7

Glaxo

2730

3.59

-15.4

225

3.40

-11.2

Mankind

2699

3.55

5.0

245

3.71

11.3

Alkem + Cachet + Indchemie

2660

3.50

10.5

224

3.39

6.2

Lupin

2555

3.36

11.7

226

3.42

9.5

Pfizer

2218

2.92

3.0

197

2.98

4.2

Emcure + Zuventus

2142

2.82

14.7

183

2.77

11.6

Macleods

2018

2.65

10.3

190

2.89

25.6

Sanofi

1922

2.53

-0.1

159

2.41

-6.1

Intas

1896

2.49

7.7

167

2.54

3.6

Aristo

1851

2.43

13.4

162

2.46

18.7

Glenmark

1651

2.17

15.7

141

2.14

10.3

market grew at 13.6 per cent, gastrointestinal market grew at 4.3 per cent whereas antiinfectives grew at 0.4 per cent. The anti-diabetic market grows at 14.1 per cent and cardiac at 4.8 per cent in chronic business. The derma market grew by 11.1 per cent. From a regional perspective 13 regions have outgrown the IPM growth. The Vidarbha market grew the highest at 15.1 per cent followed by MP Market at 12.5 per cent. Three regions had negative growths in April 2014. Amongst the top brands in the IPM, Glycomet GP (34.5 per cent), Galvus Met (28.8 per cent), Skinlite (22.9 per cent), Telma (22.4), Liv-52 (15.9 per cent) amongst top 25 Brands grew amongst the fastest over April-13. A total of 123 brands launched in April 2014. Getlite, Straieout, Picnovit are the top NIs for the month of April 2014.

About PharmaTrac Val in Crs

MAT Apr 14

Super Group

VAL IN CRS

MNTH APR 14

GR%

VAL IN CRS

GR%

IPM

76055

5.9

6597

5.2

ANTI-INFECTIVES

12579

0.3

1006

0.4

CARDIAC

9451

7.9

842

4.8

GASTRO INTESTINAL

8530

5.4

774

4.3

VITAMINS / MINERALS / NUTRIENTS

6803

5.1

602

4.0 13.6

RESPIRATORY

5972

9.7

492

PAIN / ANALGESICS

5466

3.8

473

3.2

ANTI DIABETIC

5429

15.3

504

14.1 0.8

NEURO / CNS

4751

6.4

413

GYNAECOLOGICAL

4716

1.4

421

3.9

DERMA

4339

11.6

379

11.1

OPHTHAL / OTOLOGICALS

1359

8.0

128

7.9

HORMONES

1295

4.3

115

6.9

VACCINES

1104

-2.6

-13.1

ANTI-NEOPLASTICS

1054

29.1

26.9

BLOOD RELATED

927

3.8

3.9

OTHERS

886

3.9

5.9

ANTI MALARIALS

624

1.6

11.4

SEX STIMULANTS / REJUVENATORS

430

4.6

0.2

STOMATOLOGICALS

341

8.1

8.3

PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage. For more information, visit http://www.aiocd.net

EVENT BRIEF JULY 2014 11

Contract Manufacturing 2014

CONTRACT MANUFACTURING 2014 Date: July 11, 2014 Venue: Hotel Hilton, Sahar, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Contract Manufacturing Subcommittee will organise the first conference on Contract Manufacturing 2014. The main theme of this conference is ‘360 degrees of Contract Manufacturing.’ Eminent experts in contract manufacturing, research, and regulatory spheres from the Indian pharmaceutical industry will converge and interact on various recent developments. Contact details Indian Drug Manufacturers’ Association 102 - B, ‘A’ Wing, Poonam Chambers Dr Annie Besant Road, Worli, Mumbai – 400018 Tel: +91-22-24944624/24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Website: www.idma-assn.org

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: Amrita Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference which aims to make a ‘industry-scientists-academics’ collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/ researchers/ students and professionals from academia and industries from all over the country and abroad. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Emerging Trends in Drug Discovery: AICADD – 2014

Contact details Dr PK Krishnan Namboori Asso. Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug Discovery- AICADD-2014 Computational Chemistry Group (CCG) Computational Engineering and Networking AMRITA Vishwa VidyapeethamAmrita University Amritanagar, Coimbatore - 641 112 Tel: (0422) 2685000 (Extn: 5592) Email: aicadd_2014@cb.amrita.edu / aicadd2014@gmail.com Website: http://www.amritaccg.inConference URL: http://www.amritaccg.in /aicadd2014

PHARMALYTICA 2014 Date: September 25-27, 2014 Venue: BIEC, Bangalore Summary: UBM India will host PharmaLytica 2014 in Bangalore from September 25-27, 2014. PharmaLytica 2014 will be a combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods. It is a platform connecting the pharmaceutical community with outsourcing solution providers, including clinical trials, contract research, custom manufacturing, biotech, IT and analytical services. PharmaLytica 2014 will spread over 2,000 sq mt featuring over 100 plus exhibitors. The event will be supported by Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA). Also, India Pharmaceutical Association (IPA), Confederation of Indian Pharmaceutical Industry (CiPi) and Association of Contract Research Organisation (ACRO) will support the event. Contact details Rahul Deshpande Sr Manager - Projects E: rahul.deshpande@ubm.com T: +91 22 61727165 | M: +91 98209 02476

EXPRESS PHARMA

June 1-15, 2014

cover ) Indian pharmaceutical industry requires uninterrupted power supply and in the face of severe scarcity of conventional resources, companies need to find sources of renewable energy to meet their power requirements

ASTEPTOWARDS

BY USHA SHARMA

RENEWABLE RESOURCES T

he Indian pharmaceutical industry is ranked third in the world in terms of production volume and 14th in terms of domestic consumption value. India has the highest US FDA approved manufacturing plants outside the US. As per data available in the public domain in 2013, there were

22 EXPRESS PHARMA June 1-15, 2014

4,655 pharma manufacturing plants across India, employing over 3,45,000 people. With the growing scarcity of existing natural resources in India and high alerts of global warming, the day when the industry will become handicapped due to unavailability of natural resources, is not too far.

Extensive energy consumption The pharma industry produces multiple products in the form of tablets, capsules, oint-

ments, liquids and powder. The sector requires uninterrupted energy flow in the manufacturing units. Manufacturing processes are energy intensive and the requirement of thermal and electrical energy varies depending on the product. Venkat Jasti, Chairman and Chief Executive Officer, Suven Life Sciences also talks on the significance of uninterrupted power supply in pharma manufacturing sites. He says, “The pharma manufacturing industry requires

continuous process and optimisation is done only through installation of some mechanical devices which can measure and optimise certain equipment.” It has been reported that approximately 20 per cent of the total energy consumption of the units within the sector is due to head load. To overcome the challenges, the pharma industry is taking necessary steps towards renewable energy (green energy). Madhu Rao, Senior Director – Industrial Affairs (South

Asia), Sanofi comments, “The pharma industry recognises the benefits of renewable energy and is increasingly relying on alternate sources of energy such as wind and solar power to fulfill its energy requirements.” Debabrata Gupta, Director and Chief Operating Officer, USV notes, “The pharma manufacturing sector, specifically API manufacturing is energy intensive, where almost 40 – 50 per cent of the operating costs are related to energy. So, I believe that this

(

is a prime driver for reduction of energy usage and costs.”

Renewable energy Renewable energy is defined as energy that comes from resources which are naturally replenished on a human timescale such as sunlight, wind, rain, tides, waves and geothermal heat. Renewable energy can replace conventional fuels in four distinct areas: electricity generation, hot water/space heating, motor fuels, and rural (off-grid) energy services.

Solar energy Solar energy is a very popular source of renewable energy. Concentrated solar thermal (CST) technologies are considered as most relevant and efficient renewable energy technologies these days. Jasti explains, “In order to produce solar power during the day, one has to have a huge battery backup which is expensive; hence it is not viable for the pharma industry. The pharma industry especially which is into producing bulk drugs runs 24 hours. In event of a

power cut during the evening peak hours, solar power cannot be produced.” Rao elaborates how important and cost-effective renewable energy would turn out to be in the long run for the pharma industry. He says, “Investments in renewable energy can drive business value by helping companies mitigate the risks of rising energy costs and price fluctuations. Also, it leads to additional benefits such as improved quality and increased production which can lead to further

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E M AC I NU SF O C U S T H E MTAHI N FO

productivity gains.”

Initiatives Presently, though not many, some India-based as well as multinational pharma companies have installed renewable energy at their manufacturing sites. Rao highlights Sanofi's initiatives to introduce green measures as a part of their corporate culture and says, “As a global healthcare leader, we at Sanofi India are reducing our carbon footprint and using energy responsibly as part of our mission to help

protect life on this planet. We strongly support the use of renewable energy and continually seek to limit the environmental impact of our activities throughout the life cycle of our products. Present in India since 1956, Sanofi is amongst the few healthcare companies that explores the use of renewable energy sources for our manufacturing operations.” Gupta too shares his company's efforts and says, “We continuously evaluate energy

EXPRESS PHARMA

June 1-15, 2014

cover ) The pharma industry recognises the benefits of renewable energy and is increasingly relying on alternate sources of energy such as wind and solar power to fulfill its energy requirements Madhu Rao, Senior Director – Industrial Affairs (South Asia), Sanofi

The pharma manufacturing sector, specifically API manufacturing is very energy intensive, where almost 40 – 50 per cent of the operating costs are related to energy. So, I believe that this is a prime driver for reduction of energy usage and costs Debabrata Gupta, Director and Chief Operating Officer, USV

24 EXPRESS PHARMA June 1-15, 2014

consumption at all our manufacturing sites and look for obvious leakages. There are inter functional groups at each site, who constantly work at conserving energy in various forms. The other initiative that we have been successful at is to identify areas where waste heat could be recovered and used productively.”

Challenges Renewable energy can have positive and productive impacts on the companies' performance, so what hinders pharma companies from adopting alternate resources? Gupta too feels that the cost is a major factor which is hindering the industry from adopting green technologies. He opines, “It is usually the capital cost as well as the ability to install the suitable equipment, that comes as a hindrance.” Jasti informs, “We never considered going for renewable energy option and without the Government support it will be a very costly affair to think.” However, Gupta is keen on green technologies and sharing his company's corporate plans for adopting them, he says “There are no immediate plans to install solar panels in our facility. However, we are evaluating wind energy seriously through installation of wind mills. Wind mills need not necessarily be installed at the sites. In fact, they are most effective when installed in high wind areas around the country and then, in turn, connected to the central power grid.”

Government’s initiatives Government does give subsidies to promote such initiatives, though the percentage might vary from industry to industry. Rao points out, “The Government provides subsidies to the pharma sector for installing renewable energy, however, there exists

Alternative source of energy is required to curb the pollution and to save natural resources Venkat Jasti, Chairman and Chief Executive Officer, Suven Life Sciences

a huge scope for the simplification of the process and implementation of regulatory systems that will act as an incentive to the pharma companies and encourage them to install renewable energy.” Jasti feels that these endeavours will have a positive impact in the long run and says, “Alternative source of energy is needed to mainly curb pollution and to save natural resources.”

minimise the consumption of non-renewable resources, which are getting depleted day-by-day. Effectively harnessing the huge potential of renewable energy resources is very important to cope with the growing scarcity of conventional energy sources. The pharma industry also needs to take a stand and adopt a more environment-friendly approach to keep up its progress.

Moving forward It is the need of the hour

u.sharma@expressindia.com

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AC I NU SF O C U S T H E MTAHI E N M FO

I N T E R V I E W

‘The CST technology is an idea whose time has come’ Abhishek Bhatewara, Director, Sales and Marketing, Clique Solar highlights the importance of adopting renewable energy at manufacturing sites and speaks about its monetary and long-term benefits, with Usha Sharma

What is the importance of solar steams in the pharma industry? The pharma industry produces multiple products in the form of tablets, capsules, ointments, liquids and powder. The manufacturing processes are energy intensive and the requirement of thermal and electrical energy varies depending on the product. The thermal energy requirement typically consists of low pressure steam (~ 5 bar, 150°C) and hot water (60 – 80°C). Some of the industries also require hot air at 60 – 80°C in large quantities. These temperature ranges are suitable for the integration of solar thermal systems in the process. Two typical processes in pharma industry that require heat in some form are sterilisation and granulation. Concentrated solar thermal (CST) technologies are the most relevant and most efficient renewable energy technologies for these as the solar energy is used to convert water into steam and hot air directly.

Sterilisation All the equipment used for pharma processing as well as active pharmaceutical ingredients (APIs) need to be sterilised. Different types of sterilisers e.g. steam steriliser, dry heat steriliser, sterilising tunnel, Cleaning in Place

(CIP) System , Sterilisation in Place System (SIP) use heat in different ways. Sterilisers can use either hot air or steam for sterilisation of the products (medicines). The hot air is used generally at 160°C at least for two hours. The sterilisers that use steam have pressure range up to two bar-121°C.

Granulation Granulation is a size enlargement process which converts small particles into physically stronger and larger agglomerates. There are several types of granulation processes e.g. wet granulation, fluid bed granulation, spray drying granulation etc. The granulation process typically requires hot air at 60-70°C at very high flow rate up to 250 m³/hr. Globally, what percentage of solar steam is used in the pharma industry? CST industry is not very new in the country and globally. Hence, only a few research initiatives have been undertaken so far. As of now, there are no credible figures on the penetration of CST technologies in the pharma sector in India or worldwide. Yes, there is a study on the potentiality of the sector. A study conducted jointly by Ministry of New and Renewable Energy, GIZ and Federal Ministry for the

Factors that have worked for us tremendously until now with other segments are performance guarantee, efficiency and space benefit

Environment, Nature Conservation and Nuclear Safety, Germany identifies the pharma sector as one of the top 10 sectors in India in terms of potential of application of CST technologies. Most of the thermal energy applications in pharma units require low-range temperatures which are easily achievable by solar energy applications. It has been observed that approximately 20 per cent of the total energy consumption in the units within the sector is due to heat load. Based on certain empirical analysis it was determined that five per cent of the heat load could be suitably replaced by solar energy applications. The potential is unquestionable. Are there any laws in place for solar steam usage in the developed markets? World over there are different regulations regarding the usage of renewable energy technology. The same exists in India as well. However, these regulations exist on using any form of renewable energy. In our view there is no clear mandate to use any particular technology. What services do you offer to the Indian pharma companies and how cost effective are they?

We are in the domain of CST. This means that we heat water, convert water into steam/hot air by using solar energy directly. We are proud to have India’s only patented technology in the CST domain – ARUN. It is the only CST technology that has proven that temperatures upto 300° C /upto 20 bar pressure is reachable and yet remain commercially viable for an organisation. It has been developed after research of almost a decade keeping the specific requirements of Indian industries in view. As compared to any other technology, ARUN scores high on all aspects of technology, efficiency, ease of implementation and integration, maintenance and payback. What are the key features of Arun? Footprint area: The ARUN solar thermal concentrator has a small footprint area of (3m x 3m per dish). This enables it to be mounted at locations which have space limitations. It can also be erected on rooftops of existing buildings. Performance guarantee: Clique Solar guarantees the performance characteristics of ARUN concentrated solar thermal system, also known as a solar boiler dish. High temperature and

EXPRESS PHARMA

June 1-15, 2014

cover ) pressure delivery: ARUN can operate up to 300°C (oil) and 20 bar (steam). Government subsidy: Ministry of New and Renewable Energy (MNRE) provides support by way of capital subsidy or soft loans for every ARUN solar boilers. Clique solar is the channel partner with MNRE. Non-solar hours operations: ARUN solar thermal concentrator dish can be augmented with a heat energy storage facility for operation in non-solar hours. IBR approval: ARUN concentrated solar thermal system is the first IBR approved solar boiler in India. High wind bearing capacity: ARUN dish is designed to operate in wind speeds of up to 10 m/s and it can survive in wind speeds of up to 47 m/s. High net energy gain: The net energy gain (i.e. energy gained from energy source – energy expended in harvesting the energy source) of ARUN solar thermal concentrator dish is amongst the highest in solar for industrial process heat (IPH) manufacturing industry. Clique Solar is specialised in areas of sterilisation and granulation through solar hot air. Could you explain the importance of having a presence in these niche areas? We provide steam to industrial processes. The segment where heat is required to complement processes of production is called IPH. Our niche is in providing IPH though solar energy, thus saving cost for companies in the short term and insulating them to the impact of rising fuel costs in the long run, as well as helping them strengthen their green initiatives. Thus, in any industry where processes require heat, ARUN technology finds potential application. Hence, the specialisation is not in sterilisation or granulation, but in providing heat required in industry processes through

26 EXPRESS PHARMA June 1-15, 2014

solar energy. Processes in pharma industry like granulation and sterilisation use hot water / hot air / steam which can easily be provided by using solar energy. The importance of being present in this segment can be understood well if we consider the energy usage in IPH processes that is generated using expensive fuels. IPH applications below 250°C contribute to about 15 to 20 per cent of India’s total oil consumption (almost 80 to 90 per cent of which is imported). If we convert this amount into foreign exchange spent in buying this fuel, it comes to $8 billion. Hence, the industry

maintenance charges applicable) for the rest of the dish life. Contrast this with the rising fuel costs and you have your answer. As far as reduction in CO2 emission is concerned, ARUN 160 saves 60-70 tonnes annually. Who are your main clients in India? Our clients include NETRA (NTPC facility) – Greater Noida, Swaminarayan Akshardham –Delhi, Mahindra – Pune, RKM Students Home – Chennai, Chitale Dairy - Delhi, TEL – Chennai, ITC Maurya Hotel – Delhi, Mahananda Dairy – Latur, and CMC Vellore.

industry). This is compounded by financing challenges as banks across the country are still evaluating the risks to fund projects in this area. We have a two-pronged approach in reaching out to potential clients. We are building a network of experts / consultants across cities who engage with the pharma companies and working with the MNRE to spread word through conferences, workshops and other awareness generating exercises. We are also using social media in a great way. Our website is regularly updated and we receive a lot

Our niche is in providing IPH though solar energy, thus saving cost for companies in short term and insulating them to the impact of rising fuel costs in the long run, and helping them strengthen their green initiatives has a lot of potential for the performing technologies. Cooling and air conditioning is another energy intensive process amongst the various energy consuming applications where CST has an application. We already have two projects installed and working in this segment. How cost effective and environment-friendly are these solutions? We can talk about ARUN technology as we can take ownership of the claims made for it. The proposition becomes quite attractive for a company if liquid or gaseous fuels are being used. This is because payback period for such installation range between two and half years to five years (depending on the location, usage, kind of fuel used. Once the payback is achieved, a company receives almostfree fuel (minimal

What regulatory approvals do you have for the pharma products? Since, we are the channel partners with MNRE, it means that not only we are authorised as commercially proven, we can also take off the burden of subsidy from our clients’ books. We can claim the government subsidy directly once the ARUN system is installed and performing. The only other regulatory approval we need is on the boiler part of ARUN system. What marketing strategies have you planned to encourage Indian pharma companies to opt for solar sterilisation and granulation system? The biggest hurdle in the adoption of solar thermal technologies is awareness and confidence amongst adopters (clients and technical consultants to the

of queries through it. In the past we have used Google Hangout to conduct online conferences. With support from the MNRE and the United Nations Development Programme (UNDP) we organised the first ever online CST conference on World Environment Day last year (2013). The Government has also undertaken the MNRE – UNDP programme to spread awareness about the industry by asking for proposals for demonstration and replication projects. The Government will provide additional subsidy for these projects and make these reference projects for the industry. Solar energy policies of the Indian states are also helping immensely in raising awareness and promoting adoption of solar energy technologies that are commercially viable.

How are you stepping into pharma sector? We are yet to get a pharma client. Talks are on and we expect to convert a few very soon. Factors that have worked for us tremendously until now with other segments are – performance guarantee, efficiency and space benefit. Also, the type of fuel being used directly affects the motivation to adopt solar energy technology, if cost is a consideration. If the fuel being used to generate heat is LPG, furnace oil, diesel or PNG, it makes for a highly favourable case for the adoption of a solar thermal technology. On top of that, companies get MNRE subsidy and tax benefit provision in wake of 80 per cent accelerated depreciation. Will the pharma industry adopt renewable energy in near future? If seen in the right context – ‘not installing a concentrated solar thermal system’ only proves to be costlier. It has two parts to it. Firstly, the alternate fuel we use is furnace oil, which was our main fuel or only fuel prior to installing solar thermal systems. Spending on furnace oil is also costly, which is increasing at a good rate. Full or a part of this cost can definitely be reduced if a renewable technology is used. The more you delay it the more you are paying for furnace oil or LPG. Remember cost of LPG is not recoverable. While cost incurred in renewable energy technologies is recoverable. Secondly, the CST technology is an idea whose time has come. So, the more a company delays it, cost of notinstalling the CST system is also increasing. All the extra money spent on diesel or LPG is the cost that a company could have saved had it installed the CST system earlier. And, whenever you install a CST system, it is more or less going to cost you the same. u.sharma@expressindia.com

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AC I NU SF O C U S T H E MTAHI E N M FO

NEWS

Frost & Sullivan hosts 5th edition of ‘Green Manufacturing Excellence Awards and Summit’

toward considering sustainable 'smart' business models that integrate each of the requirements be it resources, waste, energy, supply chain, into the long-term planning and vision of the organisation.” GMEA&S, this year, also saw the introduction of the Safety Excellence Model that took companies through a detailed safety assessment built on five broad parameters (Safety Management Systems, Process Safety, Equipment Safety, Employee Safety, and Occupational Health). These five parameters were further divided into subparameters that evaluate and map their journey from a reactive to a proactive safety approach. A detailed feedback on the maturity of a company’s safety system was shared in addition to the GMEA report. The highest scoring companies were recognised for ‘Excellence in Safety’ during the 2014 Green Manufacturing Excellence Awards banquet. EP News Bureau-Mumbai

EP News Bureau-Mumbai

‘Believers Award’ winners at ‘The 5th edition of Frost & Sullivan’s Green Manufacturing Excellence Awards 2014’

lays emphasis on identifying long-term sustainability risks, and an organisational approach to address these issues. Various metrics ranging from sustainable strategy to safety systems, from environmental management to social accountability, are tracked through this platform. Surya Bansal, Programme Manager- Sustainability Initiative, Frost & Sullivan said, "Sustainability as an integrated strategic tool is a very new to the country and is at a nascent stage in pharma companies. Globally, the big players in the pharma sector have been talking of the responsibilities and environmental stewardship for quite a few years now. There are challenges that they face, be it with pharma in the environment (PIE) or responsibility towards the use of the medicines and have faced intense pressure from stakeholders to look at sustainable practices. Companies like AstraZeneca, Bayer, Pfizer, etc. for example, are looking to see how to use innovation, technology and community involvement to

bring in sustainable manufacturing practices, be it looking at concentrations of APIs in the environment (both short and long term), use of natural enzymes or harnessing green energy.” Nitin Kalothia, Director, Manufacturing and Process Consulting, Frost & Sullivan said, “Based on our assessments, we have seen companies like Dr Reddy's Laboratories, Abbott Healthcare, Sentiss Pharma, Piramal Healthcare and USV, who have been leading the sustainability journey in the pharma sector.” Kalothia highlighted, “During the assessments for GMEA the key finding has been that sustainability for most companies have been initiative driven. The focus areas for these companies have been energy management, material, and products which directly impact the bottom line of the company. There needs to be a shift in this concept as the low hanging fruits that come with an initiative based approach would soon dry out. The shift has to be

n order to enhance sustainability within the supply chain the chemical companies AkzoNobel, BASF, Bayer, Clariant, Evonik Industries, Henkel, LANXESS and Solvay joined forces in the Together for Sustainability (TfS) initiative. So far, TfS members have successfully initiated about 2,000 assessments and audits. In 2014, TfS is expanding its activities in high growth sourcing markets, including Brazil, China and India. TfS aims at developing and implementing a global supplier engagement programme that assesses and improves sustainability sourcing practices, including ecological and social aspects. The initiative is based on best practices and builds on established principles – such as the United Nations Global Compact (UNGC) and the Responsible Care Global Charter as well as standards developed by the International Labor Organization (ILO), the International Organization for Standardization (ISO) and Social Accountability International (SAI). The TfS initiative involves assessments and audits of suppliers by independent experts. 2014 marks the next phase of the initiative’s global roll out to additional sourcing markets and a further growth of TfS membership. There are several benefits for suppliers participating in the TfS initiative. Sharing information with multiple customers reduces the number of double assessments and audits, and as such significantly reduces time, resources and overall costs.

Three pharma companies featured in the Green Manufacturing Excellence Awards’ roll of honour this year rost & Sullivan recently concluded its 5th edition of the ‘Green Manufacturing Excellence Awards and Summit (GMEA&S)’ in Mumbai. The event comprised Green Manufacturing Excellence Summit where organisations that have worked on their sustainability gathered under one roof. Best practices from companies across industries that participated in the award platform were shared by notable industry stalwarts who play an integral role in the field of sustainability in India. The focus was on aligning sustainability initiatives with the business model and creating sustainable 'smart' business models. The common message brought to the fore by these companies was that in order to create success stories it is imperative for financial inclusion to be one of the cornerstones of the language of sustainability. Three pharma companies featured in the Green Manufacturing Excellence Awards’ roll of honour this year. In the Believers category, Sentiss Pharma’s Nalagarh facility and USV’s Unit II at Jharmajri received awards in the Medium Business segment while Piramal Enterprises’ Digwal facility received a Certificate of Merit. USV's Unit II at Jharmajri also received a Certificate of Merit in Safety Excellence. This year, eight per cent of the companies that were short-listed for final assessment were from the pharma sector. GMEA, through this mission,

Chemical companies join hands for TfS initiative

EXPRESS PHARMA

June 1-15, 2014

cover ) INSIGHT

BRIDGING

VICKRAM JADHAV, Vice President, Fortum India

THE ENERGY DEFICIT Vickram Jadhav, Vice President, Fortum India explains how the pharmaceutical industry can benefit from Combined Heat and Power systems

harmaceutical s are a $30 billion industry in India, made up of formulations (65 per cent) and bulk drugs (35 per cent) by value. The figures clearly show the exponential growth the pharma industry is witnessing. It is a highly fragmented industry, with 350 units constituting the organised sector (7580 per cent value). The remaining 20 per cent consists of a large number of very small firms. Volume-wise, for-

28 EXPRESS PHARMA June 1-15, 2014

mulation units represent 77 per cent and bulk drugs units constitute the rest. Pharma sector consumes about 13 TWh of thermal and 5 TWh of electrical energy, including their requirement for cooling at the level of 3.7 TWh. While a large amount of thermal energy is required for bulk drugs manufacturing, a relatively smaller amount is consumed by formulations manufacturing. Unlike other industries, many pharma

boilers are powered by electricity rather than coal or gas to meet ambient air quality requirements of the US Food and Drug Administration (FDA). Even the cooling equipment runs on electricity. Other electricity needs, for operating machinery and lighting, etc. are relatively small. Energy requirements also vary depending on the size of the plants. The industry is growing at 14 per cent per annum, driven by high export volumes and is

expected to continue to grow at the same pace in the future . It has very limited CHP penetration presently, which can potentially grow given the high energy demand from this industry and the fact that many of the plants are situated together in clusters and require heat (or cooling) in their manufacturing process currently using heat-only-boilers (HoB), electricity, and other methods to fulfill their heat requirement and hence they can employ

efficient CHP systems. Developing CHP systems to meet the requirements for thermal energy can help generate on-site power at double the efficiency. Energy security has been identified as one of the critical challenges to Indiaâ&#x20AC;&#x2122;s growth and bridging the energy deficit by increasing system efficiency and moving towards more diversified and cleaner energy sources is going to be the key priority also for the

( pharma industry with a global exposure in India. The increasing energy demand is challenging for India in view of problems such as fuel scarcity, raising costs of fuels imports, increasing emissions, high AT&C losses, lack of distribution reforms, and lack of new investments. While the country is taking definitive steps to overcome these challenges, higher energy efficiency and increased fuel flexibility will be vital for this industry to meet the rising energy demand. Although the power generation capacity in India has grown at an impressive pace over the last decade, India’s power production is not enough to meet the base-load demand from its industrial, agricultural, domestic and commercial users.. Experts forecast that India will need a threefold increase in power generation by 2032 to achieve targeted long-term GDP growth rates. At the same time, the amount of fuel being used for industrial process heating is expected to grow in the same magnitude. More than 30 per cent of coal and 40 per cent of gas in India is already today consumed to meet industrial demand for heating and cooling. Co-generation i.e. Combined Heat and Power (CHP) systems can help overcome some of the challenges connected to the ever increasing demand of energy. CHP systems make use of energy – that in conventional applications is wasted and thereby increase the total system efficiency substantially.

What is Combine Heat and Power (CHP)? Combined Heat and Power (CHP) is a simultaneous production of electricity and heat, in India usually referred to as 'co-generation'. Heat can be used as heat, steam or cooling (generated through absorption processes) depending on the need and application. A fundamental principle of co-generation is that, in order to maximise the system efficiency, the systems should be designed

(

T H E MTAHI N E M FO AC I NU SF O C U S

CHP OFFERS SEVERAL TANGIBLE BENEFITS FOR INDIA, SUCH AS A STRONGER TRADE BALANCE, INCREASED COMPETITIVENESS AND LOWERED EMISSIONS ■ It reduces the use of primary resources (coal, oil, diesel) considerably because of higher efficiency of energy generation processes. ■ It enables a shift towards local, domestic biofuels and waste thanks to flexible technologies and local character of the plants. . ■ It reduces emissions (e.g. CO2, SO2, NOx, and particulates) as one efficient plant with good combustion and flue gas cleaning is used to substitute small scale industrial steam boilers. ■ It provides all the benefits of distributed generation, including fewer AT&C losses and less grid congestion. ■ It increases the competitiveness of the sector by providing cost-efficient, simple and reliable energy solutions. ■ Since the foundation of the CHP concept is co-generation of heat and electricity to improve efficiency, it is important for the industry to think of setting up heat networks (e.g. steam pipelines) to encourage the development of CHP plants in the country. This could very easily be taken into account and implemented for upcoming industrial clusters and can go a long way in encouraging CHP installations and increase market penetration. Fortum has decades of experience in building and operating heat networks.

COMBINED HEAT AND POWER (CHP) PLANT IN INDUSTRIAL CLUSTER

Figure 1: Illustrative benefits of a CHP plant with 75 per cent efficiency: Conventional centralised electricity generation and on-site heat generation has a combined efficiency of about 45 per cent after accounting for the 35 per cent efficiency of power generation, 20 per cent AT&C losses and the 70 per cent to 75 per cent efficiency of the low pressure heat-only-boilers. CHP systems, in comparison, can reach efficiency levels of up to 90 per cent

based on the heat demand of the end user – an individual building, industrial facility, cluster of industries or city where district heating or cooling infrastructure could be developed. Surplus electricity can be fed into the local network but heat produced in the process needs to be consumed locally. By locating small- to medium-sized power plants to serve industrial or commercial demand for steam, heat or cooling, it is possible to optimise the energy system so that steam or heat from the power production process can be used to substitute individual steam boilers and traditional air conditioning units. In this way, the CHP system can be 60-90 per cent more energy efficient than a separate generation of electricity and heating/cooling, (see Figure 1). Another type of a CHP plant is where excess heat from an industrial unit is used to produce power. This is done, for example, by the steel industry where blast furnace gas is used for producing power onsite through a waste heat recovery unit. Since CHP plants are designed to fit the thermal demand side, e.g. the steam demand of an industrial cluster or cooling demand of a district cooling system, the optimal scale differs between applications. Community CHP systems can aggregate heat requirements of clustered, but fragmented applications and provide a common solution. For typical industrial and commercial purposes in India, the size spans from a few MWs up to approximately one hundred MW of electricity. There are many different technologies used at CHP plants and they are classified based on the type of fuel they use (e.g. gas, coal, diesel, biomass or waste) and by the type of power producing system installed (e.g. steam turbine, gas turbine, gas motor, diesel motor). CHP plants with steam turbines can be built with flexible boiler systems so that multiple fuels can be used.

EXPRESS PHARMA

June 1-15, 2014

MANAGEMENT

M&AFRENZY IN PHARMA: HERE TO STAY? Mergers and Acquisitions (M&As) within the Indian pharmaceutical industry is not a new phenomenon. However, the deal between Sun Pharma and Ranbaxy is different in a way that it has certainly paved the way for more such M&As in the future BY SACHIN JAGDALE

30 EXPRESS PHARMA June 1-15, 2014

ergers and Acquisitions (M&A) seem to be the flavour of the season. Sun Pharma took over Ranbaxy and Bayer acquired Merck's consumer healthcare business. Pfizer bidding for Astrazeneca in what could be more than a $100-billion takeover offer, has also been in the news for quite some time. Leading manufacturer of generic drugs, Teva Pharmaceuticals persistent attempts to acquire Cipla has been a topic of discussion in the industry. The surge in M&A activities, is expected to have a significant impact on the way the Indian pharma industry would shape up in future.

M&A drivers Though recent months have seen a spur in M&A deals, the reasons and motives behind each one of them vary. KV Subramaniam, President and Chief Executive Officer, Reliance Life Sciences, analyses the development and says, “M&A activities have certainly accelerated in the first four months of this year, with several big ticket deals announced or are being currently pursued. Big pharma companies, who have largely stayed away from large deals in 2013, are looking at M&A route to expand into new product categories, new geographies and new technologies, besides focusing on growth in revenues and profits.” He adds, “The focus now is more on the larger market opportunities, whereas, earlier it was directed at acquisitions of innovation-driven start-ups for technology platforms and early stage development product companies.” Patent protection was ensuring good profits to the innovator companies. However, post patent expiry profit margins started sinking considerably and pharma companies had to look for other avenues and alternate resources to earn money and stay afloat. This situation proved to be a precursors for the rise in M&A activities in the global pharma industry. V Krishnakumar, Partner, Transaction Advisory Services

-Lifescience & Healthcare, Ernst and Young, informs, “As the global blockbuster boom of the 1980s and 1990s ran out of steam and patent expiries started accelerating, big pharma has been forced to cut down on inefficiencies and focus on core competencies. Hence, there has been (and will continue to be) significant consolidation in the global pharma industry.” He adds, “This consolidation is enabling the rationalisation of various aspects of the business including product portfolios, R&D operations, manufacturing operations and investment on new product pipelines.” Ameesh Masurekar, Director, AIOCD Pharmasofttech AWACS, informs that the driving factors behind M&As globally and in India are quite different. He opines that Daiichi may not have had pressing reasons to exit from Ranbaxy at such a low valuation if it had been a purely domestic Indian company. He states, “Globally, the blockbuster molecules are reducing in every decade. This has led to increased pressure on sales, marketing, manufacturing and all other indirect costs.” He further claims that the recent M&As were an attempt to maintain the bottomline, and reduce costs rather than to increase the topline. Sun and Ranbaxy deal is unique because of its valuation, its supposed ability to enhance topline purely because of the merger and its potential to reduce costs as well. “The pharma industry globally is going through a challenging time with increasing public scrutiny and immense pressure on pricing,” feels Ranjit Shahani, Vice Chairman and Managing Director, Novartis India. He says, “M&As is one way for pharma companies to gain scale and have a strategic position in the market place as can be seen from recent examples where companies have

The focus now is more on the larger market opportunities, whereas, earlier it was directed at acquisitions of innovation-driven start-ups for technology platforms and early stage development product companies KV Subramaniam, President and Chief Executive Officer, Reliance Life Sciences

The pharma industry is highly fragmented and clearly has been ripe for consolidation for quite some time. These recent M&As are clear indicators. There is always the possibility that there could be more M&As in the Indian pharma space and of course globally Ranjit Shahani, Vice Chairman and Managing Director, Novartis India

either bought out brands, formed JVs or divested businesses that are not among the top three in the market. In some cases, companies have bought out stressed assets in an endeavour to turn those around and gain market share.”

A trend setter deal? Ranbaxy's acquisition by Sun Pharma is perhaps the most significant acquisition in the Indian pharma industry. However, experts do not deny the chances of more such acquisitions. “Several M&A deals have happened in India involving MNCs as well as Indian acquirers in the past and we expect this trend to continue,” informs Subramaniam. Masurekar echoes Subramaniam's views and explains, “Ranbaxy and Sun Pharma deal will open the doors for several more acquisitions in India. The buyer may be an Indian company or an MNC.” He adds, “The Daiichi acquisition of Ranbaxy was at five to six times the sales and Piramal acquisition of Abbott was at eight to nine times the sales. Due to these two deals there were high expectations and it was difficult for any buyer to match these. Now, with this deal, the expectations would be realistic, a new benchmark has been set and this would eventually open up more prospects for M&As.” Krishnakumar also endorses the views of Subramaniam and Masurekar and says that the trend of M&As will continue. Discussing the rationale behind his views he says, “Indian Big Pharma has definitely become an attractive buyer universe for prospective Indian sellers over the last one to two years, because of the heightened regulatory scrutiny involving the sale of Indian pharma companies to MNCs. Besides, the case for domestic consolidation is becoming more and more significant in the context of heightened drug price controls.”

Domestic consolidation will help in keeping drug prices under control. However, multiple branded generic versions of new molecules will act as an obstacle in doing so. Krishnakumar explains, “Over 100 companies launch and try to promote their branded generic versions of each new molecule, which results in an enormous amount of wasteful activities and expenses in terms of manufacturing, distribution and doctor promotion. It also creates an unnecessary logjam of paperwork for regulatory authorities such as the State FDAs, DCGI, etc. Ultimately only the top 10-15 companies succeed in building large brands.” He adds, “We need to see more domestic consolidation happen so that the inefficiencies in the industry can get minimised, which in turn will increase the ability of pharma companies to provide cheaper drugs to patients without having to sacrifice profits. We believe that having eight to 10 companies selling a molecule provides for adequate competition; we don't need to encourage the launch of 100+ brands for each molecule.” Shahani says, “The pharma industry is highly fragmented and clearly has been ripe for consolidation for quite some time. These recent M&As are clear indicators. In life there are no permanent competitors so there is always the possibility that there could be more M&As in the Indian pharma space and of course globally.” According to Sun Pharma spokesperson, each situation is very specific. Whether it will spark off a trend is difficult to say.

Potential targets Pharmemerging markets like India are considered to be the next big ground for M&A activities. It will be interesting to see the kind of Indian companies that are going to be the targets of potential bidders. Subramaniam says, “Against the backdrop of subdued growth in developed markets such as the US and the EU, pharmemerging markets continue to show a robust

EXPRESS PHARMA

June 1-15, 2014

MANAGEMENT

Indian Big Pharma has definitely become an attractive buyer universe for prospective Indian sellers over the last one to two years,

M&As are very beneficial to us. They give us an opportunity to create an environment conducive to new requirements

V Krishnakumar,

Archana Sohoni,

Partner, Transaction Advisory Services -Lifescience & Healthcare, Ernst and Young

growth. This would be one of the key reasons for M&A deals in these markets. The other reasons could be access to lowcost R&D or manufacturing base which would help the acquirer company to cut costs aggressively and achieve synergies with its existing business.” According to Krishnakumar, two categories of Indian companies are likely to be the targets for potential bidders. He says, “The first category would consist of companies who have low-cost and worldclass R&D as well as manufacturing capabilities, such that potential bidders can leverage the Indian infrastructure as global (or regional) supply bases. The second category would consist of companies who have market-leading positions in the domestic branded formulations market, in highgrowth chronic specialities like cardiology, endocrinology, chronic pain, chronic respiratory and oncology.” According to experts, more M&As will happen in future, however, bidding for the pharma companies in the emerging markets like India, also involves post-acquisition risks/challenges. Masurekar explains, “More than which Indian company would be the target, the key question will be

32 EXPRESS PHARMA June 1-15, 2014

Principal Architect, Arena Consultants-

who would be interested in a buy-out. MNCs have done big ticket, premium buyouts but looking back they feel the deal was not worth that valuation, as post buyout they have struggled to beat the pharma market growth rate. So on the buyer side, that leaves out some top Indian companies looking to consolidate and some MNCs who have a research pipeline in specific niche areas but have not fully entered into India.” According to Masurekar, options available are licensing the drug to a leading Indian player and enjoying royalties or fully entering into India with a field-force, the second of which will open a buy-out option rather than rebuilding from scratch.

Mixed package for service providers Service providers of the pharma industry will also be directly getting affected by the M&A deals in the pharma industry. Archana Sohoni, Principal Architect, Arena Consultants, says, “M&As indicate growth, expansion. Whatever strategy a company would prefer to adopt, the outcome is a change towards progress. The effect of M&As is change in company policies, resources, operations,

If the merged entity changes the business focus and decides to stop certain ongoing projects or reduces its scope,it can adversely affect service providers

The recent M&As were an attempt to maintain the bottomline, and reduce costs rather than to increase the topline Ameesh Masurekar,

Such consolidations can enable the Indian pharma industry to initiate more projects of drug discovery, thereby creating more opportunities for CROs. Narendra Deshmukh,

Director, Labguard India

Director, AIOCD Pharmasofttech AWACS

market share, revenue, infrastructure etc.” Arena Consultants are laboratory planners and designers. For a service provider like them, it means they are prospective clients. It is a favourable event for them. “For us it translates into building infrastructure to a scale bigger than the existing one or rebuilding the existing set up to suit new requirements. When two companies come together in whatever format, change in company culture is inevitable. There are hierarchies or matrix patterns which need to be reflected in company layouts. Many times companies decide to go for accreditation to attract foreign investors or buyers. So the accreditation process governs the layout and infrastructure planning,” says Sohoni. She adds, “New divisions are set up. Each R&D head or user has his own way of working. In that case the layouts change. In addition to this, with globalisation, there is lot of awareness in work environment. Researchers, analysts, technicians travel to their Western counterparts, see their infrastructure and aspire to have similar set-ups. This too influences our work. Thus M&As are very beneficial to us. They give us an opportunity to

create an environment conducive to new requirements so that it helps the company reach higher goals than before.” Intox Labs, Pune, does toxicology studies for the pharma companies. Consolidations in the pharma industry would benefit CROs like Intox, feels Narendra Deshmukh, Director, Intox Labs. He says, “Such consolidation can enable the Indian pharma industry to initiate more projects of drug discovery, thereby creating more opportunities for CROs. For routine regulatory studies, ongoing M&As could further widen pipelines thereby increasing the opportunities.” Salil Sansare, Director, Labguard India, opines, “The merged/acquired entity looks for expansion/modernisation of its plants/R&D centres. It definitely creates more opportunities for service providers- it can be a green field project or a total revamp of existing facilities. Also the new entity may ask for a lot of global compliances, which means the service provider can implement latest technologies which will benefit customer in cost and speed.” However, service providers may also have challenges to deal with. M&A deals would encourage sharing of resources between the pharma companies

which may reduce the need to hire service providers for different purposes. Sansare points out another challenge and says, “If the merged entity changes the business focus and decides to stop certain ongoing projects or reduces its scope, it can adversely affect service providers.”

Salil Sansare,

Director, Intox Labs

In times to come Sun Pharma-Ranbaxy acquisition deal was unique in a sense that it was the largest such deal that took place between two Indian pharma companies. Though experts have predicted more such consolidations in future, a section of the industry also feels that in future the Indian pharma companies would be in a position to take on MNCs. In fact, as pointed out by Shahani, the world has changed and today you have Indian companies that have acquired global companies in other sectors. We need to change our mindset and be open to what is best for all stakeholders, particularly the patient. Looking at ever growing pharmemerging markets, a time will come when a Indian pharma company would pocket a pharma MNC. sachin.jagdale@expressindia.com

MANAGEMENT INSIGHT

Outsourcing now and into the future — An animal health story

ARUN RAMESH, Senior Research Analyst, CMO Formulations, Beroe

Arun Ramesh, Senior Research Analyst, CMO Formulations, Beroe in this whitepaper seeks to explore the growth of outsourcing and contract manufacturing in the animal health industry DECLINING REVENUES due to patent cliff and increasing competition in the human health division have initiated pharma MNCs to look into alternative options like expanding their animal health and consumer care businesses. Traditionally, animal health drug manufacturers have relied on keeping most of the drug production in-house, with outsourcing accounting for only five to 10 per cent of the total animal health drug production. However, with an increase in sales of generics and rapid growth in key therapeutic areas such as antibiotics and parasiticides, the percentage of drugs outsourced is expected to grow significantly in the future. Outsourcing in animal health industry is expected to reach 20-25 per cent by 2018 owing to growth in generics and therapeutic categories like antibiotics and vaccines.

Outsourcing in the animal health industry – Past and current scenario The global market for animal health products was at $22 billion in 2012 and is expected to reach $43 billion by 2018 at a growth rate of five to six per cent (as illustrated in Figure 1) By geography, the North (US) and Latin America (Argentina and Brazil) account for the largest share of the animal health drug market (47 per cent share by value), followed by Europe (France, Germany, Spain and the UK) with 31 per cent share and ROW (India, China) with 22

per cent share. The industry can broadly be categorised by the type of animal and comprises the following chief segments - livestock (cattle, poultry and sheep), companion animals (cats and dogs) and equine (horses). As of 2013, livestock animals accounted for 59 per cent of all drug sales, followed by companion animals at 41 per cent of total sales.

Animal health vs. human health – A comparison

GLOBAL ANIMAL HEALTH MARKET

Unlike human drug outsourcing (17-20 per cent outsourced), the outsourcing percentage of animal health drugs is five to 10 per cent. The low outsourcing rate is attributed to minimal generic penetration and lack of technological capabilities. Though most companies prefer to manufacture drugs in-house, Figure 1

EVOLUTION OF IVERMECTIN FORMULATIONS ACROSS DIFFERENT SPECIES

Figure 2

EVOLUTION OF DEXAMETHASONE FORMULATIONS ACROSS DIFFERENT SPECIES

Figure 3

EXPRESS PHARMA

June 1-15, 2014

MANAGEMENT the above two reasons have forced them to outsource to companies specialising in animal health drugs. A company is said to achieve approximately 20 per cent cost saving by outsourcing. Table 1 compares patent term, pricing and outsourcing per cent in human and animal health industry

Saturation in the innovation market – A driver to outsourcing Many of the innovator drugs have been fully explored covering more than 90 per cent of the dosage forms (injectable, tablets, gel, ointment, powder) aligned to different species like cattle, swine, poultry, cats, dogs, and horses till date. This has resulted in the shift towards branded generics and generics, thereby luring pharmaceutical companies venture into generics. Figure 2 and Figure 3 are two examples where a company launched drugs in different dosage forms across different species and this was followed by other major companies with the same APIs in different dosage forms catering to different species in the forthcoming years and benefited three years market exclusivity.

WHAT WOULD BE THE MAJOR FACTORS INFLUENCING OUTSOURCING IN THE ANIMAL HEALTH INDUSTRY?

■ Increase in awareness for drugs

■ Therapeutic category as a driver

among animal owners and their lookout for low cost generics, increase in the approval rate of generics from 18 per cent (20072011) to 35 per cent (2012-2013) are expected to trigger the growth of generics from 20 per cent in 2012 to 30 per cent by 2018 (by volume)

for outsourcing, antibiotics and vaccines are expected to grow at nine to 10 per cent and three to four respectively by 2018. Inadequate in-house technological capabilities and lack of dedicated facilities among the pharma companies would intensify outsourcing to contract manufacturers

ANIMAL HEALTH OUTSOURCING EVOLUTION AND FUTURE OUTSOURCING TREND

Future of animal health outsourcing The animal drug market is saturated with innovator drugs encompassing all the prominent species. Despite drug availability in the past, with market reaching the saturation in innovator drugs, more generics are expected to penetrate the market. Figure 4 depicts the percentage shift in industry outsourcing due to market saturation of innovators and penetration of generics. Drugs in therapeutic categories like antibiotics, parasiticides involve high technological requirements like BFS (Blow, Fill and Seal), Ribbon blenders, Lyophilisers etc. Drugs (innovator and generic) in this category have been outsourced to contract manufacturers in the past. Thus with more generics expected in these categories

34 EXPRESS PHARMA June 1-15, 2014

Figure 4

Figure 5

MANAGEMENT TRANSITION FROM IN-HOUSE TO OUTSOURCING

Figure 6

Factors

Patent term of drugs

Human health

Animal health

20 years

5 years

Overview

Any company in the animal health business can launch a new drug with the same API but in a different dosage form and to a different species of animals. By this these companies get a marketing exclusivity of three years. This product is still considered an innovator

Outsourcing percentage

17 to 20%

5 to 10%

In US, percentage of generics is 70-80 per cent by volume in human health and 14-20 per cent generics in animal health. This is a reason for a low outsourcing percentage in animal health industry

Price of generics

70% less

50% less

Intensity of rivalry is low in animal health. In human health, price of generics is less compared to animal health because there are few companies to compete with, in the animal health space

pharma companies would outsource manufacturing to contract manufacturers. Figure 5 illustrates how vaccine and antibiotic market is said to drive animal health outsourcing

Transition from in-house to outsourcing Till recent past, 90 per cent of the product portfolio of top pharmaceutical giants like Pfizer, Sanofi, and Merck were innovator drugs and these drugs were manufactured inhouse. Some of the branded generics of these companies were outsourced to contract manufacturers. Moving forward, market saturation of innovator drugs would lead to increase in generics, thereby driving outsourcing of animal health drugs. Figure 6 demonstrates the expected transition of top companies globally in the coming years.

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June 1-15, 2014

MANAGEMENT REPORTS

Growth foreseen at all levels of oral solid dosage form excipients market: Klien & Company Complex combination of factors are driving the market of speciality excipients for OSDF globally ON A global scale, the oral solid dosage form (OSDF) excipients market is growing sustainably, historically exhibiting a robust increase. This market is valued at nearly $2.3 billion in the US, Europe, India, and China, according to recently published Specialty Excipients for Oral Solid Dosage Form Pharmaceuticals Global Series: Business Analysis and Opportunities by worldwide consulting and research firm Kline & Company. In the emerging Indian and Chinese markets, growth in consumption of excipients is driven by rising incomes and willingness to spend more on healthcare. Key factors driving growth in major markets like the US and Europe include the ageing populations and high demand for pharmaceuticals. Nikola Matic, Industry Manager, Chemicals & Materials practice, Kline states, “Due to this growing demand, the major markets will continue to flourish; however, it is worth noting that emerging markets will outpace major markets.

36 EXPRESS PHARMA June 1-15, 2014

In the emerging Indian and Chinese markets, growth in consumption of excipients is driven by rising incomes and willingness to spend more on healthcare Driven by the Indian and Chinese markets, the consumption of OSDF excipients is expected to grow at a healthy pace of 7.4 per cent per year until 2018.” Although the major markets of Europe and the US have similar volume to the emerging markets of India and China, which currently stand at approximately 100,000 tonne per region, the market values are very different from one region to another. This is due to the different types of excipients used based on the

geography. While mature markets are dominated by functional and usually more expensive excipients, emerging markets are looking to use cheaper alternatives, such as native starches. “The added properties of some excipients allow more functional finished products, for instance, offering sustained-release of the active ingredient. Excipients vary greatly in price from $1.00 to $40.00 per kilo, and emerging markets are dominated by cheaper alternatives.

However, prices are not the only factor affecting the excipients market, as the consumption of OSDF excipients is driven by three different levels of drivers and restraints,” explains Matic. The consumption of excipients is primarily driven by the global growth of the pharmaceutical industry itself. This is the first of the three levels, and its key drivers include ageing populations in mature markets and economic growth in emerging markets. These macro drivers are continuing

to drive demand for the pharma. The second level consists of the factors affecting OSDFs in particular. For their easy use and manufacturing, OSDFs are favoured over other dosage forms, which again positively affect the market of OSDF excipients. The third level affecting growth consists of the trends shaping the OSDF excipients market internally. It notably includes the larger growth of excipients used in tablets due to the increased instances where tablets are preferred to capsules; Another example is the expansion of orally disintegrating tablets (ODTs),a successful sub-segment within OSDFs, which also benefit specific excipients. Finally, the growth of functional excipients which allow controlledrelease and sustained-release of active ingredients within a pharma product is also a micro-factor reshaping the consumption of excipients in both, mature and emerging market. It is important to understand how all levels interact to understand the current and future excipients market, notably as certain facts create important market opportunities. For instance, excipients such as povidone are seeing consumption increase significantly in some regions. The reason why these excipients are seeing increased consumption is due to the fact that they are enhancing the solubility of the actives, something troubling the industry for many years. EP News Bureau-Mumbai

MANAGEMENT

Breast cancer therapeutics market expands in Asia-Pacific: GBI Research Japan had the largest market in 2013 with a share of 58 per cent, followed by China and Australia, with respective shares of 21 per cent and 16 per cent THANKS TO an increasing uptake of branded drugs in AsiaPacific (APAC), the region’s breast cancer therapeutics market value will climb from $1.5 billion in 2013 to $2.5 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 7.6 per cent, forecasts business intelligence provider GBI Research. According to the company’s latest report, Japan had the largest market in 2013 with a share of 58 per cent, followed by China and Australia, with respective shares of 21 per cent and 16 per cent. Despite India having the lowest share in 2013, the country will witness the fastest growth over the forecast period, with a CAGR of 13.8 per cent.

Saurabh Sharma, analyst, GBI Research, says, “The use of targeted therapies is expected to increase in the APAC markets as patient access to these more expensive agents improves, aided by the entry of a biosimilar version of trastuzumab.” These targeted therapies will consist of novel and modified Human Epidermal growth factor Receptor (HER-2)-targeting agents, such as Perjeta and antibody drug conjugate Kadcyla, both from Roche, and novel chemotherapeutic agents from Eisai's Halaven. Others, such as Pfizer’s palbociclib and neratinib, and Boehringer Ingelheim’s afatinib, will also contribute.

Sharma continues, “The breast cancer pipeline is highly robust with potential drug candidates in various phases of clinical development. With more than 600 active pipeline molecules, the majority of the investigational drug candidates are being evaluated for the treatment of breast cancer in advanced stages, either as firstline or second-line therapies.” From a total of 612 active progressing pipeline molecules, 42 per cent are in the preclinical stage of development, 16 per cent are in phase I, 21 per cent are in phase II and eight per cent are in phase III, according to GBI Research. EP News Bureau-Mumbai

MDD therapeutics market to face dynamic phase up until 2023: Report GlobalData report also reveals that the MDD treatment market achieved a sales of approximately $9.3 billion in 2013 across seven major markets

THE THERAPEUTICS market for Major Depressive Disorder (MDD) will face a dynamic phase up until the end of 2023, thanks to the potential launch of new treatments following the patent expirations of top-selling products, says a new report from research and consulting firm GlobalData. According to the company’s latest report, the MDD treatment market achieved sales of approximately $9.3 billion in 2013 across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) and Australia. These sales will witness minimal growth by the end of 2023, reaching an estimated $9.7 billion, at a Compound Annual Growth Rate (CAGR) of 0.39 per cent. However, GlobalData forecasts that the market value will first undergo a decline until 2017, with sales dropping to $7.3 billion. This can be attributed mainly to the expirations of patents for Eli Lilly’s Cymbalta, Otsuka Pharmaceutical/BMS’ Abilify and AstraZeneca’s Seroquel XR. Toli Koutsokeras, Senior Analyst, GlobalData covering neurology, says, “Additionally, there are a number of significant needs in the depression therapeutics market that are yet to be addressed. These include the requirement for products that demonstrate improved efficacy, more favourable safety profiles and a rapid onset of antidepressant

effects. Ample opportunity therefore exists for players looking to develop and potentially introduce therapies, which can address these unmet needs, into this arena.” GlobalData states that there are already seven products in the late-stage pipeline that could enter the MDD market during the forecast period. These include adjunctive therapies, such as Otsuka/Lundbeck’s brexpiprazole, Forest (Actavis)/Gedeon Richter/Mitsubishi Tanabe Pharma’s cariprazine, Alkermes’s ALKS5461 and Naurex’s GLYX-13, along with antidepressant therapies, including Euthymics Bioscience’s amitifadine, Lundbeck/Takeda’s tedatioxetine and e-Therapeutics’ ETS6103. Koutsokeras continues: “All seven of these pipeline drugs show promise as safer and more efficacious treatments for MDD patients, while GLYX-13 and ETS6103 in particular boast the potential to provide rapid antidepressant effects.” “With their ability to address some of the MDD treatment market’s key unmet needs, we believe that these products’ launches could well spark its return to growth in 2018. Other driving factors behind the reversal in its decline will be the increasing uptake of Lundbeck / Takeda’s Brintellix, combined with the expanding number of MDD prevalent cases that we expect to see by the end of 2023.” EP News Bureau – Mumbai

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June 1-15, 2014

RESEARCH RESEARCH UPDATES

Failing animal research is delaying cures for Alzheimer’s disease: Study Research recommends utilising advanced technology based on human rather than non-human biology A DECADE of Alzheimer’s disease research dominated by artificially creating symptoms in genetically modified mice has failed to find a single cure that works in human patients, and could be delaying progress towards effective treatments, says a new paper published in Drug Discovery Today. The paper by Dr Gill Langley, senior science adviser to Humane Society International, calls for a fundamental paradigm shift in Alzheimer’s disease research utilising state-of-the-art techniques based on human rather than non-human biology. Next-generation tools such as functioning human brain cells in a test tube, neuroimaging and genomics must form the basis of a new framework for research that analyses the disease ‘pathways’ leading to Alzheimer’s, from the cell and tissue level to the whole body scenario. Dr Langley said, “Alzheimer’s is one of those disease research areas still very much dominated by the standard approach, studying the wrong condition in the wrong animal. The legacy of that approach is that despite a decade of effort using genetically modified mice, more than 300 potential treatments have been successful in animals but not a single one has proved effective in human patients. With one and a half million people in the UK alone projected to have Alzheimer’s in the next 40 years, continuing to focus on failing animal models is a waste of time

38 EXPRESS PHARMA June 1-15, 2014

and resources that is simply unsustainable.” “If we want to improve our chances of cracking this debilitating brain disease, we must embark on a new research roadmap that applies the very latest research tools to study the processes involved in the development of Alzheimer’s. From patient-derived human brain cells in culture, to powerful neuroimaging machines, and super-computers combining multiple data to reconstruct the disease pathways, Alzheimer’s can be mapped within the framework of human biology in order to understand why and how the illness occurs and how best to treat it. These advanced techniques will allow a complexity of understanding of this uniquely human disease never before achieved using animal models,” Langley said. A number of different

animal species have featured in Alzheimer’s research, including rabbits, dogs and monkeys. But for the last two decades, the dominant animal ‘model’ has been transgenic mice – mice with inserted faulty human genes that produce a few symptoms similar to the real disease. The problem is that the sum of a few artificially induced symptoms is not true Alzheimer’s, and so the condition developed in these mice differs from the human disease in how it is caused, how the disease progresses, and the sequence of symptoms that occur. Despite basic similarities in all mammalian brains, the different evolutionary paths of mice and humans mean that our brains differ in genetics, proteins, chemistry and physiology. One key example of this is a protein called apolipoprotein E. It is the only protein

US FDA seeks further evidence on efficacy of Novartis’ RLX030

proven to be a risk factor for common (late onset) Alzheimer’s disease, but it has a different structure and function in mice than in humans. Efforts to predict drug effects in patients based on memory tests in transgenic mice have also failed repeatedly, often because the results are very variable and difficult to interpret. A change in conceptual thinking and practice is long overdue. Focusing on human biology will eliminate problems of species differences, and patient-derived cells offer a true human disease model. Identifying underlying disease pathways and their key events will provide ‘targets’ for novel drug development, as well as demonstrating links between different illnesses such as Alzheimer’s and Parkinson’s disease.

NOVARTIS ANNOUNCED that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure (AHF), stating that further evidence on the efficacy of RLX030 is required for a US license to be granted. “We continue to believe RLX030 has the potential to be an important treatment for AHF and have been encouraged by feedback from FDA advisory committee members noting the data are intriguing,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “In accordance with the FDA's advice we will continue to expedite our clinical trial programme to build the supporting body of evidence.” The RLX030 submission to the FDA included phase II and III efficacy and safety data from the clinical development programme, including the pivotal phase III RELAX-AHF study. Novartis is continuing to expand the data supporting the efficacy of RLX030 in acute heart failure with an extensive global clinical programme, including the RELAX-AHF-2 trial which will enroll over 6,300 patients.

EP News Bureau-Mumbai

Drug therapy for allergy moves forward Traditionally, drug therapy for allergy is based on the use of non-sedative antihistamines RESEARCHERS HAVE identified several target molecules which are suitable for the development of new allergy drugs. The Journal of Allergy and Clinical Immunology, the journal in the field of allergology, has recently published an extensive review article on the prospects of drug therapy for allergy. Completed in a largescale EU project, the lead author of the review article is Professor Ilkka Harvima of the University of Eastern Finland and Kuopio University Hospital. It’s that time of the year again when people in many places of the world are struggling with allergies. Immediate allergic reactions and allergic diseases such as allergic rhinitis, asthma and urticaria are extremely widespread in the population. Traditionally, drug therapy for allergy is based on the use of non-sedative antihistamines, i.e. blocking of the histamine H1 receptors, but sometimes additional help is obtained from blockers of the cysteinyl leukotriene receptor1. Antihistamines seek to prevent allergic symptoms caused by histamine released by mast cells. Mast cells, also known as "allergy cells", are cells of the immune system which become activated by environmental al-

lergens. “However, even high doses of H1 antihistamine drugs aren’t enough to alleviate the symptoms of some patients. This is understandable, as when the mast cell becomes activated, several other strong mediators besides histamine get released, too. Histamine can also affect other receptors of the cell surface than the H1 receptor,” Professor Harvima explains.Over the past years, researchers have identified

several mast cell molecules which can be targets of new drugs. Several of these have already proceeded to clinical trials. These targets include, for example, serine proteinases tryptase, chymase, cathepsin G, which are enzymes that break down proteins, as well as 5-lipoxygenase-activating protein FLAP, 15-lipoxygenase-1, prostaglandin-D2, and proinflammatory cytokines such as TNF-alpha, IL-4, IL-6 and IL-17. New drugs targeting the

histamine H4 receptor are also undergoing clinical trials. In the near future, it is possible that drug therapy for allergy is a combination of H1 and H4 receptor blockers. Several target molecules have also been identified in intracellular signalling pathways and in cell survival proteins. Inhibiting these molecules can lead to the prevention of activation of the cell and to the prevention of mediator release. Various receptors which can either activate or inhibit the cell have been identified on cell surface. Different drug molecules make it possible to affect the function of these receptors and, consequently, to prevent cell activation and mediator release.The Mast Cells and Basophiles: Targets for Innovative Therapies project, funded by COST funding BM1007 of the EU, brings together European experts focusing on the identification of new target molecules for drug development, including allergy drugs. The University of Eastern Finland and Kuopio University Hospital were represented in the project by Professor Harvima, who is also the lead author of the review article.

trial. Patients receiving Isis's treatment also experienced lower rates of bleeding, the biotechnology company said. The reduced bleeding rate could offer an advantage over existing therapies, Deutsche Bank analysts said. The treatment was developed using Isis's "antisense" technology, which helps a compound bind to a specific gene to interrupt the production of disease-causing proteins.

ISIS-FXIRx targets Factor XI, a clotting factor produced in the liver. High levels of Factor XI raises the risk of thrombosis, a condition where abnormal blood clot formation could lead to heart attacks and strokes. The trial was evaluating 200 mg and 300 mg doses of Isis's treatment against enoxaparin in 300 patients. The smaller dose failed to show any significant benefit over enoxaparin.

London

"Due to the potential breadth of use as an anticoagulant, we expect Isis will partner this program within the next year," Deutsche Bank analysts said. Isis is developing 32 other drugs to treat a number of diseases. The company's cholesterol drug, Kynamro, is sold by partner Genzyme Corp, a unit of French drugmaker Sanofi.

RECKITT BENCKISER Group's pharmaceuticals unit plans to develop a nasal spray to treat overdoses of heroin and some prescription painkillers, the company said. Reckitt, better known for its Mucinex cold medicine and Durex condoms, said it had entered into an agreement with AntiOp to co-develop the spray, with the option to buy all rights to it upon receipt of regulatory and marketing approval. The deal diversifies Reckitt’s shrinking pharmaceuticals unit, which is currently the subject of a strategic review as it sits outside the company's core business in consumer products. This is the second such deal in less than a week and could help the company get a better valuation in a market flotation of the unit, which is what Reckitt has said it was leaning toward. Reckitt said last week it would develop a drug to treat alcohol abuse, in addition to its Suboxone treatment, which treats addiction to heroin and opioid painkillers such as morphine and oxycodone. Suboxone sales are falling due to competition from cheaper generic versions. When it comes to treating overdoses, the current standard medical protocol is an injection of the medicine naloxone. The new product aims to deliver naloxone in a nasal spray, which would be easier for family or caregivers to administer. Drug overdoses have surpassed car crashes to become the leading cause of injury death in the US, as use of opioids has increased steadily over the past decade.

Reuters

EP News Bureau-Mumbai

Isis Pharma’s blood thinner more effective ISIS PHARMACEUTICALS said its experimental blood thinner was more effective than a commonly prescribed anticoagulant in patients undergoing total knee replacement surgery. Isis said patients treated with a 300 mg dose of the drug, ISIS-FXIRx, experienced a significantly lower incidence of blood clots in their veins, compared with patients given the approved anticoagulant, enoxaparin, in a mid-stage

Reckitt Benckiser to develop drug overdose treatment

EXPRESS PHARMA

June 1-15, 2014

PHARMA ALLY I N T E R V I E W

I foresee huge growth in bioprocess sector The beginning of 2014 saw GE Healthcare Lifesciences acquire the HyClone range of Thermo Fisher Scientific for approximately $1.06 billion. Clearly, the company is looking at expanding its portfolio. Shalini Gupta finds out more in an interview with Anurag Gupta, Managing Director, Life Sciences, GE Healthcare, India

Tell us about the inception of GE Healthcare Lifesciences and the driving force behind it. GE has traditionally been in the healthcare space with its imaging systems, such as (CT, MRI, X Ray, Ultrasound). Our vision was to be an end to end provider in healthcare (from diagnosis to treatment) by also enabling pharma and biopharma companies to make vaccines, drugs and insulin. We wanted to enter into early health or early predictive health. Keeping this in mind we made our first acquisition â&#x20AC;&#x201D; Amersham, in the lifesciences space in 2004. Ever since we have done a whole lot of acquisitions in this space to make the whole domain more richer and better. These include Whatman, Xcellerex., PAA laboratories, API (Applied Precision), and most recently HyClone range of cell-culture business of Thermo Fisher. How has the product portfolio at GE developed over time? We have equipment and technologies for drug discovery and development and reagents. In the manufacturing space, we have products in the upstream process (bioreactors and cell culture media, fermentation) and downstream process (across multiple stages of purification). Before acquiring Amersham and even a few years after acquiring it, we were broadly in the purification space. 90 per cent of FDA approved biopharmaceuticals are made using GE approved downstream purification equipment or media. In the last

40 EXPRESS PHARMA June 1-15, 2014

few years, we decided not to confine ourselves only to downstream, but also look at upstream. We acquired Xcellerex in 2012 that helped us add disposable bioreactors to our portfolio, but still we did not have a definite presence in the upstream space. It was then that we started eyeing cell culture space, which explains our acquisition of HyClone, that matches well with our strategy of end-to-end in bioprocessing, our overarching goal. Tell us about your market share in India across various verticals within the company India is a promising market for biotechnology. GE Healthcare Lifesciences India has been growing at the rate of 35 per cent for the last three years in a row, which is almost twice the market growth. Broadly speaking, we have four verticals, Bioprocess (biomanufacturing), research (drug discovery and analytical equipment), consummables (includes Whatman), services (value added services like validation, IQ, OQ, PQ). Whatman alone is a business worth around ` 50 crores and with it we command 70 per cent of the filter paper market. In protein purification, our market share is 60 to 65 per cent. Research consummables is a crowded space and we'd like to be strong here. In analytical equipment specially in Biacore we are strong. Bulk of the equipment and consummables in life sciences follow the market growth except for Bioprocess which has been growing in an excess of 50 per cent for the past few years. In the research space,

Our philosophy, is to not just be a vendor, but an equipment supplier 60-65 per cent of the business comes from Indian government sponsored academic institutions and educational institutions whereas in bioprocess 95 per cent of it is driven by industry. What would you ascribe the growth in Bioprocess to? India is not a researchoriented market, and hence generics or biosimilars dominate as opposed to innovative drugs. With most of the biotech drugs reaching the end of their patent expiry date, a market worth upto eight billion dollars is up for grabs. All Indian companies are eyeing this market, and also trying to duplicate the same in

the biotech space. So even as patents expire, our customers are preparing themselves to enter that space. We are waiting for the biosimilars market to open up. It is a question of when will that happen. Healthcare costs in the US is horrendously high, with a huge pressure on the government to lower them, thereâ&#x20AC;&#x2122;s no doubt that in few years time, say by 2018, the US will open up the market. In the next 10-15 years, I foresee tremendous growth in the bioprocess sector due to this. What is your vision for the services division? Our philosophy, is to not just be a vendor, but an equipment supplier. I realised that the way to do business in the Indian market is to start partnering with the customer and help them with all the things that we know. Working with big MNCs, we have acquired a lot of expertise that we can pass on to Indian companies. Apart from the commercial team (which faces the customer in sales/service or applications), Fastrak, a global centre in Bangalore houses a dedicated lab with seven to eight scientists that focuses on customer education and training alongwith process development and process validation. We are the only company in this space with a team of upto 27 service engineers. How do Indian companies compare with their counterparts abroad? Are their needs and requirements different? Biotech is one space where

Indian companies are stronger than foreign companies in India. There aren't too many MNCs which are bigger than homegrown companies if we overlook recent acquisitions. They are bigger individually as well as collectively (forming 80 per cent of the total market) as well. This dynamic is hard to find in other industries. The market for these companies is overseas, so they need to exercise a high level of sophistication, technical expertise, quality control and follow US rules and regulations. Therefore their needs and requirements are no different than foreign companies. What are some of the products launched recently to meet customer needs? More and more customers are looking to invest in single use disposable systems rather than building huge stainless steel factories. While this shoots up the cost of consummables, the fixed cost is reduced drastically. The demand for our Xcellerex disposable bioreactors has gone up and the concept is catching up. It would take a few years for it to gain a level of acceptance and I foresee this as a trend going forward. To address affordability, we came out with AKTAStart, a lab purification system designed and developed in India, manufactured abroad. It is a table top model for entry level biotech customers such as universities, educational institutions and first time primary investigators that costs ` 5-6 lakhs. shalini.g@expressindia.com

VENDOR NEWS

Mankind Pharma to adopt SoftLayer’s cloud platform The SoftLayer infrastructure is expected to help Mankind Pharma scale up quickly when it expands operations to international markets IBM ANNOUNCED that Mankind Pharma has selected SoftLayer’s cloud platform to support its business growth and expansion. SoftLayer, an IBM company, will enable Mankind Pharma to significantly improve the performance of its business critical applications and scale the use of these applications across multiple locations. SoftLayer’s infrastructure was chosen as the ideal solution to fit the business needs of Mankind Pharma. It ensured scalability of the infrastructure depending on Mankind Pharma’s changing business needs. Since these business critical applications are

SoftLayer’s infrastructure was chosen as the ideal solution to fit the business needs of Mankind Pharma. It ensured scalability of the infrastructure depending on Mankind Pharma’s changing business needs designed to meet the growing needs of its key stakeholders, it becomes mission-critical for Mankind Pharma to deploy the right amount of compute to run

seamless operations. SoftLayer cloud provided the perfect combination of pay-as-you-use option as well as scalability to suit business need.

“We chose SoftLayer as a service which helped us deploy our business critical application on Cloud which required a highly scalable infrastructure to meet the ongoing demands of the market. SoftLayer is geared to meet these requirements and help us continue our strong business momentum and provide greater client satisfaction,” said Pramod Gokhale, Vice President-Information Services & Strategy, Mankind Pharma. Apart from scaling operations during peak months, the SoftLayer infrastructure will also help Mankind Pharma scale up quickly when it expands operations to

international markets. “IBM has been a strategic partner of Mankind Pharma for a long time and it is exciting to see our engagement is expanding on to cloud. With SoftLayer, IBM is focused on providing higher value and delivering unmatched expertise and capabilities to help clients tackle business specific challenges with cloud. With SoftLayer cloud, Mankind Pharma can have a better control on their operations to drive business growth,” said Ganesh Margabandhu, General Manager, Global Technology Services, IBM India South Asia. EP News Bureau - Mumbai

Takeda Pharmaceuticals partners with Wipro The strategic partnership aims to build advanced value in Takeda’s operations by consolidating IT platforms across the organisation WIPRO ANNOUNCED a strategic partnership with Japan-based Takeda Pharmaceutical Company, the largest pharmaceutical company in Japan and one of the global leaders of the industry. The strategic partnership will build advanced value in Takeda's operations by consolidating IT platforms across the organisation. As a strategic partner, Wipro will build and maintain an 'as-a-service' global platform for Takeda

that will drive synergies across its global entities through standardisation of IT architecture. Wipro will be primary provider of IT Infrastructure management services covering Takeda’s entities across the world, touching 30,000 users in 16 different languages, operating out of data centres in Asia, Europe and America. Sangita Singh, Chief Executive - Healthcare and Life Science Business Unit, Wipro

Wipro will drive Takeda’s IT infrastructure, consolidating and optimising resources across the organisation

said, “We are thrilled to partner with Takeda in its business transformation journey. Wipro is leveraging its experience in enabling global pharma companies to achieve a leaner and standardised IT workplace and implement newer business models that put patient at the core. We look forward to collaboratively partnering with the Takeda team in enabling this unique platform across its global operations.”

“Wipro will deliver the ‘as-aservice’ on demand model, which is redefining the way organisations purchase technology. With our global delivery capabilities, Wipro will drive Takeda’s IT infrastructure, consolidating and optimising resources across the organisation,” added GK Prasanna, Chief Executive - Global Infrastructure Services and Product Engineering Services, Wipro. EP News Bureau – Mumbai

EXPRESS PHARMA

June 1-15, 2014

PHARMA ALLY

IGBC LEED-India’s gold rating for ACG factory The company’s Pithampura factory is the first one to receive it in the pharma industry INDIAN GREEN Building Council (IGBC) LEED-India has awarded its gold rating to ACG’s new state-of-the-art capsule manufacturing plant in Pithampur, making it the first factory in Indian pharma industry to receive this rating. The Leadership in Energy and Environmental Design (LEED-INDIA) Green Building Rating System is a nationally and internationally accepted benchmark for the design, construction and operation of high performance green buildings. ACG’s Pithampur factory incorporated green features right during the design and layout stages. From providing sockets for charging electric vehicles in parking spaces to including energy-efficient lighting fixtures; from automated water efficient fixtures to an onsite ETP plant for 100 per cent water treatment; from highly-efficient HVAC systems to CFC-free refrigerants and fire suspension systems; from using Forest

ACG EUROPE LISTED IN ‘TOP 41 FASTEST-GROWING INDIAN COMPANIES’IN THE UK ACG WORLDWIDE’S UK subsidiary ACG Europe has been listed in the UK’s ‘Top 41 Fastest-Growing Indian Companies.’ACG Europe features within the top 25 fast-growing Indian-owned companies.The list, developed by the UK’s leading auditing and management consultancy firm Grant Thornton in conjunction with Confederation of Indian Industry (CII), identifies fast-growing Indian companies in the UK by turnover, sector and employee strength. The research report,‘India Meets Britain: Tracking the UK’s Top Indian Companies,’adds that there are more than 700 Indian-owned businesses in the UK. Of this, the 41 fast-growing companies contributed nearly £19 billion in turnover, achieving growth rates of over 10 per cent. Few companies, including ACG Europe, even achieved more than 20 per cent - outstripping the UK’s existing GDP growth rate. The fastest-growing Indian companies are spread across the UK, with just 29 per cent of the Top 41 based in London.Also headquartered in the capital,ACG Europe offers end-to-end pharma

processing, manufacturing and packaging solutions to pharmaceutical and nutraceutical companies in the UK and Europe.The research adds that nearly half are in the pharmaceuticals and chemicals (22 per cent) and technology and telecoms (32 per cent) sectors. “This is quite an achievement for ACG.We are pleased to be a part of a list of companies that continue to make a difference to the total economy wherever they are,”said Ajit Singh, Chairman,ACG Worldwide. He added,“From ACG’s perspective, the UK remains a strong and matured market with attractive possibilities to invest and gain a strong foothold in the European market.After ACG’s establishment in the UK, we later expanded our base in Europe with an acquisition in Croatia. Our commitment to growth in the UK and European region is long term and has today helped us continue our growth in serving the global pharma industry.”

EP News Bureau- Mumbai

Stewardship Council (FSC) certified wood to recycling or reusing 95 per cent of construction waste; from improving indoor air quality as per American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) standards to using low VOC content paints, sealants and adhesives - every bit of care and precaution has been exercised while executing the project. Selwyn Norohna, Chief Executive Officer, ACG Associated Capsules’ said, “ACG has always been steadfast in its social responsibilities, be it health and education related initiatives or our long-standing environmental commitment. A Gold rating from esteemed and internationally recognised organisations such as IGBC and LEED acknowledges our efforts to build a sustainable future - not just for ourselves, but for our future generations as well.” EP News Bureau - Mumbai

Waters launches CORTECS 2.7 micron columns New columns reportedly help maximise HPLC separation efficiency and throughput WATERS CORPORATION has expanded its family of CORTECS Columns with the introduction of a new line of 2.7 micron silica-based, solid-core particle columns that set a new standard for HPLC column performance. The new set of columns is the newest addition to the Waters CORTECS family of columns. Waters introduced the first – a set of 1.6 micron solid-core particle columns –in 2013. Designed for analytical scientists who need to maximise performance on their existing LC systems, CORTECS 2.7 micron columns run at lower

42 EXPRESS PHARMA June 1-15, 2014

pressures while delivering high efficiencies. This gives the scientist the flexibility to use longer column lengths to improve resolution or higher flow rates to speed instrument analysis times and increase throughput. Available in C18+, C18, and HILIC chemistries, Waters offers the columns in 48 unique column configurations and is making them immediately available for shipping worldwide. “Waters now gives chromatographic laboratories the ability to improve the resolution, speed, and sensitivity of their HPLC separations,” said

Waters offers the columns in 48 unique column configurations and is making them immediately available for shipping worldwide

Michael Yelle, Vice President, Consumables Business Unit, Waters Division. “The advanced solid-core particle design of CORTECS 2.7 micron columns together

with Waters’ 40+ years of column manufacturing expertise put these columns at the head of their class in terms of overall chromatographic performance with the market leading

batch-to-batch reproducibility, robustness and quality our customers have come to expect from Waters.” The new columns complement Waters CORTECS 1.6 micron Columns for UltraPerformance LC (UPLC) introduced in 2013. CORTECS 2.7 micron Columns are fully scalable to CORTECS 1.6 micron Columns, thus allowing separation scientists who currently run HPLC separations the ability to future-proof their laboratories and seamlessly transfer or migrate their separation to UPLC. EP News Bureau – Mumbai

PHARMA ALLY

Aptar Pharma hosts expert panel round table on ‘Inhaler Adherence’ Objectives were exploring key factors leading to inhaler device non-adherence/ non-compliance, identifying unmet needs and potential opportunities for improvement APTAR PHARMA recently hosted an expert panel roundtable on ‘Inhaler Adherence.’ The roundtable was organised to explore and exchange views on the issues which may influence inhaler adherence/compliance with a particular focus on asthma and COPD therapies and their corresponding inhaler devices (MDIs, DPIs). The overall objective of the meeting were to explore the key factors that lead to inhaler device non-adherence/non-compliance, identify some of the unmet needs, and identify potential opportunities for improvements in inhaler adherence. Participants who took part in the meeting were Chris Baron, Assistant Director, Business Development, Aptar Pharma Prescription Division, France; Beverley Bostock, Nurse Practitioner, Clinical Lead, Warwickshire, UK; Guillaume Brouet, President GMD, Aptar Pharma Prescription Division, France; Dr Nayna Govind, NG Pharma Consulting Ltd, UK; Dr Kevin GruffyddJones, GP, RCGP Respiratory Clinical Lead, Wiltshire, UK; Christine Loveridge, Respiratory Clinical Lead, Education for Health, UK; Professor Nicolas Roche, Head of Pulmonary Service, Central Paris University Hospital, France; Dr Gerallt Williams, Director, Scientific Affairs, Aptar Pharma Prescription Division, France. During the one-day meeting, which focused on inhaler adherence, the key opinion leaders shared their knowledge and debated a number of topics, including: Current guidance with regard to therapy/inhaler prescribing; Specific healthcare professional and patient issues with inhaler devices and unmet

KEY THOUGHTS FROM KEY OPINION LEADERS ● Asthma and chronic obstructive pulmonary disease (COPD) are common chronic inflammatory diseases, and can significantly interfere with a patient’s quality of life. The major symptoms of these diseases are wheezing, coughing, chest tightness and shortness of breath. ● It is estimated by the World Health Organization (WHO)

needs; Potential avenues for making more adherencefriendly inhalers; Healthcare costs, reimbursement and emerging therapies. Recent figures show that over 90 per cent of the devices used worldwide by sales volume (and over 70 per cent by sales value) for the treatment of asthma and COPD are pressurised metered dose inhalers (pMDIs) or dry powder inhalers (DPIs). It has been estimated

that some 300 million people worldwide suffer from asthma, and 240 million people suffer from COPD. The cost of these diseases to the US healthcare system is estimated at $50 billion for asthma, and $32 billion for COPD. ● Lately, the asthma and COPD market has grown significantly in the emerging markets of Brazil, China, India and Russia.

that non-compliance with the prescription can reach 50 per cent in patients suffering from asthma. Studies specifically on pMDIs show that misuse of these devices is seen in 50 per cent of cases. The result of this non-compliance is poor disease control and elevated healthcare costs. Participants looked at the process of prescribing inhalers for the treatment of asthma and COPD, which was seen to be a

complex issue. Although detailed industry guidance exists to help select the correct therapeutic class of drug, there are a number of factors related to the patient’s capabilities that must also be considered. These include age, coordination skills, inhalation capacity and patient preferences. Selecting the actual device type depends on the therapeutic class of drug, the cost, and whether to use innovator or generic products. The participants noted that the selection of the inhaler device type is at least as important as the type of therapy chosen. The participants then discussed what happens once the inhaler is selected. When a patient consults a physician about a new inhaler, it is unlikely that much time can be spent on instructions for use. Consulting a respiratory nurse practitioner for instructions for use is seen as best practice, with follow-up sessions to check on correct use. The diversity of inhaler devices on the market is also seen as a challenge. This is perceived as a specific issue for DPIs, which may have very different modes of operation, with some patients having separate inhalers for asthma relief and asthma control, each providing a different patient experience. Looking to the future, the participants saw promise for better adherence in active monitoring and feedback, using smart devices. A new generation of e-devices will be potentially able to communicate with future tele-health systems. In a study in the UK, reminders and incentives to use the inhaler proved capable of reducing costs by over 20 per cent and emergency admissions to hospital by 50 per cent.

Participants noted that healthcare providers and pharmaceutical companies may need to collaborate on the issue of reconciling the ‘increased costs’ associated with developing more patient adherent devices and products with the target of reducing overall health care costs. “It was agreed by all the participants in this round table that inhaler non-adherence is a real issue in asthma and COPD therapy. Discussions identified a number of issues that impact non-adherence and looked at ways of addressing these issues, in both the short and long term,” said Chris Baron, Associate Director, Business Development, Aptar Pharma Prescription Division. He concluded by saying, “Aptar Pharma is pleased to have once again provided the platform for such a productive and industryrelevant roundtable.” Several issues were identified as having an impact on patient inhaler adherence, ranging from lack of time to train or instruct the patients all the way to there being too many different types of inhalers already available in the market place. Training and follow-up are obvious avenues for improving inhaler adherence and several add-on features would be welcome on inhaler devices. Looking into the future the role of monitoring and feedback could also play a role in improving adherence. Finally, cost is becoming a major influence on how inhalers are prescribed and ultimately on inhaler adherence, very much tied in with the ever-increasing healthcare cost burden worldwide. EP News Bureau - Mumbai

EXPRESS PHARMA

June 1-15, 2014

PHARMA ALLY PRODUCTS

SOLAμ SPE plates from Thermo Fisher A TREND in bioanalysis is moving toward methods that require higher levels of sensitivity and reproducibility with decreasing sample volumes. To meet these needs, Thermo Fisher Scientific has introduced Thermo Scientific SOLAμ solid phase extraction (SPE) micro elution plates. Using award-winning SOLA SPE technology, SOLAμ plates are designed to deliver robust, reproducible processing at elution volumes as low as 25 μL. In company-conducted experiments, the new SPE plates have improved sensitivity over comparable SPE products as much as twenty-fold due to improved pre-concentration while maintaining high levels of reproducibility. The SOLA macro-porous structure is designed for robust, reproducible results with

(mixed-mode strong anion exchange), SOLAμ WCX (mixed-mode weak cation exchange) and SOLAμ WAX (mixed-mode weak anion exchange) stationary phases. Using a proprietary design and manufacturing technique, SOLAμ plates combine polyethylene frit materials and stationary phase materials into a uniform stationary phase. This mitigates problems caused by voiding, channelling and packing inconsistencies, which can cause variability in results. The design enhances reproducibility, well to well, plate to plate and batch to batch. consistent sample and solvent flow through the SPE stationary phase, which can mitigate blockages caused by viscous biological samples. The low elution volumes accommodated by SOLAμ

plates can provide a more efficient workflow by removing the blow-down stage of the SPE process. It offers the added benefit of more stability for molecules that are susceptible to adsorption and solvation

issues. SOLAμ SPE products are available in 96-well-plate format and include: SOLAμ HRP (reverse phase), SOLAμ SCX (mixed-mode strong cation exchange), SOLAμ SAX

Contact details Media Contact Information: Stu Matlow San Jose, Calif., USA Phone: +1 408-965-6408 stu.matlow@thermofisher.com

Cole-Parmer launches hydrogen gas generators COLE-PARMER has launched Paker Balston’s hydrogen gas generators. Proven in over 40,000 GC installations worldwide, these generators are compact and reliable, only one square foot of bench space required. Its unique display lighting changes colour for easy status checks and water level indication. Its exclusive water management system and control circuitry maximise uptime. Parker Balston’s Proton Exchange Membrane (PEM) Cell eliminates the use of liquid electrolytes with hydrogen generators. The maintenance of the equipment requires only a few moments per year at no inconvenience and extended downtime. At a very nominal cost, the filters need to be changed every six

44 EXPRESS PHARMA June 1-15, 2014

months and the desiccant cartridge whenever it turns dark brown. De-ionized water is all that is required to generate hydrogen for weeks of continuous operation. With an output capacity of up to 510 cc/minute, one generator can supply 99.9995 per cent pure hydrogen for up to several FID’s. Based on cylinder gas savings alone, a Parker Balston hydrogen generator pays for itself in less than a year. All Parker Balston hydrogen generators meet NFPA requirements and OSHA 1910.103 regulations governing the storage of hydrogen. Many labs are turning to gas generators for convenience. When selecting the proper carrier gas for gas chromatography, a laboratory manager traditionally has

three choices: nitrogen, helium or hydrogen. Global supply issues related to helium and sometimes other gases have led to shortages and significant price increases in both gas costs and cylinder fees. As a result, many laboratories are re-evaluating the best carrier gas to provide maximum analysis time while offering safety and cost effectiveness. Reasons labs are considering purchasing a gas generator include: increased safety, cost savings (cheaper than gas cylinders), switching helium to hydrogen, upgrading old systems, quality control, and so on. Contact details Tel: 022-67162229/53 e-mail response@ coleparmer.in website: www.coleparmer.in.

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BUSINESS AVENUES

June 1-15, 2014

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BUSINESS AVENUES

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Quality Through Experience By Erweka India

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PHARMA LIFE I N T E R V I E W

‘The need of the hour is to change the mind-set of professionals’ Indian Pharmaceutical Association (IPA) is celebrating its platinum jubilee year and the appointment of Rao VSV Vadlamudi, as its President, IPA and Director. In an interaction with Usha Sharma, Vadlamudi discloses details about his added responsibilities that comes with his current position, outlines areas which require immediate attention from pharma companies and the regulatory fraternity, and his agenda for the upliftment of pharmacy professionals You have been elected as the President of IPA at a time when the association is celebrating its platinum jubilee year. How challenging will your role be? Firstly, I am very fortunate to get elected as the President of the Association when it is in its 75th year. The role is indeed very challenging since all members and pharma professionals are eagerly waiting to see what is likely to unfold during the platinum jubilee year. There are various challenges, both internally as well as externally. Internally, we need to put in place best practices for proper governance while externally, we need to be more visible through our five divisions, the industrial pharmacy, the regulatory affairs, the community pharmacy, the hospital pharmacy and the education. This is a mammoth task, however, I am highly confident that with the new committed and vibrant team in place, we will be able to accomplish our objectives. What is your agenda and how do you plan to accomplish it? We do have an agenda, which was developed in discussion with the new team of office bearers. The agenda briefly touches on the following major issues:

62 EXPRESS PHARMA June 1-15, 2014

■ To activate all IPA state

■ To create a highly active

and local branches through activities planned during the platinum jubilee year with the support from IPA Centre to impart a sense of belonging to all members and to enroll more members. ■ IPA secretariat to ensure smooth and rapid communication with all branches and members by making IPA website dynamic and interactive. ■ To ensure that all divisions of IPA become active during the platinum jubilee and to further promote activities of the highly active divisions like community pharmacy to different parts of the country. ■ To define and promote the role of pharmacy graduates with diploma, bachelors, masters and Pharm. D. degrees in National Health Care programmes and work towards creation of employment opportunities for pharmacy fresh graduates. ■ To develop ‘Focus Groups’ in IPA to strengthen the role of IPA in various platforms at national and international level. ■ To represent in governmental bodies and committees to play a pivotal role in developing regulatory policies for the pharmacy profession on all fronts, Industry, education, regulatory and pharmacy practice

publication platform to efficiently manage IPA publications such as Pharma Times, Indian Journal of Pharmaceutical Sciences, IPACPD e-Times and Panache live to create an international image for IPA and enhance readership. ■ To ensure that IPA is a preferred partner for all professional organisations within the country and outside to organise professional activities.

others to pharmacy research and teaching, pharmacy practice and so on. The advantage of such grouping would be that interaction between the industry and possible other employers and institutions can be enhanced in a structured way. IPA education division will look in to this direction. A part of this strategy would be to involve industry experts to design training programmes for students and to have regular interaction with the Industry.

In the last few years, it has been observed that the visibility of pharma institutions and companies' associations have faded. What is your say on this? What will be your immediate actions? There has been a phenomenal increase in the number of pharmacy institutions as well as in the number of students graduating each year, without a concomitant increase in the standard of curriculum and its delivery. The need of the hour is to prepare students of tomorrow who can meet the challenges faced by the country in terms of providing better healthcare. There is a need to categorise our pharmacy institutions in such a way that some provide better employable resources to pharma industry, while

Since 2013, the pharma industry is observing various changes/reforms, which have impacted it negatively. What reforms would you like to put forward to the Ministry and why? Of late, scrutiny by global regulators in their routine inspection of facilities has reached to such a level that several quality issues are repeatedly surfacing. This calls for creating an atmosphere in which constant interaction between the regulator and the manufacturer is to be fostered to create faith and commitment to quality. IPA has been in continuous dialogue with regulatory bodies to create such an environment. Discussions are in final stages with UK Medicines and Healthcare

The need of the hour is to prepare students of tomorrow who can meet the challenges faced by the country in terms of providing better healthcare

Products Regulatory Agency (MHRA) for initiating training and development, which focus on important areas of interest to industry. IPA already has good relations with European Directorate for the Quality of Medicines (EDQM) and regularly organises training programmes every year. The need of the hour is to change the mind-set of professionals and to create a culture of quality in every aspect of operations. When that is achieved India will certainly maintain its prime position in global market. According to you, what are the top five issues which are hampering the growth of pharma industry in India and who are actually responsible for it? ■ Affordability and patientcentric focus ■ Improvement in governance and regulatory mechanisms ■ Lack of resources to go all out for innovation ■ Less budget allocation for research and healthcare sector ■ Availability of skilled manpower It is very difficult to pinpoint who are responsible for the lack of growth, or better to state slow-down of growth. All stakeholders are collectively responsible and it is difficult to point fingers at some one. For example, government policy makers and regulators’ ability to visualise our country’s

healthcare scenario, pharma manufacturers and their quality mind-set, pharma professionals and their willingness to learn and change, pharma educators and their knowledge of current global requirements, professional organisations and their efforts to bring about a change in all stakeholders, graduating pharmacy students and their motivation and drive to learn and lead, are all in one way or other responsible for the current situation that we are in.

The need of the hour is to change the mind-set of professionals and to create a culture of quality in every aspect of operations. When that is achieved India will certainly maintain its prime position in global market

In 2015, Indian Pharmaceutical Association Student Forum (IPASF) will host the International Pharmaceutical Student Federation in India. How will this event help to encourage Indian students in enhancing their capabilities, knowledge and reward them in the long term? International Pharmaceutical Student Federation (IPSF), though has been in existence since the last 60 years, was not very popular among Indian students all these years. Indian pharmacy students under the mentorship of IPA Education division established the IPA-Students Forum (IPASF) about five years ago and became a member of IPSF. In these five years, IPA-SF made a huge impact; firstly they won the ‘Best Student Forum in the World’ award last year and successfully bid for the 61st

IPSF World Congress 2015 to be held first time in India, indicating the recognition by global community of students. Through the association with IPSF and participating in the world congress, the Indian pharmacy students will gain skill sets such as strong networking, understanding global scenarios, opportunities for career enhancement, leadership training and development of organisational skills. They will also understand the importance of having a constitution, value of strong internal democracy and planned way in which organisations can run. All these would help our students build a very strong IPA-SF. Participation in the world congress would help students learn how to voice their opinion to the right people to get the much-required exposure. Through this world

congress our country and our culture would get better exposure leading to a stronger relationship between IPSF and IPA-SF, which would open doors for our students to WHO and UN through IPSF. How is the pharma industry's slated to grow in next five years? Clinical sector will come back to limelight with establishment of strong regulatory standards meeting global norms; more and more consolidation will be seen in pharma sector creating a chance for contract research to grow. India will take a strong leadership position among emerging countries. The focus will shift to protein therapeutics and biosimilars. innovative research will be more oriented towards niche areas of unmet medical needs and orphan diseases.

Tell us about your mission and vision for uplifting the Indian pharma industry. IPA mission statement is as follows “The Indian Pharmaceutical Association is the national body of pharmacy professionals engaged in various facets of the profession of pharmacy. IPA is committed to promote the highest professional and ethical standards of pharmacy, project the image of pharmacist as a competent healthcare professional, sensitise the community and government and others on vital professional issues and support pharma education and sciences in all aspects.” From the mission statement it is very clear that IPA has a very broad agenda, of which industry is an integral part. IPA would like to make all efforts to bring about a cultural change in the industry that would promote quality awareness in every aspect and develop a patientcentric focus. IPA would like to work towards developing the future pharmacists fully equipped with knowledge about current and future requirements through constant interactions with all stakeholders. IPA envisages its role in the development of community and hospital pharmacists, which would play a major role in creating a better health care system in our country. u.sharma@expressindia.com

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June 1-15, 2014

PHARMA LIFE INSIGHT

Astudy on field force attrition and the response of consulting doctors in Greater Mumbai Dr Savita Chari, Senior Research Associate, School of Business Management, SVKM’s NMIMS (Deemed-to-be-University) and Dr Tarun Gupta, Professor Emeritus at the School of Business Management and Chairman, MBA – Pharmaceutical Management, SVKM’s NMIMS (Deemed-to-be-University) explores how consulting doctors in Greater Mumbai react to the high rate of attrition among medical representatives

FIELD FORCE attrition refers to medical representatives leaving one drug company within a period of less than a year and joining another drug company. Sometimes medical representatives leave the pharmaceutical industry and take jobs in BPOs, insurance companies, etc. The present attrition year rate in a pharma company is calculated around 25–30 per cent. This effectively, means that a company has to recruit, select and train an entirely new field force every four years or so. This is considered to be a very high cost replacement activity for drug companies which most of the companies find unacceptable.

DR SAVITA CHARI, Senior Research Associate, School of Business Management, SVKM’s NMIMS (Deemed-to-be-University)

DR TARUN GUPTA, Professor Emeritus at the School of Business Management and Chairman, MBA – Pharmaceutical Management, SVKM’s NMIMS (Deemed-to-be-University)

EXHIBIT 1: HOW DO YOU FEEL ABOUT ATTRITION IN DRUG COMPANIES? Q No.

Responses of consultant doctors

Count

Does not matter to me when the medical representative change the company

22.3

Doctors feel nothing when the medical representative changes the company

Consulting doctors go by the product they prescribe

8.4

Doctors “feel”unpleasant

7.7

Doctors feel it is a common trend today

7.3

Consultants “feel”it a medical representative’s personal choice

198

4.3

Doctors said that they enquire about the reason for the change of job

3.1

Medical representative leave for better opportunity

2.7

Doctors get confused / surprised when the medical representative leave one company and join another company

2.5

Doctors opinion depends in the quality of the medical representative who leaves a company

2.5

Doctors prescriptions habit does not change

1.3

Consulting doctors response, depends in the company and its products and not on the medical representative

1.3

Objectives of the study Apart from the cost aspect of such attrition, it is important to explore how doctors in Greater Mumbai react to such attrition. This study, for the first time, explores how consulting doctors in Greater Mumbai react to this high rate of attrition among medical representatives. In this study, consulting doctors were directly asked: How they ‘feel’ about field force attrition and what do they have to recommend for drug companies as remedial

64 EXPRESS PHARMA June 1-15, 2014

Total

measures to retain medical representatives?

The study A total of 438 consulting physicians were individually interviewed for the purpose of this study. The consulting doctors were asked: How do you feel about field force attrition in drug companies today?

81.4

The responses are tabulated as follows Most doctors indicated that they do not ‘feel’ anything when a medical representative leaves a company. When asked as to what a company should do to reduce attrition, they said It would appear from their responses that consulting doctors in Greater Mumbai put the

blame squarely on drug companies and their practices. The respondents were not aware of how many from the field force leave companies every year. They knew it was high, but they felt companies are solely responsible for this attrition. (See Exhibit II) If we had not probed further, we would not have understood

the responses of consulting doctors. Is it true then that consultants don’t ‘feel’ anything when medical representatives leave a company? Many doctors informed that they ‘feel’ nothing when a medical representatives changes from one company to another. When we delved deeper, we found that except for some

PHARMA LIFE consultants most felt that the company was responsible for this attrition. When asked as to what remedial action the companies should take doctors said the following. (See ExhibitIV) .

Conclusion ◗ One needs to understand that

doctors have very ‘strong views’ on what action should drug companies take on attrition. ◗ Some replies clearly show that medical representatives share their problems with consulting physician when they leave a company. ◗ It would be wrong to assume that consulting doctors don’t usually care about the attrition rate of medical representatives. ◗ From the remedies suggested by doctors it appears quite clearly that majority of consultants believe that companies are mainly responsible for the high attrition rate among medical representatives. ◗ Consultants obviously know much more than what was evident when we asked how do you, feel about the attrition among medical representatives. ◗ The significant point is that medical representatives do ‘talk to consulting doctors,’ when they change jobs and much of the blame is put on the companies. ◗ That is why consulting doctors have, said ‘increase salary of medical representatives reduce work pressure, provide harmony, provide extra incentives, etc.’ ◗ It is evident that medical representatives talk to (Consulting doctors) and it is possible that this practice continues because the companies don’t seem to be ‘listening’ to the medical representatives at all. ◗ All companies need to ‘listen’ to their own field people so that their frustration need not spill over to customers. Exit interviews are a must.

References (Bibliography):1. Dey, S., (June 2006), Controlling Attrition. Ref.:editorial@pharmaonline.com URL: http://pharma.financialexpress.com/20060615/pharmalife01.shtml 2. Dhotre, A., (August 2010), At-

trition in Pharmaceutical Industry: Human Resource Management’s Role and Strategy. International Research Journal. URL: http://ir.inflibnet.ac.in: 8080 /jspui/bIt’stream /10603/10199/8/08_chapter%201.pdf

EXHIBIT II: WHAT ACTION COMPANY SHOULD TAKE TO REDUCE ATTRITION? Q No

Response from consulting doctors

Count

Increase salary

131

36.6

Reduce work pressure

19.3

Provide training

17.9

Provide extra incentives

5.8

Provide promotion to medical representative

5.6

Increase salary and incentives

4.2

Increase salary and provide training

4.2

Reduce targets

3.9

Give timely rewards

1.6

Provide better incentive and training

1.1

Total

Q NO

3. Gupta, A. & et. Al., (October 2009), Mastering sales force integration in a merger. McKinsey & Company. URL: http://www.mckinsey.com /insights/marketing_sales_force_integration_in_a_merger 4. Miller, G., (May 17, 2011), PWC Reports high Pay, Attrition at Indian Pharmas. Ref.: Fierce Pharma Manufacturing. URL: http://www.fiercepharmamanufacturing.com/story/pwcreports-high-pay-attrition-indian-pharmas/2011-05-17

100.2

EXHIBIT III: LISTENING DEEPER - WHAT DOCTORS SAID?

COUNT

Q No

Response from consulting doctors

Count

We feel nothing

14.2

No comments

4.7

I don’t feel anything, they keep changing

0.9

No feelings as it is the medical representative and company matter

0.9

I don’t feel anything as it is a medical representative’s job

0.4

I don’t analyse it too much

0.2

Why should I feel anything, it does not impact me

0.2

Total

21.5

EXHIBIT IV: DOCTORS RECOMMENDATION TO DRUG COMPANIES TO REDUCE ATTRITION RATE

COUNT

Response from consulting doctors

Count

We believe that company should take more care of medical representative

359

81.9

Company should not take more care of medical representative

17.5

Did not answer

0.45

Total

99.85

5. Sharda, K., (July 2012), Managing Talent at Lupin Limited. Vikalpa, Indian Institute of Management. URL: http://www.vikalpa.com/ article/article_detail.php?aid=943 6. Sharma, J. and Rajesh Davidson. OVERVIEW ON: ATTRITION IN PHARMACEUTICAL MARKETING, CAUSES AND IT’S MEASURES. Reference Id: PHARMATUTOR- ART-1392 URL: http://www.pharmatutor. org/articles/overview-attritionpharmaceutical-marketingcauses-measures 7. Sharma, U., (Friday, 30th March, 2012), Talent hunt: The race intensifies. Express Pharma. URL: http://pharma.financialexpress.com/sections/pharma-life2/340-talent-hunt-the-race-intensifies 8. Smarta, Dr. R.B., (2012-13), Restoring professional pride to medical selling. Interlink Insight, vol. 11 Issue 1. 9. Mar 11, 2013. Turn-over of sales force and their specific ways of strategies in the Indian pharma industry. Articlebase. URL: http://www.articlebase.com/ human-resoruces-articles/ turn-over-of-sales-force-andtheir-specific-ways-of-retentionstrategies-in-the-indianpharma-industry-6497645.html

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PHARMA LIFE AWARDS

Kiran Mazumdar Shaw receives coveted ‘Othmer Gold Medal 2014’ She gets the award for pioneering efforts in biotechnology and for scripting an entrepreneurial story by drawing on her knowledge of fermentation science to build Biocon KIRAN MAZUMDAR SHAW, Chairperson and Managing Director, Biocon received the ‘Othmer Gold Medal 2014’ in Philadelphia, Pennsylvania, US. Established by the Chemical Heritage Foundation (CHF) in 1997, the annual award honours outstanding individuals who have made multifaceted contributions to chemical and scientific heritage through outstanding activity in such areas as innovation, entrepreneurship, research, education, public understanding, legislation or philanthropy. Shaw is the third woman to receive the Othmer Gold Medal and the first Indian to make it to this prestigious group. Carsten Reinhardt, President and Chief Executive Officer, CHF, handed over the Foundation’s top award

(L-R) Kiran Mazumdar Shaw and Carsten Reinhardt

to Shaw during CHF’s Chemical Heritage Day celebration that culminated with

the presentation of the Othmer Gold Medal. The CHF lauded Shaw’s pioneering efforts in

biotechnology and for scripting a hugely successful entrepreneurial story by drawing on

her knowledge of fermentation science to build Biocon. Shaw said, “I am grateful to the CHF for awarding me the Othmer Gold Medal 2014. This is an honour akin to being invited to join an extraordinary league of scientists, engineers, entrepreneurs, thought leaders and philanthropists, an emotion that is both proud and humbling at the same time. As an entrepreneur who is driven by a sense of purpose to make a difference to global healthcare, I take pride in saying that Biocon is contributing to affordable innovation which goes to the core of ensuring a global right to healthcare. In this, we seem to be drawing lessons from Donald Othmer’s practical and low-cost approach to innovation.” EP News Bureau-Mumbai

ClinTec International bags award for biz innovation Recognises growth of ClinTec International’s Innovative Global Academy of Clinical Research Excellence CLINTEC INTERNATIONAL has received the ‘Business Innovation of the Year’ award sponsored by Microsoft presented during the Scottish Business Awards, recently held at the Edinburgh International Conference Centre. Dr Rabinder Buttar, Chief Executive Officer and Chairman, ClinTec International,

66 EXPRESS PHARMA June 1-15, 2014

received the award in a ceremony with over 1,900 business people present. Buttar said, “ClinTec International is delighted to receive this award in recognition of all its hard work and dedication. As a global entrepreneurial company, with a presence in over fifty countries, innovation is at the heart of everything

that we do.” Global entrepreneur Sir Richard Branson, said “Well done to the ClinTec team for building an entrepreneurial, innovative global business.” Branson took part in a live Q&A session hosted by the broadcaster Alastair Stewart. Amongst the many key figures present at the awards dinner

(L-R) Dr Rabinder Buttar and Sir Richard Branson

and ceremony were First Minister of Scotland Alex Salmond MSP, Secretary of State for Scotland, the Alistair

Carmichael MP and Chairman of the Awards, Sir Tom Hunter. EP News Bureau-Mumbai

PHARMA LIFE CAMPUS BEAT

NEW COURSE

Lupin,Smt Kishoritai Bhoyar Jamia Hamdard College of Pharmacy in tie up University and BD To establish industry and academia connect, maintaining long standing relationship with college LUPIN AND Smt Kishoritai Bhoyar College of Pharmacy, Kamptee signed an agreement to establish industry academia connect in the form of student encouragement, exchange and live research projects. The agreement was signed by Prof Milind J Umekar, Principal from SKB College of Pharmacy and T Vijaykumar, Head HR from Lupin, MIHAN, Nagpur. The objective of the agreement is to establish industry and academia connect, maintaining long standing relationship with college and encouraging the students through recognition and reward of the top performing students at the college. Under this tie-up, the students will be allowed for industrial training and research projects. Lupin officials will conduct regular training pro-

FACSTM eLEARN initiative to provide impetus to the standard of work carried out in Indian labs

grammes for overall development of students and faculty of college; The scholarship shall be awarded once a year to the top ranking student of the SKB college in the mentioned courses, B Pharm and M Pharm; Such students shall be recognised as ‘Lupin Scholar’; The scholarship amount shall be awarded during the annual function; The scholarship shall

also include provision for the student to pursue or undergo a live project/ training in Lupin under the guidance of a Lupin official; The college will provide research assistance to various industrial research projects of Lupin and will provide assistance in training and placements. EP News Bureau-Mumbai

Novartis BioCamp to be held in Hyderabad NOVARTIS INDIA has announced the next edition of the Novartis Biotechnology Leadership Camp (BioCamp) taking place in Hyderabad from July 20 to 23, 2014. BioCamp is a pioneering seminar organised by Novartis that brings talented students from diverse faculties and different universities closer to the pharmaceutical industry. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India, “Now in its 6th year, BioCamp has positively impacted the lives of many young minds. It provides a

Biosciences introduce Bioscience eLEARN course

great opportunity for a broad range of students to interact with leaders in the pharma industry. This seminar offers students the opportunity to get insights into the pharma industry and helps them make career choices. BioCamp reflects the Novartis commitment to furthering the cause of healthcare and education.” BioCamp is open to postgraduate students and young researchers in natural sciences, medicine, biotechnology, bio-informatics, pharmacy, business administration or law (specialisation in Intellectual

Property Rights) interested in pursuing a career in the pharmaceutical/biotechnology industry. Selected students will have the opportunity to learn from and network with leaders in the pharmaceutical and business sector as well as hone their team building skills. The top three students from the India BioCamp will represent India at the International BioCamp being held at Novartis global headquarters in Basel, Switzerland from August 24 to 27, 2014. EP News Bureau-Mumbai

JAMIA HAMDARD University and BD Biosciences, a segment of BD (Becton, Dickinson and Company), a global medical technology company have announced FACSTM e-LEARN – a joint online learning programme in cell research and diagnostic for young scientists and researchers. Dr GN Qazi, Vice Chancellor, Jamia Hamdard University said, “I am confident that academic programmes named as FACSTM eLEARN initiative will be unique blend of theoretical knowledge and hands-on exposure to the wonderful technique of flow cytometry which has found its increasing new applications in the fields of science and medicine.” These programmes are designed for professionals who are already in a job or a regular academic programme. The web module and e-mail support programme will be followed by a hands-on experience on Flow Cytometry instruments and applications. “The establishment of the BD-JH FACS Academy at Jamia Hamdard in 2012 was an inspiring initiative to our ongoing education and training programmes designed to

help increase the capacity of young scientists, researchers and clinicians on a sustainable basis. We believe this joint academic programme will be integral towards capacity development in Flow Cytometry in India,” said Varun Khanna, Managing Director, BD - India. The web-based learning course will start from July 15, 2014 and the five-day contact programme inclusive of evaluation and examination will be held between November 17 and December 19, 2014. Commencement of online application forms starts June 2, 2014 and the last date for receiving completed application form is the last week of June 2014 Flow Cytometry has been recognised as one of the important technologies that transformed the face of modern life science and biotechnology research in India. Over the past few years, the technology has witnessed continuous improvement and new emerging applications in healthcare research. The training programme comes at a time when the demand for training in Flow Cytometry is growing consistently in India. EP News Bureau-Mumbai

EXPRESS PHARMA

June 1-15, 2014

PHARMA LIFE PROFILES

Dr Harsh Vardhan: The new custodian of India’s health childcare for Delhi's middle and lower income groups. The Cancer Control Programme, the Cataract Free Delhi Programme and the Shravan Shakti Abhiyan for the rehabilitation of the elderly and the hearing impaired, were begun under his leadership. His administration also launched the Healthy City Project, the Hepatitis B Immunisation Programme and a Delhi Research Centre for Modernised Promotion of Ayurveda. Two other significant pieces of legislation that bear his stamp are the Delhi Physiotherapy and Occupational Therapy Act as well as Delhi Artificial Insemination Act. He believes, “A major and the most important task in my view remains those politicians, decision makers and those who rule have to appreciate the importance of health. They should become equal partners in health promotion movement and preventing illness. Secondly, the allocation for health should be augmented from present abysmal levels to more realistic levels. Let health be concern of one and all.” Dr Harsh Vardhan promotes the 'Human Face' of medicine and says that considerable effort is needed to inculcate these virtues among our budding physicians. He strongly feel that the biggest challenge is to change the mind-set of our healers so that poor and needy do not feel unwanted.

AFTER DEMURRING for a day, Ananth Kumar took charge as the Minister of Chemicals and Fertilizers in Prime Minister, Narendra Modi’s cabinet. In his past assignments he has handled various ministries like Tourism, Sports and Youth Affairs, Culture, Urban Development and Poverty Alleviation. Kumar represents the Bangalore South Lok Sabha constituency in Karnataka where he has been elected six times consecutively. He defeated technocrat Nandan Nilekani Chairman of the Unique Identification Authority of India. Kumar has been influenced by Rashtriya Swayamsevak Sangh (RSS), he was a member of Akhil Bharatiya Vidyarthi Parishad, the students wing of the BJP. During the Emergency, he was imprisoned along with thousands of other student activists. He was elected as the State Secretary of the ABVP and later, became its National Secretary in 1985. He later joined BJP and was nominated as the State President of BJP Yuva Morcha. He was then made National Secretary of the party in 1996. In 1998 he was re elected and was inducted into the Union Cabinet headed by Atal Bihari Vajpayee as the Minister for Civil Aviation. Kumar was born on July 22, 1959 in Bangalore, Karnataka to HN Narayan Sastry and Girija. He graduated in faculty of Arts (BA) from KS Arts College, Hubli affiliated to the Karnataka University and later, completed his bachelors in law (LLB) from JSS Law College affiliated to the Mysore University. He married Tejaswini and the couple have two daughters Aishwarya and Vijeta.

(compiled by Neelam Kachhap)

EP News Bureau-Mumbai

The new health minister of India is known for his exemplary work in implementing the pulse polio programme AN ENT surgeon, Dr Harsh Vardhan is the new Health Minister of India. Fondly called 'Doctor Saab' in the Delhi circles, Dr Harsh Vardhan is known for his simplicity and transparency at the work. The veteran politician started his political journey in Delhi and rose in ranks to become the Delhi Party President. A post he held on to till he became the cabinet minister in the Narendra Modi government. He is inspired by the teaching of Swami Vivekananda and wants to make health and education a social movement and a national goal. The country's new Health Minister started his tenure by wishing India good health. “My innings as Union Health Minister commences today. Need the good wishes and blessings of India. Wish you good health,” the minister tweeted on May 27, 2014. He is said to be remarkably accessible and has a hands-on style of functioning. He held the portfolios of Education, Health and Law in the Delhi government between 1993 and 1998 and is known for initiating the pulse polio programme. He believes that a new and integrated holistic system of medicine is the need of the hour, which should incorporate the best of all systems including Ayurveda, Siddha, Yoga, Naturopathy, Homeopathy (AYUSH) and our other ancient systems. The second child of late Om Prakash Goel and Snehlata, Dr Harsh Vardhan was born in

68 EXPRESS PHARMA June 1-15, 2014

December 13, 1954. He has an older sister and younger brother. Young Harsh Vardhan did his schooling in different schools in the Chandni Chowk area went to Kanpur to attend GSVM Medical College, from where he obtained his MBBS and later MS with specialisation in ENT. He returned to Delhi to set up a private practice as an ENT surgeon. But his restless soul, which had manifested itself earlier and drawn him towards the RSS, persuaded him to take up projects for the betterment of society. He joined the Indian Medical Association's Delhi Chapter and worked hard in East Delhi, which is his immediate neighbourhood, to build up a solidarity of medical practitioners. He held various posts in the Delhi Medical Association – from Secretary and President (East Delhi) to State Secretary and President, where he showed early signs of his leadership qualities. He is widely recognised as the man who took the original initiative to start the Pulse Polio programme in India. In 1993, then the Minister for Health and Law in the Government of Delhi launched Pulse Polio first in Delhi, which was then home to 10 per cent of polio cases in India. In 1994, on a single day (October 2, the birthday of Mahatma Gandhi), he organised the mass immunisation of 1.2 million children. He was also instrumental in bringing the first ever antitobacco legislation in India. In 1997, under his bold leadership, the Delhi Prohibition of

Smoking and Non-Smokers Health Protection Act was passed. A major pioneering initiative of Dr Harsh Vardhan was implementing WHO's Essential Drug Programme, which revolutionised government's attitudes on public healthcare. Under the concept, maximum budgetary outlay was apportioned to those drugs most needed by the people. It was henceforth known as the 'Delhi Model' and taken up by several foreign countries and at least a dozen state governments in India. The Delhi Society for Promotion of Rational use of Drugs, which is a powerful movement now, was thus born and Dr Harsh Vardhan continues to be associated with its progress. His missionary zeal touched other areas of healthcare as well. Under him, Delhi's Maulana Azad Medical College got the country's first ever Department for Occupational and Environmental Health. He launched the Matri Suraksha Programme to ensure proper mother and

Ananth Kumar takes charge as Minister of Chemicals and Fertilizers

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