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Some electricians are cashing in on the confusion over last year’s new electrical regulations for re

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

nted and private property.

No obligation for annual inspection
Less reputable ‘sparkies’ are c

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

Examples of combination products may in

laiming that full routine tests on electrical wiring are now compulsory in rented properties. This

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

is not true. Part P of the Building Regulations, introduced in January 2005, means that most electr

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

ical jobs have to be inspected and approved by either the local authority or a certified electrician

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

Combination pro

.

There is however no statutory obligation on landlords or agents to have professional checks carri

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

ed out on the electrical system or appliances. However, under the Electrical Equipment (Safety) Regu

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

lations 1994, the Plugs and Sockets etc. (Safety) Regulations 1994, both of which come under the Con

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

sumer Protection Act 1987, there is an obligation to ensure that all electrical equipment is safe.

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

What do landlords need to do?
To stay within the law your main obligations are to take reasonab

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

le steps to ensure that the electrics and appliances are safe. To do this we recommend:

* Annual v

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

Following aspects would a

isual inspections by the landlord or agent - recording this on a safety checklist,

* Inspections on

dd to the challenges in developing combination products:

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

tenant change-overs, recording electrical equipment, its condition and fuses fitted

* Periodic ins

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

pections of electrical equipment by a qualified electrician.

* A ten year inspection by a qualified

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

electrician to ensure safety and that the electrical system complies with current electrical regula

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

tions. Five years is good practice.

* Keep all records of these inspections.

* This should ensure

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

Professional from academic institutions, pharmaceutical industries, health care indust

that obligations are met and that a ‘defence of due diligence’ can be made should unforeseen circums

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

tances occur.

Small claims
Landlords that have already been panicked into paying for an unnece

.

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

ssary inspection could even consider issuing a ‘small claims’ summons for the return of their money

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

Companies that provide selfless information through particip

on the basis of misrepresentation of the building regulations; one specialist adviser has commented.

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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