Express Pharma January 01-15, 2018

CONTENTS

TRENDS IN 2018

Vol.13 No.5 January 1-15, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana

As the new year comes calling, industry experts reflect on the trends which would rule the sector and shape its future | pg 16

New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble

MARKET

Chief Designer Prasad Tate Senior Designer Rekha Bisht

MANAGEMENT

32

CAN INDIAN PHARMA INC. FIND ITS LOST MOJO?

52

33

POLICY EXPERIENCES OF 2017 FOR PHARMA SECTOR

53

Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

10

PHARMA COS PREFER TO WORK WITH FEW STRATEGIC CDMO PARTNERS

12

WE ARE IN THE PROCESS OF IMPLEMENTING A $200 MILLION GROWTH CAPEX PLAN TO EXPAND CAPACITY AND EXTEND CAPABILITIES

PHARMA LIFE I NEED TO SORT OUT CHALLENGES WHICH HAVE EMERGED DUE TO GOVT POLICIES OUT-OF THE BOX THINKING IS THE WORD FOR SUCCESS

RESEARCH

34

KRABEVA WILL BE AN IMPORTANT ADDITION TO OUR ONCOLOGY PORTFOLIO OF NOVEL BIOLOGICS AS WELL AS BIOSIMILARS

35

ROCHE DRUG COCKTAIL DOUBLES CHANCE OF HOLDING LUNG CANCER AT BAY

36

TRIAL RESULTS OF ZIKA VACCINE SANOFI DROPPED SHOW PROMISE

Automation solutions for PHARMA industry www.br-automation.com

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18.

Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. 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.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

7

January 1-15, 2018

EDITOR’S NOTE

It’s Centre vs states, once again

A

recent amendment to the Drugs and Cosmetics Rule 1945, and subsequent notification, has once again revived the turf war between the centre and state level drug inspectors. The notification GSR1337(E) dated October 27, 2017, deals with validity of licenses and provision for joint inspections of pharma manufacturing facilities by drug inspectors of the state and the centre prior to issuing licenses.

In a letter dated November 14, to the Health Minister, M Dhilip Kumar, President, All India Drugs Control Officers' Confederation (AIDCOC) says the amendment will lead to "dual control which will lead to delay and undue hardship to the licensee and will also adversely affect the state government's ability to provide services with the desired speed and within specified time limit." The letter has requested the health minister to keep the amendment in abeyance till a final decision is taken.

While the division of responsibilities between the Central and state governments require legal opinion, logistics suggest that the present staff strength and geographical footprint of the central drug authority do not match up to that of the state drug control machinery.

According to the AIDCOC letter, state drug departments have approximately 3,000 experienced staff to monitor the manufacturing licenses of the approximately 10,000 pharma units in the country. In contrast, the total sanctioned strength of inspectors under central government is reportedly 271, of which 147 are recently recruited and therefore not trained.

Thus only 124 trained drug inspectors attached to the central government are available for proposed joint inspections.

To make matters worse, these joint inspections will be in addition to their current duties related to the Central Licence Approving Authority (CLAA) and joint inspections in WHO-GMP, Certificate of Pharmaceutical Products (COPP), EU-WC etc. The implication is that joint inspections could disrupt the normal duties of centrally attached drug inspectors.

In terms of geographical spread, the letter points out that the CDSCO does not have offices in some states like Andhra Pradesh, Odisha etc so manufacturers in these states would find their offices inaccessible. In contrast, state drug officers/inspectors are present at sub-divisional level, supervised at the district and regional levels, and are hence able to inspect, monitor and issues approvals and licenses within the time frame.

The current system of the CDSCO at the centre focussing on policy issues, leaving the state resources

AIDCOC says the proposed joint inspections of pharma manufacturing facilities by drug inspectors of the state and centre will lead to “dual control...delay and undue hardship to licensees”

to focus on implementation, has served India's pharma sector very well. It has grown into a $36 billion industry, more than 50 per cent of this being exports to highly regulated markets. The Pharmacy of the World is dependent on numerous manufacturers across the country, and these in turn, need an accessible and streamlined regulatory mechanism.

While the sector looks to the CDSCO to focus on quality, exports/imports and policies, the state machinery is best positioned towards licensing and inspections.

If Prime Minister Modi's Ease of Doing Business (EoDB) initiative is about decentralising decision making and devolving responsibilities to the relevant stakeholders, then the proposal for joint inspections seems like a step backwards. Instead of empowering the state level inspectors with more authority, it seems to be adopting a 'Big Brother' approach. Joint inspections cannot be seen as a hand holding and resource building exercise, say sources, as it will weaken rather than strengthen their roles.

To be fair, the proposal for joint inspections is still a work-in-progress. The Drug Controller General (India) (DCGI) followed up with a letter dated November 24 to all state/union territory drug controllers, which mentioned that detailed guidelines would be prepared in consultation with the state drug controllers and other stakeholders "for effective and uniform implementation of the joint inspection of manufacturing premises."

Given that their previous representation went unheeded, AIDCOC has decided to take things to the next level. State drugs controllers met on December 16 and planned future strategy. AIDCOC has since filed a writ petition in the Chennai High Court asking that the amendment be declared as ‘ultra vires, unconstitutional, arbitrary and illegal.’ We have clearly not heard the last on this issue.

There does seem to be a genuine move to increase EoDB in the pharma sector. At the recently held 14th National Pharmaceutical Conclave 2017, Dr GN Singh, DCG(I) said his office is working towards making the regulatory framework seamless in the next six months. A CII-KPMG report on ‘Ease of Doing Business in the Pharma Sector’ released at the event presented recommendations from industry related to the marketing authorisation process, clinical trials and manufacturing approvals. But such recommendations will remain on paper, if all stakeholders do not resolve conflicts, define a common goal and then work towards it.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

8

EXPRESS PHARMA

January 1-15, 2018

MARKET I N T E R V I E W

Pharma cos prefer to work with few strategic CDMO partners As the CDMO industry undergoes significant consolidation, Vivek Sharma, CEO, Piramal Pharma Solutions (PPS) explains to Viveka Roychowdhury how PPS’ latest acquisition of US based CDMO Ash Stevens will help position it as an integrated CDMO for oncology drugs

How does the agreement to acquire 100 per cent stake in Ash Stevens Inc, a US-based CDMO, fit into the company's business strategy?

The percentage of drugs classified as ‘highly potent’ with occupational exposure limits (OELs) ≤ 10µg/m3, has been progressively increasing, and is currently estimated to be around 25 per cent of the global pharmaceutical development pipeline. High Potent Active Pharmaceutical Ingredients (HPAPIs), the active ingredients that contribute towards efficacy of these drugs, make up one of the fastest growing segments of the global API market. In response to increasing customer demand for HPAPIs, we acquired USbased CDMO Ash Stevens to add HPAPI capabilities to our portfolio. The company has extensive experience in handling highly potent compounds and is seeing increased demands for its offerings.

The acquisition of Ash Stevens also fits well with Piramal’s strategy to build an integrated asset platform that offers value to our partners and collaborators. North America being a key market for Piramal, this development helps to serve our customers with three local facilities including the injectable facility in Kentucky for fill

10

EXPRESS PHARMA

January 1-15, 2018

working in an oncology injectable formulation, can get all their needs served at Piramal: Piramal would make the early intermediates out of India, manufacture the active (HPAPI) out of Riverview, and finally, complete the injectable drug product out of its Kentucky facility.

Our core values of Knowledge, Action, Care and Impact serve as our guiding principles and resonate with all our customers finish needs, the Toronto facility for complex high value APIs, and now, Ash Stevens in Riverview for HPAPIs. This acquisition is synergistic with

our global capabilities and can help fulfill client requirements as an Integrated CDMO for Oncology drugs. As an example, a collaborator

How has the CDMO landscape evolved in the past few decades?

Pharma firms have always adapted to the changing market place by adopting different strategies like launching authorised generics, having a generic arm to tap the generic market, acquiring biotechs to boost the pipeline, joint ventures, co-marketing agreements and so on. Declining R&D productivity and the impact of clinical attrition have driven many pharma companies to focus on core competencies, adopt outsourcing as a strategy and rationalise their manufacturing and R&D operations. They prefer to work with few strategic CDMO partners instead of multiple suppliers to take advantage of cost and time benefits. In response to these macro trends, the CDMO industry has undergone significant consolidation in the past few years to obtain proximity to clients and their end markets through a network of global sites.

Integrated service providers

now offer ‘end to end services’ from discovery to commercial launch.

With the advent of personalised medicine, niche disease targets, and biologics, there has been a shift from large volume drugs to low volume, targeted, and potent drugs with novel delivery systems and dosage forms. To meet these needs, CDMOs are adding specific capabilities such as high potency manufacturing, continuous flow, and unique formulation services to their portfolio.

Piramal is a global leader in integrated solutions and our platform of services and global facilities allow customers to work with us across different phases of the drug life cycle for both drug substance and drug product, optimising costs and time.

As a global supplier, how do you prepare to cope with political changes like Brexit? Has this impacted business?

We regularly track both market dynamics and geopolitical trends. Piramal’s network of sites across North America, Europe, and Asia allows us the flexibility to quickly adapt and address any rapid shifts in policies and trends. Specifically on Brexit, our current view is that, the impact, if any, will be nondisruptive. We are working closely with our peers, government officials,

What are the business growth drivers and possible speed breakers? Would increasing quality expectations from regulators add to the cost of

doing business and how is this impacting your revenues?

At Piramal, there is no tradeoff between quality and being cost effective. We consider them mutually exclusive.

Without quality, cost competitiveness would not matter. We at Piramal have focussed on ‘Quality as a

Culture’, as opposed to Quality as a Compliance Tool’.

With a strong quality framework in place, Piramal seeks to be competitive by building a brand that stands out. We view Quality as our identity – something which represents our DNA. We employ the concept of “Global Vision, Local Execution”

which enables each site to serve their customers at their location but with the global standard of quality upheld by Piramal. Finally, we channelise our efforts to ensure that quality is our differentiator – which attracts customers scouting for ‘preferred’ partners. viveka.r@expressindia.com

Quality. Speed. Simplicity.

For more than 90 years, you’ve known West as a packaging partner with a patient focus, quality products and global reach. Now get to know us for our speed and simplicity.

West is pleased to introduce AccelTRATM - a new program designed to meet the needs of the generics injectable market.

• Meets Global Compendia • Industry Leading Extractables and Leachables Profile • Functional Performance

Q u a li t y • Optimized Lead Times • As low as one week • Trial and Commercial quantities • Proactive Technical Support

e Spe

d

What is the differentiator between Piramal Pharma Solutions' portfolio and other CDMOs? Our core values of Knowledge, Action, Care and Impact serve as our guiding principles and resonate with all our customers. These values have been shaped by our tradition and collective experience; they determine how we engage with others, what we identify with and what we value.

We have created a global network of development and manufacturing facilities located in North America, Europe and Asia that offers a multitude of services covering the entire drug life cycle, from drug discovery & development to commercial manufacturing of Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). This sets us apart as the only service provider with a significant presence in the East and West which enables us to leverage the cost efficiencies from the east and proximity to our customers and their end markets in the west to offer truly integrated solutions.

Irrespective of our businesses, Piramal is built around three pillars that form our ‘One Piramal’ foundation: Quality, Environmental Health and Safety (EHS) and Customer Centricity. From the shop floor to the executive suites, there is no compromise in these elements. These principles are highly valued by our customers in the industry that we operate in. We constantly engage with our customers to identify

improvement opportunities and focus on meeting customer expectations collaboratively.

lic ity

influencers, and customers, to ensure that legislation does not impact the availability and access for life saving medicines, for patients in the UK, and the European Union.

While we remain optimistic that the final decision will take all this into consideration, we have alternate plans in place for QP release in the event that those get impacted: our goal will be to ensure that our customers have business continuity and get their products on time/in full.

• Single Next Generation Formulation 4031 • Stoppers • 13 & 20 mm • Serum and Lyo • Westar® RS & RU Certified • Global Availability

p Sim

For more information, contact West today.

www.westpharma.com West and the diamond logo, AccelTRA and Westar are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. © 2017 West Pharmaceutical Services, Inc.

EXPRESS PHARMA

11

January 1-15, 2018

10166 0317

MARKET I N T E R V I E W

We are in the process of implementing a $200 million growth capex plan to expand capacity and extend capabilities Syngene, a major CRO in India, has been systematically investing in expanding its existing capacities as well as setting up new infrastructure to add new capabilities. Jonathan Hunt, CEO, Syngene divulges more about the company's ambitious capex plans, its growth strategies, its vision for India, etc. in an exclusive interview with Lakshmipriya Nair How is the Indian CRO market growing vis-a-vis the global market and is Syngene poised to leverage the growth opportunities?

According to a Frost & Sullivan report, the global CRO market is expected to grow from around $32 billion in 2015 to $57 billion in 2020 at a CAGR of over 12 per cent. Within this, Syngene is well placed in the global context to capitalise on this growth. From a discovery chemistry focussed CRO, Syngene has evolved to become a full service global scientific services provider offering a range of integrated discovery and development solutions to a global customer base.

Our clients range from world-leading MNCs to small, start-up organisations in the pharma and biotechnology as well as adjacent industries such as nutrition, consumer goods, animal health etc.

Our scale and broad range of services allows us to offer tailor-made solutions to our clients to match their long term strategies as well as remain consistently cost competitive.

Our dedicated R&D centre vertical is a differentiated business model that helps us play a more integral part in our client’s R&D strategy and is seeing increased traction in recent years as many clients move from purely seeking cost arbitrages to looking for ways to boost innovation and deliver more science per dollar of investment. Our key

12

EXPRESS PHARMA

January 1-15, 2018

differentiators are our world-class infrastructure (successfully inspected by multiple global regulatory authorities), a track record of delivering scientific innovation, excellent scientific talent pool, a senior leadership team that has a depth of global experience and a proven track record of quality compliance (six successful US FDA and two EMA inspections in the last three years) and IP protection.

Can you elaborate on how strategic collaborations have enhanced Syngene’s scientific capabilities and expertise?

Over the years, Syngene has entered into strategic, multiyear collaborations with many large and medium-sized organisations which enable our scientists to work very closely with client teams on integrated discovery and development projects. This continuous engagement helps us build a deep understanding and insight into our client’s R&D requirements. This insight helps us align our capabilities and resources to meet these future needs. Through this approach, we become a longterm strategic partner for our client, providing them value-added services rather than just a transactional service provider. A case in point is our dedicated R&D centres, a differentiated business model where we set up exclusive research

infrastructure for a particular client with a dedicated team of Syngene scientists working exclusively for that particular client. We currently run dedicated R&D centres for BMS, Amgen, Baxter and Herbalife. These are centres of excellence that play a critical role in the client’s R&D operations. For instance, BBRC, the dedicated R&D Centre set up for BMS, is their largest R&D infrastructure outside the US and has significantly contributed to the discovery and pre-clinical development of numerous drug candidates for further study.

What is likely to be the future of CRO-pharma relationships and how will it affect the R&D goals of the industry?

The CRO-pharma relation will continue to grow stronger in the coming years.

Outsourcing R&D activities to the CRO industry is an extremely effective way for the pharma and biotech industries to overcome their R&D challenges. The relation between the two industries has evolved from the initial transactional or 'fee-forservice' model largely focusing on cost advantage to a more strategic and longterm relation with focus shifting to quality and timely delivery. As the complexities of R&D increases, collaborations with CROs offering integrated services

MARKET across discovery and development are more and more preferred to get access to not only the required skills and technologies but also to a range of services such as novel drug targets, validation of targets, signal transduction pathway know-how, animal models, disease expertise, translational medicine knowhow and biomarkers.

Outsourcing at the early development stages to CROs with bioanalytical expertise is also helping drug manufacturers identify the most promising candidates much earlier, thus reducing overall R&D expenditures.

Clients are also increasingly looking at improving quality and efficiency, gaining

in the process of implementing a $200 million growth capex plan to expand capacity as well as extend our capabilities. Our bioinformatics business is now well integrated into our other services and we expect it to start contributing more strongly to our revenues in the coming year. There is increasing demand for biology

and biologic- based services globally and we are starting to see good traction here with our investments in adding to our capabilities and capacities.

Our newest biologics manufacturing facility is nearing completion while our new formulation facility is now operational adding to our capacities and we expect to see

increased growth in this area.

We are making good progress on our dedicated R&D centre vertical and expect to further increase their numbers as well as scope in the coming years.

Our fully-integrated drug discovery dedicated centre model continues to get traction with clients and this model is a testimony of our

ability to bring a full range of capabilities to solve a range of complex scientific problems.

Our Mangalore manufacturing project is also progressing on schedule and once operational, it will significantly boost our commercial scale manufacturing capacities. lakshmipriya.nair@expressindia.com

Our scale and broad range of services allows us to offer tailor-made solutions to our clients to match their long term strategies as well as remain consistently cost competitive competitive advantage and strengthening operational and technical expertise through their outsourcing partners.

What are your growth strategies for next three years?

Globally, we anticipate to see a healthy demand for high quality scientific services, not just in the pharma and biotechnology industries but also in other research focused industries like nutrition, agrochemicals, consumer goods and other industries that Syngene caters to. We are

PROCESS & PLANT ENGINEERING Solutions for your investment projects in pharmaceutical, biotech and food industries. » » » » »

Consulting: project development + feasibility studies + technical due diligence + GMP audits + licenses.

Planning: conceptual design + basic engineering + detail engineering + execution engineering + general planning.

Implementation: procurement + delivery + building and consturction supervision + commissioning.

Validation & qualification: comprehensive GMP compliance + integrated concept.

Project management.

We combine professional engineering with in-depth technology expertise. Worldwide!

You benefit from flexible and reliable engineering solutions from 'one source'.

Glatt (India) Engineering Pvt. Ltd. | Plot No. 251, Okhla Industrial Estate, Phase III, New Delhi – 110020, India Tel + 91 11 40 85 85 85 | info@glatt-india.com | www.glatt.com

EXPRESS PHARMA

13

January 1-15, 2018

Contact person: Mr. Anoop Razdan - Head of Engineering & GM Projects | email: anoop.razdan@glatt-india.com

Glatt. Integrated Process Solutions.

MARKET DEAL TRACKER

Pharma, health industry posts 59 deals worth $5 bn in Nov ’17 M&A activity was focussed in Asia-Pacific, particularly China THE PHARMACEUTICAL and healthcare industry reported 59 deals worth $5 billion in November 2017. Of $5 billion, Asia-Pacific accounted for 78 per cent of the activity, of which 50per cent was contributed by the Chinese companies. The M&A activity recorded in Asia-Pacific in November is the highest, both in value and volume terms (29 per cent in November), since June 2017 considering that Asia-Pacific accounted for 9 per cent of the total deal value and 22 per cent of total deal volume between June 2017 and October 2017. Shanghai Pharmaceutical’s proposed acquisition of the Cardinal Health’s business in China is expected to strengthen its presence in the pharma and medical products distribution market as well as facilitate the growth of its pharma manufacturing business, enabling it to play a significant role in the government’s ‘Healthy China’ initiative.

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

14-Nov-17

Shanghai Pharmaceutical (China)

Cardinal Health - China Business (China)

1,200.0

29-Nov-17

Torrent Pharmaceuticals (India)

Unichem Labs - Domestic Formulations Business (India)

556.6

30-Nov-17

DNA Link (South Korea)

L&C Bio (South Korea)

529.8

29-Nov-17

Kaisa Group Holdings (China)

Zhenxing Biopharmaceutical and Chemical Co (China)

331.7

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

7-Nov-17

Athyrium Capital Management

Progenity Inc (US)

125.0

30-Nov-17

F-Prime; ARCH Venture Partners; Novartis; Medtronic; Healthcare Royalty Partners; MPM Capital; Sinopharm Capital Management; ORI Healthcare Fund; Eight Roads Ventures; JDRFT1D Fund; 6 Dimensions Capital; Wu Capital

Semma Therapeutics Inc (US)

114.0

13-Nov-17

Wellington Management Company; The Column Group; HillHouse; The Invus Group; EcoR1 Capital; Aisling Capital; Leerink Partners; Google Ventures; Decheng Capital; Celgene Corp; Foresite Capital Management; Droia NV; Taiho Ventures; BVF Partners

Arcus Biosciences Inc (US)

107.0

2-Nov-17

SAIF Partners; Ping An Ventures; ShenZhen GTJA Investment Group; Softbank China Venture Capital (SBCVC)

Annoroad Gene Technology Co. Ltd (China)

105.0

29-Nov-17

EcoR1 Capital; Alexandria Venture Investments; Flagship Pioneering; ARCH Venture Partners; Fidelity Management & Research Company; Alaska Permanent Fund Corporation; Qatar Investment Authority; Boxer Capital; Sirona Capital; Casdin Capital

Codiak BioSciences Inc (US)

76.5

M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

Source: GlobalData

14

EXPRESS PHARMA

January 1-15, 2018

904.1

3-Nov-17

Deals activity The venture capital market recorded an increase in deal value while there was a drop in the deal volume with November 2017 recording 70 deals worth $1.3 billion when compared to five months average of 79 deals worth $1.2 billion. Progenity, Semma Therapeutics, Arcus Biosciences and Annoroad Gene Technology are the companies which have raised more than $100 million each in November 2017.

Nanjing Xinjiekou Department Store (China) Shiding Shengwu Biotechnology Hong Kong Trading (China)

VENTURE FINANCING TREND ANALYSIS

Source: GlobalData

MARKET PRE EVENT

India Pharma 2018 to be held in Bengaluru The event to be held from February 15-17, 2017, will be organised by DoP and FICCI INDIA PHARMA 2018 will be held in Bengaluru from February 15 to 17, 2017. India Pharma 2018, 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) to 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.

The theme for the conference is ‘Shaping the Future of India Pharma Industry.’ The conference will encompass informative and interactive sessions aimed at understanding trends, strategic initiatives, opportunities and challenges in different facets of the Indian pharma and biotech industry including clinical research, data integrity, sector skills challenges and biopharmaceuticals. Other highlights of the conference will be CEOs’ roundtable, international regulators’ meet, investors’ session and workshops. India Pharma 2018 strives to provide a platform where participants can learn about the best practices and global experiences, interact with industry leaders, exchange innovative ideas and explore areas of collaboration between the various stakeholders in the pharma industry.

India Pharma 2018 will cover all the sectors of the pharma industry starting from finished formulations, APIs, bio-pharmaveuticals, fine chemicals and intermediates, natural extracts, excipients and many more. Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will be displayed.

EP News Bureau

EXPRESS PHARMA

15

January 1-15, 2018

Integrated automation had its day:

The future belongs to SCALABILITY+ www.br-automation.com/ScalabilityPlus sales.in@br-automation.com +91-20-41478999

Your machine technology Our technology packages Integrated automation PCs & Panels PLC systems Motion control Safety technology

Scalability+ takes integrated automation into a whole new dimension.

We enrich our extensive and seamlessly integrated hardware portfolio with a large set of technology packages. The openness of our platform enables our customers to turn their core competencies into a highly competitive solution and take machinery to the next level.

cover )

INSIDE

18 16

PHARMATRENDS IN 2018 AND BEYOND

EXPRESS PHARMA

January 1-15, 2018

20

TRACKING BIOSIMILAR TRENDS

22

POISED FOR A STRONG GROWTH

24

‘PATIENTS AND CONSUMERS WILL BE LOOKING FOR CONVENIENTAND INTUITIVE PACKAGING FORMATS’

(

26

DIGITECH: REVOLUTIONISING HEALTHCARE

28

To subscribe: bpd.subscription@expressindia.com

RAMPING UP R&D— KEYTO SUCCESS

29

A NEW ERA IN PHARMA BUSINESS

THE MAIN FOCUS

30

‘DRUG MANUFACTURERS WILLTURN TO SOLUTIONS THAT ENABLE DECREASED COATING TIMES’

EXPRESS PHARMA

17

January 1-15, 2018

cover )

Pharma trends in 2018 and beyond Anil Khanna, Partner, Wisdomsmith Advisors, gives an insight about pharma trends in 2018 and how the sector can go forward by overcoming the challenges

“I

am looking forward to the future and feeling grateful for the past” probably sums up best the sentiment of the Indian pharma industry, as it enters 2018, and plans its future.

It should be grateful about the past, as the industry did really well during the last decade, with both domestic and export growth engines speeding ahead. The industry grew strongly, profitability increased, balance sheets strengthened, shareholders were happy, retail investors made money.

However, at the end of 2016, and right through the 2017, industry grappled with two significant challenges – demonetisation and GST. While demonetisation, essentially became a working capital issue, as distributors – who largely deal in cash (no longer now!), were forced to reduce their inventory, as they couldn’t make timely payments to the companies. And a month prior to the GST implementation, stock off take virtually came to standstill.

Even more than three months after the GST roll-out, normal inventory days (45) of the distribution pipeline is yet to be restored. Most companies lost 4560 days of sales due to GST. Nevertheless, the pharma industry would heave a sigh of relief that all this is behind us, and by-and-large, the industry has come out of these challenges, without much of a bloodbath.

So, what’s next?

Both the growth engines of the Indian pharma – exports and domestic business, are facing challenges. On the domestic front, while there aren’t going to be any immediate radical challenges during 2018 (thankfully, Modiji will now be

18

EXPRESS PHARMA

January 1-15, 2018

companies acquiring assets at high prices. We saw transactions close for multiples exceeding 15x EBITDA. This was done to create future growth in an over-inflated industry. As companies started to see price erosion, the fight for market share intensified, and the basis for synergies and acquisition multiples of past acquisitions were no longer justified. Unsurprisingly, this has caused widespread panic, which has essentially changed the industry overnight. The whole industry entered into a downward spiral.

focussed on 2019 elections), like demonetisation or GST, but the industry will still continue to face other challenges, about which we will discuss later.

It’s on the exports front, which contributes more than 60 per cent revenue of the large pharma, primarily the US, where the challenges are bigger in magnitude.

Export market trends for 2018 Two years ago, many of the big generic pharma companies seemed invincible. But as generic pharma companies issue their results, there is a clear pattern emerging - underperformance and changes in quarterly and annual guidance to the market. It’s a trend that has hit publicly listed US companies like Teva, Mylan, Sun Pharma, Hikma and Lupin, to name a few.

Since January 2016, the index for listed generic companies dropped by 57 per cent. Meanwhile, the broader S&P index grew well over 20 per cent in that same period of time.

The truth is, this is not just a passing storm which has hit the industry; this is a drastic 'climate change' - and it’s here to stay.

Many generic companies in the US market are currently struggling. Many analysts and managers in the US pharma industry have been taken by surprise at how fast this has happened. Others are in denial, asking 'How did this happen?”

The recipe for a perfect storm The consolidation of the US generic pharma customer base has been occurring since the

What lies ahead? formation of a true substitutable market. Wholesalers have started teaming up with retailers in joint ventures that allow the partnership to act as one unit. Currently, there are three material customers in generic pharma: WBAD, ClarusOne, and Red Oak. Together, they control around 90 per cent of the entire US generics market.

There has also been enormous consolidation among payers. Today, three main payers in the US market — Express Scripts, Caremark and OptumRx — process more than 75 per cent of the store-based retail prescription claims. This has put more pressure upstream in the channel and forced the three large wholesalers/retail groups — WBAD, Clarus One and Red Oak — to pass price savings to them. The result has been a similar loss in profitability for WBAD, Clarus One and Red Oak, which in turn has created more pricing pressure on manufacturers.

Until 2015, the industry was at its peak with many generic

Looking forward, period of massive consolidation is predicted. Some companies will struggle with debt — divesting assets, merging and selling. Others may even go bust, a phenomenon almost unheard of in our industry. However, any company with access to cash will be better positioned to take advantage of the current situation.

The second key trend would be focus on biosimilars. Today, the largest pharma products are biologics and many generic companies would need to invest in biosimilars today to position themselves for the market of the future. Within the next 10 years, a top 10 generic company in the US will be unable to maintain growth or profitability without a biosimilar pipeline. It won’t be long before the largest generic products in the world emerge from launches of biosimilars into the US market, it could be as large as $1 billion.

One key thing the generic pharma industry need to realise is that the industry has changed suddenly and permanently. And

while there will be a lot of turbulence going forward, in 2018 and onwards, there will also be opportunities. It is now up to each stakeholder to determine the best way forward for them.

In a nutshell ◗ In 2018, global pharma will likely grow in the low-singledigit range, about three per cent, slower than recent years due to patent expirations and a continued negative pricing environment for generic and some speciality products. ◗ Patent expirations abound in 2018, with several large companies like Merck & Co. Inc., Novartis, Eli Lily & Co, and Valeant Pharmaceuticals International, face headwinds from drugs going off-patent. ◗ Generic pharma industry will remain challenged in 2018, as high-single-digit price declines on older generics will not be offset by new product launches. ◗ Margins will more or less remain flat in 2018 ◗ While M&A slowed somewhat, due to environment challenges and the tax reform, but slower organic growth, decreasing profitability, higher volatility of revenues, increasing development and marketing costs, will eventually lead to increased M&As, to drive revenue growth. Still, most large players in pharma have healthy balance sheets and debt capacity

Domestic market trend for 2018 In the domestic market, pharma industry will not have challenges in the classical sense of terms, but 2018 would be the harbinger of the paradigm shifting changes.

With the advent of GST,

( supply chain and distribution will see radical changes. Industry and the veterans are already thinking and have started to conceptualise alternate scenarios. For instance, the number of CFAs would gradually reduce and this layer of pharma distribution may completely vanish in five to seven years.

Let’s say, a pharma company had individual CFAs in Delhi, Gurgaon. Faridabad, Noida and Ghaziabad (called NCR region) in pre-GST era (to save on taxes), in post-GST era, would just need and have single CFA to cater to the NCR territory. Slowly this consolidation of CFAs will pick pace and may ultimately lead to elimination of CFAs altogether.

Now that pharma industry will not have to face any big-ticket challenges in 2018 (hopefully!), it will start to work on drawing out strategies to improve supply-chain efficiencies in the post-GST scenario.

Already, a very radical idea, though in its infancy, is being contemplated – which is 13 CFAs, with `13,000 crores in sales, 33 lakh sq ft warehouse space, and nearly 3,000 people, are planning to join hands and launch a new holding company, which will not only consolidate this business, but also enter into wholesale distribution (stockist, a level below). If it materialises, it would be significant, indeed! ◗ Distribution consolidation The second area which may witness a great churn would be consolidation of the pharma distribution. Let’s have a quick comparison of ‘Pharma Distributors’ in India and the US: In the world’s largest pharma market, top three distributors control over 90 per cent of the market, and among top 10 distributors, even the smallest distributor has $1 billion size. While in India, the situation is absolutely reverse, it’s highly fragmented. In India, distributors with more than `200 crores revenue, can be counted on fingers.

THE MAIN FOCUS

The pharma distribution in India, at distributors’ level, is ripe for consolidation. It has already begun, and in all likelihood, will gain momentum in 2018. Already a PE funded pharma distribution company, Ascent Health has started the consolidation process by acquiring distributors in Mumbai and Delhi Hence, the pharma distribution in India, at distributors’ level, is ripe for consolidation.

It has already begun, and in all likelihood, will gain momentum in 2018. Already a PE funded pharma distribution company, Ascent Health has started the consolidation process by acquiring distributors in Mumbai and Delhi.

Other policy challenge, though pharma industry may be well used to it, would be the continuous movement towards more price control. Only few days back, government again brought nearly 50 more drugs under price control. In 2018, there may be more such moves by the Government of India.

Earlier this year government banned large number of Fixed Dose Combinations (FDCs) on account of being irrational combinations, which was challenged by various companies in the court.

To subscribe: bpd.subscription@expressindia.com

As a corollary to this decision, interestingly, recently a case was filed before the Delhi High Court. The petitioner (association of dermatologist) requested the court to curb the approval and sale of a number of corticosteroids that are prescribed for treating a number of derma related ailments including skin inflammation, itching, fairness and pigmentation. The court has asked the central government as well as the Central Drug Standards Control Organization (CDSCO) to respond to the petition.

This case is a throwback to the earlier cases already going on, and which are in final stages of hearing at Supreme Court. In a way, the new case supports the government point. What it means is that even some section of the medical fraternity is questioning the indiscriminate launch of

FDCs. So, it wouldn’t be surprising that excess of the past will be cleansed through more such administrative or judicial actions.

Another focus of pharma companies in the coming year, to grow faster and profitably, would be on increased R&D spend, but targeted spends on speciality drugs, niche molecules and complex therapies such as injectables, inhalers, dermatology, controlled-release substances and biosimilars. So, we have companies working on NDDS like painless injections, or focussed exclusively on one therapeutic segments like CNS, derma, women’s health and so on.

Clearly, the focus would be on niche spaces and deep presence and differentiated offerings in the chosen domain

In a nutshell Though domestic market will

continue its growth path, in 2018, reaching its peak growth rate of 13-15 per cent will still take time. There will still be few growth pressures. The key trends would be: ◗ Domestic market will continue to see regulatory pressures in the form of DPCO or FDC banning ◗ Companies would have to explore and find their niche ◗ As in global market, domestic companies will have to decide their niche, be it therapeutic wise, or specific aspect of R&D, to secure their future ◗ Consolidation of pharma distribution, especially at distributors level, will gain pace ◗ In the post GST scenario, supply chain efficiencies would improve, and 2018 would be the harbinger of this change A recent article, mentioned that experts at Pantone (a ‘colour specialist’ organisation), chose ‘ultra-violet’ to be the colour of 2018. And this colour, according to Pantone Colour Institute, stands for originality, ingenuity, and visionary thinking; it’s a colour found in the cosmos, it stands for wellness movement (amethyst crystals), and finally it’s one of the most complex colours! In a sense, it truly represents what Indian pharma is all about, its challenges, or what it needs to do going forward. May be the road to bright future for pharma is paved with ultra-violet pebbles!

EXPRESS PHARMA

19

January 1-15, 2018

cover )

Tracking biosimilar trends In an insightful article, Debayan Ghosh, President & Founder, Epygen Biotech, highlights that biosimilars bear the potential to rationalise spending on drugs in developed economies and provide access to this critical driver of societies in the developing world

T

he Indian pharmaceutical industry is likely to be in the top 10 global markets by value by 2020 because of the healthy growth in the industry. It is estimated that by 2022, small molecule pharma drugs growth curve will be taken over by biotech drugs.

Latest technologies like real time data sharing, smart devices, mobile health and innovations in health insurance and diagnostic technologies have helped the industry to surpass the provision of healthcare services. Shaping up the overall region, there have been many regulatory interventions and amendments in the past couple of years that pharma companies must consider as they plan their future strategies. On the other hand, biotech industry in India seems to be getting bullish with robust regulatory framework being laid down in line with the

cal products drop off the patent cliff and new breakthrough biologics get approved.

top of the world and biotech giants like Biocon making foray in the US oncology heartland with one of the most potent biologics in the present times.

According to PwC report: Pharma 2020; India’s pharma industry looks set for a solid long-term growth. It is already ranked 14th in the global league table, with sales of almost $19 billion in March 2009. However, PwC estimates that it will rise to approximately $50 billion by 2020 – a 163 per cent rise in the span of 11 years, which is surely going to be surpassed.

Pharma vs biotech, a five years outlook It is estimated that biotechnology drugs will continue to rise, contributing to 50 per cent of the top 100 pharma sales by 2022. The biologics climb is expected to continue as novel biologic blockbusters keep enter-

Biosimilars

ing the healthcare market. The penetration of biotech products is set to increase from a 24 per cent market share in 2015 to 29 per cent in 2022. According to the latest forecast, in 2022, 50 per cent of the value of the top 100 products will come from biologics as established chemi-

US FDA defines biosimilars as — A biosimilar is a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

History is going to repeat itself. In the US, generics accounted for 86 per cent of all dispensed retail prescriptions in 2013. This saved their economy around $200 billion.

Cost savings, affordability and access becomes tantamount for biologics, being pricey in the

TABLE 1: GAP CLOSES BETWEEN SMALL MOLECULE CHEMICAL DRUGS AND BIG BIOLOGICAL MOLECULES BY 2022 SOURCE: EVALUATEPHARMA REPORT, MAY 2017

20 EXPRESS PHARMA January 1-15, 2018

first place. While many biologics are addressing significant unmet medical needs, they are unaffordable to many. Some of these therapies cost upwards of $100,000 per treatment course on an annualised basis. There is no doubt that biosimilars bear the potential to rationalise spending on drugs in developed economies and provide access to this critical driver of societies, in the developing world.

As per Assocham, the biosimilar opportunity is mounting as novel biologics continue to go off patent: As per Evaluate Pharma, around $23 billion biological novel products sales are at risk in 2019 alone, from monoclonal antibody technologies alone in the area of breast cancer and rheumatoid arthritis.

Some technology stats: Around 1,500 follow-on biopharmaceuticals are in development

(

THE MAIN FOCUS

TABLE 2: NEARLY $100 BILLION SALES TO COME FROM TOP 3 BIOTECH DRUG COMPANIES IN 2022 SOURCE: EVALUATEPHARMA AUGUST 2018 REPORT

FIGURE 1: BIOSIMILAR OPPORTUNITY IN $ BN SOURCE; ASSOCHAM WHITE PAPER-JP MORGAN

today, including more than 750 biosimilars. These pipeline products cover more than 150 reference products (nearly all of which are recombinant). In terms of regulatory status, nearly currently 350, are in preclinical development.

Indian biosimilar research R&D expenditure for biosimilar development in India increased

substantially to $1.4 billion during the year ended March 2015, a 28.8 per cent increase from $1 billion in the previous year.

[Source: OPPI November 2015Assocham]. This increased R&D expenditure is results from the engagement of lifescience companies from large biopharma, major generic companies, young biotech JV ventures and start-ups developing skills

To subscribe: bpd.subscription@expressindia.com

BIOSIMILAR TECHNOLOGIES UNDER DEVELOPMENT

for biosimilars manufacturing.

It is reported that there are more than 10 companies in India, genuinely developing biosimilars for the highest selling monoclonal antibodies of the world.

One very important aspect of the biosimilar business is that, it certainly is not everyone’s cup of tea. That is why only 10-15 companies in India truly

Types of products

Number of products

Cancer treatments

418

MAbs, fragments

261

Epoetin alfa

85

Interferons (alfa)

60

Neupagen (filgrastim)

59

Insulin and analogs

51

Rituxan (rituximab)

50

Herceptin (trastuzumab)

38

Somatropins

34

Enbrel (etanercept)

31

Humira (adalimumab)

30

Interferons (beta)

27

Avastin (bevacizumab)

25

Neulasta (pegfilgrastim)

24

Remicade (infliximab)

17

Lantus (insulin glargine)

10

made a footing into this segment, when several hundred small molecule pharma companies crowd the floor. While the global biopharma industry has made significant progress in mastering the complex science behind manufacturing a biosimilar, it still remains a hurdle for Indian companies, who tradi-

tionally had been focussing on scales of producing generic drugs, but missed out on the advancements in the industry. No doubt, with a number of Indian companies now jumping into the biosimilar segment, taking special cognisance of the critical technology aspects, the barrier Continued on Page 23

EXPRESS PHARMA

21

January 1-15, 2018

cover ) Poised for a strong growth Gaurav Agarwal, Director, Singhi Advisors, throws light on the trends in the new year and opines that Indian pharma companies would continue their M&A spree on foreign shores in 2018

T

he year 2017 for Indian lifesciences sector started on the back of a strong M&A momentum of 2016 that witnessed 51 deals with aggregate disclosed deal value of $4.6 billion. And the deal closure was quite well spread with the disclosed transaction value, outbound and inbound activity, standing at $2.1 billion each, which is a rare coincidence indeed.

While the volume of domestic deals was high (21 deals), their value was smaller at $342 million.

The steam seems to be continuing, albeit slowly. Until October 2017, there have been 27 M&A deals in the pharma and healthcare sector, valued at $719 million. Some of the noteworthy transactions were Lupin’s $150 million acquisition of Symbiomix Therapeutics, Eris Lifesciences $500-crore acquisition of Strides Shasun’s branded generics business in India, and Torrent’s `3,600crore acquisition of Unichem’s branded formulations business in India and Nepal.

Interestingly, the last two deals in the above list were both in the domestic segment and were done to consolidate market positioning of the acquirer. Eris went for their fourth and the largest acquisition in the past 18 months to break into the league of top 25 companies in the Indian pharma sector with a market share of more than one per cent. It also strengthened the company’s position in the CNS (puts it among the top 10) and gastro-intestinal therapies segments.

Likewise, Unichem’s deal will provide Torrent access to leading brands such as Losar,

22 EXPRESS PHARMA January 1-15, 2018

Indian firms need to differentiate through higher amounts on R&D spend. Drug makers will have to develop complex technologies to deliver drugs and new formulations to create a specialty niche portfolio with less competition Unienzyme, Ampoxin, Telsar and Vizylac. In its existing key therapies, Torrent’s market share in cardiology, CNS and gastrointestinal therapies will increase by two per cent each.

The shopping spree of cash rich Indian companies targeting foreign firms should continue in 2018, though it is likely to be much more cautious. US remains the largest pharma market by far. However, Indian generics pharma companies have increasingly witnessed

erosion in margins in their US business, not only due to heightened competition among Indian players, but also because of consolidation among US pharmacy chains as well as deliberate attempts by the USFDA to bring down prices of generics.

Indian pharma companies exported over $16 billion of generic drugs in 2016, making the country the largest player in this segment. According to estimates, there are over 6,000 drug makers in India and it seems that many of them have

rolled up their sleeves to be the most cost competitive exporter for plain generics. Business from the US adds incremental revenues for them, so they don’t mind offering steep discounts upfront.

Agencies in the US are also doing their bit to bolster competition among generics manufacturers to bring down prices. In the first half of 2017, around 40 per cent of new approvals in the US were granted to a wide set of Indian firms. This is against 35 per cent just a year earlier.

As the smaller Indian manufacturers grow stronger, the US FDA is likely to take advantage by handing out approvals at a faster pace specifically favouring generic drug applications for products that have few competitors. This way they can drive down prices further.

The most pressing need for leading Indian manufacturers is to differentiate through spending much higher amounts on R&D. Successful drug makers will be those who can develop complex technologies to deliver drugs and new formulations to create a specialty niche portfolio with less competition. This very thought process is likely to be reflected in potential outbound M&A transactions in 2018 where I believe the focus would be on selective international companies with strong R&D pipeline of complex niche generics. Laying hands on specialised manufacturing assets, particularly in injectables, is also not ruled out. Also, with around $90 billion worth of biosimilars going off-patent in the US and Europe in the next 10 years, there will be substan-

tial interest to acquire selective portfolios.

Despite uncertainties arising from potential regulatory price controls, domestic manufacturers should continue following the inorganic route to strengthen their position. It is a large growing segment. The Indian Pharmaceutical Market (IPM) clocked `115,202 crores, of which the retail sector was valued at `96,997 crores as of MAT August 2017. Rising pollution levels and increasing incidence of lifestyle diseases have made therapeutic areas like diabetes, cardio, CNS, derma, gastro etc grow consistently at early double digits. Domestic market thus offers attractive opportunities to companies with differentiated portfolios in many of these segments.

The sector should also draw interest from private equity players since it is non-discretionary and poised to grow strongly. Case in point is Samara Capital’s pharma platform that acquired the Indian pharma business of South African drug maker Adcock Ingram Holdings in April 2016.

Later, in October 2017, the fund further acquired anti-infective brands from the Swiss pharma major Novartis in order to create a much stronger women's healthcare portfolio.

Finally, with market cap of most Indian pharma companies having halved, consolidation among the generic players is also likely.

The pace of such consolidation will, however, not only be driven by business fundamentals, but also factors like extent of fatigue, succession issues and wealth diversification.

(

THE MAIN FOCUS

Continued from Page 21

Tracking biosimilar... from a technological standpoint has significantly come down.

However, it will continue to remain an important consideration for any newcomer trying to enter this segment, who does not have background in fermentation, protein purification and DSP and the associated regulations. In near future, it is critical that these biosimilar aspirants streamline their regulatory compliance in wake of the new stipulations, with respect to the producing and processing of molecules as well as clinical trial data. This will open up the golden gates to a much larger global biosimilar market, potential changing the game of Indian biosimilars. Challenge will now evolve beyond developing

a biosimilar molecule that is a fingerprint copy of the original, to achieving a bio-better, more efficient and safer protein for patient with a further improved profile, maintaining all the proofs of biosimilarity, with a key focus on optimisation of processes and costs without compromising time to market.

Companies in the biosimilar space must consider the following points: ◗ How will you acquire the desired success amongst unmatched strategic and policy uncertainty in the region? ◗ How will you phase and transform from volume to value? ◗ How will the new age realities emerging from artificial intelligence and advanced analytics

FIG 2: EVALUATE PHARMA DATA ON NOVEL BIOTECH PATENT CLIFF

improve your R&D and commercial outcomes?

Further, to prioritise the value of a drug over the volume in the years to come, it is impor-

tant to consider multi-stakeholder platform. This could be a structured collaboration between manufacturers, payers, healthcare systems, data

providers and adjudicators that are designed to explore valuebased contracts in a safe forum, paving path to the new dawn of healthcare.

The Standard of Comparison

Pharmaceutical Grade Crystalline, Spray Dried, Anhydrous, and Inhalation Lactose • For more than 70 years, we have delivered the industry's most extensive Lactose portfolio

www.SheffieldBioScience.com

• The original patent for Anhydrous Direct Tabletting (DT) Lactose • Batch to Batch Consistency • Global technical service, regulatory and application expertise to ensure regional and global market compliance

To subscribe: bpd.subscription@expressindia.com

Registered Office Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identification Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

EXPRESS PHARMA

23

January 1-15, 2018

cover ) I N T E R V I E W

‘Patients and consumers will be looking for convenient and intuitive packaging formats’ The future will see more prescription products in multi-dose preservative-free formats, both in highly regulated and less regulated markets. Matthias Birkhoff, VP Business Development, Aptar Pharma and Dr Degenhard Marx, Director Scientific Affairs, Aptar Pharma Consumer Health Care Division, reveal more in an e-mail interaction with Viveka Roychowdhury

What are the pain points experienced by patients using ophthalmic medications?

There are several factors which contribute to eye problems, especially for elderly patients with impaired dexterity or vision.

Many complaints relate to the eye drop primary packaging; sometimes patients find the bottle or container hard to open, or it is difficult to accurately deliver a drop into the eye. This issue varies from brand to brand, but really depends on the packaging design and the material with which it is made.

For example, the actuation force required to generate a drop from single-dose and multi-dose droppers may range from 4-5 N to 45 N. Another issue is difficult dosing schedules. If a patient is taking more than one medication, it could potentially be paired with unrealistic dosing recommendations. Although it is recommended for patients to wait five to ten minutes between eye drop administrations, this is not always the case and patients tend not to adhere. They may also confuse the order in which the medications are meant to be administered.

This issue can be addressed by simple,

24 EXPRESS PHARMA January 1-15, 2018

knowledge. Pharma companies have responded by manufacturing preservative-free eye drops, mainly in single dose dropper availability.

Matthias Birkhoff, VP Business Development, Aptar Pharma

visualised dosing schedules or a prescription of combination products, if available and affordable. It is also important to consider the side effects related to the medication. Side effects may be caused by the active ingredient, and in many cases come from the preservatives used, particularly in common multi-dose bottles.

Benzalkonium chloride is used for most preserved eye drops.

Clinical evidence suggests that especially during longterm treatment, or if two or more preserved eye drops are used, side effects can accumulate and become severe. This is now wellrecognised and common

What are the levels of patient compliance observed with eye care treatments?

Examining the literature for non-compliance and adherence, a wide range of patient compliance is reported. Serious studies report non-adherence of patients somewhere between 23 per cent and 60 per cent.

In most cases, this data is based on questionnaires filled in by patients, which may not be always reliable, as the data may be better than reported, or possibly worse. Studies with intelligent monitoring technology may generate much better data. Besides this, there are several influencing parameters, such as severity of symptoms, education and training of patients, and social environment. Nonetheless, it is clear that non-compliance is a real problem that should be addressed by all stakeholders.

What role does the choice of a packaging format play when it comes to solving patient pain points and improving patient

Dr Degenhard Marx, Director Scientific Affairs, Aptar Pharma Consumer Health Care Division

adherence?

The packaging system plays a key role and many issues can be addressed if the right combination of dropper and formulation is used. The packaging supplier needs to consider critical points early on during the development of a new packaging design.

Claims of easy handling and other advantages of a new packaging system should be based on user studies with patients. However, this is just one part of the story. Any new packaging system needs to be compatible with the formulation to keep it safe and effective.

Single unit-dose systems which are free of

preservatives do not tend to be easy to handle; they are often difficult to open or hard to squeeze. Furthermore, the formulation is not always easy to handle during the blow-fill seal (BFS) process in examples such as temperature-sensitive products or interaction with packaging material.

The side effects associated with preservatives, such as ocular surface changes, discomfort, inflammation and more, can be avoided by using novel multidose preservativefree packaging formats, such as Aptar Pharma’s Ophthalmic Squeeze Dispenser.

Multi-dose systems offer a range of technologies to tackle the preservatives issue, including pure mechanical systems, valve systems, filtration systems, the use of oligodynamic elements and others. For any system, the major challenge is to demonstrate the microbial integrity of the packaging.

Since the vast majority of patients receive little or no training at all, any design should be intuitive and as close to existing solutions as reasonably possible.

What are the guidelines that manufacturers of preservative-free

( ophthalmic applications need to comply with on the microbiological safety side?

European Authorities support the use of preservative-free eye drops whenever possible, yet to the best of our knowledge, there are no specific guidelines for preservative-free multi-dose presentations in place. The reason may be that this is a rather new technology and establishing new guidelines is a lengthy and complicated process.

On the other hand, ophthalmic preparations must be sterile. The bottle content has to remain sterile during the entire life of such a dropper, especially while in use. Sterilisation of the

packaging components, sterile filling and line qualification, and sterility testing strategies are wellestablished in the pharma industry and can be applied to preservative-free products. Therefore, the wheel does not need to be reinvented. The preservativefree technology does not need an unfamiliar manufacturing environment, which is a clear advantage.

Not using any debatable additives, Aptar Pharma’s Ophthalmic Squeeze Dispenser allows for an easier pathway through the regulatory approval process as compared to competing systems. Some of these systems release silver ions into the fluid pathway, which

To subscribe: bpd.subscription@expressindia.com

interact with the formulation to inhibit microbial growth.

For good reason, regulatory bodies such as the US FDA ask sponsors to explain how the silver is incorporated into the delivery system. The agency will want to know whether the silver leaches out into the formulation and, if so, what it does to the patient.

The generation of additional data required to answer these questions certainly adds a level of complexity to any regulatory filling process.

What are the latest trends to watch out for in 2018 in intuitive eye care drug delivery formats?

Our population is ageing rapidly. Consequently, with the increasing numbers of

THE MAIN FOCUS

elderly people, the occurrence of ophthalmic diseases will stimulate demand for ophthalmic drugs. The future will see more prescription products in multi-dose preservativefree formats, such as Aptar Pharma’s Ophthalmic Squeeze Dispenser, both in highly regulated and less regulated markets. In particular, products for the treatment of increased intraocular pressure will be using this technology, as any long-term treatment should come without the potential side effects of preservatives.

In parallel, patients and consumers will be looking for convenient and intuitive packaging formats which will not require too much learning

and, not to mention, too much space.

Could you give examples of the successful use of Connected Health within the field of drug delivery systems for eye care applications?

The first clinical studies have been initiated in Europe utilising connected devices.

The idea is to replace assumptions with real-time data in order to save time and effort for clinicians as well as improve study accuracy. This is a relatively new technology though, so it will be very interesting to watch this evolve in the near term. viveka.r@expressindia.com

EXPRESS PHARMA

25

January 1-15, 2018

cover ) Digitech: Revolutionising healthcare Vineet Singhal, Country Head, Shire India, touches on the trends predicted to change the healthcare industry in the next decade and how companies are planning their go-to-market strategies accordingly

A

n exciting wave of change is revolutionising the healthcare industry. We have already stepped into a connected world and will see further digital transformation in the coming years. Healthcare is going mobile, with mobile health app adoption rates higher than ever. Nowadays, consumers and patients are not only using their smartphones and smartwatches (amongst other interconnected devices) to monitor their health, but also receive expert diagnoses from remote locations in the comfort of their own homes. We are set to see artificial intelligence, augmented reality, internet and robotics playing a huge part in the healthcare sector. In the coming years, we also expect an increase in public-private partnerships that will make healthcare more accessible to patients. This will require government bodies and private organisations to come together and work collaboratively to bring system innovation into the healthcare sector subject to

26 EXPRESS PHARMA January 1-15, 2018

applicable laws and policies.

Tackling challenges We are the champion for rare disease patients and have a long-term commitment to the India market. Currently, the biggest challenge is the lack of awareness and priority given to rare diseases and other specialised conditions. We are therefore focussing on three key areas: firstly to increase the visibility of these conditions amongst the medical community; secondly to improve the means of diagnosis for rare diseases, and lastly to ensure therapies can be accessed by patients.

We are making a concerted effort to nurture an ecosystem that supports patients with rare diseases and ensure these challenging and life-changing conditions are effectively treated. It is important to create more conversations about the issues surrounding rare diseases at various levels, including patients, doctors, the medical community and policymakers. Shire will continue to

work with all stakeholders to help make rare diseases a public health priority and improve their diagnosis and management in India – from undertaking patient outreach to awareness programs for the

medical community, and engagement with doctors and policy influencers. In addition to the increased awareness around the disease, diagnosis, and management of these life-affecting conditions, we strongly advocate the development of national policies that support improved access to healthcare and health innovations for people with rare diseases.

We believe that government is making positive steps to improve standards of care and healthcare infrastructure to ensure healthcare is more accessible in India. For example, there has been an increase in the provision of haemophilia treatment around the country and this has increased from just three states 10 years ago, to 22 states today. Government is playing a pivotal role in patient’s disease journey, helping to ensure patients with haemophilia do not suffer from a lack of access to the clotting factors they need.

We are committed to bringing our innovative products

and support services to patients affected by rare diseases in India and will continue to work with all stakeholders to help make rare diseases a public health priority and improve diagnosis and management– from undertaking patient outreach to awareness programs for the medical community, and engagement with doctors and policy influencers.

Go-to-market strategy in India for FY17-18 It is estimated that one in 20 Indians is living with a rare disease, that’s around 70 million people across the country.

These figures do not reflect the untold number of family members and friends who watch a loved one struggle with health challenges that, in many cases, cannot be adequately addressed today, especially considering nearly half of the time these loved ones are children.

At Shire, we meet that challenge head on by committing ourselves fully to the fight against rare diseases. We believe that creating a supportive

( environment for people with rare diseases requires a comprehensive approach encompassing awareness, education, diagnosis, and infrastructure to access the right treatment options. For example, leveraging our heritage and experience in haemophilia, we are collaborating with healthcare professionals, healthcare providers, patient organisations and other stakeholders to expand haemophilia education at the national and regional level, with a goal of improving under-

We are set to see AI, augmented reality, internet and robotics playing a huge part in the healthcare sector standing and knowledge of the disease, encouraging early diagnosis and enhancing the standard of treatment and care. Soon, we will be introducing a haemophilia support programme to provide assistance to patients and their caregivers.

This includes: ◗ High-quality information to help disease understanding and its daily management ◗ Education and awareness on symptom, treatment protocols ◗ Injection and infusion training by nurses ◗ Physiotherapy and homecare assistance ◗ Coaching and counselling to support everyday living with haemophilia. Well being programmes to help alleviate the burden of symptoms ◗ Care coordination (by acting as the primary contact for multiple stakeholders) We are working relentlessly to expand our footprint to sup-

EXPRESS PHARMA

27

January 1-15, 2018

port more patients in India. We are focussing on other rare diseases too and will be soon launching products for lysosomal storage disorders. Today, our pipeline is the deepest and

most innovative in Shire’s history. We are conducting over 46 research programmes globally and have more than 40 clinical trials underway. We are also using strategic partnerships, ac-

THE MAIN FOCUS

quisitions and licensing globally to seek out new innovation opportunities, further develop our core therapeutic areas and expand into adjacent diseases, to create the most value for our

patients and partners. We are and will continue to strive, to be the partner of choice for companies seeking to develop and commercialise innovative therapies for rare diseases.

cover ) Ramping up R&D— Key to success Rahul Dev, Vice President India, Datwyler, highlights that R&D is of key importance for pharma companies to leverage opportunities and face challenges as new technologies and developments determine the trends in the markets

T

he healthcare industry is consistently geared towards improving the future with new solutions.

Developments and new products are being introduced to the market fast. Those new developments and products often indicate clearly in which direction a market or industry is headed.

For international industrial suppliers like Datwyler, business focus and new developments are defined by current opportunities and industry trends arising in the market. These trends are typically anticipated due to a company’s longstanding experience and expertise. This is especially important in the highly competitive healthcare market, in which pharma and medical manufacturers rely on partners who can assist them in mastering the challenges of the global healthcare industry and enabling them to recognise their full potential. This includes in-depth engineering competence regarding innovative technologies as well as technical knowledge transfer. In addition, close collaboration with partners and customers and their respective research and innovation centres is very important and can make a big difference in how quickly companies can react to new developments and particularly how fast they can launch new innovative products.

This collaboration can mutually benefit both parties and create access to new ways of treatment.

Identifying trendsetting market developments There are several developments which Datwyler identified as important and interdependent trends in the pharma market.

One important field is the sector of digital health. Particularly, wearables which allow new ways

28 EXPRESS PHARMA January 1-15, 2018

Next to generics, R&D will become a major stronghold for India in the future.

Many pharma majors are merging with or acquiring Indian pharma companies and are heavily investing in R&D of administrating and selfadministrating drugs are key developments to improve patients’ lives. For e.g., wearables can create a big difference in the way in which diabetes patients receive their treatment. The devices used to treat diabetes are changing and will continue to do so – both to facilitate drug administration and to provide more comfort for the patient.

Patient safety and comfort are at the core of the developments that are happening in the field of digital health, particularly when looking at patients in emerging markets who may not yet have access to the facilities and infrastructure of the Western world. Safe and secure access to and administration of

drugs will be even more essential in the future.

Additionally, wearables will also play a big role when it comes to monitoring patients and their conditions. This allows for a wholesome approach in diagnosing, monitoring, medicating and drug administration, which will become increasingly important to achieve goals in global health.

To make an all-encompassing development possible in the field of digital health, it is of key importance to invest in research and development and the respective facilities. Whilst those are often still located in the Western markets, emerging markets like India have been gaining importance as lo-

cations for innovative R&D centres.

India — A key market for R&D India is one of the most important healthcare markets and it keeps gaining relevance. The Indian market sees the most US FDA approved products worldwide and this development is more than likely to continue.

While the Indian healthcare industry is currently strongly focussing on generics and biologics, the inclination of international companies to set up R&D facilities in the market is strong. Indian manufacturers see this as an important step to further excel in business and concentrate on the production

and development of high-end products.

This trend is here to stay as global companies have started to recognise the market’s potential.

Many pharma majors are merging with or acquiring Indian pharma companies and are heavily investing in R&D. Production used to be the main focus, but now a substantial amount of the annual profits is going into R&D investments.

Many of the major global players are also setting up own R&D facilities in India. Next to generics, R&D will become a major stronghold for India in future.

Datwyler’s new expansion of its existing facility in Pune will accelerate the company’s efforts to cater to local customers and suppliers with high-end products. The newly extended facility will produce according to the state-of-the-art first line standard that incorporates cleanroom manufacturing on a level that exceeds the most stringent quality standards of the European and US regulatory authorities and is certified to ISO 15378.

In summary, companies are taking the important step of closely evaluating the market and anticipating trends and new developments to shape the future of healthcare and improve patients’ lives. Digital health and the ways it allows new forms of diagnosing, monitoring and medicating patients is a major trend which can transform the industry. R&D is of key importance to face the challenges which new trends and products are bringing to the market. Emerging markets increasingly play a big role as locations for research and development and will therefore also further push the overarching goal of global health.

(

THE MAIN FOCUS

Anew era in pharma business Amit Chopra, MD & VP/GM, Thermo Fisher Scientific, India and Middle East, explains how technology can help companies comply with regulations and meet customer expectations

I

ntroduction and increased investments in R&D for developing new and technologically advanced products, implementation of regulations that mandate elemental analysis of pharma and healthcare products, and growing awareness amongst manufacturers as well as consumers due to conferences, meetings, and congresses, have influenced the pharma analysis market. As per Grand View Research report, the global elemental analysis market size is valued at $ 1.20 billion in 2016 and is projected to grow at a CAGR of 6.2 per cent.

Elemental analysers are used for organic, inorganic, qualitative and quantitative estimation of heavy metals and detecting traces of catalysts in a sample. In pharma samples, inorganic elements are analysed in range from heavy metals to traces of catalysts. In 2016, analysis for inorganic elements held the largest market share which can be attributed to guidelines that provide allowable limits of heavy metals and trace metals in pharmacopoeias of various countries. Further, technologies for elemental analysis are segmented into Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), combustion analysis and other electroanalytical and chemical methods.

ICP-MS is an analytical technique used for elemental determinations. It was commercially introduced in 1983, and has gained general acceptance in many types of laboratories. Geochemical analysis labs were early adopters of ICP-MS technology because of its superior detection capabilities, particularly for the rare-earth elements (REEs). An ICP-MS combines a high-temperature ICP source with a mass spectrometer to convert the atoms of the elements in the sample to ions. These ions are then separated and detected by the mass spectrometer. Until recently, the numbers of AAS (Atomic Absorption Spectroscopy), ICP-OES and ICP-MS installations in pharma companies were lim-

ited and restricted to only major companies. An ICP-MS has many advantages over other elemental analysis techniques such as atomic absorption and optical emission spectrometry, including ICP Atomic Emission Spectroscopy (ICPAES), including: ◗ Detection limits for most elements equal to or better than those obtained by Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) ◗ Higher throughput than GFAAS ◗ Ability to handle both simple and complex matrices with a minimum of matrix interferences due to the high-temperature of the ICP source ◗ Superior detection capability to ICP-OES with the same sample throughput ◗ Ability to obtain isotopic information.

Increase in research for the development of technologically advanced elemental analysers, upcoming regulations that mandate elemental analysis of finished medical products, USP guidelines and limits for elements in pharma compounds have led to an upsurge in applications of elemental analysis in healthcare and seize largest share in the pharma business.

While having the right technology is a critical aspect, customers also need to focus on other things like usage of high purity trace acids, NIST certified single/ multi element standards, high purity low ion content water, certified plastic ware that guarantee leach proof material of construction for use in sample preparation and storage play a crucial role in legislative compliance efforts.

The USP General Chapters which was initially planned for implementation in 2013 was deferred first in 2014 and subsequently to 2015. As pharma and control testing labs gear up to comply to the new norms that will come into effect in January 2018, there is a heavy dependency on the range of ICP-OES and ICP-MS instrumentation products and services that become crucial for pharma scientists, enabling users to meet the future legislative requirements while delivering accurate and repeatable results. The proposed USP chapters mark a new era for the analysis of trace elemental impurities in pharma products and the industry must get equipped for the change.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

29

January 1-15, 2018

cover ) I N T E R V I E W

‘Drug manufacturers will turn to solutions that enable decreased coating times’ Vanessa Patrao, Marketing Specialist, Dow Pharma Solutions and Savindu Kudrigikar, Business Head, South Asia, Consumer Solutions, in an interaction with Swati Rana, talk about solutions that will dominate the pharma industry in 2018 Which technologies will dominate 2018? How will they be in tune with the evolution of the pharma sector, globally and in India?

Technologies that offer functional solutions to address the industry needs for bioavailability, productivity and controlled release will dominate the pharma landscape in 2018.

Dow can help customers meet these needs with its portfolio of offerings for solubility enhancement such as Affinisol HME and SDD; for productivity such as Methocel DC2, Methocel K200M, Methocel VLV, Ethocel High Productivity and for controlled release such as Methocel CR, Ethocel and Polyox resins. ◗ Solubility enhancement As the number of low solubility APIs in development pipelines and regulatory standards in APIs increases, techniques to achieve solubilisation of sparingly soluble drugs is a top priority for drug manufacturers. By recognising the importance to tailor the drug solubility enhancement polymer to the characteristics of the drug candidate and the production, market potential exists for companies to create technologies that contain more polymer tailoring options, increase manufacturing capacity, include a wider processing window and enhance solvent choice flexibility.

The adoption of solubility enhancing polymers, such as Dow Affinisol HME and SDD to

30 EXPRESS PHARMA January 1-15, 2018

Vanessa Patrao, Marketing Specialist, Dow Pharma Solutions

address the solubilisation performance required by insoluble APIs will be a growing trend in 2018 to address the needs of poor bioavailability.

Formulated via SDD or HME, soluble polymers are effective solutions to help maintain solid stable dispersion, inhibit API crystallisation and enhance solubility in extrusion applications without plasticisers. ◗ Productivity Drug formulators face increasing pressure to boost productivity as a result of healthcare cost pressure, aggressive pricing competition and the desire for process simplification. The industrywide pressure to lower costs through higher productivity and streamlined drug manufacturing operations poses an opportunity for technologies that decrease time in formulation stage and

reduces the manufacturing cost to save formulators time and money.

To increase productivity, drug manufacturers will turn to solutions that enable decreased coating times, help further slow the release of certain active ingredients and facilitate high speed dry powder layering process for multi-particulates.

Dow’s productivity-increasing excipients Methocel DC2, Methocel K200M, Methocel VLV, Ethocel High Productivity offer a seamless application in drug formulations, increasing speed to market and freeing up time for formulators to focus on other innovations. ◗ Controlled release Lastly, the need for controlled release technologies to optimise medication performance continues to experience significant growth.

As much of the new drug exploration is now based on biologics, new challenges arise from drug manufacturers as biologics contain a unique set of delivery issues with a large issue being stabilisation. Now usually only amenable to needle delivery, pharma companies who dedicate time and resources to explore delivery options for biologics and create technologies to facilitate controlled release could cause disruption in the pharma industry.

Drug manufacturers will be drawn to companies, like Dow, which offer a one stop shop for controlled release solutions like Methocel CR, Ethocel and Polyox resins. These are

Savindu Kudrigikar, Business Head, South Asia, Consumer Solutions

versatile solutions that can be plugged into a wide range of formulations, which presents an opportunity to secure customer loyalty.

How these technologies will become solutions to help companies comply with new regulations, customer/patient expectations, etc.

Regulators have increased the amount of Good Manufacturing Practices and risk assessments for excipients in particular. For example, the European Union (EU) guideline that became effective in March 2016 for more formalised risk assessments need to be conducted on a regular basis.

This shift is not limited to the EU, as we’ve seen risk assessments become more of a standard globally as a tool in managing raw material and supplier qualification.

The global supply chain

is complex with regulations varying by region. Dow works with its customers to find ways to meet these regulatory challenges across multiple regions. For excipients there is particularly more diligence when they fall under drug or API regulations. For example, several countries have requirements for a specific amount of remaining shelf life for imported drug products.

Since these regulations don’t distinguish excipients from APIs or the finished drug product, compliance often does not have a defined shelf life as compared to most APIs and drug products. The need for open communication between raw materials supplier and formulator is key to achieving regulatory and quality standards. This is to ensure materials suppliers not only know the drug formulation goals but also its end product use.

Consistency in meeting high product performance standards is a hallmark of quality control and meeting regulations. Dow Pharma Solutions products are backed by testing, analytics and formulation expertise to help customers create the best end use application. With each of its pharmaceutical solutions, Dow provides: ◗ Outstanding global technical support ◗ An extensive manufacturing footprint across multiple regions ◗ Strong business continuity for reliability of supply ◗ Outstanding standard of

( quality, consistency and manufacturing excellence ◗ Regulatory support including full Quality by Design sample set Dow Pharma Solutions supports the formulation and scale-up activities to develop more robust drug formulations.

Our deep understanding of the structure and property fundamentals is critical to the successful use of cellulosic polymers. With our experience in analysing chemical structures and rheology and our vast knowledge in manufacturing specialty excipients, we help you reduce development risks and support you through all stages of drug development.

What are the new launches from Dow Pharma solutions?

Dow’s differentiated solutions that address the pharma industry’s most pressing drug development challenges include: ◗ AFFINISOL Hypromellose Acetate Succinate (HPMCAS): Uniquely tailored to address the solubilisation performance requirements of active pharma ingredients through stable solid dispersion and inhibition of active pharmaceutical ingredient (API) crystallisation. AFFINISOL HPMC HME provides improved thermal properties conceived for hot melt extrusion.

The newest grade that was launched this year is AFFINISOL HPMCAS High Productivity, its innovative properties to facilitate higher solids content for increased throughput while maintaining optimal solubility, earned the technology a nomination for CPhI’s Pharma Awards 2017. ◗ METHOCEL Hydroxypropyl Methylcellulose (HPMC) polymers: Water-soluble polymers that are designed to offer consistent drug release performance. ◗ ETHOCEL Ethylcellulose polymers: High productivity polymers optimised for dry powder layering processes that can coat 40-60 per cent faster than multi-particulate coating technologies. ◗ DOW CORNING topical

EXPRESS PHARMA

31

January 1-15, 2018

excipients: Innovative range of topical ingredients specifically developed to facilitate patient compliance, help improve aesthetic and increase formulation flexibility.

An estimated 70 per cent of APIs present solubility issues, which can significantly limit a manufacturer’s pipeline of drug candidates. In addition to providing innovative

THE MAIN FOCUS

product solutions, Dow’s Indian Engineering Center offers full formulation capabilities to help customers develop hot melt extrusion (HME) and spray dried

dispersion (SDD) technologies that enhance the solubility and bioavailability of oral solid dosage forms. swati.rana@expressindia.com

MANAGEMENT

Can Indian Pharma Inc find its lost mojo?

Ashish Prasad, Partner, Economic Laws Practice, Indian Pharma Inc will need to take stock of the current situation and chalk out a new path for growth

T

he Indian pharma industry has, over the course of the last few years, met with substantial headwind impeding its growth both in the domestic as well as the international markets. This can be attributed to a vast array of policy and regulatory changes both in India and internationally. While in India, pricing pressures, demonetisation and GST have been the main causes for a reversal of its growth rate, pricing pressures from key markets such as the US as well as global regulatory interventions have posed additional challenges. While the industry faces challenges, vast opportunities await the industry after it has readied itself for the challenges.

Pricing pressures in the domestic market are not likely to let up and can only be expected to increase. With healthcare standards being set high the world over and increasing cost of medicines, state intervention is bound to increase in order to provide widest access to healthcare.

The provision of quality and affordable drugs to its people is the mantra of every administration. President Trump’s administration has criticised the Pharma sector for its expo-

32

EXPRESS PHARMA

January 1-15, 2018

nential pricing and has sought to impose a Border Adjustment Tax (BAT). If made applicable to Indian companies, the prices of Indian drugs are likely to increase, making it more difficult for India to compete in a growing market.

Will these challenges keep India from realising its 2020 vision? India is irrepressible and our pharma industry has proved many times that when the going gets tough the tough get going. All it needs to do is introspect, reinvent, realign with new strategies, innovate and reorganise. Indian Pharma Inc. will need to take stock of the current situation and chalk out a new path for growth.

When existing practices have proved stumbling blocks, innovation has held the key to breaking the barriers to growth. Indian Pharma Inc, which has traditionally been a producer of generic drugs, must realise its research and development potential in order to stay ahead of the competition. The need for Indian firms to replenish their research and development budgets and participate in drug discovery and production of complex generics cannot be overemphasised.

Innovation in the pharma

Innovation in the pharma sector implies not only discovery of new molecules but also innovation in practices

sector implies not only discovery of new molecules but also innovation in practices. The industry must adopt new strategies which will facilitate such discovery with optimum utilisation of scarce resources.

The world is increasingly favouring open innovation, codevelopment and collaboration in research involving new alignments with the government, universities and leaders in particular fields of research to gain from sharing of knowledge and discovery. Such collaboration would help expeditious piecing together of the biochemical jigsaw thereby cutting down the time consumed in research and development. Acceleration of the pace of discovery will reduce cost of drug manufacture substantially thereby reducing the cost of drugs.

Innovation and partnership are thus the key to accelerated growth. Indian Pharma Inc. must forge partnerships in drug development as well as in drug marketing by entering into license agreements wherever possible to facilitate wider access to innovation.

For an industry which earns majority of its revenue from exports, competition must be welcomed and respected as it

would prepare the industry to meet quality concerns raised by the more demanding regulatory regimes such as that of the US. Repeated negative observations by the United Stated Food and Drug Administration (USFDA) on quality issues would only pose setbacks which Indian Pharma Inc can well do without. Indian Pharma Inc must take it as an opportunity to re-align its manufacturing practices with the most demanding regulatory regimes of the world to ensure standardisation. Global best practices must be adopted and internalised to ensure that they are followed more as a matter of principle than of necessity for both – the international market as well as the domestic market.

The industry can prepare to bounce back by reviewing its preparedness to combat the more long term regulatory and existential challenges. A review of the product portfolios and diversification would create better opportunities. As it poises itself for growth, the Indian Pharma Inc will gradually be moving from treatment to prevention and provision of total healthcare packages to a population which has increased access to healthcare.

Policy experiences of 2017 for pharma sector Krishna Sarma, Managing Partner of Corporate Law Group, gives an insight about the need to take positive learnings from the experiences of 2017 and design further policy actions in a more inclusive way in the next year CROWNED WITH the glory of being the 'pharmacy of the south,' the health of the Indian pharma industry seems to be on somewhat of a decline of late.

Once registering a healthy, near about of 15 per cent CAGR, the domestic market growth slowed down to near 11 per cent CAGR during the last five years.

Whereas the challenge of healthcare access in an economically diversified demography like that of India cannot be understated by any accounts, it is more often witnessed that the burden of healthcare access is disproportionately passed on to the pharma industry.

The current work in progress, the Draft National Pharmaceutical Policy 2017 (Draft NPP 2017) is a viable medium of infusing the fuel of growth into the pharma sector, albeit, if the draft policy addresses the right issues, and more importantly, with the right approach.

Unfortunately, the draft that was published and stakeholders comments sought seemed to be more central to issues related to price and affordability rather that aimed at the well being of the industry itself along with its ability to partner the govern-

ment in the endeavour to meet the unmet medical needs of the masses.

It is pertinent to note that the government, in its own admission, in the past has rightly held that access to medicines for the population and the economic well being of the industry, both has to go hand-in-hand and that the policy decisions on this subject must strike a balance between the two aspect of affordability of medicines and the industrial growth. During the recent past, this delicate balance seems to be getting more and more away from the aspect of industrial growth.

The year that it was, mounting pressures on the pharma and medical devices industry in form of price controls has been the flavour of 2017. A classic example is the case of price fixation of cardiac stents during early 2017. What was more serious was the fact that on one hand the government had capped the prices of stents, sometimes possibly at a commercially unviable level and on the other hand it also prohibited manufacturers from discontinuing some of the brand that became loss making for them.

Needless to state, compelling an

To subscribe: bpd.subscription@expressindia.com

industry to do business at losses sends extremely negative signals for investments for future growth.

The pricing pressures in the base businesses and government’s initiative towards affordability is expected to continue.

This year also witnessed the government’s incessant attention to generic medicines. Be it by making generic prescription mandatory for doctors through amendment in the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 or changes in labelling regulation under Drugs & Cosmetics Rules 1945 for printing proper name of drugs in bigger font sizes, the govern-

ment has been adopting various mechanisms for promotion of generic drugs through amendments in drug laws. The Draft NPP 2017 also thrusts its weight behind this. All these measures are definitely guided by the right intentions, however, like other recent instances of government doling out abrupt policy decisions without proper planning and preparation and thereby causing some amount of avoidable collateral damage, these measures must also be well thought through and planned and not just be imposed upon without preparation.

The bulk drug industry is a glowing example of how policies can affect a sector as a whole. Now, after a decade, it is optimistic to see that through the Draft NPP 2017 the government is trying to revive India’s bulk drug market which has long gone to China. Whereas, a positive approach is that the suggestion of setting up of mega bulk drug parks. In the draft pharmaceutical policy 2017, one of the yet another approach that seems rather abrupt is the thought of the Draft NPP 2017 to recommend levy of 'peak customs duty' for all bulk drugs that can be indigenously

manufactured.

Government policies have a far reaching effect upon shaping up an industry sector and determining its growth, both in fiscal terms and its capability to move up the value chain. Innovation is one aspect that is critical for the pharma industry to develop its value profile. It is quite established by now that IPRs play a crucial role in providing incentives for innovation. One may find reference of IPR and innovation in every government policy. Yet the letters of policy still needs to be seen implemented in reality through concrete steps on the ground. Be it making the IPR environment more conducive for small and incremental innovation, getting IPR registrations in a faster and transparent manner and ensuring IPR enforcement more expeditious and friendly for the innovators.

It is therefore important to take positive learnings from the experiences of 2017 and design further policy actions in a more inclusive way in the next year so that growth and development is designed for all stakeholders and not designed to benefit one spectrum of the stakeholders at the cost of another.

EXPRESS PHARMA

33

January 1-15, 2018

RESEARCH I N T E R V I E W

KRABEVA will be an important addition to our oncology portfolio of novel biologics as well as biosimilars Biocon has recently launched a biosimilar in the Indian market. Suresh Subramanian, Sr Vice President & Head Branded Formulations, Biocon, gives more details about the product and their plans for it, in an interaction with Express Pharma You have launched a new biosimilar called KRABEVA in India. Tell us more about it.

Biocon’s KRABEVA is a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India.

This is the second key oncologic biosimilar product from Biocon’s global biosimilars portfolio to be launched in India. With KRABEVA, we intend to provide a high quality, worldclass biosimilar Bevacizumab as an affordable therapy option for patients of various types of cancer and help address the unmet patient needs for affordable biological therapies. We believe KRABEVA will be an important addition to our oncology portfolio of novel biologics as well as biosimilars, which are making a significant impact in the realm of cancer care in India.

KRABEVA is being launched in India post successful completion of Phase III clinical trials and approval of Biocon’s Marketing Authorization Application by the Drug Controller General India, DCG(I).

What is the market opportunity for this biosimilar as there are

34 EXPRESS PHARMA January 1-15, 2018

which change colour irreversibly if the cold chain temperature is not maintained. Most biologic products require a specific storage condition to maintain safety, purity and potency of the drug. An efficient and seamless cold chain prevents denaturation of antibodies due to heat. This first-of-its-kind ‘Qual Check’ feature ensures quality check of the product up to the point of administration to the patient.

This will provide greater confidence to pharmacists, nurses and caregivers about the quality of the product they are dispensing and will enable better patient safety.

multiple players already with biosimilar version of Bevacizumab?

The size of the market for Bevacizumab in India is estimated to be ` 177 crores, with a growth of 15 per cent YoY, according to IMS June MAT Data. In fact, the entry of biosimilar versions of Bevacizumab last year have expanded the market for the drug. Bevacizumab sales volume has risen over 1.5 times since 2015, from nearly 50,000 units to over 83,000 in 2017. Interestingly, over 45 per cent of this volume can be attributed to biosimilars.

Within a year, the sales

volume of biosimilar versions has grown almost 16 times.

This indicates the growing acceptance of biosimilar versions of Bevacizumab.

What differentiates KRABEVA from among others brands of biosimilar Bevacizumab?

KRABEVA is the world’s first and only Bevacizumab with a unique ‘Qual-Check’ mechanism, which will ensure that patients get a qualityascertained product right up to infusion. KRABEVA’s innovative temperaturesensitive packaging includes thermo-chromic stickers,

Biocon is known for high quality at an affordable price. What will be the price for KRABEVA? Biocon has priced the product at an MRP of ` 24,000 for 100 mg/4 mL vial and ` 39,990 for 400 mg/16 mL vial. This is substantially lower than the MRP of the 400 mg presentation of the innovator products currently available and lower than some of the other biosimilar versions in the market.

Tell us about the clinical development programme for Bevacizumab.

KRABEVA was launched in India after a successful Phase III clinical trial on metastatic colorectal cancer (mCRC)

patients in India. The study found KRABEVA to be equivalent in terms of safety, efficacy and immunogenicity to the reference biologic. A three-way Phase I PK study in healthy volunteers was also conducted in Europe.

Currently, a global Phase III trial in Non-Small Cell Lung Cancer (NSCLC) patients is being conducted at more than 100 sites across multiple countries.

How much time did it take you to bring bevacizumab to market from the start?

It usually takes six to eight years to develop a biosimilar molecule. Biocon’s biosimilar bevacizumab candidate has been developed with a clear focus to meet strict quality and regulatory requirements and increase patient access in India and globally, including the US and EU. From your experience in various international markets, how much time does it take for a biosimilar approval process in India?

The approval process in India upon submission of the complete data package can take up to six months, approval in certain ROW countries could take up to two years, while in developed markets like the US and EU it ranges between 10-15 months.

EP News Bureau

UPDATES

Roche drug cocktail doubles chance of holding lung cancer at bay 37 per cent of patients in a closely watched clinical trial who received Tecentriq, Avastin and chemotherapy reached the one-year mark without their cancer progressing ADDING ROCHE’S immunotherapy Tecentriq to older drugs doubled the percentage of lung cancer patients who survived a year without their disease advancing, an outcome some experts labelled unprecedented.

37 per cent of patients in a closely watched clinical trial who received Tecentriq, Avastin and chemotherapy reached the one-year mark without their cancer progressing (PFS), according to data released recently. For patients getting only Avastin and chemotherapy, that fell to 18 per cent.

Roche’s announcement in November that its Impower 150 trial had broadly succeeded in first-line lung cancer patients helped spur a one-day, $12 billion rally in the Basel-based drug maker’s market capitalisation.

Severin Schwan, CEO, Roche sees an opportunity to leap-frog ahead as competitors still await their own lung cancer combination trial results.

“This is very, very promising,” Dr Solange Peters, the head of Medical Oncology at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, said on the latest results.

“Doubling PFS (progressionfree survival) at one year is something we have not seen with any targeted therapy in unselected patients to date.”

In a second significant trial result, Roche also released positive interim data from its recently approved haemophilia drug Hemlibra dosed every four weeks, saying the results were consistent with previous studies

annual sales are seen topping $4.6 billion by 2023.

Lung cancer is easily the biggest oncology market, with about 220,000 people in the US due to be diagnosed this year and 155,000 seen dying from the disease often caused by smoking.

In Roche’s 1,202-patient study, patients getting Roche’s immunotherapy survived an average of 8.3 months without their disease getting worse, only modestly better than the PFS of 6.8 months for those getting chemotherapy and Avastin.

Still, analysts focussed more on the 38 per cent reduction in risk of disease progression or death in the Tecentriq group, well within the range they have said would signify a robust result.

For a set of patients who expressed a specific biomarker called 'Teff' that Roche is exof the medicine dosed once a week or every two weeks.

Roche said it would submit the results from both studies to regulatory authorities around the world.

Analysts said the ‘highly significant’ risk reduction from the study will help cement Tecentriq as a strong competitor to Merck’s Keytruda.

Roche is counting on $150,000-per-year Tecentriq to help replace revenue from its $20 billion-per-year trio of Avastin, Herceptin and Rituxan whose patents have expired or will shortly, exposing them to cheaper competition.

According to estimates collected by Reuters, Tecentriq

To subscribe: bpd.subscription@expressindia.com

ploring to help identify people who may respond best, the results were more robust, with a 49 per cent risk reduction and PFS at 11.3 months for the Tecentriq group versus 6.8 months.

Roche, which said serious adverse events were seen in 25.4 per cent of patients getting the Tecentriq combination compared with 19.3 per cent in the Avastin-chemo group, is still awaiting Impower 150’s overall survival data in the first half of 2018.

Still, the trial’s head, Dr Martin Reck of Germany’s Lung Clinic Grosshansdorf, said those numbers 'look encouraging.'

Tecentriq is already approved in bladder cancer treatment and for lung cancer patients who have failed chemotherapy.

Reuters

Novartis combo therapy for melanoma gets FDA priority review The review covers combination therapy for the adjuvant treatment of patients with stage III melanoma THE US Food and Drug Administration has granted priority review for Novartis’s Tafinlar in combination with Mekinist for treating some patients with advanced melanoma, the Swiss drugmaker said. The review covers the combination therapy for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations following

complete resection. In October, the FDA also granted breakthrough therapy designation to Tafinlar in combination with Mekinist for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection, the company said in a statement.

Reuters

EXPRESS PHARMA

35

January 1-15, 2018

RESEARCH

Trial results of Zika vaccine FDA approves Novo Sanofi dropped show promise Nordisk diabetes The ZPIV vaccine, made from inactivated Zika virus particles, was developed by US Army researchers, who in July 2016 had agreed to give Sanofi an exclusive license to complete testing and bring the product to market A ZIKA vaccine Sanofi dropped in September under political pressure over pricing produced strong responses in more than 90 per cent of those taking part in an early-stage clinical trial, US researchers reported recently.

The results, published in the journal Lancet, offer a first glimpse at the vaccine’s performance in people, and suggest it might have had a promising future.

The interim findings do not guarantee the vaccine would work, but the “immune response data in humans are very promising,” said Dr Dan Barouch, a vaccine researcher at Harvard-affiliated Beth Israel Deaconess Medical Center in Boston, where one of three trials of the vaccine are taking place.

In February 2016, the World Health Organization declared the Zika outbreak in Brazil and elsewhere an international public health emergency because of the link between the virus and severe birth defects, touching off a scramble for a vaccine.

WHO has since downgraded the threat, but the mosquitoborne virus remains a public health concern, especially for pregnant women.

The ZPIV vaccine, made from inactivated Zika virus particles, was developed by US Army researchers, who in July 2016 had agreed to give Sanofi an exclusive license to complete testing and bring the product to market.

The deal hit a snag in March when Vermont Senator Bernie Sanders and other lawmakers wrote letters urging Army officials to cut a more favourable deal for the vaccine developed with taxpayer money.

In July, Sanders proposed a rule to end ‘price gouging on tax-

36 EXPRESS PHARMA January 1-15, 2018

payer-funded products’ by requiring federal agencies to secure agreements that such products will be reasonably priced.

Dr Amesh Adalja, a senior associate at the Johns Hopkins Center for Health Security, said accusations like those by Sanders could have a chilling effect on companies’ decisions to partner with US government scientists during epidemics.

“Emerging infectious diseases such as Zika are not the same thing as making a pill for cholesterol. It’s a very limited market,” he said.

In August, the Biomedical Advanced Research and Development Authority (BARDA), the development arm of the Department of Health and Human Services, pulled funding for clinical development of the ZPIV vaccine.

At the time, Sanofi cited BARDA’s decision, along with the difficulty in staging human clinical trials during the waning days of the Zika epidemic, as reasons for its decision to drop development of the vaccine.

Sanofi spokeswoman Ashleigh Koss said developing vaccines for emerging infectious

disease is “a high-risk endeavour.”

“We have been clear about the importance of public-private partnerships in addressing emerging infectious diseases like Zika and believe it is essential for vaccine manufacturers to collaborate with governmental scientific organisations,” she said in an email on Monday.

BARDA is continuing to back several Zika vaccines, including one similar to ZPIV from Takeda Pharmaceutical Co. Takeda last week said it had begun a Phase 1 trial with results expected next year.

“They are essentially the same type of a product,” said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Disease, in a phone interview on Monday.

“The only thing is Takeda owns it so there isn’t the issue of the government giving them an exclusive license.”

Colonel Nelson Michael of the Walter Reed Army Institute of Research said by email on Monday that the Army was exploring licensing the ZPIV vaccine to other companies.

Reuters

drug Ozempic

The company said it plans to price the drug at $676 per prescription,which it described as ‘at parity’to current market-leading drugs in the same class THE US Food and Drug Administration approved Novo Nordisk’s diabetes drug Ozempic, setting the stage for a heated battle with Eli Lilly & Co’s Trulicity.

Ozempic, known generically as semaglutide, will compete with others in a class known as glucagon-like peptide-1 (GLP-1) analogs, which imitate an intestinal hormone that stimulates the production of insulin.

Ozempic is a once-weekly injection that Novo Nordisk

drive the overall growth of the GLP-1 market, which includes Trulicity and AstraZeneca’sonce-weekly Bydureon.

Novo Nordisk is betting that Ozempic’s proven heart benefit and weight-loss advantage over rival products will increase its attractiveness both to physicians and insurers.

Diabetes drug companies are under pressure from insurers to offer attractive prices in return for a formulary position, the list of medicines approved by an insur-

hopes will take market share from Trulicity, which has been cutting into sales of Novo Nordisk’s once-daily Victoza.

Novo Nordisk is also developing an oral form of semaglutide.

The company said it plans to price the drug at $676 per prescription, which it described as ‘at parity’ to current market-leading drugs in the same class.

The approval comes as Novo Nordisk faces pricing competition to its existing diabetes products. The company is banking on Ozempic to help

ance company for reimbursement. Dr Todd Hobbs, Chief Medical Officer, Novo Nordisk, has said the company planned to “take a very competitive strategy with the payors” in order to gain market share. He said the company has strong relationships with prescribers built up over the years with Victoza.

GLP-1 products are also expected to face increased competition from biosimilars, less expensive versions of rival diabetes drugs.

Reuters

RESEARCH

FDAapproves heart protection claims for Amgen cholesterol drug A study released in March of more than 27,500 patients showed that Repatha cut the risk of heart attacks by 27 per cent and stroke by 21 per cent compared with a placebo in high-risk patients already on high doses of cholesterol-lowering statins such as Pfizer's Lipitor AMGEN CAN now promote the ability of its potent but expensive cholesterol drug to reduce the risk of heart attacks and strokes, after US health regulators approved adding those benefits to the medicine’s prescribing label, the company said recently.

Amgen has long seen this development as critical to clearing onerous hurdles to patient access and unlocking the value of the drug, Repatha, which has had anaemic sales since its August 2015 approval despite its billion-dollar potential.

The injected biotech drug was approved on the basis of its ability to dramatically lower bad LDL cholesterol.

But health insurers and

pharmacy benefit managers have made it extremely difficult for patients to get the medicine, even those whose dangerously high cholesterol met criteria for

use in the original label approved by the Food and Drug Administration.

As many as 75 per cent of patients prescribed the medicine

have been denied coverage despite numerous appeals, severely holding back sales.

Repatha sales, while gradually improving, were just $89 million in the third quarter.

A study released in March of more than 27,500 patients showed that Repatha cut the risk of heart attacks by 27 per cent and stroke by 21 per cent compared with a placebo in high-risk patients already on high doses of cholesterol-lowering statins such as Pfizer's Lipitor. In the second year of the study, the benefits were more pronounced, with a combined heart attack and stroke risk reduction of 33 per cent.

But Amgen by law was unable to promote those benefits

until the FDA approved adding those claims. The company has repeatedly said having the heart benefits added to the official label was necessary to get insurers to loosen their purse strings.

“With this approval, it’s now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes,” Tony Hooper, Head of global commercial operations, Amgen said in a statement.

“We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine,” Hooper said.

Reuters

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

Board line: 0120-6651500.

Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com

CHENNAI Kailash Purohit The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9552537922 Fax: 044- 28543035 Email id: kailash.purohit@expressindia.com

BANGALORE Kailash Purohit The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Mobile: +91 9552537922 Fax: 080- 22231925 Email id: kailash.purohit@expressindia.com

HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936, Fax: 040 23418675 Email Id: e.mujahid@expressindia.com

KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com

AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015, Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

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.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

37

January 1-15, 2018

RESEARCH

Cancer drug prompts ‘drastic’HIVdecrease in lung cancer patient Opdivo, or nivolumab is a PD-1 inhibitor, designed to help the body’s own immune system fend off cancer by blocking a protein called PD-1 DOCTORS IN France have found the first evidence that a drug normally used to treat lung, kidney or skin cancer may be able to eradicate HIV-infected cells in people with the AIDS virus.

In a case described as potentially exciting by scientists who also advised caution, doctors said a 51-year old man given nivolumab, sold as Opdivo by Bristol-Myers Squibb, saw a ‘drastic and persistent decrease’ in the reservoirs of cells where HIV normally hides away and evades standard treatments.

The case, at the PitieSalpetriere Hospital AP-HP in Paris, was detailed in a report in the Annals of Oncology journal, where the same doctors also gave a case study of another patient treated with Opdivo who did not show any HIV benefit.

“We must remain careful, especially because this is only one case,” said Jean-Philippe Spano, a professor and head of the medical oncology department at the Paris hospital.

“This is the first case of such a drastic decrease of the HIV reservoir (but) we have...another case where there was no decrease.”

“Increasingly, researchers have been looking into the use of certain drugs that appear to re-activate the latent HIV-infected cells,” Spano said. “This could have the effect of making them visible to the immune system, which could then attack them.”

Opdivo, or nivolumab is a PD-1 inhibitor, designed to help the body’s own immune system fend off cancer by blocking a

38 EXPRESS PHARMA January 1-15, 2018

FDA aims to approve more drugs based on early clinical data Cancer drugs that cause tumours to shrink are considered likely to confer a meaningful clinical benefit, such as survival THE US Food and Drug Administration (US FDA) aims to approve drugs based on very early data if the drug shows a possible benefit in terms of survival, the head of the agency told lawmakers at a hearing.

Speaking before the House Committee on Energy and Commerce, FDA Commissioner Scott Gottlieb said the agency would approve such drugs quickly and figure out

protein called PD-1. It is one of several cancer immunotherapy drugs made by drugmakers including Merck, Roche and AstraZeneca that work in similar way.

In this case, the 51-year-old man had received 31 injections of nivolumab every 14 days since December 2016. He was diagnosed HIV-positive in 1995 and diagnosed with non-small cell lung cancer in May 2015.

After his first injection, the man’s HIV infection load, which had been low, increased progressively up until day 45, then fell back again. At the same time, the doctors explained.

The activity of his immune system increased.

By day 120, the treatment had “resulted in the drastic

decrease in the HIV reservoir leading to a sustained reduction of the HIV reservoirs,” Spano said.

Andrew Freedman, an infectious diseases expert at Britain’s Cardiff University, said the case was 'potentially exciting.' But like others, he advised caution.

“It’s difficult to speculate at this stage why the second patient did not show the same response,” he said in an emailed comment. “Differences in the size of the latent reservoir or genetic differences between individuals, affecting their ability to mount immune responses to HIV, might be important factors.”

Reuters

mined later whether the benefit was statistically significant.

“Even though the observed benefit, in this case, is on a clinical endpoint - an early look at survival - and not a surrogate measure of benefit, we believe using an accelerated approval approach often could be valuable.”

He said the agency was also working on a proposal to more quickly approve cancer

The new proposal would allow approval in a second cancer based on a single arm study in which all patients receive the experimental treatment later whether the benefit seen was real or coincidental.

Gottlieb cited the FDA’s “accelerated approval” pathway as a potential blueprint.

Accelerated approval allows the agency to approve drugs based on substitute measures of clinical benefit.

For example, cancer drugs that cause tumours to shrink are considered likely to confer a meaningful clinical benefit, such as survival.

The same principal could be applied to drugs which appear to increase survival in a small number of people, Gottlieb said. It could be deter-

drugs for additional types of cancer.

Currently, a company with a lung cancer drug would have to conduct randomised clinical trials comparing the drug to a placebo or comparator drug.

The new proposal would allow approval in a second cancer based on a single arm study in which all patients receive the experimental treatment. He said the agency plans to issue guidance clarifying the circumstances in which such an approach would be appropriate.

Reuters

RESEARCH

Men more likely to develop serious heart condition, infective endocarditis,as women: Study The new study allows prevention measures to be targeted at those individuals most at risk of developing IE A TEAM of international researchers, led by the University of Sheffield, have measured the risk of developing or dying from the life-threatening heart condition infective endocarditis (IE), for people with predisposed heart conditions.

The new study, led by Professor Martin Thornhill from the University of Sheffield’s School of Clinical Dentistry, shows that men were more than twice as likely to develop IE as women and that the risk peaked in young children and the elderly.

“Those with artificial or repaired heart valves and certain congenital heart conditions were at much higher risk of developing or dying from IE than the general population,” said Professor Thornhill.

“And the risk of developing IE again was even higher in those who previously had IE. “Surprisingly, the risk of IE was substantially reduced in those with repaired congenital heart defects although those in

whom the repair involved shunts or conduits had a much higher and progressively worsening risk of developing or dying from IE.”

In recent years there has been an increasing number of people in whom implantable pacemakers and defibrillators have been inserted to treat

heart problems and the study showed for the first time that these individuals also have an increased risk of IE. IE is a serious heart infec-

tion that kills around a third of those who develop it within the first year and causes long-term and serious disability in those who survive.

The findings, published in the European Heart Journal, are particularly important because they allow prevention measures to be targeted at those individuals most at risk of developing IE and they allow clinicians and patients to better evaluate the risk of this complication before procedures such as artificial heart valves, implanted pacemakers are performed.

These findings may also help international guideline committees to improve their guidance on the prevention of IE and the risks associated with different cardiac procedures.

This research was funded

by Heart Research-UK and The US National Institutes for Health.

EP News Bureau

FDA OKs Mylan’s biosimilar of Roche cancer drug Herceptin Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision THE US Food and Drug Administration has approved Mylan's biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin, making it the second copycat cancer drug to be approved in the US. The FDA said Mylan's drug Ogivri, which was co-developed with India's Biocon, was the first biosimilar approved in the US to treat breast or stomach cancer.

Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.

Herceptin is one of the world’s most successful antibody drugs and has been a mainstay of Roche profits for many years.

Annual sales of Roche’s cancer medicines exceed $21

To subscribe: bpd.subscription@expressindia.com

billion or over half its pharmaceuticals business sales but the drugs - Rituxan, Herceptin and Avastin - are coming under threat as their biosimilar versions get approval. The FDA in September approved Amgen's biosimilar of Avastin.

The FDA approved Mylan’s Ogivri to treat certain types of breast and stomach cancers.

However, the launch of Ogivri is uncertain at this point, following a licensing

agreement with Roche, Cantor Fitzgerald analyst Louise Chen wrote in a note to clients.

Mylan and Biocon reached a settlement and licensing agreement with Roche in March to launch the biosimilar in major markets. The terms of the deal and launch dates for the biosimilar in different markets were not disclosed, Mylan said.

Barclays analyst Douglas Tsao said although the drug is

not expected to be launched until 2019, the approval adds credibility to Mylan’s biosimilar efforts.

Mylan and Biocon are also developing a biosimilar to Amgen’s drug Neulasta, which got a complete response letter (CRL) from the FDA in October, asking for more data related to their manufacturing facilities.

Reuters

EXPRESS PHARMA

39

January 1-15, 2018

PHARMA ALLY INSIGHT

Technology of liquid filled hard capsules Dr Milind Biyani, Director, Aspire Advisors, highlights on liquid filling process for automatic machines

H

ard capsules enable filling liquid or semisolids into hard capsules using liquid filling capsules machines. Two-piece hard capsules made of either gelatin or HPMC can be used for filling and band sealing non-aqueous liquid, paste, suspension, hot melts, and other vehicles that melt up to 70° C and flow easily (1). Filling of hard capsules is simpler, compact and economical process than soft gelatin capsules (SGC). Hard capsules have thinner walls and need overall four to five times lesser gelatin than SGC. It is not possible to fill hot melts in SGC. These can lose shape in topical and humid climates.

Hard capsules reduce the exposure to oxygen and can be purged with Nitrogen. It also reduces product migration and odor into the shell.

The uniformity of liquid fill is in most cases better than powder filling machine (2). This is useful for low dose/potent drugs. During liquid filling there will be no dust generation which is helpful for formulation with toxic/irritant drugs. Materials which are liquid at room temperature present difficulties when formulating as dry powders, often requiring high concentrations of excipients to avoid processing problems. Fewer excipients are needed for liquid-filled formulations.

Bioavailability of poorly water soluble drug can be significantly increased. Absorica (Isotretinoin capsules) was approved as 505(b)(2) product due to enhanced bioavailability. Hygroscopic drugs can also be handled using gelatin hard capsules (e g Vancomycin capsules) or HPMC

40 EXPRESS PHARMA January 1-15, 2018

hard capsules.

Recently, there has been a revival of interest in the filling of conventional two-piece hard capsules with semisolids. The ability to fill the capsules on semiautomatic or automatic equipment is a recent development (2). Combination filling such as pellets, tablets and another capsule in addition to the liquid is possible with such machines. The Fluidocap 1000 is R&D scale semi-automatic machine that integrates the filling, closing and band sealing processes.

The machine is fitted on a trolly. Output is up to 1000 capsules per hour.

The schematic presentation of the liquid filling process for automatic machines is described in the below figure.

For production scale machines, Fluidocap F20 and F40, output is 20,000 and 40,000 capsules per hour respectively with standard dosing equipment. With seal free

achieved by using multiples of dosing pumps.

The Fluidocap technology is the combination of various mechanisms and these systems include: ◗ No Capsule No Fill (NCNF) ◗ Seal free dosing block (optional) ◗ Purging of filled capsules ◗ Combination filling provisions ◗ Industrial PC interface

dosing the output can go up to 35,000 and 60,000 capsules per hour for F20 and F40 respectively (3). There are minimal problems in the scale up to a production scale because increases in output are

Seal free dosing block advantages as compared to the standard are as follows: ◗ Capable of processing high viscosity liquids ◗ Eliminates cross contamination ◗ Higher accuracy in fill weights ◗ No-drip mechanism at stoppage ◗ Easy to clean, hence maximising uptime ◗ Higher and more assured productivity Interchangeable nozzles of diameter 1, 1.5 and 2 mm are

FIGURE – LIQUID FILLING PROCESS FOR AUTOMATIC MACHINES

offered for filling liquids with different viscosities. Production scale machines are operated with servo motors for accuracy and fitted with ceramic dosing pumps to avoid cross contamination.

Finer dose adjustment is done through HMI in steps of 0.1 mm. The hopper is equipped with variable speed stirrer as well as the maximum and minimum liquid level sensors.

If the viscosity of the liquid is low or if the formulation is mobile at ambient temperatures, the capsules will need to be sealed immediately after filling. One of the reasons that prevented the use of hard capsules for liquid-filling in past, was the propensity for leakage through the gap between the cap and body of the capsule (2).

Proseal (3) is the new improved version of automatic bandsealing machine. In case of HPMC capsules, HPMC band sealing can be done. With speeds up to 70,000 capsules per hour, band sealing by Proseal provides benefits such as effective leakage prevention, FDA compliant tamper proof capsules, anticounterfeiting, and improved shelf-life.

References 1. Milind Biyani, Choosing Capsules: A Primer, Pharmaceutical Technology, 41(10), 3641, 2017.

2. Geoff Rowley, ” Filling of Liquids and Semi-solids into two piece hard capsules”, in Pharmaceutical Capsules, Ed.

by Fridrun Podczeck, Brian E. Jones, Eds (Pharmaceutical Press, 2nd edn.,2004), pp. 169-194.

3. www.acg-pam.com/products/ production-scale/capsulefilling/fluidocap-sealing.php

VENDOR NEWS

Agilent receives multiple innovation awards Ultivo Triple Quad LC/MS with the 1260 Infinity II Prime LC, and Captiva Enhanced Matrix Removal—Lipid make it to the top 15 innovations AGILENT TECHNOLOGIES' Ultivo Triple Quadrupole LC/MS system together with the Agilent 1260 Infinity II Prime LC and Agilent Captiva Enhanced Matrix Removal— Lipid technology have made it to The Analytical Scientist's list of this year's top 15 innovations. The awards highlight innovations delivered by transformative technology. The winners were chosen by a panel of experts, including members of the magazine's editorial advisory board and editorial staff.

“Now in year five, the Innovation Awards continue to shine a light on the instruments and technologies that are having a big impact across the analytical sciences,” said Charlotte Barker, the editor of the magazine. “We had a record number of entries this year, and the final 15 reflect the full spectrum of analytical advances.”

“At Agilent, we continually strive to help laboratory scientists be more successful by delivering innovation that matters in the form of leadingedge products across a variety of uses,” said Monty Benefiel, Agilent vice president and general manager of Agilent´s Mass Spectrometry Division.

The Agilent Ultivo Triple Quadrupole LC/MS marks the next generation of LC/TQ instruments. It offers performance equivalent to or better than larger LC/TQ systems, with the added benefits of being smaller, easier to use and costing less to operate. Laboratories benefit from its space-saving and stackable design, providing optimal use of lab bench space, plus early maintenance feedback, enhanced serviceability, intuitive operational design, and robust/reliable performance

The winners were chosen by a panel of experts, including members of the magazine’s editorial advisory board and editorial staff

in difficult matrices. The 1260 Infinity II Prime LC completes the system, offering the highest sample capacity per bench space for any laboratory. Agilent's Captiva EMR— Lipid pass-through SPE format simplifies workflows and reduces sample preparation steps. With cleaner samples (removing >99 per cent of phospholipids), the method sensitivity and analyte recovery is improved, which results in faster data analysis, better reproducibility and higher data confidence. By avoiding the introduction of a heavyladen matrix into the system, unscheduled downtime is reduced.

EP News Bureau

CAPTIVA VS PPT COMPARISON

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

41

January 1-15, 2018

PHARMA ALLY PRODUCT

Clean room high speed doors,a necessity BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which one can limit the amount of dust and dirt in the area of the manufacturing.

Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process.

Clean rooms have become an integral part of pharma manufacturing facilities.

One of the most important aspects of cleanrooms is the doors one chooses for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to be quick enough to isolate the outside environment and internal facility.

Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities where there is a requirement for 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 feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction

42 EXPRESS PHARMA January 1-15, 2018

◗ 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 Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email : sales@geapl.co.in Website: www.geapl.co.in

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

January 1-15, 2018

43

BUSINESS AVENUES

44

January 1-15, 2018

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

January 1-15, 2018

45

BUSINESS AVENUES

Wiper Type Sight Glass

EXPRESS PHARMA

DIN 100 Light Glass LED

Swastik Associates

OSMOMETER 3250

Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com

Our other product details u

SS Fittings

u

SS Valves Manual & Pneumatic

u

SS Filters

u

SS Pumps: Centrifugal, Self Priming & Shear Pump

u

SS Powder Blender

u

SS Steam & Water Mixing Station

u

Drain Trap

Manhole Round Dia 450

Sight Glass Flange with LED

LED Bush

4W / 15W / 20W / 24W

Manhole Pressure Type

Manhole Elliptical

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

LABORATORY EQUIPMENTS

Lab Stirrers Hot Plate Magnetic Stirrers

Walk-in chamber

Refrigerated Centrifuge Deep freezer

Single Door Refrigerator

Laboratory Centrifuge

Cyclomixer

Mini Rotary Shakers

Incubator Shaker

REMI SALES & ENGINEERING LTD. Remi House, 3rd Floor, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai - 400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com l Website: ww.remilabword.com

46

January 1-15, 2018

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

January 1-15, 2018

47

BUSINESS AVENUES

EXPRESS PHARMA

To Advertise in

Business Avenues Please Contact: ■

Mumbai: Rajesh Bhatkal

■

09821313017 ■

Kailash Purohit

Ahmedabad: Nirav Mistry 09586424033 ■

Chennai ■ Bangalore:

+91 9552537922 ■

Hyderabad: Mujahid

Delhi: Ambuj Kumar 09999070900

09849039936 ■

Kolkata: Ajanta 09831182580

48

January 1-15, 2018

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

www.kesarcontrol.com

www.kesarcontrol.com

www.kesarcontrol.com

Humidity Chamber

Cold Chamber

Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727

Mobile : 09427613646 Email : service@kesarcontrol.com

EXPRESS PHARMA

January 1-15, 2018

49

BUSINESS AVENUES

50

January 1-15, 2018

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

January 1-15, 2018

51

PHARMA LIFE I N T E R V I E W

I need to sort out challenges which have emerged due to govt policies Jagannath Shinde, President, Maharashtra State Chemists & Druggists Association, in an interaction with Usha Sharma, talks about his re-election and why online pharmacies should not be promoted by the government You have been re-elected for the fourth time. What added responsibilities will you have?

I have witnessed elections in AIOCD across various posts since the last 25 years. Since the last 12 years, I am shouldering the responsibilities of the chemists fraternity of India. As the President of AIOCD, my role will be to work more vigorously. In my current tenure, I need to sort out many new challenges which have emerged due to new government policies in the health sector.

Which are the issues faced by pharmacists and what are the solutions provided by AIOCD? There were several issues like hike in heavy license fee, renewal fee, new drug policy and DPCO and its impractical implications, GST return on leakage, breakage expiry of goods returned to manufacturers, and most importantly, internet/online pharmacy. We have raised our concerns with the government regarding increased license fee and it has been sorted out successfully. We have a series of representations on new drug policy and online pharmacy with the government, which they are proactively looking into.

What steps have the AIOCD taken to uplift the morale of pharmacists across India?

We are all aware about that the

52

EXPRESS PHARMA

January 1-15, 2018

We have a series of representations on new drug policy and online pharmacy with the government, which they are pro actively looking into changing scenario. I believe our chemists should gear up and be ready to compete with incoming retail chains.

Looking at this scenario, I have started a programme for retailers in Maharashtra with the help of State Pharmacy

Council to update/upgrade the knowledge of pharmacists by conducting Continuing Education Programmes (CEP) and Patient Council Programmes (PCC) in every district and taluka. The programme will enhance chemists about the latest knowledge, practical approach towards needy patients, fully computerisation of retail shops and patient counselling. These are the main subjects taught in the programme.

Almost 60 per cent of registered pharmacists have taken part in the initiative and have updated to compete with the retail chains. I plan to spread the programme across India.

As the President of AIOCD and Maharashtra Safe Chemists and Distributors Alliance (MSCDA), I have launched a limited company under the name and style, AIOCD Limited and MSCDA Limited, through which we are organising such programmes and floated a chain of retailers under the banner M+M (Medicines plus More) to compete with incoming retail chains.

During your tenure in AIOCD, how has the Indian pharma industry evolved?

What has been AIOCD role towards the industryâ&#x20AC;&#x2122;s progress?

We as an association meet the industry on a regular basis and exchange dialogues with them as well as jointly with the

government to resolve issues faced by us. We are of the opinion that we shall grow only when the industry grows and therefore we are always supportive to the pharma industry. Selling/storing of medicines are bound by Drugs and Cosmetics Act and Rules and Drugs Price Control order, which needs to be strictly followed and this we bring to the knowledge of marketing people of the industry to resolve some of the issues. We have cooperated with the government by withdrawing the banned drugs from the market, which has helped the government, industry and administration.

What steps have AIOCD taken to ensure delivery of quality products to the end consumer?

Few drugs require cold storage supply chain which are required for specific diseases.

Some retailers do have supply chain by which such drugs are supplied in metro cities as well as district places. AIOCD has instructed district associations to make such supply chain in their district with few wholesaler and retailers. Hereby, a company as well as chemist maintain the potency of such drugs till the drug reaches the end user that is patient. In some cases, even companies supply such drugs to the end user directly where the chemist are not able to provide cold storage facility.

Continued on Page 53

Out-of the box thinking is the word for success Mayank Chandra, Managing Partner, Antal International, gives an insight about the future recruiting trends in pharma sector THE PHARMACEUTICAL industry has been going through a series of troughs and peaks in the recent few years.

Regulations like the Uniform Code of Marketing Practices (UCPMP) and price caps put

by NPPA continue to pose a challenge to the industry.

At the same time, the year 2018 promises to be one where much will be consolidated. For instance, the CRO industry is slowly picking up due to better regulatory environment, streamlined approval process and slowly more clinical trials are also coming to India.

Equally, in the months to come, while generic drugs may face tough competition, the biosimi-

lar portfolio will grow. Also, companies will drive growth on therapy areas like cardio-diabetic and Onco.

In fact, there is more to anticipate on the pharma front.

Companies are taking several strategic initiatives with the incoming of recent changes in regulations governing the pharma and medical devices industries, primarily to cope up with the loss of business revenue as in the case of recent caps in prices of stents and knee implants. The price caps are being seen to discourage manufacturers, mostly MNCs, from launching their premium products in India. Precisely the time has come for Indian manu-

facturers to come into their own. As of now, names like Sahajanand Medical Technologies, Meril Life Sciences and

Continued from Page 52

arguing that offline pharmacists are not securing medical prescriptions from patients/ relatives and failing the guidelines. What is your say?

Please note that online pharmacy is not permitted in many developed countries for many reasons. Where permission is given for online, strict norms, legal punishment are followed, which is definitely not possible as of today with the present Drugs and Cosmetics Act, 1940, and due to lack of sufficient man power in administration. Any banned drugs, prescription drugs, habit forming hallucinating drugs, abortion pills are freely available through online pharmacy. This has been proved by submitting the authentic documents in Bombay High court in one of the PILs admitted by one lady professor. The high court slammed the government and FDA administration to immediately stop such sale and report to the court within four weeks. I am doubtful

about the action by the government and administration, which is not seen even today.

There is no demand for online medicines except in metro cities. Medicines cannot be bought online like any other products. It needs prescription of an authentic medical doctor, its history, dispensing under the direct supervision of a registered pharmacist and the patient instructions, patient counselling which one should not forget. When government allows or overlooks the allopathy prescription written by a homeopathy doctors, which is not truly permitted by law why not a registered pharmacist can dispense over the counter drugs to needy person when he cannot afford to go to doctor or the MBBS doctors are not available in the area. This is the system followed in other developed countries. One should not forget, sale of medicine is not a business, it is a controlled profession done under educated persons in the

Hence, no patient is deprived of availability of drugs in required temperature.

What will be your say on GST? AIOCD is the first trade association which supported the governmentâ&#x20AC;&#x2122;s GST initiative. It didn't affect the trade in any way except the leakage breakage expiry, saleable goods return to the manufacturers and its repayment to traders in reverse mechanism in GST. This has been addressed to the manufacturerâ&#x20AC;&#x2122;s association as well as GST Council members and the central government. The GST Council members and the finance department has welcomed our memorandum on this issue by understanding it and given instruction to resolve this burning issue at the earliest which we are surely hopeful.

Online pharmacist association have been

To subscribe: bpd.subscription@expressindia.com

Sutures are expanding. Even though the skillset required to manufacture a technologically advanced product like stent remains a challenge, it is foreseen that the companies will put in steps to improve the quality of stents manufactured by local companies and even encourage them to develop more technologically advanced stents, which in turn will help the industry grow in the country.

The impact on recruitment Manpower recruitment and retention gains a whole new meaning given the current scenario. As far as recruitment needs of the organisations are

profession who are registered under different rules and regulation.

During the last one to two yearsyears, there has been a surge in strike by nationwide chemists against online pharmacies. Is strike justified?

Apart from our chain of eight lakh chemists, another 20 lakh people and their families are dependant on this profession.

The government should safeguard us as large number of people will be drastically affected. We have no alternative but to go for a strike to bring our plight to the notice of the government.

What will be your message for the pharma industry and chemists?

The governmentâ&#x20AC;&#x2122;s Jan Aushadhi scheme is not successful due to lack of knowledge of this profession and the working pattern of making drugs available in the pharmacy. We have a chain of eight lakh chemists and it can be successfully implemented

concerned, candidates with technical skills including in regulatory, clinical research, data analyst, R&D roles, will be in much greater demand since traditional sales and marketing processes are getting obsolete.

For candidates in the fray, strategic and out-of the box thinking is the word for success and also stability along with communication skills due to coordination with multiple stake holders across geographies.

Job hoppers are a strict no-no and interestingly, a recent trend in the healthcare sector in regulatory affairs domain is that the senior vintage RAQA professionals are slowly moving into consulting professions.

through our members. I assure you that it would be the biggest success which the whole world will appreciate and follow.

In the last decade which disease profiles have seen a surge?

In the last decade, hypertension, diabetes and psychotherapy are the main/major diseases which have been spread largely in Indian community due to stress factor, consumption of junk food by younger generation. We are giving stress upon the counselling (patient instructions) to such patients in detail on these diseases in our PCC and CEP programmes. To our satisfaction patients are also taking information, knowledge and support of pharmacists to understand how, how much and when to take medicines and precautions while taking them. We are successful for serving the people of India in health care by our knowledge. u.sharma@expressindia.com

EXPRESS PHARMA

53

January 1-15, 2018

PHARMA LIFE

Employee retention and employer branding The pharma industry is finding it difficult to source and retain its existing talent pool.

Thammaiah BN, MD, Kelly Services India, gives an insight on how to solve talent crunch in the pharma industry THE PHARMACEUTICAL industry is also referred to as recession-proof industry. In talent terms, this should bode well for both employees and employers.

Paradox is that the industry is finding it difficult to source and retain its existing talent pool.

Hiring and retention of highly skilled employees is important for pharma sector as employees are the heart and soul of this industry. So, what can pharma companies do, to emerge from this quagmire?

Luckily though, employee retention and employer branding can be achieved through easy and simple steps. Here is a fivepoint guide for pharma companies to follow to solve their talent challenges:

Expand workforce mix Employers should hire a mix of permanent and temporary workers besides retirees, alumni, freelancers and consultants such as entrepreneurs and specialists. Such employees bring new skills and perspectives which could lead to improved efficiencies and help in creation of new ideas. Permanent employees may not have all the specialised skills needed for specific projects causing skill gaps, which can be filled in by highly skilled, experienced pro-

54 EXPRESS PHARMA January 1-15, 2018

candidates a polite mail for being part of interview and inform them that they would be called if there is a relevant opening in the future.

Work on employer branding â&#x20AC;&#x201C; celebrate the employees

fessionals with expertise in their industries hired on project or short-term basis. The benefits of such a workforce mix are lower costs, better efficiency, productivity and speed to market.

Improve candidate experience Generally, Candidate Experience (CX) is not a priority for hiring managers. They tend to overlook the fact that a positive CX will help attract new talent and result in favourable reputation via candidateâ&#x20AC;&#x2122;s word-of-mouth.

Even if a potential candidate does not get selected, organisa-

tions should make sure the candidate had a fair and pleasant experience. For a candidate to have good interview experience, some of the processes could be outsourced to the experts. Automating hiring processes is the best solution to enhance CX, which will allow candidates to advance themselves through the different steps and activities.

Employers should ask employees to fill-in the survey form for their opinion of hiring processes such as what the organisation did well and seek suggestions for improvement. Organisations should also send the rejected

Employer branding is important to attract skilled talent. Posting employee testimonials, videos of team building exercises, CSR initiatives and showcasing staff accomplishments tells a lot about the organisation and shows that the organisation values its employees. Employees should be encouraged to run an employee engagement forum organising cultural and sports events for employees. Employers should take employees feedback seriously and try to improve the culture of organisation.

Create industry-ready talent Innovative talent development programmes, guest lectures along with competency and skill development workshops, are important to make students industry-ready and to increase their chances of getting employed.

Pharma companies should tieup with universities and colleges to provide quality education and share key industry know-how

basis real life and use-case scenarios. Industry experts should design the syllabus as per the industry standards so that transition from college to corporate is smooth. Universities should encourage internships as this is one of the methods that helps interns to get absorbed by the company. Pharma companies can also consider internships for faculty which help train the trainers. This will also help those companies that are unable to mentor or provide training to student interns due to paucity of resources.

Foster innovation Employers should recognise the unique qualities of their employees and value them. They should encourage and give freedom to experiment as great ideas could come from any employee. They should proactively recruit entrepreneurially inclined individuals.

The freedom to experiment should not only be given to R&D department but should be spread throughout the organisation. Employers should provide emerging entrepreneurs training and professional development opportunities in key areas.

The innovative ideas and entrepreneurial behaviour should be financed by organisations which will boost morale of employees.

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001