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The characteristics of present banking system is exposed to diverse market and non-market risks, which has put risk management in these sectors to a core functionary within the financial institutions. This has been essentially done to prot

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

ect not only the interests of the stakeholders, but more obviously, in protection to the shareholders and creditors. The growing economy demands a safe and sound banking system, and as such, risk management has become a critical task for t

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

Examples of combination products may in

he banking sectors, bringing in stability in the financial markets. A good supervision of all the factors involved, would lead to identifying, assessing, and promoting a secured risk management system.

The banking sector is increasingly f

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

aced with tougher challenges in meeting various risk management requirements, and no matter how tough it is, the present day operations requires the risk managers to be vigilant, and unusually diligently perceptive towards the causes of pr

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

tecting the interest of the people concerned. In the practical scenario, risk management is very much fragmented, spread across in pockets, resulting in inconsistency in reporting, inadequate measurements, and poor quality of management. P

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

Combination pro

oor data availability is one of the major causes in inefficient risk management, making it difficult for the bank to manage and control in an institution-wide environment.

In order that a consolidated step could be taken towards a better

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

risk management, there has been much interaction between the public and private sectors, with an attempt to evolve techniques, mostly pertinent to the banking sector, which represents the largest and most internationally active industry in

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 world. Through these deliberations, Basel Committee (BCBS) in Basel, Switzerland, in 1988, came out with Basel I framework proposal, which brought together closer ties between the banks' capital holding, and the risks that are involve

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

. This brought in higher capital level. The banking sector is growing rapidly, and with its large and complex operations, Basel I have become inadequate in continuing with the improvement of the advanced method of risk management that the

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

banking sectors have today. A more comprehensive guideline was evolved in Basel II. This regulation envisaged that, the banking sector should ensure a proper handling of the capital, separate the operational risk from the credit risk while

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

quantifying both, and distribute capital vis-?-vis the economic risk. We shall discus Basel I and Basel II in a little more detail in the articles to follow.

The basic concept of risk management involves making an assessment of the risk

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

Following aspects would a

and then developing a strategy to manage that risk. Risks ensuing out of physical or legal causes, such as, natural disasters or fires, accidents, death, and lawsuits, are one of those which are traditionally focused. But, in banking secto

dd to the challenges in developing combination products:

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

s, the focus is mainly on risk factors involved with traded financial instruments. In an ideal situation, the risks concerned with substantial losses and the high probability of its occurrence, are handled first, and given the highest prio

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

rity in risk management. The lesser probable ones comes next. In doing so, it is quite difficult to maintain the balance between the combination of different scenarios, viz., risks with a high probability of occurrence but lower loss vs. a

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

risk with high loss but lower probability of occurrence.

In meeting the basic characteristics in banking sectors, there is a need to provide human and financial resources through-out the organisation, enough to meet the purpose of an eff

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

ective compliance risk management system. In proving such resources, it is necessary to delegate proper authority and independence in the working method. There needs to be a sense of 'ownership' in the compliance function, in order that th

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

Professional from academic institutions, pharmaceutical industries, health care indust

organisation can keep itself focused on its compliance risk management responsibility. A comprehensive database should be in place, along with monitoring and measuring of the risks involved in any kind of circumstances, which, in combinat

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

ion, may provide meaningful reports based on the laws and regulations governing compliance risks, associated with existing or new products, and new business activities.

The banking sector need to understand operational risk exposure at th

.

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

e organisational level, where the concerned risk factors are consolidated into one, making it somewhat easier to have a verification of operational risk involved. We shall examine in the consequent articles the problems that banking sector

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

Companies that provide selfless information through particip

finds most difficult to address, which are deficient in the current methodology used. There are gaps in analysis of risk elements in the current procedures adapted, in establishing risk management and risk control.

prabirsenuk@yahoo.co.u

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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