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the Drugs and Cosmetics Act, 1940
The Central Excise Tariff Act, 1985
The British Statutes (Repeal) Act, 2004
Espi Industries And Chemicals ... vs Collector Of Central Excise, ... on 9 March, 1995
The Trade And Merchandise Marks Act, 1958

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Customs, Excise and Gold Tribunal - Delhi
Neo Pharma (P) Ltd. vs Collector Of Central Excise on 1 December, 1995
Equivalent citations: 1996 (82) ELT 49 Tri Del

ORDER

S.L. Peeran, Member (J)

1. In both these appeals, common question of law and facts arises, hence they are taken together for disposal as per law. The question which arises for our determination in these appeals is the question of correct classification of the product "Siloderm Ointment". The appellants had sought the classification under sub-heading 3003.10 of Central Excise Tariff Act, 1985 while the department has classified the product under sub-heading 3304.00 attracting duty @ 110% ad valorem.

2. Appeal E/871/92-C arises from order-in-appeal dated 13-1-1992 12/821 50 EXCISE LAW TIMES passed by the Collector (Appeals), Bombay, who, allowed the application filed by the Assistant Collector and rejected the appeal of the assessee. The assistant Collector in the order-in-original had accorded approval to classification list No. R. II/H/27/90-91 for the Siloderm Ointment under sub-heading 3003.10 which had been challenged by the Revenue on the ground that the product contains Dimethicone B.P.C., Zinc Oxide I.P. Calamine I.P. and Cetramide which are basically used in products to protect the skin from skin irritants and disinfecting wounds. The product has been described on the carton, as a skin protective barrier ointment. As per Chapter 33 Note 5, barrier creams are classified under Chapter sub-heading 3304.00 attracting 105% ad valorem basic duty plus 5% special excise duty. According to Note 2 under Chapter 33, Heading Nos. 33.03 to 33.07 apply inter alias to products whether or not they contain subsidiary pharmaceutical or antiseptic 3constitutents, or are held out as having subsidiary curative or prophylatic value. As "Siloderm Ointment" contains ingredients which are basically used for the protection of skin against irritants and for dis-infecting wounds, the product would merit classification under Chapter 33, and such products would not be covered under Chapter 30, i.e. pharmaceutical products, even if they have therapeutic or prophylactic properties as per Chapter 30 Note 1(d).

3. By the impugned order-in-original, the Assistant Collector had confirmed a demand of Rs. 38,93,157.10 under Section 11A of Central Excises and Salt Act, 1944. The assessee being aggrieved had also filed their appeal before the Collector (Appeals). The assesses had submitted that -

(i) for the purpose of classification, the opinion expressed by those administering or dealing with the item is required to be taken into consideration. In this regard, they had relied on the certificates and classification adopted by the Drug Commissioner, New Delhi recognizes Siloderm Ointment as medicament. It had been under the Drugs Prices Control Order. Even the Food and Drug Administration, State of Maharashtra, had classified the said Siloderm Ointment as a drug.

(ii) They claimed the Siloderm Ointment manufactured by them is a medicament and not merely a cosmetic with therapeutic treatment. Under Chapter 33, which deals with cosmetics, Chapter Note 5 talks of Barrier cream to give protection against skin irritants. Thus by its very definition, it must be used prior to irritation. The product siloderm ointment is far more advanced than merely being barrier cream to give protection against skin irritants. This ointment is used not so much for protection as for healing and curing-after a disease has cured. It cures bed sores in immobile patients which would otherwise lead to gangrene and death. It cures skin diseases which result from incontinency and colostomy. It cures nappy rash in babies which would result in grave harm and injury to the baby's life if not treated.

(iii) Chapter 33 is basically a chapter on cosmetics or toilet preparations. That is why the words used in Chapter Note 5 are carefully chosen, namely, Barrier Cream' to give protection against skin irritants. The emphasis is that such a barrier cream is a cosmetic cream which is used to protect skin. Such a cosmetic cream does not heal or cure. It only protects.

(iv) All the ingredients of the disputed product siloderm ointment are recognized medications for healing or curing.

(v) Normally when a person buys a cosmetic, barrier protection cream, he will not purchase Siloderm Ointment. Similarly, for curing or healing bedsores, skin diseases and rash, a doctor will not prescribe a cosmetic barrier cream but he will only prescribe Siloderm Ointment. Usually in the drug market Siloderm Ointment is sold on prescription to hospitals, doctors and patients suffering from bed sores, skin diseases and rash for healing.

(vi) In any case, it is settled law that change of a long standing classification approved by the department is not justified unless there is a change in composition or some new fact has emerged which was now known in the past.

4. The Id. Collector took up both the appeal of the department together and decided the case against the assesses and in favour of the Revenue. The Id. Collector has taken into consideration the judgment of the Tribunal in the case of Espi Industries & Chemicals Pvt. Ltd. v. Collector of Central Excise as reported in 1991 (53) E.L.T. 618. The Id. Collector referring to the Tribunal's judgment and the discussion of the Tribunal in respect of product Oil of Olay is to be treated as barrier cream held that the item in question satisfies the characteristics of barrier cream in all respects and as reported in 'Martindale, The Extra Pharmacopoeia - 28th Edition' which he has held that the reading of Pharmacopoeia, it is seen that the use of silicone barrier cream is identical to the use for which the product siloderm ointment is used. He has taken into consideration Note 5 to Chapter 33 which provides that Heading No. 33.04 applies inter alia to barrier creams to give protection against skin irritants Note 2 to Chapter 33 provides that Heading 33.04 includes products whether or not they contain subsidiary pharmaceutical or antiseptic constituents, or are held out as having subsidiary curative or prophylactic value. Note 1(d) to Chapter 30 provides that preparations of Chapter 33 even if they have therapeutic or prophylactic properties are not covered by Chapter 30. In this view of the matter, the Id. Collector upheld the Revenue's contention and confirm the duty for six months prior to the issue of show cause notice.

5. E/4333/95-C : The appellants challenged the confirmation of demand before the Collector (Appeals) as a result of classification of the product under 3304.00, which had been confirmed by the Appellate Collector by his order, dated 13-1-1992 which is subject matter of the Appeal No. E/871/92-C. The Id. Collector has confirmed the demand raised by the Assistant Collector in terms of the order passed earlier by the Collector (Appeals) as referred to.

6. We have heard Id. Advocate Shri Rohan Shah for the appellants and Shri Sanjeev Sachdeva, Id. SDR for the Revenue. At the outset, Id. Advocate submitted that the judgment of the Tribunal referred to by Collector (Appeals) in his order dated 13-1-1992 has since been set aside by Hon'ble Supreme Court in Civil Appeal No. 3956/91 filed by Espi Industries and Chemicals Pvt. Ltd. v. Collector of Central Excise. He has pointed out to the order wherein the Hon'ble Supreme Court has taken a view that the product "Oil of Olay" (Barrier Cream) which has been manufactured under and in accordance with a licence issued by the concerned department under the Drugs and Cosmetics Act is a barrier cream and is classifiable under Heading 3304.00. It is his submission that this case has to be viewed independently of the finding given by the Hon'ble Supreme Court in the case of Espi Industries and Chemicals Pvt. Ltd., as that case dealt only with the grant of the benefit of the Notification which exempted "barrier creams" falling under sub-heading 3304.00 of the Schedule to the Central Excise Tariff Act,1985. The Tribunal had rejected the plea of the assessee on the ground that the product was not a barrier cream but only a beauty cream. The Id. Counsel emphasises the finding of the Hon'ble Supreme Court which held that - "the mere fact that it is also described as a beauty cream does not necessarily exclude it from being a barrier cream".

The Id. Advocate's contention is that the product in question is a medicament, which helps in the process of skin healing and all the ingredients used are of BPC and IP standard and therefore, it has to be classified under Chapter-heading 30.03 as a medicament. In this context, he submitted that the product has been considered as a medicament under the Drugs and Cosmetics Act and also by all the physicians, who prescribes this ointment as a medicine for skin diseases. Ld. Advocate referred to the Technical literature more particularly to the Martindale, The Extra Pharmacopoeia and British Pharmaceutical Codex, 1973 wherein all the ingredients are mentioned. He relied on the judgments relied in the case of

(i) G.D. Pharmaceuticals Ltd. v. Collector of Central Excise, Merrut - 1995 (79) E.L.T. 442 (Tri.)1995 (9) R.L.T. 870

(ii) B.P.L. Pharmaceuticals Ltd. v. Collector of Central Excise, Vadodara - 1995 77) E.L.T. 485 (SC)

(iii) Alpine Industries v. Collector of Central Excise - 1995 (10) R.L.T. 416

7. Ld. DR submits that the dispute is not as to whether the item is a drug or cosmetic but dispute is as to whether the item is a PP medicine or a barrier cream. He submitted that cosmetic may be a drug for the Drugs Act but it has to be treated as a cosmetic for the purpose of Central Excise Tariff. He submitted that the item is sold as a barrier cream and therefore, applying Note 5 to Chapter 33, the item is required to be classified under Chapter Heading 3304. He also referred to Note 1(d) of Chapter 30, which excludes the preparation of Chapter 33, even if they have therapeutic or prophylactic properties. Ld. Advocate submitted in counter that the present item is not covered under Chapter 33 as contended by Ld. DR.

8. We have carefully considered the submissions made by both the sides and findings in these appeals are as follows :-

"The ld. Collector has considered the product "Siloderm Ointment" to contain ingredients which are basically used for the protection of skin against irritants and for disinfeeling wounds, and hence applying Note 1(d) of Chapter 30, which reads :

Preparation of Chapter 33 even if they have therapeutic or prophylactic properties".

has excluded the product from the ambit of Chapter 30 and classified the product as a "barrier cream to give protection against skin irritants", under Chapter heading 33.04, which reads : "Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen and suntan preparations, manicure or pedicure preparations" 105%

The Id. Collector has also applied Notes 2 & 5 of the Chapter 33 which reads as follows :

"Note 2 - Heading Nos. 33.03 to 33.07, apply, inter alia, to products, whether or not mixed (other than aqueous distillates and aqueous solutions of essential oils), suitable for use as goods of these headings and put up in packings with labels, literature or other indications that they are for use as cosmetics or toilet preparations or put up in a form clearly specialised to such use and includes products whether or not they contain subsidiary pharmaceutical or antiseptic constituents, or are held out as having subsidiary, curative or prophylactic value.

Note 5 - Heading No. 33.03 applies, inter alia, to the following products: beauty creams, vanishing creams, cold creams, make-up creams, cleaning creams, skin foods, skin tonics face powders, baby powders, toilet powders talcum powders and grease paints, lipsticks, eye shadow and eyebrow pencils, nail polishes and varnishes, cuticle removers and other preparations for use in manicure or chiropody and barrier creams to give protection against skin irritants."

9. The appellant's contention is that note 1(d) of Chapter 30 is not applicable, as the product is not a mere preparation to give protection against skin irritants but it is a "medicaments" and is covered by Chapter Note 2 of the Chapter 30 and being a recognized medications for healing or curing bed sores, napkin rash and to protect the skin against trauma due to inconvenience of urine and faeces or ileostomy or colostomy discharge, contact dermatities and pruvitus. One ingredient of the product, Silicone, is also injected intra-ar-ticularly in Osteo and Rheumatoid Arthritis. They therefore, rely on Note 2 of Chapter 30, to seek classification under Chapter sub-heading 3003.10 which reads as follows : "3003.10 - Patent or proprietary medicaments, other than those medicaments which are exclusively Ayurvedic, Unani, Siddha, Homoeopathic or Bio-chemic 15%"

The Note 2 of Chapter 30 is reproduced herein below :

"Note 2 : For the purposes of Heading No. 30.03 :

(i) "Medicaments" means goods (other than foods or beverages such as dietetic, diabetic or fortfied foods, tonic beverages) not falling within heading No. 30.02 or 30.04 which are either :

(a) products comprising two or more constituents which have been mixed or compounded together for therapeutic or prophylactic uses; or

(b) unmixed products suitable for such use, put up in measured doses or in packings for retail sale or for use in hospitals.

(ii) patent or proprietary medicaments' means any drug or medicinal preparation, in whatever form, for use in the internal or external treatment of, or for the prevention of ailments in human beings or animals, which bears either on itself or on its container or both, a name which is not specified in a monograph, in a Pharmacopoeia, Formulary or other publications, namely :

(a) The Indian Pharmacopoeia;

(b) The International Pharmacopoeia

(c) The National Formulary of India

(d) The British Pharmacopoeia;

(e) The British Pharmaceutical Codex;

(f) The British Veterinary Codex;

(g) The United States Pharmacopoeia;

(h) The National Formulary of the U.S.A.;

(i) The Dental Formulary of the U.S.A.; and

(j) The State Pharmacopoeia of the U.S.S.R.

of which is a brand name, that is, a name of registered trade mark under the Trade and Merchandise Marks Act, 1958 (43 of 1958), or any other mark such as a symbol monogram, label signature or invented words or any writing which is used in relation to that medicine for the purpose of indicating or so as to indicate a connection in the course of trade between the medicine and some person, having the right either as proprietor of otherwise to use the name or mark with or without any indication of the identity of that person."

The question is as to whether the item is "a preparation of Chapter 33" to be excluded from Chapter 30 as per Note 1(d) of Chapter 30.

Chapter Notes 2 and 5 of Chapter 33 takes within its ambit products suitable for use as goods of the Headings 33.03 to 33.07 which are put up in packings with labels, literature or other indications that they are for use as cosmetics or toilet preparations or put up in a form clearly specialised to such use and includes products whether or not they contain subsidiary pharmaceutical or antiseptic constituents or are held out as having subsidiary, curative or prophylactic value.

Although, the product is put up in packings with labels and literature, but, the item is not a cosmetic or toilet preparation or a mere barrier cream to give protection to skin and it has not been put up in a form clearly specialised for such use. The Note 2 of Chapter 33 states that the product should be put to use as cosmetics or toilet preparation or of any item of such use and it is classified in these headings irrespective of such items containing subsidiary. Pharmaceutical or antiseptic constituents, or even those which are held out as having subsidiary, curative or prophylactic value. This means that a product may be per se a cosmetics or toilet preparation or barrier cream, but may have due to its ingredients some antiseptic, curative or prophylactic value, but that by itself, will not take it out from Chapter 33. Note 5 of Chapter 33 lists the products, which are in the nature of cosmetic, toilet preparation and skin care ointments etc. and also Barrier Creams to give protection against skin irritants. Barrier Creams may have some curative or prophylactic value, but by this property itself, it is not to be considered as a medicament and it is to be classified under the Chapter 33 only. Revenue has proceeded to consider the product in question as a Barrier Cream, which is used for protection against skin irritants and therefore, has applied Note 1(d) of Chapter 30 to exclude from Chapter 30 and applying Notes 2 & 5 of Chapter 33 has placed the product under Chapter sub-heading 3304.

10. On a careful consideration of the materials on record, we are of the opinion that the Revenue is clearly in error in disregarding the product as a medicaments and considering it merely as a barrier cream and to give protection against skin irritants. The appellants have produced enormous evidence both technical and many certificates from doctors and skin specialists to assert that the product is used as a medicament for treatment of skin diseases. The reply dated 29-6-1990 given to the Superintendent of Central Excise, explaining the details of the products is required to be extracted herein below to show the nature of the ingredients and its uses in treatment of skin conditions recognised in technical literature. The said reply is extraced herein below :

"To

The Superintendent,

Central Excise Range II

Division 'H'

Bombay.

Dear Sir,

Pursuant to the visit of your Inspector to our factory at Santacruz, on Thursday 28th June, 1990, we wish to inform you as follows :

(1) Dimethicone-20 is a medicinal drug mentioned in various International Pharmacopoies e.g. British, European, China, Netherland and Swiss. It is also mentioned in I.S.N.F. It is employed for the management of Bed Sores and Napkin Rash and to protect the skin against trauma due to incontinent of urine and faeces or Ileostomy or colostomy discharge. Of late Dimethicone-20 a silicone alongwith hydrocortisons is injected intra-articularly in osteo and rheumatoid arthritis. It has been also used in treatment of flatulence where it exerts its action by converting a large number of small bubbles into small number of large bubbles which can be easily expelled through the anus as flatus thus obtaining relief from distension of the abdomen.

(2) Dimethicone-20 plays an important therapeutic role in healing of bed sores which normally occur in patients suffering from hamiplogia, paraplegia and also those patients who are in coma and confined to bed for prolonged periods.

In support of above claim, we give below an extract from a leading medical journal:

"A bed sore in an 86 years old man healed completely in 4/5 months when an ointment containing 20% dimethicone was applied twice daily. Within two days of the treatment starting, the serous secretion ceased and the surface of the ulcer began to heal."

P. M.C. Ezvan (letter), Lancet, 1/1968, 45

In further support of our above claim we also enclose clinical trials reports (Annexure 1, II, III) extracted from leading medical journals which prove beyond doubt that Siloderm plays an important therapeutic role in healing of bed sores and has been classified as a therapeutic medicinal drug.

Siloderm also plays a very important therapeutic role in the management of skin around ileostomies and colostomies.

In support of the above claim we have pleasure in submitting an extract (Annexure IV) from a leading medical journal which also clearly proves beyond doubt that Siloderm is a medicinal durg used in therapeutic management of various dermal ailments.

(3) Dimethicone is also employed in the treatment of osteo-arthritis and rheumatoid arthritis. Here it reduces friction, wear and tear and thus helps the patient to become ambulant without pain.

In support of this claim we reproduce below the extract from a leading medical journal:

"Inter-articular injections of dimethicone relieved painful, dry, grating stable knees for 4 months in some patients and of these, a third were maintained for 3 years with less than 4 injections. Subjective relief was obtained in 89% of over 140 Joints and objective improvement in 54%. "Burnt out" rhsumatoid joints appeared to benefit more than cateo-arthritic joints".

B. Halal at si. bit, Surg., 1970, 54, 317, per Drug. Basle 1972, 3, 289, See also Halal (letter) British Medical journal.

(4) Dimethicone is also employed in treatment of burns in U.S.A. The burnt part is immersed in the sterile silicone oil and heals rapidly without cicatrisation of the tissues. The therapeutic results are so good that even 2nd and 3rd degree burns heal without any deformity, with practically reduced morbidity and mortality.

In support of our above claim we give below an extract from a leading medical journals :

"Immersion of burnt hands in liquid silicone lead to early debridsment and removal of eacher. There was lack of pain during treatment and control of infection was good."

J.W. Batdrofat el, Arche Surg., Chicago, 1969, 98, 469 per /. Am. Mad. Ass. 1969, 208, 552.

(5) Silicone fluid (Dimethicone) is also employed to replace witreous when it has undergo degenerative changes or in case of intra-ocular haemorrhage.

In support of our above claim we give below an extract from a leading medical journal :

"Silicone fluids had been used to replace the degenerative fluid witreous in cases of retinal detachment and to replace haemorrhagic witreous. When injected intravitreously no evidence of cell or tissue reaction or interference with retinal function was seen in animals or human. "

M-F Armaly, J. Am. Med. Ass. 1960,198, 214

(6) Last but not the least is that Dimethicone was used in the treatment of handsdemaged by trauma or operations. The hands were immersed and exercised in the oil for 20 minutes upto 3 times daily often starting the day after injury. The treatment facilitated movement of hands and abridement of dead tissue and hastened the formation of granulation.

D. Gifford, Physiotherapy, bond., 1974, 60, 350.

Again Zinc oxide and calamine the other ingredients present in Siloderm exert soothing and antiseptic action and thus prevent secondary infection in damaged skin. Zinc oxide and calamine are also medicinal drugs as mentioned in various international pharmacopoeias.

From the above it is concluded that Siloderm is a medicament or a drug used in medicine for various aliments of the skin.

Sd/-          

(V.K. Patil)       

Dy. Factory Manager"

A reading of the technical literature and the certificates issued by doctors clearly rule out the product as a cosmetic or toilet preparation or as a mere Barrier Cream, to give protection against skin irritants and hence Note 1(d) of Chapter 30 is not applicable to the facts of this case. So also Chapter Notes 2 and 5 of Chapter 33 the product in question is clearly a medicament as per the definition given in Note 2 of Chapter 30, and all the ingredients are mentioned in Pharmacopoeia. The product is sold in the name of 'siloderm ointment', it is not specified in a monograph or in a pharmacopoeia, Formulary or other publications, as mentioned in Note 2(ii) of Chapter 30. The product bears on itself and its container, a name of "siloderm ointment" which is a registered brand name, and which is used in relation to the medicine for the purpose of indicating a connection in the course of trade between this medicine and the appellants who are the proprietors of this trade name. Hence, the product satisfies the definition of "patent or proprietary medicaments" to be classified under Chapter sub-heading 3303.10 of Central Excise Tariff as amended on 1-7-1990. Therefore, the appellants should succeed in these appeals. Thus, the appeals are allowed, and the impugned orders are set-aside, with consequential relief, if any.