Modern Pharma - 1-15 March 2013

Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) granted permission to PharmaSecure for starting operations in Nigeria. PharmaSecure, which has been in India since 2009, will now be able to implement its high volume and cost-effective SMS text authentication services in Nigeria, Africa’s largest pharmaceutical market. PharmaSecure’s services will help industry dramatically scale

up compliance with NAFDAC’s new regulations and extend life-saving authentication capabilities to millions

of Nigerian consumers.After a recent trip to

Nigeria, Nathan Sigworth, Co-Founder and CEO, PharmaSecure, said, “I have been deeply impressed by NAFDAC’s commitment to protect consumers from fake medicine, and my team is proud to bring our experience and

technology to the effort. We look forward to offering Nigerian

consumers the same protection we currently provide millions of Indian consumers.”

In addition, PharmaSecure is the first and only such service based in India that enables Indian manufacturers to achieve their Director General of Foreign Trade track-and-trace mandate as well as comply fully with Nigeria’s new regulations pertaining to SMS text authentication requirements. In doing so, PharmaSecure remains at the forefront of protecting India’s reputation as a world-class producer of high quality, affordable medicines.

In Conversation With 12Ichiro Matsui

Governor of Osaka, Japan

Special Focus 14Infrastructural challenges

and opportunities Need to strengthen the base

Automation Trends 20Radar level management

Cost-effective, reliable solution for process industry

Roundtable 18 Should nanotechnology products be regulated?

Venus receives nod for four plants from Australian authorityDrug firm Venus Remedies has received approval from Australian authorities for four of its facilities, thus enabling the company to export products from these facilities to Australia.

The company has received GMP approval from Therapeutic Goods Administration (TGA) Australia for four of its facilities - cephalosporin, carapenems, and oncology liquid and oncology lyophilised, Venus Remedies said in a statement.

Venus has already filed dossier for meropenem, which is on the verge of registration and TGA approval of facility will further expedite the process, it added.

“We are planning to enter this market through strategic tie-ups with local players, where huge market potential is forecast for docetaxel single vial, gemcitabine, topotecan, irinotecan, imipenem cilastatin,” Pawan Chaudhary, CMD, Venus Remedies Ltd said.

In the Asia Pacific region, Australia is a lucrative market for pharmaceutical industry, due to its growing and ageing population, excellent access to medicines and fast-recovering economy.

Unichem plans to sell drug unit to Mylan for $ 30 million India’s Unichem Laboratories plans to sell a drug manufacturing plant located in central India to a unit of US-based Mylan for ` 1.6 billion ($ 29.7 million).

The deal is subject to the execution of a definitive agreement between the two drugmakers and regulatory approvals, Unichem said in a statement.

Vivimed Labs to propose acquisition of Finoso Pharma Hyderabad-based Vivimed Labs Ltd has proposed to acquire city-based Finoso Pharma Pvt Ltd, a pharmaceutical development services company. The acquisition will be done for a total consideration of ` 15 crore with cash, stock and deferred payment, and will be debt free, according to a company’s statement. After acquisition, Finoso will become Vivimed’s R&D unit to support innovators, generics and licensing efforts. With a state-of-the-art facility in Alexandria Techno Park in Hyderabad, Finoso had recorded a revenue and EBITDA of ` 5.2 crore and ` 1.6 crore, respectively, in the last financial year.

1 - 15 M a r c h 2 013 I Vo l 1 I N o 17 I `10 0

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PSM India pushes for uniform regulatory standards for medicines with tracing and tracking system

Partnership for Safe Medicines (PSM) India released a draft-based methodology on February 15, 2013 at the India Habitat Centre, New Delhi, for public comments and wide circulation among all the stakeholders, prior to its official launch. This proposed innovative initiative will be launched as a pilot to study the extent of spurious and not-of-standards medicines in India and adopt policies to ensure safety and quality in the supply chain.

For the first time in India as a pilot, patients can get their medicines tested in accredited government-approved laboratories at extremely low cost with support from PSM India Initiative. Speaking at the meet, P D Sheth, VP, International Pharmaceutical Federation, said, “This will establish trust on the quality and existing regulatory standards between the manufacturers and the consumers.”

PSM India Initiative s t rongly demanded formulation of global best standards for exported and domestic drugs made available in the supply chain through a robust detection technology to promote universal product identification system under the Indian Drugs and Cosmetics Act. And enable consumers to distinguish between spurious and genuine medicines.

According to a PSM India Report on ‘Patient Safety and Drug Detection Technology’ by Keshav Desiraju, Secretary, Ministry of Health and Family Welfare (MoHFW), it was further

revealed that India has more than 10,000 manufacturers of pharmaceutical products but few qualify the standards of Good Manufacturing Practices (GMP).

“The real challenge is to change the mind set of the small scale manufacturing units and make them understand that manufacturing good quality medicines will fetch profit and bring good return on investments rather than perpetually living under the threat of the law enforcers or in the mercy of the unscrupulous traders/retailers,” said Bejon Misra, Founder, PSM India.

The report of the International Workshop held in India in September 2012 further emphasised that 2D bar

coding and a unique universal product identification system should become mandatory under the provisions of the existing Indian Drugs and Cosmetics Act. There are also no provisions relating to the same for imported drugs, which should also get included into the existing law. To facilitate efficient drug recalls, global standards and best

regulatory practices, India must adopt a sound track & trace system across the supply chain. This will improve tax collection from pharmaceutical products and reduce drastically not-of-standards or spurious medicines from the supply chain.

Government of India should also expedite the process of implementation of effective ‘track & trace’ systems already made mandatory for all products meant for exports and domestic products which are under price control. The technology to be selected should be vendor neutral, based on best global standards, simple in implementation and affordable, especially for the small

scale manufacturers.Adequate reference standards

need to be made available to laboratories to keep up with new types of formulations and Indian regulatory officials should be invited as observers in the inspections of manufacturing sites by European Union, US FDA and other country regulatory agencies.

Efforts shall be made to harmonise prevalent state and central government regulations to facilitate compliance on varied traceability and

recall requirements in a uniform manner following open, global and interoperable standards. Service providers and the patient groups shall play a major role in educating consumers about spurious and not-of-standard quality drugs with active support from Government of India.

Sigworth

Desiraju (4th from the left); C P Singh, Chairman, NPPA (5th from the left); Mishra (6th from the left) inaugurating PSM India’s International workshop on ‘Patient Safety and Drug Detection Technology’

PharmaSecure to offer SMS text drug authentication service in Nigeria

CONTENTSIn Conversation With 12Ichiro Matsui Governor of Osaka, Japan

Event Preview 24 8th Nutra India Summit Set to further the Indian nutraceutical growth strory

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18.Senior Editor: Manas R BastiaPrinted at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition.

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Highlights of Next EditionSpecial Focus: Anti-counterfeiting

REGULAR SECTIONS5 Editorial / Guest Editorial

6 News, Views & Analysis

21 Projects

22 Tenders

23 Event List

25 Book Review

26 Products

28 Marketplace

29 List of Products & Advertisers

20

12 13

15

13Exporting to CIS, African and LatAm countriesTapping the regulatory benefits

Special Focus Pharma SMEs

Insight & Outlook

Facility Visit 16 Enaltec Labs Treading the treacherous research path successfully

Interface T S Jaishankar Managing Director, Quest Life Sciences Pvt Ltd and Chairman - SSI, CIPI

Automation Trends Radar level management: Cost-effective, reliable solution for process industry

Interface Vincent Jeanguyot Project Manager, Intertek

14

15

www.modernpharma.in

Infrastructural challenges and opportunities Need to strengthen the base

Roundtable Should nanotechnology products be regulated? 18

20

19

5Editorial

Indian Pharma: Set for a ‘Big Bang’…

EditorialAdvisory Board

Ajit SinghChairman,

ACG Worldwide & Head, ISPE

Dr Abraham PataniPast President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G NairIPR Consultant & Advisor

Dilip G ShahChairman, IGPA &

Secretary General, IPA

Daara PatelSecretary General, IDMA

As a part of the gradual maturing process, highly fragmented industries undergo strategic right sizing by various organic and

inorganic means to ultimately attain the status of a highly organised entity. Indian pharmaceutical industry is no different and seems to be experiencing its share of the consolidation curve of late. From a market size of $ 8.4 billion in 2006, the domestic pharma sector has surged past $ 14 billion in 2011 and is expected to become bigger as MNCs enter this arena.

In this context, a recent report by GBI Research assumes significance for several stakeholders of this industry. Titled ‘Indian pharmaceutical market outlook – Enhanced purchasing power, rural market penetration and expanded access to healthcare attracting big pharma investment’, this report provides an in-depth analysis of the latest trends, issues and challenges facing the Indian pharmaceutical market.

According to the report, M&A activity has been substantial in recent years with numerous deals getting signed between 2007 and 2012. Company partnerships have also been a common phenomenon within the Indian pharmaceutical market, with approximately 400 partnerships being formed during the 2007-2012 period, the majority of which were valued at above $ 100 million. Suffice to say, the growing number of consolidations and in-licensing agreements between MNCs and Indian companies underlines the rising reputation of the country’s pharmaceutical market.

With the domestic demand drivers such as 100 per cent Foreign Direct Investment (FDI) in pharmaceuticals, rising income of the middle-class population, changing patent laws, low-cost skilled labour and low-priced infrastructure in India, the pharmaceutical market is projected to grow at a Compounded Annual Growth Rate (CAGR) of 12-13 per cent during the 2011-2018 period. In particular, branded generics are likely to become more prevalent in the sub-continent as many global MNCs compete with each other to launch new products after their patents expire.

Going forward, as the MNCs’ R&D operations into the industry continue to grow, the trend of M&As is expected to be further strengthened. As a result, more such deals and acquisitions are likely to be the order of the day in the near future. Furthermore, factors such as changing disease patterns, increasing focus on universal healthcare, rising income levels, reduced out-of-pocket expenditure, growth of new products such as generics and biosimilars, etc are expected to drive this growth. However, despite these domestic drivers, the challenge before the country still remains in providing a high level of healthcare across the country.

Exporting to emerging markets: Hurdles and the way forward

I ndia, apart from all the turmoil that it has faced internally, and the recession that has hit Europe and the western world, has carved out a

niche for itself in the global market. This achievement can be largely attributed to pharmaceuticals in which the country has achieved self-sufficiency of sorts. However, the SME sector should be the backbone of the staggering task of achieving the production capacity of $ 40 billion by 2020 so that the industry can prepare itself for the ambitious export targets being outlined for the industry to achieve.

In order to plan a robust export thrust, it is quintessential to introspect on the hurdles that the industry is facing: regulatory obstacles, WHO-GMP manufacturing facilities that need upgradation, adequate domain knowledge of emerging markets and their trends, novel and innovative generic formulations, human resource pool to match global expectations and the packaging quality of Indian products has to get a real fillip in terms of International standards.

Although crossing these hurdles and ensuring that the exports achieve the desired growth would be a daunting task for the Indian pharma industry, it needs to work on the following core issues on top priority.

SME sector manufacturing facilities have to be upgraded from a mere 800 in number to at least 2,000, so that WHO-

GMP manufactured products of high quality are exported to the emerging markets. The production capacities have to increase manifold. More sections have to be added in manufacturing units, and most importantly the number of betalactum and cepahlosporins facilities has to be increased to garner a substantial share of the antibiotics segment.

The regulatory compliance is becoming stringent and stressful, therefore there has to be a central pool of regulatory experts who can create model acceptable dossiers in Common Technical Dossier (CTD) and ASEAN Common Technical Dossier (ACTD) and also country-specific guidelines for various countries that are in the radar of our pharma exporters.

The image makeover of corporate Indian pharma needs to be sold to the foreign clients and regulators and hence it is pertinent to conduct more B2B meetings, take delegations of business men and conduct road shows, etc to solicit domain knowledge and foster export growth by creating robust strategic partnerships.

Pharmexcil has been doing a pretty decent job in building a base and foundation for the Indian pharma industry on foreign soil and Dr Appaji and his team’s endeavour should also comprise opening foreign offices with help of Indian business associations and our foreign missions abroad to gather and increase domain knowledge

and foster better relations with local authorities and buyers.

The pharma exporters should unwind themselves from trading of common generics at low margins to building brands that will render continuous top lines with attractive bottom lines to guarantee long term growth in most emerging markets. The industry should also break away from the monotonous range of common generics and run-of-the-mill formulations and graduate to super generics or innovative formulations for health and lifestyle products. This gives the customer a broad choice to select from and helps both partners to work with adequate margins that take care of marketing and promotion to boost market demand.

A transnational human pool of experts should be another target in the horizon as this will help the industry to obtain expert advice on do’s and don’ts that normally comes at a great cost, which is not often affordable by the SMEs.

Thus, the global village is getting crowded by the day with MNCs and regional players from all over the world, and hence, the Indian pharma industry needs to tighten its belt and get down to some serious brainstorming and prolific thinking or else we would miss the bus come 2020!

Anup Banerjee CEO-Global Business,

Cian HealthCare Pvt Ltd

Guest Editorial

Manas R Bastia [email protected]


A national symposium on pharmacovigilance was organised by the Indian Pharmacological Society (IPS) Bangalore Chapter on February 16, 2013 at Indian Medical Association Hall, Bengaluru. Eminent pharmacologists such as Dr Y K Gupta from AIIMS, New Delhi; Dr Bikash Medhi from PGI, Chandigarh; Dr Dinesh Kumar from NIN, Hyderabad; Dr Rajan Mittal from Dr Reddy’s Laboratories, Hyderabad and Dr Seema Rajsingh from Biocon, Bengaluru delivered the talks. Symposium was well received by the delegates from both academia and industry from various states of India. In his talk, Dr Prakash Diwan, President, IPS, stressed on the need of active participation of young pharmacologists in collecting reports of adverse drug reactions. Sessions started with a talk by Dr Gupta. He discussed about

the history, basic concept of pharmacovigilance and pharmacovigilance programme of India. Dr Medhi oriented the delegates about the need of pharmacovigilance in national and international scenarios. He shared information about various fellowship opportunities on pharmacovigilance around the world. He also briefed about the need and ways of teaching pharmacovigilance to students. Dr Kumar spoke about pharmacovigilance of alternative system and natural medicines in India. He stressed on the need of monitoring various products that claim to have certification from NIN, Hyderabad, as the Institute usually does not issue such certificates. He also warned about the various natural products that claim to have fat reducing effects. Dr Mittal talked about the pharmacovigilance of vaccine, biosimilar and medical devices.

He also introduced the concept of eco-pharmacovigilance and highlighted about the recent developments in this area. He mentioned about the concerns related to the decreasing population of vultures due to consumption of diclofenac detected in dead animals. He also discussed about the contamination of various water sources by drugs excreted by human beings. He emphasised about ‘green pharmacy’ and mentioned about biodegradable drugs. Dr Rajsingh discussed about the industry process of managing adverse drug reactions and spoke about periodic safety update reports and regulatory challenges.

“We expect more such discussions from all our branches and I congratulate Dr Raju Koneri and his team in Bengaluru for this well organised, enjoyable and educational meeting,” said Dr Diwan acknowledging the

efforts of IPS Bangalore Chapter.Dr Koneri, the President

of IPS-Bangalore Chapter and organising secretary, 46th Annual Conference of Indian Pharmacological Society (IPSCON 2013) made the official announcement about the national conference. He mentioned that the conference will be jointly organised by the Bangalore Chapter of IPS and Karnataka College of Pharmacy during December 16-18, 2013

at the NIMHANS, Bengaluru. He said, “IPSCON2013 will be a gala gathering of pharmacologists from across the globe. We are expecting at least 3,000 delegates and we anticipate presentation of more than a 1,000 research papers.”

Seminar provided valuable insights on current trends in pharmacovigilance and strides required for grooming this field in India.

Hardik Ashar

Reckitt Benckiser (RB) & Bristol-Myers Squibb (BMS) have announced a three year collaboration agreement for a number of market-l e a d i n g O T C consumer healthcare brands in Brazil, Mexico and certain other parts of Latin America, with an option to purchase at the end of the three year period. Under the terms of the agreement RB will initially pay BMS $ 482 million to enter into the arrangement, which includes personnel, supply contracts and an option to acquire legal title to the related intellectual property at the end of the collaboration period, based on business performance.

Rakesh Kapoor, CEO, Reckitt Benckiser, said, “This transaction creates a material consumer healthcare platform, infrastructure and distribution network for RB in both Brazil and Mexico. As such it is an important step in building our consumer health care presence in Latin American emerging markets.”

“This agreement allows us to increase our focus on the launch and commercialisation of our innovative portfolio in these important markets in Latin America,” said Charles Bancroft, Executive Vice President, Intercontinental Region and Japan and Chief Financial Officer, BMS.

The key brands included under the agreement are Naldecon (cough & cold), Luftal (anti-flatulence), Dermodex (for nappy rash), Tempra (adult

and paediatric pain relief), Picot

(antacids) and Graneodin-B (sore throat). Under this collaboration, RB will license the brands from BMS, who will continue to manufacture them for three years.

National symposium on pharmacovigilance organised by IPS

Reckitt Benckiser and BMS collaborate for

OTC medicines

Kapoor

Bancroft

Dr Diwan addressing the delegates

7News, Views & Analysis

Aanjaneya Lifecare receives ‘Golden Peacock National Quality Award’

Mumbai-based Aanjaneya Lifecare Ltd has received another feather in its cap – Golden Peacock National Quality Award – 2012 by winning the coveted title in Bengaluru on February 8, 2013.

Aanjaneya Lifecare Ltd has been selected as the winner of the ‘Golden Peacock National Quality Award’ on account of its formidable growth momentum under tough business environment for the year 2012 by the Awards Jury under the Chairmanship of Justice P N Bhagwati, Former Chief Justice of India and Member, UN Human Rights Commission; Justice M N Venkatachaliah, Chairman, IOD Advisory Council & Former Chief Justice of India were among the judging

panel for this year’s Golden Peacock Awards. The Award was conferred at a glittering award evening by Prof K V Thomas, Minister of State

for Consumer Affairs and Food & Public Distribution, Government of India

Speaking on the award, Dr Kannan Vishwanath,

Vice-Chairman & Managing Director, Aanjaneya Lifecare Ltd, said, “This coveted title of Golden Peacock National Quality Awards reflect the resounding success of Aanjaneya Lifecare in the pharmaceutical industry in a short span of time & meeting the tough global challenges of keeping the winning momentum. This award is a standing testimony of the entire Aanjaneya Lifecare’s internal & external stakeholders who have reposed faith in our organisation.” While we are elated to receive this rare distinction, our responsibility increases manifold as the road ahead is full of challenges & plethora o f o p p o r t u n i t i e s , Dr Vishwanath added.

In BriefLupin receives FDA approval for lorazepam oral concentrate USP, 2 mg/mL Lupin Ltd has announced that its subsidiary Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its lorazepam oral concentrate USP, 2 mg/mL from the US FDA to market a generic version of lorazepam intensol, 2 mg/mL, of Roxane Inc.

Lupin’s lorazepam oral concentrate USP, 2 mg/mL is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.

Lorazepam oral concentrate had annual US sales of approximately $ 10.7 million (IMS MAT Sept 2012 sales). Orchid posts net loss of ` 72 crore in Q3

Orchid Pharmaceuticals and Chemicals reported 33 per cent fall in its net revenue, widening its net loss to ` 72 crore in the third quarter of the current fiscal. The pharma company attained revenue worth ` 313 crore in the quarter compared to ` 470 crore in the corresponding quarter of the previous fiscal.

The company’s net loss increased from ` 10.12 crore in the third quarter of the last fiscal to ` 72.35 crore in the third quarter of this fiscal. The company underwent an exchange loss on FCCBs/FCTLs of ` 20.79 crore, during the quarter under review.

K Raghavendra Rao, CMD, Orchid Chemicals and Pharmaceuticals, stated, ‘’The overall performance of the company continues to witness pressure due to the tight working capital levels and debt leverage.’’

“We are working on completing the transfer of our penicillin and carbapenem business to Hospira and will see a significantly de-leveraged position from the deal proceeds leading to improved performance in the quarters to come,’’ Rao added.

Zydus Cadila gets USFDA nod for diabetes drugZydus Cadila has received US health regulator’s approval to market generic anti-diabetes drug pioglitazone HCL tablets in the American market.

The company has received US FDA’s approval to market pioglitazone HCL tablets in strengths of 15 mg, 30 mg and 45 mg, Zydus Cadila said in a filing to the BSE. As per the research firm IMS’s data, the estimated sales of pioglitazone HCL tablets in 2012 stood at $ 2 billion in the US market.

Dolutegravir received priority review by the US FDA for the treatment for HIV infection in combination with other antiretroviral agents, in adults and adolescents.

ViiV Healthcare, a global specialist HIV company established by GlaxoSmithKline (GSK), Pfizer and Shionogi, announced priority review designation by the US FDA for dolutegravir as a potential treatment for HIV infection in combination with other antiretroviral agents, in adults and adolescents. A priority review designation is granted to those drugs that have potential to offer significant improvement compared to currently marketed products

or provide a treatment where no adequate therapy exists.

“Dolutegravir is in development and subject to evaluation of the benefits and risks by the regulatory authorities before it can be approved and made available on prescription,” said the company in a statement. It is expected that this new drug, if approved, may challenge the world’s best-selling AIDS medicine, made by Gilead Sciences Inc. A regulatory decision is scheduled on August 17, 2013 after ViiV submitted the New Drug Application (NDA) in December 17, 2012. On the same day, applications were filed in the Europe and Canada.

US FDA grants priority review to new HIV drug

Dr VishwanathRao


Multisorb Technologies has appointed Laxmikant Khaitan to the position of Business Manager – Healthcare Packaging India as part of global expansion plan.

“Laxmikant Khaitan’s appointment is part of our continuing drive to provide leadership in the global healthcare packaging market,” said Adrian Possumato, Vice President - Healthcare Packaging, Multisorb. “His appointment reflects our dedication to offer the technical, quality, regulatory and service support that customers have come to expect from Multisorb.”

Based in Mumbai, India, Khaitan will report to Alan Xi, General Manager – Asia Pacific. Under Xi’s direction, Khaitan will provide technical sales and support to Multisorb’s growing customer base in India and will be working to implement

the Calculations through Operations®Program, Multisorb’s consultative business model, which is designed to provide customized active packaging solutions for drug product manufacturers and contract packagers.

“Laxmikant’s knowledge and skill set will contribute to the continued growth and success of Multisorb’s healthcare packaging

market in India,” said Xi. “Having a local presence is important to our continued growth in this region,” he added.

Khaitan has in-depth knowledge of Indian pharmaceutical sector and packaging, having worked for 14 years in various capacities with leading packaging companies such as MWV and Hindalco. In addition to his vast experience, Khaitan has earned a bachelor’s degree in biochemistry from St. Xavier’s College in Ahmedabad, and he holds an MBA with a marketing concentration from Gujarat University.

The appointment of Khaitan strengthens Multisorb’s technical sales capacity and allows it to get closer to existing and potential customers.Having a local presence demonstrates Multisorb’s commitment to offering excellent customer service and support.

Even in this modern world of smart phones, cars that park themselves, and nanotechnology, some things never seem to change. Liquid medicines or herbal solutions, for example, still taste bad, and avoiding their taste really has not progressed far beyond the ‘spoonful of sugar’ method. That may not be the case anymore, thanks to Tongue Cover, the first product to solve the problem of bitter medicines not by masking or diluting them, but by blocking the taste altogether.

“This is going to forever change the way we take medicine,” said Haris, the inventor, who spent a year planning and prototyping the Tongue Cover after completing MBA in International Business in Phoenix, AZ. The product acts as a latex protective barrier, forming a sheath over the tongue, thereby blocking and protecting the tongue from the bitter taste of liquid medicines, health drinks, herbal teas, vitamin solutions or pills. “Pharmaceutical companies have long focussed on sugar-coating pills or diluting liquid medicines to make them more bearable,” he added. ”But I envision the Tongue Cover to be the standard with every bottle of medicine in a couple of years from now, ” he said.

That vision has already found support in some scientific quarters. Former Advisor to WHO for Eastern Mediterranean Region, Dr Mohammad Waseem-ul-Islam, is a believer. “What motivates me to support this product is the scope of its potential social impact,” he said. “This could fundamentally change the way 7 billion people take medicine, and everybody falls sick at some point. This is not just a particular demographic segment of society we are talking about. This would be about everybody; this is for everybody.”

The patent-pending product is now available for pre-order on Indiegogo, the international crowd funding website. The site, similar to Kickstarter, is known to have funded some of the most creative and edgy inventions in the recent past. “I chose Indiegogo to raise funds over Kickstarter mainly because of its global audience appeal. And the Tongue Cover is truly a global product,” Haris added.

“We are ideally looking to raise $ 125,000 for our first production run to achieve true economies of scale,” he said.

Multisorb boosts global presence with appointment of Business Manager for Healthcare

Packaging Group in India

Tongue Cover introduces a new way to take the

bitterness out of medicine

Drugmaker Sanofi India, a unit of France’s Sanofi, has announced that it may consider launching sub-brands of its well-known brands such as Avil, Soframycin and Sea Cod in the future.

The firm has recently launched sub-brand Combiflam Plus in the market after launching pain relief cream Combiflam across India.

“This is the brand extension. We are first looking at our biggest brand Combiflam. This is the second time we extend the brand,” said Anindya Chowdhury, Senior Director (Consumer Healthcare), Sanofi India.

Chowdhury was in the city on the occasion of launching Combiflam Plus.

The new product marks the company’s foray into the OTC headache segment in the country.

“Sea Cod is a very important brand for us and it is in the market since a very long time,” Chowdhury said.

When asked whether the company would be looking to launch sub-brands of its popular other brands, he said, “We could look at that as brand extension is one part of the strategy.”

He said Sanofi was not looking at launching new brands very frequently.

The drugmaker said it was planning to double its market share in the country’s consumer healthcare business to 4.2 percent in the next three years.

Sanofi may launch sub-brands of its well-known products

Khaitan

Chowdhury


A delegation of pharmaceutical firms from Japan’s Toyama prefecture has indicated that Japanese companies are keen to collaborate with Indian pharma companies in trade and technology development. At a meeting organised by industry chamber FICCI, Yasuhiko Shioi, leader of the Japanese pharmaceutical delegation said that companies from Japan are keen to collaborate with Indian pharma companies.

“Indian and Japanese companies could also undertake joint market research and product development for world market as also jointly develop new technologies,” Shioi added.

Toyama, which is recognised as the cluster city of pharmaceutical industry in Japan, has around 100 companies. “We are looking for long term partnerships with Indian companies. There is immense scope of exporting Japanese products to Indian market and similarly Indian products can be traded in the Japanese market,” Shoichiro Hamano, President, Hamano International, said.

Speaking at the event, Daara Patel, Secretary General, Indian Drug Manufacturers’ Association (IDMA), said India is one of the world’s largest and most developed in pharma

sector. He also highlighted the availability of huge talent pool for sustaining and growing operations are making India an attractive choice for global pharma companies for investment, tie-ups, M&As.

India’s pharmaceutical sector is poised to grow from $ 21.7 billion currently to $ 36.7 billion by 2015. The Japanese market is estimated to be around $ 120 billion.

Bayer has submitted submitted application for approval of Riociguat® to treat patients with two forms of pulmonary

hypertension, for regulatory approval in the US and the Europe Union (EU). The drug is used to treat Chronic

Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), said Bayer.

Biocon has entered into an agreement with American generic drugmaker Mylan for developing and marketing generic versions of three high-value insulin products for developed and emerging markets.

The two companies will develop and market Glargine, the generic version of French drug maker Sanofi’s Lantus, Lispro and Humalog of Eli Lilly and Danish drugmaker Novo Nordisk’s NovoLog. Both companies will share development costs. Mylan estimates the global value of these drugs to be around $ 11.5 billion.

“We are excited to team up with Mylan to be able to cost effectively address

the disease and economic burden that diabetes poses to global health,” said Dr Kiran Mazumdar-Shaw, Managing Director, Biocon.

The agreement will give Mylan exclusive commercial rights in the US, Canada, Australia, New Zealand, the European Union and the European Free Trade Association countries through a profit sharing arrangement with Biocon, the companies said in a joint statement.

“This collaboration builds on our existing successful partnership for generic biologics with Biocon and brings Mylan a portfolio of high-value insulin analog products,” said Heather Bresch, Chief Executive, Mylan.

In 2009, Mylan and Biocon had come together to develop five blockbuster biologic drugs in cancer and pain areas.

Japanese pharma cos keen on tie-ups with Indian companies

Bayer submits application for approval of Riociguat® in US & EU

Biocon inks pact with Mylan for generic insulin

In BriefNatco Pharma net up 33 per cent at ` 22.59 crore Hyderabad-based Natco Pharma has reported a 32.88 per cent jump in net profit to ` 22.59 crore for the quarter ended December 2012.

The company posted ` 17 crore profit in the corresponding quarter previous year. Total income grew 31.92 per cent to ` 183.54 crore for the quarter as compared with ` 139.13 crore in the same quarter, a year ago. Sequentially, income from operations, however, marginally declined to ` 177.61 crore from ` 180.32 crore in the quarter ended September 2012. Expenditure grew 24.17 per cent.

Natco Pharma was incorporated in Hyderabad in the year 1981 with an initial investment of ` 3.3 million. With a modest beginning of operations as a single unit with 20 employees, NATCO today has five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in new drug development etc. Sanofi need not pay capital gain tax: Andhra HCIn what is seen as a major relief for France-based Sanofi Aventis, the Andhra Pradesh High Court said Sanofi Aventis need not pay capital gain tax as demanded by Income Tax (I-T) department for the acquisition of Shantha Biotech in 2009.Sanofi had stated that that the tax for the acquisition of Shantha Biotech was paid in France under French law as the actual deal saw Sanofi’s vaccine unit buying French firm ShanH, which held 80 per cent stake in the Indian company. It may be recalled that the I-T department sought capital gain tax from Sanofi, claiming that it gained new market and platform for its products through acquisition of Shantha Biotech, which Sanofi had challenged in 2010.

Dr Mazumdar-Shaw


US FDA has requested additional data from a trial focused on cardiovascular effects before it would consider approving

Tresiba® and related product Ryzodeg®. The setback for Tresiba®, also known as degludec, is good news for rival makers of insulin medicines, notably France’s Sanofi, whose Lantus product is threatened by Novo’s newer ultra-long-lasting treatment. Most investors had expected a green

light from the drug regulators, following a positive recommendation from an advisory panel to the FDA last November, despite earlier signals that there might be heart issues with the medicine. Optimism about Tresiba® and Ryzodeg® - which combines degludec with another formulation of insulin - was further boosted by approval in Europe, where both drugs has received a go-signal last month. They have also been approved in Japan.

Drug firm Abbott India posted 34.95 per cent rise in net profit at ` 49.77 crore for the fourth quarter ended December 31, 2012.

The company had posted net profit of ` 36.88 crore in the same period of 2011, Abbott said in a filing to the BSE.Net sales of the company rose to ` 437.52 crore in the fourth quarter, compared to ` 383.60 crore in the same period of 2011.Abbott India, today has strong brand equity and commands esteem in the market place. To reach the customer, Abbott India has a network of 18 distribution points, which cater to 11,000 stockists and 70,000 retailers.

Novo Nordisk’s new long-acting insulin Tresiba® receives major

blow from US FDA

Abbott India net up 35 per cent at ` 50 crore in Q4

A pioneering drug development team at the University of Aberdeen has received a £ 1.5 million funding boost to accelerate the progress of multiple novel drug leads to tackle cancer and diseases such as debilitating inflammatory conditions.

Scottish Enterprise and Biotechnology and Biological Sciences Research Council have provided financial support for the innovative work which takes to the next level research first developed at the University a decade ago, which created novel therapies based on the immune system of one of the most ancient species on the planet - sharks.

The next-generation technologies now being developed - which will be spun out of the University into a company later this year - uses

small man-made proteins closely related to structures called Variable Novel Antigen Receptors (VNARS), found in the shark immune system. VNARs are the smallest molecule of this type identified so far in the animal kingdom.

The VNARs engineered by the team in the lab are the same size, and are being used to develop new drugs as well

as to deliver - in a more tailored way - drugs into the body. Their small size will

provide better penetration of solid cancer tumours and also make them capable of crossing into the brain. Their size, and less complicated structure, also potentially makes them much cheaper medicines than other related therapies.

The team, comprising ex-industry professionals

and leading academics, have successfully produced over 10 billion of these drug-like molecules. They say their VNAR drug library is the ‘equivalent to having access to 10,000 sharks without needing to keep a single animal in an aquarium’. From this drug library they have already successfully gone ‘fishing’ for new therapies to conditions such as cancer or inflammation.

One of the team’s VNARs can significantly extend the effective life of existing and new drugs in the body.

Typically drugs have to be taken every few hours. However, if joined to the new VNAR, their useful potency can be increased from hours to weeks. Other VNARs can specifically recognise, target and then destroy cancer cells. By the end of this funding period the Aberdeen team aim to have produced drug candidates that not only have a long half-life but can also seek out and deliver

deep into tumours powerful toxins that are tailor-made to kill cancer cells.

The University’s Professor Andy Porter and Dr Caroline Barelle are heading the research. They have already had success with the drug discovery company Haptogen Ltd - a University of Aberdeen spin-out that was bought by the US pharmaceutical company Wyeth Inc in 2007.

Professor Porter, Professor of Biotechnology and Director of the Scottish Biologics Facility, said, “We are excited and delighted with the support we have received from Scottish Enterprise and BBSRC for our research. These next-generation, targeted therapies show the potential to be more effective than current approaches, with less side-effects for patients and reduced costs of drug manufacture.”

Dr Barelle, Senior Research Fellow, added, “We have already received commercial interest in

our progress to date and I hope to use my industry background to help turn our exciting drug leads into a new successful biotechnology company which we will spin-out from the University of Aberdeen.”

Professor Stephen Logan, Senior Vice-Principal, University of Aberdeen, said, “This is ambitious and exciting research which will help build on Aberdeen’s reputation as Scotland’s commercial capital for drug discovery.”

Julia Brown, Director - Foresighting, Scottish Enterprise added, “Scottish Enterprise recognises the international strength of the biologics research and commercialisation capabilities of the University of Aberdeen and is pleased to be able to support this innovative project. The technology involved has huge potential and the challenge now is to help translate this into a successful company, located in Scotland.”

Pioneering drug discovery gets major funding to move to next stage

12 In Conversation With

Going forward, production of generics shall be more popular in Japan as well as other western countries

Manas R [email protected]

Recognised as Japan’s most commercialised region, Osaka functions as the command centre

for the Japanese economy. Osaka has a long history spanning over the last 4 centuries of having its integrated business in pharmaceutical domain and continues to be the town of medicine. Kansai, the central region of Osaka, holds Japan’s largest share in the pharmaceutical industry and also the second largest share in medical equipment.

Recently, Matsui was in Mumbai with the Osaka Prefectural Government and pharmaceutical & medical equipment sector business delegation to interact with the captains of the Indian industry. This event was organised by the Confederation of Indian Industry and the Consulate General of Japan.

What are the key objectives of this business delegation of Osaka Prefectural Government and pharmaceutical and medical equipment sector from Japan? In terms of Osaka Prefectural Government’s policy, the main objective of this business delegation is to support the Osaka-based companies to expand their business overseas. The other objective, for which especially I am visiting India, is to promote Osaka’s highly advanced pharmaceutical & medical equipment industry in India and thereby attract Indian companies to expand their business in Osaka.

What are the other highlights of this business delegation? Osaka has clusters of manufacturers of pharmaceutical products and medical equipment.

In terms of production of pharmaceutical products Osaka has the No. 1 share in Japan and for medical equipment, it ranks No. 2. This delegation comprises the Osaka companies representing these clusters.

The delegation’s business needs in India is, among other aspects, to procure pharmaceutical intermediates from Indian companies and to sell the pharmaceutical products to Indian companies or local hospitals.

What is the current trade flow between India and Japan in the pharmaceutical sector?I have heard that the export of pharmaceutical products from India to foreign countries was approximately $ 9 billion in 2008, about 1 per cent of which went to the Japanese market. The export of pharmaceutical products from Japan to foreign countries was approximately $ 40 billion in 2008, while import from foreign countries was approximately $ 150 billion in 2009.

The number of Indian companies which have tried to sell their generics to the Japanese market has been increasing of late. The examples include Lupin’s tie up with Japanese pharmaceutical makers as well as establishment of Japanese subsidiaries by Zydus Cadila and Torrent Pharmaceuticals.

The activity of Japanese companies expanding their business in India has also been increased. One example is Daiichi Sankyo, which has merged with Ranbaxy Laboratories in order to expand its business in India.

What are the business opportunities between India and Japan in the pharmaceutical sector? While Japan is a potential market for generics, India is one of the most advanced markets for

generics. If the Osaka companies can work together with Indian companies on producing or researching generics, among others, this would generate high business opportunities in both India and Japan.

Which areas in the pharmaceutical sector should see more action in terms of collaboration between India and Japan? One of the potential areas is generics, as mentioned above. The other is medical equipment with highly advanced technology developed in Osaka, which should see greater action between Indian hospitals and the Osaka-based manufacturers.

What are the trade policy-related challenges affecting the growth of business between India and Japan in the pharmaceutical sector? At present, there are too strict regulations for generics or approval of other drugs etc. However, we are trying to encourage the national government to ease the regulations.

Also, high corporate taxes imposed on foreign investment into Japan might hinder the growth of pharmaceutical business between India and Japan. In this context, Osaka is trying to address it positively by creating Special Economic Zone (SEZ) where no local tax should be levied on foreign investment for five years since the beginning of business.

What promising trends do you observe in the Indian pharmaceutical sector and what is the outlook for its near- to mid-term future? Generics is one of the promising trends in India. Going forward, production of generics shall be more popular in Japan as well as other western countries

in order to control the cost of health insurance covered by the government.

What is the business etiquette that you value the most?I believe in mutual trust, fulfilling the engagement and integrity.

Your message for aspiring entrepreneurs in the pharmaceutical sector… The collaboration between Indian and Japanese

pharmaceutical companies will strengthen more mutual development.

The three check points you refer to before taking any policy decision… Check if the policy should be made for public interest of Osaka and Japan. Also, check the balance of the interest between parties. At the same time it is important to know if I will enjoy fulfilling the responsibilities.

…says Ichiro Matsui, Governor of Osaka, Japan. In this free-wheeling conversation, he shares insights on the exclusive visit to India, from promoting business opportunities present in pharmaceutical & medical equipment sector to strengthening economic ties between India and Japan. Edited excerpts…

13Special Focus

The pharmaceutical sector is among the major industries in India, which is expected

to become one of the most advanced nations globally in terms of the growth of the healthcare segment and newer developments in pharmaceutical equipment and manufacturing of bulk pharmaceutical drugs.

Speaking on the industrial facts, Dr Raghunandan H V, Associate Professor and Coordinator – Industry Institute Interaction, JSS University, Mysore, says, “India is one of the largest manufacturers of the pharmaceutical dosage forms. Small and medium scale entrepreneurs play a vital role in the manufacture of the drug products. In fact, SMEs account for around 87 per cent in production by volume and 40 per cent by value in the pharma industry. India is the world’s fourth-largest producer of pharmaceuticals by volume, accounting for around 8 to 10 per cent of the total global production. Due to the increase in consumption and strong export market, the Indian pharmaceutical industry has been witnessing phenomenal growth in recent years. The industry has seen tremendous progress in terms of infrastructure development, technology and the wide range of products manufactured. Indian players have proved their ability to produce cost-effective drugs with their state-of-the-art manufacturing facilities, thus increasing exports from the country.”

Current scenario According to a study by Pharmexcil, the export of pharmaceutical, drugs and fine chemicals grew by 27 per cent reaching ` 60,000 crore. The Gujarat-based manufacturers are targeting export markets, particularly to growing economies including African and Latin American (LatAm) countries. Government of India is also planning to promote country’s generic export under the ‘Pharma India’ brand campaign over the next three years period.

The pharma SMEs in the state of Gujarat are exclusively targeting export markets, specifically on emerging economies comprising of African and LatAm nations. These SMEs have already posted pharma products export

of ` 400- 500 crore during 2011-12. Emerging markets account for 50-60 per cent of overall pharma SMEs export from Gujarat, which continue to grow at an annual rate of 30-35 per cent, according to IDMA data.

T h e p r o p o s e d recommendation by the Commerce Ministry, for doubling export in 2013-2014 includes:

Strategic targets for exports in pharma drug and fine chemical consists of increasing from around $ 10.32 billion in 2010-2011 to $ 15 billion in 2013-2014, accounting 5 per cent share in countries total export.

On the basis of domestic production capabilities and potential demand, pharmaceuticals, drugs and chemicals export would need to increase considerable to realise the overall growth objectives and these segments would be prioritised accordingly

From R&D and technological perspective, pharmaceutical sector is thriving in the formulations segment and extending the generics base as more medicines are going off patent

India would have to focus on emerging markets in Asia, Africa and LatAm countries apart from setting up new beachheads and strengthening its footprint in newly opened markets

EXIM policyThe EXIM policy covers different industrial aspects and devised with a views to

support the interest of the pharmaceutical equipment and drugs producers and the Government of India. The government is further exercising to focus on various options under EXIM policy to ensure the growth of nations thriving pharmaceutical sector as well as check increasing takeovers by the

foreign companies. EXIM policy regulates the

export and import of drugs and pharmaceuticals in India, which is recognised and a major global player in the field of pharmaceuticals. European nations account for maximum share of Indian pharmaceutical exports followed by North America and Asia. The pharma EXIM policy proposals in the recent past brought qualitative and quantitative developments in the R&D activities of this sector.

Under the new export policy pharmaceutical sector is granted various sanctions such as:

Export Obligation Period (EOP) has been extended from 6 months to 36 months for advance authorisations for pharmaceutical products

Domestic drug exporters will hugely benefit from the extension of export obligation period. This will encourage exporters to import raw materials and enjoy tax benefits for a period of three years for exporting finished goods

Pharmaceuticals have also been part of Market Linked Focus Product Scheme (MLFPS), which will introduce exporters to 13 different markets such as Australia, New Zealand, Brazil, Nigeria and Kenya. This inclusion of this scheme will give a significant boost to pharmaceutical exports

With an ambitious plan by the Government of India to increase the overall export, two measures are

floated including the Duty Entitlement Passbook and Export Promotion Capital Goods Scheme in addition to launching stimulus packages. The new export policy revolves around expansion of country’s export in emerging economies such as LatAm, Commonwealth of Independent States (CIS) and African nations. Additionally, these schemes will remain in practice for next two years

Foreign Trade Policy The foreign trade policy 2009-14 offers various benefits to the exporters, which include:

Pharmaceuticals has been included in Market Linked Focus Product Scheme (MLFPS), and the associated benefits from the scheme will be offered, if export destinations are the 13 markets comprising of Cambodia, Algeria, Egypt, Kenya, South Africa, Nigeria, Tanzania, Mexico, Brazil, Ukraine, Vietnam, Australia and New Zealand

Under Market Development Assess (MDA) government is offering financial support for an array of export promotional activities endorsed by EPC & Trade Promotion organisation

In addition, incentives are offered for travelling abroad to promote export in LatAm, African and CIS nations. Thus, several benefits as

mentioned are being offered on exporting, and all companies should look forward to tap them.

Tapping the regulatory benefits The Indian pharma sector, the generics capital of the world, is witnessing some new measures from the regulatory agencies and planning commissions. In order to penetrate new markets and increase the export of drugs, the government is offering several benefits on exports to emerging economies such as CIS, African and LatAm countries with valuable inputs and recommendation from Pharmexcil and Commerce ministry.

Exporting to CIS, African and LatAm countries

The industry has seen tremendous progress in terms of infrastructure

development, technology and the

wide range of products manufactured. Indian

players have proved their ability to produce

cost-effective drugs with their state-of-the-art

manufacturing facilities, thus increasing exports

from the country.

Dr Raghunandan H VAssociate Professor and Coordinator – Industry

Institute Interaction, JSS University, Mysore

Nikunj [email protected]

PrivateEquity

14 Special Focus

India is now considered as the third largest m a nu f a c t u re r o f pharmaceuticals. These

products are exported to more than 250 countries worldwide including the highly regulated markets of USA, Europe, Japan and Australia. According to a McKinsey report, the industry has been consistently growing at 13 to 14 per cent over the past few years. Small and Medium Enterprises (SMEs) are considered the nucleus of creating new business in any flourishing economy. In India, besides giant MNCs, SMEs essentially offers potential for economic development. They contribute to around 40 per cent by value. The Indian pharma SMEs are chiefly fragmented and heterogeneous sectors, with firms having varied levels of technological capability. As defined by Micro, Small and Medium Enterprises Development Act, 2006, enterprises are divided into small, medium, large units on the basis of investment made in the facilities. Although the SME pharma has huge market and has tremendous potential it is yet to be tapped to its fully.

Structure of the SMEs is an important feature of industrial India. Since 2005, for SMEs to adopt government tenders, are required to have a Good Manufacturing Practice (GMP) certificate. Although government offers some helping hand, Indian pharma SMEs have to improve their competitive strength on their own. All such changes have led to new challenges for the SMEs on improving quality of manufacturing practices like upgrading the manufacturing facilities, product and innovation strategies to survive in the domestic and global market.

Key infrastructural challengesTo fuel innovation and sustain growth, SMEs requires

adequate funding and steady investments. “SMEs are often constrained by management

inefficiencies, lack of technological assets such as instruments and equipment, errant facilities and having limited human resources. Besides this, a key constraint to infrastructure is the financial support,” avers Anand Shah, MD & CEO, Enaltec Labs. Sophisticated instruments and equipment also has a vital role in generating important data related to the drug during scale-

up and commercialisation. These types of tools are available with major private institutions and pharma giants, the access to such sophistication is not available with all pharma SMEs. “Though a very few private laboratories running it, but it becomes commercially unviable for SMEs in a development activity where a huge number of process and experiments needs the sophistication,” states Shah.

Although, many Indian SMEs are not into advanced drug research and testing, still, they need technology to improve efficiency in quality assurance and control, and for adherence to regulatory requirements for operation and testing, improving batch tracking and expiry date tracking, optimising credit and logistics control and optimally tracking consignment sales. “Due to constraints such as budgets and limited infrastructure, they are often reluctant in adopting latest technology,” adds Shah.

Restricted access to resources also proves to be an impediment to their endeavour to move up the value chain, as it is compelling SMEs to put R&D and innovations on the back burner. “Keeping a dedicated scientific team is a big challenge for any SME,” affirms Dr V N Balaji, Independent R&D Consultant.

Breaking the vicious cycleFor SMEs, the financing pattern is radically different from other larger companies. On an average, they get only 15 per cent from internal sources, indicating that they are far less profitable, 25 per cent from banks and financial institutions and 10 percent from capital markets. As much as 50 per cent of their total annual funding comes from alternative sources of which friends and family equity account for a huge proportion followed by trade credit.

“Financing is also available from banks for working capital and funding expenditure. For example, institutions such as EXIM and SIDBI have recently introduced financial assistance programmes in the form of long-term debt for developing innovative technology products, where

they fund both capital and revenue expenditure. SIDBI also has a scheme wherein they can step in with seed capital. Few nationalised banks have schemes where they fund their existing clients for R&D initiatives,” suggests Shah.

Government initiativesThe Ministry of MSME has instituted a significant step to enable small and medium companies to meet new technological and regulatory challenges by formulating a National Manufacturing Competitiveness Programme (NMCP). Under this programme, a ‘major promotional package’ has been announced to provide support to the SMEs in the areas of credit, technological upgradation and marketing.Government of India has

taken several proactive steps to ensure that healthcare is easily accessible in the country. These steps include boosting the manufacturing and research and development capabilities of the SMEs in the life sciences segment.

Financial assistance programmes such as the Credit Linked Capital Subsidy Scheme (CLCSS) for technology upgrade of small-scale industries, have been introduced to enable SMEs to comply with Good Manufacturing Practices (GMP) standards with the revised Schedule M norms under the Drugs and Cosmetics Act. “The government now allows a tax deduction of 200 per cent on expenditure on scientific research (excluding cost of any land or building) on in-house research and development facility u/s 35(2AB) of the Income Tax Act. This makes in-house R&D an attractive proposition,” advises Shah.

The government has also announced a Pharmaceutical Technology Up- gradation Assistance Scheme (PTUAS) that provides a 5 per cent interest subsidy for SMEs to upgrade their

facilities to comply with WHO-GMP standards. Complying with these standards will help companies export their products to a large number of countries.

D e p a r t m e n t o f Biotechnology provides subsidy on borrowings to SMEs to building necessary infrastructure for standardisation of their products and promote the development of pharmaceutical SEZs which facilitates the availability of infrastructure, market access, boosts capacity utilisation, encourages exports and facilitates excise relief.

“A well financed SME can perhaps look at an overseas acquisition as a strategy to overcome their limits in innovation strength by accessing new products and their technologies, skills and new markets,” believes Shah.

Need to strengthen the baseTechnological obsolescence, limited finance, paucity of skilled resources, and stringent regulatory requirements are some of the known challenges confronting Indian pharma SMEs. Here, we closely examine these infrastructural deficiencies and explore plausible opportunities...

Infrastructural challenges and opportunities

Dr V N BalajiIndependent R&D Consultant

The government now allows a tax

deduction of 200 per cent on expenditure on scientific research on

in-house R&D facility.

Anand ShahMD & CEO, Enaltec Labs

Keeping a dedicated scientific

team is a big challenge for any

SMEs.

Hardik [email protected]

Governmentinventives

PrivateEquity

VentureCapital and

AngelFunding

Banking preferences of pharmaceutical SMEs

0 20 40 60 80 100

% of respondents

Others

Co-operative

MNC

Private sector

Public sector

Finance

Facilitycertification

MajorChallenges ResourcesTechnology

Financial options available for pharma SMEs

Banking preferences of pharmaceutical SMEs (Source: Report on Emerging Pharmaceutical SMEs in India. Dun & Bradstreet, 2007)

Major limitations & challenges faced by Indian pharma SMEs

15Special Focus: Interface

What are the new opportunities for pharma SMEs?Today, pharma SMEs are witnessing immense growth opportunities. They are receiving outsourcing contracts from all areas including R&D, production and for conducting clinical trials. India has become an outsourcing hub, which in turn is propelling the growth of the entire industry. The industry is growing steadily at around 14 per cent per year. Also, the healthcare budgets are on an incline. The industry is adapting to concentrating on a specific product line which in turn is streamlining operations and giving better returns.

How has production and trade grown for SMEs in the last 10 years?According to the Confederation of Indian Industries (CII), there are around 8,000 SME units, accounting for about 70 per cent of the total number of the pharma units in India. The Indian pharmaceutical industry has witnessed a robust growth of around 14 per cent since the beginning of the 11th Five Year Plan in 2007. Today, SMEs account for around 87 per cent in production by volume and 40 per cent by value in the pharma industry. They contribute to 35 per

cent sales of the pharma sector and generate a turnover of around Rs 35,000 crore. However, as of now regulations in India have become stricter and smaller countries are also enforcing stringent regulations. In spite of this, there has been a steady growth in all functional areas. The year 2012 saw 25 per cent more outsourcing contracts than that in 2011.

What are the infrastructural challenges SMEs face today?The cost of land is very high and setting up new plants becomes a challenge and return on investment takes more than 4-5 years. Another challenge SMEs face is the fact that corporate approvals take 2-3 years and the waiting period becomes an issue. As the approvals have become more stringent, it is sensible to build infrastructure in sections instead of setting up the entire plant at one go. Plants dedicated to one speciality works well in such settings.

Is there an increasing orientation towards R&D among SMEs today?SMEs still lag behind when in comes to full-fledged R&D. R&D still remains the domain of large companies. R&D in SMEs is mostly carried out in small and specific areas. However, outsourced research contracts from US and Europe are on the rise. SMEs are fully aware of the importance and need for research and innovation but lack funding. In the US, small

venture capitals and the government spend large amounts on research funding.

How can the government aid in bringing about further growth of the pharma SME sector?The Indian Government has been in talks with the industry about creating more research funds. The government has also proposed various ideas at conventions and conferences and has a strong intention towards promoting research in the country. India has huge growth opportunities and is home to brilliant scientists. However, a collaborative effort between the government research organisations

and the industry bodies is still lacking. Although the government has poured in a lot of money in setting up research institutes, translating it into productive returns for the industry is yet to be seen. This has been a reason of frustration for the industry. India should take cue from the US and start making joint efforts to further strengthen this sector.

Are SMEs today fully exploiting their export potential? What more can be done?India is faring well in the export segment. Pharma Export Promotion Council (Pharmexcil) has played a pivotal role in ramping up exports from the country. They are actively conducting tours to several countries and taking delegations for international trade shows. The key markets Pharmexcil is concentrating on are Russia, Ukraine, Brazil, Japan, Spain Greece, Germany etc. SME trade from India has significantly improved in the last 10 years. As per reports, SMEs based in Gujarat exported pharma products worth Rs 400-Rs 500 crore ($ 74.63- $ 93.28 million) in 2011-12. Of the net exports by SMEs, the share of emerging markets is 50-60 per cent, and it is rising yearly by 30-35 per cent.

The government and the industry should work collaboratively in order to strengthen R&D in pharma

…says T S Jaishankar, Managing Director, Quest Life Sciences Pvt Ltd, and Chairman, Confederation of Indian Pharmaceutical Industry (SSI) (CIPI). Here, he also speaks about the Small And Medium Enterprise (SME) of pharma industry in India.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

16

Enaltec Labs is a fast emerging Active Pharmaceutical Ingredients (API) manufacturer & supplier in India set up by

a group of young professionals with the specific objective of providing the critical India advantage to generic formulators across the world. Enaltec Labs was established in 2006 by a group of young and experienced professionals to develop and produce complex, small volume, technology-driven products at competitive prices, thus providing India a critical advantage.

Initial yearsThe paradigm shift of leading Indian pharma companies to target high volume and blockbuster products for regulated markets has been the inspiration behind the launch of Enaltec Labs. The vision of Enaltec Labs is to be a partner of global healthcare industry for supplying high quality APIs at competitive prices complying with stringent regulatory requirements. Enaltec Labs is one of the few independent Indian API suppliers with world-class infrastructure, having no intention of competing with its customers in their home market. Elaborating on the vision of the company, Anand Shah, MD & CEO, Enaltec Labs, says, “The constant vision and mission for Enaltec Labs was to be a partner of global healthcare industry for supplying high quality pharma products at competitive prices complying with stringent regulatory requirements.” Discussing the idea that enthused to form the company, Susheel Koul, Director, Enaltec Labs, says, “The idea of Enaltec Labs stemmed from the fact that there was dearth of a company for pure API. And then onwards it was a long journey. Today, the turnover of the company for financial year 2011 – 12 is ` 68 crore. Further, export forms 80 per cent of the entire business.” Recollecting the earlier days Koul adds, “Funding and forming the required talent were the primary challenges” He highlights, “Right now we are working with the products that are going off patent in 2016-2020.”

Strengthening the R&D armThe R&D lab is fully equipped with the latest fume hood systems with a variety of equipment ranging from lab hydrogenators to ozonisers. The strength is the scientific pool and experience of the team having wide chemistry capabilities. This is backed with a fully equipped analytical laboratory with the entire

range of analytical equipment from High-Performance Liquid Chromatography (HPLC) to Gas Chromatography (GC) systems. The quality systems conform to national and international regulations and

have been implemented across all our operations to ensure qualitative output at each step. Further, it is also affiliated with various renowned universities and institutes in India such as NCL Pune, Central University Hyderabad, IICT and other universities around Mumbai, which increases the reach in understanding and developing more complex chemistry products. In other words, the lab is ultimately committed to timely delivery of all the services within the quality parameters set by the customers. Talking about the importance of research, Dr B V Sivakumar, Chief Scientific Officer, Enaltec Labs, says, “Research is the crux for any industry. One should be in touch with the latest innovative processes to upgrade oneself for the needs of tomorrow. We believe in the strength of R&D.” As far as the talent pool is concerned, Dr Sivakumar

avers that majority of people working in Enaltec Labs has completed their MSc in Chemistry. He emphasises, “I have ensured that the lab atmosphere is extremely transparent, thus making it extremely encouraging.”

Manufacturing plantsEnaltec Labs has two multipurpose small to large volume plants with volumes ranging from 50 to 4000 litres capacity. The first plant is complying for US & EU regulatory requirements and another is focussing on the requirements of other markets complying to GMP guidelines.

The multipurpose plant at Ambarnath, Thane is dedicated to the regulated market. This plant is spread over an area of 60,000 sq ft, which includes administrative block, production block, quality control, quality assurance, warehouse and utilities. It is best suited for manufacturing two products simultaneously in capacity of gms levels to few hundred kg level (per month) for APIs and advanced intermediates. A fully qualified HVAC system including full control of temperature, humidity and room pressure ensures the right environment for quality manufacturing. The second plant meant for the semi-regulated products is located at Nashik. This plant spread over 1,35,000 sq ft occupies 40,000 sq ft constructed area that includes administrative block, production block, quality control, quality assurance, warehouse and utilities.

Quality and regulatory systemsThe requisite quality systems conforming to national and international regulations have been implemented across all the operations to ensure qualitative output at each step. One of the salient features of the quality systems is strategic planning and management review that includes emphasis on quality management systems, periodic review of quality systems and review of the progress towards achieving quality objectives. Enaltec Labs also possesses a well-defined regulatory affairs structure managed by highly qualified and experienced experts in this field.

Further, all documents being generated are highly controlled and archived according to the international standards. Additionally, the implementation of corrective and preventive actions concluded from an investigation, are closely monitored by the quality assurance team. The well-defined process controls and documentation procedures are the key to achieve quality documentation and to ensure qualitative output meeting all the pre determined specifications consistently.

Achievement scaleEnaltec Labs have clocked in more than 100 per cent year-on-year growth from inception making it one of the fastest growing API companies in India. Apart from financials, the company has tremendous progress in improving ourselves.

Elaborating on the markets that the company covers, Koul says, “Earlier we started with Asia Pacific but at the moment we are everywhere. Today, we export to 30 countries and our turnover was ` 700 million last year.” Talking about the company’s competitors he adds, “We do not consider anyone as our competitor. In the field of API we cannot say that we are the only company that makes this product because every company manufactures 50-70 products.”

Setting it apartExperienced R&D team, well qualified & equipped to develop most complex APIs and expertise to handle wide range of chemical reactions are few of the factors that set him apart. The company claims for the strong intellectual property management and regulatory back up. Talking about the USP of the company, Shah says, “The USP of the company is being a neutral API supplier and small volumes APIs meeting US & EU regulatory standards.” Koul adds, “The company still believes that the primary strength of the company is in its R&D. We have been investing 8 per cent of the revenue in R&D.” He concludes, “In the next 10 years we can see Enaltec as one of the major players.”

Facility Visit

Funding and forming the required talent were the

primary challenges. Right now we are working with

the products that are going off patent in 2016-2020.

Susheel Koul Director

Chandreyee [email protected]

Enaltec LabsTreading the treacherous research path successfully

Analytical lab at the premises

With research as the primary strength, Enaltec Labs is one of the few independent Indian API suppliers with top class infrastructure. Read on to find more about its exciting journey and what makes the company different from the rest.

18 Insight & Outlook: Roundtable

products

Regulation has proven to be a time-consuming process time and again. But compliance to required approvals and adhering to regulations cannot be avoided just with the excuse of time. There should be a fine balance between the two. Nanotechnology products, though helpful in many ways, should be used with regulated care.

Editorial take

Dr Amita BirlaAssociate Director-Clinical Operations, Karmic Lifesciences

Dr Ranjeet S AjmaniCEO, Plasmagen Biosciences Pvt Ltd

Vikram GuptaFounder and Managing Partner, IvyCap Ventures Advisors Pvt Ltd

Nanoparticles are designed in a way that they get attracted to diseased cells, which facilitates the direct treatment of those cells and reduces the damage to healthy surrounding cells. These also help for earlier detection of disease. Since this technology is quite intricate and sensitive in the sense of its science and has direct bearing on the safety and health of the patients, it would be pertinent to regulate it, so that it yields desired results. It would also be relevant to mention that the various particles that are used in the process are made from various chemicals, biochemical, metals etc and one does not know how these particles may behave in living system, and especially in the disease state. Indiscriminate use of any technology especially in the clinical situation may have its own concerns. Also, all over the world the various clinical trials using nanotechnology-based products are on and we need to wait and critically/objectively understand its impact. Since this technology is evolved and developed by interdisciplinary teams; chemistry, physics, material science, engineering, clinical sciences etc, it is important to make sure its validity in the sense of its products for human use, are properly regulated and monitored.

Pertaining to this topic there are several debates. Nanotech products are needed to be regulated keeping in mind that the benefits of these products are to be availed by the huge mass. The situation is very similar to that of clinical trials. Unfortunately, the government is not aware how the process works and India is still not enough

mature to handle this. Regulation indicates that this is a time-consuming

matter because approval process takes considerable time. However, with this excuse regulations should not be

avoided. With regulation, Indian market will be able to handle hazards to some extent. Thus, it is better to complete the regulation process of nanotech products in phases.

As regards to this issue, developed countries such as the US is also facing similar problems. We must understand that nanotechnology is relatively a new aspect with new potential hazards. However, since the US has better regulation structure it can handle better and we as Indians hopefully should follow the footsteps. Nanotechnology products have several benefits and that can be utilised through better regulation. Therefore, one must remember that one of the most crucial aspects of the regulation concerning nanotechnology products is compliance with the safety features.

There are numerous nanotech applications that are either currently in the market in India or are planned to be marketed over the coming years. The most dominant sectors by far are healthcare and textiles. In the healthcare sector, current applications include various cancer treatment drugs, medical devices and gene therapy. Nanotechnology involves manipulation of materials on an atomic or molecular scale. Thus, though some may believe that nanomaterials are just scaled-down versions of bulk chemicals, or that nanomaterials should not be regulated, but it is important to understand that new toxicological risks may be derived from the new materials and/or new conformations of existing materials. Thus, as the industry grows in India, regulating this sector at appropriate time and working on modifying the policies as required will help us address the issues on safety, effectiveness or public health impact of these products. These guidelines must have general consideration for nanotechnology products such as characterisation, safety and environmental impact. Characterisation must consider forms in which particles are presented, eg liposomes, nanoparticles; validated assays to detect and quantify nanoparticles; long and short term stability of nano materials (in various environments); physical characteristic impact on product quality and performance; critical steps in manufacturing process. Though the existing battery of preclinical tests is currently believed to be adequate, we may need to modify the same need based to cover all the above considerations.

Every drug and even medical device need to be regulated and nanotechnology products are not any exception. However, for these products regulations have not been standardised either by WHO or any other regulatory body. Further, we must consider that there

are not too many nanotechnology products and the primary reason is the prohibitive cost. However, in spite of this aspect, the need of the hour is to

standardise or regulate nanotechnology products. With nanotechnology, the composition of the

products changes and therefore this necessitates the need of standardisation. Thus, the problem is significant and deserves special mention. It is for the government regulatory authorities to consider the issue and consider it seriously. The Indian Government should consider this as a serious concern and consider nanotech products

as new products. Considering the situations in other countries - while in the US, bioequivalent

study is required, in Europe, chemical endpoint trial is mandatory, India should follow the footsteps.

Looking forward in the next 5 years, it is extremely important for the government to consider nanotech products important. But it must be remembered that unless there is a blockbuster there is no real achievement.

T S JaishankarFounder Chairman, CIPI and Managing Director, Quest Life Sciences Pvt Ltd

Safety consideration while

using nanotechnology must analyse size-specific effects on

Absorption, Distribution, Metabolism, and Excretion (ADME) and route-

specific effect. Environmental effect must consider release of nano particle into the environment following human and animal

use. Considering the above factors, regulating nanotechnology products

is a primary requirement. But do the experts agree?

Chandreyee [email protected]

Should nanotechnology

be regulated?

19Insight & Outlook: Interface

What kinds of methods are used to perform extractables and leachable studies? Extractable studies are conducted to understand what substances are contained in a material that has the potential to leach into the drug product. The chemical composition of surfaces that come in contact with the drug product, the solubilising power of the drug product, the duration and conditions of contact are all relevant considerations. This testing is performed under exaggerated conditions of time and temperature in the laboratory using common solvents that bracket the solvating power of the drug. Then, the therapeutic indication dosage form, route of entry into the body and frequency as well as the life expectancy of the patient help establish an acceptable level of risk to be argued on a scientific basis. Trustworthy identification and sensitive logical techniques are essential.

A leachable study is conducted in order to monitor any substances that leach out of a material into the final drug product in its commercial packaging (primary and secondary) and are thus exposed to patients. The smart way to conduct a regulatory leachable study is as part of a regulatory stability study where the substances of concern and to be controlled will are identified via toxicological consideration of the extractables data.

How do pharma companies benefit from extractable and leachable studies?With the increase in generics and contract manufacturing activities in countries such as India and China, it is imperative to have strong local expertise to look into quality at all levels, including medical devices.

Are there any ‘good practices’ involved in extractables and leachables?It is ideal to understand the details of the packaging system and the drug formulation, and design the extraction experiment accordingly. It is not only about analysis but equally about interpreting the results and making an appropriate risk assessment regarding the safety of the packaging container. Ultimately, the onus is on the pharma company and not on the manufacturer of the packaging material to ensure safety.

How do these studies help maintain safety of drugs?Investigation of materials that are coming into contact with pharmaceuticals and their possible interactions with these drugs is the basis of a better quality assurance for the packaging of the pharmaceutical products. India recently announced the opening of its new analytical Lab, specialised in conducting extractable and leachable studies in Mumbai boosting of state-of-the-art instrumentation namely, TDS - GC/MS, HPLC - DAD, UV, which will be used for detecting, measuring and identifying the wide variety of compounds and degradation products of these materials that tend to leach into the drug product.

The various thresholds that are considered for the evaluation of the daily dose of extractables rely not only on the toxicological relevance of the found extractables but also on the route of administration of the drug products. Therefore, the toxicological relevance of the found extractables is as such not sufficient to draw conclusions and must be linked to the daily dose. Depending on the final route of administration of the pharmaceutical formulation, different thresholds can be considered. For parenterals, other thresholds may be considered depending on whether the leachables is classified as sensitiser or irritant, or depending on the

Shibani [email protected]

The onus is on the pharma company and not on the manufacturer of the packaging material to ensure safety

…says Vincent Jeanguyot, Project Manager, Intertek. Here, he provides some insights on the importance of extractables and leachable studies.

genotoxicity of the leachable. For drug products which are applied orally, thresholds which derive from the specific migration limits given in the food regulation can even be considered.

The toxicological risks associated with extractables and leachables (E&L) can be clearly identified, thanks to extractables studies and toxicological assessments. Much more important: these risks can be managed. This is crucial not only for ethical reasons, but also because this can ensure a successful product launch or avoid endangering existing business.

How are Indian companies taking advantage of these studies to enhance the safety of their drugs?The perception of the industry towards E&L has been - and is still - largely influenced by the guidance from authorities, mainly the FDA and the European Medicine Agency (EMA).

Nowadays, the FDA, the EMA and the Product Quality Research Institute (PQRI) continue to guide the industry and new thresholds are being established, however, the pharmaceutical companies play also a leading role in trying to select ahead materials of better quality for their container closure systems.

The role of E&L assessments tends to become increasingly important. Not only because of the guidance or recommendations from the FDA or the EMA, but also because the drug manufacturers have understood and accepted the fact that the packaging and the various materials from their container closure systems could also impact their business by affecting the quality of the API. Depending on the outcome of an extractable study, various follow-up studies such as interaction studies and of course leachable studies may indeed be conducted within the frame of the approval process. This is clearly a reason why the designs of extractables studies and the associated protocols are crucial to guarantee a successful evaluation.

20 Insight & Outlook: Automation Trends

Radar level management

Cost-effective, reliable solution for process industry

The emergence of radar has been an important advancement in the level measurement field. Radar represents a cost-effective,

accurate solution that is immune to density and other process fluid changes as well as most vapour space conditions. Radar level measurement systems are available in contacting and non-contacting versions. Contacting type is generally a good fit for small spaces, and is an easy replacement for older technology such as displacers and capacitance probes. Non-contacting category is generally a better fit for dirty, viscous and/or corrosive applications and when agitators are present. Currently, contacting devices, called Guided-Wave Radar (GWR), are slightly more prevalent, primarily because they are capable of providing interface level measurement (eg oil and water), as well as standard direct level measurements. But both formats are now widely accepted by the process industry.

Contacting and non-contacting radarsWhile GWR works in many conditions and is not dependent on reflecting a signal off a flat surface, some precautions need to be taken with respect to probe choice. Several probe styles are available, and the application, length and mounting restrictions influence their choice. Unless a coax-style probe is used, probes should not be in direct contact with a metallic object, as that will impact the signal. Twin and coaxial probes are susceptible to clogging and build-up. If the application involves liquids that tend to be dirty, sticky or can coat, then only single lead probes should be used. For such applications, devices offering signal quality diagnostics can help the user determine if the probe needs to be cleaned and allows maintenance to be scheduled only when needed.

In general, GWR is not suitable for extremely viscous products where fluid flow is minimal. If GWR is used with very viscous fluids and is installed in a bypass chamber, the chamber should be heat traced and insulated to ensure fluidity. Furthermore, the connections from the tank to the chamber and the chamber’s diameter should be sufficiently large enough to allow good fluid flow.

With non-contacting radar, process conditions and installation constraints all need to be carefully considered. Non-contacting radar requires a clear, unobstructed view of a liquid surface. It is also important that there is an unrestricted mounting nozzle. The measured surface needs to be relatively flat, not slanted. Non-contacting radar gauges can handle agitation, but their success will depend on a combination of the fluid properties and amount of turbulence. Dielectric properties will also impact the measurement.

With low dielectric process fluids, much of the radiated energy is lost to the fluid, leaving very little energy to be reflected to the gauge. If the liquid surface is turbulent, whether from agitation, product blending, or splashing, more of

the signal is lost. So, a combination of low dielectric fluid and turbulence can limit the return signal to a non-contacting radar gauge. To overcome this, bypass pipes including self-contained chambers or stilling wells can be used to isolate the surface from turbulence.

High temperature applicationsIn applications with extreme temperature and pressure conditions, it is important to select a heavy-duty process seal with multiple layers of protection and a flexible assembly to handle the stresses and the forces induced. When measuring liquids at high temperatures in a chamber, it is important to insulate and heat trace the chamber. Fluctuations in temperatures alter the density and volume of the product, which then affects the level in the chamber.

Although radar technology is not affected by density changes, dielectric changes can have an impact. For boiler and feed water systems, where boiling water and high pressure saturated steam vapours are present, the returned signal from the surface becomes weaker as water temperature increases. If this is not taken into account, the saturated steam alters the propagation velocity of the radar signal and generates an error in the level reading proportional to the measured distance.

Interface applicationsLevel and interface measurement has been successful with GWR but presents

a separate set of challenges. The fluid with the lower dielectric must always be on top. The two liquids must have a dielectric difference of around 10, and the upper layer dielectric value must be known. Interface measurement applications, where the density of the two fluids is very close, or where emulsifier chemicals are used, can produce fairly large emulsion between the products. This may make the interface indistinct. Heavy and thick emulsion layers or liquid layers with similar dielectrics can pose a problem for GWR as the technology requires a distinct dielectric difference to detect the interface. GWR devices have proven to work, but success is difficult to predict. A manual adjustment of the interface threshold on the radar device may be required and a chamber/stilling well can help to minimise the emulsion.

Radar often works well in open air or non-metallic tank installations. However, in some cases outside disturbances may interfere with the radar signal. Here it is important to select a radar device with high resistance

to Electromagnetic Interference such as a GWR with a smart galvanic interface. For most open sump and well installations, an ultrasonic meter is a more cost-effective solution. However, should vapours be present, then a low frequency radar device is the preferred solution.

Overfill protectionIn critical level applications, it is necessary to use a minimum of two level technologies or devices and if the same technology is used, employ a voting scheme. Using technologies less influenced by process conditions, such as radar in combination with vibrating fork switches, is a good step to more accurate and reliable measurements. For radar, most failure modes relate to a loss of signal. High sensitivity normally results in high availabilities. High sensitivity is achieved by increasing the signal to noise ratio using technologies such as dual port and direct switch technology. Enhanced echologics – the ability to ignore false echoes – and smart software functions also improve the performance of the radar. Some GWR devices incorporate Reference Pulse Elimination software, which improves measurements in the near zone (high level areas), especially for low reflective targets. However, above a certain level, the surface echo may not be visible at all in the waveform, but the echologics are used to monitor the changes in the signal as the level gets close to the top, adding an extra layer of protection. Installation pitfallsA good installation is the key to success with radar. When installing a new radar device, it is usually on an existing nozzle. This nozzle can sometimes be too tall or narrow for the instrument. It is recommended that users try to minimise the height of the nozzle used. Ideally, nozzles should be at least two inches, but no more than six inches high for GWR. For non-contacting radar, it is preferable that the end of the antenna extends slightly beyond the nozzle. Another installation problem is when the nozzle is positioned directly over a pipe, baffle or some other obstruction.

As with all instrumentation, radar devices must be configured correctly in accordance with application needs. Special care must be taken when inputting thresholds for the radar signal. These will change depending on the medium being measured. For example, oil appears different to a radar device compared to water, and therefore requires very different threshold settings. However, today there are good set-up guides and functions such as measure and learn; so in most cases configuration is easily achieved in just a few steps.

Radar systems serve as efficient tools in the area of level measurement for liquids and slurries. These find usage in numerous applications and process conditions as they are unaffected by changes in fluid properties, be it temperature variations, viscosity, density, pressure and vapour conditions, dielectric changes, turbulence etc.

Sarah ParkerLevel Application Manager - Rosemount Business Unit, Emerson

[email protected]

While GWR works in many conditions and is not dependent on reflecting a signal off a flat

surface, some precautions need to be taken with respect to

probe choice.

21Projects

Hospital expansion - Phase II Project type: Facility expansionProject news:A world-class blood bank with first of its kind modular operation theatre with world class German technology (first hospital in the city to install such a facility) state-of-the-art Intensive Care Unit (ICU), and heart command cutting-edge labour delivery rooms with electric beds, and five star suite services ultramodern conference room, and lecture theatre for post graduate training, and continuing medical education series

Project location:Delhi Project cost: N.A.Implementation stage:Ongoing

Contact details:Karla Hospital & SRCNC Pvt LtdTulsi Dass Kalra Marg New Delhi 110015 Tel: 91-11-45005600 45005700 Fax: 91-11-25108119 (Helpline) 91-11-25100000Email Id: [email protected]

Multi-disciplinary hospital at Chandrasekharpur Project type:New facilityProject news: Around ` 100 crore would be spent on the proposed hospital, which will act as a referral hospital for the existing BMC-run hospitals and dispensaries.

Project location:Chandrasekharpur Project cost:` 100 crore Implementation stage:Planning

Contact details:Bhubaneswar Municipal CorporationVivekananda Marg, Bhubaneswar - 751014 OdishaTel : 91-674-2431403 Email: [email protected]

Pharmaceutical manufacturing facility in Vishakhapatnam Project type: New facilityProject news:Shasun Pharmaceuticals will invest ` 250 crore in expansion activities, including setting up of new plants, in the next financial year 2013. Company will invest ̀ 250 crore in ongoing expansion plans of the company in FY 13. These include building a manufacturing facility in Vishakhapatnam and increasing the capacity of existing plants.

Project location:India Project cost: ` 250 croreImplementation stage:Ongoing

Contact details:Shasun Pharmaceuticals LtdBatra Centre, 28, Sardar Patel Road, Guindy, Chennai 600032, Tamil Nadu Tel :91-44-43446700 Fax : 91-44-22350278 Website: www.shasun.com

Setting up a 150-bedded hospital in Kerala Project type:New facilityProject news:The company is in talks with Le Meridian Hotel, Kochi, for setting up a hospital on their land. The group plans to install MRI-guided High-Intensity Focused Ultrasound (HIFU) solution from Philips Healthcare worth around ` 5 crore each, in four of its hospitals. Project location:Kerala Project cost:` 150 crore Implementation stage:Ongoing

Contact details:Apollo Hospitals645, 646th Road, Tondiarpet, Chennai, Tamil NaduTel: 91-40-23241066Email: [email protected]

Setting up new hospitals Project type: New facility Project news:Fortis Healthcare (India) Ltd has announced the launch of two hospitals in Hyderabad, thus increaseing its network of hospitals to 68 hospitals. The super-speciality 150-bedded hospital in Hyderabad will be functional in 2013.

Project location:Hyderabad Project cost: N.A. Implementation stage: Planning

Contact details:Fortis Healthcare (India) Ltd.Upper Basement, Rehabilitation Building Fortis Escorts Heart Institute Okhla Road New Delhi-110 025 Tel: 91- 11- 47135328, 47135439 Fax: 91- 11- 47135315 Website: www.fortishealthcare.com

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

22 Tenders

Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India

Tel: Fax: Email: [email protected]

Raman spectrometer/Microscope system Org : Indian Institute of Technology (IIT) TRN : 14848412Desc : Supply, installation, commissioning & satisfactory demonstration of Raman spectrometer/Microscope system BOD : March 11, 2013Loc : Indore, Madhya Pradesh BT : Domestic (NCB)

UV spectophtometer Org : National Centre For Integrated Pest Managment (NCIPM) TRN : 14852376Desc : Purchase of UV spectophtometer BOD : March 11, 2013Loc : New Delhi BT : Domestic (NCB)

Plasma mass spectrometer Org : HEJ Research Institute of Chemistry TRN : 14825239Desc : Import of inductively coupled plasma mass spectrometerBOD : March 12, 2013Loc : Karachi, Pakistan BT : Global (ICB)

Spectrophometer with gradient PCR machine Org : All India Institute Of Medical Sciences (AIIMS)

TRN : 14806837Desc : Supply of spectrophometer with gradient PCR machine BOD : March 12, 2013Loc : New Delhi BT : Domestic(NCB)

Refrigerate centrifuge Org : All India Institute Of Medical Sciences (AIIMS) TRN : 14806833Desc : Supply of refrigerate centrifuge BOD : March 12, 2013Loc : New Delhi BT : Domestic(NCB)

Refrigerated table top centrifuge osmometer Org : All India Institute Of Medical Sciences (AIIMS) TRN : 14806823Desc : Provision of refrigerated table top centrifuge osmometer BOD : March 12, 2013Loc : New Delhi BT : Domestic (NCB)

Compact mass spectrometer Org : Department Of Atomic Energy TRN : 14806076Desc : Provision of compact mass spectrometer along with accessories

BOD : March 13, 2013Loc : Mumbai, Maharashtra BT : Domestic (NCB)

High performance optical spectrum analyser Org : Central Glass and Ceramic Research Institute (CGCRI) TRN : 14826672Desc : Purchase of high performance Optical Spectrum Analyser (OSA) in wavelength range 600-1700 nm BOD : March 13, 2013Loc : Kolkata, West Bengal BT : Domestic (NCB)

Vector network analyser Org : Department Of Atomic Energy TRN : 14806754Desc : Supply & installation of vector network analyser BOD : March 14, 2013Loc : Mumbai, Maharashtra BT : Domestic (NCB)

Hand-held spectrum analyser with accessories Org : National Remote Sensing Centre TRN : 14827002Desc : Supply of hand-held spectrum analyser with accessories BOD : March 15, 2013Loc : Hyderabad, Andhra Pradesh BT : Domestic (NCB)

Latest Popular Tenders Brought to you by www.tendersinfo.com

An

as well...thatinviterewards

Dear Reader,

‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry.

You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words.

The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition.

Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80,000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost.

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Thanking you,

Yours sincerely,

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced the launch of iPHEX 2013. Billed as ‘India’s own pharmaceutical show’, this event will be held in Mumbai from April 24-26, 2013 with the support from the Ministry of Commerce & Industry, Department of Commerce and Government of India. Over 400 leading Indian companies are expected to showcase the best of pharma products before 5,000 business visitors including overseas buyers and drug regulators. The event is expected to offer a good opportunity for international buyers and regulators to visit India and evaluate how well structured and regulated the Indian pharma industry is at the moment.According to Pharmexcil, iPHEX 2013 will immensely help its members to promote the quality and affordability aspect as envisaged in ‘Brand India Pharma Campaign’. The campaign has been initiated by Ministry of Commerce and executed by Pharmexcil in association with India Brand Equity Foundation.Dr P V Appaji, Director General, Pharmexcil, said, “iPHEX 2013 will

be a complete value chain show and Pharmexcil is creating a sustainable pharma industry platform with a special focus on export market development. The exports growth story is one to be proud of.”With increasing R&D spends, Indian pharmaceutical sector has become a cost-effective centre for world-class research as also for contract R&D. Indian companies in recent years have produced many cost-effective drugs that are affordable to the masses. In this context, Ashutosh Gupta, Vice Chairman, Pharmexcil, said, “We are making concerted efforts to promote India’s status as the manufacturing hub of the world.”

“iPHEX 2013 will be the biggest industry exposition in India showcasing the diverse range of products and will include formulations, APIs, Ayush, nutraceuticals, health services, biotechnology and biotechnology products, R&D services etc,” informed Bhavin Mehta, Committee Chief, iPHEX and CoA Member, Pharmexcil. Pharmexcil plans to organise several thematic seminars and conferences on the sidelines as well. “These will include pharma sector investments, R&D and innovation, overseas market entry strategies etc,” added Mehta.

In Conversation With 16K V Subramaniam President & CEO, Reliance Life Sciences

Special Focus 18The cleanoom market in India Set for big growth

Policies & Regulations 28FDI in pharma: Embrace or fear? Anup P Shah Partner, Pravin P Shah & Co

Interface 27 Sheesh Gulati Chief Executive Officer, MeasureTest Corporation

Bhasker Iyer named Divisional Vice President, India - Abbott Pharmaceuticals Business Bhasker Iyer has been named Divisional

Vice President, India Commercial Operations, Abbott Established Pharmaceuticals, effective February 18, 2013. Bhasker Iyer will report into Mike Warmuth, Executive Vice President, Established Pharmaceuticals Division, Abbott. Iyer brings over 30 years of experience in the pharma industry. He held the position of President, India and Emerging Markets, Wockhardt. Abbott’s pharmaceuticals business in India - Abbott India Ltd, Abbott Healthcare Solutions and Abbott True Care - will report into this newly established position. Iyer will work with the business leadership teams to identify further opportunities to expand access to Abbott’s broad portfolio of quality products in India. Warmuth said, “The establishment of this position reinforces the focus of the company’s strategy in India to bring quality medicines to patients that make a difference in their lives and to ensure patients and the healthcare community has access to these medicines.”

Tata Capital acquires minority interest in Marck BiosciencesTata Capital Healthcare Fund acquired minority interest of 13 per cent in Marck Biosciences Ltd along with 6 per cent stake in IFCI Venture making total stake holding of Tata Capital between 19 to 22 per cent in Marck Biosciences. Bhavesh Patel, MD, Marck Biosciences, said, “It is a sustained growth phase for us at Marck Biosciences as we are investing ` 80 crore in the new expansion project. The fund infusion from Tata Capital will be invested for further expansion of capacities of the new project, which will have state-of-the-art technology. Our entire project cost is expected to be around ` 80 crore and hence we will also be going in for further funding through debt route. We expect returns from the funds infused within 6 to 8 months.”

16 - 2 8 F e b r u a r y 2 013 I Vo l 1 I N o 16 I `10 0


iPHEX 2013 to host over 400 international buyers and regulators

www.modernpharma.in

Patel

SCHOTT KAISHA inaugurates India’s first fully automated plant for pharma packaging

With the pharmaceutical market in India expanding by approximately 14 to 17 per cent per year, the packaging market is expected to grow in line with the overall pharma market by about 11 per cent annually. Keeping in mind the growing needs of the industry, SCHOTT KAISHA inaugurated its new pharmaceutical packaging plant in Jambusar, Vadodara, Gujarat. This greenfield investment of ` 135 crore is set to increase the company’s production capacity in India by 50 per cent to around 2 billion ampoules and vials per year. This packaging plant complements

an existing production facility in Daman and enhances SCHOTT KAISHA’s competitive advantage substantially. With high-end safety precautions in place and a strong commitment to GMP, SCHOTT KAISHA’s 20 acre completely automated plant is set to revolutionise India’s pharma packaging industry. SCHOTT KAISHA’s primary aim remains to serve the Indian market.“We see a steadily rising demand

for locally manufactured primary packaging that meets the rising quality demands,” said Kairus Dadachanji, Managing Director, SCHOTT KAISHA.

He added, “Our new state-of-the-art factory sets new standards in India. This investment will result in better quality opportunities for our customers. In other words, we will be helping the Indian pharmaceutical industry to achieve its own growth objectives.”The new plant in Jambusar has 20

production lines for ampoules and 16 for vials, with scope for further expansion. Its fully automated production process uses high-end robotic feeding technology for tube-loading as well as high-precision camera inspection systems. World market leading SCHOTT FIOLAX® tubes are used as base material. The facility is India’s first pharmaceutical packaging plant meeting global standards with an ISO 15378 certification. “KAISHA’s deep market knowledge

about India and SCHOTT’s world-class technology create a perfect partnership,” emphasises Prof Udo Ungeheuer, Chairman of the Board of Management, SCHOTT AG. “The SCHOTT group is highly committed to its pharmaceutical business. Our continuous investments in India demonstrate our ambition. More than one hundred years of experience in setting the world’s highest technology

standards turn us into the ideal partner for India’s ambitious and fast growing pharmaceutical industry,” he added. SCHOTT KAISHA is confident of

exceeding overall market growth in the future with expectations of crossing ` 240 crore mark by the end of 2013. The Indo-German company offers a

complete range of primary tubular glass packaging: Products comprise ampoules, vials, cartridges for pen and auto injectors as well as sterile pre-fillable glass syringes. Dadachanji added, “Although our main concentration is currently on ampoules and vials, the syringe market is expected to see a healthy growth in the near future.” Pallavi Mukhopadhyay

(L-R): Prof Ungeheuer; Dadachanji and Dr Juergen Sackhoff, EVP, Pharmaceutical Systems at the inauguration

Dr Appaji addressing the seminar

Iyer

Manas R. BastiaSenior EditorModern Pharma

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23Event List

N A T I O N A L E V E N T SNutra India SummitNutra India Submit enjoys its 8th

successful year in showcasing health care and wellness products, nutritional food supplements and natural products. There will be conferences, forums, award ceremonies and several other programs that will be running simultaneously with the exhibition and the summits will be visited by 500 delegates from across 12 countries of the world such as Canada, Japan, USA and others. The show will be hosted by over 60 exhibitors coming from different departments in the nutritional sector. 95 percent amongst the suppliers think that this event is the optimum place where new contacts and business networking opportunities can be conducted; March 13-16, 2013, Vivanta by Taj - President, Mumbai

For details contact:M M Activ, BengaluruTel: +91-80-41131912Fax: +91-80-41131914Email: [email protected]: www.mmactiv.in

Pharma Pro&Pack 2013 PHARMA Pro&Pack Expo 2013 will offer an opportunity to expand business in the Indian and international pharma industry. Various industry majors from India and across the world will be present at the Technology Show. The event will help facilitate meetings with clients & prospective customers at one place on one platform thus expanding business to new customers locally &

internationally; April 24-26, Bombay Exhibition Centre, Mumbai

For details contact:GPE Expo Pvt LtdTel: 91-79-40008253Email: [email protected]: www.pharmapropack.com

iPHEX 2013iPHEX plays a major role in introducing the Indian market to the advanced medicinal products. This show coverS up the entire medical industry, starting from hospital services, medicines, pharmaceuticals and surgical sectors. 250 companies have already registered to participate in this event as they think that this podium is best way to reach out to the customers and publicize their brand name; April 24-26, 2013, Bombay Exhibition Center (BEC), Mumbai

For details contact:Pharmaceuticals Export Promotion CouncilTel: +91-40-23735462/23735466Fax: +91-40-23735454Email: [email protected]: www.iphex-india.com

PHARMAbiotikaPharmabiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference. The event will help in meeting

the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives, September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar

For details contact:Human Crayon Management Services Pvt LtdTel: +91- 120 – 6528801Email: [email protected] Website: www.pharmabiotika.com

Indian Pharma ExpoThe Indian Pharma Expo 2013 will be one of the a unique pharma events inIndia that will serve as a perfect platform for pharma entrepreneurs andinvestors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and the largest suppliers and distributors of pharma products under one roof in order to facilitate the exchange of ideas for better growth of the industry; September 20-21, 2013, Pragati Maidan, New Delhi

For details contact:UBM Medica India Pvt LtdTel: +91-22-66122600 / 66122673Fax: +91-22-66122626Email: [email protected]: www.ubmindia.in

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

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

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

Electrical & Electronics, Material Handling and Safety Equipment.

HYDERABADAndhra Pradesh, May 31- June 3, 2013

For detailsNetwork18 Media & Investments Ltd

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

I N T E R N A T I O N A L E V E N T SInfarma ExpoInfarma Expo showcases the rapidly progressing scenario of the pharmaceutical industry of Spain. It aims at bringing together world renowned companies as well as newly launched companies on one platform. CEOs & top executives, purchase executive, manufacturing engineers of pharmaceutical companies, R&D professionals, pharma machinery suppliers & distributors, pharma consultants, scientists, government experts are the target audience; March 5-7, 2013, Fira de Barcelona Gran Vi, Barcelona, Spain

For details contact:Interalia Ferias Profesionales Y Congresos SATel: +34-93-4161466Fax: +34-93-4150095Email: [email protected]: www.infarma.es

EAHP‘Improving patient outcomes: a shared responsibility’ is the theme of the 18th Congress of European Association of Hospital Pharmacists (EAHP). This topic covers two of the major goals of the association: the commitment to the patient and the importance of collaboration with other health professionals. Hospital pharmacists are the stakeholders in optimising the medication of inpatients, but their responsibility does not end at the interface to primary care. Due to the

fact that this is prone to errors, the Congress will focus on the different aspects of the interface with the scope of helping all participants to understand the origin of faults, March 13-15, 2013, Paris, France For details contact:EAHPTel: +32-2-741-6827Fax: +32-2-734-7910Email: [email protected]: www.eahp.eu

International Conference on Life Science & Biological EngineeringThe aim objective of LS&BE 2013 is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in networking and digital society. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; March 15-17, 2013, Tokyo, Japan

For details contact:Kwansei Gakuin UniversityTel: +81 798 54 7394Fax: +81 798 54 6082Email: [email protected] : www.lsbe.org

8th Annual Drug Discovery Chemistry Conference This is one of the few events specifically for medicinal chemists working in pharma & biotechnology sectors. It is focused on discovery & optimisation challenges of small molecules. Nobel Laureate will give the keynote address. The meeting will discuss Anti-Inflammatories, Fragments, Macrocyclics, Kinase Inhibitors, PPI & GPCRs. The event offers opportunities for scientists to create unique programs according to personal interests; April 16-18, 2013 Hilton San Diego Resort & Spa, San Diego, CA, USA

For details contact:Cambridge Healthtech InstituteTel: +1 781-972-5400Fax: +1 781-972-5425Email:[email protected]: www.drugdiscoverychemistry.com

International Congress of Toxicology 2013The theme for the conference is “From Basic Science to Clinical and Environmental Outcomes”. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist of keynote/distinguished lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting

will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea

For details contact:ICT XIII SecretariatTel: +82-2-557-8422Fax: +82-2-566-6084Email: [email protected]: www.ict2013seoul.org

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

For details contact:Terrapinn Pte LtdTel: +65 6222 8550Fax: +65 6226 3264Email:[email protected]: www.terrapinn.com

The information published in this section is as per the details furnished

by the respective organiser. In any case, it does not represent the views of

Modern Pharma.

24 Event Preview

8th Nutra India Summit

Set to further the Indian nutraceutical growth strory

The rapid transformation and rise of the healthcare sector of India has resulted in an increasing interest in health

and wellness and also nutraceuticals, nutritionals and naturals finished products category across the Asian subcontinent.

Amid these developments, the 8th Nutra India Summit, a show on nutraceuticals, functional food, dietary supplements and ingredients, is set to be held during March 13-16, 2013 at Vivanta by Taj - President and World Trade Centre in Mumbai.

Flourishing businessA robust economic growth has given many international brands a reason to come to India and flourish in the Indian market with its array of Fast Moving Health Products (FMHG), and provided increased opportunity for Indian companies & enterpreneurs for business partnerships.

The theme of the event is disease management, health & wellness through nutraceuticals, nutritionals & naturals.

A panel discussion will deliberate on the new products in the nutraceutical market and health food sector with a special focus on building a strong immunity with nutraceuticals. It will be held with the support of Indian Diabetic Association (IDA) and will receive participation from all levels of the fraternity.

Council of Scientific and Industrial Research (CSIR), International Society for Nutraceuticals, Nutritionals and Naturals (ISNNaN) and MM Activ Sci-Tech Communications are the organisers of Nutra India Summit, while Herbalife is the event sponsor. Sami Direct Marketing Ltd, British Biological, OmniActive, Zeon Life Sciences, Kyowa Hakko, Enzo Nutraceuticals, Nexira India, TCI Company India, Heal Wellness are the other sponsors of the Summit.

Events to look forward toAn International conference will be held where impact speakers from across globe will discuss successful marketing strategies and current industry concerns that influence the growth and development of this industry.

NuFFooDS, a health & food expo will be held where industry leaders and small scale enterprises can have face-to-face interactions. It will also witness new product launches. It

will have more than 75 exhibitors across the nutraceutical, functional foods, dietary supplement spectrum and will attract more than 3,000 business visitors.

The planned CEO Summit will be attended by business leaders and a special panel discussion by a group of leading CEOs will discuss the next frontiers of the industry.

The dieticians and nutritionists forum will deliberate on the role of nutraceuticals and health foods in improving the lifestyle and wellbeing of the society.

A poster session on ‘Walkway of Discovery’ is planned, which will aid young researchers from various universities across the globe share to portray their ideas and thoughts in form of interactive posters. The contents of selected posters will be printed in the 8th Nutra India Summit Program Document by way of abstracts, which will be distributed to all the delegates of Nutra India Summit 2013.

A special interaction of visionary thoughts & ideas and ways to ideate perceptions and make right streaming for business will be held. Mentors and key opinion leaders will share their experience and visions.

An award ceremony will felicitate the hard work and passion displayed by the industry achievers and winners in their own area of work. Also, awards for best exhibitors and posters displayed at the Summit will be announced.

Further, InterlinX, a partnering tool to schedule B2B meetings with delegates will be introduced at the event for the first time. The interactive partnering software will enable individuals to know who are the other delegates attending well before you attend the event. The software will enable delegates to find and contact and schedule one-to-one meetings with potential partners leading to tie ups and collaborations.

Niket Donde, Event Secretariat, Mumbai, says, “The health and wellness industry in India is witnessing a phenomenal growth in the last

three years. According a report by Federation of Indian Chambers of Commerce & Industry (FICCI) and PricewaterhouseCoopers (PwC), the overall wellness market in India is estimated at ` 490 billion. Riding this wave of growth, the 8th edition of Nutra India Summit will principally focus on health & wellness. The global scientific and business community including industry captains, policymakers, R&D heads, doctors & nutritionists, suppliers, equipment manufacturers and participants from the food processing & analytical industry will look forward to a strong exchange of ideas, R&D advances and collaborative opportunities at the Summit.”

This Nutra India Summit will provide global opportunities for Indian companies as well as exploring trends in the Japanese functional food market, R&D, export and functional food industry in Brazil and Latin America. European Nutraceutical Association is also supporting the event. Other expected delegates will be medical practitioners, dieticians and nutrtionists, international and business representatives, supermarkets, retail chains and business stores, lifestyle clubs, wellness spas and health consumers

Highlights of Nutra India Summit 2012The 7th nutraceutical conference was organised by Council of Scientific and Industrial Research, international Union of Food Science and Technology and MM Activ Sci Tech Communications and hosted by the Government of Karnataka. Over 600 delegates from China, Belgium, Japan, etc participated.

The international conference was addressed by 70 national and international experts. NuFFooDS Expo was participated by 70 exhibitors from various sectors of the nutra industry. Over 3,000 business visitors were present at the NuFFooDS Expo.

With the burgeoning interest of national and international players in the Indian healthcare and wellness market, the 8th Nutra India Summit is a perfect setting to ride on the growth wave of the nutraceuticals. This event aims to collaborate among researchers, doctors, suppliers, buyers, sellers, visionaries and policymakers to facilitate better interaction and generate thriving new businesses.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Several industry stalwarts at the previous edition

The Summit in process last year

25Book Review

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

If ever you wanted to read about European herbal techniques and principles, this is your one-stop solution for the same. This mammoth text describes in detail various European ‘tea-based’ remedies and their basic herbs in the form of detailed monographs. The intent of the book is to empower a herbal pharmacist and enable him to serve up concoctions for various illnesses with conviction. The initial pages of the book deal with the basics and history of phytotherapy and the art of herbal tea making. The majority of the text is monographs of individual herbs, each of which is described in detail. Coloured photographs of individual plants and its parts make the text more appealing. The book is a must have reference guide for everyone interested in herbal medicine, pharmacists and physicians actively practicing herbal medicine, researchers and historians.

Fundamentals of Pharmacognosy and Phytotherapy

Herbal Drugs and Phytopharmaceuticals: A handbook for practice on a Scientific Basis

Editors: Heinrich, Joanne Barnes, Simon Gibbons & Elizabeth Williamson

Price: ` 2,495

Publisher: Pharmaceutical PressDistributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: [email protected]

Editors: Norman Grainger Bisset & Max Wichtl

Price: ` 2,995

Publisher: Informa HealthcareDistributor:Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: [email protected]

The history of pharmaceuticals has many examples of blockbuster molecules being originally derived from a plant, animal or marine source. The book comprehensively describes the various aspects of pharmacognosy; the science of biogenic or nature derived pharmaceuticals and poisons. The book is divided into two basic parts. Part ‘A’ details in its 11 chapters the fundamental concepts and processes in pharmacognosy. The initial five chapters detail the history of natural medicine and the botanical principles governing plant biology. The chapters on natural product chemistry, methods of extraction, production, standardisation and quality control give an industrial aspect to the science of natural products. Each chapter is explained in an easy and lucid language. Illustrations and figures make sure that the reader grasps the concepts easily. The second part ‘B’ of the book takes a look at naturally derived pharmaceutical products and their applications in various clinical conditions in an organ system-based manner. Various therapies, both ancient and modern, are discussed in this section. Overall, it is a great book for undergraduates, post graduates, botanists, researchers, drug analysts and practitioners of natural medicine.

26 Products

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27Products

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the respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma

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Form IV (See Rule 8) (Press and Reg. of Books Act, 1867)1. Place of Publication: Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar

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Mumbai - 400 028

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Mumbai - 400 028

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Mumbai - 400 028

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Details of the shareholders of Network18 Media & Investments Limited who hold more than 1% of the paid up equity capital of the Company as on 20-02-2013 are given below:a. RRB Mediasoft Private Limited, 403, Prabhat Kiran, 17, Rajendra

Place, New Delhi - 110 008

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I, Lakshmi Narasimhan, hereby declare that all particulars given above are true to the best of my knowledge and belief.

Dated: 20th February 2013

LAKSHMI NARASIMHAN

Signature of the publisher

** ownership of this magazine stands transferred from Infomedia Press

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to Network18 Media & Investments Limited (Network18) in pursuance of the

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and the necessary approval of Ministry of Information and Broadcasting is

being obtained.

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Liquid filling machineThe four-head liquid filling machine is a highly versatile machine for filling foamy as well as other liquids into containers. It has a unique bottle separation method

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The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced the launch of iPHEX 2013. Billed as ‘India’s own pharmaceutical show’, this event will be held in Mumbai from April 24-26, 2013 with the support from the Ministry of Commerce & Industry, Department of Commerce and Government of India. Over 400 leading Indian companies are expected to showcase the best of pharma products before 5,000 business visitors including overseas buyers and drug regulators. The event is expected to offer a good opportunity for international buyers and regulators to visit India and evaluate how well structured and regulated the Indian pharma industry is at the moment.

According to Pharmexcil, iPHEX 2013 will immensely help its members to promote the quality and affordability aspect as envisaged in ‘Brand India Pharma Campaign’. The campaign has been initiated by Ministry of Commerce and executed by Pharmexcil in association with India Brand Equity Foundation.Dr P V Appaji, Director General,

Pharmexcil, said, “iPHEX 2013 will

be a complete value chain show and Pharmexcil is creating a sustainable pharma industry platform with a special focus on export market development. The exports growth story is one to be proud of.”

With increasing R&D spends, Indian pharmaceutical sector has become a cost-effective centre for world-class research as also for contract R&D. Indian companies in recent years have produced many cost-effective drugs that are affordable to the masses. In this context, Ashutosh Gupta, Vice Chairman, Pharmexcil, said, “We are making concerted efforts to promote India’s status as the manufacturing hub of the world.”

“iPHEX 2013 will be the biggest industry exposition in India showcasing the diverse range of products and will include formulations, APIs, Ayush, nutraceuticals, health services, biotechnology and biotechnology products, R&D services etc,” informed Bhavin Mehta, Committee Chief, iPHEX and CoA Member, Pharmexcil. Pharmexcil plans to organise

several thematic seminars and conferences on the sidelines as well. “These will include pharma sector investments, R&D and innovation, overseas market entry strategies etc,” added Mehta.

In Conversation With 16K V Subramaniam President & CEO, Reliance Life Sciences

Special Focus 18The cleanoom market in India Set for big growth Policies & Regulations 28FDI in pharma: Embrace or fear? Anup P Shah Partner, Pravin P Shah & Co

Interface 27 Sheesh Gulati Chief Executive Officer, MeasureTest Corporation

Bhasker Iyer named Divisional Vice President, India - Abbott Pharmaceuticals Business Bhasker Iyer has been named Divisional Vice President, India

Commercial Operations, Abbott Established Pharmaceuticals, effective February 18, 2013. Bhasker Iyer will report into Mike Warmuth, Executive Vice President, Established Pharmaceuticals Division, Abbott. Iyer brings over 30 years of experience in the pharma industry. He held the position of President, India and Emerging Markets, Wockhardt. Abbott’s pharmaceuticals business in India - Abbott India Ltd, Abbott Healthcare Solutions and Abbott True Care - will report into this newly established position. Iyer will work with the business leadership teams to identify further opportunities to expand access to Abbott’s broad portfolio of quality products in India. Warmuth said, “The establishment of this position reinforces the focus of the company’s strategy in India to bring quality medicines to patients that make a difference in their lives and to ensure patients and the healthcare community has access to these medicines.”

Tata Capital acquires minority interest in Marck BiosciencesTata Capital Healthcare Fund acquired minority interest of 13 per cent in Marck Biosciences Ltd along with 6 per cent stake in IFCI Venture making total stake holding of Tata Capital between 19 to 22 per cent in Marck Biosciences. Bhavesh Patel, MD, Marck Biosciences, said, “It is

a sustained growth phase for us at Marck Biosciences as we are investing ` 80 crore in the new expansion project. The fund infusion from Tata Capital will be invested for further expansion of capacities of the new project, which will have state-of-the-art technology. Our entire project cost is expected to be around ` 80 crore and hence we will also be going in for further funding through debt route. We expect returns from the funds infused within 6 to 8 months.”

16 - 2 8 F e b r u a r y 2 013 I Vo l 1 I N o 16 I `10 0


iPHEX 2013 to host over 400 international buyers and regulators

www.modernpharma.in

Patel

SCHOTT KAISHA inaugurates India’s first

fully automated plant for pharma packaging

With the pharmaceutical market in India expanding by approximately 14 to 17 per cent per year, the packaging market is expected to grow in line with the overall pharma market by about 11 per cent annually. Keeping in mind the growing needs of the industry, SCHOTT KAISHA inaugurated its new pharmaceutical packaging plant in Jambusar, Vadodara, Gujarat. This greenfield investment of ` 135 crore is set to increase the company’s production capacity in India by 50 per cent to around 2 billion ampoules and vials per year. This packaging plant complements

an existing production facility in Daman and enhances SCHOTT KAISHA’s competitive advantage substantially. With high-end safety precautions in place and a strong commitment to GMP, SCHOTT KAISHA’s 20 acre completely automated plant is set to revolutionise India’s pharma packaging industry. SCHOTT KAISHA’s primary aim remains to serve the Indian market.

“We see a steadily rising demand for locally manufactured primary packaging that meets the rising quality demands,” said Kairus Dadachanji, Managing Director, SCHOTT KAISHA.

He added, “Our new state-of-the-art factory sets new standards in India. This investment will result in better quality opportunities for our customers. In other words, we will be helping the Indian pharmaceutical industry to achieve its own growth objectives.”

The new plant in Jambusar has 20 production lines for ampoules and 16 for vials, with scope for further expansion. Its fully automated production process uses high-end robotic feeding technology for tube-loading as well as high-precision camera inspection systems. World market leading SCHOTT FIOLAX® tubes are used as base material. The facility is India’s first pharmaceutical packaging plant meeting global standards with an ISO 15378 certification. “KAISHA’s deep market knowledge

about India and SCHOTT’s world-class technology create a perfect partnership,” emphasises Prof Udo Ungeheuer, Chairman of the Board of Management, SCHOTT AG. “The SCHOTT group is highly committed to its pharmaceutical business. Our continuous investments in India demonstrate our ambition. More than one hundred years of experience in setting the world’s highest technology

standards turn us into the ideal partner for India’s ambitious and fast growing pharmaceutical industry,” he added.

SCHOTT KAISHA is confident of exceeding overall market growth in the future with expectations of crossing ` 240 crore mark by the end of 2013. The Indo-German company offers a

complete range of primary tubular glass packaging: Products comprise ampoules, vials, cartridges for pen and auto injectors as well as sterile pre-fillable glass syringes. Dadachanji added, “Although our main concentration is currently on ampoules and vials, the syringe market is expected to see a healthy growth in the near future.” Pallavi Mukhopadhyay

(L-R): Prof Ungeheuer; Dadachanji and Dr Juergen Sackhoff, EVP, Pharmaceutical

Systems at the inauguration

Dr Appaji addressing the seminar

Iyer

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RNI No: MAHENG / 2008 / 27125, o R No: G / NM / 122 / 2011 1 , o , G , M 00 001

1 20 E Mo , o : 1 E Mo

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Modern Pharma - 1-15 March 2013

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