Pride of Pharma by Nadimidoddi Prasad

Pride of Tamil Nadu 2008

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Pride of Pharma- 2008

INDUSTRY OVERVIEW

Andhra Pradesh and India are fast racing to meet the topend players in the global pharma terrain and it seems to have everything going its way. The state and the country, along with few other players (States) have shown the world what intellect, investment friendly policies, changing lifestyles, growing awareness and a rare spirit to reign supreme can do to achieve phenomenal success.

Reigning Supreme in the Pharma Terrain The state of Andhra Pradesh invariably represents an important centre of activity for the Indian pharmaceutical industry. Andhra Pradesh accounts for more than one-third of India’s

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total bulk drug production. A major share of the bulk drugs produced by AP-based

THE ANDHRA PRADESH STATE BUDGET PROJECTED AN INVESTMENT OF RS.38,671 CRORE IN THE NEXT TWO –THREE YEARS AND CREATION OF 1,30,458 JOBS. THE SECTORS OF CEMENT, STEEL, PAPER, BULK DRUGS AND PHARMACEUTICALS, TEXTILES ARE EXPECTED TO DOUBLE THEIR CAPACITIES BY 2010.

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companies finds its way to foreign markets. The state budget projected an investment of Rs.38,671 crore in the next two –three years and creation of 1,30,458 jobs. The sectors of cement, steel, paper, bulk drugs and pharmaceuticals, textiles are expected to double their capacities by 2010 and lot many MNCs (multinationals) are showing interest in setting up their units in the state. The turnover in the pharma sector will also increase to Rs.20,000 crore from the present Rs.12,000 crore in the next three years triggering pharma exports to Rs.11,000 crore from the present Rs.7000 crore. According to CII, The pharmaceutical industry in Andhra Pradesh was set to register a buoyant growth during October 2007-March 2008, with the demand expected to go up to 12.5-17.5 per cent. This would raise the production levels by 25-30 per cent. The sales turnover is likely to increase by 20-25 per cent and exports by 30 per cent, while value of

Pride of Pharma- 2008

production is expected to go up to 20 per cent during the same period. According to a biannual industry monitor survey conducted by the Confederation of Indian Industry (CII)-southern region, the industry registered an impressive performance during April-September 2007. Its production level and the production value increased by 20-25 per cent and 15 per cent respectively, while sales and exports went up by 15-20 per cent.

The Indian Scenario The pharmaceutical industry in India is large, and rapidly growing. It is expected to grow from $ 5.5 billion to $ 25 billion by 2010 and $ 75 billion by 2020 and create 1.8 million additional employment, US$ 12-13 billion exports and US $ 4-6 billion investment for the country. According to CII, Export of pharmaceuticals from the country increased 16 per cent in 2007-08 compared with

“The industry, however, is concerned about the

the previous financial year. According to provional figures

unavailability of raw materials for oncology and neurology

available with Pharmaceutical Export Promotion Council

drugs that are currently being sourced from China. It also

(Pharmexcil), the pharmaceutical exports in 2007-08

seeks automatic renewal of manufacturing licence and

stood at Rs 28,703 crore against Rs 24,600 crore in 2006-

simplification of export procedure for neutraceuticals,” it

07.

stated. The agro industry too registered an increase in production and sales by 20-25 per cent and 20-22 per cent respectively during April-September 2007. Its exports and profit margin, however, plummeted 25 per cent and 5 per cent respectively. During October 2007-March 2008, agro industry in the state expected a 10-15 per cent growth in demand and 15 per cent growth in production and sales. “Availability of skilled manpower and high capital investment requirement are some of the concerns impacting the performance of the industry,” the report said.

Though the growth rate had come down by two percentage points in comparison with 2006-07, which registered about 18 per cent growth over the earlier year, the overall growth is satisfying at a time when the rupee’s appreciation against the dollar was a major concern. The increased competition from China in global markets and the appreciation of the rupee against the dollar were behind the dip in the growth rate compared with that of 2006-07. The growth in exports was mainly driven by India’s increased share in global new formulations business. The Domestic pharmaceutical market is going

However, performance of the IT industry in the state took

through a transformation, led by strong underlying growth

a backseat during April-September 2007, registering a

drive.

moderate growth. The industry’s revenue went up by a meagre 5-10 per cent and the level of employment increased 10-15 per cent. “The industry expects 10-15 per cent growth in revenues and an increase of 25-30 per cent in employment during October 2007-March 2008,” it said. The survey was carried out to analyse the performance of top five sectors - pharmaceuticals, agro, manufacturing, IT and textiles – which were identified on the basis of their contribution to the state gross domestic product (SGDP). It was carried out in five states – Andhra Pradesh, Karnataka, Kerala, Puducherry and Tamil Nadu.

The prospects of the Healthcare and Pharmaceuticals industry are strongly linked to economic growth. Over the last couple of years, the pharmaceuticals industry has grown at approximately 1.5-1.6 times the growth of economy. The rise in disposable income has a positive impact on healthcare spend. Both healthcare delivery and infrastructure segments are going through a structural change with the entry of corporates. Significant investments have been lined up in the domains of organized pharmacy chains and private hospitals. In

Pride of Pharma- 2008

INDUSTRY OVERVIEW

expected to further drive the growth of the domestic pharma market. Initiatives The Government has introduced several development programmes to improve the access to and quality of the healthcare services in the country. The National Rural Health Mission (NRHM), introduced by the government to provide basic healthcare amenities in the rural areas, is expected to increase the access to drugs in the rural areas. In Budget 2007-08, the budgetary allocation to health was increased by 22 percent to INR 1,52,910 million. India’s pharmaceutical sector is currently undergoing unprecedented change. Much of this is due to the country’s introduction, on 1st January, 2005, of a system of product patents. Both multinational companies and addition to Metros even B and C category towns are

domestic players are examining the prospects offered by

witnessing sizeable investments. Many pharma companies

the local market as the government moves forward with

have expanded their sales force in order to cater to these

initiatives aimed at providing India’s more than one

untapped markets.

billion inhabitants, for the first time, with access to the

Factors Driving the segment

life-saving drugs they need. A further huge boost to the local market is emerging from the rise of India’s new

Following factors will drive the growth of the domestic

affluent consumers, who lead more Western-style lives

market: Increase in disposable income, newer therapeutic

and are demanding innovative drugs to treat the chronic

segments, newer markets, and semi-urban and rural

illnesses that these changing lifestyles may produce.

areas. Last but not the least is health insurance. Also, the

India’s leading drug manufacturers are becoming global

growth in the domestic market would be based on

players, utilising both organic growth, through the

volumes rather than price. At present, organized players

gradual development of their business, and mergers and

account for a meager 2 percent share of the pharma

acquisitions as they seek to boost their presence in

retail market. It is expected that with the advent of

existing markets and open up new ones. With these

modern retailing in India, increasing investments in this

opportunities, however, there are huge challenges that

space will multiply the availability and accessibility of

require commitment by both industry and government,

pharma products.

and unprecedented levels of partnership between them. The Patent Act of 1970s was primarily introduced to

The organized pharmacy chains will not only capture an

develop Indian pharmaceutical industry and to make low

increasing percentage of the total market but will also

cost drugs accessible to Indian consumers. Here, the

expand the market with value added services and

manufacturing ‘process’ patents were given preference

enhanced offerings. The culmination of all these factors is

to product-specific patents, which allowed Indian

Pride of Pharma- 2008

companies’ to reverse engineer or copy foreign patented

manufacturing base will stand some global companies in

drugs without paying a licensing fee. This allowed the

good stead as well. Easy availability of investment capital

domestic industry to build up considerable competencies,

and increasing R&D capabilities are major factors

and offer a large number of cheaper generic versions

attracting global players for M&As in the Indian pharma

legally in India at a fraction of the cost compared to their

sector. Other factors such as change in lifestyles, a greater

global counterparts. On the other hand, prices were

per capita expenditure on medicines, higher process and

controlled through The Drug Prices Control Order (DPCO),

re-engineering skills, low manufacturing costs and quick

which ensured the affordability aspect. Thus, the need,

adaptation to new technology would also help the country

availability or the desire to commit funds to developing

to position itself as a preferred manufacturing destination.

new chemical entities was low.

The major pharma mergers and acquisitions in 2007 can

However, the industry underwent a major change after

be enlisted as Wockhardt’s acquisition of the French

introduction of Patents (Amendment) Act 2005. To meet

company Negma Laboratories for $265 million and the US-

its TRIPs obligations, India amended its 1970 patent law

based Morton Grove Pharmas for $38 million; Jubilant

in 2005 wherein, in addition to process patents law,

Organosys’ acquisition of Hollister-Stier Laboratories of the

product patents were reintroduced. It also made reverse

US for $122.5 million; Alembic’s buyout of the entire

engineering or copying of patented drugs illegal after

domestic non-oncology formulation business of Dabur

January 1, 1995. Thus, this Act effectively ended the

Pharma for Rs 159 crore. Thus, Indian pharmaceutical

protection regime, resulting in many foreign players

industry came a long way over the years and as is evident

entering the industry. Almost 35 years of protected regime

from the paragraphs mentioned earlier regulations/policies

helped Indian pharmaceutical companies to strengthen

played a crucial role in shaping the Indian pharmaceutical

their scientific and manufacturing capabilities. Today, India

industry.

is one of the fastest growing economies in the world with Indian pharmaceutical industry complementing the pace. Indian pharma companies now need to invest much more in R&D to develop proprietary products in the dawn of the product patent regime and set up world class infrastructure to capture the new opportunities internationally. Another development observed in Indian pharmaceutical industry is mergers and acquisitions. Most of these activities were undertaken by Indian pharmaceutical companies to penetrate overseas markets and widen their global footprint, diversify and enhance their product portfolios, offer their customers an offshore option, improve their R&D capabilities, acquire existing brands, and gain access to the highly regulated markets. With the easy availability of capital, increased global interest in India’s research and development capability,

EASY AVAILABILITY OF INVESTMENT CAPITAL AND INCREASING R&D CAPABILITIES ARE MAJOR FACTORS ATTRACTING GLOBAL PLAYERS FOR M&AS IN THE INDIAN PHARMA SECTOR. OTHER FACTORS INCLUDE CHANGE IN LIFESTYLES, GREATER PER CAPITA EXPENDITURE ON MEDICINES, HIGHER PROCESS AND REENGINEERING SKILLS ETC.

the country’s pharmaceutical industry offers a good climate for mergers and acquisitions. India’s strong

Pride of Pharma- 2008

INDUSTRY OVERVIEW

Imperatives for the Indian pharmaceutical industry The Indian pharmaceutical industry can look forward to years to come, with great expectations. There are opportunities galore—in enlarging the reach of competitive generics as more people enjoy economic prosperity around the world; in expanding the range of

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generic products as more molecules come off patent; and, above all, in enhancing the value footprint into discovery as more profits come from traditional plays, says K V Subramaniam,

LOOKING AHEAD, THE WORLDWIDE PHARMA MARKET IS ESTIMATED TO MORE THAN DOUBLE TO $ 1.3 TRILLION BY THE YEAR 2020. HOWEVER, THE MARKET COMPOSITION AND DEMAND WOULD BE DIFFERENT FROM WHAT WE HAVE SEEN HISTORICALLY.

President and CEO, Reliance Life Sciences At the same time, the Indian pharma industry would have to contend with several challenges—in making generics more affordable so as to address the bottom of the affordability pyramid in a context of rising prices; in maneuvering increasingly protective innovator companies coming to terms with low research productivity and demanding capital markets; and in managing discovery research in a context of talent shortage. We are living in a skewed world, with about 85 percent of the global population having to do with just 15 percent of the economic output. But this is changing, with China and India,

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representing a quarter of global population, seeing rising incomes. They are being joined by Brazil, Russia, Indonesia and some African countries.

Pride of Pharma- 2008

Demand for medicines that treat diseases formerly

industry would see revenue growth of only five percent to

associated with the developed world would be expanding

reach $ 735 billion in the year 2008. Besides having to

to emerging economy countries.

cope with slower revenue growth, pharma companies are

The real GDP of E7 countries—Brazil, China, India, Mexico,

facing host of internal and external challenges.

Russia, Indonesia, and Turkey—is estimated to increase

The core issue for most of the top drug companies is

multi-fold increase to $15.7 trillion by the year 2020.

declining productivity of in-house R&D.

In contrast, G7 countries will grow by just 40 percent, to

In the last ten odd years, despite spending more than

$36.1 trillion. The richer the E7 countries become, the

twice on R&D, there have been 50 percent fewer new

more they would be expected to spend on healthcare.

compounds. Patent expirations of a number of blockbuster

A shift towards a more equitable world opens a whole new world of markets for Indian pharma companies, who were hitherto serving the needs of developed world

drugs, increasing legal and regulatory constraints, more exacting clinical trial requirements and product safety issues are adding to woes.

citizens. This expanding opportunity sphere comes with a

As a result, one can see larger pharma companies shifting

caveat of having to be far more competitive than before,

to new business models around the consumer end of the

given affordability considerations.

value chain, with greater outsourcing of discovery

This calls for innovation for more value to the user,

services, clinical research and manufacturing.

through efficiencies in distribution, logistics and product

Such a shift in the business model and organisation of the

promotion. Indian pharma companies would have to seek

larger pharma industry does spell more opportunities for

new business models around virtual delivery models in

Indian pharma companies. At the same time, they

order to create greater value.

demand greater attention to quality management and

Over the next four years, drugs worth $ 190 billion in

conformance to global GXP standards.

annual revenues would be vulnerable to generics. The global generics market is expected to grow at about 15 percent to reach $ 70 billion in the year 2008. Although every innovator product coming off patent represents an opportunity in its own right, there are finite limits to which a business model characterised by declining prices and greater competition can be sustaining. An accent on run-of-the-mill generics would therefore have to give way to specialty products such as hormones, steroids, peptides and biosimilars. Bringing about better economies of scale and integrated operations in manufacturing would also be necessary.

THE PHARMA MARKET WOULD ALSO SEE CHANGES IN THE WAY DRUGS ARE DEVELOPED, APPROVED AND SOLD— FROM TREATMENT TO PREVENTION, FROM GENERALISED TO PERSONALISED MEDICINE FROM DISTRIBUTION CHAIN TO DIRECT CONSUMER SALES AND FROM MULTILATERAL TO UNILATERAL REGULATORY REGIME.

Above all, a migration in the value chain to branded and own label products would be called for. The global pharma

Pride of Pharma- 2008

I N D U S T R Y A S S O C I AT I O N

As a result of pressures to discover more, global pharma

Global population is projected to grow to 7.6 billion by the

companies are resorting to acquiring innovation, even in

year 2020. At that time, about 719 million people will be

early stage discovery.

65 or more years of age. Most of this growth, as well as

While there are risks inherent in such an approach, nevertheless they spell opportunities for discovery companies and venture capital firms operating in the pharma domain. Unfortunately, Indian pharma companies are not in a position to capitalise on this trend.

the ageing population, would be in emerging markets like India and China. Indian pharma companies would therefore be required to move away from a ‘look west’ policy. For the first time, the seven largest markets will contribute to just 50 percent of growth, while seven emerging markets—Brazil, China, India, Mexico, Russia,

Discovery has been a weak chapter in the Indian pharma

Indonesia, and Turkey—will contribute to nearly 25

story. This is changing though. However, the momentum

percent of growth worldwide.

has to improve.

Scientific developments in the past decde have converted

Traditionally, discovery has emanated either from large

some previously terminal illnesses into chronic conditions.

organisations with surpluses or from research-led

New diseases, including mutated forms of old diseases

academic institutions or from individuals with novel ideas.

are surfacing. These diseases pose new challenges to drug developers.

In the recent past, several large Indian

The pharma market would also see

organisations in non-pharma

changes in the way drugs are

businesses have been seeing surpluses

developed, approved and sold—from

and have an imperative to forge new

treatment to prevention, from

frontiers to create shareholder value.

generalised to personalised medicine from distribution chain to direct

Some of these organisations are turning

consumer sales and from multilateral

their attention to the pharma and health

to unilateral regulatory regime.

care sectors. One could therefore see new sources of competition in the

These scientific, epidemiological and

industry.

social trends impacting the pharma markets would necessitate greater play

Looking ahead, the worldwide pharma

of knowledge, innovation and

market is estimated to more than double

technology in the industry. The

to $ 1.3 trillion by the year 2020.

traditional approach of reverse

However, the market composition and demand would be different from what we have seen historically, influenced by demographic, epidemiological and economic shifts.

engineering and innovation around known discovery targets would simply not be sufficient. As a research-led, biotechnology-driven, nascent organisation, Reliance sees

Pride of Pharma- 2008

Within the small molecule pharma business, Reliance is building an India-based global generics business. While the initial target markets for these products are US, EU and Japan, Reliance would also focus on select rest of the world markets. This position could potentially be leveraged to access the branded generics market in India. Reliance probably represents the most diverse and integrated life sciences plays in the world. The company would also have a very unique, innovation-driven footprint in the medical domain to address global and Indian markets. Opportunities in the global pharma market are undoubtedly promising. At the same time, there are several challenges; key ones being in compe-tency development, scaling up, global operations and enormous opportunities in the global pharma and health

innovation. Reliance Life Sciences is well-placed to

care markets.

address the opportunities and is equally geared to facing

Reliance is building four global verticals—in biopharma,

the challenges.

pharma, clinical research services and biofuels.

(This article was published in Express Pharma: 16-

Concurrently, it is also incubating other global businesses

31 January 2008 issue)

in regenerative medicine, molecular medicine, plant biotechnology, biopolymers and biochemicals. In the medical biotechnology domain, Reliance would have a wide array of products in the plasma proteins, biosimilars, monoclonal antibodies, fusion proteins, siRNA and stem cell therapy categories. In addition, it would have service plays in molecular diagnostics, genetics and clinical research. The recent acquisition of GeneMedix in UK/Ireland places Reliance in a good position to address the emerging opportunities in EU for biosimilars. A strategic alliance with MPM Capital, USA, the largest life sciences venture

FOR THE FIRST TIME, THE SEVEN LARGEST MARKETS WILL CONTRIBUTE TO JUST 50 PERCENT OF GROWTH, WHILE SEVEN EMERGING MARKETS— BRAZIL, CHINA, INDIA, MEXICO, RUSSIA, INDONESIA, AND TURKEY—WILL CONTRIBUTE TO NEARLY 25 PERCENT OF GROWTH WORLDWIDE.

capital firm in the world, enables Reliance to access innovation outside its own corporate boundaries.

Pride of Pharma- 2008

C O M M U N I C AT I O N S

Proactive Communication can be Key

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NOT MANY PEOPLE WOULD BE SURPRISED TO LEARN THAT PHARMACEUTICAL COMPANIES ARE SPONSORING PROJECTS IN DISEASE STATES THEY HAVE AN INTEREST IN. DRUG FIRMS ALSO DEVELOP RELATIONSHIPS WITH NON-PROFITS BECAUSE DOING SO HELPS TO BOLSTER THEIR REPUTATIONS.

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Pharma companies are in a race, bringing exciting new drugs to market and publishing critical milestone data. Many are into clinical research developing strategic partnerships. There are some indications that pharmaceutical companies will develop more cause alliances as they seek to educate the public about illnesses their drugs are designed to treat. However, in recent years, the media and parts of the medical establishment have been increasingly critical of cause alliances. Some view them as examples of “disease mongering,” or shaping the medical environment to increase awareness and sales of expensive medications, says Md. Shah Alam Javid of MakroCare Clinical Research Ltd., Hyderabad. Over the past decade or so, pharmaceutical companies have worked with advocacy organizations and medical societies on a range of projects designed to raise awareness of illness and educate physicians on issues relating to products they manufacture. These “cause alliances” have been win-win relationships for all involved because they provide nonprofit groups with valuable funding for ongoing projects and help to draw medical and public attention to issues drug firms are concerned about.

Pride of Pharma- 2008

Public relation firms serve as liaisons between the drug firms and all the stakeholders. Public relations campaigns have generated strategic media awareness and business impact for biotech and pharmaceutical companies. Just as superior science provides the competitive advantage in life sciences, media relations can be the critical difference between marketing failure and success. The science of media relations and PR campaigns that create product and technology visibility, promote regulatory decisions, drive physician acceptance, raise awareness of public health issues and generate patient enrollment in clinical trials etc, etc., While direct advertising gets the most attention, critics are also looking at how pharmaceutical companies work with public relations firms and non-profit organizations on projects relating to products they manufacture. Not many people would be surprised to learn that pharmaceutical companies are sponsoring projects in disease states they have an interest in. Drug firms also develop relationships with non-profits because doing so helps to bolster their reputations. Most importantly, third party endorsement helps to lend credibility to Big Pharmaâ&#x20AC;&#x2122;s arguments about why its products are needed and useful. However, growing negative scrutiny of these efforts threatens to significantly damage the reputation of nonprofits that are working with pharmaceutical companies. Over time, these organizations may lose credibility with the public and their stakeholders, which will ultimately harm public health. What may help is more transparency from pharmaceutical companies and third party organizations. This will help to defuse criticism and provide evidence that these activities are worthwhile and that non-profits are indeed operating independently. For example, some drug firms are taking steps to ensure that their marketing departments are not involved in

providing unrestricted educational grants to third parties working in areas they have a financial interest in. Certain medical non-profits have developed very elaborate systems to ensure that Pharma-sponsored projects are truly independent. However, the public and media are largely unaware of these efforts. Proactive communication about why cause alliances were developed, who is sponsoring a campaign, the procedures used to make treatment recommendations and other issues may help to assuage doubts about cause alliances. It may also preserve the credibility and reputations of both third party organizations and pharmaceutical companies. While people will still be skeptical of cause alliances, they will have the information they need to judge them on their merits, for which Public Relation plays a vital role to project positively and maintain credibility. (The author, Md. Shah Alam Javid is Communications Manager, MakroCare Clinical Research Ltd., Hyderabad.)

Pride of Pharma- 2008

CRO S

The IT requirement of Clinical Research Organisations differ based on their business activity. Nandini Patwardhan explores the various clinical research automation solutions being implemented by CROs.

CROs on mission IT Given the very information-oriented nature of their business, Clinical Research

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Organisations (CROs) are at the forefront of Information Technology (IT) adoption. This

IN THE EDUCATION SECTOR, THE CHENNAI CORPORATION HAS WON THE ‘WORLD LEADERSHIP AWARD’ FOR PROMOTING LIFE SKILLS AND HIV PREVENTION EDUCATION AMONG ADOLESCENTS IN CORPORATION SCHOOLS. WE HAVE ALSO WON CRISIL AWARD FOR EXCELLENCE IN MUNICIPAL INITIATIVES.

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sector has deployed a variety of IT solutions that enable them to key in, analyse and interpret volumes of data and report as per the standards laid down by the regulatory bodies. The wish-list Normally, the IT requirements of CROs vary depending on the kind of business activity they undertake. "Some CROs do only data management, while others do clinical trial management. Then there are some others, who are into data capturing. So, it depends on the kind of outsourcing jobs that these CROs have, which eventually determines their technology needs," explains Subhomoy Sengupta, Senior Director, Applications Sales at Oracle.

Pride of Pharma- 2008

A CRO needs IT solutions in areas ranging from data

capture the data online from a site, which will reduce the

management, clinical trial management for statistical

time of data management substantially. This will also

analysis, data backup and so on. Further, IT-based

enable the CRO to lock the database within the shortest

solutions are required for maintaining database of

period of time possible and submit the data for analysis.

investigators, trial material inventory management and for enabling collection of data from subjects through

ACT also uses a clinical trial management system, to

various electronic gadgets, such as patient diaries and

reduce the paper flow within the office and also between

programmed electronic devices. "There is no end to

the CRO and the sponsor. This system serves as a single

requirement of IT in a CRO. It takes shape as the

source of information on the status of any project, either

organisation grows. In the CRO industry, compliance to

by the CRO or by the sponsor. These implementations

regulatory requirements such as CFR Part 11 and

have helped them cut down the data closure time for

validation of systems plays a major role," states

sponsors substantially.

Venkatraman Sunder, Vice-President, Operations, Asian Clinical Trials (ACT). "For instance, at ACT we have automated data management, clinical trial management and the document management system," he adds. What is in?

Wellquest, on the other hand, has implemented IT solutions in the analytical aspect of operations. "All my analyticals are covered by IT. As far as clinical side is concerned, we still use manual paper, which is the same case with many CROs, who are in the BA/BE studies," affirms Aravinda Babu P, Vice-President, Head-

Currently, all the data management activity is automated

Operations, Wellquest Clinical Research.

and ACT has a capability of creating an electronic CRF to

Pride of Pharma- 2008

CRO S

"The rationale behind the in-house development is a general observation, that when you take an off-the-shelf solution, you have a little bit of limitation in customising it to fit your process perfectly, and many a times you end up titrating your process to the capabilities of the software," explains Vasudeo Ginde, President and Managing Director, iGATE. However today, the CRO is exploring off-the-shelf solutions to manage and present information to its customers in a universally accepted format. "A lot of the clients have taken a close look at our systems and liked it because of the flexibility, transparency and the work that we do here. But when it comes to data management, it doesn't really matter how good your internal software is. It is their need and then you got to do that," declares Ginde. Popular products "We have software packages like WINonline, SAS, Class VP and STMS called NuGenesis. These are all Windowsbased for better data authentication, data sanctity, data storage, retrieval and production," he adds.

There are many solutions available in the market from well known players like Oracle, SAS, Microsoft, and also from some smaller players. "The packaged solutions essentially fall into two categories; one is data management, which is where SAS is reasonably strong.

Similarly, the Hyderabad-based Vimta Labs too have

The other part is clinical trials management, which is

invested in SAS, WINonline and NuGenesis. "Indian CROs

Oracle's strength area," says Sengupta.

at present are driven by sponsor and regulatory requirements. What is acceptable to regulatory bodies is implemented on top priority basis. For example, we are using software tools acceptable to regulatory bodies such as USFDA and European regulatory agencies," elucidates Dr I S Gandhi, Medical Director, Vimta Labs. Self reliance While most CROs implement off-the-shelf solutions, there are some like the Mumbai-based iGATE, which rely on inhouse solutions. iGATE has developed and implemented Electron, which is validated and is 21 CFR Part 11

SAS's PheedIt is a Web-based solution built on the SAS platform. According to George Varghese, Director, Pharma, ITeS and Mid-markets, the software centres on the four pillars of SAS technology areâ&#x20AC;&#x201D;usability, manageability, scalability and interoperability. "Frankly, most CROs operate on the Windows platform and I have rarely seen any working on a UNIX. But in case they need to do that in the future, for any other kind of application, SAS supports that. We are oblivious to the kind of hardware or operating systems that they use. It's a truly open system," explains Varghese.

compliant. It is capable of both paper, as well as

"As far as Oracle Clinical is concerned, it is a proven

Electronic Data Calculation (EDC).

solution, which has been tested and has been working in

Pride of Pharma- 2008

this environment which is highly regulated. Most of the jobs that CROs get are from global pharma players, where clinical is also a part of the job. Thus, there is a big push from the pharma companies for CROs to remain on Oracle Clinical," states Sengupta.

CRO PRSENCE IN AP MAKROCARE MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology,

In addition to giving a fillip to the overall quality of data

and medical device industries. It offers major services such as - site selection, patient recruitment, project management, clinical data management, biometrics, statistics and more

generated, IT also helps in cutting down the costs and

SRISTEK

Benefits galore

time involved for conducting various processes. "Additionally, it also reduces paper load required for regulatory submission, allows sharing of data with sponsor on real time basis and reduces site visits for data monitoring," explains Gandhi. "IT implementation increases the validity of the data

As a CRO, the services provided by the Company to the field of Life Sciences have a pleasant blend of research and technology. The services can be broadly categorised into the fields of Clinical Research Services & Operations; Clinical Data Management; Biostatistics; and also Staffing Solutions.

generated as it cannot be manipulated. Also, the back-up

capture any changes along with reason for the same,

functions ensure that the necessary data is still available

which needs to be recorded. So even two to three years

even in case of adverse situations like a fire. Audit trials

down the line, a person can see from the server level and

Pride of Pharma- 2008

CRO S

not only from the computer level," explains Babu. IT also

Varghese has a different perspective on this. He opines

enables the removal of 'individual' from the whole

that customers will not be interested in understanding a

equation, by making the process individual-independent.

product's performance levels in case of established brand

Look before you leap

names. What they will look at is the kind of support provided in terms of training, implementation and 24x7

However, it may not be a very wise decision to implement

technical helpline. Giving an example of Toyota Corolla, he

IT solutions just because it is the current trend. IT is a

asks, "When Toyota Corolla was launched in India few

double-edged sword. While it can help CROs streamline

years back, did people have a problem buying that?

their processes, there also have been situations, where

However, people will definitely be interested to find out

CROs have implemented solutions that have made

whether you have a service centre, can I get my spares,

processes more tedious. Also, the investment made by

as and when I want it. So those are the things that people

CROs can range from Rs 50 lakh for basic systems to a

will look at." Both Oracle and SAS offer implementation

few crore. Hence, any kind of IT implementation needs to

guidance and training to the customers' executives once

be backed by sound thinking and a compelling reason.

the implementation is done. The crux of any IT implementation is not just installing the necessary

"The first step is to evaluate the strategic information

software on a machine.

management needs of the sponsor, regulatory agency and the investigator team, which are essential from the

It is a process that starts with detailed need analysis and

scientific and ethical perspective," states Gandhi. After

ends with comprehensive training. Otherwise, the whole

identifying the needs, it is necessary to prioritise and

initiative will backfire and may result in the orgnisation

submit them to the authorities to sanction the required

becoming IT averse.

budgets.

(This article was published in Express Pharma)

"There is not much problem in getting the budgets sanctioned, as the extras that might be needed, extra computers or the renewals, are always taken into account," explains Babu. Once the budgets are sanctioned and resources (both hardware and software) are made available, it is necessary to train people and monitor the progress and status of prioritised IT projects. The most important part of any IT implementation is the choice of vendor. "I assume that all the global software providers have their basics in place, in terms of 21 CFR compliance, audit trials and business continuity plans," clarifies Ginde. "So what differentiates one player or an

THE INVESTMENT MADE BY CLINICAL RESEARCH ORGANISATIONS CAN RANGE FROM RS 50 LAKH FOR BASIC SYSTEMS TO A FEW CRORE. HENCE, ANY KIND OF IT IMPLEMENTATION NEEDS TO BE BACKED BY SOUND THINKING AND A COMPELLING REASON.

offering from another is that there are other parameters like the ease of standardisation, robustness, availability of reports at a click of the button and smoothness of processes using that particular software," he further adds.

Pride of Pharma- 2008

T AMIL N ADU HONOURS

✦ DR.REDDY’S ✦ NATCO ✦ MATRIX LABORATORIES ✦ DIVIS ✦ AUROBINDO ✦ BHARAT BIOTECH Please note that “The Top Six” is not a rating. The order is random and does not reflect any ranking.

A G LANCE

AT INDIVIDU AL COMPANIES WHO ARE DRIVING

T H E P H A R M A C E U T I C A L I N D U S T R Y IN

ANDHRA PRADESH Pride of Tamil Nadu 2008

T HE T OP S IX

Dr. Reddy’s

Robust Growth

Dr.Reddy’s Laboratories, a vertically integrated pharmaceutical company has created a brand which is synonymous to robustness. Its strong portfolio of businesses, geographies and products have gives it an edge in an increasingly competitive global market. Starting Q2 FY09, in line with best in class reporting practices, the global pharmaceutical company with presence in over 100 countries changed its financial reporting from USGAAP to IFRS. Its overall revenue was at Rs. 16.2 billion ($348 million) in Q2 FY09 as against Rs. 12.5 billion ($268 million) in Q2 FY08, representing a growth of 30%. The operating income

“

was at Rs. 2 billion ($43 million) in Q2 FY09 as against Rs. 1.1 billion ($24 million) in Q2

THE COMPANY’S REVENUES FROM PSAI INCREASED BY 10% TO RS. 4.8 BILLION ($104 MILLION) IN Q2 FY09 AS AGAINST RS. 4.4 BILLION ($95 MILLION) IN Q2 FY08. DURING THE QUARTER, THE COMPANY LAUNCHED 35 NEW GENERIC PRODUCTS, FILED 24 NEW GENERIC PRODUCT REGISTRATIONS AND FILED 21 DMFS GLOBALLY.

”

FY08, representing a growth of 78%. Revenues from Global Generics business was at Rs. 11.2 billion ($240 million) in Q2 FY09 as against Rs. 8.0 billion ($172 million) in Q2 FY08. YoY growth of 40% was driven by key markets of North America, Russia and Germany. Its revenue growth of 54% in North America was driven by a combination of volume growth in key existing products, new product launches in the last 12 months and acquisition of Shreveport facility. Revenue growth of 68% in Germany; the growth was primarily driven by volume growth and one time sales of in- licensed vaccine. Revenue growth of 36% in Russia was driven by key brands of Nise, Ketorol and Cetrine. The company’s revenues from PSAI increased by 10% to Rs. 4.8 billion ($104 million) in Q2 FY09 as against Rs. 4.4 billion ($95 million) in Q2 FY08. During the quarter, the company launched 35 new generic products, filed 24 new generic product registrations and filed 21 DMFs globally.

Pride of Pharma- 2008

T HE T OP S IX

NATCO

Innovation Unlimited

Couple of months back, NATCO Pharma launched its first nano-technology drug – Albupax. Albupax is the first generic version of the international brand – Abraxane - of Abraxis Bio-sciences, USA. With this and many more in the kitty, it is evident that the company is becoming more innovative and active than ever.

Hyderabad based NATCO Pharma Limited had recorded an increase of 26% in its earnings for the 2nd quarter of fiscal 2009 (Rs. 114 Crores) over the same quarter last year (Rs. 90

“

Crores). The net profit for the quarter, after tax, at Rs. 1187 lakhs, also recorded an

CONSISTENTLY RANKED AMONG THE FASTEST GROWING PHARMACEUTICAL COMPANIES IN THE COUNTRY, NATCO IS UTILIZING ITS COLLECTIVE EXPERIENCE TO KICKSTART ITS FUTURE PLANS AS A GLOBAL COMPANY.

” 24

increase of 12% over Rs. 1057 lakhs for the same quarter last year. The Company has also received approval from the Drug Controller General of India for commencement of Phase I clinical trials for its new chemical entity which has multiple oncology indications. The clinical trials are expected to commence in November, 2008. Consistently ranked among the fastest growing pharmaceutical companies in the country, Natco is utilizing its collective experience to kickstart its future plans as a global company. NATCO PHARMA was promoted by Mr. V.C. Nannapaneni in the year 1981 as a Private Limited Company to be in the business of Research, Developing, Manufacturing and Marketing of Pharmaceutical Substances and Finished Dosage forms for Indian and International markets. NATCO PHARMA began operations in 1984 in Andhra Pradesh

Pride of Pharma- 2008

T HE T OP S IX

Matrix Laboratories

Enterprise of Strong Vision

With about 2000 employees, including over 200 R&D scientists, Matrix Laboratories conducts research & development, and manufacture products at the company's cGMP facilities located near Hyderabad and Visakhapatnam, India. The company's Solid Oral Dosage Forms facility is located near Nashik, about 150 km from Mumbai.

Matrix Laboratories posted a Net Sales (unaudited) of Rs 51439 lakhs for the quarter ended 30th September 2008. Total including other Operating Income was at Rs 52249 lakhs.

“

THE REVENUE FROM FINISHED FORMULATIONS GREW FOUR FOLD PRIMARILY ON ACCOUNT OF LAUNCH OF ANTI RETROVIRALS (ARV’S) DURING FY08, AS WELL AS INCREASE IN MILESTONE PAYMENTS AGAINST CONTRACTS FOR DEVELOPMENT OF FINISHED DOSAGE FORMS.

” 26

The company had posted a Net Sales of Rs.9386.33 Mio for the year ended 31st March 2008, on a stand alone basis reflecting an increase of 25.3% over the previous financial year. Out of the total revenues, APIs (active pharmaceutical ingredients) accounted for 77% and FDFs (finished dosage forms) accounted for the balance. The profit before tax and exceptional items rose to Rs 1413.02 mio (by 31.4 %) reflecting the underlying strength in the business. The sales of API increased marginally over the previous financial year due to lower export realization caused by the appreciation of Rupee against US Dollar by about 12%, by increased price pressures, and the increased use of API for captive consumption. The revenue from finished formulations grew four fold primarily on account of launch of Anti Retrovirals (ARV’s) during FY08, as well as increase in milestone payments against contracts for development of finished dosage forms.

Pride of Pharma- 2008

T HE T OP S IX

Divis

Proving Superiority Year-on-Year

Established in the year 1990, with Research & Development as its prime fundamental, Divis Laboratories focussed on developing new processes for the production of Active Pharma Ingredients (APIs) & Intermediates. The company in a matter of short time expanded its breadth of operations to provide complete turnkey solutions to the domestic Indian pharmaceutical industry.

Built on a 300 acre site at Hyderabad (Unit-I). the plant comprises of 13 multi-purpose production blocks and has space for further growth and expansion. Divis Laboratories set up

“

its second manufacturing facility at Visakhapatnam (Unit-II). in the year 2002 on a314 acre

FINANCIALLY, DIVI’S LABORATORIES EARNED A PAT OF RS.135 CRORES ON A CONSOLIDATED BASIS FOR THE SECOND QUARTER ENDING 30TH SEPTEMBER, 2008. TOTAL INCOME FOR THE QUARTER GREW BY 36% TO RS.333 CRORES.

site. The site has 7 multi purpose production blocks. Both the facilities are primarily engaged in the manufacture of Active Pharmaceutical Ingredients (APIs) & Intermediates for Generics. Financially, Divi’s Laboratories earned a PAT of Rs.135 crores on a consolidated basis for the second quarter ending 30th September, 2008. Total income for the quarter grew by 36% to Rs.333 crores. For the corresponding quarter of last year, the company earned a PAT of Rs.91 crores on a total income of Rs. 245 crores. For the current half-year, Divi’s earned a PAT of Rs.230 crores on income of Rs.600 crores as against a PAT of Rs.156 crores and income of Rs.475 crores during the corresponding

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previous half-year.

Pride of Pharma- 2008

T HE T OP S IX

Aurobindo

A Quantum Leap into Formulations

When it comes to pharmaceuticals, there is a delicate harmony of contemporary R&D and of care. There are very few who can maintain this harmony that involves calm in silence. Aurobindo Pharma has the rare charm of creating unique crafting of care with complete patience.

PV Rama Prasad Reddy, Chairman, Aurobindo Pharma

Becoming a public venture in 1992, Aurobindo Pharma, headquartered in Hyderabad, India, manufactures generic pharmaceuticals and active ingredient and reported a gross annual sales of Rs 25.5 bn in FY07-08 Today, among the largest ‘Vertically Integrated’ pharmaceutical companies in India, Aurobindo has a large and diversified product portfolio

“

spread over major product areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics, Gastroenterologicals, Anti-Diabetics and Anti-Allergic with approved manufacturing facilities

EVEN WITH INCREASED SPOTLIGHT ON AFRICAN NATIONS, THE COMPANY IS ALSO AGGRESSIVELY MOVING FORWARD IN CANADA AND AUSTRALIA TOO WITH 12 DOSSIERS FILED IN CANADA (4 APPROVED) AND 7 DOSSIERS FILED IN AUSTRALIA.

by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-Brazil; and has a global presence with its own infrastructure, strategic alliances, subsidiaries & joint ventures. Aurobindo Pharma today has emerged from being a leader in active ingredient segment to venture into regulated market formulations backed by its own R&D setup. The company’s de-risked business model allows for multiple revenue streams directed towards formulations, active ingredients and intermediaries, dossier licensing and contract manufacturing. It has also created diverse avenues though Therapeutics (300+ products spread across 6 major segments: CVS, CNS, GI, ARV, Anti-infective and others) and Competitive Technologies especially in sterile injectables. The model also allows for

” 30

technologies directed speciality formulations know-how and expertise in complex chemistry. The model also looks at geographic spread especially in regulated markets, BRIC economies and Row as well as worldwide participation into ARV business.

Pride of Pharma- 2008

has been actively involved in Associated Antivirus (ARV)

Business Opportunities

research and has offered extensive support to PEPFAR There has been a quantum leap in formulation sales of Aurobindo with 39 per cent (Rs 10 bn) of revenues from the business in the FY08.

Rs 2359

company has the largest generic product basket in the segment with 23 ARV ANDA approvals from USFDA and its

Formulations sales break-up FY07-08 : USA

(President’s Emergency Plan for AIDS Relief). The

25 products were included in WHO pre-qualification list.

Europe

ARV

RoW

Total

Rs 2011

Rs 4044

Rs 1634

Rs10048

The ARV formulation sales touched Rs 4 bn in FY08 (41 per cent year-to-year growth) and Aurobindo is looking at aggressively pursuing registrations in 45 countries.

Rs in Million Increased spotlight on the African nations, especially In USA, the company has now established relationships with key chain stores, wholesalers, distributors and other distribution channels in the US and has filed more than 140 ANDAs (Abbreviated New Drug Application). Its Cephazone US has launched its first product and is awaiting more approvals. The company is gaining critical base in US market by expanding its product basket with 39

South Africa (over 30 approvals from MCC SA) and the licence to sell Stavudine and Didanosine ranges of products in Africa, along with existing Efavirenz fills up important gaps in its model. the company is also aggressively moving forward in other regulated markets such as Canada and Australia too with 12 dossiers filed in Canada (4 approved) and 7 dossiers filed in Australia.

products already launched. Key products approved in FY09 include Zaleplon Cap (CNS), Aledronate Sodium Tab (Osteoporosis), Losartan Potassium Tab (CVS), Rispiridone Tab (CNS). It has also acquired a manufacturing facility in New Jersey. Aurobindo has also been ramping up its European presence.

Infrastructure It has one of the largest generic formulations and Active Ingredient R&D setups in India with 3 research centers spread over 16000 sq meters and a pool of 700 scientists. Aurobindo has significant R&D having contributed to 2300

The company has forayed into the European market

filings and dossiers worldwide. It is associated with UNO

having acquired Milpharm in UK and Pharmacin in

for development of Pediatric ARV formulations. Aurobindo

Netherlands with 100 MAs (Marketing Authorisation) each

has 14 state-of-the-art large manufacturing facilities; ten

and around 70 IPRs from TAD in Italy, in its effort to

in India, one in China, two in USA & one in Brazil.

penetrate in these markets. The company is augmenting European operations through Malta and its sales have

Business Outlook

touched Rs. 2 bn in FY08 (57 per cent year-to-year

Having made timely long-term investments the story of

growth).

Aurobindo is gradually unfolding and the company is

The company is now poised to capitalise on the growing anti-AIDS opportunity; over 50 million people globally are infected with the HIV virus. With most patients still untreated, its participation in tenders sponsored by WHO, US President’s Emergency Plan for AIDS Relief and Medicines Sans Frontiers can be productive. It already has

poised for exceptional growth. With global leadership in anti-infective to becoming the largest generic basket in ARV the journey have been immensely triumphant and today the company is surely moving closer to becoming Asia’s leading and among the top 15 generic global pharma companies by 2015

500+ anti-AIDS drug registrations in different countries. It

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T HE T OP S IX

Bharat Biotech

Committed to R&D of Vaccine and Biotherapeutics Bharat Biotech International is a leading producer of vaccines and biotherapeutics in India with a strong focus on product-oriented research and development. Established in the year 1996 by Dr. Krishna M. Ella & Mrs. Suchitra K. Ella, it is one of the largest manufacturers of INDIRAB® (anti rabies vaccine) in India.

Dr Krishna M Ella, CMD, Bharat Biotech

Bharat Biotech incorporates a strategic 3 dimensional business model with a solid emphasis on Biogenerics, Contract Manufacturing & Research, including introduction of novel products. This strategy since inception has enabled Bharat Biotech to achieve robust business growth,

“

both in the short and medium term, while maintaining its focus on developing novel patent protected products in the long term.

BHARAT BIOTECH IS THE FIRST BIOPHARMA COMPANY IN INDIA TO BE AUDITED AND APPROVED BY KOREAN FOOD & DRUGS ADMINISTRATION (KFDA) FOR THE MANUFACTURE OF AN INJECTABLE.

” 32

Research & Development, Product Pipeline, Partnerships Bharat Biotech’s goal is to build innovative technologies by attracting top of the class intellectual capital to research and help manufacture unique biopharmaceuticals and vaccines with global IPR associated along with the products. It has gained a number of patents in many vaccines and therapeutics product categories which demonstrate its consistent endeavor to bring novel health care products to improve the quality of life in the developing world. Going forward, Bharat Biotech’s new goal is to launch vaccines and therapeutics against life threatening Rotavirus diarrhea, Malaria, Japanese Encephalitis, Staph Aureus among many other diseases that cause worry globally.

Pride of Pharma- 2008

Products

REVAC-Bmcf - Thiomersol and Cesium Chloride free

Vaccines

Description

INDIRAB®

Anti Rabies vaccine, chromatographically purified,

Hepatitis B Vaccine New REVAC-Bmcf The First Vaccine in the World to be manufactured free of Thiomersol (Mercury) and Cesium Chloride. REVAC-Bmcf has been marketed and sold in

REVAC-B mcf®

BIOHIB®

Mercury free and Cesium chloride free Hepatitis B vaccine,

more than 30 countries worldwide with manufacturing and

Heamophilus Influenza B vaccine,

guidelines. The Vaccine has established an excellent safety

quality standards on par with USFDA, EMEA and WHO and efficacy profile since its launch 10 years ago.

COMVAC5®

Combination vaccine containing DPT+HepB+Hib,

REGEN-D - rh Epidermal Growth Factor for diabetic foot ulcers and burns

BIOPOLIO®

TYPBAR®

Oral Polio vaccine, monovalent and trivalent, Typhoid vaccine,

Bio-Therapeutics Description

rhEGF is biologically unstable, easily inactivated in presence of proteolytic enzymes and moisture. Compositions known in literature are unsuitable for industrial application due to poor shelf life. BBIL has designed a novel stable and patented formulation of rhEGF.

REGEN-D®

BIOGIT®

ZELECT®

Wound healing for diabetic foot ulcers, Burns, skin grafts,

REGEN-D has been tested and evaluated extensively in

Probiotic Yeast for antibiotic induced and travel lers diarrhea,

diabetic foot ulcers and burns.

Oral Rehydration therapy with Zinc,

be audited and approved by Korean Food & Drugs

human clinical trials and has proved its efficacy in treating

Bharat Biotech is the first bio-pharma company in India to Administration (KFDA) for the manufacture of an

Reaching New Milestones Successful Completion of its Phase I/II Clinical Trial

injectable. Product

Pipeline

Description

Status

for 116E Rotavirus Vaccine ORV 116E1

Oral rotavirus vaccine Phase II clinical trials

PvRII2

Malaria vaccine

Pre clinical studies

Lysostaphin

Anti Staphylococcus

Phase I-II clinical trials

Indian Rotavirus Vaccine Development Project (RVDP) this year announced encouraging results from a recent Phase I/II clinical trial of a live, natural reassortant, Oral Rotavirus Vaccine 116E (ORV 116E), which was developed

aureus Therapeutic

by BBIL. Rotavirus infections are the single largest cause of severe diarrheal disease among infants and children

Staph Aureus vaccine Anti Staphylococcus

worldwide and cause more than 500,000 deaths in infants

aureus vaccine

and children each year, with 90 per cent of these deaths occurring in the world’s poorest countries. Rotavirus diarrhea causes more than 120,000 deaths in India alone.

THR-1003

Novel variant of

Pre clinical studies

Phase II clinical trials

Staphylokinase, against heart attack,

Pride of Pharma- 2008

POLICY OVERVIEW

Partners in Growth

Pride of Pharma- 2008

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Caliber Technologies Pvt Ltd

Innovative Medical Solutions An untapped niche and a global opportunity, faith in the concept and confidence in the team were the drivers for the genesis of the company called Caliber Technologies Private Limited. Caliber is a successful, IT product based company, founded in 2001 with a focus on solutions for the pharmaceutical and biotech industries. Caliber established US operations in early 2008 to cater to the US and European markets, and it is getting an excellent response for its product offering. The company has taken big strides since its inception, a fact reinforced by the fact that it was selected in the Deloitte Technology Fast 50 companies in India and Fast 500 Sathya Sekhar Surabhi MD, Caliber Technologies

companies in Asia during the year 2008.

Caliber Technologies’ management team consists of

pharmaceutical and biotech companies comply with

experienced marketing, software development, and

stringent international regulatory norms like Electronic

finance personnel. The Company’s founder and CEO, Mr.

Signatures and Electronic Records (21CFR PART 11), GLP,

Sathya Sekhar Surabhi, has over 15 years experience in

GAMP, etc. Implementation of CaliberLIMS reduces the

related industry, with domain expertise to conceive and

risk of regulatory non-conformance. CaliberLIMS has been

develop products. Sekhar Surabhi, Founder, Managing

established as the market leader in Pharma industry in

Director and CEO, has over 20 years of experience in lab

India over the years. When the product is designed

management, instrumentation and software development

keeping in mind the highest standards required for the

for quality systems – a rare combination of expertise in

Pharma industry, it can be easily adapted to any other

three areas that are a key to success in the LIMS

industry application, while the converse is not true.

business. Mr. Surabhi also worked as COO of a software

Recently, Caliber successfully implemented its Caliber

company before setting up Caliber Technologies, adding

PetroLIMS in Bharath Petroleum, networking their 25

to his operational management experience.

laboratories with more than 1000 users across India in an

Caliber Technologies’ flagship product CaliberLIMSTM is designed using cutting edge technologies to help

unbelievably short time. This stands tall as a testimony to the technical supremacy of the product. CaliberLIMS is

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value addition. Caliber is among the very few companies worldwide, which have developed products on Internet technologies for regulated industries. CaliberLIMS is an effective tool for Enterprise Quality Management for regulated industries, with the capability to integrate various enterprise applications like ERP, SDMS/ECM, instruments and messaging services. CaliberLIMS being a 100% web technology based product from the design, adapting XML standards into LIMS can enhance the information in documents, simplify web automation, and integrate applications within or between organizations. Caliber has won acclaim for being the first known company in India to build its product (Caliber LIMS) in Microsoft web technology and for being the first known such product interfaced with enterprise wide systems like SAP. The product has impressive features: Caliber LIMS is currently a LIMS with the maximum number of ERP

modular, highly configurable and user friendly. It is simple

integrations in India and has been very successful in

to use and requires a short learning curve;

delivering value for money to the customers.

Implementation of Caliber LIMS requires minimal

CaliberLIMS SAP interface engine has been recently certified by SAP Global Certification center, as products that can be deployed effectively for extension of Quality Management (QM) functionality of SAP. CALIBER has earned the following crucial certifications: XI – Extended

customization; Maintenance and support is prompt and affordable; Updates and upgrades are readily made available through a maintenance contract; and remote maintenance capability reduces cost of maintenance and total cost of ownership.

interface through XML; EP – Enterprise Portal: allowing

While CaliberLIMS was developed following strict

Caliber LIMS to be fully integrated with SAP; and ESOA –

international standards and meets global compliance

Enterprise Service Oriented Architecture (Compatibility

regulations, the product is priced very competitively due to

certification completed). These SAP certifications will

its lower cost basis resulting from indigenous product

allow Caliber to aggressively sell its LIMS

development in India. Further, the cost of its

While there are lot of technology solution providers to Pharma/Biotech clients and the Petroleum Industry, we can confidently say that our technology solution is superior compared to other offerings in a number of ways. The technology used in building the product is highly advanced and has several advantages in terms of Total Cost of Ownership and recurring maintenance expenditure. Scalability and availability over the Internet are a great

implementation and customization is significantly lower compared to its competitors, even for multiple users at multiple locations of an organization. The domain expertise of its key personnel is what sets Caliber above the rest since they understand business processes in regulated markets and can translate any requirements quickly into solutions. Caliber also offers value-added services such as System Validation and Training for prospective users and managers. The Validation Service

Pride of Pharma- 2008

includes Installation Qualification (IQ), Operational

laboratories in oil and petrochemical industries; and

Qualification (OQ) and Performance Qualification (PQ),

Caliber CLAPS - the Controlled Label Printing System.

with specially prepared Qualification Protocols.

In the near future, the company plans to enter verticals,

Caliber has worked with Indian Pharma leaders as first

such as petrochemicals, food, agriculture and water

customers and their strong endorsement about the

treatment, by productising Caliber LIMS as “industry

product was instrumental in spreading its wings to other

solutions” for these verticals. Caliber is in the process of

places. Its customer support and quick turn around for

conceptualising and developing related products and

the enhancements has been highly appreciated. The

services. One example is Change Management and

Company holds an impressive list of clientele: Dr Reddy’s,

Deviation Management software and large scale

Aurobindo Pharma, Megawecare (Thailand), Unichem

Document Management system for the regulated industry.

Laboratories, Dabur Oncology, Dabur Pharma, US

Some of these products are already in Beta versions and

Vitamins, JBCPL, BPCL, Wyeth, Matrix, Ajanta Pharma,

undergoing live testing with some of our esteemed users.

NATCO etc.

Caliber’s vision is to establish itself as a key player in the

Caliber Technologies currently has three products,

pharmaceutical LIMS arena within the next 3 years,

CaliberLIMS with three variants: Enterprise - for multiple

especially in the US market. Caliber envisions itself

sites, Standard for single site and a lighter version

growing into a global company, with significant presence

Caliber-Expand for smaller companies. All these versions

in the developed markets of US and Europe, and a

are pre tuned for the FDA regulated pharmaceutical and

dominant presence in fast growing markets in developing

biotech industries; Caliber Pet-LIMS - the Laboratory

countries – where LIMS is starting to be incorporated.

Information Management System for the analytical

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IICT

Incorporating Science into Industry IICT, Hyderabad is a premier R&D Institute in India which 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.

Dr. J.S.Yadav, Director IICT

Indian Institute of Chemical Technology (IICT) has made significant contributions in the last six decades in that field and is now celebrating its Diamond Jubilee. Major

“

areas of research at IICT are: Natural Products Chemistry, Agrochemicals, Drugs &

CURRENTLY RESEARCH IS BEING CARRIED OUT AT IICT IN THE FIELDS OF NOVEL DRUG DELIVERY SYSTEMS FOR ORAL PEPTIDES / VACCINES AND DRUGS, PHARMACOKINETICS AND BIOEQUIVALENCE, DEVELOPMENT AND STANDARDIZATION OF IN VITRO ASSAYS FOR VARIOUS DISEASES AND ALSO PHARMACOGENOMICS AND GENOTOXICITY.

”

Intermediates, Speciality and Fine Chemicals, Fluoro-organics, Inorganic & Physical Chemistry (Catalysis & Material Science), Lipid Sciences & Technology, Coal, Gas & Energy, Chemical Engineering and Design & Engineering. IICT ’s basic objectives have always been to carry out research in the chemical sciences leading to innovative processes for a variety of products necessary for human welfare such as food, health and energy and the conduct of R&D work is fully geared to meet the requirements of technology development, transfer and commercialisation. Process development work, particularly for bulk chemicals is carried out at appropriate pilot plant scale to collect technological, economic and design data. With the help of excellent design & engineering expertise available, the Institute has been providing engineering designs for commercial plants with standard commercial guarantees. More than 150 technologies developed by IICT are now in commercial production. Its commitment to the Pharma industry is

Pride of Pharma- 2008

reflected by way of several sponsored and consultancy

institute being certified with ISO-9001:2000, from

projects received from the industry, year after year.

Germany adds another jewel to IICT’s crown.

With over 450 highly professional and dedicated scientists

Dr. J.S. Yadav, Director IICT, gave his views on the

and technical officers/technicians, excellent laboratory and

pharmaceutical industry. In lieu of the recent global

instrument facilities for research in chemical sciences and

economic crisis, he said, “The pharma market will surely

technology and allied sciences, IICT is known nationally as

be effected, but not to the extent as in the West. Though

well as internationally for its contributions both in basic

our exports make up only 2% of the world’s

and applied research.

pharmaceutical supply, our market will face some consequences since substantial part of our market is

IICT offers globally competitive and environmentally viable

export oriented”.

technologies for Drugs and Drug Intermediates, Organic and Inorganic Chemicals, Agrochemicals, Catalysts,

He also pointed out the other difficulties the industry might

Polymer Coatings, Adhesives, Oils and many other

have to face; he said, “Banking has become stringent,

technologies. IICT also offers wide-ranging knowledge

making it problematical for companies to acquire

based services in Analytical Testing and Characterisation,

industrial loans. As a result, the new industry growth will

New Molecule and Product development, Process Up-

be sustained”. Optimistically he added, “Overall, the

gradation and Re-standardisation, Process Safety studies,

pharmaceutical industry in India will be fairly isolated from

Design-Engineering and Project Viability studies.

the recession”.

The major activities carried out at IICT are: Pre-clinical

The Biotechnology Incubation Centre (BTIC) is the latest

toxicity (includes Acute, Sub-acute, and Chronic toxicity

feature of a collaborative initiative between Department of

studies); New Drug Discovery -Pharmacological screening

Biotechnology, New Delhi, Government of Andhra Pradesh

for arthritis, diabetes; Drugs &Cosmetics Testing for

and Indian Institute of Chemical Technology (IICT),

Finished Products according to IP, BP, USP, JP, etc;

Hyderabad to promote the advanced biotech business and

Pharmacokinetics and Bio-equivalence; and Novel drug

entrepreneurship in India.

delivery systems.

BTIC is established mainly to generate development of

Currently research is being carried out at IICT in the fields

huge human resources required for biotech and

of Novel Drug Delivery Systems for Oral Peptides /

pharmaceutical industries and for providing training in a

Vaccines and Drugs, Pharmacokinetics and

furnished and equipped laboratory with an international

bioequivalence, Development and standardization of in

environment.

vitro assays for various diseases and also Pharmacogenomics and geno-toxicity. IICT prides itself for its excellent test facilities in preclinical toxicity, in vivo and in vitro evaluation; its recognition by various universities for pursuing R&D studies leading to Ph.D; its approved testing laboratory for drugs and cosmetics; and its Publications in high impact

It also offers hand on practical training, proper handling of equipment, and scientific environment and management services for start up companies. The aim is to provide the complete infrastructure for those companies and make their thoughts into a reality with reduced upfront investment.

factor journals related to pharmaceutical sciences. The

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NIPER

Striving to Realise the Pharmaceutical Dream National Institute of Pharmaceutical Education and Research (NIPER) is the first national level institute in pharmaceutical sciences with a proclaimed objective of becoming a centre of excellence for advanced studies and research in pharmaceutical sciences. The Government of India has declared NIPER as an ‘Institute of National Importance’. It is an autonomous body set up under the aegis of Dept. Of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. The Institute is conceived to provide leadership in pharmaceutical sciences and related Dr. Prakash V. Diwan, NIPER Hyderabad’s Project Director

areas.

The National Institute of Pharmaceutical Education and Research at Hyderabad has been created as a centre of excellence for higher education, research and development in

“

pharmaceutical sciences. The Institute is located about 10 Km north of Hyderabad at

STARTING WITH M.S. (PHARM.), THE INSTITUTE PLANS TO INTRODUCE SPECIFIC AND INTERDISCIPLINARY COURSES IN PHARMACEUTICAL SCIENCES AND TECHNOLOGY. IN FUTURE THE NUMBER OF PROGRAMS WOULD BE INCREASED AND PH.D PROGRAMS WOULD ALSO BE STARTED.

”

Balanagar, on a total area of 150 acres. NIPER Hyderabad has been set up in the sprawling R&D Centre of IDPL (Indian Drugs and Pharmaceuticals Ltd) in Balanagar, Hyderabad. The campus has library, appropriate laboratories for Medicinal Chemistry, Pharmacology & Toxicology and Pharmaceutical Analysis, Cell culture lab, animal house under preparation. These laboratories are being strengthened and modernized to suit the present day needs. The lecture halls are equipped with modern gadgets of teaching. An auditorium, seminar halls and committee room also exist for conducting seminars and conferences. NIPER Hyderabad’s Project Director, Dr. Prakash V. Diwan gave an insight to the institute’s formation and formulation. He said, “Today India requires a lot of professional manpower in the pharmaceutical industry. The Pharma industry in India is still rapidly growing and we would like for it to stand on the global platform. Initially there was just one institute, NIPER

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Chandigarh established in Mohali, and the government felt

also be started in its various disciplines of pharmaceutical

the need for creating more institutes”. Originally the

sciences every year.

institutes were established in the selected cities of Hyderabad, Ahmedabad, Kolkatta and Hazipur, and were

The institute is encouraging all round development of its

started last year. Similarly from this year, they have setup

students. Dr. Diwan stated, “Each morning, students

campuses in Rai Barelli and Guwahati.

discuss the current affairs in science and technology. Along with this, every Friday or Saturday, direct industrial

Each institute/campus has its own specialisation subjects;

interactions take place with the students.”

Pharmacology, Toxicology, Medicinal Chemistry and Pharmaceutical Analysis are the core areas of industrial

Apart from these two concepts, they have also a dress

requirements. Dr. Diwan explained “These factors about

code for all the students. The dress code system helps in

the Pharma industry helped us choose the courses for the

eliminating any kind of social segregation and also instils a

Hyderabad centre. For starting off the institute, the

sense of pride towards the institute.

government introduced the concept of mentor institutes; the mentor for NIPER Hyderabad was chosen as IICT, the Indian Institute of Chemical Technology under the guidance of Dr.J.S.Yadav, FNA, FTWAS, Director, IICT. This mentor

Elaborating on his connection with his students, he said, “I try to keep a good relation with my students; I want my students to have overall wisdom and not just book knowledge.

institute was actually responsible for nominating the Project Director for the new institute, and they finally chose me to take up the responsibility”; Dr. Diwan took up the post in June 2007, and since then he has been continually working on setting up the infrastructure for the institute. Commenting on the first batch of students that were admitted to the centre, he said, “We started off with an initial batch of 41 students; these were B. Pharm graduates and their admission was through a two stage process: first a GATE score of 94.5% followed by JEE Merit List made them eligible to join a NIPER centre depending on their choice of specialisation courses”. Since the infrastructure setup is still in progress, NIPER took the help of its mentor institution IICT and also IDPL. Dr. Diwan explained, “Preliminary classes and laboratory work was being done at IDPL and IICT facilities, but slowly we are setting up all facilities here at the NIPER campus. This way we will not be burdening our mentor institutes”. Starting with M.S. (Pharm.), the Institute plans to introduce specific and interdisciplinary courses in Pharmaceutical Sciences and Technology. In future the number of programs would be increased and Ph.D programs would

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DCIT

Better Living Through Chirality Daicel Chemical Industries Inc, formerly known as “Dainippon Celluloid Company”, was established in 1919 through a merger of eight celluloid producers in Japan. Based on their expertise in celluloid chemistry, they have developed a variety of cellulose derivatives and brought them to the market over the years. Daicel has set foot in India and with products and services catering to both CROs and pharmaceutical companies, it is sure to build a solid foundation to rise up on.

Dieter Heckmann, Managing Director, Daicel Chiral Technologies India (DCTI)

Daicel was formed as a result of a merger of eight companies back in 1919; the Company was developed around the celluloid business. It was started as a means of acquiring the chemicals needed for celluloid and to also provide facilities for working with celluloid. Fuji

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Film was originally the photo film division of Daicel and was started off as a daughter

MARKETING, PROMOTIONS AND TECHNICAL SUPPORT ARE BEING HANDLED FROM THE HYDERABAD OFFICE. WE OFFER CHIRAL SEPARATION SERVICES, BY USING PREPARATIVE HPLC & SUPER CRITICAL FLUID CHROMATOGRAPHY (SFC).

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company of Daicel as a spin off back in the 1920’s. There are still a lot of links in Daicel’s business to celluloid: for example they produce films made of cellulose used for protecting food and also films of cellulose that cover and protect the liquid crystal displays in TV’s and computers. Another important area in Daicel’s operations nowadays is productions in pyrotechnics. These are being applied in the automobile industry for the deployment of safety air bags; the bags need to be explosively inflated at the time of impact. Using their existing knowledge of nitro-cellulose (as an explosive) Daicel started producing airbag deployment systems for Toyota and for other companies also. The know-how in dealing with explosives really helped them get into this industry.. Dieter Heckmann, Managing Director of Daicel Chiral Technologies India (DCTI), gave an insight to his company’s operations. He said, “Our department of Daicel also traces back to

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cellulose; our department of the chiral chromatography

analytical type, but with the formation of DCTI, both

has products based on stationary phases of poly-

analytical and preparative aspects are taken care of”.

saccharides, thus using cellulose as the base of our chiral selector. These products had been invented in the early 80’s by Professor Okamoto, who was looking for a partner to commercialise these products. So his expertise in polysaccharides got him interested in Daicel”. Though Daicel had no links with chromatography, its experience in handling poly-saccharides was helpful in forming that partnership.

The pharmaceutical industry of India was at a stand point that was very beneficial for the opening of the company here in the country. Mr. Heckmann explained, “We think our timing to go into the Indian market was perfectly right; we saw two developments: the first and most important one was, even the medium size Indian pharmaceutical companies, are moving towards development, so our products and services would be needed, and the second

Though the Company is global and has offices all over:

was the increase in CRO, Contract Research Organisation,

USA, Europe and Asia, Daicel’s main focus has always

activities with big multi national companies using India to

been on Japan and China. The manufacturing units of

outsource their research”.

DAICEL are located in China, Thailand, Poland and USA. To elaborate on the role Daicel Chiral India plays in the organisation, Heckmann said, “Daicel has an ‘Internal Company System’ and we are part of the CPI companies division. CPI stands for ‘Chiral Pharmaceutical Ingredients’, and so all products and services related to the pharmaceutical industry are concentrated in this division of companies. Principle processes incorporating CPI are Chromatography and Bio-catalysis of Enzymes”. He went on to say, “The share of Daicel India from the parent Company is still a small venture but is steadily growing”. To this, Lakshmi Narayana, Director-Technical of Daicel India, added, “The Indian Company started off as a liaison office for Daicel Chemical Asia of Singapore. Daicel Chiral Technologies India was formed in May 2008”. Before the formation of Daicel India, a network of distributors had been handling the supply of products in India for over 15 years. Commenting on the start of Daicel India, Heckmann said, “After the formation of the office, we are still using the same distributor network, maybe with some modifications; now what we are providing is the additional service. DCTI would not only supply technical support to the distributors and the final end users, but also bring in the preparative aspect of the business. Earlier the business was nearly 99% of the

Regarding the functioning of the chiral technologies facility set up in Hyderabad, Lakshmi Narayana commented, “Chiral Chromatography is very helpful for pharmaceutical companies, starting from drug discovery stage to the commercial production stage. Using our chiral columns, the success rate is very high”. To this Mr. Heckmann added, “Marketing, promotions and technical support are being handled from the Hyderabad office. We offer chiral separation services, by using preparative HPLC & Super Critical Fluid Chromatography (SFC). In addition, we offer a two day training workshop on ‘Practical Chiral HPLC method development’. Both CROs and pharmaceutical companies can avail of these services”. When asked about keeping abreast with ever-evolving technology, Heckmann stated, “The scientific principle of chromatography has basically remained the same throughout the advances in technology. So, to perform better in our processes, the facilities are constantly optimised for our existing products and we try to develop new products in this line.” On the choice of Hyderabad as their base; he said, “Hyderabad was chosen to represent Daicel as it has a high concentration of pharmaceutical companies and customers. Expansion plans of the current facilities in Hyderabad are being discussed”.

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Sristek

Perfect Blend of Research and Technology Sristek describes itself as a company that offers the best of Clinical Research Data Management & Statistical Analysis Services. The factors that have brought success to Sristek are mainly the quality of services that the company provides, its professional and well trained staff, robust SOPs & processes and the ability to quickly adapt to the changing needs of the client. Also, the management of the company has the right mix of people who have grown with the firm as well as people who have brought in years of experience in clinical research and data management.

As a Contract Research Organization (CRO), the services provided by the Company to the field of Drug Discovery & Development have a pleasant blend of research and technology. The services can be broadly categorized into the fields of Clinical Research Services &

“

Operations; Clinical Data Management; Biostatistics; and also Staffing Solutions.

THROUGH THEIR STAFFING SOLUTIONS, SRISTEK PROVIDES THE RIGHT-FIT’ PROFESSIONALS TO SUPPORT THE CLIENT THROUGHOUT THE CLINICAL RESEARCH, GLOBAL STANDARD OF SERVICE WHILE MAINTAINING ACCURATE SENSITIVITY TO LOCAL NEEDS, AND QUALITY CANDIDATES WORKING TO CLIENT-SPECIFIC STANDARDS.

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Sristek sources business from Global Pharmaceutical and Research companies, located anywhere in the world, that are interested in outsourcing their research and clinical data management activities. This could either be for the whole process or for parts of it. Sristek provides customized services depending on the requirement of the client. Sristek currently provides the following services under clinical research: ❋ Phase I - IV trials for Indian pharma and research companies, ❋ Feasibility Studies, Project Planning and Setup, ❋ Study Design and Protocol Writing, ❋ Regulatory Affairs & Ethics Committee Submission, ❋ Design & Development of CRF, ❋ Project Management,

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❋ Site/Investigator Identification and Selection,

Asia. The services provided to these clients can be

❋ CRA/CTA/Site Coordinator Outsourcing

customised according to the requirements of the client.

❋ Site Monitoring, Site Management,

The Company has strategic alliances with many leading companies across the world. These alliances allow Sristek

❋ Clinical Data Management

to gain entry into more specialised services, thus

❋ Biostatistics & Clinical Programming

expanding its scope of services offered.

❋ Quality Assurance/Audit Services,

Sristek is setting up Sristek Academy of Clinical Research

❋ Medical Writing

(SACR) that will provide training in all aspects of clinical

❋ Staffing Solutions

research, clinical data management and Biostatistics. The

Drug development requires enormous resources. Recognizing the need to manage and meet the clients’ resource needs, Sristek created the staffing solutions model, a flexible service program. Through their Staffing Solutions, Sristek Provides the Right-fit’ professionals to support the client throughout the clinical research process,

main aim behind setting up a Centre of Excellence for training and education in Clinical Research is to create an environment where clinical research professionals in India can be trained in the activities of Clinical research. The Academy will be offering 2 courses to start with- A PG Diploma in Clinical Research and a PG Diploma in Clinical Data Management and Biostatistics. The Academy will be the result of a collaborative effort between Sristek

Sristek has worked with over 50 clients that include big

and major players from the Indian pharmaceutical &

and small pharmaceutical companies as well as other

hospital industry.

CROs. Their clients are located in the US, Europe and

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MakroCare

‘Caring’ for the Life Sciences Industry MakroCare, a division of Makro Group, is a global clinical research organisation providing functional services to pharmaceutical, biotechnology and medical device industries. MakroCare owes its success to employing the most appropriate and latest technologies in clinical research and to accuracy with which it operates. Mahesh Malneedi, MD, MakroCare

MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries. It offers major services such as - site selection, patient recruitment, project management, clinical data management, biometrics, statistics, clinical monitoring, medical writing, medical Communications, post

“

marketing surveillance/pharmacovigilance, quality assurance and regulatory Affairs.

MAKROCARE OFFERS UNIQUE AND COMPREHENSIVE FLEXIBLE BUSINESS MODELS AS A MUST-HAVE SUCCESSFUL BUSINESS MODEL BY RENDERING NOT ONLY COSTEFFECTIVE BUT ALSO SOPHISTICATED AND HIGHLY EFFICIENT QUALITY SERVICES AND SOLUTIONS TO THE PHARMACEUTICAL, BIOTECHNOLOGY AND MEDICAL DEVICE INDUSTRIES.

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MakroCare is a privately held company with its main offices in USA (New Jersey, Illinois, and Pennsylvania), Europe (Frankfurt) and India (Hyderabad). MakroCare has vast experience in therapeutic areas like cardiology, endocrinology, gynaecology, neurology, oncology, ophthalmology, CNS and pulmonary medicine. MakroCare is known for its functional module outsourcing approach for clinical research services, which is a unique and innovative approach to meet client’s needs in support of their clinical trials management. The company has several Life Sciences clients including 5 of the top 10 firms in the world. They offer customised business models to their clients appropriate for the specific service that is being performed, keeping in mind the tactical and strategic nature of the services. MakroCare has several alliances with other firms in Europe to bring local expertise to clients that plan to expand in that region. Apart from these alliances, they have professional

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alliances with DIA, ACRP, SoCRA, SAS and other

methods and tools. Regardless of location, MakroCare

organisations.

ensures consistency of process via global access to their

Apart from clinical services, MakroCare brought additional related services to the industry and grouped them in technology and consulting categories. The company brings

knowledge driven technology management system. MakroCare also offers Full Time Equivalent (FTE) engagement models to meet their client’s needs.

in several technologies to the clinical and Life Sciences

MakroCare recently organised a Workshop on

industry such as CTMS, CDMS, EDC, patient diaries, and

Pharmacovigilance at the Nizam’s Institute of Medical

EDMS, and undertakes full cycle implementation to support

Science in Hyderabad, bringing to fore the importance of

these technologies. As part of consulting, the company

pharmacovigilance in clinical trials and a workshop on GCP

offers services in terms of product development strategy,

at MakroCare India office. MakroCare also sponsored

in/out licensing planning, regulatory strategy for different

momentous to the delegates of the Annual Conference of

countries, exploring funding opportunities and other value-

the Indian Society for Medical Statistics (ISMSCON ‘2008)

added consulting services to Life Sciences clients.

held in November at Nainital is one among the few to

MakroCare services ensure adherence to Quality and GCP/

name in national and international level events and

GLP requirement. It has customized and adapted good

conferences.

project management principles from PMI and ITIL standards.

Apart from bringing in new jobs to AP, MakroCare is bringing in the proven business practices, latest

The company offers unique and comprehensive flexible

technologies, and best-of-the-breed project management

business models as a must-have successful business model

principles from USA and Europe to local companies.

by rendering not only cost-effective but also sophisticated and highly efficient quality services and solutions to the pharmaceutical, biotechnology and medical device industries. The also offers offers a functional outsourcing approach for clinical research under which they contract and deliver a particular service to meet their client’s needs in support of all their clinical trials; they are often referred to as the one-stop shop. Their Onsite/Offsite services reflect their ability to deploy highly skilled professionals at a facility to handle clinical challenges. MakroCare works to identify the services that can streamline a clinical operation and reduce its costs while positively impacting clinical development. The offshore outsource delivery model is flexibly designed to reduce costs, maintain high quality standards, along with the integration of world-class project management,

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Winmax

The Worthy Vender called Winmax

In the current scenario it is reliability and sophistication that is needed to be in the live market. It is a hard task to be practiced for survival and Winmax is game for it.

T S Jagannathan, Chief Exective, Winmax Enterprises

Winmax was started way back in 1989-90 as a Dealer of “Remi” Motors. By 1992-93 it was a supplier of machinery in Processing & Packaging for Pharmaceutical, Food and Liquor Industries in association with growing machinery manufacturers like Machin Fabrik, Amba Engineers, Bectochem Engineers, Kothari Pharma, Satellite Engineers, and Marvel Machines etc. basically catering to simple machinery of semi automatic nature.

“

WITH AN INCREASE FROM RS. 30 LACS TO RS. 5 CRORE IN TURNOVER SINCE THE YEAR 1990-91, WINMAX IS CURRENTLY ESTABLISHING ITS OWN MANUFACTURING UNIT STARTING WITH A LAB MODEL MACHINERY OF GMP STANDARDS.

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With the growth of the pharmaceutical industry during the nineties, Winmax added machinery for sophisticated and more automated technology driven areas. This included PLC controlled machinery giving the much needed data generation & control of processes leading to high end validations. This was necessitated by the outsourcing of drugs and formulations by International Companies looking for WHO, UKMHRA & USFDA Standards. Along side these machines, Winmax also developed for local manufacturers, value added products like Micropulverisers, Mass Mixers, Tray Driers, Stirrer, Vessels, and Belt Conveyors etc. to fill up the growing needs. They cater to Ayurvedic, Homeo & Unani based Indian Medicine Manufacturers apart from small Allopathy Manufacturers. With quality products and uninterrupted post-sales services provided, Winmax established itself as a reliable supplier of machinery; they have spread operations to Tamil Nadu and have established their name with credibility. Winmax has customers in all areas of manufacture since the machinery they offer covers the total range of dosage forms like Orals, Injectables and external usage products.

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INKARP

Equipping the Pharma Industry INKARP Instruments Pvt Ltd is one of the most reputed organisations involved in the business of supplying analytical instruments and consumables to the medical and pharmaceutical industries. Headquartered in Habsiguda, Hyderabad, the company has offices in 14 cities in India and caters to the requirements of its clients across the nation.

S. Balu, CMD, INKARP

INKARP represents leading manufacturing companies from Europe, USA and Japan on an exclusive basis . The product line includes basic lab equipments, instruments for drug discovery, life sciences research and consumables for chromatography products.

“

“WITH THE PHARMACEUTICAL BUSINESS GROWING IN HYDERABAD, OUR PRODUCT MIX ALSO EXPANDED AND TODAY WE ARE ONE OF THE MAJOR SUPPLIERS OF QUALITY INSTRUMENTS TO THE QUALITY CONTROL AND R&D ACTIVITIES OF ALL PHARMA & BIOTECH COMPANIES IN THE COUNTRY”. - S BALU, MD, INKARP

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The business was started off in 1985 by S. Balu, Chairman & Managing Director of the company, who has since grown the business multi-fold over the last two decades. Balu gave an insight to his company’s beginnings. He said, “I started this business way back in 1985 as a sub agent, supplying various brands of analytical equipments to customers like NIN, IICT, CCMB, Osmania University etc”. Commenting on the growth of the company he said, “With the pharmaceutical business starting to grow in Hyderabad in a big way, our product mix also expanded and today we are one of the major suppliers of quality instruments to the quality control and R&D activities of all pharmaceutical & biotechnology companies in the country”. On the performance of INKARP, Balu stated, “We have built long standing relationships with all the principals that we represent and this is evident from the fact that some of these relationships are completely exclusive and are more than 2 decades old. Plans are also

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underway to establish Joint ventures with some of our

While the analytical instruments business continues to be

principals to service customers in the Asian sub continent

the mainstay of INKARP, the company has diversified into

– one such joint venture has just been established”.

the telecom business sector, with a goal to become an

To keep the company ever evolving, changes and

‘end-to-end convergence solutions providing company’.

improvements have been made in INKARP’s operations.

This is an independent business unit and will be operating

Today the company has transformed into a Private Limited

out of Chennai. Along with this diversification, INKARP has

company with more than 120 dedicated staff members

also incorporated some expansion to its current

and a committed leadership team to drive the

functionality. To cater to the emerging healthcare market,

organization.

the company has recently started a diagnostics business

Balu explained, “To improve our support to customers and also to enhance our own performance, we have recently

unit, with the aim of offering cost effective instrumentation and services to pathological labs.

implemented Customer Relationship Management

Asked about the success of INKARP, Balu said “I attribute

Program, with all our regional offices being linked to a

our success to our staff at INKARP, our customers and our

central server located in Hyderabad”. He proudly went on

Principals, all in equal measure. I am really pleased to see

to say, “The Company has an advisory council that guides

our company grow over the years and as we close in on

our business strategies and also helps us review our

our 25th year of successful presence, we hope to cross

product mix so as to offer newer products and services in

several milestones to come”.

line with the current and future needs of the market”.

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IClean Technologies

Quality and Innovation… hand in hand IClean was established in Hyderabad in 2002 as a clean room manufacturer for the pharma industry; since its inception it has fast grown as India’s leading clean room manufacturer with in house capabilities for product design, installation and development.

K. Gopi, MD, IClean

“Integrated Clean Room Technologies (IClean) was initiated utilising their pharmaceutical background and experience. Back in 2003, the company’s operations were basically to

“

import clean room utilities”, said K. Gopi, Managing Director. In this process, equipment cost, project timelines and knowledge of Indian requirements were the main

THE COMPANY HAS BEEN WITNESSING A 60-70% GROWTH WITH EACH PASSING YEAR. WE ARE SETTING A TARGET OF RS. 50 CRORE IN TURNOVER FOR THIS YEAR AND HOPE TO ACHIEVE RS. 10 CRORE BY THE YEAR 2010

complications. Therefore IClean took up the task of developing and producing clean room equipment indigenously in the country. In doing so IClean has been able to provide fast and cost effective services that adhere to Indian standards. Gopi said, “In April of 2008, we started a third production unit which enabled us to triple our capacity and increase our productions from 1 lakh sq mtrs to 3 lakh sg mtrs. Now we have a total of 1.3 lakh sq ft. of area for our operations”. The role of clean rooms in core segments like Pharmaceuticals, Biotechnology and Microelectronics is of vital significance. Since these industries require the perfect environment to operate and function, clean rooms need to subscribe to the most stringent quality norms and display

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consistent performance and long term utility. Gopi stated, “Right from manufacture and supply of clean room materials to installation and customising our product range to suit

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varying needs of our customers, we spare no effort to

companies seem to attract customers but disappoint since

ensure that we deliver the best in terms of quality and

they do not completely understand the customers’ needs.

service”.

Our on time delivery models, ‘Fast Track Projects’,

The products include metallic wall and ceiling panels with PUF and rock-wool insulation; air handling units; lab furniture; fume cupboards; laminar flow stations; and pass boxes etc. manufactured to custom builds and finishes. “We have forayed into new fields of production.

economical and high quality equipment combined with our better understanding of the customer requirements have been the cornerstones of our success; we have managed to create a loyal clientele that order products from us regularly”, said Gopi.

Added to our product line of clean room equipment and

The Company’s mission is to incorporate innovation in its

accessories, are air handling units and lab furniture. We

processes to improve quality and increase capacity. Apart

also plan on taking up HVAC clean room projects in about

from the domestic Indian Pharma market, they also export

3 months. These new products will require the same

clean room equipment to places in Europe, Africa and

expertise and facilities that we currently maintain, which

Asia: Greece, Cameroon and Yemen to be precise.

make it a smooth transition”, added Gopi. They have also recently ventured into the new market segments of semiconductors, hardware, food and solar cell manufacturing. The systems incorporated in IClean’s productions are all ISO 9001-2000 certified and approved, and their products comply with stringent international standards. IClean holds an edge in the industry market thanks to the superior quality of its products, its better understanding of customer requirements from the concept to the hand-off stage, and its ability to deliver to the customers on time. Gopi explained, “Our powder coating facility is probably the most advanced in India and our company is one of the largest Clean Room suppliers in the nation with possibly the widest range of products on offer. All this has been possible because of our own research and development team”. Quick turn-around time, the ability to precisely address each of our customer’s specific requirements and a preoccupation with quality has earned IClean an enviable client list. Fully computerized, state-of-the-art infrastructure, equipped with CNC machines is perfectly geared to cater to the varying requirements and

“Our core strength comes from the fact that we constantly innovate and create newer and better products that add value to our customers’ business. This, coupled with a core management team with a wealth of experience, a Best Practices driven strategy and stringent Quality norms has enabled us to compete successfully in a growing market”, expressed Gopi. IClean has no partnerships or alliances as such, though they do work with independent consultants to assist them in their performance. The Company is centrally located in Hyderabad with Sales representatives in Mumbai and Chennai. Commenting on the recent economic meltdown, he said, “The global recession has not altered our performance in the industry. The last 2 months have actually seen higher production and we have maintained production levels for the past 5 years”. Regarding the company’s performance, Gopi added, “The Company has been witnessing a 60-70% growth with each passing year. We are setting a target of Rs. 50 crore in turnover for this year and hope to achieve Rs. 10 crore by the year 2010”.

specifications of customers. “In the industry, new

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Ishida India

Weighing their options well

Since the beginning of the year 2000, when India became a focus of attention as a member of the emerging ‘BRICS’ economies, demand for Ishida’s high speed weighing and packaging, inspection and detection systems has increased rapidly. Using innovative technology, it has quickly carved a niche for itself in a diversified market segment.

Takayasu Yamada, MD, Ishida India

As food consumption, medicines and food supplements continue to grow explosively, food makers and pharmaceutical companies are expanding their facilities to boost production for meeting demands of both domestic consumption and exports. Although the main customers in India were initially snack producers almost exclusively, customer in other product

“

categories including pharma, engineering and other industrial products have also increased. Against this back drop, sales of Ishida products have registered annual growth of 150% in

ISHIDA INDIA’S SALES IN THE MARKET FOR 200809, THEIR FIRST FULL YEAR OF OPERATIONS, ARE EXPECTED TO BE AROUND 35 CRORES; THE TARGET SET BY ISHIDA IS TO GROW BY 40 PER CENT EVERY YEAR.

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recent years. Demand for after sales service has also grown. Ishida India was established in 2007 to ensure that their customers in the burgeoning Indian marker are satisfied with Ishida products and for them to be ready to respond to the customer requests by building relationships with the customers. The main focus of operations since its inception was to establish the sales and service organisation, which Ishida has completed successfully. As far as products and services are to be considered, Ishida aims at being preferred vendors to the Food, Pharma and other industries where in the products fit-in. They also aim to be a one stop shop for all weighing needs in these segments. The product line includes Multi-head weighing scales which can be used for as low as 5 to 10gms packaging up to 10kgs depending on the production capacity of customers and high speed Vertical form fill seal machines apart from rotary bag makers. To continue along the production line they have detection systems such as Metal Detectors and X-ray

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Inspection Systems; Tablet counting and filling machines

companies have been supplying Tablet counting machines

are exclusively made by them for the Pharmaceutical

in India for a long time. The other segments they cater to

companies.

include snacks, confectionery products, frozen foods, and

Recently they have installed over 200 such machines in the Pharmaceutical Companies in Japan. Completing their

dairy products, ready to eat products, chemicals and Engineering industries.

product basket are Analytical and Precision balances and

A fully equipped demo station with Multi-head weighers,

weighing scales ranging from 3kg to 3000kg. Ishida builds

packaging machines, X-ray inspection system and

their equipment understanding that it has to work 24 x 7

Checkweighers is used for state of art demos for actual

with very minimal scope for break-downs. Most of their

trials on various customers’ products. They are also

equipments are user friendly and modular.

introducing a host of training programmes for hands-on

Ishida’s innovation has helped it develop a Complete Stainless steel ‘Checkweigher’ DACS-G, which is modular in design and very competitive. Ishida, being an expert in Checkweighing Technology with over 35 years experience, this new model DACS-G (ranging from 2 mg to 60kg) is going to be released in the market in the coming months. Ishida’s position in the pharma industry is not yet strong; they have just launched their machine while other

training on these equipments. Ishida’s global reach is strengthened by its world-wide alliance with Heat & Control which is a global giant in manufacturing food processing equipments for the Food Industry. This strategic alliance has been since 1983. In India, they have their office and Factory at Chennai and handle the snack and confectionery segment for Ishida. Ishida is looking at a similar strategic alliance for tablet counting and filling machines.

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Ecobliss

Packaging Efficiency Ecobliss has been in the business of providing innovative packaging solutions over a decade by now. Ecobliss designs, develops and manufactures a wide range of blisters and other high visible products. And it caters to the requirement of FMCG, Pharmaceutical/ Health care, cosmetics, Electrical/Electronics, automobile components, food/ agriculture and a host of other segments as well. AVPS Chakravarthi, MD, Ecobliss

It only takes seconds for a consumer to notice a product on the store shelf. That moment

“

presents an incredible marketing and selling opportunity. Nearly 70% of all purchase

ECOBLISS PROVIDES FOR THE PHARMACEUTICAL SEGMENT A CUSTOM MADE INTELLIGENT PACKAGING SYSTEM THAT EDUCATES AND INTERACTS WITH PATIENTS AND CONSUMERS THEREBY PLAYING A CRUCIAL ROLE IN HEALTHCARE PRODUCT DEVELOPMENT AND MARKETING.

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decisions are made at the shelf. Nearly half of all packaged goods are sold without any additional marketing support. Packaging is therefore essential in capturing that ‘first moment of truth’. The new generation patented cold seal packaging system which was invented by Mr. Ron Linssen (the founder and Managing Director of Ecobliss, Netherlands) has been in use across the globe by now. Pharmaceutical and healthcare segment is the one which makes use of this concept more than any other segment. In the pharmaceutical & healthcare industry, blister cards and blister wallets are commonly used for clinical trials, drugs promotions and commercial packaging as well. The advantage of using blister wallets as secondary packaging for drugs is that the product information always stays with the drug itself, unlike the case of folding boxes where the information

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about the drug is often lost after separating the blister

Ecobliss operations are headed in India by AVPS

strip from the box.

Chakravarthi (Managing Director of Ecobliss Pvt Ltd.), who

Pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. These changes have made a big impact on the packaging industry and there is an increasing need to provide tailored, individual packaging solutions, which guarantee the effectiveness of medicines. Due to degradation from environmental factors, such as light and humidity, there is often a direct link between packaging and a remedyâ&#x20AC;&#x2122;s effectiveness. During the design phase, Ecobliss keeps in view all these packaging needs of its customers, and also the changing child resistant requirements and legislation for commercial and clinical blister packaging throughout the world as well. Ecobliss provides for the pharmaceutical segment a custom made intelligent packaging system that educates and interacts with patients and consumers thereby playing

has around 25 years of experience in paper, printing and packaging businesses. He has extensively toured across the globe during the past couple of decades, participated in exhibitions and seminars, and interacted with different supplier and vendor communities. He has learnt various changing needs of customers and spearheads his team to live up to the customerâ&#x20AC;&#x2122;s expectations. Always working closely with our customers and supporting them with our knowledge and experience is the key of success at Ecobliss, he proudly describes. Alliances with many international companies who have multi faceted experience always help Ecobliss to upgrade their technologies to meet the increasing needs of the customers. Apart from the key cold sealing Ecobliss Pharma systems, the company is looking forward to cater to other segments by providing high visibility blister packaging solutions to meet the market demands.

a crucial role in healthcare product development and

Ecobliss by now has extended its services to almost all the

marketing. Its packaging development team makes it

major pharmaceutical companies in India by providing

possible to have large variety of design options.

customised packaging solutions to them.

The product range varies from Carded blister packs,

Its operations being in Hyderabad, the Pharma capital of

wallet packs with various design options, dosage packs,

India, Ecobliss extends all its expertise to this segment to

clinical wallets, promotional packs, combination packs,

get benefits from its technology. This is very vital as the

standby packs etc.

expectations are that the demand for manufacturing

Apart from providing the design, development services and packaging material, Ecobliss also provides its customers a whole range of packaging machinery that suits the requirements of packing different volumes. This

generic drugs from India will be moving North and suitable genuine packages like the cold seal Ecobliss Pharma systems will be vital for the US and regulatory markets.

equipment ranges from table top manual sealing jiggle roller machines to fully automatic high-speed packaging systems.

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Pegasus Farmaco India

Think BIG… Become BIG “Think Big”- Always works wonders! Two magical words, made possible for the formation of Pegasus Farmaco India Pvt Ltd to become a reality. These are the motivating factors for the success story called “Pegasus Farmaco!” Pegasus Farmaco made a foray into the pharma industry way back in 1995 with a humble beginning. Today, Pegasus Farmaco has created a niche for itself in the pharma industry. Raghuveer Beti, Chairman and MD, Pegasus Farmaco

Since its inception, Pegasus has believed in the Best quality and Cost effective products as its USP and created a strong base for itself in the market. The company has always made the right strategic moves in the process of achieving its vision by knowing the pulse of the

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pharmaceutical industry, using vast marketing experience of the management; timely

APART FROM PRODUCING ITS OWN PRODUCTS, CURRENTLY PEGASUS FARMACO HAS GOT MANUFACTURING TIE UPS WITH ABOUT 30 COMPANIES, INCLUDING TOP COMPANIES OF INDIA EITHER ON P2P OR LOAN LICENSE BASIS FOR BRANDED, GENERIC AND EXPORT QUALITY PRODUCTS.

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introduction of a new molecule in to the market, flawless distribution methods, living up to the expectation of the people involved in the process, right from manufacturing process to the end customer. Today, under the dynamic leadership of Raghuveer Beti, Chairman and Managing Director of the company, Pegasus Farmaco has shown multifold growth in all aspects i.e. in acquiring Manufacturing Facilities, Professional Manpower, Good Distribution network and Business Partners. Apart from world class quality and cost effective therapy, the uniqueness of the company lies in its huge product range and product design for better patient compliance and faster cure. In addition to these factors, the expertise of the Sales personnel has made the company to become a successful ethical pharmaceutical marketing company. While South India is the company’s strong hold, the company is making its presence felt across all major states of North India to become a pan India operating pharmaceutical company. The company is currently growing at an average growth rate of 20% every year and is aiming at growing at

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30% for this FY. The company is all set to take off to

capsules, ointments, injectables with latest drug delivery

achieve its objectives by pursuing global standards in its

methods and most importantly a full-fledged R&D unit.

people, products, processes, performance and

With this set up, the company is aiming to make a foray

partnerships.

into the lucrative clinical trials business. This unit will start

The company is always a front runner to explore opportunities to make its vision a reality. With an ambition to position itself as a partner for global companies by providing quality and cost effective solutions in

commercial production by March-09. With both units fully operational, the company will be able to cater to its own production requirements and P 2 P/ Loan Licensing requirements in both South India and North India.

formulations manufacturing, it had come up with its first

As the companyâ&#x20AC;&#x2122;s future looks very bright, it is looking

unit at Roorkee, Uttarakhand, in the year 2005, which is a

forward to come up with the injectables, soft gel

state-of-the-art manufacturing unit, well equipped with

capsules, and drops very soon. The company is also

ultra modern machinery and lab equipment for

looking forward to come up with the Specialty Divisions in

manufacturing export quality products. The manufacturing

a phased manner for the convenient and wide market

facilities are designed to meet the stringent cGMP and

coverage for higher revenues.

cGLP specifications. And it is gearing up for the Global Quality Certifications such as ISO and initiated the process for global regulatory agencies such as MHRA, TGI etc, to enable itself to get into our own export business. The company is currently manufacturing 100 high demand formulations to cater to the requirements of all the segments which are marketed ethically by its professional Sales Personnel. Products are being accepted well by the medical fraternity across India. Few of the brands are one of the top sellers in some of the territories across India. This unit has got the huge capacity for catering to the needs on the basis of P to P/Loan License for other pharma companies. Apart from producing its own products, currently Pegasus Farmaco has got manufacturing tie ups with about 30 companies, including top companies of India either on P2P or Loan License basis for Branded, Generic and Export quality products. The list is growing still. It is also a testimony of the

At Pegasus Farmaco, human resources are always treated as assets of the company and are given due importance. They are the primary contributing factors for the success of the company. Hence, the company aims to recruit, retain and motivate people by offering competitive reward packages and by helping employees achieve their potential through training, development and a good work environment. The Company has a professional team that is completely focused on delivering to the best of its abilities in every task they perform. The Company strives to continually instil team spirit and recognise team achievements as well as individual expertise and excellence. It is evident that because of the professional, ethical and service oriented practices of the company, the company has not got affected due to the recession world wide. Pegasus Farmaco is one of the few companies that is constantly performing at steady growth rate.

relentless endeavour for achieving desired goals of the

Pegasus Farmaco is committed to excellence in all our

company.

endeavours. It is committed to the highest levels of

In view of its future requirements and expansion plans, the company is coming up with another State of the art unit at Bhongir, in Nalgonda District of A.P, which is near its headquarters at Hyderabad. It will accommodate other important segments such as liquids, soft gelatine

ethical practices for living up to the expectation levels of all of them, with whom the company is associated. As a growing company, Pegasus Farmaco is open to have any kind of business association with top Indian and Multinational Companies for a mutual benefit.

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Timetech Formulations

“Sustained Success” Timetech Formulations Ltd was among the first to develop innovative drug delivery pellets technology and various timed-release formulations. The timedrelease formulation technology has propelled Timetech to a place of prominence, in the competitive market. The company specialises in Sustained Release technology, which reduces cost of medication frequency of dose besides minimising side effects; Timetech has managed to become a trendsetter in G.N. Raju, Managing Director, Timetech

Novel Drug Delivery systems.

Hyderabad based Timetech Formulations Ltd., a forerunner in new drug delivery pellets technology and various timed release formulations, produces a wide range of products that include antibiotics, anti-allergens, anti-ulcerates and cardio-protective drugs.

“

G.N. Raju, Managing Director, said, “Timetech was formed in 1996, for the concept of the

THOUGH TIMETECH IS STILL INDEPENDENT IN ITS OPERATIONS, WE ARE ON THE LOOKOUT FOR PARTNERSHIPS FOR RESEARCH AND DEVELOPMENT. SINCE WE ARE EXPERTS IN THE LINE OF NDDS, WE PLAN NOT TO DEVIATE FROM THIS AREA OF EXPERTISE. INSTEAD WE STRIVE TO FURTHER EVOLVE WITH THE CONCEPT OF NDDS

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Novel Drug Delivery System. It has been a family owned business since the beginning”. The formulations of the Company are inclined towards making innovative drugs. The company has a well-equipped state-of-the-art manufacturing facility at Kukatpally on the outskirts of the city. Timetech, is all set to deliver fully integrated drug delivery system solutions, including formulation and development studies, product registration and manufacturing. There was a need and a demand for optimizing therapy with established drugs. The Novel Drug Delivery System (NDDS) with its efficacious solutions is providing the panacea for qualitative medication. Through better understanding of pharmacokinetics and low toxicity, NDDS has now come to be recognised as the answer for safe and effective delivery of drugs. Raju said, “The NDDS renders the patients increased efficacy, simplicity, safety compliance and comfort. For the healthcare providers, the system improves the cost effectiveness of drugs and treatment. When compared with multi-dosing preparations, the cost effectiveness would be 20 to 30 per cent”.

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The NDDS is highly beneficial for patients: it helps in

development. Since we are experts in the line of NDDS,

reduction of adverse effects; it is also capable of

we plan not to deviate from this area of expertise. Instead

preventing high, localized concentration of a drug, thus

we strive to further evolve with the concept of NDDS”.

minimizing gastric irritation; it enhances patient compliance in reducing the frequency of dosage.

The formulations they produce are sold directly to their customers. They undertake contract manufacturing from

By maintaining the blood levels in the therapeutic range

pharma companies and also make their own products

from longer duration, the NDDS does the effective

which are sold in the ethical market through hospitals and

management of the disease condition. By avoiding the

doctors’ prescriptions.

night time dosage, the NDDS helps the patients, which otherwise could cause disturbance to them.

The Company owes its grand success to its well experienced, qualified, and committed technocrats; good

Timetech is manufacturing and marketing various

teamwork with conscious and continuous effort to

pharmaceutical formulations like antibiotics, anti-

upgrade knowledge and technology; and quality

allergens, anti-ulcerates, cardio- protective drugs,

consciousness of individuals and stringent methods of

NSAIDS, nutritional and anti-bacterial.

quality checks, at different levels.

The company has diversified its formulation-making

Timetech believes Pharmaceuticals is an evergreen

activity to neuro, psychiatry and diabetic segments by

industry. They strive to maintain their level of quality and

developing molecules in SR formulations. The company’s

regulatory standards. Market monopoly seems to be their

timed-release pellets and formulations are exported to

ambition by way of producing unique pharmaceuticals.

U.S.S.R., South African countries and some parts of

And offering lower cost options to patients has always

Europe. It will continue its efforts to develop newer

been the dictum. So far, it has been smooth sailing for the

molecules under the NDDS, and it aims at being the best

Company, largely due to its strong hold in the market.

among equals.

Raju proudly said, “Timetech has reached a stage where

They have their own R&D setup for drug discovery and an

it is ready to take up any challenges in the Novel Drug

able marketing department for selling their products and

Delivery System”.

recently have also started exporting pharmaceuticals. Timetech has acquired an 80,000 sq. ft. area in the Bollaram region of Hyderabad. At this new facility, formulation development will be of highest priority. They plan on starting this new facility in 2009, which will comply with the latest regulatory norms. Their expected turnover is slated to increase from Rs. 3 crores to Rs. 10 crores. Efforts are on to combine all the different facilities under the Timetech banner.

THE COMPANY HAS DIVERSIFIED ITS FORMULATION-MAKING ACTIVITY TO NEURO, PSYCHIATRY AND DIABETIC SEGMENTS BY DEVELOPING MOLECULES IN SR FORMULATIONS.

What does the future hold for Timetech? Raju explained, “Though Timetech is still independent in its operations, we are on the lookout for partnerships for research and

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Glaxcare Formulations

The Formula for High Quality Health Care Having made big strides into the formulation segment and having a strong hold in the manufacturing of monopoly products, Glaxcare Formulations Pvt Ltd has come a very long way since its inception back in the year 2005. Over 15 years of professional experience was incorporated to form this Company, which now provides the assurance of a broad spectrum of quality products, tested at various production levels in complete compliance with GMP (Good Manufacturing Practice) standards. Srinivas Mukka, MD, Glaxcare

Glaxcare’s products range from Antibiotics, Anti-Ulcerants, Multivitamins, and Haematinics & Calcium preparations to Anti-Allergic products, Digestive and Proteolytic Enzymes, AntiFungal and Anti-Spasmodic formulations. These formulations are manufactured at the Company’s production plant in Bhongir, on the outskirts of Hyderabad. This manufacturing

“

plant complies with WHO GMP norms required for Plant and Machinery, and is spread across

THE COMPANY SHALL LAUNCH A RANGE OF AYURVEDIC, DERMATOLOGY AND DENTAL PRODUCTS; THEY HAVE RECENTLY LAUNCHED THE PARENTERALS SEGMENT ALSO. THE COMPANY’S GROWTH AND SUCCESS ARE VERY EVIDENT FROM THE FACT THAT THEY HAVE MANAGED TO INCREASE THEIR SALES BY 30% THIS YEAR.

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an area of 15000 sq.ft. The Company is also looking into adding to their line of products; plans are of foraying into specialty formulations for Diabetes, Cardiovascular and other monopoly areas, at an 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, Glaxcare. 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. The Company’s growth and success are very evident from the fact that they have managed to increase their sales by 30% this year. The number of formulations has also gone up from 85 to an impressive 115. Commenting on the growth of the Company, Mr. Srinivas stated, ”We have also entered in to new speciality productions with a diabetic range along with neurological and cardiac areas. This coming year, we plan to start ethical marketing division for speciality products,” said Srinivas.

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Pulse Pharmaceuticals

“Excellence through Applied Innovation”

“Winners do not do different things, they do things differently” - Sive Khera. This is what exactly ‘Pulse’ calls “applied innovation”. It always believes in doing things differently. The company applies innovation in every sphere of its activity, be it, product development and manufacturing, product promotional strategies, process monitoring systems, CRM, Employee Relation Management, or Stockist Relation Management. In fact, this orientation is what keeps the company, going ahead. Pulse Pharmaceuticals Pvt. Ltd. ventured into it’s business in the year 1997, when the market conditions were not so favorable for start up companies. The chief promoter of the

“

company K V Rambabu, who comes from a middle class background had nothing much to

BESIDES CONSOLIDATING IT’S DOMESTIC SALES, PULSE IS ACTIVELY EXPLORING THE PROSPECTS OF OVERSEAS BUSINESS. IN ADDITION, THE COMPANY IS ALSO PLANNING TO MANUFACTURE PRODUCTS OF SOME SELECT PHARMA CLIENTS ON PRINCIPLE TO PRINCIPLE BASIS.

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invest into the business except a strong desire and passion to start a pharmaceutical company and make it big for the world to feel its presence. Pulse works on triple “P” principle: People, Products and Processes. It has been constantly innovating and upgrading its competencies in all these three areas. Pulse has established its operational presence across India with a field force of over 400 people and the company enjoys very good reputation among topnotch consultants of the country. Pulse has recently set up a state of the art manufacturing facility in the northern region of the country (Roorkee, Uttarakhand), complying with the cGMP norms. This facility has been WHO GMP certified. The company has also set up a fully equipped R&D facility with in the same complex for new formulation/Process development. Pulse has competent professional teams operating in R&D, Production, QA & QC. Pulse believes that it has all the essential ingredients and formulae to play a prominent role in global pharmaceutical industry.

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Stanex

Feeding Animal and Human Needs Alike Stanex is a leading organization in the Animal Nutrition Sector in India. India’s largest producer of poultry, premixes, veterinary and poultry drugs; a provider of leading product and technologies; a repository and delivery mechanism for science and knowledge in animal nutrition; a testing centre of outstanding capability for both laboratory and animal studies, Stanex is a dynamic progressive organization. K. Bhagavan Reddy, MD, Stanex

Stanex needs are satiated only through efficiency improvement achieved by its clients. They developed first-class expertise in the production of liquid solutions, suspensions, tablets and poultry feed supplements. Product innovation, quality assurance flexibility and cost effectiveness are fundamental cornerstones of the Company’s national success and growth.

“

Stanex was established using the experience from last 15 years in marketing and

THE TOTAL TURNOVER ATTAINED BY STANEX IS ABOUT RS.15 CRORE PER ANNUM, WHILE THE EXPECTED TURNOVER IN THE NEXT 3 YEARS IS CLOSE TO RS.100 CRORE OWING TO OUR NEW INJECTABLES AND HERBALS SEGMENTS

production. “The parent company of Stanex was started off in 1993 and dealt mainly with poultry and veterinarian drugs such as liquid orals, tablets and dry powders. The company was a lead player in the ethical market of Andhra Pradesh, Tamil Nadu and Karnataka”, explained Bhagavan Reddy, Managing Director. In 1995, they diversified into the animal feed segment and started a feed producing plant. It was christened Sumax Foods and Feeds Pvt Ltd, and catered to the integrated market of poultry and livestock feed supply. A few years later, in 2001, they started hatcheries for day old broiler chicks; and finally Stanex was flagged off in the year 2004 as an independent firm dealing with drugs and chemicals for veterinarian and animal diet use. They established a new production unit as per CGMP model, for Sterile Injectables in 2006, which would cater

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to human and veterinarian purposes. Stanex is planning on international business operations with reputed and respected expertise in animal nutrition and health. Their latest innovative efforts came in 2007 when they forayed into the business of herbal extractions. This

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