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Auto insurance rules differ from one state to another. These rules lay down specific guidelines with respect to types of coverage to be included in the

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

insurance policy as well as the minimum amount that one should allocate under each coverage head.

The follwing is a brief outline of just how auto insu

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

Examples of combination products may in

rance works in Texas. Texas is a ‘tort state’ which means that you are responsible for the injuries you cause as a result of an accident. Therefore you

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

have to have a proof of how you are going to pay up should you be involved in an accident. This obviously means that you have to have an auto insurance

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

which has more than the minimum coverage. Hence minimum liability insurance is a must in Texas. The liability cover has to be a minimum of $20,000 per i

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

Combination pro

ndividual for bodily injuries that you cause to the other persons(s) and up to $40,000 for all. Apart from that, you have to be adequately covered to en

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

able you to pay $15,000 for damage you cause to the other party's personal property in the accident.

The Texas Personal Automobile Policy regulations o

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

ffer eight types of coverage. By law you are required to have basic liability coverage. The other seven types are optional. If you are leasing or financ

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

ing a new car however, dealers may require that you have collision and comprehensive coverage as well.

Penalties for violating the states’ financial re

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

sponsibility laws are severe. A fine of $175 and $350 may have to be paid by the first time offender. For subsequent convictions $350 to $1,000 could be

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

charged. Apart from this, the driver’s driving license can be suspended or, worse still, the automobile can be impounded by the authorities. To avoid t

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

Following aspects would a

his one has to carry the proof-of-insurance card at all times and produce for scrutiny on demand by law enforcement officer. This card is sent to the in

dd to the challenges in developing combination products:

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

surance policy holder after he purchases an automobile insurance.

Texas auto insurance law requires that rates for insurance offered in the state be re

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

asonable but adequate. At the same time they should not be excessive to the risks for which they apply, and definitely not unfairly discriminatory. The

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

law also allows the insurance companies to give discounts to people with lower risk and freedom to charge a higher premium for high risk individuals. Fo

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

llowing are some of the reasons which can cause your insurance premium to go up or come down.

Age and marital status: Lower age and ‘unmarried’ marital

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

Professional from academic institutions, pharmaceutical industries, health care indust

status can attract a higher premium as they are considered more risky drivers.

Driver’s driving record: No accidents or tickets in the past can avoid

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

a penalty which is generally in the form of a surcharge.

Urban vs. Rural: If your car is kept in an area classified as rural you are likely to pay a le

.

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

sser premium compared to when you keep it in an urban surrounding. This is because in the former case, the automobile is less prone to theft.

Make of y

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

Companies that provide selfless information through particip

our car: Flashy, expensive cars are more theft prone compared to their lower end counterparts and hence may translate into higher premium for its owner.

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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