Express Pharma (Vol.13, No.9) March 1-15, 2018

CONTENTS MARKET

Vol.13 No.9 March 1-15, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury*

CELEBRATING WOMEN POWER 10 Pg16

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

PPL CONCLAVE 2018 TO BE HELD IN HYDERABAD

DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble

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Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer) Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

MANAGEMENT

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HOW 2018 WILL UNFOLD?

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NEED FOR SUPPORTIVE CARE IN ONCOLOGY WILL INCREASE DURING THE NEXT DECADE

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LATE-STAGE CKD-INDUCED COMORBIDITY THERAPEUTICS MARKET TO REACH $10.5 BN BY 2026

RESEARCH

DELABCON 2018 HELD IN HYDERABAD

PHARMA ALLY / PACKAGING SPECIAL

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THE SIES SOP/PTC HAS A LONG ASSOCIATION WITH THE PHARMA INDUSTRY

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LILLY BREAST CANCER DRUG WINS EXPANDED US APPROVAL

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'COUNTERFEITING HAS BECOME THE CRIME OF THE 21ST CENTURY'

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STUDY FINDS NEW SUPERBUG TYPHOID STRAIN BEHIND PAKISTAN OUTBREAK

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THE IMPORTANCE OF DESIGNING SMART INTEGRATED DRUG DELIVERY SYSTEMS

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

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EDITOR’S NOTE

A spring cleaning at the CDSCO?

F

ebruary saw a fairly massive churn in India's drug regulatory infrastructure.

We now have a new Drugs Controller General (India) (DCG(I) with Dr GN Singh handing over charge to Dr S Eswara Reddy. Though the Ministry of Health and Family Welfare circular mentions that he will hold the post for three months, given that he has already been part of the system as Joint Drugs Controller, it is expected that Dr Reddy will continue as DCG(I). On February 20, 22 drug inspectors/technical officers were transferred out of the CDSCO head quarters to various zones across the states while another 20 had transfers within the states. In addition, four deputy drug controllers also received their transfer orders.

Another top level transition, though not as smooth, was Dr BD Athani’s elevation as Director General of Health Services (DGHS), Union Ministry of Health and Family Welfare. He took over from Dr Jagdish Prasad, who was sent “on a 15-day earned leave” on January 17, with the leave being extended every few days, as there were “disciplinary proceedings for major penalty .... pending,” reportedly in relation to him trying to influence a selection panel in favour of one of his juniors. Even though he was asked to go on leave to allow “the regular departmental action to be conducted ...without any prejudice or impartiality,” Dr Prasad reportedly resumed office on February 20 and was given a choice of being suspended or extending his leave. He chose the latter, extending his leave to April 30.

Dr Prasad's fall from grace is particularly striking, given that he was conferred one of the nation's highest honours, a Padma Shree, in 1991 in recognition of his pioneering work done to establish and develop the cardio-thoracic and vascular speciality at Safdarjung Hospital, New Delhi and economise the cost of cardiac surgery.

However his record has not been without blemish.

Media reports refer to his 2009 removal from the post of medical superintendent of Safdarjung Hospital and principal of its medical college. He was accused of administration related mismanagement, though he was later cleared of these charges.

While the general consensus on social media was that the churn in CDSCO was long overdue, one wonders if there was a specific trigger. Or should this be seen as another manifestation of Prime Minister Modi's anti corruption crusade?

And if so, are there more changes in store? Either way, pharma companies in India would do well to further deepen their focus on quality compliance,

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SOPs and guidances, and transfers of drug inspectors for that matter, are not magic bullets and can only be a first step on a long journey

the key message from this year's IPA Quality Forum.

Three years ago, the Indian Pharmaceutical Alliance (IPA) Quality Forum (QF), consisting of six founding member pharma companies, and supported by McKinsey & Company as knowledge partner, embarked on a journey to raise the bar and indeed, come clean about quality standards within their companies.

Most of the six companies - Sun Pharma, Cipla, Dr Reddy Laboratories, Lupin, Cadila Healthcare, and Torrent Pharma – have faced varying degrees of quality related regulatory censure. Indeed, even as the six CEOs discussed the way forward in the CEO Forum, Sun Pharma was issued a 483 notice with three observations.

The mood was introspective as Sun Pharma's Managing Director Dilip Shanghavi described how his company was closely observing the auto industry to understand it's strategy towards meeting high quality compliance benchmarks.

The journey over the past three years has not been easy, but is there finally light, however dim, at the end of the tunnel? In an update presented at this year's IPA QF meet, data presented by McKinsey seemed to show that while India accounts for seven per cent of global US FDA approved manufacturing sites, the country's share of inspections has come down and outcomes improved during 2017. Indeed, the previous inspection of Sun Pharma’s Halol facility had ended with nine observations so the fact that the recent audit, from February 12-23, ended with just three, could be seen as a positive sign.

Are we clutching at straws? Or is this real progress? Over the last three years (with the FY14 taken as October 2013 to September 2014 and similarly for FY15,16 &17), there has been a reduction in data-related errors but gaps in investigations and root cause assessments is now a leading source of non-compliance, according to McKinsey's analysis of warning letters (WLs) and 483 observations.

The focus of the next year is to scale up IPA QF interventions to other IPA members. The Forum is sharing the learnings as guidance documents and SOPs, with all the presentations made on the two day IPA QF uploaded on the IPA website. Of course, SOPs and guidances, and transfers of drug inspectors for that matter, are not magic bullets and can only be a first step on a long journey.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENTS

PPL Conclave 2018 to be held in Hyderabad 100+ leading pharma packaging professionals attending the event

E

xpress Pharma is launching Pharma Packaging and Labelling (PPL) Conclave 2018. To be held on March 15 – 16, 2018 at Novotel Airport, Hyderabad, PPL Conclave 2018 is the platform for packaging leaders, experts and veterans to come together to discuss, debate and deliberate on current and future trends in the industry, as well as the growth drivers and challenges. It would also provide the delegates and participants with ample opportunities to network and form meaningful alliances.

For the 100+ leading pharma packaging professionals attending the event, the two-day event offers them an opportunity to get updated on the advancements in India’s pharma packaging sector; gain insights from thought leaders in the pharma, biotech and packaging industries; acquire access to solution providers with cutting-edge packaging

technologies; discuss on the role of packaging in gaining a competitive edge; network with the who’s who of the pharma packaging industry; review demonstrations of innovative packaging solutions.

Topics which are likely to be discussed during the event are: ◗ Packaging in times of e-pedigree

◗ Fostering an ecosystem for pharma packaging innovation: Where small is big ◗ Pharma packaging and labelling trends in the next decade ◗ R&D in pharma packaging ◗ Smart packaging and its potential ◗ Eco-friendly pharma packaging ◗ Talking packaging (Communication)

◗ Assuring quality, safety and success with pharma packaging ◗ Pharma packaging: Enabling competence, compliance, communication

Delegate profile includes ◗ VP/Director/Head/GM Packaging ◗ R&D Packaging Heads ◗ Packaging Development Managers

◗ Packaging technologists ◗ Quality Assurance Professionals ◗ To be held at the Pharma Packaging and Labelling (PPL) Conclave 2017, the PPL Leadership Awards will honour innovation and excellence in the field of packaging. It seeks to recognise the contributions and achievements of packaging and labelling heads of reputed pharma institutions and organisations in furthering progress in the pharma industry.

As part of the PPL Conclave 2018, a handbook, featuring the top leaders in pharma packaging industry will be released.

Featuring the stalwarts, innovators and game changers ushering growth and excellence in this industry and partnering India Pharma Inc’s progress, the book will provide valuable insights on the trends, opportunities and challenges in this fast evolving and rapidly growing sphere.

EP News Bureau

Healthcare Sabha to be held in Pune from March 8-10, 2018 Healthcare Sabha 2018 will bring together policy makers, thought leaders, national and international health organisations, social entrepreneurs, and technology and ancillary healthcare service providers INDIAN EXPRESS Group and Express Healthcare will organise the third edition of Healthcare Sabha in Pune from March 810, 2018. Healthcare Sabha 2018 will bring together policy makers, thought leaders, national and international health organisations, social entrepreneurs, and technology and ancillary healthcare service providers.

Delegate profile includes, Secretary, Addl Secretary, Jt

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Secretary, DG, DDG etc from Ministry of Health & Family Welfare, Government of India, NHM Mission Directors of various states, NHM policy makers and planning officials, dignitaries from Central Drugs Standard Control Organisation DCG(I), Jt Drugs Controller, Deputy Drugs Controller), Key dignitaries from NHSRC/ SHSRC, NIHFW, dignitaries from state health corporations,

state health society and state health mission director, director, deputy director of autonomous institutions like AIIMS, JIPMER, PGIMER,

NIMHANS etc.

Dignitaries from ESIC (Director General, Medical Commissioners, Deputy Medical Commissioners) DG – AFMS, Addl. DG-AFMS, DG, ED, Director, Deputy Director – Railway Health Services, CMOs of various railway zones, Chief Procurement Officer, Medical Superintendents, Administrative Heads of premier Government and Municipal Hospitals

from various states and cities.

The first two editions of Healthcare Sabha held in Hyderabad and Vizag provided an excellent platform for researchers, policy makers, healthcare practitioners, public health advocates to share and exchange evidence drawn from research and experiences in health development programmes in India.

EP News Bureau

DELabCon 2018 held in Hyderabad The conference offered six sessions and a conversation on lab design, flexibility, sustainability, safety and energy saving DELABCON 2018, the third annual conference on laboratory design and engineering, recently concluded in Hyderabad. The venue had been specifically selected, keeping in mind the fact that Hyderabad is a hotbed of design, construction and renovation of high performance research and development laboratories of major pharmaceutical and chemical companies. The

conference was inaugurated by speakers of national and international repute together.

Participants came from countries like Canada, China, Denmark, France, Germany and the US. There were participants from Ahmedabad, Bengaluru, Hyderabad, Mumbai, Vapi, Tirupati, Pune and Kolkata.

The conference offered six sessions and a conversation on

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Speakers at DELabCon 2018 event

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MARKET lab design, flexibility, sustainability, safety and energy saving. The sessions included various case studies too. A panel discussion on Laboratories 2030: Designing for tomorrow revealed the designing trends in the future. Speakers and panellists featured some of the industry’s top thought leaders like Nitin Killawala of Group 7 Architects-India, Nimish Patel of Abhikram-India, Andrew Sinnamon of Mott Manufacturing-Canada, Chip Albright of Creative SolutionsUSA, Kamlesh Mehta of Citizen Industries-India, Soren of Broen Labs-Denmark, Archana Salil of Arena Consultants-India, Megha Gangrade of Design4-India, Arjun Phukan of Asecos-India, Ajit Kadam of Spectrum Designers-India, Lipika Nair of TexAssist-India and Patrik Unterdorfer of Trox Technik-Germany.

The conference facilitated display of various innovative laboratory products and unique designs through different means.

Aniruddha Patwardhan, Founder and CEO, Setu Creations Consultancy Services which organised the event said, “The ever growing response to this event over the last three years, gives us a confidence to widen the scope year after year.”

DELabCon published a souvenir on the occasion of this convention.

EP News Bureau

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(L-R) Dr Rajesh Babu Dandamudi, Sri Sathya Sai Central Research Instruments Facility, Chip Albright of Creative Solutions-USA, Lipika Nair of TexAssist-India, Ajit Kadam of Spectrum Designers-India, Andrew Sinnamon of Mott Manufacturing-Canada

(L-R) Nitin Killawala of Group 7 Architects in a conversion with Architect Archana Salil of Arena Consultants-India

Audience

MARKET GROWTH TRACKER

IPM clocks ` 119868 cr in January 2018 Indian companies continued to dominate the IPM with their share of 80 per cent for the month of January 2018 THE INDIAN Pharmaceutical Market (IPM) clocked ` 119868 crores and grew at 5.7 per cent as of MAT January 2018 and was valued at ` 10381 crores for the month of January. The retail sector was valued at ` 101,349 crores as of MAT January 2018 and showed a growth of 6.4 per cent. The IPM showed a double digit growth on monthly basis where 12.3 per cent growth was recorded for the month of January 2018.

Top 10 companies showed a strong growth of 14 per cent over SPLY growth and clocked a combined revenue of ` 4522 crore and captured a 44 per cent share in the IPM. Seven of the top 10 companies grew in double digits with Mankind (19 per cent), Macleods (18 per cent) and Alkem (17 per cent) showing the strongest growth for the month of said. Companies in 11-20 bracket also grew strongly at 13 per cent combined Aristo (16 per cent) and Intas (15 per cent) were among the fastest growing companies.

Top 10 brands in the IPM were valued at ` 341 crores combined and showed a growth of 15 per cent. All the top 10 brands showed a positive growth with six of them growing in double digits and Lantus (29 per cent), Clavam (24 per cent), Janumet (23 per cent), Foracort (23 per cent) and Augmentin (21 per cent) growing at more than 20 per cent. Brands ranked 11-20 grew at an even better pace and displayed a combined growth of 21 per cent which was majorly due to strong growth for Panderm+ (109 per cent) as well as double digit growth of six other brands. These brands were valued at ` 238 crores for the month.

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For more details please contact processsolutionsindia@merckgroup.com Merck, the vibrant M, Millipore, Lynx® are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates.

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Slide

Twist

MARKET Indian companies continued to dominate the IPM with their share of 80 per cent and grew combined at a strong 13 per cent growth rate. MNCs on the other hand grew in single digits at 9 per cent with their share at 20 per cent in the IPM. Eight of the top 10 Indian companies registered a strong double digit growth. Sun Pharma grew at 9 per cent while Mankind (19 per cent) was the fastest growing Indian company followed by Macleods (18 per cent) and Alkem (17 per cent). The top MNC Abbott grew at par with the IPM at 12 per cent whereas only Novartis (-4 per cent) grew negatively among the top 10 MNCs. Acute therapy with a growth of 13 per cent continued its trend of last few months of growing better than chronic therapy which grew at 11 per cent. Acute therapy maintained its share of 64 per cent in IPM as compared to chronic’s 36 per cent share. The growth for acute therapy has mainly been due to a continued strong performance by anti-infectives which grew at 16 per cent.

Also, respiratory’s 19 per cent and Derma’s 14 per cent growth over SPLY added to the growths for acute therapy. In chronic the top therapies cardiac (10 per cent) and anti-diabetes (12 per cent) also grew in double digits.

Anti-infective therapy was valued at ` 1246 crores with a strong growth of 16 per cent.

All of the Top 10 molecules grew in double digits with Amikacin (31 per cent), Cefpodoxime Solids (29 per cent) and Ceftriaxone Injectables (26 per cent) showing the fastest growths. Top molecule Amoxycillin and Clavulanic Acid Solids also showed a strong 21 per cent growth. All top 10 brands also showed a strong double digit growth with the No 1 brand Augmentin growing at 21 per cent over SPLY. Other Top 10 brands which showed a strong growth are Clavam (24 per cent), Monocef (29 per cent), Moxikind-CV (24 per cent) Azithral (33 per cent) and Mikacin (43per cent).

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Cardiac therapy continued to be the second largest therapy in IPM clocking a revenue of ` 1252 crores and a growth rate of 10 per cent on

SPLY. While the therapy grew in double digits, Top 2 molecules Rosuvastatin (6 per cent) and Atorvastatin (1 per cent) grew at a slower

rate. Only Amlodipine + Telmisartan (14 per cent) and Cilnidipine (22 per cent) were among top 10 molecules which showed growth in dou-

ble digits. While combinations showed a better growth of 12 per cent, plain molecules grew slightly slower at 8 per cent. Six of the Top 10 brands

MARKET showed double digit growth of which Brilinta (37 per cent) and Cilacar (31 per cent) grew the strongest. No 1 brand Rosuvas grew at 9 per cent whereas only one top 10 brand Nikoran (-12 per cent) showed a negative growth.

Gastro intestinal therapy continued to be the No 3 ranked therapy in IPM with a value of ` 1043 crores for the month with a growth of 8 per cent which was slower than the IPM. Eight of the top 10 molecules in the therapy registered a positive growth while Ranitidine Oral Solids (-9 per cent) and Omeprazole + Domperidome (-2 per cent) showing a de-growth. The largest molecule Pantoprazole + Domperidome clocked ` 65 crores for the month and showed a growth of 4 per cent. Bacillus Clausii continued to be the fastest growing among Top 25 molecules with a growth of 34 per cent for the month. All Top 10 brands except Zinetac (-21 per cent) and Pan-D (-2 per cent) showed a positive growth with the No 1 brand SpasmoProxyvon+ growing at 5 per cent. Top 10 brands to show a double digit growth were Rantac (18 per cent) and Duphalac (14 per cent) and Aciloc-RD (21 per cent).

Anti-diabetics maintained its fourth rank in the IPM and clocked a value of ` 974 crores and looks set to cross ` 1000crore mark soon. It recorded a growth of 12 per cent which was at par with the IPM and an improvement over the last few months. All the top 10

molecules grew positively and seven of them grew at double

digits.

Top Glimepiride +

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grew at 6 per cent whereas SGLT2 Inhibitors (65 per

cent) showed the fastest growth among top 10 molecules. In DPP4 inhibitors molecules like Metformin + Sitagliptin (23 per cent) and Metformin + Teneligliptin (69 per cent) grew strongly whereas Metformin + Vildagliptin (2 per cent) and Vildagliptin (-8 per cent) grew poorly. All top 10 brands grew positively with only Galvus Met (-4 per cent) showing degrowth. Other top 10 brands like Janumet (23 per cent), Lantus (29 per cent), Jalra-M (21 per cent) and Istamet (23 per cent) grew strongly.

Dermatology for the first time in many months lost the crown of fastest growing therapy in IPM as its growth of 14 per cent was slower than other acute therapies.

The therapy clocked ` 780 crores for the month. Six of the top 10 molecules grew in double digits while the top category Emollients Protectives are growing at 13 per cent for the month. Both antifungal molecules Itraconazole (46 per cent) and Luliconazole (113 per cent) continued their strong progression and drove the growth for the therapy while Clobetasole + Ofloxacin + Ornidazole + Terbinafine also showed a strong growth of 89 per cent. While two of the Top 10 brands Betnovate-C (4 per cent) and T-Bact (-13 per cent) registered negative growth, others like No 1 brand Panderm+ (109 per cent), Candiforce (21 per cent) and IT-Mac (29 per cent) record strong growths.

EVENT BRIEFS PHARMATECH EXPO 2018 & LABTECH EXPO 2018 Date: April 27-29, 2018 Venue: Parade Ground, Sector 17, Chandigarh Summary: PharmaTech Expo 2018 & LabTech Expo 2018 is an international exhibition on pharma machinery, lab, analytical, pharma for-

Contact details 701 - 702 Corporate House Nr Dinesh Hall,

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IPHEX 2018 Date: May 8-10, 2018 Venue: Pragati Maidan Summary: iPHEX 2018 will bring together the drugs,

pharmaceutical and healthcare industry – all under one roof. The event will be organised by Pharmexcil and supported by Ministry of Commerce and Industry, Department of Commerce, Government of India.

400 overseas buyers from focus areas are being invited to participate in

the exhibition.

Contact details Mumbai TV Industrial Estate, Unit No 211, 2nd Floor, 248-A, S K Ahire Marg, Worli, Mumbai – 400030 T: 91 22 24938750 F: 91 22 24938822

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cover )

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THE MAIN FOCUS

CELEBRATING WOMAN POWER Express Pharma shares the success story of some of the women leaders in pharma sector

By Swati Rana

he world has witnessed a significant change and attitudinal shift in society’s views about women’s equality and emancipation. In the early 80s, the work place was not equipped to assist the needs of a women, 90s saw a slight change and there was a noticeable change in the 21st century. Working in the pharma industry too wasn’t easy for women earlier as several factors, including local and federal laws made it difficult for them to work during certain hours. Today, though more women are joining the work force, as far as the pharma industry is concerned, certain challenges and concerns are still prevalent.

According to the consulting firm Mercer, women represents only 11 per cent of the work force as against 15 per cent of the general industry. It has also been observed that while there is not much of a gap between men and women at the entry level, the gender gap widens at the senior level.

According to The Color of White, an OPPI publication also points out that, currently, women workforce in pharma companies is less than 15 per cent. Comparatively, the average percentage of women in other industry sectors range from 15–35 per cent. It seems to be a global issue as well. A UNESCO report cited that women participation in STEM (science, technology, engineering and mathematics) field continues to be abysmally low all over the world. An Economic Forum Report reveals that India has only 14.3 per cent researchers who are women, dedicated to the field of science. The reason may be multifaceted but one glaring aspect is that parental expectations and societal norms too have often hampered the growth of women in these areas. Pharma sales is another area which has long been considered a male domain and has very few takers

T

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when it comes to women.

The number of women in leadership roles in pharma and biotech are fairly low as well. Despite global reports citing that richer gender diversity leads to better financial results, the percentage of women executive directors in the pharma sector stands at 7.69 per cent. The industry is witnessing a ‘funnel effect’: there is not much gender disparity at the entry level. But as the seniority level rises, the gender gap widens and there is an ever-dwindling pool of women as candidates for top positions. There is an almost dry leadership pipeline at the top.

We do find women at the entry and mid-levels, but the rates drop in the midmanagement levels.

In the biotech sector, it’s estimated that there are only seven to nine per cent women playing the role of chief executive. Interestingly, this gender imbalance is not unique to pharma or biotech companies as women hold a mere four per cent of CEO positions in the Fortune 500 companies survey.

However, despite many challenges, exemplary women hold the top positions in some of the largest pharma companies in India and globally. To name a few, GlaxoSmithKline’s CEO, Emma Walmsley and Mylan’s CEO, Heather Bresch helm their respective organisations globally, while in India, Dr Swati A Piramal, Vice Chairperson, Piramal Enterprises, Kiran Mazumdar Shaw, Chairman & MD, Biocon and Vinita Gupta, CEO, Lupin Pharmaceuticals are trendsetters, breaking through glass ceilings.

In observance of International Women’s Day, the current issue of Express Pharma features some exemplary women who have excelled and succeeded in various roles in the pharma sector.

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cover ) Dr Harvinder Popli shares her learnings and experiences from her journeyas an educationist and pharma technologist My story…

The initial years of my career I spent with academics as a faculty which helped to clear my concepts with exposure to international best universities in the UK for research as common wealth fellow and Canada during my doctorate research. I was fortunate that after starting my career in education, I could successfully shift to the industry and then back to academics. Such changes are hard to find in education. Working with one of the leading multinational global pharma companies of India with senior leadership team was quite a challenge but I was determined to convert this challenge into opportunity.

Working both in academics and industry has given me a complete perspective, helping me in my present journey. Women are resourceful, and able to succeed, despite many challenges. No one is an optimist all the time and to be successful, a business woman often needs to be a team player – or serve as merely an inspiration – not always insist on being in the lead. I always had an open mind and creative ways to utilise the strength of my team to achieve the goals .

My family played a very important role in my success. I was blessed to have my husband who shared my dreams and helped me overcome the challenges in taking care of children while I was either studying or travelling overseas for my work. Other important things which helped me to succeed was my attitude of not to quit till I succeed, being objective and most valuable skill of networking. The most important thing in networking is sincerity, building and sustaining trust.

To be successful, one needs to be adaptable and open to new ideas. Having access to resources increased my efficiency, knowledge and chances of succeeding.

Challenges for women leaders

PROF DR HARVINDER POPLI DEAN & PRINCIPAL CENTRE OF PHARMACEUTICAL SCIENCES, DELHI PHARMACEUTICAL SCIENCES AND RESEARCH UNIVERSITY, GOVT OF NCT, NEW DELHI

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Managing a career and family while maintaining sanity is not an easy task. Most of us believe that we can have it all, a fulfilling career, relationship and children. But that is not possible without family support. Working women have to simultaneously run their families and work and in this area

SUCCESS MANTRA ✦ Listen to the concerns of others, but instead of just giving up on an idea, reassess its value from others’point of view. Do not give up ✦ Focus on what you are good at and give your hundred per cent till you exceed ✦ Sincerity, hard work and building trusts are few mantras to be successful

traditional gender expectations still prevails.

Women experience even more demands on time, energy and resources and face gender discrimination in business and on the job. Even though more women hold higher degrees than men, they are still passed over for jobs that go to less-educated and less-qualified males, and they also receive less compensation than men for the same job. At the same time, nowadays women are more aware and there are equal opportunities for men and women to be a leader. Professionally, you face equal challenges.

How the government can help?

The government's initiatives in this direction can change the scenario. Preferential treatment to women in the first ten years of their career when they also have to take care of their family can make a huge difference to the women reaching the top. The government is taking a few initiatives to encourage, but some of the most effective tools in overcoming challenges that working women face include networking, finding a mentor and funding.

A few multinational companies reserve senior positions for women for gender equality, which can be promoted by the government. The government can support by setting up day care centres for working women so they can work peacefully, flexible timings and options to work from home wherever possible besides incentives so that women are encouraged to join back after maternity leave.

Nowadays there are equal opportunities for men and women to be a leader

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Kiran Mazumdar Shaw,Biocon’s leading lady shares her success mantras and details her inspirational growth story My Story…

When I started Biocon, I was 25 years old with no business experience and limited financial resources. In the 1970s, entrepreneurship was an unusual career choice for women, and biotech was unheard of as an industry sector. I was daring to start a business in a male-dominated society and that too in a sector that no one was familiar with.

Banks and financial institutions were reluctant to fund me and some even suggested that my father should be the guarantor for any loans. Professionals did not want to work for me as they felt that I could not provide them ‘job security’ being a woman.

Suppliers told me they were reluctant to give me credit because they did not have confidence in my business abilities.I was not one to give in easily and worked hard with a single-minded focus to create a business that would leverage science for the benefit of society through affordable innovation. As a pioneering biopharma enterprise, Biocon was among the first in India to invest in developing recombinant DNA and bio-processing technologies to deliver innovative and affordable biologic drugs.

We focussed relentlessly on chronic disease spaces marked by unmet needs. I am proud that today my company Biocon is considered to be among the world-beating innovators in biopharmaceuticals and one of the most recognised Indian names in the global biotechnology sector. We are now focussed on the mission of developing drugs that can be labelled 'blockbusters', not because they can earn a billion dollars but because they are affordable enough to benefit a billion patients!

Challenges for women leaders

KIRAN MAZUMDAR SHAW CHAIRMAN AND MANAGING DIRECTOR, BIOCON To subscribe: bpd.subscription@expressindia.com

Many women are forced to take career breaks post motherhood, which sometimes hamper their progress and hinders them from achieving success. Women also face gender disparity and are often passed over for promotions even when they put in equal or more effort and perform better than men at the workplace, which de-motivates them and leads many to quit their jobs.

We need to have a more enabling ecosystem which comprises the workplace, the home and society at large to check this kind of 'brain drain'.

Good childcare infrastructure at the workplace and a strong family support system can help women transition back to their jobs post maternity in a smooth manner. Corporates also need to ensure gender parity in pay and promotions.

SUCCESS MANTRA There are many more opportunities for a young woman who’s interested in a career in science today.

If you want to succeed in this field you have to be innovation led.You should pursue a pioneering spirit that more often than not separates leaders from the followers. Courage of your conviction and perseverance to overcome disappointments and failures are the hallmarks in this journey of endurance. My underlying belief is Persevere till you succeed. Failure is temporary but giving up is permanent! Believe in your goals and aspirations and attain them with a sense of purpose.

How can the government help?

According to Skill India Report, while industrywise hiring targets for women in pharma and healthcare sectors currently is about 39 per cent, the total employability of women is only about 28 per cent. Despite efforts of the government, under-representation of women in STEM remains a burning issue. While the Indian government has come up with programmes such as Udaan to enrich the teaching and learning of science and mathematics at the school level, more needs to be done to address unconscious biases and gender stereotypes that lead to lower participation and representation of women in STEM fields. It's also not going to be enough for the government to bring in policies, business leaders will also have to walk the talk and abandon their biases and preferences in recruitment. A survey of Fortune 500 companies indicates that companies with higher female boardroom representation outperformed on various financial parameters like return on sales (RoS) and return on investment (RoI). To have more women leaders in pharma, it is important to address gender diversity issue at the organisation level. Gender balance in leadership is possible by sensitising behaviour and taking concrete steps to build an organisation where there are forums for women, opportunities for networking and mentoring, talent management, and a flexible working environment. Also, organisations need to invest in innovative programmes that encourage women to take up higher learning and executive education, get opportunity to network, hear from role models and learn to upgrade and acquire skills that will help them grow as professionals.

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cover ) Dr Ranjana Pathak shares insights for women leaders in the making and urges them to meet challenges head on My Story…

My journey has been a roller coaster ride, filled with laughter and some tears. The challenges were numerous, since I started at the very bottom, this forces you to learn, understand the nuances of the job, the expectations of the organisation, and the regulators.

This job soon became a career and now a calling. I have always been driven, spent hours reading trade journals, studying books on key topics such as chromatography, the USP etc. By the way, the USP is a great book to learn from if you are in the lab. When I started my career, I was the only girl in the QC lab, it was daunting because I had zero experience, this was a challenge to overcome. For me it was a new country, working for the first time in my life, so I suppose the survival instinct kicked in. I have always been very focussed. I have the drive to be the best in what I do. These two traits have enabled me to be a perennial student, keeping me in the learning mode. I never liked the status quo and always opted for harder tasks, taught courses because it would force me to learn and be challenged by pharma executives. The need to excel has been with me literally all my life which drives me to take challenges head on.

In summary, it is my purpose, drive, doggedness, persistence and courage that have enabled me to overcome the numerous challenges that faced me and I know I am not alone! I have also been blessed with having a very supportive family, bosses and colleagues.

Challenges for women leaders

DR RANJANA PATHAK GLOBAL HEAD, QUALITY, CIPLA

20 EXPRESS PHARMA March 1-15, 2018

Time is the biggest challenge, the pharma industry is competitive and by nature, timeline bound. There is seldom tomorrow, everything seems to be needed yesterday, a very fast paced, exacting and demanding industry, full of challenges, some anticipated and others binding. For women, to play their classical roles in society and families becomes difficult, because of their innate nature.

Women from time immemorial have been jugglers, they must juggle the needs of their families, children, work, friends, communities etc…the list goes on and on.

Given that the number of hours is limited for all, women need to be able to prioritise the 'must dos', and let go of those tasks that cannot

SUCCESS MANTRA To my new comers and those that are stalwarts: Always do the right thing, be courageous, know your subject, believe in yourself, look at yourself in the mirror each morning and say—Wow, I am looking at a great piece of art that is going to make a huge difference today!!! If I can do it…You can do it better!!

be done and will not matter in the long run, 'take help' from family members, friends, neighbours to be able to juggle everything on their plate.

Creating a conducive growth environment The government can and should execute laws that are conducive for women to work, the organisations then must follow through to make the work place environment safe. School and universities should promote science and maths so children join science rather than hanker for business degrees alone, don’t get me wrong we need those as well but I think I see a tip towards business. If there is no product, there will be no business to manage. Today’s generation wants instant gratification, the millennials are different from the baby boomer generation, their needs and tolerances are not the same. Careers in disciplines other science seem to be more popular. The pharma industry needs sharp scientists, engineers, biologists, microbiologists, physicists, computer science etc. to ensure that new drugs/devices are developed, existing drugs are made more affordable, the quality is uncompromised. This is a daunting task where the government can help in ensuring the platforms exist. The government can do a lot to make this feasible for women/girls in urban and rural schools.

Need for regular campus placement There are more number of science graduates coming out of universities who want to join the pharma sector. However, due to lack of job opportunities they have to change their career goal. To address this, the pharma industry needs to be present in the campus to educate the graduates of tomorrow about the needs of humanity (need for medicines) and the need of society.

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Kanchan TK elaborates on the role of effective mentoring to create women leaders in the pharma industry My story…

I was fortunate to have mentors who encouraged and supported me in my journey to becoming a leader. But it didn’t come easy. Over the years there were situations where I faced gender discrimination, gender stereotypes and mansplaining. Those moments were frustrating but strangely motivating. I believe that women need to be vocal advocates of balanced leadership.

Women leaders can be created through active sponsorship and mentoring. We need ambassadors of our good work who will go out into the corporate world and speak for us. Women need to start networking more; here I don’t mean just random lunches and dinners. As a rule, it is important that we meet three new people everyday who can help us further our careers.

Challenges for women leaders The challenge is to overcome the mindset of a 'not ready' ecosystem. Over the last few years, corporations have just about begun to recognise the profitability of having diversity in their workplace. Work place policies are now being designed to nurture female talent: around maternity, remote working, gender sensitivity, dress codes and workplaces themselves are being redesigned. Then there is this issue of years of patriarchal systems even at corporations and how women never made it to the boardrooms or leadership, that’s an even larger issue as it’s around changing gender stereotypes.

The second challenge is the manner in which women relegate themselves to transactional roles as too much importance have been given to multi-tasking. Being courageous enough to ask for the roles that you want is also something women shy away from. Demanding the right pay for the job is yet another roadblock that women need to navigate.

KANCHANATK DIRECTOR GENERAL, ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA (OPPI) To subscribe: bpd.subscription@expressindia.com

SUCCESS MANTRA It’s humbling that women even consider me a role model. It’s a responsibility which I do not carry lightly.

Given that there are so few women role models in pharma, I would like to be resilient and succeed.

Never doubt yourself.As in the words of Sylvia Plath, “I took a deep breath and listened to the old brag of my heart. I am, I am, I am!”

How the government can help?

The government can play a pivotal role in creating the right incentives for having more women in science and by extension, in the pharma industry. Ideally, this would mean more jobs for women in leadership roles and otherwise.

A Skill India Report says that industry-wide, while the hiring targets for women was tentatively 38.67 per cent, the suitability and employability of women for particular roles was only 28.28 per cent. The government must address this gap in skill up gradation, and improved the curricula.

Another place to start is parliamentary representation of women. According to a report by Inter-Parliamentary Union and UN Women report, India stood 148th globally as far as representation of women in the executive and Parliament was concerned. Women constitute a dismal 11.8 per cent (64 MPs) of the 542 member Lok Sabha and 11 per cent (27) of the 245 member Rajya Sabha, in India. I feel under representation of women in the political arena also leads to under development of other related issues like education, health, and safety. Having a more balanced representation in the legislative would go a long way in paving the path for more women in the industry and foster gender diversity and inclusion.

The government can play a pivotal role in creating the right incentives for having more women in science and by extension, in the pharma industry EXPRESS PHARMA

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cover ) Aparna Thomas stresses on creating a level playing field for women in the pharma sector My story…

I moved to Mumbai from Vadodara in 1999 to work for a public relations consultancy, where I led several healthcare projects for our clients. Early exposure to assignments that required behaviour change gave the opportunity to home my talent, passion and professionalism. I realised that working in the healthcare sector is very fulfilling and hence, it helped build my commitment to patients and helping them manage their diseases better. I then moved to Pfizer and for the last 10 years, have been with Sanofi, working to improve diabetes management, support rare diseases, create awareness about the benefits of immunisation, etc. I’m happy to share that the culture at Sanofi is very supportive and encouraging, thus, easing my growth within the organisation and also, allowing me the opportunity to contribute to business and the community.

SUCCESS MANTRA If you’re passionate about excellence, then you will certainly enjoy what you do.Also, always encourage other women to explore their potential. Doing so will help build a culture where you and many other women can grow and over time, build a new era in the pharma industry.

decisions are made by women, there definitely needs to be a good representation of women at all levels within the healthcare industry. After all, since gender balance is a positive business growth driver, companies will gradually see the benefits, thus, no government incentive will be needed.

Gender neutral culture in organisation Challenges for women leaders For women, the complexity of simultaneously playing many roles is a major stumbling box. Yet, to be really successful, we must get better at asking for the help and support we need, and to prioritise, trust and delegate more.

The government’s role Given that health is an area where 80 per cent of

APARNATHOMAS SENIOR DIRECTOR - COMMUNICATIONS (SOUTH ASIA) & PUBLIC AFFAIRS (INDIA), SANOFI

22 EXPRESS PHARMA March 1-15, 2018

Gender balance is possible by sensitising behaviour and taking concrete steps to build organisations where there are forums for women, opportunities for networking and mentoring, talent management, and a flexible working environment. Women are not looking for favours, just a level playing field, and the single most powerful thing an organisation can do to promote more women leaders is to create a gender neutral culture.

The single most powerful thing an organisation can do to promote more women leaders is to create a gender neutral culture

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I N T E R V I E W

Not only in pharma, but in any field, today there exists equal opportunities for women Jyoti J Sardesai, Director, Goa FDA, the first woman to hold this post, speaks on her journey and the current scenario of pharma sector in Goa, in an interview with Swati Rana

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Brief us about your journey from drug inspector to the Director of Goa FDA? I am an alumnus of Goa College of Pharmacy. After graduating in Pharmacy from University of Bombay in 1984, I joined the pharma industry and after eight years of experience in public as well as private sector companies, I was selected by the State Public Service Commission for the post of drug inspector, and I joined Goa FDA in March 1992.

After 13 years, I received my first promotion as

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cover ) Assistant Drugs Controller in 2005. I then completed my Post Graduation in Pharma Sciences from Goa University in Pharmacology. In 2010, I became the Deputy Director of the Department and in December 2017, I was promoted as Director of Goa FDA. Concurrently, I have worked as a designated officer for the licensing of food establishments, and also held the positions of Public Information Officer, Public Grievances Officer, Chairperson of the screening committee for NSQ drugs and Chairperson of the Committee for sexual harassment etc. I have also served as the Nodal Officer for Goa State Litigation Policy, and Survey to detect the extent of Spurious and Sub standard Drugs, carried out by CDSCO. As the first woman director in Goa FDA, how do you see the current scenario of women leaders in pharma industry and what are the challenges you have faced?

Interestingly, I was the first woman drug inspector to join the Department in Goa. In fact, I was selected by State Commission for two more Gazetted Officer positions, namely, Junior Scientific Officer in FDA and Scientific Officer at Goa College of Pharmacy at the same time. It was my choice to be a drug inspector, when the number of women drug regulatory officers in our country was pretty low.

I am happy and proud to say that today, nearly 60 per cent of my drug and food regulatory officers in Goa are ladies.

As is generally the case, being the first woman officer in regulatory duties, there were certain challenges that came my way, especially working extra hours, late night inspections and raids, and the general attitude of the stakeholders towards a lady regulatory official. But I must mention here the support that

24 EXPRESS PHARMA March 1-15, 2018

I received from my colleagues and bosses, which encouraged me to do my duties diligently.

Today, we see many women occupying senior management positions, including that of CEOs, in India as well as the world pharma industry, and they are doing as well as their male counterparts. I am sure they must have faced multiple challenges along the way, in defeating the conventional notions. But yes, today the glass ceiling is indeed broken.

According to you, what are the major reasons for the lack of women leaders in the industry?

Not only in pharma, but in any field, today there exists equal opportunities for women.

Women are no less in qualifications, talent, intelligence, hard work and efficiency. According to me, in our Indian value system, for a woman, family requirements take priority over career requirements. Demands of the job such as late workings, travels, outdoor duties often clash with demands of family, including children. Here, positive attitude of the family members and their unstinted support matters above all else and plays a great motivating factor to the determination of working women.

Brief us on the issues faced by the pharma industry in Goa. Goa today is a preferred destination for pharma manufacturing , predominantly for exports.

We have about 70 manufacturing facilities, of MNCs as well as leading Indian companies, majority of them approved by international regulators viz.

US FDA, MHRA, MCC, TGA, ENVISA, and even Japan. The rest of the facilities are certified under WHO-GMP scheme. Some of the aspects that attract these manufacturers to our state are pollution free environment, English literate

workforce, availability of pharmacists, good connectivity by road, rail, sea as well as air, and encouraging government policies. Our department too, has over the years, played a positive role in facilitating the above, through a speedy and transparent functioning. In addition, good educational institutions, residential options and generally a good life also is a motivating factor for the senior management personnel to move to Goa. In addition, we have several blood banks as well as one public testing laboratory in Goa. Goa is one of the states with a high number of pharma plants. What are the problems faced by FDA in carrying inspection on a regular basis and does the state FDA has sufficient drug inspectors?

In spite of the above positive aspects, some of the major issues faced by the pharma industry in Goa are adequate supply of quality power and water. For power, our state is dependent on the national power grid and we do not have any power plants here for public supply. So, there are certain restrictions. But the situation has improved in the recent years. For water too, the work of laying new and bigger pipelines and of augmenting the supply is currently on.

In issues of manpower supply, we have two pharmacy colleges in Goa, where 120 graduates pass every year.

Additional qualified pharmacists are available from neighbouring states like Maharashtra, Karnataka, Odisha, AP etc, and so also other employees.

Goa FDA is engaged in regulating both, food and drug activities in the state. We have two distinct sections for each.

The Director of Goa FDA is also the Commissioner of Food Safety.

We presently have nine drugs inspectors, two technical officers, three

assistant drug controllers and two deputy directors. We are also equipped with a fully functional testing laboratory for food and drugs, in our own campus. It has Asst Chemists, chemists, Jr Scientific Officers and Sr Scientific Officers in the drug testing section. Yes, the current manpower is just sufficient for the existing pharma manufacturing as well as trading activities.

Goa being a smaller state, nothing is really that far, and moreover, our office is situated at a convenient and accessible location. The building is designed to be people friendly and our staff is trained to be responsive to the stakeholdersâ&#x20AC;&#x2122; needs.

Our drug inspectors carry out regular inspections, investigations, joint inspections with Central Drugs Regulatory Offers, participate as observers during overseas audits like US FDA, MHRA, ENVISA etc, and we have not experienced any serious problems in all these activities. The biggest contributor to this is the high level of regulatory and CGMP compliance by our manufacturers. Incidences of spurious and misbranded drugs are almost non-existent in Goa. Even the quantum of drugs not of standard quality is very small.

What initiatives have been taken by the state FDA to keep the drug inspectors update with the changes in regulations?

Our department has always believed in keeping our regulatory, technical and analytical staff updated with the latest changes, techniques etc, and our participation levels in the training sessions, workshops, seminars organised by CDSCO, NPPA, US FDA,WHO, IPC as well as FSSAI are very consistent and high. We have also provided conference hall and training facilities within our premises, which are used not only for our staff, but also for

training and awareness activities of our stakeholders.

How is the state addressing the issue of counterfeit of drugs?

As mentioned earlier, we have not experienced a single instance of manufacturing of counterfeit drugs in our state.

However, we have come across cases where counterfeit versions of the brands legally manufactured in Goa, were being manufactured elsewhere in the country and sold. Mostly, these have been popular brands with easy-toduplicate packing, like bottles or strips. We have actively conducted investigations, often in association with other state regulatory officials, and taken the process to its logical conclusion, including prosecutions.

Two of the major initiatives that we plan to undertake are upgradation of our testing facilities with the aim of achieving NABL accreditation of our Food and Drug Testing Laboratory and opening a branch office of our Department in South Goa District.

For the laboratory, we are in the process of recruitment additional staff and procurement of sophisticated instruments and for the South Goa office, the site has already been allocated by the government. If all goes well, we will have both these projects on stream shortly.

The current issue of Express Pharma is on Womenâ&#x20AC;&#x2122;s Day. Can you share a few inspiring words for women following your footsteps?

My humble message to fellow women would be simple and clear- give equal importance to career and family, work hard, keep yourself constantly updated in knowledge, techniques and regulations, keep high aim and work with determination to achieve it.

And one last thing, be strong and never ask for concessions based on gender. swati.rana@expressindia.com

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Express Healthcare and Bayer collaborate to raise awareness on women’s health Members of the medical fraternity, media professionals, social activists and representatives of the pharma industry come together to discuss and deliberate on measures to enhance women’s health and empower them to lead a better life Lakshmipriya Nair Mumbai

W

omen have come a long way. They have battled for their rights and proved their mettle, be it science, politics, sports, business, literature or art. Alas, their health, an important aspect, continues to be overlooked and neglected. Gender-based health disparities continue to exist and hamper women’s strides to progress.

Therefore, recognising the urgent need for renewed commitment towards women’s health, Express Healthcare and Bayer Zydus Pharma, came together to bring key stakeholders on a common platform to educate and inform about the advances in this sphere. At an event held at St Regis, Mumbai on February 20, 2018, eminent members of the medical fraternity, media professionals and representatives of pharma major, Bayer Zydus Pharma shared a stage to discuss and debate on the best strategies to inform and empower women to make the right health decisions.

Welcoming the esteemed guests and dignitaries, Viveka Roychowdhury, Editor, Express Healthcare set the context for further discussions and highlighted how vital it is to address inequities in women’s health. She urged the stakeholders to join hands to enable more funding, research and creation of effective policies and programmes to deal with women’s unique health needs. Stressing on the essentiality of making women’s health a major priority to ensure progress of the nation and the society, she also drew at-

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Mass media can play a crucial part in generating awareness and sensitising the society about women’s health and hygiene needs SPRUHA JOSHI Marathi film and theatre actress

Women living in slums face several health hazards. It is important to devise effective strategies and solutions for their better health SHUBHALAXMI PATWARDHAN Director, Niramaya Health Foundation

Our country is mired in outdated traditions and practices, be it about menstruation, pregnancy or contraception DR RISHMA PAI Consultant gynaecologist, Lilavati Hospital, Jaslok Hospital, and Every Woman Clinic

Timely and appropriate counselling for women of all ages is important to empower them to lead a healthy life DR NANDITA PALSHETKAR Infertility specialist, Lilavati Hospital and Fortis Group of Hospitals

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cover ) tention to the role of the media, as a watchdog, to help ensure higher visibility and understanding of this issue.

Next, Manoj Saxena, MD, Bayer Zydus Pharma took the stage to speak on Bayer’s work and offerings in women’s health.

He elaborated on the company’s contributions towards innovative contraception and gynaecological therapies. He assured that Bayer has pledged its allegiance towards the cause of improving women’s health, worldwide and in India. He also informed that it is investing significantly in research and product development to meet heretofore unmet needs in this sphere.

Renowned Marathi film and theatre actress, Spruha Joshi was the Chief Guest at the event.

As a modern woman who has donned several hats successfully, she gave a great perspective on the health needs of today’s women. She pointed out that despite being the custodians of their family’s health, women often tend to overlook their own well being which have severe and significant adverse effects later. Joshi also urged parents to empower their girl children with the right knowledge to help them make the right choices for their health and wellbeing throughout their life.

She cited the example of her parents’ role in making her a woman capable of making her own choices when it comes to her health and thanked them for their support.

She was also very emphatic that mass media can play a very crucial part in generating awareness and sensitising the society towards women’s health and hygiene needs. Yet, in her opinion, mass media hasn’t been optimally utilised to achieve this objective. To prove her point, she highlighted that it has taken the Indian film fraternity over 100 years of existence to make a movie like Padman, the recently released Askhay Kumar starrer which addresses menstruation and issues related to it.

An interesting panel discussion followed Joshi’s insightful address. An eminent panel com-

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Bayer’s presence in women’s health is 90 years old, since its research on a contraceptive pill MANOJ SAXENA MD, Bayer Zydus Pharma

dometriosis, delayed pregnancies due to late marriages etc.

She also informed that with advancements in healthcare, now women have various ways and means to make their pregnancies safer. She also recommended options such as freezing of their eggs and preserving them for a later stage in life, if women need to delay child-bearing. Dr Palshetkar also advocated timely and appropriate counselling for women of all ages to empower them to lead a healthy life.

Joshi recounted some harrowing real life experiences of dealing with abysmal sanitary conditions and unhygienic toi-

(L-R) Viveka Roychowdhury, Editor, Express Healthcare; Manoj Saxena, MD, Bayer Zydus Pharma; Shubhalaxmi Patwardhan, Director, Niramaya Health Foundation; Dr Rishma Pai, Consultant Gynaecologist, Lilavati Hospital, Jaslok Hospital, and Every Woman Clinic; Dr Nandita Palshetkar, Infertility specialist, Lilavati Hospital and Fortis Group of Hospitals and Spruha Joshi, Marathi film and theatre actress

prising Dr Rishma Pai, consultant gynaecologist at Lilavati Hospital, Jaslok Hospital, and Every Woman Clinic; Dr Nandita Palshetkar, infertility specialist associated with Lilavati Hospital and Fortis Group of Hospitals, Delhi; Spruha Joshi, Actress; Shubhalaxmi Patwardhan, Director, Niramaya Health Foundation and Manoj Saxena, MD, Bayer Zydus Pharma. The moderator, Viveka Roychowdhury, Editor, Express Healthcare, steered and veered the discussion through various pertinent aspects of women’s health.

The panelists touched upon women’s health problems ranging across all age groups across different strata of the society. Dr Pai spoke on how she encounters various young girls with health problems, often caused and aggravated due to ignorance about their bodily

processes and sexual health. She lamented that despite advancements in various areas, our country continues to be mired in outdated traditions, beliefs and practices, be it about menstruation, pregnancy or contraception. Citing examples, she pointed out that women are shunned during days of menstruation, many believe in mahurats for C-section deliveries and often become victims of STDs and unplanned pregnancies as religion prevents them from using contraception. She opines that these obsolete notions and ideas are very detrimental to women’s well-being.

Dr Palshetkar threw light on the various complexities in women health issues arising in these rapidly changing times.

She gave valuable insights on the different causes of infertility among women such as stressful lifestyles, diseases like en-

lets in the course of her career as an actress. She emphasised that hygiene and sanitation are major aspects of women’s health and urgent attention is needed towards these areas.

Patwardhan, as a social activist, drew a very realistic picture of the deplorable conditions of women living in the slums and the various health hazards faced by them. She pointed out that the health issues faced by these women have different causes from those faced by women living in better socio-economic conditions.

Therefore, the strategies and solutions to deal with them also need to be different. She said that when basic amenities are lacking, it is hard to educate and enforce other learnings. First and foremost, in the lower strata of the society, it is important to meet the basic needs of women such as daily nutrition, safe

drinking water and clean toilets.

She also spoke on the importance of imparting sex education to young girls in these areas as teen pregnancies, poor sexual health, unsafe abortions, high risk of sexual infections etc. are also challenges that need to be tackled. Patwardhan also informed about the various initiatives undertaken by the Niramaya Foundation to deal with these issues.

Saxena, as the only male member on the panel, spoke on how essential it is to sensitise men in the society to the health needs of women. He opined that men too will have to uphold and champion the cause of women’s health as it is directly proportional to a family’s health.

All the panelists were in complete accordance with these views. The moderator, adding her insights to these statements, said that behind every empowered woman there is an enlightened man.

As a representative of Bayer Zydus Pharma, Saxena reiterated once again that his company is fully empathetic to women’s health requirements and is in the pursuit of discovering and tailoring solutions to suit individual needs of women across all ages, geographies and socio-economic conditions.

The panelists were also unanimous in their opinion that sex education, timely counselling at educational institutes and workplaces on women’s health, encouraging women to go for regular health check-ups, instilling and adopting a scientific approach towards these issues are some very crucial measures to bring about significant improvements in this area.

They collectively promised to do their bit to ensure better health conditions for women and advised everyone to do the same by passing on the right message and spreading knowledge to ensure better outcomes.

The discussion ended on a hopeful note that in times to come, women will truly have the freedom and knowledge to take the right decisions for their good health and well being. lakshmipriya.nair@expressindia.com

MANAGEMENT INSIGHT

How 2018 will unfold?

Dr RB Smarta, MD, Interlink Marketing Consultancy, gives insights for each organisation to be agile and utilise their entrepreneurial management skills to leverage opportunities and achieve success

“M

arket and industry structures are quite brittle, one small scratch and they disintegrate… how abruptly Professor Peter Drucker has captured today’s situation of the pharmaceutical industry.”

Infact all of us know that disruptions and changing habits of patients, doctors, distributors, pharmacists have made the market structure so different that we don’t know how brittle it is.

Similarly, if we look at industry structure SMEs, MSMEs, big pharmaceutical companies as well as MNCs and international companies are getting structured towards different directions and even the competition is emerging from different medical systems, diagnostics and new entrants in pharma industry along with technological disruptions.

It has been always said that there is no single blueprint for success; the evolving landscape continues to offer plenty of opportunities and what you need to perceive it. As already stated, the above market structure is dynamic and provides major opportunities for innovation.

Each organisation has to be agile and utilise its entrepreneurial management skills with industry insights.

recognise the impact of these two major disrupts, which includes downward pressure on pricing.

Following are some major disruptions, which have lot of bearing on the position of pharmaceuticals in 2018. ◗ Demonetisation: Pharma executives are well aware of the disruptive potential and are experimenting with a wide range of digital initiatives. The Indian

superior insight and decision making, and transform business processes to provide realtime responsiveness. ◗ GST: An amalgamation of all the taxes into one uniform tax – GST, this will ease the way of doing business in the country, as well as minimise the cascading effects of manifold taxes.

This has encouraged the transparency in the processes, improvised the operational efficiency by rationalising the supply chain, and improved overall compliance. It also changed the habit of individuals to work on consumption pattern. ◗ De-branding: De-branding exercise has been happening in each country and it is a global phenomenon. It emerged into ‘Generics’. Now is the time to differentiate generics and science has to take a lead.

By promoting generic medicines drug consumption the government safeguards the health of its generic drug manufacturing industry—one of the largest suppliers of low-cost medicines in the world. The objective of Janaushadi Pariyojna is to make quality medicines available at affordable prices for all, particularly the poor and disadvantaged, so as to reduce out of pocket expenses in healthcare.

Eight disruptions and reforms The disruptions in my opinion are behavioural reforms leading to changing habits that impact the growth. The two major disruptions that vibrated India are demonetisation and implementation of GST in 2017. Pharma companies are starting to

economy begins to get integrated with the global economy and enters the digital era; changes are likely to take place in the business environment often described by the term VUCA (volatile, uncertain, complex and ambiguous). Main areas where digitisation will drive value for pharma companies, is from an ability to deliver more personalised patient care, engage more fully with physicians and patients, use data to drive

Various disruptions and their reforms

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◗ NITI Aayog decision on MCI: Niti Aayog has suggested a replacement of MCI with a National Medical Commission, which would encompass selected members through a transparent process. Niti Aayog’s draft legislation wants

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MANAGEMENT to change the education system by implementing entrance tests at start and exit phases of education, which will ensure the quality and quantity of doctors produced by the system. ◗ Seismic shifts: Three seismic shifts have occurred. The first shift is in the balance of power across the healthcare value chain and second is downward pressure on pricing. The government and insurers are taking centre stage, pressuring pharma companies to reduce prices and demonstrate greater value from their therapies.

And thirdly, a swing from treatment to prevention and cure, attracts new entrants in market. This shift is driven by three developments like groundbreaking new therapies, advancement in technology, traditional medicine usage, alternate medicines acceptance and consumerisation of health through increased access to data by patients. ◗ Advancement in technology: Product innovation and technology strategy is the essential link between development efforts and business strategy. Executive’s visibility to the pipeline of new product, technology, and platform projects enables strategic project selection, prioritisation, and spending decisions.

An active portfolio company is active in several therapeutic areas and is equipped to acquire and divest parts of its portfolio in a ‘Plug & Play’ fashion. ◗ Ground breaking new therapy: Ground breaking new therapies will lead to immersion of Niche specialists.

Even though the speciality therapies will increase share, mass therapies will remain important. Mass therapy consists of two opportunity areas. Major opportunity is seen in acute indications, which incorporate therapeutical areas for respiratory and gastro-intestinal.

This segment is increasingly being driven towards OTC because of patient awareness and propensity to self-medicate. The second opportunity lies with older therapies in chronic diseases like diabetes, hypertension. ◗ Move towards genetics application: These applications would take patients to go closer to individualised and personalised medications.

Changing track: Treatment to prevention Lifestyle diseases such as obesity, diabetes, cardiovascular problems, CNS disorders and other chronic diseases, etc. are on hike and are on target by the pharma industry. Well, this is due to the unhealthy habits, increasing stress; increase in adoption of western lifestyle chronic diseases will be focussed. But

that doesn’t grab our opportunity to target acute diseases as due to poor hygiene and sanitation the acute diseases will also continue.

The industry previously was physician centered and now the trend is more towards patient centricity. They are keen to gain knowledge and literate themselves by healthy lifestyle tips. Various new technological applications are hovering over the market that tracks the health and helps in prevention, early diagnosis of diseases.

Also, today patients are becoming more aware of Pathy agnostic, thus alternative medical remedies business that focus on healing the internal root cause of disease are growing. An Ayurveda which includes treatment like Panchakarma (multi-day rejuvenation program) is highly personalised treatment, and focusses on preventive care rather than cure, and treat the body and mind holistically.

Ten emerging growth drivers ◗ Patient centricity: The shift is observed from clinician-centric to patientcentric that will enable the IT to play a significant role. Significant transformation is observed in healthcare system, the role is extending from treatment to prevention and remote patient monitoring, maintaining health by means of fitness and adoption of healthier lifestyle.

Organisations need to design a new approach based on an understanding of patients’ experiences and how they make decisions. Most pharma marketers are familiar with the concept of conducting market research to create a ‘sales funnel’ as a guide for marketing programmes, where patients move in stages from product awareness to product purchase. Often, these use a linear or sequential logic to represent patient behaviour.

Combination of methods, tools, and techniques helps to encounter the principle of a patient-centric focus. The advantage of techniques will encourage patients to seek out information about their health on touch of finger, make appropriate decisions about their healthcare; they will proactively try to manage their health, and tend to experience better health outcomes. ◗ Quality culture and compliance Quality control to quality assurance to quality delivery has been the progression of quality changes along with different quality management tools where different models are available. Knowing Indian characteristics and intelligence along with reverse engineering and reverse pharmacology expertise, I do not find any specific difficulty in maintaining high quality unless there are any

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MANAGEMENT managerial disruptions.

However, this being a major driver in providing relief to the patient as well as opening different horizons, we need to look at quality culture and compliance. It has been observed that cultural aspects of maintaining quality and compliance could be issue which is perhaps diluting quality.

It’s an internal issue and yet a very important growth driver and hence each company should focus on this driver. ◗ Technology-driven growth: As technology is being utilised at R&D, product development level, you will find technology could be used to get into more niche therapies. Mass therapies can be provided at logistics as well as at target customer level and patient level with wide use of apps and technology-driven information, awareness and provide enough influence to educate patients to derive value from the new therapies. ◗ Active portfolio: An active portfolio company is active in various therapeutic areas. As the number of blockbuster drugs protected by patents continues to decrease, the management of product lifecycle in pharma is going to be critical.

The present Indian medical devices industry landscape is primarily 75 per cent import driven. Along with the challenges due to inadequate quality standards setting, time delays and other related hassles, new product development has become a hindrance making the domestic medical devices business challenging for the industry. ◗ Rural markets: Besides urban markets where major consumption of pharma industry is observed and rural markets perhaps do not add that value but are capable of doing that.

New disruption of increasing Janaushadi pariyojna and Patanjali outlets as well as promotion of generics, it’s important that through this new outlets as well as technology, rural market can be captured. There is also a possibility that tele diagnostics, telemedicine, along with e-commerce would perhaps accelerate the pace of cap-

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towards digitisation; GST had improved compliance and transparency in processes. Debranding has paved the way to prosperity of generics through Janaushadi Pariyojna and government is taking effort to provide affordable healthcare services. Also, we are best fit in providing tertiary care management and we encompass progress in medical tourism.

The growth of the company will be dependent on the demand generation efficiency of the company and their product portfolio and pricing. Enabled IT services will empower R&D, hospitals, organisations, e-Health, to become patient centric.

What industry should choose?

Ten growth drivers of pharma industry

turing from rural markets. ◗ Integrated healthcare: The Indian Government is currently in the throes to reform the healthcare system. After years of under-funding, most public health facilities provide only basic care. Moreover, three quarters of medical facilities are located in urban areas, leaving the majority of rural workers without access to hospitals or pharmacies.

Many of the poor rely exclusively on alternative forms of treatment such as ayurvedic medicine, Unani and acupuncture. The initiative taken by the government lead to implementation of new policy to build more hospitals, boost local access to healthcare and improve the quality of medical training. ◗ Rx to OTC: The market is experiencing consolidation and expansion through products or merging of new division for nutraceuticals and creating footprint in OTX & OTC markets.

The ` 3600-crore acquisition of Unichem’s domestic business

by Torrent Pharma has brought the charm back into India pharma’s merger and acquisition. ◗ Consolidation and expansion: Many times growth is

stunted due to growth of few leverage brand and as a new product pipeline is drying up it becomes difficult to launch new products and make them successful in short time. Perhaps at that time buying over few brands or consolidating with other organisations with merger or acquisition becomes a good choice and driver. Similarly, it’s possible to expand through new therapy area and create another division to focus and grow. This expansion can be also way forward for growth. ◗ International markets: International markets are always value creators for industry and now that ROW market (Rest of the World market) such as Asian countries, and other emerging ROW markets can provide an impetus for international market growth. Having an experience of the US, the UK, and other countries emerging markets would also provide good growth factors. ◗ Mindset of management: It’s a mindset of senior management in every company to look at affordability, accessibility, acceptability, of change which are obvious in environment and align themselves in such a way that depending on the product mix, company creates mix in

any of the three major factors essential for India.

How 2018 would look After demonetisation and implementation of GST, consumers have changed their habits in several ways. The consumers are more conscious about their consumption and transactions are digitalised maintaining the transparency in the overall process. The result of this entire economy will be now driven by consumption and potential, the individual growth of an organisation will depend on the capability of organisation, demand generation, efficiency, product portfolio and pricing of the products. It is estimated that the growth will be affected and will account for 7.5 per cent to 8 per cent. Looking at demographics, in future our youngster will add substantial value to growth by 1-1.5 per cent. Hence, the industry may grow by 9.5 per cent to 10 per cent.

The young generations who are in right demographic dividend zone are adding value to the growth of industry. Adapting to the new technologies and digitisation processes is the new trend. The major disruptions or reforms in any country lead to change in habits. In case of demonetisation and GST, people have altered their way

If the industry is to improve its performance, provide services at affordable costs, serve the emerging markets more effectively and move along with the transition from producing medicines to managing outcomes – as demands of healthcare payers, providers and patients are increasing. At times it will have to collaborate with other organisations, both inside and outside the sector.

In addition, there is a clear economic rationale for greater collaboration. Several nonpharma companies have already entered the scenario.

Vodafone has, for example, joined forces with Spanish telemedicine provider Medicronic Salud and device manufacturer Aerotel Medical Systems to offer a wireless home monitoring service. As the healthcare landscape changes and scientific expertise becomes less important than the ability to manage networks, the scope for competition from new entrants will increase.

References ◗ Pharma 2020: Challenging business models ◗ Large merger and acquisitions back in Indian pharma ◗ India Pharma Summit 2014-15, Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry ◗ An analysis of generic medicines in India, Gudipati Rajendera Kumar

MANAGEMENT REPORTS

Need for supportive care in oncology will increase during the next decade Chemotherapy will remain the backbone of cancer therapy for the foreseeable future THE NEED for effective supportive care in oncology will increase in the next decade as patients continue to live longer and cancer progresses to become more like a chronic disease. This includes the need for chemotherapy-related conditions, as chemotherapy will remain the backbone of cancer therapy for the foreseeable future, observes GlobalData.

The company’s latest report: ‘PharmaFocus: Supportive Care in Oncology’ states that while there are blockbuster treatments in the areas of chemotherapy-induced neutropenia (CIN), chemotherapyinduced anemia (CIA), and bone metastases, other areas of supportive care in oncology are not as strong. The chemotherapy-induced nausea and vomiting (CINV) features a wide array of treatment options but no blockbusters, while oral mucositis has a much smaller treatment portfolio and cancer cachexia currently has no approved treatments.

Supportive care increases patient quality of life, improves their chances of completing treatment, can reduce costs for healthcare institutions, and is fundamentally necessary given that patients are now living longer and cancer is becoming more like a chronic disease.

While the level of need varies greatly between them, unmet needs still remain in each indication. The greatest level of unmet need is present in cancer cachexia – an indication for which there are no products approved by the FDA, European Medicines Agency, or Japan’s Ministry of Health, Labour and Welfare. Thus, the main, over-arching unmet need in this indication is simply for any therapy to treat it.

EP News Bureau

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MANAGEMENT

Late-stage CKD-induced comorbidity therapeutics market to reach $10.5 bn by 2026 One of the most prominent clinical issues surrounding the HPT, HP, and HK space is patient compliance with current therapy options SALES FOR chronic kidney disease (CKD)-induced hyperparathyroidism (HPT), hyperphosphatemia (HP), and hyperkalemia (HK) therapeutics were estimated to be $4.2 billion across the seven major markets (7MM) in 2016. This is expected to grow to $10.5 billion in 2026, at a Compound Annual Growth Rate (CAGR) of 9.5 per cent, according to GlobalData, a leading data and analytics company.

The company’s report: ‘OpportunityAnalyzer: Late – Stage Chronic Kidney Disease’ states that over the forecast period, the most prominent wave of sales increases will come from the launch of new HK agents and the calcimimetic, Parsabiv, which will counteract the loss of market exclusivity of its in-house predecessor, Sensipar (cinacalcet).

One of the most prominent clinical issues surrounding the HPT, HP, and HK space is patient compliance with current therapy options. This is observed across the board for all available therapeutic classes, whether in the form of the pill burden of the phosphate and potassium binders, gastrointestinal (GI) toxicity in the calcimimetics, or the life-long administration of vitamin D sterols.

Jesus Cuaron, Healthcare Analyst, GlobalData, comments, “Although patient compliance is an area with the highest unmet needs, the present trend in corporate strategy highlights the fact that recent advancements have been suboptimal, as they involve nonnovel approaches to improve current treatment options by developing ‘me-too’ drugs instead of transformative therapies.”

Resins have been considered the standard of care for treating non-emergency acute

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One of the most prominent clinical issues surrounding the HPT, HP, and HK space is patient compliance with current therapy options and chronic CKD-induced HK patients following diet and lifestyle modifications and/or lowering potassium intake.

However, resins have an unpredictable onset of action,

adverse GI effects, bad taste, and a sodium or calcium presence, which have made nephrologists uneasy when prescribing these treatments in heart failure and CKD

patients. As such, the arrival of new HK agents with preferable clinical profiles has been long awaited.

Cuaron continues, “Currently, there is only one novel HK agent on the market, Vifor’s Veltassa, which launched in the US in 2016. Key opinion leaders agree that Veltassa has more robust positive clinical data and preferable patient compliance for patients suffering CKD-induced HK compared to outcomes seen with resin treatment.”

Amgen’s Parsabiv is a sec-

ond-generation IV calcimimetic for the treatment of dialysis-dependent HPT patients.

Parsabiv is vying for a robust launch into the HPT market.

Parsabiv has been evaluated in several Phase III studies, and has shown superior results in a head-to-head study against the first-in-class calcimimetic, cinacalcet, as well as encouraging results from placebo-controlled studies, all of which instil physician confidence in Parsabiv’s capability to treat HPT dialysis patients.

EP News Bureau

MANAGEMENT

Majority of oncology clinical trials in China failed to meet enrolment targets Enrolment efficiencies of 324 clinical trials were conducted between January 1, 2012 and December 31, 2017 THE MAJORITY of oncology clinical trials in China that had a start date between January 1, 2012 and December 31, 2017 failed to meet the planned enrolment targets, according to GlobalData.

The company identified and analysed enrolment efficiencies of 324 clinical trials during the period and found that on average the enrolment efficiency values of clinical trials across all phases, excluding Phases I/II, fell below 100 per cent.

Although Phase II clinical trials recruited fewer subjects on average (93.1 subjects) relative to Phase II/III

(343.3 subjects) and Phase III (513.5 subjects), the greatest discrepancies between planned targets and actual numbers of enrolled subjects was observed in this phase, which had average enrolment efficiencies of 87.8 per cent.

Furthermore, Phase I oncology clinical trials typically failed to meet planned enrolment targets despite enrolling an average of 22.3 subjects in these trials.

Combined Phase I/II clinical trials, which typically integrate efficacy and safety purposes into dose-finding objectives, enjoyed the highest enrolment efficiencies and ex-

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ceeded planned enrolment targets with an average enrolment efficiency of 103.5 per cent.

Due to low numbers of clinical trials with enrolment data available, Phase IV clinical trials were not included in these analyses. The top drugs investigated in these clinical trials include atezolizumab with seven clinical trials, Hutchison Medi Pharmaâ&#x20AC;&#x2122;s fruquintinib with seven clinical trials, Hutchison Medi Pharmaâ&#x20AC;&#x2122;s sulfatinib with six clinical trials, ibrutinib with five clinical trials, and olaparib with five clinical trials.

EP News Bureau

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RESEARCH UPDATES

Lilly breast cancer drug wins expanded US approval The expanded approval was based on a late-stage study in which Verzenio taken twice a day with either anastrozole or letrozole significantly delayed disease progression

U

S regulators have approved expanded use of Eli Lilly and Co’s Verzenio breast cancer drug as an initial treatment for certain women with advanced or metastatic disease, a decision that should boost sales of the medicine, the company said.

The Food and Drug Administration approved the drug in combination with an aromatase inhibitor in previously untreated postmenopausal women with HR positive,

HER2-negative advanced breast cancer. Verzenio was originally approved last September in combination with AstraZeneca’s Faslodex (fulvestrant) once the disease had progressed following endocrine therapy.

The Lilly oral drug competes with Pfizer’s Ibrance and Kisqali from Novartis.

The expanded approval was based on a late-stage study in which Verzenio, known chemically as abemaciclib, taken

twice a day with either anastrozole or letrozole significantly delayed disease progression compared with a placebo and one of the aromatase inhibitors.

“Today’s news represents continued progress towards helping more people living with this devastating disease,” Marc Hurlbert, chairman of the Metastatic Breast Cancer Alliance, said in a statement.

Reuters

Less-invasive heart valve replacement tied to better quality of life The results offer fresh evidence that transcatheter aortic valve replacement can help ease symptoms like shortness of breath and fatigue that limit the ability to handle physical exertion PEOPLE WHO get minimally-invasive surgery to replace damaged heart valves have an easier time completing daily tasks and a better quality of life after the procedure, a research review suggests.

The analysis focussed on people with what’s known as aortic stenosis, which occurs when the large blood vessels leading away from the heart narrow, forcing it to work much harder to pump blood.

The condition tends to develop with age and can lead to chest pain, shortness of breath, fatigue and heart failure.

Patients in the study had minimally-invasive surgery that fixes the problem by inserting a replacement valve to send blood around the damaged valve while leaving it in place. This procedure, known

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as a transcatheter aortic valve replacement, is done by threading a catheter to the heart through a small incision in the chest or from the large artery in the groin - it doesn’t require cutting open the chest.

Afterward, patients could walk significantly further in six-minute walking tests used to assess their functional capacity. On average, they added almost 42 meters (138 feet) to their performance before surgery.

In addition, patients reported clinically meaningful improvements in their quality of life and their ability to complete daily tasks after surgery.

The results offer fresh evidence that transcatheter aortic valve replacement can help ease symptoms like shortness of breath and fatigue that limit the ability to handle

physical exertion, said Dr David Cohen, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri.

“These symptoms lead to reduced functional capacity (inability to perform physical exertion) and also impact a patient’s overall sense of wellbeing and quality of life,” Cohen, who wasn’t involved in the study, said by email.

“By replacing the diseased aortic valve, transcatheter aortic valve replacement (and surgical valve replacement) reverses these effects and generally allows the patient to return to his or her ‘normal’ quality of life - limited only by the impact of other conditions that the patient may have,” Cohen said.

Overall, the current analysis included 2,775 patients

from a total of 20 previously published studies on outcomes for this type of surgery.

Participants were 82 years old, on average, and they were typically considered high-risk surgical patients due to either advanced age or other medical issues.

The smaller studies in the analysis ranged in size from 36 to 484 patients, and most of them followed patients for as long as six to 12 months after surgery.

One limitation of the current analysis is that many of these smaller studies were not controlled experiments designed to prove whether or how transcatheter aortic valve replacement might improve quality of life, lead study author Nicola Straiton of the University of Sydney and colleagues note in Age and Ageing. Straiton didn’t respond to

emails seeking comment.

People who don’t get this type of minimally invasive surgery may instead get a more invasive procedure that involves surgeons cutting open the chest to repair a damaged valve.

Surgeons may also perform what’s known as angioplasty, which uses a catheter to insert a tiny balloon and inflate it to open the valve; sometimes surgeons will also insert a stent, or tiny wire mesh cage, to keep the artery propped open.

Results of the current study reaffirm that a minimally-invasive procedure can be a viable option, even for elderly people who are highrisk surgical patients, said Dr Samir Kapadia, a cardiovascular medicine researcher at the Cleveland Clinic in Ohio.

Reuters

Study finds new superbug typhoid strain behind Pakistan outbreak The researcher found the bacterial strain causing the outbreak is now resistant to five antibiotics in total, more than seen in any outbreak before AN OUTBREAK of typhoid fever in Pakistan is being caused by an extensively drug resistant ‘superbug’ strain, a sign that treatment options for the bacterial disease are running out, scientists said on Tuesday.

Researchers from Britain’s Wellcome Sanger Institute who analysed the genetics of the typhoid strain found it had mutated and acquired an extra piece of DNA to become resistant to multiple antibiotics.

An outbreak of drug-resistant typhoid that began in Hyderabad in Pakistan in November 2016 is still spreading, according to experts from Aga Khan University who worked with the Sanger team.

Official data on case numbers and deaths are not available, but local Pakistan media reports say health authorities detected more than 800 cases of drug-resistant typhoid in Hyderabad alone in a 10-month period between 2016 and 2017.

The researcher found the bacterial strain causing the outbreak is now resistant to five antibiotics in total, more than seen in any outbreak before.

“This is the first time we have seen an outbreak of extensively drug-resistant typhoid,” said Elizabeth Klemm, who co-led the analysis work at the Sanger Institute. “This outbreak was caused by a multidrug-resistant strain that had gone a step further and acquired an extra piece of DNA encoding additional genes for antibiotic resistance.”

Typhoid is a highly contagious infection caused by the Salmonella enterica serovar Typhi bacteria. It is contracted by consuming contaminated foods or drinks and symptoms include nausea, fever, abdominal pain and pink spots on the chest. Untreated, it can be fatal.

Scientists at Aga Khan University in Pakistan anxious to find ways to tackle an ongoing outbreak there contacted the Sanger in the spring of 2017 and

asked scientists there to genetically analyse samples.

The team found it was being caused by a strain known as H58, which is already known to be linked to drug-resistant cases. Looking further, they found this H58 strain had gained an extra strand of bacterial DNA – a plasmid – that encoded for additional antibiotic resistance genes. The study’s results were published in the scientific journal mBio. Charlie Weller, head of vaccines at Britain’s Wellcome Trust global health charity, said the findings were a clear warning that “treatment options for typhoid are running out” and focussing on prevention was now vital.

A new vaccine against typhoid was approved last month by the World Health Organization and the GAVI global vaccine alliance said last year it had earmarked $85 million to help support the introduction of typhoid vaccines in poor countries.

Previous research by Sanger scientists published in 2015 found that the H58 strain of typhoid first emerged in South Asia 25 to 30 years ago. It initially took hold in Asia and Africa before spreading around the world, becoming the dominant strain by 2015.

Reuters

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PHARMA ALLY / PACKAGING SPECIAL I N T E R V I E W

‘The SIES SOP/PTC has a long association with the pharma industry’ P V Narayanan, Chairman, SIES School of Packaging/ Packaging Technology Centre, in an interaction with Usha Sharma, talks about the journey of SIES SOP/PTC institute and how it is catering to the pharma industry with its courses Being the chairman of SIES SOP/PTC institute, what are your responsibilities and how do you execute them?

Established in 2001, the SIES School of Packaging has made considerable strides and earned a reputation of premier centre for training and education, packaging design and development, laboratory services besides a resource for promotion and information on various aspects related to the field of packaging. Expansion and strengthening of the activities and addressing to new potential activities, as well as creating a stronger industry – institution relationship would be the key goal. The task is being achieved through enrolling more and more industry members, organising and conducting industryoriented programmes, identifying and initiating R&D projects with other educational research bodies with active support and participation of the government and industries are being vigorously followed.

Strengthening of the laboratory infrastructure with testing and quality control equipment with state-of-the-art inputs are aimed to expand the laboratory services besides bringing in packaging and packaging related industries. Towards promoting goodness of packaging, it is proposed to work together with similar organisations and promote exhibitions and conferences/seminars with leading packaging exhibition partners/associates for international and national events. Promotional events include Star Awards for

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excellence in packaging, besides undertaking R&D activities either on its own or with industries or other educational and R&D institutions. Significant importance will continue to develop qualified packaging professionals to bridge a long felt gap in the industry.

Progress have been made to affiliate with overseas packaging institutions, with student and faculty programmes, joint research and academic qualifications.

The SIES School of Packaging/Packaging Technology Centre (SIES SOP/PTC), the apex body of SIES has initiated the Corporate Industry Advisory Body. Give us an update on the developments and the key activities.

The prime objective is to create an industry body and conferment of the ‘Fellowship of the SIES SOP/PTC’ with a view to extensively and actively involve a cross section of the industry representing packaging media, ancillaries, packaging machinery and systems. The presence and support of such leading industries would help to streamline the resources and facilities besides identifying other inputs needed towards the activities and services extended by the SIES SOP/PTC. Contribution from the industry veterans with extensive knowledge and experience also help us to continuously review and update our educational curriculum and identifying specialist faculty and industry

visits, which in turn helps the student community. Their help and assistance also facilitate the students in their group projects and inculcates a higher confidence level. Industry acceptance of the students for industrial training and internship adds considerable value in the quality upgradation of the students. They also provide references who the SIES SOP/PTC could reach out in respect of all activities.

The prime objective is to create an industry body and conferment of the ‘Fellowship of the SIES SOP/PTC’ with a view to extensively and actively involve a cross section of the industries representing packaging media and systems

What challenges do the Indian pharma industry face in the packaging sector? Can it be addressed by introducing new courses or training? Which courses do SIES SOP/PTC offer in pharma packaging and how many batches are over so far?

The SIES SOP/PTC has a long association with the pharma industry and its facilities are extensively used by them. These primarily include the laboratory services, training, education, package design and development. The centre also has the privilege of mutual NDA for the services rendered. Some of these also actively participate in promotional events like awards and recognition for excellence in packaging. Specific sponsorship given for best student in ‘Pharma Packaging’ underlines their closeness and contribution. The laboratory services used on a regular basis is indeed noteworthy. The centre also has expertise from the pharma sector. It would be of interest to add that with the close association of the packaging materials, packaging machinery and significant

ancillaries besides leading pharma groups, the SIES SOP/PTC has announced a two-day orientation programme on ‘Packaging of Pharma Products’, which is scheduled to be held at the auditorium of SIES SOP/PTC from March 13-14, 2018.

Deliberations are aimed to address the niche areas which the pharma sector needs to update and upgrade. The sector needs regular interaction to bridge the gap.

Regulatory measures, standardisation, quality assessment parameters, selection of right material, right process, adoption of new materials and systems are few of the areas which needs attention. Development of application oriented with corresponding specification details is necessary which would ease the procurement and acceptance/rejection criteria. Establishment of quality system, trained manpower and corresponding infrastructure is of extreme importance and should be a given a priority. The SIES SOP/PTC, in this context organises short and long-term programmes besides hands on training in laboratories on quality inspection/testing of packaging materials and packages and performance evaluation of packages. It is of equal interest to learn that the pharma sector, year over year, has been extending their internship training to SIES SOP/PTC students and on a regular basis absorbs the SIES SOP/PTC qualified candidates as part of their packaging team.

The next endeavour of SIES

Establishment of quality system, trained manpower and corresponding infrastructure is of extreme importance and should be a given a priority SOP/PTC will be to identify and address specific areas covering either product groupwise or packaging wise. Such interlogue is envisaged to cater better services that would be more in depth and beneficial. The SIES SOP/PTC also has now extended its arm to this industry through its packaging audit and design and development services.

How many students have received placements?

A reference has already been made to the co-working of SIES SOP/PTC. Herein, the information desired to be shared is the packaging professional and career development particularly the two-year year Post Graduate Course on ‘Packaging Science and Technology’ introduced in the year 2001. Over the 16 years, a total of 500 students have post graduated from the SIES SOP/PTC. Whereas a handful have moved out of the country for furthering their academic or better placed jobs – majority are with the industries within the country and most of them have moved the ladder to hold enviable positions and industries of a cross section by nature viz package converters, package users, packaging machinery besides ancillary sectors.

Their areas of operation also are spread over quality control, production, R&D, sales/marketing/ business development etc. The placement is thus very encouraging.

Our endeavour is to strengthen the infrastructure and activities. Update and upgrade the educational programmes with more and more specialisation as well as associate with overseas reputed educational universities. Currently, we are in association with the Rutgers and Cal Poly University, the US. We also have a similar student exchange programme with the GIPT in Mumbai. More are being planned. Simultaneous to this, the SIES SOP/PTC also is on a progressive path with the expansion of the laboratory and technical services to help the industry in their quality and best package requirements. The distance education and part time one year duration course have reached out to

more and more people. Product and industry-oriented orientation programmes will be streamlined more to cover different packaging and user sector. Yet another important goal is to introduce a graduate technology employment oriented course of three years duration and mid-term two to three month duration programme for working industry and academic faculty members. Dialogues are already in progress with industry associations outside Mumbai to extend the distance education programmes. A specific area related to shop floor personnel training to generate technicians – at operator levels, is also being looked into.

How many industry associates have partnered with SIES SOP/PTC and what role are they playing?

The SIES SOP/PTC has the pleasure of being associated with a large number of industry bodies that include: Flexible and folding cartons, packaging machinery, labels, and flexible intermediate bulk containers, besides working closely with exhibition organisations. Currently the centre is working with three exhibition organisers and propose to be with yet another packaging related association.

Whereas the role of SIES SOP/PTC would be administration, promotion, publications, representations and technical, the inputs from the associations would help to strengthen the infrastructure, expansion and contribution to various activities.

Tell us the future plans of the institute for this year.

The SIES SOP/PTC is in a positive growth mode. Expansion of infrastructure, promotion of its facilities and activities, newer publications more association and affiliation with domestic and overseas associations/industry bodies, development of more packaging professionals, continuation of recognition and awards for excellence for innovation, R&D projects, would be the areas where the immediate future action plans would be augmented.

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PHARMA ALLY / PACKAGING SPECIAL I N T E R V I E W

‘Counterfeiting has become the st crime of the 21 century’ Arun Agarwal, VP, ASPA, Deputy Director (Asia Pacific), International Hologram Manufacturers Association (IHMA), CEO, Kantas Track Pack India, shares details of 2nd Authentication Forum 2018, Leadership Summit on Anti-Counterfeiting and Brand Protection and the way forward to curb counterfeiting in pharma, in an exclusive interaction with Swati Rana

We are trying to help business leaders in fighting fakes and therefore, we have tried to design The Authentication Forum 2018 programme as an interactive forum

38 EXPRESS PHARMA March 1-15, 2018

It is the 2nd Authentication Forum 2018, Leadership Summit on AntiCounterfeiting and Brand Protection. What is the theme of the event this year and how is it different from the earlier edition?

The summit’s focus is to enable key decision makers at government, industry, consumer level to gain firsthand knowledge of anticounterfeiting technologies and solutions to fight against fakes. Today, having an effective anti-counterfeiting and brand protection strategy is no longer an option but an essential part of any business strategy.

We are trying to help business leaders in fighting fakes and therefore, we have tried to design The Authentication Forum 2018 programme as an interactive forum. With more than 15 presentations, including focussing on anticounterfeiting needs and advances in India, case studies from brand owners, there will be live sessions on counterfeiting real time experience and branding.

Apart from these, there will be three panel discussions on government roles and responsibilities, consumer protection awareness, future of anti-counterfeiting technologies such as blockchain, micro-optics, artificial intelligence, serialisation. In the end, there will be a big debate: an interactive townhall session

on who is going to take the lead against fighting fakes.

The Authentication Forum 2018 is going to be bigger and better and we are overwhelmed and thankful to our partners and associate including Ernst&Young, International Pharmaceutical Excipients Council of India (IPEC), Health Food and Dietary Supplements Association, FICCI CASCADE, Indian Beverage Association, Crop Life India, Pesticides Manufacturers Association of India, IHMA (UK), Centre for AntiCounterfeiting and Product Protection (USA), etc.

Counterfeiting is a global problem and many industries are affected by it.

Which industries will ASPA’s Authentication Forum 2018, Leadership Summit on AntiCounterfeiting and Brand Protection focus on?

Counterfeiting has become the crime of the 21st century. It is now a global menace, affecting almost all sectors, heavily bleeding the global economy. The problem is severe in many key sectors perhaps, the most affected are pharma, pesticides, FMCG, Automotive components. We plan on covering the issues affecting all these sectors and others in The Authentication Forum.

The pharma industry faces a lots of problems due to counterfeiting. How will this

event help the pharma industry in addressing the issue?

Many countries have regulations requiring serialisation which needs to be addressed by brand owners, e.g. India, the US, EU, Turkey and Russia. As the global pharma industry is moving towards a serialised world, the programme will help in evaluating all the available options required to ensure regulatory compliance, protecting supply chain and keep track of their products.

We have designed our programme in a such a manner that it will help delegates in understanding the entire eco-systems indepth. Secondly, ISO is going to publish new standards on tamper verification features for medicinal product packaging. Our members and expert speakers can help delegates in understanding all these requirements.

Tell us about the session related to counterfeiting in the pharma industry.

We have a panel discussion on government roles, responsibilities and action towards consumer protection and in that we had invited pharma policy representatives from the government to speak. Further, there are case studies from pharma companies such as Mylan Laboratories, explaining the brand owner’s perspective. There will be also presentation on current and

PHARMA ALLY / PACKAGING SPECIAL upcoming authentication technologies such as blockchain's role in packaging, artificial intelligence, NFC and others.

Tell us about the number participation and confirmed speakers from the pharma sector We are targeting approximately 200 delegates from across the sectors.

Express Pharma congratulates ASPA for completing 20 years in Authentication industry, can you tell us how you are helping the pharma industry. What are the solutions you provide?

Thanks for your wishes. Our 20th year celebration marks our commitments and presence for our industry and hence make us one of the oldest and leading associations in the anticounterfeiting industry, across the world. As an association, we are actively working with various trade bodies in raising awareness towards fighting fakes and adoption of authentication

from adulteration or replacement. An intact antitampering feature is the consumersâ&#x20AC;&#x2122; assurance that the contents are genuine and not tampered or adulterated.

Many countries have regulations requiring serialisation which needs to be addressed by brand owners, e.g. India, the US, EU, Turkey and Russia solutions. Some of our recent initiatives are as follows: Exhibition: We are exhibiting at various pharma related exhibitions to create awareness. Recently, we exhibited in Pharma Pro & Pack held in September 2017 at Hyderabad.

Brand Protection Awareness Workshop: Last year, we announced to conduct series of ASPA workshops for brand owners, government authorities and industry professional involved in brand protection, revenue protection, supply chain management, regulatory affairs and product packaging.

We conducted two workshops in Indore and Hyderabad which are pharma manufacturing hubs. We would like to do similar more in this upcoming year. The aim

is to generate awareness amongst stakeholders for need of fighting counterfeiting especially in sectors such as healthcare, automotive components, FMCG, pesticides, excise revenue, government document protection and others.

On the other hand, we are actively in communication with all the major industry association and trying to build zero tolerance environment against counterfeiting.

Currently, we are have received active support from various association included, FICCI CASCADE, ASSOCHAM, CII, IPEC India, HADSA, ACMA, SIAM, IBA, IHMA, Counterfeit Intelligence Bureau (CIB), Indian Institute of Packaging etc.

Our member companies are already providing all kinds

of anti-counterfeiting, brand protection and regulatory serialisation solutions. Today, there are various authentication technologies available in the market, which cover three main aspects: i) Anti-Counterfeiting ii) Anti-Tampering iii) Track and Trace Anti-counterfeiting: Anticounterfeiting technologies are extremely difficult to be replicated. Consequently, they help in identifying a genuine product. Based on the authentication requirements, such technologies may consist of overt, covert and forensic features, or a mix thereof.

Anti-tampering: Such solutions are found more in the food and pharma industries, where there is a need to protect a product

Track and Trace: Track and trace technologies use mass serialisation to provide a unique identity to each SKU. The IT technology then allows to keep a watch on each SKU through customised software that allow an authorised user to track the movement of this SKU across the entire supply chain. Depending upon the authorisation level, each user may also be able to access additional information pertaining to the product such as manufacturing date and factory, expiry date, the market such SKU is meant for etc.

Our members can provide all these technologies which can further be customised according to customer requirement. It is always recommended to adopt combination of physical and digital technologies. swati.rana@expressindia.com

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PHARMA ALLY / PACKAGING SPECIAL

The importance of designing smart integrated drug delivery systems Alagu Subramaniam, MD, India, West Pharmaceutical Services, gives an insight how pharma companies are turning to innovative integrated drug delivery systems to make self-administration a less painful and more convenient process FOR MANY patients, being diagnosed with a chronic condition means the beginning of a journey of lifelong care. This can be an especially difficult concept to process for patients with conditions such as rheumatoid arthritis or haemophilia, which may require regular administration of injectable medicines. While adjusting to their new normal, many patients are also seeking freedom from frequent doctors’ visits, opting instead to self-administer many critical medications at home, when possible.

In-home self-administration of injectable medicines presents an opportunity to improve the overall patient experience.

It also adds an additional layer to the challenge of patient compliance with prescribed treatment regimens. To help address this challenge many pharmaceutical companies are turning to innovative integrated drug delivery systems to make self-administration a less painful and more convenient process.

When injectable delivery systems are intuitive and efficient, they stand a better chance of helping patients stick with their treatment protocol because the impact on daily routines lessens. Conversely, drug delivery systems deemed inconvenient, intimidating or complicated can negatively affect a patient’s emotional attitude and motivation to sustain adherent behavior.

Putting patients first in delivery system design No matter what type of delivery system is selected for a particular injectable drug product, there are several elements that must be carefully considered early in the design process.

First and foremost is ensuring

40 EXPRESS PHARMA March 1-15, 2018

that a patient safely receives the proper dose of a prescribed medication. In past years, if a delivery system failed or was used incorrectly, patient error was most often the culprit. Now, the industry is rethinking that stance, and the priority is engineering improved usability into the integrated drug delivery system to help enable patients to achieve better outcomes. In order to design a drug delivery system that meets the needs of both the drug and the patient, the pharma manufacturer and its packaging and delivery system partner must carefully consider the interface between the drug, container, delivery system and patient.

Understanding patient needs informs usability Effective drug therapy requires more than simply having an effective molecule. It involves the combination of a safe, effective drug within a suitable container and/or delivery system, as well as an understanding of patient needs as they relate to administration. Drug manufacturers should take into account four main facets of this integrated drug delivery approach that, when planned early in the development process with a packaging and delivery system partner and executed successfully, may lead to better outcomes: ◗ Primary Container Format – The selection of a drug’s primary container throughout its lifecycle is an important consideration for drug efficacy and stability. Vials may be necessary for initial use during the drug development stages, but a syringe or cartridge system may provide a desirable solution for the patient when the medicine reaches the market.

Custom containment systems may also help to differentiate

tems should be designed in a way that encourages patients to want to use them. This starts from a thorough understanding of patient needs, including the fact that these needs may change during their treatment journey. Human factors analysis may be helpful here and can yield significant insight into patient behaviors, motivations and needs.

Developing smart delivery systems

the product, and should be considered early in the development process. ◗ Drug/Container Compatibility – Hand-in-hand with the type of primary container is making sure the container material can be safely and effectively paired with the injectable drug product. Is the elastomeric material compatible with the drug? What are the levels of extractables and leachables? Will a barrier film or coating be required for the elastomer? Choosing the proper container material can help prevent chemical incompatibility issues that could impact a drug’s purity, stability or efficacy. ◗ Container/Delivery System Interface – Once the primary container system has been selected, efforts must be made to ensure that it works with the delivery system. If the interface between the primary container and the delivery system is not effectively understood, the performance of the combined system may suffer. ◗ Patient Interaction – Simply designing a drug delivery system that patients can use is no longer sufficient. Delivery sys-

Technology is a ubiquitous part of our culture, and drug delivery systems are following this trend. Far removed from a vial and syringe, today’s advanced drug delivery systems are complex pieces of technology that can incorporate innovative and intuitive features that can make it easier for patients to self-administer critical medications.

Pharma companies are beginning to embrace ‘smart’ self-administration systems with electronics to deliver doses at specific intervals and connectivity that allows patients and providers to track adherence via smartphone apps.

However, this shift has created an interesting challenge: while self-administration technology grows more complex, it must easily integrate into a patient’s life. Drug delivery system manufacturers must ensure a number of qualities are present to bring value to patients. Key to this mission is creating technology that patients want to use by providing drug delivery systems that are: ◗ Less painful: Many drug delivery partners are developing self-administration systems that minimise discomfort. For example, using a large-volume injector can help to address the issue of discomfort during selfadministration, as they can

mitigate perceived pain with lower flow rates (higher flow rates are often associated with pain). ◗ Easy to use: Regardless of how innovative a delivery system is, it must be simple enough for anyone to use successfully.

Arthritis patients, for example, may have limited dexterity, which inhibits their ability to use the delivery system.

Through rounds of patient testing, manufacturers can ensure the platform is easy for patients to use.

When delivery systems are intuitive and efficient, they reduce the impact on patients’ daily lives, increasing the potential for optimum adherence which, in turn, delivers the kind of platform pharma partners need to market their drug.

Partnering for patients Patients travel a long road with a chronic condition. Pharma and delivery systems manufacturers must begin product development with that in mind, and create systems and options that will help patients comply with their prescribed treatment regimens throughout their course of care.

To best create patient-centric systems, pharma manufacturers should seek packaging and delivery system partners that can apply proprietary technologies, manufacturing excellence and patient understanding to their drug products and the products’ delivery and administration systems. Such partnerships will help drug marketers offer successful integrated solutions, benefitting manufacturers, clinicians and patients alike, while helping to improve patient compliance and outcomes. Because after all, isn’t that the shared goal of everyone involved?

PHARMA ALLY / PACKAGING SPECIAL

Provide enhanced security Chandan Pat, Business Development Manager, Essentra, says that the key to implementation of a successful serialisation system is information management and the control of data integrit IN JUST over one year’s time, the EU Falsified Medicines Directive (FMD) has come into effect. The new legislation will apply to a number of medicinal products for human use and will consist of two key elements of safety feature; first, track and trace serialisation solutions and secondly, tamper verification solutions.

This legislation supports efforts to counter the rising issue of falsified medicines. As the illicit trade is becoming ever more sophisticated, the risk of these fake products reaching patients increases and can be extremely dangerous. Counterfeiters in some parts of Asia have been known to pay patients leaving pharmacies to obtain their genuine packaging in order to then fill them with false products.

As a leading global provider of healthcare packaging and authentication solutions, Essentra advocates the implementation of multiple measures to provide enhanced security, including serialisation, tamper verification and authentication solutions.

The FMD states that health-

care packaging must be a ‘unique identifier’ – which is most often done via serialisation; the system of tracking, tracing and verifying products via unique identification codes.

These codes reveal the complete history of a drug, and take the form of a linear barcode, 2D barcode or a combination of numbers. The code will express key information about the drug contained in the box, allowing for the confirmation of the authenticity of the medicine and help to ensure that patients take the correct drugs.

However, there are still a number of challenges for pharmaceuticals to overcome in order to implement an efficient serialisation system. Firstly, a uniform mechanism must be put in place that meets the requirements at each level of the supply chain. This may require existing suppliers within the supply chain to invest in new IT systems, databases and business structures, which can be both expensive and administratively challenging. In addition, the creation of the required serial codes themselves is costly,

particularly when additional elements are included. The more complex the structure of the serial codes, the more difficult standardisation will be across all companies within the supply chain.

With so many different codes and suppliers to manage, Essentra believes that the key to the implementation of a successful serialisation system is information management and the control of data integrity.

The process of track and trace will mean that every point within the manufacturing chain will have to carry out a ‘stopcheck’, resulting in the collection of a large amount of data.

Each individual unit will have a

unique identification code and, once printed, this code must be recorded and tracked through the drug’s journey from supplier to consumer. The monitoring and organisation of this vast amount of information can be demanding, so companies and governments must work together to create an effective data management system.

In addition to the unique identifier, the FMD also states that packaging should also contain an ‘anti-tampering device’.

These devices are vital as they instantly allow the consumer to identify if the product they are about to use has been previously opened or interfered with, providing a first layer of security. Some examples of these solutions could be a label that is irreversible after opening, a label that leaves a void message or a carton that has glued locks.

Additionally, authentication features can provide a further layer of protection. They are often classed into three categories; overt, covert and forensic. Overt technologies enable instant authentication through visual inspection, such as holo-

graphic devices and colour-shift inks. Covert solutions - for example, microtext and microscopic tagging - rely on technologies such as infra-red and ultra-violet inks, and are difficult to detect without specialist equipment. Finally, forensic features, which include molecular markers and biological tracers, offer a further layer of authentication and can only be identified with laboratory equipment.

It is therefore clear that pharmaceutical companies and governments must act now to protect consumers from the threat of counterfeiters. With just a year until the FMD deadline, many companies are either at implementation stage or have already created new security and serialisation systems in-house. Meanwhile, those companies with hand-packed goods are tending to outsource to specialist secondary packaging companies, such as Essentra. Though introducing these solutions may be costly, the benefits to patients will be significant – and ultimately, that is who the pharma industry aims to protect.

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

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Email your contribution to: The Editor, Express Pharma, Business Publications Division,

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Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

EXPRESS PHARMA

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PHARMA ALLY / PACKAGING SPECIAL VENDOR NEWS

Waters launches BioResolve RP mAb Polyphenyl 450 angstrom 2.7 micron solid core Columns Users of BioResolve brand columns will receive application-focussed standards, templated methods, and an enhanced level of applications support WATERS CORPORATION has introduced BioResolve RP mAb Polyphenyl 450 angstrom 2.7 micron solid core Columns intended for the reversedphase analysis of intact or subunit-digested monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) using LC-UV and LCMS. In addition to getting performance-driven columns, users of BioResolve brand columns will receive application-focussed standards, templated methods, and an enhanced level of applications support to help ensure that they can consistently and reliably perform state-of-the-art bioseparations.

“A segment of the scientist community regards mAb and ADC separations as overly complex. The causes of their

frustrations are many and they include poor data quality, degradation of the target mAbs, poor recovery, excessive carry over and erratic results due to column-to-column irreproducibility. To address these issues, we tasked our research scientists to engineer a column that would raise the bar for separation performance and take the hassle out of the measurement process,” said Dr Erin

Chambers, VP, Chemistry, Waters Corporation. “Our ultimate goal is to enable biopharmaceutical scientists to generate consistent results that meet international regulatory requirements to confirm product efficacy and safety.”

Jacquelynn Smith, a member of Pfizer’s Analytical Research and Development Department, St Louis, Missouri who has evaluated the BioRe-

solve RP mAb Polyphenyl Column, said, “The newly introduced BioResolve RP mAb Polyphenyl wider pore column provides superior recovery, separation and resolution of therapeutic monoclonal antibody (mAb) subunits and domains, as compared to other RP C4 columns on the market.

This resulted in higher quality product profiles for mAbs and antibody drug conjugates, especially when hydrophobic subunits and domains were encountered. The BioResolve RP mAb Polyphenyl column addresses the key challenges of mAb and ADC subunit/domain analysis, helps toward rightfirst time analyses, and will be a valuable addition to our characterisation toolbox.”

Her poster, High Resolution Chromatography – Mass Spectrometry with a Novel Phenyl

RPLC Column for Heightened Characterization of Hydrophobic Monoclonal Antibodies and Antibody Drug Conjugates, was presented at the 22nd Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (WCBP) in Washington, DC. With the introduction of BioResolve RP mAb Polyphenyl Columns, Waters continues its commitment to the biopharmaceutical industry by meeting the needs of analytical scientists and lab managers across the discovery, development and manufacturing pipeline.

The new BioResolve RP mAb Polyphenyl Columns are now available worldwide from Waters.

EP News Bureau

4th Annual ‘Data Integrity, Reliability and Quality Metrics Workshop’to be held in Hyderabad and Mumbai The workshop by UBM India will enhance knowledge and upgrade skills to address the DI issues CPHI CONFERENCES, a division of UBM India, will organise 4th Annual ‘Data Integrity, Reliability and Quality Metrics Workshop’ scheduled on March 6 -7, 2018 in Hyderabad and from March 8-9, 2018, in Mumbai.

Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. Company Quality Management Systems are being scrutinised as to

42 EXPRESS PHARMA March 1-15, 2018

how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured. The FDA is now including recommendations for recipients to obtain 3rd party assistance when addressing DI issues.

Indicators of potential DI issues are an unreasonably low number of deviations, OOS incidents and EM excursions.

Regulatory non-compliance

is always a serious area of concern for the Indian pharma sector. With 13 warning letters being issued in FY 2015 and nine warning letters in FY 2016, DI still continues to be a severe problem to be tackled.

The workshop by UBM India will enhance knowledge and upgrade skills to address the DI issues.

Key topics of the conference include ◗ Data integrity

◆ Setting the scene ◆ Beyond the lab ◆ DI Training and the behav-

◆ Data Integrity questions as a

ioural elements

robust DI programme

◗ Investigations of Deviations, OOS, market complaints, audit findings arriving at the root cause & CAPA

◗ Group Exercises ◆ Analysis of an FDA Warning Letter ◆ Assessing a System for Data Integrity ◆ Implementing and running a robust DI programme ◆ Cultural Excellence

◗ Reviewing, Identifying, Archiving, Retrieval of the Laboratory or Shop Floor data – A.L.C.O.A ◗ Case Studies

part of an inspection ◆ Implementing and running a

EP News Bureau

PHARMA ALLY / PACKAGING SPECIAL

OPTEL Group acquires GeoTraceability The acquisition will allow OPTEL to close its end-to-end traceability loop, by completing its offer with the first link in the supply chain OPTEL GROUP, a leading global provider of traceability systems for diverse industries, namely, pharmaceuticals and medical devices, has recently acquired GeoTraceability. Consisting of two entities, one in Canada and the other in the UK, GeoTraceability develops advanced information systems combining traceability and geomatics technologies to support the inclusion of smallholder producers of commodities and raw materials into complex supply chains.

The acquisition of GeoTraceability enables OPTEL to close its end-to-end traceabil-

ity loop, by completing its offer with the first link in the supply chain; i.e., raw materials and resource extraction. OPTEL’s current expertise already covers most other aspects of the supply chain, such as manufacturing, distribution, consumption, and waste tracking. The addition of GeoTraceability’s technologies to OPTEL’s portfolio makes the company truly unique, as it is the only one in the world enabling end-to-end traceability.

This new acquisition also facilitates OPTEL’s entry into several other markets such as the agri-food and natural re-

sources industries. “Supported by increasing demand, geotraceability for raw materials is now a well-known concept throughout the world,” says Pierre Courtemanche, President, GeoTraceability. “Our solutions are currently used in 17 countries, mainly for cocoa, coffee, fruit, nuts, vegetables, cotton, palm oil as well as minerals, and our database contains information on more than 250,000 small-scale producers in Asia, Africa and South America,” adds Courtemanche.

By providing information on raw material producers at the start of complex supply chains,

investors, companies, and consumers can make more informed decisions regarding their investments, suppliers and product purchases. This new ability is directly related to OPTEL’s mission, as end-toend traceability is the key to a sustainable economy.

“Our plan consists in optimising supply chains to increase performance. Our customers, initially manufacturers, will now be able to benefit from unprecedented visibility over the origin of the raw materials that they transform,” states Louis Roy, President, OPTEL GROUP. “In addition to increas-

ing their operational efficiency and quality control, end-to-end traceability helps create a sustainable economy in the long term; this means respecting the environment as well as the availability of natural resources, concludes Roy. Thanks to technologies such as artificial intelligence and blockchain in particular, which ensures the security of the tracking process, OPTEL’s solutions will allow customers to increase productivity, reduce waste, cut distribution costs, control carbon emissions and even increase brand equity.

EP News Bureau

LANXESS demonstrates its commitment for quality education Continues its association with Teach For India LANXESS INDIA, a subsidiary of leading global speciality chemicals company LANXESS, has continued its association with Teach For India, which promotes the need for quality education throughout the country. The company has committed a sum of € 75000 (approx. ` 53 lakhs) per year for corporate social responsibility projects in India as part of its pledged five-year commitment to support the not-for-profit organisation’s efforts towards providing quality education to under-privileged children. LANXESS relationships with Teach for India will continue to prosper as LANXESS always look forward to extend its supports towards health and education.

Dr Jacques Perez, MD and Country Representative, LANXESS India recently handed over the cheque to Dimple Gujral, Chief Financial Officer, Teach For India (TFI) at LANXESS House in Thane.

LANXESS has been contributing to TFI since 2010, starting with a sum of € 50,000 per year.

LANXESS has supported over 15 TFI fellows (trained teachers on a two-year full time paid commitment) and over 675 students directly so far.

This contribution works as a support for the fellows who volunteer to teach the kids at the municipal schools since they generally have given up their jobs to fulfill these social com-

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mitments.

Speaking on this occasion, Dr Perez said, “At LANXESS, we are dedicated towards making a better tomorrow through partnering with NGOs like Teach For India in order to provide quality education. Good education is one of the most important needs that children have in their growing years

that helps shape their future. It is our collective social responsibility to ensure that, students are able to attend their school regularly and attain good standard of education.”

On behalf of TFI, Gujral said, “We are thankful to LANXESS for their continued support and encouragement in our earnest endeavour of im-

proving children’s lives through education. Our fellows are striving every day to bring out the best in every child and hand holding them on the path to a bright future. The support from corporates like LANXESS gives us confidence to sail forward in this journey.”

LANXESS believes in empowering education and has taken many initiatives in India, in the areas of education, skills training and preserving cultural heritage. LANXESS has previously contributed to various NGOs, technical institutions and schools to support education in every region that it operates in.

Teach for India is a nationwide NGO, that aims to eliminate inequity in education in India. Through its Fellowship programme, TFI recruits qualified college graduates and working professionals to serve as full-time teachers in low-income schools for two years. Fellows work to bridge the educational gaps that their students face, by using innovative methods in classroom.

EP News Bureau

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PHARMA ALLY / PACKAGING SPECIAL PRODUCT

Gandhi rolling shutters — Quality engineered GANDHI AUTOMATIONS, India’s number one entrance automation and loading bay equipment company, is the only manufacturer of rolling shutters certified to ISO 9001 - 2008 quality management system.

This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically advanced machinery to offer to the customer a wellengineered product. Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters. The research and development team with its extensive know-how and experience are able to produce specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations’ manufacturing process right through installation to after sales service.

Gandhi rolling shutters are ideal for situations where side room is at a premium and security is required. The rolling shutters require very little headroom above the structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. Gandhi rolling shutters are fabricated of interlocking galvanised insulated and non-insulated, stainless steel, patented aluminum or polycarbonate profiles and patented MS rolling grills.

Each of the rolling shutters is designed to the clients specifications conforming to IS 6248 and solidly constructed to promote trouble-free operation and long life.

Gandhi rolling shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300 (200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in http://www.geapl.co.in/rollingshutters.html

44 EXPRESS PHARMA March 1-15, 2018

PHARMA ALLY / PACKAGING SPECIAL TECHNICAL REPORT

Technologies for tabletting effervescent products Romaco Kilian provides the perfect solution for compressing effervescent formulations with maximum efficiency. An insight by Peter Heyn, Technical Marketing, Romaco Kilian TABLETTING effervescent products makes many complex demands. Yet with the right technology, these tablets, too, can be processed rapidly and safely as required for the respective product. Romaco Kilian has the perfect solution for compressing effervescent formulations with maximum efficiency. â&#x20AC;Śbecause it fizzes. Children are particularly fond of effervescent products for this reason. The beverage and confectionery industries accordingly offer an enormous variety. Yet the pharmaceutical industry also provides numerous products as effervescent tablets, for example pain relievers, cough syrups or medications for the gastrointestinal tract. A broad array of nutraceuticals are likewise available, often in several different flavours. The administration of water-soluble drugs is especially recommended for children, the elderly or patients with swallowing difficulties or a sensitive stomach. The range of pharma dosage forms which can be purchased today is very wide and effervescent tablets are fundamental.

Tablets with complex demands Effervescent tablets may have many benefits for the consumers to whom they are administered, but manufacturing and processing these hygroscopic products inevitably imposes complex demands. Effervescent tablets react extremely sensitively with air, light and moisture by nature.

Many of the active pharmaceutical ingredients (APIs) and vitamins processed in effervescent formulations are easily affected by heat. Effervescent tablets moreover tend to be friable and break. All these factors must be considered when

tabletting effervescent powders. The Romaco Kilian KTP 590X tablet press is tailor made for this kind of specification.

Hygienic design of the tablet presses in the Romaco Kilian KTP X series

Gentle compression Effervescent tablets are naturally prone to unwanted air pockets and capping, which is why the tabletting process takes place in three steps. The Kilian KTP 590X single-sided rotary press is consequently equipped with three separate compression stations. The first compression roller simply tamps the powder. Next, the tablets are pre-compressed while in the third step they are converted into finished products in the main compression unit. The use of Kilian 28/41 tooling simultaneously extends the dwell time, meaning harder tablets can be made because there is more time overall for deaeration. This stops the tablets from bursting later.

Smoother than ever Effervescent powders are hygroscopic with very poor flow properties. The fill shoes and paddles of the tablet press

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Brake magnets eliminate frictional heat

must therefore be designed to enable them to be filled efficiently and distributed uniformly in the die. The powder can also be lubricated with magnesium stearate to pre-

vent the product from sticking to the tooling. An external lubricant supply system sprays the punch tips and the die walls during the production process. This has the

advantage that the lubricant no longer has to be mixed into the product beforehand. Much less material is required for external lubrication. Harder tablets can be achieved as a

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PHARMA ALLY / PACKAGING SPECIAL result and the overall quality of the product is improved.

What’s more, external lubrication protects both the product and the machine by reducing the tablet ejection force. Consumers thank the manufacturer for this at the latest when they take the tablets. Effervescent tablets which are lubricated by an external system have a smoother surface, contain less magnesium stearate and are dissolved in water without leaving a grease film.

In short, Kilian’s hygiene concept ensures reliable processes and reduces the risk of cross-contamination to a minimum.

Safe processing Once the effervescent tablets have been compressed, they must be further processed in line with the product requirements. Owing to their chemical and physical properties, effervescents are not stored in a buffer container but transferred directly to the downstream packaging machines. A special transfer station developed by Romaco conveys the fragile tablets from the press to the primary packaging unit.

The tablets are fed from the scraper of the press directly to a Kilian conveyor belt running at high speed. Tailbacks of tablets at the press discharge are prevented by the acceleration, so that the products are removed and separated gently.

This enables selective sampling before the tablets are dis-

Cool machines Extremely low temperatures are essential in order to process temperature sensitive medications. The process temperature of the tablet presses in Romaco Kilian’s KTP X series is therefore kept at a constant level below 30° celsius.

To reduce heat input, the compression rollers were fitted with smooth-running bearings and the gear of the fill shoe mounted externally. A special cooling ring, situated underneath the die-table, acts as a thermal barrier. The temperature in the service area is additionally lowered by the efficient cooling of the torque drive. The brake magnets also play a crucial role here by eliminating frictional heat and protecting the material. There is hence no need to install an additional cooling unit when tabletting temperature sensitive products. Not surprisingly, ‘cool’ is one of the three hallmarks of the Kilian KTP series.

Swing-out die-table

If effervescent tablets are to be manufactured efficiently, it is vital to optimise the retooling and cleaning times. The number of product-contacted format parts in the tablet presses has been systematically reduced by Kilian for this purpose

Fast off the mark If effervescent tablets are to be manufactured efficiently, it is vital to optimise the retooling and cleaning times. The number of product-contacted format parts in the tablet presses has been systematically reduced by Kilian for this purpose. Furthermore, the dietable, tablet chute and fill shoe can be swung right out for easy access to all components. Format changes can be completed without any additional tools.

At the same time, the start-up dosing control based on the filling shortens the run-in times and avoids material loss. The OEE (overall equipment effectiveness) of the tablet press

46 EXPRESS PHARMA March 1-15, 2018

Romaco Kilian KTP 590X single-sided rotary press for tableting effervescent products

can be significantly improved under these conditions. Depending on the formulation, the Kilian KTP 590X achieves an output of up to 290,000 effervescent tablets an hour while with mono or bi-layer formats, the single-sided rotary press manages a maximum hourly output of 511,200 tablets.

Clean performance Manufacturing effervescent tablets is an extremely dusty affair. A hygienic design is all the more important in order to keep unwanted dust formation in check. The compaction, retooling and service areas of the KTP 590X are strictly separated for precisely this reason. This prevents tablet dust

from entering the machine compartment or, in the opposite direction, machine oil from contaminating the product. The patented punch bellows surround the upper and lower punches and protect the tablets from impairments in the form of black spots. The closed system, made from elastic synthetic material, is ventilated by means of holes in the die-table; it is affordable to purchase and inexpensive to maintain. The press’ fill shoe and tablet chute are fully washable and thus easy to clean. The concentration of particles in the production environment is greatly reduced by the dust-tight tablet chute.

tributed by a rotary table to the conveyor belt of the primary packaging machine.

On their way to this machine they pass via two more stations for dust aspiration and breakage elimination. Effervescent tablets are normally packed either in strips or in tubes. The Romaco Siebler brand includes both heat-sealing machines and tube fillers.

Together with the Kilian presses, these two product lines form a functional unit for manufacturing and packaging effervescent tablets. Romaco’s effervescents portfolio is optimally complemented by Promatic cartoners and case packers.

PHARMA ALLY / PACKAGING SPECIAL VALUE ADD

Labindia dissolution system integrates with 21 CFR PART11 compliant software Sushil Bapat, Vice President International Business, Labindia Analytical Instruments, gives an insight on effective CFR which ensures that companies and organisations implement good business practices

E-signature

COMPUTERISED systems are widely used in the pharmaceutical industry for early development, clinical trials and manufactures. An effective CFR ensures that companies and organisations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and allows any handwritten signature to be replaced by an electronic one.

21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) guidelines on using electronic records and electronic signatures (ERES).

The scope of 21 CFR Part 11

includes operational areas of pharma, biotechnology or medical devices company

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such as: — manufacturing, maintenance and laboratory.

Leading pharma, drug discovery and development companies are aggressively investing in quality management systems through initiatives that assurance compliance with company and regulatory procedures and guidelines provide release and approval of all cGMP documentation, including Standard Operating Procedures (SOPs).

Labindia complies with CFR requirement in provision of 7’’ touch screen high resolution display with user interface and interactive software for ease of operation, LAN (Ethernet) connectivity facilitates data backup on network shared folder (optional), audit trail for all activities with search facility, report generation and printing, unlimited

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PHARMA ALLY / PACKAGING SPECIAL user IDâ&#x20AC;&#x2122;s with alphanumeric entries of user name, password and rolebased privileges selection.

Multi-level roles with password protection â&#x20AC;&#x201C; admin, manager, supervisor and user, user authentication is performed for each and every operation done by user, PDF report file, electronic instrument log book eliminates the paperbased equipment and facilitate logbook, USB printing eliminates the need of serial port to connect with instruments. The user can take printout on any local or network printer as well, electronic signature functionality, manual archive and restore facility and usb backup available.

21 CFR Part 11 states that records must be checked for accuracy dated and signed. These were seen as regulatory blocks on the pharma road to the digital world.

Moving to fully electronic data handling promised huge cost savings from improved efficiency and reduced physical handling and storage compared to traditional paper records, as well as increased security, traceability and transferability of data. It is not just in the manufacturing (GMP) area that electronic data handling offers noteworthy benefits. The amount of data generated in analytical laboratories operation under GLP is significant, and since this data requires review and approval signatures, 21 CFR Part 11 promises major improvements in workflows and data handling.

Contact details Labindia Analytical Instruments Head office: 201,Nand Chambers ,LBS Marg,Thane(w)-400 602 Tel: +91- 22- 2598 6000/ 2598 6110 E-mail: Sales.mfd@labindia.com Website: www.labindiaanalytical.com

48 EXPRESS PHARMA March 1-15, 2018

21 CFR Part 11 states that records must be checked for accuracy dated and signed.These were seen as regulatory blocks on the pharma road to the digital world. Moving to fully electronic data handling promised huge cost savings from improved efficiency and reduced physical handling and storage compared to traditional paper records, as well as increased security, traceability and transferability of data

Audit trail log

Option menu

PHARMA ALLY / PACKAGING SPECIAL VALUE ADD

Blister packaging goes EXPRESS with B&R technology Shyam Padwal, Branch Head - Mumbai, B&R Industrial Automation, talks about Express N, a newly designed blister packaging machine by IMA PG INDIAN pharmaceutical market is becoming more sophisticated and demanding. On one hand, adhering to regulations is mandatory and on the other hand, newer packaging designs are coming thick and fast amidst increasing pressure on manufacturers to reduce the cost of operations.

This trend is posing quite a big challenge to the machine builders, as they need to satisfy the varying needs in increasingly shorter time spans.

Conversely, this new development is seen as an opportunity at IMA-PG India, a Thane-based Indian subsidiary of IMA SpA, the global leader in packaging equipment.

“We at IMA PGrecognise that customer demands are a moving target. Demands keep changing and hence, so must our solutions. Our capability to deliver packaging solutions quickly for the complex requirements and at sensible prices, keep us ahead in the competition. Our association with B&R will continue to grow on the premise of achieving faster time to market and high quality automation systems,” says Prakash Pujare, Director – Design, IMA PG.

machine works on the shop floor and the way it interacts with the operator,” states Pujare.

Blister packaging in a nutshell

Shyam Padwal, Branch Head - Mumbai, B&R Industrial Automation

Machine in new packaging Express N, a newly designed blister packaging machine by IMA PG, accomplishes more than one objective. The new machine resulted into far quieter operations, flexibility through quick setup, inherent safety, intuitive operator interface and compliance with the FDA regulatory guidelines.

“B&R provided innovative as well as truly integrated automation technology. It played a crucial role in achieving tough targets. Multi-axis motion technology and intuitive visualisation transformed the way the

Blister packaging is a process, which packages products like tablets and capsules in a blister with cavities formed into a base film and then sealed using a thin lid foil. The choice of base film depends upon the degree of protection required by the product against ingress of moisture and exposure to light.

These cavities are formed using either thermoformable film or cold forming film.

Forming, sealing, feeding, pulling, cutting, non-fill and pinhole detection, and print mark controls are the major stations of this machine. Bottom foil passes through a forming station, which forms the cavity. A feeder unit places the tablets smoothly into the cavities. A sealing station seals lid foil and base film by heat and pressure.

A precise temperature control is essential for perfect sealing and ensuring the protection of the drug inside the packaging.

A print mark station, which consists of a sensor and an error detection mechanism, maintains accurate position of the pre-printed matter on the lid foil with respect to each blister. A cutting station at the end of the machine cuts the web into individual blisters. A transfer unit is typically added to place these blisters on a conveyor, which then leads to the next line machine i.e. a cartoner machine.

Evolution into mechatronic units Previous blister-packaging machines built by IMA PG had induction motor as the main prime mover. It also had two servo axis for web advance and feeder oscillation. However,

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analysis of the customer feedback as well as opinion of internal quality team led to the conclusion that the complex and lengthy mechanical transmission was a source of noise, backlash and imprecise relative shaft positions. Secondly, such a drive and transmission arrangement posed problems for changeover and increase in machine speed for higher productivity. The main motor was replaced by individual servo drives at each station. A shaft-less design allows machine operation to be more noise free, easy to setup a batch change, requires less

IMA PG team was pleased that B&R provides an open platform to integrate machine control, motion and vision system including pharma code and SAP code reader.

Automation PC is capable of running these tasks simultaneously

maintenance and offers greater flexibility in deciding start, stop sequence and positions.

Noise, no more Increase in the machine speed brings in its own challenges on the stability of the machine mechanics. Machine linkages become the source of vibrations and noise. Noise and vibration are not only irritants and harmful for the operator but can also potentially damage the product.

Product quality too can suffer due to adverse effects on sealing and printing, and consequent increase in rejections.

We at IMA PG recognise that customer demands are a moving target.

Our capability to deliver packaging solutions quickly for the complex requirements and at sensible pric es, keeps us ahead in the competition

Ashok Kumar Singh

Prakash Pujare

Manager Automation, IMA PG

Director – Design, IMA PG

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PHARMA ALLY / PACKAGING SPECIAL

Express N, a newly designed blister packaging machine by IMA PG, accomplished far quieter operations, flexibility for the quick setup, inherent safety, intuitive operator interface and compliance with the FDA regulatory guidelines

Highly intuitive visualisation based on B&R’s touch panel is a result of seamless integration of machine operation, vision system and audit trails in compliance with 21 CFR Part 11

Compact yet powerful Automation PC integrates motion,controls, visualisation and vision system Prakash Pujare with his team

Improving productivity through machine GUI Automation allows the machine builder to hide the complexities from the operator.

One of the key goals at IMA PG for this project was that increased machine performance, easy setting up, and better diagnostics were needed without increasing the operator’s interface burden. “IMA PG team was pleased that B&R provides an open platform to integrate machine control, motion and vision system including pharma code and SAP code reader. Automation PC is capable of running these tasks simultaneously. A single user interface was then sufficient for the whole ma-

50 EXPRESS PHARMA March 1-15, 2018

chine operation. This solved more than one problem for us,” stated Ashokkumar Singh, Manager Automation, IMA PG.

Complete redesign with B&R “Introducing individual drives and having an integrated HMI for machine operation was necessary to achieve our targets. This required a complete redesign of the machine and we went back to the drawing board for extensive changes to the existing concepts of driving station and controlling of various machine parameters.

We evaluated automation solution from B&R in all the categories – controls, HMI, PC and

motion technology. We realised that integrated automation concept will be at the core of the solution,” says Pujare. IMA PG zeroed in on Automation PC to implement and integrate machine visualisation and vision system interface. Individual servo axis were selected for all the main stations i.e. forming, sealing, feeding, web indexing and cutting.

More machine intelligence through software With the regulatory compliance playing a major role, users expect that the machine itself should generate production reports and IT department should handle the user management over factory

LAN. Audit trail and data handling were easily achieved with the help of modular application development solution i.e. mapp Technology. With mapp, B&R has brought a revolutionary software concept in the market. The programmer is relieved from routine code development and achieves far better software quality and faster project development owing to the need of just configuring the mapp components. Even for the multi-axis motion control, mapp Technology drastically reduces the complexity of the programme.

PackML ready OMAC PackML too has been implemented and provided as

an optional feature for the customer. With the implementation of PackML, machine states are clearly defined and the user gets a standard interface to connect other line machines.

This will be of help to IMA PG for their turnkey solutions of complete production lines including several upstream and downstream machines.

“Our new Express N machine sets the bar very high with respect to the integration of motion, controls, visualisation and vision systems.

Machine monitoring, reporting as well as the implementation of PackML makes it a complete state-of-the-art blister packaging machine,” concludes Pujare.

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S. P. PRODUCTS

TM

PHARMA EQUIPMENTS AT IT'S BEST

S.S. MULTIPURPOSE TROLLEY

S.S. VIAL / AMPOULE BOX

S.S. CAGE TROLLEY

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S.S. CONTAINER (5LTR - 500LTR)

S.S. STEP OVER BENCH WITH SHOE RACK

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S.S. CABINET FOR BLISTER S.S. LOCKER S.S. VISITOR CHANGE PART / STRIP CH PART / FOR KEEPING APPRON CABINET POLYBAG STREET GARMENT

• All products are custom made & available in 304, 316 & 316L Quality with optional Matt & Mirror finish.

• We undertake the side work of Cladding of Machinery & others.

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S.S. CABINET FOR MULTIMILL SIEVES

S.S. WRITING DESK WITH DRAWERS

S.S. II CHANGE CROSS OVER BENCH

Contact: Mr. Kiran Shah / Mr. Chirag Shah

S.S. DIES & PUNCHES CABINET

OFFICE: F-823, VEENA SANTOOR BLDG., NEAR PAWANDHAM, BEHIND 'D' MART, MAHAVIR NAGAR EXTN. ROAD, BORIVALI (W), MUMBAI-400092. TELEFAX: 28197068 / 3082 MOBILE: 98200 54453. Email: info@pharmaequipments.com URL: www.pharmaequipments.com WORKS: W6, OM SAI COMMERCIAL COMPLEX, GODDEO ROAD, NEAR EKVIRA GAS GODOWN, BHAYENDER (EAST), THANE - 401 105 TEL: 2819 3082

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

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EMERGING AS THE MOST PREFERRED PRIMARY PACKAGING SOLUTIONS PROVIDER FOR THE PHARMA INDUSTRY. CALENDER

Uniworth Enterprises LLP with it's location at Ahmedabad, INDIA, is ideally suited to cater efficiently to the Indian market and with ICD facility and excellent connectivity by road to Nhava Sheva port, Mumbai, can also service the export market with minimum time lag between production and export.

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ANTI-INFLAMMATORY ENZYMES ü Serratiopeptidase ü Peptizyme (enteric coated serratiopeptidase granules) ü Trypsin Chymotrypsin mix (6:1)

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ADVANCED ENZYME TECHNOLOGIES LTD. Sun-Magnetica, ‘A’ Wing, 5th Floor, LIC Service Road, Louiswadi, Thane (W) 400 604 Tel: +91-22-4170 3200 | Fax: +91-22-2583 5159 Email: info@advancedenzymes.com | www.advancedenzymes.com

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Clear view Autoclavable Panoramic Thermoplastic rubber Body Goggles With 40 Autoclave Cycles, Can Be Worn Over Eyeglass With Grid For Marking Autoclaving Goggles

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Cleaning Products For Cleanroom For ISO 5 To ISO 8 Facility 11X14EPAd02

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Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Kailash Purohit +91 9552537922 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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LABORATORY EQUIPMENTS

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PHARMA LIFE AWARD

Sun Pharma Science Foundation recognises Indian scientists Scientists were presented the awards for exemplary contribution in pharma and medical science

S

un Pharma Science Foundation, a non-profit organisation, announced the Sun Pharma Science Awards to Indian scientists for their outstanding work and exemplary contribution to medical research.

These awards were presented in two categories – The Sun Pharma Research Awards for outstanding scientists and Sun Pharma Science Scholar Awards for young researchers.

The winners for both these awards were identified in two sub-categories – Medical Sci-

ences and Pharmaceutical Sciences. A jury panel comprising

well-known scientists from India selected the final winners.

STATEMENT ABOUT OWNERSHIP AND OTHER PARTICULARS OF EXPRESS PHARMA, MUMBAI, AS REQUIRED UNDER RULE 8 OF THE REGISTRATION OF NEWSPAPERS (CENTRAL) RULES, 1956 FORM - IV (SEE RULE 8) 1. Place of Publication 2. Periodicity of its publication 3. Printer's Name Whether citizen of India Address 4. Publisher's Name Whether citizen of India Address 5. Editor's name Whether citizen of India Address 6. Name and address of individuals who own the newspaper AND Shareholders holding more than One per cent of the total capital

: Express Towers, 1st Floor Nariman Point, Mumbai-400 021 : MONTHLY : Ms. Vaidehi Thakar : Yes : Express Towers, Nariman Point, Mumbai-400 021 : Ms. Vaidehi Thakar : Yes : Express Towers, Nariman Point, Mumbai-400 021 : Ms.Viveka Roychowdhury : Yes : Express Towers, 1st Floor Nariman Point, Mumbai-400 021 : The Indian Express (P) Ltd Express Towers, Nariman Point, Mumbai 400021 : Indian Express Holdings & Entp Private Limited Express Towers,Nariman Point, Mumbai 400021 : Mr. Viveck Goenka & Mr. Anant Goenka Express Towers, Nariman Point Mumbai 400021 : Mr. Shekhar Gupta & Mrs. Neelam Jolly C-6/53, Safdarjung Development Area New Delhi 110 016

I, VAIDEHI THAKAR., hereby declare that the particulars given above are true and to the best of my knowledge and belief.

Date : 1/3/2018

70

EXPRESS PHARMA

March 1-15, 2018

sd/VAIDEHI THAKAR Publisher

These awards were presented annually to Indian scientists and young researchers working in India and abroad.

The awards were presented

by Prof Vishwajit Nimgaonkar, Professor of Psychiatry and Human Genetics at the University of Pittsburgh, USA and Dilip Shanghvi, MD, Sun Pharma.

The winners were: Dr Rajan Sankaranarayanan, Chief Scientist, CSIR-Centre for Cellular and Molecular Biology, for his outstanding contributions in the area of protein biosynthesis, by studying proofreading mechanisms using structural biology approaches; Dr Vikram Mathews, Associate Director, Professor and Head, Department of Clinical Haematology, Christian Medical College, for his outstanding work in Acute Promyelocytic Leukemia (APL) and the use of arsenic trioxide (ATO) in the treatment of this condition; Prof Ashish Suri, Professor of Neurosurgery, Neurosciences Center, All India Institute of Medical Sciences, for his pioneering research in developing innovative techniques and treatment protocols for complex skull-base and brain tumour surgery; Dr D Srinivasa Reddy, Senior Scientist, Division of Organic Chemistry, CSIR-National Chemical Laboratory, for his work in the

area of total synthesis of biologically active natural products and medicinal chemistry using ‘silicon incorporation approach’ towards identification of lead molecules of therapeutic potential; Punita Kumari, Biological Sciences & Bioengineering department, Indian Institute of Technology, for developing a better understanding of the signalling and regulation of G protein-coupled receptors (GPCRs); Aditi Jain, Senior Research Fellow, Centre for BioSystems Science and Engineering, Indian Institute of Science, for her research work on ‘Understanding cardiac failure using engineered materials’; Gaurav Joshi, Junior Research Fellow, Laboratory for Drug Design and Synthesis, Department of Pharmaceutical Sciences and Natural Products, Central University of Punjab for his research work entitled ‘Targeting chromatin coupled enzymes by small molecules in cancer cells’; Shasank Sekhar Swain, Central Research Laboratory, Institute of Medical Sciences & SUM Hospital, Siksha ‘O’ Anusandhan (Deemed to be University), for his innovative research work, ‘Conjugation of a phytochemical with an obsolete drug as a novel strategy towards antimicrobial drug discovery: a case study with sulfonamide-monoterpene phenols against MRSA.’ Sun Pharma Science Foundation also conducted its annual conference on the subject, ‘Training Pathways for Physician Scientists’ in association with Translational Health Science & Technology Institute, Faridabad. Prof K VijayRaghavan, Former Secretary DBT, Government of India, delivered the inaugural address. Eminent scientists from India and abroad participated in the conference.

EP News Bureau

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