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Commissioner Of Customs, Bangalore Appellant

Versus

M/S. G.M. Exports & Others ...Respondents Civil Appeal No.3889 Of 2006

This case law is deals with anti damping duty under import goods. The question of law is
whether anti-dumping duty imposed with respect to imports made during the period between
the expiry of the provisional anti-dumping duty and the imposition of the final anti-dumping
duty is legal and valid. Article VI of the GATT agreement says duty levy on imported goods.
Because protect the domestic industry related with the product manufactured.

The final anti dumping duty effect come from when the duty levied under the act. Which
necessarily include the gap period. the period between the lapse of the provisional duty and
the imposition of the final duty According to learned counsel, levied in Rule 20(2)(a)
obviously does not include collection as has been held in several Supreme Court judgments
and therefore, levy would not include collection for which reason Rule 20 has to be read
on its own without reference to the consequence that is found in Rule 21. extending the
period of six months of the levy of provisional duty beyond six months and until the
notification imposing the final anti-dumping duty. So the andi dumping duty imposition on
import duty extern six month from the date of imposition.

2. Apar Private Ltd. And Others vs Union Of India And Others on 17 October, 1985

This case law is deals with demand exception under the goods clearance from the warehouse
60 %. Section 15 is says custom duty levied under the goods. customs duty under Section
12(1) is to be determined with reference to the date on which the goods enter territorial
waters of India was accepted. the date on which they are cleared for home consumption under
section15(1). The court point of view is section 15(1) is permitted to allow duty on imported
goods for home consumption

to be charged to duty as on the date on which a bill of entry in respect of such goods is
presented, and in respect of goods warehoused (on completion of the certain formalities as
laid down under Section 69, the goods could be removed from the warehouse on payment of
duty) as on the date of removal.
Strong reliance is placed by Mr. Dalal, learned counsel for Customs, on the decision of the
Supreme Court in Re Sea Customs Act (AIR 1963 SC 1760) to contend that the taxable event
occurs in the case of import of goods into India only when the stage for paying the import
duty is reached and without paying which the goods cannot be allowed to cross
the customs barrier . It is not a duty on property in the sense of Art. 289(1)." Do not give
exeption under the provisions

3. Lady Amphthil Nurses Instns And ... vs Cc, Chennai And Cc, Cochin on 22 August, 2002

This case law demand custom duty on import medical equipments .the hospital imported
goods Rs 1000 core .The authority who had issued the certificate, has the right to demand the
payment of customs duty. But the certificate fraduland one . after the authority cancelling the
licencing .the hospital demand 100 coroe duty exemption under this act but the court held that
do not claim the duty under the act.

4. Commissioner Of Customs (Import) vs Wockhardt Hospital And Heart ... on 28 April,


2006

Whether the importer escaped from the payment of custom duty which arose due to the
violation of post import conditions simply by declining to redeem the goods after they have
utilized them for their full life ? yhis mani question of this case.

VMr. Bharucha is provided levy of duty under section 12 of the custom act .but he is not
owner of the the goods or owner of the importer. The goods confisgated by the central
government This is because the taxable event in terms of Section 12 is the import into or
export of goods from India. The court held that Section 125 the person "shall in addition be
liable to any duty and charges payable in respect of such goods. It would not attract Section
28(1) of the Customs Act which covers the cases of duty not levied, short levied or
erroneously refunded etc. Therefore, there is a mandatory requirement on the adjudicating
officer before permitting the redemption of goods, firstly, to assess the market value of the
goods and then to levy any duty or change payable on such goods apart from the redemption
find that he intends to levy under Sub-section (1) of that Section". In this view of the matter
the objection raised by the Centre that Section 28 of the Customs Act would be attracted is
not sustainable.

5.Union Of India vs Jalyan Udyog on 14 September, 1993


This case laws deals with exemption duty under the custom:

6. Union Of India & Anr vs M/S Swiss Garnier Life Sciences & ... on 4 July, 2013

As par as in this case law deal with what are all include bulg drgs under cosmetic act 1940.

meaning of bulk drug, pharmaceutical, chemical, biological or plant product including its
salts, esters, stereo-isomers and derivatives should conform to pharmacopoeial or other
standards specified in the Second Schedule to the Drugs and Cosmetics Act, 1940. There are
75 bulk drugs here this case law says the particular medicine name Doxofylline whether it is
comes under bulk drug or not

Doxofylline as such has not been shown as one of the bulk drugs in the First Schedule of
the DPCO, 1995. Drugs and Cosmetics Act, 1940 provides Standards to be complied with
by imported drugs and by drugs manufactured for sale, stocked or exhibited for sale or
distributed so the court held that this medicine comes under bulk drugs also. Not only that
all salts, esters, stereo-isomers and derivatives of such bulk drug are, ipso facto, deemed to be
conforming to the pharmacopoeial or other standards accepted under
the Drugs and Cosmetics Act and are deemed to be bulk drug under DPCO, 1995.

7. State Of Rajasthan & Ors vs Vatan Medical & General Store & Ors on 26 March, 2001

This case laws deal with List III - Concurrent List Entry 19. Drugs and poisons, subject to the
provisions of entry 59 of List I with respect to opium. The state Entry 8 list II is to give
power to levy tax on imported goods . central government no power levy tax on the product.
But, the entire filed as far as drugs are concerned is covered by the Drugs and Cosmetics Act
1940.the decision was gave to through this case Balsara Vs. State of Bombay & Anr., 1951
SCR 682 iot is assigning o the expression intoxicating liquors as occurring in Entry 8
Schedule II so as to include therein even medicinal preparations, if alcoholic contents thereof
exceed a prescribed degree so as to be capable of being misused as beverage, was doubted in
Synthetics and Chemicals Ltd. Vs. State of U.P., (1990) 1 SCC 109 wherein it was observed
(vide para 74) that the decision of the Supreme Court in Balsaras case required
reconsideration. the expression intoxicating liquor has to be construed narrowly and therefore
Entry 8 of List II was not available for regulating manufacture, production, sale, transport,
etc. of medicinal preparations. The high court opinion could not be sustained by reference to
Entry 8 List II and there was no other power available to the State to regulate manufacture,
possession, sale, etc. of medicinal preparations. In the alternative, The Rajasthan High Court
also held that referable to Entry 52 List I, the Parliament had enacted the Industries
(Development and Regulation) Act, 1951. Drugs and Pharmaceuticals were listed as item 22
in the First Schedule of the Act. Chapter III of the ID & R Act empowers the Central
Government to regulate distribution, transport, disposal, acquisition, possession, use or
consumption of and sale or financial transactions relating to such articles as are specified in
the Schedule. Drugs and Cosmetics Act, 1940, to regulate the import, manufacture,
distribution by sale of drugs and cosmetics. By an amendment introduced by Act No.13 of
1964, this Act was made applicable to Ayurvedic or Unani systems of medicines also.
Exhaustive provisions contained in the newly added Chapter IV-A and the several sections
therein covered the entire field relating to Ayurvedic, Siddha and Unani drugs. Section 33
EED empowered the Central Government to prohibit manufacture, sale or distribution of any
Ayurvedic, Siddha or Unani drugs in public interest. Sale and distribution of drugs by retail
or wholesale and manufacture etc. were all taken care of by the Drugs and Cosmetics Rules,
1945 framed by the Central Government in exercise of the powers conferred by
the Drugs and Cosmetics Act, 1940. These drugs may be medicinal but they are capable of
and are being misused and consumed as beverages as they have alcohol content of over 25
degree proof. The sale of such medicinal drugs if manufactured properly and if not
misbranded, spurious or adulterated would not come within the ambit of Chapter IV-A and
Section 33 EEC of the 1940 Act but the sale of same can be controlled or regulated under the
ISP Rules. The provisions of Chapter IV-A of the 1940 Act do not, to our mind, overlap any
of the provisions of the Punjab Excise Act or the ISP Rules.

Factors affecting drug prices

There are a number of determinants affecting prices of internationally traded goods: these
include manufacturer or importer prices, price differences arising from inter-country
differences in import tariffs and non-tariff barriers and differences in procurement costs such
as transport, delivery costs, wholesaling, domestic taxes and other mark-up costs which can
differ considerably from one country to another. There are additional factors which
specifically affect pharmaceutical products such as price .
patented products according to market conditions in different countries or the presence of a
domestic pharmaceutical industry with the capacity to produce generic substitutes. An import
tariff is a customs duty imposed by importing countries on the value of goods
brought in from foreign countries. Tariffs are a vital determinant of prices as they can
considerably increase the prices of imported goods or locally produced goods incorporating
imported inputs. Tariffs may play a role in protecting the financial position of domestic
producers and generating government revenue. They vary greatly from one country to
another. This paper focuses only on tariffs. Recently as part of negotiations on the
implementation of TRIPS by the World Trade Organization (WTO), medicines were
recognized to be a special category of goods in the Doha Agreement. This study focuses on
tariffs as one component of medicine prices which may be amenable to international
agreements.

Exemptions

This paper analyzes tariff rates for different categories of pharmaceutical finished products,
active ingredients and vaccines for over 150 countries. It is important to note that tariffs on
pharmaceutical products are typically subject to a range of national exemptions, waivers or
reductions which differ significantly between countries, products and sectors. Krasovec and
Connor (1998) surveyed tax treatment of public health commodities in 22 developing
countries and found that purchases of contraceptives, vaccines and oral rehydration salts were
exempt from import taxes or subject to waivers for public sector buyers in 69-77% of
countries, for private non-profit buyers in 42-57% of countries, and for private-for-profit
buyers in 28-43% of countries, depending on the product in question. Partial reliefs or
Pharmaceutical Tariffs Olcay & Laing 9 May 2005 reductions were available in up to a
further 20% of countries. However, it is important to stress that the survey was sent to 50
countries but only 22 responded. There is currently no centralized international source for
extracting data on tariff exemptions for pharmaceutical products. Health Action International
(HAI) and the World Health Organization (WHO) are currently undertaking a project to look
at the various costs associated with the prices of medicines in different countries, including
tariffs. However, data is currently available for only a small selection of countries although
not all of the countries have collected price component data and much of the data is for patent
prices and
availability.
BACKGROUND

Prices of medicines is determined by a combination of variables, including national and


individual income, government policy, degree of competition in the public and private
markets, health system capacity, public policies, intellectual property protection, non-tariff
barriers and import tariffs. In developing countries, pharmaceutical costs are the largest
health-related expenditures after staffing costs, comprising 40-60% of total health costs
(World Bank 1993). The cost of medicines incorporates several added costs prior to reaching
patients and includes the base prices (i.e. its price as sold from the manufacturer) as well as
all costs for transportation, storage, import tariffs and taxes, wholesale and retail mark-ups,
staff salaries, stock losses and procurement practices. These hidden costs can often more than
double the manufacturer's price (Perez-Casas, Herranz & Ford 2001). From the government's
standpoint, the purpose of tariffs can be divided into two categories;
as a revenue generating mechanisms or to protect the local pharmaceutical industry (Pindyck
& Rubinfeld 1998). From the point of view of the consumer, tariffs raise the domestic price
of the good, and hence lower the demand (Bollinger, 2002). Tariffs on medicines are
essentially a regressive form of taxation since a smaller proportion of the payers income is
affected by the tariff as income rises. This regressive tax on medicines targets the poor and
the sick. Import Tariffs An import tariff is a customs duty imposed by importing countries on
the value of goods brought in from foreign countries. They are usually levied either on an ad
valorem basis (percentage of value) or on a specific basis (e.g. $7 per 100 kgs.). Tariffs on
finished products give a price advantage to similar locally-produced goods and raise revenues
for the government (World Trade Organization online glossary). Tariffs on imported inputs
(e.g. active pharmaceutical ingredients) also raise revenue, but can adversely affect local
production costs.

Woodward (2001)

Woodwards paper considers how import tariffs and other trade barriers determine the price
of essential health sector inputs, both pharmaceutical and non-pharmaceutical, necessary for
prevention and treatment objectives. Generally, tariffs increase the prices of imported inputs
directly, by levying a tax on them, while non-tariff barriers create an artificial scarcity,
driving up prices in the local market. At the same time however, there are costs associated
Pharmaceutical Tariffs Olcay & Laing 14 May 2005 with the lowering of trade barriers. In
particular, the reduced protection worsens the financial position of domestic producers,
potentially causing loss of employment and income and
lower receipts from tariffs reduce overall government revenues. This said, Woodward argues
that these assumptions may not necessarily apply to pharmaceuticals. In particular, he states,
that border prices vary considerably between countries as a result of price discrimination by
suppliers and due to the presence of a domestic pharmaceutical industry. On top of this, there
may also be price discrimination within countries, e.g. to charge lower prices to the public
and/or non-profit sectors than for the private-for-profit sector. Woodward suggests that this
may be because prices are held down by the availability of low cost domestic production and
that tariffs help to maintain the viability of domestic pharmaceutical producers. The author
concludes that: 1) reducing tariffs on pharmaceuticals and the active ingredients required for
their production appears more likely to increase final pharmaceutical prices than to reduce
them overall by undermining low-cost domestic producers; 2) both for pharmaceuticals and
ITNs, other domestic and international factors affecting
prices are likely to be of substantially greater significance than tariffs as price determinants;
3) even where tariff reduction has the potential to reduce prices, the associated revenue loss
may have a significant impact on public sector recurrent health spending, at least in some
Sub-Saharan countries, so that the trade-off between price reduction (and the associated
effect on utilisation) and government revenue losses needs to be taken into account
(Woodward, 2001). Woodwards conclusions are surprising and call for a better
understanding of the relative importance of tariffs in government revenue. Moreover, the data
cannot account for countries which do not fit into the same pattern, which may have a
thriving domestic industry yet low tariffs like South Africa or countries with no industry.
..FN........ Adlung R, Carzaniga A. Health services under the General Agreement on Trade in
Services.
World Health Organization 2001, 79(4):352-364........

The European Commission 2003:

Between 2001 and 2003, The European Commission carried out a study to assess the duties
and taxes applied to pharmaceutical products used in the treatment of the major
communicable is eases to lend support to Programme for Action: Accelerated action on
HIV/AIDS, malaria and TB in the context of poverty reduction. The study covered 57
countries and looked at the range, the average and the distribution of the different rates of
custom duties, VAT and other duties (European Commission, 2003). The study
distinguished between duties and taxes on four categories of product: compounds
(molecules), bulk manufactured medicaments, retail manufactured medicaments and
vaccines. The study also looked at the value of EU exports to developing countries as a basis
for estimating the value of duties and taxes collected. Within this framework, the study
provided a review of country trends. The findings highlighted the large disparities in custom
duties between countries but also that in general, few developing countries applied peak
tariffs and that the least developed countries had the lowest rates of duties and taxes (See
Table 4). The findings also indicated that customs duties represent one third of the total taxes
and duties applied to pharmaceutical products and that applied total duties and taxes on
compounds were usually higher than on manufactured medicaments. Finally, the study
concluded that, "taxes and duties collected on pharmaceutical products represent 17% of the
public health expenditure of least developed countries and 9% on average for the countries
covered by the study". (European Commission, 2003). The overall picture led them to
suggest that large disparities between countries point to a lack of direct correlation between
the volume of imports and rates of customs duties.

Introduction
The current Pharmaceutical Industry is well organized, systematic and compliant to
international regulatory standards for manufacturing of Chemical and Biological drugs for
human and veterinary consumption as well as medical devices, traditional herbal products
and cosmetics. Stringent GMPs are being followed for blood and its derivative as well as
controlled manufacturing for Traditional Herbal Medicines, Cosmetics, Food and Dietary
products which was otherwise differently a century before. Each regulatory system had faced
certain circumstances which led to current well-defined controlled regulatory framework.
This has resulted into systematic manufacturing and marketing of safe, efficacious and
qualitative drugs. With the growth of industry, the legislations from each region have become
more and more complex and created a need for regulatory professionals. To understand the
chronological development of the modern era of pharmaceutical industry and regulatory
framework, we will glance through the historical evolution of regulations in USA, Europe
and India.
.
Objectives

After reading this paper, you should be able to understand


- How and why the pharmaceutical industry and drug regulations have developed in USA
- Major Regulations of USA
- EU and its regulatory framework
- Content of The Rules Governing Medicinal Products in the European Union
- Pharmaceutical Legislations of EU
- EMEA and its Committees
- Types of Marketing Authorization Procedure in EU
- Indian Pharmaceutical Industry & Drug Regulations development in different Era
- Major Rules and Act of India
- Drug Regulatory Affairs and Global, Regional and National Regulatory Network
- Roles of Regulatory Affairs Professional in Health Authorities as well as Pharmaceutical
Industry
- Regulatory Affairs Network in Pharmaceutical Industry

Historical Overview of Pharmaceutical Industry

During 1950s, multiple tragedies i.e. sulfanilamide elixir, vaccine tragedy and thalidomide
tragedy have resulted in substantial increase of legislations for drug products quality, safety
and efficacy. This has also resulted into stricter norms for Marketing Authorization (MA) and
Good Manufacturing Practices (GMPs). Let us see what happened in USA, Europe and India.
United States of America (USA)
During the early Eighteenth century, chemical manufacturing factories had started
establishing and the first large scale manufacturing of glycerine started during 1818-1840.
However, with regard to medicines, it was being compounded by Pharmacists and Doctors at
Pharmacy laboratories. Crude drugs i.e. opium were extracted from The Biologics Control
Act of 1902 was the result of the vaccine tragedy. This legislation mandated manufacturing
and distribution licensing of biological products i.e. serum, vaccine, toxin, viruses as well as
defined labeling in terms of manufacturers name, address, license number, identification of
product and expiry date (Figure 2).
Proceeding further from Import Drugs Act of 1848 to The Biologics Control Act of 1902,
federal government took steps for controlling adulteration or misbranding of foods, drugs,
medicines, liquors. This law prohibited interstate transportation of adulterated food and
drugs. With this law toxic colors and preservatives like borax, sulphuric acid, formaldehyde,
copper and sulphate were banned for usage in food and drugs. The Food and Drugs Act of
1906 is best known as Wiley Act, named by Dr. Harvey W. Wiley. This law made mandatory
labelling of ingredients and its content for drugs i.e. alcohol, cocaine, heroin, morphine,
opium. This was the first wide ranging, national legislation on food and medicines safety
(Figure 3).
The Federal Food and Drugs Act 1906 was starting point for eventual creation of Food and
Drug Administration (FDA). Originally The Bureau of Chemistry was used to regulate food
safety, however in 1927, it was reorganized into the Bureau of Chemistry and Soils and Food,
Drug and Insecticide Administration. In 1930, the current Food and Drug Administration
(FDA) came into effect after shortening of earlier organization. Since the root of FDA was
born in 1906, FDA still celebrates 1906 as its establishment year.
From the above act, regulatory control on food and drug has increased drastically.
However Sulfanilamide Elixir tragedy raised concern about the safety of drug products. In
1938, more than 100 people were died due to diethylene glycol (highly toxic solvent) utilised
for mixing Sulfanilamide drug. Consequently, the law was enacted as Food, Drug and
Cosmetic Act of 1938 to oversee safety of medicine. With this law, pre-marketing approval
of all new drugs was made ingredients derived from bovine materials i.e. lactose, magnesium
stearate, gelatin.
Free availability of information: Positive and negative news/ information about medicine
is available almost to everyone due to wide spread use of media and World Wide Web
(internet) network. To ensure publics confidence in healthcare system, regulations pertaining
to quality, safety, efficacy and clear instructions for use came into effect.
Products and technology innovation: Development of new products such as biologics,
blood and blood related products, and in-vitro diagnostics needed new legislations. It has led
to the development of concertation procedure in 1987, where member states agreed to
assess common Marketing Authorization Application (MAA).
Demands for products safety: Regulatory authority demands safety data to support
Marketing Authorization (MA) as well as monitoring of safety data throughout the products
post authorization cycle. New legislations have started coming in place due to public demand
of improved quality of life as well as improved survival rate and longevity.
Changes in market structure: Healthcare regulations were required due to creation of single
EU market by removing trade barrier. In this scenario, regulatory framework was varied from
one country to another. Hence common regulatory framework was required. Since the market
was open, the quality concern for imported products was arise and led to the development of
new regulations.

European commission (EC) regulatory framework

First Legislation 65/65/EEC: In Europe the first pharmaceutical directive published by


European Economic Commission was 65/65/ EEC. The main goals of this legislation were
protection of human health and free movement of products among member states (Figure 7).
The current EU legal framework is available as series of volume published officially by
European Committees as The Rules Governing Medicinal Products in the European Union.
It gives complete clarity about regulatory framework of Europe Commission [2].
It is divided as below:
Pharmaceutical legislation: Currently, the EU legislation on medicinal products consists
basically of Directives, Regulations, Decisions and Recommendations.
Directives must be transferred into national law by the member countries prior to
becoming effectives.
Regulations apply directly in all member states.
India: The drug industry in India was at very primitive stage till 20th Century. Most of the
drugs were imported from foreign countries. Post First World War, the demand for drugs had
increased tremendously and that led to the cheap & substandard drugs into the market, as like
in USA post Mexican American war .

The year of 1900-1960:


a) To control cheap drugs in market, Government passed the Poisons Act 1919. This Act
regulates possession of substance or sale of substances as specified as poison. It also
specifies the safe custody of the poisons, labeling and packaging of poisons, maximum
quantity to be sold and inspection as well as examination of the poison sold by vendor
during the year.
The Poisons Act was followed by The Dangerous Drugs Act 1930. This act regulates the
opium plant cultivation, manufacture and possession of opium, its import, export, tranship
and sell of opium.
The Narcotics and Psychotropic Substances Act was passed in 1985 which revoked the
Dangerous Drugs Act 1930 and Opium Act, 1878. Following acts & rules were passed during
this era:
Drugs and Cosmetics Act, 1940: Regulate the import, manufacture, distribute and sale of
drugs. This act covers allopathic, homeopathic, Unani and Sidha drugs.
Drugs and Cosmetics Rules, 1945: The rules under the Drugs and Cosmetics Act regulate
only manufacture of Ayurvedic drugs for sale, and not for consumption, use or
possession.
Pharmacy Act, 1948: This law was amended lastly in 1986 and it regulates the pharmacy
profession of India.
Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955: This rules
control the drug advertisement in India.

Drugs Prices Control Order, 1955 (DPCO) (under the essential commodities Act):

DPCO was further amended in 1995. Under this rule, government may review and fix
maximum sale price for bulk drugs as well as formulation.

In the year of 960-1970:

The market share was dominated by multinational companies and very few indian
manufacturers were present. The Indian Pharmaceutical industry was in an early stage of It
mandates registration of Clinical Research Organization (CRO) for conducting Clinical
Trials (CT). Schedule Y1 suggests requirements and guidelines for registration of Clinical
Research Organizations. Pharmacovigilance Programme of India (PvPI): The Central
Drugs Standard Control Organization (CDSCO) has launched Pharmacovigilance
programme to assure drugs safety to Indian patients. This will help monitoring adverse
drug reactions to Indian patients, as well as monitoring of benefit-risk ratio.
Guidance documents: CDSCO has issued guidance for Industry for Fixed Dose
Combinations (FDCs) registration as well as Guidance for preparation of Common
Technical Document for Import/manufacture and Marketing Approval of New drugs for
Human Use (New Drug Application-NDA).
With this CDSCO has implemented system for preliminary scrutiny at the time of
application receipt for marketing approval of Fixed Dose Combinations (FDCs).
Drug Regulatory Affairs.

Introduction

As we have seen that from previous part of this chapter, legislations for marketing
authorization as well as standards and quality of drugs are becoming more and more
demanding and complex. Unlike earlier days, drugs are being developed for specific market
keeping regulations of that country or region in mind. Without fulfilling requirements of law
of land, it is practically impossible to have drug products in market. It is not stopping till
initial marketing approval of the product but it goes beyond that and demands management of
approval by submitting post marketing surveillance data, variation application and renewal
during the approval life cycle of product.
Due to rapid increase in laws, regulations and guidelines for reporting safety, efficacy and
quality of new medicinal products, necessity for expert regulatory professional arises
tremendously. None of the drug manufacturing / marketing units are able to launch drug in
market until and unless respective health authority (national / international) give green signal
in writing.
Almost two decades before, drug regulatory affairs was least known needed by
pharmaceutical industryhttp://trade.ec.europa.eu/doclib/docs/2016/june/tradoc_154665.pdf
It was in very nascent stage where registration executives were working under export
department. However, the situation has changed drastically where fully fledged Global
Regulatory Affairs department become mandatory to define drug development, approval
and marketing strategy. Hence, the scope of Drug regulatory affairs has become vast and
experts are needed in health authorities and pharmaceutical industry at various levels and
departments..............FN..........
1.http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/default.htm
2. http://www.ema.europa.eu
3. http://cdsco.nic.in/

The bee is how to take honey from the flower like that the tax authority should be collect tax
from the people. This is applicable to indirect tax because the customer does not know about
indirect tax. The reason is no one do not mention the rate of tax the related materials or
baggage etc., as per as my research paper research on medicine. Medicine is need for strong
of human life. So the benefit goes to all the people no one dont affect under the tax. The
Indian constitution to give guarantee for human health under articles 14 and 21 not only that
it is protect the peoples. Many countries treaties and declarations to give privileges to
pharmaceutical sector and it is established by the WTO and other organization. if we say
about WTO this organization is help of import and export activities this objective are
commonly accepted to all the coutries.this paper give wider explanation about under chapter
IV. Indirect tax to help of the country revenue. It is to be first choice for generating revenue
for a number of years. The government need for cash strong still. Whether the need is to
finance targeted stimulation programs for economy. As far as the global trade continuous to
grow but still faces trade restrictive measures in many regions of the world. As far as indirect
tax the Indian custom and excise is important one. The Indian custom act 1962 is explained
import and export goods and other rules and regulations. Duty levied on imports goods under
the act.CBCE (central board of customs and excise) control over the import and export
activities. If we say this is protect the domestic product of the import country. The board is
levied some duties like safeguard duty, antidumping duty, countervailing duty etc., it is help
to the domestic manufacturer. When the medicine import from another country the board
gives some exception under this act even though some medicine rate of tax is should be
increase in India compare with other countries. Goods imported through the land, sea, air.
In Many Countries The Tax As May Be Linked To Spending On Health And Welfare, And
they may become more problems increasing above.. There are still attempt to increasing the
tax burden on financial transactions, although there is no common global approach to active
this like eraq, Malaysia, Mexico, Malawi. As far the medicine so many acts are protect those
things like drug and cosmetic act 1940, Drugs Prices Control Order, 1955 (DPCO),
Dangerous Drugs Act 1930 and Opium Act, 1878, The Federal Food and Drugs Act 1906,
Pharmacy Act, 1948 etc.,

in1999Trends in international trade :

The world trade organization is one of the main role of the import and exports. International
trade is enveloping our economic level. here the medicine is one of the main of research in
1999 the sector level was defaulting the power and low level countries .whether it is the
manufacturing of active ingredients in bulk from basic chemicals, the preparation of finished
new medical entities, or the repackaging of imported generic ingredients to make finished
branded or unbranded generic products......
http://apps.who.int/medicinedocs/pdf/s6160e/s6160e.pdf........ Elsewhere, 97 countries have a
domestic medicines industry based on reproducer firms, manufacturing branded or
commodity generics. While the majority (84) of these manufacture finished products from
imported ingredients, 13 countries (including Brazil, Egypt, Norway, Turkey and Indonesia)
are considered to have industries which make both active ingredients and finished products.
Trade is dominated by imports and exports among high-income countries. Industrialized
countries are both the biggest individual exporters and the biggest importers of medicines.
The biggest 10 exporting countries accounted for 80% of world exports, and the biggest 10
importers accounted for over 60% of all imports in 1999. This concentration grew between
1980 and 1999, with low- and middle-income countries losing their combined share of both
exports and imports. However, several individual low-income countries, including India,
Pakistan and Indonesia, expanded their export share during this period. Low-income
countries manufacturing medicines produce predominantly for the home market. Many
countries both import and export medicines. The USA and Japan, the worlds two biggest
producers, were also the biggest net importers in 1999.
WHO recommends that medicines on a countrys essential medicines list should not be
subject to tariffs. However, in the 10 developing countries with the highest tariffs on
imported medicines, the average tariff adds almost 23% to the price of active ingredients and
over 12% to the price of finished medicaments. International trade in pharmaceuticals is
dominated by the high-income industrialized countries. In 1999, they accounted for 93% of
global exports and 80% of global imports. WHO recommends that medicines on a countrys
essential medicines list (EML) should not be subject to tariffs,1 and many countries comply
with this. While a source of revenue for governments, tariffs are also a barrier to trade.
Governments may also use tariffs to protect a domestically-owned manufacturer against
foreign competition. Whatever their purpose, tariffs raise the retail price of imported
medicines and are therefore a potential barrier to access. Other aspects of fiscal policy, such
as corporate taxation, can also affect the price to consumers, thus reinforcing the need for a
risk-pooling approach to medicines financing as part of an overall health system
strategy......... World health report 2000: health systems measuring performance. Geneva,
World Health Organization, 2000...............

Indian pharmaceutical sector under International trade:


The Indian pharmaceutical sector have two main concept. The first one the active
pharmaceutical ingredient or bulk drugs the second one is formulation segments. Bulk drug is
production increased by nearly 20% annually. Increase at an average rate of 15% per year.
The associated chamber of commerce and industry in India forecasted that the Indian
pharmaceutical industry will amount for about 30 % of the increasing generic medicine. The
pharmaceutical sector has seen policy intervention across the countries. The Indian
pharmaceutical industry the 1950s had titled technological capability to manufacture modern
drug locally.
Indian pharmaceutical industry consisting the 20000 registered units is one of the most new
organised in India economy. India has no reached a stage in pharmaceutical protection where
strong ipr would induce greater innovation by social firm. The competition commission of
India, the Indian pharmaceutical industry demand for bulk drugs. chemicals
,tablets,capsules,orals etc.,

China trend

When we compare with china for imports in the pharmaceuticals sector has the first of
exposing Indias production to externalities such as developing in India which can disturb
imports. The impact on import under china increased imports from china on India domestic
industry. It is reasonable assume that the strategic discriminatory pricing policy followed by
china. 8 10 pharmaceutical products from china face anti dumping duty in India
Technical Barriers to Trade (TBT): For medical devices and pharmaceuticals, China's
regulatory system should be aligned with international standards on issues such as clinical
trials and registration requirements. Also, the registration process for new cosmetics
ingredients should be improved and limited to higher risk ingredients. Concerning labelling
of cosmetics by using stickers (so-called "overstickering"), it is positive that China suspended
a measure aimed at prohibiting over stickering. The Commission addresses these issues
through bilateral trade dialogues and sector-specific technical dialogues.....................
http://trade.ec.europa.eu/doclib/docs/2016/june/tradoc_154665.pdf..................