Express Pharma (Vol.13, No.7) February 1-15, 2018

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CONTENTS Vol.13 No.7 February 1-15, 2018 Chairman of the Board Viveck Goenka

Going glocal: Is it the way forward? As India Pharma Inc strives to enter new, previously unexplored markets and battles unprecedented challenges, ‘Think Global, Act Local’ approach might be one of the strategies to derive a competitive advantage | Pg 26

Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

P16: INTERVIEW

National Design Editor

‘We will look to focus on India as a part of our growth and market expansion strategy’

Bivash Barua Asst. Art Director Pravin Temble

Sanjaya Mariwali, MD, OmniActive Health Technologies

Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

MANAGEMENT

Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer) Photo Editor Sandeep Patil

Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

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LEGAL ASPECTS TO MAINTAIN THE QUALITY STANDARD OF DRUGS

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HEALTHCARE SABHA TO BE HELD IN PUNE FROM MARCH 8-10, 2018 ASPA TO CONDUCT SUMMIT ON ANTICOUNTERFEITING AND BRAND PROTECTION PHARMACONNECT 2018 HELD IN NEW DELHI IDMA CELEBRATES 56TH ANNUAL DAY IN MUMBAI ANTI-COUNTERFEITING AND BRAND PROTECTION SUMMIT 2018 HELD IN MUMBAI

PHARMA ALLY

RESEARCH

Senior Artist Rakesh Sharma

MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

MARKET

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NOVARTIS’ PROMACTA RECEIVES FDA BREAKTHROUGH DESIGNATION FOR NEW INDICATION

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ADHD DRUG TIED TO HEART DEFECTS IN BABIES

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ROMACO APPOINTS JÖRG PIEPER AS CEO

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COPLEY SCIENTIFIC LAUNCHES BAC 2100 BREATH ACTUATION CONTROLLER

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GANDHI AUTOMATIONS’ DOCK LEVELLERS ENSURE EFFICIENT UNLOADING OF GOODS

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ANAYTICAL DETECTION IN HP-TLC

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

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

Countering India Pharma Inc’ Achilles heel

I

ndia’s drug regulator, the Drug Controller General India (DCGI), should be cheered by a recent report from India Ratings and Research (Ind-Ra), that seems to suggest that India Pharma Inc is in the process of reducing its dependence on APIs from China. The Ind-Ra comment dated January 30 headlines that the DCGI's recent ban on a few Chinese API makers would not impact the credit profile of Indian pharma formulators under its coverage. The note specifies that the banned Chinese API makers are not approved suppliers to the large (revenue above ` 10 billion at end-FY17) and mid-sized formulators (` 2.5 billion-10 billion) rated by the agency. Channel checks also revealed that neither are they suppliers to their indigenous contract manufacturers. This analysis should give policy makers in India's Department of Pharmaceuticals some satisfaction that industry has heeded warnings to reduce dependence on Chinese APIs. The apprehensions were on two fronts: quality and national security concerns. The DCGI's recent ban came due to significant deviations in regulatory compliance set by Central Drugs Standard Control Organisation (CDSCO), leading to concerns about the quality of the APIs from these six to eight companies, after inspection of several API manufacturing facilities in China. China and India are the leading sources of APIs and competition for market share is only going to get more fierce. Indian pharma companies have to realise that backward integration into cleaner APIs might be more capital intensive today but could help them edge out Chinese APIs in lucrative markets like Japan, which are evolving towards generics and biosimilars, while opening up to imports. A New Year report from CPhI forecasts that rising generic usage is the biggest opportunity for domestic manufacturers (60 per cent) with Indian manufacturers bagging a relatively high vote of 24 per cent of respondents. Here, the US and European manufacturers were chosen by less than 10 per cent of respondents as price will remain the primary factor when choosing imported generics medicines. Japanese companies were much more open to sourcing foreign APIs (as opposed to finished products); from China (60 per cent), India (48 per cent) and Europe (67 per cent: excluding Italy). This high share should convince large Indian pharma companies as well as API contract manufacturers that investments in APIs should be planned not keeping both domestic demand as well as exports in mind. While the anticipated disruption in medicines

APIs have been the Achilles' heel of Indian pharma companies but backward integration into cleaner APIs could help them edge out Chinese APIs in lucrative markets like Japan

supplies due to the ban on these six to eight Chinese API makers would hopefully be minimal, the larger picture unfortunately remains unchanged. Larger pharma companies have reduced Chinese API imports from 20-25 per cent of total APIs in FY12 to 10 -15 per cent in FY17, but their smaller peers have been unable to follow suit. The Ind-Ra report points to data from the Directorate General of Commercial Intelligence and Statistics (DGCI&S), which shows that value of Indian imports of bulk drugs and intermediates dropped from ` 212.3 billion in FY16 to ` 183.7 billion in FY17 but volumes increased from 269.2 million kgs in FY16 to 278.8 million kgs in FY17. China's share in India's imports of bulk drugs and intermediates by value increased from 65.3 per cent in FY16 to 66.7 per cent in FY17, with a corresponding increase in volume terms from 58.8 per cent in FY16 to 60.7 per cent in FY17. Larger pharma companies exporting formulations to regulated markets need to use APIs from primary and secondary sources pre approved by the regulatory agencies of the destination country (like the United States Food and Drug Association, European Directorate for the quality of medicines and UK Medicines and Healthcare Products Regulatory Agency). APIs from Chinese manufacturers are generally preferred for commoditised formulations while high value critical formulations are manufactured using an indigenous API source, according to the Ind-Ra comment. Small and mid sized pharma manufacturers should aim to capture a share of markets like Japan, which are just opening to generics and invest in a bigger way in backward integration not just on APIs but key starting ingredients as well. APIs have been the Achilles’ heel of Indian pharma companies and have been responsible for holding back the growth of the sector. But this weakness can be overcome, with sustained efforts. For instance, over 60 per cent of respondents to the CPhI report on Japan believe brand loyalty hinders uptake, in particular, for Indian-made products. Despite this, the international market had a strong view that Indian companies (47 per cent) had the biggest opportunities for generics growth. India was second to domestic manufacturers (52 per cent), while confidence in European (35 per cent) and US manufacturers (25 per cent) was some way behind. Of course, this preference has a lot to do with the low cost of India’s generics compared to the other countries mentioned. Thus a long-term view to building the brand of Made in India APIs will go a long way towards sustainable success. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

‘We will look to focus on India as a part of our growth and market expansion strategy’ Mumbai-based OmniActive Health Technologies is strengthening its presence in the Indian market. The company is working on developing products and technologies which will not only serve current markets and customers but also expand to new geographies and consumer bases. Sanjaya Mariwali, MD, OmniActive Health Technologies talks about the plans in detail with Usha Sharma

Tell us about the ongoing activities of OmniActive Health Technologies in India and abroad. What makes your company unique from other nutra players? With offices and facilities located globally in India, the US, Canada and Europe, OmniActive is a global player focused on understanding the unique challenges and market needs of our partners in different geographies and their respective regulatory landscapes. The company’s manufacturing operations are located at multiple sites in India and are cGMP and HACCP system compliant and US FDA inspected. As an innovative player, focused on science and research, OmniActive is committed to innovating products and technologies that can not only impact our lives today but can also provide solutions to the address the emerging challenges of tomorrow. We at OmniActive, leverage international R&D strengths to deploy an array of state-ofthe-art manufacturing technologies in extraction, purification, isolation and delivery of nutritional actives. OmniActive has always maintained visibility and sustainability in the entire supply chain, and extend this control over all stages of the manufacturing process. To ensure

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traceability and, transparency while fostering sustainable practices, OmniActive produces its Lutemax range of lutein ingredients under a vertically integrated supply chain. Similarly, the paprika line is also vertically integrated for zeaxanthin. How large is the Indian nutra market? By what percentage is it growing and where does OmniActive Health Technologies stand? The nutra market in India is in a fairly nascent growth stage. But, all current market trends and research show that there is a tremendous potential for growth within the Indian nutraceuticals market. Currently, the market is expected to grow at 8-10 per cent upwards annually. Focused awareness building and research efforts by the industry is helping innovate and formulate products specifically for the Indian consumer and their identified needs. Our focus is currently export based but with the growth in the India nutra industry, we will look to focus on India as a part of our growth and market expansion strategy going forward. Ayurveda is one of the oldest traditional systems of medicine (TSMs) which is also accepted and recognised worldwide,

Innovation in products and technologies will be a focus to expand market and segments of interest.We will focus on organic and inorganic growth to maintain our leadership position in the industry

however it has limited expertise in this arena, tell us the reason behind it? Ayurveda is definitely one of the oldest and accepted traditional systems of medicine globally. To help the benefits of Ayurveda reach a wider base, the focus needs to be on applying modern technology and research to innovate products for today’s consumers. This is where probably the growth curve has been slower for Ayurveda, however the trends are very encouraging. With a more aware consumer base who is demanding modern solutions using traditional knowledge, manufacturers are also re-discovering the benefits and science that Ayurveda offers. Through applying innovative technologies and delivery formats they are able to formulate products using this traditional knowledge. Give us an information about your products and their USPs. Were clinical trials conducted on these products and where? OmniActive develops IP-protected, science-backed branded ingredients from natural sources using cutting edge technologies. Core products in our portfolio include carotenoids, plant extracts and speciality functional natural ingredients. We offer the most comprehensive line of

macular carotenoids through our Lutemax brand of free lutein, Lutein Esters and Lutemax 2020 and OmniXan range of Zeaxanthin brands. Other key innovative ingredients include Capsimax, a concentrated natural capsicum in a controlled-release beadlet; CurcuWin, our highly bioavailable turmeric powder product; Gingever Ginger product and OmniLean Salacia product. Substantiation through clinical studies is a key part of our R&D initiatives. Clinical studies provide us unique science-backed claims to expand consumer offerings across our range of branded ingredients. How many scientists are associated with your company? Which in-house technologies have you developed? With research at the core of what we do, we have a large and accomplished team of around 45 scientists working across our three R&D locations. This includes expertise in key areas like formulation and analytical science and food technologists along with dedicated teams working on our clinical and regulatory programmes. Our innovative technologies include the OmniBead Beadlet Technology and UltraSOL

Nutrient Delivery System that help solve some of the greatest challenges that supplement manufacturers face. OmniBead Beadlet Technology is a ‘smart’ coating system that provides a solution where organoleptic characteristics or stability of nutrients present challenges, allowing them to be incorporated into a larger variety of applications and finished products. Presently, you have global offices in the US, Canada and Europe. Do you plan to venture into new markets and segments? As a growing company, in a very interesting industry, we are definitely looking at expanding into new markets and health segments. Our R&D and innovation

initiatives are continuously working on developing products and technologies which help us not only serve our current markets and customers but also expand to new geographies and consumer bases. You have recently acquired Bengaluru-based health and nutrition active natural ingredients firm Indfrag. Tell us more about the acquisition? In January 2017, OmniActive had acquired Bangalorebased leading health and nutrition active natural ingredients player Indfrag Ltd (Indfrag). This acquisition is in line with OmniActive’s programme to create global partnerships which help expand the portfolio of high quality authenticated

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ingredients for the dietary supplement and functional food industries. Indfrag holds a leadership position in standardised plant extracts and with their strong footprint at the source, they have developed a large library of botanicals. This will help provide a strong foundation for launching products that complement OmniActive’s innovation platform in meeting emerging industry and consumer needs. How are you going to utilise the funds received from Everstone Group? As a strategy to grow inorganically, we had raised funds from the Everstone Group. The funds were utilised as a part of our acquisition of Indfrag Ltd earlier this year.

Frost and Sullivan has recently recognised OmniActive Health Technologies for 2017 North American Product Leadership. Tell us more about the recognition. Based on its recent analysis of the eye health ingredient market, Frost & Sullivan recognised OmniActive Health Technologies with the 2017 North American Product Leadership Award. It is an honour to receive this award for our unique Lutemax 2020 product. OmniActive’s strong R&D culture, vertically integrated manufacturing, and quality control systems (cGMP and HACCP systems) in all of its FDA CFR110 cGMP audited facilities, has positioned the company as a market leader with Lutemax 2020. This is a

unique eye health ingredient that has demonstrated efficacy and safety through extensive clinical trials and university partnerships and this has been reaffirmed by this recognition provided to us. Tell us about the corporate plans of your company and how are you achieving them? OmniActive is going to focus on its growth strategy, and maintaining double digit growth figures going forward also. Innovation in products and technologies will be a focus to expand market and segments of interest. As a strategy we will focus both on organic and inorganic growth to maintain our leadership position in the industry. u.sharma@expressindia.com

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MARKET PRE EVENT

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

Healthcare Sabha held in Hyderabad and Vizag provided an excellent platform for researchers, policy makers, healthcare practitioners, public health advocates to share and exchange evidence drawn from research and experiences in health development programmes in India. Over the past two editions, public health experts came together to share their insights

on public health policy and its implementation. The first edition was ”Universal Access to Equitable, Affordable and Quality Healthcare Services to

All’ while the second edition focused on “Co-creating a Manifesto for a Healthy India.” As India’s public health ecosystem continues to evolve, the third edition of Healthcare Sabha invites public health leaders to work towards formulating a change strategy, built on three principles: Prioritise, Plan and Practise. The central theme of the two day event aims to explore and

debate how India can bring in a multidisciplinary and holistic approach across the spectrum of public health. As in past editions the deliberations of the speakers, panelists and delegates will be compiled into an OUTCOMES REPORT . For more details check: http://healthcaresabha.financialexpress.com/ EP News Bureau

UBM India to organise Pharma Project Management Conference in Mumbai The summit is expected to witness a large gathering of industry stalwarts on the rostrum to enhance skills and techniques on project management CPHI CONFERENCES, a division of UBM India which hosts a number of successful pharmaceutical conferences has announce the 6th Annual ‘Pharma Project Management Conference’ which is scheduled for February 22 – 23, 2018 in Mumbai. Driving a product to the market safely, quickly, and cheaply is the best way for a pharma firm to be successful. Pharma companies encounter enormous challenges during the long product-development process. The identification of risks at the right stage and an effective mitigation plan are key factors for success, both financially and technically. The complex drugdevelopment process from lab

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to launch includes management of several business processes such as technical development using quality by design, regulatory strategy, clinical studies, and supply chain. The inherent uncertainties during the evolution of any of these processes require constant change in plans. If the risks associated with the uncertainties are not managed in a timely and effective manner, the complexity of the situation increases dramatically and it subsequently becomes cost prohibitive for the developing industries to move forward. Although project management has been known to drive industrial success through effective risk management in other industries, it has only been introduced to the

Project management was introduced in the pharma industry in the last decade and is continuously evolving pharma industry in the last decade and is continuously evolving. The analysis of critical factors such as the roles of project managers and stakeholders,

team communication and key business processes helps to identify strategies for addressing these challenges. In-depth understanding of these factors can help put pharma companies on the road to success in launching a quality product that can improve quality of life. In this limelight, CPhI India is bringing in the 6th edition of ‘Pharma Project Management’ conference. The summit is expected to witness a large gathering of industry stalwarts on the rostrum to enhance skills and techniques on project management.

Key topics include ◗ Overview of Pharma Project Management

◗ The Pre-Mortem: A Simple Technique To Save Any Project From Failure ◗ Project Management Methodology: Tools and Techniques ◗ Achieving Operational Excellence by Effective Project Management ◗ Project Manager: The Key Role Player in Projects ◗ Maximizing Returns Through Efficacious Resource and Financial Planning ◗ Stakeholders In Project Management ◗ CRO’s: Customer Relationship ◗ ‘Bridging the Hive: That is Significant’ - Nexus between Corporate Strategy and Portfolio Management ◗ Cross Pollination EP News Bureau

MARKET

ASPAto conduct summit on anti-counterfeiting and brand protection The second edition of Authentication Forum 2018 will be held on March 15-16, 2018 in New Delhi AUTHENTICATION Solution Providers’ Association (ASPA) has announce The Authentication Forum 2018, Leadership Summit on Anti-Counterfeiting and Brand Protection. The two-day leadership summit will be held on March 15-16, 2018 at Hotel Taj Mahal, Man Singh, New Delhi. The Authentication Forum 2018 promises to be bigger and

The event will be attended by 200 delegates and speakers from across the globe better with over 200 delegates and eminent speakers from across the globe discussing key topics such as; ◗ Understand the regulatory perspective – role of government roles to protect the interests of consumers. ◗ Understand the 5Ws of Counterfeiting: What, Who, When, Where, Why? ◗ Hear Global perspectives on the fight against counterfeiting ◗ Educate yourself on the future of anti-counterfeiting technologies – Can Blockchain and NFC play a part? ◗ Understand how to select the right Anti-counterfeiting technologies and solutions ◗ Learn from the practical examples of brand owners through their case studies ◗ Learn to devise your enforcement efforts and raids ◗ Network and interact with the Best Minds of Industry ◗ An Interactive Townhall Session (Who is going to take the lead against fighting Fakes) and much more!"

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

MARKET POST EVENTS

PharmaConnect 2018 held in New Delhi The conference provided an excellent knowledge sharing and networking platform to a gathering of over 250 professionals from the logistics and pharma industry Lakshmipriya Nair NewDelhi PHARMACONNECT 2018, a pharma logistics conference was held recently in New Delhi. The one-day conference saw major players of pharma industry, logistics industry, regulatory bodies, airline companies and cargo terminals come together with an objective to create a knowledge sharing and networking platform. Dr K Bangarurajan, Joint Drugs Controller of India and PK Gupta, Chairman, Confederation of Indian Pharmaceutical Industry (CIPI) were present as the Chief Guest and the Special Guest on the occasion. They inaugurated the conference with a lamp-lighting ceremony along with Satish Lakkaraju, CCO, Agility Logistics; Yashpal Sharma, MD, Skyways Air Service; Smiti Suri, Publisher, Surecom Media and Ajit Suri, Director, Surecom Media. Dr Rajan addressed the audience and gave an overview on CDSCO’s activities and touched upon various aspects of the industry. He also recommended meaningful collaborations with pharma associations and highlighted the potential of airways to transform pharma logistics for the better. He advised logistics service providers to engage in dialogues with manufacturers to reform the sector. He further informed that the CDSCO is constantly revising the rules and regulations of the Drugs and Cosmetics areas for improvements. Gupta elaborated on how essential it is to ensure efficacy of drugs and ensure drug safety. He also explained about the ideal storing and transportation conditions and spoke on temperature control and over methods to improve the logistics sector. The conference also had four panel discussions which touched upon various pivotal facets of

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pharma logistics and supply chain. The first panel discussion was on the role of LSPs in the growth story of Indian pharma industry. It also revolved around innovative practices, evolving strategies and methods to enhance the operation of pharma logistics. The expert panel for this discussion comprised Xavier Britto, Chairman, Indev Logistics; V Raju, VP, Avvashya, CCI; Jasmine Singh, CBRE South Asia; Babette Desfossez, First Counsellor, Customs Attache, Embassy of the Kingdom of Belgium; Bimal Jain, Independent Tax Practitioner; Vickram Srivastava, GM – GDSO, Zydus Cadila; Soumyakant Dwivedy, Head – Supply Chain, Becton Dickinson and Manas Sahoo, VP Supply Chain, Fresenius Kabi. The panelists urged the need for innovation in logistics, whether it is tracking, packaging solutions, or distribution models. They pointed out that there is a lot of opportunity to use multi

modal ways of logistics. Invest in infrastructure development to leverage opportunities, was their advice. They highlighted that even ice creams and chocolates have better supply chains than drugs. A major takeaway of the session was that anybody who can come up with innovative solutions for logistics has great business opportunities. The second panel discussion was on the importance of supply chain integrity, end to end visibility and time factor in pharma air cargo shipment. This discussion focussed on supply chain blind spots to increase safety, improve quality and enhance reliability and examined the relevance of risk identification and risk management with respect to timely delivery of pharma products. It also explored the strategies to develop India as a life science hub in coming years and emphasised on the need to improve last mile distribution through full end-toend supply chain collaboration. The panelists in this session

were Manoj Singh, Senior VP and Head – MIAL; Shankar Iyer, Head of Cargo, Africa, Middle East and India, Lufthansa Cargo; Adarsh Kumar, Cofounder and CEO, TagBox Solutions; Ryan Viegas, Head of Logistics, TEVA Pharmaceutical; Yogesh Lawania, GM – Supply Chain, Biocon. In another interesting session, experts and veterans of the pharma logistics industry deliberated on the measures to keep cold chain logistics cost in control for maintaining competitiveness of pharma products and to manage fluctuations in demand for temperature-dependent drugs. Vipan Jain, COO, DCSC; Satish Lakkaraju, CCO, Agility; Sameer Varma, Director, ColdStar Logistics; Kiran Gubba, CEO, Gubba Cold Storage; Ashwani Singh, Head – Global Procurement, Piramal Enterprise and Surendra Deodhar, Assistant VP, Reliance Life Science were the panelists for this session. They spoke on myriad issues ranging from latest innova-

tions and rising technological trends in logistics of pharma through cold chain to simulation technology and virtual cold chains. They also touched upon a crucial issue - controlling the cold chain through the last mile and the role of cloud in enabling it. The last panel discussion touched upon the importance of IoT for streamlining of pharma supply chain and cost optimisation. The panelists in this session were tackled many aspects connected to the subject including ways through which IoT has been facilitating pharma supply chain, convergence of IoT, continuous monitoring and lane aualification; role of IoT in avoiding health hazards during pharma transit and technological trends in life science logistics in India and overseas. Ramesh Mamidala, CEO, CELEBI; Sandeep Chatterjee, Senior Manager, Deloitte; Sukhwinder Singh, Senior VP, Blue Dart Express; Samir J Shah, Partner, JBS; Mahesh Trikha, Chairman, Argus Global; Amrinder Singh, Associate Director — Supply Chain, Dr Reddy’s and Gopalkrishna, Hetero Drugs. Foster McDonald, CEO, Cold BOX Express; Harsh Kumar, Cofounder, Cogoport; Srinivas Cherukupalli, Principal Research Scientist, Dupont; Gunjan Sachdeva, Senior General Manager, Panasonic and Ibrahim SIPAHI, Cargo Development Specialist, Turkish Cargo also gave engaging presentations in between panel discussions. India Air Cargo Handbook 2018 powered by CARGOCONNECT magazine was also released in the gracious presence of all guests and delegates in the conference. The conference was a good platform to learn, meet, interact and explore new growth opportunities and newer business avenues in the pharma industry. lakshmipriya.nair@expressindia.com

MARKET

IDMAcelebrates 56th Annual Day in Mumbai Association also gave Quality Excellence, Patents, Research Papers, Chief Mentor, Corporate Citizen and IDMA JB Mody Best Student Awards THE INDIAN Drug Manufactures’ Association (IDMA) recently celebrated its 56th Annual Day in Mumbai. It was attended by representatives from the Central government and state regulators as well as pharma companies. Dr GN Singh, DCG(I), Bhupender Singh, Chairman, NPPA, Dr RK Vats, Additional Secretary (Health) & DG, CGHS, Dr S Eswara Reddy, Joint Drugs Controller (India) were the Guests of Honour and Ashwini Kumar Choubey, Minister of State for Health & Family Welfare was the Chief Guest at the event. Daara Patel, Secretary General, IDMA welcomed the delegates to the event. He also touched upon and highlighted the issues faced by the industry in his welcome address. Ashwini Kumar Choubey, Minister of State for Health & Family Welfare appreciated the Indian pharma industry for their contribution towards improving the Indian healthcare system. He praised them and said that doctors in India are considered equal to god but without you (the pharma industry) doctors won’t be able to cure ailments. He also informed the audience about the improvements in the business environment of Uttar Pradesh (UP), Bihar and Jharkhand and asked the industry to consider investing in these states. Dr Singh, said that most of our labs across India are working with start-ups and inventing good products, however we need to strengthen the regulatory set-up. Foreseeing the future, he said that the government is thinking about how to get innovations. He also stressed that globally Indian pharma companies are expanding its horizons, however we need to fortify our current capabilities and competencies rather than entering into other areas. He asked the industry to withdraw FDC products voluntarily as they are not good for patients. Talking about bio-availability and bio-equivalence (BA/ BE) studies, he said

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that we want to have assured medicines for our country’s patients. He asked the industry to

come forward and show us which BA/ BE studies need to be carried out first. He further said

that the government believes patients should know the quality of medicines they are consuming.

We all have to be pro-patients and all the medicines we are producing should adhere to all

MARKET quality levels. He signed off by saying that the regulatory system in India is changing and moving towards self regulation. After his speech, Singh gave his speech. He said that before DPCO 2013 we had a cost-based policy but, now we have migrated to a marketbased policy. He said that though he is not in favour of a cost-based policy, a market-based policy is good only if it is followed in the right manner. Today there are lots of avenues for trade margins in market-based policy. He further said that in India we treat patients as customers whereas it should be seen differently. Cautioning about the future, he said that in the future price regime is going to more strict. Drawing comparisons between the Indian pharma industry and the IT industry, Singh said that like the IT industry, we too need to move up the value ladder in pharma. In India, the IT boom occurred with BPOs and now we see a lot of start-ups coming in IT, this is because they have moved up the ladder from servicing to creating innovation. Dr Vats also stressed on self regulation and said that pharma companies should be best at checking their own products’ quality even before the regulators do it. Deepnath Roy Chowdhury, National President, IDMA addressed the august gathering and informed them about the key activities initiated by the association. In his speech, he said that the Indian pharma industry, over the last few years, has come to be recognised as the proud torch bearer of India’s

abilities in providing quality affordable medicines. He said, “To emphasise that our mass production of quality and safe, affordable generic medicines have brought glory to the nation by contributing immensely to alleviate the national and global disease burden, we continue with our theme of ‘Indian Pharmaceuticals Nation’s Pride’ this year.” Stressing on the need for

indigenous APIs, he said that due to collective efforts in interactive meetings and effective recommendations to the government they have formulated seven recommendations for APIs and the idea is not to create hurdles to Chinese APIs but to give filing to Indian API manufacturers. He welcomed DCGI’s initiative of notifying licenses in

perpetuity with only renewal fees to be paid every five years. Over 2500 SLAA FDCs approved by Kokate Committee have been cleared by DCGI till date for all manufacturers by submitting the modified Form 44. FSSAI has extended implementation date of nutraceuticals’ regulations by six months to July 1, 2018 thus allowing the industry to continue with

products that have ingredients not yet approved/ unapproved. Amit Mookim, MD, South Asia, IQVIA delivered the keynote. He cautiously informed the industry and said that Indian companies who are servicing the US market need to widen their portfolio because a single portfolio has limited business opportunities. He stressed on business opportunities that exist in the emerging markets as it is going to be $211 billion market by 2022 which is growing by five per cent and Indian players have significant headroom for growth. IDMA also honoured and gave away awards on Quality Excellence, Patents, Research Papers etc. Chief Mentor Award, Corporate Citizen Awards and IDMA JB Mody Best Student Awards were some of the other awards. u.sharma@expressindia.com

Anti-counterfeiting and Brand Protection Summit 2018 held in Mumbai Organised by Inventicon, experts at the two-day event urge constant innovations and upgradation of technology to fight counterfeiting THE Anti-counterfeiting and Brand Protection Summit 2018, organised by Inventicon gave a platform to the industries to discuss the issues and trends in anti-counterfeiting. The event was held on Janu-

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ary 16-17, 2018 in Mumbai. Various issues from different industries like pharma, auto, FMCG, steel, digital etc were discussed at the event. Eminent speakers like Bejon Kumar Misra, Interna-

tional Consumer Policy Expert & Founder, Patient Safety and Access Initiative of India Foundation; Dr RK Sanghavi, Senior Consulting Clinician Advisor – Positive Health and Chairman, Nu-

traceutical Committee, IDMA and Pradeep Dhargalkar, Head of Packaging Development, Unichem Laboratories represented the pharma sector at the event and informed the audience on the

developments in the sector and the challenges in tacklingcounterfeiting in the pharma industry. Misra spoke on Consumer Awareness: How to help consumers from falling prey to

MARKET counterfeits and their products. He briefed the audience on importance of educating the consumers about the benefits of original products and hazards to counterfeited ones. Dr Sanghavi spoke on the challenges and measures to deal with counterfeiting in the pharma industry. He gave a brief understanding to the au-

Counterfeiting not only affects the sales and revenue of the industry but also dents the reputation of brands and results in heavy revenue losses due to unaccounted sales and a huge challenge to the ‘Make in India’ programme dience on the menace of counterfeiting in the pharma industry and explained that the problem of counterfeit is across the global and this sector requires very strong anti counterfeiting measures. Whereas, Dhargalkar highlighted the major challenges faced by the packaging industry in addressing the counterfeit. He says, “Packaging industries has be one step ahead of counterfeiters and technology which is available for free empowers them to copy or replicate the technology used for anti counterfeit. Only mantra for staying ahead of these counterfeiters is constant innovations and up gradation of technology being

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used in packaging.” Counterfeiting is a global problem and is growing at an alarming rate. Moreover, India is a large market for such activities. India’s booming e-commerce environment has added further complexities. Counterfeiting not only affects the sales and revenue of the industry but also dents

the reputation of brands and results in heavy revenue losses due to unaccounted sales and a huge challenge to the ‘Make in India’ programme. The Indian counterfeit market is growing at the rate of four per cent per annum as per reports. In India, approximately three billion pieces of counterfeit

and pirated products were seized in 2013. Of these, 2.3 billion pieces were illicit pharma products, 470 million pieces were electronic appliances and 50 million pieces were foodstuff. There is annual loss of $2 billion because of counterfeited auto components alone. The event also had a key

note address on the Role of customs to prevent counterfeited goods to make way across boarders by Sunil Kumar, Deputy Comissioner, IRS(Customs and CGST); Overview of the counterfeiting and brand protection issues in India by Capt Shakil Ahmed, Head-Brand Protection, Diageo India.

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Drugs Control Department,NPPAhost workshop in Delhi The theme of the workshop was Accessibility,Affordability & Availability of Pharmaceutical Products THE DRUGS Control Department, Government of NCT, Delhi, in association with National Pharmaceutical Pricing Authority (NPPA) at FICCI, Federation House, Tansen Marg, New Delhi organised a workshop on “Accessibility, Availability and Affordability of Pharmaceutical Products” recently. The purpose of the workshop was to familiarise the health department and other stake holders about various provisions of DPCO, 2013 and other issues regarding accessibility, availability and affordability of essential drugs to the consumers. The workshop was inaugurated by Satyendar Jain, Minister of Health and Family Welfare, Government of NCT, Delhi. In his address, Jain emphasised on ensuring availability of medicines to poor patients at affordable prices. He also shared details on the initiatives of Delhi Government regarding opening of Mohalla Clinics, Providing free diagnostic testing and medicines to every resident of Delhi. He further informed the gathering that the Delhi Government is soon taking steps to ensure that generic medicines are prescribed by doctors in all government hospitals in Delhi and requested NPPA officers to put a cap on the trade margin up to a maximum of 50 per cent. Raajiv Yaduvanshi, Principal Secretary, Health & Family Welfare, Government of NCT of Delhi during his key note address informed that Drugs Control Department, Delhi is committed to curb the pharma drug abuse and has taken zero tolerance stand on the issue. He further added that though the checking of overcharging is the duty of regulators but it is a team work of all stakeholders. Bhupendra Singh, Chairman, NPPA informed that NPPA has fixed ceiling price of 821 scheduled medicines so far including 65 cardio vascular, 12 anti-diabetics, 41 HIV/AIDS, 28

24 EXPRESS PHARMA February 1-15, 2018

tuberculosis and 70 anti-cancer drugs. In addition, NPPA has fixed prices of 106 nonschedule medicines under para 19 of DPCO, 2013 out of which 84 are used for the treatment of cardiovascular diseases and 22 for diabetes. Sudhansh Pant, Joint Secretary, Department of Pharmaceuticals, Government of India explained the importance of 3As included in the title/theme of the workshop. He apprised the audience on the initiatives of government regarding opening of Jan Ausadhi Kendra in the country which is a very significant step in the service of masses and towards making affordable medicines available to the public at large and informed that as on date we are having more than 3000 Jan Ausadhi stores all over the country. He also stressed upon minimising the difference in prices between generic/branded generics and branded medicines. SN Misra, Special Secretary Health, Government of NCT, Delhi during his welcome address stressed that all stakeholders should be committed to work together to achieve the objective of making efficacious and quality medicines available to the consumers at affordable price. Atul Kumar Nasa, Head of Office/Controlling Authority

Drugs Control Department, Government of NCT, Delhi proposed the vote of thanks to all the dignitaries present and all other participating delegates in the workshop and assured the commitment of Drugs Control Department, Government of NCT, Delhi towards stopping pharma drug abuse (drug addiction) and availability of safe, efficacious and quality medicines to the consumers at affordable price. The workshop was attended by various professionals from the pharma industry, IDMA, FOPE, CIPI, BDMA, Officers from NPPA, Officers from Department of Pharmaceuticals, Govt. of India, Officers from Drug Control Department/ CDSCO, Representatives from FICCI, Representatives from Pharmexcil, RDCA, Academicians, PG students from Pharmacy Colleges and Representative from NGOs and Consumer Associations. Various eminent resource persons/speakers delivered their excellent talk/presentations on topics related to the theme of the conference. Rakesh Ranjan, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) delivered a talk on “Mandate, Activities and Achievements of NPPA: An overview” and apprised the audience about various provi-

sions of DPCO and also informed about activities of NPPA and its achievements. BR Sikri, President Federation of Pharmaceutical Entrepreneurs (FOPE) spoke on 'Drugs-Delhites- Industry'. Sikri spoke from industry’s point of view stating that basic mission of the industry is to make everyone healthy. He said that affordability and availability of medicines is contradictory and accessibility to healthcare is responsibility of drugs regulatory authorities. He suggested and requested Government to take initiatives to bring the pharma industry back to Delhi, which shifted to Himachal Pradesh and Uttaranchal, due to tax rebate provided to the investors by the respective state governments. Bejon Kumar Misra, Founder, Patient Safety & Access Initiative, shared his view on “Patients Perspective on Affordability and Accessibility of Medicines”. Bejon further added that the cost of health care to the patient including hospital charges, testing charges along with cost of medicines should be minimised and government needs to take many more steps to this direction. He also proposed that general public should be made aware about NPPA and its achievement/activities

through wide publicity. Kalyan Nag, Advisor, NPPA delivered a talk on “Monitoring and Enforcement Activities of NPPA”. SW Deshpande, Ex Joint Commissioner, FDA (Maharashtra) & Director General, AIDCOC spoke on “Regulatory Intervention to ensure Accessibility, Availability and Affordability of Medicines” putting forth the regulator’s point of view on the issue and enlightened the delegate with various provisions under DPCO from time to time that have been enforced. Arun Mishra, Executive VP, Regulatory Affairs, GSK Consumer Health Care, India delivered a talk on ‘Challenges & Opportunities- Access to Health Care and Medicines in India’. He said that Digital India is fuelling accessibility of medicines. e-consultation, e-pharmacy, e-retail chains and e-diagnostics are changing the healthcare ecosystem which is improving access to healthcare. New innovations like robotics, drone ambulance, remote surgery etc., are also some of the solutions towards better accessibility. APS Sawhney, Director, NPPA highlighted the 'Challenges in Implementation of DPCO, 2013'. Aprajita Takiar, MD, Lark Laboratories (India), spoke on improvisation in healthcare system using modern techniques which is being followed by developed countries who are using model management tools, PPP model, etc. to increase efficiency of manpower in healthcare management. The event also witnessed a panel discussion comprising Subhash Malhotra, MD, Seagull Pharmaceuticals; Jaswant Chauhan, Chairman, Obsurge Biotech; SW Deshpande, Ex-Joint Commissioner, FDA, Maharashtra; PK Jaggi, Chief Pharmacy Services, Delhi State Cancer Institute; and Rakesh Ranjan, IAS – Member Secretary, NPPA, New Delhi to discuss different issues which were raised and deliberated at length.

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GOING GLOCAL IS ITTHE WAY FORWARD? As India Pharma Inc strives to enter new, previously unexplored markets and battles unprecedented challenges, 'Think Global, Act Local' approach might be one of the strategies to derive a competitive advantage By Lakshmipriya Nair

26 EXPRESS PHARMA February 1-15, 2018

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THE MAIN FOCUS

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G

localisation as a concept is nothing new, especially for Indians. Be it our food, clothing, language or culture, we have adopted global trends as well as practices and ‘Indianised’ them to suit our tastes and preferences. Take the Indian Chinese cuisine for instance. Also known as ‘Hakka Chinese’ or 'Desi Chinese', it is an “adaptation of Chinese seasoning and cooking techniques to Indian tastes”. Today, it has become an integral part of the Indian culinary culture. Let’s not forget the Indowestern dresses, a very popular fashion, both in India and abroad. As a very interesting amalgamation of Indian and Western design sensibilities, this fusion is considered one of the most versatile fashion trends and it continues to evolve. But, now glocalisation has evolved into a noteworthy business strategy which underlines the significance of adopting a local approach while upholding brand values. It has emerged as a recognised approach with proven benefits in terms of business growth on a global playing field. McDonald’s Chatpata Naan or Phirni McFlurry, KFC’s vegetarian thali and Chana Snacker, HLL’s strategy to launch shampoo sachets priced at a rupee, MTV India are some good examples of this strategy in the Indian context. These global brands have entered India and transformed themselves into household names while retaining their brand identity, key messages and central philosophy.

Glocalisation and India Pharma Inc India Pharma Inc too has experimented/adopted this strategy, as it expands its footprint and presence in global markets. It is all the more relevant for this industry as it navigates its path to progress through the regulatory maze of different geographies and countries.

28 EXPRESS PHARMA February 1-15, 2018

In developing countries such as India where price plays a major role, it is very essential that global and new technologies are made available at affordable prices. By making this available to the Indian pharma companies the major benefit we offer is a high quality product which is easily accessible to them at any time Rishad Dadachanji, Director, SCHOTT KAISHA

A company should weigh its strengths and weakness critically while planning glocal strategy. Regulatory challenges have cropped up during last few years because of the failure to keep-up the pace with rapidly evolving global quality metrics and transform according to revised standards Dr Ashok Kumar, President - R&D (Chemical), IPCA Laboratories

If functions that involve local cultural barriers or knowledge such as sales & marketing, regulatory, legal are localised, the benefit is faster decision making, closer to where the market is Prashant Tewari Managing Director, USV

The Indian market, though extremely price sensitive, has tremendous potential and hence a carefully thought through India-specific strategy could pay rich dividends. A one size fits all play will not work here Utkarsh Palnitkar Partner, National Head – Infrastructure, Government & Healthcare. National Head – Life Sciences, KPMG

The company aims to get into the Indian market with innovative therapies to help mitigate the healthcare challenges which are very relevant to the country and reach out to as many patients as possible Ashok Bhattacharya Executive Director, Takeda Pharmaceuticals India

Experience across sectors have taught us that the effect of local forces cannot be ignored. A thorough knowledge of these forces and strategic application of it will help the company gain acceptance within its target customer base, build brand loyalty, effectively navigate through market conditions, gain a cost and competitive advantage as well as create meaningful collaborations for long term benefits. Utkarsh Palnitkar, Partner, National Head – Infrastructure, Government & Healthcare. National Head – Life Sciences, KPMG, speaking in his individual capacity, clearly outlines the prerequisites for a glocal strategy and states, “A clearly defined product portfolio which addresses the therapeutic class in which the company operates is vital. Gaps in the bouquet of products which a company deals in could be augmented through in-licensing, alliances. Regulatory challenges are a given and one can’t wish them way. Success will lie in navigating these through nimble strategies rather than fighting them.” Dr Fabrice Egros, President of Asia Pacific and Japan, Lupin also points out, “In an increasingly interconnected and competitive global environment, it is the ability of an organisation to think globally and act locally that sets them apart. This becomes all the more critical for companies in sectors like pharma and lifesciences because of the impact our products can have on a large segment of the population.” Here are a few of the most significant advantages offered by a glocal strategy: Leverage local market advantages: A thorough understanding of the local forces at work will help a pharma company to spot and appreciate the opportunities available in the market it seeks to serve and leverage them effectively. For instance, many pharma companies have been acquiring/creating manufacturing facilities overseas as

( it helps them to manufacture for the local markets easily, get cheaper labour and raw material as well as save on transportation and logistics costs, thereby reducing their overall production and consumption costs.

GLOCALISATION STRATEGIES ◗ Encouraging localisation ◗ Giving a fillip to local economies and interests ◗ Use of IT and communication technology ◗ Mobilising local communities

Prashant Tewari, MD, USV explains it very well. He says, “Almost all large companies from India have own front-ends in all major markets from North America, Latin America, Russia etc. If functions that involve local cultural barriers or knowledge such as sales & marketing, regulatory, legal are localised, the benefit is faster decision making, closer to where the market is. Better customer engagement and thereby brand loyalty: A glocal strategy enables a company to engage the customer better and create products/services which are better suited for that market. It also makes the company more agile, adaptable and responsive. Insights gained from operating in these markets can be used in turn to further facilitate progress. Faster acceptance and brand loyalty is another major advantage. Effective resource management: Glocalisation also enables a pharma company to develop closer and long-term relationships with local suppliers and create a more efficient and better functioning supplychain networks. For pharma companies, this could be a great competitive advantage. Moreover, these companies can also emerge as significant job creators. It can become a source of nurturing local talent. In turn, resident employees can be a very effective source for insights into the market.

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Improved adherence to regulations: In times of increased regulatory scrutiny, glocalisation may turn out to be an ally. Knowing the market well and adapting to the local conditions could be a crucial step towards

ensuring regulatory adherence. Moreover, a local workforce is a fount of information and can help ensure that regulations are better understood and followed to the letter to enable business success. An effective

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glocal strategy can also be key to navigating political and judicial structures which dictate the norms of privacy, patent concerns, and censorship. Dr Ashok Kumar, President - R&D (Chemical), IPCA Labo-

ratories highlights, “A company should weigh its strengths and weakness critically while planning glocal strategy. Regulatory challenges have cropped up during last few years because of the failure to

cover ) ACG Worldwide: Going near your customers

keep-up the pace with rapidly evolving global quality metrics and transform according to revised standards. Having trained and qualified people at right place shall help the companies devise global strategies, whilst remaining rooted to home turf.” Provide social value: As pharma companies enter new markets and devise glocal market access strategies they also contribute to meet underserved healthcare needs and increase access to medicines. At the same time, as they set up thriving businesses, glocalisation also helps the country grow and encourage development. These businesses also contribute to local economies and get an opportunity to emerge as a credible and trustworthy organisation. Thus, as a global brand entering distinct markets, the glocal advantage can be key to progress. So, how has the life sciences sector leveraged this strategy to accelerate their growth? A few leading players in the pharma industry share their glocal strategies with ExpressPharma.

Lupin: Customising according to cultural norms Dr Egros explains about Lupin’s glocal strategy and says, “As a transnational company with successful operations in more than 100 countries across the world, our glocalisation efforts have focused on two primary objectives: leveraging our capabilities as a global generics powerhouse and matching our products to the individual markets we cater to.” Citing an example, he narrates, “Traditionally, Japan has been a challenging market for a lot of global and Indian pharma companies, however it has emerged as the third largest market for Lupin – a testimonial to our approach to glocalisation. An example of this is the sensitivity around the overall finish and size of the pharma tablets which is very

30 EXPRESS PHARMA February 1-15, 2018

Many of our customers are buying companies overseas and very often they tell us that they need us to be there as well. So, we are looking at both, greenfield and brownfield projects, to be near our customers and provide them with value Karan Singh MD, ACG Worldwide

In an increasingly interconnected and competitive global environment, it is the ability of an organisation to think globally and act locally that sets them apart Dr Fabrice Egros President of Asia Pacific and Japan, Lupin

EVOLUTION OF GLOCALISATION The term “Glocalisation”can be traced to a word “dochakuka”in Japanese culture which means global localisation. It initially referred to Japanese practices of adapting farming techniques to local conditions. Since then it has evolved into an important business strategy.The concept was later popularised by a number of sociologists, in the 1990s, namely Roland Robertson, Keith Hampton, Barry Wellman and Zygmunt Bauman.They refer to people who are actively involved in both local and global activities of commerce. Source: https://www.sibm.edu/assets/pdf/glocalisation.pdf

specific to Japan – a factor often overlooked by other manufacturers. Another element very peculiar to Japan is the cultural norms that permeates both the professional and personal spheres in Japan, a hurdle we have overcome by implementing the lessons we have learnt through acquisitions such as Kyowa and partnerships with local Japanese pharma companies like Shionogi, Astellas, and others.”

IPCA Laboratories: Venturing into new growth areas IPCA is looking at growth through product expansion and glocalisation has helped it to look at areas and markets which will drive accelerated growth. Explaining the rationale behind the move, Dr Kumar updates, “The strategy opted by large MNCs, mainly focusing on therapeutic areas where the development of new drugs takes less time helping them quickly replacing old ones with

As pharma firms enter new markets and adopt glocalisation they help meet underserved healthcare needs and increase access to medicines improved versions has proven to be a game-changer for them, but a nightmare for Indian generic companies because it may not have the availability of more blockbusters in the

future to replicate and have good/sustainable returns.” He further elaborates, “Therefore, given that quite a good number of major multinational pharma players are also venturing into generic drugs arena to increase the size of their profit pie and the intensified competition at the home turf becoming yet fiercer; it becomes imperative to be glocal and think beyond physical boundaries. Only getting out of the comfort zone can now help companies withstand aggressive competition.” “We keep revisiting our strategies according to changing global pharma business dynamics. Driven by inherent and acquired strengths we have been diversifying and venturing into high value businesses. Development of biosimilars and also of small molecules with better efficacy and broad combination therapy indications are few examples reflecting our glocal strategy, he informs.

ACG is planning to expand globally and penetrate into regulated markets like Europe and the US. It has facilities in Eastern Europe and South America. In fact, in a conversation with this writer at CpHI India, Karan Singh, MD, ACG Worldwide has informed that the company will be inaugurating its second facility in South America in about six months to locally manufacture capsules and films. The company expects these facilities overseas to help strengthen and consolidate the company’s footing and position in these markets. Elaborating on their glocal strategy, Singh says, “What we are seeing is that many of our customers are buying companies overseas and very often they tell us that they need us to be there as well. However, often it is difficult to pick up existing facilities that manufacture capsules and films. So, often we have to set up greenfield projects. So, it is mix, we are looking at both, greenfield and brownfield projects, to be near our customers and provide them with value.” He mentions harmonising as a major challenge in brownfield facilities and beginning everything from scratch in greenfield projects. However he feels that the company is also de-risking to some extent with these measures. Though ACG hasn’t faced any issues in trade so far due to international regulations, he feels that in case protectionist policies become an issue, import duties are proposed, trade becomes difficult and borders are closed, then ACG would already have a local presence in major pharma hubs of the globe.

Schott Kaisha: Leveraging Technology Schott Kaisha has effectively used technology to bring in value to the pharma sector in India. Rishad Dadachanji, Director, SCHOTT KAISHA elaborates on their strategy and informs, “In developing

( countries such as India where price plays a major role, it is very essential that global and new technologies are made available at affordable prices. If packaging companies such as Schott Kaisha do not offer new and innovative ideas it would restrict Indian companies from being able to provide an equivalent product at affordable prices in the market. By making this available to the Indian pharma companies the major benefit we offer is a high quality product which is easily accessible to them at any time.” “Our plants are set up based on a global standard and are equipped with the most updated technology that the industry has to offer. We have worked with our partners and developed systems with the capability to offer very high accuracy and consistency in its respective functions. This enables us to offer the Indian pharma companies high quality products at reasonable prices,” he further informs.

Glocalisation for India market Thus, while Indian companies are revisiting their strategies for the overseas markets, experts feel that the MNCs in the life sciences sector looking to tap the Indian market also should create a strategy which is country-specific. Palnitkar advises, “The Indian market, though extremely price sensitive, has tremendous potential and hence a carefully thought through India-specific strategy could pay rich dividends. A one size fits all play will not work here.” He also asserts, “I think a two-pronged strategy, will help pharma companies balance out the risk associated with focusing on one geography alone. Having said that, a very different approach to the market will have to be adopted. Replicating what works in other markets will not hold good for India. “There are several examples of well positioned products

FUNDAMENTALS OF GLOCALISATION AS A BUSINESS STRATEGY 1) Localisation – Requires the company getting into a country to know its culture, customs, regulations, and local medical practices 2) Global operations – It requires a sound understanding of technological advancements and adequate global capabilities. 3) A thorough understanding of the target customers and ways of making a product or service locally relevant

that have been able to make a difference. In the last few years, for example the manner in which some brands have been able to carve a footprint has been remarkable, Januvia for example,” he points out. The companies too have realised this fact and are now tailoring their approaches to suit the Indian market. Takeda

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Pharma is one such example. Ashok Bhattacharya, Executive Director, Takeda Pharmaceuticals India explains that his company is very keen to leverage the opportunities in the Indian market. He further informs that the company aims to get into the Indian market with innovative therapies to help mitigate the healthcare challenges which are very relevant to the country and reach out to as many patients as possible. For instance; diabetes, GI, oncology, etc. are its areas of focus. This, in turn, will help the company bring in the highest differentiation in the Indian market. Similarly, DuPont intends to widen the application and adoption of Tyvek, a durable, lightweight fabric that can be used for wide range of packaging uses, in the life sciences sector. In conversation with Express Pharma at CphI India, representatives of the company, Shyam Patnaik, South

Asia leader, Tyvek and Suolong Ni, Regional Sales Leader, Tyvek informed that their major objective at the event was to understand the Indian pharma market and its requirements comprehensively so that they can use these insights serve the industry better. Companies are realising that the Indian market has certain peculiarities and they need to be taken into consideration to gain inroads in this market.

A glocal future? Thus, glocalisation has the potential to be a solution to the struggle that international businesses have battled between global and local demands. If well implemented, good glocal strategies can help create more cohesive and healthy business environments, increase the quality of products and services and drive down prices, making drugs more accessible. lakshmipriya.nair@expressindia.om

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MANAGEMENT

Legal aspects to maintain quality standard of drugs Rajdutt Shekhar Singh, Partner, Singh & Associates, talks on the laws governing the pharma sector and recent intitiatives to improve quality

T

he Indian pharma industry is presently the third largest in the world (volume wise). In terms of value, the size of the industry is approximately `200,000 crores ($30 billion), out of which more than half is exported to different countries across the globe.1 The Drugs and Cosmetics Act, 1940 (D&C Act) and Drugs and Cosmetics Rules, 1945 (D&C Rules) regulate the import, manufacture, distribution and sale of drugs in India. All the drugs (either imported or manufactured in India) are required to comply with the standards as specified in the Second Schedule of the D&C Act (Schedule). The Schedule provides details of the class of drugs and the standards to be complied with by such class of drugs. For instance, as per the Schedule, drugs which are included in Indian Pharmacopoeia (IP), such drugs are required to comply with the standards of identity, purity and strength specified in the edition of the IP (and such other standards as may be prescribed). Similarly, drugs which are not included in the Indian Pharmacopoeia but are included in the official Pharmacopoeia of any other country, in such cases standards of identity, purity and strength specified for drugs in the edition of such official Pharmacopoeia of any other country (and such other standards as may be prescribed) are required to be complied with. In addition, import2 and manufacture 3of drugs (which are not of standard quality, misbranded, adulterated or spurious) are prohibited under the D&C Act. In order to provide stringent penalties for manufacture of spurious and adulterated drugs, the D&C Act was amended in 2008 and various offences have been made cognizable and nonbailable under the D&C Act. In addition, the amount of penalty has also been increased from `10,000 to `10 lakh or three times value of the drugs confis-

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cated, whichever is more. However, after introduction of the aforesaid amendments in the D&C Act, the Central Drugs Standard Control Organisation (CDSCO) formulate guidelines4 as per which the CDSCO categorised drugs (which are not of standard quality) into three categories viz. Category A (Spurious and Adulterated Drugs), Category B (Grossly sub-standard Drugs) and Category C (Minor Defects). The Guidelines inter alia provide directives to the State Drugs Authorities which states as follows, “Care should be taken that while violations with criminal intent or gross negligence leading to serious defects are dealt with heavy hand, the violations involving minor variations in quality by licensed manufacturers are resolved through administrative measures”. Accordingly, the Guidelines inter alia state that in the case of not of standard quality reports because of minor defects 5 arising out of variations from the prescribed standards or contraventions of other provisions of chapter IV of the D&C Act, administrative measures including suspension/cancellation or compounding of offences may be resorted to. Further, Ministry of Health and Family Affairs devised a reward scheme for whistle blowers in the fight against the menace of spurious or fake drugs, cosmetics and medical devices.6 This reward scheme provides rewards to the informers who provide specific information to the designated authorities leading to the seizures of spurious, adulterated, misbranded and not of standard quality drugs, cosmetics and medical devices. As per this reward scheme, reward is to be given only when there is a confirmation of the seizure of spurious, adulterated and misbranded drugs, cosmetics and medical devices by the designated officers of the CDSCO. There is a provision that

reported incidents of safety and efficacy received for all drugs including vaccines and biological. The said guidelines provide recall classification and recall procedure and all the manufacturers, importers, stockists, distributors, retailers are required to follow these guidelines for recalling of defective drugs.

Drugs regulators’ recent initiatives

the reward of maximum of up to 20 per cent of the total cost of consignments seized is to be payable to the informer which should not in any case exceed `25 lakhs in each case. In order to spread awareness on real time basis regarding drugs which are not of standard quality, the CDSCO publishes drug safety alert on monthly basis on its website. The monthly publication of drug safety alert includes a list of drugs which are declared as ‘Not of Standard Quality, spurious, adulterated or misbranded along with the details of batch No. and manufacturing site. The list also mentions the details of testing laboratories which perform the quality test of drug along with the reason of failing the test for the particular drug. In addition, where any person has been convicted for contravening any of the provisions of the D&C Act or Rules made there under (including without limitation manufacturing of drugs not of standard quality), the stock of the drug in respect of which the contravention has been made is liable to confiscation. At the same time, the regulatory regime also provides compounding of certain offences 7under the D&C Act. In November 2012, the CDSCO introduced guidelines on recall and rapid alert system for drugs.8 These guidelines are applicable to all quality defective product reports and to all

The central drugs regulator, CDSCO issued draft Standard Operating Procedures (SOPs) for handling of not of standard quality drug samples. As per the draft SOPs, whenever the analysis result of any sample is not within the range of specified limits, it is referred to be Not of Standard Quality (NSQ)/out of specification (OOS).9 Further, as per recent media reports, the Drug Controller General of India (DCGI) is preparing a plan to ensure that drug testing laboratories meet the prescribed good laboratories practice (GLP) norms.10 It is also noted that the Maharashtra Food and Drugs Administration cancelled 58 manufacturing licenses and suspended 145 licenses based on various inspections carried out on manufacturing units in Maharashtra.11

Conclusion In the recent times, Indian Drugs Regulators have become more vigilant to ensure that drugs manufacturers maintain standard of quality of drugs. At the same time, Drugs Regulators are also minded of the fact that drugs manufacturers (whose drugs qualify as a drug not of standard quality due to minor defects) should not be subject to stringent penalty. India has emerged as one of the most preferred destinations for export of drugs and various Indian pharma companies have US Food and Drug Administration (USFDA), MHRA (UK), TGA (Australia), MCC (South Africa), Health Canada etc.

approved plants, for generic drugs manufacture. Ironically, USFDA raised concerns on the quality and efficacy of medicines being sold in India. In the backdrop of the stringent penal provisions, drugs manufactures are required to carry out necessary checks and balances as per the provisions of the D&C Act and Rules for maintaining required standard of quality of drugs and they should be encouraged to initiate legal and regulatory audits on regular intervals. References 1. http://www.indiaenvironmentportal.org.in/files/file/ National%20Drug%20 Survey%202014-16.pdf 2. Chapter III of the D&C Act. 3. Chapter IV of the D&C Act. 4. Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008. 5. As per the Guidelines, examples of minor defects are: Broken or chipped tablets, presence of spot/discolouration/ uneven coating, cracking of emulsions, clear liquid preparations showing sedimentation, Change in colour of the formulation, Slight variation in net content, formulations failing in weight variation, formulations failing to respond to the colour test, isolated cases of presences of foreign matter, labelling error including nomenclature mistake, Rx, NRx, XRx, Red Line, Schedule H. Caution, Colour etc. 6. http://www.cdsco.nic.in/ Whistle%20Blowe%20(3).pdf 7. Section 32-B of the D&C Act. 8. http://www.cdsco.nic.in/ writereaddata/Guidlines%20on%2 0Recall.pdf 9. http://pharmabiz.com/ArticleDetails.aspx?aid=102585&sid=1 10. http://www.livemint.com/Industry/wd3INVcJwMx4X16M8gY 3mJ/DCGI-plans-surprise-testsin-labs-to-check-drug-quality.html 11. http://pharmabiz.com/ArticleDetails.aspx?aid=103920&sid=1

RESEARCH UPDATES

Novartis’Promacta receives FDAbreakthrough designation for new indication The drug has been approved as a first-line treatment of severe aplastic anaemia

N

ovartis drug Promacta has received breakthrough therapy designation from the US Food and Drug Administration for first-line treatment of severe aplastic anaemia. The drug has received the designation for use in combination with standard immunosuppressive therapy in treating the rare blood

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disorder in which a patient’s bone marrow fails to produce enough red blood cells, white blood cells and platelets, the Swiss drug maker said recently. Promacta is already approved as a second-line therapy in SAA, as well as for adults and children with chronic immune thrombocytopenia.

Breakthrough status is a designation given to treatments demonstrating substantial improvement over existing therapies in treating a serious or life threatening illness. Novartis said it expects regulatory filings in both the US and the European Union this year. Reuters

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RESEARCH

ADHD drug tied to heart defects in babies Among children of women who were not taking stimulants for ADHD, 35 out of every 1,000 babies had birth defects, compared with 46 out of every 1,000 infants born to women using drugs like Ritalin PREGNANT WOMEN who take drugs like Ritalin and Concerta for attention deficit hyperactivity disorder (ADHD) are more likely than those who don’t to have babies with heart deformities and other birth defects, a recent study suggests. Researchers examined data on more than 1.8 million pregnancies in the US, including 2,072 women who used methylphenidate (Ritalin, Concerta, Daytrana) and 5,571 who took an amphetamine (Adderall) during their first trimester. Overall, women who took methylphenidate were 11 per cent more likely to have a baby with birth defects and 28 per cent more likely to have infants with heart malformations than women who didn’t take stimulants for ADHD during pregnancy. There was no increased risk of birth defects in general or heart malformations specifically with amphetamines like Adderall, the researchers found. “Our findings suggest that there might be a small increase in the risk of cardiac malformations associated with intrauterine exposure to methylphenidate,” said lead study author Krista Huybrechts of Harvard Medical School and Brigham and Women’s Hospital in Boston. “Although the absolute risk is small, it is nevertheless important evidence to consider when weighing the potential risks and benefits of different treatment strategies for ADHD in young women of reproductive age and in pregnant women,” Huybrechts said by email. An estimated three per cent of children, teens and adults have ADHD, researchers note in JAMA Psychiatry. Stimulants like Adderall and Ritalin are

34 EXPRESS PHARMA February 1-15, 2018

among the most commonly prescribed medications for the condition, and these drugs are increasingly being used by women of childbearing age. All of the women in the current study had health insurance through Medicaid, the US benefits programme for the poor. Among children of women who were not taking stimulants for ADHD, 35 out of every 1,000 babies had birth defects, compared with 46 out of every 1,000 infants born to women using drugs like Ritalin. To assess whether these results were unique to the US or to women on Medicaid, researchers also examined health registry data for more than 2.5 million pregnancies in Denmark, Finland, Iceland, Norway and Sweden. In the Nordic data, drugs like Ritalin were also associated with a 28 per cent higher risk of heart malformations in babies. The study wasn’t a controlled experiment designed to prove whether or how specific ADHD drugs might cause birth defects. Because the study only included live births, it didn’t explore whether the drugs might increase the risks of severe birth defects that lead to miscarriage

or stillbirths or that prompt women to terminate pregnancies, the authors note. “If a woman has mild symptoms, it might be possible to avoid use of the medicine during pregnancy,” said Dr William Cooper, a researcher at Vanderbilt University Medical Center in Nashville, Tennessee, who wasn’t involved in the study but wrote an accompanying editorial. “However, if the woman has severe symptoms that interfere with her daily function, the results of this study can help to guide decisions on whether to continue,” Cooper said. It may also make sense for some women with ADHD to consider stopping or changing medications when they’re trying to conceive, Huybrechts said. “Considering the high rate of unplanned pregnancies among young women, the potential for accidental exposure is also very high,” Huybrechts said. “Although the absolute risk is small, it is nevertheless important evidence to consider when weighing the potential risks and benefits of different treatment strategies for ADHD in young women of reproductive age and in pregnant women.” Reuters

Cancer targeted with reusable ‘stinging nettle’ treatment CANCER CELLS are killed more effectively and selectively with a new approach, using a substance found in stinging nettles and ants, informs a study. Led by Professor Peter J Sadler from Warwick’s Department of Chemistry, researchers have developed a new line of attack against cancer: an organic-osmium compound, which is triggered using a non-toxic dose of sodium formate, a natural product found in many organisms, including nettles and ants. Named JPC11, it targets a metabolic process which cancer cells rely on to survive and multiply. It does this by converting a key substance used by cancer cells to provide the energy they need for rapid division (pyruvate) into an unnatural lactate leading to the cells’ destruction. Uniquely, this chemo-catalyst treatment can be recycled and reused within a cancer cell to attack it repeatedly. This unprecedented functional ability to recycle and reuse the compound within cancer cells could lead to future anticancer drugs being administered in smaller, more effective, and potentially less toxic doses, decreasing the side-effects of chemotherapy. The researchers have been focussing on the potential to use this compound on ovarian and prostate cancers. Importantly, the development opens up a possibility for a more selective cancer treatment as JPC11 was observed to specifically target the biochemistry of cancer cells, leaving healthy cells largely untouched – another improvement compared to existing platinum-based drugs, which can also attack non-cancerous cells. Dr James Coverdale, Research Fellow, Warwick’s Department of Chemistry, said, “This is a significant step in the fight against cancer. Manipulating and applying well-established chemistry in a biological context provides a highly selective strategy for killing cancer cells. We have discovered that chemocatalyst JPC11 has a unique mechanism of action – and we hope this will lead to more effective, selective and safer treatments in future.” Professor Sadler commented, “Platinum compounds are the most widely used drugs for cancer chemotherapy, but we urgently need to respond to the challenges of circumventing resistance and side-effects. Chemo-catalysts, especially those with immunogenic properties, might provide a breakthrough. ” Professor Martin Wills, catalyst specialist at University of Warwick, commented, “Although asymmetric catalytic hydrogenation processes are well developed in the materials industry, this research provides the first ever example of it being achieved inside cells using a synthetic catalyst.” Handedness (molecular asymmetry) is critical to the function of bio-molecules in the body. Proteins, enzymes and our DNA, for example - are handed. Only the correct hand works, in the same way that a right hand does not fit a left-hand glove. In this case, the osmium compound JPC11, with sodium formate, can selectively produce a molecule of a specific ‘handedness’ – thus manipulating how cancer cells grow. Dr Coverdale explained, “The ‘handedness’ of molecules is critical in the body. Our hands are near-identical, but are mirror images of each other. The same can be true of molecules, and in some cases, having the wrong handed molecule can have profound biological consequences. We believe that manipulation of the ‘handedness’ of molecules in cells could provide a new strategy for fighting diseases.” EP News Bureau

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PHARMA ALLY VENDOR NEWS

Romaco appoints Jörg Pieper as CEO Pieper will be in overall charge of sales and customer service, product management, marketing and international strategy development

J

örg Pieper has been appointed as the new CEO of Romaco with immediate effect by the Advisory Board of Romaco Holding. He directly succeeds Paulo Alexandre, who has left the company. The Advisory Board would like to thank Alexandre for his contribution to the firm’s expansion during the last six years. Pieper joined Romaco Holding in 2011. As Vice President Customer Service, he was initially responsible for establishing customer service throughout the Group. In

2013, he transferred to Romaco Kilian as Managing Director, playing a major part in the tablet press manufacturer’s success story. Prior to his arrival at Romaco, Pieper held various top-level management positions at European and American corporations in the component industry and the machine building sector. The Karlsruhe (Germany)based Romaco Group is currently undergoing a strategic realignment following the acquisition of a majority interest by the Chinese Truking In-

vestment, at the beginning of July 2017. “Jörg Pieper, Romaco’s new CEO, is a proven industry expert with an in-depth knowledge of Asia,” emphasised Yue Tang, Chairman, Truking. “With him at the helm, the company will have a chance to concentrate on its core competencies and systematically strengthen the innovation capability of its seven brands.” In his role as CEO of the Romaco Group, Pieper will be in overall charge of sales and customer service, product management, marketing and

international strategy development. “We are aiming to give an entirely new meaning to the term ‘close to the customer’ and to simultaneously strengthen our service mentality,” said Pieper. “In the future, it will be particularly important to anticipate the needs of our customers worldwide, to enable us to respond promptly and flexibly to changing market requirements.” Carsten Strenger will remain CFO/COO of Romaco Holding with responsibility for Finance and Operations. EP News Bureau

Agilent in scientific collaboration with University of Southern California Collaboration aims to facilitate transformational biomedical science and engineering research AGILENT TECHNOLOGIES has formed a strategic scientific collaboration with the University of Southern California (USC) Michelson Center for Convergent Bioscience to create an Agilent Center of Excellence (CoE) in Biomolecular Characterization. The centre will be housed in Michelson Hall, which opened at the university in October 2017. A state-of-the-art research facility, the aim of the centre is to establish a convergence of researchers across science and engineering to work together on multi-disciplinary approaches for the development of improved healthcare through new drugs, diagnostics, and medical devices. The Agilent CoE will provide a collaborative scientific environment with access to

36 EXPRESS PHARMA February 1-15, 2018

new Agilent instrumentation and technologies for undergraduate and graduate students, local customers, and offer broad exposure to researchers who are leaders in their respective fields. “Agilent’s collaboration with the Michelson Center is an excellent example of how academia and industry can work together, sharing knowledge and expertise to shorten the timeline between scientific discoveries and real-world applications,” said Darlene Solomon, Senior VP and Chief Technology Officer, Agilent. “Convergent bioscience research requires successful collaboration across multiple disciplines – a holistic approach that is central to Agilent’s view of the future.” Key to the Agilent CoE will be a collaboration with

The centre will be housed in Michelson Hall, which opened at the university in October 2017 renowned USC Michelson Center for Convergent Bioscience principal investigator Dr Valery Fokin. Research at the Fokin lab at USC focusses on chemical reactivity and biological interactions at the molecular level. The lab will contribute to multiple collaborative drug discovery

projects ranging from chemical synthesis of screening and focussed libraries and biological assay implementation to the development of targeted drug delivery systems, diagnostics, and vaccines. “As convergent bioscience becomes a major contributor to scientific knowledge and ultimately improved human health, academic and industry collaboration will play a key role,” said Stephen Bradforth, divisional dean for natural sciences and mathematics at the USC Dornsife College of Letters, Arts and Sciences. “I’m pleased that Agilent has the vision to support our efforts in this important emerging research field.” Additional notable contributors to this collaboration include Dr Steve Kay, who is

Provost Professor of Neurology, Biomedical Engineering and Biological Sciences. Dr Kay’s research into highthroughput genomics and chemical biology have been integral to the understanding of circadian rhythms, and he is recognised as one of the world’s top experts in this area. Other contributors are Dr Raymond C Stevens, Provost Professor of Biological Sciences and Chemistry, and Dr Peter Kuhn, Dean’s Professor of Biological Sciences. Dr Stevens and Dr Kuhn are among the world’s most influential biomedical scientists; their research on structural biology and cancer metastasis have led to significant advances in medical treatments and pharmaceutical drugs. EP News Bureau

Copley Scientific launches BAC 2100 Breath Actuation Controller Advanced features include a fully automated in situ cascade impactor leak testing function and extensive data reporting capabilities

THE NEW BAC 2100, which replaces its predecessor, the BAC 2000, provides flow control for a range of MDI applications, including a time delay feature for the actuation of MDIs when used with spacers and valved holding chambers (VHCs) according to new USP Chapter <1602>. It can also be used for flow volume control when testing regular MDIs according to USP Chapter <601> and for the automatic actuation of breathactuated MDIs. Advanced features include a fully automated in situ cascade impactor leak testing function and extensive data reporting capabilities, with the choice of outputting data to a printer or computer. Test duration is calculated automatically from the required flow volume – typically two litres in the case of MDIs – based on the measured flow rate, derived from a connected flow meter. The menu system has further been enhanced to guide the user through the required steps to ensure consistency and error free completion of the test method. As an optional accessory to the BAC 2100, a new MDI Actuation Sensor has been made available; a discrete device that clips onto the MDI canister, it senses the manual actuation of the MDI

and precisely triggers the BAC 2100 for subsequent time delay and/or flow volume control, simplifying testing for the user and enhancing reproducibility of testing. Anna Sipitanou, Business Development Manager, Copley Scientific, comments, “After the successful launch of our new TPK 2100, we identified the value of transferring much of the technology across to MDIs, where recent additions to the USP chapters relating to MDIs call for a range of parameters to be controlled and monitored, like for DPIs. This need led us to the creation of BAC 2100 which has been designed specifically for assisting analysts to perform MDI testing in a consistent and reproducible manner, but also eases the process of moving a drug application forward by satisfying regulators with robust data reporting functions. We can see the BAC 2100 becoming the new benchmark for MDI testing.” In addition to the launch of the new BAC 2100, a new BAC 2100-R is being release in parallel. This is a modified version where the flow inlet and outlets are reversed to allow for different arrangements of the test equipment to be located on the laboratory bench. EP News Bureau

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PHARMA ALLY PRODUCTS

Gandhi Automations’dock levellers ensure efficient unloading of goods GANDHI AUTOMATIONS is India’s No.1 entrance automation and loading bay equipment company. This widely recognised position has been achieved over years of hard work, innovation, commitment to quality and reliable customer service. The company is also proud to be certified to ISO 9001 : 2008. Since its inception in 1996, the company has manufactured, imported, distributed and installed products that are problem free and easy to operate. The company offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses. Electro-hydraulic dock levellers offered by Gandhi Automations are not only ‘a bridge for connecting a vehicle,’ but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.

plied and engines shut off. This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveller connects to the truck bed for loading / unloading to take place. At the end of the loading/ unloading the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process.

Following are the two types of dock levellers

Efficient loading and unloading of goods The importance of efficient loading of goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently lesser qualified manpower is being utilised which leads to damage in the goods. The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the

38 EXPRESS PHARMA February 1-15, 2018

investment that goes into the process. Gandhi Automations has always designed solutions based on such scientific approach and feedback from clients. The dock levellers offered by the company ensure loading and unloading with

lesser effort and minimal cost. It is possible to load and unload products in a safe way and in the process obtain remarkable energy savings. The loading bay remains with the dock leveller in rest position and the sectional overhead door closed,

until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers. The sectional overhead door is then opened only when the vehicle is positioned, brakes ap-

a) Radius lip dock levellers Radius lip dock levellers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc. The self-cleaning lip hinging system does not retain rubbish with automatic end-of-run, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349. b) Telescopic lip dock levellers Telescopic lip dock levelers are ideal for connecting vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc. These types can be supplied with a lip extending up to 1 m. Gandhi Automations’ dock levellers are equipped with the most secure safety devices and accessories. Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

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Inventrom launches complete temperature and humiditymonitoring solution BTHM has proven to be 10x faster in response, and more accurate than chart recorders already present at facilities INVENTROM, a Bengalurubased IoT solutions company has launched BTHM - Bolt Temperature and Humidity Monitor, which is a complete monitoring solution for deep freezers, refrigerators, cold rooms and dry rooms in pharma companies.

Say goodbye to chart recorders!

Contact details Inventrom (L) +91 88811 97198 (M) +91 95033 70833 79, 11th Cross Rd, Binnamangala, Indiranagar, Bengaluru, Karnataka - 560038

The BTHM is a big departure from the age-old chart recorders in several ways. Firstly, the BTHM gives real time alerts over SMS/Email in case the temperature or humidity crosses a pre-defined threshold.

BTHM Dashboard

The BTHM also comes in two different variants - The BTHM Standalone unit and BTHM - External Probe. The Standalone unit is used for ambient temperature/humidity monitoring in dry rooms, cold rooms, and pharma warehouses. For monitoring temperature in sub zero conditions inside refrigerators and deep freezers, the External Sensor probe comes attached with the BTHM unit. BTHM - Bolt Temperature and Humidity Monitor

Over the past two years, the BTHM has been tested extensively in pharma labs and production facilities, where it has proven to be 10x faster in response, and more accurate than the chart recorders already present at the facilities. After several iterations and months of research, a vendor based out of Switzerland was chosen to source the on-board sensors, which boast an operating range of -40 to +1250 celsius. As shown above, the BTHM has an LCD display and a physical hooter to alert floor managers about temperature/ humidity excursions. The unit comes with a stand, and can also be mounted onto freezers/ on the wall easily. The installation process is super easy and requires no extra investment.

The alerts are automatically escalated to higher management via SMS / Email, even when they are far away from the site. Secondly, the BTHM comes along with a dedicated dashboard, which can be accessed remotely on any Internet-enabled system.

BTHM Dashboard The dashboard, as seen above, lets you visualise the temperature and humidity data in the form of a graph, or any other desired format. Keeping audit requirements and 21-CFR guidelines in check, the dashboard also lets you download tamperproof temperature data with just one click. The best part about the dashboard is that it can be accessed from any internet enabled system, eliminating the need to install a dedicated software.

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ture excursions, thereby saving them from having to discard an entire lot of products. The BTHM ships all over India and comes along with all relevant IQ/OQ/PQ documentation.

The BTHM is a perfect replacement for chart recorders. Not only does it send me alerts over SMS, but also saves me the trouble of logging data manually - Nigel Fernandes Molbio Diagnostics (Verna, Goa)

External sensor module Already live in Goa-based pharma labs and diagnostic centers, the BTHM has already helped its users save time, money, and resources. Moreover, the remote alerts over SMS/Email have also helped them take corrective action at the right time during tempera-

External Sensor Module

Part Number

Model #

Description

Sensor Range

Sensor Resolution

Data Log Frequency

1

BTHM-1S

BTHM-1S is the Standalone unit. Includes LCD Display, Integrated sensor, access to dedicated dashboard.

-40°C to +125°C, 0 to 100% rH

0.015°C, 0.03RH

Upto 5mins

2

BTM-1E

BTM-1E is the unit with External probe. Includes Display unit, Connecting wire and External temperature sensor probe.

-50°C to +150°C

0.1K

Upto 5mins

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PHARMA ALLY VALUE ADD

What does modularityoffer in the digitisation of industrial production? DIVIDELLA IS working with Medipak Systems sister companies to find new answers to the question of what does modularity offer in the digitisation of industrial production. digitisation, including the use of big data and interconnectivity has considerable potency in generating sustainable competitive advantages for the pharma industry, particularly in embracing Industry 4.0 design philosophies. However, to take maximum advantage of ‘smart’ technologies means embracing a modular approach at every level from design concepts to engineering, construction and processes. This is essential to fully exploit the connectivity and data-sharing that are inherent parts of the Industry 4.0 concept and its Pharma 4.0 derivative.

Modularity in the digitisation of industrial production Essentially, modularity offers advantages in the move to digitised pharma production by promoting greater interconnectivity, interoperability, datasharing and information transparency, allowing much higher levels of technical support and decentralised decision-making. Dividella is part of a wider modular Medipak Systems group ecosystem of related skills and competences in which Dividella combines process and machinery expertise with Rondo, Werum IT Solutions, Fargo Automation, Mediseal and Seidenader, using latest information and communications technologies. This concerted move towards a digitised Industry 4.0 future provides a wider range of innovative solutions on materials and packaging together with easier upgrade and expansion paths.

40 EXPRESS PHARMA February 1-15, 2018

Industry 4.0 Industry 4.0 is the fourth revolution in production, following on from mechanisation, mass production and computerised automation. It describes the adoption of data exchange and artificial intelligence (AI) in manufacturing technologies leveraging ‘cloud’ stored data, cognitive and cyber-physical computing and the Internet of Things (IoT). Industry 4.0 creates smart factories that are structured on modular lines, employing cyberphysical systems to monitor physical processes, creating virtual models of physical processes and decentralizing decision-making. Cyber-physical systems can intercommunicate in real time over IoT, allowing participants to offer and share internal and cross-organisa-

tional services across the whole value chain. To harness Industry 4.0 advantages, solutions must obey four basic principles: 1. Interoperability: As devices, sensors, platforms and people become increasingly able to interconnect and share data via the Internet and IoT, it becomes possible to add further levels of automation. Interoperability depends on modularity. 2. Information transparency: The ability of information systems to create virtual models by combining digital plant systems with real time sensor data to create higher-value content. This requires interconnectivity, a further benefit of modular design. 3. Technical assistance: Both in ability to aggregate and visualise information to solve urgent problems and also create cyber

physical systems that can take on problematic tasks. 4. Decentralised decisions: Cyber physical systems that are able to make decisions and perform tasks autonomously, only delegating to humans in exceptional circumstance.

Pharma 4.0 ‘Pharma 4.0’ applies Industry 4.0 concepts to revolutionise and transform the pharma industry, from outflowing goods to feedback of real-time patient data. It is part of an overall trend to more individualised therapies that creates evergreater need for quality data and diverse formats. With this comes more pressure to make smarter use of data to avoid production bottlenecks in a Just in Time (JIT) world. The trend towards person-

alised therapies requires a shift from in flexible mass production to manufacturing individually tailored products. This transformation depends on changing the perception of data and content in three main areas: ◗ Moving away from paper: Many so-called ‘state-of-the-art’ execution systems still rely of paper-based processing for GxP record keeping. Pharma 4.0 means handling GxP- compliant documentation as data in new electronic formats. ◗ Merging data: GxP relevant records will increasingly be defined by application, making the differentiation between GxP or non-GxP less relevant and requiring greater security for nonGxP areas. ◗ Global collaboration: The goal is to free content and data from company silos to allow them to

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be securely shared among virtual teams that can be quickly changed and reconfigured.

Dividella modular and digitised solutions Dividella presented several Pharma 4.0 solutions at Interpack 2017 in Dusseldorf. Smart device: A Dividella NeoTOP x TopLoad syringe packaging machine was controlled and monitored remotely via a Smart Device. With the aid of the device, multiple production units can be scheduled, coordinated and controlled in parallel. The solution, based on HTLM 5, is compatible with all systems and mobile terminals. Condition monitoring and predictive analytics: Dividella also presented a prototype solution for remote monitoring status of the NeoTOP x, using data captured in real time and applying algorithms to generate forecasts in which critical changes are predicted/detected and corrective interventions scheduled before failures occur. Smart packaging: Product personalisation and product security can be taken to new levels using smart communication of the pack with the patient and communication with the machines in the production process. In addition to the actual product, consumers can request additional services via the package, which also communicates with the packaging machine to control settings for individual, personalised products. These solutions

use NFC chip technology developed by Rondo. Plug and produce: Vertical integration (creation of a standardized interface between production machines and control system) is fundamental in implementing Pharma 4.0 solutions. Plug & Produce, developed by Werum, is like connecting USB devices, making it possible to â&#x20AC;&#x2DC;plug and playâ&#x20AC;&#x2122; systems or packaging machines within the overall networked system. Enterprise Manufacturing Intelligence (EMI): EMI can improve product quality (process stability) and productivity (process efficiency) by supervising production almost in real time. Processes can be continuously verified applying production data to support decision-making. The customer can make better-informed decisions on process stability and process efficiency, to enhance both quality and productivity. ACE Technologies is the official representative of Dividella (KORBER Group) in India. Contact acetechnologies@vsnl.net for more information.

Contact details ACE Technologies 223, Blue Rose Industrial Premises CHSL, Western Express Highway, Opp Magathane Bus Depot, Borivali ( E ), Mumbai Phone: +91-22- 42089270 E-Mail: acetechnologies@vsnl.net

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PHARMA ALLY VALUE ADD

Anaytical detection in HP-TLC Prashant Hande, Lab Manager, Anchrom, gives an insight on how HP-TLC techniques offer numerous possibilities of detection

TRADITIONAL methods of detection, identification and quantification in HP-TLC are based on image documentation, scanning densitometry in UV absorbance and fluorescence, spectra recording and post chromatography derivatisation (PCD), as seen in earlier issue. In HP-TLC, the chromatographed sample is retained by the layer, which is amenable for further analysis. By using multiple techniques, several 'chromatograms' are obtained from each sample. After chromatographic separation, it is possible to generate as many as 15 'chromatograms' by instrumental analysis (image documentation and scanning, both before and after PCD) and by bio-activity studies. HP-TLC plate, with multiple chromatograms of same sample, can be cut (!) and each 'piece' evaluated by a different detection mode to get different information about the sample. Thatâ&#x20AC;&#x2122;s a truck load of data, from just one 'physical' chromatogram, useful for QC as well as R&D! All this without repeating chromatography!! Studies on molecules as potential new drug candidates are done on a micro or nanoscale. HP-TLC plates usually contain enough amount of un-

42 EXPRESS PHARMA February 1-15, 2018

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CAMAG, SWITZERLAND HP-TLC SYSTEMS Camag with instruments and E. Merck with pre-coated plates led the world from TLC to instrumental TLC. In 2015, USP introduced the SOP for HP-TLC. Ever since then most pharmacopoeias in the world have adopted this SOP. HP-TLC is a stepwise procedure. It uses one instrument per step. A series of instruments controlled by a common software make a HP-TLC System. It is GLP compliant and suitable for IQ-OQ and 21CFR 11 compliance.

Typical Configuration of Entry Level HP-TLC System Vision

CATS

HP-TLC software

Mass spectrometric detection is very widely used in chromatography, including HP-TLC. The ‘physical chromatogram’ is available on the plate and using an elution interface; the desired fraction(s) can be eluted and fed to a MS online known substances or a group of substances for in-situ bio-studies. If a separated 'fraction' shows promise, that fraction may be further resolved by 2-D HP-TLC into more fractions for the same study. This narrows down the molecules with potential, within a day or two for further studies by MS, IR, NMR etc. Using 2mm thick layers, it is possible to isolate sufficient amounts of a pure substance. In PCD, the plate is sprayed with the derivatisation reagent and heated to complete the reaction. However, for bioassays, heating is usually not necessary. Here the suitably cut part of the plate is immersed in the reagent or a solution containing live organisms like bacteria or fungus. Then it is straight forward to observe the results, usually with naked eye. Mass spectrometric detection is very widely used in chromatography, including HP-TLC. The ‘physical chromatogram’ is available on the plate and using an elution interface; the desired fraction(s) can be eluted and fed to a MS online. Such a cycle of band location and elution in to MS & obtaining m/z values takes 3-4 min. The interface is an ideal, very highly productive, off-line accessory for an existing LC-MS or a LC-MSMS. Many R & D labs abroad have a standalone MS with TLC/HP-TLC MS interface as common facility. As many as 70-80 mass spectra of selected fractions can be obtained in a day. The days of monitoring reactions by TLC and then wait for MS from LC-MS in next

Sample Applicator

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two to three days are history. SAMPLE APPLICATION

Some of the common bio-detection techniques in HP-TLC are as follows: Toxicity study – Vibrio Fischeri is a bioluminescent bacterium. It is also very weak and easily killed in the presence of even mildly toxic substances. The plate is dipped in a solution containing V. fischeri & kept inside a completely dark chamber, mounted with a cooled, long exposure camera. The dark bands are observed where the bacteria die due to absence of luminescence. The test is practically instant, a very big advantage in drug discovery. Anti-oxidant study – The chromatographed plate is dipped in a DPPH solution. Anti-oxidant fractions appear light on a dark background. Effect directed analysis - It has been reported for estrogens, seed oils, insecticides Anti-bacterial or Anti-fungal study – The chromatographed plate is similarly dipped in a suitable medium containing appropriate fungus or bacteria. Those fractions that have “anti” properties are evident due to zones of inhibition, against the normal growth all over the plate. In conclusion, it can be said that preservation of ‘chromatogram’ is unique to HP-TLC. This allows multiple progressive detection of fractions by non-destructive and destructive detection modes.

Auto Sampler

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CHROMATOGRAM DEVELOPMENT

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21CFR 11 MADE

For live demo, details & free training at our India-specific HP-TLC Applications Research Lab:

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hptlc@anchrom.in 9833830899

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B&R Innovation Day2018: Automate · IIoTize · Deliver The fourth edition of B&R’s flagship annual event had over 200 guests from factory operators, machine builders and industry experts INNOVATION DAY is a B&R conference on trendsetting automation technologies, which was recently held in Pune. The fourth edition of B&R’s flagship annual event had over 200 guests from factory operators, machine builders and industry experts to deliberate on innovations for manufacturing and Industrial IoT. Through focussed presentations and live demos, B&R displayed innovative automation solutions for smart machines and factories for successful Industrial IoT & Industry 4.0 implementation. B&R is a technology leader in industrial automation, and Innovation Day serves as a platform for launching innovative solutions in India. This helps machine builders to cost-effectively adopt new technologies, be globally competent and ready for the future. “With the acquisition of B&R by ABB in July 2017, B&R Austria has become the new global centre for machine & factory automation for the ABB Group,” says Jhankar Dutta, MD, B&R India. B&R remains an independent business unit and own legal entity, with the B&R brand name and cultural identity continuing to remain. B&R also keeps its focus on continuous growth. “We are expanding our office space to 16000 sq ft in Pune at the same time investing on manpower across India to match our growth plan of doubling business volumes in coming three years,” quotes Jhankar. “B&R is known for providing best-inclass service to customers and today we take customer service to the next level by launching a world class customer support initiative with a dedicated hotline.” Jhankar speaking on the theme of Innovation Day 2018, ‘Automate · IIoTize · Deliver’, provided a glimpse of many innovations to be launched dur-

44 EXPRESS PHARMA February 1-15, 2018

tive solution that makes it easier than ever to perform advanced analytics on brownfield manufacturing assets. B&R’s Orange Box lets users access previously unreadable energy and process data from digitally isolated machinery. The Orange Box is able to read data from the machine without any changes to existing hardware or software. Clearly visualised performance metrics make it easy to identify opportunities for targeted improvement so machinery can be operated more efficiently. As an Industrial IoT solution package, the Orange Box brings smart-factory intelligence to brownfield installations.

Jhankar Dutta, Managing Director, B&R Industrial Automation

ing this event with a few notable ones highlighted below.

ACOPOStrak: Enabling the batch of one Customers demand for individualised products is increasing, and manufacturers are constantly working towards satisfying these ever rising needs. Customisation is only possible with highly automated factories, however, and they are moving from mass production to batchof-one. In order to be profitable, factories face the dilemma of producing single units with the same economy as bulk production. Retooling a manufacturing system to achieve individualisation seems to be a cost-prohibitive endeavour. To answer these market demands and achieve mass customisation cost effectively, B&R has introduced ACOPOStrak. It is a revolution in adaptive manufacturing that helps extend the economy of mass production down to batches of one. In the case of a bottling plant, ACOPOStrak enables beverages of different flavours and sizes to be filled, labelled and capped on a single production line – with zero downtime for changeover. ACOPOStrak opens up new di-

mensions of resource efficiency. It boosts the quality factor of overall equipment effectiveness (OEE), multiplies return on investment (ROI) and accelerates time to market (TTM).

Machine vision: Intelligent and integrated Vision technology ensures better quality and flexible production in modern manufacturing facilities. Conventional machine vision systems rely on a separate controller and camera systems that communicate with the machine controller over either I/O channels or a communication network. This approach is not real time and adds a significant amount of programming to developers’ workload. It also increases the amount of integration work for machine builders and adds enormous costs. Previously existing in two separate worlds, machine automation and machine vision now come together seamlessly in B&R’s new fully integrated solution that requires no special engineering tools and no extra programming languages. Like all of its automation products, B&R’s machine vision system is programmed using the ready-

made components of mapp Technology. The resulting application covers everything from process control and motion to machine vision and HMI. The first fully integrated machine vision system opens up a world of new opportunities for machinery and equipment manufacturers by allowing them to implement both control and machine vision tasks with a single tool.

Orange Box: Industrial IoT for brownfields A greenfield site is a blank slate, where new technologies for smart machines and factories can be implemented with relative ease. For brownfield machines and factories that have been operational for decades, the task is much more difficult. The challenge is to establish sufficient communication to retrieve production data. Tracking energy consumption and optimising the efficiency of processes and maintenance tasks are important factors, especially for small and mediumsized companies, yet machines cannot simply be replaced year after year to keep pace with technology trends. B&R now offers a cost effec-

Open communication standards A typical factory relies on machines from different vendors that use a variety communication protocols. This makes horizontal (machine-to-machine) and vertical (machine-to-cloud) connectivity a distant dream. Industry 4.0 and Industrial IoT demand open interfaces and open communication standards. Consistently at the forefront of technology, B&R has always been a pioneer of open communication technologies. Open standards are essential for the success of Industry 4.0. B&R systems are based on open source, vendor-independent standards such as OPC UA, Ethernet POWERLINK and openSAFETY. Ethernet POWERLINK provides real-time, deterministic communication down to 100 µs for machine automation. OPC UA acts as a backbone for machine-to-machine and machine-to-cloud connectivity with all the necessary security mechanisms in place. openSAFETY is the only open, fieldbus-independent safety protocol enabling safe communication from the sensor to the process layer.

PHARMA ALLY VALUE ADD

Biological indicators and the United States Pharmacopeia Kurt McCauley, Director of R&D and Support Services, Mesa Labs and Nicole Robichaud, Scientific and Technical Service Representative, Mesa Labs, give an insight on recent revision of the USP which contains significant changes pertaining to biological indicators MESA LABS manufactures its biological indicators (BIs) in accordance with several standards. In a previous edition of Spore News, we discussed the AAMI/ISO standards which pertain to BIs manufactured for the medical device industry (Spore News Vol 12, no 1). This edition covers BIs manufactured for use in the pharmaceutical industry as detailed in the United States Pharmacopeia (USP). As is the case with any standard that is designed to remain relevant, the USP undergoes periodic revisions. The most recent revision of the USP contains significant changes pertaining to biological indicators and their use in the industry and these will be discussed in this Spore News edition.

A brief history of the USP The USP was established on January 1, 1820, in the senate chamber of the US capital building. Its purpose was to create a compendium of therapeutic products and provide recipes for their preparation. A comprehensive timeline of changes to the organisation can be found on the USP website1, however, a few dates of interest include: 1 1830 - a Committee of Revision was created and the USP is revised at 10-year intervals. 2 1900 - USP incorporated as a not-for-profit corporation and the Board of Trustees is created. 3 1938 - The Federal Food, Drug, and Cosmetic Act passed and the USP is recog-

APPENDIX 1. COMPARISON OF CURRENT REVISION OF CHAPTER <55> TO DELETED ENFORCEABLE CHAPTERS Subject

Pre-August 1, 2016 Version

Post August 1, 2016 Version

Population – Number of Samples

Chapter <55> • three specimens

Chapter <55>• manufacturer must use “at least four test samples”

Population - method

Chapter <55> • blender cup method

Chapter <55>• does not specify method, only states to “mechanically disrupt to achieve a homogeneous suspension”

Population – test tube size

Chapter <55> • screw capped 16 x 125 mm

• Not specified

Population – acceptable range for verification of labeled population

USP Monographs• For paper carriers and selfcontained: “log average number of viable spores per carrier is not less than 0.3 log of the labelled spore count per carrier and does not exceed the log labelled spore count per carrier by 0.48”• For nonpaper carriers: “the average number of viable spores per carrier are within -50% and +300 per cent of the labelled count per carrier”• For liquid spore suspensions: “within ±1 log of the value stipulated by the manufacturer”

Chapter <55> • For vendor supplied BIs: “between 50% and 300% of the manufacturer’s stated value”• For spore Suspensions,“within 50% 300% of the labeled count”

Population – plate counts

Chapter <55>• “preferably 30 to 300 colonies, but not less than 6, on each of a pair of plates”.

Chapter <55>• “30 to 300 colonies on each plate in a pair”.

D-value – Number of Samples

Chapter <55>• “Take a sufficient number of groups of specimens of biological indicators in their original individual containers, each group consisting of 5 to 10 specimens.”

Chapter <55>• “Use 20 replicate test sample BIs in their original individual containers, subjected to at least five exposure conditions for a total of 100 tests.”

D-value – Verification

Official Monographs• “The requirement of the test are met if the determined D value is within 20 per cent of the labelled D value…”

Chapter <55>• Not specified in this chapter

Purity

Official Monographs• “Purity: By examination of the colonies derived from the spores on a suitable plate culture medium, determine that there is no evidence of contamination with other microorganisms.”

Chapter <55>• Not specified in this chapter

Survival/Kill

Official Monographs• Equations for calculation of Survival and Kill times• Acceptance criteria• Retest procedure if not more than one BI fails the procedure described in Chapter <55>Chapter <55>• Procedure for verification of values per the equations presented in the official monographs

Chapter <55>• “. . . should be provided by the manufacturer and verified by the end user.”

nized as official and is enforced by the FDA. 4 1942 - The USP revision cycle is changed from every

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10 years to every five years. 5 2002 - The USP is revised and published annually. Revisions now occur con-

tinuously and are presented annually in the USP and twiceannually as Supplements to the USP.

USP Structure The USP is organised into numerous chapters. General chapters numbered 1 to 999

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PHARMA ALLY (i.e. monographs) are considered 'enforceable' whereas general chapters numbered greater than 1000 are for informational purposes only. In the current USP revision, BI content is predominantly in chapters <55> “Biological Indicators—Resistance Performance Tests” and <1229.5> Biological Indicators for Sterilization”, although most chapters in the <1229> series also contain BI references.

APPENDIX 2. COMPARISON OF CURRENT INFORMATIONAL CHAPTER <1229> TO DELETED CHAPTER <1035> Heading

General Chapter <1035>Biological Indicators for Sterilization

General Chapter <1229.5>Biological Indicators for Sterilization

Introduction/Proper Use of Biological Indicators

• General description of a BI, the organisms used for BIs and the applications of BIs

• General description of a BI, the organisms used for BIs and the applications of BIs

BI Manufacturer’s Responsibility

To provide:• Certificate of Analysis • Microbial count and resistance stability throughout shelflife • D-value and method by which it was determined • Storage conditions • Directions for use, including medium and conditions used for recovery • Disposal instructions

To provide: • Certificate of Analysis • Microbial population • Resistance (D and Z values where appropriate) • Storage conditions • Expiry • Directions for use, including medium and conditions used for recovery • Disposal instructions

BI User’s responsibility

• Should establish suitability for use in a specific sterilization process • Should establish in-house acceptance standards for BIs • Should obtain a Certificate of Performance • Should perform audits of manufacturer • Should verify purity and morphology • Microbial count should be determined • Manufacturer’s D-value range, storage conditions, expiration and stability should be observed

• Suitability for use in a specific sterilisation process must be established • Should obtain a certificate of analysis • Should verify labelled population • Resistance need not be reconfirmed when used according to manufacturer’s directions

User-prepared biological indicators

• Users responsibility to ensure performance requirements met.

• Users responsibility to determine population and resistance.

Characterisation of biological indicators

• Information located throughout various sections.

End user acceptance and control of BIs • Packaging and Storage • Expiration Date • Identification • Purity • Disposal

Types of biological indicators

General descriptions • Spores inoculated onto a carrier in a package • Spore suspension inoculated onto or into product • Self-contained, growth medium in direct contact with spores during sterilisation • Self-contained, growth medium placed in direct contact with spores after sterilisation

General descriptions • Spores inoculated onto a carrier in a package • Spore suspension inoculated onto or into product • Self-contained, growth medium in direct contact with spores during sterilisation • Self-contained, growth medium placed in direct contact with spores after sterilisation

Selection for a specific process

• Gives general description sterilisation modalities, appropriate test organisms, and their typical resistance characteristics.

• Gives general description of sterilisation modalities, appropriate test organisms, and directs reader to USP chapters <1229.1 to 1229.11> for further information.

BIs and the USP Biological Indicators are not pharma products so why are they included in the USP? The USP mission statement, “To improve global health through public standards and related programmes that help ensure the quality, safety, and benefit of medicines and foods”, provides the answer. In short, BIs are a tool necessary for assuring the ‘quality’ and ‘safety’ of pharma products and as such, guidance for their preparation and use are included in the USP. Chapter <55>, considered enforceable, describes the methods and materials used to determine the resistance of BIs and is intended for both the manufacturer and the user. It sets tighter controls for the manufacturers on the use of replicate units per test, while stating “the end users are not required to use the same number of replicates for verification of those determinations”. A comparison of differences between the current revision and the previous version of chapter <55> is presented in Appendix 1. The most significant change is that all BI information has been deleted from the official monographs section and much of it relocated in chapter <55>. This table is not all inclusive and the reader should refer to the USP for complete details. New informational chapters to the USP are numbered in the <1229> series and largely replace the deleted chapter <1035> “Biological Indicators for

46 EXPRESS PHARMA February 1-15, 2018

BIs are a tool necessary for assuring the ‘quality’ and ‘safety’ of pharma products and as such, guidance for their preparation and use are included in the USP

Sterilization”. This series provides a well written and easy to understand description of the basic principles for control of a sterilization process including, process development, process validation, and maintenance/monitoring. As Biological Indicators are tools that are used in each of these steps, they are discussed throughout most of the <1229> series which include: ◗ <1229> Sterilisation of Compendial Articles ◗ <1229.1> Steam Sterilisation by Direct Contact ◗ <1229.2> Moist Heat Sterilisation of Aqueous Liquids ◗ <1229.3> Monitoring of Bioburden ◗ <1229.4> Sterilisation Filtration of Liquids

◗ <1229.5> Biological Indicators for Sterilisation ◗ <1229.6> Liquid Phase Sterilisation ◗ <1229.7> Gaseous Sterilisation ◗ <1229.8> Dry Heat Sterilisation ◗ <1229.9> Physicochemical Integrators and Indicators for Sterilisation ◗ <1229.10> Radiation Sterilisation ◗ <1229.11> Vapor Phase Sterilisation ◗ <1229.12> New Sterilisation methods A comparison between the <1229> chapters and the deleted chapter <1035> is presented in Appendix 2. This table is not all inclusive and the reader should refer to the USP for complete details.

Discussion It is our opinion that the latest revision of the USP provides significant improvements in both its organisation and presentation of the biological indicator subject matter. Some of the values previously presented in the general information chapter (e.g. the Dvalue ranges in chapter <1035>) were interpreted by many firms to be enforceable, and as such caused some confusion. These have been removed in the latest revision. Additionally, the USP increasingly references existing standards that meet their expectations (e.g. ISO 11138 series-Biological Indicators, and ISO 18472-Resistometers), rather than create a redundant set of standards.

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Label serialisation: Choosing the correct coding technologyfor US DSCSAcompliances Sandeep Vadakattu, Deputy General Manager - Life Sciences Sector, Domino Printech India, gives an insight on selecting the optimum coding technology for labelling lines MEDICINES FOR the US market are predominantly packed in bottles, with statutory information printed on labels affixed to these bottles. As pharmaceutical manufacturers are gearing up to meet the DSCSA (Drug Supply Chain Security Act, section 582(b)(2)(A), we have made a comprehensive study to help the industry in choosing the most suitable and versatile technology for coding onto labels. With the implementation timeline extended till November 2018, we are certain this study will help the industry in making informed decision in selecting optimum coding technology for their labelling lines. Thermal Transfer technology (TTO), Thermal inkjet technology (TIJ) and Laser Printers are time tested and widely proven technologies for coding on different packaging materials. TTO is a ribbon based technology which enables printing of high resolution codes on flexible materials like laminates, pouches and labels. Its performance is proven in a wide range of industries

across the globe. It is essentially a contact coding technology. TIJ is an ink-based technology which has proven its performance in serialisation of millions of cartons globally. The pharma industry is grappling to choose the optimum technology for coding on labels for bottle serialisation. The coding technologies that are available for the manufacturers to serialise the labels (which will be applied to bottles) are thermal inkjets, thermal transfer printers and lasers. An informed decision will help in addressing current as well as future coding requirements. The below table provides detailed analysis of TIJ and TTO technologies with an objective of addressing the four big challenges:

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PHARMA ALLY The below table provides detailed analysis of TIJ and TTO technologies with an objective of addressing the 4 big challenges

Case study: Impact of rejection rate on operational costs ◗ To understand the impact of high rejection ratio on operational cost, we illustrated a case study below: ◗ Line speed – 150 labels per minute ◗ Rejection rate with TIJ – 2 per cent ◗ Rejection rate with Domino V230i TTO – 1 per cent (Actual reject rates are less than 1 per cent) The codes on labels are scanned using 360 degree camera scanners and bottles with defective codes are rejected. It is not just the label, but also the bottle which gets rejected. ◗ A quick glance on the poten-

tial savings which Domino V230i Thermal Transfer Over printer (TTO) can make are mentioned below:

Customised labeller bracket Domino’s labeller bracket provides great operator experience with flexibility of changing printer position in X axis as well as Y axis, enabling flexibility to code on different sizes of labels. The printer orientation can also be changed to suit the coding window orientation of labels.

Contact details marketing@dominoindia.com or call us at +91-9599488058

Bottle label coded with Domino V230i TTO, Grade ‘A’

A quick glance on the potential savings which Domino V230i Thermal Transfer Over printer (TTO) can make are mentioned below:

Domino V230i TTO installation on Bottle labelling line

Customised labeller bracket

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LABORATORY EQUIPMENTS Laboratory Centrifuges

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Humidity Chamber with TFT Display Dry Hot Air Oven RDHO

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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. Our technology enables manufacturers and CMO’s to comply with the validation requirements of Good Manufacturing Practice (GMP) and emerging global legislative standards, such as the DQSA, helping to secure the supply chain from Product to Pallet.

Trust the experts. Contact Domino to discuss your serialization

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

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Leading Nirtogen Plant manufacturer for more than 30 years

Turnkey supplies to Pharma Sector and other industrial segments such as Chemical, Power, Metallurgical and Food - where we have sustained majority market share consistently and established ourselves as market leaders and amongst the largest and best-of-breed air and gas treatment systems company around the world.

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

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CONTAINED CHILSONATOR SYSTEM CCS Series Roll Compactor Also, Suitable for product which need process Isolation/ Containment

A Traditional of innovation in Particle Forming Technology for Pharmaceuticals, API, Food & Cosmetics Contained Chilsonator System CCS 220 Lab Model Ideal for R&D, Pilot plant and Small • Ultimate GMP and Process flexibility • Wide range of capacities from 50 grams to 20 kgs/hr • Fully instrumented with automated controls • Scales up to larger roll compaction • Low profiles/minimal headroom required • Process flexibility with VariousRoll Surfaces, Size reduction Rotor • Automated Controls for Consistent Product

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introduce

An Enterprise Providing Professional Value of Optimized Technology Name Source : Advantage + Technology + Praxis + Practice

From Technique for Humanity

From Zero Base to Innovation

Breakthrough the existing frame, users-centered and innovative new product

Optimized Technology

1st Indian Company to launch “CE” approaved equipment. 1st Indian Company to launch “PLC Based” Control System. 21CFR Part 11 Compliant Software

Tablet Press

Capsule Filling F Series

P Series

GSM Technology: SMS Mobile Alert. “Best Service in its Class”. Acclaimed by our Proud Customers.

Our World Class & World Renowned Equipment n

Walk-In Humidity Chambers.

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BOD Incubators.

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Humidity Chambers.

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Bacteriological Incubators.

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Walk-In Cold Chambers

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Photostability Chambers.

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Cold Chambers.

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Deep Freezers.

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Walk-In Incubators.

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Ovens.

Mack Pharmatech Pvt Ltd. B-48, Malegaon MIDC, Sinnar, Dist. Nashik, Pin - 422 113, Maharashtra, India

+91 2551230877

+91 2551230877

sales@mackpharmatech.com

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www.mackpharmatech.com

service@mackpharmatech.com

Sejong Coater

Sejong FBD

C Series

D Series

Source Genuine Sejong Spares from Allpharm Alone Save your high tech machines from Non OEM, Spurious parts

A 404, Rajeshri Accord, Teli Galli Cross Lane, Andheri (East), Mumbai - 400 069 Tel: +91 97691 99633 Email: mail@allpharm.in Web: www.allpharm.in

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OSMOMETER 3250 Pharmaceutical Applications NASAL

ORAL

TOPICAL

The One Point Source for Tamper Evident Sprayers

FEATURES u

Tamper Evident

u

u

Sterilizable

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Tablet Applicators

u

Accurate dosage delivery

u

Cream Applicators

u

Available in different dosages

u

Tablet Containers

SANTAPET POLYMERS LIMITED Office: 8 Sheriff Devji Street, 1st Floor, Mumbai - 400 003. India Tel.: +91-22-23420381 l 66151691 Fax: +91-22-23441578 Email: suraj@santapetpolymers.com l Website: www.santapetpolymers.com

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

www.kesarcontrol.com

www.kesarcontrol.com

www.kesarcontrol.com

Humidity Chamber

Cold Chamber

Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727

Mobile : 09427613646 Email : service@kesarcontrol.com

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EXPRESS PHARMA BI For Silicon / Flexible Tube Validation Is Silicon / Flexible Tubing Sterilisation Validation Is Cumbersome ? • Easy To Use • Easy To Install • No Destruction Of Tube

*Check The Efcacy Or Validation Of H2O2 / VHP Process*

S S Carrier Designed for use With Isolator / Filling Line With ATCC - 7953 / 12980

• Apex Discs • Apex Ribbons • Tri-Scale Bioligical Indicator 11X14EPAd02

For Hydrogen Peroxide

June Enterprises Pvt. Ltd. | www.june4gmp.com quality@june4gmp.com | 022-27787913

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Technical Services Most Direct Method Of Evaluating The Resistance Of Organism By Performing D- Value Study For Products & Bioburden Isolates

D-Value & Lab Testing

Is Your BI Supplier Is Audited By Regulatory Authority?

11X14EPAd01

BI Manufacturing Facility is USFDA Approved

June Enterprises Pvt. Ltd. | www.june4gmp.com quality@june4gmp.com | 022-27787913

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PHARMA LIFE AWARDS

IPAorganises awards function & fellows’dinner The function was organised on the sidelines of 69th Indian Pharmaceutical Congress hosted by the APTI

I

ndian Pharmaceutical Association recently organised awards function & fellows’ dinner at Rajiv Gandhi IT Park, Chandigarh. The function was attended by the fellows of IPA, industry leaders, regulators, educators and healthcare professionals. The function was organised on the sidelines of 69th Indian Pharmaceutical Congress hosted by the Association of Pharmaceutical Teachers of India (APTI). The programme began with an invocation and lighting of lamp by IPA President, Dr Rao Vadlamudi along with the past presidents of IPA, Prof CK Kokate, Subodh Priolkar, Prof B Suresh, Dr C Gopalakrishna Murthy and Dr JAS Giri. Dr Alka Mukne, Editor, Pharma Times performing the role of compere, welcomed the elite gathering and awardees and initiated the proceedings of the evening. Dr Vadlamudi was felicitated by the past Presidents of IPA present at the award function for getting elected as the President of Commonwealth Pharmacists Association for the term 2017-19. Dr Vadlamudi and TB Nair also felicitated Dr RN Gupta, who was the recipient of the eminent pharmacist award and Dr B Suresh, recipient of the Prof ML Khorana Memorial Lecture Award of Indian Pharmaceutical Association. Dr Suresh was also feted for receiving the Commonwealth Pharmacists Association fellowship in 2017. Dr Alka Mukne announced the IPA ACG – SciTech Innovation in Solid Dosage forms. Ajit Kanetkar and Pavan Kumar of Associated Capsules Group were invited to present the IPA ACG – SciTech Innovation Awards. Prof Kanchan Kohli, Jamia Hamdard, New Delhi was awarded the Best Innova-

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Dr Rao Vadlamudi lighting the lamp

Dr RN Gupta felicitated by TB Nair and Dr Rao Vadlamudi

Dr Rao felicitated by Past Presidents

Dr B Suresh felicitated by Dr Rao Vadlamudi

tive Development of Solid Dosage Form Award for 2017 for her work on SNEC 30: US patented SNEDDS formulation for curcumin. The award consisted of a memento and a cash reward of ` 100,000. The special recognition award in Innovative Development of Solid Dosage Form was given to Prof Padma Devrajan, Institute of Chemical Technology, Mumbai for her work on Solid Dispersion cum film technology for bio enhanced drug delivery. This award had a memento and a cash reward of `

50,000. The Best Innovative Packaging of Pharmaceutical Formulation Award was presented to Abbott Healthcare for their work on LiDoCon Metered Dosing Technology for Liquid Pharmaceuticals. The award had of a memento and a cash reward of ` 100,000. Dr Divakar Goli, Editor, IJPS, announced Prof ML Khorana IJPS Best Research Paper awards. The awardees were F Hassanzadeh, K Javidnia, K Krishnamoorthy, M Acharya, S Roy, J Liu, K Muthusamy. Dr

Vadlamudi and Dr Goli honoured the authors with a memento, certificate and a cash prize of ` 10,000. The IPA Bengal & Maharashtra State branches received the Outstanding State Branch Awards and the Outstanding Local Branch awards were bagged by the Peenya, Rajahmundry and Enikepadu Local Branches for the year 2017, respectively. The much-coveted IPA Fellowships were conferred on SV Veerramani, Atul Nasa and Dr S Vidyadhara for the year 2017.

The prestigious IPA – Ramanbhai Patel Foundation Life Time Achievement Award was presented to Prof CK Kokate for the pivotal role played in the growth of the pharmaceutical profession and pharmacy education and for his significant contribution in the activities of IPA for more than three decades. The President joined by all the IPA Past Presidents honored Kokate with a shawl, citation, medal and a cash prize of ` 25,000. EP News Bureau

For product requirement or any queries please contact: marketing.india@sciex.com

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

It’s an award winning product! You must try it!