Advice You - Business

Franchising has gone international in various sectors. The world seems to be getting smaller as more and more companies

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

scan the globe to put up franchise operations. The international franchise market has expanded to a large extent durin

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

Examples of combination products may in

g the past few years. Countries throughout the world seem to be participating in the growth of industries that was prev

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

iously specific to a particular country only.

Some of the major industries are food, electronics, and automobiles, whi

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

h have shown a rapid growth through franchising worldwide. International franchising allows the companies to infiltrate

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

Combination pro

countries by introducing the product in the country in franchises.

Starting an international franchise can be very di

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

fficult and require extensive research in that market that might take years to finish. The company must ensure that raw

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

materials and other requisites can be found in the country itself as it is cost effective.

Certain legalities concern

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

ng the leasing of land or offices in a different country, receive the permission from the government to use trademarks,

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

tax related issues, and employing the regional manager or an area manager to manage the initial proceedings are few of

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

the initial hurdles to be crossed. A contract containing these aspects as well as other management criteria must be dr

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

Following aspects would a

awn up.

Since there definitely would be a difference in the currency, the fee amount, conversion rate, and such moneta

dd to the challenges in developing combination products:

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

y related issues must be considered. Some countries might have restrictions on the amount that can be remitted into the

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

country at a given time.

All the related government approvals must be considered at the initial stage itself. Some go

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

vernments need the company to get special licenses for putting up a franchise in the country. Also, all the monetary re

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

lated issues such as fee details, and repatriation etc need to be run through at the government office before being app

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

Professional from academic institutions, pharmaceutical industries, health care indust

oved.

The company must be ready with the financing and background check in order to confirm the time that would take t

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

o start the franchise. Accurate preparation will ensure the franchise will be up and running in no time with any additi

.

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

onal costs cropping up out of the blue.

There are various other aspects to consider before opening a franchise in a di

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

Companies that provide selfless information through particip

fferent country. It is suggested to go through the whole lot before signing an agreement for an international franchise

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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