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Subjects - Anti-Dumping and International Trade
Dumping takes place when a company sells goods at a lower price in the foreign market then the price it charges in its domestic market. This is an unfair trade practice which can have a distorted effect on international trade.
There are two fundamental parameters used for determination of dumpi
There are two fundamental parameters used for determination of dumpi
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
ng, namely, the normal value and the export price. Both these elements have to be compared at the same level of trade, generally at ex-factory level, for assessment of dumping.
The normal value is generally the price of the product at issue, in the ordinary course of trade, when destined for co
; 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
sumption in the exporting country market.
Export price of goods means the price at which the goods are sold to importing country. It is generally the cost, insurance and freight (CIF) value minus the adjustments account of ocean freight, insurance, commission etc. so as to arrive at the value o
Export price of goods means the price at which the goods are sold to importing country. It is generally the cost, insurance and freight (CIF) value minus the adjustments account of ocean freight, insurance, commission etc. so as to arrive at the value o
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ex-factory level.
There is nothing inherently illegal about dumping as long as it does not cause material injury to domestic industries. However, when dumping causes or threatens to cause material injury to the domestic industry, the anti-dumping authorities initiate necessary action for inves
There is nothing inherently illegal about dumping as long as it does not cause material injury to domestic industries. However, when dumping causes or threatens to cause material injury to the domestic industry, the anti-dumping authorities initiate necessary action for inves
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
igations and subsequent imposition of anti-dumping duties.
Under Article VI of GATT 1994, and the Anti-Dumping Agreement, WTO Members can impose anti-dumping measures, if, after investigation in accordance with the Agreement, a determination is made (a) that dumping is occurring, (b) that the d
Under Article VI of GATT 1994, and the Anti-Dumping Agreement, WTO Members can impose anti-dumping measures, if, after investigation in accordance with the Agreement, a determination is made (a) that dumping is occurring, (b) that the d
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
mestic industry producing the like product in the importing country is suffering material injury, and (c) that there is a causal link between the two.
However, in order to take anti-dumping action, anti-dumping authorities have to show that dumping is taking place, calculate the extent of dumpi
However, in order to take anti-dumping action, anti-dumping authorities have to show that dumping is taking place, calculate the extent of dumpi
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
g, and show that dumping is causing injury or threatening to do so to the domestic industries.
Therefore, the agreement clearly lays down the principle that anti-dumping duties on dumped imports cannot be levied solely on the ground that a product is being sold at a lower price to the importing
Therefore, the agreement clearly lays down the principle that anti-dumping duties on dumped imports cannot be levied solely on the ground that a product is being sold at a lower price to the importing
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
country. They can be levied only if it is established, that the dumping is causing material injury to that industry.
Broadly, injury may be analyzed in terms of the volume effect and price effect of the dumped imports. The parameters by which injury to the domestic industry is to be assessed i
Broadly, injury may be analyzed in terms of the volume effect and price effect of the dumped imports. The parameters by which injury to the domestic industry is to be assessed i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
the anti-dumping proceedings are such economic indicators having a bearing upon the state of industry as the magnitude of dumping, and the decline in sales, selling price, profits, market share, production, utilization of capacity etc
Anti-dumping action involves charging extra import duty i.e
Anti-dumping action involves charging extra import duty i.e
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
anti-dumping duty on the particular product that is being exported from a particular country in order to bring its price closer to the domestic price or to remove the injury to the domestic industry in importing country.
Under the GATT provisions, anti-dumping duties cannot exceed dumping marg
Under the GATT provisions, anti-dumping duties cannot exceed dumping marg
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
n. However, it is suggested to impose a lesser duty, which is adequate to remove the injury caused to domestic industry. Under Indian laws, the authorities are obliged to restrict the anti-dumping duty to lower of the two i.e. dumping margin and injury margin.
Any exporter whose margin of dumpi
Any exporter whose margin of dumpi
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
g is less than 2% of the export price shall be excluded from the purview of anti-dumping duties even if the existence of dumping, injury as well as the causal link is established
Extensive investigation against any country is required to be terminated if the volume of the dumped imports, actual
Extensive investigation against any country is required to be terminated if the volume of the dumped imports, actual
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
or potential, from a particular country accounts for less than 3% of the total imports provided the cumulative imports from all those countries who individually account for less than 3%, are not more than 7%.
Furthermore, it is imperative to prove that the dumping has caused injury to the domes
Furthermore, it is imperative to prove that the dumping has caused injury to the domes
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
ic industry.
Disputes in the anti-dumping area are subject to binding dispute settlement before the Dispute Settlement Body of the WTO, in accordance with the provisions of the Dispute Settlement Understanding ("DSU") (Article 17).
Members may challenge the imposition of anti-dumping measures,
Disputes in the anti-dumping area are subject to binding dispute settlement before the Dispute Settlement Body of the WTO, in accordance with the provisions of the Dispute Settlement Understanding ("DSU") (Article 17).
Members may challenge the imposition of anti-dumping measures,
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
in some cases may challenge the imposition of preliminary anti-dumping measures, and can raise all issues of compliance with the requirements of the Agreement, before a panel established under the DSU.
Apart from dumping, some of the countries also resort to subsidization of their exports to o
Apart from dumping, some of the countries also resort to subsidization of their exports to o
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
her countries. Export subsidies, under the WTO agreement, are treated as unfair trade practice and such subsidies are actionable by way of levy of anti-subsidy countervailing duty. However such duties can be levied only if preliminary investigations have established that subsidization is actuall
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
taking place.
The Agreement on Safeguards authorizes importing countries to restrict imports for temporary periods, if after investigation it has been established that imports are causing serious injury to the domestic industry. Safeguard measures include increasing tariffs over bound rates or
The Agreement on Safeguards authorizes importing countries to restrict imports for temporary periods, if after investigation it has been established that imports are causing serious injury to the domestic industry. Safeguard measures include increasing tariffs over bound rates or
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
imposing quantitative restrictions.
Anti-dumping & Anti-subsidy cases in India
The countries prominently figuring in the anti-dumping investigations by India are China PR, EU, Chinese Taipei, Korea RP, Japan, USA, Singapore, Indonesia, Thailand, Russia etc. Investigations were carried i
Anti-dumping & Anti-subsidy cases in India
The countries prominently figuring in the anti-dumping investigations by India are China PR, EU, Chinese Taipei, Korea RP, Japan, USA, Singapore, Indonesia, Thailand, Russia etc. Investigations were carried i
.
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
188 cases from various sectors like Chemicals and Petrochemicals, Pharmaceuticals, Textiles, Steel and other materials, Consumer goods etc. involving 35 countries/ territories.
EU, US, Canada and South Africa account for almost 60% of anti-dumping cases initiated against Indian exports.
India
EU, US, Canada and South Africa account for almost 60% of anti-dumping cases initiated against Indian exports.
India
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
exports are also facing number of anti-subsidy cases by other member countries of WTO. EU, USA and South Africa account for 83% of the anti-subsidy cases initiated against Indian exports.
For reading other articles, please visit at: http://www.tradeindia.com/newsletters/newsletter_archives.htm
For reading other articles, please visit at: http://www.tradeindia.com/newsletters/newsletter_archives.htm
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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