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PHARMA PACKAGING AND LABELLING CONCLAVE Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble 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

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FOREWORD PACKAGING MATTERS

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n an age of information overload, where our senses are bombarded by visual, audio and all manner of stimuli, how can a product stand out? Quite simply, the answer is packaging. Because better packaging can go a long way to “sell” the product. It is packaging that creates a personality for a brand, a promise that the user can touch and feel even before she uses the product within. With medicines, this bond of trust needs to be even stronger than other purchases. So, who are the architects of this all important component of a product, the packaging? For medicines, the packaging design ideally starts at the R&D stage, evolving as the product moves through formulation R&D to finally commercial production. Along the way, supply chain experts pitch in with their expertise while finance steps in to keep an eagle eye on the costs. Regulations across geographies impact packaging design as do global initiatives to use less packaging material. And patient-centric packaging demands that we look for the best design for different demographic segments: senior citizens, children. Can we increase compliance through innovative delivery devices using packaging as the pivot? Can the packaging double up as a shield against counterfeiters, allowing governments and corporates alike to track and trace medicines across borders? Packaging in the pharma industry is already doing all this and more, thanks to the drive and determination of an elite cadre of professionals, who chose to specialise in pharma packaging. Patients, both in India and across the world, are touched by the efforts of these individuals, yet they remain faceless to most of the world. But not anymore. Express Pharma presents the first edition of the Pharma Packaging and Labelling Leadership Handbook, comprising 40+ profiles of these leading lights. We look forward to discovering many more professionals and featuring them in the second edition. We preface this book with inspirational messages from our Advisory Board, Mr AVPS Chakravarthi, Mr Gautama Buddha, Mr SM Mudda and Dr Praful Naik, who helped us conceptualise the Handbook, the agenda of the PPL Conclave where this Handbook will be launched as well as choose the winners of the PPL Leadership Awards. The Handbook also pays tribute to the pioneering role of stalwarts of the industry, Mr Ajit Singh, Chairman, and Mr Jasjit Singh, ACG Worldwide and Kairus Dadachanji, Managing Director of Schott Kaisha, who brought world class pharma packaging technologies to India and in turn, pivoted India to a global leadership position. We salute their chutzpah and know that they are an inspiration to future entrepreneurs in this arena.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com PHARMA PACKAGING AND LABELLING CONCLAVE | 3


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CONTENT 08

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GAUTAMA BUDDHA TSR CONSULTANT

KAIRUS DADACHANJI SCHOTT KAISHA

BARUN DEY DR REDDY’S LABORATORIES

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CHAKRAVARTHI AVPS GLOBAL AMBASSADOR, WORLD PACKAGING ORGANISATION

AJAY BAPAT EMCURE PHARMACEUTICALS

DR SRINIVAS ARUTLA APOTEX RESEARCH

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PRAFUL R NAIK PRASHAK TECHNO ENTERPRISES

ANAHITA KARANDE ALEMBIC PHARMACEUTICALS

GANESH KUMAR VALLURI HOSPIRA HEALTHCARE INDIA

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SM MUDDA MICRO LABS

AVINASH KUMAR TALWAR DR REDDY’S LABORATORIES

HARPAL SINGH GLENMARK PHARMACEUTICALS

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26

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AJIT SINGH ACG

AVINASH ARVIND BALLAL SERUM INSTITUTE OF INDIA

JAYANTI SAWANT CONSULTANT

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JITENDRA JAYWANT JADHAV WOCKHARDT

P SRINIVAS NAIDU SUN PHARMA

PRAFULL V. DESHPANDE LUPIN

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KIRANKUMAR LADEWAR BIOLOGICAL E

PARAS JAIN PIRAMAL ENTERPRISES

PRASAD GHANSHYAM SATAM AUROBINDO PHARMA

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MANJUNATH NADELLA MSN LABORATORIES

PAVANKUMAR S PATIL SRI KRISHNA PHARAMACEUTICALS

NARLANKA PRAVEEN KUMAR AUROBINDO PHARMA

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MANOJ KUMAR TELUGUNTLA CADILA HEALTHCARE (ZYDUS GROUP)

PRABIR KUMAR DAS MYLAN LABORATORIES

R CHANDI PRASAD AUROBINDO PHARMA

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MUNINDRA ROY GLAND PHARMA

PRADEEP A DHARGALKAR UNICHEM LABORATORIES

RAHUL BHARGAVA SUN PHARMA

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RAJENDRAKUMAR N SUTHAR SERUM INSTITUTE OF INDIA

SHANTANU SHOME HOSPIRA HEALTHCARE INDIA

SRIMAN BANERJEE GLAXOSMITHKLINE CONSUMER HEALTHCARE

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RAJESH KUMAR MISHRA ABBOTT HEALTHCARE

TJ SARAVANAN BIOCON

SURESH GANAPURAM INTAS PHARMACEUTICALS

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RAJSHRI CHETAN PARDESHI UNOSOURCE PHARMA

SHIVAJI CHAKRABORTY FRESENIUS KABI ONCOLOGY

TRIPTI NAKHARE FDC

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REETIKA PRASHAR MERCK

SOUMYANATH MISHRA MANKIND RESEARCH CENTRE

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SANTANU CHOWDHURY SUN PHARMA

SOURAV MITRA MYLAN LABORATORIES

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GAUTAMA BUDDHA TSR PACKAGING CONSULTANT & GUEST FACULTY, IIP

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autama Buddha is a post-graduate in Chemistry from Andhra University and also did his Post graduate diploma in Materials management from Bharatiya Vidyapeeth. He started his career as a Junior Research fellow at CFTRI Mysore, subsequently served many Pharmaceutical organizations such as Ranbaxy Laboratories, Parke-Davis India, Dabur Research Foundation, Pharmax Corporation and Dr Reddy’s Laboratories in packaging development in various capacities for 33 years. Superannuated from Dr Reddy’s Laboratories in 2013, after 13 years of rich experience as Senior Director - Packaging development. Under his leadership the team at Dr Reddy’s, received many awards such as Indiastar, Asia star, World star and Ameristar for pack excellence. Filed three patents on innovative packaging towards customer convenience and customer safety. Recognised as ‘Packaging professional of the year’ at World Brand congress held at Mumbai in 2012 Currently working as a Packaging consultant and also a guest faculty at Indian Institute of packaging. He has participated in national and international seminars as a speaker.

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OVERALL,THERE IS BOUND TO BE SIGNIFICANT DEMAND FOR PHARMA PACKAGING IN BOTH DEVELOPED AND DEVELOPING MARKETS. INNOVATIVE PACKAGING FOR COMPLIANCE AND CUSTOMER FRIENDLY DESIGNS WILL GAIN FOCUS

OUTLOOK ON PHARMA PACKAGING INDUSTRY lobal pharma packaging market was sized at$ 77 billion in 2016 and is expected towitness substantial growth owing to the raising demand from emerging markets. Packaging is gaining lot of importance since the past few years as it is assuming critical role in dosage compliance, accurate dose delivery, patient safety and communication. Shift from hospital administration to self administration for chronic diseases in developed markets is gaining importance. Strong growth in the healthcare sector around the world and increasing functional requirements for healthcare packaging products are some of the key growth factors in the global market. A global ageing population, changing lifestyles and the increasing prevalence of chronic diseases will strengthen the demand for healthcare products and services and thus stimulate growth. Also raise in out sourcing of pharma manufacturing to emerging economies is expected to open new growth avenues in the

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market. Retail pharmacy is expected to experience decrease in demand owing to number of e-commerce portals selling medicines. Change in government policies towards health insurance in developing countries will impact in affordability and inturn increase the demand further. Overall there is bound to be significant demand for pharma packaging in both developed and developing markets. Innovative packaging for compliance and customer friendly designs will gain the focus. CHALLENGES IN PHARMA PACKAGING In the healthcare business we are facing many challenges such as ever increasing regulatory requirements of individual countries. Complex molecules/formulation requirements need high barrier materials. Intellectual property barriers, safety regulations and increasing threat from counterfeiters needs special insights into packaging . In addition global competition and tender markets are demanding for optimising packaging costs. Apart from the above, logistics for cold chain

products to reach end of the chain, customer convenience and compliance requirements, child safety requirements and user friendly features also pose greater challenges. MESSAGE TO THE INDUSTRY We need to take every challenge as an opportunity to develop innovative packing to overcome the barriers. Innovation shall become a continuous process addressing current and future challenges. Innovation shall lead to increased sale and health of organisation which in turn leads to more investments on innovative developments. Hence innovation shall become a culture in every development. Keeping abreast with latest developments is important for smooth sailing in the current scenario . Build worst case studies in anticipation during development and plan for risk assessment and risk mitigation. Differentiation in the final pack will give you better identity and better mileage for the product. PPL conclave is an excellent platform for packaging innovations andto understand the global trends in the healthcare industry.

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CHAKRAVARTHI AVPS GLOBAL AMBASSADOR, WORLD PACKAGING ORGANISATION

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hakravarthi AVPS, the CEO and MD of Ecobliss India (a joint venture with Netherlands-based MNC), is a global leader in innovative blister packaging solutions. He was recently appointed as ‘Global Ambassador of World Packaging Organisation’, the first ASIAN to get this coveted international position. He was the winner of Worldstar Awards (the highest in packaging excellence) for five years in a row with 100 per cent success, a world record! He also holds the credit of being the lone winner of an AmeriStar in pharma packaging from India. He has more than three decades of experience in paper, printing and packaging fields and has been instrumental in developing various pharma compliance packs for the US and other regulated markets. Chakravarthi has published articles in various magazines and participated in live TV programmes of public interest. He has also toured extensively worldwide, during the past two and half decades! He has been a speaker on various international platforms in more than fifteen countries and has been the jury for different award competitions, worldwide. Delivered lectures and chaired various sessions on different topics in FICCI,CII, IIP, CPHI, APF, WPO, Iphex, FAPPCCI, WPC and so many other platforms. He was honoured with a special recognition award at India Pharma Awards by UBM for his contribution to the pharma packaging industry during CPHI India in 2017.

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THE FIELD OF PACKAGING OF DRUGS AND PHARMA PRODUCTS HAS WITNESSED A REVOLUTION IN THE RECENTYEARS.THE TREND HAS ALSO BEEN ACCELERATED BY ECONOMIC LIBERALISATION

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harma packaging in India too has evolved over the last three decades to meet the challenges in the upkeep of drug efficacy and at the same time ensure regulatory compliance in different parts of the world. The field of packaging of drugs and pharma products has witnessed a revolution in the recent years. The trend has also been accelerated by economic liberalisation. The designing of packaging and its labelling is being decided right at the product development stage, keeping factors such as convenience, safety, patient adherence etc. Patients’ demand for safer, easier to use, administration technologies, coupled with the drug industry’s desire to reduce costs and increase efficiency, are key drivers in the evolution of innovative technologies in pharma packaging. Packaging can actually play a key role in protecting the pharma supply chain. Swift and effective communication among all the stake holders viz., industry, users, and regulatory/controlling/clearing authorities

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is possible by adopting best packaging practices. However, translating a userfriendly design into adhering all technical specifications and addressing multiple user groups in the broadest sense, is always a challenge. Especially, when you need to consider people of different culture, habits, age, language their ability so on. Hence, clear dosing instructions, package design and colour coding have now become basic requirements of any pharma packaging. Serialisation and track and trace technology is also big part of the pharma industry in India. With mega trends like big data, cloud and the Internet of Things, we anticipate that adoption will continue as the Indian pharma industry matures and as machine data generated reaches a tipping point that accelerates mass adoption. In other words, the subject of packaging has become very important for marketing of any product. Besides, packaging of drugs also needs to satisfy consumer expectations. Actually packaging adds value, ensures drug quality and freshness, provides tamper

identification, arrests spurious drugs entry, keeps check on adulteration, vehicle for product story, helps meet statutory regulations, source for brand and co identify, offers traceability, aid for storage/ productivity/distribution, silent sales resource and aids market promotion. It is heartening to note that Express Pharma has initiated the Pharma Packaging & Labelling Conclave to set up a platform for packaging leaders and experts to come together to discuss, debate and deliberate current and future trends in the industry. This is a big opportunity for all the stakeholders to gain direct insights from industry leaders and get updated on the latest developments in Indian packaging industry. I am also very glad about the initiative of recognising the pharma packaging contributors from the industry and felicitating them on this occasion. I feel happy to be a part of this big initiative and wish this maiden venture from Express Pharma a grand success.

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PRAFUL R NAIK PARTNER & CEO OF PRASHAK TECHNO ENTERPRISES

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raful Naik is the Partner, Founder Director & CEO of Prashak Techno Enterprises. Naik has diverse, multifaceted experience encompassing R&D, technical services, regulatory, quality systems, contract manufacturing and intellectual property management in the pharma sector with companies such as Bilcare, Johnson & Johnson; Smith Kline Beecham Pharmaceuticals and Cadila Pharmaceuticals. Naik has been a member of the Sectoral Innovation Council on Intellectual Property Rights and National IPR policy constituted by the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India; Member, Expert Committee of Indian Pharmacopoeia Commission; Member, National Working Group on Scientific & Technological Measures to counter spurious and sub-standard drugs constituted by the Principal Scientific Adviser to Government of India; and is the Member of the CII’s National Committee of IP Owners as well as Member, National Technical Committee of ‘Habitat for Humanity’, India. In 2015, Naik was nominated to the Technical Committee & Working group of the Center of Excellence formed jointly by The Patient Safety & Access Initiative of India Foundation and Indian Institute of Technology, Banaras Hindu University for enabling initiatives leading to safe medicines and access to Quality healthcare by patients. Naik has received several awards and accolades such as the Certificate of Innovation for the nonClonable security technology at ‘Innovations 2010’, ‘Outstanding Performance Award’ by Institute of Pharmaceutical Education & Research, and ‘Distinguished Service to Profession’ by Association of Pharmaceutical Teachers of India. Naik, a doctorate in Pharmaceutics from IIT, BHU has over 40 granted patents with over 140 patent applications globally. He has authored 10 research-papers and has lectured at several national & international forums including being invited speaker at Science and Technology Forum 2010 at Kyoto, Japan to speak on ‘Security in Age of ICT’.

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PHARMA SCIENTISTS ARE ACKNOWLEDGING PACKAGING AS THE CORE ENABLER FOR THEIR PRODUCTS TO REACH SAFELYWITH THE DESIRED WORTH FROM THE POINT OF SOURCE TO THE POINT OF USE,TILLTHE TIME IT GETS CONSUMED BYA PATIENT

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ackaging plays the pivotal role in enabling and ensuring not only the quality, safety and efficacy of a pharma product but also that the right and authentic product gets consumed by the patient. It therefore essentially becomes an integral part of a pharma dosage form and opine that it can be uniquely categorised as "non-edible pharma substance". Very few people know that India was the first country in Asia to commence Clinical Trial material (CTM) manufacturing and

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packaging and a non-pharma company Bilcare was assigned this crucial task on the basis of its core strength and expertise in packaging science for pharma products. It is heartening to see packaging taking new dimensions and leaps in the global pharma sector with the pharma scientists acknowledging packaging as the core enabler for their products to reach safely with the desired worth from the point of source to the point of use, till the time it gets consumed by a patient.

"Innovation" is a novel unifying element without competence boundaries which has the power to instigate "Ideas to IP" using a core from one field and transforming into an immensely valuable application in an entirely unrelated sector. Innovations in pharma packaging is the need of the day to propel the mind set shift from "Product Centric to Patient Centric" approach. The Pharma Packaging Conclave is a path-breaking and constructive initiative towards accomplishing this vital objective.

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SM MUDDA DIRECTOR – GLOBAL STRATEGY (TECHNICAL), MICRO LABS

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M Mudda has more than 40 years of wide experience in the pharma industry covering operations, technical, quality, regulatory and management aspects of pharma manufacturing for domestic and international markets. He is currently serving as Director – Global Strategy (Technical) at Micro Labs, Bangalore and is responsible for all technical strategic decisions of the company. He has significantly contributed to the company’s growth by introduction of several new products in all dosage forms using modern technologies and by transformation of manufacturing operations from domestic standards to current global standards. He has designed and introduced Corporate Quality Management System for uniform implementation of GMPs across all functions and plants. These plants have gone through several regulatory inspections and have been approved by the global regulatory agencies. He is also actively involved in promoting ongoing education activities at the industry level and also engaged with regulatory authorities in the process of review and amendment to the regulations applicable to the pharma industry. He is amember of pretigious organisations including member of Scientific Body of Indian Pharmacopoeia Commission, nominated by Ministry of Health, Government of India, IDMA, Mumbai, Pharmexcil etc. As Chairman of Regulatory Committee, IDMA, Mudda has been actively involved in the review of various draft regulations and in representing the interest of the industry. Some of these include, Regulations related to , DGFT Bar Coding, Spurious and Adulterated Drugs, FDCs, NLEM and DPCO 2013, CDA Bill 2013, Drugs & Cosmetics (Amendment) Bill 2015 etc. He is the Program Director of a successful, ‘Advanced Program in Pharmaceutical Quality Management launched in 2017 in collaboration by IDMA and NSF, UK. He is also the co-author of a book ‘Label Design and Labelling of Drugs’ along with RS Iyer (a renowned quality guru).

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THE PHARMA PACKAGING INDUSTRY CAN PLAYAVITAL ROLE IN DEVELOPING THE BEST-IN-CLASS TECHNOLOGYTO PREVENTTHE DRUG COUNTERFEITING WHICH IS ONE OFTHE SERIOUS GLOBAL CONCERNS

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ndian pharma packaging industry is evolving and emerging as a significant industry among other frontline sectors in the country. The importance of the packaging in ensuring quality, safety and integrity of the product through the supply chain has been recognised by the industry. Several innovative packaging solutions have been provided by the industry in collaboration with R&D scientists of the pharma industry. As a member of jury panel of UBM India Pharma Awards, I have witnessed several such examples that is heartening to see. The global regulatory agencies have started emphasising on the quality and functionality of packaging components and it is expected that in addition to the normal product quality attributes , additional attributes related to primary/secondary packaging components based on patient - failure mode are identified and provided for in the design of the product to ensure integrity, safety and convenience of use by the patients.

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Counterfeit prevention: The pharma packaging industry can play a vital role in developing the best-in-class technology to prevent the drug counterfeiting which is one of the serious global concerns. The industry has come up with an array of security techniques to combat this issue, with varying success and will play a significant role in controlling the counterfeit trade. Improving the health of the people by providing quality medicines is the principle responsibility of all stakeholders of the healthcare, pharma and allied industries. Providing innovative, cost-effective, patientfocused solutions will provide our industry a competitive advantage. We should therefore be committed to develop innovative medicines, adoption of modern technology , migrating to electronic platform for operations, process control and data management. Ultimate objective should be to achieve excellence by distinguishing ourselves from our global competitors in innovation, quality, cost, delivery and customer delight.

With this focus, we will be rightfully regarded as the ‘Pharmacy of the World’. Major learnings 14 principles of Quality Management and the 94/6 Rule- 94 per cent of the problems in the business are systemdriven and six per cent are people driven are guiding principles that I have adopted in management of quality. In fact, I consider adoption of quality systems approach for consistent implementation of good manufacturing practices (GMP) as the philosophy behind the practice. ● Development of systems and leadership for management of quality is possible only if we stop incentivising the outcomes rather than the means adopted to achieve it. Shifting focus from KPIs to key behavioral indices (KBIs) is the prerequisite for leadership development. ● High level of discipline in our working and focus on improving quality of work will ultimately determine the quality of our products. ● Deming's

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✪ EDUCATION: CAMBRIDGE UNIVERSITYAND HARVARD BUSINESS SCHOOL ✪ CURRENT ORGANISATION: ACG ✪ DESIGNATION: CHAIRMAN ✪ AWARDS & RECOGNITIONS ● MEMBER OF PRESTIGIOUS ORGANISATIONS,ASSOCIATIONS AND INSTITUTIONS SUCH AS IITs, GOVERNMENT OF INDIA’S 5-YEAR SIXTH PLANNING COMMITTEE PANEL, LEADING PHARMAASSOCIATIONS,AAPS TASK FORCE, PHARMEXCIL, CONTROLLED RELEASE SOCIETY ETC RECEIVED VARIOUS PRESTIGIOUS AWARDS SUCH AS: ● DIWAAWARD – 2002 AND A DOYEN OFTHE PHARMACY PROFESSION”BY THE DRUGS INSPECTORS ASSOCIATION (DIA) MAHARASHTRA STATE, MUMBAI ● DISTINGUISHED SERVICES AWARD FROM INDIAN PHARMACEUTICAL ASSOCIATION (IPA) ● BESTVENDOR AWARD FROM THE ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA (OPPI)

AJIT SINGH

16 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING Ajit Singh's journey, alongwith partner and brother Jasjit Singh, nephew Karan Singh, and their senior associates have been one of continuous innovation. With a focus on indigenised technology, they have built manufacturing quality capsules, advanced pharma machinery and sophisticated pharma packaging films, with over 20 factories, offices and warehouses in various countries. With over 40 patents, ACG is one of the world’s largest integrated pharma consumables and machinery supplier in solid dosage forms which is the leading pharma formulations segment. The benefit to pharma companies, including the public sector, is that they are provided with world-class products at affordable prices.

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WE SHOULD PREVAIL UPON THE GOVERNMENTTO HELP US BRING PHARMA PACKAGING TO WORLD STANDARDS AND ALSO CONVINCE PHARMA INDUSTRYTO ADOPTTHESE STANDARDS

EVOLUTION OF PHARMA INDUSTRY In the initial years, of the 1960s, 70s, and 80s, when more modern pharma packaging made its appearance, the packaging industry had inadequate experience, and little access to technology. It was difficult to import the right type of equipment and raw materials for better quality of packaging due to foreign exchange control by the government. At a later stage, with the development of pharma industry, the demand for good quality packaging exceeded supply. Therefore, except for a few far-sighted suppliers no real efforts were made by the packaging industry to improve their quality to near world standards. Over the last few years, however, tremendous progress has been made in the industry. Packing materials and machinery are now even being exported. The main issue today is the government’s reluctance to provide higher drug prices to cover the costs of the required superior packaging, equivalent to that used in most other countries.

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LEADERSHIP IN PHARMA PACKAGING Leadership in pharma packaging is more or less the same as leadership in any other sphere of activity. A leader should constantly be concerned about the sustainability of the organisation. In my opinion, anticipation of problems and excellence in all areas is, in my opinion, is a leadership task even if this is at the cost of some growth. He/she constantly keeps the patient’s safety and convenience foremost. He/she should be an integrator but also something of an activist. And, for a little excitement, a contrarian and a disruptor. In the top position, he/she can afford to be. GEARING FOR THE FUTURE We should gear ourselves up to prevail upon the government to help us bring pharma packaging to world standards and also convince pharma industry to adopt these standards. Fake drugs in the market are an area of concern. It is said that the profits made by

falsified medicine manufacturers are so high that they use much better quality packaging. Therefore, if the pack of fake and genuine drugs are held side by side, often the fake looks more genuine. Interestingly, one also observes that for several decades, the packaging of another drug, namely nicotine in cigarettes, has always been superior and better looking than the packing of medicines. The menace of fake drugs can be handled with use of newer technology, fortunately now available. The supply chain can be greatly strengthened by the introduction of track & trace systems. The capsule dosage forms cannot be substituted with fake drugs by using printing in three to four colours with complex designs. This protection is now available at a very nominal cost. MESSAGE FOR THE INDUSTRY Even though the quality of packaging has improved greatly in the last few years, there is still much to be done.

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✪ EDUCATION: BACHELOR OF COMMERCE ✪ CURRENT ORGANISATION: SCHOTT KAISHA ✪ DESIGNATION: MANAGING DIRECTOR ✪ EXPERIENCE IN PHARMA INDUSTRY: 26 YEARS ✪ AWARDS & RECOGNITIONS : TWICE WINNER OFTHE OPPI BESTVENDOR AWARD IN PRIMARY PACKAGING CATEGORY MERCK BESTVENDOR AWARD IN PRIMARY PACKAGING.ACTUALIDAD AWARD. LEADER IN PRESTIGE & QUALITY, EUROPE 2006

KAIRUS DADACHANJI

18 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Introduced color break and OPC (one point cut opening method for ampoules in India) ● Introduced camera inspection systems for ampoules/vials in India ● Introduced anti-counterfeiting ampoules in India with nanotechnology ● Introduced blow back vials in India for lyophilised containers ● Introduced siliconised vials in India ● Introduced ammonium sulphate treated vials in India ● Introduced closed ampoules in India ● First to launch pre-crimped sterile nested cartridges in India. ● First to introduce sterile vials and cartridges in India both in tray and nested format ● First to introduce sterile prefillable syringes in India at international standards

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PHARMA COMPANIES NOWWORK WITH SUPPLIERS AS PARTNERS AND NOTJUST VENDORS ANY MORE. CO DEVELOPMENT BETWEEN PACKAGING INDUSTRYAND PHARMA COMPANIES IS GAINING GROUND

DEMANDING ASPECTS OF PHARMA PACKAGING ● Quality ● On time delivery ● Ability to deliver huge volumes at short notices.

conscious of the risk they face, fda is tightening the gaps and pushing pharma to improve. Pharma companies now work with suppliers as partners and not just vendors any more. Codevelopment between packaging industry and pharma companies is gaining ground.

EVOLUTION OF THE PHARMA PACKAGING SECTOR More than in the last few decades, we can say that, in the last decade there has been an immense change. The quality requirement is going higher and higher, people are getting more

LEADERSHIP IN PHARMA PACKAGING It includes several aspects such as: One’s ability to stay ahead of the competition is very important. To be able to foresee what's coming and what's going to be expected, and proactively preparing for the

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same is what defines ones leadership position. The ability to provide millions and millions of pieces, month on month, and year on year with the same consistency of quality is clearly the winner. MESSAGE TO THE INDUSTRY My message is to try to understand the needs of pharma customers and provide them with solutions for their needs rather than what one is manufacturing. In simple words, don't find customers for your products, find products for your customers.

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✪ EDUCATION: POST GRADUATE IN BIO-CHEMISTRY ✪ CURRENT ORGANISATION: EMCURE PHARMACEUTICALS, PUNE ✪ DESIGNATION: HEAD, PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: TOTAL OF 31 PLUS YEARS IN PHARMA PACKAGING INDUSTRY (WORKED WITH LUPIN, SOL PHARMA,WOCKHARDTAND EMCURE PHARMACEUTICALS)

AJAY BAPAT

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CONTRIBUTION TO INNOVATION IN PACKAGING Without innovation you cannot sustain in business. If you need to be successful, keep on thinking up new ideas. It is not necessary that you have to always think big to be innovative. Whichever idea helps internal or external customers is innovation. In my opinion, it is not necessary to have a new pack design to show innovation, but even a small change, which can increase productivity or give ease in operation to the machine operator, can be considered innovation. As mentioned above, there are lot many direct or indirect benefits to the organisation. With minor suggestions and adopting small changes, have helped the organisation in a big way. It has become a habit and a practice to continuously evaluate and look for customer benefits.

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WITH OPTIMUM DESIGN OF PACKAGING,WE ALSO TRYTO HELP THE ENVIRONMENTAND REDUCE THE WASTAGES

TRENDS IN PHARMA PACKAGING Customer convenience is considered in a big way as we normally take continuous feedback on any new design or packs from market through our marketing division. With optimum design of packaging, we also try to help the environment and reduce the wastages. CHALLENGES IN PHARMA PACKAGING There are lot many challenges as the industry is on continuous growth curve .

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GROWTH DRIVERS In my opinion the most important aspect for any pharma packaging professional is to keep oneself updated with latest trends and developments happening around the world. Only if you know, you can think of change. ● Continuous evaluation of marketed packs and feedback from market. ● Customer- centric approach rather than just pack it and forget it approach. ●

MESSAGE FOR THE INDUSTRY Packaging is an integral part of the pharma industry and one of the most important aspects of growth for the pharma industry worldwide. The growth of packaging as a communication medium between a pharma industry and its customer, also plays a great role. The pharma industry should pay equal attention to packaging. Every time it can’t be looked as a cost to product, it should also be looked at as a brand building activity.

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✪ EDUCATION: GRADUATE IN CHEMISTRY FROM MUMBAI UNIVERSITY POST GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP (MUMBAI) ✪ CURRENT ORGANISATION: ALEMBIC PHARMACEUTICALS ✪ DESIGNATION: HEAD PACKAGING DEVELOPMENT & PROCUREMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 14.5 YEARS ✪ AWARDS & RECOGNITIONS: OPERATIONAL EXCELLENCE AWARD ‘MANTHAN AWARD’BY CHAIRMAN FOR TWO CONSECUTIVE YEARS DURING TENURE ATABBOTT HEALTHCARE ✪ PATENTS FILED, IFANY: CONTAINER FOR ORAL RECONSTITUTION PRODUCTS

ANAHITA KARANDE

22 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Worked on various innovative ideas such as pilfer proof pack for anti-cancerous injection product which won the Ameristar Award ● Contributed in team, right from idea generation to first pilot mold development of patented Container for Oral Reconstitution Products. Patients faced an issue in reconstituting and administering the medicine. This innovation helped overcome this concern, thereby giving customer satisfaction and achieving patient compliance through safe practices. This type of ‘Wow’ factor helps build trust for an organisation in the minds of patients while taking utmost care to produce products of highest quality ● Anti-counterfeiting blister pack: Automation in various packaging line for enhancement of productivity, like using concept of horizontal form fill seal for PS blister and strip pack in pouches

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PACKAGING IS THE FACE OFTHE PRODUCT AS WELLAS THE ORGANISATION TO THE CUSTOMER; HENCE INDUSTRIES SHOULD ALSO START INVESTING IN PACKAGING R&D

TRENDS IN PACKAGING Trends in packaging is generally moving towards digitalisation. It is giving rise to the development of smart packaging with faster turnaround time which calls for automation, standardisation and optimisation at every level, from manufacturing to distribution. Nowadays, with increase in customer awareness, they have become more demanding about aspects like authenticity and trust, convenience of usage and dispensing, wellness, sustainability and cost. With this shift, many companies are gearing up for automation at every level and are focussing to innovate customer-oriented packaging to keep pace with stringent regulation and cost effectiveness. The three major aspects of good packaging are:

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● Deliver products which comply with

regulatory, safety and quality standards ● Patient satisfaction and compliance ● Cost optimisation

CHALLENGES IN PHARMA PACKAGING Pharma industries are little reluctant to make the shift from conventional packaging to convenient and smart packaging. Many innovative ideas don’t materialise commercially due to constraints in cost effectiveness and subsequent changes required to be done in the manufacturing setup. Counterfeiting is also a real challenge for the pharma industry, it should encourage and adopt innovations to develop cost effective, anti-counterfeit solutions which would be difficult to replicate.

DRIVERS OF GROWTH Major drivers of growth will be fast understanding and faster adaptability of changing trends in the market, in line with patient needs. Take cognizance of latest technology to produce active and intelligent packaging which, along with all its functional properties, connects directly with customer for feedback and improvement. MESSAGE TO THE INDUSTRY Packaging is the face of the product as well as the organisation to the customer. Hence, industries should also start investing in packaging R&D to innovate on the material and the process front to improve on functionality and reach of packaging in terms of availability and cost effectiveness.

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✪ EDUCATION: EXECUTIVE PROGRAMME IN OPERATIONS AND SUPPLYCHAIN MANAGEMENTFROM ISB,HYDERABAD; PG DIPLOMAIN PACKAGING TECHNOLOGYFROM IIP,B PHARMACYFROM NAGPUR UNIVERSITY,PG DIPLOMA IN SCM,MATERIALS MANAGEMENT,EXPORT/IMPORT,MARKETING & LEAN SIX SIGMA BLACK BELTFROM LASSIB SOCIETY ✪ CURRENTORGANISATION: DR REDDY’S LABORATORIES ✪ DESIGNATION: DIRECTOR- SUPPLYCHAIN MANAGEMENT,HEAD GLOBALSOURCING (STRATEGIC AND PLANT) ✪ EXPERIENCE IN PHARMAINDUSTRY: 28 YEARS ✪ AWARDS & RECOGNITIONS ● INDIASTAR PACKAGING EXCELLENCE AWARD BYIIP,2010 ● OPERATION EXCELLENCE IN SUPPLYCHAIN BYUBM,2017 & 2016, AND OPERATIONALEXCELLENCE IN 2013 ATINDIAPHARMAAWARDS ● EXCELLENCE IN PATIENTENGAGEMENT,COSTIMPROVEMENT,PACKAGING MACHINERYAS WELLAS IN PACKAGING DESIGN BYUBM,2016 ATIPA ● PROCUREMENTEXCELLENCE AWARDS BYKAMIKAZE,2016 ● 'MOSTINNOVATIVE VENDOR MANAGEMENTPRACTICES' BYHMFI-IAM,2013 ● RECOGNITION FOR REDUCING WASTAGES IN PM BYASQ SOUTH ASIA

✪ PATENTS FILED,IFANY: PIC-INDIA: ARTICLE ON PHARMAPACKAGING,2015

AVINASH KUMAR TALWAR

24 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● The philosophy followed is CARE (Convenient – dosing information,Adhere- with pack size, Reassurance- prominent & permanent Expiry, Manufacturing & MRP details, Enable patient –ease of repurchase. Few innovations done are Drip Free Bottle and Cup, Critical information on Strip, and Blister. ● Foil with additional security features developed without changing its inherent nature or specification and yet provided an overt and covert anti counterfeit measures. ● Replaced wooden pallets by slip sheets to reduce carbon footprints ● Standardisation of shippers and foils

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INDIAN PHARMA INDUSTRY IS EXPECTED TO GROW OVER 15 PER CENT PER ANNUM. ITWILL SOON OUTPERFORM THE GLOBAL PHARMA INDUSTRY

TRENDS IN PHARMA PACKAGING ● e-Pedigree implementation. ● Providing counter and alert pack to patient. It will alert the patient for prescribed drugs. ● Reduction of uses of plastics by analysing the required headspace of bottle pack. ● Converting product information leaflets printed on paper to digitised, will result save tree and also reduced the cost. ● Assuring consistent quality, safety, compliance ● Cost effective, cold chain packaging solution- especially temperature and humidity exertion. ● Using automation as well as IOT to create smart pill and smart packaging. ● Providing cost effective and extended shelflife active barrier vials and blister pack. ● Providing low cost PEN to patient by using platform devices. ● Last mile friendly product packaging – especially pharma e-commerce. ● Institutionalisation of supply levers and smart designing. CHALLENGES TO PHARMA INDUSTRY ● Increased regulatory scrutiny has exposed

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compliance issues and chinks in good manufacturing practices ● Highly fragmented industry which causes instability; volatility and uncertainty ● Low margin of profits due to government pricing policies which creates market access barriers ● Low investment for research and development due to price pressure ● Intellectual property protection: Global innovators face price erosion in India due to this factor ● Consolidation of supply chain in the US market, resulting in pricing pressures OUTLOOK FOR THE PHARMA INDUSTRY The global pharma industry has been rated as a low risk industry, based on rise in demand due to growing middle classes and ageing population. It is recession proof and has a high level of profitability. Global pharma market will reach $1.12 trillion in 2022 with a growth rate of 6.3 per cent CAGR. This growth will be driven by $169 million additional sales in 2022 fromthe R&D pharma pipeline. At the same time there are challenges; over the past couple of

years, Indian drug manufacturers have come under intense scrutiny by the US FDA with respect to their manufacturing practices and quality standards. The Indian pharma industry is expected to grow over 15 per cent per annum. It will outperform the global pharma industry which is set to grow at an annual rate of five per cent. MESSAGE TO THE INDUSTRY Designing packaging which is very cost effective, is very important not only company’s perspective but also Society’s perspective. Because reducing cost reduces resource consumption and making it available for some other use. Sustainability shall be part of DNA of each packaging considering issues of global in nature like global warming, plastic pollution, etc. Keeping green sourcing concept in mind is very critical if carbon foot prints are to be reduced. Digitisation will drive the future so it is important to adopt this change as early as possible to remain competitive. Having said all this, customer is the king and he will remain as main focus of all that we do.

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✪ EDUCATION: M.SC (BIOCHEMISTRY), GRADUATION IN PACKAGING TECHONOLOGY FROM IIP, MUMBAI ✪ CURRENT ORGANISATION: SERUM INSTITUTE OF INDIA, PUNE ✪ DESIGNATION: SENIOR MANAGER-PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 22 YEARS (WORKED WITH WOCKHARDT, LUPIN LABORATORIES, SANDOZ IN PACKAGING DEVELOPMENT DEPARTMENT) ✪ AWARDS & RECOGNITIONS ● RECEIVED EIGHT SIGNIFICANT PERFORMANCE AWARDS FROM WOCKHARDT AND SANDOZ ● RECEIVED ASIA STAR AWARD FOR THE BEST DESIGN OF HDPE CONTAINERS

AVINASH ARVIND BALLAL

26 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Developed an innovative user friendly HDPE container and received India star, Asia Star and World Star Award in the year 2013 ● Investigated Benzophenone impurity leaches from the UV inks of sticker labels into pharma tablets and resolved this issue by using Aqua base Inks. ● Innovative container to help increase the sales of organisation and user friendly.

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FLEXIBLE PACKAGING AND COLD-CHAIN PACKAGING SEGMENT HAS WITNESSED SEVERAL CHANGES, IMPROVISATIONS AND INTRODUCTION OF INNOVATIVE PACKAGING SOLUTIONS

TRENDS IN PACKAGING Serialisation continues to be a driving force for change in the pharma packaging segment. A number of suppliers introduced technologies to enable serialised printing on primary packaging and even on finished dosages. New serialised labeling technologies on display included printing 2D barcodes directly onto vials and onto pills and capsules. While these technologies have been more widely adopted in Japan, they seem to be trending ever-increasingly in the Americas. A continuing challenge for drug manufacturers managing serialisation is the navigation of different standards within markets. A single, global serialisation standard continues to be an elusive moving target — even for neighbouring markets that exhibit only slight differences. This challenge continues to fuel the need for flexible equipment.For manufacturers producing medicines for multiple countries on a single processing line, serialised data needs to vary accordingly. New specialised software can

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manage this high level of complexity. It’s no surprise that we are seeing more processing software options to help manage and centralise serialisation efforts and reporting tools across printing and labelling, vision systems, robotics, etc. DRIVERS OF GROWTH Technological advancements such as holograms, RFIDs, labels and special inks designed to combat counterfeiting and tamper-evident packs along with strict government regulations on conventional packaging and a generic market that continues to expand. OUTLOOK FOR THE PHARMA INDUSTRY The sector has rebounded nicely from the underperformance of the past two years. New product sales ramping up, R&D success and innovation, strong results, a higher number of FDA approvals and continued strong performance from key products are some of the factors that could contribute to a sustained

recovery in the sector. Tax reforms and cash repatriation should also work in its favor. MESSAGE TO THE PHARMA INDUSTRY The Indian pharma industry is currently the third largest in the world and is one of the most developed industries. Technologically strong and self-reliant, the pharma industry in India has cost effective manufacturing, innovative scientific manpower, strength of internationally acclaimed laboratories, R&D capabilities and an increasing balance of trade. It is today ranked world class, in terms of, quality and range of medicines manufactured. From simple generic headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously. Complementing this, the flexible packaging and cold-chain packaging segment that has witnessed revolutionary changes, improvisation and introduction of innovative packaging solutions in the last four to five years indicating a bright future .

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✪ EDUCATION: POST GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP, MUMBAI; HONOURS GRADUATE IN CHEMISTRY, BURDWAN UNIVERSITY ✪ CURRENT ORGANISATION: DR REDDY'S LABORATORIES ✪ DESIGNATION: DIRECTOR PACKAGING DEVELOPMENT, DR REDDY’S LABORATORIES ✪ EXPERIENCE IN PHARMA INDUSTRY: 20 YEARS IN PHARMA PACKAGING ✪ AWARDS & RECOGNITIONS: NATIONAL SCHOLARSHIP FROM WEST BENGAL STATE GOVERNMENT, SCHOLARSHIP FROM IIP,VICE PRESIDENT OF IIP ALUMNI,ADVISORY COMMITTEE MEMBER WITH UBM INDIA & ACI, UK ✪ PATENTS FILED, IFANY: 2 US PATENTS

CONTRIBUTION TO INNOVATION IN PACKAGING ● Focussing on pharma packaging as a business enabler

BARUN DEY

● Focussing on pharma packaging as a differentiator in

business strategy ● Acting as an enabler in the packaging sustainable journey,

packaging digitisation, packaging automation etc

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CONTINUOUS INNOVATIONS IN PHARMA SUCH AS ANTI-COUNTERFEIT MEASURES, PRE-FILLED SYRINGES, CHILD-RESISTANT PACKS,AND OTHERS, ARE DRIVING MARKET GROWTH

OUTLOOK FOR THE PHARMA INDUSTRY ● DSCSA regulations will increase industry focus on serialisation, security and quality ● Greater consumer demand and increased focus on personalised care ● Rise in use of contract packaging companies ● Data management and cybersecurity will emerge as primary concerns ● Growing use of smart packaging for identification and patient engagement ● Accountability of pharma packaging manufacturers CHALLENGES IN PHARMA PACKAGING Globalisation: The push to globalise, to capitalise on huge marketplaces in rapidly developing nations - with this comes pressure to adhere to complex standards. Regulations: Developing and implementing superior processes related to rapidly evolving labels and new regulatory regimens for information and anti-counterfeiting.

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Economics: Downward price pressure due to broad governmental and economic factors is an ongoing challenge for the pharma packaging industry. New-product cost: A shrinking new-product pipeline, with fewer blockbuster drugs and increasing new-product cost. Speed-to-market: The need for speed-tomarket and agility to capitalise on short windows of exclusivity. Informed consumers: Sophisticated branding and product information are being implemented to pharma packaging to satisfy demanding OTC consumers and ever-moreinformed patients. Serialisation and usability: The requirement for a clear serialisation strategy driven by the falsified medicines directive — not only do patients need the correct medication without the risk of counterfeit products, they need to know how to use the packaging and have a clear understanding of how it works.

MESSAGE TO THE INDUSTRY The pharma packaging market in North America is expected to reach $29.24 billion by 2021, growing at a compound annual growth rate of nearly at five per cent during the forecast period, according to Technavio’s latest market study, Pharmaceutical Packaging Market in North America 2017-2021. Continuous improvements and innovations in the pharma industry such as anti-counterfeit measures, ampoules, pre-filled syringes, childresistant packs, and others, are driving market growth. The pharma plastic packaging market in North America accounted for the majority market shares during 2016 and is likely to experience a high growth rate during the estimated period as well. The pharma industry uses plastic bottles for storing liquid pharma products such as galenical medicines, readymade medicines and more. The growing demand for blister packaging will drive growth in this area.

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✪ EDUCATION: MASTERS IN PHARMACEUTICAL SCIENCES FROM BITS PILANI, DOCTORATE IN PHARMACY FROM KAKATIYA UNIVERSITY,WARANGAL ✪ CURRENT ORGANISATION: APOTEX RESEARCH, BANGALORE ✪ DESIGNATION: HEAD (VICE PRESIDENT), PRODUCT DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 21 YEARS (WORKED WITH DRL, NORBROOK LABORATORIES, UK, SM PHARMACEUTICALS, MALAYSIA, SMITH KLINE BEECHAM PHARMACEUTICALS, INDIA) ✪ PATENTS FILED, IFANY: 6 PATENTS FILED, SEVERALANDAS HAVE BEEN FILED TO VARIOUS REGULATORYAGENCIES ✪ ARTICLES/PAPERS PUBLISHED: 11 REVIEWARTICLES

DR SRINIVAS ARUTLA

30 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Been involved in end-to-end development of various pharma products. Innovation and creativity were integral parts of development process for more than 150 products, developed and commercialised in the course of his career. Made significant contributions to ensure: ● Assured supply of quality medicines to the customers ensuring their medical needs and safety. ● Thwart spurious/adulterated medicines ● Provide efficacious and quality medicines several market actions, recalls and other regulatory actions from various agencies have been avoided ● Reduce the usage of packaging materials to its minimum, wherever possible

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IT IS CRUCIALTO INTEGRATE KNOWLEDGE OF PRODUCT DEVELOPMENTWITH PACKAGING SCIENCE TO ENSURE PRODUCTS OF HIGH QUALITY

TRENDS IN PACKAGING As packaging is the first line of defense in fighting counterfeiting and safe transportation, recent trends in this area show a lot of emphasis in this direction. Prevention of counterfeiting and tampering is taking prime importance in packaging design. Assurance of product dispensing accuracy through precise design is another key area to ensure exact amount of dispensing, thereby assuring safety and efficacy of the product. Packaging design for brand identity and content reading through smart phones is another growing trend. Cost-effective, light weight and environment friendly packaging designs are also gaining a lot of importance. CHALLENGES IN PHARMA PACKAGING In the short term ● Ensure quality and safety of the product

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by optimising packaging design ● Ensure implementation of up to date regulatory requirements ● Eliminate waste in packaging development and optimise the cost In the long term qualified professionals with knowledge of formulation and packaging expertise ● Expertise in testing and quality assurance of critical packaging components ● Indigenous development of packaging equipment and components ● Cost-effective automation for all parts of packaging activity ● Developing

DRIVERS OF GROWTH Environmental friendly packaging, cost effective optimisations and recyclable packaging driven by technological

advancements is set to continue as drivers of growth. Cost efficient plastics and paper boards to reign the packaging segments. Packs to improvise patient compliance by ensuring dosing regimen will also play an important role. MESSAGE TO THE INDUSTRY It is crucial to integrate the knowledge of product development with packaging science to ensure products of high quality. Advancements in research and development of pharma products have always been dependent on packaging technology. Packaging will provide protection, identification, quality, patient comfort and needs of security. Maintaining integrity of pharma products during storage, shipment and delivery is assured by quality of packaging available which is key for safety, efficacy and success of product.

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✪ EDUCATION: SCIENCE GRADUATE WITH DIPLOMA IN PACKAGING TECHNOLOGY ✪ CURRENT ORGANISATION: HOSPIRA HEALTHCARE INDIA (A PFIZER COMPANY) ✪ DESIGNATION: GENERAL MANAGER ✪ EXPERIENCE IN PHARMA INDUSTRY: 25 YEARS (SERVED IN ORGANISATIONS LIKE AGIPI CHEMICALS, CHEMINOR DRUGS HIMALAYA DRUG CO, CADILA HEALTHCARE, ORCHID CHEMICALS AND PHARMACEUTICALS,TORRENT PHARMACEUTICALS, STRIDES ARCOLAB,WOCKHARDT,AND HOSPIRA HEALTHCARE INDIA)

GANESH KUMAR VALLURI

32 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Played a key role in introducing and developing Indian primary packaging material vendors in plastics and glass as import substitute for supplying to US market, thereby saving dollars and also making the world realise the potential and quality of Indian vendors ● Introduced double pallet stacking, thereby maximising the container utilisation, reducing carbon foot print. ● Established the systems and processes to ensure that the packaging quality and documentation meets the US market requirements ● Established serialisation lines across the network. The benefits of these endeavours were cost savings, import substitutions, dollar savings, ensuring potential and quality of Indian vendors known to the world, reducing carbon foot print, improving pharma packaging compliance and patient safety

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THERE IS GREAT POTENTIAL FOR INDIATO BE A PHARMA PACKAGING MANUFACTURING HUB FOR THE WORLD, PROVIDED THERE IS RESEARCH, INVESTMENTAND SKILL ENHANCEMENT

CHALLENGES IN PHARMA PACKAGING ● The quality systems and investments in pharma packaging material suppliers need to upgraded to meet the current demands. ● More research to reduce the amount of packaging used would make it more eco-friendly. ● Innovation hubs and startups in packaging are required. Sharing manufacturing platforms (cluster manufacturing), research base and serious involvement of government in developing research institutes like CSIR for packaging are needed to make India a packaging manufacturing hub for the world.

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Skill enhancement for the staff working in the packaging industry should be taken up, as most of the personnel working are based on experience and do not possess core knowledge. Awareness on careers in packaging and attracting niche talent to the industry like from IIT needs to be encouraged.

OUTLOOK FOR THE PHARMA INDUSTRY The pharma industry is challenged by increasing demand for quality, regulation, compliance, lowering of extractables and leachables, need to provide more clean components, and cost pressures as more

drugs are becoming generic. Packaging plays a significant role in lowering the costs and in meeting the stringent regulatory requirements. More established players should be entering into pharma packaging industry to provide innovation, research, volumes and cost competitiveness. Indian pharma packaging is challenged with lower skills and knowledge base in addition to cost competitiveness. There is great potential for India to be a pharma packaging manufacturing hub for the world, provided there is research, investment and skill enhancement.

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✪ EDUCATION: BSC, PHYSICS; INTENSIVE TRAINING COURSE IN PACKAGING TECHNOLOGY, IIP ✪ CURRENT ORGANISATION: GLENMARK PHARMACEUTICALS ✪ DESIGNATION: DEPUTY GENERAL MANAGER ✪ EXPERIENCE IN PHARMA INDUSTRY: 19 YEARS (WORKED WITH CIPLA, WATSON PHARMACEUTICALS, GLENMARK PHARMACEUTICALS)

HARPAL SINGH

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CONTRIBUTION TO INNOVATION IN PACKAGING Development of patient compliance packaging for complex SKUs like oral contraceptives and multiple cost improvement projects. These projects helped improve the costing of the products by way of savings in material and logistics. New innovative packaging designs were re-engineered for ease of use; ultimately resulting in reduction of market complaints as well.

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THE PHARMA INDUSTRY, FROM A PACKAGING TECHNOLOGIST’S POINT OFVIEW, IS GOING THROUGH ATRANSITION PHASE WHEREIN THERE IS A DEMAND FOR NOVELDRUG DELIVERYSYSTEMS AS COMPARED TO CONVENTIONALSYSTEMS

TRENDS IN PACKAGING The pharma industry, from a packaging technologist’s point of view, is going through a transition phase where conventional systems are being challenged and there is a heavy demand for novel drug delivery systems. Increasing volatility in the regulatory scenario is adding stress onto compliance preparedness which includes alignment of label designs to new and always changing guidelines. Patient-friendly packs like auto pen injectors, dialer packs, and digital actuators are few of the trends in packaging which, if observed carefully, are all patient centric and designed to provide

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the most convenient delivery systems for ease of use.

and trace requirements which are different for different geographies.

CHALLENGES IN PHARMA PACKAGING Differentiation in product designs and branding is the battle that is now being fought in the pharma packaging space amongst many others. This comes together with the challenge of minimising the cost impacts and maximising the compatibility of new equipment and designs. Hence, a cost effective, differentiated pack, which puts no additional stress on the controlled manufacturing capacity is the need of the hour. To add on to this are the woes and demands of the volatile and dynamic track

DRIVERS OF GROWTH There is a latest trend of app-based communication coming up which directly speaks to the patients and such new technologies by means of smart phones, will differentiate oneself from others and would be a driver for growth MESSAGE TO THE INDUSTRY As a pharma packaging technologist, the message is that whatever new dosage forms or delivery systems we are working on, let’s keep patient convenience in the forefront.

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✪ EDUCATION: B.SC (PHYSICS), PGDPT (IIP) ✪ CURRENT ORGANISATION: FORMER HEAD PDD (AGM PDD AND NPD PROCUREMENT) THEMIS MEDICARE ✪ DESIGNATION: CURRENTLYWORKING AS A CONSULTANT ✪ EXPERIENCE IN PHARMA INDUSTRY: THEMIS MEDICARE -4 YEARS -HEAD PDD AND NPD PROCUREMENT FOR REGULATED AND NON REGULATED MARKET) PLETHICO PHARMA- HEAD PDD- 7 YEARS (EXPORT /LOCAL MARKET / FOOD SUPPLEMENT ) FDC - 7 YEARS AS R&D PKGG EXECUTIVE WORKED AS SHIFT INCHARGE /PRODUCTION PLANNING SUPERVISOR FOR 3 YEARS IN ELECTRONICS INDUSTRY. COMPLETE SET UP OF PACKAGING DEVELOPMENT CELL IN THEMIS MEDICARE ✪ AWARDS & RECOGNITIONS: SPEAKER ATVARIOUS PACKAGING EVENTS AND FORUMS

JAYANTI SAWANT

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CONTRIBUTION TO INNOVATION IN PACKAGING ● Worked on sterile FFS eye drops and cartonator ● Worked on regulated market to ensure compliances ● Cost reduction for ORS ● System improvement and cost reduction ● Streamlined specifications for lozenges through stability. ● Worked on new mould for child resistant cap for liquid herbal syrup ● Creation of online database for 99 countries ● Complete set up of the packaging development at Themis Medicare These endeavours helped in brand development for sales benefit, contributed towards setting up a system for new product development with R&D.

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OVER THE LASTTWO DECADES, PACKAGING DEVELOPMENT HAS GROWN FROM TRADITIONAL TO COMPETITIVE PACKS WITH THE HELP OF EVOLUTION IN DIGITALAND OPERATIONAL TECHNOLOGYATVARIOUS LEVELS

TRENDS IN PACKAGING Over a period of almost last two decades, packaging development has grown from traditional packs to most competitive packs with the help of: ● Designing of artworks to availability of artwork software management systems . ● Printing technology upgradation – Which enhanced aesthetics and durability of the pack . For eg – better quality boards , holograms, 2d codes, e-pedigree (electronic document which provides data on the history of a particular batch of a drug. It satisfies the requirement for a drug pedigree while using a convenient electronic form. ) there by fascilitating many value added features like product safety , dispensing, anticounterfieting etc . ● Market requirements – As we expand on export front , regulatory compliances become mandatory ,there by , adding default features to the pack like -tamper evidence , child resistant , braille etc . Hence regulatory compliances and

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customer satisfaction are the measure needs of the pack. CHALLENGES IN PHARMA PACKAGING ● Stability of the product -product protection ● To hold and deliver the product to the ultimate customer - logistics and supply chain ● Cost optimisation – utilisation of available resources and deliver product with lowest possible cost. ● Create brand image as packaging is one of the Ps of marketing ● Alignment with regulatory compliances and support business development. ● Team management – develop and retain skilled personnel. DRIVERS OF GROWTH Growth of any industry is supported by many pillars. Most importantly, new technology. Team building through skilled staff (education and communication skills), adhering and

updating regulatory compliances and ensuring support resources to the development process are also very important. MESSAGE TO THE INDUSTRY From conventional pack to the modern pack, the journey of packaging development has been eventful. From holding the product to presenting the brand, ensuring product safety, being consumer friendly, support distribution channel, the field has today gained an identification of an extremely specialised field on technical, commercial and marketing fronts. The development technologists need to look into the features like market competition, costing, regulatory compliances, operational ease, aesthetics, consumer friendly, ecofriendly while developing the pack. This will support the product at all levels till it is consumed.

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✪ EDUCATION: GRADUATE IN CHEMISTRY FROM MUMBAI UNIVERSITY, POST GRADUATE IN PACKAGING FROM IIP, MUMBAI, DIPLOMA IN MANAGEMENT STUDIES FROM MUMBAI UNIVERSITYAND GRADUATE DIPLOMA IN MATERIALS MANAGEMENT FROM IIMM, MUMBAI ✪ CURRENT ORGANISATION: WOCKHARDT ✪ DESIGNATION: VICE PRESIDENT – GLOBAL SOURCING ✪ EXPERIENCE IN PHARMA INDUSTRY: 23 YEARS ✪ AWARDS & RECOGNITIONS: WELL RECOGNISED IN THE INDUSTRYAS A SUPPLY CHAIN AND PACKAGING PROFESSIONAL

CONTRIBUTION TO INNOVATION IN PACKAGING ● Generating substantial cost economies by using alternative packaging techniques without affecting the efficacy and performance characteristics in preserving the quality, potency and safety of pharma products.

JITENDRA JAYWANT JADHAV

● Improving the contribution of packaging to efficiency in logistics to optimise the overall supply chain cost. ● Helped industry in developing and implementing superior processes suited for rapidly evolving, new regulatory and quality regimens

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SMART PHARMA PACKAGING CAN HELP ENSURE THAT SHIPMENTS AND MEDICATIONS ARE ACCURATELYTRACKED AND SUPPLY CHAIN REMAINS FLUID, EFFICIENTAND COST EFFECTIVE

TRENDS IN PACKAGING Changes in pharma industry’s research and manufacturing technologies have driven significant development in packaging and delivery systems. The advent of new drug delivery systems and increase in the number of large molecules, biopharma drugs in development pipeline have resulted in the need for packaging which not only offers enhanced protection against factors such as moisture, light, oxygen and mechanical forces but also for packaging forms to play a more integral role in the drug delivery process. The packaging systems must ensure the potency of the drug, be tamper evident, help deter counterfeiting, promote compliance with a dosing regimen, ensure dosing accuracy, and be as safe, easy to use and as painless as possible. CHALLENGES IN PHARMA PACKAGING 1. Continuous pressure from government authorities to reduce medical treatment cost is indirectly putting pressure on reduction

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in packaging cost. 2. It is imperative for pharma manufacturers to design packaging which safeguard medicines against counterfeiting. 3. Compliance to various requirements of regulatory authorities has a direct bearing on package design. 4. Developing intelligent package designed to simplify communication between patient and doctors. 5. Rising popularity of new biological drug formulation continues to fuel some unanticipated packaging challenges. 6. Disruption caused due to digitisation in pharma industry will have huge impact on packaging used for medicines DRIVERS OF GROWTH Tracking shipment across the pharma supply chain is critical to ensuring product quality. Smart pharma packaging can help ensure that shipments and medications are accurately tracked and supply chain remains fluid, efficient and cost effective. When

applied to packaging, internet of things offers several advantages, including bidirectional communication, tracking and status display mechanisms. This is especially relevant where counterfeit drugs regularly enter the value chain. Tracking the movement of drug inventory at every point can potentially save supply chain participants billions of dollars. MESSAGE TO THE INDUSTRY Digitisation is disrupting the way business is performed across all industries and pharma packaging industry is no exception to it. Pharma digitisation and beyond the pill business transformations will affect the whole product life cycle, from R&D, packaging to product supply and patient care and eventually it will bring patients and their quality of life to the centre of the pharma business. Pharma packaging industry cannot ignore these changes and will have to get aligned to it to stay in business.

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✪ EDUCATION: SCIENCE GRADUATE, DIPLOMA IN PACKAGING FROM SIES INSTITUTE OF PACKAGING, MUMBAI INDUSTRIALTRAINING UNDER NCTVTTRADE APPRENTICESHIP : 1982 – 1985 ✪ CURRENT ORGANISATION: BIOLOGICAL E ✪ DESIGNATION: SR MANAGER – PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 28 YEARS (WORKED WITH HOECHST INDIA, CURRENTLY KNOWN AS SANOFI AVENTIS, RESTWORKED WITH RUSAN PHARMA, M J BIOPHARM,AUROBINDO PHARMAAND BIOLOGICAL E)

KIRANKUMAR LADEWAR

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CONTRIBUTION TO INNOVATION IN PACKAGING ● Improvements/development of packaging components as per regulatory and quality requirements ● Anti-counterfeiting/special features like hidden text/dual image introduced in printed packaging components for vaccine products ● Comprehensive experience in developing multi-functional, innovative, value added, cost effective, eco-friendly packaging solutions to meet various specific needs of customers. ● Improvement in the current packaging materials in terms of standardization, cost reduction and improving key functions and aesthetics ● New pack design with better aesthetic appeal for national and international markets. ● System improvement for simplification and robustness in processes ● Development of cold chain packaging to meet WHO requirements and other private market players

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CREATE DIFFERENTIATION IN PACKAGING TO GET BETTER MILEAGE. ENCOURAGE CULTURE OF INNOVATION TO MEET GLOBAL COMPETITION

TRENDS IN PACKAGING Within the next couple of years, more than 50 per cent of newly approved medicines will be biopharmaceuticals. They have a fragile nature: they are potentially very sensitive to enzymatic action in the manufacturing process and formulation. They are also highly complex protein molecules and their biological activity depends on their structural integrity. One of the major factors in maintaining the quality and integrity of biopharma/biosimilar is control of storage and transportation temperatures. Other major trends are: ● Marketing of products through internet ● Digitisation for customer convenience ● Shift from hospital administration to self

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administration - hence more devices DRIVERS OF GROWTH ● Global competitiveness in product/packaging costs ● Harmonisation of packaging for various markets ● Quick turn around time ● Customer-centric packaging CHALLENGES ● Meeting the threat from counterfeits ● Cold chain packaging up to end of the

chain ● Develop the pack to maintain the

temperature till destination with costeffective for commercial supplies

● Harmonisation of packaging to meet

various market requirements across the globe ● Meeting the ever increasing demand of regulatory requirements MESSAGE TO INDUSTRY ● Understanding the market requirements and incorporate necessary inputs in packaging ● Plan worst case studies during development by anticipating various challenges ● Create differentiation in packaging to get better mileage ● Encourage culture of innovation to meet global competition

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✪ EDUCATION: POST GRADUATE IN MBA, GRADUATE IN CHEMISTRY, GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY, DIPLOMA IN PHARMACY ✪ CURRENT ORGANISATION: MSN LABORATORIES ✪ DESIGNATION: HEAD, PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 16 YEARS (WORKED WITH DR REDDY'S LABORATORIES, NOVARTIS HEALTH CARE (SANDOZ),AUROBINDO PHARMA, MSN LABORATORIES) ✪ AWARDS & RECOGNITIONS : NUMEROUS BEST PERFORMANCE AWARDS FROM DR REDDY’S, NOVARTIS AND AUROBINDO PHARMA IN VARIOUS CATEGORIES

MANJUNATH NADELLA

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CONTRIBUTION TO INNOVATION IN PACKAGING ● Establishment of packaging guidelines for meeting regulatory requirements in terms of labelling and market trend ● Packaging standardisation like optimisation of primary, secondary and tertiary packs to increase productivity, meet customer timelines and requirements ● Optimum machine utilisation for productivity improvement and timely deliveries ● Cost effective projects for core areas of packaging to compete with global generics ● Product management for smooth execution of commercial launches

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A CREATIVE PACKAGE CAN SOMETIMES BE THE DRIVING FORCE OFAN ITEM.THE APPEARANCE COUNTS A LOT,WHEN IT COMES TO THE PACKAGING OFA PRODUCT

TRENDS IN PACKAGING The current trends in packaging are: Light and flexible packaging: The flexible packaging market is growing due to the many benefits, including recyclability and lightweight protection for all types of packaged goods. Creative package designs: Using customised shapes for packaging to complement a flavour or product use is a great way to leave a lasting impression on your consumers. Simple, clear and bold designs: There is an emphasis on creating simple and clean designs, which people can understand instantly. Such uncluttered designs are useful in sending out a brand message successfully to target audience. Unique shapes: Designers are experimenting with the packaging shapes to catch the eye of the potential customers immediately. CHALLENGES IN PHARMA PACKAGING Globalisation: The push to globalise, to capitalise on huge marketplaces in rapidly

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developing nations — with this comes pressure to adhere to complex standards. Regulations: Developing and implementing superior processes related to rapidly evolving labels and new regulatory regimens for information and anti-counterfeiting. Economics: Downward price pressure due to broad governmental and economic factors is an ongoing challenge for the pharma packaging industry. New-product cost: A shrinking new-product pipeline, with fewer blockbuster drugs and increasing new-product cost. Speed-to-market: The need for speed-tomarket and agility to capitalise on short windows of exclusivity. Informed consumers: Sophisticated branding and product information are being implemented to pharma packaging to satisfy demanding OTC consumers and ever-moreinformed patients. Serialisation and usability: The Falsified

Medicines Directive — not only do patients need the correct medication without the risk of counterfeit products, they need to know how to use the packaging and have a clear understanding of how it works. DRIVERS OF GROWTH Urbanisation, increasing health consciousness, increase in purchasing power, changing food habits etc. MESSAGE TO THE INDUSTRY First and foremost, it is basically the appearance of a product which grabs the attention of customers. Therefore, hard work and lots of creativity goes into great packaging. A creative package can sometimes be the driving force of an item. For e.g.; a significant and beneficial product wrapped up in paper and twine, may not generate great sales in the market. The appearance counts a lot, when it comes to the packaging of a product.

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✪ EDUCATION: GRADUATE IN SCIENCE FROM KAKATIYA UNIVERSITY. POST GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP. ✪ CURRENT ORGANISATION: CADILA HEALTHCARE (ZYDUS GROUP) ✪ DESIGNATION: SENIOR GENERAL MANAGER – PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 24+ YEARS (WORKED WITH DRL,TORRENT RESEARCH CENTRE, CADILA HEALTHCARE) ✪ AWARDS & RECOGNITIONS 50+ AWARDS IN PACKAGING EXCELLENCE AT NATIONALAND INTERNATIONAL LEVEL SUCH AS INDIASTAR,ASIASTAR AND WORLDSTAR. ✪ PATENTS FILED 32 DESIGN REGISTRATIONS FILED AT INDIAN PATENT OFFICE

MANOJ KUMAR TELUGUNTLA

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CONTRIBUTION TO INNOVATION Introduction of customer convenience features as per age, gender and targeted indications enhanced user experience. Implementation of latest brand protection features which are difficult to reproduce helps organisation and FDA to identify originality of product and fight against counterfeiting. Introduction of environment friendly packaging reduces consumption or elimination of plastic materials. Introduction of transit friendly packaging throughout lifecycle and till it reaches to end user very safely for very costly bio-similar and oncology products. Introduction of braille in blister pack for visually impaired people as a social responsibility.

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PACKAGING FUNCTION SHOULD CHANGE ITS IDENTITY FROM SERVICE PROVIDER TO REVENUE GENERATION FUNCTION,AND CONTRIBUTE TO TOP LINE AND BOTTOM LINE OF BUSINESS

TRENDS IN PACKAGING Change in consumer behaviour, lifestyle, price and increased awareness changing the decision at the point of sale. Packaging systems that offers enhanced user experience, assuring its quality and authenticity without extra cost is order of the day. All pharma companies are forced to automate their processes to meet various regulatory and serialisation requirements impacting the profitability of business, therefore selection of total packaging system right from stability studies to commercialisation has to be highly cost conscious and manufacturing friendly. CHALLENGES IN PHARMA PACKAGING Change in hospital administration process to self-administration process increasing, therefore clear communication of product usage, simplification of packaging system and high compliance is key to the success of product. As complex formulations and bio-

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similar products launches are increasing, identification of right materials for successful stability and supporting for commercialisation on time is big key to the success. Continuously upgrade packaging system and differentiate it with advanced technology of security features at fixed intervals to protect the brand from counterfeiting and health hazards of user. DRIVERS OF GROWTH Offering customised packaging solutions, engaging and educating patients about product usage, safety, availability and authentication through packaging with the help of IT applications, digital printing and ecommerce build the relations with users, improves the loyalty and sales are sustained. ● Continuously look for alternate opportunities of packaging materials and concepts that offer similar properties of product performance and stability, harmonization / standardisation of artworks, ●

specifications, change parts and materials so that overall packaging cost is optimum. Packaging has the power to influence overall business by means of product differentiation, operational excellence and supply chain. ● Take feedback and insights from doctors, users and trade about current performance and improvements required in packaging, and bring them into existence proactively before users shift to other brand. MESSAGE TO THE INDUSTRY Continuously focus on challenges and opportunities that enhance user convenience and safety to improve performance of product through packaging. Cost of the packaging has to be optimised during stability studies stage only. Design total packaging system considering harmonisation and standardisation of processes, materials and availability so that product launches are with high efficiency.

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✪ EDUCATION: MBA IN INTERNATIONAL BUSINESS, POST GRADUATE DIPLOMA IN PACKAGING ✪ CURRENT ORGANISATION: GLAND PHARMA ✪ DESIGNATION: SR. MANAGER ✪ EXPERIENCE IN PHARMA INDUSTRY: 12 YEARS

MUNINDRA ROY

46 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING Innovation Award Winner in Sentiss by extending product shelf life. Also, developed functional labels for light sensitive products, new design layouts for PFS products. A lot of cost savings were done through the innovations done as well as many of the processes were simplified.

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PEOPLE ARE INCREASINGLY SHOPPING ONLINE AND MARKETERS NEED TO THINK ABOUT HOW PACKAGING FUNCTIONS ARE SEEN ONLINE,AT HOME AND THROUGHOUTTHE DELIVERY PROCESS

TRENDS IN PHARMA PACKAGING Packaging that is intelligent and interactive: Packaging that allows consumers access to more information on a product through their smartphone Unification of package structure and branding: When a structure can help to form and support your brand identity it gives shoppers a reason to further engage with your package. The role of online packaging: People are increasingly shopping online and marketers need to think about how packaging functions are seen online, at home and throughout the

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Price competition

delivery process.

DEMANDING ASPECTS OF PHARMA PACKAGING ● Packaging of new drugs ● Meeting serialisation requirements ● Bringing innovation so that brand value gets enhanced

OUTLOOK FOR THE PHARMA INDUSTRY The industry is growing at a compound annual growth rate (CAGR) of 4-7 per cent to 2018 and reach $1.3 trillion as per estimates of IMS. Also, according to estimates from IMS, gradually there will be a rise in the spending of speciality medicines. There will also be an increase in uptick in the number of approvals of new molecular entities (NMEs) by the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER). Spending on new brands will also increase.

CHALLENGES IN PHARMA PACKAGING ● Compatibility of packaging and product ● Understanding regulatory requirements ● Safety requirements ● Tamper evidence and serialisation

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✪ EDUCATION: B.TECH (MECH), PGD-PLASTICS ✪ CURRENT ORGANISATION: SUN PHARMA ✪ DESIGNATION: SENIOR GENERAL MANAGER ✪ EXPERIENCE IN PHARMA INDUSTRY: 20.5 (NEARLY 18 YEARS IN DR REDDY’S LABORATORIES AND 2.5 YEARS IN SUN PHARMACEUTICALS) ✪ AWARDS & RECOGNITIONS: MORE THAN 50 AWARDS ON GLOBAL PLATFORM IN VARIOUS CATEGORIES OF PACKAGING AND MACHINERY ✪ PATENTS FILED, IFANY: 10 JOINT PATENTS FILED,WITH THE ORGANISATION

P SRINIVAS NAIDU

48 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING Pharma Packaging/Device Design is a culmination of several important parameters like customer needs, functional properties, logistic requirements, machinability, display values, ease of use (Intuitiveness), sustainability, statutory requirements, value addition to supply chain partners etc. “Human Centric Design, frugal innovation, statutory requirements , ergonomics , aesthetics” are key parameters of all my designs and developed various devices and packaging components which helped in bringing new products to the market at affordable price. Developed several simulation models based on “Design space & QbD” to reduce the overall development cycle time lines of complex drugs for regulated markets.

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PACKAGING SECTOR IN INDIA IS STILL IN EVOLVING PHASE AND IT IS THE TIME FOR CONSOLIDATION AND TO FOCUS ON BRINGING NEW CONCEPTS TO CATER UNMET NEEDS OF OUR COUNTRY

TRENDS IN PHARMA PACKAGING Packaging sector in India is still in evolving phase and it is time for consolidation and to focus on bringing new concepts to cater unmet needs of our country. With abundant IP capability in India, it is time to focus on indigenisation and to increase our share in developing high end drug delivery devices for global markets. Pharma companies should start focussing on the sustainability aspect while designing

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packaging as majority of packaging material used in pharma cannot be reused in any form. OUTLOOK FOR THE PHARMA INDUSTRY India enjoys an important position in the global pharma sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level. Pharma companies will continue to grow both

organically and inorganically through alliances and partnerships and will continue to focus on improving operational efficiency and productivity. The growth of Indian pharma packaging industry is directly linked to growth of pharmaceutical manufacturing industry. Pharma packaging industry in India is expected to be worth $2.60 billion by 2020. India enjoys an importas expected to beed to grow at a CAGR of 5.46 per cent till 2020.

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✪ EDUCATION: POST GRADUATE IN ECONOMICS, DIPLOMA IN PHARMACEUTICAL PACKAGING ✪ CURRENT ORGANISATION: PIRAMAL ENTERPRISES ✪ DESIGNATION: LEAD PACKAGING DEVELOPMENT R&D ✪ EXPERIENCE IN PHARMA INDUSTRY: 16 YEARS (SERVED IN RANBAXY LABS, MATRIX LABS, KEMWELL BIOPHARMA) ✪ AWARDS & RECOGNITIONS: RECOGNISED PHARMA PACKAGING PROFESSIONALWITH EXPERTISE IN COMMERCIAL LABELLING AND PACKAGING

PARAS JAIN

50 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Expertise in implementation and execution of pharma serialisation to ensure compliance ● Operational excellence in packaging machines ● Set up of packaging R&D departments and commercial packaging ● Developed dropper safety plug to ensure packaging automation and avoid contamination for end user

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AS A PACKAGING PROFESSIONAL, ONE SHOULD ALWAYS STRIVE TO GIVE OUR PATIENTS WHATTHEY EXPECT,WHEN THEY EXPECT IT – EVERYTIME!

TRENDS IN PACKAGING Pharma packaging plays a significant role in maintaining drug product quality and promoting safe and effective use of lifesaving and life-sustaining medicines. It is not so easy to select packaging materials in the mission for efficient product protection, machinability, regulatory standards, supply chain management and end user safety. Rapid changes in technologies and adopting them into the existing system is also becoming challenging. In the pharma packaging sector, hot topics are being discussed, i.e. regulatory compliances (specially USP 40 Chapter <661>), FDA’s new labelling guidelines, serialisation, patients compliances, supply chain module, vendor networking, anti-counterfeit, packaging component qualification and validation. Packaging design melds shapes, graphics, materials and more to create functional packaging that appeals on many sensory levels: visually, tactilely, emotionally yet cost effective and within the compliance.

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CHALLENGES IN PHARMA PACKAGING Packaging professionals require understanding of the challenges in the pharma packaging sector. As technologies and regulatory laws are updating, many new challenges are being imposed on the sectors. The challenges are in: ● Impact on production/operations workflows ● Pharmacopeia upgradation ● Reducing packaging and labelling errors ● Implementing pharmaceutical serialisation ● Correcting line issues and machinery jams ● Reject handling and rework ● Additional procedural controls and SOPs ● Fighting counterfeiting ● Patients compliances ● Packaging waste management ● Risk assessment and risk mitigation DRIVERS OF GROWTH In the coming year, pharma packaging professionals will see even more tools evolve to help them identify new innovative

technologies as well as streamline their existing packaging mechanism. The struggles and everyday challenges of pharma packaging and labelling should be handled diligently. Considering modern regulatory compliances, product life cycle management and consumer exceeding expectations, applying of Quality by Design concept in the packaging development is essential. MESSAGE TO THE INDUSTRY As a packaging professional, one should always strive to give our patients what they expect, when they expect it – every time! Packaging professionals should stimulate development creativity in companies as product innovations with packaging that is consistent and impactful, innovative, and of high-quality, is what makes them stand out. Packaging professionals should be committed to contributing to the society by developing and providing proprietary, valueadded components that will exceed end user satisfaction.

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✪ EDUCATION: PG DIPLOMA IN PACKAGING TECHNOLOGY FROM INDIAN INSTITUTE OF PACKAGING, MUMBAI (18TH BATCH) IN 2004 B. PHARMACY FROM MAHARASHTRA COLLEGE OF PHARMACY, NILANGA, MAHARASHTRA IN 2002 ✪ CURRENT ORGANISATION: SRI KRISHNA PHARAMACEUTICALS, HYDERABAD ✪ DESIGNATION: MANAGER, PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: OVER 10 YEARS (WORKED WITH SRI KRISHNA PHARMA, SUN PHARMA, FERRING INTERNATIONAL PHARMA SCIENCE CENTRE, DR REDDY’S LABS,TORRENT RESEARCH CENTRE)

PAVANKUMAR S PATIL

52 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Team member of ‘Best innovative team - Red Heart Pill (RHP)’, awarded during chairman award function at Dr Reddy’s Laboratories, Hyderabad - Jan 2007 ● Developed pack & packaging system for randomised double blind clinical trial study. The pack was been used in eight countries for clinical trials ● Developed secondary packaging lines for auto injector pen, infusion bags, nasal spray and aerosols consist of robotic feeding system and cartoning machine ●Hand on development of change-parts on blister packaging machine, cartoning machine and bottle filling machine and also validated them ●Hand on development of packaging material and packaging process for ‘Lyophilised Mouth Dissolving Tablet ● Streamlined the packaging development laboratories and systems meeting the international standards with best of the equipments and systems to meet ever demanding requirements of the US, Europe, ROW and domestic markets

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PACKAGING TECHNOLOGIST IS BOUND TO DELIVER COST EFFECTIVE SUSTAINABLE PACKAGING SOLUTION WHICH WILL FULFILL PATIENT COMPLIANCE AND DRUG SAFETY

TRENDS IN PACKAGING As digitalisation and social media adaptability spread awareness about patient safety and compliance. Day to day new updates on labelling and patient compliance force to change routine packaging design. Upgraded dosage form and drug delivery systems are key reason that packaging technologist need to think out of box for packaging design. Proposed systems shall be comply quality, safety, security, product stability and productivity.

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CHALLENGES IN PHARMA PACKAGING 1. Balancing between patient compliance and productivity using available resources and facility 2. Awareness amongst brand owners for need of suitable Packaging 3. Co-ordination and training within team consisting of quality, regulatory compliance and production team to deliver cost effective and quality product to society. 4. Feedback and training to community health professional to improve design of Packaging where drug dose regiment is much more important

DRIVERS OF GROWTH 1. Awareness amongst patients and health professionals force to upgrade packaging design to fulfill patient compliance. 2. Improvement in supply chain and good distribution practices through imposed laws around globe forced to check packaging as key drive to comply all aspects MESSAGE TO THE INDUSTRY Packaging technologist is bound to deliver cost effective sustainable packaging solution which will fulfill patient compliance and drug safety..

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✪ EDUCATION: HONORS GRADUATE IN CHEMISTRY FROM CALCUTTA UNIVERSITY ; POST GRADUATE IN PACKAGING FROM IIP, MUMBAI ✪ CURRENT ORGANISATION: MYLAN LABORATORIES ✪ DESIGNATION: HEAD, PACKAGING TECHNICAL SERVICES (OSD, INDIA) ✪ EXPERIENCE IN PHARMA INDUSTRY: 27 YEARS IN PHARMA INDUSTRY (APPROXIMATELY 19 YEARS IN RANBAXY LABORATORIES AND REST IN MYLAN LABORATORIES) ✪ AWARDS & RECOGNITIONS: WELL RECOGNISED IN THE INDUSTRYAS A PACKAGING PROFESSIONAL

PRABIR KUMAR DAS

54 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Improvements in packaging standards in compliance with regulatory and quality requirements. Helped the industry to adopt and adapt new processes and systems in compliance to contemporary regulatory and quality requirements. ● Execution of new processes and systems from lab scale to large scale mass production through automation, standardisation and harmonisation. ● Helped build business abilities to compete in global market with quality excellence and cost effectiveness

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PACKAGING CONNECTS THE PRODUCTWITH THE PEOPLE. SO, IT IS IMPORTANTTO UNDERSTAND THE PRODUCT, UNDERSTAND WHAT PEOPLE WANT AND UNDERSTAND THE PROCESS

TRENDS IN PACKAGING A trend change from conventional pack style to convenient and smart packaging has been observed, efficiently backed up by operational changes from manual to semi-automatic or fully automatic packaging lines. They help in not only scaling up volume, but also in reducing variability and improving consistency in quality and compliance. Various technologies are blending to assist automation through standardisation and harmonisation of packaging designs and systems. On line processes are being designed to ensure stronger controls and compliances. A combination of mechanical-electrical-optical engineering and introduction of digital electronics has brought technological revolution in various conversion industries, including packaging. All these technologies are being adopted and adapted to ensure improvement in productivity, quality, stability, safety and security. With this rapid and unconventional growth of the industry, a parallel threat has also grown to tarnish the trust of people on successful products/brands.

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Many value added features then appeared and were embedded in packaging to prevent tampering, theft, duplication, diversion, etc. On the compliance front, there came child resistant features, senior friendly features, punctuality compliant features, easy dispensing features, age-band specific designs, and many others based on dynamic, regulatory and customer compliance needs. CHALLENGES IN PHARMA PACKAGING In the short term ● Design and development of the best packaging option to ensure product stability and maintain quality ● Alignment with regulatory guidelines to maintain business continuity ● Cost optimisation to compete in the market ● Training and skill development of people In the long term ● Maximising automation at all levels of packaging ● Harmonising specifications and standardising processes ● Backward integration and indigenisation

of materials and equipment ● Developing dedicated team of packaging professionals DRIVERS OF GROWTH Digitisation and communication will be two major drivers in all sectors from development to distribution. Services will be equally important as goods and consumer expectations will be as dynamic as ever, along with regulations to safeguard public health. All layers of the industry need to get true professionals to channelise resources for critical functions and allocate sufficient provisions to adapt quick changes. MESSAGE TO THE INDUSTRY Packaging connects the product with the people. So, it is important to understand the product, understand what people want and understand the process – how people can easily access the product and how can packaging help facilitate it by applying knowledge on material and technology, rules and regulations, logistics and distribution, economy and environment.

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✪ EDUCATION: MSC MICROBIOLOGY ✪ CURRENT ORGANISATION: UNICHEM LABORATORIES ✪ DESIGNATION: HEAD, PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: MORE THAN 34 YEARS (WORKED IN USV, PROCTER & GAMBLE,JOHNSON & JOHNSON, KOPRAN ETC) ✪ AWARDS & RECOGNITIONS: SOLITARYASIAN TO SPEAK ATTHE 6TH ANNUAL PHARMA PACKAGING & LABELLING CONFERENCE AT AMSTERDAM,THE NETHERLANDS SPEAKER AT INTERNATIONAL BUSINESS CENTRE AT SINGAPORE ✪ ARTICLES/PAPERS PUBLISHED: ARTICLES PUBLISHED IN EXPRESS PHARMA ON ‘WHAT’S IN A LABEL?’AND ON ‘CHALLENGES ON TRACK & TRACE IN SERIALISATION’

PRADEEP A DHARGALKAR

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CONTRIBUTION TO INNOVATION IN PACKAGING Without intervention of principal regulatory departments such as regulatory affairs, quality assurance, with the help of packaging development team at various stages, has driven the activity of keeping artworks updated to the regulatory requirements of this land

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PACKAGING IN PHARMA IS PROGRESSING IN A DIRECTION OF CONFIDENCE BUILDING AND SEAMLESS FLOWACROSS CHANNELS OF DISTRIBUTION

TRENDS IN PACKAGING In the last eight years, there has been an emphasis on packaging as a medium for vouching authenticity. Track & Trace measures, postulated and enforced by markets, with GS1 Worldwide Guidelines as backbone are welcome steps to impede the nefarious intentions of a ‘counterfeiter’. This ensures confidence building through channels of distribution. It builds synergy across markets. The overall benefit is that the product from a bonafide manufacturer reaches the end-user. The end-user or the healthcare professional also has the confidence and surety that if the product is not up to the claimed standards,

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backtracking with supporting back-up to support the claim/query can be pursued through the enforcing/regulatory agencies, so as to ensure that the complaint/query reaches the specific level for redressal. In short, packaging in pharma is progressing in a direction of confidence building and seamless flow across channels of distribution. CHALLENGES IN PHARMA PACKAGING In the short term Minimal friction transition to US serialisation activity and work on the synchronising activity in line with serialisation and TE needs of Europe market.

In the long term Minimal, just sufficient packaging so as to aid in efforts to contain the rate of adverse effects on environment and to lower the packaging material cost impact DRIVERS OF GROWTH To be updated with the wherewithal so as to be able to implement the requirements of a market as soon as the regulation is enforceable, gives the ‘early bird’ advantage to consolidate market standing. MESSAGE TO THE INDUSTRY Industry has to be far ahead in terms of innovations and anti-counterfeit features.

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✪ EDUCATION: M.SC. (CHEMISTRY), MBA (OPERATIONS), GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY (FROM SIES MUMBAI) ✪ CURRENT ORGANISATION: LUPIN R&D AURANGABAD ✪ DESIGNATION: RESEARCH SCIENTIST (PACKAGING DEVELOPMENT – DOMESTIC AND ROW MARKET) ✪ EXPERIENCE IN PHARMA INDUSTRY: 13 YEARS (WORKED WITH ORGANISATIONS LIKE AJANTA PHARMA, GLENMARK PHARMAAND NOW WITH LUPIN PHARMA) ✪ AWARDS & RECOGNITIONS : ● HONORED ‘BATCH TOPPER’IN GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY, BY SIES SCHOOL OF PACKAGING ● CERTIFICATE TRAINING COURSE IN 'PACKAGING OF PHARMA PRODUCTS' CONDUCTED BY IIP HYDERABAD ● CERTIFICATE TRAINING COURSE IN 'DEVELOPMENTAND QUALITY CONTROL OF PLASTICS' CONDUCTED BY CIPETAURANGABAD

PRAFULLV. DESHPANDE

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CONTRIBUTION TO INNOVATION IN PACKAGING Worked with the primary packaging material which is in direct contact of various drug formulations like solid orals, ophthalmic, oral liquids, injectable etc. where packaging needs to be considered as per the product behaviour/requirement. Not only packaging material, machine parts also needs to choose/considered as per product requirements. Innovative and cost effective approach right from product development stage which minimises many issues/reworking while and after product commercialisation. This approach helped me a lot while working to reduce organisational packaging reworking on same projects

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IN THE ERA OF GLOBALISATION, ITWOULD BE A CHALLENGE FOR THE PHARMA PACKAGING INDUSTRY,AS THE YEARS AHEAD WOULD WITNESS THE OPENING OFTHE GLOBAL CHANNELS

DEMANDING ASPECTS OF PHARMA PACKAGING Traditionally, the majority of medicines (51 per cent) are being taken orally, through tablets or capsules, which are either packed in blister packs (very common in Europe and Asia) or fed into plastic pharma bottles (especially in the US). Powders, and liquids also make up part of the oral medicine intake. However, other methods for taking medicines are now being more widely used. These include parenteral or intravenous (29 per cent), inhalation (17 per cent), and transdermal (3 per cent) methods. These changes have made a big impact on the packaging industry and there is an increasing need to provide tailored, individual packaging solutions, which guarantee the effectiveness of medicines. I majorly focus on the significant aspects of packaging vendors, to revisit their documentation/TDS part w.r.t. current regulatory pharma packaging requirement.

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Many packaging suppliers are not aware about the current pharma packing requirements. Now in IP 2018, standard tests for pharma packaging material has been added. It needs to be evaluated and supposed to be implemented in their TDS/specifications. Also, extractable and leachable part needs to be evaluated. Due to lack of effective documentation practices among many indigenous packaging vendors, we unwillingly need to approach overseas vendors, which has high lead time and cost. OUTLOOK FOR THE PHARMA INDUSTRY In the era of globalisation, there would be several challenges for the pharma packaging industry, as the years ahead would witness the opening of the global channels. To match international standards and quality attributes, it is necessary that packaging industry upgrades itself in research for a

realistic approach towards packaging development that would go beyond the functional aspects of pharma packaging. Presently, very few pharma companies spend time and money on R&D in packaging. The conventional packages available do not serve the purpose of providing protection against counterfeiting and quality, and the industry seems to be sluggish in adopting technical advances in packaging, probably on account of the prohibitive cost factor. As the packaging industry is directly or indirectly involved in the drug manufacturing process, it becomes ethically mandatory to understand and incorporate advanced scientific methods in packaging. Pharma packaging industry is on the verge of rapid growth, driven by innovation as it serves various needs of the product, ensure its security, and enable cost and patient convenience. It is also playing an important role in building brand identity.

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✪ EDUCATION: BACHELOR IN SCIENCE, MUMBAI & CERTIFICATE COURSE FROM INDIAN INSTITUTE OF PACKAGING, MUMBAI ✪ CURRENT ORGANISATION: AUROBINDO PHARMA ✪ DESIGNATION: ASSOCIATE VICE PRESIDENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 17 YEARS (WORKED WITH M.J BIOPHARM, GLENMARK PHARMACEUTICALS, FAMY CARE, AUROBINDO PHARMA) ✪ AWARDS & RECOGNITIONS: WELL RECOGNISED AS A PACKAGING PROFESSIONAL FOR LASTTWO DECADES

PRASAD GHANSHYAM SATAM

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CONTRIBUTION TO INNOVATION IN PACKAGING ● Spearheading the packaging development function at R&D. ● Global role in packaging development of various dosage forms for regulated and semi-regulated markets. ● Playing a major role from research development till approval of product and contribution in new product launches. ● Support to operations in identifying packaging machines and defining the scope. Device development for sterile products. ● Designing of child resistant blister packs to comply meeting standard set forth by CPSC in 16 CFR 1700. ● Safe packaging for customer enabling market expectation and business needs

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NEED TO TRAIN HEALTHCARE PROFESSIONALS FOR REDUCING ERRORS AND USAGE OF PACKAGING SYSTEM IN RIGHTWAYTO GIVE ACCURATE RESULTS

DEMANDING ASPECTS OF PHARMA PACKAGING In the short term ● Regulatory and compliance related challenges due to frequent packaging components related changes in pharmacopeial revisions. ● Packaging development strategy to receive fastest regulatory approvals of product and ultimately fast commercial launches. ● Simulation of packaging operation from exhibit to commercial stage. In the long term ● Alternate material of construction for

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primary packaging components. e. g. Alternate of PVC blisters and HDPE bottles for solid orals, tablets and capsules. ● Local sourcing of packaging components for regulated markets complying regulatory requirement. e. g. low migration inks, glass pre - filled syringes, rubber stoppers, cartridges, plastics vials and prefilled syringes etc. ● Eco friendly packaging – reduce, re-cycle and re-use. OUTLOOK FOR THE PHARMA INDUSTRY adherence through user friendly

● Patient

packaging. ● Self-medication - Trend in use of pen devices and auto injectors. ● Growth in usage of OTC drugs. ● Higher expectation from regulatory and government agencies. ● Increasing completion in generic market and expectation of cost effective packaging. ● Need of training to healthcare professionals for reducing errors and usage of packaging system in right way to give accurate results. ● Child resistant, senior friendly, reminder packs and anti-counterfeiting

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✪ EDUCATION: SCIENCE GRADUATE WITH ADDITIONAL QUALIFICATION IN PACKAGING TECHNOLOGY (IIP, MUMBAI) AND PLASTIC TECHNOLOGY (IPI, MUMBAI), PG DIPLOMA IN INTELLECTUAL PROPERTY RIGHTS (NALSAR, HYDERABAD) ✪ CURRENT ORGANISATION: AUROBINDO PHARMA ✪ DESIGNATION: DEPUTY GENERAL MANAGER ✪ EXPERIENCE IN PHARMA INDUSTRY: 22 YEARS (WORKED WITH PFIZER, AUROBINDO PHARMA,ASPEN PHARMA,WOCKHARDT PHARMA ETC) ✪ AWARDS & RECOGNITIONS INDIA STAR AWARD,ASIA STAR AWARD FOR DEVELOPMENT OF INNOVATIVE CALENDAR PACK FOR US PRODUCTAND SHELF READY DISPENSING PACK GOLD STAR SOUTH AFRICAAWARD FOR INNOVATIVE DESIGN OF COSMETIC PRODUCT

CONTRIBUTION TO INNOVATION IN PACKAGING ● Development of innovative calendar pack for US product and shelf ready dispensing pack

NARLANKA PRAVEEN KUMAR

● Worked on innovative design of cosmetic product ● The customer friendly packaging demonstrated an innovative method and the contents used are 100 per cent eco-friendly and recyclable packaging material.

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OFTEN, IN THE PROCESS OF DESIGNING PACKAGING MATERIAL,WE DO NOT CONSIDER ERGONOMICS AND FACE SUBSEQUENT CHALLENGES THROUGHOUTTHE PROCESS I.E. PACKING, DISTRIBUTION AND LOGISTICS

SIGNIFICANT ASPECTS OF PHARMA PACKAGING In recent times, major focus and contribution has been on the following four areas. ● Automisation: For consistent quality and timely delivery compliance one has to maximise efforts in automisation. We have been doing this on two areas of packaging, at secondary level and tertiary level, which were neglected earlier. ● Countering falsified medicines: Every country wants to get rid of duplicates which are creating a huge deficiency in quality of medicines and also denting the exchequer. The Indian government wanted to implement DGFT which requires printing serialisation details on packaging components. And similarly, many countries are coming up with requirement such as DSCSA for US and EUFMD for EU countries. This requires change in the design of primary, secondary and tertiary packaging

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materials, packaging lines etc. ● Redefine packaging with optimised

design: To be in competition, one needs to continuously redefine their approach and look for opportunities. With limited scope in product, it is always packaging material, which can generate revenues, if properly addressed. A penny saved is penny earned. ● Backward integration: This is one opportunity that many companies do not explore, but it has its own advantages and disadvantages. Our company has been principally focussing on a few components, and have majorly achieved success in quality and timely deliveries. As packaging and plastic technologists, we did play a major role. CHALLENGES IN PHARMA PACKAGING Often, in the process of designing packaging material, we do not consider ergonomics and face subsequent challenges

throughout the process i.e. packing, distribution and logistics. It is utmost important that the packing is designed ergonomically, be it primary, secondary or tertiary packaging. If product packaging is not designed appropriately, companies will face challenges in regulated markets at a later stage and may have to rework on their packaging. In any company, for commercial viability, the product needs to be packed with complete automisation. This would reduce manual errors and inconsistencies in quality, quantity and delivery. MESSAGE TO THE INDUSTRY ‘Right First Time’ should be the mantra. Many neglect the importance of packaging at the beginning. However, we should remember that right packaging is the first sales point of the product.

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✪ EDUCATION: B.SC. PG DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP (DISTANT) ✪ CURRENT ORGANISATION: AUROBINDO PHARMA ✪ DESIGNATION: GENERAL MANAGER – PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: OVER 30 YEARS (WORKED WITH ORGANISATIONS LIKE RANBAXY, NATCO,ACTAVIS,AUROBINDO) ✪ AWARDS & RECOGNITIONS: OUTSTANDING PERFORMANCE RATING IN ALL ORGANISATIONS. REGULAR SPEAKER AT REPUTED EVENTS AND CONFERENCES ON PHARMA PACKAGING ✪ PATENTS FILED, IFANY: DIPI HALER, DEVELOPED AND PATENTED ON BEHALF OF NATCO PHARMA FOR DRY POWDER INHALATION CAPSULES ✪ ARTICLES/PAPERS PUBLISHED: CONTRIBUTED TO IN-HOUSE MAGAZINES

R CHANDI PRASAD

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CONTRIBUTION TO INNOVATION IN PACKAGING ● Streamlined department functions into system oriented, simplified processes and in compliance with regulatory and statutory requirements to ensure correct interpretation and completely eliminate overdoing in packaging. ● Abreast of technological development in materials and machinery. ● Labelling compliance in pharma industry is ever challenging. ● Packaging in the culture of the country and regional where the products are consumed besides the regulatory requirements.

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WE NEED TO SHIFT FOCUS TO PATIENT COMPLIANCE AND MAKE USER FRIENDLYPACKAGING FOR INFORMATION AND USAGE, DOSAGE ALERTS AND ACCURATE DOSE DELIVERYSYSTEMS

TRENDS IN PACKAGING A major role will be played by packaging technologists in the pharma industry to completely remove over-packaging. They will have to rid themseves of the imitator mindset and use their experience in optimising packaging to suit the requirements of dosage, route of administration and climatic conditions of the country of export. They will implement latest technological advancements in every sphere of packaging materials and machinery automation. CHALLENGES IN PHARMA PACKAGING In the short term ● Pharma products require standards in packaging which is superior to that of most other products in terms of proven efficacy, safety, uniformity, integrity, purity with limited impurities and shelflife stability profile. Assuring this involves in depth analysis, correct selection of container closure system and proper execution.

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● Everchanging and stringent statutory requirements in countries to which we export, besides, competitive pricing and growing number of players in regulated and emerging markets. We should focus on overall life cycle of product and package including logistics to meet the requirements and deliver cost effective, quality packaging.

In the long term ● We need to shift focus to patient compliance and make user-friendly packaging for information and usage, dosage alerts and accurate dose delivery systems. The packaging should compliment the product, for instance, intelligent container-closure assembly for products of novel drug delivery system. ● We need to reduce repeated market complaints, often occurring during packing operations. Improved and automated packing machinery with identifying and rejection mechanisms of defects and deficiencies in packages will need to be adopted.

MESSAGE TO THE INDUSTRY The pharma industry is a lifeline industry. India, as ‘Pharmacy of the world’, will continue its journey in spite of challenges. The growth rate has come down in FY 2017 when compared to last five years due to factors such as market situation in the US which is the largest overseas market contributing to about 50 per cent of annual turnover to leading industries, more generic players from India and other countries, increased competition leading to price erosion and saturation in patent expiry. However, top leaders of Indian industry are already gearing up to overcome the challenges by increasing their R&D budgets, speciality drugs, niche molecules and complex therapeutic drugs in their pipeline, increasing their brand in Europe and the Emerging Markets. If strengthened by government initiatives and incentives, it will again touch double digit growth rate.

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✪ EDUCATION: MASTERS IN PACKAGING/DMS AND DIPLOMA IN MATERIALS MANAGEMENT ✪ CURRENT ORGANISATION: SUN PHARMACEUTICAL INDUSTRIES ✪ DESIGNATION: AVP ✪ EXPERIENCE IN PHARMA INDUSTRY: APPROX 27 YEARS (WORKED IN ORGANISATIONS LIKE RALLIS, DABUR, RANBAXY & SUN PHARMA) ✪ AWARDS & RECOGNITIONS: MORE THAN 50 AWARDS ON GLOBAL PLATFORM IN VARIOUS CATEGORIES OF PACKAGING AND MACHINERY ✪ PATENTS FILED, IFANY: DUAL PURPOSE MEASURING DEVICE, EASYTEAR BLISTER,TWIN CHAMBER FOR DRY POWDERS

RAHUL BHARGAVA

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CONTRIBUTION TO INNOVATION IN PACKAGING The areas worked upon include ● Flip off seals ● Plastic bottles for dry powders ● Pressure sensitive labels – hanger and perforated ● Machine parts for cold form laminate/aclar structures ● Multilayer bottle for product stabilisation ● CR blister and wallet machine ● Inks, varnishes and lacquer coating ● Dual chamber for dry powders etc. Worked towards overall improvement in convenience, towards novelty and quality packaging at optimised cost. Ease in use of product for end user, marked improvement in quality of packaging, productivity enhancement and bringing new technologies into country at optimised cost are key benefits derived due to above developments.

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INDIA IS HUB OF GENERIC INDUSTRY, HENCE THERE IS EXPECTATION FROM PACKAGING TO PLAYA KEY ROLE IN DIFFERENTIATION IN MARKET PLACE FOR BRAND BUILDING

DEMANDS/TRENDS IN PHARMA PACKAGING India is hub of generic industry, hence there is expectation from packaging to play a key role in differentiation in market place for brand building. This differentiation could be overt (visible to patient) or covert (not openly visible). The three most demanding aspects of pharma packaging are: a) Convenience: Providing convenience to patient for easy use of medicine b) Safety: Safe material for packaging, child resistant but at the same time easy for senior citizens c) Dose adherence: Patients tend to forget and discontinue full therapy, hence a simple mechanism for reminder and compliance packaging can help improve dose adherence. CHALLENGES IN PHARMA PACKAGING With challenging regulatory scenario, the pharma packaging industry need to

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concentrate on upgrading their existing systems to eliminate errors, effective process controls, smooth shop floor operations and maintain consistent quality at competitive cost. We have to focus on being innovative for ease of use by end customer, use of anticounterfeiting measures to avoid entry of spurious drugs into market, new materials for improved barrier, new machineries for enhanced productivity and have vendor base that partners to keep improving conversion technologies, optimising specification parameters, reduce wastages and help produce quality packaging materials with high degree of performance. DRIVERS OF GROWTH In this growth, the key drivers will be areas such as new drug delivery systems and ways to administer drugs using innovative packaging designs and high end material and machine sciences with clear focus on patient

convenience. Another driver could be serialisation and implementation of significant portion of Track & Trace by Indian pharma industry, ahead of many across globe, which can give BIG push to exports. MESSAGE TO THE INDUSTRY For long packaging has been the silent salesman but the industry has now realised that packaging can also be interactive with use of smart packaging. This smart packaging could be through use of novel technologies or devices or use of advance techniques enforcing novelty in pharmaceutical packaging. With market turning into self-service mode, the role of packaging is increasingly becoming significant covering areas such as convenience, aesthetics, quality and affordability for consumers to choose and make a decision at point of purchase.

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✪ EDUCATION: BACHELOR OF SCIENCE FROM GUJARAT UNIVERSITY ✪ CURRENT ORGANISATION: SERUM INSTITUTE OF INDIA, PUNE ✪ DESIGNATION: ADDITIONAL DIRECTOR (HEAD- PACKING, PACKAGING DEVELOPMENT & CONSIGNMENT DISPATCH) ✪ EXPERIENCE IN PHARMA INDUSTRY: 29 YEARS (CORE PARENTRAL, JECHINES PHARMACEUTICALS,TORRENT PHARMACEUTICALS, INTAS PHARMACEUTICALS, SERUM INSTITUTE OF INDIA ✪ AWARDS & RECOGNITIONS RECENTLYAWARDED FOR IMPROVEMENT IN PRODUCTIVITYAND OEE IMPROVEMENT IN PACKING DEPARTMENT BY CHALLENGING CONVENTIONAL PRACTICES AND IMPLEMENTATION OFAUTOMATION

RAJENDRAKUMAR N SUTHAR

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CONTRIBUTION TO INNOVATION IN PACKAGING ● Customised solution developed for automatic packaging of combination product such as vaccine along with its diluents and needle with blister pack and same will be packed on automatic packaging machine ● Cold chain validation is very challenging task in the vaccine industry hence innovatively developed and harmonised the packing material which will take care all the SKU and improved delivery times ● Contributed to develop the special packing machine for R&D lab model

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SPEEDY INTRODUCTION OF GENERIC DRUGS INTO THE MARKET HAS REMAINED IN FOCUS AND IS EXPECTED TO BENEFITTHE CONSUMER AS WELL AS PHARMA COMPANIES

MOST DEMANDING ASPECTS OF PHARMA PACKAGING In the short term ● Affordable cost ● Automation ● Regulatory requirement harmonisation In the long term ● On-time product delivery ● Education and training ● Packaging material consistency in supply

and quality

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OUTLOOK FOR THE PHARMA INDUSTRY The Indian pharma market size is expected to grow to $100 billion by 2025, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others. Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-

cancers that are on the rise. The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the consumer as well as pharma companies. In addition, the thrust on rural health programmes, lifesaving drugs and preventive vaccines also augurs well for the pharma companies.

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✪ EDUCATION: GRADUATE IN CHEMISTRY FROM BERHAMPUR UNIVERSITY & POST GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP, MUMBAI ✪ CURRENT ORGANISATION: ABBOTT HEALTHCARE ✪ DESIGNATION: ASSOCIATE DIRECTOR – PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: MORE THAN 20 YEARS ✪ AWARDS & RECOGNITIONS: RECEIVED MANY INTERNATIONALAND INDIAN PACKAGING AWARDS ✪ PATENTS FILED, IFANY: ● MORE THAN 10 GLOBAL PATENTS ● WO2010109488 (A4) ENTITLED “A DEVICE FOR TRANSFERRING LIQUIDS FROM A CONTAINER TO AVAPORIZER” ● EP2526323 ENTITLED “A DEVICE FOR TRANSFERRING LIQUIDS FROM A CONTAINER TO AVAPORIZER” ● WO/2011/070591 (A3) ENTITLED “A DEVICE FOR SPILLAGE FREE TRANSFERRING VOLATILE LIQUIDS FROM A BOTTLE TO THE RESERVOIR OFAVAPORIZER”

CONTRIBUTION TO INNOVATION IN PACKAGING More than 20 years of packaging development experience in domestic and international markets with an outstanding track record of driving and implementing innovation, differentiation, cost optimisation, sustainability, new products/life cycle management (LCM) packaging projects

RAJESH KUMAR MISHRA

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PACKAGING IN THE PHARMA INDUSTRY HAS UNDERGONE MAJOR CHANGES IN THE PAST DECADE.THIS IS MAINLY DUE TO THE ADVENT OF NEW PACKAGING MATERIALS AND TECHNOLOGIES

TRENDS IN PACKAGING The pharma industry has previously not seen much packaging innovation initiatives, held back by an apparent general apathy for packaging, seeing it as having a more functional role and consequently focusing on product development in their pursuit of competitive advantage. This is now changing. The combination of an increase in branded generic/OTC products and an increasingly competitive marketplace has led to far more appetite to see packaging innovation as an important differentiating tool which can make a meaningful difference in a patientâ&#x20AC;&#x2122;s life. Packaging in the pharma industry has undergone major changes in the past decade. This is mainly due to the advent of new packaging materials and technologies. This has not only supported the pharma formulations on quality, safety and compatibility but also improved product security (tamper evident, child resistant, anti-

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counterfeiting etc) and adherence to medication. Further, with new levels of transparency, consumers now have an access to more information than ever and packaging serve as an important medium of communication between to product and the patient. CHALLENGES IN PHARMA PACKAGING Pharma packaging has to balance lots of complex considerations. Leaving behind relatively simple issues such as developing good designs and communicating with customers, pharma packagers are concerned to more pressing concerns which include fighting with counterfeiting, encouraging patient compliance, ensuring drug integrity and balancing child-resistance and accessibility for the elderly. Issue of environment safety is also key concern for both developed and developing countries packaging industry.

DRIVERS OF GROWTH Packaging innovation can be a chicken-or- theegg situation. Is the innovation being driven by consumer trends, or is new and inventive packaging driving trends among consumer packaged goods? It would probably be the both and they have become major drivers for pharma packaging. MESSAGE TO THE INDUSTRY Being packaging is the touch base for customer and is the second moment of truth (SMOT) in a way as to engage the consumer during and after the purchase of products, Therefore, the patient centric packaging is the key to make the medication enjoyable experience rather than the old cumbersome process. Further, pharma products should be designed in such a way that it gives a soothing impact to the users; also the medicine itself has healing effect, so its packaging should complement its features as well.

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✪ EDUCATION: GRADUATE IN CHEMISTRY FROM MUMBAI UNIVERSITY POST GRADUATE IN PACKAGING ENGINEERING FROM IIP, MUMBAIMBA IN OPERATIONS FROM ICFAI,TRIPURA UNIVERSITY ✪ CURRENT ORGANISATION: UNOSOURCE PHARMA LTD. (AN AKUMS ENTERPRISE), R&D CENTRE, MAHAPE, NAVI MUMBAI ✪ DESIGNATION: HEAD - PACKAGING DEVELOPMENTAND LABELLING (ANDA) ✪ EXPERIENCE IN PHARMA INDUSTRY: 11 YEARS (WORKED WITH WATSON PHARMA (NOWAS TEVA), INDOCO REMEDIES,TORRENT RESREACH CENTRE,ALKEM LABORATORIES AND UNOCOURCE PHARMA ) ✪ AWARDS & RECOGNITIONS WELL FELICIATED AS BEST PERFORMER FOR ANDA PACKAGING DEVELOPMENT IN VARIOUS COMPANIES WELL RECOGNISED IN THE INDUSTRYAS A DYNAMIC PACKAGING PROFESSIONAL

RAJSHRI CHETAN PARDESHI

72 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Development of three pieces LDPE 3ml plastic vial for eye drop ANDA ophthalmic project helped to propose small pack sizes like 2ml and 3ml fill volume. Also, it increased total pallet loadability due to customised size resulting more supply of unit pack per fright. ● Customised HDPE plastic bottles for solid oral ANDA projects helped to improve aesthetic look of overall pack resulting good market gain. ● Designing smaller size desiccant pouch for smaller containers helped to extend the self-life of products and to improve machinability for better output. ● Developed Contraceptive blister calendar packs for single, two colors and four-color tablets where assorted color of tablets made possible to end user to choose right dosage on right day.

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TECHNICALAND COMPETENT PEOPLE NEED TO BE WELCOME BY PHARMA COMPANIES TO CONCLUDE RIGHT DEVELOPMENTALONG WITH USE OF RIGHT INFORMATION AND RESOURCES

TRENDS IN PACKAGING Trends in packaging is considerably being adopted by industries as lot of inventions are happening with respective to quality, safety, delivery and convenience of handling. Pharma packaging has to balance lots of complex considerations. Pharma industry, research and manufacturing technologies are continuously evolving with demands of environmental ethics, patient compliance and novel medicaments. This had driven significant developments in packaging and delivery systems. To maintain integrity of pharma products during storage, shipment, and delivery, quality of packaging provides assurance for all these. Software and automation technology services are designed to improve speed-to-market while increasing the accuracy of design and testing, thus bringing significant cost savings to the customer and the pharma industry.

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CHALLENGES IN PHARMA PACKAGING In the short term ● Ensuring R&D packaging development at the stage of development of molecule so that right packaging can be designed to extend the product shelf life and quality. ● Timely awareness of regulatory norms and guidelines to deliver a quality product. ● Right study of packaging market requirements to continue and enhance business consistency. ● Designing quality product with cost effective materials to compete in the market. In the long term ● Training at each level of packaging to deliver right output. ● Changeover of manual to automatic packaging operation. ● Designing regulatory documents as per current norms and regulations. ● Right training of SAP system at each level of business operations.

DRIVERS OF GROWTH Current regulatory norms, regulations awareness and automation will be major drivers in the pharma industry as the USFDA is keen to ensure adherence with the norms and regulations for packaging to ensure that the right product with right package, along with excellent quality and shelf-life reaches the end user. Similarly, automation also helps to avert manual intervention, resulting in no market complaints with high output and minimal call backs of consignments. MESSAGE TO THE INDUSTRY Packaging plays a vital role in the pharma industry. It is directly connected to the product and ultimately, with the company’s business. Hence, it is very necessary to know the importance of packaging at the initial stage of molecule development so that further issues, if any, can be addressed in time to avert problems later. A right beginning always leads to right and excellent output.

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✪ EDUCATION: POST GRADUATION IN PACKAGING TECHNOLOGY ✪ CURRENT ORGANISATION: MERCK ✪ DESIGNATION: PACKAGING LEAD- PRODUCTAND PROCESS INNOVATION ✪ EXPERIENCE IN PHARMA INDUSTRY: OVER 10 YEARS (WORKED WITH MERCK,ZOETIS INDIA, RANBAXY LABORATORIES) ✪ PATENTS FILED, IFANY: DEVELOPED CONSUMER FRIENDLY DUAL-PURPOSE MEASURING DEVICE WHICH HAS BEEN FILED FOR PATENT RIGHTS ✪ ARTICLES/PAPERS PUBLISHED: AN ARTICLE ON CAPS AND SPECIALITY CLOSURES (AS A PART OFACADEMIC CURRICULUM) ✪ AWARDS & RECOGNITIONS : SELECTED AS PSTL FOR IMPARTING TRAINING TO ALLZOETIS SITES IN ZOETIS GLOBAL SUPPLYW.R.T PACKAGING INITIATIVES/NEWTRENDS IN PACKAGING

REETIKA PRASHAR

74 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Developed consumer friendly dual-purpose measuring device which has been filed for patent rights ● Developed patient complaint child resistant carded blister pack which won the INDIASTAR award for the best packaging in the pharma sector. ● Developed family of bottles for oral liquids with ring mark and view strip for accurate dosing and consumer convenience ● Developed LDPE plastic vial for liquid injectable formulation for US market and got it DMF filed and approved. ● Implemented fix-o-form labels for bottle packs

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GROWTH IN BIOLOGICAL SCIENCES AND INCREASING POWER OF CONSUMER IN HEALTHCARE BUSINESS WOULD BE THE POTENTIAL PRIMARY DRIVERS

THE ADVANTAGES OF THESE ENDEAVOURS WERE Cost optimisation using the tools: Techno commercial initiative ● Light weighting of glass bottles ● ROPP caps caliper optimisation ● Light weighting of oral liquid bottle Value engineering ● Changeover from plastic drum to square fibre drum ● Optimisation of blister pack design for tablets leading to higher productivity and savings in packaging material consumption. Innovation ● Introduction of new holograph with 12 inbuilt security features and customised the machine to transfer the same on the blister packs ● Developed a dispenser pack for Bolus in form of a wallet pack with focus on aesthetics, consumer convenience and cost effectiveness

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DEMANDING ASPECTS IN PHARMA PACKAGING The four aspects that are most demanding and equally important include: ◗ Human aspects: Safety, compliance/patient adherence, consumer friendliness ◗ Environmental aspects: Use of environmentally-friendly materials, reduced use of resources, fill-rate ◗ Economic aspects: Packaging costs, marketing, machinability ◗ Product/manufacturing aspects: Product protection, flow information, product information: labelling, PIL’s etc. Another important aspect is green logistics, the process of minimising damage to the environment due to the logistics operations of an organisation.

OUTLOOK FOR THE PHARMA INDUSTRY The growth path for Indian pharma industry is likely to be moderate on the account of decelerating growth from the US, increased competition leading to price attrition, generic drug acceptance reaching saturation levels. For the period between FY 2018 to FY 2020, the industry is projected to grow at the rate of about 7-10 per cent. In the next coming years, the pharma industry will begin to experience major changes as companies are investing huge amounts in strengthening their R&D. Growth in biological sciences and the increasing power of the consumer in the healthcare business would be the potential primary drivers of these changes. Advances in science along with increased consumer demand for pharma and passage of regulation allowing companies to market products directly to consumers, already have begun to transform the landscape for pharmaceuticals.

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✪ EDUCATION: BACHELOR OF SCIENCE (CHEMISTRY) FROM CALCUTTA UNIVERSITY; POST GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP, MUMBAI AND DIPLOMA IN MARKETING MANAGEMENT ✪ CURRENT ORGANISATION: SUN PHARMA ✪ DESIGNATION: SENIOR GENERAL MANAGER, PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 24 YEARS ✪ PATENTS FILED, IFANY: 5 PATENTS

SANTANU CHOWDHURY

76 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING Have consistently derived consumer-centric innovations in pharma packaging. For e.g. 360o valves for aerosols for enhanced consumer experience, profiled sachets for analgesic drug category, airless packs controlled and measured dispensing, implementation of in mold labelling technology for measuring cups in India, carded blisters for patient compliance. Changing to such patient-centric packaging has been a gradual, almost linear evolution, which helped achieve a living of connected existence with the consumer. Have always ensured minimal impact to environment following a sustainable packaging development approach. He has been one of the propagators of the OTC packaging concept in the Indian pharma fraternity.

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THE MAJOR DRIVER OF GROWTH IN THE PACKAGING INDUSTRY IS ADVANCED PACKAGING TECHNOLOGYWHICH ENSURES SAFETY, QUALITY AND LONG SHELF LIFE OFTHE PRODUCTS

TRENDS IN PACKAGING ‘Need is mother of all inventions’, a phrase best at describing the emerging technologies in pharma packaging. Not only healthcare systems, but patients too, are seeking improved quality in care. Today’s patients are also consumers who are used to just-in-time, user-centered product innovations that make life easier and more convenient. The change in mindset is deriving new innovations and developments through packaging. Packaging aims not just at providing a healthy solution but also a simple and friendly solution to connect, which could further be aided through digital packaging platforms, incorporating augmented reality. CHALLENGES IN PHARMA PACKAGING The key challenge is to improve patient compliance through effective tools while

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reducing costs. Adherence i.e. right medication dose and to the right person and at the right price are one of the major demands in pharma packaging. Moreover, each packaging should clearly communicate the benefits of the medication to the consumer. Apart from patient compliance, anticounterfeiting and a specialised supply chain are some of the other aspects that need to be looked at in pharma packaging. DRIVERS OF GROWTH The real driver of innovation is the ultimate end-market consumer, which means that packaging producers need well-developed and collaborative relationships with their customers, who are closer to the end consumer. The major driver of growth in the packaging industry is advanced packaging technology which ensures safety,

quality and long shelf life of the products. For instance, in the pharma segment, nanoenabled packaging for blisters is widely used. The pharma packaging market is constantly advancing. As with most other packaged goods, pharma products need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. MESSAGE TO THE INDUSTRY Indian pharma packaging is going to assume a greater importance in the times to come, as we are one of the world’s biggest and growing pharma industries consisting of huge packing/packaging needs. Therefore, packaging design need to focus primarily on the patient adherence mechanism and promote safety, compliance, and ease of use.

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✪ EDUCATION: BACHELOR OF PHARMACEUTICALS TECHNOLOGY, MASTERS DIPLOMA IN PACKAGING TECHNOLOGY, MASTERS DIPLOMA IN MATERIALS MANAGEMENT, CERTIFIED PROFESSIONAL IN SUPPLY MANAGEMENT FROM ISM, US. ✪ CURRENT ORGANISATION: HOSPIRA HEALTHCARE INDIA (A PFIZER COMPANY) ✪ DESIGNATION: GENERAL MANAGER, PROCUREMENT, DIRECT MATERIALS, VIZAG PLANT, PFIZER ✪ EXPERIENCE IN PHARMA INDUSTRY: 29 YEARS (WORKED IN PHARMA COMPANIES LIKE ROCHE PRODUCTS, INFAR INDIA, ORCHID CHEMICALS, DR REDDY’S LABORATORIES,ALEMBIC LIMITED, HOSPIRA HEALTHCARE INDIA ✪ AWARDS & RECOGNITIONS BEST CONTRIBUTOR AWARD – INFAR INDIA VALUED CONTRIBUTOR – DR REDDY’S LABORATORIES MISSION AWARDS – HOSPIRA HEALTHCARE

SHANTANU SHOME

78 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Introduced glassine paper based blister foil for SMX- TMP formulation (trade name – Bactrim DS) 1st time in Indian market with both side registration printing way back in 1992 for Roche Products. ● Formulation division products launching of Orchid Healthcare, development to distribution ● Part of new product launch team, worked in PACE project (productivity & cost efficiency improvement project) as group leader of commercial material procurement team in Dr Reddy’s Laboratories All these efforts were focussed towards cost reduction, productivity improvement, and launching of a new business division

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QUALITY, SERVICE, INNOVATIVE PROCESSES, EFFICIENT SUPPLY CHAIN WITH IMPROVED SYSTEM SUPPORT IS WHAT IS REQUIRED FOR PACKAGING INDUSTRYTO DO WELL IN FUTURE

TRENDS IN PACKAGING Printing technology particularly micro size printing capability is the new trend which has come up as requirement due to serialisation. Also, smaller size label with suitable label application systems is also the trend. As biotechnology based drugs are the future dosage forms, which are mostly injectables, newer types of glass containers are another trend which is catching up. Glass manufacturers are tying up with big pharma companies to develop glass which does not delaminate, difficult to break (almost unbreakable) and also glass cartridges which needs to be silicon-free with easy to slide plungers as many formulations are aggressive to glass. CHALLENGES IN PHARMA PACKAGING Complying with regulatory requirements is always challenging for pharmaceutical

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packaging. Serialisation to track at SKU level with responsibility till final administration of the medicine is the new requirements. How to serialise at dosage level is what the industry is looking at. Controlling cost of medicines, making quality medicine available to every patient is another big challenge for pharma packaging as whenever any new product is launched, optimising the cost of packaging, at material level and also at packaging system level has to be taken care of. Developing innovative packaging solutions for new medicines, evolving personalised care systems, and introducing new products faster to market are the other challenges. DRIVERS OF GROWTH Eco friendly, recyclable packaging materials are going to be the major drivers in pharma packaging space. Due to stricter regulations

and low cost medicine demand, pharma packaging industry is not going to see any new materials coming in, but there is development work going on to improve existing materials performance to meet up advanced quality inspection system needs, compatibility to high speed packaging machinery requirements. In future pharma manufacturers will use more glass, various closure systems, more labels, more paper boards and more of speciality adhesives in packaging processes. MESSAGE TO THE INDUSTRY Quality, service, innovative processes, efficient supply chain with improved system support is what is required for packaging industry to do well in future and to meet pharma industry demands. Technology enabled vision systems for better inspection of produced materials, with no defect supply, should be the future goal.

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✪ EDUCATION: BACHELOR IN CHEMISTRY, POSTGRADUATE DIPLOMAIN PACKAGINGTECHNOLOGYFROM IIP, MUMBAI ✪ CURRENT ORGANISATION: BIOCON ✪ DESIGNATION: ASSOCIATE DIRECTOR, PACKAGING DEVELOPMENT– QUALITY ✪ EXPERIENCE IN PHARMA INDUSTRY: 15 YEARS ✪ AWARDS & RECOGNITIONS ● SEVEN ‘INDIA STAR’AWARDS FOR BIOCON FOR EXCELLENCE IN PACKAGING IN THE PHARMA SEGMENT ● BIOCON AWARD FOR DEVELOPMENTAND LAUNCH OF INNOVATIVE BLISTER TRAY PACK DESIGN ● THREE 'INDIA STAR' – PACKAGING EXCELLENCE AWARDS FOR HIMALAYA DRUG COMPANY FOR THE YEAR 2004 FROM IIP

TJ SARAVANAN

80 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Packaging plays a major role in adherence to drug compliance. Well thought packaging design enables patient adherence and ensure better treatment &amp; outcome. Developed packs having features for ease of use, better communication and effective administration. ● Developed an online process for artwork review through a software application, which is made available on cloud for easy access from any location. This has led the artwork review process to run faster, efficient and with minimized chances of errors. ● Development of Track and Trace program, a project using unique serialised Barcodes with an authentication process, is a significant Contribution to comply with regulations for export products from India.

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PACKAGING IS A PARTAND PARCEL OFTHE PRODUCT ITSELF, BE ITA FOOD, PHARMA OR PERSONAL CARE PRODUCTS. IT IS IMPERATIVE THAT SCIENTIFIC PROCESSES ARE APPLIED TO PACKAGING DESIGN AND MATERIALS

TRENDS IN PACKAGING ● Patience compliance ● Anti-counterfeiting ● Tract and Trace/Serialisation ● Product Authentication ● Sustainable packaging ● Packaging as a part of drug delivery systems CHALLENGES Developing and implementing packaging suitable for running on high speed machines is a key indicator for direction towards improvement and efficiency. These developments throw up different challenges and make demands which are not

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conventional to manual packaging processes. Overcoming these challenges by developing solutions using innovative techniques is the way to achieve desired results. OUTLOOK FOR THE PHARMA INDUSTRY Packaging has always been a part and parcel of the product itself, be it food, pharma or personal care product. Therefore, it is imperative that all the scientific processes being applied for the development of a product are also applied for the packaging designs and materials. With this approach, new challenges will be thrown at the packaging industry. This, in turn, is likely to lead towards higher investments in packaging R&D,

which is low currently. It is essential for the packaging industry to gear up for innovative solutions that the pharma industry is demanding currently and in future. By adopting this approach, pharma packaging sector will come up solutions for product integrity, brand security, patience compliance, and most importantly, affordability. MESSAGE TO THE INDUSTRY There are many benefits of commercial implementation of packaging innovations. These include higher customer satisfaction, patient compliance, better efficiencies in factory outputs and cost effectiveness.

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✪ EDUCATION: HONOURS GRADUATE IN PHYSICS FROM CALCUTTA UNIVERSITY P.G. DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP, MUMBAI ✪ CURRENT ORGANISATION: FRESENIUS KABI ONCOLOGY ✪ DESIGNATION: HEAD - PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 25 YEARS (WORKED IN ORGANISATIONS LIKE JK DRUGS AND PHARMA,WIN MEDICARE, NICHOLAS PIRAMAL,ALEMBIC PHARMA ETC.) ✪ AWARDS & RECOGNITIONS: WELL RECOGNISED AS A PACKAGING PROFESSIONAL IN THE INDUSTRY

SHIVAJI CHAKRABORTY

82 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Designed packaging to reduce the packaging waste ● Designed packaging, using the existing infrastructure, for improved productivity and optimise packaging manpower and cost without impacting the quality and compliance ● Redesign the packaging line to optimise productivity and improved quality ● Contributed developing the architecture of track & trace/serialisation system for supply chain security and traceability as well as regulatory compliance

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PACKAGING IS A MEDIUM THROUGH WHICH THE CUSTOMER/PATIENT CONNECTS WITH THE PRODUCTAS WELLAS WITH THE BRAND OWNER

TRENDS IN PACKAGING Track & trace: One obvious theme is that track & trace continues to be a driving force for change in the pharmaceutical packaging segment for supply chain security Increased focus on personalised care: There’s a greater focus on personalised medicine — one-size-fits-all no longer cuts it. This means smaller batches and shorter lead times for manufacturers up and down the supply chain.

New Biologics Driving Packaging Changes: The rising popularity of new biological drug formulations continues to fuel some unanticipated packaging challenges. These new drugs are quite different from traditional small-molecule formulations, and in some cases, there have been some drug interactions with packaging materials. As a result, there are demand for new formats and materials. CHALLENGES IN PHARMA PACKAGING ● Product stability and quality compliance

Smart packaging for product identification and patient information: 1. RFID tags - In addition to 2D matrix, RFID tags are increasingly used for tracking and tracing the products throughout the supply chain 2. NFC tags - Small, programmable NFC tags embedded in labels to communicate key information to consumers. Just by tapping their NFC-enabled smartphones to the label, patients can access dosage and usage information.

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● Presentation and information ● Identification

● Supply chain security through track &

trace/serialisation solution ● Design a tamper evident packaging for

brand protection ● Maximum automation at packaging levels ● Packaging waste management

DRIVERS OF GROWTH ● Digitisation and customer focus will be

major drivers for growth starting from development to end customer. ● The need for speed-to-market and agility to capitalise on short windows of exclusivity. Also adaptability in the dynamic business scenario

● Convenience ● Regulatory compliance ● Cost optimization ● Development of skilled manpower ● Reduce risk, time and cost ● Reduce risk to the patients by designing

child resistance, elderly friendly packaging ● The need for speed-to-market and agility to

capitalise on short windows of exclusivity ● Optimise the packaging cost

MESSAGE TO THE INDUSTRY Packaging is a medium through which the customer/patient connects with the product as well as with the brand owner. So it is important to understand the targeted market segment/regulatory requirement while designing the pack. Packaging should be designed in such a manner so as to minimise the packaging waste.

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✪ EDUCATION: B.SC. (CHEMISTRY), POST GRADUATE IN PACKAGING TECHNOLOGY FROM IIP ✪ CURRENT ORGANISATION: MANKIND RESEARCH CENTRE ✪ DESIGNATION: HEAD PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: OVER 16 YEARS (WORKED WITH VARIOUS PHARMA COMPANIES LIKE PAHARPUR INDUSTRIES,AUROBINDO PHARMA,JUBILANT GENERIC,ZYDUS CADILA, DR REDDY’S LAB ✪ AWARDS & RECOGNITIONS : SPEAKER AT PHARMASAFE INDIA, AUTHENTICATION FORUM ACTIVE ALUMNI OF INDIAN INSTITUTE OF PACKAGING

SOUMYANATH MISHRA

84 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Developed suitable packaging system for highly moisture sensitive products for solid oral doses. ● Developed alternative structure for pharma lidding foil for solid oral doses packaging. ● Innovative packaging development on Lamitube which is replaced to conventional aluminum metal tube for highly volatile pharmaceutical products. ● Innovative packaging development on glass vials for highly sensitive injectable products where pH shifting was the major issue. ● Introduce the concept of harmonisation, optimisation and rationalisation of packaging to get the benefit at commercial mass production at plant level.

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TECHNOLOGICALADVANCEMENTS IN PHARMA PACKAGING SOLUTIONS OFFER IMMENSE INNOVATIVE AND ADVANCED APPLICATIONS TO IMPROVE THEIR PACKAGING STANDARDS

TRENDS IN PHARMA PACKAGING According to the World Health Organisation (WHO), 35 per cent of the fake drugs sold all over the world comes from India and it occupies the counterfeit drug market of nearly `4,000 crores. 20 per cent of the drugs sold in India are fake. A patient receiving an authentic drug for his disease has become a challenge these days. So, packaging has a very critical role to play in prevention of anticounterfeiting drug. Track and trace systems and serialisation are being given importance and getting widely adopted among all anticounterfeit technologies in different countries. Some popular trends include: 1. In-mould labelling (IML) technology: It uses one of the most cost effective technologies for pharma packaging. 2. Patient-centric packaging: It comprises child resistant packaging, senior-friendly etc. The packaging should help reduce

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medication error and help patient compliance. DEMANDS/CHALLENGES Changes in pharma industry research and manufacturing technologies are driving significant developments in packaging and delivery systems. An increase in the number of large-molecule, biopharma drugs in development pipelines has led to an increase in the need for injectable packaging and administration systems. The old glass and elastomer closure systems may not provide effective barrier properties needed for highvalue, lifesaving therapies. Packaging and delivery systems will be more demanding aspects for drug products. For example; a pharma company needs a prefillable system that protects the integrity of the packaged drug product over time and will function as represented over the full shelf life of the drug product.

OUTLOOK FOR PHARMA INDUSTRY Pharma packaging market is expected to reach in high value. The market is expected to witness notable growth in the coming years, owing to the increased R&D, new innovations in packaging materials, growth in generic market, and rise in trend of contract packaging. Growth in demand for reusable and eco-friendly packaging is expected to drive the market. Drug manufacturing companies have started to adopt eco-friendly packages to overcome environmental concerns. Technological advancements in pharma packaging solutions offer immense innovative and advanced applications to improve their packaging standards. The impact of these drivers is expected to increase significantly due to increase in awareness about various diseases, rise in selfmedication, and growth in usage of OTC drugs.

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✪ EDUCATION: POST GRADUATE IN PACKAGING TECHNOLOGY FROM IIP, MUMBAI, MBA ✪ CURRENT ORGANISATION: MYLAN LABORATORIES ✪ DESIGNATION: ASSOCIATE VICE PRESIDENT - GLOBAL PACKAGING STRATEGY (OSD) ✪ EXPERIENCE IN PHARMA INDUSTRY: 21 YEARS OF EXPERIENCE PACKAGING DEVELOPMENT/STRATEGYWITH 17 YEARS IN PHARMAAND FOUR YEARS IN FMCG SECTOR. HAVE WORKED WITH HINDUSTAN LEVER, RANBAXY LABORATORIES AND MYLAN LABORATORIES ✪ AWARDS & RECOGNITIONS: PACKAGING & DEVELOPMENT PROFESSIONAL OF HIGH REPUTE IN THE PHARMA INDUSTRY ✪ PATENTS FILED, IFANY: DEVELOPMENTAND IMPLEMENTATION OF DESICCANT INTEGRATED CLOSURE FOR ANTIRETROVIRAL PRODUCT. THIS CONTAINER/CLOSURE PACK HAS BEEN PATENTED.

SOURAV MITRA

86 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Developed new blisters with oxygen scavengers ‘in-built’ in the blisters. ● Developed new packaging to meet global market requirements and at the same time complying with quality and regulatory aspects. ● Led many packaging driven cost improvements initiatives to meet the pricing challenges. All these enabled in providing more patient compliant and cost-effective packaging to patients.

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THE CHANGING LANDSCAPE OF REGULATORY REQUIREMENT, PATIENT FRIENDLY PACKS, ECO-FRIENDLY PACKS, HAS TRANSFORMED THE PACKAGING INDUSTRY

TRENDS IN PACKAGING The outlook of the packaging industry, with specific reference to pharma sector, has drastically undergone a major change since the last decade. Earlier, it was more confined to merely providing a pack catering to basic minimum requirements of the product. However, the changing landscape of regulatory requirement, patient friendly packs, eco-friendly packs, thinking ahead of competition has transformed the packaging industry. It has evolved into one of the important functions, contributing towards patient need and stability of the products. The changing scenario helps in exploring innovative, yet cost effective packaging solutions and implementing new strategies to overcome them without compromising on the integrity of the product. The thoughtful development of pack(s) has led to contributing towards savings in logistics costs in terms of freight.

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OUTLOOK FOR THE PHARMA INDUSTRY ● Do more with less, as generic business is

cost sensitive ● Cost effective anti-counterfeit packaging ● Environmental friendly sustainable packaging CHALLENGES IN PHARMA PACKAGING Short term ● Compliant and cost-effective packaging ● Operational friendly packaging ● Simplified and harmonised packaging Long term ● Risk assessment and mitigation strategy in packaging. ● Sustainable packaging with respect to increasing packaging cost and market competition. ● Affordable and user-friendly technology and regulations in packaging (e.g.: Track & Trace, epedigree, …etc)

MESSAGE TO THE INDUSTRY ● Adhere to regulatory requirements ● Design must be compatible with product, patient and regulation ● Understand all aspects of packaging with specific reference to the nature product and addressing the needs of the market/patient ● Improvise on the existing packs to gain more on cost effectiveness, patient convenience resulting in enhanced compliance and improvements of product shelf-life, an indicator of quality, thereby getting an edge over the competition ● Keeping abreast of latest developments and trends in packaging and development. Implement them to increase product/brand value ● Maximise the power of technology to deliver patient-friendly products without compromising on the quality of product and controlling the cost.

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✪ EDUCATION: BE MECHANICAL, PG PACKAGING, CPP, DIPI (PLASTICS), MASTERS IN FINANCE MANAGEMENT ✪ CURRENT ORGANISATION: GLAXOSMITHKLINE CONSUMER HEALTHCARE ✪ DESIGNATION: HEAD OF PACKAGING – RESPIRATORY CATEGORY ✪ EXPERIENCE IN PHARMA INDUSTRY: 20 YEARS OFWHICH 10 YEARS IN OTC PHARMA IN GLAXOSMITHKLINE CONSUMER HEALTHCARE ✪ AWARDS & RECOGNITIONS: 28 AWARDS OUT OFWHICH SIX IN OTC PHARMA, INCLUDING INDIASTAR,AMERISTAR & WORLDSTAR ✪ PATENTS FILED, IFANY: NON PLANAR CLAMSHELL, ROLL ON DISPENSER FOR PAIN RELIEF ✪ ARTICLES/PAPERS PUBLISHED: NINE PAPERS PUBLISHED OFWHICH TWO WITH A SPECIFIC FOCUS ON PHARMA. 23 PAPERS PRESENTED OFWHICH 10 IN PHARMA PACKAGING

SRIMAN BANERJEE

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CONTRIBUTION TO INNOVATION IN PACKAGING ● Growing business through innovation, Rx to OTC switches, compliance and safety and sustainability. ● OTC products are typically kept behind the shelf, providing dispenser cartons on trade improved visibility and increased sales by 10 per cent. ● Rx to OTC switches for nasal sprays provided consumers with self-medication and created new business opportunity of $ 250 million. ● Global implementation programmeof CRSF provides safety for children. ● Worked on sustainability in packaging to reduce carbon foot print and a step towards environmentally friendly solutions.

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CONNECTED HEALTH IS THE NEWTREND AND PACKAGING IS AN ENABLER THROUGH DIFFERENTAVAILABLE TECHNOLOGIES OF NFC, QR CODE, ETC

TRENDS IN PACKAGING Connected health is the new trend and packaging is an enabler through different available technologies of NFC, QR code, etc.

● Access packs for emerging consumers. ● Safety and compliance ● Moving from packaging to devices

In the long term: ● E-commerce packaging

CHALLENGES IN PHARMA PACKAGING The biggest challenge in pharma industry are changes in the regulatory environment, which means you need to be agile to make changes at a short notice. In addition, the different standards being followed worldwide, be it for serialisation or devices, does not provide economies of scale and increases complexity and cost of goods.

● Packaging enabling connected digital health

MOST DEMANDING ASPECTS OF PHARMA PACKAGING In the short term:

OUTLOOK FOR THE PHARMA INDUSTRY Over the next decade, pharma industry would evolve from the traditional pills to

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● Sustainability

DRIVERS OF GROWTH The key drivers for growth would be penetration of products in emerging market, devices for convenience and usage as well as connected health to drive compliance, all the three in effect will drive consumption thereby growth.

devices and connected health platform, enabling consumers and patients to selfmedicate through in home diagnostics. The connected health platform would drive compliance, provide information and create an ecosystem of data to enable research. MESSAGE TO THE INDUSTRY Packaging is a key part in pharma industry as it provides patients and consumers treatment to live a health life through medicines. As we go ahead we need to move the baseline to: 1. Provide affordable treatment to a wider demography 2. Provide effective treatment through connected health platforms and drive compliance and convenience

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✪ EDUCATION: M.SC. FROM S.M.U., INDIA; PG DIPLOMA IN PLASTICS TESTING AND CONVERSION TECHNOLOGY FROM CIPET B.SC. (B.Z.C.) FROM KAKATIYA UNIVERSITY GRADUATE DIPLOMA IN PACKAGING TECHNOLOGY FROM IIP, MUMBAI ✪ CURRENT ORGANISATION: INTAS PHARMACEUTICALS,AHMEDABAD ✪ DESIGNATION: DGM - PACKAGING DEVELOPMENT ✪ EXPERIENCE IN PHARMA INDUSTRY: 20+ YEARS (WORKED WITH OR GANISATIONS SUCH AS INTAS PHARMACEUTICALS,TORRENT PHARMA RESEARCH CENTRE, CADILA PHARMACEUTICALS,AMERICAN FORMULARY, FENOPLAST ETC) ✪ AWARDS & RECOGNITIONS : WELL RECOGNISED IN THE INDUSTRYAS A PACKAGING PROFESSIONAL

SURESH GANAPURAM

90 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Established different types of packaging polymer formulations for blister packaging of PVC compounding according to pharma products requirements ● Developed unique packaging and labelling for blisters, bottles, tubes etc. ● Enabled complete automation for packaging and labelling operations. Autocartoning and book let feeders’ implementation ● Worked on harmonisation and standardisation projects for pharma export packaging ● Undertook many COG reduction projects by doing pack changes, pack optimisation and down gauging/GSM reduction subjected to formulations stability/ marketing/regulatory requirements

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OUTLOOK FOR PHARMAWILL BE VERY PRECISE AND HIGH ACCURACY REQUIRED IN EACH AND EVERYASPECT FROM R&D STAGE TO COMMERCIALISATION THROUGHOUTTHE GLOBE

TRENDS IN PHARMA PACKAGING Pharma packaging is being driven by factors such as patient safety, ease-of-use, need to improve product shelf life, detect pilferage and counterfeiting before administration, build brand, brand loyalty and enable cost effectiveness. Pack optimisation in the consumption of packaging material used for drug product has also drastically reduced, which in turn, is beneficial for organisations with respect to cost, polymer yield and environment. Novel kind of design/approaches have helped eliminate transportation hazards like leakages, spillages, breakages, physical shocks and cosmetic defect, especially for export markets, and are beneficial with respect to cost of goods and organisation.

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CHALLENGES IN PHARMA PACKAGING The major challenges in this arena are: ● Ensuring precise labelling and packaging of PFS and dual chamber PFS, drug delivery system through medical devices for parenterals/biologics/vaccines etc. considering patient safety, user friendly requirements. ● Regulations on various global serialisation and anti-counterfeiting requirements for pharmaceuticals drug product track and trace technology throughout the global supply chain. And its implications on Packaging, Labelling and Artworks. OUTLOOK FOR PHARMA PACKAGING INDUSTRY The pharma sector in future will be very precise and high accuracy is required in each

and every aspect, from the R&D stage to commercialisation, throughout the globe. It’s also time to develop alternate for pharma packaging lidding material, considering the ‘Aluminium Core’ shortage and availability concerns of pharma grade aluminium foil. With upcoming stringent regulatory requirements like serialisation, track and trace/labelling. Chances for more business tie-ups and mergings will be there to ensure sustainability and to capture the business. Productivity may be impact for the short term due to these regulations. But in the long term, highly productive, value-driven organisations which offer in-line and set-up solutions in serialisation, artificial intelligence, digitisation, TnT and precise labelling automations will do very well.

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✪ EDUCATION: HONOURS GRADUATE IN MICROBIOLOGY, DIPLOMA IN PACKAGING FROM IIP, MSC IN REGULATORYAFFAIRS AND CLINICAL RESEARCH ✪ CURRENT ORGANISATION: FDC ✪ DESIGNATION: SENIOR GENERAL MANAGER ✪ EXPERIENCE IN PHARMA INDUSTRY: 29 YEARS (WORKED WITH LUPIN, INDOCO REMEDIES, RAPTAKOSS BRETT, GLENMARK, FDC ) ✪ AWARDS & RECOGNITIONS: KNOWN NAME IN THE PHARMA INDUSTRYAS A PACKAGING AND REGULATORY PROFESSIONAL ✪ ARTICLES/PAPERS PUBLISHED: COVERED IN PAPER IN PACK MAGAZINE JULY 2017 EDITION

TRIPTI NAKHARE

92 | PHARMA PACKAGING AND LABELLING CONCLAVE

CONTRIBUTION TO INNOVATION IN PACKAGING ● Developed child resistant foil for an Indian vendor as per EU requirements and commercialised the same ● Developed suitable dropper tips for ophthalmic bottles made with BFS technology achieving various drops sizes ● Developed cost effective 2D barcode system(hardware and software) for DGFT ● Developed cost effective hardware for DSCSA/FMD compliance with help of Indian vendors ● Developed various vendors for compliance to current Regulatory and quality requirements ● Brought about various cost effective changes maintaining quality standards ● Introduced various controls to minimize packaging errors be it in packaging development( artwork management with use of software), QC and production packaging. ● Being proactive to the changing regulatory requirements across regions and India.

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STRIKING A BALANCE BETWEEN CONSTANTLY MEETING SAFETY, QUALITYAND REGULATORY REQUIREMENTS AND CONTROLLING COSTS WILL CONTINUE TO BE A CHALLENGE

TRENDS IN PHARMA PACKAGING ● Consumer engagement through packaging ●Packaging supporting tamper evidence, patient compliance/comfort and security needs ● Packaging and delivery systems as a differentiator for drug products will continue to become more important ● The wider use of technologies such as RFID tags embedded in the plastic button affixed to the seal, or ultraviolet inks applied to the seal, providing item-level security. ● With advances in material science, we can expect cleaner elastomeric formulations by utilising BFS technology for manufacturing primary packaging and delivery-system components. ● The pharma packaging trends are on the verge of innovative rapid growth provided the needs of the product, its security, cost and patient convenience is taken into consideration to build brand identity. ● Increased focus on child resistant packaging vs geriatric (senior) friendliness

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CHALLENGES IN PHARMA PACKAGING Navigating for the various country specific track and trace requirements for compliance be it (DGFT/DSCSA/FMD and other country specific requirements ) is a challenge for the entire industry leading to stream lining equipment space and getting modular add ons on the packaging lines. ● Dependency on import for various packaging materials (eg: Indigenous basic aluminium foil manufacturer). ● Continued employment of trained packaging staff. ● In coming days the regulatory focus will include primary packaging material manufacturers and probably SRA countries may expect audits by qualified persons/regulators. ● Improvement in printing technology for faster delivery/accurate prints at reasonable costs ● Automation of packaging lines to reduce human intervention

DRIVERS OF GROWTH ● New biologics are driving packaging changes –

biological products tend to interact with conventional packaging materials hence creating a demand for new packaging materials ● Increased use of self administered therapies ● Growth in demand for reusable and ecofriendly packaging is also expected to drive the market ● Digitisation and packaging that communicates with patients ● Advanced manufacturing processes, including green packaging technologies, using environment-friendly materials to develop pharmaceutical packages, which inflict minimal harm to the environment. MESSAGE TO THE INDUSTRY Pharma packaging is highly regulated and hence for pharma packaging professionals, striking a balance between constantly meeting the safety, quality and regulatory requirements and controlling costs while minimising write offs will continue to be a challenge!

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NOTES

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PPL Leaders Handbook - March, 2018  
PPL Leaders Handbook - March, 2018  
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