Express Pharma (Vol.11, No.4) December 16-31, 2015

VOL. 11 NO. 4 PAGES 80

www.expresspharmaonline.com

Market ‘Caripill contains scientifically standardised dose of the papaya leaf extract’

16-31 DECEMBER 2015,` 40

CONTENTS MARKET Vol.11 No.4 DECEMBER 16-31, 2015 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

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‘CARIPILL CONTAINS SCIENTIFICALLY STANDARDISED DOSE OF THE PAPAYA LEAF EXTRACT’

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CPHI INDIA PRE-CONNECT CONGRESS HELD IN MUMBAI

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CONFERENCE ON ‘DRUG DISCOVERY AND DEVELOPMENT: GLOBAL SCENARIO —INDIAN PROSPECTIVE’ HELD AT NIPER

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MESSE FRANKFURT INDIA’S CONFERENCE ADDRESSES COUNTERFEITING CONCERNS IN PHARMA SECTOR

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PHARMA STALWARTS TO GATHER AT 67TH IPC

Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka

Industry leaders, analysts and opinion makers contribute their thoughts on important topics which will impact patients, the pharmacy profession and pharmacists to achieve the goal of ‘Healthy India - Swasth Bharat’by 2020 | P26

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 Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P34: INSIGHT Community pharmacists: Need of the hour

RESEARCH

P42: VENDOR NEWS Waters ionKey/MS System bags R&D 100 Award

P47: PROFILES The UEC: Leaders in pharma packaging machinery manufacturing since 1963

P75: INTERVIEW

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WE ARE WORKING ON A STRATEGY TO COVER EMERGING STRAINS BY THE BROADLY PROTECTIVE VACCINE

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US FDA APPROVES LILLY’S LUNG CANCER DRUG

‘Make in India’ initiative could be huge re-branding opportunity

P76: APPOINTMENT TAKE Solutions names Raman Kapur as Independent Director

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. 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 © 2015. The Indian Express (P) Ltd. All rights reserved throughout the world.

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EDITOR’S NOTE

Of laws and flaws

C

ould New Jersey Superior Court's decision this October be a wake up call for Indian companies with global ambitions? Deliberating on a December 2013 breach of contract lawsuit filed by US-based FDASmart, the NJ Superior Court ruled that mid cap Dishman Pharma is 'not immune to subject to NJ state jurisdiction' as its US subsidiary is an ‘alter-ego’ of its Indian parent.

In a 12-page decision, the NJ Superior Court supports its ‘piercing of corporate veil’ opinion to deny Dishman’s motion citing several instances where key CXO level positions were manned by the same people in the Indian parent and US subsidiary.

New York-based consultancy firm FDASmart signed an MoU/contract with Dishman Group, as in 2012 the Group had decided to sell its API facility in the Shanghai Chemical Industry Park. The FDASmart lawsuit claims that Dishman Group breached that contract by failing to pay for services rendered and by frustrating continuance of FDASmart’s efforts to sell the facility and collect sale success fee, according to a release from FDASmart. The MOU/contract for the sale of the Chinese plant was signed by FDASmart CEO Ram Balani and Dishman Group’s Managing Director and Chairman, Janmejay ('Jay') Vyas who is also President and sole Board Director of Dishman US. FDASmart has demanded a trial by jury for damages including $900,000 in lost commission, $40,000 in unpaid fees plus other costs totaling to $1 million. When contacted for a comment, Vyas said it was “an extremely small matter" and declined to answer queries on Dishman's future course of action.

The `2400-crore (approx $360 million) Ahmedabad-based company ultimately decided not to sell its Chinese API facility even though it was a drain on its balance sheet as approvals were taking a longer than estimated time. According to recent reports, the Shanghai facility only broke even in FY 15.

But the promoter’s patience seems to be finally paying off. Vyas recently announced that they would soon start importing intermediates from the Shanghai facility, which would be substantially cheaper than other sources. This would give a cost-competitive edge to Dishman, allowing it to supply cheaper APIs for export as well as

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In a 12-page decision, the NJ Superior Court supports its ‘piercing of corporate veil’ opinion to deny Dishman’s motion citing several instances where key CXO level positions were manned by the same people in the Indian parent and US subsidiary

domestic clients.

The NJ Superior Court’s October decision is by no means the final decision on this matter as Dishman is sure to appeal and stick to its contention that the matter has to be settled in India as FDASmart also has offices in India.

Whether the final judgement goes in favour of FDASmart or Dishman, could this court opinion have larger repercussions? Could companies brush off responsibility for actions taken by subsidiaries in overseas locations, even if the same decision makers are part of its parent company's management and in the case of Dishman, part of the promoter group itself?

Could the arm of the law reach out across continents to hold the parent company itself responsible? Where does the liability lie?

Legal eagles point out that corporate law allows a mirror image between head office and overseas subsidiaries' management boards. Legal sources felt that the FDASmart-Dishman case would not impact current practices as such cases are decided on a case-by-case basis. None could speak on record citing internal conflicts as they represent pharma companies but felt that courts seldom use the 'piercing of corporate veil' argument. This argument is reserved for extremely rare cases when the regulator is of the view that the listed entity maybe be guilty of fraud or such financial dealings that could impact shareholders’ value and always respect the legal entity represented by a listed company’s corporate structure.

The law does seem to put the corporate over the shareholder, giving the benefit of doubt to the company. For instance, in India, Clause 36 of the Equity Listing Agreement requires a listed company to inform the stock exchange of disputes, litigation, etc if the outcome could impact present or future operations or it profitability or financials. Vyas' reaction is an indication that the FDASmart litigation does not fall into this category. So is the NJ Superior Court's decision a sign of a more vigilant judiciary in the US as it involves a US taxpayer, FDA Smart? This could turn out to be an interesting case after all.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘Caripill contains scientifically standardised dose of the papaya leaf extract’ Bengaluru-based Micro Labs recently launched Caripill which helps to increase the platelet count in patients suffering from dengue. Micro Labs further claims that it has received approval by the scientific and regulatory authority from India. Dr Nagabhushan K, VP-Medical Services Micro Labs in an interaction with Raelene Kambli explains the uses and benefits of this pill

What makes Caripill useful in fighting dengue?

For patients suffering from dengue, lowering of blood platelets is a major concern which can lead to hospitalisation and in rare cases even death. Caripill’, a product of botanical origin is made from carica papaya leaf extracts, helps to increase blood platelet count. Caripill contains scientifically standardised dose of the papaya leaf extract. Patients used to consume the carica papaya juice orally with no defined dosage as there was no proper research or documentation on the same.

The extract is taken from non-standardised and unhygienic papaya leaves and no clear specified dosage.

This could have a detrimental impact on the patients.

Keeping all these factors in mind Caripill, which is a plant-based medicine manufactured by using carica papaya leaf extract, was launched to fight dengue.

Caripill has also received positive feedback from doctors treating patients with dengue.

Why did you think of an

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Ayurvedic solution to this disease?

Till the advent of Caripill, the treatment of dengue was only symptomatic. Paracetamol (Dolo650) and rehydration with continuous monitoring of the platelet levels were the only modality in vogue. When dengue progresses to the dangerous level of Haemorrhagic fever, the only option is hospitalisation and platelet infusion. The high cost and the complications involved as well as the panic associated with the imminent death were the problems to be dealt by the patients and the doctors alike.

In this scenario, the benefit papaya leaves’ juice in its crude form was a common knowledge and was being adopted with success.

However, the problem associated with the crude form – availability of leaves, uncertainty of dosage, frequency and duration of therapy and patient compliance were the problems involved in this form of treatment.

This prompted us to look into the possibility of bringing Carica Papaya in a modern dosage form, backed

with scientific validation of its dosage schedule.

What is Micro labs’ roll out strategy for Caripill?

Present the product with scientific back up, develop and disseminate wealth of data to the treating physicians, through CME (Continuous Medical Education), continue the clinical trial in large no of patients to generate more data on efficacy and safety, conduct post marketing surveillance to be on guard for the safety of the medicine.

We are constantly evaluating the demand and our manufacturer has been very consistent in supply

What is the projected demand for the pill?

The rise in the number of dengue cases this year, has created a huge demand of the product already. We are well aware of the fact that dengue is an epidemic and does not last throughout the year.

Where does your production capabilities stand at the moment?

At present, we are getting the product manufactured through contract manufacturing. We are constantly evaluating the demand and our

manufacturer has been very consistent in supply.

Is it available over the counter? How have you priced it? Is it affordable to the people at the bottom of the pyramid?

Caripill is available at `25per tablet with the dosage of administering one pill (1,100 mg) three times a day, for five days. Thus reducing the financial burden and the emotional trauma experienced by the sufferers and their families. Caripill has been made available in all major pharmacies by a team of 500 spread across the country.

What will be your next plan of action?

We would like to firmly establish the brand Caripill in the minds of our target audience in dengue induced Thrombocytopenia. We have also extended the benefits of Caripill to the paediatric patients, by launching Caripill Syrup, which has again been backed with a scientific pilot study on paediatric patients and a vigorous formulation research. raelene.kambli@expressindia.com

POST EVENTS

CPhI India Pre-Connect Congress held in Mumbai Experts discuss the current trends in pharma industry at the event Sanjiv Das and Usha Sharma Mumbai THE CPhI India Pre-Connect Congress, recently held in Mumbai, saw leading pharma experts discuss and provide unique insights on inorganic growth strategies, bridging gaps between regulatory authorities, transfer pricing concerns, the state of data integrity and the scope for biosimilars in the Indian market. The event started of with a welcome address by Rutger Oudejans, Brand Director, Pharma Portfolio, UBM EMEA. Oudejans said that this year’s CPhI event is going to witness participation of 32,000 visitors from over 100 countries.

Dr Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals, in his opening remarks, spoke about how the Indian pharma industry have raised its standards on the domestic as well as the global front.

In a plenary session, Alagu Subramaniam, Country Manager and Director, West Pharma, talked about the trends in the injectables and particulates market in India.

This was followed by a session on India’s growing contribution to global pharma

by Jim Tizzard, Chief Executive Officer, TAKE Life Sciences.

Tizzard spoke about India’s contribution to the global pharma sector, the emerging Indian market, role of partners in the pharma industry, challenges in pricing strategies and accelerating growth in generics.

A series of panel discussions were held during the Congress.

The first panel discussion on ‘M&A: Strategic deal-making for growing alliances and gaining a competitive advantage in emerging markets’ was moderated by Ajay Joseph, Partner, Lakshmikumaran and Sridha-

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MARKET ran Attorneys. The panelists were Sudhanshu Priyadarshi, Global COO, Cipla; Sanjiv Navangul, Managing Director, Janssen India and Sanjay Singh, Partner, Deal Advisory M&A, KPMG India.

Singh elaborated on how India has emerged significantly and has been able to acquire foreign assets. He said that initially the trend was one-way where foreign companies used to acquire Indian companies.

Now, the scenario has changed where domestic firms are eager to merge with their global counterparts.

Priyadarshi said that a lot of M&A activities are happening currently. Pharma companies are looking to diversify geographically. He talked about how Cipla has been able to enter the Japan and Russian markets.

Navangul spoke on the changing M&A scenario globally. So, companies need to ensure how to become competitive with cutting-edge technology. M&As will eventually help to plug-in certain gaps and assist in sustainable growth. He also mentioned that in India, stress is more on development than research activities.

The second panel discussion on ‘Bridging gaps between regulators across the world and creating synergies for the enhancement and reach of drugs’ was moderated by Akun Sabharwal, Director Controller of Drugs, Government of Telangana. The panelists were Daara Patel, Secretary General, IDMA; Dr Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals; Abha Pant, President R&D (Formulations), Ipca Laboratories and D Roy, Former Deputy Drug Controller (India) Central Drugs Control organisation (CDSCO), Ministry of Health, Government of India.

Lamba stressed upon the need to upgrade regulatory mechanisms and streamline the inspection process. Pant said that there is a need for a single approval system rather different ones at the Centre and the state. Pant further said, “Today, the problem faced by the industry is not with the quality but the process.”

A brief speech on ‘Digital platform for pharma and

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Delegates at the event

healthcare products for digital India’ was given by Bhavik Kumar, Co-founder and Director, Medibox Technologies where he talked about the right time to market new products.

The next panel discussion was on ‘Navigating the transition of India from a manufacturing hub to a global pharmaceutical innovation and drug discovery destination.’

The panel was moderated

by Utkarsh Palnitkar and the panelists were Ranjana Smetacek, Director General, OPPI; Dhileep Krishnamurthy, Vice President and Global Head-R&D, Piramal; Sudarshan Jain, Managing Director, Healthcare Solutions, Abbott Healthcare and Sharad Tyagi, Managing Director, Boehringer Ingelheim.

Jain stressed on the need to create the right kind of ecosystem for growth. Krishnamurthy said, “We need to focus on technology, development and research.” He also said that there should be an initiative to reverse brain drain as many from our country are working abroad.

Smetacek said that time is opportune and obstacles need to be removed in order to improve the overall scenario and the ecosystem. She talked about the initiatives by CSIR Chandigarh and Sree Chitra Tirunal Institute for Medical Sciences and Technology.

The next panel discussion was on ‘Combating transfer pricing misery for pharmaceutical industry’. The panelists were Ramesh Swaminathan,

CFO and President, Lupin, Simachal Mohanty, Senior Director — Taxation, Dr Reddy’s Laboratories; Giri Giridhar, Senior Director— Finance and Member of the India Board, Merck Sharpe and Dohme and Shilpa Udeshi, Director-Transfer Pricing, PwC. Mohanty said, “Although transfer pricing principles are same, domestic implementations have issues.” However, he also added that a lot of engagement is happening from the government’s side.”

A panel discussion on ‘Assessing the potential gaps and analysing the state of data integrity compliance in Indian pharmaceutical industry’ was moderated by Vinay Nayak, Director, Surge Chemicals and the panelists were Vinod

Kumar Kansal, President R&D, Teva Pharmaceuticals, Govind Srinivasan, Vice PresidentTechnology Services Group, TAKE Solutions, Rashida Nazmi, Vice President- Corporate Quality, Piramal Healthcare and Subramanyam S, Director, Infionic.

An awards ceremony was also held. Under the nomination-based category, the awards went to Accutest Research Laboratories India for Excellence in Contract Research; Sun Pharmaceuticals Industries for Excellence in Corporate Social Responsibility; Zydus Takeda Healthcare and Cadila Helathcare for Excellence in Environment, Health & Safety; Zydus Cadila Healthcare for Excellence in Packaging; Image Provision Technology for Excellence in Pharmaceutical Machinery/Instrument; Piramal Enterprises for Excellence in Supply Chain & Logistics Management; Eisai Pharmaceuticals India and Abbott Healthcare for Operational Excellence; Cipla for Excellence in Rural Reach; Bharat Biotech International and Shilpa Medicare for Excellence in R&D; Cipla for Excellence in Brand/Product.

Under the Jury’s Choice Awards, Vinita Gupta from Lupin received Personality of the year — Female, Mehul Shah from Encube Ethicals was Emerging Entrepreneur of the Year, NH Israni from Blue Cross Labs got the Inspirational Leader award and Samprada Singh from Alkem Laboratories received the Lifetime Achievement award.

UBM Initiative Awards went to Globela Pharma as Emerging Exporter of the Year; Nitika Pharmaceutical Specialities as Leading Excipient Company; GMP Technical Solutions as Leading Clean Room Projects & Solutions; West Pharmaceutical Packaging India as Outstanding Primary Packaging for Injectibles; Linux Laboratories as Outstanding Customer Service; Thermolab Scientific Equipments as Leader in Stability Chamber and Medibox as Technology Start-up Award.

Sanjiv.das@expressindia.com u.sharma@expressindia.com

MARKET

Conference on ‘Drug Discovery and Development: Global Scenario —Indian Prospective’held at NIPER Discussions were held on how innovations in modern era enabled the discovery of new drugs with better efficacy and safety profile A CONFERENCE on ‘Drug Discovery and Development: Global Scenario —Indian Prospective’ was recently held at National Institute of Pharmaceutical Education and Research (NIPER) Hyderabad.

Dr Ahmed Kamal, Project Di-

rector, NIPER-Hyderabad delivered the opening remarks.

Kamal discussed the importance of drug discovery to the mankind in treating several complex diseases. In his speech, he focused on how innovations in modern era en-

abled the discovery of new drugs with better efficacy and safety profile and the challenges faced by the researchers involved in the discovery process today.

Kamal gave a brief note on initiations by the Department

of Pharmaceuticals to forge several collaborations recently between NIPER and several pharma industries to promote industry-academia linkages and strengthen drug discovery and development efforts. He also mentioned that as part of

this process, a number of MoUs were recently exchanged in the presence of Pranab Mukherjee, President, India. Kamal also added a note on the progress made by NIPER-Hyderabad in the last few years and assured that it will take a leap further to

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MARKET meet the future demands of the pharmaceutical Industry.

Dr S Chandrasekhar, Director, IICT briefed about the drug discovery research happening at IICT. He motivated the students by saying young minds (students) should become entrepreneurs creating opportunities rather than looking for opportunities and take forward their research.

Dr VK Subburaj, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India, mentioned that there is a need to produce quality medicine at affordable cost and to increase the quality of life. He also indicated that it is high time that the academic institutes start research work especially in drug discovery aspects individually or in collaboration with industries.

The key note address was given by Dr AV Rama Rao, Chairman and Managing Director, AVRA Laboratories. He started with initial era of drug discovery and development how it began from extraction of actives from natural sources and discussed how drug discovery has progressed over the years with examples. Later, he also mentioned the Indian scenario in drug discovery.

A scientific programme was held which included plenary lectures, oral presentations

(L-R) Dr Ahmed Kamal, Project Director, NIPER-Hyderabad, Dr AV Rama Rao, Chairman and Managing Director, AVRA Laboratories, Dr VK Subburaj, IAS, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers; Government of India and Dr S Chandrasekhar, Director, IICT

A scientific programme was held which included plenary lectures, oral presentations and poster presentation sessions and poster presentation sessions specially covering the topics on advances in disease biology: newer approaches; natural products as leads in drug discovery; rational drug

design/fragment based libraries; development of new synthetic strategies; drug delivery advances: nano technologies/formulations; preclinical drug development; transla-

tional research (preclinical to clinical); new therapeutics: antibody-drug conjugates.

The scientific lectures were delivered in three sessions. The first session by Dr Ramesh

Panchagnula, Vice President & Head: Nektar Therapeutics (India), Hyderabad gave an overview of drug development process in the industry with relevant case studies.

The second lecture was by Prof Javed Iqbal, who delivered talks about targets in diabetes mellitus and other metabolic disorders. Dr Ian Cliffe, Vice President and Head: Research Management, Daiichi Sankyo India Pharma, discussed about identification of chemical leads in pharma industry and described the story behind the successful approval of a novel structural compound using virtual library screening approach against obesity.

Post lunch session started with the lecture of Dr Mukul R Jain, Senior Vice PresidentPharmacology, Zydus Research Centre, Ahmedabad followed by Dr AKS Bhujanga Rao President: Natco Research Centre, Hyderabad and Dr Murali Ramachandra, Senior Vice President, Aurigene Discovery Technologies, Bangalore. The last session ended up with lectures from Prof Pratipal Singh, Professor in Pharmacology: NIPER SAS Nagar and Dr Brian W Dymock, Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore.

EP News Bureau-Mumbai

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

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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.

Preferably in colour, postcard size and with a good contrast.

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MARKET

Messe Frankfurt India’s conference addresses counterfeiting concerns in pharma sector Experts discuss strategies and identify solutions to curb the $4.25 billion fake drugs market MESSE FRANKFURT Trade Fairs India recently organised a conference on anti-counterfeiting and brand protection Pharmasafe India in Mumbai .

The-two day conference focused on best practices to combat counterfeiting challenge in the pharma sector brought together 144 attendees including 21 eminent speakers representing entire cross section of the industry to discuss strategies and identify solutions to curb the $4.25 billion fake drugs market.

Business leaders and key decision makers from top pharma companies, anti-counterfeiting technology experts and solution providers, customs, government and regulatory authorities and leading industry bodies such as Organization of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers Association (IDMA), Indian Pharmaceutical Association (IPA), Federation of Pharma Entrepreneurs (FOPE) as well as speakers from Sanofi, ACG Worldwide, Abbott Healthcare, Boehringer Ingelheim, Central Drug Standards Control Organization, HP Indigo and Inkjet Solutions among others, became the common voice of the industry.

Ajit Singh, Chairman, ACG Worldwide said, “Counterfeiting is largely invisible and therefore not much attention has been given to this issue.

Pharmasafe India has turned out to be one of the best platforms in the industry. We feel this is an excellent initiative that Messe Frankfurt has Undertaken. It aligns with our objective and would love to be part of it again next year.”

Dr Shailesh Iyenger, MD, India & VP, South Asia, Sanofi said, “The initiative and purpose behind this first-ofits-kind forum for the sector is

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MARKET truly commendable. The discussions here are need of the hour and it is time the industry and other key stake holders came together to address the serious challenge of counterfeiting of pharmaceuticals.”

On the second day of the conference, Pramod Bhatt, Director- Security and Intelligence, Sanofi spoke on the need for creating consumer awareness to curb counterfeit medicines and deliver safe medicines to the consumers.

He stressed on creating an external platform which will be help to generate better awareness. He suggested that it should be a public-private partnership between police officials, CBI officials, customs officers and drug regulatory authorities. He also suggested creating a campaign at school level, medical colleges etc and collaborate with the Ministry of Consumer Affairs for a nationwide campaign.

Rajiv Joshi, Partner, Fraud Investigation and Dispute Services Ernst and Young, talked about the good initiatives being taken by the gov-

Delegates at the event

ernment such as Jaago Grahaak Jaago and its relevance in today's time. He also spoke on the Whistle Blowers Pro-

tection Act, 2011 and its use in the Indian pharma industry.

He also said that it has found acclaim globally. He also

opined that the Indian pharma industry is highly regulated and it is mandatory for all the stakeholders to

know about the legalities related to the sector.

Ajay Chandru, Senior Member of the Intellectual Property (IP), Pharma and Life Science Practice, Nishith Desai Associates, shared his domain knowledge and spoke on the laws affecting the pharma industry. While discussing about the counterfeit issues, he informed the stakeholders about the procedures required for appealing in the court and what support a plaintiff can get in order to ensure that the products are genuine.

Bharat Kapoor, Chief Operating Officer, Strategic IP Information informed that there are around 1300 online domains which have been banned for supplying illegal or fake medicines. Today, around 30000 products are sold online, which are mainly for weight loss, in the cosmetics category etc.

Ameesh Masurekar, Director, AIOCD Pharmasofttech AWACS said that brand protection is a key element in any organisation.

(With inputs from Usha Sharma)

PRE EVENT

Pharma stalwarts to gather at 67 IPC th

67th IPC will be held in Mysuru between January 19 and 21, 2016 THE 67TH Indian Pharmaceutical Congress (IPC) at JSS University Campus, between January 19 and 21, 2016, to be held in Mysuru, will see more than 10,000 national and international delegates. Organised by the Indian Pharmaceutical Congress Association, the theme for this year’s convention is ‘Healthy IndiaSwasth Bharat’.

The three-day event will cover various issues related to the industry, academia and community pharmacy. The congress will be inaugurated by Siddaramaiah, Chief Minister,

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The three-day event will cover various issues related to the industry, academia and community pharmacy Karnataka.

Sponsored by industry stalwarts GlaxoSmithKline, Indegene and Meopharm amongst other renowned pharmaceutical brands, the event will see the likes of Dr Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon; Dr Pankaj Patel, Chairman and

Managing Director, Cadila Healthcare and Dilip Surana, Managing Director, Micro Labs, providing insights into the industry.

The American Medical Association along with the drug regulators from all the SAARC Countries and the Drug Controllers of India will grace the

occasion.

The congress will see participation from Dr C Subhuraj, Secretary, Ministry of Chemicals & Fertilizers, Government of India, KL Sharma, Joint Secretary, MoHFW, Government of India, Pankaj Patel, Chairman and Managing Director, Zydus Cadila, and

many more.

A platform for exchange of knowledge, the congress will have intellectuals from the relevant branches of pharmacy from all over the globe. Pharmaceutical Expo – 2015 Exhibition will be held simultaneously. An initiative by Exponext, the exhibition will showcase all the latest technological developments, upgradation and adaptation in the pharma industry through a stellar display of equipment, instruments and utilities.

EP News Bureau-Mumbai

EVENT BRIEF JANUARY 2016 - APRIL 2016 7

National Conference on Drug Discovery & Therapy

NATIONAL CONFERENCE ON DRUG DISCOVERY & THERAPY Date: January 7-8, 2016 Venue: Department of Biochemistry and Biotechnology, Annamalai University Summary: Department of Biochemistry and Biotechnology, Annamalai University will organise National Conference on Drug Discovery & Therapy (DDT-2016).

Contact details Dr N Rajendra Prasad, Assistant Professor, Dept of Biochemistry & Biotechnology,Annamalai University, Annamalainagar 608 002 Tamil Nadu Tel: + 91 4144 – 238343

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India Pharma 2016

Fax: +91 4144 – 239141 Mob: + 91 9842305384 Email: drprasadnr@ gmail.com

INDIA PHARMA 2016 Date: January 7-9, 2016 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India with FICCI will provide a platform to global investment community to connect with stakeholders in the pharmaceutical sector in India, central and state governments, leading business leaders and top

To subscribe: bpd.subscription@expressindia.com

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Asia Pharma Expo 2016

executives from the industry, academics and experts from the world.

Contact details BK Nayak, Senior Assistant Director, FICCIT/ F: 080 22861949 Mob: 91 9945790735 email:nayak.bk@ficci.com

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 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

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,

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PHARMA Pro&Pack Expo 2016

capsule, injectable, ointment, 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

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cover )

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December 16-31, 2015

AYUSH SPECIAL

(

THE MAIN FOCUS

JIVAAYURVEDA taking

AYURVEDA to the

WORLD Will Director Dr Partap Chauhan’s focus on the global market and other forays like ayurvedic telemedicine succeed in achieving revenue of ` 75 crores this year?

BY USHA SHARMA

N

early 30 km away from Indian capital city, Jiva Ayurveda, located in Faridabad near New Delhi, was founded with the mission of ‘taking Ayurveda to every home.’ Its main centre in Faridabad is well equipped to provide a range of Ayurvedic treatments to help people stay

healthy and seek a permanent and effective cure against diseases. The name ‘Jiva’ itself explains its existence and the company’s core objectives.

Replying to why the founders decided to call the company ‘Jiva’, Dr Partap Chauhan, Director, Jiva Ayurveda, an Ayurvedic doctor with an unique distinc-

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tion of studying Ayurveda through the modern system of university education and the traditional system of a guru-shishya parampara briefs, “The name Jiva comes from the Sanskrit word Jiv which means life or living entity. Jiva is dedicated to the cause of humanity and so the name was chosen.” He had a

keen desire to establish the authentic practice of Ayurveda and to make it affordable and accessible to bring it to every home around the world.

History at a glance In early 1982, the concept of starting Ayurveda clinics was conceptualised when Rishi Pal

Chauhan, the present Chairman and Managing Director of Jiva, realised that the society was moving in a new direction and needed some traditional medicine blended with modern technology. At that point of time, he was unaware on how to action it further. Later, he himself along with his two brothers, Dr Satya-

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cover ) Jiva is dedicated to the cause of humanity and so the name was chosen Dr Partap Chauhan, Director, Jiva Ayurveda

We need to work together with the international scientific and medical community to conduct more researches in Ayurveda and its fundamental principles Rishi Pal Chauhan Chairman and Managing Director of Jiva

Jiva aims to open 100 Ayurvedic clinics and treatment centres across India in various towns and cities Madhusudan Chauhan Director Business Development, Jiva Ayurveda

20 EXPRESS PHARMA December 16-31, 2015

narayan Dasa and Dr Partap Chauhan, who always believed that traditional Indian arts and sciences can help people live more balanced and holistic lives, decided to set up a company. The concept got a boost when his younger brother Dr Satyanarayan Dasa, an M Tech. from IIT Delhi, visited the US around the same time to pursue a professional career.

He realised that the west may have become an economic superpower but the society is still suffering from emotional and spiritual distress. He returned back to India in 1983 to gain a deeper understanding of life. In 1992, the family decided to set up its own Ayurvedic centre in Faridabad and started working from their residence.

Rishi Pal Chauhan’s vision and mission to create a healthy life lead both his brothers to move in that direction. Recalling erstwhile days, Rishi Pal narrates, “Steven Rudolph, an American educationalist and a founder-director of Jiva, met me while he was working in the US. He got inspired by the idea and the vision of Jiva and dedicated himself to the cause. He wanted to create a holistic and value-drive education system that enabled children to not only excel academically, but also provide important tools of life and values to live a happier, and thus joined the company.”

In 1994, Jiva established to work in three areas: Education, Health and Culture. The common thread that connected all three areas was to create a society that was happier, healthier and peaceful.

While explaining the need for Ayurveda clinics, he says, “While the advancements in economy and technology have led to the improvement of physical comforts, it has also resulted in problems in other areas. So by bringing together the knowledge of holistic living and well-being from the east and the advancements and technologies from the west, a great balance can be reached.

And to fulfil this, the founders of Jiva created an organisation which helped people in achieving this balance.”

proof to the globe. Suggesting to make the world more confident and reliable to the Indian origin Ayurveda medicines, Dr Partap Chauhan says, “The entire world is increasingly becoming more interested in Ayurveda. The more we are able to explain and show documented evidence of Ayurveda, the more acceptability and credibility increases .”

Threat from western world

Need of Ayurveda Today, the world has recognised the need and urgency of alternate medicines. Ayurveda is considered as the most holistic health system in the world.

It not only deals with the physical well-being, but also concerned with mental and emotional well being. Ancient Ayurvedic texts mention its objective as curing people who suffer from diseases.

Commenting on Jiva’s expertise and practising Ayurveda against other methods of treatment, Dr Partap Chauhan says, “With modernisation and the increased pace of life, our habits are changing.

Since Ayurveda offers a holistic life solution, it is better suited to help tackle the problems we face today and resolve them from the root rather than providing superficial and symptomatic relief only. By bringing Ayurveda to every

home, the goal of creating a healthier, happier society can be reached. That was the reason for practising Ayurveda.”

He further says, “When we started out, Ayurveda was not the choice of treatment and in most cases the last resort. Jiva has created a lot of awareness to help people understand the science behind Ayurveda, to demystify the principles of Ayurveda. This has helped tremendously in increasing the faith and credibility that people place in it. Lately, people have started realising that a more holistic, natural and Ayurvedic approach is a must if health in its true sense needs to be maintained. We will continue our efforts so Ayurveda becomes the treatment of choice for diseases in which it shows remarkable relief.”

Though, Ayurveda is the oldest method of treatment , it has been laggard in presenting

It is ironic that the western world is eager to gain the knowledge of Ayurveda and patent it.

Commenting on the foreseeing challenge, Rishi Pal Chauhan says, “Anyone is welcome to learn Ayurveda and apply it in their markets. There is no question of competition in that sense. It does not help to restrict knowledge. However, what needs to be done is to protect knowledge of Ayurveda being distorted or being used without crediting Ayurveda with it. There was a huge concern with some international companies/organisations trying to patent the ingredients that Ayurveda has used for centuries.”

Finding out the solution, he suggests, “We need to work together with the international scientific and medical community to conduct more researches in Ayurveda and its fundamental principles. There needs to be a collaborative approach where common terminologies and equivalents can be

AYUSH SPECIAL

arrived at to explain Ayurveda to the modern world. Integration is going to be the key in future, but for it to happen, people from both fields of sciences need to understand the modern medical science as well as Ayurveda.”

While sharing the success, he says, “The government has undertaken the Traditional Knowledge Digital Library (TKDL) project and today it’s used successfully to defend the traditional knowledge systems of India without limiting the usage of them. I think this is a great example where the government has worked with bodies and governments internationally to protect ayurvedic knowledge without limiting its use.”

on the need to conduct more research and setting up institutions of excellence that will un-

dertake such research.”

Realising the need for research and collaborate, Jiva has

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already put a lot of emphasis on research in the coming years.

“We are investing more and

more in research with a view to create a considerable ground work on which path-breaking re-

Encouraging research In earlier days, individual vaidyas used to perform the role of doctors and the need for research was not the primary concern. This led to very limited data and eco-system available for conducting such research.

That has been one of the reasons why Jiva has also followed sound data and documentation practices, enabling to power various analytical and research-based projects. With passing time, people became more inclined to technologies and started opting for modern treatment methods over the traditional ones. It eventually resulted in less research being conducted in the Ayurveda.

Commenting on why there has been less research in Ayurveda, Dr Partap Chauhan says, “There are multiple reasons for limited research in Ayurveda, the foremost being not much efforts to mainstream of Ayurveda as a credible treatment science with the scientific community and lack of infrastructure and resources at Ayurvedic colleges and universities to conduct such research.”

He suggests, “To uplift the industry in future, a strong emphasis should be given to practical research at all colleges and universities in Ayurveda. Research institutes and industry should come together so that relevant information sharing can take place. The government wants to put a special emphasis

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KEY MILESTONES

cover ) 1995

1996

1997

2006

2007

Established the world’s first Ayurvedic health centre on the Internet, which received more than 5000 visitors daily

The world’s first Ayurvedic correspondence courses being run via the Internet.

Interactions take place through the World Wide Web, Internet relay chat, and e-mail.

Students including doctors, nurses and Ayurveda enthusiasts take courses from countries such as France,Japan, Sweden, Denmark, Latvia, Switzerland, Spain and Estonia

World Summit Award for ‘TeleDoc’project given by United Nations in Geneva

Conducted world’s first Ayurvedic video conference at VSNL Studio in New Delhi at the University of Gavle, Sweden to preach its students about Vedic Sciences and Culture

Ayurvedic tele-medicine centre in Faridabad was started catering to the problems of thousands of people nationally and internationally

search in Ayurveda can be based. We are following a twopronged approach for our research projects — one that will enable us to showcase the treatment methodologies and protocols in Ayurveda and the other that will be validate the fundamental principles and concepts of Ayurveda. Both are being undertaken by the Jiva Research wing headed by a top team of scientific researchers, data scientists and ayurvedic physicians,” informs Dr Partap Chauhan.

Jiva’s USP At Jiva Ayurveda, during consultation each doctor tries to go to the root cause of the problem and prepares a customised prescription. The company is known for preparing customised medicine dosages for patients.

According to Ayurveda, each individual is unique, therefore their treatment should also be unique. “We have evolved some best-in-class technology and practices that ensure that while we stay true to our commitment of providing high quality, authentic Ayurvedic treatment, we are also able to constantly monitor patient relief and quality of treatment,” adds Dr Partap Chauhan.

Jiva Ayurveda focuses mainly on diseases that are clas-

22 EXPRESS PHARMA December 16-31, 2015

sified as chronic and lifestyle disorders. There are great treatment options and outcomes that ayurveda has to offer to people suffering from disorders such as diabetes, joint pains, skin disorders, digestive problems, etc.

Dr Partap Chauhan explains, “Ayurveda as a treatment science seeks to find and address the root cause of the problem. So two patients with the same problems or complaining of similar symptoms, may be treated differently depending on the root cause of their problem. Authentic Ayurvedic practice is always customised to the patient’s unique prakriti-vikriti (balanced state – unbalance state) and the root cause of the disorder.”

Today, when the world is exploring the tele-medicine area, Jiva had ventured into this sphere way back. Eventually, it

started offering medicines through a person, who will identify the problem of patient and play a mediator role and deliver medicine. And it has been dedicated towards helping people understand Ayurveda and how its principles can be applied in their day to day lives.

Tele-medicine centre The Jiva Tele-Medicine Centre was established in 1998 as an integrated centre for tele-health consultation. Today, Jiva has over 400 Ayurvedic doctors and support professionals who have provided consultations to more than one million patients till date across 1800 cities and towns in India. It reaches out to patients who did not have access to good quality medical advice and treatment through it’s tele-medicine practice. The centre in Farid-

abad is the flagship centre with state-of-the-art infrastructure, which is also its indigenous and based on principles of sustainable design. Jiva has recently opened a tele-medicine centre in Pune and plans to expand further in the southern and eastern regions of the country to provide availability of this facility in regional languages. The centre in Pune will be offering services in Marathi to better cater to the local population in Maharashtra.

Madhusudan Chauhan, Director Business Development, Jiva Ayurveda, informs about the company’s new venture and its relevance in today's time, “One of the biggest healthcare challenges that the country faces today is the lack of availability of quality doctors and infrastructure to provide treatment services. The scenario gets worse as

you move away from major cities towards smaller towns and villages. Second, the incidence of lifestyle and degenerative disorders is growing at a very fast pace. India is one of the largest patient pools in the world for diseases such as diabetes, hypertension, obesity, arthritis, etc.

Ayurveda is a strong option for treatment of such lifestyle disorders. The challenge was how do we make it accessible to more people. To address this challenge, Jiva started its tele-medicine practice where patients can access their doctor at the convenience of their time and location and have the treatment delivered at their doorstep.”

Today, the company’s telemedicine practice provides consultation to over 6,000 patients daily who come from more than 1800 cities and town and innu-

AYUSH SPECIAL

merable villages spread across the length and the breadth of the nation.

Turning silver

nancial performance and expectations from the current year, Rishi Pal Chauhan informs, “We are looking at achieving a revenue of ` 75

crores for the financial year 2015-16 which is approximately 40 per cent growth over previous year.”

Jiva will be moving and cre-

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ate more offerings in the wellness space. As Ayurveda mentions it’s objective to not only cure the people who are suffering from a disease but also to

help the healthy retain their health, Jiva is coming out with offerings in the preventive and rejuvenation space. u.sharma@exppressindia.com

With two years away from celebrating its silver jubilee, Jiva has already outlined its corporate plans to add to the celebration.

While sharing the company’s corporate plan, Madhusudan Chauhan reveals, “Jiva aims to open 100 Ayurvedic clinics and treatment centres across India in various towns and cities. We will open more tele-medicine centres making the services available in the southern and eastern parts of the country and bring out treatment-based research in Ayurveda. There are plans to establish a university that would encourage people from all over the world to study, perform research and apply Vedic knowledge to a multitude of disciplines-healthcare, business, science, education, and so on. Having successfully carried out many health, educational, and social projects in the past 20 years, the founders are now ready to enter into the most important phase of their work-to establish the Jivagram.”

All these plans will not become successful without the support of manpower and Jiva too believes in it. At present, Jiva Ayurveda is a family of over 800 people across the world dedicated to the cause of bringing authentic Ayurveda to every home. Since people spend their considerable amount of active time at offices and workplaces, Jiva took the initiative to bring health and healthy practices at work and initiated a programme called Ayurcorp.

This programme teaches participants appropriate diet, exercises, breathing techniques and life practices that best complement their nature and context.

It provides them with tools that will help them integrate simple yet powerful healthy techniques, thereby not only helping them remain healthy but also enhance their productivity at work.

The company has grown manifolds in the last 23 years and continuing it further. Commenting on the company’s fi-

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cover ) I N T E R V I E W

‘Our aim is to provide a complete health and wellness ecosystem for babies and mothers’ After establishing successful business strategies in the pharma segment, Himalaya Drug Company is expanding its niche in the baby care segment as well. Within a span of eight years, the company has captured the business and is giving tough competition to its existing players. In an interaction with Usha Sharma, Chakravarthi NV, General Manager Marketing, Himalaya Baby Care Division, shares the company's marketing plans

Tell us about the ongoing activities of Himalaya Drug Company’s baby care division.

Our baby product segment relies on its herbal roots to tap the increasing number of consumers with a preference for natural products.

Himalaya’s baby care range consists of a wide range of products under ‘Pre-Bath’, ‘Bath’ and ‘Post-Bath’ category.

At present, we are raising awareness for our products through doctors and maternity homes. Our marketing activities are mainly focused on scientific promotion to doctors, nurse education programmes and ensuring visibility and availability of the range at pharmacies, chemists, supermarkets etc. We’ve taken a conscious decision to promote our products ethically, that is, through general practitioners (GPs), gynaecologists and paediatricians.

Rate (CAGR) of around 17 per cent. The increasing baby population in the country and higher disposable income of consumers have fuelled the rising demand for baby care products. Currently, we are the second largest brand in this category and have a vast product portfolio that addresses all the personal care needs of newborns — from shampoos, soaps, powder, wipes, diaper rash cream and massage oil to baby diapers and gift packs.

Recently, we have launched our baby massage oil in a new avatar - Shishu Malish Tel – specifically for Hindi speaking markets in Northern India. We are growing at a significant rate of 60-70 per cent every year that reflects customers trust in our products. We are looking at expanding our distribution and also aiming to reach out to more doctors.

How big is your market presence in India and how do you plan to expand it?

Indian baby care market is growing significantly at a Compound Annual Growth

Johnson and Johnson company has established its brand in the Indian market. Are there any plans to counter their market and how?

24 EXPRESS PHARMA December 16-31, 2015

Our marketing activities are mainly focused on scientific promotion to doctors, nurse education programmes

Johnson and Johnson have been in the Indian market for many years now. Himalaya Baby Care range was launched in 2007, hence, we are a relatively new entrant.

In a short span of time, our product line has grown and we have increased our market share, registering a consistent and healthy growth year on year. Our aim is to provide a complete health and wellness ecosystem for babies and mothers through our scientifically validated, herbal product range. These are formulated and tested to be mild and gentle on baby's delicate skin, hair and eyes.

Moreover, Himalaya has a strong equity in the pharma segment and our USP is that our products are rooted in Ayurveda and backed by research. Bonnisan, a digestive for infants, is a part of Himalaya’s pharma portfolio, which is a household name today. Liv 52 drops is a renowned product that supports infant’s liver health. Generations of mothers have used this product and have an implicit trust in the brand. This trust

is now transferred to our baby care range as well.

Besides, being a herbal range promoted through doctors, it has further strengthened our credibility.

Why do you feel end consumers should switch to your brands from others?

Baby care is a very sensitive segment, even when it comes to purchasing personal care products for babies, mothers and fathers choose a product only after extensive research or based on doctor recommendations. Keeping this in mind, we‘ve developed a range of products that are herbal, safe, hypoallergenic, clinical tested and completely baby-friendly. At Himalaya, the science of baby care is geared towards bringing the very best of natural care for infants and children, keeping in mind their special requirements.

The range has been formulated by a qualified team of scientist who have carefully selected timetested herbal ingredients, known for their safety and efficacy.

Finally, by promoting it

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ethically, we have ensured that parents are introduced to the range through a circle of trusted people in their network.

Which communication skills would you like to adopt to build your brand building exercise of Himalaya Drug Company's Baby care division?

Today, consumers are very well informed and do extensive research before buying products. Providing information on digital platform is of paramount importance for any company as our audience is very engaged on that front. We have introduced live chat sessions hosted for parents to raise concerns about their baby’s health and seek expert advice from renowned

paediatricians from the country. Along with digital media, we also aim to reach our consumers through on ground activities such as ‘My baby and Me’, which is a platform for mothers to engage in discussions with doctors and other mums, and to address their own health issues as well as concerns about their baby’s health.

How many products are currently present in the market and how many are in the pipeline?

Currently, we have 15 products in the pre-bath, bath and postbath category. We’ve added products like baby wipes, baby care gift packs and baby powder to our range. Himalaya recently entered the diaper market which is currently estimated at ` 1,800 crore and

Himalaya recently entered the diaper market which is currently estimated at ` 1,800 crore and is growing at a rate of 18 per cent per annum

is growing at a rate of 18 per cent per annum. Himalaya Baby Diapers are enriched with natural ingredients such as aloe vera and Yashada Bhasma which form a protective anti-rash shield. A first-of-its-kind, this anti-rash shield reduces the activity of harmful enzymes, inhibits the growth of microbes, and prevents diaper rash.

What quality parameters do you follow while manufacturing baby products?

Extensive dermal care studies and clinical trials have been conducted to determine and ascertain the safety and efficacy of each and every product in the range. We work closely with the regulatory authorities to ensure that we maintain the

highest quality standards in all production process.

Where are the manufacturing facilities located?

We manufacture our products in various locations in India, the major facility being in Bangalore which is a WHO-GMP-US FDA compliant facility. We have a dedicated and trained team of scientists to monitor product development. At Himalaya, we stress on quality and follow strict compliances.

Are there any plans to venture into the capital market?

We have no plans to venture into capital market in near future. u.sharma@expressindia.com

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IPC SPECIAL

26 EXPRESS PHARMA December 16-31, 2015

Industry leaders, analysts and opinion makers contribute their thoughts on important topics which will impact patients, the pharmacy profession and pharmacists to achieve the goal of ‘Healthy India - Swasth Bharat’ by 2020

BY SACHIN JAGDALE

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IPC SPECIAL

‘The pharma industry should come forward to give practical training to pharmacists’

W

ith the changing domestic and global scenario, it is high time education institutes also upgrade themselves. ‘Digital India’ is not a mere slogan. Various government departments are seriously working towards this goal. A regulatory system, world wide is making drastic changes. The masses are also aware about the efficacy and safety of medicines. Government, institutes, academic groups have to think of the pharmacy profession. Today, we are called the global pharmacy but the speed with which China and our next door neighbour Bangladesh are entering overseas business, our alertness is equally important. It is observed that students of pharmacy are academically sound enough, but their practical experience is not up to the mark.

This is due to lack of budget allocation of various institutions.

It is top class institutes like NIPER who can fill the gap.

The pharma industry should come forward to give practical

training to pharmacists. With the combination of practical as well as academic training, we can produce world class pharmacists in India as our students are brainy and intelligent as they have good grasping power.

As regards online pharmacy, it is a high time that the government should sit together with the stakeholders to avoid misuse of this system. If the present system of online pharmacy being used by many agencies is observed, there is high chance of abuse. Fake prescriptions can be created easily. It can also lead to black marketing, especially by offering high discounts. It can also exaggerate the risk of mis-interpretation of handwriting. Scan of a signature is not a valid system and Drugs &Cosmetics Act clearly mentions that dispensing can happen only if the signature of the prescriber is present. A document with a scanned signature cannot be produced as evidence in a court of law. The possibility of self medication

BR Sikri

}

Co Chairman, Federation of Pharma Entrepreneurs (FOPE); Vice President, Indian Drugs Manufacturer Association (IDMA); Vice President, Confederation of Indian Pharmaceutical Industry (CIPI); Vice President, Bulk Drugs Manufacturers Association (BDMA)

and non-compliance to therapy is also present.

Similarly there are mentally retarded patients who can be at risk by providing easy accessibility of medicines. The possibility of misuse of narcotics products is also a serious matter.

This system of online pharmacy is futuristic and convenient for patients, but unless the loopholes are plugged properly, it will be dangerous to allow people to start this system without legal clearance. Convenience

can never be a reason for relaxing rules with regard to medicine dispensing as it can also lead to huge ease of abuse.

India is already grappling with so many youths taking to substance addition. Indian society cannot face such abuse by relaxing rules on dispensing.

The system has to be foolproof.

While introducing the technology for online pharmacy, the factors to be taken into considerations are: ◗ Sanctity of prescription has to

be kept in mind. ◗ There should not be any possibility of abuse for multiple dispensing. ◗ There should be end to end transparency and visibility ◗ Improvement in technology to reduce the errors, if any ◗ It should be truly convenience to the customers and commercial angle should not be the hidden agenda in the mind of those entrepreneurs who want to start online business. ◗ True enhancement in patient safety, convenience and improving overall compliance therapy.

In the end, I would like to mention that prescription directly from doctor to pharmacy with a valid digital signature with every prescription should be the only right future model. This should be introduced by a proper amendment in the Act and by bringing awareness to the doctors as well as to the patients. It should run on trail for couple of months before it becomes nation level drive. Let us create a safe and healthier nation.

‘India is today going in the direction of becoming more unhealthy by 2020’

P

harma Vision 2020: Healthy India — Swasth Bharat is a mirage. Health deteriorates due to lifestyle, pollution, food habits, stress and a variety of other reasons over which pharmacists have no direct control. So the disease burden of the nation, especially chronic diseases, is set to rise and much as we do not wish, the fact is India is today going in the direction of becoming more unhealthy by 2020.

This fact ushers in a much

28 EXPRESS PHARMA December 16-31, 2015

Ameesh Masurekar Director – AIOCD AWACS

}

bigger responsibility – how to ensure affordable and quality treatment to the masses. The key players are listed below and there will be power shifts within them.

■ Doctors ■ Pharmacists ■ Pharma Companies ■ Hospitals ■ Medical Insurance Companies ■ Pathlabs Government can be a player for populist reasons, but ideally they should make

wise policies and implement them – competition will take care of the rest.

Let’s dwell on role of pharmacist in the retail channel.

This is the area where maximum change is already happening and the business practices in 2020 will be vastly different. Some will evolve (rapidly) and there will be several thousand dinosaurs.

There are big challenges and massive opportunities.

Regulations and laws will be enforced much more. So

IPC SPECIAL non-pharmacist dispensing will end and pharmacist will be a must to dispense each and every prescription – 300 per cent growth in job opportunity or demand. Imagine if all chemist dispensing boys are replaced with registered pharmacists! One may think India may not change, but let us understand competition brings faster change than government laws and enforcement. The organised / online business will follow certain regulations (as they are large corporates, not individual owners). To survive and compete with them – the smaller pharmacies will have to match up – in compliance, service and cost.

The role of doctor will be to diagnose and choose the molecules.

The role of pharmacist will be to decide the brand. Pharma marketing will change for ever and there will be tremendous shift of power in favour of pharmacists The pharmacist will be more involved, as the patient is becoming highly educated due to internet and doctors does not have time to answer all his/her questions. So right from medication timing, contraindications, lifestyle changes, food habits, counselling and other such services will be the key to maintain / grow business by retaining loyal customers.

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The Indian pharmacist will have to step up and play the role like their US counterparts. As they do this, the respect they get will increase as a healthcare worker and pay will increase.

Finally as brand replacements and generics become rampant, the pharmacist will

be in increasing control of which brand to choose and doctor will increasingly lose this control. The role of doctor will be to diagnose and choose the molecules. The role of pharmacist will be to decide the brand. Pharma marketing will change forever and there will be tremendous

shift of power in favour of pharmacists. Hope we are wise and responsible to handle this. For non-believers, consider this fact: 28 per cent of medicine brands sold in India are decided by pharmacists today and every developed country has moved from a doctor led model of choosing

a brand to a pharmacist led model over time! Example: the US, Canada, Europe and parts of South America.

Students graduating as pharmacists now and over the next few years will be at the right time and right place to serve the nation as well earn a rewarding career.

IPC SPECIAL

‘We are still at the bottom of all the levels of regulations — at industry, at sales and at education’

O

ne of the important means to achieve the goal of ‘Healthy IndiaSwasth Bharat’ by 2020 is the provision of essential medicines. It might reasonably be assumed that the provision of safe, effective and affordable medicines of good quality and in the right quantity to the whole population would be a priority in the health policy of any country and relatively uncomplicated goal to achieve.

Reality seems to show otherwise.

About half of the Indian population still continue to be denied their right to health.

They lack reliable access to essential drugs, while at the same time overuse and abuse of medicines is frequently reported.

This state of affairs highlights the regrettable fact that worldwide governments have little influence over the big private market. Waves of privatisations during the past decade have aggravated the situation and have in some countries reached absurd proportions. Private pharmacies are mushrooming in recent years and people buy whatever they want.

In India, too, the state’s spending on health is too lowabout 1 per cent of the gross domestic product (GDP). This results in private expenditures

accounting for 78 to 80 per cent of total health spending in the country. At an industry level, currently, due to high expenditure on innovation of new medicines, there are no breakthrough innovations. There is loss of patents on one side and cut throat price competition by the generics, and unreasonable price control by the states on essential medicines on the other side. This is resulting in a shrinkage of ethical market.

Today’s physician alone is not in a position to handle the complex task of pharmaceutical care effectively, as he is already overworked with his usual therapeutic responsibilities. As the situation changes in a rapidly evolving health system, it is therefore, internationally well accepted that the pharmacist is responsible for pharmal care in a health set up.

All these forces are currently, leading to the creation of new markets called ‘Mass Commodity Drugs’, where more and more drugs are pushed from prescription to non- prescription category, and would be easily available over the counter (OTC).

Pharmacies are becoming new market points and treatment centres for minor ailments. enhancing pharmacy’s role in self treatment and med-

Dr Suresh R Saravdekar

}

Ex- Asst. Director & Consultant, Ministry of Medical Education, Health & Municipal Corporation of Greater Mumbai Chairman- IPA- MSBHospital Division

ication in categories such as analgesics, antipyretics, coughn-cold, allergies, antacids, vitamins, insomnia etc. In developed countries there is a change in the supply chain too.

The traditional mode of ‘Manufacturer-to-Wholesalers-toDrugstore’ has adapted to ‘Direct-to-Pharmacy’ (DTP model), which is to encourage self medication and to demand prescription by the patients.

In India, we are still at the bottom of all the levels of regulations — at industry, at sales and at education. There is lack of adequate law enforcement leading to manufacturing of all sorts of non-essential drugs, fixed dose combinations of drugs, (already about one lakh medicines in the market), sale

of ‘prescription only’ drugs without prescription by the pharmacists, prescribing medicines by unqualified quacks, and rampant irrational use by physicians, and extensive self medication by the patients.

Under these circumstances, irrational use and misuse becomes uncontrollable. Medication errors would be very widespread. The consequences of which are costly in terms of hospitalisation, physician’s visits, laboratory tests, and remedial therapy. In developed countries four to 10 per cent of all hospital in-patients experience an adverse drug reactionmainly due to the use of multiple drug therapy, especially in elderly and patient with chronic diseases. In India, cur-

rently, there is no data available on these issues. What is needed is awareness and education of all stakeholders namely policy makers, regulators, industry, physicians, pharmacists and patients on all above issues.

But no positive role is played by the govt or by the industry in this regard.

At education level too, there is a mushrooming of pharmacy colleges all across the country, without any regulation of the quality of education. Forget about D.Pharm. Even, today’s B. Pharmacy students too are not trained to shoulder these new emerging challenges.

I think, in India, there is a long way to go!!

What is needed is a clear, robust drug and education policy (without any backdoor).

The essential elements of policy would be strong political will, removal of apathy at all regulation levels and patients safety at its core. Otherwise, promoting medicines as ‘Mass Commodity Goods’ through retail outlets and prescription monitoring through (Pharm –D) half-trained clinical pharmacists would not only be unsafe but would be disastrous and would risk / endanger poor patient’s health and tarnish the image of pharmacy profession.

‘Reforms in pharmacy education especially for diploma in pharmacy should take place urgently’ Challenges facing healthcare including pharmaceutical care in India continue to include rising cost of health care, limited financial resources, the huge burden of diseases, access of medicines of assured quality , rational

30 EXPRESS PHARMA December 16-31, 2015

use of medicines the pharmacist needs to be positioned at the forefront of healthcare system.

The role of community pharmacists in India is still largely confined to have suppliers of pharma products

rather than providers of patient care. It is important to realise that efforts to communicate the correct information to patient is as important as providing medicines itself.

Similarly, pharmacists have a significant contribution to

make to patient care through managing drug therapy. Access to good quality medicines and competent and capable healthcare professionals are fundamental aspects of any healthcare system. Investment in transforming and

scaling up professional education as per country’s needs is crucial as education provides the foundation for a capable healthcare work force. Ongoing efforts are needed to ensure capacity building of skilled medicine practitioners

IPC SPECIAL meet pharma care needs of populations.

Role of government and pharma companies in educating pharmacist: Board of Apprenticeship Training (BOAT), Ministry of Human Resource Development, Government of India, provides support for job training in pharma industries. Persons acquiring skill during the training are eligible for gainful employment. However, very few fresh pharmacy graduates avail the opportunity and facilities extended by the Government of India probably due to lack of awareness. Efforts should be made by placement cells of pharmacy institutions to establish a dialogue with BOAT and to ensure that the benefit of the programme extended by Gov-

Dr MNSaraf Principal and Professor of Pharmacology, Bombay College of Pharmacy, Mumbai

ernment of India reaches to the needy pharmacy graduates.

Education regulation (E.R.) was framed in 1953 and was subsequently amended in 1972, 1981 and 1991.For proposed new amendments in E.R. approval by the health

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}

ministry is awaited.

PCI has proposed Pharmacy Practice Regulation. Education and training provides the foundation for pharma services and professional development order to meet global societal needs for medicine expertise.

The role of community pharmacists in India is still largely confined to have suppliers of pharma products rather than providers of patient care. It is important to realise that efforts to communicate the correct information to patient is as important as providing medicines itself Reforms in pharmacy education especially for diploma in pharmacy should take place urgently. New paradigm for pharmacy requires that the pharmacist understands and applies the principles behind

all activities necessary to manage drug therapy. There is a need to shift diploma in pharmacy education in the country from traditional laboratory based sciences to practice and clinical sciences.

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December 16-31, 2015

IPC SPECIAL

‘The focus should be on skill development and enhancement of competency and employability’

P

harmacy profession in India is full of contradictions. On one hand, India is recognised as the pharmacy of the world and caters to the needs of majority of the population across the globe by providing quality generic medicines at affordable prices. On the other hand, it is claimed that majority of the population especially below the poverty line in India cannot afford medicines and therefore do not have proper access to medicines.

Pharmacists in India are not considered as one of the best and is not recognised as the vital component of healthcare delivery system. Though, the pharmacist contributes immensely in the area of research, product development, manufacturing and quality control, the society as a whole does not recognise the pharmacist and his contribution in the healthcare delivery system. Perhaps this is because of pharmacist’s failure to connect with the society. The major interface of the pharmacists with the society is through a retail pharmacist who comes in contact with the patients and his relatives and consumers etc.

However, the retail pharmacist in India is identified more as a person selling medicines across the counter and not as the healthcare provider. This perception can only change if the

retail pharmacist plays his original role as community pharmacist and plays a major role in patient counselling, providing information about drug dosages, compliance drug interaction etc.

Policy makers in India have realised the need and have therefore issued Pharmacy Practice Regulations, 2015 in exercise of its powers under Pharmacy Act, 1948. Under the said regulations, pharmacist’s role, duties and responsibilities have been specifically defined and pharmacist’s is obliged to review the patient’s records and each prescription presented to him. The pharmacist is expected to identify factors such as therapeutic duplication, drug dosage interaction incorrect drug dosages or duration of drug treatment etc. He is also expected to initiate discussion with the patient or his relative on matters that will enhance or optimise drug therapy. The focus is thus shifted to patient counselling for the first time.

If a pharmacist performs his duties and discharges his responsibilities as envisaged in Pharmacy Practice Regulations, 2015, it will bring about qualitative changes in patient care. It will promote compliance of dosage schedule and rational use of medicines. The society will then certainly give recognition to the pharmacist for which

Sudhir Deshpande Legal Consultant, Pharmalex

he is craving. However, is the present day pharmacist equipped and trained to undertake these responsibilities? Unfortunately, the present curriculum for B Pharm or D Pharm is not good enough to prepare the pharmacist to perform his function either as a community pharmacist or as a professional in pharma industry. Many academicians are of the view that pharma education has extended in goalless and unmindful way producing unemployable graduates from substandard educational institutions. May be it represents an extreme view but the fact remains that the quantity has taken a front seat at the cost of quality. There is certainly a need to redefine pharmacy education, change the curriculum to give practical orientation. There

}

has to be more industry academia coordination, exposure of students to the pharma industry and focus on patient counselling.

Internet pharmacy or online pharmacy has become a subject of intense debate, scrutiny and even controversy. Many divergent views are being expressed with promoters of e-pharmacy strongly advocating support and are demanding clear guidelines and regulations. On the other hand, pharmacists are strongly opposing this business model claiming adverse impact on public healthcare due to indiscriminate sale of prescription drugs. Perhaps such opposition is arising out of apprehension of losing business. Against this backdrop, when examined in the context

of existing drug regulations, it can be seen that the existing regulations do not explicitly regulate online pharmacy and it also does not prohibit this activity. Online pharmacy can be operated as long as operations are in compliance with the existing provisions of the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

It’s a myth that online pharmacies will operate without pharmacist, will sale without prescription and will lead to self medication etc. The fact is except same aberrations, orders are executed by the licensed pharmacies in compliance with conditions of licenses. It is a fact that it provides many advantages to the consumers, especially, ease and speed in procuring the required drugs. With entry of organised sector it will provide value addition to retail space. However, there is a need to formulate specific and clear regulations in the light of existing drug regulations and Information Technology Act, 2000.

To conclude, it should be noted, law is need based and will change if there is a need. If Internet pharmacy is in the interest of consumer, necessary changes will have to be effected in the regulations providing necessary safeguards to protect interest and health of the consumer.

‘A foolproof regulated channel has to be brought in’

I

t is true that the market is flooded with newer and newer formulations every month and not every quarter.

This happens to be the order of the day as we have that many manufacturers and that many state drug licensing authorities in the country.

Though DCG(I) and CDSCO

32 EXPRESS PHARMA December 16-31, 2015

have pegged this exodus through demands of clinical and bio equivalent studies, still the exploitations through loopholes exist and we have many FDCs coming into the market. Retailers frankly are not interested in this sort of set up as their investments unnecessarily go up in build-

ing up stocks and thus there comes an expanded and enlarged inventory problem for them.

This is equally true with wholesalers as well as distributors. Influencing the medical profession with such trivial changes in the fixed dose combinations has been the order

of the day and all sorts of lucrative promotional inputs are attempted at doctor’s level. Frankly this is not a good picture to relish and ultimately, the patient bears all the brunt. Pharmacists – the so called diploma holders who man the chemist shops are truly not interested in getting

into the nitti gritty situations of healthcare and mostly are only employed in the retail shops as employees except for a few of them who own the shops.

It would really require an ardent attempt to make our retail chemists a more professional body and the shop

IPC SPECIAL manned by a true pharmacist – a B Pharm graduate who understands the subtle nuances of medicine and its true values. A pharmacist who is a B Pharm graduate becomes a more able counsellor when it comes to retailing and advising the patients. An appropriate skilled development programme is necessary to be conducted with all the diploma holders to make them understand their due role in the society as responsible dispensing pharmacists. These diploma holders need to obtain a continuous upgrading education on medicines, diseases and pharmaco-vigilance programmes to be adopted by them at the retail counters so as to help the patients understand the role and importance of the medicines. In return, the drug authorities too, do

Subramanian Vaidya

}

Director- BlissGVS Pharma, Chairman-IDMA(MSME-sub committee)

get the adequate data in these matters to take cognisance of.

The companies hardly play any role in educating the pharmacist, broadly. Of course the companies do talk about their individual products and make them aware of their availability in the market

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through their respective distributors. Government of India and FDA do have some skeletal programmes but a concerted effort has to be put in place in order to make the pharmacist more responsible to the society as a whole. Online pharmacies cannot be

truly ruled out totally. The existing retailers of course are not in favour.

A proper foolproof regulated channel has to be brought in, with rigid regulations, thus enabling the access to medicines for the entire population including rural India. Anyway it is a long drawn process.

Risk as of now, is there in both forms of dispensing.

Even retail shops are not able to control the dispensing of unwanted medicines in various locations.

FDA authorities have been trying to control this phenomenon with all their available resources. D Pharm curriculum has to be updated to the present day needs and there has to be a continuous educational programme taken up by the diploma holders from time

to time and their licenses should be reviewed and renewed only after confirming the mandatory education inputs at due intervals.

The entire profession of pharmacy should be given a holistic recognition rather than as a commercial outlet to make profits alone, as is the situation now, in our country.

Exceptions are there but it is rare. An all India retail pharmacy magazine with authentic inputs from experts will go a long way in educating these diploma holders from time to time. The company intellectuals and experts can indeed contribute in these magazines and thus, their inputs can have a far reaching output in terms of education and up gradation to these retail chemists and pharmacists sachin.jagdale@expressindia.com

EXPRESS PHARMA

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December 16-31, 2015

IPC SPECIAL INSIGHT

Community pharmacists: Need of the hour Manjiri Gharat, Vice President and Chairperson, The Indian Pharmaceutical Association, speaks on the role of community pharmacists in effective healthcare delivery, highlights the fact that the concept has not evolved in India and recommends involving pharmacists in national health programmes for improved results CASE 1: A medical shop in a rural area. One early morning, as soon as it opened, a customer walked in and asked for a painkiller. Instead of simply handing over some tablets, the pharmacist enquired more about the symptoms and understood that the patient had pain on left side of his shoulder, and his back. He also had some uneasy feeling as well as numbness in the extremities. The pharmacists asked the patient to sit inside the shop for a few minutes and then checked his blood pressure. On finding it to be very high, he counselled the patient to visit a nearby district hospital.

Subsequently, the patient was diagnosed as hypertensive and a few days later he came back to thank the pharmacist for diagnosing his condition.

CASE 2: A chemist shop in a busy metropolitan city. A TB patient walked into a pharmacy along with a family member.

Pharmacist saw the patient and took out the patient’s medicine box from an inside shelf. He gave the tablets to the patient and offered him water. The patient consumed the tablets and the pharmacist made some entry in the patient’s card. He also interacted with the patient about the current status of his health. He also checked the patient’s weight on a weighing scale. The patient thanked the pharmacist and left.

It might be a little surprising to read the above cases, but they are real life incidents. One can clearly see the active role that the above two pharmacists have taken up and their positive intervention in the lives of the patients. How many pharmacists take up such roles in our country? Well, it will be a challenge to find such ‘healthcare pharmacies in our country. The usual scenario is where a patient walks into the pharmacy, asks

34 EXPRESS PHARMA December 16-31, 2015

for medicines with or without prescription, makes the purchase and leaves the pharmacy.

For years together, this has been the scenario in seven to eight lakh pharmacies across the country. We hardly even know if a pharmacist is present at all pharmacies of the country. This is the grim reality of the pharmacy practice in our country. On one side, we are making incredible strides in the pharma industry but on the other side, the pharmacy practice has not seen the same rate of progress. It has turned out to be a trade rather than a part of the healthcare profession. The Drugs and Cosmetics Act, which was made way back in 1940, could not be enforced in the practice sector.

As a result, ensuring a registered pharmacist in all shops remains a struggle and the role of the pharmacist has hardly developed. In fact, it is disheartening that in some states across the country, there is an increasing demand that the Act should be modified and the clause demanding a full-time pharmacist in each pharmacy should be deleted from the Act. Globally, the concept of a community pharmacy is well developed and except for a few countries from the South East Asian region and Africa, the pharmacist is a link between the doctor and the patient, and a true patient counsellor. The pharmacists’ duties and responsibilities have advanced and expanded to such an extent that they have become a key component of the healthcare team.

Health advice, medication therapy management, immunisations, home medicine reviews, emergency prescribing, clinical measurements, and health advice are just a few of the services which a pharmacist provides to the society. In several Gallup

polls, pharmacists have bagged first or second positions as most trusted professional among various professionals such as doctors, lawyers, bankers, teachers etc. Optimum utilisation of this human resources for health definitely makes a positive contribution in healthcare.

Clinically oriented education, appropriate educational and drug policies and its effective enforcement, excellent leadership and advocacy, good remuneration, well aware consumers and strong political will are important factors which have helped to develop the pharmacists’ role. In our country, we have lagged behind, resulting in the current situation.

Awareness is very low among our consumers. Medicines’ misuse is rampant in the country.

Overuse, underuse, wrong use of medicines lead to adverse drug reactions, therapeutic failures, relapse of the diseases, and of course increased expenses.

Problems like antibiotic resistance have emerged due to such incorrect use and India has become the country with highest drug resistance. There is no one to guide the patient about medicine usage. Medical professionals are busy and so are health experts and diagnosis experts.

Relevant information for patients is, by and large, not available with the medicines. The concept of package insert has not evolved in the country and unlike many other countries, it’s not a mandatory requirement for pharma companies. The

pharmacists’ role is still just that of a drug seller than of a medicine counsellor. This situation leads to a state of confusion among the patients. Health literacy is anyway not great in India and overall there is a casual attitude in this regard. Selfmedication is very common and easy availability of medicines over the counter due to lack of strict enforcement of drug laws encourages self-medication. The situation is further complicated by the fact that more than 100,000 formulations are available in the market, and there exist a variety of wrong practices for profitability by pharma companies and the supply chain.

Overall, the situation is chaotic.

Rising graphs of non-communicable as well as infectious diseases clearly show the unhealthy condition of the country.

In a recent report by World Economic Forum on the health status of the countries, India is way behind and is ranked at the 103rd position. A significant percentage of population is pushed below the poverty line due to out of pocket expenditure on healthcare.

There are around seven lakh pharmacies in the country. Just imagine for a moment that every pharmacy has a registered pharmacist and the pharmacy offers patient care services as exemplified by the cases described in the beginning of the article. If this happens, in a country where poverty and illiteracy are major concerns, it could make a huge difference in the lives of the people. Pharmacists are the first point of contact for most patients. Hence, they can play a vital role in health promotion and disease prevention. A few pharmacists who have taken up such a role have proved that their contribution can make a significant difference.

Till now, the most positive example in the community pharmacy is the participation of pharmacists in the Revised National Tuberculosis Control Programme (RNTCP) by the Govt. of India. Started as a small initiative in Mumbai in 2006 by Indian Pharmaceutical Association (IPA), over a period of time, it has grown to a national level with the support of other partners and the encouragement of the Central TB Division, Ministry of Health and Family Welfare. In this pharmacistcentric model for TB care and control, trained pharmacists refer the chest symptomatic cases for diagnosis and help in early detection of TB as well as provide Directly Observed Treatment, Short Couse (DOTS) medicines to the patients and monitor the treatment. It helps to increase the outreach of DOTS services and thus increase access to free medicines. Positive evidence of their work and advocacy led to the entry of pharmacists in the national health programme.

This PPP is slowly spreading across the country. This model has set an example and shown that even in the existing ‘trade’ scenario of pharmacy practice, pharmacists can be engaged and utilised for patient care. It has shown the importance of training and including community pharmacists in other national health programmes to start utilising this untapped human resource for improving public health. To progress towards Sustainable Millennium Goals, we must start utilising every healthcare resource.

The pharmacy practice in India needs an overall revamp to progress and be at par with the global pharmacists. However, it may take several years if at all the process starts.

IPC SPECIAL

Albert David launches two new products, to further strengthen EVICTrange The company’s turnover is expected to touch ` 340 crore by the end of March 2016 KOLKATA'S LEADING pharmaceutical company Albert David, a unit of the Kothari group, has undertaken a range of robust initiatives to maximise its growth. The company aims to develop brands and generate maximise revenue from them in the current fiscal year.

“In the current fiscal, we plan to further strengthen evict range by launching EVICT-XF,” said Kamal Prasad Mundhra, Executive Director, Albert David.

Albert David, which makes pharma formulations, bulk drugs and injections, has three manufacturing plants — in Kolkata (for tablets and powder, small volume parenterals, oral liquids, bulk drugs), Ghaziabad

(for IV fluids in glass and polythene containers using the latest Form-Fill-Seal (FFS) technology and small volume parenterals) and Mandideep (disposable syringes and needles).

In the last fiscal (2014-15), the company, touched a turnover of ` 320 crore and is expecting to touch ` 340 crore by the end of March 2016.

The company has successfully launched Alamin Liquid and Alamin RLD (L-Arginine Sachet) in the last fiscal year.

Mundhra said, “The success of Derek & Breaze range has opened up the possibilities to venture in pre-probiotic and respiratory markets. Also we shall further strengthen our Gy-

Kamal Prasad Mundhra, Executive Director, Albert David

nae portfolio.”

Mundhra further added, “The company has given much

thrust on its research and development initiatives. The company has made significant investments in fully renovating and expanding its R&D facility at Kolkata. The facility had been further equipped with more analytical and functional instruments as well as manpower to enhance its R&D capability to deliver more advanced and efficacious dosage forms in oral solids, oral liquid and some APIs. During the year, main activity areas were on expanding the knowledge base about Placentrex constituents. Two new products were introduced in the domestic market and some outsourced products are almost ready with improved quality versions for commercial ex-

ploitation.”

To expand the geographical reach of the company's products in export market, number of dossiers have been submitted in different countries. Approval of some dossiers has been received during this financial year.

Commenting on the Indian pharma industry, he said that the Indian pharma industry is passing through challenging times. It is witnessing a big change due to the government's pricing policy and severe price competition.

But inspite of these, Albert David will continue to grow with the current strategies in place and is equipped to meet any future challenges, he added.

EP New Bureau–Kolkata

RESEARCH I N T E R V I E W

We are working on a strategy to cover emerging strains by the broadly protective vaccine Dr Suresh Mittal, Professor of Comparative Pathobiology at Purdue’s College of Veterinary Medicine, Purdue University, US, gives details of his research on broad range vaccine for avian influenza, in a discussion with Sachin Jagdale

What are the criteria to get the grant of $1.55 million from The National Institutes of Health [USA]?

The National Institutes of Health has one of the best peer-review system in the world for funding the scientific research proposals based on scientific merit and programme priority. Only approximately 10 per cent of submitted applications receive funding.

anticipate that the trial will be conducted in the US. Is there any example of such broad range vaccine that is already in use?

There is no such broad range vaccine that is available at this time. There are a number of groups worldwide who are working to develop a universal influenza vaccine.

When is this broad range vaccine expected to enter the market?

It is difficult to predict the time-frame at this stage.

What are the challenges that are faced while developing broad range vaccine for avian influenza?

Development of balanced and cross-reactive immune responses against conserved epitopes is important for designing broadly protective vaccine for avian influenza.

How long will this vaccine remain effective for?

These studies will be conducted with our best candidate vaccine. Our preliminary results in experimental animals suggest that the vaccine effectiveness may be longer than the seasonal influenza vaccines.

36 EXPRESS PHARMA December 16-31, 2015

If any new virus strain is discovered, can the strain be included in this broad range vaccine?

We are working on a strategy in which many of the new emerging strains will be covered by the broadly protective vaccine. If the changes in the vaccine

formulation are required, it will be easy to adapt it quickly.

Will this vaccine have any side effects? If yes, give details.

The current vaccine formulation does not seem to have noticeable side effects in animals. We will only know

about the potential side effects when we will conduct Phase I clinical trial.

Have you identified any communities whom you would like to conduct the trials on?

We do not have an answer to this question at this time. We

Will you be joining hands with any biotechnology/biopharmace utical company to commercialise the broad range vaccine?

There is always a possibility of licencing this technology to a commercial company for its production, marketing and further development.

Alternately, we have excellent support at Purdue University to establish a startup company at Purdue Research Park. sachin.jagdale@expressindia.com

RESEARCH UPDATES

US FDAapproves new Bristol-Myers treatment for multiple myeloma US FDA has approved the treatment, Empliciti, in combination with Celgene Corp's Revlimid and common anti-inflammatory drug dexamethasone THE US Food and Drug Administration (US FDA) has approved a drug to be sold by Bristol-Myers Squibb Co as a treatment for a form of blood cancer. The FDA said it approved the treatment, Empliciti, to be used in multiple myeloma patients in combination with Celgene Corp's Revlimid and common anti-inflammatory drug dexamethasone. The National Cancer Institute estimates there will be 26,850 new cases of multiple

myeloma and 11,240 related deaths in the US in 2015.

Research has shown that combination treatments increase the time that multiple myeloma patients survive without the disease. The FDA said that Empliciti is the second immuno-oncology treatment for multiple myeloma to be approved, after Johnson & Johnson's Darzalex. BristolMyers and AbbVie co-developed the drug, but Empliciti will be sold only by Bristol-My-

ers. The company is considered the leader among drugmakers racing to develop a new wave of cancer treatments that harness the immune system, including its recently approved immuno-oncology product Opdivo.

Opdivo was approved in December for advanced melanoma and was approved in March to treat the less-common squamous type of nonsmall cell lung cancer.

Reuters

Research raises questions over ADHD drug effects Side-effects include higher risk of sleep problems and loss of appetite RESEARCHERS voiced concern about poor quality studies on the popular ADHD treatment Ritalin, saying evidence of some benefits, but also of sleep problems and appetite loss, suggests the drug should be prescribed with caution. Ritalin is sold by Swiss pharmaceutical firm Novartis NOVN.VX, known generically as methylphenidate and also sold under the brand names Concerta, Medikinet and Equasym. It has been used to treat Attention Deficit Hyperactivity Disorder (ADHD)for more than 50 years.

The Cochrane Review researchers, who conducted a full assessment of studies on the benefits and harms of the Attention Deficit Hyperactivity Disorder (ADHD) drug, said

The Cochrane Review researchers, who conducted a full assessment of studies on the benefits and harms of the Attention Deficit Hyperactivity Disorder (ADHD) drug, said evidence on its use in children was poor evidence on its use in children was poor.

"Our expectations of this treatment are probably greater than they should be," said Morris Zwi, a London-based consultant child and adolescent psychiatrist, who worked on

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the review. "Whilst our review shows some evidence of benefit, we should bear in mind that this finding was based on very low-quality evidence. What we still need are large, well-conducted trials to clarify the risks versus the benefits."

Cochrane Reviews are conducted by international panels of independent researchers and considered as studies of the best available science on a topic. Jonathan Green, a professor of child and adolescent psychiatry at Britain's Manchester University who was asked to comment on the Cochrane Review, said it would be "wrong to draw the conclusion that methylphenidate is ineffective.

The Cochrane Review included data from 185 randomised controlled trials involving more than 12,000 children or adolescents. The studies were conducted mainly in the US, Canada and Europe, and each one compared Ritalin with either a placebo dummy pill or no intervention. ADHD

is one of the most commonly diagnosed childhood disorders and can continue through adolescence into adulthood.

Symptoms include difficulty focusing, impulsive behaviour, and extreme hyperactivity. It is estimated to affect about five per cent of children. In their review, the Cochrane researchers found that Ritalin led to modest improvements in ADHD symptoms, general behaviour, and quality of life, but that side-effects included a higher risk of sleep problems and loss of appetite.

The researchers added, however, that their confidence in the evidence was low since many of the trials were not conducted with sufficient rigor and results reporting was not complete.

Reuters

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RESEARCH

US FDAapproves Lilly’s lung cancer drug The treatment will need to carry a 'boxed warning' that flags potential fatal risks, including cardiac arrest and sudden death THE US Food and Drug Administration (US FDA) had approved Eli Lilly & Co's Portrazza, in combination with two forms of chemotherapy, to treat patients with a type of lung cancer. However, the treatment will need to carry a 'boxed warning' that flags potential fatal risks, including cardiac arrest and sudden death. A 1,093-patient clinical trial showed that patients who received Portrazza, along with chemotherapy drugs gemcitabine and cisplatin, survived an average of 11.5 months compared with 9.9 months for

those who received only chemotherapy treatments.

The FDA's approval comes about four months after an ad-

visory panel to the agency recommended the drug be cleared for sale along with the warnings.

Lung cancer is the leading cause of cancer death in the US, with about 221,000 new diagnoses and 158,000 deaths so far in 2015. Portrazza is approved to treat advanced squamous non-small cell lung cancer, the most common type of lung cancer.

It is not approved for the second type of non-small cell lung cancer, non-squamous cell.

Reuters

FDA panel says BioMarin DMD drug data not persuasive enough The panel focused on the data and its interpretation after hearing out 26 speakers, mostly parents who showed videos of their boys benefiting from taking drisapersen A PANEL of outside advisers to the US Food and Drug Administration (US FDA) indicated that efficacy data from BioMarin Pharmaceutical on its experimental drug for treating a muscle wastage disorder was not persuasive enough to warrant approval.

The US FDA panel did not officially vote on an approval of the drug, but 15 out of 17 members were of the opinion that the lack of statistical significance in BioMarin's latestage study weakened the findings from two earlier studies.

The drug, drisapersen, is being developed to treat Duchenne muscular dystro-

38 EXPRESS PHARMA December 16-31, 2015

phy (DMD) - a disease that affects one in 3,600 newborn boys and causes rapid muscle degeneration. The FDA will decide on the approval of the drug by December 27, after considering the panel's comments.

The vote comes after FDA staff raised concerns about the drug that included potentially fatal long-term side effects. "I don't think they (BioMarin) will necessarily be able to convince the FDA staff to change their mind," Heather Behanna, an analyst at Wedbush Securities said, noting that additional data on the drug could help making BioMarin's case. But RBC

Capital Markets analysts said the health regulator could still find BioMarin's drug approvable given overall risks and benefits.

The panel focused on the data and its interpretation after hearing out 26 speakers, mostly parents who showed videos of their boys benefiting from taking drisapersen.

Only one of the parents said the side effects were not manageable.

BioMarin's strategy going forward could be discussing with the FDA on what else it could do, some analysts noted, after the health regulator's staff posted their preliminary review.

Rival drugmaker

Sarepta Therapeutics is also developing a DMD treatment.

The drug eteplirsen, like BioMarin's drisapersen, skips a faulty section of the gene to produce dystrophin, the lack of which causes DMD. "Sarepta's review will also be tough. Their long-term prospects because of better safety data are pretty good," Wedbush's Behanna said.

The fate of Sarepta's drug, which will go through a similar vote in January, will depend on how the FDA looks at dystrophin levels as a biological indicator for DMD, Behanna added.

Reuters

US FDA approves expanded use of Emergent BioSolutions’ anthrax vaccine THE US Food and Drug Administration (US FDA) has approved to expand the use of Emergent BioSolutions' anthrax vaccine to prevent suspected or confirmed exposure to the bacterium that causes the disease.

The FDA approved the vaccine, BioThrax, for use in patients who are between 18-65 years of age in conjunction with antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure. It is the only FDA-licensed vaccine for the disease.

The US health regulator also approved the company's treatment for inhaled anthrax, Anthrasil, in March. Anthrax disease, especially in the inhaled form, is often fatal if not promptly treated.

Anthrax, which has been used as a weapon for nearly a century, is still considered as one of the most likely agents to be used in biological warfare.

Anthrax can be found naturally in soil and affects domestic and wild animals.

People get sick if they come in contact with infected animals or contaminated animal products.

Reuters

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RESEARCH

Scientists create mosquito strain with malaria-blocking genes Gene-editing, a genetic engineering technique in which DNA can be inserted, replaced or deleted from a genome, was used on a species called Anopheles stephensi that spreads malaria in urban India

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SCIENTISTS AIMING to take the bite out of malaria have produced a strain of mosquitoes carrying genes that block its transmission, with the idea that they could breed with other members of their species in the wild and produce offspring that cannot spread the disease. The researchers said they used gene-editing, a genetic engineering technique in which DNA can be inserted, replaced or deleted from a genome, on a species called Anopheles stephensi that spreads malaria in urban India.

They inserted DNA into the germ line, cells that pass on genes from generation to generation, of the species, creating mosquitoes with genes that prevent malaria transmission by producing malaria-blocking antibodies that are passed on to 99.5 per cent of offspring. Malaria is caused by parasites transmitted to people through the bites of infected female mosquitoes.

The goal is to release genetically modified mosquitoes to mate with wild mosquitoes so that their malaria-blocking genes enter the gene pool and eventually overrun the population, short-circuiting the species' ability to infect people with the parasites.

"It can spread through a population with great efficiency, increasing from one per cent to more than 99 per cent in 10 generations, or about one season for mosquitoes," University of CaliforniaSan Diego biologist Valentino Gantz

said. University of California-San Diego biologist Ethan Bier called this a "potent tool in sustainable control of malaria," as all the mosquitoes in a given region would carry anti-malarial genes. "We do not propose that this strategy alone will eradicate malaria," University of California-Irvine molecular biologist Anthony James said.

But in conjunction with treatment and preventive drugs, future vaccines, mosquito-blocking bed nets and eradication of mosquito-breeding sites, it could play a major role in sustaining the elimination of malaria, James said.

Other scientists also have been working to create genetically engineered mosquitoes. One group last year said it created a strain carrying a gene leading nearly all offspring to be male, which could cause wild populations to plummet.

"In contrast, our much more flexible system only prevents mosquitoes from carrying malaria but can be used to do no harm to the mosquito. So it should generate the least amount of ecological damage," Bier said. The UN World Health Organization estimates there will be 214 million cases of malaria worldwide in 2015 and 438,000 deaths, most in sub-Saharan Africa.

The research was published in the Proceedings of the National Academy of Sciences.

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RESEARCH

Roche buoyed by early data on atezolizumab in advanced melanoma Roche is banking on atezolizumab to bring in billions in revenue by 2020 SWISS DRUGMAKER Roche released what it called encouraging early data on cancer drug atezolizumab in combination therapy for treating a form of advanced melanoma. A phase Ib study of atezolizumab (MPDL3280A), used in combination with the BRAF inhibitor Zelboraf for previously untreated BRAFV600 mutation-positive inoperable or

metastatic melanoma, showed adverse events were "manageable and generally reversible", it said.

It showed the combination resulted in an objective response rate of 76 per cent of people, including three complete responders. Roche is banking on atezolizumab to bring in billions in revenue by 2020 as a centre-piece of its strategy to counter the threat

of biosimilar versions of its older medicines with new drugs to fight cancer.

"These early efficacy re-

sults encourage us to further evaluate combination strategies of atezolizumab and targeted therapies like Zelboraf in people living with advanced melanoma, a disease which is still associated with a poor prognosis," said Sandra Horning, Head of global product development, Roche.

Roche's immune-system boosting atezolizumab, which the company hopes will win

approval for bladder and lung cancer in 2016, is one of its most anticipated prospects, along with its ocrelizumab medicine for multiple sclerosis and its ACE-910 investigational treatment for people with haemophilia.

They are expected to rake in combined annual sales of $5 billion by 2020.

Reuters

Celldex vaccine improves long-term brain cancer survival in study The latest trial results showed that 32 per cent of patients treated with Rintega, also known as rindopepimut, and Avastin, or bevacizumab, were alive after 18 months NEW DATA from a midstage trial show that Celldex Therapeutics' experimental brain cancer vaccine, combined with standard therapy, continues to improve chances of survival for patients with recurrent cancer.

The therapy, designed to enlist the body's immune system to fight glioblastoma multiforme (GBM), showed that 25 per cent of patients given Celldex's Rintega along with Roche Holding AG's Avastin were alive after two years, compared with no survivors in the group of patients given only Avastin.

Results from the 73-patient trial were presented at the Annual Scientific Meeting of the Society for Neuro-Oncology. "The long-term survival benefit observed in this study is unprecedented," Dr David Reardon, Clinical Director,

40 EXPRESS PHARMA December 16-31, 2015

Dana-Farber Cancer Institute's Center for Neuro-Oncology, and the study's lead in-

vestigator said. Rintega, which was granted breakthrough therapy designation

by the US Food and Drug Administration last year, targets a specific genetic mutation

that occurs in about 30 per cent of GBM tumors.

Currently, the median survival for such patients with recurrent GBM is about nine months, Celldex said. The latest trial results showed that 32 per cent of patients treated with Rintega, also known as rindopepimut, and Avastin, or bevacizumab, were alive after 18 months, compared with 13 per cent of those given only Avastin. Celldex has previously reported that the trial met its main goal of showing that Rintega patients were more likely to be alive after six months without their cancer worsening.

Celldex said it expects to report early next year interim results from a study of Rintega in patients with newly diagnosed GBM. Reuters

RESEARCH

Sanofi,AstraZeneca swap compounds in new twist on open drug R&D In the case of Sanofi-AstraZeneca deal, no money will change hands and both companies will be free to use the chemical compounds without restrictions FRENCH DRUGMAKER Sanofi and Britain's AstraZeneca said they had agreed a direct exchange of 210,000 chemical compounds from their respective libraries in a new twist on the drive to boost open innovation. In a bid to increase the number of leads for new medicines, and save both time and money, pharma companies are experimenting with novel ways to share earlystage research.

based on differences from those already existing in the firms' own libraries and the large volume means there will be enough for scientists to run high throughput screening tests to see if they work against a range of disease targets. That process is likely to take several years and only afterwards will promising chemicals be identified as ‘lead compounds’ to be taken forward into preclinical and eventually clinical development.

Other examples in recent years include partnership deals and the creation of consortia, often with academia, based on pooled research in certain disease areas, before the work reaches the competitive stage of developing patented medicines. In the case of Sanofi-AstraZeneca deal, no money will change hands and both companies will be free to use the chemical compounds without restrictions.

The choice of compounds was

As a result, it represents a longterm bet on a new approach to drug R&D but both sides hope it will ultimately speed up the lengthy and costly process of developing novel treatments.

"It will accelerate our ability to identify unique starting points that could become new medicines for patients,” AstraZeneca's head of innovative medicines and early development Mene Pangalos said.

Reuters

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PHARMA ALLY VENDOR NEWS

Waters ionKey/MS System bags R&D 100 Award Waters ionKey/MS System physically integrates a UPLC separation into the mass spectrometer producing up to a 40x improvement in sensitivity WATERS IONKEY/MS System has received an R&D Magazine R&D 100 Award as one of the 100 most technologically innovative products to be introduced over the past year.

Ian King, Vice President – Separations Science, Waters Division said, “The response of scientists to the product has been extremely gratifying and our development team and our collaborators deserve all the credit for bringing this product to market despite the technological challenges this novel approach presented.”

Intended for use with Waters ACQUITY UPLC MClass System and a range of Waters mass spectrometers, including the Xevo TQ-S , Xevo G2-XS and the Synapt G2-Si, the Waters ionKey/MS

Since the R&D 100 award competition began, Waters has won nine R&D 100 awards System physically integrates a UPLC separation into the mass spectrometer producing up to a 40x improvement in sensitivity, enabling scientists to achieve unparalleled separation and detection of compounds. The ionKey/MS System’s iKey Microfluidic Separation Device, which is about the size of a smart phone, contains the fluidic connections, electronics, ESI interface, column heater, eCord Intelligent Chip Technology and the 1.7 micron

UPLC grade particles packed inside a 150 micron I.D. channel to perform hundreds upon hundreds of UPLC separations reproducibly and reliably without a degradation in performance.

For quantifying extremely low abundant analytes, researchers often turn to microscale LC techniques employing microfluidics because of their ability to optimise ionisation efficiency and improve MS sampling. In their 2014 article in the journal Bioanaly-

sis, Merck scientists betatesting the ionKey/MS System reported that the method they developed achieved an overall 20-fold increase in sensitivity (0.5 picomoles vs.

11 picomoles) for endogenous levels of GLP-1 in human plasma, a faster run time (nine minutes vs. 35 minutes), increased specificity and resolution over a more traditional LC-MS/MS method.

Since the R&D 100 award competition began, Waters has won nine R&D 100 awards, most recently for its CORTECS 1.6 micron analytical columns, Oasis 96-Well (micro) Elution Extraction Plate, XTERRA Columns, ACQUITY UPLC System and the ACQUITY UPC2 System.

capabilities of our solution are being continually demonstrated by our customers. We are happy to enable the development of this biobetter, in addition to running numerous collaborations in life cycle management and new drug candidates.”

The agreement is not expected to impact Novozymes’ financial expectations for 2015.

ESSEL PROPACK has been certified by the Department of Scientific and Industrial Research (DSIR) for outstanding innovation in R&D facility for their Vasind Plant.

DSIR is a part of the Ministry of Science and Technology, which was announced through a Presidential Notification. Its main aim is to support R&D endeavours of industrial units to develop state-of-the-art globally competitive technologies and enhance the share of technology intensive exports.

Essel Propack has pioneered in tube packaging research by working towards continuous innovation and identifying various barriers and influencers that protect and enhance the shelf life of the product. The packaging offered by Essel Propack offers high standards of safety and regulatory compliances.

The DSIR recognition has been received by Essel propack for a period of three years — upto Nov 2018.

Ashok Goel, Vice Chairman and Managing Director, Essel Propack, “It is indeed a proud moment for us to receive such a distinguished recognition from DSIR for our R&D division. This recognition will encourage us to further strengthen our efforts to carryout advanced research in packaging science and create more intellectual properties.

EP News Bureau-Mumbai

EP News Bureau-Mumbai

EP News Bureau-Mumbai

Novozymes Biopharma, Paras Biopharmaceuticals collaborate to generate Teriparatide Teriparatide, a leading treatment for osteoporosis, a debilitating bone disease largely affecting women over 50 years of age NOVOZYMES Biopharma and Paras Biopharmaceuticals will collaborate to generate an improved version, a biobetter, of Teriparatide, a leading treatment for osteoporosis, a debilitating bone disease largely affecting women over 50 years of age.

“The collective strengths of Paras Biopharmaceuticals’ and Novozymes’ technical expertise will bring solutions and treatment options to help osteoporosis patients,” says

42 EXPRESS PHARMA December 16-31, 2015

Dr Hans Söderlund, Director, Global Strategic Alliance at Paras Biopharmaceuticals Finland Oy. “Novozymes’ VELTIS technology and Paras Biopharmaceuticals’ Diabrid NobleCleav technology will create a superior osteoporosis medicine,” adds Dr Ashesh Kumar, Director of Biologics and Licensing, Paras Biopharmaceuticals Finland Oy. Already well-established in the fields of diabetes,

haemophilia and neutropenia, the VELTIS platform provides once-weekly, once bi-weekly or once-monthly peptide or protein dosing. As a result, VELTIS offers the potential for enhanced patient adherence and improved therapeutic impact.

“This is further market validation of the Novozymes Biopharma’s VELTIS technology”, says Svend Licht, Director, Novozymes Biopharma. “The versatile

Essel Propack’s R&D division recognised byDSIR

Anton Paar India launches various initiatives in 2015

HyZone Class II Microbiological Safety Cabinets & HyZone Unidirectional Vertical Downflow Unit (Laminar Air Flow Unit)

It has resulted in significant growth in business volumes, team size and stable partnerships with our customers

FOUNDED IN 2009, with the objectives of enhancing stable relationships, specialisation, support, sustainable growth and a systems approach, Anton Paar India has made significant investments and launched various initiatives to further these objectives during 2015.

These positive steps are a result of significant growth in business vol-

Manufactured As Per

International Quality Standards

Microprocessor Based Monitoring Control System

‘innovation’, ‘tradition’ and ‘responsibility’ up close.

There are four demonstration laboratories in Gurgaon, Mumbai, Bangalore and Hyderabad with the full range of Anton Paar instruments and attached training rooms. This will create ideal conditions for customer training and experiencing the measurement capabilities of Anton

Ergonomic Design Which Reduces User Fatigue

Protection For Product, Operator, Environment

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During the course of 2015, offices in Mumbai, Chennai and Bengaluru have also moved to new locations and have been expanded and equipped with better infrastructure facilities

Accuracy To Meet Your Research Application

Audio Visual Alarms For Discrepancies In Operating Function

umes, team size and stable partnerships with our customers.

Anton Paar India has acquired a second ‘twin’ building next to the existing headquarters in Gurgaon and has consequently doubled the available space at the headquarters.

The new headquarter building was recently inaugurated by Dr Jakob Santner, Executive Director, Anton Paar.

During the course of 2015, offices in Mumbai, Chennai and Bengaluru have also moved to new locations and have been expanded and equipped with better infrastructure facilities.

The upgraded infrastructure will serve all parts of the company: sales, service and administration. The focus is on 'customer experiences': existing users, prospective customers and guests will be able to experience the characteristics of Anton Paar –

Paar products in the best possible surroundings.

2015 was earmarked as the 'Year of Service' globally within the Anton Paar group. Various initiatives have been undertaken at Anton Paar India towards enhancing our service support capabilities but the most significant commitment has been the increase of the service team by 40 per cent.

This future-oriented expansion has also allowed us to organise the service team in three focused regions for more qualified and focused support for our customers. Backed by in-house repair centres at Gurgaon and Mumbai and increased warehousing space for spare parts in all four regions, Anton Paar India is looking forward to deliver an enhanced support to our customers.

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Soft Touch Keyboard & Rear Lit LCD Display For Keeping Up-To-Date Records

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PHARMA ALLY

Bespak addresses India’s biopharma drive for high value drug delivery products at CPhI India 2015 The company showcases the innovative Syrina 2.25 auto-injector that brings the flexibility to design a unique form factor

BESPAK, A leading, global drug delivery company, at the recently held CPhI India 2015, utilised the internationally sponsored event to meet clients and to further highlight how its technology, in the field of combination products, auto injectors and pen injectors, can best assist the complex requirements of India based biopharmaceutical companies. To date, Bespak has built-up and established strong customer relationships with many of the country’s leading biopharmaceutical companies for a range of products from Metered Dose Inhaler (MDI) valves, injectables, respiratory devices and more.

Steven Kaufman, Bespak’s Global Business Development Lead, said, “India’s biopharma sector is on the lookout for highly innovative drug and delivery device solutions that provide a competitive edge for their products. Consequently, we are seeking to use this event to maintain our close relationships with our customers, whilst demonstrating how we can best service their needs with advanced drug delivery device technology that further increases value by helping to differentiate their generic, biobetter and biosimilar drugs.”

He continued, “For example, we will be demonstrating

44 EXPRESS PHARMA December 16-31, 2015

Syrina 2.25 utilises the standard 2.25ml prefilled syringe, based on Bespak’s proprietary VapourSoft technology how our latest addition to the Syrina product range, the Syrina 2.25, which utilises cutting- edge drug delivery tech-

nology, brings the flexibility of being able to design a truly unique form factor to the market.”

Syrina 2.25 utilises the standard 2.25ml pre-filled syringe, based on Bespak’s proprietary VapourSoft technology and will also be available in a 1ml version.

The VapourSoft powerpack system helps overcome issues seen in spring-based auto-injectors. Based on proven valve technology, a small novel container of liquefied gas serves as a new power source. The propellant, when released, provides sufficient energy, in the form of a pressurised vapour, to power drug delivery and other functions. The consistent delivery performance across the Syrina product range gives researchers and biopharmaceutical companies the ability to use Syrina with VapourSoft at a very early stage of development.

Several variations of the devices are available for clinical trials with a range of industrial designs being considered for the body of the autoinjectors to best suit patient needs. The Syrina auto injector with VapourSoft platform is proven to accommodate multiple primary containers, as well as high viscosity and high volume injections.

EP News Bureau-Mumbai

Phenomenex publishes guide on ayurvedic medicine and herbal applications The guide highlights improved methods using the latest Core-Shell technologies PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has announced the publication of a new ayurveda medicine and herbal applications guide. Available in both print and digital formats, the guide presents 58 pages of applications for all of

Phenomenex India.

The guide highlights improved methods using the latest Core-Shell technologies which significantly improves the resolution, speed, and sensitivity of complex natural product composition testing.

“From sample preparation questions, to selecting the right HPLC or GC column, we

Phenomenex also offers a selection of solutions for the analysis of natural product substances, along with application support and method development services through their PhenoLogix team the frequently requested ayurvedic and herbal compound classes using analytical HPLC and UHPLC techniques.

“Ayurveda is one of India’s most rapidly growing market segments. In line with the ‘Make in India’ Campaign, Phenomenex India completely supports the further development and regulation of the ayurveda industry, as all of the players work to build a strong global market for these unique Indian remedies,” says Nick Mitchell, Managing Director,

are seeing more customers finalising analytical methods for their ayurveda products than ever before”, notes Brad Turek, Director of Sales and Marketing.

In addition to this guide, Phenomenex also offers a comprehensive selection of solutions for the analysis of natural product substances, along with application support and method development services through their PhenoLogix team.

EP News Bureau-Mumbai

PHARMA ALLY

eClinical Solutions releases new version of elluminate The release provides advanced business intelligence capabilities to support RBM, enhanced capabilities to organise data for efficient reporting and analysis

eCLINICAL SOLUTIONS, provider of data management services and technologies, has released the latest version of their end to end clinical data repository and analytics platform, elluminate. This release provides advanced business intelligence capabilities to support Risk Based Monitoring (RBM), enhanced capabilities to organise data for efficient reporting and analysis, and new visualisations for safety signal detection and analysis. “elluminate continues to innovate and change the way the life sciences industry interacts with their clinical and operational data,” explains Robert Arnesen, President, eClinical Solutions. "Our vision is to provide a complete ‘end to end’ experience that allows all functional groups within an organisation to have on demand access to standardised data for efficient utilisation and analysis through powerful visualisations.”

"Our latest release continues to expand the library of out-of-the-box visualisations that further support centralised monitoring efforts and safety signal detection, while allowing users to organise their data utilising CDISC SDTM and ADaM for streamlined reporting and submission," says Raj Indupuri, Chief Executive Officer, eClinical Solutions. In addition, elluminate provides standards governance, metadata management, and document management capabilities in a cloud based 21 CFR Part 11 compliant environment.

"What we are doing is exciting," Indupuri stated, "we see the results every day as our customers utilise and leverage one of their most valuable assets, their clinical data,

elluminate is a breakthrough technology built specifically to help the life sciences industry aggregate and standardise disparate data from multiple sources, and allows users to perform powerful analytics across trials through the use of elluminate." elluminate is a breakthrough technology built specifically to help the life sciences industry aggregate and standardise disparate data from multiple sources, and allows users to perform powerful analytics across trials. "We understand the inherent struggles in collecting and leveraging clinical research data. Our understanding of the clinical development process coupled with our passion for creating innovative technologies shapes and drives our mission to make clinical research data acquisition, standardisation, aggregation, and analytics absolutely simple and easy," says Indupuri.

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TAKE Solutions launches PVIndia The network is aimed at providing a forum for the pharmaceutical industry TAKE SOLUTIONS has launched PVIndia,a unique pharmacovigilance peer network, organised and managed by one of TAKE’s Life Sciences division, Navitas.

The benefits of nets community are open network and innovation, connection with 102 companies and 300+ global safety leaders, discussions on latest global regulatory and industry insights, peer exchange, quantitative and qualitative performance benchmark.

In continuance of its efforts to establish itself as a life sciences thought leader, TAKE Solutions has launched ‘Nets’ in India. The network is aimed at providing a forum for the pharmaceutical industry to mutually discuss and ideate onsolutions for challenges faced by them in the export market. PVINDIA is an exclusive membership based network of emerging global

PVINDIA is an exclusive membership-based network of emerging global pharma companies from India. The network will provide a bi-annual neutral forum for heads of safety and PV leadership of global pharma companies to debate the latest subjects of interest and collaboratively generate insights on regulatory issues pharma companies from India.

The network will provide a biannual neutral forum for heads of safety and PV leadership of global pharma companies to debate the latest subjects of interest and collaboratively generate insights on regulatory issues. Besides providing complimentary membership and access to pvtech for PV

Heads of Information Technology, the platform will provide peer-to peer-comparison of PV productivity data to set new standard for the PV system in India. Furthermore, with the membership of 102 and 300+ global safety leaders participating in a year, the networks aids in exploring the value of Indian PV system in the global

market. With a wide range of membership, the underlying objective of the network is to benchmark the best industry practices.

Ram Yeleswarapu, President and Chief Executive Officer, TAKE Solutions said, “We are excited about spearheading this first-of-its kind network in India. Whilst we be-

lieve that drug safety can be a source of competitive advantage, we see greater mutual benefit in the sharing of experience. Through our pharmacovigilance networks; pvnet, pvconnect, pvtech, and pvindia, our vision is to shape the future of pharmacovigilance by providing PV leaders with an environment to meet and discuss alternative solutions with other industry thought leaders for the benefit of the industry as a whole.” He further added, “As a life sciences technology services provider company, it is part of our DNA to deliver services that will aid in innovating solutions for the escalating challenges in the pharma industry. As we come together to form a community, we look forward to fostering collaboration through our network."

EP News Bureau-Mumbai

Ashland aids pharmaceutical manufacturers with formulation services Company showcases pharmaceutical formulation services at CPhI India PHARMACEUTICAL scientists at Ashland were present during CPhI India to explain how Ashland is providing formulation services to manufacturers in the region that require assistance in tailoring polymer-based drug delivery systems for optimal bioavailability, stability and patient compliance.

"The pharmaceutical market in India is now the third largest in the world,” said Nelson Corda, General Manager, Rest of Asia, Ashland Spe-

46 EXPRESS PHARMA December 16-31, 2015

cialty Ingredients. “Last year, Ashland opened a pharma center of excellence in Hyderabad to conduct oral solid-dosage form research and to assist manufacturers with novel therapeutics through polymeric drug delivery systems. With this facility, we recognise the importance and vitality of the Asia Pacific pharma market and the particular relevance of India within this market.”

Ashland showcased a

series of polymer excipients that enable manufacturers of oral dosage forms to produce finished products with relative ease and efficiency.

Among the products on display will be Klucel hydroxypropyl cellulose (HPC), a premier tablet binder that makes tablet preparation easy. Polyplasdone crospovidone, a super disintegrant for immediate-release oral dosage forms, will be presented as a core technology proven to enhance

dissolution.

Natrosol hydroxyethylcellulose (HEC), a non-ionic water-soluble cellulose ether, will be spotlighted as a technology to control the rheology of solutions and gels. AquaSolve hypromellose acetate succinate (HPMCAS), a solid dispersion polymer, will be presented as a novel technology for bioavailability enhancement of poorly soluble active pharma ingredients. Direct compression grades of Benecel hypromellose will be of-

fered as a technology to control the release of complex drug molecules in soliddosage forms.

“Ashland brings to India an unparalleled excipient portfolio and a global research and development (R&D) team focused on all of the major formulation trends,” said Thomas Durig, Senior Director, Pharmaceutical and Nutrition Specialties R&D, Ashland Specialty Ingredients.

EP News Bureau-Mumbai

PHARMA ALLY PROFILES

The UEC: Leaders in pharma packaging machinery manufacturing since 1963 THE UNITED Engineering Company (UEC) with the brand name 'UNITED' is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care. With the founder's innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has also expanded its footprints abroad in a large way. Today, 'UNITED' machines are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, United Arab Emirates, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their research and development and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, 'UNITED' ma-

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PHARMA ALLY

chines provide technically advanced solution for its customers.

Presently, UEC is having its head office at Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having another office at Mumbai along with a service station.

The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development.

Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost

48 EXPRESS PHARMA December 16-31, 2015

effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focused on being a corporate citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events which help in uplifting the quality of living of the deprived.

With almost every pharma formulation manufacturer being an 'UNITED' machine user coupled with over 50 years experience, UEC commits in becoming better than the best in the near future.

Founder: GD Roy (R)

PHARMA ALLY

NEOMACHINE MFG.CO.: Aleader in automatic coating technology Kolkata-based Neomachine MFG CO was started in 1973 with an objective of manufacturing all types of pharmaceutical machinery. For a decade, the company catered to the requirements of the Indian pharma companies in injectable, liquid, tablet, capsule and ointment sections machinery.

'While catering to this market segment, Neomachine happened to come across a Kolkatabased pharma producer, who were facing problems in film coating of tablets. Until then, the tablets were being coated in conventional pans, which were not only causing health hazards to the coating personnel, but was also a time consuming process.

Inspired by this opportunity, Neomachine started the process of developing an automatic coat-

ing machine in the right earnest.

After, two years of research and development, the first 'Neocota Automatic Coating System' was manufactured in 1984.

During the last three decades, Neomachine manufactured and marketed over 550 machines, out of which 100 machines were exported to the countries like the US, Australia, China, Jordan, Yemen, the UAE, Uganda, Kenya, Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh, etc.

Neomachine, a professionally managed organisation now has two manufacturing units in Kolkata, which are equipped with state-of-the-art equipment like fabrication, machining, assembling, finishing and other related jobs.

The company has been

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Anup Maitra, Managing Director, Neomachine

strictly following all the quality control guidelines during manufacturing. The bought-out items are inspected at the manufacturers' works periodically. The company has dedicated team of engineers for providing erection and commissioning and prompt after-sales service to the clients.

The in-house R&D facility is abreast of the latest technology upgradation and the latest developments in 'coating technology'.

This helps in continuous improvement of the product.

Neomachine also provides DQ/IQ/OQ/PQ qualifications for automatic coating system and are in the process of getting CE Certification. Over the years, the company has gained vast experiences in manufacturing ‘automatic coating system’ by interacting with various Indian and multinational pharma and confectionery units based in India.

Products like Cadbury India’s fast-moving product ‘Gems’ and Parke Davis’ ‘Chicklets’ are coated in the systems manufactured by Neomachine. The company also impart aqueous and non-aqueous film coating and

sugar coating technology to clients, who need the same expertise.

Neomachine also supplies Hepa Filter for filtration of incoming drying air and mobile bed wet scrubber for purification of exhaust air, for these companies that need these items.

Neomachine, being a singleproduct company, manufacturing various models of Neocota.

The automatic coating machine, gained vast experience in coating technology since the last two decades. Neocota is designed to comply with current US FDA and other international legislation as well as anticipated trends. The improved and flexible design enables Neocota to perform in national and overseas environment without any system modification.

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PHARMA ALLY PRODUCTS

I Holland showcases innovative new product developments at PMEC India I HOLLAND, a leading manufacturer of tablet tooling for the pharmaceutical and nutraceutical industries, recently showcased its two innovative new products launched this year at PMEC India.

I Holland introduced XDF (eXtended Dwell Flat) a novel patented elliptical head form which has been designed to increase dwell time on an existing press without the need for expensive modifications. XDF gives users higher press speeds for challenging products and formulations and also enhances tablet compaction and cohesion. It can increase dwell time by up to 50 per cent over a standard punch head allowing more

IH-TMS

dwell than a D-type punch on a B-type tool. This increase helps to solve compression problems without upsizing punches or investing in a new press.

IH-TMS is a stand-alone system which allows tablet manufacturers to keep a record of tablet quantities by number of tablets, work order or batch in-

formation to ensure production is run efficiently. In addition it has the capability to archive tablet and tool images and drawings.

Available in any language and with an easy to use touchscreen interface, it incorporates an alarm to alert users of any problems including over compression, tooling replacements or if maintenance is required. It has been created for manufacturers to have a complete audit trail on production, an important process in tablet manufacture.

Contact details Clare Taylor Marketing Manager, I Holland Limited Registered

XDF

Office Meadow Lane, Long Eaton, Nottingham, NG10 2GD, England Telephone: +44 (0) 115 972 6153 Fax: +44 (0) 115 973 1789 E-mail: info@iholland.co.uk Web: www.iholland.co.uk

Debug Services launches ImageCompare DEBUG SERVICES has launched inspection software ImageCompare from Ladegast, Germany for the Indian market.

Quality inspection of printed packaging is a huge challenge for most pharmaceutical and printing companies around the world. It is often done manually. This method is extremely time consuming and lends itself to a great margin of human error. With over 20 years of experience, Ladegast is proud of its history as the pioneers in quality control and inspection solutions. As a printing company with over 60 years of experience in pharma packaging solutions, Ladegast

50 EXPRESS PHARMA December 16-31, 2015

is constantly developing ImageCompare to the up-to-date regulations and technology. Their software ImageCompare is widely used by pharma manufacturers, food and consumer goods manufacturers, printing and packaging, etc. Fortune 100 companies worldwide rely on Ladegast to help them bring their packaged products to market quickly, accurately and efficiently.

The inspection software ImageCompare operates on a pixel-basis, language independent, using advanced comparison technology. Hence it ensures that possible deviations (in text, barcodes, Braille, artwork) are detected accu-

rately at every stage of the production process. It is easy to use, flexible and reliable (For example any Asiatic pharma leaflet with the format XXL, which cannot be inspected with the eye, can be checked accurately with the ImageCompare Software within only a few minutes).

A major advantage of the

solution is in fact the sensitivity issue. The degree of sensitivity, as far as detecting differences goes, can be adjusted based on the unique needs of the organisation.

Ladegast is the only provider that can offer this degree of flexibility and offer such highlevel custom solutions.

The company Ladegast and

the development of ImageCompare are certified of having implemented and maintaining a quality management system which fulfils the requirements of DIN EN ISO 9001:2008. ImageCompare fulfils the requirements of FDA 21 CFR Part11.

Debug Services also offer complete validation services from documentation to execution for pharma customers.

Contact details Darshan J Divecha +91 98 20 10 81 82 Debug Services Mumbai, Maharashtra www.debugservices.com E-mail: darshan@ debugservices.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

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Super Oxidized xidized x i d i d Solution H which Heals & Cures Microdacyn is the international ernational brand name for er or wound care products based on Microcyn Technology, Technology, developed developed by b Oculus Innovative Sciences USA. Microdacyn daacyn acy occupies a special sp sp position within the category of wound woouund treatment reatm products.

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PHARMA LIFE I N T E R V I E W

‘Make in India’ initiative could be huge re-branding opportunity Pharma cos need people who are Indian at heart, with global expertise in tech ops says Ian Wilcox, Global Managing Director, Life Sciences, HayGroup as he spells out some growth strategies to Viveka Roychowdhury

Adhering to global standards, be it GMP or GCP, has been a recurring concern in India. How are managements of pharmaceutical companies addressing this issue?

Scrutiny of global regulators like the US FDA has increased and we are seeing an increasing number of warning letters. Over the last 10 years, FDA activity has increased noticeably. The FDA issued more than six times the number of warning letters for manufacturing in 2014 (19) than it issued in 2005 (three).

But this spike in warning letters doesn’t tell the whole story. According to various media reports, between 2010 and 2011, field alert reports nearly doubled from approximately 800 to slightly less than 1600. In that same period, OTC recalls rose from 336 to 652, while prescription drug recalls rose from 479 to 605. Drug shortages also climbed: from 178 shortages in 2010 and 251 in 2011. In this same period, shortages of sterile injectables more than doubled, from 74 to 183.

These figures are for all FDA activity, not just FDA activity related to India specifically.

As I see it, the ‘Make in India’ initiative could be a huge re-branding opportunity for the Indian pharmaceutical industry. As for how managements of pharma companies are addressing this issue, I think they should do it

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at three levels. Firstly, they should ensure that they have professionals with sound technical operations (tech ops) skills of the pharma manufacturing processes at the board level. This immediately sends out a strong signal to global regulators like the US FDA that the company has sound tech ops expertise, right at the top level.

Secondly, they should hire professionals with these tech ops skill sets like Sigma 6, Total Quality Management, ISO 9001, or Company-Wide Quality Control from global companies which have gone through manufacturing change of this nature. For instance, they should hire from companies like Boehringer Ingelhiem, Novartis, Sandoz.

Thirdly, the approach to quality should change. The pharma industry still sees quality as a cost, which is why quality suffers during cost cutting measures. Pharma sees quality as an afterthought where as in industries like automobiles, it is seen as a strategic asset. The pharma industry is beginning to view quality as a means to achieve cost efficiencies but they are still not seeing it as a key strategic asset. In fact, many of the bigger contract manufacturing organisations (CMOs) do a better job and have a better approach to quality than pharma companies.

What advice do you give to global companies who have acquired Indian companies and are strategising to bring India operations in line with global practices, be it GMP or GCP, etc?

It is both an attitude and skill set issue. On the attitude front, managements of acquiring companies cannot come in with an expat strategy. It should be a shared process, with the senior management of the acquired company on board and completely part of the process.

An attitude of shared accountability has to be built in all the way down the line, to the manufacturing shop floor, packaging lines etc. This requires a mindset that tracks key quality parameters like 'getting it right the first time, on time', reducing error rates, reducing deviations from good manufacturing practices, ensuring the integrity of test data, and ensuring sufficient environmental monitoring.

Each and every employee has to own it and take shared accountability. This requires companies to hire people with the best skill set as well as the right attitude, that (quality) is not just a part of the job but a part of the shared accountability. Pharma companies need to find people who are Indian at heart, with global expertise in tech ops.

Regarding the second issue of skill sets, India does have a dearth of talent on the pharma

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PHARMA LIFE tech ops side but this can be met by locating manufacturing plants close to talent pools. In fact, I would say that the Indian pharma industry has so far missed the opportunity to take leadership in identifying talent early and partnering with engineering schools to build a feeder pool of the skill sets they require.

Again, the auto industry has done well on this front. For instance, take the General Motors Institute in the US. Globally, the biotechnology industry has done this better and there are many industryacademia partnerships.

Within the pharma industry too there are some companies which have gone this route. Examples of industry/academia partnerships tend to be R&D rather than manufacturing focused. For example, the University of Limerick in Ireland’s Synthesis & Solid State Pharmaceutical Centre (SSPC) has collaborated with industry to optimise pharmaceutical processes.

GSK took masters students in Biomedicine or Medical Biotechnology students at

The Indian pharma industry has so far missed the opportunity to take leadership in identifying talent early and partnering with engineering schools to build a feeder pool of the skill sets they require

Lancaster University to its Ulverston site to learn more about the manufacturing process of medicines. Bayer has partnered with Peking University to create a joint research center at the school called the Bayer HealthCare/Peking University Center of Translational Research for Drug Discovery.

Boehringer Ingelheim teamed up with the Duke Clinical Research Institute, an academic affiliate of the Duke University School of Medicine, to better understand the progression of the idiopathic pulmonary fibrosis (IPF).

Teva in Israel has a partnership with the UK Cancer Research Institute.

Sanofi has committed $2.4 million per year to seven top

academic centers, including Johns Hopkins, Brigham and Women’s Hospital, and Columbia, to fund about 20-25 seed projects annually, with no strings attached and a wideopen scope.

It is clear from the recent moves of Sun Pharma to acquire Novartis’ brands in Japan or Dr Reddy’s Laboratories acquisition of some of UCB’s brands, Strides Arcolab buying local J&J brands that some of the bigger Indian pharma players are looking at topping the charts as global branded generics players.

What are the starting blocks they need to put in place now, so that by 2020 they would have evolved to the

next level?

To become truly innovative, Indian pharma companies will need to hire talent with this experience. This may not be possible for all companies, but it is definitely possible for some of the bigger top players.

The pharma sector in India has seen significant growth over the last few years but it remains generics-focused.

What strategies can they employ to evolve up the value chain?

Within the Indian pharma sector, there are two strategies that I’d like to discuss: firstly, focusing on underserved areas of the world, and secondly, continuing to strengthen India’s position as a

logistics hub.

With respect to India’s continuing focus on underserved areas of the world, it should develop core competencies in disease areas that meet a broad population need. Example areas are respiratory, HIV/AIDS, and anti-infectives.

With respect to strengthening India’s position as a logistics hub, India sits, geographically, at the crossroads of the world and therefore should continue to invest in infrastructure.

Companies should make logistics excellence a priority, because logistics supports another core competitive advantage for India: manufacturing. India needs to continue to work for excellence in manufacturing as it carries out a strategy of delivering medicines to underserved areas. India should continue to be a platform for manufacturing APIs and generics, and to be sure, will continue to address the quality issues that have bedeviled this critical sector. viveka.r@expressindia.com

APPOINTMENT

TAKE Solutions names Raman Kapur as Independent Director US-based Raman Kapur brings pharma and generics expertise to TAKE board TAKE SOLUTIONS has appointed a new Independent Director, Raman Kapur who is a pharma veteran based out of the US. With a global experience of over 40 years, he served as non-executive Chairman of Transition Patient Services, a medication management and distribution company.

Kapur joined ScheringPlough as a financial analyst in 1975, serving in progressively more responsible finance, marketing and general

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management positions in the US and internationally in Europe, the Middle East, India and Latin America. Before taking over as President World-wide Generics, he served as President of Schering-Plough’s Global Animal Health business. He also served as President, Warrick Pharmaceuticals, USA. Additionally, Kapur holds multiple directorship roles, serving as Chairman of the World India Diabetes Foundation, a Board member of Mc-

Carter Theater in Princeton, New Jersey, and the American Cancer Society of Central New Jersey. He has previously served on the Board of Directors of the European Generic Association in Brussels, Belgium, as well as the Generic Pharmaceutical Association in Washington, DC, the Capital Health System in Trenton, New Jersey, the Princeton Area Community Foundation, and the Center for Advanced Study of India at the University

of Pennsylvania.

A graduate of the Phillips Exeter Academy, Exeter, New Hampshire, Kapur received a BA degree in economics from Columbia College, New York and an MBA degree in finance and international business from Columbia University, New York. His areas of interests cover healthcare, education and social and economic development in the developing economies.

EP News Bureau-Mumbai

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