Express Pharma (Vol.11, No.18) July 16-31, 2016 by Indian Express

VOL. 11 NO. 18 PAGES 96

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CONTENTS Vol.11 No.18 JULY 16-31, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap New Delhi Prathiba Raju

Getting future ready with automation Irrespective of a significant investment involved in it,the Indian pharma industry has no option but to embrace automation to achieve their global ambitions. By Sachin Jagdale | 40

MARKET

HEALTHCARE SENATE TO BE HELD IN HYDERABAD FROM SEPT 22-24

CONFERENCE ON DRUG COUNTERFEITING ORGANISED IN MUMBAI

MANAGEMENT

DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka

INTERVIEWS P20: KAREN FLYNN Senior Vice President and Chief Commercial Officer, West Pharmaceutical Services

Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar

P22: RAHUL DEV

Photo Editor Sandeep Patil

Vice President, Datwyler India

MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar Arun J Debnarayan Dutta E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager B R Tipnis

P24: AVPS CHAKRAVARTHI

BREXIT IMPACT: SHOULD THE INDIAN PHARMA INDUSTRY WORRY?

MAJOR PLAYERS IN TYPE II DIABETES SHIFTING FOCUS TO PRICING TO MAINTAIN MARKET SHARE

GSK’S VACCINE SET TO REVOLUTIONISE MENINGOCOCCAL DISEASE PREVENTION MARKET

Managing Director, Ecobliss

P26: PV NARAYANAN Chairman, SIES School of Packaging

P30: JAVIN BHINDE Managing and Chief Executive Officer, SynCore Consulting

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan

P46: AKSHAY CHAREGAONKAR

CIRCULATION Circulation Team Mohan Varadkar

Director, Anchrom Enterprises India

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. 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.

EDITOR’S NOTE

Back to the basics

fter taking a beating from overseas regulators for the past few years, analysts are finally sounding marginally cautious about the fortunes of pharma companies in India. The last fortnight has seen some marquee companies announce that they've been able to satisfactorily settle manufacturing issues red flagged by the US FDA during plant inspections. But will the learnings of the last year last? Only time will tell. A sector update from Motilal Oswal Securities Limited (MOSL) dated July 8 asks if the tide is turning, citing closure reports filed by Lupin, Cadila Healthcare and Alembic. But Lupin is only partially out of the woods. Though its July 2015 US FDA inspection is settled, the March 2016 closure report for nine 483s from the same plant is still pending. Similarly, Cadila Healthcare is still under a warning letter though 483s raised during inspections dating back to August and September 2014 are settled. Alembic's Kharkhadi plant is now in the clear but the four 483s from the Panelav facility are still pending. The fact that two other API facilities located at Panelav passed an inspection as recently as June this year without any 483s could mean that the past inspections have resulted in internal corrections, be it greater awareness among the staff as well as corrections in processes and investments in quality systems. Are we finally seeing some light at the end of the tunnel? It's still a long way off. The MOSL report shows that around 10 pharma companies from India await resolution of US FDA enforcements, dating back to February 2013. But maybe we've started to claw our way back and the

Will the learnings of the last year last? Only time will tell

tough times will translate into hard won insights. Just as pharma companies have had to examine their basic framework and correct flaws which had crept into their DNA, this slack period on the BSE Healthcare Index, after seven years of strong earnings, has forced analysts and investors to re-examine the fundamentals of pharma stocks. A report dated July 9 from JM Financial Institutional Securities Limited (JMFISL) highlights that the emphasis on sustainable earnings driver, robust base businesses, deep product pipelines and long-term R&D initiatives is fundamentally altering the return profile (both quantitative as well as qualitative for the sector). The sector is entering a new regime, posits the JMFISL report, where the high return ratios are firmly in the past. Pharma companies have exhausted all the quick fixes of in-licensing products, brand acquisitions and technology platforms, says the JMFISL report, even while most pharma CEOs are setting aside a higher percentage of their revenues for higher R&D spends. This might be bad news in terms of stock investments, but having covered the pharma beat for close to two decades, it is music to industry observers. Have pharma CEOs finally got the guts to take their eyes of the near term gains, tighten their belts, and invest in the long term? And more importantly, have they been able to convince their shareholders and investors, that it is time to look at a longer horizon?

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET PRE EVENTS

Healthcare Senate to be held in Hyderabad from Sept 22-24 The senate will see 500 plus hosted buyers, 5000 meetings, 100 plus exhibitors, 18 conference tracks and industry awards Healthcare Senate, the national private healthcare business summit, will be held in Hyderabad from September 22-24, which will be organised by The Indian Express Group and Express Healthcare. The event will see a largest gathering of India’s most influential healthcare practitioners; CEO/CFO/MDs of hospital chains, medical superintendents, hospitals owners and decision makers, owners of single specialty hospitals, owners of diagnostic and other healthcare centres, hospital administrators, HoD of medical and bio-medical departments, HoD of engineering and operations, medical directors, purchase

managers, healthcare consultants, project heads, bio-medical engineers, dealers and distributors, thought leaders, industry stalwarts and domain experts. The senate will see 500 plus hosted buyers, 5000 meetings, 100 plus exhibitors, 18 conference tracks, industry awards etc. The three-day event will encompass learning (expert speakers, panel discussions, case studies and power discussions), a technology showcase featuring leading providers, the Express Healthcare Excellence Awards in the private sector, and prefixed peer to peer networking and relationship build-

ing (gala dinners, excursions and entertainment), all of which are part of this prestigious forum. The topics which will be covered at the senate are ‘Sustainable Healthcare Delivery Models for the future,’ ‘Balancing profitability with responsibility’, ‘Raising capital for healthcare’, ‘Dealing with cost burden of medico legal tangles,’

‘Protecting brand image: How intangibles impact the bottomlines,’ ‘Managing human capital in the healthcare sector,’ ‘Investing in Quality: Best practices, accreditation, infection control, procurement,’ ‘How patients are driving innovation in business models.’ To be held concurrently with Healthcare Senate on September 23, 2016, Express

Healthcare Excellence Awards will celebrate the spirit of excellence and leadership in healthcare delivery in the private sector. The awards will recognise private hospitals and industry leaders for their vital contributions to healthcare in India. The awards seek to honour the pathfinders, innovators and game changers from within the private healthcare industry. The Association partners for the event are Karnataka Imaging Education Foundation, Consortium of Accredited Healthcare Organisations and Association of Healthcare Providers India. EP News Bureau-Mumbai

Hyderabad to host PharmaLytica 2016 The third edition of the international trade fair and conference will be held at HITEX Exhibition Centre PHARMALYTICA 2016 will be held at the HITEX Exhibition Centre in Hyderabad on August 5 and 6, 2016 . In the third edition of this international trade fair and conference, the pharmaceutical community can pick up on the latest industry trends, innovations and do business with analytical, Bio tech, Lab, Pharma Machinery and Outsourcing services.

10 EXPRESS PHARMA July 16-31, 2016

The industry focused conference will focus on latest pharma market insights, in-depth case studies, and exceptional networking opportunities PharmaLytica conference, collocated with the exhibition is the knowledge forum and

important industry gathering that will bring an entire range of topics in analytical, out-

sourcing, laboratory, scientific and biotechnology sector. PharmaLytica is evolving as the leading marketplace for products and services along the entire value chain in niche segments within the pharma industry. Visitors will be able to explore new business opportunities and expand the network, meet pharma professionals and build partnerships. Visi-

tors profile include, analytical development heads, outsourcing department heads, R&D heads, clinical trials and research associates, laboratory heads / technicians, quality control and quality assurance heads, formulations development, business development heads and production and purchase heads. EP News Bureau-Mumbai

MARKET POST EVENT

Conference on drug counterfeiting organised in Mumbai PatientSafe India addresses various aspects of drug counterfeiting and suggested creative ways to raise awareness and devise strategies to curb the practice Usha Sharma Mumbai

ynCore Consulting, in collaboration with Organisation of Pharmaceutical Producers of India (OPPI), AIOCD, Indian Medical Association (IMA), Indian Pharmaceutical Association (IPA), Indian Drug Manufacturers’ Association (IDMA), Maharashtra FDA, trade bodies and consumer groups, recently organised PatientSafe India, a day-long conference on Drug Counterfeit Challenge in Mumbai. The conference addressed various aspects of drug counterfeiting and suggested creative ways to raise awareness and devise strategies to curb the practice of drug counterfeiting. Sudarshan Jain, Vice President, OPPI and Managing Director, Healthcare Solutions, Abbott Healthcare delivered the inaugural speech. Omprakash Sadhwani- Joint Commissioner (HQ), Drugs Controller of Maharashtra, Food and Drugs Administration, Mumbai gave the keynote address while the special address was given by Dr K Bangarurajan, Deputy Drugs Drugs Controller (India). The first panel discussion on 'Collaboration among all stakeholders – key to combat counterfeiting' was moderated by Vivek Padgaonkar, DirectorProject and Policy, OPPI. Daara Patel – Secretary General, IDMA, in his session, emphasised about the work being done by IDMA. He recommended that if regulators, medical representatives, quality control stockists etc., work together, then the challenge of counterfeiting can be overcome.

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Dr Jayesh Lele, President, IMA (Maharashtra) informed that the doctor fraternity is not aware about the work being carried out by pharma companies to improve the quality of medicines. He suggested that with the help of continuing medical education (CMEs) etc., pharma companies can educate doctors about spurious/ fake medicines. Pointing out the possibility

of increase in the number of counterfeit drugs through ecommerce channels, Vaijanath Jagushte, Treasurer, Maharashtra State Chemists and Druggists Association expressed his concerns about online pharmacies and the threat posed by them on patient safety. Today, there are more than 250 e-pharmacy sites and the numbers are going to increase.

Presenting the global perspective, Ajit Singh, Chairman, ACG Worldwide, informed that according to the World Health Organisation (WHO), 30 per cent of medicines across the globe are counterfeit. European Commission refers to them as falsified medicines instead of counterfeit drugs. Counterfeit/falsified medicines are available across the world. The US

FDA website has mentioned the actions being taken against USbased companies for not following regulatory standards. Hence, the issue does not only pertain to Indian companies, but also companies spread across the globe. Besides, he also discussed about modern printing technologies in packaging and their contribution in today’s world. Dr Rao VSV Vadlamudi, President, IPA, shared details of the work being carried out by the association to educate patients. He said that IPA is trying to create an awareness among the patients and working with various regulators, patients, supply chain, besides providing education materials etc. The association has also prepared a model to fight against spurious/counterfeit medicines. Referring to Sadhwani's message, he said that patients or caregivers need to reject counterfeit products and this can only happen if they are well informed/educated about counterfeits. Patel, while discussing about the solutions to handle counterfeiting, said that we need to have strict protocols in place to choose the right packaging materials. Bejon Misra, Founder and Partnership for Safe Medicines (PSM) India, talking on the sidelines of 'Success Stories on patient safety, informed about the role of the supply chain while delivering safe medicines to the patients. He also mentioned that the solution is to work in participation and not in an isolation. Kairus Dadachanji, Managing Director, Schott Kaisha, elaborated on the solutions pro-

MARKET vided by Schott Kaisha to its customers. Sanjiv Navangul, Vice President, OPPI and Managing Director, Janssen India, stressed on the point that training regulators, medical representatives, quality control stockists etc should be our primary focus rather than educating the patients. It is our responsibility to make them informed and vigilant, he emphasised. The second panel discussion was on 'Redesigning drug manufacturing and its supply chain process to make it less vulnerable to counterfeiting.' The panelists were Deepshikha Jakate, Site Quality Head, GSK; SM Mudda, Director Global Strategy (Technical) Micro Labs, Dr Firdosh Gardin, Head External Supply Operations, India Cluster, Novartis India; Sadhana Mogre, Director External Manufacturing, Sanofi India and Ameesh

Masurekar, Director, AIOCD Pharmasofttech AWACS. According to Javin Bhinde, Managing Director, SynCore Consulting, drug counterfeiting is one of the classic cases wherein the source of disruption lies way out of the area of influence of the manufacturer but there is a lot that manufacturers can do to dramatically limit the

ability of drug counterfeiters to breach the boundaries of the legitimate supply chain. More often than not, traditional supply chain designs offered many fundamental barriers to the flow of information to and from various touch points across the value chain. This combined with the intricate and highly complex nature of the

downstream flow of materials made it a formidable task to have a real-time understanding of what was transpiring. Information and its rapid availability can be a key lever in addressing the counterfeiting challenge. In many cases, the very guiding principle of supply chain design. Traditional push-based

supply chains attempted to address the slow and cumbersome flow of information back upstream from the markets by adopting a 'High service level' policy which dictated manufacturing and shipping substantial excess inventory maintained at various points across the supply chain. Not only does this put a severe strain on company profitability and increase business risk, but the added problem is that it substantially increases the slack in the system which increases the policing effort, delays detection and hinders visibility. The conference also discussed topics like 'fostering innovation in anti-counterfeiting management' and 'from brand protection to patient adherence'. Express Pharma was the media partner for the event. u.sharma@expressindia.com

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EVENT BRIEF AUGUST TO NOVEMBER-2016 5

PharmaLytica 2016

PHARMALYTICA 2016 Date: August 5-6, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: The third edition of PharmaLytica 2016 will see the pharma community pick up on the latest industry trends, innovations and do business with analytical, bio tech, lab, pharma machinery and outsourcing services. PharmaLytica conference, colocated with the exhibition will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector. The event is likely to witness 150+ leading local, regional, and international exhibitors, with 4500 expected visitors. It will be an industry focused conference with latest pharma market insights, indepth case studies, and exceptional networking opportunities. Both the events are supported by Ministry of Science & Technology, Govt of India Contact UBM India Times Square

PharmaTech Expo 2016

Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax +91 22 61727273

PHARMATECH EXPO 2016 Date: August 21-23, 2016 Venue: Ahmedabad Summary: The fourth Edition of 'PharmaTech Expo 2016, a PharmaTechnologyIndex.com venture will organise a pharma expo. The expo will be concurrently held with 'Pack & PrinTech Expo' and introduction of 'PIC India Expo.' It will focus on pharma ingredients and chemicals, giving a large scale exposure to pharma machinery, pharma ingredients and chemicals, packaging, printing, lab and analytical equipment etc. More than 150 exhibitors are likely to participate in the event. A special pavilion has been created for 'Track & Trace and Vision Inspection Equipment' to focus on the superior technologies

2nd Edition of Asia Labex

Analytica Anacon India and IndiaLab Expo 2016

available in India and the major industry players involved.

consumables. The exhibition will be organised by Fenza Exhibitons.

Contact Aarjav Shah PharmaTechnologyIndex.com (A Division of KNS Group) Tel: +91 – 79 – 27540493 / +91 – 79 – 40306340, 879616665 E-mail: expo@pharmatechnologyinde x.com / events@knsmedia.com Web: www.PharmaTechExpo. com/ www.PackPrinTechExpo. com / www.SwarnimVision.com

Contact Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

2ND EDITION OF ASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotech, research and testing instruments and

ANALYTICA ANACON INDIA AND INDIALAB EXPO 2016 Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest trade fair for the analysis, laboratory-technology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent. At the analytica Anacon India and India Lab Expo Conference, scientists from around the world will present their innovative analysis

CPhI and P-MEC India

solutions. Contact Email: info@analyticaindia.com

CPHI AND P-MEC INDIA Date: November 21 – 23, 2016 Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the latest trends and innovations the market has to offer. CPhI India is also co-located with PMEC India, the pharma machinery show in Asia. This year, the expo has grown from a three day exhibition to a show spanning a week, Pharma Week, (November 17 to 23, 2016). The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and recognition in the field of pharma. With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI & P-MEC 2016 will include exhibitor showcase, innovation gallery, speed meetings, live entertainment and much more. Contact details UBM India TIMES SQUARE Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

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cover )

DGFTâ&#x20AC;&#x2122;s track and trace initiative has spurred solution providers to come up with innovative labelling options to cope with regulatory requirements By Usha Sharma

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(

t is now more than five years after the Directorate General of Foreign Trade’s (DGFT) January 2011 announcement that all drugs and pharmaceutical products exported from India would need to incorporate track and trace systems. The roll out of the initial two phases, at the tertiary and secondary packaging levels did have its glitches but most companies are more or less in line with the mandate. However, manufacturers realised that 2D barcoding in the third phase, at the primary packaging line, presents a different level of challenge. The primary packaging line consists of containers like bottles, vials, ampoules and blisters, which are in direct contact with the drug, unlike the boxes and cartons at the previous two levels. The information to be printed on the labels on individual products, be they bottles, vials, ampoules, or blister strips, has to be readable but expiry dates, batch numbers, unique serial numbers, etc could lose their readability on certain products like medicine strips, vials, single therapy kits etc. As Siddhant Bhambhani, Product Management, ACG Inspection Systems explains, each primary packaging product type (bottles, vials, ampoules, blisters) presents unique labelling challenges. “The first product type, bottles are the easiest as “thermal transfer printers can be installed on the labelling lines for printing, and coordinated with labellers for product rejection. The challenge is to aggregate them with secondary

serial numbers, as the 2D code is present on the circumference of the bottle. Advanced camera systems are already available in the market to pick the 2D code by scanning the bottle 360 degrees,” he says. The second product type, vial/ampoule, are challenging due to their small size and the high speed of the packaging lines. He suggests that laser engraving is the only way to print 2D bar code on vials/ampoules or their labels. “This is difficult but possible. However, the need for serialising vials/ampoules is limited as these products are packed into cartons, which are the saleable unit.” Blisters, says Bhambhani, are the most challenging of the lot as till date there is no proven method to serialise blisters on live production lines. “In general, printing of text/logo on blisters is done on the lidding foil with the use of UV flexo printers. The challenge in printing 2D code on blisters is the knurling effect of the foil. Knurling of the foil on blaster machines is unavoidable, and this would distort the quality of the print. This would lead to high rejection percentage. The other solution is packing blisters in mono cartons and then printing 2D bar codes on it.”

Converting challenges into opportunities As the saying goes, necessity is the mother of invention. Bhambhani points out that when the government started with the track and trace initiative, they were not ready to print on the products at such fast printing speeds. But in re-

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Future of the innovative pharma labelling is bright and offers integrity for conceptualisation Kairus S Dadachanji Managing Director, Schott Kaisha

In general, printing of text/ logo on blisters is done on the lidding foil with the use of UV flexo printers. The challenge in printing 2D code on blisters is the knurling effect of the foil Siddhant Bhambhani Product Management, ACG Inspection Systems

THE MAIN FOCUS

sponse to the new regulatory requirement, industry leaders put in more efforts into creating the technology to meet client requirements. Innovation in labels for instance could address many regulatory needs. As Karan Kapur, Director, JK Labels explains, “Labels can fulfil all needs of regulations, innovations, high speed application, security, differentiation of product in a very economical way unlike (other) primary packaging components.” In a highly regulated sector like pharma, every component needs to meet standards and not every company can achieve the high benchmarks required by this sector. Thus though the size of the pharma labelling market has consistently grown at a healthy15-20 per cent per annum, according to Kapur, there are not more than 10 label printers in India who follow all regulations of pharma companies. This for instance requires GMP compliance, adherance to SOPs, installing plant and machinery to meet the standards of the pharma industry, including the latest inspection machines to check for text variation in labels. “It is extremely difficult for any label printing company to get audited by a large pharma company without having the right QA/QC systems since they are very particular which they should be,” says Kapur. Thus regulatory pressures have ensured that only the very quality conscious solution providers choose to serve the pharma sector.

Up the learning curve Kairus S Dadachanji, Manag-

ing Director, SCHOTT KAISHA, agrees that implementing 2D bar coding on primary packaging lines is a difficult task, indicating that implementing primary barcoding in India is still at an early stage, where certain authentication features need to be added. He also opined that this may be also due to cost concerns and confusion over GS1 standards. He also quotes data from PharmaSecure, a company offering solutions to protect medicines against counterfeits, which states that difficulties arise while achieving 100 per cent reading rates of codes on primary packaging using standard process. On a more positive note, Samit Yadav, Vice President Operations and Technology, PharmaSecure, puts these challenges as down to the initial phases of a learning curve. “Introduction of any new feature on product packaging initially has a learning curve. As the experience of brand owners and manufacturers grows in this field, implementation efficiency increases. Currently, there may be some challenges in direct printing related to the packaging line speeds, the compatibility of inks with substrates or the physical dimension of the primary packaging. Given the current scale and technological advances, there is enough opportunity for the industry to provide viable solutions,” explains Yadav. The importance of labelling in the pharma sector cannot be overemphasised. Labels are the sometimes the only link between a manufacturer and the external world (the retailer/stockist and the

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cover ) Currently, there may be some challenges in direct printing related to the packaging line speeds, the compatibility of inks with substrates or the physical dimension of the primary packaging. Given the current scale and technological advances, there is enough opportunity for the industry to provide viable solutions Samit Yadav Vice President - Operations and Technology at PharmaSecure

Labels can fulfil all your needs of regulations, innovations, high speed application, security, differentiation of product in a very economical way unlike (other) primary packaging components Karan Kapur Director, JK Labels

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July 16-31, 2016

consumer), providing vital information of the product, like expiry dates, batch numbers /lot numbers, unique serial numbers etc. Besides, it also provides information to patients about the product and acts like a bridge between the manufacturers and consumers. The nature of the product creates the challenge. As Kapur explains, “Vials and ampoules require labels that meet their low mandrel performance i.e. performance of a label around a small diameter. Hence, they require less GSM paper which cause less edge lifts and more commonly now PP/PE labelling. Also, since they are bottled at very high speed, a filmbased substrate is always suitable which does not tear. Regarding 2D barcoding on ampoule labels, the trend is yet to catch on and very few companies have currently adopted this.” The trend in the country, according to Yadav, is that bottles and vials of medicines have labels affixed and the technology can be extended to affix pre-printed (advanced) labels. “The existing labels will need minor artwork changes to create space for the 2D data matrix. This involves no changes in the existing processes at the packaging lines. Label converters will have to invest in printing variable 2D barcodes. This is a fairly a well known technology and is governed by a mature set of standards.” But globally, there have been some labelling innovations. As Dadachanji divulges, advanced labeling becomes an alternate solution for 2D barcoding and countries like the US, France, and Australia are already using these alternatives. These allow better identity (of the product and organisation), while meeting all regulatory requirements. Advanced labelling has still to catch on in India as it is at a relatively nascent stage. However, will adopting such methodologies ensure

authenticity and maintain brand identity in the market? According to Bhambhani of ACG Inspection Systems, “As of now, most of the alternative solutions that are currently available, require a decent amount of space. For example, RFIDs. If we go in for the smaller size RFIDs, they become extremely costly and are not feasible for use. The only way currently to incorporate a 2D barcode at the current lines speeds is to engrave the barcodes onto the glass using lasers. CIJ printers can also be used, however, the quality of the print and the speed at which it functions does not meet the requirements of majority of the ampoule vial lines in India.” Though there were considerable delays in implementing the various phases of

the track and trace initiative, none in the industry today dispute the benefits of the system. Dadachanji avers that incorporating 2D barcodes on labelling will ensure efficiency of products and maintain the brand identity in the market. Enabling track and trace mechanisms at the primary, secondary and tertiary levels of packaging for all export products will also safeguard from drug counterfeiters as the alpha numeric digit encoded in 2D barcode on label will ensure the identity of the manufacturers. Yadav agrees, saying, “2D data matrix coupled with track and trace technology are a worldwide accepted approach to identify leakage in supply chains. The 2D data matrix can be used by various stakeholders in the sup-

CHALLENGES OF IMPLEMENTING 2D BAR CODING ON PRIMARY PACKAGING LINES Primary packaging refers to containers which are in direct contact with the drug, and can be be classified in to the following product types - bottles, vials, ampoules, blisters. Each product type presents unique challenges. Bottles - These are the easiest amongst the primary types listed. Thermal transfer printers can be installed on the labelling lines for printing, and coordinated with labellers for product rejection.The challenge is to aggregate them with secondary serial numbers, as the 2D code is present on the circumference of the bottle.Advanced camera systems are already available in the market to pick the 2D code by scanning the bottle 360 degrees. Vials, ampoules - The challenge vial/ampoule lines provide is their small size and high speed of the packaging lines. Laser engraving is the only way to print 2D bar code on the vials/ampoules or their labels.This is difficult but possible. However, the need for serialising vials/ampoules is limited as these products are packed into cartons, which are the saleable unit. Blisters - This is the most challenging of the lot.Till date there is no proven method to serialise blisters on live production lines. In general, printing of text/logo on blisters is done on the lidding foil with the use of UV flexo printers.The challenge in printing 2D code on blisters is the knurling effect of the foil. Knurling is unavoidable for the foil on blister machines, and this would distort the quality of the print.This would lead to high rejection percentage.The other solution to this issue is packing blisters in mono cartons and then printing 2D bar codes on it.

Source: Siddhant Bhambhani, Product Management, ACG Inspection Systems

ply chain to track product movements. Ultimately, the end consumer can verify the product too. It can solve problems such as divergence, product recalls and help identify points of leakage. The 2D data matrix empowers consumers and stakeholders to be sure of the product origin.” The 2D code can also empower patients to check if their medicines are authentic. As Bhambhani points out, “One of the key benefits of serialisation is brand protection with tools like enduser authentication. The 2D code on the label could be verified for authenticity by patients through mobile/equivalent technology. This would be a great driver for individual manufacturers to enhance their brand identity in the market.” All these measures will help companies to secure their products from any kind of counterfeit/fake menace. Kapur expresses, “Labels can fulfil all your needs for regulation, innovation, high speed application, security, differentiation of product in a very economical way unlike primary packaging components. For regulations, labels can have low migration adhesives, inks etc. On the security front, labels can have many features like security inks: thermochronic and optically variable inks, several different security face materials like void and UDV, taggants, holograms, artwork related security etc. In case of differentiation labels, foiling, screen printing, attractive inks and RM, laminations, metallic inks etc, can be utilised.” Yadav mentioned, “Labels manufactured in India are supplied both to the domestic as well as the international markets, which are well versed with GMP. Label suppliers are supported by material suppliers who invest in research to ensure that fresh stocks, adhesives and liner materials are used in compli-

( ance with pharma industry norms and requirements.”

What next? What could be the next move which will help pharma companies as well label manufacturing companies go to the next level? Yadav suggested, “The labelling industry is constantly evolving to cater to the needs of the pharma industry. PharmaSecure in partnership with leading holography providers in India are supplying holographic scratch off labels. These labels combine the best of physical security of the hologram and the digital security offered by our class leading psID(R) products. PharmaSecure has provided over two billion unique codes to the industry and these were either printed directly or applied via labels to the product

Though there were considerable delays in implementing various phases of the track and trace initiative, none in the industry today dispute the benefits of the system packages.” Kapur of JK Labels too is upbeat. As he explains, innovation in pharma labelling could be driven by regulation, security, application, face material or for decorative purposes. For examples, if you have an Minimum Order Quantity (MOQ) you can choose your own face material, gumming GSM and re-

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lease liner. Secondly, labels with luminescence ink could be used to detect labels on high speed lines. Low migration ink and papers, labelling

moist bottles, conformable labels for substrates like blood bags and freeze proof raw materials are other innovative pharma labelling techniques

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and solutions that could soon make their way to the market. Summing up, Dadachanji predicts, “The future of innovative pharma labelling is

bright and offers integrity for conceptualisation and may become a benchmark for quality attributes.” u.sharma@expressindia.com

An Investment in Drug Protection

Pharmaceutical manufacturers around the world choose components with FluroTec barrier film for their injectable drugs. FluroTec film can help reduce the risk of packaging-related failures and may improve component performance in filling lines. With West, you have a partner by your side from discovery to the patient.

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West and the diamond logo, FluroTec® and By your side for a healthier world™ are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. FluroTec technology is licensed from Daikyo Seiko, Ltd. Copyright © 2013 West Pharmaceutical Services, Inc. #7599

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‘We now see the opportunity to further develop our drug delivery business in India’ Karen Flynn, Senior Vice President and Chief Commercial Officer, West Pharmaceutical Services, in an interaction with Sachin Jagdale, divulges the company's growth prospects for the Indian market Your Chennai plant was expected to generate profits by early 2016. What is the current status? What plans have been chalked out to expand production at the site to include elastomer components? We are pleased with the progress of our Chennai plant and it is developing in line with our overall strategic plan for the company, which also includes greater geographic expansion in the coming years. Currently, the facility is fully operational and manufacturing various offerings from our product portfolio of seals. The site was built to spur expansion. and we do have space to grow. In addition to accommodating more seals business, there’s potential to produce other West product offerings in response to regional market demands. What are the India-specific challenges for your company? What are the major gains for West Pharmaceutical Services since its inception in India? Many of the challenges we see in India are similar to what our customers are experiencing across the globe. First, there is a need for high quality components to meet increased regulatory scrutiny. Also, speed to market is an important factor for our customers. To help customers bring their products to market faster, we established a comprehensive global supply chain network

20 EXPRESS PHARMA July 16-31, 2016

traditionally focused on marketing injectable container solutions in India, we now see the opportunity to further develop our drug delivery business here. Several customers in India have expressed interest in West’s Daikyo Crystal Zenith-our technologicallyadvanced cyclic olefin polymer containment and delivery system that offers an alternative to glass. Additionally, a number of customers are utilising our line of reconstitution systems.

Based on the potential for the generics market and the projects already underway in India, we are optimistic about the growth opportunitiesin the country and the region. that includes the necessary infrastructure for the Asia Pacific region. Since the inception of West Pharmaceutical Services in India, we have partnered with pharma and biotech companies who have injectable product portfolios that align with our packaging

and delivery offerings. Today, injectable formulations are one of the fastest growing dosage forms in India due to investments in injectable dosage form manufacturing facilities and the progression of biosimilars to commercial products. While we have

India is known for its prowess in generics but biologics and branded pharma are also among the major focus areas for your company. Looking at this scenario, do you think that the Indian market will earn you enough profits as your other markets do? The generics market is an important area of strategic focus for West Pharmaceutical Services. We understand that customers are looking for a global network to provide shorter lead times and faster time to market with higher performance products to meet increasing regulatory concerns. As an organisation, we are optimising efficiencies to be able to deliver on these expectations. Additionally, as branded biologics are coming off patent and will be available as biosimilars, West Pharmaceutical Services can apply our experience with

these therapeutic classes to recommend products for drugs with similar packaging needs. Based on the potential for the generics market and the projects already underway in India, we are optimistic about the growth opportunities in the country and the region. West Pharmaceutical Services is doing a lot of work in delivery device category. What’s your say on this? When is the wearable injectable expected to be launched? Will it be made available in India as well? Several customer-funded development programmes are underway based on the SmartDose electronic wearable injector platform, including an anticipated commercial launch with one strategic customer later in 2016. This groundbreaking drug delivery system is designed to improve patient experience and encourage medication adherence for therapeutic applications requiring high dose volumes. The SmartDose injector is available for customers to utilise in their clinical trials in India and in all areas in which West operates. What are your current revenue figures globally? In 2015, West Pharmaceutical Services generated net sales of $1.4 billion, which translated into 7.2 per cent sales growth excluding currency effects. Adjusted

( operating profit margin expanded to 13.6 per cent of net sales, and adjusted diluted earnings per share increased to $1.83, a record high and an increase of three per cent over 2014. Excluding an additional $0.29 per share in adverse currency effects, full-year 2015 adjusted diluted EPS would have grown by 19 per cent, a strong achievement in a year of significant transition. West Pharmaceutical Services' operations in India and Government of India's 'Make in India' campaign started almost at the same time. How did you benefit from this campaign?

We provide a very targeted line of products and services for injectable packaging and delivery solutions What is your contribution in making this initiative successful? In India, we see a double digit growth of injectable drugs. This, coupled with the 'Make in India' campaign, is helping us scale up our Sri City plant, which manufactures seals used for injectable packaging for the domestic market as well as for exports. We provide a very targeted line of products and services for injectable packaging and delivery solutions, which is integrated with our global operations and quality systems. Any new products in the pipeline? We have a number of projects in the R&D pipeline for our

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container closure systems as well as drug delivery. Currently, we are working on an extension of our NovaPure line of products. We are also

focusing on wearable devices and developing the next generation of our SmartDose electronic wearable injector. In addition, we are working

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on a seal offering to address potential quality issues that can occur between lyophilisation and capping. We are piloting customer

trials with this product now and will be scaling up in early 2017. sachin.jagdale@expressindia.com

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‘We support the Prime Minister’s Make in India call’ Datwyler is planning a FirstLine plant in Satara, Maharashtra, the company's first facility outside Europe. Rahul Dev, Vice President, Datwyler India, in an interaction with Usha Sharma, discloses the company's corporate plans and strategies

Recently, Datwyler has announced to open its FirstLine production site in Satara. Tell us more about the plant, its investments, production activities commencement, manpower etc.How is it going to cater to the domestic as well as international markets? The FirstLine production facility is specially designed to conform to the highest industry standards, exclusively producing components for healthcare applications. Datwyler manufactures pharmaceutical rubber components such as vial stoppers or syringe plungers in a fully integrated Good Manufacturing Practice (GMP) environment. The company’s most complex rubber components are vial and syringe components from the Omniflex family, which prevent any interaction with the drugs due to their total fluoropolymer coating. The first state-of-the-art FirstLine production site is in Alken, Belgium. The FirstLine plant in India will be the first facility outside Europe and simultaneously Datwyler’s most modern production site. Spread over an area of 24,000 sq metre, the facility will be integrated in the existing premise and will operate in 2017. The site will also offer additional 24,000 sq metre for future growth. The new facility is a major investment and part of the company’s commitment to India and the

22 EXPRESS PHARMA July 16-31, 2016

Asian markets. How will this project work in line with PM Modi's 'Make in India' initiative? The company has a record to grow inorganically and the Satara plant will be the first greenfield project. Do you plan to quit/sideline the inorganic way to grow? We support Modi’s ‘Make in India’ initiative, which is a very ambitious project. India’s pharma and biotech markets are evolving rapidly and they were able to gain traction from global manufacturers, suppliers and customers in the last few years. The country is also being recognised as one of the global manufacturing destinations. Although we have always grown inorganically by way of mergers and acquisitions, we are open to new opportunities and are happy to invest in own operations if they are in line with our company strategy. With our new facility in Satara, we are underlining our commitment to India as we are looking at catering to global markets. The rubber components which are made in India are already distributed globally. 100 per cent is exported to Europe, the US and South East Asia. However, Datwyler Sealing Solutions also has a significant market share in India. We have been supplying our Indian customers from our global plants since the last

20 years. Currently, we have approximately 50 to 60 Indian customers.

With our new facility in Satara, we are underlining our commitment to India as we are looking at catering to global markets. The new facility is a major investment and part of the company’s commitment to India and Asia

Which new product areas you would like to explore and why? Nowadays, drugs are becoming ever more complex and sensitive. As a result, pharma companies demand rubber components which are characterised by low extractables. Therefore, one of the areas we explore is the development of new rubber compounds and coatings with low levels of extractables. With our Omniflex family, we have already developed a series of products which meets these demands perfectly. This product line is exclusively manufactured in our FirstLine facilities, such as the new facility in Satara. In the Indian market, we are also focusing on high-end rubber formulations for products like plunger stoppers, Lyo, serum stoppers and customised rubber stoppers. As a leading partner to global pharma companies and the global number two for closure solutions for injectable medicines, we produce 15 billion components for healthcare products each year. Tell us about Omniflex and which products will be manufactured from the new built facility in Satara. How it will be beneficial for the Indian pharma industry?

Omniflex is our premium product series and first coating to both provide barrier properties and eliminate the closure as a source of silicone oil-based subvisible particles (SbVPs) at the same time. The total coverage by the Omniflex coating offers the benefit of providing a complete barrier which is especially necessary for high-end drugs, mostly biotech drugs, that are very aggressive in nature and must not come in contact with the rubber compound. This coating technology was developed by Datwyler in Belgium and is one of the highest selling products. It meets one of the most important demands within the biologic drug packaging industry at the moment, the reduction or elimination of silicon oil to mitigate risks and reduce time-to-market. The Omniflex series will be produced at the new facility in Satara. Till date, in the Indian healthcare sector , we have been mainly supplying to the diagnostics market. Further, we are the major suppliers to all the syringe manufacturers. On a global level, we are the key supplier for pre-filled vials and syringes. Today, the Indian pharma industry is facing quality issues in the global market and Indian regulators are encouraging the industry to adhere to guidelines, Datwyler is a multinational

( company and have access to various markets. Share your views on the same. Being in the pharma industry, tracking is one of the most important things that we apply. Transparent traceability is one of our major standards. Weâ&#x20AC;&#x2122;ve set up a system where we are connected directly to the servers in Switzerland, i.e. each production step is coded, so we are able to trace hour, person and equipment that have been produced. The government has mandated 2D barcoding on primary packaging line for all pharma exports. Which technology/service have you planned for the Indian pharma companies? We are into manufacturing of rubber and aluminium components. Datwyler has started imprinting UV coding systems to identify counterfeit. For rubber compounds we are more process related. So, one of the main reasons for the rules is counterfeiting. We will always adhere to government guidelines and follow international norms. Which new technologies do you plan to bring from Switzerland and when? We will bring in new technology and best practices not only from Switzerland but also from our plants based out of the US, Belgium, Germany and Italy. We also have a platform to share best practices from plants spread around the world. We are five years young here in India and are invested to bring in more manufacturing and technology to support the Prime Ministers 'Make in India'call. How large is your global manpower strength?What is the headcount in the domestic market? Are there any plans to increase the headcount? We have a global manufacturing footprint on three continents and sell our

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products in over 100 countries. Globally, the division has a workforce of more than 5,600 employees.

What are the company's corporate plans? Presently, Datwyler is expanding in India. Datwyler Sealing Solutions has been

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present in India since 2010. With our operations, we are dedicated to guaranteeing the highest levels of quality and safety, and continue to make

investments aimed at meeting global regulatory requirements. u.sharma@expressindia.com

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‘Packaging innovation has a large role to play in the highly regulated pharma market’ AVPS Chakravarthi, Managing Director, Ecobliss recently delivered a session on innovations in pharmaceutical packaging at WPO Budapest 2016. He in an interaction with Usha Sharma emphasises on the importance of innovative packaging in the pharma industry Recently, you delivered a lecture at WPO Budapest 2016 a lecture on innovations in pharmaceutical packaging. Tell us more about it. It was a proud moment to speak at the international conference at Budapest. Learned delegates from more than fifty countries across the globe participated. I addressed the topic 'Innovations in pharma packaging under the backdrop, Changing World'. Right packaging need be designed around the drug to improve patient compliance, defeat counterfeiting, engage patients, and at the same time create brand awareness. Packaging innovation has a large role to play in the highly regulated pharma market. Whether it is to improve pack protection, deliver convenience and ease of delivery or encourage patient compliance, packaging’s role cannot be underestimated. The biggest challenge in healthcare is to ensure that the package contributes to the overall effectiveness of the treatment over its intended period. Patient adherence should be a primary goal, assuming that the patient is capable of taking medicines independently. Today, studies show that patients start off adhering to their prescriptions but this adherence can fall off over time. Sometimes, this problem can be due to the drugdelivery design, or the taste of the formulation. However, packaging can be a strong factor in getting patients to take their medicines. In the end, the

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final point of contact between the patient and the healthcare providers and/or the distributors of medicine is not the dispensing pharmacist, but the pharma package. If the packaging is difficult to open or use, or features confusing instructions, patient adherence is placed at risk. How will sustainable innovation in pharma packaging help the industry to grow? Well, there have been several innovations put into commercial use that are here to stay for longer periods. Even on the material front, to ensure the moisture barrier and arrest migration, advanced aqueousbased coatings are going to replace the film laminations onto paper and paper boards. Smart packaging is one of the sustainable innovations in the pharma sector. Smart packaging goes beyond the use of simple packaging materials combined with traditional printed features of graphics and barcodes. It is a packaging system that is capable of carrying out intelligent functions (such as detecting, sensing, recording, tracing, communicating, and applying scientific logic) to facilitate decision making to extend shelf life, enhance safety, improve quality, provide information, and warn about possible problems. The importance of eco-friendly and sustainable packaging also never diminishes as environmental concerns are also on the rise. For example, some companies are already working to reduce

Smart packaging is one of the sustainable innovations in the pharma sector their carbon footprint by increasing the use of recycled packaging materials and reducing the amount of virgin materials used in packaging. Usage of biodegradable material in their packaging can be found more in cosmeceuticals and the healthcare sector. What are the key pharma packaging trends which were discussed during the conference? How will it impact Indian pharma packaging? Various topics were touched upon at the conference. Now,

everyone realises that packaging no longer means just to contain the product with nice graphic designs, and a show of hues and printing techniques! Future packaging innovations will go beyond the visual appearance of the packaging, beyond the structural characteristics and the material specifications. They will be more interactive and serve as multi-utility products. The new trends in packaging, in general, would be sustainable packaging. Waste to value propositions will get more clarity and harmonisation. Interactive and intelligent packaging will become more real and get commercialised. There will be growth of sale due to packaging-enabled innovation. As far as pharma packaging is concerned, there will be more and more compliance packs in the market. Patient adherence will be given equal importance. The Indian pharma packaging industry has already realised the market demands and regulatory requirements. It is rapidly trying to keep pace to stay in the race. The Indian government has mandated track and trace on primary packaging for pharma exports. What are your views on this move? The pharma industry continues to advance towards a state of flawless track and trace compliance worldwide, obviously India cannot afford to lag behind. Serialisation, track and trace were once considered as value additions to the

product. It's no longer the same scenario now as they have become mandatory, especially in the pharma industry. Sometimes the process of implementation may be complex and rather confusing, considering different directives from regulators across the globe. What’s your take on the US Consumer Commission petitioning to the US Department of Justice to take action against DRL? While I do not want comment on this specific instance, it only underlines how critical and important it is to comply with legislations. In the regulated markets, especially the US, there is a requirement for childresistant packs, both for unitdose and multi-dose packs. The packaging must be childresistant and at the same time senior-friendly. According to the US Poison Prevention Packaging Act (PPPA), the term 'child-resistant' means that the 'packaging is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly.' Why are pharma companies finding it challenging to adhere to child-resistant packaging? Which are the available competitive solutions? Developing child-resistant packs is always a challenge as it

( has to comply to CPSC requirements. The pack needs to be evaluated by an authorised testing agency for compliance. Subsequent variation, if any, in the container closure system or the design of opening mechanism needs to be evaluated before introducing into market. Designing of the blister pack as well as the forming and sealing materials shall be decided based on toxicity value (â&#x20AC;&#x2DC;Fâ&#x20AC;&#x2122; value) of the molecule. Every manufacturer needs to generate a 'general certificate of conformanceâ&#x20AC;&#x2122; stating the child resistant (CR) testing details for each batch of the product to be marketed in the US. Maintaining the balance on compliance to child resistance while facilitating easy access to elderly people is always an uphill task. With demand for these packs are on the rise, there have been various new innovative developments in this arena. The world's first reclosable child resistant carton, the Locked4Kids is the new kid on the block. Burgopac's slide CR pack, Medlock Ez system, Amcor's AOF featured child resistant blister lidding are a few other examples. The child resistant closures for jars and bottles have been in existence though with limitations, for quite some time. What is the future of the Indian pharma packaging industry? India exports several APIs and dosage forms to almost all countries in the globe, be it the developed countries or the developing ones. Since these products deal with the health of the people, each country takes utmost care in importing these medicines and in assessing their quality, genuineness and source. Hence, each importing country has stringent regulatory requirements for import of medicines and they are unique to each country. There is a requirement for exclusive packaging and labelling in all the cases. Indian pharma industry has a big boost with the just announced

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government decision that clears any hurdle of FDIs into this sector. With this new ruling, 74 per cent of foreign direct investment has become

possible. These factors will drive growth in the pharma packaging industry. Influence of regulations, increasing needs of customers and the medical

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practices, rise in requirements of tamper-evident, childresistant and senior-friendly packaging will lead to the evolution of new packaging

technologies. Pharma packaging industry in India obviously will grow along with the core industry. u.sharma@expressindia.com

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â&#x20AC;&#x2DC;We conduct exclusive industry need-based programmesâ&#x20AC;&#x2122; SIES-SOPâ&#x20AC;&#x2122;s endeavour is to groom professionals dedicated to the cause of developing packaging that is functionally efficient with quality parameters conforming to international standards, besides being cost effective and environment friendly. PV Narayanan, Chairman, SIES School of Packaging, talks more about the institute in a chat with Sachin Jagdale

What was the rationale behind laying the foundation of SIES School of Packaging? SIES, an organisation fully devoted to education and skill development, is over a century old now. The centre constantly reviews and identifies areas of potential opportunities that will develop employment opportunities and entrepreneurship-oriented subjects. Packaging science, technology and engineering was not given adequate importance despite its scope, high growth and new avenues. Interestingly, the SIES School of Packaging/Packaging Technology Centre (SIES SOP/PTC) under the apex body of SIES, is a first of its kind institute in the country, in the private sector, which have started packaging programmes and have received overwhelming support from the industry. How many students have been trained till now at the school? There are more than 1,000 post graduate students who have undertaken the distance education programme, part time and short-term courses. An equal number of qualified engineers from the

26 EXPRESS PHARMA July 16-31, 2016

engineering branch have also joined the brand of packaging specialists, numbering over 500. Which courses do you offer? How do you manage to keep these courses in sync with global packaging requirements? We offer two-year post graduate diploma, which is a full-time course, and oneyear graduation in technology, a part time and correspondence course The two-year post graduate diploma has three semesters, which covers technical sessions, laboratory work, practical classes, field and industrial visits, workshop training, besides dissertations, seminars and projects. The fourth semester is on industrial training. Also, there are short-term courses, which highlights on products / materials, those which are in demand in the industry, like package design and development, quality parameters and quality assessment. We also conduct exclusive industry need-based programmes. Such programmes have been designed based on pre-visits, discussions and drawing up of course contents. These

SIES SOP/PTC is a first of its kind institute in the country, in the private sector, which have started packaging programmes and have received overwhelming support from the industry

endeavours have been well received by the industries based in India and abroad. SIES SOP/PTC also provides training to Ministry of Micro Small and Medium Enterprises (MSMEs) (GoI) to update their skill and information. It thus benefits micro, small and medium industries, which eventually helps package converters, package users and new entrepreneurs. The centre also organises technologyoriented programmes. SIES SOP PTC was affiliated to overseas institutions like Belgium Packaging Institute and Australian packaging institute and is currently affiliated with Rutgers, USA. Dialogues are in progress with similar other overseas universities/ institutions. Do you have any tie-ups with the packaging companies? If yes, please explain the nature of these tie-ups. The SIES SOP/PTC since its inception has evolved a lot and we have tie ups with various leading packaging companies in India and overseas. To name a few, the list includes: M/s. Avery Dennison, M/s Esko Graphics, M/s DuPont India, M/s Essel Propack, M/s Positive Packaging

Industries, M/s Wraptech Machines, M/s ITC, M/s Mespack India, M/s IMA- PG India, M/s. Bosch, M/s Safal Flexibond, M/s USP Packaging Solutions, M/s Pacific Plastic Industries, M/s Alia Diadeis etc. Most of the companies have contributed towards educational infrastructure, scholarship and awards, performance medals, group project recognitions etc. Nearly 12 companies have provided financial support to best performing students, students from the economically backward section and awards for the best female students. Do you get sponsors for expensive equipment/ machinery, required during the course? Quite a few industries have contributed towards infrastructure facilities and also for laboratory equipment. Most of the financial inputs have come from the SIES trust. The industry also avails testing and quality control facilities established at the centre on a regular basis. SIES/SOP/PTC is an ISO 9001:2008 certified institute and Scientific and Industrial Research Organisation recognised by the Department of Scientific, Industrial and

( Research (DSIR) under Ministry of Science and Technology, Government of India. The SOP/PTC has earned reputation and recognition as a premier institute for testing, quality assessments, design and developments, training and education as well as R&D in the field of packaging. Do you provide placement assistance to students? Till now how many students have got placement offers and in which companies? Student placement is our top priority. Industry-sponsored scholarships and projects

SOP/PTCâ&#x20AC;&#x2122;s alumni provides impetus and opportunities for new pass outs. Increasing activities at the centre itself is a source of opportunity for the experienced and new ones enable students to bag internship. The centre also helps in overseas placements. SOP/PTCâ&#x20AC;&#x2122;s alumni provides impetus and opportunities for new pass outs. Increasing activities at the centre itself is a source of opportunity for the experienced and new ones. Tell us about your expansion plans? As a new initiative, SIES SOP/PTC is in the process to set up a Corporate Industry Advisory Body. It will help to

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bring in an intensive industry affiliation and will guide its activities and programmes. Actions have been initiated towards affiliations with

institutions and universities both from India and abroad. New programmes of industry interest and of direct relevance are being identified

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and implemented. The process to expand the infrastructure includes updating the laboratory and research facilities. State-wise industry

association have been planned to expand market for services offered by the SOP/PTC. sachin.jagdale@expressindia.com

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‘Packaging audit is a unique service rendered by PCR’ In a span of less than four years, Packaging Clinic and Research Institute (PCRI) has marked its presence in the Indian pharma industry. The institute has designed several programmes for pharma packaging professionals to help them deliver better services. Prof Karna BK, Director-PCRI, Packaging Clinic and Research Institute, in an interaction with Usha Sharma talks more about the institute

Tell us about the ongoing activities of PCRI? PCRI renders its services to various industrial sectors in order to enhance quality, packaging standardisation and cost optimisation. To promote the profession of packaging, PCRI conducts various packaging training programmes. They are packaging skill development programme, Executive Development Programme (EDP) and one year post graduate programme in packaging. PCRI provides packaging consultancy for package design and determination of shelf life of packaged products. Which new trends do you see in the global market? Package design focuses on three-areas. Structural packaging design for package stability, graphic packaging design for aesthetic appeal and structural packaging design for products required packaged life. Determination of shelf life of the packaged products are being done on the prime basis of studies of PMT factor i.e. nature of product, nature of the market and nature of transport and thereafter product packaging stability test through accelerated climatic exposure study.

28 EXPRESS PHARMA July 16-31, 2016

What kind of training programmes do you conduct for Indian pharma packaging industry and how it helps to create an employment opportunity? So far, how many people have been trained by PCRI? PCRI’s annual three-day EDP on ‘Packaging of Pharma Products’ is one of the best programmes that we conduct where pharma industry professionals participate and present various case studies. Since 2012, we have trained 120 professionals. PCRI also has the following programmes ◗ ITP Intensive Training Programme in Packaging: It is a three-month programme: where candidates may select option with pharma packaging. Till now, 90 professionals have been trained. ◗ Post Graduate Diploma in Packaging (PGDP) is a oneyear programme. In the first batch 22 professionals were trained. What type of recognition has PCRI received? PCRI has been recognised by various associations in the country such as Packaging Club, Federation of Telangana & Andhra Pradesh Chamber of Commerce & Industries (FTAPPCI) and Federation of Corrugated Box Manufacturers (FCBM) etc.

PCRI also offers packaging audit and consultancy. Elaborate more on the same. Packaging audit is a unique service being rendered by PCRI for bringing the concept though ‘justification of specification’ which delivers cost optimisation and quality enhancement. Around 15-20 pharma companies approach PCRI for packaging assistance. What research activities have been undertaken to enhance pharma packaging in India? We have undertaken a lot of research activities. Research activities need lot of financing at an initial stage. We have conducted research activities in the following. ◗RCT Kraft paper for Corrugated Box. ◗Al foil free barrier materials ◗Abrasion loss relationship ◗Induction seal strength

PCRI has been recognised by various associations in the country such as Packaging Club, Federation of Telangana & Andhra Pradesh Chamber of Commerce & Industries (FTAPPCI) and Federation of Corrugated Box Manufacturers (FCBM) etc

What is the reason behind pharma companies delaying in adopting technology for the life sciences segment where similar technologies are being adopted in the global markets? Indian pharma companies are aware of all these global trends. Few of them have already adopted for the US and EU regulated markets. The Union government is very aggressive to accept these technologies. u.sharma@expressindia.com

( REPORT

Intelsius launches Plantol PCM It will be beneficial for the transport of whole blood products INTELSIUS, A DGP company, a designer, manufacturer and distributor of temperaturecontrolled packaging solutions, based in York, has extended its ORCA range, with the introduction of its +22°C Plantol PCM. The +22°C Plantol PCM is the company’s latest addition to its proprietary range of Phase Change Materials and is manufactured specifically to the temperature range 2024°C for the transportation of whole blood products. With the now greater need for more complex shipping systems, the +22°C Plantol provides an extended solution to the ORCA range, providing exemplary performance as an ambient PCM in hot conditions over 144 hours against ISTA 7D, for every sized ORCA. Neil Sherman, Manager, Technical Services commented, “The addition of this PCM means that ORCA is now even more adaptable to meet our client’s exact requirements. The introduction of +22°C Plantol demonstrates Intelsius’ commitment to innovation and meeting the greater complexity of today’s global shipping requirements.” Intelsius’ Plantol range of PCMs are non-toxic and non-fossil fuel derived and have been designed for exceptional performance with minimal environmental impact. EP News Bureau-Mumbai

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July 16-31, 2016

THE MAIN FOCUS

cover ) I N T E R V I E W

Almost all major manufacturers of pharma products in India have acknowledged and responded to the counterfeit challenge in India Javin Bhinde, Managing and Chief Executive Officer, SynCore Consulting shares details of the PatientSafe India conference this year and its objectives. He also elaborates on the steps to deal with the challenge of counterfeit medicines, with Express Pharma What is the extent of the counterfeit challenge in the pharmaceutical sector globally and in India? Drug counterfeiting has emerged as a challenge not only in India but also globally, however it is considerably difficult to define the extent to which it has penetrated the pharma markets across the world. This is because there are many estimates of the scope and scale of the market in counterfeit medical products but little validated evidence to underpin those estimates. WHO has withdrawn all of their previous estimations of the scale of the problem and in 2013 launched a global surveillance system to report counterfeit incidents, to assist in arriving at a more accurate and validated assessment of the scope, scale and harm. In 2009, CDSCO found 11 out of the 24136 (0.046 per cent) samples collected from various retail pharmacies as spurious and three out of 2976 samples (0.1 per cent) as substandard (not conform to claim with respect to Assay on chemical analysis). As per WHO reports 50 per cent of illicit online pharmacies are selling counterfeit medications throughout the world. INTERPOL is running operations such as Operation Storm (Southeast Asia) and Operations Giboia, Mpili and Porcupine (all regions of Africa, for example). Between 2010 and

30 EXPRESS PHARMA July 16-31, 2016

2014, these operations have led to the arrests of 1,400 suspects, the suspension of 57,000 illicit online pharmacies and the seizures of 500 tonnes and 30.3 million units of illicit medicines. Although many of the reports are extrapolations of sampling data and are often contested by other experts, one fact that none of them deny is the seriousness of the problem and the burning need to address it. What are the measures being taken by regulators, both globally and in India, to combat the counterfeit challenge in the pharma sector? Many countries especially in Africa have deployed SMSbased verification on authenticity. These have been shown to be quite effective in their application. International Medical Products AntiCounterfeiting Taskforce (IMPACT) has been formed by WHO to tackle the issue. IMPACT has done a lot of work in securing worldwide cooperation across all stakeholders which many believe is the key to a successful long term resolution of the problem. Interpol has Project Pangea to tackle online counterfeit retail and Project Storm for anti-counterfeit in South-east Asia which is particularly sensitive to the issue. Track and trace technologies have been deployed by many European bodies in many different forms

and have also been shown to be successful in identification and rapid response to incidences of attempted entry of counterfeit drugs into mainstream channels. Serialisation is also gaining momentum among many manufacturers and regulators as a robust measure against drug counterfeiting.

Serialisation is also gaining momentum among many manufacturers and regulators as a robust measure against drug counterfeiting

What measures have pharma companies taken to safeguard their products and supply chain? Pharma companies have taken a serious stance towards counterfeit drugs in all markets. The counterfeiting challenge is being addressed by a multi-pronged strategy centred on the following three pillars: Availability: The availability of genuine drugs easily and reliably is likely to go a long way in prevention of the counterfeiting menace, especially in developing markets where the penetration of medicines may be limited Awareness: The problem of drug counterfeiting is usually one that goes unnoticed when committed. The patient who consumes drugs with the wrong composition, spurious ingredients, and expired drugs or in some cases no active ingredients at all may be assumed to have suffered a deterioration in health due to some medical reason or due to a wrong diagnosis. Awareness

of the counterfeiting problem, especially in geographies susceptible to the problem is a prime factor in initiating the process of its elimination. Action: The regulations which are in effect need to have stricter punitive clauses as well as tighter enforcement by policing authorities to rein in the burgeoning number of counterfeiters. As it stands today, the regulatory and enforcement intensity leaves a lot to be desired. Which pharma companies in India have responded to the counterfeit challenge in the pharma sector? Almost all major manufacturers of pharma products in India have acknowledged and responded to the counterfeit challenge in the India. This is abundantly clear by the formation of a role of a â&#x20AC;&#x2DC;Chief Security Officerâ&#x20AC;&#x2122; who is primarily tasked with detection and prevention of drug counterfeiting. This kind of a role was hitherto unknown in the business before the emergence of drug counterfeiting as a legitimate threat. The creation of a drug supply chain that is flexible enough to respond quickly to the actions of counterfeiters while simultaneously being lean enough to minimise the effort of policing along with reducing the potential points of leakage to a minimum is widely

( accepted a necessary condition to tackling drug counterfeiting. Such a superior supply chain design coupled with technological breakthroughs in anti-counterfeiting measures has led the way forward for most companies. Technology is currently being deployed to tackle the following key aspects of the process: ◗ Track and Trace ◗ Detection ◗ Packaging ◗ Online trade Also, manufacturers are increasingly developing collaborative measures together with law enforcement agencies for rapid detection and response. Have anti-counterfeiting measures resulted in increased costs at the manufacturing, quality and supply chain levels? Many of the technologies that are potentially being developed and evaluated are currently likely to impose an economic penalty on the value of the medicine, which puts a strain on the resource strained economies. But, significant ground is being made in making these technologies scalable, easily adaptable and economically viable. A significant challenge in the past, widespread adoption of information technology, rapid reduction in prices of devices (like RFID, mobile phones etc) in some cases has reduced the

One of the critical factors which will decide the fate of any anticounterfeiting exercise is the ability to galvanise widespread collaboration across different stakeholders across government, law enforcement, manufacturers, distributors, etc cost of deployment by a factor of 10. But the deployment of barriers to counterfeiting does represent an economic cost burden that manufacturers and governments alike have acknowledged as an investment to protect the citizens and the overall interests of the practice of medicine. Whatever the cost, it is in the patients interest in the short and long run to focus on and address the issue at this point. What are the average timelines to implement anti-counterfeiting measures? (Mention options depending on the type of projects, products, dosages, etc) Packaging based solutions like light sensitive labelling, holograms and bar codes can be deployed rapidly i.e. within three to six months. Other methods like serialisation, SMS-based authenticity verification need development of some infrastructure but can

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be deployed within six to eight months. Detection systems like spectroscopes can be readily bought and enforced but represent major investments. But the fact remains that deployment of anticounterfeiting technologies isn’t merely about the timeline, it is about the will power and the steadfastness of the top management. The objective, as in the case of most crime prevention measures, has to be to create a strong deterrent rather than enable 100 per cent detection. As the economics of these measures play out, the design of any anticounterfeiting measure must aim to achieve near 100 per cent probability of detection and prevention rather than develop the ability to seek out every last counterfeit product. We would be far better off if the points of leakage are sealed off through effective deployment of technology than

THE MAIN FOCUS

by developing systems to identify the counterfeits in a sea of genuine drugs. The patient is often the silent stakeholder in the counterfeit issue but often suffers the most. Are there any precautions that they can take? Some precautions that patients need to take when procuring medicines are as follows: ◗ Check the physical appearance of the medicine (colour, texture, shape and packaging) ◗ Identify if the packaging has missing information such as lot no. or expiration date ◗ Check if the original packaging seals have been opened, damaged, repaired or altered ◗ Product labelling that contains misspelled words or looks different from the standard packaging ◗ Check to see if it smells and tastes the same when you use it ◗ Seek the help of your pharmacists or physician in case of any doubt ◗ If you suffer any severe/ secondary effect from the drug please contact your doctor In the future, deployment of further anti-counterfeiting measures are likely to add a couple of steps to the purchase process, but patients need to be willing to take the additional precaution as it will lead to a radical improvement in our ability to tackle the problem.

Also whenever noticed, any instance of counterfeit drugs of any form must be brought to the notice of authorities. An aware populace collaboratively working with the law enforcement and pharma manufacturers is the critical factor in eliminating this problem. What does the upcoming conference, PatientSafe India, hope to achieve? What is the vision and goals of this conference? One of the critical factors which will decide the fate of any anticounterfeiting exercise is the ability to galvanise widespread collaboration across different stakeholders across government, law enforcement, manufacturers, distributors, retailers, hospitals and practitioners. Nearly every successful effort in thwarting counterfeiting has been the result of alignment and collaboration. This conference attempts to offer such a platform for various stakeholders to achieve this elusive alignment and collaboration through: ◗ Sharing of ideas and information ◗ Identification of key levers ◗ Development of joint action plans ◗ Presentation and agreement on areas of external intervention ◗ Target setting and progress monitoring

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MANAGEMENT INSIGHT

Brexit impact: Should the Indian pharma industryworry? Sameer Walia, Managing Director, The Smart Cube examines the potential implications of Brexit on the overall pharma industry in India

IN EARLY 2016, multiple reports from different research houses estimated >15 per cent y-o-y growth for the Indian pharmaceutical market during 2016–2020. While Brexit speculations were doing the rounds that time as well, no one knew that it would really come true. Now that Brexit will actually happen, the market is flooded with mixed reactions—while some believe that the impact of the weakening GBP is likely to be short term, others consider that the uncertainty, and hence the impact, is likely to extend to the medium term. However, experts unanimously agree that the UK’s decision to divorce the EU will create, and has already created, commotion in the Indian pharma industry. Let’s examine the potential implications of Brexit on India’s pharma industry.

Limited exposure, limited impact on revenue Majority of top Indian pharma companies—Aurobindo Pharma, Cadila, Cipla, Dr Reddy’s Laboratories, Glenmark, Lupin and Sun Pharma—have low revenue dependence on the EU, especially from the UK (See table); in fact, the US is the key market for most of them. As a result, these companies are likely to face limited impact of the currency devaluation following the Brexit referendum results. The Indian Credit Ratings Agency (ICRA) also believes that the event will have negligible impact on the Indian pharma industry as a whole, as European markets account for

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July 16-31, 2016

Sameer Walia, Managing Director, The Smart Cube

EXPOSURE OF INDIAN PHARMA COMPANIES TO EU/UK

The impact on Indian pharma is going to be minimal, as the UK and the EU account for less than 13 per cent of the overall Indian pharma revenues 10–13 per cent of the total industry revenue. However, because of GBP devaluation, the country’s drug exporters have incurred losses of ~` 500 crores (as of June 27, 2016). Drugmakers with significant sales exposure to the EU/the UK are also likely to

Company

Percentage of Sales Exposed to EU/UK

Aurobindo Pharma

1.5% (UK)

Cadila Pharma

3% (EU)

Cipla

4.5% (EU), including <1% (UK)

Dr Reddy's Laboratories

11% (EU)

Glenmark Pharma

9.5% (EU); 2.5% (UK)

Lupin

3% (EU)

Sun Pharma

4% (EU)

(Source: Bank of America Merrill Lynch)

witness a decline in revenue.

Going beyond revenue: Regulatory delays and opportunities for M&A As the UK ends its relationship with the EU, London-based European Medicines Agency (EMA)—which approves treatments for all EU countries—will have to relocate to a country within the EU. This will increase uncertainty around the drug approval process, leading to regula-

tory delays—which further leads to lost revenues. Although, uncertainties offer opportunities too. Indian companies, for instance, can actually look at M&A activity in the UK. M&As, especially at a time when the GBP is on a depreciating trajectory, indeed offer an effective strategy to enhance footprint.

The road ahead… Brexit impact on Indian pharma is going to be minimal,

as the UK and the EU account for less than 13 per cent of the overall Indian pharma revenues. The impact will primarily be driven by movements in the currency. One thing that remains to be seen is how the Indian rupee is likely to react to the US dollar, as any depreciation will act as a natural hedge for Indian pharma companies. Most importantly, we cannot rule out the recent approval for 74 per cent FDI under the automatic route, as it opens up a plethora of opportunities for companies in the UK and EU. While some drug makers and experts have voiced opinions about the potential impact, others are taking stock of the situation before reaching a conclusion. From the above information, it seems that at present, the Indian pharma industry is immune to the UK’s association with the EU, although only time can tell the future of the industry. (With inputs from Mayank Taneja, Senior Analyst, The Smart Cube)

REPORTS

Major players in Type II diabetes shifting focus to pricing to maintain market share According to a report by GlobalData, human insulins and many insulin analogs are currently off patent or will soon lose their patents

THE HIGHLY mature Type II diabetes (T2D) market, which is forecast to be valued at $58.7 billion by 2025, will see pharmaceutical companies prioritising competitive pricing in order to offset the impact of patent expiries ahead of improving existing products, says research and consulting firm GlobalData. According to the company’s report, human insulins and many insulin analogs are currently off patent or will soon lose their patents. The patents for Humulin and Novolin expired in 2001 and 2002, respectively. More recent patent losses include Eli Lill’ys Humalog (insulin lispro) in 2013, Novo Nordisk’s NovoLog/NovoRapid (insulin aspart) in 2014, and Sanofi’s Lantus (insulin glargine) in 2014–2015. Lantus is already beginning to suffer erosion to the first to market insulin biosimilar, Eli Lilly’s Abasaglar (insulin glargine). Jesus Cuaron, Senior Analyst, GlobalData, covering cardiovascular and metabolic disorders, explains, “Sanofi, historically a major player in the T2D space, is a good example of a company which has turned its attention to price rather than therapeutic value as the latestage pipeline becomes saturated with me-too drugs. The company’s recently marketed drug Lyxumia (lixisenatide) was launched at a heavy discount to rival glucagonlike peptide-1 receptor agonists (GLP-1RAs), AstraZeneca’s Byetta (exenatide) and Novo Nordisk’s Vic-

toza (liraglutide). “As Lyxumia is the fourth-tomarket GLP-1RA product, with a low level of differentiation in the GLP-1RA space, Sanofi had to offer a competitive price in order to win market share. With health systems in many markets facing cost pressures today, this is likely a strategy that other companies will adopt with their me-too drugs that are in late-stage development.” Although a waning factor, major players in the T2D market are also responding to the emergence of insulin biosimilars by offering improvements on existing therapies. Sanofi also recently launched Toujeo (insulin glargine, U300), a superior version of its own product Lantus, in addition to developing a fixed-dose combination of Lantus and its Lyxumia (lixisenatide) in order to protect its franchise. Cuaron notes: “In addition to recently launched Toujeo, Sanofi is developing a biosimilar candidate of its own: SAR-342434. Currently in phase III trials, SAR-342434 is an insulin lispro biosimilar to Eli Lilly’s Humalog. “Overall, GlobalData believes that Novo Nordisk will maintain its lead in the insulin market by 2025, with its several marketed insulin analogs and ultra-rapid acting insulin, FIAsp (faster-acting insulin aspart), which is currently in Phase III trials.”

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EP News Bureau-Mumbai

EXPRESS PHARMA

July 16-31, 2016

MANAGEMENT

GSK’s vaccine set to revolutionise meningococcal disease prevention market GlobalData report mentions that of the three major meningococcal vaccines currently being developed in the 8MM, only GlaxoSmithKline’s MenABCWY vaccine has the potential to significantly change the approach used by countries to prevent meningococcal disease A VACCINE protecting against meningococcal serogroups A, B, C, W, and Y (MenABCWY) is set to revolutionise meningococcal disease prevention across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and Brazil, according to research and consulting firm GlobalData. The company’s report states that of the three major meningococcal vaccines currently being developed in the 8MM, only GlaxoSmithKline’s (GSK) MenABCWY vaccine has the potential to significantly change the approach used by countries to prevent meningococcal disease. Its launch would offer a vaccine

that can protect against all common serogroups found in the 8MM in a single product and, should it perform well in upcoming phase III studies, has the potential to become the leader in a market projected to be worth $1.8 billion by 2025. Mirco Junker, Analyst, GlobalData covering infectious diseases, explains: “MenABCWY, effectively a coformulation of GSK’s Menveo and Bexsero, could reduce the shot burden for patients, and will hold an advantage over other formulations in its combination of conjugated polysaccharides and purified proteinbased antigens.” “While polysaccharide vaccines can provide excellent pro-

GSK’s MenABCWY vaccine will have sales of just under $437 million in 2025 across the 8MM tection in individuals against a specific set of serogroups, these vaccines are limited in their protective ability to these serogroups. By contrast, protein-based meningococcal vac-

cines, which include the MenB vaccine, can also protect against strains from other serogroups. “Combining polysaccharides from a MenACWY vaccine with the protein-based antigens from Bexsero into one vaccine, therefore, might provide effective protective coverage.” Following the expected launch of a MenABCWY vaccine in the US and the five European markets in 2020, national routine immunisation schedules are likely to be altered, with the new MenABCWY vaccine potentially replacing a majority of routinely administered meningococcal vaccines. Indeed, MenABCWY is touted as a possible replacement for the

MenACWY booster currently recommended to be administered to adolescents in the US. Junker concludes, “Currently, there are no products in the pipeline specifically designed to provide long-term protection against invasive meningococcal disease. However, several clinical trials, including for MenABCWY, are being conducted to further address this important unmet need in meningococcal disease prevention.” GlobalData forecasts that GSK’s MenABCWY vaccine will have sales of just under $437 million in 2025 across the 8MM. EP News Bureau-Mumbai

Pharma industrylicensing deals soared to record $46.2 billion in 2015 According to GlobalData whitepaper, there has been a surge in investment of deals in the Immuno-Oncology (I-O) space over the past five years LICENSING DEAL values in the pharmaceutical industry rose by 37.1 per cent year-toyear, from $33.7 billion in 2014 to $46.2 billion in 2015, driven primarily by Sanofi, which struck three licensing deals that totalled nearly $9 billion, according to GlobalData. In the company’s latest whitepaper, Gianfranco Zeppetelli, Deals Analyst, GlobalData explains, “Sanofi inked two key partnerships for metabolic indications, the first of which was a $4.3 billion part-

34 EXPRESS PHARMA July 16-31, 2016

nership with South Korea’s Hanmi Pharma. Sanofi gained exclusive worldwide license to develop and commercialise three pipeline products for the treatment of type II diabetes. “Sanofi also made a $1.7 billion agreement with Lexicon Pharma to manufacture and sell sotagliflozin (LX-4211), an investigational oral dual inhibitor of SGLT-1 and SGLT-2 currently in phase III development.” GlobalData’s whitepaper states that there has been a

surge in investment of deals in the Immuno-Oncology (I-O) space over the past five years, as immunotherapies have advanced significantly, becoming the pillar of cancer treatment. In the I-O space, Sanofi signed a $2.7 billion deal to co-develop Regeneron’s REGN-2810, a programmed cell death protein 1 (PD-1) inhibitor currently in Phase I testing. Another important I-O partnership was Pfizer’s $2.9 billion agreement with Merck to develop and commercialise

avelumab (MSB-0010718C), an investigational anti-PD-L1 monoclonal antibody in phase II development as a potential treatment for multiple metastatic and advanced solid tumours, including breast and prostate cancer. Under the terms of the agreement, Merck will receive an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments of up to approximately $2 billion. Zeppetelli continues, “Pharma companies are adapt-

ing to current market dynamics and positioning themselves for growth through portfolio transformation, targeted deal-making, cost-cutting measures, and sharpening their focus on highperforming therapeutic areas, and geographic markets.” “We believe deal prices will continue to rise in 2016, as many big pharma companies look to increase their market share in specific therapeutic areas against their competitors.” EP News Bureau-Mumbai

RESEARCH UPDATES

Sandoz announces EGALITYtrial results The EGALITY study met its primary endpoint demonstrating equivalent efficacy of Sandoz biosimilar etanercept candidate to the originator product at week 12

andoz, a Novartis division, has announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met. The study compared the safety and efficacy of its biosimilar etanercept candidate with the originator product, Enbrel in patients with moderate-to-severe chronic plaque-type psoriasis and was presented at Psoriasis 2016, the 5th Congress of the Psoriasis International Network (PIN), Paris, France. "The EGALITY data, showing our biosimilar etanercept to be bioequivalent to the originator product, is part of the comprehensive data package submitted to the EMA and FDA," said Malte Peters, Head Global Clinical Development, Biophar-

maceuticals, Sandoz. "If our biosimilar etanercept is approved for the same indications as the originator product, more

patients with chronic inflammatory conditions like rheumatoid arthritis and psoriasis will have access to life-changing biologic treatment options," Peters continued. Additional data from the study confirms similarity between the biosimilar etanercept candidate and the originator product in terms of safety and immunogenicity; the incidence of adverse events at week 12 was comparable. "The EGALITY study is a landmark in clinical trial design. Data has been collected from over 500 patients in one year with multiple treatment switches where a patient receives either the biosimilar etanercept candidate or the originator product on a number of alternate occasions," said Professor Diamant Thaçi, Comprehensive Center for In-

flammation Medicine, University Medical School SchleswigHolstein, Lubeck. "Data from this study, in addition to analytical, functional and pre-clinical studies, provides confidence in the comprehensive data package that is the basis for biosimilar medicine approval and use by healthcare practitioners," Thaçi continued. Sandoz announced that its biosimilar etanercept candidate was accepted by the EMA and FDA for regulatory review in the second half of 2015. Sandoz is seeking approval for all indications included in the label of the originator product, which is used to treat various inflammatory conditions, including rheumatoid arthritis and psoriasis.

Study conducted on monkeys show promise the large range of vaccine candidates now being designed," said Professor Adrian Hill, director of Oxford University's Jenner Institute, which did not conduct the mouse study but is also developing Zika vaccines. Separately, US scientists said they have developed a model of the Zika virus in monkeys, a close proxy for human disease. The studies advance efforts in fighting the mosquitoborne Zika virus, which has

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swept through the Americas and Caribbean since last fall, and has been linked to thousands of cases of microcephaly, a rare birth defect, in Brazil, as well as to neurological disorders. The World Health Organization declared Zika a global health emergency. “With diseases spread by biting insects, such as Zika, standard quarantine measures are useless, so stopping an outbreak in its tracks requires a

TESARO SAID its experimental ovarian cancer drug niraparib met the main goal of prolonging survival in patients, without the disease worsening, in a late-stage trial, sending its shares to a record high. About 22,000 women are diagnosed with ovarian cancer in the US every year, and nearly 80 per cent are diagnosed after it has progressed to a severe stage. The trial which enrolled more than 500 patients, included subjects some of whom had a BRCA gene mutation. BRCA is a tumour suppressing gene, and ovarian cancer patients who carry this mutation are more

EP News Bureau-Mumbai

Zika vaccines prove 100 per cent protective in mice MICE GIVEN a single shot of one of two experimental Zika vaccines were completely protected when exposed to the virus one to two months later, a promising sign that similar vaccines under development for humans will protect against Zika, US researchers said. “This is an encouraging first step in Zika vaccine design and pre-clinical testing. This new mouse model should be useful for comparative assessments of

FDA panel backs approval of Pfizer’s opioid painkiller

vaccine-led approach,” said Dr Derek Gatherer, a lecturer in the division of biomedical and life sciences at Britain's Lancaster University. In the mouse study, published in the journal Nature, a team led by Dr Dan Barouch of Beth Israel Deaconess Medical Center and Harvard Medical School, tested two different vaccine candidates in a strain Continued on Page 36

treatable as they respond better to chemotherapy. Analysts said the data increased the probability of niraparib being used as a first-line treatment for ovarian cancer and BRCA-related breast cancer. “The data was even better than our bullish expectations,” Mizuho Securities analyst Eric Criscuolo said. In patients with BRCA mutation, progression-free survival for those treated with niraparib was 21 months, compared to 5.5 months for those on a placebo. In patients without the BRCA mutation, who are relatively more difficult to treat, the progression free survival was 9.3 months compared to 3.9 months, for those on placebo. Reuters

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RESEARCH Continued from Page 35 of mice that develops Zika symptoms. One candidate, a DNA vaccine, was developed by Barouch and colleagues. It contains bits of genetic material from a Zika virus strain from Brazil. The other was made from a purified but inactivated version of the Zika virus from Puerto Rico. That vaccine was developed by researchers at Walter Reed Army Institute of Research in Silver Spring, Maryland. Mice given either type of vaccine were 100 per cent protected from Zika after a single shot. Unvaccinated mice that were exposed to the virus all developed symptoms of Zika. Both types of vaccines - DNA and inactivated virus vaccines have been successfully developed to prevent infection from viruses related to Zika, including West Nile and dengue. The team also showed that antibodies taken from immunized mice could be used to protect other, unvaccinated mice, offering proof that the antibodies pro-

duced by the vaccines were specific to Zika. "We need to be cautious about extrapolating data from a mouse model into humans," Barouch said. But the fact that the vaccines protected mice and that their antibodies protected other mice from Zika was grounds for optimism over the development of a Zika vaccine, he said. At least 15 companies and academic groups are racing to develop Zika vaccines, according to the WHO. US vaccine maker In-

ovio Pharmaceuticals last week got US Food and Drug Administration approval to begin testing its Zika DNA vaccine in humans. Oxford University's Hill stressed that there are still years of testing needed before a finished vaccine will be available for humans. In another advance, researchers at the University of Wisconsin reported that they have successfully infected rhesus macaques with an Asian strain of the Zika virus that is currently circulating in the

Americas. The study, published in the journal Nature Communications, shows that monkeys which have immune responses similar to humans - can be used to study Zika. In the study, David O'Connor and colleagues inoculated eight rhesus macaques - including two pregnant monkeys with a strain of Zika virus currently circulating in the Americas. All eight animals were infected. Tests showed viral particles in their blood, saliva, urine and spinal fluid. All ani-

mals stayed infected for at least 21 days, and some remained infected for at least 57 days. A second exposure to Zika 10 weeks after the first did not make the animals sick, suggesting that antibodies developed by the monkeys protected them against a second case of Zika. This is a promising sign that humans may similarly be able to develop protective antibodies against the virus. The scientists are still working to understand whether the pregnant monkeys will pass the infection along to their fetuses, and whether infected monkeys can transmit the virus sexually, as has been seen in infected humans. US health officials have concluded that Zika infections in pregnant women can cause microcephaly, a birth defect marked by small head size that can lead to severe developmental problems in babies. The WHO has said there is strong scientific consensus that Zika can also cause Guillain-Barre, a rare neurological syndrome that causes temporary paralysis in adults. Reuters

Merckâ&#x20AC;&#x2122;s Keytruda prolongs life in big lung-cancer The company hopes the new data will allow its injectable drug, which has a list price of about $150,000 a year, to be used earlier as a treatment for the most common form of lung cancer ADVANCED LUNG cancer patients who took Merck & Co's Keytruda immuno-oncology medicine in a large trial and were previously untreated went longer without their disease worsening and showed a survival advantage over those given standard chemotherapy, the drugmaker said. An independent data monitoring board recommended that the late-stage trial be stopped due to the favourable results, Merck said, thereby allowing patients who were taking chemotherapy to switch over to the company's treatment. Keytruda, which takes the brakes off the immune sys-

36 EXPRESS PHARMA July 16-31, 2016

tem by blocking a protein called PD-1, is already approved for patients who have undergone previous chemotherapy for advanced non-small lung cancer. Patients enrolled in the trial had tumours with high levels of PD-L1, a related protein whose presence may help identify which patients are most likely to respond to Keytruda and similar drugs called checkpoint inhibitors. Merck hopes the new data will allow its injectable drug, which has a list price of about $150,000 a year, to be used earlier as a treatment for the most common form of lung cancer.

Bristol-Myers Squibb Co's approved rival Opdivo is also being tested as a so-called first line treatment for NSCLC, with data expected later this year. Opdivo's studies have enrolled patients regardless of their PDL1 levels, helping assure its wider use and greater sales than Keytruda. John Boris, an analyst with Suntrust Robinson Humphrey, forecast that Keytruda will generate annual sales of $7 billion by 2021. But he predicted Keytruda will have only 25 to 30 per cent of the first-line NSCLC market, while Opdivo commands a 65 to 70 per cent market share.. Reuters

RESEARCH

Researchers find second ‘superbug’gene in US patient The mcr-1 gene makes bacteria resistant to colistin, an antibiotic used to treat multi-drugresistant infections, including carbapenem-resistant enterobacteriaceae or CRE, which US health officials have dubbed a 'nightmare' bacteria SCIENTISTS MAY have identified a second patient in the US infected with bacteria carrying the mcr-1 ‘superbug’ gene, which makes bacteria highly resistant to a last-resort class of antibiotics. The gene is believed to have been found in a sample of E. coli bacteria from a patient in New York. The finding follows the discovery late last month of a patient in Pennsylvania who had a urinary tract infection caused by E. coli that carried the gene. The finding was to be published in Antimicrobial Agents and Chemotherapy, a journal of the American Society for Microbi-

ology. But editors at the journal said they decided to withhold it from publication because the study authors wanted to verify whether the data were accurate. The mcr-1 gene makes bacteria resistant to colistin, an antibiotic used to treat multi-drugresistant infections, including carbapenem-resistant enterobacteriaceae or CRE, which US health officials have dubbed a 'nightmare' bacteria. What is concerning about the mcr-1 gene is that bacteria have the capability to share resistance genes. US officials are worried that the mcr-1 gene may find its

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way into CRE bacteria, potentially creating bacteria resistant to virtually all types of antibiotics. Scientists have been tracking the mcr-1 gene's movement around the globe since it was discovered last year in peo-

ple and pigs in China. The possibility of another US finding of mcr-1 comes as part of a global effort called the SENTRY Antimicrobial Surveillance Program, led by Mariana Castanheira of JMI Laboratories based in North Liberty, Iowa. Researchers tested 13,525 E. coli and 7,481 Klebsiella pneumoniae strains from patients collected last year from hospitals in the Asia-Pacific region, Latin America, Europe and North America. Of these, 390, or 1.9 per cent, were resistant to colistin, and 19 of these isolates tested positive for the mcr-1 gene. These data

are now being checked for accuracy. For the study, samples carrying the gene came from 10 countries and included some from each region. Only one came from the US. It involved a New York patient infected with E. coli whose name and condition were not disclosed. In the first US case, bacteria that carried the 'superbug' gene were resistant to colistin but susceptible to a number of other antibiotics, making the infection treatable. Data pertaining to the second suspected case are being reviewed. Reuters

EXPRESS PHARMA

July 16-31, 2016

RESEARCH

Excess blood triglycerides tied to fracture risk in middle aged women The study suggests that women entering the midlife should take action to lower elevated triglycerides WOMEN AROUND the age of menopause with elevated blood fats known as triglycerides may also have elevated risk of breaking a bone, a US study suggests. Researchers followed more than 2,000 premenopausal women with no history of bone fractures for nearly 15 years. By the end of that time, some women with high triglycerides were more than twice as likely as others to have experienced a fracture. While the study doesn't prove that high triglycerides cause fractures, it 'supports this possibility,' said senior study author Dr Jennifer Lee, a researcher at Stanford University and Palo Alto Veterans Affairs Medical Center in California. "This study suggests that women entering the midlife should take action to lower elevated triglycerides," Lee added. During menopause, as estrogen levels decline, levels of fats in the blood increase over time as part of the aging process. Fracture risk also increases, although it’s not clear if blood fats and bone strength are related, or how, Lee’s team writes in the Journal of Clinical Endocrinology and

Metabolism. To explore this question, Lee and her colleagues analysed data from a large, long-term study of women who were 42 to 52 years old when they were enrolled at seven US sites between 1995 and 1997. At the start of the study, half of the women were at least 46 years old and many were overweight. Three quarters of them had low to normal triglyceride levels. Blood triglyceride concentrations of less than 150 milligrams per

deciliter (mg/dL) are considered normal, while levels from 150 mg/dL to 199 mg/dL are considered borderline high and anything above 199 is too high. After reviewing data from the women’s annual medical exams over the next 13 years, the study team found that 147 women had what's known as nontraumatic fractures – broken bones, but not the result of a traumatic accident like a car crash. About a third of these injuries were fractures of the foot, while

GSK’s lung drug meets late-stage study goals DRUGMAKER GLAXOSmithKline said its experimental combination therapy for a chronic lung problem met the main goal of a late-stage study, allowing the company to apply for marketing of the drug by the end of 2016. The company said

38 EXPRESS PHARMA July 16-31, 2016

the study met its two main goals of significantly improving lung functions in patients suffering from chronic obstructive pulmonary disease on two scales compared to AstraZeneca's Symbicort. GlaxoSmithKline, which is a market leader in res-

piratory medicine, is competing with rivals such as AstraZeneca and Novartis to use three different mechanisms of action in a single inhaler to help open the airways of patients with more severe disease. Reuters

about 16 per cent were broken ankles and 13 per cent were broken wrists. An increase of 50 mg/dL in a woman’s triglyceride levels during one of the annual exams was associated with a 31 per cent increased risk of fractures two to five years later and an overall 11 per cent increase in fracture risk. Women who started out with triglycerides over 300 mg/dL before menopause were also two and a half times more likely to experience fractures by the end of the 13-year study than women who started with levels below 150 mg/dL. Other factors may influence the association between elevated triglycerides and fractures, said Dr. Walter Willett, a nutrition and public health researcher at Harvard University who wasn't involved in the study. "The findings should be interpreted cautiously because triglycerides are a sensitive marker of a bad metabolic state related to lower physical activity, high intake of unhealthy carbohydrates and unhealthy fats, and a prediabetic state," Willett said. Still, an in-

crease in triglycerides is a red flag that lifestyle changes may be needed, he added. "Regular physical activity and healthy diets will lower triglycerides and have many health benefits, including lower risk of fracture," Willett said. At the same time, women may avert fractures by taking steps to prevent falls and other accidents, noted Naila Khalil, a community health researcher at Wright State University in Dayton, Ohio, who wasn't involved in the study. Women can prevent falls by doing exercises to strengthen balance and muscle tone, getting regular eye exams, removing loose rugs from rooms, placing furniture with easy paths to navigate, proper lighting, and supports or rails on stairs and in bathrooms to prevent tripping, Khalil said. To lower the odds of fractures, women should get adequate amounts of calcium and vitamin D, exercise several times a week, and have bone mineral density tests to assess if they should take medications to decrease bone loss, Khalil added. Reuters

RESEARCH

Pfizer,Germany’s Merck begin ovarian cancer trial The 950-patient study will enroll patients with advanced ovarian cancer who have not previously been treated for the disease PFIZER AND German drugmaker Merck said they had begun a late-stage trial of their immuno-oncology drug avelumab in combination with standard treatment for ovarian cancer. The 950-patient study will enroll patients with advanced ovarian cancer who have not previously been treated for the disease, which is diagnosed annually in almost 23,000 American women and has a high mortality rate. Avelumab is a so-called

checkpoint inhibitor, which works by taking the brakes off the immune system. One group of patients in the phase III study will receive avelumab in combination with platinum-based chemotherapy, the current standard of care. Others will receive chemotherapy alone, or avelumab a few weeks after receiving chemotherapy. Rival drugmakers BristolMyers Squibb Co and Merck & Co are developing similar checkpoint inhibitors for a

range of cancers, but have not yet tested them alongside standard treatments in large trials of patients with previously untreated ovarian cancer. In one small early-stage study of Merck's Keytruda, tumour shrinkage was seen in 11.5 per cent of patients with ovarian cancer, without significant safety issues. Ovarian tumours shrank by 15 per cent among patients taking Bristol-Myers' Opdivo in a small trial. Reuters

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Quality in your hands EXPRESS PHARMA

July 16-31, 2016

PHARMA ALLY /AUTOMATION

Getting future ready with automation Irrespective of a significant investment involved in it, the Indian pharma industry has no option but to embrace automation to achieve their global ambitions. By Sachin Jagdale

oday, Indian pharma industry manufactures a range of medicines and a significant chunk of it is exported to various countries across the globe. As per a report by Equity Master, it ranks third in terms of volume and the 13th in terms of value, globally. Whatever so far the industry has achieved been attributed to various factors, of which, automation is perhaps the most significant one. The use of automation is no longer a choice but a compulsion for those who want to leave their footprints in the international markets.

Rapid strides towards automation... In th early days of automation, it was confined to a shift from mere mechanical machines to electro-mechanical devices like motors. However, technological advances have redefined automation and taken it to unprecedented levels. Initially, automation was predominant in the manufacturing processes, however, today it encompasses areas like labs too and continues to expand. Satish Varma, Managing Director, Fermenta Biotech says, “The last few decades have seen concerted efforts across various disciplines in the pharma/ biotech industry with respect to automation. We all are aware that the manufacturing industry has always been the first to embrace automation. This was solely due to its initial apparent merits based on increase in productivity, improvement in quality and moreover minimisation of waste which all led to a significant re-

40 EXPRESS PHARMA July 16-31, 2016

duction in the overall cost. As our industry matured, over the decades, with increased exposure to earlier unknown benefits, more and more disciplines of the sector started adopting automation”. The Indian pharma industry is in a bid to establish itself as a major player in the global

market. Though there are several Indian pharma companies operating globally, the recent years saw Indian pharma’s reputation taking a hit due to the quality concerns raised by regulatory authorities such as the US FDA. Industry experts believe that automation can be one of the tools that can help

douse these concerns and appease the global regulatory authorities. “The increase in stringency of regulation led to a large number of companies switching over to automation as it ensured compliance to guidelines and safety considerations. With biotech products gaining more

importance and an increasing focus on research, the R&D section of the industry have accepted automation to a significant level. The recent advancements in robotics have made the dream of a fully automated laboratory a reality. Laboratory Information Management Systems (LIMS) have seen

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wide acceptance across the industry in recent times. Automation is also being used by local druggists and pharmacies to maintain patient information. It has also helped in reducing drug dispensing time, especially for patients with chronic ailments. Lastly, the problem of spurious drugs has been curtailed by novel automated packaging solutions,” adds Varma. According to Ketan Zota, Director, Zota Healthcare, most successful organisations are rigorous about their processes, manufacturing operations, validation and quality improvement through the use of automated processes.

...yet a lot of ground to cover Western countries have been at the forefront in the invention and implementation of new automations. With changing times, Indian pharma compa-

and more such awareness programmes in universities and other research –academic institutions,” says Mahajan. Varma feels that other industries are more receptive than the pharma and biotech sector when it comes to adopting automation technologies. Highlighting the major deterrents, especially for the smaller players, he elaborates, “It is a well-known fact that our pharma and biotech industry has come a long way with respect to automation, however in comparison to other industries we are still slow paced in embracing it. Highly precise processes or ones with high repetitiveness are excellent candidates for automation. However, lack of expertise, high investment costs with no structured model to evaluate return on investment (ROI) from automation of certain processes and the apparent misperception about the complexity of programming required as well as the

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Though there are several Indian pharma companies operating globally, the recent years saw Indian pharma’s reputation taking a hit due to the quality concerns raised by regulatory authorities such as the US FDA. Industry experts believe that automation can be one of the tools that can help douse these concerns and appease the global regulatory authorities nies are also rapidly adopting automation and adapting to it. However, lack of awareness about the new technologies and scarcity of funds are still holding them back from going full throttle when it comes to automation. Dr Girish Mahajan, Vice PresidentMicrobiology Division, HiMedia Laboratories, says that as far as automation in Indian organisations are concerned, we have kept pace with the global trends in the healthcare sector. “However, when we move to small scale industries, the automation level comes down exponentially. This perhaps will get upgraded only if more and more awareness programmes are conducted by the automation industry. Government funding agencies are facilitating innovative ideas and supporting automation by funding for capex. The automation industry has to move one step ahead to bring more

peripheral investments in infrastructure persist as concerns, especially among small and medium sized pharma companies. They are delaying the adoption of automation in the pharma industry.” Zota identifies a few operational hurdles for the industry. According to him, in the pharma sector technology transfer can take relatively more time compared to other sectors in India. “Newly invented technologies can take a long time to become integral part of pharma production and processes. These technologies tend to become obsolete rapidly in other sectors as compared to the pharma industry. Technology and automation can possibly face huge challenges in the pharma industry as even the slightest error can cause lethal damage and can also affect the overall quality of the product,” explains Zota.

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PHARMA ALLY / AUTOMATION Robo‘tricks’ Every new innovation is making operations more complex in the pharma and biotech sectors. Some tasks are beyond human capability and sometimes extremely hazardous too. According to automation experts, robotic technology is providing answers to these challenges to some extent, especially in laboratories. However, though cash rich pharma companies can afford to have robotic machineries at their units, it is not a viable option for smaller players. Yet, it cannot be denied that robotics is furthering progress in the lifesciences sector. Genomics, particularly gene sequencing has created new opportunities for drug discoveries. Methods like statistical genetics, sequencing, gene expression analysis etc are performed at the laboratory level. Various sensitive samples are handled/ processed in the laboratory for the same. This is where robotics has contributed a lot. Advancements in genomics were hardly possible without the support of robotics. Hiranjith GH, Director, MedGenome, opines, “As the sequencing process developed over time into a routine, one that utilised the same series of steps and the same components at each iteration, implementation of robotics provided scope to revolutionise genomics. For instance, high throughput screening (HTS) employs the use of robotics to do much of the tedious, repetitive work that was previously done by scientists, leaving them with more time to design experiments and analyse data. Robotics in the use of processes like DNA template preparation, reaction assembly, liquid handling, fragmentation and size selection, simplify and standardise sample handling.” He adds, “Devices like oligosynthesizers, DNA shearing, plaque and colony pickers/gridders, template preparation systems, sequencing reaction robotics, and thermal cyclers help in elimination of manual errors, ease of sample tracking (usage of bar codes) and the reproducible nature of the product. Implementation of these robotic devices not only reduce the time and expense of method development and optimisation,

42 EXPRESS PHARMA July 16-31, 2016

The last few decades have seen concerted efforts across various disciplines in the pharma/ biotech industry with respect to automation Satish Varma Managing Director, Fermenta Biotech

The most successful organisations are rigorous about their processes, process control, manufacturing operations, etc through the use of automated processes Ketan Zota Director, Zota Healthcare

If automation has the potential to reduce the cost of medicines then the government should consider giving tax exemption or subsidy to the pharma and biotech companies to automate the processes they also enable a highly enhanced scale of operations”. Varma explains how the benefits offered by robotics outweighs cost involved in its implementation with examples. He says, “Increased efficiency, consistent quality and reduction in overall product cost are few of the obvious benefits that robotics will offer to our industry. The perception of high initial investment needs to be looked at with a different perspective as the implementation of robotics will completely eliminate errors and reduce time in certain aspects of operations viz. packaging. A glaring example is the use of the auto-cartoner which has revolutionised the way tablets and capsules are packed. Another example is in biotech labs where

routine, mundane operations can be done with the help of robotics thus freeing the time of our scientists which can be deployed for more creative and innovative tasks. Simply speaking, in any operation where the cost of error is pretty high to such an extent that even fairly low error rates can have significant impact on the end result, one has to appreciate the benefits of robotics.”

Hurdles to cross Though automation is being deployed to a considerable level, experts unanimously agree over the fact that machines can't replace humans completely. There are still a few processes in the pharma and biotech operations where there is no alternative yet to manual intervention.

As far as automation in Indian rganisations are considered at present we are comparable to abroad in healthcare sector.

Devices like oligosyn thesizers, DNA shearing, plaque and colony pickers/ gridders, etc help in elimination of manual errors and ease of sample tracking of the product

Dr Girish Mahajan Vice President-Microbiology Division, HiMedia Laboratories

“Pharmaceuticals are prone to get degraded if not handled with care or if not stored properly. It can become very difficult to introduce automation where visual analysis, recognition or comparisons with colour changes are required. A small deviation can lead to huge errors. Identification of particles and micro particulate matters are extremely difficult with automated processes. Moreover, automation in clinical research can also be tough despite the implementation of semi-automated devices and computer software,” informs Zota. Varma also reiterates, “Though a majority of operations and critical lab activities can be automated, key important factors like technical managerial decision making, defining and implementing critical success parameters, contingency planning cannot be a completely automated. I feel that automation should complement human innovation and creativity, it should not be considered as a substitute. It may offer various alternatives to solve critical problems but one cannot ignore the ability of human intervention in picking up the right choice which is the best fit for a particular issue at any given time in a specific environment.”

Hiranjith GH Director, MedGenome

Dealing with the cost factor Whether it is manufacturing, buying or selling, cost has always remained a deciding factor in the Indian market. If automation has the potential to reduce the cost of medicines, then the government should consider giving tax exemption or subsidy to the pharma and biotech companies to automate the processes. After all, affordability of medicines to the final consumer is a crucial factor. Varma asserts, “Indeed a major hindrance in accepting atomisation is the initial investment cost. Any efforts towards addressing this issue will definitely help the industry operations.” India is known to produce low cost products. So, if the government encourages and assists local manufacturers to produce automated machinery under the ‘Make in India’ programme, it will also accelerate the pace at which pharma and biotech companies automate their operations. Varma signs off, “Academia – industry partnerships needs to be looked into more specifically to develop cost effective, industry friendly automation solutions.” sachin.jagdale@expressindia.com

PHARMA ALLY

VENDOR NEWS

Videojet receives INTERPHEX 2016 Exhibitor Award Videojet Technologies has received the recognition for Videojet 7510 50-Watt Fiber Laser Marker VIDEOJET TECHNOLOGIES, a global leader in coding, marking and variable data printing solutions, has received the award for the Best Technology Innovation by Pharmaceutical Processing’s INTERPHEX Exhibitor Awards. Videojet Technologies has received the recognition for Videojet 7510 50-Watt Fiber Laser Marker, a laser marking system designed for high contrast marking on high density plastics and metals, including pharmaceutical bottles and aluminum vial caps. Operating at speeds up to 440m/min.,

The INTERPHEX Exhibitor Awards programme was launched in November 2014

this technology delivers better mark quality and has a smaller marking unit, compared to traditional solid state laser systems. “We are committed to designing innovative products that help manufacturers address their evolving industry challenges and regulatory requirements,” said Tim Kearns, Pharmaceutical and Medical Devices Manager, Videojet. “The 7510 laser in particular helps pharma and medical device companies navigate traceability requirements. In addition, its high speed capability and exceptionally large marking window directly address the growing need for increased lines speeds and maximised throughput.” The INTERPHEX Exhibitor Awards programme was launched in November 2014 and recognises INTERPHEX exhibitors excelling across six categories: best in show, best new product/service, editor’s choice, best technological innovation, efficiency champion and biotech innovation. EP News Bureau-Mumbai

Waters collaborates with Singapore’s BTI New strategies to identify cancer markers and probe cancer biology will be developed WATERS CORPORATION announced a joint effort with the Bioprocessing Technology Institute (BTI), a research institute within Singapore's Agency for Science, Technology and Research (A*STAR), to develop new methods of finding cancer markers and elucidating glycosylation pathways that could pave the way for new therapeutic strategies. As part of the research collaboration, Waters and BTI will develop a glycosphingolipid (GSL) head group database containing glucose unit (GU) retention times and collision cross-section (CCS)

values in an effort to compile an experimental library for disease-related GSL glycans together with a glycan/MS spectral library. GSLs are highly complex structures in which glycan head groups are attached to fatty acyl moieties. Analysing their molecular composition involves detailing the sequence, anomericity, branching, and linkage positions of the oligosaccharides as well as their fatty acyl motifs. GSLs are critical for cell growth, interaction, and signalling and alterations to their structure may result

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EXPRESS PHARMA

July 16-31, 2016

PHARMA ALLY in diseases or promote the development of different types of cancer. The analysis of the glycan head groups poses a particular analytical challenge for glycoscience because isomeric structures are not easily differentiated by either liquid chromatography (LC) or mass spectrometry (MS) technologies when used alone.

“Collaborating with Waters will enable BTI to apply its expertise in glycomics to develop analytical methods and a library of information on GSLs that doesn’t yet exist today. This will allow us to probe for potential clinical markers and to provide insights into disease progression and regression following therapeutic interven-

tion. We anticipate our science will advance human health while at the same time address some of the needs of the biopharmaceutical industry,” said scientific lead Dr Susanto Woen, Research Scientist, BTI. “The partnership also allows us to be part of an international glycomics research network pioneering technologies required

to determine the potential association between GSL glycosylation and any phenotypic/genotypic traits in disease or disease states.” “By taking our partnership to a new level, we will empower BTI to further develop novel analytical methods and establish a comprehensive experimental glycan spectral library

for cancer glycobiology focusing on glycosphingolipids. Together, we want to advance methods to study GSL glycosylation in cancer classification and biomarker discovery,” said Dr Jose Castro-Perez, Director – Health Sciences Marketing, Waters Corporation. EP News Bureau-Mumbai

Schreiner MediPharm develops new version of Pharma-Comb SL label The special label design is particularly easy to use on small vials allowing efficient and reliable marking of the medication SCHREINER MEDIPHARM developed a new version of the Pharma-Comb SL (Self-Lifting) label with a starter tab for a leading producer of anesthetics in China. The special label design is particularly easy to use on small vials allowing efficient and reliable marking of the medication while increasing patient safety at the same time. Pharma-Comb labels are speciality labels with one or several detachable parts printed with the most important data. The small vial size posed a special challenge for the new version of the Pharma-Comb SL label. Despite minimal space, the label must contain all important product information, provide room for variable post-printing, and integrate a detachable part to mark the disposable syringe after drawing up the anesthetic. The newly developed solution is based on a three-layered film label. The outer layer offers ample space for important product information and postprinting with the batch number and expiration date. When opening the outer layer, which tightly wraps around the small vial, the detachable part underneath is exposed. Due to its special design, the starter tab of the detachable label part is self-lifting. As a result, the physician or nurse can easily

44 EXPRESS PHARMA July 16-31, 2016

peel it off even with gloves on and mark the syringe after drawing up the medication from the vial. The detachable label contains information about the product name and active ingredients. Additionally, it has two fields for entering the date and time of admin-

istration, and the dose and the initials of the physician or nurse. Due to a special varnish coating of the detachable label it can be inscribed by hand with a variety of pens or pencils. Ann L Merchant, President, Schreiner MediPharm, summarises the label’s benefits and

says, “In daily hospital care settings, medication errors can have severe consequences for the patient. Therefore, clear and reliable marking of the administered medicine, especially in refilling processes, is extremely important. Labels with detachable parts can make an

important contribution here, in order to reliably mark the disposable syringe after drawing up the required dose. Due to the self-lifting starter tab, this can be done in a very simple and convenient way.” EP News Bureau-Mumbai

PHARMA ALLY PRODUCT

Gandhi Automations: Manufacturer of automated rolling shutters

GANDHI AUTOMATIONS, one of Indiaâ&#x20AC;&#x2122;s entrance automation and loading bay equipment company, manufactures rolling shutters certified to ISO 9001 2008 quality management system. This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically-advanced machinery to offer to the customer a well-engineered product. Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters. The research and development team with its extensive know-how and experience are able to produce specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations' manufacturing process right through installation to after sales service. The rolling shutters are ideal for situations where side room is at a premium and security is required. The shutters require very little headroom above the

structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. Gandhi rolling shutters are fabricated of interlocking galvanised insulated and non-insulated, stainless steel, patented aluminum or polycarbonate profiles and patented MS rolling grills. The rolling shutters have been designed according to clients' specifications conforming to IS 6248 and solidly constructed to promote trouble-free operation and long life. Gandhi Rolling Shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement. Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai â&#x20AC;&#x201C; 400064 Off: +91 22 66720200 / 66720300(200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: http://www.geapl.co.in/rollingshutters.html

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PHARMA ALLY/ AUTOMATION

I N T E R V I E W

‘HPTLC analyses dozens of samples simultaneously, quickly and at low cost’ Akshay Charegaonkar, Director, Anchrom Enterprises India, in an interaction with Express Pharma, talks about HPTLC and its benefits

What is HPTLC? The full form of HPTLC is High Performance Thin Layer Chromatography. It’s an instrumental version of Thin Layer Chromatography which is in practice since 1950s and is used for chemical analysis. What is unique about HPTLC? HPTLC produces photographs co-relating to the chemical composition of organic samples. So it is the only ‘visible chromatography.’ It accounts for 100 per cent of the sample, a requirement of cGLP. The results can be evaluated even by a layman. HPTLC analyses dozens of samples simultaneously, quickly and at a low cost. There are numerous other unique features. Why is HPTLC in news today? HPTLC has now been declared the official US and European technique for most fundamental test of identification of materials of botanical origin by using HPTLC fingerprint. The Chinese also use the same. HPTLC is also connected to MS. What is HPTLC fingerprint? It is (for now) photographic image(s) representing the phytochemical composition of samples, mainly those of botanical origin. One sample can produce several different ‘fingerprints’ after

46 EXPRESS PHARMA July 16-31, 2016

derivatisation. The images are recorded in ultraviolet light at 254 or 366 nanometers or in day light.

used, application pattern is defined, chromatography is done at 33 per cent relative humidity after 20-minute saturation etc. Basically, each variable is minimised or eliminated.

Why not use the more popular HPLC technique? HPLC is best used for pure and ‘clean samples which botanicals cannot. The westerners believe in ‘markers’ i.e. the presence and minimum quantity of certain unknown components. Here HPLC or HPTLC can be used. What is the difference between TLC and HPTLC? Today all analysis has to be cGLP compliant. TLC being a purely manual technique fails this criterion. Moreover, in TLC, most parameters are not specified and hence results are unreliable. USP-DSC chapter 203 for the first time ever defines the SOP for HPTLC. The same has been adopted by the Europeans, albeit worded differently. Each and every factor affecting the HPTLC result is controlled in HPTLC. India believes in harmonising with the world’s best quality control practices. India has already adopted the ‘TLC fingerprint’ for identification. How is the US standard operating procedure (SOP) different? The India TLC method is good but it has the limitations of non-cGLP and manual nature. The new SOP has a built in system suitability test, HPTLC pre-coated plates are

HPTLC has now been declared the official US and European technique for most fundamental test of identification of materials of botanical origin by using HPTLC fingerprint. The Chinese also use the same. HPTLC is also connected to MS

How will the HPTLC identification test affect India? A lot of Indian analysts think that USP has no role in their work. This is not true where the world is flat. Firstly, the USP regulations cover not only drugs but herbals, botanicals, dietary supplements and ingredients, neutraceuticals etc. According to the Food Safety Modernization Act 2011 of USA, US FDA inspectors must inspect foreign food suppliers and check for regulatory compliance. In India, where giant pharma companies with deep pockets, experience and expertise have failed to convince the US FDA, what chance does the food exporters e.g: spices exporters have of compliance. Compliance with latest requirements will help export Indian products at premium prices all over the world. What do you see as the future of HPTLC fingerprint? It will be on the label of foods, herbal medicines, phyto pharmaceuticals etc., because customers want genuine products and HPTLC fingerprints guarantee that. EP News Bureau-Mumbai

PHARMA ALLY / AUTOMATION CASE STUDY

Bilcare saves chiller opex with HMX-PCU-F

BILCARE IS AN innovation-led solutions provider that is a global leader in the field of pharmaceutical packaging. Bilcare uses a range of speciality polymer films and aluminum foils to devise solid dosage pharma packaging materials. The company operates out of nine different locations and has five R&D centres spread across Asia, Europe and the US. The company has a strong base of 2,500 customers across 50 countries.

Challenge The Rajgurunagar plant of Bilcare had set up a new triplex laminating line with a raw material storage area. As per the process requirement, the temperature inside the laminator plant room was to be maintained at 26 ± 0°C throughout the year with a RH level of 55 ± 5 per cent. To achieve this, 3 x 100 TR water cooled screw chillers are used with two Air Handling Units (AHUs) with chilled water coils, one with 26,000 CFM and the other with 13,000 CFM. During summer, the fresh air coming into the chilled water AHUs was between 40-45°C. This has led to high TR load on the chillers, resulting in high operating expenditure for these chillers. It was necessary to bring down the temperature of fresh air coming to the chiller, to reduce the operating cost of chillers.

Solution Bilcare discussed the problem at length with the HMX team. On the basis of the weather data available and the TR load

installed, HMX worked out a feasible solution for the company. It was suggested that two fresh air pre-cooling units HMX-PCU-F without blowers should be installed for the two chilled water AHUs. This will help to bring down the temperature of the fresh air substantially being taken in, thus reducing the TR load on the chilled water coils, which will in turn lower the operational expenditure of the air conditioning system installed. Based on the recommendations, Bilcare opted for two HMX-PCU-F, which were installed and commissioned in September 2013.

Result Temperature readings recorded at the exit of both the HMX-PCU-F units clearly establish a significant and consistent reduction in the TR load on the chiller system. Calculation of TR savings based on temperature readings taken at the exit of the HMX-PCU-F units: According to CR Raghu, Head – Maintenance and SHE, “The management is happy and is looking at the possibility of using the HMX units at other locations in the same factory.”

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July 16-31, 2016

PHARMA ALLY / AUTOMATION WHITE PAPER

Benefits of computerised dispensary John Roberts, Technology Director, CI Precision explains the role of a computerised system of dispensing medicines to enhance GMP compliance and reduce the risk of rejected batches during manufacturing of pharma products THE CHALLENGE is to ensure that the correct quantity of an approved raw material of known origin and quality is used during the manufacture of pharmaceutical products. The conventional approach requires a standard operating procedure to be followed by a first person and the details of the weighing recorded with a second operator acting as a checker. With a computerised system, the operator is guided through a predefined sequence of checks and actions and is not allowed to proceed if any of the checks fail. Accurate details of the weighing are recorded automatically, and the system prints barcoded labels for the containers of dispensed mate-

rial, with the operator acting as the checker at every stage to confirm that the details are correct. This process ensures: consistency of dispensing, enhanced GMP and reduced risk of rejected batches. The principal benefits of an MES weigh and dispense module highlighted in this white paper are as follows:

Scope As with any manufacturing sector, pharma production varies considerably in scale. At one end, there are plants producing comparatively large volumes of product; at the other end, there are small-scale operations producing ‘specials’ or

small batches for clinical trials. In some cases, these ‘specials’ operations are factory-based, whereas others are incorporated within hospitals. Whatever the size of the operation, a computerised weigh and dispense system can bring significant benefits.

The dispensing process Accurately dispensing raw material ingredients is a fundamental requirement for the manufacture of high-quality pharma products. Furthermore, it is essential that a manufacturer can demonstrate that secure systems are in place to ensure that only the correct quantity of an approved raw material of known origin and

quality is used. Good Manufacturing Practice (GMP) requires that weighing and measuring is adequately supervised and checked to ensure that the component has been released by the quality control unit after test, the weight or measure conforms to the quantity required by the batch formula, and that each container of weighed material is labelled correctly. When performed manually, the dispensing process requires handwritten records and labels that are produced by a first person and checked by a second person. Separate records are maintained for weighing instrument calibra-

tion and for cleaning of weighing equipment and the weighing area. Although errors occur infrequently in raw material dispensing, they have far-reaching implications in terms of GMP, so systems must be in place to ensure that, as far as reasonably practicable, they do not occur. The elimination of dispensing errors is therefore a prime reason for implementing an MES weigh and dispense module. Common causes of errors and the advantages of a computerised system are listed in the following sections.

Common causes of error Dispense the wrong ingredient

NO.

BENEFIT

SECTION

Barcoded material identification

Dispense the wrong ingredient

Electronic capture of dispensed quantities

Dispense the wrong weight

Electronic verification of the material lot QC status and expiry date

Dispense an invalid lot

A controlled dispensing process (electronic SOP)

Operator errors

Electronic signatures for all significant actions

Operator errors

Enforced cleaning regimes

Contamination

Cost savings due to reduced cycle times, reduced need for a second checker, electronic transfer of stock consumption to the ERP system

Effects of dispensing errors

Recording of health and safety compliance

Further benefits

Better stock control and reduced scope for errors

Further benefits

Software and hardware connectivity

Connectivity and scalability

Scalability into further areas of the manufacturing and packaging processes

Connectivity and scalability

Reporting and trending of product performance

Reporting

48 EXPRESS PHARMA July 16-31, 2016

PHARMA ALLY / AUTOMATION There is the possibility that an operator can accidentally dispense the wrong ingredient by misreading the material name on the stock label. A computerised system uses the barcode on the stock label to identify the material to be dispensed. The barcode enables retrieval of key information concerning the contents of the container. For this reason it is not possible to identify and dispense the wrong ingredient.

pensing the ingredients for an order, so all operators must perform the same steps and dispense the ingredients in the same way ◗ Enables approval points to be configured to apply during particular stages of the dispensing cycle (eg when acknowledging health and safety warnings or reprinting dispensing labels) to ensure that GMP is adhered to at all times.

Contamination Dispense the wrong weight It is possible for an operator to dispense an incorrect raw material quantity. The causes of this are varied, but include: an arithmetical mistake (such as might be the result of dispensing into multiple containers), misreading the balance display, an incorrect potency calculation, an incorrect unit of measure conversion or misreading a quantity from the dispensing instructions (typically by transposing figures - for example, reading 0.912 instead of 0.921).

A computerised system: ◗ Recalculates the remaining quantity on change of dispensed container ◗ Forces the balance to be zeroed and the container tared before each weighing ◗ Enforces the use of calibrated, checked equipment only (e.g. by using daily balance validation checks) ◗ Performs potency calculations and unit-of-measure conversions ◗ Requires the dispensed quantity to be within predefined tolerances before the dispensing may be completed (and the ‘dispensed’ label printed) ◗ Maintains an audit trail of all events

Dispense an invalid lot It is possible for an operator to pick and dispense an expired lot or a lot with an invalid QC status. A computerised system reads the barcode on the stock label and, if the lot has expired or has an incorrect status, warns the operator and does not allow the material to be dispensed.

Operator errors Mistakes can be the result of operators taking shortcuts in the dispensing process or not following the standard operating procedure (SOP). For instance, different operators sometimes have their own dispensing techniques. Mistakes can also occur due to over-familiarity with the SOP. Although periodic audits can be used to ensure SOPs are being followed, there is no guarantee that procedures are being followed in the periods between audits.

A computerised system ◗ Enforces a consistent means of dis-

Contamination of the ingredients dispensed for a product can occur when the incorrect cleaning procedure has been applied following the dispensing of a material. This is especially applicable to cleaning after the dispensing of active materials. A computerised system enforces the cleaning regime, electronic signatures can be used to ensure that the correct procedures are always applied. Specific cleaning regimes may be applied to particular materials/products. And the computerised system may be configured to require a second operator to approve either the cleaning when complete, or each stage of the cleaning process. A log of the cleaning activity is also maintained electronically.

Effects of dispensing errors In general, errors made in the dispensary are identified by the QA department when they qualify the finished product. This mitigates the risk of bad product being released and a subsequent recall. Therefore, dispensing errors tend to result in GMP issues and costly overheads to the manufacturer. Even with a computerised system, however, there is a requirement to audit the processes and for the Qualified Person (QP) to sign-off each batch. This all requires a substantial amount of paperwork to be checked, but a computerised system can significantly reduce the time required to produce and check the relevant reports. Firstly, the data is entered in the computerised system automatically during the weighing process, with no need for any additional inputs from the operator. This means that the necessary reports can be output virtually instantly when required, which is very different from the hours that might be needed to manually create reports for auditors. Furthermore, if the manual report creation process requires data to be handwritten or rekeyed into a spreadsheet or other computer-based package, there is a risk that further errors will be introduced or that figures will be rounded up or down. For the auditor or QP, checking reports is far quicker if they are presented in a consistent way, with all of the data clearly legible.

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July 16-31, 2016

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Strategies for multimedia compliance of extended release tablets with carbopol polymers Sandip Chavan, Associate Manager-Technical Service and Application, Lubrizol Lifesciences, Kedar V Chikhalikar, Associate Head, Technical Service and Application, Lubrizol Lifesciences and Dr Elena Draganoiu, Global Technology Manager for Pharma Solutions, Lubrizol Lifesciences, in this study evaluate the multimedia release profiles of extended release matrix tablets containing carbopol polymers

A KEY aspect for development of extended release tablets is understanding the drug release under various testing conditions, especially the effect of dissolution medium on the release. The purpose of this study was to evaluate the multimedia release profiles of extended release matrix tablets containing carbopol polymers and to develop multimedia compliant formulations of selected model drugs.

Methodology materials Metformin

hydrochloride

50 EXPRESS PHARMA July 16-31, 2016

USP (Wanbury, India), Guaifenesin USP (Synthokem Labs, India), carbomer homopolymers type A (Carbopol 971P NF polymer, Lubrizol Advanced Material, USA), sodium carboxymethylcellulose USP (Sodium CMC high viscosity, Cekol 100000 cellulose gum, CP Kelco, USA and sodium CMC medium viscosity, Blanose 7MF, Ashland, USA), citric acid monohydrate (citric acid) and sodium citrate (Merck, India), corn starch USP NF (Maize starch extra white, Roquette, USA), methacrylic acid copolymer type C USP NF (Eudragit

L30D and Eudragit L100 55, Evonik Industries, Germany), colloidal silicon dioxide USP NF (Aerosil 200 fumed silica, Evonik Industries, Germany), magnesium stearate USP (Ferro, USA), hypromellose type 2208 of low viscosity K100 LVCR (hypromellose K100 LVCR, Benecel K100 LVCR, Ashland, USA), hypromellose K4M (Metolose 90SH-4000SR USP, ShinEtsu Chemical Co, Japan), hypromellose E6 (Pharmacoat 606 USP, Shin-Etsu Chemical Co, Japan), sodium alginate low viscosity (Protanal CR 8133, FMC Biopolymer, USA)

and sodium alginate high viscosity (Keltone HVCR, FMC Biopolymer, USA). Methods Two highly soluble, high dose drugs with pH independent solubility were selected as model drugs for the study: metformin hydrochloride (freely soluble in water; dose 500 mg/tablet) and guaifenesin (soluble in water; dose 600 mg/tablet) extended release matrix tablets of metformin hydrochloride and guaifenesin were manufactured containing 10 per cent and 20 per cent.

Carbopol 971P NF polymer by aqueous granulation process. Additional formulations containing combinations of Carbopol polymers with other co-ingredients were evaluated in order to improve f2 factor. The co-ingredients were selected based on their chemistry, suitability for oral administration (presence in the US FDA Inactive Ingredients Database) and potential to act synergistically with Carbopol polymers (See Table 1). The following classes of ingredients were selected: â&#x2014;&#x2014; Cellulosic polymers like hypromellose and car-

PHARMA ALLY / AUTOMATION

boxymethylcellulose sodium. ◗ Non-cellulosic polymers such as Eudragit L100 55, Eudragit RSPO and sodium alginate. ◗ Buffers for modulation of micro-environmental pH like sodium citrate and citric acid. ◗ Diluents such as maize starch and dicalcium phosphate In the case of guaifenesin, a different formulation approach was also tested: coating of the matrix tablets

with an enteric film of Eudragit and hypromellose as a pore former. The release profiles were tested in three dissolution media 0.1N hydrochloric acid, pH 4.5 acetate buffer USP and pH 6.8 phosphate buffer USP) and the f2 similarity factors (similarity between dissolution profiles in different media) calculated.

Results Metformin hydrochloride and guaife-

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July 16-31, 2016

PHARMA ALLY / AUTOMATION nesin ER tablets had acceptable physical properties (mechanicalstrength 20 – 25 kP,

friability less than one per cent). The extended release matrix tablets of metformin

hydrochloride and guaifenesin manufactured with 10 per cent and 20 per cent Carbopol

971P NF showed faster release in 0.1N HCl than the other two media.

Metformin hydrochloride 500 mg ER tablets with Carbopol 971P NF polymer: Multimedia dissolution compliance was achieved for Metformin hydrochloride extended release tablets formulated with combinations of: ◗ Carbopol polymer and Hypromellose K100 LVCR (ratio 2:1) - Fig. 1 ◗ Carbopol polymer and Hypromellose K4M (ratio 2:1) (See Figure 2) ◗ Carbopol polymer and Sodium CMC high viscosity (ratio 4:1) - (See Figure 3) ◗ Carbopol polymer and Sodium alginate low viscosity (ratio 2:1) - (See Figure 4) ◗ Carbopol polymer and Maize starch (ratio 1:1) (See Figure 5) ◗ Carbopol polymer and Sodium citrate (ratio 4:1) (See Figure 6) The faster release in 0.1N HCl from tablets containing Carbopol polymers has been controlled by the synergistic combinations with co-ingredients that favour the hydration process. Guaifenesin 600 mg ER tablets with Carbopol 971P NF polymer: Guaifenesin release from tablets formulated with 20 per cent Carbopol and coexcipients is shown in Figure 7 – 9. The following combinations provided multimedia compliant dissolution with calculated f2 factor above 50: ◗ Carbopol polymer and hypromellose K100 LVCR (ratio 2:1) – (See Figure 7) ◗ Carbopol polymer and hypromellose K4M (ratio 2:1) – (See Figure 8) ◗ Carbopol polymer and Sodium alginate low viscosity (ratio 2:1) – (See Figure 9) Similar to metformin hydrochloride, the synergistic combination of Carbopol polymers with hydrophilic matrix forming excipients (hypromellose K4M, hypromellose K100 LVCR and sodium alginate low viscosity) at ratio 2:1 resulted in matrix tablets efficiently controlling the drug release in the three media. Guaifenesin release from tablets formulated with 10 per cent Carbopol polymer and 10 per cent hypromellose K4M

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July 16-31, 2016

PHARMA ALLY / AUTOMATION

have shown f2 factor >50 in the three media. An alternative strategy of a porous enteric coating over matrix tablets was also successful in providing multimedia compliant release - (See Figure. 10). The tablet cores containing 10 per ent Carbopol polymer were coated with a porous enteric layer consisting of Eudragit L30D and hypromellose E6 (1:1) at three per cent weight gain.

Conclusion The study demonstrated development of multimedia compliant extended release matrix tablets of Metformin HCl or guaifenesin by using synergistic combinations of Carbopol 971P NF polymer and co-ingre-

dients. The findings from this study may be extended to other drugs on a case to case basis. Carbopol is a registered trademark of The Lubrizol Corporation, USA. Protanal and Keltone are registered trademarks of FMC Biopolymer, USA Cekol is the registered trademark of CP Kelco US Inc, USA Benecel and Blanose are registered trademarks of the Ashland Corporation, USA Eudragi and Aerosil is the registered trademark of Evonik Industries, Germany Metolose and Pharmacoat are the registered trademark of Shin-Etsu Chemical Co Ltd, Japan.

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July 16-31, 2016

PHARMA ALLY / AUTOMATION VALUE ADD

Malvern Instruments: Refining biotherapeutic formulation

DR MICHAEL CAVES, India Business Development Manager, Malvern Instruments

Dr Michael Caves, India Business Development Manager, Malvern Instruments, elaborates on optimising the efficiency and quality of biotherapeutic formulation

MOST BIOMOLECULES are only slightly stable under the ambient conditions that they have evolved to work under. Since the living entities that create these natural molecules require them to be broken down quickly when they are not needed, it is very important that this is the case. However, when we are designing biopharmaceuticals and vaccines to be stored over long periods of time we must ensure their stability without having a major effect on the inherent structure (and therefore efficacy) of the molecule itself. We do this through formulation. Though protein formulation is a well-studied field, stretching back into the early 20th century, understanding of how biotherapeutics are affected by various excipients is still relatively unpredictable. Arginine, a muchused inhibitor of protein aggregation, for instance, is known to have a deleterious effect on the structural stability of certain proteins. Whatever the nature of the biomolecule (hormone, mab, vaccine, enzyme etc.) being developed it is important that the stability of the intended formulation is fully understood prior to clinical trials and scale-up, at which point the quantity of sample available for testing may be very low and the number of formulations requiring analysis very high. Stability studies are also required for biocomparability studies, regulatory approval and batch release, studies that require accurate and repeatable measurements to be made.

Preformulation With this in mind, Malvern offer an orthogonal approach to stability studies, with different

54 EXPRESS PHARMA July 16-31, 2016

kinetics measurement. Detailed spectra allow analysis of tertiary structure and quantification of secondary structure changes. Zetasizer Helix provides a comprehensive understanding of the causes of biopharmaceutical instability, allowing intelligent formulation design and increasing the quality and efficiency of biotherapeutic development.

Summary The Viscosizer TD – high-throughput formulation screening under storage conditions using minute quantities of sample

methods targeted at different stages of the development pathway. The Viscosizer TD, for instance, is used early in the preformulation stage where the number of samples that need analysing are large and the sample volume available is often low. Innovative microcapillary technology allows viscosity and Taylor Dispersion Analysis. Viscosity analysis gives assessment of the injectability of the drug, in addition to stability(1), whilst Taylor Dispersion Analysis gives direct measurement of the presence of aggregates (through absorbance-based size analysis). Perhaps most importantly, Taylor Dispersion Analysis also measures the dynamic virial coefficient of a protein formulation, a measure of the propensity of a formulated protein to aggregate(2). The Viscosizer TD therefore presents an ideal means of high-throughput analysis of large pre-formulation matrices under storage conditions (measurements can be made at temperatures from 4 – 40 °C) using small volumes of precious sample (only 40 nl of sample is consumed by Taylor Dispersion Analysis). High measurement repeatability and accuracy also

makes the technique valuable to biocomparability, with the absorbance-based nature of the measurements eliminating the interference from formulation components and large particulates often seen with light scattering methods.

Refining your formulation Later on in the development pathway, where more sample is available and a direct measure of thermal stability is required, Differential Scanning Calorimetry (DSC) is the gold standard. The technique involves ramping the temperature of a formulation in order to measure the denaturation of the biotherapeutic at elevated temperature. DSC is easily automatable, requires no sample modification and measures thermodynamic change – a universal property common to all protein conformational changes. Malvern’s Microcal VPCapillary DSC system performs comprehensive stability characterisation for 50-plus samples per day, with use of a tantalum cell eliminating interactions between the formulation and the cell and maximising the signalto-noise ratio. Malvern’s Micro-

cal DSC range gives an ideal means of stability-based formulation screening, allowing efficient development of stable formulations. The information-rich nature of Microcal DSC measurements makes the technology ideal to biocomparability testing also, particularly for complex biomolecules like mabs. Each domain of such proteins gives a signal, creating a thermal stability fingerprint that is ideal for assessing the similarity of, for instance, biosimilar formulations to the innovative medicine.

Understanding your formulation The necessity of understanding the causes of them is underlined by the increasing implementation of Quality by Design (QbD) precepts throughout the industry. With QbD in mind, Malvern has combined Dynamic Light Scattering (DLS) and Raman Spectroscopy, giving a comprehensive assessment of both aggregation and conformational changes in a single instrument – Zetasizer Helix. Since both measurement types are performed in an interleaved manner on the same sample, the instrument is ideal for performing

The complexity of proteins and the unpredictability of the effect of excipients on their stability makes an orthogonal approach to stability-testing essential to preformulation, formulation and biocomparability studies. Viscosizer TD detects early aggregate formulation and measures the propensity of a formulated protein to aggregate under ambient conditions (using extremely low quantities of sample), whereas Microcal DSC asses the structural stability of proteins during thermal stress. Along with the unique information provided by Zetasizer Helix, these techniques give an ideal platform for formulation characterisation at every stage of biotherapeutic development, from discovery to batch release. References (1) MAbs. 2015 Jan-Feb; 7(1): 77–83 (2) Anal. Methods, 2016, 8: 386-392 Contact details Malvern Aimil Instruments Naimex House, A-8 Mohan Co-operative Industrial Estate, Mathura Road, New Delhi – 110044 Tel : 011-30810244 Fax : 011-26950011 Email : delhi@aimil.com

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SOP for using HPTLC (USP & PhEur)

Reference - USP (Chapter 203) & PhEur (Chapter 2.8.25)

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Step 3: CHROMATOGRAPHY DEVELOPMENT Default parameters Chamber saturation - 20 min. Disposable paper lining – Yes RH – 33% Development distance – 70mm Electronic Mobile Front Detector preferred. Auto Development Chamber – Preferred Dry the plate asap, in a vertical position, with cold air

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Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

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July 16-31, 2016

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Kleantech Engineering Systems launches largest manufacturing for cleanroom technology Kleantech has in-house capability for designing and executing any size of projects in a short period KLEANTECH Engineering Systems, established in 2008, is a fully stabilised company and has completed 100 pharma projects for formulation, bulk drugs and API, etc. It has also executed projects for electronic industries, food industries, etc. Kleantech has an in-house capability for designing and executing any size of projects in a short period. Kleantech Engineering Systems has recently launched Indiaâ&#x20AC;&#x2122;s largest manufacturing unit for turnkey air conditioning, refrigeration, ventilation and bio-cleanroom applications in Karnataka, 110 kms from Hyderabad International Airport. The company is into the manufacturing of cleanroom equipment and all types of cleanrooms, sandwiched type of prefabricated panels, doors, air handling units, Dx units, cold storage, SS cleanroom furnitures, electrical control panels, HEPA Filters and pre filters, fine filters, microvee- filters. All equipment and accessories are made in the factory and since there is no relying on other suppliers, hence the execution of project becomes more faster. The company is also instrumental in providing services for cleanrooms. The products and services meet the requirements of food, pharmaceutical and electronic industries. Further, it also provides turnkey solutions for clean room applications at its current manufacturing units, located at Vasai (E) Palghar (Maharashtra) and Karnataka. The company is also into designing and commissioning of cleanroom HVAC projects, modular clean room systems

88 EXPRESS PHARMA July 16-31, 2016

Kleantech Engineering Systems has a large network of clients in India and abroad. Apart from India, its clients are located in North Africa, East/ Middle Africa, South/ West Africa, the Middle East and South America

for pharma and other allied industries. Backed by a team of professionals, Kleantech Engineering Systems also assist or clients in the preparation of facility layout and process equipment validation. Support of diligent professionals and high-tech amenities help to provide most reliable solution to its clients. Currently, the company has an annual turnover of ` 40-50 crores and it is expecting a 50 per cent growth in 2016-2017. The products and services are reliable and are availed by electronic, food and pharma industries. Kleantech Engineering Systems is a client-centric organisation. Kleantech Engineering Systems has a large network of clients in India and abroad. Apart from India, its clients are located in North Africa, East/ Middle Africa, South/ West Africa, the Middle East and South America. Due to a continuous support of its professionals, the company is expecting an exponential growth in the near future. The manufacturing units have large production capacity and helps in meeting the bulk requirements of its clients. Today, the cleanroom technology and HVAC and its built products have witnessed an increasing and continuous growth all over the world. Contact details Kleantech Engineering Systems, Tel: +91 0250 2458869 / 2458870 Mob: +91 97642 81212 / 90048 35550 E mail: info@kleantecheng.com kleantech08@yahoo.com www.kleantecheng.com

PHARMA LIFE

Optimising opportunities in pharma sector Gopal Nair, Director, ISPE India Affiliate, elaborates on the challenges in the Indian pharma sector and details strategies to make pharma organisations smart

ndian pharmaceutical industry is truly at cross roads today. On one side, the domestic prices are being regularly cut by the government thereby reducing the profit margins. On the other hand, the more profitable export market has seemingly suddenly thrown up hurdles in the form of tougher regulatory action thereby delaying or stopping exports. The important aspect that seems to be missed is that drugs are being made for the patient whether domestic or foreign and as such the ‘Standards’ of these drugs should not differ! And here lies the nub. Many in this industry still find it difficult to grasp that these ‘ standards’ like meticulous documentation or OOS investigations, to name just two, really contribute to product quality! The message now is loud and clear – If you want to stay in this game you better comply with all standards. No one wants to be taken out of play or be ‘eliminated’ from the game. Pharmaceutical operation is not a game but is serious business; it is a business of wellness, of patient’s safety and one of compliance to standards. So how ‘smart’ is your operation? How ‘wired’ is your operation? I am not, here, discussing concealed wiring! I am asking these questions: Have you got ‘smart’ equipment? Smart Processes? Smart Operators?

Smart Suppliers? And Smart Distribution? Having a network of connected devices in pharma manufacturing facilities means remote access to equipment, proactive maintenance of equipment based on actual logs and analytics, realtime plant floor visibility, the ability to recognise and respond to compliance issues immediately, and the ability to monitor and control serialisation. The resulting analytics from these connected devices can be used to avoid compliance issues and hence audit failures. But perhaps I am getting ahead of myself. So let me start with our (Indian pharma’s ) problems. India’s pharma sector has seen unwavering growth in the past few years, going up to $23 billion in 2012, from $23 million in 2002. Various industry reports suggest that the pharma sector in India has been growing consistently at the rate of 13-14 per cent every year since the last five years. According to the consulting firm McKinsey & Company, India’s pharma sector will touch $55 billion by 2020 (:http://info.shine.com/industry/pharma/2.html) Tighter scrutiny of Indian manufacturing sites by US drug regulators, increased competition and weaker currencies in key markets such as Africa and Russia are likely to slow down the growth of Indian pharma exports over the

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next four years, says a new study. The annual growth rate in pharma exports may almost halve to 7.98 per cent by 2020 from 14.77 per cent CAGR during 2010-2014, according to a joint report on Intellectual Property Rights (IPR) by TechSci Research and industry chamber Assocham. The growth rate for exports of pharma products from India to the US is definitely declining, mainly due to increasing US Food and Drug Administration (FDA) scrutiny on the quality of pharma products coming from drug manufacturing

plants located in India “In order to boost the growth rate of exports to the US, Indian companies will need to leverage their compliance to US FDA regulations,” the report added. Closer to home, the domestic sector registered the slowest monthly sales growth in March for financial year 2015-2016, primarily hit by the government’s recent decisions to ban 344 combination drugs and bring nearly 800 essential medicines under price control. AIOCD AWACS estimated that the ban could result in the loss of ` 3049 crore to the Indian pharma industry annually. In an interview with a leading financial daily, DG Shah, Secretary General of Indian Pharmaceutical Alliance, had this to say: Problems for Indian pharma companies started a year-anda-half ago. FDA issues keep on cropping up now and then. How do companies tackle this? Why is it happening? DG Shah: These large companies have come together and formed a quality forum and we are taking the best available consultants in the world including the regulators both MHRA/EDQM and US FDA to address these issues. There are several industries we need to look at. Take steel, automobile, airline, which have been ranked as complying with the best quality standards, so it is not that that we do not have capability or we

cannot do it. It is a question of focus and that focus has come back about 12 months ago and the results will take some more time. So, I am absolutely confidant and determined we will resolve these issues. For some companies it maybe earlier, for some it may take a little longer. But the market is the US and nobody would want to leave that market.” This year itself, three Indian companies got US FDA warning letters - IPCA Silvasa on Jan 29 2016; Emcure Pune on March 3 2016; Poly Drugs Sewri on April 14 2016 Each one for GMP violations w.r.t data entry & documentation. So three issues are clear ◗ (Major) market is abroad; ◗ We must leverage our compliance to the US drug regulations ◗ We still have issues of compliance in terms of data entry and documentation. This then brings me back to the first question: How wired is your factory? How smart is your operation? The issues of ‘Data entry’ have been given a euphemistic catchy phrase, by the regulators, calling it ‘Data Integrity.’ Issues of data integrity can happen due to two reasons; ◗ Due to deliberate manipulations ◗ Due to human error. This article deals primarily with the second reason and how this can be mitigated. Human beings will make

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July 16-31, 2016

PHARMA LIFE errors and since we are in the business of making life saving drugs ‘human error’ if uncorrected can endanger lives! The only manner in which we can minimise and eliminate errors is to automate as much as possible. There is a great fallacy in our thinking that labour is cheap and that automation is expensive. In a globalised supply chain scenario, we have not fully grasped the real cost of failure. In the best case scenario, it could be temporary suspension of supplies and drop in profit margins; in the worst case scenario it could be global fines in millions of dollars, collapse of reputation or even bankruptcy and jail terms if drugs are found harmful to patients. Speed to market with precision is critical. Delayed time to market or reduced time in market erodes strategic positioning and profitability. So let me introduce to you what I call ‘The Technology Ladder.’ It looks something like this: You can start at the bottom of the ladder and make sure that you progressively go up the ladder. As depicted in the picture above starting from a simple transfer of liquid by opening a valve to deliver the liquid into a container manually, to the middle rung of having a PLC control the time of transfer, volume/weight of transfer and capture the process electronically as a record. The next rung is the top most and represents the ultimate ‘smart’ factory with a network of connected devices in the manufacturing facility with remote access to equipment, capability of proactive maintenance of equipment based on actual logs and analytics and realtime plant floor visibility. Today, there are technologies available that will enable you to retrofit electronic equipment into your old process and have them wired thereby eliminating data integrity issues stage by stage. If you are putting up a new facility in a green field site then it certainly makes for good business sense to start higher

90 EXPRESS PHARMA July 16-31, 2016

THE TECHNOLOGY LADDER

up on the technology ladder. If you are not at the top of the technology ladder make sure you are not on the bottom most rung either. Humans are fallible and errors are to be expected, even in the best organisations. When a deviation occurs, the important issue is not who blundered, but how and why did the defenses fail? Some of the hidden costs to having an untrained and/or unskilled workforce can include lost production time, inefficiencies,

missed deadlines, rework, and injuries and poor customer retention. IT Companies like APPLE, GOOGLE etc. have full time in-house training set up. GSK had professors from Duke's University, USA, who went to Singapore to train Asia Pacific staff. Remember that training hours/budget are also one of the inspection issues by regulatory authorities. Electronic Batch Record Systems (EBRS) are a perfect solution for the pharma indus-

try. Through a user-friendly Graphic User Interface (GUI), EBRS can provide an efficient way for automatic capturing of data, exchange of batch information, batch production management, report generation and for accuracy of operators. EBRS would also provide a central storage of data to maintain data security and integrity. By providing functionality for application security, audit log generation, and eSignature capture, EBRS

would ensure that the system becomes completely compliant with the 21 CFR Part 11 regulations. When the US FDA audit your operation aggressive data experts hunt for common DI deficiencies, including lack of ◗ GMP knowledge ◗ Understanding regulatory expectations ◗ Management interest in compliance reporting, ◗ Escalation of problems ◗ Continuous improvement techniques, ◗ Mature QA oversight, ◗ Strong electronic record controls. In today’s regulatory environment, GMP and DI is expected from the entire pharma supply chain. This includes companies responsible for clinical trials, research, manufacturing, and distribution. For the US FDA, ‘import alerts’ and delaying review of new NDAs and ANDAs are the tools of choice to enforce compliance. Remember that for these auditors you are guilty until proven innocent. Imagine a system such as the one depicted below. Here the operations from order placement, receipt, sampling / testing, issue to manufacturing, actual processing, again testing and finally into the warehouse for distribution is all wired and captured electronically. In conclusion, I would like to quote some famous personalities – starting with Archimedes who said, Give me a place to stand and with a lever I will move the whole world. (Archimedes 12th Century.) The second quote is from J F Kennedy who said: My fellow inhabitants of this planet: Let us take our stand here in this Assembly of nations. And let us see if we, in our own time, can move the world to a just and lasting peace. (John Fitzgerald Kennedy 1917-1963) Followed by own plea: “My Fellow Colleagues of this Industry: Let us take a stand at our workplace. And let us see if we, in our time, can move this industry to one of lasting compliance.”

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