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Indian Pharma in 2020 18

Special Focus 26

Special Focus Interface 29

Book Review 25

Regulatory challenges | Manufacturing | Packaging | Legal battles | Clinical trials and research | Herbals and nutraceuticals

Pharma supply chain Time for uplifting standards

Vineet Agarwal Joint Managing Director, Transport Corporation of India Ltd (TCI)

Top 10 books of the season For an insightful read

Pharma companies refuse to accept 2D barcode mandate ith the Indian pharmaceutical industry going global, effective GMP compliance is of crucial importance to ensure that the quality of drugs are maintained and safe drugs are delivered for consumption by the masses.

The emergence of a booming export market in pharma has resulted in Government making the norms strict further. A mandate has been passed by the Government of India (GoI) to compulsorily include 2D barcode in pharma packaging. This most was received not welcome by the industry and experts.

Since this rule came into effect, the pharma majors and SMEs alike are demanding a valid explanation from the GoI for implying such practices.

The industry fears, this decision may hamper export trade of the country. Expressing resentment, Samir R Shah, Director, Ciron Drugs & Pharmaceuticals Pvt Ltd said, “The government says that the 2D barcode will define the quality of the product. Whereas, we argue stating facts that this mandate will only burden the SMEs further. We contribute a lot to the market and we are being ignored.”

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It seems difficult for pharma majors to invest into purchase of 2D barcoding machines and adopt the practices into their manufacturing and packaging processes. The 2D barcoding machines are very expensive and hence will make cost recovery difficult on the final product. Also the installation costs are so high, that companies can get swallowed or wiped out, just to bring in the machinery as a part of their system.

Apart from the above, there are various other sectoral issues.

Primarily being the rising curiosity among the industry veterans and pharma majors, questioning on why does the government mandate this norm

Snippets

Glenmark Generics gets ANDA approval for Riluzole tablets Glenmark Generics Inc, the US subsidiary of Glenmark Generics Ltd has been granted final Abbreviated New Drug Approval (ANDA) from the United States Food and Drug Administration (USFDA) for Riluzole tablets, 50mg.

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis. Based on IMS Health sales data for the 12 month period ending March 2013, Riluzole garnered sales of $ 64 million.

The company will commence shipping of the drug immediately.

Glenmark’s current portfolio consists of 86 products authorised for distribution in the US market and 52 ANDA’s pending approval from the USFDA. Additionally, the US arm of Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing portfolio.

Aurobindo receives USFDA approval for Disoproxil Fumarate Aurobindo Pharma Ltd has received the tentative approval from the US Food & Drug Administration (USFDA) to manufacture and market, Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate tablets, 600mg/300mg/300mg.

The New Drug Application

(NDA) provides for the use of Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate tablets, 600mg/300mg/300mg alone or in combination with other antiretroviral for the treatment of HIV-1 infection in adults and adolescents, more than 16 years of age and weighing at least 40 kg.

without offering any financial support to the industry? Tushar A Korday, Director, EMIL Pharmaceutical Industries Pvt Ltd said, “Getting a machine for 2D barcode is not easy for every small enterprise. It costs a fortune and thus this will impact the sector.

Many companies will shut down if this is made compulsory. Most importantly, there is no financial aid from the government which is a worrisome factor for us.”

Practical implications include that the 2D barcode cannot be read by a regular barcode reader.

This requires a different machine.

Plus, the material used to make cartons has to be of a very good quality such that the barcode can be imprinted properly without

any fault. Most of the products manufactured by SMEs in India are exported to Africa and other similar nations. With the 2D barcode coming into picture, these countries might stop importing products, as the prices will subsequently rise. Also with no proper 2D barcode system in place to read the barcode, the system as a whole will stand under-utilised.

Shah reiterated, “We are certainly not happy with this decision and have been trying to reach the officials but have always been met with disappointments. It is shocking that the government is simply taking decisions, without realising and properly calculating the consequences of it.”

After analysing the entire situation, it is the industry’s dictum to not favour the 2D barcode implementation as it may hamper business of the SMEs in particular. Installation of the barcode system will approximate to ` 50 lakh. However, various attempts to get government’s reaction on the industry’s nonacceptance regards the 2D barcode mandate have proved unsuccessful yet.

Anubhav Sharma

Novartis positive about Omalizumab for patients with chronic spontaneous urticaria Novartis announced results showing Omalizumab met all primary and secondary endpoints of a pivotal Phase-III safety registration GLACIAL study for patients with refractory chronic spontaneous urticaria (CSU), a chronic and debilitating form of hives with limited approved treatment options.

Omalizumab is not currently approved or indicated for CSU. Regulatory submissions for Omalizumab in CSU are on track for later this year.

Omalizumab has been found to be effective, safe and well tolerated in refractory CSU patients, Omalizumab eliminated or suppressed symptoms in more than half of patients who failed multiple therapies in a span of 12 weeks.

GLACIAL is the second of three pivotal Phase III studies that investigate the efficacy and safety of Omalizumab in CSU. The study results support the

efficacy, safety and tolerability of Omalizumab in patients with refractory CSU. Up to 40 per cent of CSU patients fail on antihistamines, even those taking up to four times the approved dose.

Antihistamines, at the approved dose, are currently the only licensed treatment for CSU. “This is encouraging news for people living with CSU, whose quality of life is greatly impacted by this serious disease and who currently have few treatment options,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “Novartis is committed to doing, all we can for these patients by working to develop an important advance in CSU treatment, where unmet medical need remains high.”

Omalizumab is being jointly developed by Novartis and Genentech, Inc, for CSU.

A peek into 2020

Anniversary Attractions Indian pharma in 2020

M o d e r n P h a r m a | 1-15 July 2013

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Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Legal battles

Patents vs generics: Who will rule?

India being a progressing economy, product innovations attract very few investments from the industry players.

Increasing costs of drug development are a mammoth hindrance for countries like India. Being a leader in reverse engineering innovator drugs, India has made a definitive mark for itself in the global healthcare market. ith niche markets such as biologics, biopharmaceuticals and contract research gaining momentum, and their patents expiring in the next few years, pharma players are taking keen interest in the generics segment. Moving up the value chain would require Indian pharma companies to upgrade their profiles in the international market.

USA and Europe is also dispensing a good number of generic drugs to the patients. However, there seems to be an urgent need in the west to shift focus back to research.

Between 1995 and 2013, the Intellectual Property Rights (IPR)/ patent river has been flowing turbulently enough. The ‘doomsday omens and prophecies’ by pharma pundits have been proved wrongtill now. Early grant of product patents, post-2005 did result in extensive, often frivolous infringement suits, injunctions, counter claims and revocations. Other than the section 3(d) litigations, majority of suits and writ petitions were relating to patent-regulatory linkages. Despite early settlement by the Delhi High Court and the Supreme Court, the legal battle continues to be dragging on in various courts, owing to adjournments. ‘Patent is valid, but not infringed’ judgements are under appeal by both sides. Frivolous

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Q&A with

How do you visualise the outcome of the patent vs generics war in India?

The entire world market is moving towards generics. Even in US over 75 per cent prescriptions in the year 2012 were for generics. However, patents and generics are two sides of the same coin.

Only when someone discovers a new molecule, patents it and when the patent expires, it becomes generic. Unfortunately in India, even valid patents have been infringed through compulsory licensing because of ambiguous criteria like ‘not worked in India’ or ‘affordability.’ This is an unhealthy trend which will certainly impact innovation and investment in research.

litigations on incremental innovations, between Indian pharma companies are mostly driven by ‘market-share’ egotrips are also increasing.

To predict the pharma scenario in India in 2020 with specific reference to patented molecules and dosage forms vis-à-vis generics is no tall order. Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, opines, “Generics are here to stay and will continue to be in the pink of health in 2020 too. By 2020, the early challenges to patented molecules viz, New Chemical Entity (NCE) will substantially diminish.

However, licensing of patented molecules to Indian domestic companies (often more than one) will increase substantially, thereby extending the early reach of advanced ‘life saving’ and ‘quality of life’ medications to a wider cross-section of the needy community.

It is predicted that the pharma patent litigations will come down in days to come by 2020. There will be 3 types of pharma patent litigations raging in India - NGO-driven, greed-driven and ego-driven. NGO and generics driven litigations will continue to be related to lack of affordable access, non-working, government use and compulsory licenses.

The greeddriven litigations will continue to be driven by evergreening intentions despite section 3(d), especially since

the new drug pipeline is drying out.

Litigations against Indian born NCEs and dosage forms are unlikely in 2020 or thereafter, because issues like Form 27, non-working, not manufactured in the country, unreasonable price etc, are unlikely to come to play in such patents.”

“If the current trend is to be extrapolated, the third category of egodriven patent litigations is expected to increase by 2020. These litigations will follow the path of ‘mother of all ego-driven pharma patent litigations’ ie, the ‘Gleevec’ patent battle. Egodriven litigations in pharma patents are most likely to be played between Indian generic companies than between MNCs and Indian companies. MNC patent wars are mostly in the second category of greed-driven litigations. The segmentwise leadership issues, market share disputes, infringement of incremental innovations, disputes on confidentiality violations (due to migration of resources and IP stakeholders) are likely to be drivers for such pharma litigations in 2020,” Nair reiterates.

Key takeaway points Pharma industry shifting focus towards generics New drug pipeline is drying out

Generics are here to stay and will continue to be in the pink of health in 2020 too. By 2020, the early challenges to patented molecules viz, New Chemical Entity (NCE) will substantially diminish.

Dr Gopakumar G Nair CEO, Gopakumar Nair Associates

Confidentiality violations Frivolous litigations on incremental innovations

Dr Ajit Dangi President and CEO, Danssen Consulting Will India remain the largest generics producer by 2020?

For India to become a world leader in generics by 2020, it is dependent on three factors – perception about the quality of Indian generics due to recent developments, consistent and stable government policies and global healthcare reforms. India also needs to capitalise on the immense opportunity arising in the biosimilar space. China has taken over India both in biosimilars as well as APIs. Associations are helping accelerate India’s generic exports by proactively interacting with overseas governments and negotiating export friendly policies.

Do you think the race for generics will hamper innovation in drug development in India?

Increasing use of generics is a key strategy for developed countries to contain burgeoning healthcare costs. As long as the intellectual property of the discoverer is honoured, there is no need to worry about the impact of generics on innovation. However, this trend will certainly influence business models of research based pharmaceutical companies. More and more companies are likely to resort to a hybrid model of having both patented as well as branded generics in their portfolio, particularly because pharmaceutical research is increasingly becoming risky, expensive and lengthy.

Additionally, many blockbusters are nearing their patent expiry and research pipelines are increasingly getting constricted.

How will the recent developments impact Indian pharma industry?

The recent developments will act as a deterrent for investment in innovation and research not only for MNCs but for research-based Indian companies as well.

The investment will shift focus to countries wherein there exists sound ecosystem for innovation and good enforcement of Intellectual Property Right (IPR) laws in letter as well as in spirit. Countries like China, Singapore and Korea significantly attract more FDI in pharmaceuticals over India.

EU fines nine drug companies including Ranbaxy € 146-million fter USFDA rounded up on Indian generic drug makers and raised alerts on Wockhardt and Dabur plants in India, the European Union (EU) has now rounded up 9 global drug manufacturers.

India’s Ranbaxy along with Denmark’s Lundbeck have been fined a total of €146-million by the EU antitrust regulators. The fine is imposed for restricting the supply of cheaper antidepressant drugs to the market.

Lundbeck was accused of paying rival generic drug companies to delay the delivery of antidepressant drug Citalopram to the market.

According to an EU pharma report in 2009, it alleged questionable deals between branded drug majors and generic rivals, which will result in consumers paying, as much as 20 per cent more.

Earlier, US regulators said that, the deals between brand name drug companies and generic rivals which lead to higher drug prices could attract legal action.

Other companies to be fined are Generics UK, Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma and A L Industrier other than India’s pharmaceutical giant, Ranbaxy. These are the makers of generic drugs.

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st Anniversary SPECIAL

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Contents

Modern Pha rm a | 1-15 July 2013

Anniversary special Regulatory challenges Need to balance growth with compliance

Indian Pharma 2020

18 20 22 23 24 25

Pharma manufacturing Redefining operations by effective GMP compliance

Prospects and pitfalls

Pharma packaging Technology as the key leverage Legal battles Patents vs generics: Who will rule?

Clinical trials and research Collaborate to reform Herbals and nutraceuticals Catapulting market dynamics

Special Focus Pharma Logistics Pharma logistics En route to safe drug delivery

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Sourcing pharma The growth enablers Pharma supply chain Time for uplifting standards

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Interface Vineet Agarwal Joint Managing Director, Transport Corporation of India Ltd

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Regular Sections

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Editorial / Guest Editorial News, Views & Analysis Projects Tenders Event List Book Review Products Marketplace List of Products & Advertisers

s of t h g i n l Highxt Editio cus: o Ne a lF ia arm ec h Sp in p R H

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st Anniversary SPECIAL

Editorial

Modern Pharma | 1 - 15 J u l y 2 013

On the first milestone… ver the years, the Indian pharmaceutical sector has come a long way. Starting off from rather small area of operations a few years back, today it has ascended to a position of stature on the world map, as one of the key providers of healthcare products. According to a recent estimate by McKinsey & Co, the pharmaceutical industry in India is at the cusp of bigger opportunities and is projected to surge from about $ 5.5 billion in 2000 to $ 25 billion in 2020.

Among other macro trends impacting this sector, the recent highlights have been the increasing number of collaborative agreements and acquisitions of Indian pharmaceutical companies by multinationals. While the role of such sectoral consolidations cannot be underestimated towards ensuring an anticompetitive eco-system, it is important to objectively assess the impact of such takeovers and mergers & acquisitions, while providing a level playing field in the market to encourage innovation.

To be precise, there has been a growing concern in several expert circles about the acquisitions involving takeover of generic companies, presuming it may lead to a significant shift in priorities of these companies. These may have an adverse impact on the generic markets in terms of research and development, including clinical trials in particular therapeutic areas as well. Then, there are worries if the newly formed market forces would result in skewed concentration of particular therapeutic groups and products in the market.

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EDITORIAL ADVISORY BOARD Ajit Singh Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

In the light of new patent regime and a deregulated environment, the question remains, if the growth and internationalisation of the pharmaceutical sector will benefit the common man by ensuring better access to affordable medicines. More importantly, how effectively will the new paradigm shift benefit consumers and the industry at large? Will the perception at large that the pharmaceutical policy in India is an industrial policy rather than a health policy change?

Against this rapidly emerging industry trends, welcome to the 1st Anniversary Edition of Modern Pharma. This special edition not only reflects on the fast-evolving Indian pharma sector but also envisions a path forward, to take this discussion to the next level of engagement among various stakeholders. As we embark on our journey to achieve the vision 2020, the Anniversary Special section delves deeper into several significant areas such as regulatory landscape, manufacturing, packaging, clinical research et al, that hold strategic implications, in enabling the sector, to leap into the next orbit.

Have a good read and share with us your valuable feedback.

Raising a toast to this special edition, I would like to thank all our internal contributors and external stakeholders who continue to inspire us, along this incredible journey. Cheers!

Manas R Bastia manas@network18publishing.com

The healthcare albatross

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Ranjit Shahani Vice Chairman and Managing Director Novartis India Ltd

The Team Modern Pharma!

Senior Editor Manas R Bastia

Associate Vice President Sudhanva Jategaonkar

Copy Editor Savita V Jayaram

Senior Correspondent (Delhi) Nikunj Sharma

Features Writer Pallavi Mukhopadhyay

Features Writer Anubhav Sharma

Guest Editorial ndia reintroduced product patents after a long hiatus of 35 years, during this period plenty of opportunities were provided to the domestic pharmaceutical industry to establish and thrive. This opportunity, while well-meaning, is proving to be the proverbial albatross round the neck of the unsuspecting patient who is looking for options in quality healthcare.

Patents provide an incentive to the pharmaceutical industry to invest in the development of new medicines to treat diseases that were hitherto untreatable or incurable. It is certain that, patents are the lifeline of the innovative pharma industry and also of the generics in the pharma industry as well. Without patents there will be no research; without research there will be no innovator drugs; and without new drugs there will be no new generics.

India is a vast country with a burgeoning population. In reality, it is existence of two markets in a country with varied healthcare needs. There are the rich, who can afford world-class healthcare and at the other end, the poor populace for whom quality healthcare is not affordable at any price. This situation places the government and the industry in a piquant situation wherein, they need to work together, to ensure that the rich are not being subsidised for the poor.

It is also important to understand that, the industry alone cannot address access

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issues, if the access goes beyond pricing.

Pricing and accessibility are two pieces of a complex puzzle. Research-driven companies will continue doing, what they do best: innovate. They will continue collaborating with various stakeholders to broaden access to medicines among marginalised groups through shared value programs. The current ecosystem in India, unfortunately, is not conducive to innovation.

The ground reality is that, regardless of the number of patents granted, even after granting the patent, it is as good as ‘nullified.’ So you have Sutent of Pfizer and Pegasus of Roche, where both patents were revoked. Then, you have Nexavar from Bayer for which a patent was granted, and then a compulsory license was issued. The breakthrough cancer drug Glivec, hailed as one of the most innovative drugs, that changed the way cancer research is done, was denied a patent. While the absolute numbers may be small, the story they tell is large. They tell the story of a country that is not ready to encourage innovation, even 18 years after, it joined the World Trade Organization (WTO). They tell a story of a country that is mortgaging the future for the present.

India is home to some outstanding scientific expertise and this together, with excellent pharmaceutical manufacturing skills, will place us in an advantageous position. We have the potential to become a global leader in the development of new medicines, provided the innovation deficit is bridged.

Edit Associate - Products Rishab Kothari

Art Director Varuna Naik

Senior Designer Varghees Tharakan

Assistant Manager - Production Surekha Karmarkar

Senior Manager - Sales Olwin D’souza

Key Account Manager Darshan C Rampure

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Anniversary SPECIAL

News, views & analysis

Vercise™ DBS system from Boston Scientific for Parkinson’s ercise™ DBS (Deep Brain Stimulation) system from Boston howed Scientific Corp, showed significant improvement in motor nson’s scores of patients with Parkinson’s nterim disease according to an interim TAGE data, from the VANTAGE he six DBS study. Data from the month follow-up of up to 40 n the participants enrolled in sented VANTAGE trial were presented tional at the annual international congress of parkinson’s disease rs in and movement disorders Sydney, Australia by Prof Dr Lars Timmermann, University Hospital of Cologne, Germany The Vercise™ DBS system incorporates multiple

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independent current control, which is designed to selectively stimulate targeted areas in the brain, by providing physicians with fine control of stimulation.

Preliminary analysis of the VANTAGE study

displays approximately 60 per cent mean improvement in motor function at six months post implant, as assessed by Unified

Parkinson’s Disease Rating Scale (UPDRS) III1 when compared to baseline. Prof Dr Francois Alesch, professor for stereotactic stereota and functional neurosurgery, neurosurgery Medical University, Vienna Vienna, Austria and neurosurgical neur principa principal investig investigator of the tr trial said, “We aare pleased to se see such a sign significant improv improvement in motor fun function. I believe this unique technology, with its multiple current sources, may provide us with a more adaptable form of DBS therapy.

I was very pleased with the simple recharging system. All of my patients were able to recharge successfully.”

The Boston Scientific sponsored study was designed to document patient outcomes which include effectiveness, safety, and health economic data derived from bilateral stimulation of the Subthalamic Nucleus (STN) in the brain using the implantable Vercise™ DBS system for the treatment of levodopa-responsive, moderate to severe idiopathic Parkinson’s disease. 40 participants with Parkinson’s disease were implanted bilaterally at six European centres.

Abbott receives golden peacock award for global business excellence

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bbott, a major health care company in India, received Golden Peacock Global Business Excellence Award, 2013, at the recent ‘Global Convention on Business Excellence’ in Dubai.

This award recognises Abbott’s strong foundation of stakeholder engagement, a commitment to transparency, a workplace environment that enables employees to

achieve their greatest potential, high standards of ethics and compliance for the company and its partners, and the quality of its involvement with communities. It also recognises Abbott’s broader economic, social and environmental performance.

Speaking on the recognition, Bhaskar Iyer, Divisional Vice President India commercial operations, Abbott Established

Pharmaceuticals said, “Abbott is committed to advancing healthcare and improving the lives of millions of patients and customers by partnering with healthcare professionals, governments, nongovernmental organisations and other stakeholders. Being a responsible corporate citizen involves more than health care innovation and outreach.

Good citizenship also extends to the way we run our business

in a sustainable manner to benefit our stakeholders.”

The Golden Peacock global business excellence award was created by the Institute of Directors to encourage business excellence in both manufacturing, as well as service organisations globally. This category of award recognizes companies in areas such as leadership, vision, financial performance, managing risk and corporate sustainability.

Modern Pha rm a | 1-15 July 2013

In Brief

Indegene launches iAcademy Indegene, a scientific partner to global pharmaceutical and health care organisations has announced the launch of its learning and development academy, iAcademy.

As the global pharmaceutical industry continues to transform, it has become evident that the relentless pressures on R&D productivity, sales and marketing effectiveness, operational rigour and compliance will continue to drive reorganization and innovation initiatives. As the industry continues to evolve, the demand for specialised, scalable and reliable vendor partnerships is only expected to rise.

Manish Gupta, CEO, Indegene said, “We foresee these transformational changes as important opportunities for Indegene. iAcademy provides a sophisticated and predictable system for training and developing employees across all functional and domain areas that tie very closely with real changes in the marketplace. The primary benefactor of this initiative will be our clients, who will continue to gain access to our highly specialised and multi-skilled talent pool, as they continue to traverse this changing global landscape.”

News, views & analysis

Modern Pha rm a | 1-15 July 2013

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In-Sight® vision system guarantees perfect quality in pharmaceutical packaging

Venus Remedies receives patent for Potentox from Mexico

ost of the pharmaceutical products such as vials, clinical products, blister strips etc, for the small and medium-sized enterprises (SME) pharmaceutical and healthcare manufacturers are usually packed by external service providers.

It has been proven many times that the cost of using these services from the providers, sometimes prove to be unsustainable in the long run. And also there is the quality issue. To maintain the quality of products, it is essential or advisable that manufacturers have their own units, which will help them in producing large volumes and overcome high costs. The challenge is to drive down large-scale packaging costs for SME pharmaceutical product manufacturers.

The solution found, was to implement a fully automated, compact packaging process featuring an In-Sight® vision system to ensure the highest quality from highspeed production line. Knoll

enus Remedies Ltd, a researchbased global pharmaceutical company, has received another patent from Mexico for its novel antibiotic product, Potentox. The patent was granted by the Mexican Institute of Industrial Property (IMPI).This patent will protect the composition of Potentox.

The patent provides an exclusivity period for Potentox up to 2025. The drug is also protected by a number of other patents from various other countries, including USA, India, Australia, New Zealand, South Korea, South Africa, Canada and Ukraine.

Potentox is an Antibiotic Adjuvant Entity (AAE), a drug effective in case of hospitalacquired pneumonia and febrile neutropenia infections, primarily caused by quinolones or aminoglycoside-resistant microbes.

Clinical trials conducted for Potentox on more than 500 patients have indicated a drop in cost of therapy by 20-30 per cent as compared to conventional therapies.

Besides, studies conducted in hospitals across India have

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VpA GmbH of Hüttisheim, Germany has developed a fully automated, compact packaging process to meet this challenge.

Knoll’s automated Cognex In-Sight® vision system packaging system features production runs, as well as intelligent quality control vials and blisters. It enables using a Cognex In-Sight® p h a r m a c e u t i c a l and vision system. This system healthcare manufacturers was designed specifically to shape both hard and for SMEs but large soft packaging materials manufacturers can also use it, such as PVC/ALU or ALU/ to meet requirements during ALU, to fill and seal them high-demand periods. The and to produce blister system is easily movable p a c k formatsQuality because it is on rollers. This c o n t r o l is managed facilitates pharmaceutical entirely by the In-Sight® and healthcare packaging vision system, which within minimum space at checks the completeness maximum quality levels, of the packaged products at cycle rates of up to 45 as well as their shape units a minute and 40,000 and position to guarantee units per day in minimal perfect quality. Cognex operational space.

In-Sight® vision systems are Knoll’s compact blister self-contained, industrial packaging machine is grade vision systems suitable for c l i n i c a l that combine a library packaging o p e r a t i o n s , of advanced vision tools prototype p a c k a g i n g with high-speed image and s m a l l - t o - m e d i u m acquisition and processing.

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shown that Potentox is suitable for the treatment of infections caused by various resistant gram-negative pathogens in the Intensive Care Units (ICU).

Venus is upbeat about the response Potentox has received in the domestic and global markets. “The product is growing at a Compound Annual Growth Rate (CAGR) of 50 per cent since the past three years. To take this novel AAE to Mexico, the company is in talks with some pharmaceutical majors in Mexico for strategic tieups. The Common Technical Document (CTD) for Mexico is ready, and we will soon be filing it. But it will take us another two-three years to launch the product in this market,” said Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies Ltd. The global hospital-acquired bacterial infections market was estimated to be worth $ 9-billion in 2010. Potentox is designed to address the needs of almost 50 per cent of this market. The Hospital-Treated Infections (HTI) market is projected to grow at a rate of 2.7 per cent annually in major economies.

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Pfizer, GSK and Siemens form R&D consortium GATC Biotech offers world´s fizer Asia Pacific Pte Ltd, Glaxo Wellcome Manufacturing Pte Ltd and Siemens Pte Ltd have signed on as founding members of a new A*STAR R&D consortium programme. The innovative Processing of Specialties and Pharmaceuticals (iPSP) was launched by A*STAR’s Institute of Chemical Engineering and Sciences (ICES). This consortium will offer a platform for pharmaceutical and specialty chemical industry players to address various challenges such as costs, regulatory compliance, responsiveness in production and processes to bring drugs from trials to markets.

The consortium programme will bring together industry leaders, to address an increasingly urgent need to

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access emerging ‘next generation manufacturing’ technologies.

These technologies will provide quantum change improvements in cost, quality, environmental impact and process robustness in pharmaceutical manufacturing processes. The advancement in technologies and adoption of best practices in processing technologies will help companies boost productivity and maximise manpower development to maintain their competitive edge.

This programme will also offer members, a platform to interact, develop and grow the industry processing technology knowledge base by facilitating the technology transfer and manpower development, in advanced chemical processing technologies. The programme draws on established resources and capabilities at ICES, which include the Kilo Scale Laboratory, pilot-scale

multipurpose continuous plant, a fully equipped development laboratory and experienced staff for in-process development and operation. Chemicals and energy sectors are the key pillars in Singapore’s manufacturing output. This consortium will present tremendous opportunities for companies to extend their presence in Singapore and leverage on its position as a gateway to Asia. It also allows them to respond with agility to the emerging needs of Asian customers through innovation or customisation of new applications.

“ICES have built strong and deep capabilities in the understanding of process science and technologies. The time is ripe now, for such depth and breadth of knowledge to be applied to the chemicals and pharmaceutical industries. By identifying common research

focus, companies can mutually benefit from joint research. This will enable companies to address industry-wide challenges and further reinforce the competitiveness of Singapore’s chemicals industry,” said Dr Keith Carpenter, Executive Director, ICES. “At a time when companies in the pharmaceutical industry are challenged by speed in new product developments, manufacturing process innovation, consistency in product quality, regulatory conformance and environmental sustainability, an integrated approach to the application of cutting-edge technologies will be crucial to future success. The launch of iPSP is very timely,” said Lim Hock Heng, Managing Director of GlaxoSmithKline’s pharmaceutical manufacturing sites, Singapore.

fastest Exome sequencing service

ATC Biotech, the European leader for DNA sequencing, has designed InView™ 1-week Exome Diagnostic especially for diagnostic purposes. This service enables early detection of multiple genetic variants presumably responsible for diverse genetic disease markers within just 7 days, the world’s fastest turn-around time available.

With its DIN EN ISO/IEC 17025 certified next gen sequencing laboratories, GATC Biotech offers this application for detection of cancerous cells or early detection of other genetic diseases.

This application supports clinicians to initiate urgent treatments and opens up the way for more personalised patient care in the field of cancer, metabolic dysfunctions and immunological disorders. With a combination of standardised workflows and highest quality standards, InView™ 1-Week Exome Diagnostic is an overall solution for fast and reliable variant detection. Focussing on the functional relevant coding regions, approximately 1 per cent of the human genome (the Exome) needs to be sequenced. This provides an efficient advantage for diagnostics and clinical research.

“Next generation sequencing technologies have set a new level in the field of clinical research and diagnostics.

1-Week Exome Diagnostic is an all-in-one service delivering rapid results for early detection of diseases for our customers in diagnostics, clinical and pharmaceutical research,” said Dr Marcus Benz, COO, GATC Biotech. “Being the leading service provider for NGS solutions, scientists can profit from thorough experience in Exome analysis while receiving accurate results in only 7 days,” Benz added.

Essential requirements for the competence of analysis and calibration laboratories such as DIN EN ISO/ IEC 17025 and DIN EN ISO 9001 by the national accreditation body for the Federal Republic of Germany (DAkkS) have been fulfilled by GATC Biotech’s NGS laboratories.

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AbbVie takes Dr Reddy’s to court over Zemplar infringement S-based drug maker, AbbVie Inc takes Dr Reddy’s Lab (DRL) to court for allegedly infringing former’s patented drug, Zemplar on six counts concerning three patents.

According to reports, Dr Reddy’s Lab committed an act of infringement by filing an Abbreviated New Drug Application (ANDA) with a paragraph IV certification that seeks FDA-marketing approval for DRL generic versions of AbbVie’s paricalcitol injection products.

Dr Reddy’s filed an ANDA with the US Food and Drug Administration (USFDA), seeking approval to sell generic versions of AbbVie’s Zemplar (paricalcitol) injectable products in 2 microgram/ml and 5 microgram/ml formulations.

Dr Reddy’s Lab has stated that, Zemplar (paricalcitol) is a drug used for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.

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News, views & analysis Quintiles named ‘Best Place to Work in IT’ by Computerworld uintiles makes it to the list of ‘100 Best Places to Work in IT’ in IDG’s Computerworld for the fifth time.

“We are extremely honoured that Quintiles has been recognised by Computerworld once again,” said Richard Thomas, Chief Information Officer, Quintiles. “Quintiles works with leading biopharma and healthcare companies around the world, supporting them in their mission to improve health. We have been working over the years to create an environment where top technology talent has the opportunity to develop professionally, and make a difference in the lives of patients around the world.”

In late 2012, Thomas was named Computerworld’s ‘Premier IT Leader,’ which is a further indication of Quintiles’ position as the biopharma industry’s Information Technology (IT) leader.

Quintiles ranked sixth in the 2012 InformationWeek 500, an annual list of the top technology innovators in US.

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METTLER TOLEDO’s intelligent analytical measurement solutions reduce documentation burden harmaceutical production is among the world’s most regulated activities. Hence, creating and maintaining documentation in a quality control system to satisfy regulatory requirements is a considerable task for drug companies. Standard Operating Procedures (SOPs) are an essential component of most quality control systems and must document precisely all activities involved in drug production.

METTLER TOLEDO’s Intelligent Sensor Management (ISM®) is an innovative digital technology for analytical measurement solutions. ISM® improves sensor handling and increases process reliability with production uptime, leading to greater productivity.

It also simplifies sensor-related SOPs. Kurt Hiltbrunner, market specialist - pharmaceutical industry, METTLER TOLEDO explains with an example, “When a technician is calibrating a conventional analog pH probe, they must read the sensor’s serial number printed on the sensor body and update the history for that probe in their data, for example, the number of exposures to CIP / SIP cycles and operating hours.

They then need to decide, based on the sensor’s history, if the probe can be used again or should be disposed of.

ISM simplifies these operations as all relevant sensor data plus valuable sensor diagnostics data is stored on the sensor.

When an ISM sensor is connected to our iSense software, this information is automatically transferred to the software, which then updates its database for that particular probe. iSense also displays the sensor diagnostics, allowing technicians to easily see if any, maintenance the sensor requires or if it has reached the end of its reliable lifetime. ISM therefore not only simplifies sensor related SOPs by providing sensor diagnostics, but also increases process integrity.”

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Roselabs Bioscience invests ` 400 crore to set up PFS manufacturing facility oselabs Bioscience Ltd and Roselabs Polymers Ltd, a part of the Roselabs Group, have set up first-of-itskind complete end-to-end Pre-Filled Syringes (PFS) manufacturing facility in the world. The company has already invested more than ` 400 crore in this unique state-of-the-art facility near Ahmedabad. It is one of the few companies in the world to offer complete PFS solution under one roof: from manufacturing of glass and polymer PFS, to all components and developing formulations for injectables.

Roselabs has recently received approval from the WHO-GMP and has initiated the process of receiving regulatory approvals from other countries as well. The company is expecting to get regulatory approvals from 35-40 countries spread across South East Asia, Africa and Latin

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America in the months that follow for its new project.

Explaining the uniqueness of this new composite PFS set-up, Zameer Agarwal, Director, Roselabs Bioscience Ltd said, “Pre-Filled Syringe (PFS) is one of the most sophisticated medical devices in today’s world. There are only a handful of players in the world, who make either glass or polymer PFS, and they are dependent on a few other players for supply of other components.

In turn, these companies then supply complete empty PFS syringes to the pharmaceutical companies for the filling to done. The Unique Selling Proposition (USP) of Roselabs is that, it offers complete composite PFS solution under a single roof. The existing and potential market for pre-filled syringes in India and globally is huge. Nearly 95 per cent of PFS is imported into India, which is one of the fastest growing markets for this sector.”

Agarwal further added, “Roselabs is the only one-of-its-kind facility in India, which has commercialised 8 lanes for PFS filling, with dedicated individual lanes as per therapeutic segments like peptide, recombinant, hormones, biotech, ophthalmic and others, along with manufacturing of complete empty devices.”

The new state-of-the-art PFS facility at Ahmedabad has a capacity to manufacture 8 lakh syringes per day. The facility will also possess capabilities to manufacture both glass and polymer, Cyclic Olefin Copolymer (COC) syringes and formulation filling facilities too. The company will focus on making empty glass and polymer syringes, contract manufacturing, development of any formulation in PFS, development of customised drug delivery system and marketing formulations under its own brand name.

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Modern Pha rm a | 1-15 July 2013

Molecular analyses describes HIV epidemic in India Sanofi in race for Elder Pharma’s new doctoral thesis from Karolinska Institutet describes important properties of the HIV-1 subtype ‘C’ (HIV-1C) epidemic in India. HIV-1C is the fastest spreading viral subtype, which has infected most people around the world.

In his doctoral thesis, Ujjwal Neogi, doctoral student at Karolinska Institute’s Department of Medicine in Huddinge, has provided confirmation that India’s national AIDS programme has been a success.

“The molecular analyses presented in the thesis show that the epidemic has remained stable in India since 1990,” Neogi confirms. “The antiretroviral treatment worked for over 97 per cent of patients during a follow-up period of almost four years provided that, they had a good initial response and stuck to the prescribed regimen,” he added.

Neogi also studied the roots of HIV1C in India. The subtype was discovered

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in Ethiopia in the mid-1980s by a team of researchers led by Prof Anders Sönnerborg, who was Neogi’s principal supervisor. The DNA sequence of the virus has now been analysed in patient samples collected between 2007 and 2011. Using the genetic differences between different samples and the known rate of change of individual genes, Neogi calculated backwards and concluded that, today’s HIV-1C virus in India has developed from one or a few genetically related viral strains that arrived from South Africa in the early 1970s. Knowledge of the evolution of the virus, its origin and spread is essential for the future development of a strategy to deal with HIV-1C in India and other countries.

“One surprise was that over half of the young people with an HIV-1C infection have high levels not only of the virus but also of CD4+ T cells,” Neogi said. “They are well and show no

symptoms of AIDS despite high levels of the virus in the blood.”

The thesis also discusses several issues that can help to guide the control of HIV in India and other areas of limited resources, such as the possibility of using DNA instead of RNA during analyses for monitoring drug resistance and thus avoiding the need to keep samples in cold storage. It also described mutations linked to drug resistance in children, young people and adults, the significance of individual properties of the host for the development of drug resistance, and the expression of viral co-receptors in infants infected through the mother.

The study is the result of collaboration between Karolinska Institutet (Stockholm), St John’s Medical College Hospital (Bengaluru), the National Institute of Immunology (New Delhi) and the University of California (San Francisco).

domestic formulation business

harma majors such as Sanofi, Novartis and GSK are in the race to buy out domestic formulations business of Elder Pharmaceuticals. It is reported that Sanofi and GSK have put in nonbinding bids, while Novartis has signed a non-disclosure agreement.

Sanofi might have appointed HSBC as its investment banker. Elder Pharma has mandated Japanese investment bank, Nomura and consultancy firm, Ernst & Young to find a buyer through a negotiated transaction.

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Curie-Cancer and Sanofi collaborate for research on ovarian cancer anofi and the Curie Institute, through its Curie-Cancer partnership under the Institut Carnot label has entered into a three-year research collaboration to identify new therapeutic targets for the development of treatments for ovarian cancer.

The aim of this collaboration between Sanofi and Curie-Cancer is to revisit the basic biology of ovarian cancer through a translational research approach. The Institut Curie has a large collection of cryopreserved tumour samples that are well characterised clinically, histologically and biologically. These can be analysed to identify biological targets relevant to the effective treatment of certain types of cancer. Through this collaboration, Sanofi and Curie-Cancer expect to gain a better understanding of the molecular alterations that characterise many types of ovarian cancer, thereby enabling effective new drugs to be designed.

“We hope this type of long-term collaboration will ultimately open up perspectives for new therapeutic options for women with this disease.

It will combine the accumulated knowledge on ovarian cancer gathered over years by oncologists and biologists at the Institut Curie with the expertise of researchers from Sanofi’s research and product development teams,” said Dr Debasish Roychowdhury, Senior Vice President and Head, Sanofi Oncology. “It is currently hard to tackle ovarian cancer.

There are very few drugs available. We are very happy to collaborate with Sanofi to potentially provide our patients with additional therapeutic solutions. Sanofi’s expertise in the selection of therapeutic targets is complementary to the knowhow and technology platforms developed at the Institut Curie,” said Damien Salauze, Director, Curie-Cancer.

Using technology platforms developed at the Institut Curie with scientific teams led by Dr Xavier Sastre-Garau and Dr Sergio Roman-Roman, this research programme will make it possible to sequence molecules expressed by the tumour genome, compare the sequences of those obtained with non-tumour tissues from the same patients, then clarify and validate the nature of the molecular alterations that are identified.

Sanofi’s expertise in the selection of therapeutic targets will guide as an assessment of the tumour’s ability to be inhibited or stimulated by drugs.

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Silver can make antibiotics more effective iny amounts of silver added to antibiotics could make them 10 to 1,000 times more effective and enable them to fight drug-resistant infections, a new study has claimed.

Scientists at the Wyss Institute for Biologically Inspired Engineering at Harvard University found, treating bacteria with a silvercontaining compound boosted the efficacy of a broad range of widely- used antibiotics and helped them stop otherwise lethal infections in mice.

It also helped develop an antibiotic-resistant strain of bacteria sensitive to antibiotics

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again. It also expanded the power of an antibiotic called, vancomycin that is usually effective, only in killing pathogens called grampositive bacteria, such as Staph and Strep.

Silver allowed vancomycin for the first time to penetrate and kill Gram-negative bacteria, a group that includes microbes, which cause food poisoning and dangerous hospitalacquired infections. Silver also proved useful for two types of stubborn infections that usually require repeated rounds of antibiotic treatment and multiple visits to the clinic, “The results suggest that, silver could be incredibly

valuable as an adjunct to existing antibiotic treatments,” said Jim Collins, a pioneer of synthetic biology and core faculty member at the Wyss Institute.

In the study, researcher, Ruben Morones-Ramirez treated normal and mutant strains of Escherichia coli bacteria with a silver compound. Then, observed them under the electron microscope and ran a series of biochemical tests. Ramirez found that silver compounds cause bacteria to produce more reactive oxygen species, chemically reactive molecules that damage the bacterial cell’s DNA and enzymes, as well as the membrane that encloses the cell.

The results showed that, a small amount of silver made Escherichia coli (E-coli)

bacteria between 10 and 1000 times more sensitive to three commonly used antibiotics: gentamycin, ofloxacin and ampicillin. In mice, silver also helped antibiotics fight E-coli induced urinarytract infections. It allowed vancomycin to save the lives of 90 per cent of mice with life-threatening cases of peritonitis, an inflammation caused by infections of the abdomen surrounding the internal organs. Without silver, only 10 per cent of the mice survived.

The scientists also found that, the doses of silver needed to help antibiotics, did not harm cultured human cells.

This suggests that oral and injectable silver should be safe for humans as well. The study was published in Science Translational Medicine.

Modern Pha rm a | 1-15 July 2013

Hurdles in Indian pharma R&D midst raising concerns among US businesses and lawmakers over intellectual property protection in India, a new report says clinical trials, infrastructure and policy are the biggest obstacles in driving research and development innovation at a scale in India’s healthcare sector.

“While both global and Indian industry leaders opine, India’s Intellectual Property (IP) situation needs to be addressed and clarified, they have highlighted that in fact clinical trials, infrastructure and policy are the biggest obstacles for India to meet its potential of driving R&D innovation at scale,” according to the report titled ‘Crossing the next horizon: Will India play a meaningful role in global biopharma innovation?’

“The report clearly lays out the myths and facts about the biopharma innovation in India. The findings should help senior management of biopharma companies finetune their R&D strategy and help leverage India’s pockets of R&D strengths,” said Karun Rishi, President, US-India Chamber of Commerce. According to excerpts of the report, many global R&D heads and CEOs emphasise the need for Indian companies to shift from ‘deals’ that offer only cost arbitrage to alliances that focus on innovation, quality and service. The Indian healthcare sector has tripled in size during the last decade from $ 23-billion in 2002 to $ 70-billion today, but India continues to lag peer countries in spending, outcomes, health manpower and infrastructure. Within healthcare, the Indian pharma market has indicated strong growth from $ 6 billion in 2005 to $ 18-billion currently and is expected to grow to $ 45 billion by 2020.

“Discussions with several global and Indian industry leaders indicate a widespread acknowledgement of India’s potential for R&D innovation and while the fundamental drivers of the ‘India advantage’ exist, the opportunity has not played out as expected,” the report said.

The report recommends the Indian government to fix and clarify relevant policies and regulations around clinical trials and IP, focus on cross-border and cross-entity collaboration, while building on talent and infrastructure across clinical trials.

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Maharashtra Govt to cancel Johnson & Johnson’s Mulund facility licence aharashtra Government has upheld the Food & Drug Administration (FDA) commissioner’s move to cancel Johnson & Johnson India’s licence to manufacture cosmetics at its Mulund facility.

FDA’s move this year was based on limited number of batches of baby powder produced in 2007. In view of the state government’s decision, the Johnson & Johnson’s licence for its Mulund facility stands cancelled. The company will now have to close down its manufacturing facility at Mulund. The company has been involved into manufacturing of Johnson & Johnson baby powder, BandAid adhesive bandages and Stayfree sanitary napkins at the Mulund unit.

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News, views & analysis GVK BIO enters into drug repositioning collaboration with USFDA

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VK Biosciences (GVK BIO) has licensed its popular SAR, PK and Toxicity Database (GOSTAR) to the USFDA. The material transfer agreement forms the basis of collaboration in drug repositioning, wherein the initial focus is to identify alternative therapeutic indications of marketed compounds for neglected and orphan diseases.

GVK BIO developed a proprietary ‘Drug Repurposing Platform’ with eight different approaches to address the drug repurposing challenges. This platform will use data from GVKBIO proprietary databases such as SAR databases (GOSTAR), Biomarker database (GOBIOM) and other public databases.

Manni Kantipudi, CEO, GVK Biosciences said, “Drug repositioning is gaining traction in the industry and in academia. It is becoming a mandatory component of the drug development process. The GOSTAR product will prove valuable in allowing researchers to use multiple repositioning and repurposing approaches and address multiple targets in parallel.”

Sreeni Devidas, Vice President Business Development, GVK Biosciences said, “The collaboration with USFDA is a validation of the utility of GOSTAR in multiple applications. Specifically the Return on Investments (RoI) generated by the use in drug repositioning is unparalleled. GVK BIO will work with USFDA to further enhance the repositioning and repurposing workflow, and make it available to the entire research community.”

SC dismisses Ranbaxy’s PIL plea for allegedly manufacturing substandard drugs he Supreme Court has dismissed a Public Interest Litigation (PIL) seeking a probe against Ranbaxy Laboratories Ltd for allegedly manufacturing and selling substandard medicines.

A bench of jury, A K Patnaik and Ranjan Gogoi, allowed the petitioner advocate, M L Sharma to file a fresh petition, if some evidence is found against the company. The bench said that, it cannot decide on the plea against the company, on the basis of a judgement passed by US court against Ranbaxy.

“No material has been placed to show that drugs manufactured by any unit of Ranbaxy are substandard, adulterated or spurious,” the bench concluded.

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Micell Technologies receives CE Mark approval for MiStent SES® icell Technologies Inc, a partner company of Eurocor GmbH, received CE (Conformité Européenne) Mark approval for its MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) introducing a thin-strut stent that features elimination of the coating from the stent in 45-60 days and the complete absorption of the polymer coating within 90 days. The MiStent SES® is unique in providing local drug delivery both during and after the period of polymer absorption, thereby eliminating long-term polymer exposure, a potential cause of delayed healing and late adverse events.

Arthur J Benvenuto, CEO, Micell Technologies commented, “The MiStent

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SES® brings a new paradigm of safety without compromising on efficacy or deliverability. With polymer absorption faster than any other DES currently available, we believe the MiStent SES® provides a long-term safety profile of a highly deliverable bare metal stent.”

The MiStent SES® approval is supported by in-depth clinical analysis from the DESSOLVE I and DESSOLVE II clinical trials. The DESSOLVE II trial met its primary end point: superiority of MiStent SES in minimising in-stent late lumen loss (LLL) at nine months as compared to Medtronic’s Endeavor® Sprint DES. The trial was a randomised, multi-centre study of 184 patients with documented stable or unstable angina pectoris. At nine months’ follow-up,

in-stent LLL was 0.27 mm with a target lesion revascularisation rate of 0.9 per cent. The Major Adverse Cardiac Events (MACE) rates were 4.3 per cent for MiStent SES® and 6.7 per cent for Medtronic’s Endeavor®. In a sub-group of patients, Optical Coherence Tomography (OCT) and endothelial function testing confirmed good vessel healing with excellent strut coverage and normal endothelial function.

With this CE Mark approval, Micell is preparing to make the MiStent SES® commercially available in Europe and other markets, where CE Mark approval can expedite the registration process. The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System is not currently available for sale in any market.

Arvind Remedies to set up ` 2.5 billion manufacturing facility

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rvind Remedies plans to set up ` 2.5 billion manufacturing facility at Irungattukottai, near Chennai.

“The company will seek USFDA

approval in six months. The US pharma industry is currently estimated at $ 326 billion,” said B Arvind Shah, MD and CEO, Arvind Remedies. The company has further set

up a subsidiary in New Jersey to take care of its US business. Last year, the company clocked a turnover of ` 704 crore, with a net profit of ` 41 crore.

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First national biomedical engineering training programme at Bengaluru he city of Bengaluru eagerly awaits the commencement of a week-long biomedical engineering training programme to be hosted by Trimedx and Narayana Health with technical support from PGIMER (Chandigarh), SCTIMST (Trivandrum), HTIC-IIT(Madras), Medica Synergie (Kolkata), Era’s Medical College and Hospital (Lucknow). The programme is slated to begin on 8th July, 2013 and will be held at Narayana Hrudayalaya Health City, Bengaluru.

Today many small hospitals, nursing homes and clinics perform ‘B’ and ‘C’ types of minor surgery procedures commonly.

Emphasising on the need for a nationally accredited and certified biomedical training programme, Mohammad Ameel, Head-Biomedical Engineer, Era’s Medical College & Hospital (Lucknow) said, “Such hospitals generally utilise the services of a trained engineer (usually a diploma holder) who may have specialised in electrical or mechanical engineering, but not necessarily

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biomedical engineering.” Hence, they lack technical knowledge and expertise.

With a shift observed in the hospitals moving towards specialised offerings over generalised services, the cost involved in recruiting a trained biomedical engineer with skills and expertise is not always affordable. To bridge this growing need, a team from across the country met and collectively deliberated on solutions to resolve this crisis on 11 February, 2013.

As an the outcome of the discussion held, the Bengaluru training programme to be organised exemplifies the efforts

involved. The training programme received overwhelming responses from different faculties across the industry on social networking platforms, with many expressing keen interest to pre-register.

Ameel further explains the benefits of the training programme and said, “The training will generate quality professionals who can handle basic equipment maintenance and management at institutional level.

The trainees will be provided technology demonstration and will be given component level servicing, calibration and maintenance.

This would even facilitate establishment of training laboratories for partner institutions across the country, which can be utilised by upcoming biomedical engineers of the region.”

This training will include hands-on experience on the technology components, field visits to neighbouring hospitals or equipment in-service at the host institution’s hospital, administrative and documentation training that include making of purchase orders, contracts of AMCs/CMCs,

equipment audit, profiling and equipment safety. The registered trainees shall be provided certificate on completion of the week-long programme.

Long-term vision of the programme aims at training and creating a mass scientific market of expert biomedical engineers in the country, which will help resolve redundancy issues particularly in the public health sector. In a short span of time, this programme aims at achieving the targeted objective of enabling practical biomedical engineering training to small hospital and nursing homes irrespective of their type. This will improve safety, reliability and quality of care to patients through good maintenance and proper technology management. However, this being a nonacademic technical training programme at the national level, the course hopes to be empanelled by National Education Board for Education and Training (NABET) and Quality Council of India.

Anubhav Sharma

Health Ministry bans 3 widely prescribed drugs in India he Ministry of Health and Family Welfare recently, banned the sale of three widely prescribed drugs in India. Antidiabetic Pioglitazone, painkiller Analgin and anti-depressant Deanxit drugs were banned owing to increases in reporting of adverse health-related cases. According to the drugs and cosmetics law, any drug that is banned in the country of origin will be prohibited for sale in India until proven to be harmless Health ministry has been mulling on the withdrawal of these drugs since years.

According to reports, these drugs aren’t marketed globally. All major countries such as US, UK, Canada, Japan, European Union and Australia have already banned the drugs. Analgin is the trade name for metamizole, or dipyrone, which is an analgesic and antipyretic. The drug was available worldwide until the 1970s, when it was discovered that the drug carries a small risk of causing agranulocytosis, a potentially fatal condition. Several national medical authorities have since withdrawn, metamizole from the market altogether or have restricted its availablility only with a prescription. However, the drug still remains available over the counter in many countries. It has a small market in India and is marketed by Sanofi Aventis and Baralgan.

Pioglitazone is used to treat diabetes. It is a prescription drug of the class thiazolidinedione (TZD) with hypoglycemic (antihyperglycemic, antidiabetic) action to treat diabetes.

Pioglitazone has found to be associated with bladder tumours and has been withdrawn from some countries. This drug has ` 700-crore market in India. The ban will affect Ranbaxy, Abbott, Wockhardt and Sun Pharma.

Produced by Danish Lundbeck, Deanxit is the trade name for flupentixol/melitracen, which is essentially a combination of two psychoactive agents. It is banned in India and its country of origin, Denmark.

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News, views & analysis

Modern Pha rm a | 1-15 July 2013

Ranbaxy, Daiichi to leverage on brand strength for global markets n a bid to strengthen their hybrid business model, drug major, Ranbaxy Laboratories and its parent firm, Daiichi Sankyo have decided to project only one of them as the face of the group in different global markets, depending on their respective strengths.

“On the front end, depending on the markets whichever company has the strength will be the face of the market,” said Arun Sawhney, CEO and Managing Director, Ranbaxy.

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As per the company’s hybrid business model, Ranbaxy primarily will focus on generic drug research both for itself and its parent firm, while the new drug discovery programme is undertaken by Daiichi Sankyo.

Sawhney elaborated, “For example, in India, even the future Daiichi pipeline products will come through Ranbaxy and in Japan, Ranbaxy’s generic products will be taken to the Japanese market by Daiichi Sankyo. So, we will leverage the strengths of each company

to grow the businesses of both the companies.”

The two firms will synergise across each segment of pharmaceutical value chain starting from R&D, sourcing, manufacturing, distribution, sales and marketing.

Ranbaxy will synergise with Daiichi Sankyo’s back-end development, distribution and sourcing to strengthen both the companies, so there will be synergies across the value chain areas of co-operation identified.

“Under the hybrid business

model, we will be leveraging the strengths of both the companies.

So, benefits will accrue to Ranbaxy and benefits will also accrue to Daiichi Sankyo,” Sawhney said. The companies are currently leveraging their strengths in various countries, including Brazil, Mexico, Thailand, Venezuela, Romania, Italy and Kenya among others.

Ranbaxy became a part of the Daiichi Sankyo Group in 2008, after the Japan’s third-largest drug maker bought a majority stake for ` 22,000 crore.

Pharma industry grows by 7 per cent to ` 6,370 crore in May’13 espite weak market conditions, the domestic pharmaceutical market reported growth of 6.8 per cent at ` 6,370 crore for the month of May 2013, IMS Health report stated. For the 12-month period ended May 2013, the pharmaceutical market was reported at ` 74,117 crore, with a growth of 10 per cent, over the same period last year.

“The pharma market reported total sales of ` 6,370 crore in the month of May 2013, while registering a growth of 6.8 per cent in the previous year.

However, we have seen a slight dip in the market as compared to

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the previous month. The market reported sales of ` 6,744 crore, a growth of 13.9 per cent in April 2013,” Kumar Hinduja, Senior Director - Strategy Planning, Business Development, Pharma & Payer Solutions, IMS Health said. Though traditionally, the market in May was relatively weak in comparison to April, on account of summer vacations and the prevalent heat conditions, we believe that some market factors have further dampened sales uptake in May, this year.

“One factor was the apprehension in the trade on the imminent implementation of Drug Price Control Order (DPCO) 2013, and its implication

on the, business, including recall / re-labelling of formulations, which would undergo price revisions.” Hinduja explained.

Uncertainty around this appears to have prompted majority of dealers to maintain lower inventory levels of drugs during the month - both at retail as well as stockist levels. For the same reasons, trade schemes which generally induce higher uptake of goods, were almost absent in the market, this May.” For the month of May 2013, Cipla recorded sales of ` 302 crore, Sun Pharma of ` 297 crore, Alkem with ` 222 crore and Sanofi ` 186 crore sales were the fastest growing corporations

among the top 10 companies.

The month of May witnessed local companies registering stronger growth at 7.4 per cent, while MNC pharma companies grew at 5.3 per cent. The top 10 companies with a combined share of 40.5 per cent grew at 4.3 per cent for the month of May. Anti-diabetics were the fastest growing therapy for the month of May 2013 at 18 per cent, followed by dermatology at 13.3 per cent and cardiac drugs at 11.2 per cent. Chronic therapies continue to show stronger growth for the month underlining the growing penetration of these disease conditions in the Indian population.

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In Brief

Merck gets interim relief from HC The Delhi High Court has restrained Aprica Pharmaceuticals Pvt Ltd, an Indian pharmaceutical company from launching its diabetes drug, for allegedly having identical molecules and derivative salt of the patented drug manufactured

by US drugmaker, Merck Sharp and Dohme Corporation (MSD).

The ex-parte interim order was passed on the lawsuit filed by MSD, seeking to restrain domestic firm, Aprica Pharma from manufacturing and promoting its diabetes drug.

The US pharma major alleged that the Indian company was soon launching the diabetes drug, with Sitagliptin molecule and its derivatives salt, in which it has registered patent right.

MSD claims to hold an Indian patent on Sitagliptin, a chemical compound sold under the Januvia and Janumet brands used to treat type 2-diabetes.

Justice Sanjeev Sachdeva said, “I am of the view that in case ex-parte injunction is not granted to the plaintiff (MSD) and defendant (Aprica) is able to launch the product, irreparable loss and injury will be caused to the plaintiff which cannot be compensated in terms of money.”

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Indian pharma in 2020

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Nikunj Sharma nikunj.kumar@network18publishing.com

Regulatory challenges

Need to balance growth with compliance Growth trajectory of the pharma sector is vectored by several issues such as generics war, fair clinical trials, pricing, export regulations and drug safety. The real challenge for the regulators is to maintain a balance through strict and positive regulatory environment, while ensuring effective compliance to the standards. y 2020, the Indian pharma sector will be a multibillion dollar industry, characterised by huge growth potential. The ‘Pharma Vision 2020’ document from the Department of Pharmaceuticals (DoP) incor p orates Indian governments’ initiative to position the country among the most soughtafter destinations for uninterrupted novel drug discovery.

Visualising this, the government is offering help in terms of globally competitive workforce, best-inclass infrastructure for research in pharma and venture fund to boost R&D activities in both private and public sectors. But it is essential that the regulatory regime governing the sector would facilitate the realisation of the potential that is inherent to its strength and positives.

Dr Monica Gulati, Senior Dean, Lovely Professional University states, “As of now, there are many issues, which the players consider as regressive in nature, and call upon the government to address the same in the better interest of the industry as well as the players featuring in it. Pricing of products is an important issue, regulated by the state authorities, with

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Q&A with How do you visualise the future of pharma in India?

Future growth of the pharma industry in India is expected to come from export of generics and biotech products to regulated markets. India with its vast and diverse scientific human resource, diverse patient population for clinical trials, has got tremendous potential to be the global hub for discovery of new drugs to provide cost-effective quality medicines to the world. Multinational pharma companies certainly find India as an attractive investment destination for drug discovery research in addition to manufacture of generics. India will be the global pharma hub in the next decade or two.

various clamouring voices dotting the scene. National Pharmaceutical Pricing Policy has been framed, which will address issues regarding pricing of scheduled drugs ie, drugs with a market share of more than 50 per cent. Pharma companies subjected to such regulations have reservations regarding some of the regulations, stating that the provisions are discriminatory in nature and curbing their potential to grow.”

The Indian pharmaceutical industry has head on competition with the Chinese pharmaceutical sector, which offers lower cost of production comparatively. While, Indian drugs possess an edge over quality, the Chinese market enjoys better recognition as in comparison to India. The Drug Price Control Act, which was set up for the benefit of consumers poses challenges for the drug producers, due to escalating raw material costs.

Additionally, issues like skilled and unskilled workforce in the manufacturing hubs pose major problem for the companies. The vision document targets to place India among the top five major pharmaceutical innovation centers by 2020.

“The other area that poses regulatory challenge is the prevalence of counterfeit and spurious drugs.

Then there are provisions stipulated by the law of land, but the menace is as threatening as ever. Other issue that will be regulated in a more vibrant manner in the times to come, is the nexus between drug makers and medical practitioners. With an intent to make larger than ordinary profits, some firms develop nexus with medical practitioners, thereby bringing down competition by unfair practices. This does have a detrimental effect not only on the naive players but also results in higher cost of drugs to the patients.

Regulations related to the quality of drugs manufactured will also be one of the key regulatory challenges for the g ov e r n m e nt with proliferation in the number of manufacturers making quality assurances, is becoming a tedious task,” Dr Gulati emphasised.

Key takeaway points Venture fund to boost R&D efforts Chinese pharma sector offers low production cost

To make large profits, some firms develop nexus with medical practitioners, thereby bringing down competition by unfair practices.

Dr Monica Gulati Senior Dean, Lovely Professional University

Regulatory challenges for government India to become a novel drug delivery destination in future.

Dr Ganesh Prasad Chief Executive Officer, Q Pharma Consulting India What are the concern areas that need to be addressed on an urgent basis?

Although Indian pharma industry has made significant dent in the global markets, both regulated and non-regulated, ‘quality’ still remains a primary concern. It is estimated that nearly 30 per cent of the spurious or misbranded drugs in the global market has its origin in India. In my opinion, most of the pharma companies are ‘compliance’ driven rather than being focused on ‘quality’ and ‘manufacturing efficiency’. This has to change. Quality surveillance from drug agencies in the regulated markets will be a major challenge in

the near future. Domestic regulation has to undergo significant change in terms of regulatory structure and implementation towards achieving global regulatory standards.

Do you think government is overprotective about the industry and generic brands?

I don’t think so. Indian patent laws have always been rightly framed bearing on mind the interest of Indian population. Recent changes in the patent laws allow protection of product patent. This should trigger further growth of contract research, clinical research organisations and generics manufacturing as well.

What measures do you suggest to conduct fair clinical trials in India?

India provides an attractive platform for conducting clinical trials towards discovery of new drugs. Good Clinical Practices (GCP) is already a part of the Indian drug law.

Rigorous implementation of GCP and probably more transparency in the system of conducting and regulating clinical trials, systems to ensure prevention of conflict of interests within the ethics committee and focussed efforts to bring in patient awareness should lead to fairer clinical trials.

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Anubhav Sharma anubhav.sharma @network18publishing.com

Pharma manufacturing

Redefining operations by effective GMP compliance Indian pharmaceutical companies would like to grab a larger market share by foraying into western markets through world-class products manufactured at reasonable prices. However, this long-sighted goal remains far from accomplishment without effectively meeting the GMP compliance norms, set as per international standards. ndia today, ranks as the topmost producer of generic drugs, at par with Brazil. While patent drugs manufactured in India are also being well-recognised in international markets. This entire process chain draws attention at the core, to the need for effective Good Manufacturing Practices (GMP) compliance.

The processes involved in production of safe drugs will decide the output quality and thereby promote safe drug usage and delivery across markets on a global paradigm as well.

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Current GMP standard The GMP standard of India is mentioned in Schedule M of the Drug and Cosmetic Act, 1940. Amendments were made later and the GMP standard became applicable from July 2005.

Atul Shirgaonkar, CEO, Insight Systems Inc, says, “This is no less than an international standard and all manufacturers are required to comply with the same. Sufficient time was provided for implementation and thereafter in November, 2010 Schedule L1 Good Laboratory Practice (GLP) was added to bring the labs in the ambit of good practices.”

As recently, many activities have raised eyebrows on the GMP practices followed by Indian pharmaceutical manufacturing companies. These have

Q&A with

How can India achieve effective GMP? In India, medicines constitute the major chunk of healthcare expenses which escalates as high as 70 per cent.

With universal healthcare policies and ‘Free medicine schemes,’ the proportion of people having access to medicines will certainly increase from the current 35-40 per cent of the population to eventually cover 80 per cent of the population. These kinds of policies will lead to challenging opportunities. The cost has to be brought down and the quality has to go up. Else, there will be more deaths due

raised an alarm for new regulations, which will evolve GMP practices in the years to come. , “If you look at the growth of the pharmaceutical manufacturing industry in India, exports particularly of API and certain formulations, the international inspections have led to the evolution and implementation of increasing global GMP requirements and will continue to do so,” Shirgaonkar expresses hope. In cases, wherein companies fail to comply with the global GMP requirements, it reflects in the quality of products manufactured.

The path forward for top pharmaceutical giants is focussed on meeting the USFDA, EU and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) requirements. Shirgaonkar further adds, “We have already witnessed certain addition to Indian standards in terms of guidelines for recall and good storage and distribution practices, which appear to be growing at a slow pace. It is required to speed-up the introduction of new and increased requirements to maintain pace with the global quality standards and to bring in desired improvements. These steps will help us emerge as world leaders by 2020.”

Envisioning tomorrow There are various challenges envisioned for the Indian pharmaceutical industry

going forward and hence it is crucial to meet the global GMP requirements.

With strict adherence to GMP requirements, it will boost the product quality during manufacture. “It is time that our standards are revised such that commonality is achieved. Keeping the employees up to date with the current requirements and trends, continued effective training, encouragement and support for implementation of standards and building continuous awareness amongst the manufacturers is the key to growth,” Shirgaonkar adds.

Targeting GMP To manufacture a globally acceptable product, a company has to meet the global requirement of GMP. Without which, companies cannot expand reach into global markets and growth of pharma manufacturing industry can remain a far-fetched dream. Getting in sync with the current market trends and developing products by paying attention to quality at all times, in strict compliance to GMP norms lies our success secret.

Key takeaway points Need for effective GMP compliance to ensure quality drugs Good storage and distribution practices to accelerate industry growth

If you look at the growth of the pharmaceutical manufacturing industry in India, exports particularly of API and certain formulations, the international inspections have led to the evolution and implementation of increasing global GMP requirements.

Atul Shirgaonkar Chief Executive Officer, Insight Systems Inc

In November, 2010, Schedule L1 Good Laboratory Practice (GLP) was added to bring the labs in the ambit of good practices

Rajendra Pratap Gupta International Healthcare Policy Expert & President, Disease Management Association of India to medicines than without medicines.

With recent unfortunate happenings coming to light in terms of quality of medicines and regulatory procedures, it will create a ‘crisis of perception’ for Indian manufacturers, international community and prescribing doctors.

Third party manufacturing is an area that must be carefully watched out for SME’s.

As we move along the export path due to globalisation and postpatent opportunities, there will be harmonisation in GMP, in the context of global trade and also the standards that are unavoidable. This

will open up avenues to engage with the international regulators and set benchmarks to keep India at par with the global GMP standards.

So India needs to move from GMP to gGMP (Global GMP) for pharma manufacturing.

What kind of changes do you foresee in the GMP rules in 2020?

In the years to come, the Indian pharmaceutical manufacturing space will witness change from the ‘fight for price to the fight of the quality.’ This will further lead to many more consequent changes

that will help the industry achieve the gGMP goal.

How has recent industry happenings contributed to the evolution of GMP in India?

The recent incidences are sort of wake up calls for the industry. The industry as a whole has started responding to this alarming change with a shift observed from price to the quality of the product. While at one point, the industry needs to join forces and take to self regulation standards, on the other, the regulators need to become more vigilant and proactive for betterment of the industry and users alike.

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Nikunj Sharma nikunj.kumar@network18publishing.com

Pharma packaging

Technology as the key leverage Pharmaceutical packaging has evolved with the times and helped every stakeholder involved, right from the supplier to end consumer, by incorporating user-friendly security features that offer instant tracking and tracing. This also ensures authentication and reliable product delivery. harmaceutical packaging helps maintain integrity of the formulation by providing protection, identification and information through all stages of transportation, handling and storage.

Pharma products encounter several challenges through the supply chain.

Apart from possible physical damages due to temperature, humidity, moisture, compression etc, the other challenges related to counterfeiting, tampering and pilfering are increasingly gaining notoriety.

Comparing the recent advances in packaging with the conventional packaging techniques, Neeraj Vashisht, Senior Principal Consulting, IMS Health, opines, “Traditional environment inflicted threats have being countered by technological innovations in packaging materials. For eg, innovations in polymer and foil based packaging films are minimising damages caused due to environmental factors. They also provide tamper-proof packaging which is mandated by most regulatory bodies across the world. With a sharp rise in the number of confiscated counterfeit medicines in the recent times, ‘Track and Trace’ enabled packaging is being increasingly adopted by many players of packaging technologies. These methods provide unique identifying codes on each product, such that post-packaging, each item is easily traceable throughout the supply chain. Technologies like

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Q&A with How will you interpret the transformation of pharma packaging from just a simple pack to an indispensable safety tool?

Today, the packaging involves several features to protect itself from duplication. The covert characteristics are not visible to a common consumer but a manufacturer can easily detect them. Overt features are visible and serve to assure the genuineness of a product. Generally more than one complementing solution is deployed to secure a package. Interactive solutions encourage consumers to verify security codes on packs through SMS or call center, giving instant information on fakes, if any. This is actionable intelligence from the market and brand

Radio Frequency Identification (RFID), labels with DNA or chemical markets, branded holograms are being actively recommended and extensively utilised.”

According to a review article by Zadbuke N, Shahi S, Gulecha B, Padalkar A and Thube M titled as Recent trends and future of pharmaceutical packaging technology, published in J Pharm Bioall Sci 2013; 5: 98-110, stated that, India’s pharmaceutical packaging sector is registering an annual growth rate of around 5 per cent with an estimated value of more than $ 20 billion per annum.

Any pharmaceutical pack must adhere to the quality, security, tamper resistant and product safety compliances. Continuous advancements in pharma technology like unit dose vials, BFS (blow fill seal) vials, snap off ampoules, anti-counterfeit measures, prefilled syringes, Plasma Impulse Chemical Vapour Deposition (PICVD) coating technology, two-in-one prefilled vial design and child-resistant packs have added value to drug packaging solutions.

The future implication of pharmaceutical advances reviled around innovative label designs, counterfeiting, patient compliance, product recalling, sustainable packaging, serialisation and relevant regulatory environment.

Apart from that, the packaging sector will also focus on strategies to combat counterfeiting, decreasing ecological footprints, ensuring packaging

sustainability, novelty in multilingual labeling and packaging, communicating effective drug information, while discovering new techniques and measures for efficient patient compliance.

Recognising the impact of advancements in pharmaceutical packaging, Vashisht added, “RFID technology in particular offers companies, many advantages especially in the light of the demands posed by international delivery chains. RFID makes it possible to identify drugs quickly and reliably at each point of the supply chain, from factory to consumers, checking counterfeiting as well as helps protect the value of the brand. Packaging is playing an important role in the fast emerging field of biotech products where around 45 per cent of new drug approvals contain biotechnological components. With 90 per cent of these drugs being packaged as liquids, packaging techniques have evolved significantly to safeguard these products throughout their long shelf-life, while enabling ready and accurate use whenever required. Track and Trace technologies are especially useful in case of these expensive drugs.”

Key takeaway points Sharp rise in number of confiscated counterfeit medicines Increasing adoption of ‘Track and Trace’ technology by industry players

With a sharp rise in the number of confiscated counterfeit medicines in the recent times, ‘Track and Trace’ enabled packaging is being increasingly adopted by many players in packaging technology.

Neeraj Vashisht Senior Principal Consulting, IMS Health

India’s pharmaceutical packaging sector registers annual growth rate of around 5 per cent per annum Decreasing ecological footprints

Kishore Kar Senior VP, India & South East Asia, PharmaSecure

manager can take appropriate steps to ensure safe medicines.

Do you see only technology-based innovation as a tool to ensure safe drug supply?

Technology based innovations are raising the bar for counterfeiters. Every time there is a loophole detected, an enhanced version of technology is released in a short span of time to curb counterfeiters. Security of information flow along with the shipment is proving to be crucial in ensuring supply chain safety. Most recent developments and regulations focus on Track and Trace, e-pedigree etc, which are great initiatives. PharmaSecure has already deployed its SMS based verification

service for more than 50 crore packages in India and Nigeria, which is proving to be highly effective.

Will packaging be given utmost priority in the journey towards pharma 2020?

Packaging will play a crucial role as in this case. PharmaSecure through its several value added services such as serialisation solution, ensure safe medicines and facilitate smarter patient engagement services for doctors. Even adherence and compliance issues are addressed with active participation from patients to offer health tips, refill reminders and dosage reminders. These are new value added services in offering for the pharma industry.

Kindly elaborate on scope for improvisation of key targeted features to maintain and leverage pharma packaging.

Serialisation has been found to be the most cost-effective and scalable solution for pharma industry globally. It facilitates interoperability in adherence to global standards without complicating requirements, through a pragmatic approach that manufacturers can comply. Most countries have started mandating these requirements, some with more stringent norms over others.

However, the key lies in starting off with the process and ensuring practical timelines are set at each stage.

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Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Legal battles

Patents vs generics: Who will rule?

India being a progressing economy, product innovations attract very few investments from the industry players.

Increasing costs of drug development are a mammoth hindrance for countries like India. Being a leader in reverse engineering innovator drugs, India has made a definitive mark for itself in the global healthcare market. ith niche markets such as biologics, biopharmaceuticals and contract research gaining momentum, and their patents expiring in the next few years, pharma players are taking keen interest in the generics segment. Moving up the value chain would require Indian pharma companies to upgrade their profiles in the international market.

USA and Europe is also dispensing a good number of generic drugs to the patients. However, there seems to be an urgent need in the west to shift focus back to research.

Between 1995 and 2013, the Intellectual Property Rights (IPR)/ patent river has been flowing turbulently enough. The ‘doomsday omens and prophecies’ by pharma pundits have been proved wrongtill now. Early grant of product patents, post-2005 did result in extensive, often frivolous infringement suits, injunctions, counter claims and revocations. Other than the section 3(d) litigations, majority of suits and writ petitions were relating to patent-regulatory linkages. Despite early settlement by the Delhi High Court and the Supreme Court, the legal battle continues to be dragging on in various courts, owing to adjournments. ‘Patent is valid, but not infringed’ judgements are under appeal by both sides. Frivolous

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Q&A with

How do you visualise the outcome of the patent vs generics war in India?

The entire world market is moving towards generics. Even in US over 75 per cent prescriptions in the year 2012 were for generics. However, patents and generics are two sides of the same coin.

Only when someone discovers a new molecule, patents it and when the patent expires, it becomes generic. Unfortunately in India, even valid patents have been infringed through compulsory licensing because of ambiguous criteria like ‘not worked in India’ or ‘affordability.’ This is an unhealthy trend which will certainly impact innovation and investment in research.

litigations on incremental innovations, between Indian pharma companies are mostly driven by ‘market-share’ egotrips are also increasing.

To predict the pharma scenario in India in 2020 with specific reference to patented molecules and dosage forms vis-à-vis generics is no tall order. Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, opines, “Generics are here to stay and will continue to be in the pink of health in 2020 too. By 2020, the early challenges to patented molecules viz, New Chemical Entity (NCE) will substantially diminish.

However, licensing of patented molecules to Indian domestic companies (often more than one) will increase substantially, thereby extending the early reach of advanced ‘life saving’ and ‘quality of life’ medications to a wider cross-section of the needy community.

It is predicted that the pharma patent litigations will come down in days to come by 2020. There will be 3 types of pharma patent litigations raging in India - NGO-driven, greed-driven and ego-driven. NGO and generics driven litigations will continue to be related to lack of affordable access, non-working, government use and compulsory licenses.

The greeddriven litigations will continue to be driven by evergreening intentions despite section 3(d), especially since

the new drug pipeline is drying out.

Litigations against Indian born NCEs and dosage forms are unlikely in 2020 or thereafter, because issues like Form 27, non-working, not manufactured in the country, unreasonable price etc, are unlikely to come to play in such patents.”

“If the current trend is to be extrapolated, the third category of egodriven patent litigations is expected to increase by 2020. These litigations will follow the path of ‘mother of all ego-driven pharma patent litigations’ ie, the ‘Gleevec’ patent battle. Egodriven litigations in pharma patents are most likely to be played between Indian generic companies than between MNCs and Indian companies. MNC patent wars are mostly in the second category of greed-driven litigations. The segmentwise leadership issues, market share disputes, infringement of incremental innovations, disputes on confidentiality violations (due to migration of resources and IP stakeholders) are likely to be drivers for such pharma litigations in 2020,” Nair reiterates.

Key takeaway points Pharma industry shifting focus towards generics New drug pipeline is drying out

Generics are here to stay and will continue to be in the pink of health in 2020 too. By 2020, the early challenges to patented molecules viz, New Chemical Entity (NCE) will substantially diminish.

Dr Gopakumar G Nair CEO, Gopakumar Nair Associates

Confidentiality violations Frivolous litigations on incremental innovations

Dr Ajit Dangi President and CEO, Danssen Consulting Will India remain the largest generics producer by 2020?

For India to become a world leader in generics by 2020, it is dependent on three factors – perception about the quality of Indian generics due to recent developments, consistent and stable government policies and global healthcare reforms. India also needs to capitalise on the immense opportunity arising in the biosimilar space. China has taken over India both in biosimilars as well as APIs. Associations are helping accelerate India’s generic exports by proactively interacting with overseas governments and negotiating export friendly policies.

Do you think the race for generics will hamper innovation in drug development in India?

Increasing use of generics is a key strategy for developed countries to contain burgeoning healthcare costs. As long as the intellectual property of the discoverer is honoured, there is no need to worry about the impact of generics on innovation. However, this trend will certainly influence business models of research based pharmaceutical companies. More and more companies are likely to resort to a hybrid model of having both patented as well as branded generics in their portfolio, particularly because pharmaceutical research is increasingly becoming risky, expensive and lengthy.

Additionally, many blockbusters are nearing their patent expiry and research pipelines are increasingly getting constricted.

How will the recent developments impact Indian pharma industry?

The recent developments will act as a deterrent for investment in innovation and research not only for MNCs but for research-based Indian companies as well.

The investment will shift focus to countries wherein there exists sound ecosystem for innovation and good enforcement of Intellectual Property Right (IPR) laws in letter as well as in spirit. Countries like China, Singapore and Korea significantly attract more FDI in pharmaceuticals over India.

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Anubhav Sharma anubhav.sharma @network18publishing.com

Clinical trials and research

Collaborate to reform drug cannot get clearance from regulatory bodies without a positive clinical trial. A clinical trial on the drug helps determine the effects and side-effects if any, on the human body. Therefore, regular clinical trials are an utmost necessity. On successful completion of clinical trials on drugs, it is then available for distribution and consumption by the masses at large.

However, if the results of the clinical trial turn out to be negative, then such drugs are banned.

With the global pharmaceutical market growing at a rapid pace, better controlled clinical trials is much in demand. Shedding light on the myths and issues impacting the fair processing of clinical trials, we take you through the current issues faced by this sector and future trends in the years to come.

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Government regulation To prevent human losses during the process of clinical trials, the Indian government has established strict norms, which at times act as hurdles to growth. According to Nidhi Saxena, Founder, Chairman and CEO, Karmic Lifesciences, “The clinical trial market has been adversely affected by the current government norms as well as some of the concerns around subject deaths, subject compensation and illegal clinical trials.”

Q&A with

How can clinical trials be easily regulated?

Modern clinical trials require industry to adopt risk-based approach. Several initiatives are currently underway, which will significantly impact the industry especially study startup, monitoring, and closeout. Industry and regulators have joined forces to identify means to reduce the cost of running studies while maintaining compliance and quality. Also reduced source document verification, centralised and aggregated data monitoring and electronic clinical systems for data capture will take centre stage soon. In the near future, we will see greater reliance on data analytics.

The recent incidences have hugely impacted the clinical research market in India. Herein, we decode myths and elaborate on the efforts made towards fair processing of clinical trials in India.

These norms have impacted the clinical trial market badly and it has gone down by almost 20 to 30 per cent.

Further to this, several multinationals and global pharmaceutical majors have either pulled off their trials from India or are adopting a ‘wait and watch’ strategy.

A peek into the future Predicting future, Saxena adds, “It is difficult to predict how things will be in 2020. One is hopeful that the current chaos will be resolved and the industry will stabilise, as our rules and regulations are getting aligned to the international standards and some of the best practices are adopted. This will help resolve some of the current issues today.”

India has lost its position of being a clinical trial hub during the last few years, primarily due to faulty regulatory policy.

India, which was then chosen to be the clinical research destination of choice, is now going through one of the toughest times in the history of the Contract Research Organisation (CRO) industry.

If the regulatory norms are reformed, then sky is the limit for the Indian CRO industry and we could expect a $ 2 billion top line by 2020.

Besides adhering to the norms, it is important that pharmaceutical majors bear on mind certain points during conduction of clinical trials. They should adopt good clinical practices and ensure proper informed consent, subject compensation, data quality and integrity

norms at par with the international standards when executing clinical trials without compromising on patient care, quality and integrity of trials.

Need for collaboration Collaborations are important as they not only bring in revenues in terms of foreign exchange but they also foster innovations.

With the pharmaceutical industry growing at a faster rate, it is required that latest technology be integrated along with good clinical practices to improve clinical trial standards.

Emphasising on the need for collaboration, Saxena states, “There can be substantial foreign collaborations and investments in the clinical trial segment and the only hindrance are the poor regulatory norms and approval related issues. The reason is fairly simple, R&D is shifting from a high cost, mono-centric, western concentrated model to low costs, polycentric, emerging market model.

India having submitted data to FDA for over two decades now, with the huge patient pool and medical infrastructure has the potential to be the dream destination for clinical trial outsourcing and 2020 may see this happening.”

Key takeaway points Faulty regulatory policies impact India’s rankings as a clinical trial hub Indian CRO industry could expect a $ 2 billion top line by 2020.

The clinical trial market has been adversely affected by the current government norms as well as some of the concerns around subject deaths, subject compensation and illegal clinical trials.

Nidhi Saxena Founder, Chairman & CEO, Karmic Lifesciences Collaboration is important for revenue generation and to foster innovations Need for reformation of regulatory policies

Jonathan Andrus Senior Vice President - Operations, BioClinica Kindly shed light on the factors that contribute towards the changing face of clinical trials in India and predict 2020.

The economy, regulations and the emerging trend shift towards paperless trials will be the key factors influencing change in the clinical trial process.

Certainly, financial pressures will continue to seep down the line from sponsor organisations to technology vendors, who will need to rise to the challenges.

From a compliance perspective, improved communication between the regulators and industry is definitely encouraging. Industry is rapidly embracing new technologies and approaches to help achieve quality and

compliant clinical trials. Integration of realtime data into a paperless clinical trial is the key in modern clinical trials.

As in the global context, highlight the areas for improvement of clinical trials and research in India and the path forward to 2020?

It appears as though, India is showing increasing commitment to continued improvement in the areas of clinical trials and research. Dotting on this position and further expanding its role in the global clinical trials scenario, requires well-trained and certified data managers.

For companies and research organisations to succeed in this challenging and highly

regulated clinical trial environment, extensive training, certification and education in data management techniques and tactics are imperative.

What are the innovations you foresee in the field of clinical research and trials by 2020?

One can expect to see more patientcentric clinical studies. You can also expect increasing convergence of clinical trial data with healthcare data. However, just how much of this clinical trial data will prove to be an innovation driver is uncertain yet. This is because, the extent to which routine healthcare data is used within studies is yet unknown.

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Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Herbals and nutraceuticals

Catapulting market dynamics Increasing number of clinical studies corroborating the health benefits of nutraceuticals and their broad applications in food, beverages, dietary supplements, pediatric and adult nutritional preparations have led to increase in use of nutraceutical ingredients. Also, faster growth in consumption of nutraceutical ingredients, has boosted the growth of the nutraceutical ingredient market worldwide. he herbs and botanical market globally are far from realising their full potential, as new ingredients and new benefits for known ingredients, are still being discovered. Market expansion, particularly in the functional food and self-medication sectors is dependent on consumer education. If a consumer is unable to understand the benefits of herbals, the segment will undoubtedly see a dip in sales. Additionally, increasing economic prosperity in developing countries including India, China, Brazil, Mexico, Russia, South Africa, South Korea and Poland will enable consumers to spend more on health and nutrition in the future.

According to various reports, looking at the individual market segments, future ingredients for weight control including green coffee extract, fraxinus excelsior seed extract, probiotics/synbiotics and alginate-pectin calcium gel will rule the market. Also, ingredient efficacy and therefore claim substantiation is expected to have the highest impact on new product development in the herbal and botanical markets, together with consumer education. This will require a larger investment in new products and their marketing.

Dr Sharad Kasarle, Chief Scientist, DSK Nutrition Research Center Pvt Ltd states, “The changing regulatory situation in Europe is making things difficult to predict, but it is safe to

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Q&A with

Tell us about the evolution of the nutraceutical segment The nutraceutical market in the West was established many years ago with products present for the last 30-40 years. In India, the nutraceutical market sprung up in 1990, but continues to be in its nascent stages yet. The Indian market though, has caught up pace with the introduction of products such as glucosamine for arthritis, coenzyme Q 10 for heart disorders and infertility, primrose oil for skin beauty and many more. Today, the pharmaceutical companies aspire to have increased presence in newmarkets propelling the rise of the segment. The nutraceutical market is valued at ` 7,500 crore.

say that new product development, especially in the herbal supplement segments will be slower in the near future. The new segments of functional food and nutricosmetics will continue to experience a double-digit growth rate and play host for many new exciting concepts. Consumer demand for more nature and exoticism in food will lead to increased use of herbs and botanicals in functional food, which will offset the present slower growth of the herbal drug markets. When the international harmonisation of herbal regulations is settled and definitions of herbal supplements, herbal drugs and herbal food ingredients are clear, another growth phase of the complete category will emerge. Regardless of what happens, new products and concepts based on solid science will be the winning strategy for international success going forward.”

Upcoming trends Medical nutrition, nutrigenomics and therapeutic medicinal herbalism will lead the wellness sector, in addition to functional foods and nutraceuticals.

Medical nutrition therapy, a nutrition-based treatment follows evaluation of a patient’s nutrition status.

This treatment can range from changes in diet to providing specialised therapies such as intravenous or tube feeding.

It includes performing an all-inclusive nutrition assessment determining the

nutrition diagnosis, preparing and executing a nutrition intervention using evidence-based research, monitoring and evaluating an individual’s progress over subsequent period of time.

Herbal medicine refers to using seeds of plants, berries, roots, leaves, bark or flowers for medicinal purposes. This line of medicine is going mainstream due to improvements in analysis and quality control, along with advances in clinical research that emphasise on the value of herbal medicine in treating and preventing diseases.

Nutrigenomics is a science that explains how genes interact with nutrients. It is a study on how DNA and your genetic code can determine individual’s need for certain nutrients and help maintain optimal health always. Nutrigenomics comprises of nutrigenetics, epigenetics, and transcriptomics, coupled with other ‘omics,’ such as proteomics and metabolomics that apparently account for the wide variability in cancer risk among individuals with similar dietary habits. This will soon take centre stage in the near future.

Key takeaway points Segments of functional foods to experience double-digit growth New product developments in herbal and botanical markets

The new segments of functional food and nutricosmetics will continue to experience a double-digit growth rate and play host for many new exciting concepts.

Consumer demand for exoticism in food will lead to increased use of herbs and botanicals in functional food.

Dr Sharad Kasarle Chief Scientist DSK Nutrition Research Center Pvt Ltd International harmonisation of herbal regulations Therapeutic medicinal herbalism to lead wellness sector

Dr R K Sanghavi Consultant - NeuroMarketing (Pharma), Chairman - Nutraceutical & Medical Subcommittee (IDMA) Do the regulatory norms laid by FSSAI promote market growth?

The nutraceutical market is fantastic and the products are shown to deliver results.

However, since the establishment of the Food Safety and Standards Authority of India (FSSAI) in 2011, formed with a vision to regulate the nutraceutical market, the body has come down as a very strong clamp on the market growth.

Extreme rules have made it very difficult for approval of products. The FSSAI is charging exorbitant fees of ` 25,000 to approve a single drug. FSSAI should not lay down such strict regulatory norms.

Currently, FSSAI is trying to cap the

quantity of vitamins and minerals as per the Recommended Dietary Allowance (RDA). The nutraceutical industry bodies were not asked for recommendations before passing the Act and hence they feel let down. These new norms have created a lot of turbulence in the industry.

What efforts should be made to streamline growth of the nutraceutical sector?

In order to drive the nutraceutical sector forward, FSSAI must recruit personnels with medical background, who possess industry experience with regards to product composition, product launches

and commercial activities. These personnel should understand the difference between nutrition and nutraceuticals.

The nutraceutical industry’s reliance on FSSAI norms is an unhealthy trend. There must be a separate law governing the nutraceutical sector. FSSAI should be more industry friendly with proper governance and not pass laws that may hamper growth.

If the regulatory body opposes launch of new products, then Indian consumers can purchase them overseas. This results in heavy revenue losses and hence FSSAI should allow business operators to put across their point in cases of rejection of new products.

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Pharma logistics Nikunj Sharma nikunj.kumar@network18publishing.com

En route to safe drug delivery The supply chain management is a subject of relevance and critical importance in the pharma industry today and decision makers play a very crucial role. Transferring onuses on infrastructure related issues and technicalities involved, do not address the core of the emerging industry concerns. Explore the path ways to timely drug delivery with Nikunj Sharma. ndian pharma sector is well-equipped with modern infrastructure facilities and a good value chain with reliance on backward linkages with raw material suppliers as well as forward linkages with the different distribution networks such as distributors, stockists, retailers, etc.

Pharma supply chain involves various stakeholders right from the drug manufacturers, Active Pharmaceutical Ingredient (API) suppliers and dealers of the raw materials such as packaging materials to the manufacturers of pharmaceutical products, transporters, retailers, wholesalers, medical practitioners, healthcare providers and consumers as a whole. Drug supply chain is reliant on strong linkages, those which are trustworthy and accessible to players across the drug supply value chain.

Karl Vandenbussche, Director, Reynders Label Printing India Pvt Ltd states, “The Indian pharmaceutical industry

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The Indian pharmaceutical industry holds a distinctive position in the global pharma market with clinical trials, Contract Research and Manufacturing Services (CRAMS) and generics that have to reconsolidate their supply chain.

Karl Vandenbussche Director, Reynders Label Printing India Pvt Ltd

holds a distinctive position in the global pharma market with clinical trials, Contract Research and Manufacturing Services (CRAMS) and generics that have to reconsolidate their supply chain. The increased competition has unveiled more challenges in cost-competitiveness, quality, market speed and distribution penetration.

The lean management philosophy to improve effectiveness and reduce the supply chain cost should be evaluated to deliver maximum customer value. Initiatives like sixsigma, total quality management, theory of constraints, just-in-time production have been improving supply chain management for years. Theoretically, these initiatives can be perfectly implemented but they do not keep the work mentality and culture of a country in mind, which leaves room for the human factor.”

Evaluating need of the hour Emphasising on the need of the hour to bring supply chain management on a mainstream platform, Neeraj Vashisht, Senior Principal Consulting, IMS Health suggests, “A preliminary industry assessment indicated that many executives do not rate supply chain related issues among the top opportunities for the pharmaceutical industry. As in contrary to other industries, it is not uncommon for companies to make it to the top purely on the strength of their supply chains. According to IMS health assessment, not focussing on the supply chain as a source of competitive advantage can result in loss as high as 11 per cent of retail opportunity or as much as 4 per cent loss from excess inventory related challenges.

In the last decade, the pharma industry has experienced tremendous activity in mergers and acquisitions, but lack in holistic redesigning of their supply chain, thereby resulting in uncoordinated and often broken chains. Additionally, higher product diversity which is on the rise results in higher

complexity. Predicting demand at a granular level and linking it to sales force activity can be quite tricky. Too little sales push can result in excess inventory, resulting in expirations and higher reverse logistics cost. Too little inventory obviously results in lost opportunity costs.”

Efficient SCM It is impossible to develop a ‘world-class SCM excellent model’ that will be successful in tough and competitive international markets, over a sustained period of time in the pharmaceutical industry.

Efficient management of in-house resources and various key points that add value to a successful supply chain are the game changer.

“Internal stock management can be a solution but will increase costs for the supplier.

Procurement within a defined area can be a solution but not all items will be available and problems such as truck breakdown and materials can be rejected. There is no 100

In the last decade, the pharma industry has experienced tremendous activity in mergers and acquisitions but lack in holistic redesigning of their supply chain, has resulted in uncoordinated and often broken chains.

Neeraj Vashisht Senior Principal Consulting, IMS Health

per cent error free vs costeffective solution,” insists Vandenbussche.

With the emergence of IT-enabled logistics, these solutions are of critical importance to the majority of players in the pharma sector.

Advanced techniques such as integration of supply chain activities and information along with measurement of Key Performance Indicators (KPIs) can be effectively routed to develop a worldclass SCM pharma company.

Identification and measurement of customer service, as this ‘sets the spec’ for supply chain design.

“With globalisation, supply chains are getting longer. In the face of this trend, relying on high inventory levels to maintain service is becoming a costly affair but still is amongst the most widely adopted approaches.

This leads to difficulties in managing suppliers (contract manufacturers, logistics vendor, API suppliers). Fortunately, there are sophisticated models available to optimise the stocking levels that companies could take advantage of. These models rely on data and facts to suggest optimal manufacturing and stocking levels to maximise opportunity and minimise cost of developing structured processes to assess supplier performance, aligning supply chain incentives, periodically screening suppliers and continually optimising costs are all important ways to run an efficient supply chain. We believe that pharma companies can take a cue from their counterparts in other industries, and begin to streamline their supply chain to gain significant competitive advantage. In an era where both revenues and margins are under pressure, this is a capability companies can no longer ignore,” Vashisht reiterated.

By and large, in all perspectives, it is the collective responsibility of all stakeholders involved across the entire pharma supply chain to incorporate best recommended practices in order to deliver value to the end consumer.

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Anubhav Sharma anubhav.sharma @network18publishing.com

Sourcing pharma

The growth enablers

With the Indian pharmaceutical industry growing at a rapid rate, it is becoming increasingly difficult for Indian logistics to match up with the accelerated pace and draw a careful balance, while meeting the continually evolving supply chain needs. he Indian pharmaceutical industry ranks fourth in the world, in terms of production and is expected to reach up to $ 1,100 billion in the next two years. Considering this projected growth, it is necessary that the pharma supply chain is at par with the industry standards to meet this boom.

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3E challenges This rapid projected growth implies that the pharmaceutical logistic sector is posed with 3E challenges that lay ahead as in Ethical, Economical and Environmental issues.

Akshay Sharma, Chief Operating Officer, Schedulers Logistics India Pvt Ltd says, “The focus on pharmaceutical

The focus on pharmaceutical development will be through clear segmentation in terms of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and finally Good Retail Practices (GRP) Akshay Sharma Chief Operating Officer Schedulers Logistics India Pvt Ltd development will be through clear segmentation in terms of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and finally Good Retail Practices (GRP). The logistics would be involved mainly in the GDP where the primary responsibility would still lie with the manufacturer.”

The logistics can be improved with the help of traceability of the products, direct to marketplace such that the intermediate storages are dispensed with, and there is direct distribution from the factories to the retail shelf, use of temperature controlled logistics, and growth of organised retail in pharmaceuticals.

As far as the ethical problems are

concerned, non- compliance to various good practices in manufacturing, distribution and retailing accompanied with the need to earn more profits by adopting unethical services have to be addressed.

“These problems can be overcome by simply ensuring certain things. First being, Logistic Service Providers (LSPs) should be treated as partners and not as

vendors. This will make them invest in the infrastructure and workforce, which in turn will lead them responsible for any GDP dilution,” Sharma elaborates.

Future in store The recent growth demands a better service to foster innovative efforts in the pharma logistics sector. Sharma

predicates, “Five years from now on, we can expect a shift from unorganised retail to organised retail. This will require a strict GRP. The stricter norms will see a gradual shift towards temperature control management and traceability.

This increased requirement will give rise to evolved training centres that offer skilled workforce.”

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Pharma supply chain Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Time for uplifting standards

The pharma supply chain needs to undergo technological transformation, to keep pace with the increasing industry demands. The existing degenerating systems are now replaced with intelligent technology. Proper pricing margins, tax efficiency, ground staff training and improved infrastructure will play a crucial role in setting grounds for an effective supply chain.

ntil recently, pharma companies failed to recognise the significance and profitability of an efficiently managed distribution network.

While drugs were being manufactured efficiently, the supply chain continued to remain fragmented. The pharma supply chain in India is struggling to catch up with the pace of demanding regulatory environment. If Indian companies would like to globally position their products, rapid improvements are required from Logistic Service Providers (LSPs) and pharma companies alike.

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Empowering supply chain managers Currently, pharma companies supply manufactured drugs to a Clearing and Forwarding Agent (CFA), who then passes it on to the stockist. The retail pharmacies acquire drugs from these stockists.

Stockists are selected based on their location and quantity of sales generated rather than their infrastructure. Pharma companies should empower their supply chain managers such that, they are able to select stockists based

Pharma products are expensive and hence prone to pilferage.

If an eagle eye is not kept at the Container Freight Stations (CFS), the tendency to remove part cargoes from a box cannot be eliminated.

Capt Dinesh Gautama Advisor, Container Shipping Lines Association (CSLA)

on their infrastructural merits.

While consolidation centres and warehousing conditions play a key role in maintaining the integrity of a product, auditors must also be made aware of the regulatory framework and engineering principals that guide optimal functioning of the warehouse.

Intelligent IT for safety Pharma companies can now track products and tackle counterfeiting issues that are responsible for huge revenue losses. Counterfeiting is more likely when containers stuffed with pharma products are transported long distances inland to the Inland Container Depots (ICDs). These tracking devices ensure integrity of the product by providing temperature and shelf-life data.

Further, transportation and route planning, labour management, GPS tracking are some of the technologies being increasingly adopted.

New companies are allowing businesses to make use of cloudbased technologies for complete transportation management including fleet maintenance, mobility support etc. This aids in cost reduction during transportation and enhanced financial operational control.

Temperature controlled SCM Earlier, certifications in the pharma sector were only limited to Good Manufacturing Practice (GMP), which has extended to Good Distribution Practice (GDP) today.

The pharmaceutical cold chain needs to be controlled, analysed, measured, documented and validated at every step.

Rajeev Saxena, Chief Operating Officer, Agility Logistics states, “The regulatory agencies such as Medicines and Healthcare products Regulatory Agency (MHRA) and USFDA ensure that the statutory compliances are well understood and that the standards are met. The term ‘ambient control’ is already out of the window. The quality control department is insisting on data logger reports to verify excursions.

The agencies are going beyond GMP’s and GDP’s to question the sourcing of ingredients, their

storage and usage pattern till the final production of drugs.”

Saxena adds, “Over the next decade, FDA will transform from a predominantly domesticallyfocussed agency operating in a globalised economy to a modern public health regulatory agency.

FDA is already working to increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by industry, and enhancing collaboration with international regulatory counterparts and other third parties.”

Product movement in pharma The movement of pharmaceuticals in a supply chain is fraught with many risks, which may affect the efficacy of the pharma product. While all efforts are made to ensure that the guidelines and parameters of transportation are maintained, the infrastructure cannot be ignored. There are bound to be pitfalls despite all the controls and surveillance that go into it. When pharmaceutical products are moved via sea transport, the inherent dangers of infrastructure manifest easily.

Capt Dinesh Gautama, Advisor, Container Shipping Lines Association (CSLA) elaborates on the intricacies involved in pharma product shipping. Gautama said, “Pharma products are expensive and hence prone to pilferage. If an eagle eye is not kept at the Container Freight Stations (CFS), the tendency to remove part cargoes from a box cannot be eliminated.

Thereafter, the movement of pharma from the CFS to the port has to be carefully monitored.

Sometimes more pilferage takes place within the port than outside the port areas. Another area that needs careful attention is when temperature-controlled products are moved in refrigerated containers. Medicines and similar products are transported in narrow temperature ranges between 5 to 15 degree Celsius, unlike carriage of frozen or chilled food stuffs at minus 30 degrees Celsius. Although ships carry spare parts for repair of refrigerated containers, all bills of

The regulatory agencies are going beyond GMP’s and GDP’s to question the sourcing of ingredients, their storage and usage pattern till the final production of drugs.

Rajeev Saxena Chief Operating Officer Agility Logistics lading generated by the shipper exonerate the ship from any damage or loss due to variation in temperature.”

Further, as medicines are produced at high costs it is essential to ensure that relatively new refrigerated containers are used for long sea passages. The conditions of the containers, although ISO certified may not follow the maintenance programme, and should be checked, if certified

by The Institute of International Container Lessors (IICL). The seals of containers should be checked at all times and an Equipment Interchange Report (EIR) should be received when handing over to a different party.

Future goals Pharma companies are slowly realising the criticality of an efficient supply chain. With track and trace systems in place, processes such as recall of drugs has become easier, thus maintaining credibility in crisis. Greater awareness of processes among the regulators, auditors, stockists, CFAs and retailers and their seamless integration through technology will steer pharma industry towards healthy growth.

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Both pharma and logistics can maintain the existing growth rate of 15 to 20 per cent annually, if they stick to adopting industry best practices.

What are the logistic services offered

by TCI to the pharma sector?

TCI services the pharma and healthcare sector throughout the entire value chain by offering services such as: Inbound logistics, wherein bulk intermediates/APIs and chemicals are transported to the manufacturing plants.

This service is offered by TCI Freight and TCI Supply Chain Solutions.

Warehousing/Third-party logistics (3PL) - TCI Supply Chain Solutions provide DC/CFA management covering inventory, invoicing, distribution, typically end-to-end forward supply chain with some parts of reverse logistics being incorporated as well. This will also cover working with Drug License (DL), wherever and as required.

Temperature controlled movement – The temperature controlled movement is handled by TCI’s express logistics division, TCI XPS. During transit, special boxes with gel packs secure the cargo during delivery period, which is normally within 24-48 business hours.

Outbound logistics/distribution – The TCI XPS services are so made to handle full loads, as well as part loads, using containers that offer reliability and security when handling sensitive products.

What are the critical issues in pharma supply chain?

Pharma and healthcare industry continues to remain slow in innovation, and hence,

the challenges that continue to exist are lack of third-party logistics outsourcing, traditional warehousing vis-à-vis modern shared/dedicated warehouses, investments made towards product packaging and on complete ‘temperate-controlled supply chain management’ at the back-end and hesitance towards forming partnerships with 3PL. Take us through the changes witnessed by the pharma logistics segment in the last decade.

Recognition, maintenance and controlling, the ‘right temperature and form’ of raw materials and finished goods throughout the entire supply chain has been the prime change witnessed by the industry and service providers. Technologies like Global Positioning System (GPS), data loggers, temperature and humidity monitoring devices at product level/box level/vehicles/ warehouse level has seen remarkable change and investments in modern warehousing. GMP, HSE, HACCP, FSAS concepts are now prevalent across the board while maintaining the stringent requirements, as outlined by FDA. Also, multi-modal reefer containment through rail is now possible.

What kind of growth rate does the logistics industry expect, with the projected growth in Indian pharma?

Both the pharma and logistics industry are growing at a rate of 15 to 20 per cent annually. This will continue to remain.

However, the impediment here will be the slow adoption of best practices by the pharma and healthcare industry players, as in comparison to its peers.

Are you planning to launch any innovative service to serve the pharma logistics segment better?

TCI already has its high quality reefer vehicles fitted with GPS and data loggers serving the critical vaccine and capsule industry. On the warehousing front, TCI is in the process of building state-of-the-art, modern warehouses at Nagpur, Hyderabad, Chennai and NCR, besides the already existing 9.75 million sq ft warehousing space. In these facilities, multi-temperature warehousing zones will be created for the industry at large, which can be customised too. Further, ‘Operation Control Centres’ (OCC) have been implemented as back-end support. This will enable the pharma industry to track-trace and visibility in an era, when it is fighting counterfeiting and pilferage.

Pharma logistics sector has leveraged many features like safety, traceability, reduced time-to-market and reliability across the entire logistics network.

Vineet Agarwal, Joint Managing Director, Transport Corporation of India Ltd (TCI), gets candid on crucial aspects of this business with Nikunj Sharma.

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Projects

Modern Pha rm a | 1-15 July 2013

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesciences industry.

Bulk drug and intermediate manufacturing project Project type: New facility Project news: Tooba Pharmaceuticals Private Limited is planning to implement bulk drug and intermediate manufacturing project in Aurangabad. The production capacity of bulk drug and intermediates for the proposed project will be 100kgs/month.

Project cost: NA Implementation stage: Planning

Project location: Aurangabad, Maharashtra Project cost: NA Implementation stage: Planning

Medicine manufacturing unit Project type: Facility expansion Project news: Ranbaxy Labs has been ďŹ ling applications to unveil generic versions of top-selling medicines from its local plant. For the production of its generic version of the cholesterol-lowering medicine, LIPITORÂŽ (atorvastatin calcium) from US, Ranbaxy Laboratories Ltd aims to expand its manufacturing unit at Mohali in Punjab state by adding another block in 2014 to cater to increasing demand for oral drugs.

Contact details: Tooba Pharmaceuticals Private Limited Plot No: A-117, A-118 & A-119, Paithan Area, Aurangabad (Maharashtra), India.

Tel.: +91-240-23332138 Mob: +91-9822651107 Email: jaweed@toobapharma.com

Injectable drug plant Project type: New facility Project news: Production of specialty injectable drugs is forecast to begin commercial production in the second half of 2014 and ramp up over the following 24 months.

Project location: Vizag, India

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Out-licensing planning with multinational pharma Project type: New facility Project news: Orchid Chemicals and Pharmaceutical is engaged in drug discovery for therapeutic segments. These segments include diabetes, inammation, cancer, auto-immune disorders, anti-infectives and obesity.

Project location: India Project cost: NA Implementation stage: Planning

Project location: Mohali, Punjab Project cost: NA Implementation stage: Planning

Contact details: EOrchid Chemicals & Pharmaceuticals Ltd Orchid Towers #313, Valluvar Kottam High Road, Nungambakkam, Chennai - 600 034 Tamil Nadu, India Tel: +91 - 44 - 2821 1000 / 2823 0000 Fax: +91 - 44 - 2821 1002 Email: corporate@orchidpharma.com

Contact details: Ranbaxy Labs Plot 90, Sector 32, Gurgaon-122001,

Shasun pharma’s expansion project Project type: Facility expansion

Project news: The project will thrust on a nanotechnology joint venture for cancer cure with US-based Nanoparticle Biochem Inc. Shasun mainly manufactures APIs for several pharmaceutical companies globally It has recently entered the branded market in India with the launch of a diabetes product and a blood-thinning drug in Tamil Nadu.

Project location: Tamil Nadu Project cost: ` 100 Cr Implementation stage: Planning Contact details: Shasun Pharmaceuticals 3rd & 4th Floor, Batra Centre, 28, Sardar Patel Road, Guindy, Chennai – 600 032, Tamil Nadu, India Tel: +91-44-43446700 Fax: +91-44-22350278 Email: shasun@shasun.com

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India t 5FM t 'BY t &NBJM QBSNFFU E!UFOEFSTJOGP DPN

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Contact details: Hospira, Inc. Advanced Knowledge Center 5729 Fontanoso Way San Jose, CA 95138 Tel: +1-800-241-4002 Email: supportservices@hospira.com

Haryana, India Tel: +91 -244 135 000 Fax: +91 -244 135 001 Email: corporate.communications@ ranbaxy.com

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CEO, ion open up of unit nities in the Meda acquisi in the Foundation manofy a .change.Wit and control field of expenditures tion in a statement.

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Ozone Pharmaceutical is planninge-to issyst a step closer towards realising ded con turers13th Plan rts of with trol tech generic breakthr us group ems, acqu eng India, the demand for these services has sellSun medicines chronic diseases the universal coverage 2022 Over the decade things have improved and s, has oug providi Pharma for ineeredhealthcare nologies isition h in ann Lipaglyn “Due diabetes and ng prec plans rese and oun ced a outstripped supply.â€? Dr Menabde said, vision that seeks solu to entitle health there have been its failures successes.â€? tions.universal to the for $ blood 5 billion.pressure isio in like targeted ™ (Saroglitaza arch efforts rece pricing the pres “If the provides effective entitlement to every citizen, guarantee nHe also highlighted that under a uniform initiative ctor,government withof Dire r), athe agenda Zydus concern s and nt speculat need for at bridging novaffordable been el dru Cad financing to deliver services all is to make theandream of where will costnew as low as ion ` 2 per ingthey our drea ila. “It to people in access to an essential health package and g from another Med s med Hypertr treating Dia unmet heal m a mer has to beti thca ia a responsive way, ensure fair regulation healthcare a reality and everyone has to tablet. “We have decided to take this integrate healthcare delivery.â€? take iglyc the alwa pha c dyslipid re Tod ging concept rmaceut erid we hav a molecul ys ben which emi ay, uniform pricing initiative with to make stag cannot emia in Typ market e decided ical compan alone. e II diab a or an imp we have real e up to its e right glyc eficial effects be con these medicinestoaffordable despite the y, The that laun etes ised emi troll orta info of drug ch. , like there c such ed by this drea nt brea the rm Lipaglyn control in both lipid disc are stati kthr to factussi that this will impact ourthe margins Drug Con has been m. It is not to ons. Med currently approve ns scie dedicate this ough, and (DCGI) troller tablets. ™ is recommdiabetic pati and no CMD, ntists com substantially,â€? said I wou d by to all a’s S C Sehgal, ment in the will not ents. ended This drugfor its laun General of on spec policy is field of Indian rese ld cent of Almost 85 The Ozone Group. ch in India as ulat perf announ do so in the cou offers Lipaglyn new drug drug discoverarch from all diabetics per cent to 4 mg the futu ion and cement lipid andorms a nov are estim diabetic 97 per ™ was base applica y.â€? policy,â€? el actio ntry. clin re. Thi in one is an ushers ated non dysl tion Wockhardt n that ical Med d molecul glucose low ptio intostop Glit a said exce develop on a compreh for to -thiazolidin ipidemia. Lipa to suffer erin While 3 Indian e. Lipa to our Phase-I azar to inpharmancompanies edione, be app ensive glyn™ g effects , Phase-I ment Pharma a spokesp a statement. be app is the first glyn™- a the roved in the is the trials, pro I and Ltd,gram said,me “We will be initially cosmeticther segment.â€?

Wockhardt Ltd delivered 95 per centworld.STEMPEUTICS roved Research The span first compan for this con commen had earl erson of Sun apy the first ning eigh Phase-I “LipaglyPvt Ltd, a any where in deve ditio II clin it in the ier launching Indian and yAlthough we have increase in Profit After Tax (PAT) company t has t on n. not yet year refu in n™p ical the lopi spen based from s. Resu rovides stem cell-based ng Lipafinalised the Pioglitaz Phase III t $ nature firm at ` repo 12 year 250 mill Malaysian and later of the final 378rts, crore in sed the first developing to quarter ofdiabetic lts from market patients s to fruc glyn which of a poss also announ the Mumba of onc ion dyslipid products diabetes one as a comprogramwe suffwith another meplan to expand to South product, wetook will near be focusing financial ced yearthat 2012â€?13. i-The EBITDA medicinal tify. e-daily erin ible deal emi with pati g It para $ 150 ben will indications ents oral therin a, Bengaluru, repo lynamely the dose tor drugAsia followed werecrore the by Europe be - on two at ` 502 grew byrts 61 per cent efici and al effec facilities ‘specula apy that option trigl of Lipaglyn showed that East NPPA in year drug in over $ 200 million spending asquarter t on both well as Manipal ™ led the and4US.â€? hair growth. consecutive 10th tion andlipid Kuala Lampur, ycer .’ has a seasanti-ageing and to laun s peri mg essent starts represented ďŹ xing R Pate glycisemi ch od, Pate mar para an incr ides and LDL to a reductioStempeutics com conprocess ial meters of sequential will In kets addition of bringing in nextStempeutics price ofgrowth.This sustained l, Cha in cthe panbey coming trol,â€? said ease in n of The Nat drugs 3-5 expects l issaid . Inworking showed HDL cho cholesterol, 348 trea OTC product an stem up with still EBITDA and PAT performance, both in itsirm first therapy India, on the cost Lipaglyn kaj and cell Pan and its first ting Authori ional Pharma lesterol ‘Dia Managin Glucose a reduction indicate an ann - Stempeucare by ual 2013.beti It cisdyslfactor, and trying the to make its terms of value and margins, now ushers product in the Indian market. ty Manohar in Fast and also g and glyc d for the pric (NPPA) ceutical Pric turnover ipid eme has nextthe ing the top 3 best Wockhardt amongst derived from cell-based more Stempeutics is working on (HbA1c) ia,’ to products osylated ing Plas 3-4conditioned of stem ma clock are und e of 348 esse started fixin ` 100 year haem medium ebycell isolation croreasincompared in which to the performing Indian pharma companies. two products; Stempeucell, automatedther stem ntial drug g With thestems. cells economical confirm oglo bin Order er the Dru the Manohar current s that g cultured. existing treatments. a stem cell-based product, is device that will prove a boon ing have beentowa (DP success, rds its Manohar its The agen CO) of Price Con target ofthe added, Zydus“We are making efforts Professo entit by using trol Division Piramal’s and the year Imaging is on track beco r Dr slated to be commercialised for cosmetic surgeons is said, “We yare Author cy has aske 2015 and 201 M d Stat Molecular by 2014-2015.

It is currently expected to be launched by conditioned medium from that the is min to ggeta $the covered ities (SLA IBA N V 3-bilproducts e Licensin3.in pactStra Dr Dimitrio list of lioninsurance.�

Ravtrials. ent $ 1.4-b i KumAnother 2014. B N Manohar, CEO, rich in growth factors and currunder SA (Piramal) in sPhase III medical to pro Imaging thcly g manufacs) Piramal Lamprou ar that, illion. and vide the BiomedicdeanInstitute ture , of pro - Shibani Shah and IBA Molecular announced product Stempeutron, a fully unlik Stempeutics Research Pvt cytokines for its potential use of Pha the al their terr ducing thes rs operati e Scie tradi form rmacy nces the drug tional table agreement IBA Molecular ng itori e dru whereby of atom , believe and s This mov es. gs in knodistribute nanomed are not released ts and caps ic forc an advanced and wn as e will allow will manufacture ules, e mic the lates Peak boostdiagnostic encapsula icines are abso in the gut. Inste nanopar 18F-Florbetaben, Piramal’s t developm Force QN roscopy, rbed intac ted drug ad, ticles to to com information NPPA to colle M, cou the radioact pan imaging agent, European and ents in s be give omedicin and ct in the nan data relat ive ld offer bodily tissues, are released t and the sales of y turnover the es, potent directly to be able label, in orde n a fluo , marUS major vaccine research experience markets. ed 18F-Florbetaben rescentnew business from ket shar drugsis a the CLINTEC encapsul fieldInternational into of dosa s the possibilit including the r to DPCO. certain drug or to billio e, and blood. atio its operations pharma to join yitstoalready has expanded radiopharmaceutical currently s enlis nths of inintiny part However identify and allow scientistscompanies. The This reduceestablished ted und sources, According icles mea n of thera ge without trackcompany a metre into , by usin the atomic to is continuing to teams com in prom Africa andrequ Asia.

Malawi. ClinTech has development with er for usedesc them. ribedPositron peutic effec g ired forc for imp the 45-day time some indu diameter. suring howthethis inpartnered ising Buttar, appr(PET) moveme e microsc PeakForcexpand stry with oa pharma Emission Tomography for lementa The exciDrts.� Rabinder oach may on the e QNMinto interesting new The detailed od is shor opy, DPCO y used nt can tion of peridetection pien grow also President, for vaccine plaque help company imaging ts such CEO and circulates new ceili t, of beta-Amyloid oparticlefor clinical research. ing conc be trac nanregions to scientists 15 May 2013 became ng pric in the brain, erns around encapsul ked As the pharma industry F oulat u n d e r , as poly C l imer n T e c administ throughout development and form deposition a pathological , 2013 addressin Africa e. effective as it ‘nanotox in the med the bod ating drug e the nan ratio order s, and micr n. effec from icology’, Asia.icalAfrica repl y, after brin increasingly focusses its stated, without feature associated with This oparticl oscoAlzheimer’s s may exhiGroup, ts when International world is a pivotal pic part oral regulatio ging 348 drugaced the 1995 e- radi attaching can be mad drug dire build for the gut icles in the ctly “Despite thebitchallenging region development and other neurologic conditions. und Prof. Kum oactive any fluo e possible development efforts people’s -up of if wall. Scientist absorbed thro esired previous n, as compare s under pric ar, labe has who drug load economic of adult is publ our lead resc on the emerging markets, ls and nanopar been tissues. and paediatric s are keen conditions se e ugh the d to 74“18F-Florbetaben by usin ent or market ly, on the ticle-bas ished in team’s resea said,molecular drugs to many basi through which of accumul ed nanopar infectious compound in the rch articagainsteffec g theClinTec will closely partner price of “Nanotechimaging the journ vaccines ticles. real le caus ts on patients ed drugs have discover, ation of a drug s of nom al nolo has PLO In area inal and we are with its clients, aligning its diseases.

The company business, that particula theconfident gy’sit andclients nanopar .

S ONE e morise in our adverse s can power in partare restructuring , of wrecruiting r, harm than to trans role in drug aretogiven icular, ClinTec detecting be identified ticles in specservices and operations to theirgood organisations, the deliv process has the potential increase clinicians’ Till now form if they ery med ific causes , very Dr Buttar intosom about condition fit with their needs�. grow skilled personnel accuracy and so. confidence,� said Ajay the way s over The good icine of ‘tissu easily, thereby little e caseand win whawith continues the next patients e stiffn thingGroup. circulate t happens has been kno s. including linked to Piramal, Chairman, Piramal about nano decade or ess’ – variety wn through after nan canc a medicine if they er. of oparticle Add out diseases s is s atom itionally, , patient. raise any safet the body recent ic forc and Previous y studies it is poss e microsco ly, it was issues for usin py ible to necessary the mali distingu have shown thatg gnan for , the basi t and malignan ish between s of their t tumours nonrelative cells, on stiffness.

Advanced form of

Technical Articles, Case Studies and Product Write-ups. The length Yo can send us Tech You chnical Art of the article should shoul uld d not exceed exce 1,200 words, while that of a product write-up should not excee ed 100 words exceed words.

South East Asian countries Next hub for outsourcing?

Roundtable 18

Tenders

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controlled centrifuge BOD : 15 July, 2013

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: Defence Research & Development Organisation (DRDO)

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of Workshops (COFMOW) -

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Loc Spectrometer (WDXRF)

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: Northern Railway

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Desc : Provision of computer controlled

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M odern Pha rm a | 1-15 July 2013

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32

st

Anniversary SPECIAL

Event List

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National Events

International Events

PHARMAbiotika Pharmabiotika 2013 is an exhibition that facilitate buyer and seller meet to network with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives; September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11, 2013, Korea

For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 – 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com Indian Pharma Expo The Indian Pharma Expo 2013 will serve as a perfect platform for pharma entrepreneurs and investors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and suppliers and distributors of pharma products under one roof to exchange ideas; September 20-21, 2013, Pragati Maidan, New Delhi For details contact: UBM Medica India Pvt Ltd Tel: +91-22-66122600 / 66122673 Fax: +91-22-66122626 Email: info.india@ubm.com Website: www.ubmindia.in Asia-Arvo Some of the primary highlights of this conference will be interactive session, papers, abstracts and programs. Masses from all over the world are welcomed to be the parts of this conference. Topics that will be discussed in Asia Arvo are genetics of AMD, understanding AMD, reprogramming and regeneration, gene therapy, small molecule screening and drug discovery, model organisms, gene regulation during development and disease, eye development inherited eye diseases, diabetic retinopathy, common eye diseases, signaling pathways, angiogenesis, crystallins, chaperons and heat shock proteins, oxidative stress, aging and eye disease; October 28-31, 2013, Ashok Convention Centre, New Delhi For details contact: The Association for Research in Vision and Ophthalmology Tel: +12402212900 Fax: +12402210370 Website: www.arvo.org CPhI India CPhI India will bring pharma professionals from all over the world to Mumbai and facilitate, initiate and close business deals. It will be a great opportunity for the industry to showcase their products and services while enhancing their brand at South Asia’s leading pharma industry event.

Exhibitors will include manufacturers

of Active Pharmaceutical Ingredients, Alkaloids, Amino acids, Antibiotics, Antibodies, Antimicrobial preservatives, Antioxidants, Biocatalysts, Biotechnology, Capsules/encapsulation, Chemical synthesis/analysis, Chira intermediates and lots more; December 3-5, 2013, Bombay Exhibition Centre, Mumbai For details contact: International UBMÂ Live Tel: +91-22-67692415 Fax: +91-22- 66122626 / 66122627 Email: vikram.rao@ubm.com Website: www.pmec-india.com

For details contact: Terrapinn Pvt Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email: enquiry.sg@terrapinn.com Website: www.terrapinn.com

P-MEC India With India’s pharmaceutical machinery and equipment market growing, decision makers from all over the world are increasingly looking at India for sourcing pharmaceutical machinery and equipment.

At P-MEC India, visitors will have the unique opportunity to showcase their products in front a large audience, building brand awareness and gaining new leads from over 85 countries. P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide - the ‘must attend’ event in the international pharmaceutical industry. It is a great platform for visitors to showcase high-quality pharma machinery and equipment, meet with key decision makers in pharmaceutical industry from countries, including India, China, US, UK, France, Italy, etc and network and build the brand in one of the world’s fastest growing pharmaceutical markets; December 3-5, 2013, Bombay Exhibition Centre, Mumbai

3rd International Conference on Environmental, Biomedical and Biotechnology 3 rd International Conference on Environmental, Biomedical and Biotechnology is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society.

It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore

For details contact: International UBMÂ Live Tel: +91-22-67692415 Fax: +91-22- 66122626 / 66122627 Email: vikram.rao@ubm.com Website: www.pmec-india.com

For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society Tel: +86-28-86528465 (China Branch) Email: cebb@cbees.org Website: www.icebb.org

34th International Conference on Bioscience, Biochemical and Pharmaceutical Engineering The main focus of this conference is to bring scientists, researchers and scholars together to exchange and share experiences and research results about bioscience, biochemical and pharmaceutical engineering, and discuss the practical challenges encountered and the solutions adopted. The conference will deal with topics such as bioscience, biochemical and pharmaceutical engineering, affective neuroscience, astrobiology; December 5-6, 2013, Sheraton, Bengaluru

4th Global Drug Safety Conference and Exposition The 4th Global Drug Safety Conference and Exposition will be based on the theme, ‘Revitalising Drug Safety – The Decade of the Patient.’ Drug safety has become one of the most challenging public health issues of our time. It is everyone’s responsibility to take action to address the serious threat to global public health posed by the pressing issues relating to unsafe medicines and the unsafe use of medicines. PSA’s Queensland Branch and the Global Drug Safety Leadership Team will bring together government leaders, drug regulatory agencies, drug safety specialists, healthcare professionals, pharmaceutical industry, healthcare technology providers, health insurance providers, patient safety advocates, and consumer groups from all over the globe in this premier one-of-kind drug safety conference and exposition;

For details contact: World Academy of Science Engineering and Technology Tel: +44-782-4879405 Website: www.waset.org/ conferences/2013/bangalore/icbbpe/

AHMEDABAD

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

PUNE

Gujarat September 20-23, 2013

Maharashtra October 18-21, 2013

LUDHIANA

AURANGABAD

Punjab December 20-23, 2013

Maharashtra January 10-13, 2014

CHENNAI

JAIPUR

Tamil Nadu November 14-17, 2013

Rajasthan Nov 29 - Dec 02, 2013

INDORE

KOLKATA

Madhya Pradesh Jan 31 – Feb 03, 2014

West Bengal February 21-24, 2014

For details Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

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October 14-16, 2013, Brisbane Convention and Exhibition Centre, Brisbane For details contact: Ozaccom+ Conference Service Tel : +61 (0)7 3854 1611 Fax: +61 (0)7 3854 1507 Email: gds13@ozaccom.com.au Website: www.gds2013.org Drug Discovery Re-Invented: Emerging Role of Biotechs, Academics and Non-ProďŹ ts The conference will center on new approaches to drug discovery in an industry where the landscape is changing rapidly. With large pharma reducing investment in internal early stage research, drug pipelines will increasingly be filled by alternative sources. These players include: government, academic labs, non-profits, biotech companies, and pharmaceutical “open innovationâ€? models. The conference will also provide examples of successful strategies for advancing new drug candidates in this era of distributed discovery; October 16–19, 2013, Hilton Scottsdale Resort & Villas, Scottsdale, Arizona, USA For details contact: Tel: +44 (0) 1638 724137 Fax: +44 (0) 1638 724135 Email: admin@fusion-conferences.com Website: www.fusion-conferences.com 5th Pan Arab Human Genetics Conference The conference will focus on topics ranging from cancer genomics and NexGen sequencing to molecular profiling and pharmacogenomics.

International and regional experts will take to the platform to deliver their lectures on these topics. Researchers will be encouraged to submit their abstracts for oral or poster presentation at the conference. Also, a special feature of the conference will be a workshop on rare disorders; November 17-19, 2013, Al Bustan Rotana, Dubai-UAE For details contact: Meeting Minds Experts Tel: +9714-4270492 Fax: +9714-4270493 Email: pco@pahgc.org Website: www.pahgc.org 2013 International Conference on Pharmaceutical and Biological Sciences The aim of the International Conference on Pharmaceutical and Biological Sciences is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in pharmaceutical and biological Sciences; November 17-18, 2013, Cristal Hotels & Resorts, Abu Dhabi, UAE. For details contact: Tel: +86-28-86528465 Email: icpbs@cbees.net Website: www.icpbs.com

Top 10 books of the season

Modern Pha rm a | 1-15 July 2013

33

For an insightful read uring the last decade, the global pharmaceutical industry has witnessed a significant boom. Emergence of new business models have created a need for pharmaceutical majors and professionals alike to stay abreast of the global industry trends, technologies, novel manufacturing practices, regulatory reforms and supply chain management processes to ensure value delivery across the entire pharma chain. Dr Mandar Kubal, Director, Infectious Diseases

D

1

Handbook of Injectable Drugs 17th Edition Editor: Lawrence A Trissel Publisher: American Society of Health – System Pharmacists

2

Pharmaceutical Extrusion Technology

3

Advanced Aseptic Processing Technology

4

Natural Standard Herb & Supplement Reference

5

Editors: Issac Ghebre Sellassie and Charles Martin Publisher: Informa Healthcare

Editors: James Agalloco and James Akers Publisher: Informa Healthcare

Editors: Catherine E. Ulbricht and Ethan M. Basch Publisher: Elsevier Mosby

Handbook of Pharmaceutical Excipients (seventh edition) Editors: Raymond C Rowe, Paul J Sheskey, Walter G Cook, and Marian E Fenton.

Publisher: Pharmaceutical Press

and Pulmonary Care Pvt Ltd enlists the top 10 books that are a must-read this season. The leaders of tomorrow need the right tools to excel. Get the handy tools of success to understand the growing pharma sector better and meet the ever-increasing consumer and industry demands effectively. Leverage technology to maximise revenue generation and sustain business growth. Information on key business strategies, latest regulatory policies and factual insights are keys to success.

6 7 8 9 10

Performance of Pharmaceutical Companies in India Editor: Mainak Mazumdar Publisher: Physica – Verlag

Quality Control In The Pharmaceutical Industry, Vol 1 – 3 Editor: Murray S Cooper Publisher: East West Press

Phytopharmaceutical Technology Editors: P H List & P C Schmidt Publisher: Heyden & Son

Risk Management Applications in Pharmaceutical & Biopharmaceutical Manufacturing Editors: A Hamid Mollah, Mike Long, Harold S Baseman Publisher: Wiley

HardKnocks for the Greenhorn Editor: Anup Soans Publisher: Asian Trading Corporation

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

34

st

Anniversary SPECIAL

Products

Modern Pha rm a | 1-15 July 2013

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Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

Charging isolators Contained vessel charging solutions protect both the operator and the product, as low as to nanogram containment levels. Appropriate level of containment should be selected to suit specific operating procedures. The glovebox isolator is suitable for charging slurry and powder into reactors, and other vessels from small-scale synthesis to full scale production. The benefits include assessment of powder transfer method, powder handling characteristics, evaluation of material handling that include both manual or mechanically assisted requirements, vessel isolation method, and assessment of pressures or steam in place requirements, 3D models and full scale mock-ups. These involve total expertise from an original containment pioneer with precision built systems designed for longevity.

PSL India Mumbai, Maharashtra Tel: 022-28908232 Email: salesindia@powdersystems.com Website: www.powdersystems.com

entire perimeter with a silicone sponge rubber gasket.

Bullet feet with inbuilt screwing adjustment are specifically designed for long life under heavy load. The deep freezer is a heavy-duty refrigeration system, which is maintenance free with hermetically sealed refrigeration compressors for reliable refrigeration, while minimising noise and vibration. The freezer is such designed to follow the 21 CFR PART-11 Compliance. Other features include log data, event data, audit trail data, e-records, e-signatures, graphical analysis and data acquisition. Some of the optional features are GSM technology, hooter system and extra tray.

Mack Pharmatech Pvt Ltd Nashik, Maharashtra Tel: 2551-230877 Fax: 2551-230877 Email: info@mackpharmatech.com Website: www.mackpharmatech.com

Extruding granulating machine Air shower system Air showers are self contained chambers installed at entrances to clean rooms and other controlled environments.

They minimise particulate matter from entering or exiting the clean room. Enviro designed and filed, this latest programmable technology based controller to offer maximum application flexibility for every unit. The standard features are electromagnetic door interlocking, swing type doors with view panels, door open indicator, optional UV lamp on/off, hour meter for measuring the UV light life, fluorescent /white light on/off, blower on/off, alarm system, digital pressure measurement system and velocity measurement system.

Enviro Technologies Thane, Maharashtra Tel: 022-64646500 Email: ankit.s@enviroworld.in Website: www.enviroworld.in

Deep freezer The temperature range of a deep freezer is 60 degree Celsius with + 3 degree Celsius accuracy and + 3 degree Celsius uniformity. Eco-friendly PUF insulation with a thickness of 80mm and projected door prevents condensation.

This facilitates product view. Inner and outer doors are sealed around their

The basket granulator differs from other low compact granulating machines, as they use gravity feed aided only by a rotary agitator to prevent arching and the wetting powder falls directly into the extrusion area. The material is further wiped through a perforated screen with extrusion blades, that extrude and then fall on to the rotary table for discharge. The machine has an adjustable gap between the extrusion blade and screen, which allows for optimising extrusion force, low temperature due to short-path extrusion and choice of extrusion blades to suit process, narrow particle size distribution, and uniform extrusion pressure across the entire screen area. The extruding granulating machine finds application in feed supplements, colours, flavours, insecticides, inorganic chemicals, spices, pharmaceuticals, agricultural chemical and sodium benzoate.

Toshniwal Systems & Instruments Pvt Ltd Chennai, Tamil Nadu Tel: 044- 26445626/26448983 Fax: 044-26441820 Email: mixer@toshniwal.net Website: www.toshniwal.net

FBD inflatable gasket FBD inflatable gasket is available in transparent silicone rubber and white food-grade neoprene rubber.

The

gasket functions like a cycle tube. When inflated, it seals the bowl and ensures proper sealing. Being made of neoprene rubber or transparent silicone rubber, these gaskets can be inflated by 6-10 mm, when 4 Kg pressure is applied on silicone rubber and when 2 kg pressure is applied, in the case of neoprene rubber. The quality and craftsmanship of this inflatable gasket is at par with the international standards and looks aesthetically good. The FBD inflatable gaskets find applications in powder and bulk solid handling machineries, processing equipment, food processing equipment, conveyors, fluid sealing, robotics, material handling, medical sterilisers, electronic/wafer semiconductor processing, nuclear door seal, industrial washing and extractor machine and pharmaceutical applications.

AMI Polymers Pvt Ltd Thane, Maharashtra Tel: 022-28555107/631 Fax: 022-28555378 Email: amipolymer@vsnl.com Website: www.amipolymer.com

Food emulsifier S t e p h a n G e r m a n y offers multipurpose high speed microcut emulsifiers MC 15, MCH 20K for continuous process and consistent size reduction.

It is easily removable and consists of hard tipped, cutting rotors with no metal-to-metal contact. This ensures minimum product temperature rise and longevity of the tool life.

Combination of the Stephan rotor/ stator and the pre-cutting blade system operating at 3000 rpm, a size reduction of 1:100 can be achieved at a single process step. For eg, vegetables sized of 35 mm can be directly reduced to 0.35 mm. The capacity available from this food emulsifier is 400–1000-4500 kg/ hr, low power consumption, various in feed/discharge system and inline units available to suit the processes. It is ideal for fine paste wherein protein swelling is an advantage. This food emulsifier can also be used for grinding fish or chicken/ skin for fat recovery, fishhead paste, sea moss, and reduction for pet food, offal, feather for feed and chemical/pharma applications.

TRICON Pune, Maharashtra Tel: 020-25652205/25652451 Email: triconfood@gmail.com, trivedi@pn2.vsnl.net.in

Knife edge rolls

Knife edge rolls for lubrication-free belt deflection are used in the conveyor technology, especially in conveyor belts for the food and beverage industry.

The knife edge rolls help deliver goods carefully to the following haulage requirements. Users can dispose of a specially developed standard program from igus® knife edge rolls that are tailored for specific demands such as operating temperature and FDAconformity. This maintenance and lubrication-free machine’s elements are made of highly wear-resistant iglidur® materials to easily cope with the set tasks.

The universal and robust iglidur® P210 that is standard for igus® knife edge rolls distinguishes itself with features such as low humidity consumption, proper material resistance and a high service life. iglidur®A180 is used up to 90 °C and iglidur®A350 is applicable up to 180 °C. igus (India) Pvt Ltd Bengaluru, Karnataka Tel: 080-39127812 Email: deepak@igus.in Website: www.igus.in

Laminar air flow Laminar air flow unit is MOCSS 304/ SS 316 customised. It has imported mini pleat HEPA filter with hot melt technology that conform to EU-13/EU-14 grade at the supply position. The laminar air flow unit makes fresh air prefilter and conforms to EU 6 grade, with efficiency of 95 per cent down to 5-micron. Motor blower provided, is statically and dynamically balanced with sufficient capacity. Also static pressure is maintained to take care of the airflow requirement for entire life to HEPA. Dwyer makes Magnehelic® differential pressure gauge across supply HEPA filter. It has on/off switches for motor and lights, DOP test port at upstream of HEPA filter. Technical specifications are air cleanliness- ISO class 5 (ISO 14644-1: 1999(E)), air velocities- 0.45 ± 0.05 mps, air flow- vertical, noise level and vibration level stays minimum with power supply 230V ac 1-) 50Hz. The air flow unit can be either ceiling suspended or stand mounted.

Fabtech Technologies International Ltd Mumbai, Maharashtra Tel: 022-61592915 Email: marketing@fabtecheng.com Website: www.fabtecheng.com

Products Metal detector and X-ray inspection system Anritsu metal detectors with exclusive dual wave technology are designed to be accurate, small and easy to use.

The system is complete with many important production line features that are critical for a successful Hazard Analysis and Critical Control Points (HACCP) program. It has had more than 40,000 successful installations in food & pharma companies globally. The KD74 series, an X-ray inspection system delivers superior contaminant detection, stability and ease of operation in the meat, frozen food, ready meals and confectionery industries. Utilising advanced sensors and novel image processing technologies, the X-ray inspection system can detect ferrous and non-ferrous materials, as small as 0.3mm in diameter, and non-metallic contaminants including bone, shell, glass and plastic.

M/s Jay Instruments & Systems Pvt Ltd Mumbai, Maharashtra Tel: 022-2352 6207 Fax: 022-2352 6210 Email: marketing@jayinst.com Website: www.jayinst.com

Mini extruder Mini extruders have a separate stainless steel control panel with motor starter and inverter.

It is capable of ex t r u din g granules from 0.5 mm to 2.0 mm in diameter. The Good Manufacturing Practices (GMP) design conforms to 304SS contact parts. Technical specifications include working capacity of 100 gm/batch, dimension 0.5, 1.0, 1.5 and 2.0mm dia hole and electrical specification of 0.5 HP 230VAC/3/60.

Marchesini Group India Pvt Ltd Mumbai, Maharashtra Tel: 022-67082755/64 Fax: 022-67082761 Email: indiaphilippe@marchesini.in Website: www.marchesini.com

Precision regulator The precision regulator is light-weight and compact. It is diaphragm operated with relieving type (exhaust) precision regulators.

Janatics precision regulators are designed to provide constant output pressure with high degree of accuracy, by ensuring that the output pressure is maintained precisely irrespective of the fluctuations in the inlet pressure. They are available in 1/4-inch port size with supply pressure of maximum 10 kg/cm² and regulating pressure range of 0.1 to 8 kg/cm². The

M odern Pha rm a | 1-15 July 2013

sensitivity of the precision regulator is lesser than 0.02 kg/cm² and repeatability is within ± 0.04 kg/cm², with a flow of 1,100 litre/min. The regulator has a wide array of applications in metrology gauging systems, printing, textile, packaging, medical equipments and many more.

Marchesini Group India Pvt Ltd Mumbai, Maharashtra Tel: 022-67082755/64 Fax: 022-67082761 Email: indiaphilippe@marchesini.in Website: www.marchesini.com

Stability chamber Stability chamber is designed as per international standards to meet requirement of all registration authorities.

This equipment offers superior temperature accuracy, humidity

accuracy,

minimum heat loss, better air flow for maximum uniformity of temperature and humidity. Stability testing is an integral part of formulation development. It helps to generate information, which permits wellconsidered proposals to be made for the shelf life of drug substances products and recommended storage condition. Stability data is required to be submitted as part of the dossier submitted to the regulatory agencies for licensing approval.

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Shrink wrapping machine

Range of equipments include sleeve wrappers with shrink tunnel, web sealers with shrink tunnel, all-side wrapper with shrink tunnel, industrial application shrink tunnels, light duty shrink tunnel, shrink sleeve applicator, L sealers, automatic L sealers, automatic overwrapping/side sealers & tunnels and custom made machine suitable for client requirements. The applications for these machines are for packaged drinking water bottles, beverages, fruit juice cans, tetra packs, cans, glass bottles, pharmaceutical application, cosmetic packaging, printing and packaging, stationeries packaging, cosmetics, fruits and vegetables, bakery, confectioneries, electronic goods, print and paper packaging, industrial products, plastic products, furniture and wood products, gifts, dairy products, etc.

Varieties of shrink wrapping m a c h i n e s are available which includes m a c h i n e s suitable for PE, PVC, and POF film.

Vikaash Packaging Chennai, Tamil Nadu Tel: 044-42171271, 26201703 Mob: 0984103635, 09094036357 Email: vikaashpack@eth.net Website: www.vikaashpack.com

Sarbi Mumbai, Maharashtra Tel: 022-26049538 Email: sarbi1@vsnl.com Website: www.sarbi.com

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Anniversary SPECIAL

Products

Laboratory mixer/emulsifier UMC 5 model is a lab mixer/ emulsifier from Stephan Germany, which has a capacity up to 2.5 litre. It is a complete self-contained unit, designed to handle wide range of operations involved in pharma / cosmetic product development like size reduction, mixing, homogenising for gels, ointments, paste, syrups, powder mixtures and emulsions. The design of the bowl and blades ensure thorough circulation and intermixing of the products in a very short time.

Other features include, V/S Drive 3003000 rpm , heating at 95 degree Celsius and cooling unit for bowl D/J, temp probe, processing under vacuum and interchangeable cutting blade.

TRICON Pune, Maharashtra Tel: 020-25652205/25652451 Email: triconfood@gmail.com, trivedi@pn2.vsnl.net.in

Modern Pha rm a | 1-15 July 2013

Aqueous film coating system

GPS synchronised clock

Laboratory spray dryer

Four models for coating application have been developed. Instacoat EHP 250 is a single polymer PVA based coating system which has excellent water solubility and ability to perform at very high reconstitution level of 25%. Instacoat EMB is a single polymer (PVA) based tablet coating system and has excellent moisture barrier properties at 20% reconstitution level. Instacoat EEN is Methacrylic acid co-polymer (Type A or Type B or mixture of both) based optimised weight gain enteric coating system with 8-10% reconstitution level. Instacoat EHA is a high adhesion HPMC based film coating system at reconstitution level of 15%. The whole E-series film coating system has excellent adhesion, moisture barrier and high spray rate without gun choking and in minimum possible time.

GPS synchronised clock solution provides a unique and error-free timing solution for the entire facility.

It features GPS satellite synchronised timing with no need of manual setting / adjustment. It is built with a wide range of LED display size from 20mm to 200mm and colours ranging from red, green and white to work in any environment. It is a complete wireless solution which helps in eliminating expensive cabling costs and significantly reducing the installation time. It is also equipped with SS-304 stainless steel housing and flame-proof enclosures available for hazardous areas.

There are various choice of mounting options such as table-top, wall-mount or hanging type along with 32 timezones and automatic day-light savings adjustment facility.

Laboratory spray dryer is used for safe, fast and efficient spray drying of aqueous and organic solutions.

Spray drying is a speedy, time saving and gentle method of obtaining even the smallest quantities of substance in power form. The very short residence times and the cooling effect resulting from evaporation make it possible to process even temperature sensitive products in a gentle manner. If the use of organic solvents is involved, the thermal load is reduced to a minimum. Many other processes can also be completed in a single stage like: Modification of particle size, agglomeration of nanoparticles, drying suspensions, particle coating, immobilization of liquids and solid materials in a matrix and manufactures of microcapsules

Ideal Cures Pvt Ltd Mumbai, Maharashtra Tel: 022 - 4268 8700 Fax: 022 - 4268 8713 Email: info@idealcures.co.in Website: www.idealcures.co.in

Essae Teraoka Ltd Bengaluru, Karnataka Website: www.essae.com

Aero Therm Systems Pvt Ltd Ahmedabad, Gujarat Tel: 079-25890158 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Symmetrical gravimetric analyser The model SGA100 symmetrical gravimetric analyser is a continuous gas flow adsorption instrument specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version) and 250°C (high temperature version), at an ambient pressure. This gravimetric analyser is available in a size of 18”width x 30” height x 20”diameter with a weight of 125 lbs.

The symmetrical gravimetric analyser finds applications in pharmaceuticals, chemicals, drugs, food products, paper, fibres, powders, carbon, catalyst, etc.

Smart Instruments Company Thane, Maharashtra Tel: 0251-2801123, Mob: 09323509969 Email: smartins@vsnl.net Website: www.smartinsrument.com

Helix flexible screw conveyor The helix TM flexible screw conveyor has only one moving part.

The conveyor can be disassembled in less than 20 minutes for cleaning and maintenance.

It has upto 80 feets of achievable length.

The company provids wide range of auger style and sizes ranging from 2-8 inches in diameter. The product follows stringent USDA standards and is 3A certified. It is one of the most economical conveyor which can be used in many applications.

Hapman Systems Pvt Ltd Vadodara,Gujarat Tel: 0265 – 2517505 Email: info@hapman.in Website: www.hapman.in

Products Compact cooling centrifuge These compact cooling centrifuge model CM-8 Plus is suitable for routine sample analysis in medical, hospital, pathology and institutional laboratories. With a wide choice of rotor heads and adaptors, this unit is truly versatile. The brushless induction motor with frequency drive ensures gentle start and has CFC–free refrigeration system. It has motor overload protection, gas hinge to prevent falling of door and emergency lid lock release.

Remi Elektrotechnik Ltd Mumbai – Maharashtra Tel: 022-40589888 Mob: 09820627422 Email: sales@remilabworld.com Website: www.remilabworld.com

Glass prefillable syringe Prefillable syringes in sterile tub packs range from 0.5 ml to 5.0 ml with a variety of options and customisations.

They feature 0.5 ml with luercone/luer lock or staked needle, 1.0 ml long with luercone/luer lock or staked needle, 1.0 ml std, 1.25 ml with luercone /luer lock or staked needle, 2.25 ml with luercone/luer lock or staked needle ½” only and 3.5 ml & 5.0 ml with luercone/luer lock. Some of the options available are 0.5 ml & 1.0 ml long offered in 100 & 160 nest pack, bulk pack and nested rubber plungers, flexible and rigid needle shields (L-1/2”/5/8”/1”). The syringes are available in sterile and non-sterile form. They comply with international standards.

Schott Kaisha Pvt Ltd Daman Tel: 260 -2221192, 2220378, 2221047 Mob: 09978444241 Email: anil.narvekar@schott-kaisha.com

Sterilisation and depyrogenation tunnel AX / VX series tunnel is specially designed for ampoules and vials with various capacities. The tunnel is energy efficient and suitable for online production in conjunction with washing and filling machines. The receptacles are treated with sterile air through entire travel for thermal treatment. It features a control system, data recording facility and infeed/outfeed chutes. Sterilisation and depyrogenation is based on 3 Log reduction cycle at 296.4° c.

Also present is programmed cycles for auto/manual operation, shutdown and temperature mapping. Some of the optional features are: sleep mode during non-productive hours, cool zone sterilisation before start-up, separate cooling module for cooling zone air re-circulation.

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Venera Biotech Systems Pvt Ltd Pune, Maharashtra Tel: 251 - 2552993 Fax: 251 - 2569695, 2559695 Email: sales@venera.in, venera@vsnl.com Website: www.venera.in

Water bath This equipment offers superior temperature accuracy, rugged construction with minimum heat loss. Pump circulation flow gives maximum uniformity of temperature.

Water bath are used for incubation in water media, immersion requirements, external circulation to spectrophotometer, jacketed glassware, etc. They are also used for heating of solution / liquids in a jar flask and many other applications in the field of research, development, production and quality control.

Sarbi Mumbai, Maharashtra Tel: 022-26049538 Email: sarbi1@vsnl.com Website: www.sarbi.com

Mills and microniser PSL’s contained microniser mill/air jet mill glove box isolators are innovatively designed by expert process engineers for size reduction of active ingredients. Total mill adaptation can be provided within the glovebox isolator solutions. PSL’s contained microniser mill/air jet mill glove box isolators feature total containment gloveboxes/isolators while milling compounds along with a controlled and safe environment. All equipment can be purged with nitrogen to prevent dust explosions and can achieve less than 1% oxygen. Safety review includes nitrogen protection system for dust explosion risks, sampling methods include integration of online particle size analysers, 3D models and full scale mock-ups are available and it has assured containment to nanogram levels.

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PSL India Mumbai, Maharashtra Tel: 022 - 28908232 Email: salesindia@powdersystems.com Website: www.powdersystems.com

Fluid bed dryer bag A variety of fluid bed dryer (FBD) bags are available.

The usage of antistatic cloth in the preparation of these bags overcomes the limitations posed by the carbon loaded epitropic yarn.

It is independent of the air humidity, is chemical resistant, non brittle and wash-proof. It can withstand continuous temperature of 450°C in presence of oxygen and upto 550°C without oxygen.

N. K. Filter Fabrics Pvt Ltd Mumbai, Maharashtra Tel: 022-25786870, 25786927, 25794161 Fax: 022-25784400 Email: sales@nkfilter.com Website: www.nkfilter.com

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Products

Digital test gauge The digital test gauge AccuCal Plus is ideal for pressure measurement and for calibrating p r e s s u r e transmitters, switches and gauges. Accu-Cal Plus digital test gauge offers outstanding accuracy, resolution and stability for pressure measurement and calibration requirements. It is used extensively in process monitoring and control industry. It is housed in waterproof casing of polished stainless steel and rated IP65/NEMA4. Accurate stainless steel pressure sensors offer models to cover from vacuum up to 10,000 psig with accuracy up to 0.05% of full scale. It provides numerous user-configurable features including adjustable sample rates, dampening, tare, custom engineering units, minimum/ maximum and password-protected field calibration. A five digit rotating backlit display with oversized digits, 20 segment bar graph and high contrast provides superior resolution and excellent readability in poor

light conditions or bad viewing angles.

Temperature compensation circuitry and multi-temperature calibration provides outstanding accuracy over a temperature range of 0 to 50° C. Cole-Parmer India Pvt Ltd Mumbai, Maharashtra Tel: 022-67162209 / 2222 Fax: 022-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Fast dissolving coating Aqueous film coating system features low weight gain and it is a ready-touse dispersion which makes way for nonrequirement of any formulation step. It provides a higher level of reconstitution, up to 20%, faster coating process which reduces the energy and cost of production. Rapid rupture of coated film promotes early exposure of core to dissolution medium and results in reduction in the time

Modern Pha rm a | 1-15 July 2013

duration between administration and onset of action of API. It improves the stability of the coated finished tablets/ granules/pellets. It is available in transparent and easy addition of colours and opacifier. Required coating weight gain will be between 1.0 – 1.5 % w/w.

Moisture barrier property will require higher percent of weight gain depending upon the nature of API and shape/size of the core.

per cent efficacy. The portable fogger machine is tested for droplet size of aqueous formulations in sub-microns.

It generates droplet size in sub-microns and is approved by nuclear division of BARC, nuclear power stations and is patronised by leading hospitals and pharmaceutical industries. The machine comes with a 5 ltr capacity tank made out of best grade disinfectant tank & wetted parts.

Ideal Cures Pvt Ltd Mumbai, Maharashtra Tel: 022-42688700 Fax: 022-42688713 Email: info@idealcures.co.in Website: www.idealcures.co.in

Gouri Engineering Pvt Ltd Navi Mumbai, Maharashtra Tel: 022-27701285 Email: gouriengg@vsnl.com

High containment filter dryer Aerosol generator The aerosol generator (fogger machine) is used for sterilising air in the production shops of pharma, food, biotech and healthcare industry.

This fogger machine takes care of 5,000 cu ft volume in single fill giving 100

PSL’s aseptic/sterile filter dryers are designed and built to meet the strict manufacturing requirements necessary for aseptic/sterile processes.

These filter dryers utilise gas lift-off mechanical seals, unique offloading designs and have CIP (cleanin-place) and SIP (steam-in-place) capabilities. It features internal dust collector design for higher product yield and ease of cleaning. Minimum solvent volumes beneath mesh and direct heating tiltable filter dryer options are available.

It provides highly efficient drying due to unique underplate heating system.

Reflux cleaning can typically achieve less than 2.5 ppm. Tapered filter plate and seal design provides minimum product retention, differential mixing agitator achieves homogeneity and uniformed drying even with difficult cakes.

PSL India Mumbai, Maharashtra Tel: 022-28908232 Email: salesindia@powdersystems.com Website: www.powdersystems.com

Moist shield coating system

Exposure of drug to environmental moisture may lead to degradation of drug. In such cases a moisture barrier coating is of great value to improve the shelf life of the drug. Moist shield coating system is a blend of polymers, plasticizers, pigments, opacifiers and other excipients which could be used with organic or hydro-alcoholic systems to give protection against atmospheric moisture. The recommended weight gain is 4%. The coating does not have any effect on the disintegration or dissolution time of the dosage form.

It provides complete protection against atmospheric moisture, customised formulations to suit the requirements, guaranteed batch-to-batch colour uniformity, better film adhesion with sharp logo definition and no need for specialised packaging of moisture sensitive drugs.

Products Ideal Cures Pvt Ltd Mumbai – Maharashtra Tel: 022-4268 8700 Fax: 022-4268 8713 Email: info@idealcures.co.in Website: www.idealcures.co.in

Oil aerosol filter tester It consist s of PAO-4 , DOP, DEHS Aerosols.

Technical specifications a re 0.3μ m mass mea n diameter (MMD), 0.18μm count median diameter (CMD), grav imet ric sta nda rd deviation (GSD) < 1.6, 20 to 150 mg/m3 concentration. It is a solid state photometer with dynamic range of 0.0001 to 200 mg/m3. Penetration value is displayed utilising 5 discrete decades. Accuracy is ±1.0% full scale for the range in use, repeatability is ±5.0% full scale reading for the range in use and sample f low rate is 10 to 100 SLPM (0.35 to 3.53 SCFM).

Pressure specifications are accuracy ±0.5% of full scale, range 0 to 100 mm of water column (0 to 3.94 inches w.c.), efficiency 0.0005% to 99.9995% and f low rate 10.0 to 100.0 SLPM (0.35 to 3.53 SCFM). Dimensions are 107cm H x 71cm W x 86cm Deep (42”H x 28”W x 34”Deep) and weight 102 Kg (225 lbs.) Power requirement is 115 VAC, 50/60 Hz, 2 Amps (230V optional).

MeasureTest Corporation Mumbai – Maharashtra Tel: 022-23645282 Mob: 09869012701 Email: measuretest@yahoo.com Website: www.measuretest.com

Reaction vessel

These industrial reactors are fabricated to accuracy using qualitative material and are constructed either in M.S. or S.S. These vertical reactors are provided with different capacities ranging upto 25KL and comprise of the following construction elements: sturdy construction, leak proof and durable finds application in various industries such as pharmaceutical, fertilizers, food and dairy industries, petrochemical industries, pulp and paper industries, dyestuff and chemical engineering industries. The various types of vessels available are jacketted reactor, limpet coiled reactor and internal coil reactor.

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Aries Engineers Thane - Maharashtra Tel: 022-28555751 Fax: 022-28555776 Mob: 09323649078, 09930992671 Email: ariesengineers@yahoo.com, info@ariesengineer.com Website: www.ariesengineer.com

indicated within the accuracy +/-0.15°C and humidity better than +/-2% RH. A graphical display screen reads and displays the data at respective channel.

This scanner is designed to monitor and display up to 16 channel for each of temperature, humidity, RTD, thermocouple as well as any digital inputs. A graphical display is provided to indicate the current process value of temperature and humidity.

Multi-channel scanner The Enviro scanner is fully valid table and designed for regulated industries. The specification incorporated serves every simple and critical process control applications of the industry. It is known as an e-scan system which is suitable for continuous monitoring and recording of temperature or humidity at 16 different locations, eliminating the need for number of individual temperature or process indicators in turn saving the cost. The temperature is

Enviro Technologies Thane - Maharashtra Tel: 022 - 64646500 Email: ankit.s@enviroworld.in Website: www.enviroworld.in

Track and trace system Track and trace system is powered to create a complete identification and data verification solution for labels on pharmaceutical medical device packaging and healthcare serialisation. It reads 2-D and 1-D barcodes: Data Matrix, GS1128, GS1 dataBar, securPharm and Pharmacode. It can verify correct ID

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code contents, including compliance with the GS1 Healthcare data standard, supports FDA 21 CFR Part 11 validation compliance with change tracking, double blind and secondary authentication, provides data matrix mark quality assessment during production to detect changes in print quality, verify the accuracy of printed text & skew, detect label misalignment & skew and supports bundle aggregation.

Cognex Sensors India Pvt Ltd Pune - Maharashtra Tel: 020- 40147840 Fax: 020-66280011 Email: sisd.support.asia@cognex.com Website: www.cognex.com

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V blender V blender is an ideal mixer for cream, ointment and paste.

All parts are made of stainless steel and are highly polished. The blender can produce a homogeneous mixture. Technical specifications are 43 Kg weight, 68 kg gross weight, 660mm x 482mm x 630mm dimension and electrical specifications 0.25HP, AC, 230V, 50Hz, 3Ph.

Modern Pha rm a | 1-15 July 2013

with set measuring rate. It comes with a battery life of 3-5 years. The data logger is housed in stainless steel, PEEK. It has IP68 protection class/housing for pharmaceutical industries.

Ambetronics Mumbai - Maharashtra Tel: 022-28371086 Email: ambetronics@vsnl.com Website: www.ambetronics.com

Jay Pharma Equipments Mumbai - Maharashtra Tel: 022 - 32155790 Email: jkpharm1@gmail.com Website: www.jaypharmaequipments.com

Octagonal blender Electric blanket

Cronimach Machinery Ahmedabad - Gujarat Tel: 079 â&#x20AC;&#x201C; 25861418 Email: info@cronimach.com Website: www.cronimach.com

Temperature data logger The data logger for pharmaceutical industries has measuring capacity ranging from -35-80°C, accuracy of ¹0.5°C and resolution of 0.1°C with sensor Pt1000. The measuring rate is selected from 1 min to 8 hours. It can store 4,000 value data in memory. The measuring mode is automatic with loop, start/stop or start

and VFD. Applications include blending of dried granules for tablets and blending of dry powders for capsules. Documentation like DQ, IQ, OQ and FAT is provided with the machine.

Octagonal blender features discharge output via. butterfly valve, safety guards provided with limit switch interlocked to motor to ensure safe operation, bump- less rotation.

All contact parts are made of SS 316 as per GMP standard. It has zero retention design. Internal finish conforms 220 grits to 320 grits, outside mat finish180 grits.

Charging drum arrangement with mechanical / hydraulic trolley is provided. Other features include safe earthing systems, optional accessories/ attachments, flame proof construction, PLC with MMI

Aristocrat electric blankets are waterproof, shockproof, autocut, soft underlay to provide constant slow motherly warmth. It is a relief for the patients of asthma, gout-arthritis, backaches, bodyaches & pains, patients of diabetes, low blood pressure, and the aged alike. These blankets supplement the much needed body energy and are useful for senior citizens.

Chemical resistant diaphragm vacuum pump Chemical resistant diaphragm pump are the best suited oil free vacuum option for laboratory and pilot scaled application. Typical applications for chemical resistant diaphragm pumps include evacuating chemically aggressive gases and vapours from equipments such as rotary evaporators, vacuum drying cabinets and centrifugal concentrators. Most importantly, diaphragm pumps are oil-free, for vastly reduced service demands compared with oil-sealed pumps. They eliminate the water waste of water-jet aspirators, and the contaminated waste-oil disposal of rotary vane pumps. The diaphragms are available in various options of materials like EPDM, neoprene, viton and teďŹ&#x201A;on coated neoprene rubber. These vacuum pumps are available in the range of 15 lpm to 33 lpm and they generate a maximum vacuum of 30Torr. Chemical resistant vacuum pumps are also supplied with 3phase ďŹ&#x201A;ame-proof motors.

Sri Vishnu Pumps Mfg Co Thane - Maharashtra Tel: 022 - 28458372 Fax: 022 - 28457073 Email: vishnupump@rediffmail.com Website: www.minivacpumps.com

Medico Pharmaceuticals Processors Amritsar â&#x20AC;&#x201C; Punjab Tel: 0183-2258586 Mob: 09356000059 Email: info@medico.co.in Website: www.medico.co.in

The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of

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Apollo Phar Ranbaxy macy stops drugs sale of Apollo

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Generic injectables On a growth trajectory

Parker Ha

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Are strict regulatory compliances responsible manufacturersâ&#x20AC;&#x2122; for supply shortag e and withdrawal from injectab les?

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According movement described scopy, nanop QNM ring d under in diame on the sources, to some The excipi â&#x20AC;? can be article the circulates approach how this detaile ter. They tracke ents such for imple 45-day time period industry throug used may also d administratio hout the body, d as it mentation as polym growing help scienti imaging encap to formulate DPCO of new ceilingis short, concerns n. This can after oral the nanop ers, witho sts addres sulating 2013 becam around in the medic s effects drugs ut be made article 15 May, â&#x20AC;&#x2DC;nanot e effecti price. possib al world when directl may exhibit undes - radioactiveattaching any 2013 microscopic oxicologyâ&#x20AC;&#x2122;, the ve from fluorescent le order bringi and replac y absorb gut wall. ired drug labels and build-up particles ed the ed throug Scient or of if by using in people Prof. Kuma loaded 1995 regulation, ng 348 drugs h the nanoparticle ists are keen â&#x20AC;&#x2122;s tissues the real r, whose accumulation nanoparticles. under price has to as . teamâ&#x20AC;&#x2122;s been discov -based comp In particu previously, effects on published research er, areas ared to drugs have of nanop lar, article in the patients said, â&#x20AC;&#x153;Nano 74 drugs on the articles in can adverse market and cause more basis of technologyâ&#x20AC;&#x2122;s journal PLOS ONE, specific price of detecting be identified easily, has the power harm than in particular, if they nominal role in drug a drug. causes of Till now, good in to transfo delivery condition are given â&#x20AC;&#x2DC;tissue stiffne thereby rm the about what very little has some cases. medici ssâ&#x20AC;&#x2122; â&#x20AC;&#x201C; a including linked to variety been known so. The good nes over the way patients happens cancer. circulate of diseas thing about next decade or es, throughout after nanoparticle Addit nanomedicine if they s atomi ionally, recent the body s is patien raise any c force studie and safety issues t. Previo it is possib microscopy have s using usly, it for le shown the was necess that, malignant to distinguish ary for betwe and malign the basis ant tumou en nonof their relative stiffne rs cells, on ss.

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