16-31 Augus t 2012 I Vol 1 I No 4 I `100
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In Conversation With 13
Special Focus 14
Insight & Outlook 22
Apurva Shah Group MD and Co-Founder, Veeda Clinical Research Pvt Ltd
South East Asian countries Next hub for outsourcing?
Does India follow a stringent regulatory process for approving clinical trials?
Energy Management Green logistics: Cost effective A myth or reality?
Ranbaxy reports ` 586 crore loss in Q2 2012 RANBAXY Ranbaxy Laboratories posted an unexpected quarterly loss of ` 586 crore ($106 million) as foreign exchange losses ballooned although sales in its key US market more than doubled. Net sales rose 54.5 per cent to ` 3,174 crore. The depreciation of the rupee against the dollar, though favourable to Ranbaxy’s export business, had an adverse impact on the company, said Ranbaxy. “Sales and profitability grew in the quarter with overall improvement across major regions, aided further by exclusivity sales in some of the key markets,” Arun Sawhney, CEO, Ranbaxy said in a statement.
Diabetes and BP tablets at ` 2 each Ozone Pharmaceutical is planning to sell medicines for chronic diseases like diabetes and blood pressure under a uniform pricing initiative where they will cost as low as ` 2 per tablet. “We have decided to take this uniform pricing initiative to make these medicines affordable despite the fact that this will impact our margins substantially,” said S C Sehgal, CMD, Ozone Group.
Wockhardt ushers into top 3 Indian pharma companies Wockhardt Ltd delivered 95 per cent increase in Profit After Tax (PAT) at ` 378 crore in the first quarter of financial year 2012‐13. The EBITDA at ` 502 crore grew by 61 per cent and represented 10th consecutive quarter of sequential growth.This sustained EBITDA and PAT performance, both in terms of value and margins, now ushers Wockhardt amongst the top 3 best performing Indian pharma companies.
Piramal’s Imaging Division and IBA Molecular in pact Piramal Imaging SA (Piramal) and IBA Molecular announced an agreement whereby IBA Molecular will manufacture and distribute 18F-Florbetaben, Piramal’s diagnostic imaging agent, in the European and US markets. 18F-Florbetaben is a radiopharmaceutical currently in development for use with Positron Emission Tomography (PET) for the detection of beta-Amyloid plaque deposition in the brain, a pathological feature associated with Alzheimer’s and other neurologic conditions. “18F-Florbetaben is our lead compound in the molecular imaging business, and we are confident that it has the potential to increase clinicians’ accuracy and confidence,” said Ajay Piramal, Chairman, Piramal Group.
Pharma companies commit to improve drug access in India ORGANISATION of Pharmaceutical Producers of India’s (OPPI) Conclave on ‘Access, Innovation and Reach of Healthcare in India’ chalked the thought of improving healthcare access throughout India through innovation and research by drug companies. Among those present were Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals, Government of India; Dr Nata Menabde, WHO India Representative; and Dr K Srinath Reddy, President, Public Health Foundation of India (PHFI). Kalha commented, “You could argue that government has not done the best but you cannot say that the government has not paid attention at all. Over the decade things have improved and there have been failures and successes.” He also highlighted that the agenda of all is to make the dream of affordable healthcare a reality and everyone has to
L-R: Ranjit Shahani, President, OPPI; Dr Reddy and Kalha
make their contribution to bring about a change. Tapan Ray, Director General, OPPI, said, “Access to healthcare comprises not just of medicines, but more importantly a robust healthcare infrastructure. In India, the demand for these services has outstripped supply.” Dr Menabde said, “If the government provides effective financing to deliver services to people in a responsive way, ensure fair regulation
and provide the necessary manpower, the performance will dramatically improve regarding easier access to facilities, better quality of services and higher system efficiency. This will ultimately contribute towards improved population health.” Dr Reddy elaborated on the need of universal healthcare, “The journey towards a better healthcare system in India has begun with the Prime Minister announcing 12th Five Year Plan as the ‘Plan for Health.’ The proposed increase in public expenditures on health from the current level of 1.2 per cent of GDP to at least 2.5 per cent by the end of the 12th Plan, and to at least 3 per cent of GDP in the 13th Plan is a step closer towards realising the universal healthcare coverage 2022 vision that seeks to entitle universal health entitlement to every citizen, guarantee access to an essential health package and integrate healthcare delivery.”
Stempeutics to launch India’s first stem cell-based product by 2013 STEMPEUTICS Research Pvt Ltd, a company developing stem cell-based medicinal products with facilities in Bengaluru, Manipal and Kuala Lampur, is in the process of bringing its first stem cell therapy product in the Indian market. Stempeutics is working on two products; Stempeucell, a stem cell-based product, is slated to be commercialised by 2014-2015. It is currently in Phase III trials. Another product Stempeutron, a fully
automated stem cell isolation device that will prove a boon for cosmetic surgeons is expected to be launched by 2014. B N Manohar, CEO, Stempeutics Research Pvt
Ltd, said, “We will be initially launching it in the Indian and Malaysian market and later we plan to expand to South East Asia followed by Europe and US.” Stempeutics will be coming up with its first OTC product - Stempeucare by 2013. It is derived from the conditioned medium in which stem cells have been cultured. Manohar said, “We are using the conditioned medium that is rich in growth factors and cytokines for its potential use
in the cosmetic segment.” Although we have not yet finalised the nature of the final product, we will be focusing on two indications namely anti-ageing and hair growth. In addition Stempeutics is still working on the cost factor and trying to make its stem cell-based products more economical as compared to the existing treatments. Manohar added, “We are making efforts to get the products covered under medical insurance.” - Shibani Shah
ClinTec International starts operations in Malawi CLINTEC International has expanded its operations into Malawi. ClinTech has partnered with oa pharma company for vaccine development in Africa and Asia. Africa is a pivotal region for the development of adult and paediatric vaccines against infectious diseases. The company is in the process of wrecruiting skilled personnel with
vaccine research experience to join its already established teams in Africa and Asia. Dr Rabinder Buttar, President, CEO and Founder, ClinTec International Group, stated, “Despite the challenging economic conditions through which many of our clients are restructuring their organisations, ClinTec continues to grow and win
major new business from pharma companies. The company is continuing to expand into interesting new regions for clinical research. As the pharma industry increasingly focusses its drug development efforts on the emerging markets, ClinTec will closely partner with its clients, aligning its services and operations to fit with their needs”.
M o d ern Pharma• 16- 31 Augu s t 2012
CONTENTS In Conversation With
Apurva Shah Group MD and Co-Founder, Veeda Clinical Research Pvt Ltd
Special Focus CROs South East Asian countries Next hub for outsourcing? Opportunities and challenges for Indian CROs End of a dream run...
Interface Denzil Benjamin Senior Director - Clinical Trial Management, Asia Pacific, ICON Plc
Roundtable Does India follow a stringent regulatory process for approving clinical trials?
Piramal Pharma Solutions, Ahmedabad Keeping pace with changing trends FOUNDER & EDITOR, NETWORK 18 Raghav Bahl
Insight & Outlook Policies & Regulations
PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan
Clinical Trials Registry - India: Make or mar?
SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Shibani Shah, Hemantraj Ratnakumar, Jasleen Kaur Batra (Bengaluru)
K V Subramaniam, President & CEO, Reliance Life Sciences
ASSISTANT ART DIRECTOR Varuna Naik
Rajkiran Kanagala Head, Business Development, TCI
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
Tips & Tricks
Energy Management Green logistics: Cost effective - A myth or reality?
DESIGN Sachin Bhogate
CRO partner Ways to choose the right one Nidhi Saxena, Founder, President & CEO, Karmic Lifesciences
EXECUTIVE VICE PRESIDENT Ananth R Iyer ASSISTANT GENERAL MANAGER - PPC Shekhar Khot
PRODUCTION TEAM Dnyaneshwar Goythale, Surekha Karmarkar, Ravikumar Potdar, Ravi Salian, Sanjay Shelar
OVERSEAS CONTACT Ringier Trade Media Ltd
REGULAR SECTIONS 5 6 25 25 26 27 28 29 30
Editorial / Guest Editorial News, Views & Analysis Tenders Projects Event List Book Review Products Marketplace List of Products & Advertisers
Highlights of Next Edition Special Focus: Biotech Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise
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Modern Pharma•16-31 Augus t 2012
Innovation on a transition n the ambitious journey to reach the milestone of $ 50 billion by 2020, the Indian pharmaceutical and healthcare sector faces numerous challenges on the way. One of the significant challenges is to enhance affordability of medication across millions. While on one hand, there is a dire need to adequately invest in R&D of innovative drugs and drug delivery systems for several emerging diseases, on the other, there has to be an effective mechanism by which such drugs (as well as the existing ones) are available & affordable. How necessary is it for patented drugs to be pricey? In this context, a recent World Bank working paper offers several insights. The paper focusses on the price behaviour of patented drugs in India post January 2005 when the domestic product patent regime for drugs began, based on impact analysis of the stronger Intellectual Property Rights (IPRs) on prices and supply of drugs. This study involves a single large therapeutic category - Central Nervous System (CNS) therapeutic segment, which in retail sales is the second largest globally, and one of the fastest growing in India. It delves deeper into the effects of introducing product patents for CNS therapeutic segment in the Indian pharmaceutical market and is based on proprietary data on pharma sales from 2003 to 2008 in order to correlate the figures when product patents were granted.
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
As one of the key findings of the paper, the introduction of product patent did not lead to any significant withdrawal of generic drugs having the relevant molecule. Further as per this study, product patents in overall appear to have a ‘positive and significant effect’ on the drug price. At the same time, ample therapeutic substitutes seem to be available for most new patented drugs. These findings point to numerous action measures on as many numbers of fronts. While one hopes that market prices of research-intensive patented drugs do not go through the roof, especially where generic substitutes are available, at the same time innovation in pharma should be duly rewarded. It calls for bringing in radical transformations to have avant-garde reward systems that will encourage low-cost manufactures and facilitate appropriate pricing of innovative drugs for better healthcare delivery. Last but not the least, the patent holder will be expected to raise the efficiency bar vis-à-vis the generic competitors, and thereby offer better price economy on a continuous basis.
Manas R Bastia email@example.com
Surviving myriad of challenges aving lived in the pharmaceutical sector for over many years in India and abroad, I have realised that there are infinite opportunities in the sector. While the overall trend is towards personalised medicine, there are many challenges that are preventing a faster growth in the sector. The challenges span across various dimensions of stakeholders including the regulators, investors, manufacturers, service providers and the consumers themselves. While the US has been trying to find solutions for the problems of tomorrow, the Indian healthcare ecosystem works reactively and often ends up addressing the solutions of the problems of yesterday that may or not be relevant today. The entire healthcare and life sciences ecosystem in India has not yet reached a maturity level to work in a highly efficient manner. The issues can be categorised under various buckets: (1) Paucity of risk capital for innovation: The risk capital available in India for innovation is restricted in silos with limited access to a collaborative pool of innovation. The best example of this is how the incubation centers of IITs are structured.
They are all doing good work in their own territories. But have limited access to the incubation centers of other IITs or IIMs. While in the US the research is now getting pooled in across various academic centres of research. (2) Lack of maturity of our regulatory framework: Our regulatory environment is still not mature enough to be able to look at the issues of healthcare and pharmaceutical sector in totality. Our regulatory system still addresses problems in piecemeal. Our regulators are still struggling to identify the real issues of the consumers in India. This is because our regulations are impacted more by what the businesses want out of them than what the consumers want out of them. The businesses may not always come out with the most ethical and long-term investment oriented approach. Their interest typically is on finding solutions leading to shorter term profits in their businesses. (3) Shortage of good quality and well trained manpower in the system: While India produces some of the best manpower in the world that can add value in the healthcare and life sciences ecosystem, India also loses its best resources to other countries.
Many of these resources have been coming back to India to contribute to the ecosystem. However, there is still a huge shortage and this shortage will continue over time. (4) Lack of high–end technology infrastructure: India’s technology infrastructure is mostly lagging and is not able to keep pace with the growth in the sector. This leads to an over dependence on other countries. (5) Less penetration of insurance: One of the biggest differences in India as compared to the developed countries is that the insurance in the healthcare industry is yet to penetrate to the masses. Given the insurance penetration levels at around 12 to 15 per cent in our country, the bargaining power will continue to be in the hands of the doctors. While I have identified the key challenges in the sector, there are various solutions offered by different stake holders to these issues. Many of these solutions are under test in the current state of the economy and results will only be seen as the time progresses. Vikram Gupta Founder and Managing Partner, IvyCap Ventures
Modern Pharma•16-31 Augus t 2012
News, Views & Analysis Novartis collaborates with University of Pennsylvania for research
Nichrome’s new R&D centre and office building inaugurated ESTABLISHED in 1948 in Pune, Nichrome ventured into the world of packaging in 1977 and since then has achieved a distinguished repute in the industry. With over 35 years of experience in design, development and manufacturing, and 5,000 installations across 40 countries, Nichrome has evolved as a premium brand for the packaging needs of the market. Nichrome has a state-ofthe-art, modern manufacturing infrastructure spread across 12 acre of land at ‘Shrimal’, near Shirwal, about 45 km south of Pune, with over 150 skilled work force for planning, engineering, automation, supply chain, machine assembly, product trials, testing, commissioning and service. Nichrome’s new R&D centre and the office building was
L-R: S V Joshi, Chairman; Kumar; and Harish Joshi, MD, Nichrome India Ltd
inaugurated by E K Kumar, GM, Asia Pacific, Tata Global Beverages Ltd. Covering a total area of 12,000 sq. ft, having capacity to house 150 persons, the new R&D centre houses the complete engineering and design facility with hi-tech 3D modeling software, parametric design and product data management facility. The new facility has a training centre
Ranbaxy enters into in-licensing agreement with Gilead Sciences RANBAXY Laboratories Ltd has entered into an in-licensing agreement with Gilead Sciences to promote access to high quality, low cost generic versions of Gilead’s HIV medicine emtricitabine (FTC) in developing countries including single tablet regimens containing emtricitabine, and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines. Under the new agreements, Gilead will provide a technology transfer for the manufacture of emtricitabine, together with funding to assist with investment in process improvements and reduce manufacturing costs. Commenting on the agreement, Arun Sawhney, CEO & MD, Ranbaxy, said, “Ranbaxy and Gilead have a strong collaboration going in the area of HIV-AIDS. We are pleased to extend this association with Gilead that will enable us to offer quality, affordable medicines for the treatment of HIV-AIDS in the developing countries.”
for conducting customer training programmes, a pouch and brand gallery. The new facility is also equipped with a product and pouch testing lab. While inaugurating the new office, Kumar said “The association of Tata Global Beverages Ltd goes back to 1985 when Tata Tea launched the first pouched tea in India using Nichrome machines.”
USFDA lifts import alert from DRLS’s chemical manufacturing facility, Mexico DR Reddy’s Laboratories Ltd announced that the import alert at Quimicas Falcon de Mexico SA de CV (Dr Reddy’s chemical manufacturing facility at Cuernavaca, Mexico), a wholly owned subsidiary of Dr Reddy’s Laboratories Ltd, has been lifted. Dr Reddy’s received a clearance from the US FDA on July 26, 2012. Dr Reddy’s
Parexel and KDD Fund collaborate to accelerate global drug development PAREXEL International Corporation has announced that they are the first Contract Research Organization (CRO) chosen by the Korea Drug Development Fund (KDDF) to help Korean companies develop and commercialise healthcare products for the global market. “Under the leadership of Dr Dongho Lee, the KDDF is expected to be an important resource for emerging biopharmaceutical
companies to advance their promising new technologies,” said Ron Kraus, Corporate VP and Worldwide Head, Parexel Consulting and Medical Communications Services. He added, “This partnership further demonstrates Paraxel’s commitment to the Asia-Pacific region and helps increase our opportunities for industry innovation.” Dr Dong Ho Lee, CEO, KDDF, said, “The Korea Drug
NOVARTIS and the University of Pennsylvania (Penn) announced global collaboration to research, develop and commercialise targeted Chimeric Antigen Receptor (CAR) immunotherapies for the treatment of cancers. In addition, the parties will jointly establish a new research and development facility on the Penn campus, called the Center for Advanced Cellular Therapies (CACT). “By combining Penn’s expertise on this pioneering technology with Novartis’ strength in bringing innovative therapies to patients, we have the potential to transform the future of cancer treatment,” said Hervé Hoppenot, President, Novartis Oncology. “This collaboration underscores our commitment to working with partners that are at the forefront of science and medicine. Immunotherapy is one of the exciting frontiers in cancer research and the CAR technology developed by the team at Penn has shown early promise as a new way for treating cancer” said Mark Fishman, President, Novartis Institutes for BioMedical Research.
Mexico facility was inspected by US FDA in November 2010. Based on observations by the US FDA, a warning letter was shared on June 14, 2011 with the company. Dr Reddy’s worked with US FDA to resolve the observations
Mylan launches commercial operations in India
Development Fund is pleased to work with Paraxel to establish various collaborative channels providing essential resources to Korean academic and research institutions and biopharmaceutical companies. Together with Paraxel, KDDF will be able to provide professional consulting services to the Korean research communities to advance research activities and promote important innovation.”
MYLAN Inc’s subsidiary, Mylan Pharmaceuticals Pvt Ltd, has commenced commercial operations in India, starting with the launch of a comprehensive portfolio of 18 anti-retroviral (ARV) products for the treatment of HIV/AIDS. India is home to the world’s third largest population of people with HIV/AIDS, with approximately 2.4 million people living with the disease, of which fewer than 20 per cent have access to treatment. In addition to providing a broad range of ARV products, Mylan will launch several initiatives aimed at educating and supporting medical professionals in their efforts to more effectively treat their patients and helping patients better manage their disease. Mylan expects to enhance its commercial portfolio by adding additional therapeutic categories, and expects to continue to build out its sales force across India to support this ongoing business expansion.
Bristol-Myers Squibb Foundation grants $ 1.6 million to help address type 2 diabetes THE Bristol-Myers Squibb Foundation announced $ 1.6 million in grants to four healthcare institutions in India that will help improve diabetes education, prevention and care and increase healthcare worker capacity in rural and tribal areas and among the urban poor. “Stemming the rising tide of type 2 diabetes,
India will require a concerted and sustained effort at the community level to ensure adults have access to the education, preventive measures and care they need Damonti to effectively self-manage their disease.
The grants we are making today through our Together on Diabetes™ initiative will test new ideas about how diabetes control efforts can be best designed and implemented to help adults
in the warning letter. An inspection report after the last inspection from March 26–30, 2012 indicated that they are satisfied with all the outstanding action points that Dr Reddy’s has submitted. With the satisfactory closure of observations in the warning letter and the lifting of the import alert, Dr Reddy’s can now start importing products to the US from this facility.
in a variety of settings,” said John Damonti, President, Bristol-Myers Squibb Foundation. Mamta Health Institute for Mother and Child in New Delhi, All India Institute of Diabetes and Research, Swasthya Diabetes and Sanjivani Health and Relief Committee in Gujarat will receive the grants.
GCC pharma sales to reach $ 133.2 billion by 2018 PHARMACEUTICAL sales in the six Gulf Cooperation Council (GCC) are set to grow by an average of 7 per cent a year to 2020, reaching a value of $ 10.8 billion from $ 5.6 billion in 2010, Frost & Sullivan said in a new research. Favourable regulatory policies have attracted foreign participants to the market, intensifying competition among top multinationals and a few local companies. The study also forecast that total healthcare expenditures in the GCC will show a CAGR of 10.3 per cent during 2010-18.
Modern Pharma•16-31 Augus t 2012
News, Views & Analysis
Mylan launches generic version of Amidate injection MYLAN Inc recently declared that its business Mylan Institutional has received final approval from the US FDA for its ANDA for etomidate injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials. This product is the generic version of Hospira’s Amidate® injection, which is indicated by intravenous injection for the induction of general anaesthesia. Etomidate injection USP, 2 mg/mL, in
all product presentations has faced recent shortages in the US market. According to IMS Health, currently, Mylan has 169 ANDAs pending FDA approval representing $ 83 billion in annual sales. Further, out of these 35 pending ANDAs are potential first-to-file opportunities, representing $ 25.1 billion in annual brand sales, for the 12 months ending December 31, 2011.
Mylan Institutional, part of Mylan Inc, is a customerfocused business providing a differentiated basket of pharmaceutical products and services, including a broad range of injectable products and SKU’s in unit dose, unit-of-use, and automationready package formats, to institutional customers, which include correctional facilities, specialty pharmacies, veterinary clinics and retail outlets, etc.
Sun Pharma Q1 net jumps 59 per cent on US sales SU N Pharmaceutical Industries, reported 59 percent rise in quarterly net profit substantially beating street estimates, as sales in its key US market surged helped by robust business of Israeli unit Taro Pharma. The company’s net profit rose to 7.96 billion rupees during the fiscal first quarter ended June from 5.01 billion rupees a year earlier. Sales rose 62.5 percent to 26.58 billion rupees it said.
Sun Pharma has decided to spin off its domestic formulation business. It clarified that the spin-off is only to ‘enhance focus on the business and allow for quicker responses to competitive market conditions’. The company said that in the new drug policy of the government, six of Sun’s high-margin drugs come under price control, which will have a significant impact on the company.
Eisai and Arena Pharmaceuticals complete transfer of Belviq® NDA EISAI Inc and Arena Pharmaceuticals, Inc recently announced that Arena has transferred the Belviq® (lorcaserin hydrochloride) NDA to Eisai. The transfer establishes Eisai as the marketing authorisation holder responsible for
regulatory activities in the US related to the commercialisation of Belviq, including pharmacovigilance requirements. Arena will continue in its oversight role for the global development of Belviq while working closely with Eisai
Strides collaborates with Gilead Sciences STRIDES Arcolab Ltd has entered into an in-licensing agreement to collaborate with Gilead Sciences, Inc to promote access to high-quality, low-cost generic versions of Gilead’s HIV medicine emtricitabine (FTC) in developing countries – including fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV
medicines. Under the new agreement, Gilead will provide a technology transfer for the manufacture of emtricitabine, together with funding to assist with investment in process improvements to reduce overall manufacturing costs. World Health Organization guidelines recommend emtricitabine along with Tenofovir Disoproxil Fumarate (TDF), as preferred components of first- and secondline HIV therapy. However, cost is currently a barrier to broadening access to regimens that include emtricitabine when compared to other regimens, including widely used lamivudine (3TC)-based regimens. Arun Kumar, MD & Group VC, Strides Arcolab Ltd, said, “We are pleased to associate with Gilead on this initiative that will provide access of high quality essential anti-retrovirals in the developing markets. This partnership will re-enforce our commitment to provide affordable drugs in the field of HIV/AIDS, tuberculosis and malaria to the low and middle income countries.”
for the joint development plan in the US. “The NDA transfer furthers our commitment to Belviq as we prepare to launch in the US and submit applications for approval throughout the Americas,” said Lonnel Coats, President and CEO, Eisai Inc.
Eisai plans to submit marketing authorisation applications based on the NDA to the health authorities throughout the territories in North and South America for which it currently holds commercialisation rights, including Mexico, Brazil and Canada.
Modern Pharma•16-31 Augus t 2012
News, Views & Analysis
Cipla to invest ` 500 crore to set up API facilities CIPLA plans to invest ` 500 crore for setting up API facilities at Patalganga, Bengaluru and Kurkumbh. According to the Company’s annual reports, the setting up of these facilities is expected to be completed by 2012-13. The report said that several dosage forms and APIs manufactured at the company’s facilities continued to enjoy the approval of major international regulatory agencies such as US FDA
and WHO. The company is actively involved in developing biosimilars/bio-therapeutic products through its partners in China. It is expected that the clinical trials on these drugs will be completed in
2-3 years. Subsequently, the products will be launched in India. The company’s venture into stem cell-based products is under progress with a major investment in Stempeutics Research Pvt Ltd, Bengaluru. At present, clinical trials for regulatory approvals for certain therapeutic areas are underway in India and Malaysia. In addition, the report stated that the launch of the stemcell-based products is expected in 3 years.
Enaltec Labs develops portfolio of technologically challenging molecules ENALTEC Labs Pvt Ltd has recently recorded phenomenal growth in the past few years. The company’s strength lies in continuous innovation and research. Enaltec is currently working on APIs of molecules, which are in Phase III clinical trials (not approved), thus creating the Intellectual Property (IP) to value itself. Enaltec is also working on and creating IP for scalable and cost effective processes on the molecules that are approved but having
generic entry dates delayed up to post 2016s. “With this strategy, Enaltec is able to offer these
products immediately to their associates for the development of their finished dosage formulations well in advance so that they are able to launch the formulations immediately upon the expiry of the patent. We have developed a portfolio of niche and technologically challenging molecules, thus carving a special space in global pharmaceutical industry”, said Anand Shah, MD & CEO, Enaltec Labs Pvt Ltd.
Mylan launches generic Singulair® tablets and Singulair® chewable tablets MYLAN Inc announced that its subsidiary Mylan Pharmaceuticals has received final approval from the USFDA for its ANDA for montelukast sodium tablets, 10 mg, the generic version of Merck’s Singulair® tablets. Mylan also received final FDA approval for its ANDA for montelukast Sodium chewable tablets, 4 mg and 5 mg, the generic version of Merck’s Singulair® chewable tablets. These products are indicated for the prophylaxis and chronic treatment of asthma in patients two years of age and older, for the
prevention of exercise-induced bronchoconstriction in patients 15 years of age and older, and for the relief of symptoms of seasonal and perennial allergic rhinitis in patients two years of age and older. Montelukast Sodium tablets, 10 mg, had US sales of approximately $ 3.7 billion for the 12 months ending June 30, 2012, and montelukast Sodium chewable tablets, 4 mg and 5 mg, had US sales of approximately $ 1.2 billion for the 12 months ending June 30, 2012, according to IMS Health. Mylan has begun shipping of these products.
Strides Apr-Jun net up at ` 91 crore STRIDES Arcolab posted a rise of 31.88 per cent in its consolidated net profit at ` 91 crore for the second quarter ended June 30, 2012, over the same period of previous fiscal. The company had posted a net profit of ` 69 crore for the same period of previous fiscal. Net sales of the company stood at ` 508.29 crore for the second quarter ended June 30, as compared to ` 581.25 crore
during the same period of 201112 fiscal. “It has been a pleasing quarter where both pharma and Agila have delivered superior operating results and additionally addressed key shortages in the US injectables market with specific product launches,” Arun Kumar VC & Group CEO, Strides Arcolab Ltd. Around 40 products willbe launched in the next 2 years, he added.
Novartis India to send 3 students to participate in International BioCamp in Switzerland WITH a view to provide an international work exposure and hands-on experience on the multifaceted world of pharmaceuticals and biotechnology, Novartis India recently organised a three day seminar-cum-camp called Novartis Biotechnology leadership camp (BioCamp) in Hyderabad from July 30 to August 1. The company through this initiative offered 49 students drawn from 130 leading Indian universities hands-on experience on latest pharmaceuticals and biotechnology know how. BioCamp is a pioneering seminar organised by Novartis that brings young, talented
students from diverse faculties and different universities closer to the field. During the event the students go through a rigorous judging process before they are selected to participate in the country BioCamps. Out of all the students three winning students were given a chance to participate in the International Novartis Biotechnology Leadership Camp taking place at the Novartis Campus in Basel, Switzerland from August 26 to 29, 2012. Hyderabad based Esha Kakkar, an alumnus of the Indian Institute of Business, took top honours along with Dr Girish Naik of Christian Medical College,
Vellore and Sagar Laygude of IIT - Madras, Chennai to get the chance to participate at the international event. Topics covered during this three-day seminar included clinical drug development, entrepreneurship, branding
and commercialisation, the role of intellectual property rights, ethics and career opportunities in the pharmaceutical world. As part of the program participants worked on a case study to address diabetes as a disease that impacts a large section of the Indian population. Speaking on the occasion, Ranjit Shahani, VC and MD, Novartis India said, “Novartis appreciates the opportunity to play a role in bringing top talent closer to the pharma industry and to partner with academia. BioCamp provides students on the threshold of their careers insights to the pharmaceutical and biotechnology industries. It offers bright minds a platform
to interact with leaders in the field and network with students coming from different faculties across the country.” The Novartis Biotechnology Leadership Camp (BioCamp) has been held annually in Asian countries since 2004, starting in Taiwan as a local event. It has since grown impressively in to a global event. Last year’s International BioCamp was held in Basel, Switzerland. Around 60 students from around the world are expected to participate in the global BioCamp being held at the Novartis Campus in Basel, Switzerland from August 26 to 29, 2012.
Mylan signs agreement with Gilead MYLAN Inc recently announced the establishment of a new agreement between its subsidiary Mylan Laboratories Ltd and Gilead Sciences Inc. Under this agreement, Mylan has licensed the rights to produce and market generic versions of Gilead HIV/ AIDS therapies containing emtricitabine, including single and fixed-dose combinations. Emtricitabine is marketed by Gilead under the brand name
Emtriva®, and a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate is available under the brand name Truvada®. Emtricitabine also is a component of the ‘Quad,’ an investigational medicine that combines four Gilead medicines in a once-daily, single tablet regimen for the treatment of HIV-1 infection. Heather Bresch, CEO, Mylan, commented, “Access to affordable
medicine continues to be an acute need in tackling HIV/AIDS, and once again we are delighted to be collaborating with Gilead in these efforts. Mylan is focussed on expanding access to highquality treatments to those in need around the world. Partnerships like this one ensure that patients in developing markets have access to important, recommended treatment options, like those containing emtricitabine.”
Further, Mylan Laboratories obtained non-exclusive rights to produce and market active pharma ingredients and finished products, including generic versions of Viread® (Tenofovir Disoproxil Fumarate or TDF), Truvada® (emtricitabine/ tenofovir disoproxil fumarate) and other TDF-based combinations in over 100 developing countries including India.
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News, Views & Analysis
Researchers to develop gel to protect women from HIV and HSV infections A new grant from the National Institute of Allergy and Infectious Diseases (NIAID) will support the development of a topical microbicide gel for drug delivery. The innovative gel formulation will be a combination therapy against Human Immunodeficiency Virus (HIV) and Herpes Simplex Virus type 2 (HSV-2) infections in women. Every day, more than 3,000 women around the world are newly infected with HIV, and it is the leading cause of death in sub-Saharan Africa. Of the 33.3 million people living with HIV/ AIDS across the world, 22.5 million are in Africa. HSV-2 is a global epidemic and affects up to 80 percent of the female population in Africa. As part of the grant, SRI International researchers will develop and test a prototype bioadhesive formulation for sustained delivery of the antiviral drugs tenofovir and acyclovir to the vaginal surface. Because chronic HSV-2 infections have been shown to speed the progression of immunodeficiency
Pfizer penalised for corrupt payments in China PHARMA giant Pfizer has agreed to pay $ 60.2 million (HK $ 466.8 million) to settle a US government probe of illegal payments to win business overseas including China. According to a complaint filed by the Securities and Exchange Commission in US District Court for the District of Columbia, Pfizer’s misconduct dates back to 2001. Company employees bribed foreign officials to use Pfizer’s products and boost prescriptions. The improper payments were made to officials in Russia, Bulgaria, Croatia, Kazakhstan, Serbia, Czech Republic, China and Italy. In China, for example, Pfizer employees hosted ‘club-like meetings’ with recreational and entertainment activities for government doctors who wrote a lot of prescriptions. The company also created programs under which government doctors could accumulate points based on the number of prescriptions they wrote for Pfizer products. The points could be redeemed for gifts ranging from medical books to cell phones, tea sets and reading glasses. Pfizer in 2004 became the first pharmaceutical company to volunteer information about past wrongdoing to the Justice Department, but the case has taken years to resolve. Pfizer said, “The actions that led to this resolution were disappointing, but the openness and speed with which Pfizer voluntarily disclosed and addressed them reflects our true culture and the real value we place on integrity and meeting commitments.’’ Pfizer admitted that between 1997 and 2006, it paid more than $ 2 million of bribes to government officials in Bulgaria, Croatia, Kazakhstan and Russia, and admitted that it made more than $ 7 million in profits as a result of the bribes, the Justice department said. Pfizer HCP’s penalty was reduced because of Pfizer Inc’s cooperation in the ongoing investigation of other companies and individuals, the department said.
disease, researchers are focused on developing a microbicide that prevents both HIV and HSV-2 infections. “The inexpensive and easy-to-use combination therapy in development could help contain the spread of HIV and HSV, and possibly other sexually transmitted diseases,” said Gita Shankar, Director - Formulations R&D, SRI Biosciences. She added, “One of the strongest benefits of a topical gel formula is that it can offer protection when options such as condoms are unavailable or unacceptable.” The awarded grant is for two years with a possible extension of three additional years. Development work will focus on creating a combination therapy that will limit the risk of drug resistance, while providing women with safe and sustained drug delivery. This research will be supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number R21AI098658.
Astellas and Tokyo Institute of Technology sign agreement ASTELLAS Pharma and Tokyo Institute of Technology have announced a joint research agreement for drug discovery research leveraging Tokyo-Tech’s TSUBAME2.0 supercomputer to discover candidates for the treatment of diseases caused by protozoan parasites. The joint research aims to contribute to the drug discovery to treat diseases caused by protozoan parasites, such as leishmaniasis, chagas disease and sleeping sickness in neglected tropical diseases. According to the agreement, a research group at the Global Scientific Information and Computing Center, TokyoTech and Astellas will co-operate in drug discovery for the treatment of diseases caused by protozoan parasites. In the two step research, the first step includes data mining of public information such as patents and published articles to obtain the knowledge about the drug discovery for the treatments for diseases caused by protozoan parasites. In-silico screening will be performed to identify
compounds, which are predicted to have anti-protozoan activities, in the second step. Tokyo-Tech will be responsible for data mining and
Global Scientific Information and Computing Center, Tokyo-Tech and Astellas will cooperate in drug discovery for the treatment of diseases caused by protozoan parasites.
for in-silico screening calculations of commercially available compounds, while Astellas will be responsible for preparing input data for data mining, selecting and listing of compounds to be evaluated based on the in-silico screening calculations.
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News, Views & Analysis
In Brief Drug counterfeits in China detained POLICE in China have detained almost 2000 people during a national blitz on fake pharmaceutical drugs. The Public Security Ministry said that more than 180 million dollars worth of counterfeit products have been seized, and 1100 production facilities have been destroyed. The haul of fake pharmaceuticals included drugs, which claimed to manage diabetes, high blood pressure and rabies.
Texas fights prescription drug abuse with e-data THE Texas Department of Public Safety (DPS) has launched an online program to track prescribed painkillers and other controlled substances in a bid to fight a rising prescription drug problem. DPS began making the database available online to a limited group in June and is expanding and including more specialists and investigators. Although some hope it will lead to fewer fatal drug overdoses, the American Civil Liberties Union has concerns about privacy and correcting potential errors in the information.
Rising demand of drugs contribute to the increase in the pharma market growth: Report REPORTRESERVE recently announced the inclusion of its new report published by Infiniti Research. TechNavio’s analysts forecast the global pharma market to grow at a CAGR of 7 per cent over the period 20112015. According to the report one of the primary factors contributing to this market growth is the rising demand of drugs in the emerging markets. Additionally, the global pharma market has also been witnessing a paradigm
shift towards biologic drugs. However, looking forward the patent expiration of top-selling drugs could pose a challenge to the growth of this market. TechNavio’s report, the Global Pharmaceuticals Market
2011-2015, has been prepared based on an in-depth analysis of the market with inputs from industry experts. The report covers the Americas, and the EMEA and APAC regions. In addition the report includes a discussion of the key vendors operating in this market. The primary vendors dominating this market space include Merck and Co Inc, Novartis AG, Pfizer Inc, Sanofi SA, and Roche Holding Ltd.
Glenmark Generics receives final ANDA approval for montelukast Sodium tablets GLENMARK Generics Inc, USA has been granted final ANDA from the US FDA for montelukast Sodium tablets, 10 mg. Glenmark will commence distribution of the product immediately. Montelukast Sodium tablets are Glenmark’s generic version of Singulair® by Merck & Co, Inc, indicated for the treatment of prophylaxis and chronic treatment of asthma. For the 12 month period ending March 2012, Singulair® garnered annual sales of $ 3.5 billion according to IMS Health.
Cipla PAT grows to ` 401 crore for Q1 CIPLA Ltd recently announced its unaudited financial results for the quarter ended June 30, 2012 (Q1). The gross revenues grew by 23.6 per cent to ` 2012 crore, up from ` 1628 crore in Q1 FY11-12. And the profit after tax grew by 58.2 per cent to ` 401 crore during Q1 FY1213, up from ` 253 crore (Q1 FY11-12). Seeing good sales and profits, the operating margin increased by 47.1 per cent and is at 28.0 per cent of income from operations during Q1 FY12-13 as compared to 23.5 per cent during Q1 FY11-12.
Eli Lilly to double insulin production capacity over next 5 years ELI Lilly has announced ambitious plans to double production capacity of insulin and insulin devices by 2017 in a bid to continue growing its diabetes portfolio. But the global pharma company plans on boosting production without building any new manufacturing plants or increasing outsourcing. Instead, it intends to increase output at existing sites by ‘implementing a process technology agenda’ to standardise each plant, giving it them the capabilities
to produce the full range of insulin in its portfolio and pipeline. Kelley Murphy, Director - Communications, Lilly Diabetes said, “We are working towards a flexible
model that will enable us to manufacture more in the same facility. This flexibility will translate into increased production and capacity.” As well as increasing flexibility, the move will generate savings that are expected to drive margin improvements in the company’s insulin business. In fact, by removing the capital costs of new plants and reducing outgoings over time, Lilly bosses claim the move holds the same value as a blockbuster drug.
Julphar signs insulin deal with US-based firm UAE-BASED pharmaceutical company Julphar, has entered an exclusive insulin deal with EMD Millipore, the Life Science division of Merck KGaA of Germany. As per the agreement, EMD Millipore will sell recombinant human insulin manufactured by Julphar Diabetes. The insulin is of non-animal origin and will be marketed under EMD Millipore’s CellPrime brand name. The new partnership is expected to be a merchandising collaboration on several pharmaceutical products with cardiovascular disease, the main health problem to be targeted.
UAE: Zero tolerance to JWH drug CHIEF Prosecutor of the Dubai Drug Prosecution, Walid Faqai, recently warned the public against carrying, peddling or using JWH, a synthetic drug that can cause hallucination, confusion, imagining of things and bouts of panic and is commonly known as spice, stressing it was a crime that would be dealt with no tolerance. Faqai said, “The Dubai Drug Prosecution is the first in the country to refer an Asian man to the Court of First Instance on the crime of possessing and using JWH.”
Workshops organised on pharmacy ranking system A series of workshops has been conducted by the Health Authority-Abu Dhabi to familiarise licensed pharmacists in the emirate of Abu Dhabi with a new ranking system for pharmaceutical facilities. The system, titled JAWDA, aims to enable residents to choose between pharmacies based on the level and quality of service offered. Pharmacies will be required to display their ranks according to the system by 2013.
Strides Acrolab receives FDA nod for Oxaliplatin STRIDES Arcolab recently said its subsidiary Onco Therapies Ltd has received final approval from the US FDA for its generic version of Oxaliplatin injection in strengths of 50 mg/10 ml and 100 mg/20 ml used for treating cancer.
Accu-Break in pact with Alembic ACCU-BREAK Pharmaceuticals, Inc (ABP) has entered into a development and license agreement with Alembic Pharmaceuticals Ltd, Gujarat, to develop new brand products that will use ABP’s innovative Accu-Break tablet technologies. ABP’s patented Accu-Break tablets can be split easily by hand into exact smaller doses to provide maximum flexibility, and to make it easier and safer for patients and caregivers to adjust their dosage. The first product that ABP will seek FDA marketing approval for is an Accu-Break-formatted
version of the popular anticoagulant medication warfarin (Coumadin). “We are delighted to be working with a leading pharmaceutical
company in India that is vertically integrated and has the ability and expertise to develop and manufacture pharmaceutical products for the US market. Together, we are looking forward to filing the first of what we anticipate will be many 505(b)(2) NDAs for products utilising our patented Accu-Break technologies in combination with Alembic’s broad base of active pharmaceutical ingredients and formulations,” stated Elliot F Hahn, Executive Chairman, AccuBreak Pharmaceuticals, Inc.
Bio-Rad, Myriad RBM to develop multiplex biomarker kits BIO-RAD Laboratories (BIO) and (BIO.B) and the wholly owned subsidiary of Myriad Genetics (MYGN), Myriad RBM, have joined forces to develop and distribute immunoassay kits. As part of the agreement, Myriad RBM will provide Bio-Rad with distribution rights for research purposes, to the catalogue of quantitative multiplexed immunoassays present to run on the Bio-Plex 200,Bio-Plex 3D, and Bio-PlexMAGPIX instruments. Brad Crutchfield, Group Vice President and Group Manager, Bio-Rad Life Science, said, “The companies are able to provide hundreds of
biomarkers for both human and non-human panels to their Bio-Plex multiplex immunoassay system menu. Moving forward, Myriad RBM and Bio-Rad will collaborate to design new products to meet the evolving requirements of our customers.” Adding to this Craig Benson, President, Myriad RBM, said, “Our partnership with Bio-Rad will help researchers and clinicians on the front lines of medicine to develop biomarker profiles that may predict, detect, or monitor disease progression in an effort to optimise treatment and improve patient care.”
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News, Views & Analysis
South African pharma market to reach $ 7 billion by 2018: GBI Research GBI Research’s recent report, ‘Emerging Pharmaceutical Market in South Africa to 2017 - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process’ provides in-depth analysis of the trends, issues and challenges in pharma market in South Africa. South Africa’s pharmaceutical market is one of the most attractive markets in Africa. Some of the main reasons for its rapid growth are the availability of costeffective and skilled labour, high quality infrastructure, and the introduction of the South African Health Products Regulatory Authority (SAHPRA). Most of the local drug manufacturers and distributors are in the hands of big international pharmaceutical firms. GBI Research valued the South African pharmaceutical
market at $ 3.8 billion in 2011, and expects it to reach $ 7 billion by 2018 at a CAGR of 9.2 per cent. South Africa’s healthcare sector is set to witness a number of new healthcare reform
Government reforms have encouraged the manufacture and use of generic drugs as a tool to limit drug expenditure and provide lowcost effective public healthcare.
plans in the future, with the primary objective being to reduce the growing drug expenditure by increasing the use of generics. Further, the
LifeCell celebrates milestone achievement of 50,000 customers LIFECELL International, India’s largest and most accredited stem cell bank, recently announced a milestone achievement of successfully preserving 50,000 umbilical cord blood stem cell units in its preservation centre and laboratory located in Chennai. Stem cells derived from the umbilical cord are known to have the potential to treat over 75 serious medical conditions. More and more expectant parents are now banking
with LifeCell to collect and preserve their baby’s umbilical cord stem cells at birth for potential need in the future. LifeCell has attained its stature as India’s largest stem cell preservation company through its persistent educative and promotional initiatives to create awareness on the need for stem cell preservation. Commenting on the milestone achievement, Mayur Abhaya, MD and CEO, LifeCell, said, “When we launched our services in 2004 the medical fraternity was not even aware of the concept of stem cell banking. It was our responsibility to create awareness among both the doctors and the expectant parents about its enormous scope in the future. Our 50,000 member milestone is recognition of that effort. I am pleased that we are now offering this valuable service pan India and increasingly in other neighbouring countries too.”
report shows that generics accounted for over 60 per cent of the volume of the pharma market in 2011. In addition, the government reforms have encouraged the manufacture and use of generic drugs as a tool to limit drug expenditure and provide low-cost effective public healthcare. Further, the report shows the analysis of the leading segments within the South African pharma industry, key drivers and restraints impacting the market, competitive benchmarking of leading companies in the pharma and CRO markets in South Africa, etc. The companies mentioned in this report are Aspen Pharmacare, Adcock Ingram, Cipla Medpro, Sanofi, Pfizer, Roche, Ranbaxy, GlaxoSmithKline, Merck & Co, Novartis, etc.
In Brief Mindteck reports Q1 FY 2012-13 results MINDTECK (India) Ltd’s consolidated revenues for the first quarter ended June 30, 2012 stood at ` 63.75 crore as against ` 52.50 crore for the corresponding quarter of the previous year, registering a growth of 21.41 per cent over the previous year’s quarter. Wayne Berkowitz, CMD, Mindteck, said, “Despite the unsatisfactory numbers this quarter, there are distinct signs of improvement. Based on the initial investments, we are seeing positive results at a number of large clients and attracting new clients as well. From a cost/expense standpoint, we are looking at every expense line item to determine where and how much we can save.”
Abbott receives FDA approval for Omnilink Elite® ABBOTT recently received the US FDA approval for the Omnilink Elite® vascular balloon-expandable stent system for the treatment of iliac artery disease that affects the lower extremities. The FDA approval is supported by positive clinical data from the MOBILITY study that demonstrated that Omnilink Elite is safe and effective, including when used for patients who are difficult to treat due to complex disease resulting from severely calcified lesions.
Watson Laboratories’ inhalation suspension approved WATSON Laboratories has received the US FDA approval for its ANDA for budesonide inhalation suspension 0.25 mg/2 mL and 0.5 mg/2 mL unit-dose ampoules, the generic equivalent to AstraZeneca’s Pulmicort Respules.
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News, Views & Analysis
Life Technologies and SATuRN partner Bio-Rad introduces new Bio-Plex Pro™ cell signaling assays in sequencing-based surveillance LIFE Technologies Corporation has collaborated with SATuRN, the Southern African treatment and resistance network on sequencing-based diagnostics for HIV-infected individuals. Anti-retroviral (ARV) drugs are becoming increasingly available in the developing world, due to facilitation by both governmental and NGOs, as well as reductions in price and international trade restrictions by pharma companies. Resistance to these drugs develops in many HIV-infected individuals, and resistance is therefore
coming to the forefront of the global health agenda. Further, resistance can be monitored by genetic sequencing of two viral genes, but current costs have made routine use prohibitive in most African countries. Life Technologies has developed together with SATuRN a simple-to-answer solution for ARV resistance testing, which is being made
Absorption Systems launches new BCRP assay system ABSORPTION Systems has launched new assay for the human Breast Cancer Resistance Protein (BCRP) transporter. The new assay will enable drug developers to test new drug candidates for interactions with BCRP, which is involved in drug clearance, resistance of tumours to anti-cancer drugs, and drug-drug interactions. The Company’s cell biologists have over-expressed BCRP
in a stable manner in the MDCK cell line, and created BCRP-MDCK cells, which forms basis of a sensitive test system to screen new drug candidates for inhibition of BCRP. Ismael Hidalgo, Chief Scientist, Absorption Systems, said, “The Company is pleased that it is at the point where it can use the new cell line to help customers develop safer, more effective drugs.
available to African partners at a highly economic cost per test. The test can be run on Life’s Applied Biosystems line of Sanger sequencing instruments, which are broadly installed in African hospitals and HIVtesting centres. Commenting in this regard, Ronnie Andrews, President - Medical Sciences, Life Technologies, said, “Drug resistance testing is an essential cornerstone of clinical practice in the developed world. We are proud to partner with SATuRN to make resistance testing possible for a broad base of HIV-infected patients in Africa.”
BIO-RAD Laboratories, Inc recently announced the launch of its new Bio-Plex Pro cell signaling assays for detecting phosphorylated and total proteins involved in key intracellular signaling pathways. The Bio-Plex Pro immunoassays take advantage of the magnetic bead workflow to simplify assay preparation and improve precision. The 34 magnetic bead– based immunoassays (23 phosphoprotein and 11 total protein targets) have been reformulated and optimised to provide exceptional sensitivity, high specificity and improved performance over western blot. They are available in singleplex
Bio-Plex Pro immunoassays
sets and custom premixed allin-one kit formats. Bio-Plex Pro cell signaling assays can be used with lysates derived from adherent cells, suspension cells, or tissue samples. This appeals to researchers in areas such as cancer/oncology, inflammatory and autoimmune diseases, metabolic diseases, neurological disorders, cardiovascular disorders and toxicology.
Vacuum steriliser ADV for porous loads and liquid products THE steriliser ADV of Bosch Packaging Technology is suited for vacuum sterilisation of porous loads, as well as for sterilisation of liquids according to the steam/ air mixture process. The combination of both processes on one machine offers high flexibility and underlines the competence of Bosch in product and equipment sterilisation. The autoclave
sterilisation portfolio includes standard modules as well as customised solutions for the pharmaceutical sterilisation
of products and equipment. “Our systems achieve an availability of up to 99.9 per cent for the sterilisation of single-use contact lenses. With the steriliser ADV, we combine our core competencies in an especially flexible and versatile machine which ensures high availability and process security,” explained Alfred Kaliwoda, General Manager, SBM. “
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In Conversation With
I wanted to set up something similar to Infosys, which would be more value based and professionally managed …informs Apurva Shah, Group MD and Co-Founder, Veeda Clinical Research. Armed with an MBA in International Finance & Management from USA, and a passion to create something unique of his own led to the birth of Veeda Clinical Research. He narrates the evolution of the sunrise industry and charts the strategy he followed for being successful. Excerpts…
Shibani Shah firstname.lastname@example.org
Tell us about the evolution of Veeda. It might sound funny, but I read an article and it was about how India is suited to take advantage of this sunrise (clinical research) industry. This was because conducting clinical research in India would put us in a unique position compared to China as this industry is more of a knowledge-based and value-added industry similar to IT. This got my excitement and the reason Veeda was started was not just because I wanted to do another business or make money, but because I wanted to set up something unique. By God’s grace, I was financially sound then and wanted to create something which was my own, but still separate from the family. I wanted to set up something similar to Infosys, which would be more value based and professionally managed. This was how I started working on Veeda and it was established in 2005. What differences do you see in the clinical research scenario in India and abroad? East and west both have advantages and disadvantages. There are specific areas of difference. First, the western people have been into research for a long time compared to India. And, in India the whole education system has been designed to actually follow what has been told to us and
we are a lot better in following those rules and guidelines up to the last peak. This proves as a benefit as we can follow the guidelines and tasks driven by the SOPs in a straight forward manner. On the other side, the western culture of reasoning and questioning helps western companies to think out of the box and innovate that actually drives them to conduct research in a more effective manner. Thus, India has been very strong in generics and continues to become stronger in generic research along with backward engineering and understanding the process, but when it comes to doing absolutely hard core research on new drugs it is not that easy.
There is great competition on the generic front. We are trying to go for more number of value-added products with greater efficiency.
Evolution and future of the clinical research industry. I believe that the research industry has dynamically changed from what it was ten years ago. A lot of concepts that were considered as a trigger or guaranteed way of working have changed. Pharmaceutical companies have changed in terms of market capitalisation. Again this scenario changed after the 2008 meltdown where
Beyond the boardroom... A cause that he strongly supports: Each one Teach one (He is a Manging Committee Member at the organisation). I believe that knowledge and education can be a solution to a lot of problems. In India, the only way to solve our problems such as population is via education. At Veeda, just empowering people and spreading a culture of knowledge, we have been able to change the lives of many. Our employees who started with a bicycle or motorbike in 5 years have been able to afford a house, and educate their children. Education allows people to think a lot bigger. And honestly, that is the way we can change our country’s fortune and take advantage of a huge high IQ and high passion workforce created. Hence, for me education is the most critical thing.
the governments of different countries were struggling to expand and it affected the production of goods greatly. This has resulted in a drastic drop in the market capitalisation and funds, and therefore, it has also become important to rise and re-calculate the terms between the governments. As a result, the new drug discovery and developmental processes are being questioned and challenged. Its efficiency is being looked at closely by multinationals. Therefore, they are looking at avenues that are more efficient. The regulators are also looking for more data to check for safety of the products. The challenge is on both the sides and therefore I believe that new avenues in early stage development will evolve. We need to engage in more patient studies rather than studies on healthy volunteers. There is great competition on the generic front. We are trying to go for more number of value-added products with greater efficiency. Although high quality still remains a priority, efficiency has also become a critical component of the developmental model. Outsourcing has developed greatly and the trend is expected to continue in future. One of the reasons being that the large pharmaceutical companies have reduced their workforce quiet substantially and they will have to outsource more. They are also likely to get fussier about the requirements and efficiencies of products against their money spent. They are also likely to demand for more expertise from the CROs and hence to improve their efficiency CROs can have the real experts in the particular domain of research rather than have generalist manpower. You are being seen as one of the best entrepreneurs in India and have won ‘Entrepreneur of the Year’ by Bio Spectrum Magazine. What is your advice for individuals who dream to be in your shoes? I believe that having a passion for something is very critical, and hard work obviously has no substitute. Looking at the bigger
picture is very important for an entrepreneur. It is more critical to believe in the venture than looking at the bottom line, profitability or financial dream because if you look at the financial
I believe that the latter part is much more fulfilling because you do the things in the right way and feel successful in spite of achieving or not achieving the financial results and eventually you will be led to other targets.
It is more critical to believe in the venture than looking at the bottom line, profitability or financial dream, because if you look at the financial dream you will make the wrong decisions in the short term.
Advice for acquisitive companies... Rather than thinking of globalisation in a limited manner, one should look at the customer needs and how the industry is developing and accordingly find a solution, which is global in nature. We can look at developing something in a certain country or certain cluster rather than just ape any other company or industry. Just to put into perspective, the pharma industry is looking at a unique kind of solution to solve its problem and therefore we believe that having the right solution from a different set of countries, which is an expert in the field, is important. We went about filling up these gaps rather than putting our fingers on different parts of the world. We wanted to spread beyond India and create a market close to the customers. Therefore, we practiced globalisation as a strategy, which we think was well suited to the customers need.
dream you will make the wrong decisions in the short term, which will never let you see the pot of gold at the end of the rainbow. And, being a team player is absolutely important because without it anything is achievable. What does success mean to you? Success is actually divided into two parts. One is to get success in terms of actually achieving a target and other is feeling the satisfaction of completing what you were actually supposed to in a successful manner irrespective of the result.
Modern Pharma•16-31 Augus t 2012
South East Asian countries Shibani Shah email@example.com
fter the success of IT and BPOs, the next big thing expected to happen in healthcare was clinical trial outsourcing. Around 2000, MNCs were ready to convert South Asia into a clinical trial ‘Petri’ dish. The availability of a large patient pool and reduced costs as compared to western countries lured the MNCs to carry out their clinical trials in South Asia. The lack of regulations, longer time for approvals and reported adverse unethical events turned the attention of big pharmas away from India. By 2005-2006, India and China had developed as hotspots for conducting trials for multinational pharma companies.
Next hub for outsourcing? has increased the number of patients available for diabetes and obesity drug trials. Due to the disease prevalence, the number of available patients that fit the protocol parameters and the ease of access to those patients, more and more studies of this nature are being conducted in South East Asian countries.”
Factors affecting growth As per a report by GBI Research, the global R&D outsourcing market in 2010 was 25.3 per cent of the total pharmaceutical R&D expenditure. The expenditure is estimated to increase at the rate of 5 per cent annually and is expected to reach 37.1 per cent of the total R&D expenditure by 2018, as per the same report. Companies are looking to cut down the time for launch of drugs along with a reduction in the expenditure on R&D. Hence, they look up to outsourcing as the best alternative option. The size of the global Contract Research Organization (CRO) market by March 2012 was estimated to be at $ 27 billion, with an annual growth of 15 per cent, according to a Frost & Sullivan report. This growth is driven mainly by the Asian and Eastern Europen markets. Dr Malcolm Burgess, Executive Vice President, Asia Pacific, Icon Plc, adds, “The majority of originating work
The biggest single driver for conducting trials in South East Asia is the availability of large numbers of clinically naïve patients. Dr Malcolm Burgess Executive Vice President, Asia Paciﬁc, Icon Plc
With cost of R&D being unaffordable in western countries, pharma giants outsource their services to the South Asian countries that has led to the emergence of this region as a hot spot for conducting clinical trials and contract research. continues to come from the US and EU-based pharmaceutical companies. However, we see an increased trend for originating work particularly in the biosimilar space coming from Korea and Taiwan, and both biotechnology and pharmaceutical work originating from China. The latter are generally smaller studies intended for the local market.” The South Asian countries have a large population of about 545 million. The availability of a large patient pool in South Asian countries backed with strong government support draws the attention of pharma companies to outsource in this region. Dr Burgess explains, “The biggest single driver for conducting trials in South East Asia is the availability of large numbers of clinically naïve patients.” Asian countries are said to be about 20-30 per cent cost effective as compared to their western counterparts. Dr Burgess adds, “The cost of executing studies in Asia Pacific is lower than the traditional cost of developing drugs solely using patients from Europe and the US.” The developed countries have stringent healthcare regulations. On the contrary, the regulatory bodies in many Asian countries such as Singapore, South Korea
and Taiwan have adopted an FDA flavour to their practices that make them an ideal choice for outsourcing. Dr Burgess explains, “While regulatory start up times
The availability of a large patient pool in South Asian countries backed with strong government support draws the attention of pharma companies to outsource in this region.
can be challenging for some countries, the ability to recruit large numbers of patients once the sites are up and running is a major benefit in terms of meeting aggressive timelines for the overall regulatory approval of the compound. In essence, start up times can be longer than in Europe or the US but this additional start up time is more than made up for by the ability to rapidly recruit patients.”
Benefits galore The developed infrastructural capabilities give them an edge over the other hubs. Dr Burgess elaborates, “Over the last decade, the GCP certified sites have been established to support
enrolment of patients into clinical trials in South East Asia.” The South East Asian countries are currently at different stages of development in their healthcare systems. There are different regulatory frameworks and institutional review boards in different countries. Most regulatory agencies have clear guidelines for clinical study application approval and timeline commitments. He adds, “Singapore and Malaysia’s governments have been playing an important role in investing and building local clinical research networks to strengthen therapeutic expertise. There are many Key Opinion Leaders (KOLs) in South East Asia, who have been well trained in key Centres of Excellence in the US, Europe and Asia.”
Types of drugs being tested The drugs for key therapeutic areas tested in South East Asia include infectious diseases, such as chronic Hepatitis B or C and HIV. Along with these, several oncological indications such as hepatocellular carcinoma and neurological conditions such as epilepsy and cardio metabolic diseases are also tested. Dr Burgess adds, “South East Asia has also had a lot of western influence in terms of lifestyle and diet, which
According to BioSpectrum Asia survey 2011, the Singapore clinical trials market is expected to grow to over $ 166 million by 2015 with more than 80 per cent of trials being of international origin. The protection of Intellectual Property (IP) is critical for drug development and Singapore ranks third in the World Economic Forum’s Global Competitiveness Report 2010 – 2011 in this aspect. Dr Burgess adds, “Singapore is reputed for its excellent clinical research facilities and capabilities. The country plays a strategic role in developing GCP in Asia. Singapore is also ideal for complex oncology trials requiring sophisticated diagnostics equipment for patient diagnosis, treatment and follow-up, which most hospitals can offer.” While Singapore is the king, Korea, Taiwan and Japan are the other players in the market. China remains a choice due to large population and patient availability. Burges suggests, “When deciding which countries are appropriate, it depends on many factors such as the disease prevalence, indication, type of treatment, standard of care, regulatory and logistical obstacles, etc. These factors combined with the overall population determine which are the ideal countries for any given drug development plan.”
Upcoming hub With patent cliffs the outsourcing market is further going to increase. Dr Burgess says, “We are seeing an increase in the outsourcing of various aspects of clinical development to CROs and we expect to see this trend increase as the industry matures and the CROs in the region gain experience and expand their client base.” While outsourcing is leading to the developing South Asian countries, these countries are gradually coming up with their own innovation as well. The question at the end of it is, are the developing countries being exploited due to their under developed healthcare systems?
Modern Pharma•16-31 Augus t 2012
Opportunities and challenges for Indian CROs Chandreyee Bhaumik firstname.lastname@example.org
ccording to various reports, India is fast emerging as a favoured destination for clinical trials by global pharma and biotech companies that are looking for partnerships or setting up new operations. Clinical trial industry in India touched $ 400 million in 2010, up from $ 230 million in 2008 and is expected to touch $ 1.09 billion by 2014. The cost of conducting clinical trials in developing countries like India and China is far lower when compared to their developed counterparts. There are several reasons for this. The reports show that easy access and availability of a large, diverse population with vast gene pool along with lower cost of technical services resulting into lower per patient trial cost are few of them. Additionally, India also has the advantage of having a talent pool of highly trained medical professionals (physicians, nurses and technical personnel); several world-class medical facilities along with well established IT infrastructure; a favourable IPR environment (post signing the World Trade Organization (WTO) agreement) and use of English as the primary business and medical language. The reports show that the Indian contract research market stood at $ 0.9 billion in 2009 and is expected to touch $ 3.4 billion in 2012, reflecting a Compounded Annual Growth Rate (CAGR) of over 55 per cent (2009–2012).
End of a dream run...
While clinical trials from India still remains a huge potential opportunity, the business closures and materialisation of large scale deals have been slow. Nidhi Saxena President & CEO, Karmic Lifesciences
Contract Research Organisations (CROs) provide support to pharma and biotech industries in the form of research services outsourced on a contract services. But today, CROs do not seem to be at its best time. A quick look at the present scenario of the Indian CROs. these questions were answered then I do think we would have got rightful position for CROs in the world. We have good clinicians, physicians, surgeons, pharmacists, intelligent resources, good number of patients, relatively low cost of operations! Thus, everything in context is available. We need to look at this point in totality.”
The brownie points!
Sustaining afloat? Today, in spite of ongoing research activities and several opportunities in place the current status of Indian CROs do not seem to be in sync. Elaborating on the present condition of the CROs in India, Nidhi Saxena, President & CEO, Karmic Lifesciences, avers, “The Indian CRO industry is currently going through turbulent times. While clinical trials from India still remains a huge potential opportunity, the business closures and materialisation of large scale deals have been slow. The industry is growing at a rate of 20-25 per cent and at a top line of approximately $ 1.0 billion still has less than 2 per cent of the global CRO industry.” She adds that it will take a few more years to get to an inflection point and start scaling. Also, the regulatory aspects need substantial reform and reconsideration by the policy makers to allow India to reach its true potential as a clinical research destination of choice. According to Saxena the market has two distinct segments, namely, Phase II-III clinical trials and the bio-analytical/bioequivalence market. For the former segment a few prominent Indian CRO names are Siro Clinpharm, Karmic Lifesciences, DiagnoSearch and Max Neeman, whereas for the latter companies like Veeda, Lambda, Ecron Accunova and GVK are well known. Further, global CROs
including Quintiles, PPD and Paraxel also have large bases in India. Researchers are of the opinion that the CROs in India are not in a stable condition. Dr R B Smarta, Founder & MD, Interlink Marketing Consultancy, explains, “When CROs came to India the entire situation was buoyant,
The regulatory aspects need substantial reform and reconsideration by the policy makers to allow India to reach its true potential as a clinical research destination of choice.
even Government of India had taken up clinical trials as one of the important initiatives. This is primarily because India clearly wanted to grow in this field. However, gradually, the focus shifted to China and that is where the major thrust went off.” However, why did it happen? Answering the question, Dr Smarta raises few other questions. He asks, “Do we attract clinical trials work from originators as they may have qualifying parameters?,” “Do we have the systems and the infrastructure that we need to have to perform clinical trials?,” “Do we have the backing of such policies that keeps the interest of all stakeholders?.” He says, “If
India does not lack either talent or opportunity. According to Dr Smarta, “Here is a country that offers excellent patient pool for all conditions, well educated research team, scientific pool along with governing regulatory!” He reiterates that what is needed is a strategy to take up this initiative with focus at public and private level in collaboration is the opportunity area. But what remains is the ambiguity, whether it is all positive for the CROs or is there a long way to go? Discussing the primary challenges in this regard, Saxena elaborates that the key challenges revolve around regulatory issues, data quality issues and funding/ scale up issues. On one hand, regulatory delays, ambiguity
We must remember that CROs are agencies working on outsourced work, so if the client base and funding is not adequate it is very difficult to operate. Dr R B Smarta Founder & Managing Director, Interlink Marketing Consultancy
and unpredictability followed by concerns over subject compensation issues have shaken up global as well as local sponsor confidence, and on the other hand, concerns over data quality and integrity are still not fully addressed. She highlights, “The investment community also has concerns about the industry scalability given that the boom that was predicted for the CRO industry never really concretised.” Seconding Saxena’s thoughts, Dr Smarta adds, “We must remember that CROs are agencies working on outsourced work, so if the client base and funding is not adequate it is very difficult to operate. We must remember the risk those funding agencies are carrying.”
Future ready To operate in such a challenging landscape, Indian CROs need to get creative in terms of business models and scale-up strategies. Commenting on the situation of Indian CROs, Saxena remarks, “For one, while India can serve as the operational backbone for data management, biostatistics and pharmacovigilance opportunities, Indian players need to globalise and look at US, Eastern Europe, Latin America and Far East as key locations for clinical trial execution so as to de-risk from India specific challenges.” There are several areas that might be advantageous for the CROs to function. Also, there is a huge potential for co-development and licensing opportunities with mid to small biotech companies especially into biologics and biosimilars apart from medical devices development. Dr Smarta says that if challenges are overcome, then we can surely have a different kind of scenario. While the industry still has huge potential, there are several short term impediments and Indian CROs will find it an uphill task to cross this chasm and get to real scale up.
Modern Pharma•16-31 Augus t 2012
Special Focus: Interface
With the desire to reach a global market, international CROs are now becoming an efficient and cost-effective option Arshia Khan email@example.com
What types of trends have you witnessed with respect to M&As and alliances in the clinical research space? Both M&As and alliances have become a trend in the Contract Research Organisation (CRO) industry. Many global and local CROs have merged or formed alliances with smallto medium-sized CROs to combine therapeutic expertise and enhance capabilities to allow them to better compete on a global scale. ICON continuously looks for suitable acquisitions or alliances that can either broaden the company’s service portfolio or add greater depth and scale to existing services. Asia Pacific is an increasingly important market and we plan to build our capabilities through acquisitions or alliances with key players in the region and a mixture of organic growth. What are the key drivers for the growth and development of the clinical research industry in Asia Pacific? We believe that the CRO industry will continue to grow in Asia Pacific and we have seen some new potential in the area of local pharma companies looking to expand both across the region and to the west; a CRO with global capabilities will be in demand. In particular, we have seen growth in Japanese pharma companies requesting to conduct clinical trials in other countries post the changes in new regulation. Previously, clinical trials for registration in Japan were only performed using patients in Japan. Within the last two to three years, due to changes in the regulatory environment, Japanese companies have become more
Pharma companies have started to form strategic partnership models with CROs with an expectation of moving Phase III clinical trials to Asia due to growing demand for multiple trials.
able and open to include ethnically similar patient populations in the region and they are increasingly including countries such as Korea, China and Taiwan in multinational studies to improve patient
recruitment times. Because Japanese pharma companies or local CROs do not generally have international experience, they are looking to use CROs with an established presence in the region having the added benefits of global expertise and experience. Similarly, Chinese companies with limited international experience are expanding their clinical trials activity outside the country are therefore using global CROs that have a presence in target countries. In the past, Chinese pharma companies tended to conduct the majority of their research within China, because local CROs provided a more cost competitive option. However, with the desire to reach a global market, international CROs are now becoming an efficient and cost-effective option. What are the growth pillars and prospects for the Indian clinical research industry? Significantly lower operating costs than those typical of western countries and the relatively easy availability of patient and gene pools have facilitated a range of trials in India. The growth of the sector has also been driven by good medical expertise, an English-speaking work force, advanced capabilities in technology and a modern hospital infrastructure. Its world-class laws on Intellectual Property Rights (IPR) have also boosted the industry confidence. India’s status as one of the first countries in the Asia-Pacific region to start a clinical trials registry (it is now mandatory to record all trials in the ‘Clinical Trials Registry - India’) has led to improved transparency and public accountability. Indian data is also accepted by the US FDA for drug approvals. Culturally, India has demonstrated strong doctor–patient relationships, with good treatment of and follow-up care for patients. Please describe in three phases the evolution of the global clinical research industry. Below are the changes and evolution of global clinical research industry: Phase 1: Pharma companies started to outsource contract services to CROs and most studies were predominantly conducted in North America, West Europe and Japan. The co-ordination between Europe, Japan and the US started a joint regulatory initiative on internal harmonisation in the beginning of 1980s. Currently, most clinical trial programmes follow International Conference on Harmonization (ICH) to ensure good quality, safe and effective
offshore research and drug discovery services to ICON in India? ICON India has successfully completed several inspections by the USFDA and EMA. It is also one of the few ISO certified CROs in India. We are committed to maintaining, supporting, checking and improving our quality systems to exceed the quality standards demanded by our clients, patients and regulatory authorities consistently. Besides that ICON’s combination of clinical and technological expertise helps clients find better ways to conduct clinical research and, ultimately, to rapidly bring safe and effective new therapeutics and medical devices into the global marketplace.
…underlines Denzil Benjamin, Senior Director - Clinical Trial Management, Asia Pacific, ICON Plc. Here, he shares details on the trends in the CRO industry and the influx of clinical trials in South East Asia. medicines are developed and registered in the most efficient and cost-effective manner. Phase 2: Pharma companies started to rely heavily on fullservice CROs in order to reduce the drug development costs and accelerate process time. However, the cost of conducting clinical research in North America and Western Europe is relatively high due to the difficulty
Sometimes the potential of South East Asia is overlooked due to the industry’s focus and fascination with North Asia (China, Korea, Taiwan and Japan). of patient recruitment and significant development costs, which caused pharma companies to look for solutions in emerging markets. Phase 3: The CRO industry is now considered a mature sector but Asia, East Europe or Latin America are still referred to as emerging markets. Pharma companies have started to form strategic partnership models with CROs with an expectation of moving Phase III clinical trials to Asia due to growing demand for multiple trials. Increasingly, CROs and pharma companies are relying on advanced technologies to increase trial efficiency and improve data management which is essential to support the key trends in the clinical development process.
Indian CROs are increasingly eyeing South East Asian countries such as Cambodia, Vietnam and Thailand, due to a responsive government and stringent regulatory environment. Which other countries are the most promising destinations when it comes to outsourcing of late stage clinical trials? Indian CROs are increasingly looking at other South East Asian markets to expand their operations due to the delay and uncertainty in approvals by the Indian government, and global sponsors tend to include other South East Asian countries to avoid delaying the study process. We do see increasing interest in South East Asia, particularly in those countries that are close to Singapore, which are mostly considered to be the natural hub for clinical trials in South East Asia. We have offices in Singapore, Thailand and now Philippines. We are monitoring Malaysia very closely and would expect increased operations in both Indonesia and Vietnam in the near future. Sometimes the potential of South East Asia is overlooked due to the industry’s focus and fascination with North Asia (China, Korea, Taiwan and Japan). But there is potential for large populations of treatment naive patients in South East Asia, even if the advantages are not the same as in North Asia. What are your strengths in terms of your ability to attract pharma companies to
Which of the services offered by ICON in India have shown an increase in demand and what could be the reason? The data management services have shown consistent growth in the last few years at ICON India. Our experience and understanding of Electronic Data Capture (EDC) processes and systems enables us to provide the optimum solution for each project. Our expert certified resource work with customers to ensure each trial is developed to the highest standards using the latest technologies available in the marketplace. What kind of global clinical research strategy has ICON adopted to stay one step ahead of the competition in the drugs research sector? We are building unparalleled informatics capabilities, which provide full transparency of trial data and enable better and faster decision making to increase process efficiencies and reduce costs. ICONIK, our integrated information platform, is being very well received by strategic clients. Our Firecrest site support technology and medical imaging solutions are also good examples of technology solutions. Through the acquisition of Oxford Outcomes and PriceSpective, ICON has created a market leading group in health economics, outcomes research, market access and pricing and value consultancy. These capabilities are set to become increasingly important for clients who need to demonstrate the economic value of new medicines and develop pricing and reimbursement strategies that maximise market penetration.
Modern Pharma•16-31 Augus t 2012
18 Special Focus: Roundtable
Does India follow a stringent regulatory process for approving clinical trials? Chandreyee Bhaumik firstname.lastname@example.org
Tapan J Ray
Shravanti Bhowmik General Manager- Clinical Research, Sun Pharma Advanced Research Company Ltd Since last year India has been following a stringent process for regulatory approvals. The positive aspects of this process are that there is a NDAC with a composition that is well suited to review a clinical trial, and ethical issues that may be more relevant and specific to a therapy area. This is a welcome step for clinical research in India and gives all stakeholders (participating subjects, investigators, CROs, sponsors) confidence that research in India is being conducted scientifically and ethically. It gives confidence to the general population and media that performing clinical trials in India is for the betterment of research required to bring drugs to the market; that majority of ultimate beneficiaries are from India, which given the high demographic dividend at present time, are going to be the population in most need of better therapies in future. The aspects that require immediate improvement are the approval timelines. The time taken for acceptance of a clinical trial application to NDAC review outcome has to be predictable and realistic. Cue can be taken from the timelines taken by regulatory agencies of countries with an evolved trial approval process. Further, there was a time when there were questions on scientific review of clinical trial applications in India. With NDAC, we have managed to close this question. The next major question is timeline; we hope this question is closed before clinical research comes to a standstill due to approval delays.
A New Drugs Advisory Committee (NDAC) was introduced to ensure a scientific environment and trials in India are conducted scientifically and ethically. However, in spite of all these efforts there is a huge need gap like the time for approving trials. Here’s the expert’s point of view on the rules and regulations in clinical trials.
Director General, Organisation of Pharmaceutical Producers of India (OPPI) Clinical trials are the core of researchbased pharma industry. No new drug can come into the market without clinical trials, which involve both potential benefits and risks to the participants. These are conducted with the primary aim of bringing to patients new medicines with a favourable benefit–risk ratio. The companies conducting research need to proactively publicise their commitment to protecting the rights, safety and well-being of trial participants. Additionally, all concerned must ensure that the proposals for clinical trials are approved by the government regulatory authorities before commencement and the trials must strictly follow the prescribed norms and procedures. The regulatory authorities, at the same time, should also ensure that any attempt of shortcuts or to bend the system by any means is met with severe consequences. There is an urgent need for the players in this field to reassure the public, in general, about the high ethical standards that the pharmaceutical companies and CROs require to comply with and continuously practice while conducting clinical research.
T S Jaishankar Chairman, Confederation of Indian Pharmaceutical Industry (CIPI) The Drug Controller General of India (DCGI) is taking enormous time in approving trials. No study can wait too long, thus leading to the trials going to other countries. India is doing only 1 per cent of the total trials in the world and even that will diminish. Reputation of India’s trial delays is well known globally. This issue is to be seriously addressed. While clinical trials can be recommended to New Drug Application Committee (NDAC), Bioavailability and Bioequivalence (BA/BE) studies should be cleared by DCGI himself as it is only for generics. In this regard, it can be said that if a BA/BE is cleared for one company the same may be cleared for all other applications subsequently for the same drug, without going through various layers of approval in the department. Further, the government must support monitoring or auditing trials randomly to bring in discipline among CROs. Currently there is no monitoring at all. One can say that if the department does not have adequate staff for monitoring, then they can assign to pharmacology department in government hospitals in the respective areas as is being done by National Accreditation Board for Testing and Calibration Laboratories (NABL) for accreditation.
Vikram Gupta Founder and Managing Partner, Ivy Cap Ventures Advisors Pvt Ltd There are challenges on both the sides. The regulatory process needs to be tightened up. It is still in the learning process. Further, whatever the policies have come, there is a need to follow up with that. In India, we are constantly following the international policies. Today, some of the regulations are right as they aim to protect the patients. However, what is important is the regular following up with the policies. We must remember that at present, the gap lies over here and this need to be catered to. To cite few examples, if one is dealing with oncology or diabetes or any specific therapeutic area then it is seen that the regulations are not as stringent as they should be. The regulations are all broad enough. There is less clarity in this regard. This needs to be more organised. Today, the CROs are finding it difficult to grow up to the next level. They want to acquire the companies abroad. The primary reason for this is that the big pharma prefers multi-geographic locations along with visibility. With time, the Indian CROs are realising that there is a need to be elsewhere and thus they are looking for active acquisitions. And it is important to remember though from the valuation point of view that these acquisitions might work out but it will not be easy in terms of other factors.
Editorial take A strict regulation system forms a vigilant foundation for any system and clinical trials are no exception There is a definite need in this regard to tighten the regulatory system such that there is desired efficiency in the way trials are approved and conducted. But, along with efficient regulatory system in place, we also need quick approvals from the DCGI. Steps have to be taken to tackle the timeline problems, since due to these, certain international companies are planning to shift their outsourcing destination.
Modern Pharma•16-31 Augus t 2012
Piramal Pharma Solutions, Ahmedabad
Keeping pace with changing trends Shibani Shah email@example.com
harmez, the Special Economic Zone (SEZ) in Ahmedabad houses some of the most reputed pharmaceutical companies in India. To cash on the Gujarat’s policy of promoting industrial development and gaining tax benefits, many multinationals have set up their units in Gujarat. In order to gain benefit of this situation, the pharma giant Piramal Healthcare has set up its research centre Piramal Pharma Solutions (PPS) in Pharmez to carry out its outsourcing activities for development of early stage formulation dosages. The Pharma Solutions division of Piramal is spread across India, China, UK and Canada. It mainly deals with API development and manufacturing, formulations development, drug discovery services and commercial formulation manufacturing. The Ahmedabad-based R&D centre houses the drug discovery activities, formulations development and clinical trial manufacturing and is an ISO-14001 & OHSAS18001 certified site.
Piramal Pharma Solutions, a division of Piramal Healthcare, has a wide global footprint. We take a look into its R&D centre and pilot plant site located at Ahmedabad, its establishment, infrastructure and future plans.
Seeds of establishment Established in 2009, the R&D facility is spread across
educational degrees in MSc or MPharm. Besides, there are qualified teams in pilot plant and quality control.”
Concern for the environment Energy efficiency is important considering the global energy scenario. The site is installed with variable frequency driver that matches the energy consumption with the load. Effluent and waste treatment is carried out within the premises of the facility. The solid, microbial and domestic waste is segregated and treated before being released into the environment. The smoke that is released into the atmosphere is checked for its content and its toxicity with the help of smoke detection systems.
Changes in the market
50,000 square feet, Vijay Shah, Executive Director & COO, Piramal Healthcare Ltd, informs, “The vision of the site has been to provide scientific development and GMP facility for clinical trial manufacturing of solid oral dosage formulations for new chemical entities for discoveries led by large pharmaceutical companies.” The drug discovery division of PPS was started in January 2011. The research site supports pharmaceutical companies from US, Europe and Japan. Shah adds, “Over
Microbiological lab for environmental monitoring
the years, the site has been working closely with 5 of the top 20 pharmaceutical companies of the world. Besides, the expertise has been extended to the mid-size and virtual companies for enabling their pipeline of molecules by developing formulations for Phase 1-3.”
Infrastructure The centre is packed with analytical labs, labs for conducting stability studies, pilot plant and warehouse spread across a well planned layout. The R&D centre not only has measures for safety exit during an emergency situation, but it has also gone ahead to train a group of its employees to handle emergency situations. It is commendable to see stringent GMP practices being followed at every step. There is a separate entry for the raw materials to enter the lab where it is thoroughly checked for quality and stored in segregated zones at their in-house warehouse. It also has separate fume hoods to handle hazardous chemicals. The facility houses machines for manufacturing of products of different batch sizes. The facility deals with manufacturing of both lab scale and pilot scale production; manufacture batches range from 50 g – 40 kg. Technology transfer is one of the key parameter in contract manufacturing. The state-of-the-art machinery helps PPS fulfill this criterion as well. The site is well equipped to handle potent molecules with Occupational Exposure Limit (OEL) above 1 mcg/ m3. To handle these highly
potent molecules there are specialised processing suits to maintain the health of the handlers. It can also handle low RH compounds and nonaqueous solvents. The site is well regulated at each step. There is a special monitoring system to check temperature, humidity, and differential pressure and sends a signal via SMS and alarms in case of any deviation in the set condition. The biggest strength of any manufacturing lies in the expertise and manpower. Shah elaborates on the manpower and says, “We have formulations research scientists with Masters and PhD degrees in Pharmacy from reputed Indian and foreign universities. To support analytical development services, the company hires the best of talent having
The future plans include expansion of current pilot plant and formulation labs capacities for oral solid dosage formulations. Vijay Shah Executive Director & COO
There are dynamic changes being observed in the industry of late. This trend is likely to continue with more than $ 9 billion drugs going off patent by 2015. The existing market is based on the development of generics in various simple and complex dosage forms. Shah elaborates, “The site has also grown to offer research-based solutions for the development of line-extension dosage formulations such as fixed dose combinations for large pharmaceutical companies based out of UK/USA and Japan.” Biosimilars is also seen as an emerging market. Piramal expands its expertise in this field with the development of non-infringing generics, “The site services offer formulation development expertise to development of patent non-infringing Para-3 generics for clients from Europe and US while respecting the patents of the innovator companies.”
Future plans and growth strategies From solid dosage formulations the company plans to expand to liquid dosages as well. Shah explains the future plans, “We have appetite to grow from here based on the business environment. The future plans include expansion of current pilot plant and formulation labs capacities for oral solid dosage formulations. Besides, we are also evaluating to build liquid dosage formulations capabilities at site and other expert areas, such as inhalations and paediatrics.” PPS believes that their quality and Environmental, Health and Safety (EHS) practices act as a door opener for their clients. The intricate details that have been taken care in the planning of facility and the manufacturing practices will make us agree to it.
Modern Pharma•16-31 Augus t 2012
20 Insight & Outlook: Policies & Regulations Clinical Trial Registry (CTR) is an official platform for registering a Clinical Trial (CT) with an objective of providing increased transparency and access to CTs to the public at large. Governments of different countries and international organisations have been making efforts to make CT information more widely available to the public. Countries which have CTR include Australia, Brazil, Canada, China, Cuba, Europe, Germany, India, Iran, Italy, Japan, South Africa, South Korea, Sri Lanka, United States, Netherlands and New Zealand.
Clinical Trials Registry - India
The system in place Clinical Trials Registry India (CTRI), hosted at Indian Council of Medical Research’s (ICMR’s) National Institute of Medical Statistics (NIMS), is a free online public record system for registration of CTs being conducted in India. CTRI was established in October 2005 and was officially launched on July 20, 2007. However, at that point in time, registration was on a voluntary basis. Since June 15, 2009, CT registration in the CTRI has been made mandatory, by the Drugs Controller General of India (DCGI), before enrollment of the first subject.
Positives There are several positives of the CTRI. First of all, registration is free of charge to anybody with Internet access, thereby encouraging the sponsors or their designated surrogates, collectively known as ‘data providers’, to register their trials. Once registered, all updates and changes get recorded and are viewable in the public domain. Second, given that CTRI has additional items and
fields over and above the 20 items in the World Health Organization (WHO) trial registration data sets, such as phase of trial, study sites, names of ethics committees and approval status, estimated duration, method of generating randomisation sequence, blinding, masking, estimated trial duration and brief summary, it would influence and strengthen the study design, conduct and eventual reporting of CTs.
Third, once registered in the CTRI, the WHO trial registration data sets are transferred to the central repository of the WHO’s international CTR platform (ICTRP) search portal. This gives the trials greater visibility as the details will be searchable through the WHO ICTRP search portal. The trial results will qualify to be considered for publication in journals that endorse the International Committee of Medical Journal Editors’ (ICMJE) position on prospective trials registration. Fourth, CTRI helps provide a base template for designing the study protocol and also leaves scope for raising the standard of study design and trial. It also helps expedite the overall study duration, as there is a ready database of trials done in a similar setting, indication and investigators that can be capitalised upon. Finally, CTRI helps informed decisions, for healthcare providers, policy makers and funding agencies, Ethics Committees (EC), journal editors and market researchers.
cross verify against all the elements entered. Limited verifications are performed by sending system generated mails to investigators and contact persons. Compliance checks are not performed for the study protocol to verify if the ‘data providers’ are providing the correct, abridged or complete information. Further, once a CT is registered, the ‘data providers’ are expected to regularly update the trial status or other aspects as the case may be. However, this does not happen in many cases. There are also no hyperlinking to relevant documents and information in other online biomedical resources, such as Pubmed and Medline, to access related health topics. CTRI is an important initiative that has been taken by drug regulators and is relevant in the context of increasing number of clinical trials and an ethos of transparency. With improvements, CTRI could well become an important and authoritative platform for information sharing and transparency in clinical trials, and, in the process, enhances India’s position in the clinical development domain.
Flip side On the flip side, CTRI does not ensure that all trials will be registered. Many investigator driven trials still go unregistered. Also, as part of quality control checks, the CTRI does not
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Should India pay
Shasun Ph arma facility in APto start intermediates , hire 100 people
Healt SHASUN renamed post hcare to be Pharmaceutic diversifi Ltd is all PHAR MA set to establis als major Pirama cation facility at Naidup h a will be l Healthcare capacity of eta, Andhr renam ed Pradesh. And a 12,000 tonne as Piram Enterprises hence, consta intermediates al of following efforts are Kumar added nt . Elaborating entry into its recent being made in this that the diversified company decreasing regard , Kuma activities. is planni business dependence at highlights, The rechris Chinese on “This facilityr recruit 100 peopleng to tening comes four years imports will be primar after for its . He remarked, business. The became Piram Nicholas Piram “We are lookin company is two object ily serving at al of the largest one g chemi appropriately al Healthcare. “To manufacturer there wouldives. First, chemic stry graduates or reflect the of s pain al engine changed company’s be nondepen dence business with us.” Setting ers to work drug Ibupro manag ement profile, it proposed on fen. China is for supply up a facility is that the Kumar not an easy Accor ding and second name of company job to be done. would be the to Abhay be it Talkin Kuma r, assurance g Enterprises changed to Piram on about MD, a the hurdle timely 50-acr e of he reitera al Shasu n Ltd,” Ajay Pharmaceuti s, availa bility land in Chairman, Naidu peta, tes, “Techn cals Ltd, products.” of remain Piramal Health Piramal, ology is expect facility, under the to He further s at the annual still care, stated ed a start challen added that the construction operat ions ge. We general meetin have to find total investm March 2013 by would g. cost effectiv ent ways with an annua be e in order Zydus Urosc l `100 crore. approximately iences launc with the Chines to compete Udenafil hes e prices.” ZYDUS Urosci - Chandrey ee Bhaumik ences, the STRID ES division of specialty Zydus Cadila announced Arcol ab Ltd has Udenafil a has that Propar next gen therap launched company Development co, a French with the philoso treatment y for the of Africa for phy of ’In has investe Financing Institution, Africa’. (ED). Udena Erectile Dysfunction most d $ attract 12.50 fil, a newly Stride ive million in form of equity potent and of tomorrow business opportunity the Africa s has been presen selective PDE5developed, participation 20 per cent and this t in with approved for for a impro and contri buting inhibitor partne stake in Strides Proparco the treatm to the vemen t front-end further streng rship ent of ED, ’ African been launch of health our comm arm, valuin has ed manuf acturi thens care by itmen t to g the Africa operations Udzire. The under the brand name ng and quality and at about $ n wide provid ing marke ting group has range of 60 million timely medic The procee license to a Africa an . ation ns. Creati lifesty le diseaslifesaving antibiotics, market this exclusive create additi ds will be used on of additi to molecule patented e related manuf acturi to and developed onal curati ng infrast nutrit ion/ infrast ructur onal manu factur Pharmaceutic by ructur e will ing formu relief provid ves also provid e in key als of Korea, Dong-A e large lation s. Sinhu Africa and marke ts in ing oppor in India. emplo yment to build e tunitie CEO, Noron s and econom Africa ha – to a region al all associa ic growth Arcolab Ltd, Opera tions, Stride ted with s Africa said, “Afric the Strides n Business a is the ’ and reinfo belief that rces our life is most precious”
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The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80,000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,
tax air tickets
Ideal cures develop Inst am system for ER formulat odel ions
uces OneLa for AIDS drugs AS health as care system b proposed by the world the UN? s face challen around as labour ges such shorta ges, regulation increa sed and budge t constraints, they rely on techno logy to help manage the impac t. To assist in addres sing these IDEA L Cures Abbott annou challenges, has develo extended ped an Web-based, nced OneLab, a new, deliver y system Instamodel informatics integrated laboratory named that allows solution. of any drug the release OneLa highly-confi on specialised for a longer gurable platfor b is a time with excipients period of allows labs m that continuous value to that will add of any size the produc medication availability to processes ts and facilita the manuf of to patient across multip standardise acturin thereby cuts or user, and te and autom le locations product quality g and enhance ate such doses the frequency at which the such as sampleroutine procedures and attribu have to be the future tes. On Suresh Pareek plans Pareek management administered tracking, as “We have . and well as test “Instamodel , MD, Ideal Cures very ambiti commented and approv result review said, future ous plans will be targeting al. and would sized pharm the midlike to grow for a double digits have proper companies who do in (about 30 Taro Board not percen per infrast cent) of tage on rejects Sun ructure for development offer for comp Pharma the science and yearly basis. Ours will and have the Extend still they would like research based be TARO Pharm lete acquisition and to organi ed our Release sation approach aceutical products in (ER) range board has will be to Industries’ the innovative of rejected an bring out produc can also use market. Other custom offer Pharmaceutic ers pharma indust ts to support growin our expert al Industries from Sun technical suppor g systems and ry.” its issued to purchase Elaborating t to reduce and outstan expenses for not held by ding shares development the time and and its future on its business in India the the simple . These will due to inadeq Indian pharma firm st of be Pareek added, expanding strateg Pareek uate price. allow the conventhe solutions that ies, “Our major Committee will “Special of now is of Board up to produc tional or prevailing in India and business as unanimously of set many to 90 per e specialised the revenu rejected the Directors products at cent extent more are e 2011 unsolic October 18, on the anvil. no extra cost.” high quality the by domes is contributed ited, non-bi work tic Besides Pareek added, on from Sun business develo business only. Pharmaceutic nding offer “The project compounds neutral spheres, cooling The Instamodel s on the and some to purcha al Industries for ER tablets major objecti pment globally is new se all of compo film our have sition formul ve and in the issued come up with outstanding is under progre coating we would and several produc ations shares of While film ss.” like to see next 5 years currently ts and busine coating is 25 -30 per approximatel held by Sun Taro not cent its core ss Ideal cures y $ 24.50 per by off shore revenue being genera also plans share as inadeq Pharma for ted to focus supplies.” in the best uate and not interests of Taro’s minori shareholders, - Shibani ty ” Shah Pharmaceutic a statement on Taro al’s website stated.
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Modern Pharma•16-31 Augus t 2012
Green logistics Shibani Shah firstname.lastname@example.org
ransportation of temperature-sensitive products is associated with stringent regulations. The supply chain extends from a raw material being transported to the production center and distribution of finished goods to the point of consumption. The logistical activities comprise freight transport, storage, inventory management, materials handling and all the related information processing. With companies extending their supply activities to Logistics Service Providers (LSP) in order to save costs, LSP uses the best of technology to meet the products transportation needs. Refrigerators are used on a large scale in order to maintain the temperature of these products. This process consumes a high amount of energy leaving behind a deep carbon footprint on the environment. Energy management or ‘Green Logistics’ as they call it appears to be the need of the hour with the growing adversity of the environment situation.
Cost effective: A or
With the rise in trade of pharmaceuticals/drugs there has been a steady increase in the emission of carbon footprint. In 2010, 1,696 million metric tons of carbon dioxide was emitted by consumption of energy in India alone says study conducted by Craig Bloodworth of the Information Lab. A report predicts this to increase from 7 to 14 per cent by 2025. Strategies, solutions and services in the supply chain can be effective.
‘Going green’ will reduce the cost? The debate if going green would reduce cost has brought to light that while greener alternatives reduce the bills of the LSP, they tremendously increase the initial investment cost. The LSP’s are hired by the companies for a short period, which is also why the LSP’s hesitate from investing. Sugato Chandra, Principal Advisor, Crosstree Technovisors, further explains, “The situation in Europe
In India, the service provider gets a maximum 1 year contract for handling the logistics of a particular drug or any pharmaceuticals product. Sugato Chandra Principal Advisor, Crosstree Techno-visors
and India is very different. There has been an evolution in the investment trend in the country but still it has a long way to go. In India, the service provider gets a maximum 1 year contract for handling the logistics of a particular drug or any pharmaceuticals product. So it is not viable for them to invest a huge capital in a technology that would otherwise be lying unused. Therefore, the LSPs shy from investing as it becomes is difficult for them to recover the cost. What could work in the country is LSP as a partner, which does not exist in India.”
The missing links While some believe that it is entirely the duty of the LSP to check the carbon footprint. Chandra believes that it is the responsibility of each participant in the supply chain to take measures. Chandra adds, “LSP’s play a vital role in energy
management. But to expect the LSP to do miracle is not possible. No one exists alone. The manufacturer, LSP, consumers all will have to work together to bring a change.” Companies if work in close co-ordination with the LSP it will help both of them to arise with an intermediate solution to come up with greener solutions for the benefit of all.
Alternatives, solutions, strategies The green cycle concept can be executed efficiently with sustainability at every level. Globally, transport contributes 10 per cent to the total carbon dioxide emission. In India transportation contributes up to 7 per cent in the carbon emission which is expected to rise to 14 per cent by 2025 according to studies. For longer distances in domestic logistics, experts suggest rail over road. This will not only reduce
the cost but also rail transport hampers the environment lesser than road travel. In the international scenario, shipping has a deeper
Innovative packing solutions can also be helpful to reduce the energy required to maintain the desired environment for transportation of the product. impact on the environment as compared to air transport. A smart solution to this problem can be the smart use of equipment. A well planned use of equipment will help reduce the energy consumption greatly. Energy management also includes the high consumption of fuels that are involved in the logistics practices. At certain cold storage units, rice husk
is used as an alternative to diesel. Bio-fuels and bio-gas are innovations that can be further explored as an alternative. MNC’s and Indian logistics companies are greatly using battery operated fork lifters for in-house transport. Innovative packing solutions can also be helpful to reduce the energy required to maintain the desired environment for transportation of the product. DHL, Damco and other logistics providers undertake secondary packaging to ensure quality of the product. Materials are being developed that can maintain the optimum temperature for the product without refrigeration. Lighter weight designs can be used to reduce the drivers size that will translate into lower energy consumption hence ideal power management is essential. 3PL is the expert’s suggestion to reduce cost. While the cost and technology gets shared, the amount of carbon emission also gets shared in the 3PL strategy. But when dealing with pharma products, the high standards do not give the flexibility to store different kinds of products together. Eventually, to maintain these small volumes in efficient condition, the energy consumed and the carbon impact will be more. Efficient utilisation of the capacity is also important. Tailor-made logistics solutions instead of conventional ones can ensure energy safety throughout the process. Also, regular preventive maintenance helps the logistics companies to maintain energy efficiency and upgrade to greener solutions. Further, LSP’s have developed tools in order to forecast the carbon footprint each consignment leaves and determining the cost of the shipment accordingly. Thus, the manufacturers and LSP’s can strategise the whole process to minimise the carbon footprint. Damco, DHL, TNT are some of the MNCs that provide green logistics solutions and tools. Logistics is as important as manufacturing. Ultimately if the final product does not reach the consumer in the consumable state then all efforts are in vain. Although we can curb the carbon emission to a certain extent, it is not completely avoidable. We all co-exist in the environment. and for a greener and healthier world each one of us needs to play our part. A little change in our own sphere with our little efforts can bring about a big difference.
Modern Pharma•16-31 Augus t 2012
Insight & Outlook: Interface
The key logistics issues are push-based supply to depots, stockists and retailers Chandreyee Bhaumik email@example.com
What are the recent developments as far as logistics of pharma is concerned? The pharma industry has grown well at over 10 per cent in the last few years, and is expected to maintain the growth rate for the next few years too. Pharma logistics is one of the most important stages of the operations for any pharma business. Since pharma products are sensitive to external environmental factors such as heat, light etc, any sort of deficiency in the pharma transport/storage system could damage them. So starting from collection to delivery/distribution of pharma products, logistics service providers need to arrange for maximum safety of the consignment. Infrastructures like India’s first pharma dedicated zone at Hyderabad airport, advanced multi-chambered cold chain warehousing zones and IT device integrated vehicles are some of the most significant developments in pharma logistics. What are the important considerations for pharma Supply Chain Management (SCM)? Indian pharma industry is mounting up the value chain. From being a pure reverse engineering industry focussed on the domestic market, the industry is moving towards basic research-driven, export-oriented global presence,
providing wide range of value-added quality products and services. The important considerations for pharma SCM are: Lack of adequate infrastructure and temperature-controlled equipment and facilities Poor packaging To maintain delivery schedules and meet deadlines For this, a strong cold chain network is required. As international and domestic firms are increasing their presence with new pharma products having new characteristics, they have started raising the bar for Logistics Service Providers (LSPs). Practices such as handling products without touching them and temperature monitoring are becoming common. In-house training on to product handling and training centres are also being set up to educate the front level people who handle these products. What are the steps taken by TCI to upgrade cold chain? The TCI supply chain division is mainly focussing on the cold chain as a vertical since India is evolving rapidly and it is the interplay of infrastructure, technology and new types of services Today, TCI has taken various steps to develop and upgrade cold chains such as: Fully customised services as per the customer need Imported units with digital data logger GPS tracking with central control room
…says Rajkiran Kanagala, Head - Business Development, TCI. Here, he discusses issues in pharma SCM and how TCI plans to tap the varied opportunities. Temperature range from -25 to +25 with +/-0.5 Project movement during harvesting season What are the key logistic issues in the pharma industry? How do you plan to overcome them? The key logistics issues are pushbased supply to depots, stockists and retailers; mis alignment between sales and supply chain organisation on
timing (start and end) of promotions; lack of visibility on products nearing expiry, inefficient warehousing processes related to storage; handling and retrieval; quality of the cold chain infrastructure – substandard local equipments and break in continuity of the chain due to several intermediaries; high cost of logistics – for part load transportation, manufacturers have to use the conventional methods of thermocol boxes with ice packs and gel packs. To avoid this problem TCI offers state-of-the-art vehicles with imported refer units for temperature-controlled pharma products. The vehicles are equipped with GPS base tracking system and temperature data loggers to log the temperature throughout the journey. Distribution system in relation to pharmaceuticals is been organised and brought under a proper domain ‘cold chain’ Multi-functional warehouse with temperature control Multi-chambered warehouse Proper infrastructure better cold chain vehicles is essential for the proper transportation and storage of the drugs WMS & inventory management for providing product integrity, and thus ensuring patient safety Careful climate control throughout the transit period Ensure fully integrated upgraded software such as track & trace system, bar coding/RFID to monitor the total visibility of the position of the product.
Modern Pharmaâ€˘16-31 Augus t 2012
Tips & Tricks
Ways to choose the right one linical trial programmes are a high criticality activity for pharmaceutical and biotech companies. Hence, choosing the appropriate CRO partner is highly imperative. With so many CROs to choose from and so many factors to consider, it can be an extremely circuitous task picking the best fitting CRO for your trial requirements and more so to ensure that the CRO delivers. Here are some tips that can serve as a checklist to help ease the process and ensure all critical parameters are covered during the CRO selection process. The selection parameters have been divided into three broad heads.
Nidhi Saxena Founder, President & CEO, Karmic Lifesciences
Global presence and regulatory expertise Most of the studies, especially late phase studies are multinational, spread across different geographies. Global presence of a CRO plays an important factor in deciding outsourcing of clinical studies. Companies are now looking at emerging markets such as Eastern Europe, LATAM, APAC to locate studies. Owing to the recent trend of association between pharmaceutical companies and CROs for more than one study, even if a study is not multinational, pharmaceutical companies prefer to partner with a global CRO considering possibility of studies in pipeline with multinational requirements. Further, regulatory expertise across multiple regulatory regimes including US-FDA, EMA, PMDA, Health Canada, TGA, HSA etc, is extremely critical.
CRO track record and relevant experience Robust execution track record in various trial phases including Phase I-IV as well as experience across a broad set of therapeutic areas including oncology, CVS, diabetes, neurology, etc, can be an important consideration in selecting a CRO. Further, niche experience in areas such as biosimilars, medical devices, post marketing surveillance, etc contributes significantly towards making decisions on outsourcing. Finally, experience in conducting studies across a range of subject numbers from 12-20 subjects to large Phase III and Phase IV programmes with several hundred and thousand subjects helps select the right CRO for a broad range of requirements.
Prolific end-to-end services portfolio Current trend is shifting towards â€˜One Stop Shopâ€™, wherein CROs with end-to-end service provision capabilities are preferred. CROs which can cater to different requirements of a programme, such as medical writing, data management, bio-statistics, pharmacovigilance, regulatory submissions and even co-development and licensing support over and above clinical operations are preferred.
CRO general parameters
CRO advanced due diligence parameters
Creative execution models and commercial flexibility The CRO business is no longer a vanilla business model but involves various programme models such as outsourcing, insourcing, Full-Time Employment (FTE)-based model, project-based models, risk sharing and co-development models etc. A CRO offering multiple creative models helps a client have greater flexibility to pick and choose the best-fit model for programme needs. More importantly commercial flexibility in terms of offering creative and flexible engagement and payment terms helps sponsors de-risk and compensate only on achievement and mutually agreed tangible milestones including regulatory approvals, subject recruitment completion, database lock, etc.
CRO operational capabilities
Scientific/Medical and statistical expertise Good clinical programmes get executed on the basis of sound scientific rationale and study design and it is here that the scientific/medical knowledge and statistical expertise of a CRO are extremely critical parameters. The scientific/medical team composition and experience, papers and articles published, statistical tools and techniques applied, samples of prior work done in a given therapeutic area/phase are parameters to review.
Operational expertise A qualified and experienced delivery team ultimately makes that crucial difference between a successful and a failed programme. The individual and aggregated experience of the team bottoms up from the clinical research associates and clinical trial administrators level to project managers, line managers, data management staff, etc needs to be evaluated in great detail.
CRO operational, data and quality assurance policies and procedures CRO is a heavily regulated and procedure oriented industry hence the availability of high quality, structured and in-depth SOPs, templates, quality manuals, work instructions, training manuals, etc is extremely important. All SOPs, data confidentiality, quality and training records need to be audited on a sampling basis before finalising a contract. A physical CRO facility audit is highly recommended prior to final contract award.
Sponsor reference checks Pharmaceutical organisations extensively value client referral checks at final stages of CRO selection. Referral of renowned and R&D driven organisations is considered valuable and can be deciding factor in finalisation of CRO selection during final stages. Another factor to be considered while providing referral checks would be similarity between programmes. Referral from a medical device organisation would be more valid for another medical device organisation.
Financial stability and due diligence While many sponsors spend a lot of time in operational due diligence, financial due diligence of a vendor is equally important. Clinical development programs are typically long term programs and a CROs financial stability and legal standing should be the final holy grail for awarding the contract.
Modern Pharma•16-31 Augus t 2012
Projects 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. Conservation, cultivation, and sustainable utilisation of medicinal plants Project type: Conservation & cultivation of plant Project news: Himalayan herbal doctor ‘Amchi’ have been contributing significantly to the health care system of remote mountain communities in the Himalaya region. In many parts of Nepal. amchi are the sole providers of health care. However, despite the great benefit that comes from amchi, medicine, this system is under threat in Nepal. The project aims for conservation, cultivation and sustainable utilisation of medicinal plants, support amchi clinical and educational institutions and promote networking and
collaboration for marketing and income generation. Project location: Nepal Project cost: $ 4,96,100 Implementation stage: Ongoing
release of nanomaterials /drugs. Project location: India Project cost: ` 35 lakh Implementation stage: Ongoing Contact details: Defence Institute Of Advanced Technology, (Deemed University) Girinagar, Pune 411025, India Attn : Dr Sangeeta Kale Tel : 020-24304021 Fax : 020-24389318, 24389411 Email : firstname.lastname@example.org
Contact details: Sgp Nepal PO Box 107, Kathmandu, Nepal Tel: (977-1) 5000 119 Fax: (977-1) 5530 269 E-mail : email@example.com
Drugs for neglected diseases Project type: Initiative for new modalities Project news: The Project of Drugs for Neglected Diseases initiative is to establish and implement new treatment modalities as successful tools to control and support the elimination of Visceral Leishmaniasis in the most endemic regions of South Asia.
Cross-linked polymeric cages Project type: Drug R&D Project news: Cross-linked polymeric cages for encapsulation and sustained
Project location: USA Project cost: $ 9,000,000 Implementation stage: Ongoing
Contact details: Bill And Melinda Gates Foundation PO Box 23350 Seattle, WA 98102 USA Tel : (206) 709-3100 Pharma project Project type: Fight to combat ART Project news: Kenya has been hit hard by the HIV/AIDS epidemic. The Government of Kenya has addressed the challenge head on, declaring a ‘total war’ against HIV/AIDS, with a stated goal of achieving universal access to Anti-Retroviral Therapy (ART) by 2010. The pharma project is working in collaboration with the Kenyan Government to achieve this goal by establishing a reliable and sustainable pharmaceutical supply chain management system that improves forecasting and planning commodity procurement needs, reduces costs, increases local resources for quality assurance, and conquers ‘last mile’ logistics to ensure that supplies reach remote areas. Project location: Kenya Project cost: NA
Implementation stage: Ongoing Contact details: Chemonics 1717 H Street, NW Washington, D.C. 20006 USA Tel: 202.955.3300 Fax: 202.955.3400 Royal University Hospital Pharmacy Project type: New facility Project news: Saskatoon Health Region is planning to build a new pharmacy facility. It will be known as Royal University Hospital Pharmacy. Project location: Canada Project cost: $ 6 million Implementation stage: Ongoing Contact details: Saskatoon Health Region Corporate Office Level 1 Administration Saskatoon City Hospital 701 Queen Street Saskatoon SK S7K 0M7 Tel : (306) 655-7500 Website: www. saskatoonhealthregion.ca
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: firstname.lastname@example.org
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Modern Pharma•16-31 Augus t 2012
N AT I O N A L E V E N T S Annual Pharmacovigilance 2012 The event aims to discuss the latest technologies, methodologies and introducing pharmacy automations on work practices of pharmacovigilance, recent successful strategies and business models to bring out new medicines, keeping abreast of the changes impacting the drug safety industry, etc. Further, there will be discussion on global marketing strategies; August 31, 2012, Hyatt Regency Mumbai For details contact: Virtue Insight Tel: +91 44 64536444 Fax: +91 44 64536443 Email: firstname.lastname@example.org Website: www.virtueinsight.com
Automation 2012 All leading companies in industry will showcase their latest products and help one find the solutions at the show. The show brings latest technologies from an interesting array of fields such as: factory automation, process automation and control systems, robotics & drives, field instrumentation & smart sensors bus technologies, software solutions, wireless technology, building automation, and hydraulic & pneumatic automation in renewable energy. From technocrats to solution providers, vendors and tech-buffs, the fair is all set to draw every one alike; September 7-10, 2012, NSE Complex, Mumbai For details contact: IED Communications Pvt Ltd
Tel: +91 22 22079567 Fax: +91 22 22074516 Email: arokiaswamy@ iedcommunications.com Website: www.iedcommunications.com
Pharmac India It is a-three-day event that aims towards highlighting several issues of the industry. This will be large hub of reputed professionals from pharma formulation, herbal products, veterinary drug, medical & disposal, pharma machinery and many other sectors. There will be visitors from pharma company marketing/purchase/ export executive, marketing company & consultant, merchant exporters, contract manufacturers, pharma distributors, generic & OTC manufacturer & wholesalers, Government supplier, liaison agents, sourcing companies, production & purchase professionals, and international business representatives; September 8-10, 2012, Gujarat University Exhibition Hall, Ahmedabad. For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91-22-24102801 Fax: +91-22- 24102805 Email: email@example.com Website: www.orbitzexhibitions.com
Indian Pharma Expo 2012 Indian Pharma Expo 2012 is the perfect solution to meet the needs of the rapidly growing Indian pharma industry; to be able to network under one roof. There will be discussions on regulatory issues affecting the pharma market, commercial strategies and business models of key
Gujarat, Oct 5-8, 2012
Maharashtra, Nov 2-5, 2012
Tamil Nadu, Nov 22-25, 2012
Punjab, Dec 21-24, 2012
Madhya Pradesh, Jan 11-14, 2013
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.
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players, maximising revenue, overcoming challenges and achieving growth and revaluating possible development scenarios. Further, there will also be discussions on effective marketing strategies; September 22-23, 2012, Pragati Maidan, New Delhi For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: email@example.com Website: www.ubmindia.in
2nd Pharma Supply Chain Forum Now in its 2nd year, Pharma Supply Chain Forum is India’s premier pharma supply chain and logistics event in India covering a comprehensive range of supply chain topics including network optimisation, lean management, inventory management, security management, cold chain management, supplier-partner relationship management, packaging technology, forecasting & sourcing, and pedigree compliance; September 27, 2012, Taj Lands End, Mumbai
For details contact: Kamikaze B2B Media Tel: +91 22 613 81800 Email: firstname.lastname@example.org Website: /www.elscconclave.com/ pharma.html
Indian Lab Automation conference and exhibition ILA 2012 will feature three technical conference tracks; ‘Drug Discovery and Development’, ‘Advances in Bioanalysis’ and ‘Advances in Genomics and Informatics.’ Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai For details contact: Select Biosciences Ltd Tel: +44 1787 315110 Fax: +44 1787 315111 Email: email@example.com Website: www.selectbiosciences.com
I N T E R N AT I O N A L E V E N T S JCBBB 2012 The 3rd Journal Conference on Bioscience, Biochemistry and Bioinformatics (JCBBB 2012) aims to provide a forum for researchers, practitioners, and professionals from the industry, academia and government to discourse on research and development, professional practice in bioscience, biochemistry and bioinformatics. This is one of the leading international conferences for presenting novel and fundamental advances in the fields of bioscience, biochemistry and bioinformatics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving bioscience, biochemistry and bioinformatics related techniques; September 1-2, 2012, Phuket, Thailand For details contact: International Journal of Bioscience, Biochemistry and Bioinformatics Tel: +91 422 2611146 Fax: +91 422 2611043 Email: firstname.lastname@example.org Website: www.ijbbb.org
International Symposium on Pharmaceutical Reference Standards The event aims to discuss current topics and future approaches related to pharma reference standards. Pharmaceutical reference standards are essential for the quality control of
medicines. The symposium will bring together stakeholders involved in the production, characterisation and use of reference standards to exchange their views and opinions on the different issues related to the subject; September 3-4, 2012, EDQM Premises, Strasbourg, France For details contact: EDQM Public Relations Division & Documentation Tel: +33 0 3 88 41 31 50 Fax: +33 0 3 88 41 27 71 Email: email@example.com Website: www.edqm.eu
NCCR 2012 The 6th National Conference for Clinical Research 2012 (NCCR 2012) aims to serve as a platform that aims to bring together clinical investigators, industry professionals, regulatory agencies and policy makers in order to address the issues and challenges of the industry. By gathering people from various research disciplines, the event aims to foster constructive and forward looking discussions, sharing of experiences, and mutual commitment towards the betterment of humanity; September 23-25, 2012, Sunway Pyramid Convention Centre, Malaysia For details contact: Association of Clinical Registries, Malaysia (ACRM) Tel: +603 4044 3060 Fax: +603 4044 3080 Email: firstname.lastname@example.org Website: www.nccrconference.com
CSBio 2012 CSBio 2012 will also cover the engineering sciences related to the pharmaceutical industry, in both material and manufacturing sciences. This conference would like to gather like minded researchers and industrial counterparts who are involved in designing, developing and improving industrial processes and equipment for large-scale chemical and pharma manufacturing; planning and testing methods of manufacturing; developing methods for the treatment of bi-products; devising production processes that are safe, efficient, profitable and environmentally sound; October 3-5, 2012, Bangkok, Thailand For details contact: School of Information Technology Tel: +66 2470 9834 Fax: +66 2872 7145 Email: email@example.com Website: www.csbio.org
CPhI Worldwide The event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain
For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: firstname.lastname@example.org Website: www.ubmindia.in
2012 Nanotechnology Conference The event aims to bring together a panel of highly-accomplished nanotechnologists and well recognised authorities in various aspects of nanomedicine. This unique international conference offers an opportunity for pharma scientists, clinical researchers, physicians, therapists and industrial leaders to discuss the important international breakthrough developments in drug discovery, drug development, drug delivery, drug therapy and commerce to share their thoughts. The four-day conference will focus on the basic studies through translational efforts and clinical trials and address topics of novel issues concentrating more on recent advances, difficulties, and breakthroughs. This is how the event aims to reach out to the experts and decision makers of industry; October 31- November 3, 2012, Riviera Maya, Mexico For details contact: Zing Conferences Tel: +44 1223 750020 Fax: +44 1223 280270 Email: email@example.com Website: www.zingconferences.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.
Modern Pharma•16-31 Augus t 2012
Editors: Joseph Boullata and Vincent Armenti Price:
Publisher: Humana 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: firstname.lastname@example.org
Drug Safety Evaluation: Methods and Protocols
Editor: Jean – Charles Gautier
This book serves as a resource document in the various avenues of drug safety evaluation. The step-wise approach in each chapter relating to a particular drug safety evaluation technique is a hands-on reckoner to the pharmaceutical scientist or biochemist performing the task of drug safety evaluation. The Part 1 on general toxicology provides details of toxicology assessment in adults and paediatric population and planning of pre-clinical studies for the same. Part 2 deals with autopsy findings in lab animals and methods to process drug-related information for autopsy specimens. Parts 3 and 4 are dedicated to techniques evaluating toxicities to the genetic material and cardiac cells, respectively. The chapter on evaluation of cardiac safety with respect to arrthymia potential is one of the highlights of the book. Part 5 deals with advanced evaluation technologies when unexpected toxicology results happen. A dedicated section to effect of drugs on the embryo and fetal development in an animal model is explained in part 6. Part 7 of the book deals with technologies developed to assess such adducts using sophisticated mass spectroscopy. It is a great book for practical day-to-day use in a toxicology lab by chemists, scientists, and biotechnologists because of its check list type of presentation of every step in drug safety evaluation techniques.
Publisher: Humana 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: email@example.com
Handbook of Drug–Nutrient Interactions The editors have compiled a good book covering the basics of both drug and nutrient absorption to individual interactions in details. The language is easy and free flowing, made easier with numerous tables, which may serve as checklists. Part 1 of the book deals with pharmacokinetics, pharmacodynamics, cellular transport mechanisms of drugs and also a revision of the digestion–absorption process in the human body. Part 2 deals with two extreme situations of malnutrition and obesity and their impact on drug therapy and vice versa. Part 3 deals exclusively with interaction of food, nutrients and/or supplements with drugs and their effects. A dedicated chapter on fruit juices and their interactions is a must read for every member of the healthcare team and patients in general. The chapters on parenteral feeding and enteral feeding give a perspective on these special situations, the nutrient interaction and requirements of such patients and the drug interplay. Part 4 encompasses dedicated chapters describing in brief the impact of cardiac and neurological medications on the nutritional status. Part 5 looks at drug–nutrient interactions from a life cycle point of view. The concluding part 6 of the book dedicated chapters specifically to the increasing burden of cancer, immune dysfunction, transplantation and chronic infections. The book thus stimulates a sense of scientific discovery with respect to nutrient drug interactions and also serves as basis of incorporating allopathic and traditional medications o jointly alleviate diseases. A must read for every physician, dietician, pharmaceutical chemist and practitioners of traditional medications.
Reviewer: Dr Mandar Kubal, Consultant - Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC) Pvt Ltd
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regulatory systems Roundta duces OneL AS healt Putting challenges operations ble 23 ab Should the worldh care syste on track India tax ms aroun air ticket as labou face chall d pay for enges AIDS drugs s to such regulation r short ages, proposed as incre ased by the UN? they rely and budget constraints on techn manage , ology to help in addre the impact. To assist ssing Abbott these IDEA L anno challenges Web-based unced OneL Cure , s extended ab, a new, has devel informatic , integrated Instamode delivery syste oped an labor highly-con s solution. OneL atory m name l that of any allow figur d ab s the is a able platfo drug for allows labs release time with a longe processes of any size to rm that r perio medication continuous d of on specia standardise and automacross multiple lised excip to patien availability thereby value to locati of ate routi ients that t or such as cuts ne proce ons will such doses the frequency user, and the manu the products dures tracking, sample mana and facilitadd have to at gement Suresh product facturing and as ate be admi which Paree and and appro well as test quality enhan nistered. result review “Instamode k, MD, Ideal the futur and attrib ce the val. e utes. sized pharml will be target Cures said, “We have plans Paree k comm On Taro Boar ing the very have prope a companies midented future offer for d rejects Sun and woulambitious plans developme r infrastructuwho do not double complete d like Pharma for TARO digits re nt to grow and still for the (about have the Pharmaceut acquisitio percentage in they would Extended board has on yearly 30 per cent) ical Indus n like products science Release of basis. Ours tries’ and resea Pharmaceutrejected an offer in the mark (ER) range to will can rch and our et. Other of also its issued ical Industries from Sun approach based organisatiobe custo technical use our exper innovative to purch will be and outst t system mers not held support ase to bring n anding s and expenses to reduc pharma products to suppo by the out share e due to Indian for indus s rt grow pharma the simpl development. the time and inade ing Elaborating try.” firm Committee quate price. These est of the on its busin allow the and its solutions will be “Special Pareek unanimous of Board conve future that will of up to produ ntional or Pareek expanding ess in India added, 2011 unsolly rejected the Directors prevailing ce specia “Our majo strategies, products October of now from Sun icited, non-b 18, at no extra lised high qualitset many more is r inding to 90 per in India and business as Pareek y the cost.” are on offer to purch Pharmaceutical the reven the anvil. work on Instamodeladded, “The proje by dome cent extent ase ue neutral Besid outstandin all of the Industries comp stic busin is contribute cts on have come for ER tablet issued the comp ounds and some spheres, coolines business d ess only. s formu and currently g shares of devel up with g majo osition new film lations Taro several held by The is unde r objec opment globa coating $ 24.50 products While Sun Pharm not r progr lly is our per we would tive and in and ess.” a for in the best share as inade business film coating next like 5 years quate to see Ideal cures 25 -30 per is appro shareholde interests of Taro’ and not cent also plans its core by off shore revenue being ximately to focus Pharmaceutrs,” a statem s minority generated supplies.” ical’s websi ent on Taro te stated . Piram -
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to SHASUN PHARMA post diversifi be Pharmaceut Ltd is cation icals all set will be major Piram to al Healt facility hcare at Naidu establish a Enterprise renam ed peta, as Piram Pradesh. s follow And hence Andhra entry capacity into diver ing its recenal efforts , constant of are activities. t sified intermediat 12,000 tonne decreasing being made of es. Elabo four years The rechristeni business dependence at in this Kumar Chinese ratin after Nich ng comes became on highlights regar d, Kum g company added that the olas Piram business. imports for Piramal ar recru is plann appropriate The its al Healthcare will be , “This facili ing to of the larges company is . “To primarily ty rema it 100 peop one changed ly reflect the t two manu le. He rked, of company’s factur objec tives serving pain proposed business profi at chem “We are looki there mana gemeers . First drug Ibupr istry gradu ng woul company that the namele, it is nt ofen. depe nden d be non-, chemical ates or Acco be of Kumar changed rding Enterprise the with us.” engineers to work for suppl ce on Chin to Abha Kum ar, to Setting y and a is not Chairman, s Ltd,” Ajay Piramal y on up a facilit would second PharmaceutMD, an easy a 50-ac Piramal, Shas un y be it job to be at the annuPiramal Healt assur Talki icals Ltd, re land time Naid upeta ance facility, hcare done. al gener of he ng about the in produly avail abilit the to under , is al meeti , stated hurdl reiterates, constructio expec y of cts.” He start ng. Zydus Uros “Technologes, n Marc opera tions ted that further remains still a challe h 2013 y by woul the total inves added have Udenafi ciences laun with an nge. to find l d be tmen annual ches ZYDUS cost effectWe `100 crore approxima t ways in Uroscienc ive tely order . division to with the es, the of STR IDES specialty Chinese compete Udenafil Zydus Cadila prices.” has a announced Arco lab - Chandr treatment next gen thera launched eyee Bhaum Developm that Proparco,Ltd has py for ik (ED). Udenof Erectile the comp a Frenc Dysfunctio has inves ent Financing afil, a h Afric any with the potent n Instit newly philosophy a for Afric and form of ted $ 12.50 millio ution, developed, of ’In a’. approved selective PDE5 Strid es most attrac 20 per equity participation in the has been been launcfor the treatment inhibitor cent Afric a of tomo tive business prese and contr front-end stake in Strid n for a of ED, has hed unde oppo Udzire. rrow and impr es’ Afric ibuti ng nt in with The group r the brand name operations arm, valuing an manuovem ent of this partnrtunity to the Prop license the Afric at ership our commarco further to mark has an exclu an wide factu ring and healt hcare The proce about $ 60 sive molecule stren et this by millio itmen gthen range of eds mark eting quality n. creat e paten lifesaving Pharmaceutdeveloped and timel t to prov idings lifest yle addit ional will be used by Dongted infra struc antibioticsa Afric ans. disea se y icals of manu factu to and -A relate d Crea tion medication Korea, ture in , manu nutri ring Afric a to in India curat ives key mark factu of form ulatio tion/ relief and to . ets in also prov ring infra strucaddit ional prov iding build ns. Sinhu CEO a regio ture will ide large oppo nal Arco , Afric a Oper e Noro nha empl – to rtunities and ation lab Ltd, economic oyme nt all assoc said, “Afri s, Strid es iated grow African ca is the Business with the Strid th belief that es’ and life is mostreinforces our precious”
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Modern Pharma•16-31 Augus t 2012
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
Gas detector Gasman pockettype gas detector (monitor) is small, lightweight and easy-touse in tough environments. It weighs between 105-130 gm, depending on the sensor type. It is durable with high impact resistance and ingress protection to IP65/67. When a hazardous gas is detected, the device alerts the user with a loud 95 dBA alarm, a bright red blue visual warning and also by vibrating. It is small enough to fit easily into to a top pocket or clip on to a belt or lapel. It features single button control and full interchangeable I-module intelligent sensors for oxygen, toxic and flammable gas monitoring. Detection Instruments (I) Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27617663 Email: firstname.lastname@example.org Website: www.detection-india.com
plate is suitable for mounting inside the equipment. The pump can be modified to suit specific requirements.
motor with gear boxand the diving nozzles is used for prevention of spillage and for foamy liquids.
Acmevac Sales Pvt Ltd Mumbai - Maharashtra Tel: 022-28375837 Email: email@example.com Website: www.acmevac.com
Harshika Industries Dist Thane - Maharashtra Tel: 0250-3246533, Mob: 09869457909 Email: firstname.lastname@example.org Website: www.filling-machinemanufacturer.com
Tablet coating system
FRP storage tank
The tablet coating system is available in various models from laboratory scale up to tonnage capacity. All models are in compliance with GMP requirements. Features include pan construction with air-tight cover to provide good condition for mixing and drying. For sugar-coating, the hot air supply and the exhaust can be automatically controlled by the auto damper and the sequence spray-pause-1, pause-2, dry is automatically operated by the preset timer. The reverse rotation discharge system, discharges with simple operation without any damage of tablets.
The FRP storage tank is manufactured by hand lay-up and/ or by filament winding process for the storage of highly corrosive chemicals, acids and wastes. It is available in capacity up to 250 kl in various shapes, like square, round, rectangular vertical and horizontal with flat bottom or conical bottom. The key feature of this tank is that it offers resistance to chemical and weather. It is lightweight, easy-tomaintain featuring good physical and mechanical strength. The reaction vessel is available with suitable lined agitator, gear box and electric motor.
Powder characteristics tester The Hosokawa PT-X powder characteristics tester employs methods to determine the flowability and floodability of dry powders. This model is the latest design of the powder characteristics tester, which utilises stateof-the-art features to identify the specific characteristics of powdered samples for a wide range of application fields. Features are automated vibration with electronically controlled vib-sensor for repeatable results, optional integrated HEPA filter dust protection, test sieve identification measure by recording test sieve serial number, complete powder characterisation in one instrument, reduced operator intervention insuring analysis accuracy and repeatability, userfriendly software, reduce analysis time, complies with FDA tapped bulk density (USP) ASTM, Kawakita’s equation for Compressibility, etc. Hosokawa Micron India Pvt Ltd Chennai - Tamil Nadu Tel: 044-26211257 Email: email@example.com Website: www.hosokawamicron.co.jp
Umang Pharmatech Pvt Ltd Dist Thane - Maharashtra Tel: 0250-6450835 Email: firstname.lastname@example.org Website: www.umangpharmatech.com
EPP Composites Pvt Ltd Rajkot - Gujarat Tel: 02827-287059 Email: email@example.com Website: www.atikagroup.com
Work bench The work bench features steel frames, panels and shutters made from prime quality CRCA steel. This steel is coated with epoxy paint and a special encapsulated powder that has a film thickness of 40-60 microns. This imparts a high scratch-resistance and the encapsulated powder ensures that no oil or chemical marks are formed on the surface. Every shelf on the cabinet is equipped with a load carrying capacity of 40 kg UDL to ensure maximum efficiency in the cabinet drawer. High-precision double-extension ball slides are used. Godrej & Boyce Mfg Co Ltd Mumbai - Maharashtra Tel: 022-67964363, Mob: 09920113138 Email: firstname.lastname@example.org Website: www.godrej.com
Temperature and process controller Fuji Electric’s self-tuning temperature and process controller has low-cost options that include RS485 communications, digital input, timer function, heater burnout alarm, dual outputs, and programmable alarms. The faceplate is watertight and corrosionresistant. The three-button keypad allows programming and the screw-terminal on the back eliminates the need for sockets. In addition to auto-tuning and fuzzy control, it has self-tuning control, which automatically retunes the controller under certain conditions, without the need to revert to auto-tuning. It accepts temperature & process inputs and offers two control outputs and two programmable alarms.
Liquid filling machine Rotary vacuum pump This is a sliding vane, oil-lubricated type rotary v a c u u m pump. The design of the lubricating system positively feeds minimum quantity of oil to important points. The oil from the exhaust is baffled, collected and returned back to the oil chamber. Heat treated fibre vanes are used in the pumps in place of stator, end covers and rotor slots. The pump is driven by V-belt and is fan-cooled. The complete unit with motor and base
The four-head liquid filling machine is a highly versatile machine for filling foamy as well as other liquids into containers. It has a unique bottle separation method in which no turret or holding slides are used. This machine fills the liquid using the syringe principle and is very easy to use. Turntable is provided for bottle filling. This liquid filling machine is provided with variable speed conveyor and is suitable for filling all types of liquids with less density. It is equipped with 1.5 HP
Procon Technologies Pvt Ltd Ahmedabad- Gujarat Tel: 079-27492566, Mob: 09824310188 Email: email@example.com Website: www.procon.co.in
Pallet shrinking tool The pallet shrinking tool is used for shrink wrapping. S h r i n k wrapping of export pallets, giant pallets, giant articles, big articles/machinery are used to avoid
damage during transportation. Boxes on pallets and other products can be shrinkpacked within minutes. It provides fivesided protection for any size or shape load from small uneven pallets to large machinery and more strength than stretch wrapping. The tool is compact, portable and handy weighing 950 g. Dharmesh Enterprises Mumbai - Maharashtra Tel: 022-55233591 Email: firstname.lastname@example.org Website: hotairguns.com
Aristocrat electric blankets are waterproof, shockproof, autocut, soft underlay to provide constant slow motherly warmth. It is a relief for the patients of asthma, gout-arthritis, backaches, bodyaches & pains, patients of diabetes, low blood pressure, and the aged alike. These blankets supplement the much needed body energy and are useful for senior citizens. Medico Pharmaceuticals Processors Amritsar – Punjab Tel: 0183-2258586 Mob: 09356000059 Email: email@example.com Website: www.medico.co.in
Gas flow adsorption analyser The model SGA100 is a continuous gas flow adsorption analyser is specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version), 250°C (hightemperature version), at an ambient pressures. The term symmetrical refers to a design feature where by both the sample side and the reference side of the microbalance is subjected to identical temperature, relative humidity and flow rate. This provides significant stability and accuracy and allowing the possibility of performing absolute or differential adsorption experiments. The instrument is used in industries such as catalyst, chemicals, pharmaceuticals, foods, electronics, etc. Smart Instruments Company Thane - Maharashtra Tel: 0251-2801123, Mob: 09323509969 Email: firstname.lastname@example.org Website: www.smartinsrument.com
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 Pharmaâ€˘16-31 Augus t 2012
Modern Pharma•16-31 Augus t 2012
30 List of Products & Advertisers 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 Product
Activated carbon filter .........................................BC
FRP cable tray ............................................................ 7
O rings .................................................................... 29
Squares ...................................................................... 29
Auto l - sealer ........................................................... 29
FRP canopy ................................................................ 7
Oil seal....................................................................... 29
Stainless steel pipes .................................................. 29
Autoclave gaskets ..................................................... 29
FRP grating................................................................. 7
Pallet shrinking tool.............................................. 28
Strapping machine .................................................. 29
FRP handralls & fencing........................................... 7
Pallet wrapper .......................................................... 29
Stretch wrapper........................................................ 29
Barcode & inkjet printer ...................................... 29
FRP ladder .................................................................. 7
Paperless recorder .................................................... 11
Barcode patient id bands ........................................ 29
FRP luminaries .......................................................... 7
Powder characteristics tester................................... 28
Tablet coating system............................................ 28
Blowers ...................................................................... 23
FRP poles & mast ...................................................... 7
Pressure sand filters ................................................BC
Tableting machines .................................................. 21
Braided house........................................................... 29
FRP storage tank................................................... 7,28
Printer ....................................................................... 29
Tapping - straping machine ................................... 29
Bulk bag filler ........................................................... 29
FRP structural profiles .............................................. 7
Product demos ......................................................... 29
TC gaskets ................................................................. 29
Gas detector............................................................ 28
Temparature & humidity measuring solutions ..... 3
Gas flow adsorption analyser ................................. 28
Rapid endotoxin detection system...................... 29
Temparature & process controller ......................... 28
Cap sealer - induction sealer .................................. 29
Reverse osmosis unit ............................................... bc
Temparature controller ........................................... 11
Continuous bag sealer............................................. 29
Gas flushing machine.............................................. 29
Rotary vacuum pump ............................................. 28
Tradeshow organizer ............................................... 29
Cords ......................................................................... 29
Gaskets ...................................................................... 29
Seals ......................................................................... 29
Transparent tubings................................................. 29
Corona treater sleeves ............................................. 29
Hand sealer............................................................. 29
Seamless pipes .......................................................... 29
TRI lobe roots blowers............................................ 23
Customized machine............................................... 29
Hot air gun ............................................................... 29
Sections ..................................................................... 29
Tubes ......................................................................... 29
Data logging system ................................................ 3
Inflatable gaskets ................................................... 29
Sheet .......................................................................... 29
Twin lobe roots blowers.......................................... 23
Demineralization plant ........................................... bc
Integrated machine safety solutions........................ 9
Shrink machine ........................................................ 29
‘U’ tubes .................................................................. 29
Digital panel meter .................................................. 11
Labels ...................................................................... 29
Silicone rubber sleeves ( ITI approved) ................ 29
Ultra filteration systems .......................................... bc
Electric blanket ...................................................... 28
Large diameter welded pipes.................................. 29
Silicone transparent platinum cured tubings....... 29
Ultra sonic flow meter ............................................ 11
Electro de ionization. .............................................. Bc
Liquid filling machine ............................................. 28
Single use bioreactor ............................................... fic
Vacuum conveyor. ................................................. 29
Exhauster .................................................................. 23
Liquid sealer ............................................................. 29
Sleeve wrapping machine ....................................... 29
Vacuum machine ..................................................... 29
FBD gasket ............................................................. 29
Machines and plants for dry & wet
Sleeve wrapping machine strapping machine ..... 29
Welded pipes .......................................................... 29
Foot sealer................................................................. 29
Softening unit........................................................... bc
Wireless data monitoring systems ........................... 3
FRP battery stand ...................................................... 7
Mechanical vacuum boosters ................................. 23
Sponges ..................................................................... 29
Work bench .............................................................. 28
BC-Back cover, BIC-Back inside cover, FIC-Front inside cover
Advertiser’s Name & Contact Details
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Allpharm Technologies Pvt Ltd T: +91 22 26849100
Testo India Pvt Ltd Rockwell Automation
Thermo Fisher Scientific India Pvt Ltd
Shende Sales Corporation
TSA Process Equipments Pvt Ltd 17
T: +91 22 6716 2200
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Techno Industries T: +91-2762-224814
Great Eastern Impex Pvt Ltd
Procon Technologies Pvt Ltd
W: www.netzsch-grinding.com/pharma 21
Suzhou Glory Exhibitions Co Ltd
Our consistent advertisers
RNI No: MAHENG / 2008 / 27125, Postal Regd No: G / NMD / 122 / 2011 - 13, Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month, Date Of Publication: 16th Of Every Month
Published on Jul 31, 2012
Published on Jul 31, 2012
Modern Pharma is a leading fortnightly business magazine in India, catering to the pharmaceutical industry. Published by Network 18 Ltd., it...