Now clinical research opts for outsourcing

After business, knowledge and legal process outsourcing, the Indian industries are now eyeing 'diagnostics jobs' outsourcing from other countries.

According to industry experts, a number of hospitals in the US and Europe are outsourcing laboratory and diagnostic tests to India as it helps in saving cost and money while maintaining quality.

The Indian diagnostics and pathology laboratory business is around $864 million and is growing at a rate of 20 per cent annually, they say.

Accordng to the Federation of Indian Chambers of Commerce and Industry, the size of the global clinical trials market was nearly $10 billion and predicted to have touched by $26 billion by 2007.

"Diagnostics and lab testing outsourcing is certainly the most potential business domain. We are trying to tap available opportunities in it," says Dr G S K Velu, Managing Director, Metropolis Health Services India Ltd.

"There is an excellent outsourcing opportunity to test around one million samples a year," he says.

The other emerging sector --Clinical Research Outsourcing -- is also witnessing surge in the country. The drug manufacturing units are outsourcing different phases relating to development of medicine to India.

In the case of diagnostics, X-rays and other procedures are done abroad and the reports by experts are written here and sent back, while in the case of lab tests, the photomicrographs are electronically sent here and the doctors send back the results.

We plan to offer tele-pathology services to cater to the needs of foreign clients faster, he says adding that countries like West Asia, Srilanka, Africa, Nepal, Bangladesh and UK outsource tests to India.

At present, the volume is not very high but the market potential is huge as European countries as also the US are in talks to outsource their work in this area.

Metropolis, that provides hospital Laboratory management services and outsource number of diagnostic related works to India, has number of labs in Middle East and South-East Asian countries, including Thailand, Indonesia and Vietnam.

"We processes more than 10 million sample tests per year and around one per cent from outsourcing, Velu adds.

There is a great opportunity for tapping CRO in the nation. The volume of business is expected to touch $1-1.5 bn mark by 2010.

There are as many as 30 Global CROs and 100 companies involved in doing clinical research related jobs in the country.

Most of the work comes from US (almost 20 per cent) and Europe (70-80 per cent). We undertake approximately 300 studies a year

It is not the lack of expertise behind outsourcing Clinical Research related jobs. But, availability of manpower and time saving

The sector is also poised to deliver excellent job opportunity and career options to research fellows. McKinsey estimated that the Indian CR (clinical research) market will grow to $1.5 billion in value by 2010.


Asserting that the country has bouquet of products to offer to foreign clients and attract outsourcing, he said. "There is urgent need to market our products globally. The government has to start speaking globally about diagnostics and lab work outsourcing in the same way as information technology."

Pfizer continues on rare disease path with new R&D unit

Pfizer continues its foray into rare diseases as it creates a new R&D unit to investigate novel therapeutics for conditions such as Haemophilia. The pharma giant joins GlaxoSmithKline and Novartis as companies looking into producing specialised drugs as a way to offset slowing sales growth and loss of blockbuster patent protection.

The new unit created within Pfizer’s Worldwide Research and Development operation aims to capitalise on Pfizer’s existing research into such conditions as Haemophilia. In the past, Pfizer have also expressed its interest in treatments for muscular dystrophy and other conditions caused by genetic mutations.

The creation of an R&D unit represents a significant strategy shift into rare diseases for the firm. In December of last year, Pfizer agreed to pay $60 million initially with a further $55 million to license the worldwide rights to Protalix Biotherapeutic's drug for Gaucher disease.

This shift also produced job cuts as the company announced last month its intention to shed roughly 6,000 manufacturing jobs worldwide over the next five years.

This includes approximately 300 at the Andover biotechnology plant Pfizer took over when it bought Wyeth Pharmaceuticals for $68 billion last year.

With the impending expiration of blockbusters and a slowdown in emerging pipeline candidates, industry insiders believe pharma’s passing interest in specialised markets is gaining increasing momentum.Drugs produced for ultra-orphan diseases with high unmet needs have an easier time commanding high prices. Genzyme’s Cerezyme, another drug used to treat Gaucher disease can command prices of up to $200,000 a year while medicines for cancer can cost $50,000 or more a year.

In addition, the growing trend of pharma companies using biomarkers to improve on current methods to define populations of patients increases the prospect of smaller markets suddenly becomes more attractive and financially viable.

Pfizer joins a growing band of companies who are currently pursuing treatments for rare diseases. In March, GlaxoSmithKline (GSK) steeped up its efforts to build a rare diseases business which saw the UK pharmaceutical major launch its own dedicated R&D unit.

Bristol-Myers Squibb has signed agreements with clinical development service providers, Icon and Parexel, for joint strategic, operational and capability support of its clinical development program.
As per the agreement terms, Icon and Parexel are expected to provide support for Bristol-Myers Squibb’s clinical studies to support its full development pipeline over the next three years.
Bristol-Myers Squibb is preparing for a large volume of clinical development work that is expected to require expanding upon its existing partnering approach for clinical development.
Bristol-Myers Squibb also stated that, consistent with the its BioPharma strategy, the agreements with Icon and Parexel are expected to complement its internal capabilities and capacity.
Brian Daniels, senior vice president of global development at Bristol-Myers Squibb, said: “These partnerships are expected to increase the operational capability of our clinical development organisation, and support our position in productivity and innovation.
“Working with Icon and Parexel, Bristol-Myers Squibb will enhance support for our pipeline and improve our ability to deliver medicines to patients with serious disease.”
John Hubbard, president of clinical research services at Icon Group, said: ‘‘We are delighted that Bristol-Myers Squibb has selected us to support its clinical development programs.
“Over the last ten years, we have forged a partnership by working hard to fully understand Bristol-Myers Squibb’s requirements. We look forward to moving this partnership to another level and continuing to support Bristol-Myers Squibb’s goal of bringing treatments to patients."
Josef von Rickenbach, chairman and CEO of Parexel, said: “We look forward to a deeply collaborative relationship with Bristol-Myers Squibb to help provide solutions for its growing pipeline, as well as leverage our capabilities and technology infrastructure to support the effectiveness of its clinical development programs."

US CRO Kendle sets up in Ahmedabad

US CRO Kendle has opened a new services centre in India, attracted by the country’s thriving contract research sector and favourable climate for clinical trials.
The 14,000 sqft centre, in the Ahmedabad-Gandhinagar special economic zone (SEZ), will provide clinical data management, pharmacovigilance and biostatistics services to sponsors running trials in the region.

Kendle has had a presence in India since 2004 with its unit in New Delhi and has been expanding to allow its clients increased access to the nation’s favourable research conditions.

COO Stephen Cutler said that: "Growth in India is a key component of our strategy and will be very important to the future" adding that an "expanded presence in Asia, and in India in particular, creates efficiencies in the clinical development process.”

In an interview in the Business Standard Cutler contrasted India with Asia’s other contract research hotbed China, explaining that “India's edge… lies in its favourable regulatory environment and research initiatives as well as investor-friendly duty structure.”

The new unit will begin operations with a staff of fifty although Kendle plans to scale up this up in the next few years, benefiting from the units “proximity to multiple universities” in and around Ahmedabad.
Aside from access to large population centres and proximity to a number of pharmaceutical manufacturers the Ahmedabad-Gandhinagar also provides Kendle with others benefits due to its status as an SEZ.

Operating in an SEZ gives contract research organisations (CROs) like Kendle, and GVK Biosciences who set up there in March , staged tax benefits, including a five year 100 per cent exemption on export income.

New norms for clinical research organizations soon in India.

The government will soon make it mandatory for all firms involved in clinical research to maintain minimum quality standards and register themselves with the country’s drug regulator.

Once the law is implemented, the names of all the approved Clinical Research Organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.

Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs. The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.

Industry experts believe that this will regulate the entire clinical protocols, ethical norms and other practices. At present, there are 40-50 CROs in the country, a number that is increasing steadily. All these provide research services to drug companies in developing medicines, especially the clinical trials.

Admissions for the Next Batch

Admissions for the next batch of clinical research (2010-11) are now open. The application form can be downloaded from our website

Clinical Research: Issues and Opportunities

Clinical research is an indispensable part of the drug discovery process to ensure the safety and efficacy of any new drug. In today’s global scientific era, clinical trials are the mainstay for bringing newer and better drugs to market. Although a set of robust guidelines is available to govern the conduct of clinical trials in any country, the conduct of clinical research is also looked upon as an area of humanitarian concern. Various articles published recently in the professional and popular press enumerate the opportunities and challenges of conducting global clinical trials
in India.However, the majority have been from the perspective of authors who have never conducted clinical trials in India themselves.
A nation with more than 1 billion people, India has the second largest population in the world.Having gained its independence from British rule in 1947, its prime minister is the head of government and its president is the head of state. Internationally, India became a member of the World Trade Organization (WTO) in 1995 and agreed to adhere to the product patent regime by 2005. As a result, the global pharmaceutical industry has the rights to patent products as well as processes throughout the world, including India. This has led to a significant
growth of the pharmaceutical industry, both domestically in India and globally, including increased stakes of multinational companies in Indian operations. As a signatory to the WTO agreements, India is looked upon as a favorable destination for conducting global clinical trials. India clearly provides an opportunity in terms of availability of large patient populations, highly educated talent, a wide spectrum of disease, lower costs of operations, and a favorable economic and intellectual property environment. The overall time and cost advantage in bringing a drug to market by leveraging India’s resources could be as high as US $200 million, hence the steadily
increasing number of global studies in India over the past two years. Major pharmaceutical companies estimate the total market for conducting clinical trials either directly or through contract research organizations (CROs) in India through 2010 at US $2 billion. CROs themselves are fast gaining importance because of their global presence, specialized local expertise, and competitive pricing strategies. And a significant number of new CROs have set up operations
in India over the past two years. However, some key barriers stand in the way of opportunities, including patients’ rights and safety, regulatory framework, infrastructure, organization of ethics committees, data quality, lack of training curricula focusing on clinical research, and other factors.Most of these barriers are common to all developing countries and need to be addressed in a similar way.
Because the clinical investigator plays a major role in the ethical conduct of any clinical trial, its successful outcome depends on how the investigator(s) has assumed overall responsibility. Most of the barriers mentioned above can be easily addressed if a clinical investigator is
committed to the ethical conduct of trials.
A segment of ideologues in India believe that clinical trials conduct poses a serious threat to society because of issues related to patient rights and safety, regulatory compliance, unethical trials, infrastructure and training issues, and exorbitant drug pricing. These threats are perceptions, not reality.
A well-designed and executed study has built-in provisions to ensure patient rights and safety.In fact, a patient may be far safer in a clinical trial than in routine medical care because careful
observations are made on safety (toxicity) and efficacy.
Although it typically takes 10 to 12 years and millions of dollars to bring one new drug to market, the success rate is small
In the developing world, no company or institute wants to, or can, invest such time and resources for a marginal improvement in responses over existing therapies. Fortunately, in a majority of cases, clinical trials can provide answers regarding the use or not of a therapeutic
agent that can benefit millions of patients worldwide. Being the second most populated country in the world, India can contribute significantly to global drug development programs.
The foundation of knowledge-based industries in India was laid down by the information technology industry, and there is no reason why clinical research cannot follow in those footsteps. Indian investigators and clinical research professionals have already demonstrated their
medical and scientific skills by participating in multiple global clinical trials. It
is time now to move forward to capitalize on the opportunity.