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Like many natural wonders that have caught the attention of global tourism, coral reefs could be suffering from too much interest. As well meaning tourists and water-s

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

ports enthusiasts, we descend in our thousands if not millions on and under the world’s tropical and coastal waters. Unfortunately, the damage we leave behind is leavi

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

Examples of combination products may in

ng it's mark. Marine life, and the sea on which we depend, surf, swim and dive in, is under threat from pollution, tourism, over-fishing and other damaging activities.

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

Coral and coral reefs are extremely sensitive, just walking on a reef can damage fragile coral that will take years to regrow. Many coral reefs are constantly being d

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

amaged by cruiseship anchors, legal and illegal spillage, sewage, tourists breaking off chunks of coral as a keep sake (however small) and commercial harvesting for sa

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

Combination pro

le to tourists and vacation divers like us. It is not unusual for tourist resorts to empty their sewage directly into the water surrounding coral reefs and thereby con

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

ributing to coral reef degradation.

With the help of small polyp like creatures and microscopic algae it takes nature thousands of years to create a coral reef. We ca

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

n carelessly destroy it in the blink of an eye. Coral reefs could be called the rainforests of the ocean, they are reservoirs of biodiversity. They are a rich natural

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

resource - a vital ecosystem. There are some 800 species of coral which, in the form of reefs, are home to an estimated 4,000 species of fish. In the last couple of de

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

ades some 35 million acres of Coral Reefs have been destroyed.

Hitting the bottom

A recent survey of the Gulf of Gascony found that in the survey ar

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

ea, to a depth of 200m, the ocean floor was awash with litter and man made junk. The survey idenitfied approx 50 million individual items of rubbish, a large percentag

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

Following aspects would a

e of which was plastic material (nonbiodegradable). This debris is potentailly lethal for marine life and birds caught up in it.

The presence of litter such as plasti

dd to the challenges in developing combination products:

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

bottles, crisp wrappers and sewage related debris on beaches and at sea is unattractive, has health and economic impacts on local communities, and is potentially harm

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

ful to marine wildlife through entanglement and ingestion.' [Marine conservation society]

Hundreds of thousands of sea turtles, whales and other marine mammals die ev

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

ery year from eating discarded plastic bags mistaken for food

Plastic bags don't biodegrade, they photodegrade: they break down into smaller and smaller toxic bits, c

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

ntaminating soil and waterways, and enter the food chain when animals accidentally ingest the waste

Plastic bags are among the 12 items of debris most often found in

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

Professional from academic institutions, pharmaceutical industries, health care indust

coastal cleanups, according to the nonprofit Center for Marine Conservation

What can we do

Today 70% of the coral is threatened either by humans dir

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

ectly or through the effects of pollution and climate change. It is unlikely that this disregard for our coral reefs will stop any time soon. Next time you’re on vacat

.

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

on just think how you can make a difference.

Say no to coral souvenirs, coral curios and jewelery

Watch where you put your feet, flippers can cause havok to a fragil

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

Companies that provide selfless information through particip

e reef

Watch where you drop anchor

Don't drop your rubbish. Take it home with you. Floating litter can cover reefs, blocking off sunlight that polyps need to survive

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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