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In Conversation With 14

Special Focus 15

Interface 17

Automation Trends 19

Dr Siva Kumar Pasupathi Country Manager - Life Sciences & Chemical Analysis Group, Agilent Technologies

The laboratory analytical market Status quo of India and developed countries

Paul Davies Global Business Manager, Malvern Instruments

Software-based automation Revolutionising pharma manufacturing

Court fines hospital for running an unlicensed pharmacy in Kerala

First Class Court slapped ` 24,000 fine on a hospital in Thiruvananthapuram district of Kerala for running an unlicensed pharmacy store in the hospital premise. The state deputy drugs controller seized a large quantity of expired drugs from the store, while the purchase records of the drug pharmacy were found incorrect.

Aurobindo gets approval for abacavir tablets

Aurobindo Pharma Ltd has received final approval from the USFDA to manufacture and market the earlier tentatively approved abacavir tablets USP 300 mg (ANDA 077844) and is ready for launch. Abacavir tablets USP 300 mg is the generic equivalent of ViiV Healthcare Company’s Ziagen® tablets 300 mg and is indicated as part of Antiretroviral (ARV) combination therapy for the treatment of Human Immunodeficiency Virus (HIV)infected adults and children. The annual sale of the product is approximately $ 88 million. The product has been approved out of unit III formulations facility in Hyderabad, India. Aurobindo now has a total of 169 ANDA approvals (143 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approvals) from USFDA.

Aanjaneya Lifecare ranked second in India at GIR summit

Aanjaneya Lifecare Ltd has received two prestigious awards and ranked No 2 in India and No 9 in AsiaPacific region at The Global Investor Relations (GIR) Summit. The event was co-ordinated by MZ Associates and KPMG in New York. Dr Kannan Vishwanath, Vice Chairman & MD, Aanjaneya Lifecare Ltd, said, “These awards assess the performance of the companies in terms of their corporate social responsibility, corporate governance and transparency. It would motivate Aanjaneya in furtherance of its endeavour to provide maximum value to its stake holders. We consistently look forward to continue our good performance in further achieving excellence and outstanding results in quality management, business excellence, customer satisfaction & corporate governance.”

Forest Laboratories and Glenmark in a worldwide collaboration Glenmark Pharmaceuticals S A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd India (GPL), has entered into an agreement with Forest Laboratories, Inc an international healthcare leader, on a collaboration for the development of novel mPGES-1 inhibitors to treat chronic inflammatory conditions, including pain. Glenmark has identified clinical candidates and is currently conducting preclinical studies and other Saldanha development activities required to support the initiation of first-in-human dosing. Under the terms of the agreement, Forest will make a $ 6 million upfront payment to Glenmark and provide an additional $ 3 million to support the next phase of work. Forest will make other future payments in FY 2014 to support the

advancement of the ongoing mPGES-1 inhibitors programme. Forest has an exclusive option to obtain license rights to the programme upon the completion of phase 1 clinical trials. “This collaboration reinforces our strategy of partnering to achieve our goal of launching innovative technologies around the world,” said Glenn Saldanha, CMD, Glenmark Pharmaceuticals. “Forest has an unrivalled reputation as a world leading pharmaceutical company. We are proud to be associated with them and look forward to working together. The partnership combines Glenmark’s proven track record of leadership and expertise in rapid, innovative product development and world-class manufacturing network with Forest’s development

and regulatory expertise and a strong commercial footprint.” “Forest continues to look for innovative ways to expand its broad pipeline including entering into early stage collaborations to secure access to novel products,” said Marco Taglietti, Senior VP-R&D and President, Forest Research Institute. “We are pleased to have entered into this collaboration with Glenmark, one of the leading discovery companies in India, which provides us access to a novel programme focussed on a high interest target that has the potential to benefit patients and physicians.” Both parties will work collaboratively to advance the programme into the clinic. The collaboration between Glenmark and Forest will be managed by a joint development committee with equal representation from both companies.

Micro Labs’ Baddi unit receives IMEA Award The Baddi unit of Micro Labs received IMEA award for manufacturing excellence. The award was presented by the Economic Times and Frost & Sullivan. Frost & Sullivan used its proprietary World Class Manufacturing

(WCM) model to evaluate the Baddi plant’s manufacturing procedure. The WCM model assesses manufacturing excellence adhering to high standards of customer satisfaction and return on total assets.

The Baddi unit mainly caters to domestic market and is equipped with in-house testing capability. The plant follows Quality Assurance Procedures (QAP) for all processes.

LifeCell launches LifeCell Stem Cell City LifeCell International has launched India’s first dual storage service, a unique initiative made possible with the inauguration of its new advanced stem cell center in Gurgaon (Manesar) near New Delhi. LifeCell’s dual storage service allows customers to simultaneously store stem cells in two geographically distant locations, ensuring maximum safety and complete protection against unforeseen events arising due to natural calamities. This service offers added reassurance to the clients that nothing is left to chance when it comes to preserving the precious stem cells. With the launch of the dual storage service, the collected stem cells will be simultaneously stored at the existing centre in Chennai and at the brand new advanced stem cell centre in Gurgaon (Manesar). The dual storage service will be available for LifeCell’s BabyCord service for umbilical cord stem cell banking and LifeCell Femme

for menstrual blood stem cell banking. LifeCell’s tie up with Sequel Logistics for sample movement through air cargo will ensure same day relocation of the sample to the Gurgaon (Manesar) centre after processing in Chennai. Mayur Abhaya, CEO and MD, LifeCell, said, “At LifeCell we are constantly implementing pioneering services that offer the highest quality standards in stem cell storage. The new facility in Gurgaon (Manesar) has further strengthened our commitment to our customers and enabled Abhaya us to activate the dual storage service, another milestone that provides additional security to the preserved stem cells. At a minimal added cost, both existing and new customers can store the stem cells at two independent and distant facilities.”

Lisa Ray, Actor, Model, Cancer Graduate & Global Stem Cell Activist, who announced the launch of Dual Storage Service, said “Everyone knows about the critical role stem cell therapy played in my fight against cancer. I am a living proof of how stem cells can save a life.” LifeCell Stem Cell City at Gurgaon (Manesar) can hold upto 2 lakh stem cell samples and can be expanded to store up to 10 lakh samples. Located at the Delhi-Mumbai corridor, the facility spans over a 2 acre plot with a floor area of 65,000 sq ft. The facility has an advanced technology infrastructure in-built with adequate safety measures for temperature control, monitoring and fire safety. It is manned with armed on-site security and online surveillance monitoring ensuring complete safety and security of the preserved stem cells.


M o d ern P harma•1- 15 Janur ar y 2013

CONTENTS Newsmakers of 2012

11

In Conversation With

14

Dr Siva Kumar Pasupathi Country Manager - Life Sciences & Chemical Analysis Group, Agilent Technologies

14

16

17

21

Special Focus Analytical instruments

15 16 17

The laboratory analytical market Status quo of India and developed countries FDI for analytical instruments A hit or miss?

Interface

Paul Davies Global Business Manager, Malvern Instruments

Facility Visit

18

Glenmark Generics Ltd Leading the ‘hormones’ segment

www.modernpharma.in

Insight & Outlook Automation Trends Software-based automation: Revolutionising pharma manufacturing Roundtable Should patented drugs be price controlled?

Interface

Dago Caceres Global Strategic Marketing Leader, Dow Wolff Cellulosics

Event Report

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl

19 20 21 26

64th Indian Pharmaceutical Congress Broadening horizons for small - and mid-sized pharma manufacturers

PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Pallavi Mukhopadhyay, Rishab Kothari, Nikunj Sharma (Delhi) ASSISTANT ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan CHIEF PHOTOGRAPHER Mexy Xavier PHOTOGRAPHY Neha Mithbawkar, Joshua Navalkar BUSINESS CONTROLLERS Surekha Karmarkar, Lovey Fernandes, Akshata Rane, Deepak Bhatia, Ashish Kukreti, Shwetha ME, Jayashree N, Sugandha Kulkarni, Shefali Mahant

PRINTING EXECUTIVE VICE PRESIDENT Ananth R Iyer ASSISTANT GENERAL MANAGER - PPC Shekhar Khot

PRODUCTION TEAM

Surekha Karmarkar, Ravikumar Potdar, Ravi Salian, Sanjay Shelar

REGULAR SECTIONS 5 Editorial / Guest Editorial 6 News, Views & Analysis 22 Projects / Tenders 24 Event List 28 Products 29 Marketplace 30 List of Products & Advertisers

Highlights of Next Edition Special Focus: Nanotechnology Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

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Views and opinions expressed in this magazine are not necessarily those of Network18 Media & Investments Ltd (Network18)*, its publisher and/or editors. We at Network18 do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. Network18 does not accept the responsibility for any investment or other decision taken by readers on the basis of information provided herein. Network18 does not take responsibility for returning unsolicited material sent without due postal stamps for return postage. No part of this magazine can be reproduced without the prior written permission of the publisher. Network18 reserves the right to use the information published herein in any manner whatsoever. Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18. Senior Editor: Manas R Bastia Printed at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition. *Ownership of this magazine stands transferred from Infomedia18 Ltd (Infomedia18) to Network18 Media & Investments Ltd (Network18) in pursuance of the scheme of arrangement between Network18 and Infomedia18 and their respective shareholders and creditors, as approved by the Hon’ble High Court of Delhi and the necessary approval of Ministry of Information and Broadcasting is being obtained.


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

Editorial

5

Transformational change beckons…

I

Editorial Advisory Board Ajit Singh

Chairman, ACG Worldwide & Head, ISPE

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah

Chairman, IGPA & Secretary General, IPA

Daara Patel

Secretary General, IDMA

t is that time of the year when everyone (well, almost) starts thinking about new beginnings, notwithstanding what most analysts predict after their fair share of crystal ball gazing. The fact that you are reading this obviously nullifies all the doomsday prophesies that sounded the death knell for the world with the end of the Mayan calendar. Although we are over it now, the troubles – especially the macro-economic ones – for a globally inter-connected world seem to be far from over! With the European Union still sputtering to accelerate and the near to mid-term economic forecasts for the Organisation for Economic Co-operation and Development (OECD) countries lacking the desired lustre, the emerging economies are most likely to continue their glorious growth march, albeit a bit slower, in the foreseeable future. The key points to be noted here are an increasingly inter-dependent world and the growing competition among several geographies to earn their share under the Sun. Against this background accompanied by country-specific competitive advantages as well as significant shifts in the application of technology and the need for more tailor-made products & services, the pharmaceutical domain is certainly not going to be the same in this year. Without focussing too much on the drag factors rather than the growth drivers, it is imperative to chart an optimum course for the pharma ecosystem of India and the economy at large. Of course, the right set of policies will further help leverage the

emerging opportunities and thus, enable India Inc to stay ahead in the race. In fact, according to the Report ‘India’s New Opportunity – 2020’ prepared by a high level strategic group, the nation needs to accelerate its economic growth beyond the rates of 5-6 per cent per annum in order to be counted as a major economic powerhouse by the end of this century’s first quarter. While the importance of India’s demographic dividend cannot be overemphasised, it is high time to specifically focus on nurturing and offering the right skill sets required for an ever evolving industry. To achieve this as well as an inclusive growth across several strata of India, the time has come for a transformational change. This calls for a shift from a mere compliance mindset to a commitment-driven focus on accomplishing the goals and transform ideas into actions with agility. Besides, superior efforts in improving the efficiency of organisations, building scale organically and inorganically and harnessing global expertise to improve operating margins will further aid in this direction. On this note, here’s wishing all our stakeholders an eventful and enriching 2013!

Manas R Bastia manas@network18publishing.com

Guest Editorial

Survival of the fittest!

Q

uality consciousness should be the primary concern of the analytical instruments segment in the pharma industry. And Foreign Direct Investment (FDI) is a positive move in this context. With FDI coming into the picture now there will be a standard quality benchmark. Without this, the companies would have been happy and content with what they were doing. No doubt, healthy competition is the automatic impact of FDI. Previously, the inspectors did not visit the plant very often but now they will be compelled to visit often and this in a way will raise the standards. Personally, I am supporting the introduction of FDI. We must remember FDI is a doubleedged sword and the usage varies from situation to situation. Thus, it is not appropriate to take one common formula and apply it to several industries. The application and the usage will differ from industry to industry. Further, improvement of import and export facilities is also an important criterion. There will be free flow of competition in the market. We must remember that the overall quality aspect should be better and improved. We need to have good

research facilities. I believe that it is the survival of the fittest, provided the companies offer quality and cost at the same time. We need to source good materials, proper metals, stainless steel, etc for analytical instruments. FDI will improve the quality of the Indian product or rather better the manufacturing process by working on cost reduction, etc. Good manufacturing management will also indicate proper time management. It is extremely important to comprehend that customer should have valid option while choosing the products. For the entire scenario to undergo several changes, the education sector also needs to undergo a revamp. It is sad to see that today there are several substandard PhD students. The standard of education needs to improve. We are making several introductions and recommendations so that due changes are taken into consideration. It is unfortunate that out of so many colleges in India only 3-4 colleges are well equipped with quality analytical instruments. If not completely working, there should atleast be a demonstration. There is no point in blaming the students unless the staff improves their education. In our days, the

teachers were more focussed in what they were doing. They had a passion for teaching. We must remember education is not just about obtaining degree but developing an entire research environment. Therefore, we have to focus on building quality culture. Dr G Ramakrishnan

Adjunct Professor, Chemistry, SIES College and President, Chromatographic Society of India


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Mo d er n P har ma•1 - 15 J anuar y 2 013

News, Views & Analysis Lupin to launch generic Yasmin® tablets; receives FDA approval Lupin Ltd’s subsidiary Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its drospirenone and ethinyl estradiol tablets, 3 mg / 0.03 mg from the USFDA to market a generic version of Bayer Healthcare’s (Bayer) Yasmin® tablets 3 mg / 0.03 mg. Lupin’s drospirenone and ethinyl estradiol tablets are the AB rated generic equivalent of Bayer’s Yasmin® tablets 3 mg / 0.03 mg. Lupin’s drospirenone and ethinyl estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women. Lupin will be marketing its drospirenone and ethinyl estradiol tablets USP in a wallet pack of 28 tablets consisting of 21 yellow active tablets, each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol, and seven white inert tablets. Yasmin® tablets had annual US sales of approximately $ 275.1 million.

iPHEX 2013 to showcase Indian pharma exports and R&D capabilities The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced the launch of iPHEX 2013, India’s own pharmaceutical show under the support of Ministry of Commerce & Industry, Department of Commerce, and Government of India. iPHEX 2013 shall be held in Mumbai from April 24-26, 2013 and over 400 leading Indian companies are expected to showcase the best of pharma products at the event. IPHEX 2013 will see the presence of 5,000 business visitors including overseas buyers and drug regulators. Huge business opportunities are expected to emerge during the event. Further, the presence of large number of drug regulators from overseas market will immensely help Pharmexcil and its members to promote the quality and affordability aspect as envisaged in Brand India Pharma Campaign. The campaign has been initiated by Ministry of Commerce and

executed by Pharmexcil in association with India Brand Equity Foundation (IBEF). Elaborating on the strengths of the Indian pharma industry, Dr P V Appaji, Director General, Pharmexcil, said, “India is the 3rd largest player in the world with 500 different APIs and ranks 4 th globally in terms of production volumes; and 13th globally in domestic consumption value. The country is the largest exporter globally of generic Dr Appaji formulations in volume. It exports vaccines to 150 countries and produces 40 -70 per cent of the WHO demand for DPT & BCG and 90 per cent of measles vaccines.” With increasing R&D spends, Indian pharmaceutical sector has become a cost-effective centre for world class research as also for contract R&D. Indian companies in recent years have

produced many cost-effective drugs that are affordable to the masses, said Ashutosh Gupta, Vice Chairman, Pharmexcil. “We are making concerted efforts to promote India’s status as the manufacturing hub of the world,” added Gupta. The Government has prepared a ‘Pharma Vision 2020’ document for making India one of the leading destinations for end-to-end drug discovery and innovation. Through this, the government provides support by way of world-class infrastructure, internationally competitive scientific manpower for pharma R&D and venture fund for research in the public and private domain. The government is also embarking on a major multi-billion dollar initiative with 50 per cent public funding through

a Public-Private Partnership (PPP) model to harness India’s innovation capability. The vision is to catapult India into one of the top five pharmaceutical innovation hubs by 2020, targetting to achieve a global niche with one out of every five to ten drugs discovered worldwide by 2020 originating from India. “The government has taken various policy initiatives for the pharmaceutical sector, including tax-breaks to the pharmaceutical sector and weighted tax deduction at 150 per cent for the R&D expenditure incurred. Steps have been taken to streamline procedures covering development of new drug molecules, clinical research etc. Indian Government has launched two schemes—New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Programme—specially for drugs and pharma research,” said Dr Appaji.

India revokes patent on Merck’s asthma drug

Indian Patents Office has revoked a patent for an asthma drug held by US-based Merck & Co following a challenge from domestic pharma firm Cipla. In an order, T V Madhusudhan, Assistant Controller of Patents & Designs, revoked the patent on the ground that it lacked invention. “The sole process claim also in its entirety is not inventive as the said claim does not describe any inventive feature,” the order said. ”In view of the above conclusion, I hereby order that the patent bearing number 246328 is revoked,” Madhusudhan said in his order. Schering Corporation, which was later acquired by Merck & Co, had applied for patent of the asthma drug in February 2004, and the Indian Patents Office had granted the patent in March 2011. Cipla had challenged the patent. The development is the latest in a series of patent revocations by India’s Patent Office. Last month, the Intellectual Property Appellate Board (IPAB) had turned down drug firm AstraZeneca’s plea for a patent on the lung cancer drug Gefitinib. Similarly, it had also revoked Pfizer’s patent on cancer drug ‘Sutent’. The drug was granted a patent in India in 2007 but Cipla had opposed it the following year. Earlier during the year, India Patents Office had invoked compulsory licensing permitting the Hyderabad-based Natco Pharma to manufacture and sell cancertreatment drug Nexavar at a price over 30 times lower than charged by its patent-holder Bayer Corporation.


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

News, Views & Analysis

Sotax India launches SPDS at 64th IPC Healthcare has always been one of the most challenging and dynamic sectors globally. Today, India is experiencing sweeping changes. New demands attract intellectual talents and give them an opportunity to contribute and grow. The pharmaceutical industry forms an integral part of the overall healthcare segment. In the current scenario, great emphasis is given on developing, formulating, manufacturing high quality, effective and safe drugs. Keeping the above in mind, an initiative has been taken to form the Society for Pharmaceutical Dissolution Science (SPDS) by a team of experienced senior professionals from the Indian pharma industry and academia. This initiative has been supported by Sotax India, a fully owned subsidiary of Sotax AG Switzerland, a global organisation that has pioneered dissolution science. The effort to establish the Society for Pharmaceutical Science began on July 16, 2012 with an

objective of bringing professionals and expertise in dissolution science under one roof. The seed of SPDS was sown by Vijay Kshirsagar, Founder & President and Dr L Ramaswamy, General Secretary, Sotax India. SPDS will impart knowledge and training by organising a number of high quality, value-added workshops and seminars that will help pharmaceutical industry professionals and academia to improve their knowledge and skill sets. This will result in much better on-job performance and efficiency. SPDS will work in close tandem with colleges, universities, other professional and regulatory bodies related to the pharmaceutical industry in an effort to update PhD scholars, post-graduates and pharmacy students through training and workshops to provide a better understanding of the sophisticated modern dissolution systems, equipment and software.

Plans are also underway at SPDS to make a web portal. This interactive website acts as a source of knowledge. One can post queries or issues in the arena of dissolution, methods, developments and more. A panel of experts will address all inquiries and offer solutions to the same. The society is also planning a comprehensive e-journal that will feature articles from society members as well as industry professionals. Besides, SPDS will organise workshops, seminars, events both nationally and regionally. Disso India 2013 will be an Annual International Convention to be first held in Mumbai in May 2013. This event will be organised under the Chairmanship of renowned Dr Vinay G Nayak, President-Technical, Alembic Pharmaceuticals Ltd and the Organising Secretary; Dr L Ramaswamy, MD, Sotax India Pvt Ltd.

Aurobindo receives USFDA approval for ondansetron Aurobindo Pharma Ltd has received final approvals from the USFDA to manufacture and market ondansetron injection USP 2 rng/ml packaged in 40 mg/20 ml multiple-dose vials (ANDA 202599) and ondansetron injection USP 2 mg/ml packaged in 4 mg/2 ml single-dose vials, preservative-free (ANDA 202600).

The products are ready for launch. The approved ondansetron injections are the generic equivalent of GlaxoSmithKline’s Zofran® injection and indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or postoperative nausea and/or vomiting.

These are the first ANDAs to be approved out of unit IV formulation facility in Hyderabad, India for manufacturing general liquid injectable and ophthalmic products and will be marketed and sold by Aurobindo’s wholly owned subsidiary AuroMedics Pharma LLC.

In Brief Roche receives FDA approval for Tamiflu

Roche received FDA approval for Tamiflu to cure influenza in infants, as the agency extended the Tamiflu (oseltamivir phosphate) approval. The approval makes Tamiflu the only prescription oral antiviral FDA-approved drug to cure patients of all age groups. Tamiflu was first approved in the United States over 13 years ago. Globally, around 30 million children older than a year, including about 6.9 million children alone in the US, have been prescribed for Tamiflu. Hal Barron, Head - Global Product Development and Chief Medical Officer, Roche said, “We are very pleased that this approval provides parents with a medicine for children as young as two weeks old, particularly because the Centers for Disease Control advises against vaccinating infants less than six months of age.”

New tuberculosis drug trial begins in South Africa

Case Western Reserve University School of Medicine and AstraZeneca, a global biopharmaceutical company, have announced the first patient enrolled in a phase IIa trial to assess the effectiveness of AZD5847, a new test drug for patients with Tuberculosis (TB), including patients with HIV co-infection. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health. It is being conducted by the NIAIDsupported Tuberculosis Research Unit of Case Western University School of Medicine of Cleveland, Ohio, and is taking place in Cape Town, South Africa with TASK Applied Science, a South African clinical research group that specialises in TB trials. “New medications are greatly needed to improve and shorten the treatment of TB in high-burden countries,” said John L Johnson, Professor of Medicine - Division of Infectious Diseases and HIV Medicine, Case Western Reserve School of Medicine and Staff Physician, University Hospitals Case Medicine Center. “This trial is the first step in testing this new potential drug in humans with active TB.” “AZD5847 is one part of AstraZeneca’s ongoing commitment to conducting research and collaborating across industry, academia and government to develop novel treatments for TB and help stop the spread of the disease,” said Manos Perros, Head-Infection Innovative Medicines Unit, AstraZeneca. “AstraZeneca’s intent is to work with partners to test the contribution of AZD5847 in further clinical trials as part of one or more next-generation combination therapies,” added Perros.

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Mo d er n P har ma•1 - 15 J anuar y 2 013

News, Views & Analysis

China takes over Indian Caraco completes offer to acquire Dusa Pharma vaccine makers

After taking on Indian pharma sector’s API makers, China is now showing its rage on India’s vaccine industry. Currently, the low-cost Indian vaccine industry exports vaccines to 150 countries and produces 40-70 per cent of the WHO demand for DPT and BCG vaccines and 90 per cent of measles vaccines. “China has come up with much larger capacity units, which is a big worry for the entrepreneur-driven Indian vaccine sector. Unless the government comes forward to help Indian vaccine makers with capacity building by offering funds at affordable interest rates, adequate power supply and infrastructure Indian vaccine makers will not be able to meet the Chinese challenge,” Dr P V Appaji, Director General, Pharmexcil said. Talking about the ongoing power crisis in Andhra

Pradesh, Dr Appaji said that power shortages resulted in an over 5 per cent rise in operating costs for pharma units in the state, which was something the small and medium players could ill afford. Meanwhile, Dr Appaji said that Pharmexcil had identified new exports markets for Indian pharma players like Latin America and Africa and that the focus now was on getting more Indian pharma units to upgrade their units to WHO-GMP and WHO prequalification standards, focus on product development and patents as well as sharpen focus on biotechnology and biosimilars. “BT and bio-similars will be the future of the healthcare industry over the next 5 years or so,” Dr Appaji added. He also pointed out that the Indian pharma exports target of hitting the $ 25 billion mark by 2014 had now been revised to 2015 due to the impact of the international meltdown.

Drug firm Sun Pharmaceutical Industries’ US-based subsidiary Caraco has successfully completed the tender offer to acquire Dusa Pharmaceuticals. The company said after the tender offer’s expiration, 2,09,46,624 shares of common stock of Dusa had been validly tendered, representing nearly 82.4 per cent of the outstanding shares of Dusa, Sun Pharma said in a statement. In November, Sun Pharma had inked a pact to acquire US-based Dusa

Pharmaceuticals for around 230 million (around ` 1,250 crore). Under the terms of the agreement, Caraco had to commence a tender offer for all of the outstanding common stock of Dusa at a price of $ 8 per share in cash, a 38 per cent premium to the closing price of Dusa’s common stock on November 7, 2012. “Caraco Pharmaceutical Laboratories (CPL) intends to promptly move forward with a short-form merger under New Jersey law after exercising

its top-up option under the merger agreement, and Dusa will become a wholly owned subsidiary of CPL,” it said. The company said the shares, which were not tendered during the offer would be cancelled and cease to exist. The shares would be ‘converted into the right to receive the same $ 8 per share in cash paid in the tender offer.’ “Following the merger, Dusa’s common stock will cease to be traded on the NASDAQ global market,” it added.

USP to conduct workshop on microbiological control in March 2013

The prevention and control of microbial contamination are critical for manufacturers of pharma and health-related products. Raw material quality, water, manufacturing environments and personnel are some of the main factors that can contribute to potential contamination issues. More recently, microbiological contamination linked to

compounded sterile injections of a steroid drug has been the centre of an ongoing tragedy in the US, which has resulted in more than 35 patient deaths and has prompted heightened awareness among US lawmakers about preventing similar situations from occurring in the future. In March 2013, the US Pharmacopeial Convention

(USP) will host a workshop on microbiological control in the manufacture of pharmaceutical products, which include both sterile (eg, parenteral drugs) and non-sterile (eg, solid oral dosage forms) medicines. USP is not responsible for enforcing the standards. Enforcement is a responsibility of the US FDA.

Abbott launches its BVS in India

Abbott has launched world’s first drug eluting Bioresorbable Vascular Scaffold (BVS) in India. Abbott’s BVS is a firstof-its-kind device for the treatment of Coronary Artery Disease (CAD). It works by restoring blood flow to the heart similar to a metallic stent, but then dissolves into the body over time, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic stent. Abbott’s BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. The launch of Abbott’s BVS is supported by a clinical trial programme that encompasses five studies in more than 20 countries around the world, including India. BVS has been studied in Indian population and has shown robust clinical results. “BVS is a leading example of Abbott’s commitment to innovation – from the initial device developed nearly 10 years ago to the expansion of our manufacturing capabilities to support this launch,” said Amit Kumar, Regional Director and General Manager, South Asia and Southeast Asia, Abbott.


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

News, Views & Analysis

Novartis obtains FDA clearance for Signifor ® Novartis has obtained FDA clearance Signifor® (pasireotide) injection for use in Cushing’s disease adult patients for whom pituitary surgery may not be a suitable alternative. Signifor® is the first drug that received approval in the US, which addresses the underlying mechanism of Cushing’s disorder that is a serious, debilitating endocrine disease induced by the development of a non-cancerous pituitary

tumor leading to excess cortisol in the body. This clearance follows a unanimous recommendation from the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) for using Signifor®. Hervé Hoppenot, President, Novartis Oncology, informed, “The FDA approval of Signifor® for Cushing’s disease brings a novel pituitary-directed therapy to patients with limited

treatment options. Today’s milestone reinforces Novartis’ commitment to addressing unmet needs and advancing treatments for rare pituitaryrelated disorders.”

“Patients with Cushing’s disease may suffer from debilitating manifestations, and there are many serious health complications associated with the disease. The FDA approval of Signifor® offers the option of a medical therapy that may help certain patients with Cushing’s disease,” commented Mary Andrews, CEO and Co-Founder of the US non-profit, The MAGIC Foundation.

Cushing’s disease generally affects adults between 20 to 50 years of age with three times more prevalence in women over men. Common symptoms include weight gain, severe fatigue and weakness, central obesity, red full face, striae, high blood pressure, anxiety and depression. Cushing’s disease may lead to severe illness and death with more than four times higher mortality rates in the healthy population.

Gerresheimer acquires majority stake in Triveni Polymers Gerresheimer AG, a major global partner in healthcare and pharma sector, has acquired the majority interests in Triveni Polymers Ltd, a leading Indian supplier of plastic containers and closures in pharmaceutical industry. Subsequent to the deal, Gerresheimer is now looking at expanding its footprint

in Indian market. Post acquisition, Gerresheimer will own 75 per cent interest in the company, while remaining stake will be held by Triveni. Subodh Gupta will continue to manage the Indian operation. Speaking on the development, Hans-Jürgen Wiecha, CFO, Gerresheimer

Merial to acquire the animal health division of Dosch in India

Barella

Merial, the animal health division of Sanofi, has entered into a binding agreement to acquire the animal health division of the Indian company Dosch Pharmaceuticals Pvt Ltd, creating a market entry for Merial in that country’s strategically important and growing animal health sector. The agreement is subject to regulatory approval and is expected to finalise by the first half of 2013. Financial details were not disclosed. “The acquisition of Dosch’s Animal Health Division will be a significant milestone for Merial and give us a strategic platform for our development in the Indian market,” said Jose Barella, CEO, Merial. “We are convinced that the combination of Dosch’s animal health brands and distribution strength, along with the robust new product pipelines from both Merial and Dosch, will strongly position Merial to become rapidly a major animal health player in India.” “The strong nationwide sales, marketing and distribution network of Dosch, along with established products and people will be an ideal platform for Merial to enter the fast developing animal health market of India,” said Sanjay Doshi, CMD, Dosch. “Merial’s entry will further strengthen the existing offering of Dosch’s animal health business and provide a larger canvas for the market and the Dosch team.”

Gerresheimer will own 75 per cent interest in the company, while remaining stake will be held by Triveni.

said, “This acquisition is well aligned to our strategy of enhancing our footprint in the emerging markets. Triveni is a leading and fast growing company with excellent profitability that provides high value for us. Our global expertise combined with the excellent local manufacturing

capabilities of Triveni will speed up our growth in the emerging countries.” Subodh Gupta, MD, Triveni Polymers, commented, “Triveni’s product portfolio ideally complements Gerresheimer’s plastic packaging range and will enable us to better support our customers in their business.”

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News, Views & Analysis

Sathguru to deliver biosafety management programme from January 21 - 23 Sathguru Management Consultants and the College of Agriculture and Life Sciences, Cornell University, Ithaca is all set to facilitate the ’Global Biosafety Management Programme,’ an intensive threeday training from January 21 to 23, 2013 at Hyderabad. The programme comprises a series of interactive lectures, panel discussions, case studies and project presentations with participation from industry, government bodies and research institutions from India, USA, Europe, ASEAN and Africa. The programme will witness the convergence of an eminent faculty comprising industry leaders and subject experts from around the globe who will share their knowledge and experiences through relevant case studies, lectures, group assignments and discussion sessions. “The programme is designed to address the various aspects of safety assessment of transgenic product

development; contemporary international programmes, and technologies and their impact on other resources, with biosafety regulations; issues on transgenic expertise, towards building a trait management; cross-border consensus and encouraging research partnerships; bio- the culture of collective property access and technology responsibility and cooperation transfer and other socio-economic to promote biosafety and and policy frameworks. I strongly biosecurity around the globe. feel that agricultural biotechnology A balanced and effective and transgenic research should approach to global biosafety lead to economic can be achieved only by recognisng empowerment of the many viewpoints farmers through and approaches better productivity to biosafety. The and consumer programme will satisfaction. At highlight the the same time, importance of an continued effort effective regulatory for better products system that will should lead to ensure the safety of rural employment Vijayaraghavan the procedures and of the agricultural community,” s a i d products of transgenic and K V i j a y a r a g h a v a n , biotech research, and discuss Chairman, Sathguru modern approaches to biosafety, Management Consultants. and try to address pathways The question at hand is How that will result in a balanced to leverage the many existing solution that may have wider global biosafety associations, applicability on a global scale.

Thermo Fisher Scientific introduces next generation centrifuge series Thermo Fisher Scientific Inc, the world leader in serving science, has launched the Thermo Scientific Sorvall LYNX superspeed centrifuge series, delivering productivity, safety and reliability to maximise everyday centrifuge use in shared laboratory settings. The Thermo Scientific Sorvall LYNX centrifuge features a 100,000x g top speed performance and supports highthroughput sample processing from 50 mL conical tubes and microplates to 1 L bottles, up to a 6 L capacity, meeting the evolving needs of academic research and production facilities alike. Run set-up is easy with the intuitive touchscreen interface featuring a bright, highly visible and durable display, while on-board video tutorials and access controls, such as user

login with password protection, provide advanced training and programing options. “Today’s researchers require centrifuge performance that is simplified, to accommodate the reality that labs have multiple users with different experience levels and a variety of processing requirements,” said Maurizio Merli, Global Product Director Centrifugation, Thermo Fisher Scientific. “Our new Sorvall LYNX superspeed centrifuges dramatically simplify high-speed centrifuges while increasing user safety and peace of mind. We accomplish this with breakthrough technology advancements, such as the Auto-Lock rotor exchange, Auto-ID instant rotor identification and carbon fibre rotors.”

Marchesini unveils new packaging solutions for pre-filled syringes

Marchesini Group recently presented a complete and innovative line for packaging pre-filled syringes, from assembly through to bundle overwrapping. The line handles a glass syringe with assembled needle, protected by a plastic tamper-evident cover. The needle is pre-assembled by machine model Corima APS2-Combi where the syringes received from the inspection machine are conveyed with a no-contact technology and loaded on the central carousel. The plunger is inserted and screwed in position; afterwards the syringe is transferred to the next turntable to be inserted in a plastic cylinder that is prefed to the machine. In the station after that where the syringe is inserted in the cylinder, again on a star-wheel, the cap is inserted and pressed on. On the machine outlet, the syringe is sealed inside its container and sent to the infeed of the cartoning machine MA320. The infeed system consists of two units of Marchesini’s robotic solution ‘Robocombi’. The first Robocombi installed after Corima’s assembling machine picks up the cylinders with the syringes inside and places them on a positive-motion bucket conveyor belt, in alternated direction, namely with the caps turned by 180°. Marchesini is able to offer lines for the primary and secondary packaging of pre-filled syringes and with speeds of up to 400 pieces per minute.


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Newsmakers of 2012 Pfizer’s initiative to prevent pneumococcal disease in infants and young children

(January) Pfizer Inc entered into a second supply agreement, to broaden and extend the duration of the company’s commitment to help protect infants and young children in the developing world from pneumococcal disease - the leading cause of vaccine-preventable death in young children. The agreements for supply of pneumococcal vaccines was financed by GAVI, five donor countries - Italy, the United Kingdom, Canada, the Russian Federation, Norway - and the Bill and Melinda Gates Foundation.

‘SevenSeaS® Original’ all set to sail under Merck in India

(January) The Indian consumer healthcare division of Merck KGaA, the world’s oldest pharma and chemical company, made a strong impact in the Indian nutritional supplement market with SevenSeaS® Original pure vitamin rich cod liver oil; currently the leader in the vitamin segment in over 100 countries. SevenSeaS® Original is the purest form of cod liver oil; retaining all its natural nutrients, and one of the most trusted natural sources of vitamins A and D.

Dr K Anji Reddy honoured with Lifetime Achievement award (March)

Dr K Anji Reddy, Founder and Chairman, Dr Reddy’s Laboratories Ltd, was honoured with the Lifetime Achievement in Health Award in the Asian Voice Political & Public Life Awards for 2012 at London for his lifetime commitment to medical research and improving the lives of others. Voted by a committee of Members of Parliament in Britain, this award was an annual event hosted by The Asian Voice, a weekly.

Abbott inaugurated first nutrition R&D centre in India in collaboration with Syngene (June)

Abbott inaugurated its first nutrition R&D centre in the country in collaboration with Syngene. The Abbott Nutrition R&D centre was inaugurated by Dr Sam Pitroda, Advisor to the Prime Minister of India on Public Information Infrastructure and Innovations and Chairman of the National Innovation Council. The state-of-the-art R&D centre focusses on the development of science-based, affordable nutrition products for the country and enable the expansion of Abbott’s nutrition product portfolio. More than 50 researchers and scientists are based at the Abbott Nutrition R&D Centre in India at Biocon Park in Bengaluru. Among the products being developed for the Indian market are meal complements for diabetics and pre-diabetics.

Susheel Umesh appointed as Head - Pharmaceutical Commercial Operations, India for Sanofi (February)

Aventis Pharma Ltd (Sanofi Group) appointed Susheel Umesh as Head - Pharmaceutical Commercial Operations, India. He took over the overall commercial responsibility for the Indian pharmaceutical operations including tier II operations, mass therapies as well as business excellence and strategy for the consolidated commercial organisation. These responsibilities are in addition to that of diabetes and tier I, which he had been previously managing as Senior Director – Commercial Operations since August 2010.

Ranbaxy opens manufacturing facility in Morocco (March)

Ranbaxy Morocco announced the opening of its new manufacturing facility at Casablanca, Morocco, paving the way for a direct business presence in North Africa. With the successful audit of the facility by the Moroccan Health Authorities, Ranbaxy Morocco was authorised to commence manufacturing of its products at its Casablanca facility. The achievement of this milestone positioned Ranbaxy to access a $1 billion pharmaceutical market in Morocco.

Indoco in pact with DSM for Austrian market

(February) Indoco Remedies entered into a marketing pact with DSM Pharmaceutical Products (DPP) NV to sell its products in Austria and other international markets. “DPP will market and sell eight APIs and APIs manufactured by Indoco in Austria and other international markets. The Mumbai-based company has a portfolio of 135 products in various therapeutic segments such as diabetes, cardiovascular, central nervous system, musculo-skeletal, nutrition and dental care.

Ranbaxy launches anti-malarial drug Synriam (May)

Ranbaxy launched the drug Synriam, which it claims will prove a more efficient and simpler treatment for malaria. It is the first recently developed anti-malarial that is not based on artemisinin, one of the most effective treatments for malaria, which has begun to suffer from problems with resistance in recent years. Ranbaxy has hailed Synriam as India’s first domestically developed drug - although none of its active ingredients were discovered in the country. Ranbaxy developed Synriam as a fixed-dose combination of arterolane maleate and piperaquine phosphate, where arterolane is the NCE that was developed as an alternative to artemisinin. Synriam was produced as a combination therapy to follow WHO guidelines on delaying the appearance of drug resistance.

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Cipla announces breakthrough price reduction on cancer drugs

(May) Cipla Ltd announced a breakthrough price reduction in selected cancer drugs for the treatment of lung cancer; Hepatocellular Carcinoma (HCC), a form of liver cancer; Renal Cellular Carcinoma (RCC), a form of kidney cancer; and Glioma, a deadly form of brain cancer. Cipla’s brand ‘Soranib’ (Sorafenib) for the treatment of HCC & RCC will now be off ered to cancer patients at a price of ` 6,840 for a month’s therapy. This comes as a boon for patients with a 76 per cent reduction from the current cost of ` 28,000. “This initiative of price reduction is a humanitarian approach by Cipla to support cancer patients” commented Dr Y K Hamied, CMD, Cipla Ltd.

Mylan partners with UN and CHAI (May)

Mylan Laboratories Ltd, the Indian subsidiary of Mylan Inc, announced its partnership with the UN’s Millennium Development Goals Health Alliance (MDGHA) and the Clinton Health Access Initiative (CHAI) to fight childhood deaths caused by diarrhoea. Mylan announced that it would develop and expand access for needy children across the country. Anirudh Deshpande, Senior Vice President, Business Development, Mylan Laboratories in India, said, “At Mylan, we are committed to increasing access to these affordable treatments to the children of India and those in the rest of the world. We share the concerns of organisations such as MDGHA and CHAI about expanding access to these lifesaving medicines.”


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Newsmakers of 2012 Bharat Biotech received $ 4 million from the Wellcome Trust

(July) Bharat Biotech and The University of Maryland Center for Vaccine Development (CVD) received a $ 4-million Strategic Translation Award from The Wellcome Trust for clinical development of a new conjugate vaccine including initial clinical trials beginning in three years to prevent the potentially lethal infectious disease caused by invasive Non-Typhoidal Salmonella (NTS).

Waters expands in India

(July) Waters India, expanded its facility in Bengaluru. The new facility will be approximately 16,000 square feet in floor space. The company invested an approximate amount of ` 2 million. Besides this, the labs in Mumbai, Delhi and Hyderabad will also undergo an expansion in the future.

GSK, HGS reach $ 3.6 billion deal (August)

Glaxosmithkline (GSK) plc and Human Genome Sciences (HGS), entered into a definitive agreement under which GSK acquire dHGS for $ 14.25 per share in cash. The transaction values HGS at approximately $ 3.6 billion on an equity basis, or approximately $ 3 billion net of cash and debt, and represents a premium of 99 per cent to the HGS closing price of $ 7.17 per share on April 18, 2012, the last day of trading before HGS publicly disclosed GSK’s initial private offer.

Pharma industry pegged to grow to $ 60 billion by end of 12th Plan

(September) UR Associates in its report on pharma sector stated that the overall pharma industry was pegged at ` 1000 billion with the domestic pharma industry at over ` 600 billion in 200910. The Indian pharma industry accounts for 20 per cent of the global generics industry. During the 11th Plan, the domestic market grew at 14 per cent CAGR and exports grew at 19 per cent CAGR with anti-infective, anti-asthmatic and antihypertensive being the major therapeutic categories.

Biocon honoured (November)

Biocon Ltd received global recognition from the ‘Science’ magazine that featured Biocon in its annual global ‘Top Twenty Employer’ list for the biopharma sector. According to the 2012 Top Biotech and Pharma Employers survey, Biocon was ranked at number 19. Biocon was the only Asian Company to be a part of the top 20 elite list. This company has been ranked on six key parameters such as innovative leader in the industry, with respect, are socially responsible, has loyal employees, does important quality research, makes changes needed.

IAIA elects new team (November)

Indian Analytical Instruments Association elected new executive member committee. K V Venugopalan was elected as the new President, who is also the President of Waters India Pvt Ltd; while C Ravindranath and Dr Ashes Ganguly took over as Vice President. New IAIA secretary position was held by Gautam Rajan, existing MD of Marsap Services Pvt Ltd; Vipul Chhatbar, the acting MD of MEDISPEC INDIA LTD and BioTek Instruments (I) Pvt Ltd was the new Treasurer for IAIA. Current CEO Skytech Systems India Pvt Ltd will take over as Joint Treasurer. IAIA team comprises total 78 members, including 59 corporate life members and 19 individual life members.

Pharma industry appealed against bar coding norms (December)

The pharma industry urged the Union Ministry of Commerce for withdrawing the regulations on pharmaceutical exports. A verdict on this issue has been pending from Madras High Court’s end. The pharma sector is opposed to the norms stating that these would bring in economic and logistical misbalances in trade. The fresh norms require bar-coding on all levels of the formulation packs on pharma products. However, it is becoming a strain for most manufacturers to list all required information on packs that fail to come under the standard sizes. The Ministry of Commerce has implemented the initial phase for barcoding products under these regulations since October 2011. However, the further phases are yet to be implemented.

Indegene acquired Aptilon (December)

Indegene, signed an agreement to acquire the multichannel, video and e-detailing and physician marketing services business of Aptilon Holdings Inc, a wholly owned subsidiary of Aptilon Corporation. The need for intelligent, robust and outcome-driven Multi-Channel Marketing (MCM) and virtual/ inside sales programmes is estimated to represent a $ 10 billion opportunity as companies continue to accelerate the transformation of their sales and marketing organisations over the next 4-5 years.

Bilcare sells global clinical supplies biz for ` 340 crore

(September) BILCARE Ltd sold its global clinical supplies business in the US and UK for $ 61 million (around ` 340 crore) to Irelandbased United Drug Plc. The agreement allowed Bilcare GCS Asia to leverage United Drug’s deep capabilities and resources in the US and Europe. Further Bilcare GCS Asia will continue to build scale by being able to service the Asia specific needs of United Drug’s customers in US and Europe, Bilcare said.

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Johnson & Johnson launched OTC congestion relief syrup (August)

J&J announced the launch of its new congestion relief variant Benadryl® Congestion Relief that helps expectoration of cough with phlegm or wet cough and relieve chest congestion. Tushar Murdeshwar, VP - Marketing, Consumer Division, Johnson & Johnson Ltd, said, “Benadryl® is an iconic brand with a strong heritage within our portfolio. It presents a tremendous growth opportunity for us. With the new variant, Benadryl® plans to expand its range of specialist solutions to treat all types of cough-related ailments with care.”

Indian generics giant wins cancer drug patent case (October)

Cipla scored a landmark court win in a patent challenge launched by Switzerland’s Roche Holding over the Mumbai firm’s version of a lung cancer drug. Delhi High Court Justice Manmohan Singh ruled that Cipla’s drug, Erlocip, did not violate the Roche patent on its anti-lung cancer medication Tarceva due to its different molecular make-up. “It is a landmark judgment in a patent case. The court has taken all efforts to analyse claims of both parties in terms of legality and scientific evidence,” said Pratibha Singh, a patent lawyer who represented Cipla.

Government approves eight foreign pharma investments

(October) INDIA approved eight foreign investments in drugmakers worth $ 333 million in total, signalling the finance ministry may be winning a battle to open up the country’s fast growing markets and giving a boost to global drugmakers hungry for growth. However, the government said the foreign companies including US-based Pfizer and Germany’s B-Braun would have to continue producing cheap drugs and maintain spending in ongoing R&D projects run by their Indian partners for 5 years.


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Mo d er n P har ma•1 - 15 J anuar y 2 013

In Conversation With

Commitment and sincerity are the two ingredients for a successful professional and personal life Nikunj Sharma nikunj.kumar@network18publishing.com

Spectroscopy and chromatography are guided by the term ‘precision’; how important is this word for marketing these devices? Precision or accuracy is extremely important in the field of medicine. The history of precision medical instruments can be traced back to the seventeenth century when they were used for the first time. Medical instruments are recognised as objects and tools with many different medical purposes including prevention, monitoring, diagnosis, therapy, treatment or alleviation of diseases. Companies today are leveraging on renewable and sustainable energy, remote patient monitoring, combination devices and medical robotics allowing high-precision surgery to revolutionise healthcare in ways more than one. How do you visualise the changing trends in India and neighbouring markets? Hospitals, doctors and medical equipment firms have called for digitisation of healthcare industry and standardisation of procedures. Healthcare also has started to move from hospitals to home. For patients this means easier access to healthcare, fewer hospital visits and reduced medical costs. Much of today’s medical development is targetted at bed side monitoring. These devices directly can be made useful in the implementation of a generation of affordable solutions for self-use at home or by semi-trained staff at neighbourhood clinics or rural locations. These consumer devices, coupled with quality sensors and data acquisition devices would result in medical-grade systems that can be readily deployed at a fraction of the cost of high-end equipment used in hospitals. Provide a comparative landscape of growth in demand for analytical and measurement instruments in terms of institutional and industry sales perspective. With the increasing export of generic drugs, processed food etc, there is a constant need to improve the quality output. Apart from this, enhanced regulatory environment and introduction of new food law, it is important to use highend precision equipment to

meet this demand and hence need for such equipment. Most of the analytical instrument providers are represented directly in India. In the next foreseeable future, there would be high demand for these products in India and neighbouring countries. Technology is an area that grows with continuous innovation; how does Agilent manage to stay ahead of times? Agilent Technologies is the world’s premier test and measurement company. It works in close collaboration with engineers, scientists and researchers around the globe to meet the communications, electronics, life sciences and chemical analysis challenges of today and tomorrow. Agilent’s bio-analytical measurement business provides applicationfocussed solutions that include instruments, software, consumables and services that enable customers to identify, quantify and analyse the physical and biological properties of substances and products. What are the challenges you face during regular practice? There are several but I would like to mention three major problems here: Keeping up with technology: One of the biggest challenges we face is to keep up with the technology. Everyday technology is changing and we need to keep up with the pace. Equipment to enable quick prototyping: Another challenge faced by the design engineers at various stages of design is the need for quick prototyping. Always it is not possible to have ‘golden’ boards or sub-systems that can be used to validate a newly developed sub-system. Thus arises the need for a platform, which enables users to prototype quickly the various sub-systems and test the development done by the user. Test equipment that ensures shorter design cycle: The most critical challenge we face is reducing the design cycle and coming up with accurate equipment. Are robot-assisted devices on your cards? Agilent Technology has a portfolio of robot-assisted devices. Some of the products we have in this field are – BenchBot robot: With the BenchBot robot, automated solutions move from large, specialised machines to

…says Dr Siva Kumar Pasupathy, Country Business Head - Life Science and Chemical Analysis Group, Agilent Technologies, India. The ‘precision’ scientist with exceptional in-built leadership qualities, discusses the analytical instrument market, future innovation trends and India’s status vis-a-vis global standards.

compact, flexible robots that any scientist can use. The power of the BenchBot comes from its flexibility, accessibility and ease of use. Some of its features include compact size, unique one–touch programming, four-axes of motion and open design for easy integration.

As part of the emerging markets, India is a prime target country and we will focus on investments in line with the growth trajectory. Microplate centrifuge: The Agilent Microplate centrifuge offers stable high-speed centrifugation for 3-second cycle times. The Microplate centrifuge is a small robotaccessible automated centrifuge that provides both vibration and noise control in a small, low-maintenance package. Ideal for high- or mediumthroughput applications such as PCR purification, cell harvesting and air bubble removal in high-density microplates, the Microplate centrifuge is capable of rapid customisable acceleration and deceleration, minimising the

required cycle time. With a 3-second loading time and robust motion control, the Microplate centrifuge can be accessed by most laboratory microplate handlers/robots. GC, HPLC, MS are highly sophisticated instruments; how successful are you in managing the installation training and post-sales service? Use and maintenance of these highly sophisticated analytical instrumentation is key to the success of any laboratory be it a commercial organisation or a research laboratory. Agilent Technologies has established infrastructure to ensure that their customers are able to use instruments effectively and productively. Support is provided not only in terms of service but also applications support and training. With this infrastructure in place, Agilent has built a reputation of providing highest level of support and customer satisfaction. We at Agilent, constantly monitor ‘customer satisfaction score’ and improve on any feedback that is provided by our customers. Kindly give an insight into the technology of future in analytics and measurement? With a focus on improving

quality of life and providing quality products, there is a need for implementing the latest technology. Hence, the demand for such products will be there for several years to come and we see a huge demand for the measurement tools. What led you to sales? Coming from a scientific background (being a scientist myself), I always wanted to provide technological innovation to the utilisation of a common man or that can benefit the common man. One of the routes through which this could be achieved is by selling and marketing these technologies. When I had the opportunity to join a sales organisation promoting healthcare products, I took it up with this objective in mind. Most influencing person and learning of your life? My father has a huge influence on my life. What I liked and adopted from his life has been to be truthful, honest and straight forward. Whatever you have to say, make the point up front rather than talking from behind. This has helped me grow enormously in my professional and personal career. Commitment and sincerity are the two ingredients for a successful professional and personal life. How do you maintain worklife balance? As the responsibilities in your professional career increases, it is very difficult to maintain a reasonable work-life balance. However, it is important to maintain that. By being with the family during the weekends and holidays is one key factor, and secondly take time out with the family once in six months and spend quality time. What is your satisfaction measure: customer’s delight or achieving sales target? The purpose of our existence in a profession like ours is customer. It is essential that we provide the highest level of customer satisfaction. When the customer is satisfied, he will come back and give business and he will be an advocate for our products and company. Hence, customer delight is paramount, which obviously will lead to achieving the results. Any expansion plans within India or other geography? As part of the emerging markets, India is a prime target country and we will focus on investments in line with the growth trajectory.


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

Special Focus

15

The laboratory analytical market

Nikunj Sharma nikunj.kumar@network18publishing.com

D

uring the past few years, the global consumption of analytical instruments has increased, and companies have been displaying keen interest in acquiring advanced devices and penetrating the emerging markets. Major players including GE Analytical Instruments, Agilent Technologies, Thermo Fisher Scientific are looking forward to address the growing demand as well the upcoming opportunity areas in the analytical markets worldwide. The Indian market has registered steady growth in the past five years except the slowdown period, while developed economies took a plunge due to Eurozone crisis in 2012. Giving a brief overview of the segment, Ramesh Datla, MD, ELICO Ltd, Hyderabad, informs, “The laboratory analytical instrument market is India is growing at a rate of 15-20 per cent compared to developed nations’ growth rate of 3-4 per cent. In the Asian region, China and India are emerging as leading marketplaces for analytical instruments. By value proposition, the Indian market stands at ` 4,500 crore against the global market value of over $ 40 billion. The Indian laboratory analytical instrument market is mainly dominated by American companies that accounts for about 60-70 per cent of the total market. In the context of product segment, chromatography systems holds major proportion contributing to 35 to 40 per cent sales revenues followed by spectroscopy and electrochemistry instruments. Thermo Fisher Scientific is the leading player in the segment along with Agilent, Waters and Shimadzu.” The recession period has sparked the need for increased process output and improved competence through decreasing the reporting time, which has enhanced the focus on Process Analytical Technology (PAT). Through PAT, the USFDA has devised a regulatory framework to analyse, design and monitor critical process parameters in a drug manufacturing line, which in turn increases the testing efficiencies and minimises rejection. The trend has allowed pharma companies to reduce the expenditure in repetitive testing procedures and rather divert the investment into quality analytical instruments.

Markets on the other side

According to the US Analytical Instruments Market’s forecast report, globally, the demand for analytical instruments grew during the last few years, and the US market took the leading

Status quo of India and developed countries The laboratory analytical equipment market in India relies mainly on high-end global suppliers for majority of precision instruments. The regulatory compliance, quality adherence and increased government focus on research and testing equipment are expected to drive the market in future. In Asia, India along with China are becoming the prime destinations for significant growth in analytical instrument market as the developed world is heading towards saturation.

Growing collaboration between equipment suppliers, laboratories and distributors is declining the demand for the wholesale lab supply market. Between 2007 and 2012, average margin grew about 8 per cent of total revenue from its 2007 value of 7.8 per cent, due to reduced M&A activity in the sector. The demand for scientific and laboratory supplies will be driven by the downstream sector such as biotechnology and pharmaceuticals. Growth in scientific R&D will result in modest growth over the next five years. However, growing competition in import market and wholesale bypass is expected to affect the profitability and revenue.

The way ahead

position to strengthen the market. Major industry players’ revenue grew significantly due to strict regulations & compliances, high investments and product innovations. Despite economic downturn 2009, the post-recessionary period witnessed increased expenditure from end-user segment. The overall analytical instruments sector for the US is expected to reach $ 7.3 billion through 2014. The major growth drivers include growth in the expenditure patterns of various sectors comprising pharmaceutical, chemicals, oil & gas, food & beverage and electric utilities etc with significant developments in these sectors, the demand for high-end analytical systems will drive the entire market. In addition, the government increased focus on safety among the major concerns across all these sectors. The prominent segments that constitute the US analytical instruments sector comprises liquid analytical instruments,

gas analytical instruments, final control elements, control systems and electronic flowmeters that account for

Four critical factors will increase the sale of analytical equipment market in India including quality, research, regulatory and environmental compliances. Ramesh Datla MD, ELICO Ltd, Hyderabad

about 70 per cent of the overall market. Strict regulatory environment for food and environmental safety, drugs manufacturing and chemical plants are also fuelling the sales of these instruments. According to a research report from Frost & Sullivan, the laboratory analytical instrument market for China is forecast to register a CAGR of 11.4 per cent reaching $ 3.22 billion in 2018 from its 2011 levels of about $ 1.51 billion. The growth trend is attributed to increased governmental support for public health, technologybased services and food safety, which will enhance the demand for laboratory analytical instruments. In addition, major global players are accelerating the domestic production along with the economic growth in the country as well as government focus on educational sector to incorporate new analytical curriculum in colleges and universities.

Amid ups and downs in the market, the regulatory compliance and awareness is growing in India, and the industry is cautiously responding to the trend. Meeting various regulatory compliances and exposure to export market is driving the demand for advance analytical instruments. Datla comments, “The market is driven by three major factors including regulatory compliance; demand from government for soil and water analysis system; and increasing orders from Indian companies for sophisticated analytical solutions. The stringent norms for pharma drug quality compliance and increase in life science research is also fuelling the demand for high-end analytical equipment in India. Witnessing the growth trend of the last 5 years, except recession period in 2009, the lab analytical instrument market is expected to grow at a rate of over 15 per cent. Apart from the industry sector, the academic research institutes will be the major growth driver in this segment. Four critical factors will increase the sale of analytical equipment market in India including quality, research, regulatory and environmental compliances.” Spurring competition among the domestic and global markets is a healthy sign for the growth of analytical instrument sector in India; however, it would be interesting to see how Small- and Medium-sized Businesses (SMBs) and Smalland Medium-sized Enterprises (SMEs) will respond to the trend, as cost will be a major constraint for them. In the middle of all, the contract service organisations are expected to play a significant role in fuelling the demand for these instruments.


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Modern P har m a•1 - 15 J anuar y 2 013

Special Focus

FDI for analytical instruments

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

F

oreign Direct Investment (FDI) can be defined as a cross border investment, where foreign assets are invested into the domestic market excluding the investment in stock. This facilitates in bringing private funds from overseas into products or services. The domestic company in which foreign currency is invested is usually being controlled by the investing foreign company. In the recent past, there had been continuous debates on whether introducing FDI is a welcome move. Ranging from several political parties to different trade organisations, people have voiced their individual opinions. While some believe that introducing FDI will open new job opportunities for Indians, others are of the opinion that this will curb the growth of the existing Indian companies. With a view to take a final decision on relaxing FDI norms in the pharma sector, Prime Minister, Dr Manmohan Singh called meetings of senior ministers, including P Chidambaram, Finance Minister and Anand Sharma, Commerce and Industry Minister. In May 2012, the total FDI in India was down to $ 1.3 billion as compared to $ 4.6 billion for the corresponding period last year. Further, with the GDP growth forecast of 6.5 per cent, the FDI contraction will only add to the inflation.

A hit or miss?

While some disagree with introduction of Foreign Direct Investment (FDI) in retail, others feel that FDI will improve the analytical instruments market of the pharma industry, especially by creating job opportunities. Here’s analysing the pros and cons.

A curvy road ahead?

Application in pharma

In October 2011, a ministerial group headed by Prime Minister, Dr Manmohan Singh had put foreign investment in Brownfield pharma on approval route, changing a 10-year-old policy of automatic clearance. Under this, for any M&A, the overseas investor will have to seek permission from Foreign Investment Promotion Board (FIPB). And it was decided that after six months, Competition Commission of India (CCI) will scrutinise such deals. However, 100 per cent FDI under automatic route is allowed in new projects. The issue of FDI in existing Indian pharma companies started attracting the government’s attention after several MNCs acquired giant Indian companies such as Ranbaxy, Shantha Biotech and Piramal Health Care’s health unit. However, the concern was on another level. While the Finance Ministry wants that only those cases involving FDI beyond 49 per cent in existing units should be considered by FIPB, the Department of Industrial Policy and Promotion (DIPP) wants any foreign investment in existing pharma units to

was apprehension and doubt on how FDI would impact the Indian pharma scene. But with close inspection one realises that the overall impact on Indian pharma scene was not visible/ considerable.” He elaborates, “FDI certainly attracted many MNCs to look at India for more than one reason and with growing interest in India. Probably the government wanted to ensure that FDI should create issues related to the future of Indian pharma companies and affordability etc.” Talking about benefits of introducing FDI in pharma, Dr H G Koshia, Commissioner, Food & Drugs Control Administration, Gujarat, continues, “With FDI, several MNCs are looking forward to consider India as the pharma destination. There have been several mergers in this context too. However, the country’s major concern is whether the mergers as a result of FDI will stunt the growth of the small- and medium-sized industries. Continuing the same line of thought, Dr Ajmani adds, “ This committee is expected to look into all possible situations and make sure that FDI does bring desirable results.”

be approved by the FIPB. Further, DIPP and health ministry had also insisted that foreign companies acquiring Indian firms must seek the

With new system in order, FDI in pharma would be more regulated via a high level committee so that the interest of Indian companies and patients are protected. Dr Ranjeet S Ajmani CEO, Plasmagen Biosciences Pvt Ltd

approval from the government if they decide to reduce or stop manufacturing of essential drugs by the acquired entity. Again, the two ministries want that MNCs acquiring Indian firms should not cut production of generic drugs under any circumstances. There are several dominant Indian players in the market, with major MNC players being Agilent, Thermo Fisher, Labindia, Shimadzu, Waters, Philips, Perkin Elmer, Brucker, Styrich, Varian Elico and Netel. The market also includes many distributors who represent foreign principals such as Spinco Biotech, Toshvin Analytical, Microdevices MetroOhm etc. MNCs are also closely looking at Joint Ventures (JV) or acquiring Indian manufacturers. India has the advantage of cost and expertise, and thus it will be interesting to observe whether FDI will be welcome.

A beneficial move?

Discussing whether introduction of FDI will

be beneficial for the Indian pharma industry, Dr Ranjeet S Ajmani, CEO, Plasmagen Biosciences Pvt Ltd, avers, “Initially, there

The country’s major concern is whether the mergers as a result of FDI will stunt the growth of the smalland medium-sized industries. Dr H G Koshia Commissioner, Food & Drugs Control Administration, Gujarat

Dr Koshia believes that foreign companies provide advantages to Indian companies. Thus, the introduction of FDI will generate employment and therefore have direct impact on the growth of the industry. But there is a constant fear that FDI will ruin the growth opportunities of the existing companies in India. Elaborating on the not-so bright situation that FDI may bring with them, Dr Ajmani explains, “There is a constant fear that FDI may deter the growth curve, as they may not want to travel this path of committee, which may make the process slow and difficult to operate. Also within the system itself, the government has many other ways of controlling the price.” So, now the most relevant question is; how this new proposed process will work, and probably this would determine the level of interest of MNCs in India? However, in a note of offering hope, Dr Koshia assures that unlike the retail industry, the pharmaceutical industry is an extremely organised industry. Thus, the small- and mediumsized companies will not shut down and instead leverage on the growth opportunities.


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

Special Focus: Interface

17

Pharmaceutical companies have fewer resources from which increased productivity is required Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

What are the trends you see in the pharma instrumentation market? How are you tapping them? Today, pharmaceutical companies have fewer resources from which increased productivity is required. Discovering and developing drugs is becoming a progressively expensive and high-risk venture. Consequently, productivity must increase at all stages of the pharma production process, starting from drug discovery, chemical and formulation development to manufacturing. This requires seeking more information on a quicker basis. In turn, this would require higher levels of automation than what is currently deployed Second, in the development of biologics, the industry faces many of the same challenges as it does when dealing with their traditional, small molecule counterparts. This includes escalating development costs, identification of novel targets with unproven therapeutic potential and regulatory agencies demanding more compelling demonstrations of the value of new products. Compared to small molecules, biologics have some distinct attributes that present additional challenges. Their complex structural organisation and delicate conformation render them prone to degradation (proteolysis), unfolding and aggregation. Delivery of a therapeutic entity to the patient, usually as a parenteral, can be additionally demanding, due to their low solubility and subsequent high viscosity. Finally, additional care is required in the manufacturing and packaging of biologics. At all these stages, new and more effective analytical techniques are needed to overcome the additional obstacles for new drug approval. At Malvern, we are investing in the two areas I have identified above. First, in technology, that can be deployed further aross the pharmaceutical enterprise to speed up R&D and provide intelligent automated analysis. Second, we are investing in new measurement technologies specifically for the characterisation of biologics and biologics formulations. What products do you have in the pipeline? Our key focus is to make current technologies easier to use and enable their wider

use. We are also further automating measurement protocols by facilitating sample presentation to the analytical device and/or by combining analytical techniques to enhance analysis workflow. The latter is very much evident in our recently launched Morphologi G3-ID system. With the world-wide shift towards biopharmaceuticals R&D, protein charge, size, mass, molecular weight and polydispersity, among others are key measurement parameters. Malvern’s instruments can already measure size, shape and molecular weight, viscosity and molecular structure, and propensity to aggregate. We have just introduced the Archimedes system, which utilises resonant mass measurement to provide particle counting capability, as well as aggregate mass determination in the critical 50 nm-5 µm range. As our bioscience development initiative proceeds, we expect to see a number of new technologies entering early access programmes in the coming months. How energy efficient are the new equipment? All our systems are manufactured in a facility that is ISO14001 certified. We are committed to a yearby-year improvement in our environmental performance. The energy efficiency of our products is always an integral part of their design and development and we can point to the significantly enhanced energy efficiency of the recently introduced Mastersizer 3000 particle size analyser, compared with its predecessor. We build intelligent systems with energy management functions and look to source the most energy-efficient components possible while delivering the highest level of instrument performance.

We must fully understand what the biopharmaceutical development community needs and demonstrate a nimble approach to product development.

What is your vision for the pharma instrumentation industry? The science workforce is highly skilled and compensated. If Malvern can provide technologies that eliminate or reduce sample preparation,

…believes Paul Davies, Global Business Manager, Malvern Instruments. Here, he sheds light upon the latest and upcoming trends in the pharma instrumentation market.

presentation and analyses, which are repetitive, subjective and time consuming, then this workforce should be free to execute the more creative R&D tasks, thus helping to enhance the much sought after productivity. At Malvern, we believe much value lies in our ability to deliver a wide range of characterisation technologies that can be used to help speed up pharmaceutical and biopharmaceutical development processes. These range from systems that run reliably, unattended, to those that provide information on several key attributes in a single analysis, such as particle size, shape, identity or molecular weight, size and concentration. Their application spans pharmaceutical discovery, development and manufacturing and it is clear that work-flow efficiencies may be achieved when these tools are used in conjunction with one another. What are the challenges you face? Just like the pharmaceutical R&D community, we are keen to seek partnerships in the development and testing of new analytical technologies. By taking a partnership approach to the identification, nurturing and development of these we are meeting head on one of the biggest challenges in areas such as biopharmaceuticals,

where the pace of development is required to be relentless. We must fully understand what the biopharmaceutical development community needs and demonstrate a nimble approach to product development. In order to do this more effectively, we actively seek the involvement of our colleagues within the pharmaceutical industry to help us characterise new technologies by road testing beta versions of new products. This is our equivalent of pre-clinical trials. We put prototype versions of our technologies with those who will ultimately buy them. One growth driver that can change the face of the industry... The switch to biologics is already changing the industry. To a lesser degree, the repurposing or switching of drugs and drug candidates for new indications, and the growth of the generics sector is a continuing trend. Also, the FDA’s stance with respect to Quality by Design (QbD) should mean that measurement of key attributes of developing drug products will be made in a timely manner. This in turn will place demand on the analytical instrument technology developers, such as ourselves, to push the envelope in terms of what we are able to measure and

with greater speed, sensitivity and specificity. Where do you see the pharma instrumentation industry in the next 5 years? We will see existing techniques redesigned for dedicated specific tasks allowing more efficient and effective application throughout the pharmaceutical enterprise. For example, particle size distribution of materials by laser diffraction has become common place in the last decade; this technique is now considered the gold standard ensemble technique for particle size distribution measurement. Its maintanance and use are well documented in both ISO and United States Pharmacopeia monographs. The next step will be to make this technique as portable and easy to use as possible, while ensuring that the data generated are compatible and comparable with current laboratory systems. Second, novel measurement technologies for large molecular entities are much needed. This is much more difficult than improving existing technologies. This will require close partnership with the biopharmaceutical development community and we are very keen to continue our partnerships with this group of scientists worldwide. What according to you was the turning point for the industry? Patent expirations have encouraged the generic pharmaceutical industry to develop formulations of existing active molecules. This has required fast-paced reverse engineering of the myriad molecules that are now out of patent protection. In turn, more thought has been put into how the exploding generic pharmaceutical industry can be regulated and how generic formulations can be developed. The emergence of the FDA’s QbD guidance will only serve to ensure that more measurements are made using better developed analytical techniques. The analytical instrument industry should be able to demonstrate the lifecycle management of its products just as the pharmaceutical industry does for theirs. Also, the migration towards biological molecules by innovator and traditional generic pharmaceutical companies has meant that completely novel technologies will emerge sooner rather than later.


18

Mo d er n P har ma•1 - 15 J anuar y 2 013

Facility Visit

Glenmark Generics Ltd

Leading the ‘hormones’ segment

to check the gases and air being released into the environment such that the population is not exposed to any kind of harmful material. The facility is packed with diesel generator sets to ensure a 100 per cent power back up at the facility. At Glenmark, they have installed Shepherd transformers in order to save energy and use it efficiently. There are special provisions taken for waste management. The waste water being led out of the facility is treated and used for various purposes such as gardening etc.

Employee safety

Glenmark Generics Ltd, a subsidiary of Glenmark Pharmaceuticals Ltd, is one of the largest players in selling hormonesbased generics in the US market. We visit their manufacturing facility at Colvale, Goa that focusses on hormonebased generics.

Shibani Shah Chandreyee.bhaumik@network18publishing.com

G

lenmark Pharmaceuticals Ltd today has evolved as one of the top 25 pharma companies in India. With a product profile that covers the therapeutic areas of dermatology, internal medicine, paediatrics, gynaecology, ENT, cardiology, diabetes and oncology, the company develops drug substances, drug products, New Chemical Entity (NCE)’s and biotechnology-based drugs. In 2008, Glenmark Generics Ltd (GGL) set up a facility within the premises of its existing facility to focus on the production of hormones-based generic drugs. The GGL facility is located at Colvale, Goa. The facility houses separate units for the oral solid dosages plant, the semi-solid plant and the hormones-based drug manufacturing plant. Within the facility premises there is a quality control and administration department and the utilities department.

Hormones-based drug manufacturing plant

Dominating the hormones market

GGL manufactures oral contraceptive in the hormones segment and it is the only Indian company serving the US generics market for hormones. Explaining the footprint of the Indian companies in the US generic market for hormone-based solid dosages, Jalaj Sharma, PresidentOperations, Glenmark Generics, says, “For the last few years, Indian generics players serving the US market are trying to enter the hormones market. A number of Indian companies have submitted ANDAs for hormones, especially oral contraceptive but none have received approval as yet. Hormones manufacturing is a complex process as it has to match the structure and efficacy of the hormone present in the human body. The US FDA has thus been approving FDA facility for hormones slowly and the product approvals are also taking a longer time.” It is currently selling 11 hormones in the US and is the third largest player in the market. In a short span of five years GGL has registered revenues in excess of ` 1,200 crore from the US market alone and it manufactures about 40 million tablets per month. Sharma adds, “Our volume growth has approximately been 18-20 per cent every year and we have almost doubled our capacity in the four years. We started with a small man power of 150 employees and today we have more than 800 employees at the Goa manufacturing facility.”

State-of-the art facility

The hormones plant is spread across 6,300 sq m and is located slightly away from the other units of the facility to avoid cross contamination. The internal layout is designed in a way to allow minimum manual intervention between various manufacturing processes such

Our volume growth has approximately been 18-20 per cent every year and we have almost doubled our capacity in the four years. We started with a small man power of 150 employees and today we have more than 800 employees at the Goa manufacturing facility. Jalaj Sharma President-Operations

as blending, compression etc and transport of the raw materials within the facility is easier. The facility is packed with state-of-the art technology and at every step quality analysis is done to deliver the best to its patients. Following cGMP practices, the raw materials are checked and classified thoroughly before being used. There are separate entry and exit points for raw materials and measures have been taken to allow the entry of raw materials within the manufacturing area through specially designed hoods that allow the entry of foreign particle to minimum. Compressed gas, vacuum and steam being used for the manufacturing process is generated within the facility. Hormones are highly potent molecules and hence measures have been taken to ensure the safety of the environment. Additional filters are installed

Hormone-based drug manufacturing is a complex process since these molecules are highly potent and the occupational exposure limits are low. While dealing with such potent molecules safety of the employees and environment is important for the manufacturer. Hormones directly affect the endocrine system, and hence it is extremely critical to protect the handler of such substances. Bearing this in mind, the employees dealing with such high potent molecules are periodically checked for the hormone level in their body. The hormones plant has a manpower of about 200 people to support the manufacturing process. They are periodically rotated to different processes in order to protect them from the harmful effect of the hormones. A dedicated occupational safety centre is being set up within the facility compound and will provide primary treatment in case of any hazard.

Understanding technicalities

The drugs with hormones contain the active ingredients in small quantities. The dosage of the active ingredient to be administered varies over the period of time and hence the manufacturing process is complex. Since tablets with different dosages of APIs need to be packed within the same strip, the process can get complex and take a longer time. To cut this process short and ensure a user-friendly packaging, GGL has invested in obtaining the manufacturing equipment that can produce the different dosages in one go. It has also obtained a tailor-made packaging machine that can help feed upto four different dosages in one blister pack for one course. Hormone manufacturing is a complex process, especially with oral contraceptives. The oral contraceptives are packed in a strip of 28 tablets and need to be consumed on a daily basis. The complexity of manufacturing oral contraceptives is that across one strip each tablet contains a different dose of the active ingredient of hormone. Hence, for every seventh tablet in the same strip the dosage and the formulation vary. To make this simpler for the patients, the packaging and colour coding of the tablets are done and hence it is critical to ensure that the correct tablet is being packed in the correct blister. Glenmark focusses on producing drugs with increased efficacy and overall equipment efficiency. While doing so it also ensures the safety of its employees and environment. By understanding the technicalities of the process and ensuring the delivery of quality drugs to the highest standards, Glenmark has evolved itself as one of the leaders in the hormones segment. While continually recording tremendous growth since its inception, Glenmark continues to dominate the market through its quality drugs.


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

Insight & Outlook: Automation Trends

19

Software-based automation

Revolutionising pharma manufacturing Software-assisted automation is becoming the need of the hour with growing competition and required adherence to global norms for finished products. Production lines are increasingly de-burdening manual workforce in the quest to deliver an error-free execution of the process. Here’s why the segment is witnessing significant innovative products launches from the software vendors to meet the demand.

Nikunj Sharma nikunj.kumar@network18publishing.com

I

n the past decade, process automation achieved continuous attention and demand from the pharmaceutical manufacturing sector. With the integration of software, automation became more accurate and helped in enhancing synchronisation of all verticals of manufacturing automation, in turn delivering effective utilisation of available resources, enhanced safety, improved product quality as well as minimising the emissions. The sector witnessed automation transformations from mechanical to electronic to digital to robotics, with each transformation inched closer to quality enhancement and error-free production across the globe. Developing nations are increasingly adopting software-based automation for large-scale manufacturing. Dr Arvind Manian, Director, Arasan Chemicals Pvt Ltd, insists,“Software-based automation systems contribute significantly in the area of pharma manufacturing. It could lead

Software-based automation systems could lead to lesser capital costs, efficient control of production parameters, ensuring a high degree of adherence to quality parameters. Dr Arvind Manian Director, Arasan Chemicals Pvt Ltd

to lesser capital costs, efficient control of production parameters, ensuring a high degree of adherence to quality parameters. It thereby reduces waste and also contributes towards more efficient supply chain security, which could lessen the risks of counterfeiting. Such systems could also possibly be tailor made to suit the budgetary and regulatory requirements of a wide range of organisations.”

Enterprise Resource Planning Enterprise Resource Planning (ERP) software offers strict monitoring and control in various processing modes such as mixed-mode or process manufacturing.

These solutions provide useful manufacturing and planning capabilities including composition-based lot integrity and control, comprehensive ECN tracking along with online clearances, batch mode controls with varying batch capacities, multiple-level formula definition and management, multiple-stage yield monitoring, final product lot control and keeping the lot integrity during renumbering or repackaging.

Manufacturing Execution System Manufacturing Execution System (MES) offers improved controls and

co-ordination across the production line including manufacturing elements, equipment, material, personnel, procedures and specifications for facilities and operation areas within a plant. Various MES modules comprise production order management, product definition management, plant performance analysis, materials management, laboratory information management, detailed production scheduling, quality assurance and reporting. Recently, Dr. Reddy’s Laboratories installed Werum Software & Systems’ MES PAS-X at its Bachupally, Hyderabad-based plant in January 2012, for optimising the production across pharmaceutical shop floor operations.

Products on roll ProcessPro® Premier ProcessPro® Premier enables companies to fulfill specific needs through an array of tools to help pharmaceutical organisation in FDA validation, audits apart from meeting 21CFR Part 11 electronic signature compliance.

SOLOCHAIN™ MES SOLOCHAIN™ MES is a portable instrument that combines different mobile technologies, to deliver real-time information about material movement to the manufacturing floor. Features of SOLOCHAIN™ MES include shop floor control, recall management, integrating production and warehouse functions and real-time quality control.

Robotics: The way ahead Robotics is surely the technology of future for pharmaceutical manufacturing; right from R&D to improve throughputs to reduce time to market, and in turn helps decrease the cost of drugs. By 2015, the developers of robotics systems are focussing on building flexible systems, with a view to reduce the capital equipment cost. Robots assistance in ever-growing complex pharmaceutical operations will ensure precision and speed in the sector. The robotics also offers potential applications in R&D activities.


M od er n P har m a•1 - 15 J anuar y 2 013

20 Insight & Outlook: Roundtable

Should patented drugs be price controlled? Arshia Khan arshia.khan@network18publishing.com

K V Subramaniam

Leena Menghaney

President and CEO, Reliance Life Sciences

India Manager for MSF Campaign for Access to Essential Medicines One of the key legal flexibilities available to governments such as India under WTO’s TRIPS agreement is to regulate and control the prices of patent medicines in their domestic markets and for public procurement. However, ironically the most expensive medicines in the Indian market - branded patented products are free of price controls, while increasing number of branded generics are being brought back under price control with the pro-active intervention of the Supreme Court under a public interest litigation. Majority of patented drugs for HIV, hepatitis, cancer, diabetes and other diseases are mostly imported into India by multinational pharma companies. No Patented generic versions are available in the country. One of the immediate ways in which these imported and products currently expensive drugs can be made more affordable contribute less than even is to impose price controls. However, using a loophole in the Drugs Price Control Order 1 per cent share of the total (DPCO) companies are arguing that the Indian pharma market by value. National Pharmaceutical Pricing Authority (NPPA) has no right to ask for cost data Accessibility of these drugs is not an related to imported medicines. Therefore, the issue in the country. NPPA has to accept whatever obscene landed Experts discuss whether price cost the importers choose to declare. At this point the legal reform of the DPCO controlling these initiated by the Department of Pharmaceuticals to drugs will help? include branded patented products could increase pressure on multinational pharmaceutical companies to price their imported products based on actual cost collected by the NPPA from the companies. In the absence of such reforms branded imported medicines like dasatinib (trade name Sprycel) and trastuzumab (trade name Herceptin) will be continued to be sold in the Indian market for over ` 2000 per pill (70 mg) and ` 90,000 per vial. Unfortunately, Indian patients will continue to pay the price for outdated policies of the DoP.

Just because a drug is patented, it should not be kept out of the purview of price control. But, whether a particular drug has to be under price control or not depends on the specific context. On one hand, price control on patented drugs is a big disincentive for innovation. It would make the domestic pharmaceutical companies wary of new drug development and may result in MNCs placing India lower down in marketing priorities. On the other hand, price control may be necessary in public interest. It may also result in innovation being frugal given that many pharma companies leave drug development costs unbridled and believe they can be recovered through high product pricing. The question then boils down to what qualifies as public interest. To my mind, drugs that either address unmet medical needs specific to our country’s context or address public health problems would qualify. How does one then strike a balance between providing the impetus for innovation in novel drug development and meeting the needs of affordable therapies? One way would be to have drugs developed with some level of public funding, in government research labs or private organisations, subject to price control. Another way would be to have price control for government institution supplies combined with free pricing for trade, subject to checks and balances to prevent product leakages between these two segments that could happen in a dual pricing context. A third way would be to provide incentives for manufacturing the drug within the country in consideration for price control. Inherent in these suggestions is the spirit of partnership between the innovator and the government and not treating price control as a unilateral policy measure. In summary, price control on patented drugs can dampen innovation, but, at the same time, may be necessary in public interest and support frugal innovation. A balance has to be struck through a spirit of partnership with measures that can mitigate the economic impact.

Anil Kamath Tapan Ray

Director General, OPPI Patented products tend to be unique in their mechanism of action, ability to arrest the progress of diseases and ensure significant improvement in quality of life. These drugs have other multiplier effects that can be passed on to patients through savings brought on by reduced hospitalisation costs and doctors’ fees. Patents act as an incentive to trigger innovation and open markets will ensure that drug companies recover part of their investment costs. About 30 new drugs have been patented in India since it started granting patents to pharmaceutical products. So far, around 20 of these products have been launched with the rest still under development. The majority of these products launched in India have generic therapeutic equivalents available at a lower price. Innovator companies follow varying approaches and access programmes to ensure affordability of such drugs to the marginalised section of the society. Moreover, many companies have adopted differential pricing strategies and have lowered their international prices significantly to make the products affordable to the Indian market. It is important to note that for adequate access to medicines there are other critical barriers too. For example, when the national immunisation programme provides six vaccines free of cost for primary vaccination, still its coverage is only 60 per cent of the population. Further, NACO provides free ARV treatment to the poor, yet the drugs have not reached all those in need. Considering all these reasons OPPI believes that with the approaches, as mentioned above, the issue of pricing of patented products can be effectively addressed by the government and the industry together. However, we should keep in mind that patented products currently contribute less than even 1 per cent share of the total Indian pharmaceutical market by value. Hence, it does not appear to be posing a significant access issue in the country.

Founder Chairman, Esemcee Advisors The need for affordable drugs has become mission critical for governments of both developed and developing nations. Healthcare costs whether subsidised or not by the state are negatively impacting both the GDP of the country as well as the budget of an ordinary citizen. In a country such as India, cost of hospitalisation and medical treatments pushes people below the poverty line and forces them to sell assets. India is a country where scales can help reduce costs. In case of therapeutic substitutes price control may not really be relevant as the doctor will prescribe effective low cost substitutes. Quality generics will automatically neutralise the impact of brands with no added value. However, price control is necessary and the appropriate mechanism in case of non-substitutable essential life saving drugs and it provides low price points for the consumer and also safeguards the intellectual property interests of an innovator. Therefore, price control for such products is in order. In case of life saving monopolies such as anti-cancer and HIV drugs where saving lives is mission critical for the country and large volumes of populations are adversely affected by the disease, the decision to permit licensed manufacture so that they are available at an affordable price and accessible in volumes across the country is the only solution. Globally, the pipeline of new drugs is poor. It has nothing to do with price controls and profits, but limitation in innovation. It may be worthwhile for governments to help subsidise and fund research to keep the costs of new drugs affordable. With all the debates against price control pharma companies have been the most profitable next to IT companies. With inputs from Nikunj Sharma

Editorial take To make drugs affordable and accessible one needs to strike a balance between providing the impetus for innovation and meeting the needs of large patient population with affordable therapies. Certainly, price control is not the only mechanism.


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

Insight & Outlook: Interface

21

Pharmaceutical industry is very conservative in its approach and it takes time to allow the entry of any new product can meet the requirements of the Japanese British and European Pharmacopoeias. Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

How important is innovation for you? Innovation is an extremely vital aspect for Dow Chemicals Company. We believe that innovation is one of the most significant aspects of the pharma industry. Constant efforts are on so that the total cost for the consumers is reduced. This is the first angle. The second side of innovation is to enable the pharma companies to grow their top line. Looking at this we launch different products in the market. Further, innovation also helps in making the company more efficient from the manufacturing side. Thus, at Dow Wolff Cellulosics, we strive to bring innovative solutions that help enhance the health of people. By offering a technology with a compelling cost savings potential, we are one step closer to achieving our goal. Kindly elaborate on the smart solutions offered by your company. For more than half a century, we have provided leading pharmaceutical companies with innovative, reliable products and solutions that help in addressing the need of the patients. MethocelTM premium family of products offers exceptional flexibility and a broad range of water-soluble polymers with a valuable combination of properties that typically cannot be found in other water-soluble polymers. Next, with their non-iconic, waterinsoluble nature, the EthocelTM family of products is a natural choice when working with water sensitive Active Pharmaceutical Ingredients (APIs). EthocelTM can be paired with watersoluble excipients, including MethocelTM cellulose ethers. EthocelTM can be just the right ingredient to help develop a range of important medicines, including those requiring controlled release properties. We offer nine different EthocelTM projects providing a wide range of formulation flexibility. These include a variety of molecular weights, which translate into a range of viscosities in solutions to meet product or process requirements. Further, PolytoxTM is a family of non-ionic, high molecular weight, water-soluble poly (ethylene oxide) polymers. They provide a proven solution across multiple manufacturing processes, and have a long history of successful applications in pharma products, providing a range of excellent properties that can help deliver important pharma innovations. These are white, free flowing hydrophilic powders supplied in a wide variety of molecular weight grades, allowing manufacturers to select from many options to control dosage size, matrix release profiles and production methods while maintaining consistent flow properties and tablet performance. How regulatory compliant are your products? Our products comply with requirements of the USFDA, the Food Chemicals Codex, the International Codex Alimentarius and/or US Pharmacopoeia (USP) or National Formulary (NF). Premium cellulose ether products also

How do you contribute to the industry? The diverse, experienced team provides value beyond just ingredients. We serve as the trusted, valued collaborator in driving innovation and new technologies that will deliver medicines that the world needs. We try to resolve technical issues involving excipient behaviour, assist in selection of the right product to optimise formulation needs, support novel pharma applications, understand and address the emerging and future needs in the pharma market, aid in drug safety and efficacy through new formulations and manage and extend product portfolio. What are the primary challenges that you face while marketing these products? Pharmaceutical industry is very conservative in its approach and it takes time to allow the entry of any new product. So, if one considers that the time

‌says Dago Caceres, Global Strategic Marketing Leader, Dow Wolff Cellulosics. Here, he discusses several important market decisions and strategies required for growth.

from when we comprehend the demands of our customers to the time when we actually offer the solutions is very long.

However, with time, this is changing and we can see that we are developing new technology everyday.


Mod er n P har m a•1 - 15 J anuar y 2 013

22

Projects

Projects

Project news: Raptakos Brett & Co Ltd is planning to set up a new pharmaceuticals project at Thane in Maharashtra.

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Manufacturing of capsules Project type: New facility Project news: Zim Laboratories Ltd is planning to set up a new pharmaceuticals project at Nagpur in Maharashtra.

Manufacturing of drug Project type: New facility Project news: Actis Pharmaceuticals is implementing a bulk drugs manufacturing project in Andhra Pradesh.

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

Project location: Visakhapatnam, Andhra Pradesh Project cost: NA Implementation stage: Ongoing

Contact details: Zim Laboratories Ltd B # 21 – 22, MIDC Industrial Area, Kalmeshwar Dist.: Nagpur – 441501, Maharashtra Tel : +91-7118-271990-271370 Fax : +91-7118-271470 Email: bdd01@zimlab.in Website: http://www.zimlab.in

Contact details: Actis Pharmaceuticals Pvt Ltd Parawada Mandal, Visakhapatnam - 531 019 Andhra Pradesh Tel : 040 4019 0034 Email: info@actispharma.com Manufacturing of igol fizz Project type: New facility

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

Contact details: Kemwell Biopharma Pvt Ltd Kemwell House, 11, Tumkur Road, Bengaluru, 560 022 Tel : (+91-80) 3928-6200 Fax : (+91-80) 2337-9152 Email: Info.India@Kemwellpharma.com Manufacturing of moxifloxacin, telmisartan, olmisartan medomoxil Project type: New facility Project news: Ind Swift Labs Ltd is planning to set up a new pharmaceuticals project at Jammu in Jammu and Kashmir.

Contact details: Raptakos Brett & Co Ltd 21 A,Mittal Tower, A Wing 210, Nariman Point, Mumbai - 400 021 Tel : 022 4085 6000 Fax : 022 4085 6020 Email: contact@raptakos.com Website: www.raptakos.com/ Manufacturing of monoclonal antibodies Project type: New facility Project news: Kemwell Biopharma Pvt Ltd is planning to set up a new pharmaceuticals project at Bengaluru (rural) in Karnataka. Project location: Bengaluru, Karnataka Project cost: NA Implementation stage: Planning

Project location: Jammu and Kashmir Project cost: NA Implementation stage: Planning Contact details: Ind Swift Labs Ltd SCO 850, Shivalik Enclave N.A.C. Manimajra, Chandigarh - 160101 Tel : +91-172-2730503, 2730920 Fax : + 91-172-2730504 Email: info@indswiftlabs.com Website: www.indswiftlabs.com/

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India • Tel: 022 28666134 • Fax: 022 28013817 • Email: parmeet.d@tendersinfo.com

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Mo d er n P har ma•1 - 15 J anuar y 2 013

Event List

N AT I O N A L E V E N T S IJCPPT-IOAJ

Pharma World Expo

The International Joint Conference on Pharmacology and Pharmaceutical Technology aims to recognises talents among the research scholars, by awarding them Trophies and Certificates of merits. In each track of the conference, there will be one best paper presentation award is being given to the scholars, based on the various criteria such as content of paper, originality of paper, PPT preparation, presentation style, and handling question & answer, January 6, 2013, India International Centre, New Delhi

Pharma Bio World Expo is one of the foremost shows for pharma and biotech industry in India. The show aims to be one of the largest exhibition and conference for chemical and pharma industry. There will be visitors and exhibitors from pharma processing, plants & equipments, pharma packaging machinery & materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, laboratory reagents / chemicals), environment control equipment & services, etc). This event aims to be a perfect meet for the entire industry; January 15-18, 2013, Bombay Exhibition Centre, Mumbai

For details contact: IJCPPT Tel: 09040051114 Email: ijcppt.india@gmail.com Website: www.interscience.in

Innovasia 2013 An excellent platform to build business, Innovasia 2013 falls under the umbrella of Vibrant Gujarat. The event aspires to highlight current technologies to combat current and future hurdles in fields of agriculture, production industries, infrastructure, energy, healthcare, IT, media and applied sciences; January 8-13, 2013; at Mahatma Mandir, Gandhinagar For details contact: Sunil Shah Global Innovation Center All Gujarat Innovation Society Ahmedabad Tel.: 9978904476 Email: support@gisindia.org.in Website: www.gisindia.org.in

For details contact: Chemtech Foundation Tel: +91 22 22874758 Fax: +91 22 22870502 Email: conferences@jasubhai.com Website: www.chemtech-online.com

Med Techno In this expo all kinds of healthcare products and services and different kinds of useful medical equipment and instruments will be given supreme importance. This expo will draw the attention of the leading experts related to medical and pharma industry. All kinds of healthcare techniques will also be highlighted in this expo. This aims to bring some useful and developmental changes in the medical industry and medical equipment & instruments manufacturing companies. These changes will be of great help for

INDORE Madhya Pradesh, Jan 11-14, 2013

AURANGABAD

RUDRAPUR

HYDERABAD

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

Andhra Pradesh, May 31- June 3, 2013

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

For details

Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@network18publishing.com

this industry to fulfill the requirements of their clients and patients. January 4-6 (Pune) and January 25-27, 2013 (Vijayawada); at Auto Cluster Exhibition Centre (Pune) and A Convention Center, Vijayawada, respectively For details contact: eyeball Media Pvt Ltd Tel: +91-44-45671150 Fax: +91-44-45671191 Email: santhosh@eyeballmedia.in Website: www.eyeballmedia.in

BioAsia 2013 This year, BioAsia is geared to carry forward the momentum with its tenth edition - BioAsia 2013. One can expect the best convergence at this much-awaited and most comprehensive lifesciences dynamic global forum. This time, through the succinct, cutting-edge theme of technologies, business, etc, BioAsia 2013 will explore a bio-future waiting to be shaped by the next big industry trends primarily biologics & biosimilars; January 28-30, 2013, HICC, Hyderabad For details contact: Federation of Biotech Association (FABA)

Tel: +91 (40) 66446577 Email: paridhi@bioasia.in Website: www.2013.bioasia.in

PHARMAbiotika PharmaBiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference which is going hand in hand with the exhibition. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analyzing the exhibiting plan and help execute trade objectives, June 20-22, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar, Gujarat For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 – 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com

I N T E R N AT I O N A L E V E N T S BIOSIGNALS 2013 The purpose of the international conference on Bio-inspired Systems and Signal Processing is to bring together researchers and practitioners from multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems. A diversity of signal types can be found in this area, including image, audio and other biological sources of information. The analysis and use of these signals is a multidisciplinary area including signal processing, pattern recognition and computational intelligence techniques, among others. With this vision in place the event aims to reach out to the industry professionals; February 11-14, 2013, Barcelo Sants Hotel, Barcelona, Spain For details contact: Biosignals Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: biosignals.secretariat@insticc.org Website: www.biosignals.biostec.org

Bioinformatics 2013 The purpose of the international conference on bioinformatics models, methods and algorithms is to bring together researchers and practitioners interested in the application of computational systems and information technologies to the

field of molecular biology, including for example the use of statistics and algorithms to understanding biological processes and systems, with a focus on new developments in genome bioinformatics and computational biology; February 13, 2013, Barcelona, Spain For details contact: Bioinformatics Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: bioinformatics.secretariat@ insticc.org Website :www.bioinformatics.biostec.org

EAHP ‘Improving patient outcomes: a shared responsibility’ is the theme of the 18th Congress of European Association of Hospital Pharmacists (EAHP). This topic covers two of the major goals of the association: the commitment to the patient and the importance of collaboration with other health professionals. Hospital pharmacists are the stakeholders in optimising the medication of inpatients, but their responsibility does not end at the interface to primary care. Due to the fact that this is prone to errors, the Congress will focus on the different aspects of the interface with the scope of helping all participants to understand the origin of faults, March 13-15, 2013, Paris, France For details contact: EAHP Tel: +32-2-741-6827

Fax: +32-2-734-7910 Email: taviana.caminiti@eahp.eu Website: www.eahp.eu

International Conference on Life Science & Biological Engineering The aim objective of LS&BE 2013 is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in networking and digital society. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; March 15-17, 2013, Tokyo, Japan For details contact: Kwansei Gakuin University Tel: +81 798 54 7394 Fax: +81 798 54 6082 Email: craig.mark@kwansei.ac.jp Website : www.lsbe.org

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

lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422 Fax: +82-2-566-6084 Email: ict@ict2013seoul.org Website: www.ict2013seoul.org

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11,2013, Korea For details contact: Terrapinn Pte Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email:enquiry.sg@terrapinn.com Website: www.terrapinn.com The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.


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Mo d er n P har ma•1 - 15 J anuar y 2 013

Event Report

64th Indian Pharmaceutical Congress (IPC)

Broadening horizons for small- and mid-sized pharma manufacturers Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

T

he Indian Pharmaceutical Congress (IPC) was held at SRM University, Chennai, between December 7-9, 2012 at SRM Nagar in Kattankulathur. It was hosted by the Association of Pharmaceutical Teachers of India (APTI) where the theme was ‘Vision 2020: Pharmacy Education: Innovation, Strategies and Globalization.’ Senior government officials including secretaries, Directorate General of Foreign Trade (DGFT), Drugs Controller General of India (DCGI) were invited for the event.

Highlights of the IPC The exhibition was a golden opportunity for small- and medium-sized pharma companies involved in exports. International Business Meetings were organised in the side lines of 64th IPC at Chennai. Importers, buyers, FDA and drug regulatory officials from Africa, America, ASEAN, CIS, EU regions were present at the event. Thus, pharmaceutical manufacturers were able to interact with foreign delegates looking for pharma products from India. The scientific session was inaugurated by the Chief Guest - Dr G N Singh,

The IPC hosted in Chennai this year was a great opportunity for small- and mediumsized pharma manufacturers to explore their horizons. The seminars conducted were highly educational and were aimed at the upliftment of the pharmacy profession in totality. Read on to find out more... Drug Controller General of India; Ravi Pachamootu, Chairman, SRM University; Prof K Chinnaswamy, President, Indian Pharmaceutical Congress Association (IPCA); Dr B Suresh President, Pharmacy Council of India and N R Munjal, Chairman, Pharmexcil. There were technical sessions where FDA/drug regulatory officials of various countries made presentations on drug regulatory systems in their respective countries. The three-day programme was divided into three sessions for business meetings including one followup session. Speaking about the Congress, Atul Nasa, Organising Secretary, IPC and President of Indian Pharmacy Graduates Association (IPGA) and Managing Trustee, IPGA Welfare Trust, said, “The conference was good in all aspects. The exhibition was good and the campus and infrastructure was excellent. A resolution was passed during the open session on the last day for the upliftment of the pharmacy profession.”

SDPS announcement Of late, there has been great emphasis

Inaugration of SDPS by dignitaries at IPC

on developing, formulating, and manufacturing high quality, effective and safe drugs. The pharma industry needs to concentrate on these three factors. Keeping this in mind, an initiative had been taken to form the Society for Pharmaceutical Dissolution Science (SDPS) by a team of experienced senior professionals from the Indian pharma industry and academia. The official announcement of the SPDS was made at the 64 th IPC.

IPC 2013

Nasa added, “The 65th IPC will be held in New Delhi by the IPGA. We are in the process of finalising the new local organising committee in Delhi who will conduct the conference. This year we are expecting more than 10,000 delegates at the Congress. We are also in the process of finalising the venue. The 65 th IPC will be held in December 2013. The President of the next IPC is Dr G N Singh, DCGI.”


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

Book Review Phytopharmaceutical Technology

Editors: P H List & P C Schmidt

This is an English version of the original German publication by the editors on processing of plant products into dosage forms. This seven chapter reference book is a concise glimpse into all the processes and technology involved in the plant-based drug industry. Chapter 1 deals with the different types of medicinal forms available from plant sources & the drug extracts from plants. Chapter 2 deals with raw materials and ensuring quality control of these imported products with respect to the final formulation. Of particular significance is the subtopic on pesticide regulations. Chapter 3 deals with various organic and inorganic solvents used in extraction of active principles from the plant raw materials. Chapters 4 and 5 are the largest chapter dealing with processes, processing methods, technology and instruments. Subtopics meant for extraction, purification, drying and distillation. The book concludes with an important chapter dedicated to quality control and processing into dosage forms. A good concise reference book for students, pharmacists and stakeholders interested in natural plant based drug formulations.

Price: ` 895

Editors: S S Agrawal & M Paridhavi

Herbal Drug Technology

Price: ` 775

This second edition textbook from two renowned authorities on pharmacology is a standard text for students in most of the universities. Simple language, easy to understand concepts and basic principles being explained are the hallmarks of this text. The initial three chapters details the different traditional systems of medicine and advent of herbal therapeutics over past decades. The fourth chapter is an impressive collective of coloured plates of plant sources and their basic properties. The chapters on botany and tissue culture give a modern take on ancient traditional plant sources. The next few chapters on standardisation, extraction, screening and examination of powdered forms give a basic understanding of concepts and technology in this field. Of particular note are the addition of chapters on nutraceuticals, chemotaxonomy, patents and herbal cosmetology. Each topic is explained in precise points of sentences, which makes it an efficient preparatory book for examinations. This is an excellent book as a study text for all students of pharmacy and associated sciences.

Publisher: Informa Healthcare Distributor:Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

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

27

Publisher: Pharmaceutical Press Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com


28

Mo d er n P har ma•1 - 15 J anuar y 2 013

Products

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

Automatic labelling machine Automatic labelling machine is suitable for the application of the vignette label onto the main panel and of two self-adhesive tamper evident seals on the closure point of formed cartons. The machine is designed for carton Track & Trace by means of 2D datamatrix codes printing on line and subsequent verification with camera vision systems. It is an ergonomic balcony-design machine that offers full access to ensure cleaning and management comfort and guarantees a full view of the entire production process. The labelling machine works by steps, consequently guaranteeing high precision in label application and the finished result. Size change over is precise, easy and quick. Marchesini Group India Pvt Ltd Mumbai - Maharashtra Tel: 022 - 67082755/64 Fax: 022 - 67082761 Email: info@marchesini.com, philippe@marchesini.in Website: www.marchesini.com

Three phase thyristor power controller It features 15KW and 30KW models, operates on 3 phase supply with auto/manual operation. It is suitable for 3 or 4 wire star configuration / 3 or 6 wire delta configuration. It accepts (4-20)mA / (0-5)VDC / (0-10) VDC control input and has an adjustable voltage limit per phase. The design is simple and modular for easy servicing of cards and thyristors. Thyristor power pack has a varied application and can be used with heating elements like Nichrome, Tungsten, kanthal, super kanthal, silicon carbide, molybdenum, infrared, etc. where precise and accurate power control is required. There is significant power savings with respect to conventional contactor type temperature control system. Libratherm Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 28963823, 28960569 Fax: 022 – 28964769 Email: sales@libratherm.com, libratherm@libratherm.com Website: www.libratherm.com

GPS synchronised clock GPS synchronised clock solution provides a unique and error-free timing solution for the entire facility. It features GPS satellite synchronised timing with no need of manual setting / adjustment. It is built with a wide range of LED display size from 20mm to 200mm

and colours ranging from red, green and white to work in any environment. It is a complete wireless solution which helps in eliminating expensive cabling costs and significantly reducing the installation time. It is also equipped with SS-304 stainless steel housing and flame-proof enclosures available for hazardous areas. There are various choice of mounting options such as table-top, wall-mount or hanging type along with 32 timezones and automatic day-light savings adjustment facility. Essae Teraoka Limited Bengaluru – Karnataka Website: www.essae.com

Aerosol photometer The latest version, Model 2i, is used for leak testing of HEPA filters. The upstream aerosol mass concentrations are displayed in actual mass concentration values of micrograms per litre (µg/l). Other features include user settable Aerosol Noise Suppression (ANS) which allows for more stable aerosol measurements when poor mixing is present, three unique data report functions – continuous, monitoring and summary modes, large 4.3” LCD display, thermal printer option to meet documentation requirements and USB output.

High purity water solution

must To make the product of superior quality, it This adhere to safety and contamination-free norms. , makes the end product well accepted in the market thus reducing its rejection rates.

High purity water generation and distribution system is fully prevalidated to industry accepted standard, packaged on single skid, hot water sanitisation, fully functional FAT (factory acceptance test), compliance with latest USP, Ph Eur, CGMP/ CGAMP and ISPE specifications and design standards, fully automated with SCADA. It is complete, integrated, specially designed solutions which includes - demineralised water, purified water, pyrogen-free water and water for injection that are critical to the pharma industry’s processes. They deliver customised, specialty systems that meet stringent requirements for high purity water generation and distribution. Ion Exchange (India) Ltd Mumbai – Maharashtra Tel: 022-39890909/30472042 Fax: 022-24938737 Email: ieil@ionexchange.co.in Website: www.ionindia.com

High speed centrifuge

Preventol is a ready formulated disinfectant concentrate with cleaning power, highly effective in combating and eliminating a broad spectrum of microbial activity arising from bacteria, viruses, fungi and spores. This formulation combines the benefits of new generation phenolic active ingredients and stabilised aldehyde-based active ingredient to create a synergistic combination. It is proven to be effective where there is a high combination of blood and/or protein and against naked viruses. It is perfectly suited for surface disinfection in hospitals, clinics, nursing homes, commercial establishments, manufacturing areas and animal houses. It is also ideal for protecting medical devices and instruments.

High speed centrifuge features a 100,000 xg top speed performance and supports high-throughput s a m p l e processing from 50 mL conical tubes and microplates to 1 L bottles, up to six-litre capacity, meeting the evolving needs of academic research and production facilities alike. Run setup is easy with the intuitive touchscreen interface featuring a bright, highly visible and durable display, while on-board video tutorials and access controls, such as user login with password protection provide advanced training and programming options. High speed centrifuge series features built-in safety and rotor technology innovations that shorten run set-up time and increase security using secure, push-button auto-lock rotor exchange in less than 3 seconds which ensures that the rotor is automatically and securely locked and will not loosen during a run. It is lightweight and has corrosion-resistant carbon fiber rotors including the new Fiberlite LEX designs and improved ergonomics.

Lanxess India Pvt Ltd Thane - Maharashtra Tel: 022- 25871000/25871540 Fax: 022-25826742 Email: sunder.rajan@lanxess.com Website: www.lanxess.com

Thermo Fisher Scientific India Pvt Ltd Mumbai – India Tel: 022- 67162200, 67162259 Fax: 022- 67162244, 1800 22 8374 Email: qfc.customercare@thermofisher.com Website: www.thermofisher.com, www.thermo.com

MeasureTest Instruments Mumbai - Maharashtra Tel: 022-2202 7982 Email: sheesh@mtnl.net.in Website: www.measuretest.com

Disinfectant

Agnish Roy Manager Business Development Marsap Services Pvt Ltd

Fluid bed dryer Fluid bed dryer is used for drying of wet material. It is equipped with air handling unit. The inlet air filtration is through pre, micro vee and hepa filter. It performs uniform and harmonious drying operation in a specified time. It has applications in tablet-granulation section of pharma industries. This dryer is compliant with CGMP under WHO and USFDA. Also offered is diversified novel advanced techno-upgraded qualitative model of fluid bed dryer like PLC operated, semi-automated and manually operated dryer with multi faceted and user-friendly features. Ratnakar Pharma Machinery Ahmedabad - Gujarat Tel: 079-22892614, Mob: 09427031284 Email: ratnapd@yahoo.co.in Website: www.ratnakarpharmamachinery.com

Hot water system Hot water systems provide highly efficient solution to instantaneous hot water generation using energy efficient heat exchangers such as funke brazed, gasketed plate heat exchanger or Ecoflux corrugated tube heat exchanger. The hot water systems can also be installed with storage vessel for semi-instantaneous applications and in conjunction with solar based hot water systems. A Hot water system not only heats the water to a desired temperature using low pressure steam but also maintains the required temperature of water with better temperature control using automation and control. Application areas include pharma – single fluid heating and cooling systems, food, HVAC, hospitals, hotel, textile and breweries. HRS Process Systems Ltd Pune - Maharashatra Tel: 020-2566 3581 /82, Mob: 09096699998 Fax: 020- 2566 3583 Email: info@hrsasia.co.in, Website: www.hrsasia.co.in The information published in this section is as per the details furnished by the respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma


Mo de rn Ph a rm a •1 -15 Ja n u a r y 2 013

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harma.in

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In Convers

ation With

Dr Swati Piramal Vice Chairp erson, Piramal Enterprises Ltd

FDI throu gh FIPB investments may hamp er in

14

Strides, Lilly in

Special

Focus 15

Higher pharmacy studies Is the grass greener on the ‘Western’ side?

Interface 17

Dr R S Gaud Dean, (SPPS PTM)

E - mail : ............................................................. Subscriber’s Signature :.............................................................. Policies & Regulatio ns

Indian pharm Patent laws , Reacting SVKM’s 19 Why MNCs NMIMS to in pharm on all foreigthe governmen a, FABA a are shying t’s away from domestic n investments decision patenting Indian Eli Lilly policies? pharma in existin by the FIPB on firms to be cleare g Arcolab and Company Shakthi a comp ulsory basis,d expand Ltd have collaband Strides delivery included Secretary, M Nagappan, orated in emerg of Executive as part AssociationFederation of Asian ing mark cancer medic to Lilly has of the this arran ines agreement ets. As Biotech high-qualitthe right to of BioAs s (FABA), the , add will in-lic geme nt, Lilly a part of ia 2013, organ Arun Kuma products y branded gener additional route all said, “Deci isers r, Foun of high- ense a portfo CEO, Stride to the portfo the FDIs ic oncol sion der lio through qualit to ogy deligh & s Arcol lio in the y, brand gener ic the FIBP in pharma sector ab said, Group “Cancer ted to future. reduce ed injec tible “We medicines partn oral the invest may decelerate expand highest cance r and and of the unless its brand er with Lilly are ments qualit from appro medi cines with into India, ed be an unme y continue to Agila mechanism priate & to that high-quality generics platfo t need Speci the specia transp rm oncology markets deployed s and system arent lties divisi alties , around in many globa will benefit products Strides from Building the world s are on of l presen Arcolab such applicto scrutinise ce in key Lilly’s stron in Benga Ltd, based ations witho and process investmen on our recen . Commenting g markets.” luru. ut delays Agila branded t in a Lilly-t Van Der Spuy, on the occas .” Ind-Swift generics ion, Melt Managing manu factuSpecialties Lilly and in China platform will ` 1,500 targets to achie medicines, re strategic Company India, Director, Eli crore reven ve this agree earlier this year, canc Ind-Swift partnership said, “This and Lilly er ue by 2015 register entry into Lilly expanment will help mark will Kumar is hopin Laboratories, and mark s Lilly India’ a medications g our commbranded gener et and delive d its portfo s ics, reaffir revenue to achieve ` drug firm itmen lio patien in multi these across 1,500-crore cancer medicr high-qualit ple geogr ts. We t to reach more ming the emer markets by 2015 with y believ aphie ines Indian additi such as will ging across s said on to Japan, the overseas Union emerging to patients and help us build e this partnership the initia markets. In Jacqu and European markets,” more mean a significant l 10 medic President es Tapiero, the main the United States being larger ingful presen Indian Senior ines growth Markets and President cancer Vice drivers. At presen ce in the segm Division, enable – Emer t, Ind-S us to better ent, and is witne ging Lilly. hence, Indian ssing 15 wift Laboratorie serve patients growth. s suffering many more Company’s to 20 per forms of cent stand at from variou cancer.” over ` 1,000 current reven s ues the comp any will crore. Primarily, on its core continue Piramal business, to focus Enterprises’ ie, API Resources business. subsidiary Dr Redd Group Decisi y’s launc Internationa has acquir on leadin LA in India hes Pamo ed Abacu g mobil based globall, a pioneer relinÒ e comm Dr Reddy in eviden s “We market ’s for many ce- growt are excite unication tools.” access announced Laboratories d to contin solutions h as Ltd recen leadi ng of the world’s ue our PamorelinÒ that it has tly company,” a Decision Resou comp anies healt hcare launched rces Group said Simon LA in 3, 2012, . Howa under an India on Decem acquisition As part The rd, CEO, Abacus ber and sales exclusive of of UK-b agreem Abacus in India its ongoing ased “We view International. ent with marketing GroupTM, by investment , AB Debiopharm The acqu Massachuse Burlington, leade r SCIEX, as a majorthis acquisition LA is used Switzerland. isition is in life a globa PamorelinÒ part of Decision tts-based step towar science l becom advanced for the treatm DRG’s analy Resou ent Group overall integr ing a fullyd strategy technologie tical dependent or metastatic, of locally will result rces ated global to acqu s, a signif hormonehas prosta ire and/ access solutio in or build marke started icant PamorelinÒ te cancer. bran expansion ns provid t global a new $ LA will in bulk 3 millio leverage ds that can Our team of experi er. be impor Resou rces of Decision n facility each othe health Pharmaceutifrom Debio ted in Delhi thought r’s marke economic enced Recherche market access Grou p’s to give made availa que (Debio RP). leadership and scient t access capab Abacus and labor ists It will be specialists look and oncol ble primarily will be part ilities. atory forwa to Market ogists across urologists technicians of the rd incorporatin Acces to India. Unit at Decisi s Business acros s and payer g the market Anacor on Resou India Blair research currently access rces held announce data Group, which to Pharmaceut includes by sister Formulary, the brand analytical the latest innov comp at Decis icals phase II s positive resul Group to techn ations ion Resouanies trial PharmaStrat HealthLeade s: Fingertip improve ts from in This state- ologies. Anacor rs-Int value comm rces our of-the-art, support “Abacus and Pinsonault. erStudy, unications payer insight and announcedPharmaceuticals centre The acquis deliverables combinatio brings to the is design scientific address recently positive ition is phase .” table Resources ed to help some result part II and robus n of technical a unique of analytical (PK), and safety, Pharm s from a to acqui Group’s overaof Decision t, eviden excellence challenges, India’s bigge acokinetics analysis efficacy safety, ce-based based phosp brands re and/or buildll strategy resulting trial environme including foodst that can in solutio that are vitamin hodiesteras of its boronntal prote leading inhibitor, leverage well-designe ns e-4 ction AN2728, address each research, D analysis, thought d to 12 - 17) in adoles (PDE-4) the needs biomedica , leadership other’s testing with healthcare abuse and meaningfu of banne l to dermatitis, mild-to-mod cents (ages d clients,” of our l produ create erate atopic Lang, therapeuticsthe developmen drugs of services cts by inflam a chronic rash President said Jim and for the t of new and gener characterised mation Access - Mark industry. healthcare “AB SCIEX “Data from and ic drugs et . Decision Business Unit, continues significant impo rtant “Abacus is our first itching. in adole an scents with study of AN27 “Besides Resources Group acqui sition strategic investments in to make in Decis are prom 28 . area of India as ising, withatopic dermatitis global markeexpanding Rainer Group’s ion Resources focus for a patients our Blair, Presid us,” said achieving 35 per cent and produ t access servic “We are to expan overall strate ent, AB of ‘clear of es gy an ISGA d our SCIEX ’ also allowscts, the acquisition to and committed to access minimum or ‘almost clear’ score meeting responding. capabilitiesmarket us to now market of India offer our the offer Howard said David 2-grade impro with a access and ’s resear growing needs device and capabilities vement,” analytical innov ativeclients the most Perry, CEO, ch and for applied Anacor. to signifi diagnostic indust the medical highwork relenttesting comm advisory , Peter Hoen cantly expan ry as well solutions,” value lessly every unities. We support truste as igsber d our d Resources said partner day capabilities, g, CEO, comm with Indian to be a Group and lab Decision with indusercial will scientists rema in . Abacus Intern trycustomer-c managers. Bicester, headq uarte ational Our entric new England. will allow facility red in in our custo us to take the Gurgaon science mers to reshape lead with in thinking this amazingly analytical region of the worldforward.”

pact to exp and delive ry

Piramal’ s su acquiresbsidiary DRG Abacus

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Modern Pharma - 1-15 January 2013