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Politics- a word detested by most of the common people. To an ordinary person, politics is a synonym to corruption,

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

misuse of power, money laundering and other malpractices. Politics has earned such a bad name for itself everywhere,

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

Examples of combination products may in

that even the most honest political leader is looked upon with suspicion. Elections come and go. Majority of the po

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

pulace does not bother to vote. They know, once elected a candidate forgets his electorate and runs after money and

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

power. But these elected leaders can play havoc or bring peace and prosperity in the society. It depends on both the

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

Combination pro

ir decisions and participation of people. It is true that political decisions and activities affect all aspects of p

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

eople's lives. But is it really unfortunate?

Right from start of elections, candidates go on talking glibly about t

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

heir plans to work for the benefit of all. They give speeches, hold rallies, fund raisers and waste precious money a

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

nd time- just for power. It's after they are elected, their ambiguous talk is exposed. Elected representatives often

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

get portfolios for which they are totally unqualified. Imagine an illiterate politician becoming a minister for edu

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

cation. Hard to believe but is commonplace in many backward countries. Such a man will be totally incompetent for of

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

Following aspects would a

fice and may end up spoiling the education system. The common man won't be able to do a thing except watching promis

dd to the challenges in developing combination products:

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

ing careers and dreams fade away into oblivion.

It's nothing new that money gets decisions reversed. Bribe more tha

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

n your adversaries and the decision or policy will be in your favour. Cigarette and liquor companies with backing of

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

billions of dollars put public health on the path of deterioration. The governments do nothing. This was brought to

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

light after so many years when a big tobacco companies were ordered by the American courts to dole out billions of

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

Professional from academic institutions, pharmaceutical industries, health care indust

dollars to people suffering from diseases acquired by smoking. Construction companies cut off trees in hundreds and

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

thousands to build new towers and buildings. All with no objections from the government. The environment suffers.

I

.

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

n most cases common people get most affected while not even being fully aware of the reasons. Thats the whole irony

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

Companies that provide selfless information through particip

of it. Most decisions and policies get formed without the peoples say. They are helpless watchers of the whole game.

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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