Express Pharma (Vol.13, No.18) July 16-31, 2018 by Indian Express

VOL. 13 NO. 18 PAGES 64

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CONTENTS Vol.13 No.18 July 16-31, 2018 Chairman of the Board Viveck Goenka

REVISITING AYUSH POLICY

MARKET

Sr Vice President-BPD

The government is trying to revive the AYUSH sector, but the success of its measures would rest on its ability to establish AYUSH as an evidence-based sector | P16

Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana New Delhi

ANALYTICA ANACON INDIA, INDIA LAB EXPO TO BE HELD IN HYDERABAD

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

PHARMA LIFE

KIRAN MAZUMDARSHAW ELECTED FULL-TERM MEMBER OF THE BOARD OF TRUSTEES OF MIT, USA

LUPIN APPOINTS YASHWANT MAHADIK AS PRESIDENT – GLOBAL HR

Prathiba Raju DESIGN

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

MANAGEMENT

Prasad Tate

RESEARCH

Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team

PACKAGING SPECIAL

NOVARTIS TOUTS EFFECTIVENESS, SAFETY OF AUTOIMMUNE DRUG COPIES

TEVA TO DISCONTINUE STUDY FOR CHRONIC HEADACHE TREATMENT

ROCHE SMA DRUG SHINES IN STUDY

Sarthak Sarin, Principal Associate, Khaitan and Co

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

P28: INTERVIEW SR Shivshankar CEO, ACG Films & Foils

FOSTERING AN ECOSYSTEM FOR PHARMA PACKAGING INNOVATION

EVOLVING ROLE OF PACKAGING DEVELOPMENT TEAM IN PHARMA INDUSTRY

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

Bharat Gupta, Associate, Khaitan and Co

E-PHARMACIES IN INDIA — REGULATORY LANDSCAPE AND CHALLENGES

ADHESIVE TRACKING SYSTEMS IN PACKAGING INDUSTRY

NUMBER OF IO TRIALS IN CHINA SURGE BY MORE THAN 50 PER CENT IN 2016 AND 2017

JAPAN’S TOYO ALUMINIUM INKS JV WITH SVAM PACKAGING

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

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

BR Tipnis Manager

Express Pharma®

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

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

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EXPRESS PHARMA

July 16-31, 2018

EDITOR’S NOTE

Acing the value chain

t is ironical that a Chinese movie seems to have done what India's policy makers have been trying to do for many years: get China to lower the barriers for Made in India medicines. The movie, Dying to Survive, is being described as a 'black comedy' on how a Chinese patient with leukemia starts sourcing a cheaper version of his medicine from India and then shares this information with other patients. The film is based on the real life story of Lu Yong from China's Wuxi, Jiangsu province. He was jailed for distributing these medicines in China as they were considered counterfeit, because the Indian brands were not registered in his country. He was released when the government was faced with appeals from his fellow patients and his lawyers proved that he had not profited personally from doing this. Pharma manufacturers in India are pinning their hopes on statements from China's foreign ministry spokesperson Hua Chunying. Referring to the film, she says, “That movie is about zero tariffs imposition on anti-cancer medicines in China.” Though the statement is still vague, there is hope that this is a long awaited crack in China's stonewalling approach when it comes to opening up to imports from India, in particular IT and pharmaceuticals. Xinhua News Agency, the official state-run press agency of the People's Republic of China, also reported on July 9 that policy incentives would be be given to imports of daily consumer goods, medicine, and equipment for rehabilitation and elderly care. According to the guidelines approved and released by China's State Council, the country 'will optimize the structure of imports to support upgrading production and consumption, with tariff cuts in certain products and clean-up of unreasonable price mark-ups.' Even though vague, the remarks come after an meeting between Prime Minister Narendra Modi and President Xi Jinping during the April 28 Wuhan summit. Both countries have since reportedly stepped up negotiations for Chinese imports of Indian rice, sugar and pharmaceuticals. With the US market getting tougher, India’s policy makers will need to step up trade negotiations with countries like China and Japan, the next two biggest pharma markets, to ease the trade barriers. Thus Hua’s comments and statement will certainly cheer India's Ministry of Commerce & Industry which had recently released a research study titled, Enhancing Indian Exports of Pharmaceutical Products to China. Prepared by

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With the US market getting tougher, India’s policy makers will need to step up trade negotiations with countries like China and Japan, the next two biggest pharma markets, to ease the trade barriers

IQVIA, with inputs from Pharmexcil, the report outlines as many as 17 recommendations for Indian pharma companies to gain market access to the China market. As the report analyses, today China is the largest supplier of APIs to the west while India is the largest supplier of finished pharma products. China would like to leapfrog India and focus on biologicals and large molecules which are the hardest to make and also have the most value. As the largest manufacturer of APIs, China has a stranglehold on India's pharma companies, as they can dictate prices of these key ingredients. India's API policy has failed to get the desired results. Many API manufacturers in India are reportedly facing huge debts and are selling out. The most prominent example is Orchid Pharma (See editorial: http://www.expressbpd.com/pharma/editorsnote/lessons-from-orchid-pharmas-story/400441/) But the silver lining is that there are interested buyers for API units. Due to the strong fundamentals of the sector, larger pharma companies as well as venture capital (VC) and private equity (PE) investors are looking at APIs and pharma services as reliable bets. For example, in early July, PE firm TPG outbid peers to reportedly acquire 40 per cent stakes in Hyderabad-based Sai Life Sciences, which provides drug discovery, development and manufacturing services. At around $ 135 million, or ` 900 crore, this was a good deal for the promoters. Glenmark Pharma is also reported to be looking at hiving off and selling stakes in its API business. It reportedly is in talks with PE players like Carlyle Group, Advent International and China’s Fosun International. Meanwhile, Aurobindo Pharma is said to be in final negotiations to acquire Mallinckrodt’s specialty generics business in the US. The cherry on the cake for Aurobindo would be that the deal is at a much reduced price, thanks to pressure from the Trump administration against controlled substances. But betting on a portfolio of controlled drugs is risky, given the backlash against opioids addiction. Lupin's purchase of Gavis Pharma weighed down its balance sheet for three full years. Big bold deals are always a double edge sword, and pharma companies from India are showing a willingness to ride this sword. As the margins in generics further erode, the future is clearly in value addition.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET DEAL TRACKER

Pharma sector posts 40 deals worth $12 bn in June 2018 Private equity firms increase their investments in June 2018

he pharmaceutical industry reported 40 deals worth $12 billion in June 2018, as compared to five months average of 51 deals worth $33.4 billion. Private equity firms have increased their focus on the healthcare industry by contributing approximately $7 billion to the total deal value of $12 billion reported in June 2018. CVC Fund’s acquisition of majority stake in Recordati for $3.5 billion; CCRE Holdings’ proposed acquisition of remaining 94.9 per cent stake in China Biologic Products for $3.5 billion; and Roche’s proposed acquisition of remaining stake in Foundation Medicine for $2.4 billion were notable deals reported in June 2018. The industry reported 54 venture capital (VC) deals worth $1.6 billion in June 2018, as compared to five months average of 74 deals worth $1.9 billion. Some of the major deals in the month included I-Mab Biopharma raising $220 million in series C venture financing; Livzon Mabpharm raising $148.3 million in series A venture financing; and Freeline Therapeutics raising $117.3 million in series B financing.

Deal Date

Acquirer (s)

29-Jun-18

StepStone Group LP; PSP INVESTMENTS; CVC Capital Partners VII Recordati SpA (Italy)

3,504.6

11-Jun-18

CCRE Holdings Ltd (UK)

China Biologic Products Inc (China)

3,463.9

19-Jun-18

F. Hoffmann-La Roche Ltd (Switzerland)

Foundation Medicine Inc (US)

2,400.0

28-Jun-18

Biogen Inc (US)

Samsung Bioepis Co Ltd (South Korea)

700.0

15-Jun-18

GI Manager L.P. (US)

CBR Systems Inc (US)

530.0

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Deal value (US$ m)

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

29-Jun-18

Hony Capital Fund (HK) Limited; Ally Bridge Group; CDH Investments; EDBI Pte Ltd; Hopu Investment Management Company Limited; C-Bridge Capital Partners LLC; Hillhouse Capital Group; Shanghai Tasly Pharmaceutical Co Ltd

I-Mab Biopharma (China)

220.0

22-Jun-18

YF Pharmab Limited; Livzon International Ltd

Livzon Mabpharm Inc (China)

148.3

18-Jun-18

Syncona Limited; UCLTechnology Fund LP

Freeline Therapeutics Ltd (UK)

117.4

25-Jun-18

Invus Financial Advisors, LLC; Undisclosed Investor(s); Flagship Pioneering Inc; Fidelity Management and Research; Rock Springs Capital Management LP

Kaleido Biosciences Inc (US)

101.0

07-Jun-18

Longitude Capital Management Co LLC; CTI Life Sciences Fund L.P.;Roche Venture Fund; Abingworth LLP; Foresite Capital Management LLC; TPG Growth LLC; Frazier Healthcare Partners; Medicxi Ventures (UK) LLP; Pivotal bioVenture Partners LLC

SutroVax Inc (US)

85.0

Private Equity Firms Increase Their Investments In June 2018

Source: GlobalData

Target

Venture Capital Investments Decrease In June 2018

Source: GlobalData

PRE EVENTS

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analytica Anacon India and India Lab Expo are India’s largest and most important platform for the analysis, laboratory-technology and biotechnology market. They have the potential for more than 259 exhibitors and more than 7,714 visitors in three halls. The event will be held in Hyderabad from September 6-8, 2018. The event will focus on innovative and applied product and system solutions for laboratories in the industrial, research and science sectors. As the industry’s definitive forum, fair and conference gather all relevant informa-

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10166 0317

MARKET

CPhI & P-MEC India to be held in Delhi NCR from Dec 12-14,2018 At CPhI & P-MEC India, companies will be able to pick up on the latest trends and innovations the market has to offer UBM INDIA is all set to bring in the third edition of India Pharma Week (IPW), a week-long celebration packed with avant-garde events from December 10-14, 2018 alongside its flagship expo CPhI & P-MEC India. CPhI & P-MEC India will be held in India Expo Mart, Greater Noida, Delhi NCR Unlike the previous editions organised in Mumbai across a number of venues, this year all the engagements of the IPW, which is also South Asia’s largest pharma event will be held at the world-class venue - the India Expo Mart - Greater Noida, with all its attendant facilities. This will

enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant umbrella for an entire week. As the pharma industry is increasingly looking towards India for high quality, low cost pharma solutions, CPhI & PMEC India is the perfect event for companies to pick up on the latest trends and innovations the market has to offer. Apart from India Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress,

OPTIONS NEEDED / REQUIRED NANO TECHNOLOGY PHARMA SPECIALIST We are a well established multi-locational pharmaceutical formulation manufacturer located at Mumbai and have a well equipped R&D wing to help us keep updated with latest technologies and adopt the same to benefit our patrons. We are presently looking to assimilate the Nano-Technology for manufacture of super speciality products at our well appointed facilities. To fulfill our objective we need services of such consultancy organization who specialize in NANO TECHNOLOGIES with proven credentials in the field of Pharmaceutical preparations. Kindly respond with your interest giving details of your successfully implemented projects, key functionaries and other details as may be considered appropriate by you at.

nanotechinfo63@gmail.com 14

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plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others. The ultimate goal of all these intertwined events is to help nurture a complete pharma ecosystem in India and better enable networking with the country’s corridors of power. P-MEC India will represent the platform where international and domestic pharma experts meet to to do business, network and shape the future of the Indian and South East Asian pharmaceutical industry.

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

◗ Network and do business with over 50,000 experts from 120+ countries ◗ Grow your client range and establish new business relationships ◗ Learn about the latest trends and developments via onsite conferences, seminars, showcase rooms and more Exhibitor’s profile include analytical equipment, automation and robotics, batching systems/equipment, cleanroomequipment, filling equipment, filtration/separation/purification, health and safety products,instruments, laboratory products and equipment, machinery, packaging equipment and supplies,plant/facility equipment, process automation and controls, processing equipment, RFID, tabletting / capsule fillers, testing and measurement, validation. Express Pharma is one of the media partners for the event. EP News Bureau

PharmaLytica 2018 to be held in Hyderabad The event will be held on August 10 and 11 at the HITEX Exhibition Centre in Hyderabad PHARMALYTICA 2018 will be held on August 10 and 11 at the HITEX Exhibition Centre in Hyderabad. In the 5th edition of this international trade fair and conference, the pharmaceutical community can pick up on the latest industry trends, innovations and do business with analytical, laboratory, machinery and packaging industry. PharmaLytica conference, collocated with the exhibition is the knowledge forum and important industry gathering that will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector. PharmaLytica is evolving as the leading marketplace for products and services along the entire value chain in niche segments within the pharma industry. On Day 1, the focal theme will be ‘Quality Culture – Revolutionising Dynamics of Quality Assurance’. The

opening ceremony will have the topic ‘Challenge of Quality Culture Articulation & Development’. The sessions on Day 1 will have the following topics. These are ‘A Smart Pharma Manufacturing for Operational Excellence; Latest in Pharmaceutical, Analytical & Lab’, ‘Technology Edge’, ‘Cost-Quality Efficiency’ and Setting Quality Culture Parameters.’ On Day 2 the focal theme will be ‘Regulatory & Pricing ·A Challenge for Pharma Sector.·The sessions on Day 2 will be on ‘Is Regulatory Compliance much more than GMP?’, ‘Presentation of Case study on Pharmacoeconomics.’ A panel discussion on ‘Regulatory, Pricing & Patients ·Equilibrium,’ will be held on Day 2. Express Pharma is the media partner for the event. Supporting associations are CiPi, Pharmexcil and IDMA.

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

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

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

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

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

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

cover )

The government is trying to revive the AYUSH sector, but the success of its measures would rest on its ability to establish AYUSH as an evidence-based sector

By Usha Sharma

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THE MAIN FOCUS

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cover )

he tragedy of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) is quite unbelievable! It is one of the oldest traditional form of treatment in the world, which originated almost 500 years back in India. Post independence, it started loosing its grass root presence, which continued for many years. The irony is that since the last few decades, AYUSH is being accepted and appreciated in the west and many countries have started considering it for various treatment, however in India people are more inclined towards allopathy medicines.

How does allopathy get into a vein of Indian? The term allopathy was invented by German physician Samuel Hahnemann and was practised in America from the period of the American Revolutionary War till 1876, which marks the start of preventive medicine. If we compare origin and existence of AYUSH with Allopathy in India, we realise that the total number of experience of later method is much less and still it is ruling the planet. So, let’s understand what went wrong especially post independence? Mahesh K Vahalia, General Manager, Shree Dhootapapeshwar while criticising the allopathy pratice says, “During the british rule everything in India was looked upon as insufficient, improper, first by the Britishers and then by our Indian elite. As a result; we considered Ayurveda as an empirical system without any scientific basis and without much potential. It did not get due attention even post independence.” Like Vahalia, Dr Narendra Bhatt, Consultant Ayurveda – Research & Industry President, IASTAM – India, voice similar concerns and says, “Post-independence India adhering to British model of allopathy, now termed as

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During the british rule everything in India was looked upon as insufficient, improper, first by the britishers and then by our Indian elite. As a result; we considered ayurveda as an empirical system without any scientific basis and without much potential. It did not get due attention even post independence Mahesh K Vahalia General Manager, Shree Dhootapapeshwar

Post-independence India adhering to british model of allopathy, now termed as conventional medicine dominated medical care, lack of respect and interest by the then government for indigenous medical knowledge, added with industrialisation and urbanisation have caused limited development of ayurveda and other traditional systems Dr Narendra Bhatt, Consultant Ayurveda – Research & Industry President, IASTAM – India,

The secondary treatment accorded to AYUSH is due to historical importance given in India's healthcare policy and lack of importance given by policy makers of yesteryears. Before 2014, when AYUSH was known as Department of Indian System of Medicine, within the Ministry of Health & Family Planning, the total amount given to AYUSH in the health budget was a mere three per cent Shashank Sandu Director, Sandu Pharmaceuticals

conventional medicine dominated medical care, lack of respect and interest by the then government for indigenous medical knowledge, added with industrialisation and urbanisation have caused limited development of Ayurveda and other traditional systems. Even the late recognition from 1971 with Central Council of Indian Medicine (CCIM) Act was implemented as a copy of the IMC Act; thereby creating an unending parallel structure without rightful gains for indigenous knowledge.” There are more reasons to this. Vahalia points outs, “The original scientific scriptures are in Sanskrit which is in coded form and a strong willingness is required to learn age-old science coupled with a comparatively higher level intellect, grasping ability and memory is a pre-requisite to understand and assimilate the knowledge of Ayurveda. This dedication seems to be lacking. This may be another contributory factor.” Though AYUSH took a back-seat soon after independence, experts of AYUSH were playing as a rear wind shield and alerting about its adverse effects. Many vedic experts continued following the treatment methods and tried to educate the masses about the benefits of AYUSH. The situation would have been far better if both the government and the corporate had come together to take care of AYUSH Bhatt emphasises, “Several decades have been utilised to run after an aimless race without any major gains except creating a huge but qualitatively poor infrastructure that is less confident and less productive in terms of actual contribution to national healthcare delivery. Whereas opportunities for AYUSH have increased in recent times the AYUSH systems need to gear up to take on present day challenges.” AYUSH being the second choice of treatment method, Shashank Sandu, Director, Sandu Pharmaceuticals

( stresses, “The secondary treatment accorded to AYUSH is due to historical importance given in India's healthcare policy and lack of importance given by policy makers of yesteryears. Before 2014, when AYUSH was known as Department of Indian System of Medicine, within the Ministry of Health & Family Planning, the total amount given to AYUSH in the health budget was a mere three per cent. How can you expect the AYUSH system to grow when the government of the day did give 'RAJASHARAY'?”

Birth of AYUSH Ministry The Ministry of AYUSH was formed in 2014, under the leadership of our Prime Minister Narendra Modi. Being a

Many vedic experts continued with the practice and tried to educate the masses about the benefits of AYUSH newly formed ministry, the ministry implemented policy changes and Niti Aayog was set up. The government wanted to have public debate and opinions from all stakeholders which are spread across India and in more than six lakhs villages. Sandu, while informing the hardships taken at the ministerial level, to procure an equal status for AYUSH says, “The Ministry has been holding participative workshops of stakeholders in across India, where vaidyas, practitioners, professors, teachers, researchers as well as traditional healers are involved. This is a igantic exercise and

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will take time, but this "VICHAR MANTHAN" will certainly bring out a well laid out policy document for AYUSH.” Bhatt too appreciates the steps taken by the present

government in uplifting the status of AYUSH. Bhatt remarks, “It is appreciable that the Modi government is committed to promote AYUSH. It has initiated good steps. However, it is a challenge to deal

THE MAIN FOCUS

with the imitative and poorly defined structure that has developed over the last many decades. The inherited structure of administration is more feudal in its approach and action. It has failed to recognise

and evolve dynamic open and truly consultative mechanism driven by specific national goals.” For over a long period of time, we have heared and experienced the side effects of

cover ) allopathy medication, whereas AYUSH has minimal adverse effects. Now seeing the growing rates of chronic health diseases, people are willing to switch their medication from modern to age old practices. And the trend is not limiting to India, it has been seen across the globe. Informing about the global perspective, Vahalia says, “People are concerned about escalating cost and side/adverse effects of chemicalbased drugs. Traditional systems have been relegated to play secondary role in their countries of origin. However, Complementary and Alternative Medicine (TCAM) has the potential to play an important role in healthcare. It needs to be validated to gain useful role. Its potential has to be objectively evaluated and just as risk benefit analysis of drugs with serious side effects is done with chemical-based drugs, it has to be done with TCAM. Then we may be able to realise the benefits of ancient wisdom.” Sandu while putting forth people's concern about the adverse effects of chemicalbased drugs and their escalating costs of conventional healthcare informs, “There is a growing awareness due the easier and factual availability of information on the internet about the adverse drugs reactions from many drugs resulting in more and more people opting for natural medication. AYUSH system offers this alternative due to their time tested existence. Many common aliments can be treated through AYUSH system. Further, Ayurveda believes in treating patient as a whole, offering holistic cure against symptomatic relief.” Traditionally, Traditional Complementary & Alternative Medicine (TCAM) is considered as a safe and reliable medication. Ayurveda and other indigenous systems when given as per their own laid down principles are much safer. This is otherwise also true because of natural origin

20 EXPRESS PHARMA July 16-31, 2018

of drugs used in these systems. However, issues of safety have come up that are required to be addressed, and should follow the practice of allopathy. Rather than responding to it in a knee jerk fashion, there is a need to have a systematic comprehensive strategic approach to define and address the safety issues related to these products. Bhatt briefs, “Quality as a concept means use of right raw material, adherence to prescribed manufacturing process and finding any wrong outcome, if the processes are changed. Deriving the right parameters for the finished products will help address these issues.”

Learnings from China There is lot more attention required to our traditional methods. It needs to adopt process of modern medication forms of practices, assuring the quality of products which is documented for a longer

purpose. We have learnings from our counterpart as well. China adopted to an integrated development model for Traditional Chinese Medicine (TCM) at least five to six decades back. It was a national strategic approach that has given results now as one observes better acceptance of TCM products both in the markets and by the scientists. Taking lessons from China, which never overlooked its home grown TCM against modern medication and set a global remark, Vahalia defines, “China never neglected its traditional system. Same importance and attention was given to TCAM as to modern medicine. It continued validating the TCAM with tools of modern science.” Bhatt emphasises, “India needs to evolve a national strategic approach rather than haphazard activities. Haphazard piecemeal activities cannot contribute much. In my view, it will be possible

to develop a three to five year plan for global acceptance of AYUSH products. We leave everything to administration which besieged with much more. There is an urgent need to evolve methods to derive a national strategic plan. Evolving an Asian Medicine agenda covering more than 60 per cent of the world population is suggested by me long back. Unfortunately, we lack any internal mechanisms that involve different segments of the sector to develop national strategies. These are left to administration which is less consistent, not outcome driven and less accountable.” Acupuncture and acupressure are not only well accepted and adopted in China but it is well known globally and widely used as well. Informing about the success and taking learnings from it, Vahalia suggests, “Chinese settled abroad continued patronising TCAM and popularised acupuncture and acupressure in foreign coun-

tries. We have to learn to respect our ancient wisdom. World has benefited from vedas and our ancient scriptures while we have neglected this treasure of knowledge that is relevant even today.”

Refraining from misleading ad campaigns Before the world recognises and accepts it whole heartedly, we need to respect and refrain from misleading ad campaigns of Ayurveda, Siddha, Unani and Homoeopathy drugs in India. Bhatt informs, “There is an extensive abuse to get benefits under the name of Ayurveda by practically all segments of the industry. Efforts are being made to restrain the misuse. Most of these are half-hearted and influenced by interested factors. I doubt, if we will really succeed in curbing the misuse. There is also need to address the issue of permitting indications at the level of licensing to avoid misinterpretations. Historically, the system has either

( imitated conventional pharmacopoeia or has been forced to follow it in a twisted way. AYUSH products need their own regulatory approach within the realms of their own principles and practices.” Vahalia informs, “We have an Act called Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954. This act regulates advertisement of all drugs including Ayurveda drugs. It lists 54 disease conditions that cannot be advertised. It includes sexual potency, cancer, diabetes, menstrual disorders, mental capacity and memory, etc. The definition of word advertisement is also quite ‘inclusive’. It may be stated here that Ayurveda has

Looking forward In the beginning of this article, we have mentioned that the current state of AYUSH would have been better if corporates and the government would have taken

efforts. It seems that government is taking steps proactively. Vahalia informs, “National Health Policy 2017 covers main streaming of AYUSH and deals with many aspects

THE MAIN FOCUS

of AYUSH systems such as education, AYUSH care in public healthcare facilities, utilisation of AYUSH manpower in health delivery, validation of AYUSH therapy, stress on research and quality,

drugs on some of the disease conditions listed in DMR (OA) Act, 1954. However, due to the provisions of the Act, ASU industry is not able to advertise this to its disadvantage. However, as with other acts, enforcement is wanting. Advertising Standards Council of India (ASCI), a voluntary body also acts as watch dog on exaggerated advertisements.” He continues, “Recently, the Ministry of AYUSH has entered into an MoU with ASCI to monitor advertisements of Ayurveda, Siddha and Unani (ASU) drugs and report misleading advertisements to AYUSH and concerned state regulatory authorities. Everything said and done, self-regulation is the best regulation.”

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July 16-31, 2018

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MANAGEMENT

E-pharmacies in India â&#x20AC;&#x201D; Regulatory landscape and challenges Sarthak Sarin (Principal Associate) and Bharat Gupta (Associate), Khaitan & Co, give an insight on the need for better regulations for governing e-pharmacies

he e-commerce sector has grown exponentially over the last decade and has revolutionised the interplay between Internet and commerce worldwide. The growing infiltration of Internet and mobile phones coupled with the intrinsic convenience to indulge in retail activities online indicates that this sector is not only unrelentingly expanding in developed countries but is also contagiously spreading to developing geographies and markets as well. India is not aloof from this unprecedented growth story. While online travel and ticketing continues to be the predominant driving force behind the growth of this industry in India, the online market for the sale of pharmaceutical drugs in India has (of late) stimulated considerable attention and investments. However, given the sensitive nature of the pharmacy business and the overwhelming layers of the compliance obligations that engulf the various aspects of the sale and storage of pharmaceutical products; the rise of e-pharmacy activities in India has unfortunately been viewed with suspicion by the local regulatory authorities and consequently has been marred by controversies. At the same time, the legal developments in this sector have not kept pace with this new business enterprise and its appears that the existing legal regime (which had been enacted keeping in view the traditional brick and mortar pharmacies) is inadequate to govern e-pharmacies. Some of the key challenges and concerns that arise from the application of the existing legal regime to epharmacies are as follows: 1. The license obtained by a pharmacy is pegged to a physical store from where the sale is

EXPRESS PHARMA

July 16-31, 2018

Sarthak Sarin, Principal Associate, Khaitan and Co

proposed to take place and/or where the medicines are proposed to be stored, which physical store is required to meet the prescribed standards of hygiene, temperature control etc. However, as opposed to a sale from a brick-and-mortar store, in case of an online sale of medicines, it is very difficult to ensure that the medicines are being delivered/sold from the same licensed premises, as the consumer is not physically present to verify this. This in turn raises concerns as to the conditions of the place wherein the medicines could be stocked by an e-pharmacy to manage costs. 2. There is also a risk of the same medical prescription being used multiple times for procuring medicines across different e-pharmacies or medical stores. This is especially a red flag in case of narcotic and psychotropic drugs, tranquilizers, habit forming drugs and Schedule X drugs.

Bharat Gupta, Associate, Khaitan and Co

The rise of epharmacy activities in India has unfortunately been viewed with suspicion by the local regulatory authorities and consequently has been marred by controversies

3. Drug sale is regulated by state licensing authorities, which framework is feasible for brick-and-mortar stores, given that they are expected to be approached by the consumers who reside within the vicinity of the location of the stores (and hence within state borders). However, such a model of regulation may not be feasible for e-pharmacies since an online marketplace is accessible from any location or state, without there being any checks or control on cross border sales etc. 4. As e-pharmacies rely upon a home delivery model, there is a possibility of pilferage, loss of potency and degradation of drugs and medicines during transportation to the consumerâ&#x20AC;&#x2122;s house, especially if they are being transported over long distances or are of certain specification that requires safe handling, cold storage etc. 5. Given the absence of any physical interface between the consumer and a pharmacist,

concerns arise in relation to the process of compounding, preparation, mixing or dispensation of drugs by a pharmacist as the customer has no way of verifying if such activities have been carried out by licensed pharmacist and /or have been done as per the prescription. With the absence of an apposite legal framework coupled with an effective monitoring and enforcement mechanism, neither are e-pharmacies able to secure their footing in the market nor are the consumers fully confident of purchasing medicines online. This has led to e-pharmacies offering deep discounts on their merchandise just to make themselves visible in the market, which practice in turn has triggered an antagonistic response on part of brick-and-mortar pharmacies. Given these state of affairs, while the regulator had on 30 December 2015 clarified that there was no restriction on the online sale of medicines provided that such sale complied with the existing legal regime, no constructive steps have yet been taken by the government to address the concerns highlighted herein. Nevertheless, the recent news reports suggest that the government will soon be formulating regulations for governing e-pharmacies. It will be interesting to see how these regulations will address the challenges engulfing this new business enterprise, while balancing the interests between e-pharmacies and the traditional brick and mortar pharmacies. [The contents of this document do not necessarily reflect the views/position of Khaitan & Co but remain solely those of the author(s)]

Number of IO trials in China surge by more than 50 per cent in 2016 and 2017 GlobalData identified 819 clinical trials that have been initiated in the last 10 years (2008-17) to investigate I/O drug candidates IN RECENT years, China increased its focus on the clinical trial investigation of immuno-oncology (I/O) drug candidates. The number of clinical trials recorded a compound annual growth rate (CAGR) of ~34 per cent since 2008, according to leading data and analytics company GlobalData. GlobalData identified 819 clinical trials that have been initiated in the last 10 years (2008-17) to investigate I/O drug candidates. More than half (n=464) of these trials were initiated in 2016 and 2017. Phase II clinical trials accounted for nearly 28 per cent of the total clinical trials conducted in China, followed by Phase I (24 per cent) and Phase I/II (24 per cent). In the I/O clinical trials, 67 per cent of the trials were in progress, 24 per cent were completed and 5 per cent were planned. Out of these completed trials, 51 per cent were reported with results. FUDA Cancer Hospital is the major non-industry player investigating I/O drug candidates in China. The other top non-industry sponsors were China PLA General Hospital, Sun Yat-sen University. Jiangsu Chia-tai Tianqing Pharmaceutical Co emerged as the top industry sponsor. Other top industry sponsors were Bristol-Myers Squibb Co, F Hoffmann-La Roche and Novartis. The major indications under investigation include Non-Small Cell Lung Cancer, Solid Tumor, Hepatocellular Carcinoma, Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia), and breast cancer, etc. The top five I/O drug candidates investigated in the clinical trials that were started in recent years (2016-17) include Cellular Immunotherapy for Oncology, tucidinostat, SHR-1210, nivolumab and anlotinib hydrochloride. EP News Bureau

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July 16-31, 2018

MANAGEMENT

A pill is more than just a pill Is a pill, just a pill? Most definitely not. In the second of a series of six articles, Organisation of Pharmaceutical Producers of India (OPPI) launches the Know Your Pill initiative, to educate patients on the untold story of the medicine and the intrinsic value of quality that make a pill much more than just a pill

on’t we all remember the bitter taste that medicines left in our mouth? A paracetamol tablet to manage a fever or dull the pain of a sprained ankle, an antacid to take care of burns in the stomach or an antibiotic to treat an infection. These are all recollections that we own. How many of us are aware of the complex journey of the tablet as we take it? Is there a curiosity in us as to how this medicine would behave in our metabolic systems after we take it? Will it be destroyed by the strong acidic juices of the stomach? Or will the liver enzymes digest them long before they can reach that painful knee? There have been examples of people with a weak liver or kidney where an everyday vitamin or painkiller can be dangerous. Unsupervised consumption of painkillers has also led to chronic kidney/liver diseases in many instances. Pharmaceutical manufacturers follow a science known as pharmacokinetics, that is the ability to track the movements of a medicine after it enters the human body. They ensure that medicines reach the site of intended action in adequate quantities and stay in the blood stream for an intended amount of time. Some tablets such as vitamins are coated with a sugary syrup to mask the unfavourable taste, while others such as powerful painkillers are designed so that the actual chemical is released gradually over several hours. Doctors often issue special instructions like – don’t take a strong painkiller on an empty stomach, take a sugar-control pill half an hour before your meal, while an antacid must be taken after a meal! These

24 EXPRESS PHARMA July 16-31, 2018

instructions should be followed meticulously as the pill is manufactured to deliver an intended effectiveness under certain conditions. Certain other medicines are designed as ‘sustained release’ or ‘delayed release formulations’, which means they are either released gradually into the blood stream or within a short interval of consumption. The former technology is used for short-action chemicals, which lose their effectiveness after a few hours; but when administered through a sustained release formulation, their effect can be extended by a couple of hours. To illustrate further, delayed release products are often used for medicines that need protection from the highly acidic

ambience of the stomach. These drugs are covered by layers of special material which are dissolved slowly as the tablet passes through the stomach to the intestine (gut). They are then absorbed through the intestine walls to reach the bloodstream. All the above functions of the pill in the metabolic system are covered by what we call the ‘bio-availability’ of a medicine –how much of a medicine which is ingested or injected actually reaches the bloodstream, and travels to the site of action (such as a painful back, or an infected lung). The other factor that influences the effect that a medicinal product would have in the human body is: breakdown of the biochemical substance within the body, and the way it is excreted from the body. A wide range of pharma products are broken down in the liver, and then excreted through bodily functions. Because a pill is not just a pill, taking one without a doctor’s prescription and not being supervised by a doctor can be hazardous. To ensure consistent quality throughout the country, Government of India has mandated the Bioequivalence (BE) study for all drugs. To begin with, BE study has been made mandatory for category II and IV of the BCS system. Where common knowledge could drive us to taking pills out of habit, it is science behind the pill that should be driving the decision.

Issued in public interest by OPPI Watch this space for the third in the KYP series- ‘Good medicines come in quality packages’

RESEARCH UPDATES

Novartis touts effectiveness,safety of autoimmune drug copies Novartis’ generics unit Sandoz is among companies producing cheaper biosimilar copies of some of the most lucrative drugs for autoimmune diseases

ovartis touted safety and efficacy of its biosimilar copies of Johnson & Johnson’s Remicade and Amgen's Enbrel, citing a study it hopes will help convince doctors that switching from the original medicines is a viable alternative for treating autoimmune diseases.

The Swiss drugmaker said Zessly, its Remicade biosimilar, matched the original medicine for safety and efficacy at 54 weeks, including in patients who switched from the original. Switching from Enbrel to its Erelzi also did not impact efficacy and safety in patients with moderate to severe rheumatoid

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arthritis at 48 weeks, it said in a statement. Novartis’s generics unit Sandoz is among companies producing cheaper biosimilar copies of some of the most lucrative drugs for autoimmune diseases, in hopes of capturing a share of sales. But it also must convince doctors that its versions are

as effective as the original products, including for patients who switch. “It is our hope that these studies will help healthcare providers and patients have confidence that switching to Zessly or Erelzi will continue to deliver the benefits they are receiving from their existing treatment,”

said Mark Levick, who heads development of biologic drugs at Sandoz. Remicade and Enbrel each had peak sales of about $7 billion, though that have been falling as rival biosimilar makers including Novartis bring copies onto the market following patent losses. Reuters

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July 16-31, 2018

RESEARCH

Teva to discontinue study for chronic headache treatment The company plans to continue testing the drug for the treatment of episodic cluster headaches ISRAEL’S TEVA Pharmaceutical said it would discontinue a trial testing its drug for the treatment of chronic cluster headache, after an analysis showed that the drug was unlikely to meet the study’s main goal. Cluster headaches occur in cyclical patterns, or clusters, and are among the most painful types of headaches. The drug, fremanezumab, is under review by the US Food and Drug Administration for prevention of migraines in adults and the company hopes to launch the drug

for the disorder as soon as mid-September. Teva, which is counting on fremanezumab to help return to growth, also plans to continue testing the drug for the treatment of episodic cluster headaches. “While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine,” said Tushar Shah, Senior VP, Head of global specialty clinical development, Teva. Reuters

New research points to universal antibody drug for HIV Scientists in Hong Kong say they aim to bring the antibody into clinical trials within a timeframe of three to five years A TEAM of AIDS researchers in Hong Kong says its new research, tested on mice, indicates a functional cure for HIV, the virus that causes AIDS, eventually leading to a new antibody that could be used for both prevention and treatment. The findings, published in the Journal of Clinical Investigation, come as China faces a growing epidemic among high-risk groups, such as sex workers and men who have sex with men. The UN-supported AIDS Data Hub says about 850,000 people in China are infected with HIV, which disables the immune system and makes people far more vulnerable to infections and disease. A team led by Professor Chen Zhiwei at Hong Kong University’s AIDS Institute says its discovery, tested on mice, shows the new antibody can help control the virus and eliminate infected cells. The antibody would be able to treat all varieties of

26 EXPRESS PHARMA July 16-31, 2018

HIV – a first, Chen said - as there is no one vaccine to treat the many different types of HIV viruses. “For our newly discovered bispecific antibody, it works for all of them, so that’s the major difference,” Chen told

Reuters. Chen and his team say they aim to bring the antibody into clinical trials within a timeframe of three to five years. Chen said a 'functional cure' meant the virus level would be so low as to be unde-

tectable in the body, as long as patients kept taking injections of the antibody, perhaps on a quarterly basis, or less frequently. Those infected with HIV can keep the virus under control with antiretroviral drugs

that stop it from infecting new cells. However, treatments must be taken daily and do not eliminate the infected cells from the body. So the virus can still exist, and symptoms return, if patients stop taking medication properly. The new antibody would have a significantly longer half-life than current treatments, and could, for example, be administered on a quarterly basis, Chen said, making it easier than the daily treatment most HIV-infected patients face. Promising results did not mean the treatment would be readily available soon, said Andrew Chidgey, chief executive of the charity group AIDS Concern in Hong Kong. “Governments are being very slow to implement programmes here,” he added. “So just because a treatment becomes available, doesn’t mean that people will get it, or that it will have an impact.” Reuters

RESEARCH

Roche SMAdrug shines in study SMA is an often-deadly genetic neuromuscular disorder caused by a missing or defective gene that normally produces a protein needed for development of motor neurons in the spinal cord A DRUG being co-developed by Roche to treat spinal muscular atrophy (SMA) helped improve development scores in babies with the genetic disease, a study released showed, as the race heats up for therapies destined to be among the drug industry’s most expensive. PTC Therapeutics, which struck a licensing deal with Roche in 2011 for its SMA programme, said more than 90 per cent of babies with severe Type 1 SMA given the RG7916 drug achieved a greater than fourpoint increase in a test to measure their neuromuscular progress six months after treatment began.

The companies hope their medicine, also known as risdiplam, will be approved to take on rival drug Spinraza from Biogen, which sells for $750,000 for the first year of therapy and about $375,000 annually after that. Novartis is also quickly advancing in the SMA field with its $8.7 billion acquisition this year of US-based Avexis that is working on a gene therapy for the disorder. Analysts from Barclays project Novartis’s one-time treatment could run to $1.25 million per patient. “We are delighted that up to 6.5-fold increase of protein pro-

duction has translated into clinical impact for these babies,” Stuart Peltz, Chief Executive, PTC, said in a statement about the

RG7916 study, adding no babies required a tracheostomy or permanent ventilation since the study began, and no baby lost his or her ability to swallow. SMA is an often-deadly genetic neuromuscular disorder caused by a missing or defective gene that normally produces a protein needed for development of motor neurons in the spinal cord. This leads to muscle wasting. Many babies with the severest form of the disorder die, while others never stand or walk. Barclays analyst Emmanuel Papadakis expects that if Roche and PTC’s data holds up on RG7916 with regulators, it could

become a fierce competitor to Spinraza, now the only licensed SMA therapy. Cowen analysts also said they view PTC’s update as very encouraging for approval — and for competitiveness versus Spinraza, which is administered into the spine about four times a year. Roche’s and PTC’s drug is taken orally. Vas Narasimhan, CEO, Novartis also has high hopes for his own newly acquired SMA treatment, saying in April after the Swiss company bought Avexis that its gene therapy has “multi-billion dollar peak sales potential”. Reuters

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PACKAGING SPECIAL I N T E R V I E W

‘ACG is well geared up to constantly meet challenges by offering newer products’ ACG Films & Foils, recently became a complete packaging solution provider for oral solid dosage formulation with the launch of state-of-the-art lamination facility at Shirwal near Pune. In an interaction with Swati Rana, SR Shivshankar, CEO, ACG Films & Foils spoke about the facility, challenges faced by the sector and company’s future plans

Recently ACG has launched state-of-art lamination facility at Shirwal. Brief us on that. The new machine is a high precision machine with excellent process controls, ensuring the control of specification within the allowed global standards of the final product. By manufacturing the aluminium packaging laminates on this machine, ACG will be ensuring high productivity on the packing line at our customers’ end and minimal wastage and appropriate protection of end medicines as per the requirements of the end customers. The technology of the machine is lacquering, laminating or a combination of both. With the high drying temperature and installation of a special dryer, we can produce lid foils and cold form laminates with identical performance as produced by our competitors in Europe. Yet another feature of the machine is that it is a combination two of the machines and has the capability to produce converting materials with a very good performance. ACG entered this segment in 1993, how has the journey

28 EXPRESS PHARMA July 16-31, 2018

been so far? What are the challenges you came across these years? The ACG films and foils business was started in 1993. It was started as a part of the capsules business but over a period of time it has been structured as a separate legal entity. We are the pioneers in introducing moisture-barrier and oxygen-barrier films for packaging of medicine in the Indian market. The objective was to improve the shelf-life and quality of the medicines being used by the end consumers in India. Over the past 25 years, we have introduced various innovative products for safe packaging of medicines at optimum cost which has made us a global player in this business. Till 2009, our manufacturing was in the same facility as that of our capsules. In 2009, we set up this new factory for manufacturing high barrier polymer-based films. By setting up a state-of-the-art manufacturing unit in this same factory, our product range now includes aluminium foil laminates. This has made us the only manufacturer in India having the widest product basket for end-to-end solution for oral solid dosage packaging.

To reduce the number of counterfeit drugs in the market, ACG has anticounterfeit solution. Can you brief us on that and how is it different from other anti-counterfeit solutions available in the market? ACG has a special film laminate which uses holographic effect. The process of lamination is a specially designed and patented process which cannot be replicated. In addition to this, we are developing other alternatives also for anti-counterfeiting. How do you see the growth of films and foils industry in India? India is estimated to become 6th largest pharma market by 2022. The blister packing industry will grow at the rate of 6 to 7 per cent in the global markets up to 2020. We expect the growth in India to be higher than this. Usually packaging constitutes only around 2-3 per cent of the total price of the drug but packaging has a high impact on the quality of the final medicine. What are the regulatory issues / challenges faced by the sector and how ACG is dealing/ overcoming them?

The films and foils industry is constantly seeking higher quality standards required by the pharmaceutical packaging business especially all the overseas markets in which these companies operate. ACG is well geared up to constantly meet these challenges by offering newer products which cater to such needs. The sector faces challenges not just in terms of producing a technically superior product but also in meeting the constantly changing regulatory demands. Towards this, ACG acquired the ISO 15378 certification for GMP in primary packaging which is now being mandated by most global customer. All of ACGâ&#x20AC;&#x2122;s products also have a DMF TYPE III filing which is a regulatory requirement of most pharma customers who operate globally. The company also exports to major markets. How much revenue comes from exports? Are you also planning to enter new markets? The first step in this is to implement local warehousing, supply chain, manufacturing in various global markets. In parallel to have a complete product basket for high barrier packaging material which will provide protection to the medicines manufactured by our esteemed customers. We have local warehousing in China, Thailand, Indonesia and Argentina. We have local partners for converting and slitting of our jumbo rolls in Europe and the US. In Brazil, we have got local manufacturing. All the above points dovetail into our overall strategy for becoming a globally preferred supplier for films & foil. Currently, the contribution of exports to our total revenue is around 45 per cent and we are evaluating several new markets to enter. What are your further expansion plans and how are you planning to strengthen your foot print in

domestic and global markets? At this point of time where customer centricity is one of our prime objectives, we are adding operations near to our customers in the markets of Europe, the US, LATAM and in Siliguri, West Bengal, India. The strategy of films & foils is to become a global preferred supplier over the next three to five years to pharma customers in all the major overseas market including the regulated markets of Europe and the US. What are the companyâ&#x20AC;&#x2122;s future plans? Our immediate objective is to provide our customers high quality Alu laminates from this new machine. We are also introducing new innovative barrier packaging based on Alu and polymer films which will assist our customer in packaging their medicines more effectively. We have conceptualised environmental-friendly packaging products to help reduce the carbon footprint and anti-counterfeit products and once the prototype is internally validated, we will be ready for initial trials and evaluation by customers. Brief us on the products that are in pipeline of 2018-19. We are investing in a new coating line for our high barrier PVdC films which will be commissioned within the next one year. Additionally, in our Brazil plant, we will be laminating our high barrier film Aclar since we are the approved converter for this product for Honeywell USA. We will also manufacture PVdC films in the coating machine to be set up in Brazil. In the aluminium business, we will offer a whole new range of products which will cater to the demands of the pharma industry which was hitherto dependent on imports.

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swati.rana@expressindia.com

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July 16-31, 2018

PACKAGING SPECIAL

Fostering an ecosystem for pharma packaging innovation To help understand the innovation ecosystem it is useful to identify the key stakeholders, participants and contributors within the innovation ecosystem. ChandiPrasad Ravipati, Head-Packaging Development, Aurobindo Pharma, reveals more on this Biological ecosystem: Innovation ecosystem is based on the fundamental principle of any biological ecosystem. The very concept of a biological ecosystem is built by a network of interactions among organisms, and between organisms and their environment. The functional objective is energy flow from abiotic components to biotic components and vice versa operating as a unit in bringing an equilibrium state in the energy cycle. The equilibrium state is dynamic and to maintain the balance of population or nutrient exchange at specific levels. Our entire planet is covered with a variety of different, sometimes overlapping, and often interdependent ecosystems. Major global ecosystems are referred to as biomes. A tropical forest is a mid-sized ecosystem, which contains a diverse array of smaller ecosystems, and in turn connects with global ecosystems. These layers of ecosystems are in dynamic interactions with each other, and influence the equilibrium state each maintains. Innovation ecosystem: The growth factor for any economy is innovation with its multiple advantages of increasing output with same resources, an edge over competition with novel improvements in products and services. An innovation ecosystem is a network of relationships through which information and talent flow through systems of sustained value co-creation. The complex interactions between the stakeholders within the ecosystem shall function with objective to enable technology development through innovation in an equilibrium and sustainable condition and each stakeholder derive benefits from it. For a century, pharma research and development is concentrated in

30 EXPRESS PHARMA July 16-31, 2018

very few countries such as the US, Germany and some European countries and again in a few centres in those countries. Interaction with well planned networking between the government/private academia, government/private research and development organisations and industry was there in the patent era in those developed countries. It resulted in the development of efficient drugs against dreaded diseases, eradication of some and improvement in capability of controlling some. In this process, all the players have been immensely benefitted. A typical ecosystem of pharma packaging innovation involves the below mentioned four arenas which are interdependent with continuous interaction and clear goals. ◗ Public/private academia: Should establish institutes for packaging with special focus on

pharma packaging to foster skill and talent to the needs of current and future requirements. ◗ Public/private R&D institutions: In liaison with academia, should nurture the talent and encourage innovation and entrepreneurship. ◗ Packaging industry: With its own R&D and/or from the academia/R&D centers, should appoint talented and skilled personnel as required and engage the innovative concepts in materials and machinery. ◗ Pharma industry: Should interact with all the above, funding, giving inputs, rewarding and awarding small or big innovations which are implemented successfully. The innovation ecosystem comprises two distinct, but largely separated economies, i.e. the knowledge economy, which is driven by fundamental research, and the commercial

economy which is driven by the marketplace. An innovation ecosystem is said to be thriving and healthy when the resources invested in the knowledge economy are subsequently replenished by innovation induced profit increases in the commercial economy1. The transition in the economy of developed countries: Agricultural economy ➞ Industrial economy ➞ mass production economy ➞ knowledge economy. The funds and resources invested in knowledge economy contributed to wealth of these developed countries resulting in sate of art infrastructure and higher per capita income of citizens. Fostering talent required for innovation economy is a significant role of government and private sectors. Two important resources in the ecosystem are human capital includes students, faculty, research students and packaging technologists from packaging and pharma industry. Material resources such as funds, buildings, equipment and data base of knowledge. On a common platform of trust and shared vision, the representatives of the four elements in the ecosystem can interact on the following but not limited to, (a) corroborate with clear understanding of needs; (b) exchange the ideas and even resources if needed; (c) identifying patient and healthcare provider requirements; (d) innovation in materials and machinery; and (e) distribution of benefits derived from the innovations The role of each stakeholder in creating a knowledge economy is crucial. Public and private academia has to make the environment conducive with

suitable syllabus, laboratories and able teaching staff. They should select students based on their interest and passion for the packaging profession and involve experienced packaging technologists from the relevant industries in activities. Public and private R&D institutions should invest resources in building a right platform of excellence in packaging and encourage the students passed from academia and also from industry who aspire to increase their quest in the field of packaging and improve their qualification. Packaging and user industries should invest both in academia and R&D and can be on the advisory board to nurture the talent in right direction for current and future requirements. Sharing ideas in an open environment creates a common output that is greater than adding up individual collaborations of each discreet member. This definition is basically referring to the concept of synergy. When companies innovate through collaborative networks, they build value that no solo enterprise would be able to achieve by itself. These advantages of innovating through collaborative networks should be extensive to all partners included within the ecosystem, where relationships should be always on a win-win basis. To help understand the innovation ecosystem it is useful to identify the key stakeholders, participants and contributors within the innovation ecosystem. This will help to focus later discussion around the interactions and relationships at play within the ecosystem and, crucially, the engagement and interaction of innovative companies in the innovation ecosystem2. Pharma packaging, which was under cluster of R&D or Quality Control, has emerged

PACKAGING SPECIAL Pharma packaging, which was under cluster of R&D or Quality Control, has emerged as important and separate function in India for last one and half decade, thanks to export of generic products to regulated and emerging markets as important and separate function in India for last one and half decade, thanks to export of generic products to regulated and emerging markets. However, the major role played is to do with characterisation of packaging of innovator or Reference Listed Drug and exactly copying and sourcing of DMF vendors for primary packaging components. Innovation in packaging is driven mostly by overseas vendors to penetrate into market with new materials of better barrier properties and some of patient compliance. However with advancement in manufacturing technology, transportation methods and facilities few leading pharma organisations focused on innovation from procurement and packaging operation point of view. Examples: Removal of cotton/rayon/ polyester coil, change to normal closure from child-resistant closure for the bigger pack sizes which are not directly dispensed to patients, removal of medication guide replacing with electronic copy. Innovation in blister pack design to comply with child-resistance. With minimal and very informal interaction between packaging professionals the above mentioned initiatives got implemented one firm after another. The Indian pharma industry which is worth about $16 billion should take the lead in conducting conclaves to debate various aspects of innovation that can be brought into pharma packaging. Probably, the fear of competition could be the reason. But, in the open era scenario and globalisation these boundaries have to be removed. Every field of business, every part and walk of our life is influenced by Information Technology. The platform of building an ecosystem of pharma packaging or Packaging Science should be none other than the IT. The collective rich experience and challenges of more than a decade from all players can be pooled and placed in the website and this can become the continuous corroboration tool. Learning and training sessions can be held through this platform and all networking can be done through

this medium. A website or a search engine on pharma packaging innovation can be created with administrative control by authorised IT team, members from all four or more players can get registered to access the website. It should be well organised to ensure correctness of data and its usage. The data can be classified as into main categories such as academia, packaging R&D, packaging industries and user industries. Information on innovations, regulatory challenges and solutions, learning modules for new entrants and other data can be made available in this website. Even sharing the concepts, challenges and innovations in LinkedIn or LinkedIn Pulse would also increases the awareness, more and more people from other fields will be interested. Some of the examples are Open Serialization Communication Standards (SCS) ensure to connect information systems on serialisation requirements; PubMed/ Web Science on research articles on various fields of science and technology. The resources are abundant, the environment is vast and talent is plenty. The cream of packaging technocrats, industry giants in pharma and packaging industries should come to one platform to foster an ecosystem especially in investing money and resources for building few academia for creating young talent for future challenges. Fund R&D institutions on packaging excellence to make India one of the knowledge economies in the field of packaging science. In this process, all the components can be directed towards the goal of balancing business, meeting user requirements and the cycle of innovation continues. The benefits are derived by all stake holders in the ecosystem. It should be kick-started now.

References 1. What is an Innovation Ecosystem? By Deborah J. Jackson; National Science Foundation, Arlington, VA. 2. Innovation ecosystems as drivers of regional innovation â&#x20AC;&#x201C; validating the ecosystem by Meirion Thomas

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PACKAGING SPECIAL

Evolving role of packaging development team in pharma industry Jayanti Sawant, Consultant,Pharma Packaging Development, examines the transformation that is undergoing in the pharma packaging industry and explores its future path 2. Looking at bottles, right from heavy glass to light weight plastic bottles, one can identify many changes, right from glass packs to plastic bottles, to changes within the glass bottles. The adaption or transition from traditional packs to current days' pack has the following:

Not only that, but it didn’t break as easily, and it was compatible with many formulations as well. The medicines in glass, tablets as mini bulk packs were seen in PVC blisters, HDPE bottles with child resistant caps. To that end, we have seen high density polyethylene (HDPE) and polyethylene terephthalate (PET) become key to success.

Benefits galore

PACKAGING TECHNOLOGY with respect to pharma sector goes hand in hand with product development and supply chains. Its presence is felt constantly until the consumption of the drug by the patient or end-user. Hence, patient compliance is the most significant criteria of any packaging solution. The scenario in this sector is fast changing with a growing market, globalisation, evolving regulatory requirements, competition and revolutions in digital technology like artwork management softwares, track and trace, QR codes, RFID, anti-counterfeiting measures, tamper-evident measures etc. To understand the evolution and today’s scenario, it is important to review how technology has changed and evolved over time. 1. Traditional blister pack to Combipack (Refer Image 1 &2 -catering to patient compliance and product protection and ease of transportation ) The best eg. Birth control pills.)

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July 16-31, 2018

◗ Reduced transportation cost ◗ Product safety and efficacy enhanced as breakages during transit reduced drastically with light weight plastic ◗ Aesthetics of the pack for enhanced brand image ◗ Ease of handling during operations ◗ Customer compliance - ease of opening the cap of plastic bottle vs glass bottle The modern packaging industry is under huge pressure to constantly evolve to meet new environmental standards and to create products that are lighter in weight than their predecessors, meet customer compliance. This amazing transformation has taken place over years gradually and packaging technologists have played a vital role from conception of the product to commercialisation. The milk market and dairy products are a perfect example of this transformation In 1980, milk bottles were made of glass and mostly delivered to the doorstep by milkmen. From glass bottle to plastic bottles to tetra packs, the journey has been fast evolving. 3. The plastic revolution (mid-1980s and early-1990s) Plastic was perfect because it was lighter, so it could be transported easier, and it had the ability to be made even lighter still with the right technology.

Need for evolution Image 1 – PVC blister combipack

These re-engineering developments have expanded the job responsibilities of a packaging technologist. This modification took place gradually, with enormous impetus in last 10 years due to digital technology. Today, packaging technology is an independent cell. Decades ago it was a mere day to day function of QC, today it’s an active department in the industry playing vital role in all developments and acts as the centre point of coordination during all the new developments.

Functions of packaging

Image 2 -Alu /Alu blister pack

Pic used for representational purpose

Packaging performs five basic functions: 1. To protect a product from damage or contamination The product must be protected against being dropped, crushed, and the vibration it suffers during transport. The product must also be protected against the climate, including high temperatures, humidity, light and gases in the air. 2. To contain or hold the product and to avoid spillage or leakage during various stages of production and till it reaches the end user and he/she consumes it effectively. 3. To identify the product Packaging is the main way

PACKAGING SPECIAL products are advertised and identified. To the manufacturer, the package clearly identifies the product inside and it is usually the package that the customer recognises when shopping. 4. Protection during transport and ease of transport A package should be designed to make it easy to transport, move and lift. A regular shaped package (such as a cuboid) can be stacked without too much space being wasted between each package. This means that more packages can be transported in a container thereby systematising logistics and supply chain. 5. Stacking and storage The shape and form of the package determines how efficiently they can be stacked or stored in warehouses or at distributors' inventory.

Traditional milk packs

Tetra pack - Reality today

Categories of pharma packaging materials Primary Packaging Material (PPM) - is the material that first envelops the product and holds it i.e., those package components and subcomponents that actually meet the product, or those that may have a direct effect on the product shelf life e.g., ampoules and vials, prefilled syringes, IV containers, BLISTER foils and base films etc. Secondary Packaging Material (SPM )- as the name suggests, is outside the ambit of the primary packaging and used to group primary packages together e.g., cartons, boxes, shipping containers, injection trays, shrink wraps etc. Tertiary Packaging Material - is used for bulk handling and shipping e.g., barrel, container, shippers, etc. Thus, with various market trends in technology, customer needs, regulatory compliances the role of packaging development has also evolved and can be defined as a cell based on various job responsibilities.

organisations it is merged under R&D. However, recently giant organisations which are hard core research based have R&D PKGG as a different cell all together, dedicated to selection, evaluation, testing of primary PM freeze vendors for primary packaging material. Packaging is an important component in the development of various drug formulations in pharma industry and has a close relationship with pharma preparation which is a major concern to the drug stability and safety. The selection of packaging material is made based on its

efficacy and performance characteristics in preserving the quality, potency and safety of the pharma products. The stability testing of pharma products and compatibility testing of packaging materials is an integral part of R&D in pharma industry. The stability of a drug in solid and liquid dosage forms depends on the efficacy of the packaging materials to protect the drug from chemical degradation and changes in physical characteristics such as appearance, hardness, friability, dissolution, disintegration, weight variation, moisture contents

and mechanical durability, i.e. all those factors that have a say in its shelf life. This is particularly necessary for the storage of the products under accelerated conditions. It has been observed that the use of substandard packaging materials by some pharmaceutical industries leads to stability problems, packaging materials - drug interaction, poor efficacy to moisture barrier and formation of hazardous materials. In order to study the effect of environmental factors on the packaging efficacy of solid and liquid dosage form preparations, there’s a study of stability of a number of selected pharma products in packaging materials using glass, aluminium foil, plastic, paper and other materials as primary or secondary packaging material to determine the extent to which these materials are effective in providing protection to the product and in maintaining its desirable physical and chemical characteristics under the proposed storage conditions. It is intended to evaluate the shelf lives of the products stored in different packaging materials and examine their efficacy and performance characteristics in maintaining the product integrity for a prolonged period of storage. This job responsibilities of many Indian manufacturers is still a part of R&D whereas many giant manufacturers have moved on with the setting up of R&D

packaging along with a product development team. b) Artwork Development Team Or Commercial Packaging Development Once the product is developed and ready for commercialisation, the R&D team hands over the product for commercialisation. From here, the process of artwork development, approval processes through various departments like R&D, QA, QC, production, marketing for designing and branding, regulatory and medical starts. This team looks into data collection for artwork development which comprises ◗ Text matter for artworks ◗ Dimensions – for primary, secondary, tertiary packs ◗ Dimensions for primary packaging material - is decided by change parts available. Hence the team should have good knowledge about operations involved in filling and packing of the product. ◗ PMS - packaging material specification development. ◗ BOP – bill of material development for first commercial run. ◗ Artwork approval, release, shade card approval etc. ◗ Database creation and management – it refers to storage in hard and soft copies of documents like - artworks copies, PMS, drawings of change parts and packaging materials. For e.g. drawing of glass ampoule or vial, blister mock ups etc. ◗ Technical developments like

THIS TEAM ALSO PLAYS A VERY VITAL ROLE IN COORDINATION FOR ALL NEW DEVLOPMENTS

Job responsibilities of packaging development cell a) R&D Packaging This team is a part of R&D functions where product and packaging development take place simultaneously. In many

Chart 1

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PACKAGING SPECIAL change parts, complaint evaluation, transit trials etc. This team also plays a very vital role in coordination for all new developments. In most of the organisations in India, this cell caters to all the developmental activities including the one mentioned under A) R&D - packaging C ) INPROCESS QC FUNCTIONS - IPQC cell This cell is an integral part of manufacturing plant under QA and QC which mainly looks into: ◗ Release of printed PM for production ◗ Testing of PM ◗ Evaluate complaints and CAPA ◗ Setting up standard testing procedures ◗ Carry out engineering/ production trials for new

34 EXPRESS PHARMA July 16-31, 2018

THIS IS A CHALLENGING JOB FOR THE LEADERS WHICH THEY HAVE BEEN CARRYING OUT EXTREMELY ASSERTIVELY AND EFFICIENTLY .OVERALL , THE ROLE OF PACKAGING DEVELOPMENT TEAM CAN BE SEEN AS GIVEN BELOW

Chart 2

developments in co-ordination with team A and TEAM B. This comprises change part development and evaluation , product filling, sealing (capping ) and packing trials. ◗ Simulate shipper packing or conduct dummy trials Thus the role of packaging development as a cell has undergone several changes within the organisation as well. Refer flow chart below: However, it is of paramount importance that packaging leaders address the various packaging functions under one roof without fragmentation. This is a challenging job for the leaders which they have been carrying out extremely assertively and efficiently. Overall, the role of packaging development team can be seen as given below (See Chart 2).

PACKAGING SPECIAL

Adhesive tracking systems in packaging industry Suprotik Das, MD, Nordson India, in this article, focus on one aspect of packaging — the application of hot melt adhesives (HMAs) for different bonding applications WITH THE Indian consumer products industry becoming more and more competitive, today’s businesses are faced with two critical imperatives: ◗ Constantly improve product features, in order to remain attractive to consumers. ◗ Manufacture these products at the lowest possible cost. Why? Because only if your products are more attractive from those of your competitors, will there be a reason for your customers to prefer your products over those of competition. With that, will come greater market share and greater success. And minimising the cost of manufacturing something is always an advantage. So, why is this important for packaging professionals? Two reasons: ◗ Badly packaged products result in costly rejects. And while rejects detected in the factory are bad enough, those detected at the point of sale are a disaster! Exhibit 1 is a photograph taken recently in a supermarket in Bengaluru. It shows numerous cartons where the adhesive has popped open. Needless to say, such defective products never get sold. ◗ Perhaps more critically, packaging has evolved into something greater than a means of protecting a product. Today, packaging is a critical part of the marketing communication process. Marketers often spend enormous amounts of money on slick advertising to create a brand. But, just as an expensive TV commercial says something to your customers, a badly sealed, open carton on a supermarket shelf silently but eloquently says something about your company, your product and your credibility. Interestingly, many businesses completely ignore the damage that is done to the brand by a poorly packaged product, even though such a product has the potential to do grave and long-lasting damage to their brands.

Exhibit 1

A typical application might, for instance, be the tamper-evident sealing of carton flaps using HMAs. For creating consistently sealed cartons, it is not just important to apply the HMA at the right quantity and the right place. It is critically important to know whether that has happened. This knowledge allows for incorrect applications to be immediately corrected, so as to limit the damage. It is for this reason that the ability to track the application of HMAs in real time, has become so important. Nordson Corporation, a leading manufacturer of adhesive dispensing systems, has recently launched a product that provides this capability. The Nordson ProBlue Liberty ATS (Exhibit 2) provides a way to track and measure adhesive usage in real time. (ATS stands for Adhesive Tracking System.) The system combines all the benefits of an automatic fill, tankless melter, with the cost-saving capability to minimise adhesive consumption while improving package quality. Here’s how it works: Solid pellets of HMA are fed on demand into the heated grid of this tankless melter, from a bulk storage container. The HMA gets rapidly melted in the grid and is ready for application in a very short time.

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Exhibit 2

Exhibit 3

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PACKAGING SPECIAL This molten HMA flows through the manifold into an integrated flow meter (Exhibit 3) for direct flow measurement. The HMA flows around the gears of the meter, causing them to rotate. Inductive pickups sense this rotation and send pulses back to the controller. The HMA now continues its path through the hose to the applicator. As the applicator dispenses the adhesive, the integrated flow meter allows for real time tracking of the volume dispensed, and alerts the system when the amount of HMA is out of a predetermined range. The user has the ability to set upper and lower limits of the average quantity of adhesive per product. If the adhesive volume goes outside the set limits, the system can be configured to send a signal based on custom specifications. For instance, an increased system pressure could result in too much adhesive being dispensed. In such a situation, the system would register that the volume is outside the set limits. The line would stop and the light tower would be illuminated. Like-

Exhibit 4

Too much adhesive could result in a defective product, with excess adhesive getting smeared on decorative parts of the package wise, a clogged nozzle or failed solenoid would cause the system to notice a drop in adhesive volume. It would stop the line, preventing wasted product and potential pop-opens. By tracking the precise amount of adhesive dispensed onto a package, users can ensure that the required amount of adhesive has been applied –

not too much, not too little. Too much adhesives causes adhesive waste and increases cost. In fact, too much adhesive could actually result in a defective product, with the excess adhesive getting smeared on decorative parts of the package. Too little adhesive can cause an inadequate seal and a product that will

get rejected. The ATS also provides a product detector located on the production line that senses products from leading edge to leading edge. This information is sent back to the control box. Adhesive is measured over the product detector’s pitch. The controller then uses this information to calculate the average

weight per product (Exhibit 4). These adhesive tracking capabilities can also be added to existing ProBlue or ProBlue Liberty melters using an upgrade kit. The flow meter can be directly attached to a manifold hose port, or it could be remotely mounted with a heated hose. To summarise, the ATS feature does three things. It enables the customer to: ◗ Optimise and track add-on (adhesive) per product, thus eliminating waste, while ensuring that the required amount of adhesive has been applied. ◗ Prevent out-of-control processes with operating alarms and line stops. ◗ Analyse historical data to improve processes. The use of this technology enables the user to enjoy the benefits of real time flow tracking. It ensures that the adhesive process delivers products of consistent quality at the lowest product cost. In short, the possibility of excessive adhesive consumption is virtually eliminated, as is the possibility of poorly sealed packages leaving the factory.

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PACKAGING SPECIAL NEWS

Japan’s Toyo Aluminium inks JVwith SVAM Packaging To offer innovative solutions in healthcare packaging and anti-counterfeit solutions IN ORDER to defeat the menace of counterfeit medicines and develop greater standards of Healthcare & Food Packaging, SVAM Packaging Industries has partnered with Japanese Packaging Giant Toyo Aluminium. This is amongst the biggest FDI in Indian healthcare packaging industry. This partnership is in alignment with Government of India’s ‘Make in India’ initiative and would help create employment in the country. As per the agreement, Toyo Aluminium will acquire 33.4 per cent equity in SVAM Packaging Industries and bring in its advanced Japanese technology in the packaging sector and also focus on anticounterfeiting solutions to control the problem of spurious drugs and medicines. Through this partnership, the two companies will leverage each other’s strength in R&D and efficient human resource. Svam Toyal will manufacture innovative aluminium foil packaging solutions such as laminates for pharmaceutical and food packaging industry. The company will set up manufacturing units both within and outside India and offer innovative products in healthcare, food and beverage packaging segment. The main manufacturing unit and central hub would be within India itself. The company intends to increase production on a massive scale of the Cold Form (Alu Alu) foil as well as other products such as special aluminium lidding foils, child resistant laminates, toyal lotus, specialised printing applications and other cost effective solutions for the packaging industry. Satish Ailawadi, MD, SVAM Packaging Industries said, “We are privileged to partner with Toyo Aluminium who are world leaders in creative and innovative

(L-R) Hiroshi Yamamoto, President, Toyo Aluminium KK with Satish Ailawadi, MD Svam Packaging Industries

packaging products. This partnership will help us serve our customers better and provide safer packaging products

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in healthcare as well as food and beverage industry.” “Our team continuously monitors new trends in the

packaging industry to develop special features that can add value to the products, brands and anti-counterfeiting solu-

tions and also cultivates new cost effective laminates to ensure finest packaging for the pharmaceutical industry,” added Ailawadi. Speaking on the occasion, Hiroshi Yamamoto, President, Toyo Aluminium said, “India is a growing market with requirement of innovative products. We want to invest in India’s remarkable growth story and ensure product safety through offering our innovative technology in the packaging domain.” “We are proud of the fact that we are able to offer the high-level technological solutions that we have developed over many years to produce pioneering products which are unique in the industry. We will continue our advanced research and development to unravel the infinite possibilities of aluminium so that we can make products safer for the end consumer,” Yamamoto said. EP News Bureau

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PHARMA ALLY PRODUCTS

Burkert launches ‘8098 - FLOWave SAW flow meter’

urkert has launched a new product '8098 FLOWave SAW flow meter' to the global and Indian markets recently. The product is totally a new invention and a breakthrough in fluid measurement equipment. The product is first of its kind and a patent of Burkert. The 8098 flowmeter is part of the FLOWave product range. It uses the SAW (Surface Acoustic Waves) technology and is mainly designed for applications with the highest hygienic demands (mainly for pharma companies). This is achieved by using: - Suitable stainless steel materials — a measuring pipe free of any wet-

ted parts except for the actual pipe — the ideal outer hygienic design. FLOWave offers a range of integrated functions, including flexibility advantages, ease of cleaning, compact dimensions, light weight, easy installation and handling, and is compliant with numerous standards. Optimal measurement results can be achieved with homogeneous, air and solid free liquids. Integrated viscosity compensation can be used for higher viscous liquids. Gas and steam cannot be measured; however, their flow does not have any negative effect on the device or its operation. Other liquids flowing through again

No parts in the measuring pipe

afterwards are measured correctly as before. Special functions derived from further process values (density

factor, acoustic transmission factor) offer additional information about the particular liquid in use mentioned below.

◗ Conforms to hygienic requirements, CIP/SIP capable ◗ Ideal for liquids with low or no conductivity ◗ Digital communication ◗ Compact, light weight and energy-efficient Contact details Bürkert Fluid Control Systems Markerting Manager Bürkert-Contromatic M6-Vikram Sarabhai Instronic Estate, Type II, Thiruvanmyur Chennai - 600041, India Mob No : +91 98405 38813 Mail ID : ramasasthri.j@ burkert.com sales.in@burkert.com www.burkert.in

Gandhi Automations’clean room high speed doors a necessity BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which one can limit the amount of dust and dirt in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process. Clean rooms have become integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the doors which needs to be chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside

38 EXPRESS PHARMA July 16-31, 2018

◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316

temperature, humidity etc. Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for

above purpose. The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility.

High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure

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

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

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

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

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

SLITTER COATING LINE

Ÿ Producing 60 Micron PVC Film by Direct

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

Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area

LAMINATOR

Ÿ 6000 Sq. Mtr. Built-up Area

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

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Tablet Press Vantix P Series

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Sejong machines are high productivity equipment and value for money, has always been. For almost over 20 years, Sejong has enjoyed your trust and patronage. To all who stand by us, we thank you for your faith and support We will do our best each time.

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Allpharm Technologies Pvt. Ltd. mail@allpharm.in Phone: 9769199633

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OSMOMETER 3250

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Corporate office: 107, ACME Industrial Park, I.B. Patel Road, Goregaon (E), Mumbai - 400 063 Tel: 022-26865341/42/43 Mobile: 9833767752 Email: info@gaylordpharmasystems.com Website: www.gaylordpharmasystems.com

315, Tantia Jogani Industrial Esate, J. R. Boricha Marg, Opp. Kasturba Hospital, Mahalaxmi, Mumbai - 400 011. Phone: 022-23000008, 022 23000149

E-mail: at lantoent@ gmail.com

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LABORATORY EQUIPMENTS

Lab Stirrers Hot Plate Magnetic Stirrers

Walk-in chamber

Refrigerated Centrifuge Deep freezer

Single Door Refrigerator

Laboratory Centrifuge

Cyclomixer

Mini Rotary Shakers

Incubator Shaker

REMI SALES & ENGINEERING LTD. Remi House, 3rd Floor, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai - 400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com l Website: ww.remilabword.com

July 16-31, 2018

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July 16-31, 2018

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July 16-31, 2018

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July 16-31, 2018

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BUSINESS AVENUES

July 16-31, 2018

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BUSINESS AVENUES

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July 16-31, 2018

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July 16-31, 2018

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July 16-31, 2018

PHARMA LIFE RECOGNITION

Kiran Mazumdar-Shaw elected full-term member of the Board of Trustees of MIT,USA Mazumdar-Shaw will serve a five-year term

iran Mazumdar-Shaw, Chairperson and Managing Director, Biocon, has been elected as full-term member of the MIT Corporation, the board of trustees of the Massachusetts Institute of Technology (MIT), Cambridge,

Massachusetts, USA. She is among the eight full-term members who will each serve a term of five years starting July 1, 2018. Commenting on her election, Mazumdar-Shaw said, “I am truly honoured to be

elected as a full-time member of the board of trustees of MIT and look forward to contributing to this venerable institution’s continuous journey of making a meaningful difference in solving various challenges of the world. It is inspiring to be a part of this

premiere research university, which is engaged in advancing knowledge, leveraging science and technology to address fundamental human needs for food, shelter, energy, transportation and social harmony.” EP News Bureau

APPOINTMENT

Lupin appoints Yashwant Mahadik as President – Global HR He will lead the HR function for Lupin globally LUPIN ANNOUNCED the appointment of Yashwant Mahadik as President – Global Human Resources (HR). He will lead the HR function for Lupin globally. Mahadik has nearly three decades of experience across diverse sectors such as consumer and healthcare in global organisations. His last assignment was with Sun Pharmaceuticals as Global Chief Human Resources

56 EXPRESS PHARMA July 16-31, 2018

Officer prior to which he held HR roles with increasing responsibilities at companies like Philips, Johnson & Johnson, AstraZeneca and Colgate Palmolive. Mahadik has an MBA in General Management and International Human Resource Management from University of Sheffield, United Kingdom, and is a Certified Associate Executive Coach from Franklin Covey

and Results Coaching System, USA. He is a renowned thought leader in HR and has collaborated with leading global academicians to conceptualise and execute strategic initiatives in the field of Human Resource Management. Commenting on the appointment, Nilesh Gupta, MD, Lupin said, “Our strong HR practices and employee experience have

led Lupin to be consistently recognised as one of the best companies to work for. We are confident that Mahadik will continue to build on our strong HR foundation and help us create a world-class organisation.” Mahadik will be based in Mumbai, India and will report to Vinita Gupta – CEO, Lupin and Nilesh Gupta, MD, Lupin. EP News Bureau

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