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Advice You - Precautions For Protecting Local Industry From The International Industry
With the world becoming smaller and repeated references to the global village syndrome, people feel that it’s not long before the borders of trade become
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
totally transparent. While this is a positive in many ways, particularly for the global consumer, there are downsides. For one thing, with the influx of s
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
llers from the world over, the local industry comes into direct competition with the international industry. While some contend that this will bring local
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
industry on par with international industry, the truth is that many local sellers feel threatened by the change. Costs of production in one area may vary
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
greatly from those of another area, and if businesses from the 2 areas come head to head, this will be an important determining factor for the survival of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the high production cost business. Some of the ways regulators and business people have thought to protect and foster growth in local industry are below.
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
Tariffs on imports –
The local industry has the option of lobbying for tariffs to be applied on the import of products and services into the countr
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
y. There are many ways to tax these international businesses so that the costs come to par with local industry. Due to the cost of transporting products,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
his also happens naturally in many cases – the cost of shipping may be prohibitive on an auto ancillary from Russia as opposed to one made in Detroit, tho
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
ugh the original price of the former may be much lower.
Subsidies –
The reverse concept is to grant subsidies for the local industry to grow and str
Subsidies –
The reverse concept is to grant subsidies for the local industry to grow and str
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ngthen itself to take on international industry players. This is only effective in the short term, however, and is somewhat controversial since subsidies
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
re normally considered fair for weak or infant industries.
Raise barriers to entry –
The trade council can raise the barriers for entry for a busine
Raise barriers to entry –
The trade council can raise the barriers for entry for a busine
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ss by imposing global standards. This means that the product must conform to international standards for it to be sold in the country, which means that th
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
quality improves and thus cost of the product increases.
Find USP for local products –
The local industry can also respond to this type of situatio
Find USP for local products –
The local industry can also respond to this type of situatio
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
n by creating need for local products. A special niche or a unique selling point of the local products means that there will be a specialized market for 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
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
and the product cannot be replaced by the international industry.
Join them –
If you can’t beat them, join them. Local industry can look for ways t
Join them –
If you can’t beat them, join them. Local industry can look for ways t
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
o partner with international industry, through individual sellers or as a whole, to ensure that everyone makes a profit. Many businesses are choosing to o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tsource some of their functions so that they ultimately make more profits.
However, there is a good side to global competition. It serves to protect the
However, there is a good side to global competition. It serves to protect the
.
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
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
local customer by reducing the possibility of monopolies within the local industry. But this is a matter to concern the government. So long as there are n
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
unfair trading practices that harm the consumer, the local industry needs to look towards maximizing profitability and competing in a global market place
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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