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Depending upon the way in which we choose to view it, the strengths or weaknesses of the concept of social entrepreneurship lie in the fact that most of its applications are in the form of a hybrid between private, non-profit and public se

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

ctors. As described, one such hybrid is found in non-profit organisations with an entrepreneurial offshoot that generates revenue for the organisation’s social objectives. With greater emphasis on the private, for-profit sector, a hybrid m

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

Examples of combination products may in

del is emerging whereby businesses lend money and expertise to non-profits. Increasingly, this latter model is linked to public pressure for businesses to demonstrate a measure of social responsibility.

The most realistic and desirable wa

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

for any business to be socially responsible is through what is called ‘‘strategic philanthropy’’ - selected giving in areas tied directly to the company’s interests and in arenas that the company can justly claim to have knowledge and a d

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

rect stake. The use of the term clearly suggests an indirect financial return on the philanthropic investment. Indeed, the exercise of traditional philanthropy does not make good business sense as it does not provide a tangible return. In

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

Combination pro

more refined consideration of types of philanthropy today, the notion of strategic philanthropy yet emphasises that highly motivated and visionary business leaders can bring together networks of organizations in new community ventures.

L

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

ike the term ‘‘strategic philanthropy’’, ‘‘social entrepreneurship’’ is an articulation, a combination of two concepts that do not naturally fit together and yet which seeks acceptance as common sense. It is the lack of a natural fit that

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

enders the term open to resistance and challenge. Challenges, implicit or explicit, range from different interpretations of how the terms might justifiably be joined to denial that they should be used together at all.

Language is a key co

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

ponent in the shift towards rationalization of the concept of social entrepreneurship. This is because discourse acceptance precedes or runs in parallel with material acceptance. Thus we see the emergence of terms that were previously rest

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

icted to the business sector, such as ‘‘social venture capital’’, ‘‘social return on investment’’, ‘‘invest’’ rather than ‘‘donate’’, ‘‘revenue streams’’ and ‘‘client groups’’ applied to the social and public sectors.

If the colonisatio

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

of the social and public sectors by the language of business is accepted, the breakdown of barriers between the sectors becomes normalised. However, the terms cited are in contrast to the distinction between entrepreneurs who create socia

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

Following aspects would a

l or artistic capital rather than financial capital, with social capital referring to that which is valuable to communities.

On the other hand, opposition could arise from the close association of the term ‘‘entrepreneur’’ with the creati

dd to the challenges in developing combination products:

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

e and destructive aspects of capitalism. Those who are concerned about the negative aspects of business will be resistant to the blurring of the boundaries between public, private and civil society suggested by social entrepreneurship with

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

the potential for increased influence of business beyond the private sector. The non-profit sector has long been associated with the creation and maintenance of a strong civil society. Marketing of that sector then calls that association i

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

to question with concerns for the viability of an independent civil society.

Furthermore, if business has the power to choose which non-profits are to benefit materially through socially entrepreneurial partnerships, what happens to those

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

that are not chosen and therefore are marginalised?

A parallel can be drawn between the concept of social entrepreneurship and that of sustainability because sustainability is equally open to broad interpretation. Like social entrepreneur

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

Professional from academic institutions, pharmaceutical industries, health care indust

ship, sustainability can favour either the social and environmental or the economic sectors, depending upon which model is adopted. Strong sustainability favours the social and environmental over economic development, upholding the social

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

alues of a truly civil society based social entrepreneurialism. Interpretations are derived from the beliefs and experiences of individuals. Social entrepreneurs and their work should ultimately be judged by the quality of the social outco

.

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

es, and that assessment should be made independently of the private interests of those entrepreneurs.

With concepts and movements such as social entrepreneurship, environmental sustainability, and social responsibility, it is crucial that

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

Companies that provide selfless information through particip

we pay close attention to the persuasive uses of the terms as well as to their practical implication. All of them are contested, value-laden labels that can be used to reference a wide variety of interests, motives, activities and outcomes

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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