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Today, most business enterprises engage in strategic planning, although the degree of sophistication a

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

nd formality vary considerably. Conceptually, strategic planning is deceptively simple: analyze the cu

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

Examples of combination products may in

rrent and expected future situation, determine the direction of the firm and develop means for achievi

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

ng the mission. In reality, this is an extremely complex process, which demands a systematic approach

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

or identifying and analyzing factors external to the organization, and matching them with the firm?s c

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

Combination pro

apabilities.

Planning is done in an environment of uncertainty. No one can be sure what the external

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

as well as the internal environment will be even next week, much less several years from now. Therefor

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

e, people make assumptions or forecasts about the anticipated environment. Some of the forecasts becom

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

assumptions for other plans.

Strategies and policies are closely related. Both give direction, both

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

are the frameworks for plans, both are the basis for operational plans and both affect all areas of ma

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

naging. Although specific steps in the formulation of the strategy may vary, the process can be built,

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

Following aspects would a

at least conceptually, around the key elements like purpose and objectives, external environment and

dd to the challenges in developing combination products:

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

nternal environment.

Strategic alternatives are developed on the basis of an analysis of the external

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

and internal environment. An organization may pursue many different kinds of strategies. It may speci

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

alize or concentrate. Alternatively, a firm may diversify, extending the operation into new and profit

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

able markets. Still another strategy is to go international and expand the operation into other countr

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

Professional from academic institutions, pharmaceutical industries, health care indust

es. Under certain circumstances, a company may have to adopt a liquidation strategy by terminating an

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

unprofitable product line or even dissolving the firm. But in some cases, liquidation may not be neces

.

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

sary and a retrenchment strategy may be appropriate. In such a situation, the company may curtail its

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

Companies that provide selfless information through particip

operation temporarily. The various strategies have to be carefully evaluated before the choice is made

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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