modern pharmaceuticals - may 2010

Als

o av

aila

ble

in S

ri La

nka,

Mal

aysi

a, S

inga

pore

, Tha

iland

, Tai

wan

, Chi

na &

Hon

g K

ong

Modern

Pharm

aceuticals

(M

ay-1

0)

Insert

FIC

-A

Modern

Pharm

aceutic

als

(May-1

0) In

sert F

IC-B

May 2010 Modern Pharmaceuticals 7

E D I TO R I A L

Published in association with

Editorial Advisory BoardAjit SinghChairman, ACG Worldwide & Head, ISPE

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Editor: Manas R Bastia

Sr. Features Writer: Kavita Tate-Nadkarni

Features Writer: Saloni Vora

Research Desk: KTP Radhika Jinoy, Sumedha Mahorey

Correspondents Desk: Prasenjit Chakraborty, Rachita Jha, Geetha Jayaraman, Shivani Mody, Ayesha Augustine, Divya Karmakar

Copy Desk: Meghanadan Sudhakaran, Marcilin Madathil, Swati Sharma,Priyadarshini Basu

Products Desk: Michael Anthony, Sudheer Vathiyath, A Mohankumar

Group Photo Editor & Creative Head: Shiresh R Karrale

Design: Sachin Bhogate

Production: Vikas Bobhate, Pravin Koyande, Dnyaneshwar Goythale,Kalpesh Dhanmeher, Ravikumar Potdar, Sanjay Shelar, Lovey Fernandes, Pukha Dhawan, Varsha Nawathe, Akshata Rane, Abhay Borkar

Branding & Marketing: Jagruti Shah, Ganesh Mahale

Chief Executive Officer: Lakshmi Narasimhan

Associate Vice President : Sudhanva Jategaonkar

Subscription: Sunder Thiyagarajan, General Manager-Copy SalesSheetal Kotawdekar-Senior Manager Tel: 91-22-3003 4632 / 31 Email: [email protected]

Editorial & Business Office: Infomedia 18 LtdSpecial Interest Publications Division, ‘A’ Wing, Ruby House, J. K. Sawant Marg, Dadar (W), Mumbai 400 028Tel: 91-22-3003 4669 / 4671 Fax: 91-22-3003 4499 Email: [email protected]

Other Business Offices

Ahmedabad: (Shashin) Tel: 079-39826432 Fax: 079-39826464Email: [email protected]

Bengaluru: (Mahadev B) Tel: 080-30010900 Fax: 080-30010999 Email: [email protected]

Chennai: (Hari) Tel: 044-39864200 Fax: 044-28295060Email:[email protected]

Cochin: (Robin) Tel: 0484-4054380/90 Fax: 0484-4054370Email: [email protected]

Coimbatore: (Prakash) Tel: 0422-3092600 Fax: 0422-3092666Email: [email protected]

Hyderabad: (Rahul) Tel: 040-30647600 Fax: 040-30647676Email: [email protected]

Indore: (Ameya) Tel: 0731-3074876 Fax: 0731-3074882Email: [email protected]

Jaipur: (Saurabh) Tel: 0141-3007414; 3007411 Fax: 0141-2213728Email: [email protected]

Kolkata: (Deb Ranjan) Tel: 033-22658637/8638 Fax: 033-22652964Email: [email protected]

Ludhiana: (Jasmeet) Tel: 3026198, 3026199, 3026200, 3026201 Fax: 3026198 Email: [email protected]

Mumbai: (Jameel) Tel: 022-30034640 Fax: 022-30034499Email: [email protected]

New Delhi: (Jhuma) Tel: 011-66303278 Fax: 011-23327884 Email: [email protected]

Pune: (Rohit) Tel: 020-66031234 Fax: 020-66010486Email: [email protected]

Surat: (Sunil) Tel: 0261-2630181 Fax: 0261-2630974Email: [email protected]

Vadodara: (Samarth) Tel: 0265-3926500/01 Fax: 0265-2356013Email: [email protected]

Overseas Contacts: Ringier Trade Media Ltd

China: Tel: +86 21 6289 5533 Fax: +86 21 6247 4855Email: [email protected]

Hong Kong: Tel: +852 2369 8788 Ext. 19 Fax: +852 2869 5919Email: [email protected]

Taiwan: Tel: +886 4 2329 7318 Fax: +886 4 2310 7167Email: [email protected]

Singapore: Tel: +65-6288 5586 Fax: +65-6288 3301Email: [email protected]

Germany, Austria, Switzerland: Tel: +41 44 734 0472, Fax: +41 44 734 0680 Email: [email protected]

USA: Tel: (513) 527-8800, Fax: (513) 527-8801Email: [email protected]

� Issue Price: Rs 100 � Annual Subscription: Rs 799

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Infomedia 18 Ltd and printed at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J.K.Sawant Marg, Dadar (W), Mumbai - 400 028.

Modern Pharmaceuticals is registered with the Registrar of Newspapers of India under No. 14798/2005. Views and opinions expressed in this publication are not necessarily those of Infomedia 18 Limited. Infomedia 18 Limited reserves the right to use the information published herein in any manner whatsoever. While every effort has been made to ensure accuracy of the information published in this edition, neither Infomedia 18 Ltd nor any of its employees accept any responsibility for any errors or omission. Further, Infomedia 18 Ltd 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. No part of this publication may be reproduced in any form without the written permission of the publisher. All rights reserved.

Editor: Manas R Bastia

Bridging the technology gap

though there are several challenges before the global pharma industry today, some of the key ones include dwindling drug pipeline, cost-effective product delivery, de-risking manufacturing automation possibilities,

thinner bottomline etc. More importantly, these have immediate implications for the pharma value chain, in particular, the machinery segment. So, there is a need for pharma equipment that can meet the demands of multi-product manufacturing, high-speed applications, minimal operator intervention, compatibility with high-end plant automation, etc.

Besides, the need to comply with stringent regulatory norms is adding to this drive. For example, recent regulations require pharma machines to be able to check for critical product parameters in the process rather than with sampling ie, to be compliant with Process Analytical Techniques (PAT). Adopting/complying with the Quality By Design (QBD) is another requirement, among others.

As a matter of fact, pharma machinery as a segment has evolved from being standard single-station compression to multi-station and from mini to mega press. Moreover, with the aid of engineering excellence and cutting-edge technology these machinery are being upgraded to yield better output.

As the technology further develops, solid dosage forms machinery are likely to be more user-friendly, more advanced & more efficient in the time to come. Also, with the focus shifting to more potent molecules and even towards biotechnology,

‘containment systems’ seem to be the technology of the future, sooner than later. For more on this, turn to the ‘Cover Story’.

Now, let’s look at another key aspect of the pharma value chain, without which there is a constant risk of damage to drugs during transit due to exposure to variable temperatures, improper handling, exposure to sunlight and oxidation, etc. You guessed it right; it is pharma logistics, especially the cold chain part of it.

However, the current cold-storage capacity in the country is grossly inadequate, and in line with a positive future outlook for the pharmaceutical industry, it is high time to scale up and develop integrated cold chain facilities across the country. The ‘Special Feature’ highlights some of the emerging technologies that are being utilised for smooth and efficient deployment of supply chain for the pharma space.

Wondering about the impact of this year’s Budget announcement of increased weighted deduction on in-house R&D? Well, the industry needs to leverage such positive steps in its quest to develop India’s first blockbuster molecule. The ‘Roundtable’ engages some of the industry experts to gauge their views on this dream. Read on…

Manas R [email protected]

Modern Pharmaceuticals May 20108

CONTENTS

LEADERS SPEAK“India needs to move beyond the price advantage”...says Devinder Pal, Founder President & CEO, Catalyst Pharma Consulting 22ROUNDTABLEIncreased weighted deduction on R&D: Is it sufficient for India’s first blockbuster? 26PROFILEActis Biologics Pvt Ltd: Formulating affordable therapeutics 30COVER STORYSolid dosage forms machinery: Integrating precision with speed 34SPECIAL FEATURECold chain logistics: Calling for progressive development 40DRUG DISCOVERYRemodelling medicinal products: Offering multiple therapeutic options

Dr A K Batham

Executive Director, ACEAS Clinical Research 44MARKETINGRendering personalised services: Novel approach to bolster drug promotion Dr Rajan T D Pharma Consultant and Practising Dermatologist 47INDUSTRY INSIGHTSFuture of biosimilars: Opportunities galore 51

FEATURES3434

REGULAR SECTIONSEditorial ............................................................... 7

National News................................................... 10

World News....................................................... 14

Techno Trends................................................... 20

Events Calendar ................................................ 55

Fresh Arrivals .................................................... 58

Product Update................................................. 60

Product Inquiry ................................................ 67

Advertisement Inquiry ..................................... 69

Product Index ................................................... 71

Advertisers’ List ................................................. 72

Cover photo courtesy: Drugmaker’s Laboratories, Inc

Note: $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

Highlights of Next IssueCover Story : Pharma Retailing Special Feature : Alternative Medicines

2626

2222

4444

3030

4747

2010May

4040

Courtesy: GBI Research


N AT I O N A L N E W S

STAKE ACQUISITION

BBPL becomes wholly owned subsidiary of BioconBiocon SA, a subsidiary of Biocon Ltd has entered into a definitive agreement to acquire the 49 per cent equity stake held by CIMAB SA in Biocon Biopharmaceuticals Private Ltd (BBPL). BBPL will now become a wholly owned subsidiary of Biocon Ltd.

This move allows the two partners Biocon and CIMAB to focus on the joint development of novel biologics led by a most promising programme T1h (anti-CD6 monoclonal antibody), which has recently entered phase III clinical trials for Psoriasis.

BBPL, a joint venture between Biocon and CIMAB was established to provide manufacturing support to a range of biopharmaceuticals to be jointly developed by the two partners. This partnership has already resulted in the successful launch of India’s first novel monoclonal antibody BIOMAb™, for the treatment of head & neck cancer. Biocon has also established ERYPRO™ (Erythropoietin), as a major brand in India.

BBPL will continue to provide manufacturing support for all partnered programmes between CIMAB and Biocon. Speaking on the development, Kiran Mazumdar-Shaw, CMD, Biocon Group, said, “This move opens a new

chapter in our valuable partnership with CIMAB. We see T1h as a unique global opportunity that has the potential of being a ‘best in class’ therapy for a range of auto-immune diseases like psoriasis, rheumatoid arthritis, multiple sclerosis and diabetes.”

NEW FACILITY

Bafna Pharma inaugurates R&D facilityBafna Pharmaceuticals recently inaugurated its Research and Development–Formulations (FR&D) facility at Grantlyon, Chennai. Mike Nithavrianakis, British Deputy High Commissioner of Southern India, inaugurated the facility. The company has a 100 per cent export-oriented unit at Madhavaram on the outskirts of Chennai.

Bafna Mahaveer Chand, CMD, Bafna Pharmaceuticals, said, “The FR&D is a

state-of-the art facility for formulation and analytical development. It has been designed and equipped to meet the stringent international standards. Through this Rs 12-crore facility, Bafna Pharma will file dossiers for the growing US, UK and European & RoW markets.”

Bafna Pharma has established two units in Chennai and is involved in contract manufacturing.

“More business opportunities were available in South India, especially in pharmaceuticals. UK was

establishing a close relationship with experienced & disciplined investors and Bafna Pharmeucauticals had set an example in this regard,” observed Nithavrianakis.

Kiran Mazumdar-Shaw

Mike Nithavrianakis

OUTSOURCING

Positive growth for pharma outsourcing market

The pharma outsourcing industry in India is anticipated to reach a Compounded Annual Growth Rate (CAGR) of about 34 per cent in 2010-13, owing to growing prospects of the global generics market, according

to RNCOS’ latest research report ‘Indian Healthcare - New Avenues for Growth’.

In coming years, the industry may continue to escalate backed by growing prospects of the global generics market. The demand for pharma outsourcing will surge, as drugs worth billions of dollars are going off-patent in the next few years. The study revealed that the growth in the pharma outsourcing industry will also be driven by the vast pool of healthcare professionals, who can be recruited at a fraction of costs in India compared to the costs in the West.

Further, low production cost, strong reverse engineering skills and

large number of USFDA-approved manufacturing plants, with a large number of Indian companies upgrading their facilities, will enable India to become a global contract manufacturing hub in near future. Low costs of clinical trials and large patient pool present in the country will pave the way for contract research outsourcing in the country.

Besides this, RNCOS has done extensive research and prudent analysis of the Indian healthcare market to understand the factors that will continue to push the market growth in future.



PATENTS

Drug patents in India help promote innovation

Ranjit Shahani, President, Organisation of Pharmaceutical Producers of India has released the statement on Intellectual Property Day, concerning the effect drug patent protection is having on innovations in India.

According to the statement, emotion tends to over-ride facts when

it comes to patents and patients’ concerns. Consider the fears stoked when India joined the World Trade Organization in 1995. Many feared drug prices could rise, access to medicines could be reduced and many Indian pharmaceutical companies could close down.

Fifteen years later, these fears have proved unfounded. Drugs in each category are available at multiple price points, accessibility is clearly independent of patents. Indian companies have become multinationals and entered foreign markets worldwide.

When India reinstated patent protection via Intellectual Property Rights (IPR) reforms, many feared

this would lead to decreased access to medicine and delayed entry of generic medicines. Despite the lack of pharmaceutical patents in India for 35 years and some of the lowest prices for medicine in the world, access to medicine in India remained among the lowest in developing nations. In other words, patents have little to do with the ability to access medicines.

While many try to point fingers at drug patents and IPR protection, the lack of healthcare financing and particularly health insurance are the real culprits. Limiting the types of innovations, which receive patent protection, as India currently does, will not improve the health of people of India; added the statement.

HR POLICIES

Pharma industry in need of trained professionalsThe Rs 75,000-crore Indian pharmaceutical industry — comprising both domestic & transnational companies — is scrambling for talent, as it puts in place aggressive expansion plans, primarily in rural India and small towns.

Dr Reddy’s, Elder Pharma and Mankind Pharma, each plan to hire 1,000 people in their marketing and

sales force this year, while Lupin wants to add another 800. Prabir Jha, Global Chief-HR, Dr Reddy’s, said that the company had recruited 2,300 people last year.

Indian arm of British giant GlaxoSmithKline (GSK) and US-based Abbott are also expected to hire aggressively. In February 2010, GSK India had said it would recruit about 300 people this year.

Demand is forcing this expansion drive, said Ranjit Kapadia, VP -

Institutional Sales, HDFC Securities . From an annual growth rate of 10-14 per cent a few years ago, the local drug market is growing at over 17 per cent. “So, at even 15 per cent growth, a whopping Rs 10,000 crore market will be created next year,” he added.

NOVEL TECHNOLOGY

Atlas Copco presents its energy-efficient screw technology blowers Atlas Copco recently announced its new and proven energy-efficient technology-ZS screw blower- for air blowing applications. Screw technology on an average is 30 per cent more energy-efficient compared to the lobe technology. Atlas Copco is convinced that the lobe technology, widely used at present, no longer meets the needs of today’s low carbon economy.

Industries and applications such as wastewater treatment, pneumatic conveying, power generation, food &

beverage, pharmaceuticals, chemicals, pulp & paper, textiles, cement, and general manufacturing will highly benefit from energy savings through replacing the conventional lobe with the leading screw technology.

Stephan Kuhn, President-Compressor Technique Business Area, Atlas Copco, said, “Atlas Copco continuously innovates to ensure sustainable productivity for its customers. They will greatly benefit from the average 30 per cent energy saving achieved from our leading-edge screw technology compared to conventional lobe-type blowers.”

Chris Lybaert, President-Oil-free Air Division, Atlas Copco, added, “Energy consumption typically represents 80 per cent of the lifecycle costs of a blower. By introducing screw technology to our air blower range, we now offer a complete product portfolio of compressors and blowers for all applications.

Ranjit Shahani

Courtesy: www.aslis.com



INDUSTRY FORUM

Pharmalab organises technical seminar on barrier isolator technologyPharmalab, which recently tied-up with Switzerland based SKAN-AG, organised a technical seminar for the benefit of the Indian companies, as SKAN-AG was keen to share its experience and expertise on features, advantages and opportunities for barrier isolator technology for aseptic manufacturing processes with the Indian companies.

Volker Sigwarth, CEO, SKAN-AG and Thomas Huber, director-Sales, SKAN-AG presided over the seminar and informed the audience about isolator technology in comparison with traditional methods of clean room techniques with LAF & RABS and hydrogen peroxide (H2O2) decontamination.

The seminar received a warm response and its contents were highly appreciated by the audience with almost every participant taking back some valuable tips and experience

shared by the experts. SKAN-AG is known for its expertise in designing and manufacturing of isolators for aseptic processing of pharmaceutical products.

MERGERS

Fem Care merges with Dabur IndiaAs per a recent announcement by Dabur India Ltd, the Delhi high court has approved the merger of Fem Care Pharma and Dabur. Dabur had acquired 72.15 per cent in Fem Care in 2008 for Rs 2.03 billion in an all cash deal, followed by a 20 per cent open offer worth Rs 560 million.

“Besides giving Dabur a strong foothold in the skincare market with an established brand name FEM, this merger also offers us a platform to enter new product categories,” said P D Narang, Group Director, Dabur India.

Fem Care Pharma is a leading manufacturer of fairness bleach, hair removal creams and liquid soaps.

Volker Sigwarth addressing the audience

TRANSFER AGREEMENT

Orchid Chemicals completes business transfer to Hospira

Chennai-based Orchid Chemicals & Pharmaceuticals has completed

the sale and transfer of its generic injectable finished dosage business to Hospira Healthcare India Pvt Ltd, a wholly owned subsidiary of Hospira Inc, USA.

Orchid Chemicals & Hospira had signed a business transfer agreement last December to sell Orchid’s injectables business, the manufacturing complex and research & development facility at Irungattukottai for $ 400 million. Hospira, which has a 50:50 joint

venture with the Ahmedabad-based Zydus Cadilla for manufacture of oncological drugs, found Orchid Chemicals’ betalactam plant suitable, as it did not have a presence in that segment.

“Through the strategic supply arrangement with Hospira, Orchid would be ensuring long-term contractual active pharmaceutical ingredients (API) revenue streams,” said K Raghavendra Rao, managing director, Orchid Chemicals.

K Raghavendra Rao

APPOINTMENT

NAFDAC selects Silis Labs for quality control analysis

National Agency for Food & Drug Administration and Control-Nigeria

(NAFDAC) has appointed Silis Labs, Gujarat, as one of the approved quality control analysts in India. This operation is undertaken to sample, analyse, scrutinise and inspect all finished formulations & active pharmaceutical ingredients (API) being manufactured by Indian manufacturers and intended to be exported to Nigeria based on NAFDAC Registration certificates issued by the organisation.

NAFDAC has sent a letter regarding this issue to the Central Drugs Standard Control Organization.

Silis Labs partners with pharmaceutical companies, research facilities, academic institutions, contract pharmaceutical testing laboratories and Contract Research Organisations (CROs) to perform pharmaceutical studies, research projects, experimentation, laboratory testing and analysis.

Courtesy: www.thehumanresourcesteam.com

Courtesy: www.academicaffairs.cofc.edu


W O R L D N E W S

BIOECONOMY

Eurasian Biotechnology Federation established

The Eurasian Biotechnology Federation (EABF) was established at the recently

held second international EurasiaBio 2010 in Moscow, Russia, to boost the bioeconomy in Europe and Asia.

The members of the federation include Russian Biotechnology Society, Institute of Cell Biology (NAS of Ukraine), Federation of Asian Biotech Associations (India), Biotechnology Centre of Kazakhstan, Mongols Institute of Sciences and GH BioQuenta Consulting EU (Austria).

Dr B S Bajaj, Secretary General, Federation of Asian Biotech Associations,

said, “EABF aims to promote & support education, training, research, development, innovation, industry, funding, investments and business in biotechnology.”

To achieve its goal, EABF will facilitate a dialogue among scientists, industry, regulatory bodies and government authorities. The membership of EABF is open to all organisations, companies & individuals involved in biotechnology and institutional members from Eurasian countries.

CLINICAL TRIALS

PLx Pharma’s PL 2200 Aspirin successful in phase II trial

PLx Pharma recently announced positive results from the company’s phase II endoscopic study of PL 2200 Aspirin. During its phase II trial, the drug showed considerable decrease in the risk of ulcers and erosions compared with immediate release aspirin.

The drug formulation, when taken once a day for seven days, reduced the incidence of gastric & duodenal ulcers by 71 per cent and that of combined erosions & ulcers by 47.4 per cent compared to immediate release over-the-counter aspirin.

Byron Cryer, MD, University of Texas Southwestern Medical School & VA North Texas Health Care System as well as lead investigator of the trial, said, “This trial conducted in 201 healthy adults aged

50-75 years, who are at risk for cardiovascular disease & stomach injury, demonstrated that aspirin, even with short-term exposure, induced a surprisingly high incidence of ulceration, and this damage could be significantly decreased with PL2200 Aspirin.”

REGULATORY APPROVAL

EU approves Tarceva for treatment of advanced lung cancer

As per a recent statement by Roche, an international partner of OSI Pharmaceuticals

Inc, the European Committee for Medicinal Products for Human Use (CHMP) has given positive opinion for using Tarceva® (erlotinib) as a maintenance therapy for patients with advanced Non-Small-Cell Lung Cancer (NSCLC) and stable disease (cancer remains largely unchanged) after initial chemotherapy. The positive opinion of CHMP clears the way for European Union (EU) approval and indicates that such patients may soon benefit from earlier treatment with Tarceva.

The EU approval was based on data obtained from the pivotal phase III SATURN study.

Explaining the advantage of using Tarceva, Professor Federico Cappuzzo, Head-Oncology Unit, Livorno Hospital, Italy, and Principal Investigator of the SATURN trial, said, “By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we can help more patients live longer without their disease becoming worse.”

AGREEMENT

Nycomed & Merck partner to co-promote Daxas

Nycomed and Merck & Co Incorporated have announced their entry into a co-promotion agreement for Canada & certain European countries for commercialisation of Daxas.

The drug formulation, which contains the active pharmaceutical ingredient roflumilast, is an

investigational once-daily tablet for patients with Chronic Obstructive Pulmonary Disease (COPD).

Also, the two companies have signed an exclusive distribution agreement for the commercialisation of Daxas® in the UK.

Speaking on the agreement, Kevin Ali, Senior Vice President & General Manager-Bone, Respiratory, Immunology and Dermatology franchise, Merck & Co, said, “This

builds upon Merck’s leadership in the asthama & allergy marketplace and positions the company to leverage our well-trained sales force to target the rapidly growing unmet medical needs of COPD.”

Courtesy: www.merrimack.edu


W O R L D N E W S

ONLINE COMMUNITY

Water launches social media forum

Waters Corporation has launched its latest online community featuring exclusive Waters® Empower™ Software and NuGenesis® Scientific Data Management System (SDMS) resources

& access to Waters’ experts & shared user experiences.

The development of Waters social networking communities is part of a growing trend in science industries that leverages peer-to-peer knowledge to resolve difficult challenges.

Speaking about the new community, Marcia Rabb, Senior Product Marketing Manager, Waters, said, “Our Informatics customers have been asking for a forum where they can easily access the latest information

about Waters software, share their experiences and learn from peers.” He further added, “In addition to targeted support materials and exclusive content only available in the community, members have benefitted from the robust discussions. To date, some of the most popular topics discussed among members include data sharing between colleagues around the world, Window 7 support for Empower and SDMS and validation requirements for chromatography data systems.“

EXPANSION

Bilcare Global Clinical Supplies to open unitin Wales Bilcare Global Clinical Supplies, a leading single-source provider of clinical trial services spread across continents will open its second unit at the Elvicta Industrial Estate, Crickhowell, Wales, UK.

The new unit will add 30,000 sq ft and double the company’s European capacity to package, store and distribute clinical

supplies in ambient, refrigerated and frozen conditions.

Mohan Bhandari, Chairman & Managing Director, Bilcare Ltd, said, “With the drug discovery programme leading to potential new drugs becoming more complex, the need to clinically test drug efficacy and safety in diverse population groups across multiple geographic regions is becoming a crucial necessity.” Moreover, he added that the company is now geared to cater to ever-challenging requirements of its global customers, especially those parts of the UK

‘cluster’ of companies, looking to roll out their clinical trials effectively in Europe.

Bilcare Global Clinical Supplies serves the Americas, Europe and Asia with clinical trial materials support, services & complete project management.

CLINICAL RESEARCH

Icagen provides update on ICA-105665

Icagen, Inc recently provided an update on clinical development plans for ICA-105665,

the company’s novel drug candidate for the treatment of epilepsy and pain. The drug had demonstrated positive results in phase IIa study in patients with photosensitive epilepsy; and, hence, the US Food & Drug Administration (USFDA) has approved the proposed further trial, using a higher dose.

In phase IIa studies, a single dose of 400 mg ICA-105665 was administered to four patients of which two showed positive response.

Based upon the efficacy demonstrated in the recent study of photosensitive epilepsy patients, coupled with a favourable clinical safety profile, consistent pharmacokinetics and the lack of a maximal tolerated dose in all clinical studies to date, the company proposed, and the FDA approved, a study of up to two additional cohorts of photosensitive epilepsy patients at higher doses of ICA-105665.

APPROVAL

Japan approves Takeda’s NDA for Nesina

Pharmaceutical Product Development (PPD) has announced that Takeda Pharmaceutical Company Ltd’s New Drug Application (NDA) for Nesina has been approved by the Japanese Ministry of Health, Labour and Welfare.

This drug formulation was developed by Takeda and PPD’s compound partnering division. Speaking on the approval, Fred Eshelman, Executive Chairman, PPD, said, “This approval is an important milestone and confirms our strategy of partnering with pharmaceutical companies such as Takeda to bring forth new therapies to market.”

Nesina contains the active pharmaceutical ingredient alogliptin, and is a highly selective DPP-4 inhibitor indicated for treatment of type II diabetes.


W O R L D N E W S

VACCINES

Archivel Farma’s TB Vaccine may reduce treatment time

Archivel Farma’s, breakthrough treatment for tuberculosis (TB) will shortly start phase II clinical trials.

The treatment uses the company’s unique combination of novel therapeutic vaccine called RUTI® in conjunction with an antibiotic. This reduces drastically the treatment time from nine months to one month, decreasing side effects & healthcare costs, and preventing re-infection during the eradication process. The vaccine is expected to be commercially available by 2015.

Archivel’s novel, two-pronged approach combines a one-month

course of antibiotic to eliminatethe bacteria in the replicating stage and two injections of the RUTI vaccine that stimulates the body’s own immune system to fight the bacteria. Besides reducing the treatment time, this combination approach is easier to manage, less expensive and more effective. Also, the company estimates the new treatment costs approximately half of the old treatment.

DISCOVERY

Important control mechanism of autoimmune diseases discoveredResearchers at the Swedish medical university, Karolinska Institutet (KI), have found a new control mechanism in human immune system. The discovery is of potential significance to the treatment of diseases like Multiple Sclerosis (MS), rheumatoid arthritis and Systemic Lupus Erythematosus (SLE).

Dr Mikael Karlsson, Associate Professor, Department of Medicine, Karolinska Institutet, Solna, said, “As we have begun to understand the regulatory mechanisms involved in these autoimmune diseases, we hope to find new treatments.”

Patients with SLE and other autoimmune diseases have low levels of Natural Killer T (NKT) cells. Previously, the role of these cells in origin and development of the disease was not known; but the research group at

KI has shown that this deficiency is a contributory pathogenic factor.

“We have shown that NKT cells can regulate activation of B cells against healthy tissue, and lack of NKT cells results in greater misguided B cell activation,” said Dr Karlsson.

FDA APPROVAL

FDA grants orphan drug designation for Prochymal for use in type I diabetes mellitus

Osiris Therapeutics has been granted orphan drug designation by the US

Food and Drug Administration (USFDA) for Prochymal as a treatment for type I diabetes mellitus.

This designation provides a market exclusivity for a maximum of seven years after approval, eliminates FDA filing and registration fees and provides tax incentives for about 50 per cent of the clinical development costs.

Osiris also holds orphan drug designation for Prochymal used in

the treatment of graft versus host disease (GvHD).

Prochymal, a formulation of adult mesenchymal stem cells (MSC) designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration and preventing scar formation, is currently being evaluated in a double-blind, placebo-controlled phase II clinical trial for type I diabetes.

RESEARCH

Pieris announces positive preclinical data on c-Met Anticalin Drug Program Pieris AG announced preclinical data for its proprietary PRS-110 Anticalin(R) compound, which targets the c-Met receptor, showing a dose-dependant decline

in tumor growth in a xenograft mouse model.

The results provide an indication that an Anticalin approach to antagonising the c-Met pathway may be of significant therapeutic value in treating cancer. A broad body of research has shown that c-Met plays a role in several mechanisms by which cancer cells proliferate and escape

programmed cell death. Pieris has developed its anti-c-Met PRS-110 compound by using its proprietary Anticalin technology.

Courtesy: www.upload.wikimedia.org


T E C H N O T R E N D S

Absorption Systems installs LTQ Orbitrap XL to improve drug metabolism serviceAbsorption Systems recently installed the LTQ Orbitrap XL hybrid fourier transform mass spectrometer, developed by Thermo Scientific, into its drug metabolism programme.

The product is based on the fast & sensitive LTQ XL™ linear ion-trap mass spectrometer and the Orbitrap mass analyser. This combination produces an instrument with capabilities for metabolite identification (ID), while retaining sensitivity and dynamic range.

It can also quantify a parent drug in complex biological matrices and automatically detect plausible metabolites as well as acquire MS(n) data required for structural elucidation.

Metabolite ID is an important element of Absorption Systems’ drug metabolism programme. It helps researchers select appropriate non-clinical toxicity species based on exposure to major human metabolites.

“Absorption Systems consistently uses the most advanced, proven technologies available to support customers’ drug metabolism and other absorption, distribution, metabolism, excretion & toxicity (ADMET) programmes. The LTQ Orbitrap XL provides our clients with superior precision, sensitivity and performance when conducting metabolite ID,” said Patrick M Dentinger, President & CEO, Absorption Systems.

Penwest Pharmaceuticals Co recently signed a drug development and commercialisation agreement with Alvogen Inc, the US-based pharmaceutical manufacturer of complex generic products. Under the agreement, the two companies would identify and select up to five compounds for generic development. TIMERx technology from Penwest may be used for each compound selected.

Penwest will formulate these compounds and receive milestone & royalty payments linked to development of each compound. Further, Alvogen will take up manufacturing, clinical trials & regulatory filings for all formulations, and commercialise the products worldwide.

Jennifer L Good, President & CEO, Penwest Pharmaceuticals, said, “This multi-drug, multi-national agreement allows Penwest to leverage its drug delivery technology for the formulation of generic drugs - an important segment of the market for extended release technology. TIMERx technology had its beginning in generics, with the development of the first generic-Pfizer’s Procardia XL- formulated using the Alza Oros technology. We are pleased to leverage this valuable advantage of TIMERx in the development of difficult-to-formulate

generic products with the expertise of the team from Alvogen.”

Penwest, Alvogen enter into a multi-drug generics agreement

New research identifies cellular target that may lead to breakthrough in skin drugs

Hunt Biosciences, Tissue Solutions sign collaborative agreementHunt Biosciences AS, the specialised biomarker discovery and validation company has signed a collaboration agreement with Tissue Solutions, an international supplier of biological samples for the pharmaceutical and diagnostics industry.

The aim of the collaboration is to promote the value of an unique study by Hunt, which for the past 25 years has collected blood samples from the general population of the Nord-Trøndelag region in mid-Norway along with detailed phonotype and environmental data to accelerate biomarker discovery & validation.

“We believe that the unique combination of biomedical and phenotypic information that has been collected over the past 25 years from a general population rather than a specific disease cohort can help accelerate biomarker discovery and validation. Furthermore, working from a general population base gives core strength to a whole range of key public health areas such as cancer, cardiovascular disease, diabetes, obstructive lung disease, osteoporosis and mental health. Through this collaboration we aim to significantly increase our pharma and diagnostic industry customer base,” said Per Foss, CEO, Hunt Biosciences.

A recent research conducted at the Children’s Hospital, Boston, identified a small cellular channel regulating skin & hair growth, which could be targeted with small-molecule drugs for potentially treating various skin conditions, as well as thinning hair or unwanted hair growth.

The study led by Dr David Clapham of Children’s Hospital Boston and Dr Haoxing Xu from the University of Michigan found that TRPV3, a protein mainly found in the skin ‘supercharges’ the TGF-alpha/EGFR pathway, which helps regulate growth & specialisation of cells in the epidermis.

In tests conducted on mice, lack of TRPV3 resulted in mice having a thinner outer skin layer with a dry, scaly texture, appearing as a less intact, more permeable barrier.

Experiments have shown that EGFR activates the ion channel TRPV3, causing an influx of calcium that triggers many signalling pathways inside the cell including the one stimulating release of TGF-alpha.

Dr Clapham said, “Drugs stimulating TRPV3 activity may offer a new way of treating multiple skin conditions

like burns, bed sores, eczema, psoriasis, itch, fungal infections and oral mucositis. It might be possible to develop cosmetic treatments that make the skin more firm, pliable and youthful.”

Courtesy: Covance, IncCourtesy: www3.imperial.ac.uk


T E C H N O T R E N D S

EyeGate Pharma, GSK enter research collaboration on ocular delivery of drugsEyeGate Pharma, a specialty pharmaceutical company focussing on ophthalmology has entered into research collaboration with GlaxoSmithKline (GSK) to evaluate the delivery of several GSK therapies to the anterior and posterior tissues of the eye using the EyeGate II delivery system.

Stephen From, President & CEO, EyeGate Pharma, said, “EyeGate has developed a unique, non-invasive system that delivers therapeutics for ocular diseases. Our research collaboration with GSK seeks to demonstrate the ability of EyeGate’s proprietary technology in delivering GSK molecules targeted to areas of the eye.”

The EyeGate II delivery system uses iontophoresis technology to deliver therapeutics into the eye. A low-level of electrical current ionises a drug and modifies the permeability of cells, allowing the therapeutic to be delivered through tissues to targeted areas.

EyeGate believes this improves alternative drug delivery systems like ophthalmic drops and intra-vitreal injections by providing better absorption & reduced risk.

EyeGate has conducted multiple controlled clinical trials to assess the safety & efficacy of iontophoresis technology.

DSM Biologics, a business unit of DSM Pharmaceutical products, has announced an agreement for the acquisition of the assets & associated business of the Rhobust™ technology from Upfront Chromatography A/S (Denmark) for pharmaceutical and other applications.

With the acquisition, DSM Biologics will gain all rights for the commercialisation of this technology in various fields, including the pharma industry. The new technology will lead to further innovation in the downstream processing for manufacturing recombinant proteins and antibodies. DSM Biologics will continue to support all existing clients for this technology. The parties have agreed not to disclose financial details.

The Rhobust™ technology has proven its ability to perform with high titre and high-density cell culture processes. Compared to a conventional harvest approach, the number of unit operations have reduced. The cells are separated in one step while capturing the protein/antibody of interest. In the expanded bed adsorption chromatography (EBA), the cell suspension passes through the column and the product is adsorbed either on Protein A or on mixed mode ligand beads. This leads to less handling

and shorter process times.

Antares Pharma, Uman Pharma partner for VIBEX™ MTXAntares Pharma, Inc, a specialist in self-injection drug delivery technology and Canadian injectables specialist, Uman Pharma have joined to develop Antares’ VIBEX™ MTX. Under the agreement, Antares and Uman will invest jointly to develop & commercialise VIBEX™ MTX, Antares’ novel pressure-assisted, injection device, containing methotrexate (MTX) for rheumatoid arthritis and related autoimmune conditions in the US & Canada.

Antares will lead the clinical development programme, FDA regulatory submissions and retain rights to commercialise the product outside Canada. Further, Uman will conduct formulation development & manufacturing to support registration of the product MTX and supply methotrexate in pre-filled syringes to Antares for the US market. The companies intend to work together to commercialise the product in other territories.

“Our market research with physicians shows that most would frequently use methotrexate by the parenteral route, accelerating market growth, if provided with a simple-to-use and secure system that enables patients to reliably and

comfortably self-inject the drug. We believe that physicians and patients will welcome our VIBEX™ injection system to administer parenteral methotrexate,” said Dr Paul K Wotton, President & CEO, Antares Pharma Inc.

Genzyme and Arecor collaborate to develop protein therapeuticsGenzyme Corporation and Arecor Ltd recently signed an agreement for extensive collaboration on developing advanced formulations for protein therapeutics. The companies have come together to develop stable, high strength formulations of labile biomolecules.

Arecor Ltd was established to provide formulation solutions to pharmaceutical and biotech companies developing drugs, vaccines, medical devices & diagnostics. Proteins & vaccines are usually fragile entities, and stability can have significant constraints in the development of new products and extending the use of existing products. Arecor has developed Arestat™, a patented set of tools for stabilisation, to enable the presentation of labile biologicals as stable aqueous formulations even at high concentrations or in situations where cold storage is not practical or desirable. It can also protect proteins from degradation due to ionising radiation, typically used in the sterilisation of medical devices.

Also, as a simple reformulation, Arestat™ can be readily incorporated into standard manufacturing practice, without covalent medication of the biological and using excipients approved for the route of delivery.

DSM Biologics to acquire Rhobust™ technology from Upfront Chromatography A/S

Courtesy: www.boston.com

EyeGate II delivery system

Courtesy: EyeGate Pharm

a

L E A D E R S S P E A K

“India needs to move beyond the price advantage”

…says Devinder Pal, Founder President & CEO,

Catalyst Pharma Consulting. A doyen of the

Indian pharmaceutical industry, he has over five

decades of experience in the pharma sector

and has served senior positions in some of the

global pharma firms, large Indian companies. A

well acknowledged and respected professional,

he has closely observed, participated as well as

contributed to the growth of the industry

in India from its infancy.

In this exclusive interview with

Rachita Jha, Pal shares his insights

on the changing dynamics of the

Indian pharma industry and its

growing global footprint…

Modern PharmaceuticalsModern Pharmaceuticals May 2010May 201022

Current status…The pharma industry in India has grown by leaps and bounds. The country today is an established giant in global pharma industry and ranks

third or fourth in terms of volume of production. With a growth rate of

12-14 per cent, the pharma sector is expected to reach $ 40 billion by 2015. Exports in this sector account for

8 billion and remain a major revenue generator, with growth rate expected to

continue at 20 per cent per annum. Today, even as the growth rate of exports is nearly

double that of domestic growth, there is a high possibility of a turnaround, only if the

unexplored markets are tapped in rural India. If the pharma companies build a comprehensive

plan & strategy to penetrate the rural areas as



well as smaller towns and cities, this industry will realise its true growth potential. An exponential increase in demand & production volume will be inevitable in future, witnessing a new growth story of the Indian pharma industry.

APIs in upswing trend…The API market in India continues to be in growth phase due to its major cost advantage. This segment has nearly 50 per cent price advantage when compared to that in developed countries. Overall, the scale of production volumes can be assessed from the fact that every second pill consumed in the world comes from India. In future, nearly 60 per cent of the growth will be driven by shift in income demographics and increase in medical infrastructure. The demographic data shows that a majority of the population in India consists of youth. Moreover, we have a combination of diseases including those prevalent in the affluent world as well as in the developing world. On one hand, the rural population is facing a discrete set of ailments, which have largely remained untouched by the healthcare segment. Tremendous opportunities lie here for the Indian pharma sector to expand its footprint within the domestic markets.

Tapping the rural markets…For the Indian pharma industry, villages and small towns remain the islands & oases of immense growth and opportunities, but pose numerous challenges. Today, the low penetration of pharma companies in these areas leave much to be achieved with respect to growth of Indian pharma sector. Moreover, considerable work needs to be done in health infrastructure available to meet the needs of low-income groups and rural populations.

Strengthening global position…Global big pharma companies have been advancing at a considerable pace. These companies are now coming under increasing pressures, as approvals by the US Food & Drug Administration (USFDA) for new drugs have reduced substantially. Also, there are growing concerns on safety & side effects of new drugs coupled with demand to reduce the costs, from the governments and the consumers. Increased safety factors have led to steep increase in the overall costs of products from these companies, which also need to balance the financial feasibility of new products.

The global big pharma is also in the middle of a crisis due to the impending expiry of patent protection of several blockbusters, besides tightening of regulatory standards and price pressure. This is a challenge that the global pharma industry has to overcome. Hence, they are approaching companies from countries like India, in order to establish their manufacturing base and partner with them to reduce costs in order to be able to continue the growth of their business. These and other alternative arrangements of partnerships & collaboration have given an impetus to the growth of the Indian pharma sector. In the near future, many other good opportunities will be open for India.

India has a share of about 23 per cent in the total Abbreviated New Drug Application (ANDA) approvals and 48 per cent of the

Drug Master Filing (DMF) with the USFDA, according to a recent KPMG report.

Multiple standards…The cost of pharma products is lower in India compared to that in the developed world. This can be considered as a positive as well as a negative sign. A major drawback of this cost difference is that it results in multiple standards across the globe for products produced in India. The Indian pharma industry is adopting multiple standards of quality, which may vary for exports to a developed country, developing country and domestic market. These differences are leading to entry of sub-standard products into the market, as the overall quality standards are not visible in the final product. One cannot gauge the overall manufacturing process that was adopted in the production of a particular drug. This results in all products appearing deceptively identical. This practice remains a major cause of concern.

New molecules…With 49 major pharma products scheduled to go off patent by 2013, there is an urgent need to address this gap in the market. In terms of value, the next 4-5 years will witness drugs worth nearly $ 65-70 billion going off patent, thus opening tremendous opportunities for India to tap these markets. With respect to costs, nearly 70 per cent of the new molecules discovered and released in the market do not recover their cost

The defining question for pharma companies today remains to invest in development of new molecules and deliver them at affordable prices in the end-markets. This can be done only by differential pricing based on the affordability.



of discovery. In 1996, discovery of a new drug cost $ 300 million, while today it is over $ 1 billion. Hence, the funding for this huge cost of discovery and challenges faced in recovery of costs from discovery of a new molecule is a big obstacle for pharma companies.

Until last 5-10 years, the Indian pharma sector lacked a strong R&D segment. However, in recent times, with the entry of major industry players in the drug discovery market, the trend to invest in research and development of new molecules has gained pace. While lack of adequate funds for R&D in the pharma industry in India is a disadvantage, the low cost of research compared with that in the rest of the world makes India a manufacturing hub for many global pharma companies.

There is a symbiotic relationship between the Indian and global pharma companies with respect to drug discovery. In the partnership, while the global company saves considerable cost for research, the Indian counterpart gains access to the global value chain and recovers a substantial share of its R&D investments. Thus, the defining question for pharma companies today remains investing in new molecules and delivering them at affordable prices in the markets.

Technology potential…Today, technology has become a necessity for the Indian pharma industry for addressing the problem of counterfeit drugs. While considering the track & trace of products, there is a need to follow an e-pedigree of the product, all of which can be done only by the use of technology. This necessity has led to many inventions in advanced technology tools as the needs arise to cater to new problems. Automation has been a

major success in this field. It has also helped companies to seamlessly scale-up production lines and realise huge market expansion plans, thus popularising the adoption and appreciation of technology in the Indian pharma sector. Technology is a tool that can help companies move ahead at various levels in scale and operations. Novel drug discovery has also been a major spin-off for the advancements in technology. There are new drugs with an improved efficacy pattern that eliminates the need for regular doses of the same drug throughout

the day. This is found to reduce toxicity, increase the efficacy and assist in compliance of dosage prescription. This field holds immense potential for growth in the pharma industry.

Generics landscape in India…India has long been a marketing hub for branded generics products. China has also emerged as a preferred destination for several global manufacturers, as it has a good manufacturing competency, and is aware of Good Manufacturing Practices (GMPs). It also successfully complies with the GMPs. China is making strong efforts to present itself as a favourable business destination for the global pharma

industry, as India holds the price advantage. Nevertheless, with increasing competition in the global pharma business and many new drugs going off patent in the next few years, India needs to move beyond the price advantage and focus on the parallel need to invest in novel R&D.

The US is the largest generics market, with 28 per cent of global generics sales. This is expected to touch $ 94 billion by 2010, according to a recent research report. Increased price erosion and market saturation in the US, EU and Asia-Pacific countries forced Indian pharma majors to look at Japan, which is the world’s second larges market for generics after the US. Companies plan to benefit from the lucrative generics market as a logical progression in their international foray.

Future outlook…The Indian pharma companies are quite upbeat due to the cost advantage they have. Even as these companies take advantage of the current opportunities available in the global markets, they should be cautious that cost advantage has a shelf-life. Therefore, the Indian pharma industry should rely not only on the cost advantage but also climb up the value chain. Unless the companies make progress in the value chain, their success in the global pharma markets may be short-lived.

The global mergers in the pharma industry were valued at $ 166 billion in Q1 of 2009. This was more than 10 times that of deals announced in the first quarter of last year and well over the $ 114 billion in deals announced in 2008. Thus, the future clearly spells success for Indian pharma companies to make the best of an upbeat global business environment.

If the pharma

companies build a

comprehensive plan &

strategy to penetrate

the rural areas as well

as smaller towns and

cities, this industry will

realise its true growth

potential

Modern

Pharm

aceuticals

(M

ay-1

0)

Insert

24-A

Modern

Pharm

aceutic

als

(May-1

0)

Insert

24-B


ROUNDTABLE

Research in India has always been more development driven rather than innovation driven. Though a leading player in generics, the country still awaits its first New Chemical Entity (NCE). The scenario is nevertheless changing in recent times, as increasing numbers of Indian companies today are focussing on innovative research. Even the government support for the research is visible in the form of increased weighted deduction on in-house R&D announced in the recent Budget. With these positive developments, the first blockbuster molecule from India might not be a distant vision. Kavita Tate-Nadkarni speaks to some of the industry experts to know their views on whether the efforts in R&D by the industry and the government are enough to fulfill this dream.

Increased weighted deduction on R&D

Is it sufficient for India’s first blockbuster?

Sanjeev SaxenaChairman & Chief Promoter, Actis Biologics Group of Companies

In the current scenario, it is challenging for India to come

out with a blockbuster drug at least in near future. Reason

for the same is that most investors are looking for quick

returns, and hence are not investing too much into R&D. Most investments are going into

CRO/CRAM models, which allow for drugs to be developed for other companies. Further, the government is making tremendous efforts to help with various funding schemes like Small Business Innovation Research Initiative (SBIRI), Biotechnology Industry Partnership Programme (BIPP), etc. Notably, most of these funds are directed at institutions (not the industry), which work only on R&D and not commercialisation. Startup firms focussing on R&D, which do not have sufficient revenues, become hard pressed for cash and are unable to hire quality manpower to work on

new & promising drugs. Also, it is important to note that it takes 12 years from discovery to launch of a product and most companies are still in the discovery stage. We have to wait and watch. However, companies like Actis Biologics may change this soon and help the investment community look at this sector in a better light. We may see a lot more blockbusters hit the market then.

Increased weighted deduction on in-house R&D is interesting but not enough. How many such companies exist which are working on New Biological Entities (NBEs), anti-sense or gene therapy? Most such companies are working on biosimilars. While we will see Indian companies taking advantage of the increased weighted deduction for in-house R&D, no innovative molecule will be launched in near future.

R&D firms need funding, which is out of their control and more in the hands of the government & investors. They need to conduct more basic research and launch new molecules, which will set them apart from their competitors worldwide. They also need to understand the various technologies available worldwide and consider in-licensing & developing them if they are promising.


Vinaya K DubeyDirector - Sales & Marketing, BI Biotech IndiaThe Indian pharmaceutical industry has grown at a healthy annual rate of

11-12 per cent in the last few years, with primary drivers for

this growth being the increasing share of generics in developed

markets and opportunity in Contract Research & Manufacturing Services (CRAMS). The industry has also remained largely immune to the

global slowdown, showing India’s potential to become a global pharma hub in future.

Increase in weighted deduction by the government on expenditure incurred on in-house R&D will further encourage spending by pharmaceutical and biotechnology companies on research for New Chemical Entities (NCEs), New Drug Delivery Systems (NDDS), etc conducted in-house or outsourced to third parties like national laboratories and research

institutions. However, the impact on bulk drug manufacturers would depend on their ability to pass on the increase to domestic clients.

A blockbuster molecule from India seems a distant scenario but is inevitable. India has a strong base of research scientists and other research professionals. Also, the cost of carrying out R&D activities in India is an advantage, along with other aspects like scientific talent, patent protection, and a large patient pool, most of whom have not been exposed to advanced medical care.

One of the biggest challenges faced by the country on this front is Venture Capital (VC) funding, which is limited. Most venture capitalists are unwilling to invest in R&D, but fund companies whose products and markets are clearly identified or commercialisation of technologies already developed.

Collaborative drug discovery and development deals with innovator companies can pave the way for Indian pharma companies. These collaborative services enable knowledge sharing for running long-term R&D projects and utilise process methodologies that would otherwise take years to develop.

ROUNDTABLE

Dipta ChaudhuryProgram Manager - South Asia & Middle East, Pharma& Biotech Practice, Frost & Sullivan

Government incentives like tax benefit to Research &

Development (R&D) institutions have spurred several Indian

pharma companies to increase their focus on research, apart from drug

development for generics. Blockbuster molecules are difficult to develop. However, with an increase in the number of companies conducting research in India and a subsequent increase in the potential NCE molecules, the possibility of developing a blockbuster has increased.

The momentary focus of Indian pharma and biotech industry is to develop an NCE, which will position India on the international map for drug discovery, rather than just a blockbuster molecule. The government has increased the support to ensure that companies are working towards developing NCE molecules. As a result, collaborations have increased between Indian companies and international originator firms towards joint development of molecules for the global market. The tax benefits have helped these collaborations use Indian R&D facilities as the infrastructure base for research initiatives.

The increased weighted deduction provides a real and tangible benefit towards drug discovery research, and has been used by many pharma companies over the past few years. This is a direct message from the government to pharma companies to increase their contribution to R&D. However, the government also needs to increase support to other aspects of R&D, which will spur drug discovery research, including incentives, which reduce cost of conducting research in India, incentives to scientists, stronger patent protection of discovered products, etc.

Indian R&D is still at a nascent stage. The companies, which presently conduct discovery R&D in India are still importing capabilities to manage and conduct their drug discovery at later stages from experienced international companies, through joint ventures or out licensing of molecules. Indian companies should attempt to create a technological pool where they can share their basic infrastructure and research methodologies, which can help the whole group as well as reduce the learning curve for each company individually. Such a pool can develop securitised software, which can help in data storage and sharing of relevant drug discovery data with each other or within different R&D centers of a company, develop inexpensive Indian models for research at pre-clinical stages, share documentation work required for Indian & global submissions of the findings, etc.


ROUNDTABLE

Vijay ChandruChairman & CEO, Strand Life

Sciences; and President, Association of Biotechnology Led Enterprises (ABLE)

The weighted deduction on R&D can have a

good effect within larger profitable companies so as to

encourage spending on R&D. However, blockbuster molecules/

therapeutics has little chance of success for even the capital-rich global pharmaceutical companies.

Indian companies do not pay enough attention over innovation. This is because innovative drug development

requires genuine risk capital. The lifecycle of a new drug before it is introduced in the market is approximately 8-10 years and the company has to invest heavily into research. This is not possible for a majority of Indian biotechnology companies, as they are unable to spend enough money for such a long duration. Thus, despite having the technology potential, it is extremely challenging for an Indian company to develop its own blockbuster molecule.

The focus area of research today is mostly biosimilars and generics. India has the capability to be innovation-driven, with the presence of an excellent scientific pool & experienced research personnel. However, the biggest hurdle in the way to such innovation is the unavailability of long-term venture finance.

S RameshPresident - Finance & Planning, Lupin Ltd

The move towards original innovator drugs in India, though slow, is inevitable, and the opportunities are

immense. The fact that most global pharma majors like

Pfizer and GlaxoSmithKline are expanding their R&D presence in India

stands proof to this. Thus, Indian companies are sure to follow suit, as India develops into a global pharma hub.

The opportunities in drug discovery are tremendous, given the low cost of undertaking discovery and clinical development in India in stark contrast to increasing R&D budgets in advanced markets like the US. Thus, India can, with its global partners, share resources, costs and find & co-discover new ideas. Also, pharmaceuticals have one of the longest development cycles and regulatory review periods observed in any industry. Indian companies are presently not sufficiently equipped to independently navigate the lengthy, high-risk, high-cost clinical trials required to produce commercial drugs for the US or Europe, and then market them globally. Mastering the entire drug-development process will take time. Eventually, the Indian pharmaceutical industry will have to create its own proprietary drugs to boost its growth. Thus, this move towards innovator drugs is bound to happen.

The government’s measures, while encouraging the pharmaceutical sector’s R&D efforts, still leave a lot to be desired. In order to leverage and sustain the opportunity in R&D, the government should focus on developing as well as

harnessing the IP potential of the country. This can be done by incentivising R&D through a weighted reduction in tax breaks from the current level of 150 per cent to close to 300 per cent. Many countries give similar weighted deductions. Japan, Switzerland and advanced markets such as Germany provide weighted deductions as well as government grants to companies. This needs to be taken into account if we are to compete with them on a global stage. Also, a focus on breakthrough research will give the requisite fillip to R&D efforts in the country and give us an edge over other nations. Companies could also benefit tremendously if the government can grant tax holidays and extensions, especially for R&D.

India has a strong base of research scientists and other professionals with good knowledge of biotechnology & data management. Also, the cost of carrying out R&D activities in India is a big advantage. A considerable challenge faced by the industry is VC funding, which in India is severely limited. To thrive in the long term, Indian companies will need to make the transition towards innovative R&D-driven enterprises and will need to find creative solutions for challenges such as insufficient VC funding.

Indian companies would need to find ways to strike a balance between making high investments in innovation to help drive future growth, while still generating short term revenue growth from generic sales, in order to partake in the high risk drug development market. More collaborative drug discovery and development deals with innovator companies across the value chain would help Indian companies learn to innovate and enable significant knowledge sharing about how to run long-term R&D projects and use state-of-the-art analytical tools as well as process methodologies that would otherwise take years to develop.


PROF ILE

the Indian market has witnessed tremendous growth in biotechnology research over the years. The incredible

prices of the new molecules having commercial potential provided the right impetus for research in biotechnology. Actis Biologics Pvt Ltd (ABPL) is a biotech venture technology company that focusses on the lifesciences sector. Since 2005, it has been working with leading scientists and entrepreneurs worldwide to set up lifescience ventures in India.

Actis Biologics Group of Companies formed ABPL as a joint venture with entrepreneurs in India in order to target discovery of new molecules through collaborations and/or internal research or to in-license promising targets. As part of its commitment to building corporate value, it also aims to build an intellectual property portfolio that emphasises broad, enabling platform for technologies and discoveries. The company’s management approach involves bringing creativity and fresh thinking to Research & Development (R&D) while maintaining consistent attention to the details of financial and project management.

There are three pillars of strengths for ABPL, ie, manufacturing technologies

Since inception, Actis Biologics Pvt Ltd (ABPL) has been working towards finding cure for

life-threatening diseases like cancer and making disease prevention & cure more affordable

to the common man. Geetha Jayaraman explores the research initiatives of the company that

are set to revolutionise the biotechnology sector in India.

Formulating affordable therapeutics

Actis Biologics Pvt Ltd


PROF ILE

in biotechnology [Vesicular Fusion Factor 2 (VFF2) technology], biotech R&D (gene therapy research) and development of biotech parks. Says Sanjeev Saxena, Chairman & Chief Promoter, Actis Biologics Group of Companies, “I think the acquisition of VFF2 and angiozyme technologies has been a major turning point in the company’s growth. Also, our partnership with the Malaysian government for developing the Biocity in Malaysia has substantially enriched our credibility. So far, we are purely a biotech R&D-driven company, but plan to start manufacturing our products soon.”

R&D servicesABPL has an 18,000 sq ft state-of-the-art R&D laboratory at Marol Naka, Mumbai, to develop various pharmaceutical products. There are plans to set up a large pilot plant and manufacturing centre with an area of 11 acre in Khopoli, Maharashtra. R&D facility at Actis has one of the best current Good Laboratory Practices (cGLP) laboratories for recombinant, mammalian and bacterial yeast cultures. Moreover, it possesses level 2t & gene therapy laboratories with incineration at exhaust points to control any virus spillage and positive pressure corridors. Besides, all laboratories are in a clean zone

environment and accessible only with the help of electronic keys and electronic air-lock system.

Broad product range Though ABPL is yet to garner profits, the company has some unique features that make it a significant player in the Indian biotech industry. The range of its products from advanced research includes the following.

Angiozyme: This is the first product patent approved by US Food and Drug Administration (FDA) and Government of India. A novel class of molecule based on an outstanding ribozyme technology, the Angiozyme is said to be promising for the treatment of colorectal cancer. Further, it can be useful for various types of cancers including breast cancer, and weight reduction.

VFF2: It increases the yield of fermented products. Moreover, the

yield is nearly six times more in the fermentation of recombinant proteins. Thus, the production cost decreases to 20 per cent of the current manufacturing cost. Saxena avers, “VFF2 is a revolutionary technology, which can increase manufacturing output of bio-proteins like insulin or erythropoietin by eight times at the same cost of manufacturing. In other words, the cost of manufacturing reduces to one-eighth of the original cost.”

LIV-1: This is a patented product based on Ligand technology from CellPoint Diagnostics, USA. LIV-1has obtained 15 patents for its function of enabling delivery of an active anti-cancer drug into the liver. The Ligand technology is a mechanism that facilitates delivery of the active drug molecule to the targeted organ like liver or kidney, depending on nature of the disease. It

Sanjeev SaxenaChairman & Chief Promoter, Actis Biologics Group of Companies

The acquisition of VFF2 and angiozyme technologies has been a major turning point in the company’s growth. Also, our partnership with the Malaysian government for developing the Biocity in Malaysia has substantially enriched our credibility.

Experimental work being carried out at Actis Biologics Pvt Ltd


PROF ILE

enables focussed delivery of specific anti-cancer drug into the tumour for its treatment. The entire pre-clinical trials have been completed for LIV-1. To appreciate the quality of technology, the USFDA has given LIV-1 the status of an orphan drug. It will provide some financial assistance for conducting the trials in the US, as well as evaluate and treat approval applications through fast track means.

MSP 36: ABPL owns the patent for the gene therapy product—MSP 36. Currently, at its pre-clinical stage, this product is under further development in the ABPL laboratory in Mumbai. It has been proved effective in the treatment of breast and prostate cancer.

Interleukin (IL)-21: IL-21 increases immunity in humans and can also be useful as an effective supplement to boost immunity. ABPL has recently completed Phase I study for this molecule in the US.

Besides, the company is currently in the process of negotiating the acquisition of several additional patented molecules from various agencies in the US.

Manufacturing standardsABPL is currently preparing the Standard Operating Procedures (SOPs) to be followed in its manufacturing plant. The plant

is being designed carefully by preparing Basis Of Design (BOD) and specifications. The company is hiring its own contractors and managing the build-out as well as design of the plant, along with help from its colleagues from the US. ABPL is planning to acquire the most advanced instruments to ensure substantial increase in its productivity.

ABPL is currently putting together the plant under current Good Manufacturing Practices (cGMP) guidelines and planning to get an approval from the FDA as well as World Health Organization (WHO). Moreover, it is following

all other guidelines laid by the Indian authorities and US FDA. Saxena says, “I think any new-age company around the world follows these guidelines. We are competitive in our salary structure. Besides, we also encourage our employeesto pursue higher education and reimburse that. All employees can participate in a stock option plan, which allows them to have an ownership in their work and encourage feedback, suggestions, etc, as well.”

On a positive noteCurrently, ABPL is constantly working to bring its plans to fruition. It is developing MSP36using viral vector and plans to develop a large number of gene therapy molecules including gene therapy versions of insulin, erythropoietin (EPO), etc. It also has plans to develop targeted therapies by using Ligand linking technology, besides other types of ribozymes for applications outside oncology, eg, cardiology. “We are also working on our Biocity concept in Malaysia and the development of the Telesto system for detection, followed by real-time diagnostics and, ultimately, drug delivery. We are also planning to set up a bio-pharma manufacturing plant near Khopoli in Maharashtra,” points out Saxena.

VFF2 is a revolutionary

technology, which can

increase manufacturing

output of bio-

proteins like insulin

or erythropoietin by

eight times at the same

cost of manufacturing.

In other words, the

cost of manufacturing

reduces to one-eighth

of the original cost

Researchers at work in R&D laboratory of Actis Biologics Pvt Ltd


C O V E R S TO R Y

Tablet manufacturing machines have undergone a revolutionary change from the single-station tablet presses available earlier to the multi-station rotary presses today. Similarly, capsule manufacturing machines have metamorphosed with time. Moreover, these machines are equipped with cutting-edge technology to achieve high-speed productivity gains with precision. Saloni Vora analyses the related developments, emerging trends and likely future advances in these solid dosage forms machines.

C O V E R S TO R Y

Modern Pharmaceuticals May 201034Cover photo courtesy: Drugmaker’s Laboratories, Inc


C O V E R S TO R Y

the pharmaceutical industry has registered tremendous growth in the past few years. While most other

industries struggled during economic slowdown some time back, the pharma industry remained relatively unaffected and continued to register double-digit growth.

Besides, various allied sectors that cater to the requirements of the pharma industry, such as packaging, analytical equipment and IT & automation, have also experienced continued growth momentum. Similarly, the pharma machinery industry, which is one of the important sectors of the pharma industry, has made phenomenal progress by introducing state-of-the-art machines for various operations, eg, tabletting, capsulation, powder processing, material handling, coating, packaging, and R&D, so as to meet the growing demands of the pharma manufacturers. Piyush Tripathi, General Manager-Sales, Chitra Pharma Machinery, avers, “With the growing demand for various pharma products, the demand for pharmaceutical machinery has also increased. Leading countries like the US and Europe as well as South-East Asian countries like India, China, Turkey & Korea are making rapid progress in this sector. High-quality pharmaceutical machinery is being produced for manufacturing, inspecting and packaging of tablets, capsules, cosmetics, ointments & liquids by using advanced technology.”

Also, machines & equipment used to manufacture these products are constantly upgraded with respect to engineering excellence and cutting-edge technology to yield a better output. According to Mahendra Mehta, CEO, Parle Global Technologies Pvt Ltd, “Machine manufacturers are increasingly adopting technology-driven approach to enhance the quality of their product. They are incorporating modern technology like Computerised Numerically Control (CNC) machines

in their work units along with gadgets like Variable Frequency Drive (VFD), and Programmable Logic Controller (PLC) to enhance the user-friendliness of the machines.”

Current scenarioThe pharmaceutical industry produces numerous dosage forms like tablet, capsule, cream, ointment, suspension, syrups, pessaries, suppositories, etc. Of these, solid oral dosage forms like tablet & capsule constitute approximately 70 per cent of all forms of medicines and are widely used due to their distinct advantages over other dosage forms. Mehta believes, “The growing need and emergence of new avenues is resulting in increasing importance being rendered to pharma machinery used for the tablet & capsule manufacturing like high-end rotary tabletting machines, granulators, drying ovens, multi mills, mass mixers, coating machines, capsule filling & sealing machines, blister packaging machines, etc.”

With this changing trend, pharma machine manufacturers have also geared up to meet the industry requirements. States Ratnakar Shirali, Assistant Vice President-Manufacturing, Inventia Healthcare Pvt Ltd, “Present-day equipment are modular in design, offer best in metallurgy for MOC and are highly efficient in terms of output, operation & cleaning. With PLC-based operations, the equipment record complete data of the processes carried out, thereby meeting the requirements of 21 CFR part 11 as applicable.”

Seconding the reasoning, Karan Singh, Director, ACG Worldwide, says, “High speed and high technology machines, is what the market is currently seeking. With more pharma companies exploring opportunities and exporting to regulated markets, the machines & equipment used by them must meet the strict regulatory guidelines of documentation, performance & safety. Moreover, encapsulation machines and tablet compression systems are critically scrutinised, as these are in direct contact with the active formulation.”

Factors promoting developmentsAlthough the pharma industry has made remarkable progress in recent years, many challenges remain to be overcome. An array of factors has helped promote development in this domain. Comments Mehta, “Over the last 3-5 years, the global pharmaceutical industry has been facing key challenges like drying drug pipeline, product costing for effective product delivery worldwide, minimising manufacturing automation risks, extremely narrow margins etc. All these factors have acted as a trigger to demand for equipment suitable for handling multi-product manufacturing, high-speed applications, minimal operator intervention and being compatible with high-end plant automation.”

Besides these, a need to comply with stringent regulatory requirements is another factor that

Piyush TripathiGeneral Manager-Sales, Chitra Pharma Machinery

Most commonly used modern blenders include sigma, V, octagonal, double cone, bin blenders, etc. These design modifications have minimised the cycle time for any type of product blending and the different shapes, sizes, blade/ribbons mixes assist in blending the power homogeneously & result in a uniform final product.


C O V E R S TO R Y

drives the change. Supports Singh, “The main drivers for change have been regulatory requirements, starting from accuracy of capsule filling to high-precision maintenance of tablet WHT parameters on tablet compression systems. Further, more recent regulations require machines to be compliant with Process Analytical Techniques (PAT), ie, ability to check for critical product parameters in the process rather than with sampling, as well as complying with the Quality By Design (QBD) requirement. Another critical condition emerging in recent times is the need for 100 per cent weight checking of capsules and tablets. ACG is one of the few companies to have met this challenge by introducing the 100 per cent checkweigher, which can be integrated with the capsule filling and tabletting machines.”

Trends in solid dosage forms machinesDifferent steps are involved in the process of tablet and capsule manufacturing. The initial production steps involve the processing of powders into granulate, which are common to all pharmaceutical forms. Powders are ground by specific milling machines to obtain the required particle size to meet the technical requisites of production. In capsule manufacturing, capsule shells are produced from gelatin or plant-based gelling substances like carrageenans and modified forms of starch & cellulose. This is followed by the encapsulation process. For tablet

manufacturing, blending of the powders is followed by granulation & milling, followed by drying. The powder is then finally compressed to form tablets.

Although this process of manufacturing has remained nearly the same, many new equipment and machines have been introduced to facilitate faster and more effective performance of the above-mentioned processes. On the same premise, avers Mehta, “The principles of tabletting and

capsulation have remained relatively the same over the last 100 years but the equipment used to manufacture these have undergone transformation. Modifications have been introduced with respect to the electronics, automation & software, metallurgy of various components and designs for high-speed application.”

Trends in capsule manufacturingSince their inception, capsules have been viewed by consumers as an efficient method of taking medication.

There are two main types of capsules including hard-shelled capsules, which are normally used for dry, powdered ingredients, and the soft-shelled capsules, primarily used for oils and active ingredients that are dissolved or suspended in oil. Many machines used currently have the capacity to produce about 1.5 million capsules per shift. Says Mehta, “For hard gelatin capsule filling, in addition to increase output, the equipment are now designed for filling granules, pellets, tablets and liquids. For soft gelatin capsule applications, significant advances have taken place with the evolution of features like solvent-free system, where the use of solvent for capsule washing is completely eliminated. In contrast, medicine pumping systems are used for precision filling of the medicine for oil, gel or paste form. Further, jumbo size die rolls are used to augment the production capacity, while advanced tumble drying system is used to ensure faster and more efficient capsule drying.”

Besides, fluidocap encapsulation from ACG is another innovative system of packaging liquids in hard capsules, a technology that helps formulate products with faster acting capacity due to enhanced bioavailability. States Singh, “Liquids in hard capsules are superior in many ways to soft gel capsules. Most important being that the possibility of combination fills is practically impossible with soft gels. Also, the manufacturing can be kept in-house rather than contracting it out to a soft gel manufacturer.”

Trends in tablet manufacturingBlenders & granulators: For the

process of blending, many new-age blenders have been developed, which help reduce the cycle time for any type of product blending and also help reduce the downtime of product changeover. Elaborating more on the new variety of blenders, Tripathi says, “Most commonly used modern blenders include sigma, V, octagonal,

Mahendra MehtaCEO, Parle Global Technologies Pvt Ltd

The principles of tabletting & capsulation have remained relatively the same over the last 100 years but the equipment used to manufacture these has undergone transformation.

Future machines are

likely to be more

dependent on PLC

operation with minimum

human intervention.

The next big revolution

coming along is the

‘containment’ systems


C O V E R S TO R Y

double cone, bin blenders, etc. These design modifications have minimised the cycle time for any type of product blending and the different shapes, sizes, blade/ribbons mixes assist in blending the power homogeneously and result in a uniform final product.”

According to Shirali, bin blenders are most versatile, as bins that use bulk granule storage are used in the blender. Moreover, the same bin can be hoisted on the tabletting machine. This, in turn, helps eliminate downtime of product changeover.”

Besides, Singh believes that many pharma manufacturing companies are now adopting the fluid bed equipment (FBE) that perform the process of blending and granulation in a contained atmosphere. He adds, “Today, modern pharma companies have moved on to FBEs, which save space, cost and are relatively safer than the traditional blending equipment, considering that the solvents & active pharmaceutical ingredient (API) are processed in a contained environment.”

Compression systems: The new-generation compression machines have been designed such that they continuously facilitate minimal operator intervention and enable high-speed productivity gains. Avers Mehta, “These machines are characterised by numerous features, which include automatic weight control for on-line tablet weight monitoring & control, servo motor control for faster responses of weight control system & elimination of linear scales compaction force, constant amount feeder to handle difficult-to-flow granules, power lock system for turret that ensures perfect running of the turret without run outs, compaction force measurement for monitoring tablet hardness & weight variation, punch tightness monitoring system to avoid major man/machine damage as well as avoid downtime on account of the on-line magnesium spray system, etc. The above-mentioned features of the machine ensure that the cost of ownership of the machine

is truly value-for-money as well as result in a high product yield, minimum downtime & continuous uninterrupted usage at high speeds.”

One of the biggest challenges faced today by pharma companies, especially contract manufacturers, is products and tablet with a large variety of shapes & sizes that have to be manufactured within the same facility. Singh opines, “The need here is for a highly versatile tablet compression machine. Many modern compression machines are equipped with an interchangeable turret, which reduces product changeover time and increases the versatility of the tablet compression machine, enabling it to be used for tablets with different shapes and sizes—the two features customers are looking at today. ACG has identified this need and introduced the ‘interchangeable turret’ on its Legacy 6100. Ease of machine cleaning during a batch changeover is another important criteria, which is also addressed in this machine along with a unique recirculating feeding system that ensures minimal wastage and guarantees high yields.”

On the contrary, Shirali believes that today, the emphasis is on exchangeable compression module, where a unique design of the compression zone can reduce the product changeover time to a minimum. He further adds, “Except for the compression zone, the entire machine remains totally clean. With air-tight compression zone, if product demands stringent environmental condition, eg, low temperature or humidity or inert atmosphere, then such requirements are only restricted to compression zone and not the entire room, thereby reducing operational cost. Also, today, machines are available with various options like multiple layered tablets (2-5 layers), tablet-in-tablet and core compression.”

Quality certificationsMachines are being tailor-made to meet requirements of the pharma industry. Avers Arjun Rao, Director, Shree Bhagwati Machtech India Pvt Ltd, “Every pharma company has its own system of procedures for manufacturing and maintenance of its machines, as an effort to meet the

Ratnakar ShiraliAssistant Vice President-Manufacturing, Inventia Healthcare Pvt Ltd

Present-day equipment are modular in design, offer

best in metallurgy for MOC and are highly efficient

in terms of output, operation & cleaning. With

PLC-based operations, the equipment record complete

data of the processes carried out, thereby meeting

the requirements of 21 CFR part 11 as applicable.

Karan SinghDirector, ACG Worldwide

Many modern compression machines are equipped with an interchangeable turret, which reduces product changeover time and increases the versatility of the tablet compression machine, enabling it to be used for tablets with different shapes and sizes.


C O V E R S TO R Y

latest Good Manufacturing Mractices (GMP) compliance. In line with this, the company would want the machinery manufacturers to follow a set of procedures with proper documentation in the manufacturing. Most of the time, it is the pharma manufacturers, who educate the machinery manufacturers on the latest trends in the machinery and the upgradation in World Health Organization (WHO) GMP norms.” Quality certifications such as ISO 9001 are designed to help in standardisation of processes, provide better services and continuous improvement of systems in place. Mehta avers, “The ISO 9001 series has the standards representing an international consensus on good quality management practices (GMP). Further, the international regulatory requirements for the pharmaceutical machinery manufacturers are as per

current GMP (cGMP), US Food and Drug Administration (USFDA) standard. Moreover, it has become mandatory for pharma manufacturers to follow the ISO standards for pharmaceutical machinery to yield quality product.”

Opines Singh, “ISO 9001 refers to quality management systems, which are very important for any organisation, more so for companies that have products involving high level of sophisticated designing and engineering involved in manufacture. Our customers from India and from across the globe, are now insisting on a system-driven process, which ISO 9001 certification brings in.”

Future prospectsOver the years, capsules have evolved from hard gelatin type to soft gelatin ones and then the fluidocap

applications. Similarly, today, tablets are also available as single-layered, double-layered and in different shapes & sizes. Tripathi suggests, “Apart from the conventional methods of compression of tablets, modern drug discovery is one of the key factors in machinery development. Today, machinery has evolved from standard single-station compression to multi-station and from mini to mega press. With a continuous change and development in solid-form dosage system, machines used to manufacture these are also likely to evolve, to be more user-friendly, more advanced & more efficient in nature.”

According to experts, future machines are likely to be more dependent on PLC operation with minimum human intervention. According to Shirali, the scenario would be akin to batteries of machines being controlled through a console placed in a control cabin handled by an experienced hand.

Moreover, with the pharma industry moving on to more potent molecules and even towards biotechnology, ‘containment systems’ are likely to emerge as the technology in the future. Avers Singh, “The next big revolution coming along is the ‘containment’ systems. These machines have zero dusting and features like Clean In Place (CIP) & Wash In Place (WIP). Further, such system has to be integrated with encapsulation and tabletting machines. With high-potency drugs, regulators around the world are insisting on containment systems to ensure operator safety and meet ‘non-pollution’ regulations.” He concludes by adding, “At ACG, we are at an advanced stage of developing containment encapsulation systems, which meet global standards. The International Society of Pharmaceutical Engineering (ISPE) and other organisations are setting standards for the pharma industry and would provide training in these & other allied areas.”

Arjun RaoDirector, Shree Bhagwati Machtech India Pvt Ltd

Most of the time, it is the pharma manufacturers, who educate the machinery manufacturers on the latest trends in the machinery and the upgradation in World Health Organization (WHO) GMP norms.

Fluid ded dryer

dry mill

Tablet press

Tablet coater

Direct compression

dry mill

Blending/mixing

Dispensing

Hoist

Granulator

Co

urt

esy:

GEA

Ph

arm

a Sy

stem

Steps in tablet manufacturing

Hicofl ex® charge bag


S P E C I A L F E AT U R E

supported by phenomenal growth, the Indian pharmaceutical industry is advancing with multiple discoveries. These include

life-saving drugs, vaccines & biotechnology-derived therapies, biologicals, diagnostics and Human Cell & Tissue Products (HCTPs). The Indian market ranks fourth globally in volume and 13th in value. A study by McKinsey & Co states that the market will reach $ 20 billion by the end of 2015.

These trends have prompted infrastructural as well as technological developments in the pharmaceutical logistics and distribution system. However, these developments are slow and pharmaceutical companies are under a constant risk of damage to drugs during transit due to exposure to variable temperatures, improper handling, exposure to sunlight and oxidation. Thus, emphasis on proper transportation and storage system is increasingly becoming critical for the industry.

With companies in India increasingly focussing on good manufacturing practices and the growing presence of the country in discovery and manufacturing of vaccines & other multiple drugs, cold chain management has become an essential part of the pharma logistics system. Sumedha Mahorey investigates the need for better infrastructure & technology for the emergence of the cold chain, which complies with global norms and boosts overall growth.

Cold chain logistics

Calling for progressive development

Co

urt

esy:

Bio

sto

re U

K



Even after investing heavily on R&D, pharmaceutical and biotechnology companies are facing multiple challenges due to poor infrastructure and redundant technologies.

Currently, most pharmaceutical manufacturers and distributors outsource their logistics aids to save cost and focus on core competency. They believe that logistics service providers can offer professional help in decision making and logistics planning to create a more efficient supply chain and logistics operation. The need for cold chain management for temperature-sensitive drugs has evolved over the last five years.

An overviewCold chain is a logistics system that provides a series of facilities to maintain ideal storage conditions for drugs, temperature-sensitive pharmaceuticals from the point of origin to the point of consumption in pharma logistics. The chain starts at the manufacturing level and ends at the consumer or retail level. A well-organised cold chain reduces spoilage, retains the quality of drugs and guarantees a cost-efficient delivery to consumers, with adequate consideration to customer service. The key aspect of the chain is that if any of the links is missing or weak, the entire system fails leading to loss of profits and sometimes life as well.

The present cold-storage capacity in the country is grossly inadequate, and with a positive future outlook for the pharmaceutical industry, there is an urgent need to scale up and develop integrated cold chain facilities across the country.

The cold chain logistics infrastructure generally consists of pre-cooling facilities, cold storages, refrigerated carriers, packaging, warehousing and information management systems with traceability & tracking facilities.

There is immense scope for investment in this sector, which is still in

its infancy. “With more clinical trials and clinical research being outsourced to India, the last leg temperature-sensitive transportation to cities beyond C class will need investment in highly validated temperature-controlled boxes and last mile transportation,” says Christoph Remund, CEO, DHL Lemuir Logistics Pvt Ltd.

Growth drivers Major factors driving growth of the cold chain supply management in the pharma sector include increasing demand for healthcare in fast-expanding economies, increase in life expectancy and higher incidence of disease & accidents. However, the most important factor remains the spurt in research & development (R&D) activities and discovery of new drugs & pharmaceuticals. India has sufficient avenues of growth for cold chain logistics, but this opportunity can multiply only if the service providers initiate to tap the rural market.

Advancements in technology Over the years, technology in cold chain supply management has shown tremendous growth. Pharma companies are increasingly recognising the need for integrated solutions in supply chain management to maintain inventories at optimum levels. New and emerging technologies are now being utilised for smooth and efficient deployment of supply chain. Micro-process controls, transducers & automatic recorders are replacing mechanical equipment like

pressure gauges, thermometers and physical log books. Wi-fi cold storage monitors are increasingly being used to automatically control temperatures. Besides, innovative pallet shipper has been designed, based on the requirements of the lifesciences and regulatory sector.

Pallet shippers can be constructed as per the size of packages/pallets and temperature requirement. They have been engineered with high-performing, robust & reusable components that can be delivered flat packed and are completely recyclable, translating to less impact on the environment.

Industry-specific end-to-end temperature-controlled transportation solutions systematically integrate & rigorously measure all supply chain parameters to ensure proper storage, handling and distribution of temperature-sensitive medicinal products, delivering with few delays, less cycle time, less temperature deviations & few claims. Besides,

TempShell-system with standard blood bag

Christoph RemundCEO, DHL Lemuir Logistics Pvt Ltd

With more clinical trials and clinical research being outsourced to India, the last leg temperature-sensitive transportation to cities beyond C class will need investment in highly validated temperature-controlled boxes and last mile transportation.

Co

urtesy: D

elta T Gm

bH



recently, some modern technologies have also been incorporated. These include designs in thermal insulation, GTS reusable pre-qualified reusable solution (refrigerated, room temperature & frozen pack out), monitoring & tracking devices, temperature indicators, freeze watch indicators, temperature recorder/loggers (GPS), pre-qualification or design evaluation, temperature-controlled transportation & digital temperature alarm guardian for laboratories, storage areas and warehouses.

Government initiatives According to Remund, the government has provided cargo zones at airports, which are primarily used for export business. This is necessary to ensure proper storage of temperature-sensitive cargo, both inward and outbound. Such cargo zones ensure fast clearance of import/export cargo having a temperature-sensitive nature and offers better facilities under one roof. However, with current volume and projected growth in cargo, the storage space appears inadequate. For domestic supply during transit and storage of cargo, there is a need for a separate space for pharma products, as they require special environment.

Also, the proposed implementation of Central Goods and Services Tax (CGST) will significantly decrease the cascading effect and pave way for competitiveness of pharma goods &

services. The measure, if implemented in right earnest, will significantly reduce transaction costs. The government initiative will abolish the existing small tax windows, lead to seamless travel of products from one state to another and bring forth the true value of the product.

Quality and maintenanceThe onus of maintaining the cold chain is currently with the

manufacturer and the accountability lies with their distribution partners.

The Good Distribution Practices (GDP) published by World Health Organization in 2005 states - Where special storage conditions (eg, temperature & relative humidity) are required during transit, these should be provided, checked, monitored and recorded. Temperature mapping of vehicles (where applicable) should support uniformity of the temperature across the vehicle. Recorded

temperature monitoring data should be available for review.

“Drug manufacturers in India need to practise high standards of Good Manufacturing Practices (GMP) and conform to strict quality assurance requirements for the finished products. Once the manufacturer ensures highest possible quality and releases the stocks for distribution to the market, it is vital to realise the importance of appointing a responsible logistics player who will retain the efficacy of the product and ensure that it is not compromised,” says K D Sathya Narayanan, General Manager-Materials Management, Pharmacy & Stores, Manipal Health Systems Pvt Ltd.

Containers used for the storage and distribution of pharmaceutical products should not adversely affect the quality of the products and should offer adequate protection from external influences, including bacterial contamination. Thus, the focus increases on refining the cold chain management with specific reference to packaging solutions, temperature-controlled transport, temperature-controlled transit-holding stations, training on cold chain material handling, monitoring equipment, regulatory trends, regulatory guidance, and assurance & validation.

Key impedimentsIn India, huge obstacles such as technological, operational & co-operative issues, need to be overcome while transporting the pharma products. Though this industry has highly sophisticated technological possibilities, it needs more impetus to provide the highest quality to customer and the end-user.

“Issues like lack of logistical support, uneven distribution of cold chain, cost structure, power supply, increased regulatory oversight, audits & citations, enforcement of ‘ship to label’ with document proof

K D Sathya NarayananGeneral Manager, Materials Management-Pharmacy & Stores, Manipal Health Systems Pvt Ltd

Providing training to the staff that handles cold chain shipments, refrigerated surface transport services to reach all distribution areas, incentives to entrepreneurs to manufacture cold chain and relevant quality of packaging & monitoring devices should be the focus areas to boost development in this sector.

India has sufficient

avenues of growth for

cold chain logistics,

but this opportunity

can multiply only if

the service providers

initiate to tap the

rural market



(by multiple regulatory authorities), increased risks due to complex supply chain needs, and lack of service-level agreements with designated service providers for cold chain shipments have emerged as major challenges in this sector,” adds Remund.

There is extreme lack of infrastructure and significant lack of temperature-controlled equipment & facilities in India. Also, operational costs are high due to inefficient technology, as well as lack of trained personnel and integrated warehousing & logistics operations. These factors pose serious challenges to logistics players. Also, the service providers for the pharma industry need to update themselves on regulatory & legislative guidance worldwide, as shipping & storage of temperature-sensitive pharmaceuticals require strict procedures and adequate monitoring plans.

For cost reduction, pharma companies are struggling with the challenges of maintaining their cold chain facilities, rising regulatory compliance, customer demands, global market competition and internal pressures.

“Pharma cold chain management is not a volume-driven business. Hence, currently, companies prefer the parcel route as opposed to bulk transportation in refrigerated vehicles to maintain the cold chain. In the absence of an authority that implements regulations of cold chain management, many companies are not paying much attention to the established practices,” avers Ravi Jalan, CEO, Prasad Motors.

The distribution channel in India has multiple levels. At each level, there are associations comprising stockists or retailers that decide on the products and usually demand higher profit margins. Thus, pharma companies are unable to bypass this system and reach the customers directly.

Besides these issues, sourcing the right transporter for surface transport, ensuring holdings/transit warehouses have adequate infrastructure & training for handling cold chain shipments, reaching rural pockets, and the power crisis in rural areas are major concerns for cold chain logistics providers.

Need of the hourThe major advantage of the industry over most other nations worldwide is the low cost of labour and overall production in India. But, India is yet to capitalise on this factor owing to infrastructure constraints. To be at par with the global industry, the country needs to first overcome the infrastructure challenges, improve road-rail connectivity and utilise the latest technological advancements so as to deliver quality services.

Remund says, “Within the logistics space, India has not been able to make progressive development. India still lacks an extensive end-to-end cold chain distribution network, and the cold chain logistics network is currently weak. While the urban distribution network is more reliable, the rural distribution network is fragmented. Drug manufacturers are struggling through the highly fragmented nature of the distribution network. With a positive future outlook for the pharma industry, there is an urgent need to scale up and develop integrated cold chain facilities if India desires to be at par with global industry counterparts.”

Adds Narayanan, “The government needs to implement appropriate

regulation and monitoring bodies to ensure that standards are complied for cold chain products. Providing training to the staff that handles cold chain shipments, refrigerated surface transport services to reach all distribution areas, incentives to entrepreneurs to manufacture cold chain and relevant quality of packaging & monitoring devices should be the focus areas to boost development in this sector.”

Future trends This sector is poised for growth and likely to witness many developments in the years to come. Avers Jalan, “The industry is picking up but the pace is slow. There is room for more players, but in the absence of clear indicators that ad hoc measures will be phased out in the near future, investors are currently not keen on investing.” In the future, this sector will attract major companies with improvements in the cold chain system, technology and infrastructure. Rail-based reefers, product-specific cold chain facilities at airports, warehousing management, fully integrated logistics service, education and information access will facilitate better management of cold chain. Moreover, consolidation is expected in the near future, with many players merging and weak players leaving the market. Major players in the cold chain network are likely to emerge, with the current players achieving scale and higher utilisation levels.

Ravi JalanCEO, Prasad Motors

The industry is picking up but the pace is slow. There is room for more players, but in the absence of clear indicators that ad hoc measures will be phased out in the near future, investors are currently not keen on investing.


D R U G D I S C O V E R Y

Dr A K Batham

during the economic slowdown, the focus was majorly on redefining and remodelling the processes of drug discovery, development, marketing and

usage of new medicinal products. Although to some extent, the economy has recovered from the crisis, most of the new ideas, philosophy & strategies detailed in this article would be relevant and rewarding even after complete economic recovery. The article illustrates remodelling of the use of medicinal products, with special reference to new products.

Therapeutic applications Medical healthcare provider, ie, the doctor, decides the right treatment modality from a wide-ranging choice of pharmacotherapy, surgery, radiotherapy, physiotherapy and psychotherapy for patients. Besides, in the

modern age, a plethora of alternative therapies is available. In pharmacotherapy or drug therapy, the Indian healthcare provider can select modern medicines or Ayurvedic, Unani, Siddha and Homeopathic medicines (AYUSH) or dietary supplements. This article outlines the rational use and smart therapeutic applications of modern medicines.

The prescriber looks forward to a medicinal product that is safe (in terms of therapeutic gain), effective, convenient for use (easy to administer and one that has an acceptable dosage regimen) and cost-efficient (pharmaco-economical, ie, providing value for money in terms of cost of the medicine vis-a-vis efficacy, safety, dosing convenience as well as monitoring expenses).

Essential drugs & their rational use All prescribers, drug regulators, medical academicians as well as pharmaceutical companies, dream rational use of drugs, which according to World Health Organization (WHO) means the following: ‘patients receive medications appropriate to their clinical needs, in doses that meet their individual requirements for an adequate period of time, and at the lowest cost to them and their community.’

In consonance with this philosophy, WHO has published a list of essential drugs taking into account public health relevance, the best available clinical evidence of efficacy and safety as well as an assessment of comparative cost-effectiveness. The selection of essential medicines, hopefully, should result in improved quality of care, better management of medicines and a cost-effective use of available health resources.

The healthcare provider, while prescribing drugs, finds himself in a ‘therapeutic jungle’, which includes innumerable brands, dosage forms and strengths of drugs from several pharma companies. Multiple formulations of a particular drug are available for treatment of a disease, which enable the prescriber to choose the right formulation according to needs of the patient, type and site of the disease. Thus, an informed prescriber carefully researches new drugs and prescribes one that best suits the patient requirements, is safe, effective, convenient for use, and cost-efficient.

Remodelling medicinal products

Offering multiple therapeutic options

Courtesy: www.img.webmd.com



The WHO essential drug list and a similar list released by India, if seriously put into practice, can solve, to a very large extent, the problem of ‘me-too’ drugs and push such agents out of the therapeutic arena if medical practitioners are able to overcome the pressures from the marketing divisions of aggressive pharma companies.

Therapeutic ‘jungle’Numerous pharmacological and chemical classes of drugs are available for the treatment of a disease or mitigation of symptoms and other purposes. While prescribing drugs, the healthcare provider finds himself in a ‘therapeutic jungle’, containing an astronomical number of brands, dosage forms and strengths of drugs manufactured by more than 20,000 pharmaceutical companies. This phenomenal number of drugs is from approximately 270 large R&D-based organisations of national and multinational origin. One has to search the voluminous guides, eg, Indian Pharmaceutical Guide (IPG), Indian Drugs Review (IDR), Current Index of Medical Specialties (CIMS) and Monthly Index of Medical Specialties (MIMS) to search for the most suitable brand, dosage form, strength & price of the product. There are several ‘me-too’ drugs in each therapeutic category. Currently, in an attempt to gain patent life extension, pharmaceutical companies have adopted parallel and short-cut routes of developing new medicinal products. They have begun developing chiral, pure forms of drugs, and new drug delivery systems. Making the matter even more confounded is that various fixed-dose combinations, in different proportions, rational or irrational (but most importantly rationalised), are marketed under several brands.

In the last 30-40 years, the phenomenon of ‘me-too’ drug development has been responsible for introduction of hundreds of new drugs. For example, more than two dozen of

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) have been introduced, which had small gain in terms of reduced upper gastrointestinal adverse effects, but big loss in the form of increased risk of thromboembolic cardiovascular mortality. Several first-generation anti-histamines were introduced with the aim of producing agents without sedation and atropine-like adverse effects. Many second-generation drugs possessing these benefits have been successfully introduced, but it is yet to be seen how many of these can be absorbed by the market. Similarly, gastric acid anti-secretory drugs, like H2-receptor blockers (eg, histamine & ranitidine) have revolutionised the management of acid-peptic disorders and gastro-oesophageal reflux disorders (GERD), nearly eliminating surgical treatment. This was quickly followed by the introduction of proton pump inhibitors (PPIs) such as omeprazole, lansoprazole and pantoprazole. However, it remains to be seen how many ‘me-too’ drugs could be marketed successfully.

There is a big concern about branded medicinal products being over-marketed and over-prescribed, for conditions without sufficient research to support the use.

Catering to unmet medical needsPharmaceutical companies and research departments of various universities are continuously engaged in developing new medicinal products to fill-in the therapeutic lacunae for unmet medical needs. This is highly salutary, with a need to shift from control to cure of chronic diseases like hypertension, diabetes mellitus, dyslipidemias and obesity. There is an urgent requirement of effective, safe, accessible & affordable drugs for auto-immune disorders, cancers, AIDS, bovine spongiform encephalopathy (BSE), brain and spinal injury, cerebral stroke & myocardial infarction. Therefore, the prescriber should research the drugs and use the one that he wants to prescribe for these conditions.

Poor therapeutic efficacyTo refine the drug treatment in individual cases, the prescriber should take into account factors responsible for poor therapeutic response or lack of efficacy. These factors are poor choice of the drug, inadequate or sub-therapeutic doses, improper dosage regimens, misdiagnosis, poor compliance of the patient to the recommended dosage regimen, co-associated medical conditions, emergence of a new disease, concomitantly administered drugs & undetected genetic, psychological & environmental factors, etc. Development of tolerance and hypochondriacal nature of the patient are other factors that require consideration by the prescriber to extend the benefits of medicinal therapy.

Cautiously using new products New products should be cautiously and carefully selected in the light of claimed additional gains in terms of improved efficacy, reduced adverse effects, dosing convenience and higher pharmacoeconomic efficiency. Ideally, a good prescriber should not be the first to prescribe a new product and the last to abandon an old and obsolete product.

A good prescriber can always indulge in doing a ‘n of 1’ clinical trial to compare the new product with a



placebo or standard drug in a patient with chronic and stable disease. In such an experimentation, the outcome of the treatment would be relevant to the particular patient.

Fixed-dose combinationsAccording to the therapeutic needs and popular use of two or more drugs individually, many fixed-dose combinations of drugs representing refinement or redefinition of therapy, have been developed. There are innumerable examples of such fixed-dose combinations ranging from estrogen-progesterone oral contraceptives to anti-tuberculosis combinations, anti-hypertensives with low-dose hydrochlorothiazide, multivitamin-multimineral combinations, ampicillin-cloxacillin, amoxicillin-cloxacillin and ibuprofen-paracetamol. Such combinations are used to enhance efficacy or increase the safety by minimising adverse effects or to offer convenience of administration and consequently enhance patient compliance as well as ensure positive outcome of therapy.

New drug formulationsPharmaceutical companies are making enormous R&D investments to develop new drug formulations or new drug delivery systems that are targeted towards the desired site of action in the body. Multiple formulations of a drug or combination of drugs provide options to the prescriber to choose the right formulation suiting the needs of the patient.

The industry has produced many good and desirable new formulations & drug delivery systems, and completely modified the treatment practices in certain disease areas, such as bronchial asthma as well as other chronic obstructive pulmonary diseases.

New concepts in the clinic A good prescriber is responsible for detection, evaluation and prevention of adverse effects of drugs that remained

undetected in the pre-marketing clinical trials due to their rarity or occurrence in some specialised population groups or occurrence on long-term usage. Rare adverse drug reactions, ie, those occurring in 1 in 1,000 and above cases, are not detected in pre-marketing studies, and are discovered when large populations of several countries are exposed to treatment with new drugs. Certain patient groups like very old people or small children or patients with other morbid conditions associated with the primary disease being treated, such as diabetes mellitus, obesity, mild-to-moderate failure of liver

and kidneys, may respond differently to a medicinal product. Patients on other concomitant medications including herbal, ayurvedic, homeopathic or over-the-counter medicines or dietary supplements may develop adverse drug interactions.

Some dietary elements, such as grape fruit juice, tyramine-containing food items like meat & beans, may cause adverse drug reactions. Different races & ethnic groups of people may respond differently to drugs and may show poor therapeutic response or exhibit adverse drug effects peculiar to them because of different genetic constitutions. Often, geographical area and type of food consumed by people may also affect drug responses.

The prescriber, through his keen observations, can also find further new applications of drugs marketed for approved indications.

Most drugs used in cardiovascular, neurological & other chronic disorders require confirmation of benefits in terms of prevention of further morbidity, reduction in mortality and increase in life expectancy. Drugs that demonstrate efficacy on primary end-points but failed to reduce mortality and instead increased the instances of death on long-term usage, such as encainide, flecainide & moricizine have now been discontinued.

Doses and dosage regimens suitable for a particular population are also refined during extensive therapeutic use. Drugs recommended once-a-day dose, such as enalapril hydrochloride, have been found to produce adequate benefits lasting for 24 hours in a twice-a-day regimen. Similarly, new dosage regimens are also developed by the users, such as low-dose methotrexate given three times a week in certain autoimmune disorders like psoriasis and rheumatoid arthritis.

An informed, aware and conscientious prescriber can contribute significantly in adding new knowledge and generating novel concepts that could be taken to research laboratories for development of new medicinal products.

Dr A K Batham is Executive Director, ACEAS Clinical Research, Ahmedabad. He has worked as

a Medical Director for large Indian pharmaceutical companies and possesses an extensive experience of more than 27 years in clinical research, regulatory affairs, and medico-marketing in the pharmaceuticals industry. He is also engaged in providing training and consultancy services in clinical research and medico-marketing to pharmaceutical companies and CROs. Email: [email protected]

Multiple formulations of

a drug or combination

of drugs provide

options to the

prescriber to choose

the right formulation

suiting the needs of

the patient, disease

and the site

of disease


MARKET ING

Rendering personalised services

A good rapport of a medical representative (MR) with the physician greatly helps the latter to

recall the company’s brands. However, building this relationship itself is a daunting task. Thus, for

appropriate promotion of its products, the pharmaceutical marketing team should be thoroughly

aware of prescribing habits of a particular physician, his qualification & mindset as well as his

work schedule. For this, the management team can classify physicians into different categories

and, accordingly, the marketing team can plan a strategy towards achieving its goal.

Dr Rajan T D

the Medical Representative (MR) and his managers usually have a daunting assignment at hand. They need to build

a good rapport with the physician, thereby helping him to recall the company’s brands. Building a comfortable ‘relationship’ with the physician is itself a stupendous task. Knowing the physician closely is integral to ensuring brand survival. Small gestures like gifting useful items can be advantageous if the doctor values it, but at the same time, it may become a nuisance to some other physician. The difficulty for the MR, however, is the inability to decide the perceived value of a gift. In order to solve this conundrum, the MR needs to study the doctor’s nature of practice.

An MR meets doctors of all ages and with various qualifications. Some physicians are new, whereas others would have decades of experience in their practice. Doctors with varied qualifications have different approaches to prescribing drugs. Ideally, physicians are authorised to practise only within the area of their own qualification. However, in India, it is common to come across doctors with degrees in BHMS and BAMS prescribing allopathic medicines. There are also instances where doctors with degrees in

MBBS and MD recommend homoeopathic or ayurvedic drugs. The MR should be minutely aware of such prescribing habits so as to pitch in his products appropriately to the different segments of doctors.

Classifying physiciansFrom the point of view of modern pharmaceuticals, physicians can be broadly classified into two groups: allopathic physicians and practitioners of alternative medicine. Pharmaceutical companies

Novel approach to bolster drug promotion


MARKET ING

can freely promote their products to all doctors, and the responsibility of prescribing these products lies with the concerned physician. It is important for the marketing team to be aware of the physician’s qualification and mindset as well as his work schedule.

A thorough knowledge of the various modalities of practising the art of medicine will help pharmaceutical managers to appropriately build strategies for promoting their products. Most companies consider doctors only as consultants belonging to various specialities and tailor an all-encompassing approach to market the drugs.

It is difficult to accommodate all practitioners of medicine into a single classification system. However, they can be grouped under different systems. A simple classification of medical professionals in India, which includes four major classes, is elaborated here.

Doctors in service: This category includes full-time doctors at medical colleges/major hospitals. All medical colleges in India have large number of teachers from different specialities. These physicians have a duty consisting of 8-hour shift of classroom lectures, laboratory work, ward responsibilities etc. These personnel perform dual functions, that of teachers as well as treat or operate upon patients coming to the ‘medical college hospitals’. In some states of India, these doctors are permitted to take up private practice for limited hours. Thus, these physicians are mostly confined to their institutions.

Part-time doctors: The second category of physicians includes those working in public or private institutions for few hours and running their own clinics in the later hours. These physicians usually intend to gradually settle into private practice altogether once their practice becomes more stable. In our country, pay scales of doctors have never matched the amounts they earn in private practice.

It is only in the past decade that the government realised this and increased threefold the salaries of these doctors in order to retain good talent in their medical colleges.

Honorary physicians: They are usually Senior Consultants working in their private clinics but also devote some time to attend to patients in other hospitals. Honorary Professors at medical colleges conduct regular lectures and ‘teaching rounds’ in their wards to guide their students. Most of these professors are official guides and are responsible for assigning & coordinating thesis publication of their postgraduate students. Honoraries

usually earn less in these attachments but take pride in being a teacher with the medical university. They can also access the vast resources of the hospital library and have students who can help them carry out research work, publish their findings in reputed journals and present them at conferences.

Private practitioners: The largest group of doctors throughout the world is of private practitioners. The medical qualification and a membership with the national & state medical regulatory council confer the members the right to practise their art and also charge fees for it. Beginners of private practice usually rent out a place initially till their practice increases, and later on acquire their own clinic. Most general practitioners prefer to buy out the clinic from where they are operating.

Specialist doctors like physicians, cardiologists, orthopaedicians and dermatologists, usually begin their practice in rented cabins in polyclinics where different specialists share the same cubicle in different shifts during the day. Once the practice progresses, the expert tries to find a place of his own that meets his requirements.

Physicians in all categories of practice go through the lag, log and consolidation phases when their practice continues to remain secure & steady. The approach of the physician towards the pharmaceutical industry varies with his progress through these phases.

Planning promotion strategiesThe profile of patients attending a clinic can be surmised from the category that the physician fits into. Based on the segregation, the MR and his managers can plan a strategy towards achieving their goal.

Professors and teachers should be tackled differently from a private practitioner. For example, a lecturer at a medical college hospital will readily accept academic inputs like medical journals, teaching flowcharts and CDs, which will help him teach budding physicians.

Readymade materials for lectures prepared in audiovisual format are another method of invoking interest of professors and teachers. Academic institutions run by government or quasi-government bodies do not have sufficient funds for research activities or patient education services. Pharmaceutical companies can fill this gap and help the department in setting up such services. They can provide patient information leaflets on various diseases in vernacular languages to the departments, which can immensly help the overworked junior resident doctor, as he will not have to explain minute details to a literate patient. Making the physician’s life easy by such subtle acts will generate goodwill in the long term and ultimately reflect in prescriptions.

A deeper understanding

of the physician’s mind

would help the MR to

know any significant

impact made by a

particular promotional

service or a specific

method of drug

detailing


MARKET ING

Resident Medical Officers (RMOs) or resident doctors are usually busy preparing for their postgraduate examinations and they constantly need to be well-read & ready with answers to all questions. An RMO would appreciate a membership to a journal website or a subscription through which he can keep himself abreast with his subject. Conversely, the same gift given to a busy physician in private practice may not be of much use.

A young, energetic doctor working hard to build up his practice would readily accept help in getting his clinic organised and small gifts like a liquid soap dispenser or a umbrella stand would be greatly appreciated. On the other hand, Senior Consultants are disappointed by being presented with paper weights and tea-coasters.

Doctors in the age group of 35-45 mostly have children of school-going age. Gifting such doctors children’s books and encyclopaedia CDs could be useful, as their children tend to enjoy these readily. Likewise, events arranged for children, like drawing competitions and visits to interesting places provide moments to the marketing staff to interact freely with the physicians.

Physicians associated with charity hospitals and public hospitals cater to the middle-income group and the poorer classes. It would be futile to expect them to widely prescribe expensive drugs. A wiser MR would restrict himself to regular promotion of drugs that a doctor can actually prescribe and be happy about it, than to waste time with unrealistic expectations.

On a concluding noteThe survival of the MR, Area Manager and Regional Manager depends directly on the bottom lines of each quarter. A deeper understanding of the physician’s mind would help the MR to know any significant impact made by a particular promotional service or a specific method of drug detailing. Thus, the best way to approach the physician is to classify and reclassify.

Dr Rajan TD (MD, DVD, DNB) is an alumnus of Mumbai University and practises as a Specialist in Skin & STD in Mumbai since 1991. He regularly writes in various periodicals on several social issues as well as those relating to the pharmaceutical industry. He

has been the Associate Editor of ‘My Doctor’. He advises pharmaceutical industries on drug development, promotion and marketing strategies. Dr Rajan is an Honorary Consultant to ONGC, Indian Airlines, Air India and Larsen & Toubro Ltd. He also teaches at CMPH Medical College, Mumbai. Email: [email protected]


I N D U S T R Y I N S I G H T S

after patents for bio-pharmaceuticals expire, they can be produced and marketed by manufacturers

other than the original, subject to strict regulatory approval. Such a new biological medicinal product is known as ‘biosimilar’, as it is claimed to be ‘similar’ to an already approved reference product.

Cloning of human genetic material and development of in vitro biological production systems now allows creating virtually any recombinant DNA-based biological substance for eventual development of a drug. Monoclonal antibody technology combined with recombinant DNA technology has paved the way for tailor-made and targeted medicines, resulting in new approaches like gene- and cell-based therapies.

However, biotech medicines cannot be completely copied. This is recognised by the European Medicines Agency (EMEA), resulting in the establishment of the term ‘biosimilar’, which recognises the fact that, while biosimilar products are similar to the original product, they are not identical.

Moreover, the safe application of biosimilars also depends on an informed and appropriate use by healthcare professionals & patients. In the US, the Food and Drug Administration (FDA) has informed that a new legislation will be required to address these concerns.

The need for low-cost biosimilars Reportedly, proposals for the approval pathway of biosimilars, also called

Follow-On Biologics (FOB) in the US, can shape the future of the biosimilars industry. Reducing healthcare expenditures is the major agenda of many governments, and thus several developing nations are introducing regulations to govern biosimilars. Because biologics are among the most expensive therapies worldwide, regulating their cost is one of the key focus points. Moreover, it has increased the expectations from a regulatory pathway among participants of the biosimilars industry.

Europe is leading with 13 approved biosimilars belonging to three classes, namely, erythropoietin, granulocyte colony-stimulating factors and human growth hormones. In Japan, the first biosimilar was launched in October 2009. The market in Japan is now expected to gather pace due to its generic-friendly

Biosimilars are new approved versions of biopharmaceutical products post patent expiry of the original (reference) products. A biosimilar can only be similar and not identical to its reference product, as large biological molecules are complex in nature. Despite biologics being among the most expensive therapies worldwide, the global market for biosimilars is set to show excellent growth in near future. This article outlines the opportunities and scope in the market with regard to acceptance and adaptation of biosimilars.

Future of biosimilars

Opportunities galore

2500

2000

1500

1000

500

02008 2009 2010 2011 2012 2013 2014 2015

Reve

nue

($m

) CAGR (2008-2015) - 65.8%

Source: GBI Research

Biosimilars market (global) revenue forecasts ($m), 2008-2015


I N D U S T R Y I N S I G H T S

policies. The global market for biosimilars was valued at $ 66 million in 2008 and is expected to increase to $ 2,286 million in 2015 at a Compounded Annual Growth Rate (CAGR) of 65.8 per cent.

Entry barriersHigh costs of development and manufacturing favour large pharmaceutical companies with technical expertise, strong sales force and financial strength. Consequently, smaller players are unable to compete on financial grounds or production capacity. The biosimilars market is unlike the market for chemical drugs’ generics where the development and manufacturing costs are comparatively low. The expected price reduction for a biosimilar product is approximately 10–30 per cent of the original biologic (compared with a difference of more than 70 per cent between chemical drugs and their generic counterparts). This marked difference between the biosimilars and conventional generic drugs is because biosimilars, unlike conventional generic drugs, require pre-clinical & clinical studies to prove their bioequivalence and safety.

The cost of constructing a biopharmaceutical manufacturing facility is approximately $ 200–$ 500 million and the manufacturing process is complex. It requires technical personnel with expertise in biopharmaceutical manufacturing. The sales and marketing of biopharmaceutical drugs also needs an experienced sales force, which the smaller biosimilar companies lack. While financially robust companies can afford such high costs and can spend an average development time of six to eight years, smaller manufacturers are discouraged from entering the biosimilars market.

Interchangeability factorAn important point for developers of biosimilars is interchangeability, which makes the sale of biosimilars difficult in regulated markets. Moreover, there is no consensus in the US regarding the requirements for the bioequivalence of a biosimilar and an original product. One of the main challenges faced by the biosimilars market is the intrinsic difficulty in replicating the efficacy of the original product.

Biosimilars have similar therapeutic properties but are not identical, which makes interchangeability a major hurdle for rapid growth of the biosimilars market. Unlike generic versions of chemical drugs, biosimilars require pre-clinical & clinical studies for evaluation and comparison of their efficacy as well as safety, to be able to claim interchangeability.

A major issue for physicians is safety and efficacy of a new drug, as they need to be confident of the drug’s capabilities in order to switch. Further, substitutability means whether a hospital pharmacist can provide a biosimilar version of the original medicine prescribed by the physician. The manufacturers of branded biologics oppose the idea of automatic substitution at the pharmacy, as the characteristics of biosimilars and the original drugs are different. Europe has made significant progress in establishing a pathway for biosimilars, which other regions are expected to follow. In Europe, all medicines are given an 11-year data protection period and the decision of interchangeability or substitution remains with the member states.

Moreover, substitution of biosimilars for biologics is said to not happen in the future. Hence, the rapid uptake of biosimilars in

a manner analogous to the rapid uptake of the generic versions of conventional drugs is not possible due to the lower price differential, the lack of interchangeability and negative perceptions about biosimilars in markets, which have been traditionally consuming branded products.

The EU has also authorised a special approval procedure for biosimilars, based on a thorough demonstration of ‘comparability’ of the ‘biosimilar’ to an existing approved product.

Roadblocks Biologics generally exhibit high molecular complexity, and may be sensitive to changes in the manufacturing processes. Also, two similar biologics can trigger different immunogenic responses. Therefore, unlike chemical pharmaceuticals, substitution between biologics, including biosimilars, can have clinical consequences and create putative health concerns.

Moreover, there are several barriers to their entry to the market along with other regulatory obstacles such as sufficient investment in time and expertise as well as higher cost & risk incurred by manufacturers.

Future opportunitiesBiosimilars continue to exhibit substantial revenue gains and the impending patent expiry of many leading products has created innumerable & highly attractive market opportunities for them. However, legislative restraints in the US and regulatory framework in the EU have posed hurdles in the development of biosimilars. However, despite this, the field is set to offer lucrative returns to developers who are determined to proceed.

Courtesy: GBI Research

May 2010� Modern Pharmaceuticals 55

EVENTS

Process Industry Forum The theme of the event is ‘Achieving business excellence through automation and enterprise solutions in electric power, process & batch industries’. It would enable senior executives from pharma industry to develop and implement automation and enterprise strategies; July 14-17, 2010; at Hyderabad

For details contact:ARC Advisory GroupTel: +91-80-2554 7116 Email: [email protected]: www.arcweb.com

PROMACH 2010An exhibition featuring cutting-edge technologies and process plant & machinery for an array of industries including the pharmaceutical industry; October 01-04, 2010; atBangalore International Exhibition Centre, Bengaluru

For details contact:Bangalore International Exhibition Services Pvt LtdBengaluruTel: +91-80-65833234Email: [email protected]: www.bies.co.in

India Chem 2010An international exhibition & conference on pharmaceuticals, chemcials, plastics and process plant machinery; October 28-30, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai

For details contact:FICCI (Federation of Indian Chambers of Commerce & Industry), New DelhiTel: +91 11 23738760-70 Fax: +91 11 30910411 Email: [email protected]: www.indiachem.in

P-MEC India 2010An exhibition showcasing state-of-the-art pharma machinery and equipment for pharmaceutical operations; December 01-03, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai

For details contact:CMP India (UBM India Pvt. Ltd), MumbaiTel: +91 22 66122600Fax: +91 22 66122626Email: [email protected]: www.pmec-india.com

CPhI India 2010An exhibition on the pharmaceutical ingredients and allied industries.

The event is an opportunity for the exhibitors to display their novel and innovative technologies that are useful for formulation of pharmaceutical dosage forms; December 01-03, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai

For details contact:CMP India (UBM India Pvt Ltd), MumbaiTel: +91 22 66122600Fax: +91 22 66122626Email: [email protected]: www.cphi-india.com

ICSE India 2010An international contract services and pharmaceutical outsourcing exhibition. Companies providing research, development and production services would showcase their products and services. This would be the ideal place to find the right outsourcing partner. The expo would provide the platform to meet and network with outsourcing experts; December 02-04, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai

For details contact:CMP India (UBM India Pvt Ltd),MumbaiTel: +91 22 66122600Fax: +91 22 66122626Email: [email protected]: www.icsexpo.com

National

India’s premier industrial trade fair on products and technologies from machine tools, fluid power, instrumentation & control,

electrical & electronics, material handling, plastics, rubber, packaging, chemical, CAD/CAM, auto components, and general engineering.

For details contact:

Engineering ExpoInfomedia 18 Limited, Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

Tel: 022-3003 4649, Fax: 022-3003 4499 Email: [email protected], Website: www.engg-expo.com

IndoreMadhya Pradesh

Feb 18-21, 2011

LudhianaPunjab

Jan 2011

ChennaiTamil Nadu

Mar 04-06, 2011

PuneMaharashtra

Nov 19-22, 2010

AhmedabadGujarat

Dec 17-20, 2010

May 2010� Modern Pharmaceuticals 57

EVENTS

Interphex China 2010An international pharmaceutical exposition showcasing a wide range of pharmaceutical products and services. The event aims to bring together all pharmaceutical professionals under one roof and provides a great opportunity to learn about the current trends in the industry. A conference will also be organised concurrently with the exhibition; May 18-20, 2010; at Harbin, China

For details contact:Reed Sinopharm Exhibitions, ChinaTel: +86 10 84556693Fax: +86 10 62359314Email: [email protected]: www.interphexchina.com

ISPE Singapore Conference 2010With the theme ‘Celebrating growth and continuous innovation’, the conference provides pharmaceutical professionals an opportunity to discuss & exchange views and ideas about current trends in the industry; June 06-08, 2010; at Suntec, Singapore

For details contact:Reed Exhibitions Singapore Tel: +65 6789 8800Fax: +65 6789 7711Email: [email protected]: www.reedexpo.com.sg

PHARMATECH 2010An international exhibition on pharmaceutical packaging and processing; June 16-19, 2010; at Bangkok International Trade & Exhibition Centre (BITEC), Thailand

For details contact:Bangkok Exhibition Services Ltd, ThailandTel: +66 (02) 617 1475Fax: +66 (02) 617 1406

Email: [email protected]: www.besallworld.com

SIPEC 2010A pharmaceutical trade show that provides a good opportunity to network and generate new clients, while gaining an insight into the developments in the industry; September 28-30, 2010; at Parc des expositions d’Orléans, France

For details contact:Sipec, FranceTel: +33 (0)2 38 95 30 49Fax: +33 (0)2 38 95 24 29Email: [email protected]: www.sipec.net

BIOTECHNICA 2010An event for the biotechnology and lifesciences industries. It covers various elements in the field of biotechnology, including fundamentals, equipment and bioinformatics & services. An opportunity for associated people to find new customers and partners for their products & services and to network with various professionals from the industry; October 05-07, 2010; at Deutsche Messe Hannover, Germany

For details contact:Deutsche Messe AG Hannover, GermanyTel: +49 (0)511 89 0Fax: +49 (0)511 89 32626Email: [email protected]: www.messe.de

Expopharm 2010An exhibition highlighting the current trends and developments in the pharmaceutical sector. More than 500 exhibitors from diverse fields catering to the pharma industry are expected to be present at the event. The event presents an ideal opportunity to network with different

visitors and generate new contacts; October 7-10, 2010; at Munich, Germany

For details contact:WUV (Werbe- und Vertriebsgesellschaft Deutscher Apotheker mbH), GermanyTel: +49 (0)6196 - 928 412Fax: +49 (0)6196 - 928 404Email: [email protected]: www.expopharm.de

FOODPHARMATECH 2010An international trade fair for machinery, packaging and ingredients for the pharma as well as food industries. This year’s event would focus on four areas - efficient production, product safety, energy & environment and knowledge sharing. Professionals from the pharmaceutical, biotechnology and cosmetic sectors are expected to be present at the event; November 2-4, 2010; at Exhibition Centre Herning, Denmark

For details contact:Messecenter Herning, DenmarkTel: +45 99 26 99 26Fax: +45 99 26 99 00Email: [email protected]: foodpharmatech.dk

Bio-Europe 2010Considered to be one of Europe’s largest partnering conferences, the event attracts biotechnology and pharmaceuticals professionals. It provides an ideal opportunity to identify and enter into strategic relationship with companies of interest; November 15-17, 2010; at International Congress Centre, Munich (ICM)

For details contact:Bio (Biotechnology Industry Organization)Tel: +1 (202) 962 9200Fax: +1 (202) 488 6301Email: [email protected]: www.ebdgroup.com

International

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 Pharmaceuticals

Modern Pharmaceuticals May 2010�58

F R E S H A R R I VA L S

Medica Instrument Manufacturing Company, one of the leading pharmaceutical machinery manufacturers,

recently launched India’s first media preparator under the brand ‘Equiclave’.

“Launching media preparator under the brand name Equiclave is the logical extension of our range for which established competencies were already present. We have pooled in our vast experience in the manufacture and validation of steam pressure sterilisers (autoclaves) in developing our media preparator,” said Hemant Shah, CEO, Medica Instrument.

Equiclave is an autoclave with special features for handling liquid media, broth or other media.

For media preparation, it is directly poured into a special container in the autoclave, which also has a magnetic stirrer. Mixing takes place in the container, followed by the rise in temperature to a user-settable sterilising temperature, which is held for the desired time. This is then followed by rapid cooling of the media to its pouring temperature of 45-65 ºC.

Next, without opening the autoclave, an external peristaltic pump is used to dispense the desired volume of media directly onto petri plates, and placed on a clean bench.

Also, during this process, the media is constantly stirred to prevent solidification. The entire process is automatic and the user needs to only control and regulate the parameters as per his/her requirements.

Added Sachin Shetye, Senior Manager - Technical & Sales, Medica Instrument, “At the moment there are no local manufacturers. Also, there are very few media preparator manufacturers worldwide. Our product will have an edge over other manufacturers due to the distinct price advantage as well as far superior customer support infrastructure, considering the application knowledge that we pose.”

Medica introduces media preparator cum autoclave

Cognex Corporation recently announced the launch of In-Sight® Track & Trace, an add-on software package for Cognex In-Sight vision systems. The software delivers a ready-to-deploy data capture and verification solution designed to help pharmaceutical and medical device manufacturers to

achieve unit-level product traceability. Moreover, it combines powerful Cognex code reading and verification software with a pre-configured job file and HMI interface that reduces setup time and enables exchange of data with third party systems as needed for a complete serialisation solution.

Speaking about the software, Didier Lacroix, Senior Vice President, International Sales & Services, Cognex, said, “Track & trace solutions are becoming a high priority throughout the healthcare industry as a means of preventing counterfeit products from entering the supply chain, and for keeping authentic products from being diverted to unauthorised distribution channels and uses.”

He further added, “In-Sight Track & Trace provides the industry’s most reliable code reading and verification performance, and because it can be combined with a variety of third party products, users have the flexibility to customise and scale their serialisation solutions to best suit their budgets and needs.”

Microfluidics recently unveiled a new processing technology-Microfluidics Reaction Technology (MRT) claiming that it can help manufacturers save time and money by switching from batch to continuous particle production.

This system combines active pharmaceutical ingredient (API) nanoparticle production with multiphase chemical reactions and nanoencapsulationin a single production unit. “Currently, the typical batch crystallisation process involves several steps, often in locations across the country, which can take weeks. MRT simplifies the process and has been proven to reduce production time to a matter of hours,” said Dr Thomai ‘Mimi’ Panagiotou, Chief Technology Officer, Microfluidics.

The company also suggested that MRT’s consistency and stability enables the creation of particles of previously unattainable dimensions. In addition, Microfluidics announced the launch of MRT in Japan in collaboration with distribution partner Powrex, which simultaneously unveiled the system at a symposium in Osaka.

Takeshi Takashima, President, Powrex, suggested that the MRT platform would fit well with the Japanese pharmaceutical manufacturing sector’s approach to drug development and production. “Japanese companies and researchers are visionary innovators, and we are pleased to offer them the latest nanomaterials processing methods available to achieve new goals.”

Microfluidics introduces continuous nanocrystallisation technology

Cognex Corporation launches In-Sight® Track & Trace


F R E S H A R R I VA L S

GE Sensing and Inspection Technologies has introduced a new ValProbe® Cryo logger capable of covering a temperature range from -85ºC to +140 ºC to provide a single tool for a variety of applications.

The logger’s extended temperature range allows it to replace multiple products that were previously needed, leading to significant costs savings and productivity gains. GE believes that the logger is suitable for use in cryogenic chambers, lyophilisers, ultraflow freezers and other deep temperature applications.

“The Cryo Logger’s extended temperature range is a huge benefit to customers looking for a reliable, high-accuracy, wireless validation solution across ultra low and high temperature applications,” added Kranthi Tata, Global Product Manager, GE Sensing & Inspection Technologies.

Further, improvements in the new logger include three times longer battery life. The technology is also compatible with existing multi-channel and single readers operating with the ValProbe 1.5 software.

GE introduces new ValProbe® Cryo logger

Secure primary packaging solutions are crucial to support India‘s pharmaceutical industry in growing business in the domestic and international markets. To cater to this need, Schott Glass India has launched high quality special glass tubing for pharma packaging. A scientific analysis conducted by means of a glass grain test and surface test ensures that the glass shows no changes in

chemical properties even after 20 years. Mohan Joshi, President-Tubing Division, Schott Glass India, said, “Special

glass tubing made of ‘Fiolax’ offers high hydrolytic resistance, low interaction and exceptionally low alkali composition as well as superior workability during processing. Even after years, the drug is protected from influences of the external environment, thanks to excellent barrier and optional UV filter properties of the packaging.” Special glass tubing is used to produce syringes, vials, ampoules, cartridges, etc across the globe.

Schott Glass India, an affiliate of Schott AG, is the first local ISO certified glass tubing manufacturer.

Schott Glass India launches high quality special glass tubing

Share Information on your New Machinery & MaterialsThe mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour

by publishing information on your newly developed technologies that are applied in pharma and allied sectors. Manufacturers, developers and sellers of pharma-related products, machinery, materials and software are invited to furnish details for publication in this section of Modern Pharmaceuticals.

R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification.

Write to us: Modern Pharmaceuticals

Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 � Fax: 022-3003 4499 � Email: [email protected]

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

by the respective manufacturer/distributor. In any case, it does not

represent the views of Modern Pharmaceuticals

New Zealand’s Izon Science unveiled its latest breakthrough in nanoparticle analysis duringBIO 2010.

The Variable Pressure Module

(VPM) extends the capabilities ofIzon’s qNano and qViro instrument range providing the one of the world’s most comprehensive nanoparticle analysis systems.

Researchers using Izon’s nanoparticle analysis system can measure and characterise virtually all particles including nanoparticles, viruses, bacteria and bioparticles such as exosomes and liposomes. The system also aids analysis of particle concentration, electrophoretic mobility, size and aggregation kinetics. Real time reaction monitoring allows users to design and test nanoparticle systems by analysing the changes in particle properties as various modifications are applied. This is useful for bio-nano work, drug delivery research or development of diagnostic applications.

In addition, VPM provides precise control of liquid flow in addition to the standard electrophoretic operation of nanopores. These new analytical tools are expected to result in novel research in a number of nanoparticle related fields.

Novel nanoparticle system unveiled at BIO 2010


P R O D U C T U P DAT E

Vacuum conveyorsInternational Marketing Services offers ‘PIAB’ vacuum conveyors, which are specially designed for conveying of powders/granules from bins to the hopper of processing machines. These vacuum conveyors work on multi-stage ejectors, which generate vacuum by flowing compressed air at 4-6 bar. These are designed for close loop conveying and conform to the GMP & FDA Standards. There are no

moving parts hence the downtime for maintenance is minimum. Several variants of these conveyers are available with capacities ranging from 100 to 7,000 kg per hour. The control unit is pneumatically operated and do not require any type of electrical input. Several accessories like feed nozzle, PVC hose & fluidised cone are available as an option. The material of construction is SS-316L and the contact parts comply with USFDA standards.

These vacuum conveyors are used in pharma companies for formulations and in food processing industries.

International Marketing Services - Bengaluru - KarnatakaTel: 080–2331 0124, Fax: 080–2344 0604Email: [email protected]

Vacuum pumping unitAcmevac Sales offers vacuum pumping unit, which consist of rotary vane pump twin-lobe pumps as fore-pump and rotary vane pump or liquid ring pump as backing pump. The fore–pump picks up oil necessary for its lubrication from the backing pump. The exhaust from the fore-pump is connected to the suction side of the backing up, thereby giving an advantage of high pumping speed at higher vacuum. These units are energy efficient and consume less power than conventional single vacuum pumps.

These pumping units are of compact design and mounted on base frames ready for use. These are tailor-made and are offered to suit user’s requirements. These pumping units are used in chemical, pharmaceutical, dye, fertiliser, petrochemical, lubricant, power, metallurgy, electrical and allied industries.

Acmevac Sales Pvt Ltd - Mumbai - MaharashtraTel: 022-2837 5837, 2838 1053, Fax: 022-2836 4977Email: [email protected]

Cleaning nozzleIndustrial Equipwash offers fully automatic turbo tank cleaning nozzle powered by the cleaning fluid. It is designed for large volumetric tanks/agitators in the pharma, food, distilleries, beverage, chemicals and other process industries. The heart of the turbojet cleaner is an internal hydraulic motor, which makes the nozzles automatically perform a geared rotation around the horizontal and vertical axis. The number of cycles required for proper cleaning usually depends on the cleaning distance, cleaning procedure and cleaning agent. To control the RPM of the machine the flow rate is controlled through nozzles of various orifice sizes. A choice of nozzles is available to suit tank geometry and cleaning requirements.

Industrial Equipwash Inc - Mumbai - MaharashtraTel: 022-2679 7941, Fax: 022-2679 2936Mob: 098692 31815Email: [email protected]



Bottle filling machine

Laxmi Pharma Equipment offers compact automatic volumetric high-speed bottle liquid filling machine. The machine consist of a turntable, SS slat conveyor belt, filling & post gassing SS-316 nozzles, precision built SS-316 syringes, non-toxic synthetic rubber tubing, easy-to-reach compact panel, no-container no-filling system, etc. The compact, matt finished unit is totally enclosed in stainless steel. The unscrambler has been designed in the machine to eliminate dead ends and difficult to clean spots. All its exposed parts are made of SS-304, matt finish to avoid any reflection. It is provided with co-eccentric nozzles, which allow quick and precise setting. Its height can be adjusted to match other machines for efficient synchronisation. This machine is used in pharmaceutical, food & beverages, chemical and allied industries.

Laxmi Pharma Equipment - Ahmedabad - GujaratTel: 079-2583 1600Email: [email protected]



Industrial water filtersGopani Product Systems offers industrial water filters from Orival – USA. These are line pressure powdered filters available in sizes from 2” to 20” and have fine screens of size

minimum 10 microns in a variety of constructions, including standard stainless steel mesh, multilayered sintered stainless steel and wedgewire. Single units can handle flow rates upto 8100 gpm and it can be installed in parallel to handle larger flow rates. These filters are categorised into three series-I Series, P Series and B Series. The I Series consists of inline model having concentric inlet and outlet and are used in sidestream installations. The P Series on the other hand has a range of online models in which inlet and outlet are in parallel sequence. These are applicable on full flow applications. Finally, the B Series is a bypass model which is same as online one but with automatic bypass integral to unit. These are commonly used in full flow applications where a constant flow of water is critical.

Gopani Product Systems - Ahmedabad - GujaratTel: 079-2644 1972, Fax: 079-2644 2601Mob: 09712449259Email: [email protected]

Bridge handleElesa and Ganter India offers front mounting bridge handle with a n t i m i c r o b i a l protection. It is made of glass-fibre reinforced polyamide-based (PA) technopolymer with silver ions on an inorganic ceramic base. It is resistant to solvents, oils, greases and other chemical agents. The special antimicrobial material prevents any deposit of bacteria, mildew and fungi, thereby offering a sanitised effect on the surface. The resistance to high temperatures of the antimicrobial additive allows this handle to reach sterilisation temperatures (130°C). This handle is suitable for applications where hygienic and sanitary elements are required, especially in medical and hospital equipment, disability aids, machines for food processing & pharmaceutical industry, equipment for catering service as welll as urban & public fittings.

Elesa and Ganter India Pvt Ltd - Noida - Uttar PradeshTel: 0120-472 6666, Fax: 0120-472 6600Email: [email protected]

Fluid processorsTTL Technologies offers high shear fluid processors, which generate incredible levels of shear, up to 12.25 million per second. Operating with the same fixed-geometry interaction chamber technology of larger volume machines, it brings superior capabilities for uniform particle size reduction and cell disruption to samples as small as 1 ml. The increased shear enables biotechnology customers, for example, to achieve extremely high cell rupture rates for challenging applications (eg, yeast). In addition, media and chemical-free coupling, along with effective cooling, significantly improves protein yield and makes each millilitre of material more valuable.

Producing pressures up to 2069 bar (30,000 psi) with low power consumption, it is an efficient processor with a small footprint and quiet operation. It is easy to use and clean, and the results are scalable to production volumes.

TTL Technologies Pvt Ltd - Bengaluru - KarnatakaTel: 080-2525 1859, Fax: 080-2529 1285Email: [email protected]



Metal detectorTechnofour Electronics offers conveyorised metal detector for detection of metal contamination in food and pharmaceutical products. It is an eddy current-based digital metal detection system, which also finds application in chemical, cosmetics, garments, leather, rubber, and many other industries. The metal detector consists of electronic unit, test coil, conveyor and rejection mechanism. The functions performed by the electronic unit are diagnostics

on LCD display, auto product compensation, set parameter retention on loss of power, buzzer and LED indication on detection of metal contamination, LCD bargraph/numeric display to monitor noise and signal. Rejection mechanisms offered by the company are conveyor stoppage, air nozzle, diverter arm, flap and pusher/puller.

Technofour Electronics Pvt Ltd - Pune - MaharashtraTel: 020-2605 8063/4/5, Fax: 020-2605 8073Email: [email protected]



Oscillating granulatorJicon Machines offers oscillating granulator for uniform granulation of dry and wet lumps of powders. The main structure is fabricated from 304 grade stainless steel and the complete body is mounted on a strong stainless steel base for sturdiness. A 35-ltr gross volume hopper, which is

Rotary vacuum pumpAcmevac Sales offers monoblock rotary vacuum pumps. These are compact in size and are directly fitted on motor flange. These pumps are oil-free as no external lubrication is required. These are light in weight and hence easily portable. As the pumps are of compact design, they can be easily mounted on original equipment. These pumps are specially designed where oil free vacuum is required and finds application in packaging machines, printing machines, pharmaceutical machines, material handling equipment, etc. These pumps can be operated by single-phase and three-phase motors. These are available in capacities ranging from 40 ltr/min to 100 ltr/min, vacuum up to 24” Hg and maximum pressure up to 8 psi.

Acmevac Sales Pvt Ltd - Mumbai - MaharashtraTel: 022-2837 5837, 2838 1053, Fax: 022-2836 4977Email: [email protected]

Multi millBombay Pharma Equipments offers multi mill suitable for dry granulation, pulverising, shredding and copping of materials. Multi-speed drive is provided for various product grading. It is easy to dismantle & clean, and has an output of 100 to 250 kg/hr, depending on the characteristics of product and the screen size. Its features include easy maneuverability with the help of castor wheels. The machine is provided with motor (HP/1,440 rpm), beaters with knife and two scrapper blades. The company also offers vibro shifer, fluid bed dryer, tray dryer, etc.

Bombay Pharma Equipments Pvt Ltd - Mumbai - MaharashtraTel: 022-2859 4877, 2852 1608, Fax: 022-2852 1608, Mob: 098201 24804, 98201 20086Email: [email protected]

Cap sealing machineLaxmi Pharma Equipment offers automatic high-speed ROPP cap sealing machine. This compact machine is self-supported on stainless steel legs with adjustable screws for height adjustment. The machine is precision built on sturdy welded steel frame completely enclosed in stainless steel sheet. The doors are

provided to facilitate the servicing of machine. Built-in front control panel and hand wheel on the side of gear box motor slide helps in adjusting the speed of machine. The sealing unit and cap orientation unit are mounted on two pillars, which in turn are supported by top plate with individual height adjusting system.

Laxmi Pharma Equipment - Ahmedabad - GujaratTel: 079-2583 1600Email: [email protected]

provided for feeding is made of SS-304 GR material. The horizontal rotor assembly consists of SS-304, hexagonal rods and SS plates, with a main rotor shaft of 25 mm diameter. The grill-type removable cover is provided inside hopper. This grill cover protects operator from oscillating rotor and also prevents any accidental dropping of scoop, etc, inside operating chamber. A TEFC electric motor is provided along with a suitable reduction gear box.

Jicon Machines Pvt Ltd - Mumbai - MaharashtraTel: 022-2851 0398, Fax: 022-2851 6488Email: [email protected]



Mini capsule production machineFreund Corporation offers seamless mini capsule production machine. Spherical, uniform and seamless mini capsules within ±3 per cent weight variation and size in the range 1-7 mm diameter can easily be produced at

maximum speed. The thickness of the shell can be adjusted and the ratio of the shell and the core solution can be freely controlled. The strobe unit incorporated with the machine assures a visual inspection of capsule formation status during high-speed production. The machine can be easily dismantled and re-assembled for cleaning. The design of the machine is versatile and product design and output can be easily adjusted to the requirement. It is used for producing various type of capsules such as water-soluble, enteric and time-release capsules.

Freund Corporation - Tokyo - JapanTel: +81-3-5908-2616, Fax: +81-3-5908-2638Email: [email protected]

Rotary rinsing machineS S Packaging Industries offers automatic rotary rinsing machine. The bottles enter the machine through its inbuilt slat conveyor, are loaded automatically, rinsed from both inside & outside by the machine and get unloaded automatically at

the feed end of the conveyor. It is equipped with sturdy & robust gripping heads to invert bottles over spray nozzles during their travel on fixed cam/guide, which is 20-mm thick for extra rigidity and strength. The nozzles enter the bottle for proper and uniform rinsing, thus avoiding water splashing outside the bottle. The machine can be used for air cleaning or water rinsing. It can also be used for glass, PET and HDPE bottles of different shapes & sizes with additional change parts. The gripper assembly ensures a better grip, thereby avoiding turning of bottles during their travel in the machine. The machine has a separate round tray for spray water collection prior to its drain.

S S Packaging Industries - New Delhi Tel: 011-4705 2942, 6545 8134, Mob: 98102 79831Fax: 011-4507 2943Email: [email protected]



The information published in this section is as per the details furnished by the respective manufacturer/

distributor. In any case, it does not represent the views of Modern Pharmaceuticals

Turntable/scrambler & unscramblerKonark Machine Tools offers GMP model SS turntable/scrambler & unscrambler from 30” diameters to 42” diameters with three speed step pulley drives. All exposed parts are made of SS or aluminum to avoid rusting. It is provided with reduction gear, which ensures jerk-free and noiseless performance and allows absolute cleanliness even inside. The machine requires a power supply of 440 V, 3 phase (4 wire system), 50 cycles/sec. The company also offers horizontal plate sparkler-type filter press with reverse flow design for practically zero hold-up. It is offered on a common skid with filter aid dosing system. Its shell thickness is suitable to withstand higher pressure for long time. The comapany also offers rotary bottle washing machine, cap sealing machine, labelling machine, etc.

Konark Machine Tools - Ahmedabad - GujaratTel: 079-2760 2068/2212, Mob: 093749 90776Email: [email protected]

De-blistering machineJicon Machines offers de-blistering machine for recovering tablets, capsules, dragees from damaged or incomplete blister packs. A damaged or incomplete pack is inserted between two guides and pushed manually inside. This machine is driven by a continuous duty 25 Watt geared motor that operates on 200/230V, single-phase electric supply. An air circulation fan

is provided for ventilation. It is provided with three adjustable wheels, which grip and draw the pack under a rubberised roller. The machine is adjustable to suit most pack sizes. It is also suitable to open aluminum foil and glassine foil. The machine does not require any change-over parts and by proper adjustments of wheels, guides and pressure of rubber roller a high rate of recovery can be achieved.

Jicon Machines Pvt Ltd - Mumbai - MaharashtraTel: 022-2851 0398, Fax: 022-2851 6488Email: [email protected]

Flo-coater systemCapcon offers multi-purpose laboratory flo-coater system. It performs three processes – wet granulation via top spray, coating via wurster (bottom spray), and drying. It is a portable self-contained system with electrical and compressed air connection and integrated storage area for unused components. The system is provided with removable cartridge filters, removable spray gun and product screens. The colour touchscreen control system is used for validating process control, which include inlet air flow, inlet or product temperature control, and spray rate control. For maximum flexibility in processing, the system comes standard with product sampling port, inlet and exhaust HEPA filters.

Capcon - Thane - MaharashtraTel: 022-2537 7263Fax: 022-2542 2493Email: [email protected]

Third Fold HereGLUE

First Fold HereFirst Fold Here

Second Fold HereSecond Fold Here

��

�

Use

this

form

for

FR

EE

add

ition

al In

form

atio

n on

pro

duct

s pu

blis

hed

in th

is is

sue.

We

will

sen

d yo

ur in

quiri

es to

the

man

ufac

ture

rs a

nd a

sk th

em to

sen

d yo

u th

e de

tails

or

cont

act

you

dire

ctly

.H

ow

to

use

th

is f

orm

:��

Ple

ase

tick

agai

nst t

he b

ox o

f pro

duct

(s)

you

are

inte

rest

ed in

: ��

Men

tion

spec

ific

prod

uct/s

ervi

ce y

ou n

eed,

��

C

ompl

ete

all t

he d

etai

ls o

n th

is fo

rm.

��

Tea

r th

e fo

rm &

mai

l it t

o us

. (It

is a

pre

paid

mai

l)Te

l: +9

1-22

-300

3 46

84 /

4640

�� F

ax:

+91-

22-3

003

4499

�� E

-mai

l: b2

b@in

fom

edia

18.in

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

Send your inquiries at:Tel: +91-22-3003 4684 / 4640 • Fax: +91-22-3003 4499

E-mail: [email protected]

AC drives

Access controllers

Air chiller

Air shower controllers

Alpha press

Analytical instruments

Automatic cream fi lling machine

Automatic overwrapping

machine model

Automatic twin head powder

fi lling machine

B2B magazines

Blow-fi ll-seal machines

Bottle fi lling machine

Bridge handle

Cap sealing machine

Capping machines

Clamps

Cleaning nozzles

Coating machine

Collating & overwrapping machine

Colloid mill

Columns & chemistries

Communiting mill

Complete tablet bottle packing lines

Compressors

Conductors

Conical screw dryers

Cooling towers

Counters & power supplies

De-blistering machine

De-dusting & de-burring units

Door interlock systems

Double rotary tableting machine

Double-sided rotary

Dry syrup powder fi lling lines

Drying oven

Dust extractor

Electrical (both HT & LT)

Electrical connectivity

Empower

Encoders

Exhibition - India Chem 2010

Exhibition-Promach 2010

Factory automation components

Fire alarm

Flo-coater system

Fluid bed processor

Fluid bed system

Fluid processors

Gas conditioning and fi re

protection system

Giga press

GMP heat exchangers

GMP reactors

Handwheels

Hinges

HPLC

Hydrogenator/autoclaves

Indicators

Individual ventilated animal

caging system

Induction seals/wads

Industrial control & sensing devices

Industrial magazines,

pharmaceutical books

Industrial water fi lters

Informatics

Injectable powder fi lling machines

Inspection systems

Invertor/variable frequency drives

Latches

Level controllers

Levelling elements

Levers

Liquid fi lling lines

Liquid fi lling machines

LV motors

Magazine publisher & distributors

Marine air conditionier

Mass mixer granulator

Measuring & monitoring relay

Mega press

Metal detector

Mini CM mill

Mini roll compactor

Mini-capsule production machine

Moneycontrol.com

Motion controls

Multi mill

Oscillating granulator

Packaging machines

Packaging test equipment

Packaging solutions

Pass box inter lock systems

Photo-electric sensors

Pilot press

PLCs

Plungers

Process heat exchangers

Process reactors

Programmable logic controllers

Programmable terminals

Proximity sensors

Punches & dies

Pumps

Rapid endotoxin detection system

Rapid mixer

RFID

Roll compactor

Rotary multihead screw capping

system

Rotary rinsing machine

Rotary tablet press

Rotary vacuum dryers

Rotary vacuum pump

Rotating electrical connectors

Rotocone dryers

Safety light curtains

Scale watchers

Silicone carbide heat exchangers

Single rotary tableting machine

Solder paste

Spherical paddle chopper dryers

Spray analysers

Spray controller

Spray fabrication unit

Spray nozzles and accessories

Sticker (self-adhesive) labelling

machines

Switching relays

Tablet press machine

Temperature controllers

Three parameter display

Timers

Turnkey projects

Turnkey systems for dust

suppression

Turntable/scrambler &

unscrambler unit

Ultra deep temperature freezer

Unique SSV single seat valve

UPLC

Vacuum conveyors

Vacuum pumps

Vacuum pumping unit

Validation unit for packs

Ventilators

Vision products

Vision sensors

Washing and air jet cleaning

machines

Water/brine/hydraulic oil/

chilling plant

Wet glue labelling machine

Please complete the following & get a quick effective response from suppliers: 1. Your company’s business function is (�one only)

� Wholesalers � Manufacturer � Distributor � Agent � Other, please specify ______________

2. Your role in your company’s buying process can best be described as:

� I buy � I identify potential suppliers � I approve purchases

� I negotiate contracts � I select suppliers.

3. Your line of business

Name:

Designation:

Company Name:

Address:

City: Pin:

Tel: Fax:

Email:

5/

2010

Business Reply InlandBR Permit No. 555

Bhavani Shankar Post Office,Mumbai 400 028.

INFOMEDIA 18 LIMITEDRuby House, ‘A’ Wing, J.K. Sawant Marg, Dadar (W),Mumbai 400 028,INDIA.

POSTAGEWILL BEPAID BY

ADDRESSEE

NO POSTAGESTAMP

NECESSARYIF POSTEDIN INDIA

Special Projects

Use this form for FREE additional Information on advertisements published in this issue. We will send your inquiries to the advertisers and ask them to send you the details or contact you directly.

How to use this form:�� Please tick against the box of advertiser(s) you are interested in: �� Mention specific product/

service you need, against the advertiser’s name �� Complete all the details on this form. �� Tear the form & mail it to us. (It is a prepaid mail)

Tel.: +91-22-3003 4684 �� Fax.: +91-22-3003 4499 �� Email: [email protected]

Second Fold Here

Third Fold HereGLUE

ADVERTISER INQUIRY FORM

First Fold HereFirst Fold Here

��

�

Please complete the following & get a quick effective response from suppliers: 1. Your company’s business function is (�one only)

� Wholesalers � Manufacturer � Distributor � Agent � Other, please specify ______________

2. Your role in your company’s buying process can best be described as:

� I buy � I identify potential suppliers � I approve purchases

� I negotiate contracts � I select suppliers.

3. Your line of business

4. Specific product requirement

Name:

Designation:

Company Name:

Address:

City: Pin:

Tel: Fax:

Email:

5/

2010

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

�

AB Diachem Systems Pvt Ltd

ABB Limited

Alfa Laval India Ltd

Autopack Machines Private Limited

BIEC

Brothers Pharmamach (India) Pvt Ltd

Cadmach Machinery Co Pvt Ltd

CBS Publishers & Distributors

Chamunda Pharma Machinery Pvt Ltd

Charles River

Chilton Refrigeration

Citizen Industries

Cognex Singapore Inc

Dipesh Engineering Works

Elesa-Ganter India Pvt Ltd

Eltech Services Pvt Ltd

FICCI

Grundfos Pumps India Pvt Ltd

Misumi India Pvt Ltd

Money Control

Omron Automation Pvt Ltd

Progressive Engineering

Salesworth India Pvt Ltd (Rommelag)

Salesworth India Pvt Ltd (Seidenader)

Shimadzu Analytical (I) Pvt Ltd

Smart Logistics

Spraying Systems (India) Pvt Ltd

Sreelakshmi Traders

Sri Vishnu Pumps Mfg Co

Waters (India) Private Limited

Business Reply InlandBR Permit No. 555

Bhavani Shankar Post Office,Mumbai 400 028.

INFOMEDIA 18 LIMITEDRuby House, ‘A’ Wing, J.K. Sawant Marg, Dadar (W),Mumbai 400 028,INDIA.

POSTAGEWILL BEPAID BY

ADDRESSEE

NO POSTAGESTAMP

NECESSARYIF POSTEDIN INDIA

Special Projects


P R O D U C T I N D E X

PRODUCT SOURCING MADE SIMPLE

Product Pg No Product Pg No Product Pg No

AC drives.................................................................. 24A

Access controllers .........................................................61

Air chiller .....................................................................49

Air shower controllers..................................................61

Alpha press .......................................... Back inside cover

Analytical instruments .................................................29

Automatic cream filling machine.............................9,17

Automatic overwrapping machine model ...............9,17

Automatic twin head powder filling machine.........9,17

B2B magazines............................................................50

Blow-fill-seal machines ................................................15

Bottle filling machine ...................................................61

Bridge handle ................................................................62

Cap sealing machine ..................................................64

Capping machines ..........................................................5

Clamps................................................ Front inside cover

Cleaning nozzles ...........................................................60

Coating machine................................. Back inside cover

Collating & overwrapping machine .........................9,17

Colloid mill ........................................ Back inside cover

Columns & chemistries ................................................29

Communiting mill.............................. Back inside cover

Complete tablet bottle packing lines.............................5

Compressors..................................................................65

Conductors....................................................................63

Conical screw dryers.......................................................1

Cooling towers..............................................................49

Counters & power supplies........... Front inside cover A

De-blistering machine ...............................................66

De-dusting & de-burring units.......... Back inside cover

Door interlock systems.................................................61

Double rotary tableting machine ...... Back inside cover

Double-sided rotary .....................................................13

Dry syrup powder filling lines .......................................5

Drying oven......................................... Back inside cover

Dust extractor ..................................... Back inside cover

Electrical (both HT & LT)..........................................61

Electrical connectivity ..................................................63

Empower .......................................................................29

Encoders ......................................... Front inside cover A

Exhibition - India Chem 2010.......................................4

Exhibition-Promach 2010............................................39

Factory automation components........ Front gate fold

Fire alarm ......................................................................61

Flo-coater system..........................................................66

Fluid bed processor ............................ Back inside cover

Fluid bed system................................. Back inside cover

Fluid processors ............................................................62

Gas conditioning and fire

protection system ....................... Front inside cover B

Giga press ............................................ Back inside cover

GMP heat exchangers.....................................................1

GMP reactors ..................................................................1

Handwheels......................................Front inside cover

Hinges................................................. Front inside cover

HPLC .............................................................................29

Hydrogenator/autoclaves ...............................................1

Indicators .........................................Front inside cover

Individual ventilated animal caging system .................3

Induction seals/wads ....................................................63

Industrial control & sensing

devices ........................................... Front inside cover A

Industrial magazines, pharmaceutical books .............33

Industrial water filters ..................................................62

Informatics ....................................................................29

Injectable powder filling machines ...............................5

Inspection systems........................................................19

Invertor/variable frequency

drives ............................................. Front inside cover A

Latches..............................................Front inside cover

Level controllers............................. Front inside cover A

Levelling elements.............................. Front inside cover

Levers.................................................. Front inside cover

Liquid filling lines...........................................................5

Liquid filling machines...................................................5

LV motors .................................................................. 24A

Magazine publisher & distributors...........................33

Marine air conditionier................................................49

Mass mixer granulator ....................... Back inside cover

Measuring & monitoring relay .... Front inside cover A

Mega press........................................... Back inside cover

Metal detector ...............................................................63

Mini CM mill...................................... Back inside cover

Mini roll compactor ........................... Back inside cover

Mini-capsule production machine..............................65

Moneycontrol.com .........................................................2

Motion controls ............................. Front inside cover A

Multi mill ......................................................................64

Oscillating granulator................................................64

Packaging machines .....................................................5

Packaging test equipment ............................................63

Packaging solutions ......................................................63

Pass box inter lock systems..........................................61

Photo-electric sensors.................... Front inside cover A

Pilot press ............................................ Back inside cover

PLCs............................................................................ 24A

Plungers .............................................. Front inside cover

Process heat exchangers .................................................1

Process reactors...............................................................1

Programmable logic

controllers ....................................Front Inside Cover A

Programmable terminals..............Front Inside Cover A

Proximity sensors .........................Front Inside Cover A

Punches & dies................................... Back Inside Cover

Pumps............................................................ Back Cover

Rapid endotoxin detection system............................63

Rapid mixer ...................................... Back Inside Cover

RFID ..............................................Front Inside Cover A

Roll compactor .................................. Back Inside Cover

Rotary multihead screw capping system .................9,17

Rotary rinsing machine................................................65

Rotary tablet press ........................................................13

Rotary vacuum dryers ....................................................1

Rotary vacuum pump ..................................................64

Rotating electrical connectors .....................................63

Rotocone dryers..............................................................1

Safety light curtains ...................Front Inside Cover A

Scale watchers ............................................................ 24B

Silicone carbide heat exchangers ...................................1

Single rotary tableting machine........ Back Inside Cover

Solder paste ...................................................................63

Spherical paddle chopper dryers ...................................1

Spray analysers............................... Front inside cover B

Spray controller ............................. Front inside cover B

Spray fabrication unit.................... Front inside cover B

Spray nozzles and accessories ....... Front inside cover B

Sticker (self-adhesive) labelling machines ....................5

Switching relays ............................. Front inside cover A

Tablet press machine .................................................13

Temperature controllers ............... Front inside cover A

Three parameter display ..............................................61

Timers............................................. Front inside cover A

Turnkey projects.............................................................1

Turnkey systems for dust

suppression ................................... Front inside cover B

Turntable/scrambler & unscrambler unit...................66

Ultra deep temperature freezer.................................49

Unique SSV single seat valve .......................................25

UPLC .............................................................................29

Vacuum conveyors ....................................................60

Vacuum pumps ............................................................65

Vacuum pumping unit.................................................60

Validation unit for packs .............................................63

Ventilators .....................................................................65

Vision products...............................................................6

Vision sensors ................................ Front inside cover A

Washing and air jet cleaning machines......................5

Water/brine/hydraulic oil/chilling plant.....................49

Wet glue labelling machine ...........................................5

Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No


A DV E R T I S E R S ’ L I S T

Our consistent advertisers

AB Diachem Systems Pvt Ltd 24B

T: +91-11-25155456

E: [email protected]

W: www.abdiachem.com

ABB Limited 24A

T: +91-80-22949560


W: www.abb.co.in

Alfa Laval India Ltd 25


W: www.alfalaval.com

Autopack Machines Private Limited 17

T: +91-22-43054800


W: www.autopackmachines.com

BIEC 39

T: +91-124-4014060


W: www.promach.co.in

Brothers Pharmamach (India) Pvt Ltd 5

T: +91-79-40213213


W: www.brothers.co.in

Cadmach Machinery Co Pvt Ltd 13

T: +91-79-25841491


W: www.cadmach.com

CBS Publishers & Distributors 33

T: +91-11-23289259


W: www.cbspd.com

Chamunda Pharma Machinery Pvt Ltd BIC

T: +91-79-25842712


W: www.cm1981.com

Charles River 63

T: +91-80-25588175


W: www.criver.com

Chilton Refrigeration 49

T: +91-484-2544571


W: www.chiltonindia.com

Citizen Industries 3

T: +91-79-26445155


W: www.citizenindustries.co.in

Cognex Singapore Inc 6

T: +65-6325-5947


W: www.cognex.com.sg

Dipesh Engineering Works 1

T: +91-22-26743719


W: www.dipeshengg.com

Elesa-Ganter India Pvt Ltd FIC

T: +91-120-4726666


W: www.elesa-ganter.com

Eltech Services Pvt Ltd 61

T: +91-40-27759895


W: www.eltechservices.com

FICCI 4

T: +91-11-32910411


W: www.indiachem.in

Grundfos Pumps India Pvt Ltd BC

T: +91-44-24966800


W: www.grundfos.in

Misumi India Pvt Ltd FGF

T: 91-20-66470000


W: www.misumi.co.in

Money Control 2

W: www.moneycontrol.com

Omron Automation Pvt Ltd FIC A

T: +91-80-40726400


W: www.omron-ap.com

Progressive Engineering 63

T: +91-22-32944289


W: www.progressiveengineers.net

Salesworth India Pvt Ltd (Rommelag) 15

T: +91-80-25274495


W: www.seidenader.de

Salesworth India Pvt Ltd (Seidenader) 19

T: +91-80-25274495


W: www.seidenader.de

Shimadzu Analytical (I) Pvt Ltd 9

T: +91-22-43054800


W: www.autopackmachines.com

Smart Logistics 50,52,54,56

T: +91-22-30034651


W: www.eshop.infomedia18.in

Spraying Systems (India) Pvt Ltd FIC B

T: +91-80-39853200


W: www.spray.com

Sreelakshmi Traders 65

T: +91-44-24343343


W: www.sreelakshmitraders.com

Sri Vishnu Pumps Mfg Co 65

T: +91-22-28458372


W: www.minivacpumps.com

Waters (India) Private Limited 29

T: +91-80-28371900


W: www.waters.com

Mo

de

rn P

ha

rma

ce

utic

als

Ma

y 2

010

modern pharmaceuticals - may 2010

Documents

shashin tel

hari tel

rahul tel

jhuma tel

robin tel

prakash tel

ameya tel

jasmeet tel