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The Disability Discrimination Act 1995 Part Three applies to all "service

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

s Providers" that is, anyone who provides goods or services to the public

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

Examples of combination products may in

whether for profit or not. Accordingly, the scope of the DDA is enormous

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

, covering for example churches, retailers, schools, leisure facilities &

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

hospitals.

DID YOU KNOW?

On 2nd December 1996 it became unlawful for se

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

Combination pro

rvice providers to treat a disabled person less favourably than a non-dis

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

bled person for a reason relating to their disability.

ARE YOU AWARE?

S

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

ince 1st October 1999 Service Providers have been obliged to:

- Alter pr

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

ctices, policies or procedures that make it impossible or unreasonably di

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

fficult for a disabled person to use their services; and

- Provide Auxil

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

ary Aids or services to assist a disabled person to access their services

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

Following aspects would a

WHAT ARE YOU DOING NOW?

Since 1st October 2004 Service Providers are o

dd to the challenges in developing combination products:

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

bliged to have made reasonable adjustments to any physical features of th

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

ir premises which present a barrier to access for disabled people. This m

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

ust be done by altering, removing or adjusting building features, or by p

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

oviding a reasonable means of avoiding a feature which presents the barri

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

Professional from academic institutions, pharmaceutical industries, health care indust

er to access.

If you are unsure whether the DDA 1995 affects you and you

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

business and need further information then you can contact us at

.

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

et="_new" href="http://www.centralsafetyconsultancy.co.uk">http://www.cen

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

Companies that provide selfless information through particip

ralsafetyconsultancy.co.uk and someone will more than happy to help

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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