Express Pharma (Vol.11, No.20) August 16-31, 2016

VOL. 11 NO. 20 PAGES 92

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Market Conference on pharmacovigilance held in Mumbai

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CONTENTS Vol.11 No.20 AUGUST 16-31, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap New Delhi

Sikkim The potential pharma hub

Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar Arun J Debnarayan Dutta E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

Thanks to the North-East Industrial and Investment Promotion Policy (NEIIPP) 2007, Sikkim has been able to offer a host of tax benefits to the industry.Thus it is no wonder that the state has already attracted an investment of over $400 million from 22 major pharma companies in the last three years. At this pace, the state could emerge as a major pharma hub in the North Eastern region by 2018 | 22 P26: REPORT VTE therapeutics market set to hit $3.7 billion by 2025: GlobalData

P37: INSIGHT Challenges in serialisation programme and best practices

P39: VENDOR NEWS Spectrum Pharmatech Consultants with RAAJ GPRAC form consortium

MARKET

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CONFERENCE ON INNOVATIONS IN FORMULATION AND DRUG DELIVERY HELD IN MUMBAI

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CONFERENCE ON PHARMACOVIGILANCE HELD IN MUMBAI

PHARMA TECHNOLOGY REVIEW

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HOW SECURE IS YOUR DATA?

RESEARCH

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EXPERIMENTAL VACCINE COULD PROVIDE RAPID RESPONSE TO DISEASES

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FLU VACCINE MAY HELP KEEP DIABETICS OUT OF THE HOSPITAL

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TAURX ALZHEIMER’S DRUG FAILS IN LARGE STUDY

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BRISTOL-MYERS’ OPDIVO FAILS LUNG CANCER TRIAL

P81: INTERVIEW Biocon is committed to address the skill gap that exists in the industry today

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

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

EDITOR’S NOTE

Testing the new FDI norms

T

he Modi government’s reforms have tinkered with FDI norms twice, first in November 2015 and more recently in June this year. As a safeguard against price escalation and monopolies, the previous FDI policy for pharma allowed 100 per cent FDI under automatic route in new (greenfield) pharma projects but investors needed government approval for existing (brownfield) projects. In June this year, the government allowed FDI in existing pharma facilities up to 74 per cent under the automatic route, with government approvals required beyond this level.

The new FDI norms will now be tested for the first time, as the recently announced Fosun Pharma-Gland Pharma deal goes for approval.

Chinese Fosun Pharma announced it would buy a controlling 86 per cent stake in the Hyderabadbased Gland Pharma for approximately $1.26 billion. With the transaction pegged to be the largest acquisition of an Indian company by a Chinese firm, the deal has multiple layers of complexity.

Firstly, all engagements with China need to be scrutinised from a security point of view. While this could well play out to be a modern take on the Hindi-Chini bhai bhai story, past history does not allow us to take anything for granted.

Secondly, the Indian pharma industry is dependent on China for key APIs but this deal will not raise the same concerns as a majority of Gland Pharma's revenues come from exports. Thus the deal should not impact supplies in the domestic market, according to industry observers. In fact, the deal could expand Gland Pharma's reach and

The new FDI norms will now be tested for the first time, as the Fosun Pharma-Gland Pharma deal goes for approval

export revenues, say market observers. Fosun Pharma's interest in the Indian company is easy to explain, given the global shortage of injectables and the chase to acquire reliable injectable manufacturing facilities. Gland Pharma was in fact the first injectable drug manufacturer in India to be approved by the US FDA and also has GMP certification from other global regulators.

In other words, it has built up considerable brand value globally and is a prize catch.

The Fosun Pharma-Gland Pharma deal will now have to vend its way for further clearance to the Foreign Investment Promotion Board (FIPB) and the Competition Commission of India. As industry insiders point out, the process could continue for a few months, even till October, as most of these Boards, like the FIPB, meet just once a month.

Will the Narendra Modi government use this FDI transaction to burnish its brand image as a truly ‘liberalised’ nation, firmly on the path of economic reforms? This deal could see the government provide clarity on its evaluation criteria for acquisitions over 74 per cent and a host of other nitty-gritties which were left ambiguous.

Policy makers obviously need to keep a much larger picture in mind: balancing the socioeconomic realities of Bharat with the corporate aspirations of India. All in all, while Brand India Pharma has proved its sterling worth, it is now the turn of policy makers to follow through.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET POST EVENT

Conference on innovations in formulation and drug delivery held in Mumbai The two-day conference discussed various innovations in the pharma formulations and its relevance in today's world Usha Sharma Mumbai

A

conference on Innovations in Formulation and Drug Delivery was recently held in Mumbai. The two-day long event focused on improving drug performance and therapeutic impact through enabled formulations and more effective delivery methods. Various innovation techniques in pharma formulations were discussed during the conference.

Prof Ambikanandan Misra, Professor of Pharmacy, MSU, David Sadler, President and CEO, Zotek KL, Dr Vinod P Shah, Pharmaceutical Consultant, Former US FDA, Dr Devaraj Rambhau, Technical Director, Pulse Pharma, Dr Saeed Qureshi, Principal, PharmacoMechanics, Dr Rajan Verma, Associate Director, Perrigo, Dr Muhaned AI- Hindawi, Former Senior Pharmaceutical Assessor, MHRA, Dr Saranjit Singh, Head of the Department of Pharmaceutical Analysis, NIPER and Babus KS, Head Regulatory, Hospira, A Pfizer company, were the key speakers at the event.

Shah talked about the importance of dissolution studies in alcohol. As in many developed countries, people are likely to consume alcohol after taking medicines. He also informed that this study has been recently introduced by regulators.

While talking about the biopharma classification system, he mentioned that it is a drug development tool to justify biowaivers in conjunction with the dissolution of the drug product. In the US, the highest strength of pH is taken for solu-

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The two-day long event focused on improving drug performance and therapeutic impact through enabled formulations and more effective delivery methods bility study, whereas the same is not the case in Europe. He also informed about the genesis of biowaiver monographs and mentioned that so far, more than 45 biowaivers monographs ranging from BCS class 1-4 have been generated. These have been prepared and published in J Pharma Science and are available on the FIP web page. The project was initiated by the International Pharmaceutical

Federation interest group.

Rambhau shared technical information about the application of nanotechnology in formulation of oral dosages. He feels that nano-enabled drug delivery system will be the only way forward for developing countries like India. In his presentation, he touched upon regulatory guidelines for nanosimilars and nanogenerics. He also emphasised that nanoparticles

require intense high tech instruments and no regulator will allow companies to conduct a test without or less competence of this.

Qureshi delivered a detailed note on developing and validating discriminatory drug dissolution test and profiles. He asked the audience to explain what is a discriminated test and how to conduct discriminated dissolution tests? He informed

that a drug dissolution test is conducted to assess drug release characteristic of tablets/capsules.

Verma talked about the 505 (b) (2) approval pathway considering NDAs, 21 CFR 314.108 and 314.108 exclusivity.

A workshop was also organised on the second day of the conference. u.sharma@expressindia.com

MARKET

Conference on pharmacovigilance held in Mumbai It brought together drug safety experts from the lifesciences industry with an aim to discuss pharmacovigilance issues that are unique to India INDIAN Pharmacovigilance Day conference was recently conducted in Mumbai. The oneday event was organised by Italy-based conference-producing company EasyB srl, in succession to the ‘Pharmacovigilance Day’ series of conferences conducted across Europe. It was chaired by Dr J Vijay Venkatraman, Managing Director and Chief Executive Officer, Oviya MedSafe, and a pharmacovigilance expert.

The ‘Pharmacovigilance Day’ conference brought together drug safety experts from the lifesciences industry: pharma companies, biotechnology firms, academic research and so on, with an aim to discuss pharmacovigilance issues that are unique to India. The topics at the event ranged from the current status of clinical trial safety, emerging postmarketing drug safety regulations, varied types of pharmacovigilance operations etc.

The conference began with an address by Venkataraman, who welcomed the attendees and elaborated on the objectives of the conference. He highlighted the importance of such an event in the current Indian scenario and emphasised on the need for promoting pharmacovigilance awareness among all stakeholders. Dr Arun Bhat, Consultant, Clinical Research & Development was the keynote speaker at the event. His session, ‘Clinical Trial Safety in India – Are we at crossroads?’, was on ensuring pharmacovigilance in clinical trials to revive the industry in India, the current challenges and the road map to overcome them.

Moin Don, Chief Executive Officer and Founder, PVCON Pharmacovigilance Auditing & Consulting Services was the next speaker at the conference.

He dealt with the topic, ‘A Decade of Global Pharmacovigilance Operations in India – Achievements & Learnings’.

The third session was a colloquium on the Pharmacovigilance Programme of India with

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The topics at the event ranged from the current status of clinical trial safety, emerging postmarketing drug safety regulations, varied types of pharmacovigilance operations insights from different stakeholders. Dr Deepa Arora, Vice

President and Global Head – Pharmacovigilance & Risk Man-

agement, Lupin gave insights on the various initiatives undertaken at her organisation to promote pharmacovigilance.

Dr Renuka Munshi, HoD of Pharmacology, TN Medical College, Mumbai, gave an overview on the measures taken by the public hospitals to spread awareness about drug safety and improve ADR reporting, but also detailed the challenges in doing so.

Gauri Kamath, Pharma and

Healthcare Commentator, acted as the patients’ representative and highlighted how essential it was to educate the consumers about drug safety, reporting adverse drug reactions etc, to ensure pharmacovigilance.

Dr Jamal Anwar Baig, Global Safety Country Leader, MSD Pharmaceuticals, spoke on the pharmacovigilance programme in India and recommended better cooperation between stakeholders to improve the current scenario in India. Venkataraman moderated the event. The first post lunch session dealt with the benefits and challenges of setting up an in-house pharmcovigilance unit. Geeta Shanbagh, Deputy General Manager, Pharmacovigilance & Medico-regulatory Affairs, Ipca Laboratories, shared her experiences of setting up pharmcovigilance operations in a generic pharma company.

The next session was by Shefali Gupta, Head of Strategic Initiatives – Lifesciences, Business Process Services, Tata Consultancy Services. She spoke on, ‘Building large scale outsourced pharmacovigilance operations in India”. Dr Baig gave insights on the pharmacovigilance activities at the Indian units of global firms. He also drew parallels between the methods adopted at local Indian firms and MNCs. Dr Arani Chatterjee, Senior Vice President, Clinical research, Biological E, in his session, explained the differences in managing vaccine safety and drug safety. Challenges in pharmacovigilance of biosimilars were detailed by Dr Dhanraj E, Pharmacovigilance Lead, Biocon. The last session of the day was addressed by Dr Ravindra Kumar, Manager, Clinical Safety, Abbott Vascular who spoke on the practices adopted at medical device companies.

The conference ended with a vote of thanks by Venkataraman. The event was well received by all the attendees.

EP News Bureau-Mumbai

EVENT BRIEF AUGUST TO NOVEMBER - 2016 21

PharmaTech Expo 2016

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Unannounced Audits

PHARMATECH EXPO 2016

this common platform.

Date: August 21-23, 2016 Venue: Ahmedabad Summary: The fourth Edition of PharmaTech Expo 2016, will be concurrently held with the second edition of Pack & Printech Expo.

PharmaTech Expo 2016 will be an international exhibition on pharma, lab and packaging equipment. It will provide immense opportunities to suppliers, manufacturers, industrialists, buyers, and consultants to assemble at

Contact details Aarjav Shah PharmaTechnologyIndex.co m (A Division of KNS Group) Tel: +91 – 79 – 27540493 / +91 – 79 – 40306340, 879616665 E-mail: expo@pharmatechnologyindex.com / events@ knsmedia.com Web: www.PharmaTechExpo. com/ www.PackPrin TechExpo. com /

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unannounced audits.

UNANNOUNCED AUDITS

Contact details: E: Drashti.shah@ubm.com T: 91-22-61727381

logistics solution providers to create avenues for better pharma supply chain solutions and infrastructure for the pharma industry.

7TH ANNUAL PHARMA SCM

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

Date: August 29 - 30, 2016 and August 31 - September 1, 2016 Venue: The Westin- Mumbai and The Park- Hyderabad Summary: The event will be a practical guide with highly qualified workshop trainers who are well qualified to provide unique insights and authoritative debate around techniques and strategies for preparing and handling

Date: September 1 - 2 Venue: Mumbai Description: 7th Annual SCM Pharma Confex will be the biggest conglomerate of supply chain experts from leading Indian pharma companies and supply chain and

FACILITY DESIGN Date: September 8 - 9, 2016 Venue: Hyderabad Description: A industry workshop crafted for understanding and identifying the

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EVENT BRIEF CPHI PRECONNECT- DAY ZERO

factors necessary to build efficient pharmaceutical biopharmaceutical manufacturing facilities.

Date: November 17, 2016 Venue: Mumbai Description: CPhI's Pre Connect Congress will bring together thought leaders under one roof to discuss on the latest trends and advancements in the Indian pharma industry.

Discussions will be held on key topics such as M&A, regulatory challenges, drug discovery and other critical topics which are a burning issue in the pharma industry.

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

CGMP WORKSHOP Date: September 19 - 20, 2016 Venue: Mumbai Description: CPhI is announcing for the first time ever a ‘cGMP workshop’, a two-day practical training to be conducted by a former US FDA drug investigator. The workshop will guide companies prevent instances of contamination, mix-ups, deviations, failures and errors to successfully meet the desired quality standards.

Contact details: E: Purvai.gupta@ubm.com T: 91-22-61727077

HEALTHCARE SENATE Date: September 22-24, 2016 Venue: Hyderabad Summary: Healthcare Senate, the national private healthcare business summit will host the game changers, path finders and and opinion leaders of the healthcare industry, to facilitate sharing of innovative ideas and experiences, and convert them into reality.

The event will see a largest gathering of India’s most influential healthcare practitioners; CEO/CFO/MDs of hospital chains, medical superintendents, hospitals owners and decision makers, owners of single specialty hospitals, owners of diagnostic and other healthcare centres, hospital administrators, HoD of medical and bio-medical departments, HoD of engineering and operations, medical directors, purchase managers, healthcare consultants, project heads, biomedical engineers, dealers and distributors, thought leaders, industry stalwarts and domain experts

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Contact details: For delegate registrations Vinita Hassija Mobile: +91 9820590053 Email: vinita.hassija @expressindia.com Shilpa Chaurasia Mobile: +919892170209 Email: shilpa.chaurasia @expressindia.com For awards Raelene Kambli raelene.expressindia @gmail.com

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

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

CSV WORKSHOP Date: October 6 - 7, 2016 Venue: Mumbai Description: A two-day in depth workshop designed to provide unique insights and authoritative debate into CSV models, validating data

integrity, CSV metrics, network validation and cloud validation.

Contact details: E: Purvai.gupta@ubm.com T: 91-22-61727077

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

ANALYTICA ANACON INDIA AND INDIALAB EXPO 2016

BIOSIMILARS CONGRESS INDIA 2016 Date: October 13 – 14, 2016 Venue: Hyderabad Description: Biosimilars Congress India 2016 will aim to provide strategic solutions to key issues faced by the manufacturers around the regulatory guidelines of FDA, EMA, upstream, downstream processing, identifying critical quality attributes and statistical approaches to demonstrate biosimilarity.

Contact details: E: Drashti.shah@ubm.com T: 91-22-61727381

PHARMA DATA INTEGRITY, REGULATORY AND QUALITY CONFERENCE Date: October 18 - 19, 2016 Venue: Mumbai Date: October 20 - 21, 2016 Venue: Hyderabad Description: CPhI's 3rd Annual Data Integrity, Reliability and Quality Metrics a case study- led two-day workshop will cover the latest draft guideline on quality metrics and critical topics related to overcoming data integrity issues.

Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest trade fair for the analysis, laboratory-technology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent.

At the analytica Anacon India and India Lab Expo Conference, scientists from around the world will present their innovative analysis solutions.

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PHARMA CONFERENCE SERIES Date: November 3-4, 2016 November, 2016 Venue: Mumbai Description: A strategic conference series that will address the most critical issues in pharmaceutical and biopharmaceutical manufacturing in India Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

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CPHI AND P-MEC INDIA Date: November 21 – 23, 2016 Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the latest trends and innovations the market has to offer. CPhI India is also co-located with P-MEC India, the pharma machinery show in Asia.

This year, the expo has grown from a three day exhibition to a show spanning a week, Pharma Week, (November 17 to 23, 2016). The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and recognition in the field of pharma. With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI & P-MEC 2016 will include exhibitor showcase, innovation gallery, speed meetings, live entertainment and much more.

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cover )

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(

THE MAIN FOCUS

Government of India’s great push for pharma SEZs is now facing headwinds due to adverse tax changes like the imposition of MAT and DDT. However, industry experts still believe that SEZs are pivotal to the ‘Make in India’ initiative

BY PRATHIBA RAJU

T

he role of special economic zones (SEZs) in Indian pharmaceutical industry has been a mixed bag. Ten years ago, the launch of SEZs for the pharma sector was hailed as a panacea for all the ills that plagued the sector. The momentum however dipped due to various issues like land acquisition, relocation of companies, qualms on creation of employment, uneven economic growth and imposition of Minimum Alternate Tax (MAT) and Dividend Distribution Tax (DDT).

Inspite of these obstacles, many big as well as mid and small pharma companies decided to jump on the SEZ

bandwagon. They are optimistic that the Government of India’s ‘Make in India’ initiative will breathe a new life into SEZs and pharma SEZs as well. In fact, according to media reports, the Ministry of Commerce and Industry has asked the Ministry of Finance to allow companies within SEZs to sell products in the domestic market at free trade agreement rates for promoting manufacturing in the country.

“The government has been bolstering its efforts to promote the development of SEZs in the pharma sector. Owing to tax benefits and SEZ developments, the pharma industry has been contributing a premier share of exports compared to other sectors. The

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ratio of conversion from ‘formal approvals’ to the stage of ‘notified SEZs’ have been the highest (90 per cent) in pharma sector. With regards to the overall functioning of SEZs, procedures related to obtain permission for acquiring/exporting materials/services, lack of transparency in certain procedures, getting sanction of claims and time taken for approval, have been the major hurdles to develop SEZs,” said Chintan Patel, Partner, Deal Advisory, KPMG-India.

According to industry experts, introduction of ‘Make in India’ policy and the functional pharma SEZs in India like the Jawaharlal Nehru Pharma City (JNPC) in Visakhapatnam, Andhra

Pradesh, developed as a joint venture between the Ramky Group and the government of Andhra Pradesh, PHARMEZ, Gujarat developed by Zydus Infrastructure and PhaEZ Park in Gujarat developed by Cadila Pharma, have kept the industry’s morale high.

A promising start …

As per the Union Commerce Ministry’s data on SEZ in India, out of the total 205 exporting SEZs in India, the pharma sector's contribution is only six per cent. According to Invest India, national investment promotion agency, Ranbaxy, Wockhardt, Dr Reddy's Laboratories, Lupin, Jubilant Life Sciences, Biocon, Divi's Lab, Zydus Cadila and Nicholas

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cover ) Revamping the single window clearance system, building an effective tax administration and reconsideration of MAT and DDT can bring stability and boost the development of pharmaceutical SEZs in India LV Chandrasekhar

Scrapping the MAT and DDT would revive investors’ interest in SEZ. This corrective measure will bring back SEZs to the forefront of economic and industrial development

If MAT, which is calculated on the book profits at a rate of around 21 percent is applied, then the advantage provided for the income tax exemption vanishes Sanjit Singh Lamba

PC Nambiar

Dr Lal Krishna

Managing Director, Eisai Pharmaceutical India

Chairman of the Export Promotion Council for EOUs and SEZs (EPCES)

CEO, Ramky Pharma City (India), Visakhapatnam

Owing to the tax benefits and SEZ developments, pharma industry contributes to the premier share of exports compared to other sectors.

Chintan Patel Partner, Deal Advisory, KPMG-India

Willingness on the part of the government, both the state and the central to add the value to the scheme will help the sector to come into the proper growth trajectory

Lead Finance, Eisai Pharmaceuticals India

Piramal are some key pharma players with manufacturing facilities in various SEZs. Informing that SEZs have been instrumental to attract multiple pharma and biotech companies Anil Khanna, Independent Strategic Consultant and Investment Banker, said, “SEZ has helped Indian pharma companies in their export business, which in current terms nearly equals to the domestic formulation business, which is nearly ` 100,000 crore.”

“Yes, the concept of SEZ is successful in India and now with time, apart from IT & ITES, the concept is also transcending in other domains especially in pharma. The government has been instrumental in promoting the development of SEZs in the pharma sector. A majority of the pharma sector SEZs have been ‘notified’ after being formally approved by the Centre. Currently, there are 16 SEZs under formal approvals and in notified SEZs, two are in in-principle approval category and 12 are in exporting SEZs,” said Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals India.

Eisai was the first Japanese

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company to have a 100 per cent subsidiary in the Indian pharma market, and chose to set up its manufacturing facility in the RamkyPharma City (SEZ), in Visakhapatnam, which was named Jawaharlal Nehru Pharma City in 2005.

Several factors have worked in favour of Indian pharma industry. According to McKinsey report on Pharma 2020, India is the third-largest exporter of pharma products in terms of volume and is slated to grow to $55 billion by 2020.

“Pharma is a growing sector and our strength is appreciated by the international community.

Globally, more and more companies are ready to take the Indian success story over the Chinese growth story. We have the expertise and strength to successfully engage agencies to cater to the global market. Willingness on the part of the government, both the state and the central will add value to the scheme. It will also help the sector to come into the proper growth trajectory. It will eventually create more job opportunities and foreign exchange revenues for the country,” said PC Nambiar,

Chairman, Export Promotion Council for EOUs and SEZs (EPCES).

Currently, the pharma and chemical segment in India contributes a major share of exports from SEZs , even though the number of operational pharma SEZs are low in comparison to IT/ITES industry. According to data from the India Brand Equity Foundation (IBEF), the Indian pharma sector accounts for about 2.4 per cent of the global pharma industry in value terms and 10 per cent in volume terms.

In FY 2015, the Indian pharma industry exported products worth $15 billion and exports are expected to reach $40 billion by 2020, opening up a plethora of opportunities. Availability of skilled manpower is expected to be a key growth driver for pharma industry in India, since an increasing number of pharma majors are looking to set up their establishments in the country.

For example, JNPC is buzzing with activity as 27 units have begun production in joint venture with drug majors from Germany and Japan.

“JNPC is a global destiny for manufacturers of bulk drugs,

active pharmaceutical ingredients and intermediates. In the current financial year, the total revenue of JNPC is ` 15,000 crores and in 2010, we had incurred revenue of ` 2000 crore.

Hence, we are growing steadily,” said Dr Lal Krishna, CEO, Ramky Pharma City (India) , Vishakhapatnam.

According to the JNPC website, 104 registered companies are within its premises, Besides Eisai Pharmaceuticals India, these include PharmaZell (I) (a company belonging to a German pharma group), SNF (I) (a company with French collaboration), Aptuit Laurus Labs with US collaboration. Leading Indian pharma names include Smilax Laboratories, Glochem, Orchid, Emmennar Biotech etc. JNPC reportedly employs to the tune of 13,000 plus and has the capcity to accommodate another 16,000, bringing home the fact that such zones spell immense employment opportunities for their sponsor state governments.

… but then things go wrong Although SEZs have a central role to play in the country’s economic growth, the imposition of

MAT and DDT, which has implications on cash-flow as well as RoI of companies, has been a major setback for all companies within SEZs, and the same is true for pharma.

Initially, exemption from DDT and MAT were two of the many incentives that attracted companies to SEZs. In 2011, both these exemptions were withdrawn. Companies and developers were levied 20 per cent MAT at book profits, and 21 per cent DDT on dividend to shareholders. It had become a a bone of contention between the government and industry players.

“The government should immediately scrap the MAT and DDT to revive investors’ interest in SEZ. This corrective measure will bring back SEZs to the forefront of economic and industrial development. A stable policy environment is need of the hour to restore confidence of domestic manufacturing and it would promote competitiveness as SEZs will boost manufacturing exports from India,” Krishna added.

It is to be understood that SEZ units contribute to the foreign exchange earnings of the

( urge the government to continue with the scheme in the original form and not let revenue consideration come in the way of SEZ

development. It is also the call of the government to exempt the domestic taxes on goods meant for export. Hence, the cries of

THE MAIN FOCUS

revenue foregone is a false alarm and the decision based on such revenue foregone figures is not a good idea to pursue.” He is of the

opinion that the government pursues such efforts made by the Finance Ministry from time to time, and this is a spoiler,

SEZ has helped Indian pharma companies in their export business, which in current terms nearly equals to the domestic formulation business, which is nearly ` 100,000 crore Anil Khanna Independent strategic consultant and investment banker

country on one hand and also encourages the business of many ancillary units. Attracting foreign investment to set up shop in India and then to penalise with DDT and MAT is an act that creates unrest, disbelief and discourages foreign investors to invest any further in India, according to experts.

“The concept of an SEZ is to provide full or partial exemption from income tax for 15 years. But if MAT, which is calculated on book profit at a rate of around 21 per cent is applied, then the advantage provided for income tax exemption vanishes. As for the first five years, the effective MAT rate of 21 per cent and for next five years at six per cent is carried forward, SEZ units could not set-off the credit because of tax exemption period.

This directly defeats the purpose of income tax exemption.

MAT also affects the cash flow of SEZ units and generates a feeling of disbelief on government promises,” Lamba said.

Informing that the introduction of MAT and DDT has tampered with the expected speed with which SEZ sought to have taken off, Nambiar said, “EPCES has made all efforts to

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EXPRESS PHARMA

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August 16-31, 2016

cover ) causing problems to this sector which has been trying to be sustainable since 2006 “The introduction of MAT and DDT was a retrograde step and this kind of an attempt to take away the promised benefits forced the investor community to rethink its association and go-slow on the SEZ operation,” Nambiar added.

According to experts, MAT and DDT should be either withdrawn or reduced to its original rate of 7.5 per cent. “If MAT is reduced to 7.5 per cent it will be a relief for investors and will provide better business facilitation packages. Hope the government will harmonise regulations across with a competitive tax regime. It is need of the hour,” Lal informed.

There could be signs that some changes might be in the offing. In May this year, responding to supplementaries during the Question Hour in Lok Sabha, Union Commerce Minister, Nirmala Sitharaman, reassured the industry that the review of the SEZ policy should not worry them and said, “The government, on the basis of inputs and suggestions received from stakeholders on the policy and operational framework of SEZ scheme periodically reviews the policy and the operational framework of SEZs and takes necessary measures so as to facilitate speedy and effective implementation of SEZ policy.”

Can ‘Make in India’ revive SEZs? While the tax and land acquisition issues still haunt SEZ promoters and developers, the Central Government is trying to link the SEZ concept with Prime Minister Modi’s ‘Make in India’ campaign, which primarily aims to attract foreign capital into manufacturing. Investors and industry players feel that the SEZ policy continues to be relevant from a ‘Make in India’ perspective but several policy initiatives are necessary to get those going.

The thought is logical, as globally the concept of SEZs has contributed greatly to manufacturing activities and also to exports. If SEZs are encouraged with true spirit in India, it can be the major contributor to 'The

20 EXPRESS PHARMA August 16-31, 2016

LIST OF APPROVED & IN-PRINCIPLE APPROVED PHARMA, BIOTECH SEZ DEVELOPER

LOCATION

STATE

TYPE OF SEZ

APPROVED Divi's Laboratories

Chippada

Andhra Pradesh

Pharmaceuticals

Ramky Pharma City (India)

Village Lemarthi,Visakhapatnam

Andhra Pradesh

Pharmaceuticals

Hetero Infrastructure SEZ

N Narsapuram

Andhra Pradesh

Bulk Drugs

Andhra Pradesh Industrial Infrastructure Corp

Rajapur & Pollepally

Andhra Pradesh

Pharmaceutical (formulations)

Meditab Specialities

Bhut-Khamb, Kerim,Tal Ponda

Goa

Pharmaceuticals

Zydus Finance

Ahmedabad

Gujarat

Pharmaceuticals

CPL Infrastructure

Dhandhuka,Ahmedabad

Gujarat

Pharmaceuticals

Karnataka Industrial Areas Development Board

Hassan District

Karnataka

Pharmaceuticals

Serum Institute of India

Pune

Maharashtra

Pharma & Biotech

MIDC

Krushnoor, dist. Nanded

Maharashtra

Pharma & Biotech

Wockhard Infrastructure Development

Shendre,Aurangabad Distt.

Maharashtra

Pharmaceutical

Maharashtra Industrial

Lote, Parshuram, District Ratnagiri

Maharashtra

Pharmaceutical

Ranbaxy Laboratories

Mohali

Punjab

Pharmaceuticals

IN-PRINCIPLE APPROVED Dr Reddy's Laboratories

Medak district

Andhra Pradesh

Pharmaceutical

Dr Reddy's Laboratories

Srikakulam district

Andhra Pradesh

Pharmaceuticals

Mis Jubliant Organosys

Vilayat

Gujarat

Pharmaceutical

Dishman Infrastructure

Village Kerala, near Ahmedabad

Gujarat

Pharmaceutical

BioPune HealthCare

Hosur, Krishnagiri District

TN

Pharmaceutical

Source : Ministry of Commerce and Industry, Government of India

LIST OF DRUGS AND PHARMACEUTICAL CLUSTERS Product

Location

State

Bulk drugs

Hyderabad

Andhra Pradesh

Pharmaceuticals

Margao

Goa

Pharmaceuticals

Ahmedabad

Gujarat

Bulk drugs

Ankleshwar

Gujarat

Bulk drugs

Vadodara

Gujarat

Bulk drugs

Indore

Madhya Pradesh

Bulk drugs

Mumbai

Maharashtra

Bulk drugs

Aurangabad

Maharashtra

Bulk drugs

Pune

Maharashtra

Bulk drugs

Tarapur

Maharashtra

Pharmaceuticals

Cuttack

Odisha Source : SIDO/D&B Research

Make in India' vision but at the same time, there should be discipline in the government machinery with consistency in their actions. More importantly, SEZ units should be understood as a tool to heal and help the balance of payment situation by generating foreign exchange for the country.

“Make in India is definitely going to help the SEZs in pharma sector. India being the largest supplier of cost-effective generic medicines to the developed world, is on the path to becoming a leader in pharma exports to the world. Many foreign companies would like to do business in India or with India, as the sector gives widest range of cost benefits. Be it in terms of labour cost, R&D cost or scientific manpower, India is full of

opportunities for the pharma industry,” said LV Chandrasekhar, Lead Finance, Eisai Pharmaceuticals India. Giving some suggestions of what needs to be put in place to realise this opportunity, Chandrasekhar opines, “The overall consistency across the system while providing approvals, speedy procedures and crafting transparent policies could provide sustainability to SEZ developments. Revamping the single window clearance system, building an effective tax administration and reconsideration of MAT and DDT can bring stability and boost the development of pharma SEZs in India.”

A casualty of (interministerial) war?

According to EPCES, sustainable development in the

( The pharma industry has been contributing a premier share of exports compared to other sectors

sector. The balance of payment crisis is also not of a very serious concern now and hence required impetus is not

being provided.”

The SEZ policy definitely has an eminent role to play in the country’s economic growth,

THE MAIN FOCUS

but all that is required are conducive policies and a comprehensive overhaul. Only then can it achieve its true potential

and become a pivotal piece of the government's ‘Make in India’ programme. prathiba.raju@expressindia.com

Government of India's Make in India initiative will breathe new life into SEZs and pharma SEZs ?

India is the third-largest exporter of pharma products in terms of volume and is slated to grow to $55 billion by 2020

pharma sector can happen only if intervention from the government at functional level is reduced. As Nambiar puts it, “Single window clearance is necessary. Having sought approval from the government as a SEZ unit, the company has disclosed all the facts to the Union Commerce Ministry.

The ministry being the nodal agency for SEZ function should be the only single window for resolving all problems related to SEZ operations.

This feature is present in the SEZ in the Act but at the ground level, the implementation is rather poor. If the single window mechanism for all the statutory permissions is made operational as originally conceived, the pharma sector will see a boom and create enough export potential and generate employment for a lot of people in the country. A lot of foreign investors are waiting in the wings to see the kind of development that is being made by the SEZs to decide their investment strategy.”

Coming to the nub of the issue, Nambiar points out, “The progress has been rather slow because the Finance Ministry is over shadowing each and every step of the Commerce Ministry, to promote the SEZ

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EXPRESS PHARMA

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August 16-31, 2016

cover )

Sikkim THE POTENTIAL PHARMA HUB

Thanks to the North-East Industrial and Investment Promotion Policy (NEIIPP) 2007, Sikkim has been able to offer a host of tax benefits to the industry. Thus it is no wonder that the state has already attracted an investment of over $400 million from 22 major pharma companies in the last three years. At this pace, the state could emerge as a major pharma hub in the North Eastern region by 2018

22 EXPRESS PHARMA August 16-31, 2016

(

400

S

ikkim, a pristine hilly state renowned tourist destination, could turn also out to be the next pharma hub in the country. Situated amidst the verdant Eastern Himalayas, the state has already attracted an investment of over $400 million (`2000 crores) from 22 major pharma companies in the last three years.

Marquee companies like Cipla, Sun Pharma, Zydus Cadila, Alembic, IPCA, Alkem Lab, Intas Pharma, Torrent Pharmaceuticals and Unichem have reportedly set up their units in the state.

Sikkim - the new pharma buzz Many pharma companies and their ancillary units have migrated from Baddi in Himachal Pradesh and Uttarakhand to Sikkim, as the excise duty exemption given to these states will soon expire.

In order to avail tax benefits for the next ten years, several pharma companies have opted to migrate to Sikkim.

Besides tax incentives, low manufacturing and labour costs and a pollution-free environment have also proved to be the key attractions for these pharma companies. “Twenty years ago, Baddi was just a dusty town. There was no industry and a dearth of opportunities for locals.

The tax holiday announced in 2003 transformed Baddi into Asia's largest pharma hub which eventually became one of the biggest industrial centres in North India. But with the tax holiday likely to end, the scenario is changing.

Now, pharma companies have made a beeline to Sikkim to avail the excise benefits,� informs J Jayaseelan,

EXPRESS PHARMA

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August 16-31, 2016

$

MILLION

Sikkim has already attracted an investment of over

from 22 major pharma companies in the last three years

THE MAIN FOCUS

cover ) Chairman of the Tamil Nadu chapter of Indian Drugs Manufacturers Association (IDMA).

Sikkim, which offers 100 per cent excise and income tax benefits in addition to freight subsidy, provides continuous support to set up new plants with other facilities. By 2018, the state will become a full-fledged pharma hub in the North Eastern region, predict industry experts.

A senior official from Commerce and Industries Department, Government of Sikkim, while speaking to Express Pharma, on condition of anonymity said, “Today, Sikkim is home to as many as 22 pharma companies, out of which 16 are big firms, one is medium and five are small scale firms. These include the who’s who of the Indian pharma sector such as Cipla, Sun, Zydus Cadila, Alembic, IPCA, Alkem, Intas, Torrent, Unichem and Micro Labs.”

According to the official, North-East Industrial and Investment Promotion Policy (NEIIPP) 2007 has played an active role to attract pharma investments in the state.

“Many pharma companies have set up shop because of the big tax advantages as earning is at a faster pace due to tax savings. Apart from pharma companies, ancillary units like packaging, access to raw materials, components, machinery, have also set up their base. We are now working to make the state more conducive for pharma units, so that it can become a major pharma destination in the next two years,” the official stated.

Giving an industry view point, Suresh Pareek, Managing Director, Ideal Cures, a company manufacturing and exporting pharma excipients and ready-to-use coating systems, said, “Logistically, Guwahati is the most ideal location for pharma companies, but due to insurgency issues, it did not develop.

Though Sikkim has issues of air and rail connectivity, the state offers a conducive work

24 EXPRESS PHARMA August 16-31, 2016

The tax holiday announced in 2003 transformed Baddi into Asia's largest pharma hub which eventually became one of the biggest industrial centres in north India. But with the tax holiday likely to end, the scenario is changing. Now, pharma companies have made a beeline to Sikkim to avail of the excise benefits

Logistically, Guwahati is the most ideal location for pharma companies, but due to insurgency issues, but it did not develop.

Though Sikkim has issues of air and rail connectivity, it has a conducive work environment

J Jayaseelan

Suresh Pareek

Chairman,Tamil Nadu Chapter, IDMA

Managing Director, Ideal Cures

Companies like Cipla, Sun Pharma, Zydus Cadila,Alembic, IPCA,Alkem Lab, Intas Pharma,Torrent Pharmaceuticals and Unichem have reportedly already set up their units in the state

environment. Currently, 30 pharma plants have their presence in the state. A few have started their facilities, while others are yet to be operational.” Ideal Cures is also currently setting up a large facility, which is likely to be operational by January 2017.

Role of NEIIPP The steady increase of pharma investments in Sikkim is easy to understand if one considers the policies at play. In 2007, the Government of India had approved a package of fiscal incentives and other concessions for the North East Region, namely the North East Industrial and Investment Promotion Policy (NEIIPP), which was a boon for pharma companies and ancillary units in the region.

The Centre, however, suspended NEIIPP in December 2014 and it will expire by March 2017. Suspension of NEIIPP will be a major hurdle for the North Eastern states, particularly for the pharma industry, as many big companies have invested and are in the process of further investing in the state. However, the

Sikkim, which offers 100 per cent excise and income tax benefits in addition to the freight subsidy, provides continuous support to set up news plants with other facilities By 2018, the state will become a full-fledged pharma hub in the North Eastern region

Union Finance Ministry, in its notification, said that existing units undertaking ‘substantial expansion’ between December 1, 2014 to March 31, 2017 (the date when NEIIPP expires) will continue enjoying excise duty exemption for a period of ten years, it also mentioned that new units registered during the same period would be also eligible for the excise exemption.

Under NEIIPP, which came into force from April 1, 2007, with a validity of ten years, industrial units in the North East region are eligible for 30 per cent capital investment subsidy, income tax subsidy, excise duty exemption (varying from goods to goods), and reimbursement of insurance premium paid on capital assets, among others. Industrial units can enjoy these benefits for a period of ten years.

A notification from the Union Finance Ministry states, “Doubts have been raised regarding the availability or otherwise of central excise duty exemption under notification No.20/2007 dated 25.04.2007 to new units or

Today, Sikkim is home to as many as 22 pharma companies, out of which 16 are big firms, one is medium and five are small scale firms.These include the who’s who of Indian pharma sector such as Cipla, Sun,Zydus Cadila,Alembic, IPCA,Alkem, Intas,Torrent, Unichem and Micro Labs.”

( units undertaking substantial expansion after 1.12.2014 in the North Eastern region including Sikkim pursuant to the suspension of fresh registrations under NEIIPP. The matter has been examined by the Ministry of Finance in consultation with Department of Industrial Policy and Promotion (DIPP). It clarified that new units or units undertaking substantial expansion shall continue to be eligible

According to industry experts, by 2018, the state will become a full-fledged pharma hub in the North Eastern region for excise duty exemption.”

“Although the Centre’s notification has brought clarity among the industries, NEIIPP should be restored for ease of trade in the North Eastern region,” informs RS Joshi, Chairman, Federation of Industry and Commerce of North Eastern Region (FINER), the premier trade and industry body of the North East.

“Any industrial unit, which will start its operation on or within March 2017, will get tax exemptions. If big pharma companies can start production before March 2017, they will be eligible for tax benefits for the next ten years i.e. till March 2027. But, since there is less time available for new units to come up, so we have asked for extension of time. The government is yet to give any clear signal,” says Joshi.

Joshi further says, “Suspension of NEIIPP is a matter

EXPRESS PHARMA

25

August 16-31, 2016

of great concern as the policy was helpful to attract investment for 'Make in North-East' and its continuation is a must to make 'Make in India' initiative successful.

Suspension of NEIIPP will badly affect all North Eastern states.”

“Sikkim has benefitted by the NEIIPP policy 2007. With a large industry base of pharma and ancillary units, the state has been able to provide more employment and create new jobs.

Ultimately, the state government is reaping the

THE MAIN FOCUS

benefits. If NEIIPP is suspended, industrial development will come to a halt,” cautions Pareek.

Thus, many experts are of the opinion that the government should rethink its decision to discontinue with NEIIPP. They also recommend

implementing more effective financial mechanisms, introducing industry-friendly polices and an increased focus on infrastructure development to sustain and propel Sikkim’s growth as a pharma hub. prathiba.raju@expressindia.com

MANAGEMENT REPORTS

VTE therapeutics market set to hit $3.7 billion by 2025: GlobalData It will represent a CAGR of 2.89 per cent THE THERAPEUTICS market for venous thromboembolism (VTE), a condition which comprises deep vein thrombosis and pulmonary embolism, is set to rise from $2.8 billion in 2015 to $3.7 billion by 2025, representing a Compound Annual Growth Rate (CAGR) of 2.89 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this steady growth, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven primarily by the rise in sales surrounding the VTE primary prophylaxis space, which is projected to increase from $2.4 billion in 2015 to $3.5 billion by 2025, at a CAGR of 4.01 per cent.

Michela McMullan, Analyst, GlobalData, covering cardiovascular and metabolic disorders, explains, “Novel oral anticoagulants (NOACs), which are used to prevent and treat VTE, will primarily drive the market, and represent important advances over warfarin, a cheap and established anticoagulant. This is because NOACs do not require routine blood monitoring or dose adjustments, have fewer drug-drug interactions, do not produce major dietary effects, and in terms of efficacy and safety, have been proven to be non-inferior, if not superior, compared with warfarin.”

GlobalData believes that as physician familiarity with these drugs increases, and experience is gained in selecting the appropriate NOAC dependent on a

26 EXPRESS PHARMA August 16-31, 2016

The therapeutics market for VTE

$2.8 $3.7 billion in 2015

billion in 2025

The therapeutics market for venous thromboembolism (VTE), a condition which comprises deep vein thrombosis and pulmonary embolism, is set to rise

Steady growth in the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven primarily by the rise in sales surrounding the VTE primary prophylaxis space patient’s risk profile, further NOAC uptake will occur across all markets. Indeed, Pradaxa, Xarelto, and Eliquis, which are all currently available, will see improved uptake over the forecast period. In addition, the recent launch of a fourth NOAC, Savaysa, in the US and Japan will give physicians further treatment options when deciding on which anticoagulant is most suitable for their patients, and is also expected to impact overall NOAC uptake.

McMullan continues, “Despite the benefits that NOACs will bring to the VTE market, the treatment space still requires a transformational ther-

apy to push its growth rate up beyond current levels. In order to develop a drug that offers transformational changes in terms of safety instead of incremental benefits, focus would need to be turned towards better renal function and optimal care for cancer patients. A drug with a superior renal clearance profile could command premium pricing in this market and would be accepted more easily.

The ideal drug should be oral, have a once-a-day dosing, should not depend on monitoring, and should be usable for patients in all stages of renal impairment.”

EP News Bureau-Mumbai

Newer therapies will steer Type II diabetes market in South-East Asia The market will see a rise from $1.7 billion in 2015 to $2.7 billion by 2022, says GBI Research THE SOUTH-EAST Asian Type II diabetes mellitus (T2DM) market, which includes South Korea, Singapore, Taiwan, Malaysia, the Philippines, Thailand, Vietnam and Indonesia, will rise from $1.7 billion in 2015 to $2.7 billion by 2022, at a compound annual growth rate of 7.1 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that as well as the rapidly expanding prevalence population in South-East Asia, market growth will be driven by the increased uptake of recently approved and emerging branded T2DM therapeutics, in favour of lower-cost generic products.

Aswini Nath, Analyst, GBI Research, explains, “Unmet needs relating to patient convenience and ease of use will be addressed significantly over the forecast period.

Higher levels of innovation are apparent in the early-stage pipeline, which may lead to considerable improvements beyond the existing range of products, in terms of safety and efficacy in the long term.”

Nath said, “In terms of recently approved therapeutics, GLP-1 receptor agonists, DPP4 inhibitors, and SGLT-2 inhibitors have already achieved strong market uptake and are all expected to increase their market shares over the forecast period. In comparison with many previously marketed therapies, these new products provide improved

weight control and lowered hypoglycemia risk.”

In terms of late-stage pipeline products with the potential to change the treatment paradigm, six candidates stand out as offering superior safety, efficacy, and patient compliance. These are Novo Nordisk’s NN-9535 (semaglutide subcutaneous formulation) and OG-217SC (semaglutide oral formulation) and Eli Lilly’s Trulicity (dulaglutide), which are GLP-1 receptor agonists; Merck’s ertugliflozin and Theracos's bexagliflozin, which are SGLT2 inhibitors; and Merck’s omarigliptin, which is a DPP4 inhibitor.

Of these products, GBI Research believes that OG217SC, being a first-to-market oral formulation in the GLP-1 agonist class of drug, has the most potential to change the treatment paradigm due to its improved administration route compared to other drugs in the same class.

However, Nath adds, “Although increased uptake of branded drugs is expected, metformin, a low-cost generic drug, will maintain its pivotal role in the T2DM treatment algorithm in South-East Asia.

Due to its well-characterised safety and efficacy profiles, wide availability and low cost, metformin will continue to be prescribed as the first-line pharmacotherapy and also remain the favoured option for use in combination therapies.”

EP News Bureau-Mumbai

Atrial fibrillation market will peak in 2022 The market will however see a rapid decline to $4.9 billion by 2025, says GlobalData THE ATRIAL fibrillation market will expand from approximately $8 billion in 2015 to hit its peak of $11.8 billion in 2022, after which the impact of patent expiries will see the market value fall rapidly to $4.9 billion by 2025, according to research and consulting firm GlobalData.

The company’s latest report states that the market, which covers the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and Canada, will decline after 2022 due to the entry of the first generics of the new oral anticoagulants (NOACs), starting with Boehringer Ingelheim’s anticipated loss of the US, Japanese and Canadian patent protection for Pradaxa in 2018.

Jesus Cuaron, Senior Analyst, GlobaData covering cardiovascular and metabolic disorders, explains, “Since the launch of the first NOACs in 2010, this drug class has experienced substantial uptake, accounting for $6.8 billion, approximately 85 per cent of all atrial fibrillation sales revenue across the 8MM in 2015.

This uptake will continue to increase, and will be the main driver of growth in the atrial fibrillation space through 2022.”

Cuaron said, “This growth will be driven further by the launch of a fourth NOAC, Daiichi-Sankyo’s Savaysa, which was first approved in Japan for stoke prevention in patients with atrial fibrillation in 2014. The continued uptake of such NOACs, along with the approval and launch of the first NOAC reversal agents for use in the event of uncontrolled bleeding, will contribute to initial market growth.” However, GlobalData believes that a number of major barriers will hinder the growth of the atrial fibrillation space, including the generic erosion of multiple NOACs across the 8MM by 2023, and the large, costly, and comprehensive clinical trials required to support regulatory approval of novel anti-arrhythmic drugs.

EP News Bureau-Mumbai

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RESEARCH UPDATES

Experimental vaccine could provide rapid response to diseases The vaccines harness messenger RNA, a genetic material that can be programmed to fight any viral, bacterial or parasitic disease by provoking an amplified immune response in the body

A

type of experimental vaccine that can be made in just a week and has protected mice against influenza, Ebola and Zika viruses may offer promise for quick responses to disease outbreaks in people, according to Massachusetts Institute of Technology researchers. MIT scientists said their vaccines, still in early developmental stages, harness messenger RNA, a genetic material that can be programmed to fight any viral, bacterial or parasitic disease by provoking an amplified immune response in the body. The messenger RNA is put into a molecule that delivers it into cells to generate an immune response against a

particular pathogen.

The researchers said their approach allows for quickly creating vaccines customised to fight various pathogens, in contrast to the lengthy development needed

for traditional vaccines. An RNA vaccine differs from most current types that involve an inactivated form of a virus or other pathogen.

“When there is an extraordinary need and you need something that is safe, then we have the ability to make that happen,” said Omar Khan, an MIT chemical engineer who helped pioneer the technology.

“So things like Zika or the recent Ebola outbreak, we can rapidly respond to that within seven days,” Khan said. The current outbreak of the Zika virus, which is spreading rapidly in the Americas and has been found to cause a serious birth defect called microcephaly, illustrates the value of a vaccine that could be quickly pro-

grammed against a particular pathogen. Researchers around the world are racing to produce a Zika vaccine. But conventional vaccines, made from a purified but inactivated version of the virus, can take months or years to manufacture.

While the idea of using messenger RNA has been around for decades, a package to deliver it into cells has proven difficult to design. The researchers packaged the RNA vaccines into molecules whose shape and electrical charge they can manipulate, allowing them to enter cells in much the same way viruses do, according to Daniel Anderson, an MIT professor of applied biology and chemical engineering.

The scientists developed and tested vaccines against Ebola and H1N1 flu that proved 100 per cent effective in lab mice in a study published in July in the Proceedings of the National Academy of Sciences. Since that study, according to Kahn, the researchers have tested an RNA vaccine for Zika in mice and have had similarly successful results.

"The nanoparticle goes inside of the cell and then releases this RNA, and then the RNA makes copies of itself and it also makes proteins that are antigens (inducing an immune response). So these are the same types of proteins you might get for a vaccine," Anderson said.

Reuters

Biogen exercises option to develop muscle drug after trial success The drug, nusinersen, was being developed by Biogen in collaboration with Ionis Pharmaceuticals BIOGEN SAID it would exercise an option to develop and commercialise an experimental genetic muscle-disorder drug after an interim analysis of latestage data showed patients experienced statistically significant improvement. The drug, nusinersen, was being developed by Biogen in collaboration with Ionis Pharmaceuticals, to treat spinal muscular atrophy (SMA).

The genetic disease disrupts

28 EXPRESS PHARMA August 16-31, 2016

the part of the nervous system that controls voluntary muscle movement, eventually taking away an individual’s ability to walk, eat, or breathe. Currently, there exists no approved treatment for the condition, which is the leading genetic cause of death in infants. It affects about one in 10,000 babies, and some one in every 50 Americans is a genetic carrier, according to Illinois-based Cure SMA. In the interim analysis of the

late-stage trial in infants with a form of SMA, nusinersen met the main goal of improving motor symptoms. Based on this data, the trial will be stopped, and patients can receive the drug in a follow-on study, the companies said.

Biogen also said it had paid Ionis a $75 million license fee to take responsibility for the product's development, regulatory and commercialisation activities and costs going forward. Facing

slowing growth of its flagship drug Tecfidera, Biogen last year embarked on a sweeping restructuring programme to focus on core areas, such as neurology,

with high-risk, potentially highreward experimental treatments for Alzheimer’s among others.

Reuters

Flu vaccine may help keep diabetics out of hospital Vaccination was associated with a 30 per cent lower hospital admission rates for stroke PEOPLE WITH diabetes who get the flu vaccine may be less likely to wind up hospitalised for cardiovascular or respiratory problems, a recent study suggests. “The potential impact of influenza vaccine to reduce serious illness and death highlight the importance to renew efforts to ensure that people with diabetes receive the flu vaccine every year,” said lead study author Dr Eszter Vamos, a public health researcher at Imperial College London.

Vamos and colleagues examined seven years of data on almost 125,000 people in England with type II diabetes, which is associated with ageing and obesity and accounts for most cases of the disease. Vaccination was associated with a 30 per cent lower hospital admission rates for stroke, 22 per cent lower rates for heart failure, and 15 per cent lower rates for pneumonia or influenza, researchers report in CMAJ. To understand how flu vaccines may influence the odds of hospitalisation and death for diabetics, researchers examined data on patients’ age, weight, smoking status and gender and looked at whether patients had a diagnosis or prescription for conditions for a variety of other medical conditions. They looked at records both during the flu season and during summer months when influenza cases were less common. Patients who got the flu vaccine had 24 per cent lower death rates from all causes during the study period.

They also had lower rates of hospitalisation for heart attack, but the difference wasn’t big enough to rule out the possibility that it was due to chance. One limitation of the study is that researchers weren’t able to assess the possibility that some people had undiagnosed diabetes, the authors note. It’s also possible that people who get vaccinated are healthier in other ways than people who skip their annual flu vaccine, the authors also point out.

Reuters

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RESEARCH

TauRxAlzheimer’s drug fails in large study However, the drug did show a benefit in a small group of patients who were not taking other standard Alzheimer's drugs TAURX Pharmaceuticals' experimental Alzheimer's drug LMTX failed to improve cognitive and functional skills in patients with mild to moderate Alzheimer's disease, a large, late-stage study showed. But the drug did show a benefit in a small group of patients who were not taking other standard Alzheimer's drugs, according to the findings released at the Alzheimer's Association International Conference in Toronto.

Claude Wischik, Co-founder of Singapore-based TauRx and a professor of geriatric psychiatry at Aberdeen University, said the drug reduced the rate of decline in cognitive and functional skills by 85 per cent in that so-called 'monotherapy' group.

While the overall study involved 891 elderly subjects, only 15 per cent, or some 136 people, were not taking standard Alzheimer's drugs. "It's a small proportion that showed a benefit. That is why they weren't able to achieve significance," said Dr

Laurie Ryan, Chief of the Dementia of Aging Branch, National Institute on Aging.

"It's intriguing, but it doesn't tell us a lot yet at this point," Ryan said. Mayo Clinic Alzheimer's expert Dr Ronald Petersen said the study begs the question of why patients with mild or moderate Alzheimer's were not receiving standard therapies. The findings are the first from a large-scale trial of a drug that targets the Alzheimer's-related protein tau, which forms toxic tangles of nerve fibres associated with the fatal disease. Current treatments help improve Alzheimer's symptoms, but no drug has yet been shown to slow disease progression. After several years of failed drug trials targeting betaamyloid, the Alzheimer's protein that forms sticky plaques in the brain, several companies, including Eli Lilly, Biogen and AbbVie, have begun targeting tau, a protein linked with cell death.

Petersen said the TauRx

The nasal cavity is also a rich ecosystem of 50 or so different species of bacteria

findings do not mean that pursuing tau therapies is ill-advised. "The notion that tau is still a very viable target for treatment in Alzheimer's disease remains live and well."

TauRx is currently studying LMTX in an 800-patient trial of patients with mild Alzheimer's.

Results are expected to be presented later this year. More than 5 million Americans have Alzheimer's, according to the Alzheimer’s Association.

Reuters

Celgene drug fails to extend survival in lymphoma study The US biotechnology company said it would not seek an additional approval for Revlimid CELGENE CORP said that its flagship drug Revlimid failed to extend survival as a maintenance therapy for a type of blood cancer after patients had responded to prior treatment. As a result, the US biotechnology company said it would not seek an additional approval for Revlimid for that use. Revlimid, a multiple myeloma treatment

30 EXPRESS PHARMA August 16-31, 2016

with annual sales of about $6 billion, was being tested versus a placebo in patients whose diffuse large B-cell lymphoma had responded to initial treatment with Roche's Rituxan and chemotherapy.

Approval as a maintenance therapy, used to prevent recurrence and improve survival, can significantly add to sales as the

Scientists find potential new antibiotic,right under their noses

drugs are taken long term.

While the Revlimid study delayed progression of the disease, no survival benefit was seen, the company said. The trial was conducted along with the Lymphoma Study Association. Celgene said it will continue to study Revlimid in a variety of lymphomas.

Reuters

SCIENTISTS IN Germany have discovered a bacteria hiding out in peoples' noses that produces an antibiotic compound that can kill several dangerous pathogens, including the superbug MRSA. The early-stage finding, reported in the journal Nature, could one day lead to a whole new class of antibiotic medicines being developed to fight drug-resistant bacterial infections, the researchers said.

As well as being a focal point for many viral infections, the nasal cavity is also a rich ecosystem of 50 or so different species of bacteria, lead researcher Andreas Peschel of the University of Tuebingen told reporters. "(That's) the reason why we looked at this particular body site. (And) it led us to some very unexpected and exciting findings that may be very helpful in looking for new concepts for the development of antibiotics." Most antibiotics discovered and developed until now have been isolated from soil-living or other environmental bacteria, but the researchers said this discovery highlights the value of the human microbiome as a potential new source.

"The human body has a lot of different ecological niches," Peschel said. "Maybe this is just the right place to look for new human antibiotics. "Lugdunin is an example that we've been able to characterise. We're sure there will be others to dis-

cover." Naming their new discovery lugdunin, the researchers said it was the first known example of a new class of peptide antibiotics.

Lugdunin is produced by the nostril-dwelling bacterium Staphylococcus lugdunensis (S lugdunensis). In experiments with mice, Peschel's team showed it is able to effectively treat a skin infection caused by the bacteria Staphylococcus aureus (S aureus), which can cause serious and superbug infections.

They also found lugdunin was effective against a wide range of so-called Gram-positive bacteria, including strains of methicillin-resistant Staphylococcus aureus (MRSA). The researchers then analysed nasal swabs from 187 hospital patients and found that in those who had the S lugdunensis bacteria in their noses, only 5.9 per cent also harboured the potential infectious S aureus bacteria. In those with no S. lugdunensis, however, 34.7 per cent were found to have S aureus in their noses. This suggests that in the human nose, S lugdunensis helps to keep S aureus at bay, the researchers said.

Peschel stressed that the research is at a very early stage and the team would need many years of work, ideally with a pharmaceutical company, before a potential new antibiotic medicine could be developed and tested in clinical trials.

Reuters

RESEARCH

Bristol-Myers’Opdivo fails lung cancer trial Opdivo won approval in March 2015 for treatment of patients with advanced non-small cell lung cancer who had previously failed to benefit from chemotherapy BRISTOL-MYERS Squibb Co said its blockbuster Opdivo immunotherapy failed to slow progression of symptoms in previously untreated patients with advanced lung cancer, a major setback expected to benefit Merck & Co's rival medicine.

Opdivo had been considered the clear leader in a costly new class of medicines called checkpoint inhibitors that work by taking the brakes off the immune system. Its second-quarter sales of $840 million were more than double those of Merck's Keytruda.

Opdivo won approval in March 2015 for treatment of patients with advanced non-small cell lung cancer who had previously failed to benefit from chemotherapy. Six months later, Keytruda received approval for a similar patient population.

Meanwhile, both companies raced to complete large trials to see if their drugs, which each cost about $150,000 a year, would also benefit patients who had never previously been treated for the most common form of lung cancer. The trials compared the drugs against chemotherapy.

Patients in the Opdivo trial had tumours with low levels of PD-L1, a protein whose presence may help identify those most likely to benefit from checkpoint inhibitors. Those in the successful Merck trial, by contrast, were only enrolled if they were shown to have high levels of PD-L1 and represented a smaller percentage of the lung cancer population.

Data in June from a large clinical study showed Keytruda was effective in newly treated patients, not only in delaying progression of lung cancer symptoms but also in prolonging survival. The trial was stopped so that all patients could receive Keytruda.

The data spurred hopes that US regulators would soon expand approved use of the Merck drug. Complete data for the study has not yet been released.

Reuters

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August 16-31, 2016

RESEARCH

Malaria drug may help in cancer fight, early research finds Malaria drug atovaquone boosted oxygen levels in tumour cells in mice, making radiotherapy more effective against a range of cancer types AN OFF-PATENT malaria drug could help to destroy cancer cells by making them more susceptible to radiotherapy, according to early work that has prompted British scientists to start a clinical trial. Researchers reported that atovaquone boosted oxygen levels in tumour cells in mice, making radiotherapy more effective against a range of cancer types, including lung, bowel, brain and head and neck cancer. Cancer cells with low oxygen levels are more difficult to treat with radiotherapy and are more likely to spread to other parts of the body.

“We have now started a clinical trial to see if we can show the same results in cancer patients,” said lead researcher Gillies McKenna of the Cancer Research UK Radiation Research Centre in Oxford. "We hope that this existing low-cost drug will mean that resistant tumours can be re-sensitised to radiotherapy.

And we’re using a drug that we already know is safe." His team's findings were published in the journal Nature Communications. The idea of re-purposing existing drugs to fight cancer is gaining traction as scientists realise that older

medicines can sometimes complement other therapies.

The fact that such drugs are already off patent means they are cheap, but the lack of patent protection is also a potential problem because drug companies investing in latestage research have less certainty of a commercial payback. Atovaquone is used to both treat and prevent malaria.

It is usually prescribed to travelers as Malarone, a combination of atovaquone and proguanil developed by GlaxoSmithKline.

Reuters

Scientists hunt ‘anti-evolution’drugs in new cancer fight Over the next five years, the ICR aims to discover at least one new drug targeting a novel evolutionary mechanism and a new immunotherapy SCIENTISTS ARE opening a new front in the war on cancer with plans to develop 'anti-evolution' drugs to stop tumour cells from developing resistance to treatment. Britain's Institute of Cancer Research (ICR), one of the world's top cancer centres, said its initiative was the first to have at its heart the target of overcoming cancer evolution and drug resistance. In the same way that bacteria evolve resistance to antibiotics, cancer cells also change to evade the medicines used to fight them, leading to "survival of the nastiest."

As a result, most cancer drugs eventually stop working, causing patients to relapse.

There are signs, however, that drugs can be developed to tackle this problem, while advances in immunotherapy may also make it possible to direct

32

EXPRESS PHARMA

August 16-31, 2016

patients' immune systems to adapt in response to cancer changes.

Over the next five years, the ICR aims to discover at least one new drug targeting a novel evolutionary mechanism and a new immunotherapy. While doctors have known about cancer drug resistance for decades, it is only now, with advances in genetics and the development of ultra-fast DNA sequencing, that scientists are unravelling the factors driving the process. "We now have an incredibly precise understanding of the genetic basis for resistance," said Paul Workman, Chief Executive, ICR. "Over the next five years, we will focus all our efforts on overcoming this problem we need researchers around the world to embrace the challenge."

Already an experimental

medicine inhibiting the protein Hsp90, which cancer cells use to protect themselves from stress, has shown encouraging results in clinical trials. ICR

scientists are also working on an even more important controller of the stress response known as HSF1. Workman said experiments on HSF1 were still

at an early stage but scientists were close to selecting a drug candidate. The end result is likely be the development of a number of combination treatments to stop cancer evolving, similar to the drug cocktails used to control HIV or tuberculosis.

In addition to understanding biology, a large part of the research effort will be driven by 'big data', through the use of mathematical models to predict the path of cancer evolution from tumour samples.

Tapping into the terabytes of data thrown up by analysing the genetic profiles of tumours is an increasing focus of cancer research worldwide. It is also a central plank of US Vice President Joe Biden’s ‘moonshot’ initiative aimed at finding cures for cancer.

Reuters

RESEARCH

Novartis asthma pill shows promise in small trial Fevipiprant by Novartis reduced a biological marker of asthma nearly five-fold in the 12-week trial involving 61 patients THE FIRST new asthma pill in decades has produced promising results in a small clinical trial, potentially paving the way for another treatment option for patients by the end of the decade. Fevipiprant, which is being developed by Novartis, reduced a biological marker of asthma nearly five-fold in the 12week trial involving 61 patients, researchers said. No serious adverse events were reported.

Larger and longer studies are now needed to prove that the twice-daily pill can also reduce severe asthma attacks, known as exacerbations.

The Novartis pill works in a very precise way to block the action of inflammatory cells called eosinophils Novartis believes the medicine could be filed for regulatory approval in around 2019.

Pills for asthma used to be standard treatment 40 or 50 years ago, but those older products were often associated with worrying side effects. They have since been replaced by inhalers that deliver small amounts of drugs directly into the lungs. The Novartis pill works in a very precise way to block the action of inflammatory cells called eosinophils.

The latest research, published in the journal Lancet Respiratory Medicine, comes at a time of considerable innovation in asthma care, with the recent launch of new injectable drugs for severe asthma that also target eosinophils. At the same time, many drugmakers are developing improved asthma inhalers, including ‘smart’ devices with sensors that monitor use.

Reuters

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August 16-31, 2016

PHARMA TECHNOLOGY REVIEW

How secure is your data?

The pharma industry needs to implement stronger measures to prevent data thefts and plug loopholes in their data security systems

BY SACHIN JAGDALE

34 EXPRESS PHARMA August 16-31, 2016

A

t every level of a product life cycle, from idea to product, pharmaceutical companies have to worry about protecting their sensitive data. Especially during the early stages of product development as they provide the competitive edge to the company. However, there is no dearth of avenues for data to get leaked, for instance, it is not uncommon to hear about cases of marketing plans being stolen. Patients’ information getting leaked and inhouse employee passing on the confidential data to rivals etc. have also been reported globally, time and again.

Protecting pivotal data Though every piece of data is important for the industry, loss of a certain type of information can badly affect the business of a company.

Dr Parijat Kanetkar, Consultant, Chemicalli explains, “Confidential technical data for R&D projects, government data related to the public (personal information and social security numbers), technical data related to pharma, biotech products and chemicals which are the IPR of the manufacturing companies, trading information, internal email discussions for a potential business deal (leaked to the press), confidential health related information of patients are major targets for the miscreants.”

The pharma industry perhaps ranks highest among the most data sensitive industries in the world.

Though data theft is not a rare phenomenon for the industry, involvement of its own employees in the data leakage is what worries the industry the most. So much so that it is sometimes easier for pharma companies to keep check on external efforts of stealing data, identifying in-house culprit requires real luck.

As Joseph Kiran Kumar, Head - Information Technology, Eisai Pharmaceuticals India points out, “Around 70 per cent of the data leakages can be attributed to be the handiwork of existing employees. With around 80 per cent companies not having a policy that protects the data from the leaving employee makes the situation even more vulnerable.”

Pharma companies invest billions of dollars to develop one new mole-

cule. So, data leak of any sort during the molecule development phase could even cast shadows on the future of the company.

“Data pertaining to critical business processes, personal data are usually the targets. For the researchbased organisations data that has greater Intellectual Property (IP) value is the prime target. There have been many instances where such data was stolen. Costs for IP theft within the UK pharma, biotech and healthcare sectors were reported in the OCISA report to cost £1.8 billion annually, primarily due to the large volume of data generated by this industry,” adds Kiran Kumar.

Many companies now allow their staff to work from home and often provide the necessary gadgets to their employees to help them operate from anywhere they want. Many assignments also require modern-day employees to travel extensively, within the country and overseas. These circumstances have caused employees to extensively rely on online methods of communication, data storage etc.

This, in turn, has also increased the chances of data being stolen. Thus, it has become imperative for pharma companies to take appropriate measures to secure their data.

Measures to secure data Firewalls, DLP systems, UTM, Disk Encryption etc. have been in use for a long time in pharma companies to ensure data security. Aware of the fact that the data security is as important as product manufacturing, the industry is always keen to adopt the latest

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August 16-31, 2016

PHARMA TECHNOLOGY REVIEW

and the most effective solutions in data protection. Regardless of the size of the company, compromise on data security is not permitted or expected.

Kanetkar lists some of effective ways to secure data.

He says, “Implementing a tiered data protection and security model including multiple perimeter rings of defence to counter applicable threats is one of the ways to protect data. Logical (authorisation, authentication, encryption and passwords) and physical (restricted access and locks on server, storage and networking cabinets) security ensures that the confidential data is guarded in the best possible manner. Besides this, data erasure is a method of software-based overwriting that completely destroys all electronic data residing on a hard drive or other digital media to ensure that no sensitive data is leaked when an asset is retired or reused.”

Rajashri Survase-Ojha, Founder and Managing Director, Raaj GPRAC, asserts that besides adopting effective technology, it is important to take some precautions at the human level as well. She explains, “One should know who has physical access to fixed and removable data-storage media and devices. Leverage access logs as well as perform background checks of contractor and third-party personnel who will be handling your data and media. Identify the weak links in your datamovement processes and correct those deficiencies. Datadiscovery tools can be used to identify sensitive data that may not be adequately protected. Avoid letting data security become a bottleneck to productivity, because that is a sure way to compromise a security initiative. The more transparent the security is to those who are authorised to use the data, the less likely it is that they will try to circumvent your efforts.”

Kiran Kumar claims that his company has all the necessary technological tools as well as a security infiltration

36 EXPRESS PHARMA August 16-31, 2016

Around 70 per cent of the data leakages can be attributed to be the handiwork of the existing employees. With around 80 per cent of companies not having a policy that protects the data from the leaving employee makes the situation even more vulnerable

Implementing a tiered data protection and security model including multiple perimeter rings of defence to counter applicable threats is one of the ways to protect data Dr Parijat Kanetkar Consultant, Chemicalli

Joseph Kiran Kumar

Rajashri Survase Ojha

Head - Information Technology, Eisai Pharmaceuticals, India

detection security operations centre (SOC) in Japan which monitors the networks with Palo Alto suite of security tools, but points out that no tool can give 100 per cent security.

Evolving role of technology While many measures are being put into place to ensure this goal, problems persist.

With the widespread adoption of technology, now the onus of preventing data thefts and plugging loopholes in the data security systems now lies with the technology/security solution providers to a great extent.

Ojha narrates some of the technologies which have been implemented by many companies (especially MNCs) for tracking the activities of their employees. She says, “Attendance through Google sheets

One should know who has physical access to fixed and removable datastorage media and devices. Leverage access logs as well as perform background checks of contractor and third-party personnel who will be handling your data and media Founder and Managing Director, Raaj GPRAC

which is also GPS embedded to identify location from where the sheet has been signed in is one way of keeping vigil. VPN Log in/Log out with GPS locator is another option. Use of Employee Monitoring Softwares to track activities of employees who are travelling abroad and what they do on company time is also common.”

Being an MNC, Eisai Pharmaceuticals India’s operations have spread across different countries. Their staff works from different locations/offices with varied kinds of data.

Joseph Kiran Kumar gives the details of the solutions employed by his company. He informs, “USB ports are disabled (except for the data card access). Employees are not allowed to download any software or any executable file as they are restricted only for administrator access. Though

they are free to access the Internet they shall be restricted from accessing the sites that are blocked by the organisation. When a user is working from within our network through VPN additional policies would come in to secure the access. As of now, we haven’t deployed any tool to track their activities. However, an alert from our security operations centre would be sent to the administrators about access to the sites that are not deemed necessary for business. We have a strong information security policy defined as per ISO 27001 standard. A compliance undertaking is usually taken from all the users to conform to the policy.

Strong policies along with the tools can help and deter insiders with malicious intent.”

nies are getting smarter and use more advanced methods/technologies to protect their data. On the other hand, hackers are also coming up with equally strong ways to breach data security.

Kanetkar describes various loopholes in the security system which hackers can exploit to steal the data. He says, “An unencrypted Wi-Fi/LAN system would enable any unauthorised entry to gain access to the main frame. This would also enable the hacker to override the firewalls thereby giving him all administrative controls for taking possession of the required data. Phishing attacks are also observed these days to constantly deceive the viewer/user to reveal their confidential information.

Many homes have a basic, not so strong ISP. This enables potential hackers to gain access to private information.”

With each passing day, drugs are becoming more effective and target-oriented, however the mechanism involved in their development is also becoming very complex.

Data generated throughout the entire R&D process would be enormous and highly unique. The percentage of money spent by the industry in R&D activities has also increased considerably over the last few years. In this changing scenario, there is a surge in the expectations from the data security providers.

Kiran Kumar says, “In future major challenges that the data security service providers should be braced for include security of IOT devices, identity and theft management, mobile data security management, develops security and cloud security.”

He concludes, saying, “There is a common parlance in the security community which says that only two types of companies exist. The ones whose security has already been breached and the ones whose security will be breached sooner or later.”

Challenge to conquer On one hand, pharma compa-

sachin.jagdale@expressindia.com

PHARMA TECHNOLOGY REVIEW INSIGHT

Challenges in serialisation programme and best practices Naveenkrishna Tarur, Principal Consultant Life Sciences Domain Consulting Group, Infosys, elaborates on the need to establish a credible roadmap for serialisation programme by pharma companies NOWADAYS PHARMA companies are racing against time to meet regulatory deadlines. In this absorbing period of uncertainty, budgetary pressures, availability of numerous solution options, technology advancements and options, many a times, companies tend to jump and take a ‘leap of faith’ which often has been observed to land in rework. Hence, it is very important for pharma companies to establish a credible roadmap for serialisation programme after meticulously considering the nature of challenges and due considerations to some of the best practices thereby ensuring higher rate of success of this initiative.

Challenges faced by pharma companies in serialisation initiative Understanding serialisation levels and its interpretation: Serialisation initiative for any pharma company must be global in nature, hence, must be perceived and sponsored as a global programme. Any contrary assessment will eventually lead to a lot of rework and budgetary escalations. Commercially available of the shelf serialisation solutions ranges from L0 to L5 Levels. They start from L0 - printer/scanners to L5 - enabling business partners throughout the supply chain to achieve track and trace capability. But many pharma

NAVEENKRISHNA TARUR, Principal Consultant Life Sciences Domain Consulting Group, Infosys

companies still tend to visualise and restrict serialisation initiative at production line levels. Cost of L4/5 serialisation are equivalent to L0-L3 serialisation solutions for one or two production lines. Thus, by adopting this myopic approach, many companies deprive themselves an opportunity of achieving supply chain excellence through adoption of L4/L5 solutions, which could have come from a medium level of delta investment.

Keeping abreast with regulations Regulatory provisions have been quite dynamic with frequent amendments not just in India but elsewhere. Regulatory reporting, procedures, applicability and timelines have become moving target. This is posing tremendou s level of uncertainty to project teams, resulting in iterations to already established serialisation roadmap. To address this challenge, pharma companies have to identify

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August 16-31, 2016

PHARMA TECHNOLOGY REVIEW their product and market mix, then start with the segments which are procedurally clearer. Many pharma companies are now targeting to go live first with Russia, followed by the EU. Many companies have to place Brazil plans on hold midway to wait for clearer picture to emerge.

Hence, serialisation road map must be flexible and accommodative to such late changes.

SERIALISATION ORGANISATIONAL STRUCTURE

Always evolving and complex global pharma supply chains Today’s pharma supply chains are highly dynamic thanks to dynamic product portfolio, newer compounds making product lifecycles shorter and emerging/ever changing distribution channels, production lines, business partners like 3PLs, CMO, outsourced service providers. For a credible global serialisation capability, pharma companies have to consider all the stakeholders in their supply chain and enable them. They need to be on-boarded right at the programme launch. Survey of partners' IT landscape and their readiness is a very important exercise, if neglected, may jeopardise L4/L5 track and trace programmes.

Diverse IT landscape and processes due to inorganic growth of pharma companies Most global pharma companies have taken inorganic route for growth. Resulting mergers and acquisitions have created localised business processes and their IT shop hosts diverse IT solutions. For a credible serialisation programme, establishing seamless integration with all these desperate ERP and MES systems should be viewed as CSF critical success factor. To enable successful track and trace functionality, companies should ensure fairly stable environment for ERP, ECM, and BI.

Synchronising serialisation programme with other IT programme Serialisation programmes are

38 EXPRESS PHARMA August 16-31, 2016

Serialisation programme should be seen as an opportunity to achieve larger organisational goals like supply chain excellence, brand loyalty and not as regulatory entrusted obligatory goal.

Serialisation roadmap should consider global picture of not just regulatory framework global in nature, hence care must be taken to give primacy to it and also synch up the milestones with that of other programmes that may be running parallel. Projects having dependencies must be planned well ahead of time. If there are large scale renew/rework projects that are running in parallel, key focus must be given to alignment of key milestones of serialisation timelines especially of integration and testing with other tracks.

Some of the best practices we recommend to pharma companies Serialisation programme should be seen as an opportunity to achieve larger organisational goals like supply chain excellence, brand

loyalty and not as regulatory entrusted obligatory goal.

Serialisation roadmap should consider global picture of not just regulatory framework, but also multidimensional aspects like – product portfolio, newer markets, additional production location and lines, ongoing and future IT roadmaps for ERP, SCM, DW. Serialisation roadmap should be pyramidal with strong L0-L3 as base and L4L5 track and trace capabilities sitting on top as global solution, integrating with ERPs, SCM, partner dystems etc. hence they must be interpreted rightly. ◗ L0 Serialisation Solutions ❑Printers and vision systems: Serialisation numbers printed and inspected

◗ L1 Serialisation Solutions ❑Unit level controller and hu-

man-machine-interface (HMI) stations: Serialisation and aggregation data management per station ◗ L2 Serialisation Solutions ❑Line controller: Serialisation and aggregation data management for the entire packaging line ◗ L3 Serialisation Solutions ❑ Site server: Serialisation and aggregation data management for the entire facility ◗ L4 Solution ❑Business planning and logistics: serialisation interface to enterprise resource planning (ERP) and manufacturing execution system (MES) ◗ L5 Solution ❑ Supply-chain track and trace serialisation data event repository

Chart out regulatory requirements and keep abreast with amendments for each country Select service providers preferably who provides L0 –L5, who offers private cloud, able to generate and accept externally generated serialisation numbers, and that offers Global L4/L5 template solution. If your pharma supply chain is limited to select geographies and there is no medium-term plans for expansion, then select the solution provider suitable to this profile, otherwise you would be spending unnecessarily.

Establish a strong serialisation organisational structure For a successful serialisation programme having a strong PMO – organisation structure is very important. It is advisable to set up a Global Serialisation Steering Committee (GSSC), which has direct reports drawn from cross functional global team.

Most importantly, companies should exercise great deal of involvement into this programme than merely reply upon outsourced partner. Hence, sponsors while establishing organisation structure must identify personalities who can run the show and make it happen.

PHARMA ALLY VENDOR NEWS

Spectrum Pharmatech Consultants with RAAJ GPRAC form consortium The venture is aimed to establish a trusted presence in the field of technical and scientific documentation, regulatory affairs and GMP compliance of pharma and biotech industry

S

pectrum Pharmatech Consultants (a Spectrum Group company), a cluster of leading consultancy firms, which provides design, engineering and project management services to various sectors across the globe, and Raaj Global Pharma Regulatory Affairs Consultants (RAAJ GPRAC) have formed a consortium to expand their scope of services to global regulatory affairs, and industrial training in pharma, biotech, CRO, BPO and KPO. The venture is aimed to establish a trusted presence in the field of technical and scientific documentation, regulatory affairs and GMP compliance of pharma and biotech industry.

The consortium will focus to spread and share pharma/ regulatory knowledge vide class room training, and develop qualified professional to work in the pharma and biotech industry and thereby contribute in manufacturing healthcare products of required standards.

The consortium will cover the following scope of services.

I. Validation and qualification ◗ Preparation of validation documents (VMP,EVP,RA,IA)

◗ Preparation of Qualification protocols (FQ,DQ,IQ,OQ,PQ,FAT/SAT) for equipment and systems ◗ Preparation of qualification protocols (SRS, RA, PVP, ERES, HLRA, IQ,OQ, PQ) for PLC, HMI, SCADA, Camera System in Compliances with GAMP 5 and 21 CFR Part 11 ◗ Preparation of quality management systems ◗ Preparation of SOP’s for (production, warehouse, QC, cleaning etc.) ◗ Execution of qualification process at site and final documentation.

II. Strategic services ◗ Strategic assistance in pharma regulatory filing ◗ Support in outsourcing manufacturing or testing laboratories for clients ◗ Support in outsourcing BA/BE study centres ◗ Support in DCG(I) licensing & FDA, CDSCO activities

III. Advisory services ◗ cGMP (current Good Manufacturing Practice) compliance ◗ Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs ◗ Compliance audits as per current and

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August 16-31, 2016

PHARMA ALLY updated statutory pharma regulations ◗ Critical review of dossiers ◗ GAP analysis/due deligence

IV. Technical assistance ◗ Preparation of drug substance and drug product registration dossier ◗ Regulatory filing assistance ◗ Dossier preparation and submissions in CTD [(Electronic Common Technical Document (drug registration)]/eCTD, ACTD [Asian Common Technical Dossier]

◗ Non-eCTD electronic Submissions (NeeS) formats to different health authorities of regulated and semi-regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO ◗ Preparation of gap analysis reports ◗ Drug firm establishment registration with US-FDA [United States’ Food and Drug Administration] (FEI [Facility Estab-

lishment Identifier].) ◗ Drug listing in SPL [Structured Product labeling] format, bulk drug listing ◗ National Drug Code (NDC) and electronic submission ◗ Preparation of DMF[Drug Master Files]/ ASMF [Active Substance Master File]/ CEP [Certificate of Suitability] or (CoS)/ KDMF/ Technical Packages

V. Training and courses ◗ Training and mentoring to professionals in pharma

industry ◗ Conducting training and workshops on RA/QAQM/AD/FD/ICH/CTD/eCTD/A CTD/21CFR parts/ GMP/ GLP/ GCP [Good Clinical Practice]Clinical etc. with case studies ◗ Provide different training modules as per the customer specific requirements in RA, QA, cGMP, GLP, GCP, ISO,2 1 CFR parts, audits, validations, QbD, and many more topics ◗ Provide following different types of training programmes ■ Instructor-led courses

■ In-house company trainings ■ Certificate programmes ■ Distance learning courses ■ Online trainings ■ Fast-track programmes

SPECTRUM in addition to engineering and design, now offers a complete range of services to set up a pharma facility right from conceptualisation till commissioning and further extend our hand holding to our esteemed clients for obtaining regulatory approvals for the facility.

EP News Bureau-Mumbai

Parle Elizabeth Tools opens press plant in Sanand,Ahmedabad The inauguration function was attended by 40 pharmaceutical companies PARLE ELIZABETH Tools, manufacturer of tablet tooling, tablet compression machines, has opened its new factory in Sanand, Ahmedabad. Rajmal L Mehta, Chairman, Parle Elizabeth Tools, India and Dave Keefer, President, Elizabeth Companies, USA, in the presence of Mahendra Mehta, Chief Executive Officer, Parle Elizabeth and the top management from Parle Global and Parle Elizabeth Tools, inaugurated the new facility.

The new facility, one of Asia’s most innovative and efficient tablet press facility combines for the first time the press manufacturing, with in-house Turret and other press parts manufacturing capability. This sprawling new production unit is spread out in 65,000 sq feet of land which will produce 350 tablet presses in a year.

Mahendra Mehta while welcoming the customers and present dignitaries said, “The press business which began six years ago has grown rapidly. We have more than nine models reaching 29 countries. In the process, we have shifted our factory four times. Either we didn’t plan well or we grew faster than expected.

But these were some happy problems to be in and we enjoyed the growth.”

He further said, “I feel confident that with 65 years of Elizabeth and 45 years of PARLE, we have around 110 years of experi-

40 EXPRESS PHARMA August 16-31, 2016

ence to resolve tabletting issues.

As the market becomes challenging and new drugs are invented, our challenge just gets bigger. We just hope that we keep up to the expectations of the industry and update ourselves with the latest technology from time to time.”

Rajmal L Mehta, Chairman, Parle Elizabeth Tools said, “Our product speaks for itself, and we believe that good infrastructure is of utmost importance in order to build an even better product.

Our investment into good environment and technology is only targeted towards one goal, to provide a product to the industry that meets all global challenges.”

He said, “This JV is now eight years old and is growing stronger every day. With their guidance and help, we have taken our tooling division from

domestic leadership to international level in terms of capacity and reach. Our pre and post sales and service team of all our division have proven their excellence time and again.”

Keefer said, “This journey has been an eventful one with various mix experiences and we have seen ourselves growing within Indian and international markets with this great JV between Parle and Elizabeth. The JV with Parle proved not only a correct but great decision which we cherish with every great milestone covered in these eight years.”

V Balaji, Business Head for Tablet Press, Parle Elizabeth Tools India said, “This collaboration helped us make our learning curve steep and deliver new products consistently and in rapid succession. Over this five years, we have grown

from a small 10-member team to a 100+ team in the press division with capabilities built in house for design, manufacturing process, electrical panel building complying to stringent safety norms programming and software development. At the last count, we have sold more than 300 machines and reached 29 countries through our export business. Yet, we are happy to share that the domestic pharma industry has been the one which has given all the first opportunity to build our capabilities.”

Balaji said, “Some of the leading companies catering the regulated market are using our EP series AWC machines. The high output Eco Series has carved a market for itself in companies catering to high output demanding domestic and contract manufacturing plants. The backbone

has been and will be our service attitude and approach supported by a team of your engineers in various pharma manufacturing hubs. Some of the niche areas catered by us are effervescent tabletting, MUPS, hormone tabletting application, bi layer tabletting with high second layer weights.”

Balaji further added, “The installed capacity of the plant on a single shift basis is 350 machines/year and we hope to reach that in the next two years.

We have been entrusted with the responsibility of building Elizabeth Hata Press from this plant and we expect to launch the same during the forth-coming PMEC in 2016. We are also in the process of launching a tri- layer press during that time which can produce bi layer and single layer tablet as well.”

The inauguration function was attended by 40 pharma companies and each of them had an opinion of having this stateof-the-art tablet press facility in India and look forward to see the new machines rolling out from this plant.

The Turret and Press part manufacturing equipment are available from best in the world from Japan and the US which makes this plant the most efficient and with all the production capabilities in house with an unmatched quality.

EP News Bureau-Mumbai

PHARMA ALLY

Merck relaunches customer collaboration centres with new concept State-of-the-art laboratories will provide full endto-end process development support and training

MERCK, A leading science and technology company, is relaunching its global network of customer collaboration centres, providing customers a shared, exploratory environment with scientists and engineers working to solve their toughest biomanufacturing challenges and helping accelerate development of new therapies.

Formerly known as biomanufacturing science training centres, the new state-of-the-art M Lab collaboration centres provide a simulated manufacturing environment for experiments, troubleshooting and problem solving, in a non-GMP setting, that fosters education and full end-to-end process development support. Customers participate in product demonstrations, hands-on training and proof-of-concept work, as well as apply best practices and new approaches to develop, optimise and scale-up processes and simplify global technology transfer.

“These centres have been an important resource for our customers and the biopharma industry for more than two decades,” said Udit Batra, Member of the Merck Executive Board and CEO, Life Science. “Now reimagined and re-engineered as M

Lab Collaboration Centres, we have taken our industry-leading concept to the next level. We are creating unique and inspiring settings where customers can explore new ways to increase productivity and improve processes in close collaboration with our team of experts.”

Merck recently unveiled its first remodelled centre recently in Tokyo.

The network, established in 1995, will also include locations in Brazil, China, France, India, Singapore, South Korea and the US with formal relaunch of centres around the world taking place throughout 2016 and 2017.

Each M Lab Collaboration Centre will welcome customers and collaboration partners from government, academia, regulatory bodies and industry associations, offering application best practices and knowledge sharing tailored to address the specific needs of the local pharmaceutical manufacturers. Customers will have access to sizing and simulation tools and methodologies as well as analytical and modelling support and customer education programmes.

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EP News Bureau-Mumbai

EXPRESS PHARMA

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August 16-31, 2016

PHARMA ALLY PRODUCTS

Huber Kältemaschinenbau launches low-cost cooler for laboratory use THE COOLER HTS-PS1 from Huber Kältemaschinenbau is low-cost and compact cooling solution for the laboratory.

Typical applications include the removal of process heat or temperature control for pipetting elements and bioreactors.

The air-water cooler does not include an active refrigeration unit. Instead, it uses a circulating cycle of cooling water in

the form of a heat exchanger.

Since there is no compressor, the device requires no maintenance, is very quiet, and is also very easy to install. The device offers a cooling power of up to 0.8 kW, depending on the temperature difference between the environment and return temperature. The circulating pump reaches a pumped capacity of up to 8

l/min and a pressure output of 0.2 bar. The HTS-PS1 can be operated over a temperature range from +5 to +80 °C, and is also extremely budget friendly.

Contact details Christine Busshardt Marketing Communications Tel: +49 (781) 9603-250 E-Mail: cbu@huber-online.com

Ingersoll Rand launches IQV20 W5132 3/8”Impactool INGERSOLL RAND, a global leader in reliable and innovative power tools and the official power tools of NASCAR, announced the introduction of the IQV20 W5132 3/8” Impactool, the most powerful cordless 3/8” impact tool on the market.

The IQV20 W5132 has 750 Nm of nut-busting torque and 500 Nm of max reverse torque.

It delivers up to 50 per cent more torque compared to the leading cordless 3/8” impact wrench. It matches the power capabilities of many pneumatic impact wrenches so technicians can get jobs done fast, with less tools. Technicians and operators can use the IQV20 W5132 3/8” and ½” Impactools to quickly loosen and tighten a variety of fasteners with four accurate power and control settings.

The W5132 has 500 Nm of maximum reverse torque and a weight of only 2.3 Kg/2.0 Kg, giving it the best power-to-weight ratio of any cordless impact tool on the market. The tool is available with a 3/8” or ½” square drive and four power and control settings. Each setting operates at maximum reverse torque so technicians don’t need to switch settings to remove a stubborn

42 EXPRESS PHARMA August 16-31, 2016

fastener. The four power modes for forward control include: Full power: Tightening bolts on brake calipers, transmissions, axles and flanges that previously

required a pneumatic impact tool. The full power setting on the IQV20 W5132 impact wrench delivers up to 460 Nm of torque so technicians do not

have to switch tools.

Mid power: The mid-power setting tightens fasteners at up to 325 Nm of torque for applications that don’t require maximum torque speeds.

Wrench tight: Instead of changing to a hand wrench, technicians can use the tool’s wrench tight setting to tighten fasteners at 13.5- to -32.50 Nm of torque. In this setting, the tool automatically shuts off so that bolts are not over-torqued on parts such as suspension bolts, motor mounts, brake calipers, bumper covers, lug nuts, other general maintenance and repair operations (MRO) and assembly applications.

Hand tight: The hand tight setting turns slowly, creating a snug fit for parts such as valve covers, transmission pans drum housings and other light fastening applications at two to nine footpounds of torque. When the tool reaches the point of impact, it also shuts off to avoid overtorqued fasteners.

In addition, the tool comes equipped with a shadowless 90 lumen Chip-on-Board (COB) LED task light that provides a 360-degree ring of light to the area that needs servicing. The

light has four settings for high-, medium- and low-light environments, providing increased visibility and access, as well as an off mode.

The W5132 Impactool features the same high-durability construction as other Ingersoll Rand Impactools. The composite housing is chemical-resistant and features a patented steel reinforced frame for optimal durability.

The compact brushless motor transfers energy efficiently, delivering accurate torque for several repair and maintenance applications including tire and wheel lug nuts, engine bays, brake hubs, axle wheel nuts, interior dashboard components, support brackets, undermount installation and repair, flange bolts, diesel engine repair, machine rebuilds, rail maintenance, industrial machine maintenance, manufacturing equipment repair, machinery installation and equipment disassembly.

The 20-volt battery is compatible with the Ingersoll Rand IQV20 Series battery system.

Contact details www.ingersollrand.co.in.

PHARMA ALLY

Antares Vision introduces Print & Check Flex serialisation unit ANTARES VISION, the world’s leading provider of serialisation-based track and trace solutions for the pharmaceutical industry, has introduced the Print & Check Flex Machine, the most flexible high-capacity serialisation unit on the market. Ideal for maximising the track and trace capabilities of large contract manufacturers, the unit is especially suitable for contract packagers and brand owners running a wide range of formats on the same lines. In other words, those who require the most flexibility in terms of carton dimensions, frequent artwork changes and varying code printing specifications.

The Print & Check Flex is the latest addition to Antares Vision’s Print & Check series of standalone/in-line modules, all of which print fixed and variable data on cartons via inkjet or laser techniques, then check the accuracy and integrity of the printed data. The Print & Check Flex is the only module on the market that combines laser and inkjet printing technologies on up to three printing sides.

With line speeds up to 300 cartons per minute, the Print & Check Flex is designed to handle cartons spanning from 'match box' to 'shoe box' (up to 270x100x200 mm) with weights up to

500 grams. The machine is part of the Antares Tracking System (ATS) 3.0, the third generation of the company’s field-proven platform that has been deployed to over 700 packaging lines worldwide.

The Print & Check Flex includes a labelling unit equipped with thermal transfer printing, a dedicated camera to check the correct label position, integrity and readability of datamatrix and human readable codes, and a builtin tamper evident seal application module. The tamper evident function responds to the authentication strategy of several customers and regulatory/reporting mandates worldwide.

Antares Vision’s comprehensive serialisation solutions, which entail both hardware and software, comprise a range of complementary services including pre-sales activities; installation assistance; training programmes; quality, documentation and validation support; on-site and remote technical assistance; and preventive and planned maintenance service.

Contact details Andrew Pietrangelo Antares Vision (856) 780-3465 Andrew.Pietrangelo@antaresvision.com

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EXPRESS PHARMA

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August 16-31, 2016

PHARMA ALLY

Remi Sales & Engineering launches walk in stability chamber THE REMI walk-in stability chambers are designed for precise simulating, monitoring and control of temperature and humidity conditions required for long term, intermediate and accelerated stability studies at pharmaceutical, chemical, agrochemical manufacturing facilities. These chambers are manufactured as per GMP norms.

They are available in standard or can be tailor made to suit specific requirements. From maintaining of set parameters to documentation, these chambers meet all critical requirements.

Advantages ◗ Maintains precise long-term conditions ◗ Complete solution for simulation of desired temperature and

humidity in the chamber

Performance characteristics

◗ Tailor made sizes as per available space. ◗ Microprocessor controlled refrigeration system and heaters

provide temperature accuracy and reproducible results. ◗ Temperature range 20°C to 60°C, Accuracy ± 1°C. ◗ Humidity range 40 per cent to 95 per cent RH,Accuracy ± 2 per cent RH. ◗ User-friendly LCD screen ◗ Easy-to-read large display. ◗ Integrated data logger for large data storage. ◗ Variety of options for the graphic display of process parameters and utilities. ◗ Real time clock for proper data management. ◗ Electronically controlled humidification system with capacitance type humidity sensors. ◗ Suitable for stability studies according to ICH guidelines. ◗ Sealed Toughened glass view window on door felicitates sam-

ple viewing. ◗ Temperature, humidity and utility failures visual and audible alarms. ◗ Remi 'DATASOFT' data monitoring software as per FDA guideline of 21 CFR Part 11. ◗ Stainless steel racks and trays. ◗ IQ OQ PQ DQ documentation.

Contact details MT D’souza, Product Manager Remi Sales & Engineering Remi House, 11 Cama Industrial Estate, Walbhat Road, Goregaon (East) Mumbai - 400063 Telephone:+91 - 22 - 4058 9888 Fax: +91 - 22 - 4058 9890 Mobile: 9322213105 Email: dsouza@remilabworld.com

Motorised sliding gates by Gandhi Automations GANDHI AUTOMATIONS, India’s number one entrance automation and loading bay equipment company offers a wide range of automated sliding gates suitable to be installed on any industrial, commercial or residential premises. Gandhi Automations is the only manufacturer of gates in India certified to ISO 9001-2008 Quality Management System by TUV Nord. This has resulted in the implementation of continuous improvement in personnel training, production, inspection, equipment calibration, machinery maintenance, logistics and customer relations.

Gandhi Automations designed and fabricated gates to ensure high tensile strength and durability. These gates are not only aesthetically pleasing, but sturdy and perfectly aligned.

The pre-tensioning of the gate leaf construction reduces the risk of bending. The components used to fabricate the gates enhance the efficiency and life span of the gate. The leaf design is

44 EXPRESS PHARMA August 16-31, 2016

switch protects motor and advance electronic control unit permits various operations like time adjustment, partial opening, automatic closing, step by step control, stop safety, reverse safety etc. Sliding gate is also equipped with obstacle detection which causes the gate movement to stop if an obstacle is detected during its motion. In the event of power failure, Gandhi Automations' gates can also be operated manually. A consistent quality product, thus becomes the hallmark of Gandhi Automations' manufacturing process right from installation to after sales service.

available in a standard form or custom made to suit individual clients' requirements.

Sliding gates require flexible automations capable of managing different frame dimensions,

different types of duty and different environmental conditions, always ensuring maximum operational safety, functioning and reliability. The models for automatic sliding

gates weigh from 300 kg to 18,000 kg. MPS startup of the automation at maximum power permits the motor to overcome initial friction caused by ice, dust, etc. Internal thermal

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

PHARMA ALLY I N T E R V I E W

'The plant has a manufacturing capacity of 30,00,000 sq ft of panels and 45,000 doors per annum' GMP Technical Solutions, in its continuing expansion strategy, started its new manufacturing unit (Unit-III) in Bhiwandi recently. The unit was inaugurated by R Vasudevan, its Group Managing Director.

Express Pharma spoke to Ajay Mehta, Director, GMP Technical Solutions on the company's strategy behind opening this unit near Mumbai despite having two manufacturing units in Baddi, Himachal Pradesh What made GMP establish a new manufacturing unit in Mumbai?

As you know, the pharma industry is on a sharp growth path in India. In the past few years, GMP has grown to a leadership position in the cleanroom partitions and cleanroom equipment industry. Since the growth of the pharma industry is expected to be robust in the next 10 years; there was an immediate need to increase the manufacturing capacity of our products to meet the growing demand.

In November 2015, we expanded our existing manufacturing unit in Baddi. This new manufacturing unit (Unit-III in Bhiwandi) is the second level of expansion. The decision of selecting the Mumbai location was purely strategic. It will give us an edge for various markets in India like

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EXPRESS PHARMA

45

August 16-31, 2016

PHARMA ALLY the South, the West and for exports too.

What is the manufacturing capacity of the new unit?

We have designed the plant for a manufacturing capacity of 30,00,000 sq ft of panels and 45,000 doors per annum.

Apart from this, the unit-III will also manufacture 720 units of cleanroom equipment per year. This has lead to approximately 30 per cent increase in our existing manufacturing capacity from our previous two units in Baddi.

What kind of location advantages do you expect from this unit near Mumbai?

The unit’s location was

decided keeping in mind some important markets. We will serve the markets of the South, the West and exports from this unit. This will result in better time commitments and savings in terms of freight, transportation time etc.

We are the only manufacturer with such hitech manufacturing unit for cleanroom partitions near Mumbai. This factor will benefit our clients and in turn, our business.

As you told that the unit will be taking care of majority of South, West and export markets; is there any technological advancement done in this new unit as compared to

the other two units of GMP? Yes! This plant is with the latest technology available in the sheet metal industry. All the major machines are procured from the top known suppliers of the world. It is the only partitions and equipment manufacturing plant to have laser cutting machine procured from Trumph (Germany), turrent punching machine from Amada (Japan). Both these machines have an accuracy level of 0.1 mm. The powder coating plant is procured from Gema (Switzerland), decoiling and roll forming machines from Bulldog (UK) and has automatic bar coding system for all the manufactured products.

How much exports are you planning to do from this new unit?

We are planning to manufacture all export orders from the Unit-III which will save time and inland freight costs too.

However, if there is a capacity concern at some particular stage then the option of Unit-I and Unit-II are always open. We will work on the optimisation of capacity for all three units.

How do you see the cleanroom partitions and equipment market in next five years?

Our expectations from the domestic markets are very high. It will be on a growth path for the next ten years.

However, better government policies and industrial environment are necessary to boost this growth.

As regards to the exports, the markets have become very volatile and unpredictable due to many issues like currency crises, BREXIT, oil prices, civil wars etc. But, we are hoping for good growth in the export markets too in the years to come.

What are the future plans of GMP? We believe in taking actions.

So, it is better we discuss this after taking the decisions. At the moment, we are excited for this new unit and will take all efforts to make it successful.

EP News Bureau-Mumbai

CASE STUDY

HMX-FAAC makes storage of drugs safe and cost effective Encouraged by the satisfactory performance of the previously installed HMX-Ambiator in the raw material warehouse, Himalaya turned to HMX for a feasible solution THE HIMALAYA Drug Company, a leading multinational medicinal drug company, produces healthcare products under the name Himalaya Herbal Healthcare. It has grown manifold and is spread across locations in India and abroad. Today, brand Himalaya is synonymous with safe and efficacious herbal products. Their products are prescribed by 400,000 doctors worldwide and millions of customers trust them for their health and personal care needs.

TEMPERATURE RECORDINGS TAKEN ON MAY 6, 2015, WHEN THE UNIT WAS RUNNING IN 100% FRESH AIR MODE

Unit details

HMX-Ambiator 25k

46 EXPRESS PHARMA August 16-31, 2016

Room

DBT (°C)

DBT (°C)

01.30 pm

36.00

25.00

03.30 pm

34.00

25.00

TEMPERATURE RECORDINGS TAKEN ON AUGUST 7, 2015,WHEN THE UNITWAS RUNNING IN AIR-CONDITIONING MODE

Challenges Himalaya’s state-of-art factory in Bengaluru commenced operation in 2006 and is spread over 200 acres. Its existing finished goods warehouse of approximately 16,000

Ambient Time

Unit details

HMX-Ambiator 25k

Ambient

Room

DBT (°C)

DBT (°C)

01.30 pm

27.00

25.00

03.30 pm

26.00

25.00

Time

square feet area faced issues of maintaining a constant temperature inside throughout the year. This had an adverse effect on the stored finished goods resulting in the reduction of their shelf life.

The ideal environment to store the manufactured goods was to maintain temperatures under 26°C throughout the year. The management had planned to install an 80 TR air-conditioning system to maintain the desired conditions but envisaging the high operational expenditure they started to look for alternate solutions.

Solution Encouraged by the satisfactory performance of the previously installed HMX-Ambiator in the raw material

PHARMA ALLY

The Himalaya Drug Company is quite happy with the performance of the HMX-FAAC unit and the benefits it provides

warehouse, Himalaya again turned to HMX for a feasible solution. HMX carried out an extensive study of the seasonal weather conditions in Bengaluru and found out that the HMX-Ambiator on its own was capable of maintaining the desired conditions for 70 per cent time of the year.

For the balance 30 per cent time of the year, air-conditioning of the warehouse was the ideal solution. As a result an air-conditioning system of only 25 TR was required instead of the originally planned 80 TR. This is when HMX came out with the concept of fresh air air-conditioning (FAAC). It is a revolutionary concept in comfort that brings best of both the worlds of indirect direct evaporative cooling and refrigerated

air-conditioning. The FAAC is designed to provide comfort in all seasons and ideal for applications where maintaining temperature is critical.

This unit would work in evaporative cooling mode when the outside weather is hot and dry and in air-conditioning mode during the monsoon season. The switch between the two modes would be automatic, based on the ambient weather conditions.

Looking at the apparent benefits, the management at Himalaya decided to install a single HMX-FAAC unit of 25,000 CFM capacity with a cooling coil of 25 TR.

Result Temperature readings were taken inside the warehouse after the installation of the HMX-FAAC unit, in both the summer and monsoon seasons.

The Himalaya Drug Company is quite happy with the performance of the HMX-FAAC unit and the benefits it provides.

Contact details ATE Enterprises (Business Unit: HMX) T-126, T Block, MIDC, Bhosari, Pune 411 026 Telephone +91-20-30881100 Ext. 302 M: +91-9158308880 W: www.ategroup.com/hmx CIN: U51503MH2001PTC132921

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EXPRESS PHARMA

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August 16-31, 2016

PHARMA ALLY

IKAdispersers and shakers: An ideal solution for research laboratories Aurigene partners with IKA to enhance its drug discovery and development portfolio AURIGENE IS a specialised oncology and inflammatory disease focused drug discovery biotech, with deep target and therapeutic area expertise.

Based in Bangalore and Hyderabad in India and also in Kuala Lumpur, Malaysia, Aurigene has a fully integrated drug discovery infrastructure from hit generation to preclinical development.

Aurigene’s focus target areas include oncology and autoimmune/ inflammatory diseases. The company works with established pharmaceutical companies by early stage partnerships, licensing and co-development, and specialised services in the areas of crystallography, peptide, small mole-

cule synthesis, non-GMP scaleup and ADME assays.

The challenge To disrupt hard cell walled tissues biotechnology is broadly defined as a technique that uses live organisms viz. bacteria, viruses, fungi, yeast, animal cells, plant cells etc. to make or modify a product, to enhance certain plant or animal traits or to engineer micro-organisms for specific uses. In this endeavour, it is required to isolate the gene, study its function and regulation, modify the gene and reintroduce it into its natural host via another organism and/or vector system.

This process helps facilitate the unlocking of secrets associ-

ated with disease resistance, regulation of growth and development or the communication pathways utilised by cells and among other micro-organisms.

The main challenge faced when homogenising tissues is that many organisms, such as seeds and other heavily encased samples, are not efficiently disrupted chemically or through the introduction of enzymes. In these cases, tissue and cell disruption is very difficult to achieve. Also, the energy needed when using these 'harsh methods' is usually high and destroy the very proteins being sought.

Furthermore, using excessive force is limited because of the generation of detrimental

heat and/or shear that can ruin the desired proteins samples.

Dr Shekar S Chelur, Associate Research Director, Aurigene said, “IKA products are compact with ergonomic designs and are known for reliable performance. IKA India provides good customer support.

Homogenisers with disposable dispersion elements offer great advantage to eliminate cross contamination.”

Advantages at a glance T 10 basic ◗ Ideal for manual operation ◗ Lightweight with ergonomic form and direct mains operation ◗ 125 W drive allows for speed stability with various media

◗ Quick release coupling simplifies changing and cleaning of the disperser element ◗ Stainless steel elements with PTFE bearings suitable for all the methods of sterilisation less time VORTEX Genius (VG 3) ◗ Wide speed range ◗ Special adjustments for microcentrifuge tubes, microtiter plates and Erlenmeyer flasks/conical flasks ◗ Suitable for continuous operation with low heat up due to selfventilation of the motor

The solution The solution is to produce a uniform homogenate in relatively less time.

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PHARMA ALLY

With such resilient samples mechanical and physical methods that rely on grinding, shearing, beating and shocking are used. The most effective method to make a homogeneous mass is still mechanical -rotor/ stator technology. Tissues that are difficult to break down include heart muscle, lung, intestine and skin. The IKA T 10 basic homogeniser comes with a rotor-stator design with an outer stationary tube (stator) and an inner turning shaft (rotor) which is connected to a motor. At the bottom of the rotorstator are slots on both the tube and shaft. When running at 8,00030,000 rpm, samples pressed into the slots of the rotor-stator are efficiently sheared.

The IKA T 10 basic is used to macerate animal and plant tissues of increasingmass. The shearing action of the homogenisers produces a very uniform homogenate in relatively little time.

Sample sizes processed on handheld T 10 basic homogenizer range from 0.5 ml up to 100 ml. IKA offers a range of homogenisers for one to select from - units that can produce a gentle nicking of the cell to release intact organelles in addition to more vigorous disruption to release membrane-bound proteins. Fragile mammalian cells are broken by moderate shaking (500 – 2500 rpm) of the suspended cells using the IKA VORTEX Genius 3 (VG 3) shaker. The VG 3 is a simple device which can be used to mix small vials of liquid or to disperse solids into solution. This unit consists of an electric motor and a drive shaft that is oriented vertically and attached to an inverted rubber cap/ base mounted slightly off-centre.

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It is a versatile product that can be used with three interchangeable attachments and seven inserts for microcentrifuge tubes, microtiter plates and 250 ml Erlenmeyer flasks. IKA VG 3 units also never shut down even when fully taxed and/or when operating at full speed during a given procedure.

Customer benefits Fully flexible homogenisers with a small footprint and quiet operation Aurigene has been using the IKA T 10 basic homogenisers and VG 3 vortex shakers for the past 10 years. They have more than 20 of these units installed in the laboratory setting. IKA homogenisers have helped improve the efficiency and homogeneity of the dispersion process. In addition, these units have increased productivity by saving time through the reduction of the number of cycles by which samples are required to be passed in order to achieve the desired homogeneous phase.

Contact details IKA India 814/475 Survey No.129/1 Mysore Road, Kengeri, Bengaluru – 560060, Karnataka, India Tel.: +91 (080) 26253 900 Fax: +91 (080) 26253 901 info@ika.in www.ika.com

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ADVERTORIAL

Bioanalytical quantitation method for phytonadione isomers in human plasma using LC/MS/MS L Ramalingam, Senior Manager, QPS Bioserve India, Hyderabad, Dr Anoop Kumar, Application Support Manager and Dr Manoj Pillai, Director, Application support, SCIEX India, talk about the objective to develop a rapid and sensitive method that allows cis-and transvitamin K1 extracted from human plasma to be simultaneously determined by a chromatography-mass method

VITAMIN K1, 2-methyl-3[(2E,7R,11R)-3,7,11,15-tetramethyl2-hexadecenyl]-1,4-naphthalenedione, is a nutrient the human body uses to form coagulation factors that aid in normal blood clotting and bone formation [1].

Vitamin K1 exists naturally only in the trans-form. Trans- and cis-isomers are formed during UV-light exposure or synthetic production of vitamin K1. This cis-isomer is considered to have low bioactivity. Therefore, inactive cis-vitamin K1 is necessary to measure individually. The objective of this work was to develop a rapid and sensitive method that allows cis-and trans-vitamin K1 extracted from human plasma to be simultaneously determined by a chromatography - mass method.

Acid in Acetonitrile Isocratic Mode – 4:96 v/v (A:B v/v)

Mass spectrometry

Figure 1: Phytonadione

Conclusions A highly sensitive and high-

Source Parameters Compound Parameters

Sample preparation To 500 µL Spiked Plasma add 1mL of Ethanol and vortex for 1minute to precipitate. Add 2mL of n-hexane and vortex for another one minute. Centrifuge at 4000rpm for five min. Take the organic layer, dry in nitrogen stream at 50ºC and reconstitute in Mobile phase and inject in LCMS/MS system.

Analysis of Cis and Trans Phytonadione was carried out in APCI mode and required different mass spectrometric settings. The MRM transition monitored for Phytonadione was 451.3/186.9. Dwell time was kept 200ms.

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throughput bioanalytical method was developed for the quantitation of low levels of the phytonadione cis and trans isomers in human plasma on the SCIEX Triple Quad 6500 LC/MS/MS System.

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3

219.9

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80

7580034.7

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PHARMA LIFE I N T E R V I E W

Biocon is committed to address skill gap that exists in the industry today Biocon Academy, in collaboration with renowned national and international institutes, has made significant efforts to train biotech professionals. Bindu Ajit, Programme Director, Biocon Academy, elaborates on the newly launched programme, in an interaction with Usha Sharma Recently, Biocon Academy in collaboration with BITS Pilani has commenced admission for the second batch of ‘Applied Industrial Microbiology. Tell us about the success of the previous batch and how is it relevant in today’s time?

The BITS Biocon Certificate Programme in Quality Control Microbiology, a one-of-its-kind programme in microbiology was launched in February, 2016.

In the first batch, 16 students were enrolled. This batch was a great success with 100 per cent placements to all the students in leading pharma and biopharma companies across India. During their graduation ceremony, the visionary chief mentor of Biocon Academy, Dr Kiran Mazumdar Shaw, suggested that the programme should be progressively looked at, with a wider exposure of applications in the industry, thereby widening the scope of the course. From the light of this thought, we expanded the scope of the curriculum taking inputs from the subject matter experts of Biocon and BITS Pilani and named it 'BITS Biocon Certificate Program in Applied Industrial Microbiology.' With this, we strongly believe that the course would be more effective to participants and yield efficient outcomes in addressing the demand for skilled microbiologists as the scope in this field is immense ranging from medicine, pharmacy, diagnostics, clinical research to water industry, agriculture, diary etc.

Besides collaborating with BITS Pilani, are you looking for any more tie ups with other academies and why?

We have an international tie up with Keck Graduate Institute, California for our flagship programme Biocon KGI Certificate Programme in Biosciences and Biocon KGI Certificate Programme in Bioscience Management. Apart from this, many international and Indian universities have approached us for collaboration, post the success of our programmes and understand how relevant industry academia partnership is for the growth of biotech industry. We are exploring options for niche programmes in biosciences.

How will the industry-academia collaboration help the biotech industry to grow faster?

The academia need to revamp their syllabus and introduce new electives which would empower the students to be ready for the industry. For this, we need to work with the industry experts.

Biotech industry is in a growing spree, and requirement of trained manpower is increasing.

Industry academia collaboration brings about a common sense of urgency to support the growth of the sector.

Biocon offers scholarship of 60 per cent as programme fee to all selected candidates.

What is your selection crite-

To subscribe: bpd.subscription@expressindia.com

If India is to emerge as a Bio economy by 2025, we will need to ensure that we have the right quality of talent in the country

ria and who decides on this?

Biocon is committed to address the skill gap that exists in the industry today. We have taken forward our promise of access and affordability to education as well. Hence, we are making high end, very expensive international KGI programme available to students in India having affordable fee. As a part of our CSR initiative, Biocon is extending major part of the fee as scholarship to all the students for the Biocon KGI Certificate Programme in Biosciences as well as the newly introduced BITS Biocon Certificate Programme on Applied Industrial Microbiology. The students who meet the eligibility criteria of our respective programmes can apply for the programme.

They go through a rigorous selection process of HR and technical rounds of interview with a panel of subject matter experts. Once they clear the interview and is selected for the course, they become eligible for the scholarship.

Though a lot of research has been carried in the biotech sector, however, the result is not so impressive. Throw some light on the same The success of the research carried out in the biotech sector is decided based on the congruence between the research that happens in the institutes and corporate R&D labs and how they converge to produce a commercially viable solution. The situation is very positive and with the advent of various grants provided by the

government, the research happening in the academic institutions is turning meaningful and when supported by the incubation centres, becomes a good entrepreneurial ventures.

Biocon has been a pioneer in research and as an innovationled organisation has developed several noble biologics as well as biosimilars. The company has consistently invested more than 10 per cent of its biopharma sales in R&D over the years. At Biocon, the R&D organisation supports the business goals of the company.

In this respect, the investments have resulted in a globally recognised drug development ecosystem spanning state-ofthe-art equipment, a dedicated R&D facility and highly skilled scientific staff. The company’s global scale of bio manufacturing and world class R&D has enabled it to offer affordable biopharmaceuticals to patients across the globe.

Why do you think there is a talent crunch in the Indian biotech sector? Has Biocon undertaken any initiatives to overcome this challenge?

The recent excellent progress in the biotech sector is leading to a demand for high-skilled jobs in India. However, a wide gap exists between the quality of human capital available and the needs of the industry. If India is to emerge as a bio economy by 2025, we will need to ensure that we have the right quality of talent in the country.

Continued on Page 84

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PHARMA LIFE

Biocon is committed to...

Continued from Page 81 The Biotech graduates in India need to be trained effectively to make them industry ready where they can partake in the journey of transforming India through the power of biotech.

The talent crunch is primarily due to the lack of skilled resources who can immediately start contributing to an organisation after graduation.

Biocon has started Biocon

Academy to help generate industry ready talent and offers advanced courses to address the need of the biopharma industry and enable global competitiveness of the sector.

In the last three years, we have successfully placed 200-plus students in top pharma and biopharma companies across India.

How is Biocon grooming biotech professionals for do-

APPOINTMENT

mestic as well as international markets?

India currently has approximately 725 biotech institutions producing more than 40,000 engineering and masters students in biotech streams. However, only about 2,000 of them are employed by the industry every year due to skill gap. Biocon through Biocon Academy in collaboration with renowned national and international

institutes is making significant effort in training biotech professionals through bioscience courses and is being a pioneer in developing industry-ready, high-end talent by equipping bio-scientists with skills that enhance their employability both for domestic and international markets.

Which new courses do you plan to launch and when?

Biocon Academy is engaged in introducing industry focused certificate programmes which are customised after assessing industry needs. In future, we would like to look for topics like immunology, clinical pharmacy and faculty development programme and other niche subjects which would cater to the growing need of the industry. u.sharma@expressindia.com

CAMPUS BEAT

Cipla appoints Kedar Upadhye as Global CFO Upadhye will be a strong addition to the management council, which will help the company to move forward towards its aspirations

K

edar Upadhye has been appointed as the Global Chief Financial Officer of Cipla.

Upadhye is a qualified cost accountant with a follow-on MBA from IIM Bangalore.

He brings with him deep experience of the global generics business. Until recently, Upadhye was the Vice President, Global Generics Finance and Head of Investor Relations in Dr Reddy’s.

Prior to Dr Reddy’s, he has worked with Pepsi India and Thermax Group.

Commenting on his appointment, Subhanu Saxena, Managing Director and Global CEO, Cipla said, “We are pleased to welcome Upadhye to Cipla’s leadership team. With his strong financial expertise and deep insights about the global generics industry, he shall be a strong addition to our

84 EXPRESS PHARMA August 16-31, 2016

Novartis India’s Biotechnology Leadership Camp held in Hyderabad Three winning students will participate in the International Novartis Biotechnology Leadership Camp to be held at the Novartis Campus in Basel, Switzerland

management council to help us move forward towards our aspirations.”

With Upadhye joining Cipla and assuming the responsibility of Global CFO, Umang Vohra will cease to be the Global CFO of the company. Umang will continue to be the Global Chief Operating Officer.

EP News Bureau-Mumbai

MAMTA BHATIA of Symbiosis Institute of Business Management, Pune; N Krishnan of XLRI, Jamshedpur and Rahul Sheshgiri of MVJ Medical College and Research Hospital, Kempegowda Institute of Medical Sciences, Bengaluru won accolades at the recently concluded Novartis Biotechnology Leadership Camp (BioCamp) that took place recently in Hyderabad. The four-day programme saw participation among 51 students vying to represent India at the International BioCamp being held at the Novartis Campus in Basel, Switzerland from August 28 to 31, 2016.

The inaugural address was delivered by Dr Ashfaq Hasan,

Head, Department of Pulmonary Medicine, Owaisi Hospital & Research Centre who spoke on chronic obstructive pulmonary disorder and highlighted the many challenges the disease brings with it. Other speakers included Ganesh Balakrishnan, Partner, Deloitte Touche Tohmatsu India LLP, Prof Deva Priyakumar U, Associate Professor, International Institute of Information Technology and Anu Acharya, CEO mapmygenome.com.

The valedictory address was delivered by Dr AS Soin, Chief Hepatobiliary and Liver Transplant Surgeon & Chairman Institute of Liver Transplantation and Regenerative Medicine, Medanta – Medicity,

Gurgaon. His speech on the way transplant has moved by leaps and bounds gave an insight in to the rapidly changing world of medicine driven by technology. Soin also described the advances in medicine and how the students could play a role in furthering the cause of science.

Congratulating the winners, Jawed Zia, Country President, Novartis India said, “India has consistently produced winners at the global BioCamp. Interacting with such a bright group of students is very stimulating.

Novartis is reimagining medicine and I look forward to you being a part of this journey.”

EP News Bureau-Mumbai

PHARMA LIFE

Announcing Pharma Idol HR Club, an association of 40,000 HR professionals, has launched Pharma Idol, reportedly India’s first and only national pharma quiz contest A LONG standing grouse of HR professionals in the pharmaceutical industry has been the lack of an industry ready workforce. Most pharmacy graduates or pharma business management students recruited need to be put through rigorous hands on induction before they can be assigned any responsibility. After all, these are 'freshers', just out of campus. This requires each pharma company to invest in induction programmes for each batch of 'freshers' hired, tying up senior personnel's time as well as adding to the the organisation's training budget. Can an industry ready workforce be created?

The HR Club, an association of 40,000 HR professionals announce the launch of Pharma Idol, reportedly India’s first and only national pharma quiz contest. According to the organisers, the quiz will pit two member teams from pharma universities, colleges and management colleges, who will be judged by

HR and business managers from India’s leading pharma companies.

Students would receive cash prizes, trophies and certificates. Moreover, the resumes of the top 60 rankers of the quiz would be circulated to the placement partners. Registrations for Pharma Idol kicked off from August 01, 2016 and will end on September 30, 2016.

“Professionals from pharma industry can understand the knowledge and readiness of talent available from these institutions by way of quiz,” says Vijay Dalvi, Associate Vice President – HR, FDC. But what skill sets do pharma companies look for while hiring people? “The students should be aware of challenges the industry is facing due to fixed dosage combina-

tions (FDCs), DPCO, regulation and compliance issues.

The Pharma Idol platform will help them gain knowledge in several areas,” says Dalvi “Academia has been doing a fairly good job on the knowledge front, but the gap is mostly observed in areas of technical skills development including enhancing soft skills abilities of the students. Without an enabling attitude, the employability would be a short lived experience and hence a lot of focus on 'Creating Enabling Attitude' is extended through experiential activities of HR Club. We have observed certain common pitfalls in students' behaviours when they come on-board.

Hence addressing these will surely help these students in their growth and learning in corporate journey. HR Club is bridging the gap between college to corporate through Pharma Idol,” opines Faiyaz Patil, GM-HR, Anglo French Drugs & Industries.

Quiz programmes like Pharma Idol could also attract

attention to pharma companies perceived to be more in tune with the talent at the entry levels. “Pharma Idol is a really innovative idea which The HR Club has launched to get employers and the best talent from India’s top pharma colleges together. Such innovative thinking will go a long way in helping India’s pharma companies get the right talent from the campuses. This will also help the students sharpen their soft skills which is the real key in succeeding in a corporate environment,” says Ranjit Shinde, Senior Manager – HR, Bharat Serums and Vaccines.

The placement partners for Pharma Idol are Bharat Serums and Vaccines and FDC, while the internship partner is Sesderma India. Express Pharma is the Media Partner for Pharma Idol. For more information, contact Krithikha Srinivasan @9892597905 or mail @ krithikha@thehrclub. net EP News Bureau-Mumbai

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