Express Pharma 16-30 November 2013, Part I

VOL .9 NO.2 PAGES 186

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CONTENTS

NOBODY’S CHILDREN

Vol 9 No.2 NOVEMBER 16-30, 2013

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

MARKET

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

33

SPAIN-BASED GRIFOLS TO ACQUIRE NOVARTIS BLOOD TRANSFUSION DIAGNOSTICS UNIT

34

LIFECELL IN SECOND PHASE OF EXPANSION AT GURGAON CENTRE

42

HEALTHCARE BRAND SUMMIT ON DEC 5

44

DIA INDIA HOSTS 8TH ANNUAL CONFERENCE

46

6TH NASAL AND PULMONARY DRUG DELIVERY SYMPOSIUM HELD IN MUMBAI

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro

Countries have been marking Children’s Dayfor manyyears but until veryrecently,there was hardlyanydrug development focused on the paediatric demographic.Safetyconcerns are nowforcing pharmaceutical companies to paymore attention. | P24

Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P167: RESEARCH The search for safer, better diabetes medication

P170: CLINICAL UPDATE Bone Therapeutics’ phase III osteonecrosis trial with PREOB hits a new milestone

P MEC SPECIAL

74

ROBO TRICKS

78

‘PHARMA COMPANIES AND EQUIPMENT VENDORS SHOULD SHARE A SYMBIOTIC RELATIONSHIP’

80

SEERPHARMA AND LABNETWORX LAUNCH TRAINING PARTNERSHIP IN INDIA

P173: BIOPH New ways to grow

P183: APPOINTMENT Thomas Temple elected Chairman of USP Board of Trustees

P184: NEW COURSE Biocon unveils Biocon Academy

81

TURN TO PAGE 45 TO FIND SPECIAL DEALS

ATE: SPEARHEADING SUSTAINABLE SOLUTIONS

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

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

EDITOR’S NOTE

New paths to success

T

he first fortnight of November saw the Drug Controller General of India (DCGI) crack down on Mumbai-based Sun Pharma and GuruFcure based in Puducherry.

While the DCGI asked Sun Pharma to stop all clinical research activity at its bio-analytical laboratory in Mumbai, GuruFcure was slammed for falsifying data in its applications for new fixed dose combinations. Sun Pharma is reportedly working to resolve the issue, citing an “ambiguity in guidelines” as the reason for this censure while there is no word yet on GuruFcure’s response to the DCGI order.

The point is, India's regulator seems to have realised that its own credibility was at stake if it did not crack the whip across the pharma value chain.

The two companies represent two very different, yet connected, facets of the Indian pharmaceutical industry. In terms of market cap, Sun Pharma is at the top of the heap while GuruFcure is one of many contract manufacturers.

The latter may be much lower on the value chain but nevertheless lists quite a few of Sun Pharma's peers as its clients. Abbott is the only MNC on the list and has since distanced itself from its former supplier as has Glenmark. Companies ranging from Alkem Laboratories, Hetero Drugs, Intas Pharma, JB Chemicals and the like are mentioned on GuruFcure’s client list on its website.

Pharma companies need to heed the warning as

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22 EXPRESS PHARMA November 16-30, 2013

If necessity is the Mother of Invention, then adversity must surely be the Father of Re-invention

the crackdown is not likely to be a passing phase.

The double whammy of increased spends on better manufacturing systems and lower growth will be a strain on balance sheets in the short term, but will hopefully fire the imaginations of pharma leaders.

To help companies navigate this complex labyrinth of regulations while coping with extremely tough market conditions, we asked experts for their insights on how companies can carve out new paths for success. As author Johnny Flora put it, ‘If necessity is the Mother of Invention, then adversity must surely be the Father of Re-invention.’

Thus the cover story of our CPhI India special section (API industry at crossroads: pages 50-63) has global experts give their take on what API manufacturers in India should do to become the No 1 API producer in the world. Similarly, the cover story in our PMec India section, (Robotricks: pages 70-74) advocates the use of robotics to improve quality and in the Indian pharma industry while the experts in the BioPh India section (New ways to grow: pages 174-177) look specifically at bio-betters and better regulation as the paths to success. We are sure that by this time next year, when Express Pharma will be in its 20th year, the Indian pharma industry will have bounced back higher and bigger than ever before.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

Read it.

Don't Scan it.

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MARKET

BILLION MILLION CHILDREN UNDER THE AGE OF FIVE DIED IN 2012

NOBODY’S CHILDREN Countries have been marking Children’s Day for many years but until very recently, there was hardly any drug development focused on the paediatric demographic. Safety concerns are now forcing pharmaceutical companies to pay more attention.

BY USHA SHARMA

A $85 B I L L I O N Value of the paediatric drugs and vaccines market by 2017

24 EXPRESS PHARMA November 16-30, 2013

s per the 2011 census, India has around 158 million children in the age-group 0-6 years, with 20 states and union territories accounting for over one million children in this age group. This age group makes up approximately 13 per cent of the total population of the country, and while there has been a slight decrease in the last decade, India is nowhere near developed nations like the US where the proportion of children has shrunk and is predicted to shrink faster over

the coming decades. India thus represented a booming market for companies targeting this age group.

Shrinking or not, the younger age group represents the future of any country and indeed this planet but in terms of medicines, this demographic has been ignored. Shashank Sandu, Managing Director, Sandu Pharmaceuticals reveals the facts, “Globally nearly nine million children under five years of age die every year, with pneumonia, diarrhoea, and neonatal causes being the major killers.”

Hitesh Gajaria, Partner, KPMG presents the current Indian prescription-based paediatric drugs market and says, “In the Indian context

the market share of paediatric drugs is a relatively minor portion of the pharma pie (less than10 per cent). While a few companies have specialised product portfolios for child care, most big players manufacture few or no drugs specifically for this demographic.”

There is no doubt that the potential exists. For instance, globally, the paediatric drugs and vaccines market is growing at a rate of four to six per cent annually and is estimated to reach $85 billion by 2017.

The US represents the largest market for paediatric drugs and vaccines while the EU follows. Dr Ajit Dangi, President and Chief Executive Officer, Danssen

Almost all the paediatric drugs are originally developed for adults (barring few vaccines) and the results are extrapolated to children or often used as off label.

This strategy makes safety a major concern for medicines for paediatric use as children are not small adults Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting

13%

158 MILLION

children are in the age-group 0-6 years in India as per the 2011 census

PAEDIATRIC DRUGS SHARE IN INDIAN DRUG MARKET

LESS THAN

10%

Today, we cannot ignore the fact that promotion of appropriate and safe drugs in children is the global need of the hour Shashank Sandu Managing Director, Sandu Pharmaceuticals

Continued on Pg 28

MARKET Continued from Pg 25 Consulting informs, “The most over prescribed drug for children globally, Novartis’ brand Ritalin (methylphenidate HCl) is prescribed for Attention Deficit Hyperactivity Disorder (ADHD ) and 90 per cent of global sales come from the US. It is estimated that 11 per cent school going children in the US are diagnosed as suffering from ADHD. The total US sales of methylphenidate crossed $1.4 billion in 2012.”

It is projected that future growth in the paediatric drugs market is likely to be driven by the Asia-Pacific markets where the market is estimated to grow at a compound annual growth rate (CAGR) of 11 per cent.

In India, the paediatric drug market is being tapped by both multinational as well as domestic pharmaceutical players. Multinational pharma companies like Pfizer, Johnson & Johnson (J&J), Allergen Abbott Laboratories, SanofiAventis, GlaxoSmithKline, Merck, Merck Serono, Novartis, Novo Nordisk, Allergan, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Nestle, F Hoffmann-La Roche, and UCB Pharma have a presence in India and among Indian companies Lupin, Dr Reddy’s Laboratories and Cipla are the largest players with allopathy drug portfolios for the

28 EXPRESS PHARMA November 16-30, 2013

paediatric population.

Historically speaking, India does not have a tradition of allopathic drugs. Physicians following the traditional medicinal sytem, called vaidyas, were the main source of treatment. As time passed, society’s needs changed and the allure of quick relief made people switch to allopathic drugs.

However, old habits die hard and parents still prefer to opt for traditional medicines especially when their children are concerned as they are perceived to be safer and without severe side effects. A handful companies like Sandu Pharmaceuticals, Himalaya, Dabur and Baidyanath have captured this market with varied range of paediatric herbal formulations. Feeding into this perception Sandu informs, “Considering the safety aspects, herbal drugs and nutritional supplements are well-accepted in children, one of the most sensitive population in the clinical set-up.”

To some extent, this reasoning was justified as most medicines had not been tested on children during clinical trials. Clinical practitioners resorted to the practice of reducing the dose of the adult medicine based on the body weight and age of each child patient.

Referring to this reality,

seven per cent.”

Wide therapeutic area

The Government of India should develop a prioritised list of diseases for children and make a take long-term projects. These projects can run over a period of three to five years with public and private partnerships where sufficient amount and resource are executed in drug discovery, clinical trials and new solutions which can be later brought to the world Dr R B Smarta

Paediatric trials also face logistical issues from a patient recruitment viewpoint.

Moreover, paediatric trials rely heavily on funding provided by the government or other non-profit organisations dedicated to child care. This is not the case in adult trials which receive most of their funding f rom industry players

Managing Director, Interlink Marketing Consultancy

Hitesh Gajaria

Sandu says, “Over the past few decades, experts in clinical research were of the view that we must protect children from research. Now there is a

gradual shift in the focus that we must protect children through research. Global market for paediatric hormones is forecast to grow at a CAGR of

Partner, KPMG

Among many categories of paediatric medicines, respiratory, anti-infectives, central nervous system (CNS), dermatologicals, anti-diarrhoeals as well as vaccines have a large share. J&J is one of the few MNCs which has developed a slew of over dozen preparations for children under an umbrella brand.

Giving details, Dangi says, “TYLENOL has basic ingredient acetaminophen (paracetamol) ) with combination with other safer drugs for ailments like cold and cough, fever, allergy, pain and aches, flue etc.

This is one of the most successful paediatric franchises in the US; although of late it has received flak from the US FDA for several quality issues resulting in many product recalls.”

Since children cannot swallow solid dosage forms like tablets and capsules, most oral paediatric preparations have to be developed as oral liquids or dry syrups. Simultaneously if a particular medicine has a discernible smell and or unpleasant taste, they are less likely to be accepted.

If it falls in delivering substantial relief as well, then children will strictly refuse to take medicines.

Dangi cautions, “This poses a challenge as most

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MARKET drugs are bitter or salty in taste and unless their taste is masked and the preparation made palatable, patient acceptance and therefore compliance becomes a problem.

Illustrating with an example, he continues, “Metronidazole which is an anti-amoebic, has an extremely bitter and metallic taste and hence to develop it into a paediatric oral dosage form the salt has to be converted in to an ester, metronidazole benzoate, which is bland in taste and hence can be given a flavour of choice.”

The key therapeutic areas for paediatric drugs in India are gastrointestinal (GI) disorders, HIV, metabolic disorders, asthma, anti-pyretics, nutritional supplements etc.

In India, Cipla has a range of approximately 90 paediatric products in different formulations/ dosage forms. It has also developed Deferiprone, the world’s first oral iron chelator and Deferasirox for thalassemic patients. For paediatric HIV, it has developed a triple drug combination (Nevirapine + Stavudine + Lamivudine) in dispersible form. Lupin also has strong portfolio in diabetology, dermatology, and asthma.

Gajaria feels, “Growth in the segment is largely expected from therapeutic segments like - paediatric vaccines and hormone therapy

30 EXPRESS PHARMA November 16-30, 2013

KEY FACTS ■

■

■ ■

drugs as well as from respiratory and allergy drugs, CNS drugs, and anti-infectives. Although anti-infectives constitute a larger portion of the paediatric market share. The domain has been widely researched and contraindications / reactions are well documented. Newer areas such as paediatric hormones and CNS drugs for use in children are relatively under-researched presently. It is therefore important that information on drugs therapies and reactions and in these segments are well studied and documented.”

Along with the above mentioned therapeutic areas, indepth research could uncover more areas of unmet medical need in this demographic which could be tapped by In-

More than half of these early child deaths are due to conditions that could be prevented or treated with access to simple, affordable interventions.

Leading causes of death in under-five children are pneumonia, pre-term birth complications, birth asphyxia, diarrhoea and malaria.

About 45 per centof all child deaths are linked to malnutrition.

Children in sub-Saharan Africa are about over 16 times more likely to die before the age of five than children in developed regions.

Source: WHO

dian pharma companies. “Dehydration, calcium deficiency, worms and malnutrition are the areas of concern,” informs Sandu.

Thrust drives growth A drug before it reaches to the market takes a long time to pass through the research and development centre and through various regulations.

There is a lot of research going on globally on adults but there is limited research being carried out in the paediatric arena. Dangi highlights, “Almost all the paediatric drugs are originally developed for adults (barring few vaccines) and the results are extrapolated to children or often used as off label. This strategy makes safety a major concern for medicines for paediatric

use as children are not small adults.”

While informing about the total conducted clinical trials in India, Gajaria outlines, “A study carried out to gauge the number of trials carried out between 2006 -2011 revealed that while 60 per cent of the diseases for which drugs were tested could be attributed to children, only 12 per cent of the trials conducted were in fact for paediatric drugs.”

Dangi explains, “For instance, Aspirin which is in use for over a century as a pain killer needs to be used for children with extreme caution as it causes Reys Syndrome (swelling in the lever and brain ) and hence is contraindicated. However, such conversions can often cause bioavailability and stability

problems in some cases. Development of paediatric dosage forms, therefore, is a significant R&D challenge.”

In December 2007, World Health Organization (WHO) published its first ever model list of essential medicine list for children with more than 200 medicines, including HIV/AIDS treatment, vaccines, anaesthetics, hormones, vitamins, and minerals. “This serves as a reference for countries to develop national essential medicines lists, according to their specific public health needs.

Indian Academy of Paediatrics (IAP) Drug Formulary is one of the three exclusive paediatric drug formularies in the world. The array of medicines cover mostly the paediatric diseases related with skeletal system, CNS, immunity, respiratory system, endocrine system, skin, infectious diseases and growth milestones. there is still a long way to go in terms of safety and efficacy,” emphasises Sandu.

Pointing out about the clinical trials adverse drug reactions and its data availability, Dr RB Smarta, Managing Director, Interlink Marketing Consultancy comments, “There is no sufficient data available on an adverse drug reaction across the globe. The emerging markets are likely to require paediatric drugs

MARKET and vaccines in various therapeutic areas. With growing demands medical practitioners need to be well versed with the knowledge of prescribed dosages. This will be only possible if practitioner looks at the pharmacokinetics and pharmacodynamics and prescribes the right dosage.”

Gajaria notes on why there is less research being carried in the paediatric segment saying, “This could be attributed to the fact that there are controversies surrounding paediatric trials from ethics and regulatory points of view.

Paediatric trials also face logistical issues from a patient recruitment viewpoint. Moreover, paediatric trials rely heavily on funding provided by the government or other non-

Several regulations like Best Pharmaceuticals for Children Act, Paediatric Drug Research Equity Act, Food & Drug Administration Modernisation Act, have been enacted to standardise and streamline the paediatric drugs market profit organisations dedicated to child care. This is not the case in adult trials which receive most of their funding from industry players.”

Sandu briefs, “For several years, physicians were paralysed with lack of information and options for prescribing treatment to patients in the paediatrics market. Many

were compelled to rely on offlabel prescription of drugs, as the market was deprived of approved drugs in many segments. This also created worry among physicians and paediatricians pertaining to the safety and efficacy of these drugs. We, being firmly footed in ayurvedic medicines for over a century, have fo-

cused our paediatric range.”

Regulations The IAP Drug Formulary contains IAP recommendations for 555 paediatric illnesses contributed by respective sub speciality chapters of IAP, 613 monographs of drugs used exclusively in paediatric therapeutics and details of

1099 brand names of drugs available in India. Several regulations such as Best Pharmaceuticals for Children Act (BPCA), Paediatric Drug Research Equity Act (PREA), Food & Drug Administration Modernisation Act (FDAMA), have been enacted to standardise and streamline the paediatric drugs market. Bodies like the FDA and EMA have adopted new regulations that encourage and incentivise companies to carry out paediatric trials. Sandu shows concern, “Today, we cannot ignore the fact that promotion of appropriate and safe drugs in children is the global need of the hour.”

Gajaria highlights, “The International Conference on Harmonisation (ICH)

31 EXPRESS PHARMA November 16-30, 2013

MARKET

LEADING CAUSES OF DEATH IN POST-NEONATAL CHILDREN: RISK FACTORS AND RESPONSE Cause of death

Risk factors

Prevention

Treatment

Pneumonia, or other acute respiratory infections

Low birth weight, Malnutrition, Non-breastfed children Overcrowded conditions

Vaccination Adequate nutrition Exclusive breastfeeding Reduction of household air pollution

Appropriate care by a trained health provider Antibiotics Oxygen for severe illness

Childhood diarrhoea

Non-breastfed children Unsafe drinking water and food Poor hygiene practices Malnutrition

Exclusive breastfeeding Safe water and food Adequate sanitation and hygiene Adequate nutrition, vaccination

Low-osmolarity oral rehydration salts (ORS) Zinc supplements

Source: WHO

Guideline of the ICH distinguishes between five developmental stages: pre-term newborn infants, term newborn infants, infants and toddlers, children, and adolescents.

Such errors could result in drug toxicity in children and may also cause many adverse drug reactions like allergies.

Using children to test drugs that are not formally approved comes with its own share of ethical issues. Moreover, since the protocol behind paediatrics trials is not standardised in most countries, these trials carry inherent risks. ” Sandu informs about precautionary measures which need to be taken in order to promote clinical trials in children segment, “All countries should establish national and regional monitoring systems

32 EXPRESS PHARMA November 16-30, 2013

for the detection of serious adverse reactions to medicines in children. When such reporting systems exist, it is crucial that manufacturers follow up on adverse reactions to their products once they are on the market.”

Compared to allopathy drugs, herbal medicines are perceived to result in less side effects and to be safer for paediatric clinical trials. Sandu opines, “Our experience is that it is comparatively easier to enrol paediatric patients in a trial of herbal medicines as the parents themselves believe that herbal drugs are safe and I think they are right to a certain extent.”

Government programmes and initiatives WHO in December 2007 launched a campaign called

“Make medicines child size” which raised awareness and stimulated action to improve the availability of safe, effective, and quality medicines for children. Sandu emphasises, “Safety should be of the topmost priority while treating our children.”

Smarta mentions, “Every country has a different set of concerns. The Government of India should develop a prioritised list of diseases for children and take long-term projects. These projects can run over a period of three to five years with public and private partnerships where sufficient amount and resources are spent in drug discovery, clinical trials and new solutions which can be later brought to the world.”

Realising the fact Dangi informs, “Given the fact that

IAP ,an official body of paediatricians has just about 20,000 members shows the dearth of professionals in this important medical field.”

He however praises the efforts being taken by the Indian government saying, “In spite of these challenges, there is one success story and that is total eradication of polio from Indian soil due to abundant availability of affordable oral polio vaccine and excellent communication strategy using celebrities like Amitabh Bachchan to spread the message nationwide using electronic media. It is hoped that the Ministry of Health emulates some of the strategies of WHO and US FDA to stimulate growth of paediatric medicines in India and replicates its success as is done in eradi-

cating polio. After all a healthy child is the future of India.”

Children are considered gifts of God and giving them a healthy life becomes the utmost wish and duty of every parent. After a long campaign driven by the research efforts of pharma companies as well as the Government's initiatives, we managed to eradicate polio from the country completely and India became a polio free nation.

Overcoming a single disease will not suffice the need as there are many areas which need equal interest from pharma companies as well as the Government. We the people will have to encourage them to work on the so far neglected category of childhood diseases. u.sharma@expressindia.com

COMPANY WATCH

Spain-based Grifols to acquire Novartis blood transfusion diagnostics unit Divestiture further enhances Novartis focus on strategic businesses NOVARTIS ANNOUNCED a definitive agreement to divest its blood transfusion diagnostics unit to Grifols for $1.675 billion. This transaction, requiring customary regulatory approvals, is expected to be completed in the first half of 2014.

“The sale of the Novartis blood transfusion diagnostics unit enables us to focus more sharply on our strategic businesses while providing Grifols with a platform for global expansion,” said Joseph Jimenez Chief Executive Officer, Novartis.

“I am pleased that the agreement with Grifols provides our associates with an opportunity to join a company that will focus on growing this business aggressively.”

Acquired in 2006 as part of Chiron, the blood transfusion diagnostics unit has formed part of Novartis Vaccines and Diagnostics.

The blood transfusion diagnostics unit is dedicated to increasing transfusion safety worldwide with nucleic acid testing, blood testing products and immunoassay reagents that detect infectious disease. Headquartered in Emeryville, California, its net sales in 2012 were approximately $565 million.

Not included in the sale is the Novartis companion diagnostics unit that is integrated into the pharmaceuticals business, nor the Genoptix business, as these are closely linked to the pharmaceuticals pipeline.

Headquartered in Barcelona, Spain, Grifols is the world’s third largest producer of plasma-derived therapies.

EP News Bureau-Mumbai

33 EXPRESS PHARMA November 16-30, 2013

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LifeCell in second phase of expansion at Gurgaon centre In talks with Haryana and Tamil Nadu state governments for PPP model

Usha Sharma Mumbai CHENNAI-BASED accredited stem cell banking company LifeCell is expanding its stem cell banking storage centre located in Gurgaon with a total investment of ` 20 crores. With the expanded centre it aims to have a capacity of 4 lakhs units. The company is targeting to finish expansion related work in the next six months while the expanded centre should be available for operation in less than a year .

Giving the rationale for the expansion Mayur Abhaya, Managing Director and Chief Executive Officer, LifeCell said, “Today competition is everywhere and with our commitment to offer services which are affordable, we recently expanded our Chennai based centre. There is still

34 EXPRESS PHARMA November 16-30, 2013

scope for future expansion.

Moving ahead, now we have planned to expand our other centre located at Gurgaon. We had invested ` 5 crores and built a capacity of 65,000 units for the same facility in its phase I. After completion of the expansion plans, the same facility will have a storage capacity of 4 lakh units. At present our Chennai facility has a capacity of 80,000 units.”

While responding on the possibility of a public private partnership (PPP) model, Abhaya revealed, “Yes we are considering PPP model. We are in talks with the Haryana state government for PPP model and our talks are presently in the early stages.

It will take another year to get conceptualised and reflected on paper. We have also approached the Tamil Nadu government because this state

government has already sanctioned ` 9 crores to another stem cell banking company for creating 3000 units and assured us that we could be an additional service provider for

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the Tamil Nadu government.”

He also stressed that the company had plans for adopting such a PPP model in other states as well. “We will first approach those states which

have less maternal mortality rates. Initially, we are considering states like Kerala, Andhra Pradesh, Maharashtra and Gujarat for the PPP model.”

The company has launched a more affordable platform for preserving umbilical cord blood stem cells for ` 19,999 with an annual maintenance fee of ` 3,500 per year. It has offered an easy monthly installments (EMIs) scheme as well and is emphasising more on creating awareness of the benefits of umbilical cord blood stem storage for the future.

According to a press release from the company, it has been used for over 25 years for more than 30,000 successful transplants world over.

Umbilical cord has been the number one source of stem cells for treatment of children in the US and Japan and um-

bilical cord banking is regarded as an essential service globally. In 2005, there were less than 25 stem cell banks worldwide, but in 2013, there are approximately 500 banks globally with one bank in almost every major country.

Laws have been enacted in the US to create awareness on cord blood banking, and financial aid is provided in countries like Singapore. India lags behind world indicators significantly with extremely low public cord blood units and lack of bone marrow donors.

Therefore, there is a dire need to address both awareness and affordability to increase adoption of stem cell banking.

Abaya indicated that LifeCell was planning to invest from the company's earning on creating awareness and promotional activities. u.sharma@expressindia.com

HEALTHCARE BRAND SUMMIT

5th - 6thDecember, 2013, Hilton Hotel, Mumbai WHO SHOULD ATTEND

WHY SHOULD YOU ATTEND The HealthCare Brand Summit 2013, will bring some of the most respected Industry Leaders, CEO’s & CMO’s from Rx, OTC, HealthCare Services,Hospitals, Diagnostics & Devices… on a single platform. Where they will discuss challenges and share their experiences.

CEO’s CMO’s Marketing & Product Managers Branding Experts Marketing Communication Solution Providers Key stake holders from Government & Regulatory Bodies

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Ranjit Shahani Novartis India

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* Subject to final confirmation

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Philips Healthcare

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Kewal Handa

Medybiz Pharma

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Lawrence Ganti Merck Serono

Dr. Nagesh Rao Ph.D. Dr. Om Manchanda MICA

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Interbrand London

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For Sponsorship Enquiries contact Samarjit Singh | +91 9811436040 | samarjit.singh@afaqs.com

Granules India acquires Auctus Pharma

Suven Life secures product patents from the US and Japan

To open a new R&D acility in Hyderabad

The patents are valid through 2026 and 2028

GRANULES INDIA has signed a definite agreement for the acquisition of Auctus Pharma, a leading API manufacturer. The acquisition process is expected to be completed in the next three to six months. Auctus has two manufacturing facilities, an API facility in the Pharmacity in Vishakhapatnam and an Intermediate facility in Hyderabad. The API facility has approvals from leading regulatory agencies including the US FDA, EDQM, Health Canada, KFDA and WHO-GMP. Auctus’ product portfolio includes twelve APIs as well as key intermediates of those APIs. The portfolio includes APIs in several therapeutic categories such as antihistaminic, antihypertensive, antithrombotic and anticonvulsant as well as other therapeutic categories.

Auctus currently sells its APIs and intermediates to customers in fifty countries. The team and assets from the acquisition will initially operate as a separate division with Granules.

Granules also announced the opening of a 10,000 sq foot R&D facility in Hyderabad. The new R&D will focus on full scale generic API development and will supplement the

36 EXPRESS PHARMA November 16-30, 2013

company’s existing R&D facility in Pune which currently focuses on sustainable technology development. “The acquisition of Auctus fits into our strategy of being a fully integrated manufacturer while diversi-

TM

2

VISIT US AT CPhI INDIA 2013, 3-5 DECEMBER 2013, MUMBAI

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fying our product portfolio by adding high-value products with significant market demand. Auctus provides Granules with a meaningful API platform with a US FDA approved site to strengthen our finished dosage division. Granules will offer value to customers since we can provide supply security all the way from key intermediates to fin-

ished dosages for these products.

We will be a market leader by implementing our operational excellence philosophy while leveraging Auctus’ regulatory approvals. In order to accelerate growth with a sustainable development engine, we have established a new R&D facility to enable Finished Dosage filings for our new APIs,” said Krishna Prasad, Managing Director, Granules India.

“The acquisition is one part of our three-prong growth strategy.

We remain committed to building on our position as a global leader for our existing products which include paracetamol, metformin, ibuprofen and guaifenesin. We will continue to strengthen our lead over others by focusing on continuous improvements and capacity enhancements in existing and new products. In addition, our team is eagerly awaiting the commercialisation of our third growth driver, Granules OmniChem, a collaboration with Ajinomoto OmniChem, a premier CRAMs manufacturer” said Harsha Chigurupati, Executive Director, Granules India.

EP News Bureau-Mumbai

SUVEN LIFE Sciences has been granted two product patents one each from the US (8470830) and Japan (5236001) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2026 and 2028 respectively.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia.

With these new patents, Suven has a total of fifteen granted patents from the US and seven granted patents from Japan. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at phase-I or phase-II. “We are pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,” says Venkat Jasti, Chief Executive Officer, Suven.

EP News Bureau-Mumbai

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Eisai starts supply of Diethylcarbamazine to eliminate lymphatic filariasis First shipment to benefit more than 6 million people in four endemic countries EISAI PHARMATECHNOLOGY & at its Visakhapatnam Plant in India in AuManufacturing has begun the free supply gust 2013, Eisai has now begun to provide of Diethylcarbamazine Citrate (DEC) 100 a steady supply of DEC tablets over a mg tablets produced at its Visakhapat- seven-year period from 2013 to 2020 for nam plant in India to the World Health distribution through WHO's MDA proOrganization (WHO). This is in line with grammes to some 250 million people livEisai’s commitment to help WHO in its ing in at-risk communities in 26 targeted global effort to eliminate lymphatic filari- countries. asis in targeted developing and emerging Eisai believes that contributing to the countries. improvement of global health and access The Pacific island nations of Papua to medicines in developing countries is a New Guinea, Kiribati, Tuvalu and Fiji form of long-term investment that conhave been confirmed as the first countries tributes to the economic growth of these to receive the initial shipment. An esti- countries. The company remains actively mated 6.25 million peocommitted to addressple living in at-risk coming overall issues in munities will benefit global health, including from mass drug adminNTDs, in order to furistration (MDA) prother increase the benegrammes.

VISIT US AT CPhI INDIA 2013, fits provided to patients Eisai is an active and their families world3-5 DECEMBER 2013, partner and signatory to wide.

MUMBAI the London Declaration, Eisai Knowledge STALL NO. G28 (HALL NO.1) a global public-private Centre at Visakhapatpartnership that aims to nam, a part of Eisai’s eliminate ten neglected global manufacturing tropical diseases and research network, is (NTDs), including lym- www.idealcures.co.in l info@idealcures.co.in a global supply hub for phatic filariasis, by 2020. increasing access to As part of its commitment to this global medicine at affordable prices. The inteinitiative, Eisai has agreed to supply 2.2 grated manufacturing facility at Visakhabillion DEC tablets to WHO for use in na- patnam, supplies high quality Active tional MDA programmes, free Pharmaceutical Ingredients and Oral of cost.

Solid Dosage products globally, including Lymphatic filariasis, commonly known Japan. The facility has approvals from US as elephantiasis, is a parasitic disease that FDA, MHRA, WHO Geneva, PMDA is transmitted to humans by the bite of a Japan, Korean FDA etc. The research mosquito. Once transmitted, it can cause centre has highly qualified and skilled relymphatic dysfunction and lead to serious search scientists who work on the most manifestations such as lymphoedema, advanced research and analytical equipcausing painful and disfiguring manifes- ment, contributing to the development of tations of the disease. Currently, an esti- the new chemical entities for meeting the mated 120 million people are already af- unmet medical needs. fected and more than 1.4 billion people are The Eisai site in Visakhapatnam was at risk of this disease, globally. High-qual- awarded by International Society for ity DEC (one of the drugs used to treat Pharmaceutical Engineering (ISPE) as lymphatic filariasis) is in short supply Facility of the Year award-2012 in the best worldwide and is not easily accessible to project execution category. Eisai Visakhaat-risk populations in lymphatic filariasis- patnam is the only facility in India to have endemic countries. This poses a major ob- won this prestigious international award stacle for eliminating the disease. from ISPE. Having started the production of DEC EP News Bureau-Mumbai

38 EXPRESS PHARMA November 16-30, 2013

MARKET

PRE EVENT

th 65 IPC to be held at Delhi,NCR Registration extended to Nov 30, Express Pharma is Official Media Partner THE 65TH Indian Pharmaceutical Congress to be held in Delhi NCR from December 20-22, has the theme: â&#x20AC;&#x2DC;Pharma Vision 2020-Empowering Pharmacistâ&#x20AC;&#x2122;'.

The event will focus on bringing pharmaceutical experts across the globe to a single platform where pharmacy education and practices and their development shall be the main issues for debate and deliberation. Empowering pharmacists implies devel-

oping leaders in the sector from diverse backgrounds, who shall provide their invaluable input in the growth of pharma as a profession and an industry.

The last date for registration has been extended to November 30, by when members / delegates planning to attend may register by paying a nominal fee as it was applicable on October 31. Efforts have been made for inviting the President/ Vice

President of India and Health Minister, Government of India, to be the Chief Guests. The venue of the conference is Amity University Campus, Noida. The PHARMAceutical EXPO 2013, concurrent with the 65th IPC, will be organised by FICCI. Around 8,000 plus delegates are expected to attend the plenary sessions, scientific sessions and scientific poster paper presentations. Around 80 speakers

have confirmed participation including 20 foreign speakers.

There is a tremendous response from the students of pharmacy and more than 1,800 papers have been accepted for poster presentation in various scientific sessions viz, pharma technology, medicinal chemistry, pharmacognosy, indigenous drugs, herbal formulations and phytochemistry, pharmacology and toxicology, clinical research

and pharmacovigilance, biopharmaceutics, pharmacokinetics and drug metabolism, pharmaceutical analysis and quality assurance, biotechnology and biotherapeutics, hospital, community and clinical pharmacy, pharma education and professional pharmacy, drug regulatory affairs, pharma management, pharmacoeconomics and pharmacoepidemiology.

EP News Bureau-Mumbai

39 EXPRESS PHARMA November 16-30, 2013

MARKETS DEALTRACKER

M&Aactivity in pharma market witnesses significant decline in value terms in Oct 2013 In terms of volume, the sector recorded 27 venture funded deals

MERGERS AND acquisitions (M&A) activity in the pharmaceutical sector recorded a downturn, valuewise, across the globe. North America witnessed the highest fall in terms of value, recording deals worth about $0.44 billion, a significant decrease of 94 per cent over the previous six month’s average of $6.4 billion.

In one of the key deals announced during the month of October, US-based MedImmune acquired Spirogen, a UK-based biotech company, focused on antibody-drug conjugate technology, for approximately $440 million.

With this acquisition,

MedImmune’s oncology portfolio will be strengthened through Spirogen’s antibodydrug conjugate capability.

In another key deal, Novartis has been granted an exclusive right to acquire Sideris, a US-based biopharmaceutical company, for approximately $300 million.

With this transaction, Novartis will gain access to Sideris’ lead asset, SP-420, which is an orally active small molecule that selectively binds iron and removes it from the body.

M&A activity in the pharma sector decreased in both volume and value terms, when compared to the aver-

M&A (including private equity) trend analysis

Top M&A deals (Oct 2013) Rank

Date

Target

Acquirer

Deal value ($m)

1

10/14/13

Spirogen Ltd. (GB)

MedImmune, LLC (US)

440

2

10/22/13

Sideris Pharmaceuticals, Novartis Pharmaceuticals Corporation (US) Inc. – Asset (US)

300

3

10/28/13

Covidien plc (IE)

Integra LifeSciences Holdings Corporation (US)

265

4

10/03/13

Merus B.V. (ES)

Johnson & Johnson Development Corporation; Novartis Venture Funds; Pfizer Venture Investments; Bay City Capital LLC; Life Science Partners; Aglaia Oncology Fund B.V.

42

5

10/15/13

Vet Therapeutics, Inc. (US)

Aratana Therapeutics, Inc. (US)

38

6

10/04/13

Henan New Century Pharmaceutical (CN)

Tianjin Tasly Pharmaceutical Co., Ltd. (CN)

24.61

7

10/15/13

immatics biotechnologies GmbH (GB)

dievini Hopp BioTech holding GmbH & Co. KG; Wellington Partners Venture Capital GmbH; AT Impf GmbH; Undisclosed Investors

16.28

8

10/04/13

Pharmalink AB (SE)

Industrifonden; Undisclosed Investors; Investinor AS

15.1

9

10/24/13

CytoDyn, Inc. (US)

Undisclosed Investors

14.5

10

10/31/13

Hatchtech Pty., Ltd. (AU) OneVentures Innovation Fund; University of Melbourne; Queensland Biotechnology Fund; Uniseed; Undisclosed Investors; Blue Sky Alternative Investments Limited

11.96

Source: Top venture financing deals (Oct 2013)

Source:

Rank

Date

Target

Investors

Deal value ($m)

1

10/15/13

ADC Therapeutics Sarl (CH)

Auven Therapeutics Management L.L.L.P.; MedImmune, LLC

40

2

10/29/13

Calithera Biosciences, Inc. (US)

Adage Capital Management L.P.; Longwood Fund; Morgenthaler Ventures; Advanced Technology Ventures; Delphi Ventures; Undisclosed Investors

35

3

10/30/13

Immune Design Corp.

(US)

The Column Group; Topspin Partners, LP; Alta Partners; Versant Ventures, Inc.; Osage Partners; ProQuest Investments; SanofiGenzyme BioVentures

32.5

4

10/22/13

Sideris Pharmaceuticals, Inc. (US)

Hatteras Venture Partners; MPM Capital; Osage University Partners; Sunstates Fund

32

5

10/03/13

Loxo Oncology, Inc. (US)

Aisling Capital; OrbiMed Advisors, LLC; Undisclosed Investors

23

Venture financing trend analysis

Source:

40 EXPRESS PHARMA November 16-30, 2013

Source:

MARKETS

age of the previous six months’ (Apr – Sep 2013).

According to Datamonitor's Medtrack database, the pharma sector recorded 27 M&A transactions in October 2013, against the previous six months’ average of 31 transactions. In value terms, the sector recorded deals worth $1.2 billion, against the previous six months’ average of $9.2 billion.

M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of the previous six months’. The sector witnessed no deals in October 2013 The Indian pharma sector witnessed no deals during the month of October 2013.

Venture funding Companies in the pharma sector raised $367.5 million during October 2013, against the previous six months’ average of $228.8 million. In terms of volume, the sector recorded 27 venture funded deals, when compared to the previous six months’ average of 19.8 transactions.

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiol-

41 EXPRESS PHARMA November 16-30, 2013

ogy. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a userfriendly, highly dynamic set of decision support tools and analytics. In-house analysts and

researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment op-

portunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

Definitions 1. Deal value trend is based on transactions where associate

values have been disclosed.

2. Trend analysis excludes rumored and terminated deals.

3. Value and volume analysis excludes private equity exits.

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

MARKET PRE EVENT

Healthcare Brand Summit on Dec 5 Speakers to discuss changing trends, challenges and their outlook on the future of this industry HEALTHCARE BRAND Summit will be held in Mumbai on December 5, 2013. Organised by afaqs! in association with DDB Remedy, a part of the global advertising group, Omnicom, the conference will build on the theme 'Building Brands in Today's Healthcare Marketplace.'

Industry leaders, CEO's and CMO's from Rx, healthcare services, hospitals, diagnostics and devices and industry associations will assemble

on a single platform, to discuss changing trends, challenges and their outlook to the future of this industry. The conference will be open to select 300+ delegates, who will get the benefit of interacting with the strongest line up of speakers in the sector on a marketing platform.

Over 30 speakers from the industry will cover topics including 'The critical value of brands in a changing Indian Healthcare Industry', 'Con-

sumer trends driving healthcare attitudes and behaviours', 'Employing technology to engage multiple stakeholders in changing the healthcare paradigm' and many more. The format of the conference includes panel discussions, speaker presentations and a thought provoking lecture by Nagesh Rao, President and Director, Mudra Institute of Communications.

The Chairperson for the conference is Ranjit Shahani, Vice Chairman and Maging Di-

rector, Novartis India. Some other speakers are Alok Sonig, Senior Vice President & India Business Head (Generics), Dr Reddy’s Labs; Kewal Handa, Chairman, Medybiz Pharma, Lawrence Ganti, Country Head, Merck Serono India, Dr Om Manchanda, CEO, Dr Lal PathLabs, Vineet Singhal,Operating Unit Head - India and South East Asia,Novartis OTC Division, Bhushan Akshikar Senior Manager - CNS, GlaxoSmithKline, Yogesh Kumar Di-

rector, Marketing, Eli Lilly and Company, Devendra Shinde Senior Director, Dr Reddy’s Labs, Ashish Bhatt, General Manager/Country Head - Consumer Healthcare, Merck KGaA, Kunal Bhatia,Director Marketing , Johnson & Johnson, Jitesh Mathur, Senior Director – Patient Care, Clinical Informatics and Ultrasound Philips Healthcare India and many more.

EP News Bureau-Mumbai

POST EVENTS

CII Pharma Summit reflects on regulatory challenges Explores how industry can navigate regulatory challenges and chart strategies for growth AS THE regulatory environment around the world is getting more rigorous, the recently held CII Summit's focus was to explore how the industry can navigate through the regulatory challenges and chart its strategies for growth. Sujay Shetty, Partner-India Pharma Life Sciences Leader, PwC India, gave an overview of the CII-PwC report on 'India Pharma Inc: Changing Landscape of Indian Pharma Industry' released at the event. The CII-PwC report pointed out that there is a slowdown in growth, at 9.8 per cent from 16.6 per cent in 2012, and said the impact is due to many reasons, including lower FDI, and due to new norms on pricing and marketing practices.

Dr Rajiv Modi, Chairman CII

42 EXPRESS PHARMA November 16-30, 2013

Pharma Summit 2013 and CII Gujarat State Council and and Chairman and Managing Director, Cadila Pharmaceuticals said, “India has an efficient pharma industry, which has been making affordable drugs not just for the Indian markets but has also been exporting them to the world. The sector is currently experiencing slow growth.

Henceforth, both the Indian and foreign companies operating in India will have to devise suitable strategies in order to be in the top 10 global markets by 2020.”

Ninad Karpe, Chairman, CII Maharashtra State Council, pointed out that even though India is the third largest market by volume and fourth largest by value, “growth has been good, but only in a particular zone.”

“India is a blessed market

with genetically varied people, which makes it good for clinical trials, but due to public interest litigations (PILs) in court, clinical trials have come down,” said HG Khosia, Commissioner, Food and Drug Administration, Government of Gujarat. He said that when a PIL was filed, the sector should counter it by giving the

correct picture. “We are not against anyone, but we need new drugs to protect human lives,” he added.

JP Parswani, Executive Director, Cadila Pharmaceuticals, said the slowdown provides the sector with an opportunity. “Big data, cloud computing, and networking are changing the way

business is being done in India,” he said, and urged the sector to adapt to the changes.

“The challenge for the pharma sector today is to graduate to the next level, and to get into new areas,” said Dr KV Subramaniam, President and Chief Executive Officer, Reliance Life.

Hasit Joshipura, Senior VicePresident – South Asia, and Managing Director, India, GlaxoSmithKline Pharmaceuticals, said that the new norms will affect growth, but added that with state governments increasing their spending on healthcare, new opportunities were being opened up for the pharma sector. “India remains an underpenetrated market,” he added.

EP News Bureau-Mumbai

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DIAIndia hosts 8 annual conference th

22 sessions were held where 300 participants took part

DIA INDIA presented its 8th Annual Conference in India at the NIMHANS Convention Centre in Bangalore. A conglomeration of researchers, academia and industry professionals representing diverse segments from manufacturing, regulatory, clinical, IT and allied services, the conference reflected DIA’s mission of fostering innovation to improve health and well-being worldwide, and attracted nearly 300 participants addressed by 82 speakers across four tracks, 22 sessions and three plenary sessions.

The theme of the annual meeting was 'The New Clinical Research Environment in India: Implications & Opportunities', considering the current Indian scenario. The meeting was graced by Prof Ranjit Roy Chaudhury (Chairman, Task Force for Research, Apollo Hospitals Group) and Anu Acharya, Chief Executive Officer, mapmygenome.in, who also served as keynote speakers. Dr Shoibal Mukherjee, Vice President, CMO India and Head Asia Medical Sciences Group, Quintiles and Sairamkumar J, Senior Vice President and Global Delivery Head, Cognizant Life Sciences served as the programme chairs.

The guest of honour, M Madan Gopal, Principal Secretary to Government of Karnataka, Health & Family Welfare Department said in his inaugural address, “We are struggling very much in infant and mother mortality and public healthcare issues.

Healthcare will play a significant role in combating it.

We need to focus on basic science research which is the foundation for the healthcare industry.”

Gopal also opined that India is grappling with healthcare affordability, accessibil-

44 EXPRESS PHARMA November 16-30, 2013

ity and quality issues, and culminated his speech by asking participants to come up with discussions and solutions to these issues that specifically relate to clinical research.

Roy Chaudhury, who headed the committee which recommended sweeping changes in India’s clinical trial sector, proposed that, after the government accepts and implements these recommendations, India will soon assume leadership status in clinical trials and garner limelight as the hub of global human studies. From the accreditation of centres conducting human studies to compensation, audiovisual recording of the informed consent, and joint monitoring by state drugs control departments, he sees these reforms as ensuring India’s place as a prime location for clinical trials.

Introducing such transparency will only add strength to the drug regulatory system, reduce bias in the decisions being made, and give all stakeholders a sense of satisfaction that clinical trials carried out in India are fair and that no exploitation of volunteer participants is possible, he ex-

plained.

He further proposed that the Union, state governments and research institutions create a fund to encourage academic and clinical research.

“The Supreme Court needed to ensure that the government did not turn a blind eye to the development in the area of human studies. But, now, our solid recommendations for ethical and scientific human studies conducted in a transparent manner would see In-

dia at the forefront of human studies. Following these recommendations, the clinical research would be strengthened,” said Roy Chaudhury.

In her keynote address, Anu Acharya explored future technological advancements, particularly the fields of nanomedicine, digital medicine, genome-driven approaches to clinical trials and personalised medicine. A few organisations in India have taken beginning steps in these

directions but more must be done in order to remain competitive globally.

In his brief overview of the three-day programme, Dr Shoibal Mukherjee explained that clinical research is important for India because the country has major disease burdens. India must also look beyond its own healthcare models to other countries like Sri Lanka and Nepal, and the Southeast Asia region.

Sairamkumar also en-

MARKET thused that India is passing through an exciting time, and has great potential, in the areas of pharma and clinical research. “We have many problems to overcome but we have to seize the opportunities,” he said.

In her welcome address, DIA Board member and Chair of the DIA Advisory Council of India (ACI), Larisa Nagra Singh requested all delegates to take maximum advantage of the presence of experts who came to this conference from all over the globe. She especially and wholeheartedly welcomed all dignitaries, guest speakers, Dr Jagashetty, Drug Controller of Karnataka State, and keynote speakers, and thanked them for supporting the meeting on behalf of DIA India.

The theme of the annual meeting was ‘The New Clinical Research Environment in India: Implications & Opportunities’, considering the current Indian scenario

The most important part of the meeting was the first collaborative sessions on medical writing and ethics with All India Medical Writing Association (AIMWA) and Forum for Ethics Review Committees in India (FERCI).

Both these sessions were greatly appreciated by delegates.

Dr Nimita Limaye (Vice President, Biometrics & Med-

45 EXPRESS PHARMA November 16-30, 2013

ical Writing, TCS), a member of the DIA India Advisory Council and DIA Community Leadership Council, delivered an insightful presentation on the educational and networking benefits of DIA Communities. He urged participants to join the communities of their

interest. DIA Community information was further shared through the DIA booth in the exhibits, where other companies also showcased their expertise and services for the benefit of the attendees.

Highly interactive sessions delivered a healthy exchange

of information regarding recent developments in new clinical research environments; global development of biosimilars and vaccines; patient awareness, advocacy and informed consent; riskbased approach to monitoring; medical writing, biostatis-

tics, and other topics. A panel discussion was held on media, activism and judicial intervention in clinical research. It involved expert representatives from the industry, media and patient organisations.

EP News Bureau - Mumbai

MARKET

6 Nasal and Pulmonary Drug Delivery symposium held in Mumbai th

Indian Pharmaceutical Association and Aptar Pharma jointly organise the event Usha Sharma Mumbai

CHRONIC OBSTRUCTIVE pulmonary disease (COPD) is one of the most serious health concerns in India.

In a bid to discuss ways and means to handle this disease, Indian Pharmaceutical Association and Aptar Pharma recently organised the sixth symposium on Nasal and Pulmonary Drug Delivery in Mumbai on the theme Global Regulatory Trends.

The conference is a biennial scientific meeting in India to share knowledge about orally inhaled and nasal drug products (OINDPs).

SD Joag, General Secretary, Indian Pharmaceutical Association said, “This is our flagship programme from IPA and it is being held for the sixth year in a row. It is constantly evolving

and becoming more successful. Today, nasal spray is finding fast acceptance in the society, many and many pharma companies are getting into this business. Our aim is to keep the industry updated on all aspects related to regulations and other changes as well as advancements in the business. Through this forum we are educating the industry.”

Dr B Suresh, Vice Chancellor, JSS University commented that drug discovery is a challenging job and today industry-driven drug discovery and developments are also taking place. This in turn is becoming challenging to the regulatory authorities. He also stated that they are finding it difficult to not only set up new regulations but also adhere to it going forward. He said, “Today, the major difficulty faced by the regulators is data incompletion, compa-

nies are not revealing the entire process data to the authority while applying for the patent and unless the complete data is shared with the industry the outcome is not complete.

Hence, I emphasise to the industry that they should share the data in detail because the final result may be the same but process varies from each process.”

Mark Copley, Sales Director, Copley Scientific presents his view, “India has a well established and advanced pharma industry that has considerable experience in the development of inhaled generic products for both domestic and international markets. Currently, India’s rate of development of generic products outstrips much of the rest of the world. Until now focused conferences on inhaled product development have been centered around Europe

and the US where much of the inhaled originator products were developed. However, as India rapidly ascends and begins to tackle highly lucrative and yet highly regulated Western markets it is important that the key Indian stakeholders have access to the latest information and developments in this area.

Therefore a conference such as this (which is now well established as the primary conference for inhaled products in India) should continue to grow in future years.”

Dr Tim Noakes, Medical and Specialty Products Commercial Manager, Mexichem commented, “The symposium brings together a vibrant local pharma industry with international experts representing most of the phases of development and manufacture of inhaled medications. The interactions between the experts of the now substantial local in-

dustry, and visiting experts, is really starting to bear fruit. At the first symposium, ideas and concepts discussed were much simpler, and the gulf between Indian inhaled medication manufacture and some Western manufacturers was all too obvious.”

Copley shares his experience during the event and mentions, “International expert speakers delivered topics that were diverse and of a high quality covering a range of technology around inhaled and nasal products. There was a strong focus on regulatory aspects (European, US, Brazilian and others) especially with regard to generic bioequivalence, which is particularly relevant to emerging markets. The talks were upto-date and covered the very latest thinking; there was considerable debate as a result.” u.sharma@expressindia.com

Alliance India organises conference on pharma regulatory & quality compliance Conference discussed about ongoing regulatory affairs faced by many companies within the pharmaceutical and healthcare sector ALLIANCE INDIA recently organised a conference 'Annual Global Pharma Regulatory & Quality Compliance 2013' in Mumbai. The conference was designed around the

46 EXPRESS PHARMA November 16-30, 2013

ongoing regulatory affairs faced by many companies within the pharmaceutical and healthcare sector; wherein the attendees were primarily from the quality as-

surance/control, regulatory compliance, manufacturing department.

The panel of speakers were Dr Ajaz Hussain, Ex Deputy Director, Office of Pharma-

ceutical Science, US FDA, Mahesh Zagade, FDA Commissioner, Government of Maharashtra, Ranjit Barshikar, QbD and cGMP, Consultant; Dale Adkisson, EVP and

Head, Global Quality, Ranbaxy Laboratories, Aparna Parinam, Associate Director, Regulatory Affairs, Teva Pharmaceuticals, Sanjay Jain, VP, Quality

MARKET Management, Amneal Pharmaceutical, Dr Deepak Haldankar, Vice President, Corporate Quality, Sun Pharmaceutical Industries, Dr PV Kanitkar, Director, Plant Operations, Pfizer, Hemant Narwekar, Head, QA, Cipla, Dr Sanjay Shetgar, Vice President, Operations, Quality Global Generics, Dr Reddy’s Laboratories, Manu Grover, Assistant Product Manager, Waters India, Shaun Quinn: ChromeleonSoftware Product Specialist, Networking and Compliance (Thermo Scientific), Saroj Patnaik, Global Director, Emerson Life Sciences (Emerson Process Management), Venkata Ramana, General Manager, CQA & Head, Com-

A panel-discussion on business and process automation: an integral part of regulatory compliance was lead by significant individuals from the companies present at the conference

puter System Compliance, Ranbaxy Laboratories.

Concerned research analysts/ correspondents were

present to interview the speakers anddelegates. Cipla, Glaxosmithkline Pharmaceuticals, Johnson & Johnson,

Kemwell Biopharma, Perrigo Laboratories India, Piramal Enterprises, Ranbaxy Laboratories, Teva Pharm India, Watson Pharma, Wockhardt and Thomson Reuters took part in the conference.

The conference was consecrated by the directors of Alliance India, Brian Nunes and Faisal Sheikh who accompanied Dr Deepak Haldankar and the chairman of the event Ranjit Barshikar to light the lamp. Barshikar began with his updates on US FDA inspection guidelines. The chief guest, Mahesh Zagade shared his impulsive and well informed notion on the latest indian regulatory requiremnts/ changes.

A panel-discussion on business and process automation: an integral part of regulatory compliance was lead by significant individuals from the companies present at the conference. Adkisson stood out as an empowering speaker post his intense impartation on ways to resolve data integrity issues.

Dr Ajaz Hussain addressed the crowd on data integrity concerns. His humility to have agreed to do so was not only overwhelming, but appreciated by the crowd’s utmost diligence during his presentation. The conference was concluded by Barshikar and Nunes.

EP News Bureau - Mumbai

AZITHROMYCIN

34-year history of partnership with leading pharma companies

active pharmaceutical ingredients & its intermediates*

Commercial scale Antitubercular

Macrolides

Antihypertensive

Antiretroviral

Pyrazinamide# * Isoniazid # *

Azithromycin Clarithromycin Erythromycin base # Erythromycin estolate # Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Sedative, Hypnotic

Antidiabetic

Antifungal

Linagliptin Vildagliptin

Antihistaminic

Flucytosine #

Hypnotic

Antimalarial Artesunate Arteether Artemether # * Dihydroartemisinin Lumefantrine # * Piperaquine

Antiosteoporotic Alendronate sodium Zoledronic acid US DMF

Under Development

*

WHO APIMF

CEP / COS

#

Cetirizine dihydrochloride # Hydroxyzine dihydrochloride Meclizine dihydrochloride+

#

Zopiclone

#

APProVED

Antiepileptic

Eszopiclone

Valproic acid

Antithrombotic

#

Antidepressant

Clopidogrel bisulphate

Venlafaxine hydrochloride

CTD ling under process

*The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility rest with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction. Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India.

Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com

"Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com.

Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

47 EXPRESS PHARMA November 16-30, 2013

EVENT BRIEF NOVEMBER - DECEMBER 21

PHARMAbiotika 2013

PHARMABIOTIKA 2013 Date: November 21-23, 2013 Venue: Hitex Exhibition Centre, Hyderabad Summary: Doctors, nursing homes and hospitals, formulation organisations, API organisations, machinery and packaging, laboratory and analytical equipment, diagnostics, contract manufacturers and clinical research organisations will take part. The event will be colocated with IndiaLabExpo 2013.

Contact details Atanu Bhattacharya Director Human Crayon Management Services C-28, Sector - 4 Noida - 201301, India Tel: (0120) 6528801 / (011) 65378800 Mob: 9810303916 (Delhi) / 9167280126 (Mumbai) Email: atanu@crayon4.com Website: www.pharmabiotika.com

5TH INDIA LAB EXPO Date: November 21-23, 2013 Venue: Hitex Exhibition Centre, Hyderabad Summary: The exhibition will showcase laboratory, analytical, biotechnology, life science, material testing, and laboratory consumable products and instruments.

The expo organisers are expecting more than 50 foreign companies to participate directly and 400+ foreign principals through their channel partners in India. The foreign companies are likely to come from Germany, the US, the UK, Hungary, Switzerland, Italy, Canada, China, South Korea, Russia, Taiwan, Sweden, Netherlands etc.

300+ exhibitors and 10000+ visitors representing

48 EXPRESS PHARMA November 16-30, 2013

21

5th India Lab Expo

diverse industries are expected to participate in the expo.

The focus of the exhibition will be on the latest trends and technologies in the areas of laboratory and analytical instrumentation, chromatography and spectroscopy, biotechnology and life sciences, process control and reactors, medical and clinical diagnostics, clean room and sterilisation, quality control and environmental, educational labs, measurement and testing, liquid handling and filtration, laboratory consumables and allied products, laboratory furniture and construction.

Contact details Karuna Vaid SD (India) Corporation 14 Mall Road, 1st Floor, Hudson Lane, Delhi-110009 Tel: +91-11-43003757 / 08130990660 Email: info@indialabexpo.com Website: www.indialabexpo.com

INNOVATION IN OTC BUSINESS: FROM CONCEPTS TO ACTION Date: November 22, 2013 Venue: The Westin Mumbai Garden City, Goregaon, Mumbai Summary: CubeX, in association with Nicholas Hall & Company is organising a one-day conference, Innovation in OTC Business: From Concepts to Action. Nicholas Hall will give expert views on innovation as a significant growth driver for OTC industry. Also, network with other expert speakers who have developed

22

Innovation in OTC Business: From Concepts to Action

innovative strategies, spanning across various aspects such as business models, products, processes, marketing and channel management, into real-life action.

Marol, Andheri (East) Mumbai - 400 059 Tel: (022) 61727162 Fax: (022) 61727273 Email: chaitali.patil@ubm.com

Contact details CubeX (A Division of Sorento Healthcare Communications) Unit No. 12, Garodia Estate 3/A Udyog Nagar, S. V. Road Goregaon (West) Mumbai - 400 064 Maharashtra Tel: (022)4036 2008 Email: rshriyan@cubex.co.in

HEALTHCARE BRAND SUMMIT

CPHI INDIA Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai Summary: Reflecting the continued growth in the API, generics, fine chemicals and bio-pharmaceuticals industries on the Indian sub-continent, CPhI India and related pharma services events saw an increase in visitors and exhibitors.

CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals. Take this opportunity to showcase your products and services while enhancing your brand at South Asia's leading pharma industry event.

Contact details Chaitali Patil UBM India Times Square Unit No 1 & 2, ‘B’Wing, 5th Floor Andheri Kurla Road

Date: December 5-6, 2013 Venue: Hilton Mumbai Summary: afaqs! is organising the Healthcare Brand Summit, that will bring together some of the most respected industry leaders, CEO’s and CMO’s from Rx, OTC, healthcare services, hospitals, diagnostics and device, wellness companies on a single platform, where they will discuss challenges and share their experiences. Joining them will be healthcare communication experts from branding, social media, analytics, technology solution providers who will share their learning and experience in building brands in healthCare.

Contact details Samarjit Singh Vice President- Sales & Marketing B3, 1st Floor, Sector 4, Noida - 201301 Ph: +91-120-4077800 Mob: +91-9811436040 email: samarjit.singh@afaqs.com Web: www.afaqs.com

65TH IPC, 2013 Date: December 20-22, 2013 Venue: Amity University, Noida Summary: Indian Pharmacy Graduates’ Association will host 65th IPC, 2013. Express Pharma has been chosen as the "Exclusive Official Media Partner" for the 65th IPC, 2013. The event will be organised by Indian Pharmaceutical Congress Associa-

03

CPhI INDIA

tion. The academic partner for the event is Amity University, Noida.

Contact details Dr Arun Garg General Secretary IPGA Director PDM College of Pharmacy Bahadurgarh, Haryana Mob: 09416056213

11TH EDITION OF BIOASIA Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre Summary: The 11th edition of BioAsia is dedicated to the theme – ‘Innovate. Evolve’.

BioAsia’s focus on ‘Innovation in lifesciences’ will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions.

Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years.

In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA).

Contact details Paridhi Gupta Tel: 040 66446477

“What drives me? My

goal to satisfy demanding customers. Worldwide.”

Basem Gerges Bachelor of Science Electronics Engineer (Sales Manager)

We from Optima Pharma are convinced: A demanding customer should never have to settle for mediocre solutions and - above all - not when it comes to safety and hygiene. This is why we plan, develop and design filling lines that keep all the options open – regardless where your machine will produce.

P-mec India | December 3 – 5 | Mumbai | India | Hall 5 | Booth # E 28

Member of

OPTIMA pharma GmbH | 74523 Schwaebisch Hall | Germany | www.optima-pharma.com OPTIMA India packaging machines Pvt. Ltd. | Bangalore | India | www.optima-ind.com

cover )

CPHI SPECIAL

API INDUSTRY CROSSROADS at

The Indian API industry has been an unprecedented growth story till now, but the road ahead needs to be charted with considerable strategy and thought if India needs to establish itself as a foremost player. The stakes are high. Shalini Gupta asks industry experts what it would take to turn the tide in our favour

50 EXPRESS PHARMA November 16-30, 2013

(

THE MAIN FOCUS

Pg 52./ NEERAJ VASHISHT Dominance in APIs: Within grasp,but no room for complacency Pg 54./ VINEETSINGHAL There is a window of opportunity for Indian API industry to regain lost space Pg 56./ CATHERINE TANG API manufacturers need to relook business processes to operate more efficiently Pg 58./ GIRISH MALHOTRA Indian API producers have to consider an alternate ‘process centric’model Pg 59./ JAMIE DAVIES Frontier markets offer major opportunities for API manufacturers Pg 60./ GURPREETSANDHU The patent expiry factor is slated to drive the API market for the coming years Pg 62./ ADEFEMI ADENUGA Appropriate policies and increased focus on quality could make India the leading producer of APIs

51 EXPRESS PHARMA November 16-30, 2013

cover ) NEERAJ VASHISHT, Senior Principal, LifeSciences Practice, IMS Consulting Group

Dominance in APIs: Within grasp, but no room for complacency

I

ndian API industry is one of the greatest success stories never fully recounted. It ballooned from a small and irrelevant niche aspirant to a sizeable player with significant potential to achieve global dominance, all within a few years!

growth; but we need to scale this success to the next level.

Consider this: 1. Indiaâ&#x20AC;&#x2122;s supply to the US API market increased at a rate of 44 per cent over 2008-2012. It is now the second largest supplier to the US. Looking back, in 1999, India had only a handful of Abbreviated New Drug Applications approved by the US FDA 2.India accounts for nearly one-fifth of the API supply to western Europe 3.While China Special is one of the largest API players in the world, India has double the number of established manufacturers accredited to supply to regulated markets.

Globally, generic APIs will outpace innovator APIs; with Asia Pacific set to outpace established western markets. However, growth rate of APIs have slowed down from the heady days. Within this milieu, India is in a very unique position.

Our success in the regulated markets sets us well for long-term

CPhI

INDIA

52 EXPRESS PHARMA November 16-30, 2013

Here are the three things the Indian industry should consider doing: Strengthen the core: FDA warnings have gone up significantly over the past four years. With multifold growth in volumes, it should not be entirely unexpected. However, with stiff and growing competition, any slippages can cost us dearly especially since we rely heavily on exports to the US market. Upon a deeper analysis, most of the issues with Indian companies are not with the quality of the products per se but on the transparency of practices, strength of processes and adherence to controls (which is what cGMP focuses on). Addressing these issues will be vital to support the growing scale of the industry.

Build newer markets: Many markets, some right in our backyard are beginning to show significant growth potential. These include countries in the Asia Pacific, Commonwealth of States (CIS), the

( Middle East etc. that are likely to show double digit growth. With our geographic proximity and proven capabilities, Indian API players are poised for interesting growth options in these markets. Besides, this will help diversify our geographic portfolio and reduce risks especially as western markets continue to face significant downward cost pressures.

Expand into newer areas: Last decadeâ&#x20AC;&#x2122;s experience in manufacturing APIs for

Indian API industry is at an important cross road.

While it has enjoyed significant success over the past decade, the ground it stands on is continuously shifting

small molecules has helped companies understand how sophisticated customers buy.

Indian companies must now significantly ramp up their efforts to scale up the value chain using value added offerings, (contract research and manufacturing, novel drug delivery systems, new chemical entities related offerings etc.) and venturing into newer spaces like biosimilars etc to catch the next wave of opportunity.

53 EXPRESS PHARMA November 16-30, 2013

This has been taking place in pockets but a lot more needs to be accomplished.

In summary, the Indian API industry is at an important cross road. While it has

enjoyed significant success over the past decade, the ground it stands on is continuously shifting. On one hand, the industry must continue to strengthen its core by

THE MAIN FOCUS

investing in quality and processes and on the other take calculated risks to maximise its global growth opportunity. Indian API players have shown remarkable

resilience and entrepreneurship in achieving outstanding results. This must boldly continue to take India to its next phase of evolution in the API space.

cover ) VINEET SINGHAL, Business Unit Director, Asia Pacific Middle East & Africa Region, DSM Sinochem Pharmaceuticals

There is a window of opportunity for Indian API industry to regain lost space

I

ndia has been the forerunner in the global API industry for more than three decades now with significant focus on process innovation, skilled manpower, costs and market access. The industry has also largely been built on the strong skills of Indian industry in chemical synthesis. With these unique blend of skills and competitive advantages, India has led the global API industry driving the shift of API manufacturing from Europe to India. However, in the past decade, there was a significant shift in the challenges faced by the API industry and the key drivers of the industry. The key determinants started with scale, strong backward integration into intermediates, lower operational costs, lower cost of capital and Special governmental support in terms of subsidies etc.

CPhI

INDIA

Lessons from China The focus of the Chinese government to drive innovation and scale leading growth and support to pharma as a key area, in turn was responsible for the Chinese API industry with large scale, low cost and better infrastructure such as power, transportation etc. China has also built large capabilities in intermediate space thus giving us a competitive advantage and has gained significantly in the global API market with lower cost and scale as the key drivers.

54 EXPRESS PHARMA November 16-30, 2013

The Chinese success story has led to closure of a number of API units operating out of India, in the past two to five years. While India still holds a place in the global API industry when it comes to niche APIs, competition across the silk route is expected to catch up on the technology intensive niche APIs as well. The industry is at a cross roads now. The single minded focus on global leadership in APIs primarily driven by low cost and huge scale of Chinese players has had its side-effects in terms of significant and irreparable ecological damage, instances of gaps in quality, companies not being sustainable financially since they spread too thin due to irrational addition of capacities and reducing governmental support to the industry there in terms of tax rebates etc.

Winds of change New drivers of change now are emerging to be global focus on green / eco-friendly processes, reliability in terms of supplies particularly in a sensitive field such as APIs, sustainability in terms of financial viability to further ensure continuity of supplies of key life-saving medicines, and most importantly the renewed focus on quality.

( There has also been considerable erosion of cost advantages of the Chinese industry such as lower power cost. The strengthening of Yuan and weakening of Rupee also makes the Indian industry competitive. This throws up a window of opportunity for API industry from India to regain lost space.

With the shake out, which we have witnessed in the API industry from India, financially sound companies who are fundamentally secure and assured of reliability and sustainability to global customers can lead the resurgence of API industry from India. Industry from India needs to further strengthen its core competitive advantages of

THE MAIN FOCUS

India has led the global API industry driving the shift of API manufacturing from Europe to India.

However, in the past decade, there was a significant shift in the challenges faced by the API industry and the key drivers of the industry skilled manpower and technological competencies. The wide market access that API players from India have had can further be strengthened. Companies leading the industry in terms of green technologies like enzymatic processes, which lead to

lesser carbon foot print and reduce electricity and water consumption, will be increasingly be viewed favourably.

Infrastructural support from the government in terms of power, transportation and governmental clearances for

projects/lesser restrictive environment, will help the industry to regain lost space. API industry from India also needs to focus on building capabilities in intermediate space, since the strength of backward integration will give make the industry

cost competitive as well as ensure control on quality and reliable supplies. Support from the government in developing intermediate industry in India will be helpful. Since, the API industry is also fairly resilient in face of economic swings, it will also help the Indian exchequer in terms of export earnings by supporting the Industry with certain incentives.

While, it looks possible to turn the table, itâ&#x20AC;&#x2122;s also clear that a lot needs to be done by the Industry and the government to build the global image of API industry from India on the key planks of skill, quality, reliability, sustainability, eco-friendly processes and innovation.

55 EXPRESS PHARMA November 16-30, 2013

cover ) CATHERINE TANG, Director Biomedical, Spire Research and Consulting

API manufacturers need to relook business processes to operate more efficiently

D

espite the uncertain global economic climate, the growth momentum for generic drug spending will continue. Its share of total drug spending is set to increase. Demand growth, primarily from emerging markets, is being accelerated by healthcare reforms in the major developed markets of the US and Europe; as well as impending patent cliffs, where some $75 billion worth of drugs go off patent between 2012 and 2015.

This presents new potential for manufacturers of API and drug intermediates (active pharmaceutical ingredients and excipient components used in generic formulations) in India.

India is wellSpecial poised in the global API industry, but headwinds from higher export barriers and increased pharmaco-vigilance are major threats that will inevitably raise production costs and erode margins. To retain its pole position in the competitive generic market and claim blue sky space, API manufacturers need to re-look the business processes to operate more efficiently. And to keep Indian drugs on the worldstage amidst rising defaults on quality, India-based API manufacturers should invest in branding to make made-in-India drugs more

CPhI

INDIA

56 EXPRESS PHARMA November 16-30, 2013

acceptable globally.

Assurance of quality has to be the uppermost priority, given the new requirements from Europe.

Indian drug manufacturers will need a quality assurance and branding strategy to complement its current low-cost value proposition. In light of increased FDA inspections, companies might adopt technology to automate process data collection such that the complex manufacturing processes can be better managed. Investing in information management systems will help to optimise workflow, derive better quality metrics and ensure adequacy of audit trails.

The current physical infrastructure for inbound logistics has a direct impact on competitiveness.

In this regard, India is out-competed by other global drug production hubs like Singapore, Ireland and Puerto Rico. The government has a role to play here in nurturing the industrial infrastructure for API production, taking a leaf from what Singapore has done with its Tuas biomedical park. API manufacturers should also consider backward integration to reduce reliance on

( the import of raw materials from China and other countries. Product registration fees and other forms of levies applicable to Indian API exporters warrant concrete mitigation strategies in order for India to remain competitive on the world stage.

As the third largest exporter of generic drugs, Indian drug makers and pharmalabs continue to receive strategic support from the government and

especially information management systems.

Lastly, Indian exporters should reach out to emerging markets with messages not only on cost-effective medi-

cines but also value co-creating initiatives that encourage collaborative strategies with destination countries and companies.The growth of Indian companies in the

India is wellpoised in the global API industry, but headwinds from higher export barriers and increased pharmacovigilance are major threats that will inevitably raise production costs and erode margins.

Assurance of quality has to be the uppermost priority industry councils. But new challenges on the blue-sky horizon call for the financial assistance provided by the government to expand so as to support upstream investment in process automation

pharma industry is handicapped by differential laws and regulation within India itself. The industry would benefit from a consolidation of the API manufacturers so

that benefits of scale can be reaped. Lastly, more efforts are needed to raise the global customer confidence level associated with made-inIndia drugs.

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November 16-30, 2013

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cover ) GIRISH MALHOTRA, President, EPCOT International

Indian API producers have to consider an alternate â&#x20AC;&#x2DC;process centricâ&#x20AC;&#x2122; model

I

n the API producer world, catapulting from fourth position to number one, could be considered a miracle, especially for a country that has stepped on the global playing field about eight years ago. However, such a move is not out of the realm of reality. A concerted effort on multiple fronts would be needed. If Indian companies do not adopt the outlined road map, any other country can adopt this road map and change their relative standing. We have to recognise that such a move is filled with challenges that will have pain but considerable elation as well, which in the long run, would overcome the short-term pain.

Some of the major players have been around for more than 25 years but due to profits and opportunities others have joined the fray. Most of the companies in India have followed the model that big pharma companies have used.

Majority of the API Special are fine/specialty chemical that have disease curing value. Since the chemistries are similar they can be executed at any fine/specialty chemical company having the necessary equipment. This allows an easy entry for many chemical companies to become API producers. Companies have used their existing equipment to produce different APIs and although this is a profit making model, it has many shortcomings.

There is major difference between chemicals that are used to

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58 EXPRESS PHARMA November 16-30, 2013

improve life style vs. the chemicals that are used to cure diseases. Purity and quality consistency are the utmost requirement for APIs. To ensure the same, quality regulatory bodies have set certain methodologies every company has to follow.

Fractional milligrams to few hundred milligrams of the API needed for different diseases requires variable amount of API to serve the need.

With many companies producing the same API their processes are inefficient and unsustainable. Economies of scale to have the most optimum process do not exist. API producers are not worried about these as the related costs are passed on the customers.

Indian API producers like others adopted the same model. This model puts emphasis on meeting regulations i.e. they have become 'regulation centric'. Regulatory compliance is a must and this is where the opportunities lie. For the Indian API producers to become number one, they have to consider an alternate 'process centric' model that improves profits, facilitates and even exceeds regulatory compliance.

Process centricity results in the most economic process (3) and allows total command of the process. Many of the

Continued on Pg 61

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JAMIE DAVIES, Head of Pharmaceuticals, Medical Devices & Healthcare, Business Monitor International

Frontier markets offer major opportunities for API manufacturers

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P h I Worldwide 2013 highlighted several key trends impacting the global API industry, specifically currency fluctuations, frontier markets, biosimilars and, perhaps most importantly, ensuring quality manufactur-

ing. Currency fluctuaingly entering non-traditions are generally tional markets. These underappreciated by countries often have multinational API volatile currencies, Special companies and their which can dramatically investors. These firms affect the level of repatrihistorically focused on few ated revenue from year-tocountries, mainly developed year and quarter-to-quarter. states, and domestic revenue The dramatic weakening of the accounted for a higher propor- rupee in mid-2013 has signifition of their overall sales. Due cantly affected Indian API to the rise of emerging mar- firms. Imports of raw materials kets, drugmakers are increas- are more costly, while revenue

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earned abroad is higher.

Frontier markets offer major opportunities for API manufacturers. Sales will be low initially and losses are possible for several years.

However, those firms that aggressively penetrate frontier markets before competitors and maintain market share will see significant returns over the long term. Indian companies have expanded significantly in

frontier markets, but competition is increasing.

API firms based in emerging markets will increasingly produce hard-to-manufacture pharmaceuticals. Firms in developing countries enjoy low operating costs, but have traditionally lacked the expertise and equipment to

Continued on Pg 61

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59 EXPRESS PHARMA November 16-30, 2013

cover ) GURPREET SANDHU, Managing Director, Reva Pharmchem

The patent expiry factor is slated to drive the API market for the coming years

A

PIs forms the most vital part of every formulated end product, and of the whole pharma industry. The overall API market was valued at $101.08 billion in 2010, and is expected to grow at a CAGR of 7.9 per cent from 2011 to 2016. The development in the High Potency Active Pharmaceutical Ingredient (HPAPI) and Biogeneric drugs is boosting the growth of the Active Pharmaceutical Ingredient (API) market in India.

There has been a paradigm shift in the use of innovative drugs to that of low-cost API drugs after the Special economic recession, thereby causing a positive impact on the overall growth of the API market in India and China.

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growth as market dynamics have undergone a major change with the expiration of patents pertaining to global blockbuster drugs in the US. The consequences of the economic crisis has hit the innovative drugs market hard, with less budgets allocated by the major players for the R&D of innovative drugs. This has led to drying up of pipelines for new drugs, and therefore the market for generic drugs is quickly growing.

Thus, the patent expiry factor is slated to drive the API market for the coming years.

Patent expiry and the API boom

Asia-Pacific excluding Japan growing fast

In order to keep abreast with this change, API manufacturers are applying various novel technologies to reduce the processing time in order to yield more production. There has been an increase in influence of API players from India after the economic recession. The recession restricted the growth of innovative sector in developed economies such as the US and Europe, as the innovative sector requires huge investments. This has helped fuel the growth of generics market in Asian countries such as India and China. The API market is facing a period of unprecedented

European countries such as the UK, France and Germany are promoting the use of generics by providing incentives to the doctors for writing prescriptions relating to generic drugs and also to the pharmacists if they offer the generic equivalent of prescribed drugs. Thus, generic API market is expected to grow till 2016 as compared to the innovative API Market. On a geographic basis, the highest growth rate for APIs between 2008 and 2012 was in Asia-Pacific (excluding Japan), which experienced average annual growth rate of 13.9 per cent followed by the Middle East with

60 EXPRESS PHARMA November 16-30, 2013

( 8.7 per cent average annual growth, and Eastern Europe and the Commonwealth of States (CIS) with 8.2 per cent average annual growth, according to the CPA report.

The developed markets in Western Europe, North America, and Japan had slower annual growth rate.

Western Europe’s API market had the lowest annual average growth rate, 2.5 per cent followed by Japan at 3.4 per cent and North America at 3.8 per cent.

On an absolute basis, however, North America is still the largest API market (including both captive and merchant markets) followed by Asia Pacific although Asia Pacific is gaining ground. The North America share of the global API market declined three percentage points between 2008 and 2012 as the share of Asia Pacific increased. North America’s share was 43 per cent in 2012, down from 46 per cent in 2008. Asia Pacific’s share was 28.3 per cent in 2012, up from 24.2 per cent in 2008, according to the market report. The US remains the largest global market on a country basis, accounting for 39.7 per cent of the global API market in 2012.

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Continued from Pg 58

Continued from Pg 59

Indian API...

Frontier markets...

current challenges should be considerably reduced or eliminated. Economies of scale significantly lower the total business costs i.e. improve profits, regulatory compliance would be facilitated and/or exceeded.

Environmental compliance costs are also lowered. Total business process is improved.

Like any other competitive race, companies will have to pick the API/s for which they have the best process and essentially drive their competitors out. This is the down side. Best of the technologies will create world scale plants. Process excellence will exceed regulatory requirements. This strategy implemented across the API spectrum could make India the number one API producer.

make advanced therapeutics such as biosimilars. As economies in these non-traditional markets grow, capital will be released for the establishment of modern production facilities, with output destined for both domestic consumption and export. Indian companies need to invest further to compete in the biosimilar sector.

Ensuring quality manufacturing standards is one of the fundamental responsibilities of API companies.

Although costs will rise, we believe it is necessary for firms, agencies and payers to work collectively and increase dialogue to ensure compliance to Good Manufacturing Practice (GMP) within the increasingly globalised pharma market. There needs to be a cohesive top-down and bottom-up approach to guarantee public safety and trust in the industry. Indian firms are under intense scrutiny to improve standards and regain reputation.

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61 EXPRESS PHARMA November 16-30, 2013

cover ) ADEFEMI ADENUGA, Industry Dynamics Senior Analyst, GlobalData

Appropriate policies could make India the leading producer of APIs

A

c t i v e Pharmaceutical Ingredients (APIs) are a crucial component of drugs regardless of governments’ austerity measures to counter soaring healthcare expenditures. Consequently, API manufacturers, particularly in India – a low-cost market, are poised to continue to reap significant benefits.

Currently, the Indian pharma market is ranked third globally in terms of volume and 13th in value terms, accounting for about 10 percent of the world's production by volume and 1.5 per cent by value. Despite the lower ranking in terms of value, a result of the significantly low prices of medicines in the country, the market is one of the fastest growing in the w o r l d .

Furthermore, it ranks fourth in Special terms of production and 17th in terms of export value of bulk products and dosage forms. Although India’s strides to establish itself as a dominant force in the global pharmaceuticals marketplace are noteworthy, certain issues require urgent attention before it can stake its claim as being the global leader in API manufacturing.

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Pertinent quality issues According to India’s Department of Pharmaceuticals, the country currently has over 100 FDA-compliant

62 EXPRESS PHARMA November 16-30, 2013

pharmaceutical manufacturing plants outside the US, the largest number in the world. Furthermore, it has about 793 WHO-GMP-approved pharmaceutical plants and over 153 European Directorate of Quality Medicines (EDQM)-approved plants with cutting-edge technology. Clearly, these statistics aid API manufacturing in India. However, quality problems, which have led to product recalls and import bans being imposed on Indiabased drug makers such as Ranbaxy and Wockhardt, are a cause for concern in a global industry where trust and quality are crucial. Between 2010 and 2011, exports accounted for about 44 per cent ($8.9 billion) of turnover in the Indian pharma industry. However, this is being threatened by quality problems.

Uncertainty surrounding policies The proposed ban on Foreign Direct Investment (FDI) by the Indian parliamentary panel has added to the air of uncertainty, which already includes intellectual property (IP) protection and significant price cuts.

While a ban on FDI on brownfield

( (existing) pharma projects in the country would possibly increase domestic participation and keep drug prices low, it could also backfire by weakening local drug makers’ ability to build capabilities. Instead, the Indian government should focus on ‘clustering’, a strategy that encourages FDIs by multinational companies and also fosters rapid technological and infrastructural development – potential gains for India’s API manufacturers.

Despite the lower ranking in terms of value, a result of the significantly low prices of medicines in the country, the market is one of the fastest growing in the world. It ranks fourth in terms of production and 17th in terms of export value of bulk products and dosage forms

The way forward The FDA’s aim to increase its inspection of foreign-based drug manufacturing facilities, a decision aided by new fees

63 EXPRESS PHARMA November 16-30, 2013

levied by the regulatory body on companies with manufacturing facilities outside the US, bodes well for API manufacturers in India. Although margins will possibly be decreased, it

should force them to step-up their focus on quality. Indiabased API manufacturers already have significant technical skills and scale for global success. In addition, there is a

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growing demand for APIs, be they for branded or generic drugs, worldwide. With the appropriate policies and schemes, such as the government’s recent establishment of

national centers for R&D in phytopharmaceuticals and API at Hyderabad, and increased focus on quality, there is no reason why India cannot be the leading producer of APIs.

cover ) I N T E R V I E W

We plan to increase our production capacity by starting a new plant The United Engineering Company is a leading pharmaceutical packaging player in the country. For the last five decades, it has made its presence felt in this sector. Express Pharma spoke to Debasish Roy, Managing Director and Subhasish Roy, Chief Executive Officer, The United Engineering Company to know more about the company and its future plans

First of all, we convey our greetings for completing five decades in this industry.

Today, after so many years, how do you look back to the achievements of the company.

See, United Engineering Company (UEC), which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care.

With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work. It has tried to build relationships rather than clients or customers. We have never compromised with Special the quality in all aspects of the business, be it machines, service or relations.

Today, the list of clients, which include the who’s who of the Indian pharma industry are on our client list and speaks volume of our achievements.

Besides, the hard work and efforts of the members, the company does play a very crucial role in making ‘The United Engineering Company’, what it is today.

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Which are the major pharma machines manufactured by the company?

We specialise in machinery

64 EXPRESS PHARMA November 16-30, 2013

DEBASISH ROY for packaging ampoules, vials and bottles. We provide a complete solution for the whole production line. UEC has also mastered in providing machines for automatic tablet coating. Our product ranges from semi-automatic (R&D models) to fully automatic machines.

‘UNITED’ machines are versatile in nature and thus can accommodate containers of different shapes and sizes. UEC also provides customised solutions to its customers.

UEC has always been keen on introducing latest designed machines to the industry.

What are the latest products from your basket and what more can we expect in the coming days?

Our latest development is the UNITED ‘EAC’, Automatic External Cleaning & Drying Machine for ampoules and vials. This machine plays a very big role in improving the productivity of an automatic

SUBHASISH ROY inspection and labeling machine in the production line.

We have also developed High Speed Sticker Labelling Machines for Ampoules and Vials, with special unique features incorporated in it.

Currently, we are working on the development of a High Speed Ampoule Filling and Sealing Machine, which would operate in rotary motion with special liquid dosing capabilities and other unique features. It would be in fact, the first of its kind in the country and the most compact machine for high output productivity. We plan to develop machines for packaging pre-filled syringes and automatic cartoning machines for containers of various sizes in the near future.

Adhering to strict ‘Quality Control’ parameters, is an important element in today's pharmaproduction

business. Can you elaborate on this?

From a nut to the main component of the machine, we provide the best quality material complying with the highest standards of manufacturing guidelines. We perform regular quality checking programme for each and every machine before being despatched.

Hence, Quality Control does form a crucial part of our validation programme.

How are you currently placed in the Indian and the international market?

In India, we are considered to be one of the best and trusted brands in the industry.

'UNITED' machines also cut a niche for itself in the international markets.

Keeping pace with the latest 'technology upgrades' is one of the key attributes for attaining success in today's fast changing world. How is UEC taking care of this aspect?

In the last few years, this field has seen a favourable metamorphosis in technology.

Automation of machines has improved to a new dimension which adds a lot to the productivity of the machines. This also helps the user to get a clear view on the overall performance and utility of the machines.

UNITED machines are equipped with the latest technological trends.

We at UEC, are always keen on upgrading our existing machines in paralance to the new developments. We believe that tomorrow’s technology should be standard in every UNITED machine produced today.

Today, Indian pharma machines are being exported to different parts of the globe.

Which countries do you export?

We have a strong foothold in the overseas market. We export mostly to South African and Asian countries. Yet, we have supplied a few machines to the US and Canada as well.

Presently, we are looking forward to extend our horizons to the European and other markets.

Can you please elaborate on your future plans?

We are planning to increase our production capacity by starting a new plant, incorporating modern equipment and state-of-the-art facilities.

We have traversed five decades in this business, but for UEC entering the 51st year is the beginning of a new chapter.

In the words of Robert Frost: ‘We have miles to go before we sleep.’ We plan to venture into new areas, work harder and excel in what we do.

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Serving the pharma industry for last five decades KOLKATA-BASED The United Engineering Company (UEC) with the brand name ‘United’ is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care. With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing automatic tablet coating solutions. UEC also provides customised solutions for its customers.

UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has expanded its footprints abroad in a large way.

‘United’ machines Special are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, UAE, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘United’ machines provide technically advanced solution for its customers.

Presently, UEC is having its head office in Kolkata. It has

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65 EXPRESS PHARMA November 16-30, 2013

three manufacturing units in West Bengal, covering an area

of over 10000 sq ft. UEC is having another office in Mum-

bai along with a service station. UEC has been honoured

by the prestigious ‘Innovator’s Continued on Pg 69

cover ) Neomachine Mfg Co: Aleader in automatic coating technology KOLKATA-BASED Neomachine Mfg Co was started in 1973 with an objective of manufacturing all types of pharmaceutical machinery.

Special For a decade, the company catered to the requirements of the Indian domestic players by

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66 EXPRESS PHARMA November 16-30, 2013

manufacturing pharma machinery like bottle filling and washing machine, tray driers, mechanical sifter, vial filling machine, coating pan, fluid bed drier, pressure vessel, planetary mixer etc.

While catering to this market segment, Neomachine chanced to come across a Kolkata-based pharma pro-

ducer, who were facing problems in film coating of tablets.

Until then, the tablets were being coated in conventional pans, which were not only causing health hazards to the coating personnel, but was also a time consuming process. Inspired by this opportunity, Neomachine started the process of developing an automatic coat-

ing machine in the right earnest. After, two years of research and development, the first â&#x20AC;&#x2DC;Neocota Automatic Coating Systemâ&#x20AC;&#x2122; was manufactured in 1984.

During the last three decades, Neomachine manufactured and marketed over 500 machines, out of which 50 machines were exported to the

ANUP MAITRA, Managing Director, NEOMACHINE

US, Australia, China, Jordan, Yemen, UAE, Uganda, Kenya,

Continued on Pg 69

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REPORT

CPhI Worldwide and CPhI Pharma Evolution’s second annual report released Indicates that over the next few years, big pharma’s business model is shifting from its traditional markets and moving towards the development of niche medicines CPHI WORLDWIDE and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, released the second edition of its annual report with its expert industry panel identifying the market trends set to affect growth and innovation across the industry.

The first four articles for the report indicate Special that over the next few years, big pharma’s business model is shifting from its traditional markets and moving towards the development of niche medicines, companion diagnostics, and perhaps most significantly, towards increased partnerships, both with CMOs and academia. The implication of this is that innovations and IP processes will be coming from outsourced partners, big pharma and academia. QbD is seen as being essential to the process of harmonising product and process development, which will accelerate standards, enabling more

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REPORT’S EXPERT HIGHLIGHTS Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers ■ Big pharma to develop niche medicines and associated companion diagnostics ■ Technical advances in design and development to reduce costs- with a more collaborative model between partners and increased outsourcing in development processes ■ Academic partnerships with pharma and CMOs to increase innovation William Botha, Sensei, Interlean ■ Increased outsourcing to lower risk processes such as packaging and logistics ■ Increased vertical integration when risks are higher (e.g. APIs) ■ Changing pharma business model towards niche products or commodity-based low margin products ■ Regulators to pay increased attention to human factors and staff turnover Bikash Chatterjee, President and CTO, Pharmatech Associates ■ Pharma to focus on improving drug discovery and development effectiveness ■ CMOs need to develop larger service development offerings ■ Understanding of foreign regulatory requirements, beyond FDA, to become increasingly common ■ FDAs enforcement of QbR in generics to reduce GMP transgressions

■ ■ ■ ■

Ajaz Hussain, Independent Consultant ■ Continuous manufacturing processes to continue to grow, encouraged by the FDA ■ CDER manufacturing metrics to help regulators identify data that is too good to be true and potential compliance issues ■ Industry to witness more frequent inspections of foreign facilities Girish Malhotra, President, EPCOT International ■ Pharma to switch to low-cost drugs that have a larger customer base ■ Industry is at risk from possible drug shortages as weaker players in developing countries fail to meet regulatory requirements ■ Minimizing process inefficiencies through PAT and QbD will lead to 2025% savings of global revenues ■ Continuous processing is forecast to revolutionise manufacturing with reduced costs, increased sustainability and consistently higher product quality ■ Alternatives for APIs include modular technologies in place of continuous processing Prabir Basu, Independent Consultant and a former Director of NIPTE ■ Regulatory environment needs to change to offer incentives for achieving excellence- presently pharma is focussed on non-

compliance FDA should focus resources on regions with a likelihood of failure FDA could learn from ‘trust and verify’-style OHSA Voluntary Protection Program Biggest threat to industry is that most companies get ingredients that are not being inspected cGMP needs to be extending to excipient manufacture.

Emil Ciurczak, Principal at Doramax Consulting ■ Speed of development from lab scale to small scale manufacturing is dramatically accelerating ■ Batch processing may now be a thing of the past ■ In 10-15 years it will be impossible to tell if one is in a generics or branded pharmaceutical facility ■ Generics race will lead to smaller number of larger generics companies ■ Increased collaboration between FDA and EMA, with QbR adoption ensuring generics manufacturers improve process knowledge-base Hedley Rees, Principal at PharmaFlow ■ Regulation with such a prescriptive approach is not actively targeting mal-intent within the supply chain ■ Regulators should raise the bar for CMC filing at the IND/CTA stage to ensure only the most promising molecules enter the clinic ■ Improvements in in silico and in vitro testing will help to improve predictive capabilities ■ Track and trace under FDASIA to support supply chain improvements but a change in behaviour is needed to truly ensure safety ■ Contract research and manufacturing sector needs to take an active role in innovation and share some of the costs and risks

67 EXPRESS PHARMA November 16-30, 2013

cover ) developed partnerships and strategic uses of outsourcing.

Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers forecasts in his submission that big pharma will move towards the development of niche medicines, alongside companion diagnostics for patients with specific genotypes.

Echoing these sentiments, William Botha, Sensei at Interlean, says that as well as a move towards niche medicines, pharma will increasingly diversify towards commodity-based, low margin products- meaning we will see an increased specialisation, particularly amongst small and medium pharma. To achieve this goal, he argues that there will need to be increased connection between product development and manufacturing so that products can move more seamlessly through the development process.

Bikash Chatterjee, President and CTO, Pharmatech Associates, argues that two essential developments that will be universally adopted over the next five years are the concepts of Quality by Design (QbD) and Question-based-Review (QbR).

If we are to move towards the harmonisation of product and process development cycles, QbD will be essential not only in safeguarding quality Special but also in reducing the cost of development. However, one area that is forecast for particular change is the application of QbR within the generics drugs industry. For instance, FDA enforcement approaches, it is forecast, will start to look more at baseline characterisation activity, which will reduce the number of GMP transgressions in the medium-term future.

One longer-term change that all experts across the industry panel agree on is the increased collaboration with strategic outsourcing partners and particularly the commercial development of innovations

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68 EXPRESS PHARMA November 16-30, 2013

QbD is seen as being essential to the process of harmonising product and process development, which will accelerate standards, enabling more developed partnerships and strategic uses of outsourcing coming out of academia.

Ajaz Hussain, an independent consultant and formerly of the FDAs PAT team, continued, “Academic partnerships such as that between Novartis and MIT will also be increasingly important over the coming years and academia will play significant roles in both technology and policy. This partnership concept will also expand to relationships with suppliers and manufacturers where there is a need for knowledge-based relationships, particularly in the areas of QbD and FDASIA.” Hussain also believes that manufacturing metrics from CDER will allow regulators to identify data ‘too good to be true’ and decrease non-compliance over the coming years.

Another growing trend is the increased outsourcing across the supply chain and development cycle with industry building symbiotic relationships, commented Chatterjee. He highlighted that a CMOs ability to provide product development services will be essential to companies moving into emerging markets and smaller start-ups looking to tap into the global marketplace.

Botha, however, sees significant risks in too much outsourcing and predicts that lower risk downstream processes such as packaging and logistics will grow, alongside upstream vertical integration of high-risk areas such as APIs: “Outsourcing isn’t always the answer. In some cases it is just abdicating or abrogat-

ing responsibility.”

Venugopal expands on these ideas in his contribution, and believes that the ability to handle increasing volumes of data will facilitate partnerships with reduced risks and enable the global implementation of QbD: “Our ability to increase collaboration and knowledge has increased with our ability to manage data. We can now gather and analyse knowledge to an unprecedented degree”.

His view is that whilst contracting will increase, this will be more strategic in nature across the global supply chain.

Chris Kilbee - Group Director, Pharma, UBM Live commented, “The CPhI Pharma Evolution annual report highlights the main industry trends over the next five years, with tighter regulatory controls and processes (e.g. QbD) and diversification of ingredient suppliers featuring prominently in all submissions.

Harmonising product and development process partnerships are going to be critical to the success or failure of this- which proves the importance of making strategic partnerships at events such as CphI.” Girish Malhotra, President, EPCOT International suggests that alongside these quality and process issues, pharma is likely to change its business model towards developing lower-cost drugs that have a larger customer base, with big pharma revenues increasingly coming

from orphan drugs. However, he also sees risks of an increasingly stringent regulatory environment, with drug shortages envisaged as consolidation occurs amongst weaker players in developing countries.

Prabir Basu, Independent Consultant and former Director of NIPTE, in contrast, sees the greatest threat to the industry coming from uninspected ingredients and argues that it is essential that cGMP be extended to excipient manufacture.

Hedley Rees echoes these thoughts and believes that the current prescriptive approach is not adequately targeting ‘mal-intent in the supply chain’.

One solution, Basu believes, to the regulatory mine field would be for the FDA to implement a ‘trust and verify’-style OHSA Voluntary Protection Program, which would provide flexibility for cGMP sites to make modifications whilst accelerating the implementation of Operational Excellence (OpEx) without fear of shut down. The FDA should also focus its resources on regions with the greatest likelihood of failure.

“Track and trace under FDASIA will also help to drive supply chain improvements but a change in behaviour is also needed to ensure safety.

Industry is far too reliant on regulation as an excuse for not taking the initiative,” Hedley Rees, Principal at PharmaFlow notes.

Another major problem, Basu identifies, is that the current regulatory environment does not incentivise achieving excellence and is rather more focused on non-compliance.

Girish identified a solution to this and believes that the implementation of PAT and QbD will not only lead to higher standards, but will help remove process inefficiencies- leading to global revenue savings of 20-25 per cent.

Emil Ciurczak, Principal, Doramax Consulting also sees the benefits of these new methodologies and states that in 10-15 years’ time, it will be impossible to tell if a site is generic or a branded pharmaceutical facility.

These improvements in standards will inevitably come at the cost of market consolidation, with a generics race underway ultimately leading to a smaller number of larger generics companies. An essential element to improve standards across generics manufacturing will be the adoption of QbR and ever-closer collaboration between the FDA and EMA. Another benefit of QbD/PAT is the ability to vary experimental conditions, which should allow development work to progress from laboratory scale to small scale manufacturing more quickly. Rees supported this, adding that supply chain quality should be brought into the equation at the early development stage, with poorly characterised molecules becoming redundant before development work. He also suggests regulators should raise the bar for CMC filing at the IND/CTA stage to help ensure that only the promising molecules enter the clinic.

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The final area highlighted by several of the panel members, including Malhotra and Ciurczak, is the potential for continuous processing to revolutionise manufacturing with reduced costs, increased sustainability and constantly higher product quality, with the advent of QbD and PAT producing an enabling environment so that batch processing may be a thing of the past.

Kilbee commented, “The remaining findings from our CPhI Pharma Evolution annual report show that over the next few years stringent regulations and practices such as QbD

are prominently shaping the global marketplace. A large number of our experts emphasise QbD in playing an increasingly large role to ensure products are manufactured to consistently high standards of quality that align with all regulatory bodies. But with increased standards does come short-term risks of product shortages, however, in the longer term we can expect huge revenues savings from these techniques, and in as little as 10-years’ time standards at generics and branded sites will be indistinguishable.”

EP News Bureau - Mumbai

Continued from Pg 65

Serving the pharma industry...

Award’ from the Indian Pharmaceutical Congress for their innovation and development. Today, at UEC, machines are equipped with the latest technology. For its customers, United machines are cost effective but are guaranteed with the highest quality, optimum production and en-

sured unconditional service.

UEC is equally focused on being a corporate citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events which help in uplifting the quality of living of the deprived.

The excipients

that'll get you rolling Excipients for Direct Compression Product name

Profil

Median Particle size

DI-CAFOS D 160

Dihydrate

160 μm

DI-CAFOS A 150

Anhydrous

150 μm

DI-CAFOS A 60

Anhydrous

60 μm

TRI-CAFOS 500

Spray dried

100 μm

Excipients for Granulation Product name

Profil

DI-CAFOS D 14

Dihydrate

14 μm

DI-CAFOS D 9

Dihydrate

9 μm

DI-CAFOS A 12

Anhydrous

12 μm

DI-CAFOS A 7

Anhydrous

7 μm

Continued from Pg 66

TRI-CAFOS 250

Powder

5 μm

Neomachine Mfg Co: Aleader...

TRI-CAFOS 200-7

Powder fine

4 μm

Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh, etc.

Neomachine, a professionally managed organisation now has two manufacturing units in Kolkata, which are equipped with state-of-theart equipment like fabrication, machining, assembling and finishing.

The company has been strictly following all the quality control guidelines during manufacturing. The bought-out items are inspected at the manufacturers’ works periodically.

The company has a dedicated team of engineers for providing erection and commissioning and prompt aftersales service to the clients.

The in-house R&D facility is abreast of the latest technology upgradation and the latest developments in 'Coating Technology’. This helps in continuous improvement of the product.

Neomachine also provides IQ/OQ/PQ Qualifications for automatic coating system and are in the

process of getting CE Certification.

Over the years, the company has gained vast experiences in manufacturing 'Automatic Coating System' by interacting with various Indian and multinational pharma and confectionery units based in India.

Products like Cadbury India’s fastmoving product ‘Gems’ and Parke Davis’ ‘Chicklets’ are coated in the systems manufactured by Neomachine. The company also imparts aqueous and non-aqueous film coating and sugar coating technology to clients, who need the expertise.

Neomachine also supplies Hepa Filter for filtration of incoming drying air and Mobile Bed Wet Scrubber for purification of exhaust air, for these companies that need these items. Neomachine being a singleproduct company, manufactures various models of NEOCOTA. The automatic coating machine, gained vast experience in coating technology since the last two decades.

Median Particle size

Budenheim | Business Unit Performance Materials Increasing Performace – Improving Life

69 EXPRESS PHARMA

For inquiries contact: Budenheim India Pvt. Ltd. Phone: +91 (0)11 49651 100 info.indiaoffice@budenheim.com

November 16-30, 2013

AZ_Produktrange_105x297.indd 1

20.04.2012 13:58:24

cover ) I N T E R V I E W

‘The Indian API industry is moving at a sizzling pace’ Pravin S Herlekar, Chairman and Managing Director, Omkar Speciality Chemicals Limited (OSCL), talks about reasons behind getting into API business, in discussion with Sachin Jagdale

What are the reasons behind getting into API manufacturing after spending considerable time in intermediate business?

Over the years, we have had a proven track record of serving top notch pharma companies, domestic and globally, with our niche intermediates. However, in a bid to cash in on the colossal growth potential of Active Pharmaceutical Ingredients (APIs) in the global markets, OSCL envisaged a forward integration strategy to convert our existing intermediates into APIs. In April 2012, OSCL acquired Lasa Laboratories, manufacturing Special veterinary APIs. Located at MIDC Mahad in Raigad District, Lasa Laboratories is a 100 per cent subsidiary of OSCL with state-of-the-art WHO-GMP and FDA approved API manufacturing facility.

The fundamental reason to get into API business was also because the industry is all set to scale higher peaks by 2015, thanks to the global drug off-patent cliff.

Moreover, the role of Indian API manufacturers in the global pharma supply chain is gradually evolving with increasing presence in

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70 EXPRESS PHARMA November 16-30, 2013

synthesis, manufacture of late stage intermediates and APIs. Traditionally, innovators frequently opted to perform final stages of API synthesis in-house or partner with specialised European suppliers while outsourcing early stage intermediates to Indian manufacturers.

However, in recent times, the proven track record of Indian companies in supplying quality products coupled with complex synthesis capabilities has enabled increasing participation in supply of late stage intermediates to innovator companies globally.

Similarly, the API market is in a period of exceptional growth because of the patent expiry factor which is slated to drive the revenues. Small and medium-sized Indian API and bulk drug manufacturers like OSCL have been targeting small and niche segments and have garnered substantial market shares in some advanced as well as emerging markets, effectively competing with larger Chinese and European counterparts on quality as well as scale in the highmargin/ low-volume complex chemical products where completion is less.

Is the patent expiry slated to drive API market growth in India? What should be

The API market is in a period of exceptional growth because of the patent expiry factor which is slated to drive the revenues PRAVIN S HERLEKAR, Chairman and Managing Director, Omkar Speciality Chemicals Limited (OSCL)

the road map for SMEs like yours in future to make most out of the opportunities that patent expiry would offer? Could this be considered one of the sure ‘paths to success’

for Indian pharma companies?

The API industry is poised for a bigger league in the global landscape by 2015 due to the global drug off patent cliff. Indian API manufacturers are likely to benefit as market dynamics undergo a major change in the Asian subcontinent.

India, Japan and China are expected to receive a windfall of about $55-60 billion in the next two years, which is unprecedented.

As per estimates, Indian companies are expected to grab a substantial share of the pie from the regulated markets, such as the US and EU, which are saddled with mounting pricing pressures from low cost providers in developing markets and backward and forward integration by some generic companies.

Today, the Indian pharma market is pegged approximately at ` 1.20 lakh crores, in which API market comprises about ` 50, 000` 55, 000 crores. Out of 10,000 manufacturers, about 70 per cent are into drug formulation, and the rest 30 per cent are into manufacturing APIs. Hence, the patent expiry will provide a significant opportunity for API suppliers and generic drugs manufacturers. It will further

offer multinational pharma companies the opportunity to outsource bulk drugs from India.

Today, the API landscape in India is quite promising due to the robust researchbased processes, low cost operations and availability of skilled manpower. The global economic slowdown further amplified the growth prospects of the API sectors in India, Japan and China, which on the other hand restricted the growth in developed economies such as the US and Europe and helped to fuel the growth in the Asian markets.

API business margins are mainly based on the product and market mix of companies. Today, OSCL has a diversified portfolio of over 200 products, including a range of organic, inorganic and organo inorganic intermediates making it less susceptible to shocks during adverse global market conditions.

Product portfolios with higher share of recently patent-expired drugs enjoy higher margins compared to older commoditised drugs.

Higher share of exports to profitable US and European markets imply better margins. In order to keep abreast with the changes, OSCL has targeted niche segments to garner a large

( market shares in the emerging markets and effectively compete with the Chinese and European counterparts on quality as well as scale.

OSCL has also adopted various novel technologies to reduce the processing time as well as to yield more production. We have also adopted several environment-friendly production processes.

Similarly, OSCL has implemented measures to go green, reduce carbon footprint and cut down on electricity consumption and water. We have measures in place to improve our manufacturing processes, bring down waste from our

In terms of global ranking, India is now the third largest API producer of the world, just after China and Italy API synthesis, dispose off solvents and to improve, save and protect the environment.

China is still ahead of India as far as API production is concerned. Which are the areas where China provides edge over India to API producers?

The Indian API industry is moving at a sizzling pace and we are fast gearing up to cash in on the bright export market prospects in next two years.

In terms of global ranking, India is now the third largest API producers of the world just after China and Italy, and by end 2015, it is expected to be the second largest producer after China.

71 EXPRESS PHARMA November 16-30, 2013

However, in Drug Master File (DMF) filings India is currently ahead of China.

India is much ahead of China in pharma

formulations manufacturing, especially in the area of exports to the regulated markets like, the US and EU. Over 30 Indian companies

THE MAIN FOCUS

are currently catering to exports demand of the US market. However, it is interesting to note that some of the leading global

manufacturers have already set up their formulations manufacturing facilities in India and some more are expected to follow suit over a

cover ) period of time. Hence, fast growing domestic demand for APIs, especially for exports, will drive the business plan of the global API players for India.

Currently, there are two broad categories of markets for the API globally — highly regulated and semi regulated markets. Countries like, the US, Europe and Asia Pacific under highly regulated category with high entry barriers for the global API players because of robust Intellectual Property (IP) regime and stringent regulatory requirements to meet the product quality standards. Such an environment prompts a premium price for the APIs. In contrast, the semi regulated markets, which offer low entry barriers with not so stringent IP and regulatory requirements, attract more number of API players engaging Special in cut throat price competition.

However, a perceptible shift in API manufacturing has emerged from the western markets percolating into the emerging markets such as, India and China. In the Asia Pacific region, Japan and China enjoy the highest market share for API, about 43 per cent and 21 per cent, respectively. Whereas, India accounts for 11.5 per cent, while South Korea holds nine per cent market share. To avoid price erosions witnessed in the US, Indian API manufacturers have started exporting more APIs to Japan.

And so, India has emerged as one of the most-favoured API producing hub globally largely on its credentials as the best quality manufacturer of generic formulations as well as cost competitiveness compared to its foreign counterparts. It’s a fact that Indian companies have excellent chemistry skills due

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72 EXPRESS PHARMA November 16-30, 2013

MTs. We are incurring a Capex of roughly ` 25 crores towards this expansion which is expected to be completed

by October 2014.

to their well-established generics exports industry, whereas Chinese companies are known for their bulk drug and intermediate sourcing.

Secondly, most Chinese firms specialise in the production of low-value, large-volume intermediates and APIs. On the other hand, Indian companies are known for producing high-value, low volume intermediates and APIs. All this well work in favour of Indian companies also because of their reliability and the ability to meet delivery schedules which is a big concern for global drug makers while sourcing from China today.

Stringent regulatory regime in China has caused closure of many units which will surely work in favour of Indian drug companies like OSCL. What are the pros and cons associated with FDI in the pharma industry? How is it going to impact the API industry in India?

The current FDI regime that allows foreign investments in pharma companies has triggered off a hot debate within the federal government as ministry of finance, commerce, and health and family welfare have been reported to be

contemplating to reverse the policy as they fear that continued takeover of Indian pharma companies by MNCs may adversely affect the domestic industry and push prices up, leading to essential medicines becoming more expensive.

The key focus of the present policy is said to put in place a regulatory framework for the drug pricing to guarantee availability of required essential medicines at reasonable prices, while providing sufficient opportunity for innovation and competition to support the growth of industry through generating employment and economic well-being.

However, bulk drugs or APIs does not fully reflect in the essentiality of the actual drug formulation as per the policy. It is therefore a subject of contention for various API manufactures that the ingredients which go in various formulations is not considered as essential for the healthcare needs of the masses. In fact, barely 47 bulk drugs out of the 74 have been notified in the First Schedule. This will surely have a cascading effect on the formulations manufactured from the concerned bulk drugs, which may affect the

availability of many formulations. The basic preamble of pricing of the bulk drug and the formulation will make it more complicated without offering direct benefits to the consumer who is actually affected by the price of the final end formulation (product) made from APIs. I feel that if the policy is implemented in the existing manner, the access to medicine scenario in the country may adversely impact production, availability and prices. India will then have to be heavily dependent for life-saving medicines from the domestic facilities of MNCs or imports.

India is already importdependent for intermediates and critical drugs. Today, over 72 per cent of India’s API/intermediates are imported from China.

In other words, the FDI policy in the pharma sector may weaken domestic capabilities and result in forcing the country to rely on MNCs for life-saving drugs.

What is your current API production capacity and how are you going to build it in future?

The current API production is 100 MTs which is getting scaled upto 600

What kind of policy makeover would you expect from the government in order to make India the leading API producer in the world?

The federal government needs to seriously look into levying anti -dumping duty on bulk drugs from China immediately. It’s a chilling fact that our government levies a low registration fee of ` 2,000 per product for the Chinese pharma companies, whereas China imposes ` 20,000 per product for Indian pharma companies. I feel it is a bizarre irony for API manufacturers like OSCL. The government’s inability and lack of commitment to resolve the issue has snowballed into a major deterrent to the growth of the API production in India. In spite of the fact, the API manufacturers across the country has appealed to the government to take a decision on behalf of this, they don't have the hope that any decision would be taken in the near future.

Further delay in taking a decision could decelerate the API industry growth by 5-8 per cent. Apart from this, another issue is the lack of advanced infrastructure for the pharma sector like setting up dedicated API industry zones. In terms of production, plant moderniation and technology adoption and infrastructure, China is far ahead of India.

India lags in modern industrial areas, environment control and connectivity. Here the government needs to rectify its botched up policy, else we will be in a sorry state of affairs. sachin.jagdale@expressindia.com

(

THE MAIN FOCUS

PROFILE

Meridian Medicare: Conquering new horizons MERIDIAN MEDICARE recently completed its 25th year of existence and celebrated its silver jubilee year. Having grown from a small manufacturing venture in 1987, today the Meridian Group of Companies include nine manufacturing units in Solan providing employment to over 1,000 people. Besides having a nationwide marketing network, they contract manufacture for over 700 big and small companies.

All facilities manufacture pharmaceutical formulations in all sections, capsules, tablets, dry syrups, liquids, drops, beta / non betalactums, sachets, nutraceuticals, herbal and ayurvedic formulations that cover all therapeutic categories. The associate companies are Special in the business of trading in pharma APIs, and manufacturing printing and packaging supplies for pharma companies. Vinod Gupta, Chairman, Meridian Group of Companies is a pioneer of the medicine industry in Himachal.

He is a Member, State Advisory Committee, Ministry of Health & Ayurveda (HP); President of the Bhagat Drug Manufac turer's Association, Solan; Cochairman of the Himachal Drug Manufacturers Association; Vice Chairman of Federation of Pharma Entre preneurs (FOPE); Charter member of Indian Drug Manufacturers Association Northern Board; Executive Member Confe deration of Pharmaceutical Indus tries (CIPI). He is the recipient of many awards including the Udyog Patra by Institute of Trade and Industrial Development, Prashasti Patra

by Bhartiya Ekta Parishad and Arch of Excellence Award by All India Achievers Conference, New Delhi.

EP News Bureau-Mumbai

YOUR PRODUCTION PROCESS FOR TOMORROW Integrated and tailored solu ons for your process with

Consul ng Process Engineering General Planning

CPhI

Implementa on

INDIA

73 EXPRESS PHARMA November 16-30, 2013

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Please visit us at Booth D 48, Hall 6

www.gla .com

P MEC

10%

According to IFR figures, 10 per cent of robots sold in India ended up in chemical industries

As far as we can tell, the Indian corporate culture is quite open to new knowledge and innovative technologies. Thereâ&#x20AC;&#x2122;s a high willingness to invest in sophisticated automatic systems in India Bernd Webel Sales Director, Romaco

A highly repetitive and highly precise process is a good reason for roboticisation. Many robots perform at high speed and are adapted to high-volume processes.

On the other hand, robots could also perform lowvolume operations that completely consume an employee's time Jamly John Regional Manager, German Engineering Federation (VDMA), West India Office

74 EXPRESS PHARMA November 16-30, 2013

Expected annual supply

1,90,000 IN 2016,THE ANNUAL SUPPLY OF INDUSTRIAL ROBOTS WILL REACH MORE THAN 1,90,000 UNITS

P MEC

P Mec SPECIAL

ROBO TRICKS Robotics has revolutionised several sectors, what would be its impact on the Indian pharma industry? Would it prove to be the trump card to drive quality and thereby further progress?

BY SACHIN JAGDALE

I 3

rd

LARGEST

INDIA IS THE THIRD LARGEST MEDICINE MARKET BYVOLUME IN THE WORLD

ndia, the third largest medicine market by volume in the world, is not only growing in size but also technologically. Rising demands from the market, pressure to contain the manufacturing costs and a need to make medicine manufacturing safer and error free have enormously revolutionised the way medicines are being produced. Among all the technological upgradations, pharma industry’s increasing interest in robotic technology for research and manufacturing purposes has been considered as a very significant development.

Applications of robotics Where human capabilities face limitations robotics can take over the task. With increased and improved research activities, the risk of radioactive contamination and

biological dangers grow alarmingly.

Now-a-days almost every operational step in the pharma industry can be assisted by robotics.

“Robotic machinery is being used in almost all areas /divisions of the pharma industry that involves complicated steps, for instance, production facilities, quality assurance testing, packaging, research & development (R&D) as well as in diagnostic applications. Perhaps R&D is an area, especially in new drug discovery, that is worth a special mention,” says Dr Girish Mahajan, Senior Group Leader, Anti-infective Discovery-Natural Products, Piramal Enterprises. He adds, “The discovery of new drugs and taking it up to market is really becoming a rare event over the decades. This needs more and more new compounds to be synthesised and screened, de-replicated.

Screening involves assaying millions of compounds in a short span of time to shortlist the most active ones; so that these shortlisted actives can be taken ahead for further development. Manual testing of

75 EXPRESS PHARMA November 16-30, 2013

P MEC

millions of compounds may take several months perhaps a couple of years, which in turn may decelerate the process of drug discovery. However, today effective use of high throughput screening (HTS) has reduced this time drastically and accelerated the process of new drug selection process. The HTS system uses heavy robotics to handle repetitive and skilled liquid handling.”

According to Jamly John, Regional Manager, German Engineering Federation (VDMA), West India Office, a highly repetitive and highly precise process is a good reason for roboticisation. Many robots perform at high speed and are adapted to high-volume processes. On the other hand, robots could also perform lowvolume operations that completely consume an employee's time. “Robots in the pharma industry are used for handling operations such as measurement, inspection and testing; palletising; packaging, picking and placing as well as for clean room applications. Robots are not appropriate though for every pharma process, and manufacturers should consider certain criteria to determine where to apply this form of automation,” says Jamly.

She adds, “According to the International Federation of Robotics (IFR), global robot sales will increase by about two per cent to 162,000 units in 2013.

The IFR Statistical Department expects that between 2014 and 2016 worldwide robot sales will increase by about six per cent on average per year. In 2016, the annual supply of industrial robots will reach more than 190,000 units. Robots can be found in many industries. In 2012, about 12,700 robots were sold to the chemical, rubber and plastic industries including about 1,710 robots for manufacturing chemical products, pharma products and cosmetics. That means, almost eight per cent of the total robot sales globally end up in the chemical, rubber and plastic industries.

For India, the share is even a bit higher. According to the IFR figures, 10 per cent of the robots sold in India ended up in the chemical industries.”

Check on the cost Pharma industry involves a lot of scientific processes. At different stages, different kinds of machineries are being used to produce the desired products but lot of waste materials are generated as well. The cost involved in such processes and

in the treatment of waste materials leads to increase in the cost of the final product. According to industry experts, if robotics replaces such traditional processes it will help in avoiding unnecessary rise in the cost of drugs.

Jamly explains the overall scenario. She says, “Like other industries, the pharma industry is increasingly concerned with the sustainability of its operations. To improve their sustainability, drug makers are attempting to reduce waste and pollutants, conserve energy and improve efficiency. Robots can help the industry achieve these goals. For example, robots' motors, drives, and gearboxes are 90–95 per cent energy efficient. Hence, robots underpin competitiveness in manufacturing. They are known to save costs, improve the quality of production and working conditions and minimise waste in production. The use of robots in production optimises efficiency as well as quality and helps to limit the workers' exposure to hazardous environments.”

Jamly justifies her point by saying, “Before implementing robotic systems, a company must consider their economic implications. The cost of ro-

Robotics definitely brings down drug prices, however it may not be directly proportional to degree of automation, as drug price depends on several other variables and nontechnical factors Dr Girish Mahajan Senior Group Leader, Anti-infective DiscoveryNatural Products, Piramal Enterprises

bots, like that of other established technology, has been steadily decreasing. Hence, replacing outdated or slower equipment with the flexibility and sustainability of robotic automation makes good fiscal sense. The cost of implementing robots in pilot production amortises itself in a reasonable return-on-investment time. Robots' flexibility allows companies to produce small lots of a drug and to change to a different product quickly without incurring the capital cost of fixed-price automation. This makes it very viable, especially for vendors that are working on genomically targeted drugs and niche markets.”

Mahajan says, “Robotics definitely brings down drug prices, however it may not be directly proportional to degree of automation, as drug price depends on several other variables and non-technical factors. But one thing is sure, it reduces the cost of production as such.”

India-specific challenges As informed by Jamly, in India robotics is still in the process of strengthening its roots.

Though robotics would make a pharma

76 EXPRESS PHARMA November 16-30, 2013

company operationally more efficient it also has some challenges associated with it. “To establish robotics for a particular pharma step, it is very challenging for robotics manufacturing industry, especially if it involves sterile handling of the specimens. Vital among these is the incompatibility of their controller software with existing installed equipment.

This needs periodic upgradation of software versions and that also creates need for endusers to update their softwares on PC,” opines Mahajan.

He feels that such technologies are used by Indian industries at par to pharma companies abroad especially in developed countries. However, Mahajan doubts if there are Indian-based companies who provide such technologies globally in a large extent.

Jamly says, “Although India is one of the strongest growing economies among the Asian emerging markets, there still is a low level of automation. In 2012, robot sales decreased by three per cent to 1,508 units.

Given the applications involved - such as welding, dispensing and material handling – it is likely that about 70 per cent of robot sales ended up in the automotive industry. The rubber and plastics industry accounted for 10 per cent of the total supply and the metal and machinery industry had a share of five per cent.”

She adds, “This global trend towards adoption of robotic automation is increasing in India, but is still in early stages. Automation still being in its infancy in several sectors is a reflection of being in the ‘low value-addition’ zone. India is required to leap-frog to ‘higher value-addition’ manufacturing processes.

The real drive for automation started only in 1997 and India is lagging behind in comparison to the world growth in automation sector. The factors affecting the automation sector in India is the political scenario, the economy conditions prevailing and the social and technological challenges.”

Mahajan is not sure about India's capability to produce

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advanced robotics technology.

However, many players believe that Indian companies are ready to accept technology created overseas. Bernd Webel, Sales Director, Romaco says, “Romaco maintains excellent business relations with numerous Indian pharma manufacturers and contract packaging companies. As far as we can tell, the Indian corporate culture is quite open to new knowledge and innovative technologies. There’s a high willingness to invest in sophisticated automatic systems in India.”

Way ahead According to Webel, the general level of automation will be continuously increasing. He says, “The current GMP standards require a strict monitoring of pharma manufacturing and packaging processes. High product quality and production safety are a must. At the same time there’s a great need for efficient and competitive equipment. Robotic systems therefore have the potential to meet the future challenges of the pharma industry.”

Robotics is going to be among the top most priorities for the pharma manufacturers if they want to survive in the gruelling domestic and global competition. Jamly says, “Robots soon could be critical to drug manufacturers' efforts to reduce costs, ensure consistent product quality, and increase efficiency. Economic conditions are raising the stakes and intensifying the competition in the pharmaceutical industry.

Drug makers are intently seeking ways to reduce their expenses, increase their efficiency, and make high-quality products. Robots can help companies achieve these ends by providing speed, precision, repeatability, and flexibility. Because they can improve discovery, pilot production, and small-scale production, robots can be a particularly powerful foundation for the growing biotechnology industry.”

While endorsing Webel’s and Jamly’s views, Mahajan insists that automation merits naturally has accelerated its

77 EXPRESS PHARMA November 16-30, 2013

own evolution in the pharma industry of India. The future would see much higher amount of automation in all aspects of Indian pharma and give more visibility to India globally.

Despite its initial implementation-related challenges use of

robotics would benefit the company in the long term. In the recent past, some of the prominent Indian pharma companies have been punished for qualityrelated issues. Not completely, but at least to some extent, robotics would help to correct this

problem as well. However, as informed by Jamly, in India robotics hasn't taken off as expected.

So, all said and done, future possibilities are going to be the outcome of present actions. Indian pharma players are wise enough to understand

the importance of robotics.

Though initial investments would pose a challenge, slowly and steadily the Indian pharma industry is going to embrace robotics for sure. sachin.jagdale@expressindia.com

P MEC I N T E R V I E W

â&#x20AC;&#x2DC;Pharma companies and equipment vendors should share a symbiotic relationshipâ&#x20AC;&#x2122; Mack Universal offers a range of solutions targeted at pharmaceutical companies in India.

Some of its leading products include W300 series pharmaceutical grade washers, MSC High Pressure Washer, Deep freezer, Decontamination Chamber, and Muffle Furnace.

Manoj Chaudhari, Proprietor, Mack Universal, comments on market trends impacting the pharma vertical and the role played by modern technology equipment in bringing efficiency and precision to pharmaceutical processes

P Mec S P E C I A L What is the business outlook of the pharmaceutical sector, your key customervertical?

The Indian pharma sector is expected to witness a stiff competition in the coming years with many MNCs entering the market directly.

This is good news for patients as they will get access to the best medicines at the cheapest possible prices. However, for the pharma players, that will lead to a few difficulties.

Retaining the current high pace of growth, staying competitive through innovation, regular introduction of new drugs, and talent retention will be some of the challenges they will face in the near future.

What role does modern technology equipment play in keeping the pharma companies competitive?

Most large pharma

78 EXPRESS PHARMA November 16-30, 2013

companies in India cater to the US and the European markets. To stay competitive in those markets, they need to have high-precision equipment that eliminate the room for human error. High competition in the sector also made these companies conscious about their process and quality standards. As a result, they are looking to invest in the latest technology equipment that assures high quality output.

Modern technology equipment helps the pharma companies to improve their process efficiency. Technology has eliminated the need to physically visit a unit to start or stop a process as these tasks can be accomplished remotely. Technology also helps pharma companies to monitor and analyse the relevant production data such as total product-rejections, error-history, process flow, and packaging. With technology tools, it has also become easier today to generate, store, analyse, and safeguard business critical information, thus mitigating

With technology tools, it has become easier today to generate, store, analyse, and safeguard business critical information MANOJ CHAUDHARI, Proprietor,Mack Universal

risks associated with data loss.

Which flagship products are targeted for pharma companies?

W300 series Pharmaceutical Grade Washers, MSC High Pressure Washer, Deep Freezer (with temperatures down to -86°C) are some of the leading products from Mack Universal targeted at the pharma industry.

These products have been designed keeping in mind aspects such as safety, process integrity, flexibility, precision, quality, and compliance standards, in addition to the functionspecific requirements.

Today, no pharma player can afford to have a drop in quality. If you do not maintain the quality of your products, you will be out of race, and sooner or later, out of business.

Mack Universal offers maintenance and support services to help our pharma clients sustain their highquality standards across production processes and

business functions.

What was the estimated turnover of Mack Universal for the financial year 2012-13?

Our overall group turnover was about ` 100 million, with 20 per cent being the contribution of Mack Universal. For 2013-14, our target is to grow the sales by 30 per cent.

What are the latest technologies in the pharma equipment business that you plan to introduce?

Till the last financial year, we were only into small Quality Control and Lab Equipment. But this year, we will venture into the production-class machinery.

Pharma companies are looking for some upgradation in Process Technology, Inspection, and Packaging Technology. These three, Process, Packaging, and Inspection, will be the areas we will focus on. For instance, we will introduce high-end models in process and inspection technology this year. We will introduce

P MEC only such equipment that will help our pharma customers to improve their production processes and aid in quality assurance (QA).

solutions that aptly address the customer-requirements.

With such symbiotic

relationship in place, the manufacturers like us can invest in technology without

worrying about its sale. We are taking active efforts to make such collaboration

happen by initiating a dialogue with some of our pharmaceutical clients.

What do you perceive as key challenges of the equipment makers and vendors in India?

The small scale units have several challenges to deal with today. The global equipment manufacturers like Bosch and Fette have set up their manufacturing plants in India. While that has opened up avenues in terms of availability of knowledge of new technology in the Indian market, it has also placed tremendous pressure on the local companies.

Moreover, while high competition and long sales cycles continue to bother us, an absence of support from the government adds to our challenges. Due to its fragmented nature, the community of domestic equipment manufacturers also finds it difficult to influence the Government's policy making. We need the Government to come up with policies to specifically support the small scale pharma equipment manufacturers so as to help them sustain and scale up.

Delayed payments and high service demand expectations are the other challenges. We optimise our operations to stay afloat despite constantly diminishing margins due to competition.

What efforts should be taken at the industry level involving the pharma customers?

A collaboration between pharma clients and equipment manufacturers will prove useful for both the parties. It will help us, the equipment makers, to understand the clientsâ&#x20AC;&#x2122; requirements better. The specific inputs and suggestions from pharma customers will enable us to design products and

79 EXPRESS PHARMA November 16-30, 2013

P MEC NEWS

SeerPharma and Labnetworx launch training partnership in India P Mec S P E C I A L LABNETWORX HAS added GMP Training to its extensive range of services by joining forces with SeerPharma Australia to launch the first of many in-depth training workshops. This is a long-term relationship that will deliver a range of high quality training programmes, commencing with introductory and advanced courses planned for January 2014.

SeerPharma is the premier provider of professional consulting and training services to the pharmaceutical, cosmetic, medical device and biological industries in the Asian and Australasian region. With offices in Melbourne, Australia and Singapore, it is well positioned to enter the Indian market.

SeerPharma has a depth of experience and specific knowledge of the requirements for businesses operating in these regulated industries. For well over 20 years, SeerPharma consultants have delivered

world class consulting and training services that have provided productivity improvements and compliance solutions to its clients.

An outstanding reputation has been achieved by SeerPharma in delivering international standard GxP, quality and compliance education to industry. SeerPharma’s training services include public short course programmes, postgraduate award courses in collaboration with world-class universities, GxP e-learning modules and customised enterprise solutions.

“At SeerPharma, we are proud of our achievements in the Australasian and Asian markets. India is emerging as a powerhouse in the pharma and related industries. Its companies and their employees will benefit from training conducted by our experienced personnel. SeerPharma already has a strong connection with India as many of the students who have undertaken our Masters Degree in GMP are from India. Therefore, it makes perfect sense to take our training to India with the

help of a reputable partner in Labnetworx,” says David Spaulding, Training Manager and Senior Consultant, SeerPharma Australia.

“There is no substitute for SeerPharma’s quality training.

It provides a depth of knowledge that just can’t be found in text books or on-the-job training. At Labnetworx, we are looking forward to bringing this training to you,” says Dr Sunil Tadepalli, Owner and Founder, Labnetworx.

EP News Bureau-Mumbai

PROFILE

Mack Pharmatech: Showing positive growth MACK PHARMATECH, a renowned lab equipment manufacturing company, was started in 1999 by Kiran Badgujar, Managing Director, Mack Pharmatech. Since the time of its inception the company has focused on offering internationally accredited and globally compliant equipment to the industry, which has helped the company gain an edge above its competitors. Initially, the company took some time to come up with the final product and all the efforts paid off with the very positive response it received from domestic as well as international pharmaceutical industry.

Mack Pharmatech is the first Indian company to have CE certified lab equipment and manufactures equipment as per the ICH and GMP Guidelines. Today, MACK PHARMATECH has positioned itself as one of the pre-

80 EXPRESS PHARMA November 16-30, 2013

Kiran Badgujar, MD – Mack Pharmatech MD – Mack Auraa, Equipment & healthcare Division

ferred suppliers of Stability Chambers in India and across various overseas markets.

With the expertise, methodology and experience garnered by Mack Pharmatech over the years Badgujar officially opened its doors to

new initiatives Mack Auraa.

These new entities have been established to provide its proven effective business analysis and quality standards compliant services to its customers throughout the world to fulfill their requirements.

Mack Auraa aims at producing wide range of products which are globally compliant and of international stan-

dards. The products include: weighing, moisture analysis, ash determination, ultrasonic cleaners, laboratory consumable atoms, UV spectrophotometer, autoclave and sterilisation, stirrer, mixer and shaker, electrochemistry, liquid handling, flammable safety storage cabinet Mack Auraa is raising its hand in the healthcare sector

as Mack Auraa Drugs to bettering the lives with the help of ayurvedic, herbal, veterinary and allopathic medicines, food-supplements and nutrition. We believe in total customer satisfaction though excellence in technology, research and development and through continues education to our valued customers.

Mack Auraa is dedicated to the highest level of scientific excellence, maintaining high international standards and adherence to global compliance for its entire range of products. The companies are committed to the highest standards of ethics and integrity.

With long-term vision and strong ability, the team remains confident that it will continue to drive growth, achieve its strategic corporate objectives, and emerge stronger in its journey towards global leadership.

P MEC CASE STUDY

ATE: Spearheading sustainable solutions P Mec S P E C I A L WITH A LEGACY of over 75 years in the generic API industry, this success story belongs to one of the leading international supplier of active pharmaceutical ingredients.

With the industry’s broadest portfolio of over 300 API products, this multinational employs over 5,000 professionals at over 20 sites worldwide.

The case study depicts

Result

how ATE achieved the task of treating the complex API effluent with innovative application of anaerobic-aerobic combination for one of its client’s site in central India

Challenge While going for their new factory in Central India, the client was concerned about the treatability of the complex effluent that was expected to be generated out of this unit.

Also the energy cost involved in treating the effluent was a prime concern. One of the

renowned project management companies were consultants to the project.

Solution After a series of discus-

sions with the client and consultant, an anaerobic and aerobic combination was selected. This is considered as a first of its kind solution for pharma effluent treatment.

ATE successfully designed, installed and commissioned a 250 m3/day effluent treatment plant based on anaerobic-aerobic combination.

Following are the advantages of this unique solution for pharma effluent: ● Reduces over 40 per cent COD in anaerobic stage thus reducing the power consumption for aerobic treatment. ● Improves biodegradability of COD entering aeration tank. ● Overall 90 per cent reduction in COD.

GOOD MANUFACTURING PRACTICES & QUALITY ASSURANCE 20th–24thJanuary 2014, Hotel Radisson, Greater Noida The Pharma Industry needs GMP Trained Professionals Attend an introductory & advanced GMP course that helps you adhere to regulatory guidelines & overcome non-compliance.

Designed for B.Pharm/ M.Pharm/ MSc / PhD in Life Science disciplines & working professionals in the Pharmaceutical Industry.

Get the SeerPharma ‘Confidence in Compliance’ SeerPharma is Asia-Pacific’s premier consultancy with solutions across QA, GMP & GxP compliance, training, risk management, validation, IT, productivity and automated quality management systems.

Training conducted by David Spaulding, Training Manager and Senior Consultant at SeerPharma with over 30 Years in the pharmaceutical and medical device industries including senior manufacturing and commercial roles at GSK Australia.

Course Fee: GMP Introductory Course (3 Days) – Rs.16,854/GMP Advanced Course (2 Days) – Rs.13,483/GMP Introductory & Advanced Course (5 Days) – Rs.28,090/(Inclusive of Service Tax @12.36%) Certificate will be awarded to all participants

For details and course content see: http://labnetworx.com/gmptraining http://www.seerpharma.com.au Phone: +91-85273-17888 Email: gmp@labnetworx.com

81 EXPRESS PHARMA November 16-30, 2013

P MEC I N T E R V I E W

‘Essel Propack outlays its pharma market driven strategy’ Essel Propack is one of the largest specialty packaging companies in the world headquartered in Mumbai having 33 per cent global market share in tubes catering to the oral care, cosmetics, and personal care, pharmaceutical, food sectors. Roy Joseph, Regional Vice President, Essel Propack, who is responsible for their business in the India , Middle East & Africa, talks with Usha Sharma about the company’s growth prospects

P Mec S P E C I A L What is Essel Propack’s strategy for the Indian markets?

Essel Propack (EP) first introduced laminated tube technology in India 30 years ago and continues to be the market leader for the last three decades. In the last decade, we have expanded our offerings beyond the oral care segment and have bought new packaging solutions in the beauty care, pharmaceutical, food and industrial categories.

In the beauty care and pharma space, we have launched customised solutions in the last two years with innovative products like Egnite, Fusion, Click-Tube and Elite These solutions are in line with Essel Propack’s overall strategies which are focussed on ‘Elevating Brands and Improving Performance’, which we strongly believe will add immense value to the brand owners and product consumers.

Could you substantiate on your focus ‘Elevating Brands and Improve Performance’ and how it will help your customers?

We are observing a trend in the industry where tubes are becoming the point of sale packaging replacing cartons.

We see this trend gaining more traction with the growth in

82 EXPRESS PHARMA November 16-30, 2013

modern trade in India and continued focus on sustainability. We believe that in this transition we as tube suppliers could contribute in improving the brand perception through design and printing of innovative graphics, surface finish and brand protection solutions, which will help deliver products with superior consumer appeal.

On the ‘Improving Performance’ Part, Essel Propack with its strong knowledge on material science , polymers, molecules is in a position to design, develop and supply customised laminate structures for tubes that will retain the product efficacies and increase product shelf life.

How does pharma tubes fall within the overall market driven strategy?

For pharma products of semisolid formulations like ointments, creams and gels, tubes are the best packaging formats that could be used.

However, like the oral care industry three decades ago, 75 per cent of pharma tubes are in aluminium and only 25 per cent are in laminated tubes. The four important needs that the industry would be looking towards to make this shift are: continuity of supply with shorter lead times; hygiene and good manufacturing practises, comparative prices and product stability.

EP in its pharma offerings

We are observing a trend globally, where Lamitubes are fast becoming the point of sale packaging ROYJOSEPH, Regional Vice President, Essel Propack

have tried to meet these expectations including codeveloping special small tube machines, building clean room tube facilities and investing in R&D to develop new material, laminates that give stability and costs advantage.

We have specialised offerings both for the OTC

drugs as well as prescription drugs and our global footprint and knowledge in supplying to stringent regulated markets of the west are helping us to develop these capabilities faster in India .

Due to new patent procedures, the Indian pharma industry are investing more on research and development (innovation). The industry demands New Drug Delivery Systems (NDDS) and packaging technology for better protection of their formulations (stability) and product differentiation from competition. Essel is the perfect solution provider for such customised developments and innovations with the strength of having a global R&D centre located in the outskirts of Mumbai.

Is there any particular part of the pharma industry where you see a better advantage in using the lamitube technology?

Yes, the sterile tube packaging for ophthalmic ointment and gels where EP gives tamper evident long nozzle tubes. It can be GAMMA processed for sterile formulation packaging.

Does EP’s global presence helps in growing lamitubes business and faster adaptation in India?

EP is associated with leading pharma companies

globally and has experience in doing large scale projects for development of customised packaging, complying with the regulatory norms. EP’s global harmonised manufacturing practises and standard Fitness for Use (FFU) gives benefits to global customers by offering same packaging solutions in different geographies as per their request. Essel develops laminates as per product/ formulation properties to ensure its stability and efficacy throughout shelf life. Essel Propack gives documentation and filing support to customers while registering their products in regulated markets like USDMF. What leverage EP has over other suppliers of tubes in India?

Global presence, CGMP and HMP, USDMF registered plants in India. Class D clean room facility state-of-the-art R&D facility, extractable leachable study capabilities , end to end manufacturing (no outsourcing of componentry), Use of FDA Grade Polymers , patented anti-counterfeiting solution for brand protection are some of the features that EP offers compared to other players in the tube industry.

Apart from the same, it also offers tubes from four tube factories in India for an efficient supply chain. u.sharma@expressindia.com

P MEC I N T E R V I E W

‘We convert an entire IT system in local language’ Jagdish Sahasrabudhe, Chief Executive Officer and Managing Director, LinguaNext Technologies shares the company’s ongoing and future plans with Usha Sharma P Mec S P E C I A L Tell us about the software that LinguaNext Technologies has invented for the pharma sector.

LinguaNext is the market leader in enterprise application language management.

LinguaNext’s innovative technology-based solutions enable any enterprise, mobile or cloud software system to work in any Indian or global languages, seamlessly and with zero changes to the underlying application code.

Today, many pharma companies have invested in

enterprise resource planning (ERP) solutions to automate their transactional and manufacturing systems. In India, Cipla, Dr Reddy's Laboratories, Ranbaxy Laboratories, Torrent Pharma are just to name a few. With Linguify, these companies or their subsidiaries can access

the same SAP system in any Indian or global language without any changes to the underlying SAP system.

Some of the Indian pharma companies are majorly involved in mergers and acquisitions (M&A) and are acquiring companies in Europe/Africa. Linguify will

allow their subsidiaries to work in their local language on the centralised system and that too without any changes to their database, which remains in English. Some companies are exploring rural markets in India and trying to broaden the reach of their drugs within India. In this expansion the use

83 EXPRESS PHARMA November 16-30, 2013

P MEC

of languages comes up.

Our solution will help people who are involved in pharma supply chain and logistics, and whose native language is not English, to work efficiently on the system in their local language. This way the company can get the maximum benefit from their ERP system by increasing the reach and have all its users participate in the business process.

Tell us in detail about Linguify and its importance in today's time?

Indian pharma sector is growing at the rate of 12 – 14 per cent and information technology is expected to facilitate this growth by bringing in manufacturing and supply chain efficiencies, in addition to enabling the domestic pharma players to compete with their global counterparts.

Our product Linguify

provides language localisation to all modules of ERP and other business applications.

Similarly, Linguify provides language localisation to financial systems. On these lines, we also have Linguify for human resource applications.

Employees who are not comfortable in English can access their employee self service portals (ESS) in Hindi or any other Indian language.

Factories or branches which are located in remote places can give opportunity to the local employees to work in his local language on the same system.

How cost competitive is this solution and what are its USPs? Most traditional methods of language localisations need 1+ years and cost in millions of US dollars (or crores of rupees).

LinguaNext’s technology USP is to perform this in 20 per cent

of the time and cost. The main reason why we can do this is because of the USP of not accessing the code or the database of the enterprise application which in turn helps us manage the time and cost required to build and maintain the language solution.

Linguify provides language localisation to all modules of ERP JAGDISH SAHASRABUDHE, Chief Executive Officer and Managing Director, LinguaNext Technologies

Who are your competitors in India and why?

We do not see anyone competing with our solution LinguaNext in India. There are many language service providers who are not offering translation services such as website translation.

Our approach is unique. We convert an entire IT system in local language and document translation is not our focus. LinguaNext technology is a patented one and we have five different patents in this category.

Did you ever face any language barriers while

working in different countries?

Yes we did face the language problem. In most of the European and Asia Pacific countries their local language is still used as an official language. And our solution can help them to interact with their enterprise applications in their native language.

What are the company's future plans?

We have a series of products and product features that are currently in the pipeline to be launched. We will soon be announcing LinguaNext products enabled with phonetic transliteration wherein the text would be converted from one script to another phonetically. We are working on upcoming LinguaNext products for citizen services and mobile platforms as well. u.sharma@expressindia.com

I N T E R V I E W

We have been seeing a Y-o-Y growth of 20 to 30 per cent through expansion’ NM Mehta, Director, Newtronic Lifecare Equipment talks about the company's expansion plan, in an interaction with Usha Sharma P Mec S P E C I A L Tell us about Newtronic’s business journey and its ongoing activities Newtronic was founded in 1980 by myself. After continuous efforts, today Newtronic got transformed from manufacturing temperature controllers to manufacturing sophisticated laboratory equipment for the pharma industry. Our

84 EXPRESS PHARMA November 16-30, 2013

flagship products are stability chambers which are used for determining the shelf life of drug products and drug substances. Apart from this, our other products designed for the cooling chambers, incubators and ovens are used in pharma companies as highly trusted and dependable products. Today, Newtronic has its own premises spanning over 40,000 sq ft at Kandivali, Mumbai. Recently, we have started one more facility at

Umbergaon, Gujarat across 20,000 sq ft.

Why did the company decide to manufacture user friendly stability chambers for the pharma industry?

The Indian pharma industry was going through a phase wherein it required a series of compliance measures to export to international markets.

I understood the need and decided to design chambers

that meet regulatory aspects, mainly ICH, WHO, US-FDA, TAPPI, TGA, JPMMA, MHRA, ANVISA, ASEAN or any other testing standards.

We strongly believe that it is the end-users who finally operate the systems, and if the system is complicated and unsafe to work it is difficult to withstand in the market.

Systems should work smoothly and harmlessly.

With strategic research, initiatives and immense

knowledge, Newtronic started manufacturing stability chambers that are easy to handle with minimum maintenance, and are best suited to achieve the required conditions and comply with regulatory requirements.

How big is the Indian stability chamber market and how is it growing?

The Indian stability chamber market is approximately Rs 200 crores

P MEC

and poised to grow at 20 per cent to 30 per cent year on year (YoY).

How important is the role of stability chambers in the pharma industry?

The primary reason for stability testing is the concern for the wellbeing of the patient suffering from the disease for which the products are being designed. Degradation of unstable products into toxic decomposed products not only results in loss of activity but also may lead to failure of therapy resulting in death.

Hence, stability testing should be done very accurately.

It has become a legal requirement to provide data of stability testing to regulatory agencies before launching a new product commercially.

Stability studies protect the reputation of the manufacturer by assuring that the product will retain its fitness for use with respect to quality as long as it is in market.

Other benefits of stability studies, at developmental stage or marketed products, include providing a database that may be of value in selection of adequate formulations, excipients and container closure system for development of new products.

How would stability chambers play a role in the pharma industry's journey towards automation?

Stability study plays a vital role in the pharma industry. It is always essential to adopt new technology.

We design and manufacture the chambers with advanced features like high â&#x20AC;&#x201C;speed data transfer, PLC based controller with adequate data storage facility, touch screen display with various operations, auto change over to stand by systems, eco-friendly cooling system, range of alarms and same get log with details in point of audit trails, alarm transmission not only in equipment but also at various other places like in software,

85 EXPRESS PHARMA November 16-30, 2013

direct email from the PLC controller, at security gate, SMS to predefined numbers etc. Along with these, we always take care about the safety of equipment, components, samples and human beings.

Presently, how many domestic companies are manufacturing these kind of products?

There are around 30- 40 companies who manufacture similar kind of equipment, out of which two are prominent

and Newtronic is in a leading position.

How much market have you captured and what is your growth percentage?

Almost all major pharma companies are equipped with

our complete product range of stability chambers, cooling chambers, incubators and ovens.

We believe that almost 90 per cent of the tier-1 pharma companies (subjected to stringent regulatory norms)

P MEC

depend on Newtronic chambers for their stability operations.

In terms of growth, we have been seeing a YoY growth of 20 per cent to 30 per cent through expansion of our existing customer base and clinching important deals with new pharma companies and plants.

What is the USP of your products? How cost effective are your products?

Our USP is excellent consultancy in ICH guideline, regulatory and compliance requirements especially during US-FDA, WHO, TGA, UK MHRA and all other audits.

Completely PLC-based operations, ethernet-based software communication and comprehensive fall-back mechanism to ensure 24 x 7 operations, reliable with respect to safety and quality, have maximum service life and minimum maintenance.

These are some of our USPs over our competitors.

Which is your blockbuster product and how much business does it add to the kitty?

Walk-in stability chambers are our blockbuster products.

It contributes to approximately 50 per cent of our total business.

The walk-in chambers are easy to install, with prefabricated panels that can pass through the smaller door at site. It is economical and fits into your budget.

It is available in customised sizes to utilise the maximum place at site and give maximum storage area. Most important, it is eco-friendly and an energy saver.

How many more products are in the pipeline? When would they be launched in the Indian market?

We have launched a chiller base cooling system for

86 EXPRESS PHARMA November 16-30, 2013

stability chambers to save power consumption upto 50 per cent from the presentday values and thus reduce our customers' carbon footprint. Thus we are moving towards green technologies.

We have also launched web-based data loggers and real time monitoring system for mapping and monitoring various parameters such as temperature, humidity, light, differential pressure (DP) and CO2.

We have even launched Walk In chambers with FM200 (Inert gas dispersion) system and with Rockwool (Mineral wool) insulation.

And we are happy to state that the market response has been overwhelming.

Tell us more about the company's Direct HUMIDITY display and control technology? How is it better than the dry and wet bulb chart?

We used German based Rotronic or Testo to make high quality temperature and humidity combo sensors.

These sensors have fast response time, rugged and reliable.

Dry and wet bulb chart is a very old technology and nowadays it is obsolete.

What is the customer base of Newtronic and how are you planning to add to it?

We are supplying our products to almost all major Indian pharma companies.

Presently our client list has 300 active clients record and in the near future we have an aggressive plan to double the existing number â&#x20AC;&#x201C; a feat that seems achievable!

What are the services that you offer to your customers?

We are involved in every stage with the client, from implementation to completion of project. We understand and analyse the client requirements and

We believe in research and development.

Our constant focus on technology innovations and design excellence has made our products a trendsetter and leader in all respects NM MEHTA, Director Newtronic Lifecare Equipment

accordingly offer the most suited of our products. We have appointed professional and well qualified sales and service team to provide timely support to our clients.

We keep the response time to the minimum. Apart from these, we are also providing online support to our clients.

Documentation is a critical part in the pharma industry. We provide all important documents including qualification documents, certificates and SOPs which help users to operate the machines properly.

Newtronic is known for its capability design, tell us more about it?

We believe in research and development. Our constant focus on technology innovations and design excellence has made our products a trendsetter and leader in all respects.

Our advanced product features like ethernet communication, auto switch over PLC controller, alarm types, logging and transmission make our products user friendly and help the users during audits.

Our skilled R&D team diligently strives to bring excellence and perfection in what we do. Our chambers are eco-friendly and give maximum storage area.

We have supplied more than 6000 stability chambers, moreover we have manufactured and supplied the chambers with capacity of 1 million litres and above.

Our new concept of 'Gogreen' is being implemented successfully.

What are the current trends and opportunities in the market and how is Newtronic gearing to optimise them?

One of the latest trends that we have noticed is outsourcing of stability operations by US and European pharma giants to cost-effective destinations like India. We have noticed that we are the preferred vendor in such outsourcing operations wherein we work very closely with the projects team of US and Europe from the very beginning and facilitate the complete outsourcing of stability testing in a smooth and efficient way.

We are expanding our business continuously.

What is the manpower strength of the company and do you have plans to scale up?

At present, approximately 200 people are associated with Newtronic.

All our employees are well qualified in terms of their departmental activities. On a regular basis, we conduct training and grooming programmes for our employees which help them to understand our products and the company's progress. It also helps them to understand and improve their individual responsibilities. Going forward, we anticipate that as business grows we would definitely require more people.

How large is the Newtronic's international presence and which are the new markets that you are planning to tap?

Internationally we have an active present in more than 40 countries. To support our clientâ&#x20AC;&#x2122;s in-station we have appointed channel partners in various countries and provide training to their technical persons periodically. We also provide online support to our clients which help them to resolve their problem without major hassles.

What was the company's turnover in the last fiscal and what are its projections for the current fiscal?

In the last fiscal, the company's turnover stood at Rs 400 million and this year we are projecting to touch more than Rs 500 million.

What are the company's corporate plans for 2013-14?

We are looking to expand our product range and manufacturing activity. We also look forward to OEM business for multinational companies and collaborations with other reputed brands. u.sharma@expressindia.com

P MEC INDUSTRY INSIGHT

As the Indian pharmaceutical industry gears up for challenging yet exciting times ahead, the pharmaceutical machinery manufacturers have been pushed beyond their limits to innovate or perish. An insight from ACG Worldwide P Mec S P E C I A L THE PHARMACEUTICAL machinery industry grew tremendously in the 1970s, thanks to the government’s introduction of high import duties to deter increasing foothold of European manufacturers and encourage Indian manufacturing. Since then, the industry has progressed in leaps and bounds as pharma companies got easy access to cost-effective machineries, giving the Indian pharma industry a huge boost.

Today, against the global backdrop of numerous blockbuster drugs going off-patent, the Indian pharma industry has gained increased prominence.

The global pharma giants find it increasingly necessary to not only offer affordable medicines, but make them accessible to regions such as Africa. According to McKinsey’s report titled, 'India Pharma 2020,' the Indian pharma market will grow to $55 billion by 2020, not just in terms

87 EXPRESS PHARMA November 16-30, 2013

® Trademark of The Lubrizol Corporation © 2011 The Lubrizol Corporation

Top trends to shape future of Indian pharmaceutical machinery industry

Carbopol® polymers are highly efficient gel matrix formers for controlling drug release in solid dosage forms. They offer versatility and flexibility… a winning combination.

Processing Versatility n Ability to choose various manufacturing technologies n Available in both powder and granular forms (Carbopol® 71G NF polymer) Flexibility n In modulating drug release n In formulation - Actives with different properties can be formulated to achieve various extended release profiles

Carbopol® Polymers High Performance Pharmaceutical Ingredients

Efficiency (low total polymer level) n Enables smaller tablet size n Potential formulation cost savings Synergies with other commonly used controlled release excipients

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P MEC

Legacy 6100 (output: 400,000 tablets per hour) has been at the forefront in adding Multi-Unit Particulate System (MUPS) capabilities.

Blister packing and cartoning

Securefill 12 T

Destiny 8100

SECUREFILL 12T, was built for this cause.

Tabletting

B45 + K120i

of scale but also volumes. This, in turn, will push pharma machinery manufacturers beyond their limits to innovate, offer advanced technologies, and yet maintain a competitive advantage (over European manufacturers) in terms of cost.

One such pharma manufacturer is ACG Worldwide. With over fifty years of experience, the company offers a wide range of manufacturing and packaging solutions to the global pharmaceutical industry. Its offerings under pharma machinery include encapsulation machines, tablet presses, blister packing and cartoning machines.

Encapsulation Capsules, the other most dominant form of oral solid dosage, are elegant, portable,

88 EXPRESS PHARMA November 16-30, 2013

and easy to use as well as easy to administer. As compared to tabletting process, which requires pressure to compact powder into tablet resulting in high loss of costly APIs, there is no such wastage in a capsule-filling process. Besides manufacturing standard encapsulation machines to fill powders/pellets, ACG understands the criticality of certain drugs that need to be filled in liquids. Fluidocap, a range of encapsulation machines for filling liquids and band-sealing liquid in hard capsules, is a latest from ACG, offering an output ranging from 40,000 to 70,000 capsules per hour.

In addition, pharma companies seek customised attachments on their existing encapsulation machines to offer combination-filled capsules. By

allowing gentle dosing of granules, pellets, powder, mini and micro tablets, capsules, and softgel, all in one capsule combination, pharma companies have found increased patient compliance due to ease of administering and attractive appearance.

Today, about 50 per cent of new chemical entities in the pipeline are highly potent, with sales for high-potency pharma ingredients expected to take off majorly. Most of the oncology drugs, opioids, hormonal agents and prostaglandins fall under this category. This calls for development of containment capsule-filling technologies, which not only protects the environment but also the personnel handling these potent drugs. ACG’s high-containment special purpose automatic capsule-filler,

Although the operating principle and fundamental design of a rotary tablet press has remained so for the last few decades, pharma machinery manufacturers have made multiple machine design improvements to cater to challenging requirements of the future.

Features like an interchangeable turret system, virtually tool-less design and automatic dual micro-dosing lubrication system were introduced as special features a few years ago, but are standard requirements for today’s tabletting machines.

ACG’s Destiny 8100 (output: 1 million tablets per hour) has the capability to produce bilayer tablets with the help of a retrofittable kit. Pharma companies across the world are treating different ailments in a patient at the same time or administering multi-drug therapies for a single illness through bilayer tablets.

They are also being considered for controlling release profiles of separate incompatible APIs or administering fixed dose combinations of different APIs. In addition, ACG’s high-speed highvolume tabletting machines

Packaging technologies such as blister packing and cartoning show considerable potential for growth. Today, packaging machinery manufacturers are facing stiff competition on two fronts price (from Chinese manufacturers) and quality (from European manufacturers). ACG, through its vast experience and strong focus on innovation, has overcome these challenges to a large extent. Offering blister packing and cartoning machines such as B45 and K120i respectively for pharma as well as several non-pharma applications, ACG has demonstrated capabilities such as speed, reliability, cost-effectiveness, and compactness.

Equipment manufacturers like ACG specialise in both labscale machine models and commercial equipment support the industry with technical and development support for scale-up.

However, in areas where ACG has not been able to directly address the needs of the Indian pharma industry, it has tied-up with a few global manufacturers to bring their class-leading technologies to India. Today, ACG’s pharma machinery partners include Pharmagel (softgel encapsulation), alphaphoenix (cGMP washers), Truking (sterile injectable machineries), Azbil Telstar (Lyophilization) and Dara (syringe filling & closing lines), while packaging machinery partners include TGM (flow wrapping), Effytec (horizontal form fill sealing), PFM (vertical form fill sealing) and shrink wrapping (Autopack).

As the generics boom kicksin, pharma companies worldwide look towards experienced partners like ACG Worldwide to offer best-in-class solutions as well as cost-effective methods of producing effective and affordable healthcare.

(ACG Worldwide’s will have its booth no. H34+I34 in Hall no.

V, at P-MEC India 2013)

P MEC I N T E R V I E W

‘The main challenge is to provide cost-effective solutions’ Vinayak Savadi, Managing Director, Coesia India speaks with Usha Sharma about the company's growth prospects in India P Mec S P E C I A L Coesia has been operating in India since almost four years.

Tell us about the company's experience so far?

Coesia had set up its base in Pune in August 2009, with the aim of providing support to other Coesia Group of companies operating in the strategically crucial Indian market, including GD, ACMA VOLPAK, NORDEN, HAPA, LAETUS, FLEXLINK and GDM. Coesia customers are leading players in health and beauty, consumer goods, tobacco, aerospace, racing and automotive industries. The group consists of 13 companies: ACMA VOLPAK, ADMV, CIMA, CITUS KALIX, FLEXLINK, GD, RA JONES, GDM, HAPA, LAETUS, NORDEN, SACMO and SASIB. The group has 85 operating units (52 of which are production facilities) spread across 28 countries. Of these companies, the ones relevant to the life science and healthcare industry are FLEXLINK, HAPA, LAETUS, NORDEN and SACMO. FLEXLINK is the leading provider of production logistics solutions to manufacturing industries, within the automotive, electronics, healthcare and fast moving consumer goods segments.

HAPA manufactures ‘on demand’ printing systems for pharma and cosmetic packaging industries. LAETUS produces on line packaging security and vision inspection systems for the pharma

industry to verify presence, completeness and correctness of packaging materials and drugs. NORDEN designs, builds and supplies fully automated tube filling systems covering all speeds and applications within various segments: pharma, cosmetics, toothpaste, food and industrial.

SACMO designs complete packaging machinery lines and supplies refurbishments of existing machines, maintenance on customer’s site, retrofit of machines in production, second-hand machines, customer training, manufacturing of machine parts, emergency service for part manufacturing and assembly of complete lines.

What challenges have you identified and how do you overcome it?

The main challenge is to provide cost-effective solutions to improve packaging’s environmental footprint – it is a top goal across geographies.

But to overcome this, we’ve made great strides on the journey by closely collaborating with the customers. We have put our packaging portfolio and global development of network to work on science-powered innovations to tackle these tough demands.

Presently, how large is your clientele base? How has the Indian operation helped your clients to have customer friendly services?

Coesia's customers are the leading players in food, pharma, personal care and cosmetics, tobacco, healthcare.

The presence of Indian

VINAYAK SAVADI, Managing Director,Coesia India

technicians will help in faster and better understanding of the specific requirements of our customers. In recent years, Coesia has notably reinforced its presence in the Indian and overseas market, installing lines for a range of products into various sectors - from machinery for packaging sauces and drinks for the food industry to packaging machinery for the cosmetics, chemical and pharma industries.

Coesia provides sales, technical and maintenance services to its customers. After active plan identification for supply chain, training of the technicians for machine assembly and set up, Volpak has started its commercial production of HFFS and VFFS machines in India at its manufacturing facility located in Pune.

GD has also started its commercial production and gained specialisation in manufacturing of advanced automated machinery. Coesia India has regional branch offices in Bangalore and Delhi.

What cost effective services do you offer?

Coesia specialises in providing solutions for companies mainly in tube filling and cartoning machines (Norden), horizontal and vertical form filled sealed machines (Volpak), conveying systems (Flexlink), online vision inspection system (Laetus) and printing systems (Hapa) and Advanced Automated Machinery (GD).

Many large pharma companies rely on us for high speed, proven, highly efficient machines. We have strong, well trained after sales service engineers in India available for these machines. The opening of the Pune base also aims to reinforce one of the group’s hallmarks, namely its ability to work directly with the client companies, to listen to their requirements and to develop new solutions to meet their specific needs. The presence of Indian technicians will help us in understanding the specific requirements of our customers and provide quicker and better solutions to meet their requirements.

Coesia India had a team of 100 qualified people. 3000 square metre clean environment assembly shop including spare parts warehouse, technical office and highly sophisticated ERP system based at Chakan, Pune, Maharashtra.

Tell us how the Indian operations have helped the entire group to grow?

Main aim of the Indian operations is supporting other

Coesia Group companies operating in the strategically crucial Indian market, including G.D, ACMA VOLPAK, NORDEN, HAPA, LAETUS, FLEXLINK, R.A. JONES and GDM. This region created specifically to fulfil one of Coesia’s primary objectives: to better exploit the opportunities offered by potential synergies between its component companies, in order to meet the requirements of diversified clients in a better way. This will be one of the key aspects of Coesia’s strategy to consolidate its global technological leadership through its presence in the most important local markets.

Presently, how many new products are in the pipeline?

Range of products -Tube filling & cartoning machines, Flow wrappers for soaps & confectionery, Filling lines liquids, HFFS & VFFS machines, machines for hygiene disposables, tea bag packing machines, conveying systems, online vision inspection systems and printing systems for pharma and cosmetics, tea packing lines, lipstick fillers and packing machines.

What plans have you set for Coesia India?

The plan for Coesia India is to grow sustainably with a long-term focus on customer centric and innovative solutions, and living with core Coesia values - respect, responsibility, knowledge and passion. u.sharma@expressindia.com

89 EXPRESS PHARMA November 16-30, 2013