Main Subject - Business

Is the earth warming up? Are the polar ice-caps melting? If so, at what rate? These and a multitude of other global warming questions are mounting up across the world. Are there any answers to these questions? You bet! Take your pick. The

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

answers range from "global warming doesn't exist" to doom and gloom prophecies that it is already too late to save the planet.

The problems is that the environment has become a political and economic issue and the formidable forces of po

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

Examples of combination products may in

litics and economics have drowned out proper science. We can't even hope for a consensus of opinion because views are too polarised. Apart from political considerations, there appears to be a genuine failure to agree between scientists th

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

emselves. By scanning the wide vista of opinions out there, the only deduction I can make is that there is an approximate consensus that there is some warming of the earth taking place. That's about it. Many say that this is not to be tre

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

ated as unusual and is not man made. Others say that the whole phenomenon is man made and requires urgent action.

So what about those governments and those in government that simply want to do the right thing? Do they risk wreckin

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

Combination pro

g global economies by drastically cutting back on CO2 emissions and other pollutants? Or do they do nothing and risk catastrophe? And what of the rest of us? Are we to remain powerless while the world slugs it out? Can anybody or any orga

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

nisation give us some definitive statement of the true position and precisely what is to be done?

Businesses also need facts. They are not against taking whatever action is necessary to deal with the situation. After all, they need to pro

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

ect the interests of their owners as well as their staff and management. They will act if they are told exactly what is to be done. The trouble is that one business will not act in isolation if it means they will be disadvantaged in their

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

market. Because many markets are global, this requires global decision making. There are a few business who are actually demanding some kind of legislation - that is, some leadership - so that they can act multilaterally on a level play

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

ing field and get the job done, whatever it takes. I am sure these demands will grow louder as the uncertainty continues.

So, we are back to square one. No global decisions, no global consensus and no significant action.

There are some

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

shafts of light that can be seen through this obstruction. The above assumes that reduction in CO2 emissions and other pollutants will harm businesses. If it is done at too short notice and without proper consideration then that is proba

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

Following aspects would a

bly true in nearly all cases. Let us consider, though, that energy costs money and the use of energy is the major cause of CO2 emissions. Companies can do something about their CO2 emissions and gain a financial advantage. Why? Bec

dd to the challenges in developing combination products:

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

ause of simple mathematics. Cutting energy consumption reduces bills and - may help to save the planet.

Take building design as an example. Using solar panels fixed to the roof of a building can allow that building to supplement its ener

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

gy requirements.

Another example: distribution companies can invest in software and working practices to reduce empty running. Today there are many regions where vehicle utilisation falls below 50%. We know this can be improved. Why is it

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

that frozen food vehicles have a higher vehicle utilisation rate than dry goods vehicle when they both carry long life goods? Answer: because frozen goods transport is more expensive. Because of this higher cost, carriers have found ways

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

to consolidate loads to reduce empty running. So it can be done when the incentive is there. The point I am making is that the financial incentive is already there - there just happens to be a greater financial incentive for the fr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ozen food sector. The environmental incentive therefore goes hand-in-hand with the economical incentive.

With the advent of home shopping over the internet we have seen the growth of small vans that are driving up and down the nooks and

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

crannies of the country making deliveries of one or two parcels or a couple of bags of shopping. Isn't it time some of these operations were consolidated? For what it is worth, we are doing our bit. Arkay Hygiene dispatches goods using a

.

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

national UK courier or by using Royal Mail. By using such large carriers we know that routes are planned to carefully avoid excessive dedicated journeys.

When environmental requirements and economical requirements coincide - as they so o

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

Companies that provide selfless information through particip

ften do - I see no reason why unilateral action cannot be taken to reduce energy consumption - whatever the scientists and governments say about the wider picture. And the sooner we agree on the global way forward the better for all of us

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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