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Contents

E|X|P|R|E|S|S

Pharma VOL 7. NO. 20 AUGUST 16-31, 2012 Chairman of the Board

quotes

Viveck Goenka Editor

The Indian guidelines make no mention of data exclusivity but that does not mean that there is no protection of intellectual property

Viveka Roychowdhury* Photo Editor Sandeep Patil BUREAUS

William Lee Head of Regulatory Strategy Quintiles Asia

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore

Page 15

Neelam M Kachhap Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty

The move to allow FDI is a positive one as there is a need to provide impetus to R&D and creating an attractive proposition for global pharma players will allow companies to do just that

Commerce Ministry to discuss issues on non-tariff barriers... In a move to promote Indian pharmaceutical industry, Anand Sharma, Union Minister of Commerce and Industry, Government of India, at a recently held meeting on Consultative Group on Exports of Pharmaceutical Products, discussed issues related to the non-tariff barriers imposed by the US and EU against Indian companies

Senior Manager Rajesh Bhatkal

Page 22

S Ramesh President Finance and Planning Lupin

PRODUCTION General Manager B R Tipnis

Sanofi Pasteur’s dengue vaccine demonstrates proof of efficacy

Page 34

Production Manager Bhadresh Valia Asst. Manager - Scheduling & Coordination

Water and air are the two most critical utilities for pharma industry and water is often seen as the biggest raw material as well. Thus all pharma industries are highly concerned for water quality across all applications in their consumptions

Arvind Mane Asst. Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma C I R C U L AT I O N

Page 46

Amit Doshi Director, High Purity Water and International Operation Doshion Veolia Water Solutions

Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2010-12 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 & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021)

interview

Sanofi Pasteur, the vaccines division of Sanofi, has announced that its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, a threat to almost three billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety Page 40

Reproduction in any manner, electronic or otherwise, in whole

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or in part, without prior written permission is prohibited.

August 16-31, 2012

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Editor’s Note

Testing the barometer for biosimilars ith the London 2012 Olympics just behind us, we don't need to be reminded that being first

counts. So when Celltrion got approval for Remsima, its copy of Johnson & Johnson's Remicade (infliximab) the South Korean company lost no time in proclaiming Remsima as the world's first

official biosimilar antibody to get approved. Remicade is considered a regulatory milestone in the biologics world, because it was one of the first monoclonal antibody (MAb) TNF inhibitors approved for the treatment of rheumatoid arthritis. But is Remsima really the world's first MAb? Didn't Dr Reddy's Laboratory (DRL) get approval from the Indian authorities for Reditux way back in 2007, a full five years before Celltrion's Remsima? As DRL's brand of rituximab, a MAb used in the treatment of Non-Hodgkin’s Lymphoma, Reditux was launched in April 2007 in India and created quite a stir, both within the country as well as abroad. It turns out that yes, Celltrion can claim that Remsima is the world's first official biosimilar antibody, with the operative word being 'official'. At the time Reditux was up for approval, the European Medical Agency (EMA) was the sole global regulator to have released guidelines for biosimilars, which it had released in 2005. In 2007, India, like most countries, did not have a separate approval process for biosimilars so Reditux was approved using an abbreviated version of the pathway for small molecule generics, with the regulatory bodies in India weighing the merits of each applicant on a case to case basis. Reditux was launched at half the price of the originator and it looks like the regulators in India decided that any affordable treatment was better than no treatment at all. By the time Celltrion's Remsima, came up for approval five years later, the Korean Food and Drug Administration had in place a biosimilar pathway based on globally accepted guidelines like the EMA and WHO. Thus Celltrion can claim that Remsima is the world's first official biosimilar Mab. Come September, India's biosimilar guidelines will be in place and this time, they too are modelled on global norms. But this is just a first step, as our cover story, ‘Gearing up for the biosimilar boom’, points out. Across borders and jurisdictions, global regulators are not satisfied with their own regulations for biosimilars and are constantly debating further changes to keep pace with technology and clinical evidence. At best, everyone (somewhat) agrees that the WHO definition of biosimilars is on track. But that is possibly the only point of consensus. While the current philosophy might be to focus on proving similarity, the question being debated is to what degree must the biosimilar be similar to the originator? And how much clinical trial data is required to judge safety and efficacy of the biosimilar? How much should the guidelines control the manufacturing process itself since even small, seemingly insignificant variations in the manufacturing or storage process could impact clinical results? While originators are naturally pushing for high benchmarks to scare off competition, governments and regulators are aware that biosimilars are key to keep healthcare costs down. Estimates are that seven of the top 10 drugs prescribed in the US, the world’s biggest market for biosimilars, will be biologics and while this spells opportunity for biosimilar manufacturers, it also means that regulators will have to be sure that they have a fool proof system in place to test biosimilars. The regulators in India were right to postpone the implementation date by a month in order to get feedback from the industry. Before we ride the biosimilars boom, regulators the world over will have to ensure that the guidelines governing biosimilars go a step further than the Olympic motto: "Faster, Higher, Stronger” adding SAFER to this credo. Viveka Roychowdhury viveka.r@expressindia.com

10 EXPRESS PHARMA

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THE BUSINESS OF PHARMACEUTICALS

UPFRONT DCGI asks CDSCO’s offices to ensure implementation of ban on serodiagnostic test kits Usha Sharma Mumbai

Q1 results registers ups and downs in Indian pharma sector Indian pharma companies have recently released Q1 results, Express Pharma highlights the Q1 performance

Page 24

ost the ban on serodiagnostic test kits, the Drug Controller General (India) (DCGI) has requested zonal, sub zonal, port offices of Central Drugs Standard Control Organisation (CDSCO), to follow up with State Drugs Controllers on its effective implementation. The DCGI has circulated the letter to all State Drugs Controllers to stop the use of serodiagnostic test kits for diagnosing tuberculosis (TB). The letter issued by Dr GN Singh, DCGI mentions, “You are requested to ensure that the licenses granted in your state for the manufacture of serodiagnostic test kits for diagnosis of tuberculosis' are cancelled with immediate effect and arrangement has been made to recall the kits from the market on a priority basis. Chemists, druggists and manufacturers in your state should also be directed to stop the manufacture, import, sale, distribution and use of these kits with immediate effect and return the unused stocks to the manufacturers.” Dr Hemant Koshia, Commissioner, Gujarat Food and Drug Control Administration (FDCA) said, “Today nobody is manufacturing the Serodiagnostic test kits in Gujarat. We had immediately circulated the notification to all chemists and druggists, stockists, retailers and doctors. We conduct regular check ups to ensure that the ban is effectively enforced.” The Ministry of Health and Family Welfare had issued Gazette Notification GSR432(E) and GSR433(E) dated June 7, 2012 prohibiting the import, manufacture, sale, distribution and use of 'serodiagnostic test kits for diagnosis of TB with immediate effect in the country. The serodiagnostic test kits for diagnosis of TB give inconsistent and imprecise results leading to wrong diagnosis and their use is likely to involve risk to human beings whereas safer alternatives are available.

August 16-31, 2012

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TAPAN J RAY

KV SUBRAMANIAM

AJIT MAHADEVAN

AMAR KUREISHI

K VIJAYARAGHAVAN

Director General OPPI

President and CEO Reliance Life Sciences

Partner Ernst & Young

Chief Medical Officer & Head of Drug Development Quintiles Asia

Chairman, Sathguru Management Consultants & Regional coordinator, IPCALS, Cornell University

The long awaited draft ‘biosimilar guidelines’ of India, though a belated move by the Government, are certainly a step in the right direction

The Indian biosimilar guidelines factor (in) the Indian context of affordability and accessibility

A single-window procedure of obtaining marketing approval would have made the process similar to the developed world’s approval framework

The approach to developing and marketing biosimilars is very different and necessitates a new way of thinking

(It) ... suggests a global biosimilar strategy for both Indian manufacturers and the big multinational players that begins in India

ndia joined a select but growing club of nations when Dr MK Bhan, Secretary of the Department of Biotechnology (DBT), Government of India, released the draft guidelines for manufacturing and marketing of biosimilar drugs in India this July. Initially slated to come into effect from this Independence Day, August 15, the regulators postponed the implementation date to September 15, to give stakeholders more time to send their comments and suggestions on the draft guidelines to the DBT. Will India be able to position itself as a manufacturing hub for biosimilars, in the same way that it has done with

generic drugs? Clearly, small-molecule generics are losing their sheen. The wafer thin margins, thanks to low entry barriers, make it a high volume, low margin business. In contrast, the biosimilar opportunity promises to give better margins, even after patent expiry, as the cost and complexity of biosimilar development and manufacturing prevents the entry of too many players. Thus it is no wonder that the share of biologics in the global biopharma market is projected to rise to 28.9 per cent in 2015, from a base of 4.5 per cent in 1990. Similarly, the share of biosimilars among biologics is projected to rise from 0.1 per cent in 2009 to 6.4 per cent

in 2017. (See chart: Growth rate of biologics and biosimilars versus traditional drugs). Remicade (i&i’s infliximab) serves a good example of the biosimilar boom around the corner. Reportedly the top selling biologic and monoclonal branded antibody with $8.5 billion in sales in 2011, analysts predict that the brand could well turn out to be the top selling branded drug in 2012. It would be fair to say that many biosimilar manufacturers are waiting for Remicade to fall off the patent cliff in 2013. And Remicade is not alone on this path. In fact, various reports predict that biologic patent expiries worth more

The allure of biologics: Patent expiries from 2012 - 2019 ($billion)

Ingredient

Originator

Therapeutic indications

Global market size

Patent expiry (in the US)

Enbrel

Etanercept

Amgen

Rheumatoid arthritis treatment

6.6

2012

Epogen

Epoetin-alpha

Amgen

Anaemia treatment

5.0

2013

Remicade

Infliximab

i&i

Rheumatoid arthritis treatment

5.9

2013

Avonex

Interferon beta-1a

Biogen Idec

Multiple sclerosis

2.3

2013

Rebif

Interferon beta-1a

Serono

Multiple sclerosis

2.1

2013

Humalog

Insulin lispro

Eil Lily

Diabetes treatment

2.0

2013

Neupogen

Filgrastim

Amgen

Neutropenia

1.3

2013

Cerezyme

Imiglucerase

Genzyme

Gaucher disease

0.8

2013

Rituxan

Rituximab

Genentech

Non-Hodgkin's lymphoma, etc.

5.7

2015

Neulasta

Pegfilgrastim

Amgen

Stimulates white blood cell production

3.4

2015

Lantus

Insulin glargin

Sanofi-Aventis

Diabetes treatment

4.2

2015

Erbitux

Cetuximab

BMS/Merk

Colorectal cancer, etc.

1.6

2015

Humira

Adalimumab

Abbott & Eisai

Rheumatoid arthritis treatment

5.5

2016

Herceptin

Trastuzumab

Genentech

Breast cancer

4.9

2019

Avastin

Bevacizumab

Genentech

Colorectal cancer, etc.

5.8

2019

Lucentis

Ranibizumab

Novartis

Wet AMD

2.3

2019

Source: Quintiles, Hyundai Securities

EXPRESS PHARMA

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August 16-31, 2012

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WILLIAM LEE Head of Regulatory Strategy Quintiles Asia

than $40 billion are expected by 2016. (See table: The allure of biologics: Patent expiries from 2012 - 2019)

Going by the (rule) book

The Indian guidelines make no mention of data exclusivity but that does not mean that there is no protection of intellectual property

August 16-31, 2012

With such a huge market opportunity opening up, it is no wonder that regulation for biosimilars across the world is keeping pace. (See box: History of biosimilar guidelines) Upto now, the regulatory process for biosimilars in India was on a case by case basis, using an abbreviated version of the pathway followed for small molecule drugs, involving the Drug Controller General (India)'s office under the Central Drugs Standard Control Organization (CDSCO) and DBT. While the CDSCO evaluated the safety, efficacy and quality aspect, the DBT through the Review Committee on Genetic Manipulation (RCGM) was responsible for overseeing the development and preclinical evaluation of recombinant biologics. This system, seen as an ad hoc approach, was fraught with flaws. Tapan Ray, Director General, Organisation of Pharmaceutical Producers of India (OPPI) says that there have been instances of so called ‘biosimilar drugs’ being approved for marketing, reportedly with sub-optimal testing and dossiers, thereby putting into question product quality, comparability and patient safety. Thus he is firmly of the opinion that the long awaited draft ‘biosimilar guidelines’ of India, demonstrating an overall similar-

ity in the philosophy and approach with the those in the US and Europe, though a belated move by the Government, are certainly a step in the right direction. The ad hoc process also meant inherent delays, points out Shoibal Mukherjee, Chief Medical Officer, Quintiles India & Head, Asia Medical Sciences Group. According to him, India’s new draft guidelines have made the pathway much clearer which he believes will lead to a reduction in approval timelines, but he adds an important caveat: “provided the Government infrastructure is in place to support the requisite approval processes.” The ad hoc process may have had its flaws, but it got the job done: more than 20 biologics have been approved in India by this process. But now with more biologics going off patent, the Indian regulators clearly felt the need for a more formalised approach, in line with global norms. Priyank Gupta and Aditi Gehlot, patent attorneys, Legasis Services point out that most of these biologics and the process to make them, were invented between 1990-2005 and were never patented in India. They opine that the draft guidelines thus open prospects to bring more biosimilar brands in the market at perhaps the lowest costs on this planet.

Similar but not same Going by initial reactions to India's

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biosimilar guidelines, they seem to be along expected lines, given that industry representatives were part of the Task Force which drafted the guidelines. KV Subramaniam, President and CEO, Reliance Life Sciences, one of the representatives from industry on this task force, believes that the Indian biosimilar guidelines factor (in) the “Indian context of affordability and accessibility”. While ensuring product safety, quality and efficacy, he points out that “extremely onerous clinical trials are obviated, thereby enabling biosimilars to be launched in a faster time frame at competitive costs in relation to other country context.” Dr Ajay Kumar Sharma, Practice Head - Pharma, Healthcare Practice, Frost & Sullivan, South Asia & Middle East too opines that while they seem to be based on current global guidances like that of the European Union, they are tailored to the needs of the local Indian market and the players in the Indian market. Attempting to read the Indian regulator's philosophy, William Lee, Head of Regulatory Strategy, Quintiles Asia opines that it is very clear that the Government is creating a level playing field for Indian biosimilar players to compete globally. These draft guidelines “define an approach and provide a framework” for the development of biosimilars. Once implemented, he believes they will evolve further with feedback from the industry. The guidelines already seem to be evolving,

EXPRESS PHARMA

M|A|R|K|E|T PRIYANK GUPTA Patent Attorney Legasis Services

Post-implementation of the guidelines, India will be placed at least somewhere in the global biosimilar regulated market

SHOIBAL MUKHERJEE

DR AJAY KUMAR SHARMA

Chief Medical Officer Quintiles India & Head, Asia Medical Sciences Group

Practice Head-Pharma, Healthcare Practice South Asia & Middle East Frost & Sullivan

The new guidelines have made the pathway much clearer ... provided Government infrastructure is in place to support the requisite approval processes

The major challenge would be implementation of the policy.

given the delayed implementation deadline. Lee says the guidelines are similar to those developed by the US FDA, EMEA and WHO. The areas of similarity with global guidelines are that they focus on quality characterisation, on the sequential development of the compound starting from quality characterisation and the silence on the interchangeability of compounds. The Indian guidelines also provide guidance on the type of post-marketing data required for similar biologics.

Tailor-made for India Ankit Suri, Associate Vice-President of Tecnova India terms the draft guidelines as an excellent attempt to streamline the regulation of the bio similars, but while we keep pace with other regulatory bodies like the US FDA and EMEA, “we should not blindly ape what they are following, we should have our own identity.” The Indian biosimilar draft guidelines do reflect their own identity, going by the key differences from global biosimilar guidelines. Firstly, in addition to the DCGI/CDSCO and RCGM/DBT, the draft

biosimilar guidelines have added a third: the Genetic Engineering Appraisal Committee (GEAC) which functions under the Ministry of Environment and Forests (MoEF) as a statutory body for review and approval of activities involving large scale use of genetically engineered organisms (GMOs, also referred as living modified organisms, LMOs). The involvement of three authorities, under three ministries is the most obvious differentiating factor. Ajit Mahadevan, Partner, and Suvajit Mahapatro, Manager, Ernst & Young (EY) point out that a single-window procedure of obtaining marketing approval would have made the process similar to the developed world’s approval framework. In fact, in addition to being dependent on multiple regulatory agencies, the draft biosimilar guidelines lean on other guidelines (like the Recombinant DNA Safety Guidelines, 1990; CDSCO guidance for industry, 2008; Guidelines and handbook for institutional biosafety committees, 2011 etc.) and other Acts. The Legasis team cautions that this situation may cause procedural delays for approval.

ANKIT SURI Associate Vice-President Tecnova India

An excellent attempt to streamline the regulation of biosimilars, but we should not blindly ape what they are following, we should have our own identity

Another key difference is that India's draft regulations have not defined the timelines in the approval process, unlike the biosimilar guidelines in the EMEA, while have well defined timelines for each part of the approval process. Sharma of Frost also points out that there will be instances where use of logical interpretations would be helpful to rationalise the policy from case to case basis.

Charting the challenges Mahadevan and Mahapatro of EY presume that although few pharma manufacturers currently market biosimilars in India, there will be challenges for them to compete with the multinationals once they get marketing approval in India. But India's draft biosimilar guidelines pose challenges for both groups on these fronts. Firstly, as the EY team points out, proving similar bio-equivalence, as compared to the reference molecule, is a complex process. Suri of Technova too zeroes in on this point, pointing out that in case the reference biologic is used for more than

The biosimilar opportunity

ccording to an EY analysis, the global market for biosimilars was around $378 million till 1H 2011. According to Fitch and IMS’ health forecast, this is likely to rise to around $2.5 billion by 2015. The growth drivers for the biosimilars market are the patent expiries of key biologic drugs like Amgen's Enbrel (patent expires this year, the brand had a global value of $6.6 billion in 2009), i&i's Remicade (2013, $5.9 billion), Genentech's Rituxan (2015, $5.7 billion), BMS/Merck's Erbitux (2015, $1.6 billion), Abbott & Eisai's Humira (2015, $5.5 billion), and two of Genentech's brands: Herceptin (2015, $4.9 billion) and Avastin (2015, $5.8 billion). Estimates are that biologics worth more than $40 billion will face patent expiration by 2016. Mahadevan and Mahapatra of EY also predict that though biologics are limited to certain therapeutic categories and regions, growing demand and changes in regulatory framework will drive the momentum in future. Tapping the biosimilars opportunity will require staying power as these are drugs of high molecular complexity and are unstable. Their mode of delivery needs to be intravenous and all these factors result in a high capex requirement of around $10–$15 million, which may scale up to $400 million for a mammalian cell line. All these factors mean that in the medium term, there will be challenges in gaining access to regulated markets, but emerging ones will have better potential for the Indian players, according to EY. Even given these pain points, they point out that given the limited healthcare spend and underlying affordability issues, there could be an attractive opportunity for the established players to leverage volumes by benefiting from the price point of their drugs. Long term, EY believes that due to expiry of key patents and economic instability in the developed economies, will result in tight austerity measures to curb the expenditure made on healthcare. This would create an opportunity for biosimilars to gain a market share. As with small molecule drugs, the US will be the key global market for biosimilars (worth around $25 billion, as per IMS) in 2020, and represent a 10 per cent share of the total biologics market.The overall penetration of biosimilars within the off-patent biological market is forecast to reach around 50 per cent by 2020, assuming there is a price discount in the range of 20 per cent – 30 per cent.

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one indication, the efficacy and safety of the similar biologic has to be justified and if necessary demonstrated separately for each of the claimed indications. Justification will depend on clinical experience, available literature data and whether or not the same mechanism of action is involved in specific indications. Secondly, timelines for the approval process will be the key parameter and Government funding will play an important role to establish infrastructure to support clinical testing laboratories. A third barrier is that manufacturing or replicating similar cell lines will require expertise, which will eliminate inexperienced players from the competition. Cost is the fourth hurdle and will definitely play a key role in the case of substantial investments made on biosimilars. And finally, comparability testing of biosimilar medicines with reference products (requiring non-clinical and clinical trials including PK (Pharmaco kinetic) /PD (Pharmaco dynamic) testing and trials for safety/immunogenicity and efficacy) will be needed, therefore, efficient and effective testing labs will be key infrastructure requirements. Subramaniam of Reliance Life Sciences also alludes to these factors, when he says companies with stakes in biosimilar business have to gear up to follow these guidelines. He shortlists three areas where these companies will need to invest in: people, analytics and clinical trials.

August 16-31, 2012

Further, he warns that as preclinical animal toxicological studies and clinical trials involve comparison to the innovator product, these activities may escalate the costs and extend the timelines for approval of a biosimilar in relation to what they are now. In fact, it’s not just industry applicants who will have to gear up; the regulators too will need staffing, human resource and infrastructure to expedite the approval process, points out Sharma of Frost & Sullivan. Shortages on this front could hamper the implementation of the policy. K Vijayaraghavan, Chairman, Sathguru Management Consultants & Regional coordinator, IPCALS, Cornell University pinpoints another provision of the guidelines that will delay market entry for biosimilars in some cases: The Indian (draft) guidelines provide that where “the reference biologic is not authorised in India, it should have been licensed and marketed for at least four years with significant safety and efficacy data.” His analysis is that since for the foreseeable future, new biologics will be predominantly pioneered in the US and Europe, there will be a number of recently-developed products that fall into this category, and will await either the approval of the reference drug in India, or the passage of four years after approval elsewhere.

An India-first strategy? Vijayaraghavan points out another major difference between the Indian

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regulatory regime and that of the US and Europe: the lack of regulatory market exclusivity for first-approved products. In the US and Europe, biosimilars cannot be approved until 10 or more years after approval of the reference product. Without this limitation, sales of biosimilars in India are only restricted by patent exclusivity. And even patent exclusivity is not so much of a barrier, given their less well-developed patent regime for biologics. According to him, the combination of an established biosimilar regulatory pathway which is similar to the major markets plus the lack of market exclusivity suggests a global biosimilar strategy for both Indian manufacturers and the big multinational players that begins in India. In other words, as he spells out, in order to hasten approval worldwide, companies will first seek approval in India, which may be possible long before other jurisdictions, then use the same data package, plus long-term pharmacovigilance data gathered from sales in India and required post-marketing studies as the basis for approval elsewhere at the first moment possible. In this way, as per Vijayaraghavan's analysis, the regulatory package for other markets will be “paid-for” by sales in India, plus the likelihood of worldwide approval will be enhanced by a long history of safety in India.’ According to Vijayaraghavan,“The opportunity for small and medium enterprises to take part in this with the

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support of DBT funded initiatives such as the Biotechnology Industry Partnership Programme is enormous”. He anticipates that it could also serve to “converge competencies in evaluation and pre-market assessment, thereby opening avenues for inclusive engagement of corporate sector in market access.”

Growth rate of biologics and biosimilars versus traditional drugs

A case for data exclusivity? The Legasis attorneys feel that though the draft guidelines are an initiative to streamline the approval process, they only emphasise regulatory requirements and lack provisions like biosimilar interchangeability and exclusivity for first (mover) interchangeable product as under the US laws which could further boost the biosimilar industry in India. Ananda Chakrabarty, Co Founder, Amrita Therapeutics and Professor–Microbiology, University of Illinois, sincerely hopes that the Indian Government, when formulating the final guidelines, will take into consideration the position that his company espouses, namely, that the Government of India should promote and develop new types of drugs, and should encourage innovations rather than just copying or formulate guidelines that just encourage copying. Chakrabarty reasons that while India's thriving generics industry is “adored and admired” by many nations for bringing cheap medicines for the general population, the generics industry does not make a whole lot of money and therefore contributes little to bolster the country's economy. “Given the fact that the Indian Government spends a sizeable amount of money in promoting academic research, I don't think it gets any real economic return from such academic investments. That needs to change. The pharma industry needs to pay some attention to bringing innovative products to the global market and the Government should encourage such activities for the academic sector as well,” he affirms. Taking forward his argument, Susan Finston, CEO and MD, Amrita Therapeutics, points out that especially for smaller companies like Amrita, who do not have a phalanx of patent attorneys to litigate against patent infringers, data exclusivity/patent linkage or at least a minimal time period for Return on Investment (ROI) prior to eligibility to submit the FOB application and/or gain final regulatory approval, is required to make back the considerable investment that seed funders and the cofounders, promoters, friends and family have put in. Finston alludes to the irony that in Amrita's case, such features, currently absent in India, will help the DBT itself, as well as Amrita’s other funding agen-

Sources: IMS, Reuters, Business Insights, Evaluate Pharma, Vision Gain, DataMonitor Feb 2011, Quintiles cies like the Gujarat Venture Finance Limited (GVFL), get faster and better RoI on their investment in Amrita's product development efforts. Early research on some of Amrita’s priority candidates was initiated in January 2010 at Ahmedabad’s BV Patel Pharmaceutical Education and Research Development (PERD) Centre. India’s draft biosimilar guidelines spark a series of queries from Finston for the regulators, all reflecting the long way ahead. For starters, she asks if the Government of India will provide sufficient well-trained personnel to review and evaluate biosimilar data packages? Secondly, how much data will be required on a case by case basis, e.g., how long a time period will be required for toxicity and related safety/effectiveness tests in animals and in humans? Her third query is how will human clinical studies for biosimilars be compared to phase I, II or III studies for the comparator biologic? How many patients will be enrolled and over what time periods?

Possible legal loopholes The Legasis team points out that as India’s draft biosimilar guidelines do not link regulatory approval with patents issued by the Indian Patent office (IPO) in order to address any possible complications arising from the infringement issues related to manufacturing, import or marketing of the biosimilar, it is likely to bring hurdles relating dishonouring patents. Whereas, the US guidelines on biosimilars clearly discusses any patent infringement issues which may arise and pre-approval negotiation proceedings between reference product owners and interchangeable biosimilar biologic applicant to minimise patent litigation. The lack of provision for data exclusivity to the reference biologic product owners means that the biosimilar manu-

facturer will be able to ride on data supplied by the prior approved reference biologic. The Legasis patent attorneys predict that such a situation may also prompt the innovator company to adopt a different IP strategy and cite the 'trade secret' option to avoid submitting the data of new biologics. Lee of Quintiles too opines that multinational biopharma companies may be more hesitant to develop innovator products in India as they may well perceive that that there is no protection of intellectual property, although this is not the case with the IPR in place. Though the Indian guidelines make no mention of data exclusivity, Lee points out that that does not mean that there is no protection of intellectual property. The IPR is in place so one can always refer to the data as the patent is still in force, he opines.

Product specific guidelines Another suggestion from the Legasis patent attorneys is to have product specific guidelines, as done in the EU. With EU being the pioneer in implementing laws for biosimilar, it felt that product specific guidelines for complex biosimilars would present clear guidelines in terms of data requirements and evaluation. They point out that a similar approach for the Indian biosimilar guidelines would avoid any case to case discretion by regulatory agencies. The Legasis team also points to some possible loopholes like the provision that as per the Indian draft biosimilar guidelines, confirmatory clinical safety and efficacy study can be waived if certain conditions are met by the similar biologic. So also in another provision, clinical trials should have sufficient number of patients for acceptable period of time to measure any significant difference on safety between similar biologic and reference

History of biosimilar guidelines

urope has a pathway in place, with 16 biosimilars approved by the European Medicines Agency (EMA) while the US guidance is in development. Canada has a draft guidance issued while Australia is using the EU approach. Japan has issued final guidance. WHO issued final recommendations in 2010. Of the BRIC block, India's draft guidance on biosimilars was released in July 2012. Brazil had already issued its final guidance. While Russia still has no specific pathway for biosimilars, a guidance is being developed in China. In the rest of the world (ROW), some countries are beginning to implement guidance following EMA or WHO (e.g. Malaysia, Taiwan, Korea); many others do not have the healthcare infrastructure to support complex biologics.

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August 16-31, 2012

M|A|R|K|E|T

biologic. Such provisions are open ended to allow and be a matter of discrepancy in certain cases.

A good first step ... Notwithstanding the many queries and challenges of adhering to the biosimilar guidelines, there is broad recognition that not having them will cast a shadow of doubt on biosimilars approved in India. For instance, Dr Reddy’s Laboratories’ Reditux is not considered the world’s first biosimilar antibody even though it got the nod in 2007. That honour goes to Celltrion’s Remsima because South Korea’s biosimilar guidelines are in line with global guidelines. Ray of OPPI points out that “a science-driven ‘biosimilar guidelines’ will provide a regulatory framework or pathway to ensure that ‘biosimilar drugs’ approved in India are of good quality and demonstrably similar in efficacy, safety and immunogenicity to the original reference products.” He believes that India has the potential to become one of the key players in the development and manufacture of biosimilar drugs, not only to serve the needs of the local population, but also for export to large developed markets needs. “The need for such a regulatory framework and comprehensive guidelines is even greater in the light of currently suboptimal pharmacovigilance system in India,” reasons Ray. “Better late than never”, is the stance of the Legasis team as well, maintaining that post-implementation of the guidelines, India will be placed at least somewhere in the global biosimilar regulated market.

vary according to regions, points out Kureishi. For instance, in the US, biologics are paid for by third parties and are very expensive. Physicians have litigation challenges, patients do not necessarily want cheaper drugs and there are pressures on third party payers and influences from originators to slow down the market. In Europe, most countries have national health services and are running significant debt. They are looking at ways to

reduce their healthcare budgets through lower cost solutions, while balancing safety. Coming to countries like India, South East Asia and Latin America, Kureishi points out that the major problem is access and affordability. Often the choice is between a biosimilar or nothing and so one has to consider practical solutions of affordability and availability of drugs, reasons Kureishi. Regulators will put into

place laws to cope with such issues and challenges and evolving regulations will in turn trigger off different market strategies. Kureishi points out how some Indian companies have approved drugs in India and then launched in select small Asian markets. Chinese biosimilar companies are doing the same. This would be a ‘local plus’ strategy, as opposed to a true local, global or emerging market strategy. 'Cheaper' in bio-

logics cannot be equalled to 'not as good', he advises. All in all, given that the Indian biosimilars market is not yet as mature as in regulated nations, it will take some time for the regulatory process to evolve and stabilise. Biosimilar companies in India have no choice but to gear up to these benchmarks as they evolve. The saying 'No pain, No gain', though a trifle trite, fits the bill to the T . viveka.r@expressindia.com

... towards a global play Given India’s status as a generics major, can it apply the same formula to biosimilars? Not so apparently. “The success of Indian companies in generics could be an inherent stumbling block as it prevents these companies from thinking in the broader context of biosimilars,” cautions Amar Kureishi, Chief Medical Officer and Head of Drug Development, Quintiles Asia. He believes that the approach to developing and marketing biosimilars is very different and necessitates a new way of thinking. The issues and challenges of developing biosimilars August 16-31, 2012

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M|A|R|K|E|T DEAL TRACKER

M&A activity in the pharma sector decreases in both volume and value terms The pharma sector recorded 27 M&A transactions in July 2012, against the previous six months’ average of 49 transactions Figure: M&A (including private equity) trend analysis

Mergers and acquisitions &A activity in the pharma segment continued its declining trend, in both value and volume terms, while cross-border activity in the sector remained steady. The sector recorded 16 cross-border transactions in July 2012, against the previous six months’ average of 17 deals. In one of the key deals announced during the month, UK-based AstraZeneca acquired neuroscience assets from Link Medicine Corporation, a US-based biopharmaceutical company. This transaction provides AstraZeneca with an opportunity to enter into the vital research space in Autophagy. Autophagy is an intracellular process that clears and recycles misfolded proteins, which is an emerging area of research that can be applied to a range of neurodegenerative diseases, including Parkinson’s and Alzheimer's disease. The M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of previous six months (Jan 2012–Jun 2012). According to Datamonitor's MedTRACK database, the pharma sector recorded 27 M&A transactions in July 2012, against the previous six months’ average of 49 transactions. In value terms, the sector recorded deals worth $2.5 billion against the previous six months’ average of $10.4 billion. The Indian pharma sector witnessed no deals during July 2012, against the average of 1.8 deals over the previous six months.

Source:

Top M&A deals (Jul 2012) Rank

Date

Target

Acquirer

Deal value ($m)

Jul 16, 2012

Par Pharmaceutical Companies, Inc. (US)

TPG Capital, L.P. (US)

Jul 3, 2012

AgraQuest, Inc. (US)

Bayer CropScience AG (DE)

1,900.00

Jul 2, 2012

BioCeuticals Pty, Ltd. (AU)

Blackmores (AU)

40.98

Jul 18, 2012

Alimera Sciences, Inc. (US)

Palo Alto Investors; Sofinnova Ventures, Inc.; New Enterprise Associates, Inc.

40.00

Jul 17, 2012

AMT Labs, Inc. (US)

Innophos, Inc. (US)

19.50

Jul 11, 2012

Aprogen, Inc. (KR)

BINEX Co., Ltd (KR)

14.02

Jul 13, 2012

Bavarian Nordic A/S (DK)

OrbiMed Advisors, LLC (US)

11.79

Jul 19, 2012

Caprion Proteomics Inc. (CA)

Chicago Growth Partners (US)

425.00

4.50

Source:

Venture funding Companies in the pharma sector raised $359.7 million during July 2012, against the previous six months’ average of $242.3 million. In terms of volume, the sector recorded 19 venture funded deals, compared to the previous six months’ average of 25.3 transactions.

Figure: Venture financing trend analysis

Notes and definitions

60.00

MedTRACK is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. MedTRACK’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

Agile Therapeutics, Inc. (US) Aisling Capital; Care Capital LLC; Investor Growth Capital; ProQuest Investments; Kaiser Permanente Ventures; Novitas Capital

40.00

For more information, visit us at www.medtrack.com

Source:

Top venture financing deals (July 2012) Rank

Date

Target

Jul 25, 2012

bluebird bio, Inc. (US)

Jul 19, 2012

Investors

Deal value ($m)

Deerfield Partners; RA Capital Management, LLC; Ramius, LLC; ARCH Venture Partners; Third Rock Ventures, LLC; TVM Capital Group; Forbion Capital Partners; Shire plc; Undisclosed Investors

Definitions

Jul 23, 2012

Chiasma, Inc. (US)

MPM Capital; Abingworth Management Limited; ARCH Venture Partners; 7 Med Health Ventures; F3 Ventures Limited; Fredric Price

38.50

Jul 5, 2012

PsiOxus Therapeutics Limited (GB)

Lundbeckfond Ventures; Invesco Perpetual; SR One; Imperial Innovations Group PLC

34.42

Jul 23, 2012

PTC Therapeutics, Inc. (US)

Credit Suisse First Boston Equity Partners, L.P.; HBM BioVentures, Ltd.; Vulcan Ventures; Celgene Corporation; Delphi Ventures; The Column Group; Novo A/S; Undisclosed Investors

30.00

1.Deal value trend is based on transactions where associate values have been disclosed. 2.Trend analysis excludes rumored and terminated deals. 3.Value and volume analysis excludes private equity exits.

Source:

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August 16-31, 2012

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Pharmexcil and MHLW, Japan to promote generic drugs Invites Indian pharma players to supply drugs at affordable price Usha Sharma Mumbai harmaceuticals Export Promotion Council (Pharmexcil) and senior officials from Ministry of Health, Labour and Welfare (MHLW), Japan recently met to discuss regulatory compliances in Japan for pharmaceuticals. The Pharmexcil initiative kicked off with a meeting in Delhi on July 26 followed by a meeting in Mumbai on July 27. While inviting India pharma companies to supply generic drugs at affordable prices in the Japanese market, Ministry of Japan officials outlined the steps being taken by their Ministry to promote generic drugs. Speaking at the Mumbai meet, Hiroyuki Kawabata, Deputy Director Economics Affairs Division, Health Policy Bureau said, “In Japan, 30 per cent of the treatment cost is borne by the patients while the remaining by the insurance companies. The Japanese Government also provides certain amount to individual insurance companies. To make drugs more affordable and more easily accessible, Ministry of Japan is trying its best to promote generic drugs. Currently, generic drugs have a 22.8 per cent share of the market and we aim to expand this to reach 30 per cent by this year end.” Presently, the Japanese pharma market contributes 19.1 per cent new drugs, 34.3 per cent new drugs with generics, 22.8 per cent generic drugs and 23.9 per cent other drugs. Kawabata further said, “With an initiative to promote generic drugs in Japan, the Government has launched the public incentive programme in April 2012. Various groups, associations, insurance companies have come together and are in continuous discussions to promote generic medicines. And it seems that the entire country is now engaged in promoting generics medicines.” In addition to this, MHLW is continuing to reform and increasingly accepting non- Japanese Asian data as part of the regulatory approval process. The state gives a pharmacist JPY40 (US $ 0.45) per prescription if generic drugs account for at least 30 per cent of dispensed medicines over a three-month period. Doctors have to specifically indicate on the prescription

August 16-31, 2012

Director General, Pharmexcil said, “This is only the beginning and I hope that Indian pharma players will utilise this opportunity, which exist in the Japanese market.” He also mentioned that all the regulatory issues faced by Indian pharma companies which

if a drug can not be substituted by a bio-equivalent copy. JJ Shah, Oceanic Pharmachem, Chairman said, “Indian pharma companies need to understand the regulatory framework, as the country has stringent regulatory policies.” Dr P V Appaji,

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remained unanswered till now, will be taken forward with the Japanese ministry. “We invite Indian manufacturers to supply good generic medicines to the Japanese market,” Kawabata summarised. u.sharma@expressindia.com

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CDSCO calls for suggestions on draft guidelines for compensating clinical trial victims Recommendations to be submitted before September 2, 2012 Usha Sharma Mumbai he Central Drugs Standard Control Organisation (CDSCO) has called for recommendations and suggestions on its draft guidelines, issued on August 3, 2012, for determining quantum of financial compensation to be paid in case of clinical trial related injury or death. It has welcomed the views of one and all, including the common public. However, the recommendations need to be sent within 30 days from the time the guidelines were issued i.e. on or before September 2, 2012. All the suggestions and recommendations will be reviewed by an expert committee set up by CDSCO before the Ministry of Health settles on the final provisions of the guidelines. The proposed draft rule 122 DAB in clause (1) and (2) provides that in case of trial related injury or death, financial compensation will be provided in accordance with the recommendations of the Ethics Committee as per the guidelines prescribed for the purpose. By the time the amended rules come into force, the guidelines should be in place for the purpose of implementation of the rules. This guidance document describes the methods to be followed by the Ethics Committees for calculating the quantum of financial compensation to be paid in case of clinical trial related injury or death.

According to a ministry source, “In November 2011, the Indian Council of Medical Research (ICMR) and CDSCO under Directorate General of Health Services and Ministry of Health and Family Welfare, drafted the noticification for compensation of research-related injury, which evoked strong response from the clinical research community. The quantum compensation draft guidelines (Aug 3, 2012) are linked to the (Nov 2011) detailed notification for compensation trial-related injury or death. By the time the amended rules come into force, the guidelines should be in place for the purpose of implementation of the rules and soon it will become a Rule.” As per draft guidelines, presently, there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial-related injury or death of the subject. However, Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from ethics committee. In case of death, their dependents are entitled to material compensation. Guidelines further provide that it is the obligation of the sponsor to pay the compensation. The guidelines recommend that there

needs to be a simple and expeditious procedure for payment of compensation and criteria for determining the amount of financial / material compensation to be paid in the cases of study related injury to the subject or in case of death to his/her nominee(s). To incorporate specific provisions for procedures to be followed for payment of compensation in case of trial related injury or death, draft rules have already been published which is under consideration for finalisation. The proposed draft rule 122 DAB in clause (1) and (2) provides that in case of trial-related injury or death, financial compensation will be provided in accordance with the recommendations of the Ethics Committee as per the guidelines prescribed for the purpose. This guidance document describes the methods to be followed by the Ethics Committees for calculating the quantum of financial compensation to be paid in case of clinical trial-related injury or death. These guidelines were formulated in response to concerns raised during Question Hour in Parliament and other forums regarding payment of compensation in the cases of injury or death in clinical trial. The Drug Technical Advisory Board (DTAB), the highest technical body under D&C, Act, has endorsed adoption of this GCP guideline for streamlining compensation related issues arising during clinical studies in India. u.sharma@expressindia.com

Commerce Ministry to discuss issues on non-tariff barriers in pharma industry with US and EU Pharma industry to form committee of all industry representatives Usha Sharma Mumbai n a move to promote Indian pharmaceutical industry, Anand Sharma, Union Minister of Commerce and Industry, Government of India, at a recently held meeting on Consultative Group on Exports of Pharmaceutical Products, discussed issues related to the non-tariff barriers imposed by the US and EU against Indian companies. The Government is going to discuss on non-tariff barriers with counterpart countries and ensure that the norms in TRIPS agreement are rightly followed and not bypassed. The meeting was attended by the pharma industry associations, experts and top CEOs of pharma companies, viz, Ranbaxy, Wockhardt, Panacea Biotech, Vimta Labs, Suven Life Sciences, GVK Bio Resources, etc. Commerce Secretary; Secretary, Department of Industrial Policy & Promotion (DIPP); Secretary, D/o Pharmaceutical; Additional Secretary, DOC; DCGI, JS, MEA, D/o Health and other senior officers were also present during the meeting.

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Sharma recalled that it was the entry of Indian generic medicines in the global supply chain which started an ethical debate worldwide between generics versus patented drugs, and ultimately the right of every citizen to access affordable quality medicines were upheld. While time and again there have been attempts by multinational companies to malign Indian generics as substandard, counterfeit, the resilience of Indian industry has withstood all these challenges. The Government is fully committed to support this vibrant sector. The Minister also apprised that substantial opportunities exist for Indian pharma industry in emerging economies like Russia, Africa, South America. He assured the industry stalwarts that the Government will take up the issue of non-tariff barriers being mounted by the US and EU against Indian pharma industry in bilateral forums at appropriate levels. Venkat Jasti, Chairman and CEO, Suven Life Sciences said, “The Government is trying to promote Indian pharma industry globally and continuous negotiation is going on. The Government

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wants to ensure that there will be no by pass in the TRIPS agreement as in the recent past, the industry faced many problems which were linked to this.” Jasti continued that the Government has planned to conduct review progress meeting in another two months and before that pharma industry will form a sub committee, which will have members from pharma companies, pharma industry associations, industry experts etc. The industry will share its issues with this sub committee, which will then take up these issues with the Government. The contribution of the Indian pharma industry in supplying affordable, quality generic medicines was lauded by the attendees in the meeting. SR Rao, Commerce Secretary, informed the gathering about the implementation of the Brand India Pharma campaign, which was launched in Japan in March 2012 to position India as the Pharmacy of the World and Brand Indian pharma products as affordable, quality medicines. Industry stalwarts made a strong plea Continued on Pg 24 August 16-31, 2012

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Q1 results registers ups and downs in Indian pharma sector Indian pharma companies have recently released Q1 results, Express Pharma highlights the Q1 performance Indoco Remedies s per the un-audited results for First Quarter (Q1) of the financial year 2012-13, Indoco Remedies recorded a growth of 20.2 per cent in the revenues at ` 1511.6 million during Q1 of FY 2012-13 as compared to ` 1257.4 million over the same quarter last year. The earnings before interest, taxes, depreciation, and amortisation (EBIDTA) for the quarter was 19.3 per cent at ` 292.2 million as compared to 16.3 per cent at ` 205.0 million over the same quarter last year.

Jubilant Lifesciences n Q1 FY2013, income from operations was at all time high of ` 1,240 crore with 31 per cent year-onyear (YoY) growth. The growth was backed by overall volume increase of 23 per cent. Foreign exchange movement was also favourable in terms of revenue and profit growth. EBITDA at all time high of ` 277 crore grew 46 per cent YoY and the EBITDA margins were at 22.3 per cent, up from 20 per cent reported last year. Profit before exceptional items, tax and minority interest was at ` 158 crore, up 64 per cent YoY. Reported Profit after Tax (PAT) of ` 5 crore was after accounting for unrealised mark to market forex loss on loans of ` 104 crore. Normalised PAT stood at ` 109 crore for Q1’FY13, up 34 per cent compared to same quarter in FY12.

Lupin upin's net sales grew by 44 per cent to ` 22,192 million during Q1 FY 2012-13, up from ` 15,432 million (Q1 FY 2011-12). EBITDA grew by 63 per cent to ` 4,811 million during Q1 FY 2012-13, up from ` 2,955 million (Q1 FY 2011-12). Profit before tax (PBT) grew by 67 per cent to ` 4,057 million during Q1 FY 2012-13, up from ` 2,426 million (Q1 FY 2011-12). Net profits grew by 33 per cent to ` 2,804 million during Q1 FY 2012-13, up from ` 2,101 million (Q1 FY 2011-12).

due to 27.7 per cent and 50.1 per cent growth in Indian and US formulations business respectively. EBITDA margin at 22.1 per cent improved by 125bps sequentially and is now consistently improving QoQ. PAT declined by 3.1 per cent YoY due to higher tax rate as its Sikkim partnership firm has now come under MAT post budget.

Glenmark Pharma ccording to a report compiled by Fortune Group, Glenmark Pharma’s Q1FY13 numbers exceeded its expectations. The total income grew by 19.8 per cent YoY due to excellent growth across most business segments. Growing by 364bps sequentially, EBITDA margin at 21.1 per cent was above the estimate due to presence of Malarone and Cutivate in the US and strong domestic growth. Adjusted PAT grew slower than EBITDA at 15.5 per cent YoY due to higher tax rate and depreciation. Excluding lincensing income, Glenmark’s speciality business posted 22.9 per cent YoY growth as the company made excellent gains in India and ROW markets. India business continued to do well and posted 24.1 per cent growth YoY. The company’s generics business grew by a staggering 57.7 per cent on account of robust growth across regions.

Wockhardt ockhardt has delivered 95 per cent increase in Profit After Tax at ` 378 crore in Q1 of financial year 2012-13. The EBITDA at ` 502 crore grew by 61 per cent and represented 10th consecutive quarter of sequential growth. Consolidated revenues grew by 35 per cent to ` 1,426 crore over the corresponding quarter of financial year 2011-12. This represented 5th consecutive quarter of sequential growth in consolidated revenues. Wockhardt’s US and EU operations have been the major contributor in its growth and the momentum continued in this quarter as they contributed to 71 per cent of consolidated revenues.

Clariant Chemicals lariant Chemicals net sales for the quarter ended June 30, 2012 is up at ` 282.1 crore from Rs 260.1 crore for the corresponding period of the previous year. The profit (before exceptional items) for the same period stood at ` 44.1 crore compared to ` 43.7 crore in the previous year period. After considering the exceptional items and tax expenses, the net profit for the period amounted to ` 30.8 crore as against ` 30.4 crore in the previous year period. For the six month period ending June 30, 2012, the net sales rose from ` 488.3 crore to ` 521.4 crore, in comparison with the corresponding period of previous year. The net profit for the period amounted to `62.5 crore as compared to ` 253.9 crore in the previous year period. The board of directors of the company has considered the payment of an interim dividend of ` 10 (100 per cent) per share for the year 2012.

Cadila Healthcare adila Helathcare has reported its Q1FY13 results. According to a report compiled by Fortune Group, the total income grew by 25.2 per cent YoY

Continued from Pg 22 for timely approvals and procedural simplification by Drug Controller General of India (DCGI) for clinical trials, import of samples, etc. They also requested liberal funding through venture capital vehicle for giving an impetus to R&D and innovation to this knowledge-based industry. Industry stalwarts were of the opinion that given the right impetus and pol-

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Cipla ortune Group in its report has mentioned that Cipla’s Q1FY13 numbers were higher than expectation. The total income grew by 23.3 per cent YoY due to higher than expected growth domestically and Lexapro supply under 180 days exclusivity to Teva. The management believes that the growth in FY13 would be higher than 10-15 per cent as was guided after the Q4FY12 results. It has indicated that the growth of domestic anti-asthma and antibiotics space was in excess of 20 per cent. Domestic growth is expected to decline to 16-17 per cent going forward. The SEZ in Indore is currently operating at 45-50 per cent capacity and has generated ` 1,900 million in sales.

Aurobindo Pharma ccording to a report by Fortune Group, Aurobindo Pharma's Q1FY13 numbers were below estimates. Led by its API and US formulations business, total income grew by 12.8 per cent YoY. The PAT declined by 53.3 per cent YoY due to higher interest costs and depreciation.

icy initiatives, and procedural simplification, the Indian pharma industry is capable of doubling the exports rather achieving a target of $50 billion in the next five years. Sharma assured the industry that a Committee of Secretaries of the concerned department will be set up to consider the suggestions to take Indian pharma industry on a growth trajectory in a time bound manner. u.sharma@expressindia.com August 16-31, 2012

M|A|R|K|E|T PRE EVENTS

P-MEC India to showcase pharma machinery products To be held in Mumbai from November 21—23, 2012 -MEC India, the most talked about pharmaceutical machinery and technology event is going to be held at Bombay Exhibition Centre. The event from November 21-23, 2012, will see leading Indian and international pharma machinery exhibitors showcase their latest technologies and launch their products. Halls 5 and 6 will showcase the latest pharma machinery and production processes involved in tablet and capsule filling, coating, packaging, bottle / vial filling. Also, on display will be analytical instruments, clean room equipment, process control automation, filtration/ separation processes and more. P-MEC focuses on key challenges in pharma services to develop more efficient production routes and systems of increasingly complex healthcare products. At PMEC India buyers can connect with sellers of pharma machinery and equipment on an international scale. India’s domestic market is expanding and developing rapidly and so are the opportunities within pharma manufacturing, procurement and technology. Attendees can actively form partnerships and begin their purchasing process. Senior pharma decision makers from all over the world will come together during the three-day show to conduct business, establish and create new business opportunities, share knowledge and further existing relationships within the industry. The Indian pharma market is rapidly expanding, presenting exceptional opportunities and PMEC India will give those involved in pharma manufacturing an unprecedented insight into the future of mechanical equipment and machinery. The exhibition will highlight the latest knowledge and the newest trends within the industry. The pharma machinery and equipment sector

for the last five years has made P-MEC India the place for exhibiting their latest products and technologies. P-MEC India is the preferred venue of leading companies to showcase their latest accomplishments in pharma machinery and equipment. The exhibit space will be occupied by exhibitors from China, Germany, Italy, India, Switzerland, Spain, Taiwan, the UK the US and other countries. The flagship event CPhI , along with ICSE and BioPh exhibitions are also co located with P-MEC. With the combined exhibit profiles of CPhI / ICSE / P-MEC / BioPh and over 800 exhibitors, the event will offer the pharma industry a unique value proposition of having under one roof four comprehensive events encompassing ingredients, machinery and technology, contract research and manufacturing and also bio pharma solutions. There has been remarkable advancement, particularly in the last two years, in the automation of pharma machinery. Sophistication, greater speed, high quality and appearance are important aspects in addition to the performance of these machines. India has state-of-the-art manufacturing facilities approved by international regulatory agencies. In the long-term, all indications point towards the continued growth of pharma outsourcing to India. This trend will perpetuate the rising demand for production equipments and related technologies, for which P-MEC India is the leading event platform. India’s competitiveness has given a further boost to exports and accelerated growth for Indian manufacturers in the recent past. The staging of such shows is expected to pave the way for the expansion of the country’s pharma manufacturing industry. EP News Bureau

Pharmexcil's India Pavilion at CphI Worldwide 2012 to project India’s pharma sector to new heights The 23rd edition of CPhI Worldwide 2012 to see participation from 140 countries harmaceuticals Export Promotion Council of India (Pharmexcil) will set up an India Pavilion at CPhI Worldwide 2012 to be held in Madrid, Spain. Pharmexcil will add lots of value to the India pavilion at this year’s edition of CPhI Worldwide. The key objectives of the event will be to improve the credibility of Indian pharma industry; to increase business on a sustainable basis and take it to the next orbit; to raise the awareness of Indian pharma success story; to create awareness that Indian generics are not counterfeits and they are bonafide medicines of standard quality; to protect it from dubious allegations by vested interests; to position India as global pharmacy of world and to highlight the growth drivers-government support and regulatory framework, cost efficiencies, technical capabilities. Major activities have been planned for India Show at CPhI-Worldwide this year. Anand Sharma, Minister of Commerce and Industry, Government of India with other top government officials are expected to take part in the event. Formal showcasing of Brand Pharma India logo, brand positioning state-

August 16-31, 2012

ment, business kit, film release and website at various platforms and options are being considered during CPhI-Worldwide. Apart from this, press conferences and media interviews highlighting India's pharma sector and its strength, showcasing of products from India by Council's members in India pavilion, global buyer seller meetings in India theme pavillion; business seminar including presentations by Global/Indian pharma CEO's on demand/supply positions, have been planned. CPhI Worldwide was first held in 1990 and 2012 will mark the 23rd edition of the event. Visitor numbers have subsequently grown more than one hundred fold to over 29,000 attendees from over 140 countries. Pharmexcil has taken about 960 square metre of space and made up stalls of various sizes (minimum 12 square metre, 13.5 square metre, 15 square metre, 16 square metre, 18 square metre and 20 square metre etc) would be available for its members. EP News Bureau www.expresspharmaonline.com

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IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation

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Date: September 6-7, 2012 Venue: The Lalit Mumbai, Sahar Airport Road Summary: The summit will provide a platform for the life sciences industry, regulators and information technology (IT) and IT enabled services industry to converge and consider IT intervention for enhancing competitiveness, reducing costs and bringing affordable medicines to market. Contact details: Manoj Trivedi Senior Manager Marketing & Program Development Drug Information Association A 303 Wellington Business Park I Marol, Andheri - Kurla Road Andheri (East) Mumbai - 59 Tel: +91 22.2859476 Cell: +91 98.19777493| Fax: +91 28.594762 Email: Manoj.Trivedi@diaindia.org

Pharmac India 2012 Date: September 8-10, 2012 Venue: Gujarat University Exhibition Hall, Ahmedabad Summary: Pharmac India 2012 is the third international exhibition of India’s prominent pharma machinery, equipment and material industry. The exhibitions' aims to bring pharma manufacturers, pharma packaging material and machinery along with APIs, biopharma with largest suppliers, distributors under one roof. Contact details: Varsha Surve Project Coordinator Orbitz Exhibitions 402, Navyug Industrial Estate, T.J. Road, Sewri (W), Mumbai 400 015 Tel: +91 22 2410 2801-03 Fax: +91 22 2410 2805 Cell: 09322037955 www.orbitzexhibitions.com www.pharmacindia.com

Disinfectant Qualification – Why and How; Microbial Films – A Growing Concern; Labelling Innovations and Solutions; Retrofitting of Labs in Green Way; Analytical Methods Update on Technology Transfer – SOP and Practice; Application of Separation Techniques in Pharma and Bio Pharma. Contact details: Prachi Rane, IDMA 102/B, A Wing, Poonam Chambers Worli, Mumbai-400018 Tel: +91 22-24974308 / 24944624; Fax: +91 22-24950723 Cell:+91 9867634383) Email: ppr@idmaindia.com

2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012) Date: September 28-29, 2012 Venue: Mohamed Sathak AJ College of Pharmacy, Sholinganallur, Chennai - 600119, Tamil Nadu, India Summary: Clinfocus Research Pvt Ltd, India in collaboration with Mohamed Sathak AJ College of Pharmacy, Chennai, Tamilnadu will host the 2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012). The focus of this symposium is The future vision and challenges in Nanotechnology'. On this platform, experts from different fields from different geographical locations will come together to discuss, to explain and share their future ideas suitable for profitable research. Participants can expect expert advice in the special discussion forum which is the speciality in this symposium. Students can start their projects based on the novel ideas discussed, teachers can update their knowledge and researchers can widen their knowledge by attending this symposium. Contact details: G Karthikeyan, M Pharm Convener-Nanopharma 2012 Cell: 91 9894286283

CPhl India 2012, P—MEC India 2012

For more information visit: www.agilent.com/chem/comply

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IDMA-APA-PAC 2012 Date: September 21-22, 2012 Venue: Hotel Hyatt Regency, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) will organise the 15th Pharmaceutical Analysts’ Convention (PAC) 2012. The main theme for this year's convention is 'Conformance to Emerging Global Quality Standards'. Eminent technical personnel from the Indian pharma industry, research and academia will converge and gettogether to interact on various recent developments. Dr Kamal Sharma, Managing Director, Lupin will be the Chief Guest and the keynote speaker. Dr Nitya Anand – Chairman , Ranbaxy Science Foundation will be felicitated with the Padmashree Award. Topics likely to be discussed at the convention are: Toxicology of Pharmacopoeial Impurities; New Developments in Chiral Chromatography; Quality Risk Management in Analytical Laboratory; Using QbD for Monitoring Product Quality; Pharmacoscintigraphy for Preclinical Evaluation of New Drugs and NDDS; Cultivating a GMP Culture; www.expresspharmaonline.com

Date: November 21-23, 2012 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India into its sixth year, with its co-located events with more than 800 exhibitors, is the largest and most comprehensive pharma industry event in South Asia. CPhI India is a great gateway to meet with key decision makers in pharma industry from around the world including India, China, Japan, the US, the UK, Germany, France, Italy, etc. P-MEC India is South Asia’s number one pharma machinery and technology exhibition and will give those involved in pharma manufacturing an unprecedented insight into the future of mechanical equipment and machinery. The exhibition will highlight the latest knowledge and the newest trends within the industry. Contact details: Milind Dixit Director - Exhibitions UBM India Tel: + 91 22 66122600, Fax: + 91 22 66122626 Email: milind.dixit@ubm.com August 16-31, 2012

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© 2012 KPMG International Cooperative (“KPMG International”). KPMG International provides no client services and is a Swiss entity with which the independent member firms of the KPMG network are affiliated. The KPMG name, logo and “cutting through complexity” are registered trademarks or trademarks of KPMG.

M|A|R|K|E|T POST EVENTS

Improving access, innovation, reach key to achieving UHC Putting Universal Healthcare (UHC) at the top of the agenda, OPPI’s recent conclave on ‘Improving Access, Innovation and Reach of Healthcare in India’ aired many perspectives connecting these inter-related topics, reviews Viveka Roychowdhury takeholders from across the healthcare spectrum, spanning pharmaceutical companies and healthcare institutions, WHO as well as Government of India representatives met on a common platform at a recent Conclave on ‘Improving Access, Innovation and Reach of Healthcare in India’ organised by the Organisation of Pharmaceutical Producers of India. Speaking about the first aspect, Tapan Ray, Director-General, OPPI reminded the gathering that access to healthcare comprises not just medicines, but more importantly a robust healthcare infrastructure including, doctors, paramedics, diagnostics, health centres and hospitals. In India the demand for these services has outstripped supply but the key focus of the Government has still remained primarily on access to medicines. Ray commented that there are about 40 health insurance schemes active in the country today, but all of them focus on hospital care; none of them cover domiciliary medical expenses or loss of livelihood due to ill health. He stressed that there is an urgent need to have a holistic approach in developing adequate healthcare infrastructure, efficient delivery system for medical supplies and creation of a talent pool of healthcare professionals/paramedics to ensure adequate access to healthcare for all the citizens of the country. Ray spoke about a study undertaken by OPPI on ‘Enhancing Healthcare Access in India’, which aims at identifying the key barriers in accessing healthcare today, what needs to be done to eliminate these barriers and develop a roadmap for improving healthcare access in the country. Moving on to innovation, the second aspect, Ranjit Shahani, President, OPPI and Vice Chairman and MD, Novartis India, commented that access to healthcare has to be considered in context to mortality rates and disease burden. As global population is growing, the disease burden due to noncommunicable diseases (NCDs) is growing fast, especially in poor income segments. This is in addition to the burden of communicable diseases, which remains a concern even though it is shrinking. This leads to the vicious circle of poverty and health. While life expectancy has more than doubled over the last century, the quality of life has not increased. Shahani mentioned how the developing world suffers the most, with nearly 10 million children dying before they reach their fifth birthday and 500,000 women succumbing to preventable illnesses during pregnancy and due to complications during childbirth. The unfortunate irony is that low-cost interventions are available that could prevent at least two-thirds of these deaths. Comparing the top risk factors

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Speakers in the inaugural session: (L to R) Ranjit Shahani, Dr K Srinath Reddy, Dr Nata Menabde, Dilsher Singh Kalha, Tapan Ray

Final panel discussion discussing the way forward: (L to R) Bart Janssens, Partner & Director, Boston Consulting Group; Ajit Mahadevan, Partner, Life Sciences, Ernst & Young, Moderator- K G Ananthakrishnan, Dr Rohit Shetty and Anil Varma leading to disease, disability or death, Shahani quoted a report in The Lancet, which pointed out that in the developed countries, tobacco and high cholesterol topped the list, while both these factors were at the bottom of the list for the poorest countries. These countries grappled with another set of issues, centred around deficiency of key nutrition elements like iron, zinc and Vitamin A and sanitation issues. Making the point that the state of poverty is related to the state of health, he showed a clear correlation between a country’s GDP and healthcare spend. According to him, access to healthcare had three fronts to it: find new and better treatments, making treatments available and finally, improving healthcare infrastructure. On the first front, he said, “Research-based pharma companies have a long legacy of corporate responsibility in India, with countless contributions to the improvement of health outcomes in the country. We are working every day around the clock to find new treatments and cures for society’s greatest health problems.” On the second step, he mentioned business practices like differential / innovative pricing, donations, research and development investments for tropical diseases as well as support for broader health and development goals. He projected that by improving access to vaccines, up to 10.5 million lives

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could be saved every year worldwide; four million in Africa and South-East Asia alone. Nearing the end of his presentation, he posed a provocative query: Are the poor the wards of the state or of pharma companies and hospitals? While collaborative partnerships are essential to success, Shahani stressed that the primary role of pharma companies is to develop and market high quality medicines for medical needs. While multiple stakeholders need to come together to improve access, one of the key members is the Government. Partners such as UN agencies, NGOs and others also play a meaningful role with expertise and resources.

Committed to improving health indices ... Speaking on behalf of the Government, Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Government of India admitted that the healthcare sector in India currently reflected a lack of inclusiveness. Replying to Shahani’s poser, he said the poor were the ‘wards of the state’ and while it could be agreed that the health indices could be better, he sought to correct the impression that the “Government had been sleeping”. Government systems have their inefficiencies, partly due to the multiple departments involved, and he admitted that this reality causes motiAugust 16-31, 2012

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vation levels to decrease. He spoke about the challenges presented by the wide geographical spread of the country, stressing that even if there is access, affordability remains an issue. “There have been efforts (like the National Rural Health Mission (NRHM)) and there have been results. No efforts have been spared,” he said. According to him, NRHM was a good effort as the idea was to go the grassroots but he admitted that “we need to focus on preventive healthcare”. On the drug pricing policy, Kalha gave an assurance that the Government would balance industry concerns with public health concerns, ensuring that at least the essential medicines would be affordable to the poorer sections. “I am aware that most of the industry makes efforts (to make available affordable medicines)” but he stressed that these efforts need to be enhanced. Kalha stressed that with health being one of the focus areas of the 12th Five Year Plan, the Government has adopted a more holistic approach, looking at what could be the other barriers beyond drug prices, which could involve other sectors like education, sanitation, nutrition, etc.

… as also financial protection and improving efficiency Building on the perspective provided by Kalha, Dr (Ms) Nata Menabde, WHO-India Representative, agreed that access goes beyond the health sector, but cautioned that it was premature to wait for improvement in these sectors; the health sector must improve independent of these. According to her, improving health indices is not enough; financial protection and improving efficiency is as important. Expanding this point, she said, “If the government provides effective financing to deliver services to people in a responsive way, ensures fair regulation and provides the necessary manpower, the performance will dramatically improve regarding easier access to facilities, better quality of services and higher system efficiency. This will ultimately contribute towards improved population health.” Besides financing, she stressed that governance matters and the industry needed to see policy changes from the government’s end. While pharma companies in India are key suppliers of affordable medicines, ensuring consistent quality is a key aspect. For instance, the UN’s global polio vaccination programme was

While life expectancy has more than doubled over the last century, the quality of life has not increased 30

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Kewal Handa, MD, Pfizer

Dr Shailesh Ayyangar, MD, India & VP, South Asia, Sanofi India

severely impacted when an Indiabased supplier had to withdraw its oral polio vaccines from the WHO’s list of pre-qualified vaccines, as the facility where the vaccine was being made needed further corrective actions after a WHO assessment of its quality management system. Menabde cautioned that quality of medicines has to be reliable and consistent. Alluding to current policy issues like the pharma policy, being debated, she was of the opinion that while reasonable compromises have to be made so that the end concern is met, it cannot be looked at solely from a profit margin issue. Highlighting the need for Universal Health Coverage in India, Dr K Srinath Reddy, President, Public Health Foundation of India said, “The journey towards a better healthcare system in India has begun with the Prime Minister announcing 12th Five Year Plan as the Plan for Health. The proposed increase in public expenditures on health from the current level of 1.2 per cent of GDP to at least 2.5 per cent by the end of the 12th plan, and to at least three per cent of GDP in the 13th Plan is a step closer towards realising the universal healthcare coverage 2022 vision that seeks to entitle universal health entitlement to every citizen, guarantee access to an essential health package and integrate health care delivery.” Giving the keynote address, Reddy quoted Gunnar Myrdal, the Swedish economist and Nobel Laureate: Health leaps out of science and draws nourishment from the society around it. He chose this quote to underline the connection between health, science and society, a connection that unfortunately seems to be lacking in India. He pointed out that while the country’s founding fathers had a vision for Universal Health Care (UHC) way back in 1947, we have been overtaken by many smaller nations; for instance, Sri Lanka achieved UHC in 1950. Citing more statistics, Reddy said that our current public funding of health is 1.2 per cent, lagging Sri Lanka’s 1.8 per cent, Thailand’s 3.3 per cent and China’s 2.3 per cent. Today our nation has the largest number of underweight children (42 per cent under five years). And with a current infant mortality rate (IMR) of 47 per 1000 live births and a maternal mortality ratio (MMR) of 212 per 100000 live births, Reddy predicted

that it will be a challenge to meet national goals of 27 per 1000 (IMR) or 100 per 100000 (MMR) by 2017. The HLEG’s report has since been forwarded to the state governments but sources suspect that not many state health ministers have got around to reading the 300+ pages report, much less actioning or at least deliberating on the recommendations. Or is it that many of the recommendations make them uneasy? Reddy summarised some of the recommendations in a report prepared by a High Level Expert Group (HLEG) on Universal Healthcare (UHC), of which he is the chair. For example, as part of the road map towards achieving UHC, the HLEG report suggests that all existing schemes need extensive review and may need to be brought under a central umbrella. Indeed, Reddy points out that many countries, most notably the US and UK, are cutting back or rationalising healthcare schemes that have become debt traps. The Rashtriya Swasthya Bima Yojana (RSYB), Rajiv Arogyasri of Andhra Pradesh and Tamil Nadu Health Insurance Schemes, which were indeed pioneering efforts at the time they were launched, are running out of steam (as well as funds). For example, the RSBY has become non-viable as claims have outstripped premia and the public sector insurer is reportedly threatening to walk out of the scheme if premia are not increased. Reddy also quoted from reports that schemes like the Rashtriya Swasthya Bima Yojana, Rajiv Arogyasri of Andhra Pradesh and Tamil Nadu Health Insurance Schemes do not do what they were supposed to do; i.e. reduce health spend. Studies have proved that health expenditure of poorer sections of households under these government-promoted schemes has actually risen, because such schemes do not cover outpatient care, medicines or lab tests, all of which form a larger slice of the out-of-pocket spend on healthcare. The inaugural session was followed by sessions taking forward this theme. Dr Shailesh Ayyangar, Managing Director, India and Vice President, South Asia, Sanofi India chaired a session on Improving Access to Healthcare, while Kewal Handa, Managing Director, Pfizer anchored the session on Moving Ahead in the ‘Decade of Innovation’.

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viveka.r@expressindia.com August 16-31, 2012

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Trends Exports organises seminar on EU-GMP inspection Sachin Jagdale Mumbai rends Exports recently organised a seminar in Mumbai for understanding regulatory aspects of EUGMP inspection in Europe. Discussions were held on the expectations of regulatory bodies in Europe before permitting the export of pharma Active Pharmaceutical Ingredients (APIs). Trends Exports is currently involved in export of pharmaceutical APIs, as well as transfer of technology and also as consultant to pharma companies. The seminar was conducted by Knud Ryhl, Senior Inspector, Danish Medicine Agency. Quality Assurance (QA), Quality Control (QC) and production professionals from the pharma industry attended the seminar. Knud briefed attendees over how to overcome the deficiencies which are being noted during the inspection by various European inspection agencies. Basic information of current EU Legislation, as well as what is being expected in 2013, were also discussed. Speaking on the occasion, Dr Jitendra Dwivedi, Chairman, Trends Exports said, “I am currently advising companies on EU-GMP besides getting them inspected for EU-GMP certification. The lecture by Knud was one such initiative to educate our pharma professionals about EU-GMP requirements. This seminar was scheduled over two days and on both days there was a huge turn out. We will try to organise such seminars every alternative year at various locales.” One of the attendees, Raghumitra,

(L to R) - Dr Jitendra Dwivedi, Chairman, Trends Exports; Knud Ryhl, Medicines Inspector, Danish Medicines Agency and Bharati Kale, Deputy General Manager, Trends Exports

Director, Lee Pharma said, “The seminar by Knud was fruitful for API manufacturing companies. It almost covered the complete spectrum of the quality aspects of the API manufacturing units. We look forward to have such seminars in

Hyderabad and expect huge footfalls.” During the seminar, there were question answer sessions, where participants asked Knud questions pertaining to different aspects of regulation. sachin.jagdale@expressindia.com

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August 16-31, 2012

Management

August 16-31, 2012

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INSIGHT FOR MANAGING PHARMA

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M|A|N|A|G|E|M|E|N|T TAPAN J RAY

DR AJIT DANGI

DAARA PATEL

S RAMESH

Director General Organisation Of Pharmaceutical Producers Of India

President and CEO Danssen Consulting

Secretary General Indian Drug Manufacturers Association

President Finance and Planning Lupin

In my view, limiting FDI in the pharma sector of India, at this stage, without any substantive reason and just based on unfounded apprehensions

Various government departments and ministries are sufficiently empowered under the current law to ensure that India’s sovereignty and public health are not compromised

We have had a rethink on the issue and consider that 100 % FDI could be allowed as the Indian industry needs huge investments to meet R&D costs, brand building costs, production facility costs etc.

The move to allow FDI is a positive one as there is a need to provide impetus to R&D and creating an attractive proposition for global pharma players will allow companies to do just that

he current Indian pharmaceutical market scenario has mixed availability of branded and generics. Each branded generic/generic molecule (constituting over 99 per cent of the Indian pharma market (IPM)) has not less than 50 to 60 competitors within the same chemical compound. 100 per cent of the IPM is price regulated, around 20 per cent under cost based price control as per Drug Price Control Order (DPCO) 95 and the balance 80 per cent is under stringent price monitoring with a maximum annual price increase cap being effectively in place. Comprehensive data with regard to acquisition of pharma companies by multinational companies has not been maintained by the Ministry of Commerce and Industry. However, foreign direct investment (FDI) equity inflows of $341.49 million, have been recorded, under the acquisition route, in the drugs and pharma sector, between April, 2009 to February, 2012.

The FDI in pharma debate The pharma industry is currently in the grip of a heated debate where one group pitched for relaxed FDI norms and 100 per cent FDI in pharma projects while the other group opposed these moves and recommended that only 49 per cent of FDI should be permitted in the brownfield projects of the pharma sector. The key anticipation for issue of 100 per cent FDI in the pharma sector was first raised in a discussion paper of the Department of Industrial Policy and Promotion (DIPP) of the Ministry of Commerce and Industries dated on August 24, 2010. The paper was primarily on Compulsory Licensing (CL), but the FDI issue was also duly noted and touched upon several times later. However, to understand the whole industry and its working mechanisms to review the issue properly. On October 10, 2011, Prime Minister Manmohan Singh called a meeting of the Health and Commerce Ministries to decide on whether to bring FDI in the

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pharma sector under Foreign Direct Investment Promotion Board (FIPB) for "brownfield projects". He accepted the recommendation of the ‘Maira Committee’ on FDI in the pharma sector and decided that the Competition Commission of India (CCI) will continue to scrutinise all Mergers and Acquisitions (M&A) to avoid any possible adverse impact on ‘public health interest’ arising out of such deals. It was reported at that time that the new system will be put in place within a period of six months. By the time CCI equips itself to handle the recommendations of the ‘Maira Committee’, as an interim measure, all brownfield pharma M&A proposals will be routed through FIPB for a period not exceeding six months. The existing policy on FDI, in the pharma sector, was reviewed, vide press note 3 (2011), issued on November 8, 2011, wherein FDI, upto 100 per cent, under the automatic route, is permitted for greenfield investments and FDI, up to 100 per cent, under the Government approval route, is permitted for investments in existing companies. A high-level expert panel of the Planning Commission on universal health has recommended lowering the present cap of 100 per cent FDI in pharma sector through the automatic route to below 49 per cent "to retain predominance of Indian pharma companies and preserve countries self-sufficiency in drug production.” The Planning Commission's panel has recommended that the government should strengthen PSUs. The most recent discussion on this front was on July 24, 2012 where an inter-ministerial group on FDI in pharma, headed by Shaktikanta Das, Additional Secretary in the Department of Economic Affairs (DEA), and attended by representatives of DIPP, Health, External Affairs, and Overseas Indian Affairs Ministries, deliberated on the FDI in pharma. The group has also suggested that investments resulting in an equi-

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ty holding higher than 49 per cent in an Indian pharma company will have to apply for the approval of the FIPB, a part of the ministry of finance.

Industry speak Tapan J Ray, Director General, Organisation Of Pharmaceutical Producers Of India (OPPI) persents the argument against the FDI cap saying, “With a CL, the Indian government can authorise any pharma company to make any medicine needed by the country on an emergency basis. The country has already witnessed this during the H1N1 influenza pandemic. The very thought of creating a legal barrier by fixing a cap on the FDI to prevent the domestic pharma players from selling their respective companies' products at a market driven price, just from the CL point of view, sounds unreasonable, prejudiced and highly protectionist in a globalised economy. In an environment like this, any apprehension or threat to ‘public health interest’ due to irresponsible pricing, will be highly imaginary in nature, especially when the medicine prices in India are cheapest in the world.” Rahul Sehgal, President, Nestor Pharmaceuticals disagrees with this reasoning saying, “There is nothing wrong with 100 per cent FDI participation in the pharma industry. The entry of MNCs in the generic space is a strategic shift in the business model. Consequently, acquisition of generic companies is not only a tool for implementing the strategic shift, but also a smart move to fast track their entry in the generic space— ‘the future of the strategic pharma sector.’ Acquisitions are a major tactical move and should be evaluated accordingly. It will be inappropriate to measure the impact of this profound shift by change in price levels or impact on competition in a short period.” Dr Ajit Dangi, President and CEO, Danssen Consulting gives the historial perspective on the Government’s FDI policy stating, “Indian pharma sector is August 16-31, 2012

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one of the few industrial sectors in India which is showing a healthy profitable growth not only in domestic market but also in exports consistently for the last several years. In spite of slowing global economy, rigid domestic price controls, weak enforcement of IPR, outdated drug regulatory policies and unpredictable tax environment, the sector has not only managed to survive but thrive in an intensely competitive market. But like in most democracies and more so in India, politics often drives economics resulting in a sound policy announced a decade ago of allowing 100 per cent FDI in pharma sector through automatic route being reversed by creating two categories for investment, brownfield and greenfield.” Daara Patel, Secretary General, Indian Drug Manufacturers Association (IDMA) informs, “The Government has been scrutinising the existing FDI policy relating to the pharma sector that allows 100 per cent FDI through automatic route in greenfield projects and also 100 per cent through Government approval route in brownfield projects. To this end, the Department of Economic Affairs, Ministry of Finance had set up a Special Group in May 2012 to streamline the process for approval of FDI in brownfield pharma through FIPB. Forming an opinion on the same by an apex Association like IDMA is a tough job as IDMA consists of over 700 members comprising micro, small, medium, large and very large manufacturers situated throughout the length and breadth of our country with five State Boards, who have compelling reasons and divergent views on such a delicate issue. IDMA had earlier supported a cap on FDI in

August 16-31, 2012

the automatic route. However, we have had a re-think on the issue and consider that 100 per cent FDI could be allowed as the Indian industry needs huge investments to meet R&D costs, brand building costs, state of the art production facility costs etc. “ S Ramesh, President – Finance and Planning, Lupin says, “The role of FDI in Indian pharma has been significant; however it is riddled with both pros and cons. It is important to note that the risks that come with these cons can be mitigated by creating the right policy framework. The move to allow FDI is a positive one as there is a need to provide impetus to R&D and creating an attractive proposition for global pharma players will allow companies to do just that. Given the growing set of Indian consumers, the need for innovative R&D is pressing, moreover this will be important in the quest to provide affordable drugs. It is especially important that the new policy not only safeguards the interests of existing, domestic pharma players but also that it allows all the companies, in question, to make profits.” Ray says, “It is quite intriguing, why the subject matter is being revisited after the Prime Minister’s clear decision on the issue. The pharma sector in India was opened up for 100 per cent FDI through the automatic route, only in 2002. This reformed FDI policy has been helping India as an attractive investment destination for pharmaceuticals. Any change in this policy now, will send wrong signals to the foreign investors about the unpredictability of the investment climate in India, the impact of which could be felt even beyond the

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pharma sector of the country.” “In my view, limiting FDI in the pharma sector of India, at this stage, without any substantive reason and just based on unfounded apprehensions, even when the Government is debating to open up the retail and the insurance sectors to foreign investors, will be a retrograde step in the reform process of the country,” he further states. Dangi informs, “Brownfield investments are to be routed initially through FIPB and later through CCI. Some departments are even suggesting 49 per cent cap on investment in brownfield category. The reason given for this 'U' turn is an imaginary fear that MNCs will acquire Indian companies resulting in increase in drug prices and shortage of essential drugs as MNCs may discontinue manufacture of essential drugs due to low margins resulting in increased imports thus endangering public health and competitiveness of the Indian pharma industry. Similar arguments were put forward when India enacted the product patent law in 2005 with great reluctance. But seven years after this law was enacted we find that there is no dramatic price increase or drug shortage. On the contrary, many Indian companies have doubled their R&D budgets resulting in over a dozen new drug molecules in late phase clinical trials ready to be launched in next few years. Ranbaxy, for instance, has already paved the way by launching India`s first patented new drug for malaria. Many Indian companies have also earned millions of dollars in milestone payments from MNCs by out licensing their new drug candidates for global market.” He continues, “Given the above

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M|A|N|A|G|E|M|E|N|T Deferred FDI proposals Pfizer, Mumbai

Induction of foreign equity in an operating cum investing company to carry out the business in pharmaceutical sector.

Arch Pharmalabs, Mumbai

Induction of foreign investment in an existing company engaged in the business of manufacture and sale of Active Pharmaceutical Ingredients and contract research and manufacturing services.

background, putting various policy hurdles to `regulate ` FDI in pharma sector, not only smacks of an archaic mindset of policy makers but goes against the policy of economic reforms to liberalise the Indian economy. The first question we must ask is “does India require FDI?” Given the precarious state of India`s economy, rising fiscal deficit, depletion of forex reserves, rupee approaching senior citizenship (` 60 a dollar) and now specter of deficient monsoon, India can hardly afford not to attract more FDI. Sehgal shows concerns that the regulation of FDI in pharma will impact the merger and acquisition (M&A) rules which in turn will affect the profitability as the will not be enough margins to promote. “The fear that these M&As between multinational companies and Indian pharma companies may lead to an oligopolistic market and jacking up of prices is unfounded and unsubstantial. It will be irrational for India to remove pharma sector from the automatic route and direct every brownfield FDI through FIPB route. There are other ways to provide quality medicines at affordable prices to the masses. Collaboration between the pharma companies and the government is the best way to make high quality medicines accessible to all. Any regulatory restrictions on FDI could adversely impact competition which is not in the public interest. “ Patel informs,”There is another school of thought which is concerned that the takeover of the Indian pharma companies by MNCs will mark the end of the pharma industry. Whilst we need to take care of these sentiments, let us not forget that there are over 10,000 manufacturing units churning out over 60,000 formulations. As against this there are not many multinational companies who have the resources to buy or the appetite to invest in so many Indian companies and at the same time very few Indian companies would qualify as super candidates for 100 per cent takeovers.” He continues, There is still another school of thought which says 100 per cent FDI in Indian companies would lead to increase in prices. This may not be true as the fact remains that: there is no direct connection between FDI and pricing. Pricing of a pharma product is dependent on the cost, com-

petition, margin policy, business expenses, taxation, etc. All prices vary within a range – both of Indian and MNC products. For most pharma products, fortunately, we have widespread competition and prices in India are the lowest in the world. Additionally, we have government price control/monitoring and annual ceiling on all price increases. Any regulatory restrictions on FDI could adversely impact competition which is not in public interest. In fact, FDI investment could lead to increased competition, improved technologies, facilitate local R&D, support building of Indian brands and also promote employment.” “Competition Commission could be directed to review all major M&A pro-

posals to ensure and pacify our concerns that monopolies are not created by the takeovers thus influencing competition and price rises. This along with constant price monitoring by NPPA would adequately protect the consumer interest. “We also have a strong democracy and most Parliamentarians are sensitive enough not to allow monopolistic situations and consequent abnormal price increases especially in pharma products However, the Government should allow 100 per cent FDI only with certain safeguards and riders,” Patel adds. Ramesh adds, “Overall, while the finer details will have to be carefully articulated so as to not prompt takeovers of Indian pharma companies, allowing FDI in the Indian pharma sector has the potential to create tremendous growth for the industry at-large, which is well poised to ride this wave. Dangi suggests, “There are sufficient checks and balances to ensure that anticompetitive practices do not affect the

growth of the domestic sector and public health is not affected. With over 10,000 manufacturers and every generic brand having over 20 me too brands available, the market is highly cluttered. Even the market leader has less than seven percent market share. A little consolidation, therefore, will not hurt the industry. Also, various government departments and ministries are sufficiently empowered under the current law to ensure that India's sovereignty and public health are not compromised. There is also a principle of reciprocity in today's interconnected economy. When Indian companies can go abroad and acquire 100 per cent stake in a company , there is no reason why India should not reciprocate. To sum up, by creating a positive investment climate, India will not only attract more FDI but it will help in getting modern technology, efficient logistics and supply chain, increased employment opportunities to our highly skilled knowledge workers and provide access to international markets.” He summarises, “Let us see the total FDI attracted by BRICS countries in 2011 - China $124 billion, Brazil $67 billion, Russia $53 billion. and India $32 billion. The Indian policy makers from various departments like MOH, DOP, DIPP, FIPB, CCI should keep their differences aside and instead of appointing 'n' number of committees and Group of Ministers (GoM) ruminating on the issue endlessly, continue the sound policy of 100 per cent FDI through automatic route in the pharma sector.” Thus, the general consensus among the industry players is that restricting FDI in pharma is a very over-protective stance and will be detrimental to the sector's progress. Pranab Mukherjee, the President of India had once during his tenure as the Finance Minister stated, “Protectionism is harmful”. He had said this in context of the US move to hike visa fees and clamp down on outsourcing. The pharma players are of the opinion that we are also guilty of the same thing as far as FDIs in pharma are concerned. The government is still mulling over the proposal to restrict FDI in India. The verdict on the whole issue still pending, and the final decision rests with the PM. The industry exists in the hope that the final vote would be cast in their favour. u.sharma@expressindia.com

Approved FDI proposals

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Name of the applicant

Particulars of the proposal

Sun Pharma Research Company Limited, Mumbai

Induction of foreign equity by way of issue of partly paid 10.00 up shares to carry out the development of new proprietary drugs

Mozart Limited, Mauritius

Induction of foreign investment in the existing company in the pharmaceuticals sector (brownfield investments)

300.00

Plethico Pharmaceuticals Limited, Mumbai

Issue of foreign currency convertible bonds to carry out the business of drug discovery and development

500.00

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FDI/NRI inflows (` in crore)

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M|A|N|A|G|E|M|E|N|T DOCTOR FACTOR

Epilepsy: More awareness needed Many in India suffer from epilepsy and there are many who require treatments to overcome this disease. Express Pharma, in association with Majestic MRSS, gives an outlook about the awareness level among the medical fraternity and patients and the myths related to it pilepsy is a brain disorder where a person has repeated seizures (convulsions) over time. Seizures are episodes of disturbed brain activity that cause changes in attention or behaviour. The brain uses electro-chemical energy and any disruption in the electrical process in the brain can cause abnormal activity. This leads to epilepsy where nerve cells in the brain misfires and create abnormal electrical activity. People suffering from epilepsy have seizures that happen repeatedly.

Causes

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The word epilepsy has been coined from a Greek term which means 'to possess, seize or hold.' Famous people who suffered from the disease were Julius Caesar, Russian Czar Peter the Great, and Pope Pius IX, to name a few. People suffering from the disease are viewed with fear, suspicion and are subjected to social stigmas.

Common Causes

Facts and figures According to the Indian Epilepsy Association, around 10 per cent of the population in India suffers from epilepsy, which is a significant number as against an average population of one billion. However, this disease is not considered as major a health threat as HIV or tuberculosis. Studies conducted across India among 30 neurologists/neurosurgeons, spread across these six citiesâ&#x20AC;&#x201D;Delhi, Mumbai, Bangalore, Chennai, Kolkata and Hyderabad, indicate that the problem varies from 9/1000 in Bangalore, 5/1000 in Mumbai, 3/1000 in Kolkata and 4/1000 in Delhi. As per World Health Organisation figures, 70-80 per cent patients do not receive treatment. Epilepsy is a lifelong condition for many people. There is a very low risk of

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sudden death with epilepsy. However, serious injury can occur if a seizure occurs during driving or when operating equipment.

Causes According to a neurologist in Delhi, it is not possible to know the exact cause of epilepsy. A neurologist from Hyderabad admits that 75 per cent of the time, doctors do not know the exact cause of the tumour, it could be anything from alcohol withdrawal to a worm infectionâ&#x20AC;?.

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M|A|N|A|G|E|M|E|N|T INSIGHT

A new sobriquet for SMS service-Substituted Medicine Service B Sriram, Executive Director–Healthcare, Direxions Marketing Solutions expounds his views on SMS service being utilised to give alternatives for medicine prescribed by doctors recent article in a leading newspaper talked about a novel method of how technology can be leveraged to get the “best price” for the medicines prescribed by your doctor. Interesting. Apparently, come August 2012, if you have been prescribed a particular brand of a drug by your doctor/physician, you can send an SMS to a predestinated number from your mobile and you will receive two to three options of the same medicine, along with the price differential. Sources said that all responses would come with a caution: ie. Consult the doctor before consuming the alternative medicine. The first question which comes to mind is, who drives this ` 54,000 crore market and who are the decision makers? Is it the doctors, pharmaceutical companies, distributors or patients? As per Drugs and Cosmetics (2nd amendment) Rules 2006, all drugs sold under the purview of schedule H need a doctor’s prescription. It would thus be fair to state that the doctor is the decision maker. If one visits the site www.drugscontrol.org/Schedule_H.pdf, there are 536 schedule H drugs listed. Imagine if for every drug prescribed by a doctor, two or three alternatives are provided as per the claimed SMS service, we are talking of around 1500 alternatives at the very least! There are always two sides to a coin. Let’s analyse the pros and cons if an SMSbased system as above comes into effect

Pros 1. You are no more obligated to purchase your medicines as per doctor’s prescription. You can decide on a suitable alternate to the brand prescribed; recheck with your doctor and save valuable money. 2. In case the brand prescribed is not available at your nearby chemist, this system will allow you to choose an alternative thus ensuring compliance of medication. You need not feel stressed and waste valuable time hopping from one medical shop to another enquiring about availability of the brand prescribed by your doctor.

3. The pharmacist begins to play a bigger role since you as a customer are open to “substituting” the prescribed medicine and he could suggest some more cheaper options beyond those received through the SMS system. 4. Many corporate hospitals which insist that medicines be purchased only from their pharmacy might have to keep a bigger range of alternatives in order to cater to patients’ demand, else they might lose patients who are likely to shift to another hospital which stocks a wider range. 5. The system offers an excellent platform for engaging you in valuable direct marketing initiative. An extended service could be that the system provides you value added information about the product you are taking, such as side effects, contraindications, drug interactions which your doctor may not explain to you. A logical counter point could be why the doctor doesn’t always inform all about the above? Maybe it takes a lot of a doctor’s time in explaining and he/she would much rather use that time to see a few more patients and keep the coffers ringing. 6. Targeted marketing: The database that will be created across India through this service is estimated to be huge. If you are suffering from a serious ailment and are looking for similar patient support group for seeking opinion and emotional support, the system could put you through a similar group with whom you can exchange notes and receive inputs and comfort.(like the successful cancer patient group) 1. The newspaper article mentions that all responses would come with a caution: to consult the doctor before consuming the alternate medicine. Imagine the time you and the doctor would have to invest in clarifying doubts. Will your busy doctor have the time and inclination to attend to all such calls? Doubtful. 2. Who will guarantee the quality of the cheaper alternative which you will be

consuming? 3. If you suffer from any adverse reaction which could be attributable to the substituted medicine you consumed, the next time around would you be able to go back to the same doctor who wrote his brand of choice in the prescription for you. Probably not. Which means every time you buy a cheaper alternative to the brand prescribed by your doctor, it would be time to find a new doctor as some trust deficit might have developed between the doctor and you . 4. The doctor community as also health insurance policies might start to incorporate disclaimers in their prescriptions and forms respectively against substitution. 5. Most people with chronic ailments require multidrug treatment. Let us take a situation (quite common in India) where a person is suffering from hypertension, high cholesterol, arthritis, diabetes and hypothyroidism. If the SMS service provides three alternates for each of the medication prescribed, it can be a tough task for patients to decide on the best alternative for each ailment. Given that any single SMS can have 160 characters, it will have to be multiple messages. It is also not clear as to who pays for the SMS and the price thereof for each SMS. 6. If it is established that death occurred due to the medicines consumed (as per the SMS service), what would be the legal process? How will the next of kin be compensated and by whom? 7. Given the extent of corruption in India, it is quite possible for a local pharma company to influence the system in incorporating their brands in the system. How does one prevent this scam? There is no doubt that the medical professionals will continue to play an integral part of this multi-billion dollar industry, it may be counterproductive to introduce this system, but then again no harm in seeking another opinion…SMSbased maybe !! The views expressed in this article are personal. The author can be contacted at bsriram@direxions.com

infection, tumours/lesions, or any kind of head injury (both physical and emotional). Although scientifically, doctors cannot say that there is any particular age group which is more prone to epilepsy, however, they have seen a pattern where younger children represent a high percentage of the epileptic population. Most doctors believe that children are more easily susceptible to parasitic infections of the central nervous system and genetic mutation, which usually happen during the foetal stage. According to another neurologist in Delhi, “During the creation of the brain, neurons are formed around fluid filled cavities called ventricles located at the centre of the brain. As a baby's brain

develops, these genetically programmed neurons travel out in different directions to take over their respective tasks such as speech, motor functions, reasoning etc. When a certain band of neurons fails to travel to its targeted destination, it causes hindrance in the normal electrical circuitry of the brain, producing an abnormal current pattern causing seizures." It has been noted that in 70-80 per cent cases, the seizures could be controlled with the help of medication. In the remaining 20 per cent, the most common treatment protocol used is surgery. Out of this 20 per cent, which are unresponsive to medication it was found that a ketogenic diet (a high-fat, adequateprotein, low-carbohydrate diet) was use-

Cons

Epilepsy: More... A neurologist from Mumbai commented, “The most common type is idiopathic epilepsy; six out of 10 people suffer from this disorder. However, it has been noted that the most common type of epilepsy was caused by HypoxicIschemtic Encephalopathy, parasitic Tests

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August 16-31, 2012

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ful. A ketogenic diet helps to force neurons to switch from their customary fuel of glucose to a type of fat by-product called a ketone body. General practitioners have a vital role to play in the treatment of this malady which continues to be shackled in myths and misconceptions, according to a majority of the neurologists interviewed. Stressing the importance of general practitioners, they say that they are also better placed to change the attitudes of families and treat patients. Experts have repeatedly emphasised that it is not contagious and people with epilepsy are not crazy. A consulting neurosurgeon from Delhi explained that seizures and epilepsy are not synonymous. He said, “A single seizure can occur in up to eight per cent of the population during ones lifetime. Only seizures that are recurrent and not caused by any particular stimulus like high fever, alcohol withdrawal or even low blood sugar can be termed as epilepsy.”

ication should come with pamphlets which give facts about the disease and give importance to compliance and regular checkups. If pharma companies are unable to counsel patients they should atleast guide them in the right direction, say, for example, inform them about Indian Epilepsy Association (IEA).” IEA looks after the non-medical and social aspects of epilepsy while the Indian Epilepsy Society (IES) is

responsible for the medical aspects. Other common popular initiatives are to conduct free camps not only for the patients but for their family members in order to ensure that they too get to know about the disease. This should not be limited only to urban India, but it needs to reach the grassroots. Similarly, the government needs to follow its own footsteps, undertake campaigns similar to those for tuberculosis and HIV.

Disclaimer Statements and opinions expressed in this article are those of doctors across urban cities(Delhi, Mumbai, Hyderabad, Chennai, Kolkata, Bangalore). While every care has been taken in the compilation of this information, the authors will not be responsible for any claim, loss, damage or inconvenience caused as a result of any information within these pages.

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Myths I. Epilepsy occurs due to incarceration with evil spirits II. Patients are possessed by God, they should be worshipped III. Having a person in the family with epilepsy is a stigma, so this fact should be concealed IV. Children with epilepsy are dull and cannot learn, so they should not be sent to school. V. Women with epilepsy can never have children, so they should not get married. VI. A seizure can be terminated by putting a key in the patient’s hand or by making the patient smell onions or a dirty shoe.

According to a neurologist in Delhi, “Although the first line drugs are affordable, the second line drugs are expensive which leads to drop in compliance. Even getting a test done is expensive for some patients where they are unable to get the proper treatment. The media should play an important role in creating awareness about epilepsy which will help patients become less hesitant and get cured.

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Role of pharma companies Neurologists and neurosurgeons across India believes that with more active participation from pharma companies and the government both, would help reduce the number of patients who do not get treatment. For example - pharma companies could keep flyers in the offices of general practitioners to ensure mass communication, as well as materials for the doctors in order to ensure that the cases are caught at the earliest stage possible, suggests a neurologist in Hyderabad. A Bangalore-based neurosurgeon advocated, “All medAugust 16-31, 2012

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Sanofi Pasteur’s dengue vaccine demonstrates proof of efficacy Early data analysis confirms excellent safety profile and shows ability to protect against disease Lyon, France anofi Pasteur, the vaccines division of Sanofi, has announced that its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, a threat to almost three billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety. The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of the four virus serotypes circulating in Thailand. Analyses are ongoing to understand the lack of protection for the fourth serotype in the particular epidemiological context of Thailand. Results of this first efficacy trial with Sanofi Pasteur’s dengue vaccine candidate represent a key milestone in the

quest to develop a safe and efficacious human vaccine against dengue. This is also an important development for global public health, since there is currently no specific treatment or prevention for dengue. We are fully committed to making dengue a vaccine preventable disease by bringing a safe and effective vaccine to people living in endemic regions of the world,” said Michel De Wilde, Executive Vice President, Research and Development, Sanofi Pasteur. Importantly, the results confirm the excellent safety profile of the vaccine candidate. The full data resulting from this first efficacy trial are currently under review by scientific and clinical experts, as well as public health officials. Detailed results of this study will be published in a peer-reviewed journal and presented to the scientific commu-

nity later this year. Large scale phase III dengue vaccine clinical studies with 31,000 participants are underway in 10 countries of Asia and Latin America. These studies will generate important additional data in a broader population and in a variety of epidemiological settings to demonstrate vaccine efficacy against the four circulating dengue virus serotypes. The study was conducted in 4,002 children aged 4 to 11 years, in partnership with the Mahidol University under the patronage of the Thai Ministry of Public Health in Muang district of the Ratchaburi Province. Sanofi Pasteur dengue vaccine candidate is a live attenuated vaccine. The vaccination schedule is three doses given six months apart (at zero, six and 12 months). EP News Bureau

Population Genetics validates GenomePooling for Cancer The method is sensitive and accurate enough to detect small percentages of gene variants within cancer tissue Cambridge, UK opulation Genetics Technologies, creator of innovative methods for genetic analyses and biomarker discovery, has successfully completed a pilot study to prove that its GenomePooling method is sensitive and accurate enough to detect even small percentages of gene variants within cancer tissue. This validates the method’s suitability for use in IntReALL 2010, the world’s largest genetic analysis of acute lymphoblastic leukaemia (ALL) relapse cases. ALL is the most common childhood malignant disease. Cancer tissues are problematic because they can contain multiple tissue types and multiple cancer variants that may respond differently to treatment. Being able to identify associations between genotype and treatment responsiveness matters because, if a tumour contains highly drug resistant variants, or the patient has a genetic predisposition to relapse, alternative treatments may be appropriate. In order to demonstrate their ability to detect variants in mixed tumour tissue, Population Genetics mixed two different DNA samples and showed using their novel molecular counting technology that they could identify variants with high sensitivity. The pilot compared data derived by Population Genetics from ALL patients and cell-line derived samples with data generated in a parallel study. The par-

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allel study was undertaken by Dr Julie Irving, Reader in Experimental Haematology at Newcastle University, who used the conventional mutational screening method, called DHPLC (denaturing high-performance liquid chromatography). Julie said, “Our comparative study showed that Population Genetics’ methodology is accurate, more sensitive and thus superior to the standard DHPLC method. This gives us confidence that it is the right workflow to use for interrogating data from the large population IntReALL study which is just getting underway.” Population Genetics sequenced 28 discrete genomic regions across a total of 50 human genomic DNA samples, 40 derived from patients suffering ALL and 10 derived from cell lines containing a mix of mutated and wild type phenotypes of two known genes. The Population Genetics method identified all the known mutations and an additional five that were not detected by DHPLC; these novel variants were then confirmed by Sanger sequencing and allele specific polymerase chain reaction. All affects four per 100,000 children per year in Europe but intensive combination chemotherapy with stem cell transplantation has improved survival from under 20 per cent in the 1970s to over 80 per cent today. However, treatment is complex and prolonged and it is unclear why some children do not respond to, or relapse after, existing

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treatments. IntReALL 2010 comprises 23 research teams, led by Vaskar Saha, Professor of Paediatric Oncology at The University of Manchester, gathering DNA across Europe, Japan, Israel and Australia from children who have relapsed after treatment for ALL. Funded by IntReALL’s EU FP7 grant, Population Genetics will study the resulting biobank of leukaemia samples using proprietary GenomePooling workflows to identify and validate associations between genetic risk factors and treatment efficacy. It is hoped that the IntReALL study will aid in the optimisation of therapy based on genetic stratification and allow randomised controlled trials of potential new drugs. Alan Schafer, CEO, Population Genetics, commented, “Accurately and sensitively detecting genetic variants in large numbers of samples is critical for developing genetic biomarkers for cancer. For this collaboration we created a version of GenomePooling suited to the study needs, and have established cancer as another application in which our population-scale genetic analysis methods have demonstrated their utility. Our approach enables the generation of statistically rich information from thousands of genomes with resolution down to the level of the individual. We look forward to working with the IntReALL consortium to potentially improve treatment outcomes for children suffering ALL.” EP News Bureau August 16-31, 2012

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Scottish scientists find ways to cure sleeping sickness & brain cancer The new medication will be used to treat diseases caused by parasites such as T brucei discovery by experts at the Universities of St Andrews and Edinburgh has opened the door to a potentially revolutionary way of treating sleeping sickness and childhood brain cancer. Existing treatments for these illnesses, known as 5-nitrofurans, can for some patients have severe side effects which often force patients to give up the medication. Now, a joint team of scientists at St Andrews and Edinburgh has discovered the cause of these crippling sideeffects, opening a path to creating a new treatment within a few years. The research team has proposed an alternative drug combination which could be more effective with fewer side-effects. Dr Nick Westwood, Reader in Chemistry and Chemical Biology at the University of St Andrews, said, “We have listened to the message sent by patients. The class of drugs that includes Nifurtimox is effective but many people struggle to complete the course of treatment due to the serious side effects. Our collaborative work with Dr Elizabeth Patton at the University of Edinburgh leads to a potential solution to this problem which we believe should be trialed in the clinic as soon as possible.”

August 16-31, 2012

Dr Liz Patton, Group leader in the Institute of Genetics and Molecular Medicine at the University of Edinburgh said, “This is a big step forward for understanding how 5-nitrofuran drugs work, and gives us a realistic window of opportunity to help improve available treatments. Our next step is to test the effects of this combination treatment in human cells and tissues.” Nifurtimox is currently in clinical trials for childhood cancers, neuroblastoma and medulloblastoma. It is also used mostly to treat Chagas disease and has recently been introduced as a treatment for Sleeping Sickness in combination with eflornithine. The team took a radically different approach to treating diseases in the five-year study. Rather than creating a new drug from scratch, they have developed a detailed understanding of how the side-effects of a known drug arise. This has allowed them to open the door to a potentially revolutionary way of improving the treatment of diverse diseases. Dr Terry Smith, Reader in the School of Biology at the University of St Andrews, who contributed to the project, said “This new therapy combination should allow

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more patients to continue with the treatments which could save their lives. This combination will be more effective meaning patients will have an improved prognosis and treatments will be more cost-effective.” Parasitic diseases, African Sleeping Sickness and Chagas Disease in South America, are regarded as “neglected diseases” as current treatments have changed little in 60 years and are often too expensive, hard to administer and can be highly toxic for victims. On occasion patients can be killed by the medication before the disease. In SubSaharan Africa there are 70 million people at risk of Sleeping Sickness and current World Health Organisation (WHO) figures show that at least 30,000 die each year. In South America, there are more than 100 million people at risk of Chagas disease with between 1-2 million people infected at any one moment. Linna Zhou, one of the lead authors said, “This has been a really exciting collaboration to be involved in and we hope our research will have an enormous human and economic effect on the regions which are blighted by these terrible illnesses.” EP News Bureau

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New research could increase blood supplies for transfusions This discovery could dramatically boost the blood supply available for transfusions Durham, NC team of scientists from Albert Einstein College of Medicine in Bronx, NY, has developed methods to increase the production of red blood cells from stem cells, a discovery that could dramatically boost the blood supply available for transfusions. In the latest issue of STEM CELLS Translational Medicine, researchers Eric Bouhassira, Emmanuel Oliver, and Caihong Qiu published data on a promising new method of growing red blood cells in the lab. Using human stem cells from sources such as cord blood and circulating blood as well as embryonic stem cells, they produced a much higher yield of red blood cells than has previously been possible. “We combined different cell expansion protocols into a ‘cocktail’ that increased the number of cells we could produce by ten to 100 fold,” Bouhassira said. Blood transfusions, developed more

than 80 years ago, are essential component of many surgeries, trauma medicine, and blood cancer therapies, and are one of the primary treatments for people with sickle cell anemia and other blood diseases. However, the blood needed for such transfusions is obtained only through donations and can be in short supply, particularly for chronically transfused people who require rare blood groups. The methods described by the researchers can be used to produce blood with any blood groups. “The ability of scientists to grow large quantities of red blood cells at an industrial scale could revolutionise the field of transfusion medicine,” Bouhassira said. “Collecting blood through a donation-based system is serving us well but it is expensive, vulnerable to disruption and insufficient to meet the needs of some people who need ongoing transfusions. This could be a viable long-term alternative.” More than 1010 cRBCs can now be produced using a single plate of ES cells.

Combining all the known expansion methods might lead to an additional one to two orders of magnitude increase in the number of cells that can be produced from a single plate of hESCs. Therefore, production of the CD34+ cells necessary to feed bioreactors capable of producing hundreds of units of red blood cells per weeks could be done using relatively low numbers of pluripotent stem cells. “Being able to produce red blood cells from stem cells has the potential to overcome many difficulties of the current system, including sporadic shortages,” said Anthony Atala, Editor of STEM CELLS Translational Medicine and Director of the Wake Forest Institute for Regenerative Medicine. “This team has made a significant contribution to scientists’ quest to produce red blood cells in the lab.” This work was funded in part by NYSTEM, the funding agency of New York State Empire Stem Cell Board. AlphaMed Press

Queen’s University Belfast makes significant cancer breakthrough A major breakthrough by scientists at Queen’s University Belfast could lead to more effective treatments for throat and cervical cancer he discovery could see the development of new therapies, which would target the non-cancerous cells surrounding a tumour, as well as treating the tumour itself. Researchers at Queen’s Centre for Cancer Research and Cell Biology have found that the non-cancerous tissue, or ‘stroma’, surrounding cancers of the throat and cervix, plays an important role in regulating the spread of cancer cells. The discovery opens the door for the development of new treatments which, by targeting this non-cancerous tissue, could prevent it being invaded by neighbouring cancer cells. The research, led by Professor Dennis McCance, has just been published in the European Molecular Biology Organisation Journal. Professor

By specifically targeting pathways controlled by the Rb protein, it would be possible to switch-off the messages that encourage cancer cells to invade, and inhibit the spread of the tumour

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McCance said, “Cancer spreads as the result of two-way communication between the cancer cells in a tumour and the non-cancerous cells in the surrounding tissue. “We already know that cancer cells are intrinsically programmed to invade neighbouring healthy tissue. But the cells in the non-cancerous tissue are also programmed to send messages to the cancer cells, actively encouraging them to invade. If these messages — sent from the healthy tissue to the tumour — can be switched-off, then the spread of the cancer will be inhibited. “What we have discovered is that a particular protein in non-cancerous tissue has the ability to either open or close the communication pathway between the healthy tissue and the tumour. When the Retinoblastoma protein (Rb) in non-cancerous tissue is activated, this leads to a decrease in factors that encourage invasion by cancer cells. And so, the cancer doesn’t spread.” The Rb protein is found in both cancer and non-cancerous tissue. Its importance in regulating the growth of cancer cells from within tumours is already welldocumented, but this is the first time scientists have identified the role of the Rb found in healthy tissue, in encouraging or discouraging the spread of cancer. The research was conducted using three-

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dimensional tissue samples, grown in Professor McCance’s lab, to replicate the stroma tissue found around cancers of the throat and cervix. Professor McCance continued, “Current treatments for cancer focus on targeting the tumour itself, in order to kill the cancer cells before they spread. This discovery opens the door for us to develop new treatments that would target the normal tissue surrounding a tumour, as opposed to the tumour itself. By specifically targeting pathways controlled by the Rb protein, it would be possible to switch-off the messages that encourage cancer cells to invade, and inhibit the spread of the tumour. “Our research has focussed on cancers of the throat and cervix. But it is possible that Rb or other proteins in the healthy tissue surrounding other types of cancer, may play a similar role in regulating the spread of tumour cells. Therefore, the implications of this discovery could go far beyond throat and cervical cancer, and that is something we plan to investigate further.” The research was funded by the Wellcome Trust, the Experimental Cancer Medicine Centre and the National Institutes of Health (US), and was supported by the Northern Ireland Biobank. EP News Bureau August 16-31, 2012

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Lovely Professional University’s patent published in 140 countries Signs up MoU with pharma company Rhydburg for further development of product and to introduce it in market he School of Pharmaceutical Sciences of Lovely Professional University (LPU) has got their patent (PCT) published in 140 countries for the development of Targeted Release Microsphere of 5-FU (5-fluorouracil) vide Publication No. WO/ 2012/035561. This new technology is useful in overcoming the side effects of the drugs used in treatment of colon cancer and has been developed indigenously by the dean, faculty of Applied Medical Sciences, Dr Monica Gulati and her team at LPU. Realising the potential of the invention, an MoU has been signed between LPU and a premier pharmaceutical company Rhydburg at Dehradun in India. Rhydburg is one of the top manufacturers and exporters of pharmaceuticals-tablets, injections, beta lactam, syrups, capsules etc. Extending felicitations to Gulati and her team from university’s School of Pharmaceutical Sciences for their remarkable achievement, Ashok Mittal, Chancellor, LPU said, “The research facilities at the University are being extended to aim at the world class innovations and research in the university. The present patent which has already been published for 140 countries has further motivated us to perform better.” He added, “During severe medical treatments, certain side effects of many medicines have claimed human lives, leading to an incalculable precious drain on human talent and resources. This development is indeed a great endeavour towards welfare of humanity.” Speaking in this context, Ashok Monga, Director, Rhydburg said, “With team of LPU coming out with such a needed medicine, we can eas-

ily make out that India is fast realising its intellectual potential and the next era will see a lot more technological advancements from Indian scientists like those at LPU.” Highlighting the importance of the anti-cancer medicine Gulati explained more

about the side effects of colon cancer treatment. She informed, “The side-effects depend on the type of treatment and differ from person to person. In general, anticancer drugs affect cells that divide rapidly especially blood cells, cells in hair roots

and cells that line the digestive tract. When drugs affect these cells, patients are more likely to get infections, bruise, hair loss, poor appetite, nausea, vomiting, diarrhoea, mouth and lip sores or feel very weak and tired. Almost similar effects can occur dur-

ing radiation and biological therapy. However, many of these side effects of colon cancer chemotherapy can be controlled with drugs. For this reason, our department strived to invent the remedy.” EP News Bureau

This new technology is useful in overcoming the side effects of the drugs used in treatment of colon cancer August 16-31, 2012

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Pharma Technology Review

Water, an universal solvent, is an integral commodity in the pharmaceutical industry. SACHIN JAGDALE analyses various grades of water and technologies deployed to process them for use in the pharma sector

egulatory requirements put big emphasis on water quality standards that are being deployed in the pharma manufacturing facility. Water plays multiple roles in the pharmaceutical industry. It can act as an excipient or can be used during synthesis. It also has an application in the reconstitution of products or as a cleaning agent to rinse vessels and various equipments. Pharma industry implements different process technologies to turn water into required usable forms.

Water grading The pharma industry demands differ-

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ent grades of water to be used depending upon the type of operation. “Quality standards differ by application use. For many APIs that are used in oral dosages, the requirement is for potable water conforming to WHO standards. However, API that is used in parenteral applications require a more stringent specification of purified water. Products such as nasal preparations, tablet coating and granulation also require purified water. Injectables and vaccines have their own specifications which falls under “Water For Injection quality (WFI).” Quality-conscious customers and regulatory agencies are spending larger portions of their audits

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Quality-conscious customers and regulatory agencies are spending a larger portion of their audits inspecting water purification systems since it’s an important component of the manufacturing process. S.B.M.P. Halakatti Corporate QA & RA Head Granules India

inspecting water purification systems since it’s an important component of the manufacturing process,” informs SBMP Halakatti, Corporate Quality Assurance (QA) and Regulatory Affairs (RA) Head, Granules India. Amit Doshi, Director, High Purity Water and International Operation, Doshion Veolia Water Solutions (DVWS) says, “Water and air are the two most critical utilities for the pharma industry, and water is often seen as the biggest raw material as well. Thus all pharma industries are highly concerned about water quality across all applications in their consumptions.” He adds, “Globally; there are few pharmacopoeia like US pharmacopoeia, European pharmacopoeia; Japanese pharmacopoeia, Indian pharmacopoeia etc. which are followed for manufacturing of vaccines; syrup and tablets. Yes, some norms vary depending on the products and the country it is to be exported. As per the latest United States Pharmacopeia (USP)32, the parameters for purified water are 1. Conductivity: <1.3 ms/cm @ 25° C 2. Total Organic Carbon (TOC): <500 ppb. 3. Microbial: <100 cfu/ml, whereas for WFI, the specifications are more stringent.” DVWS is a joint venture between India’s leading water management group Doshion and Veolia Water Solutions & Technologies. DVWS provides complete water management services for pharma industries. Different grades of water quality

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Amit Doshi Director High Purity Water and International Operation Doshion Veolia Water Solutions (DVWS)

are required depending on the route of administration of the pharma products. According to S Sankara Rao, General Manager, Quality Management, Indian Immunological Limited (IIL), companies wishing to supply multiple markets should set specifications that meet the strictest requirements from each of the relevant pharmacopoeias. Rao says, “Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern. Water is used on demand and hence not subjected to testing and batch or lot release before use, therefore has to meet specification “on demand” when used. Micro test results require incubation periods.

Other usages of water Though water has major applications in manufacturing there are many other areas where its use proves critical. According to Kishor Datar, Chief Technical Officer, Technolutions Projects, water is predominantly used in cleaning. “Today, clean in place (CIP) are the norms used and water is extensively used for this,” informs Datar. Doshi adds few more usages of water in the pharma industry, “Besides manufacturing, water is used as utility (boiler and cooling tower make-up, heat exchanger), reactor’s cleaning, drinking, horticulture, gardening, and other general purposes.” According to Halakatti, water has a use in quality control while analysing raw materials

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Many steps are followed to process water. They mainly depend on input water quality and out-put quality expected. Various treatment schemes like CLO2/Cl2 dosing, De-Ionisation/Carbon Bed/Multi Grade Filtration/Softener/UF/RO/EDI/ Multi Column Distillation/Vapor compression distillation etc. are used Kishor Datar Chief Technical Officer Technolutions Projects

and finished goods.

Processing technology An usage of water varies depending on its application and different processes are implemented in the pharma industry to treat it. Treating water is an extensive process and involves several stages. Every pharma company will have a dedicated water treatment plant. Halakatti describes in detail the steps involved in water treatment, “First, there is a pretreatment phase where water is filtered and processed through carbon treatment. After that, water is de-mineralised to remove hard minerals in the water. Next water goes through reverse-osmosis, which is a way to desalinate the water. Afterwards, water goes through UV treatment to remove microorganisms. Finally, water goes through electrodeionisation (EDI) which removes ion.” According to Halakatti, while there are several complex steps, the takeaway is that water treatment is an exhaustive process. Water treatment is a critical step in the manufacturing process and if it is not done properly, it can lead to multiple quality issues. Doshi informs, “All validation protocols starting from design qualification, installation qualification, operational qualification and finally performance qualification are being followed before purified water is qualified for use in manufacturing process.” Datar explains, “Many steps are followed to process water. They mainly August 16-31, 2012

P|H|A|R|M|A| T|E|C|H|N|O|L|O|G|Y| R|E|V|I|E|W depend on input water quality and out-put quality expected. Various treatment schemes like CLO2/Cl2 dosing, de-ionisation/carbon bed/multi grade filtration/softener/UF/RO/E DI/multi column distillation/vapour compression distillation etc. are used.”

Effluent recycling Chemicals are widely used in the pharma industry. They are also an important constituent of the effluents. These effluents are hazardous to the environment. There are provisions to treat this water to minimise or to avoid the damage to the external environment. If effluents can be recycled and reused, it will save water and money as well as make the company more environment friendly. “There are several ways to treat water including aeration technique, trickling filtration, evaporation and chemical treatment. Many companies do basic treatment and send effluents to a common treatment plant for safe disposal,” says Halakatti. He highlights that effluent treatment is critical, and many customers, particularly in the regulated markets, demand to know that their suppliers are treating waste water and safely disposing it. He adds, “Water usage efficiency will become more critical in the future which is why Granules’ API R&D team is working on nextgeneration manufacturing processes which will improve yields and reduce effluents.” Doshi says, “Effluent treatment is varying from customer to customer but looking at the water scarcity and reliable unique technology available now in India most of the pharma compa-

nies are now going with recycling.” DVWS offers various anaerobic and aerobic technologies specially for the treatment of high organic (Biological Oxygen Demand (BOD), Chemical Oxygen Demand (COD), Total Organic Carbon (TOC)) pharma waste water. These technologies are well proven and widely used in majority of leading pharma companies across the globe. “When it comes to recy-

cling, yes it (water) can certainly be recycled with the proper tertiary treatments and used for the various utility applications like gardening, flushing and cooling tower make up. In fact we have very unique installations in India, already in operation, offering total water management concept up to zero liquid discharge, thereby enabling less water consumption and also effluent discharge/environmen-

tal hazards,” informs, Doshi. According to Rao, waste water is treated using Effluent Treatment Plants (ETP). Industries/regulations are now moving ahead with new generation ETP’s with zero discharge of effluents. Vaccine manufacturing plants use kill tanks (to decontaminate live bacteria, recombinant bacteria and virus cultures {post inactivation}) before ETP. Also

sewerage water treatments (STP’s) are in place in the industry. Pharma industry is a place where innovation is the norm. In the coming future, various new products will be discovered/introduced globally and in India. While medicines are undergoing evolution, water processing technology will also complement the wave of change. sachin.jagdale@expressindia.com

While medicines are undergoing evolution, water processing technology will also complement the wave of change

August 16-31, 2012

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Fundamentals of water systems The pharmaceutical industry today is concerned about water treatment, purification steps and high technology unit operation systems. However, it is essential to understand water from its basics. Kishor Datar, Chief Technical Officer, Technolutions Projects, talks about the fundamentals of water as molecule and its behaviour in various situations n any compound the number of protons is equal to the number of electrons; it would appear that all compounds are electrically neutral. But, that is not always the case. One end of the water molecule is slightly negative and the other end is slightly positive. Water possesses some unique properties because of its molecular structure. The polarity of water allows it to line up with itself (positive end to negative end, a chemical property called hydrogen bonding) as well as with other polar molecules. For this reason, ice is lighter than water, which causes it to float over liquid water. Water is the only molecule that behaves this way. Hydrogen bonding plays an important role in many water purification processes. All polar compounds will generally dissolve other polar compounds. This applies to water as well it being a polar compound. However, such polar compounds will not dissolve non-polar compounds like oil. Let us take a look at this simple experiment: Get a thin stream of water flowing from a faucet. Build up a static charge on a plastic comb or plastic pipe by rubbing it briskly on a silk cloth. Hold it near the stream of water. The charged comb / pipe will actually deflect the stream of water. The above experiment clearly indicates that although it is a stable molecule, water has polarity and hence gets deflected due to static charge created on a charged pipe.

How does it affect the properties of water? Water has high melting point, high boiling point, high surface tension, expansion on freezing and most important, its ability of dissolving many polar compounds. These abilities make water a 'universal solvent'. That is why we find water of great use in all industrial applications. Water is used as, solvent in process industry besides universal cleaning agent in many industries.

Properties of water

Molecular structure of water

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Physical Properties: Water is unique in that it is the only natural substance that is found in all three physical states liquid, solid (ice), and gas (steam) at the temperatures normally found on earth. Earth's water is constantly interacting, changing and in movement. Water freezes at 0° C (32° F) and boils at 100° C (212° F). In fact, water's freezing and boiling points are the baselines with which temperature is measured: 0° on the celsius scale is water's freezing point, and 100° C is water's boiling point. Water is unusual in the solid form. Ice is less dense than the liquid form, which is why ice floats. Water has a high specific heat index. This means that it can absorb a lot of heat before it begins to get hot. This is why water is valuable to industries and in your car's radiator as a coolant. The high specific heat index of water also helps to reg-

ulate the rate at which air changes temperature. This is why the temperature change between seasons is gradual rather than sudden, especially near the oceans. Water has a very high surface tension. In other words, water is sticky and elastic, and tends to clump together in drops rather than spread out in a thin film. Surface tension is responsible for capillary action, which allows water (and its dissolved substances) to move through the roots of plants and through the tiny blood vessels in our bodies. Water temperature: Water temperature is not only important to swimmers and fishermen, but also to industries and even fish and algae. A lot of water is used for cooling purposes in power plants that generate electricity. They need cool water to start with and they generally release warmer water back to the environment. The temperature of the released water can affect downstream habitats. Temperature also can affect the ability of water to hold oxygen as well as the ability of organisms to resist certain pollutants. pH: pH is a measure of how acidic/basic water is. The range goes from 0—14, with seven being neutral. pH of less than seven indicates acidity, whereas a pH of greater than seven indicates a base. pH is really a measure of the relative amount of free hydrogen and hydroxyl ions in the water. Water that has more free hydrogen ions is acidic, whereas water that has more free hydroxyl ions is basic. Pollution can change water’s pH, which in turn can harm animals and plants living in the water. For instance, water coming out of an abandoned coal mine can have a pH of 2, which is very acidic and would drastically affect any fish crazy enough to try to live in it. By using the logarithmic scale, this mine-drainage water would be 100,000 times more acidic than neutral water so stay out of abandoned mines. Specific Conductance: Specific conductance is a measure of the ability of water to conduct electrical current. It is highly dependent on the amount of dissolved polar solids (such as salt) in the water. Pure water, such as distilled water, will have a very low specific conductance, and sea water will have a high specific conductance. Probably, in school you've done the experiment where you hook up a battery to a light bulb and run two wires from the battery into a beaker of water. When the wires are put into a beaker of distilled water, the light will not glow. But, the bulb does light up when the beaker contains salt water (saline). In the saline water, the salt has dissolved, releasing free electrons, and the water will conduct an electrical current. Turbidity: Turbidity is a measure of the cloudiness of water. It is measured by passing a beam of light through water and seeing how much light is reflected off the

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particles in the water. Water cloudiness is caused by material, such as dirt and residue from leaves that is suspended (floating) in the water. Crystal-clear water, such as Lake Tahoe and Lake Manasarovar) has a very low turbidity. Dissolved oxygen: Although water molecules contain an oxygen atom, this oxygen is not what is usable to aquatic organisms living in our natural waters. A small amount of oxygen, up to about 10 molecules of oxygen per million of water, is actually dissolved in water. This dissolved oxygen is breathed by fish and zooplankton and is needed by them to survive. Rapidly moving water, such as in a mountain stream or a large river dissolves a lot of oxygen, while stagnant water contains very little oxygen. The process where bacteria in water consume organic matter, such as that which comes from a sewagetreatment plant consumes oxygen. Thus, excess organic material in our lakes and rivers can cause an oxygen-deficient situation to occur. Aquatic life can have a hard time in stagnant water that has a lot of rotting, organic material in it, especially in summer, when dissolved-oxygen levels are at a seasonal low. Hardness: The amount of dissolved calcium and magnesium in water determines its 'hardness.' Water hardness varies throughout the sources. If you live in an area where the water is 'soft,' then you may never have even heard of water hardness. But, if you live in Florida, New Mexico, Arizona, or Solapur, where the water is relatively hard, you may notice that it is difficult to get a lather up when washing your hands or clothes. Industries in your area might have to spend money to soften their water, as hard water can damage equipment. Hard water can even shorten the life of fabrics and clothes. Does this mean that students who live in areas with hard water keep up with the latest fashions since their clothes wear out faster? Suspended sediment: Suspended sediment is the amount of soil moving along in a stream. It is highly dependent on the speed of the water flow, as fast-flowing water can pick up and suspend more soil than calm water. During storms, soil is washed from the stream banks into the stream. The amount that washes into a stream depends on the type of land in the river's drainage basin and the vegetation surrounding the river. If land is disturbed along a stream and protective measures are not taken, then excess sediment can harm the water quality of a stream. You've probably seen those short, plastic fences that builders put up on the edges of the property they are developing. These silt fences are supposed to trap sediment during a rainstorm and keep it from washing into a stream, as excess August 16-31, 2012

P|H|A|R|M|A| T|E|C|H|N|O|L|O|G|Y| R|E|V|I|E|W sediment can harm the creeks, rivers, lakes, and reservoirs. Sediment coming into a reservoir is always a concern; once it enters it cannot get out—most of it will settle to the bottom. Reservoirs can 'silt in' if too much sediment enters them. The volume of the reservoir is reduced, resulting in less area for boating, fishing, and recreation, as well as reducing the power-generation capability of the power plant in the dam. Aqueous Solution Geochemistry: Acid = substance containing hydrogen which gives free hydrogen (H+) when dissolved in water Base = substance containing the OH group that yields free (OH-) when dissolved in water. An acid solution is one containing an excess of free H+ , and a base is one containing excess of free OH-. A reaction between an acid and a base is usually called neutralisation. HCl (acid) + NaOH (base) ==> H 2 O + NaCl which are dissociated into ions: H + + Cl - + Na + + OH - ==> H 2 O + Na + + Cl - i.e. Na + and Cl - are unaffected. pH = inverse log of the concentration (activity) of free H+ , or pH = -log [H+] Water dissociates into H+ and OH- ; the dissociation constant is: Kwater = [H+] [OH-] =10 -14 So there has to be 10-7 moles each of H+ and OH- in a kilogram of neutral solution at standard temperature of 25°C. One mole is 6.023 x 1023 atoms (or molecules) and H2O has a molecular weight of 18 grams per mole. One kilogram of water has about 1000/18 = 55.6 moles of water or about 3.35 x1025 atoms of oxygen and about twice that number (6.7 x 1025 atoms) of H+ (the amount of free H+ or free OH- is relatively small compared to the amount of undissociated H2O). pH ranges at 25°C from 0 to 14; pH < 7 = acidic solution; pH > 7 = basic solution. If HCl or another acid is added then pH decreases; if NaOH or another base is added then pH increases. pH increases as carbonic acid (a weak acid) dissociates: When carbon dioxide combines with water, such as what happens in the atmosphere when fossil fuels are burned, carbonic acid is formed: H2O + CO2 ==> H2CO3 . Free H+ are made available during successive August 16-31, 2012

dissociations: H2CO 3 ==> H+ + HCO3- carbonic acid to bicarbonate, occurs at pH ~6.4 HCO3 ==> H+ + CO3-- bicarbonate to carbonate, occurs at pH ~10.3 Remember, free H+ is available only when acidic, or when pH < ~7. The dissociation of bicarbonate to carbonate occurs when there is too much OH- in the system and H+ is "released" to balance out the base.

Dissolved Cations and Anions in water Cations = electron donors, positively charged: Na+, K+ , Mg++ , Ca++ , Fe++ or Fe+++ , Mn++ , Al+++ Anions = electron acceptors, neg. charged: Cl- , F- , I- , Br- , SO4—, CO3—, HCO3- , NO3—, NO2Metals=act like cations mostly: Cu, Zn, Pb, Co, Ni, Cr, As, Se, Mo, etc. Water Analyses - Need to

have cation-anion balance Millequivalent (MEQ) = mole equivalent charge or anion or cation, measure of total charge due to the ion in question dissolved in the solution. Start with concentration, divide by mole wt., multiply by charge: XX mg/L / MW x CHG = MEQ Example: NaCl in solution, Na=50 mg/L (50 ppm): 50/23 x 1 = 2.17 MEQ Cl = 77 mg/L (77 ppm): 77/35.5 x -1 = -2.17 MEQ

So, if the total cation and anion MEQ’s are not balanced, some error exists in the analysis. The ability of water to dissolve polar materials, also finds its utility in Pharmaceutical industry as, 1. Solvent (To prepare Solutions) – To be considered as raw material 2. Cleaning Agent (The author can be contacted at kd.datar@tppl.net.in)

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Pharma Ally INTERVIEWS

‘Tectura and Microsoft have a symbiotic relationship’ Tectura’s Customer Relationship Management (CRM) solution for the life sciences industry is helping them to overcome some of the most common challenges they face with regards to maintaining relationships with their channel members and physicians. Chetan Pathak, Country Manager, Tectura India, reveals more in discussion with Sachin Jagdale Tell us about your partnership with Microsoft Tectura has global partnership with Microsoft. It offers business consulting services providing sustainable value through consulting, software, and, IT implementation. With its presence in more than 20 countries and 60 offices, Tectura is one of the largest Microsoft Dynamics partners having experience in over 5,000 engagements across industry verticals. Tectura has been recently awarded the Inner Circle Recognition at the Microsoft’s 2012 World Partner Conferenceth in Toronto. In fact, this is the 12 consecutive year that Tectura has been awarded Inner Circle recognition and this recognition truly highlights the relationship we have with Microsoft. Inner Circle is an elite group of the most strategic Microsoft Dynamics partners from across the globe with achievements that rank them in the highest echelon of the Microsoft Dynamics global network of partners. How are the responsibilities divided/ shared between Tectura and Microsoft in this partnership? Tectura and Microsoft have a symbiotic relationship. Microsoft is responsible for product development, product support, and product enhancement/upgrades. The intellectual property and all rights relat-

ed to the products belong to Microsoft. Microsoft is also responsible for creating and managing a partner eco system. Tectura is responsible for client acquisition. It provides consulting and product implementation services to the clients. Tectura is also responsible for post-implementation support to the clients. Do you need to upgrade/change CRM services depending on the market conditions that you are working in? The external environment for the life sciences industry is constantly changing. We help the life sciences industry to adapt and take advantage of the emerging opportunities by enhancing the product portfolio and personalising our services. There are now different deployment options – on-premise and cloud-based - available to the life sciences industry to optimally use the investment resources available for CRM. What are the major challenges facing the Indian life sciences industry? The Indian life sciences industry is increasingly facing intense competition and a volatile business environment. The industry is facing challenges in terms of maintaining growth rates and complying with ever increasing compliance require-

We have been getting favourable response from the Indian market in India for our new life science CRM solution. There has been a dearth of customer relation solutions specific to life science industry in the market and with the availability of life science CRM solution from Tectura, pharma companies are aiming to overcome some of the most common challenges they face with regards to maintaining relationships with their channel members and physicians 50

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ments. The costs related to sales and marketing are increasing as a percentage of revenue. The costs of new product introduction are increasing. The management of sales force is also becoming difficult due to increase in attrition rate. What is the feedback of your clients in India? We have been getting favourable response from the Indian market in India for our new life science CRM solution. There has been a dearth of customer relation solutions specific to life science industry in the market and with the availability of life science CRM solution from Tectura, pharma companies are aiming to overcome some of the most common challenges they face with regards to maintaining relationships with their channel members and physicians. Who are your clients in India and abroad? We have over more than 100 CRM customers across the globe. This shows that Tectura is easily the leading partner for Microsoft. We have experienced high growth rates in revenue from CRM solutions. We have customers across various segments of life sciences industry like generics, formulations and APIs. Our clientele include mid-sized companies and larger enterprises throughout the US, Europe, the Middle East, Africa, and Asia Pacific. Tell us about the cost effectiveness of Microsoft Dynamics CRM services. This particular solution is rich in features and is fully suitable for the life sciences industry. It caters to life sciences firms of all sizes – from a small size pharma company to a large enterprise. All these features come at a very market competitive price. Further, there are options to either go with an OnPremise solution or a cloud-based solution thus providing investment alternatives to clients.

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Besides life sciences, which are the other industries where this solution can be applied? This solution is suitable for various sub-segments of the life sciences industry. Besides life sciences, this solution can be applied to clinical trial companies. What percentage of your revenue comes from the life sciences industry? Some time back, we decided to focus on the life sciences industry. We have been strengthening our offerings and services for the life sciences industry since then. As a result of this, the life sciences industry accounts for a significant percentage of our revenue from new clients. What are your future plans for the next three years as far as Microsoft Dynamics CRM services are concerned? We will continue to acquire more customers and provide valueadding CRM solutions to them. We will provide inputs to Microsoft on product enhancements, based on our deep understanding of customer usage experience. We would like Tectura to be number one consulting partner for Dynamics CRM, with a best of breed solutions on Tectura Focus Verticals. sachin.jagdale@expressindia.com August 16-31, 2012

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‘Soon, we will have more than 100 engineers across India who can cater to the service’ Recently in Mumbai, Agilent Technologies launched its aftermarket solution under the brand name ‘Agilent CrossLab’. It provides solutions not only for its individual products but also for its competitors. In an interaction with Usha Sharma, Siva Kumar Pasupathi, Country Business Head – LSG & CAG Agilent Technologies, India reveals key features of the product Tell us more about Agilent Technologies’ newly introduced product and its features? Agilent Technologies is a global leader in the test and measurement segment. With Agilent CrossLab Services and Supplies, launched on July 20, 2012 in Mumbai, it raising the standards for technologies that support routine lab analysis. Agilent CrossLab Services and Supplies is a new innovative solution from Agilent Technologies for non-Agilent instruments. All our service contracts from Agilent Technologies are well documented contractual agreements. With CrossLab Agilent we will be able to provide comprehensive service contracts for all leading chromatography instruments from Shimadzu, Waters, Thermo, Bruker, Perkin Elmer etc. How prompt is this new technology in addressing client issues? Our latest solution helps users to keep their lab running at peak efficiency, regardless of the instrument manufacturer. From award-winning, multivendor qualification and compliance to expert service engineers and a broad portfolio of parts for both Agilent and instruments from other vendors, Agilent CrossLab has the key which is required to maximise lab uptime. The result is a lab-wide programme that is more personalised, more efficient, and more cost effective. In a nutshell, it is a single point of solution for non Agilent Services and Supplies. How did you come to develop this kind of service and how long did you take? Agilent Technologies has already been a leader in test and measurement segment. With an effort to strengthen our portfolio, we launched this aftermarket solution under the brand name ‘Agilent CrossLab’, which offers Agilent’s expertise, integrated solutions and services to the customers. With the help of aftermarket solutions, will you be able to address queries about your competitors designed machines. Tell us how you'll be moderating and why? Yes. We have trained and certified professionals who can give services to our competitor’s instruments. These professionals (Service Engineers) undergo a refresher training every 90 days. How many pharma and chemical companies have you are targetted? Why should these companies approach you rather than other manufacturers? CrossLab Services is already in the Indian market since the last three years. Earlier it was known as multi-vendor services. We have top 15 pharma companies accounting for more than 500-plus non Agilent instruments which is already in the contract. Customers have the benefit of a single point of solution, comprehensive contracts, which assure the least downtime of instruments, better budget planning as this is a comprehensive contract; cost advantage since it is a collective approach, and above all Agilent’s guarantee. What concessions would you like to provide for your services and what benefits will your clients get from the newly introduced technology? The first and foremost benefit of this solution is a single point of solution for non Agilent Services and Supplies as well. We have award-winning, multivendor qualification and compliance, qualified service engineers and a broad portfolio of parts for both Agilent and instruments from other vendors. Tell us how many people are working on this job? What active role they have undertaken to escalate this service to the next level. Presently, we have 40-plus trained and certified engineers across India. With CrossLab Services Lab coming up in Manesar we will soon have more August 16-31, 2012

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than 100 engineers across India who can cater to the service needs for non-Agilent instruments as well. It is the first after the facility in Engelwood, Colarado where engineers are trained on non Agilent instruments What marketing strategies have you planned and how aggressive are they? Recently, in the Mumbai we had an

VENDOR NEWS

official launch of CrossLab Service and Supplies at Hyatt Regency, Mumbai on July 20, 2012. It was attended by many leading pharma and biotech industry professionals. As a marketing strategy we are also running a health checkup campaign for non Agilent instruments across the country so that we can extend the reach of this service to tier II and tier III cities as well.

Tell us about your expectations from the aftermarket solutions and where do you see this product after two years? We have high expectations from this solution. This is a one of kind service in the Indian market. Agilent also provides this solution to other markets where we operate. u.sharma@expressindia.com

Waters, Nonlinear Dynamics to co-develop new analytical solutions To combine complimentary expertise in analytical science and informatics to advance proteomics and metabolomics research he $1.85 billion Waters Corporation and Nonlinear Dynamics have entered into an agreement to codevelop a new analytical solution that derives information from complex data sets generated by large-scale proteomics and metabolomics experiments. Waters and Nonlinear Dynamics collaborated on the development of the Waters Omics Research Platform with TransOmics Informatics first introduced in May during the ASMS Conference on Mass Spectrometry and Allied Topics in Vancouver combining both Waters SYNAPT G2-S HDMS and TransOmics Informatics developed by Nonlinear Dynamics’ under an exclusive worldwide OEM agreement. Founded in 1989 by Will Dracup, Nonlinear Dynamics developed the Progenesis data analysis software range which is innovative, ground-breaking and above all it helps to solve the challenges faced by proteomics and metabolomics researchers today. The fundamental analysis concepts developed by Nonlinear for the Progenesis software range help scientists visualise their complex data and generate reliable conclusions that are reproducible across labs. The approach has been applied to LC-MS and 2D gel electrophoresis data analysis. Nonlinear sells and supports its products through its UK headquarters and its US office, as well as a global network of partners. With the launch of Waters Omics Research Platform, Waters introduced two new solutions powered by Waters

TransOmics Informatics: Proteomics solution combining Waters nanoACQUITY UPLC and Waters SYNAPT G2-S HDMS mass spectrometer for the bottom-up analysis of complex mixtures. Metabolomics solution built around the Waters ACQUITY UPLC I-Class and Waters SYNAPT G2-S HDMS mass spectrometer for routine screening of large sample cohorts. Waters first introduced ion mobility to mass spectrometry with the introduction of the SYNAPT High Definition Mass Spectrometer (HDMS) in 2007. Used in small molecule research, protein characterisation, metabolite identification and bio-pharmaceutical applications, the Synapt HDMS system is still the only mass spectrometer to employ high efficiency ion-mobility based measurements and separations to enable the analysis of sample ions differentiated by size, shape and charge as well as mass. The added dimension of shape-selective separation increases the analytical specificity and sample definition so that scientists can extract more information from their samples, including the detection of components previously unseen by conventional mass spectrometers. “The complexity of biological samples is so great that the sensitivity and specificity of analytical techniques required for biological discovery presents scientists with significant challenges when it comes to managing experimental data,” said James Langridge, Director of

Pharmaceutical and Life Sciences Discovery, Waters Division. “We believe that through our partnership with Nonlinear Dynamics we can address this situation and advance the pace of discovery.” “I’m delighted to see this exciting partnership bring together the latest MS technology with world-renowned data analysis software,” said Will Dracup, Executive Chairman, Nonlinear Dynamics. “Researchers today are faced with large, complex data sets and they need to be able to visualise this and extract reliable results. The software Nonlinear has developed specifically addresses these issues, unlocking the potential of the valuable, content-rich, omics data that Waters’ ion mobility technology generates.” A common goal of any omics studies—whether proteomics or metabolomics—is to gain a clear understanding of the interplay between molecules at the protein and metabolite level leading to a better understanding of the underlying biology of an organism or a specific disease state. The Waters Omics Research Platform Solution facilitates research across multiple discovery areas for researchers in the pharmaceutical and life sciences, food, and clinical research areas. Waters intends to commence shipments of its UPLC/SYNAPT G2-S HDMS-based instrument solutions with TransOmics Informatics announced at ASMS during the fourth quarter of 2012. EP News Bureau

TTP Labtech Technology supports drug discovery research at University of Nottingham Academia steps up to the high throughput screening challenge with state-of-the-art compound storage facility TP Labtech, global developer and manufacturer of high quality, robust and innovative automated laboratory equipment, is enabling a successful new venture at the University of Nottingham’s Centre for Biomolecular Science, with its comPOUND sample storage system and comPILER high throughput, tube-to-plate processing system. The fully automated state-of-the-art facility for the Managed Chemical Compound Collection (MCCC) provides storage for more than 100,000 diverse drug-like small molecules for high throughput compound screening. The facility is key, not only to the university’s drug discovery research but also provides services to pharmaceutical and biotech industry partners, generating important growth potential for the University.

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The compound modular system provides a compact and secure, fully automated storage and dispensing facility for chemical and biological compound libraries. Up to 100,000 1.4 mL tubes or 200,000 0.5 mL microtubes can be stored per unit in a temperature controlled, dry, inert, hermetically sealed environment;

ensuring sample integrity. Sample storage in microtube format allows cherry picking of only the samples of interest and mitigates risks of sample degradation from unnecessary freeze/ thaw cycles, inherent with plate-based systems. EP News Bureau

National Pharma Machinery to be known as NPM Machinery ational Pharma Machinery will henceforth be known as NPM Machinery. At the same time, the manufacturing location and H/O has been shifted to newly built premises. The new manufacturing unit is located at Changodar an industrial hub near Ahmedabad. It has a state-of-the- art manufacturing facility spread over almost 20,000 square feet and a corporate administrative office block built on 10,000 square feet area. Construction of expanded manufacturing facility of almost around another 35,000 square feet area is following now. EP News Bureau

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MRC, NIHR to develop Phenome Centre in the UK Researchers at the Centre will investigate the phenome patterns of patients and volunteers by analysing samples

August 16-31, 2012

ry during the London 2012 Games. The laboratory in Harlow will see more tests carried out than at any other Games, with every medallist who steps on the podium and up to 50 per cent of all athletes being tested. Dr Rohit Khanna, Vice

President of Worldwide Marketing, Waters Corporation said, “Waters is proud to be part of this firstof-a-kind research centre and the opportunity to work with such distinguished partners in support of our mission: to develop technology that

allows science to provide answers to the critical challenges we face. This centre is a significant advancement for the science of phenome-typing, enabled by a powerful partnership of leading academic institutions, government and companies like

ours providing the latest innovations. We fully expect this centre will multiply our understanding of disease and help us to improve the health of populations around the world.” EP News Bureau

edical Research Council (MRC) and the Department of Health’s National Institute for Health Research (NIHR) will develop a Phenome Centre, which will use the cutting edge facilities developed for London 2012 to help develop better and more targeted treatment for patients. With an investment of five million pounds over a five-year period each from MRC and NIHR, the centre will be build with expertise from London 2012 Olympic's anti-doping facilities provided by GlaxoSmithKline (GSK) and operated by King’s College London. The MRC-NIHR Phenome Centre will enable the UK to make its world-class phenotyping technology and expertise available to both researchers and the life sciences industry to accelerate the translation of medical discoveries into better healthcare. The new centre will be led by a collaboration of academic partners, led by Imperial College London, and the suppliers of nuclear magnetic resonance and mass spectrometry equipment (Bruker and Waters Corporation). Researchers at the Centre will investigate the phenome patterns of patients and volunteers by analysing samples – usually blood or urine – very rapidly and on an unprecedented scale. This will help them to discover new ‘biomarkers’ to explain why one individual or population may be more susceptible to a disease than another. This knowledge will aid scientists in finding new, safer and more targeted treatments. Phenome analysis has already been used to ‘tailor’ cancer treatment to suit individual patients by, for example, minimising the toxicity and maximising the efficiency of drug treatments for colon cancer. GlaxoSmithKline (GSK) is the official laboratory services provider for the London 2012 Olympic and Paralympics Games. Through a groundbreaking partnership with King’s College London, GSK is providing the facilities and equipment to enable expert analysts from King’s to independently operate a World Anti-Doping Agency (WADA) accredited laborato-

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Innovations in ultra-low temperature freezer technology by Thermo Fisher Scientific High performance, ultra-low temperature (ULT) freezers are essential for the laboratory. Choosing the right freezer for lab applications is also necessary. Nagendra Kumar Maroor, Commercial Manager—Cold Storage, APAC, Thermo Fisher Scientific gives an outlay on it

oday, the freezer is as commonplace in the laboratory environment as it is in the home, and the need for precise refrigeration has grown considerably over the last few years. High performance, ultra-low temperature (ULT) freezers are an essential piece of equipment in the laboratory, providing long-term protection and storage for valuable biological samples on a daily basis in industrial, clinical and research applications worldwide. Therefore, protecting the integrity of samples is extremely important and can be achieved by combining rapid temperature recovery, temperature stability, and operational efficiency, all in a productive and comfortable lab environment. However, for lab applications, not just any freezer will do and choosing the wrong one can be costly. A freezer door that is opened frequently or kept open for extended periods of time could expose your samples to warm ambient air, creating an opportunity for decreased sample integrity. In addition, many lab professionals do not realise the consequences of storing valuable samples and materials, such as DNA, RNA, cells, and protein

ing thermal performance, safety and security through state-of-the-art engineering. These new freezers feature an outstanding BTU (British thermal unit) reserve. This leads to fast door opening recovery times so that sample integrity isn’t compromised. Based on the internal performance data, the freezers can save up to 15 per cent in energy usage when operated in energy-savings mode v/s high-performance mode. For GMP applications, high-performance mode offers ultra-tight temperature uniformity. Both options can be accessed through an easy-to-use, touch-screen interface. Using a combination of water blown foam insulation with vacuum panel technology, the new freezers maximise sample-to-vial footprint storage, energy and temperature uniformity. Five new

quently reduces freezer wall thickness from traditional foamed in place insulation. This new compact footprint means that storage and laboratory space is no longer taken up because of thick layers of insulation. Tight door seals also prevent warm, moist air from entering the freezer so ice builds up more slowly and less defrosting is needed. This design is also effective in preventing energy from re-entering the freezer, thereby improving energy efficiency and in-turn decreasing heat injection into

Energy-savings or high-performance mode through the touch-screen interface

Construction features include ergonomic door handle and polystyrene-insulated inner doors

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samples in conventional freezers. These units are not designed to maintain critical storage requirements demanded in most laboratory applications; inadequate systems result in wider temperature fluctuations, as well as uneven temperature distribution throughout the cabinet. Choosing a freezer that provides tight temperature uniformity and delivers rapid temperature recovery is vital in maintaining sample integrity.

capacities are available ranging from 300 cryobox capacity (30,000 2mL vials) up to 700 cryobox capacity (70,000 2mL vials). One problem with freezing is that it is an exothermic process, and the excess heat needs to be removed in some way in order to maintain controlled cooling. Advanced ULT freezers require, such as the new series of Thermo Scientific -86°C freezers, require less power to efficiently maintain cabinet temperatures which in turn reduces heat emissions into the lab environment. This reduces air conditioning and energy costs, and maximises operational efficiencies. In addition, a water-cooled condenser option is available for these new Thermo Scientific ULT freezers to further reduce energy usage. Another problem often faced in the lab is the noise levels associated with ULT freezers. Fortunately, the new Thermo Scientific ULT freezers have been constructed with an interior storage compartment that uses advanced noise abatement and super insulation technologies to help minimise noise output. These technological advancements mean that the ULT freezers are now a lot quieter, allowing them to reside directly inside the lab. Having the freezer inside the lab maximises efficiency in regards to sample preparation time and minimises sample exposure to ambient air. Researchers, who spend many hours surrounded by lab equipment, also benefit from a quieter and more productive, efficient, and comfortable working environment. Thermal insulation inside the freezers is achieved using super insulation, a vacuum formed panel consisting of multi-layers of glass fibre. This is encased by a non-gas permeable membrane to insulate the housing, which subse-

the surrounding environment.

Cold storage technologies ULT freezer technology is now a conventional industrial technology that has recently achieved a high level of maturity worldwide due to the increased levels of laboratory protocol regulations. Minimal fluctuations in temperature are critical to the viability and effectiveness of biomedical products so international regulatory bodies require laboratories to constantly monitor the temperature variation during the storage process. There is also a need for the cooling industry to develop costeffective and environmentally sustainable solutions to increase energy efficiency. This means focusing on technologies, materials, and solutions that enable new cooling solutions to be delivered in an environmentally responsible manner to enable standards for safety and performance to be met without compromising freezer performance.

New innovation in ult freezers There are ultra-low temperature freezers, and then there are the new series of Thermo Scientific ultra-low temperature freezers.Built specifically to protect the most critical of samples, the new Thermo Scientific -86°C freezers achieve outstand-

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Who is using this freezer? Our freezers have multiple security levels to fit your lab requirements. No access control required — use our fully accessible mode and this freezer operates like any other. Need to restrict who can change setpoints? — use our securemode where you can designate different types of users. General users can operate all aspects of the freezer but do not have access to change settings. Administrators can change freezer and alarm setpoints, as well as add and delete users.

Information at your fingertips A new touch-screen user interface provides access to vital freezer information, including event log, settings, user profiles and the ability to store up to 15 years of temperature and event data on its on-board computer.

Importance of wireless monitoring A mechanical or electrical failure can ruin your precious samples stored inside not just a freezer, but any lab product with a controlled environment. The Thermo Scientific Smart-Vue wireless monitoring solution safeguards the integrity of important laboratory storage by continuously monitoring critical parameters of laboratory equipment and securely logging data. Lab personnel are notified remotely when sample integrity is threatened. This wireless solution features audit trail traceability with conformance to 21 CFR part 11, and other regulatory requirements.

Conclusion There are several criteria to consider when evaluating the proper laboratory cold storage solution: Temperature stability and recovery; Sample integrity protection; Safety and security; Intelligent user interface ; Energy efficiency. Combining these advances with end user education ensures that, although it is not easy to be green in the laboratory it is at least possible now. (The author can be contacted at Nagendrakumar.maroor@thermofisher.com) August 16-31, 2012

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Express Pharma Business Avenues CUBE 2012 Pharma Conference 2012 An exciting, interesting and educating event for people from pharma industry and acedemia at your door step.

A great opportunity to meet and listen to renowned Speakers like B. R. Masal, FDA Joint Commisoner Pune Division Prem Gupta, Chairman, Belco Pharma, India Anil Bora, CEO, Centaur Pharma , Pune Ajit Singh, ACG Worlwide Rao Vadlamudi, Director at St. Peter's Institute of Pharmaceutical Sciences Abhay Harsulkar, Pharmaceutical Biotechnology and Scientist at IRSHA Onkar Nath Singh, Head, Corporate Quality, Aristo Pharma Ltd. Shambhaji Pisal, Director, R&D, Serum India Limited Dattatrey Ranjane, Vice President ( Operations) at Bharat Serums & Vaccines Ltd. Rajendra D. Patankar, Principal, Abhinav College of Pharmacy, Pune

4 September 2012 YASHADA, Baner Road, Pune, India

Limited Seats, Register now. Academia: INR 1,500 + TAX Company: INR 2,000 + TAX T: 0966 581 4269 E: info@thecubeconf.com Registration forms available on website http://thecubeconf.com/pharma-conference

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SPECIALTY CHEMICALS FOR RESEARCH, DEVELOPMENT AND PRODUCTION abcr supplies specialty chemicals to renowned pharmaceutical and chemical companies worldwide. Through our logistics centre in Karlsruhe, we organise and manage the distribution of products to more than 10,000 laboratories. The expertise and technical support provided by our chemists and engineers, together with short delivery times, have made us a “preferred supplier” for many customers.

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Sheffield BioScience is a leader in innovation and application for Cell Culture, Fermentation Diagnostic Media serving the pharmaceutical markets worldwide

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JOB TREND

July '12 hiring activity 15 per cent higher than previous year About 11 per cent recruiters also stated that there will be no hiring in the coming months harma sectorsâ&#x20AC;&#x2122; hiring activity in July2012 is 15 per cent better than what it was a year ago but two per cent lower than what it was

last month. It is interesting to note that there has been stability in hiring for quite some months and not much action has been witnessed. A survey

The Naukri Job Speak Index for the pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas

with recruiters on the hiring outlook for the coming months also does not forecast a healthy picture with only 51 per cent recruiters stating that new jobs will be created in the second half of 2012. About 11 per cent recruiters also stated that there will be no hiring in the coming months. Methodology: The Naukri Job Speak index is on the basis of job listings added to the site every month. To calculate the index, job listings added to the site in July 2008 have been taken as 1,000. The subsequent months have been indexed with data of July 2008. The monthly report shows hiring trends across industry sectors, geography and functional areas. There might be high volatility for certain fringe cases like smaller cities, niche industries etc. owing to a small base, but more than 42,000 clients using Naukri.com leads to high reliability of the data.

Jobs from Naukri.com Assistant Manager Company: Profile: Exp: Location: Email:

Senior Executive- IT

Hetero Drugs Must have MBA or commerce degree with six to eight years experience in project management, in-licensing,agreement drafting,vendor management. 6-8 Hyderabad / Secunderabad manasa.u@heterodrugs.com

Company: Profile: Exp: Location: Email:

Concept Pharmaceuticals Graduate in IT with 2-3 years of working experience in ERP enviornment. 2-3 Mumbai jobs@conceptpharma.com

Manager - Quality Assuarance Quality Assurance- Executive Company: Profile: Exp: Location: Email:

Marion Biotech Must be able to carry out validation studies for equipments, system and procedures. 1-2 Noida hrd@marionbiotech.com

Company: Profile: Exp: Location: Email:

Alkem Laboratories Responsible to lead Q A Dept. of the unit and must have experience in IPQA, Validation & GMP Compliances. 8-12 Gangtok hrd@alkem.com

Senior Manager - Finance Senior Chemist Company: Profile: Exp: Location: Email:

Actis Generics M.Sc/Ph.D with Organic chemistry having experience in reputed pharmaceutical industries. 0-5 Visakhapatnam bskreddy@actispharma.com

Company: Profile: Exp: Location: Email:

JB Chemicals Pharmaceuticals Responsible to set up systems to ensure that Financial Internal System & Controls are in place & guide the team to release MIS and other relevant data within targeted time frame. 7-10 Mumbai corporatehr@jbcpl.com

Software Engineer Imaging Company: Profile: Exp: Location: Email:

August 16-31, 2012

BioGenex Life Sciences Must be expert in designing and developing algorithms to drive high throughput digital imaging and analysis. 2-5 Hyderabad / Secunderabad krishna.j@biogenex.com

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P|H|A|R|M|A| L|I|F|E REPORT

Compensation on the rise for healthcare regulatory professionals: RAPS Regulatory professionals play many critical roles in bringing medical innovations to market. They are uniquely positioned to understand and negotiate the confluence of medical science, regulation and business. A report compiled by RAPS highlights the current state of the regulatory profession and helps bring greater transparency to who regulatory professionals are, what they do and how they are compensated. Excerpts from the report he Washington, DC-based Regulatory Affairs Professionals Society (RAPS) recently released the results of its 2012 Scope of Practice & Compensation Report for the Regulatory Profession. The report states that regulatory professionals are highly valued by companies in the life sciences and healthcare products sector. Regulatory professionals perform varied, vital work and are being rewarded with increased compensation. The report is based on survey responses from 2,750 regulatory professionals in 58 countries, including India. Sherry Keramidas, Executive Director, RAPS said, â&#x20AC;&#x153;While many life sciences companies have downsized, the results of this study show that regulatory professionals are more indispensable than ever. They play key roles in all aspects of bringing medical innovations to market, and uniquely combine strong expertise in medical science, regulation, business and strategy. The fact that compensation continues to rise shows employers recognise their value.â&#x20AC;? Regulatory professionalsâ&#x20AC;&#x2122; base salary and total compensation grew in the US, Canada and some European countries despite a tough global economy and workforce cutbacks in areas such as pharma. In North America, base salaries increased by two per

cent, and total compensation grew by an average of 17 per cent. Over the past decade, total compensation grew by 29 per cent. Regulatory experience is a key factor in compensation, according to the data, but the overwhelming majority (96 per cent) of regulatory professionals began their careers in another, related field, such as research and development (28 per cent), quality (21 per cent) or laboratory sciences (eight per cent). On average, they have eight years of prior professional experience before moving into regulatory. 90 per cent hold a university degree in the sciences, a clinical discipline or engineering. Another important factor in compensation is holding the Regulatory Affairs Certification (RAC) credential, the only accredited, post-academic, professional credential for regulatory. RAC holders in the US, on average, earn 10 per cent more than their counterparts without the credential. RAPS has created a salary calculator based on survey data, available online at www.RAPS.org/salary, which allows individuals to input factors such as RAC status, education and experience to get an average salary for regulatory professionals with similar backgrounds. The work of regulatory professionals has evolved over the past decades

and has shifted from an emphasis on compliance to a more varied scope of practice that includes involvement in the full product lifecycle from product development through submission, manufacturing and postapproval, including business and regulatory strategy. The work of regulatory professionals continues to be global and includes multiple product types, including pharma, medical devices, biotechnology products and others. RAPS is the largest global organisation of and for those involved with the regulation of healthcare and related products, including medical devices, pharma, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organisation. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognise regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide.

Regulatory professionals work at jobs ranging from entry level to corporate executives, across a variety of work settings focused on the development and use of health and wellness products. The job level and employment setting characteristics of professionals in the 2012 study have not changed significantly from those reported in 2010 and earlier studies

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August 16-31, 2012

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2010-12, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. AT IND.EXP.PSO.

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