Best Pharma Companies in India by Nadimidoddi Prasad

Contents

Indian Pharma Industry on the rise

Top Pharma Giants of India

Page No: 6

Page No: 9

AP’s Generic Outlook Page No: 14

DESIGN

CHAIRMAN OF THE BOARD : VIVECK GOENKA, ASST. VICE PRESIDENT : BIJU MATHEWS, PROJECT MANAGER: VIJAY KULKARNI, CHIEF MANAGERS : ANTHONY DANIEL, Y. S. VENKAT SWAMY, SR. MANAGER : A.K. SHUKLA, MANAGER : L. FRANCIS FARIAS, REPORTER : AMGUTH RAJU, & LAYOUT : N. PRASAD, PRODUCTION & CIRCULATION : M.E.A. MUJAHID, PHOTOGRAPHER : M. VIDYA SAGAR RAO, EXECUTIVE : B. NARESH, SUPPORT & CO-ORDINATION : M. NARENDER, IT SUPPORT : R. SUMAN KUMAR

COPYRIGHT : THE INDIAN EXPRESS LIMITED. ALL RIGHTS RESERVED. REPRODUCTION IN ANY MANNER, ELECTRONIC OR OTHERWISE, IN WHOLE OR IN PART, WITHOUT PRIOR WRITTEN PERMISSION, IS PROHIBITED. ARTICLES BY CONTRIBUTORS ARE SOLELY THE AUTHOR’S VIEWS. THEY DO NOT REFLECT THE PUBLICATION’S VIEWS. ALL CORRESPONDENCE SHOULD BE SENT TO : THE INDIAN EXPRESS LIMITED, BUSINESS PUBLICATIONS DIVISION, 6-3-885/7/B, GROUND FLOOR, V.V. MANSION, SOMAJIGUDA, HYDERABAD-82, TEL: 23418673, 23418674/675, 66631457, TELE FAX : 23418675 E-MAIL : BPD.HYD@EXPRESSINDIA.COM, WEBSITE : WWW.EXPRESSINDIA.COM

Indian Pharma Industry on the rise

THE RISE OF INDIAN PHARMA INDUSTRY HAS BEEN PHENOMENAL SINCE 2004, THE DOMESTIC AT 8.9 PER CENT PER ANNUM, WHICH IS LIKELY TO TOUCH $ 20 BILLION BY 2015

MARKET HAS BEEN GROWING

December-2010

he Indian pharmaceutical industry is one of the fastest growing sector of the Indian economy and has made rapid strides over the years. From being an import dependent industry in the 1950s the industry has achieved self sufﬁciency and gained global recognition as a producer of low cost high quality bulk drugs and formulations. In the last few years several pharmaceutical companies have demonstrated that they possess the ability to engage in commercially viable research and development activities and become signiﬁcant players in the world. Healthy growth of this industry was visible in 2004 in the wake of higher exports, increased focus on acquisitions, and exploration of new markets. Indeed, this industry has geared itself well to seize the opportunities in the challenging international environment post 2005. Today, India is one of the top 5 manufacturers of bilk drugs in the world and is among the top 20 pharmaceutical exporters in the world. The industry manufactures almost the entire range of therapeutic products and is capable of producing raw materials for manufacturing a wide range of bulk drugs from the basic stage. In the recently conducted study of ASSOCHAM it has been found that the current world market is US$521 billion with Indian market accounting for US$7.5 billion (inclusive exports). India accounts for 8 percent of world’s production by volume and 1.5 % by value. India’s exports have been growing at a CAGR of 22.9 % and reached US$ 3 billion in FY 2004. The domestic market has been growing at 8.9 % per annum. It is expected that India’s total Pharma market (domestic & export) would grow from US$ 7.5 billion to US$ 15 billion plus US$ 5 billion of 5 billion of chemical services by 2010. Domestic markets may reach a size of US$ 9 billion by 2010 and exports US$ 12 billion (inclusive of US$ 4 billion services)

December-2010

The Indian Government has taken measures to give impetus to domestic production of drugs and formulations, creating an environment conducive for channeling new investment into the pharmaceutical sector. However the industry is of the opinion that new policy initiatives should be announced particularly relating to some research and development (R&D) and pricing regime in order to propel the industry into a high growth track as well as to face the challenges of a WTO led trading system. Some important areas which need immediate attention include, implementation of the recommendations of the Expert committees Report on a comprehensive Examination of Drug regulatory issues including the problems of spurious Drugs. These recommendations are intended to help prepare the Health Ministry to strengthen regulation in this vital industry. Secondly, expeditious strengthening of the physical software and human infrastructure in the patent ofﬁces is the need of the hour. Assessing the issue relating to data exclusivity needs to be examined and the role of SSIs in the sector needs clarity and if any steps are required they should be documented and presented to the planning commission.

Other important area that needs attention pertains to the issues relating to human capital including setting up of new institu-

tions investment in pharmaceutical R &D has been rising steadily, as the industry has come to realize the importance of R&D and as its gamuts is now spreading across various areas such as, new chemical entities (NCE’s) novel drugs delivery systems (NDDS), Process development activities and Clinical research trails. The R&D investments are projected to rise from Rs 320 crore in 1992000 to Rs 1500 crore by 2005. At present, R&D spends account for 5 per cent of the pharmaceutical turnover. Research and Development cost in India are much less than those in the developed world and it is possible to conduct both New Drug Discovery Research center and novel drug delivery system programmes at competitive rates. Apart from comparative cost advantages Indian R&D efforts are also added by the presence of a well established network of research laboratories and skilled pool of scientiﬁc personnel. Right now the Pharmaceutical industry is going through a transition phase. On 1st January 005 the product patent regime came into force. Drugs patented after January, 1995 will no longer be allowed to be reverse engineered and copied. This means that In-

dian companies, scientists and researchers have to align themselves to a new environment R&D in the Indian Pharmaceutical industry is gaining momentum, as 7

more and more innovator companies in regulated markets are keen to tap Indian intellectual inputs in this respect, apart from availing of our low cost production capabilities. The next decade will see more global partnership and made in India drugs making their debut on world state. There are immense opportunities in pre-clinical outsourcing and clinical test outsourcing too. Most Indian companies realize that it will be difﬁcult for them to commercialize their discoveries on an international basis on their own. Therefore they are entering licensing deals and strategic alliances with international companies. This way their development costs will get shared and returns will accrue faster in terms of Drug Master File (M/DMF) submission during 19982003. India is a clear leader in comparison to china, Italy, Spain and Israel. Further with India garnering highest approval from USFDA for plants outside US it is likely that USFDA would be setting up a permanent ofﬁce in India.

A critical challenge to the Pharma industry is the reduction of the cos t and time frame from discovery to marketing a drug. The increasing cost of drug discovery can be attributed largely to the declining R&D productivity(high attrition rates and cost of failures) and increasing regulatory demands at the USFDA in terms of highest number of patients in clinical trials) for drug approval. The application of new age technology like high throughput screening genomics combinational chemistry and bio-informatics are capable of signiﬁcantly bringing down the attrition rates and addressing the productivity problems. However competitive advantage would go to ﬁrms that best control clinical trials which alone account for a third of the total cost of drug development and almost half the time taken. Many Pharma majors are meeting this challenge by conducting clinical trials for their drugs in developing countries like India, where cost are one-seventh of that in the EU & USA. The need to reduce the time

and cost also explains the increasing trends towards outsourcing research to Contract research organization and partnering and alliances between pharma-pharma and pharma-biotech for joint research and development. Global competitiveness will be the key to growth and survival under the new IPR regime. The greater incentive for original drug discovery will create opportunities for Indian companies to develop new competencies through collaborative research global alliances and will at the same time make India a more attractive destination for global Pharma majors for establishing their R&D bases. The new product processes are getting unbundled as contract research contract manufacturing and clinical trails are expected to create new opportunities for focused service providers. The Indian Pharma Industry is expected to witness a lot of consolidation through M&A activities for promoting economics of size and scale.

December-2010

Top

Pharma Giants of India

A rollcall of the top pharma companies of India reveals the vision of the founding fathers of these entities, which today are present in global geographies

Ranbaxy Ranbaxy Laboratories Ltd (Ranbaxy), is a member of the Daiichi Sankyo Group, a leading global pharma innovator, headquartered in Tokyo, Japan. The combined entity now ranks among the top 20 pharmaceutical companies, globally. The transformational deal has placed Ranbaxy in a higher growth trajectory and it will emerge stronger in terms of its global reach and in its capabilities in drug development and manufacturing. The Gurgaon-based Ranbaxy is an integrated, research based, international pharma company, producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy today has a presence in 23 of the top 25 pharmaceutical markets of the world. The Company has a global footprint in 46 countries, world-class manufacturing facilities in 7 countries and serves customers in over 125 countries. It has focused on increasing the momentum in the generics business in its key markets through organic and inorganic growth routes. Growth is well spread across geographies with focus on developed and emerging markets. It is the company’s constant endeavour to provide a wide basket of generic and innovator products, leveraging the unique Hybrid BusiDecember-2010

ness Model with Daiichi Sankyo. The company will also increasingly focus in high growth potential segments like Vaccines and Biogenerics. These new areas will add signiﬁcant depth to the existing product pipeline. In 2009, North America, the company’s largest market contributed sales of US $397 million, followed by Europe garnering US $ 269 million and Asia clocking sales of around US $ 441million.

Dr. Reddy’s Laboratories The company established in 1984, Dr. Reddy’s Laboratories (DRL) it is an emerging global pharmaceutical company. As a fully integrated pharmaceutical company, it is to provide affordable and innovative medicines through three core businesses. Pharmaceutical Services and Active Ingredients, comprising its active pharma and custom pharma businesses. The Hyderabad-based DRL has 16 world-class manufacturing facilities of which nine have a long history of regular US FDA inspections. With an annual capacity of nine billion tablets/ capsules a year, dedicated to servicing the more regulated markets, one of DRL’s ﬁnished dosages facilities is among the largest in Asia. DRL’s facilities are designed to respond to a wide range of technologies - oral solids, injectable, topicals, inhalers, cytotoxic, hormonal and other dosage forms. Likewise its API facilities offer lean manufacturing, adhere 9

to stringent regulatory guidelines and continually drive cost competitiveness. Such manufacturing capabilities and its inherent expertise to navigate intellectual property road blocks make us a preferred partner for some of the world’s leading pharma companies.

has developed the ﬁrst-of-its kind ‘Mother-Baby Pack’ in collaboration with UNICEF and other partners . It has also introduced Pirfenidone in India; under the brand name Pirfenex, for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

The company’s product are marketed globally, with a focus on India, US, Europe and Russia. Dr. Reddy’s conducts New Chemical Entities (NCE) research in the areas of metabolic disorders, cardiovascular indications, anti-infectives and inﬂammation. Global Generics, which includes branded and unbranded generics; and proprietary products, which includes NCEs, differentiated formulations, and generic biopharmaceuticals.

Sun Pharma Industries

Cipla

Initially based in Vadodara, Sun Pharma came into existence as a start-up with just ﬁve products in 1983. Now based in Mumbai, the company has crossed several milestones to emerge as one of the leading pharma companies in India. Post 1996, the company used a combination of internal growth and acquisitions to drive growth; important mergers were those

Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India self-reliant and self-sufﬁcient in healthcare. Over the years Cipla has

emerged as one of the most respected pharma names not just in India but worldwide. Its R&D centre has given the country and the world many ﬁrsts. This includes the revolutionary HIV/AIDS cocktail for less than a dollar a day. With over 40 state of the art manufacturing units across the country, the Mumbai-based Cipla manufactures over 1200 products in 80 therapeutic areas. With a turnover of over US $ 1.2 billion, Cipla serves doctors and patients in over 180 countries. It has earned a name for maintaining one global standard across all its products and services. Cipla continues to support, improve and save millions of lives with its high-quality drugs and innovative devices. Recently, the company 10

1993 and this created a base of strong product and process development skills. With world-class technology and a team of strong professionals, the company has built sites and systems that meet the most stringent international manufacturing standards. Expert quality teams ensure that systems and processes remain in compliance with the latest standards. A number of the plants hold approvals from the USFDA and the UK MHRA. APIs and Dosage forms are made in 15 sites across India, US, Hungary and Bangladesh. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms.

Natco Pharma Limited

of the US, Detroit based Caraco Pharma Labs and more recenlty the Israeli Taro Pharma. Realizing the fact that research is a critical growth driver, Sun Pharma established a separate research center SPARC in

Natco Pharma Limited is a pharmaceutical company based in Hyderabad. It has four manufacturing facilities & employs 1,500 people. The company makes branded & generic dosage forms, bulk actives & intermediates. It is also involved in contract research & manufacturing. It is also a well known manufacturer of a range of branded and generic dosage forms, bulk actives and intermediates for both Indian, as well as international markets. The products manufactured by the Company include Diltiazem, Omeprazole , Lansoprazole, Isosorbides, Sumatriptan succinate, Ondansetron, Sertraline, Granisetron and Paroxetine. The Company’s products comes in various forms, such as timed released capsules, tablets, inhalers, dry syrups, dispersible, syrups and suspensions, ointments, gels, injectables, infusions, sterile preparations and large and small volume parenterals. The Company operates in two business segments: bulk chemicals and ﬁnished dosage formulations. The wholly December-2010

owned subsidiary of the Company is NATCO Pharma Inc.

Lupin Lupin Ltd is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The company’s vision is achieving the distinction of becoming one of the fastest growing generic players globally. The Mumbai-based Lupin first gained recognition when it became one of the world’s largest manufacturers of tuberculosis drugs. Over the years, the company has moved up the value chain and has not only mastered the business of intermediates and APIs, but has also leveraged its strengths to build a formidable formulations business globally. The year 2008-09 was yet another year with impressive growth of 32 percent in revenue and 50 percent (excluding IP income) in profits. Over the last five years, the company has recorded a CAGR of 31 percent and 53 percent in sales and net profits respectively. The company has significant market share in key markets in the Cardiovascular (prils and statins), Diabetology, Asthma, Paediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not to mention global leadership positions in the Anti-TB and Cephalosporins segments. Its R&D endeavours have resulted in significant progress in its NCE program. The company’s foray into advanced drug delivery systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.

Aurobindo Pharma Founded in 1986 by P V Ramaprasad Reddy, K Nityananda Reddy and a small, highly committed group of professionals, Aurobindo Pharma became a public venture in 1992. It commenced operations in 1988-89 December-2010

with a single unit manufacturing semi synthetic penicillins (SSPs) at Pondicherry. It had gone public in 1995 by listing its shares in various stock exchanges in the country. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. Over the years, the Hyderabad-based Aurobindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country manufacturing facilities, and is becoming a marketing conglomerate across the world. The formulation business is systematically organised with a divisional structure, and has a focused team for each key international market. Aurobindo believes in gaining volume and market share in every business/ segment it enters. The company has invested signiﬁcant resources in building a mega infrastructure for APIs and formulations to emerge as a vertically integrated pharmaceutical company. Aurobindo’s ﬁve units for APIs and four units for formulations are designed for the regulated markets.

GlaxoSmithKline Pharma GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company globally and one of the ﬁrst to start operations in India. The GSK India product portfolio includes prescription medicines and vaccines. The company’s prescription medicines range across therapeutic areas such as anti-infectives, dermatology, gynaecology, diabetes,

oncology, cardiovascular disease and respiratory diseases. The Mumbai-based GSK India is the market leader in most of the therapeutic categories in which it operates. GSK also offers a range of vaccines, for the prevention of hepatitis A, hepatitis B, invasive disease caused by H, inﬂuenzae, chickenpox, diph-

theria, pertussis, tetanus, rotavirus, cervical cancer and others.GSK is committed to developing new and effective healthcare solutions. The values on which the group was founded have always inspired growth and will continue to do so in times to come.

Cadila Healthcare Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group’s operations 11

pany with a strong thrust on exports. Ipca’s APIs and Formulations produced at worldclass manufacturing facilities are approved by leading drug regulatory authorities including the US-Food and Drug Administration (FDA), UKMedicines and Healthcare products Regulatory Agency (MHRA), South Africa-Medicines Control Council (MCC), Brazil-Brazilian National Health Vigilance Agency (ANVISA) and Australia-Therapeutic Goods Administration (TGA). With operations in over 100 countries, exports account for over 52 percent of the company’s income. Ipca is one of the biggest manufacturers in the world of APIs Atenolol (Antihypertensive), Chloroquine Phosphate (Antimalarial), Furosemide (Diuretic)

range from API to formulations, animal health products and cosmeceuticals. Head quartered in Ahmedabad, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With over 10,000 employees worldwide, a world-class research and development centre dedicated to discovery research and eight state-of-the-art manufacturing plants, the group is dedicated to improving people’s lives.

Aventis Pharma Aventis Pharma Ltd was incorporated in May 1956 under the name Hoechst Fedco Pharma Pvte Ltd. Over the years, its name was changed to 12

Hoechst Pharmaceuticals Pvt Ltd, Hoechst India Ltd and Hoechst Marion Roussel Ltd. Sanoﬁ-aventis, one of the world’s leading pharmaceutical companies, and its 100 percent subsidiary, Hoechst GmbH, are the major shareholders of Aventis Pharma Ltd and together hold 60.4 percent of its paid-up share capital. The Mumbai-based Aventis Pharma Limited in India provides medicines for the treatment of patients in several therapeutic areas: cardiology, thrombosis, oncology, diabetes, central nervous system and internal medicine. Throughout 2010, the Company’s plan was to incur planned expenditure in two critical projects-slated to be growth drivers : “Prayas”- a project to deliver high quality low cost healthcare to the rural population and entering the Over-The-Counter (OTC) market.

Ipca Laboratories Ipca is a fully integrated, rapidly growing Indian pharmaceutical com-

and Pyrantel Salts (Anthelmintic) right from the basic stage. Ipca is also one of the largest suppliers of these APIs and their intermediates world over. Ipca is a globally acknowledged Anti Malarial company and has forged strong links with WHO, UNICEF, Global Fund, Clinton Foundation, MOH in Africa and other major stakeholders. Ipca has a Special Task force formed (around 20 committed Team members) to understand the issues and challenges of Malaria diseases. Ipca has 33 years experience in manufacturing & marketing Anti Malarial formulations & 14 Formulations are being sold in over 30 countries. They are associated with WHO’s Roll Back Malaria Programme. Ipca is approved suppliers to UNICEF, WHO - Geneva, MSF-France and other Institutional bodies of repute. Ipca is India’s market leader with 32% market share of antimalarial drugs segment. December-2010

December-2010

AP’s Generic Outlook

India’s pharmaceutical industry is now the third largest in the world in terms of volume and 14th in terms of value. One reason for lower value share is the lower cost of drugs in India ranging from 5% to 50% less as compared to developed countries. According to data published by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, total turnover of India’s pharmaceuticals industry between September 2008 and September 2009 was $ 21.04 billion. Of this, the domestic market was worth $ 12.3 billion. According to an Ernst & Young and an industry body study released in September 2009, the increasing population of the higher income group in the country will by 2015 open a potential $ 8 billion market. Besides, the report said the domestic pharma market is likely to touch $ 20 billion by 2015, making India a lucrative destination for clinical trials for global giants. The accelerated growth over the years has been fueled by exports to more than 200 countries with a sizeable share in the advanced regulated markets of US and Western Europe. 40% of the world’s active ingredient requirement is met by India.

ANDHRA PRADESH IS ONE OF THE BIGGEST GENERIC DESTINATION IN THE COUNTRY THAT HAS GIVEN A GREAT PUSH TO THE INDIAN ECONOMY. THE GROWTH OVER THE YEARS HAS BEEN FUELED BY EXPORTS TO MORE THAN

200 COUNTRIES

WITH A SIZEABLE SHARE IN THE ADVANCED REGULATED MARKETS OF US AND WESTERN EUROPE. MORE THAN 40% OF THE WORLD’S ACTIVE INGREDIENT REQUIREMENT IS MET BY INDIA. 14

he pharmaceutical industry in Andhra Pradesh is one of the success stories of India ensuring that good quality essential drugs are made available at affordable prices to the vast population of the country as well as competing with some of the best names in the global markets. The industry is an intellectual industry and is in the front rank of India’s science-based industries with investment in research and development and wide ranging capabilities in the complex ﬁeld of drug manufacture and technology.

Pharmaceutical industry in India ranks very high in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously. The industry has made signiﬁcant progress in creation of required infrastructure, meeting global needs for supply of quality medicines and active pharmaceutical ingredients (APIs), as also entering into the highly opportune area of contract research and manufacturing (CRAM) and clinical trials. Export of pharmaceutical products from India showed a combined annual December-2010

growth rate (CAGR) of 21.25% during three consecutive years ending 2008-09 but grew only by 13% in 2009-10. India tops the world in exporting generic medicines worth of $ 11 billion. According to a report published by PricewaterhouseCoopers (PwC) in April 2010, India will join the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with the total value reaching $ 50 billion. The sector is estimated to have so far created 4.2 million employment opportunities with more than 20,000 registered units. Despite the fragmentation and price competition, the leading 250 pharmaceutical companies control 70% of the market with the leader holding nearly 7% of the market share. While pharmaceutical products are exported primarily to USA, Germany, Russia, UK and Brazil amongst a large basket of countries, India’s imports emanate mainly from China, Switzerland, USA and Italy. India currently exports drug intermediates, APIs, Finished Dosage Formulations (FDFs), biopharmaceuticals, clinical services to various parts of the world. The global market for contract manufacturing of prescription drugs is estimated to increase from a value of $ 26.2 billion to $43.9 billion. India could potentially capture 20% to 40% of the outsourced market share for active pharmaceutical ingredients, ﬁnished dosage formulations and intermediates. Frost and Sullivan estimates outsourced contract research in India to reach $ 2 billion by 2012. Similarly, according to a McKinsey report, the global clinical trial outsourcing to India in the pharmaceutical industry is estimated to be worth $ 1.23 billion. Over 15 prominent contract research organizations (CROs) are now operating in the country. Contract manufacturing is another new opportunity for the Indian pharmaceutical December-2010

industry. Already, India has the largest number of US Food and Drug Administration (US FDA) approved plants outside the US, with over 100 facilities. And now even small and medium scale pharmaceutical companies are setting up new and upgraded highquality manufacturing plants to take part in this growing segment. Established generic companies would like to outsource or buy services in formulation development, bio equivalence testing, stability studies centers, etc . India is signiﬁcantly ahead in chemistry services such as analog preparation, analytical chemistry, combinatorial chemistry, structural chemistry, structural drug design, computer aided drug design, high throughput screening and assay development.

Challenges Price sensitivities get tested in a crowded market where price tends to sag while volume business gets done. Competing pharmaceutical companies have several similar bio-equivalent products in the same market manufactured at facilities that have been approved by the highest regulatory authorities. All of them stay focused on the same markets with the result price elasticity is tested and margins get eroded. The challenges are greater from Indian manufacturers who have similar production facilities. It is also common to ﬁnd managers with similar talents and experiences in the industry. Indian manufacturers have made an impact on the global stage and have worked hard to get shelf space.

There are opportunities such as licensing deals with MNCs for New Chemical Entities and New Drug Delivery Systems, marketing alliances for MNC products in domestic and international markets and contract manufacturing arrangements with MNCs. There is enormous potential for developing India as a center for international clinical trials. The country can become a niche player in global pharmaceutical R&D and there are possibilities for expansion of bio-similars and bio-pharmaceuticals. 15

Ranbaxy

Trusted Global Brand DRIVEN BY THE PASSION OF IT’S AROUND 14,000 STRONG MULTICULTURAL WORKFORCE COMPRISING OF OVER 50 NATIONALITIES, R ANBAXY CONTINUES TO AGGRESSIVELY PURSUE ITS MISSION TO

RESEARCH-BASED INTERNAPHARMACEUTICAL COMPANY.

BECOME A TIONAL

ay back in 1961, when Ranbaxy Laboratories Limited (Ranbaxy) was set out on its way, little did anyone could have realized the impact it would make on the Indian and global pharmaceutical industry. Since its inception to till date, Ranbaxy is constantly delivering value to its stakeholders and inspiring its people to innovate, achieve excellence and set new global benchmarks. Today, the Pharma giant has grown into India’s largest pharmaceutical company and is tasting the fruits of its hard work gone in during the past 4 decades. Producing a wide range of quality, affordable generic medicines trusted by healthcare professionals and patients across geographies, the company has earned a brand name of its own and is renowned internationally as an integrated, research based, pharmaceutical company. Ranbaxy possesses the manufacturing strengths that have established it as a producer of world-class generics, branded generics and a major supplier of its range of Active Pharmaceutical Ingredients for pharmaceutical products across the globe. The company has made a mark in 23 of the top 25 pharmaceutical markets of the world. The Company has a global footprint in 46 countries, world-class manufacturing facilities in 7 countries and serves customers in over 125 countries. 16

Ranbaxy R & D Center, Gurgaon

Journey Incorporated in the year 1961, Ranbaxy has build a unique brand of its own kind over the past 4 decades. In the year 1973 Ranbaxy had gone for initial public offering (IPO) and attained Public Limited company status in 1794. In the same year a multipurpose chemical plant was set up for manufacturing APIs at Mohali (punjab). In the year 1978 the company formed its ﬁrst joint venture in Nigeria. A modern pharmaceutical plant at Dewas goes on stream in Madhya Pradesh in 1983. four years after in 1987 the company started production at the modern API plant at Toansa in Punjab. With this event Ranbaxy became India’s largest manufacturer of antibiotics/anti-bacterials. The Tansa plant got USFDA approval in the year 1988 which gave a great boost to its international drug trading. By the year 1993, Ranbaxy enunciated a corporate mission“To become a Research based International Pharmaceutical Company” and initiated

regional restructuring of international operations. By the end of 1994 the company developed state-of-theart New Research Center at Gurgaon (near Delhi), which became fully operational. Another major milestone was achieved when Ranbaxy acquired Ohm Laboratories Inc., a manufacturing facility in USA in the year 1995. In the year 1997, Ranbaxy achieved record sales turnover of Rs 1000 crores with exports over Rs 500 crores. The company launched its ﬁrst product in 1998 under Ranbaxy label introduced in the US market, the world’s largest pharmaceutical market. Ranbaxy out licensed Ciproﬂoxacin OD, it’s original NDDS research product to Bayer AG Germany during the year 1999. In 2000 Ranbaxy entered Brazil, the largest pharmaceutical market in South America and acquired Bayer’s Generic business, Basics, in Germany. After 3 years Ranbaxy & GSK enter into a global alliance for drug discovery & development and it also December-2010

entered into collaborative research with ‘Medicines for Malaria Venture’ (MMV), Geneva, for development of Anti-Malaria Drug and Joined hands with Clinton Foundation on drugs for HIV/AIDS. In 2004 Ranbaxy’s global sales crossed $1 billion and joined the elite club of billion dollar companies in the world. It commissioned its new state of the art manufacturing facility in Malaysia sdn Bhd (RMSB) in the year 2005. In the same year, World Health Organization, Geneva, included Ranbaxy’s seven ARVs in its pre-qualification list. With the establishement of its wholly owned subsidiary, Ranbaxy entered the Canadian Healthcare system. In 2006 Ranbaxy acquired leading Romanian Pharma company, Terapia and 5th largest South African generics company called Be-Tabs pharmaceuticals. It also entered into an agreement with community Investment Holdings (CIH), South Africa, to form JV christened “Sonke Pharmaceuticals (Pty) Ltd” to market ARV medicines. In the year 2007, Ranbaxy’s Drug Discovery Team achieves significant milestone in GSK research collaboration–with the candidate selection of a compound for Respiratory inflammation. The company acquired 13 brands from Bristol Myers Squibb to expand its presence in the US Dermatology Market during the same year. In June 2008, Ranbaxy entered into an alliance with one of the largest Japanese innovator companies, Daiichi Sankyo Company Ltd., to create an innovator and generic pharmaceutical powerhouse. The combined entity now ranks among the top 20 pharmaceutical companies, globally. The transformational deal will place Ranbaxy in a higher growth trajectory and it will emerge stronger in terms of its global reach and in its capabilities in drug development and manufacturing. In the year 2009 Ranbaxy launched DS innovative hypertensive, Olvance (Olmesartan) December-2010

in India. It also commenced Phase III studies on its novel anti-malaria drug, Arterolane Maleate + Piperaquine Phosphate in India and South East Asia and launched DS product Evista in Romania and also sets up a new division in Mexico to speciﬁcally market DS products. Recently in 2010, Ranbaxy launched its project VirAAT in India. The company is aiming for the No. 1 position in the Indian Pharmaceutical market by 2012. For the ﬁrst time in the history, Ranbaxy delivered quarterly sales of over $ 500 million. It has also entered in to its Golden Jubilee Year on 16th June 2010, 50 years of an inspiring, pioneering and historic journey.

Financials For the year 2009, the Company recorded Global Sales of US $ 1519 Mn. The Company has a balanced mix of revenues from emerging and developed markets that contribute 54% and 39% respectively. In 2009, North America, the Company’s largest market contributed sales of US $ 397 Mn, followed by Europe garnering US $ 269 Mn and Asia clocking sales of around US $ 441 Mn.

Strategy Ranbaxy is focused on increasing the momentum in the generics business in its key markets through organic and inorganic growth routes. Growth is well spread across geographies with focus on developed and emerging markets. It is the Company’s constant endeavour to provide a wide basket of generic and innovator products, leveraging the unique Hybrid Business Model with Daiichi Sankyo. The Company will also increasingly focus in high growth potential segments like Vaccines and Biogenerics. These new areas will add signiﬁcant depth to the existing product pipeline.

R&D Ranbaxy views its R&D capabilities as a vital component of its business strategy that will provide a sustainable, long-term competitive advan-

tage. The Company has a pool of over 1,200 R&D personnel engaged in path-breaking research. Ranbaxy is among the few Indian pharmaceutical companies in India to have started its research program in the late 70’s, in support of its global ambitions. A first-of-its-kind world class R&D center was commissioned in 1994. Today, the Company has multi-disciplinary R&D centers at Gurgaon, in India, with dedicated facilities for generics research and innovative research. The R&D environment reflects its commitment to be a leader in the generics space offering value added formulations and development of NDA/ANDAs, based on its Novel Drug Delivery System (NDDS) research capability. Ranbaxy’s first significant international success using the NDDS technology platform came in September 1999, when the Company outlicensed its first once-a-day formulation to a multinational company. In July 2010, Ranbaxy’s New Drug Discovery Research (NDDR) was transferred to Daiichi Sankyo India Pharma Private Limited as part of the strategy to strengthen the global Research and Development structure of the Daiichi Sankyo Group. While NDDR will now become an integral part of Daiichi Sankyo Life Science Research Center in India, based in Gurgaon, Ranbaxy will continue to independently develop and later commercialise the anti-malarial new drug, Arterolane + PQP, which is currently in Phase III trials. Ranbaxy will also explore the further development of late stage programs developed by NDDR in the last few years, including the development programs in the GSK collaboration. Within Ranbaxy, R&D of Generics will get a sharper focus, as the Company is increasingly working on more complex and specialist areas.

Aurobindo

Wellness on the rise ONE OF ASIA’S FASTEST GROWING PHARMACEUTICAL COMPANIES; AUROBINDO PHARMA LIMITED IS POISED TO CLOCK A TURNOVER OF $1 BILLION BY THE END OF THE CURRENT FINANCIAL YEAR. THEIR TARGET FOR 2014 IS TO CROSS $ 2 BILLION. AND, WITHIN THE NEXT FIVE YEARS, APL IS CONFIDENT OF BEING ONE THE TOP FIFTEEN GENERIC PHARMACEUTICAL COMPANIES OF THE WORLD.

wenty years ago, APL started operations with a single unit in Pondicherry, manufacturing Semi-Synthetic Penicillin (SSPs). Today the company has vertically integrated its operations to offer a diverse portfolio of more than 300 products in key therapeutics: cardiovascular, neurological, gastroenterological, anti-diabetics, anti-retrovirals, antibiotics and anti-allergics.

‘marketable products’ to create multiple streams of business. This model has helped us enter into partnerships with some of the biggest multinational companies of the world, allowing us to market these products in over 100 countries ourselves”. With the expiry of patent protection and the chances of new molecules hitting the market bleak, APL was quick to seize the opportunities offered by generics. Leveraging on its vast experience in IPR (intellectual property rights), manufacturing capabilities, customized R&D services, total Quality management and a supply line that cuts both time and costs; APL is successfully entering into strategic partnerships with Global Pharma Giants for licensing and long term supply of products to both generics and branded markets in US, Europe, Australia, New Zealand and Canada.

However, the company already has a formidable global market presence in over 120 countries. With 8000 employees, over 700 scientists, operations in 34 countries and manufacturing facilities across 4 continents, it is small wonder that APL is among the top ﬁve Indian pharmaceutical companies, in terms of exports and revenue. The company exports to over 125 countries and generates more than 70 percent of its revenues from international operations. Excellent performance in formulation exports won APL the “Outstanding Export Performance Award” in 2009 from Pharmaceuticals Export Promotion Council of India (Pharmexil) set up by Ministry of Commerce and Industry. Though a new entrant, APL gained a critical mass in the US market with the commercialization of its new products

These products are manufactured in one of its 15 state-of-the-art manufacturing plants across the world, which are approved by USFDA, UKMHRA, WHO, MCC-South Africa, ANVISA-Brazil, TGA- Australia, for both APIs and Formulations. But driving APL’s meteoric rise is its strong pipeline of ANDAs (Abbreviated New drug Applications), DMFs (Drug Master Files) for APIs and dossiers for generic formulations; filed in US, Europe and the Rest of the world. This forms the basis of APL’s unique business model. It takes advantage of the expanding market potential of branded generics as many patents expire this year. Mr. K. Nithyananda Reddy, Managing Director, APL explains, “we have filed a large number of filings around the world and converted them into 18

K Nithyananda Reddy, MD, APL December-2010

and the growing market share of its launched products. It has successfully established a strong network of distribution channels through strategic selection of wholesalers, warehouse chains, retailers and mail orders. In US it has developed and filed more than 185 ANDAs, out of which 126 products have been approved by the USFDA as on 30th September 2010, making it one of the fastest growing Pharmaceutical companies in the world’s largest Pharmaceutical market. The company has begun operations at its manufacturing facility in New Jersey. The plant along with catering to local markets through institutional sales and will also manufacture controlled substance products. APL hopes to deepen its European footprint by building on various marketing agreements with local distribution networks. The company is boosting its formulations distributions pan Europe, through Malta in dossier licensing operations, Quality Control/ Quality Assurance, Packaging and centralized warehousing. Along with expanding its global footprint, APL continues to capture a large portfolio of product approvals with focused R&D efforts to develop intellectual properties in resolving complex chemistry challenges, improving process efficiencies and developing bio-equivalents. The company’s technological expertise in complex chemistry, product development and bio-studies gives it an edge in developing formulations for sustained release, fixed dose combination products, pediatrics and sterile injectables. The company’s R&D assets have ensured it repeatedly emerged as a major player in regulated markets for lifestyle disease drugs and sterile and non-sterile cephalosporins. APL has till date filed over 185 ANDAs, 151 DMFs and 450 patents. ”These filings were in turn a result of our huge investments on R&D, manufacturing, December-2010

IPR and Regulatory affairs”, agrees Mr. K. Nithyananda Reddy. It’s a small wonder then that APL’s formulations business grew to $500 million in seven years. APL is also a strong player in the niche market of ARVs (Anti-retrovirals) with a vast offering of combination and pediatric products. APL has actively and successfully participated in global tenders ﬂoated by PEPFAR (President’s Emergency Plan for Aids Relief), Clinton Foundation, WHO and various other country speciﬁc agencies. Injectable Drugs is another high growth market being tapped by APL. With dedicated Cephs and SSPs Injectable plants, APL has a strong hold over this segment. Recently, APL acquired a non-betalactum high value injectable plant from Trident Life Sciences Limited. The facility specializes in manufacture of general injectable

range of formulation products including glass vials for lyophilized sterile powder, ampoules, pre-ﬁlled syringes and blow-ﬁlled seals. This acquisition further enhances APL’s capacity to offer comprehensive Pharma manufacturing, distribution, and customized services and solutions to tits clients.

to the potential growth in generic market”. A lesser known fact aiding APL’s scorching growth is its incredible in-house “Project Management Skills” which have helped it build an efﬁcient world-class and world-scale infrastructure in a relatively short period of time. For instance, the company’s formulation facility at Jadcherla SEZ has been commercialized.

AuroSource Through AuroSource, APL offers the global biotech and pharmaceutical community, a refreshing approach to outsourcing. A service oriented, customer centric division of APL, AuroSource will provide custom R&D and Manufacturing services (CRAMS) for large, mid-sized, emerging biotech and pharmaceutical entities globally. AuroSource will facilitate faster product development while optimizing costs by reducing the time between drug discovery, development and its subsequent entry into the market. It will also partner the with innovator company to research, manufacture and develop compounds across the entire drug lifecycle. Its division based in Hyderabad is uniquely poised to deliver Customized manufacturing solutions for APIs, intermediates, Pre-formulations and formulations across each stage of the drug life cycle

Giving details of the company’s ongoing expansion plans, K. Nithyananda Reddy said, “The major capex phase of the company is over as we have already built a huge capacity to cater 19

Regulatory, research and development expertise from pre-clinical to post patent expiry stage in drug development Premium solutions for product life cycle management including life cycle extensions and line extensions This is a huge opportunity for suppliers and contract manufacturers of pharmaceutical products. The AuroSource team has a distinct advantage over others as APL has already commercialized more than 200 API’s and 120 ﬁnished drug Products making it an ideal contract service provider.

Oral contraceptives and Penams APL’s aims to secure a prominent position among the top 5 generic players in the world within the next ﬁve years. In pursuit of this goal, APL plans to ﬁle more ANDAs, pursue

licensing partnerships with more Multinational companies, and aggressively expand their CRAMS business. The company is also investing in two new niche business segments to accelerate its momentum of growth. APL is set to enter the Oral Contraceptives segment with a 40 crore rupees self contained production facility located in the SEZ near Jadchela, about 60 kms from Hyderabad Airport. The company plans to market in regulated markets, their ﬁrst target is Japan. APL has also begun constructing a Generic formulation Manufacturing Unit with a dedicated APIsterile block at Bhiwadi, about 70 kms from Delhi, to produce fourth generation high-end antibiotics called Penams. The Penam product range will include Imipenam and Mereopenam in Powder Injectables dosage forms in vials. The products will be initially marketed in domestic and emerging export markets.

The project is expected to commence by 3rd quarter FY11. It will be manned by 50 personnel. An additional investment of 35 crores rupees is being funded through internal accruals. APL further plans to enter the Canadian market by the end of this year. Health Canada, a public health department of Canadian government, is expected to approve at least 25 of the 80 products; the company has ﬁled for approval. “So far, Health Canada has approved 12 of our products. We want to have a basket of at least 25 approved products to launch our operations in Canada”, adds the Managing Director.

Fiscal fitness The company is confident of its fiscal performance and is certain of overcoming any short falls, with its strong balance sheet. By the next year, APL would not have any significant borrowings other than its normal working capital loan. All outstanding FCCBs (Foreign Currency Convertible Bonds) would be either converted into stocks or redeemed. The company’s current FCCBs stand at $160 million in 3 tranches. The first tranche of FCCB stands converted. The company has bought back $ 62 million of the other tranches. The other tranches are either in money or will mature by the next year. December-2010

Natco

Indian Global Player REALIZING R&D AS ITS CORE STRENGTH, NATCO HAS VENTURED INTO DRUG DISCOVERY AND IS PROVED

3 IMPORTANT ONCOLOGY MOLECULES. ROOTED WELL IN THE DOMESTIC MARKET, THE PHARMA GIANT IS EXPANDING ITS GLOBAL MARKETS AND EARNING MORE THAN 25 SUCCESSFUL IN DISCOVERING

PERCENT REVENUES FROM EXPORT ARENA EVERY YEAR.

ased in Hyderabad NATCO Pharma Limited is one of the fastest growing integrated pharmaceutical companies in India and is characterized by its pre-eminence in Research. Guided by its vision to provide affordable medicare to humanity, NATCO, started about 26 years back as a simple formulations unit, with an investment of about Rs. 12 lakhs - is now a conglomerate of six manufacturing units (two of them having several international accreditions including that of US FDA) and employs more than 2000 personnel.

tor multi-national companies and in fact, has launched generic versions of certain products for the ﬁrst time in the World. The R & D skills of the company and its pricing policies have earned the company several awards, including one for best R & D efforts by the Government of India. Taking its core strengths of R & D a step further, NATCO has ventured into drug discovery and is currently working on three oncology molecules which are very promising. One of the molecules has already undergone the Phase I clinical trials and is ready for Phase II clinical trials. These molecules, when developed, would prove to be a boon for millions of patients suffering from different types of cancers. The R & D teams have been responsible for developing drugs based on novel technologies such as – nano-

technology platform, (such as albumin bound paclitaxel)and cracking most complex technologies such as those involved in Capoxane® (Glatiramer Acetate). As a result, NATCO has been able to develop generic versions of important molecules such as Revlimid® (Lenalidomide), Pravacid® (Lansaprazole) etc. NATCO’s technical abilities have attracted several multi-nationals such as Mylan Inc., Actavis, Watson Pharmaceuticals, Lupin Limited, Dr. Reddy’s Laboratories Limited etc.to it for tie-ups. NATCO has been successfully able to negotiate valuable arrangements with these companies which facilitate marketing of NATCO’s products all over the world. In respect of Lenalidomide – which has a global market of over US $ 2 Billion, and growing at over 40% every year – NATCO is

Credited with the introduction of sustained / delayed – release technology to India during the late 1980s, NATCO has entered into the niche oncology area during 2003 and has ever since, consistently recorded a growth rate of over 25 per cent every year and is now ranked number one company in terms of revenues, among all the domestic pharmaceutical companies in the oncology space. In India NATCO has taken up the responsibility of providing third generation oncology drugs to the suffering millions. Known for its aggressive pricing policies, oriented towards the patients, NATCO has been making available lifesaving drugs at a fraction of the price charged by the innova22

P. Bhaskara Narayana, CFO, Natco December-2010

likely to get 180 days exclusivity in four different strengths. This would straight away catapult NATCO in to big league. NATCO has been able to achieve efﬁciencies of scale and cost effectiveness owing to its vertical integration. For most of its premier oncology products, the raw material is made by NATCO itself, giving it an enviable and un-matched price advantage. Thanks to the vision of the promoters’, NATCO has always been in the forefront of technology and strategic planning. NATCO has always been and continues to believe in quality and this has enabled the Company to undertake contract manufacturing for several well-known pharmaceutical companies such as Ranbaxy Laboratories Limited, Dr. Reddy’s Laboratories

December-2010

Limited, Wyeth Limited, gsk Pharmaceuticals etc. These companies get their products meant for exports manufactured at NATCO’s state of the art, world class facilities. NATCO’s manufacturing facilities are constantly upgraded to comply with international standards. NATCO’s manufacturing facility for active pharmaceutical ingredients is a zero discharge facility with ISO:14001 certiﬁcation for its environmental management systems. Giving more insights about NATCO’s export earnings, Mr. Bhaskara Narayana, CFO, NATCO, says “ More than 25% of revenue comes from exports, which accounts to $ 125 Million per annum.” NATCO’s contribution towards the state exchequer in terms of taxes is also quite signiﬁcant.

NATCO values its human resources as its biggest asset and attempts to provide equal opportunities for growth for all its employees. Freedom to operate within one’s own sphere of responsibility results in excellent output and brings out the best in the human resources. NATCO believes in constant and continuous up-gradation of knowledge based skills and encourages its employees in the learning process. Employees are trained from time to time in latest technologies, skills and team-building exercises. NATCO has been on the dividend list for the past ﬁve years and believes in a reasonable pay-out ratio towards its shareholders. The price of NATCO’s share on the stock markets is a reﬂection of the inherent value of the Company.

Caliber

QUALITY COMPLIER AN UNTAPPED NICHE AND A GLOBAL OPPORTUNITY, FAITH IN THE CONCEPT AND CONFIDENCE IN THE TEAM ARE THE DRIVERS FOR THE GENESIS OF

CALIBER

TECHNOLOGIES. THE IDENTIFIED NICHE IS PHARMA/BIOTECH INDUSTRY AND THE PRODUCT IS LIMS (LABORATORY INFORMATION MANAGEMENT SYSTEM) WITH ITS EXCLUSIVE C ALIBER BRAND.

oday Caliber has proved its caliber by emerging as a clear market leader in India and a recognized global player in its own right, with ofﬁces in India and USA. Caliber has just entered its tenth year and on the eve of its successful decade celebrations, Caliber is emerging as a knowledge center for Pharma IT management practices. Caliber has won coveted awards in the industry that stand as testimonials to its achievements, including HYSEA Award in the best product category, Deloitte India’s Fast 50 companies, Deloitte Asia’s fast 500 companies, Hyderabad Management Association award for best SME entrepreneur etc. But the best testimonials to Caliber remain the continued patronage and support of its esteemed and valued customers.

stringent quality requirements mandated the necessity for integration between quality systems and enterprise resource systems. It is no longer acceptable to maintain islands of information in areas that impact heavily on each other. Keeping this in view, Caliber Technologies has visualized the need for a comprehensive Laboratory software like LIMS a decade ago, that would seamlessly integrate with other enterprise applications to have uninterrupted information flow. Today Caliber’s flagship product, CaliberLIMS, has become central and crucial for exclusive and secure laboratory data management in the Pharma and Biotechnology industry. CaliberLIMS flagship product has been assisting pharma companies to reduce the risk of regulatory non-compliance for nearly a decade now!

markets, Caliber has become a leader in providing Laboratory Information Management Systems with more than 3500 satisﬁed hands-on users and many multi site installations across the world. The company enjoys more than 85 percent market share in India, with a considerable presence in other world markets. “Being vendors to the pharma companies has its own share of challenges. Stringent adherence to the quality systems in our day to day process is a minimum requirement. Change management, documentation, personnel training are an important part of our operations. These practices have helped us in successfully clearing vendor audits by large MNCs and other certiﬁcations”, says Bhaskara Phanikar, who heads the Quality Management and Validation Practices team.

With its products being used both in the domestic and international

Adding to what has been said, Rajasekhar Gollapinni, heading the Global

The journey Since its inception in the year 2001, Caliber Technologies has been focused towards delivering specialized solutions for the Pharma and Biotech sector across the globe. With a vision to excel in our domain, Caliber designed its products ground up to meet the regulatory expectations by leveraging with cutting edge technology. In the bio-tech, pharmaceutical and petro-chemical industries, increasing demands on production coupled with 24

Sathya Sekhar Surabhi, Managing Director, Caliber Technologies December-2010

Product Delivery, says, “Through constant ﬁne-tuning of our delivery practices, we have considerably reduced the application deployment time from 18-24 months of industry standards earlier, to 6-8 months now. This has helped us not only in 100% customer retention but also in replacing some of the leading brands with our product”

poration Ltd. (BPCL’s) quality initiative program, ‘Pure for sure’, which monitors quality of petroleum products through the entire supply chain and manages market complaints redressal across India through CaliberLIMS. It is no surprise that this project won the national and international awards for best IT deployment”.

Quality-A way of life at Caliber

Caliber’s strong and committed team is the strength and secret of its success. Caliber’s positive HR policies

Quality has been more of a passion for Caliberians. Solutions designed for Pharma are of a different breed, where software code is just one piece of the puzzle and other pieces like implementation, validation, validation state management and training are some of the key components of the solution.

Team Caliber

Ravi Kumar Annamraj who heads the Technology Application Group (TAG), a special focus team for new product development.

Value Proposition The Caliber Product Suite, including new CaliberBRM (the Electronic Batch Records Management System), launched in November 2010, helps a regulated industry enterprise achieve business results faster by revolutionizing the way its lab and batch manufacturing processes are conducted,

Caliber created special focused teams for each of the so called puzzles, to master the solution delivery. Software products from Caliber are mostly categorized as Critical Applications in Pharma industry. It needs a greater understanding of the pharma practices and International regulatory expectations to have successful implementations and Caliberians have this understanding. The Caliber team’s competency to design and deliver a total solution to the industry has been the key success factor in becoming quality partners for a majority of Pharma companies worldwide. Sekhar Surabhi, CEO of Caliber says, “We have been chosen as quality partners by many leading pharmaceutical companies because of the immense value our products and services add to their processes. Very often, our products help our customers to sail through the stringent regulatory audits with ease. Appreciations that our team gets on such occasions from our dear customers is our adrenaline. We are delighted to have our CaliberLIMS as the backbone of Bharat Petroleum CorDecember-2010

Team of Caliber Technologies

lay a strong foundation to build a team which is highly customer centric. Talking about the team Ms. Aparna, HR says, “Our team has diverse talents to achieve our vision of becoming global leaders in our ﬁeld. Our team is uniquely structured to have high core competency within the group to collectively deliver total solution to the customer with great commitment.” “Right design is the best beginning one can make towards a robust product. All our products are designed groundup for meeting the regulatory requirements of highest standards. Our job is to ensure that the products are scalable, userfriendly and easy to maintain. With that focus we are able to deliver signiﬁcantly lower cost of ownership to our customers”, says

improves business processes and their accountability, offers instrument connectivity and ERP integration for effective Enterprise Quality Management and regulatory compliance. Caliber has conceptualized the fusion of pharma manufacturing and analytical processes, regulatory requirements and technology to come up with invaluable software solutions for the pharma and biotech industry ensuring enriched features, fast delivery, demonstrable security, quick turnaround time, cost efﬁciency and many more advantages. Elaborating on Caliber’s IT solutions, Sekhar Surabhi, says, “In addition to our highly successful Laboratory Information Management System, Cali25

berLIMS, we have products that make the quality management a wholesome affair. Our latest integrated Caliber Application Portal (CAP) consolidates our various key applications to create a single sign-on application, so that companies can use various applications like LIMS, Quality Assurance Management, Electronic Batch Records Management and Enterprise Document Management, seamlessly. We have progressed from a Lab Management solutions company to a Quality Management Solutions company where our solutions encompass many segments of an enterprise”.

surance and Information Management in a Pharma and Biotech Industry. In addition to CaliberLIMS which has variants for regulated industries like Pharma, Oil and Gas, Lubricants, Water etc., its other solutions include: Caliber BRM (Electronic Batch Records Management) Caliber DMS (Enterprise Document Management System) Caliber QAMS (Quality Assurance Management System)

and user friendliness thereby propelling the Caliber Product Suite into the next generation. The ﬂexible multitier architecture is designed to eliminate periodic re-investments and loss of data experienced during upgrades and enhancements. The independence and separation of the client, application layer, and database components facilitates a partition of ongoing development and maintenance tasks. As a result, Caliber products always deliver an unparal-

leled performance when compared to client/server architecture.

Center of Excellence.. a Decade of Initiative

He further adds, “CaliberLIMS is built on a robust architecture to facilitate seamless integration with other applications through various layers of communication. The rich web services availability makes it easier, quicker and more secure to integrate with other specialized applications. Caliber’s collaborative approach with other application vendors adds more value.”

Products and Service offerings Caliber is the only software company that provides proven products in all the key processes for Quality As26

Nichelon5 Enterprise training management as GMP Caliber is an implementation partner for Nichelon5 CMS, a Competency Management and Enterprise Training Management System, for complete training lifecycle management that addresses all the 21 CFR Part 11 compliant GMP Training in SOP requirements.

Future-Proof Technology & Performance Caliber products are built with a true n-tier (5 tier) web architecture on the Microsoft ASP.net platform for better referential data integrity

Well trained and intellectual workforce is of utmost importance for knowledge management in a software solutions company. Caliber is in the process of building a center of excellence for Lab Informatics. “We are developing a Center of Excellence for Lab informatics which will be the ﬁrst of its kind in the country. This center will have a state of the art training center to provide training to the industry in lab informatics and regulatory standards in managing software applications in critical operations. As a part of corporate social responsibility, Caliber believes in giving back to the community and create the desired eco system for the industry to ﬂourish.” added Mr. Sekhar.

December-2010

Timetech

Dedicated to NDDS A PIONEER OF NEW DRUG DELIVERY SYSTEM, TIMETECH FORMULATIONS LIMITED HAS EVOLVED OVER THE YEARS AND ESTABLISHED A STRONG GROUND IN THE INNOVATIVE DELIVERY AND TIMEDRELEASE FORMULATIONS THAT HAVE PROPELLED IT TOWARDS SUSTAINING A COMPETITIVE PROMINENT PLACE IN THE COMPETITIVE MARKET.

ith a humble beginning in 1996, Time Tech formulations has focused on a novel drug delivery systems and specialized in sustained time-released technology which reduces the cost of medication and frequency of dose besides minimizing side effects. Headquarter in Hyderabad, Timetech formulations limited is a trendsetter in pharma circles. A fore runner in new drug delivery pellets technology and various timed-release formulations, it produces a wide range of products that include Non betalactum, anti allergic, anti-ulcerative, diabetic care, cardio protective, anti rheumatic range and many more. “since we are experts in the line of NDDS, we plan not to deviate from our area of expertise. in other words we strive to further evolve the concept of NDDS” said, G. N. Raju, Managing Director, Time Tech Formulations. Over the years, the company has acquired a well equipped state-of-art manufacturing facility in Bolaram with a built in area of 80,000 SFT. This unit meets all regulatory norms to manufacture the products of various dosage forms to cater to domestic and overseas markets. Today, Timetech is all set to deliver fully integrated drug delivery system solutions, including formulations and development 28

studies, product registration and manufacturing. The company complies with all WHO-GMP standards, ISO-2008 certification, CRISSIL rating and all regulatory aspects for exports with well established R&D with high capacities to produce pellets, tablets, capsules, DC granules, and sachets. “We are equipped with independent modules meeting all regulatory norms. Novel Drug Delivery System (NDDS) with its efficacious solutions is providing the panacea for qualitative medicines. Through better understanding of pharmacokinetics and low toxicity, NDDS has now come to be recognized for safe and effective delivery of drugs.” said Mr. Raju. He further adds “The NDDS renders the patients increased efficacy, simplicity, safety and better patient compliance. For the health care pro-

viders this system improves the cost effectiveness of drugs and treatment. When compared with multi dosing preparations, the cost effectiveness would be considerable.” The NDDS is highly beneﬁcial for patients It helps in minimizing the side effects, and also capable of preventing high localized concentration of drugs thus minimizing gastric irritation, it enhances patient compliance by avoiding multi dosing. By maintaining the well balanced serum levels of the drug for longer duration, the NDDS helps for better management of the disease condition. The company’s timed-release pellets and formulations are exported to various countries With its main focus on export markets Timetech is making its presence felt among the equals Timetech is continuing its efforts to develop newer molecules under

G. N. Raju, Managing Director, Time Tech Formulations December-2010

of individuals and stringent methods of quality checks at different levels helped us reach greater heights.

FUTURE PLANS

NDDS. Moving with a clear plan the company has developed a well-established R&D facility with qualiﬁed technocrats for drug development procedures and employed an able marketing team for selling the products in Indian and overseas markets.

December-2010

Timetech owns its grand success to well experienced, qualiﬁed, committed and loyal technocrats, good team work with conscious and continuous effort to upgrade knowledge and technology. Quality consciousness

As a part of its future plans, Time tech is marching ahead with research and development. Timetech believes that pharma is an evergreen industry with a huge potential of untapped market. “We strive to maintain the high level of quality and regulatory standards. Market monopoly is our ambition by way of developing and producing unique products in different dosage forms. Offering lower cost options to patients is always the dictum. All these years we have been sailing smooth due to our strong hold on the pharma markets,” said Raju.

IICT

Decades of Excellence WITH OVER 450 HIGHLY PROFESSIONAL AND DEDICATED SCIENTISTS AND TECHNICAL OFFICERS/TECHNICIANS, EXCELLENT LABORATORY AND INSTRUMENT FACILITIES

IICT IS KNOWN NATIONALLY AS WELL AS INTERNATIONALLY FOR ITS CONTRIBUTIONS BOTH IN BASIC AND APPLIED RESEARCH.

MORE THAN 150 TECHNOLOGIES DEVELOPED ARE NOW IN COMMERCIAL PRODUCTION. ITS COMMITMENT TO INDUSTRY IS REFLECTED BY ITS EXTER-

2010 WHICH IS EXPECTED TO REACH RS. 30 -32 CRORES. NAL CASH FLOW FOR THE YEAR

tanding tall on the strength of its expertise, Indian Institute of Chemical Technology (IICT) is poised to assume leadership role in the development of New Drug and Drug delivery system, besides generic drugs. Rooted its base more than 6

Dr. J S Yadav, Director, IICT 30

decades in the per-independent India, today IICT Hyderabad has grown in to a premier R&D Institute in the country. The Institute had its origin as the Central Laboratories for Scientiﬁc & Industrial Research (CLSIR), established in 1944 by the then Government of Hyderabad State. After integration of Hyderabad State with the Indian Union, the laboratory expanded with its growing activities.

energy etc. IICT is right at the top in terms of publications, patents, impact factor and several other performance measures compared to the other chemical research laboratories and academic institutions. More than 150 Technologies developed by IICT are now in commercial production. The core strength of IICT lies in Organic Chemistry, and it continues to excel in this ﬁeld for over six decades.

Realizing the importance of having an indigenous Chemical research institution to cater the medical and biological needs of the country, Pandit Jawaharlal Nehru, the founder Prime Minister of India, had established IICT and helped it evolve in all aspects after Independence. Since then, IICT has grown as a premier research institute of India, and pioneered several innovative process technologies in diverse areas such as Drugs, Agrochemicals, food, specialty chemicals, adhesives,

Since inception, IICT has enabled several cost effective process technologies for generic drugs and made available to industry. These include for antiemetic diltiazem for coronary heart disease, ketotifen and cetrazene for antihistamine, tamoxifen for breast cancer etc., these developments enable drugs manufactureres to make available these drugs at affordable price to the common man. Dr. Yadav, Director, IICT is an eminent scholar and a lead scientist well known across the globe. Under his able guidance IICT is able to successfully carry out extensive basic and applied research investigations in the synthesis of complex Natural products of biological relevance in just a span of two and half decades of research career. A specialist in asymmetric synthesis to create new chiral centers in complex organic molecules and utilize them effectively in synthesis of many bioactive molecules such as, Hydroxy fatty acid, Discodermalice, Rifamycin, Scytophycin, Calcimycin, Artemisin, Taxol etc. Dr Yadav’s research group has successfully developed cost effective Technologies for special chemicals like Diltiazem, Ondaseyron, Pyrazinamide, Ketotifen, Meﬂoqauin, Tamoxifen etc., which have been very well received by the domestic and Overseas drug industries. The global majors like Smithkline Beecham December-2010

(SB),Dupont, FMC and Ranbaxy, Lupin and Dabur have entered into medium term contract research agreement with his research teams. His research findings have been published in more than 726 research papers. Elborating on the IICTs role in chemical and biological research, Dr. Yadav says, “IICT’s core competencies are new bioactive molecules for drug applications. We are working on Herbal drug and standardization and carrying on studies for lead optimization and structure activity relationship. So far we have come out with potential leads like anticaner, antidiabetic, anti-inflammatory, anti-fungal and memory enhancer (alziemer’s) which have been actively utilized for final drug manufacturing by leading pharmacy companies.” He further adds “our future plan is to establish state of the art facilities for natural product isolation and combinatorial synthesis. We are working towards isolating bioactives from medicinal plants and generate combinatorial libraries across the active NP backbones. We are also planning to establish automated storage and retrieval system capable of storing 5 million compounds.” Building on its core competence IICT has made forays into drug discovery and delivery systems. “we at IICT have synthesized several new molecules for screening against different targets. The lead molecules thus identified are then transferred to industry for further development to industry. Terminal diseases, like cancer is given special attention and several programs are underway for development of new chemical entities as anti cancer therapeutics. Some of these synthetic compounds exhibited different pharmacological properties including anti ulcer. Work is also underway towards the development of diagnostic and target based molecular medicines against allergy, bronchial asthma and chronic obstructive pulmonary diseases” says Ms. Manika, Senior scientist, IICT. December-2010

Other important area of IICT includes the synthesis of nano materials suitable for nano biotechnology applications. Dr. Manorama, Senior scientist, IICT says, “we have developed a methodology to encapsulate biologically active molecules in silica nonoparticle microcapsules for its use as drug delivery agents. Mono layers-protected colloidal nanopar-

in human causes genetic mutations which in turn effects adversely on the cell division and causes cancer. Therefore an effective way to combat human diseases is to silence such gene expressions. RNA1 therapeutics has taken a lead role in identifying an active target sequence. But the key challenge is to ensure efﬁcient delivery of small interfering RNAs

ticles provide a versatile scaffold tor protein surface recognition.” IICT is in the process of developing TiO2 nanocomposites based monolayers for protein binding and separation for use as scaffolds for bone and tissu2e engineering.

insides the cell cytoplasm. “we at IICT are working on this area and designing lipid based transfection vectors for packaging and target speciﬁc delivery of small RNA” said Dr. Manika.

Biotech Incubation center Incubation Center is a great idea to help enthusiastic entrepreneurs take up their research and then gradually establish their own industry. This will also help accelerate the commercialization of new technologies. Keeping this in view IICT has established a Biotechnology Incubation Centre (BTIC) in the genome valley. BTIC, the ﬁrst of its kind in India, nurtures and mentors emerging ventures in the biotechnology area and assists new enterprises to forge appropriate linkages with other biotech companies, academia and government.

RNA1 Therapeutics to contain Cancer The undesired gene expression

R & D facilities IICT is well equipped with world class for chemical and biological research in the country. For screening of new chemical entities, IICT is building a dedicated Chemical Biology facility where target based biochemical screens and cell-based screens will be conducted. In the ﬁrst phase the institute is setting up facilities in the areas of diabetes, cancer, cardiovascular disease and CNS disorders. These would be expanded in phase to cover other disease areas. IICT is also establishing a mol-bank store for synthesised chemical entities. “The primary objective of these facilities is to develop primary leads and further develop into lead molecules in association with industry”, said Dr. J.S. Yadav, Director IICT. 31

Sipra Labs

Research with Passion INITIALLY, BEGAN AS AN ANALYTICAL LAB IN 1994, SIPRA L ABS HAS STRIDDEN PAST 16 LONG YEARS, GRADUALLY CLIMBING THE GROWTH LADDER. TODAY IT HAS BECOME A FULL-FLEDGED RESEARCH FIRM TO PROVIDE ONE-STOP RESEARCH SOLUTIONS TO THE DRUGS& PHARMACEUTICAL INDUSTRY.

ocated in Hyderabad, Sipra Labs is one of best examples of quality research centers in the country. It has built a state-of-art facility with an exclusive center meant for research and testing of food and pharmaceuticals samples. In fact, Sipra Labs has expanded the facility from an initial area of 4000 sq ft to 165,000 sq ft to accommodate its increasing portfolio of services. Today it is one of the world class centers in the country, highly equipped to provide a range of testing solutions. Commencing operations at its new center in 2009, the company is all set to expand its domestic services and tap opportunities in the export segment as well. On the whole, it is a one-stop-shop for a variety of Food and Pharmaceutical Research and Testing in the country. Over the years, Sipra Labs has come a long way, providing serves for formulations development, technical dossiers, clinical trials, bioequivalence studies and analytical method development validations. Recognised for its quality, Sipra Lab is registered with the US Food & Drug Administration (USFDA) and approved by Department of Scientiﬁc and industrial Research (DSIR), and provides contract research to various scientiﬁc organizations across the world. Apart from engaging in providing drug development support to the Pharma 32

industry, Sipra labs also provides end to end testing solutions in the food & beverages. The Center has a team of 250 scientist working on different innovative research projects for global regulatory submissions. It has earned recognition as a research organization form its clients across the globe. “our center is having the highest National and International accreditation for quality research. We continuously invest to up-grade our facilities and equipments to comply with the most advanced research requirements. We have one of the worlds most advanced technology and latest and top branding testing tools that are leaders in their particular area of specialization. We comply with all the International standards and are recognized for our quality across the globe.” Says, Dr. V. Satyanarayana, Managing Director, Sipra Labs.

A few specialized services offered by Sipra Labs include crystallography studies, genotoxicty, detecting impurity proﬁle, conducting metabolic studies, novel drug delivery system, method validation, performing stability studies and cytotoxicity. Several national and multinational companies such as Amide inc (USA), Eurodrugs (Holland) Pliva DD (Croatia), Dr Reddy’s Laboratories, Sun Pharma, Aurobindo Pharma, Torrent Pharmaceuticals Ltd, Hetero Drugs Pvt Ltd, Orchid Chemicals & Pharmaceuticals Ltd, etc. Recently the company has also started conducting phase III clinical trials and pre - clinical toxicity studies. “Our aim is to provide end-to-end solutions for Pharma and Healthcare Industry. We undertake all kinds of research, right from Analytical, Clinical and Preclinical Toxicology, Formulation, Micro biological and Food and

Dr. V. Satyanarayana, Managing Director, Sipra Labs December-2010

Beverages. we have our clientele spread across the world. We take orders from them and do customized research and testing according to their needs and requirements . We also take up National research projects and deliver them accordingly.” says Mr. Satyanarayana. The secret behind Sipra Lab’s success is its strong and young talented human resources. With just a 6 member team in its initial days, today the company has grown to a head count of 250 members. There is a continuous recruitment process that is going on and is expected to grow further. The present building is a world class center and could easily accommodate 550 employees. Sipra labs is also collaborating with leading National institutions in the country. Prominent among them are National Scientiﬁc Research Center, NIN (National Institute of Nutrition), Department of Science, MOFPI (Ministry of Food Processing Industry) and APEDA (Agricul-

December-2010

ture product export Development Agency). In house training is also given to police department and employs of government owned food processing departments to upgrade their knowledge periodically. The company also carries out awareness campaigns for the industry and delegations from different countries and delegations from different countries. Working in tandem with the government, Sipra Labs has been conducting awareness programmes for entrepreneurs in India and delegations from South Africa for various quality norms, testing and validation.

Financials With an investment of just 25 lakhs in 1994, Sipra Labs has gradually grown to become a Rs 100 Crore worth company with all its assets today. “During the past one year (2009-10), the company has made a turnover of Rs.22 Crores which is 50 percent growth as against the previ-

ous year. By the end of the year 2012, we are expecting to cross a revenue turnover of more than Rs. 35 Crores.” said, Dr Satyanarayana.

Challenges: The most important challenge in the Pharmaceutical sector is Quality management. For which, a well experienced team of experts is needed. Today, the industry is facing dearth of well qualiﬁed quality manpower. Training fresh candidates is becoming a burden and retaining them to serve for longer is a big challenge. Adapting to newer research methods is a costly affair. There is an ever evolving and changing research procedures based on various factors. For which, new tools and technology is to be upgraded continuously. “Procuring and installing new and advanced equipment is getting over burdened because by the time we recover the cost, the equipment is becoming obsolete.” Said, Dr Satyanarayana.

Gladcare

Formulating health care WITH ITS NEW IDENTITY AS GLADCARE FORMULATIONS FROM GLAXCARE FORMULATIONS, THE COMPANY IS TREADING A JOURNEY OF GROWTH IN THE FORMULATION SEGMENT AND ALONG WITH MANUFACTURING OF MONOPOLY PRODUCTS.

STARTED IN 2005, THE

COMPANY IS AN EXAMPLE OF CONSISTENT PERFORMANCE AND STRONG IDEALS.

onsiderable sales increasing and strong road map of growth is what Gladcare is eyeing in the coming few years. The category of formulations also increased, now the company is eager on prospective markets like South Africa. Gladcare’s products range from antibiotics, anti-ulcerants, multivitamins, and haematinics & calcium preparations to anti-allergic, diabetic range along with neurological and cardiac, digestive and proteolytic enzymes, anti-fungal and anti-spasmodic formulations. The company estimated 50 per cent cumulative annual growth rate. “We are now entering the export market and the plant will support domestic and export markets in the coming years,” said Srinivas Mukka, Managing Director, Gladcare. The company has been actively identifying potential markets for exclusive and regular medicines, and aiming to cover new states of the nation in addition to the South and East Indian states.

Srinivas Mukka, Managing Director, Gladcare Formulations

for specialty products, and entering in the export market and the plant will support domestic and export markets in the coming years. Gladcare’s products range from antibiotics, antiulcerants, multivita-

mins, and haematinics & calcium preparations to antiallergic products, digestive and proteolytic enzymes, anti-fungal and antispasmodic,diabetic and cardiac formulations.

Commenting on the growth of the company, Mr. Srinivas further adds, “we have also entered in to new specialty productions with a paediatric range. This coming year, we plan to start marketing division 34

December-2010

Midas

Started Small to grow Big ENSURING A MIDAS TOUCH, MIDAS BIOTEK PVT LTD, IS GRADUALLY CLIMBING UP THE LADDER IN THE PHARMACEUTICAL ARENA. IN A SPAN OF JUST LESS A DECADE, THE COMPANY HAS ACHIEVED REMARKABLE SUCCESS WITH A RANGE OF MEDICINAL PRODUCTS WHICH ARE ACCEPTABLE AMONG THE PROFESSIONALS IN THE COUNTRY AND ACROSS THE WORLD MARKETS.

idas Biotek which was initially born out of a Thought among three enthusiastic entrepreneurs in the year 2001, in a span of less than a decades time, the company has spread its wings not only across the country but has earned a comfortable global recognition for its products in the overseas market. Today it has climbed the ladder of success at every stage and in every step. Indeed, Midas success is an apt example of courage and innovative ideas which have been implemented in the right direction at the right point of time at the right place.

a great ambition, today the company is conﬁdently manufacturing and exporting pharmaceutical formulations. It has become one of the fast growing pharmaceutical formulation company and is continuously been marching ahead garnering all the success on its way, while also toiling hard to gain new knowledge and ideas. “We are very much exited and encouraged with our results over the years and planning to move further up the ladder of success. The secret of our success is the net result of acceptance of our product range by the medical fraternity globally coupled with the co-ordination among Quality assurance, production, planning, materials, ﬁnance and distribution departments of the company,” said P Krishna, Director, Midas Biotek Pvt Ltd. As a part of Midas expansion, an areas of 12000 square feet of plant is already in construction. The completed building is awaited to be operational in January 2011. The new

construction area consists of exclusive manufacturing facilities for Betalactam. The upcoming facilities are well in concatenation to the GMP standards. The company has already build up a plant complying with WHO GMP standard with a state-of-theart facility. The ﬁrm is ISO: 90012000 certiﬁed and is located in a pollution free area in the outskirts of Hyderabad. Commenting on the new unit, Mr. Krishna says, “In this unit we wish to have independent ultra modern automatic manufacturing facilities to manufacture tablets, capsules, injectables and ointments to cater the needs of the needy.” “our expansion plans are purely based on our successes, which have encouraged us and prompted us to expand our product range and marketing activity in various segments,” said Krishna. At present the company covers psychiatry, neuro, cardiovascular, Gastrointestinal (Gi) tract, skin, and respiratory segments.

Having understood the basic needs of the common man, Midas has been striving hard to produce cost effective quality medicines, at affordable prices. Not only this, Midas is also trying to match itself to the needs of different faculties of the medicine market under stringent quality control, that are well accepted by the medical profession in Indian and across the global markets as well. As its name reﬂects, Midas Biotek , is surely giving a careful and caring touch to its future endeavor. It has the potential to turn simple ideas into golden business models and even securing lives. That’s the Midas touch that the company holds. Began with 36

Midas Biotech manufacturing facility December-2010

Andhra Pradesh

The Potential Pharma hub Interview excerpts of Dr. P.V.APPAJI (Pharmexcil) DR. P.V. APPAJI, EXECUTIVE DIRECTOR OF PHARMEXCIL, HAD EARLIER WORKED IN THE MINISTRY OF COMMERCE AND INDUSTRIES GOVERNMENT OF INDIA AND PRIOR TO THIS HE WAS PART OF DRUG CONTROL BOARD, GOVERNMENT OF ANDHRA PRADESH. AIRING HIS VIEW TO AMGUTH R AJU, HE SAYS, “ANDHRA PRADESH HAS TREMENDOUS POTENTIAL TO BECOME THE PHARMA HUB IF THE OPPORTUNITIES ARE TAPPED WELL IN TIME.”

How do you view the evolution of Pharma sector in Andhra Pradesh and where do you place the state in terms of production of bulk drugs, generics and formulations in the country? Andhra Pradesh is recognized as a Pharma hub for manufacturing Bulk drugs in the country. In terms of formulations Andhra Pradesh is second leading exporter only after Maharashtra in the country. Day by day the volume of Bulk drugs and Generics is increasing. Due to low cost of generic medicines the demand for generic medicines is very high. Today, if the international market for bulk drugs is approximately 20 percent, the rest 80 percent is for Generic medicines. Right from the beginning Andhra Pradesh is concentrating more in the Bulk drug sector and over the years the state had attained a great reputation in the world as a producer of quality bulk drugs in India. Though Andhra Pradesh is second largest exporter of formulations but that also comes from only a few handful Pharma companies. Unfortunately, we are not focusing more towards the formulations. There are December-2010

Dr. P.V. Appaji, Excecutive Director, Pharmexcil

very few companies that are involved in formulations. Gujarat is taking a lead in this sector and had stabilized its market strength. They have expanded in the global market. And it is obvious that AP is lagging behind with all the leads going to Gujarat. Andhra Pradesh did good in Bulk drugs because of two important companies like IDPL and SOL. For they have speedup the growth of new and evolving Pharma companies in the state. Other important issue which helped AP in becoming a leader in bulk drugs is because of the Drug Policy of India. AP had manufactured bulk drugs right from basic stage. It did not depend on other markets for help. Its import component in bulk drugs was very little between 1980’s and 1990’s. After liberalization, because of open markets and because of relaxation of restriction on imports, we have been completely depending on the Chinese for the drug intermediaries. China is very strong in exporting drug intermediaries and our over dependence

on them is not a good development for the future Pharma industry of the country. We need to produce our own intermediaries and in-fact we our self should supply it to other countries. How is the State government supporting the Pharma sector and what are the future prospects for the industry to grow in Andhra Pradesh? The Pharma industry in the state feels the state government is unfair in restricting the production without showing viable production and pollution control norms. The industry is forced to bear additional costs because of the strict regulations. Specially the Bulk drug industry is facing lot of threat and chances of shifting their bases to other states like Himachal Pradesh and Jammu and Kashmir is very high as they are providing cent percent duty free production facilities. Moreover the state is known only for bulk drug manufacturing. The formulation industry is very very small. This is a negative sign for future 37

sustainability of the Pharma sector in the state. The good thing about Andhra Pradesh is that, it is known for its quality production. The international drug market identiﬁes Andhra Pradesh as the best quality drug producer in the country. Some of the Bulk drug companies in the State enjoys global monopoly for certain special products like Virco Sulpha Oxazole, Randitine anti ulcer drug, Ibupufrene, Ciproﬂoxine etc. The other negative aspect about Pharma sector in the state is that most of the companies are totally dependent on the China for their raw materials.

incentives for the Pharma sector to catch up the past pace of growth with the It sector. In fact the Pharma sector could take the beneﬁt of IT ﬁrms to manage research data and provide knowledge solutions for the Pharma industry. What exactly would you like the government to do for the future development of Pharma sector in the state? For the Pharma sector to grow and sustain challenges in the next few years to come, the state government should constitute a special Pharma body ( such as Andhra Pradesh Drugs & Pharmaceuticals

Today Pharma Companies are known for their quality product and it can be evident for they have been approved by the USFDA in America and EDQUM in Europe.

Frankly, the state government has to do a lot to usher the Pharma Industry. Pharma sector is being strictly regulated, it is not much pampered as that of the IT sector in the state. The state government should give special 38

As of now only very few companies like Dr. Reddy’s, Aurobindo and Natco are involved in manufacturing formulations in the state. Most of the Pharma companies are focusing only in bulk drug production. More so they import almost 90 per cent APIs from China. Long time dependence of imports from China may impair future growth in the bulk drug production. It is high time that the government understand these limitations and take adequate steps to make the Pharma Sector in the state self sufﬁcient even in the APIs and Generic. For the Pharma sector to ﬂourish further, Government should accelerate the provision of basic infrastructure such as land,

A large number of Companies in Andhra Pradesh are producing antiHIV drugs and exporting them to the western world. Aurobindo and Heterio are some of the top world renowned Pharma Companies from

the State. Dr. Reddy’s Labs is not less than any MNCs like Fizer or GSK in the world.

then concentrating only on bulk drug production.

Body) headed by the Chief Minister to look in to the policy matters and evolve new time bound strategies and attract more investors in the formulation and generic sectors rather

water, efﬂuent treatment plants, and power at reasonable price. The drug control regulation body and the pollution control body should relax some of the stringent rules and regulations that are resisting new investors to come to the state. What according to you are the main strengths of Andhra Pradesh? Andhra Pradesh has a very good December-2010

talent pool and it is the knowledge hub of the country. Apart from from two most reputed institutions like the National Institute of Life sciences and NIPER, there are a large number of Pharma colleges and research institutions that are working towards the advanced research in the Pharma sector in the state. National Institute of Pharmaceutical Education and Research (NIPER) is a National level institute in Pharmaceutical Sciences with proclaimed objectives of becoming center of excellence for advance science and research in pharmaceutical sciences. Previously, there was only one NIPER at Mohali. Later, the Govt. of India (Ministry of Chemicals & Fertilizers) has started 6 such institutes under the aegis of this Ministry. NIPERHyderabad is one among them. The Institute of Life Sciences (ILS), an associate of University of Hyderabad another signiﬁcant institution which is involved in conducting innovative research in unifying areas of chemistry, biology and chemical biology. These knowledge institutions are striving hard to create and foster a research culture where chemists and biologists work together to generate original ideas, and generate experimental data which can lead to novel therapies for human disease and an improvement in quality of life. Which are the best Pharma Companies in Andhra Pradesh that are listed among the top 20 companies in India? There are about 400 registered Pharma companies in Andhra Pradesh. Among these 217 companies are exporting different pharmaceutical products to various countries in the world. There more than 20 companies in the state whose export turnover had crossed more than Rs 45 Crores during the year 2008-09. Dr. Reddy’s Laboratories Ltd is among the leading Pharma Companies with export turn over crossDecember-2010

ing more than Rs 2000 Crores in the State. In the year 2006-07 Dr. Reddy’s had a record export turnover of Rs. 3,053.63 Crores, while it was decreased to Rs 2,319.40 Crores in 2007-08, it slowly picked up to Rs 2,892.50 Crores in the year 200809. Aurobindo Pharma Limited is racing next to Dr. Reddy’s Labs in the state. During the year 2008-09 the company had shown a record export turnover of Rs. 1,746.65 Crores. A part from these two major Pharma giants Matrix Laboratories and Divi’s Laboratories have also crossed their export turnovers more than Rs 1000 Crores during the year 2008-09. Other Pharma majo rs whose contribution towards exports crossed more than Rs 100 Crores in the state include Shanta Biotechnics, Neuland Laboratories, Granules India, Gland Pharma, Virchow laboratories, Suven Life Sciences and Natco Pharma. What is the role of Pharmexcil and how do you view the performance of the Council during the past one year? Keeping in view the dynamic growth of Indian Pharma Industry and the recommendations of four major Pharma associations made the

Ministry of Commerce & Industry to realize the need for separate export promotion council. Accordingly, Pharmaceuticals Export Promotion Council (PHARMEXCIL) had been set up in the year 2004. Pharmexcil is the sole agency to issue RCMCs to all Pharma exporters in the country. The activities of the Council are administered by Committee of Administration consisting of representatives from major Pharma industries in India. The role of the council is to issue RCMC, Organizing Trade delegations/ Buyer-Seller Meetings abroad, organizing Reverse Buyer-Seller Meetings in India, assisting members to get their MDA/MAI claims refunded from Government of India, issue of Certiﬁcate of Origin, organizing periodical Seminars/Interactive meetings on exports related issues and make suggestions to Government of India on policy issues relating to Pharma exports. The council also plays a vital role in making representations to Government of India and other agencies in India and abroad to get amicable solutions for the common problems of the industry. During the year 2008-09, Pharmexcil had organized many national and international events. Some of the important events include Meeting on REACH program which was organized to bring awareness about the necessity of registration for the exporters of APIs and Intermediates to EU countries. Grievances Committee Meeting of Jt. DGFT, interactive meeting with DCGI, DST, DGFT and AYUSH. Other signiﬁcant event organized by Pharmexcil is the Brain Storming session on review of prices and availability of imported APIs arranged by BDMA. Apart from these events the Council had also organized many Seminars on Institution initiatives for SME exporters. 39

Future Lies Behind the Hurdles Interview excerpts of ORS Rao, Director, Cygnus Business Consulting & Research Pvt. Ltd How do you view the growth of Pharma Sector in Andhra Pradesh? Andhra Pradesh has grown in to a Pharma hub for Bulk drugs basically for two reasons. Historically it is because of IDPL and secondly because of entrepreneurship and availability of adequate talent pool in the state. IDPL (Indian Drugs & Pharmaceuticals Limited) which was set up at the behest of India’s first Prime Minister Pandit Jawahar Lal Nehru in the year 1961 was India’s largest public sector drug maker in the early days. The company was set up to enable the country attain self-sufficiency in life-saving drugs. Unfortunately IDPL is saddled with accumulated losses of Rs 5,000 crore and has a negative net worth of Rs 4,816 crore. Had there not been IDPL, the Bulk drug industry in Andhra Pradesh wouldn’t have seen the present day. Though the Company was a flagship and front runner in the early days, the paradox today is many private sector drug manufacturing companies have overtaken it and are performing on par with the international standards giving stringent competition to the global drug markers. Today, Andhra Pradesh has become the preferred destination for investments in pharmaceuticals for Indian as well as foreign multinational companies. It will also be a center for pharmaceutical healthcare education and research and will be known for innovation in these areas. The State already has a dominant position in the pharmaceutical industry with 33 per cent share of bulk drugs produced in the country. In value terms, the industry is worth US$ 1.6 billion and the State will leverage 40

Dr. ORS Rao, Director, Cygnus

its strong position to emerge as the next global hub of pharmaceuticals with a share of around US$ 8-10 billion by 2010 and US$ 15-20 billion by 2020. The State exports over US$ 500 million of pharma products. It has over 2,500 pharma companies and is home to two of the top ﬁve Indian pharma companies, viz., Dr Reddy’s Laboratories and Aurobindo Pharmaceuticals Ltd. What are the major strengths of Andhra Pradesh? As said earlier, Andhra Pradesh has an established pharmaceutical base starting with IDPL and a strong R&D base with reputed institutions like Indian Institute of Chemical Technology (IICT), The Centre for Cellular and Molecular Biology (CCMB), Centre for DNA Fingerprinting & Diagnostics (CDFD) and National Institute of Nutrition (NIN). After setting up the Biotech Park and the ICICI Knowledge Park near Hyderabad, the government is in the process of creating a Pharma City at Parwada near Visakhapatnam under public/private partnership. The Pharma City will have world-class infrastructure on an area covering 2,200 acres, with state-of-the-art

environmental protection measures. This will facilitate the local industry to expand its manufacturing facilities. What are the challenges faced by Pharma sector in the state and what according to you are the possible solutions for the same? In the event of private sector taking over the public sector giant, now the challenge for the Pharma industry is to sustain its base as a bulk drug maker and move up the value chain. Though the situation seems to look stable but due to delayed government processes and lackadaisical attitude of ofﬁcials in the government there is a possibility that Pharma sector may slowly drifting its base to other states like Gujarat, Maharashtra, Himachal Pradesh and Jammu & Kashmir which are offering better incentives. Moreover merely focusing only on bulk drugs will not serve the future sustainability of the sector in the state. The industry has to move up the value chain should focus more on formulations and generics which are in great demand. December-2010

Though firms in the state are self sufficient in bulk drugs but their over dependence on imports of APIs from other countries like China, Switzerland and Australia is of serious concern as it may impair the future growth of the industry. There is a serious need for the government to look towards this front and gradually reduce over dependence on imports of APIs and provide adequate infrastructure facilities and financial assistance to newer firms and encourage them to develop APIs in the state. The Pharma industry should also focus more to capture the retail markets where the profit margin is more rather than serving the wholesale market with low profits. There are approximately 600 to 650 notified small and big Pharma companies in the state. Among these, only 30 to 40 of them are CGM certified and concentrating in to formulations. The remaining lot is involved in Bulk drug production. Most of them are exporting the bulk drug products to other countries. Basic problems faced by all the Pharma companies in the state are related to Infrastructure. Foremost among these is availability of reliable uninterrupted power. As most of the Pharma firms are power intensive, they are incurring huge costs to install power back up facilities. The government should look in to this matter seriously and provide round the clock power facility to the Pharma industry which is very crucial especially for the formulation industry. Apart from reliable power, non availability of sufficient water and effluent treatment plants are among other concerns. The state government should come forward to construct a common effluent treatment plants and also encourage more investors by way of announcing more liberal incentives. Secondly, the logistics in the state are not well developed. Despite having an International airport in the state, there is no container cargo facility at Shamshabad airport to export Pharma products directly to interDecember-2010

national markets. There are very few direct international flights from the state. The frequency of freight trains to destinations like Mumbai, Chennai, Bangalore from Hyderabad are very few. The internal roads and rails ways are not well equipped to transport costly drugs and chemicals faster and safer to the intended destinations. The Pharma industry is incurring huge cost towards transportation as it is forced to go to Chennai or Mumbai where our consignments are given second or third priority because of which the industry is incurring losses in revenue due to unavailability of transport logistics. Thirdly, the Pharma industry is lagging behind in the quality awareness. The firms in Ahmadabad are far much better than Hyderabad in terms of quality awareness and many have attained GMP certification. GMP refers to the Good Manufacturing Practice Regulations. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time. Fourthly, though Hyderabad is having qualified professionals, most of them are attracted towards white collar jobs in IT industry, because of this the Pharma industry is facing problems of non availability of skilled and semiskilled labours. The Industrial Training Institutes which are know for creating semiskilled labour are not adequately equipped to produce required work force in Pharma industry. It is high time that the government should introduce Pharmacy courses in the ITI colleges in order to meet future labour force in Pharma sector in the state. Finally, 80 to 90 per cent of Pharma industry in Andhra Pradesh is concentrating only in the 4 districts of Rangareddy, Medak, Nalgonda and Hyderabad. Lot of chemical effluents

from the different factories are polluting land, water and air in the state. The state government should construct a common efﬂuent treatment plant and shift the Pharma companies to other districts where it will not only reduce pollution but also increase local employment and reduce stress on urban areas. How do you view the growth of SEZs in the state? Are they becoming operational? Government of Andhra Pradesh, with the Central assistance had supported Pharma industry by grounding two Pharma SEZs one at Jadcherla in Mahabubnagar district and the other in Visakhapatnam district. The Pharma SEZ in Jadcherla had already started its operations since 2009. City-based Aurobindo Pharma, which was allotted 75 acre had already commenced its operations. Nine other formulation companies are setting up their units in the SEZ, which is coming up on 250 acre on the Hyderabad-Bangalore highway at Polepally. On the whole, the SEZ is expected to attract investments to the tune of Rs 500 crore, the largest in the backward Mahabubnagar district in the Telangana region. Aurobindo has invested Rs 157.63 crore in the unit that would generate direct employment for about 1,500 people and indirect for 3,000. The company has a capacity to make 700 million tablets and 16 million capsules per month. Recently the state government had also allocated an area of 800 acres land to build a Pharma City with an estimated cost of Rs. 350 Crores at Parawada in Visakhapatnam district. The pace at which these SEZs are operationalized is very slow. The state government should accelerate the land acquisition process and develop the basic infrastructure facilities to enable the pharma companies to establish their bases and start their operations at the earliest.