Express Pharma (Vol.13, No.19) August 01-15, 2018 by Indian Express

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CONTENTS Vol.13 No.19 August 1-15, 2018 Chairman of the Board Viveck Goenka

IN THE QUEST OFTRUE FREEDOM

MARKET

Sr Vice President-BPD Neil Viegas Editor

As India gears up to celebrate its 72nd Independence Day, we examine a few factors which will be crucial to liberating the true potential of our pharma industry | P18

Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana New Delhi Prathiba Raju DESIGN

DELHI HOSTS HEALTHCARE SENATE, THE RADIOLOGY AND IMAGING CONCLAVE

IDMA AND NSF COLLABORATE TO CREATE CHANGE AGENTS OF QUALITY EXCELLENCE

P16: INTERVIEW

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

MANAGEMENT

PHARMA ALLY

Sanjeev Gupta MD, Kusum Group of Companies

Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

FIX DAVA PORTAL, SAYS INDUSTRY TO DGFT

OPPORTUNITY FOR BIOTECH FIRMS TO PURSUE DRUG CANDIDATES TARGETING METABOLIC DISORDERS

Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet )

B&R CELEBRATES 20 YEARS OF GROWTH AND INNOVATION WITH CUSTOMERS

WATERS BOLSTERS MASS SPECTROMETRY IMAGING PORTFOLIO WITH ACQUISITION OF PROSOLIA’S DESI TECHNOLOGY

PALL CORPORATION, BIOSCIENCESCORP LAUNCH STRATEGIC PARTNERSHIP

GERRESHEIMER EXTENDS BUSINESS MODEL IN OEM FOR DRUG DELIVERY PLATFORMS

Dhaval Das (Web Developer) Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

RESEARCH

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

PHARMA LIFE

EISAI-BIOGEN TO ADVANCE ALZHEIMER'S DRUG, PROVIDE FRESH HOPE US FDA APPROVES KRINTAFEL FOR RADICAL CURE OF P. VIVAX MALARIA

General Manager

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

EXPRESS HEALTHCARE ANNOUNCES BEST HOSPITAL PHARMACY CITATIONS 2018

BR Tipnis Manager

Express Pharma®

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

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

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August 1-15, 2018

EDITOR’S NOTE

Will indigenisation, innovation and information lead to true independence?

n my Editors Note in last year's Independence Day special issue, I had asked: as we mark our 71st Independence Day this August 15, how far have we progressed on the medicines security front? (http://www.expressbpd.com/pharma/ editors-note/india-pharma-incs-tryst-with-destinycontinues/388906/) Unfortunately, a year later, the reply is not very encouraging. As part of our Independence Day special coverage this year, we asked experts to explore strategies to improve our performance across three markers: indigenisation, information and innovation to accelerate Indian Pharma Inc's growth trajectory. While the Chinese government continues for the sixth year running to close down pharma companies which have been polluting the environment, prices of key starting materials and active pharmaceutical ingredients (APIs) sourced from China have become more expensive. More recently, the Chinese premier Li Keqiang has ordered a detailed investigation into how a Chinese vaccine maker, Changchun Changsheng Biotechnology, had got away with shoddy manufacturing practices and had sold some 252,600 substandard DPT vaccines to the Disease Prevention and Control Centre of Shandong Province. While no child who had been administered the vaccine suffered any adverse effects, the government was provoked into taking action after social media and even governmentcontrolled newspapers criticised it for ‘lax supervision and light punishment’ meted out to the country's pharma sector. These are echoes of the situation here in India as well though the CDSCO and regional teams have stepped up raids on companies making drugs without the Drug Controller General (India) (DGCI's) permission, especially irrational fixed dose combinations (FDCs). The net once again seems to be closing around FDCs. One of the topics on the agenda for the 80th meeting of the Drugs Technical Advisory Board (DTAB) sub-committee due on July 25, is the decision on 349 (344+5) FDCs. The DTAB sub committee has recommended that 343 FDCs be prohibited and six others be either restricted or regulated for specific indications or quantities. After discussions during the meeting, this report is likely to be sent to the health ministry in the next two weeks, following which the government will decide the fate of these FDCs. While industry will once again raise protests as they did in the past, this time they cannot say that they did not get a fair chance to present their case.

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But can one country’s regulations be truly independent of global regulations? India’s track and trace norms continue to have key differences from global norms. This has already negatively impacted pharma exports from India

The sub committee's decision comes after as many as 41 meetings with co-opted experts. All India Drugs Action Network (AIDAN) made 812 representations for 184 FDCs, while 467 companies had hearings for 156 FDCs. The sub-committee had reportedly found that “most” of the companies appealing the ban had not generated safety and efficacy data of their own for their FDCs. Almost 95 per cent of these appellants is said to have failed to prove safety, rationality and compatibility of these FDCs. The sub committee said that the published literature provided to justify the FDCs was “not relevant” (no epidemiological data from India, meaning the data was not of patients in India) and relied on a few “biased” studies. Indications mentioned were "too broad/absurd/vague" and were not as per treatment guidelines. The sub committee found that for most FDCs, their use would lead to “unnecessary overuse and the patients would be exposed to the risk of multiple ingredients when one would suffice.” The sub committee has specifically countered the claim to safety by referencing OTC products in other established markets like the UK or US, by pointing out that such appellants ignore the lacunae in the OTC system, label requirements of OTC products (e.g. not for children under 12 years of age), lack of efficacy and withdrawal by innovator of some products. For appellants who wished to change indication and/ or carry out studies in support of their respective FDCs, the sub committee advised them to follow D&C Act for new drugs. But can one country’s regulations be truly independent of global regulations? India’s track and trace norms continue to have key differences from global norms. This has already negatively impacted pharma exports from India. India’s pharma exporters grapple with differing definitions of packaging levels and data security concerns. The Directorate General of Foreign Trade (DGFT) has announced yet another extension to comply with requirements, but the industry argues that it needs to review its system to be more in sync with global norms. Thus, finally in our 72nd year of Independence, will our pharma regulatory mechanism prove to be independent enough to stand its ground? At least on the FDC issue, for starters? We hope to have the answer in our next issue, which will be the second in our Independence Day series. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET POST EVENTS

Delhi hosts Healthcare Senate, The Radiology and Imaging Conclave Leaders and game changers in India’s private healthcare sector came together at events organised by Express Healthcare to converse and contemplate on vital issues shaping the future of their industry

rganised by Express Healthcare and The Indian Express Group, Healthcare Senate – India’s largest private sector healthcare business summit, held from July 12-14, 2018 at Radisson Blu, Delhi Airport is a platform

which offered ample opportunities for all this and more. The three-day summit saw several leaders and game changers of India’s private healthcare sector come together at its third edition to converse and contemplate on vital issues shaping the

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(L-R) Dr Vishal Beri, CEO, Hinduja Surgical, Dr Sabahat Azim, CEO, Glocal Hospitals, Rajit Mehta, CEO, Max Healthcare, Dr Harish Pillai, Group CEO, Aster Medicity, Rupak Barua, Group CEO, AMRI, Kolkata, Sanjay Prasad, President & CEO,Mission of Mercy Hospital & Research Centre, Dr Gaurav Thukral, COO, Healthcare @Home, during the panel discussion on Business Culture: Why core values matter?

future of the healthcare industry, with a focus on the theme Healthcare 2.0: Strengthening Values for Sustainable Growth. On one end, veterans like KM Cherian, Chairman & CEO, Frontier Hospitals spoke on the rapidly changing healthcare landscape and highlighted how medical technology, emergence of ICT, expanding network of World Wide Web, social media etc., are disrupting and transforming

healthcare delivery. At the other end, innovators like the teen prodigy Akash Manoj, who has invented a very simple device which can detect silent heart attacks and save thousands of lives, took the stage to enlighten the audience about the importance of outof-the-box thinking and a solutions-oriented mind set in enhancing healthcare delivery. Interesting panel discussions saw

stakeholders of the industry share the stage to devise strategies for future growth. For instance, two of them, titled ‘NHPS: The way forward’ and ‘Access strategies in the era of price control’, saw eminent panelists discuss on the impact of initiatives such as Ayushman Bharat on the private healthcare sector, importance of all stakeholders collaboration, and approaches to remain profitable and sustainable in these times. The event also witnessed very interesting dialogues between leading CEOs of the healthcare industry. They addressed why core values matter in building a successful business. Growth strategies like consolidation and sustained innovation were also deliberated upon at Healthcare Senate 2018. The discussion on consolidation in healthcare focussed on how the strategy can help companies grow faster and benefit consumers in a better way. Crucial topics such as tackling financial risks and supply chain transformation were discussed at Healthcare Senate 2018 as well. Leading CFOs and financial experts, on the panel discussing financial risks, pointed out there are several uncertainties in the healthcare market today. Panelists discussing supply chain transformation, among other aspects, accentuated that healthcare organisations should pay attention to details and ensure that each link in the supply chain such as identification of the right product, vendor identification and evaluation etc., is functioning properly to bring in better efficiencies in supply chain management. This year, the audience at Healthcare Senate also gained insights from well known speakers such as Sanjeev Saxena, CEO, POC Medical Systems and Dr Renuka David, TedX Speaker, Author and Wellness Coach. Dr Mickey Mehta, India’s leading health and fitness guru also addressed the health professionals in the country and stressed that doctors should pay adequate attention to their own health as well. Policymakers like Satyendra Jain, Minister of Health, Government of Delhi; Ashwini Kumar Choubey, Minister of State,

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Satyendra Jain, Minister of Health, Government of Delhi on Day 1 of the event

Dr Vinod Paul, Member, NITI Aayog, giving the valedictory speech

MARKET MoH&FW, Government of India; and Dr Vinod Paul, Member, NITI Aayog graced Healthcare Senate with their presence on different days as Chief Guests and Guest of Honour. They chose this as a platform to inform about the various measures being undertaken to improve healthcare quality and access in the country. The partners of Healthcare Senate also came forward at the event to address the august audience and keep them updated about their solutions and services for the hospitals. The event also honoured the pathfinders, game changers and front runners in this industry through Express Healthcare Excellence Awards 2018 and Best Hospital Pharmacy Citations 2018 for their invaluable contributions to healthcare in India. Stay tuned to know about the winners of these awards. Concurrently held with Healthcare Senate was The Radiology and Imaging Conclave with a vision to brace the radiology fraternity for future developments within the sector. The conclave was organised by Express Healthcare and the Radiology Education Foundation. The conclave drew the best minds in the field of diagnostic imaging to congregate and discuss on the future of radiology. The two-day summit saw several leaders of India’s diagnostic imaging sector and medical technology providers come together to converse and contemplate on key drivers shaping the future of radiology. The Theme of the conclave was ‘Radiology 2023’. Industry veterans such as Dr PK Dash Sharma, Head , Radiological Safety Division, Atomic Energy Regulatory Board (AERB), Dr Bhavin Jhankaria, Chief Radiologist, Picture, Dr Arjun Kalyanpur, Chief Radiologist, Teleradiology Solution, Dr Sumer Sethi, Founder, DAMS & Telerad Providers, Dr Bharat Agarwal, Head of Radiology, Max Hospitals, Dr K Mohanan, IRIA President, Dr Pranshant Warier, CEO, Qure.ai, Dr Vidur Mahajan, Associate Director and Head of R&D, Mahajan Imaging, Rohit Sathe, President, Philips Health Systems, Vivek Kanade, CEO, Siemens Healthineers, Dileep Mangsuli, Chief Technology Officer, GE

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(L-R) Yogesh Patel, CFO, HCG Group, Ravi Bhandari, Strategy Consultant- Healthcare Services & Ex-CEO, Shalby Hospitals, Dinesh Mittal, CA and Financial Expert, Sumit Agarwal,VP Finance, Cloudnine Hospitals, Anupam Verma, President, Wockardt Hospitals, Dilpreet Brar, CEO & MD, medECUBE, during the panel on Financial Risk management: What healthcare organisation need to learn?

(L-R) Dr Aniruddha Malpani, MD, Malpani Ventures, Gauri Angrish, Founder & CEO, Caredose, Vidur Mahajan, Executive Director, Mahajan Imaging, Nachiketas Nandakumar, Assistant Prof, Great Lakes Institute of Management, Chennai, Subi Sethi, VP- Business Excellence, Optum Global Solutions, Dhruv Pandey, Leader Healthcare,Tata Trusts’Foundation for Innovation and Social Entrepreneurship, during the panel on Growth agenda: The battle for sustained innovation leadership

(L-R) Dr Sujit Paul, MD, Sarvagun Ausadhi, Gaurav Agarwal, Director, Singhi Advisors, VP Kamath, Group COO, Pinnacle Cancer Centres- India & International, Dr Ravindra Karanjekar, Group CE0, Jupiter Hospitals Dr Priti Nanda, Founder of Medi-skool/Co-founder of AB Hospitals, during the panel on Consolidation in healthcare: Putting the best foot forward

MARKET Healthcare, South Asia, Pankaj Tandon, AERB, Dr Nobhojit Roy, national Advisor, NHSRC, Tishampati Sen, Advocate, Supreme Court, and many more deliberated on subjects ranging from Al in radiology, policies and regulations, business models, education and patient care techniques that are key to the future growth of the sector. Informative panel discussions saw leaders debating on various technical and business related challenges faced by radiologists. For instance, the panel discussion on AI in radiology touched upon how radiologist can facilitate in creating an ecosystem for AI. The panel discussion on teleradiology and its future brought to light that teleradiology is uberisation of radiology. It will give us increased global reach and scope for greater subspecialisation as well as drive education in radiology. Similarly, the panel on changing needs for education drew attention to the need to redefine the classroom. It is a top choice for aspiring doctors. Panelists in this discussion brainstormed on how doctors are seeking wider impact, selecting macro over micro opportunities, looking to be entrepreneurs, innovators and researchers. The panel discussion on ‘Is radiology a viable business?’ brought to light several challenges that radiologists face in building and sustaining a radiology business. The event also witnessed some interesting dialogues between leading radiologist, policy makers and equipment leaders on the next big thing in radiology and the big brother debate pointed out the need for better governance in radiology and value systems that need to be revised in order to build patient trust. The event also honoured the radiology heroes, game changers and front runners in this industry through Express Medical Imaging Awards 2018 for their invaluable contributions to healthcare in India. Stay tuned to know about the winners of these awards. Thus, the two days of the Radiology and Imaging Conclave 2018 witnessed great exemplars of excellence, experience, innovation and knowledge. Stay posted on our print coverage in Express

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Healthcare’s issue for the month of August 2018 to know about each session in detail and also http://www.expressbpd.com/hea lthcare/ for extensive online coverage (Compiled by Lakshmipriya Nair, Raelene Kambli, Usha Sharma and Sanjiv Das)

(L-R) Rahil Shah, Director, NM Medical, Dr Avinash Nanivadekar, Chief Radiologist, Ruby Hall Pune, Dr Bhavin Jankharia, Chief Radiologist, Picture This by Jankharia, Brijesh Suneja, MD, Phantom Healthcare, Dr Sanjeev Mani, Senior Radiologist, Mumbai, Dr Uday Patil, Head of Radiology, Aster DM Healthcare during one of the panel

MARKET

IDMAand NSF collaborate to create Change Agents of Quality Excellence Conduct a certification programme for 40 valedictorians who have completed the nine-month course in quality management and advise them to put the learnings they have received into practice Viveka Roychowdhury MORE THAN 40 pharma professionals became Change Agents of Quality Excellence after completing the nine-month long Advanced Program in Pharmaceutical Quality Management (APPQM) offered by IDMA, in collaboration with NSF Health Sciences, UK. It is hoped that the MBAstyled programme, conducted at Acharya Institutes, Bengaluru over five modules of four days each, will create a cadre of Change Agents for Quality Excellence, who will endeavour to raise the bar for quality compliance within their companies. The long-term goal is to grow this community across companies to help rebuild the reputation of Brand India Pharma. In his welcome address at the certification programme, SM Mudda, Chairman, Regulatory Affairs, IDMA and Program Director, APPQM went through the components of the course. He urged the valedictorians to “convert quality into a management function and work beyond regulatory compliance for patient safety.” Speaking about the highlights of the past year, Martin Lush, Vice President, NSF Pharma, Biotech and Medical Devices spoke about the transformation of the participants over the past year into confident quality management professionals. He urged the valedictorians to keep in touch with one another through the alumni group that would be set up, because he warned that their hard work had just started. “This is just the end of the beginning,” he said. All participants who shared the learnings of this course during the valedictory function emphasised how their initial

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The first batch of IDMA- NSF APPQM Certified professionals

Guest of Honour Dr K Bangarurajan, Jt Drugs Controller, India speaks at the valedictory ceremony

scepticism changed into self belief once they could measure the success and RoI of their learnings. Many of the concepts discussed during the course were implemented at their work places during the duration of the course and formed part of their final assessments. SV Veeramani, Immediate Past national President, IDMA and CMD, Fourrts (India) Labs, too reinforced this message and urged Mudda and Lush to continue the efforts, with the next series to start in September. “We need to add to this community, so that they can achieve critical mass as fast as possible. Only

then can we see a visible change in the Indian pharma industry.” The course has received the backing of more than 30 pharma companies, who sponsored the 40 odd delegates. Ranging in size from $4 million to $4 billion, these companies should be complimented for taking a chance on an untried course, pointed out Veeramani, who has sponsored attendees from his company as well. Today, these companies are already seeing the benefits as their staff implement the learnings within their companies. Speaking as both a patient

and a journalist, Viveka Roychowdhury, Editor, Express Pharma, the media partner for the event, reminded the valedictorians to be always aware of the responsibility that they carried. As change agents, they are now expected to translate what they have learnt in the classroom into their daily work lives. Guest of Honour Dr K Bangarurajan, Joint Drugs Controller, India gave an update on the initiatives of the CDSCO over the past few years to improve quality. While appreciating the efforts of IDMA and NSF, he also congratulated the delegates on successful completion of the course.

Guest of Honor His Excellency Stephen Borg, High Commissioner of Malta spoke about the areas of common strengths between India and Malta, saying, “Malta has a long tradition of providing medical care. In fact, we have been known traditionally as the ‘nurse of the Mediterranean’ . Praising the Malta-based unit of Aurobindo Pharma as a successful example, he informed the audience that more and more Indian pharma companies are considering Malta as a reference member state for the EU and to base themselves to be closer to the EU and North Africa. He appreciated IDMA’s efforts to bring an NSF level certification program to India, concluding that “There are many bright spots in the Indian pharma industry. We need them to become brighter.” The valedictory ceremony continued with the distribution of certificates to the successful students. Giving the vote of thanks, Dr Diwakar Goli, Campus Director, Acharya Institutes, Bengaluru urged the valedictorians to continue to practise what they have learned as ‘practice makes perfect’. viveka.r@expressindia.com

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

GLOBAL PACK 2018

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

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

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

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

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Kusum Healthcare is growing geographically as well as product wise Sanjeev Gupta, MD, Kusum Group of Companies, opines that there is a need for increasing awareness among medical practitioners about the benefits of suppository and pessaries. In an interaction with Usha Sharma, he reveals more about the new manufacturing facility in Indore, the companyâ&#x20AC;&#x2122;s future plans and key initiatives taken by the present government You plan to develop waxbased suppository and pessary products from the new manufacturing facility in Indore, Madhya Pradesh. Will it be for global as well as Indian markets? Suppository and pessary products will be majorly for global markets, as the requirement of these products in the Indian market is still limited and as per demand, we may introduce some products here. Why are Indian medical practitioners not encouraging suppository and pessary products in India? Suppository and pessary are administered through vaginal or rectal modes. There could be multiple reasons regarding these being unpopular. While being administered, these drugs come in contact with rectal mucosa which may cause irritation or slight damage. Other than this, patients may not be willing to the administration mode which may affect adherence to treatment. The mode of absorptions is not as convenient as other modes for Indian society, and hence it is less acceptable. Also, the gastrointestinal state affects absorption of the medicines. How to create awareness among doctor and patient communities on the advantages of these products? Awareness is low in India pertaining to suppository and pessaries amongst both doctor and patient communities,

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although the former has better understanding. Both need to be sensitised about the benefits which includes faster absorption, can be administered easily to paediatric and unconscious patients, does not cause vomiting or gastric issues, can be administered to patients with vomiting and to whom oral intake is restricted. In case of pessaries, high concentration can be delivered at the effected site without causing much systemic effect, because of which frequency and duration of dose can be decreased, eradication of disease and compliance increased. The first line is to convince doctors to start prescribing them and explain the patients the way to administer them. Once patients understand the product and its benefits, they will begin using it. Also, through various advisories, campaigns and advertisements, the benefits of these products can be popularised. At the same time, it is important to educate patients on the disadvantages such as rectal/vaginal irritation, so that they are cautioned but not alarmed. What role can pharma companies play in creating this awareness? Pharma companies can partner with healthcare facilities in promoting ways to deliver drugs and can have seminars in both rural and urban areas to promote the concept and the advantages of such delivery systems.

parts of world also. For the Indian markets, at present, we are in eight states and we aim to provide quality and quantity in all these states and then slowly cater to other markets as well.

Tell us about your marketing strategies. How are you expanding your horizons in the Indian market? Kusum Healthcare is growing geographically and also product wise. Currently the company has its presence in 10 countries and has manufacturing units in two countries. We have over 100 products and lot of new products in the pipeline for existing as well as upcoming

markets . We are increasing our presence in 11 countries in Africa and also in Latin America. Successfully completing all the audits of these countries, by end of November 2018, we will be starting our operations in Kenya. By 2020, we should be having registrations in six African countries and two to three in Latin America apart from CIS countries. Kusum visions to open plants in other

In 2009, the company started its pharmacovigilance cell. How did it help the company grow ? What steps are you taking to boost it further? The existence of pharmacovigilance cell confirms that the company has a mechanism to give continued support in not only analysing the side effects, but building and updating a mechanism to prevent incidents in the future. This cell also makes sure that quality issues and the lack of efficacy are tackled in a more scientific way. This cell also resolves many issues regarding the presence or absence of scientific data pertaining to indications of any products in different cases. The presence of such cell gives confidence to prescribers to use products of the company and get support in case their patients suffer from side effects.. For OTC products â&#x20AC;&#x201C; the presence of Pharmacovigilance cell confirms that the information shared in different forms of media are based on scientific knowledge and no false claims are advertised. The presence of the cell gives confidence to the consumers that there is a system in the company to whom they can approach in case some side effects occur to them and they believe that the company is confident in its quality â&#x20AC;&#x201C; which

MARKET makes them create this cell even when there was no regulatory requirement. Hence, the presence of this cell boosted the confidence in both the prescribers and the consumers – which helped the company grow at a rapid pace. Steps to boost confidence in prescribers and consumers will be to conduct scientific seminars for prescribers, creating scientific monographs for each product, patient education programmes in forms of medical camps, creating better delivery systems to overcome many side effects. Overall, what are your capex plans and investments for this year? We have chalked out our capex plans and below mentioned capex shall be funded out from internal accurals only. Bhiwadi – ` 600 lakhs Indore - ` 2800 lakhs HO – ` 260 lakhs Ukraine – ` 1000 lakhs Total – ` 4660 lakhs Tell us about the impact of GST on the pharma industry? The overall impact of GST on pharma industry has been majorly positive. Like any other industry, there were teething troubles when the policy was implemented. However, as and when the system got streamlined and with better understanding, things began to fall into place. Implementation of GST has improved transparency in manufacturing and distribution. It has created opportunities to make supply chain more efficient and have made the job work model or loan licensing model relatively simpler and clear. It has eliminated the cascading effect of multiple taxes on a single product. Kusum Healthcare is more than two decades old and has established a strong presence in the international markets. Give us an update on your international presence? The Kusum Group is one of the most recognised names in the pharma industry in the CIS economies of Ukraine, where it has been running a fully integrated R&D,

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manufacturing, quality testing and monitoring, marketing and distributing operation. They also have operations in Kazakhstan, Uzbekistan and Moldova, Malaysia and Cambodia in the ASEAN markets of Myanmar, Philippines and Vietnam, apart from India. We are presently looking towards developing and

growing economies, and plan to spread towards African countries in the near future. What are your plans for the developed markets? Our main focus remains towards developing economies where we hope to find more consumer base than developed countries and we are moving

forward in that direction. This year, the Make in India initiative will be celebrating its fourth anniversary. What are your views on the initiative and its impact? 'Make in India' is the way India needs to go and we are in agreement with the government's intention and

objectives on this front. Out of our four manufacturing units, three are in India, two in Bhiwadi (2007 and 2015), and the latest one in Indore (2018). Any policy of this nature needs a longer duration to show impactful results; the important thing is that we're looking at the right direction. u.sharma@expressindia.com

cover )

As India gears up to celebrate its 72nd Independence Day, we examine a few factors which will be crucial to liberating the true potential of our pharma industry By Lakshmipriya Nair

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August 1-15, 2018

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ndia is gearing up once again to celebrate its Independence Day. And we have a lot of things to rejoice about. Falsifying the predictions of disaster and doom when it became independent in 1947, India has grown from strength to strength to become the largest democracy and the sixth largest economy in the world. Once called a ‘country of illiterates’, today India’s literacy rate is 74 per cent. Food grain production has grown manifold from 50.8 million tonnes in the 1950s to 272 million tonnes in 2016-17. Our life expectancy has increased considerably from 32 years in 1947, to 68.35 years in the current times. Since liberalisation and subsequent reforms in the 1990s, we have witnessed very rapid fiscal growth and development. Let’s not forget that India is the first country to enter into the orbit around Mars on its first attempt. Thus, in the past 71 years as a sovereign nation, we have traversed a journey interspersed with several triumphs and achievements. Yet, it is also very evident that we are still battling multiple challenges on different fronts. We have covered many miles and kept many promises but we have many more miles to go and many more promises to keep. So, even as we laud our successes, it is important to introspect on our shortcomings and keep reinventing ourselves to emerge as a stronger nation. Hence, as a leading industry publication, Express Pharma, in its Independence Day Special issue, examines factors which will be game changers in future, as far as the pharma sector is concerned.

India Pharma Inc’s journey Our pharma sector too is one of our success stories and has been a huge contributor to India’s progress. Post-independence, the sector’s ability to provide quality, affordable and accessible medicines made it an important determinant of the country’s fiscal development as

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FIGURE 1: PROGRESS OF INDIA’S EXPORTS OF PHARMACEUTICALS DURING THE LAST THREE YEARS Category

2014-15

2015-16

2016-17

Change %

Bulk Drugs and Drug Intermediates

3565

3597

3401

-5.47

Drug Formulations and Biologicals

11214

12648

12701

0.42

AYUSH

118

111

124

11.65

Herbal Products

236

253

280

10.66

Surgicals

299

303

334

10.37

Total

15433

16912

16840

-0.43

Source: Pharmexcil Annual Report 2016-17

FIGURE 2

Source: ASSOCHAM report on Indian Pharma: Enabling the transition to innovation-led growth well. With rising exports of affordable medicines to various parts of the world from our country, it has earned global recognition as the ‘Pharmacy of the World’. On the other hand, challenges such as the entry of foreign players, compliance issues, low margin of profits due to pricing pressures, low input for R&D etc. are dogging the heels of this industry and hindering its advance. There is growing over-dependence on drug imports from China, we are faced with the challenge of making the transition from imitative to innovative and haven't mastered the art of utilising data effectively to leapfrog progress. However, the answers to

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these challenges lie within themselves. Therefore we have identified three ‘Is’ i.e. Indigenisation, Innovation and Information as factors which would play key roles in mitigating our challenges and accelerating our development. Let’s examine why they have emerged as such crucial elements of India Pharma Inc’s growth trajectory.

Indigenous success The sector already owes a lot of its success to indigenisation. Soon after independence, India adopted a robust economic policy guided by the philosophy of self-reliance and selfsufficiency. Strategic interventions through incentives for lo-

calised production and regulation of prices enabled our country to develop and manufacture cost-effective medicines for domestic use and global markets. Girish Arora, Founder & Managing Director, Alniche Lifesciences shares some vital statistics about the industry in the current day. He accentuates, “Today, India is the source of 60,000 generic brands across 60 therapeutic categories and manufactures more than 500 different active pharma ingredients (APIs). The export of generic drugs is one of India's core strengths. (Check figure 1) He further informs, “The country is home to 3,000 pharma companies with a strong network of over 10,500

manufacturing facilities. The cost of production in India is around one-third of that in the US and almost half of that in Europe. Indian pharma sector supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicine in the UK. Presently, over 80 per cent of the antiretroviral drugs used globally to combat AIDS are supplied by Indian pharma firms.” The leading trio from STEERLIFE, Dr Himadri Sen, Chairman, Steerlife; Indu Bhushan, CTO & Director, SteerLife India; and Dr Babu Padmanabhan, MD & Chief Knowledge Officer; also point out, “The Indian pharma industry has made significant multidimensional progress encompassing all essential components, processes and systems associated with development to commercialisation of drug products globally. There has been a constant spirit of innovation in reducing costs and providing affordable medical care to patients not only in emergingeconomies but also in developed economies.” However, in a bid to provide very affordable medicines, over a period we have developed a very disproportionate dependence on China for active pharma ingredients (APIs) and bulk drugs. Our neighbouring nation accounted for 66 per cent of India's total bulk drug imports in 2016-17 at `12,254.97 crores. This, in turn, has emerged as a mammoth threat to our progress. Be it about the quantity of supply and price or quality of finished products, this situation has allowed a lot of power to be vested with China, as far as our pharma sector is concerned. Given our geo-political situation, we need to be very careful about this fact. Hence, there is an urgent need to encourage domestic production of raw materials required for the life sciences industry. The move is also vital to retain India’s position as a leading generic drugs supplier in the global markets. At the same time, as we strive to move up the R&D value

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August 1-15, 2018

cover ) chain, the government’s policies and measures should encourage and ensure easy and affordable access to quality raw materials and equipment. It would also comprise enabling a more conducive environment for innovation and helping maintain our cost-competitiveness in the global market. Fortunately, taking cognisance of these factors, the government is implementing various measures to reduce imports. For instance, since 2016, the government had withdrawn exemption in customs duties to certain categories of bulk drugs. Similarly, a scheme under which common facilities in bulk drug parks will be financed by the government to develop the pharma sector by reducing cost of drug production has been approved. Measures like easier environment clearance are being enforced to boost domestic manufacturing of bulk drugs. Both, state and central governments are trying to boost manufacturing of pharma equipment as part of the ‘Make in India’ strategy as well.

NCES AND NBES: MORE THAN 30 MOLECULES IN PIPELINE

Source: Assocham report on Indian Pharma: Enabling the transition to innovation-led growth

So, the industry would have to adopt innovation in a big way, be it in plant design, drug discovery or drug delivery systems. However, as Dr Sen, Bhushan and Dr Padmanabhan point out, “To build the ecosystem for new drug discovery and research may remain an endeavour with high level of unpredictability, cost and time.” Hence, India Pharma Inc would also need to galvanise its efforts and policies on innovation into a more coherent, national level strategy. The situation demands significant investments and resource commitments to build the right innovation infrastructure as

INVESTMENT TRENDS OF LIFE SCIENCES COMPANIES IN DIGITAL TECHNOLOGIES

Fostering innovation The clear correlation between innovation and growth has dawned on the Indian pharma industry. Rishad Dadachanji, Director, Schott Kaisha, echoes the industry’s views when he says, “Innovation-led development should be a key strategy for all player in any industry today. Progress and prosperity is led by innovation and this ensures a strong and secure position for any industry in the global market.” Drawing the bigger picture, Pushpa Vijayraghavan, Director, Sathguru Management Consultants also underscores, “It is time we see healthcare access beyond affordability – it is not sufficient to ensure low drug prices, it is also important that we can indigenously provide our population access to contemporary and emerging therapies.” These considerations have also brought in a realisation that while our strategy of

20 EXPRESS PHARMA August 1-15, 2018

Leveraging information

Source: Infosys study on Digital Outlook: Life Sciences Industry developing and marketing copies of patented chemical and biological drugs at discounted prices might have brought us this far, it wouldn’t suffice if we

are seeking a leadership position in the global pharma industry. Its further advance will depend on the ability to generate new ideas, processes and solutions.

sector. To its credit, recognising the necessity to rework its storyline, Indian Pharma Inc is making a shift from an importer of imitative drugs to an innovator. But, it wouldn’t be possible without support from the government; ramping up of R&D capabilities, and a very effective intellectual property protection (IPR) framework to facilitate indigenous process development. Thankfully, there have been some measures in this direction. As Dr Ashwini Kumar, CEO CliniExperts informs, “India is creating and evolving a system for supporting and funding science, technology and innovation (STI). Various government ministries, departments and agencies in public domain, universities and several entities in private domain constitute the ecosystem of STI support and funding in India e.g. BIRAC, Make in India, DRDO etc.” Similarly, a report released by Assocham in May 2018 highlights that Technology Development Board (TDB) under DST has been providing financial assistance up to 50 per cent of project cost in the form of soft loans. Birac’s i3 is a $ 250 million corpus with$ 125 million from the World Bank and an equal contribution from Government of India. It was created as part of Biopharma Mission to fund biotech start-ups and accelerate innovation in the areas of vaccines, bio-therapeutics and medical devices. The initiative funds companies to advance their assets and other capacity building efforts. Thus, we are on the path to progress in this arena and if we play our cards right, India can slowly turn into a centre of excellence for the pharma sector and spur the country's socio-economic growth.

well. The pharma industry will also have to create a large work force which would be capable of nurturing and spearheading a culture of innovation in the

Imperatives like improving manufacturing efficiency, resolving supply chain complexities, fulfilling changing consumer demands, ensuring compliance with global regulations and

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THE MAIN FOCUS

GROUP

Innovation is life

Nutraceutical products are

(ePRO), and behavioural and sensor data along with various algorithms. ◗ Using analytics and pattern recognition to support clinical trial participants by detecting disease early and driving valuebased care. ◗ Improving business process efficiencies of pharma companies by investing in risk based monitoring to predict key events, collaborative automated authoring, automated publishing of clinical trial outcomes to regulators, track and trace systems throughout the distribution process, e-labels, and IoT-led predictive maintenance in pharma factories. ◗ Using technology to achieve greater patient-centricity during clinical trials. This includes a number of measures such as employing wearable devices to remotely track clinical trial patients and digitally integrating electronic medical records to have a single source of truth for health data. ◗ Using mobile technology to educate patients about drug safety and effectiveness, gather data, or send reminders about medication. Therefore, information and its exchange, aided by digitalisation, would be a major game changer in the life sciences industry.

highly sensitive to

moisture

Three ‘I’s and their impact India had envisioned as a newly liberated nation in 1947. Lines from our first Prime Minister’s famous speech, ‘Tryst with destiny’ clearly outline this vision. The words were: “The future beckons to us. Whither do we go and what shall be our endeavour? To bring freedom and opportunity to the common man, to the peasants and workers of India; to fight and end poverty and ignorance and disease; to build up a prosperous, democratic and progressive nation, and to create social, economic and political institutions which will ensure justice and fullness of life to every man and woman.” Hopefully, the three ‘I’s would also be instrumental in enabling the pharma sector to play a key role in achieving this dream. On a more immediate note, r that the industry will need to leverage these three ‘I’s to resolve its greatest business challenges and move towards the next level of growth. Express Pharma also spoke to a few industry professionals on these three aspects to gain insights from their experience. Check out their views and strategies in the subsequent pages. lakshmipriya.nair@expressindia.com

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building credible reputations etc. have made it utterly essential to build and analyse data effectively. Reportedly, pharma companies are utilising the digital technologies like cloud, mobility, and social media to manage in-house costs, enable amalgamation of information and processes across departments and improved profiling of clients. Thus, it is no wonder that a study by Infosys, titled, ‘Digital Outlook: Life Sciences Industry’ reveals that Big Data analytics, followed by cyber security and AI, are the most common digital technologies being utilised by life sciences companies today. It emphasises, “Organisations are mainly placing their bets on technologies that could help them improve existing operations rather than emerging or disruptive technologies. These trends were improving cyber security to protect patient and clinical trial data, using the cloud to improve data and data analytics, and collaborating within the industry to share information and thereby improve patient outcomes.” The report also lists down the ways in which data or information is augmenting the progress of life sciences companies and the digital technologies aiding the able use of information: ◗ Automating pre-work in clinical research by using optical character recognition (OCR), search engines, and AI, complete with a chatbot user interface, for knowledge management ◗ Improving safety of drugs by improving data ingestion, data quality, and including data mined from practitioners’ mining literature and social media to augment structured data. Currently there exists a number of challenges – process gaps, lack of visibility, etc. – which the life sciences industry can fix by digitising the flow of intake. Companies can use a benefit risk assessment tool, which uses algorithms. They can also use visualisation and reporting tools to analyse structured and unstructured data and compare the risk benefit profile of a drug with competitive offerings using metrics like AngioedemaQuality of Life (AE-QoL) and adherence, and make informed decisions on how to take the drug forward. ◗ Investments in new patient-centric platforms to support clinical trials throughout the life cycle, from patient identification, screening, and recruitment, to eConsent, adherence, and engagement. To facilitate the last two, the platforms leverage clinical, claims, electronic medical records (EMR), electronic patient-reported outcome

cover )

Revolutionising India Pharma Inc with indigenisation,innovation and information

With a strong R&D base and academic talent, India has the potential to become a leading innovation player in biotechnology and pharma

Indigenisation in Indian pharma industry will boost the economy and generate huge numbers of employment in the country as well

DR ASHWINI KUMAR CEO, CliniExperts

GIRISH ARORA Founder & Managing Director,Alniche Lifesciences

nnovation generally refers to changing processes or creating more effective processes, products and ideas. Innovation is pragmatic in discovering drugs, developing therapeutics and delivering healthcare as per Indian needs. It is only by creating innovation in technology, strategies, practices and policies that Industry can take on global healthcare challenges. The decade 2010-20 has been declared in India as the Decade of Innovation. We have formulated a science, technology and innovation policy, aimed at an innovation-led development. This policy calls for creating an ecosystem for innovation activity to thrive in our country. It highlights the need to encourage and recognise grass roots innovators. With a strong R&D base and academic talent, India has the potential to become a leading innovation player in biotechnology and pharma. India's contribution to affordable healthcare goes much beyond being a pharmacy of the world. GE's Research Centre in India has developed a number

22 EXPRESS PHARMA August 1-15, 2018

of low-cost bio-medical equipment from scanners to portable electrocardiograms as has Bristol-Myers Squibb developed a number of promising novel drugs at its partnered research centre in Bangalore. Biocon, on the other hand, has not only developed insulins in India indigenously through a proprietary technology in the early 2000s, but has also developed and delivered two affordable novel biologics for the benefit of cancer and psoriasis patients in India. India is therefore proving its mettle as a â&#x20AC;&#x153;laboratory for the worldâ&#x20AC;? that can deliver affordable innovation and a growing number of collaborative efforts are succeeding in delivering products and services that can go a long way in ensuring that the right to healthcare becomes truly universal. India is a large diversified territory driven by volume consumption as compares to value, and is dependent on in-licensing the technologies. Fostering innovation can also support Make in India initiative, augment employment, support the Start-up India mission etc.

ndigenisation in the Indian pharma industry is very much supported by the available resources in India i.e. large educated population, scientistsâ&#x20AC;&#x2122; pool, technologies and initiatives taken by the government to drive the concept. For instance, 100 per cent Foreign Direct Investment (FDI) is allowed under the automatic route for greenfield pharma and 74 per cent FDI through brownfield pharma under the automatic route. Under the Pharmaceutical Promotion Development Scheme (PPDS), the government extends financial support to conduct seminars, conferences, exhibitions, and mounting delegations to and from India for promotion of exports as well as investments, conducting studies for facilitating growth, exports as well as to discuss on critical issues affecting pharma sector. Other measures to support indigenisation of the sector include training/knowledge improvement activities on issues relevant to growth

of pharma industry; pharma technology upgradation; strengthening of existing infrastructure facilities to make Indian pharma industry a global leader in pharma exports; enhancing the quality, productivity and innovative capabilities of the SME pharma sector in the country; helping industry meet the requirements of standards of environment at a reduced cost through innovative methods of common waste management system etc. Financial incentives such as market exclusivity, reduced R&D cost including tax credit on R&D cost; R&D grant for Phase I to Phase III clinical trials and the User or Registration Fee Waiver Act for biologicals and orphan drug cases to promote their maximum use in India would also prove to be very beneficial. Indigenisation in Indian pharma industry will boost the economy and generate huge numbers of employment in the country as well.

( INDU BHUSHAN CTO & Director, STEERLife India

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DR BABU PADMANABHAN MD & Chief Knowledge Officer, STEERLife India

DR HIMADRI SEN Chairman, STEERLife India

Considering the success Indian industry has shown to create copy-cat drug products, the ecosystem is ripe to create hybrid NDAs, which have been sporadic and serendipitous in nature

eople with knowledge combined with the availability of tools, technologies and ingredients are essential part of the innovation ecosystem to foster new drug development leading to improved convenience, compliance, efficacy and safety. Interestingly, there exists great possibility to innovate and address unmet medical needs by unique solutions built on smart strategy of relying on information available from previously approved drugs, essentially with novel approaches leading to improvement in delivery and clinical use. Several regulatory agencies, recognising pressing needs and immense benefits of innovation in healthcare, have made available, well-defined pathways of review, approval and market exclusivity of these hybrid new drug ap-

plications. In 2012, Generating Antibiotic Incentives Now (GAIN) was passed as part of US Food and Drug Administration Safety and Innovation act (FDASIA) to address public health threat of antibacterial drug resistance by stimulating the development and approval of new antibacterial and antifungal drugs. The US Food and Drug Administration (FDA) has already approved 12 drug products with Qualified Infectious Disease Product (QIDP) designation, each receiving a priority review apart from granting 147 QIDP designations, including approximately 74 designations for novel drugs in a short span of approximately five years. It is important to note that in 2017, more than 50 per cent of all NDAs approved have been 505(b)(2) drugs.

This percentage is expected to rise to more than 80% over the next few years due to obvious low risk, relatively small program budget, accelerated development and approval and extended market exclusivity. A few examples of such success stories are briefed below: ◗ PROCARDIA XL is a zero-order release tablet of Nifedipine that not only reduces dosing frequency from thrice a day to once a day but also significantly improves the efficacy to safety ratio. ◗ Cipro XR not only resulted in reduction of dosing from 2/3 times a day to once a day thus improving patient compliance but also extended the usage of the molecule for resistant UTI which otherwise could not be treated with the immediate release tablets. ◗ ABSORICA, a semisolid filled hard

At least on critical APIs which are required for essential medicines, India needs to be self-reliant. Indian pharma majors need to look at backward integration at least for their flagship brands and develop a long term business continuity plan DR AJIT DANGI President & CEO, Danssen Consulting

lthough we have achieved the distinction of being the ‘Pharmacy of the World’, our over dependence on APIs imported from China is a major geopolitical risk.

Independence with APIs Blood pressure drug Valsartan, manufactured in China by Zhejiang Huahi Co., contaminated by an impurity NDMA (Nitrosodimethylamine) which has a potential carcinogenic risk and banned in 22 countries including India, is another ex-

ample of the risk involved in such dependence. Recently, after closing down over 145 API manufacturing facilities in China for non-compliance of environmental laws, there has been shortages of many products in India such as Vitamin C based formulations. At least on critical APIs which are required for essential medicines, India needs to be self-reliant. Indian pharma majors need to look at backward integration at least for their flagship brands and develop a long term business continuity plan. The trade war

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between China and the US, Brexit in UK are some of the indications of shape of things to come where India can suffer a collateral damage. As in the words of Ruchir Sharma, Chief Global Strategist of Morgan Stanley, one of the major trends in 2018 onwards is ‘Deglobalisation’, India needs to be prepared for this mega trend.

From imitation to innovation While India is proud of being the third largest manufacturer of pharma products

gelatin capsule formulation of isotretinoin has improved efficacy and patient compliance over soft gelatin capsule formulation of this drug. Considering the success Indian industry has shown to create copy-cat drug products, the ecosystem is ripe to create hybrid NDAs, which have been sporadic and serendipitous in nature. The time of entry of the innovative new product is very critical to ensure market success. Preferably, such products, need to be introduced well before generic competition to create maximum value. To start off with, a focused and concerted effort by a few players to achieve repeated success would act as an impetus for many more players to join in the path of innovation, growth and sustainable business.

in terms of volume in the world, we need to transit from imitation to innovation. The strategy of reverse engineering has paid us rich dividends, time has now come to move up the value chain from cost arbitrage to intellectual arbitrage by using innovation as a platform. For this, we need to foster an ecosystem of strong Intellectual Property protection, human capital of talent with requisite skill set and policy initiatives to incentivise innovation. Another important issue is of economies of scale and scope and optimum utilisation of capacity. According to IMS report, 95 per cent of our domestic sales revenue of about `1.2 lakh crores comes from top 150 companies. We have today over 9000 manufacturing pharma companies. Time has now come for consolidation which is also required from the point of view of meeting global quality compliance standards as the manufacturing infrastructure required for this is increasingly becoming sophisticated and expensive.

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August 1-15, 2018

cover ) Government of India is promoting indigenisation of goods and services through 'Made in Indiaâ&#x20AC;&#x2122; campaign. This can be used as a key strategy to help indigenisation of the Indian pharma industry as well

The industry is not devoid of attempts to engage in NCE development. However, success is glaringly elusive. This calls for deeper introspection and policy measures

RISHAD DADACHANJI Director, SCHOTT KAISHA

PUSHPA VIJAYRAGHAVAN Director, Sathguru Management Consultants

Promoting indigenisation As we have seen, the government of India is promoting the indigenisation of goods and services available in the country through the 'Made in India campaign.' This can be used as a key strategy and advantage to help the indigenisation of the Indian pharma industry as well. Today, the pharma industry in India is rapidly growing and so is its dependence on APIs from foreign countries. Even if we look at other industries such as the defence industry, India is the worldâ&#x20AC;&#x2122;s largest importer of defence equipment and is dependent on other countries to fulfil its requirement. Hence, the government has decided to try and boost jobs and FDIs in India through the indigenisation of the defence industry. The Indian pharma industry too can adopt similar strategies either through tech transfers or through the development of high quality sources for key APIs in India itself.

Building an innovative ecosystem Innovation should not only be looked at from a point of developing new products, but should be used for the improvement or evolution of existing products as well. Temperature sensitive products can be made to resist

24 EXPRESS PHARMA August 1-15, 2018

higher temperatures which leads to better stability in poor or uncontrolled conditions such as transportation. Painful injections can be made to be painless and aseptically filled products can be made to withstand terminal sterilisation to ensure sterility of the product. Such innovation can be advantageous to several existing products, as this finally impacts the end consumers by promoting patient safety. It also creates confidence with doctors which finally results in the product gaining a key position in the market by becoming the preferred choice.

Healthy exchange of information In India, we have a large number of pharma companies working on several products for many years. Each company has generated large amounts of data, based on their scale, relating to their product portfolio. If this data is shared between these companies, each of which have their own area of expertise, there could be several advantages. This healthy exchange of information could strengthen the position of these companies in the Indian market itself, further promoting the indigenisation of the Indian pharma industry.

wenty years after the product patent regime commenced, we still cannot boast of a robust drug discovery engine or a notable level of novel drug pipeline in the country. We have nurtured a solid foundation of generics with revenues north of $35 billion and substantial export success. Investment capability is then not the constraint in an industry with an aggregate balance sheet of substantial size. The industry is also not devoid of attempts to engage in NCE research or development. However, success is glaringly elusive. This calls for deeper introspection and policy measures that can trigger sustainable innovation engagement. Foremost, it is critical to appreciate the risk level and gestation period in discovery and development and resultant reticence in industry investments. While industry is not averse to the idea of investing in higher risk R&D, the level of binary risk has always been an impediment to investments stepping up to an optimal level. With sub-optimal level of investments, the cycle of investment and value realisation is never set in motion. Only when initial investments lead to fruition on commercialisation and monetisation milestones, are additional investments likely to follow.

Here is where extra-mural government funding could play a catalytic role. Government grant funding accessible to ventures has substantially gone up in the last decade and has in fact been a major driver for the current entrepreneurial wave. However, the extra-mural funding allocation of about $150 million has been insufficient for drug discovery ventures given the scattered support to more than 400 ventures and relatively sub-optimal level of programmatic investment per venture. To nurture an indigenous drug discovery engine, we need to redesign our funding programmes for novel drug development and ensure tenor and quantum of foundational support stretches through a while cycle for the initial pipeline. It is also critical to take cognisance of weak pipeline of globally benchmarkable translational solutions in domestic institutions. Combining pragmatism and considerations for sustainability, we should ensure funding for technology access from global sources while simultaneously channelling intra-mural funding in a manner that our institutional backbone can rev up the engine in the decades to come. The India discovered drug shouldnâ&#x20AC;&#x2122;t be a one-off wonder, we have to make it the order of the day in the future.

MANAGEMENT

Fix DAVAportal,says industry to DGFT Faced with delays at ports and possible product recalls, industry hopes the DGFT will fix the issues with the DAVA portal as well as issue clarifications.But with just three months to go to the mid November deadline, time is running out fast. By Viveka Roychowdhury

ndia's serialisation and traceability journey has been a series of extensions and delays. This defines the Government of India’s dilemma of dealing with a very diverse sector, comprising companies of all sizes. The latest extension came this May. The Directorate General of Foreign Trade (DGFT) public notice dated May 9 specifies that export of drugs manufactured by SSI and non-SSI units, manufactured on or before November 15, 2018, are exempted from maintaining data in the parent-child relationship for three levels of packaging and uploading this data on the central DAVA portal. All drugs manufactured after this date can be exported only if both tertiary and secondary packaging carry barcoding as applicable and the relevant data is uploaded in the DAVA portal. For more than two years, pharma companies have expressed significant concerns regarding the DAVA database, including in a detailed white paper published in May 2017 by RxGPS, an alliance of pharma stakeholders. (See story: http://www.expressbpd.com/pha rma/pharma-technology-review/making-sense-of-serialisation/389701/) Will the two sides, DGFT and pharma companies, use this extension of six months address these issues? As is to be expected, companies have their expectations and wish list. For example, Aditi Kare Panandikar, Managing Director, Indoco Remedies says, “It is essential that the DGFT audit and certify the line level and software level vendors for compliance. This will be a major help to pharma companies in vendor

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August 1-15, 2018

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MANAGEMENT selection. The DGFT authorities should also finalise the minimum set of machinery for compliance and also publish the same, so that small/midsized pharma companies know where to invest, as vendors confuse them with requirements.” Shivaji Chakraborty, Asst General Manager, Packaging Development, Fresenius Kabi Oncology suggests three steps to be taken during this period of delay for DGFT to address the technical problems. The first step would be to organise meetings with industry to understand the difficulties faced by the companies and take actions accordingly. The next step should be to evaluate the requirement and come up with a proposal in line with global requirements. For example, in the case of tertiary level packaging, the US requirement is to print the serial shipping container code (SSCC) number (an 18-digit number used to identify logistics units) on the logistic pack, irrespective of homogeneous and heterogeneous pack while India's requirement is for the SSCC number, along with the GTIN and other batch detail. The third step he suggests is that DGFT sets up a technical support team. Equipment manufacturers like Gaurav Mohite, Product Manager, Global Track & Trace Portfolio, ACG are hoping that pharma companies will use the extension to “gear up and set-up the process to enforce critical aspects of serialisation within their organisation. As per the market feedback, most customers have been struggling in implementing complete control over the process, so as to ensure that the correct data gets uploaded to DAVA portal.”

Data security a must ... Kare Panandikar echoes most of her peers when she says that while the pharma industry has welcomed the DAVA system, there are still a few concerns like the non-availability of a good knowledgeable vendor for serialisation, the very high cost of equipment procurement and the non availability of trained re-

26 EXPRESS PHARMA August 1-15, 2018

Urgent export consignments were kept on hold for more than 15 days at the ports. This led to decrease in the company’s export revenues and also shortage of the products at the customer’s end Aditi Kare Panandikar Managing Director, Indoco Remedies

Complete track and trace implementation is an extremely critical project and the Indian government has been able to successfully implement the serialisation and aggregation requirements with data reporting aspects in a phase-wise manner. Today, we can see many countries following a similar trend to implement track and trace capabilities in a phased manner Gaurav Mohite Product Manager, Global Track & Trace Portfolio, ACG

Dummy serial numbers is a data integrity issue. Serial numbers available in the database but physically not present may lead to confusion. And secondly, at present it may not be misused, but once authentication is implemented, the dummy serial numbers can be misused by the counterfeiter Shivaji Chakraborty Asst General Manager, Packaging Development, Fresenius Kabi Oncology

sources for serialisation qualification and implementation. She also points out that many vendors claim to be compliant, however, there are very few who are actually capable of complying with the regulations. Data that need to be uploaded to the portal, include details of the product, distribution point, batch, production, movement and aggregation but Chakraborty points out that there is lack of clarity about distribution point and movement details. (See box: Challenges faced on DAVA portal and some suggested solutions) Overriding all of these con-

cerns, is the possibility that this data could be visible to other companies and the lack of technical support to address these issues. ACG's Mohite too echoes this point, saying, “Considering the increase in cyber threats globally on databases and the potential manipulation of the market perceptions by some organisations using this data, the data security and integrity becomes one of the key concerns for any organisation.”

..but what about “dummy data”? DGFT's requirement that manufacturers upload

“dummy” or fake serial numbers for primary packages (i.e. individual vials, blister cards, or bottles) that are not serialised is possibly the most confusing requirement. Since the DAVA system requires the upload of serial numbers for these primary packages, DGFT advised manufacturers to upload “dummy” or fake serial numbers for primary packages that are not serialised. As a result, millions of fake serial numbers are being added to the DAVA database. There are concerns that these fake serial numbers could be applied to counterfeit drugs destined for countries all over

the world. “Dummy upload will not serve the purpose of traceability. This will increase cost to the company, as these numbers, if saved on the external server, will be charged,” points out Kare Panandikar. This use of serial number identifiers along with the requirement that serial number identifiers be unique at the company and not the product level will result in large manufacturers depleting serial number data pools as well, point out some industry sources. Chakraborty minces no words when he says, “Dummy serial numbers is a data integrity issue. Serial numbers available in the database but physically not present may lead to confusion. And secondly, at present it may not be misused, but once authentication is implemented, the dummy serial numbers can be misused by the counterfeiter.” On the other hand, some observers see this issue as a step in the journey and do not seem too perturbed. “We believe uploading “dummy” or fake serial numbers for primary packages that are not serialised is just a step towards making DAVA portal equipped for future primary packaging implementation. In our opinion, when DGFT enforces primary serialisation, the data handling and management requirements for DAVA are going to increase drastically.” Industry sources list more technical challenges that made it difficult to use the DAVA system and export to waiting countries. For example, DGFT requires the use of a product numbering scheme that is inconsistent with global data standards. As a result, manufacturers are forced to choose between changing their entire numbering scheme—a cost that cannot be justified—and applying multiple product numbers to packages. The latter has caused significant operational challenges in countries of import and slowed or stopped the distribution of pharmaceuticals made in India. Further, manufacturers

MANAGEMENT seeking exemptions from the export requirements for product destined to countries with existing traceability requirements (permitted under the law) are forced to apply for exemptions product by product. This not only slows the process, but can create confusion if product exemptions have not yet been approved— leading to a situation where a product must comply with two different sets of serialisation and traceability requirements. The suggestion is to exempt all products exported to markets with existing regulations, which can alleviate this burden and confusion.

Safety and security There have been questions on the safety of the DAVA database in terms of controlling access to the system and data to legitimate users and pro-

tecting data from competitors. There are concerns that data uploaded to the DAVA system is also unsecured: manufacturers (or any other entity with access to the system) are currently able to see product and batch information from other contributors, including competitors, which could be used for anti competitive purposes—or to make counterfeit product look legitimate, and either outcome could position India as an undesirable place to do business. Users seem divided on this front. Chakraborty of Fresenius Kabi Oncology doubts that the DAVA database is secure as anyone having the digital signature to log-in to DAVA portal can access the data of the competitors. “Although we have not yet faced any problem, but this easily available data can be misused

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Customers faced with such disruptions in supply could choose to switch to suppliers from other countries

by the counterfeiter.” Kare Panandikar of Indoco Remedies on the other hand opines that it is secure as one has to digitally sign to login to the portal. In Mohite's assessment too, the dummy data currently uploaded on the DAVA portal cannot be used for authentication purpose, which means that at this point the misuse of the dummy data cannot arise. But Kare Panandikar acknowledges that her company has faced a significant downtime of the DAVA systems. “Most of the time the website could not be accessed while uploading data.” Mohite also recalls that initially when most customers started using DAVA portal, they faced some problems regarding access and user control. “We learnt that the DAVA team had also gone through

the learning curve and were able to consolidate the portal to serve the DGFT requirements and manufacturer expectations.”

A dip in exports But the situation has already negatively impacted pharma exports from India. At Indoco Remedies, Kare Panandikar says,“Urgent export consignments were kept on hold for more than 15 days at the ports. This led to decrease in the company’s export revenues and also shortage of the products at the customer’s end.” Customers faced with such disruptions in supply could choose to switch to suppliers from other countries. Regulators in other countries too could choose to play safe, and subject consignments from India to great scrutiny, due to

EXPRESS PHARMA

August 1-15, 2018

MANAGEMENT

CHALLENGES FACED ON DAVA PORTAL AND SOME SUGGESTED SOLUTIONS CHALLENGES

SUGGESTED SOLUTIONS

Common portal interface for exports and domestic products: Although the requirements for products for the domestic market are yet to be defined, it is expected that those requirements will differ in at least some respects from the requirement for exported products given the differing goals and objectives of the two systems

The portal should include different upload interfaces for exports and products meant for the domestic market

Dummy serial numbers for primary package: Most global serialisation solution providers and their technology do not support generating dummy numbers and reflect this in the report file. Developing such technology involves cost, time and energy

Generation and use of fake data entirely contradicts good regulatory and business processes. Threfore the exporter should be allowed to leave the field blank

Uploading of price of product: The price column has to be filled by the exporter even though it is not a part of master data for export products.

The exporter should be allowed to leave the field blank instead of filling the column with fake data

Uploading of product image: High-resolution photos require significant data capacity, which exceeds the capacity of the DAVA portal. Exporters are facing difficulties to upload the data. Compressing photos to the size currently required makes the photos virtually unusable

DAVA portal should not require images of products to be exported

Single manufacturers cannot repeat serial numbers for different GTINs: The global GS1 standard permits a manufacturer to repeat a serial number for separate GTINs because even in those instances, the combination of the GTIN and serial number is unique. Manufacturers’data systems are configured consistent with the global standard, and revisions to ensure unique GTINs across all of a manufacturer’s products would be a significant and costly burden with no visible benefit.Also, the DGFT regulations and implementation guideline does not indicate that serial numbers must be unique across all GTINs.

Permit manufacturer to repeat a serial number for separate GTINs

Manual upload: The process of manually uploading data files to the DAVA database takes unnecessary time and burden to the system

DAVA should improve the upload process and make it automatic for improved productivity

Source: Shivaji Chakraborty, Asst General Manager, Packaging Development, Fresenius Kabi Oncology

data security concerns. Rebuilding trust with clients and regulators will take time and will impact revenues for quite a few quarters or even years.

Differing definitions leading to product recalls The complexity of serialisation is that each country follows different definitions. For example, the Indian regulations for exports define three packaging levels for serialisation: primary package (the serialisation of which is optional), secondary package and tertiary package. Chakraborty says that in many other countries, the requirements are based on the discrete packaging levels driven by trade. In the US, the saleable unit may be a primary package or a secondary package. In the European Union, the saleable unit is always the secondary package. As a result, a single packaging level is often understood and regulated differently in different countries. The confusion related to

28 EXPRESS PHARMA August 1-15, 2018

In the US, the saleable unit may be a primary package or a secondary package. In the European Union, the saleable unit is always the secondary package. As a result, a single packaging level is often understood and regulated differently in different countries packaging level terminology is especially challenging for products exported from India to a country that has its own serialisation requirements. Although India’s exemption for exports to such a country provides some relief, Chakraborty points out that confusion remains with regard to India’s requirements for tertiary packaging, which is not covered under such exemption. GS1 defines a tertiary package as the logistical unit that is shipped, the shipper, carton, case or a pallet that contains one or more pri-

mary/secondary levels of packaging. This means different or multiple levels of packaging can be “tertiary” packaging. This has created significant confusion, and as a result, he says labeling for product leaving India as “tertiary” packaging varies widely. In some instances, product exported from India to the US has carried two different GTINs. In other instances, the same GTIN (which is intended to be specific to a single packaging level) is affixed to multiple packaging levels. These types of discrepancies can actually stop the movement of

the product and, also can lead to recall, cautions Chakraborty.

Gearing up for the next phase Inspite of the several challenges, serialisation and traceability is no longer a choice but a necessity driven by regulation. As Mohite points out , “We know that 70 per cent countries had either finalised or are at the draft stage regarding their track and trace regulation for pharma industry. This situation in the global pharma market demands that Indian pharma

manufacturers must take the implementation seriously and upload the data in DAVA portal.” India is not the only country struggling with serialisation, which is possibly the most complex milestone to be navigated by the pharma sector across the world. It is now evident that such a project needs small, well planned steps rather than a leap into the unknown. As Mohite points out, “Complete track and trace implementation is an extremely critical project and the Indian government has been able to successfully implement the serialisation and aggregation requirements with data reporting aspects in a phasewise manner. Today, we can see many countries following a similar trend to implement track and trace capabilities in a phased manner.” The next phase of India’s serialisation and traceability journey starts on November 15. The question is, will we be ready? viveka.r@expressindia.com

MANAGEMENT REPORT

Opportunity for biotech firms to pursue drug candidates targeting metabolic disorders The GlobalData report found that big pharma companies lag behind small bio-techs in R&D efforts GENE THERAPIES have been a point of discussion during the last several years as a potential curative option for a variety of disease indications. The majority of the cardiovascular and metabolic disorder (CVMD) gene therapies in development are targeting cardiovascular indications, indicating immense opportunity for biotech companies to pursue drug candidates that target metabolic disorders, says leading data and analytics company GlobalData. The company’s report, ‘Gene

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Therapy in CVMD’ focused on CVMD gene therapies, which included candidates targeting coronary artery disease, critical limb ischemia, diabetic foot ulcers and Pompe Disease, and that are in development in the eight major markets (8MM; the US, France, Germany, Italy, Spain, the UK, Japan and urban China). The report found that big pharma companies lag behind small bio-techs in R&D efforts.<In addition, the report reveals that, despite investment in CVMD gene therapies, the majority of the candidates across

the 8MM are still in early R&D stages, whereas only a handful of CVMD gene therapies are in Phase II or Phase III clinical trials. Within the entire CVMD space, the current gene therapy pipeline features approximately 13 candidates that are in Phase I, II or III of clinical development. Only three gene therapies have reached Phase III trials: AnGes MG’s Collategene, Angionetics’ Generx and ViroMed’s donaperminogene seltoplasmid. EP News Bureau

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August 1-15, 2018

RESEARCH UPDATES

Eisai-Biogen to advance Alzheimer’s drug,provide fresh hope The news marked a rare success for Alzheimer’s research following failure after failure of candidates from companies including Pfizer, Eli Lilly and Merck & Co

isai Co and Biogen will move forward with latestage clinical trials of their Alzheimer’s disease drug, BAN2401, and are working with regulators to design the next studies and gain expedited review as a breakthrough therapy. The companies announced this month that despite failing at an earlier stage, the drug slowed Alzheimer’s progression at its highest dose, providing renewed hope in a field littered with failures. Japanese drugmaker Eisai said the treatment also worked

at lower doses. Full results will be presented at the Alzheimer’s Association International Conference in Chicago. The companies said after 18 months of treatment, patients who received the highest dose of BAN2401 saw a statistically significant improvement in cognitive and biological measures of Alzheimer’s versus placebo. That was a welcome surprise as the drug did not appear to be working at the 12-month mark. The news marked a rare success for Alzheimer’s research following failure after failure of

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candidates from companies including Pfizer, Eli Lilly and Merck & Co. It also raised hope for aducanumab, another Biogen/Eisai drug in final stage testing. Both treatments are antibodies aimed at removing toxic clumps of amyloid from the brain. Any successful Alzheimer’s treatment is virtually guaranteed to become a multibilliondollar seller. Alzheimer’s, the most common form of dementia, affects nearly 50 million people worldwide and is expected to rise to more than 131 million by

2050, according to Alzheimer’s Disease International. One difference, experts say, is that the Eisai/Biogen drugs are among the first to use PET scans to ensure study participants all have amyloid in their brains. Many dementia patients in previous trials later proved not to have the amyloid plaques the experimental drugs targeted, greatly increasing the likelihood of failure. The US Food and Drug Administration has said it is open to trials that measure effects on biomarkers, such as beta amy-

loid, rather than symptoms like memory loss, to allow companies to test treatments much earlier in the disease. The trial of 856 patients with early Alzheimer’s tested BAN2401 at five doses against placebo. Participants were evaluated using an Eisai-devised tool that drew from three established Alzheimer’s assessment scales. Kramer said the custom endpoint was important as prior cognitive scales were developed for people with later-stage disease. Reuters

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August 1-15, 2018

RESEARCH

US FDAapproves Krintafel for radical cure of P.vivax malaria First single-dose medicine to prevent the relapse of P. vivax malaria marks a major contribution towards malaria eradication efforts GSK AND Medicines for Malaria Venture (MMV) announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivaxinfection. Dr Hal Barron, Chief Scientific Officer and President of Research and Development, GSK, said, “Today’s approval of Krintafel, the first new treatment for Plasmodium vivax malaria in over 60 years, is a significant milestone for peo-

ple living with this type of relapsing malaria. Together with our partner, Medicines for Malaria Venture, we believe Krintafel will be an important medicine for patients with malaria and contribute to the ongoing effort to eradicate this disease.” Dr David Reddy, CEO, MMV said: “The US FDA’s approval of Krintafel is a major milestone and a significant contribution towards global efforts to eradicate malaria. The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever singledose for this indication, Krintafel will help improve pa-

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tient compliance. We are proud to have worked side-by-side with GSK for more than a decade to reach this point. Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most.” The approval was based on efficacy and safety data from a comprehensive global clinical development P. vivax radical cure programme designed in agreement with the FDA. 13 studies in healthy volunteers and patients directly supported the programme. The primary evidence for the clinical efficacy and safety of the 300mg single-dose, to which more than 800 subjects were exposed, was provided by

three randomised, doubleblind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017. The submission included data analysed from a total of thirty-three studies involving more than 4,000 trial subjects exposed to the 300 mg single-dose and other doses of tafenoquine. With the approval of Krintafel, the FDA awarded GSK a tropical disease priority review voucher. The tropical disease priority review voucher programme is designed to encourage development of new drugs and biological products for prevention

and treatment of certain neglected tropical diseases affecting millions of people throughout the world. The new drug application (NDA) was submitted by GSK to the FDA in November 2017 and a regulatory submission was also made to the Australian Therapeutics Good Administration (TGA) in December 2017. A decision from the TGA is awaited. Approvals by FDA and TGA will be informative to other regulatory agencies for their own approval process in malaria-endemic countries where tafenoquine will be provided as a not-forprofit medicine to maximise access to those who need it most. EP News Bureau

EXPRESS PHARMA

August 1-15, 2018

PHARMA ALLY VENDOR NEWS

B&R celebrates 20 years of growth and innovation with customers Organises CEO Summit 2018

&R Industrial Automation, to mark a glorious milestone of 20 years in India, recently organised ‘CEO Summit 2018’. The summit bought together CEOs from leading companies in machine building for an evening of business presentations, talks from renowned leadership speakers and candid conversations. This summit focussed on taking advantage of the expertise of its attendees with opportunities for participants to share their knowledge and learn from each other. B&R management from Austria and India shared their perspectives on industry trends, business growth with delegates. Peter Gucher, Chairman, B&R India and Member of Management, B&R Austria set the tone of the event and thanked customers and partners for being part of the 20 years journey of B&R India. He focussed on the importance of long-term strong and solid partnership with customers. Commenting on ABB- B&R synergy he stated, “B&R has closed the historic gap within ABB’s automation offering. This is a perfect fit and will make ABB Group the only industrial automation provider offering customers the entire spectrum of technology and industrial automation solutions.” Speaking on the occasion, Jhankar Dutta, MD, B&R India spoke at length on B&Rs focus on innovation, partnerships and collaboration enabling customers to join hands for a successful tomorrow. He mentioned, “Since last 20 years, many machine builders have placed their trust in B&R’s world class products and technologies. We are in pole position today to get the maximum benefit out of technology evolutions and adoption, which are supported by policies of Indian government. We aim at doubling business in

34 EXPRESS PHARMA August 1-15, 2018

coming three years.” Delegates gained inspiration for personal and business growth with insights from R Gopalkrishnan, a senior corporate leader and author of several books. He has led businesses at Hindustan Unilever; and is a former Executive Director, Tata Sons. By giving examples of teashops, blue jays and colloidal science, he distinguished between fulfilment and success. The summit also witnessed the launch of the 3rd edition of ‘automotion INDIA’, a B&R technology magazine, consisting of customer success stories from various industries as plastics, automotive, printing, packaging and pharmaceuticals. The launch took place at the hands of B&R management and customers who contributed towards the articles published in the magazine. B&R also organised a daylong technology conference in Mumbai. The primary objective of the conference was to showcase next generation automation technologies and innovations to customers in Mumbai and nearby regions. Technology focussed presentations and live demos of automation solutions were displayed to extend an avenue to connect with customers and to help them map their future technology requirements. The event brought together over 100 experts from machine manufacturers, system integrators and end users from a wide vari-

ety of industries. Peter Gucher, Chairman, B&R India and Member of Management, B&R Austria, provided a global perspective on automation trends and its impact on industries along with groundbreaking innovations by B&R, which help customers become ready for the future. He spoke on B&R Austria becoming the new global centre for machine and factory automation for the ABB Group. “ABB and B&R are united in their innovation and customer focus. These will be central factors as we evolve together going forward. Ensuring its ability to handle the steadily increasing demand for B&R's advanced automation solutions, ABB is investing in a new R&D centre at B&R headquarters in Eggelsberg as well as expanded production capacity a few kilometers away in Gilgenberg.” Adding further on ABB, B&R synergy, he mentioned, “ABB is investing €100 million in global innovation and training campus in Egglesberg. This ‘factory of future’ will be a new high-tech innovative technology centre and will be fully operational in 2020.” While discussing ambitious plans for the company doubling its business in next three years, Dutta averred, “Since last 20 years, many manufacturers have placed their trust in B&R's world class products and technologies.” Jhankar further deliberated

on what Industrial IoT means to our Indian ecosystem and more importantly how it influences the way we run businesses. He further appreciated the government’s proactive initiatives and stressed, “With government’s ‘Make in India’ initiatives, Indian machine builders and factories are becoming aware about the requirement and benefits of technology and are willing to invest in same.” “B&R is an innovative company, and we are ready with innovative products and solutions to be part of our customers Industrial IoT story,” he added. He also stressed the importance of equipping B&R to handle the market growth, and informed, “To strengthen our market position we are expanding our office space to 16000 sq ft in Pune at the same time investing on manpower across India to match our growth plans.” He opined that B&R aspire to be one of the most customer-oriented company, not only with innovative approach but also with dedicated support. “We have always been loyal to our customers and trust in long term partnerships. To maintain this close cooperation with customers B&R India has launched World-Class Customer Support with a dedicated number. It will also help us in our endeavour to be close to customers and enable them to reach us at all times,” he elaborated. Dheeraj Taneja, Director,

PET PLAST India, spoke at the conference on a topic focusing on benefits of technology for building efficient machines, which was of great help to delegates in understanding the importance of efficiency, quality and productivity. Speaking about collaboration and partnerships he said, “Collaborating with B&R has given us access to latest technology and made our machines competitive on the global market. Our partnership has already led to great success, and we look forward to achieving even more in the future.” The subsequent speakers at the conference presented various topics such as Integration of long-stator linear motors in packaging lines, efficiency in machine development, Edge architecture enabling IT / OT convergence and importance of uniform, open and secure shop floor communications. The presentations showcased that building a digital enterprise will bring about operational excellence and cut costs across the value chain, giving diverse perspective on building smarter machines and factories. With around 100+ delegates including customers and journalists, the conference provided the know-how and an easy path for successful implementation of Industrial IoT for machine builders and factories. EP News Bureau

Waters bolsters mass spectrometry imaging portfolio with acquisition of Prosolia’s DESI Technology Desorption Electrospray Ionization (DESI) imaging technology enables analysis of spatial distribution of molecules in tissue, and thus deeper biological insights

aters Corporation, Prosolia and the Purdue Research Foundation (PRF) announced that Waters acquired exclusive rights to Desorption Electrospray Ionization (DESI) technology for all mass spectrometry applications from Prosolia and PRF. “The acquisition of DESI technology bolsters Waters' portfolio of mass spectrometry imaging innovations, a rapidly expanding MS technique for biomedical research and related applications,” said Chris O'Connell, Chairman and CEO, Waters Corporation. “DESI mass spectrometry imaging provides complementary and actionable data when compared to classical histopathology imaging technologies with major advantages in analysing the molecular fingerprint within a sample, thus delivering deeper biological insights. Ultimately, these insights will lead to better understanding of disease and enable the development of new, more effective medical therapies.” DESI imaging technology uses a charged jet of solvent depositing microdroplets onto a sample's surface where analytes are desorbed into a gas phase at ambient pressure and temperature. Subsequently, they are drawn in and analysed by mass spectrometry. "We at Prosolia are proud of our role in developing and commercialising DESI technology," said Justin Wiseman, CEO, Prosolia. "The potential for MSI analysis using DESI technology is significant because of the quality of the data, the minimal sample preparation required, and the non-destructive nature of the technique allowing for multimodal analysis on a single sample." In connection with Waters’ acquisition of DESI intellectual property from Prosolia and licensing from PRF, Waters and Purdue University, where DESI was invented by a team led by R Graham Cooks, the Henry Bohn Hass Distinguished Professor of Chemistry, have also established a relationship under the terms of a new license agreement. Accordingly, Waters will provide Purdue University with a Synapt G2-Sitime-of-flight mass spec-

trometer to continue to advance research applications of DESI technology. "Today's announcement is an important milestone in the continued growth of DESI to the benefit of scientists around the globe. We congratulate Justin and the Prosolia team for their accomplishments and look forward to collaborating with Waters as it takes DESI into the future," commented Dr Cooks. Waters will continue to support its customers who are already realising the benefits of DESI technology with their Xevo and Synapt time-of-flight mass spectrometers. As the technology transitions from Prosolia to Waters, Prosolia will also continue supply of DESI technology for certain non-Waters mass spectrometer configurations until September 30, 2019. Prosolia will be responsible for and will continue to honour its warranty commitments made prior to Waters’ acquisition of the DESI technology to those scientists and organisations who currently have a DESI source unit on any non-Waters mass spectrometer.

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EP News Bureau

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August 1-15, 2018

PHARMA ALLY

Pall Corporation,BioSciencesCorp launch strategic partnership Expands exclusive distribution agreement with KANEKA Corporation PALL CORPORATION, a global leader in filtration, separation and purification, is partnering with BioSciencesCorp, a consulting company providing novel biologics and biosimilars process know-how and regulatory experience from molecule selection to full commercialisation. Together they will deliver costeffective manufacturing strategies, and efficient upstream and downstream process equipment and facility design solutions for manufacturers. “We are excited to partner with BioSciencesCorp to provide enabling technologies and services that support their customers mission-critical projects,” said Mario Philips, VP & General Manager, Pall Biotech. “Together, we can provide total solutions that today’s drug manufacturers need and make an impact where it matters most: with the patient.” Leveraging deep industry

expertise, the BioSciencesCorp team aligns with customers at all phases of the process from concept to commercialisation. Customers benefit from smallcompany style, speed, and service and support from the initial modelling phases through implementation. The team is also available to help with critical aspects of process integrity, such as quality by design, process analytic technologies, and regulatory guidance. “Starting from feasibility phases through to transfer and training activities, BioSciencesCorp was built to offer quality guidance and support to each customer,” said Daniel Chang, Executive Director and Founder, BioSciencesCorp. “Aligning with Pall Biotech deepens our ability to provide truly end-to-end, integrated solutions to customers from consultation to clinical development and com-

mercial manufacturing.” This strategic partnership provides drug manufacturers with direct access to Pall Biotech bioreactors, mixing and storage product lines, single-use downstream technologies, consumables, and interunit operation connections. Regardless of the type of project, customers also have the option to work with Pall service teams throughout process design and development to ensure process success. The company also announced the extension of a consumables distribution agreement with KANEKA Corporation. In addition to flagship KANEKA KanCapA Protein A chromatography sorbents, the Pall Biotech business unit features the company’s next generation KANEKA KanCapA 3G sorbent for the primary capture of monoclonal antibodies (mAbs) from clarified cell culture. The sorbents are avail-

able in off-the-shelf bulk format for use with large columns, such as Resolute AutoPak columns, and a range of pre-packed columns. “Increasing demand for more targeted and personalised medicines is driving growth and development in the mAb manufacturing market. In combination with our industry-leading portfolio of downstream process equipment, KANEKA KanCapA 3G sorbent offers a complete solution to customers looking to make these products,” said Mario Philips, VP and GM, Pall Biotech. “Through the collaboration with the KANEKA team we are able to ensure consistency, quality and reliability with an industry-leading sorbent that enables customers to continuously improve their bioprocesses.” The full KANEKA KanCapA line of products is based on a robust matrix that enables the high productivity

affinity capture of mAbs and related biomolecules using a proprietary alkali stable rPrA ligand. Designed with a combination of proprietary recombinant ligand and a highly cross-linked cellulose base matrix, the new KANEKA KanCapA 3G sorbent exhibits enhanced binding capacity, an excellent elution profile, and advanced impurity removal properties when compared with other market sorbents. Furthermore, KANEKA KanCapA products are manufactured in a state-of-the-art facility in Japan to meet and exceed regulatory standards, deliver exceptional results, and guarantee supply chain security. The distribution agreement between Pall and KANEKA enables market reach expansion for KANEKA products which, ultimately, helps to improve global health. EP News Bureau

Avantor announces new brand identity New identity signals continued integration with VWR and ongoing commitment to customers FOLLOWING THE acquisition of VWR in 2017, Avantor introduced a new logo and visual identity, signalling the company’s position as a leading global provider of products, services and solutions for professionals in the life sciences and advanced technology industries. “This marks an exciting milestone for Avantor as our integration with VWR continues,” said Michael Stubblefield, CEO, Avantor. “We’re transforming our global visual presence to give a fresh,

36 EXPRESS PHARMA August 1-15, 2018

distinctive expression of the new Avantor and our mission to set science in motion to create a better world.” The new visual identity captures two strong legacies in a unified symbol. The fluid curve symbolises the agility of a company that is always

ready to adapt to customer needs. It is the infinite path of scientific discovery, signifying the momentum that propels Avantor into the future. Following the rebranding, Avantor will continue as the corporate name and entity, while the VWR name remains

as the channel brand, representing the primary ordering platform for customers. The new visual identity will be implemented across all aspects of the company, presenting a common, aligned identity that reflects the integration of the two businesses. The new identity will be rolled out over time on all company platforms, including facility signage, web properties, promotional materials, product labels and documentation. The change to the logo will

not impact the company’s ecommerce functionality, product quality or specifications, product availability or service delivery performance. Stubblefield added, “With this new logo and visual identity, we are launching a global brand that stands for the things that matter to our customers: quality and choice, trusted expertise, collaborative service, and innovative, customised solutions.” EP News Bureau

PHARMA ALLY

Gerresheimer extends business model in OEM for drug delivery platforms The company has secured two new major contracts: one for the manufacture of inhalers and another for prefillable syringes for a major heparin producer WITH THE acquisition of Sensile Medical, Switzerland (Sensile Medical) under a share purchase agreement signed recently, Gerresheimer is extending its business model in the direction of an Original Equipment Manufacturer (OEM) for drug delivery platforms with digital and electronic capabilities for pharmaceutical and biopharmaceutical customers. Sensile Medical develops innovative drug delivery products and platforms, including digital connected capabilities. It is already working successfully with customers on the development of devices for diabetics and patients with heart complaints. Depending on the attainment of contractually specified milestones,

In the years 2021 and 2022, Gerresheimer expects—again, excluding Sensile Medical—that both revenues and the adjusted EBITDA margin will increase by two percentage points beyond the usual rate of growth while capital expenditures will return to around eight per cent the purchase price will be a maximum of EUR 350m. The initial payment is EUR 175m. Independently of this, Gerresheimer has secured two new major contracts: one for the manufacture of inhalers and another for prefillable syringes for a major heparin producer. At the same time, Gerresheimer has lost a sig-

nificantly smaller order in the inhaler business resulting in a restructuring that will affect the plant in Küssnacht, Switzerland, which is to be closed by the end of 2019. As a result and excluding Sensile Medical, there are changes in the planning of capital expenditures, profitability and revenues. For the years

2019 and 2020, capital expenditures are expected to be higher by two to a maximum of four percentage points of revenues at constant exchange rates, among other things for the capacity expansion at the plant in Horsovsky Tyn, Czech Republic; further automation; and a new plant in Eastern Europe. At the same time, Ger-

resheimer anticipates that this will lead in 2019 and 2020 to an approximately one-percentage-point reduction in the adjusted EBITDA margin (relative to the financial year 2017) as a consequence of low-margin revenues in the engineering and tooling business for the new major orders and of increased expenditures for relocation, employee training and production start-up/ramp-up. In the years 2021 and 2022, Gerresheimer expects— again, excluding Sensile Medical—that both revenues and the adjusted EBITDA margin will increase by two percentage points beyond the usual rate of growth while capital expenditures will return to around eight per cent. EP News Bureau

Cognizant leads the pack in life sciences digital services: New Everest Group Assessment New PEAK Matrix report names Cognizant a leader in market share, vision and capabilities COGNIZANT HAS been named one of the top providers of digital services for life sciences organisations in a new PEAK Matrix report by consulting and research firm Everest Group. This is the first time Everest Group has assessed companies specialising in life sciences digital services across North America, comparing the capabilities of 23 service providers. Cognizant was highlighted in the report for having the largest market share and achieving top marks for its industry vision and capabilities. “The North American life

sciences industry is at an inflection point as it adopts digital technologies to make a conscious push towards precision medicine and other strategic bets,” said Abhishek Singh, Practice Director, Everest Group. “Cognizant has capitalised on its life sciences pedigree to pursue partnerships and build capabilities that enable the digital journeys on which enterprises are embarking.” “Life sciences companies are fundamentally reimagining their business models across the value chain to continue to advance science and improve patient lives,” said Bhaskar

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This is the first time Everest Group has assessed companies specialising in life sciences digital services across North America, comparing the capabilities of 23 service providers Sambasivan, Senior Vice President and Global Market Leader for Cognizant’s Life Sciences business. “Our work with all of the leading life sci-

ences companies highlights the dramatic digital shift taking place in the industry and we are appreciative of this recognition from Everest Group.

“Cognizant is at the forefront of helping biopharmaceutical and med-tech companies transform their businesses through end-toend digital solutions that combine consulting, process operations and technology services. Our investments in products and common industry solutions such as Shared Investigator Platform, Smart Trials and Medvantage are helping our clients accelerate this transformation more effectively and better compete in a complex and changing business environment.” EP News Bureau

EXPRESS PHARMA

August 1-15, 2018

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 quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air

38 EXPRESS PHARMA August 1-15, 2018

parent 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

pressure ◗ Designed to fit inside the

columns ◗ Self-supporting construction

◗ Minimises air leakage ◗ Can be equipped with trans-

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

PHARMA ALLY

Industrial Equipwash launches products for various sectors Hose down wash unit IEWI hose down unit (Mixing Battery) provides instantaneous hot water economically by mixing steam and ambient water to the required temperature through a simple turn of a knob. The mixing battery is supplied with isolation valves, check valves, union joints, strainers and

Hot and cold water hose stations and mixing Units produce hot water instantly and keep on producing it as long as there is a constant supply of steam and cold water. This unit is equipped with a dial thermometer which indicates the temperature of the wash water. By means of the control valves the user can adjust the unit to produce hot water of the desired temperature if for some reason the cold water supply fail, the steam is instantly shut off. This action is positive and automatic and does not rely on thermostats or electrical devices. When the unit is properly maintained, this safely feature eliminates the hazard of steam burns. This unit comes fitted with 3 to 5 metre of high pressure water hose. Within this complete wash down unit, the operator can do a better and more economical clean-up job since the unit furnishes a steady supply of hot water at the desired temperature and the spray nozzle allows him to regulate the water from a solid jet to a fine spray. Moreover, there is no waste of water since the flow stops the instant the spray nozzle lever is released.

sembled by means of clamping and hygienically sealed with a special seal ring. A guide plate guides the spring valve loaded valve plug with an O-ring seal. The available sizes are ½”, ¾”.1”.1.1/4”, 1.1/2”, 2”.2.1/2”, 3” and 4”. The MOC will be SS 304,304L,316 and 316L. end connection shall be triclover, flange,sms,DIN,SCR etc. surface finish 0.4 Ra. ing the lever. A slight spray is sent forth with slight pressure on the handle. The nozzle automatically shuts off the moment the lever is released, thereby eliminating water wastage. The nozzle is provided with molded rubber jacket to avoid thermal shock. The unit operates on water max pressure of 10 kg/cm². Inlet hose connections offered are ½" and¾”.

Non – return valve is designed to prevent reverse flow with positive shut off. These valves are specially designed for sanitary applications, it is offered in plug type design. The valve opens when the pressure below the valve

Low initial cost, low maintenance, no complicated mechanism to get out of order, no expensive hot water steam needed, can be easily installed in the part of the plant where steam and water lines.

Water saver nozzle Heavy duty, stainless steel, Water Saver Nozzle is designed for cleaning applications in pharma, food, dairies, breweries, beverage and cosmetics. It does a better job with the least amount of water. The precision made nozzle enables the operator to get any type of stream of water to do jobs by simply press-

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(For Pharma, biotech, food, beverage, hospitals, clinic labs and arport) Based on customer needs, Industrial Equipwash have developed IPA dispenser (Hand Sanitizer) that automatically

Aseptic non-return valves

Advantages

thermometer to know the temperature of the emerging hot water. Mixing battery provides industry with cheap hot water wherever steam is available, along with water. It incorporates a hydraulic fail safe device, so that when correctly installed and maintained, no steam regardless of its pressure can enter the mixing chamber until the water flows to raise the steam valve of its seat. When turned off at the outlet, there is an immediate and positive shut-off.

Automatic IPA dispenser (Hand Sanitiser)

plug exceeds the pressure above the plug and the spring force. The valve closes when pressure equalisation has been achieved ,can be mounted horizontal or vertical position. A higher counter pressure will press the valve plug against the seat. The valve body is in two parts, as-

dispenses alcohol based hand sanitizer (70 per cent isopropyl alcohol). The dispenser prevents from touching unhygienic levers, taps knobs and soap cakes, thus preventing cross contamination and maintaining complete hygiene. Since they operate automatically, production areas / QC labs / packaging areas /clean rooms /wash area are always hygienic. Operation Hands can be put into the unit’s interior as shown in picture. The sensor detects the hand and automatically dispenses 0.5ml to 2ml (setteable volume) sanitising solution (hydro alcohol based ) which rapidly evaporates on

rubbing hands. Advantages Efficient: Pathogens of the hands are eliminated by the disinfectant instantly. Fast: The cleaning Economical: Only 0.5ml to 2ml of preset disinfectant utilised per cleaning cycle. Convenient: Easy to install at wall or table, and operate and maintain. Durable: The body is of noncorrosive, stainless steel construction.

Technical specifications Electric Supply 220 V AC, 60 Hz or 24 V AC Dimensions (W X D X H ) 300mm X 200mm X 320mm Weight 9.25kg Tank capacity 500ml to 2000ml. Volume of spray cycle 0.5ml to 2ml/cycle Note : 1. Since improvements are made from time to time, dimensions and specifications are subject to change without prior notice. 2. The disinfectant solutions is hydro alcoholic based. The equipment can’t be used for soaps or gels. The IPA solution should be free of solid particles as these may choke the spray nozzles. Contact details Industrial Equipwash 8/B, Surat Singh Industrial Estate, Near Agarwal Industrial Estate, Captain Suresh Sawant Marg, Off. SV Road, Jogeshwari (W), Mumbai - 4000 102 Maharashtra Mob: 09869231815Tel No.022-26797941/ 26798066. Email us on : iewisvraja@yahoo.co.in; iewi@mtnl.net.in, iewisuvarna@yahoo.in, iewi@vsnl.net Website : www.iewi.net

EXPRESS PHARMA

August 1-15, 2018

PHARMA ALLY

Mack Pharmatech offers cost-effective PLC-based stability chambers with European standard MACK PHARMATECH has been working continuously in the field of manufacturing pharma and lab equipment since 1999. The company offers cost effective PLC-based stability chambers with European standard 'CE' in different capacities. The humidity chambers temperature range is 20°C to 60°C, humidity range: 40 per cent RH to 95 per cent RH, Accuracy: ±0.2°C & ±2.0 per cent RH, uniformity: ±1.0°C & ±3.0 per cent RH, Control System: PLC (Allen Bradly) and our stability chambers are suitable for different ICH test conditions like 25°C & 60 per cent RH,

30°C & 65 per cent RH, 40°C & 75 per cent RH, 30°C & 75 per cent RH. Also providing specially designed chambers for low humidity conditions such as 25°C & 40 per cent RH, 40°C & 25 per cent RH and 30°C & 35 per cent RH. Mack Pharmatech is the only company which gives all equipment with PLC Based Control System,21 CFR Software, Touch Screen Display [HMI], Stand By Refrigeration System, Stand By Humidity System, Imported Stand by Hygroflex sensor, GSM Technology, Hooter System, Pass-

word Protected Door System, Full View Glass Door, GMP Model, Bullet feet leveling legs, Tray Spacing every ½ adjustable and many more features. Contact details MACK PHARMATECH Corporate / Factory Office B-48, Malegaon MIDC, Sinnar, Dist.-Nasik, Maharashtra 422 113, Mobile : +9193 2596 5656 Telefax : +91-02551-230877 URL : www.mackpharmatech.com E-Mail : sales@mackpharmatech.com

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 Kailash Purohit The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9552537922 Fax: 044- 28543035 Email id: kailash.purohit@expressindia.com

BANGALORE Kailash Purohit The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Mobile: +91 9552537922 Fax: 080- 22231925 Email id: kailash.purohit@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.

40 EXPRESS PHARMA August 1-15, 2018

PHARMA ALLY VALUE ADD

Rotating Bed Reactor (RBR) – Aconcept and innovation Heterogeneous reactions quick, easy and reproducible - Scalable from lab to production SPINCHEM, Sweden has turned the slow conventional heterogeneous and viscous reaction into a fast and easy one. The Rotating Bed Reactor (RBR) technology is the latest and modern one making revolution in biocatalysis, reactor engineering, downstream processing, process development and reaction screening etc. The major advantages in RBR are, short reaction time, simple to scale, long catalyst life time, easy to automate, no tedious filtrations and perfect for screening.

A clever concept The SpinChem’s RBR holds the solid phase as a packed bed and rapidly aspirates the reaction solution from the bottom of the vessel, perco-

uids that are immiscible or of different viscosity, or for reactions demanding distribution of dissolved gases.

by the spinning RBR, using carbon or ion exchangers in downstream processing. (Fig 2) If the existing set-up makes it impractical to use the RBR in-tank for batch processing, SpinChem offers other solutions, such as flow systems, where the RBR is used in a separate vessel connected to the main tank. The SpinChem RBR can also be used in connected systems of reactor vessels, where the RBR is used in one or more of these vessels. Simultaneous extraction of two dyes selectively onto different resins:

Revolutionise your reactions with RBR A rotating bed reactor is designed to prevent disintegration of solid phase particles by retaining them inside a rotating cylinder during the reaction span. This minimises solid phase debris even at high speeds, which would normally occur due to mechanical forces when using stirred tank reactors. The SpinChem design is flexible and can be used for heterogeneous reactions with numerous types of solid phases, including immobilised enzymes, encapsulated cells, ion exchangers, or for

Fig 2. Downstream processing

acids as well as the synthesis of esters and amides. Areas of lipase-catalysed reactions include food processing, synthesis of fine chemicals and production of bio fuel. The immobilisation of enzyme will allow for easier recycling, manipulation and separation of the enzyme, as well as an increase in its thermal and operational stability. The RBR ensures easy in-line monitoring of the process, as well as a more efficient recycling of the solid phase particles, making the RBR a cost and time efficient alternative to conventional methods for immobilised enzyme biocatalysis.

Reactor engineering Fig 1. Spinchem RBR mixing

lates it through the solid phase and quickly returns it to the vessel. By intelligent design of the SpinChem RBR and vessel, the axial mixing and convective transport are maximised. The resulting efficient mass transfer minimises reaction time and boosts product yields even with liq-

purification using metal scavengers, active carbon and water adsorbents.

Bio catalysis The most frequently employed group of biocatalysts is lipases. These enzymes are very versatile, facilitating the hydrolysis of lipids into fatty

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One of the most difficult issues in heterogeneous reactions is achieving contact between the reagents in the two phases — a phenomenon known as mass transfer limitation. The reagents in the liquid phase must be brought to an active site on the solid phase through transport of the liquid medium relative to the solid particle. In absence

of any stirring to create convective flow, this transport only takes the form of diffusion, which is a very slow process. The RBR is a modern alternative to the traditional reactor types which leads to significantly greater reaction rates in mass transport limited cases. Since the solid phase is contained within the RBR it may also be regenerated or reused in-situ for another reaction step without any time-consuming filtration in between.

Downstream processing To reach a satisfactory quality of the pharmaceutical or cosmetic or food end-products, there is often also a need for downstream processing, including purification, extraction and polishing. Two solid materials commonly used for such heterogeneous procedures are activated carbon and ion exchangers. Here is an externally connected RBR can pump and process large liquid volumes by the convective flow created

Fig 3. Different dyes extraction

A mixture of red and blue dyes with different chemical properties can be selectively extracted onto different adsorbents within the same run using a RBR. The dyes were separated based on ionic and hydrophobic interactions, respectively. SpinChem’s fields of expertise include chemistry, engineering, experimental design, solid phase materials, and fluid flow simulations. Through rapid in-house prototyping, testing, simulating, analysis and optimisation, SpinChem is able to develop clever, custom-made solutions to fit your processes and applications. Contact details: info@smartlabtech.net & sks@smartlabtech.net

EXPRESS PHARMA

August 1-15, 2018

PHARMA ALLY

Lupin reduces air-conditioning load through fresh air pre-cooling Lupinâ&#x20AC;&#x2122;s management is happy with the results of the HMX-PCU and is looking forward to implementing the solution in other manufacturing facilities as well

Each AHU is designed to have a specific provision for 4- 5 % fresh air intake and the rest 95 per cent is re-circulated from the room

LUPIN reduced the tonnage of their air conditioning system by integrating HMX's fresh air precooling, resulting in substantial savings in their overall cooling costs. Psychrometric Representation of the Cooling of Incoming Fresh Air without HMX-PCU

Background Lupin is a transnational pharmaceutical company headquartered in Mumbai. Lupin's businesses encompass the entire pharma value chain, ranging from branded and generic formulations, APIs, advanced drug delivery systems to biotechnology.

Solution To ensure that the requirement of 4-5 per cent fresh air in each room is met while simultaneously reducing the TR load, one common unit of HMX-PCU was installed in the AHU bay. The 8000 CFM HMX-PCU is an indirect evaporative cooling (IEC) module which sensibly pre-cools the fresh air before it enters the AHUs, thereby reducing the overall load on the chilled water system.

Challenges Lupin's facility in Pune, India, is a state-of-the-art facility for tablet manufacturing. The tablet manufacturing process requires strict temperature control and very low relative humidity (RH), which is why pharma companies generally use airconditioning systems to maintain the temperature and dehumidifiers for RH control. The facility has clean rooms on the ground and first floors for various processes. These clean rooms are cooled by 12 dedicated AHUs (air handling units) with a capacity of 15,000 CFM each. These AHUs are stacked together on a common service area on the second floor and are connected to a chilled water system. For maintaining a healthy indoor air quality (IAQ) inside the rooms, each AHU is designed to have a specific provision for 4- 5 per cent fresh air intake and the rest 95 per cent is re-circulated

42 EXPRESS PHARMA August 1-15, 2018

from within the room. Since the fresh ambient air is generally of higher temperatures than the recirculated air, cooling this fresh air places a significant load on the chilled water system.

Result

Psychrometric Representation of the Cooling of Incoming Fresh Air with HMX-PCU

Schematic of Lupin, Pune, Service Floor

The HMX-PCU has proved to be an eco-friendly way to reduce tonnage load on the air-conditioning system. In the peak summer, HMX-PCU can save up to 15 per cent of the operational cost required for running the entire air-conditioning system. Lupinâ&#x20AC;&#x2122;s management is very happy with the results of the HMX-PCU and is looking forward to implementing the solution in other manufacturing facilities as well. Contact details ATE Enterprises (Business Unit: HMX) T: +91-80-2372 1065/ 2372 2325 E: ambiator@hmx.co.in W: www.ategroup.com/hmx

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PVC RIGID FILM FOR BLISTER FORMING

TRIPLEX LAMINATE

US FDA Type III DMF: 032495

US FDA Type III DMF: 032497

ALU ALU LAMINATE

PVdC COATED PVC FILM

US FDA Type III DMF: 032494

US FDA Type III DMF: 032496

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

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

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

SLITTER COATING LINE

Ÿ Producing 60 Micron PVC Film by Direct

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

Manufacturing site Ÿ 29000 Sq. Mtr. of Manufacturing Area

LAMINATOR

Ÿ 6000 Sq. Mtr. Built-up Area

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

August 1-15, 2018

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Stainless Steel Cleanroom Tools SANITARY HOSES & FITTINGS Performance matched to your production needs

Replacing Carbon Steel Tools With Steritools™ Eliminates Risk And Should Be Considered A Standard Operation Procedure For Any Modern Facility.

lHemostat Forceps & Tweezers lBall Pein Hammer & Hamallet lHex Keys (allen Keys) lIce Pick, O-ring Tool, Pointer lKnives lNut Drivers lPliers lTool Box

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Pharma Biotech Food & Beverage Chemical and Petrochemical

Many More....

June Range of Products for free download look for JUNE4GMP

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August 1-15, 2018

Shah Brothers Email:priyanka@shahbros.com ISO 9001 - 2015 Certied

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Improve product quality, reduce costs with the Nordson ProBlue® ATS Melter

Nordson ProBlue® ATS Melter

Nordson’s new Adhesive Tracking System (ATS) measures and records the adhesive consumption per product, and triggers an alarm if pre-set limits are crossed. Product quality, reliability and safety are of immense importance for the pharmaceutical industry. Insufficient or excessive adhesive directly affects the bond strength and product quality. Any unsealed cartons leaving a factory could cause costly rejects in the market. Nordson’s ATS feature offers reliable and cost-effective tamper-evident packaging by enabling a user to: Monitor adhesive consumption per product, thus controlling costs and minimizing waste. Track out-of-tolerance products with operating alarms and line stops, thereby improving product

quality and ensuring reliably sealed cartons. Analyse historical data to improve processes of a production line.

Learn more about ATS Solutions

ATS retrofit kits are also available that can be added to the existing Nordson melters. Contact us today at +91 80 4021 3600 or nordsonindia@nordson.com for further details.

www.nordsonadhesive.com

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Nordson India Private Limited 143A, Bommasandra Industrial Area, Bangalore 560 099

August 1-15, 2018

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OSMOMETER 3250

Milk Cryoscopes Available

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

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

The Best Natural Astaxanthin

“

„

OUR MISSION is to make the world healthier and happier.

Protective Effect of Antioxidants on Human Fibroblasts Astaxanthin vs. other antioxidants Human dermal ﬁbroblasts were pre-incubated with antioxidants before exposure to singlet oxygen, and cell viability was measured to compare the protective eﬃcacy.

Range of Product AstaREAL Oil, 5% / 10% AstaREAL Powder, 2.5% / 4%

Antioxidant concentration level: 10 μM

no exposure

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Vitamin C

Areas of Clinical Study on Natural Astaxanthin

Alpha- tocopherol Lutein Beta-carotene

Astaxanthin 20

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angwal 50

Since 1994, only AstaReal cultivates algae in a completely indoor. The controlled process results in the highest quality, purity and most eﬃcacious astaxanthin.

AstaREAL CLEAR100, 1% Liquid

Coenzyme Q10

AstaReal’s Unique Photobioreactor Cul va on

AstaREAL CWD Beadlet

Alpha-lipoic acid

CoQ10

Living longer! Living better! Living with spirit undimmed by age or disease throughout your life! This is how we deﬁne happiness. We believe the fundamental way to “be you” at any stage of life is to become healthier as you grow older by building resilience against oxidative stress and chronic inﬂammation.Astaxanthin is the anti-aging treatment that lets you shine brightly without burning out!

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Neurovascular Protection Eye Fatigue Relieve Skin Aging Defense Immune System Booster Liver Health And Metabolic Syndrome Cardiovascular Health Lowering Gastric Inﬂammation Anti-diabetes / Kidney Protection Muscle Resilience Fertility Capillary Circulation

Comprehensively backed by safety and toxicology studies. Nearly 20 years on the market. US FDA GRAS, DSHEA NDIN and many more Holder of the largest number of patents for astaxanthin uses Health professional recognition and athlete recognition Sold in more than 30 Countries and in leading brand supplements GMP inspected and pharmaceutical manufacturing expertise Proliﬁc Research & Development activities

Contact for more information Gangwal Chemicals Pvt. Ltd. :

706-707, Quantum Tower, Rambagh Lane, Behind State Bank Of India, Malad (west), Mumbai - 400064 Tel.: +91 22 2888 9000, Fax: +91 22 2883 5347, Email: info@gangwalchem.com, Web.: www.gangwalchem.com

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5 Parameter Tablet Tester

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ISO 9001 - 2015 Certied

AETRON TLC/HPTLC PHOTO DOCUMENTAION SYSTEM (MODEL- ELITE MINILUMINOUS) PRODUCT CODE- AE-04

Programmable tolerances with visual alerts of T1, T2 and Plausibility limits

21 CFR

Part 11 Compliant

ELECTROLAB (India) PVT. LTD. Tel : +91 - 22 - 4041 3131 / +91 - 22 - 4161 3122 • Website : www.electrolabgroup.com • E-mail : sales@electrolabgroup.com

HVA

Technologies Private Ltd.

TOP ILLUMINATION: Short Wave 254nm +Long Wave 365+Visible TRANS Illumination: Visible INBUILT. HIGH RESOLUTION HDR CAMERA along with IDS software WITH AUTO RF CAL, ANNOTATION, AUDIT TRAIL. 21 CFR PART 11 Compliance software.

TLC/HPTLC SAMPLE APPLICATOR (Model - SPRAYLIN) PRODUCT CODE- AE-05 HIGH RESOLUTION 0.1μl Easy selection of delivery speed as per polarity. Superimpose facility. 35 fixed method. PC controlled. 21 CFR PART11 Compliance software. OUR PRODUCTS UV CABINET Colony Counter

UV Trans Illuminator Development Chambers.

Contact: AETRON H-303, 3rd Floor, Sharad Industrial Estate, Lake Road, Bhandup (West) Mumbai - 400078. Email: aetroninfo@gmail.com Tel.: 022 25964133, Mobile: 9152614381

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

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To Advertise in

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

S. P. PRODUCTS

PHARMA EQUIPMENTS AT IT'S BEST

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S.S. STEP LADDER

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S.S. CABINET FOR FBD BAGS STORAGE

S.S. TROLLEY FOR HAND DISINFECTANT / HAND GLOVES / MASK /ROLLER

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S.S. CABINET FOR BLISTER S.S. LOCKER S.S. VISITOR CHANGE PART / STRIP CH PART / FOR KEEPING APPRON CABINET POLYBAG STREET GARMENT

• All products are custom made & available in 304, 316 & 316L Quality with optional Matt & Mirror finish. • We undertake the side work of Cladding of Machinery & others.

August 1-15, 2018

S.S. CABINET FOR MULTIMILL SIEVES

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Contact: Mr. Kiran Shah / Mr. Chirag Shah

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

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KILITCH HEALTHCARE INDIA LTD. Avoid the

Harmful Side Effects of Preservatives

India’s first ever Preservative Free Ophthalmic Manufacturing Facility Widely accepted by Ophthalmologist

Patented Pure Flow Technology For contract manufacturing contact: Kilitch Healthcare India Ltd. 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai – 400022. Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957 www.kilitchhealthcare.com info@kilitchhealthcare.com

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PHARMA LIFE AWARDS

Express Healthcare announces Best Hospital Pharmacy Citations 2018 Honours seven hospital pharmacies for excellence in onsite pharmacy practices

Winners at the Best Hospital Pharmacy Citations 2018

Usha Sharma New Delhi

xpress Healthcare, a leading monthly healthcare publication from the Indian Express Group hosted the second edition of Best Hospital Pharmacy Citations 2018, during the third edition of Healthcare Senate in Delhi on July 13, 2018. Glenmark Pharma partnered with Express Healthcare in an endeavour to recognise the pivotal role of hospital pharmacies in health-

GCS Medical College, Hospital & Research Centre receives the citation in the multi-speciality category

To subscribe: bpd.subscription@expressindia.com

Sri Ramakrishna Hospital, Coimbatore receives the citation in the category multi-speciality category

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Apollo Gleneagles Hospital, Kolkata receives the citation in the category multi-speciality chain hospitals

care delivery. The event began with the welcome address, given by Viveka Roychowdhury, Editor, Express Healthcare and Express Pharma. In her address, she welcomed the delegates and jury members and explained the methodology of Best Hospital Pharmacy Citations 2018. The citations evaluated and rewarded the most future ready corporate hospital pharmacies which have put in place best practices and systems in terms of operations, quality of care, patient safety and counseling, and health outcomes. The jury discussed and decided on parameters and criteria to evaluate the nominations received. The criteria included NABH accreditation, the presence of a structured formulary, methods to handle medical errors, patient counseling mechanisms, and stock expiry management matrix. The nominees filled up forms giving details on the criteria. The jury members evaluated the nominations to arrive at the final list of seven hospital pharmacies, in two different categories; multi-specialty and multi- specialty chain hospitals. The award presentation ceremony followed by her speech and joined by AG Prasad, Vice President-Sales and Marketing, Glenmark, Chairperson of Jury N Udupa, Professor and Research Director (Health Sciences) Manipal Academy of Higher Education, Manipal, Dr Sujit Paul, Managing Director, Sarvagun Ausadhi, Pankaj Bector, Procurement Specialist [Drugs & Medical Equipment),Stores Officer] Na-

66 EXPRESS PHARMA August 1-15, 2018

Aster Medcity, Kochi receives the citation in the category multi-speciality chain hospitals

Bhatia Hospital bagged the citation in multi-speciality category

Saifee Hospital receives the citation in multi-speciality category Winners