Express Pharma (Vol.12, No.20) August 16-31, 2017 by Indian Express

VOL. 12 NO. 20 PAGES 92

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Pharma Technology Review

Making sense of serialisation

16-31 AUGUST 2017, ` 40

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CONTENTS Vol.12 No.20 August 16-31, 2017

MAKING SENSE OF SERIALISATION

Chairman of the Board Viveck Goenka

With more than 40 countries already implementing or set to enforce their serialisation mandates by 2018, are pharma exporters from India geared up to face this challenge? | P52

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

National Design Editor

MARKET

EXPERTS URGE ADOPTION OF INTEGRATIVE MEDICINE

IPM CLOCKS ` 115,725 CR IN JUNE 2017

INDIAN PHARMACOVIGILANCE DAY 2017 CONFERENCE HELD IN HYDERABAD

Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

P43: RESEARCH UPDATES Stopping statins after stroke may increase second-stroke risk

MANAGEMENT

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P50: REPORT Pharma has highest number of digital primes: India Digital Health Report 2017

VEG MEDS: YAY OR NAY?

PHARMA TECHNOLOGY REVIEW

P51: NEWS CAMS partners with hCue

P62: INTERVIEW IEC plans to develop SOPs for standard ICCCS courses

CORRIGENDUM This is with reference to release of ACE Technologies advertisement in Express Pharma Issued in the month of August 1-15 2017. This is to inform that there has been an inadvertent mistake in the advertisement published by ACE Technologies in August 1-15, 2017 issue of Express Pharma wherein, Mediseal Company logo has been published by error in the advertisement. Correction : Currently, ACE Technologies is not an authorised distributor for “MEDISEAL”. - ACE Technologies

SERIALISATION IN OPERATIONAL LIFE-CYCLE AND VALUE REALISATION

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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EXPRESS PHARMA

August 16-31, 2017

EDITOR’S NOTE

Surviving serialisation

t was way back in 1963 that the US FDA finalised the first version of Good Manufacturing Practices (GMPs) for finished pharmaceuticals. There have been periodic revisions to keep up with technology as well as increasing global trade of pharma products. Similar versions of the US FDA’s GMPs have been since adopted in other countries, keeping in mind their unique challenges. In time, regulators of most countries agreed to work towards harmonising their standards to avoid discrepancies. The global serialisation initiative, started half a decade later and is still barely out of its first decade. Thus in comparison, serialisation/track and trace is at a relatively nascent stage. The first important legislation aimed at securing the pharma supply chain was the US Drug Quality and Security Act in November 2013. The US was and still is the largest pharma market, so this Act impacted all exporters to the US. In spite of the tremendous capital expenditure involved, they had to move to change their systems or lose lucrative export revenue. The move to establish national and then international electronic systems to identify each medicine, and then track and trace each pharma product, from the time it leaves the manufacturer's facility, to wholesalers, distributors, and finally chemists, the point of sale to the patient, is a good step towards patient safety but is daunting in terms of operational feasibility. Ironically, though serialisation started as a move to standardise one aspect of a pharma product's packaging to detect substandard/ counterfeits, different countries chose their own standards. Thus India, as the pharmacy of the

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12 EXPRESS PHARMA August 16-31, 2017

India,as the pharmacy of the world,with a geographically vast export footprint,has to contend with multiple serialisation requirements

world, with a vast export footprint, contends with multiple serialisation requirements. To further complicate matters, pharma manufacturers in India have different specifications for the domestic market. The serialisation initiative is today at the stage of harmonisation, with key export country mandates, like the US and the EU, rolling out by November 2017 and 2019 respectively. (To know more, read the story, Making sense of serialisation, in the August 16-31, 2017 issue, pages 52-56) Most big pharma companies are well placed to meet the serialisation deadlines and are today looking at serialisation as a strategic business tool. For instance, at the chemist level, in fact, across the retail trade, spanning stockists, wholesalers and distributors, the data generated can be used as an inventory management tool. For the manufacturers too, it helps better inventory management as the barcodes include data on the origin, shelf life and batch number of the product. Much like every supermarket can access the expiry dates and sources of all products on their shelves. From food and garment retail, to the aerospace industry, the pharma sector has many precedents when it comes to serialisation. While the ultimate goal is common, countries have chosen their own paths which is adding to the confusion and will ultimately lead to loss of legitimate business. Differing standards could also create gaps in the supply chain which could be exploited. Let's hope that these are resolved sooner rather than later. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET POST EVENT

Experts urge adoption of integrative medicine Expound on the need for clinical integration, basic science studies, and application of new technologies to make integrate ayurveda with allopathy

mrita Samyogam 2017, hosted in collaboration by Amrita Institute of Medical Sciences and Amrita University’s School of Ayurveda, saw allopathic doctors, Ayurveda practitioners and modern scientists come together on a common platform to discuss and deliberate on strategies to integrate Ayurveda with Allopathy. Experts spoke on the potential of integrative medicine to enhance the management of cancer, auto-immune diseases like arthritis, diabetes, neuro-degenerative diseases, and mental health. They also highlighted the need for clinical integration, basic science studies, and application of new technologies to improve the reach and effectiveness of integrative medicine. Evidence-based practice guidelines for cross-referrals and combination therapy, understanding the biological mechanisms underlying integrative care, and integration of modern technological tools in Ayurvedic diagnostics, treatment procedures and drug delivery were some of the major topics under discussion at the event. Rajesh Kotecha, Special Secretary, Ministry of AYUSH, the Chief Guest at the event said, “The government is setting up a nationwide AYUSH grid connecting all hospitals and research labs to record case histories and observations so that a huge amount of evidences can be generated through data analytics about the efficacy of Ayurveda.”

EXPRESS PHARMA

August 16-31, 2017

Dr P Ram Manohar, Research Director, Amrita Centre for Advanced Research, said, “We need to develop integrated clinical trials and integrated practice guidelines for practitioners across different healthcare systems.” Prof Shantikumar Nair, Director, Centre for NanosciencesMolecular Medicine, Amrita University said, “In Ayurveda, treatment is through natural herbal medications which can have significant potency and potential for substantial improvement in several disease conditions as well as less deleterious side ef-

fects. Their main drawback of Ayurveda is the lack of scientific validation and data documentation as per evidencebased criteria, which prevents its better acceptance and recognition.” Dr Christian Kessler, Internal Medicine Specialist, Charite Medical University, Germany said, “While modern biomedicine is currently rediscovering such inter-relationships in disciplines like psycho-neuro- immunology or psychosomatics, this has been at the heart of Ayurveda for thousands of years.” A unique product, a band-

age which utilises nanotechnology to improve the delivery of Ayurvedic medicine was launched at the event. The product was developed inhouse by different departments at Amrita Institute of Medical Sciences and Amrita University’s School of Ayurveda. Other eminent medical experts attending the Conference included Dr Jeffrey White, Director of National Cancer Institute, US; Dr Daniel Furst, Rheumatologist at University of California; Dr Nereo Bresolin, Neurologist, University of Milan; Dr Christ-

ian Kessler, Internal Medicine Specialist, Charite Medical University, Germany; Dr Valdis Pirags, Diabetologist, University of Latvia; Dr Maryam Matar, Genetics Specialist, UAE; Dr Ravi Mehrotra, Director, National Institute for Cancer Prevention and Research, Noida; Dr BN Gangadhar, Director, NIMHANS, Bengaluru; Dr Rama Jayasundar, Professor, All India Institute of Medical Sciences, New Delhi, and Dr Ketaki Bapat, Scientific Advisor to the Government of India, among others. EP News Bureau

MARKET GROWTH TRACKER

IPM clocks ` 115,725 cr in June 2017 Dermatology continued to be the second fastest growing therapy area THE INDIAN Pharmaceutical Market (IPM) clocked ` 115,725 crores of which the retail sector was valued at ` 97,208 crores as of MAT June 2017 with a monthly value of ` 9215 crores with a growth of 0.3 per cent over the last year. The share of top 10 companies continued to be 43 per cent in the IPM and these top companies grew at just one per cent over SPLY. Out of the Top 10 companies only Mankind (11 per cent) and Lupin (nine per cent) recorded a positive growth for the month. The growth for companies in the 11-20 and 21-30 bracket was in negative for the month with these companies recording (-1 per cent) and (-3 per cent) growth respectively. Overall only nine of the top 30 companies showed a positive growth with MSD showing the highest growth at 12 per cent. The decline in growth of top companies as well as of whole IPM has been a result of GST implementation which was due on July 1, 2017. Though the longterm impact of GST on IPM remains positive, there has been some short-term disruption observed. 50 per cent-70 per cent of stockists/chemists weren’t clear and hadn’t initiated on implementation of GST in their businesses leading to inventory rationalisation by stockists due to which most pharma companies closed their sales for the month earlier than usual which had an impact on their overall sales. The impact can be seen of the Top 10 brands of IPM too where these brands which are valued at ` 306 crores have shown a combined single digit growth at 8 per cent over last year. However, Lantus (30 per cent), Janumet (16 per cent) and Spasmo-Proxyvon (19 per cent) continue to show strong growths while Mixtard and Glycomet-GP continues to maintain number one and number two positions and growths of eight per cent and five per cent respectively.

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August 16-31, 2017

TOP 40 BRANDS

Mixtard continues to be the top brand with a MS of 0.5% Betnovate-C, Lantus,Januvia and Duphaston have shown phenomenal growths in June 2017 ● Other brands with remarkable growth are Janumet, Spasmo-Proxyvon+, Synflorix, Dolonex, Istamet and Udiliv Source: QuintilesIMS TSA & SSA, June 2017 ● ●

ACUTE AND CHRONIC THERAPIES

Acute therapies continue to dominate the market constituting 65% of the IPM The top TC4 in the IPM is DPP4 Inhibitor and Combination with a value growth of 19% Source: QuintilesIMS TSA & SSA, June 2017 ● ●

MARKET Among top five brands, Lantus has displaced Janumet to take the third position. Also, within brands ranked between five and 10, Galvus Met has come down two places and is now ranked eighth as compared to its sixth rank in May. The impact has been more on brands ranked 1120 where seven brands recorded a negative growth with only Duphaston (26 per cent), Shelcal (7 per cent) and Synflorix (23 per cent) shown a progressive trend. Indian companies increased their share by one per cent as compared to May and now have a share of 79 per cent in the IPM and grew at par with the market at 0.4 per cent. Number one MNC Abbott (-0.1 per cent) recorded a slower than market growth where as other top 10 MNCs like Sanofi (five per cent), MSD (12 per cent) and Eli Lily (four per cent) showed a positive and better than market growth for the month. Overall MNCs recorded a growth of (-0.2 per cent). Chronic therapy grew at three per cent and registered a better growth as compared to acute therapy (0.5 per cent) which continues to dominate the IPM with 65 per cent share. Cardiac remains the largest therapy for the month of June with a growth of one per cent while anti-infectives jumped one rank above and displaced gastro intestinal to become the second largest therapy. Antidiabetic (10 per cent) showed the strongest growth among all therapy areas and was valued at ` 890 crores for the month. DPP IV Inhibitors and combination continued to be the number one therapeutic class 4 with a robust 19 per cent growth. However, many of the top 10 therapeutic class 4 like food supplements (-1 per cent), Amoxycillin and Clavulinic Acid Solids (-13 per cent) and conventional iron liquid (-3 per cent) recorded de-growth for the month. Cardiac therapy continues to be the number one therapy for the month with a revenue of ` 1102 crores and a growth rate of one per cent. Even though top combination molecules like Telmisartan+ HCT (six per cent), Amlodipine+ Telmisartan (11 per cent) and Metoprolol+ Telmisartan (17 per cent) have shown strong growths, the overall growth is

EXPRESS PHARMA

August 16-31, 2017

THERAPY TRENDS

Cardiac therapy and Anti Infectives constitute the largest market share in IPM occupying 12% share each Anti Diabetics and Vaccines registered a growth of around 10% and 9% respectively for the same period last year â&#x2014;? Vaccines and Oncology market have grown by 1% and 5% respectively, while rest of the therapies have de-grown over previous month Source: QuintilesIMS TSA & SSA, June 2017 â&#x2014;? â&#x2014;?

being pulled down by plain molecules like Atorvastatin (-20per cent), Telmisartan (-5per cent) and Metoprolol (-8per cent). However, few single molecules like Rosuvastatin (two per cent) and Cilnidipine (15 per cent) have shown progressive trend. This trend can also be seen where overall combinations in cardiac therapy have grown at six per cent as compared to plain molecules which have shown a growth of (-1per cent). Anti infective therapy area is valued at ` 1075 crores for the month of June and has regained its second position below cardiac after it lost the position to gastro intestinal in April. However, its growth continues to be slower than the market and has gone down for the month (-6 per cent) which is the lowest among top 10 therapy areas. Most of the top 10 molecules like Amoxycillin and Clavulinic Acid Solids (-13 per cent), Ceftriaxone Injectables (15 per cent) and Cefixime Oral Solids (-20 per cent) have shown a double digit negative growth with only Meropenam (12 per cent) and Ceftriaxone+Salbactum (28 per cent) showing a progressive growth trend. Gastro intestinal therapy area lost its second position which it had gained two months back to anti-infective. Gastro intestinal is valued at

` 1043 crores for the month with de-growth of -2 per cent. Even though its largest molecule Pantoprazole+Domperid clocked ` 63 crores for the month and showed a decent growth of 2 per cent, seven other molecules among top 10 recorded a negative growth to pull down the overall growth of the therapy. However, Bacillus Clausii continued its progressive trend and grew at 30 per cent for the month. Among brands, SpasmoProxyvon showed a robust growth of 19 per cent and continued to be the top brand in the therapy at both month and MAT level. Anti-diabetics maintained its fourth position in the IPM for the month of June 2017 and was the fastest growing therapy area with a growth of 10 per cent over SPLY. All top four brands in the IPM belong to this category and with robust growths. DPP4 Inhibitors continue to dominate with a 23 per cent contribution to the entire category while SGLT2 Inhibitor is the growth driver with a growth rate of 111 per cent for the month. Except for Metformin showing a negative growth (-11 per cent) and Glicalzide+Metformin showing a stagnant zero per cent growth, all other Top 10 molecules have grown strongly which has led to progress of the therapy. All of the top 10 brands except

Novomix (zero per cent) have shown robust growth with Lantus (30 per cent) and Januvia (30 per cent) leading the growth charts. Vitamins-Minerals-Nutrients (VMN) continues to be the fifth largest therapy area for the month but with a diminished growth of -1.3 per cent. This is mainly due to six of its top 10 molecules, which contribute around 40 per cent to the therapy, have de-grown at a combined rate of -4 per cent. Food supplements is the top segment within the therapy with a value of ` 136 crores and grew at -1 per cent. Becosules showed a growth of -2 per cent and continues to be the top brand in the therapy while the number two brand Shelcal grew robustly at 7 per cent for the month of June 2017. Revital-H (-33 per cent) showed the highest de-growth amongst top brands and moved down 2 ranks from fourth to sixth in the therapy. Dermatology continued to be the second fastest growing therapy area in IPM with a growth of eight per cent SPLY and a value of ` 669 crores for the month of June 2017. Emollients remains the largest sub category with a three per cent growth while the growth is driven by Itraconazole which continues to be the fastest growing molecule at robust growth rate of 96 per cent for the

month. Luliconazole, which was launched just last year, has continued its impressive performance by clocking ` 17.3 crores for the month. Among brands, even though the top brand Betadine showed a regressive growth of -4 per cent, other top 10 brands like Betnovate-C (41per cent), Betnovate-N (26 per cent), Panderm+ (35 per cent), Candiforce (85 per cent) and IT-Mac (146 per cent) ensured progressive growth for the therapy.

Global (May 2017) The global pharma market is valued at $1079 billion growing at 4.4 per cent. The US continues to dominate the market with 40 per cent market share with growth of 1.2 per cent. Amongst the top market, India remains at the same position and is ranked 11th. Only markets in the top markets with more than 10 per cent growth are Venezuela, India, Russia and Brazil. Except Germany, the remaining Top 5 EU markets are all de-growing as per May 2017 data. Indian companies hold 1.6 per cent share in the global market as per May 2017 data. For the month of May 2017, the IPM showed growth and all Top 10 companies showed growth. Top 10 companies contribute to 42 per cent market share in India.

MARKET POST EVENT

Indian Pharmacovigilance Day 2017 conference held in Hyderabad THE INDIAN Pharmacovigilance Day 2017 conference was recently held in Hyderabad. Dr J Vijay Venkatraman, MD and CEO, Oviya MedSafe was nominated as the Chair. The conference was sponsored by Oviya MedSafe and had Express Pharma, Life Science World and CIMS as its media partners. The conference started with a welcome address by Enrico Pedroni, MD, EasyB, Italy, followed by Dr Venkatraman’s address as the Chair to the delegates about the nature and purpose of the conference. Dr Ammar Raza S spoke about 'Changing Regulatory Market Landscape in Emerging Countries: Impact on Pharmacovigilance,' which was followed by Dr Arani Chatterjee, who gave a speech on 'Vaccine Vigilance – An Overview.' The next session was Higher Functions in Pharmacovigilance. Dr Nitu Sinha spoke on the topic 'Drug Safety in Biosimilars' followed by Dr Mamtha B Nair’s seamless presentation on the operational topic “PADER Vs PBRER – A Comparative Analysis of Aggregate Reports.’ The session ended with the speech by Dr Ankur Arora titled 'Safety Signal Detection: Do reporting Biases Matter in Today’s World?' The audience were given an overview of the future of pharmacovigilance by Dr Vivek Ahuja, who deliberated on 'Automation in ICSR processing – Is Artificial Intelligence the Paradigm Shift?' Dr SD Sinha spoke about 'Global Pharmacovigilance in Indian Multinational Pharmacovigilance Companies.' The colloquium titled 'Operational Excellence in Pharmacovigilance Outsourcing – Pros & Cons' was moderated by Dr Venkatraman, with the speakers being Dr PS Karthik Babu representing the pharma industry and Soumya Padhy representing the pharmacovigilance service provider industry. EP News Bureau

EXPRESS PHARMA

August 16-31, 2017

You are Invited! India BioForum - Next Generation Processing Trends in Biologics Tuesday 12th, September 2017 Hyderabad th Thursday 14 , September 2017 Pune Time: 9.00 am to 5.30 pm (Registration starts at 8.30 am)

Join us for “India Bioforum Next Generation Processing Trends in Biologics”. Experience a new outlook from our eminent speakers.

Topics: Trends and future prospects for process development of biopharmaceuticals Advances in the detection and prevention of viral and microbial contamination - regulatory expectations Future Upstream QbD High concentration UF and Formulation challenges

For registrations please contact manika.mehra@merckgroup.com Attendance to the “India BioForum - Next Generation Processing Trends in Biologics” is limited and by invitation only. The offer does not extend to any company that provides pharma or biopharma products or services. Merck reserves the right to revoke or refuse participation at any time. © 2017 Merck KGaA, Darmstadt, Germany. All rights reserved.

MARKET I N T E R V I E W

The nutraceutical space is innovation based and research driven Lasons India, a known name in APIs and leading manufacturers of Vitamin B3, have ventured into nutraceuticals through One Life. Gaurav Aggarwal, Director, Lasons India talks about this new venture, the growth opportunities in the field, the differentiators his company brings to the market and more, in conversation with Lakshmipriya Nair

You are a well-known name in bulk drug manufacturing for some decades now. How will the experience and learning in that area help in your new business? Our experience of more than three decades as bulk drug (API) manufacturers gives us the required technical experience to ensure quality, pricing and market understanding. We are one of the oldest and largest manufacturers of Vitamin B3 in the region. Our bulk drug customers are also customers of various other vitamins, minerals and extracts. As a result, we are well aware of and share a very healthy relationship with worldwide manufacturers of these ingredients. Most importantly, being manufacturers ourselves, we have a fully functional QC and QA department in house who is instrumental in audits, qualification of vendors at ingredients and formulation levels. As a consumer myself, I would personally prefer buying a product from a brand that has been in the industry for over three decades as compared to a new brand. It is very reassuring to the consumer. Why is it the time right to foray into nutraceuticals? How is growth in the nutraceuticals and wellness market in India gaining pace? What are the accelerators? The nutraceutical, dietary supplements, health foods

20 EXPRESS PHARMA August 16-31, 2017

industry is at a very nascent stage in India. There is a massive need for these products and it continues to grow rapidly. The Indian market for nutraceuticals is a very small part of the global market. Given the size and age and increase in awareness of our population, the market continues to grow steadily. This industry is largely innovation-based and it helps to have the experience we have. The youth of the country which is the majority population has become well aware of the needs and requirements of supplements due to the inability of the food in providing them the same. People in general are more health conscious and wish to live a healthier lifestyle. Supplements of various types provide the consumer the option of fulfilling the nutritional needs of the body regularly and in the correct dosages in most cases. Many of your clients, which include leading pharma companies, are also into nutraceuticals and wellness. Will your entry into this space give rise to conflict of interests? If not, kindly elaborate. Yes that is correct. Top10 companies across the globe from the pharma, nutra, cosmetic, food and feed nutrition industries are our clients. That being said, the traditional nutra products from India traditionally available continue with the same formulations over the

years. The nutraceutical space is highly research driven and there are new ingredients being tried and used regularly either alone or in formulations which have tremendous benefit. Further, our formulations are very different from that of our clients and hence there is no conflict of interest.

Experience, technical understanding, resources of a pharma company and the knowledge of more than three decades as a manufacturer of vitamins, are our key strengths

What are the differentiators that you bring to the market? How are you positioned to leverage the growth potential in this rapidly growing segment? Experience, technical understanding, resources of a pharma company and the knowledge of more than three decades as a manufacturer of vitamins, are our key strengths. We understand that the nutrition business is second to none. We follow strict standards at all levels to ensure stable quality supply of products. I believe this is our advantage and this helps the customer be assured of the products being consumed by them. You are metamorphosing from a pure B2B player to one with B2C interests as well. How does that change the rules of the game? India is one of the largest consumer markets in the world. We are in fact the largest young population in the world. If there is a market, we should be in for a B2C industry! Our factory is one the first factories to have received the

FSSAI certification upon its inception. Since last year, FSSAI has made many changes to the regulations and these are welcomed. With the growth of the industry there is also a need to regulate the same for the benefit of the consumer. Some studies available show that a large majority of the supplements available in the market are either unregulated or not authentic. This is not good for the consumer or the industry as a whole. It is important for the companies to keep a close understanding of the changing rules and itâ&#x20AC;&#x2122;s important to practice self governance. What are your growth strategies for the next three years (in terms of investment, market penetration and marketing)? We have identified our consumer base and will focus our efforts to reach them across the country. We wish to approach the consumer with as much information as possible about our products and the need for the same. I believe the consumer should be well informed about the need and the products for them to make an informed decision. In the coming time you will see our approach in this direction. We focus on offering the best quality and eventually customers will see the benefits of our products and this will certainly generate recall value. lakshmipriya.nair@expressindia.com

MARKET EVENT BRIEF 21

India Lab Expo 2017/ analytica Anacon India

Proactive & Sustainable Compliance Workshop

INDIA LAB EXPO 2017/ ANALYTICA ANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, Indiaâ&#x20AC;&#x2122;s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India. Contact details MMI India INIZIO 507 & 508, 5th Floor, Cardinal Gracias Road, Opp P&G building, Chakala, Andheri (E), Mumbai - 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 info@mmi-india.in

PROACTIVE & SUSTAINABLE COMPLIANCE WORKSHOP Date:December 7-8, 2017 Venue: Mumbai, India Summary Markets and Markets, will organise a seminar on Proactive & Sustainable Compliance Workshop. The seminar will have a panel of international experts who will shed light on recent compliance challenges confronting the biopharmaceutical industry worldwide with a special focus on the Indian industry. Contact details: Contact Person: Amit Shelke Email: amit.shelke@marketsandmar kets.com Contact Number: +91 20 30108 270

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22 EXPRESS PHARMA August 16-31, 2017

(

THE MAIN FOCUS

INSIGHT

24 ALEMBIC: A CENTURY AND STILL GOING STRONG

28 DOWN MEMORY LANE

30 A GROWTH SAGA As India celebrates its 71st Independence day, Express Pharma recalls some trials and triumphs which led to its rise as the ‘Pharmacy of the world’

32 PAGES FROM THE PAST

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Alembic: Acentury and still going strong Alembic Pharma has emerged as a renowned player in a thriving industry but not before tracing an eventful journey spanning over a century, that often mirrored the trials and triumphs of the country’s pharma sector. By USHA SHARMA

lembic Chemical Works Company Ltd was established in 1907, under the guidance and support of Maharaja Sayajirao Gaekwad as well as two geniuses of chemistry: Prof TK Gajjar and Prof Kotibhaskar. The founder, Rajmitra BD Amin and his friend SG Warty had left no stone unturned to ensure its existence, going to the extent of working as labourers for over an year, to set up the company. Pranav Amin, MD, Alembic reminisces, “The legacy of Alembic Pharmaceuticals Ltd (APL) dates back to over 100 years. Established in 1907 with an objective to develop and revolutionise the pharma and drug industry in the Indian subcontinent.” Since then, in over 100 years of existence, Alembic, one of India’s oldest pharma companies, has been a witness to several epochal events including two World Wars, India's birth as an independent nation, its struggles to hold its own in rapidly changing world, subsequent liberalisation and globalisation.

Alembic Research Centre

Setting benchmarks Alembic has crossed several milestones in the course of its journey. To highlight a few — In 1940, Alembic started manufacturing its well known cough syrup, vitamins, tonics and sulphur drugs. In 1952, the

24 EXPRESS PHARMA August 16-31, 2017

R&D labs: Then & Now

Analytical Development Laboratory

( company began its R&D activities. It became the first Indian pharma company to manufacture penicillin. In 1961, Lal Bahadur Shastri, the then Prime Minister inaugurated the penicillin plant at Vadodara. It 1971, Alembic manufactured erythromycin for the first time in India and in 1972, Althrocin, a brand of erythromycin was launched. In 2011, the pharma business demerged from Alembic and was listed as APL. Today, it is one of the leading pharma companies in India.

company caters to the rest of the world markets through branded formulation sales. Beside this, the company also adopted other ways to grow. In 2007, it moved on to acquire the non – oncology

business of Dabur Pharma, thereby gaining access to the lifestyle related therapeutic segments such as cardiovascular, diabetic, gastrointestinal and gynaecology. The company has strengthened its position in

THE MAIN FOCUS

the domestic market as well to grow exponentially in international generics. Pranav Amin informs, “We invested heavily in building world-class infrastructure and improved processes to match

the growing need. And also acquired international talent and became multi-cultural, diversified organisations. We grew rapidly over the two decades on the back of these investments in the international markets.”

Marching to its own pace The pharma industry was constantly evolving and buoyed by liberalisation, as well as laws which favoured indigenous companies, the domestic pharma industry was on a growth trajectory after the 1970s. The Indian pharma companies, after establishing a strong base in the domestic market, started looking at international markets to grow. Further, these companies also started investing in building a presence in the US by filing ANDAs. However, Alembic took its time venturing into the overseas markets to understand international regulations, gain insights on market requirements, intellectual property to enable early launches etc. However, after it chose to go the international route, it has tried to accelerate its growth trajectory. In 2006, Alembic received its first ever US FDA approvals for its API and formulation plants. Since then, the company has had several successful ANDA and DMF filings in the international generics market. It has set up its US office where sales and marketing is done on the Alembic label for the US market. Now, it is keeping pace with other players through heavy investments in building manufacturing facilities and developing a wide portfolio of products to tap international markets, with a particular focus on the US. APL has also filed across Canada, Europe, Australia, South Africa and Brazil. The

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*All major components

Pharmalab India Private Ltd., Registered Office: Kasturi, 3rd, floor, Sanghavi Estate, Govandi Station Rd, Govandi (E), Mumbai 400 088, INDIA. • E-mail: pharmalab@pharmalab.com • Website: www.pharmalab.com CIN No. U29297MH2006PTC163141.

cover ) SOME OF THE DRIVING FORCES BEHIND ALEMBIC’S INCEPTION AND GROWTH

L-R: Maharaja Sayajirao Gaekwar, Prof AS Kotibhasker, Prof TK Gajjar, Rajmitra BD Amin and Chirayu R Amin

RB Amin with Prime Minister Jawaharlal Nehru

He further explains, “In order to recover on lost time, Alembic’s strategy has been to partner with different players to ramp-up rapidly. We are also focussed on developing new skill sets internally in various new areas and continue to look for opportunities to grow our business.” When asked about ongoing/future acquisitions, he says, “Acquisition is quite expensive in the pharma domain so we have signed up a few joint ventures. We have formed a joint venture of 60:40 with Orbicular called Aleor Dermaceu-

ticals to develop dermatology products for international markets. We have also formed a JV in Algeria named Alembic MAMI SPA to explore the African market.”

Backed by science Of the several significant contributions of the company, the most notable was the scientific temperament it introduced in a country which was largely dependent on home-grown/ based remedies at the time of its inception. Keeping in line with its legacy, the present manage-

ment of Alembic hires MRs majorly from scientific backgrounds. Today, the company has over 5000 medical representatives and field managers and intends to keep increasing it. Pranav Amin informs, “Our approach of the sales force is totally scientifically oriented. Every month approximately 300 medical sales representatives (existing and new) from across India receives training at our Baroda facility.” Explaining the nature of the training process, he says, “Our field-force is put through rigorous basic training,

MAJOR MILESTONES 1907

Started manufacturing tinctures and alcohol at Vadodara

2009

Addressed chronic therapies through multiple marketing divisions

1940

Started manufacturing cough syrups, vitamins, tonics and sulphur drugs

2010

ANDAs total filed 38, DMFs total filed 53 and got approval of 15

1961

The penicillin plant was inaugurated by Lal Bahadur Shastri

2011

Pharmaceutical business demerged from Alembic – APL Listed

1967

Bulk manufacturing of Vitamin B12 began

2012

Launched dermatology division in domestic market with 8 products

1971

Erythromycin manufactured for the first time in India

2013

Launched first NDA with a partner. Commenced filing in EU,Australia and Brazil

1972

Althrocin a brand of Erythromycin launched

2014

Formed a JV in Algeria- Alembic MAMI SPA to explore African market

1997

Althrocin becomes top selling brand in India

2015

1999

Alembic starts production of synthetic organic API

Launched Aripiprazole on Day-1. Established the US front-end, transition to own marketing in the US

2000

Gets ISO 14000 Certification for facilities at Vadodara

2016

2001

Starts manufacturing Cephalosporin C

Formed JV 60:40 with Orbicular – ‘Aleor Dermaceuitical Limited’for developing dermatology products for international markets

2007

Acquisition of non-oncology Business of M/s Dabur Pharma Ltd.

2017

The anti-cancer drug manufacturing plant was inaugurated by Vijaybhai Rupani

26 EXPRESS PHARMA August 16-31, 2017

(

THE MAIN FOCUS

tinues, â&#x20AC;&#x153;The duly enabled and empowered Alembic MRs are the true ambassadors of the organisation and this in itself is the USP of Alembic in the domestic market.â&#x20AC;?

cluding formulation research, and a 150-bed bio-equivalence facility at Vadodara. Additionally, APL has recently invested in an ultra-modern R&D center at Hyderabad. The company invests 14 per cent of its turnover in R&D. Recently, Alembic also commissioned a state-of-the art anti-cancer manufacturing facility at Panelav, Halol, inaugurated by the Chief Minister of Gujarat, Vijaybhai Rupani. Thus, the company growth story reflects the rise of the pharma industry into a global player. Armed with experience and expertise, the company is set to conquer new heights in times to come.

Growth strategies

Lal Bahadur Shastri visiting the Alembic facility

refresher programmes and a variety of managerial skill development workshops. Resul-

tantly, the field-force is proficient with pharmacology knowledge, medical knowl-

edge, product knowledge and are also updated with various marketing strategies.â&#x20AC;? He con-

Alembic has grown manifold ever since its inception. Its existence and dominance in the pharma market in the country is an evidence of the fact. Today, as a listed entity, Alembic manufactures and markets generic pharma products across the globe. With an emphasis on innovation and technology, the company has established a state-of-the-art research facility â&#x20AC;&#x201D; Alembic Research Centre (ARC) â&#x20AC;&#x201D; in-

u.sharma@expressindia.com

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cover

)

DOWN MEMORYLANE

At IDMA meeting with Dr Samuel Paul, Director IIM, Ahmedabad at Taj Intercontinental on May 3, 1973 Image courtesy: IDMA

RB Amin with Prime Minister Jawaharlal Nehru

Meeting with Prof Adarkar of Reserve Bank of India under the auspices of IDMA in Hotel Nataraj on November 10, 1969 Image courtesy: IDMA

PM Lal Bahadur Shastri inaugurates penicillin production

IDMA meeting with Minister of Health, Mr Patil, flanked by President of Yemen on the right and Dr Yusuf Hamid of Cipla on the left Image courtesy: IDMA

Glimpses of the antibiotic manufacturing process

28 EXPRESS PHARMA August 16-31, 2017

Image courtesy: Alembic Pharmaceuticals

(

Pharma lab in the yesteryears

Image courtesy: Cipla archives

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A researcher at work

Image courtesy: Cipla archives

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Agrowth saga Ajit Singh, Chairman, ACG Worldwide, speaks on the journey traversed by the Indian pharma industry and predicts a bright future for it in the times to come

he amazing growth, sophistication and international reach of the Indian pharma industry in the last few decades has few parallels. It is now promoted as the ‘Pharmacy to the World’. I prefer to use the words ‘World’s Pharma Hub’ which would be more correct, also in its grammar. Our group, ACG Worldwide (formerly, the Associated Capsules Group), started its production of empty capsules in the 1960s, along many of the present leading companies of the Indian pharma industry. We grew side-by-side with the Indian pharma industry. Let me illustrate the performance of this industry based on ACG’s actual experience as a leading supplier of equipment and consumables. By the second year of our production by when the output had reasonably stabilised, we were producing about 50 million capsules per year. We are now producing about a 100 billion capsules a year. This exponential growth is an indication of the growth of the pharma industry in India. As the World’s Pharma Hub, India makes thousands of formulations to meet all illnesses and doctors’ prescriptions. Some people say that, in spite of its other advancements, India has been largely unable to develop any new pharma molecules that have become blockbusters. This may be so, but should India’s strategy be any different from what it is. The Government of India has played a strong supportive role even as it burdened the industry with a number of controls. For example, in an almost uncanny fashion it gave protec-

30 EXPRESS PHARMA August 16-31, 2017

ACG's factory at Shirwal, near Pune - One of India's largest factory making pharma machinery parts

tion to the industry when it was most needed. And left them to compete with the rest of the world at the appropriate time, when it was felt to be strong enough. Pharmexcil, the export promotion council has also played an important role in assisting the globalisation of this industry, particularly in the last few years. India has developed the capacity to manufacture huge quantities of formulations, of world quality standard, at the

world’s cheapest prices and it still makes a profit. This is itself an indication of high technology and competence, surely more important than inventing a couple of new molecules. No other country in the world has been able to match this performance, and India’s leadership increases year-by-year. Though the IT industry has received greater recognition and its size is much bigger, the pharma industry should really be recognised as the pride

of India. It’s a high-tech, high value-added industry not relying on cheap labour, and operating with ingenuity and high productivity. Due to its affordable prices, the industry saves millions of lives globally each year. One of the noteworthy aspects of the Indian pharma industry is that many of the largest companies in India are headed by pharmacists or technocrats. This is not so in advanced countries where large

companies are generally headed with persons from Finance or Marketing or similar backgrounds. The resilience of this industry in India is demonstrated by its success and growth even though it has the strictest price controls in the world. Like a champion weight-lifter challenged with heavier and heavier weights, every successive round of price control the industry has not succumbed, but has only strengthened. And, interestingly, several heads of pharma companies are among the richest in the country. Alongside, Indian pharma, its ancillary industry has also developed the capabilities, the technology and competence to compete globally. For example, in the sophisticated, high technology gelatin capsule industry, ACG is the second largest in the world and growing much faster than others. Several types of pharma machines designed and made in India lead the world in volume of production and in the value-for-money they offer to pharma customers worldwide. Major global pharma producers and even MNCs, recognising the strong competition they face from Indian pharma manufacturers, have started importing and using Indian-made machinery and ancillaries, as historically done by Indian competitors, so that their costs become more competitive. At the present time, various units of the Indian pharma industry are facing rough weather with inspection of their plants by some overseas FDA agencies. Somewhat damaging is the focussed attention such

( supposed shortcomings get in the global media. If one looks at the websites of some of the overseas FDAs, the strictures on the pharma companies in their own countries are equally onerous, often to the extent of recalls of pharma products. However, they do not receive the same publicity. In my opinion, this situation will not last for long. The indian pharma industry is rapidly complying with the requirements of overseas inspection agencies. The issue largely concerns to documentation and accuracy of recordings. Retraining, and an attitude of compliance needs increased focus all the way down the line. And the lower you go, the more difficult and time consuming it can become. Perhaps a quicker solution would be to install more automation. This is also necessary for further advancements in the pharma industry. Where Indian exports to advanced countries have been temporarily affected, those countries will have to obtain their medicines from elsewhere, or manufacture locally. The costs will be much higher, with a drain on their national budgets, as prices of most medicines in many countries are borne by the governments themselves. As it is the cost of the medicines for their employees is so high that, in industries such as the automobile industry, the cost of medicines for their employees is higher than the cost of steel they purchase. It is likely that for the supply of medicines, the advanced countries will soon have to revert to India The Indian pharma industry, however, should not rest on it’s past success. Other countries such as China who dominate the world’s supply of bulk drugs, are anxious to replace India as the global supplier of formulations. The Indian pharma industry should respond, and it is responding, by getting into more sophisticated formulations and dosage forms, as for example, by producing and exporting ‘super generics’. These have

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vast potential and superior margins. With its large reserves of well-trained pharmacists and technocrats, many of which migrate into the pharma industry,

India is in a unique position to move up the value chain. To accelerate this process many leading pharma companies are working closely with their suppliers of equipment

THE MAIN FOCUS

and consumables like capsules. As an observer of the world pharma industry for decades. I am very hopeful for the future. We need to salute the leaders, the professionals and

the workmen of Indian pharma industry for planting the flag of India through exports to over a hundred countries. And much of the world market is still available.

cover )

OPPORTUNITIES CALLING The scenario which existed 20 years back has gained more relevance in the current times.The possibility of tapping new patient segments, creating branding strategies around innovative drug delivery approaches and meeting evolving regulations. Be it in the discovery and development of new, better medicines or improving existing ones, there is clearly a need for the knowledge of executable strategies and leading-edge technologies in drug delivery today as well.

32 EXPRESS PHARMA August 16-31, 2017

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THE MAIN FOCUS

MASTERING THE 3CS In another interesting article from the Independence Day special issue of Express Pharma, published in the year 1997, the author predicts that 3Cs â&#x20AC;&#x201D; Customers, Competition and Change will always be the driving factors in the pharma industry. He also outlines the strategy to survive and thrive in a rapidly changing environment. His philosophy and advice has withstood the test of time and is relevant even in the current scenario.

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cover )

A CHANGING PANORAMA The pharma sector has evolved tremendously from from the time we gained our independence to the present day power house that produces and supplies high quality generic drugs to markets across the world, in driving the progress of the nation. An article from our archives which predicts how the industry dynamics would change in the years to come. India Pharma Inc adopted several of the measures outlined in the article and have achieved considerable success in the past 20 years.

34 EXPRESS PHARMA August 16-31, 2017

MANAGEMENT

Veg meds: Yay or nay? vs he debate over gelatin capsules vs plant-based capsules (Cellulose) has garnered a lot of attention from all stakeholders of the lifesciences industry. The discussion began almost a year back when Maneka Gandhi, Union Minister for Women and Child Development made a ‘representation' to the Health Ministry on completely replacing gelatin capsules with plant-based capsules following a request received from the Jain community to create an option so that consumers can not be forced to use capsules made from animal tissues. JP Nadda, Union Minister of Health and Family Welfare discussed the matter with the Drug Controller General of India (DCG(I)), Dr GN Singh and and then Health Secretary, Bhanu Pratap Sharma to look into the matter on a priority basis. However, the matter wasn’t taken up at the Drug Technical Advisory Board (DTAB) and failed at the initial proposal itself. However, lately the debate has regained steam and now an expert committee set up by the Health Ministry has asked all stakeholders to share their views on the matter. However, it is an issue with wide-ranging implications. Some of the major questions that the situation throws up include: ◗ Gelatin-based capsules have been in use for over 185 years. How easy and feasible would it be to replace them? ◗ Is the issue about benefits or are we tinkering with long-established, scientifically-proven practices to pander to religious sentiments? ◗ Cellulose-based capsules are likely to be more expensive. Is it morally right to make medicines more expensive in a country struggling to ensure healthcare access? ◗ What are the proven benefits, if we switch over from gelatin-based capsules to cellulose-based capsules? ◗ How will the industry be affected by the switchover, if cellulose-based capsules become the new reality? Industry leaders and veterans share their views on these issues and highlight the different aspects of such a switchover.

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MANAGEMENT

QUESTION POSED TO MOHFW IN THE LOK SABHA Unstarred question no: 2081, Answered on: 28.07.2017, Jayadev Galla-TDP-Teleana

Will the Minister of Health and Family Minister be pleased to state: (a) whether the types of cellulose capsules that are presently available in the market are different from animal based gelatin capsules, if so, the details thereof; (b) whether switching over to vegetarian cellulose capsules will hit the Rs 5000 crores gelatin capsule industry; (c) if so, the details thereof; and (d) the action taken by the Government to address the problem? Answered by Faggan Singh Kulaste, the Minister of State in MoH&FW (a): Yes. Presently, cellulose capsules are prepared from HydroxyPropylMethyl Cellulose (HPMC), which is synthetic in origin, whereas Gelatin Capsules are pre-

pared from gelatin which is a purified protein obtained by partial hydrolysis of animal collagen (b) to (d): The Government has not received any such report that switching over to vegetarian cellulose capsules will hit the ` 5000 crore gelatin capsules industry. However, some industry associations have raised certain issues including technical issues and economic viability for replacing gelatin capsules with cellulose capsules. The government has, after examination of all pertinent issues relating to use of gelatin capsules and its replacement by cellulose based capsules, already constituted a Committee to consider all pertinent issues and make recommendations to the Government.

'CONSUMPTION OF MEDICINE IS MORE CURATIVE THAN OUT OF PERSONAL CHOICE'

36 EXPRESS PHARMA August 16-31, 2017

Secretary-General, IDMA

e have taken up the matter with the Health Ministry and DCGI. We also had a meeting with Nripendra Misra, Principal Secretary to PMO on July 18, 2017 in New Delhi and explained to him that change over from gelatin capsules to cellulose capsules in no way would benefit our Indian population. He asked us as to how much time industry would require to change over, to which we put forth our logical arguments as mentioned below. Finally, he was of the opinion that both types of capsules should co-exist. We therefore request the government to continue to allow the use of gelatin capsules to ensure availability of safe, efficacious and affordable drugs to the patients.

◗ Gelatin capsules have been in use for over 100 years. It has been found to be very safe for human consumption and accordingly it has been accepted by regulators all over the world.

◗ There have been no adverse reports of gelatin capsules. ◗ We are totally self-sufficient with the raw materials for gelatin capsules.

Director, PHD House

elatin capsules are consumed by people at large as carriers of important medicines used to cure many terminal and lifestyle diseases. The consumption of medicine is more curative than out of personal choice. Looking at fundamentals, it is not prudent to enter the vegetarian and non-vegetarian debate in this matter. It may further be noted, that gelatin used in the manufacture of empty capsules are derived from an extraction process wherein no animals are harmed or killed for this specific purpose. Only the leftover bones having hydroxide and collagen, which is a protein widely found in animal bones (and is not more than two per cent of the total value of the dead animal) is extracted through sophisticated machineries in a WHO-GMP approved extraction and manufacturing plants. Accordingly it is misplaced to have any notion that gelatin capsules are non-vegetarian in origin. The Supreme Court, in its order dated March 07, 2013, Case No. 641, had ordered that there is no need for non-veg or veg labels on drugs or

DAARA B. PATEL

◗ Thousands of crores have been spent on establishing the quality, viability and economics of gelatin capsules.

VIVEK SEIGELL

'IDMAWOULD NOT RECOMMEND CHANGE FROM GELATIN TO CELLULOSE'

cosmetics and hence even the red dots which are printed on non-veg products was not implemented for medicines. In the meanwhile, soft gelatin capsules have been given a go-ahead, therefore there is no prima facie issue with the raw material and hence the replacement of hard gelatin capsules because it is non-vegetarian is totally misplaced and uncalled for. Across the globe, over 95 per cent of capsule formulations are gelatin capsules and even among the rest five per cent, Hydroxypropylmethyl cellulose (HPMC) is primarily used for nutraceutical formulations. In India, only around two per cent capsules are HPMC-based and almost all of them are neutraceuticals. No cellulose capsules are used for products such as antibiotics, oncology, anti-infectious, painkiller and other medicinal categories. Nor have any tests been carried out by the DCGI in India whether such medicinal products would retain their stability, bio-availability, bio-equivalence and other properties if filled in cellulose capsules.

◗ We will be totally dependent on imports of raw materials for cellulose capsules. ◗ The safety and efficacy of cellulose capsules cannot be guaranteed. Members are concerned that even after approvals, few long term studies may show adverse reports and they may not want to take the responsibility for that. ◗ Today we manufacture 120 billion gelatin capsules compared to only two billion cellulose capsules. ◗ Cellulose capsules are two to three times expensive compared to gelatin capsules.This would increase the cost of drugs to the patients. ◗ Huge investment in plant and machinery would be required to adopt cellulose capsules. ◗ Several newspaper reports are harming the Industry’s reputation and needs to be countered.

MANAGEMENT

'WE SHOULD NOT BRING RELIGIOUS SENTIMENTS INTO MEDICATION AND HEALTH NEEDS OF PATIENTS'

atients have the right to choice based on credible information . I recollect when we were debating on vegetarian and non-vegetarian labelling of food products derived from non-vegetarian ingredients in the food to enable consumers to make an informed choice. Even during those days in 2003-4 the issue on medicines was raised but the policy makers made sure that we do not confuse the consumers on such issues which concerns their health and medication to treat disease. Now again we find commercial considerations and profit motives are over-riding the need for health and safety of consumers by debating on gelatin capsules vs cellulose capsules. Consumers do have the right to choice but we should be careful while communicating the message as it should never mislead the consumers on quality and safety. All these years, scientists always promoted gelatin-based capsules and never tried to differentiate between gelatin and cellulose capsules to ensure we do not compromise on accessibility and did not bring religious sentiments into medication and health needs of patients. Why this sudden debate in public domain, especially in a country where citizens are denied treatment due to high out of pocket expenditure on medicines. This is certainly not an appropriate time for India to further confuse the Indian consumers who are already struggling to access safe and quality healthcare by differentiating between gelatin and cellulose aapsules. We should close this debate right away and enable consumers to access medicines in the most scientific manner rather than raising concerns which are not in the interest of Indian patients.

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August 16-31, 2017

BEJON KUMAR MISRA Founder, Consumer Online Foundation

MANAGEMENT

‘IT IS NECESSARY TO RELOOK THE ISSUE OFVEG V/S NON-VEG CAPSULES W.R.T.TECHNICAL, REGULATORY & ECONOMIC ASPECTS’ DR MALA D MENON Professor of Pharmaceutics, Bombay College of Pharmacy

he whole issue of animal vs vegetable origin capsules needs to be looked at objectively.

Technical issues A major limitation with gelatin capsules is moisture sensitivity; second drawback is cross linking in presence of aldehyde compounds, resulting in variations in DT and dissolution profiles. HPMC capsules, on the other hand have a much lower moisture content (almost one-third) compared to the gelatin shell, making it compatible with hygroscopic materials, and providing better stability under a wide range of environmental conditions. In case of HPMC capsules, there are two major limitations. First is the low correlation between in-vitro dissolution/disintegration and in vivo performance, in comparison to gelatin capsules, attributed to interaction between in-vitro testing media (especially potassium ions and temperature) and HPMC capsule gelling systems. Thus, developing an in-vitro dissolution tests for HPMC capsules is more challenging. Another issue is that machine ability of HPMC capsules differs from hard gelatin capsules; modifica-

tions in processing and the need for gelling systems is important to get proper capsules of desired specifications and avoid higher rejection when used in filling machines.

Regulatory issues Monographs and regulatory guidelines for HPMC capsules are still under review and consideration. Reformulating the existing gelatin capsule products to HPMC capsules will entail a rigorous exercise of change control with regulatory impact with a battery of evaluations - compatibility studies with HPMC capsule material, physicochemical characterisation, including in-vitro release studies; stability assessment; package suitability; scale up batches etc. and in certain cases repeat of high cost bio-equivalence studies. This would then be followed by variation filing with regulatory agencies requiring prior approval.

Economic issues HPMC capsules are three to four times more expensive

compared to gelatin capsules. The change control protocol and testing for regulatory approval will involve an economic burden. The current installed capacity for HPMC capsules is very marginal, only around two per cent compared to gelatin capsule manufacturing capacity. Thus, there is a very big gap to be filled to completely replace gelatin capsules, again a highly cost-intensive issue. In conclusion, it is necessary to relook the issue of veg v/s non-veg capsules w.r.t. technical, regulatory and economic aspects and not be swayed by religious sentiments. In a developing country, delivering cost-effective medication is of utmost importance. Time tested gelatin capsules need to stay. HPMC capsules can be an option for new products under development; they are more advantageous for inhalation products where the inhalable fraction is better with HPMC capsules, and for drugs having compatibility problems with gelatin. More regulatory guidelines are awaited for HPMC capsules to expand their usage in future; further improvements needed in HPMC capsules to increase their utility are machinability and better correlations in IVIVC.

THE DEBATE IS NOTABOUTBENEFITS BUTRELIGIOUS SENTIMENTS RATNA DEVI CEO DakshamA Health, Founder Indian Alliance of Patient Groups (IAPG)

aving just barely grappled with generic drugs, price capping and yoga, patients now have a new dilemma - ‘Should I ask my physician whether the capsules he prescribes are gelatin or cellulose?’ For most patients in India who were unaware of the coating around their capsules, this is a new and interesting debate. The dialogue is not about which is more beneficial and cheaper but of one which revolves around vegetarian vs non – vegetarian and apparent religious sentiments attached to it. Gelatin capsules are cost-effective but are not stable when exposed to heat or humidity and could present serious storage problems with the capsules. Gelatin capsules are appropriate when using powdered supplements, but would not be advisable when using a liquid or gel format. On the other hand, the vegetarian capsule is created using cellulose, which is naturally derived from plants. The vegetarian capsules provide a very natural delivery system for the supplement ingredients and still

38 EXPRESS PHARMA August 16-31, 2017

allow the rapid delivery of the contents to the body. Vegetarian capsules has no threat of negative health risks, even when consumed in higher volumes and over the long term. Globally, gelatin capsules have been time-tested and are held to be safe and are recognised by regulatory agencies across the globe. That over 95 per cent of all capsules in world are gelatin ones is strong evidence supporting these. Gelatin capsules have been used for many years and pharma companies with presence in markets across the globe have their compounds delivered in gelatin capsules. As compared to gelatin capsules, the number of cellulose capsules that have been approved is significantly less. Switching over to 'pure-veg' capsules will lead to an increase in the cost of associated medicines, according to experts apart from the change in technology and sourcing of raw materials that would require time and planning. The Health Ministry is looking to replace gelatin capsules with cellulose-based ones and has set up an expert

committee to look into the matter. It has invited all stakeholders to send their suggestions and comments. The patients do not have a very big voice but would definitely like the medicines to be within their reach and as long as the price of medicines is not affected or there are no supply disruptions, the coating hardly mattered. ie until now. This debate ignites questions in many people’s minds. The seemingly innocuous capsule has assumed a religious colour and there are strong sentiments that the origin and use of animal products without appropriate warnings leads to cheating and duping and playing with the emotions of people. The government’s decision will therefore find popular acceptance amongst the patients and their families. It remains to be seen however, as to how the price will be kept in check and the transition managed. Until then, the religiouslyconscious patient will continue to pop in the gelatin capsule and have office and neighbourhood debates based on religious and political affiliations.

MANAGEMENT

DISCONTINUING ONLY HARD GELATIN CAPSULES WILL BE AN OUTRIGHT NON-TENABLE DISCRIMINATION AJIT SINGH Chairman, ACG Associated Capsules

The Ministry of Health and Family Welfare (MoH&FW) has set up an expert committee inviting suggestions from stakeholders about the possibility of replacing hard gelatin capsules with cellulose-based capsules. The government feels that hydroxypropylmethyl cellulose (HPMC) capsules may be safer than hard gelatin capsules. This is an unwarranted concern as hard gelatin capsules are thoroughly tested by MoH&FW and experts have been able to produce a monograph on the product in Indian Pharmacopoeia, as exists in several International Pharmacopoeias. Their specification guarantees the safety of the product for human consumption. Stakeholders are of the opinion that despite several requests, there has been no explanation from the gov-

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ernment on any scientific reason why this matter has been raised. Hard gelatin capsules have been used around the world for over a 100 years, with no untoward health consequences reported. On the other hand, HPMC capsules are hardly used at all as an edible container for medicines. Almost all of it is used for nutraceutical products. Therefore there is no history nor evidence of the continued potency of a drug after packing in HPMC capsules. Trials need to be conducted on disintegration, dissolution, stability, potency and bio-equivalence over the complete shelf life of each formulation. There are thousands of such formulations. If adverse reaction between HPMC capsule shell and varied ingredients of the formulation exist, there may be chances of discolouration, or loss or gain of moisture, or loss of po-

tency of the medicine. For life saving medicines, this is a risk as the pharma industry is not likely to be held responsible for, whatever may be the final decision of the expert committee. There is a feeling in some quarters that this matter has surfaced due to vegetarian sentiment. The Drugs Technical Advisory Board (DTAB) in one of its earlier meetings had minuted that drugs are prescribed by doctors to save lives and marking them as vegetarian or non-vegetarian origin is not desirable. An earlier Supreme Court ruling has also concluded that it is not desirable to label life saving drugs as of vegetarian or non-vegetarian origin and it should be left to medical practitioners to decide what is appropriate for a patient.

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MANAGEMENT

‘GELATIN-BASED CAPSULES HAVE PASSED THE TEST OFTIME’ ISHAN KHAITAN President, Operations and Marketing, Sunil Healthcare

edicine is administered to living beings for preventive and curative purposes. It is almost never consumed as 'food'. Accordingly, the proposition to bracket medicine with food is misplaced, which may have severe ramifications and dire consequences. This has also been acknowledged several times by the DTAB, the technical committee housed in the Health Ministry. Additionally, even the Supreme Court of India, has ruled favourably for this cause. The primary and foremost objective of the healthcare industry is to safeguard and promote healthy living. Availability and accessibility of safe, pure and effective medicines are prerequisites and enablers to help meet this mission statement. Under no circumstances can science be mistaken for or compromised for any kind of sentiment. The idea of ‘replacing’ gelatin capsules with HPMC

has no scientific backing. Gelatin capsules have been used across the world for administering the requisite dosage forms for over 140 years without any adverse reports on life due to consumption of these capsules in either of the dosage forms – hard or soft. Its specifications are well documented across all pharmacopoeias of the world. The long lineage of the gelatin capsules is a testimony their safety, purity and efficacy. This is further enforced through regulatory specifications of its monographs which are duly scrutinised and adopted by all food and health authorities across the world. Gelatin-based capsules form close to 99 per cent of the total capsule dosage which is available across the world. This vast usage serves as a stamp of acceptance by the pharma and nutraceutical majors who readily use this carrier to encapsulate a wide range of formulations for a plethora of curative and preventive reasons. The gelatin based capsules have not only passed the

test of time, but have also been widely tested and researched on for their stability, dissolution and disintegration profiles under various conditions and for a varied set of formulations. The pharmacokinetics and pharmacodynamics are well documented for gelatin capsule formulations. We cannot, under any circumstance, put these tests to question for any reason other than those which have a scientific merit to them. Furthermore, HPMC capsules are anyways available today, albeit in an extremely small quantity. The user has a choice even today. Given this, where is the case for thinking about any replacement? Any such deliberation is fraught with the risk of uncertainty as there is no scientific testing or data to establish the regulatory compliance of HPMC material as a carrier either today or over an extended period of time. Without proven data, tinkering with well-established drug delivery systems is an idea best left unchartered.

THE SWITCHOVER SHOULD NOT BE TAKEN AS A KNEE JERK REACTION SR VAIDYA Director, BlissGVS Pharma

hese are some of the merits and demerits of both gelatin and vegetarian capsules. Although the scale might tilt towards vegetarian capsules in a certain way, one cannot lose sight of the track record and the safety profile exhibited by gelatin capsules over years (more than five decades). The switchover should not be taken as a knee jerk reaction and should be done gradually as this might pose some situations which are not palatable. For instance: 1. Entire documentation procedure in the dossiers and data systems have to be withdrawn and rectified possibly, which is a colossal job. 2. Could bring in an economic collapse on the existing manufacturers which has served the society for decades across the globe. Should this happen?.. 3. Various modifications and advances adapted in the present gelatin capsule could be frittered away without any consideration. They were all patient friendly advances in terms of disintegration and dissolution. 4. Is it really a problem of acceptance? Or is it a case vested interests that loom over the debate?

40 EXPRESS PHARMA August 16-31, 2017

◗ Gelatine-based capsules are an inexpensive option ◗ Stability proved over a long periods of time ◗ Depends on the content to be filled as they have been proved beyond doubt over the years in terms of stability. ◗ Made up of animal origin and could be the main reason for the opposition as vegetarians would rather prefer the nonanimal source. ◗ Gelatin is not very suitable for sensitive drugs. ◗ Dissolution profile in gelatin could be disturbed and thus total stability is questionable in some cases. ◗ Tensile strength of gelatin capsule are higher. ◗ Gelatin enables to control manufacturing losses.There is a typical pungent odour on keeping in containers ◗ Time tested filling and integrity proved over a period of time even with pellets and other material. ◗ Could prove to be allergic to some patients.

My recommendation is that both should be accepted by manufacturers and the option should be left to the manufacturer and consumers as per merits. Moreoever, a slower transition with reasonable timelines should be allowed for a switch over.

◗ Cellulose-based capsules are expensive to manufacture ◗ Stabilityis yet to be tested beyond satisfaction as it is relatively a new introduction. ◗ Contents other than powder can be filled in HPMC capsules as they are not compatible with gelatin. ◗Wide acceptance among vegetarians and non-vegetarians ◗There is no bovine or porcine sources which create sectarian problems among certain non-vegetarian communities ◗ HPMLC capsules are acceptable for longer periods of storage in a country like ours,as humidity is a predominant factor. ◗ Distribution profile is clear and the product may not get disturbed in terms of long term stability. ◗Tensile strength of vegetarian capsules are lower ◗ Manufacturing losses could be higher ◗ No pungent odour in these capsules as they are odourless , tasteless and completely biodegradable ◗Vegetarian capsules are brittle and with low moisture content, hence manufacturers could incure high losses ◗ May not be suitable in all the products ◗ One really does not know the established long standing consistency in the case of machinability in comparison to the ease of machinability of gelatin ◗Totally free of allergic reaction.

MANAGEMENT REPORTS

AML market to surpass $1.5 bn by 2026 Major drivers of the AML market will include the launch of premium-priced therapies, an increasing branded drug treatment rate etc THE HUMAN epidermal growth factor receptor type II (HER2)-positive breast cancer space across the eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and China, which is set to hit $9.89 billion in 2025, is likely to face barriers due to the introduction of new biosimilars, according to GlobalData. The company’s latest report states that the long-anticipated launch of oncology biosimilars in 2017 will be closely watched as drug makers expect to struggle with biosimilar erosion of their own biologics. In the HER-2-positive breast cancer market, the EU and Japan patents protecting Herceptin expired in 2014, meaning that biosimilar trastuzumab can enter the marketplace, while the drug’s patent in the US will not expire until 2019. Maxime Bourgognon, Senior Healthcare Analyst, GlobalData explains, “Trastuzumab biosimilars are now under review with the EMA and FDA, and the first biosimilar was filed for approval in Japan in April 2017. Considering the generally high uptake of biosimilars in the European markets, the launch of trastuzumab biosimilars is expected to have a significant effect on the market landscape. “While physicians across all markets remain cautious when extrapolating clinical bioequivalence data, payers are expected to support switching to the cheaper alternative. Despite the growing portfolio of other HER2-targeted agents, this could be the first significant challenge to Roche’s stronghold on the market.” However, GlobalData believes the impact that trastuzumab biosimilars will have on the HER2-positive breast cancer space could be limited in markets where subcutaneous Herceptin was already sold at a cheaper price to its intravenous counterpart. EP News Bureau

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MANAGEMENT

Nephrology and urology devices market growth predictions drive $57 billion investment Asia-Pacific leads the market with a 43 per cent share, followed by North America and Europe THE LATEST report on the nephrology and urology devices market from GlobalData, has highlighted how an explosion in diabetes and hypertension combined with aging populations is driving investment to meet patient needs. Leading companies in this field, principally from Europe and North America, have invested over $42 billion in mergers and acquisitions and nearly $15 billion in capital raisings over the last three years. The market encompasses a diverse portfolio of products dominated by renal dialysis equipment and incontinence devices. Asia-Pacific leads the market with a 43 per cent share, followed by North America and Europe. Overall market perform-

Leading companies in this field, principally from Europe and North America, have invested over $42 billion in mergers and acquisitions and nearly $15 billion in capital raisings over the last three years ance across geographies is influenced by decisions on inhouse production, partneringlicensing agreements, and mergers and acquisitions. However, the incontinence devices category is expected to show the fastest growth rate with a compound annual growth rate (CAGR) of 4.7 per cent between 2016 and 2023,

closely followed by the renal dialysis equipment category with a CAGR of 4.4 per cent for the same period. According to Andrew S Thompson, Director of Therapy and Analysis for Medical Devices at GlobalData, “This report indicates that renal dialysis equipment will maintain a lead in the nephrology

and urology devices market, however incontinence devices are an area to watch out for, given the projected increases in demand, coupled with a healthy product pipeline.” In 2016, renal dialysis equipment accounted for over 55 per cent of the market value, at over $17 billion, and this is expected to grow to

over $26 billion by 2026. According to GlobalData’s researchers, almost 60 per cent of renal dialysis patient growth will be driven by the emerging markets of China, Brazil, and India, which will account for 48 per cent of the dialysis population by 2026. Thompson commented, ”For companies operating in the renal dialysis space this level of growth presents a huge opportunity to maintain their competitive advantage by driving volume and value sales and profitability.” Recent moves to liberalise private healthcare access in markets such as China will also support this area of growth. EP News Bureau

Global HER2-positive breast cancer market to face challenges from biosimilars through to 2025 The long-anticipated launch of oncology biosimilars in 2017 will be closely watched as drug makers expect to struggle with biosimilar erosion of their own biologics THE HUMAN epidermal growth factor receptor type II (HER2)-positive breast cancer space across the eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and China, which is set to hit $9.89 billion in 2025, is likely to face barriers due to the introduction of new biosimilars, according to GlobalData. The company’s latest report states that the long-anticipated launch of oncology biosimilars in 2017 will be closely watched as drug makers expect to struggle with biosimilar erosion of their own biologics. In the HER-2-positive breast can-

42 EXPRESS PHARMA August 16-31, 2017

cer market, the EU and Japan patents protecting Herceptin expired in 2014, meaning that biosimilar trastuzumab can enter the marketplace, while the drug’s patent in the US will not expire until 2019. Maxime Bourgognon, Senior Healthcare Analyst, GlobalData explains, “Trastuzumab biosimilars are now under review with the EMA and FDA, and the first biosimilar was filed for approval in Japan in April 2017. Considering the generally high uptake of biosimilars in the European markets, the launch of trastuzumab biosimilars is expected to have a significant ef-

GlobalData believes the impact that trastuzumab biosimilars will have on the HER2-positive breast cancer space could be limited in markets where subcutaneous Herceptin was already sold at a cheaper price to its intravenous counterpart fect on the market landscape. “While physicians across all

markets remain cautious when extrapolating clinical bioequiva-

lence data, payers are expected to support switching to the cheaper alternative. Despite the growing portfolio of other HER2-targeted agents, this could be the first significant challenge to Roche’s stronghold on the market.” However, GlobalData believes the impact that trastuzumab biosimilars will have on the HER2-positive breast cancer space could be limited in markets where subcutaneous Herceptin was already sold at a cheaper price to its intravenous counterpart. EP News Bureau

RESEARCH UPDATES

Stopping statins after stroke may increase second-stroke risk Statins work by inhibiting the liverâ&#x20AC;&#x2122;s ability to produce cholesterol while also helping the liver remove existing fats in the blood

topping cholesterol-lowering drugs soon after a stroke may increase the risk of a second stroke, according to a new study from Thailand. People who stopped taking statin drugs within three to six months after a stroke were 42 per cent more likely to have another stroke within a year, compared to people who kept taking the medication, researchers found. â&#x20AC;&#x153;These findings suggest that providers and atherosclerotic stroke patients should not discontinue statin therapy unless there is a highly compelling reason for doing so,â&#x20AC;? write Dr Meng Lee, of Chang Gung University College of Medicine, and colleagues in the Journal of the

American Heart Association. Nearly 800,000 people in the US have a stroke each year, according to the Centers for Disease Control and Prevention (CDC), including 610,000 who are having a stroke for the first time. Statins include the drugs atorvastatin, known commercially as Lipitor; rosuvastatin, also known as Crestor, and simvastatin, or Zocor. They work by inhibiting the liver's ability to produce cholesterol while also helping the liver remove existing fats in the blood, according to the CDC. The drugs are almost universally prescribed to people who have had cardiovascular events like heart attacks or strokes. Additionally, the US Preventive

Services Task Force recommends the drugs to people ages 40 to 75 who don't have heart disease but who do have one or more risk factors and a 10-year risk of a heart attack or stroke of at least 10 percent. For the new study, re-

searchers used data from 20012012 from the Taiwan National Health Insurance Research Database, which includes medical information for most people in the country. They included 45,151 people who had an ischemic stroke, which is caused by a blocked blood vessel. All were prescribed a statin within 90 days of leaving the hospital. After three to six months, seven per cent were on a reduced statin dose and 18.5 per cent had been taken off the drugs entirely. The researchers found that 6.2 per cent of people who stopped taking statins ended up with another stroke within a year, compared to 4.4 per cent of those who stayed on at least a

moderate dose of the drugs. There was no significant difference in risk between those who were on a reduce statin dose and those on at least a moderate dose. The new results jibe with previous research, said Dr Joshua Willey, who is a specialist in vascular neurology at Columbia University Medical Center in New York. "This would argue even in the short term - even in the first year - stopping medication could have a potential harms," said Willey, who was not involved with the new study. He said that stroke patients often ask doctors about statin side effects or information they read online. Reuters

RESEARCH

Lilly’s acute migraine drug succeeds in late-stage study The company is expected to file a US marketing application for lasmiditan in the second half of 2018 DRUGMAKER ELI Lilly and Co said its acute migraine drug lasmiditan succeeded in a key late-stage study, setting the stage for US regulatory approval. About 40 million Americans suffer from migraine - intense headaches characterised by throbbing pain and sensitivity to light and nausea. The disorder, which can last for days, is incurable. The size of the migraine market is expected to balloon to more than $10 billion in 2025 from $3 billion in 2015 in the US and other developed countries, healthcare research firm Decision Resources Group said last year. A clutch of drugmakers including Lilly are racing to grab a piece of this lucrative, underserved market. Lilly’s trial tested three doses of lasmiditan against a placebo. Patients in the trial had an average of more than five migraine attacks per month.

At two hours following the first dose, a higher percentage of patients treated with lasmiditan were migraine painfree compared to those on a placebo, meeting the study’s main goal. Indianapolis-based Lilly originally discovered lasmiditan, but licensed out the oral drug to CoLucid Pharmaceuticals in 2005. Lilly bought CoLucid for $960 million earlier this year. Lilly said it expected to file a US marketing application for lasmiditan in the second half of 2018. Currently, migraine patients are treated with triptans, a class of drugs that hit the market in the 1990s. Triptans work by constricting blood vessels in the brain and cannot be used in up to 35 per cent of patients due to high cardiovascular risk. A host of other drugs - including anti-depressants, medicines for hypertension and even botox - are also used

to treat migraine, but with little success. Lilly has another migraine drug in development called galcanezumab, which works differently from lasmiditan and targets a protein associated with pain signaling called CGRP. Unlike lasmiditan, galcanezumab is being evaluated as a treatment to prevent migraines in patients who suffer from a severe form of the disorder. Companies including Amgen, Teva, Allergan, Biohaven and Alder Biopharmaceuticals also have CGRP drugs to prevent and treat migraine in the latter stages of development. Amgen submitted a US application to market its migraine drug, erenumab, in May. Migraine costs the US about $36 billion in healthcare and lost productivity, according to the Migraine Research Foundation. Reuters

Bristol-Myers to buy IFM Therapeutics to strengthen cancer pipeline The acquisition will give Bristol-Myers access to the company’s preclinical cancer programmes BRISTOL-MYERS Squibb Co said it would buy privately held IFM Therapeutics for an upfront payment of $300 million, as the drugmaker looks to bolster its cancer portfolio after losing ground to Merck & Co's rival treatment Keytruda. The acquisition of IFM, whose backers include Novartis, will give Bristol-Myers access to the com-

44 EXPRESS PHARMA August 16-31, 2017

pany's preclinical cancer programmes. IFM investors are also eligible to additional contingent payments of up to $1.01 billion upon the achievement of certain milestones, the companies said. Bristol-Myers, which is also under pressure from activist investors, expects the deal to close during

the third quarter. The drugmaker has fallen behind Merck in the key field of immuno-oncology after its Opdivo drug failed to prolong survival in previously untreated patients with non-small cell lung cancer, the largest cancer market. Reuters

RESEARCH

FDApanel votes against approval of J&J arthritis drug Panelists were reluctant to recommend approval of Sirukumab as there are two other drugs on the market in the same class THE BENEFITS of Johnson & Johnson's experimental rheumatoid arthritis drug Sirukumab do not outweigh the risks, an advisory panel to the US Food and Drug Administration concluded. The panel voted 12-1 that the drug should not be approved, citing safety concerns, including an imbalance in the number of deaths in patients taking sirukumab compared with those taking a placebo. The most common causes of death were major heart problems, infection and malignancies. “The safety is not there,” said Dr Beth Jonas, interim head of the division of rheumatology at the University of North Carolina School of Medicine. The FDA is not obliged to act on the recommendation of its advisory panels but typically does so. J&J originally developed the drug with GlaxoSmithKline. GSK recently said it would return all rights to J&J. GSK held rights to the drug in North, Central and South America. Sirukumab blocks a cytokine in the

body known as interleukin 6 (IL-6) that can contribute to the inflammation associated with rheumatoid arthritis, an autoimmune disorder that affects more than 1.3 million. Panelists said they were especially reluctant to recommend approval of sirukumab because there are two other drugs on the market in the same class. These are Roche Holding's Actemra and Sanofi and Regeneron Pharmaceuticals’ Kevzara. "If this was a new agent I would probably be a little more enthusiastic," said Dr Maria Suarez-Almazor, rheumatology section chief at the University of Texas MD Anderson Cancer Center. "There is no reason to think that this new drug will act in a tremendously different way." The FDA, in briefing documents released, noted that the trend toward increased overall mortality seemed unique to the sirukumab programme.

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Reuters

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RESEARCH

Blood pressure fluctuations linked to dementia People with the most variation in daily blood pressure readings at the start of the study were more than twice as likely to develop Alzheimer’s disease PEOPLE WHOSE blood pressure varies widely from day to day may be more likely to develop dementia than adults who have fairly steady blood pressure, a Japanese study suggests. Researchers examined data from one month of daily home blood pressure readings for 1,674 older adults without dementia. During the next five years, compared to individuals with little to no fluctuation, people with the most variations in blood pressure were more than twice as likely to develop dementia. “The present study demonstrated that an increased day-today blood pressure variation (measured at home) was significantly associated with the development of all-cause dementia, vascular dementia, and Alzheimer’s disease, regardless of average home blood pressure,” said lead study author Dr Tomoyuki Ohara, of the Graduate School of Medical Sciences at Kyushu University in Fukuoka City. While the study didn’t assess why this might be the case, it’s possible that daily variation in blood pressure might cause

changes in the brain’s structure and function that contribute to the development of dementia, Ohara said by email. Consistently high blood pressure, or hypertension, is a known risk factor for dementia. Previous research has also shown a link between cognitive impairment and dementia and different blood pressure readings at the doctor’s office. Home monitoring might give a more reliable snapshot of blood pressure than tests at the doctor’s office because stress or anxiety about these exams sometimes leads patients to have higher blood pressure at the office than they do at home, a so-called 'white coat' effect. Participants in the current study were 71 years old on aver-

age. For one month, they typically measured their blood pressure three times each morning before eating breakfast or taking medication. About 43 per cent of them took drugs to manage high blood pressure. Researchers reviewed data from blood pressure readings taken during that month, conducted cognitive testing to uncover the development of dementia, and reviewed medical records for the occurrence of stroke. Five years later, 134 participants had developed Alzheimer’s disease and 47 had developed what’s known as vascular dementia, which results from diminished blood flow to the brain and is often related to the occurrence of small strokes.

People with the most variation in daily blood pressure readings at the start of the study were more than twice as likely to develop Alzheimer’s disease and almost three times more likely to develop vascular dementia, researchers report in Circulation. Among participants with the most variability in blood pressure, higher systolic blood pressure (the top number in a blood pressure reading) in particular increased the risk of vascular dementia but didn’t appear to heighten the odds of Alzheimer’s disease. Systolic pressure is the pressure blood exerts against artery walls when the heart beats. One limitation of the study is that researchers lacked data on changes in blood pressure after the initial home monitoring period and didn’t have information on any lifestyle changes or medications people may have used to control blood pressure during the five-year follow-up period, the authors note. It’s also possible that fluctuations in blood pressure could be a symptom of cognitive decline in progress rather than a risk factor for developing dementia in

the future, Dr Costantino Iadecola, Director of the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine in New York writes in an accompanying editorial. Iadecola noted that, presently, doctors don’t know how to reduce variability in blood pressure. “The key question to be answered is whether interventions to control blood pressure variation, once available, would reduce dementia risk,” he said by email. “In the meantime, the takehome message is that the health of the cardiovascular system is of paramount importance to the health of the brain,” Iadecola added. “Even if specific measures to target blood pressure variation may not be available at this time, maintaining general cardiovascular health through lifestyle changes (diet, exercise, etc.) and control of risk factors (diabetes, hypertension, smoking, obesity, etc.) remain the most sensible approaches to stave off dementia.” Reuters

HIV pre-exposure prophylaxis can be taken as needed The researchers found that about 14 per cent of study participants reported minor stomach issues that eventually cleared up MEN AT risk for HIV infection can safely take pre-exposure prophylaxis (PrEP) when they need it, instead of every day, suggests a new study. In a study of gay and bisexual men, researchers found that taking four doses of PrEP around the time of sexual activity cut the risk of being diagnosed with HIV by 97 per cent. The pill, marketed by Gilead as Truvada, contains a combination of the two antiHIV drugs emtricitabine and tenofovir disoproxil fumarate.

46 EXPRESS PHARMA August 16-31, 2017

Truvada was approved by the US Food and Drug Administration for PrEP in 2012. Typically, the pill is taken daily. The participants and the dosing schedule used in the new study were drawn from the IPERGAY clinical trial, which was discontinued early in 2014 after the drug was found to be highly effective at protecting against HIV. "There are consistent data suggesting that on-demand PrEP before and after sex strictly following the IPER-

GAY dosing schedule is also highly effective and could be an alternative to daily PrEP," said Dr Jean-Michel Molina, lead author of the new study and principal investigator of the trial. The 361 men in the new study were enrolled from France and Canada after the completion of the IPERGAY trial. They were told to take two doses of Truvada between two and 24 hours before sex, another dose 24 hours later and a fourth dose 24 hours af-

ter that. One participant who stopped taking PrEP during the roughly 18 months of follow-up was diagnosed with HIV, researchers reported July 23 in The Lancet HIV to coincide with presentation at the 2017 International AIDS Society Conference in Paris. The overall rate of HIV among those in the study was 0.19 cases per 100 people per year. That compared to 6.60 cases per 100 people per year among men who were assigned

to take a dummy pill during the larger trial. The researchers found that about 14 per cent of study participants reported minor stomach issues that eventually cleared up. Only four men stopped using the medication. There was an increase in condomless sex. While high, the rate of sexually transmitted infections did not increase over the study period, said Molina, of Hopital Saint-Louis in Paris. Reuters

RESEARCH

Gum infections linked to several cancers in women The biggest risk was for cancer of the oesophagus, which was three times more likely in women with periodontal disease OLDER WOMEN with gum infections are more likely to get many common cancers than their peers who have perfect oral health, a recent study suggests. Researchers focussed on what’s known as periodontal disease, serious infections in the mouth that are caused by bacteria in dental plaque. Daily brushing and flossing can prevent gingivitis, the milder form of periodontal disease, but untreated cases can lead to permanent damage to the gums and bone. Compared to women without oral health problems, women with periodontal disease were 14 per cent more likely to develop cancer, the study found. The biggest risk was for cancer of the oesophagus, which was three times more likely in women with periodontal disease. Women with periodontal disease were also 31 per cent more likely to be diagnosed with lung tumours, 73 per cent more likely to get gallbladder cancers, 13 per cent more likely to have breast tumours and 23 per cent more likely to have melanoma. “We know that periodontal disease can lead to tooth loss if not treated, and it is also associated with diabetes and other chronic diseases,” said senior study author Jean Wactawski-Wende, dean of the School of Public Health and Health Professions at the University at Buffalo in New York. “Here we found an association with cancer,” Wactawski-Wende said by email. “Although not certain, maintaining optimal oral hygiene may help to reduce the risk of developing cancer.” Periodontal disease was associated with increased risks of several types of cancer in postmenopausal women, even in women who had never smoked, researchers note in the journal Cancer Epidemiology, Biomarkers and Prevention. Compared to women without periodontal disease, current and former smokers with these oral infections were roughly 20 per cent more likely to develop cancer. Certain cancers, such as breast cancer, lung cancer, and gallbladder cancer, were associated with higher risk in smokers with periodontal disease. Others, such as melanoma, were associated with higher risk in women who had never smoked but did have periodontal disease.

The data are from 65,869 women aged 54 to 86 who answered surveys between 1999 and 2003. By 2013 - after an average follow-up of more than eight years - researchers had identified 7,149 cases of cancer. While the exact causes for the connection between periodontal disease and cancer aren’t clear, it’s possible that bacteria travels from the mouth to other parts of the body, Wactawski-Wende said. Bacteria destroy connective tissue between the teeth and gums, forming pockets where the infection can persist and eventually be ingested or inhaled from saliva or enter the bloodstream through inflamed gums, Wactawski-Wende said. Then, bacteria may lodge in other body sites causing inflammation that may increase the risk of cancer. The study wasn’t a controlled experiment designed to prove how or if poor oral health causes cancer. Another limitation is that the study relied on women to accurately recall and report their periodontal disease, the authors note. Even so, the findings build on earlier research linking periodontal disease to an increased risk of cancer, said Jiyoung Ahn, a population health and environmental medicine researcher at New York University Perlmutter Cancer Center in New York City, who wasn’t involved in the study. “It is clear that good oral hygiene and regular dental visits are basic components of maintaining good oral health,” Ahn said by email. “This study provides a rationale for having good oral health for cancer prevention.” Reuters

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RESEARCH

Research finds bacterial plasmids readily pick up new genes and spread them to new species New research is an important contribution to understanding bacterial evolution NEW RESEARCH from the University of Sheffield has found that bacterial plasmids readily pick up new genes and spread them to new species – something which is an increasing concern for transfer of antibiotic resistance between bacterial species. Plasmids are circular molecules of DNA which can copy themselves between neighbouring bacteria. They can be beneficial to bacteria when they carry useful genes, but where the genes they carry aren’t useful, plasmids are often burdensome, acting a bit like parasites as they spread between bacteria. Scientists from the University’s Department of Animal and Plant Sciences discovered that plasmids may be best at spreading genes between species when they act like parasites, rather than when they are beneficial. In the study, published in Nature Ecology and Evolution, the Sheffield team in collaboration with scientists from the Universities of York and Liver-

pool, set up bacterial populations in soil ‘microcosms’. These consisted of a small volume of soil inoculated with bacteria carrying a plasmid that was beneficial in the presence of mercury. By adding small amounts of mercury, the researchers could control whether the plasmid was beneficial or parasitic. The researchers allowed the bacteria and plasmids to evolve under these conditions for hundreds of generations, before sequencing their genomes. Dr Jamie Hall, lead researcher on the study from the University of Sheffield, said: “We were really surprised by the sequencing results.

“In several populations the plasmid had picked up genes from one species and spread them to another. We knew this could happen but we weren’t expecting to see so much of it. Most interestingly, the plasmid was best at picking up genes and transferring them between species when it acted like a parasite. “If the plasmid is useful, then bacteria tend to inherit it from their parent. But if the plasmid is not useful then bacteria are more likely to pick it up from their neighbours — and thus are more prone to picking up their neighbours’ other genes too.” He added, “If we imagine

that bacteria are like PC computers from the 1990s the genes they swap are programmes and plasmids are like floppy disks – able to copy themselves as well as any other genes they might carry between neighbouring bacteria.” Bacterial evolution, particularly resistance to antibiotics, is an emerging public health threat. Plasmids can also pick up and transfer antibiotic resistance genes, so the results of this study indicate concern for places like hospital plumbing and waste-water treatment plants which may provide opportunities for plasmids to move genes between species. “Our research shows that bacteria can evolve rapidly, particularly by picking up genes from their neighbours, and that plasmids may play an important role in this process,” said Dr Hall. “Understanding the conditions that favour plasmid spread is an important piece in this puzzle.” EP News Bureau

AstraZeneca gets breakthrough status for blood cancer drug The US Food and Drug Administration decision clears the way for a speedy regulatory review ASTRAZENECA said that US regulators had awarded its blood cancer drug acalabrutinib ‘breakthrough’ status for the treatment of patients with mantle cell lymphoma, a rare type of blood cancer. The US Food and Drug Administration decision clears the way for a speedy

48 EXPRESS PHARMA August 16-31, 2017

regulatory review and comes a day after another of its drugs, Imfinzi, won breakthrough designation for non-metastatic lung cancer. Both developments represent pluses for AstraZeneca's cancer portfolio following the initial failure of the key Mystic trial

in lung cancer. AstraZeneca acquired acalabrutinib after buying Acerta Pharma in 2015. The drug is being developed for a variety of cancer types. Reuters

FDA approves AbbVie’s hepatitis C drug THE US Food and Drug Administration approved AbbVie's drug to treat certain adults with chronic hepatitis C. The drug, Mavyret, aims to treat hepatitis C genotypes 1 through 6 in previously untreated adults with or without mild cirrhosis, a

type of liver disease, including patients with moderate to severe kidney disease and those on dialysis. Mavyret is the only eightweek duration treatment approved for all hepatitis C genotypes, the FDA said. A standard treatment for hepatitis C has a duration of 12weeks or more. Hepatitis C genotypes, or strains, are genetically distinct groups of the virus. Hepatitis C is a viral disease that causes inflammation of the liver and can lead to diminished organ function or liver failure. An estimated 2.7 million to 3.9 million people in the US have chronic hepatitis C infection, according to the Centers for Disease Control and Prevention. Reuters

RESEARCH

Cancer therapy eliminates toxic delivery vehicles for microRNA The research was funded by Pathway to Independence, the Purdue Centre for Cancer Research, the Indiana Clinical and Translational Sciences Institute and the National Centre for Advancing Translational Sciences RESEARCHERS AT Purdue University have discovered a mechanism for delivering tumor-suppressing microRNAs that eliminates the need for toxic delivery vehicles. This research was funded by Pathway to Independence, the Purdue Centre for Cancer Research, the Indiana Clinical and Translational Sciences Institute and the National Centre for Advancing Translational Sciences. As cancer treatment moves toward targeted therapies, drug resistance is becoming a cause for concern. Cancer cells evolve rapidly, so if the agent used to treat it only targets one gene, that gene is likely to become resistant. MicroRNA often have many relevant targets, making it unlikely that the cancer cells will develop resistance. MicroRNAs, or short strands of RNA, play a key role in regulating gene expression. In the lab, they’ve been successful in shrinking tumours; the best of them act like a “multidrug cocktail.” However, getting the microRNA to the tumor hasn’t been easy. “RNAs are inherently unstable; they’re subject to being degraded in the bloodstream. It’s been hypothesised that if we want to use RNA as a therapy, we have to protect it,” said Andrea Kasinski, a biology professor at Purdue who worked on the study. “Protective vehicles are usually some sort of nanoparticle, often a lipidencapsulated particle. Although the RNA is protected, the protection typically comes at a price.” These particles tend to be a little larger, so penetrating the dense architecture of the tumour can be difficult, she said. Many of these lipids are also toxic. In an attempt to solve this problem, Kasinski’s team abandoned the delivery vehicle entirely. Instead, they conjugated the RNA to a molecule of folate. The folate receptor is over expressed on cancer cells but very low on normal cells, which is why they can target a tumour and avoid healthy cells. Folate is also essential to the human diet, which eliminates the toxicity

problem. “Folate is generally pro-growth. That’s why cancer cells over express the receptor – they want more folate,” Kasinski said. “We’re just hijacking that idea and saying, ‘Okay, you can have all the folate you want, but we’re going to conjugate it to a warhead that will hopefully knock out the cancer cell.’” Unprotected RNAs can be degraded by two mechanisms – an exonuclease, which cuts the ends and chews inward, or an endonuclease, which cuts into the middle. By attaching the RNA to a folate, the researchers protected at least one end. Whether this is the end that usually gets chewed into, they’re not sure, but folate appears to stabilise the RNA. “We think microRNAs are exceptional for that reason,” Kasinski said. This seems like a promising method for cancer treatment, but so far, it’s only been tested in mice. The same microRNA used in this study, miR-34a, made it to clinical trial and failed. Kasinski’s team believes that one of the reasons it failed is because of the delivery vehicle, but there’s no way to be sure. Even if the RNA is somehow toxic, they’re delivering it at a much lower dose than what was used in the trial, and whatever isn’t taken up by the tumour is cleared from the organism very fast. While this kind of therapy may not replace other methods for cancer treatment, it could help make them more effective. The microRNA in question is cytostatic, not cytotoxic – it won’t kill a cell, but it will stop it from growing. Given in combination with chemotherapy, it would break down the cells’ defences, making them more sensitive to the cytotoxic agent. “I think everything we do scientifically, especially in a cancer lab, moves us closer to an effective cancer therapy. But there’s still more we need to do,” Kasinski said. “Maybe there are other microRNAs that will be better.” EP News Bureau

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IT@PHARMA REPORT

Pharma has highest number of digital primes: India Digital Health Report 2017 The report by D Yellow Elephant analysed 160 India-based companies across four verticals – pharmaceuticals, medical devices and equipment, diagnostics and hospitals

ore than half of the pharmaceutical and healthcare companies in India - multi-national and domestic - have a placeholder presence on digital platforms, and are failing to actively engage with their stakeholders, the ‘India Digital Health Report 2017’ by D Yellow Elephant, revealed. The report analysed 160 India-based companies across four verticals – pharma, medical devices and equipment, diagnostics and hospitals. The companies were studied on 12 key digital and social parameters websites, apps, Facebook, Twitter, LinkedIn, YouTube, Google+, Blogger, Pinterest, Flickr, Instagram and Tumblr. Based on presence, engagement, response, and consumer followership, companies are segregated into three categories – digital primes (the torch-bearers), aspirants (gradually moving up on the digital curve) and onlookers (silent observers). Findings reveal that only 14 per cent companies emerged as digital primes. 54 per cent companies qualify as digital aspirants while the remaining 32 per cent fall under the category of digital onlookers. Of the four industry verticals, pharma accounts for the highest number of digital primes (22 per cent). medical devices and equipment and diagnostics have maximum digital aspirants, with 71 per cent of the surveyed companies maintaining digital presence but lagging in engagement. Apollo Diagnostics takes the overall top spot with a score of 70, followed by GE Healthcare with 65.5 and Pfizer with 65 points. Amongst hospitals, Kokilaben Dhirubhai Ambani Hospital leads with 56 points. LinkedIn enjoys the maximum presence with 91 per cent players having a dedicated page, but only 11 per cent companies actively engaging on the platform. Facebook is the second most preferred platform with 90 per cent presence rate, followed by Twitter and YouTube. The long-term aim of this report is to outline the digital integration required at all steps of a patient’s journey, from searching for symptomatic information, HCP interaction, diagnosis, treatment and follow ups.

50 EXPRESS PHARMA August 16-31, 2017

NEWS

CAMS partners with hCue The partnership will help pharmacy retailers and distributors file and reconcile their tax returns and make them compliant with the current GST regulations COMPUTER AGE Management Services (CAMS), a leading and integral part of Indian financial infrastructure co-owned by NSE Strategic Investment Corporation, HDFC Group and Acycs has engaged with India’s leading healthcare technology company hCue to help pharmacy retailers and distributors file and reconcile their tax returns and make them compliant with the current GST regulations.

hCue Pharmacy Software and Clinic Management System seamlessly plug into CAMS integrated GST Platform, GST easy which would help healthcare professionals file GST with a single click. Commenting on this engagement, Ravi Kiran of CAMS said, “CAMS GST easy enables organisations to seamlessly comply with Goods Services and Tax (GST) regime. Being a GSP and an Application Service Provider

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(ASP), GST easy provides features that enable hassle-free uploading and submission of data. The cloud-based technology platform is scalable with the ability to address taxpayer having one or more registration as well as companies with multiple subsidiaries. The system is built to give users a single view of tax with actionable insights and dashboard embedded.” hCue-CAMS platform will be a full suite solution to meet the

needs of all the relevant players in the Healthcare ecosystem like pharmacy retailers, distributors and the clinics (wherever GST is applicable). The pharmacists and clinics using hCue-CAMS platform can create GST compliant sales and purchase invoices from day one of the GST regime, reconcile their GST forms, reduce working capital, have access to all the analytics and dashboards easily from their mobile apps.

“Through regular interactions with our customers, we observed that a lot of them were concerned and unaware about the various aspects of GST. On a war footing, we then decided to partner with CAMS to provide a seamless solution for pharmacy retailers and distributors to file and reconcile their tax returns,” said Vijay Thirumalai, CoFounder, hCue. EP News Bureau

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PHARMA TECHNOLOGY REVIEW

Making sense of serialisation With more than 40 countries already implementing or set to enforce their serialisation mandates by 2018, are pharma exporters from India geared up to face this challenge? Viveka Roychowdhury

magine a world where all medicines, from strips of tablets to syrups to vaccines, in every chemist shop in the world, from Africa to America to India, has a unique serial number with information on the origin, shelf life and batch number. If all these numbers can be stored, tracking a substandard or counterfeit medicine to the exact location where it was produced becomes much easier. Actually, serialisation, or the process of marking products with unique identifiers, is already a reality in most countries for a variety of products, from FMCG to toys to medicines. The next logical level of security is to use these serial numbers, which in most cases is a unique number of alphanumeric code, most commonly encoded into a barcode, to track each pharma product as it moves through the supply chain, from the time it leaves the manufacturer's gate, to the stockist/distributor and finally to the chemist shelf. A further level of security is to be able to trace back the journey of each pharma product. Serialisation, combined with track and trace mechanisms, are being seen as one important solution to ensure that substandard or counterfeit medicines are discovered before they do too much harm so that they can be recalled from global markets.

The case for serialisation The pharma sector thrives on exports and more so the companies from India, resulting in the country being often referred to as the 'pharmacy of the world'. According to India Brand Equity Foundation

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India has no choice but to be part of the global mandate for serialisation, followed by track and trace systems

(IBEF), India is the largest supplier of generic medicines globally, accounting for 20 per cent of the global export volume. Pharma exports from India stood at $16.4 billion in 2016-17, and is expected to reach $20 billion by 2020, as per estimates from the Pharmaceutical Export Promotion Council (Pharmexcil). India thus has no choice but to be part of the global mandate for serialisation, followed by track and trace systems. India's serialisation initiative for pharma products

started in January 2011, when the Directorate General of Foreign Trade (DGFT), launched the country's track and trace system for all pharma products exported from India. The US, the biggest pharma market of the world, has its serialisation mandate, known as the Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27, 2013. Though it is set to be implemented by November 27 this year, enforcement of the product identifier requirement was

postponed by a year. The European Union (EU), another important destination for pharma exports, has the Falsified Medicines Directive (FMD), under which new track and trace regulations come into force from February 2019. Countries like Belgium, Greece and Italy have reportedly already made serialisation mandatory. Turkey is often cited as an early bird example of having one of the longest standing track and trace systems in place for all pharma products.

S E R I A L I S AT I O N S

It is always advisable to stick to the existing plan and implement it as soon as possible. This will allow the organisation to conduct some trials and testing to avoid market complaint. Every country has their own regulations which creates difficulty for the manufacturers Shivaji Chakraborty Asst GM, Packaging Development, Fresenius Kabi Oncology

With more than 40 countries already implementing or set to enforce their serialisation mandates, most important export destinations will require some level of serialisation/ traceability in place by 2018. How prepared are pharma exporters from India to face this challenge? Will they lose out on their competitive advantage to exporters from other countries? As usual, there are the early birds and the laggards. Shaunak Dave, VP, Asia and CEO and MD, India, Optel Group, points out that outside the US, the maximum number of US FDA plants are located in India and these plants do not have any choice but to comply with US DSCSA regulations. He reveals that the Optel Group started serialisation projects in India around 2011-12 and most big and medium size pharma exporters are today equipped with serialisation at the secondary and tertiary packaging levels to meet India's export regulations. “Many companies exporting to the US are ready with serialisation but aggregation is still a work in progress as it is not a mandatory requirement as of now. However, it is the requirement from their master distributors and business partners.”

Multiple standards, multiple complications …

I personally believe this is a little bit far fetched but technically speaking, yes, the risk exists Jean-Pierre Allard CTO, Optel Group

Serialisation has been successfully implemented in many other sectors, but pharma serialisation has turned out to be more complicated. Comparing the mandates of various countries, Pradeep Dhargalkar, Head of Packaging Development, Unichem Laboratories says, “The four basic data to be serialised remains the same across mandates: i.e. batch number, expiry, GTIN, and serial number. In the EU, apart from serialisation, the pack also needs to be tamper evident.” But regulators of countries have not been able to agree on which standard to

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follow. Even when they do decide on a global standard, (GS1 seems to be the most common choice), there are differences in the interpretations, which has turning out to be a nightmare for manufacturers. “Since there is no single global standard, every country has adopted their own regulations, which has made it difficult for manufacturers,” says Shivaji Chakraborty, Asst. GM, Packaging Development, Fresenius Kabi Oncology. He also points out that the Indian guideline is for products which are exported from India, not for products which are being sold in the domestic market. By this logic, manufacturers would need to have different packaging lines for export and domestic markets, adding to the capital expenditure by way of labour costs, separate storage areas, etc. Explaining further, Dave says,“India's serialisation guidelines are based on the GS1 standard which is adopted by a majority of countries who have announced this compliance. A few countries like China mandated different standards. Considering the implementation issues, the regulations are under review in China and industry experts believe that it will also be aligned with GS1 global standard.” Differences in interpretation snowball into implementation challenges across the supply chain. For example, Dave points out that while the Indian regulatory authority's standards are based purely on the definition of packaging (primary, secondary and tertiary) and therefore considers primary packaging as the first level of serialisation (although this is on hold), this view is not aligned with global mandates from various countries. As per US DSCSA, EU FMD regulation, serialisation begins with the unit saleable pack, says Dave. He reckons that this is one of the biggest challenges as far as technical

ICRIER-RXGPS RECOMMENDATIONS TO CDSCO ON SERIALISATION ◗ Recommendation 1: CDSCO and DGFT should delegate an independent body to undertake (i) an economic impact assessment for domestic serialisation and traceability requirements under consideration, and (ii) a regulatory impact assessment of existing requirements for serialisation and traceability of exports. ◗ Recommendation 2: With regard to product exported to a country that has its own serialisation requirements, the “tertiary package” should be considered the highest level of shipping container for export. For example, the pallet will typically be the tertiary package for exports to the United States or the European Union.The homogenous case would be the tertiary package for markets where the case is the highest level of container exported.All levels of packaging below the tertiary package (as defined here) should then be exempt from unique identifier and labelling requirements under the India serialisation and traceability regulations. ◗ Recommendation 3: DGFT should grant exemptions on a country-by-country basis, not a manufacturer-by-manufacturer or product-by-product basis. ◗ Recommendation 4: Regulators should not define the GTIN indicator digit; it should be set by the manufacturer, as provided in the GS1 GTIN General Specifications. ◗ Recommendation 5: NIC should revise the DAVA database and portal to: ❏ Segregate the portal interface for exports and domestic product. ❏ Eliminate the primary package serial number field, or at a minimum, permit the field to be left blank. ❏ Eliminate the pricing information field, or at a minimum, permit the field to be left blank. ❏ Eliminate the requirement to upload product photos. ❏ Permit a single manufacturer to repeat serial numbers for different GTINs. ❏ Provide the option and interface for automatic upload of data via web service. ❏ Prevent a company’s data from being visible to other companies. ◗ Recommendation 6: NIC should maintain development and simulation environments to support revisions to the DAVA portal. ◗ Recommendation 7: NIC should establish a clear, predictable process for communicating revisions to the DAVA portal. ◗ Recommendation 8: In the initial phase of requirements for domestic product, CDSCO should require serialisation of the saleable unit. ◗ Recommendation 9: CDSCO should not require manufacturers to capture, maintain, or report any information related to the movement of products by downstream trading partners. ◗ Recommendation 10: CDSCO should adopt a four-year, phased implementation timeframe for domestic requirements. ◗ Recommendation 11: CDSCO and DGFT should consider alternative approaches that limit data volumes. ◗ Recommendation 12: There should be a process for accrediting, certifying, or otherwise auditing serialisation vendors.

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PHARMA TECHNOLOGY REVIEW

Counterfeits are a global issue and the operation nexus is intercontinental. It has to be handled globally with effective synchronisation and harmonisation among various governments and agencies

feasibility and commercial viability is concerned, especially for few packaging configurations like blister, vial and ampoules. Elaborating further on the differences between global mandates, he points out how the EU FMD mandated not only serialisation but tamper evidence on the unit saleable pack. Also, the requirement for aggregation is not specifically mentioned. However, supply chain visibility and efficiency cannot be attained without aggregation which entails transferring ownership of serial numbers across the supply chain partners, ease of reconciliation at the stage of receipt of goods and handling of exceptions such as receipt of goods, rejection, rework, change of package disposition /status, etc.

Shaunak Dave VP, Asia and CEO and MD, India, Optel Group

With serialisation / aggregation, productivity in the initial few months shall be impacted. Over the long term, (we) can expect a drop of minimum two per cent. Many of the Big Pharma companies have already prepared a road map for implementation Pradeep Dhargalkar Head of Packaging Development, Unichem Laboratories

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Delayed DSCSA enforcement an opportunity ... Taking heed of these complications, regulators seem to be giving manufacturers some more time to comply with their mandates. On June 30, a draft guidance published by the US FDA announced that though their serialisation mandate, DSCSA would roll out as scheduled this November, they were postponing the enforcement from November 27, 2017 to November 27, 2018. In a joint response, Delhibased Indian Council for Research on International Economic Relations (ICRIER), in collaboration with the Alliance for Global Pharmaceutical Serialization (RxGPS) stressed that the delay is limited to affixing the serial number and barcode to packages and homogenous cases, and verification activities related to those packages that are not serialised. The draft guidance does not delay any requirements with regard to product that is serialised. Importantly, this means that beginning November 27, 2017, manufacturers must be able to verify (i.e., match the serial number or lot and expiry) packages that are serialised. Verification is required within 24 hours. This requires systems and processes that provide prompt access to the underly-

ing serialisation data generated by the Indian manufacturing site/CMO. ICRIER-RxGPS also states that it should be assumed that FDA expects manufacturers, suppliers, and trading partners to use the additional one-year period as an opportunity to fix problems and challenges, so that necessary systems and process for serialisation—including data exchange between Indian manufacturing site and CMOs and the US manufacturer/site—are in place and functioning by November 27, 2018. To a manufacturer like Fresenius Kabi's Chakraborty, this means that “the authorities will not randomly check consignments. In case of non-compliance, there is no penalty. Companies who have already implemented serialisation have to verify the data within 24 hours in case there is any query from the market/authority.” Adding another dimension, Dhargalkar explains that as per Section 582(b)(1)(C), manufacturers must begin to provide the transaction information, history and statements in electronic format only. He predicts that with serialisation / aggregation, productivity in the initial few months shall be impacted. “Over the long term, (we) can expect a drop of minimum two per cent.”

… or a double edge sword? However, the delay in enforcement of the product identifier requirements under DCSCA might turn out to be a double edge sword. As the joint response from ICRIER-RXGPS points out, “The draft guidance does not address or account for the DSCSA provision on “grandfathering”, which is intended to allow the sale of unserialised product in inventory. The June 30 guidance does mention the forthcoming guidance document on grandfathering of inventory as clarifying the grandfathering rules for packages produced during the enforcement discretion period.

Stakeholders are working to add clarity to this issue and ensure that unserialised product in inventory may be sold. Till such time a guidance is released regarding “grandfathered products”, there will remain some uncertainty about adjustment of production volumes. This, in turn, may inflict losses upon smaller CMOs that are yet to implement the requirements for serialisation.” They also point out that the current draft guidance suggests that the enforcement discretion only applies to products that are sold by the manufacturer before November 27, 2017. This would require careful management of inventory. ICRIER-RxGPS opines that given that US is one of the largest export destinations for Indian pharmaceuticals, the nature of compliance would percolate down to the lowest level in the supply chain. And therefore smaller pharma companies and CMOs which are yet to meet the obligations under FDA’s draft guidance are likely to lose business, at least in the short run. This is because they do not yet possess the wherewithal, due to numerous challenges, including lack of vendors with expertise to provide IT solutions, lack of adequate of capabilities and readiness, etc. Further, it would affect their ability to immediately phase out fixed costs incurred. Summing up, ICRIERRxGPS emphasises that the time should be used to focus both on the process of affixing serial numbers and barcodes and the process of exchanging the data necessary for verification. Companies should not assume that additional delays will be issued.

No time to waste So while pharma manufacturers might be heaving a sigh of relief and be tempted to put serialisation on the back burner as November 27, 2018 seems a long way off, this is definitely not an option. As a joint response from ICRIERRxGPS points out, “One year is not a significant amount of

time for serialisation implementation. Companies should continue to work diligently to implement serialisation. Delays in vendor lead-times for equipment, software, and services impact a CMO’s ability to meet its deadlines. Planning ahead and allowing extra time to anticipate potential delays is prudent.” The authors also point out that there are also approaching implementation deadlines for the EU and Russia; so it is especially important not to delay progress. Chakraborty is of the opinion that, “It is always advisable to stick to the existing plan and implement it as soon as possible. This will allow the organisation to conduct some trials and testing to avoid complaints from the market in future.” Dhargalkar concurs, saying, “Since the implementation date is now postponed by one year, it is more important to see how the overall pharma industry will maintain the tempo for new packing lines machinery with solution providers.” He includes cloud testing with software and also hardware for revising printed packaging components, including labels so as to facilitate systems in the distribution and supply chain.

The legal ramifications “Legally speaking, companies not serialising their product after November 27, 2017 are not respecting the law,” says Jean-Pierre Allard, CTO, Optel Group. Explaining further he says, “To make a parallel, the FDA is like the policeman that tells you he will not arrest people driving under 120 km/h in a zone where the maximum is 100 km/h. If by going at 110 you have an accident and kill someone, there will be more charges against you and you have more chances to be accused as your conduct was illegal. After the draft guidance was issued, some consultants in the serialisation business declared that, similarly, a company that does not serialise in the first year could expose itself to pursuits if a counterfeit version of its product kills or

PHARMA TECHNOLOGY REVIEW

“

There is concern that the country-by-country exemption process has become even more complicated. The situation that must be avoided is that perfectly good product manufactured in India for the US market is delayed or stopped at customs due to confusion on the exemptions—this is a realistic possibility unless the exemption process is simplified and streamlined ICRIER-RxGPS

arms someone. I personally believe this is a little bit farfetched but technically speaking, yes the risk exists.” Analysing the draft guidance Allard says that though it does not does not give more details on the requirements in the law, it however gives an assurance (and this is repeated several times in the document) that no actor within the supply chain (manufacturer, repackager, distributor, wholesaler) will be penalised by any means if they produce or transact products without a serial number produced between November 27, 2017 and November 26, 2018. “Basically, it gives one more year to manufacturers to be compliant,” is his interpretation. From the solution provider point of view too, Allard cautions that ''by no means (should) the extension in enforcement be seen as a signal to stop the (serialisation) effort. The extension allows solution providers to breathe more and to increase the quality (more checks) instead of focussing primarily on the delivery time.” For manufacturers that did not started yet, it allows them to stay in business and they must see this one year as their last chance to become compliant, is his advice. Addressing manufacturers who are in the process of working towards compliance or already compliant, Allard says they must see this one year as an opportunity to run serialised batches as much as they can and to take the time to analyse their process and make changes and tests so that the extra step of serialisation is not reducing their

throughput.

A work in progress There is no doubt that serialisation is a steep learning curve, so how are pharma companies in India coping? Optel Group's Dave reveals that just a handful of companies from India have completely implemented end-toend solutions. So also, very few of them have started considering compliance with EU FMD regulations and implementation guidelines. Dhargalkar confirms that Unichem Laboratories is already compliant to Indian DGFT requirements for serialisation. As far as other export destinations are concerned, they are in the process of getting compliant to the US requirements while (compliance to) EU will be completed before their implementation date. Thus, Dave opines that the one year delay in enforcement for US DSCSA is positive news for the Indian pharma industry “if we take advantage of it to re-validate serialisation strategy in a holistic way and start acting now. Late implementation means compromise on quality, stressful working and (being) susceptible to serious business risk.”

Working together While the US FDA might seem to be doing the industry a favour by recognising 'that some manufacturers may need additional time beyond November 27, 2017, to ensure that products are properly labelled with a product identifier', the delay seems to be driven by their concern 'to

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minimise possible disruptions in the distribution of prescription drugs in the US.' Stakeholders in the serialisation process, including industry associations of pharma distributors, retailers, generic drug manufacturers and solution providers can take some credit for the one year delay. After all, it was their description of the challenges of implementation of product identifier requirements that resulted in the decision to delay enforcement. Lines 90 to 95 of the June 30 draft guidance primarily mention two reasons. Firstly, a limited number of vendors that that have the expertise to provide solutions related to information technology systems for data management or specific equipment for packaging or manufacturing lines. And secondly, the lack of capabilities and readiness of contract facilities that perform manufacturing operations on behalf of the manufacturer. Thus the common challenges posed by serialisation seems to have united competitors. Allard represented the Optel Group, as one of the nine companies at a US FDA public meeting held in October 2016, where these stakeholders expressed concerns about the tight timeline. “We were the only solution provider presenting and I started my speech saying that I was not here to represent Optel, but also to represent my competitors who are in the same situation.” He argued in this presentation that while there were around 15000 packaging lines that needed

BENEFITS OF SERIALISATION BEYOND REGULATIONS ◗ Better rotation of the stock. When one picks a product in the warehouse prior to ship an item, one scans it serial number (its identity), so if the system knows that there are still products, from a previous batch, that are on the warehouse shelves, it will tell the operator to pick the older ones instead (before they expire). ◗ Better quality: When aggregation is used, it becomes almost impossible to pack a shipper case without the correct count.Also, if a product is rejected after any quality check during the packaging, the serial number is identified as “inactive”until someone with the proper access right scans it to change its status back to “active”. In comparison, before serialisation, any one could put back a product on a conveyor and no checks would be done. ◗ Better control: The serialisation solutions produce reconciliation report more precise and accurate than ever. ◗ Better understanding: The serialisation solutions produce performance reports.Thanks to all the timestamps associated with serial numbers events (like print event, inspection event, packing event), the report can give an indication to the packaging engineer where he can improve the packaging process. In other words, it gives a way to become Industry 4.0 compliant.

(Source: Jean-Pierre Allard, CTO, Optel Group) IMAGE: Implementing timeline for manufacturer serialisation of salable units

serialisation, only around one fourth of these lines had been serialised so far. Once again, in April 2017, Optel sent an official letter to the FDA reiterating their concerns about being able to support all the manufacturers to complete the serialisation rollout of the their packaging lines.

The fallout of not being in step Stakeholders in India's pharma sector have held similar interactions with regulatory officials involved with the country's pharma serialisation and traceability initiative. One such meet was convened by the Delhi-based Indian Council for Research on International Economic Relations (ICRIER), in collaboration with the Alliance for Global

Pharmaceutical Serialization (RxGPS), Washington DC in early March this year. The meet was attended by policymakers from India and the US, spanning the Central Drugs Standard Control Organization (CDSCO), National Pharmaceutical Pricing Authority (NPPA), United States Department of Commerce, US FDA, India Field Office, World Health Organization. Industry were associations like Indian Drug Manufacturers' Association (IDMA) and Pharmexcil, civil society (Partnership for Safe Medicines India) and representatives from top pharma companies based in India also attended. Based on discussions at the meet, ICRIER and RxGPS released a white paper in May, titled, 'Implementing India's

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PHARMA TECHNOLOGY REVIEW drug serialisation and traceability requirements to advance patient safety and support global trade'. Importantly, the paper contained 12 key recommendations to CDSCO. (See box: ICRIER-RxGPS recommendations to CDSCO on serialisation) Commenting on the action taken so far on the recommendations, a joint reply from ICRIER-RXGPS states that although the white paper has been circulated among various policymakers and implementation agencies in India, a specific timeline towards addressing these recommendations has not been issued thus far. Commenting on the third recommendation, dealing with country-by-country exemptions, ICRIER-RXGPS says that there is concern that the exemption process has become even more complicated. The situation that must be avoided is that perfectly good product manufactured in India for the US market is delayed or stopped at customs due to confusion on the exemptions—this is a realistic possibility unless the exemption process is simplified and streamlined. Similarly on the fifth recommendation, dealing with serial numbers unique by GTIN, not by manufacturer, NIC committed to make this change to the DAVA database at a March 27th workshop, but no action has been taken. The joint note from ICRIERRXGPS cautions that all of these issues could cause export and distribution of product from India to be stopped.

Beyond serialisation There is no doubt that the implementation of serialisation/ track and trace systems will add to the steps in the manufacturing process. This translates into capital expenditure, loss of time to set up these systems, train the workforce, etc. In fact, the ICRIER-RxGPS white paper of May estimates that the implementation timeline for manufacturers for serialisation of salable units, is as long as 57 months, from the initial stage, project development planning and team se-

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There is no doubt that the implementation of serialisation/track and trace systems will add to the steps in the manufacturing process. This translates into capital expenditure, loss of time to set up these systems, train the workforce, etc lection, followed by capital approval, selecting and securing vendors and partners, procuring long lead items (which could take as long as one and a half years), installing and validating equipment and systems, integrating them with partners and reporting systems before beginning to roll out the actual serialisation process. In a best case scenario, the white paper says that this timeline could be cut down to 46 months, if the procurement of long lead items can be completed in a year's time. Given the heavy investment, are there ways to increase the RoI? Sure there are, claim solution providers and the extra year's time can be used to put in place better

systems and processes to increase RoI. While the prime objective of implementing track and trace is to fight against counterfeits to enhance patient safety, Optel Group's Dave says that supply chain visibility, revenue protection, tax/incentive (for) fraud elimination, protection against diversion, and efficient recall are additional benefits of implementing such solutions. Further spelling out these benefits, his colleague Allard says implementation of serialisation and track and trace systems would lead to better rotation of stocks, better quality, better control and better understanding. (See box: Benefits of serialisation beyond regulations)

Given the multiple mandates and the costs involved, most companies in India are not in a position to think beyond serialisation right now. They would echo Unichem Laboratories' Dhargalkar stance that for now, the focus is on compliance. Fresenius Kabi's Chakraborty also cautions that serialisation can only ensure supply chain integrity if track and trace is implemented. “Serialisation plus authentication can ensure the customer about the originality of the product.”

What happens now? Regulators and industry must realise that with all the investment in serialisation, it is not a foolproof solution. As the ICRIER-RxGPS white paper

published in May this year, cautions, 'Serialisation is one of many tools necessary to ensure quality, authentic products are delivered to patients. It does not, however, address all issues related to pharma quality and safety. In addition, when serialisation information is not properly used or protected, that information can be used improperly to give substandard and falsified medicines the appearance of legitimacy, creating the exact security threats that traceability systems are intended to prevent.' Dave also emphasises the need for global harmonisation of standards and exchanging data between governments, saying,“Counterfeits are a global issue and the operation nexus is intercontinental. It has to be handled globally with effective synchronisation and harmonisation among various governments and agencies.” Regulations are in a constant state of flux, with regulators striving to balance their duty to safeguard the needs of their citizens, as well as work with industry to see how best this can be done. There are early signs that regulators from other countries are taking their cue from the US FDA's delayed enforcement of the DSCSA. For example, while India's DGFT considers primary packaging as the first level of serialisation, it seems to have put this on hold for now. So also, industry observers report that the Government of China is also planning to align with global GS1 standards and may plan for 2D code serialisation. Thus all stakeholders will need to work with, rather against, each other, to set common standards. Only then, can we achieve the common goal of increased patient safety through more secure pharma supply chains. (Disclaimer: Opinions and recommendations attributed to ICRIER are that of its Health Policy Initiative team members and not that of the institution itself.) viveka.r@expressindia.com

PHARMA TECHNOLOGY REVIEW

Serialisation in operational life-cycle and value realisation Arjun Guha Thakurta, Director – Operations, Life Science Consulting, gives a rundown on serialisation, elaborates on its after effects and highlights learnings for the pharma industry from other sectors which have already gone down this route

MANY OF the world’s largest pharma companies converged at the ISPE 2017 Pharmaceutical Serialization Workshop in May 2017 to discuss– what next? I had been invited as a Speaker by ISPE from Asia to discuss on global issues, perspectives and case studies on readiness, planning implementation and harmonisation to ensure product protection. However, soon I realised that most of the pharma majors have almost completed their serialisation implementation programme and are moving towards discussing value realisation of their investment. I remember one of the plenary speakers introduce the concept that serialisation is like your car number plate, (but, you need a lot more in order to drive). Another eminent speaker proclaimed that since 2002 serialisation in aerospace has already been implemented. Today 1000s of serialised parts assembled into each airplane can be traced back to a database of parts to serial numbers for the airplane and reflects real-time true state across the entire lifecycle of the aircraft. Therefore, it is not incorrect to state that for serialisation, pharma industry has a leader to follow and that’s aerospace. In India, we have already witnessed this in our government’s urgency in institutionalising Aadhaar (UID) for unique identification of all citizens and further linking that unique identity with bank accounts, gas, driving license, IT returns, PAN card, GST and so on. Primarily, it helps to authenticate the identity of the owner so that all legal transactions are traceable to the owner and the transac-

tions executed are tracked for each event. This is basically similar to achieving the “1-2-3 Confirm” rule used by pilots in an aircraft.

Serialisation after-effects ◗ Increasing number of stock keeping unit (SKUs) and new launches ❏ Any pharma company will continue to have new launches and product transfers. Such actions requires additional master data maintenance, ensuring the target market serialisation regulations are compatible with the existing serialisation solution and any additional investments thereof. ◗ Decreasing OEE ❏ DIN 8743, used for calculating combined efficiency of multiple sub-processes, will no longer be the basis for calculation due to the added complexity from serialisation, tamper evident packaging, aggregation and many other factors which will have the potential for an OEE drop by eight to 12 per cent. ◗ Decreased flexibility ❏ In an effort to optimise initial investments many companies decide on having some line lev-

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els with serialisation only solution and specific lines with aggregation units. Future launches of new products and new target markets will require additional investments which may not be a part of the launch budget. ◗ High CAPEX and increased OPEX ❏ The extensive use of IT and line level combination for data exchange and management will have significant Cost of Goods Sold (COGS) impact. Many

packaging lines have evolved from machines of the late 90s or 2000s and upgraded over the year by ‘Salami tactic’ (BandAids) with max. OEE around 60 per cent. ◗ Knowledge Management ❏ During the project many external factors comes in play like the equipment vendor, external contractors, SMEs who generally taper off post-implementation. The responsibility for maintaining the system passes on to the shop floor supervisors, operators, local engineering, IT etc. and rooted responsibility generally vanishes. ◗ Additional work routines at all levels ❏ The scope of routines generally extends from a material code creation to the inclusion of serialisation relevant master data inclusion, recipe creation, artworks harmonisation etc. which extends to work routines at all levels. ◗ Supplier dependencies ❏ Serialisation vendor dependencies for line level is seen as one of the key contributing factors for vendor blocking and increased vendor dependencies. A well-crafted service level agreement (SLA) with the ven-

dor will go a long way in handling incidents and issues in the operational lifecycle. ◗ System maintenance ❏ System maintenance includes Service Level Agreements and redundant strategy for plug and play changeovers, spare parts strategy, cleaning strategy of printers (TTO, TIJ print heads), dispensers etc.

Serialisation data elements US DSCSA Serialisation data elements constitutes elements beyond the 2D Datamatrix or the GS 128 1D barcode. For US DSCSA it is important to understand Global Trade Item Number (GTIN) and National Drug Code (NDC). While the GTIN (14 digit identifier) is used to identify all types of trade items across the world, NDC (10 digit identifier) is used only to identify drugs subject to US FDA regulation in accordance with Section 510 of the FDC Act, 21 USC 360. The NDC consists of three segments which specify the drug product’s labeller, trade product and package size. Each NDC code uniquely identifies a specific drug having a

EXPRESS PHARMA

August 16-31, 2017

PHARMA TECHNOLOGY REVIEW particular dosage form, strength and pack size. GS1 US does not require companies to register individual GTINs with GS1 US. Regulated company has to license a GS1 Company Prefix from GS1 US and GS1 US will maintain a record of that. The FDA already requires the NDCs to be registered with the FDA. The DSCSA does not need any additional registration of the NDC beyond that already required, nor does GTINs needs to be registered with the FDA. The DSCSA does not require reporting of Transactional Information (TI) and Transactional History (TH), when ownership of the individual instances of drugs are transferred in the supply chain, and GTINs are used as part of this reporting when GS1 data sharing standards (EPCIS) are used. Standardised Numerical Identification (SNI) includes NDC and a unique serial number (upto 20 characters) generated by the manufacturer or repackager. A SGTIN can be used as an SNI per FDA SNI Guidance Section III (F) which explicitly states that the use of a serialised NDC is compatible with, and may be presented within, an SGTIN. GS1 US recommends the use of SGTIN as a best practice for meeting requirements involving the SNI. Apart from this, Global Location Number (GLN) with Application Identifier (AI) (414) are used to identify a functional entity like a hospital pharmacy or a physical location e.g. warehouse. manufacturers, wholesaler, dispenser, CMO, 3PL or contract packager, pharmacy, doctor, hospital, health facility or other dispenser should have GLN to enable construction of EPCIS event data to meet DSCSA requirements. Application identifiers applicable to DSCSA Requirements

EU FMD However, for EU FMD there are quite some topics which has been succinctly explained by Dr Stefan Artlich, Director Track and Trace, Bayer at the GS1 Global Healthcare Conference in Berlin this year. Coding of multimarket packs is easy if the packs bear only one EAN code today. Germany will allow for GTIN + National Health Reimburse-

58 EXPRESS PHARMA August 16-31, 2017

ment Code (NHRN) the fifth data element e.g. the DE-AT packs. However, whether Spain and Portugal will allow same is still an open topic. This is primarily due to some European countries who continue to require inclusion of their national number (e.g. Germany, France, Brazil) via National Trade Identification Number (NTIN) or National

Health Reimbursement Number (NHRN) using Application Identifier AI (7xx). If the above scenario is considered as a de-facto standard, there are countries who have introduced non-GS1 proprietary coding (e.g. China), then the additional information to the code is further complicated. Apart from the above com-

plexity, the EU Delegated Regulation 2016/16 sets forth requirements on master data reporting e.g. ◗ Product name ◗ Common name ◗ Strength ◗ Pharma norm ◗ Pack type ◗ Article 57 Code / PCID ◗ List of ‘Designated Whole-

Autopilot “1-2-3 Confirm” Rule

Serialization 1-2-3 Rule

1.Altitude Selector

1. Identify (the serialized pack or label)

2. Engage Vertical Mode

2. Scan (operate the scanner)

3. Set Mode value

3.Verify (read the result from the monitor)

Confirm in Flight Mode Display

Confirm Authentic or Spurious Drug Product

salers’ A Master Data Guidance by EMVO (European Medicines Verification Organization), is expected very soon. Considering the fluid global scenario for master data management, a company can consider merger of multiple data points and create their own set of data elements. Example below can serve as a guidance for the industry: ◗ Product Master ❏ SKU # / GTIN ❏ Description ❏ Market ❏ Mandate ❏ Strength/Potency/Form ❏ Quantities per pack level ❏ Group Code ❏ Import/Export ◗ Line Enablement / Configuration

PHARMA TECHNOLOGY REVIEW ❏ Packaging Line ❏ Product Flow ❏ Component Specs ❏ Digital Printer / Camera Specs ❏ Inspection / Reject mechanisms ❏ Recipes ❏ Line Class / Format ❏ Serialised vs Non-Serialised? ◗ Production data ❏ Batch Number ❏ Batch Size ❏ Quantities per shipper (partial) ◗ Serial Number hierarchy ❏ Aggregations ❏ Manufacturing Date ❏ Expiration Date Serialisation data elements constitutes elements beyond the 2D Datamatrix or the GS 128 1D barcode.

What about the data? A third party serialisation data management provider (generally a Cloud vendor) can provide site serialisation services constituting of: ❏ Master data standardisation services ❏ Serial number provisioning services ❏ Notification services This site serialisation services can be integrated with the Company ERP System which consists of: ❏ Integration services – Process order, notification trigger, master data, rework and connects with site servers. ❏ Serialised product data manager – which centralises multiple sites data into a single event repository server. ❏ Reporting services – Dynamic reporting functionality can be developed (country/regulation specific reporting). What do you know about the data? ❏ Interconnected: Better alignment across internal supply chain ❏ Quality: Now we know it is good or we are getting there ❏ Saturation: Not across all markets/manufacturing network ❏ Type: Most likely focussed on compliance (need more data for good analytics) How can you use it effectively and create true interconnectivity across the supply

chain? ❏ Increase accuracy/visibility across the supply chain (work as one) ❏ Reduce waste (eg. expiring products), returns accuracy, metrics driver etc. What else can the data captured by serialisation be used for, in your network? ❏ Investigations – Harmonised data can be successfully used for investigations of product/supply related issues. ❏ Serialised network operations – visibility beyond the manufacturer’s walls to the patient. ❏ Analytics – Data analytics for process improvements (digital factory) and supply chain visibility.

Flexible integrated serialisation solution A flexible and integrated serialisation solution supports the

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regulated company to: ❏ Support recipe driven/classbased configuration ❏ Provide common functionalities across multiple OEM solutions ❏ Support reporting requirements across multiple regulatory mandates ❏ Streamline master data management and administration at the site and enterprise level Serialisation data configuration is the key factor driving operational excellence ❏ Managing the master data across the supply chain Need to establish ❏ Harmonised sources ❏ Establish governance and owners of data sets ❏ Integrate/Automate Operations ❏ No longer just producing physical product

❏ End user change management/embed and optimise ❏ 'Clean Data' at the macro and micro levels

Things to consider ‘Wisdom is not a product of schooling but of a lifelong attempt to acquire it’ – Albert Einstein I always stop short of writing a conclusion or a summary as unlike a research paper, the serialisation world is continually evolving since the last 12 years and will continue to remain fluid till 2025. The pharma industry will continue to invest and implement serialisation technologies and its associated data management infrastructure. The advantage of a technically strong team who can centrally manage issues from various sites and make sure that the installations are working in pristine condition with regular maintenance,

calibrations and data cleansings will become an important factor in the OEE improvements. It is imperative to understand what needs to be reported and what needs to be authenticated, and how, where, when? How will commissioning, decommissioning and recommissioning be done and by whom? What is the exact market demands in details and impacted SKUs? Who are your supply chain stakeholders and partners businesses? Finally, robust metrics to measure your serialisation investment is the way forward.

References 1. Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA, Release 1.0, May 23, 2017 2. ISPE Pharmaceutical Serialization Workshop 8 – 9 May 2017, Philadelphia, PA, USA 3. GS1 Global Healthcare Conference in Berlin on 5th April 2017

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August 16-31, 2017

PHARMA ALLY

Future trends in film coating Swati Rana finds out how film coating technology has evolved over sugar coating technology to cater to the demands of the pharma industry

ilm coating technology plays a vital role in formulation development of drugs. This modern technology is most preferred over sugar coating technology which was invented in 1800s. In India, film-coating is widely used due to its cost effectiveness, whereas, in the global market, more advanced techniques such as fluid bed processing is used for particles as well as tablet coating. Film-coating technology has gone through various modifications to meet the demand of the pharma industry. It is not only limited to the pharma sector but also widely used in FMCG and food industry.

Evolution of film coating technology Film coating has evolved with time, keeping pace with demands of the pharma industry. Necessary modifications were undertaken such as improved production equipment and development of highly-efficient film coating formulations, evaluation and use of new polymers and decrease in use of conventional polymers were undertaken. Girish Kumar Jain, President-R&D, Alkem, explained that each drug has its own characteristics like bitterness, unpleasant odour, light sensitivity, oxidation or hygroscopicity. Tablet coating evolved during the last decade to help in solving such problems and provide formulation which takes care of all these problems with much better patient acceptability. The major attribute of film coating has come up in modulation of released profile of drugs in the form of extended release, enteric coating (delayed release), osmotic pump, pulsatile delivery sys-

60 EXPRESS PHARMA August 16-31, 2017

tem. This has helped to improve bioavailability and therapeutic potential of a drug as well as improved patient compliance.” Newly introduced film coating materials are specially designed considering the sensitivity of active pharmaceutical ingredients (APIs) used in the formulation. Film coatings are available for moisture sensitive drugs and flavoured film coating materials for the products having bad odour and functional coating. “Over a period of time, due to the challenges and demand faced by the pharma industry, there has been significant changes in the production equipment of film coating like conventional coating pans to perforated coated pans, fluidised bed coater etc, coating formulations like organic film coating to aqueous film coating, high solid content premix e.g Instacoat / Opadry etc and polymers like HPMC /PVA etc, which has accelerated the acceptance of coating technology,” said Vinod Arora, Technical & Regulatory Expert, Medicines Patent Pool.

Future trends At present, liquid coating technology is one of the popular technology used for coating solid dosage forms. Generally a mixture of polymers/pigments and excipients are added in organic solvent or water to form a solution or dispersed to form a dispersion and then sprayed into solid dosage forms and dried uninterruptedly by providing heat /air until a dry and smooth coating film is formed. Nowadays, usage of organic solvent in film coating is reduced significantly

due to its toxic / flammable nature, cost and causes environmental pollution/ affects coating equipment operator. “Future trend in film coating will be towards continuous manufacturing and solvent/liquid free coating. Discussions are being held on different modelling systems like digital video imaging, discrete element methodologies, computational fluid dynamics to study various film coating parameters. Process analytical technique will help further monitor and control various unit operations.” Speaking on the improvement which the technology has gone through in the past decade, Pramod Pimplikar, MD, Shalina Laboratories, said, “One major improvement that has taken place in recent years is the shortening of coating process length. This improvement was brought about by using coating solutions with a high solid content thereby reducing the cost. With regards to functional coatings, most of these are non-water soluble and the challenge for coating manufacturers was to stop using organic solvents because of their negative impact on the environment. For non-functional coatings, innovations have been limited because of the commonly used cellulose derivatives and polymethacrylate coatings, which continue to provide satisfactory results for most uses.” “While at present aqueous film coating is firmly entrenched, more work is going on making this coating amenable with use of high percentage of solids. This means less time for coating and less use of energy, thus making coating more productive and less costly. Equip-

ment manufacturers are working on reducing the loss during coating process to make the whole process less costly. However, future trends includes dry coating and electrostatic dry coating,” informed Jain According to Suresh Pareek, MD, Ideal Cures, one of the major trends that this industry is seeing is the insistence on continuous coating over batch coating. With the FDA giving a go-ahead on continuous manufacturing, we will soon see the widespread set up of continuous coaters and in turn the use of high-solid content, novel coating formulations such as INSTACOAT 4G. As machines advances, they will require equivalent coating materials that can shoot up productivity, reducing time and cost. In developing countries, organic solvents are still being used in coating formulation, but the near future will see movement out of these to complete aqueousbased systems. With the introduction of graft co-polymers, the need of adding separate plasticizers/ binders will reduce, reducing the number of ingredients and thus mixing time. “Sugar-coatings seem to be coming back to the market, now modified and redesigned as sugar-fast coatings. Another trend that I foresee is the need for powder/ dry tablet coating, that completely eliminates the need for a solvent. Such coatings will revolutionise the process of tablet coating and will introduce new deposition techniques,” he further said.

Growth drivers Jain feels that the high regulated international markets has opened avenues for

I see the pharma industry adopt continuous manufacturing and in some cases solvent free coating for which a lot of work is going on in different countries with respect to production equipment etc Vinod Arora Technical & Regulatory Expert, Medicines Patent Pool

One major improvement that has taken place in recent years is the shortening of coating process length Pramod Pimplikar MD, Shalina Laboratories

The major attribute of film coating has come up in modulation of released profile of drugs in the form of extended release, enteric coating (delayed release), osmotic pump, pulsatile delivery system Girish Kumar Jain President-R&D, Alkem

Sugar-coatings seem to be coming back to the market, now modified and redesigned as sugar-fast coatings Suresh Pareek MD, Ideal Cures

Indian pharma exports. He informs, “The Indian pharma industry has expanded at a very fast rate especially due to extensive exports. Indian pharma companies have an advantage as markets such as US, Europe and Australia are highly regulated. Better quality of medicines along with requirement of high yields and less wastage has put pressure on film coating industry (coating material supplier and equipment manufacturer) to upgrade film coating material technology. The industry has upgraded from using 10 per cent w/v dispersions to about 30 per cent w/v dispersions presently.” More efficient coating equipment has also helped in reducing the wastage of coating dispersion during coating. This is especially important when drug is used in coating dispersion. Similar factors are driving the growth in global markets. “The growth of the excipient industry and in turn film-coating technology will occur with the growth of the pharma industry. While growth in developed markets will slow down, emerging markets will become increasingly important in the coming decade. The Indian pharma market which is expected to expand at a CAGR of 12.89 per cent over 2015–20 to reach $ 55 billion, along with the markets of China, Brazil and Russia will spearhead growth within these markets,” said Pareek. Constant rise in stress and lifestyle related diseases among Indian population will drive the need for innovation and research, bringing novel drug delivery systems to the market. This will in turn drive the need for innovative coating formulations. With increasing awareness of health insurance and better availability and affordability of drugs, the pharma industry is enroute exponential growth. With the government slowly increasing investment in healthcare under the National Health Policy and trying to reduce the time

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for approval of new facilities, we can expect the pharma and in tun, the excipient industry to grow. Continuous innovation in the field of manufacturing – the process and the equipment allows for continuous innovation in coating formulation. From coating of just tablets, the industry now requires technology for coating other delivery systems such as catheters, stents, ingestible imaging instruments, joint plates etc. With the advent of such technologies, film coating will continue to grow hand-in-hand. However, such technologies require intricate coating techniques and will need to keep patient safety at the forefront. Drugs are required to be released at very specific intervals, imaging instruments must be delivered within the body without harm to the patient. Such requirements drive the film coating industry to bring about advanced and novel innovations, encourage research and ultimately bring about growth. “With multiple R&D centres, application laboratories, new manufacturing facility and offices in the US, Israel, Italy, Spain, Turkey and distributor channels globally, Ideal Cures has immersed itself in bringing novel filmcoating innovations to the market. They are continuously engaged in process and product improvement and does not restrict only to filmcoating but have also diversified into other excipients such as acrylic polymers, cooling compounds, inert spheres and others,” said Pareek. “Film coating is well established in solid dosage form that offers many advantages for pharma products. There are a number of manufacturers manufacturing coating equipment globally and can be procured with not much difficulty. Coating process time is much less as compared to sugar coating. Coating pre mix manufacturers provide support in training

beside trained manpower is also available. These growth drivers are similar to other markets globally,” said Arora.

Pros and cons Earlier sugar coating was mostly applied to tablets using conventional coating pan. It was a time consuming process, which used to take four to five shifts, besides use of skilled manpower. Now film coating has taken over sugar coating and we see very few products which are sugar coated. Additionally, use of perforated coated pans/ fluidised bed coating processor in film coating has reduced coating time significantly. Film coating minimises the risks of medication errors leveraging pigments / colours for identification and also improves patient compliance through aesthetic appeal. Jain said that there are certain disadvantages of film coating. These disadvantages limit adoption of newer equipment due to Expensive equipment & plant requires large space, High installation and energy costs. With the increasing potency and sensitivity of APIs, there is a constant need for inert materials that, as well as avoiding incompatibility issues, also protect drugs from degradation caused by environmental factors, such as moisture, light, heat and oxygen. However, designing such a material will be a challenge for the industry. Getting rid of organic solvents remains a topic of interest and getting rid of any solvent with dry coating could also be part of the future. Pareek says, “As new technologies emerge, there is reluctance in their acceptance because of the time and energy needed to be spent in filing changes with the FDA. However, with new regulatory changes and the FDA encouraging continuous operations, this challenge will slowly be eliminated. Some countries around the world still use traditional methods for drying of tablets during

coating operations. This continuation in use of organic solvent based coating limits the acceptance of aqueousbased systems that are much more capable of bringing about increased productivity. Reluctance in use of new technology and improvements in manufacturing process and switching over from old methods is a major challenge that limits the use of evolving film-coating technology. “I am sure with right kind of guidance and technical support we can bring the much needed change in these traditional practices,” he said. “Going forward, I see the pharma industry adopt continuous manufacturing and in some cases solvent free coating for which a lot of work is going on in different countries with respect to production equipment etc. There would be changes in manufacturing equipment and also in coating pre mixes”, says Arora. “As new technologies emerge, there is reluctance in their acceptance because of the time and energy needed to be spent in filing changes with the FDA. However, with new regulatory changes and the FDA encouraging continuous operations, this challenge will slowly be eliminated,” Pareek said. Some countries around the world still use traditional methods for drying tablets during coating operations. This continuation in use of organic solvent-based coating limits the acceptance of aqueous-based systems that are much more capable of bringing about increased productivity. Reluctance in use of new technology and improvement in manufacturing process and switching over from old methods is a major challenge that limits the use of evolving film-coating technology. With the right kind of guidance and technical support, much needed change in these traditional practices can be brought. swati.rana@expressindia.com

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August 16-31, 2017

PHARMA ALLY I N T E R V I E W

IEC plans to develop SOPs for standard ICCCS courses Koos Agricola, Chairman, Cleanroom Testing and Certification Board – International (CTCB- I) and Sant Advani, Secretary, Contamination Control Society of India (CCSI) in an interaction with Usha Sharma, talk about their new programmes for the Indian market

What are the core objectives of International Confederation of Contamination Control Societies (ICCCS) and how does it function? Koos Agricola (KA): The ICCCS is a platform for national societies to exchange knowledge and information on cleanroom technology and contamination control. There are three fields in which this is done: development of standards, organising symposia and education. In 2016, ICCCS reorganised itself in order to function better in these fields. The executive board has set up committees on education, standards, events, members and communication. The goal is to create more value for ICCCS members. The ICCCS members meet once in a year. These meetings are combined with the ISO TC209 meetings. In 2018, the meeting will be held in The Netherlands. Are there any plans to incorporate new courses for India? KA: The ICCCS Education Committee has worked as a separate organisation called ICEB (International Cleanroom Education Board) in the past. They developed an accreditation programme for international courses by ICCCS members. This

62 EXPRESS PHARMA August 16-31, 2017

programme will be continued and extended. The International Education Committee (IEC) plans to develop Standard Operating Procedures (SOPs) for standard ICCCS courses. The first ICCCS course is the Cleanroom Behaviour or Cleanroom Pass course. This course can be conducted by members in their own languages using the IEC SOP’s. They can issue an ICCCS Cleanroom Pass stating that the bearer knows the basics of cleanrooms and understand the entry and behaviour procedures. This is good for manufacturing companies for their employees, but especially for services companies.

The ICCCS members meet once in a year. These meetings are combined with the ISO TC209 meetings KOOS AGRICOLA, Chairman, Cleanroom Testing and Certification Board – International (CTCB- I)

Till now, how many Indian pharma companies have trained professionals in cleanroom technology and what is their progress report? Sant Advani (SA): Close to 20 major pharma companies have sent delegates to our certification courses held in Mumbai and Hyderabad. There were a total of 87 candidates for the two courses including representatives from cleanroom contractors and validators. It is too early to get a feedback from the participating companies as the first certification

programme was held only six months ago. I am confident that positive feedback will start flowing in shortly.

We are planning an advanced level course which will be launched in November 17 SANT ADVANI, Secretary, Contamination Control Society of India (CCSI)

How many such courses/programmes have you planned to introduce for the Indian market? Are these courses accredited by domestic / international body? SA: We have held two courses for the intermediate level Contamination Control personnel and plan to hold three more courses in Bengaluru, Goa and Ahmedabad. We are planning an advanced level course which will be launched in November 17. Both the courses are accredited by the ICCCS headquartered in Holland. The certificates issued to the successful candidates bear the logos of ICCCs and CCSI and are recognised internationally. What is the future for Indian pharma cleanroom market? SA: The Indian pharma industry is set to grow exponentially due to rising international demand and domestically the government’s push to the healthcare sector is very positive. CCSI with its training initiatives hopes to contribute to the success. u.sharma@expressindia.com

PHARMA ALLY VENDOR NEWS

Corning, Gerresheimer collaborate

Shimadzu launches new Nexis GC The launch of this new product is in line with its focus on continuous innovation and introduction of market leading technologies

SHIMADZU Corporation, Japan, has launched the Next Industry Standard Gas Chromatograph - Nexis GC-2030 - in the Indian market, as part of its global launch. Shimadzu launched its first gas chromatograph over 60 years ago and today is one of the world’s fastest growing chromatography companies. The launch of this new product is in line with its focus on continuous innovation and introduction of market leading technologies. Toshvin Analytical, authorised distributor of Shimadzu Analytical instruments in India since 1970, organised a series of product launch seminars in Ahmedabad, Bengaluru and Mumbai, which were attended by over 450 customers. Manoj Kantak, Executive

Director, Toshvin Analytical, Yoshiyuki Fujino, MD, Shimadzu Analytical India and Takaaki Hiraoka, Product Manager, Shimadzu Japan were present to grace the event. Gas chromatographs are used for R&D and quality control in a wide range of fields, such as petrochemicals, fine chemicals, environmental testing, pharmaceuticals, food products, electronics/semiconductors, and flavourings. With the growing concern about safety and to minimise any impact on both humans and the environment, there is increasing demand for analysing trace impurities in raw materials and analysing the gases emitted from products. The Nexis GC-2030 has

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been designed based on the concept of superior usability and expandability for accommodating a wide variety of applications. The new user interface features a full-colour LCD touch panel that provides intuitive and easy-to-understand operability. The included software allows access of laboratory instruments from a smartphone or tablet computer, which enables remote instrument monitoring regardless of the operating environment. In addition, the maintenance required for Nexis GC is significantly reduced through the unique 'ClickTek' technology where no tools are required to open and close the sample injection port, attach and detach columns, or exchange split lines.

To accommodate a wide variety of analytical applications, the Nexis GC-2030 can be equipped with any of a family of high-sensitivity detectors, such as the barrier discharge ionisation detector (BID) or a flame ionisation detector (FID) that offers the world’s highest sensitivity. In addition to the high reproducibility achieved by the new flow controller, it provides automatic gas leak check and self-diagnostic functions that ensure high reliability. Further, Nexis GC 2030 has Improved compatibility with specialised analysers (System GCs) tailored to user needs which help reduce costs and space requirements, and increase analysis productivity.

CORNING Incorporated and Gerresheimer announce that they are accelerating the supply of Corning Valor Glass to the pharmaceutical industry. Valor Glass is a breakthrough glass container engineered for the storage and delivery of 21st century injectable drugs. Valor Glass is an unprecedented improvement in glass container quality. Valor Glass’s superior strength, chemical durability and damage resistance result in better protection for drug products. Valor Glass also enables increased throughput and higher levels of quality assurance for pharmaceutical companies, and higher-quality medicines for patients. Corning and Gerresheimer have been working together since 2015 to accelerate Corning innovations for the pharmaceutical glass packaging market. “We are thrilled to be working with Corning on innovations to enhance quality across the industry. Valor Glass is a remarkable Type I glass with outstanding performance on every attribute,” said Uwe Röhrhoff, CEO, Gerresheimer. “Gerresheimer is a long-standing leader in the industry. They’ve been a terrific collaboration partner, and we’re excited to be working with them to bring Valor Glass to the pharmaceutical industry,” said Ron Verkleeren, VP and GM, Corning Pharmaceutical Technologies. EP News Bureau

EP News Bureau

EXPRESS PHARMA

August 16-31, 2017

PHARMA ALLY PRODUCTS

Gandhi Automations clean room high speed doors, an integral part of pharma manufacturing facilities NUMEROUS manufacturing facilities now require a controlled environment in which the amount of dust and dirt in the area of the manufacturing can be limited. 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 an integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms are the doors needed for cleanroom facility. Time for which door is

speed doors are best suited for facilities where controlled environment is needed. The opening and closing of door is quick enough to separate outside environment and internal facility.

open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to be quick enough to isolate the outside en-

vironment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high

High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows

◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website : www.geapl.co.in

Newtronic launches orbital shaking incubators SHAKING INCUBATORS, also known as environmental shakers, are often used for cell culturing, cell aeration and solubility studies. In addition to stable temperature conditions, they use an orbital agitation at variable speeds to affect the growth of cell cultures. Newtronic shaking incubators have adjustable speed and orbit to meet each application. Models can be equipped with a universal shaking platform, or fixed flasks. Independent alarms and PLC-based controls for temperature and speed adjustment with touch

screen display are also present. Applications include: Cell cultures, cell aeration, microbiology, increasing solubility rates, metabolism studies, bacterial cultures, and bacteriology. Newtronic delivers all the features and bench top model shaking incubators, with even greater load capacity. The unit performs from 50-300 RPMs with a smooth, quiet oscillation. The door of the larger model is designed with hydraulic pistons making it easy to lift during loading and un-

loading. CFC free cooling system consisting of hermitically sealed compressor couple with evaporation coil and condenser.

Salient features ◗ Inner and outer Chamber S.S. 304 ◗ Variable speed from 50 RPM to 300 RPM ◗ Touch screen display ◗ Shaking amplitude 25 mm ◗ Universal platform to accommodate interchangeable molded clamps of assorted sizes for different capacity of asks. 100 ml ,250ml,500ml

◗ Automatic restart at preset speed in case of power failure ◗ PLC-based temperature controller

Optional accessories ◗ Chamber illumination with fluorescent light

◗ Cyclic timer for illumination control Contact details 108-ABCD, Kandivali Co-op. Ind Estate Charkop, Kandivali (West) Mumbai – 400067 India T: +91 -22- 2867 9326

Models

Chamber Volume (Litres)

Platform Size mm

Internal Dimensions H x W x D mm

External Dimensions H x W x D mm

Temperatur Range (Accuracy)

NLOS90R

330 x 330 (7.5kg)

450 x 450 x 450

620 x 870 x 7100

5ºC to 60º C (+- 1c)

NL-OS 270R

270

745 x 490(15kg)

450 x 900 x 670

700 x 1380 x 1020

64 EXPRESS PHARMA August 16-31, 2017

PHARMA ALLY

Anchrom launches high performance thin layer chromatography THIN LAYER Chromatography is by far the most popular chromatography technique for qualitative and semi-quantitative analysis, since the 1960s! Over the years, TLC started to be performed instrumentally, overcoming some of the limitations, such as sample application as bands instead of spots, quantitative evaluation by densitometry etc. However no SOP for HPTLC was ever established. This led to confusion between TLC and HPTLC, which led to instrumental TLC being wrongly called as HPTLC. TLC is a manual method that uses devices designed in the 1960s and its methods cannot meet cGLP and other modern regulatory requirements. Instrumental TLC requires TLC software and instrumentation for sample application, chromatogram development, evaluation by scanner, chromatogram “image” visualisation and documentation all controlled by one software. However, the SOP is still missing. HPTLC requires the above instrumentation plus control of all parameters that affect chromatography, which is where the USP SOP comes into play. The moment of truth came on August 1, 2015 when USP Chapter 203 became effective. PhEur has adopted exactly the same SOP albeit in different words, in 2017. Both TLC and HPTLC are pharmacopoeial procedures; however, the following table shows the parameters that are required to be controlled in the two. Column chromatography is to HPLC what TLC is to HPTLC. No procedure can become a regulatory method in trillion dollar trades unless numerous experts and authorities are

HPTLC (USP SOP)

TLC

Software controlled chromatograph

No s/w or h/w

All parameters influencing results are controlled

Development in equilibrated chamber

Plate size - 20x10 cm

Plate size - 20x20 cm

Plate support materials – Glass,Al

Support materials – Glass,Al

Silica gel F254 (5 μm particles)

Silica gel F254 (10-30μm)

Layer activity (~33%RH) (Mgl2 sat.soln.)

No control

Sample band – 8x1 mm

Spot diameter – 2-10 mm

Sample position – 8 mm from bottom

– 15mm

Distance from side edge – 20 mm

N.A

Drying time - 5 min

variable

Max.no. of tracks per plate - 15

Max 12

Twin through chamber

Beaker or Flat or twin trough

Paper lining of chamber – A must

Usually no

Chamber saturation time – 20 min

Saturation time – 1-2 hrs

Development distance – upto 70 mm

Development – upto 150 mm

REGULATORY COMPLIANCE

21 CFR 11 compliance

IQ – OQ – PQ

System Suitability Test

cGLP compliance

Electronic device for recording images under cGLP

Intensity markers

satisfied about the quality of results. The main drawback of in-

To subscribe: bpd.subscription@expressindia.com

strumental TLC i.e. chromatographic development done in non-standardised

manner in an open system has been completely eliminated by the development of an auto-

mated development chamber, in HPTLC HPTLC must not be looked through LC eyes. They are two separate techniques, each with its own strengths and limitations. Generally speaking LC scores in a technical sense while HPTLC scores in practical sense. Limitations of HPTLC include short separation bed (62 mm effective length), limited number of samples per plate, presence of silica gel during detection (unless MS is the detector). However the advantages are too numerous, which are evident to an open and scientific mind. HPTLC is the fastest chromatography method; result is visible both to detector and human eye (!), analyses 5060 samples of 5-6 different types in parallel, has very low cost of analysis, negligible maintenance and a log machine life. HPTLC is shareable since it is not dedicated to any sample. Multiple detection modes like UV, Visible, Fluorescence, Bio-assay, MS, post-chromatographic derivatisation etc. can be used without repeating chromatography. Sample cannot contaminate chromatograph. Cross contamination is impossible. Samples and standards are chromtographed in identical conditions. HPTLC instrument can be share. No set-up time. Hyphenation with MS can produce several dozen MS per day. These are but a few advantages. HPTLC is the ideal method for first opinion on any organic, non-volatile sample. Contact details Anchrom Enterprises (I) 101, A Wing, Aniket Apartment, Navghar Road, Mulund (E), Mumbai - 400 081, India. Tel.: 091 22 21639928 31/7506792122 Fax: 091 22 21639927 E-mail : hptlc@anchrom.in Web : www.anchrom.in

EXPRESS PHARMA

August 16-31, 2017

PHARMA ALLY

Virosil Pharma: ASwiss eco-friendly disinfectant SANOSIL BIOTECH, a Mumbai-based company is the first company to pioneer the novel concept of ecofriendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine based disinfectants have been feared. Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, Ranbaxy, J&J, Abbott, Serum Institute, Dr Reddy’s, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, Reliance Life Sciences, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Virosil Pharma effectively protects critical surfaces that come in contact with pharma products. Manufacturing, filling, packing and storage areas; Instruments, equipment, water tanks and pipelines – can now be pathogen free. What’s more, there’s no need to re-wash disinfected surfaces or instruments since H2O2-based Virosil Pharma safely decomposes into water and oxygen. The formulation has been tested in various reputed institutions in Switzerland, France, Germany, Australia and India.

MIC determination Method Based on modified BSEN13704 (sporicidal) Test Organisms: 1) Bacillus subtilis ATCC 6633

66 EXPRESS PHARMA August 16-31, 2017

Disinfecting biofilms using Virosil Pharma Virosil Pharma not only successfully penetrates bio-films and eliminates bacteria but also maintains a long residual level of disinfection in water tanks and pipelines. Using Virosil Pharma overcomes the disruption problem because it is absolutely safe to leave it in the water. Better still, the longer it’s in the water, the better the results since it will attack the biofilms which harbour most of the bacteria populations. The company also offers a customised disinfection audit on its website; www.sanosilbiotech.com

RESULTS TABLE 1- COUNT OF STANDARD CULTURE B SUBTILIS USED Standard Culture

CFU/ml

Log Value

B subtilis

270000000

8.4313

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

Microbial Counts in Log Values

Log Reductions

Virosil l0% Virosil l0% Virosil l0% Virosil l0%

B subtilis

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

4900

2300

310

4.7411

5.0696

5.9400

3.6901

3.36178

2.4913

99.9981

99.9991

99.9998

HOW EFFECTIVE IS IT?

HOW SAFE IS IT ?

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

It cannot pollute waste water, because it breaks down into water and oxygen, i.e. it produces no noxious byproducts

VIROSIL PHARMA For bacteria- free surface & Pipelines

HOW DOES IT COMPARE TO CHLORINE? Virosil Pharma is superior to chlorine since it imparts no taste or odour to the water and is highly effective at both hot and cold temperatures

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

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

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Wiper Type Sight Glass

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DIN 100 Light Glass LED

Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com

Our other product details u

SS Fittings

SS Valves Manual & Pneumatic

SS Filters

SS Pumps: Centrifugal, Self Priming & Shear Pump

SS Powder Blender

SS Steam & Water Mixing Station

Drain Trap

LED Bush

Sight Glass Flange with LED

4W / 15W / 20W / 24W

Manhole Round Dia 450

Manhole Pressure Type

Manhole Elliptical

WSDS (Western Static Dissipative Silicone/Sieves) ADVANTAGES

Food Safety ECC

All silicone rubber products suuplied by WPIPL comply with these regulations

Silicone Flange Gasket

Wsds (Western Static Dissipative Silicone/Sieves) 1. It is 100% food grade, FDA and ECC approved conductive silicone 2. It is bacteria free, bacteria will not deposit on the surface 3. Wsds can resist repeated sterilizing 4. It is fungus free 5. It is grey in colour 6. MSDS is completely safe

Viton O Ring Kit

Silicone Rubber Strip

Platinum cured silicone house

Corrugated round bellow

Peristaltic pump tubing

Silicone Tapered Plug

Tri clover gasket

Silicone Inflatable Seal for Fluid Bed Dryers

WESTERN POLYRUB INDIA PVT LTD C 12/13, Singh Industrial Estate No. 1, Ram Mandir Road, Goregaon (West), Mumbai - 400 104, India. Tel.: 91-22-26764144 / 26760203 / 66944301 / 66949199 l Mobile : 91-9833590390 / 91-9833508079 Website: www.westpolyrub.com l Email: info@westpolyrub.com

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Business Avenues Please Contact: ■

Mumbai: Rajesh Bhatkal 09821313017

■

Ahmedabad: Nirav Mistry 09586424033 ■

Delhi: Ambuj Kumar 09999070900

■

Chennai ■ Bangalore: Mathen Mathew 09840826366

■

Hyderabad: Mujahid 09849039936 ■

Kolkata: Ajanta 09831182580

NEW AS 200 BASIC, DIGIT CA & CONTROL Vibratory Sieve Shakers

Particle Size Analysis with EasySieve® Software and CFR 21 Compliance EasySieve, the software for particle size analyses, exceeds manual evaluation in many aspects. n Automatic registration, evaluation and administration of measurement data n Measurement protocol inaccordance with standards n EasySieve CFR offers compliance with FDA 21 CFR Part 11 P R E M I U M Q UA L I T Y MAD E IN GE R MANY

August 16-31, 2017

marketing@verder-scientific.co.in www.verder-scientific.co.in

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A BENCHMARK FOR

QUALITY SOLUTIONS

STABILITY CHAMBER

WALK-IN STABILITY CHAMBER

AUTOCLAVE-WINGNUT

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Factory: 112/B, Marudhar Indl. Estate, Opp. Old Syndicate Bank, Goddev Road, Bhayandar (E) - 401 105. Telefax: 022 28197355, Mobile: 91 9892414152 / 9820469764 Email: sari@mtnl.net.in / gaurav_rubber@rediffmail.com Website: www.gauravrubbers.net Representative for Solan / Baddi : Mr.Gurumurti. Tel- 09418308852

Autoclave BOD Incubator Bacteriological Incubator Cooling Incubator Deep Freezer Hot Air Oven

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Muffle Furnace Photo Stability Chamber Pharma Refrigerator Stability Chamber Vacuum Oven Walk-in Stability Chamber

Osworld Scientific Equipments Pvt. Ltd.

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B.O.D INCUBATOR

www. a. ldindi oswor com

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

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YOUR PARTNERS FOR STERILE FLUID TRANSFER

www.kesarcontrol.com

Humidity Chamber

Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India. Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: pharma@shahbros.com

www.shahbros.com

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Cold Chamber

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

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Goggles & Writing Accessories For Cleanroom

le ailab ch v A Now n Laun n lea Bioc g Versio o f i t An

Sterile Pen & Marker

S S Writing Pad & S S Pen With Chain

Cleanroom Vinyl Sterile Tape 1/2”, 1” & 2”

Clear view Autoclavable Panoramic Thermoplastic rubber Body Goggles With 40 Autoclave Cycles

Can Be Worn Over Eyeglass With Grid For Marking Autoclaving Goggles

BCAG

Cleaview Autoclavable Goggles With 40 Autoclave With Grid For Marking Autoclaving Goggles

11X14EPAd02

Cleanroom Paper & Pad (Autoclavable)

BCAP

Grid For Marking Autoclaving

Grid

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PHARMA LIFE APPOINTMENT

CPAappoints Dr Rao VSVVadlamudi as President Dr Vadlamudi is the second Indian professional to hold this post

r Rao VSV Vadlamudi, President of Indian Pharmaceutical Association (IPA), has been elected as President of Commonwealth Pharmacists Association (CPA) for the period 2017 – 19. Dr Rao Vadlamudi is the second Indian professional to be elected as CPA President after a gap of 30 years. The first CPA President from India was late Dr JN Banerjee during the period 1982 – 1987. The CPA is an organisation of Commonwealth professional pharma bodies and individual members with an objective to empowering pharmacists to improve health and well-being throughout the Commonwealth there by adding quality

to the range of services offered by the pharmacists with head quarter based at UK. Dr Rao Vadlamudi has been President of IPA, the national body of pharmaceutical professionals in India for the period 2014 – 18. During this period, he led the Association in organising successful international and national events including the 61st International Pharmaceutical Students’ Federation (IPSF) World Congress in 2015. During this period, he also initiated advocacy exercises with the Indian government, pushing forth policy inputs and documents, furthering the cause of pharmacists and pharmacy profession in the country. Under his tutelage, in December 2016,

Dr Rao Vadlamudi has been President of IPA, the national body of pharmaceutical professionals in India for the period 2014 – 18

IPA went on to organise the Indian Pharmaceutical Congress (IPC) that witnessed participation of over 10,000 national and international del-

egates from various facets of the profession. He has also partnered with organisations like FIP, FAPA and WHPA to tackle major health care issues including tackling Antimicrobial Resistance and Campaign against Drug Counterfeiting globally. An acade-

mician and a scientist, Dr Vadlamudi has also led cutting – edge drug discovery programmes in companies like Hoechst India (Sanofi) and Nektar Therapeutics India. EP News Bureau

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82 EXPRESS PHARMA August 16-31, 2017

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