Express Pharma (Vol.13, No.22) September 16-30, 2018

VOL. 13 NO. 22 PAGES 64

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Management

Pharma licensing framework and the way forward

16-30 SEPTEMBER 2018, ` 40

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CONTENTS

FLYING IT FOR PHARMA

Vol.13 No.22 September 16-30, 2018

Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury*

The air cargo industry needs to up its game by ensuring reliability and safety across the supply chain to leverage the growth potential in pharma logistics| P14

BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Tanuvi Joe New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble Chief Designer Prasad Tate

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Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

RESEARCH

MARKET 4TH EDITION OF HEALTHCARE SABHA TO BE HELD IN NEW DELHI

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PHARMA LIFE

CPHI & P-MEC INDIA TO BE HELD IN DELHI NCR FROM DEC 12-14, 2018

MANAGEMENT

56 24

Senior Artist Rakesh Sharma

CHANGES DURING AGING IN ELDERLY PERSONS

LUPIN’S ‘LEARN AND EARN’ PROGRAMME TO TRAIN 1,000 GRADUATES BY 2020

PHARMA ALLY

Digital Team Viraj Mehta (Head of Internet ) Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis

Girish Arora

Ritu Hasija

Automation solutions for PHARMA industry

Sanjay Sharma

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PHARMA LICENSING FRAMEWORK AND THE WAY FORWARD

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PRE-AUTHORISATION REGULATORY GUIDANCE FOR THE MARKETING OF MEDICINES IN INDIA

www.br-automation.com

P28: INTERVIEW Gerhard Breu Chairman, Optima Pharma Division

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

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18.

Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world.

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

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EDITOR’S NOTE

Putting the bite into our laws

W

ith the recently released draft guidelines for e-pharmacies, policy makers have a good opportunity to shed light on all the grey areas in the pharma supply chain and create a more transparent ecosystem.

There seems to be the will to do this, but will policy makers find a way to plug all the loop holes? Or will it be yet another case of 'all bark and no bite'?

Unfortunately, the recent faulty hip implant episode proves that our laws have not evolved as fast as medical technology. A substantial number of patients who had undergone ASR hip implants made by DePuy International, a subsidiary of Johnson & Johnson (J&J), had to go in for revision surgeries when the implants started releasing metal ions into the surrounding tissues due to wear and tear as part of normal usage. Besides the physical distress and mounting medical bills of revision surgeries, they had to fight for their legal rights for fair compensation.

Even today, J&J is reportedly still trying to track down more than half of the patients in India who underwent ASR hip implants. While public outcry has forced action and compensation, though not of the magnitude awarded to similar cases in the US, we as a country need to introspect on our own shortcomings as well.

Our pharmacovigilance system definitely can be stronger. Secondly, the Drugs and Cosmetics Rules, 1945, does not expressly provide for compensation.

The good news is that perhaps regulators are being doubly cautious now. This is possibly why the National Coordination Centre - Materiovigilance Programme of India (NCC-MvPI) has extended the last date for sending suggestions/comments on the Draft Guidance Document for Medical Devices by almost a month from September 1 to September 25. Hopefully, compensation guidelines and redressal mechanisms are included in the revised draft for medical devices.

Policy makers and implementers thus need to incorporate these lessons into the draft rules for epharmacies which were released on August 28 and will be open for suggestions and comments for the next 45 days. The days ahead are likely see the noise on this issue escalate on both sides of the fence.

It is easy to understand why the stakes are so high.

According to the India Brand Equity Foundation (IBEF) website, medicine spending in India is expected to increase at 9-12 per cent CAGR between 2018-22 to $26-30 billion. Increasing consumer spending, rapid urbanisation, and raising healthcare insurance are some of the factors driving this trend.

Online pharmacies may currently have a relatively small slice of this pie, but it is only set to increase, fuelled by funding from PE and VCs. Just five of the larger e-pharmacies, from a cohort of 250 plus epharmacies, reportedly received funding to the tune of ` 1700 crores in the past five years.

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The recent faulty hip implant episode proves that our laws have not evolved as fast as medical technology

The turf war between the traditional brick and mortar pharmacies and e-pharmacies has thus been resurrected with a vengeance. The All India Organization of Chemists & Druggists (AIOCD) has called for all of its members to wear black ribbons on their shirts for a week, from September 20- 27, to protest against the online sale of medicines/ epharmacies. A note from AIOCD’s National President JS Shinde says that the protest will culminate with an all India chemists’ bandh on September 28.

The AIOCD campaign includes sending memoranda to the Prime Minister, all Members of Parliament, Ministers, Central Ministers, and other government officials stating their major concerns over the online sale of medicines as well as hold press conferences to get their message out in the media.

More of concern is the stated intent to hold protests at the taluka and district level.

On the face of it, online pharmacies seem to be a logical next step to online grocery shopping, especially with the push towards a Digital India, online payments etc. But for patients and their caregivers, buying medicines is not the same as a monthly/weekly stock up of household items. A consumer can make out when she receives stale produce but she will have to be made aware that checking the expiry dates of medicines, even if they are substantially discounted by the e-pharmacy, could mean the difference between life and death. So also, she needs to be educated about fake e-pharmacy sites as well as lookalike counterfeit medicines. At the other end, epharmacy staff need to be trained to spot fake prescriptions and raise the red flag for potential abuse.

There have been concerns that the rules for epharmacies might be lighter than for traditional pharmacies. For example, several other provisions of Rule 65 of Drugs & Cosmetics Rules 1945 reportedly do not find mention in the draft rules for e-pharmacies.

Industry observers like Raj Kumar Singla, former State Drugs Controller, Food & Drug Administration, Haryana, emphasise that there should be a ‘level playing field' for the chemist (who has a retail drug licence as per Form 20 & 21) and the e-pharmacy.

Also, the draft is silent on the jurisdiction of epharmacies, as unlike physical pharmacies, they are not bound by district, state or event country boundaries.

It is better to have some rules rather than none and all, and the draft rules are a good solid step in this direction. But policy makers need to address the finer nuances before the rules are finalised and put into action. Else we will have another tragic situation of toothless laws proving inadequate to protect patients' interest.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET EVENT BRIEFS 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, UK

4TH EDITION OF HEALTHCARE SABHA Date: October 5 and 6, 2018 Venue: Delhi Summary: Healthcare Sabha's 4th edition, organised by Express Healthcare, a publica-

CEO KENYA PHARMA EXPO 2018 E-mail: contact@ kenyapharmaexpo.com Website: www.Kenya PharmaExpo.com

GLOBAL PACK 2018

tion of the Indian Express Group, will bring together a think tank of policy experts, public health officials, and other key stakeholders to discuss and deliberate on these issues and come up with innovative strategies/solutions as the nation gears up for the most transformational moment in its public health journey. Healthcare Sabha’s 4th edition will focus on three core areas: Health

economics, equity and efficiency. Public health stalwarts will highlight the role of ethical practices in protecting patients of all socio-economic backgrounds.

Contact details Vinita Hassija vinitahassija@gmail.com

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

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 ofPackaging, 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

PRE EVENTS

4th edition of Healthcare Sabha to be held in New Delhi The event from October 5-6, 2018, will bring together a think tank of policy experts, public health officials, and other key stakeholders to discuss and deliberate on issues pertaining to healthcare and come up with innovative strategies/solutions

A

s India’s Public health Ecosystem rolls out Ayushman Bharat, the National Health Protection Mission (AB-NHPM), the Fourth Edition of Healthcare Sabha, invites Public Health Leaders to meet, deliberate and share their vision for 'Building The DNA For A Healthier Nation'. Healthcare Sabha's 4th edition, organised by Express Healthcare, a publication of the Indian Express Group, will bring together a think tank of policy experts, public health officials, and other key stakeholders to discuss and deliberate on these issues and come up with innovative strategies/solutions as the nation gears up for the

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most transformational moment in its public health journey.

Thus, with public health elevated as the foremost national priority, Healthcare Sabha's 4th edition will focus on three core areas: Health economics, equity and efficiency. Public health stalwarts will highlight the role of ethical practices in protecting patients of all socio-economic backgrounds.

◗ PPPs in healthcare: How can we strike the right balance? ◗ Ramping up health promotion: Dealing with India's dual disease burden ◗ State Health Financing v/s Central Insurance: What works best? ◗ New Age, New realities: The changing dynamics and priorities of Public Healthcare and methods to deal with it

Key topics to be discussed are

Delegates profile will include the following

◗ Health Economics, Equity and Efficiency: Where does India stand? ◗ Strategies for capacity building in public health

◗ Secretary, Addl. Secretary, Jt. Secretary, DG, DDG etc from Ministry of Health & Family Welfare, Government of India & various State Government

◗ NHM Mission Directors of various States ◗ NHM Policy Makers and Planning Officials ◗ Dignitaries from Central Drugs Standard Control Organisation (DCGI, Jt. Drugs Controller, Deputy Drugs Controller) ◗ Key dignitaries from NHSRC/SHSRC, NIHFW ◗ Dignitaries from State Health Corporations, State Health Society and State Health Mission Director ◗ Director, Deputy Director of autonomous institutions like AIIMS, JIPMER, PGIMER, NIMHANS etc. ◗ Dignitaries from ESIC (Director General, Medical Commi-

sioners, Deputy Medical Commisioners) ◗ DG - AFMS, Addl. DG-AFMS ◗ DG, ED, Director, Deputy Director - Railway Health Services, CMOs of various railway zones ◗ Chief Procurement Officer, medical superintendents, administrative heads of premier government and municipal hospitals from various states and cities To be held concurrently with Healthcare Sabha, the Express Public Health Awards will honour Champions, Visionaries and Game Changers in Public Healthcare.

EP News Bureau

CPhI & P-MEC India to be held in Delhi NCR from Dec 12-14,2018 UBM INDIA is all set to bring in the third edition of India Pharma Week (IPW), a week-long celebration packed with avant-garde events from December 10-14, 2018 alongside its flagship expo CPhI & P-MEC India. CPhI & PMEC India will be held in India Expo Mart, Greater Noida, Delhi NCR Unlike the previous editions organised in Mumbai across a number of venues, this year all the engagements of the IPW, which is also South Asia’s largest pharma event will be held at the world-class venue the India Expo Mart - Greater Noida, with all its attendant facilities. This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant umbrella for an entire week.

As the pharma industry is increasingly looking towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the perfect event for companies to pick up on the latest trends and innovations the market has to offer. Apart from India Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress, plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others. The ultimate goal of all these intertwined events is to help nurture a complete pharma ecosystem in India and better enable networking with the country’s corridors of power. P-MEC India will represent the platform where international and domestic pharma experts meet to to do business, network and shape the future of the Indian and South East Asian pharmaceutical industry.

Key reasons to attend P-MEC India ◗ Meet the biggest representation of pharma ingredients manufacturers in one single location ◗ Source high quality products at the most competitive price ◗ Network and do business with

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over 50,000 experts from 120+ countries ◗ Grow your client range and establish new business relationships Exhibitor’s profile include an-

alytical equipment, automation and robotics, batching systems/equipment, cleanroomequipment, filling equipment, filtration/separation/purification, health and safety

products,instruments, laboratory products and equipment, machinery, packaging equipment and supplies,plant/facility equipment, process automation and controls, processing equip-

ment, RFID, tabletting / capsule fillers, testing and measurement, validation.

Express Pharma is the media partner for the event.

EP News Bureau

cover )

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(

THE MAIN FOCUS

FLYING IT FOR PHARMA The air cargo industry needs to up its game by ensuring reliability and safety across the supply chain to leverage the growth potential in pharma logistics

By Lakshmipriya Nair

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cover ) T

he global pharmaceutical market is a rapidly expanding sphere. Reportedly, the demand for pharma products has doubled in the last decade and global sales in the sector are expected to reach $1.3 trillion in a few years. This, is turn, has accelerated the growth of the pharma logistics sector. A market research report from Technavio anticipate that this market will grow to $20.44 billion by 2021. Market analysts also predict that it will grow at a CAGR of 5.02 per cent during the period 2017-2021. This foretells a lot of growth potential for the logistics providers.

It’s no different for the air cargo industry. A report released by ICRA, in the latter part of 2017, forecasts that air cargo traffic in India is set to grow upto 60 per cent in the next five years to 4.7 million tonnes.

CRISIL Research also reveals that freight traffic at airports to grow by 11-13 per cent in FY2018, due to factors such as “expected revival in the global economy, domestic growth, increasing connectivity on account of air service agreements, and a booming e-commerce industry.”

Airways for pharma logistics The pharma industry often depends on airways to carry high-value, time and temperature sensitive cargo, especially vaccines. As Vikas Khatri, Founder, Aviral Consulting explains, “Normally air cargo is used more in case of cross border, temperature sensitive pharma shipments. Only in cases of high value pharma shipments, which are highly time critical, air mode is used.

Global potential of air freight for pharma shipments is substantially high, it’s almost three per cent of the air freight revenue of the aviation industry.”

The industry players also admit that the pharma sector is a major focus area for them.

Shankar Iyer, Head of Cargo Africa, Middle East & India,

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Pharma is now the global commodity of air freight industry since 2014 and is amongst the top revenue earners. Majority of pharma shipments flown by carriers are in the range of +15 to +25 per cent which is significant for their revenue Bharat J Thakkar Co-Founder & Joint MD, Zeus Air Services

Newer aircrafts, less carbon footprints, higher fuel efficiency, better infra to save time and fuel to get medicines from factory to airport etc. are crucial to improving delivery standards and efficacy of the air freight industry Rajiv Hariramani Vice President – Air Freight, Skyways Air Services

At Swiss WorldCargo, the shipment of pharma is one of our premier focuses, and we have always invested resources to fostering the safe shipment of life-saving products and other pharma throughout the world Shankar Iyer Head of Cargo Africa, Middle East & India, Swiss WorldCargo

In cases of high value pharma shipments, which are highly time critical, air mode is used. Global potential of air freight for pharma shipments is substantially high, it’s almost three per cent of the air freight revenue of the aviation industry Vikash Khatri Founder, Aviral Consulting

Swiss WorldCargo, Swiss International Air Lines informs, “Pharma shipments are of significant importance to the entire air cargo industry – both from a strategic point of view and as a source of revenue.”

Similarly, Rajiv Hariramani, Vice President – Air Freight, Skyways Air Services states that pharma shipments are definitely a very important source for top lines of the airfreight industry. He says that the nature of the cargo, need for temperature compliance, handling capability of the stakeholders and operational specialisation, all contribute to higher costs and ultimately higher revenues in comparison to other products/cargoes for the service provider.

Bharat Thakkar, CoFounder & Joint MD, Zeus Air Services explains, “Pharma is now the global commodity of air freight industry since 2014 and is amongst the top revenue earners. Majority of pharma shipments flown by carriers are in the range of +15 to + 25 per cent which is significant for their revenue.”

The growth potential of air cargo goes up considerably as the requirement for temperature-managed services is set to rise significantly. Air Transport Association (IATA) estimates that around $12 billion currently is being spent on cold chain biopharma logistics and believe that forecasts this figure will rise to a substantial $16.7 billion by 2020.

Moreover, Khatri reveals that the growth of pharma shipments through air is on positive mode with the emergence of biotechnology in pharma space.

Tackling challenges: Crucial to growth Yet, shipping pharma products come with significant challenges and require great care.

Unless pertinent and timely steps are taken to overcome challenges thrown up by inadequate know-how, poor infrastructure, inadequate facilities and increasing regulations, air-

( ways could lose out significant revenue to other modes of transport. An ICRA report released last year highlights that lack of adequate infrastructure could severely hamper the progress of the sector and predicts, “Cargo handling capacity at airports would need to be upgraded by around two million tonnes over the next five years.”

It has also been revealed that more than 50 per cent of all temperature excursions occur while products are in the hands of airlines and airports.

Companies have incurred a loss of millions of dollars in the case of large freight shipments. Khatri throws more light into this issue and says, “Temperature sensitive air cargo require consistency and uniformity across the supply chain. Only due to temperature excursion, the healthcare industry faces loss of $35 billion globally, out of which approximately $15 billion is product cost. Most of the losses incur due to change in command of shipment across supply chain.”

Giving more insight into challenges in air freight management of pharma shipments, Thakkar elaborates that the mismatch between the expectations and requirements of pharma shippers and the actual quality of received from the logistics service providers in the air cargo supply chain creates a high-risk situation and causes a number of temperature excursions.

Khatri points out to another challenge on the domestic front and informs that the capacity of air freight industry has increased through belly space of commercial flights, not through air freighters. Offloading in commercial flights and poor infrastructure at non-metro airports are a hindrance in the seamless flow of pharma shipments through air mode.

Moreover, the air freight industry is facing tough competition from ocean freight suppliers as they provide more economical means of

transport with efficient temperature control and reduced environmental impact. The past too has witnessed a decline in air cargo’s share of the global pharma product transport. As per IATA data, air cargo share of transporting global pharma products trans-

port declined from 17 per cent in 2000 to 11 per cent in 2013.

Thus, there are myriad factors that need to be considered while transporting pharma shipments. As an IATA document states, “Transporting healthcare products by air needs the establishment of

ADVANTAGE AIRWAYS ◗ Speed and efficiency cuts down transit times ◗ Apt for time and temperature sensitive shipments ◗ Better fiscal turnaround ◗ Sea freight limited to coasts ◗ Airfreight has more penetration capability

THE MAIN FOCUS

complex logistical methods to maintain a pharma shipment’s integrity. It requires specific equipment, storage facilities, harmonised handling procedures and, above all, strong cooperation among the cold chain partners.”

Likewise, pharma logistics suppliers have to adhere to the good distribution practice (GDP) guidelines of different countries and comply with national or local regulations of different geographies. Thus, it has become imperative for air freight suppliers and service providers to up their game.

So, how is the air cargo industry tackling these challenges to avoid a recurrence of such a scenario?

CHALLENGES FOR AIR CARGO STAKEHOLDERS ◗ Complex processes and specialised equipment ◗ Insufficient knowledge (or expertise) due to limited training opportunities ◗ Inadequate infrastructure or inadequately equipped facilities ◗ Increasing regulation around the world ◗ Multiple audits imposed by pharmaceutical companies and regulators ◗ Shippers experiencing difficulties in finding the right partners ◗ Increasing competition from other modes of transport

Source: CEIV

Steps to leverage growth opportunities Recognising the need for “a concentrated effort to improve the level of competency as well as operational and technical preparedness” in air transport of pharma shipments, the industry has taken some steps to enhance compliance, standardisation, accountability and transparency across the air transport supply chain.

The most notable among them is the creation of a Center of Excellence for Independent Validators (CEIV) in pharma logistics by IATA with an aim to “help the industry to improve the transport and handling of these products to meet the requirements of shippers and manufacturers”.

Likewise, the players too have understood the need to invest in enhancing transparency, data management and end-to-end compliance with regulations and are taking appropriate measures.

Iyer from Swiss WorldCargo informs, “At Swiss WorldCargo, the shipment of pharma is one of our premier focuses, and we have always invested resources to fostering the safe shipment of life-saving products and other pharma throughout the world. This

WHAT IS CEIV CERTIFICATION? IATA created the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma), to help organisations and the entire air cargo supply chain to get on the right track to achieve pharma handling excellence.

CEIV Pharma seeks to address industry’s need for more safety, security, compliance and efficiency, through creation of a globally consistent and recognised pharma product handling certification.

By establishing a common baseline from existing regulations and standards, this certification aims to ensure international and national compliance to safeguard product integrity while addressing specific air cargo needs.

CEIV Pharma encompasses many of the existing pharma standards and guidelines such as: ◗ IATATemperature Control Regulations (TCR) ◗ European Union Good Distribution Practices (EU GDP) ◗ World Health Organization Annex 5 (pdf) ◗ United States Pharmacopeia Standards Source: https://www.iata.org/

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cover ) includes maintaining ambitious quality standards, and adhering to strict, rigorous processes. By defining and maintaining these standards and processes, we are able to meet our customers’ needs, stimulate significant growth and create new revenue opportunities. And finally, with validations such as our recent CEIV certification, we can confirm our long-standing commitment to quality continues.”

Thakkar from Zeus Air Services apprises that his company has taken measures such as strengthening partnerships with all stakeholders, providing a 24x7 operation team, setting up a temperature-controlled warehouse near the airport/third party logistics GPL, setting up non-bonded faculties with 24/7

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WHAT IS TEMPERATURE CONTROL REGULATIONS? It is a comprehensive guide designed to enable stakeholders involved in the transport and handling of pharmaceutical product to safely meet the requirements.

The Temperature Control Regulations include: ◗ Up-to-date airline and government requirements pertaining to the transport of healthcare and pharma products ◗ Requirements on handling, marking and labelling ◗ Necessary packaging requirements ◗ Information on handling procedures ◗ The necessary documentation needed when transporting healthcare products Source: https://www.iata.org/ temperature-control, providing only controlled access, temperature and humidity indicators, enabling skilled and trained manpower to follow AEO GDP-

compliant processes throughout the supply chain etc.

Areas of improvement But the industry players are

also aware that there are many more areas that need improvement. Hariramani points out that newer aircrafts, less carbon footprints, higher fuel effi-

ciency, better infra to save time and fuel to get medicines from factory to airport etc. are crucial to improving the delivery standards and efficacy of the air freight industry. He also advocates on the importance of developing the peripheral aspects and minimising multi handling to keep the efficacy of the cargo intact.

Iyer underlines that more awareness and proficiency in handling pharma is key for the air cargo industry. This demands that all those involved in the logistics chain, be it packaging, warehousing, trucking, forwarding agents, airport terminal operators or airlines, must follow worldwide known standards of GDP and GMPs. Thakkar emphasises on the need to improve training in Temperature Control Regula-

( tions (TCR). A thorough understanding of these guidelines help addresses temperature management issues identified by the industry. This training provides knowledge about requirements and standards for transportation and handling of pharma products, including the compulsory use of the time and temperaturesensitive labels.

apps are offering users very relevant and significant features such as tracking of their shipments, alerts about temperature excursions, and sup-

port from cold chain experts.

The way forward Speed, efficiency and innovation will be crucial for meet

customers’ expectations and tackling challenges. Likewise, the future success of the air cargo industry, especially in the pharma industry would also

Tech route to progress Technology is another factor which is key to resolving a lot of bottlenecks and challenges hampering the growth of the pharma industry. Khatri elaborates, “With an increased number of biological drugs, efficiency and adherence to temperature will be more critical, as such drugs have shorter shelf life with more temperature adherence. Use of advanced technology can help the industry in efficiency improvement and service quality improvement.”

He also lists down a couple of technologies which are transforming pharma logistics: Block chain: It can bring multiple stakeholders on a single distributed ledger. These stakeholders will involve manufacturers, carriers, custom agents, custom departments, consignees etc. Live and distributed information can help better coordination between different agencies.

IOT and control towers: Use of IOT devices and monitoring through control tower will reduce probability of failures and also reduce service recovery time.

Some more interesting technologies include:

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Big data analytics: It is helping the logistics industry to identify gaps and loopholes, improve their operations, weed out counterfeits and prevent tampering among other benefits.

Mobile apps: Other technologies such as iOS and Android

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The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.

THE MAIN FOCUS

depend on collaborative efforts and sustainable partnerships between the various stakeholders of the air cargo industry. lakshmipriya.nair@expressindia.com

MANAGEMENT LEGAL EAGLE

Pharma licensing framework and the way forward Sanjay Sharma, Head-Lifesciences, NCF, UK; Ritu Hasija, Director Corporate and Girish Arora, Managing Director, Alniche Lifesciences, India elaborate on strategies to handle and execute pharma licensing effectively

L

icensing novel molecules and technologies is a relatively new-fangled phenomenon in the Indian Pharma Industry; however, it has now taken enormous importance in formulating new product strategy of pharma organisations that have aggressive growth plans at the global and national level.

Technically, licensing is the transfer of rights to a third party (the Licensee) to use the Intellectual Property owned by an innovator (the Licensor) under mutually agreed terms and conditions. Licensing can be for manufacturing and/or marketing rights in select geographies, renewable after the initially agreed period. This Intellectual Property offered by Licensor (Innovator) can be one of the following: ◗ A patent covering a product or process ◗ The right to the use of a trademark or brand name ◗ Copyright of process / technology ◗ Manufacturing know-how on products or processes (that is not the subject of a patent) ◗ Supply of API, semi-finished and finished formulation ◗ Technical advice and assistance including (occasionally) the supply of components, materials, etc. which may be required in the manufacturing process Based on the perspective, a licensing deal can be an Out-Licensing deal or an In-Licensing deal. In Out-Licensing, Licensor is 'out' - licensing its Intellectual Property to a third party (the Licensee) and for the third party (the Licensee), who takes 'In' the Intellectual Property, this becomes an In-Licensing deal.

In the space of development of NCEs, Indian generic players have been an out-licensing

20 EXPRESS PHARMA September 16-30, 2018

Girish Arora – Managing Director Alniche Lifesciences, India

Ritu Hasija – Director Corporate Alniche Lifesciences, India

Sanjay Sharma- Head (Lifesciences) NCF, UK

entity wherein they undertake to develop a technology/drug molecule up to a certain phase and then out-license this molecule to the targeted big pharma companies who might pay a development fee followed by a royalty on future sales, in case if the drug candidate is finally been commercialised. Though there are not many examples yet, Zydus Cadila, Dr Reddy’s, Glenmark and Sun Pharma have out-licensed a few NCEs. Of late, Indian pharma industry is experiencing renewed challenges that have significantly slackened the introduction of new molecules. These are largely posed by the new policy of Department of Pharmaceuticals (DOP) regarding fixed dose combinations (FDC), stricter processes of regulatory approvals of novel molecules, recognition of IP of innovator and MNCs’ fluctuating interest and adapting aggressive postures while introducing their patented molecules in India.

Thus domestic pharma companies in India sense the need for innovative strategies and models to keep meeting with

their growth aspirations.

Apart from various other plausible ways, Indian pharmacompanies have come to a realisation that in-licensing is one of the ways forward. Only a few pharma companies have taken full advantage of in-licensing opportunities and paved the way for their rapid growth in the competitive market. They have aligned the process with their long-term growth strategy. UK Modi group (Win Medicare, Modi-Mundipharma), Elder Pharma (acquired by Torrent Pharma), Walter Bushnell, Emcure, Alkem, Dr Reddy’s, Torrent, Glenmark, USV, Zydus Cadila, Cadila Pharma, Sun Pharma are some of the companies with an eye for such opportunities.

It is only recently that most of the companies have started understanding the long-term benefits of in-licensing, hence now mid-sized pharma companies and even start-up companies have become active in this new found area. Some of the notable examples are Zuventus, Khandelwal Labs, Alniche and others.

With this background, let's

address the core question: Why would a pharma company be interested to go for in-licensing?

This can be summarised as ◗ Address weak growth area(s)Therapy segments or geographies ◗ Acquire an existing base to build upon- technology, regulatory approvals, manufacturing, marketing ◗ Cost and time advantage- Licensing requires relatively smaller capital outlay with high ROI ◗ Need to consider cost of licensing vs cost of internal development ◗ Shortening the timeline to market entry and gaining advantage over the competitor and/or neutralise competitor’s move ◗ First to launch- Opportunity to launch a differentiated or specialised product in the market so as to first maintain or obtain critical competitive advantage ◗ Enhanced expertise- Gaining access to external expertise and capabilities (access to new drug delivery technologies, manufacturing process etc.)

◗ Global accessibility- Aligning with innovators helps domestic companies to expand their horizon, capability and global reach However, in-licensing does involve some risks and has a few disadvantages too. The innovator may lose control over the manufacturing and marketing of its IP. Licensing also may be less profitable as returns needs to be shared between two parties. There is even a risk that the licensee may sell a similar competitive product after the license agreement expires and efforts of Licensor go in vain. To most of the companies initial upfront fee becomes a speed breaker to kick start the process. Other risks and issues involve; speed of a partner, general uncertainties in doing business with a partner in unknown territory, language barrier, cultural differences, political risk, and currency fluctuations. Alternatives to licensing include exporting, acquisitions, establishing a wholly owned international subsidiary, franchising, and forming strategic alliances.

However, these are out of the purview of this article and can be discussed separately.

The approach to licensing is a well-drawn process, if followed serially, it brings predictable results. To handle this, large pharma companies have a dedicated business development department who scan the global markets for innovative and unique opportunities. In midsized or small or start-up companies, this activity is either carried out by marketing department or out-sourced to consulting firms who specialise in identifying in-licensing opportunities. They would typically adopt the following steps: 1. Lead generation- There can be various sources that support in generating licensing

opportunities like paid reports, tracking participating companies in conferences, company directory, online licensing sources, scientific discussion forum, daily alerts, newsletters, review articles etc. This helps in structuring a repository of targeted companies having intended IP. 2. Shortlisting- This is based on the strategic focus area(s) of the companies. It can be funnelled by applying various criteria – dosage form, molecule, geography, therapy focus etc.

3. One pager document- This is a crucial document presented by the company to the targeted company (Innovator) that helps in creating interest among the innovator company regarding opportunity for them.

4. Approach- Connecting with the key personnel in the target company (Head of BD &

Licensing, CSO, CEO, Sourcing or Procurement Head, Business unit or Country Head etc.) with ‘One Pager’ document.

5. Information package- Receiving the IM (Information Memorandum) or NCIP (Nonconfidential Information Package) by innovator company that will assist in preparing a comprehensive proposal which includes details about therapy focus, target market, competitors and commercial proposal plus other relevant details.

6. Signing confidential disclosure agreement (CDA) or non-disclosure agreement (NDA) - Though most of the points in a CDA or NDA remain neutral or standard, however country of jurisdiction always remains a point of debate. As a practice, it should be a neutral country that must be acceptable

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to both Licensor and Licence.

7. Business proposal- Receiving CIP (Confidential Information Package) or CIM (Confidential Information Memorandum) that will elaborate the previous business proposal and define the exact commercial terms and other relevant points that becomes the starting point for discussion leading to next step.

This business proposal should cover following points: ◗ Addressable market size (molecule, drug class, disease prevalence/incidence, competitors) ◗ Stage of development ◆ Pre-clinical (pre-IND) - Target selection & validation/Lead identification & optimisation, candidate selection, in-vitro studies & in-vivo studies / NonGLP/GLP studies (animal testing) etc. ◆ IND filed/IND approved/

Phase-I/Phase-II/PhaseIII/FDA review etc. ◗ SWOT of new product & targeted market (Therapeutic benefit over existing drugs: safety, efficacy, dosing, form, strength, route of administration etc.) ◗ COGS (cost of goods) or TP (Transfer Price) vs. expected price ◗ Potential market share (next five to 10 years) in the category & cash flow ◗ Further investment required (R&D, trials, marketing) ◗ Time to market (deal completion to commencement of sale) ◗ Feedback from KOLs, customers (understanding the requirement, benefit etc.) ◗ Distribution Channel (existing vs. new) ◗ Manpower requirement (existing field force vs. new field force) 8.

Non-binding offer

(termsheet) – This is a crucial step that incorporates broad commercial terms and other terms and conditions like details of licencing, territory, commercials (price, volume, payment terms, three to five year projections), duration of licence, mutual liability, force majeure etc.

8. Exchange of data- Once the non-binding termsheet is signed and exchanged, the process of due diligence starts that involves setting-up virtual data room, face-to-face meeting(s), onsite visit, interaction of technical and legal teams.

9. Deliberation on the agreement- The final phase in which all aspects of deal are captured and narrated in legal language.

The role of business development department becomes very central in defining and incorporating all terms & conditions in

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MANAGEMENT the definitive agreement.

10. Finally mutually agreed definitive agreement or MSA (Master Service Agreement) is signed and deal is sealed.

Once the definitive agreement is signed, regulatory and marketing teams become active so as to commercialise the IP at the earliest. The payment for the licensing can take any or a combination of the following: 1. One-time payment- Mainly

for finished formulation or technology transfer kinds of deals, based on five year revenue projections. It varies from one to five percent of cumulative sales 2. Upfront fees plus milestone payment- This applies when the deal includes further development of technology/ drug molecule since risks are involved in the final outcome 3. Upfront fees plus Milestone payment + Royalty (as a

percentage of sales)- As the above point however innovator wants to be involved in entire process of commercial launch thus expects a share in sales.

4. Upfront fees plus COGS (Cost of goods) plus Royalty Primarily when deal involves API. 5. Upfront fees plus Transfer price- When deal involves finished formulation to be imported.

6. Royalty payment (say 5 per cent to 10 per cent) of selling price to distributor/wholesaler/ consumer- mainly for finished formulations Most of the commercial terms involve upfront or licensing fee, however it depends on negotiations and mutual decision of involved companies.

To summarise the above, Licensing is an opportunity to infuse new IP in the organisation,

bring diversity in operations, boost the growth engine, supplement new revenue stream and enhance credibility of the organisation through their association with various partners. In today’s competitive scenario, BD team must structurally approach licensing as a well thought over strategy that will be imperative mainstay in placing their organisation ahead of the competition.

Pre-authorisation regulatory guidance for marketing of medicines in India Rajdutt Shekhar Singh, Partner, Singh & Associates, shares insights on ways to effective marketing strategy IN ORDER to persist in this highly competitive global pharmaceutical market, every organisation is required to have an effective marketing strategy and knowledge of various markets existing in the world. In this scenario, marketing of a medicinal product in India comprises regulatory compliances mandated by the Indian central regulating authority viz. Central Drug Standard Control Organisation (CDSCO) under the Drugs and Cosmetic Act, 1940 (Act) and Rules, 1945 (Rules) which evaluate the safety, efficacy and quality of drugs and also regulate their import, manufacturing, distribution, and sale in the country.

Any substance falling within the definition of ‘drug’ (Section 3 (b) of the Act) is required to be registered before importing and/or manufacturing in the country. In addition, manufacturing site (outside India) is also required to be registered.

Pre-approval stage checks Prior to seeking and thereupon being granted authorisation to manufacture and distribute a drug, an applicant must run a diligence check on certain frequently encountered issues, which may pertain to: Patent check: The applicant may need to check for patent affiliations that may be stemming from the drug being sought to be manufactured. In case of

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probable infringement, the applicant may need to apply for a license to use the patent from the owner or revise the production process. Further, if a novel technology is being employed for the manufacture of the drug, the applicant may also take steps to get the technology patented.

Price check: A fair evaluation of research and development (R&D) and other input costs will lead to the setting of a fair market price for the drug. This aspect is especially relevant when the drug in question is a life-saving medicine and is may be widely demanded by the public.

The Drug Price Control Order regulates the pricing of such pharma substances.

Marketing approval of drugs For obtaining permission to import or manufacture for the purpose of marketing of a drug product, an applicant is required to file an application in Form 44 along with prescribed fees in the form of treasury challan including all relevant data as per Schedule Y of the Act and results of clinical trials on local population, if needed.

Division of drugs for marketing approval: Drugs can be divided into the following groups based on data required for marketing approval: ◗ New chemical entity devel-

viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.

Pharma marketing practices in India

oped in India as an Investigational New Drugs (IND) and not marketed anywhere in world ◗ New chemical entity approved & marketed in other countries but not approved in India. ◗ New chemical entity being developed in other countries and not marketed anywhere in world ◗ Other drugs: In addition to the above, requisite approval is required to be undertaken from CDSCO (i) for the drugs which are already approved by CDSCO for certain claims, which are now proposed to be marketed with modified or new claims (ii) a Fixed Dose Combination (FDC) of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims,

Once the applicant receives marketing authorisation of a drug in India, it is also required to pursue a fair marketing practice and comply with regulatory compliances as described below: Pharmaceutical advertising: The mandate set by the Supreme Court in the case of Hamdard Dawakhana (Wakf) v.

Union of India and Ors makes it abundantly clear that commercial speech (in the form of advertisements), when pertaining to drugs and pharmaceutical products, must be cautiously aired. In light of the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, it was held that labels/instructions on medicine bottles commending the therapeutic efficacy and value of a drug were prohibited since the intent of such advertising was to lure consumers into self-treatment.

Similarly, the Rules (Form 44, Form 46 and item No. 3 of Appendix IA) also direct an Applicant to provide relevant promotional literature, package inserts and draft specimens of the labels and cartons in which drugs are proposed to be sold

for grant of authorisation to manufacture such drugs. The Drugs Controller General of India (DCGI) has also recommended the adoption of the selfregulation Code of the Advertising Standards Council of India with the objective of containing misleading and offensive ads. A recent advisory issued by the Ministry of Information and Broadcasting, with specific regard to ayurvedic and homeopathic medicines, directs television channels to comply with relevant laws and take off air, ads which promote self-medication and solution to health problems by self-proclaimed doctors and vaidhs.

Avoidance of unethical marketing practice: In order to curb unethical marketing practices for example luring of doctors to recommend a particular brand of drugs, by providing for paid trips often disguised as ‘educational conventions’ and other such incentives, the regulation for marketing practices (Uniform Code for Pharmaceuticals Marketing Practices), which is at present voluntary, will be made mandatory soon.

References 1. 1960 SCR (2) 671 2 https://www.ascionline.org/images/pdf/advisory-2-12.07.17.pdf 3. http://pharmaceuticals.gov.in/ sites/default/files/Uniform%20Cod e%20of%20Pharmaceuticals.pdf

RESEARCH INSIGHT

Changes during aging in elderly persons Dr Samir Mashelkar, Consultant-Life Science, Pharma,Biotech, discusses the damage caused by free radicals and how several heart conditions can be treated through antioxidant therapy

A

ntioxidants are those substances which inhibits oxidation or in biological terms removes harmful oxidising agents mostly free radicals , from the body of an organism. Free radicals are unstable substances which are uncharged,containing unpaired valency electrons and are highly reactive. They cause cell damage which are linked to a variety of chronic diseases, cancer and heart diseases .It is very important that a balance is maintained between antioxidants and free radicals for proper health.

tinuously produced as bi-products during cellular reactions in the body. Free radicals cause harm to cellular macromolecules like protein , DNA and cell menbranes by robbing their electrons by oxidation process thus causing oxidative damage. Free radicals reacts, mainly with the polyunsaturated fatty acids of cell membranes. The damage of polyunsaturated fatty acids is also called lipid peroxidation . It is very damaging as it is a continuous chain reaction.

Generation of free radicals

Anioxidants are substances which either lessen the formation of free radicals or neutralised them by reacting with them. Antioxidants usually donate an electron to the free radical. Once free radicals gets electrons , it forms an electron pair and gets stabilised and becomes harmless to the cells.

They are also therefore called scavengers of free radicals.

There are mainly three type

The formation of free radicals also known as reactive oxygen species starts with rapid acceptance of oxygen , setting up of NADPH oxidase , and the development of the superoxide anion radical. The superoxide anion radical is further converted to hydrogen peroxide.

The free radicals are also formed by combination of myeloperoxidase, halide and hydrogen peroxide system.

Myeloperoxidase in presence of chlorine converts hydrogen peroxide to hypochlorous ion which is a powerful oxidant.

The most probable reactive oxygen species are singlet oxygen , superoxide anion radical , hydroxyl radical, alkoxy radical, peroxy radical, hydrogen peroxide and lipid peroxide.

Also nitric acid synthetase produces peroxynitrite by reaction of nitric oxide with superoxide anion radical. Peroxynitrite is a very powerful oxidant and free radical.

How does free radicals cause damage to the cells?

Free radicals contains unpaired electrons and are con-

24 EXPRESS PHARMA September 16-30, 2018

How does antioxidants inhibit free radicals?

of antioxidants , namely, phytochemicals, vitamins, and enzymes.

A] Phytochemicals antioxidants These are compounds that occur in nature in the form of food of plants like in fruits, vegetables, whole grains, beans, nuts and seeds. In studies carried out in laboratories many phytochemicals were found to act as antioxidants which neutralised free radicals and protecting cells from getting damage. Some minerals like selenium directly blocks

the free radicals in the cells of the organism. Many phytochemicals with high antioxidant activity are not absorbed from the gut directly. Some helpful bacteria in the colon breaks down these phytochemcals and are later absorbed. Many phytochemicals help to maintain balance between themselves as antioxidants and free radicals in our body. Examples of phytochemicals are minerals such as copper, zinc, selenium along with substances such as theaflavin , gallate , allicin , piperine, curcumin, flavonoids. Theaflavin acts against hydrogen peroxide whereas gallate acts against hydroxyl groups and thus both acts as antioxidants. Allicin acts against peroxy radical and thus is an important antioxidant . Piperine and curcumin acts against hydroxyl radicals and thus are good antioxidants. Flavonoids reacts with hydrogen peroxides, hydroxyl groups and superoxide anion and thus are effective

antioxidants B]Vitamins antioxidants Vitamins are micronutrients which are required by the body in minute quantities for its proper functioning and are obtained from diet. There are two types of minerals namely, water soluble vitamins and lipid soluble vitamins.

There are total thirteen vitamins required by body for metabolism. They are namely vitamin A ( retinols), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B7(biotin), vitamin B9 (folic acid or folate), vitamin B12 (cobalamins), vitamin C (ascorbic acid), vitamin D (calciferols), vitamin E (tocopherols and tocotrienols) and vitamin K (quinones). Out of these vitamin A ( retinols), vitamin C (ascorbic acid), vitamin E (tocopherols and tocotrienols) act as antioxidants.

Vitamin E captures peroxyl radicals and thus prevent damage to cells. Studies have also shown that existence of an vitamins E regeneration mechanism which is important for its antioxidant function. Vitamin E is regenerated by vitamin C. Also vitamin C donates an electron to the lipid radical in order to end the lipid peroxidation chain reaction. Vitamin A quenches singlet oxygen thereby acting as antioxidant.

C] Enzymes antioxidantsThere are mainly three enzymes antioxidants namely, superoxide dismutase,catalase and glutathione peroxidase.

Superoxide dismutase are found in cytosol and mitochondria of the cell. They convert superoxide ion into hydrogen peroxide. Catalase is found in peroxisomes. This hydrogen peroxide is further converted to water by catalase. Glu-

tathione peroxidase is found in cytosol. It converts lipid hydroperoxides to their corresponding alcohols and also reduce free peroxide to water.

Thus all three enzymes superoxide dismutase ,catalase and glutathione peroxidase act as antioxidants and help the body to withstand oxidative stress caused due to free radicals.

Also there is presence of physiological antioxidants like uric acid and glutathione. Uric acid mainly from plasma is a strong remover of carban oriented radicals and peoxy radicals in presence of water contaning fluids. It destroys peroxynitrite with help of vitamins C along with thiols. Glutathione is present in cytosol and is in combination with other enzymes . Glutathione by its reactions helps to remove peroxides and thus act as effective antioxidants.

HEART The heart is a muscular organ which is located on left hand side and behind the breast bone. The heart pumps blood through its arteries and veins.

The whole network comprises of what is known as the cardiovascular system.

The heart comprises of four chambers. The first chamber is the right atrium which gets deoxygenated blood from the veins and sends it to the right ventricle. The second chamber is the right ventricle which gets deoxygenated blood from right atrium and sends it to the lungs which is full of oxygen.

The third chamber is the left atrium which gets oxygenated blood from the lungs and sends it to left ventricle. The fourth chamber is the left ventricle which sends oxygenated blood to the whole body. The vigorous pumping of blood by very

strong contractions creates blood pressure.

Arteries of heart Aorta- It is the largest artery of the body. It begins from left ventricle of the heart and runs down all the way till abdomen.

The aorta supplies oxygenated blood throughout the body.

Right coronary artery-It starts above the right cusp of the aortic valve and goes till right coronary sulcus. It supplies blood to the right ventricle. Left anterior desending artery-It is a branch of the left coronary artery that passes behind the pulmonary artery and ends up at the notch of the cardiac apex. The artery supplies blood to the anterolateral myocardium, apex, and interventricular septum.

Left coronary artery-It starts from the aorta and gives to the left side of the heart.

Circumflex branch of left coronary artery-It proceeds through the left part of the coronary sulcus and goes till posterior longitudinal sulcus.It gives blood to posterolateral left ventricle and the anterolateral papillary muscle .

Pulmonary artery-It starts at the base of the right ventricle and ends in lungs. It carries deoxygenated blood from the right side of the heart to the lungs. Posterior interventricular artery- This artery goes from the posterior interventricular sulcus to the apex of the heart. It carries blood to the posterior third of the interventricular septum.

Left marginal artery-It starts from the left atrioventricular sulcus and goes towards the apex of the heart and supplies blood to it. Sinoatrial nodal artery- It carries blood to the sinoatrial node

which is the natural pacemaker centre of the heart.

Veins of heartPulmonary veins- It begins from each lung helium and ends into left atrium. It carries blood from lungs to the heart.

Inferior vena cava-It begins behind the abdomen and ends in right atrium. It transport deoxygenated blood from middle-lower part of body to right atrium.

Superior vena cava-It starts from lower border of the first right costal cartilage and ends in right atrium. It transports deoxygenated blood from the upper half of the body to the right atrium.

Greater cardiac vein-It starts at the apex of the heart and ends to the base of the ventricles. It gets blood from the left atrium and sends it to left side of the heart.

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RESEARCH Jugular veins- It starts from dura mater and ends in right atrium. It carries deoxygenated blood from the head back to the heart.

Middle cardiac vein-It starts at the apex of the heart and ends in coronary sinus. It supplies blood from the heart to the extremeties of coronary sinus.

Left marginal vein-It starts from left atrium and ventricle and ends in left margins of the heart. It supplies blood from heart to the extremeties. Right marginal vein-It starts from inferior margin of the heart into the right atrium and supplies blood in similar way.

Axillary vein-It starts from lateral part of thorax, armpit and upper limbs and ends into the heart and also transports blood in the same way.

Different conditions of the heart Coronary artery disease-It is caused by narrowing of arteries by a cholesterol formation within the arteries leading to heart attack.

Stable angina pectoris-It is caused by lack of required oxygen when you strain yourself.

Unstable angina pectorisIt is caused due to not enough blood and oxygen due to narrowing of arteries.

Myocardial infarction-It is caused by sudden death of heart muscle due to lack of oxygen as a result of narrowing of arteries.

Arrhythmia-It is caused by abnormal electrical impulse to the heart affecting its rhythm.

Congestive heart failureIt is caused due to weaken heart as a result of difficulty in breathing.

Cardiomyopathy-It is caused due to widening of heart muscles.reducing heart blood driving ability.

Myocarditis-It is caused due to any infection to the heart muscles.

Pericarditis- It is caused due to any infection to the pericardium which lines the heart.

Pericardial effusion- It is caused due to abnormal accumulation of fluid in the pericardial cavity.

26 EXPRESS PHARMA September 16-30, 2018

Drugs like beta-blockers, angiotensin-converting enzyme inhibitors, calcium antagonists , and hydrogen-receptor antagonists tramp free radicals, stop lipid peroxidation and control changes in lipoproteins and thus act as antioxidants Atrial fibrillation- It is caused due to abnormal heartbeat as a result of improper electrical impulse.

Pulmonary embolism- It is caused due to blockage of one of the pulmonary arteries

In your lungs.

Heart valve disease- It is caused by defect in one of the four heart valves.

Endocarditis- It is caused by infection to inner lining of the heart .

Mitral valve prolapsed- It is caused by abnormal backward movement of mitral valve when blood passes through it .

Cardiac arrest- It is caused by sudden stoppage of functioning of the heart.

Free radicals in heart conditionsThe information has revealed that impairment in the myocardial cell as a result of ischemia and reperfusion may be caused by formation of harmful reaction oxygen species like superoxide radical, hydrogen peroxide, and the hydroxyl radical. The connection between free radicals in ischemia-reperfusion destruction is shown by observation of different methods.

Electron spin resonance procedure have shown high free radical formation in blood after reperfusion of affected part . Electron spin resonance procedure have also shown free radical production in blood of people subjected to coronary angioplasty. During cardiopulmonary bypass surgery also there is greater free radical levels in blood .Also there is lower activity of antioxidants plasma of blood as compared to high free radicals due to aortic declamping.

It has been suggested that there is imbalance between

high free radicals and low antioxidants during ischemia in heart tissue. This has been proved by factors that have an ability to influence antioxidant enzymes in the heart along with free radical removers, antioxidants and iron binding chemicals in reperfused muscle tissue of heart.

Also the actions of free radicals in reperfusion injury plays big role during fixing of cardiac surgery and heart transplantation.

Free radicals in reperfusion injury comes from inside the cells sources, like mitochondria and xanthine oxidase , or from externals origins, like neutrophils and macrophages.

Any damage to myocardial tissues causes release of iron ions that induces reactions of reactive oxygen species. Reactive oxygen species formed in mitochondria causes mutations in DNA and also harms its respiration chain process during myocardial infarction. Free radicals like hydrogen peroxide changes cell permeability and causes prostacyclin release which is vasodilator causing heart damage. Other free radicals changes lipids and proteins in membranes which results cell malfunction and heart tissue damage. Nitric oxide reaction with iron forms complex which affect mitochondrial chain and DNA nitration causing cardiac dysfunction. Nitric oxide along with peroxynitrite which it forms , results in cardiac malfunction.

Antioxidants in heart Security against free radicals by antioxidants in cardiac cells consists of four different portions of defensive activity which are in given order: preventive; chain breaking; repairing and adaptive.

The first part mostly includes enzymes whose enzymatic activity is controlled by presence of minute amount of minerals like manganese , copper , zinc and selenium.

These include enzymes superoxide dismutases, glutathione peroxidises and catalase.The first part is mainly involved with control of production and spread of initial free radical species which are formed from molecular oxygen.The second part is concerned with vitamins namely , two vitamins C and E and also has carotenoids which is involved in blocking spread of subordinate radicals caused by chain reaction due to lipid peroxidation, started and controlled by initial free radicals.The third part is by blocking enzymatically production of subordinate free radicals from chain reactions end compounds.

This allows ejection of molecules from the surrounding in which reactions involving metals may give rise to greater oxidative destruction.

In the end of antioxidant mechanisms adaptation takes place.

During this sequence , reactive oxygen species act as a sign for stimulating the formation and delivery of exact antioxidant to the area of required activity. Use of antioxidants in heart condition is done during production of excited radicals as well as during chain reaction. Laboratory invitro and invivo procedures along with epidemiological experience have shown contrasting association between extremity of oxidative reaction producing free radicals during heart diseases and antioxidant activity , indicating the importance of antioxidant to the heart.

Many natural and artifi-

cially produced antioxidant drugs along with additives for preventive as well as for curing purpose have been put forward. Small antioxidants molecules which are frequently used are a-tocopherol, ascorbic acid, carotenoids, coenzyme Q, uric acid, vitamin A, melatonin, lipoic acid and aminoindoles. Pharmacological antioxidants, such as flavonoids and polyphenols from plants are also in use. Artificially produced antioxidants which can be used are alpha –tocopherol analogs , phenolic antioxidants like Probucol and Nitecapone, 21-aminosteroids or lazaroids , thiol group containing compounds like thiazolidine , ebselen, dithiolethiones.

Also drugs like beta-blockers, angiotensin-converting enzyme inhibitors, calcium antagonists , and hydrogen-receptor antagonists tramp free radicals, stop lipid peroxidation and control changes in lipoproteins and thus act as antioxidants. Use of iron-chelators in animals myocardial infarction study have shown that it successfully prevents destruction by free radicals and thus act like antioxidant. Also it has been observed that there is some reduction in major adverse cardiovascular events when individuals were given diet supplemented with nuts or extra-virgin olive oil which may have antioxidant effect.Thus leading to the fact that food containing antioxidants reduces heart diseases.

Antoxidant therapy is now considered important for different heart conditions. We inferred that use of antioxidants needs more detail study to understand and know there pathophysiologoical role during different heart diseases and also need further research to identify new antioxidants.

References 1] Satish Balasaheb Nimse and Dilipkumar Pal . Free radicals, natural antioxidants, and their reaction mechanisms. RSC Adv.,2015, 5, 27986-28006.

2] Jasmina Mimic-Oka , Dragan V. Simic , Tatjana P. Simic FREE RADICALS IN CARDIOVASCULAR DISEASES . Medicine and Biology . Vol.6 , No 1, 1999 pp.

11 – 22.

RESEARCH UPDATE

Plasticell wins military contract to develop regenerative medicines for the battlefield Both trials are testing Xtandi in men with hormone-sensitive prostate cancer

STEVENAGE UK, 5 September 2018.

Plasticell, a developer of stem cell technologies and regenerative medicines, has announced that it has been contracted by the Ministry of Defence (MoD) in a pilot programme to develop regenerative medicines for the treatment of injuries resulting from combat or terrorism.

Plasticell will deploy its combinatorial stem cell screening platform, CombiCult, to develop technologies for the conversion of pluripotent stem cells into platelets that promote tissue recovery and regeneration.

“This defence-related work is an extension of Plasticell’s programme for manufacture of universal platelets from stem cells in vitro, to supplement or replace donor-derived material which is perishable and in short supply. Platelet transfusions are used in a number of medical applications but could also be used to treat individuals exposed to high levels of radiation from civilian, military or terrorist sources. In addition to their key role in blood clotting, platelets have been shown to promote wound healing, nerve regeneration and musculo-skeletal regeneration, all of which are especially relevant to recovery from various forms of battlefield injury,” commented Dr Yen Choo, founder

In addition to their key role in blood clotting, platelets have been shown to promote wound healing, nerve regeneration and musculo-skeletal regeneration and Executive Chairman, Plasticell.

As part of this programme, Plasticell will expand its existing collaboration on artificial platelet biology with Kings College London. The MoD’s Defence and Security Accelerator (DASA), which develops technological innovations that provide an advantage to defence and national security, will fund the research programme and if successful, may provide further support through to potential applications in the front line.

EP News Bureau

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PHARMA ALLY I N T E R V I E W

‘On the right track for the future’ What are the developments that set the trend for pharmaceutical filling and packaging machines? Gerhard Breu, Chairman, Optima Pharma Division, provides answers and explains what strategies he plans to use to face the current market requirements. An additional focus in the machine industry is digitalisation and its effects on the processes.

Optima is becoming a major provider of solutions and technologies for turnkey projects You started in July 2017 as an authorised representative for Optima Pharma. What are your responsibilities?

My responsibilities include the strategic development and implementation for Optima Pharma, as well as, the development and intensification of the collaboration between different locations. Therefore, we have a better understanding of the general context. The main benefit for our customers is that we can offer product portfolios that are adjusted to the entire process chain. It is also important to me that we strengthen the support for our customers worldwide – not only the deliveries, but also the local service for machines. We have reached our objective when the customer perceives it.

processes, in detail, at this year’s Achema show and we will present solutions under the motto ‘Smart Solutions for Pharma Experts.’

I am also impressed with the status of Optima Pharma’s digital engineering. Now is the time to apply it to projects to benefit our customers. This includes virtual reality technology for process simulations or virtual installations.

We also see ourselves as a system provider that is capable of delivering complete lines with a completely integrated FAT to ensure a fast and safe production start.

'The life cycle management will play a larger role' What are the developments that shape the current market for pharmaceutical filling and packaging lines?

Currently, we see a trend for more biotechnology products and individual therapies for patients. The variety of products increases drastically and many of them are very potent. Therefore, our machines have to be highly flexible to process these products, containers and batch sizes.

It has to be recognised that the life cycle of products will be much more dynamic and new product varieties and containers have to be processed. This calls for more flexible and reconfigurable

28 EXPRESS PHARMA September 16-30, 2018

solutions that will enable the life cycle management. We will definitely consider this during the conceptual design in order to meet customer requirements.

How does Optima Pharma react to this development?

I will give you two specific examples. The trend towards flexibility is solved with the utilisation of robots.

We are also developing a process solution for the isolator and freeze-drying field at the Metall+Plastic location in Radolfzell and at Optima Pharma in Mornshausen that will reduce the current cycle times.

Are there other trends?

We have a wide range of customers from small start-up companies to manufacturers of biosimiliars. Optima customers also include those that are highly specialised contract fillers to large pharmaceutical companies.

A keyword - Contract Filler - A start-up company describes Optima Pharma as the only vendor, worldwide, that is capable of supplying a machine that has the required flexibility.

Is this correct?

We are happy to hear that.

We, at Optima, believe that we are the market leader with our MultiUse system. This is not only a solution for contract fillers, but also for

those needing to process small batch sizes, require quick format changes and filling with minimum product loss in different containers.

These are all of interest for many of our customers.

'We see ourselves as an agile, platform based, customiser' What are the implications on the Optima Pharma process for the new market requirements?

Our processes adjust systematically to the new requirements. We see ourselves as an agile, platform-based customiser. I would even go as far as to say that customerspecific solutions are in our DNA. We will show our

Personalised medicine is getting more important and it is believed that the growth potential is increasing even more. How does Optima see that?

At Optima, we are building upon our existing knowledge. In the past one-and-a-half years, we have developed an extensive knowledge and understanding of the personalised medicine market. Due to our experts, we are able to react to the needs and requirements of the market. We are in close contact with our customers and are working together with them to develop market solutions to meet the demands of the market.

Does this mean you are interested in cultivating additional development partnerships?

Definitely, close collaboration benefits both sides. Together, we will be able to create optimum process safety and

productivity.

Are there markets you want to address more in the future?

Additionally, we will engage more in markets outside of Europe and North America. All product groups are equally important to us. In the future, we will not only be a mere machine vendor for certain applications but will focus more on processes and solutions for selected product groups and therapies. This is similar to a paradigm shift. We believe we mastered the machine technology pretty well. The next step will be to select the correct technologies and processes for new medical therapies. We are moving more into the position of a provider of integrated solutions than just a simple machine manufacturer.

Does this mean you will focus more on larger companies in the future?

Not at all. I am happy that Optima is working more and more with smaller companies.

This proves that we also have the correct solutions for small, specialised companies.

What are the areas in which Optima is well positioned and where do you see development potential?

Our increasing order volumes shows that we are on the right track. Team work is well pronounced at Optima Pharma; nevertheless, we are still striving to improve our collaborations with agile approaches. In addition, we will expand our production capacities at the location in Schwäbisch Hall. It is very important to satisfy new

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market requirements and to achieve faster installations.

Our technology centre will also be further developed in order to benefit our customers with process related procedures.

What distinguishes Optima Pharma from the competition?

We are the technology partner for companies working in new therapy fields. I believe we already have the complete machine range for this cliental.

We are the best-suited system provider offering fill and finish, isolator and lyophilisation technologies and solutions to meet complex challenges.

Therefore, I call us an agile, platform-based, customiser that understand small batch processes as well as large-scale production.

How does digitalisation influence the filling processes of pharmaceutical products?

Two big concerns of the pharmaceutical industry are ‘data integrity’ and ‘cyber security.’ Data integrity means the collection of data without redundant entries, to prohibit data manipulation and ensure data safety.

Another key item is the smart operator guidance. We support this with our TCAM system. Future machines will guide the operator and not vice versa. This will benefit pharma companies that do not have experienced personnel.

Shorter production cycles require the efficient planning of maintenance tasks that have to be executed more quickly. We also support the customer with our smart services that are combined under the lifecycle

management system ‘Optima Total Care.’

Another very important subject is data analytics. Here the question arises; how can we derive data from production samples? This data informs us how the quality of the product has changed or will change and how much high quality final product the machine produced.

That is especially important for small batch sizes where the focus is to minimise product loss as much as possible. These solutions are ideal for biotechnology products since they are such a rare commodity and product yield is of utmost importance.

We are on the right track at Optima Pharma to make progress in the market together with our customers.

EP News Bureau

EXPRESS PHARMA

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September 16-30, 2018

PHARMA ALLY VENDOR NEWS

Gerresheimer to showcase its Gx Solutions at PDA,Orlando,CPhI Worldwide,Madrid A specialised team to develop innovative pharma and biopharma primary packaging NEW SOPHISTICATED and sensitive injectable drugs require a new generation of custom-tailored pharmaceutical primary packaging. Gerresheimer is combining its expertise into a specialised team called Gx Solutions, an interdisciplinary expert and sales team able to utilise the development know-how of four technical competence centres. The result is new packaging solutions for sensitive agents, enabling safe administration and more efficient drug delivery systems. Gx Solutions particularly also offers tailored services for biotechnologically manufactured medications and for smaller and medium-sized biotech companies. At the PDA in Orlando at the Hotel Loews Royal Pacific on October 8 and 9, the team of experts will be on hand to speak to trade visitors for two days at booth 709.

Innovative medications are opening up new treatment options for illnesses, which were previously essentially untreatable. Agents are frequently produced using biotechnological means and utilise highly complex, protein-based molecules for the treatment of can-

Gerresheimer will also showcase its products and services at CPhI Worldwide in Madrid from October 9-11 at the Ifema fairground hall 4, booth C30 cer, neurological conditions and eye diseases. This makes these new medications so sensitive that they require a new generation of pharmaceutical primary packaging, such as prefillable syringes, vials and cartridges, to be reliably effective. As a result, medications and packaging are increasingly being developed simultaneously through joint efforts of pharmaceutical companies and packaging manufacturers to create an ideal comprehensive solution quickly and economically.

Gerresheimer is meeting this trend with a new internationally positioned team of experts. “With Gx Solutions, we have assembled an interdisciplinary team of specialists offering development expertise, international development ca-

pabilities and global regulatory expertise,” said Andreas Schütte, member of the Management Board and responsible for the Plastics & Devices division, Gerresheimer. This team of experts no longer thinks in terms of product groups or materials like plastics and glass for its work, but rather develops comprehensive solutions perfectly matched to the requirements of specific markets, applications and patient groups.

“Gx Solutions is able to utilise more than 430 product designers, engineers, technicians and skilled workers in the fields of plastics and glass at our Technical Competence Centers in Germany, the US and China,” explained Manfred Baumann, Global Executive Vice President, Sales & Mar-

keting, Administration & TCC, Management Board, Gerresheimer Regensburg. “The unit has everything from a quality laboratory to special machine construction to smallbatch production at its disposal, which we are able to utilise to produce samples for clinical testing. Thanks to our small-batch production capabilities for syringes, vials and cartridges, which will be established in Q3 2019, we will be able to respond to customer wishes quickly and flexibly.”

One area of Gx Solutions’ activity is the development of primary packaging, which interacts as little as possible with the medications it is filled with.

Special patented technologies for cone forming and interior coating have been developed for the prefillable Gx RTF sy-

ringes, for example. This makes it possible to offer Gx RTF syringes in silicone oil-reduced and metal-free versions. Prefillable syringes made of new and innovative materials like COP (Cyclic Olefin Polymer) plastics can also be produced. Solutions for increasing user safety and user friendliness, especially break-proof packaging, safety systems like Gx InnoSafe for the prevention of needle stick injuries and primary packaging for patients with limited motor capabilities are also important.

A third area of activity of Gx Solutions is packaging concepts, which are ideally matched to the development and production processes used by pharmacists. With Gerresheimer Gx RTF vials in the Ompi EZ-fill packaging format, identically packaged sterile injection bottles can be obtained from two different manufacturers.

Gerresheimer will also showcase its products and services at CPhI Worldwide in Madrid from October 9-11 at the Ifema fairground hall 4, booth C30.

EP News Bureau

Indore to host GLOBALPACK 2018 The event will be an exclusive exhibition and tech summit for the packaging industry GLOBAL PACK 2018, a leading exhibition and tech summit is being organised which is primarily designed to serve as a platform for the packaging and printing industry, both in terms of business and technical content bringing together national and international players under one roof. GLOBAL PACK

30 EXPRESS PHARMA September 16-30, 2018

2018 will take place betweenNovember 23 to 25, 2018 at Labhganga Exhibition Centre, Indore, Madhya Pradesh.

GLOBAL PACK 2018 is organised by Integrral Business Exhibition & Media in association with SIES School of Packaging and is backed by leading industry associations that in-

clude Association of Industries of Madhya Pradesh, Madhya Pradesh Corrugated Box Manufacturers’ Association, Madhya Pradesh Small Scale Drug Manufacturers’ Association, Indian Plastpack Forum, Pithampur Audhyogik Sangathan and Indore Master Printers Association.

GLOBAL PACK 2018 has connected and collaborated with potential partners with a sole purpose to successfully target the changing preferences of the customers along with the rapid growth and development in the FMCG and other industries like food and beverage, pharmaceutical, au-

tomobile and beyond.

A number of exhibitors from packaging machinery, packaging materials, printing, materials handling, food processing & packaging, pharma packaging, flexible packaging and eco-friendly packaging are participating in this event.

EP News Bureau

PHARMA ALLY

CPhI Annual Report expert warns ‘innovation is being hindered by regulators’ Girish Malhotra sees CDMOs as potential source of process innovation but warns both regulator and license holders the need to move past regulatory diktats CPHI WORLDWIDE the world’s largest pharma event – taking place in Madrid October (9-11) and organised by UBM (part of Informa) – has released the first part of its 6th Annual Report with a stark warning from Girish Malhotra, President, EPCOT International, that regulators are holding back the industry’s ability to innovate.

The report’s findings foresee regulators inducing ‘innovation inertia’ without a change of philosophy, but encouragingly — for contract service providers at ICSE — predict CDMOs can potentially form a key part of the solution, as they have strong economic incentives to innovate process and manufacturing improvements.

“The problem we face presently is that for manufactur-

ing technology innovations to be successful pharma companies (brand and generics)it needs to have an economic and commercial incentive. It is this incentive that drives forward innovation and advancement. But the regulators, in particular the FDA, are still dictating approaches to the industry without asking what the commercial justifications are to support them,” added Malhotra. Analysing the negative impact, Malhotra argues that if regulators do not stop dictating approaches, valuable process advances could potentially be lost. In his view, the cGMP practice guidelines essentially force a ‘cultural dogma’ in pharma companies, where their main aim is to meet regulations rather than to encourage to innovate.

He also questions whether these

recommendations are being introduced by people that have ‘hands on’ experience in process development, design, commercialisation and/or operation of pharmaceutical plants.

The report highlights that for pharma companies with patented products there is little incentive to innovate due to the short patent life after new drug discovery, ability to secure their demanded selling price and long approval times. However, Malhotra has suggested that by shortening approval times, companies will be incentivised to innovate, compete on a cost and quality basis, and allow them to capture a bigger market. Under his guidelines, not only would drug affordability improve, but drug shortages could also decrease, aligning with the manu-

facturing philosophy of maximising profits, whilst retaining product quality and safety.

Most promisingly, Malhotra suggests that with contract services increasing globally, and a little adjustment to the approval process, we could potentially create an entire sector innovating for its pharma customers and driving efficient manufacturing process. A new golden era of innovation and drug affordability.

“Overall my prediction is that whilst the regulators are trying to improve the situation, we will again lose any major manufacturing improvements over the next one or two years. In the longer term, however, I am hopeful the regulators will pass the buck to pharma and manufacturing companies and let market forces drive process innovation.

But my fear is that we are still at least three years away from this,” concluded Malhotra.

Tara Dougal, Head of content – Pharma, UBM, added, “This report highlights a number of important long-term issues for the industry and pharma manufacturers, suppliers and CDMOs – whose efforts to innovate in process development and formulation are often reported to be hampered by long regulatory pathways. It’s also why we have a number of experts presenting at CPhI this year to discuss how the regulators and industry should tackle process timelines, whilst safeguarding patients.

The agenda will also explore new manufacturing approaches, such as, continuous processing and QbD.” EP News Bureau

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EXPRESS PHARMA

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September 16-30, 2018

PHARMA ALLY

Lonza to reveal next-generation solution for Endotoxin Detection at PDA2018 Lonza experts will be available to consult with analysts on how automated endotoxin testing technology can help them streamline their QC testing processes LONZA WILL reveal its nextgeneration endotoxin automation solution, PyroTec Pro Robotic Solution at the Parenteral Drug Association (PDA) Global Conference on Pharmaceutical Microbiology from October 1516, in Bethesda, MD (USA). At Booth #308 Lonza experts will demonstrate how the company’s instruments, reagents and software are integrated into the robotic platform, providing a fully automated workflow solution.

Consistent with the FDA’s Process Analytical Technology (PAT) initiative, Lonza is introducing a new generation of automated endotoxin detection driven by its market leading WinKQCL Endotoxin Detection Software.

Attendees of the PDA can see Lonza’s PyroTec Pro Robotic Solution for endotoxin testing and talk directly to Lonza experts about the innovations in the new WinKQCL Software. A few of the highlighted features include: ◗ WinKQCL Software can generate robotic scripts and adapt to changing sample dilution requirements. ◗ The WinKQCL Software can control the procedure from start to finish. ◗ WinKQCL Software can import sample test worklists from a sample management system and export the results back out to the same system, preventing transcription errors and saving time over manually entering data.

During the PDA Endotoxins Workshop that follows the conference on October 17-18, Lonza will present a new poster demonstrating how automated endotoxin testing can reduce the potential for human error

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Consistent with the FDA’s Process Analytical Technology (PAT) initiative, Lonza is introducing a new generation of automated endotoxin detection driven by its market leading WinKQCL Endotoxin Detection Software substantially, enhancing the accuracy, reliability and traceability of results.

The presentation will also show how laboratories can maximise their return on investment through time and cost savings provided by automated endotoxin testing technology.

Titled 'The Automation of Endotoxin Testing: Streamlining Your QC Testing with Automated Endotoxin Testing and Process Optimisation', the poster will be presented by Robert Porzio, Product Manager at Lonza. He will explain how Lonza’s WinKQCL Endotoxin Automation Software Module can revolutionise the way endotoxin testing is being performed, allowing for an overall enhancement of lab efficiency and productivity. In addition to this presentation, Lonza experts will be available at Booth #7 to consult with analysts on how automated endotoxin testing technology can help them streamline their QC testing processes and better monitor endotoxin contamination.

“Our presentation at the Endotoxins Workshop highlights Lonza’s commitment to support QC testing labs with solutions that promote data integrity and

maximise productivity,” Porzio said. “At the same time, we will have experts on hand at Booth #7 to demonstrate how our wider endotoxin testing product offering can help our customers deliver the next high-quality, breakthrough products.”

PyroTec Pro Robotic Solution will be demonstrated: ◗ On October 15, from 11:45 am7:00 pm ◗ On October 16, from 9:45 am4:00 pm ◗ At Booth #308, in the exhibit area of the Bethesda North Marriott Hotel & Conference Center The poster presentation will be held: ◗ On October 17 and 18, from 3:30-4:00 pm ◗ In the exhibit area of the Bethesda North Marriott Hotel & Conference Center ◗ Lonza experts will be available at Booth #7 Further information can be found at Lonza Booth #308 at the PDA Global Conference on Pharmaceutical Microbiology or at Booth #7 during the PDA Endotoxins Workshop.

EP News Bureau

Waters Corporation, Restek Corporation in co-marketing agreement Under the terms of the agreement, Waters and Restek will work together to provide food safety laboratories with training and applications support of GC-MS methods and workflows for pesticide monitoring and screening WATERS CORPORATION and Restek Corporation have entered into a co-marketing agreement in an effort to give food safety laboratories access to the GC-MS instrumentation and consumables they need to perform pesticide residue GC-MS analyses and support a safe, secure, sustainable and nutritious global food supply.

“We are delighted to enter into this agreement with Restek. Like Waters, they are strongly committed to making customers successful and their market-leading GC consumables and technical support play an important role in helping our customers monitor for pesticides and other contaminants and meet the sensitivity requirements of global regulated methods,” said Jeff Mazzeo, Vice President, Marketing, Waters Corporation.

“Restek is excited to work with Waters on this new venture because we both place great value in bringing exceptional service and quality to our respective customers,” said Rick Lake, Vice President, Marketing, Restek Corporation.

Under the terms of the agreement, Waters and Restek will work together to provide food safety laboratories with training and applications support of GC-MS methods and workflows for pesticide monitoring and screening.

The Waters Xevo TQ-GC Mass Spectrometer is a tandem quadrupole mass spectrometer with an electron im-

The Waters Xevo TQ-GC Mass Spectrometer is a tandem quadrupole mass spectrometer with an electron impact (EI) ionisation source pact (EI) ionisation source.

When paired with highly-inert Rxi columns and Topaz liners from Restek, the Xevo TQ-GC Mass Spectrometer allows laboratories to meet and exceed low part-per-billion limits of detection when quantifying pesticide residues and other contaminants in food using GC-MS/MS methods set forth by worldwide regulatory agencies/authorities.

Waters is exhibiting the Xevo TQ-GC System at these international scientific conferences this week: 132 nd AOAC International Annual Meeting & Exposition and the 22 ndInternational Mass Spectrometry Conference (IMSC).

EP News Bureau

PHARMA ALLY

LANXESS plans to sell remaining stake in joint venture ARLANXEO to Saudi Aramco The joint venture is valued at 3 billion euro SPECIALTY CHEMICALS group LANXESS plans to sell its remaining 50 per cent stake in ARLANXEO to its joint venture partner Saudi Aramco. The two companies, that founded ARLANXEO in 2016 as a 50:50 joint venture for synthetic rubber, signed a respective agreement.

The transaction is still subject to approval of the relevant antitrust authorities.

At the same time, information or consultation of the competent employee representative bodies will take place. The parties expect to complete the envisaged transaction by the end of 2018. The total joint venture ARLANXEO is valued at 3 billion euro. LANXESS ex-

pects to receive approximately 1.4 billion euro in cash after deducting debt and other financial liabilities for its 50 per cent share.

LANXESS plans to use the proceeds to strengthen its financial basis and reduce net financial debt.

Originally, LANXESS and Saudi Aramco agreed on a lock-up period until 2021 for both partners. “With the envisaged transaction we would complete another important milestone of our strategic transformation earlier than originally planned. This should allow us to even better focus on our position as a leading player in mid-sized speciality chemicals markets,” said Matthias Zachert,

Chairman, Board of Management. “At the same time, we increase the resilience of our business, strengthen our financial basis and gain additional strategic flexibility for further growth.“ Back in 2016, the transfer of the business with synthetic rubber into the joint venture ARLANXEO was the foundation for LANXESS’ strategic realignment. Since then LANXESS has been focussing on growth in midsized speciality chemicals markets and made various acquisitions in this area – with the takeover of the U.S. chemical company Chemtura in 2017 as the biggest one.

THREE RATING AGENCIES UPGRADE LANXESS Three rating agencies Standard & Poor’s (S&P Global), Scope Ratings and Moody’s have upgraded the credit rating of specialty chemicals company LANXESS by one notch each.

They are now publishing new reports after LANXESS announced its plan to sell its stake in ARLANXEO. In these reports, the agencies especially highlight the company’s strengthened business profile, reduced volatility and improved financial situation.

“With their upgrades, the rating agencies are recognizing our transformation into a more profitable, more stable and more widely diversified specialty chemicals company,”said LANXESS CFO Michael Pontzen.

The European rating agency Scope Ratings raised its rating for LANXESS from “BBB”to “BBB+”today (Wednesday,August 15) – with a stable outlook. Last Thursday (August 9), S&P Global had already upgraded the specialty chemicals company’s credit rating by one notch from ‘BBB-’to ‘BBB.’The outlook likewise remains stable. On Friday (August 10), Moody’s followed suit and now rates LANXESS at ‘Baa2.’

Previously, its rating was ‘Baa3.’ Moody’s also gives a stable outlook.

EP News Bureau

EP News Bureau

Pall Corporation, Celltheon enter into partnership for biotherapeutics development This is a part of Pall’s strategic approach to forming key partnerships that help enable better, safer and faster biologic production PALL CORPORATION, a company that specialises in filtration, separation and purification, has formed a strategic partnership with Celltheon Corporation, an experienced cell line and expression technology platform development company.

This partnership aligns Pall Biotech equipment and consumables with the Celltheon SMARTTM Expression Platform to deliver integrated manufacturing solutions for customers developing biotherapeutics. It is part of Pall’s strategic approach

to forming key partnerships that help enable better, safer and faster biologic production.

“The Pall Biotech portfolio was built to support drug manufacturers at all stages of biotherapeutic molecule development and processes to improve biologic production, and ultimately, global health,” said Mario Philips, VP & General Manager, Pall Biotech.

“Pall’s strategic partnerships, such as this one with Celltheon, aim to overcome manufacturing challenges with efficient, integrated and cost-ef-

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Celltheon customers will have access to various Pall Biotech upstream and downstream processing technologies

fective total solutions,” he adds.

“The Celltheon SMARTTM Expression Platform is an offthe-shelf, fully validated mammalian cell platform used to develop biologics and it is well complemented by the Pall Biotech line of equipment and services,” said Amita Goel, CEO, founder and chairman, Celltheon.

“With the complementary Celltheon and Pall technologies, we can provide an integrated end-to-end solution for research and bioproduction that is cost effective and time effi-

cient. This partnership with Pall Corporation is in line with Celltheon’s mission to expedite drug development and provide solutions for unmet needs in bioprocessing,” she further comments.

Through the agreement, Celltheon customers will have immediate access to various Pall Biotech upstream and downstream processing technologies, including bioreactors, mixing and storage, downstream technologies, and consumables.

EP News Bureau

EXPRESS PHARMA

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PHARMA ALLY

Roquette appoints Rohit Markan as Managing Director for India Markan joined Roquette in 2016 and has an extensive business experience, ranging from marketing to sales to finance, strategy and business development ROQUETTE, A global leader in plant-based ingredients for food, nutrition and health markets, has announced the appointment of Rohit Markan as Managing Director for India, effective September 1, 2018. He succeeds Marc Dilly, who will be moving to a new role inside the Group.

Roquette has developed a growing presence in India since 2006. As one of the largest producers of food ingredients and pharma excipients in India, Roquette works with more than 2,000 local customers, who are supported by three manufacturing facilities in Pantnagar, Gokak and Viramgam.

The company also counts on a Customer Technical Services (CTS) centre, based in Mumbai, which has been establishing close collaborations and

supporting the Group’s customers thanks to a broad expertise in a comprehensive range of application segments that include food and specialised nutrition.

Markan’s appointment is a strong affirmation of Roquette’s commitment towards its talent development plans and its growth ambitions in India. Markan joined Roquette in 2016 and has an extensive business experience, ranging from marketing to sales to finance, strategy and business development.

Prior to joining Roquette, he worked for Dow Corning for close to 14 years in various roles that ranged from country, to regional and global responsibilities. Markan holds a bachelor’s Degree in Engineering with a major in Production and an MBA in Marketing. He also

completed executive programmes at the University of Michigan’s Stephen M Ross School of Business and the Northwestern University – Kellog School of Management.

This decision is in line with the Group’s strategy to be closer to its customers locally and meet India’s and Asia’s strong and growing demand for tailored nutrition products.

India is set to be the world’s most populous country by

2024. Its burgeoning middle class and their distinct tastes and requirements underpin Roquette’s decision to continue growing its presence in the area. Moreover, the recent announcement in July 2018 of an agreement to acquire Sethness Products Co, the worldwide leader in the production of caramel colour, who has a strong footprint in India, opens new development opportunities for Roquette. The recent move of the India headquarters to Mumbai is also a strategic decision to allow Roquette to better serve its customers around the country – ready to bring its global innovation and tailored-solutions to Indian consumers.

On the occasion of this announcement, Jean-Marc Gilson, CEO, Roquette, said, “We are particularly pleased

with the appointment of Markan as India Managing Director. India is a key market for the Roquette Group and an important contributor to our expansion in Asia. Markan brings a vast international experience and market knowledge which will help us accelerate our development and achieve new milestones. He will continue building a strong and sustainable business in India, a path successfully initiated by Marc Dilly, his predecessor.

Working closely with our partners and customers, Markan will lead the team to tailor our solutions to the distinct preferences, health requirements and cultural needs of Indian consumers.” Roquette employs more than 1,400 people in the country, with 150 based in its headquarters in Mumbai.

EP News Bureau

B&R joins Huawei's OPC UATSN testbed Huawei's testbed will feature an OPC UA TSN network simulating all aspects of smart factory communication – from individual sensors to the ERP system and on into the cloud B&R HAS joined the OPC-UATSN testbed of Chinese network equipment vendor Huawei. The Austrian automation specialist is now participating in all three of the world's most significant platforms for practical testing of the new communication technology.

The two other testbeds are those organised by the Industrial Internet Consortium (IIC) in the USA and Labs Network Industrie 4.0 (LNI) in Europe.

“Huawei's testbed gives us the opportunity to advance the standardisation of OPC UA TSN in Asia,” explained Stefan Schönegger, Marketing Manager, B&R, during the presentation of the testbed at the

34 EXPRESS PHARMA September 16-30, 2018

Hannover Messe. “In doing so, we’re making another important contribution towards a globally harmonised industrial communication.”

Huawei’s testbed will feature an OPC UA TSN network simulating all aspects of smart factory communication – from individual sensors to the ERP system and on into the cloud.

Data will be transmitted exclusively via OPC UA TSN – regardless of whether it is realtime motion control data or aggregated performance metrics for executive management.

There is no need for communication interfaces of any kind.

EP News Bureau

PHARMA ALLY PRODUCTS

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 be 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

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The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment

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, Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website : www.geapl.co.in

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September 16-30, 2018

PHARMA ALLY

Atlas Copco launches ZR 90-160 VSD+ air compressor with up to 35 per cent less energy consumption THE LATEST oil-free rotary screw air compressor from Atlas Copco, the ZR 90-160 VSD+, delivers up to 35 per cent energy savings for a fast return on investment. The new ZR is available with or without integrated dryer. Ideal for applications in the food & beverage, electronics, automotive, textile and pharmaceutical industries, the water-cooled ZR 90-160 VSD+ is equipped with two high-efficiency permanent magnet motors, state-of-theart compressor elements, a new cooler design and an improved monitoring system.

This plug-and-play compressor is housed in a compact, soundproof enclosure. It’s the latest air compressor in Atlas Copco’s smart AIR solutions portfolio.

The drive design of the ZR 90-160 VSD+ incorporates Atlas Copco’s most sophisticated Variable Speed Drive (VSD)

technology: NEOS drives combined with permanent magnet motors. The dual motor concept with a smart control algorithm allows both elements to be run at different speeds, which optimises efficiency.

All components in the compressor element, such as the rotor profiles, smart inlet (patent pending) and rotor coating, have been redesigned for maximum efficiency and

durability. The design and sealing of the venting chamber ensure physical separation between the oil and air circuits, eliminating any possibility of oil entering the compressed air chamber and thus guaranteeing Class 0 oil-free air.

The redesigned cooler incorporates a highly efficient water separator. Parallel water flow optimises cooling of the motor, element and the cooler

itself. Enlarged stainless steel surface coolers improve cooling efficiency and ensure top performance over a long lifetime.

The NEOS drive communicates directly with the new, user-friendly Elektronikon Mk5 Touch Controller to optimize system pressure and maximise energy efficiency.

Mk5 Touch includes warning indications, maintenance scheduling and online visualisation of the machine’s condition. The data monitoring program SMARTLINK is integrated as standard. This remote monitoring system provides analysis of the whole compressed air system on how you can reduce energy cost and plan your preventive maintenance.

The full feature version is available with integrated MDG rotary drum dryer, providing a

stable and guaranteed Pressure Dew Point of -40°C/-40°F at almost zero energy cost.

The ZR 90-160 VSD+ works together with the Atlas Copco’s new Optimizer 4.0 central controller. It enables a compressed air system to be optimised through selection of the most efficient combination of air compressors while assuring supply of required pressure and having balanced running hours. Air dryers can also be monitored through Optimizer 4.0. With the highly intuitive user interface, the end-user can view the performance and energy consumption of each machine as well as of the whole system. Optimizer 4.0 can also be monitored through a customer’s PC. Contact details 1800 200 0030 Info.compressor@in.atlascopco.com

B&R launches mapp Report software component THE MAPP Report software component can be used to automatically generate PDF reports based on any machine data. The data, layout and design of the reports can be customised. The user can freely define the language and units used. mapp Report collects all statistical machine data as well as information from other mapp components and presents it in the form of PDF reports. The content and layout can be customised as desired.

The design options offered by mapp Report make it possible to customise reports for the needs different users, such as service technicians and management. Graphical elements such as images and tables can also be included in the reports.

To protect against unauthorised access, it is possible to encrypt the files with a password.

36 EXPRESS PHARMA September 16-30, 2018

The reports can be sent automatically via e-mail at a defined time or triggered by a specific event

The reports can be sent automatically via e-mail at a defined time or triggered by a

specific event. In addition, reports can be saved to external storage media such as a USB

flash drive or sent directly from the machine to network printers.

Contact details B&R Industrial Automation 8, Tara Heights, MumbaiPune Road Wakdewadi Pune 411 003, India T +91 20 414 78 – 999 F +91 20 414 78 – 998 E www.br-automation.com

PHARMA ALLY

NewVideojet continuous Inkjet Printer drives improved performance for everyday operation THE NEW Videojet 1580 continuous inkjet (CIJ) printer helps to deliver effortless marking and coding experience with increased uptime and reduced tota With over 40 years of expertise in the continuous inkjet coding market, Videojet has launched new Videojet 1580 CIJ printer. Designed with a focus on effortless marking and coding experience, the Videojet 1580 delivers lasting uptime during everyday operation, while minimising operator errors and reducing total cost of ownership (TCO).

Manufacturers can focus on their primary tasks of running the production line, knowing that the Videojet 1580 will continue to put high quality codes on their products with minimal operator intervention. The new Videojet 1580 is enabled with Videojet OPTIMiZE software that analyses printer performance, operator behaviour and environmental parameters to help interactively guide operators on how to correct suboptimal printer usage that could lead to unplanned downtime and adversely impact line productivity or increase total cost of ownership. Operators are assisted in their printer interactions with embedded guided “how to” videos.

In many production environments, line downtime is often caused by operator errors, rather than machine malfunctions. The Videojet SIMPLICiTY user interface is designed to greatly reduce operator printer interactions, helping to eliminate potential user errors through an easy to operate, tablet-inspired 10-inch touchscreen display.

This advanced Code Assurance capability offers intelligent message creation functionality, and customisable interfaces with built-in wizards that allow operators to only see the options they need, reducing the opportunity for operator-induced errors.

The Videojet 1580 relies on a combination of technologies that

further increase uptime. A builtin make-up reserve tank enables the printer to run for a minimum eight hours after the cartridge is empty, providing operators with ample notice to replace it during

normal line changeovers or shutdowns. Field-proven perforated nozzle with optional Videojet CleanFlow technology, requires less frequent cleaning and delivers longer runs and consistent

print performance. Operators can also quickly perform routine maintenance with easy-tochange Videojet SmartCell colour-coded printer components, that are engineered for

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predictable replacement intervals to align with normal line shutdowns and no additional production downtime.

With optional VideojetConnect Remote Service, the Videojet 1580 offers on-board remote service capabilities at the touch of a button. Operators can gain instant access to the world’s largest network of CIJ experts, connecting the Videojet technician directly to the production line for immediate assistance.

This virtual access can help manufacturers to recover quicker, and deliver increased uptime, while minimising the need for in-house maintenance.

Engineered to continuously analyse its own health, the Videojet 1580 CIJ printer gives customers the peace of mind of minimal unplanned line downtime, as well as the ability to monitor its own vital signs to enhance everyday printer performance and reduce ongoing costs. The Videojet 1580 CIJ printer – vital signs for everyday improvement.

Contact details Xing Zhi Gu ABI, a Finn Partners Company 60 Paya Lebar Road #07-03, Paya Lebar Square Singapore, Singapore 409051 +65 6816 2813 xingzhi.gu@finnpartners.com

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PHARMA ALLY

Measuring consistency with ROTAVISC from IKA AFTER IT'S been produced, stirred and shaken, the viscosity of a sample can now be measured with the new ROTAVISC series from IKA. This parameter indicates the fluidity of a substance and is important for quality control in all manufacturing processes and even early on in the application in the research laboratory. ROTAVISC is the most functional viscometer in its class.

Four new models for different viscosity ranges are part of the new product series. They deliver extremely precise measurements under different conditions, so that chemical substances, cosmetic products, paints or foodstuffs actually achieve the desired consistency and reliably maintain them, even at different temperatures.

The new ROTAVISC series viscometers are characterised by their infinite viscosity measurement ability. At the same

The ROTAVISC series viscometers are characterised by their infinite viscosity measurement ability time they are very easy to handle. In addition, device control and the documentation of the measurement process are possible using special software. ROTAVISC offers users the popular IKA laboratory equipment structure and can be tested in the IKA Application Center.

IKA is one of the leading global manufacturers of labora-

tory equipment, analysis and process technology for science and industry. With more than 900 employees, the company strives to deliver the best technology, to help make the work of its customers even more successful. This is supported by close collaboration with globallyrenowned universities and scientists. Besides Germany, IKA is today represented by its own subsidiaries in the US, China, Malaysia, Japan, India, Brazil, Korea, Vietnam, Great Britain and Poland.

Contact details IKA India Sonja Steiert Project Manager â&#x20AC;&#x201C; Sales & Marketing 814/475, Survey No.129/1 Mysuru Road, Kengeri, Bengaluru 560060, Karnataka Tel: +91 (0)80 26253 900 Email: info@ika.in

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 1st Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

Board line: 0120-6651500.

Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com

CHENNAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 044- 42285522 Fax: 044- 28543035 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com

BANGALORE Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Fax: 080- 22231925 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com

HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad â&#x20AC;&#x201C; 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936, Fax: 040 23418675 Email Id: e.mujahid@expressindia.com

KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com

AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015, Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

38 EXPRESS PHARMA September 16-30, 2018

PHARMA ALLY VALUE ADD

The era of individualisation has only just begun For today’s generation of digital natives,the ability to personalise the products they buy is increasingly expected as a given.To keep pace,the makers of these products need highly flexible manufacturing systems that are at the same time efficient and profitable.This introduces a whole new set of demands on plant infrastructure.An insight by Carmen Klingler-Deiseroth,a freelance journalist THE VARIETY of options available for customising massproduced products continues to grow. It’s no longer limited to the usual suspects like breakfast cereals, cars and photo books. Particularly among the younger generation of digital natives, there is a growing desire to fine-tune every online purchase to match their individual tastes and preferences.

“The era of individualisation has only just begun,” declares Robert Kickinger, Mechatronic Technologies Manager, B&R. Profitable production in batches of one Batch-size-one production is nothing new, really. In fact, it’s standard practice in many craft businesses.

“What is new, however, is the idea of making customised products under mass-production conditions,” asserts Kickinger. So far, this has proven difficult to implement in a way that is economically viable. That’s because any increase in system flexibility is usually accompanied by a reduction in overall equipment effectiveness (OEE). “When that happens, individualisation is no longer profitable.”

The goal of mass customisation is therefore to keep the three factors of OEE – availability, performance and quality – at a level consistent with what can be achieved in mass production. In addition, manufacturers seek to maximise their return on investment (ROI) and to minimise their time to market (TTM) for new and improved products. “This is the only way to make mass customisation viable from an economic perspective.”

Up to now, developing flexible manufacturing systems has been a tedious process. “In many cases, you don’t see the problems until the system is ac-

tually up and running,” explains the mechatronics expert. At that point, fundamental\ changes to the machine design can extend the time to market by months. "That can be very costly." If the system as a whole or individual components can be simulated and tested in advance, the time to market can often be reduced dramatically.

Fast changeover Once the system is in opera-

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tion, availability becomes a decisive factor and changeover times play an important role.

“The kind of individualised mass production we'll see in the future will be characterised by near real-time processing of online orders,” explains Kickinger. By defining the features of the products they order online – from cars to printed products – today's customers have already assumed a highly-automated role in the

production process. "This will soon be the standard approach for a much broader range of products," he maintains. To ensure system availability and profitability, changeover times will need to be kept to a minimum or even eliminated entirely.

Yet, it's not just the products themselves that are becoming increasingly customised; the same holds true for how they are packaged. A

bottling line that produces three different beverages, for example, should also be able to combine them into any conceivable six-pack arrangement. “That's simply not possible on a conventional line,” says Kickinger. The constant changeovers would throttle productivity. “What’s needed is a solution that allows flexible integration of product flows in real time and at full speed.”

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September 16-30, 2018

PHARMA ALLY Real-time rejection To ensure sustained high quality, lines must be able to react to faults and defects in real time – without compromising the production process. “Defective products need to be rejected on the spot, while maintaining full production speed,” says Kickinger. If a defective item is not sorted out immediately following quality inspection and is instead permitted to continue down the line, it will eventually become necessary to scrap an entire package full of products.

It's not only products that can be defective, however. If one valve in a bottling line stops working, for instance, the automation system should react intelligently by no longer sending bottles to that station, while the process as a whole continues uninterrupted.

Kickinger notes that there have traditionally been two options in such a scenario: “Either I let the process keep running and scrap all the products affected by the faulty valve, or I stop production altogether.” From an economic perspective, neither alternative is particularly attractive.

Scalability and ROI In most cases, a conventional manufacturing system doesn't scale easily. To increase output, it’s necessary to either add a second line or replace the existing line with a larger one.

These options require considerable investment and eat up valuable floor space. “But, it doesn’t have to be that way,” promises Kickinger.

In a rigidly-timed process, the slowest station determines the maximum output rate. To increase output, the automation solution needs to enable more dynamic timing of processing cycles. If you’re able to perform those slower processing steps at multiple stations in parallel, you can multiply productivity without a proportional increase in the machine footprint. Such an approach hinges on the ability to split the product flow and then merge it back together farther down the line.

Competitive advantages If the line also allows you to add

40 EXPRESS PHARMA September 16-30, 2018

and remove stations on site, that opens up additional possibilities to adjust capacity to changing demand. “Manufacturing technology that adapts to your production requirements: that’s ROI you can take to the bank,” says Kickinger.

ROI, OEE and TTM are the main economic factors underpinning all manufacturing operations. In this context, both the builders and operators of machinery and plants must rise to the challenge of increasing production flexibility. “Fail to take this seriously and you will find yourself at a competitive disadvantage,” warns Kickinger. Mass-customised products have been shown to achieve higher margins than their conventional counterparts. Successful implementation, however, stands or falls with key advancements in plant infrastructure.

The future of individualisation At the 2017 SPS IPC Drives, B&R will be presenting a new product that will simplify mass customisation dramatically.

The product will be unveiled at the B&R booth (Hall 7, Booth 206) on November 28 at 9:30 AM. The event will be broadcast live around the world on YouTube.

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For almost 40 years, Domino has been a leading global producer of innovative printing, coding and marking solutions for the Pharmaceutical and healthcare industries.This equates to extensive experience in serialization support.

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PHARMA LIFE NEWS

Lupin’s ‘Learn and Earn’programme to train 1,000 graduates by 2020 The company organises convocation for graduates in Panaji

By Sanjiv Das

Lupin has been able to help around 560 graduates with 181 students passing out this year and plans to expand this programme to other facilities

L

upin recently organised a convocation ceremony for its graduates, who passed out through the company’s ‘Learn and Earn’ initiative. The initiative, which was conceptualised in 2010 due to acute shortage of skilled manpower, recognised the third batch of graduates at a recently held event in Margao, Goa. The curriculum has been designed in concert with Yashwantrao Chavan Maharashtra Open University. It confers the graduates with a Bachelor’s Degree in pharmaceutical Chemistry education BVOC in manufacturing technology, after completion of the three year programme. The third batch which registered in 2015 were recognised at the graduation ceremony in Panaji, Goa. Yashwant Mahadik, President, Global Human Resources, Lupin, said, “This heart-warming programme

by Lupin, which not only makes a difference to the society, is very well aligned to the National Skill Development Mission of the government.

We will try to do this at places where Lupin has a manufacturing facility.”

Mahadik further said, “Students while studying also get an opportunity to learn and we provide the students with a stipend, which encourages an entire family to get their children to go in for education. We also provide the students with hostel accommodation, coaching and support while preparing them for the programme. We want this

56 EXPRESS PHARMA September 16-30, 2018

(L-R) C Srinivasulu, Sr Vice President-Human Resources, Lupin, Yashwant Mahadik, President, Global Human Resources, Lupin

programme to reach newer heights and spread this programme to other facilities as well.”

Lupin plans to graduate 1000 students by the year 2020 and is likely to spend ` 20 crores which will bridge the manpower requirement.

According to C Srinivasulu, Sr Vice President-Human Resources, Lupin, since 2011, Lupin has been able to help around 560 graduates with 181 students passing out this year.

The programme is aimed at 12 th class science students with a minimum 50 per cent marks, but are facing financial constraints in pursuing further studies and careers in the pharma industry. The Learn and Earn initiative programme has been initiated at facilities in Goa, Tarapur and Aurangabad in Maharashtra, Indore in Madhya Pradesh and Sikkim. sanjiv.das@expressindia.com

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