Express Pharma (Vol.11, No.2) November 16-30, 2015

VOL. 11 NO. 2 PAGES 64

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Market ‘We would continue to pursue the cause and case for e-commerce in pharmacies with regulators’ 16-30 NOVEMBER 2015,` 40

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CONTENTS MARKET Vol.11 No.2 NOVEMBER 16-30, 2015 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas

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

Employee Value Proposition: Going the extra mile

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‘WE WOULD CONTINUE TO PURSUE THE CAUSE AND CASE FOR E-COMMERCE IN PHARMACIES WITH REGULATORS’

Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P24: REPORTS Multiple sclerosis treatment market value to reach $20 bn by 2024

RESEARCH

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‘WE EXPECT AS MANY AS 8000 DELEGATES TO PARTICIPATE IN THE EVENT’

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ISCR ORGANISES SYMPOSIUM ON PHARMACO VIGILANCE IN BENGALURU

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PHARMA TECH EXPO2015 HELD IN INDORE

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30TH ANNUAL CONFERENCE OF IPGA HELD IN NEW DELHI

P29: UPDATE FDA approves GSK’s drug Nucala for severe asthma

P31: INSIGHT

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‘OUR TUXEDO STUDY CLEARLY SUGGESTS THAT THE NEW GENERATION EVEROLIMUS STENTS ARE THE BEST IN TERMS OF EFFICACY AND SAFETY’

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‘I WISH MORE PHARMA COMPANIES COME FORWARD TO SUPPORT OUR RESEARCH’

Automation in the downstream: Chromatography column packing

P33: INTERVIEW ‘Single-use system improves sterility’

Scheduling & Coordination Ashish Anchan

P36: VENDOR NEWS

CIRCULATION Circulation Team Mohan Varadkar

Shimadzu & Toshvin celebrate 45 years of partnership

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2015. The Indian Express (P) Ltd. All rights reserved throughout the world.

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

EDITOR’S NOTE

Will new IP policy ensure Sabka Vikas?

I

n our last issue, we highlighted Swati Spentose’s quiet rise to become a ` 40-crore speciality API manufacturer. (See story: Swati Spentose: Small is the next big? in the November 1-15, 2015 issue: http:// www.financialexpress.com/article/pharma/coverstory/swati-spentose-small-is-the-next-big/160972/) Continuing our quest for the hidden gems in the pharma sector in India, we present another one in the November 16-30, 2015 issue: Bliss GVS. Clocking a shade over ` 400 crores in consolidated revenues in FY2014-15, the media shy promoter SN Kamath, who had to be coaxed into a photo shoot, anticipates a growth of 25 per cent in this fiscal, up from 18 per cent y-o-y in the previous year.

Bliss GVS' route to this growth has been to forge an unbeaten path. It chose to specialise in suppositories and pessaries, a dosage form that has never quite taken off in India but has a large following across the world. The company claims to be the world's largest manufacturer of suppository dosage form by volume, with their leading brand contributing to about 40 per cent of revenues. (See story Bliss GVS: Carving out a niche, pages 22-23 in the November 16-30 2015 issue) Companies like Swati Spentose and Bliss GVS reflect the diversity of India's pharma industry, with companies at different stages of their lifecycle contributing to the overall vibrancy of the sector.

There is no doubt that the country's regulations have fostered this growth over the past decades but calls for a global harmonisation of regulations, particularly when it comes to trade, intellectual property rights (IPR) and manufacturing standards, are now getting more strident.

Take for instance, the signing of the Trans-Pacific Partnership (TPP) deal in early October. Ratification by the individual signatory countries has not been a smooth process. Detractors of the TPP in Australia have highlighted how one of the provisions relating to 'investor state dispute settlement (ISDS)' process, allows foreign investors to block governments from introducing legislation that they deem harmful to their business/investment.

The Labour Party and the Greens in Australia have objected to this provision, pointing out that this would effectively mean that the Australian government could be sued for enacting policy designed to protect its environment. This means that governments will have to choose between adhering to the TPP and potentially harming their interests, or facing action.

But countries are forming their own push back groups. After months of tough negotiations by least developed countries (LDCs), the TRIPS Council's decided to extend the transition period from pharma patents and test data protection for LDCs for 17

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The overall impression is that India is on the defensive as far as the IP policy is concerned.Will the government bend to accommodate global trade or push back to 'thwart this grand design’?

years. But health groups point out that this hard won battle is by no means over; it will have to be sustained as individual governments of LDCs will need to use this window of opportunity to build safeguards into their own IP policies.

What will be the impact of such trade pacts?

Dilip G Shah CEO, Vision Consulting Group says that the net outcome would be 'a poorer image of the brand-name industry' while 'the generic industry too will suffer on several counts slowing down its growth and earnings.' In an article published in CPhI Annual Industry Report 2015, titled 'Mega Trade Pacts and Their Impact On the Pharmaceutical Markets', he predicts that the full impact of mega trade deals like the TPP and the Trans-Atlantic Trade and Investment Partnership (T-TIP), in terms of an increase in the price of medicines and healthcare, will be felt by 2020.

Shah also predicts that this success will embolden the United States Trade Representative (USTR) to seek amendments to the TRIPS Agreement and push for more for 'maximalist standards of protection and enforcement in the TRIPS Agreement.' His conclusion however has the kernel of a solution: would BRICS or any other new alignment of the developing countries be able to 'thwart this grand design?’

By all accounts, India's draft national IP policy is doing the final rounds of touching up, and is due to be released this December. Prime Minister Modi himself alluded to it in his speech at the IndoGerman Summit 2015 on October 6 in Bengaluru, assuring the audience that it ‘will be a progressive, and forward looking policy.' This assurance was evidently not enough. In a roundtable at the same meet, concerns were again raised about India's IPR policy and DIPP Secretary Amitabh Kant had to reiterate this message, saying that India would be coming out with 'one of the finest IPR policies' in the world in the next two months.

The overall impression is that India is on the defensive as far as the IP policy is concerned.

IP policy experts have slammed the leaked version of the draft national IP policy, as being 'generic, obvious and lacking in originality' (See Spicy IP blog post by Prashant Reddy: http://spicyip.com/2015/10/16795.html). PM Modi is already on the back foot after the wipeout in Bihar state elections and the winter Parliament session promises to be a stormy one. Will the government bend to accommodate global trade or push back to 'thwart this grand design’? Will the new IP policy ensure Sabka Vikas? We won’t have to wait to long to know the answer.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘We would continue to pursue the cause and case for e-commerce in pharmacies with regulators’ Established in May 2013, BigChemist.com has its own physical store in Delhi and lately has been on an expansion mode. Recently, AIOCD had called for a national strike against online pharmacies in India, Puneet Kapoor, Director, BigChemist.com expresses his views on the issue and how it will impact his business, in an interaction with Usha Sharma

Tell us about the inception of BigChemist.com.

Founded in May 2013, BigChemist.com (A3T Retails) and was conceived on the grounds of giving simple, effective solutions to people in need of online medicines in India. Today, BigChemist offers India's largest range of genuine medicines, healthcare and lifestyle wellness products across categories and all major brands. Our journey so far has been exciting and challenging. We have had more than 3.6 lakh visitors to our site with over 10 thousand registered customers. Our focus for the last two years has been to study closely the healthcare space, understand the key pain point in supply and demand areas, study how the local pharmacies operate, their scope for profitability and revenue increase.

To our understanding, this space offers a huge opportunity with current market size of over $15 billion pharma market with double digit growth rate. We have been focused on developing our B2C platform and

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currently our efforts are on to develop our mobile app (expected to be launched around mid-November) and a B2B platform for supply and demand forecasting fulfilment (expected to rolled-out in the next one year across pan-India).

How many members have their stakes in the organisation and what are their roles?

BigChemist is run by a core team of highly qualified professionals with experience and strong skills in healthcare, pharmacy benefits, technology, operations and customer management. Our team of trained nutritionists, counsellors, pharmacist and product experts help customers in the most professional manner.

Presently, we have five stakeholders in the company, three of us are in management, involved in day-to-day operations and expansion, while the other two mainly provide advisory and guidance to the company management from time-totime. We partner directly

with brands and their authorised channels, to ensure strict quality control and deliver 100 per cent genuine products.

BigChemist has both online presence in www.bigchemist.com and a physical store in Delhi with partner stores in NCR region to service our customers.

BigChemist is run by a core team of highly qualified professionals with experience and strong skills in healthcare, pharmacy benefits, technology, operations and customer management

Recently, AIOCD protested about e-commerce pharmacy in India and called for a day-long national strike. Do you think this will act as a deterrent and will have an impact on your mission and vision?

The strike, if nothing, has initiated a debate on multiple dimensions. This includes regulatory framework, industry practices and understanding of the business model which will help collaborate between the e-commerce platforms and local pharmacies.

We see this as an opportunity to outreach AIOCD and address their concerns for creating a mutually beneficial collaboration for a long-term

MARKET future. We see an opportunity to convey and present how the model will not only impact their sales positively but also help their members with higher profitability and working capital engagement. The ecommerce platform and physical pharmacies together have an opportunity to further create more employment in the sector.

What are your plans if the government bans online pharmacies in India?

Our e-commerce offering covers both medicines, healthcare and lifestyle wellness products. Incase the regulation goes ahead to ban e-pharmacy, we would continue to offer healthcare and lifestyle wellness product range to consumers through our B2C platform.

We would complement the healthcare and lifestyle wellness growth by expanding our current physical store presence from Delhi to other cities for prescription drugs and medicines fulfilment.

We have also collaborated with other healthcare service providers for diagnostics, consultation, nutrition, sports, AYUSH, etc. We would continue to offer these services to consumers through our web and mobile app.

As indicated, we are working on the B2B platform for the healthcare industry.

The model itself offers a large revenue stream in the supply chain fulfilment.

We would continue to pursue the cause and case for e-commerce in pharmacies with regulators as we strongly feel that with the call for Digital India, affordable and quality healthcare can’t be kept out of reach of common people in a vast country like ours for long.

AIOCD claims that there will be a surge of spurious drugs if online pharmacies are allowed in India. What precautionary steps do you follow to ensure that the right medicines are

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delivered to genuine patients?

We operate in strict compliance to Drugs and Cosmetics Rules, Pharmacy Practice Regulations and other Acts while providing the most professional services. We do not sell any schedule X drugs, all schedule H and H1 drugs are dispensed against proper valid prescription with records being kept in digital formats for any future reference as required by the Act. All our products are dispensed in tamper-proof

sales will be through proper taxation with invoices thus enabling better tax collection and control of tax subversion across business value chain.

This initiative will support the neighbourhood and local physical pharmacies by helping them increase their revenue, reach and efficient inventory management.

Eventually it is the inventory stored by them which will be used for servicing the consumers.

Structured customer feedback and rating mechanism will help weed out sub-standard performing

consultation and diagnostics services through our web and mobile app.

Further, we plan to expand our portfolio to AYUSH, patient healthcare records and lifestyle condition prevention programmes. We are highly dedicated to provide quality service. We are passionate about timely delivery and ready availability of maximum range of products.

consultation, diagnostics, digital patient records safe, scheduling, loved ones’ notifications as small but unique services to differentiate us and make a difference in their daily life.

Soon, these services will be extended through our mobile app as well for all their healthcare and lifestyle wellness needs and to inspire our customers to 'Live Big' and experience an enriched life .

Why do you think people should opt for your services when there are so many e-commerce platforms

Pharma companies are facing 'price control order.'

Is it hampering your growth?

No, we offer customers product range across categories. Customers have the option of making informed choices with substitutes and brands. The growth engine comes from volumes rather than prices.

It is the economy of scales which will fuel the growth in future. Also, different brands offer different margins to make up for the low margin offerings.

Currently, we have our own physical store in Delhi with partner stores in NCR. We plan to expand across India by adding partner stores in all major and smaller towns. There are plans to have one signature store owned by the company in all major cities packaging. Our sourcing is only through credible and authorised distributors, stockists or direct manufacturers on proper purchase invoices with product tractability details.

The claims of the strike are mostly unfounded. The chances and threats are equal or less than what persist in the current industry business model.

The technology enables better compliance and implementation of regulatory acts for patient prescription records, product batch and expiry details, product tractability. The integration of technology with commerce will impact the overall healthcare sector, increasing transparency, accountability and elimination of cost-ofpoor quality processes, products and operations.

Due to product tractability, the counterfeit medicines will be reduced in the market place, impacting quality healthcare to the patients. Being electronic in nature, all purchases and

pharmacies and products impacting quality healthcare Presently, how large is your network across India and what are your marketing strategies for further expansion?

Currently, we have our own physical store in Delhi with partner stores in NCR. We plan to expand across India by adding partner stores in all major and smaller towns.

There are plans to have one signature store owned by the company in all major cities where the customers can experience the offerings and share their feedbacks inperson. These stores will also be the hub for inventory and fulfilment.

What medicines are offered by your company? Do you plan to expand your service/product portfolio?

We offer medicines other than schedule X and certain habit forming drugs. We are in process to collaborate with healthcare service providers for offering our customers

available in the market?

What benefits does your company provide?

Our customers chose us for the customer experience we offer – most of all, we listen to our customers. We devise and develop our product range and services for them rather than just be a company offering something.

Our unique loyalty programme 'BigHeart' offers insta rewards, offering a truly beneficial programme with maximum benefit to the customer.

The ease of ordering convenience through web and tele-call, timely and notified delivery, returns and payment options, single click reorder, tamper-proof packaging etc differentiate us from other players. We offer our customers an option to visit us at our physical signature store to experience and interact with the team and see for themselves how we work to service them.

We are in process to offer services such as

What is your manpower strength and do you train them periodically?

Our current manpower strength is 60. We have internal training programmes being designed to train them. We mostly train them through the on-job training model.

Currently, the training is more often as we are still evolving, we expect it take some structured form as we go along and the business model matures further.

Whom do you consider as your competitor and why?

Any company which offers the product range that we offer is our competitor as the customer has the option to buy from them. It really doesn't matter if they are e-commerce or physical store. The difference is in the quality and time bound manner in which the customer is serviced. It is the 360-degree customer experience which separates us from the others in the market place. u.sharma@expressindia.com

MARKET I N T E R V I E W

‘We expect as many as 8000 delegates to participate in the event’ With the 67th IPC to be held in Mysuru, Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India, in an interaction with Usha Sharma, talks about the event's highlights

Tell us about the vision of the 67th Indian Pharmaceutical Congress ?

The 67th Indian Pharmaceutical Congress (IPC) is being organised at JSS University, Mysuru between December 19-21, 2015. I have always considered IPC as the ‘Spirit of the Pharmacy Profession’!

With the theme of ‘Pharmacist for a Healthy India,’ the event will envisage on how pharmacists can play a leadership role in the country, promote and realise the vision of ‘Healthy India’ by 2025.

Strategies from all facets of the pharma sector will be discussed. The pharma industry with the regulatory authorities will discuss how to align themselves with industry standards and ensure that there is a recipe for the growth in the sector. The academia and students will focus on bringing about industryacademia interaction and also ensure quality in pharmacy education so as to prepare an industry ready pharma work force. The practicing pharmacists from the community and hospitals will deliberate on providing medicines to the patients and serve as a bridge between healthcare professionals and the patients to ensure that optimal and correct healthcare

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is delivered properly. All these initiatives will be in the form of round table discussions, symposia, plenary lectures and scientific poster presentations.

How many visitors are likely to participate?

We expect as many as 8000 delegates to participate in the event. About 2000 poster presentations will be held and nearly 72 speakers will participate in the three-day conference and deliver talks which will stimulate discussions and the scientific temper of the Congress.

Early this year, 66th IPC took place in Delhi and now it will be held in Mysuru, twice in the same year. This is going to create history in IPC. How do you feel about it ?

I am excited because the organisers have given an opportunity to JSS University, Mysuru and have shifted their focus from tier I cities to tier-II cities. It will provide pharmacy professionals and students with an opportunity to showcase their talent in organising the event.

Since industry leaders and regulatory authorities from India and across the world will visit Mysuru, it will help to create a positive environment for the development of pharma

The Congress will provide a vision to the country, defining how pharmacists can play a significant role in improving healthcare delivery in India

sector in the region. T here will be challenges since expectations are high. This year, the event will be different from previous ones as leadership role will be provided

by Dr GN Singh, President, IPC and Drugs Controller General (India) DCG(I) and myself. The limited resources that may be available in a tierII city needs to be effectively managed and utilised in a proper way in order to make the event a successful one.

Scientific temper in the present environment and pharmacy education requires some breakthrough outcomes, that would emerge out of this meeting.

IPC will focus on improving the role of pharmacists in India. Which topics and issues are likely to be discussed at the forum ?

The theme of the Congress is ‘Pharmacist for a Healthy India’ – Swasth Bharat. The congress will provide a vision to the country, defining how pharmacists can play a significant role in improving healthcare delivery in India.

This would work out in a manner that the country’s vision of Swachch Bharat and Swasth Bharat as well as ‘Make in India’ is realised; the vision of start-up industries and

Digital India is realised; and the objectives of affordable healthcare (Jan Aushadhi) and safe use of medicines (Pharmacogivilance) is realised.

Focusing on all these visions, a series of talks have been planned by leaders in the pharma industry, academia and the scientific community from India and abroad.

Some of the topics include; ◗ Current tech-trends that are shaping/impacting pharma industry, ◗ Transforming medicine: From bench to bedside and beyond, ◗ Pharmacy education: Lessons learnt and future directions, ◗ Academic leadership: Retrospect, reinvent and redesign ◗ Food, dietary supplement and nutraceuticals ◗ Leadership in providing pharma care through community pharmacy practice.

The 67th IPC will talk about the role of pharmacists in improving patient and health system outcomes through advanced pharmacy practice and help develop a ‘Healthy India – Swasth Bharat’ by 2025. What is the road map to achieve the target ?

The vision and the road map

MARKET has been discussed at various levels and a document will be soon presented at the event by Dr GN Singh, President of the Congress. After receiving the inputs from various stakeholders at the Congress, the document will be finalised.

The broad strategies proposed include: ◗ Industry and regulatory alignment for a new health economy, ◗ Defining pharma care and providing a pharma care policy to be adopted by the pharmacy practitioners (community and hospital) in their practice settings. ◗ Academic leadership that ensures that the pharmacists are competent to rise to the expectations of the healthcare delivery of the country. ◗ Inter-professional communication that would provide seamless care to the patient from physician to pharmacists and to the other health professionals (nurses, etc.) in the implementation of rational and safe use of medicines, ◗ The road map would envisage that the pharmacists at the practice setting who would be interacting with the patient on one hand and the physician on the other hand is competent, knowledgeable and accessible. ◗ Providing pharma care to pharmacists, both at community and hospital settings, will ensure that the patient receives the right dose of medicine at the right time. ◗ Pharmacists will serve as a counsellor and be part of the nation’s healthcare programmes. They will become the major source of dissemination of information and ensure a supply chain of medicine in the healthcare delivery.

profession to the extent to which it would have normally grown if it was implemented in the manner as it is in the developed countries. It has resulted in pharmacists not

being recognised by the healthcare profession as well as the society as a main link between the patient and the physician.

As a result, pharmacists are

not being able to play the role which they should normally do and also not being adequately compensated for the services rendered by them. In this background, Pharmacy

Council of India (PCI) took several steps to ensure that this anomaly is overcome by way of advocacy and also bringing in regulations that would support them. PCI has

Pharmacists play an important role in the Indian healthcare delivery system, however, they are facing several problems. Highlight their key problems and how can they be overcome?

Pharmacists in the healthcare delivery system play a significant role, which is quite often silent and behind the scene. This has not supported the growth of the pharmacy

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MARKET come up with Pharmacy Practice Regulations 2015 which provides empowerment as well as responsibilities associated with the pharmacists and also provisions for their suitable compensation. PCI ensures that pharmacists are provided with an ample opportunity to update their knowledge and skills and introduced B Pharm (Practice Regulations) 2015 which is the bridge course for working pharmacists with a Diploma in Pharmacy to upgrade and become a graduate in pharmacy besides understanding the advances that have taken place in the pharma sciences and practice.

The PCI had also introduced PharmD Regulations 2008 to provide professionally specialised clinical pharmacists for offering care that is unique and supportive of healthcare delivery. The council continues to put its efforts to address difficulties

Communication Technology (ICT). It will help to stimulate the process of thinking and innovation in young minds rather than just learning or acquiring the basic skills that they would need their careers.

PCI has made regulations in B Pharm and M Pharm in a way where there is a provision for continuous updation of curriculum without regulatory hurdles faced by the pharmacists.

If the government gives the green signal for online pharmacies in India is it likely that the number of chemist shops would reduce?

If yes, will it create job scarcity in the sector? Are we prepared to handle such a scenario?

Access to medicines is the right of a patient. Providing the right medicine with proper counselling is the responsibility of the pharmacists. As long as the patient has access to medicines and the pharmacist is delivering and providing

associated counselling and pharma care, there should not be any major issue. We have to dispassionately look at the needs of the patient and ensure that these needs are provided by a competent person.

The role of pharmacists is not diluted in any manner, irrespective of the mode of delivery of such need and care.

Hence, the scarcity of jobs should not be there and in fact would give rise to more job opportunities to be delivered in a manner that is more professional as you would be targeting a learned community to provide the said care and

services.

Which new courses / programmes do you plan to announce during the event?

Pharmacy Council of India will unveil a detailed curriculum for B Pharm and M Pharm courses, i.e. current, relevant and contemporary.

Recommendations will be made to deliver the curriculum in semester/annual system, which will be on a choicebased credit system.

Suggestions will be made on extensive use of teachinglearning methodology that would rely on Information

Which curriculum needs urgent upgradation and why?

The curriculum at both B Pharm and M Pharm level needs to be updated continuously. PCI has made regulations in B Pharm and M Pharm in a way where there is a provision for continuous updation of curriculum without regulatory hurdles. The council’s endeavour will be to provide the most current and relevant curriculum. Such an effort is needed as pharma sciences and practice are continuously evolving and the curriculum also needs to be dynamic. u.sharma@expressindia.com

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MARKET POST EVENTS

ISCR organises symposium on pharmacovigilance in Bengaluru Discussions were held on to assess emerging pharmacovigilance requirements in India INDIAN SOCIETY for Clinical Research (ISCR) recently conducted second national pharmacovigilance symposium in Bengaluru. The symposium saw a number of pharmaceutical and regulatory professionals to discuss current issues, gain greater understanding of existing needs and assess emerging pharmacovigilance requirements in India.

Key stakeholders from the

industry, academia, government and the not-for-profit sector and healthcare representing different perspectives deliberated on current requirements, recent advances in regulations, best pharmacovigilance practices and opportunities and challenges in effective management of outsourced pharmacovigilance operations.

Dr J Vijay Venkatraman,

Chair, ISCR PV Council, in his opening address, stressed on the need for all stakeholders to work in harmony for the betterment of Indian pharmacovigilance. The inaugural speech was given by Dr Darshan Bhatt, Chief Guest, who is an independent consultant and well known pharmacovigilance professional in the country.

The inauguration was followed by panel discussions that

saw pharmacovigilance experts deliberate on 'Pharmacovigilance in clinical trials' and Post Marketing: India Perspective; Pharmacovigilance from Bench to Bedside; Recent Advances in Global Pharmacovigilance and Pharmacovigilance Operations: Opportunities and Challenges.

The key takeaway was that pharmacovigilance is an important area associated with the

entire lifecycle of a drug but it needed to be more transparent in order to provide updated information to stakeholders.

There was a need for more awareness and capacity building and a greater deployment of technology to capture information. India had the expertise and potential to develop a robust pharmacovigilance system for the country.

EP News Bureau-Mumbai

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Pharma Tech Expo2015 held in Indore CDSCO likely to set up CDTL in Indore Usha Sharma Indore INDIAN Pharmaceutical Association (IPA) (MP State Branch) and PharmaTech recently organised a threeday seminar and exhibition, Pharma Tech Expo2015 at Brilliant Convention Centre in Indore. Speakers addressed various regulatory requirements of India as well as regulated markets.

Ramesh Agrawal, President, Federation of Madhya Pradesh Chambers of Commerce and Industry (FMPCCI), the Chief Guest of the event, while speaking at the inaugural session of the seminar, encouraged the investors to invest in Madhya Pradesh. He also mentioned that the state has adopted online application methods for conducting most of the government activities.

Dr K Bangarurajan, Deputy Drugs Controller (India), Central Drugs Standard Control Organization (CDSCO), West Zone Mumbai, who was present on the first day said that the Indian pharma industry has the potential to deliver quality medicines to the world, but fails to maintain data documentation. He also informed, “Presently, Indian pharma companies manufactures ` two lakh crore worth of medicines and export to nearly 214 countries. Also, India largely exports to the US market which is highly regulated.”

Bangarurajan emphasised the fact that the pharma industry plays an important role in attracting foreign investements to the Indian market and the government is serious and very enthusiastic under the 12th Five Year Plan. The government has sanctioned an amount of ` 1700 crores for strengthening CDSCO of which ` 1000 crores would be in-

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vested in setting up a Central Drugs Testing Laboratory (CDTL) and strengthening manpower.

Bangarurajan announced that CDSCO has planned to set up a CDTL in Indore, for which the construction work is likely to be commissioned early next year. He also mentioned that CDSCO will have offices in all the states which will help streamline the regulations. He also stressed on the need to comply with good manufacturing practices.

While delivering a lecture on WHO GMP Certification – Regulator’s Expectation, Bangarurajan presented a list of expectations and procedures, which the Indian pharma companies need to follow in order to pursue an application. He also spoke about WHO-GMP procedures and its importance in exports and data integrity problems.

Dr RS Rijhwani, Chairman of Industrial Division, IPA, welcomed the delegates and said, “The prime focus of the show is to uplift the pharmacy profession in India and we will work in line with the Prime Minister's vision of ‘Make in India’campaign. He said, “Seeing the growth rate of pharma exports, we have a lot of potential to grow. To avoid any regulatory issues, we need to channelise things properly.”

Dr Subhas C Mandal, Directorate of Drugs Control, Government of West Bengal and Vice President Chairman, IPA - Regulatory Affairs Division, spoke about the relevance of the seminar in today's scenario. He said, “We used to talk about technologies and innovations but now we see more discussion on pharma production.”

Dr Rao VSV Vadlamudi, President, Indian Pharmaceutical Association said that In-

Dr K Bangarurajan, Deputy Drugs Controller (India), Central Drugs Standard Control Organization (CDSCO), West Zone Mumbai

Ramesh Agrawal, President, Federation of Madhya Pradesh Chambers of Commerce and Industry

dian pharma companies which are manufacturing and marketing drugs for the global pharma market need to work aggressively towards providing quality medicines. With the help of pharma professionals, IPA can

provide quality healthcare which will help in reducing mortality and disease burden.

Dr Maharukh Rustomjee, Consultant – Life Science and Healthcare and Founder Director, Rubicon Research, gave a

glimpse of the regulatory developments since the last 15-20 years which have led to a continuous shift in the quality paradigm.

Abha Pant, President -R&D (Formulations) IPCA Laboratories talked about the expectations of regulatory agencies.

She stressed on to minimise the difference of the western world and the Indian market.

She also pointed out that apart from solid dosage drugs form, biologic, transderma etc will soon be off patent. Moving on, she raises the query that if Indian pharma companies are finding it difficult to produce documents for solid dosages then how are we going to tap forthcoming business opportunities?

She also highlighted the challenges that the Indian pharma companies are facing, where both Indian states as well as central authorities are issuing approvals whereas in other markets, a single authority has been deputed. “Besides these, there are a number of divisions and sub-divisions under our ministry, which I feel should become one authority,” suggested Pant. She also pointed out that today a number of approvals are needed before conducting research and development, which is a time consuming process. Signing off, Pant said that the industry should become a member of International Generic Drug Regulators Pilot (IGDRP).

On the second day of the seminar, Sanjay Tiwari, Director – Pharma Manufacturing, Sun Pharmaceutical, significantly mentioned that India and China stand top of the list of the US FDA’s 483 list. He also highlighted that data integrity is the key reason why most of 483s are given to pharma companies. Moving

MARKET forward, he suggested that there is a need to have periodic inspections to avoid such problems.

Amit Saxena, General Manager - Corporate Quality Project Manager, Sun Pharmaceuticals said that internal audit is important during laboratory operations.

Dr Subhas Pande, Senior Vice President, Corporate Quality Assurance, Cadila Healthcare conveyed the message to the audience that there is nothing to worry about the US FDA observations and companies can follow compliance procedures.

On the last day of the seminar, the DOTS-TB Training Programme was held. A daylong session was organised for retail chemists on how to eradicate TB cases in India.

The programme was attended by nearly 50 chemists, where they were educated on how to create awareness about the

disease and also about the government's initiative to offer free medicines to the patients.

Manjiri Gharat, Vice President Chairperson, IPA Community Pharmacy Division, DOTS TB Pharmacist Project Leader briefed about the programme and mission of the agenda to all retail chemists.

Dr Atul Kharate, MP State

TB Officer, Joint Director Health Service, informed about the current status of TB cases and initiatives being taken by the state government. While sharing details, he said that presently there are only six Cartridge-Based Nucleic Acid Amplification Test (CBNAAT) TB detection machines available and in next two months the state will get 70 new ma-

chines. Presently, the tests cost ` 2000 each at private institutions while it will be done free of cost at the DOTS centre Dr Vijay Chhajlani, District TB Officer, Indore requested all the chemists to report TB cases and help the state government in identifying the cases and improve the health of TB patients in Indore. He also urged pharmacists to not

dispense phenoline medicine to random patients, as they are to be dispensed based on prescription. He aims to see Indore TB-free by 2020.

Ramesh Shah, Managing Director, Pharma Technology Index thanked the exhibitors and visitors for making the event a successful one. u.sharma@expressindia.com

Partikelmess- und Analysesysteme

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MARKET

30 Annual Conference of IPGAheld in New Delhi th

Attended by more than 700 delegates from across the country THE 30TH Annual Conference of Indian Pharmacy Graduates’ Association was recently held in New Delhi. The conference was presided over by Atul K Nasa, President of Indian Pharmacy Graduates ‘Association (IPGA) and was inaugurated by Dr GN Singh DCG(I), which was attended by more than 700 delegates from across the country.

Dr GN Singh called upon the pharma industry to take advantage of the opportunities being created by the government through the scheme of ‘Make in India’, by investing in making medical devices indigenously.

At present there is a big and growing market for medical devices in India but it is importing about 90 per cent of its consumption of medical devices.

There is a big opportunity for the pharma sector to make medical devices not only for our consumption but to look for export as well so that India can dominate in this field as well, he said.

Singh added, “India, at present, is at the fourth position by volume and at the ninth place by value of the total sales of medicines of the world. India is producing medicines worth about ` 15,000 crores by over 8,000 pharmaceutical plants and is exporting to more than 210 countries. India is the largest producer and exporters of vaccines and is supplying vaccines to WHO also for their vaccination programmes in developing countries.

BR Sikri, Managing Director, ABS Mercantile, said that it is a proud moment for pharma industries as every third tablet being used world over is being manufactured in India but at the same time 80 per cent of the materials required in this regard are being imported from China. He emphasised the need to make them indigenously and reduce the dependency on one country for these products.

Dr Mrinalini Darswal, Food Safety Commissioner & Drugs Controller, Delhi, who was also

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(L-R): Dr Arun Garg, Atul Nasa, Dr GN Singh, Vijay Bhalla, Bhanu Dua, PK Dutta, Dr Mrinalini Darswal, Dr B Suresh

(L-R) Bhanu Dua, Atul Nasa, Dr Mrinalini Darswal, Dr GN Singh, Dr B Suresh, PK Dutta, Dr Arun Garg

the guest of honour, graced the occasion and congratulated the association for choosing the theme of the conference on digitalisation and said that this technology could provide better service to public. Dr B Suresh,

President, Pharmacy Council of India (PCI) delivered the key note address and presented his views on digitalisation of pharmaceutical services. Other dignitaries who graced the occasion were Dr SS Aggarwal, Vice

chancellor of Delhi Pharmaceutical Sciences & Research University, and PK Datta, Managing Director, Systopic Labs.

A job fair was also organised for the first time during this conference where more than

100 candidates were interviewed by seven pharma companies and around 30 candidates were shortlisted for the job.

IPGA felicitated Singh for being elected as the President of 67th Indian Pharmaceutical Congress and Dr SS Agrawal on being appointed as the first Vice Chancellor of Delhi Pharmaceutical Sciences and Research University.

Atul Kumar Nasa, President, IPGA was honoured with IPGA Professional Excellence Award. IPGA Life Time Achievements Awards were given to PP Sharma for 2014 and to Bhanu Dua for 2015.

IPGA Promising Pharmacist award was conferred to Pradeep Kumar.

These awards are given by IPGA every year for the exemplary services given to pharmacy profession to their members.

The newly constituted IPGA best state branch award was given to Bihar State branch and IPGA best local chapter award was given to Mathura Chapter. IPGA honours the first three toppers of GPAT every year and this year the awards were given to Ashish Girdhar, Jojo Joseph and Rajat Mahajan.

The IPGA fellowship Awards for 2015 were bestowed to Dr Bhagirath Patel from Gujarat, Dr MN Rao Gupta of Andhra Pradesh, Binod Kumar from Bihar and N Udupa of Manipal.

During the scientific session, various eminent speakers from all across the country delivered their highly informative and interactive talks on the theme ‘Role of Pharmacists in Digital Era.’ They stressed the importance of digitalisation in various activities of pharma science such as research and development, production, pharmacy practice and patient care.

The vote of thanks was given by Dr Arun Garg, General Secretary, IPGA. EP News Bureau-Mumbai

EVENT BRIEF NOVEMBER 2015 - JANUARY 2016 19

Advanced Techniques & Applications of Mass Spectrometry

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OTC Pe Charcha

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CPhI India

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National Conference on Drug Discovery & Therapy

ADVANCED TECHNIQUES & APPLICATIONS OF MASS SPECTROMETRY Date: November 19-20, 2015 Venue: Ramada Powai Hotel & Convention Centre, Mumbai, Summary: SELECTBIO will organise its 2 nd international conference ‘Advanced Techniques & Applications of Mass Spectrometry.’ Experts will cover various advanced techniques followed by novel applications of mass spectrometry in analysis of pharmaceutical and forced degradation products, metabolites, food, environment, forensic, clinical and biological samples.

In addition, a workshop entitled ‘Mass Spectrometry for Clinical Analysis’ is scheduled to be conducted by Dr Nigel Brown, Consultant Clinical Scientist, Wansbeck General Hospital on the second day.

Contact details Sakshi Modgil Customer Services Manager, SELECTBIO India, Tel: +91 172 5025050 Mob: +91 7696 125050 Email: s.modgil@ selectbio.com

OTC PE CHARCHA Date: November 27, 2015 Venue: Sofitel, Mumbai Summary: Cube X, a division of Sorento, will organise ‘OTC Pe Charcha.’ Visitors at this year’s OTC conference will come face-to-face with firsthand consumer insights, expert views and successfully executed strategies in the OTC arena.

Contact details Prashansa Bora email: pbora@cubex.co.in, Tel (D): +91 022 4036 2037 (B): +91 022 4036 2000

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India Pharma 2016

pharma manufacturing technologies, will be beneficial to all participants from local business associates to international machinery manufacturers and API / bulk active manufacturers. through participation at the exhibition. During APE 2015, 492 exhibiting companies from 28 countries along with 8,500 square metres of floor space and 9,000 trade professionals visited the show.

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

CPHI INDIA Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai Summary: Key decision makers in the pharma industry from 92 countries, including India, China, the US, the UK, France and Italy will participate. Visitors will be able meet all major suppliers of pharma ingredients, outsourcing, equipment and biosolutions in one location. PMEC, ICSE and BioPh will be co-located with CPhI event.

Contact details UBM India Times Square Unit No. 1-2, 5th Floor, ‘B’ Wing, Andheri Kurla Road, Marol, Andheri (East) Mumbai – 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

NATIONAL CONFERENCE ON DRUG DISCOVERY & THERAPY Date: January 7-8, 2016 Venue: Department of Biochemistry and Biotechnology, Annamalai University

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Summary: Department of Biochemistry and Biotechnology, Annamalai University will organise National Conference on Drug Discovery & Therapy (DDT-2016). The conference will provide an excellent forum for sharing research results and interaction/ discussion for the scientists and students working in the area of drug discovery research.

Contact details Dr N Rajendra Prasad, Assistant Professor, Dept of Biochemistry & Biotechnology,Annamalai University, Annamalainagar 608 002 Tamil Nadu Tel: + 91 4144 – 238343 Fax: +91 4144 – 239141 Mob: + 91 9842305384 Email: drprasadnr@ gmail.com

INDIA PHARMA 2016 Date: January 7-9, 2016 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: Department of Pharmaceuticals, Ministry of

Chemicals and Fertilisers, Government of India with FICCI will provide a platform to global investment community to connect with stakeholders in the pharmaceutical sector in India, central and state governments, leading business leaders and top executives from the industry, academics and experts from the world.

The event will cover the whole process of pharma manufacturing, from various kind of manufacturing/processing machineries to lab equipment, analytical instruments, APIs and other total solutions.

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

ASIA PHARMA EXPO 2016 Date: January 28 to 30, 2016 Venue: Dhaka, Bangladesh Summary: Asia Pharma Expo 2016 (APE 2016), the 8th international exhibition on complete

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

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

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20 EXPRESS PHARMA November 16-30, 2015

(

THE MAIN FOCUS

In three decades, Bliss GVS has emerged as a ` 400-crore niche player in suppositories and pessaries

BY USHA SHARMA

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EXPRESS PHARMA

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cover )

T

he ` 407-crore Mumbai-based Bliss GVS Pharma is into developing, manufacturing and marketing high quality pharmaceutical formulations. The company specialises in the manufacturing more than 40 formulations in suppositories and pessaries for international as well as domestic market.

The journey so far In the year 1984, Bliss GVS was incorporated as Bliss Chemicals and Pharmaceuticals India, driven by four stakeholders. In 1986 the company launched its flagship product ‘Today' – Vaginal Contraceptive which became their blockbuster drug. Later in 2004, SN Kamath, the present-day Managing Director of the company, along with Gautam Ashra, Promoter, took over the company and in 2006, both of them decided and re-established the company and coined it as Bliss GVS. Recalling those days, Kamath says, “When I and Ashra decided to take over Bliss Chemicals, we both were convinced with the company's potential and its products' capabilities.” Moreover, he informs that he had the right background as he started his career with an anti-malarial product in the African market.

In 2007, the company commissioned its manufacturing unit for tablets, dry syrups at Palghar in Maharashtra. This facility provided a boost to the company's growth and in 2010 it opened a new state-of-theart manufacturing facility for suppositories and pessaries in the same premise at Palghar.

After coming up with the facility, the company applied for EU-GMP approval and received it in 2011.

Since its inception, Bliss GVS has always followed an organic approach for its growth.

22 EXPRESS PHARMA November 16-30, 2015

THE MAN BEHIND THE ENTREPRENEUR In 2012, the company acquired 70 per cent stake in Kremoint Pharma to strengthen its presence in the dermatology segment. The acquisition helped the company expand its product portfolio and led to the setting-up of a manufacturing unit for dry powders for injection, ampoules, eye/ear/nose drops and nasal spray.

The company continued to expand and in 2012-13, it set up a new research and development centre in Andheri, Mumbai for developing new formulation dosage forms of suppositories and pessaries.

The centre has received an approval from Department of Scientific and Industrial Research (DSIR), Government of India.

Today, the company supplies to renowned domestic and multinational pharma companies like Sun Pharma, Boehringer Ingelheim etc “Currently, we have more than 200 products across 20 therapeutic categories and 16 dosage forms.

There are more than 15 products in pipeline which would be commercialised in the next financial year,” informs Kamath.

Bliss has emerged as a reliable name in the suppositories and pessaries and today its blockbuster drug called, Lonart, gives approximately 40 per cent of the company’s total business which changed to over ` 100 crores.

Business driver Bliss GVS has its presence in more than 64 countries. Being an export-oriented company, almost 95 per cent of the revenue is generated from exports. Talking about the company's business focus, Kamath highlights, “Bliss GVS’s focus has always been on creating brands in various countries that we have been operating across various therapeutic segments like anti-malarial etc.

While speaking about how he spends his leisure time, Kamath inspired by saying,“Leisure time is a luxury but I love spending my free time in interacting with people and exploring new business opportunities.

And whenever it is possible, I like catching up on the latest action movies released especially during long haul flights.” and dosage forms like suppositories and pessaries etc. Suppository is a niche dosage form and hence the potential of this

market has been largely untapped.”

If suppositories have huge business potential than why

aren’t any other Indian pharma companies exploring it? Is it because medical representatives are finding it

( difficult to educate doctors or do companies lack awareness?

Replying to the question, Kamath states, “Indian patients have traditional mindsets and are a bit rigid about opting for such methods. It has been found through our own experience that promoting suppositories to doctors has traditionally been very difficult.

Although doctors are convinced that suppositories are superior to other conventional drug delivery system, they find it difficult to explain to patients how to administer this dosage form in vernacular languages. However, due to increased awareness about safety and efficacy of suppositories, we see a continuous increase in demand in the domestic as well as international markets and we are confident that overall market for this dosage forms will continue to grow at a faster pace.” He further elaborates, “Suppository as a drug delivery system is being used to deliver a wide range of drugs cutting across therapeutic segments for local as well as systemic effect. Due to superiority and convenience of suppository as a dosage form it can be used to deliver drugs in a wide range of therapeutic categories like anti-fungal, contraceptive, laxative, anti-haemorrhoidal, anti-spasmodic, antipyretic, analgesic, anti-malarial etc. There is a positive growth across all these categories in the Indian market and hence this drug delivery form can be a rewarding asset for Indian pharma companies with good marketing infrastructure.”

Moreover, this system also offers several benefits. SR Vaidya, Director, Bliss GVS informs that this form of drug delivery has no side effects on the human body as it bypasses the GI system and works effectively on the ailment.

Thus, the company sees a lot of potential in this segment and has been concentrating its efforts to leverage the growth opportunities.

Manufacturing facilities Presently, the company has six manufacturing facilities including one R&D Centre in Mumbai. “Our manufacturing facilities are certified to be cGMP compliant by local and international standards EU GMP, WHO GMP, ISO14001, OHSAS-18001,” informs Kamath.

Bliss GVS's R&D centre employs 50-plus scientists and plays a crucial role in fuelling the innovation culture in the organisation. The R&D lab follows stringent guidelines based on good laboratory practices and is well equipped with upto-date equipment like particle size analyser, gas chromatography, high performance liquid chromatograph, dissolution tester, stability chamber and lab scale manufacturing machine.

Kamath informs, “Bliss GVS leads the suppository market in India by marketing its own brands and contract manufacturing for major pharma companies. To cater to the growing demand we have recently enhanced our production capacity and we are now the world’s largest manufacturer of suppositories dosage form by volume. This manufacturing capability is complemented by a state-of-the-art R&D centre located in Mumbai having more than 50 scientists focusing on developing suppositories and pessaries. We are a leading organisation in India for contract development and manufacturing for suppositories and pessaries for regulated markets.”

The company's growth trajectory shows it is doing phenomenally well in its domain and heading towards further success. It is expanding its international reach as well.

International presence With a product basket of 200 in the existing therapeutic areas, the company is planning to expand its reach in the regulated markets as well. Presently, it exports its products to over 60

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SUCCESS MANTRA The company does not spend much on marketing and branding activities and still catches people's eye.When we asked about the company's success mantra, Kamath revealed,“Our dayto-day actions are guided by four guiding principles, Identify right people and continuously invest in their skill enhancement, continuous innovation in the product offering to meet emerging market demands, strategic alliances for sourcing and marketing the products and focus on building brands.”

countries and has established a strong presence in the African market. While disclosing the company's business activities in the African region, Kamath elaborates, “While we were focusing on building brands in the finished formulations space, we found a huge gap in the quality of healthcare

THE MAIN FOCUS

services in Africa. As Africa has given us an opportunity to grow, we wanted to do our bit for this under-served region which made perfect business sense as well. Thus, we decided to contribute towards improvement of healthcare infrastructure by deploying latest technology in the area of radio-diagnostics like MRI, CT scan and other ancillary diagnostic services like biochemistry, pathology etc, while also adding a gamut of clinical services provided in our healthcare clinics. In a very short span of time, we have started diagnostic centres and chain of clinics in multiple countries of Africa.

We are working closely with leading insurance companies in managed healthcare services which would eventually help us in making quality healthcare affordable to general masses in various African countries as we continue to scale up our operations.”

Presently, the company has 30 + health clinics in Kenya and are planning to set up 150 more clinics in 47 African countries in the next 9-12 months. Commenting on how the company is managing to drive down the cost and encourage the healthcare service in Africa, Kamath states, “We have tied up with an insurance company in Kenya to bring down the cost of healthcare service and help patients avail quality service.”

It has opened two diagnostic service centres in Nigeria and are planning to expand those centres. the company also plans to set up such centres in Nigeria and its neighbouring countries.

The company has business plans for the semi and highly regulated markets as well.

While sharing details on that, Kamath discloses, “We have already received multiple approvals for our formulations in suppositories and pessaries dosage form in regulated markets. Our product registration dossiers have been submitted in various regulated markets and we anticipate more regis-

tration in the next fiscal. (We plan to have) products which are a strategic fit in the regulated markets while in semiregulated markets, we have increased our pace of dossier submissions for registrations in South East Asia, CIS, Africa and LATAM.”

Plans for future growth During the fiscal year 2014-15, the company's consolidated revenue increased 18 per cent y-o-y basis to ` 407.13 crore.

“We are aiming to achieve a growth of 25 per cent for the current fiscal year,” informs Kamath.

He continues further, “Our plan has always been to identify, develop and market niche products and would like to continue with it. We are now planning to have strategic tie-ups with Indian and European companies for in-licensing and out-licensing of products. We are also planning to get associated with strategic partners like large insurance companies in managed healthcare services in Africa.”

Further, the company has plans to invest ` 40 crores to set up a new manufacturing facility in Palghar for tablet and capsules. It is likely that the new facility will be commissioned by the end of 2016.

The manufacturing capacity of the new facility will be approximately 2.5 billion per annum for tablets and capsules.

“To cater to the growing market demand, we have planned for a new manufacturing facility for oral solids. This greenfield project would be funded partially from accrued profits and we may decide to raise finance for further expansion, should there be a need. This new facility would be commissioned in FY 16-17,” informs Kamath.

Thus, Bliss GVS has really come a long way and intends to scale greater heights in the coming years, helmed by its able leader, SN Kamath. u.sharma@expressindia.com

EXPRESS PHARMA

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MANAGEMENT REPORTS

Multiple sclerosis treatment market value to reach $20 bn by 2024 The growth will primarily be driven by the continued uptake of premium products and an increase in treatment rates as a result of the availability of novel alternatives THE VALUE of the multiple sclerosis therapeutics market will rise slowly from $17.2 billion in 2014 to approximately $20 billion by 2024, at a CAGR of 1.5 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this growth, which will occur across the ten major markets of the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India, will primarily be driven by the continued uptake of premium products and an increase in treatment rates as a result of the availability of novel alternatives.

Thomas Parker, Analyst, GlobalData’s Analyst covering neurology and ophthalmology

says, “The continued uptake of oral Disease Modifying Therapies (DMTs) that typically have a higher annual

cost of therapy and improved compliance rates, coupled with an increase of DMT treatment options that target

progressive multiple sclerosis subtypes, will drive growth over the forecast period. However, the market is expected to plateau between 2018 and 2020, as the generic erosion of key branded products, such as Teva’s Copaxone and Novartis’ Gilenya, offsets the uptake of pipeline agents.”

Despite this, the analyst notes that steady growth will resume from 2020 onwards, as additional pipeline products become available in Western countries.

GlobalData’s report identifies eight late-stage drug products that are anticipated to enter the multiple sclerosis therapeutics market during the forecast period, with Roche/Genentech’s ocre-

lizumab, Celgene’s ozanimod, and AbbVie/Biogen’s Zinbryta expected to generate the highest revenues.

Parker explains, “These efficacious pipeline products are expected to have a significant impact on the market, as they are likely to be popular with patients thanks to being oral formulations or requiring a less frequent dosage schedule. Collectively, GlobalData forecasts that the eight latestage pipeline products will claim a 29.8 per cent share of the global multiple sclerosis treatment market by 2024, generating combined sales of nearly $6 billion,” the analyst concludes.

EP News Bureau-Mumbai

HIV therapeutics market will crawl to $15.3 bn by 2023 The treatment landscape is expected to experience a paradigm shift towards integrase inhibitor drugs and single-tablet regimens THE VALUE of the Human Immunodeficiency Virus (HIV) treatment market will increase marginally from just over $14 billion in 2013 to approach $15.3 billion by 2023, representing a low CAGR of 0.9 per cent across the nine major markets of the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, and China, says research and consulting firm GlobalData.

The company’s latest report states that while the overall market size will not undergo major changes, the treatment land-

24 EXPRESS PHARMA November 16-30, 2015

scape is expected to experience a paradigm shift towards integrase inhibitor drugs and singletablet regimens (STRs). This shift will be most pronounced in the US, as financial austerity measures remain a primary barrier to growth in the other countries.

Moritz Herrmann, Analyst, GlobalData covering infectious diseases, says, “The market growth will mainly be driven by the introduction of novel drugs, such as STRs with improved tolerability, a reduced pill burden

or increased efficacy, and an increasing number of people living with HIV who are treated with antiretroviral therapy (ART).

However, due to patient and physician awareness of HIV often being limited, there have been low diagnosis rates, increased disease transmission, and delayed ART administration.”

During the forecast period, market growth will be limited by patent expirations of several key products, such Gilead Sciences’ Atripla

(efavirenz/emtricitabine/tenofovir disoproxil fumarate [TDF]).

Furthermore, several countries, such as Germany, China and Brazil, will promote the use of more affordable generic drugs over branded products.

However, GlobalData’s report notes that the launches of several STRs, such as ViiV’s Triumeq (dolutegravir/abacavir/ lamivudine) and Gilead’s Quad 2 (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [TAF]), will help to offset the im-

pact of generics over the next few years.

Herrmann continues, “Despite these new drugs, the HIV treatment space is still plagued by a range of environmental barriers, such as low patient awareness of the disease, and the social stigma that is associated with it in most countries. Lack of access to medicines and the high cost of therapy still represent major hurdles that must be overcome in order to fully address the global HIV epidemic.”

EP News Bureau-Mumbai

New blockbuster drugs will push multiple myeloma treatment market to $22.4 bn by 2023 The increase will be boosted by increasing therapeutic options, including the introduction of two monoclonal antibodies with blockbuster potential THE GLOBAL treatment market for multiple myeloma will rise in value from $8.9 billion in 2014 to an estimated $22.4 billion by 2023, representing an impressive Compound Annual Growth Rate (CAGR) of 11.2 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this increase, which will occur across the eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and urban China, will be boosted by increasing therapeu-

tic options, including the introduction of two monoclonal antibodies (mAbs) with blockbuster potential, namely Empliciti and daratumumab, during the forecast period.

Dan Roberts, Senior Analyst, GlobalData covering oncology and haematology, says the patent expiries of a number of key treatments will pave the way for the new mAbs to have a major impact on the multiple myeloma therapeutics space by 2023.

Roberts comments, “The

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patents of the two best-selling drugs in multiple myeloma treatment, namely Revlimid (lenalidomide) and Velcade (bortezomib), will both expire in the US and five European countries during the forecast period.

“As a consequence, Celgene will lose its dominance in this therapy area, with its market share anticipated to fall dramatically from 68 per cent in 2014 to a mere 17 per cent by 2023.”

The analyst adds that Janssen/Genmab and BristolMyers Squibb/AbbVie both

have very promising pipelines for multiple myeloma, driven primarily by the excitement surrounding their mAbs daratumumab and Empliciti, respectively.

Roberts continues, “Based on GlobalData’s primary research, it is expected that these agents will prove very popular in the stem cell transplantation-ineligible induction setting, and in patients who have relapsed on several prior therapies. We believe that Empliciti will be preferred for use in combination with

Revlimid/dexamethasone over daratumumab/Revlimid/dexamethasone, due to Empliciti and Revlimid’s synergistic actions on the immune system and Empliciti being approved first with this combination, while daratumumab will be approved first as a monotherapy in patients who have stopped responding to Velcade and an IMiD.” Both Empliciti and daratumumab are expected to first launch in 2016.

EP News Bureau-Mumbai

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RESEARCH I N T E R V I E W

‘Our TUXEDO study clearly suggests that the new generation everolimus stents are best in terms of efficacy and safety’ Prof Dr Upendra Kaul, Executive, Dean and Executive Director, Cardiology and Academics and Research, Fortis Escorts Heart Institute and Fortis Flt Lt Rajan Dhall Hospital recently presented results of a randomised clinical trial executed across 46 centres in India, by Fortis Escorts Heart Institute (FEHI) at the Trans-catheter Cardiovascular Therapeutics (TCT). In an tête-à-tête with Raelene Kambli, Dr Kaul explains the highlights of the study and also talks about its benefits for India

There are mixed views on advising diabetic patients for stent implants. What is your opinion on the same?

Patients with multi-vessel disease with diabetes needing revascularisation (stenting vs CABG) has been a debatable issue. The data suggested that CABG has advantages in terms of long term benefits, including survival. The choice of procedure needs to be looked from several angles, which include: the type of disease including size of the arteries, patient's preference and financial status, and choice of stent which is critical. Our TUXEDO study clearly suggests that the new generation everolimus stents are the best in terms of efficacy and safety.

What are the highlights of the ramdomised Indian clinical trial that you

26 EXPRESS PHARMA November 16-30, 2015

conducted?

Firstly, it is the largest study ever done, comparing one strength to another in diabetic patients. Secondly, the study which was initiated in 2010 started its execution in June 2011 and completed its one year follow up of 1830 in March 2015 and the analysis of the study was done after this study and the data of this study was presented as a 'late breaking trial' at the prestigious Trans-catheter Cardiovascular Therapeutics (TCT). The study was comparing paclitaxel eluting stents (TAXUS Element) v/s everolimus eluting stents (XIENCE PRIME) which indicated that one stent had better result in patient with diabetes.

What is the motive behind this study and clinical trial?

To resolve a decade old

controversy regarding the results of paclitaxel vs everolimus eluting stents .

There was a lingering debate on this subject with a large meta analysis from retrospective analysis showing that the two were equivalent with paclitaxel eluting stents having an advantage in insulin requiring diabetics. We conducted a 1830-patient study over 46 centres across India, the largest study so far in diabetic patients comparing stent vs stent to answer this issue.

Why have you selected these stents for comparison?

As these are the most commonly used stents in the market.

Which are the companies that manufacture them?

Paclitaxel eluting stents are manufactured by Boston Scientific and the

everolimus eluting stents are manufactured by Abbott and Boston Scientific. It is also important to note that paclitaxel as a drug molecule was developed by Boston Scientific.

Who has funded this project?

Boston Scientific has funded this huge project.

Do they have any vested interest in this study?

They have no role in investigations in this study nor did they have any role in the execution of the study. In fact, as per our study, their paclitaxel eluting stents have proved to be inferior to the other.

What was the method used for this clinical trial?

We randomly assigned 1830 patients with diabetes mellitus and

vessel failure, 5.6 per cent vs. 2.9 per cent; risk difference, 2.7 percentage points [95 per cent confidence interval {CI}, 0.8 to 4.5]; relative risk, 1.89 [95 per cent CI, 1.20 to 2.99]; P = 0.38 for noninferiority). There was a significantly higher one-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P = 0.005), spontaneous myocardial infarction (3.2 per cent vs. 1.2 per cent, P = 0.004), stent thrombosis (2.1 per cent vs. 0.4 per cent, P = 0.002), target-vessel revascularisation (3.4 per cent vs.

1.2 per cent, P = 0.002), and targetlesion revascularisation (3.4 per cent vs. 1.2 per cent, P = 0.002).

Which means that in patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not

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The TUXEDO study is the largest study ever done, comparing one strength to another in diabetic patients. Secondly, the study which was initiated in 2010 started its execution in June 2011 and completed its one year follow up of 1830 in March 2015 coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a non-inferiority trial design with a noninferiority margin of four percentage points for the upper boundary of the 95 per cent confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularisation at the one-year follow-up.

What are the results of the trial?

At one year, paclitaxel-eluting stents did not meet the criterion for non-inferiority to everolimuseluting stents with respect to the primary end point (rate of target

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shown to be non-inferior to everolimus-eluting stents, and they resulted in higher rates of targetvessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularisation at one year.

What are your learnings from this study?

This study has given India the leverage of being a trusted source for conducting clinical trials and research. Also, that this study has been recognised by the TCT is a big honour. Another feather to our crown is that this study is going to be published in the New England Journal. I would finally say that this study has paved a path for more trusted clinical trials in India. raelene.kambli@expressindia.com

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RESEARCH I N T E R V I E W

‘I wish more pharma companies come forward to support our research Dr Yogesh S Shouche, Scientist G, National Centre for Cell Science (NCCS) and Principle Investigator,Microbial Culture Collection, Pune, was a part of the team that discovered gut bacteria Clostridium punens. In an interaction with Sachin Jagdale, he gives more information about the importance of this bacteria

Was the discovery of Clostridium punens accidental or pre-planned?

We had been looking at microbes in the human gut for the last several years and expecting to see a lot of novel organisms as this is an unexplored niche. So that way, this was not a totally unexpected finding. But when you isolate hundreds of organisms, you don’t know which one is going to be a novel. It is a chance and art to discover a novel organism.

Since when are you working on it? Who are the other scientists involved in this discovery?

We are working on this for almost a decade now and this is a team work involving many scientist and students.

For example, Dr Sanjay Juvekar of KEM Research Center at Vadu helped us in indentifying human volunteers, Dr Dilip Ranande, Ex Director, ARI and Dr Om Prakash, MCC helped in the isolation of anaerobic organisms. Dr Dhiraj Dhotre of MCC is our bioinformatics expert.

Several students like Vikram Lanjekar, Nachiket Marathe, Shreyas Kumbhare, Sudarshan Shetty, Somal Chodhury were part of this project. There are many others, but the ones mentioned are the major contributors.

28 EXPRESS PHARMA November 16-30, 2015

Have your work been published in any international journal?

While describing a novel bacterium, it is mandatory that this observation is published in a scientific journal dedicated for this. All our observations are published in International Journal of Systematic and Evolutionary Microbiology.

Without publishing in this journal, global scientific community does not accept your isolate as a novel organism.

What are the characteristics of this bacteria?

Our aim of doing these isolations is mainly to develop a repository of well characterised 'friendly' gut bacteria. These can in future be used for replenishing the gut microbiota of humans if it is disturbed by environmental factors like consumption of antibiotics, drugs or even wrong diet. So, we look for characteristics like help in digestion, production of vitamins, ability to compete and win over disease causing organisms etc.

How is Clostridium punens different from other bacteria?

Our gut harbours 10,000 different types of bacteria and they differ from each

other in many ways, their metabolism, production of some compounds that regulate human metabolism etc. All this information can be inferred from the sequence of their DNA and thus their DNA is different from each other.

Our aim of doing these isolations is to develop a repository of well characterised ‘friendly’ gut bacteria. These can in future be used for replenishing the gut microbiota of humans

Does this discovery have any significance related to treatment of any particular disease?

We have so far reported only a few novel bacteria from human gut and it carries few thousand species. Many of them are bound to have beneficial effect on the treatment of diseases like obesity, diabetes and mental illness. While experimenting with animal, scientists have shown the beneficial effect of some bacteria in psychological disorders.

Which other places have this bacteria been discovered?

In India at least, ours is the only laboratory so far that has undertaken such exercise. There are few labs abroad involved in this type of work. In fact in the US and Europe, there are mega projects undertaken for the characterisation of microbiome.

Have you received any international offer for tieups for further research?

Yes, some laboratories in Spain, Germany and the US have shown interest in developing a collaboration with us. There were also some offers from MNCs to develop this research into product. But, we need to consider national interest before going ahead with these offers. Our natural resource belongs to us and the Indian population should get benefits from it.

How are you going to raise funds for your further research? Have you approached any pharma/biotech company for the same?

All the research has been funded by the government, unfortunately, the trend of industries funding basic research considering longterm benefits had never caught up in India. They fund only specific short-term projects for product development. If we had funding from a major pharma company, we could have done much more and would have been at par with our western colleagues.

So far, we have only one project on diabetes that is funded by Unilever. I wish more pharma companies should come forward to support such cutting-edge research. sachin.jagdale@expressindia.com

RESEARCH UPDATE

FDAapproves GSK’s drug Nucala for severe asthma The drug is a monoclonal antibody that inhibits interleukin-5, which helps regulate eosinophils GLAXOSMITHKLINE won US regulatory approval for its drug Nucala to treat severe asthma, the Food and Drug Administration said. The drug, Nucala, known also as mepolizumab, was approved for use in combination with other therapies for patients 12 and older who have a history of severe asthma attacks.

“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” Dr Badrul Chowdhury, Director of the FDA’s pulmonary, allergy and rheumatology products division, said in a statement. Analysts on average expect the drug to generate annual sales of

$756 million by 2020.

Nucala is administered once every four weeks by injection. The drug is a monoclonal antibody that inhibits interleukin-5, which helps regulate eosinophils, a type of white blood cell that contributes to asthma. The over-production of eosinophils can cause inflammation in the lungs, increasing the frequency of asthma attacks. Patients must also take other medications, including high-dose inhaled corticosteroids and at least one additional asthma drug. About 26 million people in the US suffer from asthma, GSK said, and up to 10 per cent suffer from severe asthma.

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Reuters

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RESEARCH

‘Designer’immune cells clear baby’s leukaemia Some scientists have questioned Cellectis' approach because of potential problems with patients rejecting foreign cells A BABY whom doctors thought almost certain to die has been cleared of a previously incurable leukaemia in the first human use of an 'off-the-shelf' cell therapy from Cellectis that creates designer immune cells. Oneyear-old Layla had run out of all other treatment options when doctors at Britain's Great Ormond Street Hospital (GOSH) gave her the highly experimental, genetically edited cells in a tiny one-milliliter intravenous infusion.

Two months later, she was cancer-free and she is now home from hospital, the doctors said at a briefing about her case in London. “Her leukaemia was so aggressive that such a response is almost a miracle,” said Paul Veys, a professor and Director of bone marrow transplant, GOSH who led the team treating Layla. “As this was the first time that the treatment had been used, we didn't know if or when it would work, so we were over the moon when it did.”

The gene-edited cell treat-

ment was prepared by scientists at GOSH and University College London (UCL) together with the French biotech firm Cellectis, which is now funding full clinical trials of the therapy due to start next year. It is designed to work by adding new genes to healthy donated immune cells known as T-cells, which arm them against leukemia.

Using a gene-editing technology called TALEN, which acts as ‘molecular scissors,’ specific genes are then cut to make the T-cells behave in two specific ways. Firstly, they are rendered invisible to a powerful leukaemia drug that would usually kill them and secondly they are reprogrammed to only target and fight against leukaemia cells. Other drugmakers including Novartis, Juno Therapeutics and Kite Pharma have tested genetically modified T-cells extracted from an individual patient. However, this is the first time cells from a healthy donor have been used in a process could lead to a ready off-the-

shelf supply for use in multiple patients.

Some scientists have questioned Cellectis’ approach because of potential problems with patients rejecting foreign cells. But the French biotech, working with the US giant Pfizer, as well as Novartis be-

lieves its method is faster and cheaper than creating single patient-specific gene therapies.

Results from Layla's case were due to be presented at the American Society of Haematology’s annual meeting in Orlando.

“This is a landmark in the

use of new gene engineering technology and the effects for this child have been staggering," said Waseem Qasim, a professor of Cell and Gene Therapy at UCL and immunologist at GOSH who worked on her medical team.

If the success in this case is sustained and replicated in other patients, he said, the therapy "could represent a huge step forward in treating leukaemia and other cancers."

Matt Kaiser, head of research at the leukaemia and lymphoma charity Bloodwise, said that while the concept of editing immune cells to recognise and hunt out leukaemia cells is ‘very exciting,’ patients and their families should note that the technique is still in the very early stages of development. “We need to establish whether it can offer a long-term cure, whether there are any side effects and which patients are most likely to benefit from it,” he said.

Reuters

Roche team develops armed antibody in antibiotic fight Scientists may look again at past antibiotic drug candidates that were deemed too toxic to use RESEARCHERS at Roche have developed a new weapon to fight hard-to-treat bacteria by arming an antibody with an antibiotic to reach and kill bugs hidden inside cells.

The approach is similar to an existing technique used by scientists at the Swiss group's biotech unit Genentech, which arms antibodies with a chemotherapy drug to tackle cancer. That system led to the development of the breast cancer drug Kadcyla. In a paper in the journal Nature, the Genentech team reported their new antibody-antibiotic conjugate (AAC) killed Staphylococcus aureus in mice that standard po-

30 EXPRESS PHARMA November 16-30, 2015

tent antibiotics failed to destroy.

Drug-resistant strains of S aureus, or MRSA, are an increasing concern in hospitals, where they can be deadly to vulnerable patients. The new AAC is designed to be inactive until it enters a cell, when enzyme activity releases the antibiotic. In an accompanying Nature commentary, Wolf-Dietrich Hardt at Zurich's Institute of Microbiology said it remains to be seen whether the AACs would be as good at treating bacterial infections in humans as in mice. But the approach is seen as promising, since it should cut the emergence of

antibiotic resistance by reducing exposure of other bacteria to active drug, while also limiting damage to the body's beneficial microbes.

In addition, it may allow scientists to look again at past antibiotic drug candidates that were deemed too toxic to use but which might be tolerated if loaded onto a highly targeted antibody "missile".

Swiss drugmaker Roche, which last launched an antibiotic in 1982, has recently stepped up investment in the field, amid growing public concern about the emergence of drug-resistant superbugs.

Reuters

PHARMA TECHNOLOGY REVIEW INSIGHT

Automation in the downstream: Chromatography column packing David Johnson, Global Product Manager, Chromatography Hardware and Systems, Pall Life Sciences, speaks on the need for automated packing systems to improve column chromatography A CONSISTENT and longlasting packed bed is crucial when using a chromatography column for purifying biopharmaceutical products. An improperly packed column can lead to ineffective separation, time-consuming repacks and, ultimately, to products that fail to meet specifications. It can also increase costs, not least because some of the solidphase media, when packed with wasteful methodologies, can result in large unnecessary expense.

Using traditional packing methods takes experience and practice. Until the recent advent of fully automated packing systems, the process was largely manual, and operatordriven packing still predominates today. Yet the single biggest cause of packing failure remains operator error. In fact, most pharma manufacturing operators highlight packing as one of the biggest risks in their downstream processing. Ideally, they would remove chromatography entirely from the manufacturing train and replace it with something easier to predict and control, but this is rarely possible given the effectiveness of column chromatography when in process.

Historically, a group of four or five operators work together to pack a column, in a routine that is closely choreographed by a SOP or batch record. This lays down detailed instructions for how the column should be packed. A suspension of particles of the

day, or even choose to move to a job at another company, reliance on key operators means the packing will have to be led by a less experienced operator or cannot be done at all.

Even if a detailed paper SOP is followed to the letter, transferring the process to another plant can be fraught with difficulties. It has been shown that the way the same SOP is executed by teams of people in separate locations often differs. Maintaining consistency is a real issue, teams may execute the SOP down to the last full stop, but it is almost inevitable that some-

separation medium is transferred from a slurry tank into the column, where it must be evenly distributed and then compressed to achieve optimal performance.

At the heart of the difficulties is the ability to execute the

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SOP’s list of instructions in a reliable and reproducible way.

All the team operators must be absolutely certain of what they are doing, and do everything both correctly and at exactly the right time. This is not as simple as it sounds and the chance of a mistake being made is high.

A knock-on risk to the business is that operators have to become very skilled to achieve the desired outcomes. If they are not available on any given

thing will be changed or omitted, however minor, because a paper SOP cannot be perfectly interpreted. Full automation of the unit operation presents the opportunity to remove most, if not all, of this risk, because automation involves machines. A machine will do exactly the same thing every time, which is a real advantage in achieving consistency when transferring technology.

Many SOPs are designed to

DAVID JOHNSON, Global Product Manager, Chromatography Hardware and Systems, Pall Life Sciences

leave an excess of the slurried medium in the tank after column packing. This is usually done to avoid breaking the prime inside the column and introducing air. Removing air bubbles not only adds an additional layer of difficulty, but Protein A media, for example, one of the most common solid phases in protein purification, can cost $15,000 a litre. 50 litres remaining in the tank after packing is a significant amount of extremely costly waste. The latest generation of automation and column geometry allows the column to be packed without the requirement of an excess, leaving empty tanks and pipework.

If a packing procedure fails, then the manual method requires the medium to be removed from the column and put back into a slurry tank before it is repacked. Not only does this take time, it increases buffer use and adds to hardware cleaning demands.

Carefully designed automation ought to be able to repack the column without the need for removing the column’s contents, saving both time and costs associated with consumables.

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PHARMA TECHNOLOGY REVIEW System automation Full automation greatly reduces the opportunity for problems to occur. The ideal automation would implement 'one touch' operation for packing, unpacking and the cleaning in place of the empty column, making the involvement of the operator minimal. Further benefits would include lower maintenance and cleaning costs, and smaller cleanroom and storage footprints.

Properly implemented, no additional pumps or packing skids should be required.

In order to automate column packing, an actuated column is required, with a piston that can be moved up and down, and additional process valving that can be controlled remotely. The automated system must be able to control both the piston’s movement and the valving. Additional sensors are required to detect parameters such as liquid levels and pressures, which enables the pack to be monitored in real time. This is essential to achieve optimum conditions, as it allows the behaviour of the machine to be altered in response to the outputs of the sensors. The sensors also act as signals that individual parts of the packing process have been completed.

The operation of a fully automated system should be simple. Once the operator presses the 'start' button for packing, it will agitate the tank, prime the filler and then suction-transfer the slurry into the column. The system then packs the optimal bed and informs the operator that the process is complete.

The software driving the process should include multiple fully parameterised method templates, with a highly adaptable configuration. The interface should be easy to use, and suitable for a general operator rather than a highly trained specialist. The method templates must be robust and must have been validated by the equipment manufacturer or the user’s engineering team, and be configurable to the precise requirements of the process run.

It is a bit analogous to baking a cake, small adjustments can

32 EXPRESS PHARMA November 16-30, 2015

be made to create a chocolate cake instead of a lemon cake, but the actual baking process essentially remains the same.

Using method templates is much more straightforward than validating a paper SOP, and once they are set, the operator is only able to execute the recipes, not alter them.

Process chromatography columns are essentially pressure vessels, and as columns get larger, the forces required to contain the pressure during packing and operation get exponentially greater. Including more than one actuator for piston control is an advantage in terms of gaining the ability to contain these forces, particularly when columns can be as wide as 2m. Three separate actuators, spaced out around the piston, allow the precise levels of the piston to be monitored and controlled. The result is a decrease in the likelihood of damage being caused to the column during the packing process.

Should packing fail for any reason, an automatic repacking process allows it to be fixed without emptying the medium into a separate slurry tank, rendering a faster turnaround with no tank cleaning or other equipment required.

The buffer consumption for repacking is very low; for example, around 150 litres of buffer are required for a 1400 mm ID packed bed with a 190-

litre bed volume.

Ideally, the system will be designed such that the only time the media is removed from the column is when it has reached the end of its life, or is no longer required for that particular process.

When the media needs to be removed from the column, it should be unpacked using as little liquid as possible. An automated process facilitates predictable usage of unpacking liquid and efficient use of buffers, resulting in equivalent or fewer slurry volumes to manual unpacking by an experienced operator. Importantly, almost all the sorbent is recovered. In equipment terms, no pump is required and lower media shear is created.

When the operator presses the start button for the unpack, the system initiates the suction of the unpacking liquid, and the medium is then re-suspended before the slurry is pushed back to the tank. Then, another aliquot of unpacking liquid is suctioned, allowing the remaining media to be re-suspended and pushed back to the tank in slurry format. An optional further rinse can follow, if necessary.

Further ease of use can be delivered via an automated clean-in-place (CIP) process.

First, the CIP liquid is suctioned into the column. The pipework and valves are tur-

bulent-flow-cleaned, and the CIP liquid is then held at full bed height before the column is emptied. Once the operator changes the tanks, a mandatory manual step between two fully automated sequences, neutralising liquid is sucked into the system and the column is rinsed. Again, there is the option of adding an additional rinse.

Not only does it clean the empty column, all pipework and valve weirs are cleaned independently. There is a single exit for waste flows, facilitating the monitoring of pH or conductivity. All velocities and hold times are configurable to ensure optimised liquid consumption. And, again, no pump is required, saving on equipment costs.

With the modern trend toward single-use equipment to reduce cleaning costs and minimise the risk of carryover, it is possible to include at least some disposable technology within the automated column packing process. It is still early days, but by using an integrated pinch-valve block that can be transferred between columns, fully automated operation is possible using a disposable manifold in conjunction with single-use buffer biocontainers. A mixing tote can also be incorporated, to provide a fully disposable slurry handling train. This removes much of the need for cleaning, and incorporates minimal servicing requirements.

Case studies As an example, the driving force behind automatically emptying a slurry tank is to reduce operating expenses resulting from the cost of the separation medium. By modelling a customer’s process information, it was possible to design a system that would save them money. Given its normal operator procedures and the number of times a year a column was packed, we showed that the automated system would be significantly cheaper to run, even given the equipment and implementation costs.

The biggest reduction in expenditure comes in reduced

media costs. Savings of $1.3 million a year might be expected for a typical 2000 mm Protein A capture step compared with existing technologies. The savings rise to an annual $1.9 million over a three-column train. A further advantage is the reduction in the documentation required to address sorbent carryover. It is the ability to empty the slurry tank—something that it is not practical to do when packing manually—that leads to these substantial cost savings.

In a second example, the customer was concerned about the potential for operator error in a vaccine separation process. The frequency of column repacks was very high, and the customer wanted to reduce errors, with knock-on reductions in packing labour costs and sorbent consumption. Upon implementation of automated packing, the labour costs were modelled at 40 per cent and, importantly, the packing success rate was forecast to rise from 62 per cent for a manual pack to an anticipated 99 per cent for automated packing.

Finally, in a third example, retrofitting automated packing technology into an existing column set up also saved money. The original highly engineered packing system was being used to purify a biosimilar product. With the investment having already been made in columns, the customer did not want to start again, but it was possible to retrofit an automated system into the columns so that capital cost was not wasted.

In summary, manually intensive column packing remains a productivity bottleneck, and a significant pressure point where errors are made. With the ability to fully automate sorbent handling and column packing, as well as unpacking and CIP of the empty column, this bottleneck can be relieved. The ability to get expert levels of packing repeatedly without the need for specialised personnel eases staffing challenges, facilitates technology transfer and, importantly, maximises usage of the expensive medium.

PHARMA ALLY I N T E R V I E W

‘Single-use system improves sterility’ Pavan Urs M, Regional Sales Manager, India, Colder Products Company (CPC), talks about the necessity of single-use system for the Indian bio-pharmaceutical industry, in a discussion with Sachin Jagdale

What are the advantages of single-use systems and how are they relevant to India’s bio-pharmaceutical industry?

One of the key advantages of single-use systems is their ability to increase speed to market while enhancing cost efficiency. Traditionally, biotechnology research centres spend significant time and cost in building and retrofitting their manufacturing facilities.

Upon completion of the research, time and cost is further spent in the planning, redesigning and scaling up of their production processes.

Single-use systems hold the potential to overcome these challenges as plants designed around them are typically less complex. Faster set up, reduced capital requirements for new builds and smaller facilities footprints are made possible, allowing bioprocessing companies to devote their resources to researching and developing more profitable products. Notably, the use of single-use systems in the production stage also means that cross contamination risks and cleaning requirements are all reduced.

As India’s bio-pharma industry advances rapidly, higher standards are being expected from the region and Indian firms are challenged with having to keep up with international standards and regulations while keeping their costs low. Single use systems allow manufacturers to benefit from improved sterility assurance, quality

control and shorter validation cycles that are critical to remaining competitive in the biopharma industry.

What are the characteristics of quality single-use systems?

In general, users can evaluate the quality of singleuse systems from three aspects. The first consideration is the safety and durability of the technology. Many global pharma companies recognise the importance of this and only choose to work with industry-accredited partners such as those with the ISO 9001:2008 certifications. It is also common for them to conduct comprehensive testing, ensuring the safety and durability of the technology before purchase.

Secondly, users need to consider if the singleuse system of their choice is designed to meet the goals they wish to achieve in their bioprocess. The third consideration is ease-of-use.

Intuitive, userfriendly designs can significantly reduce the risks of manual operation errors that in turn can threaten the safety of the user and quality of the final product.

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Single use systems allow manufacturers to benefit from improved sterility assurance

Could you give an example of how a single-use system is used in pharma R&D? Closed single-use systems used in research (R&D) and process development (PD) cell culture applications is an apt example. Such systems reduce the risk of two critical forms of contamination: biological contamination and cross-contamination.

Biological contamination includes competitive organisms such as bacteria, fungi and yeasts that are inadvertently introduced into cell culture processes.

These organisms utilise culture nutrients, produce unwanted proteins and limit growth or destroy the intended cell culture. Most biological contaminations result in rapid growth and observable culture changes that indicate a culture must be discarded. However, slow growing contaminations can be subtle and may only become apparent when unwanted proteins are detected. In either case, biological contaminations are costly due to wasted time and materials. Crosscontamination results from protein residues from cell culture and processing equipment that is reused without proper cleaning or that may migrate between two

different processes that utilise open systems. These residual proteins might inhibit proper cell growth or, if they are structurally and chemically similar to the target protein, they pass through purification with the target protein and yield inconsistent results. For R&D and PD applications, closed, single-use systems can protect against both biological and crosscontamination, saving valuable research time and money.

Flexibility is critical in pharma R&D. Can sterile connectors offer such flexibility? What are some innovative connectors that bio-pharma professionals should be aware of?

Sterile connectors with appropriate features can provide the necessary flexibility. For instance, bioprocess engineers who may want to combine sterile connect and disconnect functionality all in one connector, eliminating the need for a custom assembly with tubing, can consider integrated combination connectors. An example of this type of connector is CPC’s AseptiQuik DC. With this connector, a sterile connection can be established in a simple, three-step process that allows sterile liquid transfer in a few seconds. After liquid transfer, an aseptic disconnect can be made in a single step that takes just another second or two to complete.

Similarly, a connector that

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PHARMA ALLY combines sterile connect and SIP (steam-in-place) capability is also an integrated combination connector. Such connectors are typically needed in biopharma processes using a hybrid combination of stainless equipment and single-use systems. Using CPC’s AseptiQuik STC as an example, a 3/4-inch mini sanitary junction is used to integrate a sterile connector directly with a SIP connector. This provides the user the flexibility to SIP the combination connector to the stainless equipment in advance and then utilise the AseptiQuik sterile connector to quickly connect any number of different manifolds or bags systems when it is time for product transfer without the need to wait 30-60 minutes to perform the SIP cycle. The sanitary junction provides a more secure connection and reduces the number of potential leak points associated with use of a length of tubing between the connectors.

As the leading innovator of connection solutions, CPC has been at the forefront of technical innovation. How will single-use systems continue to

Many of our customers in India are vaccine manufacturers. In general, CPC’s products have helped our customers in India make the transition from stainless steel to disposables advance/develop?

With regards to the use of single-use technologies, two of the biggest trends we see in the industry are the transition toward more closed systems and the drive toward modular system design. Sterility assurance is a major factor in the adoption of closed systems, as the leading provider of connectors we see an associated conversion toward sterile connectors.

This trend is often tied with manufactures moving to greater utilisation of modular system design as they work to reduce the number of different custom assemblies they purchase – thus driving greater volume into a limited number of modular sub-assemblies that can be assembled together to create a wide range of flexible plastic based process solutions. Such sub-

assemblies designs are further simplified by incorporating genderless connectors that minimise the required number of configurations create greater harmonisation and streamline supply chain requirements.

The short-term future for single-use technologies include: continued adoption, the push toward standardisation of industry requirements (an example would be extractables testing harmonisation), the adoption of modular system designs and continued innovation within component technology and system offerings to address both upstream and downstream requirements.

India are vaccine manufacturers. In general, CPC’s products have helped our customers in India make the transition from stainless steel to disposables. For instance, instead of stainless steel fittings, customers make use of CPC’s MPC quick disconnect couplings in conjunction with laminar flow hoods for quick, easy and secure connections.

Additionally, CPC’s SteamIn-Place (SIP) connectors have replaced the traditional manual T valves to simplify hybrid system integration, while its aseptic connectors allowing sterile transfer and disconnect in an open environment minimising risks while replacing the industrial grade QRC.

How have some of your clients in India made use of CPC’s products?

Many of our customers in

India is a cost-sensitive market. How are you going to keep your services valuable to Indian bio-

pharma companies?

At CPC, we believe that innovating and developing new technology is driven by both suppliers as well as users. We recognise that drug manufacturers in India are constantly looking for solutions that enable them to cost effectively develop and introduce new therapies on a global basis. As suppliers, we are constantly working with our customers to identify and address these needs with new connection solutions that improve the overall functionality and design of their existing equipment and processes. We focus on bringing true value, such as quality, reliability, flexibility and efficiency that are required to stay ahead of competition.

CPC innovates on the leading edge of what is possible and collaborates to develop the best solution for each customer. Many of CPC’s standard couplings and fittings began as custom engineered solutions that found broader use in applicable markets. To date, CPC has produced over 10,500 custom and standard products to meet the fluid handling challenges of various industries worldwide. sachin.jagdale@expressindia.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

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

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

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

34 EXPRESS PHARMA November 16-30, 2015

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

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

PHARMA ALLY VENDOR NEWS

Shimadzu & Toshvin celebrate 45 years of partnership Series of customer appreciation events were held in Mumbai, Delhi, Bangalore and Vadodara SHIMADZU CORPORATION, Japan and Toshvin Analytical recently celebrated the 45th anniversary of their partnership in India with a series of customer appreciation events in Mumbai, Delhi, Bengaluru and Vadodara.

Hiroo Fukushima, General Manager, International Business Department, Shimadzu Corporation, Japan was the Chief Guest and Kiminobu Imura, Managing Director, Shimadzu Asia Pacific, Singapore and Yoshiyuki Fujino, Managing Director, Shimadzu Analytical India were also present for the occasion.

Started in 1970, the partnership between Toshvin and Shimadzu has been successful in establishing Shimadzu as one of the leading analytical instruments brands in India with a dominant market share for UV

& FTIR spectrophotometers and GC and GCMS systems.

Toshvin, closely supported

by Shimadzu India’s Customer Support Centre for application support, is exclusively responsible for marketing and servicing a range of Shimadzu’s analytical instruments. Currently, Toshvin supports an installed base of

over 12,000 Shimadzu instruments and has more than 7,500 customers across the country.

Fukushima stated, “This year marks yet another milestone with Toshvin, our oldest marketing partner in India. We enjoy a unique and close collaboration that has helped us effectively support our customers in

India. Along with our other marketing partners, Shimadzu has become one of the leading brands in the market. India is an important market for Shimadzu and we remain committed to working closely with Toshvin and our other partners to support our customers here.”

Nakul Toshniwal, Managing Director, Toshvin Analytical said, “Thanks to the support of our esteemed customers, we have reached this unique milestone in our partnership with Shimadzu. We are committed to supporting and closely partnering with our customers as they take India to greater heights in the areas of pharmaceuticals, chemicals, food, testing services, scientific research and academia.”

The events also marked the pre-launch of Shimadzu’s new

GCMS QP 2020 which will be officially launched worldwide at the end of November 2015. This new GCMS continues Shimadzu’s long tradition of launching products with leading edge technology and top of the line specifications.

Manoj Kantak, Executive Director, Toshvin Analytical stated, “We are excited about the up-coming launch of the new GCMS QP 2020 from Shimadzu, which brings the latest technology to our customers in India.

The capabilities and versatility of this new GCMS will increase the range of applications for which our customers can use the system. ” The new GCMS will be available to customers from December this year.

EP News Bureau-Mumbai

Ashland presents science-based strategy to enhance pharma formulation quality Polymer excipients will better serve the pharma industry in its effort to develop robust, safe, and efficacious products to deliver drugs and increase bioavailability DURING THE recent American Association of Pharmaceutical Scientists (AAPS) annual meeting and exposition in Orlando, Florida, Ashland had both posters and presentations that supported its new campaign, “Advancing Drug Delivery with Superior Polymer Chemistry” that promotes a scientific approach to select polymer excipients that will better serve the pharma-

36 EXPRESS PHARMA November 16-30, 2015

ceutical industry in its effort to develop robust, safe, and efficacious products to deliver drugs and increase bioavailability.

“A holistic, science-based approach to excipient selection rather than a traditional empirical approach affords the pharma industry the ability to consider the impact of polymer excipients in key areas of drug development, in-

cluding manufacturing, bioavailability and stability,” said Thomas Durig, Senior Director of pharmaceutical and nutrition specialities, research and development, Ashland Specialty Ingredients.

During a presentation entitled, “Reducing Formulation Risk with Science-based Excipient Selection,” Durig explained that rational selections of excipients require an

understanding of structurefunction and structure-property relationships of input material.

Ashland utilises structurefunction models in its development laboratories to find or develop polymer excipients that serve to improve the manufacture and end-use functionality of specific drug products.

Experts in polymer design and characterisation, Ashland

scientists have a fundamental understanding of the functional performance and physicochemical stability of both cellulosic-based and vinyl pyrrolidone-based excipient technologies. Research scientists, within Ashland’s laboratories, work to advance polymer excipient technologies to improve product performance while enhancing bioavailability.

EP News Bureau-Mumbai

PHARMA ALLY PRODUCTS

Romaco to showcase its products at P-MEC 2015 ROMACO WILL showcase its solutions for aseptic filling, tableting, granulation and coating of pharmaceutical products based on Macofar, Kilian and Innojet technologies at P-Mec 2015 in Mumbai. The exhibits on show will demonstrate Romaco’s extensive expertise when it comes to processing pharma liquids, powders and granulates. The innovative Macofar MicroMaxX 18 microdosing machine will be showcased first time in Asia since the successful world premiere at ACHEMA 2015.

process steps. Thanks to the new weight control system, all vials can now be weighed individually for the first time. The Macofar MicroMaxX 18 is the fastest in the market today with one hundred per cent weight control, with an output of 12,000 vials an hour. It can be equipped with various containment systems owing to its modular concept.

Sterile external access to all components is assured

Macofar MicroMaxX 18 The Macofar MicroMaxX 18 microdosing machine is suitable for processing both pharma powders and sterile liquids and meets all the requirements for downstream freeze-drying. The Macofar MicroMaxX 18 features a dual dosing disc which allows multiple dosing into the same vial; alternatively, the product can be filled in two separate

Romaco Macofar LVI 6

Romaco macofar micromaxx

To subscribe: bpd.subscription@expressindia.com

via glove ports.

Macofar LVI 6 The newest generation of Romaco’s Macofar LVI 6 has been specifically developed for handling sterile ophthalmic medications. This double indexing machine achieves a maximum output of 150 glass or plastic bottles per minute. The monobloc design of the aseptic rotary filler unites the three main operations, namely liquid

filling as well as the application of the dropper and screw cap.

This compact machine is moreover ideal for use with an open restricted access barrier system (RABS). A special recirculation system can be integrated in the product tank for filling suspensions. Microbiological checking, particle presence checking and nitrogen flushing before and after filling the bottles can be supplied as options. The 100 per cent torque control provides optimal process control in case of eye drops. The Macofar LVI 6 can be flexibly configured and is available with weight control on request.

Contact details Susanne Silva Market Communications Romaco Group Am Heegwald 11 76227 Karlsruhe Germany P +49 (0)721 4804 0 F +49 (0)721 4804 225 E susanne.silva@romaco.com

Multisorb Technologies launches PolySorb desiccant card MULTISORB TECHNOLOGIES has launched PolySorb desiccant card, an innovative low-profile desiccant for managing moisture in a wide variety of pharmaceutical products including packaging of invitro diagnostic device kits, transdermal pharma delivery systems, and foil pouches.

With an ultra-thin and low-profile design, PolySorb desiccant cards fit easily into any packaging, providing an ideal solution for lowlevel, humidity-related stability issues when product packaging lacks available space for a traditional desiccant packet.

With options for size and shape, the new PolySorb cards offer flexibility and ease of use. The product is dust-free and can be easily dispensed on automated packaging lines using standard friction feeders. Available in custom sizes and shapes, the cards can be produced to meet specific user requirements and are fully supported by a Type III Drug Master File.

Stock sizes include 0.5g and 1.0g equivalent cards.

Contact details Kay Krause Phone : +1 716.824.8900 Fax: +1 716.824.4128 E-mail: kkrause@multisorb.com Website: www.multisorb.com

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PHARMA ALLY

Gandhi Automations offers clean room high speed doors GANDHI AUTOMATIONS, automation and loading bay equipment company is offering clean room high speed doors — Prime Clean.

Clean room A clean room is an environment typically used in manufacturing and scientific research with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapours. A clean room has a less or no level of contamination.

Usage and benefits of clean room doors In the pharmaceutical industry, clean room doors play a crucial role in the manufacturing of pharma products

which require the environment to be free from microbial and particulate contamination and protected from moisture — controlled environment.

Clean room high speed doors designed and manufactured by Gandhi Automations are high in demand in industries such as pharma and chemical, which require quick open and close applications at the entry and exit points as controlled environment needs to be maintained.

These industries make high demands with respect to hygiene, sealing, operating reliability, fitting and a trouble free after-sales service. The clean room high speed doors satisfy all these requirements and work in strictly regulated

operating conditions.

Gandhi Automations offers custom-made solutions for these sectors, while investing a lot of time and money in courses and training for the company’s own production staff and technicians.

The key features of clean room high speed doors offered by Gandhi Automations are briefly mentioned below: ◗ Clean room high speed doors are designed for inside applications and protects your environment against draughts, humidity, dust and dirt ◗ Operating speed and superior sealing properties improve traffic flows and provide environmental control and savings on energy costs ◗ Concept of low air perme-

ability in pressurised rooms with positive and negative air pressure ◗ High door efficiency and low permeability values EN 12426 EN 12427 : < 12m3 / m2h ? 50 PA ◗ High leak tightness is due to curtain being tightly integrated in special SS 316 matt finish side guides ◗ Bottom safety edges and photocells combine to ensure operator safety at all times ◗ Heavy duty motor: 400V three phase, opening speed

upto 1.5 m / s with inverter system ◗ Size upto: 4000 mm (W) X 4000 mm (H) Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West) Mumbai – 400064, India.

Off: +91 22 66720200 / 66720300 (200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

Seidenader DS12+ thickness sorting machine redesigned SEIDENADER’S AUTOMATIC DS12+ thickness sorting machine has been re-designed for more user-friendly handling and lower maintenance. Additional practical design details and a touchscreen (HMI) have optimised operating comfort and make for easy maintenance in the automatic sorting of tablets.

At the heart of the re-engineered DS12+ are the inclined sorting channels, each with two counter-rotating, high-precision and robust rollers which reliably guide tablets or comparable products successively through the channel for sorting. Moving and adjustable rows of flaps above the sorting channel prevent the products from overflowing and separate any tablets which may be lying on top of one another. The precisely adjustable gap between the rollers increases along their length: in

38 EXPRESS PHARMA November 16-30, 2015

the upper section it is narrower than in the lower section. Depending on thickness, the tablets automatically drop into three different discharge channels: 'too thin' at the top, 'good' in the center and 'too thick' at the bottom end. Optionally, smaller fragments can be screened out through a perforated plate prior to the actual sorting process.

New technical details make the machine even easier to operate and contribute to reduced maintenance. It features a userfriendly control panel (HMI) with touchscreen. In the event of a product change the formulae for the product-specific machine settings can be retrieved from the HMI. Menu-guided, the dimensions for the new tablets format are set manually and reproducibly, and confirmed in the HMI. A convenient new feature is

sensor-protected setting of the gap between the rollers of the sorting channels. Adjustment wheels in the upper and lower section of the cylinders simultaneously regulate the clearance in all sorting channels. A sensor in each setting range checks the roller spacing, which is displayed in the HMI with hundredth millimeter precision.

The overall design has likewise been optimised. The ma-

chine has become more compact and lower, making it easier to load. The hopper for the feeding-in of the tablets can also be tipped backwards, facilitating cleaning and maintenance. All parts of the machine are easily accessible. If necessary, individual rollers can be quickly and cost-efficiently replaced. All components which come into contact with the product are made of FDA-compliant materials.

The DS12+ offers a high sorting capacity of up to 1,000 kg/h, depending on the size and type of product. The sorting accuracy is continuously adjustable up to ± 0.05 mm. A format change requires only the replacement of a single format part. The machine can be integrated into the production line at various different points: installing the DS12+ upstream of a blister machine prevents interruptions to the pack-

aging process caused by products that are under- or oversized. When installed prior to the coating of tablets, the DS12+ ensures that only products of the correct size and shape are coated. Following coating, tablets that are stuck together or whose coating is too thick or irregular can be ejected. The machine can also be used for separating off foreign material that can be detected on the basis of size. Seidenader will showcase its products at DS12+ in Mumbai during P-MEC 2015.

Contact details Seidenader Maschinenbau GmbH Christian Gamperl Lilienthalstr. 8, 85570 Markt Schwaben/Germany Tel. +49 8121 802-253 Fax +49 8121 802-49253 e-mail: christian.gamperl@ seidenader.de

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UNIPACK MACHINES PVT. LTD. UMP

AN IS/ISO 9001:2008 Certified Company

UNIPACK UNIPACK LAUNCHES ITS LATEST NEW PRODUCT POLYPROPYLENE PLATE & FRAME TYPE FILTER PRESS ANYTHING IN FILTRATION WE HAVE A SOLUTION

FOR LIQUID SOLID SEPARATION

FILTER PRESSES - FILTER PLATES

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MEMBRANE Filter Plates

APPLICATION OF FILTER PRESSES Dyestuffs : Dyes, Dyestuff, Pigments, Intermediates for dyes etc.

Chemicals : Basic Chemicals, Organic & Inorganic Chemicals, Phosphoric Compounds, Agro Chemicals, Pesticides and Others.

Food Industry : Food Colours, Starch & Glucose, Fruit Juice, Squashes, Edible Oil, Palm Oil, Rice Bran & Glycerine.

Mining & Metallurgy :Zinc, Copper, Nickel, Cobalt, Silver, Electroplating & Non Ferrous Metal, Mineral Concentration, Pollution:

Flotation tailings, Ceramic products and others.

Effluent Treatment, Sewage Treatment, Industrial Waste Water Recycling, Sludge Dewatering Resulting from: Pickling Plants and galvanic plants, Industrial water and Potable water treatment plants, Dust scrubbers, Industrial sludge dewatering plants, Municipal sludge dewatering plants.

Redg. Off. 8 Krishna Mahal, 2nd Floor, ‘D’ Road Churchgate, Mumbai 400 020 Tel: +91 22 2281 2918 / 2281 0408 Works: Agarwal Ind Estate, No. 6, Unit No. 2, 3, 8, 9 & 10, Sativali Road, Village Waliv, Vasai (East ), 401 208 Dist Thane, Maharashtra INDIA Telfax: +91 250 2453 967 / 2455 449/ 2453 580 Email: ump1990@gmail.com. Website: www.unipackmachines.in EXPRESS PHARMA

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SADE SP440

100% WEIGHT SORTING

C Ph Jo H I, in al P u l 5 -M s St EC a an I t d nd M ia 2

ALL TABLETS | ALL CAPSULES | ALL SIZES

WEIGHT SORTING FOR THE PHARMACEUTICAL INDUSTRY The SADE SP440 is a versatile and effective weight sorter for use in pharmaceutical production, quality control and R&D departments for the 100% weight sorting and recovery of failed batches of tablets, capsules and softgels.

SADE SP440 KEY BENEFITS

• Sorts tablets, softgels & capsules • Sorts different shapes & sizes • No change parts between product batches • Consistent & high accuracy, +/- 1mg • Quick and easy clean down • 24-hour operation • Statistical reporting

Contact us today for more information.

Email: info@ptepl.com

• Material certification & validation documentation • Installation & operator training by our experienced Customer Support Engineers

Our weight sorters are used by customers in India amongst others: AUROBINDO - DR. REDDY’S - MYLAN LABS - JOHNSON & JOHNSON PIRAMAL - RANBAXY - SANDOZ

Process Technology and Electronics Pvt. Ltd. R. O . : 5 Malkauns, N.P. | Thakkar Road | Vile-Parle (E) | Mumbai - 400 057 | India T +91-22-6505 5819 F +91-22-2613-4269 E info@ptelectronics.in www.ptepl.com

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

Microbial Detection & Identification

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

www.criverindia.com

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OSMOMETER 3250

Milk Cryoscopes Available

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AVAILABLE DIRECTLY FROM THE MANUFACTURER AT HIGHLY COMPETITIVE PRICES < Ortho / Para Anisic Acid < Ortho / Para Cyano Phenol < 2 – Ethoxy Benzoic Acid < 1 / 6 – Hydroxy – 2 – Napthoic Acid < 3 / 4 / 5 – Methyl Salicylic Acid & Ester < 3 / 4 / 5 – Chloro Salicylic Acid < 3 / 4 / 5 – Amino Salicylic Acid < 6 – Methoxy – Naphthaldehyde < All types of Paraben & Mixtures thereof.

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PHARMA LIFE

Employee Value Proposition would play a pivotal role in luring and retaining the best talent in the coming years and it is time for pharma companies to implement such measures on a priority basis

BY SANJIV DAS

58 EXPRESS PHARMA November 16-30, 2015

A

s the ‘Make in India' mission gains traction, the country is expected to witness a surge in hiring activity in the coming months across sectors. The companies would be on the look out for skilled manpower and retaining good talent would become very imperative. A top employer is an organisation that treats employees with respect, has loyal employees, is socially responsible, and has a work culture aligned with employees' values. In order to improve morale at the work place, some employers give their employees time off to volunteer and also provide funds for their philanthropic work. The pharma sector will be one of the primary drivers of hiring activity. In such a scenario, ensuring that employees are kept stimulated and satisfied is of paramount importance and slowly employee value proposition (EVP) is gaining prominence.

Explaining EVP The concept of EVP has been adopted by several pharma companies as an important means to retain the best of talent and also reward its employees for good work. So, what does this concept actually entail?

Pradip Sachdeva, Head HR, Mankind Pharma enunciates, “It is the unique set of benefits which an employee receives in return for their skills, capabilities and experience which they bring. It is about defining the essence of your company as well as the give and get between company and employee encompassing every aspect of the employment experience. It rotates around the central reasons that people are proud and motivated to

work, such as the inspiring vision and distinctive culture. When integrated into all aspects of a business, a strong EVP will help to retain top performers and attract the best talent.”

Says Milind Thatte, Director - Commercial Development, Merck, “EVP is about attracting the right talent and setting the platform for employee engagement. With consolidation in the industry and the competitive world that we work in, EVP in my opinion is very important. The demand supply gap is changing. Jobs are getting created constantly and therefore managing, engaging and retaining talent has become a challenge for every organisation. EVP addresses this very issue.”

Smita Saha, VP – HR, AstraZeneca India says that EVP is built on the principles of corporate brand, which in turn helps to drive the business and culture forward. It also helps to differentiate offerings in an increasingly competitive marketplace for talent.

Indoco Remedies, a leading pharma firm, believes that each employee is an individual first and that satisfied employees are key to success of strategies and achievement of company’s goals.

Aditi Kare Panandikar, Managing Director, Indoco Remedies explains, “We have a history of employees putting in long services and staying committed to the company. This is because the employee

feels that they belong here and relate to the culture of Indoco. We believe, good employee policies, programmes, rewards and benefits are essential to create an environment where an employee feels involved, engaged, has a high level of ownership with the organisation.”

Saha informs, “At AstraZeneca, our core EVP encapsulates and conveys those messages that define our unique promise. As an organisation, we are building a culture with values that promote scientific curiosity, that is agile and high-performing, and which attracts, develops and retains great people.” The four broad pillars of AstraZeneca's EVP, according to her are inspiring company, a thrilling experience, school of excellence and a culture of congeniality.

However, EVP needs to be well communicated across levels to get the true value. Kamal Karanth, Managing Director, Kelly Services & KellyOCG, India explains, “By the nature of the industry we are in, there are a certain set of benefits that we offer our employees through various programmes, processes and systems that we have in place. This helps employees perform better, stay motivated and also see value in being associated with the brand. These are a set of programmes that are packaged for the employees that we consider EVP. It needs to

A top employer is an organisation that treats employees with respect, has loyal employees, is socially responsible, and has a work culture aligned with employees' values

To subscribe: bpd.subscription@expressindia.com

be communicated at frequent intervals for employees to start associating with it.”

Brand building Many industry veterans feel that EVP can also help in employer branding. They believe that the day is not far when employers across sectors including pharma will concentrate on attracting talent by employer branding as well as using channels like social media and other marketing tools to reach out and tap relevant candidates.

Sachdeva says, “The employment brand, just like a consumer brand, is how the future and current workforce understand this proposition. How they feel and connect with it. And finally the reputation it creates for the organisation. The ultimate desire is of course, that the proposition is so lucrative and well enough understood that current employees are consistently reminded what a great organisation they work for, and future workforce will be fascinated by the opportunity.”

Panandikar elaborates, “Existing employees themselves create such a culture, which becomes a key driver for employer branding. A satisfied staff can spread a good word about the organisation and becomes a true ambassador of the company.”

Says Saha, “A compelling, consistent, visible and distinctive EVP acts as a key driver for talent attraction, engagement and retention – which is ultimately what an employer brand seeks to achieve.”

Embracing EVP The advantages of EVP are myriad and multifaceted, yet many pharma companies continue to be resistant to the concept. So, how is it likely to affect them in the long run?

Thatte says, “Organisation who restrain from

Organisation who restrain from adopting EVP are not aligned with the changing world Milind Thatte Director - Commercial Development, Merck

EVP is built on the principles of corporate brand, which in turn helps to drive the business and culture forward Smita Saha VP – HR, AstraZeneca India

We have a history of employees putting in long services and staying committed to the company Aditi Kare Panandikar Managing Director, Indoco Remedies

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PHARMA LIFE

When integrated into all aspects of a business, a strong EVP will help to retain top perfor mers and attract the best talent Pradip Sachdeva Head HR, Mankind Pharma

EVP is important in boosting employee morale and brings in the competitive spirit within employees Kamal Karanth Managing Director, Kelly Services & KellyOCG, India

adopting EVP are not aligned with the changing world. Today, a talented executive is sought after by many companies and therefore an organisation with right EVP can attract the talent to begin with. Else why do we see very few from the IIM cadre who join the pharma industry? I have been on the campus and found that pharma jobs are the last preferred ones. The same way, even in middle rung managers the same people keep rotating between the companies. We seldom see cross pollination with other industry.” She further opines that the growth of a company comes from its people, based on how talented they are. It is based on how they frame a strategic road map for the organisation. He adds, “So, if an organisation cannot attract capable talented leaders, how will the company grow?

Mediocrity breeds mediocrity!”

Karanth predicts, “Organisations that restrain from adopting EVP aren’t being sensitive towards engaging employees and over a period of time might lose some of their best and most critical talent. EVP is impor-

The advantages of EVP are myriad and multi-faceted, yet many pharma companies continue to be resistant to the concept.Organisations using EVP effectively are more likely to see that their employees are engaged and twice as likely to achieve their goals tant in boosting employee morale and brings in the competitive spirit within employees. ” Sachdeva, while quoting a survey report from Gallup, a global performance management consulting firm, found that only 30 per cent of people are engaged at work, while 50 per cent are just kind of present, and an alarming 20 per cent are actively disengaged or miserable. He says, “With this improved economy, why do you think so many employees are so unhappy? I believe that the answer lies in the company’s EVP, what the organi-

sation wants and expects from its employees and what it provides to the employees in return. A strategically developed and communicated value proposition conveys, 'Why the total work experience at an organisation is superior to other organisations'.”

“A lot of employee activities required to create value are at times perceived as investment in the short term by companies that restrain from adopting EVP. It is very essential to align the various practices followed by an organisation with its organisational vision, mission and

business strategy as well as study their effect on the organisation's growth. As long as the organisation has an institutional leadership, it will always opt for EVP to drive its growth through people power,” states Panandikar.

In times to come Organisations using EVP effectively are more likely to see that their employees are engaged and twice as likely to achieve their goals.

As Sachdeva affirms, “A company that remains true to its brand promise receives more favourable people’s opinion and enjoys higher levels of credibility and profitability than those organisations that default on their promises. This makes a company a preferred choice which in turn provides an edge over others. Thus, these companies are often able to achieve higher levels of profitability, efficiency, and overall success.”

Implementing EVP would become inevitable to a company's growth in the coming times and the sooner a company embarks on this path, earlier it would progress. sanjiv.das@expressindia.com

Initiatives...

KELLY SERVICES MANKIND PHARMA ~ Rewards and recognition

~ Leadership development programme

~ Talent development programme for all employees

ASTRAZENECA ~ Offer global career opportunities to employees ~ Focuses on employee reputation

and integrity and building a strong leadership pipeline

~ Strong presence of training and development programmes for employees including internal trainings on soft skills, leadership skills etc ~ There are annual pay hikes for top

performers by which the company identifies and recognise the best ~ Believes in creating an internal

talent pool to draw upon for new ideas and initiatives ~ Provides enormous prospects by

way of ‘Internal Job Posting’which helps employees achieve their career aspiration within organisation

MERCK

INDOCO REMEDIES

~ On-board programme for new employees

~ INSPIRA, a cultural programme with employee participation held every year on Chairman’s birthday on January 9.

~ A closed group FB page for employees to share good practices, success stories

~ An annual sport day event, PACE, as also Annual Dasara puja is undertaken at all locations.

~ Celebrate festivals, and group

activities at the head office on Merck day ~ Diversity and inclusion day

celebrated to encourage employees to participate and develop mutual respect. E.g. Men and women employees competing in a culinary skills

~ Many manufacturing locations have established employee credit cooperatives with 80 per cent staff participation by way of membership. ~ ASPIRE – KRA based performance evaluation and review mechanism ~ IMPETUS – A forum for professional growth for senior management team ~ RETREAT – Informal meet of higher and senior management team ~ AGAMAN – Interaction of new employees with the higher management ~ SAMPARK – Development programme for second line managers ~

~ Periodic town hall meets are

conducted to cascade the current information and update the staff of the company initiatives and financials

GEMS – A mentoring programmeto create leaders from within

~ CLIMB – A group of middle managerial team coming together for mutual benefit ~ IMPACT-Training programme within Indoco on behavioral aspects and ~ Star Awards

60 EXPRESS PHARMA November 16-30, 2015

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