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Almost every organization is faced with the necessity of laying off employees for lack of work. S

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

ome layoffs are temporary and are expected by employees because of the nature of the job. These l

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

Examples of combination products may in

ayoff can be planned for and may not be serious. In contrast, a change in operations or decline i

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

business necessitates permanent layoffs. All of these involve employee separation from the organ

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

ization. Separation may also arise from employee resignations and retirement.

Layoff can be defi

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

Combination pro

ed as an indefinite separation from the payroll due to factors beyond the control of the individu

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

al. The causes of layoff include decline in sales, shortage of raw materials, market fluctuations

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

delays in production and displacement caused by technology. Layoff is a temporary separation whe

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

n it is initiated by an employer. But some times, it turns out to be permanent when production ne

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

er picks up. Layoff is considered to be a serious issue because of the involvement of human senti

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

ments and adjustment problems.

Seniority rule may be followed for layoff, as often demanded by u

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

Following aspects would a

nions. When seniority is explicitly stated as the primary factor, long-service employees know tha

dd to the challenges in developing combination products:

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

they will not be the first to go if operations decline, and they have a pretty good idea of what

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

to expect in the future.

Seniority is a highly complex issue. It is perplexing issue to determi

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

e what type of seniority should be used during layoff periods. Obviously, the union stresses the

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

company wide seniority system. In cases where this type of seniority is used, the long service em

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

Professional from academic institutions, pharmaceutical industries, health care indust

loyees are bumping the short service employees if they are capable of doing their work. As this p

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

rocess disrupts the efficiency of the company, management usually stresses the departmental or un

.

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

t seniority. Seniority is also used as a basis of recall when business picks up and the workforce

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

Companies that provide selfless information through particip

expands. The workers may be reemployed in inverse order of layoff or in terms of their seniority

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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