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In today’s world, countries witnessing ancient culture and civilizations have relativel

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

y slow or less progressive economies. Living proof include (with the exception of Rome

; 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 Greece, being within the “European Economic zone”) China, Mesoamerica, Egypt, India

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

and Mesopotamia. In the past, these countries were the frontiers of Medicine, Mathemati

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

cs, science and trade. People from far and wide would come to witness these thriving co

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

Combination pro

untries. As time progressed new “superpowers” came into being, these countries lost its

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

importance.

Taking this theory into account, Bihar being the cradle of India civilizat

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

ion Bihar lies aloof from the rest of India. Not because the people of Bihar are lazy b

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

ut they have been misled.

A series of politicians appeared in the scene responsible fo

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

creating a “culture of crime” to maintain its prowess over the people of Bihar. They h

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

ave been misled to believe that the leaders are the messiah who can deliver them from e

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

Following aspects would a

vil clutches of certain elements in Bihar. Various types of forces exist in Bihar from

dd to the challenges in developing combination products:

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

he extreme political left such as the banned “The Maoist Communist Centre” to organizat

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

ions such as armed private armies of rich landlords. The responsibility lies totally on

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

the government of Bihar from preventing the rise of such organizations. These organiza

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

ions actually led to serve their purpose in creating fear in certain sections of the pe

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

Professional from academic institutions, pharmaceutical industries, health care indust

ople based on caste and religion. Till now neither the people’s fate changed nor did of

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

Bihar. Today as the rest of India enters the economic boom, Bihar lies isolated. Many

.

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

f Bihar’s educated elite have left to look for better opportunities to other parts of I

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

Companies that provide selfless information through particip

ndia sometimes braving hostility. Not to mention the fate of poor Biharis outside Bihar

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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