Express Pharma (Vol.11, No.19) August 1-15, 2016

VOL. 11 NO. 19 PAGES 74

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Market Strict prosecution law will fix drug regulatory system

Research Zika vaccine: A distant dream?

1-15 AUGUST 2016,` 40

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CONTENTS MARKET 2017 US DSCSA

Vol.11 No.19 AUGUST 1-15, 2016

2019 EU DELEGATED ACT

Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

Pharma companies across the world are racing against time to meet the November 2017 deadline of the US DSCSAfollowed by the February 2019 deadline of the EU Delegated Act.Are Indian companies ready for the complexities of serialisation? | 30

Bengaluru Neelam M Kachhap New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar Arun J Debnarayan Dutta E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager B R Tipnis

P12: INTERVIEW Strict prosecution law will fix the drug regulatory system Bejon Kumar Misra, Founder Director, Patient Safety and Access Initiative of India Foundation (PSAIIF)

P14: INTERVIEW ‘Exim Bank will support Indian companies to develop strategic partnership under its OIF Programme’

16

INTRODUCING HEALTHCARE SENATE 2016

17

THE 4TH EDITION OF PHARMATECH EXPO 2016 TO BE HELD IN AHMEDABAD

MANAGEMENT

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CHALLENGES OF GLOBAL TRACK AND TRACE: HOLISTIC APPROACH, COMMON SOLUTION

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RECIPHARM ANNOUNCES GLOBAL SERIALISATION COLLABORATION

RESEARCH

Yeduvendra Mathur, MD, Exim Bank

P32: INSIGHT Serialisation world – A global regulatory canvas

P46: VENDOR NEWS

40

ZIKA VACCINE: A DISTANT DREAM?

AVT names Matt Bennett President of the Americas

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P48: APPOINTMENT Madan Mohan Reddy appointed as Chairman of Pharmexcil India

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Turning threat into opportunity

I

t is human nature to perceive change as a threat. But turning this threat into an opportunity is a crucial skill. Take for example, Brexit. After the initial knee jerk reaction, which included plunging share prices of corporations seen to have a large UK presence, countries and companies seemed to be adjusting their sails. Read our cover story ‘Brace for Brexit', in the August 1-15, 2016 issue for a detailed analysis of Brexit on Indian pharma companies and how some are now waiting to seize the advantage. Isn’t it ironical that as we celebrate our 70th Independence Day, we have a cover story on UK's independence from the EU! The war against counterfeit medicine is another example of how a threat (capital intensive anti counterfeiting measures) will eventually become an opportunity to create a sharper business edge for early adopters. In the past few years, more than 20 countries, including India, have rolled out serialisation/track and trace mandates. Measuring upto these mandates could change the pecking order in the pharma industry, which is why the current Express Pharma August 115, 2016 issue has a section on serialisation.

In ‘Race against time’, Kjell Johansson, President, Manufacturing Services - Europe, Recipharm, a global CDMO, cautions that in general, pharma companies need to place serialisation higher up on their agenda in order to meet the US and EU deadlines. The deadlines may seem far away (November 2017 for the next phase of the US Drug Supply Chain Security Act (DSCSA)) Implementation Plan and February 2019 for the EU Delegated Act, to name just two mandates) but considering the complexity of multiple regulations from different countries,

Measuring upto multiple serialisation mandates could change the pecking order in the pharma industry

smaller CDMOs might be forced to prioritise markets and might lose out.

As a specialist in computerised system validation and serialisation project management, Arjun Guha Thakurta, Director-Operations, Life Science Consulting highlights the compliance deadlines looming ahead and more importantly the project bottlenecks in his article, ‘Serialisation World – A global regulatory canvas’. He estimates that there are less than 20 track and trace vendors and thus the rush to book their services and personnel could see the laggards struggle to start/progress their serialisation projects.

Shaunak J Dave, Asian Market Director, Optel Vision, one of these vendors, applauds the sea change in the awareness and commitment levels in Indian pharma companies over the past six years.

But in his article, 'Challenges of global track and trace: Holistic approach, common solution', he also cautions that the lack of time calls for immediate action. Most global serialisation vendors have created customised solutions by tweaking products and services. For example, Antares Vision, another such vendor, is currently launching a pilot project in India for a top-ten global pharma, which is a leaner, more costeffective serialisation solution for the Asian subcontinent that performs on par with European standards and mandates. Express Pharma will feature case studies on such projects in forthcoming issues because we’re confident India Pharma Inc will rise to this challenges as well.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

Strict prosecution law will fix the drug regulatory system Bejon Kumar Misra, Founder Director, Patient Safety and Access Initiative of India Foundation (PSAIIF) in a tete-e-tete with Prathiba Raju, says that the government should bring in new, updated, patient centric Drugs Control Act without any delay

India is the third largest drug producer in volume and 12th largest in value globally, yet we lack a pharmacovigilance system in our country. What are the reasons behind this?

We have a Pharmacovigilance Programme of India (PvPI), which is yet to be fully utilised as either patients nor medical practitioners are aware about its existence. Many in India are not aware about the toll free helpline telephone number of PvPI, which is 1800-180-3024.

You should call at this number and report any kind of adverse drug reactions (ADRs) when you feel that medicines administered didn't provide the expected outcomes. Every medical practitioner should use this number. We must also encourage patients to use the toll free number.

Is the Drug Controller General (India) (DCGI) struggling to ensure the quality of drugs in the market?

DCG(I) is definitely struggling as it lacks infrastructure and the desired cooperation from state drug controllers. We have extremely poor reporting systems on drug testing and its outcomes. Though there is data, we don’t know how credible it is and whether they have been conducted in a statistically scientific manner.

We must introduce third party audits and encourage patient organisations to get engaged with the state drug controllers.

We are trying our best to

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August 1-15, 2016

improve the system based on the Mashalkar Committee Report and other Parliamentary Committee reports.

What steps should the government take to upgrade the regulatory set-up?

The government should have a modern, updated and stringent law in place of the existing Drugs and Cosmetics Act 1940.

The British Raj has left but we are still continuing with the Inspector Raj. We should now move forward and make patient safety and accessibility to quality healthcare as the main pillars to the proposed law and ensure proper coordination between the Central and the state governments. We should have established testing facilities with National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation in every district of the country and make the process transparent and accountable to the patients.

Good manufacturing and distribution practices, equivalent to if not more than the global best standards should be followed.

How has online pharmacies transformed the average Indian healthcare consumer?

Online pharmacies have brought choice to patients and dismantled the cartels which existed in our country in the garb of associations of chemists and druggists. Now, we have a

fair competition and the manufacturers of medicines in our country can have options to sell their products to the consumers at a competitive price. The only challenge is that online pharmacies are not regulated in the manner desired and states doesn't allow them to function for the interest of the consumers. The Sub Committee constituted for the purpose of recommending the governments on how to regulate online pharmacies, is a right step and hopefully by the end of this month, the committee will be able to submit its recommendations.

Proper documentation of medicines are necessary so that they are not prescribed irrationally and the government should introduce a robust track and trace mechanism

What would be a clear-cut operating model for online pharmacies which is in line with the concerns of the chemists, while providing benefits to customers?

A level playing field between online pharmacies and regular physical stores to ensure safety and quality to the consumers is a must. Moreover, proper documentation of medicines are necessary so that they are not prescribed irrationally and the government should introduce a robust track and trace mechanism.

The European Union has issued a common logo for legally operating online pharmacies/retailers in its member states as one of the measures to fight against certain illegal pharmacies.

Will similar measure work in India?

Of course it is viable in India.

We have also proposed a similar accreditation system like the EU, the US and the UK. In fact, India is known globally for its expertise in IT and it is high time that we create a repository of information on the brands, volume produced and how much has been sold.

What changes would you like to see in the next five or ten years in the pharma sector?

We need institutionalised testing facilities in all districts of our country and prompt action needs to be taken to recall medicines which are found to be spurious or Not of Standard Quality (NSQ). A modern law, which punishes the culprits who play with the health and safety of the patients and a strong pharmacovigilance programme in India with a efficient tracing and tracking mechanism is a must. Slowly reducing the number of brands made available in India and we should focus on making generic names mandatory for medical practitioners to write along with the equivalent name of the branded medicines. Bringing fair competition and a strong regulatory mechanism will ensure all essential medicines are made accessible in adequate quantity and not bring price control as it breeds unfair business practices and denies the patients from accessing quality and safe medicines. prathiba.raju@expressindia.com

MARKET I N T E R V I E W

‘Exim Bank will support Indian companies to develop strategic partnership under its OIF Programme’ Export-Import Bank of India (EXIM Bank) has, at the behest of the Government of India, extended a Line of Credit (LOC) of $20 million to the Government of the Republic of Côte d’Ivoire, for financing Mahatma Gandhi IT and Biotechnology Park. Yeduvendra Mathur, CMD, Exim Bank, reveals more to Usha Sharma about the investments

What was the reason behind Exim Bank extending a LOC to Government of the Republic of Côte d’Ivoire?

Exim Bank extends LOCs on its own, and also at the behest and with the support of Government of India (GoI) under the Indian Development and Economic Assistance Scheme (IDEAS) with an objective to share India’s development experience through: a) capacity building and skills transfer; b) trade; and c) infrastructure development towards socioeconomic benefits in developing partner countries.

India is working closely with the Government of the Republic of Côte d’Ivoire to make Mahatma Gandhi IT and Biotechnology Park (MGIB) a success. Early in the project, Côte d’Ivoire benefited from Indian expertise to create this free zone dedicated to Information and Communication Technology (ICT) and biotechnology. The park is located in the town of GrandBassam, a historic seaside town, on the outskirts of the commercial capital of Abidjan.

Government of India (GoI) is also assisting in capacity building in the IT sector by offering scholarships under its Indian Technical and Economic Cooperation (ITEC) Programme.

At the behest of GoI, Exim Bank extended LOC of $25.50

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August 1-15, 2016

million to the Government of Côte d’Ivoire for financing (i) Mahatma Gandhi IT and Biotechnology Park (MGIB), (ii) Fisheries Processing Plant and (iii) Coconut fibre processing plant. Out of $25.50 million, $20.00 million has been allocated for financing MGIB Project in Côte d’Ivoire under the TEAM-9 initiative of GoI. A LOC is a financing mechanism through which Exim Bank extends support for export of projects, equipment, goods and services from India. Under $20.00 million, two contracts were awarded to Indian companies viz. Shapoorji Paloonji and United Telecoms India.

Construction of the Free Trade Zone (FTZ) by SPCL: Scope of work consists of architectural concept and standards for the buildings in the park, design, architectural and technical study, construction of the building hosting IT enterprises, and construction of 2.7 km compound wall around the Village of Information Technology and Biotechnology (VITIB)’s campus.

Supplies by UTIL: Supply and installation of computer assembly plant, DNA lab, satellite earth station, audiovideo studio, and telecom lab, generator, and data storage network.

How will it accelerate the growth of Indian biotech and IT companies and what

benefit will Indian companies have?

MGIB was born with the desire of Côte d’Ivoire to create a free zone dedicated to ICT and Biotechnology.

Côte d’Ivoire government aspires to build MGIB as one of the most modern IT Park in West Africa. It will be the technological showcase of West Africa. Being a member of Economic Community of West African States (ECOWAS), Indian companies setting up in the park will have access of ECOWAS market. ECOWAS is a 15member regional group with a mandate to promote economic integration in all fields of activity of the constituting countries (Benin, Burkina Faso, Cape Verde, Côte d’ Ivoire, The Gambia, Ghana, Guinea, Guinea Bissau, Liberia, Mali, Niger, Nigeria, Sierra Leone, Senegal and Togo).

The Common External Tariff is one of the instruments of harmonising ECOWAS Member States and

strengthening its common market. ECOWAS Treaty defines the aims of the community as promoting “cooperation and integration, leading to the establishment of an economic union in West Africa. Indian companies are encouraged to form joint ventures (JVs) with Ivorian companies. Exim Bank will support Indian companies to develop strategic partnership under its Overseas Investment Finance (OIF) Programme.

(i) Capital expenditure towards acquisition of assets; (ii) Working capital; (iii) Equity investment in another company; (iv) Acquisition of brands/ patents/ rights/ other IPR; (v) Acquisition of another company; (vi) Any other activity that would otherwise be eligible for finance from Exim Bank had it been an Indian entity. d) Guarantee facility to the overseas JV/ WOS for raising term loan/ working capital.

Tell us more about the bank’s overseas investment finance programme. Will it help Indian and West African companies to forge a strategic partnership?

Exim Bank encourages Indian companies to invest abroad for setting up of manufacturing units and for acquiring overseas companies to get access to the foreign market, technology, raw material, brand, IPR etc. For financing such overseas investments, Exim Bank provides: a) Term loans to Indian companies of upto 80 per cent of their equity investment in overseas joint venture (JV)/ wholly-owned subsidiary (WOS). b) Term loans to Indian companies towards upto 80 per cent of loan extended by them to the overseas JV/ WOS. c) Term loans to overseas JV/ WOS towards part financing

How many Indian biotech and pharma companies have their presence at MGIB Project in Côte d’Ivoire?

What regulatory requirements are required to set up a plant at the park?

As on date, two pharma companies (Pharmanova Ghana, Subsidiary of Pharmanova, Ghana; and Strides Pharma, subsidiary of New Life Pharmaceutical), are in the process of setting up their formulation plant in the park. VITIB is responsible for management, operations and promotion of the FTZ. VITIB was founded by Ivorian and international partners.

VITIB is developing, operating, managing and promoting the FTZ. VITIB will also provide professional and support services for companies in the FTZ. For registration in Côte d’Ivoire, Centre of Promotion of Investments in Côte d’Ivoire (CEPICI) provides ‘one-stopshop’ mechanism and legal

MARKET

framework to maximise administrative efficiency (license, Visa, work permit, import, export).

Long-term visa and work permit for foreign workers and their families are available for companies setting their shops in MGIB. There is no limitation on local and foreign investments. Indian companies are required to adhere to the guidelines pertaining to overseas direct investment, notified by the Reserve Bank of India vide Notification No. FEMA 120/RB-2004 dated July 7, 2004, as amended from time to time.

By when will MGIB Project likely to be completed? Is it going to be a FTZ for IT and biotech. What subsidies will biotech companies get?

Currently in the second phase, 180 hectares are being developed. In the first phase of 60 hectares, VITIB Academy complex is situated comprising VITIB’s office and building for data storage, biotechnology lab, etc. The first phase was formally inaugurated during the visit of Praneet Kaur, Minister of State for External Affairs, the Government of India on January 24, 2014. The project, when completed, will be a dedicated FTZ for IT and Biotechnology.

Companies who want to set up shop at the proposed FTZ can avail the following provisions: a) Zero per cent of customs duties on import and export; b) Zero per cent income tax for the first five years of operations (for tenants and developers of the park); c) One per cent income tax on turnover starting year six with the possibility of tax reduction up to 50 per cent; d) Zero per cent of VAT on electricity, water and oil products consumption; e) Freedom for the transfer of funds generated by salaries and dividends.

the first financial centre of West Africa with a regional stock exchange and second largest seaport in Africa.

What business opportunities are available at Côte d’Ivoire?

Côte d’Ivoire’s economic performance has been impressive over the past four

years with a robust GDP growth. Posting an economic growth rate of almost nine per cent in 2015, Cote d'Ivoire’s growth rate is among the highest in Africa. Economic activity maintained its dynamic pace across all sectors benefiting from a robust aggregate demand and

August 1-15, 2016

u.sharma@expressindia.com

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sector, and $31.2 billion for the private sector. Côte d’Ivoire is regarded a prime destination for investment in Africa, and key sectors for investments are agriculture, agribusiness, mining, hydrocarbon, and industrial sector.

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Côte d’Ivoire is a leader of the economic and monetary union of West Africa, and is

EXPRESS PHARMA

a surge in both private and public investments.

According to Côte d’Ivoire Government’s National Development Plan (NDP) for 2016-2020, Côte d’Ivoire offers investment opportunities amounting to $50 billion, which consists of $18.8 billion for the public

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MARKET PRE EVENTS

Introducing Healthcare Senate 2016 The national private healthcare business summit will be held at HICC, Hyderabad from September 22-24, 2016 REFORMATION has long been a characteristic of human development.

In India, the healthcare development story is similar to the rest of the world. Regardless of all the challenges, healthcare as a discipline continues to evolve. More rightly, it continues to reform.

Express Healthcare, a leading magazine of the Indian Express Group, chronicling all the major events in the healthcare industry in India has been a witness to the reformation that healthcare in India has been undergoing in the last 16 years. Taking it a step further, now we intend to be a part of this reformation through Healthcare Senate, a leadership platform for knowledge exchange.

Healthcare Senate, the national private healthcare business summit, will be held at HICC, Hyderabad from September 22-24, 2016. It would host the game changers, path finders and and opinion leaders of the healthcare industry, to facilitate sharing of innovative ideas and experiences, and convert them into reality.

Most influential healthcare practitioners; CEO/CFO/MDs of hospital chains, medical superintendents, hospital owners and decision makers, owners of single speciality hospitals, owners of diagnostic and other healthcare centres, hospital administrators, HoD of medical and bio-medical departments, HoD of engineering and operations, medical directors, purchase managers, healthcare consultants, project heads, bio-medical engineers, dealers and distributors, thought leaders, industry stalwarts and domain experts would be part of this event.

The three-day event will encompass expert speakers, panel discussions, case studies and power discussions, a technology

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August 1-15, 2016

the Healthcare Sector ◗ Investing in Quality: Best Practices, Accreditation, Infection control, procurement ◗ Patient-driven Innovation in business models To be held concurrently with Healthcare Senate on September 23, 2016, Express Healthcare Excellence Awards will celebrate the spirit of excellence and leadership in healthcare delivery in the private sector. The awards will recognise private hospitals

CONFIRMED SPEAKERS 1. Speaker from Apollo Group of Hospitals 2. Dr AVelumani, Founder,Thyrocare 3.Ameera Shah, MD, Metropolis Healthcare 4. Dr KK Kalra, CEO, NABH 5. CK Mishra,Addl Secretary, MoH&FW

CONFIRMED PANELISTS: DEALING WITH COST BURDEN OF MEDICO LEGAL TANGLES 1. Bejon Misra, Founder Director, Patient Safety and Access Initiative of India Foundation 2. Sanjay Prasad, President & CEO at Mission of Mercy Hospital & Research Centre, Kolkata 3. Mahendra Bajpai,Advocate, Supreme Court of India 4. Manpreet Singh Sohal, CEO, Global Hospitals-Mumbai

500+ hosted buyers

5000 100+ 18 meetings

5. Dr Vivek Jawali, Director - Fortis, Bangalore 6. Dr Sugandhi Iyer, Deputy Director - Legal & Medical , P D Hinduja Hospital 7. Dr Alexander Thomas, Executive Director,AHPI

CONFIRMED PANELISTS: PATIENT-DRIVEN INNOVATION IN BUSINESS MODELS 1. Chayan Chatterjee, Co-Founder & COO, Lattice Innovations, and India Partner, CamTech 2.Vishal Bali, Senior Healthcare Advisor,TPG Growth in Asia & Founder Medwell Ventures 3. Dr Nagarjun Mishra, Chief Officer - Business & Strategy & Co-founder, Purple Health 4. Suresh Satyamurthy, Founder,Tarnea Technologies

CONFIRMED PANELISTS: BALANCING PROFITABILITY WITH RESPONSIBILITY 1.Joy Chakraborty, COO, Hinduja Hospital 2.Viren Shetty, Senior - VP, Strategy and Planning, Narayana Hrudralaya, Bengaluru 3. Dr Alok Roy, Chairman, Medica Synergy, Kolkata

exhibitors

conference tracks

Pre-fixed appointments Industry awards

4. Dr Sabahat Azim, CEO, Glocal Healthcare Systems 5. Dr Ram Narian, Executive Director, Kokilaben Dhirubhai Ambani Hospital

CONFIRMED PANELISTS: RAISING CAPITAL FOR HEALTHCARE 1. Rana Mehta, Partner – Healthcare Practice, PwC 2.Apoorva Patni,Director, Currae Healthtech Fund (Investor and hospitals) 3. Dr K Krishna Reddy, Senior VP, CARE Hospitals 4. Dr Harish Pillai, CEO,Aster Medcity

showcase featuring leading IT providers, the Express Healthcare Excellence Awards in the private sector, prefixed peer-topeer networking and relationship building (gala dinners, excursions and entertainment).

Healthcare Senate would see discussions on pivotal topics such as: ◗ Sustainable Healthcare Delivery Models for the Future ◗ Balancing Profitability with Responsibility

◗ Raising Capital for Healthcare ◗ Dealing with Cost Burden of Medico Legal Tangles, ◗ Protecting Brand Image: How Intangibles Impact the Bottomlines ◗ Managing Human Capital in

and industry leaders for their vital contributions to healthcare in India. It seeks to honour the pathfinders, innovators and game changers from within the private healthcare industry.

The Association partners for the event are Association of Healthcare Providers India, Consortium of Accredited Healthcare Organisations and Karnataka Imaging Education Foundation.

EP News Bureau-Mumbai

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The 4th Edition of PharmaTech Expo 2016 to be held in Ahmedabad The expo will take place from August 21 to 23, 2016 THE 4TH Edition of PharmaTech Expo 2016, will be held at Gujarat University Convention, Centre, Ahmedabad from August 21 to 23, 2016. The event will be concurrently held with the second edition of Pack & Printech Expo and Pharma Ingredients & Chemicals. The expo will be organised by PharmaTechnologyIndex.com, a KNS Group of Company.

PharmaTech Expo 2016 will be an international exhibition on pharma, lab and packaging equipment.

A series of conferences will be held during all the three days. On August 21, 2016, Kapil Bhargava, Retired DDC, Govt of India, will give a lecture on ‘Training and Self Inspection,’ SM Mudda, former board member of Pharmexcil and Director Global Strategy (Technical), Micro Labs, will speak on ‘Introduction to Quality Management System.’

The following day will see Dr Vijay Singh Chauhan, Scientific Advisor, Sun Wave Pharma, Romania give an overview of Ayurveda for a Better Tomorrow: Blending Today’s Technology with Yesteryear’s Wisdom, ‘Cosmeceuticals: An Emerging Concept in Ayurveda’ by Dr SK Mitra, Matxin Labs, Bangalore, ‘Nanotechnology in Ayurveda: New Perspective and Current Need by Dr Vandana Patravale, Institute of Chemical Technology, Mumbai, ‘Regulatory Aspects and Accreditation of Ayurveda Products’ by Dr Narendra Bhatt, BVU College of Ayurved, Pune.

Express Pharma is the media partner for the event.

EP News Bureau-Mumbai

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

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August 1-15, 2016

MARKET GROWTH TRACKER

IPM registers ` 9162 cr in June 2016: IMS Health According to IMS Health, on a MAT June basis, the industry was valued at ` 107,019 crores and reflected a growth of 13 per cent THE GLOBAL pharmaceutical market in May 2016 was valued at $943 billion growing at two per cent. The US continues to dominate the market with 47 per cent market share at 10 per cent growth.

Amongst the top 15 market, India was ranked 11th and had grown at six per cent in the year ending in May 2016.

Indian companies hold 2.5 per cent share in the global market and growing faster than the global market. Amongst the top five Indian companies, Lupin and Aurobindo grew at 13 per cent and four per cent respectively for the year ending May 2016.

IPM in June 2016 Moving to our domestic market, the Indian Pharmaceutical Market (IPM) was valued at ` 9162 crores in the month of June 2016 clocking a 9.6 per cent growth over the same period last year (SPLY). This was seen revival on track after a dip in growth was observed in earlier months of 2016 post the ban imposed on 344 FDCs by the Government of India which affected the buying patterns in the market. On a MAT June basis, the industry was valued at ` 107,019 crores and reflected a 13 per cent growth.

The retail channel is the largest channel in IPM contributing 84 per cent of the overall sales and reflects a nine per cent growth. The hospital and doctor channel contributed to 16 per cent of the overall sales and reflected a growth of 17 per cent on a MAT June basis. It is expected that the hospital channel will continue to report robust growth rates due to rapid capacity expansion in this space.

IPM has witnessed some big ticket M&As over the past few

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years. Despite this consolidation, the industry remains fragmented with top 10 players contributing 43 per cent of overall sales and reflecting a robust 11 per cent growth for the month of June 2016. Companies ranked 1120 contributed 21 per cent of total revenues for the month reflecting a growth of 10 per cent aided by strong growth posted by Wockhardt (23 per cent), Glenmark (19per cent), USV (18 per cent), Aristo (17 per cent) and Intas (16 per cent).

Among top 10 companies, Cipla, Mankind, Alkem, Macleods, Lupin and Intas have registered a growth higher than IPM while among 11-20 companies, DRL, Aristo, Emcure, USV, Glenmark reflect a growth lower than IPM for the month.

Among top 25 companies, Lupin, Sanofi and Unichem have gained one rank each and moved to seventh, 15th and 24th rank respectively in comparison to previous month.

Domestic companies continued to dominate the market with a 78 per cent share in June 2016 with a growth of 10.6 per cent. MNCs reflected a modest growth of 5.3 per cent as large MNCs like Abbott, GSK and Pfizer who contribute to 56 per cent of the total MNC share in the month reflected low growth of eight per cent, three per cent and minus four per cent respectively.

Acute therapies remained the pillar of IPM with a 66 per cent contribution to the total market for the month. Chronic therapy areas have outpaced acute therapies consistently in terms of growth at 10.7 per cent for the month vis-Ă -vis a nine per cent growth for acute therapy areas.

Anti-infective was the largest Therapy Area (TA) for

TABLE 1: PHARMA MARKET SIZE IN MN $ BY COUNTRY All values in Mn USD

May 2016 (Month)

Month Growth per cent

MAT (May 2016 Month)

MAT growth per cent

GLOBAL PHARMA MKT

70702

-2.4

943473

2.4

USA

34960

9.3

439052

9.7

JAPAN

6117

13.2

76750

2.7

CHINA

6181

5.3

74210

2.3

GERMANY

2836

-6.8

39318

-6.2

FRANCE

1802

-27.3

31595

-10.5

ITALY

1041

-53.9

26783

-1.1

UK

2103

3.8

25973

3.9

SPAIN

924

-45.4

20069

-0.1

CANADA

1661

1.8

19026

-7.1

BRAZIL

1740

-2.5

18524

-19.3

INDIA

1235

5

14700

6.2

VENEZUELA

1321

33.4

13519

27

AUSTRALIA

1146

24.7

11272

-4.2

TABLE 2: INDIAN COMPANIES MARKET SIZE IN THE GLOBAL MARKET INDIAN COMPANIES MARKET SIZE

May 2016 (Month) 1951

Month Growth per cent -1.2

MAT (May 2016 Month) 24944

MAT growth per cent 6.4

SUN PHARMA

307

13.5

3558

-3

LUPIN

283

37.1

3054

12.5

DR REDDYS LAB

182

-14.2

2604

-2.9

AUROBINDO

131

-1.6

1833

3.9

ZYDUS CADILA

110

-14.8

1548

2.6

GLENMARK

101

-11

1326

3.5

INTAS

76

-14.1

1218

11.4

TORRENT

94

-1.6

1170

11.7

CIPLA

77

5.4

958

7.5

HETERO DRUGS

45

-14.1

731

93.6

ALKEM

52

5.8

630

12.1

WOCKHARDT

40

-18.6

576

-8.4

All values in Mn USD

Company

No. of Brands in Top 300 (June 2016)

Value. of Brands in Top 300 in June 2016 (Rs. Crores)

Growth

2015

2016

2015

2016

SUN

27

29

206

257

25 per cent

ABBOTT

27

28

271

301

11 per cent

CIPLA

22

23

155

187

21 per cent

PFIZER

17

16

165

159

-4 per cent

GLAXOSMITHKLINE

14

15

163

180

10 per cent

ALKEM

14

15

130

155

20 per cent

ARISTO PHARMA

10

11

90

105

17 per cent

SANOFI

12

11

101

109

8 per cent

MANKIND

9

11

65

86

31 per cent

ZYDUS CADILA

12

11

77

77

0 per cent

Source: imshealth

MARKET the month with a revenue of ` 1142 crores reflecting a nine per cent growth vis-Ă -vis a four per cent growth reflected in the month of May on the back of a good monsoon seen by the country. 15 per cent of the AI portfolio was impacted by the FDC ban while it was also one of the largest TAs to be affected by the NLEM notification. Amoxyclav solids and liquids reflected a strong growth of 22 per cent and 25 per cent respectively while Meropenem remained one of the fastest growing molecules with a 21 per cent growth for the month.

Cardiac was the second largest TA for the month of June 2016 clocking a revenue of ` 1084 crores growing at seven per cent driven by Rosuvastatin (13 per cent growth), Amlodipine+ Telmisartan (11 per cent growth), Telmisartan being affected by NLEM reflected a modest growth of six per cent for the month while largest statin Atorvastatin reflected a growth of minus one per cent.

Gastrointestinal was the third largest TA in IPM garnering a revenue of ` 1057 crores and a growth of nine per cent for the month. Ranitidine solids had a strong growth of 19 per cent driven by its 300 mg SKU for top companies, Domperidone combinations with PPIs like Omeprazole, Pantoprazole and Rabeprazole reflected consistent growth trends with 12 per cent, 10 per cent and eightper cent growth respectively.

Dermatology continued to reflect robust growth momentum with high NI activity in the Itraconazole space reflecting in a 180 per cent growth for the molecule in the month. Evergreen market of emollients and protectives grew at 16 per cent for the month while Clotrimazole reflected a strong growth of 20 per cent owing to a good monsoon season creating an environment for fungal infections.

Among chronic TAs, anti-diabetic and neurology were the fastest growing TAs, growing at 16 per cent and 11 per cent for the month respectively. DPP4 inhibitors and glim+ met formulations spearheaded growth for the anti-diabetic market owing to rising prevalence, diagnostic and treatment rates of diabetes.

In the neurology space,

Levetiracetam was the largest and fastest growing molecule for the month clocking a value of ` 40 crores with a growth of 25 per cent in June 2016. Escitalopram plain and its combination with Clonazepam found place among the fastest growing Central Nervous System

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(CNS) molecules for the month with a growth of 14 per cent and 13 per cent respectively.

With regulatory environment and new launch approvals getting more stringent over time, companies have focused on brand building. Top companies have driven higher

growth with large brands with only Zydus, Sanofi, and Pfizer reflecting single digit growth/de-growth for their portfolio which falls under the top 300 brands in the month of June 2016.

(Since the global data gets released at the end of the following

month while India data is released three weeks prior to that, the report for global data is for the month of May and for India is June. IMS Health is a leading global information and technology services company providing end-to-end solutions to the life sciences and healthcare industry).

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PHARMATECH EXPO 2016 Date: August 21-23, 2016 Venue: Ahmedabad Summary: The fourth Edition of 'PharmaTech Expo 2016, a PharmaTechnologyIndex.com venture will organise a pharma expo, which will be concurrently held with 'Pack & PrinTech Expo' and introduction of 'PIC India Expo.' More than 150 exhibitors will participate.

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Date: August 29 - 30, 2016 and August 31 - September 1, 2016 Venue: The Westin- Mumbai and The Park- Hyderabad Summary: The event will be a practical guide with highly qualified workshop trainers who are well qualified to provide unique insights and authoritative debate around techniques and strategies for

Date: September 22-24, 2016 Venue: Hyderabad Summary: Healthcare Senate, the national private healthcare business summit would host the game changers, path finders and and opinion leaders of the healthcare industry, to facilitate sharing of innovative ideas and experiences, and convert them into reality.

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The event will see a largest gathering of India’s most influential healthcare practitioners; CEO/CFO/MDs of hospital chains, medical superintendents, hospitals owners and decision makers, owners of single specialty hospitals, owners of diagnostic and other healthcare centres, hospital administrators, HoD of medical and bio-medical departments, HoD of engineering and operations, medical directors, purchase managers, healthcare consultants, project heads, bio-medical engineers, dealers and distributors, thought leaders, industry stalwarts and domain experts

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7TH ANNUAL PHARMA SCM Date: September 1 - 2 Venue: Mumbai Description: 7th Annual SCM Pharma Confex is the biggest

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conglomerate of supply chain experts from leading Indian pharma companies and supply chain and logistics solution providers to create avenues for better pharma supply chain solutions and infrastructure for the pharma industry.

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Opposite PNB Bank, New Delhi – 110033

BIOSIMILARS CONGRESS INDIA 2016 Date: October 13 – 14, 2016

Venue: Hyderabad Description: Biosimilars Congress India 2016 will aim to provide strategic solutions to key issues faced by the manufacturers around

the regulatory guidelines of FDA, EMA, upstream, downstream processing, identifying critical quality attributes and statistical approaches to demonstrate

biosimilarity.

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CGMP WORKSHOP Date: September 19 - 20, 2016 Venue: Mumbai Description: CPhI is announcing for the first time ever a ‘cGMP workshop’, a two day practical training to be conducted by a former US FDA drug investigator which would help companies to prevent instances of contamination, mix-ups, deviations, failures and errors to successfully meet the desired quality standards.

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2ND EDITION OF ASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotech, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons.

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22 EXPRESS PHARMA August 1-15, 2016

(

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BRACE FOR BREXIT Post-Brexit, a strategic realignment can help India emerge as a significant partner for pharmaceuticals in the both the EU and the UK

BY USHA SHARMA AND LAKSHMIPRIYA NAIR

B

ritain’s decision to break away from the European Union (EU) plunged the world into uncertainty and turbulence as evidenced by the plummeting global financial markets, fear of an economic slowdown, political turbulence and increasing clamour among other member nations such as France to exit EU.

Its ripple effects have been felt in India too. As a knee jerk reaction to the referendum's result, share prices of various leading Indian firms with sizeable businesses in the UK took a severe hit (Check table 1).

Predictably so, as our ties with the EU and the UK have grown considerably in the past few years. India's bilateral trade with the UK stood at at $14.02 billion in 2015-16, of which, ex-

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ports contributed $8.83 billion while $5.19 came from imports.

(Source: Commerce and Industry Ministry). India has emerged as the third largest investor in terms of number of projects in the UK. The total turnover of Indian businesses from the UK has grown from £22 billion in 2014 to £26 billion in 2015. (http://indianexpress.com/article/business/companies/brexitreferendum-fears-in-india-inc-

with-business-based-in-uk-andeye-on-eu-market-2874422/) Yet, the sentiments have undergone a significant change. The immediate panic has given way to cautious optimism, especially for certain sectors like pharma. The stock markets have rallied around and experts foresee several silver linings for India's growth.

Sectors like IT and automobiles may have to face some ad-

verse effects, but the pharma sector seems to be insulated against the fallout of Brexit.

Bucking the trend So, why is Indian Pharma Inc immune to Brexit blues? The figures speak for themselves.

India's pharma exports grew from $11.66 billion to $12.54 billion in 2015, recording a growth of 7.55 per cent, as per Commerce and Industry

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Since British pound has sunk to a 30-year low vis-a-vis the US dollar, this is a good opportunity for Indian pharma majors to explore M&A and licensing opportunities with small and mid-size British pharma companies with innovative products

The exposure of Indian pharma companies to Europe is fairly limited (i.e. top-10 companies generate only six per cent of revenues).

Accordingly, the impact of Brexit is modest

“It will not affect Suven at all since our exposure (to the EU and UK markets) is less, it is mainly in terms of US dollars Venkat Jasti Chairman & Chief Executive Officer, Suven Life Sciences

Subrata Ray

Majority top Indian pharma companies have low revenue dependence on the EU, especially from the UK. As a result, these companies are likely to face limited impact of the currency devaluation following the Brexit referendum results

Group Vice President, ICRA

Dr Ajit Dangi

Sameer Walia

President & Chief Executive Officer, Danssen Consulting

Ministry data. However, pharma exports account for only 12 per cent of the total exports to EU from India, of which just 3.5 per cent is UK's share. As a result, experts and the industry both feel that India's pharma sector will not have to face long lasting damage due to Brexit.

Sameer Walia, Managing Director, The Smart Cube, avers, “Majority top Indian pharma companies—Aurobindo Pharma, Cadila, Cipla, Dr Reddy’s Laboratories, Glenmark, Lupin and Sun Pharma— have low revenue dependence on the EU, especially from the UK; in fact, the US is the key market for most of them. As a result, these companies are likely to face limited impact of the currency devaluation following the Brexit referendum results.” (Check Table 2) The Smart Cube is a research and analytics firm.

24 EXPRESS PHARMA August 1-15, 2016

Managing Director, The Smart Cube

Indo-UK bilateral trade (2015-16)

$14.02 billion Total pharma exports (2015-16 )

$13 billion Pharma exports to the EU from India is

12%

of the total exports

Pharma exports to the EU and the UK in 2015-16

EU: $1.5 billion UK: $469 million ICRA, an Indian credit ratings agency, also predicts that Brexit would have a very marginal impact on the Indian pharma sector. Subrata Ray, Group Vice President, ICRA,

states, “The exposure of Indian pharma companies to Europe is fairly limited (i.e. top-10 companies generate only six per cent of revenues). Accordingly, the impact of Brexit is modest.”

Dr Ajit Dangi, President & Chief Executive Officer, Danssen Consulting holds similar views. He says, “Prima facie it appears that Brexit will have limited impact as India's exports to the UK are only 0.4 per cent of India's GDP. Total pharma exports in 2015-16 were $13 billion of which EU was $1.5 billion and UK was $469 million. Whereas our exports to the US were $5.02 billion. So, the impact on pharma exports is minimal, about `400 - 500 crores.”

Most of the Indian pharma majors endorse these views and believe that Brexit would have marginal impact on their growth trajectory.

Ramesh Swaminathan, Chief Financial Officer, Lupin points out, “Since Lupin’s European business contributes less than four per cent of the company’s total revenue, Brexit has seen no impact on

our business.”

Venkat Jasti, Chairman & Chief Executive Officer, Suven Life Sciences also reiterates, “It will not affect Suven at all since our exposure (to the EU and UK markets) is less, it is mainly in terms of US dollars.

However, wariness exists due to falling GBP. Jitendra Sharma, Chief Financial Officer, Marksans Pharma, a firm with considerable business presence in the UK says that there would be no impact on business in terms of volume.

However, realisation and margins may come down due to weakening GBP. Glenn Saldanha, Chairman and Managing Director, Glenmark also states, “We have seen an instant weakening of pound, which will have its impact on various businesses, and for the pharma industry in Europe.”

Dangi also cautions, “The

(

THE MAIN FOCUS

profitability in the European markets has been low on account of tenderisation/price cuts and increasing thrust by governments to reduce healthcare cost. As a result, depreciation of GBP/Euro may further impact profitability of European business.”

However, this could prove beneficial for companies like Biocon who have significant exposure to the US market and only marginal presence in the UK. As Kiran Mazumdar Shaw, Chairman & Managing Director, Biocon informs, “Biocon does not have any exposure to the pound sterling. Brexit impact has weakened pound sterling, as a result the US dollar has emerged stronger.

This will benefit us since we are net USD earners. For euro exposure, we have hedged our revenues for next 18 months at higher rates.”

The silver linings Thus, uncertainties have been counterbalanced with opportunities and advantages. The experts and industry veterans are identifying several silver linings in what was earlier seen as a dark cloud on the horizon of Indian pharma sector's progress path.

Some of the other notable growth areas for Indian Pharma Inc would be: M&As—Window of opportunity: Falling GBP could signal a good time for Indian firms to expand their footprints through M&As, feel the experts. Swaminathan explains, “This might just open up a window of opportunities when it comes to an Indian pharma company that might be looking at acquisitions to expand in to the EU and Great Britain, as assets might become relatively cheaper because Brexit will lead to weaknesses in these markets in the short or the midterm.”

Dangi supports this view and says, “Since British pound has sunk to a 30-year low vis-avis the US dollar, this is a good

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The rising cost of healthcare has been a source of concern in the UK. For Indian pharma companies this represents an opportunity as the need for economical generic drugs is being felt

India’s strengths in drug development and UK’s strong innovation ecosystem can be key to realising the vision of addressing unmet medical needs through affordable medicine globally

Javin Bhinde

Kiran Mazumdar Shaw

Managing Director and Chief Executive Officer, SynCore Consulting

Chairman & Managing Director, Biocon

opportunity for Indian pharma majors to explore M&A and licensing opportunities with small and mid-size British pharma companies with innovative products.”

Growth in generics prowess: India could also look at becoming a major generic medicines provider to the UK as it looks to expand funding to enhance its National Health Service (NHS).

Javin Bhinde, Managing Director and Chief Executive Officer, SynCore Consulting elaborates, “One of the causes for the strength that the referendum gained was the oft repeated line by the United Kingdom Independence Party (UKIP), ‘We send the EU £350m a week, let's fund our NHS instead.’ The NHS is one of the world’s largest publicly funded health services and provides healthcare in the UK. The rising cost of healthcare has

26 EXPRESS PHARMA August 1-15, 2016

We have seen an instant weakening of pound, which will have its impact on various businesses, and for the pharma industry in Europe.

Glenn Saldanha Chairman and Managing Director, Glenmark

This might just open up a window of opportunities when it comes to an Indian pharma company that might be looking at acquisitions to expand in to the EU and Great Britain, as assets might become relatively cheaper Ramesh Swaminathan Chief Financial Officer, Lupin

TABLE 1: SHARE PRICES OF INDIAN PHARMA MAJORS ON JUNE 24, 2016 Name of the company

Share Price (Rs)(on June 24, 2016)

Down by %

Lupin

1462.65

1.50%

Dr Reddy's Laboratories

3149.55

0.67%

Glenmark Pharma

766.2

1.12%

Torrent Pharmaceuticals

1323.8

1.53%

Aurobindo Pharma

700.95

3.50%

(Source – Bombay Stock Exchange Dated 24 June 2016)

been a source of concern in the UK. For Indian pharma companies this represents an opportunity as the need for economical generic drugs is being felt.”

Lower operating costs in UK: Mazumdar Shaw identifies another area of benefit for Indian pharma firms. She feels that the possible softening of commodities prices due to Brexit could positively impact us in lowering operating costs for ex-

penses linked to crude oil prices. Sharma also points out this benefit and says that local manufacturing in the UK may become cheaper and export out of the UK may gain.

Emerge as an innovation partner: Mazumdar Shaw also sees an opportunity for India to emerge as a global innovation hub for the pharma sector. She opines, “UK has been an innovation hub for EU,

with the complexities emerging post-Brexit, India stands a chance to be the next innovation partner for the global pharma companies.”

Elaborating further, she states, “Indian pharma companies have already sharpened their focus on original drug discovery and are offering high quality, low-cost scientific talent pool and end to end discovery and development services

for both small and large molecules. In a post-Brexit era, India can leverage this expertise to tap the global CRO market for discovery services that is expected to grow at a CAGR of 11.5 per cent to reach $23 billion in 2018 up from $15 billion in 2014.”

“UK’s innovation ecosystem will continue to create opportunities for Indian companies to develop new competencies through collaborative research and drug development alliances with companies there. India’s strengths in drug development and UK’s strong innovation ecosystem can be key to realising the vision of addressing unmet medical needs through affordable medicine globally,” predicts Mazumdar Shaw.

Lesser trade barriers to global markets: The UK has traditionally served as a gateway to Indian companies seeking access to the entire EU.

( However, with its exit, other European nations would see an opportunity to attract Indian businesses that earlier would have chosen to invest in Britain.

In fact, countries like Belgium and Hungary have already implemented measures to attract Indian players.

Bhinde informs, “Countries like Belgium have greatly simplified tie-ups and collaborations with Indian companies, including the formation of an exclusive executive body for Indian trade partners to acquire local partners, land, infrastructure, labour, power etc. Belgium has also repeatedly expressed the intent to be a more sizeable trade partner to India and can be a potential hub for Indian companies intending to manufacture in the EU.” Hungary too has expressed interest in incentivising Indian firms who might chose to leave the UK after the referendum.

Peter Szijjarto, Minister of Foreign Affairs and Trade of Hungary, who was in New Delhi recently, informed that Hungary is looking at partners like India for mutual progress and promised incentives, assistance or subsidies to companies choosing to invest in his country.

Improve Indo-UK ties: The UK too is very interested in fortifying its business ties with India. Recently, Sajid Javid, UK Business Secretary was in discussions with Nirmala Sitharaman, Commerce and Industry Minister, India to devise ways to strengthen Indo-UK trade and economic ties. Drawing his inferences, Bhinde says, “In a recent interview, Sitharaman has expressed the desire to discuss the issue of access being granted to Indian generic drugs to the European market in the coming days. The government has already expressed to offer the European trade bodies access to Indian markets in wine, auto etc. to negotiate better terms for the pharma industry.

If successfully negotiated, this

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There will be intense competition from a number of EU countries for the EMA HQ but Ireland's status as an English speaking country with an extremely strong cluster of biopharma and medical device companies puts it in a strong competitive position

The global appetite for Scotland’s products and services has not diminished, nor has our strengths as a strong and resilient economy and a great place to invest. Our Business Helpline is ready to assist with any immediate advice to business

Viewing the new composition of the EU, after Brexit, Germany with 17.5 per cent of the share and Netherlands with 12.2 per cent share are top two exporting partners. Both the UK and Germany are pioneers in pharma research and innovation.

There would be no impact (of Brexit) on business in terms of volume. However, realisation and margins may come down due to weakening GBP. However, local manufacturing in the UK may become cheaper and export out of the UK may gain

Tanaz Buhariwalla

Rooma KR Bussi

PV Appaji

Jitendra Sharma

Director India, IDA Ireland

Country Director, Scottish Development International, India

Director General, Pharmexcil

Chief Financial Officer, Marksans Pharma

could represent a whole new market being opened up.”

Scotland and Ireland who were part of the ‘Bremain’ campaign are also eager to minimise the fallout of Brexit.

“Scotland voted to remain in the EU and the Scottish Government is now seeking to negotiate with EU institutions and other EU member states to explore all options to secure Scotland’s interests. It is currently firmly in the EU and trade and business should continue as normal to maintain the country’s position as an attractive and a stable place to do business,” clarified Rooma KR Bussi, Country Director, Scottish Development International, India.

“Scottish Enterprise’s focus and role remains firmly on the Scottish economy and we are working closely with the Scottish Government to ensure we are able act quickly as the situ-

28 EXPRESS PHARMA August 1-15, 2016

TABLE 2: EXPOSURE OF INDIAN PHARMA COMPANIES TO EU/UK Company

Percentage of Sales Exposed to EU/UK

Aurobindo Pharma

1.5% (UK)

Cadila Pharma

3% (EU)

Cipla

4.5% (EU), including <1% (UK)

Dr. Reddy's Laboratories

11% (EU)

Glenmark Pharma

9.5% (EU); 2.5% (UK)

Lupin

3% (EU)

Sun Pharma

4% (EU)

Source: Bank of America Merrill Lynch

ation becomes clearer. So, whilst we know change is on the horizon, we also know the global appetite for Scotland’s products and services has not diminished, nor has our strengths as a strong and resilient economy and a great place to invest. Our Business Helpline is ready to assist with

any immediate advice to business,” states Bussi further.

“We think it is too early to say but certainly this could make the UK less attractive for companies from India or elsewhere looking to establish an EU hub for regulatory affairs and clinical/commercial activities,” says Tanaz Buhariwalla,

Director, India for IDA Ireland.

Highlighting Ireland’s suitability as an EU hub, Buhariwalla expounds, “Ireland is one of a number of potential locations to which the EMA might relocate once the Brexit process is finalised. There will be intense competition from a number of EU countries for the

EMA HQ but Ireland's status as an English speaking country with an extremely strong cluster of biopharma and medical device companies puts it in a strong competitive position.”

She says, “Ireland has for many years been winning a very high market share of mobile FDI coming into Europe in the life sciences space. IDA continuously seeks to ensure Ireland's value proposition for life sciences FDI is compelling and highly competitive.”

Thus, Brexit could actually churn out several advantages for India and its progress. Yet, leveraging these opportunities would require strategic realignment on varied fronts.

There are a few challenges which would need to be tackled effectively to optimise the growth potential such as: Tackling regulatory tangles: Dealing with regulatory delays and complexities would be one

(

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of the major challenges for drug companies, as European Medicines Agency (EMA), which approves treatments for all EU countries, and has its headquarters in the EU may have to relocate post-Brexit.

As Mazumdar Shaw points out, “Since EU regulatory framework will not be applicable to UK post-Brexit, Indian pharma companies have to wait and watch how the UK guidelines and regulatory frameworks emerge.”

Dangi also reiterates, “Regulatory impact is another important issue for Indian pharma companies exporting to the UK. Since European Medicines Agency (EMA) is headquartered in London, which acts as one-stop-shop for the EU approvals, India may lose the advantage of harmonised regulatory policies across

India would face some as the aftermath of Brexit, yet a world of opportunities await the EU for product approval, quality compliance, clinical trials as well as IPR.” However, steps are being implemented to prevent regulatory delays and tangles.

A steering group, comprising global pharma majors and co chaired by Andrew Witty, CEO, GSK; Pascal Soriot, CEO, Astra Zeneca and Life Sciences Minister George Freeman, has been formed to ensure that the UK pharma industry does not have to face bureaucratic hurdles. It could prove beneficial to the Indian pharma companies with presence in the UK as well. Talks between India and the UK for a free trade agreement have already been initiated.

Meeting stringent quality standards: Quality concerns have plagued the Indian pharma industry for quite some time now.

It would be very important to lay doubts about the quality of medicines from India to rest for ensuring optimal use of the growth potential offered by Brexit.

Bhinde highlights, “The challenge for Indian companies is to sustain the stringent requirements of the European and British markets to become major players there.”

He recommends, “Companies must focus on creating state-of-the-art products, packaging and services capable of smoothly integrating with European healthcare sys-

tems where track-and-trace systems, serialisation etc. are already deployed.

Scout for lucrative EU markets: With the UK no more an entry point to the EU, Indian Pharma Inc will have to build ties with the other member nations to gain a stronghold in the EU. This would mean that the players will have realign their strategies to build bases in other EU countries.

Dangi suggests, “We will have to also start looking at other European countries like Germany, France, Italy etc. to gain entry in to the EU markets as these countries have large pharma markets. (total EU market - €220 billion in 2014).

Studies show that countries having large container ports, high level of healthcare expenditure as percentage of GDP and FTAs attract more pharma imports.”

PV Appaji, Director General, Pharmexcil suggests that Germany and Netherlands could be good options as gateways to European markets. He highlights, “Viewing the new composition of the EU, after Brexit, Germany with 17.5 per cent of the share and Netherlands with 12.2 per cent share are top two exporting partners. Both the UK and Germany are pioneers in pharma research and innovation. Market behaviour is almost similar and Germany has recently switched over to international nonproprietary names (INN) from branded generics.”

Fortunately, the pharma industry too seems geared to maximise growth potential arising out of Brexit. Swaminathan informs, “We are looking at standing presence in Europe, specifically in Russia, Poland and Eastern Europe. The company remains committed to growing its existing European businesses in the markets of Great Britain, Germany and its partnered businesses in France.”

The road ahead Thus, while there are some challenges that the country would have to face as the aftermath of the UK-EU divorce, yet a world of opportunities await. A strategic alignment by the industry players with adequate support from the government could make India a leading pharma powerhouse and accelerate its growth trajectory significantly. u.sharma@expressindia.com lakshmipriya.nair@expressindia.com (With inputs from Viveka Roychowdhury)

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MANAGEMENT/SERIALISATION

Pharma companies across the world are racing against time to meet the November 2017 deadline of the US DSCSA followed by the February 2019 deadline of the EU Delegated Act. Are Indian companies ready for the complexities of serialisation?

VIVEKA ROYCHOWDHURY

30 EXPRESS PHARMA August 1-15, 2016

2019 EU DELEGATED ACT

2017 US DSCSA

B

y the end of this decade, industry estimates indicate that more than 80 per cent of all pharmaceutical products available globally will have rolled off a packaging line that has serialisation at the tertiary level, i.e. bottle/strip/vial level.

Some companies are well on track to meet these deadlines.

For instance, in late June, Recipharm, a global contract development and manufacturing organisation (CDMO), announced the formation of a global partnership with Marchesini, SEA Vision and TraceLink to introduce new serialisation capabilities. According to a press release, this marked the next step

in the global CDMO’s plans to invest €40 million over the next three years to ensure state-ofthe-art solutions for serialisation processes.

However, Kjell Johansson, President Manufacturing Services Europe, Recipharm sounds a cautionary note for pharma companies in India. He says, “In general, pharma companies need to place serialisation higher up on their agenda in order to meet the US and EU deadlines. Many companies are not currently aware of the scale and complexity of the task ahead. While the EU 2019 deadline is three years away, the European Stakeholder Model (ESM) suggests that four to five

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There is a degree of legislative complexity that must be effectively managed and this will be a challenge for pharma companies in India Kjell Johansson President, Manufacturing Services Europe, Recipharm

years is a more realistic timeframe. As many manufacturers have a number of markets they need to address, ranging from

the EU and US to South America and Asia, there is a degree of legislative complexity that must be effectively managed and this will be a challenge for pharma companies in India. Many companies are also concerned about the financial investment involved. Hence, our novel pricing model to reduce upfront investment costs."

Most of the bigger Indian companies are gearing up to the serialisation challenge and this is attracting global serialisation solution providers like Optel Vision to expand their presence in the country. (See story on pages 35-38). The good news is that solution providers are tailoring their products for the India mar-

ket. For instance, in partnership with a top-ten global pharma company, Antares Vision, yet another provider of serialisationbased track and trace solutions, which is reportedly currently in the process of launching a pilot project in India, is developing a leaner, more cost-effective serialisation solution for the Asian subcontinent that performs onpar with European standards and mandates. The goal is to implement track and trace in India that is forward-thinking in terms of ‘pre-meeting’ inevitable regulatory requirements, according to the company.

Will these offerings convince pharma companies in India to commit to serialisation?

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MANAGEMENT/SERIALISATION INSIGHT

Serialisation world – A global regulatory canvas

ARJUN GUHA THAKURTA, Director – Operations, Life Science Consulting

Arjun Guha Thakurta, Director – Operations, Life Science Consulting, (a Convalgroup Company) gives an insight about the impact of serialisation programmes on pharma companies

S

erialisation regulations issued by 20+ countries in a span of last six years has impacted the supply chain of pharmaceutical business in a way which was not foreseen by the industry in the last 200 years of its existence.

In the past 12 months, corporate board rooms of small and large pharma companies across the world are abuzz with discussions on serialisation programme across the enterprise and their contract manufacturer organisation (CMOs). Also in the list are mind boggling estimated budget for compliance, tight implementation timelines, lack of skilled resources, a handful of less than 20 track and trace vendors and a laundry list of pain points, risks and issues listed daily on the project risk register. All this being done without any tangible return on investment (RoI) foresee in the near future.

Rarely, had there been an occasion when the industry is at the cross-roads of appropriately justifying the real purpose of the investments and the value addition in further enhancing product quality and patient safety, when the industry actually, had been selling products across the world for centuries. The distribution hubs, external distribution centres, wholesalers and pharmacies who had, so far, been involved in only the physical flow of products, are new to the serialisation data exchange concept.

These agencies have already

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started declaring that they will not live in a hybrid world where there are stocks of nonserialised and serialised products in the supply chain.

The general outcome of parochial management vision results in selection of low-cost track and trace vendors from the local market with little or no experience of the global regulations impacting such electronic data intensive systems.

This has further precipitated the issues and risks faced by the industry. Moreover, the serialisation data are being reported in various government data portals (like DAVA, EMVO, US, China, Turkey etc.). These electronic data are also GxP data and therefore becomes open for scrutiny and audits by the FDA and other global regulators.

The theory of track and trace In distribution and logistics of many types of products, track and trace or tracking and tracing, concerns a process of determining the current and past locations (and other information) of a unique item or property. The arrival or departure of the object is observed followed by its identification, the location where it was observed, with recording of the time and status. Then the task of the system is to collate all the informations obtained at various locations and at different times into a coherent pattern detailing the movement of the object.

It is often said that we track objects forwards, in a

Simple print and verify unit

proactive manner, while we trace products backwards in a retrospective manner.

Tracking within the supply chain offers: ◗ Control of distribution channels ◗ Recall management ◗ Stock management (expiry date) ◗ Anti-counterfeit (brand protection)

Tracing offers ◗ Origin of product ◗ Authentication of product The suggested code for track and trace is a GS1 Data Matrix code and contains four elements of information i.e.

GTIN, batch number, expiry date and unique serial number. The combination of GTIN and Unique Serial Number provides the pack’s unique identity.

In almost all regulations published till now, serialisation of the carton box (secondary packaging level) is a mandate. Only for India Export (DGFT) and the US, serialisation of the primary pack is applicable. The India exports regulation is not obligatory at this moment. However, in the US, as most of the saleable packs are in bottle form, US DSCSA applies to the primary pack which is the bottle.

For Brazil, China, India and Turkey where aggregation or parent-child relationship is a requirement, although no regulation obliges to serialise bundles, bundle serialisation is the option to facilitate aggregation and logistics track and trace. Approximately 50 per cent of the industry also aggregates the pallet and is again found most commonly in the countries mandating aggregation. The key driver for implementing aggregation is National Portal Reporting compliance and/or facilitate operations in the warehouse or downstream supply chain track and trace.

The US will request full track and trace by 2023, however,

nearly 50 per cent of the US pharma industry already plans to have these capabilities implemented by 2018.

In the EU Directives and EU Delegated Act 2016, there are no requirements for aggregation of products to shipper cases and pallets. Also, for products, there are no traceability requirements in the supply chain, only a verification process at the point of dispensing is sufficient. However, there is one paragraph in the regulation, where many questions : “The verification by wholesalers of the authenticity of medicinal products at high risk of being falsified would be equally effective whether performed by scanning individual unique identifiers or an aggregated code allowing the simultaneous verification of multiple unique identifiers. In addition, the verification could be performed at any time between the reception of the medicinal product by the wholesaler and its further distribution to equal results. For those reasons, it should be left to the choice of the wholesaler whether to scan individual unique identifiers or aggregated codes, where available, or the timing of the verification, provided that the wholesaler ensures the verification of all unique identifiers of those products at higher risk of falsification in his physical possession, as required by this regulation.”

European Pack Coding Guidelines from EFPIA specifies the requirements for

MANAGEMENT/SERIALISATION

A closer look at the data matrix

non-deterministic random serial numbers. ◗ The alphanumeric range shall include the digits 0-9 and the letters of the western alphabet but exclude the following letters: i, j, l, o, q and u.

(I J L O Q U) to avoid confusion with similarly shaped characters. ◗ The serial number character string should only contain either lower case or upper case letters, not a mixture. ◗ Use of the extended symbols, as defined by the complete GS1 specification should ideally be avoided. ◗ The serial number will be unique per product code (i.e. not per batch or per product code-batch code pair).

Apart from this, in order to provide a reasonable level of complexity within the serial number, the probability that a valid serial number can be guessed should be less than 1 in 10,000 (i.e. < 0.0001). The randomi-

The universal issue identified with most manufacturing sites is the lack of adequate space for installation of serialisation system sation substrings of the serial numbers have to fulfil the following randomisation criteria. ◗ The randomisation substrings must be equally distributed. e.g. the serial number substring should not contain fixed blocks of fixed digits. ◗ Any randomisation substring must be independent of other substrings. ◗ The randomisation substrings must not be built using an algorithm that is easy to find out when knowing the given set of serials or a subset thereof. ◗ Serial IDs shall not be reused within the longer of a) Exp Date +1

year or b) five years.

Pharma exporters from India can take advantage of following the above-mentioned logic for random serial numbers for exports to all countries having serialisation laws except China.

Facilities bottleneck The universal issue identified with most manufacturing sites is the lack of adequate space for installation of serialisation system. A change in the facility layout of the packaging hall is a major setback, as this means production stoppage, civil work, replacement of HVAC system, re-qualification of the area and subsequently implementation of the track and trace system. In India more than 50 per cent+ manufacturing plants requires an expansion in their packaging hall to include a serialisation and aggregation workstation unit.

Additionally, the warehouses, logistics facilities and distribution centres also perform re-packing activities and will require re-aggregation setups within these facilities.

When looking at the project bottlenecks of today, a large number of business executives have indicated to have issues with vendor resources, project resourcing and with line level Software (HMI) and Site Server system. From a very small online carton serialisation unit to a highly sophisticated system including online check-weigher, print and verify unit integrated with tamper evident labellers, the line systems contributes initially to 80 per cent of the cost of the overall project.

The Indian supplier market is fragmented with a host of small and medium local suppliers who claim compliance via a 2D printer, a scanner and a laptop loaded with a software. The more sophisticated vendors provide a fully functional serialisation unit with automatic and manual aggregation stations. The global vendors carries a vast implementation history with multi-country, multi-regulation compliance experience. However, the cost of equipment of a global supplier is generally 30–40 per cent higher than the local supplier, making the initial

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MANAGEMENT/SERIALISATION equation simple for the pharma company’s procurement department as to whom to award the contract. However, in the past year alone productivity losses as high as 30 per cent was reported from many Indian companies due to issue faced with the serialisation equipment. Most of the issues and risks reported generally came from the small and medium local suppliers who did not have pharma validation experience and their custom software were not capable of aggregation. The lack of proper software development quality assurance and software code testing resulted in bugs which were either overlooked or once released, almost impossible to remediate. Most of these small and medium local suppliers lacked clear understanding of the GxP data integrity compliance mandates of US and EU.

toring, virus and malware protection, system access logs, physical and logical controls to ensure separation of data, as applicable and SLA clearly defining how provider will and will not access the system and its content.

Future steps

Tomorrowland The initial hype and loudspeak of ‘We are Ready with Serialisation’, having almost died down in the past few months, many pharma companies are now faced with the uphill task of meeting the US DSCSA mandate on or before November 2017 and later-on the EU Delegated Act target of Feb. 2019. India’s DGFT mandate of DAVA Reporting has also demanded a host of upgrades of the existing lines and additional investment into aggregation lines and reporting software. The key differences between India DGFT requirement and US DSCSA and EU FMD serialisation requirement are a. EU FMD mandates tamper evident packaging feature to ensure that the secondary carton is not tampered with till the point of sales at pharmacies. b. Compliance of the software with 21 CFR Part 11, 21 CFR 211.68, EC Annex 11 etc.

Tamper-evident features The key tamper evident feature label is made of fragile material and by tampering or opening or tearing off the label, it becomes irreversibly torn or broken and impossible to re-use. The application of

34 EXPRESS PHARMA August 1-15, 2016

Integrated online checkweigher + print and verify + tamper evident labeller unit with Bollini Labeller option

these labels on the box takes place after the serialisation printing and verification operation subject to the inkjet ink being already dried and that the application should not result in air bubbles between the label and the carton. In case of small boxes, these labels can cover the printed matter and may impact the scanability of the data matrix. Apart from this, transportation rattles, type of transport (air or sea), kind of storage conditions (temperature, humidity, etc.) may impact the adhesion of the label over the shelf life of the product. The interaction of the label glue and inkjet ink and patient handling (ease of opening of the label) needs format risk assessment, stability studies and design of appropriate test procedures.

Cloud compliance First time in the history of Indian pharma industry, serialisation cloud solution providers are actively scouting for managing the data and reporting requirements to various government portals across the globe with optimised on-demand solutions.

First time in the history of Indian pharma industry, serialisation cloud solution providers are actively scouting for managing the data and reporting requirements to various government portals across the globe

However, there is no way to audit the cloud hosting providers as the actual facilities are housed outside India and the customers are left with little choice in accepting the glass screen reports. Validation of cloud solutions is always a pain point for the QA as this topic is relatively new and risky. Mostly there is no formal process laid out for cloud qualification and validation. However, a closer look of the regulations as below will help the QA to evaluate the cloud hosting vendor according to the regulations.

21 CFR Part 11.10a – Control of closed systems - Provide documented, traceable, attributable evidence to demonstrate that data integrity requirements are met.

21 CFR Part 11.10c – Protection of Records - Physical and logical security, appropriate HVAC and fire protection controls, validated backup and disaster recovery.

21 CFR Part 11.10(d) - Limiting system access to authorised individuals - rigorous, multi-tiered physical security, facility access logs, logical access controls, system moni-

Serialisation implementation across various small, medium and large Indian pharma exporters are currently in progress or under completion.

However, thorough validation and extensive training had been one of the most neglected topics during the implementation. This is clearly evident by the large number of serialisation lines being commercialised within a very short span of time. This also does not mean that those who thoroughly validated their systems will never face any issues in future. The very nature of a mechanical hybrid system is subject to extreme wear and tear and rough handling which is not part of any validation exercise. These serialisation units have to be maintained in pristine conditions with regular preventive maintenance for both mechanical as well as data cleanup from time to time and therefore it is the best interest of the pharma company to build a Center of Best Practices (CBP) and a select super team who assumes the oversight responsibility and ensures that these serialisation systems are maintained in the perpetual- compliant state.

References 1. Public Notice No. 52/20152020, Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industries, Government of India.

2. European Medicines Verification System (EMVS) European Pack Coding Guidelines 3. European Commission Delegated Regulation (EU) 2016/161 4. EU Directive 2011/62/EU 5. GS1 General Specifications 6. The Drug Quality and Security Act of 2013 7. DSCSA Implementation: Product Tracing Requirements — Compliance Policy 2014

MANAGEMENT/SERIALISATION INSIGHT

Challenges of global track and trace: Holistic approach,common solution

SHAUNAK J DAVE, Asian Market Director, Optel Vision

The objective of global track and trace regulations is to protect patient safety by preventing counterfeit, diversion of products and to ensure product integrity across the complete pharma supply chain. Shaunak J Dave, Asian Market Director, Optel Vision, feels that this is a very significant challenge for Indian pharma industry having positioned itself as the global pharma manufacturing hub. This article gives insights on the present implementation challenges in the Indian context on how to select a reliable vendor with cost-effective India-centric solution to meet compliance and ensure business continuity and growth IN 2010, while talking to a prospective customer and trying to understand his needs, I was told: 'Mujhe to 2D print karna hai, bas! Nothing Else'

Industry transformation on track and trace: Then and now At that time, serialisation was all about tertiary, i.e. offline printing shipper (case) label, which could be done by buying a thermal transfer desktop printer and one scanner, using it offline and catering to multiple packaging lines.

Later, it was extended to secondary, i.e. adding an offline carton printing and inspection station to overprint 2D Data Matrix codes and human-readable characters (GTIN, batch numbers, expiry dates and serial numbers) on cartons (secondary packaging). The project was considered a packaging development project, and only one of two functional teams were involved.

But now, in 2016, what we have experienced is a huge paradigm shift. The knowledge of subject matter and approaches have drastically changed, compared to what they were in 2010. Thanks to our Indian mindset to learn continuously with global perspective and evolve with the times, the industry has realised that over-printing is just tip of the iceberg and started seeing what is underneath.

Six years ago, the industry was talking about batchspecific serialisation (French Regulation - CIP 13), but now, it's all about the challenges of aggregation on packaging lines, total track and trace architecture, scalability (to handle big volumes of serialisation/aggregation/transaction data across the supply chain network and rapid information exchange with trade partners, CMO and government efficiently) and, of course, the data integrity. The shift is clear whenever we meet any company where previously only a few people were involved in the project. And now, there are cross-functional teams consisting of production, packaging, validation, QA, IT, project management, regulatory, engineering and sales to meet the challenges of this complex compliance. We have experienced the noticeable attention from top management, as non-compliance means business loss.

However, aggregation is still undergoing a learning curve!

The Indian pharma industry has realised why leading global brands have made massive investments in this programme and has tried to understand their experiences and learnings, thus creating an Indian model of project implementation in a cost-effective way.

The objective of global track and trace is to fight

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China, Brazil, Turkey, Argentina, Saudi Arabia, Korea and the list goes on. The biggest challenge for Indian manufacturers is to have one common solution that can meet their present needs and have the scalability to meet future requirements.

Different standards (GS1/ non-GS1) and interpretations: Most countries have adopted GS1-based standards, but some have adopted nonGS1 standards. There are several data structures and communication protocols for data exchange that are yet to be standardised.

2D Barcode. Picture used for representational purpose only

Challenges of global track and trace for Indian pharma industry

global medicine supply by 2018/2019. Non-compliance of those regulations results in restrictions on market entry, which means business loss; and any false instance (false printing, missing printing, incorrect data etc.) would lead to penalties and product recalls. This challenge is becoming highly complex and critical for the Indian pharma industry, which exports to almost 200 countries around the world.

The Indian industry has been realising the extent of challenges like:

As we all are aware, track and trace regulations will cover more than 75 per cent of the

Diverse regulations: USA_ DSCSA, EU FMD, India,

against counterfeiting to protect patient safety, prevent deviations, and ensure product integrity across the total supply chain. However, there is still a lot of work to be done, on global scale and collectively, to attain that sublime objective.

Lao Tzu once said, "The journey of a thousand miles begins with one step.

This is just the beginning!

Moving timelines: The industry has experienced moving timelines for various regulations. This demands flexibility and quick adaptability to the situation in order to manoeuvre serialisation programmes with agility.

Artwork modification: Before the serialisation era, the overprinting was limited to batch numbers and expiry dates. But now, 2D + GTIN, batch numbers, expiry dates and unique serial numbers are required. If sufficient space is not available, either the packaging needs to be modified or the overprinting space has to be changed to a different plane of packaging. Aggregation also has an impact on artwork modification.

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MANAGEMENT/SERIALISATION Integration with existing packaging-line equipment Indian manufacturing companies have been using a wide variety of equipment — many brands, starting from top-end packaging machinery from Germany, to low-cost machinery from China. Integrating serialisation systems with existing equipment (especially with cartoner, labeller and case packer) and using existing printers (of course, it has to be serialisation-compatible) is very challenging.

Space constraints on production floor: Almost all the old plants have space constraints for additional serialisation/aggregation equipment. The biggest challenge is to select the best possible equipment and process, while minimising minimum line extensions. The latest trend is to build an integrated system that includes a checkweigher, TE labelling and carton printing, and inspection in the same machine, and/or minimise the carton print and inspection system as much as possible.

Multiple packaging configurations on the same line: Unlike the US and the EU, Indian companies have been utilising manual packaging lines, so that multiple packaging can be produced, and small lots can be supplied to export

markets very quickly. Very few lines are dedicated to one product, and frequent product changeover is observed.

With the introduction of serialisation and aggregation equipment, the line start-up time has also increased. With multiple packaging running on the same line, it further increases the complexity of aggregation.

IT architecture and infrastructure: Is it better to go for L2 (Line), L3 (Plant), L4 (Corporate), or L2 to L4? This demands a lot of deliberations and multiple considerations.

Another question is whether to go for an on-site solution or cloud-based solution. How can WH processes be integrated with enterprise-level serialisation servers and, most importantly, will the infrastructure be able to handle the storage of billions of EPC events, secure data exchange (from server to line and back, as well as with trading partners and government), operate with minimum down time, ensuring zero per cent data loss.

All computer-based systems work on the same principle: Garbage In – Garbage Out. If the generation of the data at the packaging line is not reliable and incorrect, the same will be exchanged and communicated across the partners and government.

COMPLETE BOTTLE LINE WITH AGGREGATION

36 EXPRESS PHARMA August 1-15, 2016

Aggregation: While implementing aggregation, the biggest challenge is the compromise of line efficiency. The selection of the right aggregation method also depends upon the line equipment, and the existing packaging process and configuration.

Which is the appropriate method, 'pack and scan' or 'scan and pack'? This is a very relevant question, and if the appropriate aggregation method is not chosen, it may significantly impact line efficiency. It has been also noticed in the industry that an improper selection on the right aggregation process resulted in a production loss of almost 30 per cent.

Multiple line-level solution providers and vendor-locking architecture: Most of the companies in India have been working with more than one packaging line vendor within a single plant or in different plants. This also imposes significant challenges for IT enterprise track and trace vendor integration. If the existing supplier's architecture is vendor-locking (cannot accommodate any other IT vendor or line vendor, etc.), this would be a significant issue.

Implementation cost: India is considered a low-cost production hub for generics.

Complying with those serialisation regulations further

adds to the cost of production.

To deploy the right solution in a cost-effective way is one of the biggest challenges.

Regulatory compliance and data integrity: It’s quite simple. Global track and trace is a compliance issue, and failure to do so will severely impact business. There is no escape, no compromise. The game in regulatory markets is completely different than in emerging markets.

Serialisation and aggregation is an integral part of your secondary packaging line.

Imagine if during the packaging, the equipment fails (duplicate serial numbers printed and accepted or hard drive gets corrupted and data lost). What could be the impact? Rejection, rework or maybe even product recalls.

This would cost you millions of dollars.

Time: Only a few months left for USA - DSCSA and EU – FMD, the level of challenges has escalated considerably with the enormous pressure of timelines when it comes to line-level implementation.

Typically, full line implementation takes at least six months (project start-up, documentation like FS, DS, manufacturing, FAT, SAT and validation), and due to the high volume of business, major solution providers also find it difficult to improve the

delivery timeline.

The India-specific solution The Indian pharma industry’s manufacturing spectrum is very vast, ranging from very small, single-line units supplying to domestic markets, to multiple highly sophisticated high-speed lines exporting to global markets. This demands multiple solutions with differential pricing, which must be fit for the purpose. The right solution for one company can be proven wrong for another.

However, the following can be common factors to help select an effective solution.

Modular: The solution can be implemented in various modules and easily integrated on the packaging lines. Solutions can be designed in such a way that it can also be implemented in phases.

Scalable: If a customer wants a solution to meet the regulations of only a few countries today, later on, the same system must be capable to meet other countries' regulations without major impact on packaging line and the cost.

For example, if the solution is deployed to meet India DGFT regulation, the same solution should work for EU FMD or USA – DSCSA compliance without a major change in hardware and software plus at minimum cost.

MANAGEMENT/SERIALISATION Flexible and adaptable: The solution should be flexible enough to accommodate any type of packaging line and any type of packaging configuration and adaptable to customer-specific product processes (like IPQC etc.), easy integration with line machinery, and work with any leading OEM partners, ERP/MES and IT solution provider and vice versa.

Open end/non-vendor-locking: The solution should work with any line, IT solution provider or printer suppliers of customer’s preferred choice, and it should be easily integrated. Vendor-locking architectures or suppliers are highly dangerous, as they lead to high costs at later stages.

Versatile: The solution should be designed in such a way that it addresses one problem with many approaches. It must address the various types of lines, products, packaging, speed and aggregation patterns. Capability to meet various global serialisation regulation requirements must also be considered.

Reliable: Imagine your business is volume-driven and your packaging lines run 24/7.

If a small problem occurs in the serialisation system, it may result in significant down time and production loss.

Therefore, the selected solution must be highly reliable (as bypass mode is no longer accepted).

Easy to operate: Most of the packaging lines are running with contractual employees who are not high skilled engineers. The system must be easy to operate and ergonomically designed. Otherwise, problems will occur during productivity ramp-up, leading to breakdowns and rework.

Cost-effective: If the system is not cost-effective, it will affect the company’s business model, resulting in higher production costs and thus impacting profitability. Deciding between a system that is

Track and trace is a new technology platform and a big change for production and engineering staff.

Absence of adequate training and continuous support will lead to loss of productivity and more downtime due to rejection and rework 'costly, but reliable' and one that provides good 'value for money' is very critical. When there is a question of compliance and business continuity, the question of pricing is secondary. The first question must be whether the vendors and selected solutions are capable of meeting current and future requirements? Does it deliver the right value to enhance present business? What would be the ROI? Only then, one should think of optimising the solution to make it more cost-effective.

Vendor evaluation Everybody is a genius. But if you judge a fish by its ability to climb a tree, it will live its whole life believing that it is stupid –Albert Einsten.

Product seller or solution provider: There is a clear distinction between a long-term solution partner and a product seller. Global track and trace is a very complex, long term, multifunctional project with limited clarity on what to do and how to do it. The solution provider must have strong and robust internal quality processes, unmatched experience in the field and working with global regulatory authorities to develop an effective solution. One size does not fit all, as this would be a fatal approach for serialisation.

Global track and trace experience: There is also a huge difference between an 'available solution' and the 'we shall develop for you' approach.

Proven solution providers assure you peace of mind by eliminating trial and error, and the success factor is really high. Often, people fail to understand the real cost of trial

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and error on the commercial packaging lines and are more inclined to save on initial capital investment. Has this vendor implemented end-to-end solution? How many partners do they work with? How many total solutions deployed? etc.

Asking for customer references and visiting them to see the production line in operation will give you a fair idea and learning opportunity from that reference.

Local support and adaptability: Track and trace is a new technology platform and a big change for production and engineering staff. Absence of adequate training and continuous support will lead to loss of productivity and more downtime due to rejection and rework. Prompt services by qualified support staff of solution provider is a key factor to ensure smooth running of lines post-implementation. If the solution is not adaptable to one’s production process, not in line with your validation criteria, then it will increase the chances of project delays and revalidation.

Optel Vision was selected by a global MNC in India because it demonstrated its proven global experience, local reach and adaptability to their manual packaging lines, running with multiple configurations. A totally customised approach is inevitable to be successful in this kind of environment rather than offering some stand-alone machines!

Financial capability: This project is long-term in nature, and it may take many years for full deployment. If your vendor is not financially capable, you are taking a great risk when you invest millions of

dollars in this solution.

The first step toward success is taken when you refuse to be a captive of the environment in which you first find yourself - Mark Caine

The best approach to evaluate a vendor in totality Engineering assessment: Let the vendor do the engineering assessment of your production lines and understand your requirements. Then ask him to offer multiple solution scenarios with respect to cost and risk. 50 per cent of the vendors shall be screened during this exercise.

How you can assess the reliability of vendor? The answer is: See yourself, feel yourself and believe yourself.

Facility visit and vendor audit: For the large multi-locations projects, it is essential to visit the vendor’s production facility and meet experts to understand how they work.

Also perform a quality audit of their systems and processes.

Reference check: Visit at least four to five different customers where they implemented their solutions and check the reliability, flexibility, adaptability of the solution.

Techno-commercial evaluation (based on TCO): Since track and trace is a relatively new platform entailing the amalgamation of various technologies, the total landscape is not entirely visible. Often, the evaluation is done comparing existing vision and printing technologies available in the plant, but global track and trace goes far beyond existing technologies!

It is better to learn from someone’s experience than to learn hard way. If the wrong system was selected, then the company needs to 'manage' different ways to run that system.

The other tool available for comprehensive commercial evaluation is the TCO.

The TCO perspective: What we see is often just a fraction of reality TCO comprises initial capital investment (direct and indirect costs), operation costs, service and maintenance costs, as well as hidden costs.

Direct cost: This is often mentioned in the service provider (vendor) quote and includes things like hardware, software, integration, validation, documentation and FAT/SAT. Ideally, the quote must also include new OEM equipment (printers, case packers, print and apply, etc.), print layout software and layout preparation, additional conveyors, mounting, guides, brackets, signal exchange with existing PLC, validation documents and execution assistance, training assistance, shipping costs, etc.

Many times, it has been observed that some vendors keep their initial offer very low and later, during the project execution phase, the customer is forced to pay more (as common level of understanding was deliberately not achieved).

Indirect costs: This is the cost which involves the internal resources of the organisation, like project management, validation execution, IT Integration, training, line modifications/redesig, electrical wiring, network connections etc.

Hidden costs: This includes expenses related to acquisition/purchase, set-up, change management, infrastructure support, electronic security, rejection and rework, product recalls, line breakdown/shutdown, line efficiency drop, etc.

Track and trace is a business decision of a strategic nature.

The project/purchase department must work with the cross-

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MANAGEMENT/SERIALISATION functional team to evaluate TCO rather than focusing only on initial capital investment and maximising discount. If the vendor offers a huge discount, it means either they do not believe in ethical business practices or are cutting corners.

One customer told me, “If the chosen solution saves my four days of production shutdown annually, in spite of the high capital investment, the ROI is achieved in a year.” We all know what does it cost us if a line shuts down, or if there is a high rejection and rework rate.

Pilot deployment: In general, compliance timelines are really short (a few regulations are already in effect and some are on the verge), but if you have sufficient time it is strongly recommended to go for a pilot line with one or two vendors and from there evaluate further which can be your long-term track

38 EXPRESS PHARMA August 1-15, 2016

and trace partner.

Conclusion

TCO (Total cost of ownership)

Global track and trace is highly complex in nature and the success mantra is: Understand what it is, where you are, what you need, involve all necessary functions, evaluate vendors with TCO analysis, build long-term relationship with your solution partner, and take joint responsibility as a team to make this project successful.

The countdown has begun, if you aim for global business, serialisation is a must. The earlier, the better.

Have a bias toward action; let’s see something happen now. You can break that big plan into small steps and take the first step right away - Indira Gandhi Shaunak J Dave can be reached at shaunak.dave@optelvision.com

MANAGEMENT/SERIALISATION NEWS

Recipharm announces global serialisation collaboration Partners with Marchesini, SEA Vision and TraceLink RECIPHARM, THE contract development and manufacturing organisation (CDMO), has formed a global partnership with Marchesini, SEA Vision and TraceLink to introduce new serialisation capabilities. The announcement marks the next step in the global CDMO’s plans to invest €40m over the next three years to ensure state-of-theart solutions for serialisation processes.

The investment will ensure that pharmaceutical companies accessing Recipharm’s manufacturing services will comply with the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation, which makes serialisation of licensed drug products in Europe a legal requirement from early 2019.

After assessing various vendors, Recipharm selected Italian-based

Marchesini and SEA Vision to meet its hardware and software requirements for serialisation at levels one (device level), two (line level) and three (site level). The company has also selected the TraceLink Life Sciences Cloud, the world’s largest pharma track and trace network, which will act as a level 4 central repository to meet the CDMO’s enterprise serialisation management and global tracking needs.

The complete serialisation solution will be implemented in 15 of Recipharm’s European locations and on more than 70 production lines. The company anticipates that a pilot showcase line will be operational from July 2016 to allow customers to view and trial Recipharm’s standard solution for serialisation and aggregation.

EP News Bureau-Mumbai

Aesica Pharmaceuticals meets serialisation challenges The company is currently applying its novel solution to enable customers to meet the specific serialisation demands of China and South Korea AESICA PHARMACEUTICALS, the global pharmaceutical contract development and manufacturing organisation, which provides pharma customers with flexible, efficient and reliable technological resource that enables full and fast compliance with all the varying serialisation regulations across the globe, is currently applying its novel solution to enable customers to meet the specific serialisation demands of China and South Korea The modular technology and system has the distinct benefit of being the same for all countries, whilst enabling pharma customers to meet specific serialisation regulations that vary markedly across different nation states and regions. The highly flexible

solution has the capability to maintain data in multiple formats bespoke to each country’s individual regulatory rules. Consequently, customers are provided with a resource that ensures all serialisation requirements can be managed locally.

The implementation of serialisation services for the Chinese market, one of the world’s most complex for serialisation regulations, took under six months for Aesica to complete. The company’s serialisation module is also already on hand for customers that need to satisfy the demands of Brazil, the especially complex serialisation regulations of Turkey and Argentina and those faced

by EU countries.

EP News Bureau-Mumbai

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RESEARCH

ZIAKdistant A VAdream?

CCINE The development of the Zika virus vaccine has been hindered by its complexity and doubts over its marketability

By Sachin Jagdale

T

he outbreak of Zika in Brazil has thrown up yet another challenge for the global healthcare fraternities, who were already bogged down with the Ebola epidemic, which mainly focused in the African region.

Moreover, Zika could prove to be a bigger health threat than Ebola as it is comparatively more prevalent in various other regions of the world. According to estimates by the Centre for Disease Control and Prevention (CDC), Zika virus transmission has been noticed in and around 50 countries globally. With no specific medicines available for treatment there was an urgent need to develop vaccines for the virus.

It is a race against time as the virus has slowly but steadily spread its tentacles. Though scientists have come up with various possibilities to develop a vaccine, it is still an uphill task.

Less familiarity and increased complexity Zika symptoms are generally mild but it can cause devastating effects such as affecting pregnant women and causing Microcephaly, a severe brain malformation in the foetus. However, its quick transmission in various parts of the world has prompted the World Health Organisation (WHO) to declare Zika as a global public health emergency.

As mentioned earlier, developing a vaccine to tackle the growing incidence of the disease is of utmost importance. However, lack of enough information about the

40 EXPRESS PHARMA August 1-15, 2016

Zika Virus has not been well studied so far in comparison to its better known cousins due to the previously low impact of the virus. Very little is known about Zika virus replicates, its pathogenesis or how the immune system protects against its infection Dr Manju Phadke Associate Prof, Dept of Microbiology, SIES College of Arts, Science and Commerce

disease is proving to be a big hurdle.

Dr Robin Mukhopadhyaya, Formerly, Prof. ACTREC, Tata Memorial Centre explains, “Zika virus is similar to the dengue virus and it belongs to the virus family Flaviviridae and the genus Flavivirus. Any laboratory having expertise in culturing and maintaining any other Flavivirus can grow this virus.

Quite a few laboratories are well accomplished in that including the National Institute of Virology (NIV), Pune the nodal surveillance centre. Once a strain of virus is available, an inactivated virus format can theoretically serve as the starting material to develop a prophylactic vaccine candidate. Some flaviviruses may have different subtypes, as four subtypes (referred to as serotypes) are there for dengue and hence an effective dengue vaccine should be able to neutralise all subtypes for a given population at risk.”

However, there are certain challenges. Mukhopadhyaya highlights, “There is no peer reviewed document yet to prove whether there are different Zika serotypes or if the virus mutates.

However, genome sequence of strains obtained in different countries, e.g., in Malaysia and Cambodia, have been shown to diverge, though how much of divergence have bearing on developing vaccine candidates has not been studied.”

Dr K Anand Kumar, Managing Director, Indian Immunologicals, also expresses similar views. He further says that the first hurdle would be to identify

a suitable strain of the virus, which could then be developed into a vaccine. It is imperative that the vaccine provides cross protection against majority of prevalent strains of the virus, or else the use of such a vaccine may be restricted. It may lose its utility with the emergence of newer strains.

He also points out that there are no suitable animal models or correlates of protection available as of now to ensure that the vaccine would have limited risk of failure in clinical trials.

“The major challenge would be to ensure the safety and efficacy of the vaccine in various age groups of the human population.

Both these aspects will require large, time consuming and very well planned clinical trials in areas where the disease is prevalent considering the same regions would probably be also endemic to dengue and chikungunya,” insists Anand Kumar.

Dr Manju Phadke, Associate Prof Dept of Microbiology, SIES College of Arts, Science and Commerce, also points out, “Zika Virus has not been well studied so far in comparison to its better known cousins due to the previously low impact of the virus. Very little is known about Zika virus replicates, its pathogenesis or how the immune system protects against its infection. Structurally a complex virus, it also has a complex mechanism of protein synthesis and replication. The site of protein synthesis being the cytoplasm of the infected cell and the site of replication being the nucleus of the infected cell.”

Low commercial viability There is a commercial angle as well to this debate. Many big pharma companies have taken a cautious approach towards Zika outbreak mainly due to doubts regarding marketability of Zika vaccine. Industry experts believe that there is a possibility that areas affected by Zika virus may develop natural immunity against the disease over the next few years. A rise in the immunity level will obviously block its spread as well. Hence, there will be a less urgent need of the vaccine due to mild impact of the virus coupled with its sluggish

spread. Pharma companies are in a dilemma whether to tap this segment as there is decline in the number of cases in the virus dominated areas such as Brazil, and Colombia.

Lack of prior research has also prevented pharma companies from trying their luck on the Zika vaccine. But, companies like Sanofi has taken a keen interest to develop the vaccine, and have a valid reason to do so.

This is because dengue and the Zika virus belong to the same family and Sanofi has two decades of experience in dengue vaccine development.

According to Mukhopadhyaya, some biopharma companies in the US and/or Europe should have already taken initiatives to develop the vaccine as tropical countries are infested with the Aedes mosquitoes, which are again large markets for them. Even, Pasteur Institute in France has long studied this virus.

Highlighting a few more key global developments, Dr Sunit K Singh, Associate Professor (Molecular Immunology) and Head-Molecular Biology Unit, Institute of Medical Sciences, Banaras Hindu University says, “Efforts are on to design and test a vaccine against Zika but it is a long process which needs years to complete. Scientists believe that it will take at least three to four years to come out with something concrete. National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, plans to begin phaseI trial of a DNA vaccine against Zika Virus by September 2016.

Inovio Pharmaceuticals and GeneOne Life Science have received approvals to initiate phase I clinical trials to evaluate Zika DNA vaccine (GLS-5700).

In pre-clinical testing, these companies have reported that the vaccine induced robust antibody and T cell responses in small and large animal models.”

Singh adds, “Recently, Grant et al published a manuscript in Cell Host and Microbe May 2016 issue, where it has been demonstrated that viral protein known as NS5 is a promising target for vaccines against Zika. They reported that NS5 protein of the Zika virus prevents Zika

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The first hurdle would be to identify a suitable strain of the virus, which could then be developed into a vaccine. It is imperative that the vaccine should provide cross protection against majority of prevalent strains of the virus Dr K Anand Kumar Managing Director, Indian Immunologicals

“Efforts are on to design and test a vaccine against Zika but it is a long process which needs years to complete.

Scientists believe that it will take at least three to four years to come out with something concrete Dr Sunit K Singh Associate Professor (Molecular Immunology) and Head-Molecular Biology Unit, Institute of Medical Sciences, BHU

virus-infected human cells from signalling immune system cells to make interferon, a powerful antiviral protein. Scientists believe that it may be possible to design a vaccine against Zika virus by using a live, weakened form of the virus made by altering the NS5 protein.”

Coincidentally, though India hasn’t reported any case of Zika virus yet, the country is one of the key contributors in the global arena to help develop a vaccine for the zika virus. As mentioned in Wikipedia, Hyderabad-based Bharat Biotech had reported in early February 2016 that it was working on vaccines for the Zika virus using two approaches: ‘recombinant’, involving genetic engineering, and ‘inactivated’, where the virus is incapable of reproducing itself but can still trigger an immune response with animal trials of the inactivated version.

advisory, screening, laboratory diagnosis at certified ICMR laboratories etc. However, Anand Kumar also rings the warning bell and says, “Considering the diversity and socio politico –economic structure of our country, I believe it will be a Herculean task to contain the disease if it spreads across the country.”

He adds, “I feel that as Indian vaccine manufacturers have a lot of expertise to develop such vaccines, it will be vital for the Ministry of Science & Technology and Ministry of Health and Family Welfare, Government of India, to engage with major players and provide suitable vaccine strain of Zika in coordination with the WHO as well as offer support for clinical development of the vaccine. This will also facilitate the generation of a suitable vaccine with broader cross protection.”

Susceptibility in Indian population

Long road ahead

India, being a tropical country, is a breeding ground for the Aedes aegypti mosquitoes. A vector for dengue and chikungunya, it is a vector for the Zika virus too.

Hence, the chances of Zika virus affecting the Indian population is high.

“With modern day intercontinental travel ease, emergence of Zika virus in India is fairly possible, though the time of emergence cannot be predicted.

Detection is a standard procedure. NIV, ICMR regional virology centres as well as other few research institute labs with research expertise in dengue virus/JE virus can be geared for quick detection. Usually, the viral genome (RNA) in the blood (serum) samples of suspected individuals is detected by RT-PCR method, which is a common technique these days. However, appearance of early antibody/ immunoglobulin (IgM) in serum or presence of viral genome in urine have also been tried,” says Mukhopadhyaya.

Seeing that India not immune to the Zika virus, Government of India took immediate steps and deployed remedial measures as soon as WHO declared it as a public health emergency. This included travel

As discussed earlier, lack of prior research and its commercial viability are the two major roadblocks. Lack of prior research and documentation will only further delay the process. The lack of market potential will prevent pharma companies from investing in the development of this vaccine. So, the chance of a vaccine for the Zika virus hitting the shelves in the near future is rare.

From an India perspective, the good thing is that though we are still unaffected by the Zika virus, we have already started taking preventive measures against it. As Anand Kumar mentions, “It is high time that the scientific fraternity from both academia and industry come together and start planning for future exigencies based on the current outbreak rather than focusing on just immediate needs. We need to have more discussions on similar vector borne or other zoonotic diseases, which can have major repercussions in the future due to climate change and transboundary migration of humans and animals. It will ensure vaccine preparedness in case of emergence of new diseases.” sachin.jagdale@expressindia.com

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RESEARCH UPDATES

Disturbances in blood cell gene transcription may lead to leukemia Researchers were able to show that DNA damage associated with leukemia occurs in regions in which the DNA is being transcribed particularly actively RESEARCHERS HAVE succeeded in shedding light on the pathogenesis of DNA breakpoints that are associated with leukemia. A mechanism discovered in a recent study can explain up to 90 per cent of DNA damages present in the most common type of leukemia in children. The study was carried out by the University of Eastern Finland and the University of Tampere, and the findings were published in eLife.

Leukemia is the most common form of cancer in children.

Thanks to several genome-wide studies carried out over the past years, our understanding of the biology of leukemia has increased rapidly. The fact that gene deletions in leukemic blood cells are often associated with

specific genes or DNA regions has caught the eye of researchers, but the underlying reason has remained in the dark.

Led by Academy Research Fellow Merja Heinäniemi at the University of Eastern Finland and involving the research group of Chief of Department, Docent Olli Lohi at the University of Tampere, a new study finally sheds light on the pathogenesis of DNA lesions present in leukemia. For the first time, researchers were able to show that DNA damage associated with leukemia occurs in regions in which the DNA is being transcribed particularly actively. The explanatory power of the observed mechanism is different in different types of leukemia; however, in the most common type of

leukemia in children, the mechanism explains up to 90 per cent of damages occurring in the gene regions. In addition, the study identified a new, high-risk subtype of leukemia, which is characterised by abnormal expression of enzymes that cause DNA damage.

“When we studied the char-

acteristics of a signal that describes gene transcription, we discovered that in regions that are susceptible to damage, gene transcription slows down and temporarily exposes the DNA to enzymes that cause DNA damage,” Heinäniemi says.

“The transcriptional machineries that are going in different directions within gene regions collide, possibly causing irreversible damage. Luckily, most of these ‘accidents’ are just close calls and they only become dangerous in children whose blood cell progenitors have other predisposing gene damages,” Lohi explains.

A similar mechanism has previously been discovered in lymphomas, which are cancers of the lymphatic tissue. At the

moment, mechanisms relating to the pathogenesis and repair of DNA damage are a hot topic of research. This study increases our understanding of the diversity of gene damage and leukemia, as well as of mechanisms by which cancer can become resistant to treatment.

The mechanism was discovered by using several deep sequencing methods such as GRO sequencing, which was used to analyse the DNA regions actively read by RNA polymerases.

The measurements were carried out at the University of Eastern Finland from samples collected at the Tampere Center for Child Health Research at the University of Tampere.

EP News Bureau-Mumbai

FDA panel backs Valeant psoriasis drug with risk programme Valeant has a risk management proposal that includes participation in a registry and enhanced communication but no boxed warning VALEANT Pharmaceuticals International's experimental drug to treat the skin disorder psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the US Food and Drug Administration concluded. In clinical trials of the drug, brodalumab, there were six suicides across all programmes, four in psoriasis studies, one in a rheumatoid arthritis study and one in a psoriatic arthritis study. Even so, the committee voted 18-0 that the drug should be ap-

42 EXPRESS PHARMA August 1-15, 2016

proved, saying the benefit outweighed the potential risk.

Of those, 14 voted that the drug should only be prescribed alongside a strong risk management programme that goes beyond simply including the information in the label. Such programmes can include medication guides and communications plans for healthcare providers. Panelists said there was a need for new drugs for psoriasis and they would like to have brodalumab available as an option. They offered various suggestions about how to mit-

igate the suicide risk, including a boxed warning and a patient registry to collect patient data and more clearly assess suicide risk. Some thought the registry should be mandatory and others thought it should be voluntary. Some thought any registry would create unnecessary barriers to accessing the drug and may not reflect a true estimate of the suicide risk.

Valeant itself has a risk management proposal that includes participation in a registry and enhanced communi-

cation but no boxed warning.

Brodalumab blocks a cell receptor known as interleukin17 to tamp down inflammation. Several other IL-17 inhibitors are already on the market, including Cosentyx from Novartis AGand Taltz from Eli Lilly & Co. The drug would also compete with Amgen’s Enbrel, Johnson & Johnson’s Remicade and AbbVie’s Humira. About 7.5 million people in the US suffer from psoriasis, according to the American Academy of Dermatology. The disorder, characterised by raised, scaly skin

patches, can be associated with other conditions, including diabetes and heart disease. Brodalumab was initially developed by AstraZeneca and Amgen in May, 2015, Amgen withdrew from the partnership because of the suicides. AstraZeneca subsequently licensed global rights to the drug to Valeant, whose fortunes have plummeted over the past year amid criticism of its high drug prices and cloudy relationship with a specialty pharmacy.

Reuters

RESEARCH

Stem cells improve blood vessel function following spinal cord injury The current study focused on suppressing damaging inflammation and improving blood vessel function, which may reduce the extent of injury A NEW study published in Stem Cells Translational Medicine (SCTM) by Badneret al shows how a minimally invasive stem cell treatment in rats can reduce secondary damage in traumatic spinal cord injury (SCI). While similar studies have also demonstrated the promise of stem cells as a therapy for SCI, what makes this one different is the type of stem cell used. For the first time, researchers evaluated whether a brain-derived stromal cell would be better suited to target the acute phase of SCI than cells derived from other tissue sources. The answer was yes.

SCI is a life-threatening condition with limited treatment options. It occurs in two phases.

The primary phase takes place when the initial trauma causes mechanical injury to the spinal cord. The secondary injury comes in the hours after. As the body attempts to deal with what has happened, it releases a surge of chemicals causing inflamma-

tion, decreased spinal cord blood flow and cell death – which further exacerbates the injury. As the body cannot readily replace dying cells after spinal cord injury, neurological function becomes permanently impaired, resulting in in severe movement and sensory disabilities.

While studies in animals have shown that the transplantation of stem cells might aid

spinal cord repair by, among other things, replacing dead neural cells, the current study focused on suppressing damaging inflammation and improving blood vessel function, which may reduce the extent of injury. Central nervous system (CNS) pericytes (specialised cells surrounding the capillaries) have recently gained significant attention within the scientific commu-

nity. In addition to being recognised as major players in neural tissue trauma, pericytes share a common origin and, potentially, a common function with traditionally defined mesenchymal stromal/stem cells (MSCs). Although these cells have been previously studied in the lab, their therapeutic application (in vivo) has not been evaluated.

“Our study demonstrates that these cells not only display a MSC phenotype in a dish, but also have similar immunomodulatory effects in animals after spinal cord injury that are more potent than those of non-central nervous system tissue-derived cells. Therefore, these cells are of interest for therapeutic use in acute spinal cord injury,” said lead investigator Michael Fehlings.

The Fehlings research team, based at the Krembil Research Institute in Toronto Western Hospital and the University at Toronto, conducted their study

by injecting human CNS-derived stromal cells into rats with SCI, and compared the results to a control group treated with MSCs. The cells protected blood vessels in the injured area, among other positive outcomes.

“These early effects further translated into enhanced functional recovery and tissue sparing 10 weeks after SCI,” Dr Fehlings added. “This work demonstrates a new therapeutic approach.”

“The ideal source of cells for treating spinal cord injury has been a controversial and open question,” said Anthony Atala, Editor-in-Chief, SCTM and director of the Wake Forest Institute for Regenerative Medicine.

“These results, showing the positive effects of central nervous system pericytes, not previously investigated for spinal cord injury, are intriguing and suggest a potential new therapeutic use.”

EP News Bureau-Mumbai

FDA panel supports Novartis version of Amgen arthritis drug The drug, GP2015, if approved by the FDA, would be approved for all sought conditions NOVARTIS’ CHEAPER version of Amgen’s arthritis drug Enbrel is highly similar in potency and safety to the original and should be approved, an advisory panel to the US Food and Drug Administration concluded.

The panel voted 20-0 that there is no clinically meaningful difference between Novartis’ drug, a biologic made of living cells, and Enbrel. Copies of biologics are called biosimilars, not generics, because they are more difficult to imitate with precision. Enbrel has been approved to treat multiple conditions, in-

cluding rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Novartis tested the drug, GP2015, in patients with plaque psoriasis but if approved by the FDA, it would be approved for all sought conditions.

The FDA is not obliged to follow the advice of its advisory panels but typically does so. Novartis, through its Sandoz division, tested the drug, GP2015, in patients with plaque psoriasis but if approved it would be approved for all conditions. The

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panel discussed the merits of extrapolating data from one condition to the others and though some members had reservations, was reassured by the fact that the drug works the same way in all the approved conditions. The panel unanimously recommended approval for Amgen’s biosimilar version of AbbVie’s arthritis drug Humira. Panelists had reservations about extrapolating results from trials Amgen's drug in rheumatoid arthritis and psoriasis to Crohn's disease and ulcerative colitis, saying it is unclear how

the drug works in those conditions.

Unlike Humira, Enbrel is not approved to treat irritable bowel disorders. Some patient advocates who addressed the meeting said the committee should in future be allowed to vote on different indications individually rather than Enbrel was approved in 1998 and generated more than $5 billion in US sales last year. Like Humira it works by blocking a protein known as tumor necrosis factor, or TNF, that plays a role in inflammatory conditions. Humira generated

US sales last year of more than $8 billion.

AbbVie is fighting a legal battle to keep Amgen’s biosimilar from the market. Amgen in turn is fighting to keep Novartis' biosimilar from the market. Patient groups urged the FDA to finalise rules for how biosimilars should be named and labelled and for rules to be put in place to prevent insurance companies from switching patients from a drug that they know works to one they don’t know.

Reuters

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RESEARCH

Antipsychotic drug relieves nausea during cancer chemotherapy The test was done on people who were receiving cisplatin or a combination of cyclophosphamide and anthracycline for their tumours ADDING THE cheap antipsychotic drug olanzapine to conventional anti-vomiting medicine can help prevent nausea in cancer patients, according to a new test of 380 volunteers.

During the first 24 hours after chemotherapy, 74 per cent of patients receiving the drug along with their chemotherapy reported no nausea. That compares to 45 among those getting placebo. The benefits continued for five days as the drug therapy continued. “I was overjoyed that the results were statistically significant,” because it was the first study to look at nausea alone, said Chief Author Dr Rudolph Navari, Indiana University School of Medicine in South Bend.

Existing drugs are good at preventing vomiting but “we really don’t have any effective anti-nausea treatment,” he said. “That can be a big problem in terms of going to work, taking care of the kids and quality of life.” “It adds to the number of weapons and options that might be considered if other strategies are not effective,” said Dr John Erban, clinical director of the Tufts Medical Center Cancer Center in Boston, who was not involved in the study.

But a key side effect of olanzapine, extreme fatigue in some patients, could pose a problem, he said. The test was done on people who were receiving cisplatin or a combination of cyclophosphamide and anthracycline for their tumours. Both regimens are known for producing nausea and vomiting. Breast cancer was the diagnosis in 64 per cent of the patients, lung cancer in 13 per cent and the rest were being treated for other types of tumors, according to the report published in the New England Journal of Medicine. By the end of the five-day treat-

44 EXPRESS PHARMA August 1-15, 2016

Brainstorm’s cell therapy succeeds in ALS mid-stage study BRAINSTORM CELL Therapeutics said its experimental cell therapy was safe and well tolerated in patients with amyotrophic lateral sclerosis (ALS), a progressive neurological disorder, in a mid-stage study.

There were no serious side effects, although the drug did produce severe sedation in 5 per cent of recipients around day two. That subsided over time, the researchers write, “suggesting that the patients adapted to the sedative effect” ment period, 37 of those taking olanzapine had experienced no nausea at all, compared to 22 per cent of placebo recipients.

When the team looked at clinically significant nausea - a score of three or more on a zeroto 10 scale – 67 per cent of the olanzapine recipients were free of it during the five-day period versus 49 per cent among those getting standard therapy.

Olanzapine is available in generic form. The five days of treatment cost about $2. The patients were only followed for one treatment cycle. Nonetheless, Navari said, it's likely that

the drug's anti-nausea effect would persist through subsequent cycles. When used as an antipsychotic, "it’s been given for three, six, nine months and its effectiveness did not wear off," he said.

There were no serious side effects, although the drug did produce severe sedation in 5 per cent of recipients around day two. That subsided over time, the researchers write, “suggesting that the patients adapted to the sedative effect.”

"There's really no drawback to using the drug because it doesn't cost anything and you only

give it a couple of days,” Navari said. “We saw evidence of mild sedation in 20 per cent, but there really weren’t any side effects. Those patients continued on the drug and the sedation resolved by day three and four.” But “the fatigue issue can be a problem,” Erban said.

“A lot of patients are trying to balance their work and their home life so they will want to find a formula where they get their treatment and be as functional as possible,” he said. No patients discontinued treatment because of fatigue. “The principal concern with olanzapine treatment is weight gain and other metabolic consequences. However, these usually occur with more extended exposure, which is not applicable to this situation,” said Dr David Greenblatt, a pharmacology researcher at Tufts.

“Since there was no other antipsychotic agent comparatively evaluated in the study, it can't be concluded that olanzapine is unique,” he said. “Another antipsychotic might well have similar properties.”

Reuters

ALS, or Lou Gehrig’s disease, is an invariably fatal neurological disorder that affects the nerve cells responsible for controlling voluntary muscles.

The drug, NurOwn, also showed a clinically meaningful benefit in terms of disease progression compared with a placebo, the drug developer said. About 6,000 people in the US are diagnosed with ALS every year and as many as 20,000 Americans have the disease at any given time, according to the ALS Association.

Reuters

RESEARCH

Resverlogix announces dosing of first two patients in expanded renal and orphan programmes The commencement of this phase 1 pharmacokinentic (PK) trial in patients with severe renal impairment is the first in a series of planned clinical trials designed with value creation in mind RESVERLOGIX CORP has announced that dosing has commenced in a phase 1 PK study with lead drug candidate apabetalone (RVX-208) in patients with severe renal impairment.

While the company's phase 3 BETonMACE trial, designed for high-risk cardiovascular disease patients with type II diabetes and low HDL is enrolling as planned, this phase 1 trial has been initiated and designed in accordance with the company's strategy to expand into new indications such as renal (chronic kidney disease) and orphan diseases with our lead candidate, apabetalone. This trial has the potential to create increased value for apabetalone in new high-risk patient segments which have shorter develop-

ment paths to product registration and market adoption.

The primary objective of the phase 1 study, based in New Zealand, is to determine if apabetalone treated patients with severe renal impairment have the same favourable PK traits as has been witnessed in previous apabetalone trials. Results are expected in the second half of 2016, and if successful, will allow for more advanced renal impairment and dialysis trials to proceed. The study will also explore acute changes in biomarkers relevant to Bromodomain and Extra-Terminal (BET) inhibition in subjects with severe renal impairment.

Two cohorts, each consisting of eight subjects, will be evaluated in the study. Cohort one will include subjects with end-stage

renal disease (ESRD) not on dialysis, with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m 2 while cohort

two will include healthy individuals whose age, weight and gender will be matched to the renal impaired subjects. All subjects will receive a single oral admin-

istration of 100mg of apabetalone.

Dr Kamyar Kalantar-Zadeh, Chairman, Renal Clinical Advisory Board, and member of the BETonMACE Clinical Steering Committee stated, "The results from this study will further assist the company in advancing planned phase 2 trials into expanded renal indications. Additionally, potential effects on novel biomarkers and pathways affected by select BET inhibition in patients with severe renal impairment may be elucidated and provide insight for the pre-specified subgroup in Resverlogix's phase 3 clinical trial BETonMACE, where is it anticipated that approximately 15 per cent of subjects will have moderate renal impairment."

EP News Bureau-Mumbai

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August 1-15, 2016

PHARMA ALLY VENDOR NEWS

AVTnames Matt Bennett President of the Americas Bennett will be responsible for managing and executing all sales, marketing and customer support activities for AVT

A

dvanced Vision Technology (AVT), a leader in print automatic inspection, process control, quality assurance and colour control for the packaging, label and commercial print markets, has named Matt Bennett as President of the Americas.

In his new role, Bennett will be responsible for managing and executing all sales, marketing and customer support activities for AVT in the Americas. As President of the Americas, Matt will also join AVT’s

corporate management group and will report directly to CEO, Jaron Lotan.

Prior to joining AVT, Matt served as the Sales Director of Packaging, North America for HP. He brings with him many years of experience and an outstanding performance record, especially in leading HP’s entry into the flexible packaging and folding carton markets. Prior to that, he spent 17 years with Heidelberg, where he climbed the ranks from salesman to regional manager and, ulti-

mately, vice president.

Bennett said, “I'm excited with the opportunity to oversee North American activities for the worldwide market leader in inspection, quality and colour management systems. More and more brands and packaging converters are demanding the highest quality control and process requirements that only AVT solutions can deliver."

Jaron Lotan, Chief Executive Officer, AVT said, “We are happy to welcome Matt to

Global courier industry worth $66 bn in 2021: Ngenko Investments

AVT in this important position. Bennett brings with him many years of experience and successful leadership, and close familiarity with AVT’s customer base and business model. I am confident that under his stewardship, AVT will continue to grow and succeed in the Americas by providing excellent value to our customers in the form of unparalleled inspection and quality control solutions.”

EP News Bureau-Mumbai

Thermo Scientific Vanquish Flex Binary UHPLC launched

Growing usage of advanced facilities such as real-time monitoring, temperature-controlled shipments for segments like pharma and healthcare will drive growth

The system boosts high-speed applications and provides exceptional LC and LC-MS performance

GROWING DEMAND for urgent and time-bound delivery by major customers segments from the pharmaceuticals, banking sector, garments and FMCG, IT components and auto components form a considerable share of the potential for growth of the courier industry. The global courier industry is anticipated to reach $ 65.88 billion by 2021, according to a new report by Ngenko Investments. Reportedly, growing integration in the transport chain with an enhanced level of tracking and tuning facilities available for shipment deliveries across domestic and international borders has poised the sector to witness steady growth in the near future.

Furthermore, technological developments that include introduction and commercialisa-

RESEARCHERS LOOKING for fast and consistent results can now benefit from the new ultra high-performance liquid chromatography (UHPLC) system from Thermo Fisher Scientific to boost their LC and LC-MS performance.

As the latest addition to the Thermo Scientific Vanquish UHPLC platform, the new Thermo Scientific Vanquish Flex Binary UHPLC system adds a binary solvent delivery option in the 1000 bar (15,000 psi) performance range. The system is built for high-speed, fast gradient applications and the Vanquish platform’s inherent outstanding retention time reproducibility. The Vanquish Flex Binary UHPLC system is the solution for laboratories performing qualitative and quan-

46 EXPRESS PHARMA August 1-15, 2016

tion of smart logistics such as RFID enabled inventory management, and automated robotic warehousing that enable current day market participants to provide greater reach, and more flexible services are features expected to drive demand. Growing usage of advanced facilities such as realtime monitoring, temperaturecontrolled shipments for specific high-value segments such as pharma and healthcare is also a factor expected to drive growth.

The pharma sector forms an important demand share that amounts to a global revenue stream of an estimated $3.55 billion in 2010. This has witnessed considerable demand over the latter half of the past decade primarily due to the advanced tracking, real

time monitoring and cold chain delivery capabilities that have been made available by the courier industry. Key challenges faced by the pharma logistics such as supply chain visibility, IT integration and dynamic containment environment maintenance are the major issues that key industry participants have focused on resolving. The big four of the courier industry viz.; DHL, FedEx, UPS, TNT, are all expected to further develop and improve logistics services that they offer to the pharma and health sector.

With an estimated growth potential amounting to a CAGR of 3.3 per cent, the segment catering to the pharma industry may very well be worth $4.95 billion by 2021.

EP News Bureau-Mumbai

titative LC or LC-MS analysis that need to increase sample throughput. Ease-of-use and innovative technologies that are robust by design are making UHPLC widely accessible and enable easy and effective method transfer from established systems and applications.

The Vanquish Flex Binary System features a binary high-pressure gradient pump with 2 x 3 solvent channels and low gradient delay volume capable of delivering high flow rates of up to 8 mL/min. The entire system provides biocompatible flow path, SmartInject using intelligent sample pre-compression, selectable thermostat modes and a unique range of detection capabilities.

EP News Bureau-Mumbai

PRODUCT

Dock levellers by Gandhi Automations GANDHI AUTOMATIONS is India’s number one entrance automation and loading bay equipment company and is ISO 9001: 2008 certified.

Since its inception in 1996, the company has manufactured, imported, distributed and installed products that are problem free and easy to operate.

The company offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses.

Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only ‘a bridge for connecting a vehicle’, but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimise the energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.

Efficient loading and unloading the goods The importance of efficient loading of goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently lesser qualified manpower is being utilised which leads to damage in the goods.

The cost of loading and unloading of goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into the process. Gandhi Automations has always designed so-

lutions based on such scientific approach and feedback from clients. The dock levellers offered by the company ensure loading and unloading with lesser effort and minimal cost.

It is possible to load and unload the products in a safe way and in the process obtain remarkable energy savings.

The loading bay remains with the dock leveller in rest position and the sectional overhead door closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers.

The sectional overhead

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door is then opened only when the vehicle is positioned, brakes applied and engines shut off .This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveller connects to the truck bed for loading / unloading to take place.

At the end of the loading/unloading, the dock leveller is put in the rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of

the process. Following are the two types of dock levellers. a) Radius lip dock levellers Radius lip dock levellers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc.

The self-cleaning lip hinging system does not retain rubbish with automatic end-ofrun, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349. b) Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting

vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc.

These types can be supplied with a lip extending up to 1 m.

Gandhi Automations’ dock levellers are equipped with the most secure safety devices and accessories.

Contact details: Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email : sales@geapl.co.in http://www.geapl.co.in/ dock-levelers.html

EXPRESS PHARMA

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August 1-15, 2016

PHARMA LIFE APPOINTMENT

Madan Mohan Reddy appointed as Chairman of Pharmexcil India He is also the Vice Chairman, Pharmexcil since the last two years facilitate the organisation’s application for grant funding

M

adan Mohan Reddy has been appointed as the Chairman of Pharmaceuticals Export Promotion Council of India (Pharmexcil) during the re-

cently held 65th meeting of Committee of Administration (CoA) in Hyderabad.

He is also the Director on Board and Whole time Director, Aurobindo Pharma, Hyderabad and the Vice Chairman, Pharmexcil since the last two years.

Reddy holds a Master's Degree in Organic Chemistry and held top managerial positions in leading pharma companies. He commands high expertise and knowledge in the pharma industry.

Prior to joining the company, he was the Managing Director of Srichakra Remedies.

EP News Bureau-Mumbai

Cambridge Univ appoints Hilleman Labs’Dr Ankur Mutreja He was appointed at the University of Cambridge under the DBT Cambridge Lectureship programme HILLEMAN Laboratories has announced Dr Ankur Mutreja’s appointment at the University of Cambridge under the DBT Cambridge Lectureship programme. In partnership with the Government of India’s (GoI’s) Department of Biotechnology (DBT), the University invited applications for five fixed-term, research-oriented University Lectureships to strengthen the University’s strategic relationship with Indian research institutions and enhance academic, research and translational capacities of India and the UK. Mutreja, who has been with Hilleman Laboratories, leading the company’s ETEC vaccine project is elated on being selected for this highly coveted role. Expressing his

Dr Ankur Mutreja

views, Mutreja, Project Lead Hilleman Laboratories said, “I am humbled to receive this honour and grateful to the University of Cambridge and the Department of Biotechnology, GoI for considering me for this prestigious posi-

tion. I would also like to express my gratitude to Hilleman Laboratories for providing me a stimulating and highly motivating environment to enhance my knowledge and expertise through advanced research. I look forward to my continued association with the organisation.”

Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories said, “We are proud of Mutreja’s accomplishment and extend our support through his five-year stint at the University of Cambridge.”

Highlighting this as a significant opportunity for Hilleman Laboratories, Gill added, “This presents a unique engagement platform wherein we aim to foster strategic alliances across the UK and Europe.”

EP News Bureau-Mumbai

INITIATIVE

Hetero Healthcare organises Hepatitis awareness programme Conducts Hepathon-Walk for Liver' in Mumbai HETERO HEALTHCARE recently organised the first edition of ‘Hepathon – Walk for Liver’ in Mumbai. It aimed to raise public awareness on Hepatitis with a focus on prevention, diagnosis and effective ways to manage the disease using latest treatment options.

A large number of doctors, corporate employees, students and local citizens from Mumbai participated in this awareness campaign, and walked a distance of three kilometres in Borivali, Mumbai spreading messages and encouraging people to be a part of this Hepatitis

48 EXPRESS PHARMA August 1-15, 2016

awareness programme.

On this occasion, Dr Deepak Amarapurkar, Liver Specialist, Bombay Hospital said, “It is really a fascinating experience being a part of the Hepathon - Hepatitis awareness initiative with my fellow doctors and other members of the society. People should take all preventive and screening measures proactively to avoid the disease. New drugs in the segment of Hepatitis treatment have shown to be more effective and are available at significantly lesser price in India than the western world.”

Parimal Hiradhar, Executive

tis awareness initiative, ‘Hepathon: Walk for Liver.’

Through this initiative, we aim to create better awareness among general public on Hepatitis.”

To mark the World Hepatitis Day – July 28, the company also conducted extensive free screening camps for Hepatitis B & C virus in association with clinicians across Maharashtra, Haryana, Punjab, Uttar Pradesh, Manipur, Tamil Nadu, Andhra Pradesh and Karnataka.

Director, Hetero Healthcare said, “At Hetero Healthcare, we

feel that it is our social responsibility to organise this Hepati-

EP News Bureau-Mumbai

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