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IMPORT POLICY

The following is a brief overview of the import, importing and imports how too. It is not meant to be a definitive explanation. O

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

nly as an interest peaking point concerning the import topic.

For items not mentioned as being import Prohibited, Restricted or Canalized List

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

Examples of combination products may in

for import in ITC(HS) Classification of Export and Import items; import of such items are freely permitted. There is no need to obtain any impor

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 license or permission for importing such goods. The ITC (HS) Classification of Export and Import items contain 99 chapters and in each chapter

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

there are column heading covering Exim Code, items description, policy and nature or restriction. The information related to import policy for a

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

Combination pro

ny item can be obtained from our site under Customs Duty Calculator Schedule.

Selecting the commodity and/or product you want to import, be awa

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

e of the import potential and the commercial viability of the commodity/product.

Check whether the items of your import interest fall in the re

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

stricted list of ITC (HS) Classifications of Exports & Imports items. Prohibited (import) items are not permitted to be imported at all. List of

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

Prohibited items of import are detailed below: Tallow, Fat or Oils rendered, unrendered or otherwise of any animal origin, animal rennet and w

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

ild animals including their parts and products and ivory any part and products, including ivory.

For import of items appearing in restricted li

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

t you need secure import license. Third category of items comes under the Canalized list of items. Import of items included in Canalized list is

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

Following aspects would a

permitted to be imported through Canalizing Agencies. Thus items not appearing in Prohibited list, restricted list and or in Canalized list c

dd to the challenges in developing combination products:

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

n be imported freely without any import license. A large number of Consumer goods are free for import without license

The procedure to be follo

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

wed to import is this. Bill of Entry must be filed in the prescribed form by the Import or his authorized agent giving the prescribed details su

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

h as name and address of the importer, importer code, name address and license number of the Custom House Agent, name of vessel, Rotation Number

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

and date, Line Number, port of shipment, country of origin, country of consignment, number of Bill of Lading, description of packages, number o

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

Professional from academic institutions, pharmaceutical industries, health care indust

packages, quantity of goods, description of goods, Customs Tariff Heading, details of exemption from customs duty claimed, invoice number, and

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

value, etc. A declaration that the details are true and there is no other document showing contrary information must also be given. The Bill 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

ntry may be signed by the importer himself or his Custom House Agent.

You have just seen a very very brief article about how to go about taking

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

Companies that provide selfless information through particip

part in the import arena. Import work and/or activities can be fun, profitable and Simple. It is not as hard as some would make you think it is

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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Throughout history, man has invented tools and devices to make their daily tasks easier. Things that we take for granted today, such as paper, electricity, indoor plumbing and just about every item found in our lives had to be invented by someone. Most inventions hold a large importance in our daily lives yet others become obsolete and unimportant.

While evaluating a business opportunity check out the competitors. See if you can find out who is Number One and shop that company. The best competitor should be your model and the people who run it should be your mentors

Customer decides not to do anything. This is the greatest overlooked type of competition.There must be a high degree of urgency to convince someone to buy something.

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