Express Pharma (Vol.12, No.4) December 16-31, 2016

VOL. 12 NO. 4 PAGES 130

www.expresspharmaonline.com

Market

68th IPCE to be held in Hyderabad

Management

Complex generics: Charting a new path

16-31 DECEMBER 2016,` 40

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CONTENTS MARKET

Vol.12 No.4 DECEMBER 16-31, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury*

16

68TH IPCE TO BE HELD IN HYDERABAD

18

10TH ANNIVERSARY EDITION OF UBM INDIA’S CPHI AND P-MEC INDIA 2016, CONCLUDES IN MUMBAI

22

OPTEL VISION OPENS MANUFACTURING BASE IN GOA

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

119

Pg

Industrystalwarts marktheir presence at 4th Edition of India Pharma Awards P30: INTERVIEW

The pharma industry worldwide is facing severe challenges that it has never faced before

P47: INTERVIEW

‘Clearsynth intends to be the catalyst in accelerated discovery’

RESEARCH

43

PFIZER’S DRUG SUCCEEDS IN BREAST CANCER STUDY

44

SURPRISING MONKEY STUDY COULD LEAD TO ‘FUNCTIONAL’ HIV CURE

MANAGEMENT

39

COMPLEX GENERICS: CHARTING A NEW PATH

42

IL-17 INHIBITORS WILL DRIVE PSORIATIC ARTHRITIS MARKET TO $12.6 BILLION BY 2025: GLOBALDATA

P49: INTERVIEW

‘India is an important market for manufacture and export of pharma products’

P51: VENDOR NEWS

Borosil Glass Works Limited registers standalone revenue of ` 119.6 crores

45

NOVO NORDISK’S TRESIBA INSULIN ACHIEVES TARGET

P120: APPOINTMENT

46

ARADIGM’S INHALED ANTIBIOTIC FAILS LATE-STAGE STUDY

Cipla appoints Ireena Vittal as an Independent Director on its Board

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. 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 © 2016. The Indian Express (P) 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

Girding up for a VUCA world

T

he term VUCA, an acronym for volatility, uncertainty, complexity and ambiguity, was reportedly first coined by the US Army War College to describe the condition of the world after the Cold War ended. Post the economic downturn, the term slipped seamlessly into B school jargon. So, what are the key must-dos in a pharma CEO's play book if s/he wants to ride out the VUCA wave? For Express Pharma's 22nd anniversary issue, we asked some of these leaders to share their learnings. Here's a quick summary of some of their insights; for more details, do read our issue dated December 16-31, pages 24-38.

Embracing change spells success in a VUCA world says Jawed Zia, Country President responsible for the Novartis Group of Companies in India. For his company, this strategy has meant introducing innovative measures, which include a social business model, emerging market brands, payment by EMIs and co-pay models as a means to broaden access and meet the needs of more and more patients.

One of the major, if not the major source, of change in the pharma world is constantly evolving regulations. Adding transparency and some degree of predictability to the pace and tone of regulatory change would go a long way towards giving the industry some visibility to their future path. In his address at the OPPI AGM, Mike Warmuth, Executive Vice President, Established Pharmaceuticals Division, Abbott makes the case for working towards making a policy environment that is predictable, consistent and stable.

The VUCA world has also transformed leadership as we know it. Daara Patel, Secretary General, IDMA analyses that the days of the single “great leader” are gone, as in a VUCA world, the

How are pharma leaders strategising to survive and thrive in a VUCA world?

best leaders are the ones who harness leadership from everyone. Patel points out how CEOs of pharma MNCs have a huge challenge in meeting growth targets, as they are aware that bulk of their sales will come from countries like India, where prices of MNCs are not affordable. But companies from India cannot be complacent.

They too need to change their business model from cost competitiveness and reverse engineering and move up the value chain, through technology innovation exhorts Dr Ajit Dangi, President and CEO Danssen Consulting.

The clinical research arena possibly scores highest on the VUCA scale but trials cannot be wished away. The only way to meet this challenge, says Dr Arun Bhatt, a clinical research and development veteran, is a 'radical change in leadership approach from reactive to proactive … a collective leadership focused on skills, attitude, vision and ethics.' Utkarsh Palnitkar, who is the national head of KPMG India's Infrastructure, Government & Healthcare as well as Life Science practices, says that new business icons need to future proof their organisations by redefining them in three areas: agilities, capabilities and values. And much of this is already happening.

At an individual level, aren't we all coping with a world gone VUCA, with Prime Minister Modi's notebandi exercise? Thus as 2016 ends, we can be sure that the VUCA world will not disappear on January 1, 2017. But hopefully, we'll be better equipped to move closer to our goals. Seasons Greetings from the Express Pharma team and all the best for 2017!

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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PRE EVENTS

68th IPCE to be held in Hyderabad Delegates from across the world will congregate in Visakhapatnam from December 16 to 18, 2016

T

he 68th successive edition of Indian Pharmaceutical Congress and Exhibition (IPCE) organised jointly by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions is all set to host a large volume of business delegates from all parts of the world from December 16 to 18, 2016 in Visakhapatnam, under the patronage of Chandrababu Naidu, Chief Minister, Andhra Pradesh.

The first ever summit for

IPCE will see active support from Central and state government and non-government bodies such as IDMA, Pharmexil, etc the pharma industry in India was the inaugural edition of IPCE in 1948 at Kolkata. Over the years, this industry spe-

cific exhibition has played a vital role in showcasing the complete spectrum of the pharma industry and IPCE

India Pharma 2017 to be held in Bengaluru The event from February 9-11, 2017, will be an international exhibition and conference on pharma industry INDIA PHARMA 2017 will be held at Bangalore International Exhibition Centre, Bengaluru from February 9-11, 2017. India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the conference delegates and business visitors provided by the event.

India Pharma 2017 will cover all the sectors of the pharma industry starting from finished formulations, APIs, bio – pharmaceuticals, fine chemicals and intermediates, natural extracts, excipients and many more.

16

EXPRESS PHARMA

December 16-31, 2016

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Conferences are scheduled on February 9-10, 2017 as part of India Pharma 2017 with the theme ‘Make In India- Are We On Track?’. The various sessions planned during the conference would involve taking stock of the achievements so far and the way forward on the journey of ‘Make in India’ in pharma and biotech sector. It would be conglomeration of eminent policy makers; national and international leaders from the industry. Since pharma is a capital intensive sector which requires active involvement/cooperation of major players of formulations, technology, R&D, product development, etc, the need for much closer and frequent interactions with industry leaders from various parts of the country and the world are of paramount importance.

EP News Bureau

has always been the growth engine for the Indian pharma industry. The show has been a perfect platform for Indian pharma industry to showcase their advancement in technology and product profile in front of a large audience of national and international delegates.

With India's new initiative of 'Make in India' campaign, the show will witness a huge boost with national and international participation.

IPCE will see active support from central and state government and non-government bodies such as IDMA, Pharmexil, etc. The five federating associations of IPCA are IPA, Indian Hospital Pharmacists' Association (IHPA), Association of Pharmaceutical Teachers of India (APTI), Indian Pharmacy Graduates' Association (IPGA) and All India Drugs Control Officers' Confederation (AIDCOC).

EP News Bureau

Nigeria to launch exhibition for industrial pharma sector ‘Manufacturing Pharma’ will attract more than 100 international and regional companies MANUFACTURING Pharma, the new platform for Nigeria’s industrial pharmaceutical sector, will be held at Landmark Centre, Lagos, Nigeria from April 25 – 27, 2017.

The exhibition will attract more than 100 international and regional companies showcasing their drug excipients, machineries, packaging materials and drug manufacturing services to Nigeria’s leading pharma companies, government representatives and drug manufacturing professionals.

The Manufacturing Pharma conference programme will attract key decision makers in Nigeria’s pharma manufacturing sec-

tor. Two action-packed days will highlight presentations and high-level debates and discussions for pharma manufacturing professionals who are interested in developing their business in line with Nigeria growth path for the pharma industry. Attendees will have an opportunity to discuss the latest manufacturing trends, discover transformative technologies and enhance their best practices in pharma processing. Key leaders will also share insights on how to become global players in the pharma industry.

Express Pharma is the media partner for the event.

EP News Bureau

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POST EVENTS

10th anniversary edition of UBM India’s CPhI and P-MEC India 2016,concludes in Mumbai The event saw participation from 1,300 exhibitors, 100-plus countries with over 40,000 attendees THE INDIAN pharmaceutical industry saw the launch of the 10th anniversary edition of UBM India’s signature event, CPhI and P-MEC India 2016, one of the world’s leading pharma networking expos. This year’s edition of CPhI and PMEC expo was held between November 21 and 23 in Mumbai – for the first time, at two concurrent venues – The Bombay Exhibition Centre (BEC) while it also made its debut at the MMRDA Grounds, Bandra Kurla Complex (BKC).

This year's marquee event saw more than 1,300 exhibitors, a 100-plus countries’ participation and above 40,000 attendees. While BEC had traditional participants for CPhI and P-MEC; the concurrent venue at MMRDA Grounds, BKC also included participants for ICSE and BioPh. The inauguration of CPhI-P-MEC 2016 were held parallely at both the venues in the presence of an august gathering of industry leaders including Dr PV Appaji, Director General, Pharmexcil, Ravi Uday Bhaskar, Additional Executive Director, Pharmexcil and Satish Wagh, Vice Chariman, Chemexcil and CMD Supriya Lifesciences; among others.

UBM India previously launched the India Pharma Week (IPW), an attractive platter of ten trend-setting events that got off to a flying start on November 17, prior to the CPhI and P-MEC expo. Focusing on the pillars of business, knowledge, leadership, innovation, recognition

18

EXPRESS PHARMA

December 16-31, 2016

and networking in the pharma domain, the IPW included a Pre-Connect Congress; Women in Pharma – Power Breakfast; the India Pharma Awards; Networking Evening; Pharma Leaders’ Golf; a closed door CEO Roundtable and many more activities. The IPW transformed the CPhI and P-MEC exhibition from a wall-bound show to one with considerable intellectual value addition.

Originating from CPhI Worldwide, the CPhI and P-MEC India was first introduced in 2006. Today, it has become South Asia's leading pharma meeting place, covering every step of the supply chain, from drug discovery to finished dosage. CPhI India is an industry platform encompassing CROs, CMOs and manufacturers of API, generics, excipients and drug formulation, fine chemicals, biosimilars, finished formulations, lab chemicals and biotechnology. P-MEC, on the other hand, had manufacturers of pharma machinery and equipment, analytical equipment, automation and robotics, packaging equipment and supplies, plant/facility equipment, automation and controls, processing equipment, RFID, tableting / capsule fillers, clean room equipment, filling equipment and laboratory products.

The show has grown exponentially over the years, with domestic and foreign exhibitors and visitors engaging over significant levels of business. This year, the expo comprised exciting facets such as

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the Supplier-Finder Desk (a digital floor plan that enabled visitors find exhibitors based on services or company names), Innovation Gallery (an arena where participating pharma companies were encouraged to showcase innovations on an international platform) and Exhibitor Showcase (a platform where exhibitors demonstrated how their new product launches are going to be efficacious.)

The key companies exhibiting in the 2016 edition at CPhI

were Hetero; Nectar Lifesciences; Alembic Pharmaceuticals; Glenmark Pharmaceuticals and Aurobindo Pharma, among others. On the other hand, some of the leading companies such as ACG Worldwide; Shimadzu Analytical; Gansons; Fette and Accupack Engineering will exhibited at P-MEC. Yogesh Mudras, MD, UBM India said, "CPhI and P-MEC India 2016 is perfectly placed to provide a most comprehensive industry platform for every

company that deals with pharmaceuticals in India. With it completing a decade in the industry, the expo gave us time to look back, revaluate, and move ahead. He added, “For the future, we believe that India has a strong potential to become a hub for biopharma innovation.

The time has come for it to emerge as an innovator nation in this sector and play a leading role in collaborative research in bio pharma."

Datta Nadkarni, CMO, Ver-

ayo, said, "The CPhI-P-MEC exhibition I'm sure was a tremendous success for all participants.

It most certainly was for our company Verayo of the US, makers of 'Physically Unclonable' chips, which can be used in product authentication, track n trace with geo-positioning, and gather big data on the whole supply-chain - and readable with an NFC-enabled smartphone by anyone, anywhere worldwide. It gave us a chance to meet a lot of potential part-

ners at the show and reconnect with friends in the pharma/related industries. The show is a great 'one stop shop' to meet and discuss business, and explore strategic alliances or commercial opportunities all at one place. I think organisers should have an application to be able to search different companies by product and by booth no, marked on a map of the exhibit halls."

EP News Bureau

INDIAN PHARMA COMPANIES FORECAST 30 PER CENT GROWTH IN 2017 AT CPhI INDIA 400 surveyed companies identify domestic sales as chief driver behind unexpected rise in revenues AN IN-DEPTH research from over 400 Indian pharma companies forecast rapid growth for the Indian pharma economy in 2017. This was revealed during the 10th anniversary edition of UBM India’s signature event, CPhI and P-MEC India 2016. Amongst the growth drivers reported are strong domestic sales in the next two to three years, generic APIs exports as well as finished formulation for developed markets.

The findings show that industry confidence is now extremely high, with domestic manufacturers bullish about near-term revenue prospects, averaging a predicted 30.5 per cent growth in 2017. An analysis by sector shows that, of the 400 companies, 60 per cent believed that finished formulations would expand rapidly, while 42 per cent see APIs as the largest growth area. Highlighting the economy’s diversity and willingness to incorporate new product classes, 25 per cent of respondents regard biosimilars and biologics as a burgeoning sector in 2017, particularly following the updated CDSCO biosimilars guidelines.

Indian pharma has benefited from an exponential growth rate in the past decade, yet this has cooled in recent years whilst the industry invested in new infrastructure and improving

20 EXPRESS PHARMA December 16-31, 2016

regulatory standards. However, this new data points to a renewed confidence that will drive another period of strong growth in Indian pharma.

These findings were announced as over 40,000 attendees visit Mumbai for the special 10-year anniversary of CPhI and P-MEC India, including India Pharma week. Over the past seven days, the event helped stimulate this predicted growth as it brought together buyers from Germany, China, Italy, Japan and the US, along with Indian pharma companies for commercial discussions, knowledge sharing and analysis.

One of the underlying reasons behind the renewed confidence in the market is the improving quality standards, as 67 per cent of respondents stated they expected to meet the approaching CDSCO certification deadline on January 1, 2018.

In the past ten years the industry has largely expanded its dollar value through international exports. This is set to continue as a major growth factor in the near future, with more USFDA approvals in the last year (201 ANDA up from 109) paving the way for increased generics sales in the US. However, not only are exports increasing, but also, the gentrification of the Indian healthcare economy is leading to

an unprecedented surge in demand for domestic pharma. An impressive 70 per cent of respondents anticipate domestic sales will be the main driver of growth for Indian pharma in the next three to five years.

One of the companies surveyed, commented, “India is seeing great opportunities in a variety of areas, we are seeing strong growth in exports to developed markets, but also strong development domestically. Our pharma companies are on par with US and European standards, so we foresee more high value Indian export to developed countries at a lower rate. Domestically, more and more Indian people now have health insurance, and consumer spending is increasing as areas start urbanising rapidly, so we are also experience high levels of demand across the country, helping drive our domestic sales.”

Indian Pharma Week featured 10 tailored event including the leading PreConnect Congress, the UBM India Pharma Awards, Pharma Leaders golf, CEO roundtables, alongside the CPhI and P-MEC India exhibition, bringing together over 1,200 exhibitors. Taking place in two separate venues, the Bombay Exhibition Centre and the BKC, the exhibition connected attendees with pharma and generics companies, ingredi-

ents manufacturers, pharma machinery, packaging experts, CDMOs, CROs, biotech and biosimilar companies.

Rutger Oudejans, Brand Director Pharma at UBM EMEA, “India’s domestic market is showing extreme confidence amongst its domestic manufacturing base. The government is actively supporting the pharma industry through several initiatives such as dedicated pharma parks, boosting the biosimilars and biologics sector, and reducing manufacturing costs.

The future looks very promising for Indian manufacturing as we are seeing greater confidence along the entire supply chain, particularly across the PMEC customer base. Machinery is playing a key role in the development of the industry as it supplies the necessary infrastructure to sustain India’s growth for the next five years.

After 10 years of CPhI India, we should reflect on what the industry has achieved. India has succeeded by seeking innovative ideas and setting new limits, re-imagining what is possible and lowering costs. In the next ten years, India could see even more startling and bold innovation, as our survey findings indicate Indian pharma is set to accelerate its development, and grow ahead of analyst projections.”

EP News Bureau

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Optel Vision opens manufacturing base in Goa The 42000 sq ft facility will serve as the company’s hub for APAC region Viveka Roychowdhury – Goa Viveka Roychowdhury Goa FOUR YEARS after setting up operations in India, Quebec-based Optel Vision, part of Optel Group, became the first North American company to set up a manufacturing base in Goa. Inaugurating the facility on November 30, Chief Guest Laxmikant Parsekar, Chief Minister, Goa, welcomed their decision and commented that this was a sign that global companies are now willing to see beyond Goa as a tourist and wedding

Member IPB & Director, Smartlink and Manish Gosalia, Founding Partner, Earthlings and Managing Trustee, Goa Knowledge Foundation, among others, for their support and guidance during the set up of the facility.

Dave mentioned how it was a challenge to convince the 27-year old-Optel Group to consider India as a manufacturing hub, as the country was perceived as a low price market. He managed to convince them by pointing out that if Mercedes and BMW cars could be sold in India, why couldn’t a solution like Optel

Chief Guest Laxmikant Parsekar, Chief Minister of Goa (right) and Louis Roy, Optel Group, President, unveil the plaque at the inauguration in the presence of other dignitaries

destination.Parsekar took the opportunity to draw attention to a number of pharmaceutical companies which have made Verna Industrial Estate their manufacturing hub, thanks to the availability of a ready pool of pharmacy graduates and other talents. It is thus no coincidence that Optel Vision zeroed in on the same location, to serve the current and potential pharma customers, in India as well as in the APAC region. In addition to pharmacy graduates, Optel Vision also found the required number of skilled engineers, 45 of those employed at the Verna site are local residents. The company plans to double the headcount within the next year, while doubling its sales in the same time frame. The Goa facility is due to start its full-fledged operations by April 2017, which besides manufacturing will include a training facility for Optel Vision’s staff assigned to different projects.

Welcoming the dignitaries, Shaunak Dave, Asian Market Director, Optel Vision also thanked the chief minister and Guests of Honour Nitin Kunkolienkar,

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Vision? The argument worked and today, Optel Vision is reportedly ranked as the top provider in India in the field of integrated automatic inspection and serialisation systems for pharma production lines. Louis Roy, President, Optel Group, spoke about the need to think about what we can do to build a better world for future generations and therefore the need to build sustainable business models. This is reflected in the Group’s CSR activities, like the Group’s financial contributions, through the Canadian charitable organisation SOS Children’s Villages, to look after the education of needy children in Bhuj, Gujarat. The company has also decided to start a new initiative to sponsor the food, medicine and education of one child per employee from January 2017, starting from the new facility at Goa. The inauguration was followed by a technical seminar by Mario Simard, Senior Product Line Manager, Optel Vision and a tour of the manufacturing facility and product demonstration. viveka.r@expressindia.com

EVENT BRIEF One Brand Total Solution

DECEMBER-2016 TO FEBRUARY-2017 IPC EXPO 2016 Date: December 16-18, 2016 Venue: Visakhapatnam The 68th Indian Pharmaceutical Congress (IPC) will host IPC Expo 2016, which will be jointly organised by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions.

The expo will see a congregation of business delegates from all parts of the world. Visakhapatnam, the upcoming pharma hub will host the fair under the patronage of N Chandrababu Naidu, Chief Minister, Andhra Pradesh. With India’s new initiative of ‘Make in India’ campaign, the show will witness a huge boost with national and international participation.

Contact details University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh-530003 Ph: 0891 2526143 Mob: 7036164555 Email: loc@68ipc.com Website: www.68ipc.com

INDIA PHARMA 2017 Date: February 9-11, 2017 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the conference delegates and business visitors provided by the event.

India Pharma 2017 will cover all the sectors of the pharma industry starting

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from finished formulations, APIs, bio-pharmaceuticals, fine chemicals and intermediates, natural extracts, excipients and many more.

Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will also be showcased.

Contact details Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ ficci.com

Federation of Indian Chambers of Commerce & Industry (FICCI) Federation House, Tansen Marg, New Delhi 110001

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24 EXPRESS PHARMA December 16-31, 2016

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Embracing change: Crucial to success in a VUCAworld Jawed Zia, Country President, Novartis India, advises pharma leaders to constantly evaluate their skills and course correct to tackle the challenges in a VUCA world

T

wo years ago Harvard Business Review called VUCA a trendy managerial acronym: short for volatility, uncertainty, complexity and ambiguity. One thing is certain: we live in a VUCA world where there is increasing ambiguity, the political uncertainties and economic scenario means everything is volatile and increasing technology has meant greater complexity rather than simplicity in some ways. Change certainly is the only constant in life.

It seems as though everything is in a constant state of motion and everything needs to happen in the now. Demographics are changing the way the world view is and with greater awareness aspirations are rising. Tomorrow almost seems like a distant word.

Given this environment there will be new paradigms that will emerge and leaders will need to constantly evaluate their skills and course correct.

There is no one size fits all model for them to adopt but rather some skills which they should look to hone and qualities which they should look to adopt. Key among these qualities are: Be a visionary. This means being able to look beyond what is there in the now and project that to what it could be in the future. It is the ability to see the big picture and convey that message to not only one’s employees but also to one’s business partners. Success means taking the team with you and equipping them to handle a volatile environment.

Set aside some “me time” to

26 EXPRESS PHARMA December 16-31, 2016

“think”. This becomes even more important when everything around you is uncertain and ambiguous. It means being able to free the mind of clutter and focus on charting the best course by looking ahead. Look at how the company can innovate and deliver on its goals.

Take bold decisions. Uncertain times call for bold decisions that sometimes shake an organization. It means challenging the status quo. While the tramlines may have been

laid nothing is cast in stone.

One must be open to new opportunities and new ways of doing things.

Make agility second nature.

This becomes paramount in a world that is forever changing.

It means the ability to course correct at very short notice.

Agility needs to be embedded in the culture of an organisation. A leader who scores high on learning agility is the one who will consistently demonstrate superior performance

under adverse conditions and who will be very quick to respond to diverse and varied assignments. Companies and leaders who lack agility will perish.

Work at succeeding in a matrix environment. Increasingly global organisations function as matrix structures and the deliverables call for greater collaboration in order to succeed. A change in mindset from “Me” to “We” is now an imperative.

Above all, we need to constantly ask ourselves whether we are “playing not to lose” or whether we are “playing to win”. Only then will we succeed at doing the right thing.

Let us look a bit closer at the pharma industry. Since the announcement of the referendum date by the UK earlier this year, reams have been written about the impact that Brexit would have on the highly regulated pharma industry, particularly in terms of regulatory processes and marketing authorisation of medicines in the UK. The surprise results of elections in the US, where all the poll pundits seemed to have got it wrong, also spells a certain amount of uncertainty for the industry. The recent demonetisation in India which took everyone by surprise has got almost everyone in the country in a bit of a flap. In such a scenario, it is a given that we live in uncertain times.

In addition, technology and disruptive innovation are changing the very way we live and do business. The pharma industry cannot insulate itself from the gigantic strides being

made by way of technological advancements. augmented reality is at our doorsteps. We have already had a 3D printed drug just last year for the treatment of epilepsy. The pharma industry is keenly aware of this and is open to embracing new and disruptive technologies.

That in itself is promising for there are enough examples of companies in other industries that all but disappeared when they failed to embrace a changing technology. Think about Kodak and Polaroid and their aversion to change. Changing technologies bring about other kinds of changes as well. Skype and WhatsApp changed the way the world talks to each other while severely impacting revenues of traditional phone companies.

Companies therefore need to embrace disruptive innovation if they are to succeed.

Google, which started out as just a search engine, is now developing self-driving cars and a smart contact lens among various other ambitious projects.

Amazon is already experimenting with drones to deliver its orders.

Harvard Business Review in an article predicts that perhaps the most surprising disruptive innovations will come from bottom-of-the-pyramid entrepreneurs who are inventing new ways of delivering education and healthcare – the cornerstones of an economy – for a fraction of the cost that is currently available with market leaders. According to Jason Hwang, internist and cofounder of the Innosight Institute, a not-for-profit think tank,

( “Disruptive innovations, like we’ve seen in other industries, can bring complex and expensive healthcare products and services to greater levels of affordability and accessibility.”

Telemedicine is changing the way healthcare is managed especially in countries in Asia and Africa where costs are high, infrastructure is an issue and demand for services is seemingly insurmountable.

Teleradiology, for example, makes it possible to provide high quality tele-diagnostics to the most remote parts of a country where there are patients and scanners but no qualified doctor to actually interpret those images. Dr Arjun Kalyanpur who co-founded Teleradiology Solutions was

awarded Healthcare Entrepreneur of the Year in 2015 by Frost & Sullivan for his work in this space. Dr Sunita Maheshwari, the other co-founder and a pediatric cardiologist, has been leveraging technology to teach post-graduate students pursuing pediatric cardiology. This enables her to reach out to students in real time all over India from wherever she is and they even get credits for these classes from their different universities.

What an impact!

Take a look at Aravind Eye Hospital that is today one of the largest hospitals in the world for eye care and a brilliant example of how technology has been leveraged both for training of healthcare professionals

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and for making eye care available to the masses. The Aravind Eye Care system is a model for other providers in eye care to follow.

IBM computer Watson is being increasingly used as an advisor for research to treat medical conditions. The computer has the ability to process vast amounts of scientific data, analyse it and pull out highlights for researchers. It has been in the news recently for being a part of the Cancer Moonshot initiative and for suggesting treatment for a hypothetical cancer patient based on all medical records of that person. Around 100 hospitals in the US have begun using the technology to aid diagnosis and treatment.

What does all of this mean for the pharma industry where billions of dollars are spent on research? It means that like other industries where technology has changed the way they operate, the pharma industry too will have to keep looking at its business model. It will need to keep its eye on the ball so that it does not lose its ability to speedily respond to an ever changing environment. It should be open to collaborative partnerships where the partner may just be from a totally different industry. It is an open field – one that could spell success depending on which path is chosen.

Companies like Novartis, globally and in India, have introduced various innovative

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measures to deal with a VUCA world. In India some of its innovative measures include a social business model, Emerging Market Brands, payment by EMIs and co-pay models as a means to broaden access and meet the needs of more and more patients. It is about looking beyond the pill at patient outcomes. Collaborations with Indian pharmaceutical companies have also changed the way business is done. Gone are the days when such partnerships were rare.

Today it is all about harnessing synergies for the overall good of the patient! Tomorrow promises to bring greater challenges. It is only those who are geared to meet these challenges who will succeed!

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India: The pulse of healthcare in emerging economies India was among the first countries in which Abbott expanded outside the US, way back in 1910.

Today, more than 85 per cent of Abbott's pharma products (by value) on offer in India are manufactured locally. In his keynote address at OPPI's recently held golden jubilee AGM, Mike Warmuth, Executive Vice President, Established Pharmaceuticals Division, Abbott touches on his company's India strategy, and the need for enablers, like stable, predictable policies that can maximise the promise and potential of India. Excerpts from his speech

O

PPI recently celebrated its golden jubilee. These 50 years also run parallel to an era of significant advances in scientific and medical development in the global pharma industry. Approaches to drug discovery and early-stage testing changed, and major innovations were made in cardiovascular drugs, anti-inflammatory drugs, oral contraceptives and cancer therapies. These innovations enabled patients to manage their health better, and made safer treatment options available. Conditions such as asthma, HIV and Parkinson’s could be managed effectively because of the drug discoveries and development during this era. The industry as a whole has made significant progress, laying the foundation of a global healthcare industry that stands at about $1 trillion today.

Along with an increase in life expectancy and reduction in infant mortality, a notable achievement is that access has particularly improved over the past two decades, with the number of people with access to essential drugs nearly doubling.

Breakthroughs in the drug industry have also benefitted our colleagues in devices and diagnostics – from lab-ina-hand devices, to stents that dissolve fully in the body, to wearable technology that

28 EXPRESS PHARMA December 16-31, 2016

important insights related to innovation, access and the state of healthcare, as it stands in India today.

On emerging markets

tracks vitals and also blood sugar levels, innovations are transforming healthcare.

These changes are not driven by companies alone – consumers are demanding more – they are seekers of actionable information and medicines to manage health better. Health helps people to do more, and

achieve their fullest potential, so what we do as an industry is truly foundational.

OPPI has successfully navigated a myriad of changes in the Indian environment, contributing to the creation of an industry that is today a pharmacy to the world. Along the way, OPPI has brought us

The impact of health is strongly linked to economics – projections show that over the next two decades, chronic diseases have the potential to push millions of people (globally) below the poverty line. In economies that have characteristics such as higher out-of-pocket spends, evolving policies, rising middle class with increasing incomes, shifting disease profiles and ageing populations, the effects of healthcare are felt more intensely.

When economies emerge, improving health is among people’s top priorities. Not surprisingly, healthcare spends in emerging economies are being driven by expanding affordability. The growth in population with discretionary spending capacity is almost exclusively projected coming from emerging markets over the next fifteen years. Emerging economies are also witnessing an increase in aging populations – in the last five years, the population of people over the age of 65 in emerging markets has gone up by almost 40 per cent. This is one of the triggers in the shifting of the disease profile towards non communicable diseases.

Companies that have a presence across the healthcare spectrum have had to transform quickly to adopt to changes, especially in emerging economies. I can speak about Abbott – across nutritionals, pharma products, devices and diagnostics, we have had to ensure that our solutions address emerging market needs.

From an industry standpoint, 33 per cent of the pharma industry’s total sales in 2017 are projected to come from emerging markets, up from 23 per cent in 2012. This spike is to an extent aided by increase in access to healthcare. China, for instance, has demonstrated a health insurance penetration of up to 95 per cent.

As one of the fastest-growing pharma markets in the world, India is at the centre of that (emerging markets) focus.

India - It’s clearly the bright spot among emerging economies Increasing healthcare expenditures, the steadfast GDP growth and other stable macroeconomic factors represent the tide that will lift India, already the fastest-growing BRICS country (with an expected GDP growth rate of 7.8 per cent in 2016-17 compared to 4.6 per cent for the overall BRICS group) towards further acceleration in the coming

( years. Pharma is one of the fastest growing sectors and is expected to grow at an annual rate of 11.9 per cent over 201520, to $ 27 billion at the end of this period.

Even as the spend on healthcare is less than five per cent of the GDP and almost 70 per cent is out-of-pocket, experience shows us that as economic parameters become stronger, healthcare is usually a beneficiary. Health insurance coverage in India was traditionally low but has doubled over the past five years to ~ 26 per cent: technologies such as telemedicine have also helped improve access to quality care.

Overall, this should strengthen healthcare infrastructure, and improve some of the basic parameters such as low density of doctors and trained healthcare workers (where India lags substantially). Some companies have collaborated with the government and educational universities to create specific life sciences modules for talent interested in enhancing healthcare skillsets.

The industry has also committed resources to improve efficiency to make medicines more affordable. Policy initiatives such as Make in India are enabling localisation at pace. At Abbott, more than 85 per cent of the pharma products we offer in India are manufactured locally (by value).

Multinational companies are also customising the manufacturing blueprint to local needs, introducing stateof-the-art technologies that are more energy efficient through greenfield plants.

Creating an environment that is oriented towards research and innovation is a necessary first step in the journey towards sustainable healthcare. The recent changes in regulations around conduct of clinical trials are encouraging. Clear guidelines and consistent application of IP framework will provide better visibility to innovators, as they explore ways to make new drugs and innovations

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available in India.

Innovating for the consumer India also distinguishes itself as a powerhouse for innovation, with its scientific talent and

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flair for frugal innovation. An exciting new chapter is unfolding in India, where global healthcare companies are betting on Indian start-ups to provide a fresh direction – incubation labs and tech-oriented

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entrepreneurship are injecting a new vigour into areas such as cancer research and diagnostics.

Innovation extends beyond new molecules to breakthroughs such as better

delivery and better compliance to therapy. For instance, Abbott’s Innovation and Development Centre in Mumbai has developed some interesting solutions that demonstrate a consumer-centric mindset that

cover ) addresses the needs of our youngest consumers, helping create child-friendly formulations for conditions such as epilepsy.

Services ‘beyond the pill’ are often the critical differentiator in an out-of-pocket market. Basic patient education, improving diagnosis and enabling consumers with tools for better management of chronic conditions are demonstrative of how the India healthcare industry has tried to bridge systemic gaps.

The other exciting area for the healthcare industry in India is how digital technology is shaping engagement with doctors and end-users. A few years ago, no one would have imagined that technologies such as augmented reality, irtual reality or healthcare mobile apps could find place in a doctor’s chamber. This digitisa-

tion is changing the dynamic of how field teams engage with doctors – moving from a more product-focused to a scienceled detail, which is a cornerstone of the proposed uniform code of pharmaceutical marketing practices.

The manufacturing capability that India possesses is truly stand-out, with its wealth of scientific and managerial talent and low cost of production. The manufacturing – IT synergy, especially in increasing efficiencies and scaling research, could be the next big innovation in Indian healthcare, and also show the way for other countries.

Enablers that can maximise the promise and potential of India Even with the transformation we are witnessing, there are a few areas that can enable

delivery of healthcare to every individual.

Externally, stable, predictable policies are foundational: As the Indian regulatory framework for healthcare continues to evolve, a question that one often gets asked is how does one succeed, with such a fluid environment.

These issues are also seen in other emerging markets where policies continue to evolve, healthcare systems undergo modernisation or political structures undergo change.

The government’s intent of improving ease of doing business is definitely the right idea and all stakeholders – government, regulators and the industry – should work from a common understanding of how ease of doing business can be operationalised.

By 2020, India is likely to be among the top three

pharma markets by incremental growth and sixth largest market globally in absolute size, so it is the responsibility of all concerned to work towards a policy environment that is predictable, consistent and stable.

What MNCs can do is to empower the local organisation, in letter and spirit: Recruit talent that understands the country, its nuances and culture. Ensure that the country head is a part of global executive committees, that there is an investment budget and the autonomy to the Indiabased leaders to recruit the best-suited talent and pursue locally relevant strategies. Top management commitment, in terms of time and resources is vital.

In closing India is among the first coun-

tries in which Abbott expanded outside the US, way back in 1910. Not many know why India was the chosen one, as the other two countries that we expanded to outside the US – the UK and Canada - were culturally very similar.

But over the years, what has become clear is that the possibility of enabling healthcare access at a monumental scale and to make a difference to people’s health, enabling them to live healthier lives, is a privilege that history accords to a chosen few.

I firmly believe that Indian healthcare is at an inflection point and will lead the way, not only for emerging markets but across the world, in how healthcare is delivered, at scale. We are fortunate to be at a point in time where, in big ways and small, we are a part of this amazing healthcare revolution.

I N T E R V I E W

The pharma industry worldwide is facing severe challenges that it has never faced before Titans of the pharma industry are adjusting their sails to adapt to an increasingly VUCA world where volatility, uncertainty, complexity and ambiguity are the only constants. Daara Patel, Secretary General, IDMA, shares his views on the strategies pharma leaders should adopt to lead and stay relevant in a VUCA world, with Viveka Roychowdhury What defines leadership in a VUCA pharma scenario?

To understand and accept that change can be sudden, as the recent invalidation of ` 500 and `1000 currency notes, and the ability to adjust to the change in national interest, is of supreme importance.

The pharma industry in India has been hit by turbulence at a pace that can be best described by the term – VUCA: volatile, uncertain, complex and ambiguous. Not only are the business leaders

30 EXPRESS PHARMA December 16-31, 2016

apprehensive but most new entrants and mid-career pharma professionals are equally apprehensive about their career prospects as well as the growth of the industry.

The pharma industry worldwide is facing severe challenges that it has never faced before. In India, the scenario is even more grim with regulatory, pricing and PR challenges. To name a few : ◗ En bloc banning of most FDCs ◗ NPPA crossing its brief by bringing more and more

formulations under price control ◗ NPPA insisting on revised prices being made effective retrospectively. ◗ Serious regulatory issues with FSSAI ◗ Proposed amendment to definition of ‘New Drugs’ from four to 10 years. ◗ Taxation on pharma products to go up by at least three per cent due to implementation of GST. Either industry will absorb the increase which they can ill afford or the government

increases prices which the patient can ill afford. ◗ NGOs targeting and attacking the pharma industry and accusing it of profiteering and acting against the interest of the patients. ◗ The Damocles sword - Total dependence on China for APIs which is more dangerous than going to war with China ◗ Lack of support to R&D. Due to the above reasons there is a lot of uncertainty in the industry and further investments and expansion plans are stalled.

(

What learnings do these paradigm shifts have for pharma leaders and corporations in the emerging markets like India APAC regions?

Leaders must provide clarity so that work assignments and goals are not as ambiguous as the environment. Ambiguity doesn’t paralyse workers; it makes them insecure and stirs them up. Competent employees, when faced with ambiguity, will do what they are most comfortable doing in order to feel as if they are contributing something appropriate. Doing something, whether it’s helpful or not, makes us feel good. A leader must provide clear direction and synchronise the efforts of others while continually communicating any adjustments.

Who are the new business icons for the pharma industry and why are they the new role models?

Leading in turbulence demands the ability to utilise all facets of the human mind.

Even the most impressive cognitive minds will fall short in the VUCA world - it will take equal parts of cognitive, social, emotional, spiritual and physical intelligence to prevail.

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To be responsive and resilient, with the ability to ride out turbulent forces that cannot be avoided, and to pivot quickly to seize opportunity when it presents itself. The days of the single ‘great leader’ are gone.

® Registered trademark, Ashland or its subsidiaries, registered in various countries ™ Trademark, Ashland or its subsidiaries, registered in various countries / ©2016, Ashland AD-13749

How have pharma leaders and corporations in established markets like the US, EU etc, changed their strategies?

The US, EU pharma industries are facing wideranging changes. Above all, the rise of emerging market economies and increasing price pressures on established pharma markets require extensive adjustments to pharma business models.

Despite a generally positive estimation of the current business climate, the global pharma industry faces various challenges that endanger their current and future business development. Nearly all of them consider themselves affected strongly by VUCA challenges.

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In the VUCA world, the best leaders are the ones who harness leadership from everyone.

Apart from other leaders, CEOs of multinationals in the West have a huge challenge in

meeting growth targets. They are aware that bulk of their sales will come from countries like India, where prices of multinational companies are not affordable. It would be a real challenge for them to have

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a differential pricing mechanism in order to ensure that the sales targets are met and patients can also afford the medicines. viveka.r@expressindia.com

Are you always solving?

We are.

We are passionate, tenacious solvers who thrive on developing practical, innovative, and elegant solutions to complex problems in drug delivery, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers. ashland.com/pharma For more information, please contact us: Rohan Rastogi / +91 40 4474 8804 / rrastogi@ashland.com Ninad Kellar / +91 22 6148 4646 / nkelkar@ashland.com

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cover ) INSIGHT

Navigating through turbulent waters Dr Ajit Dangi, President &CEO Danssen Consulting, shares his tips for pharma leaders to operate and thrive in a VUCA world which is beset by myriad challenges ALTHOUGH THE acronym VUCA is of recent origin, the Indian pharma industry has been operating in a VUCA environment for quite some time.

It has been facing strong headwinds due to issues like expanding price controls, controversy regarding FDCs, ambiguity in regulatory guidelines, weak IPR enforcement, US FDA compliance issues (and now pricing controversy) as well as many factors like FMRA and AIOCD related irritants etc.

This has resulted in the Indian pharma industry not realising its full potential.

Although we are proud of achieving the distinction of being called ‘Pharmacy of the World’, (and rightly so), we have achieved this partly because of our comparative advantage of being cost competitive. Throughout the pharma value chain like manufacturing, R&D, clinical trials etc., our costs have been 30-40 per cent lower than those in the developed countries like Europe and the US. However, history has shown that cost competitiveness is seldom sustainable. The spectre of our virtual dependence on Chinese API industry, which we ignored for too long, has now begun to haunt us.

We therefore need to adjust the sails of our boats to navigate smoothly through these turbulent waters. Here are a few suggestions: Innovation: While we have reaped the benefits of reverse engineering for quite some time, now we need to move up the value chain through technology innovation. Drug discovery is one such option and many Indian majors have been

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spending upwards of 6-10 per cent of sales on discovery research. However, the outcome is sketchy as discovery research is expensive, time consuming and risky. Many global pharma companies have however prospered by innovation in drug delivery without discovering an NME. For example, Alza Corporation which studied the existing molecules for their half life and ability to penetrate through the skin, developed a slew of transdermal patches with significant commercial success. Dr Al Zafforani, the founder of Alza sold his company to Johnson & Johnson few years ago for $10.2 billion. Similarly, Sunovion (erstwhile Sepracor USA) focussed on developing improved chemical entities (ICE) by developing single isomers of racemates of existing drugs through chiral chemistry techniques and built a multi-billion dollar empire.

The global market for enantiopure drugs is estimated to be about $50 billion.

Our own Biocon’s journey from a simple enzyme manufacturer to a biotech leader in Asia is a classic example of how innovation with passion can make you stand out in a VUCA world. More recently, some companies are breathing new life into old drugs by substituting hydrogen with deuterium, a process called Deuteration.

Deuterium remains longer in the body than hydrogen as it is more difficult to break down by enzymes. Teva has already developed such a drug for Huttingdon disease which is currently undergoing FDA review. Abbott has recently launched Flash Glucose Monitoring sys-

in the US is one such option, in Indian context this path cannot be recommended, although OTC brands can be built effectively.

tem which manages diabetes by eliminating the use of finger prick. There are several such innovations which have become commercial successes.

Indian industry should explore such options which do not require deep pockets compared to those required for drug discovery.

Building Mega Brands: Although our obsession with generics has yielded good results, time has now come to build and nurture mega brands.

E.g. Lipitor (Atorvastatin) of Pfizer reached a peak global sales of about $12 billion before its patent expired in 2011. Some of our major brands like Augmentin, Corex, Becosules, Mixtard etc. are still hovering around $50-60 million. While lack of patent protection and rigid price controls have hurt brand building to some extent, sustained efforts are required to overcome these barriers.

Pharma brand building is a challenging task as prescription drugs are not allowed to be advertised. While direct to consumer (DTC) as practiced

Diversification: Expansion through diversification is one more option for sustainable growth and have been successfully employed by many non pharma companies like Reliance, Tatas, Godrej, ITC etc. who used diversification as a strategy for rapid growth, although in the pharma sector there is a limitation to this strategy. However, expansion within the healthcare sector by exploring options such as APIs, OTC, nutraceuticals, diagnostics, hospital supplies etc., each as a separate SBU, is possible. Johnson & Johnson, a leading healthcare company in the world with global sales crossing $70 billion, in 2015-16, is a case in point.

It has used this strategy successfully by operating in consumer healthcare, prescription drugs, OTC, diagnotics, hospital supplies, orthopaedic implants, cosmoceuticals, Biotech etc., each being a separate SBU, although major contribution for sales and profits come from pharma products. As healthcare trends gradually move from illness to wellness, Indian pharma companies need to capitalise on this trend by exploring options such as Nutraceuticals, Dietary supplements , nutritionals etc.

With young demographics and increasing disposable incomes, these areas will have good potential.

As pharma R&D moves from chemistry to biology, we need to get out of our comfort zone and enter the biotech area

by taking simple steps of developing biosimilars/biobetters, a global market of which is estimated to be about $20 billion by 2020. As we know, Insulin Gargine of Biocon has recently been approved in Japan, a country with stringent regulatory requirement.

Inorganic Growth: Beyond a certain point organic growth becomes little challenging and one must look for inorganic growth through M&A. In the Indian context, with over 10,000 pharma manufacturers and market leaders having only 7-8 per cent market share and over 70,000 ‘me too’ brands cluttering the market, time has come for consolidation. The rapid growth of Sun Pharma, Piramal Enterprises in just a couple of decades is a case in point.

J&J did not become a $70 billion global giant by selling baby powder and bandages, but by following a strategy of ‘String of Pearls’ by acquiring innovative companies like Janssen, Cilag, McNeil, Depuy, Ethicon, Lifescan, Ortho, Neutrogena, Centacor etc. just to name a few. We need to embark upon aggressive M&A, and in-licensing strategy not only in India but outside the country as is successfully done by many Indian majors. With Brexit, UK offers good opportunity for M&A as pound has dropped to its historical low.

While VUCA environment is unlikely to change in near future (Brexit, GST, new US President, Demonetisation of Indian currency etc.), the Indian pharma industry is resilient enough to weather these challenges inspite of the strong headwinds.

cover ) Trends and challenges in a VUCAworld Utkarsh Palnitkar, Partner, National Head – Infrastructure, Government & Healthcare National Head – Life Sciences practice, KPMG India informs that the VUCA world has thrown up a new set of exigencies and pharma leaders need to possess adaptive skills to overcome them

V

olatility, Uncertainty, Complexity and Ambiguity (VUCA) characterise any business environment today. Moreover, VUCA has led to an increased recognition that new and unprecedented risks are emerging all the time. The pharma industry is also operating in this environment, and is increasingly facing challenges in its day-today operations. Industrial complexities are being accentuated by changing demographics, technology and innovations, globalisation, products and services variations, etc.

These complexities are posing a new set of exigencies, which require pharma leaders to possess adaptive skills. It has, therefore, become highly important for leaders to foresee upcoming trends and plan ahead of the competition to succeed. The following VUCA trends and challenges are impacting the pharma industry, and leaders must prepare themselves in advance to overcome these -

Empowered patients moving towards convenience

◗ Technology Enabled Care (TEC) for improving quality, enhancing patient experience and reducing cost TEC involves the convergence of technology, digital and mobile telecommunications. It can help to effectively integrate care by empowering patients to self-manage their health. Cumulative data collated through multiple initiatives of telemedicine, telehealth, telecare, digital-health devices, mHealth, eHealth and remote monitoring solutions provides access to the verifi-

34 EXPRESS PHARMA December 16-31, 2016

able, real-time patient-generated data. This data enables physicians to plan progressive care and avoid adverse health events, keeping patients healthy even out of clinical facilities. ◗ Home-based care for convenience and flexibility Home-based care involves health, personal and support services to help people receive healthcare services conveniently at their place. The point-of-care devices and remote monitoring equipment are helping physicians to manage patients at home. Therefore, pharmaceutical companies need to align their business model to serve patients through a home-based care model. ◗ Digital apps and wearables for real-time monitoring Applications and wearables that allow patients to manage their own health outside the clinical environment are becoming increasingly important. In fact, they allow patients with greater autonomy in managing their health. For example, bio-sensing wearables such as glucose sensors and blood pressure monitors help patients and providers to access real-time healthcare data. The importance of such ‘beyond the pill’ services is expected to increase in the near future, and pharma companies need to adapt to these changes.

Greater adoption of value-based healthcare system

◗ Outcome-based care Governments, healthcare providers and payers are

moving towards an approach where the healthcare system could focus on the outcomes rather than products and services. This approach intends to manage costs by necessitating comparative effectiveness and evidence of value, so that healthcare providers can focus on patient impact. This is also leading to a transformation in the healthcare system from a ‘providerdominated and productfocussed’ system to a ‘patientcentric and customer-focussed’ model. These market dynamics have led pharma companies to think of transformative ways that could replace traditional blockbuster drugs, incremental innovation and physician-preferred models to patient-centric models.

Emergence of new competitors

◗ Entry of non-traditional players in the healthcare ecosystem Information around a patient’s clinical data and disease history are no longer a realm of the traditional healthcare establishments. Today, technology-based companies are moving into the healthcare domain with integrated platforms, and are engaging with patients constantly through wearables, apps, fitness devices and online communities.

These technology companies collect significant amount of data from a combination of sources, such as insurance claims and electronic medical records. In such a scenario, pharma companies need to either compete or collaborate with these technology companies to be able to provide

( personalised care to customers.

Shift towards superiority metrics in clinical trials

◗ Increase in superiority trials for marketing Nowadays, superiority clinical trials are being performed frequently as healthcare providers and patients want to take an informed decision to accept a new or existing drug over its competitors. The onus is on the pharma companies to

ical data. 3D tissue modelling through computer simulation can help pharma companies to access potential toxicity. Further, clinical trials can be monitored real-time and patients can be identified for enrolment

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based on social media analysis.

Strategies adopted by global pharma companies to tackle VUCA challenges In order to stay competitive, deliver effectively, and to fu-

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ture-proof the company against VUCA times, global pharma companies have adopted various strategies. A few such cases are mentioned below: ◗ A global pharma company has adopted the following

themes to shape its strategies: ◗ A global pharma company has taken the following restructuring exercise to tackle high business cost, claims of unethical sales practices and increased competition.

It has become highly important for leaders to foresee upcoming trends and plan ahead of the competition to succeed establish the value of their drugs for healthcare providers and patients.

An Investment in Drug Protection

Rising pressure to improve efficiency and profitability

◗ Increase in M&A activities Due to the high costs involved in marketing, and R&D of new products, pharma companies are generally involved in M&A activities. Many companies are selling their noncore business, replenishing their new drug pipeline and buying products aligned to their core strengths. This trend is expected to continue in the near future and could impact the pharma industry significantly. ◗ Advanced analytics to improve drug pipeline In research and development (R&D), advanced predictive modelling and simulation techniques would help leverage the available molecular and clin-

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cover ) Indian pharma industry in VUCA times Pharma companies have long relied on successful launches of generic drugs in India and abroad. However, pharma companies need more preparedness as compared to any other industry for VUCA. The new and previously unconsidered threats are re-emerging all the time, leading to increased recognition of VUCA challenges.

Bolt-on- acquisitions ◗ In early 2015, the company has completed a significant portfolio transformation deal with a British pharmaceutical company, and the company is now focussing on bolt-onacquisitions ◗ Some of the focus areas of bolt-on acquisition include pharmaceuticals, differentiated generics surgical and ophthalmic pharmaceuticals

Cross divisional synergies ◗ The company is streamlining and consolidating its IT applications and is scaling up operations at Global Service Centres ◗ It also plans to centralise manufacturing operations across all its divisions to improve capacity planning, lower costs, enhance quality and develop new technologies

Learnings for pharma leaders

◗ Focus on new drugs to shore up growth: There is a need to increase R&D spending to master more complex therapies, as the prices of basic generic treatments fall. Also,

Pharma companies need to be more prepared for VUCA. The new and previously unconsidered threats are reemerging all the time, leading to increased recognition of VUCA challenges success in complex therapies offer greater profits abroad. ◗ Adoption of M&A route for expansion: An M&A route in the global arena could help Indian companies increase their market access and strengthen their position in a particular country. Moreover, Indian companies also need to follow asset-swapping deals

36 EXPRESS PHARMA December 16-31, 2016

Increase medicine access ◗ The company is providing an innovative portfolio of products aimed at increasing access to medicines against cardiovascular diseases, diabetes, respiratory illness and breast cancer among the middle- and low-income countries ◗ This strategy can help the company to hold on to its patents and brands while mollifying emerging markets, such as India

Technology and innovation ◗ In January 2015, the company had formed a $100 million digital health investment company to back‘beyond the pill technologies’products or services ◗ To improve innovation, the company plans to establish a single Global Head of Drug Development to improve resource allocation, IT and values between divisions.

It also aims to integrate clinical enabling functions, such as safety, regulatory and pharmacovigilance to foster innovation

A global pharmaceutical company has taken the following restructuring exercise to tackle high business cost, claims of unethical sales practices and increased competition

Realigning business The company has divested its oncology business to a Swiss pharmaceutical company.Also, the two have created a consumer healthcare joint venture

Cutting cost The company has announced a cost-cutting plan that aims to cut costs of USD1.6 billion over five years

New sales model The company plans to launch a new sales force compensation programme with the removal of individual sales target.These policy changes appear to be an important step in the direction of rationalising commercial spending

to strengthen their product portfolio in a particular segment and remove non-core assets. ◗ Embrace technology to increase efficiency: The Indian pharma industry is often slow to adopt new technologies. However, technology

adoption can increase supply chain efficiency and compliance to international standards. The adoption of digital technology can also help the companies to market their products and services in an effective way to end-customers.

Business icons for the industry

agilities, values.

As the healthcare industry is moving to a value-based healthcare system, the new business icons can future proof their organisations by establishing an ongoing process of redefinition in three areas —

(Disclaimer: The views and opinions in this article are those of the author and do not represent the views and opinions of KPMG in India)

capabilities

and

(

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Leadership strategy to SAVE clinical trials in India from VUCA Dr Arun Bhatt, Consultant – Clinical Research & Development, advocates the need for collective leadership which focusses on Skills, Attitude, Vision and Ethics (SAVE) to make the Indian clinical trials sector ready to deal with the challenges in a VUCA world If you want to know your past, look at your present conditions.

If you want to know your future, look at your present actions - Chinese Proverb

V

UCA, an US Army framework to describe volatility, uncertainty, complexity, and ambiguity, has pervaded all industries. Volatility is a state of dynamic instability brought about by rapid change in environment. This creates a state of uncertainty – lack of clarity about the present situation that hampers managerial ability to visualise the threats and challenges facing the organisations. Complexity is characterised by a situation where multifactorial interplay of threats and opportunities can cloud capacity to make a judgement.

Ambiguity brings in lack of clarity about awareness of a situation and predictability of the outcomes.

Since 2013, when the Indian regulatory authorities released new regulations, guidelines new

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cover ) orders in response to Supreme Court directives, the discipline of clinical trials has faced the challenge of VUCA. Rapid introduction of rules, regulations, and orders – compensation, registration of EC, audio-visual recording of consent, sponsor undertaking for marketing new drug in India after completion of clinical trial, restricting number of trials per investigator, serious adverse event reporting requirements - and setting up of three committees for clinical trial review - and expert committee for compensation, and regulatory inspection at clinical trial sites has made the environment volatile, uncertain and unpredictable, complex and ambiguous impacting the growth of discipline of clinical trials in India. These regulatory changes impacted all stake holders. The institutions, investigators and ethics committees lost interest in conduct of clinical trials as the increased burden of regulatory compliance activities far outweighed the perceived benefits of conducting clinical trials. For foreign pharma companies, India lost its attractiveness as a cost effective clinical destination. Indian research and development (R&D) based pharma companies had to consider alternate foreign destinations, which increased development cost. Drastic decrease in number of trials caused loss of jobs. The situation is slowly improving because of some pragmatic changes in regulations.

However, the question for the industry is how to prepare for such challenges in future.

Col Eric Gill (Harvard Business review 2010) has recommended several strategies to lead effectively in VUCA environment - clear communication, meaningful usable information, agile leadership, flexibility, collaboration, training, listening and thinking divergently. These strategies would be useful for an individual leader to improve situational awareness and strive for predictable outcome for her organisation and team. However, in the long term, only collective leadership will be effective in managing the challenge of

38 EXPRESS PHARMA December 16-31, 2016

VUCA scenario for the country.

The pharma industry associations – IDMA, OPPI, IPA the clinical research associations – Indian Society for Clinical Research (ISCR), leading public and private medical institutions, should come together to provide leadership and support longterm growth of discipline of clinical research. The leadership should develop a vision for clinical research which ensures ethical conduct of clinical trials, and should support development of skills, with a proactive attitude.

Conducting quality trials in India Ethics should be the top priority in the conduct of clinical trials.

There should be a common ethics code to conduct quality clinical trials, which ensures protection of rights, safety and well being of subjects. The clinical drug development should focus on unmet medical needs of Indian patients.

Skills include knowledge, education, and awareness. It

VUCA in the clinical trial environment require a radical change in leadership approach – from reactive to proactive is vital to develop a training programme for all the stake holders – investigators, site teams, ECs, and industry professionals. The programme’s principle elements should be accreditation and focus on science, ethics and regulations for clinical research. It should provide uniform training to ensure compliance with regulatory laws and guidelines, and to ensure protection of rights of clinical trial participants. Skill develop-

ment should be reinforced by providing the trained investigators an opportunity to conduct research in epidemiologic observational research studies of relevance to Indian healthcare needs.

The participant is the most important stakeholder in clinical trials. There is an urgent need to create clinical research awareness programmes for patients, patient groups and society.

European Patients’ Academy on Therapeutic Innovation (EUPATI) - a consortium project, led by the European Patients’ Forum, with 30 project partners across Europe from patient organisations, academic institutions, and pharma R&D companies – aims to increase public knowledge and understanding of medicines R&D, and to help the public communicate more effectively with health professionals about new medicines. EUPATI has plans to develop a training course which aims to increase patient experts’ capacity to become actively involved in medicines R&D. They are also developing a toolkit for patient advocates to facilitate dissemination of medicines R&D information to patients, and an online library of medicines R&D information for the public. It would be worth emulating this programme and adapting it to Indian realities.

The Indian patient education programme should create awareness about: 1) Clinical research process and its value in improving public health and in developing a new drug 2) Regulatory mechanisms for human subject protection 3) Clinical trial participants’ rights. These include rights of a) Safe, considerate and respectful, professional medical care b) Protection of privacy and confidentiality c) Adequate information to give voluntary informed consent d) Receiving medical care in case of any medical problem and serious adverse event (SAE) e) Receiving compensation in case of SAE related to clinical trials

f) Withdraw from clinical trials without penalty or loss of benefits g) Special protection and care as vulnerable subjects and h) Post-trial access The leadership would require a proactive attitude to meet the above challenges. This requires serenity to accept things which they cannot change, and the courage to change things that they can change. The leadership should accept that the recruitment of Indian clinical trial participants will always pose challenges literacy and poverty and the government would expect that the rights, safety and well being of such vulnerable participants remain a prime consideration while conducting the trials.

Whenever there are safety issues and violation of clinical trial participants’ rights, the government will react by making relevant changes in regulations and guidelines to provide assurance of human protection in clinical trials. However, the leadership can change the negative image about clinical drug development by coming together with the objective of improving knowledge and skills of all stakeholders, of empowering clinical trial participants and improving ethical quality of clinical trial conduct in India. This leadership team can also provide uniform feedback to regulators and policymakers and work with them to create regulatory environment which is robust, transparent, and responsive to global and national expectations of ethical and quality clinical trial conduct.

VUCA in the clinical trial environment require a radical change in leadership approach – from reactive to proactive. A reactive response means stopping trials, downsizing manpower and closing operations.

But this response won’t change the state of VUCA in the recent past or won’t reduce the potential for VUCA in future. Only a collective leadership, which focusses on Skills, Attitude, Vision and Ethics (SAVE) can save the discipline of clinical trials, and make it ready to deal with the challenges in a VUCA world!

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WHITE PAPER

Complex generics: Charting a new path A QuintilesIMS report finds that complex generics is a lucrative market for drug manufacturers, but only if they can adapt to a more complicated and challenging development process

G

enerics have been an attractive, lucrative development path for more than three decades. As the market has become saturated with simple generic products, biopharma companies are turning their focus to complex generic drugs, which deliver more value to patients by addressing additional unmet needs and which enable them to achieve market differentiation and opportunities for higher margins.

However, developing complex generics in an era of rising costs and increased scrutiny over international development and manufacturing operations requires a higher level of expertise than is required for simple generics development. It demands a more sophisticated planning and development process, and a deep understanding of the regulatory, quality and health technology assessment (HTA, pricing/reimbursement) environment to bring these drugs to market.

“Complex Generics: Charting a New Path”, a Quintiles IMS report, explores the complex generics landscape and the challenges developers face bringing these drugs to market, and offers best practice advice for overcoming obstacles in order to benefit from this profitable shift in the marketplace.

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Challenges in developing a complex generic As opportunities to develop simple generics are less attractive, many companies are setting their sights on complex generic drug development. The challenges in bringing complex generics to market include: ◗ The need to identify new commercial and regulatory strategies, and identify targeted markets and indica-

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KEY CONSIDERATIONS FOR...

Navigating the regulatory environment

◗ Research similar approvals and predicate products.

In the absence of guidance from regulatory authorities, biopharma companies should review the strategy of the originator and research summaries from similar drugs to inform their development plan. ◗ Be clear which regulations you need to follow and what that entails. It is important for biopharma companies to understand these regulatory requirements from the outset and to incorporate them into the overall development plan. Most complex generics will utilise the 505(b)(2) procedure for approval in the US with specific criteria for the size and scope of trials. ◗ Apply good regulatory practice in interactions with agencies and precedents.

Regulators won’t answer open-ended questions, but they will offer targeted feedback regarding existing plans, and answer scientific questions to further hone the details.

tions to address unmet patient need ◗ A lack of guidance which makes it incumbent to develop effective strategies togain regulatory approval ◗ Competition for patients in key markets. ◗ Increased scrutiny from regulatory agencies for quality systems and data integrity ◗ The need to bring these products to market rapidly and effectively to gain limited exclusivity These challenges add time, cost and risk to the project.

Biopharma companies that choose the right partners to help

40 EXPRESS PHARMA December 16-31, 2016

Planning and study design

◗ Complex generics often lack clear guidance from regulatory agencies. In this respect these projects are more similar to innovative drug development, and require biopharma companies to think more strategically about the protocol, engagement with regulatory bodies, study design, locatio n(s), trial parameters and data needed to gain aproval. ◗ Design with the end in mind. As important as it is to achieve equivalence in the lab, to be successful the study design should have a clear scale up and transition plan to ensure consistent quality in the manufacturing stage. ◗ Factor population and access to patients into study plans. Biopharma companies need to understand exactly what type of patient will be required in their trials to achieve approval in their target markets. They should take into account where those patients can be accessed, and how they will accommodate the risk of attrition and non-compliance among limited patient populations. ◗ Look for opportunities to accelerate and mitigate risk. To reduce risk and speed trial results, biopharma companies may choose an adaptive design approach, in which they begin the trial with limited patient exposure. This cuts time and cost, while enabling them to adapt the protocol based on early results.

Generics projects

◗ Make a compliance plan. Every complex generics project plan should include a compliance component that lays out what each partner needs to do to achieve compliance, and how the biopharma company will oversee and audit that compliance. ◗ Have a dedicated compliance expert on the internal team. This drives a focus on compliance throughout the lifecycle of the project, and demonstrates to regulators that project leadership has the expertise to avoid most problems, and to solve any issues that do arise. ◗ Balance the need for speed with compliance. There is enormous pressure in the generics space to be first to market, but if a drug can’t win approval, or gets to market on the basis of faulty data, biopharma companies risk more than poor profits. It can devastate their brand, and present serious patient safety implications, especially when these drugs are designed to treat chronic and deadly diseases.

with their product development and regulatory strategies can profit significantly from this next big phase in the generics marketplace.

Part 1: Understanding regulatory requirements and the target market Simple generics generally have a clear development roadmap which usually includes guidance from the FDA Office of Generic Drugs (OGD) describing endpoints and data required for US approval. With complex generics, developers are less likely to find regulatory guidance, which adds uncertainty and risk to the

planning and design process.

Having a clear regulatory strategy that leads to product approval is crucial for these projects. To ensure they are on the right path, developers should meet with regulators early on to present their development strategy and review their study design and comparability studies before they move forward. This enables developers to optimise their program, streamline filings, and avoid surprises during the marketing application assessment process.

Part 2: Planning and study design

Site selection

◗ Choose a partner who has a demonstrated ability to locate disease specialists. Because complex generics are relatively new, there could be skepticism among sites to participate in a complex generics trial. Many investigators may not be interested in generic drug trials due to lack of scientific or medical interest in non-novel drug trials or because they anticipate that patients themselves may be less enthusiastic about participating in a complex generics trial. Therefore, biopharma companies need a partner who understands how to identify sites with an adequate patient pool and interested in accessing generic options through trial participation. ◗ Invest in sites. An effective site strategy for complex generics includes willingness to provide additional support in cases where a site has the appropriate populations of patients and specialists but limited or no research experience. This support strategy could include providing staff, education, and/or oversight to help them ramp up their trial capabilities. This increases the likelihood that the biopharma company will have access to the necessary patients and be able to expand their site network for ongoing trials. ◗ Talk-up the value proposition. A good site selection team will encourage research naïve sites to participate in a generic trial by offering additional education and training, and communicating the value of participating in a successful complex generics trials. ◗ Start early. Biopharma companies should begin working with their partners on site outreach as early as possible to minimise lag time in recruiting, and provide enough time to train staff and upgrade site infrastructure, tools and templates prior to the first patient enrolled.

Pursuing complex generics

◗ Assess regulatory requirements for complex generics development including predicate products ◗ Conduct a detailed gap analysis of the necessary skill set to identify areas of risk ◗ Access guidance and relevant available data to inform the development roadmap ◗ Develop a robust clinical strategy ◗ Acquire scientific advice via regulatory meetings

In most cases with complex generics, the plan will require clinical studies beyond what is typical of a simple generic product, and that should be taken into account from the outset.

When planning these trials, the time, location and cost of recruiting in a particular region, especially if there is competition for patients and/or site resources, should be taken into account.

Part 3: Site selection: Right sites, right start Biopharma companies interested in pursuing complex generics should choose partners

who can navigate the unique challenges in finding trial sites that have the expertise, interest, and access to targeted patient populations. In many cases, the sites most capable of delivering these projects may not be interested in participating in a generics trial, while those that are interested may lack the experience to manage the additional investigational requirements that complex generics trials require.

To minimise the risk, biopharma companies should look for partners who have extensive site networks, and the ability and willingness to educate novice site leaders who are

MANAGEMENT interested in expanding their offerings and taking on more complex projects. Because these support strategies require additional education, tools and oversight to these sites, biopharma companies should begin working with their partners on site outreach strategies early on in the research process.

Part 4: Compliance as a competitive advantage Biopharma companies need to carefully evaluate whether they have the equipment, training, knowledge, leadership and commitment to follow compliance rules especially in the face of pressure to cut time and cost from the project.

Along with managing the rapid timelines and complex development process, biopharma companies must be rigorous in their adherence to good manufacturing and compliance planning to avoid regulatory issues that could delay regulatory approval. Often, the development phase is rushed to expedite regulatory submission, and manufacturing and QC managers bemoan the fact that R&D staff did not take adequate care in creating, transferring and validating analytical methods and manufacturing processes.

All of these compromise increase compliance risks for any development project, but with complex generics projects compliance concerns get more complicated – especially when working with novice sites and manufacturers, or those that have only worked on simple generics projects. Complex generics development plans generally require more nuanced methods and rigorous testing to meet all efficacy, safety and equivalence goals.

They also face increased compliance risks in the transition process from pilot project to manufacturing where processing issues can impact identity, quality, purity, potency and consistency from batch to batch.

Conclusion Complex generic drug development is the current wave, and companies that can adapt to a more complicated development process are positioned to profit greatly in the years to come. Biopharma companies should adopt

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Good Regulatory Practices in defining where, what, when, and how to achieve crucial “time-tomarket� strategic and operational goals. To avoid pitfalls in the transition to complex generics, biopharma companies should choose industry partners with clinical experience and global regulatory know-how, along with site networks and

quality/compliance expertise to rapidly deliver validated results.

Such collaborations enable developers to optimise their study design, simplify project scope, and speed patient recruiting so they can meet the needs of regulators in shorter time lines and at lower costs, while helping to ensure the long term supply of quality product.

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REPORTS

IL-17 inhibitors will drive psoriatic arthritis market to $12.6 billion by 2025: GlobalData The relatively strong growth will primarily be driven by the increase in diagnosed prevalent cases THE PSORIATIC arthritis market across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, is set to grow from $4.53 billion in 2015 to around $12.6 billion by 2025, at a compound annual growth rate of 10.74 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that the relatively strong growth will primarily be driven by the increase in diagnosed prevalent cases. The launches of interleukin (IL)-17 inhibitors, such as Eli Lilly’s Taltz (ixekizumab) and AstraZeneca’s Lumicef (brodalumab), as well as Celgene’s oral therapy Otezla (apremilast), will also drive

the market, and will provide more treatment options for physicians.

Alexandra Annis, Analyst, GlobalData covering Immunology, explains, “Reasons for the increased diagnosed cases of psoriatic arthritis include better awareness of the disease due to educational campaigns and an interdisciplinary approach to managing the condition between dermatologists and rheumatologists. As such, the number of total treated cases in the 7MM is expected to increase from around 770,000 in 2015 to almost 1.2 million by 2025.”

The psoriatic arthritis community has welcomed the recent approval of Novartis’ IL-17

The launches of interleukin (IL)17 inhibitors will also drive the market and will provide more treatment options for physicians inhibitor Cosentyx, which touts the highest clinical efficacy of any biologic yet approved.

X-ray assessment data has

demonstrated that 84 per cent of patients showed no further progression of structural joint damage over two years of Cosentyx.

Annis continues, “The psoriatic arthritis market will be full of therapeutic options, with nine branded biologic drugs on the market over the forecast period. This includes the recent approvals of Lumicef and Taltz in Japan, as well as an oral systemic therapy, Otezla, and three new biologic and oral drugs in the late-stage pipeline.”

“The lack of long-term efficacy for psoriatic arthritis treatments causes patients to have to cycle through the drugs. Thus, the addition of

drugs with strong clinical efficacy provides a better choice of therapies for physicians and patients.”

GlobalData expects most of the current pipeline products will be launched by mid-forecast, with Lumicef and Taltz leading the way. In 2025, with all of the approved drugs trying to jockey for position and stand out among the rest, Taltz will gross an estimated $1.42 billion in total drug sales—the highest among IL-17 inhibitors. Overall, a crowded treatment space and a constant need for reduced drug costs mean new entrants will find it difficult to make an impact on the psoriatic arthritis therapy space.

EP News Bureau

Asia-Pacific anti-hypertensive therapeutics market to hit $27 bn by 2022: GBI Research Growth will not be aided by the weak anti-hypertensive pipeline, due to lack of innovative products in late-stage development THE MARKET for anti-hypertensive therapeutics across the five Asia-Pacific (APAC) countries of India, China, Australia, South Korea, and Japan, is set to grow from $19.1 billion in 2015 to $27 billion by 2022, at a compound annual growth rate of 5.1 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that this relatively solid rise in market value will be driven by the increasingly elderly population – where the prevalence rate of hypertension is highest – and increases

42 EXPRESS PHARMA December 16-31, 2016

in risk factors such as obesity, low physical activity levels, urbanisation, and smoking. Indeed, growth will not be aided by the weak anti-hypertensive pipeline, due to lack of innovative products in late-stage development.

Gautam Arora, Analyst, GBI Research, explains, “The anti-hypertensive pipeline consists of 112 pipeline products, most of which are small molecules. The limited presence of other types of molecules in the pipeline suggests that large pharmaceutical companies are refraining from developing

novel molecules and are more inclined to focus on patientcompliant combination therapies. It is therefore unlikely that any completely novel molecules will enter the market during the forecast period.”

“Prestalia is an example of a recently improved drug that offers an improvement to hypertension therapy. In a Phase III trial it provided a better benefit-to-risk ratio than either treatment alone. The drug was approved by the US FDA in January 2015, and it is marketed by Symplmed. Of the APAC countries covered in the

report, however, it is available only in Australia, and it is under development in Japan and South Korea.”

Overall, late-stage products will not change the treatment paradigm of hypertension during the forecast period. With the lack of any new premiumpriced drugs in this setting and the prescription of relatively cheap generic versions of antihypertensive drugs to continue, GBI Research expects the status quo of drug treatment to persist in the APAC region.

Arora concludes, “Despite the availability of a large num-

ber of blood-pressure-lowering agents, the need remains for safer and more effective antihypertensive treatments. Although the APAC market is likely to see steady growth, it will continue to be obstructed by a weak pipeline and low diagnosis and treatment rates.

Indeed, the asymptomatic nature of the disease along with a lack of frequent blood pressure checks due to limited affordability and healthcare accessibility in countries such as India and China can limit diagnosis rates.”

EP News Bureau

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UPDATES

Pfizer’s drug succeeds in breast cancer study Biotech drugs such as Herceptin are made in living cells, and then extracted and purified

P

fizer said that its experimental biosimilar of Roche Holding’s blockbuster breast cancer treatment Herceptin was found comparable with the branded version in a key study. Biotech drugs such as Herceptin are made in living cells, and then extracted and purified. They are more complex than traditional drugs and cannot be copied with precision.

Unlike generic drugs, which are interchangeable with their branded counterparts, biosimilars approved by the US Food and Drug Administration to date are not considered interchangeable. Several companies are developing biosimilar versions of top-selling biotech drugs.

Pfizer tested the safety and effectiveness of the drug, PF05280014, in combination with chemotherapeutic agent paclitaxel against Herceptin and paclitaxel in previously untreated patients with HER2-positive metastatic breast cancer.

Mylan NV asked US regulators earlier this month to approve its own biosimilar form of Herceptin, being developed with India's Biocon, after it was shown to be similarly safe and effective as Roche's drug in a large late-stage study.

Amgen and partner Allergan are also racing to develop a Herceptin biosimilar, which has showed it is comparable with the branded version in a late-stage trial. Herceptin, which is also used to treat gastric cancer, generated global sales of more than $6.5 billion in 2015, making it one of Roche's top products.

Biosimilars are not expected to become available for at least another year or two in the US. The US patent on Herceptin is slated to lapse in 2019, although some industry analysts believe a biosimilar could be launched as soon as 2018.

Reuters

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Surprising monkey study could lead to ‘functional’HIVcure All nine monkeys that got both treatments showed significantly reduced viral loads DR ANTHONY Fauci doesn't get too excited about the results of animal studies, and he doesn't make house calls.

But when a drug already taken by thousands of people for intestinal conditions appeared to control the monkey version of HIV, it got the attention of the director of the National Institutes of Allergy and Infectious Diseases.

Fauci hopped on a plane to Cambridge, Mass., to personally tell Japan's Takeda Pharmaceutical's US representatives that their drug may offer a dramatic advance in the fight against AIDS. Takeda’s drug suppressed the virus to undetectable levels in eight monkeys, some for two years. The findings raise hopes for a so-called 'functional cure' – a treatment that puts the disease in sustained remission.

'The data was so dramatic,' said Fauci, who has made AIDS research his life’s work.

The drug is one of several promising ideas heading into early-stage human trials, all seeking to help patients control the virus that causes AIDS for extended periods without daily antiretroviral therapy (ART).

The studies build on research propelled by the case of Timothy Ray Brown, the so-called 'Berlin patient,' whose HIV was eradicated through an elaborate stem cell transplant in 2007.

"There has been this explosion of discovery," said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition. "There are completely new ideas that were impossible to conceive even a few years ago."

HIV once meant certain death. But, for more than half of the 36.7 million HIV patients around the world, ART transformed it into a chronic disease.

44 EXPRESS PHARMA December 16-31, 2016

Taken daily, ART suppresses the virus. But keeping up a daily medication regimen is difficult.

The drugs are expensive and toxic, causing nausea, fatigue and nerve problems in the shortterm, and insulin resistance and other problems over time.

Only about a third of US patients take ART consistently enough to push the virus down to undetectable levels.

“We're going to need other approaches," said Dr Nelson Michael, Director of the US Military HIV Research Programme at the Walter Reed Army Institute.

Much work has focused on the discovery of rare antibodies made by HIV patients that can neutralise several different forms of the virus. One trial involving an antibody called PGT121 licensed by Gilead Sciences reduced the virus to undetectable levels in 16 of 18 monkeys; the effect lasted for four months in three of them.

At Walter Reed, Michael is taking a different tack, testing

whether a vaccine - being developed to prevent HIV infection can fight off the virus in infected individuals.

Last month, Michael and researchers at Harvard's Beth Israel Deaconess Medical Center published the results of a monkey test of Johnson & Johnson's HIV vaccine candidate called Ad26/MVA and Gilead's experimental drug GS-986.

On its own, the vaccine had a modest effect. But it was even more effective when it was given with GS-986, a so-called TLR-7 agonist that “kicks the immune system up to a higher gear,” Michael said.

All nine monkeys that got both treatments showed significantly reduced viral loads. In three, the combination therapy has kept the virus at bay for at least six months.

Human trials could begin within months, said Dr. Paul Stoffels, J&J's chief scientific officer.

"If the cure is there, the industry will find a way to get

there very quickly," Stoffels said.

Fauci’s visit was a first for Takeda, a company focused on treatments for cancer, gastroenterology and the central nervous system, said Dr Michael Shetzline, who heads clinical science for Takeda in Cambridge.

“The excitement was just clear,” Shetzline said. “It was like, 'Wow.'" Takeda does not study HIV. But its researchers understood the basic science surrounding its drug Entyvio, an antibody engineered to attack a specific protein.

The drug, known generically as vedolizumab, is approved in more than 50 countries for ulcerative colitis and Crohn’s disease, which occur when the immune system attacks the intestines.

"Entyvio is a cell trafficking molecule that affects immune responses," Shetzline said. "In this instance, the GI tract is what is harboring this HIV cell population that needs to be cleared at least that is what the monkey

study implies."

Takeda is providing the drug and supporting the study. Shetzline cautioned that it's only a pilot.

"We'd love to see this benefit patients,” he said.

If it pans out, cost could be an issue. Entyvio is priced as a biologic, similar to other IBD treatments, which range from $2,000 to $5,000 a month, according to Consumer Reports.

Entyvio's HIV trial began in August and seeks to enroll 15 to 25 people with stable disease.

They will remain on daily ART drugs while taking nine infusions of Entyvio over a period of several months. Then, ART will be stopped, they will get two more infusions, and doctors will watch to see if the virus rebounds – or remains suppressed.

Manni Baez, 30, of Columbus, Ohio, travels to the National Institutes of Health in Bethesda, Maryland, about once a month for the study.

“For me, the end game is providing the folks at NIH with the resources they need to get them closer to finding a cure or a vaccine for this plague," Baez said.

Fauci said he doesn’t expect meaningful results until late 2017 or early 2018. Even partial success would be huge, he said.

"If we discontinue therapy in the 15, and four of them don't rebound,” he said, then “that is the best anybody has ever seen.”

Fauci said he doesn’t get emotional about the data he collects, and, in any event, it’s early days for this research.

“I try to be as objective as I possibly can,” he said. “I will get really excited if we get our first seven people in human (trial), and I stop ART - and they don't rebound.”

Reuters

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Novo Nordisk’s Tresiba insulin achieves target Tresiba also showed a statistically significant 40 per cent overall reduction of severe hypoglycaemia in patients NOVO NORDISK'S long-acting insulin blockbuster Tresiba has a safe cardiovascular profile and reduces episodes of severely low blood glucose levels in patients with Type II diabetes, the Denmark-based company said.

Type II diabetics which need insulin to control their blood sugar risk having too low levels of glucose in their blood, which can cause tiredness, confusion and in some cases unconsciousness.

The so-called DEVOTE study, involving more than 7,500 patients, demonstrated Tresiba's non-inferiority of major adverse cardiovascular events to rival Sanofi's long-acting insulin Lantus (insulin glargine), Novo said.

Tresiba, a once-daily basal insulin which keeps a diabetic's blood glucose levels stable between meals and during sleep, also showed a statistically significant 40 per cent overall reduction of severe hypoglycaemia in patients. Patients treated with Tresiba also experienced a 54 per cent lower rate of nocturnal hypoglycaemia.

Novo Nordisk faces tough price pressure in its biggest market, the US, and slashed its longterm growth guidance in its October earnings, causing shares to plummet.

The company also axed 1,000 jobs and announced the discontinuation of several pipeline projects, including what is commonly referred to as the holy grail among diabetes drugs, insulin in a pill form.

Novo has already applied for a label description update for Tresiba in both the EU and the US after trials earlier this year showed therapy with Tresiba led to fewer episodes of low blood sugar levels (hypoglycaemia) compared to therapy with Lantus. Novo expects to submit findings from the DEVOTE study for review with regulatory authorities during first half of 2017.

Reuters

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Aradigm’s inhaled antibiotic Flu - or flu vaccine - in pregnancy not tied to fails late-stage study The main goal of two late-stage trials was to show an increase in the median time taken till the first instance of a pulmonary exacerbation

ARADIGM CORP said that its inhaled antibiotic for a rare, incurable disorder affecting the lungs failed in a late-stage study. The once-aday formulation, Pulmaquin, is being tested in patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic lung infections with the bacteria P. aeruginosa, which leads to the enlargement of the lungs' airways.

The main goal of two latestage trials was to show an increase in the median time taken till the first instance of a pulmonary exacerbation (PE).

In one trial, called ORBIT3, Pulmaquin outperformed a placebo, but the results were not considered statistically significant, the company said.

Patients given Pulmaquin recorded a median time of 221 days till the first pulmonary exacerbation, while patients

46 EXPRESS PHARMA December 16-31, 2016

given a placebo took 136 days.

However in a second trial, ORBIT-4, Pulmaquin was deemed to have had a statistically significant benefit over placebo.

In this trial, patients given Pulmaquin recorded a median time of 230 days till the first pulmonary exacerbation, while patients given a placebo took 163 days.

There were eight deaths in the ORBIT-3 trial and six in the ORBIT-4 trial, but none of the deaths were related to Pulmaquin, Aradigm said.

Non-CF BE is a severe, chronic disease associated with high rates of mortality and has no approved treatment so far. It affects 150,000 people in the US and more than 200,000 in Europe.

The US Food and Drug Administration has given Pulmaquin an 'orphan drug' and a 'fast track' status, and has deemed the drug as a quali-

fied infectious disease product.

Pulmaquin contains a widely prescribed broadspectrum antibiotic called ciprofloxacin, which exists in oral and intravenous formulations to treat acute lung infections.

Aradigm's inhaled ciprofloxacin formulations, including Pulmaquin, are being evaluated to treat a plethora of respiratory diseases, including cystic fibrosis and non-tuberculous mycobacteria.

They are also being tested to prevent and treat bioterrorism infections such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and anthrax.

The Hayward, Californiabased Aradigm is also developing an inhaled treatment to deter smoking Reuters

autism in kids

Neither influenza infection nor vaccination during pregnancy were tied to children being diagnosed with ASD PREGNANT WOMEN who get the flu, or a flu vaccine, are not increasing their baby's risk for an autism spectrum disorder (ASD), a new study suggests.

Researchers analysed data on 196,929 children born from 2000 through 2010 in the Kaiser Permanente Northern California healthcare system after at least 24 weeks gestation.

During follow-up periods ranging from two to 15 years, 1.6 per cent of the children were diagnosed with ASD. Among the mothers of that 1.6 per cent, fewer than one per cent had the flu while pregnant, and about 23 per cent had gotten a flu vaccine.

Neither influenza infection nor vaccination during pregnancy were tied to children being diagnosed with ASD, the research team reports in JAMA Pediatrics.

"Our data showed pretty convincingly that there was no association with influenza at any time during pregnancy and autism in the child," said senior author Lisa Croen, of Kaiser Permanente Northern California in Oakland.

"We’re not recommending that any changes be made to the vaccination policy," Croen told Reuters Health. "We are encouraging women to get vaccinated while pregnant."

Previous studies looking at possible links between influenza during pregnancy and ASD had produced mixed results, Croen and her colleagues note in JAMA Pediatrics. And until now, they add, no studies had looked for links between ASD and flu vaccines, which are recommended for pregnant women.

People with ASD may have social, communication and behavioral challenges that may cause them to interact, learn and behave in ways different from most

people, according to the US Centers for Disease Control and Prevention (CDC).

A second study published in the same journal also found no link between vaccines against influenza A (H1N1) - sometimes referred to as swine flue - during pregnancy in 2009-2010 and complications later in life for over 60,000 Danish children.

The results support the overall safety profile of the vaccine, write the researchers, who were led by Anders Hviid, of the Statens Serum Institute in Copenhagen. They support the World Health Organization's recommendations that pregnant women should get a flu vaccine.

While the CDC recommends that everyone over 6 months of age receive a flu vaccine, it's especially important for some people including pregnant women - who are more likely to experience complications from the virus.

"The flu in pregnancy is dangerous," said Dr Loralei Thornburg, a high-risk pregnancy expert at the University of Rochester Medical Center in New York. "We know that women who have the flu do much worse and we know their babies do worse."

Pregnant women with influenza may be at an increased risk for premature labour and delivery, according to the CDC. There is also a greater risk of birth defects in their babies.

"There have been a lot of fears about vaccines, but the data suggest they are effective and don’t increase the risk of autism and other perinatal complications," said Thornburg, who was not involved with the new studies. "The benefits strongly outweigh any risks or theoretical risks that we’ve seen."

Reuters

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I N T E R V I E W

'Clearsynth intends to be the catalyst in accelerated discovery' Clearsynth is one of the global leaders in synthesis and supply of isotope labelled research chemicals.

Sakshi Sharma, Market Research Analyst, Clearsynth, reveals more about the company, in discussion with Sachin Jagdale Describe your services for the pharma industry ?

Clearsynth is a technologybased, research-driven organisation that specialises in developing certified analytical standards and high-end isotope research chemicals. The company is engaged in synthesis for stable, isotope-labelled compounds, metabolites, impurities, glucuronides, chiral compounds, conjugate impurities and radioactive labelled compounds. It is one of the few companies in India which deals with stable isotopes labelled compounds such as carbon-13, deuterium, nitrogen-15 and oxygen-18. The company is involved in supplying complex internal standards for mass spectroscopy LCMS use.

Clearsynth specialises in custom synthesis of reference standards, complex and ‘difficult to synthesise’, chemicals which are in compliance with global

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regulatory standards and high purity. At present, we are the world's largest inventory of deuterium compounds with around 2800+ internal standards and supplying it worldwide for LCMS use in PKPD studies.

take up contractual research projects, analytical services and FTE. All chemistry activities at Clearsynth are directed and led by Ph.D level organic scientist with combined 22+ years of experience in the pharma and biotechnology industry. The facility is well equipped with modern analytical instruments (NMR, GC, LC MSMS, IR/UV, TGA, DSC, Prep HPLC, flash chromatography) and is accredited with ISO 9001: 2008 (Quality Management System), ISO 14001 : 2004 (Environmental Management System) and OHSAS 18001: 2007 (Health & Safety Management System) standards.

Which are the challenges you face while dealing with the pharma sector?

Well, as pharma innovation is at peak, quality for products has become a major concern.

Consumers are becoming more aware for the significance of quality of the products. For every product we deliver, there is a demand for certificate of analysis and quality reports along with it.

Meanwhile, stringent FDA policies, regular audits at facilities and full adherence to GMP guidelines are major requirements that the company has to deal with.

How have pharma requirements changed over the years?

There has been a paradigm shift in the pharma industry.

Currently, quality of products is given utmost importance by all regulatory bodies. The consumer demands perfection in quality, reliability, low cost and timely performance.

There has been considerable increase in demand for sustainability in manufacturing as well.

Give details of your Hyderabad and Canada plants (products, capacity, staff, market they serve etc)?

Our state-of-the-art R&D centres are located in Hyderabad, India and Mississauga, Canada. â—— R&D Lab - Hyderabad Hyderabad: 100,000 sq ft The cGMP compliant R&D facility based at Hyderabad is operational since 2010. The site has its expertise in synthetic organic chemistry, offering custom synthesis services scaling from milligrams to kilograms, with over 200 chemical fume hoods. The lab is also open to

48 EXPRESS PHARMA December 16-31, 2016

There has been a paradigm shift in the pharma industry.

Currently, quality of products is given utmost importance by all regulatory bodies.

The consumer demands perfection in quality, reliability, low cost and timely performance

R&D Lab, Suite 1001 Mississauga, Canada Canada: 8,000 sq ft Clearsynth has newly expanded its R&D capabilities at Mississauga, Canada to serve the North American markets. The new state-ofthe-art R&D centre is in the forefront of Clearsynth’s efforts for a successful entry into advanced regulated markets. Clearsynth Canada is expected to strengthen our core business in custom and contract organic synthesis, mall and large molecule manufacturing, process development and undertake complex synthesis projects.

Clearsynth Canada is well equipped with modern analytical instruments and is expected to take up research assignments in the areas of contract research and manufacturing services.

Who are your pharma clients?

Presently, Clearsynth is serving over 3000 clients across 58 countries. Our major clients are Roche Diagnostics, Agilent Technologies (Instrumentation), Defence Research Organisation, Eurofins (Analytical), Anapharm, Glaskosmithkline (Drug Discovery), Teva (Active Pharma Ingredients), Syngenta Crop Protection

Munchwilen AG (Agrochemicals), and pharmacopeial institutes Besides pharma, which are the other industries you cater to?

Clearsynth offers its services to a broad spectrum of industries such as clinical research organisations, universities, research institutes, veterinary sciences, testing labs, forensics, agriculture, material sciences, defense, geology, hydrology, archaeology, microchips,semiconductor and others.

What percentage of your revenue comes from the pharma industry?

More than 70 per cent.

What is your market share in India as far as pharma business is concerned?

Approximately 70 per cent.

Since chemicals are major environment pollutants, what are your efforts to develop environment friendly processes and products?

All our products are developed through various treatment plant such as effluent plant. All the effluents are treated in our sewage treatment plant before disposal thereby ensuring we cause no harm to the environment. Clearsynth R&D facilities is accredited to Environmental Management System Certification ISO 14001-2004 which assures company to fall in line with significant environmental aspects.

What are your future plans?

Clearsynth intends to be the catalyst in accelerated discovery via synthesis of complex and difficult to make compounds. It aims to be the global leader in synthesis and supply of isotope labelled research chemicals. The company is also expanding its footprints in markets beyond North America and Europe. sachin.jagdale@expressindia.com

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‘India is an important market for manufacture and export of pharma products’ Bert Allard Jorritsma, Manager Special Cargo Product Service Delivery, Emirates, in an interaction with Sanjiv Das, talks about the recently launched Emirates SkyPharma and its services for Indian as well as the global pharma industry Emirates SkyCargo has recently launched Emirates SkyPharma. How will it enhance transport of temperature sensitive pharma shipments?

Emirates SkyPharma is Emirates SkyCargo’s complete solution to cargo customers who would like to transport their temperature sensitive pharma shipments.

We recently launched our purpose-built, state-of-theart facility at Dubai International Airport dedicated exclusively to the timely and secure transport of pharma products. With certification for EU Good Distribution Practices (GDP) from Bureau Veritas Germany, we adhere to most stringent guidelines and best practices for transportation of pharma products in our service, offering a high level of product integrity throughout the journey.

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For temperature sensitive pharma shipments, Emirates SkyPharma ensures: ◗ Controlled environments to avoid any temperature deviations from the required standards ◗ Segregated environments to avoid cross-contamination ◗ Highly secured operations ◗ Skilled technical staff to ensure adherence to outlined procedures at every step What are the facilities and transportation challenges?

Emirates SkyCargo has two state-of-the-art SkyPharma cargo facilities in Dubai- our freighter hub at Dubai World Central and our hub for cargo coming in on passenger flights at Dubai International Airport. We offer close to 8,600 sq m of combined handling space between the two terminals dedicated to handling pharma products.

The facilities are connected by a bonded and secured temperature- controlled road feeder service. In total, this is the largest facility anywhere in the world that has been certified for GDP. Our recently launched Emirates SkyPharma facility at Dubai International Airport has temperature controlled zones (2-8 0 celsius and 15-25 0 celsius), 88 temperature- controlled individual positions for the same temperature ranges in the automated ULD (aircraft pallet) handling system and seven (including the internal hub connection docks) temperature controlled acceptance and delivery truck docks.

Emirates SkyCargo therefore has the robust set-up needed for secure transport of pharma products. This involves minimising risk of contamination of medicinal products with other kind of products such as perishables.

Additionally, the medicinal products are stored in locations that are access controlled and monitored 24/7 by CCTV. This removes the risk of counterfeited products entering the supply

50 EXPRESS PHARMA December 16-31, 2016

We will progressively look at getting our facilities at certain pairs of origins and destinations certified for GDP and create the SkyPharma quality standard to ensure that we offer our customers end-to-end protection for pharma shipments during transport.

What makes your service unique from others? Who are your major clients in India and abroad?

In addition to our state-ofthe- art facilities at our hub, we have a modern fleet of over 245 wide body aircraft and a global network of over 150 destinations across 82 countries in six continents providing our customers with an unparalleled reach into markets across the world. We service the Indian market with multiple flight frequencies to nine Indian destinations including freighters.

We service the Indian market with multiple flight frequencies to nine Indian destinations including freighters

What stringent guidelines do you follow while shipping sensitive pharma products?

Emirates SkyCargo has analysed all relevant guidelines such as the World Health Organisation – and European Union guidelines.

On top of that, we take into account all relevant regulations from local authorities and we work according to IATA’s Perishable Cargo Regulations (PCR) and Temperature Control Regulations (TCR).

Based on feedback from our customers we have chosen to perform certification audits against EU GDP guidelines. Our certification is proof of our full compliance to EU Good Distribution Guidelines for

the handling of import, export and transit cargo shipments for pharma products at our Dubai hub.

What are your plans to tap the Indian pharma market?

How do you plan to optimise your network base in India?

India is an important market for the manufacture and export of pharma products.

Emirates SkyCargo works closely with our partners and customers in the Indian market to ensure timely and secure transport of their products to various destinations across our global network of over 150 destinations through our state of the art Emirates SkyPharma hub in Dubai.

Which are the areas that you serve? Tell us about your expansion plans.

Emirates SkyCargo is a global facilitator of trade and we connect customers across our global network of over 150 destinations. For pharma products, we will progressively look at getting our facilities at certain pairs of origins and destinations certified for GDP and create the SkyPharma quality standard to ensure that we offer our customers end-toend protection for pharma shipments. We will work with our stakeholders in these markets to eventually achieve this objective. sanjiv.das@expressindia.com

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VENDOR NEWS

Borosil Glass Works Limited registers standalone revenue of ` 119.6 crores EBITDA grew by 44.4 per cent during the period compared to H1FY16 BOROSIL GLASS Works Limited (BGWL) achieved standalone revenue of ` 119.6 crore recording a growth of 27.3 per cent during H1FY17 over the same period in the previous year. This performance was led by a very robust growth of 39.5 per cent in the Consumer Products Division (CPD) and a strong growth of 16.3 per cent in the Scientific & Industrial

Products Division (SIP). Earnings Before Interest, Tax, Depreciation and Amortization (EBITDA) grew by 44.4 per cent during the period compared to H1FY16. The company recorded improved margins as it benefitted from a higher scale of operations. Operational growth was accompanied by growth in investment income.

Net profit after tax grew from

To subscribe: bpd.subscription@expressindia.com

` 10.6 crore in H1FY16 to ` 20.6 crore in H1FY17, a growth of 94.5 per cent.

The Board of Directors of BGWL, Hopewell Tableware, Vyline Glass Works and Fennel Investment and Finance at their respective meetings held recently, approved a Scheme of Amalgamation of three related companies with BGWL in order to derive synergies by

bringing these entities under a single entity and pursue growth opportunities for the future. This move would also reduce the extent of related party transactions and eliminate cross holdings to simplify the group structure.

The scheme envisages the amalgamation of the following entities with BGWL: (1) Hopewell Tableware, a 100 per

cent subsidiary of BGWL, (2) Vyline Glass Works (Vyline), a promoter held company and (3) Fennel Investment And Finance, an associate company.

This will help to reduce operational cost and increase operational efficiency.

As per Shreevar Kheruka, MD, BGWL, “Our vision is to be the most customer-centric company in India. The

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company’s strategy of leveraging its strong brand and distribution channel by organic as well as inorganic expansion into new product categories has started resulting in attractive growth numbers. With a more simplified corporate structure, the implementation of GST around the corner and further operational improvements from growing scale expected in the next couple of years, both the divisions of the company are likely to benefit in the future with CPD and SIP expected to grow at over 15 per cent and 12 per cent respectively in the medium term.”

On January 29, 2016, the company acquired 100 per cent equity share in Hopewell Tableware, marketing its products under the brand ‘Larah’. With Larah, the company has gained participation in the fast grow-

ing opal glass market. During H1FY17, Larah recorded ` 44.6 crore sales as against sales of ` 48 crore during the full year FY16. The company’s strong pan-India distribution network, sales presence and channel loyalty has lent scale to Larah.

The company has also commenced a mass media marketing campaign and the initial response has been very encouraging.

On July 29, 2016, the company acquired 60.3 per cent equity share of Klasspack, a Nasik- based manufacturer of glass ampoules and tubular glass vials. Hitherto Borosil was marketing lab glassware to pharma companies for their research lab and quality control lab needs. With the addition of the Klasspack range to its portfolio, the company can now service the product manufac-

The company has used acquisition of synergistic businesses as a means to supplement organic growth turing glass packaging needs of its existing customers. During the two months up to September 30, 2016, Klasspack achieved revenue of ` 6.5 crore as against revenue of ` 28.8 cr during the full year in FY16.

The company’s revenue inclusive of Hopewell and Klasspack

during the period H1FY17 was ` 170.7 crore as compared to ` 93.9 crore during the same period in the previous year.

These figures are not comparable as the H1FY17 figure includes revenues of companies acquired post H1FY16.

The company has used acquisition of synergistic businesses as a means to supplement organic growth. Organic growth in both the business divisions has been achieved by improved sales in the existing range of products as well as the introduction of new products, thus selling more to the same set of customers. In CPD the new product range includes lunch boxes, storage products and kitchen appliances. These are expected to leverage the lifestyle changes towards convenience and improved presentation that the modern Indian

homemaker is looking for. The company sells its products through different channels including modern retail and traditional trade with the target segment being the aspirational middle class customer.

In SIP, the company introduced the brand ‘Labquest’, with a range of bench top instruments. In this division, the company’s diversified and large product range, international quality benchmarks and nationwide ‘Just In Time’ supply abilities ensure strong brand loyalty and high customer retention. In addition to the domestic market, where the company is the undisputed leader for glass consumables, it has also forayed into exporting its SIP range of products to the Middle Eastern, African and South East Asian markets.

EP News Bureau

HP India showcases labels and packaging advancements with HP Indigo WS6800 digital press Skanem Interlabels India chooses HP INDIGO WS6800 digital press to meet their growing digital printing needs HP INDIA recently showcased the HP Indigo WS6800 digital press including the recent labels and packaging advancements at Label Expo 2016. Also showcased were advanced automated colour management tools, new HP Indigo ElectroInks, upgrade packages, software enhancements for mass customisation amongst others. These new innovations allow more customers to capitalise on the growing digital opportunity in a market which is achieving double digit per cent page growth year over year. HP also announced the installation of HP Indigo WS6800 digital press at Skanem Interlabels India, at their Mumbai facility.

Sharing some of the success stories of key Indian brands who have innovated in labels and packaging with HP’s Indigo technology, A Appadurai,

52

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Country Manager, Indigo and Inkjet Web Press, Graphics Solutions Business, HP India said, “The consumer market is changing rapidly with proliferation of products, which leads to shorter and shorter run lengths. A research report from POPAI indicates that 76 per cent of retail purchases are made at the store. This brings a battle of brands to the shelf of a super market. The packaging of the product should enable the brand to stand out of the shelf. Packaging decoration and functionality can be tremendously improved by digital packaging. On demand packaging is turning out to be a great saviour for brands that needs faster time to market and to differentiate from the growing competition. These three factors are the basic reasons for the huge increase in

The new innovations will allow more customers to capitalise on the growing digital opportunity in a market the demand of digital printing.

We are seeing the digital printed labels and packaging growing at a very high pace and our customer base in India is executing more and more innovative projects.”

On second day of the Label

Expo 2016, HP announced the installation of the HP Indigo WS6800 digital press at Skanem Interlabels India – one of India’s leading labels and packaging converters; at its Mumbai facility. Skanem Interlabels India is a repeat customer of HP and installed the first HP Indigo press–HP Indigo WS4500 digital press in 2011. To address the mounting pressure and the need to meet the growing volume, Skanem Interlabels India decided to install HP Indigo WS6800 digital press HP’s flagship solution for labels and packaging applications, further strengthening their trust and partnership on HP Indigo digital printing technology.

Sharing his thoughts on the installation, H Venkataraman, MD, Skanem Interlabels India said, “Skanem Interlabels has been the pioneer in adopting

the HP Indigo technology for producing self-adhesive labels and building a successful business model around the Indigo technology. The HP Indigo WS6800 digital press boosts our capacity and at the same time improves efficiency with inline priming and spectrophotometer. We believe that the HP Indigo WS6800 digital press will enable us to offer a tremendous brand development opportunity for our customers while also helping us increase the production capacity to cater to a larger set of customers. We would also like to thank HP for the support provided to us throughout this journey, working as a close partner to make our business successful. This is one of the key reasons for us to repose our faith in HP.” EP News Bureau

IPC SPECIAL

One Brand Total Solution

Cyro International acquires PDP Couriers Customers will be offered innovative and customised temperature-controlled logistics solutions CRYO INTERNATIONAL, an Air Liquide group subsidiary specialising in temperaturecontrolled logistics solutions, has just acquired PDP Couriers, a major player in the customised transport of high value added products for the pharmaceutical and biotechnology industries.

Based in the UK, PDP Couriers has over 120 employees at 14 locations worldwide. The company generated revenues of approximately €21 million in 2015.

PDP Couriers has grown significantly in Eastern Europe, Latin America and Asia over the past

This acquisition is a new phase in the strategy initiated in the past few years

by CRYO International few years.

Safety, punctuality and reliability are key in the transport sector for temperature-sensitive samples and products in the pharma industry, particularly in the clinical research area. PDP Couriers is one of the specialists in this sector with an international presence.

This acquisition is a new phase in the strategy initiated in the past few years by CRYO International, whose goal is to be able to offer its customers innovative and customised temperature-controlled logistics solutions anywhere in the world.

Guy Salzgeber, Senior VP, Europe Industries, and a member of the Air Liquide group’s Executive Committee, commented, “Cryo International illustrates the Group’s intention to seize growth opportunities in adjacent markets. The acquisition of PDP Couriers is very

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much in line with this approach.

We are delighted to welcome these new employees to Air Liq-

uide.”

Cédric Picaud, CEO, CRYO International, added, “With this

acquisition we are combining our know-how in CARBOGLACETM and tempera-

ture-controlled solutions with a premium logistics service.

EP News Bureau

IPC SPECIAL One Brand Total Solution

Avantor unveils new brand identity Corporate logo and brand identity reflect Avantor’s position as a growing, global supplier of highpurity life sciences and advanced technologies materials AVANTOR PERFORMANCE Materials, introduced a new corporate logo and visual identity today. The change comes two months after Avantor merged with NuSil Technology to form a growing, global supplier of ultrahigh-purity life sciences and advanced technologies materials with strict regulatory and performance specifications.

“Following the merger of Avantor and NuSil Technology, we needed to give our company a fresh look that reflects our corporate evolution and global footprint,” said Michael Stubblefield, CEO, Avantor. “With input from customers and other key stakeholders, we developed a logo and corporate identity that aligns with the value we of-

fer our global customers.”

The most striking element of the new corporate logo is a symbol called the “petals of life,” which flows from the corporate name and is a direct homage to Avantor’s focus on collaborative innovation and working with customers to solve their business challenges at any scale.

“Avantor is known for our unique approach to identifying and solving the specific busi-

ness and operational challenges faced by our global customers,” continued Stubblefield. “We develop custom solutions and connect customers with the right, highquality products to meet their unique needs. Our new corporate logo is emblematic of this collaborative approach to innovation and problem-solving.”

Avantor provides performance materials and solutions for the production and re-

The new corporate logo will be rolled out methodically over the coming months on all company platforms search needs of more than 6,500 customers across the biotechnology, pharmaceutical,

medical device, diagnostics, aerospace and defence, and semi-conductor industries. The company offers a portfolio of more than 30,000 products that meet increasingly stringent standards across technology-driven and highly-regulated markets.

The new corporate logo will be rolled out methodically over the coming months on all company platforms, including facility signage, web properties, promotional materials, product labels and documentation. The change to the corporate logo will have no impact whatsoever on product quality or specifications, product availability or service delivery performance.

EP News Bureau

Aptar Pharma nears completion of elastomer component capacity in North America The space will house state-of-the-art clean rooms and integrated best-in-class vision equipment APTAR PHARMA, a leading provider of drug delivery systems, is nearing completion of its expansion at its Congers, NY state-of-the-art manufacturing site. The new space will enable the company to better serve North American pharmaceutical customers, as injectable elastomeric component manufacturing will be completed in the US for the first time by Aptar.

Final construction is planned by the end of the first quarter of 2017 so that Aptar Pharma can anticipate shipping validation batches to customers in the second quarter of next year. The expansion is part of a stepped programme to increase Aptar Pharma’s footprint in the US, according

54 EXPRESS PHARMA December 16-31, 2016

to Bas Van Buijtenen, President of the Injectables Division of Aptar Pharma.

“This investment is continuing our commitment to growing and accelerating our footprint in North America. More significantly, the technology we are introducing will increase our abil-

ity to provide world-class manufacturing capabilities to our customers locally. This will provide premium products, shorter lead-times and more responsive service for the US elastomeric components markets,” Van Buijtenen said.

The added space will house

state-of-the-art clean rooms and integrated best-in-class vision equipment, according to Van Buijtenen. “Vision equipment will be used to perform 100 per cent of the automatic inspection of all parts during the finishing process to ensure Premium Vision product quality,” he said. “The increased facility space also enables the company to conduct all of our finishing operations in the US, including Aptar Pharma’s recently launched Premium Coat coated stoppers.”

The expansion was necessary to meet the continued growth of Aptar Pharma’s US injectables business and is part of Aptar’s multiyear investment programme supporting the global growth of its injecta-

bles business. “We are bringing all of our knowledge and the value-adding parts of our process closer to the customer,” he added. “We want our customers to know us better.

To understand what we can do for them on an entirely different level.”

Van Buijtenen also commented, “We are a global player with a strong position in North America. Our integration into Aptar Group gives us access to the latest technologies, exceptional people and great financial stability. Our US business has been growing very rapidly, and this investment in capacity will support and accelerate our growth into the future,” he said.

EP News Bureau

IPC SPECIAL One Brand Total Solution

Merck collaborates with Evotec Accelerates screening of customised CRISPR and shRNA libraries MERCK HAS entered into a set of agreements with Evotec, whereby Evotec will provide screening services for Merck’s collection of genetic reagents such as CRISPR and shRNA libraries. Combining access to these libraries with Evotec’s screening expertise offers an accelerated pathway to explore and identify new drug targets.

“Drug discovery starts with

the identification of new targets, a process that can be time- and labour-intensive,” said Theresa Creasey, Head of Applied Solutions Strategic Marketing & Innovation, Life Science. “Our collaboration with Evotec accelerates the discovery workflow, enabling customers to more rapidly and efficiently explore disease pathways and find new targets.”

The collaboration allows customers to select a customised set of CRISPR and shRNA libraries, and then leverage Evotec’s extensive capabilities in phenotypic screening within primary and induced pluripotent stem cells and in vivo disease models. The target identification workflow is further accelerated through the use of custom engineered cell lines developed by Merck’s Cell Design Studio.

These cell lines are used by Evotec to customise screening assays and deliver answers more efficiently.

“This agreement with Merck further strengthens our offering in the area of target identification and validation,” said Mario Polywka, COO, Evotec. “Deploying Merck’s assay-ready reagents on our cellular screening platforms and in vivo models creates powerful drug discovery capabilities and more value to

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our customers through such a comprehensive solution.”

Merck partners with the

Wellcome Trust Sanger Institute for its arrayed CRISPR library covering the entire human

genome. The company is also the manufacturer and distributor of the world’s largest RNAi clone li-

brary, created in collaboration with The RNAi Consortium.

EP News Bureau

IPC SPECIAL One Brand Total Solution

PRODUCTS

Skytech Systems launches online TOC analysers THERE WERE days when taking a water sample once in a day from the PW/WFI distribution loop and analysing it at the lab would satisfy the auditors about water quality. But, nowadays the expectation of auditors is increasing and they expect online monitoring of the PW/WFI loop with higher sample frequency to ensure that quality is being monitored.

Although the frequency of the online monitoring is not mentioned, based on risk calculations we can fix the minimum frequency of monitoring. It could be anywhere between 15 minutes to one hour, based on the capacity of generation, user points consumption, storage tank etc.

Once the online analyser is being installed in line it gives some total organic carbon (TOC) data which needs to be validated and co-related to offline measurements. In the market there are two online TOC measurement systems available: Sensors (fast, less accurate, less stable) and Analysers (slow, more accurate, more stable). Most of the online analysers (95 per cent) used in UPW applications is conductivity based as it has proven to be most suitable for these applications. The detector can be a direct conductivity, membrane conductivity or dynamic end point detection by single sensor differential conductivity methods. As the direct conductivity method is more of a sensing technology it needs more calibration, possibly every six months. Whereas the membrane conductivity and the dynamic endpoint detection by single sensor differential conductivity methods are more stable with a calibration stability of one year.

Calibration of TOC analyser used in UPW water is known to be critical due to its low level of detection (4ppb-500ppb). It has some significance based on

56 EXPRESS PHARMA December 16-31, 2016

between 85 per cent to 115 per cent, then it passes this test.

RE = 100 [(rss–rw) / (rS–rw)].

Procedure

which technology you are using and how stable it is. As far as compendial requirement for Pharmacopeia is concerned, the TOC analyser used in pharma manufacturing process should be tested and challenged with System Suitability Test (SST) to ensure the unit is between the required specification range (85 per cent = RE =115 per cent). The frequency of SST again depends on the risk analysis of the technology used to measure the capability of the water system to deliver stable quality of water. These tests are offline tests and need to be done with external standards. Calibration of the system is key for a good response from the instrument with high degree of accuracy.

And during calibration, the system made to correct itself to the standard value.

Calibration procedure We need standards for calibrating a TOC analyser. These standards are made from chemicals like sucrose or Potassium Hydrogen Phthalate (KHP). Sucrose is a very common chemical where as KHP is a more stable compound. These chemicals are diluted with a specific dilution ratio to achieve a particular concentration. It is always good to have the multipoint calibration method to ensure that

the system is in perfect line. The points can be chosen between operating range and analyser range. A typical concentration used for calibrating the online TOC is 250 ppb, 500ppb, 750 ppb and blank. These concentration as carbon can be made easily in the QC laboratories by using sucrose. However, we recommend using NIST traceable readymade standards as this affects the TOC value during routine analysis.

Some analysers have in-built offline sampling and some do not. Those that do not have an offline sampling system need to attach a separate module called calibration KIT. Mostly high end analysers will have the option of offline sampling then you can directly introduce the standards one by one so that calibration can be done. There are certain analysers available which have multiple offline PORT so that all the standards can be introduced at once to perform a fully automatic calibration. The analyser runs the standards one by one and calculates the drifts with the internal algorithm and stores it in the calibration parameter.

At the end of the calibration process the analyser will ask either to accept the new calibration constant or reject it, if you accept it, take the new calibration constants and replace it

with older one, if you reject the test then it keeps the older constants only.

It is always advisable to run validation/verification standards of known concentration and check the response with new calibration constants after calibration. Once it is an accepted criteria then the analyser should be taken forward to the next step. If not, calibration should be repeated.

System Suitability Test (SST) This is a compendial requirement of Pharmacopeia. TOC is a non-specific method but there are many other technologies available which can be used in the detection of the same.

Rather than qualifying all the technology individually, Pharmacopeia has made this test mandatory to not only qualify the technology or instrument but also to validate the analysed samples.

This test is done to challenge the capability of the analytical method used for TOC analysis by testing it against the easiest and hardest (difficult) oxidised chemicals. Prepare a 500ppb as C of standards by using sucrose and 1-4 Benzoquinone and by getting it analysed. Then, get the response efficiency calculated from the analysed values of the above standards. If it falls

◗ Using ultra pure water, prepare standards of 500ppb as C by adding sucrose and 1-4 Benzoquinone by proper dilution. ◗ First, analyse the blank water and denote the result as Rw ◗ Next, analyse the sucrose standards and denote the result as Rs ◗ Then, analyse the 1-4 Benzoquinone standards and denote the result as Rss ◗ Manually calculate the RE with above formula and ensure it falls in between 85 per cent to 115 per cent. ◗ The SST results of the analyser certify intactness of the analytical methodology and also certify that the components present in the analyser are working satisfactory. At the same time, this also validates the result produced in past.

As these standards have to be introduced to the analyser, a smart online TOC analyser should have an offline sample introduction system in built or it needs to be arranged externally in case of economic TOC analysers. All the calculations are in-built. Most of the tests need multiple standards, for example; multipoint calibration needs four vials, SST needs three vials, accuracy needs four vials etc.

There are certain analysers available in which you can introduce all the vials at a time and can run a fully automatic calibration/SST/validation.

Contact Prachi Thakare Skytech Systems (India) 401, Siddheshwar Arcade, Opp Suraj Water Park, Off Ghodbunder Road, Thane (W) - 400615 Tel: +91-22-4153 3342 Fax: +91-22-4153 3388 Website: www.skytechindia.com

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Weber Marking Systems introduces XB4JET THE XB4JET of Weber Marking Systems is a controller which can drive ink jet print heads for product identification. The XB4JET can control both thermal and piezoelectric print heads.

The XB4JET permit a wide range of print images on products, i.e. product descriptions, graphics, quantities,

Technical specifications Dimensions (H x W x D in mm) 110 x 176 x 180

input, 2D barcodes, 2m print length, data backup with USBStick, interface functions, data base connection.

Weight

2570g

Power Connection

90-240 VAC / 50-60Hz (1~)

Power Consumption

max. 100 W

Protection class:

IP 40

Environmental Conditions

10-90 % relative air humidity (non condensing)

Environmental Temperature

5 – 40°C

Interface

Ethernet, EIA232, USB A, USB B

Connections

4x Printhead, 2x Sensor, 2x Encoder, 2x Alarm,

Cable length

Powercable 2m,Printhead 3m,Max.: HP 13m,LX 50m,MX 50m

Layout creation

iDesign / iDesign Touch

Parameter changing

iDesign / iDesign Touch

Print height

HP, LX: 12,5 up to 50mm, MX: 50 up to 400mm

Resolution

50 – 900dpi horizontal HP, LX: 300/600dpi, MX: 192dpi

Memory

2Gb, expandable

Automatic functions

Date,Time, Counter,Variable, Kustomer specific links

Bar- und 2D-Codes

EAN 8, EAN 13, EAN 128, 2/5 ITF, 2/5 mit Prüfsumme Code 128, UPC A, UPC E GS1-Datamatrix, Datamatrix, QR-Code

Operating time

Continous

Functions XB4JET Pro Like XB4JET Advanced extra it provides Hi-Speed adjustable with print speed up to 240 m/min with 300 dpi, up to 6m text length, password protection, DB-Print software.

The XB4JET control systems will be delivered as advanced version standard. If the requirements exceed the scope of services of the advanced version, an upgrade with costs to the Pro version is available. best before dates, barcodes and serial number.

Print layouts can be created with the included iDesign software and can send via network connection or USB interface or USB stick to the XB4JET.

Functions of XB4JET Advanced Print speed up to 90m/min with 300dpi, counter, date with best before, variable

Contact Office No.11, “GIRNAR”, S. V. Road, Opp Police Station, Dahisar(E), Mumbai - 400 068. India.

Mob: +91 9820509630/+91 7738536663 Email:sales1@markvitrack.com, info@markvitrac.com

WORLD CLASS LAB FURNITURE Operating in India for almost a decade now, Simfa is the exclusive dealer of laboratory furniture and fume hoods from Mott Manufacturing Ltd - Canada and Laborbau Systeme Hemling GmbH - Germany in India.

Complementing the product offerings, we are equipped with a strong designing team, experienced project managers and boast of clients of repute like US Pharmacopeia, Dupont, GVK Bioscience, Laurus Labs to name a few.

International products, meticulous planning, flawless designing and ruthless execution are the cornerstones of any project for us. Experience us and you will say ‘truly world class’!

SIMFA SCIENTIFIC SUPPLIES PVT. LTD. #206, Ashoka Chandra Enclave, Red Hills, Lakdi Ka Pul, Hyderabad - 500 004.

T: 8099-77-1111. E: sales@simfascientific.com

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Kleantech Engineering Systems launches largest manufacturing for cleanroom technology Kleantech has in-house capability for designing and executing any size of projects in a short period KLEANTECH Engineering Systems, established in 2008, is a fully stabilised company and has completed 100 pharma projects for formulation, bulk drugs and API, etc.

It has also executed projects for electronic industries, food industries, etc. Kleantech has an in-house capability for designing and executing any size of projects in a short period.

Kleantech Engineering Systems has recently launched India’s largest manufacturing unit for turnkey air conditioning, refrigeration, ventilation and bio-cleanroom applications in Karnataka, 110 kms from Hyderabad International Airport.

The company is into the manufacturing of cleanroom equipment and all types of cleanrooms, sandwiched type of prefabricated panels, doors, air handling units, Dx units, cold storage, SS cleanroom furnitures, electrical control panels, HEPA Filters and pre filters, fine filters, microvee- filters. All equipment and accessories are made in the factory and since there is no relying on other suppliers, hence the execution of project becomes more faster.

The company is also instrumental in providing services for cleanrooms. The products and services meet the requirements of food, pharmaceutical and electronic industries.

Further, it also provides turnkey solutions for clean room applications at its current manufacturing units, located at Vasai (E) Palghar (Maharashtra) and Karnataka.

The company is also into designing and commissioning of cleanroom HVAC projects, modular clean room systems for pharma and other allied

58 EXPRESS PHARMA December 16-31, 2016

industries. Backed by a team of professionals, Kleantech Engineering Systems also assist or clients in the preparation of facility layout and process equipment validation.

Support of diligent professionals and high-tech amenities help to provide most reliable solution to its clients.

Currently, the company has an annual turnover of ` 40-50 crores and it is expecting a 50 per cent growth in 2016-2017. The products and services are reliable and are availed by electronic, food and pharma industries. Kleantech Engineering Systems is a client-centric organisation.

Kleantech Engineering Systems has a large network of clients in India and abroad.

Apart from India, its clients are located in North Africa, East/Middle Africa, South/ West Africa, the Middle East and South America. Due to a continuous support of its professionals, the company

Kleantech Engineering Systems has a large network of clients in India and abroad. Apart from India, its clients are located in North Africa, East/Middle Africa, South/ West Africa, the Middle East and South America is expecting an exponential growth in the near future.

The manufacturing units have large production capacity and helps in meeting the bulk requirements of its clients.

Today, the cleanroom technology and HVAC and its built products have witnessed an increasing and continuous growth all over the world.

Contact Kleantech Engineering Systems, Tel: +91 0250 2458869 / 2458870 Mob: +91 97642 81212 / 90048 35550 E mail: info@kleantecheng.com kleantech08@yahoo.com www.kleantecheng.com

IPC SPECIAL One Brand Total Solution

Goodwill Retails launches FiberFix GOODWILL RETAILS has launched FiberFix, which will fix an array of problems ranging from fixing pipes to broken hardware. FiberFix uses industrial grade fibre and resin to repair and fix products from mixed media that will bond to almost anything, hardens like steel, and provides a permanent fix. It is also more than a 100x stronger than duct tape. Using FiberFix, consumers can fix things that either could not be fixed before or could not be fixed inexpensively.

Spearheaded by Spencer Quinn and Eric Child, FiberFix was started in late

2012, post which, they entered Shark Tank. Backed by Lori Grenier, they found the funding they were looking for, after proving the concept of this ground-breaking product. It is now a household name in the US and it is Goodwill Retails’ endeavour to make it so in India.

With its wide base of application, it can be used in both industrial and residential settings. A number of industries can benefit from its usage as it fixes motor pipes, water pipes, high pressure pipes, vehicle parts, breaks in machine parts, garner hoses, etc. The beauty of the product lies in the fact that, if kept at hand, it can drastically reduce down time in industrial settings, not only saving money, but also resulting in productivity and efficiency. In household settings, it can help fix furniture, utensils,

tools, pipes- the opportunities are unlimited, metal and wood alike.

Simple to use, FiberFix involves sanding the affected area, dipping the wrap in water for 5-10 seconds, wrapping the product to the affected area and applying the vinyl strip to tighten the wrap. Being self-adhesive, no other products are required in the process of using FiberFix. It uses a combination of fibre and resin to have a steel-like grip on the affected area, securing your assets. It takes about 2-5 minutes to use, cutting down downtime dramatically. It is waterproof, making its application widespread and is resistant to heat and cold, so it is perfect to fix industrial breaks in machinery and hardware. The product is resistant to climatic changes and is a longterm solution for a number of problems that are faced both by industries and households.

It comes in two variants- the wrap and the patch. The wrap is available in four sizes –1”x12”, 1”x40”, 2”x50”, 4”x60”. Each roll is considered a single use item. Each roll comes in an air-sealed pouch. Once this pouch is opened, the wrap needs to be used right away. Each roll comes with a pair of gloves, which adds convenience in working with FiberFix. The patch comes in three sizes- 3”x3”, 2”x8” and 5”x5”.

FiberFix is present in over 24 countries and now this game changing product is in India. With ample advantages and features, every household and industrial setting can benefit from having this product readily at hand.

Contact details HK Jain Director GoodWill Retails 9619997115/3115 fiberfixindia@hotmail.com goodwillretailspvtltd@hotmail.com

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IPC SPECIAL One Brand Total Solution

BOGE KOMPRESSOREN introduces energy-efficient pipe systems BOGE KOMPRESSOREN has expanded its portfolio by one of the most energy-efficient pipe systems available on the market.

BOGE Compressors India based in Chennai is a subsidiary of BOGE KOMPRESSOREN. In contrast to conventionally implemented steel systems, the aluminium pipes and fittings are permanently protected against corrosion. The advantage when compared to plastic pipes is that they are resistant to UV radiation. In addition, AIRficient can withstand temperatures of between -30°C and +80°C. Even under the most adverse conditions, this solution thus guarantees the efficient transfer of compressed air, nitrogen and vacuums. Users benefit from durable pipes, a high degree of investment certainty and save up to thirty per cent on their total costs.

BOGE aluminium pipes meet the highest customer requirements providing stable flow rates and clean compressed air.

The REACH- and RoHS-compliant pipes and fittings have a special coating guaranteeing a long service life. With a temperature

AIRficient aluminium fitting

AIRficient pipe system in use

resistance of between -30°C and +80°C at an operating pressure of up to 16 bar, AIRficient is more heat-resistant than pipe systems made of aluminium that are supplied by competitors.

BOGE provides a ten-year guarantee on material defects.

Energy flow In comparison to standard sys-

60 EXPRESS PHARMA December 16-31, 2016

tems, the BOGE system is easier and more efficient to install.

Clamping ring fittings connect the pipes on the surface. This ensures that any narrowing, that occurs on conventional, pressed pipe connections, is avoided and any loss of pressure is completely ruled out.

The special coating prevents oxidation, which can conse-

quently cause serious corrosive material damage to standard copper and steel pipes. The system is also free of oil and silicone. By implementing the BOGE system, users increase energy efficiency and reduce the total costs by up to 30 per cent.

AIRficient is compatible with all BOGE products. It can

be used for oil-free and oil-lubricated applications in the compressed air sector. It is also suitable for transferring inert gases, such as nitrogen.

When transferring vacuums, AIRficient can withstand a pressure of up to 13 mbar, while galvanised steel pipes can only reach 300 mbar.

Contact details BOGE India #216, Third Link Street Nehru Nagar Industrial Area, Kottivakkam, Chennai – 600041 Franklin Comforter Jayakaran, Country Manager Telephone: +91 44 4359 3454 Fax: +91 44 4359 3452 E-mail: fc.jayakaran@boge.com www.boge.com/en

IPC SPECIAL

One Brand Total Solution

Clean room high speed doors

by Gandhi Automations

GANDHI AUTOMATIONS provides clean room high speed doors. The doors are best suited for facilities where you need controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility.

High speed clean room doors designed by Gandhi Automation are engineered carefully with the following features below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent

PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h ? 50 PA. ◗ Control device enclosure in Stainless Steel SS 316 Contact Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West), Mumbai - 400064 Phone: +91-22-66720200 / 66720300 (200 lines)

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IPC SPECIAL One Brand Total Solution

Development of a novel cold-chain tubing, FP-FLEXand single-use freezing bag WORKING CELL banks (WCBs) are commonly applied to initiate cell culture manufacturing campaigns to produce therapeutic proteins.

Those campaigns typically begin with the inoculation of cells previously cryopreserved in vials. Although vials are typically used to establish WCBs and initiate manufacturing campaigns, they are not optimal for the growing demands of commercial production.

Vials are small, and filling and removal of their contents are performed through an open cap. That process leads to numerous manual operations and culture vessels, resulting in contamination risks and potential campaignto-campaign variability.

Single-use bags would be ideal for WCB applications, but adoption has not been observed because currently available bags and tubing don’t hold up to the demands (e.g., they break and/or can’t be welded) when stored and transported at cryogenic (-196ºC) temperatures.

To overcome such challenges, novel thermoplastic tubing was developed to balance both the flexibility and robustness demands of cryogenic storage and tube welding characteristics necessary for sterile closedsystem processing. The new FP-FLEX tubing can be frozen and maintained at cryogenic temperatures, thawed, and sterile welded to other thermoplastic tubing (such as C-Flex tubing).

Material and methods Studies were designed and performed to assess durability and functional utility of the new FP-FLEX tubing for frozen storage and processing

62 EXPRESS PHARMA December 16-31, 2016

applications. A novel manufacturing method also was developed to enable unitised welding of FP-FLEX tubing directly to Freeze-Pak bags.

Handling and transportation testing Testing was carried out using 500 mL bags with either FPFLEX tubing or PVC tubing (standard). Bags were filled to

140 ml (±5 ml) with water, placed into storage cassettes and frozen in LN2 (-196ºC) with tubing attached. For the handling test bags were pulled from liquid nitrogen (LN2)

storage, immediately dropped horizontally 4X from 1 ft., thawed and evaluated. Ten of 10 bags with FP-FLEX were completely intact, whereas 10 of 10 bags with PVC tubing

IPC SPECIAL One Brand Total Solution

Studies were designed and performed to assess durability and functional utility of the new FP-FLEX tubing for frozen storage and processing applications.

A novel manufacturing method also was developed to enable unitised welding of FP-FLEX tubing directly to Freeze-Pak bags were broken. A single drop from 2 ft resulted in similar results. For the transportation test, bags (in cassettes) were placed in LN2 shippers followed by simulated ASTM transportation testing. After testing, bags were removed, thawed, and evaluated for damage.

Welding/Functional testing To evaluate sterile welding capabilit ies of FP-FLEX tubing postthaw, tubing was frozen, thawed, and welded to C-Flex tubing. Testing included integrity, flow rate, and weld strength. Tubing was capable of welding directly to C-Flex tubing using standard sterile welders with flow rates up to 1L/min achieved successfully.

Summary Freeze, Thaw, Weld: Making The Cold Chain Link WCBs are commonly used for seed-train manufacturing of therapeutic products. Traditional vials represent an open manufacturing process and are also limited to small volumes, which contribute to lengthened production campaigns.

The new FP-FLEX tubing has been designed and shown herein to meet the critical processing requirements for WCBs, including: ◗ Freezing/storage/transport to as low as -196ºC ◗ Weldable to C-Flex postfreeze/thaw ◗ Compatible with standard tube welding and sealing devices ◗ Closed-system aseptic transfer through tube-to-tube connection.

FP-FLEX tubing and Freeze-Pak Bag represent a closed-system solution, enabling frozen storage, sterile connection, and reduced scale-up time for therapeutic production.

Charter Medical have a 25 year history of developing and providing specialty single-use products to the

blood transfusion, cell therapy, biotechnology and pharma markets.

Their 15,000 sq ft of clean room space located in Winston-Salem, NC, USA is ISO 13485 certified and FDA registered. Focus is on designing and supplying single-use solutions for cell growth, frozen storage and biological fluid handling. Charter Medical is committed to providing quality products and services with and experienced staff dedicated to exceeding customer expectations from product development, delivery and implementation. Partnering with Shah Brothers, Charter Medical wishes to offer the latest path breaking products and customised single use solutions for the Indian market.

(This article has been authored by Dominic Clarke, Global Product Manager for Bioprocessing and Cellular Therapy.

For any queries please write to pharma@shahbros.com)

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Neelikon upgrades its laboratories NEELIKON HAS recently made improvements at its factory in Dhatav, near Mumbai.

They are: ◗ Customer support laboratory – To assist customers with their formulation request, Neelikon has added a customer laboratory of ap-

prox. 2000 square feet with additional emphasis to make colour cosmetic products inhouse like foundation, concealer, lipstick, lip gloss, eye liner, mascara etc. ◗ Instrumentation laboratory – Neelikon has added further two High Performance Liquid

Chromatography (HPLC), one Inductively Coupled Plasma Optical Emission Spectrometer (ICP-OES) and 1 Gas Chromatography (GC)to its existing instrumentation laboratory in keeping with increasing sales of the legislated colours for cosmetics, pharma and food.

◗ New blending and processing plant – The company has built up a new blending and processing unit as per cGMP requirement with clean air system with air control of 100000 units to support business of value added colours like blends, dispersions etc.

Customer support laboratory

New blending and processing plant

64 EXPRESS PHARMA December 16-31, 2016

Instrumentation laboratory

Contact Neelikon Food Dyes And Chemicals D-8, Everest, 5th Floor, Pandit MM Malaviya Marg, Tardeo Circle, Mumbai 400 034 Email: info@neelikon.com

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I N T E R V I E W

â&#x20AC;&#x2DC;We recorded a growth of around 15% last fiscalâ&#x20AC;&#x2122; Ritvik V Saraf, MD, REMI Group, speaks about his company's offerings for the pharma sector and its growth plans, in an interaction with Express Pharma Give us an overview about REMI Laboratory Instruments and its growth REMI is a well-known brand with the scientific and healthcare community in India for more than 50 years. It is a pioneer in supplying innovative products that are import substitutes thereby helping the nation save precious foreign exchange. We were the first in India to manufacture table top centrifuges, laboratory and magnetic stirrers, high speed (20000 RPM) centrifuges, refrigerated centrifuges, blood bank centrifuge for component separation, CE marking for table top centrifuges, mixers and shakers and biggest top entry agitator in India for fluid mixing.

REMI has been exporting its products to more than 50 countries globally. We participate in international exhibitions and trade shows to increase our presence and keep ourselves abreast with the changing technology, customer requirements and new product introductions.

How has REMI Laboratory Instruments contributed in the growth/success story of the Indian pharma industry?

The Indian pharma sector is expected to reach $20 billion in 2015 -2016, In order to facilitate such an exponential growth, the pharma sector needs constant supply of state of the art products which are technologically advanced and quality driven. REMI has been catering to the pharma industry for over 50 years; we always strive to be at par with global standards with respect to technology, ingenuity and innovation. Whether it be testing, storing, freezing or mixing, our products are reliable and help pharma companies go about their daily operations smoothly and efficiently.

What are the advantages of your

products? How good are they in comparison with your competitors?

REMI are pioneers in the laboratory and healthcare industry. Our products are reliable, safe, user friendly and performance oriented. We, at REMI, believe in our core values of providing quality products to our customers, we leave no stone unturned in designing, manufacturing and delivering quality products to our customers.

How much revenue did your company generate in the last fiscal? What percentage of your revenue came from the Indian market?

REMI is constantly growing and improving year by year. We recorded a growth of around 15 per cent last fiscal and we expect to grow even more next year. Our habit of improving our products without compromising on quality is what sets us apart and helps us increase our revenue.

We have upgraded our product range this year with new and innovative products. We have also recently launched REMI Healthcare Division.

The healthcare division will primarily focus on providing quality products to diagnostics centres, pathology labs, blood banks hospitals, clinical and medical research institutions etc.

EP News Bureau

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The United Engineering Company: Serving the pharma industry for the last five decades THE UNITED ENGINEERING COMPANY (UEC) with the brand name ‘UNITED’ is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in the year 1963 by GD Roy, has attained high reputation in providing machines and services of highest standards since the beginning. With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

UEC, which was started in the year 1963

by GD Roy, has attained high reputation in providing machines and services of highest standards since the beginning EXPRESS PHARMA

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IPC SPECIAL/WEST BENGAL PHARMA REVIEW One Brand Total Solution

The company has also expanded its footprints abroad in a large way. Today, ‘UNITED’ machines are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, the UAE, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘UNITED’ machines provide technically advanced solution for its customers.

Presently UEC is having its head office in Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having its marketing and sales office in Mumbai to cater to the eastern part of the nation and overseas. The company has also set up well equipped service shop in Mumbai to service its clients.

The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development and continuous value additions to the pharma packaging industry.

Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focused on being a corporate citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events which help in uplifting the quality of living of the deprived.

With almost every pharma formulation manufacturer being an ‘UNITED’ machine user coupled with 50 years experience, UEC commits in becoming better than the best in the near future.

Founder: GD Roy (R)

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

68 EXPRESS PHARMA December 16-31, 2016

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NEOMACHINE MFG CO: Aleader in automatic coating technology KOLKATA-BASED NEOMACHINE MFG CO was started in 1973 with an objective of manufacturing quality pharmaceutical machinery. For a decade, the company catered to the requirements of the Indian pharma companies in injectable, liquid, tablet, capsule and ointment sections machinery.

While catering to this market segment, NEOMACHINE happened to come across a Kolkata-based pharmaceutical producer, who were envisaging problems in film coating of tablets. Till then, the tablets were being coated in conventional pans, which were not only

causing health hazards to the coating personnel, but was also a time-consuming process. Inspired by this opportunity, NEOMACHINE started the process of developing an automatic coating machine. After, two years of research and development, the first 'Neocota Automatic Coating System’ was manufactured in 1984.

During the last three decades, NEOMACHINE manufactured and marketed more than 550 machines, out of which 100 machines were exported to the different countries like the US, Australia, China, Jordan, Yemen, the UAE, Uganda, Kenya, Sudan, Cyprus, Saudi

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Arabia, Austria, Brazil, Bangladesh and Bolivia etc.

NEOMACHINE, a professionally managed organisation now has two manufacturing units in Kolkata, which are equipped with state-of-the-art equipment like fabrication, machining, assembling, finishing and other related jobs.

The company has been strictly following all the quality control guidelines during manufacturing. The bought-out items are inspected at the manufacturers’ works periodically. The company has a dedicated team of engineers for providing erection and commissioning and prompt after-sales service to

the clients.

The in-house R&D facility is abreast with latest technology upgradation and developments in ‘coating technology. This helps in continuous improvement of the product. NEOMACHINE also provides DQ/IQ/OQ/ documents for automatic coating system and are in the process of getting CE certification.

Over the years, the company has gained vast experiences in manufacturing 'automatic coating system' by interacting with various Indian and multinational pharma and confectionery units based in India and abroad.

Neomachine being a single product company manufacturing only automatic tablet coating system for coating of pharma tablets has gained vast experiences in latest coating technology as well as validation and qualification of coating equipment to qualify for audit of various national and international agencies. The latest models of NEOCOTA are having all the constructional features for validation and qualification. The equipment are supplied with all the necessary documents for proper validation during installation and commissioning as well as trial production.

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Sanofi India collaborates with NIPER Kolkata To promote academic excellence and research SANOFI INDIA signed a Memorandum of Understanding (MoU) with National Institute of Pharmaceutical Education and Research (NIPER) Kolkata, in the presence of Pranab Mukherjee, President, India. The collaboration with NIPER Kolkata, an autonomous body set up under the aegis of Department of Pharmaceuticals, GoI, will promote academic excellence and research in the areas of pharmaceuticals and consumer healthcare products, to cater to the current and future needs of the pharma industry.

Through this initiative, Sanofi India will

◗ Participate in revision or formulation of curriculum for a Post-Graduate (M.S.)/Ph.D. Programme ◗ Provide opportunities of internship or project work to NIPER Kolkata M.S./Ph.D. students at manufacturing sites ◗ Ensure association of R&D heads with the dissertation work of NIPER Students ◗ Provide career growth opportunities ◗ Undertake collaborative research activities in identified areas As per the MoU, the key deliverables for Sanofi India will be to assist NIPER Kolkata foster students with updated knowledge, and who are ready for the pharmaceutical industry. ◗ Repurposing of existing pharmaceuticals ◗ Novel small molecules for anti-diabetics and drug resistant tuberculosis ◗ API by Synthetic Biology / Cell Factory ◗ Phyto-pharmaceuticals ◗ Rare diseases of public health importance “The era of academia-industry collaboration to address the mammoth task of capacity building to meet our healthcare challenges has well and truly begun. Only a well-equipped and trained workforce can face

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future challenges and cater to the vast healthcare needs of the nation. We are proud to as-

sociate with NIPER Kolkata in this collaborative exercise to hone the students’ skill-sets,

and empower them for future, based on our practical knowledge and research experience,”

said Dr Shailesh Ayyangar, MD, Sanofi India.

EP News Bureau

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BCPL: On the path of revival and growth The country's oldest pharmaceutical company, Kolkata based Bengal Chemicals and Pharma Limited (BCPL) is on the path of regaining its past glory, thanks to the efforts taken by P M Chandraiah, MD (Additional Charge) & Director (Finance), BCPL. Express Pharma spoke to him to know more about his plans to rejig the fortunes of this century old PSU BCPL was formed by the great scientist Acharya PC Roy in 1901 and the company is running into losses for the past few decades. Explain why this company is in losses for a long time?

BCPL is a great company and it is the first pharma company in India established by great scientist Acharya P C Roy. Till early 1950s, it was running in profits but after the demise of Acharya PC Roy in 1944, from late 1950s, it started running into losses. Due to its prolonged years of losses and labour unrest, BCPL was nationalised in 1981. Now, the company is owned by Central Government. It was referred to the Board for Industrial and Financial Reconstruction (BIFR) in 1992 and was declared sick.

But recently, the working culture has improved a lot.

The reasons for losses were due to improper planning, labour unrest and also lack of team work .

What is the current status and future prospects of the company?

The company reported a net profit of ` 1.16 crores in the first half, which ended on September 30, 2016 and is confident of reporting profits from 2016-17 onwards and it will be the turnaround year for the company. Further, during the last two years, the performance has improved a lot and in 2015-16 the company reported loss of Rs 9 crore against a loss of Rs.17 Crore in 2014-15 and a loss of Rs 37 crore in 2013-14.

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Recently, Bengal Chemicals was awarded “Excellent” rating in Corporate Governance from Department of Public Enterprises, Government of India for the financial year 2015-16.

What are the steps taken to turnaround this Company and to achieve Net Profit during 2016-17?

We have taken a number of steps to make it a profitable in 2016-17 and we will take further steps to sustain the profitability in the long run.

For example, we were able to negotiate for reduced interest rates on our loans from our bankers, able to procure raw and packing materials at lesser rates, able to reduce the administrative expenses, etc. and requested Government of India to reduce interest rates on government loans to match with the rates of commercial banks. Recently, we have developed financial discipline as well as operational discipline with which we will be able to sustain its profitability in the long run.

We have taken a number of steps to make it a profitable in 2016-17 and we will take further steps to sustain the profitability in the long run

When did you join BCPL and what are the steps you have taken to change this company?

I have joined BCPL as Director (Finance) in November, 2014 and taken additional charge of MD from June, 2016. On the date of my joining, there were three annual accounts and six cost audits pending for finalisation and company was not able to finalise its accounts and submit the

same to DPE/Ministry because of which company’s MOU rating and Corporate Governance rating were rated poor for a number of years. After my joining, we have been able to conduct four AGMs and complete eight Cost Audit Reports within a short period of 16 months and BCPL has been the first Company, out of all the PSUs, to hold its Annual General Meeting of 2015-16 in July, 2016 itself. Due to the recent efforts, BCPL was able to get Excellent Corporate Governance Rating in 2015-16 from DPE. I had issued more than 60 Circulars/Guidelines for improvement of systems. I have developed financial discipline through various ways such as: ◗ Opening more than 200 salary accounts of the employees (earlier salary was paid through cash) ◗ Closing of more than 30 inoperative/less-operative bank accounts, ◗ Starting of rtgs/neft payment ◗ Discontinuing cheque payments ◗ Installing cc tvs in the offices and factory premises, ◗ Monitoring advance payments to employees, ◗ Streamlining the suppliers payment system, ◗ Introduction of quarterly tendering system, ◗ Introduction of annual appraisal system for its employees Further, as a part of improvement of the internal financial control systems in the company, we have stopped the entire cash

IPC SPECIAL/WEST BENGAL PHARMA REVIEW

transactions, opened separate bank account for collection of rental incomes, implementing five tier audit system i.e. (i) Banking transaction audit (ii) Management cross audit of one unit’s accounts by other units’ officials (iii) Internal audit by the Chartered Accountants’ firm (iv) Statutory audit by the Audit firm appointed by CAG and (v) Government audit i.e. by CAG Auditors.

With the above steps taken, I am confident that we will become a profit making entity in 2016-17 itself and we have already reported net profit in the first half ended on September 30, 2016. We will sustain profitability in

the long run with the help of guidelines/circulars issued by me in the recent past, recent cost cutting measures taken as explained above and also due to the improvement in the Internal Financial Control Systems in the Company.

What are the major products on which the company will focus in future to improve its turnover and profitability?

The company has recently commissioned its plants to manufacture various types of medicines. We will definitely focus more on the pharma division which is contributing more than 60 per cent of its turnover.

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We will definitely focus more on the pharma division which is contributing more than 60 per cent of its turnover Further, Pheneol brand itself is able to take this company to greater heights. So, we will also concentrate more on home products like Pheneol,

White Tiger, Naphthalene Balls, etc. for further growth.

We have plans to achieve a turnover of ` 200 crore by 2020 and also a matching respectable Net Profit on the said Turnover.

What is the message you want to give the loss making companies and also to their stakeholders?

The stakeholder of the loss making companies should vigilantly watch the activities and should analyse the reasons for their losses and take all necessary steps, without fear of losing popularity and favour to locality. They should also ensure that the company is in the right hands of a Chief

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Executive who will take up initiatives , treating the Company as his own , since he is one of the stakeholders and also a responsible citizen of the nation; then any sick company, whatever its activities may be and whichever the adverse conditions in which it is operating, will definitely become a Turnaround Company and sustain its activities and also keep its pride alive.

Message: “Keep your company in the hands of experienced, dynamic, honest and goal oriented leader for progress and sustainability” EP News Bureau

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Albert David to open new division to focus on gynaecology and orthopaedics It is a move to help the company to expand the customer base, product basket and its presence in various segments and achieve its growth objectives of the next five years KOLKATA'S LEADING pharma company, Albert David, a unit of Kothari Group, has initiated the process of opening a new division which would focus primarily in the therapeutic segments of gynaecology and orthopaedics and help the company achieve the growth objectives of the next five years.

To maintain its competitive edge in low price common dosage forms and to maintain the vibrancy of its product portfolio several newer formulations are being outsourced

in line with the growth strategy of the company. Reportedly, this move would also help the company to expand the customer base, product basket and its presence in various segments.

Currently, Albert David manufactures pharma formulations, bulk drugs and injections. It has manufacturing plants at Kolkata, Ghaziabad and Mandideep (Bhopal). The Kolkata factory produces tablets, powders, small volume parenterals, oral liquids and bulk drugs.

The Ghaziabad plant manu-

factures IV fluids in glass and polyethylene containers using Blow Fill Seal Technology (BFS), small volume parenterals and capsules. Plant located at Mandideep is dedicated to produce disposable syringes and needles.

Technology upgradation and a fully revamped Research & Development (R&D) department would support the growth plans of the company with more in-line oral solids, liquids and sterile liquid dosage forms.

The company also has an active Export Division which

is engaged in the process of developing specific dossiers for registration and future business in various countries.

The current export focus of Albert David Limited is restricted to the Rest of the World (ROW) markets.

In the last fiscal (2015-16), the company recorded a topline of Rs 321.30 crores and is expecting to touch Rs 345 crores by the end of March 2017.

The two launches, DHUP (Vitamin D3) and Inbalanse (Probiotic) would not only add to increase the net turnover of

the company but will also open up newer therapeutic segment to ensure rapid growth and facilitate future launches.

Understanding the challenges which has risen due to various government policies, viz. FDC Ban, DPCO and stricter regulatory norms for both pharma formulations and FSSAI products, the company has put its strategies in place to tide over such hardships and sail through successfully to achieve its business goals.

EP News Bureau

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NBZ

NBZ PHARMA LTD.

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Factory: NBZ Pharma Ltd. R-905, T.T.C. Indl. Area, M.I.D.C, Rabale, Navi Mumbai - 400 701.

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Sub-Visible Particles Characterisation and Prevention Sub-Visible Particles are a cause of regulatory concern due to their immunogenic and difficult to characterize nature. Regulatory bodies increasingly insist on not only detecting and sizing sub-visible particles, but also on counting them and differentiating protein from non-protein. Malvern is the solution-provider of choice for generating confidence in the quality of injectable formulations.

Size and Count

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Nanoparticle Tracking Analysis (NTA) visualises the light scattered by particle motion and uses this information to calculate the size and concentration of each particle present

Archimedes Resonant Mass Measurement (RMM) system differentiates silicon from protein particles through analysis of particle density, whilst Morphologi G3-ID static imaging system chemically identifies particles using Raman spectroscopy

Microcal DSC is used by formulation labs around the world to screen and improve formulation stability, giving confidence in the shelf-life of a product and ensuring that sub-visible particle development is minimised

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Wiper Type Sight Glass

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Shah Brothers introducing

DIN 100 Light Glass LED

Swastik Associates

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Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: pharma@shahbros.com

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To Advertise in

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Auriga Research Pvt. Ltd. (Arbro Analytical Division.)

Instruments

Testing & Analysis of Products Method Development & Validation Shelf Life Studies / Stability Studies Clinical Trails Online Training on Analytical Techniques

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Accreditations, Recognized & Approvals NABL (ISO 17025:2005), NPCB Malaysia, CDSCO, FSSAI, GLP Certificate (Drug Control Dept.), APEDA, FSVPS - RUSSIA, DST, EIC/EIA, AGMARK

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ANALYTICAL LABORATORY,BADDI (UNIT - III) Dev Chaudhary Complex, P.O : Mannapura,Tehsil - Nalagarh, Distt. : Solan, Himachal Pradesh Contact No. : +91-09318759781-82 E-mail : baddi@aurigaresearch.com

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PHARMA LIFE One Brand Total Solution

AWARD

Industry stalwarts mark their presence at 4th Edition of India Pharma Awards The awards recognised thought leadership on a global scale by unveiling top pharma innovators and champions from various industry verticals

The winners at the 4th Annual India Pharma Awards, an endeavour that recognised and celebrated the excellence, achievements and innovations of pharma industry stalwarts

BM India's 4th edition of India Pharma Awards, presented

by Fette Compacting, recognised all the stakeholders of the pharma industry at a recently held event in Mumbai. The awards recognised thought leadership on a global scale, by unveiling top pharma innovators and champions from various industry verticals.

India Pharma Awards 2016 brought together industry

U

champions and policy makers from around the world on one platform. Apart from the recognition ceremony, the awards night featured presentations by industry stalwarts, entertainment acts and networking sessions.

The scope of the event got bigger this year with the increased number of nomination categories. The award entries were evaluated by an esteemed panel of jury who judged the contribution of

To subscribe: bpd.subscription@expressindia.com

India Pharma Awards 2016 covered a wide range of activities of the India pharma sector through 25 different nomination-based categories Indian pharma companies on various grounds. The jury panel comprised eminent names from the industry,

bringing in a wide canvas of experience, Dr Ajit Dangi, President and CEO, Danssen Consulting; SV Veerramani,

President, Indian Drug Manufacturers' Association; Satish Waman Wagh, CMD, Supriya Lifescience; Chakravarthi AVPS, CEO and MD, Ecobliss India; Vinod Kalani, Vice Chairman, Confederation of Indian Pharma Industry and SM Mudda, Director, Global Strategy (Technical),Micro Labs, Mumbai.

The evening began with the opening speech by Yogesh Mudras, MD, UBM India followed by a keynote address by

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PHARMA LIFE

One Brand Total Solution

THE WINNERS INCLUDED Award category

Company name

Excellence in Brand/Product - Prescription Drugs

Micro Labs

Excellence in Brand/Product - Others

Ari Healthcare

Excellence in Contract Manufacturing

Akums Drugs And Pharmaceuticals

Excellence in Corporate Social Responsibility

Sun Pharmaceutical Industries

Excellence in Export Promotion

Hetero Labs

Excellence in Health & Safety

Lupin

Excellence in HR

Aurobindo Pharma

Excellence in Marketing - Prescription Drugs

Janssen India - Johnson & Johnson

Excellence in Marketing - Others

Abbott India

Excellence in Patient Engagement

Dr Reddy's Laboratories

Excellence in Pharma IT Technology

Aurobindo Pharma

Excellence in Pharmaceutical Machinery

ACG Inspection Systems

Excellence in Supply Chain & Logistics Management

Dr Reddy's Laboratories

Operational Excellence

Lupin

Jury Based Recognition Lifetime Achievement Award

Dr Cyrus Poonawalla, Chairman, Poonawalla Group

Emerging Leader Award

Rajeev Nannapaneni, Vice-Chairman and CEO, Natco Pharma

Business Leader Award

Ramesh Juneja, CEO and Chairman, Mankind Pharma

Woman Leader of the Year

Aditi Kare-Panandikar, MD, Indoco Remedies

Special Jury Award

Dr Appaji PV - Director General, Pharmexcil

UBM Initiative Awards UBM Initiative Recognition - Emerging Exporters of the Year

Cachet Pharmaceuticals

UBM Initiative Recognition - Trusted Turnkey Consultants of the Industry

BK Doshi & KK Doshi (Doshi Consultants

UBM Initiative Recognition - Leading Manufacturers in IV Fluids & Finished Formulations

Aishwarya Group

UBM Initiative Recognition - Leading Company in Delivery & Safety Systems for Injectable Drugs

West Pharmaceuticals Packaging India

Sandeep Sood, MD, Fette Compacting.nand its stakeholders.

India Pharma Awards 2016 covered a wide range of activities of the India pharma sec-

tor through 25 different nomination-based categories. The categories were more com-

prehensive as compared to the 2015 edition and it encompassed all the facets of

pharma business.

EP News Bureau

APPOINTMENT

Cipla appoints Ireena Vittal as an Independent Director on its Board She is recognised as a thought leader for consumer-facing companies in emerging markets CIPLA HAS announced the appointment of Ireena Vittal as an Independent Director on its Board with effect from December 1, 2016. Vittal, a former partner with McKinsey & Company, is an MBA from Indian Institute of Management, Kolkata. She has over two

120 EXPRESS PHARMA December 16-31, 2016

decades of experience in management consulting and is recognised as a thought leader for consumer-facing companies in emerging markets. Prior to joining McKinsey, Vittal worked with Nestle and MaxTouch (now Vodafone). She has also served government and

public institutions to design and implement solutions core to India’s development, such as inclusive urban development and sustainable rural growth.

Welcoming her appointment as an independent director, Dr YK Hamied, Non-Executive Chairman, Cipla said, “We

are delighted to welcome Vittal to our Board. Cipla is in the midst of preparing itself for an exciting future and her background of both business and advisory will be very useful to the company.”

Ireena Vittal said, “I am honoured to have been invited to

join the Board of one of India's most respected and iconic companies. These are very exciting times for Cipla as it transforms itself to be even more relevant to the millions of patients globally.”

EP News Bureau

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