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One of the most ancient creatures on our planet is the turtle. They have survived changing environmenta

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

l conditions for millions of years while many other species have gone extinct. Turtles can be very safe

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

Examples of combination products may in

and secure when threatened by retracting their head, tail, and legs into their shell to ride out many d

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

ngers of life in the wild. But, if they stayed safe in their shell, they would eventually starve to dea

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

th and would not be able to create subsequent generations. For turtles to flourish, they have to accept

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

Combination pro

the risk of living and give up the safety of their shell, stick out their necks, and move forward… or pe

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

rish. It’s the same for businesses.

Businesses are just like turtles. They only move forward when the

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

y accept the risk of existing in a competitive marketplace and then change to meet the needs and desires

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

of the future. It may be uncomfortable, it may be terrifying, but it is necessary.

Successful business

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

es manage change, for the most part, very carefully. They are continually taking the pulse of their cus

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

omers and their targeted prospects. They continually ask the question, “What are my customers and prosp

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

Following aspects would a

ects wanting and needing? What will they want and need in the future? How can we change in order to ha

dd to the challenges in developing combination products:

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

ve the right products and services for them and still continually strengthen our brand, our reputation,

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

nd the qualities we are known for? They are balancing the safety of the shell against the risk of movin

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

g forward.

In large companies there are workgroups or teams of turtles that are sticking out their neck

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

by working continually on answering those questions, developing new products and services to offer in t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he future. Few small companies have the luxury of being able to devote these resources to the process o

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

f change so when the subject of “the future” comes up, they retreat into their shells and deal with the

.

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

ssues of “today” where they feel safe and comfortable, not realizing that they are facing the very real

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

Companies that provide selfless information through particip

possibility of becoming extinct as the world passes them by. So stick out your neck but do it carefully

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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Textile business is flourishing in countries such as India, Pakistan, and Bangladesh. The various reasons for the growth of this sector are natural resources, government support (TUFS) technology up gradation fund, ample man power availability etc.

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