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The other day I was reading an article on Mahatma Gandhi, the famous Indian freedom fighter, who got India its independence from the British rule almost 60 years back. It is very inspiring to know about

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

his perseverance as a freedom fighter and how he remained determined to succeed in his crusade against the British in India.

Anybody today would show disbelief at the whole idea of non-violence that

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

Examples of combination products may in

this great soul practiced and persevered to the extent of being tortured to get India its freedom! Believe me friends, no other example can truly and fully symbolize the power of perseverance.

As an e

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

nthusiastic entrepreneur in home business, you all are committed to make your businesses prosperous, but don’t ignore the fact that being committed alone is not enough. One has to persevere along the wa

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

y too. After establishing your goals, work like a gimlet to reach your destinations.

Don’t worry about the results. If you give yourself to the cause, you are bound to get positive results, sooner or

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

Combination pro

later. Remember, it’s not so important how fast you move, what is more important is how you move. Speed is not perseverance. Paying attention to the minutest details in your routine work and making s

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

incere attempts to improve upon your mistakes is what I call perseverance.

You may get tired of working towards your goals on a daily basis, but here’s a piece of advice – no great job was done without

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

fatiguing the muscles and taxing the grey cells. If at all you do feel that way, you can assume success is around the corner!

Of late, a well known film maker in India has made two Hindi movies on t

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

he values of this magnanimous soul called Gandhi. Both the movies have been hugely successful which only goes to prove the relevance of his teachings even in the present times. His core preaching was pe

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

rseverance through non-violence that he practiced and maintained despite getting ruthlessly oppressed by the British.

That was the spirit, sticking to the cause against all odds. And the odds were lo

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

sing consciousness or even life! Hey! I am not comparing the freedom struggle with our good old network marketing business. Relax…! The point I am making here is the intensity of efforts required to a

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

Following aspects would a

chieve your goals. Success is like a greased pole, not so easy to climb!

March on to see what you have nurtured. Do not balk at the obstacles, jump over them and face them unshaken. Often, entrepreneur

dd to the challenges in developing combination products:

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

s become too much concerned about the quality of results. That’s wrong. Your effort should be to put in enough quality work to even foggily see your goal.

That’s where I come back to the Gandhian value

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

of perseverance, which is like the smoke bellowing out of a factory chimney that speaks volumes of the labor put in by hundreds of men to produce that quality product! Toil like the sun in the sky th

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

at unconditionally vows to spread its bright light on this earth, come whatever may. Imagine the efforts of so many toiling men in history, who never ever twitched against the adverse circumstances bu

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

t kept their spirits high setting extraordinary examples for others to emulate. Yours is still a simpler task!

Gandhi’s perseverance failed the British beyond their imagination. Albert Einstein has sai

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

Professional from academic institutions, pharmaceutical industries, health care indust

d, ‘Generations to come will scarce believe that such a one as this ever in flesh and blood walked upon this earth.’ That is the magic of his trait.

Make your efforts so intense that you set an example

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

for others to follow and benefit from. It’s easy to dive into something and start hoping for instant success, but soon you would realize, so much is required from you not in any monetary form, not mu

.

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

ch in physical form, but so much in the form of that emotion. Gandhi so rightly said, ‘We must become the change we want to see.’ If you aspire to see a change in your life, embody that change in you

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

Companies that provide selfless information through particip

first. Move out of that comfort zone and bring that change in your attitude and in your habits to finally see what you

have been dreaming of! Dedicating this letter to the values of an immortal soul!

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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