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In 2000, over 150 million adults had diabetes worldwide. Experts predicted 200 million cases of diabetes by 2010 and as many as 300 million diabetics worldwide only

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ten years later. Much of the world’s attention is focused on those threatened with malnutrition or outright starvation and rightfully so but instances of diabetes

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

are rapidly increasing in every country and on every continent in the world.

By 2010, over half of the world’s diabetic population will be Asian due to the explosio

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

n of type 2 diabetes and China and India. Asians are hardly alone. Diabetes is expected to increase by over 40% in Latin America, by 50% in Africa, by nearly 25% i

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

Europe, and by over 30% in Australia. As you can see, no one is immune from the onslaught of diabetes.

The worldwide explosion in diabetes is being caused by a ph

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

enomenon called “globesity” by the medical community. Globesity as the term suggests refers to the number of people across the world that are obese. The Internatio

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

nal Obesity Task Force estimates that 300 million people are obese and another 750 million are overweight.

Over 30 million people die each year from obesity related

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

causes such as heart disease, stroke, and certain types of cancer in addition to diabetes. That amounts to a staggering 60% of disease-related deaths worldwide. Ob

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

esity has doubled in Japan since 1982, doubled in the UK and the U.S. in the past two decades, and increased by roughly 40% in most European countries in the last te

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

n years.

Contrary to popular believe, obesity is not a problem that only affects industrialized nations. In countries such as Egypt, Chile, Peru, Mexico, and Tonga

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

nearly a quarter of the children are overweight or obese. Even in Africa where nearly 1% of the children suffer from insufficient nutrition, 3% are either overweigh

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

t or obese. And the fact is that type 2 diabetes follows obesity so where obesity exists today a proportionate number of type 2 diabetes cases will exist to tomorro

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

w.

In the country’s health care system faces enormous challenges from the rising number of cases of diabetes. The influx of diabetics requires an army of trained d

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

octors, educators, nutritionists, psychologists, and emergency medical technicians. But that’s just the tip of the iceberg. The complications of diabetes are devas

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ating and require even more resources to treat heart disease, kidney failure, and retinopathy. And that requires additional hospitals, intensive care units, operati

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ng rooms, dialysis machines, and the list goes on.

But is that really the best alternative? A much better alternative would be to take actions to curb the epidemic

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

of obesity. Increasing the resources used to fight diabetes does the opposite as people will know that state-of-the art medical treatment is available and will be

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ess concerned about diabetes. How was the drunk driving epidemic addressed? Was the answer more police on patrol for drunk drivers? Actually that was partially th

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

e answer but education and stiff penalties changed the behavior of individuals over time and lowered the rate of drunk driving. Perhaps tactics similar to those tha

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

t got people to stop drinking so much could also be effective in preventing them from overeating which causes obesity and dramatically increases the risk of diabetes

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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