Express Pharma (Vol.13, No.17) July 01-15, 2018 by Indian Express

CONTENTS Vol.13 No.17 July 1-15, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

CELEBRATING FR&D LEADERSHIP

BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer

MARKET

MANAGEMENT

PHARMA ALLY

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)

IDEAL CURES LAUNCHES NEW FILM COATING PRODUCTS AT 2ND FDD CONCLAVE

DECOPULSE: EFFICIENT AND GENTLE, WITH GREATER PRODUCTION SAFETY

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South

P36: INTERVIEW

Debnarayan Dutta - East

James Thomas Country Manager, Kronos Incorporated

Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager

P10: INTERVIEW Sameer Paigankar MD, Lavue Pharmaceuticals

LEGAL FRAMEWORK OF PV FOR MEDICINES MARKETED WITHIN THE COUNTRY

ACG SHOWCASES NEW FLEXIBLE ENGINEERING AND INSPECTIONS SOLUTIONS

OPTIMISING HOT MELT ADHESIVE USE IN PACKAGING OPERATIONS

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

BR Tipnis Manager

Express Pharma®

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

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

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EDITORâ&#x20AC;&#x2122;S NOTE

Cracking down on fake medicines

ne of the important proposals considered during the 79th Drug Technical Advisory Board (DTAB) meeting held on May 16 was the introduction of a trace and track feature on the top 300 pharmaceutical brands in the Indian pharma market on a test trial basis. The reasoning is that as these top 300 brands enjoy good brand recall and are repeatedly used by patients, counterfeiters would target these brands over others. Hence, the damage in terms of side effects of counterfeit medicines would be greater. Taking this forward, the Drug Controller General (India) Dr S Eswara Reddy called for a meeting with pharma companies whose brands made up this list on June 25 to discuss the modalities for implementing the DTAB decision. Based on the MAT data compiled by AIOCD AWACS, the list of companies is topped by Sun Pharma with 22 brands, while the Abbott Healthcare-Abbott India combine has 23 brands. Cipla has 17 brands on this list, while Alkem Laboratories, Pfizer, and Zydus Cadila have 15 brands each. Other prominent companies are GSK and Sanofi with 13 brands each, Aristo Pharma (12) and Mankind Pharma (9). Besides these big companies, many smaller companies have between 1-3 brands on this list. The test trial envisages that these companies would voluntarily include a unique code on each pack of these brands, which presumably can be scanned by consumers, and checked against a database via a call centre or messages. The move, though well intentioned, is bound to face some resistance. Firstly, for the industry, this would be an additional expense but one could argue that it was only a matter of time before patients, if not regulators, would demand such a feature. Secondly, industry observers point out that patient groups and consumer activists would raise objections that such a feature should be mandatory not just for the top 300 brands but for all brands. One could also question the rationale of choosing to do the trial using the criteria of which brands sell more, pointing out that some of these grossers would be multi-vitamins and supplements, which though vital, fall into the discretionary purchases rather than no-discretionary medicines like antibiotics, anti-malarials or anti-TB medication. What would protect patients who choose not to buy these brands, either because they are not brand conscious enough or choose a cheaper

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India will have to put in place a reliable and simple mechanisms to detect fake medicines in the domestic market. The question is, can we avoid the complexity and yet get reliability?

alternative? This is anyway the case in non-metro markets, where it is easier to pass off lookalikes. The DCG(I)'s office has clearly mentioned that these top 300 brands are merely a test trial. Therefore, it could be argued that based on the feedback and experience of this trial, trace and track could be introduced in a phase wise manner for all brands in the domestic market. If this would be too much of a financial burden for pharma companies, maybe we could adopt some of the proven successful measures in countries with similar resource crunch issues. For instance, some countries in Africa have chosen to prioritise track and track mechanisms for medicines in therapeutic areas where they have a high disease burden. Anti-malarials and antibiotics could fall in this category, as would anti-TB drugs. This would impact maximum patients and those with serious communicable ailments. The test trial can only go ahead once the logistics of providing a database of unique codes and a manned call centre or messenger service is in place. The June 25 meeting should hopefully throw some light on how the DCG(I) proposes to put this in place. Whatever system is used, it will have to be simple enough for consumers across India, non-metro areas included, to use. Unlike most countries, India chose to mandate track and trace for pharma exports before domestic products. This was presumably to exempt smaller pharma companies who only serve the domestic market. After all, putting in place such a system calls for massive capital expenditure. For instance, smaller companies with 1-3 brands in the top 300 brands list will have to put in place dedicated packaging lines for these product packs. While we await the outcome of the June 25 meeting, there is no doubt that at some point in time, India will have to put in place a reliable and simple mechanisms to detect fake medicines in the domestic market. The question is, can we avoid the complexity and yet get reliability? Any change is tough and will face resistance. Will good intentions carry the motion through? DCG(I) Dr Eswara Reddy has to be congratulated for taking the first step. After all, as a Chinese proverb goes, a journey of a thousand miles begins with a single step.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

Lavue is focussed on developing, sourcing and commercialising innovative ‘Eye Care’ products Sameer Paigankar, MD, Lavue Pharmaceuticals, speaks on the new concepts and approaches towards eyecare offered by Lavue, in an interaction with Swati Rana Brief us on the establishment of Lavue Pharmaceuticals. Lavue Pharmaceuticals, headquartered in Mumbai, is a speciality pharma company dedicated to ‘Eye Care’. Lavue is derived from French ‘La Vue’ which stands for ‘Vision’. We have been contemplating on the launch of an ophthalmology-specific organisation for over a few years now. Given my background of over 22 years in the pharma industry, with having successfully established drug discovery infrastructure, API business, entire generic R&D backend, launching new companies, new divisions and new products, I was in search of new healthcare areas, wherein technology and innovative ideas can make a positive difference to the treatment approach. This pursuit led us to eye care management, which has seen very few revolutionary changes over the past few decades. The genesis of Lavue thus arose from this desire to introduce new innovations for better disease management in ophthalmology. Lavue is focussed on developing, sourcing and commercialising innovative eye care products with novel ingredients, superior and safe formulations and

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world-class packaging. With a vision of, ‘Innovation for Improved Vision’, Lavue offers a host of products for a variety of eye conditions afflicting all components of the eye, from the front to the rear and more. How is the company achieving its vision of ‘Innovation for Improved Vision’? We have a multi-pronged approach towards realising our vision of, ‘Innovation for Improved Vision’. We have used innovative technologies to solve many formulation issues of commonly used eye drops. To cite a few examples, to improve retention of the eye drops on the ocular surface for better treatment outcomes, we have

We have ambitious plans to expand in both, range and reach, over the next five years

formulations for certain products in our range. This will give doctors the confidence to use our products safely in patients, even for a longer term. With our international collaborations, we are also offering some of the global

High-speed diverters

best approaches in eye are and eye health management in India. We are offering, for the first time in India, the concept of ‘disease-specific nutraceuticals’ for ophthalmic conditions. In product forms for oral use too, we have made a very

Track design flexibility

appealing difference. We have introduced ‘Gummies’ for the first time in ophthalmology, the delicious way to eye health. We have offered solutions for certain eye conditions that are looming large as major threats to mankind in the

Purely magnetic holding

ACOPOStrak Ultimate Production effectiveness www.br-automation.com/ACOPOStrak

used AHG Technology (Adhesive Hydro-Gel Technology). In another instance, we have overcome the issues with using eye drops as suspension with our innovative CDIC Technology and UFD Technology. Suspensions, as you are aware, when instilled in the eye tend to irritate the already irritated eye, leading thereby to more tearing and drug washout. Using special technologies, we have formulated two commonly use eye medications, Nepafenac-a NSAID for painful ocular conditions and Rebamipide – a mucin secretagogue for dry eye management as clear liquids. Secondly, all our eye drops are BAK-free. BAK is a

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commonly used preservative in eye drops. When used regularly, BAK can lead to many ocular complications, as BAK itself leads to inflammation and cytotoxicity. Using innovative approaches, we even have ‘PF – Preservative Free’

July 1-15, 2018

office.in@br-automation.com | +91-20-41478999

ROI

OEE TTM

Enabling the adaptive machine. Like no other transport system.

MARKET current digital era that we are living in. The concept of ‘Computer Vision Syndrome’ and the innovative treatment of the same with the two branded ingredients, Lutemax 2020 and AstaReal, is a totally new concept to Indian ophthalmologists. Likewise, in India, there were no eye health-specific formulation for children, despite the growing incidence of eye health issues in children due to changing life style issues such as poor nutrition, lack of outdoor play and digital overuse in the younger population. We have provided innovative solutions for both these issues with our Gummies, viz., Luteza for Computer Vision Syndrome in adults and Eysential-Kids for maintenance of eye health in growing children above five years of age. Tell us about the company’s international collaborations. We wanted to offer the world’s best ingredients to Indian patients, with an assurance of high grade active principles, reliable efficacy and safety which is backed by clinical trials and scientific evidence. For meeting this, we have technical collaborations with four international healthcare organisations from countries across the globe. Lavue is pleased to offer, for the first time in India, formulations with branded ingredients from reputed companies, including, OmniActive Health Technologies, USA for their Lutemax 2020, Fuji Chemical Industries Co., Japan for AstaReal, AnklamExtrakt, Germany for an innovative approach to dry eye management, Bitop, Germany for another innovative approach to dry eye management. I would like to know about the new concepts and new approaches in eye care offered by Lavue, that existing major players have not even looked at. We will begin with simple instances and progress to

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All our eye drops are BAK-free. BAK is a commonly used preservative in eye drops. When used regularly, BAK can lead to many ocular complications, as BAK itself leads to inflammation and cytotoxicity. Using innovative approaches, we even have ‘PF – Preservative Free’ formulations for certain products in our range more intricate issues that we have addressed. Look at the eye drop containers in the country. Majority of them are unchanged for over two to three decades. Patients have great difficulty in administering these drops by themselves and much of the drops end up getting wasted along the cheeks and nose of the patient, due to crude delivery of the drops. They flow far too easily and freely. We have introduced all our eye drop brands in the ‘Doctors’ pack’. In this pack, there is a microlitre controlled drop dispensing with only one drop at a time being dispensed, that too with controlled drop size. Another very small but critical area of concern which we have addressed is the piercing of the eye drop bottle nozzle. Despite all care taken in manufacturing and sterilising the eye drops, it is not uncommon to see patients use safety pins and needles to pierce the nozzle, in spite of a piercing device available in the cap, since most of the patients are not aware of the same. We have provided in the doctors’ pack, pre-punctured vials, that will eliminate the use of needles and safety pins! The American Academy of Ophthalmology (AAO) endorses the uniform use of a colour coding system for the caps and labels of topical ocular medications. This is a voluntary code to prevent serious adverse events resulting from patient’s difficulty in distinguishing among various ocular

medications. We have adopted this colour coding in all our label design, a distinction that was very well received by ophthalmologists. As mentioned earlier, all our products are BAK-free for better patient safety. Our technologically solutions to improve eye drop formulations, such as, offering clear solutions for drugs which were hitherto being offered as suspensions, also set us apart. Specific nutritional approach to eye conditions is yet another new concept we have brought in. Ophthalmologists have already acknowledged and appreciated the difference with our scientifically backed brands Luteza gummies, Eysential-Kids gummies, Ocusoothe capsules and Fortareds capsules for varying conditions of the eye. In future too, we will continue with this approach. How can we protect the eye from within? In case of eyes, the main approach has been topical, with the use of eye drops or ointments mainly. However, major advances in the scientific understanding of aetio-pathogenesis of diseases have lead to an increasing interest in a new area of research, viz., on the use of nutraceuticals for the prevention and management of eye conditions. One may wonder if diet can influence eye health or the progress of degenerative eye diseases. The impact of diet on eye health has

recently become of rapidly increasing interest to researchers studying a variety of ophthalmic disorders including among others, dry eye disease, cataract, macular degeneration and glaucoma. There is a high incidence of these chronic conditions, particularly in the elderly and each can severely affect quality of life and are expensive disabilities to manage often because of the external care required. The old dictum, ‘Prevention is better than cure’, is very apt in this situation. In many of the chronic conditions, the underlying causative mechanism includes the triad of oxidative stress, inflammation and apoptosis, all of which are amenable to modification using nutraceutical interventions. Compared to most other organs, the eye is particularly susceptible to oxidative damage due to its exposure to light and high metabolism. Recent literature indicates that nutrients important in vision health include vitamins and minerals with antioxidant functions besides carotenoids and natural herbal supplements. Our approach is to study these ocular conditions and present a disease-specific nutritional supplement to protect the eye from within. As the company is dedicated to eye care, tell us about the services and products offered by Lavue Pharmaceuticals. As mentioned earlier, Lavue

is focussed on offering innovative eye care products with novel ingredients, superior and safe formulations and world-class packaging. Our range of products includes state-ofthe-art solutions to widely prevalent conditions, such as, dry eye disease, agerelated macular degeneration, glaucoma, eye infections and inflammatory conditions, ocular allergies, besides offering a range of ‘Intra-operative consumables’ and for the first time in India, a spectrum of nutraceuticals with varying components to meet needs of specific eye conditions. With a firm commitment to preserve visual acuity and protecting against the rampant digital exposure induced eye damage across all ages, we also have a range of prophylactic nutraceuticals for children and adults. What is the company's roadmap for the next five years? We have ambitious plans to expand in both, range and reach, over the next five years. Our next focus will be to reach pan-India very soon and after adding a few more innovative products for dry eye disease management we will revolutionise the area of glaucoma care. Glaucoma is a very common condition in India, for which doctors are looking forward to newer treatment approaches. Subsequently, we will work on diabetic retinopathy too. As you are aware, India ranks No. 1 in the world in diabetes incidence and the complication of diabetic retinopathy is looming large ahead. Innovative approaches to these and other eye conditions are under evaluation. Over the next five years, we plan to emerge among the top ophthalmology companies in the country with our range of innovative products. We live by our slogan, ‘Lavue: The Future of Eyetech’. swati.rana@expressindia.com

MARKET PRE EVENTS

analytica Anacon India and India Lab Expo to be held in Hyderabad The event to be held from September 6-8, 2018 analytica Anacon India and India Lab Expo are Indiaâ&#x20AC;&#x2122;s largest and most important platform for the analysis, laboratory-technology and biotechnology market. They have the potential for more than 259 exhibitors and more than 7,714 visitors in three halls. The event will be held in Hyderabad from September 6-8, 2018. The event will focus on innovative and applied product and system solutions for laboratories in the industrial, research and science sectors. As the industryâ&#x20AC;&#x2122;s definitive forum, fair and confer-

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

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PharmaTech Expo 2018 & LabTech Expo 2018 to be held in Ahmedabad The event to be held from August 22-24, 2018 will see 200 exhibitors and 7000 visitors PHARMATECH Expo 2018 & LabTech Expo 2018, an international exhibition on pharma machinery, lab, analytical, pharma formulations, nutraceutical & packaging equipment, will be organised in Ahmedabad from August 2224, 2018. The event is dedicated to pharmaceutical innovation, technology and

knowledge, which will showcase the latest cutting-edge technologies needed to costeffectively develop and manufacture quality products. This year the focus will be on pharma manufacturing and processing technology, pharma systems and services, pharma formulation, nutraceutical, food and cosme-

ceuticals, and ayurveda. More than 200 exhibitors with 7000 visitors are going to take part in the event. A concurrent event will be held on lab analytical and biotech instruments. Exhibitor’s profile include processing plant and machineries, lab equipment, instruments and lab wares, biotechnology and clinical re-

search organisations, excipients and additives, healthcare products - ayurvedic and neutraceutical manufacturers, IPR standards and patent formulations bodies, trade associations, trade promotion bodies, software for pharma industry and management, packaging materials and machineries, water treatment,

waste water treatment and waste management, bulk drugs, intermediates and formulations, R&D, quality control laboratories, cosmetic and personal care, environment and pollution control bodies, safety equipment, track & trace solution and vision lnspection equipment. EP News Bureau

Healthcare Senate, coming soon The event to be held in New Delhi from July 12-14, 2018, will focus on ‘Healthcare 2.0: Strengthening Values for Sustainable Growth'

xpress Healthcare invites CXOs of hospital chains, medical directors, owners/ promoters of hospitals and diagnostic centres, consultants, thought leaders, industry stalwarts and domain experts to congregate at India's largest private sector business summit to prepare a blueprint based on values that will make healthcare organisations successful both in terms of profitability and goodwill. The first two editions of Healthcare Senate held in Hyderabad served an excellent platform for thought leaders, key decision makers, investors and budget holders to share and exchange strategies that are relevant to the fast changing healthcare environment as well as helpful in running sustainable, responsible and profitable businesses in India. All stakeholders therefore, came together to share their insights on business models that will work for India. The first edition focussed on ‘Value-based healthcare delivery’, while the second edition was ‘Building a future ready healthcare sector for India’.

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Taking these discussions further and in keeping with the rapidly changing healthcare business environment, Healthcare Senate's 3rd edition, to be held in New Delhi from July 12-14, 2018, will focus on 'Strengthening Values for Sustainable Growth'. The summit and its discussion will emphasise on inculcating the below mentioned core values that will lead healthcare business to create value for all.

Ingredients for a successful organisations: ◗ Integrity: There are no moral shortcuts in the game of business or life. It is the true mark of leadership and so healthcare organisations who wish for sustainable growth will have to instill this principle in all their business dealings; be it patients, employees or partners. Healthcare organisations which operate with integrity and honesty earn immense brand value. At H e a l t h c a re S e n at e 2 0 1 8 industry stalwarts will share their stories of success which speak of goodwill and profitability earned through integrity and honesty in business.

◗ Accountability: This is a virtue that healthcare organisations cannot overlook. Accountability entails the procedures and processes by which healthcare providers justify and take responsibility for their activities. Lack of accountability in healthcare therefore, can cause significant damage to organisations. It can erode quality of care, ruin an organisation’s reputation, and increase the risk of lawsuits. Experts, in their discussion, will deliberate on ways and means to improve accountability of care. ◗ Quality: Quality in healthcare should be more than making the best product or providing the best service. It should extend to every aspect of the business function. A company that recognises quality and strives for it daily has a profound sense of self-respect, pride in accomplishment, and attentiveness that positively affects every aspect of its business. At the conference, healthcare quality experts will share insights on how striving for quality facilitates organisations to improve efficiency and achieve profitable in the long run.

◗ Innovation driven: Industry leaders will explain how innovative companies deliver a consistent stream of market successes via successful businesses and products/services or improved processes that continuously translate market success into economic value. These companies enjoy a competitive advantage and achieve sustained growth. ◗ Adaptability: With changing business dynamics the challenge that healthcare organisations face is keeping pace with these changes. Organisations which can roll with change and still perform well are prime time players and will enjoy sustainable growth. The event will bring forth case studies of such companies which have gracefully accepted change and gained better outcomes. ◗ Strategic Partner Relationships: No business is successful if it is not built on values forged and strengthened by strategic partnerships. Here, experts will highlight the essentiality of striking sustainable partnerships which can help companies gain competitive advantage and credibility.

Topics to be covered during the event are: ◗ Healthcare 2.0: Creating value for all ◗ Creating an inclusive healthcare ecosystem for India ◗ NHPS: Building the right synergies ◗ Growth Agenda: The battle for sustained innovation leadership in healthcare ◗ Access strategies in a era of price control ◗ CEO Round table: Business culture: Why core values matter? ◗ Healthcare's unique treasury management challenge ◗ Regulating trade margins the do's and dont's On the side lines of Healthcare Senate 2018, Express Healthcare will also be hosting Radiology and Imaging conclave and the the Healthcare IT Senate. Both these knowledge platforms will gathers experts from the field of radiology and It to share in depth knowledge on the Future of radiology and the healthcare IT. Contact: Vinita Hassija Email:vinitahassija@gmail.com Phone no: 98205990053

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

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

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

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GLOBAL PACK 2018 Date: November 23-25, 2018 Venue: Labh Ganga Exhibition Centre, Indore, MP Summary: GLOBAL PACK 2018 is an International Trade Exhibition & Tech

Summit for the packaging material, machinery and ancillary industry. Organised by Integrral Business Exhibitions & Media in association with SIES School of Packaging, it is being designed to serve as a platform

for the packaging and printing industry, both in terms of business and technical content. Contact Email: info@ibem-india.com

cover )

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THE MAIN FOCUS

CELEBRATING FR&D LEADERSHIP Following the successful first edition of Formulation and Drug Delivery (FDD) Conclave, The Indian Express (P) Ltd and Express Pharma recently hosted its second edition with the theme â&#x20AC;&#x2DC;Expanding Horizons of FDD Research: Embracing complexity. Held at Novotel Airport, Hyderabad, FDD Conclave 2018 saw attendance from over 100 leading professionals in formulation development and drug delivery. This year, the first-of-itskind event, took a deeper dive into the FDD scientists' role as key gatekeepers of a company's future reputation and market leadership. It also honoured and acknowledged the leaders and gamechangers of this sector with FDD Leadership Awards Exclusive coverage inside...

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cover )

INAUGURALCEREMONY

DAY 1 15 JUNE, 2018

(L-R) Naga Prasad Vishnubhotla, Senior Vice President, Aurobindo Pharma; Pramod Pimplikar, Managing Director, Shalina Laboratories; Dr Girish Jain, Consultant; Himadri Sen, Chairman, STEERLife; Viveka Roychowdhury, Editor, Express Pharma, Suresh Pareek, Managing Director, Ideal Cures, and Vinod Kumar Arora, Principal Advisor, IGMPI at the lamp lighting ceremony to inaugurate FDD Conclave 2018

FDD CONCLAVE 2018 ◗ Welcome Address by Express Pharma ◗ Lamp Lighting Ceremony + Release of FDD Leadership Handbook 2018 ◗ KEYNOTE ADDRES: Embracing Complexity Through Drug Delivery Systems & Innovation ◗ PRODUCT LAUNCH: INSTACOAT QD and INSTACOAT T2F ◗ Quality by Design Steps for Implementation in Formulations ◗ Capsule-based Inhalation Drug Delivery Expanding Horizons ◗ AccelTRA- Primary Packaging Solutions for Generic Injectables ◗ PANEL DISCUSSION: Regulatory Pathways for Specialty/Complex Generics ◗ Networking FDD LEADERSHIP AWARDS NITE ◗ Welcome Address ◗ Address by Chief Guest ◗ Description of the Methodology of FDD Leadership Awards 2018 ◗ Presentation of Awards ◗ Vote of Thanks ◗ Networking Cocktail & Gala Dinner

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Release of FDD Leaders Handbook

fter the lamp lighting ceremony, the dignitaries also released the FDD Leaders Handbook. It features leading professionals in the field of formulation development and drug delivery who are ushering innovation and partnering progress in the Indian pharma industry. The book provides insights on the role of scientists and R&D heads, be it in the discovery and development of new,

better medicines, improving existing ones, or inventing leadingedge technologies for drug delivery. It is an initiative to comprehend and appreciate the individuals behind the scientists and provide role models for next-gen R&D leaders. The achievements of these stalwarts will undoubtedly inspire future generations to pursue research as a career choice.

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KEYNOTE ADDRESS: Embracing complexitythrough drug deliverysystems & innovation

elivering a key note address at FDD Conclave on ‘Embracing complexity through drug delivery systems & innovation’, Dr Praveen Khullar, Head of Global Development Centre, Group Sanofi, Goa started his session by giving a comparative analysis of global pharma markets and the Indian pharma industry alongwith growth forecasts. He highlighted that falling product pieplines, growing R&D costs, increased generic competition, competition in biosimilars, commercial complexity, pricing pressures, regulatory compliance etc. are current challenges

Adopt and encourage innovation to meet unmet needs, maximise efficacy, reduce dose,fuel product pipelines, improve patient compliance,and simplify therapeutic processes Dr Praveen Khullar, Dy Head of Industrial Development Centres EP+Gx (EM), GEM, IA Platform & Head of Global Development Centre, Group Sanofi, Goa

for pharma companies. He drew attention to windows of opportunities in the sec-

tor such as NDDS, major therapy areas, emerging markets, advancements in devices and biosimilars etc. He also emphasised on adopting and encouraging innovation to meet unmet needs, maximise efficacy, reducing dose and toxicity, fuel product pipelines, improve patient compliance and simplify therapeutic processes. Examining trends in formulation development and drug delivery, he said that incremental innovation by combination products represent an interesting growth opportunity. He ended his presentation with a EU/US comparison on application types and exclusivities.

QualitybyDesign: Step-by-step Implementation for Formulation Development

anjit Barshikar, QbD/cGMP Consultant & Member of Editorial Board, Journal of Generic Medicines, England gave a comprehensive presentation on the steps to implement Quality by Design in formulations. He detailed the importance and role of QbD in formulation development and drug delivery to ensure better product quality and thereby patient compliance. His session emphasised on not just quality by testing (QbT) of the final product but also quality by design (QbD) of the process, including sourcing input ingredients of the desired quality. He listed down six steps as a QbD road map for formulation development. The first step was creating a quality target product profile to define quality at-

tributes, prerequisites to deliver therapeutic benefit as per label claims. The second step is to identify Critical Quality Attributes (CQA) and determine the physical, chemical, biological, or microbiological property or characteristic that should be within appropriate limit to ensure desired product or raw material quality. The third step involves ranking critical process parameters and adopting them effectively to get the right impact in case of critical quality attributes. It requires initial risk assessment of the formulation variables justification to develop an effective control strategy. The next step is marking the design space in a way that it leaves room for innovation and at the same time provides

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Quaity by Design in formulation development and drug delivery has an important role in ensuring better product quality and thereby patient compliance Ranjit Barshikar QbD/cGMP Consultant & Member of Editorial Board, Journal of Generic Medicines

meaningful regulatory flexibility. The fifth step is devising an effective control strategy to ensure process performance

and product quality. The last one in Barshikar's list is life cycle management. Barshikar also elaborated on

USFDA requirements and the role of QbD in easing regulatory compliance. He ended his session by reiterating that QbD is about delivering a high quality product that meets customer’s need.

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cover ) Capsule-based Inhalation Drug Delivery: Expanding Horizons

he speaker briefed the audience on inhalation drug delivery and capsule based dry powder inhalation (cPDI). In his presentation, he stated that the global market for inhalation drug delivery systems was $38.1 billion in 2017 and is estimated to reach $47.0 billion by 2022. The market is growing at a CAGR of 12.5 per cent for the period of 2017-2022. Explaining the advantages of inhalation drug delivery, Dr Bhat said that it is a fast and an effective way of delivering medication locally to lungs and also for systemic administration. It is used extensively to treat respiratory conditions such as asthma and chronic obstructive pulmonary disease

The attraction of using a capsulebased DPI is its simplicity. cDPI has gained wide acceptance as an effective, non-invasive method for local and systemic delivery Dr Jnanadeva Bhat, General Manager – Product Development and New Product Offerings

(COPD). It is one of the effective delivery systems of drugs and biopharma products to treat pulmonary/non-pul-

monary diseases. He also explained the advantages of cPDI to treat pulmonary diseases. The at-

traction of using a capsulebased DPI is its simplicity, he informed. He further briefed the audience on the features

of DPI capsules such as enhanced drug effectiveness, designed for maximum dose delivery; compliant with strict microbial limits with all global regulatory guidelines; minimises powder adhesion to capsule walls for consistent dose deposition; desired and custom sizes for low-dose APIs; optimised puncturing and cutting performance etc. Concluding his session, he stated that his company’s focus is on accelerated R&D on inhalation delivery systems because of their potential to produce maximum therapeutic benefits with targeted delivery to patients. He also reiterated that cDPI has gained wide acceptance as an effective, non-invasive method for local and systemic delivery.

AccelTRA- PrimaryPackaging Solutions for Generic Injectables

lok Chandorkar, Market Development Manager-India, West Pharmaceutical Packaging India gave a presentation on 'Your Partner for Integrated Containment and Delivery Solutions' at FDD Conclave 2018. He briefed the audience on range of the products offered by his company and said that West Contract Manufacturing Solution is the largest manufacturers of auto-injectors in the world. He also informed that the company has FDA-accredited labs in US which specialise in subjects like extractable, leachable and other studies. Speaking on integrated containment and delivery, Chandorkar informed about packaging components, Daikyo solutions, delivery systems, contract manufacturing, analytical services and partnership.

20 EXPRESS PHARMA July 1-15, 2018

He highlighted that the company has built an internal knowledge management portal, because of which it is able to give rapid response to queries raised by scientists. This knowledge management centre is also available online so that customers are able to get instant responses. The topics covered by the portal include product drawing; biologics containment delivery; fill-finish manufacturing technology; functionality and performance; surface properties and enhancement; material properties; industry trends, formulation characteristics etc. He also spoke on generic market insights and trends and shared four major insights: ◗ The ANDA fillings and approvals are increasing. Since, 2015 there has been a 84 per cent increase in ANDA filing

Aprimary containment delivery partner should have quality, speed and simplicity in its portfolio and West Pharma’s solutions are based on these aspects Alok Chandorkar, Market Development Manager-India, West Pharmaceutical Packaging India

and the approvals have increased by 53 per cent. ◗ Speed for filing packaging requirements has intensified; ◗ Market volatility for generic manufacturers can be

significant and ◗ Enforcement actions have increased since 2015 and multiple review cycles add stress to quality in operations and filings. He said that these insights

have taught that a primary containment delivery partner should have quality, speed and simplicity in its portfolio. He also claimed that the latest programme of West stands on these three pillars. He ended the session by briefing on West's new product AccelTRA.

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Product launch byIdeal Cures: INSTACOATQD and INSTACOATT2F

he final segment on the first day of FDD Conclave was a very interactive and interesting product launch. Suresh Pareek, Managing Director,Ideal Cures and Sanjay Negi, Deputy General Manager Technical Services, Ideal Cures gave an effective demonstration of how their coating systems, INSTACOAT QD and INSTACOAT T2F enable fast release and thereby increase the efficacy of the drugs. The audience got a chance to check out the benefits of these products first-hand through a small experiment.

Audience at FDD Conclave 2018 interacting and checking out the products lauched by Ideal Cures

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cover ) PANELDISCUSSION: RegulatoryPathways for Specialty/ComplexGenerics

he first panel discussion at FDD Conclave 2018 was on Regulatory Pathways for Specialty/Complex Generics. The panel was moderated by Dr Vinay Nayak, Executive Director, Marksans Pharma . Dr Rakesh kumar Bhasin, VP Generic Formulation, Biocon; Dr Raveendra Pai, VP, Formulation Development, Glenmark Pharma; Munish Talwar, VP, Pharma Research, Lupin and Dr Pawan Bhat, Executive VP, Technical Operations, Natco Pharma were the panelists. Dr Nayak gave an overview on the subject at hand and said that it is difficult to establish complex generics’ therapeutic equivalence as defined in the traditional generic medicines of the orange book. Some clinical studies and safety profiles need to be done at much higher levels to establish these complex generics. The complexities in these medicines can be in the form of APIs, formulations, devices, capsules, or drug delivery system.” Dr Pai elaborated on the definition and classification of complex generics and briefed the audience on the challenges involved in the development of complex generics. He said, “There are challenges related to time, cost and risks.” He informed that moreover, because of their complex nature, FDA or other regulatory agencies also become more particular about scrutinising the dossier. Often, there is a lack of guidance from the regulatory agencies, especially related to new molecules, which makes it difficult for the development of complex generics. Therefore, companies need to identify new commercial strategies aided by regulatory strategies

22 EXPRESS PHARMA July 1-15, 2018

(L-R) Dr Pawan Bhat, Executive VP, Technical Operations, Natco Pharma; Dr Raveendra Pai, Vice President, Formulation Development, Glenmark Pharma; Dr Vinay Nayak, Executive Director, Marksans Pharma; Dr Rakesh Kumar Bhasin, VP-Generic Formulation, Biocon; and Munish Talwar, VP, Pharma Research, Lupin

The panelists discussed and deliberated on the strategies for complex generics, choosing effective regulatory pathways and challenges that need to be overcome to beget success for targeted markets to address unmet patient needs. In other words, to work on complex generics, we should assist in creating regulatory strategies. Complex generics is about understanding the product, understanding the chem-

istry and a host of other things. Dr Bhat shared his experiences, case studies and challenges faced while developing complex generics. The major complication that he faced was the changing guidance by FDA periodically. Their expecta-

tions in terms of meeting their criteria of bioequivalence kept changing over time. However, the best thing is that FDA is providing a mechanism of preANDA meeting. This is a new concept for the industry.” Taking the discussion further, Dr Bhasin agreed with rest of the panelists that a major challenge in the development of complex generics is the regulatory pathway. He said, while working on complex generics it is better to be in touch with the FDA directly each time to get more clarity. He also informed that there are three important points to be considered while dealing with complex generics i.e.

formulation development, regulatory strategies and clinical endpipes. Talwar spoke on the complexity faced in the WHO markets and ROW markets. He said, “When we look at the US FDA there are clear defined guidelines but when we look at other markets the guidelines are not clear, so the complexity increases. The complexity for the formulators, apart from the regulatory pathways, start from the formulation itself.” The panelists further answered a few questions raised by the audience related to regulatory strategies and pre ANDA meeting.

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AN INTERACTIVE AND ENRAPT AUDIENCE AT FDD CONCLAVE 2018

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July 1-15, 2018

cover ) Vaccine Delivery- An Emerging Opportunity

ay 2 of FDD Conclave 2018, began with a very insightful session titled, ‘Vaccine Delivery - An Emerging Opportunity’. Dr Sukhjeet Singh, Chief Scientific Officer, Panacea Biotec, the speaker for this session and an industry veteran, highlighted the challenges, opportunities and market potential in the vaccine delivery sector. Giving a brief scenario of the global market for vaccines, Dr Singh informed, “At present, the worldwide vaccine market is at $6.50 billion and Indian market is at $900 million. The global human vaccines market is forecast to grow at a CAGR of 11.69 per cent during the period 2016-2020. India accounts for less than two per cent of the global market for vaccines. In India, the per capita spending on vaccines is extremely low, at $0.01, compared to $0.5 in China and $34.4 in the US.” However, through his presentation, it was also understood that in the

DAY 2 16 JUNE, 2018

FDD CONCLAVE 2018 ◗ Vaccine Delivery - An Emerging Opportunity ◗ PANEL DISCUSSION: Product Development Through Integrated Project Management ◗ Ideal Cures Documented Solutions Networking Tea Break ◗ PANEL DISCUSSION: 505(b)2: Avenues for Development ◗ Innovation in FDD: The Way Forward for India Pharma Inc ◗ Vote of Thanks ◗ Networking Lunch

24 EXPRESS PHARMA July 1-15, 2018

The future in vaccines involve developing and promoting cost effective options for vaccine manufacturing in developing countries

Sukhjeet Singh, Chief Scientific Officer, Panacea Biotec

recent decades, the number of private owned firms in India, active in the sector has grown rapidly. Their success in bringing low cost vaccine solutions to the public vaccine markets is an impor-

tant driver behind the emergence of the sector. Currently, diseases and viruses against which vaccines are being developed include, amongst others – rotavirus, Japanese Encephalitis, typhoid and malaria. Many more projects are at early stages, including efforts to combat dengue, Zika and chikungunya, informed Dr Singh. Further, he expounded on novel vaccine delivery systems (NVDS); Panacea’s innovative product EasySix, which is world’s first whole-cell (wP)

–based, fully liquid Hexavalent vaccine. While elaborating on different technologies used as a carrier in developing novel vaccines, Dr Singh also spoke on the advantages on thermostable vaccines. He said, “It reduces wastage of vaccines occurred due to lack of cold chain and decreases the cost of vaccine stockpiling. The product ensures vaccine stability in remote areas of the world with limited or no access to electricity for cold chain. Thermostable vaccines represent a better opportunity to increase the outreach of global immunisation programme.” Concluding his session, Dr Singh said that the future in vaccines involve developing and promoting cost effective options for vaccine manufacturing in developing countries. It also involves enhancing country’s capacity to use vaccines effectively. It is important to search for newer, safe and effective vaccines for diseases like malaria, tuberculosis and dengue as well.

Ideal Cures Document Solutions

uresh Pareek, MD Ideal Cures, the presenting partner at FDD Conclave 2018, showcased an interesting offering, Ideal Cures Documented Solutions, before the leading professionals gathered at the event. Calling it revolutionary, Pareek informed that it was an in-house developed program that converts a value proposition into monetary terms. Explaining further, he cited that if Ideal Cures claims that a particular product saves costs by reducing the time, then they are able to assign a monetary value to the savings via this program. Thus, the users of can directly measure savings offered by Ideal Cures’ solutions, for instance INSTACOAT. He also said that his team is in constant pursuit of measures which will add value to their customers. Pareek also claimed that the realised benefits of solutions from Ideal Cures are much more than the investments and went on to explain how they provide more benefits than even their in-house solutions. He listed down the advantages offered by his solutions such as dependable tech-

Ideal Cures is committed towards offering greatest value,convenience, time-savings which can be converted into more productivity, profit and choice

Suresh Pareek, MD, Ideal Cures

nical services; benefits of continuous research & development; no worry quality of raw materials; decrease in problems at shop floor; considerable time savings; decrease in rejections; and consistency in colour, uniformity and film thickness. Apart from these factors, he also high-

lighted that the accountability which Ideal Cures offers if there are glitches is also a major advantage. He also briefed the audience on the value additions offered by his company in multiple ways and reiterated that claimed that Ideal Cures is committed towards offering greatest value, convenience, time-savings which can be converted into more productivity and profit, as well as choice. He ended his session with the promise that Ideal Cures will be a committed partner to any pharma company’s progress.

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Panel Discussion: Product Development Through Integrated Project Management

he first panel discussion on Day 2 at FDD Conclave 2018 addressed the significance and need for integrated project management in formulation development and drug delivery. A distinguished panel comprising Subhadra Ummeda Group Head - Business Analytics Novartis Hyderabad; Dr Shirish Kulkarni, Sr VP-R&D, Sun Pharma; Sandhya Shenoy, AVP- R&D, FDC; Dr Sumedha Nadkar, Site Head and Senior Director, Perrigo Labs India participated in this discussion which was moderated by Dr Amit Biswas, Executive Vice President-Integrated Product Development, DRL. The discussion ranged from on horizontally and vertically integrated management for global product development, functional excellence in integrated project management to speed to the market, optimum resource utilisation and the role of data analytics in integrated project management. Dr Biswas commenced the discussion by expounding on the need to integrate project management in product development and the steps involved in doing so. He briefed the audience that integrated project management is a set of processes to ensure that all projects are managed properly. Project management in developing a product begins right from inception to commercialisation. He also said that one of the important aspects of integrated project management is taking the right decisions at the right time to help companies develop the product on time and help patients. Shenoy highlighted that cost and time are pivotal factors of product development and elaborated how project management helps in managing

(L-R)Subhadra Ummeda Group Head - Business Analytics Novartis Hyderabad; Sandhya Shenoy, AVP- R&D, FDC; Dr Amit Biswas, Executive Vice President-Integrated Product Development, DRL; Dr Shirish Kulkarni, Sr VP-R&D, Sun Pharma; and Dr Sumedha Nadkar, Site Head and Senior Director, Perrigo Labs India

these aspects. According to her, there are two factors for success: commitment to management and willingness of the team. She also advocated the need for collaborative and crossfunctional methods of working for effective product development to minimise and avoid errors. She also anticipated that once we start working in this manner each person feels accountable and responsible for executing the project. She also shared her learnings of working in collaboration, not only during the development of a product but also in the post development process. She also advised that having a plan is essential but sticking to the plan is challenging and hence the working conditions should be conducive to enable it. Nadkar emphasised on how co-locating the entire project

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and its operations is not always necessary in product development. She cited successful examples of effective product development. She also stressed that understanding and good communication skills is a must for any project manager of any product development process. Expressing views in an individual capacity, Kulkarni said, in India project development is still at a nascent stage. He also said that often project managers do not receive the due they deserve and pointed out that if anything goes wrong then the project manager is held responsible but in the case of success it is a considered a team effort. The audience also seemed to agree with this viewpoint. Sharing his experience in the US, he elaborated on the work culture and functioning mechanisms over there. He explained how each project had

a hierarchy and were done in a more systematic manner. He also pointed out the need for trained manpower in product development. Citing an example, he explained the important role played by a product manager when it came to regulatory filing and ensuring that the product reaches the market on time. He also mentioned that qualifications is important but not mandatory. More than education, he laid stress on the grasp of a subject and learning skills. He pointed out that a project manager needs to understand different tools of projects management in product development. Highlighting the importance of data analytics in project management, Ummeda informed that it enables the Indian pharma industry to collect data across many projects.

Reminiscing about her DRL days, she shared how they used to have knowledge system management, and how it was beneficial in collecting data from previous chemical reactions, pre formulation compatibility studies etc. She also informed that this data played a crucial role in fast track the projects. She pointed out that today there is a wealth of data is accumulated in Big Pharma companies which help in fast tracking the product development process. Ummeda also mentioned the relevance of data analytics in clinical trials conducted by these companies. The panelists also shared their views in developing effective project management strategies for product development. They also interacted with the audience to resolve their queries on this subject.

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July 1-15, 2018

cover ) PANELDISCUSSION: 505(b)2: Avenues for Development

he last panel discussion of FDD Conclave 2018 was on the topic, '505(b)2: Avenues for Development'. The panel for this session comprised prominent professionals in the formulation and drug delivery sector, Dr Himadri Sen, Chairman, (Moderator), STEERLife, Dr Rajeev Singh Raghuvanshi, Senior Vice-President and Global Head-CMC, Dr Reddy's Laboratories, Dr Girish Jain, Consultant, and Indu Bhushan, Chief Technology Officer, STEERLife on to the stage. As the title suggests, the discussion revolved around the 505(b)2 regulatory pathway and examined its ability and potential to streamline development and approval process, shorten development time, decrease costs, and the three to five years of market exclusivity that it offers to drug makers. Dr Sen, set the context for the discussion by highlighting that the pharma industry is now seeing unprecedented challenges and many earlier windows of opportunities do not exist any longer. He pointed out that now companies need to look at newer avenues of growth and navigate more effectively through regulatory pathways. He got the panelists to share their experience and learnings in developing strategies for smarter regulatory pathways, including 505(b)2. He also expertly steered the discussion through several pivotal aspects including strategies to move up the value chain through innovation and R&D. Invaluable insights on smarter regulatory pathways; extending exclusivity beyond norms for certain unmet medical needs and robust IP protections; moving from simple to complex strategies for better expected market realisation and complex generics for 505(b)2 consideration were also deliber-

26 EXPRESS PHARMA July 1-15, 2018

(L to R) Dr Girish Jain, Consultant, Indu Bhushan, Chief Technology Officer, Steerlife, Dr Himadri Sen, Chairman, STEERLife (Moderator) and Dr Rajeev Singh Raghuvanshi, Senior Vice-President and Global Head-CMC, Dr Reddy's Laboratories

ated and discoursed by the panelists. Bhushan pointed out several challenges before generics manufacturers and there are no clear regulatory pathways. However, he also believes that there are several new growth opportunities such as 505(b)2. He spoke on strategies to incentivise players in the sector in this area and encourage them towards innovation. He also elaborated on methods to extend the exclusivity period beyond what is mandatorily give by the FDA. Bhushan also gave examples of some billion dollar molecules, for e.g. Cifran from Ranbaxy, to explain how things have changed over the

years. He also urged India to make effective use of growth opportunities in 505(b)2. Raghuvanshi agreed that there are several areas of growth as far as 505(b)2 is concerned. However, he also cautioned about the need to be very careful as it is not easy to go down this path. He also said that it has become important to showcase a significant clinical advantage to get approvals and commercial success. He advised that there is a need to go back to their work and relook their current strategies to remove any shortcomings and develop an effective strategy to deliver a significant value additions to their products. He

shared a few examples of the challenges they encountered at DRL while working on products through 505(b)2 and how they were overcome. Raghuvanshi also said that we need to identify unmet medical needs and ideate to find solutions for them. This would be crucial in leveraging growth opportunities in 505(b)2. Dr Jain opined that the pharma sector in the country went down the generics route because it was easier. However, now the time has come to venture into more complex arenas and see the path of innovation for success. He informed that it is important to leverage the power of data effectively to

navigate the regulatory pathways successfully. He also highlighted that NCEs can also be filed as 505(b)2s. Urging the audience to read up all literature available on 505(b)2s, he said that this would enable them to find newer growth avenues and reduce any glitches as they seek approval from regulatory agencies. Thus, the panelists addressed various aspects connected to the issue and cited several pertinent examples to prove their points. But, they were unanimous in their opinion that 505(b)2s can offer a lot of growth potential to the Indian pharma sector, provided that it is leveraged effectively.

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Innovation in FDD: The wayforward for India Pharma Inc

he final presentation at FDD Conclave, titled 'Innovation in FDD: The way forward for India Pharma Inc', left the audience with a lot of food for thought. Dr Amit Biswas, Executive VP-Integrated Product Development, DRL, in this session, emphasised on the opportunities for ushering innovation in pharma formulation R&D. Referring to a McKinsey report, he informed that disruptions in four areas are changing the world. The first is urbanisation. Dr Biswas believes that many lifestyle diseases are due to urbanisation. The next disruption is technology. Dr Biswas

The role of formulation scientists is to bring innovation in medicines for global patients and create an ecosystem to foster innovation

Dr Amit Biswas, Executive VP-Integrated Product Development, DRL

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elaborated on how technology is impacting healthcare industry and medical research. The next disruption is an ageing world. Dr Biswas highlighted that as the population in India gradually ages, we will have to ensure that we have a healthcare system which will take care of their needs. The last disruption is global connectivity and its impact on healthcare.

He also touched on global trends in healthcare and the need for innovation. He opined that the pharma industry will remain R&D centric and the role of formulation scientists is to bring innovation in medicines for global patients. He left the audience with the idea that the way forward is to create an ecosystem to foster innovation.

EXPRESS PHARMA

July 1-15, 2018

cover ) GLIMPSES OF FDD CONCLAVE 2018

28 EXPRESS PHARMA July 1-15, 2018

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PARTNERS OF FDD CONCLAVE 2018

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EXPRESS PHARMA

July 1-15, 2018

cover )

Express Pharma hosts the second edition of FDD Leadership Awards Honours 21 R&D thought leaders and game changers for their significant contribution towards ushering innovation and progress in formulation development and drug delivery

Winners, Jury Members and Partners of FDD Conclave 2018

xpress Pharma, a leading publication from The Indian Express Group hosted the second edition of FDD Leadership Awards, held concurrently with the Formulation and Drug Delivery (FDD) Conclave 2018 at Novotel Airport, Hyderabad. Express Pharma was partnered by Ideal Cures in the endeavour to acknowledge and appreciate the role and importance of formulation development scientists in the progress of pharma sector. 21 professionals who are contributing signif-

30 EXPRESS PHARMA July 1-15, 2018

icantly to the growth of this sector were awarded across three categories â&#x20AC;&#x201C; Stalwarts, Leaders and Rising Stars. The evening began with a Welcome Address by Viveka Roychowdhury, Editor, Express Pharma who thanked all the delegates and speakers at FDD Conclave 2018 and took the audience through the vision and mission of FDD Leadership Awards. She emphasised that it was an initiative to ensure that formulation scientists receive their due and are recognised for their pivotal contribution to the

pharma industry. Next, Vinod Arora, Chairperson, Jury, FDD Leadership Awards and Principal Advisor, IGMPI took the stage to explain the methodology used to select the awardees. He also illuminated the audience on how the awards process was drafted and the efforts that went into choosing the deserving winners. He promised that in the coming years too, FDD Leadership Awards will continue to acknowledge the professionals behind the good work done in this sphere.

Dr Ravi Uday Bhaskar, Director General, Pharmexcil was the Chief Guest for the Awards Nite. In his address, he lauded Express Pharma for launching one-of-its-kind platform for formulation scientists. He also said that such platforms help to improve scientific temperament and encourage innovation in the sector. After his address, he joined Roychowdhury and Suresh Pareek, MD, Ideal Cures, for the awards presentation ceremony. Members of the Jury for FDD

Leadership Awards, Arora; Girish Jain, Consultant; and Pramod Pimplikar, MD, Shalina Laboratories as well as FDD Conclaveâ&#x20AC;&#x2122;s Scientific Committee member, Naga Prasad Vishnubhotla, Senior Vice President, Aurobindo Pharma; and industry veteran Himadri Sen were also part of awards presentation ceremony. Next, the Scientific Committee Members of FDD Conclave 2018 and the Jury Members of FDD Leadership Awards were felicitated for their contribution in making the event successful.

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WINNERS OF RISING STARS CATEGORY

Dr Bijay Kumar Padhi, Associate VP and Head-Product Development, Unichem Laboratories

Mr Elayaraja Natarajan, Associate Director - Formulation Development, Rubicon Research

Individuals contributing significantly towards the growth of formulation development and drug delivery were awarded across three categories â&#x20AC;&#x201C; Stalwarts, Leaders and Rising Stars Dr Pirthi Pal Singh, Associate Director, DRL

Dr Raveendra Pai, VP, Glenmark Pharmaceuticals

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Dr Venkata R Naidu, VP R&D, Intas Pharma

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July 1-15, 2018

cover ) WINNERS OF LEADERS CATEGORY

Dr Amit Mukharya, Associate VP, Amneal Pharmaceuticals

Mr Chandrasekhar Kandi, VP, Aurobindo Pharma

Mr Indu Bhushan, CTO & Director, STEERLife

Dr Kavita Inamdar, CTO, Indoco Remedies

Mr Kishor Deo, Senior VP, Biological E

Mr Krishnakant Gandhi, Director, DRL

32 EXPRESS PHARMA July 1-15, 2018

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WINNERS OF LEADERS CATEGORY

Dr Manutosh Acharya, VP R&D, OmniActive Health

Mr Munish Talwar, VP Pharma Research, Lupin

Mr Nitin Deshmukh, GM, Glenmark Pharma

Mr Pankaj Mandpe, VP, Micro Labs

Dr Praveen Khullar, Head of Global Development Centre, Group Sanofi Goa

Mr Rakesh Kumar Bhasin, Head-R&D, Biocon

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cover ) WINNERS OF STALWARTS CATEGORY

Dr Ashok Omray, Consultant

Dr Kaur Chand Jindal, Head R&D, Merial (A Sanofi Company)

Dr Milind Biyani, R&D Director, Aspire Advisors

Dr Sunilendu Roy, CEO, Ascent Innovative Medicines

FELICITATION OF JURY MEMBERS AND SCIETIFIC OMMITTEE MEMBERS

34 EXPRESS PHARMA July 1-15, 2018

MANAGEMENT I N T E R V I E W

Digital technologies are definitely important in ensuring compliance with GMP standards Pharma companies these days have to comply with a number of standards as governed by Good Manufacturing Practice (GMP) and FDA regulations as well as social audits. Often audit checks result in non compliance that organisations are seldom even aware of. James Thomas, Country Manager, Kronos Incorporated, in an interview with Raelene Kambli, explains ways and means by which companies can ensure compliance and audit securities What mistakes have you seen that pharma companies typically make in the area of compliance and auditing? The significance of regulatory bodies in compliance management for drug manufacturers was majorly introduced by international institutions like the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA). With CGMP and CF21 guidelines to processes in the pharmaceutical industry to be strictly followed, the sector has witnessed a serious compliance dimension to adherence, and audits. Internal and external audits are therefore becoming the order of the day, putting manufacturing plants through that, puts the entire organisation at risk of noncompliance as well as even becomes a reason for the shutting down of plants or entire operations itself. In India especially, compliance challenges are more often looked at in the manufacturing processes related to material, machines and the running of the plants from a quality perspective. Often, the people dimension is not given as much importance, while the reality is that there is a human involved in some stage of most of these processes

36 EXPRESS PHARMA July 1-15, 2018

where machine and material interface in a continuous process, be it generics or formulations. Even in the drug discovery and clinical phases, in R&D, scientists have a key role to play in driving through key R&D investments to successful trials and subsequent roll out to manufacturing. Intentional and unintentional mistakes from workforce personnel or compliance deviations can lead to serious repercussions. We see this lack of visibility and traceability to employees on the shop floor, be it on-roll employees or contract workers that are deployed in an area where issues creep in. Added to this, there is also aspects related to employee fatigue, safety, secured access, etc. which are also gap areas which causes issues for the pharma sector in running a compliance driven process end to end, which is auditable, traceable, and has the data integrity seamlessly. You say that compliance needs to be monitored more often and proactively so that audit checks happen smoothly. What role do mock inspections play in improving compliance? Monitoring compliance and adhering to regulations is the most significant rule for any

manufacturer to follow in this sector. Therefore, many companies have internal mock inspections that help them comply with the dictates of regulatory bodies. Mock inspections are mostly performed by an internal team using Food and Drug Administrationâ&#x20AC;&#x2122;s (FDA) procedures. As it is a simulation of the actual audits conducted by FDA to assess clinical and manufacturing practices, it helps pharma companies prepare for actual audits, assess and corrects compliance issues if any, and gives an idea on what audit inspectors would be looking for. This helps in identifying gaps early and setting them right pro-actively. An internal team of mock inspectors consists of qualified professionals with experience in regulatory compliance. Mock FDA audits are also employed by pharmaceutical companies to become certified in ISO and be qualified for a pre-approval inspection. What is the role and benefits of a pharmacovigilance audit in this aspect? Pharmacovigilance is known for drug safety related to the collection, detection, assessment, monitoring, and prevention of adverse effects of the drugs. It is formulated to

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focus on adverse drug reactions, therefore it is important that all pharma manufacturers go through pharmacovigilance audits, as it will review the quality management system currently used to collect, code and process data for case studies, and also assess compliance of the database with the current regulations. These measures are taken by manufacturers to monitor issues with medications more effectively and provide safer end products. Do you think digital technologies can play a significant role in enhancing GMP and compliance? Can you name some technologies in this regard? Digital technologies are definitely very important in ensuring compliance with GMP standards. In fact 21CFR part 11 itself is all about how digital records and electronic signatures can be used in place of handwritten signatures. Technology does play a very significant part in enabling traceability during the production process, which is one of the prime objectives of GMP. Initially the focus was around tracking the raw material and ingredients that went into a product, and over time, standards started developing around how the process itself was managed and the various controls around the process. One key area that most organisations these days focus is on the people element while tracking the whole activity. Who were the people on the production floor during the manufacturing process, when did they come in, who was authorised by whom, and similar such questions are being addressed by technologies like workforce management to enable a people traceability aspect to the entire process. Speaking about digital technologies, data integrity and validation becomes extremely crucial right? Digital technologies and validation have become pivotal for manufacturers to ensure compliance. Internal and external compliance validation of drug safety is critical for patient safety, as any defect in the proper functionality of the systems or non-compliance may have a direct impact on the safety of the patient. As many systems support regulated activities, compliance with local, state, national and international regulations are equally important. Tell us about some essential exercises that the companies need to do on a regular basis.

While great strides have been taken to tighten the processes around quality management, we must agree that in the pharma space there is still largely a scope for human error and that can be very damaging. A shift must happen where organisations look at the most dynamic part of the business which is the people element. There are many aspects to the people dimension. For example, understanding and controlling how people move in and out of your production area, and which is the security and safety aspect especially when you work with a fluid workforce like contract labour. Another aspect is around understanding if you had the right person for the job at the right time, essentially doing a skill match right down to the shift level. This is important because an unskilled or untrained persons can be one of the factors that contribute to a defective batch or maybe even a recall. Also, a lot of errors on the production floor happen due to inattention which can largely be attributed to fatigue. Managing fatigue is something more and more organisations in India are looking at, something we must learn from our European counterparts. How does Kronos' technologies ensure compliance and audit securities to companies? At Kronos, we believe in marrying people to processes, traceability, compliance and the framework around that. We are highly process-driven, and focus on recording, tracking and maintaining electronic data records on a regular basis. Keeping in mind the criticality of compliance and audit challenges in the pharma sector, we ensure visibility of operations in order to attain batch-to-batch accuracy. The idea here is to eliminate any gaps or vague areas in manufacturing in terms of the labour and value of labour involved. Adding to this, the CGMP and CFR 21 adherence is all about what we do â&#x20AC;&#x201C; connecting people to processes and managing them in a regulatory framework. Kronos helps pharma manufacturers identify and address two key issues â&#x20AC;&#x201C; the real time visibility on the workforce and their productivity in the production plant; and data traceability to gauge exact information (what, how and when) on the error that occurred in product or drug contamination. These measures by Kronos help companies to comply with the regulatory bodies and drive business outcomes. raelene.kambli@expressindia.com

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July 1-15, 2018

MANAGEMENT

Legal framework of PVfor medicines marketed in India Rajdutt Shekhar Singh, Partner, Singh & Associates, gives an insight on the status and objective of pharmacovigilance programme in India

s per the World Health Organization (WHO), Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala (WHO-Uppsala Monitoring Centre – WHO-UMC), WHO promotes PV at the country level. Currently, 131 countries are members of the WHO Programme for International Drug Monitoring. [1] The objective of PV is to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the riskbenefit profile of medicines.[2]

Pharmacovigilance programme of India India is a member of WHO Programme for International Drug Monitoring. The Central Drugs Standard Control Organisation (CDSCO), New Delhi, under the aegis of Ministry of Health & Family Welfare, initiated a nation-wide Pharmacovigilance Program of India (PvPI) in July 2010. The programme was launched with a broad objective to safeguard the health of 1.27 billion people of India. The Indian Pharmacopoeia Commission (IPC) acts as the National Coordinating Centre (NCC)-PvPI, where Adverse Drug Reactions (ADRs) are reported from all over the country. IPC also works in collaboration with the global ADR monitoring center (WHO-Uppsala Monitoring Centre (UMC)), Sweden to contribute to the global ADRs database. Spontaneous reports of ADRs due to use of medicines, vaccines, medical devices and herbal products from health-

38 EXPRESS PHARMA July 1-15, 2018

care professionals and consumers/patients are evaluated and corrected under PvPI. ADR Monitoring Centres (AMCs) have been set up all over India in order to monitor ADRs and reporting the same to NCC-PvPI. At present, 250 AMCs (medical colleges, district, and corporate hospitals, etc.) are enrolled under PvPI across the country. In addition, IPC issues monthly drug safety alerts, which includes riskprone drugs, based on the preliminary analysis of Suspected Unexpected Serious Adverse Reactions (SUSARs) from the PvPI database. It also advises professionals and patients/consumers to closely monitor and report the possibility of adverse events of notified drugs when such medicines are prescribed or consumed.[3]

Legal framework The Drugs and Cosmetics Act, 1940 (D&C Act) mandates pharmacovigilance and postmarketing surveillance. In cases of import, manufacturing of new drug, grant of the registration certificate, etc., the D&C Act states as follows: ◗ Permission to import finished formulation of a new drug (Form 45); Condition (5) [4] of Form 45 requires a Periodic Safety Update Report (PSUR) submission as one of the conditions for grant of permission to import the finished formulation of a new drug. ◗ Permission / Approval for the manufacture of new drug formulation (Form 46); Condition (5) of Form 46 also requires a PSUR submission. [5] ◗ Condition to report under the Registration Certificate (Form 41); whereas Condition (4) of Form 41 requires the manufacturer or his authorised agent in India to inform the licensing authority, in the event of any administrative action taken due to an adverse reaction.[6] ◗ Good Manufacturing Practice

Pharmacovigilance guidance document for Marketing Authorization Holders (MAHs)

(Schedule M): Paragraph 28 of Part 1 of Schedule M states that the serious adverse reaction should be reported to licensing authority by the licensee in the following manner: Paragraph 28 of Part 1 of Schedule M: Complaints and Adverse Reactions: I. All complaints thereof concerning product quality shall be carefully reviewed and recorded according to written procedures. Each complaint shall be investigated/evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained. II. Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority. III. There shall be written procedures describing the action to be taken, recall to be made of the defective product. ◗ Requirements and Guidelines for Permission to Import And / Or Manufacture of New Drugs for Sale or To Undertake Clinical Trial (Schedule Y); Condition (4) of Paragraph 3 (Studies in special populations) of Schedule Y requires the applicant to have a pharmacovigilance system in place.

In the pharmaceutical domain, a MAH is referred to a pharma company or sponsor of the product, who holds the license to market a particular product in the territory. In order to ensure smooth functioning of pharmacovigilance activities by pharma industries, in October 2017, the Secretary of the Ministry of Health and Family Welfare, Government of India, released the Pharmacovigilance Guidance Document (Guidance Document), effective from January 2018 for MAHs of pharma products. [7] The aforesaid guidance document (GD) had been developed by IPC (NCC-PvPI) in collaboration with CDSCO to provide assistance to MAHs for establishing and ensuring an effective PV system at their site. The GD comprises six modules viz. PV System master file, collection, processing and reporting of individual case safety reports, preparation and submission of periodic safety update report, quality management system at marketing authorisation holder organisation, audits and inspections of pharmacovigilance system at MAH organisation and submission of risk management plan. The GD directs MAHs to establish a PV system with a medical officer or a pharmacist who shall act as a PV officer-in-charge for collection and analysis of ADR reports related to pharma products marketed by them in India.

Conclusion The PV programme in India is regulated and operated by CDSCO, IPC, Drug Regulatory Authorities and the MAHs. NCCPvPI monitor the ADRs sighted in the Indian popula-

tion and helps the regulatory authorities in taking a decision for safe use of medicines. With the inclusion of the aforesaid GD, the identification, reporting, and mitigation of risks related to pharma products would be streamlined in a systematic manner.

References [1] https://www.who-umc.org/ global-pharmacovigilance/ members/ [2] http://www.who.int/medicines/areas/quality_safety/safety_ efficacy/pharmvigi/en/ [3] http://ipc.nic.in/ showfile. asp?lid=833&EncHid= [4] Condition (5) of Form 45-Postmarketing surveillance study shall be conducted during an initial period of two years of marketing of the new drug formulation, after getting the protocol and the names of the investigator duly approved by the Licensing Authority. [5] Condition (5) of Form 46Post-marketing surveillance study shall be conducted during an initial period of two years of marketing of the new drug formulation, after getting the protocol and the names of the investigator duly approved by the Licensing Authority. [6]Condition (4) of Form 41-[The manufacturer or his authorised agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorization, and/or not of standard quality report of any drug pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the drug is marketed/ sold or distributed…….] [7] http://www.ipc.gov.in/PvPI /pub/Guidance%20Document%20for%20Marketing%20A uthorization%20Holders.pdf

PHARMA ALLY VENDOR NEWS

Ideal Cures launches new film coating products at 2nd FDD Conclave INSTACOAT QD and INSTACOAT T2F are suited for pharmaceutical and nutraceutical applications

(From L-R) Sanjay Negi, DGM – Film Coating, Ideal Cures, Hemadri Sen, Chairman, STEER Life, Indu Bhushan, CTO – STEER Life and Suresh Pareek, Managing Director – Ideal Cures

deal Cures an Indian company headquartered in Mumbai, launched two of its new ready-to-use film coating products INSTACOAT QD and INSTACOAT T2F, suited for pharmaceutical and nutraceutical applications, at the 2nd Formulation and Drug Delivery Conclave organised by Express Pharma, held on June 15-16, 2018, at Hyderabad, India where more than 110 formulators of top

India based pharma companies were present. INSTACOAT QD, quick disintegrating film coating product is revolutionary for pharmaceutical and nutraceutical applications which provides fast disintegration of film and release of drug contained in the core within 3-15 seconds. There have been many speculations, questions and concerns about talc and titanium dioxide

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The products are completely free from Talc and TiO2

as being carcinogenic. Hence, the use of these ingredients is discouraged in Europe and US. Ideal Cures has come up with this brilliant ready to use coating product that is completely free from Talc and TiO2. These coatings are specifically formulated for pharmaceutical and nutraceutical products and provide easy scale-up and transfer to different manufacturing equipment.

Suresh Pareek, Managing Director, Ideal Cures and one of the inventors said, “Ideal Cures is driven by its vision to provide the best solutions to the industry by developing new products. With these products the company aims to add another brilliant milestone to its mission of assisting pharma industry with their need for better drug delivery and regulatory compliance.” EP News Bureau

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DECOpulse: Efficient and gentle, with greater production safety W

ith the DECOpulse, Metall+Plastic presented a new, innovative system to introduce H2O2 into isolators at the Achema show with the advantage of a decontamination cycle that is 50 per cent shorter. And, due to the reduced utilisation of H2O2, there is less strain on the material, substances and product. H2O2 is atomised through specific DECOpulse injection nozzles, producing a very fine spray. The nozzles have two channels on the inside to atomise the H2O2 with compressed air as a carrier gas directly inside the isolator. The relatively high inside pressure in very small droplets makes them evaporate very fast. Approximately 90 per cent of the DECOpulse droplets have a cross section of less than 1.5 micrometers and therefore, will evaporate several centimetres from the nozzle. The opening and closing of the valve for the liquid H2O2 is defined in quick and exact intervals, for example 100 milliseconds, that create a pulsing effect. This allows a very fine dosing of the introduced H2O2 amount. Due to the continuous supply of the nozzles with compressed air, turbulences prevail in the isolator. These turbulences ensure an excellent distribution of the released gaseous H2O2. Due to the excellent distribution of H2O2, the DECOpulse only requires a few injection nozzles (and piping).

Techniques at their best Besides the fine dosing, an additional benefit of the DECOpulse is that no H2O2 will be lost to decomposition, since no additional heating is required for the evaporation of the droplets. In addition, the system offers a higher injection rate per nozzle than common evaporation systems. Consequently, a faster H2O2 concentration and hence, a

40 EXPRESS PHARMA July 1-15, 2018

faster elimination of microorganisms is achieved. Subsequently less H2O2 has to be used for a complete bio-decontamination process, leading to a much

shorter decontamination cycle.

METALL+PLASTIC Clean room units for the aspetic production of pharmaceutical

products METALL+PLASTIC is a global leader in the design, manufacture, installation, qualification and validation of custom-de-

signed isolators. The company that was founded in 1957 as manufacturing isolators for customers working in laboratory animal science from 1960. This was followed later by the further development and production of isolation and containment technology for the pharmaceutical industry. METALL+PLASTIC set new standards from the very beginning and brought in innovations that offer many options for production. But priority is always given to the protection of the product, the operator and the environment. Unique and patented technologies, an orientation to meeting customer wishes and providing excellent service differentiate METALL+PLASTIC in this market. The range of products includes isolators for filling machines, sterility testing isolators, glove testing systems, H2O2 decontamination locks, electron accelerator for the "ebeam" sterilization system and gastight doors. The options for integration are extremely varied - whether for the filling of aseptic liquids or powders, in connection with e-beam tunnels, hot air tunnels, lyophilising units, autoclaves and other aseptic processing systems. Our intelligent process equipment markedly reduces process and shutdown times. In addition to leadership in this field of technology the many years of experience of the staff that numbers over a hundred forms the basis for continuous and successful growth. The Young-Laplace equation says, the smaller the droplet diameter, the higher the internal pressure. The greater the pressure, the more efficient the evaporation. Contact details OPTIMA packaging group Sabine Gauger Marketing Director sabine.gauger@optima-packaging.com www.optima-packaging.com

ACG showcases new flexible engineering and inspections solutions ACG, WORLD’S only integrated manufacturing solutions company for the pharmaceutical industry, will be showcasing its range of flexible Engineering and Inspections solutions at ACHEMA. ACHEMA is one of the largest international networking forums for the process industry. At ACHEMA 2018, visitors will witness the launch of the GT X.ONE granulation train, Protab 700 high speed tablet press and VeriShield CS16 tamper evident, Track & Trace solution. ◗ GT X.ONE is a state-of-the-art granulation system integrates the HSM X.ONE High Shear Mixer and FBE X.ONE Fluid Bed Systems, that match the re-

Visitors at ACG booth experience immersive virtual reality ride titled ‘Life of a tablet’@Achema

quirements of global standards including ATEX, CE, UL and GAMP 5. ◗ Protab 700 - a New Benchmark in high speed tabletting, is a double rotary bilayer tabletting machine that allows quicker changeovers. ◗ VeriShield CS 16 - an online

tamper evident labeling solution that incorporates serialisation print and inspection. The machine is compliant with EU FMD regulations and EU Annex 11 with CE certification. Richard Stedman, Group CEO, ACG Engineering said, “We are proud to bring these 3

important new products to the to the global market. Our focus has always been to deliver consistent product quality that meet international standards with excellent customer service. With our local support network in Europe, we are well equipped to cater to customers’ requirements across the European region.” Ettore Cucchetti, CEO- ACG Inspection added, “ACG is the only market-ready Track & Trace solutions provider in the world with L1 to L5 solutions capabilities. In April, 2017, ACG’s Inspection business acquired Croatia based IN2Trace - a world leader in pharmaceutical serialisation enterprise systems. The acquisition coupled

ACG launches market-ready comprehensive L1 to L5 solutions provider for traceability needs THE DIRECTORATE General of Foreign Trade (DGFT) has issued a mandate for any pharmaceutical organization manufacturing or distributing medicines in the Indian market, to comply with the Track & Trace regulations. As per the directive, it is vital for pharma organisations to find a market-ready implementation partner. Currently, ACG is the only marketready Track & Trace solutions provider in the world with L1 to L5 solutions capabilities that comply with the Indian regulations. ACG, the leading global supplier of integrated manufacturing solutions for pharma and nutraceutical companies, has developed modular customisable solutions from line-to repository levels through its Track & Trace business. ACG Inspection’s Verishield offers Level 1 to Level 5 solutions that include Level 5: Data Reporting to Gov-

ernment portals and Supply Chain Partners ACG Inspection’s solutions can support (a) country-specific data reporting functionality to the government portals and (b) sharing information between supply chain partners.

Level 4: Enterprise data management solution ACG Inspection’s solutions can host enterprise server on the cloud platform for multiple Marketing Authorisation Holder (MAH) plants, CMOs, and warehouses, who perform master data and production data management for global track & trace regulations.

line and batch management with ERP and LDAP integration to supporting all line level production activities for global track & trace regulations.

Level 2: Line Level Serialization and Aggregation Machines ACG Inspection can provide line level solutions supporting global track & trace regulations with product-wise number management through production orders-based workflow support. ACG Inspection can also help in executing serialisation and aggregation functionalities for multiple packaging levels.

Level 1: Unit Level Devices Level 3: Plant solution, CMO solution and Advanced warehousing ACG Inspection’s solutions can perform plant data management functionalities with master data management, production data management,

ACG Inspection’s solutions are equipped with devices and sensors for performing actions and manipulating the physical processes on the production lines. These devices include sensors and actuators in the machines.

with the opening of new office in Zagreb, has enabled ACG Inspection to expand its European footprint in the pharma Track & Trace business and to support the European marketing better.” ACG also featured the following products at the exhibition: ◗ Quest FB II - a 12 bar pressure shock resistant lab scale fluid bed processor ◗ A wide range of tablet tooling solutions - including multi-tip tooling, customised tooling, specialised tooling and tooling for specialised heat treatment ◗ AF 90 T - an automatic capsule filling machine series capable of filling various dosage forms into capsules, including powders, granules, pellets, tablets and micro capsules.

ACG uses immersive 4D technology and Virtual reality at ACHEMA2018 ACG RECENTLY presented its new product - GT X.ONE- an integrated granulation machine at ACHEMA 2018 using immersive Virtual reality. This zone is designed to give visitors a first-hand experience of the GT X.ONE granulation train in operation. GT X.ONE is a state-of-the-art granulation system that integrates the HSM X.ONE High Shear Mixer and FBE X.ONE Fluid Bed Systems and complies with global standards including ATEX, CE, UL and GAMP 5. Also forming a part of ACG’s booth exhibit at ACHEMA this year is a 6-seater 360 degrees 4D Virtual Reality ride which takes the visitors through an interactive experience of tablet-manufacturing process. Using this immersive technology, ACG will showcase a compelling adventure into the world of tablet manufacturing. The advance hydraulics of the ride ensures a roller-coaster ride like experience, that will make the customers tip from side-to-side and forward & backward, mimicking the movements of the powder or the tablet.

Contact details: press.office@acg-world.com, +91 8879793484 / +91 9871830883

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Gandhi Automations’clean room high speed doors a necessity BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which one can limit the amount of dust and dirt in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process. Clean rooms have become integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the doors which needs to be chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website : www.geapl.co.in

42 EXPRESS PHARMA July 1-15, 2018

PHARMA ALLY VALUE ADD

Optimising hot melt adhesive use in packaging operations Minimising waste while preserving bond and package integrity. An insight by Nordson Corporation RESOURCES ONCE considered endless are becoming both limited and costly. The manufacturing of typical EVA (Ethylene Vinyl Acetate) hot melt adhesives used in packaging, requires petroleum and its by products, currently in short supply and high demand. The factors responsible for adhesive availability issues are expected to continue for the long-foreseeable future.

Figure 1

Changes in the petrochemical industry While the impact of rising global demand and the cost of oil on EVA production have been evident for more than a decade, the abundance of new, lower-cost natural gas, extracted from shale, is having an equally profound impact on adhesive manufacturers. Both oil and natural gas are processed in a petrochemical operation called cracking. Petroleum cracking produces greater quantities of heavy byproducts/feedstocks used as tackifiers and waxes in EVA hot melts, polypropylene bottles, inks, and polyethylene films, to name a few. Natural gas cracking produces fewer heavy feedstocks but, more light feedstocks that are in very profitable and in high demand in a wide range of industries. As a result, petrochemical plants continue to re-tool with the objective of processing/cracking greater amounts of low-cost natural gas.

Increasing global demand The demand for feedstocks has never been greater and is expected to continue. High profit-margin consumer products like athletic shoes, vehicle tires, flexible packaging films, plastic bottles, baby diapers and other disposable hygiene products compete with adhesive manufacturers for the same raw materials, driving prices higher. Growing economies in China and India and emerging industries like

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solar energy, which uses similar polymers in the manufacture of photovoltaic cells, place even greater demand on already tight supply.

Adjusting to changing times What can packagers do to mitigate the increasing prices and decreasing availability of hot melt adhesives? The once-prevalent practice of placing more than enough adhesive on a package â&#x20AC;&#x201D; to assure a strong seal or bond â&#x20AC;&#x201D; is no longer feasible. Packagers must determine the exact amount of adhesive needed to produce a secure bond, then follow up by implementing dispensing technologies that will preserve the integrity of their processes and bottom lines.

Optimising adhesive use There is no magic to stretching, getting more mileage or sealing more packages per pound of adhesive. Rather, practical steps and the proper selection and use of dispensing equipment are the keys to success and savings.

Intermittent, modulated adhesive bead dispensing Packagers and packaging equipment manufacturers began experimenting with intermittent adhesive bead dispensing over a decade ago with moderate success in a variety of applications. Pattern controls, which manage the duration of dispensing applicator open and close times, determine adhesive bead length and are commonly employed in automated packaging lines. These controls can be programmed to replace long, continuous adhesive beads with shorter, intermittent beads in a process that was once referred to as stitching. The lack of widespread adoption of adhesive stitching throughout the packaging industry is thought to be attributable to:

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BOND STRENGTH Sample

Adhesive Type and Temperature

Bond Strength Solid Bead 1/8 in. dia. / .115g

Bond Strength. Intermittent Bead 1/8 in. dia / 0.08g

Intermittent Bead Bond Strength % vs. Solid Bead Bond Strength

Adhesive Weight Savings

Box A

3500 metallocene

8.33 lbf/g

8.11 lbf/g

97%

30%

Box B

250°

7.69 lbf/g

7.97 lbf/g

104%

26%

Box C

250°

9.73 lbf/g

9.96 lbf/g

102%

30%

8.58 lbf/g

8.68 lbf/g

101%

28.6%

Average

1. Abundant supplies of low-cost hot melt adhesives 2. Dispensing equipment limitations 3. Lack of data comparing the bond strength of long beads and shorter, intermittent beads Today, however, decreasing adhesive availability coupled with rising prices is driving renewed interest in intermittent dispensing technology.

Limitations of previous applicator technology Until recently, typical pneumatic hot melt adhesive dispensing applicator performance looked like this: ◗ Service life: 20 to 50 million cycles depending on adhesive type and application conditions ◗ Frequency of adjustment (average): 1.0 to 1.5 million cycles ◗ Speed/cycle rate: 15 to 20 ms ◗ Average dispensing linespeed capability: 15 meters/minute Using the photo (See Figure 1) as an example, a packager trying to reduce adhesive use, could replace 2 inch (51 mm) long beads with shorter, intermittent beads that will nearly touch when package flaps are compressed. Instead of a single open/close cycle, the adhesive applicator now cycles 4 times in the same 2-inch distance. Increasing the number of on/off cycles by 4X for every package previously caused unacceptable levels of applicator module replacement and

44 EXPRESS PHARMA July 1-15, 2018

downtime costs, nearly equal to the adhesive savings.

Improved dispensing technology enables adhesive savings To keep pace with advances in parent packaging machinery and industry demands for faster line speeds, greater flexibility, fewer maintenance requirements and less downtime, adhesive dispensing equipment and technology has progressed dramatically. Today’s best pneumatic applicators deliver speed and service life that rival electric applicators, at a fraction of the cost. ◗ Service life: 100+ million cycles depending on adhesive type and application conditions ◗ Frequency of adjustment (average): None ◗ Speed/cycle rate: 2 ms ◗ Average dispensing linespeed capability: 90 meters/minute The dramatic increase in service life, combined with eliminating the maintenance and downtime formerly associated with dispensing applicators and modules, has made intermittent adhesive bead dispensing both feasible and cost effective.

Bond strength: The hidden benefits of intermittent dispensing Seal integrity and adhesive bond strength are characteristics which packagers cannot sacrifice, even for the sake of adhesive savings. Recent testing proves what

Solid Bead

Intermittent Bead

Diameter

1/8 in. (0.125)

Length

2 in. long

1.4 total in. adhesive over 2 in. area

Space between beads

0.20 in

Adhesive Volume

.115 gram adhesive

0.08 gram adhesive

Bond Strength

Average 8.58 lbf (peak load) =100%

Average 8.68 lbf (peak load) = 101%

Adhesive reduction

—

Average 28.6%

Seal integrity and adhesive bond strength are characteristics which packagers cannot sacrifice, even for the sake of adhesive savings was once considered folly. That is, less adhesive, when dispensed in short, intermittent beads can equal the bond strength of longer beads that

use more adhesive. Because bonding is strongest at the beginning and end points of each adhesive bead, increasing the number of beginning and end points delivers greater bond strength, despite using less adhesive (see table/illustrations). Advanced dispensing technology using new adhesive applicators that provide both long life and consistent performance for intermittent bead dispensing is being adopted rapidly by packaging machinery manufacturers, adhesive suppliers and end users alike.

applicators which far outweighs the cost of maintenance, module replacement, inventory costs and downtime typically associated with older style applicators. Insulated, cool-touch dispensing applicators covers that reduce energy consumption up to 40 per cent. Speed/cycle rate capability over five times faster than older applicators allows packagers to achieve higher line speeds and maximise productivity.

Additional savings

In addition to adhesive optimisation achieved with intermittent dispensing, packagers will also realise cost savings from: The extended service life of new adhesive dispensing

Contact details Nordson India +91 80 4021 3600 or nordsonindia@nordson.com or visit www.nordsonadhesive.com

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Unlock the benefits of Nordson technology for efficient packaging Self-cleaning Nordson SureBead® applicators ensure clog-free operations, critical for tamper-evident closures. Some of the benefits are: Less maintenance and downtime costs • Achieve clog-free operation due to self-cleaning nozzles • Eliminate adhesive stringing • Obtain cleaner products, fewer rejects, less rework Significant cost savings on equipment • Change bead sizes without changing gun modules • Obtain fast and efficient bead changes due to removable nozzles • Achieve longer service life compared to standard pneumatic guns Up to 50% savings on adhesive use and costs • Achieve material savings due to sharp adhesive cut-off To learn more, visit www.nordson.com/surebead or call us at +91 80 4021 3600. Find us on:

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ªDry Non Sterile Wipes & Dry Sterile Wipes ªIPA Saturated Wipes

June Product Catalogue for free download look for JUNE4GMP

June Enterprises Pvt. Ltd. | www.june4gmp.com info@june4gmp.com | +91 9930359528

July 1-15, 2018

ISO 9001 - 2015 Certied

HVAC Clean Rooms Clean Room Equipments BMS & Electrical Regd ofce: F-62,Dreams The Mall, L.B.S Road, Bhandup(w), Mumbai-400 078 Corp. Off.: HVAX House, Bata Compound, Opp Viviana Mall, Khopat, Thane (W)- 400 601, India.Tel.: 022-21721115/16, Email: info@hvax.in Web: www.hvax.in

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July 1-15, 2018

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

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

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

Ÿ Dust Free & Fully Air Conditioned Factory Ÿ Fully Equipped Analytical Lab

SLITTER COATING LINE

Ÿ Producing 60 Micron PVC Film by Direct

Calendering without Stretching. Ÿ ISO 9001:2015 & ISO 15378:2017

Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area

LAMINATOR

Ÿ 6000 Sq. Mtr. Built-up Area

WE PACKAGE GOOD HEALTH. Corp. Oﬀ: 804, Siddhi Vinayak Tower B off. S.G. Highway, Makarba, Ahmedabad -380051 Factory: Chharodi - Sanand (Gujarat) +91 -9726430369 / 7433966038 info@uniworthllp.com • www.uniworthllp.com EXPRESS PHARMA

July 1-15, 2018

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July 1-15, 2018

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July 1-15, 2018

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To Advertise in

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

July 1-15, 2018

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