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When CyberMedia News reported on the recent phishing attack on ICICI customers one thing that stood out was that it was c

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

onducted in a highly sophisticated and well-planned manner. http://www.ciol.com/content/news/2006/106021019.asp

The perp

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

Examples of combination products may in

trators had completely replicated ICICI Bank's net banking website hoping to get account holders to reveal their access 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.

formation. It was an alert customer that brought the fraud to the bank’s notice. To its credit, ICICI acted quickly and m

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

inimised the damage.

One of the reasons the bank could contain the damage early was that it had a robust Risk Containmen

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

Combination pro

unit, which went into overdrive. The fraud was identified quickly, the damage control was swift and the perpetrators wer

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

nabbed within a few days.

Fraud is not restricted to the banking, finance or retail industry. Every organization is sus

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

ceptible. This time ICICI bank was the victim, but tomorrow any organization could be the target.

Madhabhi Puri Buch, se

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

ior general manager, ICICI Bank, noted that private banks in India have implemented processes to combat such crimes. Whil

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

it is true that most organizations have implemented some measures in part, clearly defined Risk Mitigation Policies in t

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

e Indian business scenario are still a minority.

Risk can enter an organisation through only two doorways: people and pr

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

Following aspects would a

ocesses. Organizations are realizing the value of pre-employment screening, vendor reference checks and internal audits a

dd to the challenges in developing combination products:

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

effective risk management tools. The question is, is that good enough?

With increasing sophistication in internal and e

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

ternal fraud, organisations must transcend their comfort zones and rely more on prevention than on post mortems.

A compr

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

ehensive risk management policy would encompass various types of potential internal and external risks, the measures to c

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

ntrol them, and the damage control process if the organization faces a real risk situation.

This not only readies the or

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

Professional from academic institutions, pharmaceutical industries, health care indust

anization to take swift action, based on predefined risk triggers, but also sends a clear message to its internal and ext

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

ernal stakeholders, that the enterprise is alert to possible risks.

The episode at ICICI Bank cannot be taken in isolati

.

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

n. It is just a sign of things to come. According to the Anti-Phishing Working Group's website, phishing is on the increa

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

Companies that provide selfless information through particip

e in India.

Its time to ask yourself how vulnerable your organisation is, and whether it is geared to deal with the risk

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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