Express Pharma (Vol.11, No.6) January 16-31, 2016

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CONTENTS Vol.11 No.6 JANUARY 16-31, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas

SPARKS FLYAT EXPRESS PHARMA Pg12 DEBATE ON ONLINE PHARMACIES

MARKET

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap

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‘HEALTHCARE AND PHARMA SECTORS SHOULD WORK IN SYNC WITH EACH OTHER’

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8TH INT’L CONFERENCE ON YOGA & EDUCATION HELD AT KAIVALYADHAMA

DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

INTERVIEW

PHARMA ALLY

‘We would be happy to work with Ministry of Consumer Affairs to create an awareness programme’ Pg18

32 33

‘Most of our clients are repeat customers’

HONEYWELL ACQUIRES RESEARCH CHEMICALS BIZ FROM SIGMA-ALDRICH ZIM TO EXPAND ITS REFRIGERATED CONTAINER FLEET

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Pg29

P LIFE ‘We will continue to set our bar higher’ Pg30

‘The need of the hour calls out for a mindset change on how we manage employees’

MANAGEMENT

Pg54

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SYNGENE APPOINTS JONATHAN HUNT AS CEO-DESIGNATE

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AMRIT KARMARKAR AWARDED BY BEST PAPER AWARD SILVER IN 2ND INTERNATIONAL SCIENTIFIC E-CONFERENCE 2015

ACCESS TO MEDICINES: INDIA’S STRIDES SINCE INDEPENDENCE

RESEARCH

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CONATUS LIVER DRUG SHOWS PROMISE IN MID-STAGE TRIAL

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

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Online pharmacies both game changers and troublemakers

I

’d hazard a guess that there is hardly anyone who is not a user of e-commerce platforms to ease the daily grind. From the choicest groceries to the latest fashion accessories, most of us turn online. Then why is there so much ado about buying medicines online? Mirroring the push back to online grocery stores, representatives of the brick and mortar chemist stores point out that unlike a wrong size in shoes, which can be returned after a trial, wrong or worse, counterfeit medicines could have fatal consequences. But can we be sure that those we purchase in a nukkad ka chemist are not fake?

The Express Pharma team has watched the debate over online pharmacies being played out over the past few months in the country. The government responded by forming a subcommittee but sensing that many issues were simmering below the surface, we decided to launch a new platform called Vantage Point, and pose the question: Are Online Pharmacies Game Changers or Trouble Makers? We invited representatives from all sides to meet and thrash out their differences, and hopefully rise above the hype and white noise.

After months of silence, just a week before the event scheduled for January 8, with most offices winding down to bring in the New Year, the Office of the Drug Controller General (India) fired its salvo.

The Joint Drug Controller issued a circular on December 30, specifying that online sale of drugs contravened the provisions of the Drugs & Cosmetics Rules, 1945 and asked its officers to ‘put a strict vigil on the online sale of medicines and take action’ against those indulging in such activities. The DCG(I) clearly decided to play safe till the sub-committee came up with suggestions and guidelines.

The circular was hotly debated at the January 8 event. While there was consensus that the consumer should be protected with laws, representatives of the online and traditional chemists stuck doggedly to their stand. Each pointed out the shortcomings of the rival model with the legal eagles on the panel ruing the long drawn out law making process in India. (See full report:http://www.financialexpress.com/article/pharm a/latest-updates/sparks-fly-at-express-pharmadebate-on-online-pharmacies/191165/) India is not the only country where online pharmacies are facing the flak. The backlash to online pharmacies is a lot more organised in the US and EU, where the idea has been around a longer time. The website of the international Alliance for Safe Online Pharmacies, which

While there was consensus that the consumer should be protected with laws, representatives of the online and traditional chemists stuck doggedly to their stand

describes itself as a ‘social welfare organisation dedicated to improving patient safety on the Internet globally’ lists the actions taken against illegal online pharmacies across the world.

Is this merely the backlash that online retail stores faced and still face from local grocery stores? Most online pharmacies first start out as traditional brick and mortar stores, build a clientele and learn the tricks of the trade before they invest in online infrastructure. They then follow the aggregator model, where they aggregate the prescriptions from various chemist stores as well as take orders online. In fact, the panelist who represented traditional chemist stores readily admitted that some of their members are also looking at going online, but are waiting for the regulatory nod.

Given that India is still far from the US system of accredited online pharmacies, how do we detect and check abuse of the system? For instance, a recent study published in the Journal of Medical Internet Research (JMIR), is one of the first studies on how illegal online pharmacies are using Twitter to promote prescription drug abuse of controlled substances. The study authors found over 45,000 tweets that promoted drug abuse even though they only looked at a two-week period of tweets. One of the startling observations quoted in the study is that 76 per cent of the tweets that discussed drug abuse, had links to an online marketing affiliate advertising the sale of valium, a commonly abused tranquilliser that is supposed to be under controlled distribution.

The key word in the JMIR study is ‘illegal’ pharmacies. So, can an online pharmacy be immune from legal action merely by claiming compliance with the IT Act? Not so, claim some legal experts who point out that even as ‘intermediaries' to a transaction, Section 39 of the IT Act mandates that ‘the intermediary observes due diligence while discharging his duties under this Act and also observes such other guidelines as the Central Government may prescribe in this behalf.’ Which means that they can be held responsible if any of the medicines delivered by them are found to be spurious/fake, even though they merely delivered them. Have online pharmacies in India put sufficient safeguards into place?

The unwritten rule is that every segment will finally see one big player emerge as the market leader. Will we see bigger online pharmacies unite to weed out the ‘bad sheep’? Online pharmacies have already changed the game. It is now up to the regulators to rein in the troublemakers.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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‘Healthcare and pharma sectors should work in sync with each other’ Dr Suresh Saravdekar, Medical Consultant (procurement for Pharmaceutical and Medical devices) Municipal Corporation of Greater Mumbai, in a tête-à-tête with Raelene Kambli, points out that India needs a single healthcare policy to resolve its concerns revolving around affordability, accessibility and quality

Doctor, you have worked with some of the well-known public hospitals in Maharashtra. Can you tell us about your observations on the quality of medical devices used at these hospitals?

Medical devices are mainly classified into three categories. The first is high-end medical equipment such as MRI, CT scanners, X-ray machines, cath lab equipment etc. The second category is OT equipment and surgical instruments and the third is devices such as catheters, IV sets etc.

Before 2005, manufacturers of medical devices enjoyed free import duty. However, in 2005, it came to light that some material, devices and stents were brought to JJ Hospital for clinical trials without prior permission and an import license for those products. Consequently, the FDA seized those medical devices and stopped all clinical trials at the hospital. This case highlighted the need for regulation in this area and the government released the first circular in 2005 stating compulsory import license for medical devices. Under this circular, only four to five medical and surgical devices such as catheters and IV sets would get free import license but they required a Form 10 issued

by The Central Drug Standards and Control Organization (CDSCO).

Currently, at government hospitals, medical devices used are of good quality especially, when it comes to radiology and OT equipment. Moreover, there are only few MNC compa-

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nies that manufacture these high-end products which is why there is less choice as well. In the second category of medical devices like stents, heart valves etc., till 2010 the market was dominated by multinationals such as Medtronics, Abbott, Boston Scientific, and some more. But now there are some Indian manufacturers of stents as well. However, doctors still prescribe stents made by multinationals, even at government hospitals, as the indigenous ones do not have US FDA approvals.

What is your opinion regarding the quality of medicines?

Where medicines are concerned, I would like to cite examples from the Parliamentary report published in 2012 on the functioning of the CDSCO. The examples highlight how drugs are being brought into India without conducting clinical trials. This is happening because in India, we have two FDAs, one handled by the central government that takes care of making policies and the state FDA that provides licenses to drugs. Which is why there are so many loopholes. For example, say a drug that is declared substandard in Maharashtra is sold in Kerala and other states where they get easy approval. The worst part is that there is no proper data available on these subjects.

So, do you think India requires centralised control for drug licensing?

Yes. I completely agree that

Medical education for doctors should also cover areas of pharmacy so that they have a better understanding of drug quality, licensing policies and the laws around it

India requires centralised and more co-ordinated control where a high level of transparency is maintained. In 2012, the Parliamentary report did call for centralised control and the same was repeated in 2013 as well but no work has been done in this area. I feel the main reason for no improvement in this area is because our healthcare, drug and medical device policies are very pro-industry and not pro-health. This is the reason why pharma policies are put under the Ministry of Chemical and fertilizers while the healthcare delivery segment falls under the Ministry of Health and Family Welfare. In contrast to this, world over, economies have healthcare and pharma industry work in tandem with each other and are covered under one standardised health system. But here in India, pharma and healthcare sectors have no corelation. They function on parallel tracks.

medical devices, these two industries should be covered under the Ministry of Health.

What is your opinion about the drug procurement process in hospitals? How can it be utilised to provide quality services?

The problem with drug procurement agencies within both the government and private hospitals is that this responsibility is given to doctors who are not well versed with laws and implications of the licenses. So, there is a need to educate these procurement agencies within hospitals.

Moreover, there is a need to also introduce filters in the drug procurement process within hospitals just like the system which has been introduced in Maharashtra. We have made WHO certification compulsory for companies. If they do not comply with these norms, their drugs will be rejected at once. This helps us to ensure quality supply of medicines to our patients.

Recently, Union Minister for Chemicals and Fertilisers, Ananth Kumar announced that the government will establish a separate ministry for pharma and medical devices sector in the next one year. What is your opinion on this move?

I don't think this move will help to improve our current system.

I feel that this dual policy system only disrupts the co-ordination between the sectors.

Healthcare and pharma sectors should work in sync with each other. Instead of making a separate ministry for pharma and

Public hospitals characteristically train future physicians. What measures can be incorporated into training programmes by public hospitals to improve the quality of services provided by the physicians?

Training is the best solution in this regard. Also, our medical education for doctors should also cover areas of pharmacy so that they have a better understanding of drug quality, licensing policies and the laws around it. raelene.kambli@expressindia.com

MARKET POST EVENT

8th Int’l Conference on Yoga & Education held at Kaivalyadhama The conference saw luminaries from different schools of yoga get together and discuss ways to inculcate yoga in our lives through education THE 8TH International Conference on Yoga &Education was recently held at Kaivalyadhama, Lonavala near Mumbai, which explored ways to bring yoga into practice specifically through educating the youth of the world. The inaugural ceremony saw the presence of Swami Adhyatmananda from Sivananda Ashram, Shripad Naik, Minister of AYUSH, Government of India and SC Khuntia, Secretary SE&L, Government of India. The four-day conference had debates, discussions and workshops, which tried to bridge in the gap between yoga and education.

A panel discussion was held which focused on the mechanisms, benefits and challenges in implementing yoga within the primary, secondary and higher education school systems. Issues were debated on the categorisation of yoga as a secular discipline versus yoga as a religious practice. Vivid discussions were held on the relevance of yoga therapy as an alternate remedy to modern medical ailments and the methods for the implementation of yoga in the medical education system.

Shirley Anne Telles, Chief Research Consultant, Patanjali Yogpeeth and Dr Sat Bir Singh Khalsa, Assistant Professor of Medicine, Harvard Medical School, discussed their research findings of yoga in schools. Discussions were held on the importance of making traditional yoga relevant in today’s modernised world, the benefits and challenges of implementing a standardised yoga module for education, and how to bridge the gap between scientific research and education.

The conference also saw presentation of four best papers and the winners were Deepti Kale, Dr AM Deshpande, Shrikrishna Vyavahare, and Dr Anand Bhavanani.

EP News Bureau-Mumbai

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MARKET

Sparks fly at Express Pharma debate on online pharmacies Traditional chemists favour ban,online siblings cry foul while legal eagles ask for speedy amendments

EXPRESS PHARMA, a leading publication from The Indian Express Group, flagged off the first edition of Vantage Point, a platform to discuss and deliberate on India’s most pressing and controversial topics. The debate on ‘Online Pharmacies: Game Changers or Trouble Makers’ was held on January 8, at Express Towers, Nariman Point, Mumbai.

The panel comprised leading names from the pharma industry. Dr Raman Mohan Singh, Director, Central Drugs Testing Laboratory, Mumbai, Ministry of Health and Family Welfare, Government of India ; Vaijanath Jagushte, Treasurer, The Maharashtra State Chemists and Druggists Association and Chairman-Constitution Reform Committee, Member Legal Committee, All India Organisation of Chemists and Druggists; and Dr Suresh Saravdekar, Chairman, Hospital Division, Indian Pharmaceutical Association, Maharashtra Branch; Puneet Kapoor, Director, Big Chemist; Mahendrakumar Bajpai , Advocate, Supreme Court of India, Director, Institute of Medicine & Law, Editor, Medical Law Cases – For Doctors; and Dr Gopakumar G Nair, Gopakumar Nair Associates. Viveka Roychowdhury, Editor, Express Pharma, moderated the discussion. The association partners for this event were The Indian Pharmaceutical Association, Organisation of Pharmaceutical Producers of India and Indian Drug Manufacturers’ Association.

The debate started with Roychowdhury shooting a question to Kapoor about his business model. Kapoor in his reply said that his online pharmacy platform can help increase access to medicine

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(L-R) Dr Suresh Saravdekar, Mahendrakumar Bajpai, Puneet Kapoor, Dr Raman Mohan Singh, Vaijanath Jagushte and Dr Gopakumar G Nair

throughout India. On being asked about the credibility of online pharmacists, Kapoor mentioned that regulation has to evolve and change and hoped that a new set of guidelines would be implemented soon.

When questioned on how this discounting technique works to draw customers, he replied saying that discounts offered by online pharmacies were from the capital being deployed, rather than compromising on the quality of medicines.

Countering Kapoor, Jagushte quoted from the recent DCG(I)’s notification dated December 30, which urged state and centre drug regulators to ‘put a strict vigil on online sale of medicines and take action against those indulging in online sale of medicines in violation of the Drugs And Cosmetics Act and Rules’. He said that AIOCD’s stand is to safeguard the people at large. He said that unless a legal framework is set up, online pharmacies should not operate. He further said that there should be an authentication process to ensure what has been prescribed is being dispensed. He also said that all stakeholders need to deliberate

Audience at the debate

on this subject before a stringent law is framed.

Saravdekar in his opinion, pointed out that there are several gaps in the present system like the absence of a central database on medicines. He gave several instances of noncompliance issues and self medication, which made online pharmacies a dangerous proposition.

Bajpai chipped in saying that healthcare is important enough for a special focus. He made a strong case for a time bound consultative process to change laws, pointing out that to wait till laws were framed would be a sure shot way to

harm the sector.

Singh said that the time has come to cope with new technology and the topic on online pharmacies is a burning issue in the regulatory sector. He said, “If we don’t adopt new changes, we will be falling behind.” He also indicated that the regulators were aware of the issues at stake and were working towards a resolution.

Nair stated that the time had come for technology to disrupt the current marketplace.

He further pointed out that with the advent of technology, certain amendments need to be done in law. “Online pharmacies are not violating the law of land.

With transition taking place, current irregularities will be eliminated. One has to prepare for change and things need to addressed well in time,” Nair added.

Apart from this, the audience comprising representatives from pharmacies, with different business models, also raised pertinent questions.

Though there was a consensus on the dire need for change in regulatory mechanisms, with inputs from all stakeholders, panelists remained divided on basic issues. This topic will no doubt be up for debate once the regulators make their move.

EP News Bureau-Mumbai

EVENT BRIEF JANUARY 2016 - APRIL 2016 28

Asia Pharma Expo 2016

27

PHARMA Pro&Pack Expo 2016

ASIA PHARMA EXPO 2016 Date: January 28 to 30, 2016 Venue: Dhaka, Bangladesh Summary: Asia Pharma Expo 2016 (APE 2016), the 8th international exhibition on complete pharma manufacturing technologies, will be beneficial to all participants from local business associates to international machinery manufacturers and API / bulk active manufacturers. through participation at the exhibition.

Contact details Email: mail@AsiaPharma.org Website: www.AsiaPharma.org

PHARMA PRO&PACK EXPO 2016 Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectables, ointments, dry syrup powder) packaging machineries lab and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key contractors.

Contact details PHARMA Pro&Pack Expo 2016 / Mumbai GPE Expo Global, 402-403, Abhijyot Square B/h Divya Bhaskar, SG Highway Ahmedabad 380 051 T: +91-79-40008233 / 40008253 E:mail@PharmaProPack.com W: www.PharmaProPack.com

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

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cover )

Securing the supply chain, environmental sustainability and updation of technology infrastructure will be the buzzwords

BY USHA SHARMA

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PACKAGING SPECIAL

G

lobal markets today are flooded with falsified medicines, posing a perilous threat to the pharmaceutical industry and patients alike. It tarnishes the goodwill of the pharma companies who are unaware about the counterfeits making their way to their supply chain system. This chain typically consists of manufacturers, wholesalers, distributors and pharmacies before the medicines are made available for the end consumers at the pharmacy store.

In such a scenario, track and trace technology plays a crucial role for any pharma supply chain. It avoids security lapses and works to the advantage of pharma companies. Track and trace regulation is one of the tools which aims to stop the illegal and dangerous counterfeit medicines from reaching the end consumers and ensures that all the products are easily identified. It helps in labelling the drugs and ascertains easy tracking at every level of the supply chain.

Report on track and trace in the pharma industry is based on the experience of the team at ACG Inspection in various countries across the globe, particularly, Brazil, China, India, the US, Turkey, Saudi Arabia and Europe.

Most of the regulatory authorities across the globe are creating a two-step policy to implement track and trace regulations. The first phase is to implement serialisation at multiple packaging levels. The second phase is to implement an electronic pedigree, where companies will create a relationship between various packaging levels and share data across the supply chain.

There are many regions where pharma regulatory systems are weak, due to which, the probability of spurious drugs increases. Globally, the importance of implementing a comprehensive track and trace system is to monitor the entire production

(

THE MAIN FOCUS

TRACKAND TRACE CRUCIALFOR PHARMASUPPLYCHAIN Serialisation, when followed diligently, results in economic benefits, better brand protection, and secures customers’ confidence in the brand as well as the company.

and distribution cycle of pharma products has grown strong.

With disciplined rules and regulations, guiding the supply chain system of pharma companies, standardised identification solutions are sure to put an end to spurious medicines and secure the health of consumers worldwide.

Electronic pedigree

Serialisation The challenges, which the pharma industry face today, include counterfeiting, theft, diversion, and false returns to manufacturers. This is because the product passes through a complex distribution network where its authenticity at every level cannot be checked due to the absence of data-sharing systems. Serialisation makes every product unique and, therefore, it is believed that effective serialisation of medicines would cut down any chances of counterfeiting in the supply chain.

Serialisation involves printing a unique serial number on every product in addition to other details such as batch number, shelf life and Global Trade Item Number (GTIN). It provides visibility and full traceability throughout the supply chain. Many regulatory bodies have built their framework around the GS1 Standard.

Serialisation is done across various levels of packaging and

SIDDHANT BHAMBHANI Business Development ACG Inspection Systems

these are defined under three specific categories — Primary, secondary and tertiary.

At the primary level, pharma companies use a GS1 2D Data Matrix to barcode products such as blisters, injections, mono-cartons, etc. (Currently, this is not being enforced in a majority of countries).

At the secondary level, all the primary level packs are clubbed together as a parent unit of primary level packs and only one barcode is given to it with complete essential information.

At the tertiary level, only the final packaging is chosen to identify every lot of the product, ensuring no malfeasance in the supply chain.

Success in serialisation is achieved through vigilance, planning and implementation.

The pharma supply chain is really dynamic and complex, and although a majority of the prescription drugs consumed by patients are safe, there are several opportunities to introduce a counterfeit drug into the supply chain. Serialisation was the first step towards attacking the counterfeiting markets. With the first phase in place, a customer would be able to tell if the products were genuine or not, through a simple verification process.

When a spurious drug enters into the system, the first question that arises in our minds is where and how did it enter into the system? As the pharma supply chain is really complex, there are multiple potential places from where the counterfeit drug could have been introduced into the supply chain. This is due to the lack of information visibility throughout the chain. In order to address this, regulatory boards are enforcing the implantation of an electronic pedigree. This contributes to protect the supply chain from any mishaps. It also helps pharma companies to address problems of counterfeiting wherever and whenever it arises, as data is recorded and

Serialisation makes every product unique and, therefore, it is believed that effective serialisation of medicines would cut down any chances of counterfeiting in the supply chain

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shared at each and every point in the supply chain.

An electronic pedigree encapsulates all the details from sales to purchases made as well as trading of the drugs and their date of transactions through an electronic medium. The main purpose of the electronic pedigree is to safeguard consumers from counterfeit medicines.

The electronic pedigree is an auditable electronic record to track and trace drugs as they move from manufacturing unit to the end users. Its accuracy ensures safe and healthy drugs for consumers.

The benefits of an electronic pedigree ● Authenticates pharma products for safe consumption ● Automates internal procedures ● Improves efficiency and reduces cost of operating ● Improves accuracy and visibility of inventory information at various levels ● Improves inventory control

The overall opportunity v/s risk We need to be aware about where these steps will lead to.

A few basic assumptions are: As regulators accede to industry demands, who is the apparent ultimate winner or loser?

What segment will be benefited or damaged? The consumer, as it exposes him to harm or the industry as it lags behind its global competitors?

It mostly depends on how objectively the norms and the laws are designed and implemented. The expertise implicit in serialisation and secure packaging should be easy to understand and implement.

Harmonisation at global level will not only be beneficial to the consumer world, but will also help various industrial players to implement efficient and universally proven solutions. Further, it will also ensure secure traceability of the entire supply chain at a global level.

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cover )

P

harma PET bottles containing liquid solutions were banned in India, though the scientific basis of it is still in doubt. National Green Tribunal and Supreme Court of India are pursuing cases against plastic and other solid wastes generated due to various packaging applications, especially against 'single use' packaging.

Regulation and sustainability Regulation by courts, if not the governments, seems to be the future trend in waste management, water management and larger area of sustainability. It is the right point for companies and pharma industry to look and build structures, which not only comply with the present and upcoming regulations but reap them financial reward.

Inherent sustainability Energy, water and waste streams: Reducing energy footprint in manufacturing the packaging in partnership with the vendor would benefit both. More importantly, pharma waste disposal in water systems has a negative feedback effect on pharma industry across its value chain.

For instance if antibiotics waste is dumped in a river, downstream population using the water would become drug resistant over a period of time.

Once the disease occurs taking a more virulent drug resistant form, the present drug sales will drop and the R&D investment would be lost. Even if the drug is generic, the sales drop would impact the companies’ manufacturing and selling this particular drug. They would lose the market. A simple act of dumping waste water done by an employee or a process would impact the company. This is the financial and economic impact of environmental sustainability.

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PHARMAINDUSTRYNEEDS TO LOOKAT ENVIRONMENTALSUSTAINABILITY Pharma packaging, communication and adherence to drug dosage A peer-reviewed study published in Clinical Therapeutics of more than 3.1 million Walmart pharmacy patients and MWV’s Shellpak calendar blister packaging concluded that “a Shellpak-based adherence strategy could provide a substantial cumulative public health benefit when broadly implemented over a large population. Not only does increased medication compliance reduce hospitalisations, nursing home stays, lost work days, etc., but greater refill adherence can also result in financial benefits for pharma manufacturers—an increase of eight per cent to 14 per cent, estimates suggest. And industry knows the impact of eight to 14 per cent sales increase.

The above point has two components ● Firstly, the responsibility of the pharma companies is much more than just researching and manufacturing the drug ● Secondly, communicate through drug packaging in a way that the impact is felt across the value chain; the patients’ health, hospitals, doctors and the finally the company’s profitability.

Would not this be ‘real’ sustainability, the real profitability, rather the ‘true value’ of any drug? Can we start thinking in terms of ‘value’ rather than our cost-centric strategies?

Excess packaging and extended packaging We see many pharma packs containing multiple layers of materials. Is this excess packaging really required? Rather than working on reducing the weight

PRANAYKUMAR Chief Environment Officer, Vasudha Ecofriends Projects

The pharma industry just has to look at environmental sustainability to see the reflection of profits and value delivered for all the stakeholders of its products, the life-saving drugs

of each layer, can we work on reducing the number of layers?

Can we use alternatives of PVC (a known carcinogen), such as PET, which by the way will also pre-empt the regulation against PVC blisters and its waste?

Can we work with the retailer to reduce, if not completely eliminate, polyethylene bags given with each medicine? Can we go beyond the manufacturer’s responsibility and contribute to reduce environmental degradation due to landfill waste?

Environmental sustainability includes financial sustainability.

The pharma industry just has to look at environmental sustainability to see the reflection of profits and value delivered for all the stakeholders of its products, the life-saving drugs.

Implementing sustainability across the value chain The pharma industry in India can embed environment sustainability strategy in its corporate strategy (first of which is appointing a Chief Sustainability Officer with cross functional expertise and authority). The question maybe asked, Why? These maybe due to any or a combination of the following factors. They are increasing or maintaining brand reputation/value (CIPLA); ambition for social and environmental leadership (P&G); need for competitive advantage; stakeholder pressure (as happened to Indian Pharma companies in the US, Russia etc.); rising energy costs (as in many units in Gujarat, reducing impact through solar and energy efficient installations), and last but not the least pre-empt

regulatory compliances.

Challenges to implementation ● Budget challenges ● Difficulty in demonstrating

Return on Investment (RoI) Fear of disrupting present processes and even mindset ● Lack of knowledge of implementation and its impacts ●

Action for implementation ●

Incorporate sustainability matrix across the value chain ● Adopt or expand sustainable sourcing of materials and sustainable materials (like biodegradable plastics ● Implementing staff and customer collaboration and education initiatives ● Redesigning products ● Work on carbon, water and energy footprint

Impact of sustainability implementation An Aberdeen Group, May 2009 report on sustainability states how profitability has been increased drastically by taking small steps by top 20 per cent of an industry. (Reduction in percentage is marked as –ve and increase as +ve) Say, if one objective of compliance in packaging delivers better profitability and adherence to doses, thus greater value, then it should be considered as part of the whole healthcare economics analysis and not looked at as some add-on feature. Also, conflating CSR with environment sustainability is to be avoided, whether due to lack of knowledge or as a greenwash gimmick.

One thing sustainability creates is evaluation of all impacts and benefits side-by-side. Since medications have a much larger social, environmental and economic impacts, the pharma industry in India need to look at total value delivered to all stakeholders.

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he Indian pharma industry contributes to research and development, clinical research and laboratory testing for a wide range of generic and branded drugs. This industry also exports such drugs globally, contributing to India’s international growth.

The global pharma industry includes countries that either manufacture or consume pharma and healthcare products/services. Globally, the industry is complex, and is characterised by varying standards of trade, operation, compliance and technology use. Typically, developed nations have better regulation and governance to manage citizen healthcare, but is accompanied by a high cost of healthcare. In comparison, growing nations typically have a lower cost of healthcare.

Technology and its role in the Indian pharma industry Serialisation and track and trace technology is a big part of the global commerce industry, as well as for the pharma industry in India. With mega trends like

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THE SOLUTION LIES IN CLOUD TECHNOLOGY big data, cloud and the Internet of Things, we anticipate that adoption will continue as the Indian pharma industry matures and as machine data generated reaches a tipping point that accelerates mass adoption.

As global and Indian pharma companies extend their reach, they will need to enable capabilities with these mega trends in mind that accelerate their success.

This includes: ● Manufacturers being able to track and trace all goods in their supply chain and know who specifically to reach out to when a recall is required ● Stakeholders understanding the Chain of Custody at both the ingredient and finished goods level ● Stakeholders in the Supply Chain being able to identify whether a product is genuine or counterfeit

KINGSHUK GHOSH Manager, HPE Software Professional Services, Asia Pacific & Japan, Hewlett Packard Enterprise

● Patients being able to scan a medicines and learn if they are likely to have an allergic reaction to specific ingredients in a drug

they are purchasing ● Patient being empowered with information about the drugs they consume ● Doctors being able to monitor if their patients are on schedule with a prescribed course of the drugs While India has created standards on serialisation and track and trace, many pharma companies are unable to comply because of limited investments in technological infrastructure, or in supply chain considerations including the size of existing packaging or additional packaging material – most of which is exceedingly high for generic drug manufacturers.

Pharma companies who have adopted such technologies are usually in the branded drugs space, and have to comply with regulations implemented by countries that they export to.

The local industry is lagging in

this area due to considerations including price sensitivity. That said, we have seen an encouraging trend of drug companies transforming their technological infrastructure, and enjoying huge advantages when exporting to a global audience.

Recommendations While we believe that India will see a fair share of serialisation and track & trace technology adoption in the future, there needs to be the ‘tipping point’.

There are two primary factors to this tipping point. First, clearly visible use cases which benefit the consumer beyond just drug regulation and second, increased consumer education to improve their expectations on drug companies and the medication they provide.

In fact, there are already existing technologies and services which reduce the high initial overheads that pharma companies incur in serialisation and track and trace, and the solution for this lies in the adoption of cloud technology. u.sharma@expressindia.com

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‘We would be happy to work with Ministry of Consumer Affairs to create an awareness programme’ ASPA's objective is to curb counterfeit products in various sectors and create an awareness programme on how to identify correct authentication solutions. Arun Agarwal, General Secretary, ASPA, in an interaction with Usha Sharma, feels that in order to address counterfeit problem, there is a need to educate the brand owners

What role does ASPA play in the Indian pharma sector?

Authentication Solution Providers’ Association (ASPA) was formed in 1998 with the objective to curb counterfeit products in various sectors. It is the only association of its type in the world which has a focus on the advancement of authentication technology and solutions. As an industry body of authentication solutions manufacturers, we encourage our members to adopt best practices, standards and usage of advanced technology in providing cost-effective anticounterfeiting solutions against counterfeiting. Today, our member companies are providing authentication solutions to more than 10,000 brands globally and many pharma companies are benefiting from solutions provided by our members.

On the other hand, as a social responsibility, we are creating awareness among brands owners and government authorities about issues such as importance of authentication solutions in fighting counterfeiting and how to identify appropriate authentication solutions according to their needs. We are

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already working with FICCICASCADE (Committee Against Smuggling and Counterfeiting Activities Destroying the Economy), Confederation of Indian Industry (CII), ASSOCHAM and Indian Institute of Packaging (IIP) and keen to provide our support to other industry trade association such as Organisation of Pharmaceutical Producers of India (OPPI) and the Indian Drug Manufacturers’ Association (IDMA).

Do you think that online pharmacies be allowed to function or banned in India?

Yes, the concern is correct and very serious. Online selling of products like medicines need clear regulatory guidelines, strong enforcement as well as adoption of solutions that can empower consumers to check the authenticity of medicines for themselves. If all these conditions are met, online pharmacies can definitely provide a safe, convenient channel for purchasing medicines.

Why do you think cases of counterfeit drugs or misuse of holograms are more prevalent

in our country and how to overcome with these challenges?

It is incorrect to say that misuse of holograms is prevalent in India. Holograms are one of the best proven technologies which is used from brand protection application to highly sophisticated application such as currency and passport protection. Holograms as a technology has a lot of potential if used and adopted correctly after carefully studying the problem of counterfeiting on case to case basis. That is the reason, as ASPA, we are creating awareness on how to identify correct authentication solutions, as the counterfeiting problem of FMCG companies cannot be similar to pharma counterfeiting. Further, there is also a need to educate the brand owners about the need to create awareness of their anticounterfeit feature to their end customers, so that the people look for the anti-counterfeit feature and can easily recognise the same. Moreover, a full-proof solution can be created by using other technologies such as security printing features, barcode, other various features can be added in holograms, which will provide three layers of

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We are creating awareness on how to identify correct authentication solutions, as the counterfeiting problem of FMCG companies cannot be similar to pharma counterfeiting securities. They are: ■ Visible and verifiable with naked eye ■ Visible and verifiable with portable (pocket size) readers ■ Visible and verifiable with Forensic Lab ■ Visible and verifiable on SMS, Web and Smart phone with app.

Also, India already has stringent anticounterfeit regulations for exports, and is contemplating similar regulation for domestically distributed drugs as well.

In fact, we are submitting our views on the same to the Ministry of Health and Family Welfare.

Do you agree that Indian FMCG is more regulated and transparent than pharma industry and the number of counterfeit is higher in pharma than FMCG? It is difficult to say. Measuring counterfeiting is methodologically challenging for various reasons. First, it is an illegal activity and illicit traders attempt to remain invisible and are unlikely to record their activities. Due to security reasons, data on illicit trade is usually difficult to obtain, as law enforcement agencies often prefer not to publicise the scope of their activity.

Furthermore, all methods to estimate illicit trade have their limitations and not all studies clearly describe their methodology of these limitations.

However, I would like to share an important finding from a report published by FICCI-CASCADE. Barring packaged foods, various industry sectors have shown an increase in grey market percentages. In the FMCG-packaged foods industry, the grey market percentage was estimated at 25.4 per cent in 2008, and 23.4 per cent in 2010.

The current study estimates it to have further fallen to 21.7 per cent in 2012. This may mainly be attributable to better use of technology and innovations in the packaging of products to prevent counterfeiting, which counterfeiters have not yet

been able to crack or replicate.

How closely do you work with the government in order to deal with counterfeit problem? Under the ‘Make in India’ campaign, what are your plans for the pharma sector?

Our industry offers several solutions to curb counterfeiting and our work not only protects, but also enhances government revenue. We help the government achieve its social responsibilities, as our solutions enable the common man to identify a genuine product and save himself from the perils of a counterfeit or adulterated product.

We feel that more and more government departments should look at our solutions to protect the various products and documents they issue in public interest. We would be happy to work with the Ministry of Consumer Affairs to create an awareness programme that will educate the people of our country about the perils of counterfeiting. The ‘Make in India’ initiative is extremely well thought of and is truly the need of the hour. ‘Make in India’ pharma product has great opportunity in India and overseas market because of their quality. However, with the increase of counterfeiting in pharma sector, there is a constant need to ensure that 'Make in India' pharma product is of highest quality, genuine and secured till its deliver to the end consumer. In us, it is ‘Make sure India.’ Our industry has developed various new generation authentication solutions which can be easily used in product packaging ensuring that a consumer gets the genuine product. Further, with the help of IT and mobile-based solutions, brand owners, government authorities and consumer can easily have identified them via website, mobile app or SMS verification. We are optimistic and look forward for positive responses from the government and industries to make pharma safe and secure in India. u.sharma@expressindia.com

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INSIGHT

Challenges of pharma coding in Arabic,Cyrillic and Asian languages

RICHARD NEMESI, Global Vertical Manager for Pharmaceutical and Medical Devices, Videojet Technologies,

Richard Nemesi, Global Vertical Manager for Pharmaceutical and Medical Devices, Videojet Technologies, opines that the main challenge is the sheer number of characters, which the printer needs to manage while coding in non-Latin language

I

n the last ten years, the development of the so-called pharmerging markets has provided Western drug companies with huge opportunities.

Developing economies in countries like China, India, Russia, South Korea, Brazil and Mexico have become major consumers of pharmaceuticals.

The IMS estimates that in 2014, pharmerging countries made up around a quarter of the total pharma market, and it's estimated that by 2017, this will rise to a third. In Saudi Arabia alone, the market is worth around $4 billion, with 70 per cent of imports coming from Europe and 13.1 per cent from the US. Whilst in the Philippines, the pharma market has grown to $4.3 billion1, with foreign manufacturers supplying 75 per cent of the market2.

With the increased use of pharmaceuticals comes the increased risk of counterfeit medicine. In pharmerging countries, physicians' concerns about poorly manufactured or counterfeit drugs mean they are more likely to write prescriptions for branded medicines rather than generics, with the brand acting as a guarantee of quality.3 The

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World Health Organization estimates that counterfeit medicines contributed approximately one per cent of the total drug supply in developed countries, however, up to 30–40 per cent in developing countries.

Global serialisation of pharma products using coding is being put in place as the best way of counteracting this problem, enabling the pharma industry and regulators to track the products through manufacture, distribution and dispensing through the use of coding.

Challenges of coding in non-Latin languages Data communication has now become an integral part of our everyday lives with the dominance of the Internet and devices like smartphones. In the world of electronic data handing, ASCII was the most used

code in data communication until 2007. It was developed from telegraphic codes used in the early 1960s and is based on the English alphabet with Latin characters, with the capability to encode a total of 128 characters. At the time, standard printers were built to handle the ASCII protocol. With ongoing globalisation there was a need to expand beyond the ASCII limit of 128 characters, hence the development of UTF8, which can encode over a million characters. It is currently used for more than 80 per cent of data communication because it incorporates all the extra characters, which are not included in Latin-based languages. UTF-8 is the standard system used to handle international characters contained in Arabic, Cyrillic and Asian languages.

Existing serialisation codes require human readable instructions to be in local languages and also machine readable symbols such as DataMatrix. In addition, there is detailed information required by national drug codes, which include a unique serial number for each item, plus packaging lot number and expiration date. As each saleable unit requires its own code and each code needs to be non-sequential, the demand for codes rises exponentially. The main challenge for pharma companies, when manufacturing for global markets using non-Latin languages such as Arabic, Cyrillic and Asian is the sheer number of characters the printer will need to manage. As a result, a specialised coding system with superior data handling is crucial for trading in these non-Latin language local markets.

Global serialisation timescales Currently, many of the pharmerging markets do not have the capacity to meet their domestic pharma demand, representing export opportunities for large pharma companies.

Serialisation regulations are

being planned and many formalised in a number of these markets, presenting a complex landscape for navigation aspharma manufacturers or supply chain player. The following is an overview of some of the important pharmerging markets that use non-Latin languages domestically, what is required by their serialisation regulations and when the important milestones are:

China In the past two years, China has been phasing in implementation of their track and trace regulations. With the final deadline on December 31, 2015, all of China's pharma products will be covered under the country's unique requirements, including serialisation and reporting. All levels of product will have to be serialised with a government-issued number.

Pharma companies will be required to run a query on a Chinese government system in order to initiate and capture the serial numbers. Since 2013, the Essential Drug List (EDL) covers 502 products that currently require serialisation. The EDL requires that the Chinese National Drug Code (NDC) plus serial number to be printed on

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primary and secondary packaging.

Korea Since the end of 2013, medicines sold in South Korea have been required to carry a 2D DataMatrix code containing the Global Trade Item Number (GTIN), lot number and expiry date. At the beginning of 2015, a new phased schedule for serialising medicines was introduced, and in 2016, there will be a requirement for a unique serial number to be incorporated into the code for almost one third of all pharma products sold in the country. South Korea's Ministry of Health and Welfare also hopes the use of serial numbers will help manage medication records and reduce the occurrence of misprescribing.

Saudi Arabia Since March 23, 2015, the secondary packaging of prescription drug products sold in Saudi Arabia must contain both a human readable and a DataMatrix symbol encoded with GS1 GTIN to identify the item, the packaging lot number, expiration date and pack size. From March 12, 2017, every prescription drug item must contain a unique serial number with all the above information and the number must be encoded in the DataMatrix symbol.

Jordan In Jordan, after January 1, 2017, all prescription drug items must contain both human readable text, and a DataMatrix symbol encoded with GS1 GTIN to identify the product, the packaging lot number, expiration date and pack size.

Eastern Europe and Russia Russia and Ukraine do have plans to introduce serialisation, though there are no confirmed time scales as yet. Russia

has introduced the Pharma 2020 plan that requires international players to form partnerships with domestic manufacturers in order to gain a foothold in the market. Similar plans have been drawn up by Commonwealth, Latin American and African countries. It is also worth pointing out that Bulgaria also uses Cyrillic language. As the country is part of the European Union, serialisation and tracking compliance will be required by January 2, 2017.

The increase in serialisation of pharmaceuticals worldwide means there are huge gains to be made by companies who have systems in place to handle compliance in Arabic, Cyrillic and Asian speaking pharmerging markets. Part of addressing the challenge for production teams will be selecting the right coding equipment that can meet the functionality required by variable codes at the necessary speed and quality levels.

Thankfully, significant innovation is happening across the industry, which is driving breakthrough changes in coding capability.

1. http://healthcare.globaldata.com/mediacenter/press-releases/ pharmaceuticals/ philippines-pharmaceutical-market-valueto-reach-8-billion-by-2020-says-globaldata 2. http:// www.pacificbridgemedical.com /publication/2014-philippines-pharmaceutical-market-update/ 3.Pharmerging Markets: Picking a pathway to success. IMG Consulting Group, 2013. Pg8 http://www.imsconsultinggroup.com/deployedfiles/consulting/Global/Content/Our %20Latest%20Thinking/Recent%20Topics/Q2%202013%20IMS%20Pharmerging%20white%20paper%2006-2013high%20res.pdf

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MANAGEMENT INSIGHT

Access to medicines: India’s strides since independence LEENA MENGHANEY Regional Head, MSF Access Campaign, South Asia

Leena Menghaney, Regional Head, MSF Access Campaign, South Asia, in this article, explores milestones in policies that have had an impact on the production, supply and availability of affordable medicines from 1947 to the present day INDIA’S JOURNEY in healthcare began with immense challenges – high rates of mortality due to malaria, TB, small pox, leprosy, malnutrition and infections, added to which were the highest drug prices in the world for the first generation of antibiotics and essential medicines.

Following independence, the drug supply situation in India was primarily dominated by what were then known as transnational corporations (TNCs) which imported a limited range of medicines. Drug prices were high and ungoverned, and profiteering was rampant. Local production by domestic companies like Chemical, Industrial and Pharmaceutical Laboratories (known as Cipla today) were blocked by the patent law which India had inherited as part of its colonial legacy.

Policy reforms However, innovative policy and legal reforms over two decades (1955 – 1975) resulted in India becoming a pioneer among developing countries in promoting indigenous manufacturing and technological capability in pharma products. This benefited millions of patients in developing countries by providing a source of affordable generic medicines.

As a first crucial step, the Indian government in 1957 appointed a parliamentary committee under the chairmanship of Justice Raja Gopal Ayyangar, which led to path

22 EXPRESS PHARMA January 16-31, 2016

times lower than the price at which Glaxo sold it in the UK.

Signing TRIPS agreement

breaking amendments to the Intellectual Property (IP) system, disallowing product patents (monopolies) on food and pharma products as well as limiting process patents to seven years. The amended Patent Act 1970, based on the recommendation of the Ayyangar Committee, stated that its objective was to foster the development of an indigenous Indian pharma industry and to guarantee that the Indian public had access to low-cost drugs.

To accelerate the production of medicines domestically, the government set up the public sector units to manufacture new drugs with the aim to build and strengthen domestic capacity in pharma products.

The production units were much needed for the produc-

tion of drugs like penicillin.

Indian manufacturers were still struggling to develop and manufacture active pharmaceutical ingredients (APIs) – the raw material - that determines the cost and efficiency of production. The 1974 Hathi Committee Report on Drugs and Pharmaceuticals gave a fillip to API production in the country by recommending that the import of bulk drugs by domestic manufacturers be discouraged; and mandating TNCs selling formulations in India to start manufacturing the API in India within three years.

Emergence of public R&D labs Simultaneously, public research and development (R&D) laboratories were also

set up in India. Of particular importance are the National Chemical Laboratory, Pune; the Central Drug Research Institute, Lucknow; and Regional Research Laboratory (later renamed as Indian Institute of Chemical Technology), Hyderabad. Between mid1970s and late 1980s, the scientists and organic chemists from these institutes developed efficient, cost-effective processes to boost API manufacturing. This enabled generic manufacturers to develop lowcost generic formulations of new medicines. By early 1990s the impact of technology transfer was evident- not only generic drugs were being produced from scratch but were far more affordable. In 1993, the price of an anti-ulcer drug ranitidine – in India was 16.58

Early 1990s also witnessed India’s initial but strong opposition to the inclusion of IP within the ambit of trade negotiations in the World Trade Organisation (WTO).

The weakening of India’s negotiations was one major contributing factor that led to the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Finally as a member of WTO and having signed the TRIPS agreement in 1994, India was mandated to change its pharma patent system by 2005.

Ironically, in the decade between signing the TRIPS agreement and the deadline to implement it, generic production from India was recognised for its critical role in the supply of affordable medicines in the developing world, especially for newer drugs such as antiretrovirals (ARVs) needed in the treatment of HIV. For example, the cost of first generation HIV treatment dropped from over $10,000 per patient per year in 2000 to $350 by 2001- thanks to generic competition from companies like Cipla. In addition, Indian manufacturers developed generic fixed-dose combinations that dramatically simplified AIDS treatment in resource-limited settings, including India. By 2005, India established itself as the global power house of

generic drug production and supply.

Amending the patent law Unfortunately, in 2005, India had to amend its patent law to become compliant with its obligations under WTO. In the midst of civil society protests and international media attention, the Indian Parliament approved and passed amendments to Patents Act on March 23, 2005. The Indian Patents Act of 1970 was thus amended to grant pharma product patents – something the country had not done since 1970.

The 2005 patent law not only put some serious constraints on generic competition but also had some potentially important features such as strict patentability criteria to prevent ever-greening; the right for anyone to object to a patent before it is granted; and compulsory licensing. The following decade is interspersed with several examples which affected access to affordable medicines, both nega-

ity requirement under the Indian patent law. The impact: price busting generic competition. The cost of the generic version of imatinib in India is $790 per patient per year compared to the patented version which is marketed by Novartis at $106,322 per patient per year in the US. Unfortunately, almost a decade after the first product patent was granted, India is drying up as a source of affordable versions of newer and future medicines. Patenting new medicines in India could mean that Indian manufacturers will no longer be able to automatically produce cheaper versions of newer medicines. Such newer drugs are crucial, for example, to treat TB, cancer and other critical diseases. But, only one compulsory license by the Patent Controller has been granted to increase competition.

The move brought the price of the patented liver and kidney cancer drug down from over Rs 280,000 per

Ironically, in the decade between signing the TRIPS agreement and the deadline to implement it, generic production from India was recognised for its critical role in the supply of affordable medicines in the developing world tively as well as positively. For instance in 2006, Roche proudly announced it was "becoming the first pharma company in India to receive a product patent under the new patent regime." The patent granted was on peginterferon alfa-2a (Pegasys), a hepatitis C drug, priced at the time at over ` 18,000 per injection.

At the same time, in the decade since product patenting system was introduced in the country, India’s patent offices and Intellectual Property Appellate Board have strictly examined and rejected several secondary (ever-greening) patent claims over salts, polymorphs, dosages, fixed dose combinations and child formulations of known HIV, Hepatitis, TB and cancer medicines.

Among them was the Swiss pharma company Novartis, which lost a seven-year battle to claim a patent on a new form of an existing cancer medicine. The Supreme Court ruled that claims on a new form of a known substance did not meet the patentabil-

month to ` 8,800 per month; a price reduction of 97 per cent.

Granting a patent in India will have a chilling effect for a number of years on generic manufacturing and supply.

A patented cancer drug lapatinib costs ` 445 a tablet. Newly developed drugs against DR-TB, Bedaquiline and Delamanid are under patent and thus highly priced or unavailable.

Need for a new IP policy Amidst rising drug prices and increasing US pressure to enforce the intellectual property of its pharma companies, India is now reviewing and drafting a new national IP policy, which will determine the future of generic competition and supply of medicines from India.

Prime Minister Modi now faces a challenge: future access to essential medicines for millions of people will depend on the new Indian government’s policies and the kind of patent system it endorses.

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WE UNDERSTAND VALIDATION AND CALIBRATION BETTER !

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RESEARCH RESEARCH UPDATES

Conatus liver drug shows promise in mid-stage trial The drug, emricasan, showed a statistically significant reduction in the protein fragment CONATUS Pharmaceuticals said its experimental drug reduced the presence of a protein fragment in patients with liver cirrhosis in a mid-stage trial.

The drug, emricasan, showed a statistically significant reduction in the protein fragment, caspase-cleaved cytokeratin 18 (cCK18), when compared with a placebo, in

the overall patient population, according to the three-month data. Patients with advanced liver disease and cirrhosis usually have higher levels of cCK18.

Conatus said the drug showed consistent improvement across additional liver disease biomarkers in the overall patient population.

The company said it expects

to report six-month data from patients who continued the treatment in the second quarter. The six-month data will also allow the company to determine if the mid-stage trial could qualify as a late-stage study, Conatus said. Emricasan is being tested for multiple liver indications.

Reuters

AstraZeneca gets US approval Gilead’s hepatitis B drug as effective for gout drug Zurampic US FDA wants AstraZeneca to conduct a study to further assess the kidney and heart safety of the medicine US HEALTH regulators approved AztraZeneca's drug Zurampic to treat a condition associated with gout to be used in combination with another type of drug that reduces production of uric acid in the body.

Zurampic, known chemically as lesinurad, works by helping the kidneys to excrete uric acid.

Gout is a painful form of arthritis caused by the buildup of too much uric acid in the body. "Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes," Badrul Chowdhury, head of the Food

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Zurampic, known chemically as lesinurad, works by helping the kidneys to excrete uric acid

and Drug Administration's pulmonary, allergy and rheumatology products division, said in a statement.

As a condition of the approval, the FDA said it will require AstraZeneca to conduct a study to further assess the kidney and heart safety of the medicine. The drug's label will include a warning alerting health-care professionals to the risk of kidney failure with certain unapproved uses, such as with higher-than-approved doses of Zurampic, the agency said.

Reuters

as Viread

There are plans to seek regulatory approval for TAF in the US and Europe in the first quarter of 2016 GILEAD SCIENCES said its experimental hepatitis B drug was found safer than but as effective as its approved treatment, Viread, in two late-stage studies. The oncedaily drug, tenofovir alafenamide (TAF), showed improved renal and bone safety compared with Viread, Gilead said.

The company plans to seek regulatory approval for TAF in the US and Europe in

the first quarter of 2016. The drugmaker said in September that TAF was found safer than but as effective as its popular HIV drug, Truvada, in a late-stage study. Patients given TAF experienced significantly lower loss of bone mineral density and kidney function than those on Truvada. Gilead is developing TAF as a safer replacement for Viread and Truvada.

Reuters

Purified marijuana compound may reduce stubborn epileptic seizures The researchers enrolled 214 patients between 2014 and 2015 from 11 US epilepsy treatment centres for the new study A PURIFIED compound derived from marijuana may help reduce seizures in children and young adults with severe forms of epilepsy that resist other treatments, a new study suggests. Patients who added a 99 per cent cannabidiol (CBD) oil to their current treatments went from an average of 30 seizures a month to fewer than 16 - representing a 37 per cent reduction over 12 weeks, researchers report in Lancet Neurology. “In this group that has been extremely treatment resistant, this was an incredibly positive finding with the caveat that we didn’t have a comparison group,” said lead author Dr Orrin Devinsky, of NYU Langone Medical Center in New York City.

CBD is a compound found naturally in marijuana and known to affect the brain. But it's important to note that CBD does not produce a high, Devinsky said, and the new findings have no bearing on use of medical marijuana or other compounds from the plant. The form of CBD used in the new study was a solution of the extract in oil called Epidiolex from GW Pharmaceuticals, which partly funded the new study. The drug is currently being evaluated by the US Food and Drug Administration.

Previous research into the effects of CBD and medical marijuana on various types of epilepsy has been limited and produced mixed results with some people having fewer seizures and others having more.

For the new study, the researchers enrolled 214 patients between 2014 and 2015 from 11 US epilepsy treatment centres. They included people with different forms of epilepsy like Dravet and Lennox-Gastaut syndromes. The participants were typically among the centers' most resistant to existing epilepsy treatments. The goal of the study was to inform future research by tracking doses, side effects and whether or not the patients improved.

Participants were started on 2 milligrams (mg) to 5 mg of the solution, broken into two daily doses. The dosage

slowly increased to 25 mg or 50 mg daily over the 12 weeks. Patients continued taking their existing medications.

Of those who started the study, 52 patients were lost to follow up and 11 stopped taking CBD before the study ended. Others were excluded from part of the analysis due to age, other health conditions or not experiencing seizures. About 37 per cent of patients had their seizures reduced by at least half. The researchers point out that 22 per cent of patients had seizures reduced by at least 70 per cent and eight per cent had their seizures reduced by at least 90 per cent.

Overall, 20 patients had severe side effects possibly related to CBD. The most common was a severe bout of seizures known as status epilepticus.

Only five participants stopped taking the solution due to side effects, however. Less severe side effects included drowsiness, diarrhoea, loss of appetite, fatigue and convulsions. Devinsky said ongoing double-blind randomised controlled trials, which are considered the gold standard of medical research, will be able to shine more light on CBD's effectiveness and which side effects are caused by the drug. Dr Kevin Chapman, of Children's Hospital Colorado in Aurora, said he'll be interested to see the results of those trials.

"From my standpoint, I don’t think it’s going to quite be the panacea we’re hoping it to be," said Chapman, who studies CBD for epilepsy but wasn't involved in the new study. For example, he said, the side effects found in the new study suggest CBD's safety is similar to that of current drugs. Also, the study suggests there may be better outcomes among people taking CBD and another popular epilepsy drug known as clobazam. "I think it raises some questions about the utility for CBD, but it lays the groundwork for future studies," Chapman said. Devinsky said his team's ongoing clinical trials of CBD should be completed around February.

Reuters

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EXPRESS PHARMA

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January 16-31, 2016

RESEARCH

Bayer forms gene editing partnership with CRISPR Therapeutics Bayer will buy a minority stake in CRISPR Therapeutics for 35 million euros BAYER WILL spend 325 million euros ($353 million) on research into a promising new gene editing technology as part of a joint venture with biotech firm CRISPR Therapeutics. Under the deal, the German drugmaker will pay for the joint venture's research over the next five years, 300 million euros in total. The venture will be 50 per cent owned by the partners.

Bayer will buy a minority stake in CRISPR Therapeutics for 35 million euros. CRISPR Therapeutics, headquartered in Basel, Switzerland, with re-

search operations based in Cambridge, Massachusetts, uses the so-called CRISPRCas9 technology, which has become the preferred method of gene editing in research labs due to its ease of use. CRISPR, which stands for clustered regularly interspaced short palindromic repeats, allows scientists to edit genes by using biological "scissors" that operate a bit like a word-processing program that can find and replace defects. The joint venture will look into ways to fix malfunctioning genes

in parts of the body that are at the origin of certain diseases, such as liver cells that fail to produce blood coagulation factors, the cause of haemophilia.

If successful, such genetic therapy could cure chronic diseases that now require life-long drug treatments. One of the challenges Bayer aims to tackle is how to bring the gene editing mechanism to the diseased cells. CRISPR Therapeutics will contribute its gene-editing technology, while Bayer will make its protein engi-

neering expertise and knowledge about diseases available.

Bayer has the option to secure exclusive rights to use the joint venture's intellectual property in the areas of blood disorders, blindness and congenital heart diseases. CRISPR Therapeutics will have the exclusive rights to any technology for human use from the collaboration beyond the three disease areas, while Bayer will retain the rights for non-human uses, such as agricultural applications.

Reuters

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RESEARCH

New blood thinner ‘antidote’to help doctors move past warfarin Xarelto and Eliquis are approved to treat patients with a type of irregular heartbeat called atrial fibrillation that significantly increases stroke risk A NEW class of blood thinners that competes with widely used warfarin should get a boost next year when an 'antidote' that can reverse the medications' effects in an emergency is expected to enter the market, according to top US heart doctors and investors. Xarelto, from Bayer and Johnson & Johnson, and Eliquis, sold by Bristol-Myers Squibb and Pfizer, were approved as safer and more convenient alternatives for preventing blood clots and strokes than warfarin.

But there was one hitch: there was no way to quickly restore normal clotting for patients in need of emergency surgery or to stop a major bleeding episode, leading many doctors to hold off on prescribing the drugs. “It may be uncommon, but they're memorable when they happen,” Dr Charles Pollack, an emergency physician at Thomas Jefferson University Hospital in Philadelphia, said of major bleeding events.

“We didn't have a specific reversal strategy for these drugs, and I think that left people feeling a bit insecure,” added Pollack, who has done clinical work on a recently approved antidote to Boehringer Ingelheim's rival blood clot preventer Pradaxa.

Small drugmaker Portola Pharmaceuticals this month applied for US approval of a drug called andexanet alfa that rapidly reverses the effect of Xarelto and Eliquis. It is expected to enter the market in 2016.

"It will make a big difference," said Dr Mariell Jessup, a cardiologist at the University of Pennsylvania Medical Center. "I have many physicians, particularly surgeons, who hate these

drugs. They're frightened of them because they've had to deal with the consequences of somebody coming in with trauma," while using the new blood thinners. The new drugs cause fewer major bleeding episodes than warfarin and do not require dietary restrictions or constant monitoring as with the decades-old medicine. But major bleeding remains the most worrisome risk of all anticoagulant therapy as it can be fatal or cause debilitating, longterm problems.

The treatments are about 70 times more expensive than pennies-a-day warfarin, according to Express Scripts Holding Co, the largest US pharmacy benefits manager. But given the superior safety and convenience, Express Scripts said in a statement that "the overall value is likely justified."

Health insurer Aetna expects approval of the Portola drug to gradually increase use of Xarelto and Eliquis, said Edmund Pezalla, Aetna's national medical director for pharmaceutical policy and strategy.

Xarelto and Eliquis are approved to treat patients with a type of irregular heartbeat called atrial fibrillation that sig-

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nificantly increases stroke risk, as well as to prevent blood clots following hip or knee replacement, and to treat deep vein thrombosis and pulmonary embolism. Paul Burton, vice president of medical affairs for Johnson & Johnson's Janssen unit, stressed Xarelto's safety but said availability of Portola's drug would enhance doctor comfort levels.

The Xarelto partnership is seeking additional approved uses, with trials underway in patients with acute coronary syndrome, and for reduction of major adverse cardiovascular events in patients with heart failure or peripheral artery disease.

Bristol and Pfizer have a direct-to-consumer television ad campaign to increase Eliquis awareness. "We believe that a reversal agent could be an important consideration for physicians when initiating Eliquis and switching appropriate patients from warfarin to Eliquis," Bristol and Pfizer said in a joint statement. Portola’s reversal drug "will certainly help sales.

Anybody who was waiting on the sidelines will not be fence-sitting anymore," said Les Funtleyder, healthcare portfolio manager for E Squared Capital Management, which holds Pfizer shares. The drug would become Portola’s first product on the market.

Cowen and Co forecast $355 million in sales by 2020 for the antidote. Portola is also developing a drug to rival Xarelto and Eliquis. Duke University's Dr Jerrold Levy predicted that all hospitals will stock the Portola antidote. "It increases the safety margin," Levy said.

Reuters

Adamas Pharmaceuticals lead drug meets late-stage study goals Patients treated with the drug showed 23 per cent reduction in dysfunctional movement at twelve weeks compared to placebo DRUGMAKER ADAMAS Pharmaceuticals' experimental treatment to reduce the side effect of a commonly prescribed Parkinson's drug met the main goal of a late-stage study.

The company said that its drug, amantadine HCl, significantly reduced dysfunctional movement, a side effect of lev-

orphan drug status from US Food and Drug Administration in April, which gives it several incentives including sevenyear marketing exclusivity.

However, amantadine HCl has been available in the market as an antiviral drug since 1968.

Minnesota-based UpsherSmith Laboratories has two oral versions of amantadine

odopa, a drug used to treat Parkinson's patients. Adamas expects to file for marketing approval of the drug next year, the company's Chief Executive Gregory Went said on a call with analysts. The company is committed to market the drug themselves on approval, he said.

Patients treated with the drug showed 23 per cent reduction in dysfunctional movement at twelve weeks compared to placebo, the company said. The drug had received

HCl approved in the market since 1987. Privately held Osmotica Pharmaceutical Corp is testing Osmolex ER, currently in a mid-stage trial, to treat the levodopa induced side effect.

Emeryville, Californiabased Adamas said it is also conducting another late-stage study to evaluate effectiveness of 340 mg dose of amantadine HCl given once daily at bedtime.

Reuters

EXPRESS PHARMA

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January 16-31, 2016

RESEARCH

Slightly elevated blood sugar linked to kidney damage risk Researchers looked for abnormal blood sugar by measuring blood glucose in fasting patients, and by measuring blood levels of haemoglobin A1c PEOPLE WHOSE blood sugar levels are in the borderline range – higher than normal, but not yet diabetic - might still have an increased risk of kidney problems, a Norwegian study suggests.

Compared to individuals with normal blood sugar, people with slightly abnormal glucose levels are more likely to have two problems associated with kidney disease – abnormal blood filtration and more of the protein albumin in the urine, the study found. The questions, said Dr Robert Cohen, an endocrinology researcher at the University of Cincinnati College of Medicine who wasn’t involved in the study, are, “What represents abnormal `enough’ blood sugar to start causing problems in the kidneys that we see with full blown diabetes, and what criteria should we be using if we want to get a head start on preventing the complications of diabetes?”

Globally, about one in nine adults have diabetes, which is often linked to obesity and aging and develops when the body can't properly use or make enough of the hormone insulin to

28 EXPRESS PHARMA January 16-31, 2016

convert sugar into energy. While the link between full-blown diabetes and chronic kidney disease is well known, doctors disagree about how much sugar in the blood might pose a risk to people without the disease. They also disagree on how to diagnose and treat patients with only mildly abnormal blood glucose levels and whether it’s reasonable to call this condition 'prediabetes.'

For the current study, Dr Toralf Melsom of the University of North Norway and colleagues assessed blood sugar and indicators of kidney damage in 1,261

people aged 50 to 62 who didn’t have diabetes.

Researchers looked for abnormal blood sugar by measuring blood glucose in fasting patients, and by measuring blood levels of haemoglobin A1c. This second test estimates average blood sugar over several months based on the percentage of hemoglobin – the protein in red blood cells that carries oxygen – that is coated with sugar. At the start of the study, 595 people had slightly abnormal blood sugar levels based on US guidelines for interpreting these test results,

which are fairly stringent. Under guidelines favoured outside the US that require more sugar in the blood before glucose levels are considered elevated, only 169 people had abnormal results. After a typical follow-up period of around five years, people with slightly abnormal blood sugar under either set of guidelines were more likely to have kidneys that were working harder to filter the blood. The condition, called hyperfiltration, is thought to contribute to kidney damage in diabetes.

Participants who had slightly abnormal baseline fasting glucose test results were also more likely to have elevated levels of albumin in the urine, indicating early kidney damage. The subset of people with slightly abnormal blood sugar under the more restrictive guidelines used outside the US were 95 per cent more likely to have high blood filtration rates and 83 per cent more likely to have excess albumin in the urine. The study only included middle-aged white people, so the results might be different in other populations, the

authors acknowledge in the American Journal of Kidney Diseases. There also isn’t consensus on the best way to define kidney filtration in studies of large populations because nephrons, the functional wasteprocessing unit in the kidney, vary by age and gender, the authors note.

While the study findings may not change clinical practice, the results highlight the need for doctors to pay attention to people with slightly elevated blood sugar, said Dr Laura Rosella, a public health researcher at the University of Toronto who wasn’t involved in the study.

These people should focus on lifestyle changes such as eating better, exercising more and losing weight, she said. “If someone adopts the necessary changes that would prevent the onset of diabetes, it is likely to protect against the progression to kidney disease as well – just like it will prevent cardiovascular disease and many cancers,” Rosella added.

Reuters

PHARMA ALLY I N T E R V I E W

‘Most of our clients are repeat customers’ Simfa Scientific Supplies is a leading supplier of quality fume hoods and laboratory furniture in the Indian market. Salil Sansare, CEO, Simfa Scientific Supplies, in an exclusive interaction with Sachin Jagdale, explains why his company's products are among the most preferred in the Indian market How do you select the fume hood and laboratory furniture manufacturers for sourcing the products?

Selection of a vendor depends mainly on the following factors: ◗ The product itself: quality, life and features ◗ Track record and capabilities of the company ◗ Price It’s again a story of fast, cheap and good attributes.

You can always pick any two.

A fast and good product cannot be cheap and that’s what Simfa is.

Simfa represents MottCanada and LaborbauGermany in the Indian sub-continent. Mott builds lab furniture as per SEFA standards while Laborbau manufactures wooden lab furniture as per European standards. We have got more than 25 large size projects in India including US Pharmacopeia, Dupont, GVK Biosciences, Laurus Labs, Vimta Labs in the last 10 years. All our customers appreciate our quality and speed. That is why we are gaining more market share in India.

What are the options available in fume hoods and lab furniture selection?

Fume hood selection depends on many factors.

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The exact application of fume hood, the reaction setup size, electrical and gas services required, whether the lab is air conditioned or not- all such points decide the type of fume hood.

Also, as a number of fume hoods are connected to a single blower, what is the diversity of usage, whether to use a scrubber, a flameproof blower to required or not, are factors to be considered while selecting a fume hood. All these depend on the customers’ operational requirements and various regulations.

With regards to lab furniture, customers have the option of fixed lab furniture, semi mobile or complete mobile systems. It all depends on the future expansion plans of the researcher. He can opt for a completely fixed system if there is no need to change the layout. But if the research work demands changes in the lab layout every two to three years, then a flexible lab furniture system is the best solution.

What would a customer choose, steel furniture or wooden furniture?

Traditionally, American MNCs prefer metal while European MNCs prefer wood. Both have their own

benefits and limitations.

Wood has extremely high chemical resistance while steel is the best material to use in case of fire hazard.

Wood furniture can be aesthetically pleasing whereas steel furniture looks more industrial, although both are very strong and have good load bearing capacities. In fact, having steel furniture with wood fronts is an option never tried in India. It can actually give the warmth of wood and strength of steel.

We help customers make this informed decision and are ready to serve them with all the options.

Mott-Canada uses ‘Sigma Barrier’ special coating which provides extra protection against aggressive chemical fumes.

Mott-Canada also manufactures the entire range in stainless steel.

Are automations like VAV and automatic sash closing systems in fume hood really useful for energy saving?

Yes, indeed. VAV is a must for an air conditioned lab. It saves your energy bill to the extent of 40 per cent and procurement cost of HVAC system by 50 per cent. So, it saves a lot of energy.

Automatic sash closing is Continued on Page 30

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PHARMA ALLY I N T E R V I E W

‘We will continue to set our bar higher’ Dr Srinubabu, CEO, OMICS International, in an interaction with Sachin Jagdale, gives an outlook about the company, its activities and plans for India

Can you explain the idea behind OMICS International?

OMICS was founded in 2007 with an idea of providing open, free and interconnected scientific research outcomes. When I was a young Ph.D. scientist at Andhra University, I personally experienced a lot of problems in accessing relevant literature from different sources. On October 9, 2007, I received the Young Scientist Award from HUPO [The Human Proteome Organization].

There I shared the problems of budding scientists in accessing relevant literature, especially from developing nations. During the meet, few other scientists who had encountered similar problems, gave me the support and cooperation to start a new open access journal in the field of proteomics. We started our first open access journal “The Journal of Proteomics & Bioinformatics” in early 2008.

In 2009, as an organisation, we have added another 10 open access journals with the support of Stanford Alumni during my post-doctorate at Stanford University. In the same year, we also started organising conferences to provide a global platform for researchers to share across their research outcomes.

Currently, we are operating with 700 open access journals and 1000 conferences across different verticals and horizontals in medical, pharma, engineering, science,

30 EXPRESS PHARMA January 16-31, 2016

technology and business. We have a a team size of over 1000 employees operating from the US, Europe, and Asia Pacific.

Annually you conduct more than 1000 conferences across the globe. It’s a huge task. How do you manage this?

You are right. Organising 1000 conferences in more than 50 countries is a huge challenge in terms of breaking the cross cultural barriers, logistics and putting the right people on board every time we need to get our feet and get the foothold as every event is like aligning head and eye.

Hosting successful events every time needs right planning, time, effort and good project management skills. We manage to execute this in perfection through our detailed plan of action and committed workforce.

In the country like India a significant percentage of brilliant researchers/ students belong to rural India. How do you recognise them and make them aware of your journals/conferences/oppo rtunities offered by you?

India currently has about 120,000 scientists, just about a tenth of the number in the US. Hailing from a rural backdrop, I personally believe that creativity and talent are evenly distributed among the population irrespective of caste, creed, religion and socio-economic status or geographical location.

OMICS International, through its corporate social

responsibility (CSR) initiative, tries to identify the 'creative pool' through Young Researchers Forum (YRF) where free seminars, symposiums and workshops are organised in many universities and rural colleges to nurture scientific rigour. We also award $1000 to colleges or faculties in meeting the students' conveniences.

We also offer special privileges to young researchers, who want to publish their research work at our international journals and attend our conferences at discounted price. Our aim is to scout and spot untapped rural students' potentials by providing a global platform to showcase their research and explore the opportunities.

What is the total number of research papers that you get from India annually?

On an average, we receive 5000 papers annually from India, which occupies seven per cent of our total papers that we receive across globally.

Indian pharma industry is generally not considered as research friendly. What is your observation?

On certain aspects, the comment holds true as Indian pharma is still blowing its trumpet in terms of only high volume generic products and lacks in serious research and innovations. Probably, the economics like high R&D cost, affordability, market scope, RoI along with low patent regimes are pulling back the giant pharma to

PHARMA ALLY concentrate more into the low hanging fruit of generics.

As compliance and regulations are becoming more stringent these days, our pharma is also transforming into end-to-end R&D, which seems optimistic.

India has a very good scientific pool in terms of human resources, however, due to lack of opportunities many of them are heading towards foreign shore.

Big pharma companies to even small start-ups are keen in attending our pharma conferences, workshops, symposiums and are willing to make partnerships with researchers and academicians to scale up their research outcomes into lifesaving products.

Tell us about the awards/recognitions received by OMICS International.

OMICS International has made a significant progress in areas of open access publications, e-books and international conferences.

Awards and recognition demonstrate our commitment to excellence.

In recent times, we have received the following accolades. Our subsidiaries ImedPub and Conference Series have bagged Healthcare Excellence Awards as Best Medical Journals Company and Best Medical Events Company for the year 2015. The award was presented by ESL Narasimhan, Governor of Telangana and Andhra Pradesh.

Our international events are recognised and appreciated by eminent personalities like ● Pat Quinn, Mayor of State of Illinois, USA for Women’s Health, Gynecology, & Obstetrics 2015

● Brian Sandoval, Mayor of

Currently, we are operating with 700 open access journals and 1000 conferences across different verticals and horizontals in medical, pharma, engineering, science etc

Nevada, USA for Food Technology 2015 ● Boris Johnson, Mayor of London for Neurology 2016 ● Kasim Reed, Mayor of Atlanta, USA for Virology 2015 ● Greg Stanton, Mayor of Phoenix for Parkinson’s 2016 Will you be increasing the number of conferences in the coming years?

Since the time of inception, we have transformed a lot.

We started with two conferences in 2008 and reached to 1000 in 2015. With the existing infrastructure and employee size, we are planning to organise 3500 conferences in 70 countries by the end of 2017.

Globally you are one of the most respected publishing hubs. You are well-known for conferences that you

organise in different parts of the world as well. What is going to be your next initiative?

We will continue to set our bar higher and make further progress to organise 3500 conferences in 70 countries across all continents by 2017.

We have recently launched online digital video library where all our conference proceedings would be shared and be accessed by the online communities freely. We are also building up global databases of 3000000 eminent researchers profiles, abstracts, articles and powerpoint presentations from medical, pharma, engineering, science, technology and business communities which would bring greater visibility to their profiles and research globally. sachin.jagdale@expressindia.com

‘Most of our clients...

Continued from Page 29 not really essential, if you are disciplined and keep the sashes closed when you are not working in the fume hood. This simple practice saves a lot of money!

As far as the quality is concerned, how will you compare laboratory equipment, fume hoods etc. manufactured overseas with those manufactured in India?

It goes without saying that the products manufactured overseas have a considerable edge in overall build quality.

The material thickness and finishes are much superior.

The hardware used is very heavy duty. All the products are third party tested as per the global standards. Also, coating quality and its chemical resistance are way above the locally manufactured products. This

All the products are third party tested as per the global standards. Also, coating quality and its chemical resistance are way above the locally manufactured products increases product life by further 10 years! So on an average if locally manufactured lab furniture will last for 10 years, the imported ones can last for 20 to 25 years.

How will you differentiate your products from those manufactured by your competitors?

Mott-Canada and LaborbauGermany products are more sturdy and heavier than most of their other counterparts’ products. Also, our Indian installation base is mostly in

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research centres where the chemical usage is very high.

Most of our clients are repeat customers. They hardly need our AMCS, although we have such a programme. I think this proves our point.

Also, one unique thing about Mott-Canada is that they are more than willing to modify their range of casework and fume hoods at a nominal cost as compared to many of our competitors who are either not willing to modify their standard product or it comes at a high cost. Same goes with

Laborbau-Germany; they work very closely with the end user to deliver products that meets their needs exactly.

How challenging is it to sell the products in a costsensitive market like India?

Of course, Indian customer is cost sensitive. Why should he not be? Companies must spend money where it matters. Good news is that Mott-Canada and LaborbauGermany are both premium imported products. But when customers prepare life cycle

cost analysis, they realise that these products have almost 50-100 per cent more lifespan than Indian products. Also, Mott and Laborbau can save running costs by 20-30 per cent every year. This makes a lot of economic sense in buying the best quality, because it lasts long and pays back.

Tell us about your aftersales services.

We have dedicated after sales service teams. We respond to customer complaints in one working day. These teams are located in Hyderabad and Mumbai.

We have also started AMC programmes for our customers who want to have preventive and breakdown maintenance of the fume hoods and lab furniture, even after the warranty period expires. sachin.jagdale@expressindia.com

EXPRESS PHARMA

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PHARMA ALLY VENDOR NEWS

Honeywell acquires research chemicals biz from Sigma-Aldrich Broadens Honeywell’s research chemicals portfolio and expands global reach HONEYWELL HAS completed the acquisition of Seelze, Germany-based laboratory research chemicals business from Sigma-Aldrich, broadening Honeywell’s offerings for high-purity solutions for drug discovery, medical diagnostic testing and other laboratory applications.

The acquisition includes

They are ◗ Fluka chemicals and reagents used for biochemical research and other chemical and pharma applications ◗ Hydranal Karl Fischer titration reagents used by laboratories to measure moisture content in liquids and solids ◗ Chromasolv high-purity solvents for chromatography, a

will continue to be led by the core leadership team of the acquired company. With two production sites, Seelze and Muskegon, Mich, in the US, the combined business unit will be able to develop and manufacture high-purity research chemicals and other materials used in new drug discovery, medical diagnostic

The acquired business employs approximately 200 people, primarily in Seelze, with sales and marketing personnel throughout Europe the Fluka-branded solvents and inorganic chemistry portfolio worldwide and the Sigma-Aldrich-branded solvents and inorganic chemistry portfolio in the European Economic Area (EEA). Those offerings are now part of Honeywell’s broader portfolio of offerings for research chemicals, which already includes the Riedel-de Haën and Burdick & Jackson brands.

“The combined Honeywell business will be able to serve a broader range of customers and applications with global brands recognised for worldclass quality and lot-to-lot consistency — essential for a range of applications including drug synthesis, food, environmental, chemical and forensic testing,” said Qamar Bhatia, President, Honeywell’s Specialty Products business.

The Honeywell portfolio now includes six product lines.

32 EXPRESS PHARMA January 16-31, 2016

technique used to separate and analyse complex mixtures ◗ Riedel-de Haën high-quality research chemicals used in pharma production and bioscience ◗ Burdick & Jackson high-purity solvents, reagents and chromatography products for laboratories and pharma production ◗ Sigma-Aldrich solvents and inorganics sold into the European Economic Area The acquired business employs approximately 200 people, primarily in Seelze, with sales and marketing personnel throughout Europe. Honeywell’s Seelze plant, which manufactures Riedel-de Haën-branded products, currently makes the majority of the products in the acquired business.

The acquired business will be integrated into Honeywell’s Fine Chemicals business and

testing and other laboratory applications.

With the addition of titration products, high-purity solvents and reagents, and specialty inorganic chemicals, Honeywell builds on an already strong portfolio of Burdick & Jackson and Riedel-de Haën products. Honeywell’s Fine Chemicals business has supplied high-quality research chemicals and specialty organic and inorganic compounds to the chemical and pharma industries for more than 100 years. Its products are sold under the Burdick & Jackson and Riedel-de Haën brands, and are used in a variety of laboratory, consumer and industrial applications including drug discovery, toothpaste, water purification, fortified foodstuffs, polymer synthesis, and metal surface treatment and finishing.

EP News Bureau-Mumbai

Multisorb’s optimal sorbent strategy can help increase efficiency and quality The company will exhibit and showcase its ability to help medical device companies increase efficiency at MD&M West in Anaheim in California MULTISORB Technologies will exhibit and showcase its ability to help medical device companies increase efficiency and improve quality through the optimal use of sorbent technology at MD&M West in Anaheim, California, February 9-11, 2016 .

"Medical device companies need to carefully consider the sorbents they use or risk downstream quality issues from poorly designed sorbents," said Chris Gilmor, Commercial Director, Multisorb's Healthcare Packaging Group in the Americas. "Multisorb's Success through Efficiency programme is designed to help companies optimise their use of sorbent technology to assure medical device stability and quality while increasing efficiencies."

Multisorb's Success through Efficiency programme offers a comprehensive approach to help companies quickly identify, select and dispense the optimal sorbent solution for market success: • Simulations for product stability and faster market access: The SimulSorb and SimulOx simulations use QbD-based modelling to quickly identify the optimal sorbent for desired shelf life. By eliminating costly sorbent ranging studies, simulations can help get the product to market six to 12 months faster.

• Sorbent platforms for all

The programme offers a comprehensive approach to help companies identify, select and dispense the optimal sorbent solution for market success requirements: The technical team can help select the best platform for your packaging presentation to deliver the lowest possible net packaging cost.

• Dispensing systems for cost effective and turnkey operations: By engineering sorbent platforms with their respective dispensers, MultiPacket and MultiCanister systems deliver maximum efficiency. The result is an industry leading output efficiency of >99.997 per cent and the lowest total cost of ownership.

EP News Bureau-Mumbai

PHARMA ALLY

Waters Corporation ZIM to expand its refrigerated container fleet signs agreement The expansion of the refrigerated container fleet will support the growing demand for ZIMonitor, ZIM's premium reefer cargo tracking service ZIM INTEGRATED Shipping Services has expanded its refrigerated container fleet in order to cater to the demand for its innovative ZIMonitor service. Launched in early 2015, ZIMonitor allows customers to track, monitor and remotely control sensitive, high-value cargo stowed in refrigerated, or reefer, containers. Customers can opt to receive alerts regarding their shipment via text message or email, closely monitor their cargo's status and intervene to prevent damages through ZIM's 24/7 dedicated global response team.

An order of approximately 1900x40-Feet High-Cube refrigerated containers is planned to be deployed during 2016. The new advanced and environment-friendly containers were specifically

designed to accommodate the ZIMonitor service and received a special prefix: ZMOU. ZIM has partnered with Teva Pharmaceutical Industries on a successful pilot of the ZIMonitor service that addressed Teva's uncompromising commitment to the

quality of its products and its dedication to meet the requirements of its customers.

Upon the successful completion of the pilot, the ZIMonitor service quickly gained popularity among ZIM's customer base.

EP News bureau-Mumbai

with BioCity To launch an open access analytical laboratory at Alderley Park WATERS CORPORATION and BioCity, the UK-based bioscience incubator company, announced an agreement to launch an open access analytical laboratory. Located in the BioHub at Alderley Park, the laboratory will offer Waters’ state-of-the-art liquid chromatography (LC), mass spectrometry (MS) and informatics technologies, along with a suite of analytical platforms to scientists working in the pharmaceutical and life science industries.

“Engaging with scientists in the BioHub at Alderley Park provides a unique opportunity to work and partner with customers, given the geographic proximity of Waters’ Wilmslow location. We expect that this close relationship will also give us deeper insight

into customer needs and challenges,” said Richard Ladd, Senior Director, Pharmaceutical Business, Waters Division.

The laboratory will be resourced with many of Waters’ latest technology offerings, including ACQUITY QDa ACQUITY H-Class, ACQUITY UPC2 and ACQUITY PDA Detector, along with the expertise required to leverage the power of these instrumentation platforms. The laboratory will also include a nuclear magnetic resonance (NMR) system provided by Manchester Science Partnerships, the owners of Alderley Park.

The Waters/BioCity laboratory is scheduled to open in early 2016.

EP News Bureau-Mumbai

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

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regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

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Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

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January 16-31, 2016

PHARMA ALLY PRODUCTS

Gandhi Automations develops technical expertise to manufacture automated rolling shutters GANDHI AUTOMATIONS, an entrance automation and loading bay equipment company, is the only manufacturer of rolling shutters certified to ISO 9001 - 2008 quality management system. This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically advanced machinery to offer to the customer a well-engineered product. Over years of meticulously working on the design, fabrica-

Rolling shutters

34 EXPRESS PHARMA January 16-31, 2016

tion and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters. The research and development team with its extensive knowhow and experience produces specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations’ manufacturing process right through installation to after sales service.

Gandhi Rolling Shutters are ideal for situations where side room is at a premium and security is required. Our

rolling shutters require very little headroom above the structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. Gandhi rolling shutters are fabricated of interlocking galvanised insulated and non-insulated, stainless steel, patented aluminum or polycarbonate profiles and patented MS rolling grills.

The rolling shutters have been designed according to the clients specifications conforming to IS 6248 and solidly constructed to promote troublefree operation and long life.

Gandhi Rolling Shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

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

Waters products manufactured as per US FDA and CEMarked standards

WATERS CORPORATION announced that the Waters Acquity UPLC I-Class IVD/Xevo TQ-S micro IVD System is now manufactured as a US FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). This development will allow clinical laboratories to access leading innovations in liquid chromatography (LC) and mass spectrometry (MS) technology for the analysis of a variety of compounds that include diagnostic indicators in laboratory-developed tests.

Using LC-MS technology, clinical laboratories perform qualitative and quantitative analyses of patients’ samples to aid clinicians in many ways. Over recent years, the scope of use of LC-MS in the clinical environment has widened and the number of tests that can be developed and validated by diagnostic laboratory service providers has grown rapidly. Liquid chromatography separates analytes and interferences within a given sample, while mass spectrometry technology is used for detection and confirmation of those ana-

lytes. The ACQUITY UPLC IClass IVD/Xevo TQ-S micro IVD System features Waters' UltraPerformance LC technology coupled with a benchtop tandemquadrupole mass spectrometer designed to provide the highest acquisition rates in UPLCMS/MS quantitative analysis.

Xccelerated Ion Transfer (XIT) electronics, using SpaceWire technology, allow this instrument to acquire data at high speeds without compromising performance, and extensions to triedand-tested StepWave ion optics continue Waters’ long history in the delivery of sensitive and robust LC-MS systems.

Contact details Dayamani Santosh Sr Admin Officer Waters India 36A, II Phase Peenya Industrial Area Bangalore 560 058 [T] 080-49292200-03 [F] 080-49292204 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@ waters.com

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

36 January 16-31, 2016

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OSMOMETER 3250

Milk Cryoscopes Available

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

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

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218, RAMGOPAL INDL. ESTT., DR. R.P. ROAD, MULUND (W), OPP. JAWAHAR CINEMA, Mumbai - 400080

Tel.: 022 - 25617972 / 9821183263 • E-mail: kannan_autofil@yahoo.com

POWDER FILLING MACHINE (load cell based)

GARNULEFIL MACHINE

OUR OTHER PRODUCTS 1. Automatic Double Head Augerfiller machine To fill dry syrup powders and similar powders.

2. Automatic Microdozer machine with bung feeding and pressing units.

To fill dry injectable powders from 100 milligrams to 3 grams. Special attachments available to fill from 25 milligrams.

3. Electronic Tablet Counting and filling machine.

Tablets & capsules of any size and shape. No change parts required.

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PHARMA LIFE I N T E R V I E W

‘The need of the hour calls out for a mindset change on how we manage employees’ Richard Cowley, Founder, WorkAmmo, in an interview with Viveka Roychowdhury, talks about the need for leadership to support a learning culture What are the top challenges facing the life-sciences talent pool in India and globally today?

In my opinion, the most critical challenge for the life-sciences talent pool is the imperative to stay current in an industry that’s constantly changing in all directions. At a more granular level, a major challenge is the ever-increasing gap between what we’re taught in university and the skills and capabilities organisations actually need as a bare minimum.

What are the top challenges facing life-sciences HR in India and globally today?

The top three critical challenges in my opinion are capability building, employee turnover and skill gaps (education).

Building capability in the lifesciences context requires a systematic approach to learning and development as an integral part of workforce planning.

Along with learning and development planning, there is a need for alignment with other workforce activities, and the need for leadership to support a learning culture.

The evolution of ‘hybrid talent,’ professionals who not only possess scientific knowledge, but also the business skills necessary to help advance products through their life cycles, is resulting in the need for

54 EXPRESS PHARMA January 16-31, 2016

a far more well-rounded learning culture, and HR is struggling to keep pace.

Another key element to building capability is the retention of key personnel, this includes employees who are senior or close to retirement.

This may also necessitate the need for a review of the norm in terms of work hours, benefits and hourly pay arrangements.

India Inc, not just the life sciences sector, also needs to get together and share a very robust communication of future anticipated needs with government and academia to help drive student education programmes and curriculum development. I believe it’s a crucial strategy for the future.

Given these challenges on both sides, how do you think the role of the human resources function within work places should evolve, given the scarcity of talent, the changing nature of business, etc? Is this happening and if not, what are the options for both sides?

I believe the challenges are essentially the same no matter which side of the pond one are on.

In India, generally speaking, HR is at a more nascent stage of the HR evolution cycle, so the challenges are starker. The need of the hour calls out for a mindset change on how we manage employees - less personnel

management and more business partnering.

All the challenges I have articulated above can be addressed by robust planning.

Poor planning leads to poor performance! As HR leaders, contributing to the preparation of the future workforce 10 years down the road, believing we are responsible now and can help will deliver this critical need.

We must definitely manage workforce demands and capability for the next three years using a global mindset and the build, borrow or buy method. We should partner with the business today to deliver people strategies that overcome this period of industry turmoil — there is no better time to step up.

Another challenge is managing cost in an era of talent scarcity. HR departments are pushed to reduce fixed costs, whilst hiring the right people on inflated pay scales, primarily owing to scarcity in specialist areas. For India, there is a need to deliver a very focused build/ borrow/ buy talent/strategic workforce plan.

One huge potential impact on research and pro-active medicine is of the ever-evolving digital world — set to drive new business models and ways of thinking, as it has done in other industries. In this regard, the belief is that it will not be tech geeks but industry specific geeks that will create the next generation of platforms. The various forms of engagement with technology will include disease prevention, monitoring, treatment and more personalised care. This may also extend through to the commercial and supply process where products will be available in models not too dissimilar to Amazon!

The HR capability in this context is clearly the challenge of merging different structures and cultures, the consolidation of which can be difficult. With so much opportunity, large demographic countries like Brazil and China are being supported by government initiatives. It will be key for

The Indian government has been doing a stellar job by initiating a number of programmes to develop relevant skills for the workplace India to move with assertion if they are to maximise the global opportunity or focus on targeted geographies. The demand therefore will be on accelerating the inventory of current people’s capability against the future need to deliver competitive advantage in the exploration of future opportunities.

With anticipated investment in the digital space, HR professionals will already be pro-actively starting to understand people needs in terms of hardware/software capability, and if they aren’t, now is as good a time as any.

What is the vision behind WorkAmmo? What is the value add?

WorkAmmo was founded to fulfill a straightforward objective: to help people achieve in the workplace. From my personal and professional experiences, I have truly come to believe that when we invest in individuals, transformation is inevitable. WorkAmmo was built to fuel this transformation.

We believe that when individuals achieve, teams, organisations and economies achieve. All our offerings are fuelled by this vision and built on this principle, and will be fundamental in solving challenges at the workplace, globally.

What are the products/services being launched next month and for which sectors?

CareerLine.com is our first offering, which was rolled out in December 2015, with a soft launch in India in October. With CareerLine.com, we hope to be instrumental in shifting the focus from jobs to careers. We believe that with the right tools

To subscribe: bpd.subscription@expressindia.com

and guidance, individuals can build successful careers they love and own. With CareerLine.com, individuals can assertively take control of their career, starting with young people aged 13, at the cusp of educational choice, all the way through to postretirees. It is a free, private space for life - a place to document an individual’s career, receive help to develop their career, and finally help deliver their career by pushing jobs to them based on their profile and preferences.

CareerLine is available on the web, as well as on Android and iOS. How is CareerLine different from recruitment sites or other career management tools?

For starters, CareerLine is a private space that only the member (CareerLiner) has ownership of. CareerLiners can document and manage their career and develop themselves, in complete privacy, at their own pace - any time, anywhere. While we do push best-fit jobs to CareerLiners, members only engage with prospective employers that they choose to engage with, and share information with them in stages. Even our personal development offerings are pushed specific to the stage of the career journey CareerLiners are in and are tuned to their career development needs at that time. WAKE, our proprietary algorithm ‘learns’ members the more specific they are with their goals and career aspirations, the more precise our content and learning resources get.

Job boards and social

recruitment sites give users a false sense of gratification because of the ‘connectivity’ and the sheer volume of listings. How many of these thousands of available jobs are actually relevant to users, though? How many are in line with users’ career aspirations?

Plus, there is no immediate feedback on where users are in the recruitment process.

CareerLine is also a great place for reflection, by plotting out their career journey, their history, present, and future goals - all in one place, it allows CareerLiners to reflect on where they have been, where they want to go and everything they need to do to get there.

What is the business model?

Where will your revenues come from?

CareerLine will always be a free service. While members may have to pay third party service providers for development resources that they sign up for, they will never have to pay to use CareerLine.

Our revenues will come from our second offering PiAmmo - which will be rolled out in early 2016. PiAmmo is a cloud-based SaaS (software as a service) workplace performance platform that will enable companies of all sizes, from SMEs to enterprise, to manage all their important people processes seamlessly. We will be launching with our recruitment module.

Why was India chosen as the launch market and which are the sectors first on your list?

My bond with India goes back many years. I have been coming to this beautiful country for 27 years now because of my regional roles in the

organisations I have worked for - British Aerospace, DHL, Kimberly Clark, managing teams and recruiting people for the various India divisions. I have come to develop a deep respect for the untapped talent in this country, and also learnt how a lot of really capable people are limited by the opportunities available to them.

While a lot has changed over the years, aspirations of the Indian workforce have kept pace. There is a clear gap that needs to be addressed. The geographical spread and hiring demand within India itself, supported by the culture where jobs versus careers is dominant lends itself to our offerings.

Employable Indians are very young, mobile demographic. A number of countries are looking for talented, educated, and motivated individuals to meet their hiring needs - fuelled by ageing populations that cannot sustain economic growth. The Indian government has been doing a stellar job by initiating a number of programmes to develop relevant skills for the workplace. If some of these initiatives cater to the specific hiring needs of other economies we will have a winner. India has the potential to be the talent export hub of the world - there is a very practical fit.

We will be targeting the IT & ITeS and life sciences sectors to start with. Both come with a unique set of needs that make the adoption of our offerings a compelling proposition.

What is your two-year strategy roadmap for WorkAmmo, in terms of future offerings, etc.?

When it comes to the workplace one can have any number of offerings, the workplace is literally our oyster.

In terms of a two-year plan, our launch in India will be followed closely by launches in Thailand and Sri Lanka by the first quarter of 2016, and in Australia, New Zealand, and other Asian countries towards the end of 2016. viveka.r@expressindia.com

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January 16-31, 2016

PHARMA LIFE APPOINTMENT

Syngene appoints Jonathan Hunt as CEO-designate Hunt will be responsible for strengthening Syngene’s relations with its existing global customers SYNGENE International has appointed Jonathan Hunt as CEO-designate. Hunt will take charge as CEO post the retirement of current CEO Peter Bains in March 2016. Bains, who has worked closely with Syngene as a Director since 2010 and was appointed as the CEO in February, 2015 will continue as a member of the Syngene Board post his retirement.

In his new role, Hunt will be responsible for strengthening Syngene’s relations with its existing global customers as well as forging new relationships. He will also steer the company’s investments in developing and strengthening its capabilities and capacities to augment Syngene’s service offerings. Prior to Syngene, Jonathan had a long standing

association with Astrazeneca where he held various leader-

ship positions including President & Director of As-

trazeneca, Austria and President and Chief Operating Officer, Astrazeneca India. Earlier in his career he worked with Bayer Schering Pharma in various capacities. He holds a BA (Business Studies & Economics) from the University of Sheffield, UK and an MBA from Durham University, UK. Commenting on the new appointment, Kiran Mazumdar Shaw, Managing Director, Syngene International said, “Hunt has a rich experience in the global biopharma industry and a proven track record of leading transformational change and delivering growth.

We are sure, under his leadership, Syngene will continue to strengthen its position in the global CRAMs market.”

Peter Bains, Chief Execu-

tive Officer, Syngene International said, “Hunt's experience in building customer-focused organisations, coupled with his leadership and operational track record, make him the ideal selection for this position and we are delighted to welcome him aboard.”

Hunt said, “I am delighted to be joining Syngene at this exciting point in its journey.

Syngene has a compelling business model, a track record of delivering operational excellence to its customers and ambitious plans for continued growth. I look forward to working closely with the Board, senior management team and leading the company to a new phase of growth.”

EP News Bureau-Mumbai

AWARD

Amrit Karmarkar receives best paper award at 2nd International Scientific e-conference The conference was organised by Texila American University (TAU) in Guyana AMRIT KARMARKAR, Director, InClinition, Mumbai, India has received the best paper award under the silver category in 2nd International Scientific econference 2015. The conference was organised by Texila American University (TAU) in Guyana.

In the conference, Karmakar presented the research paper titled 'Determination of relationship and frequency of sensorineural hearing loss in previously diagnosed diabetes

56 EXPRESS PHARMA January 16-31, 2016

He presented a research paper titled 'Determination of relationship and frequency of sensorineural hearing loss in previously diagnosed diabetes mellitus and/or hypertensive adults using qualitative semi-structured interviews'

mellitus and/or hypertensive adults using qualitative semistructured interviews.' This research was conducted in Mumbai metropolitan area. Findings of the research revealed that there exists close association with duration and control of diabetes and/or hypertension. In semi-structured interviews it was found that according to physicians, out of all sensorineural hearing loss patients, there were 71.43 per cent cases

of diabetes; 39.29 per cent cases of hypertension; and 53.57 per cent of both diabetes and hypertension. Severity of hearing loss due to diabetes and/or hypertension was found to be moderate with more prevalence in age group of 50-60 years.

EP News Bureau-Mumbai

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