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I have never been able to understand the concept of Sanctions. The last few instances of sanctions on countries have been on Zimbabwe where people are starving to death, North Korea where people are starving to death and now possibly Sudan

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

where people are starving to death already. These are ones that I have observed, there are bound to be others. Can anybody explain to me how this works? Let's penalise a country and its citizens when they are already suffering huge economic

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

Examples of combination products may in

hardships.

Is it another instance of the general ignorance that the developed world has towards other nations that are not members of their little elite group of economic powerhouses? The thinking is, if we had sanctions against us we woul

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

d really suffer, so lets do this to these little countries. We are sure to get some kind of sensible reaction from the countries' leaders. Please! Neither President Bashir, nor Robert Mugabe will even blink at the news, or stop maltreating

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

heir citizens for one second or even nanosecond. These leaders have absolutely no regard for their people. They don't care whether their people suffer food shortages, death from uncontrolled militia attacks, disease from shortages of clean

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

Combination pro

ater and total disregard to human dignity and life. It is not on their register of concerns.

Possible the western countries further do not realise that these leaders do not have to be concerned about elections as they rigged theirs in the

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

first instance. They are not accountable to an electorate. They are not accountable to anybody. They pay off a support system with other words possibly the military or other political people. Mugabe just distributed a few, actually a couple

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

of thousand, white owned farms to his cronies to keep his support base happy. I am sure that Bashir has given away land, wealth or power to the nasties that are hounding, killing and terrorising the citizens of Sudan, and Chad now.

Interna

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

tional sanctions will not bring about the required changes. There is always some other country that will consider Zimbabwe's mines, for instance, as an important resource, such as China and will throw money at Mugabe. I lived in South Afri

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

a during many years of international sanctions. There were no shortages. There was always some country prepared to ship goods to South Africa or buy goods from the country and yes it had to be via via and no country of origin on the stamps

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

etc. Black market trade on a grand scale. A country can survive for years. And the whites didn't even feel it. The black South Africans, which the whole sanctions effort was supposed to support, were the ones who suffered. Sanctions in effe

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

Following aspects would a

ct stopped the economy from growing at any decent rate which meant no jobs.

Sanctions have a habit of punishing the very people they are supposed to help. What would really help? Nothing much actually. Military interference is not a good i

dd to the challenges in developing combination products:

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

ea. Numerous examples should warn against this, Iraq being a primary one. Unless the people have the will and strength to fight for their own rights, no external force can do it for them. One could possibly try and punish the leaders by a

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

ttaching their foreign investments, and believe me they have much money stashed away in foreign accounts. They don't trust their own economy themselves. Hurting the pocket can help. Regrettably, there will be somebody or some country elsewh

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

re who will offer to look after Mugabe's assets.

What else not to do. Do not interfere by giving money and support to some underground individual who says he can make a difference. This is a typical American strategy which has backfired in

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

many instances. American support of Saddam Hussein a few years ago being a fairly good example of how not to do it.

So what to do? The western countries need to provide more resources for the refugees. Give the armies something good to do

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

Professional from academic institutions, pharmaceutical industries, health care indust

for a change. The armed forces have the best equipment to move needed goods and services. Many aid agencies are hampered with transport issues. Bring in the Air Forces. They have planes that land on a handkerchief.

The best and most effect

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

ve relief efforts I ever saw was the support South Africa provided Mozambique a few years ago, during one of that country's worst floods. The army moved in providing food, water and shelter to refugees. Army helicopters rescued people where

.

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

they had escaped to, in trees, on top of houses on 'islands' in the floods. And the aid was immediate and where it was needed the most.

But for us individuals who have no clout to move our governments into doing the sensible, honourable t

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

Companies that provide selfless information through particip

ing by sending in aid, what can we do. Dafur is developing into another Rwanda. Lets not close our eyes to this tragedy. And if the only thing we can do personally is to donate to Oxfam or any other relief agency near you, then lets do that

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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