I N D I A’ S F O R E M O S T P H A R M A & B I OT E C H P U B L I C AT I O N February 16-28, 2013 ` 40
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Pharma VOL 8. NO. 8 FEBRUARY 16-28, 2013
Chairman of the Board Viveck Goenka
CONTENTS MANAGEMENT
Editor Viveka Roychowdhury*
Compulsory licensing: The wild card?
BUREAUS
PAGE 28
Great expectations from
Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das
Budget 2013-14
PAGE 31
To poll or not to poll
Bangalore Neelam M Kachhap
PAGE 36
RESEARCH
Delhi Shalini Gupta
Quantum dots as nanoshells
PAGE 38
MARKETING Deputy General Manager Harit Mohanty
PHARMA ALLY
Senior Manager Rajesh Bhatkal
Quality in APIs
PAGE 63
Waters introduces peptide separations
PRODUCTION
chromatography columns
General Manager B R Tipnis
PAGE 65
Shree Gaurav launches silicone
Production Manager Bhadresh Valia
transparent tubing
Asst. Manager - Scheduling & Coordination Arvind Mane
PAGE 67
PTR (IT@PHARMA)
Asst. Art Director Surajit Patro
Wanbury gives managers access... PAGE 69
Chief Designer Pravin Temble
P-LIFE
Senior Graphic Designer Rushikesh Konka
Ranbaxy honours outstanding scientists... PAGE 72
Photo Editor Sandeep Patil Layout Rakesh Sharma
lopment
C I R C U L AT I O N Circulation Team Mohan Varadkar
R
Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.
February 16-28, 2013
MARKET
cartons pharma flexibles plastic films corrugation packaging development testing services
enquiry@ansapack.com
‘We are in talks with leading pharma companies to introduce Elores in South Africa and later in US’ PAGE 16 Pharmexcil invites comments from industry on EU directive notification
PAGE 18
M&A activity in pharma sector focuses on expanding product offerings
PAGE 22
STEM-2013 redefines stem cell research in India GIPC-2013 sees congregation of IP experts
PAGE 24
PAGE 25
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EDITOR’S NOTE
Human rights vs principles of science The new rules on compensation for death/injury during clinical trials once again highlight the tough choices faced by our policy makers: how do they uphold human rights while safeguarding the principles of science governing clinical trials? The process of framing compensation guidelines for volunteers on clinical trials conducted in India took a little more than a year. It started out with a draft published in November 2011, followed by meetings with stakeholders to get their views and by January 30 this year a Gazette notification announced the contours of Rule 122-DAB to be added to the Drugs & Cosmetics Rules 1945, as the First Amendment (2013). But, was the consensus building just a smoke screen? Industry was in for a bit of a rude shock by the final notification published on January 30. (See report: http://bit.ly/1215poK). The amendment gives the Drug Controller General (India) the final say on which cases merit compensation as well as the amount, under advice from expert committees. Global CROs conducting trials in India have in fact paid compensation for trial-related deaths in other jurisdictions so this would seem to be a business risk they live with. What they object to is the fact that the new rules do not seem to have any safeguards or are silent on crucial details. For instance, there is no clarity on the composition of the expert committees, so how can bias not be ruled out? There is no appeals process as well so the DCGI’s decision to stop a trial cannot be appealed. Industry bodies like ISCR point out that not differentiating between trial-related and trial non related injuries when deciding compensation could in fact be seen as an inducement. Similarly, ISCR feels that a sponsor should not be held responsible for injury or death arising out of misconduct or negligence by an investigator as this eventuality should be covered by the laws of medical negligence. ISCR also contends that the new rules contradict the definition of a clinical trial when they call for compensation for injury or death due to the failure of the investigational product to provide ‘intended
8 EXPRESS PHARMA
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therapeutic effect’, because this is just what the trial is trying to observe. Similarly, the use of a placebo in placebo-controlled trials is central to the scientific base of a clinical trial and hence compensation cannot be given to a patient/volunteer who may have got the placebo. Sources see the hand of ministries other than the Ministry of Health & Family Welfare, in some of the deviations between the final draft approved by all stakeholders and the one finally published on the CDSCO’s website on January 30. For instance, given the medico-legal aspects of deaths during clinical trials, sources surmise that the law ministry would have definitely weighed in to crack down on what is seen as the industry’s attempt to pass off responsibility. And since the Gazette Notification comes into force from the date of release, there can be no changes unless it is legally challenged, which is sure to be a long painful process. There is no doubt that patients/volunteers need to have a legal safety net, particularly in a country like India, where low levels of rural literacy and economic factors have created a class of professional patients for whom clinical trials are a livelihood. At the other end of the spectrum, we have patients who do not even realise they were enrolled in trials. In the clash of human rights and the principles of science, (as well as business interests and political posturing) are we in danger of missing the wood for the trees? Yes, we need to protect the rights and safety of patients and volunteers on clinical trials but if the rules are so stringent that industry decides to take clinical trials elsewhere, India runs the risk of not having access to new generation drugs tested on our populations. Policy makers will have to ensure that while they focus on getting it right today, they do not lose sight of their responsibility to future generations of patients in the country. Viveka Roychowdhury viveka.r@expressindia.com
February 16-28, 2013
MARKET
W H AT ’ S INSIDE
THE BUSINESS OF PHARMACEUTICALS
‘We are in talks with leading pharma companies to introduce Elores in South Africa and later in US’ PG 16 Pharmexcil invites comments from industry on EU directive notification PG 18 M&A activity in pharma sector focuses on expanding product offerings PG 22 STEM-2013 redefines stem cell research in India PG 24 GIPC-2013 sees congregation of IP experts PG 25 Bangalore India Bio 2013 ends on a promising note PG 26 High Potent Drugs-2013 debates regulatory complexities PG 27
MANAGEMENT 28 RESEARCH 36 PHARMA ALLY 63 PHARMA LIFE 72 February 16-28, 2013
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According to IMS Health study report, in 2011 Spain became the fourth largest pharmaceutical market in Europe with a market size of $22.7 billion. The Spanish market registered a Compound Annual Growth Rate (CAGR) of ~4.4 per cent during CY2007-CY2011. The revenue of the Spanish generic pharma market stood at $2.20 billion in 2010, which is expected to reach $7.19 billion in 2017, at a CAGR of 18.4 per cent from 2010 to 2017. The market is dominated by branded medicines with a share of about 88 per cent value wise. The highly regulated markets like the US, Germany, France and the UK have emerged as the leading suppliers of medicines to Spain. Of these four countries, three belong to the European Union and with strict manufacturing guidelines in their own countries; they are able to get easy access to the Spanish market. About 200 member companies of European Federation of Pharmaceutical Industries and Associations (EFPIA) operate in Spain. Presently, in Spain there are 1953 pharma companies including the subsidiaries, which are registered with the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) for supply of medicinal products. Also, the manufacturing sites in Spain have received approvals from US Food and Drug Administration (US FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency, Japan (PMDA).
Branded and generic market As per information shared by research analysts from Cognizant Technology Solutions, according to the European Generic Medicines Association (EGA), generic medicines in Europe have generated savings of Euro 30.00 billion. In terms of value, Germany is the largest market with a share of 27 per cent in the European generic
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pharma market, closely followed by the UK with a market share of 25 per cent with growth rates of six per cent each. On the other hand, though Spain and Italy account for smaller market shares of 4.2 per cent and 2.7 per cent, these markets present remarkable growth rates of 18 per cent and 22 per cent respectively. Germany and the UK are the two most developed generic markets constituting shares of 64 per cent and 60 per cent respectively in terms of volume penetration and accounting for more than half of the total generic pharma market in Europe. However, less mature generic pharma markets such as Spain and Italy present market shares of 29 per cent and 28 per cent respectively with regards to volume penetration. Revati Kasture, Head CARE Research says, “The government is focused to increase the uptake of generic drugs in order to reduce the healthcare burden. The share of generic drugs increased by 40.3 per cent year-on— year value wise and 36.5 per cent year-onyear volume wise during 2011 on the back of the significant regulatory changes implemented in the last couple of years. The revenue of the Europe generics pharma market was $36.44 billion in 2010. The market is expected to reach $62.71 billion in 2017, at a CAGR of 8.1 per cent from 2010 to 2017.” According to Maria Aurora Paul, Analyst from Cognizant Technology Solutions, “In Spain, following the acquisition of Ratiopharm, Israel-based pharma company Teva Pharma became the leading generic pharma company in terms of sales and the second largest generic pharma company in terms of units with a portfolio of 204 products, selling in approximately 558 dosage forms and 820 packaging sizes. Indian and Chinese-based pharma industry; with their capacity to produce API’s at a very low cost are also driving down prices and maximising their market share at the expense www.expresspharmaonline.com
REVATI KASTURE
MARIA AURORA PAUL
Head, CARE Research
Analyst, Cognizant Technology Solutions
The government is focused to increase the uptake of generic drugs in order to reduce the healthcare burden
Indian and Chinesebased pharma industry; with their capacity to produce API’s at a very low cost are also driving down prices and maximising their market share at the expense of European manufacturers
of European manufacturers.”
Oncology and Lupin Europe. During 2011. India exported pharma drugs worth ` 610.93 crore ($135 million) to Spain, which is mere ~1.3 per cent of India’s total drugs and pharma exports during the year. However, the exports to Spain have grown at a CAGR of seven per cent during FY2007-FY2011. Shivaji Sykam, Senior Analsyt from Cognizant Technology Solutions highlights, “Spain is one of the member states of the EU and regulatory environment is almost alike in all the member states. It is seen that the Indian healthcare providers have limited understanding about the healthcare sector in most EU countries except UK's NHS. Since each EU country has its own complex and evolved healthcare system, according to the respondents, this lack of awareness within the Indian healthcare provider community automatically constrains the scope for providing healthcare services to the EU market at large.” The second factor that emerged as critical for shaping bilateral relations in healthcare was linguistic,
Indian companies In Spain, the generic pharma market is largely represented by local companies. Regulations in the 17 local regions have varying policies regarding generic substitution. However Paul says, “Following the reduction of gross generic prices and lower maximum discounts, we expect generic penetration to increase. Spanish pharma revenue is $22679 and in 2011 the Indian pharma exports to Spain were ` 610 crore. Today, most of the generics sold in Spain are produced in the country by Spanish companies itself; only 37 per cent are imported from outside. Presently, Indian pharma companies operating their business in Spain through organic and inorganic procedures are Ranbaxy, Combix (Zydus Cadila), Sun Pharma, Genericos Juventus, Dr Reddy’s [Dr Reddys Laboratories (UK)], Hetero Europe, Jubilant Pharmaceuticals (Jubilant Life Sciences), Laboratorios Aurobindo, Nicholas Piramal India, Orchid Europe, Dabur
February 16-28, 2013
M|A|R|K|E|T social, and cultural affinity. Lack of such affinity between India and most EU countries was seen as a major constraint to India's delivery of healthcare and related services to the EU market. It is also seen that healthcare is a highly personalised service where perceptions, attitudes, and social and linguistic ties play an important role. Thus, India's prospects were perceived to be limited to the UK market and a few EU countries that have English-speaking capabilities. The adjacent table (units are in crores) shows that the trading of generic drugs from India to Spain gradually increased from 2007-2011 and would continue to do so as the Spanish government is promoting the usage of generic drugs.
India and EU trade relation A variety of constraints are faced by Indian healthcare providers in providing health services to the EU market. These pertained to regulation in EU Member States or at the EU-wide level, which include, restric-
February 16-28, 2013
Source: Cognizant Technology Solutions tions on outsourcing certain kinds of health services to providers outside the EU territory; data protection and data exclusivity laws; accreditation and certification requirements for healthcare
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establishments and compliance issues with international or EU standards and guidelines; insurance portability restrictions and coverage issues; recognition of professional qualifications and reg-
istration requirements; immigration and visa regulations affecting mobility of providers; and national treatment restrictions and discriminatory treatment which put Indian healthcare
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M|A|R|K|E|T providers on an uneven playing field with EU-based providers and undermined their market access vis-à-vis competitor countries in the EU. Such issues are likely to feature importantly in any efforts to develop bilateral relations with the EU in healthcare. Sykam emphasises, “The trade negotiations between the EU and the Indian government have been going on for many years. Inspite of the various constraints there has always been a gradual increase in the pharma exports from India and is also expected to continue in 2013.” The generic penetration is currently low in Spain as compared to the other European countries. As per Farmaindustria Annual Report 2011 and IMS Health, the breakup of branded and generic medicines in Spain is 87.4 per cent and 12.6 per cent respectively by value and 72.3 per cent and 27.3 per cent by volume respectively. Kasture shares, “The Government of Spain has concentrated its efforts to make significant public spending cuts in order to achieve the 2012 budget deficit target of 5.3 per cent of GDP, bringing it down from 8.9 per cent of the GDP in 2011. During the last couple of years, significant regulatory changes have
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been made by the Government with a focus to reduce the public spending in pharma, which has adversely impacted the revenue and profitability of the pharma industry in the country.”
Stringent regulatory environment The Government of Spain has made significant efforts and regulatory changes to reduce healthcare cost and this would entail increasing use of generic medicines. This would augur well for the Indian pharma companies in the long run. However, it offers a lower margin opportunity for them due to prevalent pricing and reimbursement control in the country. The Madrid Government has approved a controversial Royal Decree 16/2012 - law in April 2012 to guarantee the ‘sustainability of the National Health Service’, aimed at saving Euro 3.6 billion in the coming years. The funding of the healthcare system will shift from one that provides coverage to all through general taxation to a system funded by social security contributions, shares Cognizant Technology Solutions report. This law incorporates and expands the latest cost-cutting measures: pricing review, de-listing, promotion of generics usage through prescribing cheapest generic version of a drug, out-of-pocket payments for patients, limits to immigrants using the national healthcare system, and centralised purchasing of flu vaccines. Introduction of mandatory prescription by active ingredient in 2011 obliges pharmacists to offer the cheapest drug to promote generic dispensing, but unbranded medicines have also suffered harsh price cuts. IMS Health estimates that in the last three months, generics have more than doubled their market share to almost 68 per cent, although volume and revenue data may tell a different story. Also in July 1, 2012, 426 drugs were officially withdrawn from the government's basic cowww.expresspharmaonline.com
payment list. Decree Law in 2012 allowed for prescription by brand names of the drugs and also prevented their replacement by any other cheaper drug. But if the prescription is by active ingredient, then a generic drug at the same price is preferred over the branded drug. It also provided for de-listing of more than 400 medicines that are meant for minor syndromes such as heartburn, diarrhoea, constipation, cough etc. It introduced a new variable copayment system on the basis of users’ annual income. So far, the new Spanish Government and its Ministry of Health, with new health minister Ana Mato, is not expected to radically change any of the austerity measures and decrees in the short term, while some changes might occur in the mediumto-long term due to pressure from the national and regional pharma associations to overturn the situation and avoid a system. In the meantime, the new government looks at supporting the pharma industry which has mostly been affected by the costcutting decrees and pharma payments delays, and commits to pharma repayments in the short-to-medium term. Also, the reference pricing system (RPS) was further reformed by Royal Decree Law (RDL) in 2012. The resolution, for the first time, regulated reference prices for hospital medicines. The system keeps as the reference price the lowest cost/treatment/day of the medicines that make up the group of medicines. The same active ingredient and route of administration must include, as part of the National Health System’s pharmaceutical assistance, at least one generic medicine or biosimilar medicine. Kasture reveals, “The new wording of Article 93 leaves out of the regulation of substitution, applicable to the homogeneous groupings by virtue of the conditions laid down in the new wording of Article 85. For this reason, all medicines eligible for one of the sets, regardless of whether or not they can be substituted mutually, are now affected by the RPS.”
Impact of pricing and reimbursement According to the Ministry of Health, growth in the number of prescriptions volume increased by just 1.62 per cent in 2011, in comparison to 2.54 per cent growth
SHIVAJI SYKAM Senior Analyst, Cognizant Technology Solutions
Spain has been delaying payment to the pharma industry for a number of years, and now its regional governments owe the industry tens of millions of euro in 2010 and 4.94 per cent growth in 2009. Generic penetration across the key European markets is represented in the following graph, Spain ranks fifth but cost-containment issues are due to euro crisis – affecting almost all European countries. The other regulated key European markets to venture are Netherlands, France and Italy. The UK and Germany are highly penetrated by Indian pharma companies and are in the top five of 20 leading generic drug revenue generating countries. Sykam reveals, “Spain has been delaying payment to the pharma industry for a number of years, and now its regional governments owe the industry tens of millions of euro. Analysts at Business Monitor International say that pharma sales to pharmacies and hospitals declined 2.2 per cent in France, 3.1 per cent in Italy and nearly nine per cent in Spain. IHS Global Insight reports that Spain has cut its spending on medicines by a record 8.8 per cent, thanks to its austerity package and three cost-cutting royal decrees. Spain spent Euro 11.1 billion ($14.4 billion) on medicines in 2011, which resulted saving of Euro 1.4 billion on the previous year. This continues a decline in pharma spending in the country that began in 2010 when pharma expenditure fell by 2.3 per cent.” February 16-28, 2013
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Costs and pricing In most cases, the manufacturing costs for generic medicines are the same as for the original product. The only parameter for reducing costs is the price of the active pharmaceutical ingredient (API). Price linkage requires the generic medicines to be set at a fixed percentage discount to the originator which can seriously disadvantage its introduction and financial viability. This is especially the case when the originator company adjusts prices downwards, prior to generic entry. In Spain the legislation only allows reimbursement prices to go down. This causes a problem for generics manufacturers when they have increasing costs such as salaries and energy bills yearon-year. By adopting the lowest price approach, sustaining the current supply of generic medicines in all countries could be a problem.
A report by IMS Health’s Farmaindustria’s, released figures showing that drug sales in Spain have dropped by 11 per cent in 2012. But the generic industry in Spain have enjoyed some growth in the face of the branded pharma squeeze. Its market value has increased from five per cent in 2008 to 17.4 per cent in the year 2012.
5.105. Generally, European markets, such as the UK, Germany and Netherlands are characterised by relatively high generic penetration (~50 per cent+), other key markets like France, Italy and Spain has low generic usage at around 25 per cent. Apart from generic penetration, the reimbursement policies and consequently pricing also differ across markets.
u.sharma@expressindia.com
Increasingly stringent regulations The generics industry also faces an increasing burden due to pharmacovigilance, periodic safety update reports (PSURs) and the necessity for Braille packaging. Rising costs in quality assurance, anti-counterfeit measures and product security are also adding costs, and must all be absorbed without the ability to counteract them with price adjustments. Farmaindustria, the pharma industry trade body reported that the sustainability of the National Healthcare System is at stake and the image of the Spanish industry abroad is being impacted”. For multinationals, there is the sense that the environment is hostile for business and unpaid debts are becoming unsustainable, leading Roche to impose credit limits on supplying oncology drugs earlier this year. Big players may well decide to divert operations to emerging markets or countries that are not affected by the Euro crisis.
Growth projection In Spain, the generic medicines market during the 12 months ending (July 2010 June 2011), only represented 10 per cent of the total pharma market in value and 23 per cent in volume. Today, the generic medicines market in Spain integrates 187 active substances. The number of EFG’s approved by the Spanish Agency of Medicines and Sanitary Products is of February 16-28, 2013
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‘We are in talks with leading pharma companies to introduce Elores in South Africa and later in US’ After spending a decade over research, Venus has recently launched its novel antibiotic adjuvant entity to combat antimicrobial resistance caused by MDR, ESBL producing strains in India. It also has plans to take this product to the next level within the coming years. Dr Manu Chaudhary, Joint Managing Director and Director—Research, Venus Remedies shares the company's marketing and branding strategies for Elores with Usha Sharma Recently, Venus launched Elores, an antibiotic adjuvant entity (AAE). Tell us more about it? It took Venus almost 10 years of constant hard work, focused approach and dedication to develop this breakthrough product named 'Elores' and bring it to the world. It is a novel antibiotic adjuvant entity (AAE) to combat antimicrobial resistance caused by MDR, ESBL producing strains. It is designed specifically to target growing bacterial resistance mechanisms. Elores has a unique profile of action which gives it an edge over all the existing therapies. This unique antibiotic adjuvant entity creates a synergistic effect due to its activity on acquired multiple resistance in Gram Negative Enterococci and Rods which acts by multiple mechanisms. The product is effective against Metallo betalactamases (MBL) producing pathogens which are not susceptible to most of the existing antibiotics. It is also unique in its way that it not only kills resistant pathogens (bacteria) but also prevents the spread of resistance. What marketing strategies have you adopted for Elores and how you are going to implement them? We have a dedicated team of highly specialised and trained people for promotion of this product. We have plans to launch this product pan-India and in the first phase we have launched the product in Delhi NCR for the northern region. Similarly, we will be launching it in the other three territories of the nation i.e. East, West and South. We have set up a special department and a team for its promotion and market-
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beneficial for the patients.
INTERVIEW
ing, who has already started working dedicatedly for Elores only. How much revenue are you targeting from this new launch? How do you plan to achieve the set targets? We have our marketing strategies in place and we are working in line with it to achieve our set goals for Elores. We are expecting to gain 10 per cent of the share of the AMR segment Elores caters to in the next five years, making it an over ` 2.0 billion product. Apart from the domestic marketing plans, we are also in talks with leading pharma companies to introduce Elores in South Africa and later in the US as well. We have already secured patents for Elores from all over the world, including countries like US, EU (37 European countries), Australia, and Russia. The company is awaiting registration grants for Elores from European regulatory bodies to commercialise it there sooner. Our next international launch would be in South Korea where clinical trials on this product are expected to be completed later this year. Why do you think Elores is the need of the hour? Elores is the need of the www.expresspharmaonline.com
hour because it is clinically proven to be the best product so far against MDR, ESBL and MBL producing strains. As per the rising AMR scenario, the currently available ICU drugs are developing resistance very fast and there are regions in India where this resistance is as high as >90 per cent, thus Elores is the only hope for the medical fraternity in such a scenario. We have conducted clinical trials phase I, II and III successfully on a large patient population of 654 patients to prove clinical efficacy and safety in ESBL/MBL resistant pathogens. According to a study conducted in Delhi, patients with hospital-acquired infections (HAI) experienced a significantly longer hospital stay (mean: 22.9 days); significantly longer intensive care unit (ICU) stay (mean: 11.3 days); a significantly higher mortality (mean: 54 per cent) and cost significantly more (mean: $14, 818) than the patients resistant to hospital acquired infections. So, Elores is the need of the hour as it would be able to curtail these statistics. It would be able to reduce a minimum of 30 per cent of the hospitalisation costs and a minimum of 50 per cent of the drug cost, thereby proving to be very
What is the speciality of your newly launched product? Our product Elores is a novel AAE which is patented from 45 countries of the world due to its unique synergistic feature to fight with multi drug resistant ESBL/MBL producing bacteria including superbugs like NDM-1. Elores increases cell permeability, down regulates 'Efflux pump over expression', breaks bacterial 'Biofilms', prevents 'Transfer of resistant plasmid' and hence the spread of resistance is controlled. How much has been spent on Elores and how much time did it take to launch the product in the Indian market? On an average, we have spent 10 per cent of our company's revenue in research and have been investing almost 20 per cent of the company's R&D expenditure for developing and establishing this technology itself. Which are the other markets you are eyeing and why? We are eyeing all the major regulated markets starting from South Korea, Europe, South Africa, the US and all other markets where we have patent protection till 2025. Why are you considering these countries as prospective markets for the product and how soon will it be launched in these markets? We have patent protection in 44 countries, thereby we have exclusive rights in these territories till 2025. Hence, we have hired the services of one of the top four leading pharma consultancy providers to help us in finding suitable partners to introduce our product 'Elores' in various overseas markets by out-licensing this to multinational companies who have big marketing muscles in the specified territories. We are planning to launch Elores in South Korea by next year. Besides this, we are awaiting regulatory approvals from European bodies to commercialise the product in the February 16-28, 2013
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European markets very soon. Tell us how many medical representatives have been employed by Venus and how many of them have been deputed for only Elores? We have a full fledged team of 700 marketing professionals all over India. For Elores, a department has been set-up with highly professional medical representatives who will be dedicatedly working on the promotion and marketing of Elores across top 100 hospitals of India.
quality and innovations. We are progressing in this direction by working hard to fulfil these missions and to create an IP wealth of $1 billion by 2015. How much will be spend on R&D and marketing in the coming fiscal? On an average, Venus is spending 10 per cent of its
revenue in the research. For marketing, we already have a marketing force of 700 professionals and we have already initiated the process of recruiting more for the coming fiscal. What was the turnover of the company in the last year and how much will it be in the current fiscal?
In the last year 2011-12, the turnover of the company was ` 405 crore. This year in 2012-13, it is expected to grow at around 15 per cent. How large is your international business presence and how much does it contribute to the total turnover? Currently, we have presence in six continents and 60
countries around the globe. We have 11 international marketing offices including US and Germany, among the most demanding pharma destinations in the world. Around 30 per cent of the company's turnover comes from exports with 10 per cent from Europe and 20 per cent from the rest of the world. u.sharma@expressindia.com
Do you plan to increase the manpower strength of medical representatives in the near future? Yes, we are already in the process of hiring. We are also building Venusian's Chamber, a global marketing office for Venus on NH 22. It would be a business incubator providing global market space and would be dealing in developing and implementing ongoing marketing plans for the successful promotion of products, achieving effective sales and marketing results. Presently, how many products are in the pipeline and how soon will they be launched in the Indian market? At present, we have eight products in the pipeline which are at different phases of development. Apart from these, four products are in the 'soon to be launched' category, which would be launched in the next two to three years, depending upon various regulatory approvals. For the coming financial year, do you plan to expand your business? We already have our hands full with a kitty of 70 products, including 13 research products which are doing very well in various markets around the globe. We are into complex molecules' manufacturing like carbapenems and oncology. At present, our main focus is to strengthening our product portfolio with more novel research products. By 2018, where do you want to position your company? Our mission is to establish Venus Remedies as an innovator company and to be a globally admired pharma company for world class February 16-28, 2013
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COMPANY WATCH Pharmexcil invites comments from industry on EU directive notification Final notification to be issued by February 2021, 2013
Usha Sharma Mumbai overnment of India has officially deputed the Drug Controller General (India) (DCGI) as the competent authority in India for issuing written certificates on API export consignments, as required by the Directive 2011/62/EU of June 8, 2011 with amended Directive 2001/83/EC. In line with this, DCGI has shared drafted guidelines for issuing written confirmation on EU Directive with Pharmaceuticals Export Promotion Council of India
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(Pharmexcil). Pharmexcil has requested Indian pharma companies to share their concerns and suggestions on the checklist issued by the DCGI. Speaking exclusively with Express Pharma, Dr PV Appaji, Director General, Pharmexcil said, “We are going to meet DCGI for discussing the final notification on the EU directive guidelines. Hence, I request all pharma companies to share their concerns and suggestions, which we can represent from Pharmexcil.” Appaji continued, “Since we have limited time and as
the implementation date is July 2, 2013, we shall try to finalise the final notification before February 21, 2013. ”Industry sources have stressed their concerns over the 90-day period for granting the approval. They pointed out that if the facility has been already approved by the World Health Organization -GMP - COPP) (by DCGI), then there is no need for conducting inspection again.” Forecasting the serious business of API, Appaji commented, “China has already joined hands with the European Union lobby con-
cerning over APIs threat from India. I request any top five Indian pharma CEOs to come forward and we can organise a meeting with the Ministry of Commerce within a week to discuss the issues.” EU ambassador has asked the Indian embassy whether DCGI has communicated or informed to the industry on EU directives mentioning DCGI as the competent authority. Pharmexcil informed that Government of India has already been informed about this. u.sharma@expressindia.com
Q3 results posts ups and downs in India pharma sector Indian pharma companies have posted their third quarter results. Express Pharma highlights the results Lupin Lupin has reported its performance for the third quarter that ended on December 31, 2012. The company has reported a net sales grew by 37.6 per cent to ` 24,659 million during Q3 FY 2012-13, up from ` 17,917 million in Q3 FY 2011-12. Earnings before interest, tax, depreciation and amortisation (EBITDA) grew by 67.6 per cent to `. 6,314 million during Q3 FY 2012-13, up from ` 3,768 million in Q3 FY 2011-12. Profit before tax grew by 78.6 per cent to ` 5,550 million during Q3 FY 2012-13, up from ` 3,107 million. Net profits grew by 42.6 per cent to ` 3,352 million during Q3 FY 2012-13, up from ` 2,351 million. Commenting on the results, Dr Kamal K Sharma, Managing Director, Lupin, said, “We had a record quarter driven by strong operating performance and growth in the US. Importantly, we continue to improve on margins consistently."
Glenmark Glenmark Pharma has posted its Q3FY13 results where the company's total
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EXPRESS PHARMA
income increased 34 per cent Y-o-Y to ` 13.8 billion. Growth in the domestic business and Rest of the World (RoW) formulations sales were in positive mode. The company reported an Earnings before interest, taxes, depreciation and amortisation (EBITDA) margin of 22.9 per cent. EBITDA grew by 54.4 per cent Y-o-Y aided by favourable product mix and licensing income. Core EBITDA margin (excluding licensing income) was a robust 20 per cent. Adjusted Profit After Tax grew slower than EBITDA due to lower other income and higher depreciation. Excluding licensing income, Glenmark’s speciality business posted a robust 31.2 per cent Y-o-Y growth as the company made excellent gains in India and RoW. The India business grew by a 29.9 per cent vs industry growth of 9.1 per cent (as per AIOCD AWACS) during the quarter.
company recorded revenues of ` 1502.6 million as compared to ` 1417.5 million over the same quarter last year. The company’s domestic formulation business registered a growth of 11 per cent as against Indian Pharma Market (IPM) growth of 9.1 per cent during the quarter. Commenting on the performance, Suresh G Kare, Executive Chairman, Indoco Remedies said, “The Indian pharma market witnessed some slowdown during the last quarter but is expected to rebound back in the coming quarters. Indoco’s domestic business has performed better than industry and our strategies have paved well for growth in the coming quarters as well. On the international business front, the growth during the quarter was marginal due to slowdown in emerging market tender business but we envisage to close the year with better numbers.”
Jubilant Life Sciences Indoco Remedies The un-audited results of Indoco Remedies for the third quarter of the financial year 2012-13 were announced by the Board of Directors at their recently held meeting held in Mumbai. During the third quarter of FY 2012-13 the www.expresspharmaonline.com
The Board of Jubilant Life Sciences approved the financial results for the third quarter of the financial year 201213. In Q3 FY2013, income from operations was at ` 1,306 crore growing over 19 per cent YoY. This was led by volume increase of 23 per
cent. The earnings before interest, taxes, depreciation, and amortisation (EBITDA) stood at ` 263 crore, up by 24 per cent YoY with EBITDA margins at 20.2 per cent, compared to 19.4 per cent last year. The profit before exceptional items, tax and minority interest stood at ` 146 crore, higher by 44 per cent YoY. The reported Profit after Tax grew 134 per cent at ` 27 crore after considering the ` 71 crore impact of exceptional items. Normalised PAT was higher at ` 98 crore, up 27 per cent. Shyam S Bhartia, Chairman and Managing Director and Hari S Bhartia, Co-Chairman and Managing Director, Jubilant Life Sciences said:, “Our strategy of enhancing presence in identified international markets is delivering results with 28 per cent growth and high 73 per cent contribution to revenue mix. We believe this momentum is sustainable due to strong product pipeline and order book position along with leveraging benefits from vertical integration."
Sun Pharma Sun Pharmaceutical Industries has reported financials for the third quarter February 16-28, 2013
M|A|R|K|E|T ending December 31, 2012. Net sales/income from operations were reported at ` 2852 crores, a growth of 33 per cent over same quarter last year. Branded generic sales in India was at ` 788 crores, up by 13 per cent over Q3 last year. US finished dosage sales was at $276 million grew by 32 per cent (in $
terms) over Q3 last year. The international formulation sales at $73 million grew by 31 per cent (in $ terms) over same quarter last year. EBITDA was reported at ` 1261 crores seeing a 31 per cent growth compared to Q3 last year. The net profit was at ` 881 crores which witnessed a growth of 32 per cent over
Q3 last year. Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries said, “All our businesses continue to perform in-line with our expectations. The recent approval of our generic Doxorubicin HCl Liposomal Injection in the US reflects our technological
strengths in developing complex products. The acquisition of DUSA and URL’s generic business will further strengthen our presence in the US. Overall, we shall strive to remain focused on execution and building a business with consistent performance.” EP News Bureau – Mumbai
New rules on compensation to make clinical trials in India 'virtually impossible': ISCR Notification goes against consensus reached in stakeholder meetings on two crucial criteria, alleges ISCR he Indian Society for Clinical Research (ISCR) has strongly criticised certain rules in the Gazette Notification on Compensation released by the Ministry of Health & Family Welfare on January 30, 2013. In a statement published on its website on February 6, the ISCR spokesperson says that while it is fully supportive of the need to create a
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more robust and regulated environment in India for the conduct of clinical research which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected and therefore welcomes a policy on compensation, some of the rules in the compensation gazette notification will make the continuing conduct of high quality, scientifically valid clinical trials in India virtually impossible, negatively impacting the a v a i l a b i l i t y of scientific data to assess
the benefits and risks of new medicines for the Indian population. Commenting on the sequence of events leading upto this Gazette Notification, the ISCR release points out that it was actively involved, as were other stakeholders including not-forprofit- organisations, bio pharma companies and CROs, academia and healthcare institutions, in providing its feedback to the Draft Notification on 'Compensation in case of study related injury or death
in clinical trials,' which was published in November 18, 2011 and subsequently participated in task force meetings (March 18 and April 29, 2012) set up by CDSCO to discuss the comments and finalise the guidelines. However, while much of the text in the Gazette Notification is along anticipated lines, two of the listed criteria for determination of eligibility for compensation are contrary to the consensus reached in the stakeholder meetings, and some of the other listed criteria remain
IS LOOKING FOR Perrigo is a leading global healthcare supplier based in Allegan, Michigan, U.S.A develops, manufactures, markets and distributes over-the-counter (OTC) and active pharmaceutical ingredients (API). Every second of every day 1400 people in the US are taking a Perrigo product. Fortune magazine named Perrigo as one of 2011’s Fastest Growing Companies. More than 8,700 Perrigo employees around the world commit themselves each day to the important mission of making Quality Affordable Healthcare Products. Lead Pharmacokinetics (Biopharmaceutics) For our Biopharmaceutics group, we are seeking suitable profiles of highly motivated and qualified professional that could bring in expertise, resourcefulness, and creative approach to direct a diligent pharmacokinetic (PK) program that is led from our site based in Ambernath , Thane, Maharashrta. The job entails global responsibility of managing the PK program for various Perrigo sites and its partnerships covering prescription (Rx) and consumer healthcare products (CHC). A unique blend of scientific and managerial experience in pharmacokinetics, bio-analyses and biostatistics, coupled with effective leadership skills is required. Masters or PhD in Pharmaceutical / Biopharmaceutical Sciences or closely allied life sciences discipline combined with more than 10 years of research and management experience in the pharmaceutical industry in progressive leadership roles. Regulatory Affairs Manager For our API R&D Regulatory Affairs group based in Ambernath , Thane, Maharashrta. , we are seeking suitable profiles with 6-9 years of experience in compiling Drug Master Files in different regions (including USA, Europe, EDQM, Japan and other territories) , submitting, answering deficiencies and maintaining the same through the life cycle of the API in accordance with current guidelines and Chemagis' strategy and requirements. Regulatory support to API R&D and to customers of APIs produced or developed at contract manufacturing site. Ph.D. in organic chemistry. Experience/knowledge in modern analytical chemistry . Knowledge of the current regulatory requirements for Drug Substances. Interested candidates may send resume at career.pai@perrigo.com OR Apply at www.perrigo.com For more company information visit: Facebook Address: www.facebook.com/perrigocompany Twitter ID: PerrigoCompany
February 16-28, 2013
www.expresspharmaonline.com
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M|A|R|K|E|T controversial. These include no distinction being made between study-related injuries and non-study related injuries, the use of placebos in placebo-controlled trials, the lack of any arbitration mechanism in case of disagreement on causality/quantum of compensation and the lack of clarity on who constitutes the Expert Committee constituted by the Licensing Authority. With particular reference
to the clause on compensation to be paid in the case of an injury or death due to an investigational product not having its intended therapeutic effect or due to a placebo controlled trial, ISCR believes that this will have a far reaching impact on organisations and academic institutions, both Indian and multinational, in risking doing clinical trials in India as they go against the tenets of science. Referring to current ongo-
ing efforts by the US FDA to discuss with industry experts how a speedier pathway to approve drugs and biologics for serious and life-threatening conditions with unmet medical needs can be constructed (http://medcitynews.com/2013/02/fdahearing-questions-how-to develop- fast-lane-for-drugdevelopment-for-unmet-medicalneeds/#ixzz2K0yMeekn), the ISCR release points out that India has 16 per cent of
the world’s population and 20 per cent of the global disease burden and yet, less than two per cent of global trials take place in India. It is only through clinical research that we will be able to find newer and better medicines to treat our population and reduce mortality rates for various diseases, including those unique to our part of the world, according to the release. EP News Bureau – Mumbai
Medicines Compendium expands global reach through new expert committees, enhanced website Experts from Argentina, Bangladesh, Brazil, China, Korea, Pakistan and the UK reflect growth of the MC esponding to the evergrowing need for global public quality standards for medicines, the United States Pharmacopeial Convention (USP) announced the formation of three new Expert Committees for its Medicines Compendium (MC) and an expanded and enhanced website for the online-only compendium. In addition to the initial Medicines Compendium— South Asia (MC-SA) expert committee formed in 2011 and chaired by Dr Antony Raj Gomas, USP has added the Medicines Compendium— East Asia (MC-EA) Expert Committee, chaired by Dr Jaisheng Tu; the Medicines Compendium—Latin America (MC-LA) Expert Committee, chaired by Dr Maria Ines Rocha Miritello Santoro; and the Medicines Compendium—Biologics (MC-BIO) Expert Committee chaired by Dr Dhananjay Patankar. The first three expert committees comprise experts from the region on chemical medicines and excipients.
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The MC-BIO expert committee comprises experts on biologics and biosimilars from Argentina, Brazil, China, South Korea, and the UK, as well as biologics experts from India who were members of original MC-SA Expert Committee. USP may add up to four more MC Expert Committees based in other regions of the world and/or focusing on other scientific areas. The MC-SA Expert Committee also has expanded its membership to include experts from Pakistan and Bangladesh. A complete list of expert committee members can be found on the MC website. USP also announced the expansion and enhancement of the MC website to incorporate extensive interactive capabilities that support stakeholder comments. New website functionality allows users to navigate more easily, instantly upload comments anonymously, and view monographs and comments on-screen in a new in-line format. In addition, expert committee meetings will be posted and users will be able to share and save content with printing and PDF tools. “I am gratified by the
advances of the Medicines Compendium during its first year and a half. The MC’s innovative approaches to monograph development allow USP to create monographs using a Reference Procedure that may be used to test articles from multiple manufacturers. The MC development process also has paved a way to a more rapid and effective approach to developing standards. The work of the Medicines Compendium Expert Committees, supported by USP staff in India, Brazil, China and the US, has created a strong foundation upon which we are now able to build,” said Roger L Williams, Chief Executive Officer, USP. To date, approximately 70 monographs have been authorised for use, and over 30 more monographs are near final authorisation in the MC. An additional 180 more are in the initial for development phase. Among those authorised are monographs for Hepatitis B Vaccine; Esomeprazole Sodium, used to control acid in the stomach; and Pegfilgrastim, a treatment used to help patients fight infection when undergoing
chemotherapy. Also recently authorised is a monograph for Rituximab, a monoclonal antibody used in the treatment of lymphoma, rheumatoid arthritis and other autoimmune disorders. This monograph is the first public standard for a monoclonal antibody available in the world. Among the other vaccine monographs currently under development is Haemophilus Influenza Type B Vaccine. Both vaccines are included on the List of World Health Organization Essential Medicines. Monographs also are in development for various dosage forms of Metamizole, an analgesic used extensively in Brazil and South America. The MC is a free, online resource of quality standards for medicines approved in any country. It was launched in July of 2011 with one Expert Committee (EC) based in South Asia (India). The MC provides monographs, general chapters, and reference materials for chemical and biologic medicines and their ingredients, including drug substances and excipients. EP News Bureau – Mumbai
Marck Biosciences takes private equity route with Tata Capital arck Biosciences, manu- Hence, Tata Capital will hold said, “It is a sustained in for further funding To invest ` 80 crores in facturer and marketer of around 19 per cent to 22 per growth phase for us at through debt route. We M new project sterile liquids pharmaceutical cent combined stake in Marck Biosciences as we are expect returns from the dosages using the Blow-FillSeal (BFS) technology, has sold a minority stake to Tata Capital Healthcare Fund. Tata Capital will invest ` 45 crores in the company and has picked up a 13 per cent stake in Marck Biosciences. IFCI Venture’s six per cent stake will also be acquired by Tata Capital Healthcare Fund.
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Marck Biosciences. Marck Biosciences is targeting a top line growth of 62 per cent while the PBDIT (profit before interest, depreciation & taxes) is targeted at 37 per cent and net profit to reach at 17-18 per cent. Bhavesh Patel, Managing Director, Marck Biosciences www.expresspharmaonline.com
investing ` 80 crores in the new expansion project. The fund infusion from Tata Capital will be invested for further expansion of capacities of the new project which will have state of the art technology. Our entire project cost is expected to be around Rs 80 crores and hence we will also be going
funds infused within six to eight months.” Marck Biosciences is actively seeking opportunities for growth and expansion in both markets, domestic and international. Hence the expansion of production facilities, product portfolio and markets becomes vital. EP News Bureau – Mumbai February 16-28, 2013
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Glenmark initiates IND enabling studies of novel monoclonal antibody targeting OX40 GBR 830 is the first antagonistic antibody targeting OX40 and is a potential Global First-inclass molecule l e n m a r k Pharmaceuticals has announced the discovery and initiation of investigational new drug (IND) enabling studies of a novel clinical development candidate, GBR 830, an anti-OX40 monoclonal antibody. GBR 830 has been discovered and developed by the Glenmark Biologics Research Centre
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February 16-28, 2013
located in La Chaux-deFonds, Switzerland. GBR 830, an anti-OX40 monoclonal antibody is a potential Global First-in-class molecule. OX40 is a well known target and the development of OX40 antagonists has been very challenging. Glenmark has achieved a significant milestone with the successful generation of an antagonistic OX40 monoclonal antibody coupled with generation of data validating the role of OX40 in autoimmune diseases. GBR 830 shows great promise to emerge as a valuable therapeutic option to
GLENMARK HAS ACHIEVED A SIGNIFICANT MILESTONE WITH THE SUCCESSFUL GENERATION OF AN ANTAGONISTIC OX40 MONOCLONAL ANTIBODY COUPLED WITH GENERATION OF DATA VALIDATING THE ROLE OF OX40 IN AUTOIMMUNE DISEASES treat patients suffering from immune pathologies such as autoimmune diseases like
www.expresspharmaonline.com
rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).
Commenting on this milestone, Dr Michael Buschle, Chief Scientific Officer and President Biologics, Glenmark Pharmaceuticals mentioned, “GBR 830 is a tremendous achievement for us. No antagonistic antibodies targeting OX40 are currently in clinical stage of development. We are confident that the antibody expertise and product development capabilities of the Switzerland Biologics Research Centre will continue to enrich the Glenmark discovery pipeline.” EP News Bureau – Mumbai
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M|A|R|K|E|T DEAL TRACKER
M&A activity in pharma sector focuses on expanding product offerings January 2013 registers slight increase in volume terms and decrease in value terms Mergers and acquisitions
M&A (including private equity) trend analysis
3
2 11
16
2 5
3
14
6 6
22
22
24
3 12
6 4
1 3
3 2 9
19
18
16
18
!
"
#! $ !%!
& '
Source:
Top M&A deals (Jan 2013) Rank Date
Target
Acquirer
Deal value ($m)
1
Jan 22, 2013 MAP Pharmaceuticals, Inc. (US)
Allergan, Inc. (US)
958.00
2
Jan 23, 2013 Uteron Pharma Holding SA (BE)
Actavis, Inc. (US)
305.00
3
Jan 24, 2013 Inspiration Biopharmaceuticals, Inc. & Ipsen S.A.- OBI1 Baxter International, Inc.
185.00
4
Jan 30, 2013 BioClinica, Inc. (US)
JLL Partners (US)
123.00
5
Jan 18, 2013 BioVectra, Inc. (CA)
Questcor Pharmaceuticals, Inc. (US)
100.50
6
Jan 16, 2013 Guilin Tianhe Pharmaceutical Co., Ltd. (CN)
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (CN)
92.90
7
Jan 14, 2013 Shanghai Zerun Biotechnology Co Ltd (CN)
Yunnan Walvax Biotech Co., Ltd (CN)
49.20
8
Jan 15, 2013 Shanghai Celgen Bio-Pharmaceutical Co., Ltd. (CN)
Devont Asset Management Ltd (CN)
48.17
9
Jan 31, 2013 Pharmaxis, Ltd. (AU)
NovaQuest Pharma Opportunities Fund III, L.P. (US) 40.00
10 Jan 7, 2013 Source:
Zacharon Pharmaceuticals, Inc. (US)
BioMarin Pharmaceutical, Inc. (US)
10.00
2
1
2
1 1 8
1 1
9 15
18
11
1
9
12
3 25
15
1 5
18 11
! " !#
$ !
( )
Venture financing trend analysis
%# & #'#
Top venture financing deals (Jan 2013) Rank
Date
Target
Investors
1
Jan 15, 2013
Versartis, Inc. (US)
Aisling Capital; Index Ventures LLP; New Leaf 25.00 Venture Partners, LLC; Advent Life Sciences Fund
2
Jan 3, 2013
Gradalis, Inc. (US)
Undisclosed Investors
3
Jan 28, 2013
Ocular Therapeutix, Inc. (US)
Polaris Venture Partners; Versant Venture Management LLC; SV Life Sciences; SPARTA Capital 23.80 Partners, LLC; Ascension Health Ventures, LLC
4
Jan 4, 2013
Solstice Biologics, LLC (US)
venBio LLC; Aeris Capital AG
5
Jan 14, 2013
Aileron Therapeutics, Inc. (US)
Apple Tree Partners; Excel Venture Management; Lilly Ventures; The Novartis Venture Fund; Roche 12.00 Venture Fund; SR One
Deal value ($m)
24.00
18.00
Source:
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Venture funding Companies in the pharma sector raised $365.1 million during December 2012, against the previous six months’ average of $357.4 million. In terms of volume, the sector recorded 17 venture funded deals, compared to the previous six months’ average of 25 transactions.
Notes and definitions
Source:
22
M&A activity in the pharmaceutical sector continued to focus on expanding product portfolios as companies were looking for opportunities to generate new pipelines. In line with the above trend, Allergan agreed to acquire MAP Pharmaceuticals, a US-based biopharmaceutical company, for approximately $958 million. With this transaction, Allergan will gain access to MAP Pharmaceuticals’ Levadex, an orally inhaled drug for the potential acute treatment of migraine in adults, which is under review with the US Food and Drug Administration (FDA). Allergan will continue the development of Levadex as a potential acute treatment for migraine and use MAP Pharmaceutical’s proprietary drug particle and inhalation technologies to generate new pipeline opportunities. In another key deal, US-based Watson Pharmaceuticals acquired Uteron Pharma, a Belgium-based development company, dedicated to female healthcare, for approximately $305 million. The acquisition of Uteron expands Watson’s global brands pipeline for women’s health products, including two potential near-term global commercial opportunities in contraception and infertility; and one novel oral contraceptive, projected to launch globally in 2018. This transaction is a first step for Watson to enhance its branded opportunities globally, while creating near term revenue for global brands and further expanding its women’s health development portfolio. M&A activity in the pharma sector slightly increased in volume terms and decreased in value terms, when compared to the average of previous six months’ (Jul 2012–Dec 2012). According to Datamonitor's Medtrack database, the pharma sector recorded 36 M&A transactions in January 2013, against the previous six months’ average of 35.6 transactions. In value terms, the sector recorded deals worth $1.9 billion against the previous six months’ average of $3.2 billion. The Indian pharma sector witnessed one deal during January 2013, against the average of zero deals over the previous six months in which India-based Fidelity Growth Partners made an investment of $5.49 million in Richcore Lifesciences, a biotechnology company.
www.expresspharmaonline.com
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. Inhouse 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. For more information, visit us at www.medtrack.com
Definitions 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.
February 16-28, 2013
M|A|R|K|E|T
EVENT BRIEF 4th Annual Biosimilars Date: March 6-8, 2013 Venue: Mumbai, India Summary: With over 100 attendees in 2012, the 4th Annual Biosimilars is all set to be bigger and better with exclusive focus on process development and analytics to suggest best strategies for developing the first commercially successful molecule. Designed under the guidance of the strategic advisory members, the three-day strategic meet will be a platform to understand practical solutions to minimise the risks associated with the highest spend areas of the biosimilars development cycle.
iPHEX 2013 Date: April 24-26, 2013 Venue: Bombay Exhibition Centre Summary: Pharmexcil has announced the launch of iPHEX
2013, India’s own pharmaceutical show under the support of Ministry of Commerce and Industry, Department of Commerce, and Government of India. Over 400 leading Indian companies are expected to showcase the best of pharma products at the event. iPHEX
2013 will see 5,000 business visitors including overseas buyers and drug regulators. Further, the presence of large number of drug regulators from overseas market is expected to help Pharmexcil and its members to promote the quality and affordability aspect as envisaged in
‘Brand India’ pharma campaign. Contact details: Sanika Patil ProjectManager – iPHEX 2013 Tel: 91.11.23324288 M: 91.9582758812 E-mail: sanika@falcon-mail.com
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Process Engineering General Planning Implementation
Global Pharma Regulatory Summit
Validation/Qualification
Date: March 11-15, 2013 Venue: Mumbai Summary: 2nd Annual Global Pharma Regulatory Summit will focus on the recent regulatory amendments for 2013. The conference agenda includes a pre-conference summit on GDUFA, US focused day, EU focused day, ROW focused day and a workshop on eCTD Lifecycle management. Some of the confirmed speakers for this summit include Ashish Kohli Pfizer UK, Naveen Kumar Jain - Dr Reddy’s, Dr Rajkiran Jain - Zydus Cadila, Dr Hoss Dowlat - PharmaBio Consulting, Germany, Jasbir Chohan - PEC, UK and many more.
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Contact details: Tel: +91 (0)22 40461466 e-mail: conferencesindia@ubm.com Website: http://www.pharmaregulationindia.com/?utm_campaign=M EDIAPARTNER&utm_medium=EVENTLISTING&utm_so urce=EXPRESSPHARMA
February 16-28, 2013
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POST EVENTS STEM-2013 redefines stem cell research in India Researchers from France, Argentina and Brazil provided useful inputs about the regulatory scenario Sachin Jagdale Bangalore he ninth edition of STEM 2013 which recently concluded in Bangalore saw scientists from across the globe attending the event. The annual meeting of the Society For Regenerative Medicine Tissue Engineering (SRMTE), STEM 2013 was a forum for basic scientists, clinicians, students, law firms and technology companies to exchange ideas and present advances in the area of stem cells and regenerative medicine. This was slightly different from a
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usual scientific meeting due to the breadth of topics covered in the area of regenerative medicine. There was also ample time for deliberation of various issues including regulatory hurdles faced by cell therapy companies in India. Researchers involved in cell-based therapies from different countries like France, Argentina and Brazil provided the useful inputs about the regulatory scenario for these therapies in their home countries. As a result of these deliberations SRMTE provides useful inputs to the regulatory agencies for approval of cell based therapies. “This meeting reminded me of the World Stem Cell Summit held in the US in December 2012, which also
provided a forum for stem cell companies, regulators and patient advocates to discuss issues related to stem cells. STEM 2013 also had excellent presentations on basic biology of stem cells, results from clinical trials involving stem cells as well as intellectual property management and venture capital (VC) funding landscape for stem cell companies. Presentations by Indian researchers also showed that they are aware and tackling these research and therapy issues with a similar understanding and enthusiasm as researchers in other countries,” said Dr Vivek Tanavde, Principal Investigator, Agency for Science, Technology and Research
(A*STAR), Bioinformatics Institute (BII), Singapore. India has one of the most talented pool of scientists to its credit and holds potential of becoming stem cell research hub of the world. However, according to Dr SGA Rao, CMD, International Stem Cell Services, unless the Indian Government proactively supports stem cell research, Indian scientists would find it difficult to prove themselves in the international arena. Rao said, “Stem cell therapy is slowly and steadily shifting from hype to reality. Stem cells have shown a great promise in the treatment of some of the disease categories. However, the Government should come clean over guidelines/regulations for stem cell research. The Government still considers stem cell research as an experiment. This approach has hindered a growth of stem cell research in India.” While giving low-downs of stem cell research in India, Dr Aroop Kumar Dutta, Managing Director, ExCel Matrix Biological Devices, said, “There has been a major development in the awareness about stem cell mostly due to media in the past decade. On the R&D front, initiatives are restricted to large corporates due to the limitations of an investment in advance and infrastructure needed. All small stakeholders are left with the choice of unscrupulous practices like injecting some kind of stem cell population hoping to make a clinically observable difference. Patients will always be desperately hopeful.” He adds, “My suggestion is to make a compulsory audit of procedure and techniques of therapy (mandatory by law) once an organisation undertakes propaganda/ advertising for 'stem cell therapy' in any form in any type of media. This will deter those who are not law abiding from fleecing patients with this 'experimental therapy' and government grants in the name of research and development.” Sachin.jagdale@expressindia.com
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EXPRESS PHARMA
www.expresspharmaonline.com
February 16-28, 2013
M|A|R|K|E|T
GIPC-2013 sees congregation of IP experts More than 300 speakers from 30 countries participated in the event Sachin Jagdale Bangalore lobal Intellectual Property Rights Conference (GIPC2013) was recently held in Bangalore. ITAG Business Solutions in collaboration with Sughrue Mion PLCC, US and Institute of International Trade were the organisers of the fifth Global IP Convention. The objective of the conference was to create an awareness on intellectual property (IP) compliance for its effective protection and enforcement. IP valuation, commercialisation, technology transfer, litigation, counterfeiting, analysing the techno-legal and commercial solution to all associated problems in the field of intellectual property were the main focus areas throughout the conference.
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February 16-28, 2013
Attended by corporate bigwigs both from India as well as the US, the conference witnessed debates on complex issues like patentability of business methods, software and emerging field of technologies namely electronics, telecommunications, green technologies and pharmaceuticals. GIPC is the biggest of its kind event on IPR that was held in India. More than 300 speakers from 30 countries participated in the event.
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GIPC-2013 provided a forum to discuss latest tools, technologies and processes. Live streaming through webinar was the highlight of the event. ITAG succeeded in roping in Government of India, local and national chamber of commerce and leading Indian companies. A huge contingent of corporate India participated in the conference, which is being looked upon as an opportunity to explore IPR related business collaborations.
Milind Sathe, Deputy General Manager, Unichem Laboratories, said, “The objective of creating an awareness on IP compliance has been successfully achieved in the conference. The conference provided one of the effective networking and business development platforms as well. The presence of about 300 speakers and their excellent delivery on IP matters in the gathering was a phenomenal success.� Sachin.jagdale@expressindia.com
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Bangalore INDIA BIO 2013 ends on a promising note 110 speakers, 878 delegates, over 500 organisations and 100 exhibitors from various verticals of life sciences industry participated in the event angalore INDIA BIO 2013 - India’s Biotech forum renowned for calibrating the pulse of the biotechnology industry recently concluded on a high note. The threedays brought together global leaders from the life sciences sector for a comprehensive overview of this rapidly changing industry envisaging India as a $100 billion biotech hub. The event was organised by the Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka, Vision Group on Biotechnology, MM Activ Sci-Tech Communications. The forum consisted of 22 sessions with participation from 110 speakers, 878 delegates, over 500 organisations. 100 exhibitors from various verticals of life sciences industry like biopharmaceuticals, bio-suppliers, bio-informatics, bio-medical devices participated in the exhibition and attracted over 3000 plus business visitors. The gathering was attended by delegates from more than 20 countries including Scotland, the US (Georgia), Canada (Alberta) and Australia (Victoria) and also from Atlanta, Missouri from the US, Germany, the UAE, France, the UK, Spain, Israel, Mexico, Japan, Malaysia and Singapore and European and South East Asia countries. Seven Indian states, Andhra Pradesh, Tamil Nadu, Uttar Pradesh, Maharashtra, Kerala, Haryana and Assam also participated in the exhibition. Distinguished Speakers at Bangalore INDIA BIO 2013 included Dr Kiran Mazumdar Shaw, Chairperson, Karnataka Vision Group on Biotechnology; Chairman and Managing Director, Biocon; Prof K Vijay Raghavan, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India, Prof Charles ffrench-Constant, Director, Centre of Regenerative Medicine, University of Edinburgh, Scotland, Charles French; Dr Karen Bernstein - CoFounder and Chairman, BioCentury, US; Prof Anil K
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Gupta, Executive Vice Chairperson, National Innovation Foundation – India, Professor of Indian Institute of Management (IIMA); Prof David Koelle, Professor of Medicine, Adjunct Professor, Global Health and Laboratory Medicine, University of Washington; Affiliate Investigator, Fred Hutchinson Cancer Research Center; Affiliate investigator, Benaroya Research Institute, US. Conveying his pleasure on the successful completion of the 13th edition, ISN Prasad, IAS - Principal Secretary, Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka said, “We are pleased with the outcome of this edition of Bangalore India Bio. A number of future initiatives are being looked at to promote sustainable collaboration between different stakeholders committed to improving quality of life from across India and globally creating opportunities and encouragement for young scientists and researchers to engage in ‘Biotech for a better tomorrow.’ Prasad further said, “Karnataka is proud to be the pioneering state involved in promoting biotechnology in a big way. Collaborations and MoUs will play a significant role to demonstrate a collective commitment to ensure Karnataka and India are more competitive and continue to benefit from rapidly growing global biotech industry.” Dr Kiran MazumdarShaw, Chairperson, Karnataka Vision Group on Biotechnology; Chairman and Managing Director, Biocon said, “Bangalore India Bio has grown in stature, we have seen a huge surge in number of delegates, numbers of country participation, the number of forums we have created within this conference, the partnering forums, the poster sessions, both the exhibition and the conference have taken a new hue. It has evolved with times, it has become far more professional, far more serious. We are using this as a platform for all stakeholders to really address some of the key chalwww.expresspharmaonline.com
lenges and issues that the Indian biotech sector faces, the challenges in terms of international perception. I think it is making a huge difference to how the Indian biotech sector is now being perceived.” Commenting on the event Dr K Vijay Raghavan Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India said, “Entrepreneurs in biotech space, Government and the academia need to work together and Bangalore India Bio has a very invigorating environment to see that happen.” David Wetherell, President and Chief Operating Officer, Burrill Healthcare Venture and Private Equity Funds US said, “It has been a great experience at Bangalore India Bio. Clearly in India, you probably have the greatest concentration of human and intellectual capital in the world and lot of this is concentrated in Bangalore. This has come out very clearly in Bangalore India Bio.” Key highlights: Three industry reports were released. They were ‘Indian Biotechnology: The roadmap to the Next Decade and beyond by ABLE’; ‘Opportunities for Fermentation Industry & Biotechnology’ by ABLE and Report on ‘Funding Your Science Idea’ of Atharva Life Sciences Consulting. Two MoUs were signed with KBITS (Government of Karnataka), one by Scottish Development International (SDI), an international economic development arm of the Scottish Government and the other by the Georgia Department of Economic Development, Atlanta, Georgia, US. Bangalore India Bio 2013 facilitated 372 B2B meetings through the Bio Partnering tool – InterlinX. Bio-Excellence Awards were presented at the event. In Biopharma and Health Care category, Serum Institute of India bagged the award and Stempeutics Research bagged the Emerging Company of the year award. In the Agri-Biotechnology category, Metahelix Life Sciences bagged the award. In the Bioservices category
Quintiles Research India received the award and the emerging company award was bagged by Anthem Biosciences. Bio-Industrial category was bagged by Praj Industries. In the Bioinformatics and Systems Biology categories, the award winner was Strand Life Sciences and the Emerging Company of the year was Xcelris Labs. Exhibition awards were also presented. Poster presentations were held, where-in, young minds were given an opportunity to showcase their innovative ideas. Over 45 entries were received, of them 35 posters were selected. The best poster awards were bagged by G Suhasa, BMS College of Engineering, Bangalore; Neeraj Kumar Garg from Punjab University won second place and third places was bagged by Pavithra N of PES Institute of Technology. A special recognition was given to Nisha GJ of Dayanada Sagar College of Engineering and Nidhi Malviya, Al-Ameen College of Pharmacy. A workshop was conducted by NSRCL- IIM Bangalore to nurture entrepreneurial opportunities in Biotechnology a boon especially for aspiring bio-entrepreneurs and researchers. Preliminaries of state level ‘BioQuiz 2013’ was conducted across Karnataka where-in large number of students participated and the four finalists battled it out in the Grand Finale of ‘BioQuiz 2013’. The awards were presented by Former Indian cricketer Anil Kumble. The first place was won by Arun Panchapakesan and Vijay Ramesh from RV College of Engineering Bangalore. The second place was won by St Aloysius College, Mangalore represented by Gunjan Gupta and Sulakshana K. The third place was bagged by University of Agricultural Sciences (UAS), Dharwad, Belgaum represented by Shwetha Kumari and Sambhavana. The fourth place was bagged by Sri Jayachamarajendra College of Engineering (SJCE), Mysore represented by Sheshadri SA and Chandan Pande. EP News Bureau- Mumbai February 16-28, 2013
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High Potent Drugs-2013 debates regulatory complexities Conference in Mumbai brought together international and domestic experts who discussed high potent drugs related R&D and manufacturing issues Sachin Jagdale Mumbai n the pharmaceutical industry potency is the measure of drug activity. Such drugs generate large response at lower concentrations. As these drugs are sensitive in nature, technology used in their manufacture become crucial for the manufacturers. Recently concluded, High Potent Drugs-2013 conference in Mumbai brought together international and domestic experts who discussed high potent drugs related R&D and manufacturing issues. Speakers talked about things that may decide the future direction of domestic and global high potent drugs manufacturing industry. As regulations have always remained one of the most challenging aspects for the pharma industry, discussions were focussed on overcoming the regulatory complexities involved in high potent drugs and understanding specific documentation requirements to ensure compliance with global regulatory standards. Audiences were updated on the latest cGMP requirements for potent drugs to ensure compliance with the global standards. Technology predominantly remained the focus during the conference. Speaking about the event, Vishal Sharma, CoFounder and Director, Vienni Training and Consulting LLP said, “It is a need of the hour for Indian drug manufacturers to come together on a neutral platform(s) and share knowledge. India has already emerged as a global player in pharmaceutical industry. In order to sustain this momentum it is important for us to develop mechanisms to come together and discuss technical issues threadbare.� The strategic meet covered a wide gamut of topics that concern advances in high potent drug development, manufacturing and facility design to ensure swift market introduction of cost-effective and consistent quality high potent drugs. A
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workshop was also held on facility design and engineering control requirements for high potent drugs. At High Potent Drugs-
2013, senior industry experts such as Justin Mason from Safebridge, Dean Calhoun from Affygility Solutions, Rino
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Coladangelo from Rephine, Dr Bhaswath Chakraborty from Cadila Pharmaceuticals and Jatin Gajjar from Famy Care, shared valuable insights on significant approaches in the high potent drug domain. The participation
of presidents, directors, Heads of R&D, manufacturing, formulations and containment equipment from across the globe made the event a highly successful one. Sachin.jagdale@expressindia.com
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W H AT ’ S INSIDE
MANAGEMENT INSIGHT FOR MANAGING PHARMA
Great expectations from Budget 2013-14 PG 31 To poll or not to poll PG 36
RESEARCH 38 PHARMA ALLY 63 PHARMA LIFE 72 28
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February 16-28, 2013
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India seems to be in no mood to buckle down and has hardened its stance on ensuring access to expensive patented drugs which have been largely unaffordable to its population. And it is now resorting to compulsory licensing, a tool it had in its kitty since long. The WTO’s Ministerial Conference in Doha adopted a TRIPS and Public Health Declaration back in 2001 affirming that the agreement should be interpreted in a manner that does not prevent its members from taking suitable measures to support the right to health and access to medicines for all. The Declaration clarified: “In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.” Thus it is the onus of every country to ensure that its patent regime suits its own needs and is in larger public interest while being effectively regulated and enforced in a pro-competitive manner (including aligning it with industrial policies to encourage domestic production of generics) emergency situations, epidemics, public noncommercial use, tackling anti-competitive practices or as outlined by the country’s law could be some of the grounds for issuing a license.
A boon for developing countries? Analysts argue that although developed countries such as the US, Canada and Italy have been issuing CL on grounds of security or inadequate working of the patented product in the country, it is when developing countries do the same, they come under the scanner. Says TC James, IPR specialist and Consultant at Research and Information System for February 16-28, 2013
KRISHNA SARMA
TC JAMES
KAMAL SAGGI
Managing Partner Corporate Law Group
Consultant, Research and Information System for Developing Countries
Professor of Economics, Vanderbilt University
Legitimate and imminent health emergencies that require making exceptions to intellectual property rights can be accommodated under the international framework, but only after exhausting all other efforts
The Indian patent office received three applications for CL post 2005 after the product patent regime came into force, but it rejected two of them for want of fulfilment of procedures laid down in the law. Only one CL has so far been granted
CL is an important tool for developing countries to improve access to patented drugs that sell at high prices. In general, India is in better position to use CL than most developing countries with similar per capita income since it has a well developed local pharma industry
Developing Countries (RIS), “The Indian patent office received three applications for CL post 2005 after the product patent regime came into force, but it rejected two of them for want of fulfilment of procedures laid down in the law. Only one CL has so far been granted. The Indian Patent Office thus does not issue a CL lightly.” Referred here is the landmark ruling by the Indian Patent Office over Bayer’s liver and kidney anti-cancer drug Nexavar in March 2012 which allowed Natco Pharma to manufacture the generic version of the drug, albeit for domestic consumption. Natco cited the high cost of the drug ($5,500 per month) that made it unaffordable to Indians. In its ruling the patent office wrote, “The mandate of the law is not just to supply the drug in the market, but to make it available in a manner such that substantial portion of the public is able to reap the benefits of the invention. If the terms are unreasonable, such as high cost, availability is meaningless.” Natco Pharma is now manufacturing the drug at $171 per month, 97 per cent
lesser than its initial price. In a paper published last year, Eric Bond and Kamal Saggi, from the Department of Economics at Vanderbilt University espouse the role of CL in developing countries on grounds of the countries inability to reverse engineer patented drugs by innovator companies which in turn create barriers to consumer access to medicines. They argue that while price control and CL are complementary tools to enable greater access to medicines from the perspective of developing countries, stricter price control in isolation might dissuade Big Pharma from entering emerging markets. A stricter CL policy allows developing countries to set a more stringent price control(under entry) while also shifting the patent holder's preference in the favour of the entry. It helps make voluntary licensing less attractive to the patent holder thereby helping it extract greater share of the surplus. “CL is an important tool for developing countries to improve access to patented drugs that sell at high prices. In general, India is in better position to use CL than most developing countries with
similar per capita income since it has a very well developed local pharmaceutical industry,” reiterates Saggi. However, Bond and Saggi also state that a CL can only benefit developing countries if they either improve the terms at which voluntary licensing occurs or undertake measures to help the patent holder to switch from licensing to entry. Both policy instruments (price control and compulsory licensing) have different effects on how a patent holder chooses to work its patent in the country.
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Big Pharma’s woes, challenge for generic companies The paper by Bond and Saggi, however, points out a shortfall that most developing countries who have issued CLs have faced- the quality of the generics manufactured. After Thailand issued a CL on the HIV/AIDS drug Kaletra (originally from Abbott), the quality of the drug produced by the Thai government pharmaceutical organisation (GPO-vir) proved to be substandard. Brazil, which in 2007 issued a CL on the HIV/AIDS medicine Efavirenz, after failing to EXPRESS PHARMA
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negotiate a price with Merck was also unable to manufacture the drug for two years due to its lack of technological knowhow, during which it imported the drug from India. “When issuing a CL, the government must take into account whether or not indigenous production would be of sufficiently high quality. If it is not, you can end up replacing limited access to a high quality product by greater access to a lower quality one,” adds Saggi. It also needs to be noted that both the countries have issued CLs for drugs under their government programme unlike India where the onus of manufacturing is on a company. So far there have been no issues around quality of Sorafenib by Natco Pharma. Quality aside, planning is also crucial. Cautions Raghava Saha, who headed the P a t e n t Fa c i l i t a t i n g Centre, TIFAC, Government of India, “A reasonable gestation period is needed for converting the patent(s) into marketable drugs which are duly approved by D C G I . Additionally, it has to be ensured that the desired production levels will be achieved and the requirement of public will be met by adequate supply at reasonable price. A monitoring system will have to be in place.” Big Pharma on the other hand is at odds with the unfolding of events in the Indian pharma landscape. In a recent hearing before the IPAB, Bayer’s plea against Natco Pharma was dismissed even as it argued that it did not get enough time to ‘work’ its patent over and above the three years entitled under the Indian law under which a generic competitor has to wait three years after the grant of a patent before a compulsory license to market a more affordable generic version can be filed. Roche, whose breast cancer drug Herceptin is one of the three drugs recommended for a CL signed a commercial deal with Emcure Pharma, soon after March 2012 to market the drug under a new name. However, the price difference is not substantial and
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the drug continues to remain unaffordable. The International Federation of P h a r m a c e u t i c a l Manufacturers & Associations (IFPMA) a global non-profit NGO representing the research-based pharma industry asserts that systematic issuance of CL sets a negative precedent thus dissuading investment in R&D of new medicines that address unmet medical needs. It recommends tiered pricing or voluntary licensing as effective and sustainable strategies, both medically and economically. The Pharmaceutical Research and Manufacturers of America (PhRMA) has even gone a step ahead and said that if this continues, the developing world may no longer have generic medicines as the impetus to invest in R&D would cease. It also takes a strong objection to the fact
that 'working' a patent requires a company to manufacture within India and considers it to be at loggerheads with India’s TRIPS commitment.
On the right track? While it was NATCO who earlier filed the application for CL, the latest move is an outcome of suggestions by an expert committee made to the Department of Industrial Policy and Promotion (DIPP), responsible for policy decisions regarding intellectual property rights. Madhukar Sinha, Professor, Centre for WTO Studies, pontificates, “Provisions governing grant of a CL under Sections 84 and 92 of the Patents Act, 1970 require any person to make an application for granting of CL after weighing commercial benefits from the license against a set of costs, including potential loss of opportunities of obtaining licenses from www.expresspharmaonline.com
research-based pharma companies. Both provisions require a willing person. It seems politically correct since direct use of patented products by the Government as provided u/s 100 of the Act may be a more aggressive approach which the GoI does not appear keen to adopt immediately. However, some legal experts also feel that CL might not be able to solve issues of access. “CL cannot solve India’s larger problems regarding access to medicines and healthcare, and the fact that CL are lawful in some circumstances does not mean that they should be regarded as appropriate policy measures in all instances. Legitimate and imminent health emergencies that require making exceptions to intellectual property rights can be accommodated under the international framework, but only after exhausting all other efforts and in extraordinary circumstances. CL is not the only way to access affordable cancer drugs. There are other options Government should consider to ensure we foster an environment that brings new medicines for Indian patients,” exhorts Krishna Sarma, Managing Partner Corporate Law Group. Elucidating some of these options which include invoking the provision of 'dominant position' in the Competition Act, Saha says one could argue that anticompetitive or unfair trade practices are being followed by companies, thus not making the drugs available to people at reasonable price. The government could also negotiate with these companies on the prices of the drugs. The patients can be supplied drugs at lower and affordable prices but the difference in this price and the negotiated price may be borne by the Government, he adds. Reji K Joseph, Assistant Professor, Centre for Studies in International Politics and Governance, Central University of Gujarat, builds up India’s case further by stating that there is a direct link between catastrophic health spending and poverty. With medicines forming a major chunk of it, India is well within its rights, given the mandate of Doha Declaration on TRIPS and Public Health and provisions in the Patents Act, to issue CL on grounds to protect public health, he states. Finally TC James urges inno-
RAGHAVA SAHA Past Head, Patent Facilitating Centre, TIFAC, GoI
A reasonable gestation period is needed for converting the patent(s) into marketable drugs which are duly approved by DCGI. Additionally, it has to be ensured that the desired production levels will be achieved vator companies to introspect. “Instead of crying foul too loud, patent owners should take a re-look at their strategies, including domestic manufacturing and technology transfer, which were flagged as the benefits that the Agreement on Trade Related Aspects of Intellectual Property Rights of 1994 for developing countries. A law can survive only if it meets the national aspirations and requirement and patent law is no exception to that.” Meanwhile the world is watching. In its Special 301 Report last year, soon after India issued its first CL, the United States Trade Representative to the US Congress stated, “As affirmed in the Doha Declaration on TRIPS and Public Health, the United States respects a trading partner’s right to protect public health and, in particular, to promote access to medicines for all, and supports the vital role of the patent system in promoting the development and creation of new and innovative lifesaving medicines” However, it remains to be seen what the stance will be when the report is released in April this year. shalini.g@expressindia.com February 16-28, 2013
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‘Time for a visionary budget’
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RANJIT SHAHANI, President, Novartis Group and President Organization of Pharmaceutical Producers of India and Country
014 will be an election year where the people will decide who will be the government at the centre for the next five years. The time is also ripe for the UPA government to give to the people of India a visionary budget that will be a harbinger of change. Education and healthcare will need to be high on the agenda of the present UPA government as both sectors need a boost in budget 2013. Infrastructure in both these sectors needs to be strengthened by way of tax incentives that will serve to encourage investments in these areas. Rural and semi-urban areas in India lack basic healthcare infrastructure. A weighted deduction for investment and expenditure incurred in these areas should be provided. Accordingly healthcare infrastructure status together with hiking the allocation to
healthcare will go a long way in improving the economic and health indicators of our country. These together with creative policies will serve to deliver top quality healthcare. India needs to foster an ecosystem that will not only encourage R&D but will also allow it to flourish. A way to do this would be to introduce research tax credits which can be used to offset future tax liability along the lines of existing systems in developed economies. Another would be to recognise the lengthy, risky
The time is also ripe for the UPA government to give to the people of India a visionary budge
and expensive processes involved in drug discovery by according benefits to units engaged in R&D and all income generated from the utilisation of Intellectual Property should be exempt from tax. Contract manufacturing which is a growth driver for the pharmaceutical industry should receive tax benefits by way of profitlinked incentives. All life-saving drugs, including medical devices, that are imported should be exempted from payment of customs duty. Diagnostic equipment and its consumables required to detect lifethreatening illnesses should be exempt from payment of both customs and central excise duties. Customs duty for formulations needs to be rationalised in line with the recommendations made by the Chelliah Committee. Reduction in duties on health supplements would
make these products more affordable to the common man and serve as a boost to the healthcare agenda of the government. Clinical trials need to be given priority status with all expenditure pertaining to such trials at approved hospitals being eligible for weighted deduction. The additional customs duty on import of vaccines, special medicaments and health supplements imported into India should be at a lower rate of two per cent. Health insurance by individuals needs to be encouraged and the quantum of deduction allowed to individual and senior citizens should be increased to also reflect rising costs. Budget 2013 presents the government and its Finance Minister an opportunity to come good with a visionary budget – a legacy that will be the forerunner to change.
‘Need more focus towards taxes’
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TAPAN J RAY, Director, General, Organisation of Pharmaceutical Producers of India (OPPI)
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iagnosis is an important aspect of the healthcare, which helps in detection, prevention and cure of disease. All life saving drugs (including medical devices) should be exempted from customs duty on import into India. Diagnostic equipment and consumables thereof specifically required for detecting life threatening diseases should be exempted from the levy of customs/central excise duty. At present the Basic Customs Duty (BCD) on formulations is 10 per cent (other than specified drugs, life saving drugs, vaccines and bulk drugs for which the BCD rate is five per cent). In BCD it should be reduced to five per cent for Formulations. Additional Customs Duty (ACD) and should be charged at a lower rate of two per cent on import of vaccines, specified medicaments and health supplements imported into India. Import of pharma Grade Un-denatured Ethanol used in manufacture of anticancer formulations should enjoy exemption/reduced customs duty. To ensure
proper end use, importers/manufacturers may be asked to submit an ‘end use certificate’ duly certified by a chartered accountant demonstrating the use of the said imported product in manufacture of anti-cancer formulations. There should also be clarity on the classification of the said product and the same should be classified under Chapter 29 of the Customs Tariff Act. The central excise duty rate of API (primary raw material for pharma formulation manufacturers) may be ratio-
Government should introduce a refund mechanism to enable pharma manufacturers to avail refund of excess Cenvat Credit especially in case of such an inverted duty structure
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nalised and made at par with pharma goods i.e. excise duty on the inputs (API) may be reduced from 12 per cent to six per cent. Alternatively, government should introduce a refund mechanism to enable pharma manufacturers to avail refund of excess Cenvat Credit especially in case of such an inverted duty structure.
Excise duty on pharma goods An abatement of 45 per cent to 50 per cent is necessary to enable pharma industry to cover its costs while calculating the central excise duty payable on finished goods manufactured in India. This abatement should be increased to 45 per cent to 50 per cent as the current 35 per cent abatement does not even cover the trade margins and the value of R&D costs and other costs associated with the pharma industry such as distribution of many medicines through “cold chain” – (e.g. vaccines). There are increased expenses that need to be incurred by the pharma companies. Even otherwise, the increase in the excise duty in
Finance Bill 2012 would need to be factored and accordingly department should consider an increase in the abatement percentage for pharma goods.
Cenvat credit The provision applicable prior to March 1, 2011 should be restored stating that Cenvat Credit is required to be paid only if value of goods is written off fully or provision for write off fully has been made in the books and not in case of write off or provision in the books for a partial amount. In the Finance Act, 2010, the Government allowed the manufacturers from the SSI industry to avail 100 per cent of the credit on capital goods in the first year of receipt of capital goods. Accordingly, in line of this, the Cenvat Credit Rules, 2004 (‘Credit Rules’) should be amended to provide for availing complete credit in the year of receipt of capital goods, subject to conditions. It is suggested that Credit Rules may be amended to recognise endorsed Bill of Entry as a valid document for availing credit of duty paid at the time of import. The erstFebruary 16-28, 2013
M|A|N|A|G|E|M|E|N|T while procedure of endorsement of Bill of Entry in such cases should be continued. The Central Excise legislation allows for registration of the importer under Central Excise so as to enable them to issue importers invoice as valid document for passing on Cenvat Credit of duty (ACD plus SACD) paid on imported goods. However, the present application format for registration (Form A1) under Central Excise (even under ACES registration) does not provide for registration for category of ‘importer’ which leads to procedural hassles and delay in getting registration.
Increase in MRP
Value added tax
In case of pharma goods where duty is paid on MRP value less abatement, there should not be any additional duty liability for undertaking labelling or packing activity without any increase in MRP of the said product. Alternatively, clarification to the said effect be issued by the department which specifically provides that mere change in labelling (to comply with regulatory requirements under other laws) or product packaging to meet business requirements should not be construed as ‘manufacture’, unless there is an increase in MRP.
The tax rate of four to five per cent on medicines and the list of tax-exempt goods and declared goods should be uniform across all states. Further, states have adopted varied description in their schedule entries in relation to drugs and medicines. Specifically, life saving drugs and life saving medical equipment should be included in exempt goods or zero rates of percent VAT category.
Service tax Provisions to be made to enable the brand owner to avail the credit in such cases and distribute the credit to
the job worker or avail the said credit on its own to do away with this inequitable situation differentiating between manufacture inhouse or at the job workers premises.
Export-oriented units Presently, we understand that all the SEZ units enjoy exemption from aforesaid import procedure by drug importer. There prevails an ambiguity with regard to extension of said benefit to EOU units. A suitable clarification in this regard would have to be issued to provide a mechanism for import of drugs by EOU units.
‘How will the govt procure medicines worth ` 27 cr?’
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AJAY KUMAR SHARMA, Pharmaceutical and Lifesciences Practice, Head Frost & Sullivan
he pharma industry is looking for clarity on pricing mechanism. It would help to keep excise duty minimum. The current transfer pricing mechanism is subject to internal taxes, there needs to be a clarity on how the government plans to make it more transparent. There also has to be an increase in R&D spend as a part of the GDP, more on
Ricing mechanism is subject to internal taxes, there needs to be a clarity on how the government plans to make it more transparent
NIPER like institutes. Most of the biotech clusters today are being driven by PE players, there should be a specific amount earmarked in the budget for cluster formation. GoI should also increase the ambit of life saving drugs and extend a custom duty on them. Introduction of a uniform or flat tax code is also required along with an increase in hospital spending. It needs
to be seen as to how will the government procure medicines worth `27 crores, would price be the only consideration, how does it plan to do drug testing, these are some questions that need to be answered. Also an increase in expenditure on exports and incentives for the same would help boost Indian exports to the US and help branding of Indian generics abroad.
‘The proposal to set up a NLSRC by the DBT is a welcome suggestion’
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PM MURALI, President, ABLE February 16-28, 2013
ABLE is pleased to note that the emphasis on developing the S&T skills of the India are being taken seriously and that the proposed 12th Plan outlay for DST, DBT and DSIR is expected to increase by 150 per cent to approximately ` 52,000 crores from the ` 20,500 crores spent in the 11th plan. Most of the initiatives of the three departments are well thought off and if all goes as per that it will certainly lead to a significant improvement in the Innovation index of India. In the last plan approximately ` 6000 crores of the total outlay of ` 26400 crores has been shown as unutilised and ABLE hopes that the current plan the entire sum of ` 52,000 crores is utilised. For planning it is very important that the parameters used for judging progress are clearly
defined, understood and grounded in reality. To establish a Performance Observation System in Science is a commendable approach. The proposal to set up a NLSRC by the DBT is a welcome suggestion since such a centre would help speed up the process of Innovation in SMEs. India has a large and vibrant industry that has a lot of good and trained scientists that have their ears and eyes plugged into the business realities of the var-
GOI takes it seriously since biologics is a national imperative and ABLE feels that it needs to be on the fast track
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ious industries they work in. In a situation where the GoI would like to increase the GDP spent on R&D from one to two per cent with one per cent contribution from the private sector, the private sector would also need parity to access R&D funds if the equation would have to strike a balance. In the past a lot of research happening in the public sector institutes was found to more academic. Efforts of the public sector need to focus on basic sciences and the efforts of the private sector need to focus on adapting and taking it to the market. Thus some mechanism needs to be worked out where duplication of effort or wasting resources on doing activities best done by other organisations needs to be avoided. For the human resources development or the Innovation/Incubation centres it would be perhaps
worthwhile to consider one body across the three departments instead of spending resources in parallel efforts. The National Government of several countries have stepped on their efforts in supporting their private sectors and have leapt ahead. China, Malaysia, Singapore and Korea are on an overdrive to capture the obvious near to mid-term opportunities. Sensing a better local support several Indian companies have set up or are planning facilities in such countries. To draw the attention to this situation ABLE has submitted a set of recommendations and hopes that the Government of India takes it seriously since biologics is a national imperative and ABLE feels that it needs to be on the fast track and be treated as a national mission spearheaded by the PMO because of the enormity of the task. EXPRESS PHARMA
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‘Aim to incentivise higher spending in R&D’
T RAJESH V DESAI, Executive Director and CFO, Glenmark.
he economic and political developments in the Eurozone area and the US have affected the world economy including India. Although the Indian economy is showing signs of improvement with growth of exports; surging inflation and high interest rates are still areas of concern. If the interest rate environment and inflation do not improve, industrial growth will continue to be under pressure. The priorities for the next Budget is to therefore provide growth impulse, especially in the manufacturing sector, keep an anti-inflationary stance, reduce the fiscal deficit and revive investment spending. A move which will be a
big boost to the Indian industry, including the pharma sector is reduction in excise duty and service tax. Excise duty and service tax rates, which are currently at 12 per cent, should be restored to the earlier level of eight per cent pre-
The Government needs to encourage the sector to promote higher spending in research and development through various incentives in the budget
vailing two years back. Reduction in these rates would help in augmenting the industrial growth, which has significantly fallen due to low capital investment and high inflation. For the pharma industry, which is already reeling under price controls and intense competition; a reduction in excise duty and service tax will come as a welcome measure. Talking from a pharma industry perspective, the budget should aim to incentivise higher spending in research and development. Union Budget 2012-13, did precious little for the pharma industry in terms of R&D sops to encourage innovation. The notable exception was the proposal to extend the 200 per
cent weighted deduction for R&D expenditure in in-house facilities for a further period of five years. The Government needs to encourage the sector to promote higher spending in research and development through various incentives in the budget. Hence, it is necessary to exempt import of all capital goods, raw material and consumable to be used for R&D purposes from custom duty, besides making Cenvat Credit available on capital goods used for R&D to reduce research cost. Bringing down taxes and duties on life saving drugs and active pharmaceutical ingredients (API) would further provide an impetus to growth.
‘Custom duty should be minimised, preferably eliminated’
F UMESH PAWA, Managing Director, ABSCIEX India
or drug discovery and development, the scientists in pharma world need access to innovative tools like the latest analytical instruments for which there are no local manufacturers. These are expensive tools and the cost is further escalated by application of customs duty as there is no alternative to these tools available locally. To make the access easier and assist in research and development of the pharma products which can eventually help the country in improving quality of health care, we suggest the following: Currently the product attracts more than 17 per cent customs duty when imported.
Since there is no local product available, this duty should be minimised, preferably eliminated. There are many new tools launched globally frequently with enhanced performance and features which can expe-
There is no way currently. The government should allow such temporary imports without any duty implications for a maximum tenure of six months
dite the drug development process as well as improve the quality of the pharma products. If some Indian company wants to try these products before actually purchasing them to establish the utility, there is no way currently. The government should allow such temporary imports without any duty implications for a maximum tenure of six months. If the product is accepted by the end users, the purchase can be regularised and applicable customs duty would be paid by the users. If the product is not accepted, it should be sent back to the manufacturer within the stipulated time frame. This will allow the Indian scientists to evaluate the product before
making the final decision and help our country to buy only what is useful to us. We should also encourage public private partnership for training and develop talent pool in India which is trained and with expertise to use these advanced tools. This will help not just the pharma community, but also other research institutes in various fields such as food / environmental and proteomics. While the private industry can provide access to the students to these latest tools, this is a huge investment for which the private industry should be incentivised.
‘A special focus on R&D funding is required’
I PAWAN CHAUDHARY, Chairman and Managing Director, Venus Remedies
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t is critical for the country to improve its macro economic conditions in order to have a healthy industrial growth in near term. This means immediate steps are expected to curtail the twin deficits, supply side of inflation and improvement of investment climate. We expect overall government focus on health care to improve and would welcome policies incentivising healthcare infrastructure in the country. Budget should give suitable directions to lift confusions over foreign direct
investments, national drug pricing policies and essential drugs procurement mechanism. In the past decade or
Budget should give suitable directions to lift confusions over FDIs, national drug pricing policies and essential drugs
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so, exports has contributed a lot into India’s growth story and to this cause export linked deductions have helped. It will be a good idea to reinvigorate deductions like section 80HHC. In the previous budget, time window for weighted average deduction was enhanced by another five years. However, the weighted average deduction excludes costs incurred outside the approved R&D facility. This leaves a significant costs of the pharma companies outside the scope of the deduction. Thus, clinical trials and
regulatory costs undertaken outside approved R&D facility or overseas should be covered. Besides, it will be a good idea to exempt R&D income from the tax net. A special focus on R&D funding is also required. On excise front, abatement of 35 per cent is too low given the fact that pharma industry has to shell out heavy costs in distributing and marketing through channel partners. The inverted duty structure between API and formulations is also a long pending demand of the sector. February 16-28, 2013
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‘Encourage R&D activity on clinical research front’
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ith a vision to establish India as a global centre for high quality, ethical contract research, ACRO India is continuously investing resources to set higher levels of a benchmark for systems, ethical standards, to be followed by CRO’s in India. To encourage the R&D activity on the clinical research front, we propose the following changes in Budget 2013-2014:
Service tax APURVA SHAH, Chairman, Association of Contract Research Organizations, (ACRO)
There is some clarity required with regards to the service tax applicability and by simplifying the law we can
boost research. The benefits derived by doing so will compensate for the loss of revenue in the long run in the following manner: 1. Reduce the R&D cost and therefore make the Indian pharmaceutical companies more competitive in the glob-
The language of Notification No.12/2012-under Service Tax Act should be amended
al market and reduce the cost of drugs in India 2. It will make R&D service offered by CROs more competitive and therefore grow this important industry. This will create more job opportunities and get us closer to develop new drugs locally at a very competitive cost. 3. The forex earnings will increase for both pharmaceutical companies and CROs. The language of Notification No.12/2012under Service Tax Act should be amended as: Considering the R&D activity is very capital intensive due to the investments required in investments in
new technology and training of man power the capital that’s saved on account of exemption in IT can be used for productive purpose and that will result in overall growth and competitiveness of the local CROs. This shall boost the research activities in India and can make India a global research hub by becoming more competitive among the other Asian countries. Both the above amendments shall also increase the employment in the country by way of development of existing and new units and will also increase export business which shall increase foreign exchange earnings.
‘GST on drugs must not result in higher tax’
T DAARA B PATEL, Secretary-General, IDMA
he Government might finalise implementation date of GST and we expect the total tax rate for pharma industry to increase. To ensure continued availability of medicines, GST on drugs and pharmaceuticals must not result in higher tax incidence compared to existing rate. Pharma manufacturers are required to keep aside a few boxes of each batch of medicine manufactured till its expiry as ‘control samples’ as per the provisions of the Drug & Cosmetic Act & Rules. These cannot be sold and as such should be fully exempted from Central
Excise Duty. Similarly, some samples of their medicines are provided to the medical doctors as ‘Physician’s samples’ to gauge their efficacy. These must be kept out of purview of all duties and taxes. The Indian pharma industry has always responded to the urgent calls of our
We expect that suitable incentives and concessions will be provided to keep our growth momentum
Government, both in Centre and in States, in times of disaster and natural calamities by providing free medicines anywhere in India, without minding the production costs and expenses involved in reaching the medicines to those affected victims. It is sad that despite our repeated requests and representations, the Government continues to tax these voluntary free medicines by imposing excise duty and sales tax on them! Considering the noble gesture by pharma companies, Exemption Notification should be granted suo moto, in regard to medicines supplied free of cost during national calamities and
where, Central Excise Duty has been paid in such cases, refund of duties should be promptly granted. Non profit organisations operating on a mutuality basis and regulated by applicable statutes (in particular bodies like Trade Associations and Co-operatives) need to be kept out of the purview of service tax. The last few budget presentations have almost overlooked the pharma industry, whose capability in providing affordable quality medicines is recognised globally. This year we expect that suitable incentives and concessions will be provided to keep our growth momentum.
‘We need to sustain significant growth process’
T SUJAY SHETTY, Leader Pharma and Life Sciences, PwC India February 16-28, 2013
he last year has been a good year both on the domestic and foreign markets front and there is optimism that the industry will continue to be on the growth path to be in the top 10 global markets by value, by 2020. In 2013 we are hoping to see more alliances and partnerships in the industry. Indian companies will gear up their activities to capitalise the growing potential of foreign generics market what we need to do now is to sustain the significant growth process which was initiated during the last year. Some of the issues which we would like addressed include the follow-
ing: Traditionally in the pharma industry, the excise duty rate on inputs has always been higher than the excise duty rate applicable to the finished products. Weighted deduction should cover activities like outsourced clinical
We need to do now is to sustain the significant growth process which “was initiated during the last year
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trials and R&D, preparations of dossiers, foreign consulting/legal fees for new chemicals entities (NCE) and abbreviated new drug applications (ANDA) filings with the US FDA. Patent defending charges. This would facilitate the companies to outsource part of research activity for achieving cost efficiencies. Further, exemption of 100 per cent profits of companies engaged in scientific research
and development for a period of 10 consecutive assessment years should be extended for the companies obtaining approval till March 2013. The 100 per cent tax-free status for biotechnology and pharma SEZs should be increased from the present five to 10 years. Anti cancer drugs should be treated as life saving drugs and it is imperative that they are exempt of all taxes and duties.
Like each year this year too the industry is expecting a lot from the upcoming Union Budget 2013-14 but whether it will rise upto their expectations or not is something that will be revealed only after Finance Minister P Chidambaram reveals the budget. u.sharma@expressindia.com shalini.g@expressindia.com
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LEGAL EAGLE To poll or not to poll Milind Sathe, Deputy General Manager-Projects, Unichem Laboratories, submits a qualitative analysis of responses to a recently posed opinion poll asking if the Patent Act of India encourages innovation and tries to understand the type of conclusions that can be drawn from the responses and judge the validity of possible conclusions pinion polls in the areas of technology, its perception or any national enactment have far reaching impact not only on the policies for internal administration but also on image of the nation on international platforms. Questions in opinion polls sometimes cover a broad spectrum of issues and logically it is not possible to opt a categorical option or choice such as “yes” or “no”. Normally the choices or options given are Yes/No/Can’t Say. Response to opinion polls as “yes” or “no” in such cases, leads to wrong conclusions and unrealistic results. There are two main reasons. One is associated with the question and the qualitative aspects covered by question. When a question is associated with plurality of issues and a dynamic situation, it cannot be answered in totality by expressing opinion over some limited aspects covered by the question. Number of perspectives covered by the question or the depth of each aspect is so diverse that it is practically impossible to respond conclusively and completely for realistic satisfaction of the query. It means the question should relate to a singular aspect if realistic conclusions are to be drawn from responses to the question. Second aspect relates to the extent of knowledge that the responder has about the subject matter of the question, his abilities to interpret the question and correlate it to aspect/s covered by question. Ability of the responder to envision the spectrum covered by question, his insight into all aspects will
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govern the type of response and thereby the conclusions drawn from such opinion polls. It directly questions the reliability and validity of conclusions. It is impossible for anybody to address the diverse aspects and the entire spectrum covered by the question and to form a singular response in terms of Yes or No that is true and valid for all aspects. The above two aspects, one which relates to the type of questions and second to the responder jeopardises and frustrates the basic motive of putting the question. Therefore use of such opinion polls and reference to the conclusions drawn, can mislead the public at large. If it is used in any litigation it may impress the judge in a prejudicial manner. It can create a lot of difficulties in arriving at the truth. It will lead to wastage of taxpayer’s money besides creating difficult situations for the society. The nation may lose maiden opportunity to establish a useful worthy precedent. Let us analyse the possibility of responding to an opinion poll which questioned the ability of the Indian Patent enactment, try to understand the type of conclusions that can be drawn from the responses and judge the validity of possible conclusions. Situation pre TRIPs is marked by absence of product patent which enables establishment of potent and contributing pharma sector that not only helped India but the world at large for supply of affordable medicines. Post TRIPs, The Patents Act was amended several times to align it to TRIPs and it was done to conform to the deadline of 2005. The said alignment was done systematically with extreme professionalism, worth imitating it by any least developed country which is supposed to align itself to TRIPs in the next four years. A quick summary of the process of this alignment is as follows: 1)First amendment www.expresspharmaonline.com
(1999): Exclusive Marketing Rights (EMRs) for post 1995 inventions. It created a facility of temporary monopoly of five years till mail box applications could be processed. 2)Second amendment (2002): The Patents Act 1970 was made TRIPS compatible. 3)Third amendment 2005: a. Full TRIPS compatbility; b. Internalisation of Doha Declaration; c. The Product Patent Regime came into force from 1.1.2005; d. Section 3 (d) denies patentability to minor improvements; e. Asserted governmental powers in health emergencies; f. Facilitated export of urgently needed drugs to countries which did not have the capability of producing them With all these amendments, Indian Patent enactment is at par with any patent enactment anywhere in the world. One should always remember that few nations are intelligent enough to design other legal rules and enactments which impact patents and enforcement of patents. They have kept provisions out of patent enactment but these provisions severely impact the ability of the patentee to enforce the patent. These provisions are often present in laws governing competition and other premier documents such as constitution of the country. Laws governing competition provide for forcible dilution of the patent monopolies in order to achieve objectives of competition laws. Some of such provisions produce the same effect as is produced by compulsory licensing provisions in patent enactment. Constitutional provisions in some countries provide for total neutralisation of patents and allow the State to use the patents without approaching the patentee for permission to use. These provisions are far more severe than compulsory licening (CL) provisions in Indian patent enactment. These nations have used
these acidic provisions several times for several issues. On the other hand, the record of use of CL in India is absolutely negligible. Record of use of provisions in Indian patent enactment related to forcible dilution of patent right are almost nil as compared to the use of similar provisions abroad. With this input let us try to interpret the responses to this poll query: Q) Do you think that the Indian patent law nurtures and promotes innovation? Response “Yes” It means The Patents Act of India encourages invention to the same extent to which any other Patent enactment that is conformity with TRIPs would encourage. This response presumes that respondent has understood harmony of Indian enactment with TRIPs and is well aware of TRIPs, flexibilities provided by it. It also indicates that respondent supports sovereign actions which are in conformity with law of the land. It also means that respondent acknowledges appropriateness and utility of the TRIPs compliant patent enactment with the national scene which is marked by inherent differences in structure of the economy, industry, consumption patterns and demographic needs of the nation as compared with the developed world. It also means that the respondent supports sovereign expression as is supported by laws February 16-28, 2013
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Response “No” It is interesting to analyse this response. If we presume that the response is due to some repugnant provisions in the Indian enactment, then which can be these provisions? When the law is in conformity with TRIPs, it doesn’t have provision that contradicts it. Had that been the case, we would have been isolated way back. It did not happen. Although reports like 301 blame India for poor IPR structure, it is common sense to understand the selfish motive behind such blame game. If we consider FDI to be indicator of required quality and level of patent enactment then our law has that inherent quality. Had there been a real fault in IPR frame in India, India would not have been favourite destination for significant flow of FDIs. There are many nations which have succumbed to international pressures, formulated obnoxious patent provisions contradicting national priorities and yet have failed to attract FDIs. Still if the response is “No”, and if the responder is aware of the FDI flows, then what can be the motive for the negative response? Is the negative response a careless response? Is it a white collared style to blame anything that is of Indian origin? If that is the reason, it should be done away with immediately. It creates wrong impression more about the responder than about India and its enactment. If it is due to presence of CL provisions in Indian enactment, then responder needs to know more about prevailing provisions in other nations. 28USC1498 provides for use of patents by State without the permission of patentee. Indian CL provisions require a prior effort by CL applicant for licensing. Section 66 of Indian enactment is not the same as 28USC1498. Section 66 is more predictable and clearer than 28USC1498. CL provisions of Indian enactment are also predictable and clear. Above all these are TRIPs compliant. In spite of this if the response is “No”, should one conclude that responder wants to have an enactment that is incapable of taking care of India, its needs and public interest? Should one conclude that responder wants to have legal provisions that contradict TRIPs? Should one conclude that “NO” is a motivated response engineered to defame India and its laws?
transparent response. May be the responder has some doubt but not sure about interpretation of some sections or is not sure if they conform to TRIPs or may be he is not able to extrapolate the impact of some provisions on innovation. May be he is aware that though constitution of some nations refer grant of exclusive rights to authors and inventors for limited times to promote the progress of science and useful arts, he is also aware of use of an invention described in and covered by a patent by the State without license of the owner or without the lawful right to use or manufacture the same. At the same time he is confused by loud lopsided propagation by alleged IPR experts and IPR professionals criticising Indian enactment. Presence of more restrictive provisions in laws of developed world and their frequent use by them that constricts patentee might have confused responder and he is not able to decide why Indian patent enactment should be blamed at all. But then why few people, some of them Indian by birth say so? So possibly the response “Can’t say” indicates the open mind and scope to understand the utility, appropriateness of Indian enactment. Can this be said about the response “No”? Let the readers decide it. Possibly in knowledge economy while opining on any national enactment, it is necessary to verify if national enactment conforms to any international agreement to which the nation is signatory and if the national enactment has fully exploited the flexibilities provided under the said agreement. If the flexibilities are exploited fully, then the national enactment is good. If flexibilities are not exploited then national enactment is bad as non use of flexibilities is detrimental to free and fearless sovereign expression on international platforms. It amounts either to inadequate understanding of the international agreement or a great scope for better leadership at the apex level in the nation concerned. Globalisation should be interpreted not as a freeway for foreign entities to invade domestic markets and rupture national economy but a means to strengthen national economy by successfully retaining control over domestic markets and expanding into foreign markets by fully exploiting the international agreements. Any national enactment that ensures these objectives can never be labelled as “not nurturing and not promoting innovation. !!!!
Response “Can’t say” It seems to be the genuine and
Views expressed in this article are personal
of developed world. Most important is the intellectual approval to CL provisions.
February 16-28, 2013
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RESEARCH EXPERTISE FOR DRUG DEVELOPMENT
INSIGHT Quantum dots as nanoshells Dr Pradnya Palekar Shanbhag, Associate Professor in Pharmaceutics, Department of Pharmaceutics, Vivekanand Education Society’s College of Pharmacy expounds on Quantum Dots, nanotechnology and their applications in medical science uantum dots (QDs) are tiny semiconductor nanocrystals with a quantum confinement property that enables them to emit fluorescence from visible to infrared wavelengths on excitation. The size of QDs ranges within the nanometre scale, normally 2-10 nm in diameter. Typically, a single QD contains a total of approximately 100-1, 00,000 atoms in its crystal core. Recent advances in nanomaterial have produced a new class of fluorescent labels by conjugating semiconductor quantum dots with biomolecules. These nanometre-sized conjugates are water-soluble and biocompatible, and provide important advantages over organic dyes. In particular, the emission wavelength of quantum-dot nanocrystals can be continuously tuned by changing the particle size, and a single light source can be used for simultaneous excita-
Q
tion of all different-sized dots. High-quality dots are also highly stable against photo bleaching and have narrow and symmetric emission spectra. These novel optical properties render quantum dots ideal fluorophores for multicolour, imaging therapy, tumour detection, tissue imaging, immunohistochemistry, infectious agent detection and multiplexed diagnostics in nanomedicine.
depends on the size of the band gap which can be altered by changing the size of the QD as well as changing the surface chemistry. It is important to note that the smaller the QD the higher the band gap energy. This size tunable absorption and emission property of QDs is an extremely valuable property for biological imaging as they can be tuned all the way from the UV to the NIR of the spectrum.
Mechanism of fluorescence
Biocompatibility
In the bulk form of the semiconductor material the electrons exist in a range of energy levels described as continuous. At the nanoscale, these levels become discrete owing to the effects of quantum confinement. Following a stimulus, the electron jumps from the valence to the conduction band across the band gap leaving behind a positively charged hole. After being excited to the conduction band, the valence electron drops back to its valence position emitting electromagnetic radiation which is different from the original stimulus. This emission frequency is perceived as fluorescence and
In order to utilise QDs in a biological environment they need to be made hydrophilic. The main strategies to make QDs biocompatible include salinisation and surface exchange with bi-functional molecules. Also by method of encapsulation of QDs within phospholipids micelles, polymer beads or shells, amphiphilic polysaccharides or block– copolymer micelles, which are composed of synthetic polymers containing hydrophilic and hydrophobic parts. Mercaptohydrocarbonic acids such as mercaptoacetic acid can be used for coating QDs to make them biocompatible presents the advantages and limitations of the main methods for making QDs biocompatible.
Quantum dots as carriers with integrate functionalities The size of QDs can be continuously tuned from 2 – 10 nm which, after polymer encapsulation, generally increases to 5 – 20 nm in diameter. Particles smaller than 5 nm are quickly cleared by renal filtration whereas bigger particles are more likely to be uptake, by the reticuloendothelial system before reaching the targeted disease sites. Additionally, larger particles have limited penetration depth into solid tissues. Hydrophilic therapeutic agents (including small interfering RNA [siRNA] and antisense oligodeoxynucleotide [ODN]) and targeting biomolecules (such as antibod-
PHARMA ALLY 63 PHARMA LIFE 72 Structure of a quantum dot
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R|E|S|E|A|R|C|H ies, peptides and aptamers) in turn can be immobilised onto the hydrophilic side of the amphiphilic polymer via either covalent or non-covalent bonds. This fully integrated nanostructure may behave like a magic bullet that will identify, bind to and treat diseased cells and emit detectable signals for real time monitoring of its trajectory.
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gated to several biomolecules where a QD can hold up to ten 150-kDa proteins which would seriously hinder both the mobility of QDs and the functionality of the conjugated protein molecules unless its valency is reduced QDs may also be subject to reduced luminescence activity due to their relatively large surface areas
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The transport of a large volume (due to multiple attachments of drug molecules to a single QD) across the membrane will be more difficult than the single molecule Large scale use of QDs is their toxicity The fact that QDs have basic components that are highly toxic to humans e.g. Cadmium raises seri-
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ous safety issues For in vivo studies the main concern is the robustness of the surface coating. An unstable surface coating could expose the CdSe core of the QD to UV damage or air oxidation and result in release of cadmium ions from the QD core the ZnS capping would protect the core from air oxidation but not from UV damage
Commercialisation and regulatory issues The next challenge associated with QD-based medical applications is the commercialisation of the products and development of the appropriate regulations. Again toxicity issues are a major concern. Although research is going on and QDs for life sciences research applications are commercially available applica-
One additional feature of QDs is that they can emit in the infrared and near-infrared regions. This makes them suitable for imaging and diagnostic applications in cells deep within tissues as the absorption of tissues is minimal in this region QDs whose composition includes hybrids of heavier metals e.g. CdTe or HgSe or PbSe are being considered for such applications due the extension of their emission spectra into the near-infrared region. Also the stability of QDs and their resistance to metabolic degradation in live cells would allow long-term imaging studies and several studies have indicated lack of cytotoxicity for periods up to four months. ● In vitro nanodiagnostics immunohistochemistry ● A QD-based assay for the detection of the ovarian cancer ● QDs survive typical tissuemounting procedures ● Immunoassays ● Nucleic acid detection ● Detection of genetic polymorphisms ● Single-molecule detection ● Stem cell tracking ● Neurotransmitter detection ● Imaging ● Diagnostic imaging ● Proteomic and genomic applications ● Drug delivery ● QDs are important for delivering drugs ● Photodynamic therapy ● Drug discovery
Quantum dots catch cancer early Using an ultraviolet light or laser light shines on a quantum dot. The dot quickly passes energy to nearby molecules that use the energy to emit a fluorescent glow. Cancer-related DNA strands lights up and identify them. Up to 60 of the targeted DNA strands stick themselves to a single quantum dot like arms extending from an octopus.
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Limitations ●
Ability of QDs to be conju-
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Cancer-related DNA strands stick to single quantum dot like arms extending from an Octopus
tions involving QDs for in vivo imaging, drug deliveries and therapy have a long way to go before they can hit the market. In general, drug development is an extremely rigorous and costly process with delivery times for preclinical, clinical studies and approval increasing from 11.6 years in the 1970s to 14.1 years in the 1990s. Nano-biotechnology market is rapidly expanding and several establishments including the National Institute Health (NIH) and the National Nanotechnology Initiative (NNI) are investing into nanomedicine in general and resolving QD toxicity issues for medical applications in particular. The NIH expects that over half of the biomedical advances by 2010 will be in the nanotechnology sector and by that time the projected market growth for molecular imaging is $45 billion.
Conclusion The potential applications of QDs in nanomedicine are numerous spanning the areas of imaging, therapy, drug delivery and nanodiagnostics. In the latter area the most promising applications are tumour detection, tissue imaging, intracellular imaging, immunohistochemistry, infectious agent detection, multiplexed diagnostics and fluoroimmunoassays. The National Heart Lung and Blood Institute Nanotechnology Working Group concluded that using QDs as tools for diagnostics and biosensor development is a promising domain and recommended its follow up. Despite all their promise QDs are still away from large scale use in nanomedicine pending the resolution of toxicity concerns and regulatory and commercialisation issues. The in vitro applications are likely to expand quickly in the coming few years as the technology is rapidly utilised and optimised to reach the sensitivity and overall needed clinical per-
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formance level and the toxicity issues are much less pressing than for in vivo application, which will probably take over a decade to be used commercially with confidence. It must also be emphasised that the concerns and issues associated with the QD technology must be investigated. This will ultimately enhance the chances of QDs coming into regular use in the medical practice and avoid running into roadblocks with their application later on. All in all, the potential of QDs is immense and would shed a new light on various medical applications.
References [1] Weiss S. -Fluorescence spectroscopy for single biomolecules. Science 1999; 283:1676–83. [2] Jain KK. –Nanodiagnostics, application of nanotechnology in molecular diagnostics. Expert Rev Mol Diagn 2003; 3:153–61. [3] Salata O. - Applications of nanoparticles in biology and medicine. J Nanobiotech 2004; 2:3. [4] Fortina P, Kricka LJ, Surrey S, Grodzinski P. Nanobiotechnology: the promise and reality of new approaches to molecular recognition. Trends Biotechnol 2005;23:168–73. [5] Kim S, Lim YT, Soltesz EG, De Grand AM, Lee J, Nakayama A, et al. -Nearinfrared fluorescent type II quantum dots for sentinel lymph node mapping. Nat Biotechnol 2004; 22:93–7. [6]Bruchez M Jr, Moronne M, Gin P, Weiss S, Alivisatos AP. -Semiconductor nanocrystals as fluorescent biological labels. Science 1998; 281: 2013–6. [7] Murphy, C. J., Sau, T., Gole, A. and Orendorff, C., Surfactantdirected synthesis and optical properties of onedimensional plasmonic metallic nanostructures. MRS Bull., 2005, 30, 349–355. [8] Fortina P, Kricka LJ, www.expresspharmaonline.com
Surrey S, Grodzinski P. Nanobiotechnology: the promise and reality of new approaches to molecular recognition. Trends Biotechnol 2005; 23:168–73. [9] Michalet X, Pinaud FF, Bentolila LA, Tsay JM, Doose S, Li JJ, et al. -Quantum dots for live cells, in vivo imaging, and diagnostics. Science 2005; 307:538–44. [10] West JL, Halas NJEngineered nanomaterials for biophotonics applications: improving sensing, imaging, and therapeutics. Annu Rev Biomed Eng 2003; 5:285–92. [11] Liang RQ, Li W, Li Y, Tan CY, Li JX, Jin YX, et al. An oligonucleotide microarray for microRNA expression analysis based on labeling RNAwith quantum dot and nanogold probe. Nucleic Acids Res 2005; 33:e17 [12]Smith AM, Duan H, Mohs AM, Nie S. Bioconjugated quantum dots for in vivo molecular and cellular imaging. Adv Drug Deliv Rev 2008; 60: 1226–40. [13]Chan WC, Nie S. Quantum dot bioconjugates for ultrasensitive nonisotopic detection. Science 1998; 281: 2016–8. [14] Derfus AM, Chen AA, Bhatia SN, et al. Targeted quantum dot conjugates for siRNA delivery. Bioconjug Chem 2007; 18 (5): 1391 -6 [15] Jain KK. Nanotechnology in clinical laboratory diagnostics. Clin Chim Acta 2005; 358:37–54. [16] Härmä H, Soukka T, Lövgren T. Europium nanoparticles and time resolved fluorescence for ultrasensitive detection of prostate-specific antigen. Clin Chem 2001; 47:561–8. [17] McNamara JO, Andrechek ER, Wang Y, et al. Cell type-specific delivery of siRNAs with aptamer-siRNA chimeras. Nat Biotechnol 2006 ; 24 (8): 1005 -15 [23]Wang HZ, Wang HY, Liang RQ, Ruan KC. Detection of tumor marker CA125 in ovarian carcinoma using quantum dots. Acta Biochim Biophys Sin (Shanghai) 2004; 36:681–6. [18] Manabe N, Hoshino A, Liang YQ, et al. Quantum dot as a drug tracer in vivo. IEEE Trans Nanobiosci 2006 ; 5 (4): 263 -7 [19] Bruchez MP. -Turning all the lights on: quantum dots in cellular assays. Curr Opin Chem Biol 2005; 9:533–7. [20] Patolsky F, Gill R, Weizmann Y, Mokari U, Banin T, Willner I. Lighting-up the dynamics of telomerization and DNA replication by CdSe–ZnS quantum dots. J
Am Chem Soc 2003; 125:13918–9. [21] Yezhelyev MV, Gao X, Xing Y, Al-Hajj A, Nie S, O'Regan RM. Emerging use of nanoparticles in diagnosis and treatment of breast cancer. Lancet Oncol 2006; 7:657–67. [22] Baqalkot V, Zhang L, Levy-Nissenbaum E, et al. Quantum dot-aptamer conjugates for synchronous cancer imaging, therapy, and sensing of drug delivery based on bifluorescence resonance energy transfer. Nano Lett 2007 ; 7 (10): 3065 -70 [23]http://newscenter.cancer.gov/cancertopics/understandingcancer/nanodevices/a llpage [36] R. Raghavachari, Marcel Dekker, Near-Infrared Applications in Biotechnology, New York, 2001 [24] Gao X, Nie S. Quantum dot-encoded beads. Methods Mol Biol 2005; 303:61–71. [25] Larson DR, Zipfel WR, Williams RM, Clark SW, Bruchez MP, Wise FW, et al.Water-soluble quantum dots for multiphoton fluorescence imaging in vivo. Science 2003; 300:1434–6. [26] Waggoner A. Fluorescent labels for proteomics and genomics. Curr OpinChem Biol 2006; 10:62–6. [27] Emerich DF, Thanos CG. - The pinpoint promise of nanoparticle-based drug delivery and molecular diagnosis. Biomol Eng 2006; 23:171–84. [28]Bakalova R, Ohba H, Zhelev Z, Ishikawa M, Baba Y. Quantum dots as photosensitizers? Nat Biotechnol 2004; 22:1360–1. [29] Samia AC, Dayal S, Burda C. Quantum dot-based energy transfer: perspectives and potential for applications in photodynamic therapy. Photochem Photobiol 2006;82:617–25. [31] Han M, Gao X, Su JZ, Nie S. Quantumdot-tagged microbeads for multiplexed optical coding of biomolecules. Nat Biotechnol 2001; 19:631–5. [30]Ozkan M.-Quantum dots and other nanoparticles: what can they offer to drug discovery? Drug Discov Today 2004; 9:1065–71. [31] Jaiswal JK, Simon SM.- Potentials and pitfalls of fluorescent quantum dots for biological imaging. Trends Cell Biol 2004; 14:497–504. [32] Alivisatos AP, Gu W, Larabell C. -Quantum dots as cellular probes. Annu Rev Biomed Eng 2005;7:55–76. (With inputs from Sujata S Gaikwad, Manasi M Chogale, Sneha V Jog)
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INSIGHT
Quality in APIs Dr BV Sivakumar, Chief Scientific Officer,Enaltec Labs, provides an insight about the quality of synthetically manufactured generic Active Pharmaceutical Ingredients he so-called wonder drug, Thalidomide, of the era of 1960 and its consequences were the first stepping stones leading towards the need of understanding a medicine completely. The Thalidomide incident was the base to scrutinise the quality of new drug substances (Active Pharmaceutical Ingredi ents). It was the onset of conscientious drug approval procedures which paved the way for the publication of numerous guidelines and regulations on the quality of medicines worldwide. Especially the complete focus had turned towards the APIs. APIs is a broad term which encompasses both new drug substances and generic drug substances.
T
Definition of quality As per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), quality is defined as 'The degree to which a set of inherent properties of a product, system or process fulfils requirements.' Though the inherent properties of products define the quality, it is always monitored and controlled by a set of specifications with appropriate acceptance criterion. The specifications either exist through pharmacopoeia or can be developed in-house in accordance with process chemistry and within the requirements of ICH.
Defining an effective specification According to ICH, specification is defined as 'A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described.' The set of specifications of an API always include the February 16-28, 2013
W H AT ’ S INSIDE
inherent properties along with the requirements of its intended formulation. For example, based on the dosage and/or maximum daily dose, the specification for the related substances is established whilst the physical attributes like bulk density, particle size distribution of the API are set based on type of the formulation like oral solid dosage and/or liquids or based on the formulator requirement. The quality of an API consists of physico-chemical attributes, physical attributes, chemical attributes, and microbiological attributes. A proficient API specification is based on the sound evaluation of the process chemistry, however, a typical specification of an API embodies tests like description, solubility, tests for identification, loss on drying/water content, residue on ignition, heavy metals, related substances, assay, chiral purity (as applicable), residual solvents, bulk density, particle size distribution, and microbiological quality. These quality attributes are reciprocally connected with each other in one way or the other.
The reciprocal connection of quality attributes Description and solubility are inherent physical properties of API but these are not themselves standards or tests www.expresspharmaonline.com
for purity even though they may indirectly assist in the preliminary evaluation of the integrity of an article. However, description of a product has its significance when certain APIs are known to change the colour upon storage due to the inherent properties. It is mandatory that the description should be defined accordingly. Such kind of specification help formulators to define the formulation design and to understand the stable nature of the API. Like description, the drift/change in the trend of the specific solubility pattern and melting range upon storage alerts the manufacturers about polymorphic stability of the API as certain APIs exists in various polymorphic forms and exhibits specific solubility pattern and melting point according to its form. 'Tests for Identification' aims to provide confirmation of the identity of the substance in question. This can be achieved by complex instrumentation techniques such as spectrophotometric analysis which includes infra red and nuclear magnetic resonance spectra and chromatographic examinations which include liquid and/or gas chromatography which serve as primary identification. A specific morph of an API has a significant IR spectrum than its other polymorphs or mixture of polymorphs. Other methods of identification like determination of physical constants such as melting point, freezing point, boiling point, specific optical rotation, angle of rotation, ultraviolet spectrum, specific absorbance, relative density, refractive index and viscosity, as well as chemical reactions such as colour or precipitation reactions serves as secondary identification of the API. It is essential that the task of identification shall
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P|H|A|R|M|A| A|L|L|Y not to be confused with the assessment of its purity or the determination of its strength, although ultimately all three aspects are inter-related. Water content of an API reveals molecular composition such as hydrates. On the other hand, loss on drying just serves as a control and monitoring test and the values are mainly used in calculating the content of assay of the product. Residue on ignition and heavy metals are indicative of the inorganic impurities and residual heavy metals respectively. These tests deal with the control on physiologically dangerous and harmful impurities which very often creep into the final product through the handling or process. The conventional test for heavy metals indicates the presence and/or absence of 10 heavy metals like arsenic, antimony, bismuth, cadmium, copper, lead, mercury, molybdenum and tin in the API. Higher the content of these inorganic impurities not only affects the quality, it becomes a concern of safety too. Related substances are structurally related compounds to a drug substance which forms the critical quality attribute of APIs. These related substances may be identified or unidentified degradation products or impurities arising from a manufacturing process or during storage of a material. These impurities can be toxic, may affect the therapeutic activity of the product and is now receiving critical attention from regulatory authorities. Assay, a measurement of the concentration of the actual moiety is in direct relation with the safety, efficacy, strength and purity of an API and formulated dosage. Mass balance of assay and impurities should always be maintained or else should be justified. One of the major chemical attribute in synthetic API is the chiral property of the product which exists as racemic mixtures and selective isomers. The content and proportion of the unwanted isomers is always considered as contamination in the product which is categorised as API impurities and they impact on the bioavailability and therapeutic activity of the drug in the human body. Bulk density (BD) and particle size distribution (PSD) are not built-in properties of any API but it can change as to how the material is processed. The BD and the PSD are inter-
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related attributes. To establish a required BD, the PSD should be defined. BD and PSD are critical parameters in the oral solid dosage formulations as it invariably affects the compression of tablets, capsules and suspensions. Microbiological attributes also play a significant role and they are not inherent properties but arise during the processing of the product and is ensured by appropriate GMP systems. The total viable aerobic count (TVAC) and total yeast and molds count (TYMC), collectively known as bio-burden, of the API should be limited within the prescribed limits as in the pharmacopoeial chapters.
process as even a small drift in the temperature and solvent addition can lead to the formation of an unwanted isomer which finally impacts the quality. The biggest regulatory challenge for the API manufacturer is to establish compliance to various pharmacopoeial grades and maintaining a balance between the less regulated markets and regulatory markets through a single process or by a simply modified process as the specifications are often different in USP, BP/EP, JP and IP. Establishing a process which caters compliance to specifications of all market is the toughest quality job in an economically viable way.
Challenges in maintaining the quality of APIs
Quality by design
Isolation of selective polymorphs, Synthesis of desired isomers of therapeutic activity, and meeting the advance levels of regulatory compliance are the major challenges in maintaining the quality of APIs. The case study of Ritonavir launched in 1996 which resulted in unexpected dissolution pattern is the ideal example that demonstrates the importance of the understanding the concept of identifying the typical polymorphs to be manufactured, monitored and controlled appropriately in the process. Each polymorph has a degree of therapeutic activity and is critical for a formulation. Selective polymorphs are isolated by controlled crystallisation process and using specific solvents these are the most critical process parameters in a synthetic API process which requires hours of monitoring and meticulous understanding of the process dynamics. Only chiral products have isomers and it has got specific isomer/s which has the therapeutic activity. Based on the number of chiral centres in a molecule, the number of isomers exists. However, it is not necessary that all isomers are biologically active. Therefore, it is required to manufacture the desired isomer in a pure form or as a racemic mixture. This is a very crucial challenge for the API manufacturer as it changes the whole composition of the molecule and quality of the product. In a selective isomer synthesis process like optical resolution technique, there are chances of generation of a number of isomers. The synthesis of desired isomer is difficult to control during the manufacturing
Along with the control of the quality parameters in the API, it is important that the quality is built in the API by the process design. The selection of the route of synthesis and thus the selection of the key starting material (KSM) is a building block of the quality in the API. In designing a route of synthesis, the complete knowledge of the raw materials, reagents, solvents and catalysts that are to be applied in the manufacturing process needs to be thoroughly studied for their toxic, carcinogenic, mutagenic and genotoxic properties and ideally, they should be avoided. In case of unavoidable circumstances, the process should be designed to restrain them well below the prescribed levels. Experience from R&D, manufacturing and knowledge from scientific and technical publications should be reviewed and applied in designing the process to understand the Critical Quality Attributes (CQA) of the API and subsequently the Critical Process Parameters (CPP) which aims at the CQA. The negative experiments during the product development provides meaningful information on the process dynamics and throws light on the selection of specified equipment in terms of its material of construction (MOC), capacity, steerable volumes and other required accessories like distillation columns and their efficiencies, and an idea on selecting the application of basic manufacturing techniques such as crystallisation, isolation by fractional distillation for removing impurities, seeding for crystal formation, kinetic optical resolution and asymmetric synthesis for achieving
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chiral purity.
GMP to ensure consistent quality It is a prime responsibility of the management that the culture of implementation of cGMPs shall be brought. The management should emphasise on inculcating the GMP practices as a tradition and not the compulsion. Clear instructions and relevant actions with respect to the quality aspects influence the employees towards their roles and responsibilities in bringing and maintaining the quality of products.
Economically-viable-quality product The generic API industry countenancing three constant changes. One is the hike in the prices of the raw materials, second is the fall down of API prices and finally, the introduction of new stringent regulations. A process developed early, well optimised and successfully yielding with consistent quality cannot sustain even an year as these three changes occurs often in the API industry. The industry cannot do much for the situation immediately except being innovative on the process which holds a patent and/or focused on the continuous improvement on the process, out sourcing of starting materials/intermediates through appropriate commercial and quality agreements, continuous research on cost reduction, developing strong knowledge on the process chemistry, effective and practical production planning and inventory control, recycling of solvents, recovery of products from the mother liquor as per the regulations and their compliance to quality -could only make a product economically viable and shall become a sustained source of API in the market.
Conclusion Quality in API is the first requirement of an effective, safe finished dosage formulation. The manufacturing of API involves chemical reactions which are highly complex and every quality attribute is highly interrelated, it is a tricky living to establish, maintain and control the quality in APIs. Nevertheless, the quality of API decides the quality of formulation and formulations demands the requirements on the API. Thus, the quality of API is an integral part of the quality of the formulation or vice versa. February 16-28, 2013
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VENDOR NEWS Waters introduces peptide separations chromatography columns W New charged surface hybrid particles lead to greater loading, separation efficiency and enhanced information from
aters has launched a novel series of UltraPerformance LC (UPLC) and High Performance Liquid Chromatography (HPLC) columns for peptide mapping and proteomics as well as for the analysis and labscale purification of synthetic peptides. Waters ACQUITY
UPLC CSH130 C18 and XSelect HPLC CSH130 C18 Columns set a new standard in the analysis and purification of peptides and for the quality of information generated by UPLC, LC and LC-MS assays. Waters’ synthesis process is unique for its Charged Surface Hybrid (CSH) parti-
cles that imparts a low level positive charge to the surface of each particle. This CSH particle technology allows the columns to be used with a weaker acid modifier such as formic acid to deliver greater resolving power and improved method sensitivity – especially when compared to standard LC-MS methods
that use MS signal-suppressing ion pairing additives such as trifluoroacetic acid (TFA). In fact, in test after test, with formic acid the CSH130 C18 Columns produce significantly better peak efficiency than all other columns at all temperatures/flow rates. EP News Bureau- Mumbai
SCHOTT to host open Fiolax academy in Mumbai Will offer an intensive programme for pharmaceutical companies
CHOTT Glass India is holding the next Fiolax academy on April 26, 2013, in Mumbai. SCHOTT, through this event, will offer an intensive programme for pharmaceutical companies. Professionals from the production departments, quality management, R&D and primary packing development can expand their knowledge about glass as basic material for primary packing — and thus improve the quality and cost level of their own processes and products. This academy is named after SCHOTT Fiolax glass tubing, a leading material for use in manufacturing pharma packaging. The programme's objective is to share latest informa-
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tion on composition, properties and production of highquality pharma glass tubing. At this year’s event, global experts from SCHOTT Group will share their knowledge on crucial topics for anyone who works with pharma: drugcontainer interaction, hydrolytic resistance of glass containers, surface alkalinity and pH shift, extractables/ leachables, protein adsorption and light protection. Special knowledge will be provided about the impact of glass on the filling processes, e.g. in avoiding breakage risks. Sundeep Prabhu, Vice President Marketing and Sales, Tubing Division, SCHOTT Glass India said, “After the success of the first
THE PROGRAMME HAS SEVERAL MODULES WHICH CAN BE TAILORED TO SPECIFIC REQUIREMENTS. WITH THE ACADEMY IN INDIA Fiolax academy in Chandigarh last year, which saw the participation of more than 50 participants from pharma companies we focus on Mumbai this year. Last year’s response encouraged
us to increase participation. As India achieves new milestones at a record speed in this sector, secure primary packaging solutions have become all the more crucial. Through such training events, we help our partners improve their position in the domestic and international markets.” The programme has several modules which can be tailored to specific requirements. With the academy in India, SCHOTT Glass India offers leading pharma companies there an opportunity to learn more about benefits of using high-quality primary pharma packaging made of glass. EP News Bureau-Mumbai
COMSOL opens new office in Delhi New office offers closer proximity to companies and scientific institutions in Delhi and other areas in North India
February 16-28, 2013
OMSOL, a leading provider of multiphysics simulation software, has opened a new technical sales and support office in New Delhi. It has recently hosted an event to mark the opening of its second Indian office. Dr Amit Gupta, Assistant Professor, IIT Delhi and Vineet Dravid, Managing Director, COMSOL Multiphysics, were the key speakers for the event. The continued expansion follows as a result of the successful introduction of COMSOL Multiphysics software in the Indian market through the company's office in Bangalore. With this new
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office, COMSOL further strengthens its presence in Delhi and other areas in North India: the hub of various government organizations, academic institutes and major manufacturing companies. “A strong presence in India is key for growing our software business. In New Delhi, we see a great opportunity to enter one of the world's leading high-tech communities," says Farhad Saeidi, President, COMSOL AB and one of the founders of the COMSOL group. “The region's highly skilled engineers understand the advantage of using simulation for www.expresspharmaonline.com
product development and research. They represent the ideal target group of new users of COMSOL Multiphysics.” Vineet Dravid, Managing Director, COMSOL Multiphysics says, “We are excited to have a full fledged COMSOL office in New Delhi. The growing research, engineering and educational activity in Delhi and surrounding areas like Chandigarh, Punjab, Haryana and Uttar Pradesh made this location an obvious choice. This office will bring us closer to the high-tech centre of northern India and enable us to better serve this rapidly
expanding market with multiphysics simulation software and services.” Lakhvinder Singh will spearhead the entry of COMSOL into North India. Gradually, increasing the team size and reach of COMSOL Multiphysics will be the objective of the Delhi office. COMSOL has recently hosted an event to mark the opening of its second Indian office. Dr Amit Gupta, Assistant Professor, IIT Delhi and Vineet Dravid, Managing Director, COMSOL Multiphysics, were the key speakers for the event. EP News Bureau-Mumbai EXPRESS PHARMA
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VALUE AD Why cold form laminate Panblok is more beneficial for tablet packing compared to strip-pack? Dr Erwin Pasbrig, Director, R&D, Ansapack, in a white paper mentions about the benefits of Panblok blister
he first aluminium laminate for packaging of tablets was aluminium/poly = strip-pack. On ensuring tight sealing and no channels in the sealed seams, protection against moisture and light is achieved. Why is the Panblok blister more suitable for packaging pharmaceutical products?
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No or very minimum heat influence on sealing For this reasons gelatine capsules (soft; hard) and products sensitive to temperature can also be packed. No risk that capsules stick to the sealing layer because PE became too soft during sealing.
No mechanical demand Using strip-pack both webs are stretched over the product. Products sensitive to breaking can be partially or completely broken; hart gel capsules dented. Especially if the calculation of size of pocket is too small ('cost saving') the aluminium can get pinholes or break. In addition a lot of wrinkles will be created during sealing.
can not be achieved).
Product 1 and 2: size of Panblok blister and pack:
Type of opening Because of the four sided sealed area around each product it can only be removed from the strip-pack by tear open. Pushing through the Al/poly laminate is not possible. Peelable opening would be possible with a special design and cross perforation. This would increase the size of the strip further.
product 1
Panblok速 blister
Package material consumption
Panblok速 blister
When comparing the packing of the same tablets in a strip-pack and Panblok, less material is needed for the cold form blister. The use of packing materials for Panblok and strip-pack for a blister / strip has been calculated as follows: product 1 2
diameter height 10.00 4.9 - 5.3 9.60 4.0 - 4.4
product
tablets per blister
1 2
strip
strip
cavity per radius strip 10 8.41 11.54 21
blister length - width 10 109 - 45 21 142 - 62
product 2
Panblok sqm 0.004905 0.008804
diameter cavity of Panblok 17 16
strip length - width 135 - 60 170 - 80
sqm 0.008100 0.013600
Packaging of powder Inhalation powders cannot be taken from a strip-pack (compressing of powder and so fine critical particle mass
product
1 2
tablets per
weight
blister/strip Panblok blister 10 1.469 21 2.636
(g) strip 1.879 3.155
difference (g) 0.410 0.519
Strip / Panblok 1.28 1.20
Strip / Panblok 1.65 : 1 1.54 : 1
It can be clearly seen from the above two examples that considerably less material is needed for the package with Panblok than for the strip-pack. Beside the size reduction the weight is reduced of primary packaging material and so the weight, cost and necessary space for folding carton, tertiary and shipping packaging.
PRODUCTS Thermo Fisher Scientific launches Thermo Scientific Dionex UltiMate 3000 BioRS system T hermo Fisher Scientific has introduced the Thermo Scientific Dionex UltiMate 3000 Biocompatible Rapid Separation (BioRS) system, designed to bring highly flexible UHPLC separation capabilities to a wide range of bio-pharmaceutical research and QA/QC analyses. The UltiMate 3000 BioRS system has an extensive selection of modules that supports high resolution separations for R&D and also high throughput analyses for QA/QC on the same platform, at pressures up to 15,000 psi.
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Options include wide selections of pumps, detection techniques, fraction collectors, and auto-samplers. The platform is designed for easy method transfer between different stages of pharmaceutical product development and production. Thermo Fisher Scientific offers dedicated bio UHPLC consumables that help the UltiMate 3000 BioRS system perform quickly and well in a variety of modes, including those requiring harsh solvents. These include gold standard Thermo Scientific www.expresspharmaonline.com
ProPac WCX protein columns for QA/QC, UHPLC ionexchange columns, and a wide range of mixed mode and HILIC columns. Biocompatible capillaries with the Thermo Scientific Dionex Viper Fingertight fitting system are designed for rugged, virtually dead-volume-free connections. Contact details: Sonya Pelia 1214 Oakmead Parkway Sunnyvale, CA 94085 USA Phone: +1 408 481 4172 sonya.pelia@thermofisher.com February 16-28, 2013
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Washing units by EL and BEE Industries High speed multi needle high pressure hot water jet washing unit GMP Model: LB-2-RCH and
Ultrasonic ampoule / Vial Wash The specifications are Depends upon
● Power:
your
selection ● Dimension: 3 Tray: L. 0650 mm
X B.0650 mm X H.1200 mm
LB-S-RCH Its specifications are as follows:
● 6 Tray: L. 1300 mm X B.1300
mm X H.1200 mm
● Power: Motor: 0.25 HP, 4.5 HP,
● Washing speed: Depends upon
440 Volts A.C. Heaters/Steam for Hot Water Dimension: L. 1500 mm X B.1500 mm X H.1200 mm Washing speed: Range of ampoules: 1 to 25 ml Output: 200000 to 70000 per shift Range of vials: 2 to 30 ml Output: 140000 to 44000 per shift, Output: 35000 to 6000 per shift Range of bottles: 50 to 450 ml Output: 22000 to 4500 per shift Extra Option on above model: Steam, silicon, ultrasonic attachment
ampoule / vial washing unit in operation. Normally this unit is capable to give same output of our all models.
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Contact details: El and Bee Industries 189/3/5, Ganesh Nagar, Masjid Rehmat Road, Kandivli (West), Mumbai - 400067. Tel: 91 22 2967 4019 / 2967 5672 Fax: 91 22 2967 5672 Mob: T. Bharat – 91 98202 37693, Biju Bharat – 91 98209 70189 E-mail: elandbee@vsnl.net Website: elandbee.com
Shree Gaurav launches silicone transparent tubing S hree Gaurav’s medical grade transparent silicone tubing has the following important features: Made from medical / food grade transparent silicone rubber which complies with USP class VI requirement and FDA21 CFR 177.2600. Silicone can be obtained in a range of qualities resistant to temperature from -116OC to +315OC. It remains unaffected by most water soluble materials. Outstanding physiological properties is better than that, obtainable with any other elastomers available. It is highly resistant to UV (Ultra violet), heat,
February 16-28, 2013
cold, ozone and gamma radiation. Flexibility excellent – can be both stretched or compressed. Sterlisable by dry heat, steam, ethylene oxide (ETO) and gamma radiation. It has very-very long shelf life and is available in ranging from 0.5mm ID to 50mm ID. It doesn’t support bacterial growth, non reactive to body tissues and fluid and non-adherence to tissues. Contact details: Shree Gaurav Rubber Products 112/B, Marudhar Indl. Estate,Opp. Old Syndicate Bank, Goddev Road, Bhayandar (E) Dist. Thane – 401 105 Tele-Fax: 91 22 2819 7355 ? Mobile: 91 98924 14152 / 98204 69764 E-mail: sari@mtnl.net.in/gaurav_rubber@ rediffmail.com Website:gauravrubbers.net www.expresspharmaonline.com
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Cognex Corporation's OCRMax technology includes automatic tuning capability ognex Corporation announced that its industry-leading OCRMax technology now includes an automatic tuning capability. This new autotune feature makes complex OCR applications simple for even the novice user and is available in the In-Sight Explorer 4.8 and VisionPro 8.1 software releases. When a user clicks the auto-tune button, the system acquires a sample image and automatically adjusts the tool to its optimal parameters for robust reading performance. The advanced OCRMax algorithm prevents misreads and provides easy font management for optical character recognition and verification (OCR and OCV) applications (e.g., decoding human-readable date or lot codes or serial numbers). OCRMax is an all-in-one tool that can handle character variations, text skew, proportional fonts and variable string lengths, while providing high read rates, reduced set up time, and faster deployment.
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Contact details: Sunil Vaggu Marketing Specialist Cognex Sensors India
Level 6 - Pentagon Towers PII Magarpatta City, Hadapsar, Pune - 411028 Mobile:+91 9881466003
Tel no:- +9120 40147840 Fax:- +91 20 66280011 email: vaggu.sunil@cognex.com www.cognex.com
Thermo Fisher Scientific launches innovative AcroSeal packaging hermo Fisher Scientific has introduced new and improved AcroSeal packaging designed for air- and moisture-sensitive Acros Organics reagents and solvents. The new packaging better maintains chemical integrity, reducing the cost associated with purchasing replacement products. Ideal for aggressive solvents and reagents, the adhesive-free AcroSeal packaging significantly reduces the rate of moisture uptake and the risk of contamination in tests comparing tetrahyrofuran in the new AcroSeal packaging and in a competitor’s packaging. It features an innovative, patent-pending quadrant septum, developed from a polymeric elastomer coated with inert fluoropolymer. With multiple layers, the septum holds its shape and forms a superior re-seal after puncturing to withdraw chemicals. With a large surface area, the convenient quadrant-style screw cap provides easier access to larger volumes of solvent and supports multiple punctures to the septum, further minimizing contamination risk. Extra-dry solvents, including methanol, acetonit rile, dichloromethane and methyl sulfoxide, are available in the new and improved AcroSeal packaging. This extends across three
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different grades: standard grade solvents, which are suitable for most applications; molecular sieves grade solvents, which have been stored over molecular sieves for prolonged shelf life; and finally supreme grade solvents, which have been filtered through 0.2 micron filters. The new packaging will be available for other Acros Organics product groups in the near future. Contact details: Marcia Goff, Thermo Fisher Scientific Tel: +1 508-482-7013 marcia.goff@thermofisher.com
www.expresspharmaonline.com
February 16-28, 2013
PHARMA TECHNOLOGY REVIEW CASE STUDY
Wanbury gives managers access to analysis on mobile devices
W H AT ’ S INSIDE
Anthem BioSciences reduces costs and strengthens business continuity with Citrix PG 70
QlikTech, provider of business intelligence solution in a case study states how Wanbury, a pharmaceutical company, with a strong presence in active pharmaceutical ingredients, has utilised QlikView (product from QlikTech) to improve its business discovery capacity
IT@ PHARMA anbury is a fastgrowing pharmaceuticals company with a strong presence in active pharma ingredients — substances or compounds used in the manufacture of pharma products. Based in Maharashtra in western India, Wanbury specialises in domestic branded formulations for the rapidly expanding market in India. It’s rated among the top 50 companies in the country by specialist research consultan-
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cy ORG IMS. Wanbury is the largest manufacturer of wellknown drugs such as metformin, tramadol and salsalate for the US market and exports products to more than 50 countries. Wanbury seeks business discovery platform to analyse 'big data'. With its business expanding, Wanbury wanted to improve its business discovery capacity to satisfy an increasingly mobile executive team, as well as enable complex analysis and drill down into big data. The company previously used exporting data from various standalone applications into Microsoft Excel spreadsheets to gener-
ate largely static BI reports. The system had several drawbacks, including reduced accountability for, and visibility of, organisational and individual performance. This, in turn, often delayed decision making by senior management and heads of departments. Pandurang Salunkhe, the recently appointed Head of IT, with extensive experience in the pharma industry says, “Drill up and drill down features into key performance indicators weren’t available. This meant that the IT team created multiple reports to present the same data at different levels. In addition, static reports led to duplica-
tion of analysis and resulted in inefficiencies.” The reporting solution was also unable to provide analysis trending capabilities to executives who were on the move or away from the office. Asfhan Neverekar, Senior Manager—IT, Wanbury says, “The major challenge we faced was gaining access to business discovery reports from any device— including android phones and iPad devices — for our executive team. We needed to simplify decision making, giving staff access to information from anywhere.”
QlikView emerges as preferred solution for Wanbury In seeking a replacement for legacy system, Wanbury considered a number of traditional BI vendors, but QlikView 11 emerged as the preferred business discovery platform. QlikTech partner QuoSphere Infosolutions managed the systems integration and completed the deployment work and training by May 2012. Salunkhe says, “Deployment of QlikView happened quickly and change management was smooth. The whole implementation took just three months. QuoSphere Infosolutions delivered many quick standard reports and further customised them to meet our specific business needs.” Wanbury values the
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P|H|A|R|M|A| T|E|C|H|N|O|L|O|G|Y| R|E|V|I|E|W cross-platform accessibility of QlikView, especially because a number of different operating systems— including Windows and Mac OS—are in use throughout the company. Neverekar says, “In QlikView, the associative inmemory technology allows users to analyse the data quickly. Its platform independent, and the mobility access in QlikView 11 across iPhone, iPad, and Android devices is appealing.”
Easy integration with existing data sources favours QlikView Wanbury likes the fact that QlikView has been designed to tightly integrate with exist-
WANBURY IS PLANNING TO EXTEND ITS USE OF QLIKVIEW TO THE FINANCE AND RESEARCH AND DEVELOPMENT BUSINESS UNITS IN ITS UPCOMING FINANCIAL YEAR
ing security systems and data sources, thus preserving current IT investments. Salunkhe says, “The rapid access from QlikView to many types of analytics through various reports happens without disturbing the source system performance. Wanbury has various data source systems, but they’re all located centrally so integration of data sources was easy.” Wanbury employees are using a QlikView SAP Connector to analyse inhouse SAP data quickly and easily. Salunkhe says, “QlikView, through its inmemory associative technology, delivers rapid data visibility and unprecedented decision-making agility for all
Wanbury business and technical users. We use a single product instead of requiring a stack of BI products.” Wanbury is planning to extend its use of QlikView to the finance and research and development business units in its upcoming financial year. Neverekar says, “QlikView is a highly costeffective solution compared to other business discovery platforms on the market. The self-service analytics saves a lot of time for the IT team, which can now get on with more productive work. With QlikView, we have successfully built a uniform reporting layer for different heads of departments and executive managers.”
Anthem BioSciences reduces costs and strengthens business continuity with Citrix Anthem BioSciences explains how implementing a Citrix XenDesktop Solution helped the company to streamline its operations and gun for better growth
IT@ PHARMA nthem BioSciences is a Bangalore-based DRAP (Discovery Research Alliance Partner) dedicated to supporting research efforts for the discovery of new compounds in pharmaceutical, biotechnology, specialty chemicals, agriculture chemicals and material science companies. Anthem is a group of companies, that includes Anthem BioSciences, Anthem Cellutions and Anthem BioPharma, [formerly Vestas Life Sciences]. The company employs over 450 people at its Bangalore facility and has plans to have a remote site in the next two years. The company was founded in 2006 by Ajay Bharadwaj, K C Ravindra and Ganesh Sambasivam, they were all previously senior executives at Biocon. Anthem BioSciences does research for global pharma giants in the US and in Europe, they focus on research, manufacturing and drug discovery services. Anthem Cellutions is a product and R&D based company in the area of biotechnology. They manufacture enzymes, nutraceu-
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ticals and pharmaceutical products that have a widevariety of uses in various industries. Anthem BioPharma was created by the acquisition of Vestas Life Sciences and it focuses on formulations. At Anthem BioSciences, all data and applications reside in the datacentre. Whenever there is a need, the desktops are delivered to the end user. It has a SAN (storage area network), that connects users to the data centre. “We have end-to-end security including port blocking, firewalls, routers, monitoring tools, web filters, and anti-virus at the gateway level. We manage the critical infrastructure that supports all our operations,” said Ravi Kalla, Senior Manager IT at Anthem BioSciences.
The triple challenge Anthem BioSciences started operations with just 50 people in early 2007. Today, it has over 450 employees across all verticals. At the existing facility the company is in the process of doubling its capacity and there are expansion plans for a remote location. The recruitment process is in full swing to bring more talent into the organisation. It is becoming a big challenge for IT to provision enough new desktops every month to keep up with the number of new employees. “We had to provision 2550 desktops/laptops every www.expresspharmaonline.com
Of all the options, Citrix came closest to fulfilling our needs. It was cost effective and had superb features like hosted shared desktop services. It was a clear competitive win for Citrix XenDesktop solution as it provided a much better ROI Ravi Kalla, Senior Manager IT Anthem BioSciences
month, and it was very time consuming for IT,” said Kalla. “We are a start-up. There was no way we could afford to have clustering and patch management software. So while looking for clustering solutions, we thought that server virtualisation and desktop virtualisation could help us address the challenges,” he added. Recently Anthem deployed four different server applications. In a traditional model, they would have needed four physical servers to support them because some of them are Linux based and some are Windows based. So IT needed to invest ` 10 lakh; if they went for the n+1 concept this would have required an investment of ` 40-50 lakh. “Since we went for server virtualisation, without buying any new hardware, we just created a virtual environ-
ment and hosted the servers. So the cost of doing this was zero. This was a major business advantage of the Citrix XenServer virtualisation solution for Anthem,” said Kalla. The company has now implemented complete virtualisation, from server to hosted shared desktop service all provided by Citrix.
Secure remote access Anthem wanted to extend a remote working opportunity to some of its employees but data and information security concerns had prevented them from taking any steps in that direction. Anthem BioSciences has to send regular updates out to its customers and so it could not afford any workflow breakdowns. “We wanted to get better control of dataflow because there was always the fear of security breaches. Whenever we sign a non-disclosure agreement with companies, security is a non-negotiable issue,” said Kalla. “For example, if we are sending an update to the customer and the desktop suddenly crashes, the email client and applications have to be reconfigured in a different location. This would result in a loss of productivity and a delay of at least 2-4 hours and it would affect our business continuity,” commented Kalla.
Implementing the February 16-28, 2013
P|H|A|R|M|A| T|E|C|H|N|O|L|O|G|Y| R|E|V|I|E|W Citrix desktop virtualisation solution Given these business needs and the technology challenges, Anthem BioSciences decided to deploy a virtual desktop infrastructure. Before selecting any product, Anthem did a full due diligence on every worthwhile option. They evaluated various options including VMware and Citrix. “Of all the options, Citrix came closest to fulfilling our needs. It was cost effective and it had superb features like hosted shared desktop services. It was a clear competitive win for Citrix against VMware as Citrix XenDesktop was also able to provide a much better ROI,” said Kalla. To date Anthem BioSciences has purchased 200 licenses of Citrix XenDesktop and is planning further expansion. “Although VDI (virtual desktop infrastructure) is slightly expensive because you have to buy Microsoft licenses and an annual subscription for VDI infrastructure, Citrix still made the most sense as compared to other products,” said Ravi. Anthem BioSciences opted for a hosted shared desktop (HSD), as it is a lightweight component, and most of the users require only browser and Java. In the case of Citrix Hosted Shared Desktop (HSD) services, after buying terminal licenses, the desktop is available to the end user. The look and feel is similar to a normal desktop, but it is extremely cost-effective and lightweight. “You don’t require highend features at your datacentre or at your distribution site because the bandwidth consumption is very minimal. Also, Citrix can run on any device. You don’t require any WAN optimisation tools to achieve better access speed,” commented Kalla.
Citrix XenDesktop saving time and money Post virtualisation, the IT organisation at Anthem BioSciences breathes easy. Thanks to the virtual desktop, the entire desktop is encrypted and delivered to the user, therefore leaving no room for any internal and external security breaches. “We feel virtualisation was the best way to address most of our secured remote access concerns. Now users can access their office desktops from remote locations. February 16-28, 2013
Key benefits ● ● ● ●
Reduced significant costs Secure remote access Business continuity Faster deployment
Whatever they need to do, will be at the datacentre and not on the desktop,” said Kalla. With Anthem being a start-up, it was important for the IT team to keep a tight control on costs. The numbers are good, a well configured desktop costs a minimum ` 25,000. Plus the cost of Microsoft Windows 7 professional license, this costs ` 9,000. So the total cost of the desktop becomes ` 34,000 and that’s before you add in the cost of other software like anti-virus, port blocking etc. “In the thin client model the hardware cost is just ` 14,000. Even with the cost of licenses, the cost will not be more than ` 22,00. This is an immediate saving of ` 12,000,” said Kalla. “The Citrix XenDesktop deployment has resulted into huge cost-savings for us. Plus our concerns relating to security, business continuity and deployment of applications have also been addressed,” he added. Since Citrix XenDesktop was deployed the IT team does not have to worry as much about business continuity; even in the case of a system crash the user can log in and start work from where they left off. “We have created roamwww.expresspharmaonline.com
ing profiles, so a user can go to any computer and access the applications that are tagged to their ID, including the mailing solution and printer access,” said Kalla. The lifecycle of a normal desktop is usually three to four years, whereas a thin client can work for as long as seven years. The power consumption of a desktop is 100140 watts, whereas thin client consumption is only about 40 to 50 watts. “There is a significant saving on power. If 200 conventional desktops run for 12 hours, the cost of power comes in at ` 30 lakh per annum, as opposed to thin clients, that may only cost about ` 10-15 lakh,” he added. Previously for 200 desktops, the IT team at Anthem BioSciences needed a minimum of two-three weeks to deploy. However, now with Citrix XenDesktop in place, deployment is much faster and can happen on the same day. “In the past around 150 computers were never shut down and this meant the company was incurring some huge energy bills. In the virtualisation model, the power cost is much reduced as the systems are shut down every day. Other hidden costs are also being discovered and reduced,” said Ravi. With the huge expansion plan now underway, the company has recruited 100 scientists in the last few months. Thankfully post virtualisation deploying desk-
tops has become much faster and easier. “Deploying and configuring desktops in the 1:4 model used to take at least 10 days but now it is no longer a hassle,” said Kalla. “With the latest Citrix HSD, one physical server with 128 GB RAM and Xeon processor can support 200 users in a lightweight environment. We were initially apprehensive about putting so many users on to the server but after seeing the performance in the last four months, we are confident that it can support more than 200 users,” he added. As the Hosted Shared Desktop (HSD) does not consume more bandwidth, Ravi can now access his desktop with the use of a TATA Photon data card. “I am able to access my entire desktop from a remote location. That is the biggest advantage,” said Kalla.
Applications delivered ● ● ● ● ●
Open Office 3.4 Chemistry and Life Sciences Software Internet Explorer, older versions if required Java Firefox
Networking environment ● ● ● ● ● ● ●
Citrix XenDesktop 5.6 Citrix XenServer 6.0 Dell blade servers Microsoft Windows 2008 R2 Enterprise version SAN Architecture Dell Equallogic Dell Force-10 Wyse Thin Clients. EXPRESS PHARMA
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AWARDS Ranbaxy honours outstanding scientists and young science scholars
anbaxy Science Foundation (RSF), a non-profit organisation set-up by Ranbaxy Laboratories (Ranbaxy), announced its XXVII Annual Research Awards for the year 2011 to Indian scientists in recognition of their outstanding research contributions in the fields of medical and pharmaceutical sciences. The foundation also announced its VI Annual Science Scholar Awards to the upcoming new generation of scientists. The awards were presented by internationally acclaimed scientist, Prof Dhavendra Kumar, Consultant in Clinical Genetics, Institute of Molecular and Experimental Medicine, University Hospital of Wales, Cardiff, UK, at a function held in New Delhi. Dr Tsutomu Une, Chairman, Ranbaxy, Dr Nitya Anand, Chairman of RSF, Arun Sawhney, Chief Executive Officer and
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Managing Director, Ranbaxy and Dr Sudershan Arora, President, R&D, Ranbaxy also addressed the gathering. Four scientists and an equal number of science scholars were honoured with the awards. Earlier during the day, Ranbaxy Science Foundation also organised its 19th Annual Symposium on ‘Gains of Genomic Research in Biology and Medicine.’ Dhavendra Kumar was the chief guest. The keynote speaker, Prof Samir K Brahmachari, Director General, Council of Scientific and Industrial Research (CSIR) delivered a special lecture at the symposium. Renowned scientists from India and abroad deliberated on the theme. The symposium was conducted in association with Department of Transplant Immunology and Immunogenetics, All India Institute of Medical Sciences (AIIMS), New Delhi and Immunology Foundation of India was the co-sponsor. www.expresspharmaonline.com
Ranbaxy Research Awardees-2011 Category: Medical Sciences – Basic Research Awardee: Prof Tapas Kumar Kundu Sir JC Bose National Fellow, Transcription and Disease Laboratory, Molecular Biology and Genetics Unit, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bangalore Contribution: Epigenetics and gene regulation with special emphasis on disease. Developing a nano device to induce acetylation of histones in the mice brain. Kundu completed his post-graduation and doctorate degree from the Indian Institute of Science, Bangalore, in 1995. Following this, he had a short stint as a visiting foreign research associate in the National Institute of Genetics, Mishima, Japan during which he contributed
to the field of prokaryotic transcription. He then headed to Rockefeller University, New York, for his post-doctoral work (1996-99), where the focus of his work shifted to epigenetic regulation of eukaryotic transcription, a field in which he continues making seminal discoveries till date. He joined JNCASR as a faculty fellow in 1999, and is now a professor. He has done extensive work in the area of regulation of human gene expression (transcription) and its link to disease and therapeutics which is being used to design new generation cancer diagnostics, as well as therapeutics for cancer, AIDS and diabetes. He is also the recipient of Giri Memorial Award for best thesis in biochemistry and Shanti Swaroop Bhatnagar Award. Category: Medical Sciences - Medical Research Dr Satish Kumar Gupta Deputy Director and Chief February 16-28, 2013
P|H|A|R|M|A| L|I|F|E Reproductive Cell Biology Laboratory National Institute of Immunology(NII), New Delhi. Contribution: Helping understand the molecular basis of mammalian fertilisation and providing critical insights to the zona pellucida-based contraceptive vaccines. Gupta did his BSc from Delhi University, MSc in Medical Biochemistry as well as PhD (Biochemistry, 1983) from All India Institute of Medical Sciences, New Delhi. In 1982, he joined as research officer at the newly established, National Institute of Immunology (NII), New Delhi, and worked as a Visiting Fellow or Professor at various institutions including Institut Pasteur, Paris; The Jones Institute for Reproductive Medicine, Norfolk, USA and The Johns Hopkins University, Baltimore to name a few. He has also contributed in the development of indigenous diagnostic kits for pregnancy detection, identification of group-A streptococci in throat swabs and antibodies in the serum against HIV-1 and HIV-2 infections. His group is also engaged in identification and isolation of plant-based compounds having anti-HIV activity. He has published approximately 169 research
papers and mentored close to 12 PhD students. Medical Sciences - Clinical Research Prof Arun J Sanyal Charles Caravati Prof of Medicine Virginia Common wealth University School of Medicine, Richmond, USA. Contribution: Pioneering work in the areas of nonalcoholic fatty liver disease (NAFLD) and cirrhosis. Sanyal earned his undergraduate degrees from Patna University and Maulana Azad Medical College followed by Doctor of Medicine degree from the All India Institute of Medical Sciences (AIIMS), New Delhi. He completed a residency in internal medicine at the AIIMS, a residency in internal medicine at Texas Tech University Health Sciences Center in Amarillo, Texas, and a fellowship in gastroenterology and hepatology at Virginia Commonwealth University School of Medicine, until being named Professor of Internal Medicine, Gastroenterology, Haepatology and Nutrition. A member of the American College of Gastroenterology, Sanyal is the author of more than 100 articles in such publications as Gastroenterology, Hepatology and the Journal of Infectious Diseases. His research interests include
clinical studies in liver disease, hepatic neovascularisation and genesis of TIPS stenosis, and the development of effective therapy for non-alcoholic steatohepatitis. Pharmaceutical sciences Dr Navin Khanna Senior Scientist and Group Leader Mammalian Biology Division Recombinant Gene Products Group International Centre for Genetic Engineering & Biotechnology, New Delhi Contribution: Pioneering contribution in the field of viral diagnostics through the design and development of novel, inexpensive, highly sensitive and specific recombinant proteins. Khanna holds a Doctoral Degree in Biochemistry from AIIMS, New Delhi. For the past 20 years, he has been working on genetically engineered bio-molecules of medical use at ICGEB, New Delhi. He was an Alberta Heritage Foundation Fellow at Cell Regulation Group, University of Calgary, Canada (19841987) and worked as a Post Graduate Research Biologist at the Center for Molecular Genetics, University of California, San Diego, La Jolla, CA, US (1987-1989), and later as a Research Assistant Professor, at the Department of Molecular Biology and
Biochemistry, University of California, Irvine, CA, USA (1989-1990). Khanna has published more than 85 original research papers and five reviewed articles in national and international journals and books. He has been an author on six patent applications. His research activities have been also focused towards the development of a sub unit based dengue vaccine. Ranbaxy Science Scholar Awards-2012 Bio-Medical Sciences Manish Goyal, Senior Research Fellow, Division of Infectious Diseases and Immunology, Indian Institute of Chemical Biology, Kolkata Seema C Parte, PhD Candidate & Senior Research Fellow, Stem Cell Biology Department, National Institute for Research in Reproductive Health, Mumbai. Pharmaceutical sciences Pawar Yogesh Bapurao, PhD Scholar, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab. Aakanchha Jain, Pharmaceutics Research Laboratory, Department of Pharmaceutical Sciences, Dr HS Gour University, Sagar, Madhya Pradesh. EP News Bureau— Mumbai
APPOINTMENT Huntsman appoints Steve Stilliard as Vice President and Managing Director, Indian subcontinent The new role based in Mumbai has been created to provide leadership for Huntsman’s rapidly expanding presence in the subcontinent untsman Corporation announced the creation of the new position of Vice President and Managing Director, Indian subcontinent and has appointed Steve Stilliard. Stilliard was previously Vice President, Asia-Pacific, of Huntsman Corporation’s Performance Products division. The new role based in Mumbai has been created to provide leadership for Huntsman’s rapidly expanding presence in the subcontinent. Stilliard will report to Paul Hulme, President, Huntsman’s Textile Effects division and the senior executive responsible for the
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Indian subcontinent. He will coordinate the corporate and cross-divisional activities required to deliver growth, including investments and partnerships, strengthening the company’s asset base, developing people capability and building relationships with governmental organisations and other key stakeholders. As a native of Cornwall, UK, Stilliard studied at the University of Wales before launching his career in the chemical industry in 1973 with Albright and Wilson in the UK where he stayed 28 for years. During this time he held a wide range of increasingly senior positions www.expresspharmaonline.com
in finance, planning, IT and general management both in Europe and Asia Pacific, including a stint in 1998 to 1999 as Managing Director of Albright and Wilson Chemicals (India).
Commenting on the appointment, Peter R Huntsman, President and Chief Executive Officer, Huntsman Corporation said, “This appointment recognises the need to accelerate our investment in people and physical assets to strengthen our long-term position in this exciting market, which already accounts for over $500 m of our sales and over 1,000 associates.” Huntsman added, “Steve Stilliard has extensive experience of working and living in the region, a proven track record in building successful businesses in emerging markets and has a deep understanding of the Huntsman business and culture.” EP News Bureau —Mumbai EXPRESS PHARMA
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CAMPUS BEAT Seminar on ‘Dissolution Challenges-Regulatory Perspective’ held at JSS University, Mysore Over 250 delegates participated in the seminar
isso 2013, the two-day national seminar on ' D i s s o l u t i o n Challenges-Regulatory Perspective' recently concluded at Department of Pharmaceutics, JSS College of Pharmacy (off campus JSS University, Mysore), Udhagamandalam. The welcome address was given by Dr K Elango, Principal, JSS College of Pharmacy, Udhagamandalam. Over 250 delegates from within India and abroad participated in the seminar.
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Pharma HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Dr Raghu Pillai The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor, Whites Road, Royapettah, Chennai - 600 014
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Dr VP Shah, Former, Senior Research Scientist, US FDA, VPS Consulting, MD, US; Dr Suresh Venkataram, Chief Executive Officer, Semler Research India Bangalore; Dr L Ramaswamy, General Secretary-SPDS and Managing Director-Sotax India; Ramsingar Pal-General Manager (Technical), Sotax India, Mumbai; Aditya Marfatia, Director Electrolab, Mumbai; H Raghunandan, Associate professor, JSS College of Pharmacy, Mysore; Dr B Suresh, Vice chancellor, JSS University, Mysore; Prof K Chinnaswamy and Dr K Gowthamarajan, Prof and Head, Department of Pharmaceutics, JSS College of Pharmacy, Udhagamandalam, graced the occasion. Gowthamarajan presented the genesis of the conference and highlighted the importance and need of dissolution. Chinnaswamy, Emeritus
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Professor and guest of honour, addressed the audience and also highlighted scholarships offered by Tamilnadu Pharmaceutical Sciences Welfare Trust and seven students were awarded with cash prize and certificates. Suresh delivered the presidential address and highlighted the recent trends in dissolution and monographs for herbal drugs in upcoming Indian Pharmacopoeia. He also addressed the challenges being faced by industry in times of bio waivers and generic drug development with particular emphasis on biological, vaccines and monoclonal antibodies. The first scientific session was initiated by Shah where delivered a talk on Dissolution: Its place in pharmaceutical development and manufacturing, what is bioequivalence and how to document it, regulatory require-
2231 8879 / 80 Fax: +91-33-22138582 Cell: 09830130965 / 09831182580 Email: prasenjit.basu@expressindia.com ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732
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ments and regulatory applications, and drug release from novel dosage forms. The second scientific session was conducted by Venkataram and delivered talk on topics, science of dissolution, types of dissolution apparatus and selection of dissolution medium and advanced concepts in dissolution methodology (IVIVC, statistical Analysis, f2). This session was followed by a lecture by Raghunandan on Dissolution requirements for ANDA filling and Gowthamarajan on Herbal Dissolution. Ramaswamy introduced the Society for Pharmaceutical Dissolution Science (SPDS) and activities conducted by the Society. Pal spoke about Flow-through cell (USP IV) methods and its application for novel drug delivery systems. EP News Bureau —Mumbai
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