Advice You - Business

Franchise according to the dictionary means “Granting authorization to someone to sell or distribute a company's goods or servic

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

es in a certain area or certain places”.

Franchise is a license granted by a company or firm on certain terms and conditions to

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

Examples of combination products may in

an individual or firm to operate a retail outlet in a specified area or place. The company or firm which grants the license is

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

called as franchisor, where as, the individual who accepts the terms and conditions to operate a retail outlet is called as fran

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

chisee. Here the franchisee agrees to use the franchisors brand name, products, services, promotions, selling methods, add displ

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

Combination pro

ay and distributions on certain terms and conditions. The franchisee pays a fee to the franchisor for the license to sell its pr

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

oducts, services or goods.

This type agreement helps both parties, the franchisor gets new area to establish business where as

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

the franchisee will get already developed brand products and having no guess work about what to do, because all development and

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

decisions are made by franchisor and everything is laid out, step by step, with nothing missing or left to chance and it all wor

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

ks with precision.

The Legal Aspects of Franchising

In legal terms franchise is a contract. The franchisee is usually granted

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

an exclusive territory in which he or she is the only distributor of the particular products or services in a specified place. T

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

Following aspects would a

he franchisor is obligated to assist the franchisee through advertising, promotion, research and development, quantity purchasin

dd to the challenges in developing combination products:

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

g, training and education etc.

In 1979 the United States legislature had enacted the laws to protect prospective franchisees fr

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

om being deceived by the falsehoods of franchisors. The franchisor has to disclose all financial details such as profit, operati

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

ng cost, recurring expenses and five year actual sales statement and these laws are known as financial discloser law.

A franchi

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

sor also has to disclose the background of the company including the business experience of its high level executives and whet

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

Professional from academic institutions, pharmaceutical industries, health care indust

her any of its executives, within the last seven years, have been convicted of a felony or involved in litigation franchise busi

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

ness fraud, or have been involved in any proceedings for bankruptcy. In addition to this disclosure factual description of the f

.

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

ranchise and statement of the total funds to be paid such as initial franchise fees, deposits, down payments, prepaid rent, and

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

Companies that provide selfless information through particip

inventory purchases is mandatory. Conditions must also be clear on recurring costs such as royalties, rent, advertising fees etc

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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