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I happen to be in South Africa on holiday during the annual budget speech, on Feb 21, 2007, by the Minister of Finance Trevor Manuel. This is his 11th. During this occ

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

asion he announced the first budget surplus for the country since 1960. Regrettably, the media did not shower him with the applause he deserves for this. In fact the h

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

Examples of combination products may in

eadlines of the Cape Town newspaper, which I got to read about the budget, screamed “Manuel’s spending spree”. Yes, he is spending, but that’s because he has the money

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

to do so.

Developing countries tend to run even larger deficits than developed countries and subsequently need to borrow money to fund basic infrastructure and socia

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

l services. The success of this particular Minister of Finance rests on several factors. The most important one is that the Inland Revenue services, or the South Afric

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

Combination pro

an Revenue Service (SARS), has been hugely successful in collecting taxes. In fact SARS collected R29.5 billion more during the year than had been expected.

Secondly,

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

Manuel has been frugal in his spending during the years that he has been at the helm of the ministry. Many times he has been strongly criticised for not spending more

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

on alleviating poverty and increasing job opportunities for the huge unemployed work force. These two in particular, poverty and unemployment, are considered the main

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

contributors to the high crime rate in the country. Through this fiscal conservatism, he has been able to reduce the personal and company tax burden over the past year

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

s. One of the benefits of this has been an annual steady growth of the economy.

With the success of the collection of revenue he is able to fund large increases in sp

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

ending towards teachers’ salaries, health workers and crime prevention services as well as road and transport infrastructure for the World Cup in 2010. Of course, as u

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

Following aspects would a

sual, he has been criticised for not spending enough on immediate poverty relief. Spending the money on education and training, for me, is a better strategy. But then

dd to the challenges in developing combination products:

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

I am not living in a squatter camp with no food for my children, I am not qualified to comment. Increasing the police force and extending the justice system, is extrem

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

ely important if one wants to make any difference in the high crime incidences. With other words, excellent job Trevor Manuel. Even the opposition has been muted in th

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

t the normal vocal outburst of heavy criticism that generally accompanies the budget speech, has been particularly subdued if one can believe the newspapers.

Often So

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

uth Africa, and I have added my voice to this, is criticised heavily for not delivering in all sorts of areas, not the least for not interfering in Zimbabwe’s economic

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

Professional from academic institutions, pharmaceutical industries, health care indust

and political implosion. Too often, recognition is not given for its achievements such as steady economic growth, tightly controlled inflation and sophisticated finan

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

cial services amongst many. For all its growing pains as a new democracy and with its mandate of trying to right the wrongs of the apartheid years, this South African

.

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

government is achieving some noteworthy successes. As for Zimbabwe, interfering might not have changed the course that the country has taken. Have a look at Iraq and w

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

Companies that provide selfless information through particip

hat interference has done to that country, and possibly leaving Zimbabwe to sort out its own problems may be the best solution after all. And yes, it is the same thing

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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