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The Consumer Protection Act has been introduced to protect the consumer from the seller of the goods & services.Its ob

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

jective is to provide a simple,speedy and inexpensive way of redressal of grievances in case of any deficiency/defect

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

Examples of combination products may in

n goods and services bought/used by him for a consideration.

Who is a Consumer:A consumer can be a consumer for goods

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

or consumer for services.A consumer is one who buys some goods for consideration for his use or one who uses such good

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

with approval of such buyer.The buyer who buys goods and uses the same for commercial purpose can not claim protectio

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

Combination pro

under the Act but a consumer of services even if he utilises it for commercial purpose can be safeguarded by the act.

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

OBJECTIVE:The sole purpose of the act is to protect ordinary consumers purchasing goods for their own consumption.

I

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

PORTANCE:In internet marketing business its requirement and effectiveness are enormous.The consumer purchase goods or

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

ervices through image on the screen and trust the specification made by the seller.The buyer can not touch physicall

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

before getting delivery of goods and services.Now in case if the goods/services inconformity with the specification,p

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

otection should be provided to the buyer through establishment of special court and introduction of special legislatio

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

Following aspects would a

n.

NEEDS TO CHANGE BUSINESS PATTERN:In future internet marketing will have to be encouraged at any cost.Population of

dd to the challenges in developing combination products:

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

every country has been increasing day by day.so every country has been suffering to provide the space for business act

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

vities particularly in city and urban areas.If the internet marketing is augmented,no show room need not to be establi

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

hed.This enables city authorities to open various types of business to satisfy the human needs.

REMEDIAL MEASURES:I

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

order to provide legal protection to the e-consumer of goods and services an on-line judicial system should be establ

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

Professional from academic institutions, pharmaceutical industries, health care indust

shed.one can file writ,appeal other petitions on line and copies of the orders can be obtained electronically.This p

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

ocess will expedite justice and e-consumer will get confidence to purchase more and more and it will be an internet ma

.

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

keting boom.

WEAKNESS:But in most of the third world countries this act has lost its effectiveness.The administration

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

Companies that provide selfless information through particip

of that country should be serious to implement the law correctly and make the new business world in the 21st century

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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