Express Pharma June16-30, 2018

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CONTENTS MARKET

Vol.13 No.16 June 16-30, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli,

The draft guideline of UCPMP restricts pharma companies from a lot of traditional marketing practices, however, it opens new doors of opportunity to leverage digital platform | P18

Lakshmipriya Nair, Sanjiv Das, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble

P10: INTERVIEW

MANAGEMENT

RESEARCH

Alexey Petrovich Savelchev Ministry of Industry and Trade of the Republic of Tatarstan

Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer

23 27

DRIVING CHANGE AT NOVO NORDISK SELLING IN THE NEW AGE

Gauri Deorukhkar Senior Artist

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Rakesh Sharma Digital Team

CHINA APPROVES FIRST HOME MADE ANTI-HIV DRUG

30

NOVARTIS WINS KEY EUROPEAN PANEL’S THUMBS-UP FOR MIGRAINE DRUG

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ANALYTICA ANACON INDIA AND INDIA LAB EXPO TO BE HELD IN HYDERABAD

Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer) Photo Editor

PHARMA LIFE

PHARMA ALLY

Sandeep Patil MARKETING Regional Heads

Automation solutions for PHARMA industry

Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager

P31: INTERVIEW Manoj Mishra AVP - Sales and Marketing, Uniworth Enterprise

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CALIBER OPENS OFFICE CAMPUS AT SANATHNAGAR INDUSTRIAL ESTATE

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DR CYRUS POONAWALLA CONFERRED WITH ‘DOCTOR OF SCIENCE HON.’

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SUN PHARMA RECEIVES CSR AWARD

www.br-automation.com

BR Tipnis Manager

Express Pharma®

Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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EDITOR’S NOTE

Halol haze lifts, finally

N

ews that Sun Pharma’s Halol facility was finally cleared by the US FDA bought cheer to India Pharma Inc. The warning letter (WL) of December 2015 had been a major bugbear for the company pulling down its share prices. Investors started getting jittery, as other big Indian pharma companies also faced reinspections and prolonged remediation activities. As India’s top ranking pharma company, Sun Pharma was expected to address the issues raised by the US FDA but it took more than two years for the company to receive a clean chit in the form of an Establishment Inspection Report (EIR) after an inspection conducted at the Halol facility during February 12-23 this year. The agency concluded that the inspection was now closed and the issues contained in the WL issued in December 2015 have been addressed. Calling this an important development for Sun Pharma, Dilip Shanghvi, Managing Director said, “We remain committed to following the highest levels of quality and 24x7 cGMP compliance at all our manufacturing facilities globally.” This news should settle investors, especially the corporates. In an earnings call on May 25 to discuss the Q4FY18 results, Shanghvi was quizzed repeatedly on the preventive measures taken by the management to solve the problem at Halol. Given that the facility is responsible for around 15 per cent of revenues, and with continuing pricing pressure in the US, analysts pointed out that investors were losing money. Shanghvi reassured the analysts that he agreed with some of their unhappiness and that as a large investor himself, he was also unhappy and they were trying to find a way to get the plant recertified at the earliest. He admitted that it was taking ''much longer than what we would have liked it to.'' According to him, all analysts or investors should also keep in mind that last year Sun Pharma faced 18 US FDA audits and the company came out of each of those inspections with either no 483s or a very limited number of 483s. “Halol clearly has taken much longer than what we would have liked it to, but that is a reality and we have to find a way to fix it,” said Shanghvi. His answer reveals a common angst: being pulled up for a fault, but ignored for and otherwise good performance. So even as Dr Reddy’s Labs (DRL) is likely to complete remediation activities by June-July for both its Srikakulam and Duvvada plants, it is time to count the learnings from Halol,

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It’s time to count the learnings from Halol, both internally for Sun Pharma as well as for India Pharma Inc

both internally for Sun Pharma as well as for India Pharma Inc. One major learning from Halol was that pharma companies needed to spread their product filings across multiple facilities, especially for key products and crucial markets. And no other market is as key as the US, the world’s biggest pharma market. An HDFC Securities report on the pharma sector predicts that a comeback is on the cards and one of the major reasons is that companies have diversified filings across multiple facilities. For instance, three years ago, 50 per cent of US revenues of most Indian pharma majors were contributed by two plants. Since then, the report points out that they have added manufacturing plants and diversified filings across multiple facilities. The HDFC Securities report analyses that Lupin now has seven formulation plants while Sun Pharma has built one more injectable plant (where it shifted products impacted by Halol’s WL). Sun Pharma’s Mohali plant has also received clearance from the US FDA. Cadila Healthcare, Aurobindo Pharma, Torrent Pharma and Alembic Pharma have also scaled up manufacturing base (both in numbers and capability). This has significantly reduced concentration risk with respect to future regulatory adversity. With the Halol resolution, HDFC Securities has increased the P/E multiple of Sun Pharma from 20x to 24x, a clear indication of the impact of this news on market sentiment as well as the company's perceived performance. But revenues will take time to build up as the impact of a prolonged remediation process will take time to wear off. For example, in the case of Sun Pharma’s Halol’s facility, while the volume from the unit has started to improve in the last two quarters and will continue to improve post the EIR, Shanghvi explains that “if a customer has long-term agreements (with other manufacturers), even if we are available, does not mean we will get business. So it is a process, it takes time.” Which is why the HDFC Securities report says that it is unlikely that DRL will see lucrative approvals coming in from its Srikakulam and Duvvada plants in FY19, leading to further erosion in DRL’s US base business. Thus the biggest lesson from Halol is prevention (of GMP deviations) is better than cure. That’s unfortunately easier said than done!

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com



MARKET I N T E R V I E W

The export potential of Russian pharma products is growing Recently, the Chamber of Commerce and Industry of the Republic of Tatarstan signed an MoU with the Council for Economic Development of Andhra Pradesh to promote development and diversification of economic cooperation between the two regions. On the sideline of iPhex 2018, in New Delhi, Alexey Petrovich Savelchev, Ministry of Industry and Trade of the Republic of Tatarstan, talks about the business opportunities and regulatory friendly environment in Tatarstan, in an interaction with Usha Sharma

What is the overall size of the pharmaceutical market in Tatarstan, Russia and how fast is the sector growing? The volume of the pharma market in Russia in 2017 reached $28.7 billion, which is eight per cent higher than the year before. The share of imported drugs in the market as a whole in 2017 was 70 per cent in money and 38 per cent in packages. The volume of the pharma market of the Republic of Tatarstan also showed growth in 2017 by eight per cent and amounted to $594.3 million. What steps have been taken to promote pharma research in the country? Thanks to the implementation of the state programme of the Russian Federation “Development of the pharma and medical industry for 2013-2020,� today we have a competitive, sustainable and structurally balanced pharma and medical industry. Over the past five years, the industry has attracted more than 150 billion rubles of private investment by foreign and domestic companies with a federal budget of 35 billion rubles. Under state support, 70 import-substituting Russian

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Impressive successes in the field of pharma and bioindustry in India, an efficient system of state support for innovative companies, including through cluster activation are the benchmarks for the Republic of Tatarstan

drugs were registered and brought to the market. In general, within the framework of the state programme, the development of about 400 innovative drugs have been supported. There are 35 production sites, 500 enterprises of the pharma industry work in the country. As part of the transfer of high technologies, foreign pharma companies built seven plants. At the sites of domestic manufacturers, their products were localised by 78 foreign companies, among them such manufacturers as Bayer, Janssen, Merck, Roche. According to the state register of medicines, more than 360 international nonproprietary names have been localised. For five years, we have created a good base for the development of technological competencies in the field of biotechnology. The export potential of Russian pharma products is growing. A regulatory and legal infrastructure is developed. The institute of licensing has grown, the inspectorate of foreign productions have appeared. The regulatory and legal infrastructure for supporting research in the country has been developed A portion of the costs of

implementing projects for organisations and conduct of clinical trials of medicinal products is subsidised (up to 400 million rubles) (Decree of the Government of the Russian Federation No. 1045 of 01.10.2015);A portion of the costs is subsidised for the implementation of projects for the organisation of medicines and (or) the production of pharma substances (up to 200 million rubles) (Decree of the Government of the Russian Federation No. 1047 of October 1, 2015). The bill, drafted by the Federal Antimonopoly Service, proposes to abolish the requirement for local clinical trials. Tell us about the current state of clinical trials in Tatarstan. In 2017, Russia approved 700 clinical studies, 410 of which were initiated by foreign companies.The Republic of Tatarstan currently occupies the third place among the Russian regions in terms of the number of international clinical trials conducted. To date, 45 medical organisations have been accredited in the Republic of Tatarstan for the right to conduct clinical trials. The established research


infrastructure currently has a great potential for the development and commercialisation of activities in the provision of services for the development of innovative medicines, preclinical and clinical studies, testing of innovative medical products. How do you encourage foreign investment in the pharma sector? The Republic of Tatarstan is one of the three most attractive regions of the Russian Federation. Having a developed, diversified industry, in the strategic plan, the main emphasis in the republic is on developing competencies in such modern industries as pharma, bio and nanotechnologies. The Government of the Republic of Tatarstan actively supports progressive companies developing priority areas by supporting and financing scientific research, applying additional measures of tax incentives for these sectors of the economy In addition, there is comprehensive support for investors in the placement of new production facilities in the special economic zones ‘Alabuga’, ‘Innopolis’, as well as in the areas of priority social and economic development: Naberezhnye Chelny, Chistopol, Nizhnekamsk, Zelenodolsk. Residents of these zones receive not only the finished engineering infrastructure, but also substantial tax preferences. For example, the tax on profit in the Republic of Tatarstan is 18 per cent, in the special economic zone the first five years the tax is zero per cent, in the next five years – five per cent, and until 2055 the tax will be 13.5 per cent. In the territories of priority social and economic development in the first five years, the profit tax will be five per cent, further 10 per cent. Taking into account the measures of support described by the Ministry of

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The Republic of Tatarstan is one of the three most attractive regions of the Russian Federation

Industry and Trade of the Republic of Tatarstan, the project 'FarmMedPolis of the Republic of Tatarstan' was developed in the format of a project office for targeted attraction and placement of residents in the Republic of Tatarstan.

The project provides for such a format for business cooperation, in which sites are defined for comfortable placement of new pharma productions, taking into account sanitary norms and GMP standards, appropriate engineering infrastructure


MARKET and logistics, special conditions of economic activity (preferential taxation, special customs regime, etc.)What regulatory requirements are needed to manage the growth of the pharma market? How many premises were built according to GMP standards? GMP Rules ("Production Rules and Drug Quality Control") - are analogous to the European GMP EC Rules, covering all stages of drug circulation: good laboratory practice, good clinical practice, good manufacturing practice, proper distribution practice, proper pharmacy practice, proper pharmacovigilance practice and other practices. Starting from September 1, 2010, the Ministry of Industry and Trade of the Russian Federation is licensing the production of medicines and licensing control. Starting from January 1, 2014, under the licensing control, the Ministry of Industry and Trade of Russia verifies licensees for compliance of production of

medicines with the requirements of the Rules of Good Manufacturing Practice. At present, on the basis of applications from manufacturers, conclusions have been issued on compliance with the requirements of good manufacturing practices for 274 Russian pharmaceutical manufacturers. According to the forecast of Frost & Sullivan, the demand for pharma products is likely to double in the next 10 years. What steps have been taken by the Ministry of Industry and Trade of the Republic of Tatarstan? Currently, the Ministry of Industry and Trade of the Republic of Tatarstan is actively working to develop the pharma industry of the Republic of Tatarstan and attract large bio and pharma companies to the republic and localise their production in our territory. To this end, the definition of prospective land plots in use of the territories of advanced socio-economic

development, special economic zones and in the territories of the municipal regions of the Republic of Tatarstan for the placement of pharma industries is being carried out.The next stage will be work on creating, where necessary, an industrial infrastructure for pharma production. For residents of the pharma industry, an online resource "Farmatlas" will be prepared on the basis of geomarketing, with the help of which they will be able to determine (select) a site suitable for the construction of their production. Also, work is under way to organise public large-scale industry-specific events, plans also include the organisation of educational programmes designed to meet the needs of existing pharma manufacturers and future residents. In addition, the financial institutions of innovation business support are effective in the republic. We are talking about the Technopark "Idea", which has experience in investing in

pharma production, and a foreign company that implemented a project to build a laboratory and production complex in Kazan. According to the investment agreement, the Idea Technopark took a share in its implementation (construction and equipment of cleanrooms, purchase, installation and qualification of technological equipment, equipping with laboratory equipment), after which the share of the Idea technopark was bought out by the owner. This scheme can be applied to other projects. Rustam Minnikhanov, President of the Republic of Tatarstan, recently visited India, and the Chamber of Commerce and Industry of the Republic of Tatarstan signed a memorandum of understanding with the Council for Economic Development of Andhra Pradesh. Tell us more about the MoU. The cooperation agreement between the Andhra Pradesh Chamber of Commerce and the Union of the Chamber of

Commerce and Industry of the Republic of Tatarstan was signed on April 16, 2018 to promote development and diversification of economic cooperation and expand trade ties between its companies on a mutually beneficial basis. The parties will encourage and facilitate actions aimed at developing economic cooperation and promoting trade exchange between companies and enterprises of the two countries. The priority area of cooperation for Tatarstan is the pharma industry. Impressive successes in the field of pharma and bioindustry in India, an efficient system of state support for innovative companies, including through cluster activation and the creation of a supporting infrastructure, are the benchmark for the Republic of Tatarstan. The signing of this Memorandum has strengthened the confidence that the existing huge potential of cooperation should be realised by our joint efforts.

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MARKET The III All-Russian GMP Conference is planned in Kazan. What is the purpose of organising an international conference? III All-Russian GMPconference, with international participation under the name "Russia and the world. Management of the growth potential of the

We are talking about the Technopark ‘Idea’, which has experience in investing in pharma production pharma market "is one of the important events of the pharma industry, is organised by the Ministry of Industry and Trade of the Russian Federation and the FBU" The State Institute of Medicines and Good Practices". The choice of Kazan for the conference is not accidental - now Kazan has a significant experience in holding iconic events of various subjects of Russian and international dimensions. The cultural and business environment, social stability and inter-ethnic harmony are attractive factors for external partners. It is expected that the conference will bring together leading international and Russian experts in the pharma industry, representatives of public authorities, managers and specialists in pharma industries, representatives of professional associations and communities - a total of about 1,000 participants from Russia and abroad. The programme of the event provides for discussion of the most topical issues related to building the capacity of the Russian pharma industry, the processes of integrating

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industry into the global pharma industry, and developing cooperation with the international industry community. Within the framework of the GMP-conference, the plenary session "Potential of the Republic of Tatarstan for residents of the pharma industry" is planned with the

participation of representatives of federal and republican bodies of executive power. At the initiative of the Ministry of Industry and Trade of the Republic of Tatarstan, the Tatarstan-Indian biopharma forum is also included in the programme of the conference, during which it is

planned to hold B2B meetings with the heads of republican enterprises and scientific and educational organisations, as well as a meeting with the main industry specialists of the Republic of Tatarstan. During such events, the republic can express its public position of supporting biopharma and the medical

industry, and representatives of the pharma business will be able to make sure that Tatarstan is a window of opportunity to enter not only the Russian pharma market, but also the markets of the countries of the Eurasian Economic Union. u.sharma@expressindia.com


MARKET DEAL TRACKER

Pharma industry posts 35 deals worth $5 bn in May 2018 Domestic players played more active role in deal making as compared to crossborder companies THE INDUSTRY reported 35 deals worth $5 billion in May 2018, as compared to five months average of 57 dealsworth $15.7 billion. Domestic players played more active role in deal making as compared to crossborder companies. In the healthcare industry, 58 per cent of the acquisitions were reported by domestic companies in the month. Eli Lilly topped the chart with its proposed acquisition of ARMO Biosciences, an immuno-oncology company, for $1.6 billion. The acquisition is expected to strengthen the company’s clinical portfolio with ARMO's lead immuno-oncology asset, pegilodecakin. Other big deals included Janssen Biotech’s $1 billion acquisition of BeneVir Biopharm, and another acquisition by Eli Lily in Canada. The industry reported 72 venture capital (VC) deals worth $2 billion in May 2018, as compared to five months average of 74 deals worth $1.7 billion. Some of the major deals in the month included CStone Pharmaceuticals raising $260 million in series B financing round, Brii Biosciences raising $260 million, and Moderna Therapeutics raising $125 million.

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

10-May-18

Eli Lilly and Co (US)

ARMO Biosciences Inc (US)

1,600.0

02-May-18

Janssen Biotech Inc (US)

BeneVir Biopharm Inc (US)

1,040.0

14-May-18

Eli Lilly and Co (US)

AurKa Pharma Inc (Canada)

575.0

07-May-18

Luye Pharma Hong Kong Limited (China)

Seroquel and Seroquel XR (UK)

546.0

07-May-18

Provention Bio Inc (US)

PRV-031 (US)

395.0

08-May-18

Yunfeng Capital; Citic Private Equity Funds Management Co Ltd; ARCH Venture Partners LP; Hillhouse Capital Group; Oriza Seed Venture Capital; GIC Private Limited; Sequoia China Investment Management LLP; Boyu Capital; Taikang Insurance Group; 6 Dimensions Capital; King Star Capital

CStone Pharmaceuticals Co., Ltd. (China)

260.0

24-May-18

Yunfeng Capital; Sequoia Capital China; ARCH Venture Partners LP;Blue Pool Capital; Boyu Capital; 6 Dimensions Capital

Brii Biosciences (China)

260.0

03-May-18

Merck & Co Inc

Moderna Therapeutics Inc (US)

125.0

14-May-18

ARCH Venture Partners LP; F-Prime Capital Partners

Beam Therapeutics Inc (US)

87.0

M&A (Including Private Equity) Trend Analysis

Source: GlobalData

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Venture Financing Trend Analysis

Source: GlobalData


MARKET POST EVENTS

analytica Anacon India and India Lab Expo to be held in Hyderabad The event to be held from September 6-8, 2018 analytica Anacon India and India Lab Expo are India’s largest and most important platform for the analysis, laboratory-technology and biotechnology market. They have the potential for more than 259 exhibitors and more than 7,714 visitors in three halls. The event will be held in Hyderabad from September 6-8, 2018. The event will focus on innovative and applied product and system solutions for laboratories in the industrial, research and science sectors. As the industry’s definitive forum, fair and confer-

The conference will give insights into science and research. International experts will present latest techniques ence gather all relevant information about the latest developments. Both events will cover the entire value chain for industrial and research laboratories. The focussed exhibition sectors will give visitors a comprehensive overview of the market, innovations and best-practice examples: analysis, biotechnology, laboratory technology, quality control, measuring and testing. The conference is tailored to the Indian market, so it will give profound insights into science and research. It is where international experts present the latest techniques in all application sectors. International market leaders as well as local Indian manufacturers will participate in the trade shows. EP News Bureau

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FAST-TRACK Your regulatory challenges The new Emprove® Program with comprehensive documentation facilitates your qualification process. -

Support for your risk assessment 400 Emprove® chemicals Pioneering filters and single-use components

Join us on Date: 20th July, 2018 Venue: Taj Krishna Road Number 1, Banjara Hills, Mada Manzil, Hyderabad, Telangana 500034

Find out more: www.new-emprove.com The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. Merck, the Vibrant M and Emprove are registered trademark of Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. © 2018 Merck KGaA, Darmstadt, Germany and/or its affiliates.


MARKET POST EVENTS

7 Edition of PharmaTech Expo 2018 & LabTech Expo 2018,Chandigarh concludes successfully th

This year the focus was on the pharma machinery and equipment manufacturing sector PHARMATECHNOLOGYINDEX.COM recently organised PharmaTech Expo 2018 & LabTech Expo 2018 in Chandigarh, a premier event dedicated to pharma innovation, technology and knowledge. Over a period, it has emerged as a crucial platform for showcasing the latest innovation and technologies throughout all phases of the product lifecycle, focussing on pharma manufacturing and processing technology, pharma systems and services. This year the focus was on the pharma machinery and equipment manufacturing sector and pharma packaging, pharma formulations and nutraceutical. Davesh Moudgil, Mayor, Chandigarh, inaugurated the exhibition, where in a large number of eminent industrialist entrepreneurs and foreign dignitaries were present. Satya Pal Jain, Additional Solicitor General of India and Ex MP graced the inauguration function as a special guest. The other dignitaries present during the inauguration function included, Dr Dinesh Dua, CEO, Nectar Life Sciences and Vice Chairman, Pharmexcil, Dr Rajesh Gupta, President, Himachal Drugs Manufacturers Association (HDMA), Dr Naresh Sharma, President, Indian Pharmaceutical Association (IPA), Delhi Branch & Assistant Drugs Controller (India), CDSCO and Dr D Roy, Former Deputy Drug Controller (India), CDSCO. The event was attended by 4000 entrepreneurs/ industrialist/ industrial buyers. The re-

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one to one meetings were held as part of event.

verse buyer seller meet was attended by eight representatives from African countries in-

cluding former ambassador, consultant and pharma manufacturers. Indian delegates had

opportunity to meet all representatives from abroad and during the event around 500

The salient features of PharmaTech Expo 2018 & LabTech Expo 2018 were: ◗ The exhibition was organised in the space of 7500 square meters, and 180 exhibitors participated and displayed their new technology. There were live demonstrations of machinery and equipment for producing drugs and pharma products. ◗ Indo-Africa Chamber of Commerce and Industry (IACCI) organised reverse buyer-seller meet and brought buyers from South Africa, Swaziland, Niger and Burkina Faso to interact with participating delegates. ◗ About 15 organisations including Indo African Chamber of Commerce & Industry (IACCI), The Council of EU Chambers of Commerce in India (Mumbai), PHARMEXCIL, Federation of Pharmaceutical Entrepreneurs (FOPE), Himachal Drug Manufacturing Association (HDMA), Indian Pharmaceutical Association (IPA) – Delhi Branch, LaghuUdyogBharati, Confederation of Indian Pharmaceutical Industry (CIPI), BaddiBarotiwalaNalagarh Industries (BBN), Association of Pharmaceutical Manufacturers (Dehradun), Drug Manufacturers Association (Uttarakhand), Pharmaceutical Manufacturer’s Association (Roorkee) and other industry associations and Industrial Houses gave consent as support organisations / sponsors to the event. EP News Bureau


MARKET EVENT BRIEFS HEALTHCARE SENATE 2018 Date: July 12-14, 2018 Venue: New Delhi Summary: Express Healthcare invites CXOs of hospital chains, medical directors, owners/ promoters of hospitals and diagnostic centres, consultants, thought leaders, industry stalwarts and domain experts to congregate at India’s largest private sector business summit to prepare a blueprint based on values that will make healthcare organisations successful both in terms of profitability and goodwill. The first two editions of Healthcare Senate held in Hyderabad served an excellent platform for thought leaders, key decision makers, investors and budget holders to

Contact expo@pharmatechnologyindex.com

GULF CONGRESS ON PHARMACYAND PHARMACEUTICAL SCIENCES Date: September 17-18, 2018 Venue: Abu Dhabi, UAE Summary: The theme of the conference is Global Innovations & Recent Advancements in Pharmaceutical Science. Pharma Conference 2018, an international event, will focus on the core knowledge and major advances in the ever-expanding field of pharmacy and pharma sciences. Contact Catherine Jones Program Manager Pharma Conference 2018 47 Churchfield Road, London, W3 6AY, United Kingdom

KENYA PHARMA EXPO 2018

share and exchange strategies that are relevant to the fast changing healthcare environment as well as helpful in running sustainable, responsible and profitable businesses in India. All stakeholders therefore, came together to share their insights on business models that will work for India. The first edition focussed on ‘Value-based healthcare delivery’, while the second edition was ‘Building a future ready healthcare sector for India’. Taking these discussions further and in keeping with the rapidly changing healthcare business environment, Healthcare Senate’s 3rd edition will focus on ‘Strengthening Values for Sustainable Growth’. Contact Vinita Hassija Mob: 98205990053 Email: vinitahassija@gmail.com

PHARMATECH EXPO 2018 & LABTECH EXPO 2018 Date: August 22-24, 2018 Venue: Ahmedabad Summary: The event is dedicated to pharma innovation, technology and knowledge, which will showcase the latest cutting-edge technologies needed to cost-effectively develop and manufacture quality products.

Date: October 17 -19, 2018 Venue: KICC, Nairobi, Kenya Summary: The international pharma exhibition on technologies and trade will focus on East & South African Pharmaceutical Industries. The expo will be organised by GPE Expo where pharma machinery and allied-industries OEMs across the world will exhibit their Technologies/ Services. Contact details: Paresh Jhurmarwala CEO KENYA PHARMA EXPO 2018 E-mail: contact@kenyapharmaexpo.com Website: www.KenyaPharmaExpo.com

GLOBAL PACK 2018 Date: November 23-25, 2018 Venue: Labh Ganga Exhibition Centre, Indore, MP Summary: GLOBAL PACK 2018 is an International Trade Exhibition & Tech Summit for the packaging material, machinery and ancillary industry. Organised by Integrral Business Exhibitions & Media in association with SIES School of Packaging, it is being designed to serve as a platform for the packaging and printing industry, both in terms of business and technical content. Contact Email: info@ibem-india.com

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THE MAIN FOCUS

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The draft guideline of UCPMP restricts pharma companies from a lot of traditional marketing practices, however, it opens new doors of opportunity to leverage digital platform By Usha Sharma

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ndian pharmaceutical companies spend a substantial amount of their annual budgets on promotion and other marketing activities to influence and update healthcare professionals about their company’s brand. However, often there have been allegations of unethical practices such as to luring and bribing healthcare professionals through cash and kind, to further their products and brands. In a bid to curb these unethical marketing practices in the pharma industry, the government is in the process of enforcing the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). The UCPMP guidelines refer to services that pharma companies offer to doctors such providing gifts, sponsorships to conferences, hospitality and cash or monetary grants. It also restricts pharma companies from giving away free samples of drugs and promotional material such as mailing journals. It also mentions, “Where there is any item missing, the code of MCI as per Indian Medical Council (Professional, Conduct, Etiquette and Ethics) Regulation, 2002 as amended from time to time, will prevail.” The guidelines demand a major mind-set change from the industry begin with. Dr Arun Mitra, Sr Vice President, Indian Doctors for Peace and Development, Member Core Committee Alliance of Doctors for Ethical Practices and Former Chairman, Ethical Committee Punjab Medical Council explains, “So far, some pharma companies have been saying that they have to give freebies or extra profits to doctors selling branded generic drugs because their sale will be affected otherwise. They may find transition phase difficult. But in the long run this will be beneficial.” Moreover, with the implementation of UCPMP, pharma companies will face increased government scrutiny – something that the private sector abhors. The draft rule of UCPMP guidelines gives government the power to control company activities such as production, supply and distribution, there is no saying where it will stop. Identifying the key areas, companies see its direct impact on pharma companies and in-direct on medical representatives. And if pharma companies fail to adhere the given guidelines, then they may have to face bigger repercussions. Therefore there are many who oppose these guidelines. For instance, Salil Kallianpur, Principle Consultant, Digital Transformation Lab says, “For the first time in the country, senior

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cover ) pharma executives are likely to come under the government scanner if activities that are done by their sales staff are in violation of the law. The industry has opposed outright this ‘draconian’ nature of the law and has sought relief from the Ministry of Chemicals and Fertilizers to soften the nature of penalties. However, while the UCPMP may soften them, the Essential Commodities (EC) Act is quite far reaching, and its application can have adverse consequences. Chances of companies challenging penalties will always increase since EC Act applies more to commodities and products while the UCPMP refers more to company conducts and services.” BG Barve, Managing Director, Bluecross Laboratories cautions, “Companies should take serious cognizance of the draft order because of the quantum of punishment it prescribes. Any violation of the draft code may result in the confiscation of stock of the highest selling brand of the company and suspension of marketing activity for the same brand for at least a quarter of a year.” These are some of the challenges which pharma companies are likely to face after the draft becomes mandatory, there might be more once its gets implemented.

Implementation hurdles Moreover, implementing the guidelines would be no easy task either. There are several challenges that need to be overcome and the industry has raised several concerns about UCPMP’s implementation process. Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals anticipates, “Like any new initiative, there will always be some grey areas which would require further discussion and deliberation. Based on the initial discussion among various committees, it seems that more clarification is required with respect to sampling of products, gifts. Most MNC pharma companies have a stricter internal compliance code which is complied with. I feel, in certain instances,

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physician samples have to be provided for which more clarification is needed. However, we welcome this initiative by the authorities.” Anwar Daud, Managing

Mitra, on the contrary, is in favour of stringent rules and offers a counterview, “Money spent on giving freebies should not be covered under the expenditure for the purpose of tax

pharma companies invest heavily in promotions and other marketing activities than in research. Kallianpur emphasises, “Indian pharma companies are

The digital marketing will reduce the expenditure on promotional activities. This will help cut down cost of drugs Dr Arun Mitra Sr Vice President India Doctors for Peace and Development, Member Core Committee Alliance of Doctors for Ethical Practices and Former Chairman Ethical Committee Punjab Medical Council

For the first time in the country, senior pharma executives are likely to come under the government scanner if activities that are done by their sales staff are in violation of the law Salil Kallianpur Principle Consultant, Digital Transformation Lab

A company can create innovative marketing campaigns that match the inventive products and increase market participation BG Barve Managing Director, Bluecross Laboratories

Money spent on giving freebies should not be covered under the expenditure for the purpose of tax deduction and should be taxable Anwar Daud Managing Director, ZIM Laboratories

Director, ZIM Laboratories, too highlights, “In a crowded market with several local, regional and pan Indian players competing with each other for the attention of the prescribers, it will be very difficult to eliminate practices, which have been part of the conventional marketing arsenal and almost considered part of acceptable business practice.”

deduction and should be taxable. It may sound difficult initially, but in the long run, the unhealthy, cut throat type of competition will get reduced and there will be fair play.”

Progress with R&D Before an innovative drug reaches the market, it takes years of relentless efforts by research scientists. Yet, often

not known to invest in R&D except some notable exceptions. That said, an analysis of the top seven pharma companies in the country — Cipla, Dr Reddy's Laboratories, Lupin, Aurobindo, Cadila Healthcare (Zydus), Sun Pharma and Glenmark — shows that their expenditure on R&D as a percentage of their operating income has increased from 5.8 per cent in 2011-12 to 9

per cent in 2016-17.” He continues, “According to a report in the BMJ, for every $1 pharma companies spend on ‘basic research,’ $19 goes towards marketing and promotion. These are of course global estimates, but it is safe to say that while the proportions might differ, Indian companies also spend much more for marketing than they would for R&D.” According to Daud, “On an average, large pharma companies spends about 8-11 per cent of the total turnover on R&D, while SMEs would spend far less in the range of 3-4 per cent.” Dr Tathagata Dutta, Managing Director and CEO, Etico lifesciences informs, “Companies like Sun Pharma, Dr Reddy's Laboratories, Lupin, Aurobindo, spend about 16-20 per cent on R&D while smaller companies and unethical companies like Mankind spend less than one per cent on R&D against marketing.”

Ushering research in marketing The role and need of marketing is very huge and significant. However, there is a need for more research and study to improve the efficacy and impact of marketing and to implement them in an ethical manner. The people undertaking these activities should also be more knowledgeable. Mitra says, “It is important that information about the new medicines is passed on to the clinicians by the pharmacologists instead of the medical representatives who are good at marketing but have little technical knowledge of the products. Since these days the promotional activities are carried out by the medical representatives, their sole aim remains to get profit for the company. The information in such cases may be biased sometimes.” Barve suggests, “R&D departments can act as advertising wings in the right market. R&D strategies let companies create highly-effective marketing strategies around releasing a new product or an existing product with new features.


( A company can create innovative marketing campaigns that match the inventive products and increase market participation.” So, before the UCPMP guidelines become mandatory, pharma companies need invest time and resources to understand how marketing will transform in the coming times and gear up to be ready for these changes.

The digital era So what is the way forward? Many feel that it is going to be digital. Priti Mohile, Co-Founder and Managing Director, MediaMedic Communications replies, “Digital platform offers some unique opportunities to

THE MAIN FOCUS

ROLE OF ETHICS COMMITTEE T

here will be a committee for handling the complaints names as Ethics Committee for Pharma Marketing Practices (ECPMP) in each of the associations. The Committee will have three members represented by the Executive Head of the companies or a nominee from the Executive Head, but not below the rank of Directors in the Board of Company.And their role is going to oversee and restrict any unethical practices before it reaches the next level.

break the clutter, reach in different ways and tailor the message. Utilising these in the right manner by integrating them correctly with the offline activities can ensure larger success. For this, the marketing personnel need to gear up.” Highlighting the benefits of newer means of communication, Kallianpur says, “The aim of pharma or any marketing

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practice is to create loyal customers and to serve them well in order to retain their loyalty. Even with large armies of representatives, companies have barely reached to more than 30 per cent of the doctor population in India. With technology, this number can go up 3X at a fraction of the cost of hiring the number of reps to treble coverage.”

Mitra says, “Digital marketing will reduce the expenditure on promotional activities. This will help cut down cost of drugs. However, for any new product, person to person contact is always beneficial at the initial stage.” Thus, digital technology platforms can offer pharma companies to reach healthcare professionals much more

efficient way than doing it simply through large sales forces. However, Indian pharma companies are not tech savvy and restricting themselves from adopting digital platforms. Identifying the reasons, Kallianpur says, “Pharma companies have faced self-limiting challenges as they move to digital platforms. Practising managers cannot convince themselves that digital platforms can engage their customers in ways that their medical representatives can. So, they often hide behind the shield of regulations. In western countries, regulations are much tougher, yet companies have successfully demonstrated that digital platforms successfully engage doctors and

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cover ) help to sell their products better.” Singh also highlights the slow pace of adoption of digital marketing practices and says, “The role of digital pharma marketing practices in creating awareness about medical products to doctors is quite significant, unfortunately not much progress made by Indian pharma industry, we are at the nascent stage even now. The various stages of digital marketing are: Beginners, Conservatives, Explorers, Reactioners and Disruptors. IPM is still at a nascent stage.” To overcome this hurdle, Kallianpur says, “I would suggest that companies begin with very basic digital offerings such as the use of emails to drive customer traffic to websites that host great content such as infographics, snippets, videos, gifts and text. This content holds the attention of the doctors, makes them come back and over time helps to differentiate the company. The trick is not to replace the representative with this, but to augment their doctor calls with these channels.” Mohile adds, “Pharma companies might need external support to educate them in a much wider way. Most pharma companies have faced challenges as they move to digital platforms. It begins with getting the right employees to run digital as well as the right agencies. A well prepared team who understands all the nuances or is trained in it can help reduce the challenges. Unfortunately, most try to apply print principles to digital which can lead to failure. Many try to undertake activities in-house, which can give sub-optimal results since this media is multifaceted and needs in-depth understanding, especially when it comes to use of social media. Additionally, regulations in pharma have to be understood and taken care of even when using social media. When they are unable to meet all this, one tends to blame the media and shy away from using it. Some companies are fearing to take the first step even today.”

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Benefits galore The adoption of technology will not only reduce marketing cost and help pharma companies to increase their bottom lines, but can also help in updating health-

markets too.” Many pharma companies are focussing on specialising their presence in niche areas which needs better attention. Kallianpur informs, “This

Improved patient engagement is an another benefit of digital platforms. Barve explains, “Digital marketing allow more engagement with patients, the focus on communication

digital marketing involves a combination of elements that need to be considered as part of a healthcare company's digital strategy.”

Digitalising corporate branding

Based on the initial discussion among various committees, it seems that more clarification is required with respect to sampling of products, gifts Sanjit Singh Lamba Managing Director, Eisai Pharmaceuticals

Companies like Sun Pharma, Dr Reddy's Laboratories, Lupin, Aurobindo, spend about 16-20 per cent on R&D while smaller companies and unethical companies like Mankind spend less than one per cent on R&D against marketing Dr Tathagata Dutta Managing Director & CEO, Etico Lifesciences

Pharma companies might need external support to educate them in a much wider way Priti Mohile Co-Founder and Managing Director of MediaMedic Communications

HOW DID ITALL BEGIN? T

he drafted rule of UCPMP was designed in 2011 by the Department of Pharmaceutical (DoP) and after immense discussion between industry stakeholders and governing bodies in 2015, it had been decided to make it mandatory under the Essential Commodities Act. However, the Law Ministry rejected the UCPMP draft claiming that it did not align with the requirements of the Essential Commodities (EC) Act under which, the UCPMP was supposed to become formal legislation.The ministry also sought to understand whether the draft was similar to the code of conduct as mandated for doctors by the Medical Council of India.”

care professionals about all communicable and non-communicable diseases. Mohile says, “In India, there are a lot of disease areas that requires visibility and awareness. While chronic conditions like diabetes are very important, it is the under-diagnosed and neglected conditions that need visibility. This will help grow

increase correlates with companies shifting their focus to speciality and differentiated drugs such as biosimilars and supergenerics. R&D to improve formulations of these medicines help to differentiate them and seek a premium in a crowded market. However, investment into R&D pales in comparison to marketing spends.”

remains firmly with doctors. Given the time constraint of doctors and changing demographics, digital marketing with healthcare professionals are beneficial, because more and more healthcare professionals don't want to see sales representatives, but would prefer to see company products at a time that suits them. Successful

The shift in marketing approach will also help companies in corporate branding. Creating a credible corporate brand to compel the prescriber to prescribe a family of sub-brands based of quality / value for money etc. will help companies in the long run. Barve finds a perfect example as he says, “The highly–regulated nature of the pharma industry has led to a very cautious approach to using social media. But those companies who have been willing to invest in this new approach have found that it has given them a competitive edge over traditional digital marketing techniques.” Kallianpur also says, “For some strange reason, pharma companies never thought it to be beneficial in building trust with patients. Despite being the consumers of its products, the industry never thought it important to be in direct touch with this group through trust building activities. This can only be attributed to pharma’s unhealthy obsession with promoting its brands at every chance it gets (the government forbids drug advertising in India) rather than engaging creatively with its stakeholders to build trust and loyalty. Hopefully, it should be in consideration as pharma explores digital pathways and the possibilities that they provide.” Thus, UCPMP guidelines is set to change the way pharma marketing is done and digital technologies will have a major role as the industry undergoes this transformation. Industry experts should anticipate the changes and gear up to deal with them effectively. They should also develop strategies to help them turn challenges into opportunities and stay ahead of the game. u.sharma@expressindia.com


MANAGEMENT

Driving change at Novo Nordisk As Novo Nordisk implements a change strategy to expands its focus from diabetes to other chronic conditions like obesity, it is betting on its ‘market-fit’ approach to countries like India to shore up slowing growth in mature markets. By Viveka Roychowdhury

F

ive years short of its centenary, Danish Novo Nordisk, source of nearly half of the world’s insulin, is re-inventing itself. In his letter in the 2017 annual report, outgoing Chairman of the Board of Directors Göran Ando acknowledged the market realities of a highly competive US market and pricing pressures, but held out hope, that “under Lars Fruergaard Jørgensen’s leadership, Novo Nordisk has started a change process that will make the company more competitive in the new business reality.“ A key part of this change process has been an updated R&D strategy implemented in 2017, with the company looking beyond diabetes, into other serious chronic disease areas, like obesity and cardiovascular disease to start with. This change strategy is supported by hard facts. According to statistics from the eighth edition of the IDF Diabetes Atlas dated 2017, of the over 425 million people living with diabetes globally, only 13 per cent are being treated with insulin. Of this 13 per cent, the company estimates that only six per cent are on Novo Nordisk insulin. However, obesity is an even bigger challenge than diabetes, with an estimated 650 million obesity patients of which only 11 million are on anti-obesity medication. Yet, obesity is still not taken as seriously as it should be. Novo Nordisk sees this neglect of obesity as an opportunity to widen its therapeutic focus areas and by extension, its patient pools. Reviewing

Obesity research is almost at the same level of maturity as type 2 diabetes was two decades ago Mads Krogsgaard Thomsen Executive Vice President and Chief Science Officer, Novo Nordisk

The Novo Nordisk market strategy for India is to bring the entire portfolio, segmenting society, physicians and patients and then making them all available

It takes long to document safety and efficacy for a chronic disease like diabetes Lotte Bjerre Knudsen Scientific Vice President, Novo Nordisk

Maziar Mike Doustdar Executive Vice President, International Operations, Novo Nordisk

his first year at the helm as CEO in the 2017 annual report, Jørgensen’s vision of where he’d like to take the company reflects this widending focus. Besides solidifying Novo Nordisk’s position as the world’s leading diabetes care company, his vision includes being the world’s leading company in the medical treatment of obesity, and among the leading companies in haemophilia. The company clocked total

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net sales of DKK 111,696 million last year, with the diabetes care focus area bagging the largest share (81 per cent) with a growth of three per cent. No surprises that while the obesity segment was just two per cent of net sales, it had a 60 per cent growth, while haemophilia stayed steady at 9 per cent, and growth disorders degrew by 24 per cent to end up with a six per cent share of Novo Nordisk’s 2017 total net sales.

The growth of three per cent in diabetes care clearly shows that maintaining pole position in the diabetes market can only get more challenging. As Novo Nordisk is only too aware. At a press meet held at the company’s headquarters in May, Jørgensen explained that US sales in the previous year were impacted not just due to the pricing policies of the US government as it seeks to reduce healthcare costs, but

also due to other factors like the presence of 2-5 competitors in the long acting insulin market, a domain where Novo Nordisk has been market leader for decades as well as channel consolidation and increased negotiation power of pharmacy benefit managers But midst the gloom, there is a silver lining, however slight it may be. As more competitors enter Novo Nordisk’s previous stronghold of long acting insulin, the company is now focussing on the next generation of molecules: GLP1 analogies, like liraglutide and semaglutide. Sales growth in 2017 was primarily driven by Tresiba (insulin degludec, a once-daily newgeneration insulin), Victoza (an analog of human GLP-1 liraglutide, positioned as an injectable to improve blood sugar in adults with type 2 diabetes) and Saxenda (a higher dose of liraglutide, the 'first and only FDA-approved weight-loss medicine in a pen that helps you lose weight and keep it off', as per the product website). These products are expected to continue to be major growth drivers in the coming years together with Ozempic, the company’s once-weekly, injectable GLP-1 treatment for adults with type 2 diabetes launched earlier this year. The GLP-1 segment’s value share of the total diabetes care market has increased to 11.8 per cent compared with 9.7 per cent a year back, as per the 2017 annual report. With pricing pressure in the US, the Danish company's largest market, expected to

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MANAGEMENT

NOVO NORDISK’S MARKET COMPOSITION AND SHARE IN DIABETES CARE ACROSS REGIONS

continue, the company also rejigged its marketing operations in 2016, appointing Maziar Mike Doustdar as head of an expanded International Operations area. Of the two operational units, North America Operations and International Operations, the former is facing headwinds and thus there are sustained efforts to ‘market fit’ the company’s strategy for the latter. What this means is

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that each country market will follow a portfolio, market access and sales strategy tweaked for the local realities and needs of each individual country. There are early signs that this strategy is paying off, as the 2017 annual report shows that while sales growth was flat in the North America operations, it was driven by International Operations, with the main growth contributors

being AAMEO (Africa, Asia, Middle East and Oceania), Europe, China and Latin America. In value terms, while North America might equal the International Operations, bets are on the latter to be the future growth engine, at least as far as volumes go. Again, numbers support this asumption: the company estimates that of the 7.6 billion people in the world, 95 per cent of them live in the 190 countries that

make up the expanded International Operations area.

Tailored for India As per data from prescription sales tracking agency AIOCD AWACS, Novo Nordisk ranked 25 th in the Indian pharma market this May, with Mixtard as the leading brand clocking sales worth ` 46 crores. Novo Nordisk’s India specific market strategy is centred around patient af-

fordability. As Mazair Mike Doustdar, Executive Vice President, International Operations, Novo Nordisk, points out, “India is the only country in the world where all of Novo Nordisk’s products are available. From human insulins, to the products in between to the company’s flagship products, and the newest latest most innovative insulins, which are multiple times more expensive than the human insulins.”


MANAGEMENT The company has a manufacturing collaboration with Ahmedabad-based Torrent for insulin. As Doustdar puts it, “India is one of the very few places in the world where 40 unit insulin vials are used. In the rest of the world, even if they (patients) are on vials, they are on 100 unit vials. The reason for the 40 unit insulin vial is patient affordability. As most patients in India pay outof-pocket for medical expenses, the 40 IU vial allows them to stock up on their insulin needs from the pharmacy corner/ chemist and meet their insulin requirements for the next few days, rather than the 100 unit vials which would last for longer but would mean a higher purchase value.” As Doustdar emphasises, “The price is extremely affordable even for those with less means. We have found this to be a sustainable model for Novo Nordisk and Novo

Of the two operational units, North America Operations and International Operations, the former is facing headwinds and thus there are sustained efforts to ‘market fit’ the company’s strategy for the latter Nordisk operations in India. Many companies have long abandoned human insulin, (because) margins are much smaller, and if you really want to maximise profitability then you should sell the more expensive things.” According to him, the company felt that the Indian pandemic of diabetes could not have been solved with just the expensive products. But couldn’t the company reduce prices on its more expensive medicines as well? “Reducing the price of the flagship products all the way down to hu-

man insulin, would mean that we can operate for a few days and then have to pack and move on. Our model would be very different. The value that is driven from the flagship products is what fuels the innovation of the future that India is in hunger off and in need off,” is his reasoning. Thus “the Novo Nordisk market strategy for India is to bring the entire portfolio, segmenting society, physicians and patients and then making them all available. This has been our way of addressing the affordability problem”,

summarises Doustdar.

Going beyond medicine But Doustdar points out a sad reality that price no matter what it is, even if it’s one dollar, is too much. “There are portions of society, that live well below the poverty line and we need to do something very different for them.” Doustdar claims that this is where the Novo Nordisk patient outreach programme, the Changing Diabetes in Children (CDiC) programme. Given the growing challenge of diabetes in India,

Novo Nordisk India set up the Novo Nordisk Education Foundation (NNEF) in 1997 as a non-profit organisation with the purpose of increasing awareness and education on diabetes and other healthcare issues. The NNEF rolled out the Changing Diabetes Barometer programme, in Public Private Partnership (PPP) with seven state governments (Madhya Pradesh, Bihar, Goa, Puducherry, Andhra Pradesh and Orissa) and has reached out to more than 700,000 people for diabetes awareness. CDiC covers 16,700 children spread over 13 countries globally. The ambition is to reach over 20,000 children by 2020. In India, over 4,000 children are part of CDiC. He relates how in most cases, the fathers of children on this progamme do not earn more than a dollar a day so most of these children would not have been able to afford

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NOVO NORDISK’S R&D PIPELINE ACROSS THERAPEUTIC AREAS

insulin on their own. As he puts it,“Without our help and support, they (the children) would die. So we give them free insulin until they are either 18 or get a job or earlier, and (thus) give them a life that they would not otherwise have. All of these CSR activities in India are a very large part of our DNA in operating in India, in addition to making our drugs available.” Doustdar also refers to the work done by the World Diabetes Foundation (WDF), which was founded by the company in 2002. From 2002 to 2017, the WDF provided $138 million in funding to 535 projects in 116 countries. For every dollar spent, WDF raises approximately 2 dollars in cash or as in-kind donations from other sources. In India, over the last five years, WDF has supported multiple projects in the states of Maharashtra, Kerala, Madhya Pradesh, Tripura, West Bengal, Uttar Pradesh, Nagaland, Assam, Rajasthan, Manipur, Sikkim, Tamil Nadu, Delhi, Gujarat, Bihar, Jharkhand, Meghalaya, Puducherry, and Punjab, among others.

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R&D reinforced Novo Nordisk has nine R&D centres (four in Denmark, two in the US, one each in in China, UK and India).In 2017, Novo Nordisk’s R&D costs amounted to DKK 14 billion (equal to 1.8 billion Euro), representing 12.5 per cent of sales. This was spread across five strategic priority areas: diabetes, obesity, haemophilia, growth disorders, and other serious chronic diseases. R&D employs approximately more than 5,600 people in seven areas. According to Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer, Novo Nordisk, “We expect it (R&D costs) will increase somewhat, because we have picked all the low hanging fruits and of course as we move into new areas, the risk of failure will probably increase. So we may need to have more projects.” He is philosophical about this saying, “Pharma R&D scientists better like failure. Because the failure rate is so high.” At the heart of Novo Nordisk’s change strategy is

the expanded focus from diabetes to obesity and other associated conditions, which are relatively not as well researched. As Thomsen puts it, “Obesity research is almost at the same level of maturity as type 2 diabetes was two decades ago, when type 2 diabetes was referred to as ‘non insulin dependent diabetes‘ and was not given as much importance (as type 1 diabetes).” According to him, Novo Nordisk’s R&D productivity measured (against) other companies has been quite high in terms of how much they've used compared to how many products they’ve put out to the patients. (See figure: Novo Nordisk’s R&D pipeline across therapeutic areas) Supporting this argument, Lotte Bjerre Knudsen, Scientific Vice President, Novo Nordisk gives the example of liraglutide. She relates how it was first made in 1997 and got on the market in 2009. In her opinion, 12 years from discovery to market is actually not that much above (industry) average.

“It takes long to document safety and efficacy for a chronic disease like diabetes,” she reasons. “We did face some delays early on, as we had to learn to produce liraglutide. And also, we got the dose wrong in the early clinical trials so we had to do another Phase 2 trial. We also struggled a little bit as one of the study animals (mice) had cancer in the thyroid. It turned out probably not to be relevant to humans but we spent a few years extra on that. I think what always kept it interesting, is that there are all these many effects at the same time and everything was manageable. It kind of became my baby and I fought hard for it. But I always had the support of Mads (Thomsen) who always made sure that we got the resources to support the research.” The Novo Nordisk research pipeline has some big milestones expected in the next two years. As Thomsen puts it, “The Holy Grail for us is to convert our biologics medicines into tablets.” Patients would much prefer a pill to an injection, and this

would automatically increase adherence as well. On the obesity front, as obesity is the main driver of type 2 diabetes, the company will seek to maximise weight loss in humans by targeting several mechanisms. Thomsen indicated that semaglutide would be the anchor drug when developing new antiobesity medicines Thus Novo Nordisk finds itself looking at a future where its flagship product, insulin, may cease to be its calling card. The company grew out of the love of the founder Nobel Laureate August Krogh for Marie wife who also happened to be a type 2 diabetic. Built on the premise that safe and affordable insulin should be available for all diabetics, can the company expand this philosophy to other disease conditions, at price points that are sustainable, for both patients as well as its balance sheet? viveka.r@expressindia.com (The author was part of a press meet organised by the company)


MANAGEMENT INSIGHT

Selling in the new age In the first of a new series of articles, Mohan G Joshi, international business coach and speaker on sales and leadership, elaborates on how the new age buyer has redefined the sales business cycle. He also speaks on the strategies to win over the new-age buyer SELLING HAS changed so completely that the definition of selling, marketing and that of the salesperson too needs to undergo an official makeover. While the same two people are at the two ends of the bridge – the seller and the buyer; they are now completely different creatures who need a closer study. If the seller needs to win over the new-age buyer, then a deeper study of buyer behav-

iour, his choosing and buying process, new-age selling tools and tactics need to top the todo list of the salesperson. The salesperson of today needs to be more of a trusted advisor, a coach, a friend and an impartial well-wisher and less of a ‘salesperson with just one goal – that of pushy-selling’. The buyer too has also undergone a complete change and expects more than just information from the salesper-

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son. The alignment between buyer expectations from the salesperson and the delivery by the salesperson dictates the future of the ‘good old order’.

What’s the new age sales cycle like? What happens when you have to wait for the buyer to decide when s(he) wants to interact with you as a salesperson? You know that the sales cycle

has changed forever. The buyer of today has more control over your sales cycle as it is s(he) who decides when you and s(he) should connect on the first sales call. Conventional sales cycles had the salesperson in control of the cycle. But, the modern sales cycle has the buyer decide on important things. In the older version, the salesperson used to make a call, fix an appointment, meet, hand

over sales literature, explain things, follow up, repeat and go laughing all the way to the bank, having closed the sale. The modern version has the buyer first do the groundwork (mostly on and through the Internet) on the product. S(he) uses Google, the company website, the other product review sites, LinkedIN, Twitter, Facebook and whathave-you to do preliminary research on the company,

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MANAGEMENT product and the reviews. Through the same channels, s(he) studies your competition, checks out product feedback, seeks more information and then after all this is done, ‘reaches out’ to you - the salesperson. The new-age sales cycle is thus sleek, multigeared, and designed for the new-age buyer, In fact, half the sale is done BEFORE the salesperson gets to connect with the buyer!

recognise this and educate the customer with new information on not just his own product but on the best ways of doing business or by offering him new insights into his customers and markets.

What’s the best way to win over the new age buyer?

When is the best time to sell to a new age buyer? Simply put, the best time to sell is whenever your buyer is ready. When the meeting does take place, the buyer demands more information to corroborate the information he has gathered, his findings and analysis. It would not be incorrect to say that the buyer has made up his mind (almost!) before he meets with you, the salesperson. If you are lucky, s(he) is inclined towards your product; and if you are out of luck, s(he) has made up her mind against buying your product. Either way, there are sales tactics to nudge the buyer towards your product. In the first instance, you need to be a supporter and take the ‘about-to-happensale’ in the right direction by providing reasons that will give the buyer a feeling that he has made the right decision. More facts, statistics, case studies - where you help in furthering the buyer’s positive views, intentions, opinions and emotions, will go a long way. If you are out of luck, and the buyer has decided against you, then you need to use the information you have about the buyer, his details, his buying history, his preferences and leverage this information to nudge him slowly and steadily to move in favour of your product. Feel lucky, dear salesperson that you are talking to a warm prospect and not to a stranger you met on a cold calling spree. The new-age selling (or buying process) does all the preliminary checking beforehand and

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In the new-age, selling and marketing are no more silos; but more like friends who have to be BFFs, if you use the newgeneration slang

whoever gets in touch with you from the pipeline are largely warm prospects. By using data, companies today are ensuring that they spend their monies on reaching the right audience, then filtering out cold prospects using data analysis and mining, to finally focus on the warm and hot prospects. This is a more efficient selling process, as companies reduce the cost of customer acquisition by making it a digitally-enriched and labour-non-intensive process. The salesforce can thus focus on the warm prospects, saving on steep

cold-calling costs and making sure there is no opportunity cost to be borne.

Are the days of the pushy salesman over? Pushy salespersons are history or may soon become part of it. Today's mantra is: push and you will get pushed out of the playing field. Pushing a sale is an old-school tactic, the new boys and girls in sales are adopting a challenger stance. They know that yes men or naysayers do not win, but a challenger stance does. An intelligent salesperson will

Reviews. Views. Points of views. These are the new pulse points of the new age buyer. The buyer is going to rely on what is being said in the world wide web about your product. S(he) is going to read a lot of reviews or talk to his/her tribe (family, friends, digital friends) about your product and analyse the sentiment towards your product before s(he) weighs its advantages or gives it a thumbsdown. His/her point of view is largely dependent on reviews and views offered by users of the product and influencers in the industry. Your buyer is going to rely more and more on word-of-mouth, which to him/her is the most credible form of ‘marketing’ and the most reliable way of arriving at a decision. It is up to you to create effective content that will be useful to attract influencers; and to balance the use between owned, paid and earned media. Owned media – is the media that you own such as your website, your social media channel etc. Paid media is the media that you buy to showcase or advertise your product such as relevant and effective platforms, social media and sites. Earned media is a PR term, where you get ‘covered’ or ‘featured’; this is pull PR and not paid media. Today, customers treat all these three as one; and make their buying considerations based on the messages that they see on all the three. The most credible source is earned media of course and if your company is doing a good job and a good job with its content and distribution, then earned media is a strong possibility. Word of mouth is the best way to gain buyers favouring you. Creating effective content, how and where

you distribute it, with what frequency and how well you create the ‘opportunity to see’ is going to help your buyer see your product in a positive light. This will ultimately decide if you are going to ‘win’ the ‘sale’. Remember, your buyer will meet your product first and you, later. What you do to ensure s(he) smiles when s(he) meets your product is what matters in selling!

What should be the new equation between selling and marketing teams? If you understand how a buyer ‘buys’ in the new-age you will make peace with your marketing team as a salesperson and vice versa. In the new-age, selling and marketing are no more silos (they never were; but were seen so); but more like friends who have to be BFFs (best friends forever), if you use the new-generation slang. Marketing dresses up your product so that when it meets with the buyer on any online platform, the buyer likes what s(he) sees; marketing continues to ensure your buyer bumps into your product in more places and often, but at the right time. The buyer is enamoured and that’s when your ‘selling’ takes over. Again, the data that has been collected and collated by marketing is what you need to study and use while ‘doing the sale’; eventually leading to ‘the closing of the sale’.

Parting shot You will see that sales has undergone a complete makeover and is still changing. Whatever the industry, the sale process has changed. Be it an IT company, a pharma company, or an FMCG company, selling has donned a new avatar. As a salesperson, it is imperative for you to understand this new avatar of selling; to understand how buyers will behave in a constantly changing and upgraded market scenario. It is important for you to know and adapt to the changing scenario, learn new tactics, get new tools on your side and practise the art of new age selling.


RESEARCH UPDATES

China approves first home made anti-HIVdrug The drug can block the fusion of the virus and host cell membranes, interrupting the HIV life cycle in its earliest stage hina has approved the first domestically developed, long-acting injectable HIV drug Albuvirtide which could be a boon to tens of thousands of HIV/AIDS patients in the country, the official media reported. The drug, approved by the China Food and Drug Administration, can block the fusion of the virus and host cell membranes, interrupting the HIV life cycle in its earliest stage, state-run Global Times quoted a report from Science and Technology Daily.

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costs for HIV-infected patients, it wrote. Current HIV treatments used in China are either generic or imported. AIDS and HIV patients mostly took a handful of pills every day, Peng Xiaohui, a sexologist at Central China Normal University, said. “China’s first domestically developed drug offers new HIV patients a new treatment option. We hope to dispel the fact that China has not developed good anti-AIDS medicine,” Xie Dong, Chief Scientist and Former Head of Frontier

Albuvirtide is injected once a week and is secure, a staff from the Nanjingbased Frontier Biotechnologies Inc, surnamed Zhu, told Global Times. Compared to imported anti-HIV drugs, Albuvirtide has fewer side effects, especially on the liver, state-run Xinhua news agency reported, quoting Wu Hao, head of the infection centre at Beijing You’an Hospital. The drug is a fusion inhibitor that should be used with antiretroviral drugs to treat people with HIV condition who have received antiviral therapy, the company said. Albuvirtide could potentially enhance patient compliance, improve quality of life and reduce treatment

Biotechnologies Inc was quoted by the Science and Technology Daily as saying. Several companies are developing long-acting AIDS drugs in China, but only Frontier’s drug has been approved, the Xinhua report said. Peng said the patients have to overcome psychological obstacles first since they need to inject medicine on their own or have a doctor do it for them. According to official data China has 718,270 people suffering from HIV/AIDS in China. As of the end of June last year, 221,628 people had died of AIDS-related diseases in China, according to a Xinhua report of December 2017. PTI

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RESEARCH

Novartis wins key European panel’s thumbs-up for migraine drug The company has not said what it will charge in Europe, where prices differ from country to country NOVARTIS’ NEW migraine drug Aimovig won a key recommendation from a key European panel, helping open the way for potential sales before the end of the year for a medicine the Swiss drugmaker is counting on to boost growth. After receiving the nod from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) the drug for treating migraine headaches in adults still needs approval by the European Commission, but it usually follows the CHMP recommendation. The drug, developed by Novartis and Amgen, Aimovig won approval in the US two weeks ago. The medicine, also called erenumab or AMG334, is the first in a new class of treatments designed to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the

brain. In the US, Amgen and Novartis are pricing the self-injection drug at $6,900 a year, or $575 a month, before discounts. There, prescription benefits managers had taken aim at the drug, announcing in advance that they saw it as a test case to

help rein in prices. Novartis has not said what it will charge in Europe, where prices differ from country to country. Competition could eventually also become fierce. Companies including Teva Pharmaceutical Industries, Eli Lilly &

Co and Alder Biopharmaceuticals are developing similar treatments. Novartis and Amgen are selling Aimovig in the US. Amgen has commercialisation rights in Japan, while Novartis has the rights elsewhere. Reuters

Allergan oral migraine drug succeeds in study Allergan, which aims to bring the first oral CGRP to the market, has two such drugs in its pipeline ALLERGAN SAID its oral migraine drug met the main goal across all doses in a study, with a statistically significant reduction in monthly headache days in patients with episodic migraine. The treatment, atogepant, belongs to a class of migraine drugs also being developed by Eli Lilly and Alder Biophar-

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maceuticals that target a protein associated with pain signaling called calcitonin generelated peptide (CGRP). Last month, the US Food and Drug Administration approved Amgen's CGRP treatment Aimovig, which is self injected monthly and will have a list price of $6,900 a year, or $575 a month.

Questions have been raised about Amgen’s strategy for Aimovig after the nation’s largest manager of prescription benefits, Express Scripts, told Reuters it is pressing Amgen and rival makers of new migraine-preventing drugs to reconsider the usual strategy of high list prices and hefty rebates.

Allergan, which aims to bring the first oral CGRP to the market, has two such drugs in its pipeline. Last month, the company reported positive results from a second late-stage trial for the 50 milligram dose of its other migraine drug ubrogepant. Reuters

AbbVie’s rheumatoid arthritis drug succeeds late-stage study ABBVIE SAID its experimental drug met the main goal of halting progression of moderate-to-severe rheumatoid arthritis in a late-stage trial. The drug, upadacitinib, was tested as a monotherapy in patients who have not been treated with chemotherapy agent methotrexate. Upadacitinib, which belongs to a class of drugs known as JAK inhibitors, also helped improve symptoms of the disease such as swollen joint counts, the company said, adding it plans to submit a US marketing application in the second half of 2018. AbbVie, whose drug Humira is the market-leading treatment for rheumatoid arthritis, is among drugmakers developing JAK inhibitors, which work by blocking inflammationcausing enzymes known as Janus kinases. Last week, the Food and Drug Administration approved lower doses of another JAK inhibitor developer by Eli Lilly and Incyte Corp, but gave it a label that analysts said could restrict its potential for use in a larger population.


PHARMA ALLY I N T E R V I E W

We are prepare to face challenges in regulated markets of Europe and US Manoj Mishra, AVP - Sales and Marketing, Uniworth Enterprise, speaks on the current scenario of pharma packaging market and shares the company’s plan to strengthen its footprint in the global market, in an interaction with Swati Rana

Brief us about Uniworth’s existence in pharma packaging segment. Uniworth Enterprises is part of Meghmani Group. The group companies are engaged in manufacturing activities in India and also have offices and warehouses in Turkey, South Africa and the US. The group has diverse manufacturing interests like speciality chemicals agro chemicals, Dyes/OBA and API intermediates, digital printing inks and PVC Polymer processing. Uniworth is the foremost manufacturer of PVC-based quality packaging materials that caters to the pharma and food industry. Raw materials are sourced from reputed

international and indigenous suppliers. We have experienced and well-trained team of professionals that ensures our products,i.e. Alu Alu laminate, Rigid PVC films, PVDC coated PVC films and Triplex are superior packaging solutions at best prices. Uniworth Enterprises with its location in Ahmedabad, is ideally suited to efficiently cater to the Indian market and with ICD facility and excellent connectivity by road to Nhava Sheva port, Mumbai, can also service the global export market with minimum time lag between production and export. Our factory is dust free and fully air conditioned and is equipped to meet stringent quality requirements of

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PHARMA ALLY the pharma and food packaging requirements including but not limited to FDA and BRC. The manufacturing unit is spread across an area of 29,000 square metres with built up area 6,000 square metres. The calendaring unit and the PVdC Coating and Alu/Alu Laminate lines, with its critical European parts, ensures we produce quality product at all times. How do you see the pharma packaging market in India? India has positioned itself as a manufacturing hub for pharma packaging segment. In recent times, few global companies have also put up their manufacturing units in India. India is offering quality economical solutions to the global market and is growing at more than 14 per cent CAGR. In the coming days, Indian pharma packaging market has huge scope and Uniworth having multiple product offerings like Alu Alu

laminate, and 60 micron PVC along with thermoforming PVC, is surely going to emerge as a global player in pharma packaging segment. Which products do you offer? Brief us about the company’s USP? Uniworth’s production is conducted in controlled environment and contamination free area complying with international quality standards, accomplishing all the packaging needs with state-ofthe-art infrastructure. Our USP is that we have technological advancement in manufacturing and our ‘L’ shape five roll inverted calendar is capable of producing PVC from as low as 60 microns to as high as 700 microns in thickness. This makes us capable of producing CFB (Alu Alu with In-house 60 micron PVC ) and on the other hand, we produce rigid PVC of 200 to 700 microns thickness with medium and high Impact

catering to pharma blistering and non-pharma segments. The deep draw property with high tensile strength films are most suitable for cake domes, salad bowls and other deep draw applications. How much does this segment contributes to company’s annual turnover and what is company's annual turnover? Uniworth Enterprises is a new venture founded in 2017, closely held business segment and part of Maghmani group, having an annual turnover of $540 million. We started in July 2017 and after our quality validations, we have been selling approximately 200 tonne per month of PVC and 50 tonne of value-added products. In the year ended March 2018, our business shall contribute to a sizeable value and we forecast a value achievement of ` 100 crores by the financial year 2018-19. Brief us on the global presence of the company in

pharma packaging. We are making efforts to take our products to the global markets and are prepared to face the challenges of regulated markets of the US and Europe. In continuation to this process, we already have DMF registration of all our products, i e, PVC, PVDC and Alu Alu. Our India manufacturing capabilities are equipped with global cGMP standards. Our all the machine lines, i e, calendering machine, lamination machine, PVDC coating with dry laminating machine, slitting machines, core cutting machines and stripping machines, and vision inspection systems on technical parameters, have an edge over our competitors. What is company’s expansion plan for next five year? In near future, we have plans for putting up additional calendar of 1,000 tonne capacity to cater the fast growing global market of

pharma and food packaging. Presently, we have calendaring capacity of 600 tonne, but our value-added products capacity is of 300 tonne for lamination and 200 tonne for coating. So to meet the gap of calendering need for our own value-added products and lamination products, we need larger calendaring capabilities. And, we are prepared to put additional calendaring line enhancing our PVC capabilities. What will be the road map for the next five years? Our vision is to put our brand UNIWORTH on the global map as a leading manufacturer of pharma packaging. Scaling up PVC and PVDC production capacities and taking cold form blisters to global markets with in-house 60 microns PVC. Uniworth is going to be a major player of Indian origin in pharma packaging industry in near future catering to the global markets. swati.rana@expressindia.com

VENDOR NEWS

Werum ITSolutions and Nymi in partnership As part of the collaboration, the two companies are developing joint solutions for the smart authentication of employees on the pharmaceutical shop floor WERUM IT Solutions, the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharma and biopharmaceutical industries, and the authentication expert Nymi have entered a strategic partnership. As part of their collaboration, the two companies are developing joint solutions for the smart authentication of employees on the pharma shop floor – an important prerequisite for ensuring data integrity and increasing efficiency in the pharma and biotech production. “Together with our customers and partners, we evaluate new technologies for operating concepts on the shop floor of the future,” says Christiane

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Dickel, Product Manager, Werum IT Solutions. “The use of an innovative wearable for authentication has proven to be very promising. We are looking forward to working with Nymi and are confident that our new

joint solutions will add significant value to customers in the pharma and biopharma industries.” Nymi offers wearable, biometric authentication solutions that are backed by Nymi’s Enter-

prise Management (NEM) console for ease-of-deployment, security and privacy, while greatly increasing productivity. The Nymi Band is a multi-factor biometrically authenticated wearable that is worn by shop floor workers to perform day-to-day authentication tasks, such as digital signatures within an MES. Once setup, the user simply has to put on the Nymi Band and authenticate using their fingerprint. The device will then remain authenticated for as long as it remains on the user’s wrist. As an extra layer off security, the band also has sensors to read the wearer’s electrocardiogram, this confirms that the person wearing the Nymi Band and placing their finger on the sensor is in-

deed the authorized person. This authentication solution will be fully integrated into Werum’s PAS-X MES and is intended for use in already existing systems as well as by new customers. “We are excited to be bringing our wearable authentication solutions to the life sciences industry with the market leader, Werum IT Solutions. As manufacturing becomes increasingly digital, we believe the value of continuous authentication will play a critical role to increase data integrity, but also maximise productivity, providing a substantial leap forward for manufacturing IT,” says Shawn Chance, VP Strategy, Nymi. EP News Bureau


PHARMA ALLY

Caliber opens office campus at Sanathnagar Industrial Estate The campus was inaugurated by the IT Minister of Telangana, KT Rama Rao CALIBER TECHNOLOGIES, has taken a new leap in realising their global vision. Caliber recently inaugurated its new state-of-the-art office campus at Sanathnagar Industrial Estate. The campus was inaugurated by the IT Minister of Telangana, KT Rama Rao, who spoke highly of the company and the campus which he said was “at par with any MNC in Hitech City”. The campus has a built-up area of over 39,000 sq ft that can accommodate over 600 employees. It will also house a 24x7 global support centre, a product experience centre, which will showcase a real time experience of Caliber’s products, an upcoming incubation centre to support start-ups, and an open-air theatre suitable for discourses, discussions, and performances. To create a good work-life balance for the employees at Caliber, the campus has a badminton and basketball ground, a gymnasium with all amenities, as well as a child-care centre. The campus is inclusive by design to sup-

port easy access to differently abled persons. Even the environment has been taken into consideration at the campus with a zero water-wastage design as well as a bio-waste composting pit which will collect bio-waste and turn it into organic manure for all the vegetation in the campus. Alongside Sri KT Rama Rao, the guests of honour were Sri Jayesh Ranjan, Principal Secretary of I&C and IT, Telangana, E Venkata Narasimha Reddy, Vice-Chairman and MD, TSIIC, Amarnath Reddy, Chief Relations Officer, IT Dept, Govt of Telangana and M Madan Mohan Reddy (Chairman, Pharmexcil). The event was also attended by the CEOs and CXOs of top pharma companies - all customers of Caliber. The company also launched its CSR foundation. Caliber’s CSR foundation has been formed to contribute in addressing key issues such as rural health and education. The CSR foundation will work with local

NGOs in rural areas of Telangana to meet these objectives. Caliber has launched its Data Sciences division, which will have products that can help pharma companies make key product-related decisions faster and easier. These products will provide solutions preconfigured analysis (reporting system for each product), Quality Metrics (required parameters for Quality Metrics – OOS , deviations, trending, etc), Root Cause Analysis (understanding rea-

sons for a failure, dependent reasons analysis, etc), Predictive Analysis (a tool that can predict a failure, output quality or time based on process input parameters), and Machine Learning (a tool that keeps a check on parameters of interest and makes available important information handy for decisionmakers). All these products aim towards enhancing the way pharma companies make decisions for the products and quality.

Caliber has also made the decision to visually re-brand itself this year – its 17th year of existence. The entire evening culminated in the launching of its new logo. The logo is designed to represent ‘Redefinition’ – something the company has consistently done since its inception – within the organisation as well as for the companies it caters to. With its products redefining the way companies work and think about Quality, Compliance and Automation, Caliber’s team believes they have redefined themselves time and again over the years by expanding their product line, increasing their reach to other parts of the world like the US, Asia-Pacific, UK, Europe and South Africa, and growing a team to 350 to enhance project deliveries and support. Caliber knows and advocates that success is assured when one understands the need to redefine themselves and makes that decision to do so. EP News Bureau

PRODUCTS

New 70-micron Nozzle for Videojet 1860 Continuous Inkjet Printer VIDEOJET Technologies, a global leader in coding, marking and printing solutions, has introduced a new 70-micron nozzle for the Videojet 1860 Continuous Inkjet (CIJ) printer, offering a number of improved code benefits to manufacturers. The new 70-micron nozzle for the Videojet 1860 CIJ provides a higher contrast print through a larger drop volume that helps to create crisper, clearer codes. For manufactures who require the code to remain traceable through the lifetime of the product, the nozzle delivers superior print quality that enables the printed code to stand out on the packaging, and remain visible on the

product. “The new 70-micron nozzle for the Videojet 1860 CIJ printer offers manufacturers a number of extended benefits, including higher contrast codes, enhanced code readability and improved substrate adhesion,” comments Anthony Blencowe, Global Business Unit Director, Videojet Technologies. Videojet understands that there are many substrates that can challenge the code quality and ink adhesion on the product. The new 70-micron nozzle also offers improved substrate adhesion, helping to mark codes more clearly. This is especially improved on demanding code-resistant substrates

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such as film, shrink wrap and laminated pouches. The new nozzle also utilises technology that produces larger ink drops to better cover the inter-drop spaces, offering

improved quality codes. Manufacturers can benefit from enhanced readability of larger or stretched messages with the new 70-micron print head. All inks currently available for the 1860 60-micron nozzle are now available for the new 1860 70-micron nozzle. The 1860 CIJ ink range has been specially formulated for optimal performance and maximum uptime, allowing increased ink compatibility that can be matched for most applications. Videojet inks are designed for varying applications and production environments, allowing them to develop with changing production needs today, tomorrow and in the future.

The Videojet 1860 CIJ delivers performance without surprises, and has been designed using revolutionary technology to ensure consistent and reliable production uptime. The unique nozzle design delivers a cleaner start and print, with longer runs over wide ranges of changing production environments increasing confidence in code quality, with no surprises. Anthony Blencowe, Global Business Unit Director at Videojet adds, “The 70-micron nozzle is a great addition to the 1860 printer solution, delivering performance without surprises.” Contact details www.videojet.in/1860.

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PHARMA ALLY

Gandhi Automations’efficient dock levellers GANDHI AUTOMATIONS, India's No.1 Entrance Automation and Loading Bay Equipment Company, has bagged recognition over years of hard work, innovation, commitment to quality and reliable customer service. The company is also proud to be certified to ISO 9001: 2008. 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 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 minimising 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.

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.

Efficient loading and unloading the goods

Telescopic lip dock levellers

The importance of efficient loading the 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 the 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 solutions based on such scientific approach and feedback from clients. The dock levellers offered by the company ensure loading and unloading with

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 Automation’s Dock Levelers are equipped with the most secure safety devices and accessories.

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Camfil launches CC6000 air cleaner AMBIENT INDOOR air pollution is a problem, affecting human health and organisational productivity across levels. With an aim to fight and combat this invisible threat, Camfil, a global leader in the air purification industry, today announced the launch of CC6000- an innovative, energy efficient and cost-effective air cleaner for the Indian market. Catering to large indoor premises of upto 10,000 sq feet per unit, CC 6000 air cleaner is one stop solution for dusty envi-

lesser effort and minimal cost. It is possible to load and unload 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 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 leveler is put in 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.

Radius lip dock levellers Radius lip dock levellers allow

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

ronments and large indoor premises such as pharmaceutical facilities, food factories, heavy industry, paper mills, welding workshops, timber facilities, warehouses, offices and supermarkets etc. It is well equipped to perform efficiently and offers an unmatched solution even for specialist applications such as upgrading of clean room environments and other classified assembly environments. With flexible installation options for both mobile and stationary needs, the unit can also be ceiling mounted. Commenting on the launch, PKSV Sagar, Managing Director, Camfil India, said, “We all are aware of deteriorating outdoor air quality of majority of Indian cities, but rarely do we find the focus on the levels of indoor air quality especially across workspaces. Occupational exposure to airborne concentrations of specks of dust, vapours, fumes, and gases constantly impact the health and productivity of employees. With CC6-Your data has been truncated.”


PHARMA ALLY VALUE ADD

Sustainability in pharmaceutical processing: Meeting ecological challenges Increasing urbanisation, smaller household sizes and an ageing population are fundamentally changing the expectations towards more sustainable pharmaceutical processing and packaging. According to Carsten Weiss, Vice President Engineering, Bosch Packaging Technology, manufacturers, material and packaging suppliers, as well as mechanical engineering and waste management companies need to join forces in order to develop truly sustainable packaging and processing concepts. An insight GIVEN THE demographic change and more responsible consumer behaviour, the current trend is toward smaller portions. This can be seen in the growing demand for convenience and on-the-go products. In many growth markets, small portions are also the number one choice due to consumers’ limited financial resources. As a result, packaging sizes are becoming smaller, yet the number of individual packages is constantly on the rise. Although the sense of environmental responsibility among the general public is improving, every year more than eight million metric tonne of plastic litter find their way into the ocean, due in part to insufficiently established or poorly implemented waste disposal processes. According to figures from the UN, this amounts to roughly one garbage-truck load per minute. In parallel, more and more effort is being put into the development of sustainable packaging and environmentally friendlier manufacturing processes.

The spirit of sustainability But what good does the most environmentally-friendly packaging design do if it is not compatible with processing and packaging machinery? Or if the process steps involved in its manufacturing, filling, packaging and disposal involve much higher energy consumption? All parties involved in the

production and supply chain have to work together to devise more sustainable solutions. Various parties are already working hand-in-hand to find new solutions that reflect the spirit of sustainability. When it comes to achieving these goals, expertise from disparate, not directly related fields can be vital. For example, the automotive industry has been investing heavily in optimising materials and processes for the past several years. With regard to products which have extremely high barrier requirements, like battery cells, the spotlight is on optimising flexible packaging materials. Lessons learned from these efforts can — provided they are available — be directly applied to the development of new packaging solutions and production concepts for pharmaceuticals.

Focussing on energy recovery Conserving resources is a key aspect of sustainability in the processing and packaging industry. In the energy-intensive pharma industry, for example, innovative energy recovery concepts are yielding significant savings. In the sterilisation process, heating and cooling energy are recovered, which can mean up to 40 per cent lower heating costs and 60 per cent lower cooling costs. When it comes to ultra pure steam generation and distillation, the latest-generation systems use a pre-heater to

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Carsten Weiss

reduce hot steam consumption by roughly 30 per cent. In cleanroom production, up to 65 per cent lower energy costs in connection with hot and cold water, steam and electricity can be achieved with the help of cutting-edge isolator technology depending on the air supply system used.

Managing resource consumption with industry 4.0 The latest software solutions in the area of digitisation show how manufacturers can conserve resources with their existing machines and lines, by asking questions like: which machines consume the most electricity? At which point in which process step do we use most energy? Thanks to the progressive connectivity of production, we now enjoy

Latest steam generators and distillation units can reduce hot steam consumption by roughly 30 per cent

access to more and more data, which can also be used for consumption analysis: sensors provide data, for instance on energy and compressed-air consumption, allowing us to

analyse these parameters over a given time frame. These often very different types of data can be bundled and analysed on a single platform, and displayed in real-time on the

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PHARMA ALLY Human Machine Interface (HMI) of a given machine or line. In this way, fluctuations, peak loads and irregularities can be identified – and effectively remedied. Thanks to industry 4.0, we will soon be able to use increasingly detailed data, paving the way for more fundamental analyses ranging from individual machines to entire plants. In turn, predictive analytics will help us spot potential sources of higher consumption and errors in advance – and identify corresponding potentials for optimisation, leading to more efficient and resourceconserving production processes.

Design, material and machine Several different aspects are important in the context of selecting suitable packages and processes: in addition to cost efficiency, more attention is being paid to barrier properties, processability, mechanical requirements, quality, and compliance with regulations. In this regard, sustainability will become more and more important in the future. When it comes to developing new packaging concepts and systems, factors like recycling, energy and resource efficiency have already become an integral part of performance specifications. Leading processing and packaging machinery providers are already working closely together with their customers in various pilot projects to develop comprehensive solutions based on a trinity of design, material and machine. For example, the use of light-weight materials in freeze drying systems can reduce the amount of mass that has to be cooled and heated, which has a positive effect on energy consumption. Moreover, the design of product shelves in freeze dryers may be optimised to ensure rapid cleaning: slightly tilted shelves, for instance, enable water droplets to quickly drain from the surface, shortening the cleaning and drying time. The tilt angle also improves the performance of the CIP nozzles, reducing water consumption. This joint development can

36 EXPRESS PHARMA June 16-30, 2018

Modern isolators in cleanroom production can achieve energy savings of up to 65 percent in connection with hot and cold water, steam and electricity

best be achieved by getting material manufacturers, brand owners and their customers on board at an early stage. As part of the UX (User Experience) approach, feedback is collected on various parties’ expectations and needs, and is then directly integrated into further developments. In addition to individual customer needs, regional specifications like legal requirements, consumer mentality and the degree of automation in production also have to be kept in mind. Only then can solutions be found that will allow the emerging markets to establish ecologically sound production, packaging and disposal concepts in their own regions. And this can only succeed if producers and materials developers, packaging manufacturers and mechanical engineering firms, as well as logistics, waste management and recycling companies act in concert, so that the entire packaging industry actively contributes to more sustainability.

Optimised freeze dryer design can lead to shorter cleaning and drying times


PHARMA ALLY VALUE ADD

Opportunities to digitise pharma operations Pooja Patil, Corporate Communication, B&R Industrial Automation, gives an insight on how pharma companies can digitise their operations, increase efficiencies, enhance product quality and fulfil regulatory compliances INDUSTRY 4.0 IS ALL about creating seamless connectivity in between machines, processes and people within and beyond manufacturing facilities to increase quality, productivity and profit from the power of advanced data analytics. By these next-generation automation solutions, pharmaceutical manufacturing companies can digitise their operations, increase efficiencies, enhance product quality and fulfil regulatory compliances. In addition, pharma companies are tasked with examining data at every stage of their manufacturing process, right from the time raw materials arrives until the final product is packed and sent for distribution. In traditional pharma facilities, the references and information about drug formulation, production and equipment and data of QA-QC are manually entered in data sheets, which are prone to human errors and can even be manipulated. With such non real-time information, it is difficult for management to take corrective actions and make timely decisions. However, with connected plant and IoT solutions, manufacturers can access data in real-time to monitor production, quality, overall equipment effectiveness (OEE) and condition of equipment. It also enables, mass customisation and batch size one with cost-effective production.

Improved operational efficiencies With IoT, manufacturing facilities can monitor data from shop floors in real-time enhancing process efficiencies. In pharma industry, appropriate quality assurance

selling their equipment and systems in all corners of the world. Modern communication is helping bring distant locations closer. But for OEMs, having customers around the world also comes with its share of new challenges. The situation becomes even complex during periods of extensive maintenance and unplanned downtimes. To avoid incurring travel costs of service technicians and engineers around the world, OEMs are

is important. Without it, companies cannot guarantee that the product conforms to necessary quality and safety standards. Many a times, product quality suffers because of machine downtime. In such cases, monitoring conditions of assets in real time can help in increasing equipment availability, preventing unplanned downtime. Condition monitoring solutions are able to predict device failures using real time data

The new remote maintenance solution from B&R makes diagnosing and maintaining machinery and equipment easier and secure. The solution utilises latest IT and security standards, enabling significant savings with low investment. With B&R’s remote maintenance solution, a service technician can access machines from anywhere in the world to retrieve logbook entries, application data and much more. When a customer’s equipment or machine is not working, every minute counts and there is immense pressure on maintenance and production teams to get the machine up and running. If a service technician is not available on-site, it can be hours or days before expert assistance is available. With B&R remote maintenance solution, a technician can connect, diagnose, adjust parameters and resolve errors – all in a matter of moments.

Enabling mass customisation

helping scheduling service, thus enabling maximum life cycle usage of a product, maximising machine uptime resulting in improved OEE. Management can make faster and smarter business decisions with the use of real-time data of operational insights. IoT helps prioritise business decisions to reduce operating costs. B&R condition monitoring modules precisely detect cases when service work may be needed and are extremely easy to configure. All these modules are part of the X20

To subscribe: bpd.subscription@expressindia.com

control system series and can therefore be used in any control topology with no limitations. A special feature of these modules is that they perform vibration analysis locally, right on the module. The availability of fully processed results minimises the time and cost of integration. These results also provide detailed insight into the system mechanics, allowing existing processes to be optimised with maximum efficiency.

Digital remote access Indian pharma OEM’s are

increasingly relying on remote maintenance. Connected devices enables real-time monitoring of equipment, so engineers can remotely identify faults quickly and improve after sales service. Remote maintenance makes diagnosis and maintenance of machinery and equipment easier than ever. Service technicians can access machines from anywhere in the world. The secure remote maintenance solution utilises the latest IT and security standards and allows for significant savings with low investment costs.

Demand for individualisation is creating new business opportunities for everyone. However, while executing this, high ratio of setup costs to unit production costs act as a bottleneck in the manufacturing process. With latest industrial transport systems, manufacturers can overcome this challenge. Next-generation industrial transport technology delivers key advantages for advanced manufacturing solutions. The flexible, operatorfriendly conveyors make production more efficient while simultaneously improving product quality. This makes the production line more economical and effective at any volume from mass production down to batch size one.

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B&R’s versatile industrial transport systems, SuperTrak and ACOPOStrak helps to achieve the increased demand effectively and efficiently. Based on long-stator linear motors, B&R’s next–generation industrial transport systems are constructed with IP65 dust and water protection and smooth surfaces that are easy to clean. The hygienic design certifies operation in food grade environment. The industrial-grade design ensures high availability and reliability with 24/7 operation. Dependable, precise and remarkably low maintenance – ACOPOStrak melds seamlessly with robotics and CNC systems to create integrated production lines. The flexible tracks used in the system make production more efficient, simultaneously improving product quality. This helps in making the production and packaging lines economical and effective at any volume from mass production down to

38 EXPRESS PHARMA June 16-30, 2018

batch size one. By eliminating the need for buffer zones, they allow for a substantial reduction in track length compared to conventional belt conveyors. They also make much more efficient use of the

remaining space by utilising curve sections and incorporating reverse movements. Products can be transported flexibly and independently and then grouped together at a station to be processed as a

batch. Overall, the production process can be accelerated by up to 50 per cent for a significant boost in productivity. B&R’s smart-factory motion control used in the transport technology helps to achieve

key advantages as maximum availability, high-speed transport and positioning, rapid changeover and fault-tolerant high quality. ACOPOStrak boosts the overall equipment effectiveness (OEE), multiplies return on investment (ROI) and accelerates the time to market (TTM). IoT might be in its nascent stages of adoptions, but its eventual impact across the global pharma sector are indisputable. IoT helps in the standardisation of the manufacturing process along with data integrity. By systematically monitoring and analysing large volumes of data, manufacturers can benefit in terms of improved production efficiency, productivity, reliability and quality. IoT provides manufacturers with a holistic view of production, raw materials and distribution, leading to better and feasible analysis of the processes thereby increasing operational efficiency.


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PVC RIGID FILM FOR BLISTER FORMING

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Autoclavable & Sterile Disposable Goggles

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Tablet Press Vantix P Series

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For almost over 20 years, Sejong has enjoyed your trust and patronage. To all who stand by us, we thank you for your faith and support We will do our best each time.

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Corporate office: 107, ACME Industrial Park, I.B. Patel Road, Goregaon (E), Mumbai - 400 063 Tel: 022-26865341/42/43 Mobile: 9833767752 Email: info@gaylordpharmasystems.com Website: www.gaylordpharmasystems.com

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Pride in Every action To widen our offerings and horizons through innovation & technology, we have extended our hands for Technical Collaboration for mutual benefits to enable us spearhead in Turnkey, Single window Solution to Customers. We are associated with companies like - Loedige GmbH, MPE USA, CSP ireland, RML Engineering, New Zealand.

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• Flexible wall barrier technology ideal for containment processes/dust free operations. • Available in MOC PU, PE and PVC anti-static for better compatibility with various solvents, SS scaffolding and Base tray for glovebag positioning & fitting. • Bespoke design and can be integrated with new and existing equipment/ process. • Ergonomic studies for better process understanding. • More visibility due to the transperent/ optical clarity of the glovebag. • System can be static / under negative pressure or positive pressure with AHU. • WIP (wash in place) arrangement for cleaning of the system. • Wide range of equipment can be integrated by using containment technology. • Applications: In API Industry - Weigh balance, reactor charging, Centrfiuge, Nustche filter, Multi Mill, Sifter & Pack off can be integrated with flexible containment system. In Formualtion R & D - High shear mixer, FBD, Blender, compression machine, auto coater, Blister pack can be integrated with Flexible containment system. • Possible OEL validation can be perfomed in Flexible isolator .

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PHARMA LIFE AWARDS

Dr Cyrus Poonawalla conferred with ‘Doctor of Science Hon.’ University of Massachusetts recognises him for his commendable work in the field of vaccines

T

he University of Massachusetts recently conferred Dr Cyrus Poonawalla, Founder of Serum Institute of India, with the Honorary Degree of “Doctor of Science Hon” for his commendable work in the field of vaccines. Dr Poonawalla said, “I am grateful to the University of Massachusetts for recognising our work. I strongly feel that we need to treat the field of vaccination with the respect it deserves. It’s not just another field related to medical science. But one of the most important ones. We need more precautionary measures than cures for betterment of human life and vaccination is one such measure.” Along with Dr Poonawallah, physician-scientist Huda Y Zoghbi and Duke University nursing leader Marion E Broome were conferred with the Honorary Degree of ‘Doctor of Science Hon.’ for their accomplishments as well. EP News Bureau

Sun Pharma receives CSR Award The company’s CSR initiatives benefitted around 1.2 million people from 3800 villages spread over 11 states in India last year SUN PHARMACEUTICAL Industries has received a Corporate Social Responsibility (CSR) Award from the Federation of Gujarat Industries (FGI) for outstanding contribution in the field of CSR. The award was presented to Sun Pharma for its CSR efforts in the areas of healthcare, education, safe drinking water, sanitation and hygiene, environment conservation, rural development, dis-

54 EXPRESS PHARMA June 16-30, 2018

The award was presented by Maneka Gandhi, Union Cabinet Minister for Women & Child Development, Government of India aster relief and malaria elimination. The company’s CSR initiatives benefited around 1.2 million people from 3800 villages spread over 11 states in India last year (2017-18).

FGI instituted the biennial FGI Awards for excellence in 1993 to honour and felicitate individuals, organisations, institutes and industries in 14 different categories.

The award was presented by Maneka Gandhi, Union Cabinet Minister for Women & Child Development, Government of India at the 15th FGI Awards function organised at

Vadodara, Gujarat. On behalf of Sun Pharma, the award was received by Dr Azadar Khan, Sr VP – Corporate Relations. Earlier in the year, Sun Pharma was conferred with the ‘CSR Leadership Award’ for making a positive impact in the lives of marginalised & backward communities. The award was given by World CSR Congress. EP News Bureau



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

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