Express Pharma (Vol.13, No.21) September 01-15, 2018 by Indian Express

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CONTENTS MARKET

Vol.13 No.21 September 1-15, 2018

Chairman of the Board Viveck Goenka

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

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

70TH IPC DATES ANNOUNCED AT IDMA AGM

On Teachers’ Day, experts comment on ways to improve pharmacy education in the country | P16

PHARMALYTICA 2018 CLOSES ON A HIGH NOTE

MANAGEMENT

DOP ORGANISES INDIAN PHARMA EXPO 2018

Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Tanuvi Joe New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht

RESEARCH

PHARMA ALLY

LUPIN’S NAGPUR PLANT GEARS FOR FUTURE GROWTH

Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer)

Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis

P26: INTERVIEW Dr Piyush Gupta Associate Director, GNH India

BEHIND ALL THE HYPE AND HOOPLA ABOUT BIOSIMILARS

PFIZER, ASTELLAS REVISE TWO CANCER DRUG TRIAL PROTOCOLS TO SPEED UP RESULTS

MODERATE ‘BAD CHOLESTEROL’ LEVELS TIED TO EARLY DEATH FOR HEALTHY PEOPLE

EARLIER ONSET OF TYPE 1 DIABETES LINKED TO GREATER HEART RISK, SHORTER LIFE

4TH EDITION OF SMART INDUSTRY CONFERENCE HELD

MARINOMED BIOTECH OBTAINS EU-WIDE CERTIFICATION FOR NEW COLD MEDICATION

PHARMA LIFE

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

AJAY BHATT JOINS INTAS PHARMACEUTICALS AS THE GLOBAL PRESIDENT FOR HR

Manager Bhadresh Valia

Express Pharma® 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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EDITOR’S NOTE

Revitalising pharmacy education

ith September 5, Teachers’ Day around the corner, Express Pharma asked faculty from various institutes to suggest ways to rejuvenate India’s pharmacy education system. We also chose to focus on how pharmacognosy, an ancient science, can be re-engineered to serve present and future needs of patients and the pharmaceutical sector. Pharmacognosy, as the study and use of plants as medicinal agents has given us cures to a range of diseases from Alzheimer’s disease to malaria. Properly harnessed, this branch of pharmacy education has vital clues for new drug discovery. The good news is that the Pharmacy Council of India (PCI) is coming out with a new curriculum in pharmacognosy at the Masters level from 2019-20, according to Dr B Suresh, President, Pharmacy Council of India (PCI). While this news on an updated pharmacognosy curriculum is welcome indeed, the PCI, as India’s premier pharmacy education regulatory body, has to introspect on other promising courses which were started with good intentions but are today in danger of losing their way. For instance, of late, students of the Doctor of Pharmacy (Pharm D) course, especially those run by government pharmacy colleges in a few states, have been holding a few protests to draw attention to the dearth of permanent staff to teach the course as well as the lack of job opportunities post the course. The main criticism is that the government failed to create a specific role for these students in government medical colleges after introducing the course. The six year Doctor of Pharmacy ( Pharm D) course, which was approved in 2008, was positioned as a pharmacy doctoral programme, with the attraction that students who completed the six year programme would be eligible to register for a PhD and add the much coveted prefix Dr before their name. Students could join after their (10+2) exams for five years of academic study followed by a year of clinical internship or residency. B.Pharm graduates could be admitted as lateral entry candidates to the fourth year of Pharm D programme for the remaining three years (two years of study and one year of internship or residency). While including all aspects of the existing pharmacy courses, the Pharm D course was designed to have strong emphasis on clinical pharmacology and patient counselling, including

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While there are good intentions, it is the implementation which threatens the viability of initiatives like the Pharm D course

giving patients more information about their disease, the drugs they are prescribed and the lifestyle modifications they needed to make. These aspects are critical to improve patient outcomes, especially in so-called lifestyle related conditions, like hypertension and diabetes, where changes in diet and exercises require to be long term. Counselling can increase chances of patients undertaking long-term changes but doctors, especially in public hospitals, rarely had the time to spend with patients so this aspect was neglected. But did clinical staff like doctors and nurses, perceive a threat from these activities? Did they view Pharm D graduates as a dilution of their authority and roles, and becoming a barrier between them and their patients? These issues can be addressed with more dialogue between doctors, nurses, as well as with patients. But as the ‘new kids on the block’, the onus is on Pharm D students to go the extra mile to gain this acceptance. Here too there is good news. Senior faculty like Manjiri Gharat, Vice President & Chairperson, Indian Pharmaceutical Association - Community Pharmacy Division and Vice-Principal, KM Kundnani Pharmacy Polytechnic, Ulhasnagar recognise that the the Pharm D course is a good course. She says that she has noticed that students of this course have a better knowledge of clinical pharmacy and are therefore in a position to make a real difference in treatment outcomes. But she too agrees that like any new course, it will take time to evolve and time for industry to recognise the capabilities of the students for employment. While the authorities like PCI have made some efforts in this direction, she feels that they definitely need to strengthen these efforts. Her suggestion is that posts of clinical pharmacists in the government sector need to be created so that Pharm Ds can be employed in both the private as well as public sectors. Thus, while there are good intentions, it is the implementation which threatens the viability of initiatives like the Pharm D course. In the case of pharmacy education, this could drive away an entire generation of talent. Thankfully, the suggestions of the experts in this issue give us hope that there are enough senior faculty willing and able to enthuse new life into pharmacy education in India.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENTS

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

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

Express Public Health Awards will honour Champions, Visionaries and Game Changers in Public Healthcare priority, Healthcare Sabha's 4th edition will focus on three core areas: Health economics, equity and efficiency. Public health stalwarts will highlight the role of ethical practices in protecting patients of all socio-economic backgrounds.

Key topics to be discussed are ◗ Health Economics, Equity and Efficiency: Where does India stand? ◗ Strategies for capacity building in public health ◗ PPPs in healthcare: How can

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

Delegates profile will include the following ◗ Secretary, Addl. Secretary, Jt. Secretary, DG, DDG etc from Ministry of Health & Family

Welfare, Government of India & various State Government ◗ NHM Mission Directors of various States ◗ NHM Policy Makers and Planning Officials ◗ Dignitaries from Central Drugs Standard Control Organisation (DCGI, Jt. Drugs Controller, Deputy Drugs Controller) ◗ Key dignitaries from NHSRC/SHSRC, NIHFW ◗ Dignitaries from State Health Corporations, State Health Society and State Health Mission Director ◗ Director, Deputy Director of

autonomous institutions like AIIMS, JIPMER, PGIMER, NIMHANS etc. ◗ Dignitaries from ESIC (Director General, Medical Commisioners, Deputy Medical Commisioners) ◗ DG - AFMS, Addl. DG-AFMS ◗ DG, ED, Director, Deputy Director - Railway Health Services, CMOs of various railway zones ◗ Chief Procurement Officer, medical superintendents, administrative heads of premier government and municipal hospitals from various states and cities To be held concurrently with Healthcare Sabha, the Express Public Health Awards will honour Champions, Visionaries and Game Changers in Public Healthcare. EP News Bureau

CPhI & P-MEC India to be held in Delhi NCR from Dec 12-14, 2018 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 weeklong 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.

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

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

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

analytica Anacon India,India Lab Expo to be held in Hyderabad The event from September 6-8, 2018 will give profound insights into science and research analytica Anacon India and India Lab Expo are Indiaâ&#x20AC;&#x2122;s largest and most important platform for the analysis, laboratory-technology and biotechnology market. They have the potential for more than 259 exhibitors and more than 7,714 visitors in three halls. The event will be held in Hyderabad from September 6-8, 2018. The event will focus on innovative and applied product and sys-

The conference will give insights into science and research. International experts will present latest techniques tem solutions for laboratories in the industrial, research and science sectors. As the industryâ&#x20AC;&#x2122;s definitive forum, fair and conference gather all relevant information about the latest developments. Both events will cover the entire value chain for industrial and research laboratories. The focussed exhibition sectors will give visitors a comprehensive overview of the market, innovations and best-practice examples: analysis, biotechnology, laboratory technology, quality control, measuring and testing. The conference is tailored to the Indian market, so it will give profound insights into science and research. It is where international experts present the latest techniques in all application sectors. International market leaders as well as local Indian manufacturers will participate in the trade shows. EP News Bureau

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MARKET POST EVENTS

70 IPC dates announced at IDMAAGM th

70th IPC is scheduled on December 21-23, 2018 will be held at Amity University Campus, Noida AT THE 26TH Annual General Meeting of Indian Drugs Manufacturers Association (IDMA), Tamil Nadu, Puducherry & Kerala State Board (TNPKSB) recently held in Chennai, the dates for 70th IPC were announced. 70th IPC scheduled on December 21-23, 2018 will be held at Amity University Campus, Noida. This was announced by Atul Nasa, Organising Secretary, Local Organizing Committee (LOC) of 70th Indian Pharmaceutical Congress (IPC) who along with Dr Vijay Bhalla, Treasurer, Local Organizing Committee (LOC) of 70th Indian Pharmaceutical Congress (IPC) were in Chennai to take part in the event. J Jayaseelan, Chairman – IDMA TNPKSB, in his inaugural address welcomed all the executives and members present in the meeting. SV Veerramani, Immediate Past National President and CMD –Fourrts (India) Laboratories introduced and recognised all the national executive committee members present in the meeting with shawls and mementos. Deepnath Roychoudhury, National President, IDMA, in his well defined deliberation discussed on various developments affecting the Indian pharma industry, be it regulatory compliances, pricing policies, fixed dose combinations, genericisation, APIs, export, institutional business etc. Daara B Patel, Secretary General, IDMA, Mumbai thanked all the members for sparing their valuable time to participate in the meeting. Nasa informed the house that Padmashree Dilip Shanghavi is the President of 70th IPC and they are therefore expecting a huge quality partici-

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Nasa requested all participants to register themselves for 70th IPC as early as possible and support such a mega event pation from industry and academia. He informed the house that Dr Ashok K Chauhan, Founder President, AMITY Group of Institution and RC Juneja, Chairman, Mankind Pharma are the chief patrons. He said, “We all are working under the guidance of BR Sikri, who is Chairman of the 70th IPC. The theme of the conference is Pharma Vision: In-

dian Pharma Industry – A Global Leader. We are expecting maximum participation from pharma industry. The scientific programme for the conference are designed on the theme of the conference.” Nasa requested all the participants to register themselves for the congress as early as possible and support such a mega event.

Dr Sanjoy Mitra, MD, SMSRC, Kolkata, in his exemplary interaction on 'Prescription trends in the face of recent developments in the Pharma Industry' shared his data analytics on current issues like NLEM, Generics, GST, FDC and new drug launches. In his summary, he concluded that building brands with individualistic

strengths will be the right step form sustaining in the market place without any adversity due to Governmental policies. The meeting concluded with the celebration of birthday of Veerramani, Immediate Past National President and CMD –Fourrts (India) Laboratories. EP News Bureau

MARKET

PharmaLytica 2018 closes on a high note The Hyderabad event witnesses increase in visitor footfall THE FIFTH edition of PharmaLytica, hosted by UBM India, successfully concluded at the Hitex Exhibition Centre recently. This year, PharmaLytica witnessed a turnout from exhibitors of the pharma industry with a whooping increase of 24 per cent in visitor footfalls. Positioned as India’s most comprehensive analytical, biotechnology, lab equipment, pharma machinery and pharma packaging event, PharmaLytica 2018, brought the pharmaceutical fraternity under one roof to witness the latest industry trends, innovations and conduct business. A series of insightful sessions and panel discussions convened by industry experts were organised to discuss the trending subjects in quality assurance, technology, quality culture and regulatory & compliance standards in the pharmaceutical sector. The conference focussed on the growth phase, challenges and how the industry can again truly distinguish itself in the global pharma industry in the years to come. The expo is set to get bigger by further expanding its reach into the Western region with its strong pharma market by hosting PharmaLytica for the first time in Mumbai from June 10 – 12, 2019. While targeting the South-West market with sectors such as lab and analytical, pharma machinery and packaging, PharmaLytica will also launch API and Excipients zone to continue its pre-eminence in this region. Yogesh Mudras, Managing Director, UBM India said, “We are thrilled that PharmaLytica 2018 witnessed such a great participation from Indian and global firms. At UBM India, we are committed to encouraging novelty in products and an exchange of ideas within the framework of our exhibitions.” Speaking at the event, Uday Bhaskar, Director General, Pharmexcil said, “I’m happy to be associated with PharmaLytica which has been helping the industry and visitors to understand the latest equipment and

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trends. It is the one place where they witness an entire range of the industry and get to know about new developments. After all, machinery plays an important role as per FDA guidelines,

and this expo has been facilitating machinery manufacturers and product manufacturers. I’m happy that UBM India did a meticulous job in this domain.” EP News Bureau

MARKET

DOP organises Indian Pharma Expo 2018 The expo has provided eminent stakeholders in the pharmaceutical Industry as a chance to generate new business leads and to maximise revenue potential DEPARTMENT OF Pharmaceuticals (DoP) falling under the Ministry of Chemicals & Fertilisers, Government of India organised the Indian Pharma Expo 2018. The expo was inaugurated by Sachin Kumar Singh CEO, Bureau of Pharma PSUs of India (BPPI), Dr PL Sahu Principal Scientific Officer, Head â&#x20AC;&#x201C; R&D at Indian Pharmacopoeia Commission along with Dr Monica Bhatia MD CIMS Medica India & Middle East at Pragati Maidan New Delhi. With the Indian pharmaceutical industry growing leaps and bounds, this event has helped the industry overcome several challenges, by identifying cost-effective production techniques, procurement, logistics, etc. This year too, the IPE was an ideal platform for the companies to witness latest advancements in manufacturing, research and development, packaging solutions, supply chain management, franchising, distribution and many more domains. In addition, the expo has provided eminent stakeholders in the pharmaceutical Industry as a chance to generate new business leads and to maximise revenue potential. The Business Excellence Awardsâ&#x20AC;&#x2122; in the presence of Chief Guest Mansukh Mandaviya, Ministry of Road Transport and Highways, Ministry of Shipping, Ministry of Chemicals and Fertilizers; Government of India has felicitated achievers in the pharmaceutical industry in the fields of research and development, active pharmaceutical ingredients, formulations, manufacturing, packaging, distribution, marketing, franchising, outsourcing, supply chain and logistic management, and other support services. The awards has also provided much needed recognition to proactive and innovative approaches to help

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improve the standards of pharmaceutical delivery. Hence the IPE, has added to the prestige and honour of the Business Excellence Awardees. Being a global event and total of 8000+ visitors attending also from countries like China, Southeast Asia, Middle East and Africa the IPE and Business Excellence Awards, brought together eminent personalities from different sectors of Pharmaceutical, Non-pharmaceutical, and Allied-healthcare industries and provided them with an opportunity to exchange information, products, services, and ideas to help identify new business opportunities. The Industry have gained the most, from this one of a kind event by understanding the latest trends and innovations the market has to offer. EP News Bureau

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

nologies/ Services. Contact details: Paresh Jhurmarwala CEO KENYA PHARMA EXPO 2018 E-mail: contact@ kenyapharmaexpo.com

Website: www.Kenya PharmaExpo.com

GLOBAL PACK 2018 Date: November 23-25, 2018 Venue: Labh Ganga Exhibition Centre, Indore, MP

High-speed diverters

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

Track design flexibility

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

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4TH EDITION OF HEALTHCARE SABHA Date: October 5 and 6, 2018 Venue: Delhi Summary: Healthcare Sabha's 4th edition, organised by Express Healthcare, a publication of the Indian Express Group, will bring together a think tank of policy experts, public health officials, and other key stakeholders to discuss and deliberate on these issues and come up with innovative strategies/solutions as the nation gears up for the most transformational moment in its public health journey. Healthcare Sabhaâ&#x20AC;&#x2122;s 4th edition will focus on three core areas: Health economics, equity and efficiency. Public health stalwarts will highlight the role of ethical practices in protecting patients of all socio-economic backgrounds. Contact details Vinita Hassija vinitahassija@gmail.com

KENYA PHARMA EXPO 2018

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Date: October 17 -19, 2018 Venue: KICC, Nairobi, Kenya Summary: The international pharma exhibition on technologies and trade will focus on East & South African Pharmaceutical Industries. The expo will be organised by GPE Expo where pharma machinery and alliedindustries OEMs across the world will exhibit their Tech-

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cover )

On Teachers’ Day, experts comment on ways to improve pharmacy education in the country

INSIDE

18 16

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BEGINNING OF A NEW ERA

THROUGH THE TEACHERS’LENS

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THE MAIN FOCUS

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cover )

Beginning of a new era Pharmacognosy in India is at a nascent stage. Industry experts comment on the need to reengineer the subject in India and ways to attract younger talent to pursue it more aggressively By Usha Sharma

Build excitement in the learning process F

rom time immemorial medicinal plants have been the source of many new drugs and the discovery of new molecules. With the systematic organisation of these plants and their uses, besides trying to find the active ingredients that are responsible for their medical action, the subject of pharmacognosy evolved and had stood the test of time and continues to be one of the most important resources for new drug discovery. However, with the changing scenario to develop new drugs at a faster rate along with lower costs, the synthetic pathway to develop drugs evolved. The technology for delivering drugs in the human body also underwent a paradigm shift and the era of biosimilars and biologicals almost swept the pharma industry from its feet. In this

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changing and challenging environment, the subject of pharmacognosy did not respond in time to look at newer approaches of understanding the drug discovery process and the newer scientific emphasis that was required in validation of scientific and therapeutic claims of such medicinal plants. Further, the sources of such medicinal plants continue to come from natural reserves rather than organised farming process. Unlike the Chinese system of traditional medicines, pharmacognosy in India did not integrate enough with the Indian system of medicine in providing the level of support that was expected of it. All these factors resulted in pharmacognosy not being one of the preferred subjects of study at advanced levels and led to the decreased number of human re-

DR B SURESH Vice Chancellor, JSS Academy of Higher Education & Research, Mysuru & President, Pharmacy Council of India

source in this segment of the pharmacy profession. Having said all this, it need not be overemphasised that na-

ture would continue to be our resource for many drug discoveries and developments in the future. The need for the same is as rightly put — reengineering Pharmacognosy as a subject and make it exciting for students to take it up as a career choice. Some of the suggestions that are made and also being actively pursued by the Pharmacy Council of India includes: ◗ Integrating modern analytical techniques in the scientific validation of the medicinal plants and separation techniques. ◗ Development of standards for active ingredients of medicinal plants ◗ Herbal Pharmacovigilance ◗ Herbal Pharmacology ◗ Pharmaceutical technology for herbal products ◗ Newer approaches to drug discovery from natural products

◗ Understanding Indian systems of medicine and development of standards without affecting the fundamental basis on which the system is practiced ◗ Biotechnological basis for drug development ◗ Digital identification of medicinal plants and their active ingredients ◗ Geo-Pharmacognosy The vision is to create excitement in the learning process while linking towards the goal of new drug discovery and career opportunities. The Pharmacy Council of India is in the process of organising a series of workshops and seminars in this regard and would come up with a new curriculum in pharmacognosy at the masters level to be offered from the year 2019.

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THE MAIN FOCUS

Need to re-engineer pharmacognosy science T

he pharmacognosy branch of pharmaceutical sciences can remain in the pharmacy profession with re-engineering the contents according to the views of a pharmacist and not on the basis of botanist perceptions. This branch can be reengineered on the basis of the following points: ◗ The monographs of a crude drug is to be taught to the students keeping the pharmacology point of view in mind. For instance, quantity of active constituents in a given amount of material. ◗ Everybody in the world feeling the necessity of natural treatment of minor ailments, with respect to the indigenous system of medication, that is based on natural resources specially plants/crude material is to be identified by the students just by a few basic points. ◗ Fingerprinting methodology to be included to identify the

crude drug by a pharmacist instead of botanical points of identification and standardisation. ◗ Nowadays farming is promoted with use of pesticides and organic manure that causes the problem in identification of drugs. That too should be taught to the students. ◗ More than 90 per cent of public in the country believe in natural formulations. That’s why common household preparations with proper method of preparation is to be taught to promote our culture and traditions by means of long life. ◗ Particular phyto-constituent and their dose in extract form is to be taught to students for preparation of formulations. ◗ The production part of herbs extract is to be taught to students to make them skilled in proper handling of extract without loss of its potency.

DR SWARNLATA SARAF Professor Dean, Faculty of Technology, University Insitute of Pharmacy-Pt Ravishankar Shukla University

◗ Innovative areas like herbal technology and phyto-screening using modern instrument parameters to be included in curriculum. ◗ The newer branch ‘herbal formulation development’ has been evolved that is an amalgamation of pharmacognosy and pharmaceutics to be taught to students. ◗ Pharmacognosy is a branch dealing in ‘Crude Drugs’ that means material giving action in body. Crude drug is any type of naturally occurring, undefined substance obtained from organic or inorganic sources such as plant, animal, bacteria, organs or whole organisms intended for used in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals. The definition of this branch needs to change by addition of herbal technology. ◗ Ayurveda system of medication mainly consists of plants and natural resources and

most importantly classical method of its preparation. It is based on results of continuous efforts of clinical outputs by Ayurvedacharyas. But now things have been changed due to change in farming methodology so claims are different and that cause of change is to be taught to students with respect to Ayurveda preparation. ◗ The content-based crude drug quantity and regional variation causes lots of differences in standards of Ayurveda as well as herbal preparations. In context of pharmacognosy field of specialisation, we should do finger printing of crude drugs with respect to Ayurveda as well as Herbal formulation Industry to know the exact amount that is to be used in preparation. Hence on the basis of the above criteria, things should be kept in mind and reengineering in pharmacognosy should be accordingly implemented.

The subject is essential for pharma science P

harmacognosy subject is an essential area for the development of pharmaceutical sciences. Along with pharmacology, pharmaceutical chemistry and pharmaceutical technology, pharmacognosy is the foundation for the progress and development of pharma sciences. Pharmacognosy is essential for integrative and alternative medicines and for traditional system of healthcare. The knowledge and skill of pharmacognosy is required when one is dealing with all kinds of natural products, phytopharmaceuticals, herbal

products, neutraceuticals and cosmeceuticals. The M Pharm, PG programme has an AICTE and PCI approved specialisation known as M Pharm in pharmacognosy. In the recent years, admission for M Pharm in pharmacognosy is declining. Manipal Academy of Higher Education(MAHE) along with other universities, a centre of integrative medicine and research exists. Pharmacognosy facilities in Manipal College of Pharmaceutical sciences provides a lot of research services for standardisation of Ayurvedic,

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DR N UDUPA Professor and Research Director (Health Sciences) Manipal Academy of Higher Education

Homeopathic and Siddha medicines. A center of Research and Testing of Ayush preparations is being established with the help of Ayush grant in MAHE. Various add on healthcare programmes are conducted by Directorate of Research of MAHE utilising the pharmacognosy department of Manipal College of Pharmaceutical sciences In the private sector, MAHE, is adding additional value in interdisciplinary healthcare research through the pharmacognosy facility. MAHE has the highest number of faculty,

researchers and students pursuing doctoral and post doctoral work with good number of publications. The department has collaborations with leading herbal and Phytopharmaceutical industries. In India there is a Society of Ethnopharmacology with headquarters in Kolkata and one of the leading chapters is in MAHE. An international conference of Ethnopharmacology was organised in MAHE. About 1000 delegates, papers and 100 plenary lectures were delivered during the event focussing on the subject of pharmacognosy.

EXPRESS PHARMA

September 1-15, 2018

cover ) Pharmacognosy as a branch needs to be looked upon as a vast area T

he first commercial pure natural product introduced for therapeutic use as pure compound was morphine from opium poppy plant marketed by Merck in 1826, and is till date the strongest analgesic for extreme surgical and burn related pain. First semi-synthetic pure drug aspirin, based on a natural product salicin isolated from Salix alba, was introduced by Bayer in 1899, and was a master stroke in inflammation and associated pain. Isolation of early drugs such as cocaine, codeine, digitoxin, quinine and pilocarpine, took place, of which some are still in use. Recent drugs include Paclitaxel from Taxusbrevifolia for lung, ovarian and breast cancer, Artemisinin from traditional Chinese plant Artemisia annua to combat multidrug resistant malaria, Silymarin extracted from the seeds of Silybum marianum for the treatment of liver diseases. Thus medicinal herbs and pharmacognosy science provide unlimited opportunities for new drug leads because of the unmatched availability of chemical diversity present within each plant. Due to an increasing demand for chemical diversity in screening programmes seeking therapeutic drugs from natural products, interest particularly in edible plants has grown throughout the world.

Natural product or herbal product industry The natural products or the so called herbal industry, based on medicinal plants, is now a multibillion industry, using either crude medicinal plant parts, standardised powders, extracts, typical formulations of these powders or extracts as tablet or syrups or other dosage form, or as novel delivery systems with greater efficacy in the biological systems because of better absorption.

20 EXPRESS PHARMA September 1-15, 2018

The industry includes the following products: ◗ Therapeutics ◗ Neutraceuticals ◗ Foods ◗ Crude drugs ◗ Standardised extracts/fractions ◗ Traditional formulations: Ayurvedic, Chinese medicines ◗ Phytopharmaceuticals The global herbal medicine market is expected to witness a double-digit CAGR in the forthcoming period. The demand for herbal medicines is gaining positive attraction due to patient demand for herbal therapy. The key players in the herbal medicine market include Tsumura, Schwabe, Madaus, Weleda, Blackmores, Arkopharma, SIDO MUNCUL, Arizona Natural, Dabur, Herbal Africa, Nature’s Answer, Bio-Botanica, Potter’s, Zand, Nature Herbs, Imperial Ginseng, Yunnan Baiyao, Tongrentang, TASLY, Zhongxin, and others. Companies like Dabur, Himalaya, Zandu, Charak Pharma, Baidyanath have launched authentic products based on ayurvedic concepts and providing effective options to practitioners for healthcare management. Various multinational companies have modified their product portfolio strategies including phytopharmaceuticals as an important constituent of the portfolio along with synthetic and biological drugs and

DR MADHU CHITKARA Vice Chancellor, Chitkara University, Punjab

their formulations.

Other emerging areas in pharmacognosy Phytoconstituents as Bioenhancers Many phytoconstituents from medicinal plants have been found to increase the activity of another drug when given in combination with another drug. This may be done by various mechanisms of action of bioenhancers, which may be ■ Promoting the absorption of the drugs into the blood, ■ Inhibiting or reducing the rate of biotransformation or breakdown of drugs in the liver or intestines, ■ Modifying the immune system in such a way that the overall requirement of the drug is reduced substantially, increasing the penetration and efficacy of antimicrobials, into the pathogens even where they become persistors within the macrophages such as

for mycobacterium tuberculosis and such others, modifying the signaling process between host and pathogen ensuring increased accessibility of the drugs to the pathogens, ■ Enhancing the binding of the drug with target sites such as receptors, proteins, promoting the transport of nutrients and the drugs across the blood brain barrier, which could be of immense help in the control of diseases like cerebral infections, epilepsy, and other CNS problems.

New application of old molecules There is growing evidence that the old molecules can be used for new applications through better understanding of molecular biology and clinical observations. For instance, the alkaloid, forskolin from Coleus forskohlii and phytochemicals from Stephaniaglabra, are now being rediscovered as adenylatecyclase and nitric oxide activators, which may help in preventing conditions including obesity and atherosclerosis. Development and commercialisation of Novel Drug Delivery Systems with increased bioavailability and therapeutic efficacy In phytopharmaceutical development, formulation of nano delivery systems including polymeric nanoparticles, nanocap-

sules, liposomes, phytosomes, ethosomes, solid lipid nanoparticles and nanoemulsions offer advantages of increased solubility, availability, stability, decreased degradation, decreased toxicity, better macrophage distribution and others. Regulatory filing of phytopharmaceuticals in different international markets Depending on the country, a herbal product has to be approved for market authorisation after submitting regulatory compliance to agencies like US FDA, MHRA UK, MOH Dubai, TGA Australia, WHO etc with proof of identification, purity, phytomarker content for raw material and finished product absence of steroids and psychotropics, and bioactivity, and stability test certification, based on morphological, microscopical, physical, microbiological, chemical, safety and toxicity tests. Thus, pharmacognosy as a branch needs to be looked up as a vast area and is yet to be tapped into its full potential. A synergy between various academic, government and private research institutes can lead to development and commercialisation of useful molecules and products for cost effective therapeutic management with reduced side effects. u.sharma@expressindia.com

RENEWED INTEREST IN NEW COMPOUNDS Drug

Herbal source

Therapeutic use

Arteether

Artemisinin (Artemisia annua, sweet wormwood)

Malaria

Nitisinone

Leptospermone (Callistemon citrinus)

Tyrosinaemia

Galantamine

Galanthus nivalis (snowdrop or common snowdrop )

Alzheimer's disease

Apomorphine

morphine (Papaversomniferum)

Parkinson's disease

Tiotropium

Atropa belladonna

COPD

Dronabinol and Cannabidiol

Cannabis plant & Capsaicin

Pain Reliever

Capsaicin

Capsicum annuum

Pain Reliever

(

THE MAIN FOCUS

Through the teachers’lens As Teachers’ Day nears, four renowned and reputed educationists share their insights and vision to make pharma education future ready, with Lakshmipriya Nair

We need to upgrade ourselves How is NIPER, as a premier pharma education institute in India, encouraging adoption of industry best practices, providing intensive hands-on training, enabling compliance regulatory guidelines and ensuring high quality standards of medicines? The pharmaceutical sector holds the centre stage of the healthcare system in providing therapeutic agents for treatment of patients in various disease areas. While producing medicines at affordable prices to the citizens is an important aspect and the quality of the medicines is the most critical issue. NIPER S.A.S. Nagar works on both these aspects developing novel low-cost formulations as well as analysis of impurities in drugs. NIPER S.A.S. Nagar was envisaged and established with the very objective of providing leadership in pharma education and research. I am happy that we secured 1st position in NIRF ranking in 2018 among all the pharmacy institutes in the country. The Academic model of NIPER S.A.S. Nagar allows it to update its curriculum continuously as per recent advances in the field as well as the current requirements of the industry. The syllabus is based on an inter-disciplinarily approach and NIPER S.A.S. Nagar has been very much attentive to provide due support to the pharma sector in

imparting advanced level education and training to its graduating Masters’ and Doctoral students. Many of them have joined pharma industries within the country and abroad. The best practices as applicable to pharma industry are being inculcated through class room instructions by appropriate structuring of the courses of study. In addition to the structured curriculum, the students are free to attend audit courses. Apart from basic science courses, those with relevance to industry, are taught considering the regulatory requirements and hence ICH and FDA/ EMA/ WHO guidelines are regularly referred to during teaching. We have highly qualified and trained faculty, who have been working with, and even guiding and training the industry in understanding the national and international regulatory requirements. In addition to didactic lectures, the institute has created dedicated centres for advanced analytical techniques, impurity profiling, standardisation and profiling of herbal products, centre for regulatory toxicology, biopharmaceuticals etc. on which students get a chance of hands-on training during all semesters of their Masters’ programme. Small and Medium Pharmaceutical Industries Centre (SMPIC) of institute aims at creating commercial

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PROF. RAGHURAM RAO AKKINEPALLY Director, National Institute of Pharmaceutical Education & Research (NIPER)

synergy between industry and academia, and for furthering the spirit of cooperation. We also focus a lot on sensitising the students on the current difficulties being faced by industry in terms of audit inspections and issue of 483s and warning letters, and highlight the need for immaculate working and requirement of utmost integrity once they join industry. What are the steps needed to rejuvenate our pharmacy education system in India? Traditionally the pharmacy education in the country has been underestimated as the means to supply technical manpower to the pharma industry. This trend had been duly recognised by the peers (both from industry and

academia) of pharma education and research of the country that ultimately gave birth to NIPER S.A.S. Nagar. Thus the philosophy of education and research at NIPER S.A.S. Nagar is to build a strong knowledge base and impart technical skill to its students and scientists with due emphasis to the fundamentals in the areas of chemical, biological, and pharma disciplines so that the students passed out from NIPER not merely lend technical support to pharma sector, they are also groomed as the future teacher and leaders of pharma education and research and become thinkers and innovators. There is still dual control of pharmacy education by PCI and AICTE, though we see some progress in the two organisations talking to each other to resolve the issues. Also, often the voice is raised with respect to single ministry handling all the affairs related to pharmacy, including education. The clarity on these will come in due course. What is immediately needed is to be more stringent on quality of instructions and training being provided by institutions by having stronger regulatory framework. Apart from this, there is a need to realign the whole curriculum to include some of the newer topics that make part of 4th Industrial revolution. Our Prime Minister

Narendra Modi in his recent convocation address at IIT Mumbai exhorted the institutions to improve the quality of graduates and specifically mentioned that students need to be made aware of IT broadband technology, artificial intelligence, blockchain technology, big data analysis or machine learning. In addition, many other newer concepts like modeling and simulation, personalised/ precision medicines, automation and robotics, continuous manufacturing, six sigma, lean manufacturing, quality by design, process analytical technologies, etc. are already playing a big role in drug discovery, development and manufacturing. In addition, the regulatory landscape is changing every day and more and more stringent requirements are being put in place. Therefore, it is big responsibility of governing bodies to revise curriculum on regular basis, and even offer significant flexibility to good institutions to devise their own academic curricula to include cutting edge aspects. Can you elaborate on the role of pharma teacher-leaders in creating an innovative ecosystem? Practically, we have very few pharma teacher-leaders in the Continued on Page 23

EXPRESS PHARMA

September 1-15, 2018

cover ) Institutes need to create an ecosystem India Pharma Inc is on the brink of a huge transformation. What is the strategy shift that is needed in pharmacy education to accelerate the industry’s growth story? India has a major stake in global pharma market, which is achieved by supply of high quality product. Pharma industry in India is growing annually at more than 15 per cent. In the coming years, there will be demand for target specific formulations, biologics and biosimilars, nutraceuticals and generics. There will be mergers and acquisitions, stringent regulatory requirements, emerging new drug delivery systems, new technologies and instrumentation. API manufacturing to reduce dependence on other countries. There are two major domains of pharmacy education. One domain is known as ‘Industrial Pharmacy’ and the second one

is known as ‘Pharmacy Practice.’ Every educational institution that is imparting pharmacy education should be attached with one pharma industry and one hospital. The attached pharma industry will pave the way for transformation taking place in industrial pharmacy sector whereas the attached hospital will help in training the students on the area of ‘Pharmacy Practice.’ What is the role that premier pharma education institutes in India should undertake to create an innovative ecosystem for life sciences sector? When the Indian pharma sector is set for huge transformation it would require skilled and expert pharma professionals. To prepare industry ready pharma professionals pharma institutes have to play a very important role, they have to collaborate with major pharma industries

PROF (DR) NAVIN SHETH Vice Chancellor, Gujarat Technological University, Ahmedabad

to reframe syllabus to make it to match with the recent and future requirements. Pharma industries also have to actively participate in training the professionals. Indian pharma and healthcare system have many challenges. There is need to convert these challenges into opportunities through innovative solutions.

Present education should inspire students for innovative and creative thinking. To nurture innovative and creative ideas of students, institutes need to create an ecosystem which could help them to convert innovative ideas into products. Institutes should train teachers to inspire and motivate students to think out of box to find innovative solutions for problems in healthcare and pharma. How do we enable quality assurance in India’s pharmacy education? A two-fold approach is essential to ensure this 1. Institutions should be provided with greater autonomy. There is a greater need to do away with the current affiliation systems. Institutions should have autonomy to decide syllabus pedagogy, conduct examinations and award degrees.

2. Second important requirement is to allow private rating agencies to evaluate the performance of educational institutions. Such agencies can be established as per the regulations framed by the government. This two fold approach will ensure a spirit of healthy competition and transferring which in term will assure quality to all stakeholders. What is your message for your fellow teachers and the sector? All teachers should come forward to pursue Ph D and Post-Doctoral Programmes. They should try to apply for patent for their research work whenever possible and then they should try to publish their research work in a quality journal. Teachers should be updated and ready to match up with the recent and future requirements of the industry so that they can prepare industry ready professionals.

We should aim for more research output What is the strategy shift that is needed in pharmacy education to accelerate the industry’s growth story? The Indian pharma industry is globally well advanced and the country’s pharma education sector has contributed immensely to this growth by supplying qualified graduates who are highly skilled and trained. The research output is also good for the Indian pharma business. The pharma education sector has contributed to great extent for bulk drug production as well. The strategy shift required is to enhance production of bulk drugs and phytopharmaceuticals. Drug discovery programmes should also be strengthened through pharma education.

22 EXPRESS PHARMA September 1-15, 2018

We should aim for more research output with industry collaboration and partnership through the pharma education sector. Government funding agencies are required to give sufficient seed money and the industry should focus on contributing through BIRAC schemes. IITs will also be helpful for furthering the growth and progress of the Indian pharma industry, in the long run. The industry is talking about the creation of Quality Pharmacists by Design’ (QPBD)? What would this involve and what are the immediate measures that need to be taken by pharma educational institutes? Though Quality Assurance and

push regulatory and quality assurance programmes of eminent universities and IITs with industry collaboration and partnerships to enable the creation of quality pharmacists by design.

DR N UDUPA Professor and Research Director (Health Sciences), Manipal Academy of Higher Education

Regulatory PG programmes exist in a few institutions of India, the industry has not yet come forward. Through Drugs Control department, Health Ministry and ICMR, we have to

What is the foremost responsibility of a pharmacy teacher in the current times to create a productive learning environment? Though 1500 plus pharma educational institutes exist in India, the quality of teachers and leading researchers are lacking due to poor management support. There are hardly 50 institutions in India that provide quality pharma education with teachers pursuing research. Though several opportunities

for national, international grants are available, there are only few institutions claiming for the same. Pharmacy teachers should have more zeal for improved research output and quality upgradation. The teachers should motivate talented students and youth for higher research output and technological innovation. What is your message for your fellow teachers? We have to work hard to enhance our research output. We have to lift our quality output. We have to see that our talented students become innovative entrepreneurs. We must collaborate with foreign universities and industries. We have to raise our institutions’ eminence.

(

THE MAIN FOCUS

There is a need to revamp education system How should we revamp our pharma education to provide more emphasis on clinical and practical training, with a research oriented way of learning? Pharmacy education is like a free-flowing stream. The teachers have to facilitate its hurdle-free flow. What was relevant in pharmacy education four decades ago is irrelevant today and what is being taught today may be out of place tomorrow. In the past, pharmacy education in India was heavily loaded with pharmaceutical technology which was essential for creating human resources for our evergrowing pharmaceutical industry. The need of the hour is to revamp education system by strengthening the base of hospital and clinical pharmacy with a well drafted practical component to create the cadre of pharmacists who shall be capable of working with ease along with medical and paramedical professionals. To make Ayushman Bharat scheme and Janaushadi Kendras projects successful, we need disciplined cadre of pharmacists to cater to the healthcare system of our country. The course currently should not be merely theory

oriented. The institutions should establish strong linkages with health establishments in their vicinity to ensure effective training of the students in hospital and clinical pharmacy,as well as drug retailing. In a nutshell, we have to strike a balance to make our teaching both industry and hospital oriented with emphasis on practical training.

Continued from Page 21

discovery. This has been possible with collaborative efforts with national and international institutes as well as the biotech industry. Of course, the teachers in academic institutions, who shape the young minds, need to work hard to adopt innovation as a culture in institutions and encourage the same. There is a strong need to promote the culture of innovation. I am happy that NIPER S.A.S. Nagar has realised that the future lies in increasing the pace of

country today, who themselves have excelled and have helped in creating an innovative ecosystem in pharma sciences, and left a mark at the global level. The situation is same in the industry, where leaders are now realising that their further growth story will be complete only by inculcating innovation and quality. Faculty members of biological sciences have initiated many innovative projects in target identification and validation and drug

What are the strategies to promote and foster selfassessment and continuous quality improvement of pharma educational institutions? Pharmacy education has undergone rapid metamorphosis in last one decade. Number of institutions imparting Bachelor of Pharmacy have come up. There are more than 1600 institutions in our country of which many of them lack in adequate infrastructure of human resource and physical facilities. The mushroom growth of institutions has resulted in bringing down the academic standards. The institutions of higher learning in pharmacy have to be the epicentres of knowledge creation,

PROF CHANDRAKANT KOKATE Former President Pharmacy Council of India, Former Vice-President of Association of Indian Universities and Former Vice-Chancellors of Kakatiya and KLE Universities

knowledge dissemination and storage of knowledge. To strengthen this base of education, the components of self-assessment and continuing education are required to be introduced in pharmacy institutions. Internal Quality Assessment Cells of the Institutes should be proactive. An effective selfassessment scheme has to be evolved and implemented to ensure that quality education is imparted by the stakeholders of the Institutes.

innovation, and since I have joined, I have taken some concrete steps and have started the NIPER Innovation Award (NIA-2018) where faculty, staff and student community can submit their creative technological and design ideas in the form of a proposal. What is your message for your fellow teachers and the sector? To my fellow teachers in the pharma sector, I would urge that adopting a continuous

The accreditation of institutions by NBA and/or NAAC, the statutory bodies, should be made compulsory. To keep pace with the newer trends in pharmacy education, the teachers should regularly undertake continuing education programmes for self improvisation. There is urgent need to establish ‘Academic staff colleges’ in pharmacy for training of trainers in pharmacy. These colleges should be strategically located to cater to the needs of teachérs from different parts of the country. Can you give some international examples of good pharmacy education? How can we adopt their strategies and apply them to the Indian context? I visited some pharmacy institutions in USA, European countries like Germany, England and France, and South East Asian countries and interacted with the pharmacy teachers abroad. The practical teaching component in these institutions is very strong. The industry- institute interaction is real and not cosmetic. The teachérs and students are

upgradation of teaching methodologies/practices keeping pace with the global advancements is essential. We teachers in pharma education need to see beyond our narrow domains and holistically look into what our industry and profession expects from our output – the students. So every effort should be made for improving their quality by focusing on rightful education and training. Also, we shall simultaneously pay emphasis on skill development, which at

immensely benefited by the linkages with industry. The research in institutions is liberally supported by pharma industry. Most important thing I have witnessed is the accountability in research on the part of teachérs working on industry sponsored projects. I was impressed most with the academic environment prevailing in University of Chicago and University of Michigan in US, University of Muenster and University of Tubeingen in Germany and University Sains Malaysia in Malaysia. What is your message for your fellow teachers and the sector? A good teacher is a life long learner, a preacher of academic values, a precursor for professional synthesis, a motivator for his/her students, an educator par excellence and a role model for the students. As teachers we should be proud of our profession. We should thank Almighty for having given us this opportunity to serve in the field of education. This beautiful life we are all enjoying is God's one time gift to us. Let us all prove worthy of it.

present is largely poor. The students wish to enter the challenging future with a high degree of confidence, and expect that institutions prepare them for it. So we have a big role, and hence before we accept greetings on September 5th from our students, we need to take a resolve to upgrade and update ourselves in all possible ways.

Happy Teachers Day, dear colleagues! Jai Hind!

lakshmipriya.nair@expressindia.com To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

September 1-15, 2018

MANAGEMENT

Lupin’s Nagpur plant gears for future growth During a recent plant visit to Lupin’s Nagpur facility, Swati Rana in an interaction with Rajiv Desai, Executive VP - Corporate Quality, Lupin and Alok Ghosh, President - Technical Operations, Lupin, finds out about the latest technology and innovation implemented in the plant to make it future ready for the generic market

eeing an immense potential for growth of generic market in India, Lupin’s Nagpur facility is completely ready to compete and cater to the demands of generic drugs globally. The facility will be the largest with highest manufacturing capacity post its commercialisation. The plant manufactures both oral solid dosage (OSD) and injectables. Lupin has invested `753.12 crore in the plant, out of which `488.79 crore has been invested in OSD and `264.33 crore in injectables. The plant has completed four US FDA inspections, three inspections for product approvals and one on GMP compliance with zero observation. It is well equipped with latest technology and has error free documentation. The plant is expected to be fully operational from April 2019. Express Pharma tries to understand from Alok Ghosh, President - Technical Operations, Lupin and Rajiv Desai, Executive VP - Corporate Quality, Lupin, what makes this plant unique and different from its other plants. The company has looked after three essential parts i.e. compliance, cost and supply chain before designing the plant and made the plant future ready to deal with challenges in the generic market. Ghosh, while explaining the need to focus on these three parts says, “There are three essential parts that I look into, first is the compliance and when I talk about compliance it’s not the FDA alone but also environment safety. Next is cost focus. We are in a generic market and if we are not cost competitive and better than others in the market, we just can’t survive. The third being supply chain which is where we need to maintain our supply

24 EXPRESS PHARMA September 1-15, 2018

Rajiv Desai, Executive VP - Corporate Quality

chain to deliver the products on time in markets. So, looking at all these things, we have set up this plant. Going forward, the generic market would not be as easy as it looks and we want to keep ourselves ready and we should be able to compete in the market.”

Compliance challenges The facility aims to meet regulatory expectations and compliance challenges with its latest technologies, automation, innovation and less human inter-

Nagpur facility

vention. Desai gave a brief understanding on the issues faced during FDA inspection. He says, “Since we are into a highly regulated market, our sites get inspected on a regular basis. All our sites goes through FDA inspection every year. That’s the kind of audit frequency we face. Every year the audit expectation is different. Even if the products are old, the expectation of FDA are changing, so we have to gear up for that. Every couple of years, FDA comes out with new theme, one time it was data integrity, other time it was more of 21 CFR i.e. compliance, etc. so we have being trying to meet the FDA’s expectations.” Speaking on the current expectations of FDA inspectors, he further says, “The expectation of FDA nowadays is that they want to interact more to the people on site, as they are the one working day in and out on the site, analysing products. If they are the people on the site, they should be able to talk confidently to the inspectors.

don't need them. We have a simple way of working and we want to go ahead with that. So, we have to be alert about such kind of people and try to make sure that attritions are low, give them the confidence and space of working. That's a big challenge.”

About the plant Alok Ghosh, President - Technical Operations

We give that confidence to our people by allowing them to do their work correctly without being biased or without any apprehensions. The FDA inspectors are trained to inspect, they are trained for understanding body language, and face reading. So if someone is bluffing, it shows up in their gesture, that's where they get caught. For us there is no issue, we have created a friendly environment in the company and we try to nurture confidence in our employers working at any level in the company.” To deal with the current expectations of FDA, the company also recruits their employees carefully and train them to maintain the organisational culture and attitude. It has a dedicated technical training cell at Lonavala near Mumbai for organisational induction and other training. Desai says, “We are very careful in recruiting, we see what kind of experience and attitude they carry because that's how the culture comes in. We have to ensure that the same culture is maintained. We might have nurtured a good culture with the existing set of people, but if somebody comes from outside, if that person influences the way of working, brings in over smartness in work, then we

The Nagpur plant of Lupin is spread over total plot area of 1,073,557 sq. ft with dedicated units for OSD and injectable manufacturing. The facility has two blocks for OSD and one for injectable. The total build up area of block 1 is 1,17,394 sq.ft, block 2 is 4,63,131Sq.ft and injectable unit is 1,30,378 sq. ft. Like any other drug manufacturing plants, all the units of this facility have manufacturing area, packing area (primary + secondary) and quality control area. The plant is large in volume and well equipped with largest available capacity equipment.

OSD The OSD unit in the facility has closed process materials handling, separate floor for uncleaned/ cleaned equipment with automatic washing to reduce the contamination, dedicated AHU for each process area and automatic weighing and dispensing for all input materials with a total storage capacity of 7080 pallets. “As this is a formulation plant, we don’t have any effluent generated here. Even if some waste is generated, this is a zero discharge plant. We don’t discharge the waste outside, we recycle them in any possible manner. In terms of the safety to people, we ensure that the safety is maintained and the risk is minimal,” informs Desai. The company has also taken care of environment

health and safety by having double door emergency exit for each process area, fire protection systems: dedicated for fire hydrant and sprinkler, fire detection systems: Duct detectors, fire alarms & PAS system and zero waste water discharge. The manufacturing process operates with PLC / HMI, e.g. for rapid mixer granulator, fluid bed dryer, coating pans, capsule filing machines, bulk filling lines and blister machines. Quality control lab in the OSD unit is equipped with all sophisticated modern analytical instruments such as HPLC, HS-GC and Particle size analyser.

manufacturing records with a minimal manual intervention. The equipment captures process critical data online from sophisticated equipment directly into batch manufacturing record. The company has installed MODA: a software for paper-

less QC Micro data collection and management (Environment Monitoring, utility, and product testing). The software easily integrates with commonly used instrumentation and media found in manufacturing facilities, specifically production and

laboratory areas. It delivers timely and accurate QC monitoring by utilising locationbased scheduling, mobile data collection, and paperless lab processing. It is integrated with Laboratory Information Management Systems (LIMS) to bridge the communication

gap between QC and production. Once the facility is fully operational and the latest technologies works well, the other plants of Lupin might also go through the tech transfer for better productivity. swati.rana@expressindia.com

NEW

Injectables The injectable unit manufactures prefilled syringes, injectable vial filling â&#x20AC;&#x201C; liquid as well as lyophilised vials. All aseptic filling are handled in isolators. The company has installed an online system for monitoring of viable and nonviable particles and automatic loading and unloading system. The machines in injectable units consist of liquid line of vial washing machine, depyrogenation tunnel, vial filling machine, lyophilizer (10 Sq. Meter) and sealing machine. Microbiology lab is equipped with sophisticated modern equipment such as sterility test isolator, Vitek 2 compact, steam; steriliser, LAF, biosafety cabinet and incubators. Bioburden testing, water testing, endotoxin testing, sterility testing and all advanced testing available in pharmaceutical industries are tested in the lab here.

UV-1900

ICPMS-2030

UV-VIS Spectrophotometers

Headspace Samplers

UV-VIS-NIR Spectrophotometers

Thermal Analyzers (DSC/TGA/DTG)

FTIR Spectrophotometers

Spectrofluorophotometers

Atomic Absorption

Particle Size Analyzers

Error free documentation

Spectrophotometer

ICP Spectrometers

The USP of Nagpur facility that makes it different from the rest of its plant is error-free documentation. Electronic Batch Records Management System, which is being actively implemented in the Nagpur plant, will minimise the manual intervention in the work processes and human errors in the documentation. eBPR: Electronic Batch Records Management System maintains paperless electronic

Gas Chromatographs

ICPMS

EXPRESS PHARMA

September 1-15, 2018

GCMS / GC-MS/MS

NEW

Nexis GC + HS-20 NEW

FTIR IRSpirit

103, S. J. House, 1st Floor, Sitaram Mills Compound, N. M. Joshi Marg, Lower Parel, Mumbai â&#x20AC;&#x201C; 400011 Phone: +91.22.2301 5096 / 6450 7214 Fax: +91.22.2301 3592 Email: info@toshvin.com Website: www.toshvin.com CIN No. U33125MH2001PTC134376

MANAGEMENT I N T E R V I E W

India adopts proactive approach in adopting biosimilars to bring down cost Introduction of new drugs in the form of biosimilars will bring in new drug delivery system. The Indian pharma companies are focusing and investing considerable amount on research and development for bringing advancement as well as economically viable biosimilar drugs. With alarming incidences of cancer cases, biosimilar drugs for oncology will be majorly benefitted. Dr Piyush Gupta, Associate Director, GNH India informs about the proactive approach taken by the Indian pharma companies and its way forward to Usha Sharma How big is the global biosimilar market and at what per cent growth is it growing? Multiple sources that have studied this market predict varying growth rates and sizes of the market. Like any other new market that is at its nascent stage, the difficulty and ambiguity in prediction is always a factor. However, a safe assumption of the global market size would be around $100 billion with a CAGR of about 20 per cent. In India, the market could grow up to the $40 billion mark by 2030. This new form of the drug has a great untapped potential to change aspects of the pharmaceutical landscape as and when these biological drugs get approval. Developing biosimilars require huge and highquality research capabilities. While the Indian pharma industry is known for its generic capabilities, how do we fare in the biosimilars arena? Here in India, biosimilars are quite an established arena and have been evolving in leaps and strides over the

26 EXPRESS PHARMA September 1-15, 2018

In the process of making this drug affordable, which is one of the key features of the innovation, we have to heavily invest in biosimilars due to the lack of infrastructure and the novel services introduced while creating the biosimilar drugs

past decade. With a strong foundation and infrastructure and R&D in the generic space, India has the potential of being a top player in the biosimilar market. We are investing considerably in it, in the terms of both capital and efforts. The Indian pharma industry is learning and improving in biosimilars day by day showing the scope and enhancement of this sector in the country. However, there is a long road ahead for us to be a key player. The Indian pharmacopeia has yet to join forces with local manufacturers to develop bio-similars to reduce the cost of the drug in order to make it more available and easy to access to the populous. Another factor that will allow India to be a key player is our strong R&D facilities and talent acquisition. According to the Generics and Biosimilars Initiative (GaBI), the first â&#x20AC;&#x2DC;similar biologicâ&#x20AC;&#x2122; was approved and marketed in India in 2000, some 15 years before the US approved its first

biosimilar. Since then, how have we evolved and enhanced our capabilities? The world has evolved, but the US has adopted a slow pace approach, they are waiting for the world to adopt and they will adopt after there is considerable data available for biosimilars. India being a cost sensitive market, has adopted a proactive approach in adopting biosimilars to bring down cost. Give us five key challenges associated with the development of biosimilars drugs and what are the solutions for them? Cost: In the process of making this drug affordable, which is one of the key features of the innovation, we have to heavily invest in biosimilars due to the lack of infrastructure and the novel services introduced while creating the biosimilar drugs. Time: The process is stretched due to the hassles in the regulatory procedure and disruption in the process can be resolved by the increase in awareness of the criticality and importance of

MANAGEMENT

this arena. Availability of innovator drug for R&D trials: The trials are an important part of R&D. The innovator drugs undergo a lot of research and experiments to lead to an outcome of an effective biosimilar drug. Thus, there is a need for ready availability of the innovator drugs. The solution to this problem is to increase the accessibility of the innovator drug and give more impetus to the sector. Rigid regulations: The rigid regulations and the interference of the authorities in the procedure are quite profuse. The easing out of the process could help attract investment and development in the biosimilars sector. Cold chain: Cold Chain transportation is required at every step which is quite costly. The transportation of the drug, be it the innovator drug or the final product, needs cold storage. The need for cold storage transportation throughout the process of developing a biosimilar makes it a costly undertaking. Which therapeutic areas will gain from biosimilar drugs? How will it also drive growth in drug delivery systems? The therapeutic area that will majorly benefit by the biosimilar drugs is that of oncology. It ensures high quality and effective medication at a reduced cost for the benefit of therapy in the long run. The introduction of new drugs in the form of biosimilars will bring in new drug delivery system along with it thus advancing the existing drug delivery system in India and thereafter, the world. Will biosimilar drugs be economically viable for chronic ailments? Biosimilars are aimed at curing the patient. It is not a palliative care or a medium that can be used to prolong

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September 1-15, 2018

life. The affordability of the drugs makes it economically viable to ensure the complete treatment of the ailment. What support is the industry looking for developing this sphere

from the government? The major support that is needed by the government is the ease of the procedure in conducting trials. The regulatory framework and process time and time for approval at each stage need

to gain efficiency. What role will GNH India play in driving development in biosimilars? We have been in this arena for the past 12 years. Our

services provide the most crucial phase of the sourcing of the innovator drugs starting from candidate selection right up to the phase IV trials. u.sharma@expressindia.com

MANAGEMENT

Behind all the hype and hoopla about biosimilars Looking at the pipeline of biosimilars, India shall remain a major market for biosimilars. Dr Siddharth Dutta, Associate Vice President, Markets and Markets Research, gives a different outlook of the industry in 2018 ACCORDING TO a recent report by Seema Surendran (published in 2017) there are 70 approved biosimilar products in the Indian pharmaceutical market. Looking back at the history of biosimilars in India, GaBI (Generic and Biosimilars Initiative) claimed that the first 'similar biologic' was approved and marketed way back in 2000, however, there is a conception in the industry that Dr Reddy’s Laboratories are the pioneer of introducing the world’s first biosimilar antibody 'reditux' in the Indian market, in 2007. In the last 10 years, the market has seen companies such as Biocon, Reliance Lifesciences, Intas Pharmaceuticals, Zydus, Cipla, Aurobindo, Alkem Laboratories grow and there shall be many more to follow. As per the current trend, more and more Indian companies are tying up with MNC for FDA approvals and building equations to create monopoly (the western MNC keeps rights of sales in major market and Indian companies are picking up rest of the world markets). What could be the possible reasons? Does it bring more credibility in the market and FDA or is there something more to it? In January 2018, Biocon, a

may be much larger for generics than for biosimilars i.e. it may generally cost 15 per cent to 30 per cent less than the reference biologics, while the generics may cost upto 50 per cent to 90 per cent less than branded drugs. Whatever may be the case, biosimilars still have a long way to go in terms of opportunity, efficacy and acceptability. Hence there is no looking back.

Bengaluru-based Indian company tied up with Sandoz, the generic division of Novartis for a major alliance to develop, manufacture and commercialise multiple biosimilars in the segments of immunology and oncology. Companies such as Apotex (Accord Healthcare) has already partnered with Intas (to gain access to Intas’s biosimilar range) and market it’s product in the western world.

Manufacturers’ perspective on biosimilars and the risks involved

Industry’s perspective on biosimilars versus generics – Which is more profitable in long term? Before looking at the opportunity in the market, there are certain misconceptions that need to be cleared. India has a robust pipeline of non-innovator biologics which are not essentially biosimilars. The term can be misleading for some as they are often classified as biosimilars and share the same international non-proprietary names, but with some difference in their overall structure such as difference in amino acid sequence. Since these biologics do not always require a comparative clinical testing, at times it is difficult to compare the efficacy or if they are indeed biosimilar to the originator brand. As a part

of the Modi government’s initiative, subsidies are being offered to Indian biosimilar manufacturers. Till 2017, 40 biosimilars were in pipeline and counting. Some major MNCs have already partnered with Indian companies for joint R&D and long-term business. The overall investment that is required for biosimilars production ranges between $100-250 million versus $1-4 million for generics. The cost savings

If we take the bull by the horns and accept the fact that a biosimilar drug investment requires a bigger investment, then probably there will not be much takers in the market. But that is not the case, even though more than 80 per cent of the investment goes in clinical development and rest goes in the pre-clinical development of drugs. Still, there are enough risk takers in the market who are investing in this segment with the hope that the outcome from these clinical studies matches with the one from the originator. So, do they make money? Of course yes, companies such as Intas Biopharmaceuticals have reported double digit

growth (product side) and companies such as Syngene International (Biocon company) has reported high growth on the services side. In 2018, Cipla has more than $130 million dedicated funds for biosimilars research, Aurobindo has invested $80 million while companies like Dr Reddy’s are ready with their pipelines. Looking at the major Indian players Reliance Life Sciences has reported 14 biosimilars in pipeline and market, Zydus Cadila has 18, Biocon has six marketed and approximately 10 in pipeline (tie-ups with other drug manufacturers) and Intas Biopharmaceuticals has already marketed eight biosimilars in the India market.

Conclusion Are the biosimilars attractive or much hyped? Does collaboration ensure success or mitigates risk? Last year, CANMab won the status of biosimilars (originally introduced in 2014 as non-innovator biologics) for Biocon, a Bengaluru based company. Continuing the success wave, Biocon is all set to introduce 'Ogivri' or the ‘novel biologic” in 2018 and appears to be one of the most sought after and attractive companies for a tie-up

TABLE: RECENT BIOSIMILARS APPROVED/EXPECTED APPROVAL BY FDA (BY INDIAN MANUFACTURERS) Biosimilars

Company

FDA Approval/Expected

Launch

Innovator Brand/ Annual Sales

Trastuzumab

MYL 14010 Mylan Biocon (Indian)

2017

2019

HerceptinAnnual Sales$ 2,521 Million

Pegfilgrastim

MYL 140IH Mylan Biocon (India)

2018

Neulasta Annual Sales $4,112 Million

Grastofill

Apotex Intas (Indian)

2017

Pending

Neupogen (Filgrastim) Annual Sales $ 760 Million

Lapelga

Apotex Intas (Indian)

2017

2019

Neulasta (Pegfilgrastim) Annual Sales $ 4,112 Million

Rituximab

Sandoz

2018

2019

Herceptin Annual Sales $2,521 Million

28 EXPRESS PHARMA September 1-15, 2018

MANAGEMENT in India. Reliance Life sciences has purchased the global rights of biosimilars of infliximab from Epirus Pharmaceuticals. Zydus Cadilla is also collaborating with a Turkish pharmaceutical company to market and thus enter the Turkey market. Lupin has started focussing on biosimilars and complex generics in 2018. The Indian pharmaceutical market is all geared up for the next five years. Companies such as Hetero have recently launched (January 2018) a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market. Looking at the pipeline of biosimilars, India shall remain a major market for biosimilars. The segment has seen

As a part of the Modi governmentâ&#x20AC;&#x2122;s initiative, subsidies are being offered to Indian biosimilar manufacturers. Till 2017, 40 biosimilars were in pipeline and counting. Some major MNCs have already partnered with Indian companies for joint R&D and long-term business quicker approvals in the domestic market compared to others. Factors such as patent protection and discounted price are major drivers (in some case the rates are 50 per cent less than that of the originator brand). Gaps in the system or can the norms be just bypassed? The Central Drugs Standard Control Organisation (CDSCO) released a revised

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biosimilar guidance in 2016 for manufacturers in the biosimilars market. While the update was intended to make the process more quality driven (to reduce the residual risk of clinically meaningful differences between a biosimilar and its reference product through post-marketing studies i.e. collection of data through a predefined singlearm study conducted within two years of licensing) and ad-

ditional information with regards to reference product eligibility. This meant additional paperwork and delay for the manufacturers. Although the reforms are in place, there are several reports where companies have not strictly adhered to the norms and yet released their products. Quality or Cost â&#x20AC;&#x201C; What will you choose? Prescribers in India have

shown their liking for quality and outcome based result over price. However, that may not be the case if the patientâ&#x20AC;&#x2122;s affordability is taken into consideration. India shall remain a major market where out of pocket payment will continue to hamper the acceptability of biosimilars, unless, the insurance companies come forward or the CDSCO decides on heavily subsidising some of the new biosimilars under the essential drug list. India as a lucrative prescription market for biosimilars will still take time to bloom and the pace shall remain slow for the next two to three years. However, if you consider India as a home ground for R&D and manufacturing (especially contract manufacturing), it makes more sense to tie up with Indian manufacturers in 2018.

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MANAGEMENT

Good medicines come in quality packages In the third 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 throw light on the technological intervention in supply chain management that will ensure good medicines are delivered through superior and technologically -driven supply chain management

30 EXPRESS PHARMA September 1-15, 2018

magine a village in the desert of Rajasthan. In the scorching heat of 480 celsius, a baby is waiting for a vaccine. Of all the medicinal products to be sold and administered all over the world, the most difficult to manufacture, transport and store are the injectables. Whether they are vaccines and antisera of various kinds, high-end antibiotics, the growing range of biotech medicines and biosimilars, they have to be maintained within a narrow range of temperature and humidity. Maintenance of the ‘cold chain’ for vaccines as they travel from the manufacturing site to the far-flung areas across miles of deserts is often the reason for success or failure of many immunisation campaigns. Vaccines and biologicals have to be stored under very strict conditions of temperature and humidity, or else they may lose their efficacy. As the number of biotechnologybased medicines increase all over the world, these challenges are beginning to multiply. When a doctor prescribes a medicine, and we consume it, both parties depend on the pharmaceutical industry to ensure that the medicines reach the drugstore in a proper condition. Often pharma products travel immense distance, across continents, varying zones of temperature, humidity and a lot more. Storage as well as packaging become critical components of the supply chain. Packaging of today’s pharmaceutical medicines must be child-resistant yet easyto-handle for the elderly. Western countries are using glass or plastic bottles, to make the medicine more senior citizen

friendly. Packaging of syrups and liquid medication have to ensure that the consistency of liquid medicines are maintained throughout its effective life, that is until it passes the expiry date, and this partly depends on the choice of packaging materials. Often, special design elements are built into the labelling or the company logo on the aluminium strip, which can help to differentiate them from counterfeit products. A few years ago, Bilcare, based in Pune, introduced what it calls a non-clonable-ID, with the help of which the pharma company can ensure that only its authentic products move ahead in the journey towards the final consumer. The PwC Report titled ‘Pharma 2020:

Supplying the future Which path will you take?’ points out that by 2020, the ability to manage risk and compliance throughout the supply chain will be more crucial than ever before. While globalisation is increasing the risks, greater public awareness and more diligent enforcement are raising the bar. The Indian government recently passed a law mandating the use of trackand-trace barcodes on all drugs meant for export, with effect from July 2011, following reports that Chinese counterfeiters were selling fake medicines labelled ‘Made in India’ in several African countries Understanding this shift of emphasis from products to patient outcomes is critical: new development technologies that include formulations that are easy to manufacture; new manufacturing technologies including virtual engineering; process tomography and other such technologies transgenic engineering; and more importantly new distribution technologies such as cloud computing and special features such as bokode, will be able to deliver significant benefits to every stakeholder in the healthcare value chain. To summarise, whichever road pharmaceuticals take, they will need to get closer to patients, and technological intervention in supply chain management will ensure that good medicines are delivered through superior and technologically driven supply chain management.

Issued in public interest by OPPI Watch this space for the fourth in the KYP series- The Journey of the pill

RESEARCH UPDATES

Pfizer,Astellas revise two cancer drug trial protocols to speed up results Both trials are testing Xtandi in men with hormone-sensitive prostate cancer

rugmakers Pfizer and Astellas Pharma said they would change protocols for two late-stage trials testing prostate cancer drug Xtandi to speed up completion. The companies now expect the ARCHES trial to end late this year, ahead of the previously anticipated completion date of April 2020, and the EM-

BARK trial to complete by mid2020, earlier than the prior goal of March 2021. Both trials are testing Xtandi in men with hormonesensitive prostate cancer. Xtandi is already approved in the US to treat castration-resistant prostate cancer and brought Pfizer revenue of $171 million in the latest reported

quarter. Prostate cancer is the second most common cancer in men worldwide and over 164,000 men in the United States are estimated to be newly diagnosed with the disease this year, according to the American Cancer Society. Reuters

Mr. Rajib Baidya Zydus Healthcare Limited, Ahmedabad e-mail : rajibbaidya@zyduscadila.com

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RESEARCH

Moderate ‘bad cholesterol’levels tied Staying fit might cut to early death for healthy people glaucoma risk: Study Researchers examined data on 36,375 adults with no history of heart disease or diabetes and a low 10-year risk for events like heart attacks or strokes

HEALTHY ADULTS who don’t keep their LDL-C, or ‘bad cholesterol’ in check are more likely to die prematurely from cardiovascular disease than peers with lower cholesterol levels, a US study suggests. Researchers examined data on 36,375 adults with no history of heart disease or diabetes and a low 10-year risk for events like heart attacks or strokes. Most had levels of the type of cholesterol that builds up in blood vessels and can lead to blood clots and heart attacks, known as lowdensity lipoprotein cholesterol (LDL-C), below the threshold that usually leads doctors to prescribe cholesterol-lowering drugs. During the study followup period of about 27 years, 1,086 people died of cardiovascular disease and 598 died from coronary heart disease. Compared to people with very low LDL-C levels under 100 milligrams per deciliter (mg/dL) of blood, individuals with LDL-C levels ranging from 100 to 159 mg/dL had a 30 to 40 per cent higher risk of dying of cardiovascular disease. With LDL-C levels of 160 mg/dL to 189 mg/DL, people had a 90 per cent higher risk of death from cardiovascular causes. LDL-C levels of at least 190 mg/DL, which is where guidelines suggest statin use even for otherwise healthy people, carried 70 per cent greater risk. Compared to people with LDL-C levels below 100 mg/dL,

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people with LDL-C of 100 to 129 mg/DL died of cardiovascular disease about 1.8 years sooner and people with LDL-C of 160 mg/dL or higher died around four years sooner, the researchers calculated. “The biggest take-home message from this study is that it demonstrates that having a low 10-year estimate cardiovascular risk does not eliminate the risk posed by elevated LDL cholesterol or (other forms of bad cholesterol) over a course of a lifetime,” said lead study author Dr Shuaib Abdullah from University of Texas Southwestern Medical Center in Dallas and VA North Texas Health Care System. “Life-style interventions, such as avoiding diets high in saturated and trans-fatty acids, increasing fibre intake, maintaining ideal weight, and engaging in regular aerobic activity may lower LDL cholesterol and have been associated with improved cardiovascular outcomes,” Abdullah said by email. “In those individuals in whom LDL cholesterol or (other forms of bad cholesterol) remain elevated despite these interventions, statins may be considered after discussion with the health care provider about their risks and benefits,” Abdullah advised. Prescribing statins, or cholesterol-lowering drugs, to healthy people at low risk for death from heart attacks or

strokes has been controversial partly because these drugs were tested primarily in intermediate and high-risk groups, the study authors note in circulation. Research to date hasn’t offered a clear picture of whether statins can help younger, healthier people live longer. The American Heart Association and the American College of Cardiology advise against statins for low-risk individuals unless LDL-C levels are at least 190 mg/dL. These recommendations also urge doctors to discuss the pros and cons of statins with low-risk individuals who have LDL-C levels of at least 160 mg/dL. Based on the study results, these discussions should lead more low-risk patients to consider statins, the authors conclude. The study wasn’t designed to prove whether or how slightly elevated, but not dangerously high LDL-C levels might kill people, or if statins would reduce their risk of death. Still, the results suggest that more people may want to consider treatments to lower LDLC when it reaches 160 mg/dL instead of waiting for it to hit 190 mg/dL, said Dr Christie Ballantyne, coauthor of an accompanying editorial and chief of cardiology at Baylor College of Medicine in Houston. “Lipoproteins play a fundamental role in the disease process of (hardening of the arteries),” Ballantyne said by email. “The bad lipoprotein particles carry LDL and (other bad cholesterol) which gets into the artery wall and sets off an inflammatory process which not only leads to plaques and blockages but also causes the plaques to be unstable and rupture with blood clots than cause the artery to be blocked off leading to heart attacks and strokes.” Reuters

The study was not designed to determine whether or how exercise or physical fitness may directly influence glaucoma risk MEETING PHYSICAL activity guidelines and being physically fit may reduce the risk of developing glaucoma by 40 per cent to 50 per cent, recent research suggests. Among nearly 10,000 people in a long-term study, even those who exercised less than the recommended 150 minutes per week had a lower risk of glaucoma than those who were completely sedentary, the study authors note in the journal Medicine and Science in Sports and Exercise.

“Glaucoma is one of the most common eye disorders and causes of blindness, however, we don’t know much about how to prevent it,” said study coauthor Duck-chul Lee of Iowa State University in Ames. In glaucoma, the optic nerve becomes thinned. Current treatments aim to reduce intraocular, or inner-eye, pressure. Previous studies have noted that physical activity lowers that pressure. About half of Americans don’t meet the national physical guidelines of 150 minutes of moderate intensity aerobic activity and two days of resistance exercise each week, Lee noted. “It is important to promote physical activity to prevent glaucoma in addition to the benefits in preventing other chronic diseases such as heart attack, dia-

betes and cancer,” he said in an email. The researchers analysed data on 9,519 men and women at the Cooper Clinic in Dallas, Texas, between 1987 and 2005. Study participants had their weekly physical activity recorded and their cardiovascular fitness was measured with a treadmill test. Lee and colleagues found that 128 new cases of glaucoma occurred during the average six-year follow-up period. People who met physical activity guidelines had a 50 per cent lower risk of glaucoma than those who logged no leisure time physical activity during the week. In addition, people with the highest cardiovascular fitness results on the treadmill had a 40 per cent lower risk of glaucoma than those with the lowest fitness levels. Being both physically active and highly fit was tied to the lowest risk for glaucoma. “The magnitude of a 40-50 per cent reduced risk of developing glaucoma by being active and fit is surprising, (and) may be one of the strongest factors in glaucoma prevention besides aging,” Lee said. The study was not designed to determine whether or how exercise or physical fitness may directly influence glaucoma risk. Another limitation is that participants self-reported their activities, so researchers can’t be certain how much they actually exercised. “At the same time, every little additional bit of physical activity you do is beneficial,” said Dr Pradeep Ramulu, who directs the glaucoma division of Johns Hopkins Medicine in Baltimore, Maryland, and wasn’t involved in the study. Reuters

RESEARCH

Earlier onset of type 1 diabetes linked to greater heart risk,shorter life 27,195 individuals aged 18 years and older in the Swedish National Diabetes Register who had been diagnosed with type 1 diabetes were studied THE EARLIER a child is diagnosed with type 1 diabetes, the greater the risk of heart disease and a life shortened by as much as 18 years, a large study suggests. Experts had assumed those heightened risks were explained by kids living longer with the disease, but new analysis indicates that some other factor associated with onset in early childhood may also be involved, according to the report published in The Lancet. While having to live longer with high glucose levels probably has an effect, “there is also some evidence that developing diabetes younger is associated with a more aggressive form of type 1 diabetes,” said Naveed

Sattar, a professor of metabolic medicine at the University of Glasgow in the UK, who co-led the study. “We need more research to really investigate why younger diabetes is more damaging.” The type 1 version of the disease has a different cause from the type 2 diabetes mostly seen in adults, which is often related to obesity and sedentary behaviour. Type 1 diabetes is an autoimmune disorder in which the body attacks cells in the pancreas that make insulin. Nobody knows what sends the body’s own immune system attacking pancreatic cells, said Dr Erin Kershaw, Chief of Endocrinology, University of Pittsburgh Medical Center in Penn-

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sylvania, who wasn’t involved in the study. Sattar and his colleagues studied 27,195 individuals aged 18 years and older in the Swedish National Diabetes Register who had been diagnosed with type 1 diabetes and compared them with 135,178 age-matched people in the general population who did not have diabetes.

The researchers followed the group through medical records, with half of the subjects followed for at least 10 years, during which time 959 of those with diabetes and 1,501 people without diabetes died. People who developed type 1 diabetes before the age of 10 were more than four times as likely as their counterparts in the general population without diabetes to die of any cause during the follow-up period, and four times as likely to die of cardiovascular disease. Those with diabetes diagnosed before age 10 were also about 30 times as likely as counterparts without diabetes to develop heart disease and 31 times as likely to experience a heart at-

tack, overall. Among just the women with early-onset diabetes, those rates were 60 times and 90 times, respectively. In contrast, people who developed type 1 diabetes between the ages of 26 and 30, were about three times as likely as the general population to die during the follow-up, and about six times as likely to develop heart disease or experience a heart attack. The drop in risk with lateronset diabetes relative to non-diabetics also means that people with the youngest-onset disease were six times as likely overall as those who developed type 1 diabetes at an older age to have a heart attack, for example. Reuters

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PHARMA ALLY VENDOR NEWS

4 edition of Smart Industry Conference held th

The conference provided a deeper insight on various aspects such as digitisation in manufacturing, robotics, connectivity, technological trends and business-model transformation

ndian manufacturers are at the brink of a technological transformation that is changing the way one works and communicates with each other. While the manufacturing landscape is evolving rapidly, it is important for SMEs to learn and understand how global players are driving innovation, creating efficiencies and capturing value to thrive in a connected ecosystem. In this context, the Ethernet POWERLINK Standardisation Group organised the 4 th edition of the ‘Smart Industry Conference’, which was partnered by ABB India, Unlimit IoT- A Reliance group company, HyperThings and B&R Industrial Automation. The conference provided a deeper insight on various aspects such as digitisation in manufacturing, robotics, connectivity, technological trends and business-model transformation. It also addressed software aspects in connection with smart systems providing delegates with a thorough understanding of this pertinent subject. In addition, it also tried to answer questions such as what could be the easy and low risk path helping manufacturers adopt and harness technological change and tackling implementation challenges effectively. The conferences offered a mix of keynote address, technical presentations, panel discussions and demos, which looked at the different areas of building smart machines and factories. During the keynote presentation, Neeraj Singh,

34 EXPRESS PHARMA September 1-15, 2018

Highlight of the conference was a panel discussion on ‘Building smart machines and factories: concept to implementation’

Director - Management Consulting, KPMG Advisory Services said, “Technological disruption is an opportunity and not a threat. Digital transformation promises a remarkable change in the way manufacturers operate, with far-reaching effects on business and industry models.” He highlighted five key success factors for early adopters; start with performance, not with data or technology; strive to optimise per-

formance; there is no need of perfect data to get started; focus on RoI and paybacks and collaboration for success. This was followed by the presentations from, Alok Maheshwari, R&D Manager, BU Machine & Factory Automation, ABB India on ‘Factory of the Future and the robotic automation’ and Sameer Kudalkar, PFA Sales - Mumbai region, B&R Industrial Automation on ‘Role of Edge architecture enabling ‘Smart

Factories.’ Highlight of the conference was a panel discussion on, ‘Building smart machines and factories: concept to implementation.’ The panelists of the discussion were Venkatakrishnan K Technology and Digital Lead, ABB India ; Neeraj Singh Director Management Consulting, KPMG and Ninad Deshpande Head - Marketing, B&R Industrial Automation. The discussion was moderated by Pooja

Patil, Corporate Communication, B&R Industrial Automation. The discussion was themed around underlining the challenges faced by manufacturers while building smart machines and smart factories and, thereafter, designing a roadmap to achieve successful implementation. Detailing challenges, speakers’ stressed on the importance of changing mind-set of organisations while embracing transformation. The manufacturing

Delegates at 4th Smart Industry Conference

sector is going through a makeover and the industry, as a whole, needs to think of the next step in order to embark on their digital transformation journey. It also tried to urge manufacturers to identify the challenges which they face in their machines and factories and then base the next generation solutions around these challenges rather than implementing technologies just for the sake of implementing. This highly engaging panel discussion, which also involved audience who asked questions based on their experiences and observations, was followed by a presentation on the topic, ‘Role of Digital Transformation Roadmap for Manufacturing Enterprises’ by Narendra Saini, Head – Product Management, Unlimit; Open connectivity standards for Industrial IoT by Ninad Deshpande, Head - Marketing, B&R Industrial Automation. The audience understood the importance of open source communications for machine-to-machines and machine-to-cloud connectivity. They were convinced that all automation vendors should offer open communication in their devices, which will help them become vendor independent and achieve a vertical and horizontal connectivity. This was further emphasised by the presentation by EIMS India on ‘Open technologies for successful ERP to shop floor integration: A user perspective’ by Kamalnath M, VP solution management. EIMS have successfully integrated POWERLINK into their solutions for all real time deterministic shop floor communication and OPC UA for a controller to IT and cloud communication. These open source technologies have helped them achieve a seamless connectivity from sensors to the ERP.

With around 100 delegates from different industries, the conference provided the knowhow for building smart machines and factories, which spanned across various horizons of industrial automation, robotics, open connective and cloud With around 100 delegates from different industries, the conference provided the know-how for building smart machines and factories, which spanned across various horizons of industrial automation, robotics, open connective and cloud. This 4th edition of smart industry conference provided the delegates with not only advanced automation concepts but also successful implementations of these next generation technologies by Indian manufacturers. It helped delegates to chalk out a roadmap for their own implementation and making their installation smart and ready for Industry 4.0.

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PHARMA ALLY

Marinomed Biotech obtains EU-wide certification for new cold medication New combination reduces blocked nose without a pharmaceutical ingredient while simultaneously combating viral airway infections

VIENNA-BASED Marinomed Biotech has secured EU-wide certification for a new product: a nasal spray that allows the decongestion of the nasal cavity without employing a pharmaceutical ingredient and tackles viral infections of the airways at the same time. The groundbreaking combination is based on a formulation for which Marinomed has submitted a patent application. This would allow the company to use its patented agent Carragelose, which targets cold viruses, in such a combination. “With this certification our new product is marketable throughout the EU,” explained

All Marinomed products launched to date are effective against cold viruses. Their efficacy is based on Carragelose, a polymer derived from red seaweed with a special, clinically proven, efficacy against viral respiratory infections Dr Eva Prieschl-Grassauer, Founder and a member of the company’s management board, Marinomed. “This year we will launch the product in Austria — under the brand name Coldamaris akut — and in Switzerland.” As a result, Marinomed is set to further

expand its product range, which currently consists of five different products including nasal, throat sprays and lozenges, available in over 30 countries. All Marinomed products launched to date are effective against cold viruses. Their effi-

cacy is based on Carragelose, a polymer derived from red seaweed with a special, clinically proven, efficacy against viral respiratory infections. Carragelose traps cold viruses, stopping them from infecting mucousal cells. The polymer also soothes and

moistens the mucosa. A new formulation has been developed in Marinomed’s laboratories in order to optimise the efficacy of Carragelose with the addition of a decongestant effect based on increased osmolality. Instead of sodium chloride (NaCl), which also has an osmotic effect, a new formulation is used to retain the activity of Carragelose against viruses infecting the respiratory tract. Certification of the newly developed, innovative product for sale in the EU reaffirms Marinomed’s strategy of continuously product development. EP News Bureau

Novo Nordisk Pharmatech in agreement with Signet Chemical Corporation The agreement will lead to the distribution of pharmaceutical range of quaternary ammonium compounds to the healthcare industry in India, Bangladesh and Sri Lanka NOVO NORDISK Pharmatech has entered into an agreement with Signet Chemical Corporation for the distribution of their pharmaceutical range of quaternary ammonium compounds to the healthcare industry in India, Bangladesh and Sri Lanka. Harish Shah, MD, Signet commented on this new collaboration said, “We are pleased to be associated with

36 EXPRESS PHARMA September 1-15, 2018

Novo Nordisk Pharmatech which is the leading supplier of Quats to the pharma and biopharma markets. Novo Nordisk Pharmatech’s FeF Quats complement our existing portfolio of excipients used especially for ophthalmic, nasal and topical dosage forms.” Novo Nordisk Pharmatech manufactures Quats (Benzalkonium Chloride, Cetrimide

and Cetyl Trimethyl Ammonium Bromide (CTAB), including customised grade, in accordance with cGMP (ICH Q7) for active pharmaceutical ingredients which is the highest available quality standard. Their products comply with the latest pharmacopoeial standards and are extensively supported by CEPs, DMFs and a comprehensive package of regulatory and quality as-

surance documents. Their manufacturing site (Koege, Denmark) is audited by the Danish Medicines Agency and US FDA. “We are happy to work with Signet as our distribution partner for pharmaceuticals. Novo Nordisk Pharmatech’s FeF Quats products fit perfectly with Signet’s wide range of excipients enabling the

customers to take advantage of these synergies. We wish to give the best service to our customers and the local pharma team of Signet are experts in working with customers to support their product development,” says Steve Profit, Sales & Marketing Director, Novo Nordisk Pharmatech. EP News Bureau

PHARMA ALLY PRODUCTS

Gandhi Automations’clean room high speed doors a necessity BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which one can limit the amount of dust and dirt in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process. Clean rooms have become integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the doors which needs to be chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to be quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air perme-

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

ability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, 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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Advancing implementation of Green Chemistry in India’s burgeoning pharma API industry A two-day Conference & Exhibition on “Advancing Implementation of Green Chemistry & Engineering in the Pharma Industry” will be held on September 27 and 28, 2018 in Hyderabad, to accelerate the implementation of GC&E practices in Indian Pharma Industry FOR AN industry that is focussed on reducing the disease burden and improving the living standards of patients, it is ironic that pharmaceutical firms produce a higher ratio of waste per kilogram of product when compared to other process-intensive sectors. Given the complexity of the molecules that are used as active pharmaceutical ingredients (APIs) and the resulting complexity in the synthesis and purification needed to produce a given API, the pharma industry as a whole ranks low compared with other chemical sectors in its green practices. A widely used and established green metric is the E-factor, developed by Roger Sheldon, professor emeritus at the Delft University of Technology in The Netherlands, which evaluates the ‘greenness’ of a manu-

facturing route by its process efficiency (Table 1). The pharma industry as a whole has a high E-factor compared with other industrial chemical manufacturing segments. The E factor for bulk chemicals ranges from 1–5, and for fine chemicals, 550, but for the pharmaceuticals, the E factor ranges from 25-100. To improve the environmental profile of chemical

processes, a widely used roadmap for green chemistry is encompassed in the 12 Principles of Green Chemistry. These principles identify strategies for meeting goals of sustainability. An important tool for advancing green chemistry in pharma applications is sharing information on its use. Members of the American Chemical Society Green Chemistry Institute Pharma-

ceutical Roundtable (ACS GCIPR), which consists of several major pharmaceutical companies and suppliers, encourages the innovation and integration of green chemistry and green engineering in the pharmaceutical industry. The group reviewed 14 areas in assessing contributions in the applications of green chemistry in the pharmaceutical industry. In its review, the ACS

TABLE 1. THE E FACTOR Industry segment

Product tonnage

Oil refining

10 – 10

Bulk chemicals

10 – 10

Fine chemicals

10 – 10

Pharmaceuticals

10 – 10

E Factor (kg waste / kg product)

<0.1

<1-5

5 -> 50

25 - >100

GCIPR reviewed work in the following areas: solvent reduction or replacement; amide formation; oxidations; asymmetric hydrogenations; carbon-hydrogen activation; fluorination; biocatalysis; alcohol activation for nucleophilic displacement; FriedelCrafts chemistry; chemistry in water; continuous processing and process intensifcation; and supercritical fluid chromatography separations. The Indian pharma industry is emerging as a global supplier and manufacturing hub for low-cost manufacturing and R&D to the world’s top pharma MNCs. The ACS GCIPR member companies with their commitment to source pharma intermediates from an environmentally robust and sustainable supplychain, is willing to offer their years of expertise and experience on using of Green

THE STRUCTURE OF THE TWO-DAY CONFERENCE & EXHIBITION IS SHARED BELOW: Date

Events

Target audience

27th Sept.,Thursday

Pharma Leadership Summit - Economic Competitiveness and Environmental Sustainability of Pharma Industry through Green Chemistry.

Senior Management - MDs, CEOs, President,Technical Directors, CSOs, CTOs,VP / Head of R&D / Technology

27th Sept.,Thursday

Workshop on Bio-catalysis in Pharma API Industry.

Group Leaders, R&D Managers, Senior Scientists, Senior Chemists, Process Development Scientists

28th Sept.,Friday

Workshop on “Essential Tools & Techniques for driving Green Chemistry in the Pharmaceutical Industry”solvent selection and reagent selection guides, GC&E matrices, etc.

28th Sept.,Friday

Seminar on “Ready-to-Implement Environmental Solutions and GC&E Technologies”– Case-study presentations by solution providers/ Exhibitors from Industry and Research Institutes.

R&D /Production Managers, HSE Managers, Sustainability Head

27th & 28th Sept.

GC&E EXPO - Facilitating one-to-one interactions with relevant solution providers.

Open for all

38 EXPRESS PHARMA September 1-15, 2018

PHARMA ALLY The Indian pharma industry is emerging as a global supplier and manufacturing hub for low-cost manufacturing and R&D to the world’s top pharma MNCs Chemistry tools and techniques with the pharma industry in India. The ACS GCIPR have over the years, developed ‘green’tools that facilitate catalysing the implementation of green chemistry and engineering on an everyday basis. The Green Chemistree Foundation, serving as a not-for-profit organisation with the vision to bring forth technical know-how regarding green chemistry and engineering applications amongst the Chemical community, has been collaborating with the ACS GCIPR to co-facilitate subject-specific workshops and Technical Conferences for the Pharma – API and bulk drugs manufacturers of India, with the objective to bring forth ACS GCIPR’s expertise and collective efforts in developing GC&E tools and techniques. To deepen this initiative, and to accelerate the implementation of GC&E practices in Indian Pharma Industry, a twoday Conference & Exhibition on “Advancing Implementation of Green Chemistry & Engineering in the Pharma Industry” will be held on September 27

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and 28, 2018 at Hotel Avasa, Hi-tech city, Hyderabad. The structure of the two-day conference is primarily designed to bring about a comprehensive insight into green chemistry and engineering applications for the pharma industry, where-in the experts from ACS GCIPR will be deliberating on some of the most pertinent domains as required to accelerate the GC&E implementation in the pharma industry. The above five events to be held concurrently across the two days on September 27 and 28, 2018, is designed to address the requirements of diverse groups ranging from senior management, technology leaders, R&D scientists, production managers, EHS Heads, etc. To explore your company’s participation in this timely deliberation, write to malka.doshi@industrialgreenchem.com OR call at +91 22 2879 1835 / 1275. For online registration visit: http://greenchemistree.co.in/ Register.html

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HPTLC-MS: The third wave after LC-MS & GC-MS HPTLC-MS is a pre-cursor to GC or LC-MS. It is very flexible, simple and ultra-fast and also a zero-risk-to-instrument technique, extremely simple which needs negligible maintenance. Ramesh Naidu, Vice President, Anchrom Enterprises India, gives an insight EVER SINCE chromatography was invented, it has grown exponentially in analytical applications. Tremendous improvements have been made in the software, instrumentation and the separation media during the last few decades. Instruments controlled by software produced such high-quality results, that they were acceptable to the most stringent regulations and authorities. Older techniques like column/ paper/ thin layer chromatography were replaced by GLP compliant software-controlled devices. Detectors in chromatographs have a major role. All detectors, when invented, were qualitative in nature and later improved to quantitative ones. Initially there were universal detectors like TCD, FID, UV and then came specialised detectors like ECD, FID, ELSD etc. But the use of mass spectrometric (MS) detectors was again a quantum technological leap due to almost universal applicability, specificity, sensitivity etc. Triple quad MS was a further improvement over single quad MS. GC-MS chromatographs came into the scene around the 1980s and have been very popular. The high sensitivity was essential when high resolution, low sample quantity capillary columns were used. However, only a small percent of known compounds are volatile and so the rest have to be analysed by liquid chromatography i.e. HPLC or HPTLC. HPLC-MS chromatographs became commercially available later and exploded in popularity. As yet, not everyone is capable of using it for quantitative analysis on a routine basis. Routine quality control methods need to be rugged, simple and inexpensive and much sensitive as needed but not as much as

40 EXPRESS PHARMA September 1-15, 2018

possible. Over all GC-MS and LC-MS (and MS-MS) are at the peak of their popularity and will remain so for the foreseeable future, as the MS detectors become more compact, rugged and easy to use. HPTLC – MS concept was patented many years ago but commercial instrument became available in the last few years. But its advantages were quickly realised by analytical chemists. MS as a chromatography detector is extremely popular being the last mile solution. However, reaching the last mile, requires a carefully planned, expensive and slow journey for samples. Particularly so, when the sample matrix is complex. All samples that are to be analysed by GC-MS or LC-MS must be very ‘clean’ i.e. without matrix. Most often, samples must stand in queue for analy-

HPTLC MS Interface

Ramesh Naidu, Vice President, Anchrom Enterprises India

sis one after another and preferably contain known analytes. In the big industrial R&D or QC labs, it is common to find numerous GC or LC instruments, simply because they are excruciatingly slow and the whole chromatograph has to be in a straight jacket and able to analyse only one sample of one type at a time. In the same labs, only a handful of balances or titrators or IR/UV spectrometers are able to handle the same number of samples and that too with negligible running cost. Time has come to make HPTLC a primary technique. In developing countries, funds are an issue and therefore, buying multiple instruments, sometimes by the hundreds, is a big financial burden in terms of space, running and service costs, personnel, cost of analysis etc such huge invest-

ment does not add new capabilities! Being highly sensitive, GC or LC with MS can be easily contaminated and forced to shut down. Clean-up of samples for chromatographic analysis is time consuming, expensive, adds another step to analysis but is a must to minimise unwanted matrix components from reaching the detector, to get correct results. Most of the above problems can be eliminated very simply by using HPTLC-MS wherever possible.

Advantages of HP-TLC HPTLC analyses 50-100 samples analysed in parallel. It’s far more practical than HPLC. Any sample, known-unknown, with matrix can be chromatographed without clean-up and without fear of damaging the chromatograph because sample remains on the plate. Very simple to use, maintain, learn. No high pressure or temperature is involved. Chromatography procedure is done in independent steps. What is unique in HPTLC is that the chromatographed sample remains embedded on the plate and does not go to waste. Therefore, one can get loads of information of the stationary fractions using UV, visible and fluorescence; post chromatography derivatisation with multiple reagents each giving a unique information and all of these, capped finally by MS of (only) desired fractions. No chromatography technique gives so much information. In the early 1980s, HPTLC was already compelled to use PCs to handle so much data whereas GC and LC data could be handled by an ‘integrator’, a sophisticated calculator of graphics. 10 times cheaper to analyse yet 10 times more productive

PHARMA ALLY than HPLC, for the same investment.

Advantages of HPTLC-MS In HPTLC-MS, the fraction(s) of interest can be selectively fed to MS. No need for all the sample to go through. A typical cycle takes three minutes to obtain a MS from a HPTLC fraction. Any lab equipped with a stand-alone HPTLC with MS can obtain dozens of MS from different plates for different reactions/scientists/labs. Such a set-up is a must in any organic synthesis laboratory or Central Instrumentation Facility. A reaction mixture, for example, can be separated and MS of all fractions obtained in an hour or so!! This takes hours and days by HPLC. Fractions from herbal samples can be easily identified. Interface to elute fractions from a HPTLC plate to the MS is commercially available. It works with any MS, thereby enhancing the productivity of an existing LC-MS in a lab by 5-10 times. HPTLC-MS is thus a precursor to GC or LC-MS. It is very flexible, simple and ultrafast. It is also a zero-risk-to-instrument technique, extremely simple, needs negligible maintenance. Its ruggedness is legendary. HP-TLC is far more practical technique for everyday use, than HPLC, where applicable. HPTLC is highly underestimated by most analysts because either they look at it as manual TLC or instrumental TLC. That is incorrect. USP chapter 203 defined the procedure for HPTLC in 2015 and almost 99 per cent claims to HPTLC before that refer to instrumental TLC in which manual operations are replaced by the machines but chromatography parameters about sample application, chromatography development, evaluation are based on TLC of 1960s! No chromatographer, who does organics analysis, can be complete without a thorough knowledge of current practice of HP-TLC. Several Indian labs have adopted this technique.

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Virosil Pharma: ASwiss eco-friendly disinfectant Sanosil Biotech has pioneered the novel concept of eco-friendly fumigation in sterile areas SANOSIL BIOTECH, a Mumbai based company is the first company to pioneer the novel concept of eco-friendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine based disinfectants have been feared. Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, SunPharma, J&J, Abbott, Serum Institute, Dr Reddy’s, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, Reliance Life Sciences, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Virosil Pharma effectively protects critical surfaces that come in contact with pharma products. Manufacturing, filling, packing and storage areas; Instruments, equipment, water

tanks and pipelines – can now be pathogen free. What’s more, there’s no need to re-wash disinfected surfaces or instruments since H2O2-based Virosil Pharma safely decomposes into water and oxygen. The formulation has been tested in various reputed institutions in Switzerland, France, Germany, Australia and India.

MIC determination Method Based on modified BSEN1276 (antifungal), BSEN 1650 (antibacterial) Objective: To determine the minimum inhibitory concentration (MIC) of Virosil against standard microbial cultures.

Objective Test organisms: 1) Escherichia coli ATCC10536 2) Staphylococcus aureus A TCC6538 3) Pseudomonas aeruginosa ATCC9027 4) Candida albicans ATCC 10231 5) Aspergillus nigerATCC 16404

Inference 1.) The minimum inhibitory concentration of the disinfectant sample Virosil was determined at different concentra-

How effective is it? Even at low dosages,Virosil Pharma has the power of penetrating bio-film and killing the actual bacteria, thereby providing a long residual level of disinfection

How safe is it? Even at low dosages,Virosil Pharma has the power of penetrating bio-film and killing the actual bacteria, thereby providing a long residual level of disinfection

VIROSIL PHARMA For bacteria- free surface & Pipelines How does it compare to chlorine? Virosil Pharma is superior to chlorine since it imparts no taste or odour to the water and is highly effective at both hot and cold temperatures

tion – contact time combination and against five different standard microbial respectively. The Criteria for passing the MIC was chosen as > 5 log reduction in Bacterial counts (BSEN 1650) > 4 log reduction in Fungal counts (BSEN 1276) 2) Virosil was effective in inhibiting all bacterial and fungal cultures under study, at a contact time of 15 minutes and concentration of 5 per cent

How does it work ? H2O2 is a strong oxidising agent (more powerful than chlorine or chlorine dioxide).The oxygen separated from H2O2 destroys the biofilm, enabling the silver to help destroy any bacteria or virus.

comes the disruption problem because it is absolutely safe to leave it in the water. Better still, the longer it’s in the water, the better the results since it will attack the biofilms which harbour most of the bacteria populations. The company also offers a customised disinfection audit on its website;

Disinfecting biofilms using Virosil Pharma Virosil Pharma not only successfully penetrates bio-films and eliminates bacteria but also maintains a long residual level of disinfection in water tanks and pipelines. Using Virosil Pharma over-

www.sanosilbiotech.com Contact details Dev Gupta, CEO, Sanosil Biotech Warden House, 1st floor, Sir PM Road, Fort, Bombay 400 001 Tel No 022 22872295 / 43112700 / +919820016292 email: info@ sanosilbiotech.com

RESULTS TABLE 1- COUNT OF STANDARD CULTURE INOCULUM USED Standard Culture

CFU/ml

Log Value

S. aureus

400000000

8.6020

P aerugilosa

380000000

8.5797

E coli

370000000

8.5682

C.albicans

99000000

7.9956

A niger

88000

4.9444

RESULTS TABLE2- MICROBIAL COUNTS POST DISINFECTANT EXPOSURE IN CFU/ML Microbial Counts in CFU/ml

Microbial Counts in Log Values

Log Reductions

Virosil 5%

Test Organism 3 mins

15mins

30 mins

3 mins

15mins

30 mins

3 mins

15mins

30 mins

3 mins

15mins

30 mins

S. aureus

37000

1000

4.0338

5.6020

6.9030

4.5682

1.6989

99.99

99.9997

99.9999

P aerugilosa

75000

<10

3.7047

>8.5797

4.8750

<1.0000

99.9802

>99.999

E coli

42000

<10

3.9449

>8.5682

4.6232

<1.0000

99.9886

>99.999

C albicans

<10

>7.9956

<1.0000

>99.999

A niger

<10

3.9444

>4.9444

1.0000

<1.0000

99.9886

>99.99

Highlighted values indicate MIC achieved as >> 4 log reduction in fungal counts (BSEN 1276) 5 log reduction in Bacterial counts (BSEN 1650)

42 EXPRESS PHARMA September 1-15, 2018

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

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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.

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SLITTER COATING LINE

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LAMINATOR

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Technical Services SPECIAL STATIC CURRENT PASSABLE SIEVE

CADMILL SCREEN

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Having Seppic & Serdex at your side

TECA™ Titrated Extract of Centella Asiatica

Serdex

Safety

TECA™ manufacturer

Proprietary data Acute

since 1978

and Chronic doses toxicity

GMP certied

Reports 100.056 & 100.057

A Pharmaceutical Ingredient for Wound Healing and Venous Insufciency

Whole plant Ph Eur

Identity card

Support

Mutagenicity Reports 1429, 1483 & 1507

ASMF

INCI

Asiaticoside (and) Madecassic Acid (and) Asiatic Acid

Composition

40 % of asiaticoside, 60% of genins * * madecassic acid and asiatic acid

Oral and Topical

Sustainable sourcing

excipient expertise

from Madagascar

Full regulatory &

Ensure Traceability & Quality

Form

Powder

Indication

Wound healing, Venous insufciency

Route of administration

Topical, Oral

Recommended use

Topical: 0.1 - 1%; Oral: 60 mg to 120 mg daily

Regulatory Status

Marketing Authorisation, OTC, Medical Device

Regulatory Support

ASMF / EDMF

quality support

Protect Local Resources Commit to Sustainable Development

Diabetic Foot Ulcer (DFU) Chronic Venous Insufciency stages

Highly puried extract of Centella Asiatica

422 million of diabetic people worldwide DFU prevalence Worldwide 6.4% USA 13%

Asiaticoside

Major cause of co-morbidity and low quality of life

angwal 50

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Precede 85% of lower limb amputations

Asiatic Acid

Madecassic Acid

Contact for more information Gangwal Chemicals Pvt. Ltd. :

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BUSINESS AVENUES

EXPRESS PHARMA

To Advertise in

Business Avenues Please Contact: ■

Mumbai: Rajesh Bhatkal

■

09821313017 ■

Chennai ■ Bangalore: Rajesh Bhatkal

Ahmedabad: Nirav Mistry 09586424033 ■

09821313017 ■

Hyderabad: Mujahid

Delhi: Ambuj Kumar 09999070900

09849039936 ■

Kolkata: Ajanta 09831182580

September 1-15, 2018

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

September 1-15, 2018

BUSINESS AVENUES

To Advertise in

Business Avenues

EXPRESS PHARMA

HVA

Technologies Private Ltd.

Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Rajesh Bhatkal 09821313017 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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

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

Agency Division Bectochem Consultants and Engineers Pvt. Ltd.

FLEXIBLE WALL BARRIER TECHNOLOGY

Modern Process Equipment (MPE), USA - Chainvey

Flexible containment integrated with Sifter

Flexible containment integrated with Multi Mill

• Flexible wall barrier technology ideal for containment processes/dust free operations. • Available in MOC PU, PE and PVC anti-static for better compatibility with various solvents, SS scaffolding and Base tray for glovebag positioning & fitting. • Bespoke design and can be integrated with new and existing equipment/ process. • Ergonomic studies for better process understanding. • More visibility due to the transperent/ optical clarity of the glovebag. • System can be static / under negative pressure or positive pressure with AHU. • WIP (wash in place) arrangement for cleaning of the system. • Wide range of equipment can be integrated by using containment technology. • Applications: In API Industry - Weigh balance, reactor charging, Centrfiuge, Nustche filter, Multi Mill, Sifter & Pack off can be integrated with flexible containment system. In Formualtion R & D - High shear mixer, FBD, Blender, compression machine, auto coater, Blister pack can be integrated with Flexible containment system. • Possible OEL validation can be perfomed in Flexible isolator .

September 1-15, 2018

GL Filtration Limited - World Leader in Solid- Liquid Seperation

Efficient Agitator System Metal Detector from Viscojet, Germany and Separator

Industrial & Chemical Compactor

Contained Tablet Press

Bectochem Consultants and Engineers Pvt. Ltd. Building 5C/204, Mittal Estate, Andheri-Kurla Road. Andheri(E), Mumbai-400059, India Tel: (91) 22-39277900/ 28500008/ 657018999 Fax: (91) 22-28506785 Email: fitz@bectochem.com Website:www.bectochem.com

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

September 1-15, 2018

BUSINESS AVENUES

September 1-15, 2018

EXPRESS PHARMA

PHARMA LIFE APPOINTMENT

Ajay Bhatt joins Intas Pharmaceuticals as the Global President for HR Apharma industry veteran,Bhatt brings with him more than two decades of HR leadership experience

ntas Pharmaceuticals, an Indian pharma company, has appointed Ajay Bhatt as President-Global Human Resources to spearhead HR for its complete global portfolio consisting of India, Europe, the US and emerging markets. Bhatt says, “I am inspired by its values, simplicity, agility and above all the leadership team of Intas. I look forward to partner in growth and leadership of this fantastic organisation”. “An exceptional peoples’

leader, Ajay’s unparalleled sectoral expertise in pharma, along with his unique blend of experience in large global and Indian majors, will be invaluable for Intas at this stage of their growth,” says Shailja Dutt, Managing Director, Stellar Search, the firm responsible for Bhatt’s placement with Intas. A pharma industry veteran, Bhatt brings with him more than two decades of HR leadership experience with some of the most respected names in Indian and global

Pharma, his last role being Director HR-Innovation & Development with Abbott Laboratories based out of Basel, Switzerland. He has previously been associated with leading Indian pharmaceutical majors including Sun Pharma, Zydus Cadila and Torrent Pharmaceuticals. Bhatt is a Masters in Social Work in the field of Personnel Management from Maharaja Sayajirao University of Baroda. EP News Bureau

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

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

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India. Board line: 0120-6651500. Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com

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

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

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

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

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

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

66 EXPRESS PHARMA September 1-15, 2018

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