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Iron is an important mineral which enters into the vital activity of

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

the blood and glands. Iron exists chiefly as haemoglobin in the blood

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

Examples of combination products may in

. It distributes the oxygen inhaled into the lungs to all the cells.

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

t is the master mineral which creates warmth, vitality, and stamina.

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

It is required for the healthy complexion and for building up resista

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

Combination pro

nce in the body.

The chief sources of iron are grapes, raisins, spin

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

ch, all green vegetables, whole grain, cereals, dried beans, dark co

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

loured fruits, beets, dates, liver and egg yolk. The Indian Council o

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

f Medical Research has recommended an allowance of 20 to 30 mg. of i

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

on in a balanced diet for an adult.

Iron deficiency is generally cau

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

sed by severe blood loss, malnutrition, infections and by excessive

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

Following aspects would a

use of drugs and chemicals. Deficiency of dietary iron may cause nutr

dd to the challenges in developing combination products:

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

tional-anaemia, lowered resistance to disease, a general run down co

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

ndition, pale complexion, shortness of breath on manual exertion, an

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

d loss of interest in sex.

Iron is the classic remedy for anaemia. H

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

wever, there are several forms of anaemia, and iron deficiency anaem

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

Professional from academic institutions, pharmaceutical industries, health care indust

ia is only one. If one is taking iron pills due to insufficient intak

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

e of iron in the normal diet, one should also take atleast 40 mg. of

.

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

folic acid or folate every day, along with 10 to 25 mg. of vitamin B

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

Companies that provide selfless information through particip

12. Both these vitamins are essential in building healthy blood cells

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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