Express Pharma (Vol.10, No.12) April 16-30, 2015

VOL. 10 NO. 12 PAGES 68

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Market Indoco acquires Piramal’s clinical research division Packaging Special PET vs glass: The debate continues 16-30 APRIL 2015,` 40

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CONTENTS Vol.10 No.12 APRIL 16-30, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta

PETvs GLASS THE DEBATE CONTINUES As the industry gears up to implement the switch from PET to glass for medicines meant for certain patient categories, the debate on the merits and demerits of both materials continues.

Usha Sharma reports | P28

DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

P14: POST EVENT IPGA, RDCA organise public awareness programme

Senior Artist Rakesh Sharma

P22: REPORT

Photo Editor Sandeep Patil

‘Pharmerging’ markets: Dealing with uncertainty

MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Mitesh Manjrekar CIRCULATION Circulation Team Mohan Varadkar

MARKET

10 PACKAGING SPECIAL

P26: RESEARCH UPDATE Foetal DNA tests prove highly accurate but experts warn of exceptions

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P39: INTERVIEW ‘We believe in creating innovative solutions for a variety of industries’

P64: APPOINTMENT ABLE elects new office bearers

‘INDIA IS SET TO OVERTAKE MOST EMERGING MARKETS ACROSS THE WORLD’

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BUSTING THE MYTHS AROUND BIODEGRADABLE PLASTICS

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MALVERN INSTRUMENTS: AN ORTHOGONAL APPROACH TO BIOPHARMACEUTICAL DEVELOPMENT

P41: VENDOR NEWS Chiltern ranks among top CROs in global survey of clinical research sites

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‘OUR GOAL IS FOR ALL UNITED NATIONS MEMBERS TO SIGN UP AN AGREEMENT ON POLICIES TO DEAL WITH ANTIMICROBIAL RESISTANCE’ CABINET CLEARS `4,187-CRORE GLENMARK, AUROBINDO PROPOSALS

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INDOCO ACQUIRES PIRAMAL’S CLINICAL RESEARCH DIVISION

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SANGH PARIVAR AFFILIATE PANS DRAFT IPR POLICY

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HAPPY OF GOVT’S PROACTIVE SUPPORT: GVK BIO CEO

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited 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 @ 2011. The Indian Express 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

Good growth prospects despite headwinds

A

s we settle into FY2016, it is worth taking a quick look at some of the earning previews of the last quarter. An Edelweiss Q4FY15 result preview report on the pharmaceutical sector blames currency headwinds in emerging markets and more importantly, a lack of meaningful ANDA approvals for the continued subdued earnings. Even so, over the long term, Edelweiss continues to remain bullish on the sector given the growth prospects and Indian pharma’s ability to execute, which is reflected in AIOCD’s monthly sales data reports. Considering that FY2015 started with a growth of 7. 3 per cent in April 2014, March 2015’s growth at 20.9 per cent offers some cause for cheer, especially since this makes it the fifth continuous month of double digit growth by the Indian pharma market (IPM). The Edelweiss report also points to the impact of consolidation within the industry and this too is mirrored in the AIOCD rankings.

But besides the big bang Sun Pharma-Ranbaxy deal, the first fortnight of FY2016 had some smaller but interesting deals, as companies chose different ways to counter the headwinds. Dr Reddy Laboratories’ decision to acquire UCB’s existing brand equity within India in three high growth areas — dermatology, respiratory and paediatrics diseases, — will further expand its therapy footprint, as well as add to the bottomline, considering that these businesses clocked approximate revenues of `150 crores in CY2014.

The accent on assets and brands continued with the two other deals announced in early April.

The first fortnight of FY2016 had some interesting deals,as companies chose different ways to counter the headwinds

Indoco Remedies’ acquisition of Piramal Clinical Research, the Hyderabad-based clinical research division of Piramal Enterprises and Quest Life Sciences' acquisition of Fortis Clinical Research Ltd (FCRL). Both deals give the acquirers quick growth in the clinical services sector, allowing Indoco to offer more depth to its clients while Quest gets a spurt to its growth plans.

These players are taking their cues from their global peers like Novartis. The company has sharpened its focus on key areas through a series of transactions in the past two years, culminating with last year’s three way asset swap with GSK and Eli Lilly. (See story, Bullish on India, pages 1620). Though the Indian subsidiary took a hit in a key therapy area, oncology, when it lost the patent (and perception) battle for Glivec, Novartis India's Vice Chairman & Managing Director, Ranjit Shahani is optimistic that Prime Minister Modi will make a difference on the policy front, given his industry-friendly image.

But these hopes may be shortlived. PM Modi is already facing internal opposition to his push for a national IPR policy. (See news story: Sangh Parivar affiliate pans draft IPR policy, page 12) Co-convenor of the Swadeshi Jagaran Manch Ashwani Mahajan’s blogpost is even more hard hitting, with the title ‘Don’t dilute Patent Act' a fair warning of his stance. Seems like PM Modi will have to weather internal headwinds and hardsell his vision to his party colleagues, yet again, before we see any signs of his promised achhe din.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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‘Our goal is for all United Nations members to sign up an agreement on policies to deal with antimicrobial resistance’ As the Obama administration chalks out a plan to combat the growing menace of antibiotic resistance, Jim ‘o’ Neill who was appointed by Prime Minister David Cameron to lead the review on Antimicrobial resistance talks to Shalini Gupta on his visit to India and how he plans to tackle this mammoth task How would you describe your role as the head of the AMR review?

I was formally appointed in July 2014, but took up the position only by September 2014. Our goal is for all United Nations members to sign up an agreement on policies to deal with antimicrobial resistance by September 2016.

We seek expert inputs from pharmaceutical companies including large pharma, boutique firms, specialist pharma, research specialists and policy makers from all over the globe on AMR which is what brings me to India. We are also in discussion to come up with a global innovation fund to stimulate more research. Going forward, the aim is to spend more time thinking about how better information to help us control the need for antibiotics which is very much consistent with the dramatic focus of the Modi government on sanitation.

What work has been done so far?

We spent the first two months researching and publishing an article in early December about the economic consequences the world will have to deal with if anti-microbial resistance goes unchecked. It revealed that if we do not find a solution by 2050, there'll be 10 million

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deaths with approximately more than a million in India.

The biggest causes for death and decrease in productivity were attributed to malaria more than TB, least of all HIV. E.coli would cost the highest in terms of superbugs.In a second article published in January this year, we wrote about the easy wins or straightforward ideas that'd be difficult to argue with, like trying to get more people to study microbiology in universities and offering doctors more rewards for research in microbiology and antibiotics for instance.

What has been the focus of your visit to India?

We believe a much bigger role should be played in improving diagnostics particularly in India which was one of the topics discussed on our visit to a diagnostic company in Gurgaon. We are also looking at how to incentivise and motivate pharmaceutical companies to produce more antibiotics. So our trip to India is to help familiarise us with the initiatives here and understand how we can synergise our ideas with them and encourage them to be even bolder to help create a global solution. This will be followed by a visit to China, then US, Brussels and EU. All of these efforts are targeted to

get policymakers to agree on a common agenda.

We are also looking at how to incentivise and motivate pharma companies to produce more antibiotics

What is the current status of antimicrobial resistance? Is there some data to support it?

First of all to get accurate and comparable data on antimicrobial resistance globally is actually very very difficult. The WHO should play a stronger leadership role in trying to promote greater commitment to better data.

For e.g. in the European database on resistance to some antibiotics, we discovered that some countries including some developed countries such as Germany don't report accurate data.

Its not that easy to say with confidence where India sits relative to other countries.

However, importantly based on research done based on evidence that we have, India is probably amongst the most vulnerable among developing nations alongwith China, Indonesia and some of the African countreis like Nigeria, primarily countries which have had a lot of infectious diseases or have challenges with them today.

If there is no concrete data on AMR, how did you arrive at the figure on the economic costs?

It was not easy, we made

clear in our paper that we need to make some basic assumptions, we warned people not to overestimate the exact figures that we quoted, for we believe that these numbers are very conservative. If anything the true vulnerability will be larger than the numbers that we reached at. What we did we asked two consultants to come up with projections for the world economy in the future assuming that there was no anti microbial resistance. Then as a second model we came up with projections based on resistance rates and infection rates, as to how productivity and employment and life will be affected looking at three possible pathogens and hospital superbugs. We also looked at three major infectious diseases- TB, malaria and HIV. Too few pharma companies are developing new antibiotics. Your views.

Its a key question which is worrying. Its not expensive and risky to devote resources to AMR, especially since they can't charge high prices and cannot sell them in huge quantities. In pharmaceuticals, companies are fashionably focussed on cancer research and we are trying to persuade, incentify them to have a different view.

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MARKET At a conference in London I said, “At the end of the day everyone is going to live in the same world, so one would need to think beyond the immediate profitability.” It is the truth.

So what is the solution?

What I am about to say are not agreed formal policies. One idea that we have is about an innovation fund, the size of which we estimate at $2 dollars. Initially, I was of the view that it needs to be financed by global multinationals such as IFC, World Bank, BRICS development Bank etc. To be honest with you, the more time I spent thinking about it, the more I want pharma companies to change their thinking and focus on social good rather than looking out for their own profits. I am interested in the idea of the top 25 pharma companies contributing to that fund, whether they are interested in AMR or not. My appeal to the pharma companies is that you live in an industry that requires regulatory support from governments and in many countries, favourable tax incentives are a part of it. If you only focus on the areas you want to focus upon and not focus on society's needs, then it may well be that governments will eventually be less favourable in the support that they provide you. With my own background in banking, I have seen how banks have been forced to think about the broader social good of people and so I am trying to persuade pharma companies to think differently. The recent example of AstraZeneca setting up a standalone company towards antibiotic research adds to my confidence, the fact that they set up a small specialist company which they're financing shows me that all pharma can do that. If this can be done by Top 25 companies in the world, it'd be great. It is a reality now that small specialist research companies are usually where the greatest findings take place. shalini.g@expressindia.com

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COMPANY WATCH

Cabinet clears `4,187-crore Glenmark,Aurobindo proposals The decision was taken by CCEA, chaired by Prime Minister Narendra Modi FOREIGN INVESTMENT proposals worth `4,187 crore by pharmaceutical majors Glenmark and Aurobindo were approved by the Government. The decision was taken by the Cabinet Committee on Economic Affairs (CCEA), chaired by Prime Minister Narendra Modi.

In February, the Foreign Investment Promotion Board had referred the proposals by the two domestic pharma majors to CCEA for clearance as each of them exceeded its clearance limit of `1,200 crores.

Mumbai-based Glenmark Pharmaceuticals had sought to raise the cap of foreign institutional investor or FII holding to 49 per cent from the current 35.07 per cent.

The move would facilitate the drug firm bringing in ` 2,022 crores of foreign funds into the country.

In Glenmark Pharmaceuticals, an official statement said, “the company has in-

In February, the Foreign Investment Promotion Board had referred the proposals by the two domestic pharma majors to CCEA for clearance as each of them exceeded its clearance limit of `1,200 crores creased the foreign investment limit by FIIs from 35.07 per cent to 49 per cent.” “This will result in an inflow of about `2,022 crores,” it said.

Apart from manufacturing pharma products, the company is engaged in R&D activities. It is a $1-billion Indian pharma company with a global presence that has facilities in India, Europe and South America.

On the other hand, Hyderabad-based Aurobindo Pharma proposed to bring in

`2,165 crores worth foreign investments by qualified institutional buyers.

Aurobindo Pharma is engaged in manufacturing generic pharma products, active pharma ingredients and approvals have been given for qualified institutional buyers to infuse fresh equity of “up to seven per cent amounting to about `2,165 crores into the company,” it said.

The existing FII shareholding is 27.32 per cent in the

company, it said, adding that “this will enable the company to expand its operations in the areas of anti-infective, cardiovascular and central nervous system related ingredients. Aurobindo Pharma employs more than 9,500 professionals from 26 countries.”

The statement said that both the firms are promoted

by Indian entrepreneurs who have developed a global footprint over the years.

They are required to continue to produce medicines under the National List of Essential Medicines (NLEM) at the same levels as they had been doing in the past, it added.

“These companies are also required to maintain R&D expenditure at the maximum levels incurred in the past three years and to provide complete information regarding transfer of technology that has been done,” it said.

PTI

DRL, Promius Pharma files NDAs with US FDA DR REDDY’S Laboratories and its subsidiary, Promius Pharma announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the US Food and Drug Administration (US FDA). The three NDAs – DFD-01, DFD09, and DFN-11, are in support of Dr Reddy’s Proprietary Products group, focused on developing and commercialising therapies in dermatology and neurology.

DFD-01 and DFD-09 are the first dermatology appli-

cations submitted to the NDA that have been fully developed leveraging in-house capabilities. DFD-01 is a corticosteroid delivered in a novel non-irritating spray platform, intended for the treatment of patients suffering from psoriasis. DFD-09 is a modified release oral tetracycline intended for the treatment of rosacea. DFN-11 is the first development programme filed in support of a newly created vertical, focused on the US neurology

market. DFN-11 is a drugdevice combination product intended to treat acute migraine episodes in certain patient populations who are inadequately managed with existing treatment regimens.

Raghav Chari, Executive Vice President of Proprietary Products, Dr Reddy’s and President, Promius Pharma said, “These products potentially represent new, compelling options for specific segments of patients suffering from psoriasis,

rosacea and migraine. They are also the first of a large basket of products targeting conditions predominantly treated by the medical dermatologist and neurologist.

By focusing exclusively on these two specialty therapeutic areas, we intend to build a leading presence in them over time.”

Upon approval, the products will be commercialised

by Promius Pharma.

EP News Bureau-Mumbai

MARKET

Indoco acquires Piramal’s clinical research division This facility is spread across an area of 30,000 sq ft and is equipped with a 98-bed facility INDOCO REMEDIES has signed a definitive agreement to acquire Piramal Clinical Research (PCL), a Hyderabad based Clinical Research Division (CRO) of Piramal Enterprises, on a going concern basis. This is an all cash-deal funded with internal accruals.

The CRO specialises in conducting bio-equivalence and bio-analytical studies for generic products. This facility is spread across an area of 30,000 sq ft and is equipped with a 98-bed facility, monitoring stations, phlebotomy stations, four-bed ICU, state-of-the-art analytical lab and capabilities of eCTD submission.

The CRO established under the name Wellquest in 2001 in Mumbai and later shifted to Hyderabad in 2007, has regulatory approvals from US FDA and was the first CRO from India to receive GCP certification from UK MHRA

to our existing R&D efforts, including facilitation of ANDA/Dossier filings”, said Aditi Kare Panandikar, Manag-

ing Director of Indoco Remedies.

The CRO initially established under the name Wellquest in

2001 in Mumbai and later shifted to Hyderabad in 2007, has regulatory approvals from several bodies including US FDA and

was the first CRO from India to receive GCP certification from UK MHRA. EP News Bureau-Mumbai

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MARKET

Sangh Parivar affiliate pans draft IPR policy Don’t dilute Patent Act, blogs Swadeshi Jagaran Manch co-convenor IN A hard hitting two page letter to Nirmala Sitharaman, Minister of Commerce and Industry, Ashwani Mahajan, Co-Convenor, of the Swadeshi Jagaran Manch (SJM) has delivered a detailed critique of the draft IPR policy.

Since the draft IPR policy is considered to have Prime Minister Modi’s blessings given his push to improve relations and increase business prospects with the US and other Western nations, industry observers have been (pleasantly?) surprised that the SJM, considered to be the economic wing of the Sangh Parivar, the mother organisation of the ruling BJP party, would take what is definitely a contrarian stance.

While the letter is undated, Mahajan’s blog post of March 24 is even more unambiguous in his stance on IP. Titled ‘Don’t dilute Patent Act’, he recalls PM Modi’s statement while addressing CEOs of US companies that “India is willing to accept the suggestions of a joint Indo-US working group on intellectual property rights” and asks what contentious issues need resolution and whether resolution of these issues is in the best interest of majority of India’s population.

Going to the crux of the

The letter warns that if implemented, it would further the technology dependency. It also lists five major issues that the SJM has with the draft policy matter, Mahajan makes the point that if Section 3(d) is diluted, then it may impact the prices of many drugs and thus the healthcare of 127-crore Indians and people around the globe.

In his letter to the Minister, Mahajan mentions the ‘undue hurry’ in which the think tank was formed, and blames this haste as the reason why it ‘does not reflect the development realities and needs of India’ and in fact ‘seriously undermines India’s technological progress in critical areas to address the development challenges of the nation.’

Citing Japan, South Korea and more recently China as examples of countries which ‘emulate technologies as strategy for technological catch up in order to move away from the technology dependency to technology generation’, Mahajan’s letter points out that

‘a domestic IP regime tilted towards protection and enforcement of IP rights without optimal use of limitations and exceptions would retard the attempts of technological catching up.’

Alleging that the draft IPR policy ‘proposes an IP maximalist agenda’, the letter warns that if implemented, it would further the technology dependency. The draft IPR policy does not gel well with even with the Prime Minister’s ‘Make in India’ initiative, according to the letter.

The letter then goes on to list five major issues that the SJM has with the draft policy, ranging from a lack of analyses and identification of India’s development needs, a disconnect between these needs and the six objectives outlined by the think tank, a contradiction between the draft policy and other initiatives like the ‘Make

in India’ campaign, the lack of proposed flexibilities to achieve national goals and lastly, the conflict of interest among the members of the think tank.

The SJM’s letter then ends with four suggestions to the Ministry of Commerce and Industry, to rectify these shortcomings. Reconstitution of the think tank takes prime importance, with the suggestion to ensure the involvement of academics especially with exposure to development economics, industrial policy, technology policy and innovation.

The second suggestion is to reorient the approach of the think tank and national IPR policy to address the technological and development needs of the nation, the third suggestion is to forgo the haste to formulate this policy and instead commission studies and consultations to identify the development and technological needs of the nation.

The last suggestion to the Minister of Commerce and Industry is to direct the reconstituted IP think tank to identify the suboptimal flexibilities in the national IP regime and make recommendations to optimise the use of flexibilities.

EP News Bureau-Mumbai

Drugs to cost just 20-30 per cent of price at Jan Aushadhi stores THE GENERIC drugs that would be made available at ‘Jan Aushadhi’ stores across the country would be made available at 20-30 per cent cost of its actual market price, Hansraj Gangaram Ahir, Union Minister of State for Chemicals and Fertilisers said.

Ahir said under the ‘Jan Aushadhi’ initiative to be launched in June, a total 3,000 such generic drug stores are proposed to be opened at government district hospitals, public health centres at block level and medical colleges, in one year in the first phase.

“We plan to open 50,000 such stores over a five-year period,” the Minister said adding, “medicines will be given to the poor and ‘aam admi’ at 20 to 30 per cent cost.”

According to a PTI report, Ahir said that only those who have a diploma or a degree or post-graduation in pharmacy and genuine NGOs with credibility would be given opportunity to run these stores. His ministry would give a subsidy of ` 2 lakhs to ` 2.5 lakhs to those selected to run these stores towards expenses to buy computer and show-case, Ahir said.

EP News Bureau-Mumbai

Merck Serono and MMV sign agreement To develop potential antimalarial therapy MERCK SERONO, the biopharma business of Merck, and Medicines for Malaria Venture (MMV) have signed an agreement for Merck Serono to obtain the rights to the investigational antimalarial compound DDD107498 from MMV. This agreement under-

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scores the commitment of Merck Serono to provide antimalarials for the most vulnerable populations in need.

“This agreement strengthens our global health research programme and our ongoing collaboration with Medicines for Malaria Venture,” said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at Merck Serono.

DDD107498 originated from a collaboration between MMV and the University of Dundee

Drug Discovery Unit, led by Prof Ian Gilbert and Dr Kevin Read. The objective of the clinical programme is to demonstrate whether the investigational compound exerts activity on a number of malaria parasite lifecycle stages, and remains active in the body long enough to offer potential as a single-dose treatment against the most severe strains of malaria.

While development and commercialisation of the compound is under Merck Serono’s

responsibility, MMV will provide expertise in the field of malaria drug development, including its clinical and delivery expertise, and provide access to its public and private sector networks in malariaendemic countries.

Merck Serono has a dedicated Global Health R&D group working to address key unmet medical needs related to neglected diseases, such as schistosomiasis and malaria, with a focus on paediatric populations in developing countries.

Its approach is based on publicprivate partnerships and collaborations with leading global health institutions and organisations in both developed and developing countries.

“Working with partners like Merck Serono is critical to the progress of potential antimalarial compounds, like DDD107498, through the malaria drug pipeline,” said Dr Timothy Wells, Chief Scientific Officer at MMV. EP News Bureau-Mumbai

MARKET

Happy of government’s proactive support: GVK BIO CEO Commerce Secy may take the GVK BIO case to WTO IN WHAT is probably the first instance of its kind, the Department of Commerce has decided to intervene on behalf of an Indian pharma company charged with data manipulation by overseas regulators, even threatening to take the matter to the World Trade Organisation.

Manni Kantipudi, Chief Executive Officer, GVK BIO informed Express Pharma that in late March, the Drug Controller General, (India) (DCGI) and Joint Secretary, Department of Commerce had travelled to Europe to visit officials of the European and French drug regulatory agencies to discuss their concerns.

Commerce Secretary Rajiv

decision. Inspite of the ANSM website stating that ‘this decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs’, GVK

BIO remains under a cloud.

GVK BIO was later invited by the European Medicines Agency wherein the company presented data and evidence to demonstrate that standard operating procedures were being followed

and all key activities such as dosing, blood sampling and processing were adequately controlled and supervised by qualified staff.

Kantipudi said, ““We are concerned about our reputation and integrity. The Clinical business

accounted for around 10 per cent of our overall revenue. As a business leader, I am happy of the government’s proactive support.

I am hopeful of a new era under PM Modi’s government.”

EP News Bureau-Mumbai

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The GVK BIO case dates back to May 2014, when a regulatory inspector from ANSM (the French drug regulatory agency, National Security Agency of Medicines and Health Products) had visited the Clinical Development facility of GVK Biosciences in Hyderabad and concluded that some of the employees had taken print-outs of ECGs from one volunteer and used them for other volunteers.

In September 2014, US FDA along with French and Dutch regulators visited the facility and cleared the ECG reports.

However the French agency remained firm on its earlier

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MARKET POST EVENT

IPGA,RDCAorganise public awareness programme More than 250 retailers and distributors of NCT Delhi were invited to participate in the session INDIAN PHARMACY Graduates’ Association (IPGA), in collaboration with Retailers and Distributors Chemists Association (RDCA), New Delhi recently organised a public awareness programme at FICCI Federation House, Tansen Marg, New Delhi.

More than 250 retailers and distributors of NCT Delhi were invited to participate in the interactive and participative session. Discussions were held on 'Prevention of Microbial Resistance to Antibiotics.'

Delegates from educational institutes also attended the awareness programme.

The programme commenced with briefing of all the delegates by Dr Arun Garg, Secretary, IPGA about the awareness programme and its importance.

Atul Kumar Nasa, President, IPGA and Managing Trustee, IPGA Welfare Trust in his inaugural address stressed upon the need of careful and restricted use of antibiotics. Sandeep Nangia, President, RDCA- Delhi thanked IPGA for organising such programme and touched the issue of online pharmacy and its legal validity of dispensing drugs.

Pawan Kumar Jaggi, Ex Head of Office, Drugs Control Department, NCT Delhi and Chief Executive PharmacyDelhi State Cancer Institute, Delhi chose to discuss Schedule H, Schedule H1 and Schedule X of Drugs and Cosmetics Rules, 1945. Jaggi, in his presentation, informed the delegates about the important implications of the Drugs Act and Rules. He recommended all the retailers as well as wholesalers of drugs to

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(L-R) Bhanu Dua, Prof Vijay Bhalla, Dr Arun Garg, PP Sharma, Atul K Nasa, PK Jaggi, Sandeep Nangia, Virendra Jain

Atul K Nasa, President, IPGA addressing the gathering

Discussions were held on 'Prevention of Microbial Resistance to Antibiotics.'

Delegates from educational institutes also attended the event

Members of RDCA Delhi participating in the seminar

adhere to the statutory provisions to avoid penalisation. He gave few illustrations to explain his point of view.

PP Sharma, Ex-Deputy Drugs Control, Drugs Control Department, NCT Delhi in his presentation informed the august gathering that microbial resistance is a great threat

to the society and is a matter of global concern. Sharma discussed in a very lucid manner various ways to prevent microbial resistance to antibiotics. He informed live stocks in poultry industry and veterinary usage of antibiotics are also one of the major contributing factors beside others.

In the open session, participants raised different issues relating to pharma trade which were ably handled by the experts in the field to the satisfaction of all concerned.

Vijay Bhalla, Treasurer, IPGA in his vote of thanks, thanked all the participants, resource persons, executive

members of IPGA, RDCA as well as management of FICCI. Kamal Mehrotra from RDCA thanked IPGA for organising this event and suggested that there should be many more such awareness programmes in the future too for the benefit of all concerned.

EP News Bureau-Mumbai

EVENT BRIEF MAY - 2015 05

Respiratory Drug Delivery (RDD) Europe 2015

RESPIRATORY DRUG DELIVERY EUROPE 2015 Date: May 5-8, 2015 Venue: Antibes, France Summary: RDD Europe 2015 will welcome pulmonary and nasal drug delivery experts from around the world. The joint organisers of the event, RDD Online and Aptar Pharma, will celebrate RDD Europe’s 10th anniversary and announce the opening of registration at www.rddonline.com/ rddeurope2015.

Contact details:

Elisa Eschylle, Events & Press Relations Manager Tel: + 33 (0)1 39 17 20 41 Email: elisa.eschylle @aptar.com

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000

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PHARMA Pro & Pack Expo 2015

pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services.

Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services and purchase officers.

Contact details

Indian Pharma Machinery Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg, Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272

IPHEX 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: Pharmexcil with Ministry of Commerce and

13

iPHEX 2015

Industry, Department of Commerce, Government of India will organise iPHEX 2015.

Over 400 overseas buyers from focus areas are being invited to participate in the exhibition. It will be co-located with PHARMA Pro&Pack Expo 2015.

Contact details Pharmaceuticals Export Promotion Council of India TV Indl Estate, Unit No. 211, 2nd Floor, 248-ASK Ahire Marg, Worli Mumbai – 400030 Tel: 91 22 24938750

The Standard of Comparison

Pharmaceutical Grade Crystalline, Spray Dried, Anhydrous, and Inhalation Lactose • For more than 70 years, we have delivered the industry's most extensive Lactose portfolio

www.SheffieldBioScience.com

• The original patent for Anhydrous Direct Tabletting (DT) Lactose • Batch to Batch Consistency • Global technical service, regulatory and application expertise to ensure regional and global market compliance

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Registered Office Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identification Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

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cover ) EXPRESS PHARMA EXCLUSIVE

BULLISH

INDIA

ON

Since 2013, Novartis has sharpened focus, with last April's asset swaps with GSK and Eli Lilly the next step in this process. In India, the Swiss company took a hit in April 2013 when the Supreme Court rejected its patent for its oncology drug Glivec. However Novartis India's Vice Chairman & Managing Director Ranjit Shahani is sure that while there will always be some road bumps, these will be temporary, asserting that they are in the right place at the right time

BY VIVEKA ROYCHOWDHURY

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THE MAIN FOCUS

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A

fter a cycle of diversification, pharmaceutical majors, at least globally, are firmly back to focusing on their core strength areas. Novartis' portfolio transformation, after last April's announcement of selected asset swaps with GSK and Eli Lilly, is just the latest confirmation that the era of big bang buys has given way, at least for now, to incremental consolidation.

While announcing the completion of the GSK transactions at a global level early this March, Joseph Jimenez, CEO of Novartis had said that this “focuses Novartis, and further establishes our leading positions in key growing business segments.”

This is in continuation of the Swiss major's efforts since 2013, to focus on three core verticals where they have achieved global scale: innovative pharmaceuticals, eye care and generics. (See box: Novartis: Transformative transactions since 2013) Divestment of Novartis' animal health division to Eli Lilly at a global level has already completed on January 1 this year.

In India, the company is still going through the regulatory processes to complete each of these transactions says Novartis India's Vice Chairman & Managing Director Ranjit Shahani.

The deal went one step closer to completion when GSK Pharma's board approved the transfer at its quarterly results meet in February.

The impact of these transactions will be seen in the FY 2015 global balance sheet, but the FY2014 results give some indication that the transactions will be profit neutral and will off load businesses which were recording operating losses as well.

Comparing results for the fourth quarter of 2014 and the same period in 2013 including the blood transfusion diagnostics unit, vaccines net sales declined 25 per cent (-20 per cent cc) and operating loss increased to $1.1 billion from $1 million in

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the year-ago period. Consumer Health net sales increased 5 per cent (+8 per cent cc) to $ 4.3 billion in 2014, driven by strong performance of key global brands and product re-launches in OTC (+9 per cent cc) and Animal Health (+5 per cent cc).

Comparing results for 2014 and 2013 including the blood transfusion diagnostics unit, vaccines net sales declined 23 per cent (-21 per cent cc) and operating loss for 2014 amounted to $ 552 million compared to a loss of $ 238 million in 2013.

Shahani, who joined Novartis India in 1997, a year after the mega merger between CibaGeigy and Sandoz, finds himself – once again- at the helm of strategic rebalancing act. The Novartis of today is itself a product of three major M&As (See box: Novartis timeline).

Given that the company is in the throes of a major global refocusing, Shahani concedes that M&As, divestments and

investments do impact operations and people. But as he points out, even though there were some job losses at the time of the Sandoz and Ciba-Geigy merger, the company today employs significantly more people than in 1996.

The current three-way asset swap is a very strategic move, he says, in the best interests of all the businesses of the companies involved, as well as the patients.

With Novartis' animal healthcare sold to Eli Lilly, i.e. Elanco goes from being a small player in the animal healthcare business, to one of the top three players.

Similarly, once GSK's oncology business is transfered to Novartis, the latter becomes the second largest oncology player. And this logic holds for when the OTC JV is formed with GSK and the vaccines business goes to GSK.

Impact of the Glivec verdict This April also marks another

milestone for Novartis India, this time a disappointment rather than an achievement. Two years after India's Supreme Court pronounced its landmark judgment against Novartis' Glivec on April 1, 2013, Shahani rues the fact that India lost the game (to attract pharma R&D spend) a while back.

To illustrate his assertion, he points out that since 2005, when we announced our entry as a product patent country, six global pharma companies – Pfizer, Astra Zeneca, Roche, Novartis, Sanofi and Eli Lilly - have invested in greenfield R&D centres in China, not India. Similarly, India would have been the logical place for Novartis to base its research in tropical diseases like dengue fever, TB and malaria; yet the Novartis Institute for Tropical Diseases (NITD) was set up in Singapore, as “global pharma companies will only invest where the ecosystem for IPR is

NOVARTIS: TRANSFORMATIVE TRANSACTIONS SINCE 2013 Sold ◗ January 2014: Completed sale of blood transfusion diagnostics unit to Grifols for $ 1.7 billion. ◗ April 2014: Announced three-way asset swap with GSK and Eli Lilly ◗ January 2015: Completed sale of animal health business to Eli Lilly and Company for approximately $ 5.4 billion ◗ October 2014: Divested influenza vaccines business to CSL for $ 275 million, transaction expected to close at the end of 2015 ◗ March 2015: Divested non-

influenza vaccines business to GSK for up to $ 7.1 billion plus royalties. The $ 7.1 billion consists of $ 5.25 billion paid upon completion and up to $ 1.8 billion in future milestone payments

Acquired ◗ March 2015: Acquired certain oncology products and two pipeline compounds from GSK, for an aggregate cash consideration of $ 16 billion. Up to $ 1.5 billion of this amount is contingent on certain development milestones ◗ March 2015: Novartis OTC creates JV with GSK Consumer Healthcare, combining two companies’ consumer divisions, in which Novartis owns 36.5 per cent share

encouraging.”

Even human capital has taken flight, with the brain drain of top talent in the R&D arena continuing, notwithstanding attempts, of both the Indian government as well as corporate India, to lure them back. Shahani gives examples from his own company, where the Head of Global Development and Head of Research in Europe, are both of Indian origin; no doubt just two of many such minds who choose to work globally rather than within the country.

The situation is particularly ironic when you consider that Novartis' predecessor company Ciba-Geigy was the first global major to set up an R&D centre in India, in Mumbai way back in 1963, inaugurated by the country's first Prime Minister Pandit Jawaharlal Nehru. A new molecule was discovered at this centre within a short period of 10-12 years. But post the switch from product to process patents in 1970, the company waited to see how the country's IPR policy would evolve but decided to pull the plug on the R&D centre in1982.

Mixed signals ...

Shahani's stance during the Glivec case was that the company pursued it up to the highest levels so that more light could be shed on the interpretation of Section 3(d) and other aspects of India's IPR policy. Today, two years down the line, Shahani says the IPR ecosystem in India remains very patchy. Compulsory licensing (CL), working of patents, etc continue to be mentioned by ministry officials while they are not in line with the IPR policies of other countries.

Shahani is encouraged by the fact that Prime Minister Narendra Modi seems to recognise this fact and has therefore called for an IPR policy to be formulated.

He also signed a bilateral treaty during his US trip, so Shahani concedes that there seems to be the right intent.

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The situation is particularly ironic when you consider that Novartis' predecessor company Ciba-Geigy was the first global major to set up an R&D centre in India, in Mumbai way back in 1963, inaugurated by the country's first Prime Minister Pandit Jawaharlal Nehru.

But he points out that at the same time the Minister of Commerce, Nirmala Seetharaman's stance is that India is TRIPS compliant requiring no changes to the IPR policy. To Shahani’s mind, this doublespeak is sending mixed signals to global pharma companies.

Referring to a recent development, he argues that if agrochemicals can get data protection increased from three to five years, he doesn't see any logical reason why the pharma sector too cannot have data protection. He refutes charges that data protection is TRIPS plus, saying that TRIPS too allows for data protection by specifying that other companies can refer and use the data submitted for approval only for research and not commercial purposes.

He cites these and other issues which remain open ended, and therefore don't give confidence to global companies to invest in research.

per cent of patients with chronic myeloid leukemia (CML) who are prescribed Glivec get it free. He calls it ironic that given this access programme, the government brought Glivec under price control and slashed its MRP by 93 per cent. According to him, the average annual weighted price of a paying Glivec patient in Novartis' Glivec access programme is Rs 5000/-.

In comparison a patient has to pay Rs 11000/- for the generic counterpart, which has come down further to Rs 9000/- thanks to price control.

He rues the fact that Glivec has unfortunately been in the news in India for all the wrong reasons, taking away from the scientific breakthrough behind it, referring to the fact that it specifically targets cancerous cells and fixes the malfunction, thus making a life-threatening disease a chronic illness that can be managed.

Pricing woes ... but India plans still in place Inspite of these setbacks on the IPR and pricing front, Shahani says the company will continue to launch new products in India to meet unmet medical need. Chronic heart failure drug LCZ696 and psoriasis medication Cosentyx (secukinumab) will be launched in India soon after their respective global launches.

These setbacks will also not prevent Novartis from continuing and expanding its patient access programmes and India-specific pricing strategy. Novartis launched its blockbuster diabetes drug Galvus, at a significant lower price and Shahani hints that there are other such product launches in the pipeline.

Even though the patent on Glivec was rejected, he points out that the company continues with the patient access programme for Glivec, through which more than 17,000 patients who are on Glivec continue to receive the drug free of charge i.e. more than 90

Besides IPR, drug pricing is another bugbear for pharma companies in India. While IPR divides the industry into propagators and the rest, the pricing issue often sees both camps on the same side.

Shahani, like all his peers, is disappointed with the increasing span of price control. He points out that the pricing policy was barely announced and in place, when the regulator ad hoc started to bring a larger number of drugs under price control – negating the two years and more of serious discussions by multiple stakeholders and the final approval by a cabinet sub committee. Various industry associations have protested that this will not help planning and strategic management in the pharma industry. Shahani reveals that while Ministry officials have been sympathetic up to a point, recent events show that nothing has changed.

Looking ahead, he cautions that the direction the drug pricing policy is

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cover ) taking will create challenges including those of access for many drugs as these will no longer be made by companies who see cash losses mounting.

Access and pricing are not necessarily interlinked, he points out and there is far more that a country like ours needs to do to improve access and it all begins with infrastructure.

In terms of ranking in the Indian pharma market (IPM), Novartis ranks 24th as per IMS Health’s Market Reflection Report for February, perhaps a reflection that MNCs, which constituted 26 per cent of the IPM, have taken a larger hit thanks to the drug pricing policy.

Shahani does concedes that companies like Novartis, and indeed all pharma companies in varying degrees, have been impacted by the drug pricing policy, but reinterates that his company will continue to launch new products to meet unmet medical need, while looking at creative ways to build market share. The company is also looking at projects such as PPPs to improve access and patient outcomes, says Shahani.

NOVARTIS TIMELINE 1758

1970

1996

1758-1970

Present

1970-1996

1996-present

>

Geigy

Ciba-Geigy

>

>

Ciba

Sandoz

>

Novartis Sandoz

>

>

NOVARTIS INDIA: PERFORMANCE APRIL-DECEMBER 2014 Total income from operations: ` 665.7 crore, up marginally from ` 660.6 crore in previous corresponding period. ◗ Pharmaceuticals: Total income of ` 455.5 crore up; from ` 442.9 crore in the previous corresponding period. ◗ Generics: Total income of ` 38.5 crore down from ` 43.9 crore in the previous corresponding period. ◗ Animal health: Total income ` 71.1 crore down from ` 82.7 crore in the prior corresponding period. ◗ OTC: Total income ` 100.8 crore up from ` 91.1 crore in the previous corresponding nine months.

The BoP model Novartis India was one of the earliest MNC pharma companies to have a strategic plan to tap rural markets in India through the Arogya Parivar initiative. Started in 2007, based on an idea from Prof C K Prahalad who wrote the book, The Fortune at the Bottom of the Pyramid, Shahani says that it has been a great success, expanding to 11 states across rural India. Giving an update, he shares that for the last four year period, more than 10 million villagers attended health education sessions and 450,000 were diagnosed in health camps. Arogya Parivar is now embarking on further expanding the rural distribution network and portfolio in India.

The model has been replicated and expanded to countries like Kenya, Indonesia and Vietnam after adapting the model to suit local conditions.

As a market penetration strategy for Novartis' products, across branded generics OTCs and pharmaceuticals, Arogya

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Parivar makes perfect business sense, tapping into a large market. Rural India makes up 11 per cent of the global population with huge unmet medical needs.

But Novartis is aware that medicines are just one side of the problem in rural India; lack of doctors and diagnostics is a larger problem. Which is why Novartis, in partnership with Indian Cancer Society held cancer screening camps in Maharashtra in March and with other NGOs for similar camps in Seemandhra and Telangana.

Reputation reversals The Indian government is not alone when it comes to scrutinising Big Pharma. Many countries, China being the most cited, have cracked down on global pharma's unfair marketing practices and Novartis too has been pulled up on some occasions on this count. Shahani states that they do not tolerate unethical behaviour by their

associates anywhere in the world and at Novartis India, they are committed to creating a culture of integrity and demonstrating ethical leadership.

Being seen as an very regulated sector as well as one facing the backlash from government and lay society, has meant that the industry has to struggle to attract talent. Novartis tries to counter this with initiatives like the annual BioCamp, but Shahani points out that while the BioCamp participants certainly are a rich talent pool, they do not see this as a recruitment tool but as a way to expose bright young minds to the opportunities in the healthcare industry, be it at Novartis or elsewhere.

He's proud of the fact that two of the BioCamp India participants went on to become global individual winners, (coincidentally both women) and affirmation of the talent that exists in the country.

Even with the competition the industry faces from other more glamourous and fast growth sectors like BFSI and FMCG, Shahani points out that they have around 7000 employees in India and are a net exporter of talent to Novartis Group, with the Hyderabad operations providing high-end services to Novartis Group right up the value chain, all affirmation of the “tremendous talent we have in our country.”

Looking ahead Novartis India's predecessor companies Ciba-Geigy and Sandoz were one of the earliest MNC pharma companies to start manufacturing in India way back in 1947, when as Shahani points out, most companies were trading in their products.

That showed a strong intent of investing and growing in the country, even given the transition which the country was going through.

As we near our 69th Independence Day, Shahani reinforces this commitment. Novartis intends to stay and grow in India with the company expanding its presence not just through its product portfolio. but also on the manufacturing front, through the company's Turbhe, Kalwa and Mahad sites. Novartis India is today also an outsourcing destination for its global parent for some APIs and IT services as well.

Thus the India operations are a very important part of Novartis' global strategy, says Shahani. There are opportunities but also disappointments, like the Glivec incident, along the way. But on the whole he is hopeful that there will be a change thanks to the new government, referring to the DIPP's taking a “more mature stance” on CL applications. He advocates the need to look for pragmatic solutions, pointing out to many low hanging fruit that can be dealt with quickly, like data protection, etc. The situation is better today, with many MNC pharma companies launching new products in India soon after their global launches, and at India/Asia-specific pricing.

India, in some cases is the biggest beneficiary of Novartis' global access programmes, for instance, Novartis donates almost 100 per cent of the world’s supply of leprosy drugs to WHO and more than 60 per cent of these drugs come to India.

He opines that rather than focusing only on pharma companies, we need to look at healthcare in a more holistic manner, suggesting that insurance and improved health infrastructure could be two ways of improving access to quality healthcare as well as affordable healthcare.

But for this, he stresses that all stakeholders need to come together.

Summing up, Shahani is optimistic that Novartis India is in the right place at the right time.

“There will always be some road bumps but these will be temporary. India is a key country for Novartis Group and we would like to build on the progress we have made,” he sign offs. viveka.r@expressindia.com

MANAGEMENT REPORTS

‘Pharmerging’markets: Dealing with uncertainty Executives in the life sciences industry reveal their key concerns in cross-border acquisitions in pharmerging markets A RECENTLY published Baker & McKenzie report shows that global pharmaceutical companies continue to set their sights on emerging markets, but are cognizant of the challenges these markets can present.

From 2012 to 2017, global pharma sales are expected to rise 13 per cent in 'pharmerging markets,' compared to just two per cent for the top mature markets, such as the US, according to the IMS Institute for Healthcare Informatics.

“Key growth markets include China (16.1 per cent, valued at $100.6 billion), India (13 per cent, valued at $17 billion) and Venezuela (56.4 per cent, valued at $15.3 billion). Businesses are attracted to these pharmerging markets for a number of reasons,” explains Jane Hobson, Head, Baker & McKenzie's global life sciences industry group.

"Many governments in these markets are making large investments in healthcare, such as the Chinese government’s announcement in 2009 that it would spend $124 billion over 10 years to expand healthcare coverage

22 EXPRESS PHARMA April 16-30, 2015

With multiple challenges facing the global healthcare industry, many major drug companies have been turning to acquisitions for its 1.3 billion citizens and invest in projects such as upgrading and constructing new hospitals and health clinics in areas ranging from urban centres to remote villages," informs Hobson.

With multiple challenges facing the global healthcare industry, many major drug companies have been turning to acquisitions and licensing transactions over R&D investment to grow their profit margins and boost share value. In fact, 2014 was a record-breaking year for M&A in the healthcare sector, with deal values reaching $363 billion, 94 per cent higher than those in 2013. Of those deals, $178 billion - almost 50 per cent were cross-border transactions involving buyers acquiring target companies or assets in countries outside their local markets.

But, while investing in pharmerging economies can bring significant benefits, it is not without challenges. Not

surprisingly, life sciences executives cited compliance and regulatory challenges as the two areas which cause the most concern and can be detrimental to business if not managed properly. The Baker & McKenzie report, 'Dealing with Uncertainty' therefore sets out a number of recommendations on how to plan for these challenges and handle them appropriately.

In China, for example, Tracy Wut, Co-Chair of Baker & McKenzie’s Global Life Sciences Industry Group explains, "A lot of domestic companies don’t have robust corporate compliance programmes or they may have policies but they’re not closely monitoring or strictly enforcing them. The buyer may need to educate the target’s management on the importance of compliance from the start, and target problem areas quickly.”

Based on answers from 49 life sciences executives surveyed for Baker & McKenzie’s 2014 ‘Going Global’ M&A report

EP News Bureau-Mumbai

MANAGEMENT

Top mid-cap biotech firms’total revenues increase to $26.5 bn in 2014: GlobalData The company’s latest report states that this growth was marginally slower than during the previous five years The combined total revenues for the peer group of 35 midcap biotech companies increased from $24.8 billion in 2013 to $26.5 billion in 2014, representing a compound annual growth rate (CAGR) of 21.9 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this growth was marginally slower than during the previous five years, as total revenues for this peer group expanded at a CAGR of 25.2 per cent between 2009 and 2013.

Adam Dion, MS, Global-

24 EXPRESS PHARMA April 16-30, 2015

Data’s Healthcare Industry analyst says the rise in biotech peer group total revenue over the past year was driven by Regeneron and Alexion, both of which posted sales of more than $2 billion in 2014.

Dion explains, “Regeneron’s sales grew by 34 per cent in 2014, as the company continued its commercialisation of Eylea (afilibercept) to markets outside the US, including for the treatment of macular edema secondary to central retinal vein occlusion in both the EU and Japan.

“Alexion saw sales from its orphan drug Soliris (eculizumab) increase from $1.6 billion in 2013 to $2.2 billion in 2014. Alexion reported a higher volume of unit shipments and better-than-expected demand for Soliris across all geographic regions, especially in the EU, thanks to a reimbursement agreement with the French government.”

The analyst adds that Pharmacyclics, which was acquired by pharma giant AbbVie last month, was the peer group revenue growth leader in 2014.

Its sales shot up by 180 per cent in 2014 to $729 million, representing an absolute dollar increase of nearly $470 million.

GlobalData attributes this surge to Pharmacyclics recognising nearly $493 million in new product revenue from sales of Imbruvica (ibrutinib), the company’s first-in-class BTK inhibitor approved to treat blood cancer patients with chronic lymphocytic leukemia and mantle cell lymphoma.

By contrast, some companies experienced sales de-

creases, most notably Vertex, which saw revenues decline by 52.1 per cent, from $1.2 billion in 2013 to $580.4 million in 2014.

Dion comments, “This drop was largely attributable to sliding sales of Incivek (telaprevir), Vertex’s hepatitis C virus protease inhibitor, which fell by $442.3 million compared with 2013, primarily as a result of increased competition from Gilead’s Sovaldi (sofosbuvir) and Janssen’s Olysio (simeprevir).”

EP News Bureau-Mumbai

RESEARCH RESEARCH UPDATES

Foetal DNAtests prove highly accurate but experts warn of exceptions Women who test positive still need to confirm the result through more invasive diagnostic testing such as amniocentesis, especially if they would consider terminating a pregnancy A ROCHE blood test to screen foetuses for Down syndrome worked far better than standard prenatal screening tests in younger, low-risk women, US researchers said, setting the stage for more widespread use.

The new study, published in the New England Journal of Medicine, is the largest to show the tests are accurate in even low-risk women. But experts warned that women who test positive still need to confirm the result through more invasive diagnostic testing such as amniocentesis, especially if they would consider terminating a pregnancy.

“This is a great test for detecting Down syndrome but it doesn’t detect everything, it isn’t diagnostic, and it doesn’t always work to provide a result,” said Dr Mary Norton of the University of California, San Francisco.

Prior studies have shown such foetal DNA tests, which measure DNA fragments from the placenta circulating in the mother’s blood, are highly accurate at detecting Down syndrome and two other chromosomal abnormalities in high-risk women, typically those over the age of 35.

Several physicians’ organisations have supported use of the newer cell free foetal DNA tests over the standard screening in older, high-risk women. Norton and colleagues tested nearly 16,000 women who had an average age of 30. The researchers compared Roche’s Harmony test to standard prenatal screening for Down syndrome

26 EXPRESS PHARMA April 16-30, 2015

- which relies on biomarkers in the blood and a fetal ultrasound - in the same group of women. The Roche test identified all 38 cases of Down syndrome compared with 30 detected by standard screening.

The false positive rate for the new fetal DNA test was 0.06 per cent of the study population versus 5.4 per cent for standard screening.

But there were still nine false positive results in the group that got cell free fetal DNA screening. In addition, in nearly 500 women the foetal DNA test was not able to deliver any result because there was not enough foetal DNA in the pregnant women’s blood.

Further testing, however, showed that some 2.7 per cent of foetuses had chromosomal

defects, including those that could not have been detected by the new foetal DNA technique. More than one million fetal DNA tests have been performed since 2011. One of their advantages is that if women test negative, they can avoid having an invasive diagnostic test, which can cause miscarriages in roughly one in 600 women.

But the newer tests are not regulated by the US Food and Drug Administration, and companies are heavily promoting their performance in ways that may mislead patients, critics say.

In a letter published in the New England Journal of Medicine, Ankita Patel and colleagues from Baylor College of Medicine and the Chinese

University of Hong Kong warn that women should not decide to terminate pregnancies based on such screenings alone.

They cited their own work that collected data on 307 women who screened positive on foetal DNA tests. The results included 56 false positives, meaning the child did not have Down syndrome or the two other common abnormalities (trisomy 13 and 18) captured by the tests. In some cases, women had already scheduled an abortion pending amniocentesis results, a test given between 15 and 20 weeks of pregnancy. Even when that diagnostic proved the child did not have those abnormalities, some women questioned whether the

screening result was more reliable.

“They think it is a diagnostic test because it's genetic,” Patel said of the foetal DNA tests.

Another reason for the confusion is the rapid introduction of this new technology. Many doctors are still just learning about it, said Dr Michael Greene, Chief of Obstetrics, Massachusetts General Hospital in Boston, who was not involved in the research. He also points to companies’ aggressive marketing of their tests on the Internet.

Ariosa Diagnostics, acquired

by Roche in January, says its Harmony test for fetal chromosomal abnormalities offers “clear answers to questions that matter,” promising “accurate results from as early as 10 weeks of pregnancy.”

Rival Sequenom says on its website that it offers unambiguous results: “There’s no room for maybe.” Other companies offering such tests include Illumina and privately-held Natera. Greene said many women are not aware that these tests are not diagnostic and company disclaimers are not easy to find. Both Sequenom and Ariosa said they recommend healthcare providers counsel their patients that the screening test is not a replacement for a diagnostic test. The FDA is weighing whether to regulate such tests. Patel believes the oversight might help because the tests “would have more disclaimers so women understand what they are getting into.”

Reuters

Merck,NewLink Ebola vaccine appears safe, effective in new studies The trials tested a vaccine called VSV-ZEBOV, which was developed at the Public Health Agency of Canada and licensed to NewLink Genetics Corp and then to Merck & Co EARLY-STAGE trials of an experimental Ebola vaccine, two in the US and four in Africa and Europe, have found that it appears to be safe and triggered robust production of Ebola-fighting antibodies, scientists reported.

Since trials cannot ethically expose volunteers to Ebola, the production of antibodies is a proxy for whether vaccines could prevent or even treat the disease. There is currently no vaccine or specific treatment for Ebola, which has killed over 10,000 people in West Africa since last spring, according to the World Health Organization. It is the worst Ebola epidemic in history, but finally appears to be abating.

The trials all tested a vaccine called VSV-ZEBOV, which was developed at the Public Health Agency of Canada and licensed to NewLink Genetics Corp and then to Merck & Co. It consists of a cattle virus called rVSV that has been engineered to carry Ebola genes, which produce proteins meant to trigger production of anti-Ebola antibodies.

According to separate teams of scientists, that is what happened, two papers in the New England Journal of Medicine reported. In the US trials, conducted independently but cooperatively at

the National Institutes of Health and the Walter Reed Army Institute of Research starting last October, 52 healthy adult volunteers received single injections of saline or either of two doses of vaccine. The most common side effects were mild, such as pain at the injection site and short-lived fever. All 40 participants who received vaccine produced anti-Ebola antibodies within 28 days, with most responding sooner. The higher dose triggered triple the antibody response of the lower dose. The “robust” response to a single dose “could be particularly useful in outbreak interventions,” said Walter Reed's Col Stephen Thomas, senior author of the US paper.

The higher dose is being tested in a larger trial in Liberia. Partly through that trial, both VSV-ZEBOV and an experimental vaccine from GlaxoSmithKline called cAd3-EBOZ “appear to be safe,” NIH announced last week.

The other studies were similarly encouraging. In coordinated trials in Germany, Switzerland, Gabon and Kenya, 158 healthy volunteers received a placebo or any of five dose-levels of VSV-ZEBOV vaccine. Although the Geneva study was temporarily halted last year after 11 of 51 participants developed arthritis, overall there were “no serious vaccine-related adverse events,” the researchers reported. All 150 people who received vaccine developed antibodies to Ebola with higher responses to higher doses.

Reuters

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PACKAGING SPECIAL

PETvs GLASS THE DEBATE CONTINUES

As the industry gears up to implement the switch from PET to glass for medicines meant for certain patient categories, the debate on the merits and demerits of both materials continues. Usha Sharma reports

T

he Central Drugs Standard Control Organization (CDSCO), Director General of Health Services, Ministry of Health and Family Welfare, Government of India is working on a mission to safeguard and enhance public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices. The government feels that PET packaging will harm pregnant women, child and geriatric populations and to address this issue the Ministry of Health and Family Welfare (MoHFW) had issued a notification banning the use of polyethylene terephthalate (PET) as a primary packaging material for liquid oral drugs on October 19 last year, which followed a draft notification (GSR 701(e)) issued on September 29.

By April this year, manufacturers of pharma products in India will be banned from using PET as primary packaging for these specified formulations.

The announcement was welcomed by the glass manufacturers whereas PET manufacturers were disheartened. Realising the industry's concern, Indian Drug Manufacturers’ Association (IDMA) has made the represen-

28 EXPRESS PHARMA April 16-30, 2015

tation to DTAB on December 20, 2013 to suggesting a rethink about the issue.

Commenting on IDMA's move, Sanjay Tiwari, Chief Executive Officer, Piramal Glass Ceylon says, “The Government of India should act based on the health advisory from the experts.Already many doctors have raised support for glass due to strong evidence of adverse effects on human health due to plastic/PET packaging. GoI has issued this pre notification only after seeking opinion from expert committee and ICMR. Any other alternative in favour of PET manufacturers will be seen as taking a step back from their decision.”

A welcome move?

The step initiated by the Government of India to ban the PET bottles indicates that the government is concerned about the health of the Indian population.

But a point to be noted is that until few years back most drugs manufactured by pharma companies used glass bottles and later shifted to PET bottles. Why did this shift not raise alarm bells in the government at that time? And if it is mandatory to stop using PET bottles then em-

ployees of both pharma companies as well as pharma logistic players need to be well trained and prepared to handle glass bottles, especially while the products are in transit.

To this Tiwari counters, “All these medicines were earlier filled in glass. Even now the pharma industry is using 30 per cent of their current packaging requirement in glass. Of late some of the products have moved to PET packaging, hence there is no need for any training.”

However, Pranay Kumar, Chief Environment Officer, Vasudhaecofriends Projects feels that the industry is not prepared at all to follow the rule. He opines, “Pharma professionals would be well advised to go for elaborate testings for leachates/extractables at various temperatures and a repertoire of chemicals with glass and PET. I don’t think they should bow to NGT or Government with solid scientific evidence, specially with loads of information against the proposition.

Plastics have made many revolutions possible, including milk, oil and plays a very large role in saving food in a country like ours. Logistics (weight, breakage, costs) and supply chain

would be paralysed for a short time (four-six months) packaging.”

Critics of PET point out that it adds to the plastic waste but as a sustainability activist, Kumar has an answer for this charge.

His company Vasudhaecofriends promotes, EcoPure, a range of organic copolymer additives, which accelerates the biodegradation of traditional, oil-based plastic products in a biologically active landfill. (Read his article: Busting the myths around biodegradable plastics, pages 31-35 in this issue). It remains to be seen if technology will be used by the pharma industry because it will obviously add to the cost, but it certainly addresses one of the concerns.

Challenges involved Logistics play an important role in the pharma supply chain as it connects pharma companies to the end consumers. PET bottles are easy to handle during the transit period whereas glass bottles may require a different set of understanding about glass handling. Commenting on whether logistics players require training to handle and follow glass bottle packaging, Tiwari says, “As far as logistics players

are concerned, they are doing transportation for both types and there is no requirement for any specialised transportation for glass.”

With the implementation of glass packaging, it is likely that manufacturing costs will shoot up drastically. Tiwari comments, “The cost escalation in switching over from PET to glass is negligible, keeping in mind the potential harm it can create for our coming generation.”

He explains further, “The additional cost to manufacturers and end consumers will be negligible. Let’s take an example of a 100 ml glass bottle for the pharma industry. It can cost landed to the manufacturing location at ` 2.0 per PET bottle of 12.5 grams. In glass, a 100 ml bottles can cost at `2.6 per glass bottles of 100 grams weight. If we compare this additional cost of ` 0.60 per container, the pharma product sold in the market of 100 ml can be any where between ` 70 to ` 100.”

Kumar opines and feels, “The manufacturers, sellers all would have many concerns and costs to look into. Many pharma remedies may vanish or would be in short supply for months to come.

And there are instances where

The cost escalation in switching over from PET to glass is negligible, keeping in mind the potential harm it can create for our coming generation

The decision was completely ill informed by the government and there is no alternative to plastics packaging Pranay Kumar, Chief Environment Officer, Vasudhaecofriends Projects

Sanjay Tiwari, Chief Executive Officer, Piramal Glass Ceylon

similar formulation is being packed in glass for exports from India as well as plastic for domestic consumption.”

Market share Presently, the glass industry has a capacity of 10,000 TPD and currently almost 20~25 per cent capacity is idle, which can be utilised for the pharma industry.

Hindusthan National Glass, AGI – Glasspac, Piramal Glass, Empire Industries, Gerreshiemer India, are few of the leading glass manufacturers in India catering to the pharma industry. Apart from them, there are many other glass companies like Haldyn

Glass, Sunrise Glass, Canpack which have sufficiently large capacities and cater to other segments like the food & beverage industry.

Glass containers are witnessing a growth of eight~10 per cent year-on-year, however the requirements by pharma industry has declined year on year due to a large shift from glass to PET. It is estimated that 35000 MT of PET Amber is used for the pharmaceutical industry and it is witnessing a growth of eight to 10 per cent year on year. Tiwari emphasises, “The glass industry is fully prepared to cater to any additional requirements of glass

containers for pharma usage.

We have already received indications from major brands about their desire to shift to glass packing mode and are ready for the same.”

So, how badly hit will the PET manufacturers be if glass packaging in pharma becomes mandatory? Largely all PET manufacturers have the capability to service various sectors like food, beverages, liquor and many others. Tiwari avers, “In terms of the total capacity available in PET container industry, very small portion of the capacity is toward manufacturing containers for the pharma industry and

hence again the impact will be very marginal.”

Kumar anticipates that thousands of small companies will be shut down, with lakhs of people unemployed. He says, “Glass also has high pollution associated with manufacturing.

The decision was completely ill informed by the government and there is no alternative to plastics packaging. The only other plastic is HDPE for pharma packaging. If NGT is worried about waste, country should look into biodegradable plastics.”

He feels, “The PET industry is not well versed in technologies

and they never care to update themselves against challenges like NGOs petitions. Most end consumers like TATAs, Nestle, pharma companies do their time in fire fighting. There is no future or scenario planning. ” Tiwari concludes, “PET manufacturers have fairly big opportunities in other segments such as food, beverages, liquor which are showing healthy growth rates.”

Thus, while the move has evoked a mixed bag of reactions from the industry, the ramifications of it are yet to be seen. u.sharma@expressindia.com

PACKAGING SPECIAL I N T E R V I E W

‘India is set to overtake most emerging markets across the world’ With ACG as its partner and five major clients in its kitty, Dara Pharma Packaging is improving its clientele list. Alfred Terés, Sales Director, Chemical Engineer, Dara Pharmaceutical Packaging talks to Usha Sharma, about the company’s future growth prospects

How long have you been associated with ACG and how do you plan to strengthen the partnership?

Dara Pharma Packaging’s partnership with ACG started in June 2011. We have improved our partnership by providing training and specific knowledge about our lines and the aseptic filling to ACG sales engineers and after sales technicians. Nowadays, ACG is one of our best partners around the world.

Under the existing partnership, what services do you offer to the customers? Who are your clientele?

Mainly, we provide advisement to our customers.

Sometimes the best service you can provide is to offer different options to carry on their projects. By listening to the specific demands of the customer, we can provide specific technical solutions further than just a simple machine. We have five big clients at the moment from India, with the list still growing.

Which therapeutic applications do you offer?

Are there any new therapies in the pipeline?

We design, build and install machines for filling, closing, labelling vials, syringes, cartridge, eye drops and many new devices that time to time appear to improve actual

30 EXPRESS PHARMA April 16-30, 2015

therapies. Customers and material suppliers proposed new devices and we design the machines to make it possible.

India has the intellectual expertise, trained cheap manpower,excellent infrastructure, requisite experience supplying to the regulated and semi-regulated markets, backed by an ambitious Indian government

Which services differentiate your company from the rest and are they cost effective?

We offer customised and cost-effective solutions compared to the rest of the global manufacturers. These solutions may result in saving space and time as well as offer flexibility and uniqueness to our customers.

What do customers expect from machinery manufacturers?

I think more and more customers expect to have a specific solution for their requirements. Maybe in the past it was more common to adapt the requirements of the customer to standard machines. Even that causes some inconvenience in space, real production demand or flexibility. It was very usual to have various machines for different applications even if they were just running partially or where many small machines run at multiple shifts making the production very inefficient. Now, customers like to have tailormade solutions. They like to get maximum profit out of their investment from the space reserved for a determinate production.

What makes you feel that

I think more and more customers expect to have a specific solution for their requirements

India will become a main market for the global pharma industry? How are you going to expand your presence further in India?

India has the intellectual expertise, trained cheap manpower, excellent infrastructure, requisite experience supplying to the regulated and semi-regulated markets, backed by an ambitious Indian government.

Hence, all the necessary ingredients are in place. We will cater to an increasing requirement of formulations going off patent and waiting to be tapped for manufacturing in India. This in turn will provide us with the opportunity to increase our footprint in India.

Will India be a hub for Asia Pacific market to Dara Pharma?

Yes, all eyes are set on India, as they are set to

overtake most emerging markets across the world.

What trends do you observe in the global pharma packaging market? How do Indian players fare and are they at par withe players in the developed nations?

New trends are ready-touse devices, lines inside isolator just to improve sterility of the process, flexible line for multiple presentations of the same product, new devices. The pharma sector is still constantly evolving. I believe the Indian players (machinery manufacturers) have still some catching up to do with respect to quality and other deliverables expected from the customers. I am sure with time and exposure to European machineries, they would eventually be able to pace up things. u.sharma@expressindia.com

PACKAGING SPECIAL

Busting the myths around biodegradable plastics

PRANAY KUMAR, Chief Environment Officer, Vasudhaecofriends Projects

Biodegradable plastics have been debated in different media and fora but there is more confusion than clarity on the facts. In the light of the ban on PET in pharmaceutical packaging for certain patient categories, sustainability activist Pranay Kumar, Chief Environment Officer, Vasudhaecofriends Projects clears the air on some of the issues and makes the case for products like Ecopure, which increase the biodegradability of plastics, making it more ecofriendly A LOT of debate has been generated in different media and fora on biodegradable plastics, bioplastics, standards, methodologies and their applications.

The Ministry of Environment & Forests’ notification on plastic (waste) management, 2011, gutkha plastic packaging ban and recent intervention by the honourable Supreme Court of India on Karuna society’s plea for banning plastic bags have made it necessary to clear the air on the technologies, sustainability of each category of degradable plastic, application and legalities.

Overview In early and mid 20th century, as the world searched for a light, flexible, strong and inert material for packaging of different products from machines to cosmetics, from water to milk, from wires to pipes, plastic proved its worth.

Some advantages of plastics : Versatile, non harmful to many types of food, flexibility in shape and forms; films to highly rigid structures, ability to withstand very high and very low temperatures and pressures, optical properties ranges from completely opaque to transparent like water, usage in research labs with highly corrosive chemicals and even making rocket nozzles.

Consider the facts about plastics: Plastic encases about 53 per cent of products we buy; it only makes up 20 per cent by weight of the packaging we consume. In comparison, glass as a

India as a country has been able to bring in ‘white’ (milk) and gold (edible oil) revolutions due to plastic. 50 per cent of India’s food is wasted due to lack of proper storage and packaging. Plastic packaging can save more than 25 per centof the food. Despite of these advantages plastic has been made a villain in eyes of common citizens and the courts packaging material also accounts for 20 per cent of the packaging we consume by weight, but only 10 per cent of the goods we buy. And in the packaging equation, weight is the main issue because the heavier something is, the more energy you expend moving it around!

Paper and recycled paper is perceived to be ‘ecofriendly.’

This author’s research suggests nothing can be far from truth.

Paper and recycled paper (except for handmade paper) have high energy, water and carbon footprint 1. Making of paper is a highly water intensive process which pollutes the environment, besides cutting of millions of trees.

India as a country has been able to bring in ‘white’ (milk) and gold (edible oil) revolutions due to plastic. 50 per cent of India’s food is wasted2 due to lack of proper storage and packaging. Plastic packaging can save more than 25 per cent of the food. Despite of these advantages plastic has been made a villain in eyes of common citi-

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zens and the courts.

One of the biggest advantages of polymers, non degradability emerged as one of its biggest disadvantages. As a result of exponential in population, rise in standards of living and excessive consumerism {without a sense of responsibility towards the environment and other living species} plastic, especially polyolefin films and sheets have emerged as an environmental threat.

But we should ask ourselves, is plastic to be blamed or we should be responsible for its indiscriminate use? Under fundamental duty of the Constitution we, the citizens of India are responsible for our environment.

After all plastic does not decide to litter itself!

Biodegradable plastics have a potential to become one of the best solutions for plastic waste management, especially for end of life solutions and plastic products which cannot be recycled or reused. Yet biodegradability cannot and should not be used an excuse for overuse/littering.

Terminologies and technologies for degradability Before we describe the technologies let's understand the terminologies according to international standards and methodologies.

Standards are specifications set by recognised international/ national agencies, like ISO (international), ASTM (American), CEN (European), DIN (German), OECD and JIS (Japan) under which degradability parameters are defined.

Methodologies are defined procedures/processes to determine a particular result. It should be noted that same standard can be determined through different procedures like standards ISO 14855/ASTM D 6400 can be determined either through ASTM 5338 or any other EU/ Japanese/National standards.

In India there is a lot of confusion between standards and methodologies. Terms such as biodegradable, compostable, degradable, photodegradable, oxodegradable have added to the confusion in India.

Terminologies for degradation in context of polymers/plastics Biodegradable: Simply speaking, biodegradable means degradable into biomass and gases (like CO2 and CH4) in presence (aerobic) or absence (anaerobic) oxygen because of action of microbes (mostly fungi and bacteria like actinomycetes).

These are mostly made up from petroleum resources. Companies like BioTec Environmental manufacture the biodegradable additives.

Bioplastics: Partially or fully made up of starch/polysaccharides/ aliphatic polyesters, either natural or synthetic and mostly aerobically biodegradable.

These can be subdivided into PLA (Poly-lactides), PHA (Polyhydroxyalkanoates), PHB (polyhydroxybutyrate), PCL (poly ecaprolactone) and PVOH (Polyvinyl alcohol).

Starch (polysaccharides) PHA and PHB are naturally occurring, while PLA, PCL, PVOH, PCL are synthetic. These are mostly derived from plants’ sources and even food crop sources (like corn or potato).

MNCs like Novamont and Dow Cargill manufactures these.

Oxodegradable/Oxobiodegradable: Degradable /fragmentable in presence of oxygen. [Oxodegradable has been declassified as non biodegradable recently by UK’s department of food and environment2, EU bioplastics Council* and Nature magazine3]. (More clarification follows in the section below.)

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PACKAGING SPECIAL Photodegradable: Degradable into invisible pieces by action of the sun’s light and the sun’s heat.

Photodegradable mostly contains heavy metals as additives, which attains higher excitation state due to high energy levels and break the polymer chain.

But invisibles pieces remain in the environment.

Biodegradability: In 1992, an international workshop called Towards Common Ground - Meeting Summary of the International Workshop on Biodegradability, Annapolis, MD, US was organised to bring together experts from around the world to achieve areas of agreement on definitions, standards and testing methodologies. Participants came from manufacturers, legislative authorities, testing laboratories, environmentalists and standardisation organisations in Europe, US and Japan. Since this fruitful meeting, there is a general agreement concerning the following key points: ◗ For all practical purposes of applying a definition, material manufactured to be biodegradable must relate to a specific disposal pathway such as composting, sewage treatment, denitrification, or anaerobic sludge treatment. ◗ The rate of degradation of a material manufactured to be biodegradable has to be consistent with the disposal method and other components of the pathway into which it is introduced, such that accumulation is controlled. ◗ The ultimate end products of aerobic biodegradation of a material manufactured to be biodegradable are carbon dioxide, water and minerals and that the intermediate products include biomass and humic materials. ◗ Materials must biodegrade safely and not negatively impact on the disposal process or the use of the end product of the disposal.

Aerobic biodegradation: ◗ CPOLYMER + O2 → CO2 + H2O + CRESIDUE + CBIOMASS Anaerobic biodegradation: ◗ CPOLYMER → CO2 + CH4 + H2O + CRESIDUE + CBIOMASS Microbiological degradation can take place through the action of enzymes or by prod-

32 EXPRESS PHARMA April 16-30, 2015

THE ANAEROBIC MICROBIAL METABOLISM OF PRODUCTS SHIFTED WITH ECOPURE 1.Hydrolysis

2.Acidogenes

Sugars Carbonic acids and alcohols Resin treated with EcoPure

3.Acetogenesis

Fatty Acids H2 CO2 Ammonia Amino Acids

H2 Acetic Acid CO2

CH4 CO2

4. Methanogenesis Figure 1

ucts (such as acids and peroxides) secreted by microorganisms (bacteria, yeasts, fungi, etc). Also macro-organisms can eat and, sometimes, digest polymers and cause mechanical, chemical or enzymic ageing. It has been established that microbial biodegradation occurs mostly in two steps.

Occurrence of biodegradation Two key steps occur in the microbial polymer degradation process: first, a depolymerisation or chain cleavage step, and second, mineralisation.

The first step normally occurs outside the organism due to the size of the polymer chain and the insoluble nature of many of the polymers. Extracellular enzymes are responsible for this step, acting either endo (random cleavage on the internal linkages of the polymer chains) or exo (sequential cleavage on the terminal monomer units in the main chain).

Once sufficiently small size oligomeric or monomeric fragments are formed, they are transported into the cell where they are mineralised. At this stage the cell usually derives metabolic energy from the mineralisation process. The products of this process, apart from adenosine triphosphate (ATP), are gases, (e.g., CO2, CH4, N2,

H2), water, salts and minerals, and biomass.

Many variations of this general view of the biodegradation process can occur, depending on the polymer, the organisms, and the environment. Nevertheless, there will always be, at one stage or another, the involvement of enzymes. (For a detailed explanation kindly contact the author.)

Compostability and biodegradability: Compostability is biodegradability under controlled (read man made) conditions, in a specified time period. Aerobic degradation is the main form of degradation here.

Biodegradability is a wider term implying degradation in aerobic and/or anaerobic conditions anywhere, whether manmade or natural not necessarily bounded by time.

The practical aspects of the above two terms have wider implications.

Biodegradability occurs practically everywhere, especially in landfills, heavy sewage sludge conditions or any natural or man made conditions suitable for optimal microbial activity.

Microbes have used for decades to clean oil spills so why not plastics ( a derivative of petroleum ).

By the way, a sample of soil can contain depending on the location, at least 2000 genres of bac-

teria. In our country, India with limited land resources and no developed systems of disposal biodegradability, hence biodegradable plastics makes huge sense. Also our landfills are wet, which is more conducive to biodegradation. Landfills have anaerobic environment {except for the top layer}, which is suitable for anaerobic biodegradation. Evidences of newspaper/ cellulosic material being partially or practically non-degraded, even after two decades exists in the world (and can be found on Internet) so think how a bioplastics can degrade in a landfill!

Composting/industrial composting on the other hand requires industrial size compost facilities, where conditions have to be managed by man. [Composting here should not be confused with what we do with our kitchen waste at the back of the garden]. Hardly a few industrial composting exists (as defined by standards) in the US and Canada, where land is in ample supply.

Plastics biodegrade under two key steps: ◗ Long polymer chain cut at the carbon-carbon bonds – by heat, moisture, enzymes, or other conditions depending on the polymer. ◗ Shorter carbon chains pass

through the cell walls of the microbes and are used as energy source.

Biodegradation: When the carbon chains are used as food source and converted into water, biomass, CO2 or methane.

(Source: DuPont)

Comparison between different degradable plastics Bioplastics: Bioplastics are of two types. One made fully from plant based starch resources and other where starch/cellulosic content is used as fillers.

Applications: Mainly carry and compost bags.

Advantage (claimed): Ecofriendly as made from natural resources.

Disadvantages: Shelf life is six to nine months, change in manufacturing processes and machines. Bioplastics are at least three to five times more expensive than oxodegradable or biodegradable plastics.

PLA cannot withstand high heat.

PLA also takes 30 per cent more oil to produce than plastic itself. PLA requires 56 megajoules/kg of oil; PET requires 37 megajoules/kg of oil.

Degradation period: Six months to one year in aerobic conditions Degradation process: Microbial, aerobic

PACKAGING SPECIAL Reality: Bioplastics made of PLA (most prevalent) requires lots of corn for starch-based plastic. It’s weak and brittle and is said to impart off taste to food it carries. It is very expensive too.

One starch-based biodegradable plant was opened with much fanfare in Kashmir by the Chief Minister, but it shut down within a year, due to poor qualities of the products.

Diversion of food crop to make plastic is unsustainable. To illustrate an example if all of the disposable plastic products in the world were made out of corn, 150,000,000 tonne of corn would be used to make plastic. Prices for corn would rise dramatically, and third world hunger would increase even more dramatically.

There are currently 1,400,000,000 hungry people in the third world, says the UN. Photodegradable degrades only action of light, specifically sunlight. It is brittle and expensive and they can be only used in bags with short shelf life. It has already become unacceptable to the market, so further mention is irrelevant.

Biodegradable plastics: Made of petroleum derivatives with addition of additives.

Advantages: No change in manufacturing process, Shelf life — Unlimited Disadvantages: Using petroleum derivatives Applications: Bags, bottles, films, non woven pp bags, shoe soles, car body and white goods’ parts and many others.

Degradation: Aerobic and anaerobic degradation under ASTM 5338 and ASTM 5511-11 Degradation period: Nine months to three years depending on type and thickness of polymer Special mention-Plant bottle: Plant Bottle by Coca Cola is old wine a different bottle. It derives certain percentage of plastic/bottle from plant sources. Firstly it remains nondegradable as it is still a non degradable plastic product; secondly it is unsustainable as it derives the raw material from plants. What was the logic of creating it is beyond comprehension.

Oxo plastics are fragmetable (fragment into small invisible pieces by action of oxygen and sunlight ) , not degradable. It has

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been banned by EU Parliament.

Applications: Mostly LDPE Bags. Claims of usage in PET bottles have not been authenticated. [Our company, Vasudhaecofriends’ interactions with many FMCG and manufacturing companies reveal that they have not used oxodegradable for film and bottle applications after trials due to its low shelf life and film properties].

Advantages: Inexpensive.

Disadvantage: Shelf life of six months to one year and contains heavy metals.

Degradation period: Unverified for landfill.

Degradation: Oxidation through oxygen and sunlight.

Reality: Though used by many companies and countries in application such as shopping and garbage bags, oxodegradable

has been termed as non biodegradable by DEFRA, UK Government in 2010*. The same have been published by EU Bioplastics Council. Nature magazine published an online article on April 21, 2011 citing DEFRA report.

The DEFRA report mentioned, “These plastics should not be composted, as their breakdown fragments will ruin

the resulting compost. But neither can such materials be incorporated into traditional plastics recycling as the same additives that encourage the break-up of the original material will degrade the recycled material produced.”

It further added, “Both of these options make the ‘degradable’ property of oxo-degradable plastics irrelevant.” Noreen

PACKAGING SPECIAL

EcoPure is a range of organic copolymer additives, which accelerates the biodegradation* of traditional, oil-based plastic products in a biologically active landfill. When EcoPure is added at approximately one per cent during the manufacturing of many traditional plastic products, the product can biodegrade faster than untreated plastics when disposed of in microberich environments.

The addition of EcoPure does not negatively affect or require a change in the manufacturing process or the physical properties of the plastic application. For example, EcoPure treated PET water bottles will be just as durable, watertight, and have the same shelf life as an untreated PET bottle.

What makes EcoPure treated products revolutionary is their life after disposal, which becomes greatly reduced in a biologically active disposal environment. According to ASTM D5511-11/ISO 15985 test results, treated plastics take a fraction of the many years traditional plastics can take to biodegrade.

EcoPure additives are compatible with various types of plastics, including the following: PE, PET, PP, PS, Nylon, PVC, EVOH, ABS and Polycarbonate.

Biodegradation of plastics treated with Ecopure Microbial Quorum Sensing Microbes use quorum sensing to coordinate certain behaviours based on the local density of the bacterial population. Microbes that use quorum sensing constantly produce and secrete certain signaling molecules (called autoinducers or pheromones).

These microbes have a receptor that can specifically detect the signaling molecule (inducer).

When the inducer binds the receptor, it activates transcription of certain genes, including those for inducer synthesis.

As the microbial population grows the concentration of the inducer passes a threshold,

34 EXPRESS PHARMA April 16-30, 2015

10

SCORING

Vasudha’s biodegradable plastic

ECOPURE'S CURRENTVALUE CURVE 12

8 6 4 2 0

La nd fil lB io de gr ad ib ili ty & Go W vt M .C om pl Ap ia nc pl ic e ab le Sh to el fL Ty ife pe s of Pl as tic s Re c St yc la re bi ng lit th y & Fl ex ib ili ty He av y m Va et lu al e s & Cu st om Co er st Sa tis fa ct io n

Thomas, a materials researcher at Loughborough University, UK and one of the authors of the DEFRA report concluded, “There is no benefit to the environment of oxo-degradable plastics.”

Figure 2

FACTORS OF DIFFERENTATION

Ecopure

#The numbers are based on studies in different parts of the world and feedback for Ecopure from present and potential clients

causing more inducer to be synthesised. This forms a positive feedback loop, and the receptor becomes fully activated. Activation of the receptor induces the up regulation of other specific genes, causing all of the cells to begin transcription at approximately the same time. This coordinated behaviour of microbial cells can be useful in a variety of situations such as multiplying.

(Read more – http://en.wikip edia.org/wiki/Quorum_sensing) Biodegradation of Ecopure treated products is aerobic or anaerobic or a combination of both aerobic (with oxygen) and anaerobic (without oxygen). Microbes found in both conditions will be attracted to our biodegradable products and will colonise on the plastic, which will result in biodegradation. The stages of the complete process of anaerobic biodegradation (landfill conditions) with Ecopure products are listed below: It consists of four stages: ◗ Aerobic ◗ Anaerobic, Non-methanogenic ◗ Anaerobic, Methanogenic Unsteady Phase ◗ Anaerobic, and Methanogenic Steady Phase Figure 1 below shows the process:

Time period for biodegradation There are a number of factors which contribute to the length of time required to fully biodegrade. ◗ Type of plastic (i.e. LDPE, PET, and PS)

◗ Surface area of the product ◗ Mass and thickness of the plastic ◗ Microbial activity {which is further dependent on presence or absence of oxygen, temperature and pressure of the landfill/surrounding environment etc}.

For example a bottle with smooth surfaces will biodegrade slower than if the bottle had grooves. Generally thin films, bags will biodegrade in India’s wet landfill conditions within a year. The PET bottles, rigid plastics (HDPE, PP, ABS), multilayered plastics packaging will take a maximum of three years. Since ASTM 5511-11 methodology does not allow extrapolation of biodegradation, exact time to biodegrade cannot be estimated.

Nature and its elements have a big role to play, which cannot be predicted by human beings.

bial environments; suspended, dormant and active. Polymers treated with EcoPure require an active microbial environment in order to break down. In most environments such as warehouses, offices, store shelves the microbial environment is suspended or dormant and would not be considered an active microbial environment. So these treated product will have unlimited shelf life in warehouses and other dormant and/or suspended environment.

Standards and tests

Value vs cost of Ecopure

Ecopure is tested on ASTM 5338 (aerobic biodegradation by CIPET, Chennai on ASTM D 6400 Standard) ISO 14985/ASTM 5511-11 by Intertek, Mumbai ( anaerobic biodegradation), FDA, US and Food Grade, CIPET, Chennai (polyethylene migration tests on acetic acid and water). There are other third party labs across the world, which have tested different types of polymers.

(Log on to www.ecopure.in)

Pharma packaging, NGT and scientific evidence Ministry of Health notification on baning usage of PET in oral medicine has no long term research basis. European drug adminstration and US FDA5 have not foud any credible evidence of bisphenol or antimony poisoining in PET containers. FDA’s National Center for Toxicological Research (NCTR) have been studying BPA. The NCTR researchers have been conducting in-depth studies of BPA since September 2008, when a report by the

Shelf life There are three types of micro-

Recyclability Products treated with Ecopure are recyclable and reusable without any change in processes or machines. The recycled products (if not treated with Ecopure) would NOT degrade as optimum per cent of Ecopure in any product is required for biodegradation.

NIEHS and NTP called for more research into the potential toxic effects of BPA on fetuses, infants and children.

NCTR’s findings include: ◗ The level of BPA from food that could be passed from pregnant mothers to the foetus is so low that it could not be measured.

Researchers fed pregnant rodents 100 to 1,000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the foetus eight hours after the mother’s exposure. ◗ Exposure to BPA in human infants is from 84 to 92 per cent less than previously estimated.

NCTR mathematical models showed that BPA is rapidly metabolised and eliminated through faeces and urine. They found that BPA is ‘exactly the opposite’ from some other toxins, like dioxin, that can stay in the body’s tissues for months or even years.

The centre’s toxicology research has not found evidence of BPA toxicity at low doses in rodent studies, including doses that are still above human exposure levels.

The 65th meeting of Drugs Technical Advisory Board the basis of Ministry of Health’s notification itself admits to a lack of long term scientific study. If a scientific decision is to be made how come DTAB quotes ‘absence of evidence’ does not entail ‘evidence of absence.’ Just by quoting jargons and not looking into studies by governments and their agencies like US FDA, a point is not proven.

BPA is mostly found in polycarbonate bottles.

Leachates and extractables can be even found in glass, which is touted as an alternative, inorganic oxides and heavy metals are well known leachates from glass. This is the medical reason for not using glass. Besides temperature effects on leaching have not been studied wide and deep enough in India to prove otherwise for PET pharma packaging.

US FDA makes it clear that boiling liquid may result in leaching in any material including PET, in this particular case maximum temperature of 40-45 degree centigrade cannot become a benchmark for determination of toxicity.

PACKAGING SPECIAL A reputed Elsevier study in International Journal of Hygiene and Environmental Health [Volume 212, Issue 2, March 2009] points out that the highest estrogenic activity detected in water extracts was equivalent to the activity induced by 23.1 ng/L of the natural hormone 17ß-estradiol, which is non toxic. A white paper in International Life Sciences Institute6 on PET (2000) on general toxicity and genotoxicity studies on PET, its monomers and its typical intermediates indicate that it does not pose a threat to human health.

Sustainability, plastic waste management and legal framework in India In early 2011, the Ministry of Environment and Forests, Government of India came out with a framework of Plastics (waste) Management Notification after a panel of experts gave suggestions to it.

Firstly, does MoEF wish our young rag pickers to continue to pick up plastics in unhygenic and dangerous conditions?

Secondly, increasing thickness of bags will actually increase plastic waste in absolute volume in the landfill and in the environment ( through littering).

Thickness (of plastic products) is a dangerous precedent to consider. It does not give a full picture of waste.

Biodegradable plastics are an important part of the value chain of waste management.

Governments and the courts should be made more aware of these, their properties and advantages to society, so that they can take informed decisions Thirdly, why only certain type of usage has been picked for plastic ban? Why not all sachets or food packaging?

Fourthly, why not plan an integrated waste collection system across India, which has been endorsed through its intermediate judgement by the honourable Supreme Court, in a public interest litigation filed by Karuna society. [Unfortunately, NGOs have been doing a better marketing job than the plastic industry, that too without any rationale or scientific evidence.]

Lastly, the standards for biodegradation seems to have been just copy-pasted in the 2011 notification, by MoEF without even going into details. Lab conditions for biodegradation have been set as standards.

Biodegradable plastics have also been banned for food, without any scientific evidence.

States are going ahead and have started aping the MoEF on

thickness of plastics, specially bags. Under the Constitution of India not only the manufacturers and the government but citizens of India are ‘bound’ by article 51 A (g), which says: It shall be the duty of every citizens of India –g) to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures;Yet Government of India and state governments are not even trying to create the legislative and implementaion framework, let alone implement the fundamental duties of citizens.

In the view of the above, Government of India and the Supreme Court should consider the contribution of plastics and its packaging in our modern life and its impact on increasing efficiency and productivity in the complete value chain of industries and society as whole.

A single point suffices the importance of plastics in our lives.

More than 40 per cent of our food is wasted in India by GoI's own admission and various reports of Indian institute of Packaging, CFTRI, Mysore, ENVIS, TIFAC (996) and MS Swaminathan (Planning Commission 1981).

Central Pollution Control Board has supported biodegradable plastic packaging in early 2000’s in its report, yet MoEF failed to take cognisance.

Conclusion Biodegradable plastics are an important part of the value chain of waste management.

Governments and the courts should be made more aware of these, their properties and advantages to society, so that they can take informed decisions.

NGOs and public should also fully arm themselves with complete knowledge of different aspects of packaging and the value chain with different materials

and their carbon, water and energy footprints and impact on the environment and health of human beings and then act. The concept of 3Rs: Reduce, Reuse, Recycle would be highly beneficial for our country.

Likewise, packaging decisions should be based on real scientific studies and collaborating with institutes from other countries and independent sources, when labs like CIPET do not have the capability to do such studies. There is no proof of presence of toxic amounts of endocrine disruptors or carcinogen triggers in PET. The government and PET manufacturers should relook into this matter.

References 1) India Carbon Outlook : http://india.carbonoutlook.com/content/which-moresustainable-paper-or-plastic 2) DEFRA, UK January, 2010 http://randd.defra.gov.uk/Default.aspx?Menu=Menu&Module=More&Location=None&Com pleted=0&ProjectID=16263 & http://www.greenwashingspy.co m/?p=844 3) http://www.nature.com/ news/2011/110421/full/news.2011.

255.html 4) www.ecopure.in 5) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm2 97954.htm 6) http://www.ilsi.org/europe/ publications/r2000pac_mat1.pdf

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PACKAGING SPECIAL VALUE ADD

Malvern Instruments: An orthogonal approach to biopharmaceutical development Malvern Instruments in the article details the solutions provided for each step along the path of biopharmaceutical development, from discovery to quality control A NUMBER of unique properties make the development of effective protein therapeutics particularly challenging. An evolutionary trade-off between function and stability has led to most proteins being only slightly stable under ambient conditions, making storage problematic. Biotherapeutics tend to be administered directly into the blood stream, making it essential that impurities are removed or at least extensively characterised in order to minimise the potential of immunogenic reaction. The very process of injection itself has also been implicated as a cause of adverse patient reactions.

Discovery ‘The pharmacologic activity of protein products can be evaluated by…binding assays, and enzyme kinetics’ FDA Guidance for industry 2012 – Scientific considerations in demonstrating biosimilarity to a reference product Upon discovery of a potentially therapeutic molecule it is important to understand where the therapeutic properties come from in order to efficiently develop a high quality biopharmaceutical. For instance, the optimisation of the structure of the molecule in order to control the manner in which it binds to the target (a process known as lead optimisation) requires analysis of not only the affinity but also the mechanism of binding.

Through measurement of the Binding affinity (Ka), enthalpy change (ΔH), stoichiometry (n), and Gibbs free energy (ΔG) and entropy change (ΔS) of an interaction, Malvern’s

36 EXPRESS PHARMA April 16-30, 2015

Microcal range of isothermal titration calorimeters allow intelligent lead optimisation through elucidation of the binding mechanism (Figures 1 and 2). Interactions are studied in a biologically relevant environment by measuring a universal property common to all binding processes, making the Microcal iTC200 not only a highly effective drug discovery tool, but also an ideal means of demonstrating comparability or batch quality.

Formulation and stability ‘Excipients should be evaluated for their potential to prevent denaturation and degradation of therapeutic protein products during storage’ ‘Some antibodies generated by aggregates containing native protein can inhibit or neutralize product activity. In contrast, some antibodies to denatured/ degraded protein…cause anaphylaxis, but do not inhibit or neutralise activity of the native protein’ FDA guidance for industry 2014 – Immunogenicity assessment for therapeutic protein products After discovery and lead optimisation begins the formulation process, with preformulation screening allowing the detection of any potential barriers that may crop up during the development of a lead candidate, minimising the risk of developing a drug that cannot be successfully marketed.

As a screening step, preformulation requires automatable analysis. The Malvern Viscosizer 200 allows automated viscosity

Figure 1: The Malvern Microcal iTC200; an automatable low volume isothermal titration calorimeter for highly sensitive label-free study of biomolecular interactions

Figure 2: Typical ITC data; raw data showing difference in power supplied to the 2 heaters vs time (left); Integrated heat change per injection with best curve fitting (right).

The Malvern Viscosizer 200 allows automated viscosity analysis of formulations with protein concentrations up to and above 300 mg/ml

analysis of formulations with protein concentrations up to and above 300 mg/ml. Viscosity is calculated as a function of the speed of a sample moving through a microcapillary (similar in diameter to a hypodermic needle), measured using two spectrophotometric detection windows. Viscosity data from the Viscosizer 200 is used to establish injectability and processability; if the viscosity of a formulation is too high for it to be injected into a patient, it must either be developed further or dropped – however, stable the formulation is. Likewise, however, an easily injectable biopharmaceutical with low stability is also of limited marketability, and the same dual-detection set-up that allows viscosity analysis also allows monitoring of size by taylor dispersion analysis (TDA).

As an absorbance-based method, TDA can be used to assess protein in complex formulations. The Viscosizer 200 therefore gives a truly orthogonal means of formulation analysis.

The gold standard for formulation stability screening is differential scanning calorimetry (DSC). DSC is easily automatable, requires no sample modification and measures thermodynamic change – a universal property common to all protein conformational changes. Malvern’s Microcal VP-Capillary DSC system performs comprehensive stability characterisation for 50-plus samples per day, with use of a tantalum cell eliminating interactions between the formulation and the cell and maximising the signal-to-noise ratio. Malvern’s

PACKAGING SPECIAL

Figure 3: Typical Microcal VP-Capillary DSC data; high through put measurement and data analysis allows efficient formulation stability screening

Microcal DSC range gives an ideal means of stability-based formulation screening, allowing efficient development of stable formulations (Figure 3).

The necessity of understanding the causes of them is underlined by the increasing implementation of quality by design (QbD) precepts throughout the industry. With QbD in mind, Malvern has combined dynamic light scattering (DLS) and Raman Spectroscopy, giving a comprehensive assessment of both aggregation and conformational changes in a single instrument – Zetasizer Helix.

Since both measurement types are performed in an interleaved manner on the same sample, the instrument is ideal for performing kinetics measurements (Figure 4). Detailed spectra allow analysis of tertiary structure and quantification of secondary structure changes. The light scattering function, in addition to aggregation analysis also allows stability prediction through measurement of virial coefficients and zeta potential. Zetasizer Helix provides a comprehensive understanding of the causes of biopharmaceutical instability, allowing intelligent formulation design and increasing the quality and efficiency of biotherapeutic development.

Sub-visible particles ‘Subvisible particulates in the size range of 0.1–10 microns

Figure 4: Kinetic assessment of the effect of formulation using the Zetasizer Helix; Incubation at 60 °C leads to aggregation at both pH 5.4 and 7.1 (left, DLS data), though loss of structure is only observed at pH 7.1 (right, Raman spectroscopy data). Native aggregates are formed at pH 5.4 therefore, whilst incubation at pH 7.1 leads to the formation of denatured aggregates.

Figure 5: IgG aggregation as monitored by Malvern NanoSight NTA; the development of subvisible particles is monitored over time, with individual particles visualised through the light they scatter

have a strong potential to be immunogenic’ ‘All therapeutic protein products should be evaluated for their content of…proteins and nonprotein components’ FDA Guidance for Industry 2014 – Immunogenicity Assessment for Therapeutic Protein Products Subvisible particles (generally defined as being from 0.1 – 10 μm in size) are currently the subject of much regulatory scrutiny. Since immunogenicity is dependent not only on particle size, but also on morphology, composition and concentration, regulatory authorities are increasingly advocating an orthogonal analytical approach to char-

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Malvern’s Microcal DSC range gives an ideal means of stability-based formulation screening, allowing efficient development of stable formulations

Figure 6: Protein aggregate particles and silicone oil droplets (top) differentiated using Archimedes RMM (bottom); in aqueous formulations silicon particles increase, and protein particles decrease, the frequency of cantilever resonance as they flow through the system

Figure 7: Morphologi G3-ID; combining automated static imaging with chemical identification of individual particles using Raman spectroscopy

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PACKAGING SPECIAL NanoSight Nanoparticle Tracking Analysis (NTA) uses an advanced video camera to track and size subvisible particles individually but simultaneously using their light scattering signal.

Hydrodynamic size is calculated from the Brownian diffusion speed of the particles, with resolution of individual particles allowing concentration calculation acterising subvisible particles.

NanoSight Nanoparticle Tracking Analysis (NTA) uses an advanced video camera to track and size subvisible particles individually but simultaneously using their light scattering signal (Figure 5).

Hydrodynamic size is calculated from the Brownian diffusion speed of the particles, with resolution of individual particles allowing concentration calculation. Measurement of the scattering intensity of each particle allows differentiation of particles of different compositions in complex mixtures. The particles can also be tracked using their fluorescence signal, with fluorescence presenting another means of compositional differentiation. The ability to monitor individual particles allows the generation of high resolution size profiles without fractionation, whilst visual validation gives confidence in any process optimisation that such data may inspire.

Archimedes Resonant Mass Measurement (RMM) also presents a means of accurately measuring subvisible particle concentration and size, as well as differentiating between different materials.

Sample flows through a cantilever resonating with a specific frequency, with particles causing a change in the resonant frequency based on their buoyant mass. Size can be calculated from the magnitude of the change in frequency, with concentration being directly measured from the number of such frequency changes. Particles are identified based on their density, with the differentiation of subvisible protein aggregates and silicon droplets in pre-filled syringes being an ex-

38 EXPRESS PHARMA April 16-30, 2015

cellent example of the power of Archimedes (Figure 6).

The importance of morphology to particle immunogenicity is becoming increasingly understood as the options for analysing this parameter improve. Microscopy can be used to assess the morphology of sub-visible and visible particles, though automation is essential for such characterisation to be performed efficiently and without operator bias. The Morphologi G3-ID system (Figure 7) allows a range of morphological parameters to be assessed in a hands-off manner using static image analysis, with both the collection and analysis of data being completely automated.

The Morphologi G3-ID also comes fitted with a Raman spectroscope, with the capability of acquiring Raman spectra of individual particles. Comparison with a robust spectral library (incorporated within the Morphologi G3-ID software) containing Raman spectra of common biopharmaceutical contaminants such as silicon, cellulose and rubber, allows unequivocal chemical identification of each particle measured.

Quality control and comparability ‘Methods that individually or in combination enhance detection of protein aggregates should be employed to characterise distinct species of aggregates in a product’ FDA Guidance for industry 2014 – Immunogenicity assessment for therapeutic protein products The problem of proving quality or comparability re-

quires a simple, robust and highly sensitive solution.

Since protein aggregates and other large particles are possibly immunogenic, and that in many cases protein’s aggregate upon loss of function, sensitive analysis of aggregates and impurities gives an excellent means of assessing quality. Since larger molecules scatter more light than smaller molecules, light scattering methods are an ideal means of performing such analysis.

Size exclusion chromatography (SEC), such as that performed by Malvern’s Viscotek systems, allows high-resolution aggregate analysis by separating monomer and small oligomers (dimer, trimer etc.), with the use of light scattering detectors to analyse the eluent giving the best chance of detecting such aggregates. Malvern’s SECMALS 20 multi angle light scattering detector uses 20 light scattering detectors arranged around a vertical flow cell to calculate absolute molecular weight without the need for column calibration (Figure 8). In addition to working in conjunction with Malvern’s Viscotek SEC systems, the MALS 20 detector is also compatible with third party SEC systems. The simplicity and high resolution of SEC explains why its use is advocated for aggregate analysis in ICH Topic Q6B. Dynamic light scattering (DLS) measurements performed using Malvern Zetasizer systems give a highly sensitive means of assessing aggregates and impurities without fractionation. Al-

Figure 8: Typical protein SEC-MALS 20 data; multi-angle detection allows accurate Mw calculation for all molecules, from monomers to large aggregates, resolved during biotherapeutic SEC analysis

Figure 9: Zetasizer APS aspirates 20 μl sample from industry standard well plates into a Peltier controlled quartz flow cell, allowing automated generation of high quality size data

though, relative to SEC, DLS is a low resolution technique, the simple cuvette-based nature of a Zetasizer measurement explains the wide usage of the instrument alongside SEC-MALS as an orthogonal biopharmaceutical characterisation strategy.

The Malvern Zetasizer range allows sizing over a very wide range (from 0.0003 – 10 μm), and includes the APS system (Figure 9), an automated plate sampler capable of performing efficient QC and comparability analysis on large numbers of samples.

Orthogonal characterisation from discovery to batch release Though biopharmaceuticals have obvious advantages over chemically synthesised drugs, including high potency and fewer side effects, protein therapeutic development involves a number of novel problems.

Malvern Instruments provides a solution for every stage of the biopharma development process, from lead optimisation and formulation development to proof of quality and comparability.

PHARMA ALLY I N T E R V I E W

‘We believe in creating innovative solutions for a variety of industries’ Sudarshan Ananth, Territory Vice President and Business Head – HVAC & Transport, India Climate Business Unit, Ingersoll Rand, talks about new launches from brand, Trane India and their benefits for the pharma industry, in discussion with Sachin Jagdale Which products have been launched under Trane brand?

Trane is a leading global provider of indoor comfort systems and solutions (HVAC systems, controls and services) for commercial, residential and industrial applications and a brand of Ingersoll Rand.

Trane’s integrated solutions help reduce energy use and costs while meeting high levels of comfort and performance critical to business operations of its customers.

Trane has recently announced new products in applied and unitary stream.

The new range of products is more energy proficient, raising the bar for efficiency, cost optimisation, sustainability and reliability along with showcasing Trane’s strength.

ideal choice for application for a wide spectrum of building such as industrial plants, commercial/office buildings, hospitals, hotel and schools.

Trane water-cooled screw chiller with AFD (RTHD): This best in class chiller offers part-load energy efficiency and reduces annual operating and lifecycle costs .Compared with fixed speed chiller designs, the RTHD with AFD offers a part-load efficiency improvement of 2035 per cent while maintaining the same COP efficiency level.

This will typically result in an annualised energy saving of 10-15 per cent in chiller energy consumption.

The industrial-grade design of the helical rotary chiller and its versatile operation capability make it an

Interactive Hi wall series and Concealed units R410: The environment-friendly Trane Interactive products are aimed at providing high degree of convenience, comfort and control that one always needs and make everyday living simple and intuitive.

Some of the revolutionary features of the Trane Interactive Technology are: ◗ Multi Room Control Control up to 18 Trane ACs and a door lock, from anywhere in the house through multi-room mode on the remote. You can switch on/off, change temperature or fan

Trane air cooled screw chiller Sintesis (RTAF): Sintesis is born out of Trane commitment to energy efficiency. This air cooled screw chiller comes with three different types of efficiency level chillers with the highest EER up to 3.4 and ESEER up to 4.8. Trane has focused on providing sound levels at the lowest level with an extra low noise. Trane AFD fitted on this chiller provides an excellent part load efficiency resulting on a low total cost of ownership. The chiller comes with superior energy efficiency at a low noise level and it is smart and versatile with the highest reliability in the industry.

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The environmentfriendly Trane Interactive products are aimed at providing high degree of convenience, comfort and control that one always needs and make everyday living simple and intuitive

speed of any Trane AC in any room of your home. ◗ Efficiency meter - The efficiency meter on the remote enables you to keep real time control of your Trane ACs energy consumption by helping you in choosing the right set point based on the weather outside ◗ Trane weather sync mode Trane Weather Sync mode syncs the operations of the AC with the weather outside and automatically adjusts the temperature inside to give you optimum comfort. ◗ No pointing - The Trane Interactive technology allows you to control Interactive ACs without having to point remote towards them. ◗ Service alerts - The interactive remote displays easy to understand service alerts which are clear, crisp and actionable. ◗ R410 – Environment friendly and efficient refrigerant.

Explain the application of these products in the pharma industry.

Energy efficiency is a key cost driver in the pharma / healthcare industry and HVAC companies offer a variety of technology solutions HVAC systems to increase energy efficiency during partial load.

We at Ingersoll Rand believe in creating innovative solutions for a variety of industries. We bring the expertise to pharma and healthcare with solutions that are reliable and sustainable in the areas of compressed air systems, tools, security

technologies, HVAC systems and mobile/static refrigeration. Our constant focus is on establishing comfortable and efficient pharma and healthcare environments.

Some specific examples of requirement in healthcarerelated industries today include quality of compressed air, energy efficient building management systems, FDA compliant climate control systems, safety and security of facility/ equipment and safe transportation of temperature controlled drugs. Ingersoll Rand offers a solution to each of these requirement. Trane as an organisation is providing retrofit options for existing chillers to achieve part load efficiencies with a variable speed drive. Our solutions of auto tube cleaning for water quality stressed environment and high efficiency air cooled central plant makes it optimum for capital and operational utilisation.

There are various HVAC requirements in the pharma industry, the two major requirements of the pharma industry are maintaining the temperature and maintaining the humidity.

Trane provides HVAC systems like chillers, air handling units and the allied controls that is used to manage the pharma manufacturing environment Trane provides chillers that are energy efficient during full load and part load conditions and as well support in partial and full heat recovery where

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PHARMA ALLY humidity need to be managed Trane chiller plant manager and the other controls offerings help the pharma industry to maintain precise control over the manufacturing environment.

Trane provides solutions for all the manufacturing environments like drug formulations, packaging, filling etc.

Who are your pharma clients in India?

Our chillers are contributing to almost all major pharma companies in maintaining their manufacturing environment.

Major pharma companies like DRL, Ranbaxy, Cipla and Glenmark are some of our key customers.

What percentage of your revenue comes from the pharma business?

Around 15 per cent of our

chiller revenues are contributed by the pharma and life sciences vertical and the industry is growing at a CAGR of eight per cent.

Which are going to be the driving factors for your pharma business in India in future?

Healthcare for all is a focus area for both central and state governments both in India and other developed nations like US. This industry has direct bearing on growth of pharma and hospital sector. The pharma industry is expected to touch $55 billion by 2020 from the $12 billion levels in 2013 and with 60-70 per cent of revenues coming from the exports. Indian pharma manufacturing facilities registered with US Food and Drug Administration (FDA) as on March 2014 was the highest at 523 for any country outside the US.

With the pharma sector poised to grow, especially with the state government providing appropriate infrastructure for growth, we feel there is a huge opportunity for HVAC players

Hence, with the pharma sector poised to grow, especially with the state government providing appropriate infrastructure for growth, we feel there is a huge opportunity for HVAC players to look at newer playing fields.

Safe delivery of drug is paramount to realise the benefit for the producer and user. Hence, controlled air environment is necessary for temperature-controlled transportation of pharma products from source/ manufacturing facility to storage or distribution, and within manufacturing facility both for temperature-sensitive raw material and intermediate or finished product.

The localisation push will necessitate a capacity expansion in the industry and in turn will help growing usage of HVAC. Identification of new export

markets and opportunities for Indian companies in china will also lead to capacity expansion in the industry.

Which are the new products in the pipeline for the pharma industry?

We have launched two new products this year. We are planning to launch our Ecowise products very soon.

Ecowise comes up with R513a refrigerant which has lesser ODP than most of the current available refrigerants used in the chiller.

We are planning to launch our Air Fi controller offerings which has wireless controllers with best in class technology.

Apart from this, our new modular chiller with VFD technology will be launched this year, which can be used for both process as well comfort applications sachin.jagdale@expressindia.com

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PHARMA ALLY VENDOR NEWS

Chiltern ranks among top CROs in global survey of clinical research sites The CenterWatch survey conducted between October 2014 and January 2015 measured 38 attributes of CRO-site relations from study planning to innovation CHILTERN, A leading global CRO, has ranked third among all CROs in the 2015 CenterWatch survey of 1,900 global investigative sites. The CenterWatch survey conducted between October 2014 and January 2015 measured 38 attributes of CRO-site relations from study planning to innovation. Respondents from investigators and study coordinators, 75 per cent of them from North America and Europe, rated Chiltern in the top three for 27 of those attributes. The 2015 survey demonstrates marked improvement for CRO effectiveness overall com-

Respondents from investigators and study coordinators, 75 per cent of them from North America and Europe, rated Chiltern in the top three for 27 of those attributes pared the prior survey two years ago.

On Chiltern’s high ranking, Susan Romberg, Vice President, Global Clinical Development noted, “Chiltern sees the benefits of specialisation through having a deep under-

standing of the patient experience and appreciation for challenging site logistics. This is why we invest in building strong partnerships with site coordinators and investigators.”

Romberg went on to note

the impact of internal efforts also: “Chiltern’s transparent culture, career development planning for both technical and soft skills, empowered leadership at all levels and a positive, supportive work environment all contribute to

employee retention that exceeds industry averages for improved site relations.”

“We’ve seen growing value in relationship-building among all parties in the clinical development process and site alliances are a significant part of that,” commented Chiltern Chief Operating Officer, Aize Smink. “I’m proud of our teams for this recognition to make site relationships a core focus, we could not be successful without the support of all our investigators and their staff globally.”

EP News Bureau-Mumbai

SCHOTT trains more than 3,000 professionals at its FIOLAXAcademy The modular training programme has been designed in six parts where experts share the latest industry information on the use of glass in pharma ampoule, vial, cartridge and syringe manufacturing SCHOTT HAS reached the landmark of training more than 3,000 professionals at its FIOLAX Academy. Started in 2010, FIOLAX Academy events share the latest information on the composition, properties and production of high quality pharma glass.

Participants have come from within specialist companies that are converting glass tubes to primary glass packaging, and from pharma businesses. The academy takes its name from SCHOTT FIOLAX glass tubing, which has grown to become the

gold standard ‘raw material’ for glass containers in the pharma industry. SCHOTT hosts FIOLAX Academy events in many of the world’s leading and emerging pharma markets.

Since 2010, there have been more than 150 FIOLAX Academies in countries throughout the world, from Europe and the US to South and Central America, India, Japan, and China.

There have been 15 such events with 530 participants in India.

Through its academy in India, SCHOTT Glass continues to offer opportunities to leading

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pharma companies to learn more about the benefits of using primary pharma packaging made of high quality glass.

“SCHOTT India is dedicated to maintain highest quality standards in glass tubing for primary packaging and to overall promote best practices in the pharmacy sector. With such encouraging participation in these specialised programmes, we are further motivated to conduct more of such events,” said Sundeep Prabhu, Vice PresidentSales and Marketing, SCHOTT Glass India.

Dr Bettine Boltres, Product Manager Pharmaceutical Tubing and responsible for this training programme, explains, “At SCHOTT we are thrilled to have already trained so many people in the FIOLAX Academy.

We are continually expanding the programme to offer a complete training experience, covering topics such as drug-container interactions, regulatory requirements and glass quality.

Through these training events we help our partners to improve quality and to increase efficiency and in turn advance their

position in both their domestic and international markets.”

The FIOLAX Academy modular training programme has been designed in six parts.

SCHOTT experts share the latest industry information on the use of glass in pharmaceutical ampoule, vial, cartridge and syringe manufacturing. Specialist insight is also provided for drug makers and contract fillers about the handling of glass during the filling processes to help decrease the risk of breakages.

EP News Bureau-Mumbai

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PHARMA ALLY

Quintiles and Quest Diagnostics to form JV The partnership will provide global clinical trials laboratory services QUINTILES AND Quest Diagnostics recently announced a definitive agreement to form a global clinical trials laboratory services business. By combining the clinical trials laboratory operations of two industry leaders, the new entity will provide customers with the depth of capabilities and end-to-end clinical trial laboratory services required to succeed in the increasingly complex biopharmaceutical industry. The new entity will offer a compelling value proposition to solidify its position as the second-largest central laboratory services company in the world.

The joint venture would have generated approximately $575 million in revenues in 2014, and will offer a superior breadth of services and an industry-leading test menu to its customers across all segments of the biopharmaceutical industry – a group that includes all of the top-20 largest biopharmaceutical companies. Upon closing of the transaction, Quintiles will own 60 per cent and Quest Diagnostics will own 40 per cent of the new joint venture.

Quintiles’ scale, clinical trial expertise, and diverse therapeutic experience coupled with Quest Diagnostics’ operational, scientific and quality excellence, supply chain network and informatics promise greater in-

42 EXPRESS PHARMA April 16-30, 2015

The new entity also will leverage a number of additional resources from the broader Quintiles and Quest Diagnostics organisations, including the award-winning Quintiles Infosario technology platform and Quest Diagnostics’ robust data analytics capabilities novation, quality and value for biopharmaceutical customers.

In addition, customers will benefit from a globally scaled and agile business model that is singularly focused on delivering top-quality laboratory services informed by deep medical and clinical knowledge.

Clinical, scientific and statistical excellence is becoming increasingly important for successful laboratory work as part of the regulatory approval process. To meet these needs, the entity will draw upon the deep scientific, medical and data expertise of Quintiles and Quest Diagnostics, which together have a team of approximately 3,500 medical doctors, Ph.D.s and biostatisticians as well as cutting-edge experience, expertise and capabilities in the areas of genomics and precision medicine.

The new entity also will leverage a number of additional

resources from the broader Quintiles and Quest Diagnostics organisations, including the award-winning Quintiles Infosario technology platform and Quest Diagnostics’ robust data analytics capabilities. Both companies are bioinformatics leaders in their respective fields – positions that have been built upon and honed from diverse experience and data access.

Quest Diagnostics draws from 20 billion test results, and Quintiles’ assets include electronic health records representing more than 60 million patient lives and a network of 250,000 clinical investigators.

“This joint venture builds upon the best of Quintiles’ and Quest Diagnostics’ strengths, creating top-quality services for customers,” said Tom Pike, Chief Executive Officer, Quintiles. “It will join together the scale, expertise and end-to-end capabilities of the broader

Quintiles and Quest Diagnostics organisations with a laserlike focus on providing worldclass laboratory services that will help improve customers’ probability of success. Quintiles and Quest Diagnostics are already industry leaders with complementary offerings, capabilities and visions to improve patient outcomes and human health. We’re excited about the opportunities ahead of us and the benefits we can provide customers.”

The joint venture will be led by an experienced global management team appointed from Quintiles and Quest Diagnostics. Built upon the strong histories and foundations of quality delivery of its parent organisations, the new entity will provide customers with a variety of advanced testing capabilities and services. These will enable end-to-end companion diagnostic development

with regulatory, reimbursement and commercial strategies, to help biopharmaceutical customers’ precision medicine efforts. It also will help enhance quality and efficiency by leveraging Quest Diagnostics’ supply chain that serves approximately half of the physicians and hospitals in the US and includes 2,200 service centres, 3,000 couriers and connectivity solutions used by 250,000 healthcare providers.

“We’re thrilled to partner with the world’s leading biopharmaceutical services provider to help customers succeed with their clinical trials and support the pursuit of precision medicine,” said Steve Rusckowski, Chief Executive Officer, Quest Diagnostics.

Beyond the immediate opportunity in laboratory services support for clinical trials, Quintiles and Quest Diagnostics expect to benefit from opportunities to collaborate in other areas. These include new ways to enhance patient recruiting and retention for clinical trials; speed the validation, development and commercialisation of companion diagnostics; enhance support of real-world late phase studies; and develop new population-health analytics and tools.

EP News Bureau-Mumbai

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In order to assess these effects we need suitable analytical solutions: Malvern Microcal DSC Measures stability of 40 + formulations per day.

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ABLE elects new office bearers To focus on improved strategies to catapult the industry to new heights THE EXECUTIVE council of the Association of Biotechnology Led Enterprises (ABLE) has elected Dr Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon as its first non-executive chairman in an honorary capacity.

Dr P M Murali, Managing Director and Chief Executive Officer, Evolva Biotech has been re-elected as President for a second term. Shrikumar Suryanarayan, Chairman, Sea6 Energy has been elected as the Vice President and Dr Goutam Das, the Chief Operating Officer, ABLE has been elected as the secretary and

will also hold the treasurer portfolio. The new office bearers will serve in their new positions for a period of three years from 2015 to 2018.

The new office bearers will focus on addressing industry view points on Indian bio-diversity, to try to bring about a conducive climate for the growth of synthetic biology for industrial, pharmaceutical and agricultural applications, on addressing issues connected with experimental animals, to prepare a consultative draft policy paper on bio-similars regulations and to bring out a white paper on

Biotech industry has the potential to grow to contribute to the national overall GDP Foreign Investment Promotion Board.

Biotech industry has the potential to grow to con-

tribute to the national overall GDP and ABLE has been playing the interface between the industry, academia, investors and the various government organisations at the state and central levels. These initiatives are aimed towards meaningful interactions with ministries in the government and act as a good guiding principle for a number of Biotech initiatives that the government is planning.

The high demand for different biotech products has also opened up scope for the foreign companies to set up base here. Positive messaging

and initiatives will automatically improve the investment scenario in the country which in turn will boost the growth of the sector. The biotechnology sector in India has been witnessing accelerated growth in the past and is now attaining critical mass in terms of skills and capabilities to become a truly global player after a decade of lull.

The Indian biotech industry holds about two per cent share of the global biotech industry which needs to grow to double digits.

EP News Bureau-Mumbai

AWARD

WHO India honours public health champions Event held jointly with MoHFW to commemorate World Health Day AT A national consultation held recently in New Delhi jointly with the Ministry of Health & Family Welfare (MoHFW), Government of India (GoI) to commemorate the World Health Day 2015, the WHO Country Office for India gave out awards for Public Health Champions.

The award winners were: SEWA Rural; Community Health Department, Christian Medical College, Vellore; Biocon Foundation and Dr Vinod K Paul, AIIMS, New Delhi for sustained contribution to public health. In the category of innovation, the awardees were Narayana Health and Ekjut.

Present on the occasion were: Bhanu Pratap Sharma, Secretary (Health & Family Welfare), GoI and Chairperson, Food Safety and Standards As-

64 EXPRESS PHARMA April 16-30, 2015

The rationale for recognising public health champions is to honour efforts of both, individual(s) and institution(s) who have made an outstanding contribution to public health through advocacy for and involvement in impactful health policies sociation of India (FSSAI); Keshav Desiraju, Secretary, Department of Consumer Affairs, GoI; Dr Jagdish Prasad, Director General Health Services, MoHFW; Anshu Prakash, Joint Secretary, MoHFW; Sudhanshu Pandey, Joint Secretary, Ministry of Commerce; YS Malik, Chief Executive Officer, FSSAI, MoHFW; and Dr S Venkatesh, Director, National

Centre of Disease Control (NCDC), MoHFW, amongst other eminent academic, technical, research and industry experts, non-governmental and civil society organisations.

Highlighting the importance of the public health champions awards, Dr Nata Menabde, WHO Representative to India said, "Public health is a challenging field and

these awards are our way of saying thank you to the talented individuals and organisations that have dedicated themselves to this field. These awards are an attempt to recognise and honour the best in this field and also to encourage others to emulate them."

The rationale for recognising public health champions is to honour efforts of both, indi-

vidual(s) and institution(s) who have made an outstanding contribution to public health through advocacy for and involvement in impactful health policies and programmes with proven public health achievements and substantial improvement in equitable health outcomes in the country.

The awards comprise two categories: sustained contribution to the field of public health, and innovation. The scope of the awards covers contributions to significant advances in population and person focused services and inter-sectoral actions. In addition, contributions that have assisted WHO in performing any one of its six core functions were taken into consideration.

EP News Bureau-Mumbai

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.