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Partnership refers to an artificial being brought about by the expedient act of collaborating or

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

pooling of interests, industry or capital of at least two or more persons intended primarily 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

serve or perform a particular business undertaking or enterprise. In a partnership set up, part

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

ners act as agents of each other and of the partnership. Each partner is bound by the acts and r

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

epresentations made by their co-partners in dealing and transacting with third persons.

Partner

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

Combination pro

ship formation may take various forms depending on how the partners agree to create it and to ca

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

rry out their objects and purposes. There are no fixed parameters and strict formalities as rega

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

rds the formation of a partnership. The king of partnership established relates closely to the k

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

ind of liability a partner is assuming. As a general rule, the liability of the partnership is l

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

ikewise the personal liability of each and every partner. However, partnership agreements may sp

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

ecify the kind liability undertaking that each of the partners is bound to assume. A partner may

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

Following aspects would a

have a limited liability only which means he is not bound to answer for the liabilities of the

dd to the challenges in developing combination products:

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

partnership beyond his interest or contribution. He cannot be held personally liable for partner

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

ship debts. In partnership however, it is a settled rule that despite the concept of limited lia

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

bility, a partnership should always have at least one general partner to shoulder the partnershi

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

p liability at his personal expense.

Moreover, a partner may contribute not only money or capit

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

Professional from academic institutions, pharmaceutical industries, health care indust

al contribution. He may likewise put in his industry in the partnership. Unlike a general partne

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

r, an industrial partner cannot be held personally liable for partnership obligations. But despi

.

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

te the multifaceted liabilities of each and every kind of partner comprising a partnership, part

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

Companies that provide selfless information through particip

nership creditors as well as third persons dealing with the partnership remains fully protected.

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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