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Import of Raw Materials 4 Pharmacy Products

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Introduction To Indian Pharmacompanies The pharmaceutical industry of India has matured over the years into a major producer of bulk drugs, rated among the top five in the world. The industry is largely concentrated in the production of ‘generics’ on account of the Process Patent Law introduced in the seventies (repealed under the recent TRIPS Agreement). India has since been able to establish technological capability for manufacture and supplying of generic drugs. This ‘generics capability’ of India has attracted worldwide attention.

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A noticeable surge in mergers and acquisitions with either a foreign company seeking a stake in an Indian counterpart or vice versa reflects the attractiveness of what has been called as the ‘platform of capabilities’. Indian companies seek to expand and consolidate their platform of capabilities in their endeavor to either develop indigenous branded generics or to acquire established branded generics. Today the Indian pharmaceutical industry has become a prominent provider of healthcare. It meets 95% of the country’s medical needs and constitutes about 1.

% of the world market in value terms and 8% in volume terms represented by 250 large pharmaceutical manufacturers (5 of these are in the public sector) and about 8000 small scale units. The generics pharmaceuticals sector in India have come of age, their future sustainable growth depends on ensuring competitive markets and the Competition Commission is sensitive to the differing perspectives that are inevitable to an industry so critical to life itself. Brief sketch of pharmaceuticals industry The Indian Pharmaceutical Industry is among top five producers of bulk drugs in the world.

Pharmaceuticals market can be roughly classified into Bulk drugs (20% of the market) registering growth rates of 20% and formulations (80% of the market) with an annual growth rate of 15%. There are about 8174 bulk drug manufacturing units and 2389 formulations units spread across the country. Pharmaceutical Companies Operating in India is a pool representing about 250 large Pharmaceuticals manufacturers and suppliers and about 8000 Small Scale Pharmaceutical & Drug Units including 5 Central Public Sector Units. At the time of independence, the bulk drug industry in India as in the infancy stage. Most of the bulk drugs and formulations were imported. Since then, the Indian pharmaceuticals industry has evolved through the opportunities arising within the regulated environment. The Indian Patents Act (1970) and establishment of large public sector companies for the manufacture of bulk drugs enabled the development of the pharmaceuticals industry in India. The Indian pharmaceutical industry from being a pure reverse engineering industry focused on the domestic market, the industry is becoming research driven, export oriented and globally becoming competitive.

The industry is dependent on its presence in the therapeutic segment and new categories, viz. cardiovascular, central nervous system and anti diabetic are expanding at double digit growth rates. The generic drug companies in India have broad technological and diversified market capabilities. As more and more patents expire, the generic portion of the pharmaceutical market is expected to continue to have increased sales. Indian companies are attempting to tap the generic drug markets of the developed countries.

The technological capability for manufacturing and supplying generic drugs of these companies make them major players in the international generics market. With the WTO commitment in Jan 1, 2005, to recognize foreign product patents outsourcing in the fields of R&D, contract manufacturing and co-marketing alliances have been identified by industry federations as an opportunity for Indian companies. India has the best chemistry skills and low cost advantages in research and manufacturing and skilled manpower, which will attract foreign investors, apart from encouraging basic research and drug discovery.

Branded Competition v/s Generic Competition It is interesting to observe the responses of a matured generics player to competition, where large numbers of patents are expected to expire in a few years time. Few cases reported by media and newspapers, given below, provide glimpses of how Indian companies have taken legal measures to refute claims of multinational drug majors for extension of their patents. a) A case that attracted a lot of attention in India is that of the Swiss drug company Novartis. Novartis had challenged Section 3(d) of the Indian Patents Act claiming immunity for their drug Gleevic, a major drug for leukemia on the leas that the new Gleevic was a major improvement over a older version whose patent was over. This was disputed by Indian companies such as Natco Pharmaceuticals. The plea of Novartis was rejected consequently enabling manufacture by Indian generic companies. Cost estimates of the new generic drug place it at one tenth the price of Gleevic. b). In a similar case the Delhi Court rejected the petition of Bayer Healthcare, a German drug major from preventing the Drug Controller General of India giving marketing approval to Indian company Cipla for the generic version of the cancer drug Nexavar.

The ruling however had a caveat namely, that if the Indian drug company is found guilty of patent infringement damages will have to be compensated by payment to Bayers. c). Cipla in another case won the right to manufacture and market the generic version of the anti-cancer drug Tarceva originally patented by the Swiss pharma company Hoffman La Roche both in Delhi Court and the Supreme Court. d). Recently, Aurobindo Pharma an Indian drug pharma received USFDA approval for Risperidone Oral Solution a drug used in the treatment of mental and emotional problems.

Indian companies are becoming increasingly active in the European Commission investigation into the case of ‘patent pooling’ a commonly used tactics for prolonging the life of a patent has attracted a lot of attention in India. EU is probing into the anti-trust violations indulged by Lupin, Matrix Laboratories and Unichem Laboratories for ‘knowingly delaying’ the generic launch of a cardiovascular drug, Perinaopril by teaming with the innovator of the drug, Laboratories Servier. History of Regulation in Pharmaceuticals In this section we shall briefly outline the regulatory framework.

The regulatory framework operates at two levels: i) licensing and ii) pricing. Licensing entails the need for manufacturers to get approval from Drug Regulatory Commissions at state-level. The Drugs and Cosmetics Act, 1940, governs the import, manufacture, distribution and sale of drugs, in India. The Drug Controller General of India (DCGI), an authority established under the Drugs and Cosmetics Act, 1940, oversees the conduct of clinical trials and is also responsible for the approval and registration of drugs, and issues manufacturing and marketing licenses for the same.

Essential drugs pricing is fixed by the Central Government. On a regular basis the list of drugs whose prices are controlled and the methodology of fixing prices is issued, referred to as the Drug Price Control Order (DPCO). In the last few years only a few essential drug prices are regulated and the implementing authority as of now is the National Pharmaceutical Pricing Authority. The Indian Patents Act (IPA), and the Drug Prices Control Order (DPCO) were both passed in 1970. Under the IPA, substances used in foods and pharmaceuticals could not be granted product patents.

Only process patents were allowed for a period of five years from the date of the grant of patent, or seven years from the date of filing for patent, whichever was earlier. The introduction of the IPA provided a major thrust to growth of the Indian generics pharmaceuticals industry; and Indian companies, who through the process of reverse engineering and synthesis, began to produce bulk drugs and formulations at lower costs. The DPCO is an order issued by the Government, under Section 3 of the Essential Commodities Act, l955, empowering it to fix and regulate the prices of essential bulk drugs and their formulations.

The order incorporates a list of bulk drugs whose prices are to be controlled, the procedure for fixation and revision of prices, the procedure for implementation, the procedure for recovery of dues, the penalties for contravention, and various other guidelines and directions. The order is subject to the guidelines of Drug Policy and supposedly aims to ensure equitable distribution, increased supply, and cheap availability of bulk drugs and played a vital role in directing the pharmaceutical industry’s fortunes. The first DPCO was issued in 1970, revised in 1979, 1987 and 1995.

In its introductory form, DPCO was a direct control on the profitability of a pharmaceutical business, and only an indirect control on the prices of pharmaceuticals. It stipulated that a company’s pre-tax profit from its pharma business should not exceed 15 per cent of its pharma sales (net of excise duty and sales tax). In case profits exceeded this sum, the surplus was deposited with the Government. So, a pharma company had the freedom to decide the prices of its products. Product-wise margins were also flexible, so long as the overall margin did not exceed the stipulated norm.

Since individual product prices did not require approval from the Government, bureaucratic hurdles were low. DPCO (1970) effectively put a ceiling on prices of all mass-usage bulk drugs and their formulations. Its primary objective was to protect the interests of consumers, and ensure a restricted but reasonable return to producers. The order was a landmark regulation and has had several implications in shaping the Indian pharmaceuticals industry. In 1974, the Government of India (GOI) appointed a committee under the chairmanship of Rajya Sabha MP, Mr.

Jaisukhlal Hathi, to inquire into the conditions prevailing in the sphere of pharmaceuticals in the country. DPCO 1979 was loosely based on the recommendations of the Hathi Committee. The revised DPCO stipulated ceiling prices for controlled categories of bulk drugs and their formulations. The retail prices of controlled formulations were decided by applying the concept of MAPE (Maximum Allowable Post- manufacturing Expenses). DPCO 1979 put 370 drugs under price control. These drugs were segregated into three categories, having different MAPEs.

The most important drugs, including life-saving drugs were put in Category I, which had the least MAPE. Through this DPCO, around 80 percent of the Indian pharma industry (in value terms) was brought under strict price control. However, 13 Transnational Corporations (TNCs) challenged the order and succeeded in obtaining a stay on the DPCO, 1979, from High Courts and ignored the prices fixed under this. Ultimately the Government of India had to appeal to the Supreme Court, which upheld the validity of its action and directed the Government to assess and recover the amounts.

In 1984, the Government constituted another expert committee to look into the issue of drug pricing known as the Kelkar Committee. The Committee recommended the exclusion of a number of drugs from the purview of price control. Various suggestions were made for determining the criteria for inclusion and exclusion. DPCO, 1987, was based on the Drug Policy of 1986, and the Kelkar Committee Report. In DPCO, 1987, the number of bulk drugs under price control was significantly reduced from 370 to 142.

In addition, the categories of control were reduced to two, and higher MAPE was provided for each category of controlled drugs (75 per cent and 100 percent respectively). However, around 75 per cent of the pharmaceutical industry was still under price control. In September 1994, the New Drug Policy was announced. The New Drug Policy liberalized the criteria for selecting bulk drugs, or formulations, for price control. In addition, industrial licensing was abolished for all bulk drugs. All hindrances to capacity expansions were removed, and it was expected that, as a result, supply would rise, resulting in higher competitive pressures.

Foreign investment up to 51 per cent was also permitted in the case of all bulk drugs, their intermediates and formulations. FDI above 51 per cent could also be considered on a case-to-case basis. Nevertheless, five bulk drugs; Vitamin B1, Vitamin B2, Folic Acid, Tetracycline and Oxy-tetracycline were reserved for the public sector till 1998. The latest Drug Price Control Order was passed in 1995. The basic structure of this DPCO is the same as that of the earlier orders, except that a uniform MAPE of 100 per cent was granted to all controlled formulations.

Nevertheless, the span of price control, under DPCO 1995, was liberalized considerably from 142 drugs to just 76. It was under the New Drug Policy, National Pharmaceutical Pricing Authority (NPPA) was appointed to implement and enforce the provisions of the Drugs (Prices Control) Order 1995 in accordance with the powers delegated to it. Thus, the objective of the Government was to decontrol in order to induce increased competition and to make essential drugs affordable to the weaker sections of society.

Competition in the domestic market: Generics and the healthcare system: How does the ‘generic capability’ of Indian companies emerging as major players in the world market affect competition in the domestic market? The domestic market is very competitive with a large number of players and is characterized by several market segments. There are pure generics; branded generics, formulations, with varying degrees of combinations and permutations among large players and small players.

Surprisingly despite the comparative advantage in generics the Indian market remains largely untapped with one estimate on penetration of modern medicine placing it as less than 30%. This applies to the healthcare segment. The basis for competition exists. While the objective of the government to decontrol in order to increase competition the concern of the Commission is on ensuring competition and on this aspect it is worthwhile to glimpse briefly at the dynamics of the Indian pharmaceutical sector and also the health care segment.

While the number of drugs decontrolled has increased, the maturing of the pharmaceutical industry can be seen in the wide range of drugs ranging from pure generics to branded generics enabling the consumer to exercise choice. Studies have shown that a generic controlled by DPCO required to be sold at an MRP of Rs. 7/- per strip can be marketed separately as a branded drug at Rs. 15/- per strip i. e. at double the price, often on account of variations in the chemical combinations of the branded generic as compared to the generic drug.

This suggests developing universal classification systems, but there are limitations to such universality. The choice of patients to either buy generics or branded drugs to some extent may be influenced by whether they seek to avail of the public health system or go to a private hospital and within the two systems there are again several options. Access to drugs and healthcare is an important dimension of ensuring competition between branded generics and generics. Similarly, information available in the public domain on common drugs can also have a contributing role towards competition.

While there is range of choice open to consumers, the exercise of choice is determined by several factors but the critical factor is on the availability of information. In brief, competition as always depends on ensuring smooth and free flow of information. Towards this end the suggestions are: (a) Strengthening the existing regulatory system especially for enabling more detailed and universal classification of drugs and chemicals between branded generic and generic (b) Strengthening the public information system where simple drugs are known to consumers (c) Strengthening the public procurement process of drugs by public health system.

The Indian pharmaceutical industry is at the crossroads: on the one hand, opportunities are emerging in the developed markets, while on the other, the domestic market is becoming increasingly challenging following the introduction of the product patent regime. In developed markets, the focus on reducing healthcare costs has been increasing, with the result that there is pressure on the authorities to allow early introduction of low-cost generic drugs. This in turn points to large opportunities for Indian drug manufacturers with approved facilities and sound knowledge of patent/regulatory issues.

Besides, the impending expiry of significant drug patents in the near term also offers opportunities for lower-cost Indian generic manufacturers in terms of greater market access. However, even as there are opportunities, the challenges are many: drawing up appropriate distribution strategies, selecting the right products, and anticipating competition, among others. Historically, in the domestic market, the option to reverse engineer new molecules and come up with alternative drugs meant that investments in product development were generally low while at the same time competition was intense, given the low entry barriers.

However, with the product patent regime having been introduced this calendar, domestic players, to augment their product baskets, would need to focus more on R&D and enter into alliances with innovator MNCs. Market Prospective for Bulk Drug/Raw materials For Indian Pharmaceutical industry Now-a-days the Indian pharmaceutical industry is growing tremendously, so as per the market requirement for the bulk drug, raw materials and the finished formulation is having rigorous market. Classification Of finished formulation:- 1. Solid Oral formulation (i. e.

Tablets, capsules, Dry powder for sachet, Mups ,etc) 2. Liquid oral formulation (i. e. Suspension, Emulsion, Syrups etc) 3. Semisolid Formulations ( i. e. Cream, Ointments, Lotion, etc) 4. Gaseous Formulation ( Aerosol, Medicated Spray ,etc ) Classification of Raw materials For pharmaceuticals:- 1. Active Pharmaceutical Ingredients (i. e. , Anti-malarial drugs, Anti hypertensive drug, Anticancer drugs, Analgesic, Anti pyretic drugs, sedatives and hypnotic drugs , etc) 2. Inactive Pharmaceutical Ingredients are categorized bellow Acidifying Agent| Alkalizing Agent| Antifoaming Agent|

Acetic Acid Citric Acid Monohydrate Fumaric Acid Hydrochloric Acid Malic Acid Nitric Acid Phosphoric Acid | Ammonia Solution, Strong Ammonium Carbonate Diethanolamine Potassium Hydroxide Sodium Bicarbonate Sodium Carbonate Sodium Hydroxide | Dimethicone Myristic Acid Palmitic Acid Simethicone | Antimicrobial Preservative| Antioxidant| Buffering Agent| Benzalkonium Chloride Benzoic Acid Butylparaben Cetylpyridinium Chloride Methylparaben | Ascorbic Acid Ascorbyl Palmitate Butylated Hydroxyanisole Hypophosphorous Acid Monothioglycerol | Acetic Acid Ammonium Phosphate Boric Acid Sodium Lactate |

Emulsifying and/or Solubilizing Agent| Flavors and Perfumes| Glidant and/or Anticaking Agent| Acacia Lecithin Poloxamer Hydrogenated Castor Oil Propylene Glycol Sodium Lauryl Sulfate Trolamine | Almond Oil Ethyl Acetate Maltol Menthol Monosodium Glutamate Peppermint Rose Oil | Calcium Silicate Magnesium Silicate Silicon Dioxide, Colloidal Talc | Sweetening Agent| Tablet Binder| Tablet and/or Capsule Diluent| Aspartame Dextrose Fructose Maltose Mannitol Saccharin Sucralose Sucrose Sugar| Acacia Cellulose Microcrystalline Methacrylate Ethylcellulose Glucose Guar Gum HPMCMaltodextrin

Starch| Calcium Phosphate, Cellulose, Microcrystalline Dextrin Fructose Lactose Maltitol Mannitol Starch Sucrose | Tablet Disintegrant| Tablet and/or Capsule Lubricant| Water Repelling Agent| Croscarmellose Sodium Crospovidone Polacrilin Potassium Sodium Starch Glycolate Starch, Pregelatinized| Magnesium Stearate Polyethylene Glycol Hydrogenated Castor Oil Sodium Stearyl Fumarate Talc | Cyclomethicone Dimethicone Simethicone | Rules and Regulation for Import and Exports Of Rawmaterials * Brief Background of Customs Law Customs duty in India is applicable on goods on imported in and exported from India.

We will see some basic concepts of the Act in this Chapter. A. Problems due to high customs duty – Heavy customs duty had started becoming counter-productive. Indigenous industries, protected from foreign competition, became self complacent. They neglected aspects of quality and productivity. The result is that ‘Made in India’ label has become a sign of poor quality product in international market. Productivity of Indian Industry in many cases is as low as 20 to 30% of comparable industries abroad. Indian exports are restricted in some countries due to our protectionist policies.

Smuggling, mafia and havala trades increased to unprecedented levels due to heavy customs duties and restrictions on imports. Government has realised these aspects. Restrictions on imports have been considerably reduced. Rupee has been made freely convertible on current account. Customs duties were lowered to 150% (basic plus auxiliary) in 1991. It was brought to 110% in March 1992, 85% in March 93, 65% in March 94, 50% in March 95 and 42% in March, 1997. [40% basic plus 2% special]. The peak rate on non-agricultural goods was brought down to 38. 5% in March, 2000 (35% basic plus 10% surcharge).

It was brought down to 35% on 1. 3. 2001, 30% on 1-3-2002, 25% w. e. f. 1-3-2003 and 15% w. e. f. 1-3-2005. It is reduced to 12. 5% w. e. f. 1-3-2006 and to 10%. B. CVD / SAD in addition to basic customs duty – In addition to basic customs duty, Special Additional Duty of 4% (SAD) and Countervailing duty (CVD) equal to excise duty (which is usually 16%) is also payable. C. Education Cess – In addition, education cess of 2% and secondary and higher education cess of 1% is payable. D. Calculations of customs duty – Calculation of duty payable is as follows | |  | Duty %| Amount| Total Duty| A)| Assessable Value Rs| | 10,000| | (B)| Basic Customs Duty| 10| 1,000. 00| 1,000. 00| (C)| Sub-Total for calculating CVD ‘(A+B)’| | 11,000. 00| | | (D)| CVD  ‘C’ x excise duty rate| 8| 880. 00| 880. 00|  (E)| Education cess of excise – 2% of ‘D’| 2| 17. 60| 17. 60|  (F)| SAH Education cess of excise – 1% of ‘D’| 1| 8. 80| 8. 80|  (G)| Sub-total for edu cess on customs ‘B+D+E+F’| | 1,906. 40| | | (H)| Edu Cess of Customs – 2% of ‘G’| 2| 38. 13| 38. 13|  (I)| SAH Education Cess of Customs – 1% of ‘G’| 1| 19. 06| 19. 06|  (J)| Sub-total for Spl CVD ‘C+D+E+F+H+I’| | 11,963. 59| | | K)| Special CVD u/s 3(5) – 4% of ‘J’| 4| 478. 54| 478. 54|  (L)| Total Duty| | | 2,442. 13| | (M)| Total duty rounded to| Rs| 2,442. 00| * Scope and coverage of Customs Law Section 12 of Customs Act provides levy of duty on Imports as well as exports. The rate of duty is as prescribed in Customs Tariff Act, 1975, read with relevant exemption notifications. Import duty is levied on almost all items, while export duty is levied only on a few limited products, where Indian goods are in commanding position. Raising revenue for Central Government is the main but not the only purpose of Customs Act.

Customs Act is used to (a) regulate imports and exports (b) protect Indian industry from dumping (c) collect revenue of customs duty. In addition, provisions of Customs Act are used for other Acts like Foreign Trade (Development and Regulation) Act, Foreign Exchange Management Act (FEMA) etc. Customs Law is covered under various Acts, rules, regulations and notifications, as follows: A. Customs Act, 1962 – This is the main Act, which provides for levy and collection of duty, import/export procedures, prohibitions on importation and exportation of goods, penalties, offences etc. B.

Customs Tariff Act, 1975 – The Act contains two schedules – Schedule 1 gives classification and rate of duties for imports, while schedule 2 gives classification and rates of duties for exports. In addition, the CTA (Customs Tariff Act) makes provisions for duties like additional duty (CVD), preferential duty, anti-dumping duty, protective duties etc. C. Rules under Customs Act – Under section 156 of Customs Act, 1962, Central Government has been empowered to make rules, consistent with provisions of the Act, to carry out the purposes of the Act. Various rules have been framed under these powers.

Major among these are : Customs Valuation Rules, 1988 : for valuation of imported goods for calculating duty payable; Customs and Central Excise Duties Drawback Rules, 1995 : mode of calculating rates of duty drawback on exports; Baggage Rules, 1998 : rules and allowances for bringing in baggage from abroad by Indians and tourists; Customs (Import of goods at concessional rate of duty for manufacture of excisable goods) Rules, 1996 : provides procedure to be followed when goods are imported for export purposes; Other rules are : Rules regarding notified goods, specified goods, etermination of additional duty for dumping, determination of origin of goods etc. D. Regulations under Customs Act – Under section 157 of Customs Act, 1962, Board (CBE;C) has been empowered to make regulations, consistent with provisions of the Act, to carry out the purposes of the Act. Various regulations have been framed under these powers. Major among these are: Project Import Regulations, 1986: procedures for project imports; Customs House Agents Licensing Regulations, 1984: Regulation of CHA.

Other regulations regarding transshipment of goods, Import and Export report, Import and Export manifest, manufacture in warehouse, shipping bill and bill of export (form) etc. have been made. In Sukhdev Singh v. Bhagatram Sardar Singh (1975) 1 SCC 421 = AIR 1975 SC 1331 (SC Constitution Bench), it was held that regulations framed under statutory provisions would have the force of law. E. Notifications under Customs Act – Various sections authorise Central Government to issue notifications. The main are: section 25(1) to grant partial or full exemption from duty and section 11 to prohibit import or export of goods.

Others are: – specifying notified goods (section 11B), specifying specified goods (section 11-I) etc. F. Board Circulars– CBE;C is empowered u/s 151A of customs Act to issue, for purpose of uniformity in classification of goods or with respect to the levy of duty thereon, issue such instructions and directions to officers of customs and they are required to observe and follow such orders, instructions and directions of Board. CBE;C issues circulars giving various instructions / prescribing various procedures etc. Normally, these instructions should be followed. G. Customs Manual, 2001 –

Customs Manual, 2001 was released by CBE;C in September, 2001. The Manual gives an overview of Customs Law and Procedures. It is not stated that the Customs Manual is issued under any provision of Customs Act or Rules. However, normally, instructions in Customs Manual, 2001 should be followed. H. Public Notices – Often, Commissioners of Customs issue Public Notices. Often they just forward the Board circulars, but sometimes, public notices for local requirements are also issued. I. Customs and Central Excise – There are many common links between Customs and Central Excise. . Both are Central Acts and derive power of levy from list I – Union List – of the Seventh Schedule to Constitution. ii. Both are under administrative control of one Board (Central Board of Excise and Customs) under Ministry of Finance. iii. Organizational hierarchy is same from top upto Assistant Commissioner level. Transfers from customs to excise and vice versa are not uncommon. iv. Chief Commissioner in charge of each Zone is same for excise and customs at many places. v. In the interior areas, Excise officers also work as customs officers. i. Classification Tariffs of both acts are based on HSN and principles of classification are identical. vii. Principles of deciding ‘Assessable Value’ have some similarities i. e. both are principally based on ‘transaction value’. Concept of ‘related person’ appears in Customs as well as Excise valuation. viii. Provisions of refund, including principle of ‘unjust enrichment’ are similar. Provisions for interest for delayed payment are also identical. ix. Provisions of raising demand for short levy, non-levy or erroneous refund are similar.

Provisions in respect of recovery, mandatory penalty etc. are also similar. x. Provisions for granting exemptions from duty – partial or full – conditional or unconditional are identical. xi. Powers of search, confiscation etc. are quite similar in many respects. In fact, some of provisions of Customs Act have been made applicable to Central Excise with suitable modifications. xii. Provisions in respect of Settlement Commission and Authority for Advance Ruling are identical. xiii. Appeal provisions are identical. xiv. Appellate Tribunal (CESTAT) is same.

Hence, procedures of appeal to Tribunal are identical. * Nature of Customs Duty Entry 83 to List I – (Union List) of Seventh Schedule to Constitution reads ‘Duties of customs including export duties’. Thus, import and export duty is a Union subject and power to levy is derived from Constitution. Section 12 of Customs Act, often called charging section, provides that duties of customs shall be levied at such rates as may be specified under ‘The Customs Tariff Act, 1975′, or any other law for the time being in force, on goods imported into, or exported from, India.

Section 3 of Customs Tariff Act has also been held as ‘charging section’ (for levy of CVD – additional customs duty) – Jain Brothers v. UOI 1999(4) SCALE 207 = AIR 1999 SC 2550 = JT 1999(5) SC 100 = 112 ELT 5 = 1999 AIR SCW 2718 (SC 3 member bench). A. Taxable Event for Import duty – Goods become liable to import duty or export duty when there is ‘import into, or export from India’. As per section 2(28), ‘export’ with its grammatical variations and cognate expressions, means taking out of India to a place outside India.

As per section 2(23), ‘import’ with its grammatical variations and cognate expressions, means bringing into India from a place outside India. In Gramophone Company of India v. Birendra Bahadur Pandey – AIR 1984 SC 667, it was held that ‘import’ included goods imported for transit across to Nepal. Section 2(27) of Customs Act defines ‘India’ as inclusive of territorial waters. Hence, it was thought that ‘import’ is complete as soon as goods enter territorial water. Similarly, export is complete only when goods cross territorial waters. There were conflicting judgments of High Courts.

Finally, in Kiran Spinning Mills v. CC 1999(113) ELT 753 = 2000 AIR SCW 2090 (SC 3 member bench), it has been held that import is completed only when goods cross the customs barrier. The taxable event is the day of crossing of customs barrier and not on the date when goods landed in India or had entered territorial waters. In the case of goods which are in the warehouse the customs barrier would be crossed when they are sought to be taken out of the customs and brought to the mass of goods in the country. In case of warehoused goods, the goods continue to be in customs bond.

Hence, ‘import’ takes place only when goods are cleared from the warehouse – confirmed in UOI v. Apar P Ltd. 1999 AIR SCW 2676 = 112 ELT 3 = 1999(4) SCALE 313 = AIR 1999 SC 2515 (SC 3 member bench). – followed in Kiran Spinning Mills v. CC 1999(113) ELT 753 = 2000 AIR SCW 2090 (SC 3 member bench), where it was held that taxable event occurs when goods cross customs barrier and not when goods land in India or enter territorial waters. In CC v. HPCL 2000(121) ELT 109 (CEGAT), it was held that the ‘bulk liquid cargo’ would be considered to have crossed customs barrier only when they are pumped into shore tanks.

That being the taxable event, duty is levieable only on that quantity. – – The view has been accepted by department. It has been confirmed that duty will be payable on the basis of ‘shore tank receipt’ i. e. dip measurement in tanks on shore into which oil is pumped from tanker; and not on the basis of ulage survey report i. e. ulage quantity at the port of discharge on board the vessel, as determined by independent surveyors in presence of customs officers. – MFCA (DR) circular No. 96/2002-Cus dated 27-12-2002.

Though there is slight contradiction between the SC judgments, it can be said that ‘mixing up with mass of goods in the country’ after crossing customs barrier is the ‘taxable event’ for customs duty. This judgement is in harmony with other judgments and law as explained below – Date of filing bill of entry is relevant for deciding duty liability – As we will see later, rate of duty and tariff valuation as on date of presentation of bill of entry or date of entry inward of the vessel, whichever is later, is relevant for determining the customs duty payable.

Thus, rate of duty when ship enters the port is relevant and not the date when ship enters territorial waters. B. Taxable event in case of exports – Though Supreme Court judgement does not prescribe what is taxable even in case of export, it could be argued that in case of exports, export commences when goods cross customs barrier, but export is completed when it crosses territorial waters. Thus, ‘taxable event’ occurs only when goods cross territorial waters. In CC v.

Sun Exports – 1988(35) ELT 241 (SC) = 1988(1) SCALE 758 = 1988(17) ECR 6 (SC) = (1989) 1 CLA 138 (SC), it was held that export is complete once the goods leave Indian waters and property passes to purchasers. Even if goods return due to Engine trouble, duty drawback is payable. In B K Wadeyar v. Daulatram Rameshwarlal AIR 1961 SC 311 = 11 STC 757 (SC), it was held that export is complete when ship leaves territorial waters of India. Overwhelming view is that export is complete only when goods cross territorial waters of India. C. Territorial Waters of India –

Territorial waters means that portion of sea which is adjacent to the shores of a country. On 22nd March, 1956, President of India had issued a proclamation that territorial waters of India shall extend upto 6 nautical miles from the base line. This was extended to 12 nautical miles w. e. f. 30th Sept. , 1967. Later, ‘Territorial Waters, Continental Shelf, Exclusive Economic Zone and other Maritime Zone Act, 1976′ was passed. Section 3 of the said Act specify that territorial water extend upto 12 nautical miles from the base line on the coast of India and include any bay, gulf, harbour, creek or tidal river. 1 nautical mile = 1. 1515 miles = 1. 853 Kms). Sovereignty of India extends to the territorial waters and to the seabed and subsoil underlying and the air space over the waters. D. International Convention – United Nations Convention of the Law of the Sea dated 7th October, 1982 has been signed by most of the countries. This convention uses the words ‘territorial sea’, which is analogous to the term ‘territorial waters’ used in Customs Law. As per article 2(1) of this convention, Sovereignty of a coastal state extends beyond its land territory upto `territorial sea’.

The sovereignty extends to airspace over the territorial sea as well as to sea bed. Vide article 3 of the Convention, territorial sea extends upto 12 nautical miles from normal base-line. Base line is the low-water line along the coast. As per article 17 of the Convention, ships of all countries have right of innocent passage in the territorial sea. Article 21(1) specifically provides that coastal State may adopt laws and regulations in conformity with this convention. ‘Exclusive economic zone’ extends to 200 nautical miles from the base-line.

In this zone, the coastal State has exclusive rights to exploit it for economic purposes like constructing artificial islands (for oil exploration, power generation etc. ), fishing, mineral resources and scientific research. However, other countries have right of navigation and over-flight rights. Other countries can lay submarine cables and pipelines with consent of Indian Government. Such consent may be declined for protecting interest of India. Section 7 of Territorial Waters Act, 1976 has made similar provisions and thus, these provisions have been adopted in India too.

Beyond 200 nautical miles, the area is ‘High Seas’, where all countries have equal rights. These high seas are reserved for peaceful purposes. Any Country can use it for navigation, over-flight, laying submarine cables and pipes, fishing, construction of artificial islands permitted under international law and for scientific research. Extension of Customs Act, Service Tax and Excise Act to designated areas in EEZ – Customs Act has been extended to designated areas in Continental Shelf and Exclusive Economic Zone of India vide notification No. 11/87-Cus dated 14-1-1987 and 64/97-Cus dated 1-12-1997.

Similarly, Central Excise Law and Service Tax (Chapter V of Finance Act, 1994) have been extended to designated areas in Continental Shelf and Exclusive Economic Zone of India vide notification No 166/87-CE dated 11-6-1987 and 1/2002-ST dated 1-3-2002 respectively. Vide notification No. SO 189(E) dated 7-2-2002 issued by Ministry of External Affairs, Customs Act and Customs Tariff Act has been extended to whole of Exclusive Economic Zone (EEZ) and continental shelf of India for the purpose of (i) processing for extraction or production of mineral oils and (ii) Supply of any goods in connection with activities mentioned in clause (i). – – This has following implications – (a) Supplies from India in connection with production of mineral oils within EEZ and/or continental shelf of India shall not be treated as export and will not be entitled to export incentives. (b) Supplies of goods (for extraction or production of mineral oils) from other countries to units in this zone will be treated as import and duty will be levied accordingly. [Earlier, vide MF(DR) circular No. 17/2002-Cus dated 13-3-2002, it was stated that mineral oil produced within territorial waters are leviable to central excise duty.

This circular has been rescinded, probably because though Customs Act has been extended but Central Excise Act has not been extended]. In a further circular No. 638/29/2002-CX dated 22-5-2002, it has been clarified that Excise duty is not payable on LSD or HSD supplied to research vessels operating in territorial waters. However, if the vessels are engaged in exploration or extraction of mineral oil within EEZ or continental shelf, then no export has taken place and duty free supply of fuel is not permitted. E. Indian Customs Waters –

Section 2(28) define that ‘Indian Customs Waters’ means the waters extending into the sea up to the limit of contiguous zone of India under section 5 of the Territorial Waters, Continental Shelf, Exclusive Economic Zone and other Maritime Zones Act, 1976, and includes any bay, gulf, harbour, creek or tidal river. As per provisions of that Act, contiguous zone of India comes immediately after territorial waters. The outer limit of contiguous zone is 24 nautical miles from the nearest point of base line. Thus, area beyond 12 nautical miles and upto 24 nautical miles is ‘contagious zone of India’.

The Central Government has powers to take measures in this area for security of India and immigration, sanitation, customs and other fiscal matters. [section 5(4) of Territorial Waters – . – . – . – Act, 1976]. Thus, ‘Indian Customs Waters’ extend upto 12 nautical miles beyond territorial waters. Significance of definition of ‘Indian Customs Waters’ is as follows – | Customs Officer has powers to arrest a person in India or within Indian customs waters. [section 104]. | | Customs officer has powers to stop and search any vessel in India or within the Indian Customs waters. section 106]. If such vessel does not stop, it can be fired upon. If a vessel does not stop, it can be confiscated [section 115(1)(c)]. | | A vessel which is within Indian customs waters or which has been in Indian Customs Waters can be confiscated which is constructed or fitted in any manner for purpose of concealing goods. [section 115(1)(a)]. | Thus, powers of customs officers extend upto 12 nautical miles beyond territorial waters. E. ‘Goods’ under Customs Act – Customs duty is on ‘goods’ as per section 12 of Customs Act.

The duty is payable on goods belonging to Government as well as goods not belonging to Government. Section 2(22), gives inclusive definition of ‘goods’ as – ‘Goods’ includes (a) vessels, aircrafts and vehicles (b) stores (c) baggage (d) currency and negotiable instruments and (e) any other kind of movable property. Thus, ships or aircrafts brought for use in India or for carrying cargo for ports out of India, would be dutiable. Definition of goods has been kept quite wide as Customs Act is used not only to collect duty on ‘goods’ but also to restrict/prohibit import or export of ‘goods’ of any description.

Main two tests for ‘goods’ are (a) they must be movable and (b) they must be marketable. The very fact that goods are transported by sea/air/road means that they are ‘movable’. Since most of imports are on payment basis, test of ‘marketability’ is obviously satisfied. i. Dutiable Goods – Section 2(14) define ‘dutiable goods’ as any goods which are chargeable to duty and on which duty has not been paid. Thus, goods continue to be ‘dutiable’ till they are not cleared from the port. However, once goods are assessed at ‘Nil’ rate of duty, they no more remain ‘dutiable goods’. ii. Imported Goods –

Section 2(25) define ‘imported goods’ as any goods brought in India from a place outside India, but does not include goods which have been cleared for home consumption. Thus, once goods are cleared by customs authorities from customs area, they are no longer ‘imported goods’. (Though in common discussions, goods cleared from customs are also called ‘imported goods’). iii. Export Goods – As per section 2(19) of Customs Act, ‘export goods’ means any goods which are to be taken out of India to a place outside India. Goods brought near customs area for export purpose will be ‘export goods’.

Note that once goods leave Indian territory, Indian laws have no control over them and hence the term ‘exported goods’ has not been used or defined. * Types of Customs Duties Tariff Rates for customs duty are prescribed in Customs Tariff Act, 1975. The types of duties are: Basic, Additional (CVD), Additional (to compensate duty on inputs used by Indian manufacturers), Anti-dumping duty, protective duty, the duty on Bounty Fed articles and safeguard duty. These are explained below. Basic Customs Duty – This is the duty levied under section 12 of Customs Act.

Normally, it is levied as a percentage of Value as determined under section 14(1). The rates vary for different items, but general rate at present is 10%. To protect Indian agriculture and Indian automobile sector, duties on some articles is higher Education cess on customs duty – An education cess has been imposed on imported goods w. e. f. 9-7-2004. The cess will be 2% of the aggregate duty of customs. However, education cess will not be payable on safeguard duty under sections 8B and 8C, countervailing duty under section 9, Anti Dumping Duty under section 9A of the Customs Tariff Act and education cess on imported goods (i. . these duties ). Section 94 of Finance (No. 2) Act, 2004 states that education cess on customs duty a ‘duty of customs’. As per section 94(3) of Finance (No. 2) Act, 2004, all provisions of Customs Act, and rules and regulations made under that Act will apply to education cess on imported goods, including those relating to refund, exemption from duty and imposition of penalty. Secondary and Higher Education Cess – A secondary and higher education cess of 1% of customs duty has been imposed w. e. f. 1-3-2007. A. Additional Customs Duty (CVD) – This is often called ‘Countervailing Duty’ (CVD).

In S K Pattnaik v. State of Orissa 2000 AIR SCW 41 = AIR 2000 SC 612 = 115 ELT 9 = 2000(1) SCC 413 = 1999(7) SCALE 557 (SC 3 member bench), it was observed that ‘countervailing duty’ is imposed when excisable articles are imported, in order to counter balance the excise duty, which is leviable on similar goods if manufactured within the State. Additional duty is levied under section 3(1) of Customs Tariff Act. Thus, it is not a ‘duty under the Customs Act’. – CC v. Indian Organic Chemicals 2000 AIR SCW 1633 = 2000(4) SCALE 321 = 2000(118) ELT 3 (SC).

However, it is ‘duty of customs’. – CC v. Presto Industries 2001 AIR SCW 828 = 2001(2) SCALE 68 = 128 ELT 321 (SC). In this case, it was also held that ‘additional customs duty’ is not called as ‘Countervailing duty’ though it may result in serving such purpose for manufacturer of such articles in India. This duty is equal to excise duty levied on a like product manufactured or produced in India. If like article is not produced or manufactured in India, the excise duty that would be leviable on that article had it been produced in India is the base.

If the product is leviable with different rates, then highest rate among those rates is to be considered. The duty is leviable on Value of goods plus customs duty payable. Thus, assume that Customs Value of goods is Rs. 10,000, customs duty is 30%and excise duty on similar goods manufactured in India is 16%. Then, basic customs duty is Rs 3,000. Additional customs duty (CVD) is payable on value plus basic customs duty, i. e. on Rs 13,000 [Rs 10,000+3,000]. Thus, CVD payable is Rs 2,080 (16% of Rs 13,000).

In addition, SAD (Special Additional Duty) @ 4% is also payable, as explained in an earlier paragraph. SAD @ 4% on Rs 15,080 [10,000+ 3,000 + 2,080] is Rs 603. 20. i. Calculation of CVD – CVD is payable on Assessable Value [as determined u/s 14(1) of Customs Act or tariff value fixed u/s 14(2) of Customs Act] plus  basic customs duty chargeable u/s 12 of Customs Act plus  basic customs duty chargeable u/s 12 of Customs Act plus any other sum chargeable on that article under any law in addition to, and in the same manner as duty of customs (e. g. NCCD of customs).

However, while calculating CVD, following duties are not to be considered – * Special Additional Duty payable u/s 3A of Customs Tariff Act *  Safeguard duty u/ss 8B and 8C of Customs Tariff Act * Countervailing duty, if any, u/s 9 of Customs Tariff Act *  Anti-dumping duty payable u/s 9A of Customs Tariff Act * CVD itself which is payable u/s 3(1). [section 3(2) of Customs Tariff Act]. – – In other words, CVD is payable on assessable value plus basic customs duty plus NCCD of customs. While calculating CVD, Anti Dumping Duty, SAD and safeguard duty is not required to be considered. [This amendment is with retrospective effect from 1-3-2002.

It was also clarified  in Explanatory Note – Customs released with Budget Papers on 28-2-2002]. ii. CVD is not Customs Duty – CVD is leviable under section 3(1) Customs Tariff Act, while customs duty is levied u/s 12 of Customs Act. Thus, these are two separate independent duties. under different statutes. However, u/s 3(6) of Customs Tariff Act, the provisions of Customs Act regarding recovery, payment, drawbacks, exemption, refunds, appeals etc. are applicable to Additional Customs Duty. iii. CVD is not excise duty – Though excise duty rate is considered for measurement or quantifying CVD payable, it is not excise duty. – Mohd.

Zackria v. State of Tamilnadu (1999) 115 STC 697 (TNTST). iv. CVD Payable at effective rate of Excise duty – Additional duty (CVD) is payable at effective rate of duty i. e. any concession granted by a notification should be considered e. g. if Excise Tariff Rate is 25%, but by an unconditional exemption notification, excise duty is reduced to 15%. In such case, additional duty is payable @ 15% and not @ 25%. v. CVD payable if cess or AED is payable on goods manufactured in India – If cess or Additional Excise Duty (AED) is payable on goods manufactured in India, CVD equal to cess or AED leviable on goods manufactured in India is payable. CC v. Birla Jute Industries 1992(61) ELT 554 (CEGAT) * Vareli Textile Industries v. UOI 1997(91) ELT 279 (Guj) * Vikrant Tyres v. CC 2002(144) ELT 554 (CEGAT). vi. CVD payable even if similar goods not produced in India – Additional duty is leviable even if like goods are not produced in India. vii. Additional duty if conditional excise exemption notification- As per case law discussed below, the legal position that emerges is that if conditional exemption is such that it is impossible to be fulfilled, the exemption notification cannot be considered, i. . duty is payable at tariff rate. However, if the requirement is only procedural requirement, exemption notification can be held as applicable, i. e. duty will be payable at effective rate after considering exemption notification. viii. Valuation for CVD when goods are under MRP provisions – In respect of some consumer goods, excise duty is payable on basis of MRP (Maximum Retail Price) printed on the carton as per section 4A of Central Excise Act. If such goods are imported, duty will be payable on basis of MRP printed on the packing, i. . at MRP specified on the packing carton less abatement as permissible u/s 4A of Central Excise Act. [proviso to section 3(2)(ii) of Customs Tariff Act]. However, it has been clarified by DGFT vide policy circular No. 38(RE-2000) / 1997-2002 dated 22. 1. 2001 that labelling requirements for pre-packed commodities are applicable only when they are intended for retail sale. These are not applicable to raw materials, components, bulk imports etc. which will undergo further processing or assembly before they are sold to consumers.

B. Additional Duty under section 3(3) – In addition to Additional Duty under section 3(1) of Customs Tariff Act; which is chargeable on all goods, further additional duty can be levied by Central Government to counter-balance excise duty leviable on raw materials, components etc. similar to those used in production of such article. [Section 3(3) of Customs Tariff Act]. Central Government has issued notifications under this section levying additional duty on stainless steel manufactures for household use and transformer oil.

After extension of Cenvat to most of commodities, there is no need to counter-balance the duty paid on inputs. C. Protective Duties – ‘Tariff Commission’ has been established under Tariff Commission Act, 1951. If the Tariff Commission recommends and Central Government is satisfied that immediate action is necessary to protect interests of Indian industry, protective customs duty at the rate recommended may be imposed under section 6 of Customs Tariff Act. This notification should be introduced in Parliament in next session by way of a Bill. or in the same session if Parliament is in session). If the Bill is not passed within six months of introduction in Parliament, the notification ceases to have force, but action already taken remains valid. The protective duty will be valid till the date prescribed in the notification. The protective duty can be rescinded, reduced or increased by a notification. Such notification should also be placed before Parliament for approval in next session. [This duty does not seem to be compatible with WTO regulations] D. Countervailing duty on subsidised goods –

If a country pays any subsidy (directly or indirectly) to its exporters for exporting goods to India, Central Government can impose Countervailing duty upto the amount of such subsidy under section 9 of Customs Tariff Act. If the amount of subsidy cannot be ascertained, provisional duty can be collected and after final determination, difference may be refunded. Such imposition should be by way of a notification. Customs Tariff (Identification, Assessment and Collection of Countervailing Duty on Subsidised Articles and for determination of Injury) Rules, 1995 [Customs Notification No. 1/95 (N. T. dated 1-1-95 provide detailed procedure for determining the injury in case of subsidised articles. ] E. Anti Dumping Duty on dumped articles – Often, large manufacturer from abroad may export goods at very low prices compared to prices in his domestic market. Such dumping may be with intention to cripple domestic industry or to dispose of their excess stock. This is called ‘dumping’. In order to avoid such dumping, Central Government can impose, under section 9A of Customs Tariff Act, anti-dumping duty upto margin of dumping on such articles, if the goods are being sold at less than its normal value.

Levy of such anti-dumping duty is permissible as per WTO agreement. Anti dumping action can be taken only when there is an Indian industry producing ‘like articles’. Pending determination of margin of dumping, duty can be imposed on provisional basis. After dumping duty is finally determined, Central Government can reduce such duty and refund duty extra collected than that finally calculated. Such duty can be imposed upto 90 days prior to date of notification, if there is history of dumping which importer was aware or where serious injury is caused due to dumping. Margin of dumping’ means the difference between normal value and export price (i. e. the price at which these goods are exported). [section 9A(1)(a)]. ‘Normal Value’ means comparable price in ordinary course in trade, for consumption in the exporting country or territory. If such price is not available or not comparable, comparable representative price of like article exported from exporting country or territory to appropriate third country can be considered. [section 9A(1)(c)]. ‘Export Price’ means the price at which goods are exported.

If the export price is unreliable due to association or compensatory arrangement between exporter and importer or a third party, export price can be constructed (revised) on the basis of price at which the imported articles are first sold to independent buyer or according to rules made for determining margin of dumping. [section 9A(1)(b)]. Margin of dumping is determined on basis of weighted average of ‘normal value’ and the ‘export price’ of product under consideration. In Volznsky Pipe Plant v. Designated Authority 2001(129) ELT 408 (CEGAT), it was held that domestic price of foreign exporter in his country should be considered, provided it s not below per unit cost of production plus administrative selling and general cost. (i. e. overheads) In case of non-market economy countries (mostly communist countries), ‘normal value’ can be determined on basis of price in a market economy third country, price paid in India for a like product or any other reasonable basis. As per para 8 of Annexure I to Anti-Dumping Duty Rules, ‘non-market economy’ means any country which the designated authority determines as not operating on market principles of cost or pricing structure, so that the sales in such country do not reflect the fair value of merchandise.

Designated Authority will consider various aspects to determine whether the country is a market economy. i. Dumping duty for WTO countries – Section 9B provide restrictions on imposing dumping duties in case of imports from WTO countries or countries given `Most Favoured Nation’ by an agreement. Dumping duty can be levied on import from such countries, only if Central Government declares that import of such articles in India causes material injury to industry established in India or materially retards establishment of industry in India. WTO agreement permits levy of anti-dumping duty when it causes injury to domestic industry as a result of specific unfair trade practice by foreign producer, by selling below normal value]. ‘Injury to domestic industry’ will be considered on basis of volume effect and price effect on Indian industry. There must be a ‘casual link’ between material injury being suffered by dumped articles and the dumped imports. . Imposition of minimum anti-dumping duty is not permissible in law. – Oswal Woollen Mills v. Designated Authority 2000(118) ELT 275 (CEGAT). ii.

Gains to other sections not considered – In India, only injury to concerned local industry is considered, but gains to other industry and economy in general due to availability of imports at lower prices are not considered, i. e. welfare of society at large is not taken into account. This principle is adopted in Europe and in certain cases, dumping duties were not imposed, even when dumping was established, considering that public at large is being benefited. iii. Quantum of dumping duty – The anti-dumping duty will be dumping margin or injury margin, whichever is lower. Injury margin’ means difference between fair selling price of domestic industry and landed cost of imported product. The landed cost will include landing charges of 1% and basic customs duty. Thus, only anti-dumping duty enough to remove injury to domestic industry can be levied. iv. No anti dumping duty in certain cases – Anti-dumping duty is not applicable for imports by EOU or SEZ units, unless it is specifically made applicable in the notification imposing anti-dumping duty. [section 9A(2A) of Customs Tariff Act] v. No CVD or SAD on anti dumping duty –

Anti Dumping Duty and Safeguard Duty is not required to be considered while calculating CVD or SAD. vi. No Anti dumping duty on goods warehoused prior to levy of anti dumping duty – Anti dumping duty is leviable on date of importation. Hence, if goods are already warehoused prior to imposition of anti-dumping duty, anti-dumping duty will not be leviable on warehoused goods, even if cleared subsequent to imposition of anti-dumping duty. Section 15(1)(b) of Customs Act does not apply to anti-dumping duty u/s 9A of Customs Tariff Act. – CC v. Suja Rubber Industries 2002(142) ELT 586 (CEGAT).

Rules for deciding subsidy or dumping margin – Central Government has been empowered to make rules for determining (a) subsidy or bounty in case of bounty fed goods (b) the normal value and export price to determine margin of dumping in case of dumping. Accordingly, Customs Tariff (Identification, Assessment and Collection of Anti-dumping duty on Dumped Articles and for determination of Injury) Rules, 1995 [Customs Notification No. 2/95 (N. T. ) dated 1-1-95] provide detailed procedure for determining the injury in case of dumped articles. for detailed guide and forms – see Chartered Secretary, Nov. 1998 page 1168 to 1179] Under the rules, Central Government will appoint a person as ‘Designated Authority’. Complaint with all details and evidence should be made to Designated Authority, Directorate General of Anti-Dumping and Allied Duties, Ministry of Commerce, Govt. of India, Udyog Bhavan, New Delhi – 110 011. The information, as required in trade notice No. 1/98 dated 15. 5. 1998, issued by Directorate General of Anti-Dumping and Allied Duties should be furnished.

He will normally initiate enquiry on receiving request from affected domestic industry. Domestic producers supporting the application must account for at least 25% of production in India. However, even suo motu enquiry can be initiated. Appeal against order determining dumping duty  – Appeal against the order determining the duty can be made to CESTAT. The appeal will be heard by at least three member bench consisting of President, one judicial member and one technical member [section 9C of Customs Tariff Act]. F. Safeguard duty –

Central Government is empowered to impose ‘safeguard duty’ on specified imported goods if Central Government is satisfied that the goods are being imported in large quantities and under such conditions that they are causing or threatening to cause serious injury to domestic industry. Such duty is permissible under WTO agreement. The only condition under WTO is that it should not discriminate between imports from different countries having Most Favoured Nation (MFN) status. Safeguard duty is a step in providing a need based protection to domestic industry for a limited period, with ultimate objective of restoring free and fair competition.

Safeguard duty is targeted at remedying or preventing serious injury to domestic industry with a view to making it competitive and to enable it to stand on its own. – Mr. R K Gupta – (Earlier) Director General (Safeguards). Government has to conduct an enquiry and then issue a notification. [section 8B(1) of Customs Tariff Act]. The duty, once imposed, is valid for four years, unless revoked earlier. This can be extended by Central Government, but total period of ‘safeguard duty’ cannot be more than ten years. [section 8B(4)]. The duty is in addition to any other customs duty being imposed on the goods. section 8B(3)]. In case of imports from developing countries, such safeguard duty can be imposed only if import of that article from that country is more than 3% of total imports of that article in India. [proviso to section 8B(1)]. Central Government can impose provisional safeguard duty, pending final determination upto 200 days. [section 8B(2) of Customs Tariff Act]. [This provision has been added w. e. f. 14th May, 1997]. ‘Customs Tariff (Identification and Assessment of Safeguard Duty) Rule, 1997 have been notified on 29. 7. 1997, providing for procedure for investigation and fixing safeguard duty.

Mr. R K Gupta in office of Director General of Inspection, Customs ; CE has been appointed as Director General (Safeguards), vide notification No 45/97-Cus dated 16. 9. 1997. He has issued a trade notice dated 26. 9. 97, indicating details required to be submitted and procedure to be followed. Some orders issued under these provisions have been summarised in an Article in Chartered Secretary – July 1999. – page 736. i. Concession on TRQ basis – Central government can exempt specified quantity of article imported into India, from whole or part of safeguard duty leviable thereon. section 8B(2) of Customs Tariff Act]. The provision has been made to enable Central Government to grant exemption from safeguard duty on Tariff Rate Quota (TRQ) basis. ii. No safeguard Duty in certain cases – Safeguard duty is not applicable for imports by EOU or SEZ units, unless it is specifically made applicable in the notification imposing anti-dumping duty. [section 8B(2A) of Customs Tariff Act] iii. No CVD on Safeguard Duty – CVD is to be calculated on Assessable Value plus basic customs duty. However, Anti Dumping Duty and Safeguard Duty is not required to be considered while calculating CVD.

G. Product specific safeguard duty on imports from China – Besides general provisions in respect of Safeguard duty (u/s 8B as above), special provisions of safeguard duty is made in respect of goods imported from Peoples Republic of China by inserting section 8C to Customs Tariff Act w. e. f. 11-5-2002. Central Government is empowered to impose ‘product specific safeguard duty’ on any article imported from China, if the quantities are increased and such import is causing or threatening to cause market disruption to domestic industry. [section 8C(1)].

Provisional duty can be imposed on basis of preliminary finding. However, if on final determination, it is found that the imports have not caused market disruption to a domestic industry, the safeguard duty provisionally collected is refundable. Such product specific safeguard duty is not payable in respect of imports by EOU / SEZ units unless specifically made applicable to them . [section 8C(3)]. Government will make rule prescribing mode of identifying the threat and then how to assess and collect the safeguard duty. The duty can be imposed for maximum four years.

It can be extended to safeguard interests of domestic industry, but maximum period cannot exceed 10 years. ‘Domestic Industry’ means either producer of whole of India or producers having major share of total production of that article in India. ‘Market disruption’ shall be caused whenever the imports of a like article or a directly competitive article produced by the domestic industry, increases rapidly, either absolutely or relatively, so as to be a significant cause of material injury, or threat of material injury to domestic industry.

The threat of market disruption should be clear and imminent danger of market disruption. [section 8C(7)]. Customs Tariff (Transitional Product Specific Safeguard Duty) Rules, 2002 make provisions for determining the safeguard duty. Director General (Specific Safeguard) will be appointed. He will investigate and submit his report on market disruption or threat to market disruption to domestic industry on any article due to imports from Ch

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Import of Raw Materials 4 Pharmacy Products. (2018, May 06). Retrieved from https://graduateway.com/import-of-raw-materials-4-pharmacy-products-essay/

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