Express Pharma (Vol.13, No.15) June 1-15, 2018 by Indian Express

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CONTENTS MARKET

Vol.13 No.15 June 1-15, 2018 Chairman of the Board Viveck Goenka

There is an urgent need for concerted measures and renewed commitment from pharma companies and policy makers to halt the advance of drug pollution and its disastrous impact on the environment

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

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

| P16

Senior Designer Rekha Bisht

‘A PAN-INDIA SCALE-UP WILL COMMENCE DURING THE SECOND HALF OF THE YEAR’

Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer) Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

MANAGEMENT

E- PHARMACIES: NEW RULES TO THE GAME

RESEARCH

PHARMA LIFE

MERCK’S CANCER DRUG KEYTRUDA NOTCHES ANOTHER TRIAL SUCCESS

PHARMA ALLY

RESTRUCTURING INDIAN PHARMA DISTRIBUTION MARKET TO CROSS PREDICTED $20 BN MARK OF 2020

WERUM IT SOLUTIONS TO SHOWCASE LATEST INNOVATIONS AT ACHEMA

CADILA HEALTHCARE AND SUN PHARMA RECEIVE 2018 INDIA INNOVATION CONFERENCE & AWARDS

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

BCP PARTNERS WITH MICROSOFT TO ENHANCE PRODUCTIVITY

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

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EDITOR’S NOTE

Putting all patients first

n a speech on May 12, US President Donald Trump put one of his most populist election promises — to make medicines more affordable for the US citizens — into action. Launching an initiative called American Patients First, he unveiled a list of 50 proposals. But the irony is that pharmaceutical companies who were expected to be the hardest hit, saw stock prices on an upswing post the presidential address. Analysts point out that President Trump does not seemed to have walked his talk about forcing pharma companies to lower their prices. But while US-based pharma companies like Pfizer could heave a sigh of relief, the news may not be as good for companies from outside the US. President Trump’s speech made a reference to governments that “extort unreasonably low prices from the US drugmakers” using price controls, which is being seen as a reference to countries like India who are increasing the span of price control. The US President’s speech follows the end April release of US Trade Representative’s (US TR) Special 301 report, which retained many countries, including India, on the Priority Watch List for not meeting the US’ standards of protection of the intellectual property rights of its corporate citizens. As Robert Lighthizer, US Trade Representative warned, “This report sends a clear signal to our trading partners that the protection of Americans’ intellectual property rights is a top priority of the Trump Administration.” (See detailed report:http://www.expressbpd.com/pharma/latestupdates/india-remains-on-priority-watch-list-of-ustrs2018-special-301-report/400620/) While sceptics scoff at how many larger countries would bend to such trade pressures, there is no doubt that individual companies exporting to the US will face a backlash. The pharma sector in India, especially companies like Sun Pharma, Lupin and Glenmark Pharma, which count on the US as a major source of export revenues, say that they are already operating on shrinking margins thanks to channel consolidation in the US. The faster rate of approvals is creating more competition, resulting in further price erosion. A PTI report quoted an Edelweiss research analyst estimating that the pharma sector in India will report weak Q4FY18 numbers — while revenue is likely to grow at 3 per cent y-o-y, PAT is expected to decline 9 per cent y-o-y. US revenue is expected to dip 2 per cent y-o-y in constant currency (cc), which will be the fifth consecutive quarter of decline. While President Trump’s speech did not have too many details on how these steps would be implemented, the salient points include the disclosure of the cost of medicines in TV ads, (a

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Regulators across geographies are making laudable attempts to put the patient first but will pharma companies fall in line?

clear attempt to prevent profiteering) as well as ensuring more OTC medications get approved so that patients are not dependent on prescriptions. A key expectation was that the President would use the buying (bullying?) power of Medicare to make pharma companies reduce the cost of medicines. A watered down version made its way to the President’s May 11 speech, merely referring to a reconsideration of how the scheme covering US senior citizens would pay for some high-priced drugs. The Trump administration is expected to reveal more details of how it intends to implement these proposals in the coming days. While exports to the US are expected to continue to shrink, India’s policy makers at the CDSCO, headed by the DCG(I)’s office, continue to plug gaps in the regulatory framework in the domestic market. The final minutes for the 79th Drug Technical Advisory Board (DTAB) meeting held on May 16, reveal that the Board passed important proposals that could change the way pharma companies conduct their business in the domestic market. Regulators across geographies are making laudable attempts to put the patient first but will pharma companies fall in line? For instance, one of the proposals passed by the DTAB makes companies marketing medicines responsible for the quality of the medicines, not just the manufacturers listed on the medicine pack. This is significant because most big pharma companies in India contract out the manufacturing to third party manufacturers. This provision will force them to be more diligent about their contract manufacturing facilities, as they can no longer pass on the responsibility for quality. Probably anticipating that there could be a disruption in supply of some medicines the Board clarified that persons involved in any distribution channel should not be affected and that the marketing firm should be treated as an agent of the manufacturer. Another significant proposal passed by the DTAB along the same lines was that as a test trial, the DCG(I) would ask companies to voluntarily include a trace and track mechanism on the packs of the top 300 pharma brands. For now, this is a test trial, but it gives a good indication of how serious authorities are about safeguarding the patient’s life as well as the pharma supply chain. Like in the US, industry stakeholders in India are awaiting further details on how these noble intentions will be implemented. The devil lies, as always, in the details.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘A pan-India scale-up will commence during the second half of the year’ Tarnea, is a technology company based in Bengaluru recently launched a cloud-based digital platform for pharma retail - the Tarnea SmartMile. The company claims that its solution will enable ‘brick-and-mortar’ pharmacies to become digital pharmacies. Suresh Satyamurthy, Co-founder and CEO, Tarnea Technology Solutions, informs more about this solution, the changing dynamics of the Indian pharma industry, role of digitalisation and more, in an exclusive interaction with Lakshmipriya Nair

There is a strong business case, and compelling return on investment for investment in digital technologies

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The pharma industry has been very cautious in adopting digital technology, especially in manufacturing and supply chain operations. Both the pharma industry and FMCG have striking parallels. Both are selling packaged goods to millions of customers through a complex multi-tiered supply chain and selling through lakhs of retail points. But that is where the similarities end. Most leading FMCG companies have adopted digital technologies to gain visibility into their downstream supply chain and this goes back to manufacturing also. For starters, most leading FMCG companies have invested in barcoding their products right from their factories. Like the pharma companies, they too get a lot of their products manufactured on contract from external manufacturers. But the sanctity of the barcode is strictly maintained. Pharma products as you know, seldom carry any barcodes. The pharma industry is yet to evolve the process or implement the technology

solutions for ‘track and trace’. The entire industry is extremely fragmented and there is no visibility or connect between the retailers and the pharma companies. While a lot of pharma companies have invested in tablet-based solutions for the medical representatives for detailing to doctors, they have no visibility to their own sales stocks, shipment and fulfillment. As a result, the pharma supply chain carries over 210 days of inventory, whereas the FMCG vertical operates with less than half of that. It reflects in a dramatically huge lock in of working capital of over ` 50,000 crores. There is a strong business case, and compelling return on investment for investment in digital technologies. All we now need is some concerted action. How can digital technology aid in enhancing transparency and visibility into pharma supply chain operations and help take better and faster decisions? The problems with the pharma supply chain in India are particularly acute. There has been frequent news for

product recalls and for the wide prevalence of spurious and counterfeit drugs in the market. In addition, there are frequent issues of losses due to expired drugs and the risk of these being sold to unsuspecting consumers. And very significantly, there are daily and frequent shortage of drugs at the retail counters. It is almost impossible to establish the operating conditions under which products have been stored or during transit. The common thread of all these problems is the same -- lack of visibility of information across the supply chain. In my view, there are there steps to solve the problem of visibility and transparency. ◗ Product serialisation Universally every SKU sold in the market needs to be uniquely serialised. Conceptually this is similar to the registration numbers on vehicles. Each vehicle is uniquely identified. In the western world barcoding each product is the norm. In India, it is mandatory to barcode pharma products produced for exports. But sadly it is not mandatory to do so for the domestic market. There have

been some efforts by individual companies and some retailers to implement barcodes, but these are few and far between. And certainly doesn’t solve the problem of visibility industry-wide. We live in interesting times of technology evolution. It is worth relooking the technology options beyond barcodes. There are serious alternatives like RFiD and IoT to consider. ◗ Track and trace solutions Having the products to carry a unique serial number is only a starting point. There is a need to be able to use the unique serial number or identification on the product to be able to track and trace the product wherever it might be. Such a solution will tell us not only where the

product is but also how it got there and what operating conditions it was subjected to. And, in case of a recall it gives a clear path for it to be brought back. Such a system will help the pharma companies to improve the availability and quality of the medicines, and an effective handle to deal with spurious and counterfeit drugs. It is particularly important to provide consumers with an interface to access this information to ascertain the genuineness of the product they buy. ◗ Retail automation Of the 850,000 retail pharmacies in India, a very small fraction have any automation. Therefore, even if product serialisation and track & trace solutions were to be introduced, it would fail without automation at the

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retail end of the supply chain. A small number of retail pharmacies use computers in their shops. This is used as a billing machine. They are typically built on legacy technologies and incompatible with contemporary technologies. Hence, they would fail to benefit from product serialisation and track & trace technologies. But the good news is the retail automation technology has become simple and affordable. It can be easily implemented in just a few hours. How can Tarnea bring in a new paradigm in the pharma sector? How will your solutions enhance planning accuracy, efficiency and productivity, inventory levels, and

service levels in the pharma industry? Tarnea mission is quite simply that - “Every retailer will sell like an Amazon and buy like a Walmart”. Presently, Tarnea SmartMile platform has been implemented only for the pharma industry. It changes the very paradigm of automation at a retailers’ level and connects him with both, his customers and his suppliers in realtime. It is simple and easy. Anyone can start using to sell using the platform with a 30minute training. There are customer engagement tools which pharma retailers can use to drive their own loyalty programmes and run several engagement programmes. Likewise, the platform

allows retailers to connect with and transact with their suppliers in real-time. They can share with each other the stock and delivery status. The settlement and reconciliation of their payments, receivables, tax and accounting is automatic. Even for some of the very large organisations data management is a complex and vexing problem. But for the users of the Tarnea SmartMile platform, data management is automatic. Any changes to products, product attributes, pack information, barcodes, tax rates, tax categories, drug classification etc. is handled automatically and centrally. For the first time, retailers are able to use their own data to obtain analytics and business intelligence. The platform provides easy

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MARKET to understand charts and information for retailers to run their business driven by their data. Inventory management is automatic and driven by a few key rules. Stocks are too high, the system will alert against further stock build up. Too low, it will alert the status. If it hits the re-order level, the system triggers automatic ordering. Anything due to expire, the system will help the retailer to return the stock or liquidate. Which are the major markets in the country that you plan to tap? How and by when do you plan to scale up to serve pan-India? At present, we are sharply focussed on the pharma industry. The Tarnea SmartMile platform is currently being used across AP, TS and TN. We are in the process of expanding to

It is perhaps the best possible time to drive digital transformation across large industries and pharma is right on top Western India. A pan-India scale-up will commence during the second half of the year. What are your growth strategies, in the short term and the long-term? Our growth is primarily driven through references from existing customers. That will remain unchanged in the short and mid-term. A lot of these interactions necessarily happen offline, since most pharma retailers are not reachable digitally. Over the longer term, as the digital adoption increases, we hope to reach out to our market directly and digitally.

Why is it the right time to be a digital player servicing the Indian pharma industry? We are living through three tsunamis and scarcely feel it! These are ◗ Growth and reach of Internet penetration ◗ Digital identity for citizens and businesses ◗ Success of SMEs who have already adopted new age digitally enabled business models Let me explain, at the blink of an eye, India has become the country with the second largest Internet population. Sure, usage and speeds are still not at

international standards, but the scale is continental! There are over 462 million Internet users in India now. Larger than the US, and Western Europe and only second to China. A large and growing Internet population is the base on which the government is running its own Digital India initiatives. A digital identity is as fundamental as health, water, sanitation and food. Thanks to Aadhaar, over 1.1 billion citizens in India already have a digital identity. And thanks to GST, a similar identity is getting established for businesses

too. There are already 10 million GST registered entities and still growing. Hence, we have already reached a stage where most citizens and businesses have suddenly leap-frogged to have a digital identity. In recent years, lakhs of merchants have joined online marketplaces run by Ecommerce merchants, they accept e-payments from millions of customers. SMEs running taxi services, bus services, hotel bookings etc. have seen huge adoption and successes. In my view, the foundation of a digital economy has already been laid. There are already huge transformation underway. Has anyone seen better tailwinds in the past? It is perhaps the best possible time to drive digital transformation across large industries and pharma is right on top. lakshmipriya.nair@gmail.com

PRE EVENTS

FDD CONCLAVE 2018 to be held in Hyderabad It seeks to provide a platform for formulation development scientists to gain applicable applicable insights on technologies and innovations in a rapidly evolving segment halers, dermatology, controlledrelease substances and bio-similars. With a projected moderation in R&D spends, it becomes all the more imperative that formulation and drug delivery scientists sharpen their skills and keep up to date to remain flexible to evolving market demands.

ACCORDING TO a recent report from rating agency ICRA, R&D spends of top domestic companies moderated to 8.6 per cent during 9mFY2018 but are expected to remain at 8.4-8.6 per cent. There will be a growing focus both on regulated markets and complex molecules/therapy segments such as injectables, in-

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Expanding Horizons of FDD Research: Embracing Complexity The main role of an R&D formulation and drug delivery scientist is to research, develop and optimise product formulations to fulfill the company's market strategy. However, a crucial part of this role is to ensure these formulations adhere to regulatory mandates for patient safety, efficacy and quality.

Meeting internal expectations of a differentiated product as well as fulfilling external mandates is thus the balancing act that FDD scientists have to perfect. A third factor is time. FDD scientists are often working against time, keeping in mind the competitive nature of the pharma sector. Delays could mean a loss of market share while poor quality could mean batch recalls and loss of reputation. Which is why the Indian Express (P) Ltd and Express Pharma, India's leading Pharma Business Magazine, launched the Formulation and Drug Delivery Conclave (FDD Conclave) in June 2017, with the message: Staying Ahead of the Curve. FDD Conclave 2017 had

insightful sessions on Ensuring Successful Development of Complex Generics, regulatory perspective of Lipids as Excipients in Pharmaceutical Formulations, Advances in Film Coating Technology, Dry Enteric Coatings as a Superior Polymer Technology to Meet Emerging Drug Delivery Demands, and panel discussions touching pertinent issues like FDD strategies to increase compliance in special population segments, and the need to expand India's FDD talent pool. FDD, in its second edition, will take a deeper dive into evolving regulations which are fundamental to the FDD scientist's role one of the key gatekeepers of a company's future reputation and market leadership.

Some proposed topics: ◗ Product Development Through Integrated Project Management ◗ 505(b)2: Avenues for Development ◗ Regulatory Pathways for Specialty Generics ◗ Impact of Brexit on EU submissions ◗ The Potential of Specialised Injectables ◗ Advances in Powder Processing Technologies Contact Rajesh Bhatkal T: 09821313917 Email: rajesh.bhatkal@ expressindia.com Vinita Hasija T: 09820590053 vinita.hassija@ expressindia.com

MARKET

analytica Anacon India and India Lab Expo to be held in Hyderabad The event to be held from September 6-8, 2018, will have the potential for more than 259 exhibitors and 7714 visitors analytica Anacon India and India Lab Expo are Indiaâ&#x20AC;&#x2122;s largest and most important platform for the analysis, laboratory-technology and biotechnology market. They have the potential for more than 259 exhibitors and more than 7,714 visitors in three halls. The event will be held in Hyderabad from September 6-8, 2018. The event will focus on innovative and applied product and system solutions for laboratories in the indus-

The conference is tailored to the Indian market, which will give profound insights into science and research. International experts will present the latest techniques in all sectors trial, research and science sectors. As the industryâ&#x20AC;&#x2122;s definitive forum, fair and conference gather all relevant information about the latest

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developments. Both events will cover the entire value chain for industrial and research laboratories. The focussed exhibition

sectors will give visitors a comprehensive overview of the market, innovations and best-practice examples: analysis, biotechnology, labo-

ratory technology, quality control, measuring and testing. The conference is tailored to the Indian market, so it will give profound insights into science and research. It is where international experts present the latest techniques in all application sectors. International market leaders as well as local Indian manufacturers will participate in the trade shows. EP News Bureau

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MARKET POST EVENT

IPGAfelicitates Dilip Sanghvi,MD,Sun Pharma Sanghvi has been elected as the President of 70th IPC; the Congress will be held in Noida from December 21 to 23, 2018 Usha Sharma THE LOCAL Organising Committee of the 70th Indian Pharmaceutical Congress (IPC) recently felicitated Dilip Sanghvi, Managing Director, Sun Pharma in New Delhi. Sanghvi was elected as the President of 70th IPC. The theme for this year’s Congress is ‘Pharma Vision 2030: Indian Pharma Industry, a Global Leader,’ which will be held at Amity University Noida from December 21-23, 2018. Indian Pharmacy Graduates’ Associations (IPGA) will host 70th IPC and Delhi will host the Congress for the ninth time. Speaking about the felicitation, Sanghvi appreciated the efforts of the Indian pharma industry in creating their own niche in the global pharma space. In his speech, Sanghvi mentioned, “We (Indian pharma industry) have become an important generic supplier to the global market.” More than 50 per cent of the drugs sold in the global markets have links to the Indian pharma industry. Sanghvi also emphasised the need of skill-based talent requirement to migrate from generic-based approach to innovative drugs. He mentioned that only through skill enhancement, the sector will be able to grow significantly. He also stressed on reverse engineering in pharma sector and create more value to existing system. Congratulating Indian pharmacists, Sanghvi said that the success of the Indian pharma industry is largely due to fellow pharmacists and their contribution have added significant values. He said, “I am looking forward to 70th IPC.” BR Sikri, LoC Chairman, 70th IPC, Atul Kumar Nasa, Head of Office/ Controlling Authority Drugs Control Depart-

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ment, Government of NCT, Delhi, RC Juneja, Chairman, Mankind Pharma, Dr S Eswara Reddy, Drugs Controller General (India), Dr Surinder Singh, Director, National Institute of Biologicals, VG Somani, Central Drugs Standard Control Organization, TV Narayana, President, Indian Pharmaceutical Association, Sudhansh Pant, Joint Secretary, Ministry of Chemicals and Fertilisers, Department of Pharmaceuticals, Government of India, were present on the dias to felicitate Sanghvi. The LOC also congratulated efforts of regulators, different

Indian Pharmacy Graduates’ Associations (IPGA) will host 70th IPC and Delhi will host the Congress for the ninth time associations and academics and to recognise them felicitated key contributors from each segments. Nasa presented the token of gratitude and spoke about the success the Congress. In his vote of thanks, Sikri spoke about moral supports which they have received from industry stalwarts. He said that this year’s Congress will not only be a success but will create a platform for the younger generation within the Indian pharma industry. u.sharma@expressindia.com

MARKET EVENT BRIEFS FDD CONCLAVE 2018 Date: June 15-16, 2018 Venue: Novotel Airport, Hyderabad Summary: Organised the Indian Express (P) Ltd and Express Pharma, India's leading Pharma Business Magazine, Formulation and Drug Delivery (FDD) Conclave is the platform to learn about new technologies, innovations and applicable insights in a rapidly evolving segment. In its second edition, it takes a deeper dive into evolving regulations which are fundamental to the FDD scientistsâ&#x20AC;&#x2122; role as one of the key gatekeepers of a companyâ&#x20AC;&#x2122;s future reputation and market leadership. Contact Rajesh Bhatkal T: 09821313917 Email: rajesh.bhatkal@ expressindia.com Vinita Hasija T: 09820590053 vinita.hassija@expressindia.com

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

Contact Catherine Jones Program Manager Pharma Conference 2018 47 Churchfield Road, London, W3 6AY, United Kingdom

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

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

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

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GULF CONGRESS ON PHARMACYAND PHARMACEUTICAL SCIENCES Date: September 17-18, 2018 Venue: Abu Dhabi, UAE Summary: The theme of the conference is Global Innovations & Recent Advancements in Pharmaceutical Science. Pharma Conference 2018, an international event, will focus on the core knowledge and major advances in the ever-expanding field of pharmacy and pharma sciences.

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There is an urgent need for concerted measures and renewed commitment from pharma companies and policy makers to halt the advance of drug pollution and its disastrous impact on the environment

By Lakshmipriya Nair

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ndia is the global host for 2018 World Environment Day, to be observed on June 5, as part of the UN’s endeavour to spread awareness and draw attention towards pressing environmental concerns. As part of this year’s theme, ‘Beat plastic pollution’, India joins global leaders in tackling the huge menace of plastic waste and seeking solutions to this mammoth challenge. But, even as we train our focus towards this pertinent issue, it’s time we recognised and addressed another environmental concern of the same magnitude - drug pollution. Yes, ironically, the pharma industry, entrusted with the role of saving and improving lives, is allegedly one of the major contributors to environmental pollution. And, the Indian pharma industry, often called the ‘Pharmacy of the World’ has been named as a chief perpetrator of this transgression.

Drugging the environment It has been accused that in the march towards fulfilling its ambitions of becoming a global pharma powerhouse, India’s pharma sector is responsible for fuelling the creation of an environmental crisis with its poor wastewater management and effluent treatment methods as well as negligence in monitoring and reducing levels of greenhouse gas emissions. Several global studies highlight and caution against the rising drug pollution in India. (See BOX: Drug Pollution: A mammoth issue) Drug manufacturers deny these allegations, refute the findings of the reports and attribute vested interests to the global organisations who have funded these reports. But, India’s Environment Ministry itself classifies pharma manufacturing as a “red category” activity due to the production of hazardous waste.

Getting to green Pharma companies are morally bound to develop effective alternatives to products and processes which might be harmful to the environment in a bid to

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tackle the crisis of drug pollution. It has become imperative for the industry to look at adopting more sustainable drug discovery routes and development practices. But, how should the industry

go about achieving this objective? Renowned pharma scientist, Dr Himadri Sen, Chairman, STEERLIFE India recommends that going green is possible through designing of pharma

THE MAIN FOCUS

products and processes which prevent or reduce the use and generation of hazardous substances. He also opines that continuous manufacturing provides cleaner, flexible, efficient options of running pharma

processes through implementation of PAT and thereby reduces carbon footprint. Avoiding the use of Class I and II solvents in both, API manufacturing and pharma product manufacturing;

cover ) recycling of other solvents etc. are some of the other measures that he recommends to improve the environmental credentials of pharma companies. Similarly, Dr Sajeev Chandran, Associate Director, Advanced Drug Delivery Research & IVIVC/Biopharmaceutics, Pharmaceutical R&D, Lupin, refers to the adoption of ‘benign syntheses as an environment-friendly measure. He clarifies that it may mean using less of organic solvents (methanol, dichloromethane, toluene, dimethyl formamide and acetonitrile), using less hazardous reagents, decreasing number of steps in the synthesis process of the molecule and also developing bio-friendly catalysts.” Dr Rakeshwar Bandichhor, Associate Director, API, R&D, Dr Reddy’s Laboratories apprises, “A myriad of opportunities are there with the generic industries to reduce the E-factor and develop cost effective and green synthetic routes of medicines.” He says, “Given the opportunity, the philosophy of green chemistry, which is best defined as the utilisation of a set of principles that reduces or eliminates the use or generation of hazardous substances in the design, manufacture, and applications of chemical products, can be adopted. He explains, “Staying with green chemistry fundamentals,

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DRUG POLLUTION: A MAMMOTH ISSUE

he findings of a major study undertaken in 2016 by Changing Markets Foundation, a non-profit organisation, on behalf of Nordea Bank, a Sweden-based financial institution highlighted that Hyderabad is facing uncontrolled pollution due to the toxic waste generated from the city’s drug manufacturing facilities. The city is home to several major pharma players including Aurobindo Pharma, Hetero Drugs, Dr Reddy’s Laboratories, Mylan, and MSN Laboratories, amongst others; and is one of the world’s largest bulk drug manufacturing hubs, exporting a huge amount of medicines to markets across the globe, including the European Union and United States every year. What’s more, a follow-up investigation titled, ‘Hyderabad’s pharmaceutical pollution crisis: Heavy metal and solvent contamination at factories in a major Indian drug manufacturing hub’, which included field tests conducted in April and September 2017, claims that the measures taken to control pollution have not had the desired effect. In fact, the report cautions, “with plans afoot to expand the city’s pharma production capacity over the coming years and the lack of credible regulation and measures to control manufacturing emissions, the future looks grim for the area’s inhabitants.” A report published in the Journal of the Geological Society of India in October 2017 also revealed that groundwater in Hyderabad’s Nalgonda district contain toxic substances including lead, cadmium, vanadium and arsenic “in concentrations that are thousands of times higher than the maximum levels prescribed for drinking water quality by the World Health Organisation (WHO) and Bureau of Indian Standards (BIS).” It also discloses that the adverse impact of this pollution on human health and ecosystems include near eradication of some species, feminisation of fish and rise in antimicrobial resistance (AMR).

right route selection/processes amenable to scale up with minimum PMI etc. would make pharma products less burdensome environmentally. For more than a decade, we have witnessed a lot of technological advancements and sophisticated tools are now available to realise green chemistry and engineering at higher scale e.g. continuous manufacturing, bio-catalysis etc. These enablers have the potential to make medicines without adversely affecting the environment.” So, what has been the progress on this front? Are many drug companies making conscious efforts towards inculcating more environmentfriendly practices in their drug development processes? These questions elicit a mixed response from the industry experts and veterans. Dr Bandichhor explains, “Over the past few years, the importance of green chemistry gained momentum and significant amount of research have been directed towards the development of new technologies and methodologies for environmentally benign processes at the innovator companies. Apart from technological green paradigm shift, improvements in the process conditions, economics, ever-increasing environmental controls and social pressure, incorporating green chemistry into the syntheses of medicines

( and intermediates have been steadily gaining priority in the pharma industry.” However, he also points out, “Consideration of green principles into synthetic route design has evolved into an institutionalised practice among major pharma companies, but still has a long way to go.” Dr Sen feels that though Indian pharma companies are familiar with these concepts, a sincere effort to implement them is lacking due to limited availability of options, regulatory framework and lack of financial rewards. Cecilia Van Cauwenberghe, Associate Fellow and Senior Industry Analyst, TechVision and Vandana Iyer, Senior Research Analyst, TechVision, Frost & Sullivan informs, “There is a growing awareness about sustainable drug discovery and development methods across the global pharma industry, as evidenced by the shift towards the adoption of green chemistry practices by large pharma concerns such as Abbott, Amgen, Merck, Roche and Johnson & Johnson.”

Barriers to sustainability Experts endorse the adoption of greener products and processes, but also make us aware that making the shift from the current practices to more sustainable approaches such as adoption of green chemistry would be no child’s play. Van Cauwenberghe and Iyer explain, “Drug discovery and development is in itself a challenging and time-consuming process which is associated with high attrition rates. Hence, redesigning an established process using a more sustainable approach is usually perceived as a difficult process from a business and technological standpoint. Most chemists would face challenges in incorporating green practices throughout the drug discovery and development process.” Nitesh H Mehta, Co-Founder Director, Newreka Green-Synth Technologies and Krishna B Padia, Executive Director, Green ChemisTree Foundation, in an earlier article shared with Ex-

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press Pharma, had listed down and elaborated on the myriad that impede the implementation of green chemistry. Here are some excerpts from that article. ◗ Lack of availability of green chemistry-based technologies:

The green chemistry tool box (set of platform technologies based on the principles of green chemistry and engineering, alternatives to conventional synthetic chemistry-based processes/chemistries) is still

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quite empty. We still don’t have viable green chemistry-based solutions for many processes like nitration, sulphonation, friedelcraft, etc. ◗ Challenges in scale-up and commercialisation of green

chemistry-based technologies: There are many inventions/ innovations that have already been developed by various academic and research institutes and these are potential solutions for some of the environmental

cover ) challenges faced by the industry. However, for whatever reasons, these solutions haven’t been pursued after lab scale development. Academic/research institutes need to make extra effort to customise the solutions and demonstrate their technical and commercial viability at a reasonable scale, to gain the industry’s confidence. The industry needs to stretch themselves to take the risks that are associated with scale-up and commercialisation of new solutions. ◗ Lack of connect between green chemistry solution providers to industry: One of the key barriers is the communication gap between the industry and green chemistry solution providers. This could be because the industry is in one part of the world and the solution providers is in other part of the world. This could also be due to insufficient marketing of the potential solution by the solution provider (usually the case with academic/research institutes who don’t proactively market their solutions to the industry). This could also be due to industry not putting enough efforts to search and look around for solutions. ◗ Lack of knowledge and information about green chemistry: Chemists and chemical engineers working on designing new products and processes have limited knowledge about the basic principles of green chemistry and engineering. It’s critical to ensure that teams working on drug discovery and development have workable knowledge about these principles. It’s also important to introduce green chemistry in our curriculum so that the next generation of chemists and chemical engineers are shaped to think ‘green.’ ◗ Myths about green chemistry: Certain myths prevailing about green chemistry are also a barrier in its implementation in the industry. Myths like green chemistry is good theory but not practically feasible, it is difficult and complex, not viable for small

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nterestingly, drug pollution is a long identified problem. In fact, Parcelsus, a renowned Swiss physician and alchemist of the 16th century, credited with the introduction of chemistry in medicine, had cautioned that ‘the dose makes the poison’. As one of the basic tenets of toxicology, it means ‘a substance can produce

and medium size organisations, it requires huge resources, etc., should be busted. ◗ Regulatory barriers: In pharma and other industries, any change in processes (when a green chemistry-based process is replacing a conventional process), has to go through validation trials, changes in documentations and filings, as well as require series of approvals from

harmful effect associated with its toxic properties if it reaches a susceptible biological system within the body in a high enough concentration.’ (Source: Wikipedia). This adage also provides the basis for public health standards and highlights the need to ensure that only acceptable levels of contaminants are found in food, drinking water and the environment. It can said that negligence in understanding the gravity and significance of these teachings and taking effective measures to put them into practice have led to today’s crisis of drug pollution and its magnitude.

internal regulatory affairs team, customers and finally, from external regulatory agencies like FDA. Besides the time invested for tedious process of making these changes in DMF filings, this also involves significant cost/ financial resources. Hence, green chemistry-based solutions need to offer returns that justify the investment of time and money.

Ways to catalyse progress It is said that for every problem there is a solution. It stands true in this case as well. Industry experts inform that though it would require strategic planning, concerted efforts and long term commitment, there are ways and means to encourage greener practices. Let’s examine some of the major ones. ◗ Building a business case for

going green: Van Cauwenberghe and Iyer expound, “Focusing on green chemistry practices that improve the efficiency of drug development methods will help derive more value through lower material consumption. Using fewer materials for drug synthesis can help reduce waste and production costs and can help improve the total yield of the product. This will surely aid in making a very strong business case for green drugs.” Dr Bandichhor points that there is a strong business case for greener products in pharma. “Since cost effective, green chemistry which is involved in production of medicines does not allow generation of significant amount of waste and reduces environmental burden, it can fetch more profit than the regular products because of two reasons: In-built cost effectiveness and products can be marketed at a higher price with special emphasis in the leaflet information that the product has been developed by using green technologies,” he elaborates. ◗ Incentivising green practices: Van Cauwenberghe and Iyer recommend this and say, “It will help drive new innovations in pharma production methods, while also promoting awareness about sustainable drug discovery and development pathways. Lastly, it will be extremely important for organisations to have a transparent and unbiased reporting structure for encouraging green drug discovery practices at every stage of development. This will help enable optimal outreach and support for creating sustainable pharma solutions.” ◗ Regulatory support: Dr Sen recommends, “The government and regulatory authorities should encourage pharma industries to develop product and process which are energy efficient, less toxic to the environment and use recyclable solvents and packing materials. The government should provide tax benefits and extend exclusivity. The regulatory agencies should consider facilitated reviews for the implementation of

(

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green and efficient process and products. It should also ban or tighten the limit for materials which has potential environmental hazards. Dr Bandichhor recommends, “Quality products, those are being developed using green technologies, can be approved at a faster pace by regulatory agencies and sold at a higher price due to the fact that the development requires intensive R&D toward simplification or finding complicated chemistry/process alternatives.” Agreeing with these views, Dr Chandran apprises that governments and regulatory agencies in the US, EU and Japan have been very aggressively encouraging and incentivising pharma industry to adopt greener practices. Citing an example, he says, “In 1995, the US Environmental Protection Agency (EPA) instituted an annual awards programme, highlighting scientific innovations in academia and industry that advanced green chemistry. This was under the patronage of the President of USA. Many states in the US now have legislative restrictions on using toxic solvents/chemicals in synthesis of pharma and household goods.” He also informs that in 2005, three scientists – Yves Chauvin of France, and Robert Grubbs and Richard Schrock of the US – won the Nobel Prize in chemistry for simplifying the process of synthesising carbon compounds. India too should look at encouraging individuals and organisations involved in researching, developing and implementing green solutions. ◗ Industry-academia collaboration to encourage green chemistry: Van Cauwenberghe and Iyer say, “However, they feel that there is still a rising need for improving the dialogue between the industry and academia for encouraging the adoption of greener approaches for drug discovery and development applications.” “Industry and academic experts should be willing to support green chemistry approaches by providing the appropriate academic and laboratory environment as needed, even if it requires greater time and investment,” they say further. They further opine, “Academic initiatives that engage closely with industrial establishments will help address green chemistry challenges effectively, while also enabling the increased adoption of sustainable drug development practices. Initiatives such as the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable should be encour-

aged and nurtured to help drive green pharma innovations and set global standards for sustainable pharma practices.” Dr Bandichhor also highlights, “Lack of education at fundamental level has posed a great challenge toward mandating and implementing green chemistry in general.” He further informs, “In the recent past, both industry and academia have started playing a pivotal role in invigorating green chemistry and engineering to have processes which are more sustainable and robust. But, the bigger challenge that we have today is to bring green chemistry to a level where it becomes an unavoidable and obvious choice during product development. Collaborative green education must start from the academic course that can teach us about significance of green approaches in pharma material production.” Thus, there are various steps that can be taken if there is serious commitment towards the environment.

Benign by Design: The panacea to our problem? ‘Benign by Design’ is another interesting concept that comes to fore as we look for more sustainable approaches. Over the past few years, this term has gained a lot of traction. In the context of the pharma industry, it is often used to refer to drugs which are intentionally designed to be eco-friendly as they are easily biodegradable in the environment. Explaining the concept further, Dr Chandran elaborates, “Benign by design involves molecules being designed in such a way that it only survives as long as it is required to provide its necessary function and not beyond. And thereby preventing long-lasting drug molecules that leave our bodies undigested (metabolised) or unchanged, and escape into the environment. The proponents of green chemistry call it ‘Holy Grail’ of drug design: triggered instability. It means that we should be able to find a method to stabilise a compound when we want it and destabilise it when the intended purpose is over.” He further informs, “It is known that almost 15-20 per cent of commercially available drugs are already bio-degradable but by chance so in a sense can be considered ‘green drugs’. The question is, can it be done intentionally?” Globally, there are a few proponents of this concept. For instance, Klaus Kümmerer, Environmental Chemist from Leuphana University in Lüneburg, Germany and John Warner, Co-founder,

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cover ) Warner Babcock Institute for Green Chemistry in Wilmington, US are researchers pursuing strategies to develop biodegradable drugs. They have met with a limited amount of success as well. But, the current belief that stable compounds are the best, when it comes to ensuring efficacy and effectiveness of drugs, is one major impediment to the adoption of concept. However, its advocates claim that “making compounds stable under all circumstances is the wrong goal.”(https://www.chemistryworld.com/earth/environmentally-benign-by-design/ 3007842.article) Dr Chandran also enlightens, “Greener pharma formulations which use excipients to stabilise the drug till the intended purpose of use can be designed. In today’s approved drugs list, there are many examples wherein drugs are stabilised by way of physical or hydrogen bonding with excipients. More companies are starting to see the business opportunity in intentionally designing drugs that disintegrate harmlessly in the environment. Such companies want to be prepared if more consumers ask for better drugs without unwanted side effects.” But he believes that one of the biggest challenges in its way would be getting regulators on-board. He says, “There has to be a fundamental shift in the industry perspective as to how we perceive stability of a drug molecule. Another important initiative will be introduction of this concept in mainstream university curriculum.” But, do we have any takers for it in India? There is a lack of clarity on this front. As Dr Chandran explains, “Not many Indian companies as on date are involved in NCE research and till now, no entirely new molecule has been approved out of their research programs. So, it is difficult to comment how much of this design concept has been implemented at their end.” However, as the old adage goes, ‘Where there’s will, there’s a

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CASE STUDIES: GOING GREEN Case 1: Amgen moved to using enzymes instead of transition metals for catalysing small molecule synthesis. This helped reduce the manufacturing time by 80 per cent. The process change also doubled the yield, lowered the cost of starting material by over 99 per cent and eliminated the need for organic solvents used in chromatographic small molecule purification. Case 2: Researchers at North Carolina State University developed a green chemistry method that improves pharma manufacturing efficiency, while minimising the cost of processing time. The development consists of a microsphere-packed, tubular reactor which is used in a pseudo-homogeneous catalysis technique. The elastic siliconebased microspheres were developed using a microfluidic technique and are loaded with palladium catalyst. This microfluidic system generates elastomeric microspheres with a narrow size distribution to make them suitable for loading in a tubular reactor without clogging. Apart from providing enhanced efficiency, this pseudo-homogeneous technique encourages a green approach by using nontoxic solvents such as water and ethanol.

way’. And, as India ventures on a journey of innovation, if it takes strategic measures and invest time, resources and money in adopting the concept of ‘benign by design’, the country could negate allegations against it of polluting the environment and emerge as a true global power house through sustainable approaches.

What does the future hold? Drug pollution has huge adverse impact and implications to our survival itself. We are on the brink of a huge existential crisis, spawned and spurred by our negligence and misuse of our ecological resources. Therefore, it is time to realise that we will soon be staring our own extinction in the face unless unless initiate strong measures to reverse the harm done to the environment. It is time for the Indian pharma industry to find ways of healing the patients without harming the environment, to safeguard our future.

References

Case 3: When Pfizer was gearing up for commercial production of Viagra (sildenafil citrate), their chemists designed a new reaction strategy that radically reduced the amount of solvent required, cut out the reagents tin chloride (an environmental pollutant) and hydrogen peroxide (a fire and transportation hazard), and produced just a quarter of the waste of the original process. Case 4: Another leading drug for treating high cholesterol, Zocor (simvastatin), traditionally used a multistep method involving large amounts of hazardous reagents that produced a large amount of toxic waste. A new method for synthesizing the drug uses an engineered enzyme and a low-cost feedstock that was optimised by Codexis, a biocatalysis company Case 5: Codexis again collaborated with Merck to develop a greener route for synthesizing sitagliptin, the active ingredient in Januvia, a treatment for type 2 diabetes. This collaboration led to an enzymatic process that reduces waste, improves yield and safety, and eliminates the need for a metal catalyst Case 6: STEERLife has developed a continuous wet granulation process using Twin screw processing technology. This single step process perform Granulation, drying and sizing in a single pot thereby improves the processing efficiency and is a much cleaner process. STEERLife has collaborated with Prof. Muzzio Fernando, Rutgers University, US. Under C-SOPS programme to develop a true continuous process for tablet manufacturing.

- Dunn, P.J, Galvin, S. and Hettenbach, K. “The development of an environmentally benign synthesis of sildenafil citrate (Viagra™) and its assessment by Green Chemistry metrics.” Green Chem. 2004, 6, 43-48. DOI: 10.1039/B312329D - U.S. Environmental Protection Agency. “Presidential Green Chemistry Challenge Awards: 1997 Greener Synthetic Pathways Award.” http://www2.epa.gov/green-chemistry/1997-greener-synthetic-pathwaysaward (accessed June 30, 2015). - U.S. Environmental Protection Agency. “Presidential Green Chemistry Challenge Awards: 2012 Greener Synthetic Pathways Award.” http://www2.epa.gov/green-chemistry/2012- greener-synthetic-pathways-award (accessed June 30, 2015). - U.S. Environmental Protection Agency. “Presidential Green Chemistry Challenge Awards: 2010 Greener Reaction Conditions Award.” http://www2.epa.gov/green-chemistry/2010-greener-reaction-conditionsaward (accessed June 30, 2015). - Leahy, D. K. et al. Org. Process Res. Dev. 17, 1099–1109 (2013) -https://doi.org/10.1002 /aic.16119 lakshmipriya.nair@expressindia.com

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E- pharmacies: New rules to the game The government recently released draft rules to regulate e-pharmacies and their activities. The industry lauds certain measures such as the ones to restrict data sharing and protect patient privacy, it also raises a few pertinent concerns such as no capping on discounts. Many also feel the need for more clarity to understand the implications and impact of the guidelines better BY USHA SHARMA

Curb on discounts will give a level playing field Sripal Bachawat,Director,C-Square Info Solutions

he draft rule is a great move by government to regulate e-pharmacy. It will put some licensing and inspection mechanism in place. This rule now allows anyone to create an e-pharmacy and give additional convenience to general public. It will enable pharmacy business in a more ethical way. Currently, medicines are dispensed even without prescription but in this case, we need to have a complete track mechanism in place till it reaches the patient’s doorstep. E-pharmacy, being a tech product, will ensure that patients are reminded of their dosage timings.

But, a major part of the worry is that e-pharmacy is a capital intensive activity and therefore existing mom-n-pop stores cannot think of participating in this new wave. The rule does not even allow them to work with anyone like other trades which have the privilege of working with Flipkart and Amazon. This puts a question mark on mom-n-pop stores’ future. The ideal situation would have been allowing a marketplace which can be setup by area level retailers for their consumers. Another important fact is burn in other, non-pharma businesses are ok because the re-

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tailer is part of demand creation and hence they can demand a better margin. The pharma supply chain, being just a demand fulfiller, has limited access to additional margins and

hence it becomes very difficult for mom-n-pop stores to compete with these burn start-ups. There should have been some rule on discounts to protect the interest of the trade. Otherwise, in the name of survival, mom-npop stores will engage in trading sub-standard drugs which comes with higher margins and that’s bad for consumers. We faced a similar situation, when companies started luring doctors with freebies and they started writing medicines which were not required for patients. A curb on that has generated high benefits for the general public. Similarly, a curb on discounts by e-pharmacies will give mom-n-

pop stores a level playing field. We, C-square, as a tech provider invest huge time and money and work hard to give tech solutions to both, full fledged e-pharmacy companies and stand-alone retailers with complete back end solution. Full fledged companies have deep pockets to invest in complete tech stack but small retailers do not have the capital to invest in these large volumes. The only solution is a common platform for all players but the new rule doesn’t provide any room for the same. We currently have the capability to provide solutions to any type of epharmacy.

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MANAGEMENT

‘Draft rules do not elaborate on last mile delivery and associated complications’

‘The most recent draft is fair and balanced’

Sameer Sah,Associate Partner,Khaitan & Co

Pradeep Dadha,Founder & CEO, Netmeds Marketplace

he draft rules are overall a positive move as now there will be some framework available specifically addressing this business model – what will or will not be allowed is a matter of regulation and will no doubt evolve from time to time. The model covered in the draft rules appears to be one that is more in the nature of a market place as opposed to an actual sales website as the dispensation has to eventually be done from a licensed premises – while the same company could have both a physical and virtual presence, but for scale it is bound to rely on more third party chemists and locations. What is worrisome is that the marketplace would be responsi-

ble for legal compliances of the eventual dispenser. One will need to see the final rules to gauge a better understanding. The draft rules indicate that data from e-pharmacies is not to be shared with anyone except

the Central Government for public health purposes. This eliminates possibilities of these companies monetising this data – and one also wonders how IMS or other agencies will gather pricing and sales data from the e-pharmacies. The medicines have to be provided against prescriptions – this will definitely address selfmedication on prescription drugs – but one wonders whether this will also affect OTC sales. The draft rules do not elaborate on last mile delivery and associated complications as that forms a core part of the overall business – that is an obvious miss – along with it arise things such as endorsing the prescription, etc.

‘I would like to have more clarity’ Hemant Kumar Bhardwaj,Co-founder,MD & CEO, PM Health & Life Care (Zigy.com)

t's great to see that finally draft rules with regards to e-pharmacies. I appreciate the fact that regulators have ensured prescription adherence because any substitution by a retailer is highly risky as greed may come into play. I also appreciate that it will be the central licensing authority that will grant the licenses to e-pharmacies. Assuming that given license will allow an e-pharmacy to operate on pan-India basis, will the license of e-pharmacy e suspended or cancelled because of non-compliance in one of the cities, will it impact its operation across the country? I would like to have more clarity on how things will

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work in a marketplace model, where e-pharmacies will have partnerships with local retailers for the supply of medicines. In a scenario where local retail partner defaults on compliance while

fulfilling the e-pharmacy's orders, will e-pharmacy too get penalised? The draft takes serious note of delivery of medicines by e-pharmacies, especially for medicines which require cold chain. For such medicines, intercity couriering should be strictly prohibited. Even within the city, these medicines should be delivered inpacks/boxes so that they don't lose their efficacy when they reach the customers. It should be mandatory for e-pharmacies to have a mechanism in place to ensure that the medicines are delivered only after verifying that the physical copy of the doctor's prescription at the doorstep of the customer.

e recently had an opportunity to review and digest the proposed amendments to Drug and Cosmetic Act of 1945 as prepared by the Drugs Technical Advisory Board (DTAB). The new rules, known as the D&C A 2017, appear to be fair and balanced, as well they should be, having been drafted after much research and analysis and are based on inputs from industry experts from both the public and private sectors and seem well designed to accomplish the objectives. Stakeholders from all sides of the equation had an opportunity to voice their opinions about the many important issues addressed in this rewrite of rules that had not been revisited in almost 90 years. One of the over-arching goals was to fulfil the promise of PM Modi’s vision of a ‘digital India’ as it applies to healthcare, and its apparent that the most recent draft is fair, balanced and will help meet those goals. One important aspect of the rules is 67K/M which addresses ‘data sharing’ and patient’s right to privacy, which becomes ever more important, as millions of prescriptions are collected and and large databases are amassed. Rules are only as good as the intent and ability of the stakeholders to follow them, and Netmeds has always been dedicated to the principle of absolute date security and privacy and it has demonstrated over the course of its three years in existence, that it strictly adheres to ‘zero tolerance’ of data disclosure, as it pertains to the personal de-

tails of its customers. However, it must be noted that there is a difference between sharing "personal data" as it pertains to the individual’s medicine consumption, and ‘anonymous’ data exchange, as it pertains to usage, i.e., prescriptions written linked to batch numbers, etc. So we think that the language is appropriate and useful and protects the patients right to privacy, while still allowing for and important and useful exchange of data between, regulators, manufacturers and retailers. In summation, we feel that everyone who had an opportunity to offer inputs, raise objections and otherwise participate in the draft process has been heard, understood and represented. We look forward to a final ratification and adoption of the new rules, and we are confident that they will give the new industry strong guidelines to follow, and that the end result will be better health outcomes for the citizens of India. u.sharma@expressindia.com

MANAGEMENT

Restructuring Indian pharma distribution market The current pharma distribution market in India is in a completely erratic state. Dr Piyush Gupta, Associate Director - GNH India, gives an insight on the need for rules and regulations that should be levied on the distribution chain to trace back the exports or provide control to them INDIA ENJOYS an important position in the global pharmaceuticals sector. The Indian pharmaceutical sector is estimated to account for 3.1 – 3.6 per cent of the global pharma industry in value terms and 10 per cent in volume terms. With the Indian generics accounting for 20 per cent of global exports in terms of volume, India stands as the largest provider of generic drugs at the global level. According to Pharmexcil, India’s pharma exports grew 2.91 per cent to $17.27 billion in 2017-18 which stands as a potential indicator of India reaching $20 billion by the year 2020. The various factors that contribute to this achievement are the holistic supply chain, the effective logistics involved in exporting to other countries, etc. However, the country still faces some challenges and hardships which, if worked on, shall let India cross the $20 billion mark and reach a higher estimate than predicted. The current pharma distribution market in India is in a completely erratic state. There is an absence of rules and regulations that should be levied on the distribution chain to trace back the exports or provide control to them. Illegitimate storage protocols and the ambiguity in temperature controls stand in the idea of bringing about a systematic and standardised distribution process. The various forms of medicines are to be transported and stored at different environmental conditions, e.g. tablets need separate storage and temperature levels as compared to syrups. Hence, all medicines cannot be handled with one general rule. We have heard of incidents wherein medicines have been exported in polythene bags which show the level of disori-

entation and lack of proficiency present in the Indian pharma market. Loss of sales due to nonavailability of products at the retailer’s end is a reality in the current pharma distribution setup. According to a study, the volume sales loss ranges to five per cent in OTX brands primarily in tier 2 and rural areas which comprises 70 per cent of the country’s population. The inability in uprooting this problem can lead to a revenue loss of 30per cent to 50 per cent which will be a big blow to the pharma market. The distribution channels need to undergo certain amendments in order to metamorphose into a structured sector. If distribution is regularised, leakages can be prevented. Reduction and thereafter eradication of leakage will lead to enhancing the quality of distribution. The pharma exports of India lack authority and responsibility. E.g. if a factory ships a consignment of 100 and the pharmacy receives one with 99, the damage is not recorded. There is no explanation/ investigation done for the shortage in the quantity of the shipment. Freight Watch International sees it as a serious problem in Brazil, Great Britain, India, Mexico, Russia, and South Africa. Indeed, cargo security is generally more of a problem in low- and middle-income countries, where poor roads and slow transit times put shipments at risk for a long time, and in politically volatile places. Criminals take advantage of such places where the distribution chain breaks down and medicines depart from documented chain of custody. Drugs that leave the proper distribution system are called diverted drugs. Drug diversion is the means through

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Dr Piyush Gupta, Associate Director - GNH India

which medicines approved for sale in one country are sold in others, where they may not be registered. These schemes depend on false statements, forged customs declarations, or smuggling. This also gives aid to producing counterfeit drugs. Counterfeit drugs occur due to weak supply chains and pose a challenge in front of the pharmaceutical industry. They appear everywhere but most seriously affected is Africa, especially with antimalarial medication, but the legitimate supply chains in developing and industrialised countries are also compromised. Annihilation of these drugs will allow the flow of genuine and effective medicines, retaining the caliber of exports. Managing the drug distribution system in developing countries includes undertakings like containing the costs of the last mile, moving medicines to patients quickly, and keeping records of all transactions between the manufacturer and the consumer which brings us to the other obstacle that lies in our path of reaching the goal is the administration system of India. We still

live in the traditional age old order where many things in the country are paper based. We have come a long way in technology; however, our administration still proves to be a deterrent. It takes years for us companies to clear permissions. Unsafe storage i.e. poor warehousing is another factor that leads to the deterioration of the quality of the medicines and in turn, disrupts the cycle of distribution providing inconvenience to the manufacturer. If any chemical loses its efficacy, it turns useless and the manufacturer is put to blame. For e.g. if a can of soda is damaged or not supervised and is left open for long, it loses its fizz. This leads to ruining the quality of the product and the consumers then blame the manufacturer for the delivery of deteriorated goods. Thus, significant amount of wastage can be prevented by undertaking quality warehousing. Even the delivery of drugs in case of emergencies stands inefficient in our country. Despite the good intentions of aid agencies, non-governmental organisations (NGOs), and individual and corporate donors, the unorganised distribution chain fails before the chaos inherent in humanitarian emergencies. This often leads to a proliferation of fake, substandard, and otherwise poorly regulated medical products. During emergencies, little about patients, their diagnoses, or medical history is collected at most health facilities. Drug quality signals can be difficult to spot when infrastructure is disrupted: Patients are seen quickly and only minimal information is recorded. For all of the aforementioned problems, Good Distributing Practices (GDP)

proves to be an effective tool in providing structure to the Indian distribution market. GDP ensure maintaining product safety and quality during distribution across the supply chain and this practice is of significant importance for the pharma industry. The GDP Compliance report for pharma industry demonstrates quality commitment and sound practices in the entire pharma distribution supply chain. India desperately needs to adapt to GDP. The certification should be made mandatory. The effective implementation of GDP will help in reducing the number of spurious medicines, owing to the end to end reporting guideline offered by it so as to track the supply chain back to the manufacturer in order to bring about orientation in the distribution. There is no initiative or emphasis from the government’s end for the encouragement of GDP which is why, about 10 companies in India are certified with it. GDP stands as a potential growth factor of the future of the pharma industry. This is why, the international standard, WHO GDP stands as the most important and most practical protocol for the distributors. The implementation of GDP would allow pharmacists to identify suspicious drugs before dispensing them and would facilitate more efficient product recalls. The estimated mark predicted by the Pharmexcil council appears to be on the higher side. However, with the knowledge and experience that India holds, it is quite feasible. Undertaking the necessary measures and structuring the pharma distribution market will lead to devising an effective and lucrative supply chain.

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MANAGEMENT

Pharmacovigilance in 2020 – future horizons and efficiencies in data acquisition,evaluation and risk management To manage the ever increasing volume of information, companies have turned to cost-effective resources. Jeffrey Ho, Principal Consultant, Navitas Life Science, highlights how the advent of technology will contribute to a more sustainable model of pharmacovigilance

THERE IS a continual increase in case volume, expanding sources of information and rising expectations from patients and regulators globally. How do PV functions achieve further efficiencies to continue meeting growing demands, make sense of data as quickly as possible and respond accordingly to ensure that patients safely benefit from medicines? Over a million adverse events (AEs) were reported to the FDA in 2015, a five-fold increase from the 206,000 reported in 2004. Additionally, industry benchmarking shows an acceleration of the CAGR of adverse events to at least 20 per cent in recent years. If this direction of travel holds, we would expect to see case volumes increasing by another 50 per cent by 2020. A myriad of factors is contributing to this change. These include increasing public awareness of safety; rising expectations from regulators implementing EMA ‘GVP-like’ regulations, but with local adaptations; fast track / conditional approvals; apps and websites for consumers to report AEs; new product launches; and patient support programmes. The bulk of these cases are reported directly to the marketing authorisation holders (MAH), regulators, or partners. Even in light of these increases, there is the long shadow of what is not reported, which by some estimates, is as much as 90 per cent of AEs. In addition, early indications from social media analysis suggest that these forums may not necessarily surface any unexpected adverse events, but could provide insight into real world data in-

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cluding misuse and methods of abuse. There is also more and more exploration of wearables in clinical trials along with public adoption of these technologies to monitor their own health. Along with this, digital assistants from companies like Amazon and Google are becoming more common in certain markets. It’s not to far fetched to imagine that in the near future, a patient will tell their smartphone that they take a medicine. This information could be sent to his/her primary healthcare provider and the MAH simultaneously near real-time. To manage this ever-increasing, but also variable volume of information, companies have often turned to vendors for more cost-effective resources. However, this only means that vendors are faced with the very same challenge that the MAHs faced. At the end of the day, if there are 100,000 hours of additional work that needs to be completed by a certain deadline, additional resources will need to be deployed, be it with the MAH or with the vendor. And even if this challenge is addressed in one year, it is likely that the same challenge will be faced again the following year – and the following year. It is also worth noting that the pharmacovigilance resources are not ubiquitous, and following the current path, there are indications that this area will face marked skill shortages. The convergence of these factors brings pharmacovigilance to a situation that is becoming untenable, and to address this, efficiencies must be identified. The natural areas to turn to for this are process improvements and more signifi-

Process improvements can certainly have a profound effect on the efficiency of data acquisition cantly, technology. Process improvements can certainly have a profound effect on the efficiency of data acquisition. For example, implementing clear, consistent global processes; eliminating redundancies; and reducing handoffs simplifies the flow of information and reduces the likelihood of mistakes. Judicious use of medical resources also enables for more scalability. However, some companies are approaching diminishing

returns on these types of improvements because there is still a core of work that will inevitably need to be completed regardless of how optimised a process is. This is where technology will play a prominent role. At the most basic level, common standards for safety information will reduce the double data-entry, or even triple data-entry often seen in ICSR processes. With the ongoing rollout of the more comprehensive E2B(R3) format, the same information can be consistently shared by MAHs, partners, and regulators without having to supplement the file format as was often the case with E2B(R2). It would be natural to see E2B(R3) as the de facto standard for moving information gathered via apps and other sources of safety information also. The more significant benefit will be process automation. Some technologies like OCR and translation have been available for a while but have recently reached new maturity levels. It is unlikely that automation in these areas will eliminate the need for human participation, but the role of the human will likely shift to more of a quality one, checking the output of the automation tool and refining the output where necessary. The key is that the number of human hours required in process will be significantly reduced, thus allowing for a more scalable model. Along these lines, but perhaps a little further into the future, the human will not only serve the role of refining the automation tool’s outputs, but also provide feedback to the tool so that the same mistake is not repeated. Machine

learning and AI are already being piloted by some organisations. By 2020, some of the pilots will be completed, and the industry will have a better understanding of how these technologies will contribute to a more sustainable model for pharmacovigilance. The likely areas to benefit will be narrative writing with natural language generation (NLG), triage and medical review. Using a risk-based approach, human time could be focussed on serving as a second set of eyes for more ‘interesting’ information. As the pieces come together beyond 2020, it can be imagined that new safety-related information is rapidly acquired, processed, and added to the data pool for signal detection. The trick is that signal detection will be like trying to find a needle in a haystack, when the haystack keeps getting bigger and bigger by the hour. This will lead to automated tools that continuously scan this pool of data for anomalies and promptly notify a safety physician or scientist to vet an observation. This will in turn bring any confirmed signal to a cross-functional team to determine if the benefit-risk for the product has shifted. Once a label change or risk management action is implemented, technology supporting the monitoring of real world data could help gather evidence on the effectiveness of the action, and any refinements could be made accordingly. Pharmacovigilance must find more sustainable models, and in the interest of ensuring patients can continue to safely benefit from novel medicines. This shift will need to happen soon.

RESEARCH UPDATES

Merck’s cancer drug Keytruda notches another trial success Keytruda is the only immunotherapy approved in the US to treat lung cancer patients who have not received prior treatment

erck & Co said its drug Keytruda helped patients with a certain type of lung cancer live longer and prevented the disease from spreading, helping to solidify its position in the lucrative cancer market. Keytruda, already approved for other types of cancer, is being studied in a latestage trial as a first-line treatment, in combination with chemotherapy, for metastatic squamous nonsmall cell lung cancer (sNSCLC) patients. Merck said the combination therapy met its main trial goals when compared to patients who were on chemotherapy alone, according to an interim analysis. Earlier this month, Merck reported data from an interim analysis of the trial that met a secondary goal of overall response rate, or the portion of

patients with a reduction in tumour size. Merck had submitted a marketing application to the US Food and Drug Administration for the sNSCLC indication recently. “We doubted that Merck would submit the study for

FDA approval based on overall response rate if it did not have confidence in the primary endpoints,” said BMO Capital Markets analyst Alex Arfaei. Analysts were looking for the latest data to support the company’s application for an

expanded approval. Vamil Divan from Credit Suisse said, “We already knew Keytruda showed a benefit on overall response rate, but prolonging survival is obviously what matters.” Credit Suisse estimates that the areas in which

Keytruda has now shown positive data represent a market opportunity of $6.6 billion in first-line non-small cell lung cancer in the United States. Keytruda is the only immunotherapy approved in the US to treat lung cancer patients who have not received prior treatment. Merck has been expanding its position into the lung cancer market through Keytruda. Also jockeying for a piece of the lucrative market are drugmakers Bristol-Myers Squibb, Roche and AstraZeneca, which are advancing their rival immunotherapies. Merck said the new data will be shared with the U.S. Food and Drug Administration as part of its push to expand the drug’s label, and would be presented at an upcoming medical conference, the company said. Reuters

Johnson & Johnson scraps Alzheimer’s trials on safety concerns Some trial participants showed serious elevations of liver enzymes and the company concluded that the benefit-risk ratio offered by the drug, atabecestat, no longer supported its development JOHNSON AND Johnson said it would stop mid-stage trials testing its experimental Alzheimer’s drug after observing safety issues, the latest drugmaker to abandon developing treatments for the memory-robbing disease. Some trial participants showed serious elevations of

liver enzymes and the company concluded that the benefit-risk ratio offered by the drug, atabecestat, no longer supported its development, said Janssen, a unit of Johnson and Johnson. Atabecestat belongs to a class of experimental Alzheimer’s drugs called BACE

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inhibitors that block an enzyme involved in the production of a protein that creates brain plaques, which are considered a major cause for the disease. Analysts expect the successful development of a treatment for the disease, which affects about 5.7 million Americans, to virtually guar-

antee multi-billion dollar annual sales. However, several drugmakers, including Pfizer Inc, Merck and Co Inc, have been forced to abandon trials over lack of effectiveness or safety concerns. Eli Lilly & Co and AstraZeneca Plc are testing their

BACE inhibitor, lanabecestat, in late-stage trials and are due to report results next year. Johnson & Johnson was testing atabecestat to slow cognitive decline in certain patients identified to be progressing to Alzheimer’s dementia. Reuters

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June 1-15, 2018

RESEARCH

Regulators flag possible birth defect link to GSK’s HIVdrug GSK said it was notifying doctors of the issue and working with healthcare authorities to better understand the potential risk US AND European regulators said they were assessing evidence that GlaxoSmithKline’s HIV drug dolutegravir might be linked to serious birth defects, casting a shadow over a medicine that has been a key profit driver in recent years. Friday’s move by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) follows preliminary data from a study in Botswana which found four cases of neural tube defects in babies born to mothers who became pregnant while taking the drug. GSK said it was notifying doctors of the issue and working with healthcare authorities to better understand the potential risk. “There is no known mechanism linking dolutegravir with these types of birth defects and

there are no relevant findings in pre-clinical studies,” the company said in a statement. The EMA said dolutegravir should not be prescribed to women seeking to become pregnant and women who could become pregnant should use effective contraception while taking it. Neural tube defects (NTDs), such as spina bifida, are birth defects that can occur early in pregnancy when the spinal cord, brain and related structures do not form properly. Dolutegravir is a so-called integrase inhibitor found in the branded medicines Tivicay and Triumeq, which are sold by GSK’s majority-owned ViiV Healthcare unit. Gilead Sciences makes a recently approved rival product called bictegravir. The drugs work by blocking

an HIV enzyme to prevent the virus from multiplying, thereby reducing the amount of virus in the body. “Animal models are generally predictive of drug-induced birth defects and it is very unusual to see an effect in humans if no evidence is observed in animal models,” GSK said. The World Health Organisation already advises against using the drug during pregnancy or breast-feeding due to insufficient safety and efficacy data in this population, and this guidance remains unchanged. The role of dolutegravir in the four birth defects in Botswana has yet to be established, since NTDs are also associated with risk factors like folic acid deficiency and obesity. Reuters

Roche drug reduces bleeds in key haemophilia tests The positive results from the two trials known as HAVEN 3 and 4 included so-called non-inhibitor patients ROCHE’S NEW haemophilia drug Hemlibra dramatically reduced bleeding in a broad population of haemophilia patients, results from two clinical trials showed, setting it up to take a dominant market position. Hemlibra cut by 96 per cent the incidence of treated bleeds in haemophilia A patients who did not get preventive treatment, and compared with patients who did get preventive treatment in the form of clotting factors it reduced them by 68 per cent. The positive results from the two trials known as

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HAVEN 3 and 4 included socalled non-inhibitor patients. Hemlibra’s initial success was in patients with inhibitors, which are antibodies that cause resistance to replacement clotting factors. Hemlibra’s current regulatory approval is only for these inhibitor patients but Roche plans to submit the latest findings to authorities around the world to widen its use. While the drug’s latest success had been expected, the positive results seen in a wide range of patients should underpin demand for a medicine that Roche is relying on as sev-

eral of its blockbuster cancer drugs face cut-price rivals. Jefferies analysts said HAVEN 4 also showed there was a potential to treat both inhibitor and non-inhibitor patients on only a once-monthly basis. Currently, Hemlibra is given as a once-weekly injection. “This sets Hemlibra up to become the new standard of care for hemophilia A, which we view as a $5 billion peak sales opportunity,” they said. The current standard of care for people with haemophilia A without inhibitors is replacement factor

VIII clotting factor. Hemlibra will shake up the market and pose a threat to established players reliant on factor replacement therapies, notably Shire, which has agreed to be acquired by Takeda Pharmaceutical. Also being challenged are Bayer, CSL and Novo Nordisk, as well as Sanofi, which earlier this year bought US hemophilia specialist Bioverativ. New science also promises to bring further changes in the years ahead, with several companies working on haemophilia gene therapy, in which a harmless virus is used to introduce

DNA to fix the faulty genes behind the disease, offering a possible one-off cure. Data from the two Roche clinical studies were presented at the World Federation of Hemophilia congress in Glasgow, Scotland. “With this data, we now have positive results from all four of our Phase III trials that reinforce the overall efficacy and safety of Hemlibra and its potential to improve care for all people with haemophilia A,” said Sandra Horning, Chief Medical Officer, Roche. Reuters

PHARMA ALLY VENDOR NEWS

Werum ITSolutions to showcase latest innovations at Achema The company will show how pharma and biotech companies can generate knowledge from their production data DIGITISATION of processes, integration of software and equipment, operating concepts for the pharmaceutical shop floor or big data and analysis – Werum IT Solutions will present new answers for the digital pharmaceutical factory of the future at Achema from June 11–15, 2018. “A Manufacturing Execution System, MES, is the first and most important step for pharmaceutical and biotech manufacturers on the way to digitising their production,” says Lars

Hornung, Senior Director Global Sales & Marketing, Werum IT Solutions. “With live demos and interactive presentations, we will inform customers about the latest innovations around our PAS-X MES and Electronic Batch Recording – for example, KPI/OEE, Track & Trace and Finite Scheduling. A world first is PAS-X as a Service: our market-leading MES as a cloudbased solution. It allows pharma and biotech companies to save resources for their own

IT data centre and concentrate on their core business.” Another trade fair highlight is the easy integration of software and equipment using PAS-X MSI Plug & Produce. The machines on the shop floor and Werum’s PAS-X can communicate directly with each other via a standardised, message-based interface. It allows to reduce the integration effort up to 75 per cent. For this solution, Werum was awarded as Best Of at the Industriepreis 2018.

Innovative operating concepts which we know from everyday life will improve the pharmaceutical production and increase its efficiency. Together with its partners, Werum is developing solutions to integrate these concepts into its manufacturing IT solutions. At Achema, the visitors will learn more about the use of augmented reality and wearables in the pharmaceutical production. With its solutions for Enterprise Manufacturing Intelligence (EMI), Werum will show

how pharma and biotech companies can generate knowledge from their production data. This will enable supervisors and factory managers to obtain a deeper insight in the production in real time, as a basis for well-informed decisions and the optimisation of processes. Werum will be present at Achema both with its own stand (hall 11.1-A75) and at Körber Medipak Systems' stand, together with its sister companies (hall 3.1-J72). EP News Bureau

Clariant offers Sorb-It PHARMA desiccants for bulk pharmaceutical uses Filled with silica-gel desiccant, the new, Sorb-It PHARMA desiccant bags are available in a range of standard sizes for protecting bulk drugs, finished drugs CLARIANT, A world leader in specialty chemicals, and its healthcare packaging business line, has introduced Sorb-It PHARMA desiccant bags, an enhanced line of desiccants that are now produced in new ISO 15378 GMP certified facilties to comply with global standards for primary pharmaceutical packaging. Filled with silica-gel desiccant, the new, Sorb-It PHARMA desiccant bags are available in a range of standard sizes (50g, 100g, 200g, 250g, and 400g) for protecting bulk drugs, finished drugs during excursion (transport) and storage, active pharmaceutical ingredients (APIs), and work-inprocess. The new desiccant

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Clariant has the back-up capacity to meet the BCP (Business Continuity Planning) requirements of global pharmaceutical and healthcare customers

bags comply with US Pharmaceopeia USP<670> testing requirements for Auxiliary Packaging Components. “The introduction of SorbIt PHARMA desiccant bags marks a final milestone in Clariant’s plan to produce its pharmaceutical desiccant lines in ISO 15378 certified produc-

tion environments,” said Mark Florez, Product Manager, Clariant Healthcare Packaging. “ISO 15378 is gloally recognised by the pharmaceutical industry, and it is important that we offer our full range of products accordingly.” Florez explained that the new Sorb-It PHARMA product

line for bulk pharmaceuticals is the result of a recent investment by Clariant in a new ISO 15378 GMP certified facility at its Belen, New Mexico, USA, plant. Clariant already produces two other types of pharmaceutical desiccant products – packets and canisters that are used in finished drug product

containers – in ISO 15378 GMP certified facilities. Florez added that manufacturing equipment used to make all of these pharmaceutical desiccant products – desiccant bags, packets, and canisters – is operated under the same compliance procedures. Because it produces the same product at multiple sites, Clariant has the back-up capacity to meet the BCP (Business Continuity Planning) requirements of global pharmaceutical and healthcare customers. This includes the capability of Clariant to produce Sorb-It PHARMA desiccant bags not only in New Mexico, but also at its sites in Dongguan, China and Romorantin, France.

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Gerresheimer presents glass packaging solutions at InnoPack Pharma Confex The company produces glass vials, ampoules, and bottles that are specially designed for storage of high quality drugs GERRESHEIMER presented its glass packaging solutions at booth D6 at the InnoPack Pharma Confex, which was recently held in Mumbai. Gerresheimer’s Indian plants produce glass vials, ampoules, and bottles that are specially designed for storage of high quality drugs. These are all examples of primary packaging, which means they come into direct contact with their contents. For pharmaceutical applications, they must therefore be manufactured in line with the stringent requirements of the relevant pharmacopeias. After all, the packaging must allow drugs to be stored safely until their use. Gerresheimer has two plants at its site in the Indian city of Kosamba: The recently constructed Gerresheimer plant manufactures vials and ampoules for the pharma industry using tubular glass, while neutral glass makes moulded glass products for pharma applications and only very recently put a new highperformance furnace into operation. “The technical features of our new furnace for type I glass

has significantly enhanced our quality levels to meet growing demands of pharmaworldwide,” says Sachin Sule, Head of Sales & Marketing. Most importantly, he explains, the glass is considerably more uniform thanks to an improved electrical boosting control during processing. The state-of-theart furnace has also a higher pull rate, he adds. To coincide with the construction and upgrade work on the new furnace, a clean room inspection area was also built at the cold end, complete with new camera inspection systems to guarantee a comprehensive examination of the finished products before “safe packing”. Neutral Glass is set up to produce different types of glass at the same time. Here, for example, Gerresheimer manufactures clear and amber glass infusion and injection bottles from type I borosilicate glass. The company also produces type III glass containers for a large number of drugs. The production line at this factory is certified in accordance with DMF (Drug Master File) type III requirements.

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Gerresheimer has two plants at its site in the Indian city of Kosamba: The recently constructed Gerresheimer plant manufactures vials and ampoules for the pharma industry using tubular glass “Our new plant in Kosamba produces ampoules and vials made from borosilicate glass to the same high quality standards as apply in Europe or the Americas,” says Saibal Sengupta, Director Sales, Gerresheimer, who was at

Innopack Pharma Confex in Mumbai to advise customers and other interested visitors looking for a suitable solution for their drug. “All of our production and inspection processes are internationally standardised and certified.” The new plant is certified in accordance with the following standards: ISO 9001:2015, US DMF Type III, Health Canada (DMF), and ISO 15378. Gx Rhoc, the camera inspection system developed by Gerresheimer, ensures exceptional dimensional quality for vials. Several HD cameras detect every flaw. Vials are amongst the world’s most popular pharma packaging solutions and Gerresheimer produces versions in clear and amber glass that can hold between 1 and 50 ml. The range of tubular glass vials on offer in Asia includes clear and amber glass type I. All manner of different shapes are available, either with or without blowback and compliant with either international standards or the customer’s own specifications. Gerresheimer’s wide range of high-quality pharma am-

poules made from pharma glass type I includes ampoules made from clear and amber glass that can hold between 1 and 30 ml. Among these products are straight-stem, funneltype, and closed ampoules that comply with the relevant ISO standards (types B, C, and D) with various break systems such as OPC (one point cut), CBR (color break ring), and score ring. Customer-specific requirements can also be implemented alongside the major ISO standards. Gerresheimer’s full global range encompasses all classes of glass used for pharmaceuticals – types II and III sodium silicate glass as well as type I borosilicate glass. This enables the company to supply the perfect glass packaging to suit drugs of any shape or size. Its extensive glass range means that appropriate packaging solutions can be found for even the most sensitive pharma. With its Duma and Triveni brands, Gerresheimer also offers plastic containers in line with international requirements. EP News Bureau

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June 1-15, 2018

PHARMA ALLY PRODUCTS

B&R presents powerful Edge Controller at Hannover Messe

B&R India launches B&R showcases enhanced customer ACOPOStrak at support Hannover Messe

A SINGLE device to acquire data, evaluate it and send it to the cloud – that is now possible with B&R’s Edge Controller. The powerful industrial PC can even be used for big data analysis and machine learning, while at the same time serving as a fullfledged industrial controller. B&R’s Edge Controller is based on the robust Automation PC 910, whose high-performance variant is equipped with an Intel

B&R INDIA has launched World Class Support – a dedicated support hotline that will serve as a single point of contact for its customers nationwide. Customers served by B&R India headquarters in Pune and its six branch offices will now have a single number to call, ensuring that they receive a consistently high level of support with the fastest possible response times. “We are proud of the best-in-class service and support we offer our customers,” says Jhankar Dutta, Managing Director, B&R India. "Our World Class Support hotline will further enhance our customers' experience, in turn enabling them to offer their customers faster service and reduced machine downtime."

XEON processor able to handle resource-intensive tasks like machine learning. The Edge Controller runs a hardened operating system – a commercial Linux variant with guaranteed long-term support. Cloud transmission occurs via MQTT. Full-fledged industry controller B&R Hypervisor makes it possible to simultaneously run a real-time operating system on the Edge Controller. That turns the edge device into a full-fledged industrial controller with cycle times in the sub-millisecond range. An unlimited number of I/O modules or controllers can be connected via the POWERLINK Industrial Ethernet protocol, OPC UA or other fieldbus systems. In the future, this will also be possible with OPC UA TSN.

B&R’s online support portal allows customers worldwide to create and track support requests and share support documentation via the B&R website. With the new hotline, customers of B&R India also benefit from streamlined telephone support from a local team of experts. “Our highly qualified support team is committed to our customers’ success and has the expertise it takes to help them gain a competitive edge in their market,” says Ravishankar Gawhade, Head of National Support, B&R India. The number for the World Class Support hotline is +91 83 80 800 008.

AT THE Hannover Messe, B&R showed for the first time how ACOPOStrak can be combined with conventional conveyor belts. This brings the flexibility of the intelligent ACOPOStrak track system together with the low cost of a conveyor system – the perfect recipe for more cost-effective mass customisation. One intelligent station on the path through the production line is all it takes to create a mass cus-

tomised product. Product transport is handled almost entirely by low-cost conveyor belts – except for the one station where the products are personalised. That's where the intelligent ACOPOStrak comes into play. Since both systems use the same guide rails, the transitions between them are seamless. ACOPOStrak combines the motor and electronics into a single unit with the power electronics and a powerful processor integrated right in the motor housing. No additional inverters or motion control units are required, making the intelligent transport system extremely compact. Thanks to the modular design, it is easy to integrate ACOPOStrak segments of various lengths into an existing plant.

Contact details: Corporate Communications, t +43 7748 6586-0, press@br-automation.com, B&R Industrial Automation, B&R Strasse 1, 5142, Eggelsberg, Austria

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June 1-15, 2018

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Bosch presents newXelum R&D AT ACHEMA 2018, Bosch Packaging Technology has introduced its latest R&D device for the continuous production of oral solid dosage (OSD) forms. The platform ensures a short time to market and optimum dosing of APIs. “The new laboratory device is based on our Xelum production platform that we presented last year,” says FritzMartin Scholz, Product Manager, Bosch subsidiary Hüttlin. “The separated process steps of batch production take place one after the other and without interruption. This leads to shorter cycle times, lower production costs and high flexibility.” With the Xelum R&D, Bosch offers a platform that offers an ideal start to continuous manufacturing. As opposed to the common complex mass flow rate, excipients and active ingredients are dosed as a discrete mass in the Xelum R&D. This makes it possible to dose

The new R&D device for the continuous production of oral solid dosage (OSD) forms ensures short time to market and an optimum dosing of smallest amounts of API

even smallest amounts of APIs of less than one per cent. The system doses, mixes and granulates individual packages, socalled X-keys, which continuously run through the process chain and are removed successively from the machine as packages into bins. “This way we reduce not

only process complexity, but also the system’s failure susceptibility, while increasing both accuracy and quality of the end product. Moreover, the product is traceable at all times,” says Scholz. Depending on requirements, up to four loss-inweight feeders can be used.

Since the Xelum R&D uses the same components for dosing, mixing and granulating as the Xelum production platform from Bosch, process parameters Page 2 of 3 are identical and can be directly transferred 1:1. “Scale-up becomes obsolete, which reduces development time and API usage, since elaborate tests are no longer necessary,” Scholz explains. Material flow from dosing to emptying takes place in a closed process (bin-to-bin) to ensure the highest safety. The benefits of the fluid bed Current continuous production systems for wet granulation mostly use twin screw granulators. The Xelum system relies on fluid bed processors – based on a proven technology developed by the Bosch subsidiary Hüttlin. In the fluid bed, granulation and drying take place in the same process chamber. “This eliminates the need to

transfer wet granules, which in turn has a positive effect on the system’s reliability,” Scholz emphasises. Pharmaceutical manufacturers obtain granulates with the desired characteristics – including unimodal particle size distribution, as well as excellent flow and tableting properties combined with high production yields. The controls of the Xelum R&D correspond to a modern production system. All relevant process parameters are continuously recorded. Both the production and the product transfer, as well as the cleaning process are recipe-controlled and ensure reproducible results. The userfriendly handling of the system is complemented by a DoE (Design of Experiment) software support. Contact details Fritz-Martin Scholz phone: +49 7622 6884-131 Website:www.boschpackaging. com

Phenomenex launches bioZen Series for characterisation of biotherapeutics PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has introduced bioZen – a new series of LC solutions for bioseparations in pharmaceutical, biopharmaceutical and academic research. The series encompasses both proven and entirely new media spanning two particle platforms – core-shell and thermally modified fully porous – along with new biocompatible titanium hardware. The initial bioZen product line features seven chemistries for the UHPLC and HPLC characterisation of biotherapeutics such as monoclonal antibodies, antibody-drug conjugates and biosimilars. The offering includes specific LC

chemistries for the analysis of aggregates and total mAb, intact mass and fragments, peptide mapping and quantitation, and glycan mapping. As an added benefit, all bioZen media, particle sizes and phases are available in Phenomenex’s new biocompatible titanium hardware, which minimises secondary reactions, carryover and other recovery issues to provide better overall reproducibility than stainless steel hardware. It also minimises the amount of time typically spent on column priming and does not interfere with protein or peptide integrity. The bioZen thermally modified fully porous media is produced with Phenomenex’s pro-

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prietary post-synthetic thermal treatment process, which improves particle mechanical strength and inertness, providing significantly better peak shape and fewer unwanted secondary interactions than traditional LC media. The thermally modified media pairs well with high-efficiency bioZen CoreShell Technology media which delivers increased resolution and sensitivity in shorter reten-

tion time windows. Both particle platforms undergo stringent QC testing to ensure consistent high quality, while all individual bioZen columns have QC protocols for specific biologic applications to confirm product performance and reproducibility. “The bioZen series springs from our close work with customers who wanted a comprehensive product offering to cover all of their bioseparations

needs,” explains Simon Lomas, Senior Manager of Global Product Marketing, Phenomenex. “This is an exciting and growing portfolio of novel particles, chemistries and biocompatible hardware, supported by our industry gurus, that all combine to help our customers overcome the many challenges associated with the characterisation of biologics.” Contact details Simon Lomas, Phenomenex, Inc. Phone: (310) 212-0555 Ext. 2267 E-mail: simonl@ phenomenex.com mail to:simonl@ phenomenex.com

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June 1-15, 2018

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Gandhi Automations’clean room high speed doors a necessity BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which one can limit the amount of dust and dirt in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process. Clean rooms have become integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the doors which needs to be chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website : www.geapl.co.in

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PHARMA ALLY HP - TLC

VALUE ADD

TLC,I – TLC & HP-TLC for auditable analysis WHOEVER HAD thought that the cumbersome and inefficient column chromatography would become THE HPLC that is all pervasive now. That is now happening with thin layer chromatography’s conversion to High Performance Thin Layer Chromatography, albeit late. TLC has been prescribed in the pharmacopeias since the 1970s, even for quantitative analysis by the scrape and measure in a UV spectro. technique. With the introduction of Instrumental TLC (ITLC) in the 1980s, many analysts switched to I–TLC. However, the progress of HPLC became rapid with many manufacturers investing in R & D. Anyone could “manufacture” a HPLC with parts, bought readymade from the market. TLC was not so lucky and hence its progress was slow. Further hindrance was caused by the poor acceptance of a European technique by the American authorities. The pharma industry, which actively invested in I – TLC (although incorrectly called as HP-TLC then) in the 1990s, slowly swung in favour of HPLC and made HPLC, the liquid chromatography method of its choice. HP-TLC i.e. I-TLC with USP chapter 203 methodology scores heavily on the features like sample visibility, speed, flexibility, high throughput, low cost analysis long instrument life and negligible maintenance. Each of this advantage is attractive particularly to developing countries, from economy point of view. In fact, HPTLC today is so fast and flexible, that one HP-TLC can even serve a radius of 5-10 kms and not just one lab or just one dedicated analysis. Government of India is pushing the concept of Central Instrumentation Facility (CIF) in order to make all government-owned analytical instrumentation accessible to the MSME and educational institutes. HP-TLC is the ideal technique in a CIF. The main drawbacks of traditional TLC are many because of lack of any SOP. Plates could be lab made or pre-coated, of any size upto 20 X 20 cm, undefined sample application size few samples per plate, long development distance and time etc. etc. Yet TLC was extremely popular, in its days, because of its simplicity, low investment and powerful separation ability using adsorption. Analysis techniques started becoming

visionCATS HP-TLC Software + USP/PhEur SOP

INSTRUMENTAL TLC Shahrukh Bharucha, Sr Lab Manager, Anchrom

instrumental. This eliminated or minimised all the errors or variations caused by man e.g. circular ‘spots’ by pipette were replaced by ‘bands’ (6-8 mm long) sprayed on by gas, which dried the sample at the same time. So all bands on a plate, at start point, were of exactly the same size, a must for any chromatography technique. etc. But even I-TLC did not specify the plate size, length of bands, layer activity, development distance etc. So no one could really tell where TLC parameters ended and I-TLC began or for that matter, where I-TLC ends and HPTLC begins. There was considerable overlap and therefore, misunderstanding. USP Chapter 203 which became effective from August 2015, is SOP to follow, to claim ‘HP-TLC.’ It may come as a surprise to many that the same software and hardware i.e. HP-TLC specific software, spot or band application device and image documentation device together is usable for TLC or HP-TLC pharmacopeial analysis! One can do TLC very well by adopting some features of HP-TLC. Hence, the investment made in auditable TLC and HP-TLC is quite future proof. This system guarantees data quality, integrity and under 21CFR 11. Twin trough chambers are a must for development. Existing I-TLC users do not have to make any further capital investment but only adopt the USP SOP. It may be concluded that it is possible to do TLC in a regulatory compliant way, using latest HP-TLC software and instruments for sample application and chromatogram image documentation.

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System Software

TLC

For further info, users list, analysis and free training :

Anchrom Enterprises (I) Pvt. Ltd. 101, A Wing, Aniket Apartment, Navghar Road, Mulund (E), Mumbai - 400 081, India. Tel.: 091 22 21639928 - 31/7506792122 Fax : 091 22 21639927 E-mail : hptlc@anchrom.in Web : www.anchrom.in

TECHNOLOGISTS, NOT TRADERS!

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LABINDIA’s Auto Titrator: Essential for quality control and chemical analysis Sushil Bapat, Vice President - International Business, Labindia Analytical Instruments, gives an overview on titration which allows quantitative determination of a specific substance analyte dissolved in a sample PHARMACEUTICAL analysis is the quantitative measurement of the active ingredient and related compounds in pharma product. These determinations require the highest accuracy, precision and reliability because of the intended use of data as in drug formulation, stability evaluation and shelf-life prediction. There are several methods used in chemical analysis starting from simple manual method to complicated and sophisticated, one of this is titration. Titration is an analytical technique which allows the quantitative determination of a specific substance analyte dissolved in a sample. It is based on a complete chemical reaction between the analyte and a reagent (titrant) of known concentration which is added to the sample. The titrant is added until the reaction is complete. In order to prevail over the concern, LABINDIA has introduced Automated Laboratory Titrators. These are essential analytical instruments for quality control and chemical analysis. Both Auto & Karl Fischer Titrators are important laboratory instruments. LABINDIA titrators are compact design and are capable of detecting multiple equivalence points. TITRA SMART is provided with two-point auto calibration and standardisation (zero offset). The instrument is capable of displaying pH and mV of the sample, with temperature compensation. TITRA SMART can accept a variety of electrodes to cater to various applications in different fields. The liquid path comprises Teflon tubings, Teflon lined valve and gas tight burette with Teflon plunger head. It creates chemically inert system for any sensitive analysis. The in-

36 EXPRESS PHARMA June 1-15, 2018

Sushil Bapat, Vice President - International Business, Labindia Analytical Instruments

Automatic Karl Fischer Titrator (KAFI SMART)

Auto Titrator Smart

strument is supplied with high speed vortex stirrer with digital speed indication. This specially designed stirrer provides excellent homogenous mixing of samples. It is also user programmed

selectivity for report format, complying with GLP requirements, Compliant to ASTM D664, D2896 & D4739 for TAN and TBN analysis for oil samples. TITRA can be converted to

perform Karl Fischer titrations by simply changing burette assembly, all the specifications of LABINDIA Karl Fischer Titrator are applicable. The TITRA SMART is useful for titration types such as acid base titrations, non-aqueous titrations, Redox titrations, Argentometric titrations, Precipitation titrations, Complexometric titrations or EDTA titration, Voltametric titration / KF Titration, Silver Assay Titrations (As per BIS 2113: 2002), Blank titration etc. With these facilities it can work as acid base titrator, Redox titrator, Argentometric titrator, Precipitation titrator, Complexometric titrator, EDTA titrator. These are also used in different application industry i.e pharma and biochemistry, environmental and water pollution, food and beverages, dyes and chemicals, pesticides and fertilisers, petrochemicals, plastics and polymers, metallurgy and electroplating, jewellery industry. Automatic Karl Fischer Titrator (KAFI SMART) is an accurate, rapid and efficient method for determining the water content in samples. When the sample is titrated in the presence of SO2, I 2 and an organic base, moisture from the sample

extracted in the solvent, can be quantitatively estimated. Dry methanol is used as a solvent in Karl Fischer titration. Quick interchangeable imported burette assemblies with intelligent recognition for its volume size. Burette validation factor for dispensing correction is available for true end point volume. It quickly monitors and automatically neutralises moisture leak into vessel to keep it ready for next titration. It is used in different application industry like pharma, food and beverages, petrochemicals, cosmetics organic / inorganic chemicals etc. LABINDIA complies with Complete 21 CFR Compliant titrators with 6 password levels privilege options, audit trail and e-signature. Also it has the provision of 7’’ touch screen high resolution display with user interface and interactive software for ease of operation. Contact details Labindia Analytical Instruments HEAD OFFICE: 201, Nand Chambers , LBS Marg, Thane (W)-400 602 Tel: +91- 22- 2598 6000/ 2598 6110 E-mail: Sales.mfd@labindia.com Website: www.labindia-analytical.com

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LABORATORY EQUIPMENTS Laboratory Centrifuges

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Humidity Chamber with TFT Display Dry Hot Air Oven RDHO

Laboratory Stirrers Heating Incubator RHI

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Neya Centrifuges

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Walk in Chamber

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ZERO DEAD VOLUME SYRINGE (6cm, V6 & 3cm, V3) Syringes Designed for Customers' Instruments Requiring Precision Injection For General Liquid Handling Applications, Syringe Pump used in Chromatography Biochemical Filed Medical Inspection Industrial Instruments, etc German Technology PLUNGER HEAD SHAPES

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SQ1 Pharma1 Steam Quality Test Kit For Testing The Physical Properties Of Clean/Pure Steam In Accordance With HTM 2010/EN 285. Tests For : ª

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KILITCH HEALTHCARE INDIA LTD. Avoid the

Harmful Side Effects of Preservatives

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June 1-15, 2018

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

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OSMOMETER 3250

Milk Cryoscopes Available

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

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PVC RIGID FILM FOR BLISTER FORMING

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WE ARE CERTIFIED FOR ISO 15378:2011, WHICH INCLUDES BOTH ISO 9001 AND GMP

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PHARMA LIFE AWARD

Cadila Healthcare and Sun Pharma receive 2018 India Innovation Conference & Awards Organised by Clarivate Analytics, it honours India’s most disruptive innovators

larivate Analytics identified and honoured India’s top 12 innovative organisations at the 2018 India Innovation Conference and Awards held recently in Bengaluru. Cadila Healthcare and Sun Pharmaceutical Industries were among the top 12 winners. The evening’s keynote and awards were presented by VK Saraswat, Member at the National Institution for Transforming India, Government of India. Hosted by Clarivate Analytics, the award ceremony recognises and honours innovation ex-

cellence in India. The awards are based on an analysis that includes the size of the patent portfolio, grant success, extent of globalisation and citation volume. The analysis is based on

Derwent Innovation patent data including from the Derwent World Patent Index (DWPI) and Derwent Patent Citation Index. This year, 30 organisations were identified across six sub-

categories as the top innovators in India. The top 12 were awarded and honored at the ceremony in alphabetical order within their categories: India priority patents pub-

lished in the period 2015 to 2017 by companies headquartered in India were considered for this year’s awards, ensuring the awards recognise innovations that have originated from India and are created by local institutions. The criteria used to identify the top Indian innovators closely mirrors that of the Clarivate Analytics Top 100 Global Innovator annual report which highlights the most successful organisations in the world who are active in innovation through research and development. EP News Bureau

CAMPUS BEAT

BCP partners with Microsoft to enhance productivity The college has transformed its learning environment and operations, with anytime, anywhere access to coursework and research materials for faculty and students BOMBAY COLLEGE of Pharmacy (BCP) has partnered with Microsoft to enhance faculty-student collaboration and data security, to in-turn enhance course curriculum delivery, research and partnerships with industry. BCP students and teachers had been using personal email addresses, set up on different domains, for communication. This was causing inefficiencies in document collaboration and frequent instances of data loss, apart from a diffused online identity for the college. With the partnership with Microsoft, the college has transformed its learning environment and operations, with anytime, anywhere access to coursework and research materials for faculty and stu-

54 EXPRESS PHARMA June 1-15, 2018

dents, secure access to these materials and automation of routine workflows. The solution implemented at BCP includes the following: ◗ Standardisation of communication and identity: All emails were moved to Exchange Online, which is a part of Office 365 for Education. A hybrid active directory was simultaneously implemented that facilitates a single identity across all online experiences native to the institute – emails, network and internal sites. ◗ Enhanced productivity: Over 50 staff and 500 students were onboarded onto Windows 10 with Outlook 2016 that allowed them to store all their data securely on the cloud with OneDrive for business, and

have a secure internal interface for document sharing with SharePoint Online. ◗ End-to-end security: With Windows Defender, in-built into Windows 10, the data stored natively is highly secure. Windows Intune, that also formed part of the solution, allows the institute to apply security controls across devices and manage permissions remotely. Speaking on the partnership, Nitin Maniar, Chairman, Governing Body, Bombay College of Pharmacy said, “Our vision is to be a leader in education, training and research in Pharmaceutical Sciences. With the implementation of Microsoft tools, our productivity has increased by 25 per cent, and we are excited to see the

role of technology in nurturing our vision.” Rajiv Sodhi, General Manager – Partner Ecosystem, Microsoft India said, “Our mission is to empower individuals and organisations to achieve more. BCP has been a pioneering educational institute and we are proud to partner BCP as its students and faculty collaborate to lead advances in Pharmaceutical Sciences.” This solution is implemented by Microsoft partner, Techgyan which is a leading cloud service provider. Techgyan conducted a detailed study and identified the critical areas of intervention and helped in modernising BCP’s infrastructure to a highly secure end-to-end solution in Mi-

crosoft 365. Suresh Ramani, CEO, Techgyan added, “BCP had a large footprint of legacy systems. We took a strategic approach and looked at securing the core operations of BCP first and subsequently enhance collaboration among students and faculty by enabling Microsoft Teams, OneNote and Yammer. BCP is deploying its campus automation system on Azure, which will allow for further efficiencies.” The benefits to BCP have also included 75 per cent reduction in data loss, 50 per cent reduction in IT support calls, and 20 per cent reduction in email support calls. EP News Bureau

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