VOL 16 | ISSUE 08 | MARCH 2018 | MUMBAI | TOTAL PAGES 60 | ` 150
www.pharmabioworld.com PHARMA BIO WORLD VOL 16 ISSUE 08 MARCH 2018 MUMBAI TOTAL PAGES 60 ` 150
Pharma Packaging & Logistics BioPharma World Expo 2019 20-23, February 2019 Venue: Bombay Exhibition Centre, Goregaon (East), Mumbai, India
Do you know about weights calibration? METTLER TOLEDO is the world's leading manufacturer of weighing instruments and significant supplier of weights, weights sets and related weight calibration services.
· · ·
Accurately calibrated weights are at the base of accurate weighing results. Balances should always be checked with reference weights you can rely on and trust. The Calibration Services cover the reporting of convention mass, expanded uncertainty and traceability in accordance with ISO/ IEC 17025:2005 requirements.
Mettler-Toledo India Pvt. Ltd. introducing Mass Calibration Laboratory(MCL) for calibration of weights/ weight box. Benefits:
· · · ·
Accredited by NABL with accreditation certificate no. C-1477 MCL meet or exceed ISO/IEC 17025, FDA, GMP and requirements of nuclear industry. Reference Standard weights with expanded uncertainty (1/5th) of MPE of E1 accuracy class of weights. Door to door logistic service with insurance on transit damage
For more on Weights Calibration Services Call Toll free No. 1800 22 08884 / 1800 10 28460 Mail us at mclindia@mt.com www.mt.com/service
18 x 24 cm
PHARMA BIO WORLD R.N.I. No.: MAHENG/2002/8502 Chairman
Maulik Jasubhai Shah
Publisher & Printer
Hemant K. Shetty
Chief Executive Officer
Hemant K. Shetty
EDITORIAL Editor
Mittravinda Ranjan (mittra_ranjan@jasubhai.com)
Editorial Advisory Board
Ajit Singh, Jai Shankar, Dr Narges Mahaluxmivala, Dr Prabuddha Ganguly, Dr Satish Ravetkar, Utkarsh Palnitkar
Feature Writer
Mahesh Kallayil (mahesh_kallayil@jasubhai.com)
Design Team
Arun Parab, Shankar Joshi
Marketing Co-ordinator
Brenda Fernandes
Subscription Team
Dilip Parab
Production Team
V Raj Misquitta (Head), Arun Madye
INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
VOL. 16 | NO. 08 | MARCH 2018 | MUMBAI | ` 150
PLACE OF PUBLICATION
Jasubhai Media Pvt Ltd 210, Taj Building, 3 rd Floor, Dr. D. N. Road, Fort, Mumbai 400 001, Tel: +91-22-4037 3636, Fax: +91-22-4037 3635
SALES General Manager, Sales : Amit Bhalerao (amit_bhalerao@jasubhai.com) Prashant Koshti (prashant_koshti@jasubhai.com) MARKETING TEAM & REGIONAL OFFICES Mumbai
Godfrey Lobo / V Ramdas 210, Taj Building, 3rd Floor, Dr. D. N. Road, Fort, Mumbai 400 001 Tel: +91-22-4037 3636 Fax: +91-22-4037 3635 E-mail: godfrey_lobo@jasubhai.com, v_ramdas@jasubhai.com
Ahmedabad
Godfrey Lobo / V Ramdas 64/A, Phase 1, GIDC Indl Estate, Vatva, Ahmedabad 382 445 Tel: +91-79-4900 3636 / Ext:627, Fax: +91-79-25831825 E-mail: godfrey_lobo@jasubhai.com, v_ramdas@jasubhai.com
Vadodara
Godfrey Lobo / V Ramdas 202 Concorde Bldg, Above Times of India Office, R C Dutt Road, Alkapuri,Vadodara 390 007 Tel: +91-79-49003636/627, Fax: +91-79-25831825 E-mail: godfrey_lobo@jasubhai.com, v_ramdas@jasubhai.com
Bengaluru
Princebel M Mobile: +919444728035 E-mail: princebel_m@jasubhai.com
Chennai / Coimbatore
Princebel M / Yonack Pradeep 1-A, Jhaver Plaza, 1 st floor, Nungambakkam High Road, Chennai 600 034 Tel: +91-44-43123936 Mobile: +919444728035, +919176963737 E-mail: princebel_m@jasubhai.com, yonack_pradeep@jasubhai.com
Delhi
Priyaranjan Singh / Suman Kumar 803, Chiranjeev Tower, No 43, Nehru Place, New Delhi – 110 019 Tel: +91-11-4674 5555, Fax: +91-11-2642 7404 Mobile: +919818148551 E-mail: pr_singh@jasubhai.com, suman_kumar@jasubhai.com
Hyderabad
Princebel M / Sunil Kulkarni Mobile: +919444728035, +919823410712 E-mail: princebel_m@jasubhai.com, sunil_kulkarni@jasubhai.com
Kolkata
E-mail: industrialmags@jasubhai.com
Pune
Sunil Kulkarni Suite 201, White House, 1482, Sadashiv Peth, Tilak Road, Pune 411 030 Tel: +91-20-24494572, Telefax: +91-20-24482059 Mobile: +919823410712 E-mail: sunil_kulkarni@jasubhai.com
Single Copy Price: ` 150/-, Annual Subscription: ` 1530/-, Foreign: US$ 180
Jasubhai Media Pvt Ltd Registered Office: 26, Maker Chambers VI, 2 nd Floor, Nariman Point, Mumbai 400 021, INDIA. Tel.: +91-22-4037 3737 Fax: +91-22-2287 0502 E-mail: sales@jasubhai.com
Printed and published by Mr Hemant K. Shetty on behalf of Jasubhai Media Pvt. Ltd., 26, Maker Chamber VI, Nariman Point, Mumbai 400 021 and printed at The Great Art Printers, 25, S A Brelvi Road, Fort, Mumbai 400 001 and published from 3rd Floor, Taj Building, 210, Dr. D N Road, Fort, Mumbai 400 001. Editor: Ms. Mittravinda Ranjan, 3rd Floor, Taj Building, 210, Dr. D N Road, Fort, Mumbai 400 001.
4 ◄ March 2018
Pharma Bio World
08.
INTERVIEW A New Approach to Oral Drug Delivery System - Dr Anwar Daud, Managing Director, Zim Laboratories Limited,
16.
FEATURES Indian Pharma Packaging Industry: The Need to Unlock Untapped Potential - Aparna Balasubramanian, Senior ConsultantSathguru Management Consultants, and Hansini Mutte, Senior Consultant, Sathguru Management Consultants
08 22.
Packaging and Labelling of Pharmaceuticals and Nutraceuticals - Rohini S, Food Scientist, NutriParadise Foods
32.
Emerging Trends in Biosimilars - Dr Sudheer Balaraju, Head - Medical & Safety, Navitas Life Sciences and Swetha R Khokale, Head Project Management – APAC, Navitas Life Sciences
34.
Embracing Digital Transformation to Enhance Insight and Accelerate Discovery - Gary Palgon, Vice President of Healthcare and Life Sciences Solutions, Liaison Technologies
16 36.
Product Packaging and Labeling - Shruti Kumbla, Senior Nutritionist, Pristine Organics Pvt. Ltd
26.
CASE STUSY Cutting-edge Technology can Bridge the Gap between Strategic Vision and Operational Reality in Pharma Logistics - V Raju, Vice President - Contract logistics – Chemical, Pharma & Food Sector, Avvashya CCI logistics Private Limited
32 44. 46.
NEWS UPDATE Press Release Pharma News
47. 56.
CORPORATE AFFAIRS Products Events
57. 58.
BACKYARD Book Shelf Ad Index
34 Next Issue Focus: Excipients
6 ◄ March 2018
Pharma Bio World
interview
Dr Anwar Daud
A New Approach to Oral Drug Delivery System
8 ◄ March 2018
Recently, oral disper sible films are gaining interest as an alternative of orally disper sible tablets and other conventional orals. The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for a d d i t i o n a l l i q u i d . T h i s c o nve n i e n c e provides both a marketing advantage and increased patient compliance. Dr Anwar Daud, Managing Director, Zim Laboratories Limited, in an exclusive interaction with Mahesh Kallayil, talks about market for Thin Film Drugs in India, its advantage over traditional dosage forms and muc h more.
As a leading player in Thin Film Drug manufacturing, how do you see Indian market for Thin Film Drugs maturing? How do you compare it with other international markets? The opportunity for oral dispersible films as a simple replacement for orally dispersible tablets and other conventional orals is by itself a huge opportunity considering that about ` 35,000 Cr of the present Indian pharmaceutical market consists of oral products with single dose less than 100mg. The simple advantage of differentiation in a crowded branded generics market facing pricing pressures coupled with “greater convenience” to the patient is likely to lead to the rapid growth of this dosage form for the next 6-9years. The intermediate to long term acceleration in growth would come from more sophisticated applications such as sub-lingual/
transmucosal absorption. We have projected a rapid growth phase of the oral thin film market. Internationally, oral thin film has developed in two different directions – in pharmaceutical segment as well as in the nutraceutical segment. Both have large potential for business and growth. The pharmaceutical segment will grow based upon the opportunity available, regulatory constraints imposed by the various licensing authorities, ability for the dosage form to serve as a non-infringing alternative to chemical entities coming off-patent and ability of the dosage form itself to enable oral sublingual and transmucosal absorption of small as well as large molecules. Secondly, there are large number of nutraceutical products available internationally. Pharma Bio World
Customized Vacuum Technology Vacuum technology plays a vital role in many chemical and pharmaceutical processes. Robustness, reliability and energy consumption are now more important than ever. With energy savings of up to 20 % and reduced operating costs of up to 60 %, Busch vacuum technology sets new standards. Find out more about economical vacuum generation from Busch. Contact us.
Busch Vacuum India Pvt Ltd. +91 (0)124 421 2171 l sales@buschindia.com www.buschindia.com
interview What are the biggest bottlenecks in your view for the OTF manufacturers in India to compete at the global level? What are the challenges for Indian companies? The technology to manufacture oral thin films is new and very few companies have developed know-how and expertise on the manufacturing process to enable consistent commercial manufacturing of products with acceptable quality. Comparatively few products are available in the market compared to the number of products which are possible. The global market for orally dissolving products is 11.40 billion USD and is expected to reach 27 billion USD by 2025. The other big bottlenecks besides lack of available expertise are incomplete understanding of the regulatory requirements by manufacturers as well as regulators, with reference to plant, equipment, processes, establishment of Bio-Equivalence etc and risk aversion by established brand leaders large to switch their conventional products to this innovative dosage form. The challenge for Indian companies further consist of producing differentiation through films at the same time keeping the products affordable and select the right products from view point of regulatory requirements and real patient convenience.
dysphagic, mentally challenged and the bed ridden have special needs that require an alternative to swallowing. Orally dissolving films are thin films which when kept on the tongue dissolve almost instantaneously. Unlike tablets and capsules these thin films do not require water for their administration and unlike liquids these can be easily carried in bags, pusses, wallets, etc. These films are taste masked and have very good palatability. Being a unit dose, dose uniformity can be ensured with thin films which is a problem in case of liquid medicines. Fast dissolving thin films are not only helpful for special need patient population but are also desirable by other groups of patients. Going by the presence of ZIM labs in the markets for almost three decades, how has the company performed so far? Although the company has been in existence since last several years it has kept changing with the times and requirements of the market continuously. Starting from humble beginnings in 1990 as a tiny organization of 15people catering to the local institutional business, Zim is today a mid-sized formulation manufacturer with multiple facilities, highest accreditations, an export presence in about 50geographies and multiple business streams. The latest avatar of the organization which saw accelerated growth and achievement of niche product leadership is not more than 6-7years.
What are the advantages of thin film drugs as compared to traditional dosage forms?
What do you see the company’s competitive edge?
The conventional oral solid dosage forms, like tablets and capsules and other oral forms have been used largely for adult population. However, not everybody can swallow medicines or carry or ingest them in a non-messy manner. Special patient populations like pediatric, geriatric,
Zim is a process innovation company which develops various technology platforms for delivery of pharmaceutical products, resulting in product differentiation and enabling patient convenience and treatment adherence while maintaining affordability. For e.g. for several years we
10 â—„ March 2018
have been manufacturing and supplying pellets, granules, tablets, capsules etc. in sustained release, controlled release, taste masked etc. using different compositions. This enables the company to have strong capabilities in the development and manufacturing of complex generics and differentiated products. We at Zim see this as our main competitive edge in any crowded price sensitive pharmaceutical market whether domestic or international. How does the company keep abreast with the ever-changing trends in the pharmaceutical industry? Our passion for innovation keeps us constantly engaged with our various bus ines s partners in de v e lo p in g n e w products which are differentiated in delivery or composition. This is critical to keep abreast of new and changing technology and market requirements. In addition we also keep ourselves aware of the latest developments in pharmaceutical science and product approvals as reported in scientific journals and trade magazines, attending and networking at various workshops and conferences on different subjects of interest for our organization to gain an understanding of the latest trends and areas of work by peer companies and scientists, displaying the company’s work in various trade fairs and interacting with existing and potential customers and receiving their inputs and knowledge, and finally carrying out collaborative research work with key academic resource persons to build our capabilities in cutting edge areas relevant to us. L a s t y e a r, Z i m L a b o r a t o r i e s partnered with Nagpur University in developing a new drug for treating multi-drug resistant (MDR) uropathogenic bacterial infections under Rashtriya Ucchatar Shiksha Pharma Bio World
TM
Quality. Speed. Simplicity. To lead in today’s fast-paced generic drug environment, manufacturers must:
Meet increasing quality standards. Ensure fast, efficient response to market needs. Move product to market quickly. The West AccelTRATM Components Program is designed to deliver quality, speed and simplicity to meet the unique needs of the generic drug industry.
Suitable for Steam & Gamma Sterilization
USP & EP Compendial Compliance*
Quality
Extractables Report for Drug Compatibility Assessment
Westar® RS & RU Certified 13 & 20 mm Serum and Lyo Stoppers
Optimized Lead Times for Samples & Commercial Quantities**
pli
4031/45
city
TM
ed Spe
Proactive Technical & Regulatory Support
Ability to Withstand Multiple Punctures
m Si
Particle Specification Results Provided Per Lot
Global Availability
*JP compliance pending. **Commercial quantities available for customers in 6 weeks with provision of 90-day notification and forecast.
Rely on West’s more than 90-year industry-leading technological components. expertise and quality – Choose TM
For more information, contact us today via your West Account Manager or at www.westacceltra.com, or call us at the numbers below, to see if you’re eligible for free AccelTRA™ elastomer samples.
North America +1 800-345-9800 | South America +55 11 4055-6091 | Europe +49 2403 7960 | Asia Pacific +65 6862 3400 West and the diamond logo, Westar and AccelTRA are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. For complete contact information please visit www.westpharma.com. Copyright © 2018 West Pharmaceutical Services, Inc.
interview A b h i y a n ( R U S A ) ’s R e s e a r c h and Innovation (R&I) Project ‘ Te c h n o l o g y Tr a n s f e r. I n t h i s backdrop, Could we have your views on government initiatives in linking between academia, industry and government to achieve economic growth and build innovation ecosystem in India? We have been regularly participating in such government initiatives and believe that such collaborative work can add immense value to both academic institution as well as industry by reducing the cost of innovation, making research work at Academia more relevant to society and bridging the gap between provided and required knowledge for students who will ultimately become part of the industrial e c o - s y s t e m . We h a v e a t r a c k r e c o r d of being one of the more successful organizations in such collaborative work. Although the government is making a great effort in creating more linking opportunities between academia and industry, much more needs to be done in terms of tuning the interface between both to start contributing to economic growth and building innovation eco-system in India. • There is a need for the industry to have a deeper and earlier intervention in affairs of Academia to develop confidence that projects sponsored by them will be treated with required seriousness. • F u r t h e r, A c a d e m i a n e e d s t o m a k e fundamental changes in its working and policies to incentivize the researchers including faculty to undertake meaningful work which will create value in the market place. • Also, industry needs to be a motivated partner for working with academia by the government proposing various tax and other incentives to compensate 12 ◄ March 2018
for the time and resources deployed by the industry. • Finally, as innovation cannot exist in i s olation efforts are needed for various inter-disciplinary universities and colleges to be geographically placed in proximity of each other as well as various industrial research facilities as is found elsewhere. What is your view on the g o v e r n m e n t ’s ‘ M a k e i n I n d i a ’ initiative? As a top player in OTF manufacturing, how you think this initiative catapulted India into top manufacturing economies? What, according to you, are key hurdles in the path of ‘Make in India’ initiatives? The government’s Make in India initiative is a strong step in the right direction, as it will help in building India into a modern industrial power capable of absorbing our youth into the right jobs and career which will suit their ability and ambitions. This has the potential to certainly catapult India into becoming a top manufacturing economy. The key hurdles are: • Education and training system which makes youth directly employable • Changing of culture with reference to professionalism in corporate management and attitude towards work discipline, following processes and systems which lead to international quality products.
Kindly outline the future roadmap for your company? What are the new business domains you are foraying into? Zim sees itself as a process innovation company creating several technology platforms going forward aimed at addressing patient convenience and adherence. The future trends favoring highly potent generic medicines and large molecule & biological formulations require new and novel modes of administration. The trend towards multi-busters and customized medicines is very interesting opportunities for any pharmaceutical formulation process innovator and we intend to develop further capabilities to meet these requirements through co-development partnerships. . In the near future, Zim has plans of leveraging its current capabilities, in development, manufacturing and supply of various generic products under different dosage forms to increase its geographical foot print in the emerging markets both as semi-finished and finished formulations. It also has plans to enter the regulated markets in next three years – particularly with the Oral Thin Film technology in partnership with leading marketing companies. We also intend to leverage our formulation development capabilities to enter the codevelopment and out-licensing business as well as the Nutraceutical market.
• P o l i c i e s w h i c h f a v o r a n d r e w a r d investment in innovation and in ease of doing business. • Funding avenues for first generation entrepreneurs and a social and regulatory framework which “allows to fail”. Although the government has taken several positive steps, more steps are definitely welcome going forward to address above. Pharma Bio World
Indian Pharma Packaging Industry: The Need to Unlock Untapped Potential The global pharma packaging industry is thriving with modernization due to several drivers - regulatory changes, evolving product composition with biologics rapidly expanding, and other end-user trends such as patient adherence, child locking, and dose monitoring driving. Consolidation in the Indian pharma packaging industry is imminent in this evolving landscape. With no upstream innovation backbone, Indian companies will choose between status quo implying stagnant presence in an industry rapidly adapting to change or to seek growth capital, adopt technologies and seek growth propelled by partnerships for technology and market access. This will create continued momentum for in-bound strategic investments as well as trigger a surge in joint ventures and PE investments in the segment.
Aparna Balasubramanian Senior Consultant Sathguru Management Consultants
Hansini Mutte Senior Consultant Sathguru Management Consultants 16 ◄ March 2018
P
ackaging plays a crucial role in the pharma industry, where its function extends beyond serving as a branding aid and providing barrier protection to products for the shelf life period. It is increasingly playing a vital role in ensuring overall patient safety by carrying key information pertaining to the product, ensuring tamper-evidence and traceability of products. The global pharma packaging industry is thriving with modernization due to several drivers.
in the context of packaging. With most biologic drugs being injectables, glass is the logical choice for primary packaging. However, some biologic drugs are found to interact with glass, delaminate it, causing flaking. Silicon oil, a commonly used lubricant in plunger of pre-filled syringes as well as in rubber stoppers in glass vials, is susceptible to drug interactions and capable of denaturing/ aggregating protein drugs and in some cases, even making the drug immunogenic.
Regulatory Changes Driving Packaging Innovation Globally
Research is being pursued on low-silicon or silicon-free alternate packaging to circumvent this challenge. Industry is also considering cyclic olefin copolymers based packaging as replacements for glass in biologic drugs. Excellent moisture barrier properties combined with their intrinsically inert and non-reactive nature makes them excellent choices for biologic drugs. Outstanding material clarity also makes it visually comparable, yet a sturdier alternative to glass. In essence, with continual innovation in drugs and delivery technologies, there is simultaneous need for synergistic evolution from the packaging industry. With cell therapy and gene therapy gaining momentum globally, there are more packaging questions looming in the horizon that need addressing.
Serialization is a global buzz word that is transforming packaging industry as whole, more so in pharma where counterfeit products have perilous consequences. There is growing regulatory thrust in this direction with complete unit level track and trace becoming an everyday reality. The US’ Drug Quality and Security Act (DQSA) and the EU Falsified Medicines Directive (FMD) are newer developments that stipulate issue of unique serialization codes to the smallest saleable units of pharma products. Although being implemented in a phased manner, there is high frenzy around compliance preparedness in the industry given the strategic importance of these target markets for the global pharma industry. Multinationals such as Pharma Packaging Solutions (PPS) are already offering comprehensive track and trace solutions for packaging today. Evolving Product Composition Rethinking Primary Packaging
–
Expanding share of large molecule drugs within the pharma pie has raised questions on extractables and leachables
Patient-centric Packaging Innovation Changing patient lifestyles and growing middle class affordability across the world is changing drug delivery landscape and bringing new unmet needs that provide pharma packaging companies impetus to innovate: • Patient Adherence/ Compliance: With ageing population and increasing life expectancy, share of geriatric patients Pharma Bio World
ADVERTISE TO EXPAND
your reach through
A DVERTISE TO EXPAND your reach through
VOL.14 | ISSUE 6 |
CHRONICLING PROCESS INDUSTRY INNOVATIONS SINCE 1966
The Journal of Materials & Equipment for the Process Industries
VOL. 36 NO.4
VOL 16 | ISSUE 05 | DECEMBER 2017 | MUMBAI | TOTAL PAGES 60 | PRICE ` 150
A N N I V R SARY E
www.cpfindia.com Vol. 36 No. 4 October-November 2017 Mumbai ` 100/-
INSIGHT INTO UPSTREAM & DOWNSTREAM HYDROCARBON INDUSTRY
CHEMICAL ENGINEERING WORLD
INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
HSE in Oil & Gas Industry
www.pharmabioworld.com DECEMBER 2017
CHEMICAL PRODUCTS FINDER
PHARMA BIO WORLD
VOL.52 ISSUE 12 Mumbai
DECEMBER 2017
OCTOBER-NOVEMBER 2017
VOL 16 ISSUE 05
MUMBAI ` 100
` 150
MUMBAI TOTAL PAGES 64
ChemTECH South World Expo 2017 Special
International Exhibition & Conference 21-23, February 2018 : Mumbai, India
GUJARAT - 2018
MUMBAI - 2019
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India ` 150 GUJARAT - 2018
MUMBAI - 2019
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India
JASUBHAI MEDIA PVT. LTD. Taj Bldg., 3 rd Floor, 210, Dr. D. N. Road, Fort, Mumbai-400 001 Tel.: 91-22-40373636, Fax: 91-22-40373635 E-mail: industrialmags@jasubhai.com
HYDERABAD - 2017
GUJARAT - 2018
13-15, December 2017 Venue: Hyderabad, India
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India
MUMBAI - 2019
OCTOBER-NOVEMBER 2017 | MUMBAI | US $ 10 | ` 150
VOL.52 | ISSUE 12 | DECEMBER 2017 | TOTAL PAGES 92 | US $ 10 | ` 150
www.oswindia.com
within the pharma target population is growing and provides room for targeted innovation. While digital medicine with in-built sensors is making inroads in compliance monitoring and connected care, Abilify MyCite from Otsuka and Proteus Digital Health, for schizophrenia, being the first digital pill approved by FDA last year, packaging innovations also contribute their share in enhancing patient adherence. While features such as daily dose markings on the pack are fairly common, advanced features such as digital timers and alarms on pill bottles reminding patients of the time for next dose are already on the market in the western world. • Accurate Dosing and Dose Monitoring: Dose monitoring features in packaging are increasingly playing a role in abuse deterrence as well as patient adherence. Novel technologies range from simple metered dosing systems to calendar-enabled closure technologies that tracks, counts pills as they get dispensed and send the data to a smart phone. Unit-dose packaging with key drug details incorporated in every dose are increasingly finding preferred applications in hospitals and clinics as a convenient and safe option, driving allied trends in packaging. • Tamper protection and Child Lock: With high contribution of pharmaceuticals in non-fatal childhood poisoning, need for child locking mechanisms in pharmaceuticals is critical. Although such solutions are commonplace, packaging companies continue to incrementally innovate in striking the right balance between making it inaccessible to children but not too difficult for geriatric patients. Several innovative packaging mechanisms are evolving in blister packs for tablets as well as bottles and inhalers. 18 ◄ March 2018
• Sustainability and Carbon Footprint: Although not a principal concern in pharma industry, growing importance in other packaging industries such as FMCG has trickled into due to convergence in packaging suppliers. Factors such as lean manufacturing and energy-conserving packaging lines are being given increasing importance in the pharma sector. There are also product innovations in primary packaging such as Formpack Ultra from Australian packaging firm Amcor. A technology innovation in blister packs segment for oral solids, it allows cavities to be drawn deeper, thereby minimizing overall size of the blister pack and volume of secondary and tertiary packaging, eventually translating a cascading effect on waste minimization across the value chain. There is also growing focus on minimizing PVC content in pharma packaging due to unfavorable environmental footprint. Indian Pharma Packaging Industry – Current Landscape & Potential Impact of Global Trends Today, India is undoubtedly the pharmacy of the world, exerting indomitable strength in manufacturing of generic drugs for US and other global markets. Increasing regulatory scrutiny in global markets thus has a direct bearing on sustaining competitiveness of Indian industry. While Indian pharma companies are escalating themselves in the value chain, transitioning into higher value areas such as specialty pharma and NCEs, the allied industries of pharma packaging have been slower to evolve. Indian pharma packaging industry is structured in the form of a pyramid with an extended base. At the top, there are multinationals such as West Pharma, Huhtamaki, Amcor, and SGD Pharma with marketing offices or manufacturing units
in India as well as large Indian companies such as UFlex and Essel Propack. At the base, the industry is deeply fragmented with multiple smaller companies dotting the landscape, with most being generalized suppliers catering to multiple sectors such as food, pharma, and personal care, with generic product offerings. These smaller companies tend to focus exclusively on specific parts of the value chain, whether it is in segments of primary packaging like blister packaging, HDPE bottles, ampoules etc. or in segments of secondary packaging including labels, pouches and cartons. The industry is therefore largely commoditized with no significant differentiation being offered by smaller companies. As Indian pharma companies continue to expand further into regulated markets, it is imperative that the allied industries of packaging move beyond the value proposition of cost advantage, especially the rapidly evolving regulatory landscape. Indian packaging companies need to rise to the challenge and get futureready to support the pharma players in their quest for growth. However, while there is high level of cognizance in the industry of the evolving regulatory and innovation landscape, it has not resulted in significant change in Indian industry’s engagement in technology development or adoption. Some established players such as Bilcare are embracing global technology advancements, but considering the fragmented nature of the market, the momentum needs to be accelerated. Future growth for packaging companies will be driven by the food and pharma sectors, and given regulatory implications in both these industries, companies which can offer clients reliability and a familiarity with regulatory requirements will be able to stand out in this crowded space. Therefore packaging companies should consider development of specialized Pharma Bio World
INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
PBW Spotlights » Indian Pharma and Biotech
Industry Globalisation » Latest Developments in Pharma
Innovation and Technologies » Future Trends of the Industry » Current Indian and International
Corporate News » Novice & Updated R & D
Strategies » In-Depth Market Research » New Product Launches » Event Alerts and Many More……
JASUBHAI MEDIA PVT. LTD.
Taj Bldg., 3rd Floor, 210, Dr. D. N. Road, Fort, Mumbai-400 001. Tel.: 91-22-40373636 | Fax: 91-22-40373635 E: industrialmags@jasubhai.com W: www.pharmabioworld.com
www.chemtech-online.com
27-29 April 2018
Parade Ground, Sector 17 Opp. ISBT, Chandigarh (UT), INDIA
Visit Us at Stand Stall No. B-56
M&A Transactions Year
Target
Acquirer
Deal Value ($M)
Deal Type
2017
Sunrise Containers
Thai Plaspac
- Inbound
2017
3D Technopack
Hoffmann Neopac AG
- Inbound
2017
Super Label Manufacturing LLP
Pacman M.E LLC
3.75 Inbound
2017
Four M Propack
Shriji Polymers India.
2.82 Domestic
2016
Essel Deutschland
Essel Propack Ltd.
24 Outbound
2015
Packaging India
Amcor Flexibles India
26 Domestic
2014
Positive Packaging
Huhtamaki PPL Ltd.
2014/2012
Skanem Interlabels
Skanem AS
• Indian companies partnering with global majors for technology access in dilutive and non-dilutive partnership models • Indian companies forging access centric partnership
137 Inbound
Year
Target
Investor
2016
AVI Global Plast
Multiple investors
2015
Shriji Polymers
Tata Capital
2015
Manjushree Technopack
Kedaara
23
2014
Radha Madhav Corporation
Multiple investors
2.4
Budding M&A Landscape and Need to Catapult Innovation Appetite Given the low levels of technology innovation and relatively small size of companies in the fragmented industry, Private Equity transactions have been few and far between. However, there has been increased M&A activity in the recent past, especially in 2017, 20 ◄ March 2018
market
• Surge in growth capital investments for infrastructure improvement, capacity addition, technology innovation
39 Inbound
Private Equity Transactions
focus in these sectors. Between the two segments, pharma offers wider possibility of margin accretion compared to food where higher realization could be limited to segments such as organic or ready-toeat foods.
investments in the segment. Case in point is an investment transaction lead by Sathguru’s investment banking team – Oaktree Capital and SGD Glass investing in Cogent Glass, an Indian company that now benefits from SGD’s upstream innovation backbone and specialty technology strengths. We foresee four major M&A trends in near future:
Deal Value ($M) 0.07 -
• Global companies acquiring Indian firms for their manufacturing capabilities, technology innovation or market access With imminent consolidation – pharma packaging providers from India are poised for significant growth - realization of which will depend on adapting, aggressively and rapidly to the evolving landscape.
with interest from global companies. Some of the notable transactions are given below. Consolidation in the Indian industry is imminent in this evolving landscape. With no upstream innovation backbone, Indian companies will choose between status quo implying stagnant presence in an industry rapidly adapting to change or will need to seek growth capital, adapt technologies and pursue growth propelled by partnerships for technology and market access. This will create continued momentum for inbound strategic investments as well as trigger a surge in joint ventures and PE
Contact: healthcare@sathguru.com Pharma Bio World
Pharma Bio World
SPECIAL SUBSCRIPTION OFFER India’s premier magazine providing insights into the Pharmaceutical & Biotech Industry, which is now into its 14 th year of publication is presenting a special offer for its readers & subscriber. Now Get to read important topics in the forthcoming issues.
Subscription Period
Subscription Amount
Amount To Be Paid
1 year
` 1800/-
` 1530/-
2 year
` 5400/-
` 4050/-
3 year
` 9000/-
` 5400/-
Please fill up the contact details First Name ..................................................................................................................................... Last Name ..................................................................................................................................... Firm Name ..................................................................................................................................... Email .............................................................................................................................................. Mailing Address ............................................................................................................................. ........................................................................................................................................................ City ................................................................................................................................................ Pin Code ........................................................................................................................................ State .............................................................................................................................................. Contact Number ............................................................................................................................
PAYMENT OPTIONS Cheque : Please send your cheque in favour of “JASUBHAI MEDIA PVT LTD”. payable at Mumbai. Add ` 50/- for outstation cheques. BANK TRANSFER Beneficiary: JASUBHAI MEDIA PVT.LTD Bank: HDFC Bank Ltd Branch: Marine Drive Address: 143, Ground Floor, Soona Mahal, Marine Drive, Mumbai-400021 Bank Account No.: 12122020002057 IFSC Code (NEFT/RTGS): HDFC0001207 Swift Code (Iternational Remittance): HDFCINBB
All the above complete field along with cheque should reach us at: Jasubhai Media, IA&B Division, 3rd Floor, Taj Building, 210 Dr D N Road, Fort, Mumbai-400001. Tel: 022-4037 3636
Packaging and Labelling of Pharmaceuticals and Nutraceuticals You might not pay attention to the packaging of a product, but the absence of it, or the bad quality of it will definitely be noticed. Packaging of any product is a multifaceted process that helps in safeguarding the product from the moment it is packed, ensures branding and recognition. In the medical and Pharma world specifically, there are more nuances to keep in mind while designing and manufacturing packaging materials.
P
harmaceuticals and nutraceuticals require critical packaging. There are key metrics to be kept in mind and followed for these products to ensure adherence to quality control metrics, safety, ease of handling, ensuring longevity - before and after opening the seal. Let’s consider the case of certain nutraceuticals that contain bioactive compounds. The packaging needs to sure that the product is microbiologically safe with easy accessibility throughout the processing and storage phase. In the case of nutraceutical beverages, it becomes more critical to ensure proper sealing even after the product is opened. Recent research has enabled the implementation of dispenser-cap made of polycarbonate and tritan for beverages. In these type of caps, the dry premix for the beverage is filled in the cap and sealed. This is particularly advantageous because the ready beverage containing nutrients and bioactive components may be prone to microbial spoilage and deterioration with time. When dispensing caps are employed, the ingredients are dispensed into the liquid while opening the bottle and the drink is made freshly just before consumption. This can also be a great way to preserve the bioactivity of a photosensitive ingredient since it won’t be exposed to sunlight at all. In recent times, packaging has also evolved to consider single serves more, since this reduces the risk of contamination and in case of pharmaceuticals, the dosage can be easily monitored.
Rohini S Food Scientist NutriParadise Foods 22 ◄ March 2018
Pharmaceuticals have to keep mind the potential pollutants and QC Checks. In nutraceuticals, the company has to keep in mind the potential consumer brand
image, eco-friendliness of the packaging, sustainability and more. The consumer, who would not particularly delve on these aspects in a tablet, would consider this quite strongly in nutraceuticals. New Forms of Packaging Plastic, which was the go-to favourite for packaging various food and drink items has slowly evolved to include various ecofriendly options. It is vastly prevalent in the market, and the consumer behaviour typically leans towards reusing these plastic objects instead of safe disposal. Several companies are replacing plastic with ‘edible packaging’, which is more ecofriendly as well. Smoothies and other drinks can be primarily packaged in such material, which has low oxygen and moisture permeability. Then these edible pouches are laid down in a secondary pouch made of metalized polyethylene terephthalate, which protects the edible packaging from external factors and keeps the product intact. This method ensures reduction of packaging material that must be disposed Edible packages are also impregnated with antimicrobials to enhance the safety, with flavors, bioactive compounds for sustained release, antioxidants to preserve the product can also be used to increase the quality and shelf life of the pharmaceutical and nutraceutical products. Pharma and nutraceuticals are also increasingly using ‘smart package systems’. Intelligent sensors used in the packaging systems indicate the status of the product inside by various mechanisms. The indicators detect the volatile compounds produced by the products, especially in beverages and syrups, to assess the quality and freshness. The Pharma Bio World
اﻟﻤــﻌــﺮض اﻟﺴــﻌــﻮدي اﻟــــﺪوﻟـــﻲ ﻟﻠــﺼﻴـــﺪﻟـــﺔ
www.saudipharmaexpo.com
Register Now 10 - 12 Rabea Alawal 1440 AH 19 - 21 November 2018 Riyadh International Conference & Exhibition Center Riyadh - Saudi Arabia Center
An EXCELLENT opportunity to invest and expand your business in Saudi Arabia and international pharma industry
www.saudipharmaexpo.com
Saudi International Pharma Expo 2018 SIPE 2018 will give you the opportunity to explore the latest industry trends from all over the globe, and the Kingdom of Saudi Arabia , where the pharmaceuticals market is projected to expand by a compound annual growth rate of 10% up to 2020 to reach ($13.6bn). We target more than 250 exhibitors from all pharmaceutical sectors in more than 140 countries around the world Organized by
CM2017-44
T: +966 9 200 200 25 / F : +966 11 204 4454 P.O.Box : 295771 Riyadh 11351 Saudi Arabia Email : Info@saudipharmaexpo.com / Website : www.saudipharmaexpo.com
packaging is designed to change colours, or embedded with a sensor strip to indicate changes in the status of the product. This is especially useful in pharmaceutical packaging and can prevent the fatal mistake of consumption of expired drugs leading to serious consequences. Some products have begun to include temperature sensors, which change color based on the storage temperature and helps in monitoring the shelf-life of the product. The idea of incorporation of gas concentration indicators in gas flushed functional products has been conceptualized in the company in the interest of consumer safety. These indicators detect the concentration of gases such as oxygen and nitrogen flushed inside the packaging for better shelf life. This may help consumers to choose the best product to pick up from the shelves. Biosensors such as polydiacetylenes are to be used in some products in the coming years to make it easier for consumers to find out microbial contamination and spoilage of the products. Microbiological safety and least cross contamination even during consumption of the product are of utmost importance when it comes to convenient therapeutic products. Self-heating pouches come in handy when ready-to-cook therapeutic products are to be cooked without taking them out. The concept is essentially based on a simple exothermic reaction. A layer of salt is placed between two layers of metalized polyethylene terephthalate. Water can be added through a nozzle, strategically placed on the top. When the water is poured on the salt, exothermic reaction takes place which heats up the pouch cooking the product inside. This will minimize the cross contamination that might happen while transferring products to utensils and during cooking. It is also quite convenient for the patients admitted in hospitals as well as at home to not bother with cooking and straining themselves for the sake of having nutritious food. 24 â—„ March 2018
Automation and application of robotics to conserve microbial safety are swaying especially the convenient-therapeutic food and pharmaceutical industries as they attest for quality, safety and efficiency. Complete automation of manufacturing and packaging processes can minimize errors and enhance accuracy. Reduction of headcount in the manufacturing area can greatly reduce the risks of contamination and hazards. This can be accomplished by employing robots instead of human resource in manufacturing units which can be sterilized regularly to practice good manufacturing practices. Labeling Despite all the care taken during packaging, labelling becomes an essential part of completing the process. Packaging and labeling have a major hand in appealing to the consumer by showing off the sophistication, assuring safety and promising wholesomeness. A proper labeling can have a magnetic effect on the buyer with the information provided. Increasing health consciousness and awareness in the field of pharma and nutraceuticals are demanding for thorough and detailed labeling. This creates a sense of trust in the consumer and promotes brand loyalty. An attractive and relevant packaging can drive the consumer to buy the product but only the efficiency of the packaging material can force him to stay with brand. Packaging and labeling are the most powerful salesmen one can have. They speak of the products and market them without voice but they can be louder than any representative when they are designed the best. World is transforming into a highly developed place calling for advancement in every field. Packaging technology is growing at lightning speed alongside futuristic product development. Innovation and creativity have made way for inventions that once were thought impossible. Aim to make everything convenient, nature friendly and long lasting has opened doors to development
of technologies which make life easier. Development in the field of packaging technology is never ending as long as there is product development. It is also equally true that advances in packaging technology have made it possible to design products in a better and innovative way. It has also aided in delivering the best quality products in every field. Pharma labelling is more critical, with manufacturers having to comply with the latest QC checks and regulations. The industry is a mix of functional performance requirements, compliance, meeting multicultural demands and brand positioning. And then the most critical function - establishing the validity of the product and avoiding counterfeits. Labelling in the nutraceutical industry is still growing. Nutraceuticals are catching on in the B2C segment as people grow more consciousness about their lifestyles and health. Newer classifications are required almost every few months, adding more product categories, changing guidelines and more. Labelling in this industry is a lot more strict since these are not needbased products and indulge in marketing to entice the potential customer. The product has to be packaged attractively, and labeled such as to attract the customer and make them believe there is a need for the product without misleading them. Guidelines regarding nutraceutical labels are yet evolving in India. There are more regulations for labelling nutraceuticals than even 5 years ago, but there is a long way to go. Food safety certifications apart, there needs to be an entity to pass the labelling for nutraceuticals as well. The Food & Safety Authority of India has issued various guidelines for nutraceuticals. But as we evolve and process more products in this category, and the competition in this field heats up, changes are inevitable.
Contact: juthika@pepperinteractive.in Pharma Bio World
MEDLAB
expo THE SAUDI INTERNATIONAL MEDLAB EXPO
19 - 21 November
2018 Riyadh International Convention & Exhibition Center.
Register Now THE SAUDI INTERNATIONAL MEDLAB EXPO We are targeting more than 250 exhibitors from 140 countries.Their participation, spanning multiple industry sectors and including companies, distributors, manufacturers relevant to the below field of interest:
• Laundry • Home health care • Surgical centers • Hospital equipment • Meals and catering • Medical technology • Laboratory equipment
• Hospitality and furniture • Medical consumables • Infirmaries and monitoring • Uniforms, linens and towels • Traumatology and postoperative recuperation • Projects, installations and constructions
• Forensic Science • Agriculture & Food • Clinical Diagnostics • Environmental Science • Specialized medical literature • Biotechnology & Life Science • Biotechnology & Life Science CM2018-4
Organized by
T: +966 9 200 200 25 / F : +966 11 204 4454 P.O.Box : 295771 Riyadh 11351 Saudi Arabia Email : Info@.saudimedlabexpo.com Website : www.saudimedlabexpo.com
case study
Cutting-edge Technology can Bridge the Gap between Strategic Vision and Operational Reality in Pharma Logistics
H
ealthcare is a critical segment in India, with the nation expected to rank amongst the top three healthcare markets in terms of incremental growth by 2020. The sector, one of the fastest growing in the country, is expected to see a CAGR of over 22 per cent to reach USD 280 billion by 2020. Not surprisingly, major business groups in India have also forayed into the healthcare sector, setting up hospitals that have huge logistics requirements. To cater to this logistics requirement, a specialized player like Avvashya CCI Logistics (ACCI) has an important role t o p l a y. A C C I h a s d e v e l o p e d s t r o n g capabilities in specialised healthcare solutions that bring down both costs and operational hassles for hospitals, thus freeing them to focus on patient care. ACCI is a subsidiary of Allcargo Logistics Ltd, India’s largest integrated logistics solutions provider in the private sector. Through its expertise, professional management and DNA of reliability, the company uses state of the art technology and infrastructure to manage the nuances for a smooth supply chain in hospital logistics. An emerging opportunity: Need for Hospital aqnd Healthcare Supply Chains to be More Efficient: Supply chain logistics requirements for pharma and hospital industry are unique — time bound delivery and temperaturecontrolled environments are critical. With its years of sectoral expertise, Avvashya CCI Logistics (ACCI) delivers world-class solutions for healthcare logistics and inventory management. Pharma companies and hospitals are looking at the next phase of growth, but there is a significant gap between strategic vision and operational reality.
26 ◄ March 2018
Among other factors, one of the critical enablers of growth for India’s pharma and hospital industry is maturity and quality assurance in terms of supply chain logistics. There is a pressing need for hospital and healthcare supply chains to be more efficient: to cost less and provide better service. There is another unique aspect to hospital logistics — the fact that internal hospital logistics is even more complex than the external side, and medical staff spend disproportionate amounts of paid time performing logistics activities — time which would be better used to provide patient care. Consider this: any large hospital uses a vast amount of material in the care and treatment of its patients — a 1,500 bed hospital will have to manage a fast-moving inventory of as many as 3,000 stock-taking units (SKU) every day. What does that mean from a logistics perspective? For the hospital, logistics makes for as high as one-fourth of operating costs. When it comes to inventory and stock management, hospitals have specialised needs that are vastly different from any other industry. For example, there is a vast amount of glassware and fragile items, along with large beds and electronic equipment, as well as medicines which have to be used up as per expiry dates! For hospitals, the supply chain strategy should be to maximise patient care by: • Ensuring product availability. • Minimising storage space and inventory, thus maximising space for patient care. • Reducing material handling time and costs for all medical staff (nurses, pharmacists, doctors, etc.)
Access to efficient and cost-effective logistics services is a big factor enabling hospitals to reduce incurred costs on procurement and transportation, thus paving the way to affordable healthcare. This new-found focus on supply chain improvement has given rise to an increasing trend toward centralisation and customercentric thinking. This is where Avvashya CCI Logistics Pvt Ltd (ACCI) steps in. ACCI has developed strong capabilities in specialised healthcare solutions that bring down both costs and operational hassles for hospitals, thus freeing them to focus on patient care. Healthcare-specific Solutions Partnering some of the India’s top chemicals companies, ACCI has established its reputation in the market for expertise in handling chemicals and hazardous materials, as well as superior competencies in agro chemicals, pharma products and packaged food. When it comes to healthcare, ACCI has developed customised solutions that handle the complete supply chain logistics — from vendor to warehouse, warehouse to hospital bin, bin management to billing support — while also taking care of minute aspects such as expiry dates on medicines. A case in point: Painless inventory – Delivering high value service to a leading hospital chain: Avvashya CCI Logistics Pvt Ltd (ACCI) has been delivering high value service to leading hospital chains in metro cities for over three years. The company manages end-to-end operations at six critical locations of its key client and handles 3,000 fast-moving stock keeping units (SKUs) at its warehouses. Pharma Bio World
case study The clients faced a few crucial challenges including: • Setting up a centralised warehouse for fast moving SKUs. • Consolidating stocks from suppliers and replenishing all its hospitals. • Focussed replenishment to a 1,500-bed hospital with store support. • Inventory management and planning. • S t o r a g e c a p a c i t y a n d r e s o u r c e management.
chain network that is aligned with the organisation.
costs. For this client, ACCI handles a flow of upto 120,000 items per day. ACCI’s aim is to partner hospitals by: • Developing, strategic supply chain management (SCM) that will enable hospitals to meet higher standards of patient outcomes by timely replenishment. • Reducing and redefining the distribution models. • Introducing best practices to build a lean material flow, integrate SCM processes and achieve higher e ff i c i e n c i e s t h r o u g h o u t t h e s u p p l y chain.
Designs, Inventory, Performance ACCI’s expertise in efficient movement of materials can help hospitals reduce excess inventory, which in turn, can have a direct positive impact on bottom lines. ACCI is involved right from hub management, facility layouts, and warehousing processes. Moreover, it also handles critical aspects such as individual requirements for material storage and preservation, such as humidity and temperature control.
ACCI took on the challenge and delivered Inbound and outbound operations at the value in three main areas. It ensured consolidation of material arriving from • Continuous improvements across the hub level and at the hospital premises are all managed through smooth and efficient multiple suppliers, which led to reliability supply chain by receiving feedback processes, including labelling that ensures in supply and consequently no stock-outs. from the end-user departments. seamless processing of material right up to The company worked with the hospital to prepare bin locations, resulting in improved • Eliminating inefficiencies by setting billing against individual patient records. right processes at hub and for delivery performance in picking. It also integrated ACCI also works with the hospital to operations. customer requirements, ensuring efficient management andbetter visibility, reporting dashboards are created andperformance shared atmanagement, all improve by coordination and reduction in logistics • E s t a b l i s h i n g a n i n t e g r a t e d s u p p l y p r o v i d i n g k e y p e r f o r m a n c e i n d i c a t o r
levels. Following is the process chain:
Receipt
•Every product recieved at the warehouse is screened for visual contamination and packing condition •For every unit, batch details are captured at GRN transaction •PO vs GRN data is validated
Storage
•Storage logic: Categorical binning •Mapping of the products with the batch details: Tracking expiry management •Periodic audit helps in near expiry: Which is moved to a near expiry zone: Future Picking
•Distribution from hub is done in dedicated vehicles to curtail any possible mis-management Transportat •All the documents carry the batch information of the products ion
Delivery
•Inventory is delivered to the specific teams at multiple sites •GRN is again done at receiving location reflecting batch details •Batch details are captured for every order that is delivered
Figure 1:
The Indian healthcare industry is in an evolutionary phase. Advanced methodologies like Pharma Bio World industry Machine learning to examine trial data, Artificial Intelligence (AI) technologies can enhance and assist with patient enrolment forecasts which are options that can bring higher efficiency.
28 ◄ March 2018
Asia’s Dedicated Exhibition & Conference Platform for Biopharmaceutical R&D
20-22 June 2018, SNIEC, Shanghai, China Co-located with:
110+ Exhibitors . Protein . Polypeptide . Antibodies . Cell Biology . Genomic / Genetic
. Antigen . Enzyme . Biologics . Clinical Trials . Vaccines
ICSE China 2018
90+ Exhibitors
. Contract Research . Custom Synthesis . Clinical Research . Medicinal Chemistry
. Contract Manufacturing . Process Scale-up/ Optimization . API Synthesis . Intermediate Synthesis
CPhI China 2018
REG IST E
BioPh China 2018
R
W! NO
o de t R co ss! Q e th pa Scan our free y t ge
Dedicated networking with 15,000+ pharma R&D professionals from all over the world in 80+concurrent events: . 5th China BioPh Outlook Summit
1,800+ Exhibitors
. APIs . Dosage . Fine Chemical & Intermediates . Natural Extracts . Excipients & Formulation . Animal Health & Feed
www.cphi.com/china
. 2018 Drug Safety and Quality Management Forum . RNDer China Drug Development Summit: CDMO Forum . BioPh Salon (Insulin, Antibody Drugs)
Ms. Cindy Tan cindy.tan@ubmsinoexpo.com / +86 21 3339 2252
case study your reach through
CHRONICLING PROCESS INDUSTRY INNOVATIONS SINCE 1966
VOL.52 | ISSUE 5 | MAY 2017 | TOTAL PAGES 76 | US $ 10 | ` 150
VOL.52 ISSUE 5 Mumbai ` 150 HYDERABAD - 2017
GUJARAT - 2018
13-15, December 2017 Venue: Hyderabad, India
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India
MUMBAI - 2019
VOL 15 | ISSUE 10 | MAY 2017 | MUMBAI | TOTAL PAGES 60 | PRICE ` 150
www.pharmabioworld.com
VOL 15 ISSUE 10 MAY 2017
Quality by Design
MUMBAI TOTAL PAGES 60 ` 150 HYDERABAD - 2017
GUJARAT - 2018
13-15, December 2017 Venue: Hyderabad, India
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India
MUMBAI - 2019
INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
The Journal of Materials & Equipment for the Process Industries
www.cpfindia.com Vol. 36 No. 1 April-May 2017 Mumbai ` 100/-
VOL. 36 NO.1
Pumps, Valves, Actuators, Pipes & Fittings CHEMICAL PRODUCTS FINDER
APRIL-MAY 2017 MUMBAI ` 100
Technology is an integral part of ACCI operations. Avvashya CCI Logistics (ACCI) uses state-of-the-art Radio Frequency Identification (RFID) technology to track a n d m o n i t o r m o v e m e n t o f i n v e n t o r y. The RFID tags enable automation and optimisation, which helps bring down costs and enhances efficiency. This is where ACCI with its cutting-edge technology implementation delivers the differentiator in hospital and pharma management.
ADVERTISE TO EXPAND
PHARMA BIO WORLD
Te c h n o l o g y a c t s a s a k e y e n a b l e r i n upgrading the operational functioning of an industry. Healthcare organisations must strive for value addition across the entire supply chain and the answer lies in the latest innovations in RFID technology, supply utilisation management and virtually centralised supply chain management.
The major players in the sector include: Aditya Birla Memorial hospital, Manipal Hospitals, Fortis, Narayana Health, Max Healthcare, Wockhardt Hospitals, Apollo Hospitals and Vedanta. Today, healthcare providers are under enormous pressure due to increasing competition, government regulations, rising costs, demand for higher quality of service. Latest technology, global standards of safety and compliance, supported by qualified and professional workforce that understand the minutiae of hospital and pharma management, ACCI has already moved ahead taking giant strides in providing very successful hospital management and pharma management services to prestigious customers throughout the country.
MAY 2017
Technology in Healthcare Logistics:
Critical Sector:
CHEMICAL ENGINEERING WORLD
(KPI) tracking, especially of critical reports, review of manpower deployed and ensuring adoption of continuous improvement processes. ACCI also strictly ensures compliance with the Environmental, Health and Safety (EHS) guidelines and environmental regulations.
HYDERABAD - 2017
GUJARAT - 2018
13-15, December 2017 Venue: Hyderabad, India
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India
MUMBAI - 2019
Addressing Track & Trace and Visibility Measure There are various criticalities involved in warehousing and distribution of pharma products involving higher visibility measures for the entire process from receipt to delivery. For the efficient management and visibility, reporting dashboards are created and shared at all levels. (See Figure 1, Previous Page) The Indian healthcare industry is in an evolutionary phase. Advanced methodologies like industry Machine learning to examine trial data, Artificial Intelligence (AI) technologies can enhance and assist with patient enrolment forecasts which are options that can bring higher efficiency. 30 ◄ March 2018
V. Raju Vice President - Contract logistics – Chemical, Pharma & Food Sector Avvashya CCI logistics Private Limited Contact: sarona.dsilva@allcargologistics.com
JASUBHAI MEDIA PVT. LTD. Taj Bldg., 3 rd Floor, 210 Dr. D. N. Road Fort, Mumbai-400 001 Tel.: 91-22-40373636 Fax: 91-22-40373635 E-mail: industrialmags@jasubhai.com
Pharma Bio World
Emerging Trends in Biosimilars The success of innovator biologicals with downsides of high costs and patents expiring have contributed to development of Biosimilars coupled with advantage of regulations, adaptability by physicians and patients. Biosimilars being complex molecules need to have sound scientific strategic approach to development, manufacturing and research. Few legal issues have not dampened Biosimilar companies to have strong pipelines, quality and focused timelines to provide affordable and effective drugs to patients in need.
Dr Sudheer Balaraju Head - Medical & Safety Navitas Life Sciences and Swetha R Khokale Head Project Management – APAC Navitas Life Sciences 32 ◄ March 2018
B
iosimilars - The generic version of biologicals is not only an emerging trend but has paved its way to succeed and sustain in the world of pharmaceuticals. Biosimilars take credit for revolutionizing the development of targeted, effective and affordable biologic treatments required across various therapeutic areas like Oncology, Immunology, Endocrinology, Ophthalmology etc. This need has attracted major investors as the prospects are driven by streamlined regulatory guidelines with high adoption rate amongst physicians and patients. At Navitas Lifesciences, as a global CRO, we have been working with various global and regional Bio-pharmaceuticals companies on their innovative biologics and biosimilar projects. Over the years, this experience has leveraged us to understand and appreciate the contribution of biosimilars right from the clinical development at Sponsor’s end to complexities in study conduct, receipt of regulatory approval and finally being able to witness the much-needed access and benefit to patients. Biosimilars, as we know are highly similar to their licensed reference product in terms of quality characteristics, biological activity, safety, and efficacy. Unlike small molecule (chemical) drugs that can be fully defined structurally, biologics exhibit high molecular complexity which are isolated from natural sources and sensitive to changes in manufacturing processes that contribute to certain challenges in its development and receipt of marketing approval. Innovator biologics have no doubt proven efficacy, safety and have contributed to
several unmet medical needs, however high costs and affordability of these drugs cannot be discounted. As the patents and exclusivity for many biologics are expiring, this has created the huge opportunity for the development and approval of biosimilars for many biopharmaceutical players including innovator generics and biotech companies. The Global Biosimilars market is expected grow at 23 % CAGR over 2017-2023, from USD 4.10 Billion in 2017 to USD 14.23 billion by 2023. Biosimilar regulatory guidelines are evolving globally, European Union (EU) is more matured has biosimilar guidelines since 2005 followed by Taiwan, Malaysia, Australia, Japan, Korea, Canada, Brazil, Mexico, India and including USA, first biosimilar was approved by US FDA in March 2015. It is essential to have proper scientific, strategic approach with adherence to “Quality by Design” for the successful development of biosimilars. The need for overcoming challenges continues to the late clinical steps including drug safety factors and labelling requirements. Manufacturing processes for biosimilars have an independent design and need not duplicate the originator’s production methods. Instead, the focus is on extended characterization efforts to show that the biosimilar is ‘highly similar’ to the reference drug. That contributes significantly in reducing clinical efforts and costs for the biopharma’s. Effective management of Good Manufacturing Practice (GMP) facility is critical and requires vigilance throughout. Analysis of biosimilars and biologics are one of the most important aspect towards the Pharma Bio World
biologics and biosimilar development process and hence again critical while designing the study protocol. Some of the emerging biosimilar products are recombinant blood products, therapeutic proteins, vaccines, growth hormones, biosimilar peptides, therapeutic proteins, monoclonal antibodies (mAbs) etc. Biosimilar insulins are the most expected ones in the class to enter the biosimilar landscape as patents for major branded insulin products start to expire in the next few years.
One aspect that cannot be ignored are legal issues pertaining to biosimilars which is the need of the hour to be addressed by regulators. Unfortunately, in some cases, before the actual advent of biosimilars to the market, legal issues have risen during their developmental stages itself. Well known pharma companies have filed cases against each other to claim their rights and for other legal allegations related to the products.
biopharma’s of investing in a future pipeline. Time is of essence and is the game changer. Biologics/Biosimilars represent over 40 per cent of the drugs in Preclinical, Phase I, Phase II, and Phase III trial stages and as a CRO, we are always excited to work on biosimilars as they are focused, time conscious, quality driven and in almost all cases give us the gratification of witnessing its success and access to patients.
That said, there is no stopping of biosimilars with several big and small
Contact: jayeeta.chowdhury@2020msl.com
FORM IV Statement about ownership and other particulars about newspaper PHARMA BIO WORLD to be published in the first issue every year after the last day of February 1. Place of Publication
Mumbai
2. Periodicity of its Publication
MONTHLY
3. Printer’s Name Nationality 1[(a) Whether a citizen of India? (b)If foreigner, the country of origin] Address
HEMANT K SHETTY INDIAN YES NOT APPLICABLE 406-D, Karachi Citizens CHS, Juhu-Versova Link Road Andheri (West), Mumbai 400 053.
4. Publisher’s Name Nationality 1[(a) Whether a citizen of India? (b)If a foreigner, the country of origin] Address
HEMANT K SHETTY INDIAN YES NOT APPLICABLE 406-D, Karachi Citizens CHS, Juhu-Versova Link Road Andheri (West), Mumbai 400 053.
5. Editor’s Name Nationality 1[(a) Whether a citizen of India? (b)If a foreigner, the country of origin] Address
MITTRAVINDA RANJAN INDIAN YES NOT APPLICABLE 3RD FLOOR, TAJ BLDG., D N ROAD, FORT, MUMBAI 400 001
6. Names and Addresses of individuals who own the newspaper and partners or shareholders holding more than one per cent of the total capital
JASUBHAI MEDIA PVT LTD., 26, MAKER CHAMBERS VI, NARIMAN POINT, MUMBAI 400 021 Maulik Jasubhai Shah, (1100, Shanudeep, 10, Altamount Road, Mumbai 400 026), Maulik Business Services Pvt. Ltd & Jasubhai Business Services P Ltd., (26, Maker Chamber VI, Nariman Point, Mumbai 400 021)
I Hemant K Shetty, hereby declare that the particulars given above are true to the best of my knowledge and belief. Date: 20 th February 2018
Pharma Bio World
Signature of Publisher
March 2018 ► 33
Embracing Digital Transformation to Enhance Insight and Accelerate Discovery This article discusses how digital transformation in the life science industry is critical to finding new opportunities.
P
harma companies have always been in the innovation business. The industry invests billions in research to bring lifesaving treatments to market. Digital transformation — the use of technology to enable new types of innovation and invent modern processes rather than to support traditional approaches — is therefore a natural fit for the life sciences sector and pharma industry. Digital transformation can unleash innovation via technologies such as blockchain, as technology pharma companies are exploring for many applications, including finding candidates for clinical trials and keeping tabs on medications in the supply chain. An immutable digital ledger capable of verifying virtually any type of transaction or process, blockchain functions as a trust engine. Pharma companies require quality data to generate insight and make new discoveries, but, like many businesses, the data they need is siloed in multiple systems with little or no interoperability. Blockchain’s origin as a Bitcoin ledger make its potential as a financial tracking tool obvious, but federal healthcare IT leaders are already exploring its utility in handling clinical trial data. Artificial intelligence (AI) is another technology that pharma and life sciences
Gary Palgon Vice President of Healthcare and Life Sciences Solutions Liaison Technologies 34 ◄ March 2018
organizations are exploring to generate insights and bring new products to market. AI’s automation and data analytics functions, fueled by machine learning, can drive applications that communicate with trial participants via a variety of platforms, including social media and SMS. AI applications can personalize communication with patients, analyze sentiment on social media using natural language processing and deliver critical data to life sciences and pharma companies. Paired with platforms that eliminate data silos and streamline integration and management, AI can help pharma companies obtain crucial insight that drives discovery. Insight is a product of data, but data requires digital transformation to facilitate accurate understanding. Business intelligence tools like data visualization can help reveal insight, but only if the data that generates the visuals is complete and of sufficiently high quality. Incomplete or compromised data yields false insight, and that leads to wasted efforts. To avoid the false insight trap, pharma companies need a way to integrate data from multiple sources — including blockchain and AI — and interpret the information in meaningful ways to improve patient care, streamline
“Pharma companies require quality data to generate insight and make new discoveries, but, like many businesses, the data they need is siloed in multiple systems with little or no interoperability.” Pharma Bio World
operations and lower costs. That requires robust, accurate analytics, which depend on a resilient data architecture to produce prescriptive, descriptive or predictive insights. In the pharma sector, it’s critical to be able to blend research, operational, sales, public health and clinical trial data to generate the insight needed to improve time to market and enable appropriate surveillance. This requires a strong data infrastructure today, plus a future-proof data integration and management strategy
to respond to new sources of information as quickly as they come online. For most pharma organizations, the skills needed to integrate and manage large datasets lie outside the core competencies of the in-house team. Data scientists serve as “data janitors,” spending 80 percent of their time cleaning up information and only 20 percent gleaning insight from it, and IT professionals spend their days programming integration workarounds rather than focusing on more strategic tasks.
Embracing digital transformation, including elements like blockchain and AI technologies, can change that. Cloud-based platforms that enable seamless data integration, management and compliance can flip the 80/20 percent rule around, enabling pharma companies to focus resources on generating insight and accelerating discovery. That’s the true promise of digital transformation.
mreynolds@sspr.com
NOVEMBER 2017 MUMBAI TOTAL PAGES 60
Launched by Chemtech Foundation in 1992, Pharma Bio World (PBW) features contents from Pharmaceutical and Biotechnology industries. PBW provides in-depth information on business practices, latest trends, technologies, research & innovation and processes across the entire industry pipeline.
www.pharmabioworld.com
VOL 16 ISSUE 04
Dear Readers,
VOL 16 | ISSUE 04 | NOVEMBER 2017 | MUMBAI | TOTAL PAGES 60 | PRICE ` 150
PHARMA BIO WORLD
Contribute to PBW
` 150
HYDERABAD - 2017
GUJARAT - 2018
13-15, December 2017 Venue: Hyderabad, India
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India
MUMBAI - 2019
VOL 16 | ISSUE 05 | DECEMBER 2017 | MUMBAI | TOTAL PAGES 60 | PRICE ` 150
www.pharmabioworld.com
VOL 16 ISSUE 05 DECEMBER 2017 MUMBAI TOTAL PAGES 64 ` 150
You are most welcome to share editorial content with us such as technical articles, case studies and product write-ups. The length of the article should not exceed 1500 words with maximum three illustrations, images, graphs, charts etc. All the images should be high-resolution (300 DPI) and attached separately in JPEG or JPG format. Have a look at our editorial calendar on our website www.pharmabioworld.com.
Chemtech Hyderabad World Expo 2017
PHARMA BIO WORLD
Each monthly edition of PBW covers a separate area of pharma and biotech industry and includes articles from a range of peers, consultants and commentators, interview with industry experts, Market research analyzing industry trends, News Features, News Updates, Product Trends, Events Diary and Bookshelf. Target readers for PBW are Drug manufacturers, Intermediates, Pharma machinery/ equipment manufacturers and suppliers, Pharma packaging firms, Research institutes, Academic institutes, Biotechnology firms, Consultants and Government bodies.
GUJARAT - 2018
MUMBAI - 2019
23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India
To know more about Chemtech Foundation, Jasubhai Media and other publications and events, please visit our website – www.chemtechonline.com Thank you, Regards, Mittravinda Ranjan Editor Jasubhai Media Pvt Ltd Tel: +91-22-40373636 (Direct: 40373615) E-mail: mittra_ranjan@jasubhai.com
Pharma Bio World
March 2018 ► 35
Product Packaging and Labeling In recent times, it has become quite straightforward to understand which attribute on the packaging the consumer will shell out more money. The packaging speaks for quality, safety of the food and environment. The increased awareness of environmental conservation and the escalating rate of foodborne illnesses have driven the food industry to implement a more innovative solution, i.e. bioactive packaging.
P
ackaging material has evolved in past 20000 years. The usage of indigenous natural material such as hollow logs, leaves, shells, earthen pots were used to transport the food to smaller distances. Subsequently in 1950’s the use of metals, paper, heat shrinkable plastic came in existence. Plastic as a material has evolved with leaps and bounds to different texture of the packaging material. BPA (Bisphenol A) an industrial chemical used in certain plastic and resins since 1960’s. Substantial amount of scientific evidence show ill effects of BPA in human health. More manufacturers are producing and labelling BPA free products. If a product isn’t labeled BPA free, keep in mind that some, but not all, plastics marked with recycle codes 3 or 7 may be made with BPA. In this argument of BPA, India has forgotten another chemical phthalate that are used to increase the flexibility of plastic. Scientific evidences show the effect on reproductive system in the presence of phthalates. As per European and UK regulatory bodies, tolerable safety limits are put in place for presence of phthalates in food. Although the issue of phthalates in the form polyethylene terephthalate (PET) packaging was ignited in India in the year 2016, no substantial regulation has been put in place in this regard. The threats of few packaging technology to health has enforced large MNC’s like Coco Cola to go back to glass bottle packing from plastic bottles Innovative Packaging
Shruti Kumbla Senior Nutritionist Pristine Organics Pvt. Ltd 36 ◄ March 2018
Tetra Pak is one of the most efficacious innovation that keeps us amazed the
way it maintains the shelf life of the most perishable food item like milk. Unlike traditional inert packaging, active modified atmosphere packaging (MAP) has received a lot of focus in recent years. Active MAP packaging includes oxygen scavenging packaging, humidity-controlled packaging, antibacterial packaging and spontaneous modified atmosphere packaging. Intelligent food packaging is an upcoming technology which involves the ability to sense or measure an attribute of the product, the inner atmosphere of the package or the shipping environment. Intelligent packaging involves indicators, radio frequency identification tags (RFIT) and sensors. This helps in maintaining product food safety, quality and improves the efficiency of supply chain management. The bioplastic materials are more encouraging in the packaging industry when compared to the petrochemical based plastics. More awareness towards environment friendly issues, food packaging industry is constantly innovating new biodegradable materials. Starch based biodegradable packaging material are under research to make its application more feasible in the commercial market. A very interesting innovative research was conducted to produce photo-producible and photo-degradable starch bio-nanocomposite as a packaging material. Now we really know, environment safety has led to more innovation towards biodegradable packaging material which will pose less horrendous impact to the environment and health Pharma Bio World
Scientific research on the production, quality and potential applications of edible/biodegradable films in food manufacturing has been carried out by several research groups worldwide and has been reported in research publications. Edible films formed from whey protein concentrate, alginate, pectin, carrageenan is under trials for commercial purpose. Food Labelling Food labelling generally means putting information on food packaging, labels or collective packaging, which concerns the food packed. This information takes the form of words, letters, logos, images, figures or symbols and may refer to the shelf-life of the product, ways of preparation, consumption, nutritional value or other commercial aspects. The confusion between Best Before and Use by date still exists among the consumers. As per FSSAI, Best before means the date which signifies the end of the period under any stated storage conditions during which the food retains the specific qualities which have been claimed. Beyond the date, the food remains safe for consumption, though its quality may have diminished. Use by date or Expiry date means the date which signifies the end of the estimated period under any storage conditions, after which the food will not be safe for consumption.
made are the healthier option. The consumption of hidden sugar and salt have risen above the limits of WHO guidelines. This system will keep the consumer be more informed. Time temperature indicators gives information on the temperature and shows the variation and history in temperature, visualized as a color change. The commercial available brands are, Fresh Check, VITSAB, MonitorMask (3M). OnVuTM label is one of the temperature indicator. Radio frequency Identification Tags (RFIT) is a new revolutionary data information carrier in comparison to the existing bar code system. RFIT uses electromagnetic fields to automatically identify and track tags attached to objects. The tags contain electronically stored information. Passive tags collect energy from a nearby RFID reader ’s interrogating radio waves. Active tags have a local power source (such as a battery) and may operate hundreds of meters from the RFID reader. Unlike a barcode, the tag need not be within the line of sight of the reader, so it may be embedded in the tracked object. RFID is one method for Automatic Identification and Data Capture (AIDC).
Therefore, beside protective or transport functions, packaging must fulfil the information function, particularly in conditions of a limited involvement of sales staff in trade. Food packaging is an essential marketing tool, the importance of which is reflected both in the performed functions and the role in the process of making decision on purchase by consumers. It is worth remembering that the first contact of a consumer with a product occurs mostly through packaging. The characteristics of packaging often determine the interest in the product. The new innovative packaging helps in improving the food safety and quality. Labelling of products is crucial for ensuring security and reliable nutrition information for consumers. Due to the increasing awareness of the relationship between diet and health, it induces consumers to look for nutrition information and helps to make the right choices, while buying food products. Innovative color code labeling incorporated in the west is the new beginning towards making the consumer an informed buyer.
Conclusion Packaging was traditionally understood as a means of protecting a product in the process of distribution, transport or storage. However, currently, it is increasingly
Internationally, color code system is adopted in mentioning the nutrition information table. These color codes are specifically denoted for fats, saturated fats, sugar and salt. Red stands for high, amber means medium and green means low. This will allow the consumer to see at glance if the food choices Pharma Bio World
becoming an effective way to communicate with the environment. On the one hand, it is a consequence of development of various forms of self-service sales and on the other hand, of the growing consumer demand for information because of the growing nutritional awareness.
Contact: sunanda@pepperinteractive.in March 2018 â–ş 37
marketing initiative
B&R expands Gilgenberg site Automation specialist invests in production, office space and logistics
B&R is investing in its Gilgenberg site, located a few kilometers from the B&R headquarters in Eggelsberg. The expansion adds new offices, training rooms and production space. A new logistics hall has also been opened at the site.
T of
he aim is to establish Gilgenberg
investments
as a competence center for the
production facilities.
development
and
production
electro-mechanical
products.
B&R motors are already assembled there. In the future, Gilgenberg will also host de-velopment and production of
the
intelligent
ACOPOStrak
transport system. B&R’s expansion project in Gilgenberg is in response to increasing demand
in
infra-structure
and
About B&R B&R ZB Group. As a global leader in industrial automation, B&R combines state-of-the-art advanced
technol-ogy
engineering
to
with provide
customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI
for production and office space. To
and integrated safety technology. With
keep pace with its steady growth, the
Industrial IoT communication standards
company is already planning further
like
OPC
UA,
POWERLINK
and
openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations. B&R Industrial Automation
Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com
B&R has added new offices, training rooms and production space at its Gilgenberg site. 38 ◄ March 2018
Pharma Bio World
marketing initiative
Unmatched efficiency with high-speed diverters B&R presents flexible transport system at Hannover Messe
B&R’s new flexible transport system is designed to deliver ultimate production effectiveness – from mass pro-duction down to batches of one. Playing a pivotal role in making this possible are the system’s purely elec-tromagnetic diverters, which are able to divide and merge product flows at full production speed. B&R will be presenting its transport system from April 23-27 at the Hannover Messe in Hall 9, Booth D26. Seamless connectivity
isolated brownfield equipment so it can be utilized by higher-level systems.
The B&R booth will also showcase how OPC UA TSN makes it possible to implement advanced manufactur-ing concepts with seamless connectivity from the field level up to ERP systems. Another Industrial IoT high-light will be B&R’s Orange Box solution. This custom hardware/software package makes it easy to tap into the data of digitally
Industrial PC premiere B&R will be presenting a new generation of compact industrial PCs for the first time at the 2018 Hannover Messe. The PCs offer high performance and an extended array of options for connecting display units.
About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industri-al automation is driven by a commitment to simplifying processes and exceeding customer expectations.
B&R Industrial Automation
B&R will be showing how the high-speed diverters of its flexible ACOPOStrak transport system can significantly in-crease the effectiveness of production lines at the Hannover Messe in Hall 9, Booth D26. Pharma Bio World
Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com March 2018 ► 39
marketing initiative
Digitalization is not an option, but a must B&R India explores IIoT topics at 4th annual Innovation Day
T
he fourth edition of B&R India’s “Innovation Day” once again provided a platform for thought leaders, industry experts and decision makers to share ideas on the Industrial IoT, smart manufacturing, design efficiencies, Industry 4.0 and digitalization. This
In
year’s
announce the launch of its new support
event
welcomed
more
than
200 attendees with a mix of technical
next-generation technologies and move towards smart manufacturing.” addition
to
unveiling
numerous
technological innovations designed to equip machine and plant builders for the future, B&R also took the opportunity to
Industry 4.0 readiness for SMEs in competitive markets. “Ever-changing consumer demands are driving machine complexity – and in turn requiring increasingly complex software,” noted Nikhil Baste, director of Technoshell Automations. “Our software developers are looking for ways to reduce the time spent on both programming and commissioning.”
hotline: “Our world class support further enhances our customer’s experience and discussion – whose members agreed helps them offer their customers faster By encapsulating frequently recurring unanimously that digitalization is not an service and reduced machine downtime,” machine functions in thoroughly tested option, but an imperative step forward for said non-executive chairman PV Sivaram. software components, B&R’s mapp “This will only be possible by utilizing the every organization. Technology helps them do precisely strength of our IIoT-enabled approach.” that. “mapp enables easier maintenance The tone for the event was set by and diagnostics by giving us access to B&R India Managing Director Jhankar Complete solutions, satisfied customers control variables without the need for Dutta: “In order to help our customers dedicated software, special training or achieve their goals of improving Guest speakers from Logindex Solutions, access to source code,” explained Baste. productivity, throughput, quality and Technoshell Automations and Prasad cost-effectiveness, we must adopt Group highlighted various aspects of Industry 4.0 – What is in it for me? presentations, live demos and a panel
The highlight of Innovation Day 2018 was a panel discussion titled “Industry 4.0 – What is in it for me”. The discussion addressed various aspects next-generation Industrial IoT, Industry 4.0 and digitalization technologies. The panelists examined challenges in adoption from the perspective of Indian organizations, as well as the benefits to be gained from successful deployment and the steps they can take to get there.
The members of the panel discussion agreed unanimously that digitalization is not an option, but an imperative step forward for every organization. Left to right: Sudhir Kalkar (GM - Technical, ACG), Rajesh Sharma (GM & Head Manufacturing Eng., Fiat India Automobiles), Yogesh Zope (CIO, Kalyani Group), Deepak Shrivastava (Technical Advisor - IOT, Accurate India), Akilur Rahman (CTO, ABB India) and Jhankar Dutta (Managing Director, B&R India). 40 ◄ March 2018
For details Contact : B&R Industrial Automation Pharma Bio World
news features
Creating an Annual Event of the Biopharma Industry by Focusing on Frontiers, & Promoting Leading Enterprises to Collaborate
T
he Union Budget 2018 was presented on February 1, 2018. Here is how industry experts and leaders from across the A series of significant progress obtained in the biotechnology field over the years has driven the biopharmaceutical industry to seize the high ground for future competition with an innovative development attitude. China’s biopharmaceutical industry has shown unparalleled market prospects. From the perspective of global biological quantity layout, the U.S. has the largest number of biological drugs, followed by China. Behind this, China’s favorable pharmaceutical policy, market environment, and return of overseas R&D personnel, etc. have played the promoting role. Furthermore, biotech drugs have occupied significant shares in each therapeutic area, accounting for one-third among the top 30 drugs by global sales. The market size of China’s biological drug industry was RMB 493.7 billion in 2017, and is expected to reach RMB 853.2 billion by 2020, with compound growth rate of 18.1%, faster than other areas of the pharmaceutical market. Against such background, BioPh China 2018, hosted by UBM EMEA and China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and co-sponsored by Shanghai UBM Sinoexpo International Exhibition Co., Ltd. (UBM Sinoexpo), will be grandly held in Hall W5, Shanghai New International Expo Centre on June 20-22, 2018, which has focused on biotechnology and clinical trials, centrally showcased genetic engineering, antibody engineering, vaccines, and cell therapies, etc., and provided professionals of biopharmaceutical, biotechnology, new 42 ◄ March 2018
drug R&D, and pharmaceutical investment plates, etc. with a leading international development platform for product display, knowledge sharing, technical exchange, and service transformation since 2012. Linking multiple exhibitions, and the upstream and downstream industrial chains of the biopharmaceutical industry BioPh China will team up with the CPhI China 2018 and P-MEC China 2018, to attract over 60,000 professional pharmaceutical visits from 120 countries and regions, gather over 3,000 leading pharmaceutical enterprises to exhibit, and link upstream and downstream biopharmaceutical enterprises, to jointly create an annual legend of the pharmaceutical industry. Focusing on frontier technology trends, with the participation of over 110 biopharmaceutical exhibitors To enable the pharmaceutical peers to hold
conversations with the biopharmaceutical industry more efficiently, BioPh China 2018 will further expand exhibition fields to include biotechnology, diagnostic reagents, and bioengineering, etc. based on biotech drugs (production and R&D of blood products, vaccines, genetic engineering, and antibodies, etc.), and biopharmaceutical APIs (production of protein, enzyme, peptide, and amino acid, etc.), to create a one-stop industry exchange platform for biopharmaceutical and technical services. Faced with the 2018 exhibition space with more diverse content and richer levels, old exhibitors including Hualan Bio, Gan & Lee Pharmaceuticals, 3SBio, Dongbao Enterprise, Changchun Changsheng, Mellow Hope, GeneScience Pharmaceuticals, Peking University Sinobioway, Chinese Peptide Company, Amoytop Biotech, SL Pharmaceutical, and Zhejiang Peptides Biotech, etc. have already renewed stands in 2017, and will present a dazzling annual
2017 site: linking multiple exhibitions to build an annual event of the biopharmaceutical industry Pharma Bio World
news features audio-visual feast of the industry to the visitors together with over 110 Chinese and overseas famous biotechnology and pharmaceutical enterprises on the exhibition site with cutting-edge products and frontier technologies. Full support from Chinese and overseas professional associations, to build a high-end pharmaceutical R&D summit. BioPh China will continue the “exhibition” and “conference” combination mode on the site in 2018, and specially set up two conference and activity areas, to hold theme summit and professional forum, etc., focus on hot topics in biopharmaceutical R&D, follow closely the international frontier situation, and construct an information exchange platform integrating trade, networking, and knowledge exchange for the insiders. As an ace conference of the exhibition every year, the 5th China BioPh Outlook Summit will be jointly held by CCCMHPIE,
Shanghai Biopharmaceutics Industry Association (SBIA), Sino-American Pharmaceutical Professionals Association (SAPA), and UBM Sinoexpo in 2018, to together create an industry gathering with more professional content and more comprehensive topics. This summit will attract hundreds of industry leaders to discuss Chinese and overseas biological drug markets and policies, innovative biological drug R&D, anti-cancer drug R&D, and tumor immunotherapies, etc., where, Dr. Chen Shaoyu, former Assistant Chief Counsel of the U.S. FDA, and Dr. Liu Shigao, CEO of Shanghai Henlius, etc. will form a star guest speaker lineup, to share respective experience with the attending guests. During the summit, the host will subdivide the industry into sections, and hold forums on insulin, growth factor, antibody, and vaccine, etc. together with leading pharmaceutical enterprises, to convey latest industry information to the visitors.
SBIA, the leading organization in the pharmaceutical field of China, will host the “antibody forum” on the site this year, and invite Chinese pioneer enterprises in antibody drug R&D and manufacturing to the site to discuss process development and quality control of antibody drugs. Furthermore, CDMOs have become indispensable partners of pharmaceutical innovation enterprises, especially the antibody R&D companies. The DrugRNDer CDMO Forum will also be held on the exhibition site on June 20, where the host will invite leading CDMOs to analyze the production and development experience.
Contact :
Exhibition and activity sponsorship: Jackie, Cindy Tel: 010-5803 6339, 021-3339 2252 Email: lihua@cccmhpie.org.cn, cindy.tan@ubmsinoexpo.com Media cooperation: Rosy, Alice Tel: 010-5803 6315, 021-3339 2421 Email: tuxiaoying@cccmhpie.org.cn, alice.huang@ubmsinoexpo.com
Now : Mobile App of Pharma Bio World For Android & Apple Platforms Download FREE App from
NEXT ISSUE FOCUS >>
Arial NarrowExcipients are crucial to drug delivery within the body. Generally, an excipient has no medicinal properties. Its standard purpose is to streamline the manufacture of the drug product and ultimately facilitate physiological absorption of the drug. Excipients might aid in lubricity, flowability, disintegration, taste and may confer some form of antimicrobial function. In the April issue of Pharma Bio World, themed on Excipients will cover articles, case studies and guest columns which could focus on broad areas of the issue theme.
To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback. Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.
Pharma Bio World
March 2018 ► 43
press release Eli Lilly Appoints Luca Visini MD for IPA Conducts Training Sessions at IPC its Operations in India The National Coordination Center (NCC) for Pharmacovigilance Multinational biopharmaceutical leader, Eli Lilly and Company, announced earlier this year the appointment of Luca Visini as Managing Director of its Indian subsidiary, Eli Lilly and Company (India) Pvt. Ltd, effective February 1, 2018. Visini replaces Edgard Olaizola, who headed Lilly India operations from September 2013 to January 2018 and will now be moving internally to a new role. Visini joined Lilly in 2004 and held several strategic leadership roles in various functional departments out of Lilly headquarters in Indianapolis, the USA and Europe. From 2011 to 2014 he was the country manager for Lilly Romania. He is taking this executive role endowed with a diverse and solid management experience at Lilly. Visini is a native of Italy, and an alumnus of SDA Bocconi School of Management and Università degli Studi di Bergamo in Italy.
Premas Life Sciences, IncellDx Sign Distribution Deal Premas Life Sciences Pvt, Ltd and IncellDx, Inc have signed an exclusive distribution agreement. The commercial partnership brings the power of cell by cell multiplex diagnostics for solid tumors carcinomas that can now be analyzed for molecular and protein biomarkers by flow cytometry. Included in the deal are: IncellDx’s patented single-cell assays for quantifying PDL1 on tumor cells and immune cell subtypes; patented singlecell assay for HPV E6/E7 mRNA detection in cervical samples; and, its incellPREP single-cell preparation kit for solid tissues including tumors. Researchers at AIIMS, New Delhi have completed a successful study utilizing IncellDx’s next generation (3Dx) investigational molecular assay which quantifies E6, E7 mRNA overexpression in single cells simultaneously with the measurement of cell cycle and cell proliferation, the hallmark of progressive disease. IncellDx is a molecular diagnostics company dedicated to revolutionizing healthcare one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, the company’s focus is on critical life threatening diseases in the areas of cancer, specifically lung, cervical, head and neck, bladder, cancers. 44 ◄ March 2018
Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare, Government of India, Ghaziabad, Uttar Pradesh (U.P.) organized Skill Development Programme (SDP) on “Basics and Regulatory Aspects of Pharmacovigilance – Optimising Medicine Safety is our Goal” from January 15-24, 2018 at Conference Hall of IPC, Ghaziabad. The Pharmacovigilance (PV) programme is conducted every year to accomplish SDP in the country under the government’s ambitious Pradhan Mantri Kaushal Vikas Yojana. The objective of the workshop was to enhance the knowledge and skill of qualified PV professionals to ensure better patient safety as per the requirement of Schedule Y of Drugs & Cosmetics Act, 1940 and to enhance career prospects & employment opportunities in PV in government as well as in private sector. The target group for the programme was young pharma / medical / paramedical professionals seeking career in PV and existing professionals in PV. Faculties drawn for the programme were renowned experts from government teaching & corporate hospitals, regulatory authority, WHO, pharmaceutical industry, academia and research institutions.
LifeCell Initiates Development of Large Scale Manufacturing of MSCs LifeCell, India’s first & largest stem cell bank in the country, a pioneer in stem cell research has embarked on a journey to develop large scale manufacturing of Mesenchymal Stem Cells (MSCs). Mesenchymal Stem Cells are one type of master stem cells that have the potential to form bone, cartilage, muscle and adipose tissues, thereby making them capable of being used in the several therapeutic areas. Importantly these MSC’s can be made available off-the-shelf for immediate treatment as they don’t need donor-recipient matching. The potential of these MSCs of medical conditions are being checked in 50+ clinical trials around the world, with several companies like TiGenix, Mesoblast, etc., are also receiving market approvals in many countries such as Europe, Canada, Japan, and Australia. Even in India recently, the DCGI provided a limited approval to Stempeutics to market their MSC product for treatment of Critical Limb Ischemia Pharma Bio World
press release Sanofi Launches New Insulin Toujeo Historic Deal Signed Between Panacea in India Biotec & Serum Institute of India Sanofi India continues to deliver breakthrough medicines for the management of diabetes with the launch of its new product Toujeo, the next generation basal insulin. Toujeo is a once-daily, long-acting basal analog insulin that improves glycemic control in adults with type 1 and type 2 diabetes. Low blood sugar, or hypoglycemia is a constant fear amongst people on insulin. Toujeo has demonstrated that it effectively lowers blood glucose, while minimizing the risk of hypoglycemia. It works by slowly releasing small amounts of insulin to provide continuous glucose-lowering activity that lasts beyond 24 hours. With its stable and flat/peak-less action profile, Toujeo reduces glycemic variability, i.e. the daily highs and lows that people with diabetes on insulin may experience. The product also comes with an impressive MY COACH patient support program (offered free to patients prescribed Toujeo). This patient support program provides six comprehensive months of hand-holding patients through their treatment journey - tips on diet and lifestyle, training on injection techniques, sugar monitoring and more, via a mix of telephonic and in-person sessions. MY COACH will be offered under Sanofi’s Saath-7 initiative, the longest running patient support program in India, which has serviced more than 4,12,000 people with diabetes on insulin till date.
Panacea Biotec Ltd. (PBL) is delighted to announce the collaboration with signing of two long term agreements with Serum Institute of India Pvt. Ltd. (SII) and SII’s wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO). Under the collaboration SII is entitled to manufacture & sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-HibIPV) developed & commercialized by Panacea Biotec, a first of its kind in this category. WHO prequalified IPV is essential to successfully eradicating Polio across the globe, an effort that has already cost USD 20 Billion worldwide. There is a Global Polio Eradication Initiative (GPEI) in place & Global Alliance for Vaccine Initiative (GAVI) has been supporting the program since 2013 having allocated USD 430 Million till 2018 with an additional donor pledge of USD 23 Million for 2019. At present GAVI is evaluating IPV under Vaccine Investment Strategy for Global Public Good. Global demand of IPV/ IPV containing vaccines is estimated to rise significantly from ~100 Million in the year 2020 till supply constraints remain, to 250-350 Million doses every year starting 2022 depending upon a two or three dose schedule as Strategic Advisory Group of Experts (SAGE) on Immunization in April 2017 has recommended at least 2 doses of IPV in the routine Immunization schedule of the countries post OPV withdrawal.
Lupin Forays into OTC Segment with Softovac Dr. Reddy’s Launches Tetrabenazine Pharma major Lupin Limited (Lupin) has made a foray into the Tablets in the US Market over-the-counter (OTC) segment under the ‘Lupin Life Consumer Healthcare’ umbrella with the pan-India launch of Softovac. A 34-year old legacy brand, Softovac has been trusted by millions of consumers who suffer from constipation and irregular bowel habits.
Pegged at over USD 2.7 billion (INR 18862 crores) as on 2016 as per Nicholas Hall 2017 report , the Indian OTC market is expected to grow at a CAGR of 9 percent to cross the USD 6.5 billion (INR 44115 crores) mark by 2026. Softovac’s shift to OTC was piloted in West Bengal during which the brand witnessed a growth in sales of over 25 percent, and post the success of the pilot, a pan-India roll-out was initiated. Softovac is a bowel regulator made with 100 percent natural actives like Isabgol, Sonamukhi, Harad, Mulethi, Gulab dal (ingredient), Amaltas, and Saunf, all of which are time-tested ingredients known to provide effective relief from constipation and irregular bowel habits. Pharma Bio World
Dr. Reddy’s Laboratories Ltd has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine (tetrabenazine) in the United States market approved by the US Food and Drug Administration (USFDA). The Xenazine brand and generic had US sales of approximately USD 322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health. Dr. Reddy’s Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112. Xenazine is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L. March 2018 ► 45
Pharma News Peripheral ExeGi Pharma Launches Visbiome Vet XableCath’s ExeGi Pharma LLC, a biotechnology company, has launched Catheters Gets US Patent Visbiome Vet, a new high potency probiotic for use in companion dogs to help support normal inflammatory responses in the gastrointestinal tract (GI tract) and to help normalize gut health.
The formulation in Visbiome Vet contains an eight-strain proprietary probiotic blend that has recently been studied in several canine GI disorders, with two clinical trials published in the last 12 months. Visbiome Vet is the identical formulation to Visbiome, a human medical food that has been the subject of over 60 clinical trials. Visbiome Vet contains 112.5 billion live bacteria per dosage, a potency that far exceeds other conventional veterinary probiotics. The product, only available to veterinarians and veterinary pharmacies, is packaged conveniently for veterinary applications. Visbiome Vet is shipped and stored only under refrigerated conditions to ensure maximum product potency.
MYR Pharma Completes Phase 2b Study of Myrcludex B MYR Pharma GmbH, a German clinical stage biotech company, announced the completion of its MYR 202 clinical trial, a phase 2b study investigating Myrcludex B in chronic hepatitis Delta (HDV), the most severe form of viral hepatitis that currently has no satisfactory treatment options. A total of 120 subjects were enrolled into MYR 202 in 20 centers in Russia and Germany, which makes it the world’s largest HDV clinical study. The results of the study will be presented at the General Session of the upcoming International Liver Congress, an annual meeting of the European Association for the Study of the Liver (EASL) in Paris, France on April 12, 2018. Myrcludex B is a first-in-class entry inhibitor for the treatment of chronic hepatitis B (HBV) and its co-infection hepatitis Delta. The drug inhibits the recently identified HBV receptor on the hepatocyte surface and prevents the infection of the healthy cells and viral spreading within the liver. The drug has received Orphan Designation for treatment of HDV infection from the EMA and FDA, and PRIME scheme eligibility from the EMA. MYR Pharma GmbH is a German clinical stage biotechnology company focused on the development of drugs for the treatment of chronic hepatitis B and Delta virus infections. 46 ◄ March 2018
Arterial
XableCath, Inc., innovators of products designed to aid in the treatment of peripheral artery disease, announced that it has been granted a second US Patent, No. 9,826,995, covering its XableCath catheter. The patent specifically describes a catheter that controls tissue contact and has a rigid ring implement that opens a blood vessel occlusion by rotating the ring against the occlusion, thus clearing the vessel and providing access across the lesion. Peripheral arterial disease (PAD) is a disease of the arteries that carry blood to the limbs. Diseased arteries narrow or are blocked, thereby restricting adequate blood flow to reach peripheral extremities beyond the obstruction. PAD is the major cause of limb amputations, affecting more than 200 million people worldwide -- including 27 million people in Europe and the United States. Most amputations can be prevented with appropriate treatment. The XableCath support catheter is designed to treat PAD by facilitating over-the-wire passage through the true artery lumen enabling endovascular treatment options such as angioplasty, stenting, or atherectomy. XableCath technology is designed to modify atheroma edges facilitating rapid and safe passage across tough arterial lesions in the peripheral vascular.
Avillion Inks Drug Development Deal with Pearl Therapeutics Avillion, a drug development company, has signed a clinical codevelopment agreement with Pearl Therapeutics Inc., a wholly owned subsidiary of the AstraZeneca Plc group, to advance PT027 through a global clinical development programme for the treatment of asthma. PT027 is an investigational fixed dose combination of budesonide (an inhaled corticosteroid) and albuterol (a shortacting beta-2 agonist). Avillion will be responsible for developing PT027 through an extensive clinical development programme and will finance the programme through to regulatory approval. No financial terms are disclosed. Avillion is a drug development company with an innovative business model focusing on the clinical co-development and regulatory approval of pharmaceutical products. Pharma Bio World
Conta-bin/Container Tumbler Blender Bin blenders or container tumblers are used mainly for blending of dry powder for tablet production and capsule, which facilitates better flow for tablets and capsules. They are available in Model 5 to 1,000 litre working capacity with different size of container. Bin shape product container is ideal for dry mixer for lubrication of granules and homogenization mixing of multiple batches into single batch. It has interchangeable bin with different capacity; closed and contained system for blending, storage and transfer; hydraulic system for lifting of product container for mixingOptional features include PLC controls and FLP. For more information, please contact:
Prism Pharma Machinery Plot No: 37/13, Phase IV, GIDC, Vatva Ahmedabad, Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com / slaes@ prismpharmamachinery.com
GPC/SEC Gel Permeation Chromatography/ Size Exclusion Chromatography (GPC/SEC) is the technique of choice for rapid and reliable characterization of molecular weight and molecular structure for all types of macromolecules – proteins, natural polymers and synthetic polymers. At the heart of the range are the Viscotek advanced GPC/ SEC systems, including the powerful TDAmax system with OmniSEC software: Viscotek TDAmax – integrated, temperature controlled GPC/SEC system; Viscotek 270 max – modular, ambient temperature GPC/SEC system; Viscotek RImax – modular conventional GPC/SEC system; and Viscotek HT-GPC – high temperature system for polyolefin analysis. For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road, New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com
Coating Pan Contact pan is available in standard cGMP and customised models with SS-304/316/316L contact parts. Extensively used for sugar and film coating of tablets, pallets and granules. It comprises of ellipsoidal shaped pan fabricated using SS plate, mounted on gearbox shaft, driven by an electric motor. The complete drive unit is enclosed in a sturdy unit. Heaters are interlocked with the blower motor, therefore unless the blower is on, the heater does not start. It has a modern PLC-operating system and available in Model 12”, 18”, 24”, 30”, 36”, 48”, 60” and 72 inch. For more information, please contact:
IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com
Pharma Bio World
March 2018 ► 47
Liquid Analysis
Liquid Analysis Liquiline is the platform for all liquid analysis applications. It forms the basis of their ultra-modern transmitters, samplers and analysers.
Liquiline is the platform for all liquid analysis applications. It forms the basis of their ultra modern transmitters, samplers and analysers.
Liquiline CM44 is the most flexible transmitter for all Memosens sensors. It measures twelve different parameters and allows up to eight sensors to be connected. Liquiline CM44 is available as a field device and also for mounting in control cabinets and on DIN rails.
Liquiline M CM42, the two-wire transmitter for the parameters pH/ORP, conductivity and oxygen, impresses with reliable data transmission and easy operation. It can be used in all areas of process automation including hazardous areas and hygienic applications.
For more information, please contact:
Endress+Hauser (India) Pvt Ltd 7B, 7 th Floor, Godrej One Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com
For more information, please contact:
Endress+Hauser (India) Pvt Ltd 7B, 7 th Floor, Godrej One Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com
Vacuum Transfer System Vacuum transfer system is available in standard cGMP and customised models with SS304/316/316L contact parts. Capable of vacuum conveying of up to 2,700 kg/hr of material at distances up to 300 ft. It is ideal for long distance conveying and where product degradation is a concern. Assure dust-free operation since the product is conveyed under vacuum. Designed to meet sanitary standards and provides hygienic transfer of materials. VTS represent a more intelligent method of cleaning and removing materials from large tanks. Available in all ranges suiting client’s requirements. For more information, please contact: IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com marketing@ipecengg.com
48 â—„ March 2018
Pharma Bio World
Dynamic & Static Pass Boxes Dynamic pass boxes are designed in conformation to the intenational standards are used for transferring the material through controlled environment to different classified area to avoid cross-contamination and maintain integrity of product and process. Static pass box is suitable to avoid cross-contamination between different classified areas and to maintain integrity of products and process while transferring material. Static pass boxes are used to transfer material without much personal movement between different classified areas and avoiding particulate contaminations.
For more information, please contact: Vishwakarma Industries Plot No: 136/H1, Phase II, GIDC Vapi, Dist: Valsad, Gujarat 396 195 Fax: 91-0260-2450404 E-mail: vishwakarma_vapi@hotmail.com
End-suction Centrifugal Pump Strength, efficiency and reliability are the hall mark of MBH end suction centrifugal pump range. These powerful single stage pumps are designed to work hard in most demanding building and industrial environments, where only the fittest pumps can survive in the long run. All pumps are designed to comply with DIN 24255 and ISO 2858. Over the years the pumps have been carefully optimised and refined to offer unsurpassed energy efficiency and performance. The impressive range of MBH end-suction pump is compatible with an array of application areas including water intake; HVAC; cooling towers; general process water; cold and hot water transfer; fire fighting; industrial liquid transfer; filter systems and ultra filtration. Pumps supplied with special HVAC controller as well as VFD.
For more information, please contact: MBH Pumps (Gujarat) Pvt Ltd Plot No: 14, GIDC Indl Estate Naroda, Ahmedabad, Gujarat 382 330 Tel: 079-22823066, 22821018 E-mail: marketing@mbhpumps.com
Air-to-Air Heat Exchanger APPIDI Energy Recover Units (ERU) heat recovery is a plate or rotary type air-to-air heat exchanger designed to provide max energy efficiency in ventilated systems where heated or cooled air is let out and outdoor air is let in. In applications where ventilation is required or recycling of the same air is not allowed, energy recovery wheels or plate heat exchangers are used to recover the energy from exhaust air. This reduces the initial investment in HVAC equipment and minimises operating cost. Since HVAC equipment is typically the largest source of energy consumption in commercial buildings, ERU investments are economically justified for outdoor at makeup. In new HVAC installation, ERUs also allow ventilated systems to be sized with smaller compressors, lowering initial costs of the HVAC package. For more information, please contact: APPIDI Technologies Pvt Ltd Survey No: 123, Jeedimetla Village Qutbullapur Road Hyderabad, Telangana 500 055 Tel: 040-65863942 E-mail: sales@appiditech.com
Pharma Bio World
March 2018 â–ş 49
Liquid Analysis
Capsule Hand Filling Machine
Liquiline is the platform for all liquid analysis applications. It forms the basis of their ultra modern transmitters, samplers and a n a l y s e r s . Liquiline CM14, the four-wire transmitter for pH/ORP, conductivity and oxygen, is an instrument used for straight forward measuring tasks. The compact design of the Liquiline CM14 makes it suitable for use in panels or control cabinets, and it is a particularly attractive solution for plant manufacturers.
For more information, please contact:
Endress+Hauser (India) Pvt Ltd 7B, 7 th Floor, Godrej One Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com
Capsule hand filling machine is the most versatile capsule filling machine suitable for all types of manufacturers. This machine is GMP compliance with low rate of rejection. Features output up to 60,000 to 65,000 capsules per 8 hour shift; easy to operate and user-friendly; SS-304 quality hard chrome plated parts are also easily available; interchangeable, can be used for 00, 0, 1, 2, 3, 4, 5 capsule sizes.
For more information, please contact: Pharma Chem Machineries 311/2484, Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com pharmachem79@gamil.com
Ion Trap Mass Spectrometer With the improved robustness of Generation 2 ion optics, the Thermo Scientific Velos Pro ion trap mass spectrometer delivers reliability on the fastest most sensitive, highest capability ion trap available today. New detection electronics enable linear quantitation of up to 6 orders of magnitude for enhanced reproductivity and confidence in results. Fast scanning up to 66,000 Da/sec enables ultra high-throughput analysis, compatible with UHPLC systems. Trap-HCD fragmentation offers complementary, triple quadrupole-like fragmentation that facilitates structural elucidation, sequence assignment and quantitation of isobarically labelled peptides. For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104 Delphi, C-Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 Fax: 91-022-67429495 E-mail: sagar.chavan@Thermofisher.com
50 â—„ March 2018
Pharma Bio World
Remote Viable Air Sampling Active microbial air sampling can be added as an integral part of facility monitoring solution, removing the need for using portable air samplers and providing secure logging of viable sampling program timing to support batch release. Continuous or interrupted active air sampling regimes are supported. The internal impeller fan speed is monitored and controlled to ensure the correct sample volume and d50 values are maintained. Active air samples are available with a variety of mounting and sample head options. For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com
Sunmill Wet The Sunmill wet is a conical screen mill. A high speed rotating impeller forces the product through the perforation of fixed cone shaped screen. The product discharged from the bottom of the mill is reduced in size. It is GMP compliance with low heat, low dust and low noise. Av a i l a b l e i n R & D M o d e l s S M W 5 0 0 a n d P r o d u c t i o n Models MW 1000 and SMW 2000. For more information, please contact: Sunsai Pharma Eqpt Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Sativali Road, Vasai (E), Thane Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com sunsaipharma@gmail.com
Octagonal/Double Cone/V-shape Blender Blenders are used for mixing, lubricating and blending in pharma, nutraceutical, foods, chemicals, cosmetics, ceramics, pesticides, plastics and other allied industries. They are available in Model 2 to 5,000 litre working capacity with different shape of container. Octagonal/double cone/V-shape/bin shape product container is ideal dry mixer for lubrication of granules and homogenization mixing of multiple batches into single batch. Features closed loading and unloading, VFD, PLC controls, FLP and intensifier with VFD For more information, please contact: Prism Pharma Machinery Plot No: 37/13, Phase IV, GIDC, Vatva Ahmedabad, Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com
Pharma Bio World
March 2018 â–ş 51
Cell Viability Analysis
Shutoff & Divert Valves
The Vi-CELL Cell Counter for cell viability analyser provides an automatic means to perform the trypan blue dye exclusion method, allowing users to load up to 10 samples at once for easy and automated cell viability analysis. The cellular analysis system can be customised to ensure consistent and accurate cell counts for simple systems such as CHO cells and more complex samples such as yeast. Cell viability analyser provides an automatic means to perform the trypan blue dye exclusion method. Load up to 10 samples at once for easy and automated cell viability analysis. ViCELL XR intelligently distinguishes between live and dead cells for a wide range of cell types. Programable cell types with control over the cell sphericity, colour and size. For more information, please contact:
Cipriani Harrison’s pneumatic valves are made from forged SS-316L/SS-304L are highly polished and come standard with PTFE and FDA EPDM seals. These valves have selfdraining machined bodies with a round shape that allows for a minimum resistance to flow. The valve body, yoke and actuator are assembled with clamps enabling quick and easy assembly and disassembly. Available in sizes 1-4” with sanitary clamp and Butt-weld and connections as standard. Multiple body styles and electrical control tops are available for varying applications. These are 3A authorised and user-friendly. Electronic control caps are available for communication/automation. For more information, please contact:
Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com
Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nager, Anand, Gujarat 388 121 Tel: 02692-235082, 235182 Fax: 91-02692-236385 E-mail: info@harrisonengineers.com
Centrifugal End Suction Pumps MBH Pumps offers state-of-the-art fire pumpset with diesel engine or motor driven horizontal end-suction pump. These pumpsets are typically used in fire fighting applications for supplying water to fire hose reels, fire hydrants or sprinkler systems. Pumps have a discharge up to 2,900 USgpm and the head range up to 230 psi. These fire pumpsets meet or exceed the requirements of NFPA20. Installations of these pumpsets would ensure the safety of human life, buildings, expensive plants and equipment. The fire pumpset typically consists of the following equipment: pump, motor or diesel engine assembled with cooling, fuel, battery and exhaust systems; fire pump controller; suction and discharge gauge; air relief valve; and common base plate. For more information, please contact: MBH Pumps (Gujarat) Pvt Ltd Plot No: 14, GIDC Indl Estate Naroda, Ahmedabad, Gujarat 382 330 Tel: 079-22823066, 22821018 E-mail: marketing@mbhpumps.com
52 ◄ March 2018
Pharma Bio World
Mixproof Valves
Air Shower
Cipriani Harrison’s mixproof valves are made from forged/bar stock AISI 316L and 304L. Double seat valves are used in automated multiple routing systems with absolute confidence. Modern production processes demand simultaneous operation of product and cleaning cycles in order to maximise productivity and optimise operations. The construction of the valve guarantees that all products and cleaning liquids, in complex routing systems, remain separated, even in the event of seal failures. Available sizes ranges from 1-4”. Electronic control caps are available for communication/automation. For more information, please contact:
Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nager, Anand, Gujarat 388 121 Tel: 02692-235082, 235182, Fax: 91-02692-236385 E-mail: info@harrisonengineers.com
Laminar Air Flow
For more information, please contact: Vishwakarma Industries Plot No: 136/H1, Phase II, GIDC Vapi, Dist: Valsad, Gujarat 396 195 Fax: 91-0260-2450404 E-mail: vishwakarma_vapi@hotmail.com
Automated Viscosity Measurement Laminar air flow cabinets are designed for creation of a bacterial dust-free air space. The work area is continuously supplied with positive pressure horizontal airflow and prevents contamination from operator and environment to work area. Airflow cabinets are used for work with low risk substances and material.
For more information, please contact:
Vishwakarma Industries Jagat Khanna, PO Manjholi, Tehsil: Nalagarh Dist: Solan, Himachal Pradesh 174 101 Tel: 01795-265318 Fax: 91-01795-265319 E-mail: vishwakarma.hp@gmail.com
Pharma Bio World
Air shower is designed to supply Class 100 HEPA filtered air at high velocity helps remove particulate matter from the personnel entering into the clean room. Air shower works as partial clean equipment installed at the partition between the clean room and non-clean rooms to shower the personnel or matter before entering the clean area. This unit helps to remove dust effectively and maintains the normal working status. Air shower is available in various standard dimensions, also their cabinet can be custom engineered to fit any size. These units are available in powder coated mild steel/SS-304 or combination of both.
The Viscosizer 200 is an innovation in automated viscosity measurement and molecular sizing using very small sample volumes. This instrument is ideally placed to serve those working within biopharma, preformulation and formulation development, which need rapid viscosity information on a large number of low volume samples, in order to assess candidate developability. For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road, New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com
March 2018 ► 53
Tri-Clover Gaskets
IonTrap Mass Spectrometer
Tri-Clover Gaskets are used for connecting two pipes in food and drug plant. Tri-Clover Gasket is available in Food Grade Silicon, Food Grade Viton, Food Grade EPDM, etc. It can be supplied in different sizes upon request. Tri-Clover Gaskets is made from Platinum-cured Silicone Rubber, Fluoro Elastomer (FKM), EPDM and PTFE. It conforms to FDA 21 CFR.177.2600 and USP Class VI requirements. It is Animal Derived Ingredient Free. Silicone TriClover Gaskets are available with collar for better grip and also without collar. It is available in red/orange/white and transparent colour.Imaclamp has different types like T/C gaskets, Mesh T/C gaskets, PTFE Envelop gaskets, Sensor T/C gaskets and Validation T/C gaskets. For more information, please contact:
Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E), Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com
Thermo Scientific LTQ XL ion trap LC-MS mass spectrometer delivers high-sensitivity MS performance to generate extensive structural information for routine proteomics and metabolism application. Its high capacity 2D linear ion trap configuration with powerful software is a complete solution for structural elucidation questions. The LTQ XL MS offers multiple dissociation techniques, PQD, ETD and CID. PQD is a proprietary technique that eliminates the low mass cut-off concern inherent with all ion traps. It gives extensive coverage for predicted and unpredicted metabolites. For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104 Delphi, C-Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494, Fax: 91-022-67429495 E-mail: sagar.chavan@Thermofisher.com
High Speed Doors Prime King is oversized design for large openings - unique folding design and strong lifting belts, constructed of polyester, wear and traction-resistant can operate in the most diverse situations even in windy conditions. Resistance to wind load is according to EN 12424 Class 2/3, and size up to 15,000 x 10,000 mm (W x H). Integrated motorisation for very heavy duty use: 400 V three phase, opening speed up to 2.0 m/s. It has a galvanised steel structure as Standard, SS structure, which integrates traction unit, rapid wirings and safety photocells. Reinforced flexible curtain in self-extinguishing material fitted with strong tubes to ensure proper door functioning in large openings and wind exposed areas. For more information, please contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre Link Road, Malad (W), Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in
54 â—„ March 2018
Pharma Bio World
Rapid Mixer Granulator
Linear Liquid Filling Machine The RMG is a rapid mixer and granulator with specially designed Z Type Impeller and high shear chopper blades for efficient dry mixing and wet granulation in an enclosed bowl with GMP compliance.
Available in R&D Models 1, 2, 3, 5, 10 and 15 litres and Production Models 30, 60, 150, 250, 400, 600, 800, 1,200 and 1,600 litres. For more information, please contact:
Sunsai Pharma Eqpt Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Sativali Road, Vasai (E), Thane Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com / sunsaipharma@gmail.com
The Nihira NP-LLF Series of machine is for filling of all type of liquid foods and pharma/chemical liquids. The machine is suitable for filling of glass/PET/PP bottles and jars used in packaging of foods and also variety of container used in cosmetics filling. It features easy and fast changeover for different size of bottles; no bottle no filling safety device; volumetric filling by piston pump driven by pneumatic or servo motor; etc. In servo driven filling, volume can be adjusted with touch screen. Machine is constructed in SS-304. For more information, please contact: Nihira Food Engg LLP Plot No: 185, Sector No: 07, PCNTDA Bhosari, Pune Maharashtra 411 026 Tel: 020-66350099 E-mail: santosh@nihira.in santoshkarale@yahoo.com
Automatic Inspection-Cum-Polishing Machine (Twin Stage) Another useful product is automatic capsule inspection with polishing (in two stages). It has two polishing chambers with 6 inch of inspection belt. Features output up to 50,000 to 60,000 capsules per hour; feeding section is compatible with stainless steel hopper and vibrator with powder collector; inspection section is compatible with conveyor belt with different speed drive; defect capsule sort out manually by pluckers or by hand; polishing section is compatible with two stainless steel chambers, installed with filter cloth and nylon brush. For more information, please contact: Pharma Chem Machineries 311/2484, Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com pharmachem79@gamil.com
Pharma Bio World
March 2018 â–ş 55
events diary Date: 17 th – 18 th May 2018 Venue: Shanghai, China The 2018 China International Pharma 4.0 Summit will bring together over 300 delegates from relevant governments, associations, institutions, pharmaceutical manufacturers, pharmaceutical equipment suppliers, intelligent solution providers of pharmaceutical, packaging, warehouse and logistics, among those the industry regulators, experts and opinion leaders will share the latest policies and regulations, global market trends, technical innovation in the whole chain of drug production, architecture and practice of intelligent pharmaceutical plants as well as advanced technologies such as robotics, AI, informatization, IoT, big data, cloud computing, comparing notes on the transformation and upgrading of pharmaceutical industry.
Date: 24 th – 25 th May 2018 Venue: Sheraton Grand Bangalore Hotel at Brigade Gateway, Bengaluru, India The Biomarkers India, organized by the SELECTBIO will take place from 24th May to the 25th May 2018 in Bangalore, India. The conference will cover areas like bioinformatics & big data analytics for biomarkers development, biomarker discovery & identification techniques, biomarkers in drug discovery & development and many more. Maninderjit Singh, Exhibition Manager Ph: 7696225050 Email: mjsingh@selectbio.com
Patrick Chow Ph: +86 21 6485 6566 – 614 Email: patrick.chow@borscon.com
Date: 20 th – 23 rd February 2019 Venue: Bombay Exhibition Center, Mumbai
Date: 23 rd -24th May, 2018 Venue: Montreal, Canada Biopharmaceutics 2018 is an international platform for sharing knowledge and representing work in the field of Challenges in Biopharmaceutics, Biopharmaceutical Drug Discovery & Development, Clinical Trials in Biopharmaceutics, BA/BE Studies, Biosimilars & Biologics Drugs and more under the theme “Addressing the Challenges in Biopharmaceutics and Biological products”. The conference aims at promoting interaction among the researchers, students, industrial professionals, Biologists, exhibitors, professors and pharmacists from all around the globe. It is a campaign to create awareness about the recent advancements, researches, breakthroughs, technology developed in the area of Biopharmaceutics: Research Scope and Prospects, Novel Approaches in Biopharmaceutics. Biopharmaceutics 2018 will serve as a motivation for the young scientists. We invite you to join us with your prestigious studies & together we will make this world a better place to live. Office Ph: +1-888-843-8169 Toll No: +1-800-216-6499 (USA & Canada) Email: biopharma@alliedmeetings.com biotherapeutics@alliedmeetings.com
56 ◄ March 2018
BioPharma World Expo 2019 will be a perfect destination for Bioprocess Solution Providers, CROs/CMOs, Clinical Trial Supply Chain Providers, Cold Chain Packaging & Cargo, Global Pharma, Regulatory Consultants, Analytical Instrument Manufacturers, Local Biotechs & Start-ups, Quality Control Consultants, Academics, and Regulators to showcase and promote their product and services as well as offer unique opportunity to meet, network and discuss current industry trends, establish business partnerships and be updated on investment opportunities in India. The concurrent conference tracks will explore areas like biosimilars and vaccines development, antibodies, orphan drugs, stem cells, innovations in biologics manufacturing and regulatory compliance; growing issues in generic drug manufacturing and more. Amrita Patkar Event Coordinator Tel: 91-22- 4037 3617 Email: amrita_patil@jasubhai.com
Pharma Bio World
bookshelf Pharma Packaging Innovations (Paperback) Author: Sandeep Kumar Goyal Price: USD 49.00 No of Pages: 124 pages This publication comes after the success of Ideas & Opportunities 2013 held on 19th July 2013 in India. Various innovations were presented during the one day workshop by the expert consulting team of Sanex Packaging Connections Pvt Ltd popularly known as Team Packaging Connections. Idea behind this is to bring the innovations to wider group of professionals to meet the mission of packaging knowledge sharing and that too cost effectively. We feel that this publication will further fill the project pipelines of companies and improve the standards of packaging. Many professionals either do not have the access or time to go through so many innovations together. So we think this publication will fill that gap.
Tex t b o o k of P h a r m a c e u t i c a l Pa c ka g i n g Te c h n o l o g y (Paperback) Author: Kaushik Atul Price: USD 16.82 No of Pages: 472 pages The book provides the readers a thorough understanding of the packaging technology, the different types of packaging, and the importance of packaging in pharmaceutical industry. It provides a systematic and comprehensive coverage of the theory as well as the illustration of application in 19 chapters, meeting the requirements of major syllabi of packing technology in pharmacy education. It is designed to serve as a textbook for students who are studying packaging technology at both the undergraduate and the postgraduate levels, covering almost all types of packaging in industry.
Pharmaceutical Packaging Handbook (Hardcover) Author: Edward Bauer Price: USD 113.03 No of Pages: 350 pages Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods. Complete and straightforward, the book lists information in an easy to follow fashion, making it a complete standalone reference for anyone working in the pharmaceutical industry.
Pharma Bio World
March 2018 â–ş 57
ad index Sr.No
Client's Name
Page No
1
ATE Enterprises Pvt Ltd
5
2
Ami Polymer Pvt Ltd
17
3
Suresh Enterprises
15
4
Busch Vacuum India Pvt Ltd
9
5
Mack Pharmatech Pvt Ltd
19
6
Mettler Toledo India Pvt Ltd
3
7
Praj Industries
8
Technofour Electronics Pvt Ltd
7
9
West Pharmaceutical Packaging India Pvt Ltd
11
10
ChemTECH + BioPharma World Eexpo 2019
Inside Cover I & II
Back Cover
ADVERTISE TO EXPAND
your reach through
INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
For Details Contact
Jasubhai Media Pvt. Ltd.
Taj Building, 3rd Floor, 210 Dr D N Road Fort, Mumbai - 400 001 Tel: 022-4037 3636, Fax: 022-4037 3635 Email: industrialmags@jasubhai.com 58 â—„ March 2018
Pharma Bio World