Commnr. Of Central Excise vs M/S. Wockhardt Life Science Ltd

1. These appeals are directed against the judgment and

order passed by the Customs, Excise and Gold (Control)

Appellate Tribunal, West Zonal Bench at Mumbai in Appeal

Nos.E-1252-1271/02-MUM and E/3630-01-MUM dated

18.6.2003. By the impugned judgment and order, the

Tribunal has reversed the findings and conclusions reached

both by the Adjudicating Authority and the appellate

authority.

2. The primary issue that falls for our consideration in

these appeals is the classification of two products viz.

`Povidone Iodine Cleansing Solution USP and Wokadine

Surgical Scrub for the purpose of levy of duty under the

provisions of Central Excise Tariff Act, 1985 (`The Tariff Act'

for short).

1 3. The assessee is the manufacturer of Povidone Iodine

Cleansing Solution USP and Wokadine Surgical Scrub.

These two products have identical composition. The only

difference between these two products is that Wokadine is a

branded product whereas Povidone Iodine Cleansing

Solution is a generic name. The assessees' claim before the

authorities and also before the Tribunal is that the aforesaid

products are medicaments and, therefore, require to be

classified under Chapter sub-heading 3003 of the Tariff Act,

1985, whereas the revenue's stand was that the products in

question are detergents and, therefore, to be classified

under chapter sub-heading 3402.90.

4. The Adjudicating Authority had issued nearly 20 show

cause notices to the assessee for the period commencing

from September, 1992 to December, 1999. In the show

cause notices, it is alleged that the assessee has mis-

classified the product under chapter sub-heading

3003.10/20, instead of chapter sub-heading 3402.90 of the

Act with an intent to evade the payment of the duty by

suppressing vital facts regarding usage of the product and

the same amounts to contravention of Rule 173B of the

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Central Excise Rules, 1944 (for short "Rules"). It is further

stated in the show cause notices that the products in

question are mainly used for the purpose of detergents

rather than medicaments. Accordingly, the assessee was

directed to show cause why the products in question should

not be classified under chapter sub-heading 3402.90 and

why the duty should not be demanded under Rule 9(2) read

with proviso to section 11A (1) of the Central Excise Act,

1944 (for Short "the Act of 1944") along with interest

thereon under Section 11AB of the Act of 1944 and penalty

under Section 11 AC of the Act of 1944 read with Rule 173

Q of the Rules for short payment of excise duty.

5. After receipt of the show cause notices, the assessee

had filed its detailed reply, inter alia, bringing to the notice

of the adjudicating authority the contents of the products in

question, their labeling on the commodity and the user to

which the products are put. The assessee had also relied on

the various shades of meaning that is attributed to the

medicaments, in particular the expressions `therapeutic and

prophylactic' and had contended that those medicines are

used for external treatment of a human-being. The assessee

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had also placed reliance on the Indian Pharmacopoeia, the

United States Pharmacopoeia and the International

Pharmacopoeia. The assessee had also contended that the

`Neutronix and Superamide' are other two products with

which Povidone Iodine is mixed to contend that they are in

the nature of vehiculars for the spreading of the

medicament.

6. After receipt of the reply so filed, the adjudicating

authority has proceeded to conclude, that, since the

contents of Neutronix and Superamide are more than the

medicament, namely; Povidone Iodine, the product in

question requires to be classified as detergent and thereby,

would fall under chapter sub-heading 3402.90 and it has

also observed in its order that the product in question is

primarily used as a cleansing solution and, therefore,

cannot fall in the description of the medicament.

Accordingly, had confirmed the show cause notices issued

earlier and, thereby, had directed the assessee to pay the

difference in duty and also the penalty.

7. Aggrieved by the aforesaid order passed by the

4

adjudicating authority, the assessee had carried the matter

in appeal before the First Appellate Authority, who by his

order dated 29.11.2001 had sustained the order passed by

the adjudicating authority. According to the appellate

authority, since the product in question is mainly used as a

cleansing solution, the proper classification would be as a

detergent and would fall under tariff entry 3402.90.

8. The assessee, being aggrieved by the order so passed,

had carried the matter in appeal before the Tribunal. Even

before the Tribunal, the assessee had produced copious

material in the form of product literature and also the

dictionary meaning of the expression "medicaments". The

Tribunal, while appreciating the rival contentions of the

revenue and the assessee, has considered the wide range of

literature on the above products, their composition and user

and accordingly has concluded that the `Povidone Iodine

Cleansing Solution USP' is used as an antiseptic and

disinfectant. The Tribunal has further observed that the

main contention of the revenue is that the addition of

surface active agent and other substances would result in a

product in which `Prophylactic' qualities of Povidone Iodine

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would become subsidiary to its primary use as a washing

solution. The Tribunal, while rejecting the revenue's

contentions and accepting the assesse's stand, has observed

that the presence of the surface active agent and other

substances is only to ensure appropriate dispersible to the

product and not to render its use as a washing or cleansing

preparation. The Tribunal, while relying on the Affidavit

dated 9.8.2002 filed by the Senior President (Marketing) of

the assessee in order to show sale pattern of the goods, has

observed that the product is not used as a general cleansing

solution similar to medicated soaps used by ordinary

persons, but it is only used in places where practice of

surgery and medicine is being carried out. The Tribunal has

further observed that the products are packed in opaque

brown thick plastic bottles with plain labels, unlike, soaps

and other products which are packed in bright attractive

colors as used by ordinary household consumers. It has

also observed that the labeling of the product shows that it

is intended for preoperative use by the surgeon and his

team or on the patient. The Tribunal after referring to the

Explanatory Notes under heading 30.04 of the Harmonized

System of Nomenclature relating to medicament, which

6

covers Povidone Iodine as Polyvinyl Povidone Iodine and, the

test laid down for classification of the product as

medicament: has concluded that the product is purchased

primarily for its therapeutic or prophylactic qualities and

not for its qualities as organic surface active preparation. In

conclusion, the Tribunal, while allowing the appeal, has

held that the product in question is, primarily intended and

also actually, used for its antiseptic properties, therefore, it

is classifiable as medicament under Chapter 30 of the

Schedule to the Act. It is the correctness or otherwise of the

findings and conclusions reached by the Tribunal is the

subject matter of these appeals before us.

9. We have heard Shri R.P. Bhatt, learned senior counsel

appearing for the Revenue and Shri Ajay Aggarwal, learned

counsel appearing for the Assessee. Both the learned

counsel have dealt with the matter in detail and have also

relied upon some of the decisions of this Court to buttress

their submissions.

10. Shri R.P. Bhatt, learned senior counsel for revenue

would submit that the product in dispute, namely; Povidone

7

Iodine Solution or its patent and proprietary equivalent

Wokadine surgical scrub, contains only 80 kg of Povidone

Iodine and 250 kg of Neutronix in 1000 litres of

demineralised water and is essentially used as a medicated

detergent. He would contend that the said product

predominantly contain surface active agents which are

primarily used as a medicated cleaning agent for removal of

dirt, bacteria, fungi etc. In this regard, he would further

submit that the said product is admittedly used as an

antiseptic agent for washing hands of surgeons and is also

applied on the skin of the patients before operation. He

would further contend that the said product is not a

medicament in terms of Chapter Note 2(i) of the Tariff Act as

it neither has "Prophylactic" nor "Therapeutic" usage. He

would contend that in order to qualify as a medicament, the

goods must be capable of curing or preventing some disease

or ailment. Therefore the said products cannot be classified

under Chapter Heading 3003 of Tariff Act.

11. Shri Bhatt would further submit that Chapter Note 1(e)

of Chapter 30 clearly excludes soap or other products of

Chapter 34, containing added medicament, from their

8

classification under Chapter 30. He would, therefore,

submit that the product is more appropriately classifiable

under the Chapter 3402 as an organic surface active

agent/preparation, or cleansing preparation, irrespective of

the fact that it contains certain percentage of medicaments.

In other words, he would contend that even if said products

have added prophylactic effectiveness, they would be

considered as cleansing agent and not medicaments for the

purpose of classification in view of their primary and

essential use which is cleansing and their prophylactic or

therapeutic quality, by virtue of added medicament, is

secondary in nature. He has placed reliance on some

decisions of this Court in support of his submission that it

is the primary functional properties and composition of the

goods that would decide its classification under particular

Chapter. We will refer to the decisions on which reliance is

placed by learned counsel at an appropriate time.

12. Shri Ajay Aggarwal, learned counsel for the assessee,

has meticulously taken us through the judgment of the

Tribunal and supported its reasoning. He contended that

the revenue in their show cause notices has admitted that

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the products in issue are antiseptic. He further submits that

the products are medicament in which some carriers are

added and therefore, it will fall under Chapter Sub-heading

3003 and not under Chapter 34.

13. In order to resolve the controversy that is raised before

us, we need to notice first the entries which the revenue and

the assessee relies upon to drive home their point of view.

The Tariff Items under Chapter sub-heading 3003 and

chapter sub-heading 3402.90, at the relevant time, are

extracted. The same reads as under:

Heading Sub- Description of goods Rate of

No. heading duty

No.

Medicaments (including

30.03 veterinary medicaments)

Patent or proprietary

medicaments, other than those

medicaments which are

3003.10 exclusively Ayurvedic, Unani, 15%

Siddha, Homeopathic or Bio-

chemic.

Medicaments (other than patent

or proprietary) other than those

3003.20 which exclusively used in 8%

Ayurvedic, Unani, Siddha,

Homeopathic or Bio-chemic

10

systems Medicaments, including

those in Ayurvedic, Unani,

Siddha, Homeopathic or Bio-

chemic systems.

Organic Surface active agents

(other than soap): surface-active

34.02 preparations, washing

preparations (including auxiliary

washing preparations and

cleaning preparations, whether or

not containing soap.

3402.90 Other

18%

14. The chapter note 2 (i) of Chapter 30 to the schedule of

Tariff Act pertaining to pharmaceutical products, define the

meaning of the expression "medicament". It is as under :

Medicament" means goods (other than foods or

beverages such as dietetic, diabetic or fortified 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 uses put up in

measured doses or in packings for retail sale or for use in

hospitals.

11 15. Chapter note makes it clear that the products,

comprising two or more constituents which have been

compounded together either for therapeutic or prophylactic

uses, would fall within the meaning of the expression

Medicaments. In the present case, it is not in dispute that

along with the medicament, namely; Povidone Iodine, the

assessee while manufacturing the products in question uses

three other constituents, namely; Neutronix, Superamide

and Sodium Hydroxide as a preservative.

16. It is also relevant to explore the meaning of the word

`prophylactic' in medical parlance as well, in order to resolve

the controversy before us. The word `prophylactic' derives

from Greek word `prophylaktikos' which means "to take

precautions against" or "to keep guard before". Dorland's

Medical Dictionary 1364 (28th ed. 1994) defines

"prophylactic" as "an agent that tends to ward off disease".

Merriam-Webster's Medical Desk Dictionary 579 (1993)

defines it as "guarding from or preventing the spread or

occurrence of disease or infection"; Mosby's Dictionary 1284

(4th ed. 1994) defines it as a biologic, chemical, or

mechanical agent that prevents the spread of disease.

12 17. It is relevant to notice the composition, label and usage

of the products whose classification is in dispute before us.

The label of the products would stipulate its formula and

describe its usage. However, the labels of both the products

are identical. Therefore, we would consider `Povidone Iodine

Cleansing Solution USP' which is presented in a maroon

coloured bottle of 500ml capacity on which a label has been

pasted which read as thus:

Povidone Iodine Cleansing Solution USP

"Povidone Iodine Cleansing Solution USP to be used as a

surgical scrub.

Broad Spectrum topical microbicidal effective against

bacteria, fungi, protozoa, yeasts and viruses.

Formula:

Povidone-Iodine I.P. 7.5. w/v

(Available Iodine 0.75% w/v)

Phosphate Free"

Store in a cool place

For External use only

Usage:

1. For preoperative cleansing and degerming of surgeon's

and operating team's hands

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a) Wet hands and forearms with water. Pour about 5

ml of surgical scrub with the help of the `elbow

dispenser' on the palm and spread over both hands

and forearms scrubbing thoroughly over all areas for

about 5 minutes. Add little water to develop copious

suds. Rinse thoroughly under running water.

b) Complete the cleansing with another 5 ml of

surgical scrub in the same way.

2. For preoperative uses on Patients.

After the skin area is shaved, wet it with water. Apply

Povidone Iodine surgical scrub on the skin and scrub,

thoroughly for about 5 minutes. Rinse off by aid of

sterile gauze saturated with water. Now paint the skin

with Povidone-Iodine solution and allow to dry before

incision."

18. The composition of the product per 1000 litres has

been produced below:

S.No. Ingredients Quantity

1. Povidone Iodine IP 80.21 Kgs.

2. Neutronix S-60(Anionic 250 Kgs.

Detergent) (active content

58%)

3. Superamide L-9 (foaming 12 Kgs.

agent)

4. Sodium Hydroxide 1.46 Kgs

(Preservative)

5. Demineralised water Balance

quantity

14

19. The said product contains- Povidone Iodine: The 7.5%

w/v of Povidone Iodine provides 0.75% w/v of available

iodine which is functions as disinfectant. Neutronix: The

25% of composition of the product is Neutronix which is

Anionics and used as detergents, wetting, emulsifying and

dispersing agents. Further the content of Superamide is just

1.2% in the said product which serves as an excellent

booster and stabilizer, viscosity builder and detergent with

wetting and soil suspending properties.

20. The assessee has relied on various pharmacopeias to

throw light on the essential composition of Povidone Iodine

Solution including surface active agents and their respective

functions. It is relevant to refer to these pharmacopeias in

order to appreciate and analyze the functions of various

ingredients contained in a Povidone Iodine Solution.

21. According to the US Pharmacopeia, Povidone Iodine is

a complex of Iodine with Povidone. It contains not less than

9.0% and not more than 12.0% of available iodine

calculated on the dried basis. Povidone Iodine cleansing

solution is a solution of Povidone Iodine with one or more

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suitable surface active agents. It contains not less than 85%

and not more than 120% of the labelled amount of the

iodine. It may contain a small amount of alcohol. The only

difference between the two is that while the first product

has a suitable surface active agent, the second product does

not have surface active agent.

22. The Japan Pharmaceutical Reference notes that Iodine

Surgical Scrub is a disinfectant containing povidone-iodine

with a foaming agent and a surfactant - which exerts

disinfecting action by releasing iodine, which shows

disinfecting effect against broad range of micro-organisms

including bacteria, fungi and viruses.

23. Goodman & Gilman's book titled `The Pharmacological

Basis of Therapeutics' reads:

"The most widely used iodophor is povidone iodine, in which

the carrier molecule is povidone...... A standard surgical

scrub with a 10% solution (1% available iodine) will decrease

the usual cutaneous bacterial population by about 85%......

When the hands are contaminated by gram-negative

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bacteria, povidone-iodine is more effective scrubbing

disinfectant."

24. Remington's Pharmaceutical Sciences records that

Povidone Iodine USP is a virtually non-stinging, film

forming, water soluble iodine compound used as a topical

antiseptic that essentially retains the non-selective broad

range microbicidal activity of iodine. Povidone Iodine will

rapidly kill bacteria (both Gram positive and Gram negative

as well as antibiotic resistant organisms), fungi, viruses,

protozoa and yeasts, to cause a substantial reduction of the

microorganisms on the skin. Preoperatively, or as a post

surgical antiseptic scrub, its microbicidal action is fast

acting and is effective for a period of 6 to 8 hours. It is

further stated that povidone-iodine antiseptic preparations

are clinically indicated for the prevention and treatment of

surface infections as well as to degerm the skin prior to

injection and hyperalimentation procedures, for pre and

post operative scrubbing and washing of hospital operating

room personnel and for pre-operative skin preparation of

the patient of surgery.

17 25. In Martindale's The Extra Pharmacopoeia, states that

Povidone-Iodine is an iodophore which is used as a

disinfectant and antiseptic mainly for the treatment of

contaminated wounds and pre-operative preparation of the

skin and mucous membranes. It is stated that solutions of

Povidone-Iodine gradually release iodine to exert an effect

against bacteria, fungi, viruses, protozoa, cysts and spores.

26. In Satoskar and Bhandarkar's Pharmacology &

Pharmaco Therapeutics, it reads:

"Iodophors are developed by complexing iodine with

surfactants like non-ionic detergents. The detergents act

as solubilizers and carriers, combining detergent property

with anti-bacterial activity. They owe their germicidal

activity to the slowly released elemental iodine."

27. The expression "therapeutic" or "prophylactic" is not

defined under the tariff entry. Therefore, useful reference

can be made to the dictionary meaning to these expressions.

In fact the assessee, in his reply to the show cause notices

issued, had relied upon the meaning of the expression

"therapeutic" and "prophylactic" from Webster's New 20th

18

Century Dictionary, Chambers English Dictionary, Websters

New 20th Century Dictionary. In our view, reference to all

other dictionary meanings may not be necessary. We intend

to confine ourselves only to the aforesaid three dictionaries.

In that the meaning of the expression "therapeutic" and

"prophylactic" is stated as under:

"To prevent, to guard against it, before, in medicine,

preventive protecting against disease."; "Guarding

against disease, a preventive of disease; a condom;

preventive treatment against diseases." and; "Serving

to cure or heal, Curative concerned in discovering and

applying remedies for diseases."

28. Before we discuss the issue posed before us, it would

be useful to make reference to observation made by this

Court in the case of ICPA Health Products (P) Ltd. Vs.

Commissioner of Central Excise, Vadodara, (2004) 4 SCC

481, wherein this Court, after referring to the meaning of

the expression "prophylactic" from the Concise Oxford

Dictionary, 9th Edn., has noted that the expression

"prophylactic" means a medicament intended to prevent

diseases, a preventive medicine or course of action.

19 29. It is the specific case of the assessee before the

adjudicating authority that the products in question are

primarily used for external treatment of the human-beings

for the purpose of the prevention of the disease. This is not

disputed by the revenue, but their stand appears to be since

the products in question are primarily used as

detergents/cleansing preparation, they cannot be brought

under the definition of medicaments. As we have already

noticed, medicaments are products which can be used

either for therapeutic or prophylactic usage. Since the

product in question is basically and primarily used for the

prophylactic uses, in our view the Tribunal was justified in

coming to a conclusion that the adjudicating authority and

the first appellate authority were not right in classifying the

products under chapter sub-heading 3402.90 and,

therefore, had classified those products under chapter sub-

heading 3003.

30. There is no fixed test for classification of a taxable

commodity. This is probably the reason why the `common

parlance test' or the `commercial usage test' are the most

common [see A. Nagaraju Bors. v. State of A.P., 1994 Supp

20

(3) SCC 122]. Whether a particular article will fall within a

particular Tariff heading or not has to be decided on the

basis of the tangible material or evidence to determine how

such an article is understood in `common parlance' or in

`commercial world' or in `trade circle' or in its popular sense

meaning. It is they who are concerned with it and it is the

sense in which they understand it that constitutes the

definitive index of the legislative intention, when the statute

was enacted [see D.C.M. v. State of Rajasthan, (1980) 4 SCC

71]. One of the essential factors for determining whether a

product falls within Chapter 30 or not is whether the

product is understood as a pharmaceutical product in

common parlance [see CCE v. Shree Baidyanath Ayurved,

(2009) 12 SCC 413; Commissioner of Central Excise, Delhi

v. Ishaan Research Lab (P) Ltd. (2008) 13 SCC 349]. Further,

the quantity of medicament used in a particular product will

also not be a relevant factor for, normally, the extent of use

of medicinal ingredients is very low because a larger use

may be harmful for the human body. [Puma Ayurvedic

Herbal (P) Ltd. v. CEE, Nagpur (2006) 3 SCC 266; State of

Goa v. Colfoax Laboratories (2004) 9 SCC 83 ; B.P.L

Pharmaceuticals v. CCE, 1995 Supp (3) SCC1] 21

31. However, there cannot be a static parameter for the

correct classification of a commodity. This Court in the case

of Indian Aluminium Cables Ltd. v. Union of India, (1985) 3

SCC 284, has culled out this principle in the following

words:

"13. To sum up the true position, the process of

manufacture of a product and the end use to which it is

put, cannot necessarily be determinative of the

classification of that product under a fiscal schedule like

the Central Excise Tariff. What is more important is

whether the broad description of the article fits in with

the expression used in the Tariff..."

32. Moreover, the functional utility and predominant or

primary usage of the commodity which is being classified

must be taken into account, apart from the understanding

in common parlance [see O.K. Play (India) Ltd. v. CCE,

(2005) 2 SCC 460; Alpine Industries v. CEE, New Delhi

(1995) Supp. (3) SCC 1; Sujanil Chemo Industries v. CEE &

Customs (2005) 4 SCC 189; ICPA Health Products (P) Ltd v.

CEE (2004) 4 SCC 481; Puma Ayurvedic Herbal (Supra);

Ishaan Research Lab (P) Ltd.(Supra) ; CCE v. Uni Products

India Ltd., (2009) 9 SCC 295].

22 33. A commodity cannot be classified in a residuary entry,

in the presence of a specific entry, even if such specific

entry requires the product to be understood in the technical

sense [see Akbar Badrudin v. Collector of Customs, (1990) 2

SCC 203; Commissioner of Customs v. G.C. Jain, (2011) 12

SCC 713]. A residuary entry can be taken refuge of only in

the absence of a specific entry; that is to say, the latter will

always prevail over the former [see CCE v. Jayant Oil Mills,

(1989) 3 SCC 343; HPL Chemicals v. CCE, (2006) 5 SCC

208; Western India Plywoods v. Collector of Customs, (2005)

12 SCC 731; CCE v. Carrier Aircon, (2006) 5 SCC 596]. In

CCE v. Carrier Aircon, (2006) 5 SCC 596, this Court held:

"14... There are a number of factors which have to be taken

into consideration for determining the classification of a

product. For the purposes of classification, the relevant

factors inter alia are statutory fiscal entry, the basic

character, function and use of the goods. When a commodity

falls within a tariff entry by virtue of the purpose for which it

is put to (sic. produced), the end use to which the product is

put to, cannot determine the classification of that product."

23 34. In our view, as we have already stated, the combined

factor that requires to be taken note of for the purpose of

the classification of the goods are the composition, the

product literature, the label, the character of the product

and the user to which the product is put. However, the

miniscule quantity of the prophylactic ingredient is not a

relevant factor. In the instant case, it is not in dispute that

this is used by the surgeons for the purpose of cleaning or

degerming their hands and scrubbing the surface of the

skin of the patient before that portion is operated upon. The

purpose is to prevent the infection or disease. Therefore, the

product in question can be safely classified as a

"medicament" which would fall under chapter sub-heading

3003 which is a specific entry and not under chapter sub-

heading 3402.90 which is a residuary entry.

35. The learned senior counsel for the revenue has placed

reliance on several decisions of this Court in support of his

argument that the products requires to be classified as

medicament only when they are intended or meant to cure a

disease or prevent the occurrence of disease. He further

24

submits that the disease can only be prevented when there

are some symptoms of disease. We intend to refer to those

decisions relied by learned senior counsel Shri Bhatt to

sustain the submissions made before the Court.

36. In B.P.L. Pharmaceuticals Ltd. v. CCE, (Supra), the

issue before this Court was regarding the classification of

the "Selenium Sulfide Lotion USP" manufactured and sold

by assessee under the brand name "Selsun shampoo".

According to the manufacturers this shampoo was a

medicated shampoo containing 2.5% Selenium Sulfide' w/v

as the only active ingredient which was meant to treat a

disease of the hair, namely; dandruff, and the rest of the

ingredients of the shampoo merely serve the purpose of a

bare medium. The revenue contended that the product

contains 2.5% w/v of Selenium Sulfide which is only of a

subsidiary curative or prophylactic value and therefore,

notwithstanding the product having a medicinal value will

fall under Chapter 33. This Court held that having regard to

the preparation, label, literature, character, common and

commercial parlance, the product was liable to be classified

as a medicament under Chapter sub-heading 3003.19. This

25

decision would not assist the revenue because this Court

held after considering various factors that selsun shampoo

is a medicament as it has therapeutic property to treat

dandruff unlike ordinary shampoo which could be of

common use by common people.

37. In Alpine Industries v. CCE, New Delhi (Supra), the

issue which arose for the consideration of this Court was

whether the product `Lip salve' is classifiable as a

medicament under Chapter Sub- Heading 30.03 or as

`preparation for care of skin' under Chapter Sub-heading

33.04. The stand of the assessee was that the product in

question was supplied exclusively to the military for use

while serving at high altitude. They claimed, by relying on

various literatures based on the composition of the product

that it was used as "medicament" and therefore, sought

classification under Chapter Sub- Heading 30.03. The stand

of the revenue was that it was used as "a preparation for

care of skin" to protect the skin on the lips against damage

by natural factors. This Court after considering the various

medical and pharmaceutical literatures held that the

Entries are not to be understood in their scientific or

26

technical sense, but by their popular meaning for the

purpose of interpretation. This court had observed that for

the purpose of classification, the commercial parlance

theory has to be applied and the chemical ingredients of the

product are not decisive. This Court after considering the

nature of the product and the use to which it is put had

observed that the `Lip salve' is used for "care of skin" and

not "cure of skin" and just because it has some curative

effect, its primary use is not curative, therefore it is not

medicament and also needs no prescription from a doctor.

This Court also held that it is neither prescribed by any

doctor nor obtainable from the chemist or pharmaceutical

shops in the market. This decision would not assist revenue

as this Court had arrived at a conclusion that the product is

not medicament but cosmetic after considering the

commercial parlance test and primary user of the product.

38. In ICPA Health Products (P) Ltd. v. CCE (Supra), this

Court has considered the issue of classification of surgical

scrubs, namely' Hexiprep, Hexiscrub (Surgiscrub) and

Hexiaque, manufactured by the assessee which was used as

a skin disinfectant to paint the skin before surgery and as a

27

wound disinfectant. It was admitted that Hexiprep is used

to paint the skin as required to disinfect the skin before

surgery. Hexiaque is used as a skin disinfectant to paint the

skin before surgery and as a wound, abrasions and minor

cuts disinfectant. Hexiscrub is used on hands and forearms

of surgeons for rapid hand disinfection prior to surgery. The

assessee claimed the classification of these products as

medicament under Chapter sub-heading 3003.10. Whereas,

the revenue contended that these products should be

classified as disinfectants under Chapter sub-heading

38.08. This Court had considered the report of the Chemical

examiner who opined that the products therein contained

`chlorhexidine gluconate solution BP' which had therapeutic

properties. However, he also opined that they were used as

disinfectant, therefore should be classified under Chapter

sub-heading 38.08. This Court after considering the label

and usage of products therein and dictionary meaning of

the word `prophylactic' had observed that the products

therein were used to disinfect the skin prior to surgery, to

clean the wound and minor cuts, and therefore, they have

prophylactic usage and classifiable under Chapter sub-

heading 3003.10.

28 39. In State of Goa v. Colfax Laboratories (Supra), the issue

before this Court was that whether the After Shave Lotion

(ASL) known as "Old Spice" and "Blue Stratos" are

classifiable as toilet preparations or medical preparations.

The assessee relying on various pharmacopoeia took the

stand that the product was "medicinal preparation" due to

the high percentage of alcohol content (above 60%). The

revenue contended that the use of after shave lotion was in

the form of "toilet preparations" and not "medicinal

preparation". The revenue also pointed that the assessee

had obtained the license for manufacture of ASL as a

cosmetic product and not as a medicinal product. This

Court while rejecting the assessee's contention held that the

high composition of alcohol in the product is not a relevant

factor for ASL to be considered a medicament. This Court

further observed that in order to come within the ambit of

"medicinal preparations", the article must be used for the

purpose of either curing or mitigating the disease after its

symptoms have appeared or in prevention of any disease

and therefore, on a plain interpretation ASL cannot be

considered to be within the ambit of "medicinal

29

preparation". Thus, in that case, this Court did not rely on

the composition of the product but relied on the principal

use and the common understanding of the product in the

market as the test for classification, in other words, the

classification of commodity does not depend on the

incidental character that the commodity takes but on its

primary character.

40. In CCE, Nagpur v. Vicco Laboratories, (2005) 4 SCC 17,

the point in consideration before this Court was that

whether the products, namely; Turmeric skin cream,

vajradanti toothpaste and tooth powder manufactured by

the assessee would be classifiable as Pharmaceutical

products under Chapter 30 or cosmetics under Chapter 33

of the Tariff Act. In that case, the assessee's products were

classifiable as pharmaceutical products before and after the

enactment of the Tariff Act. However, the revenue issued

show cause notices on the basis of the decision of this Court

in Shree Baidyanath, (1996) 9 SCC 402 alleging that the

products are understood as cosmetics in common parlance.

The revenue further contended before this Court that the

product was classifiable under Chapter 33 as a cosmetic as

30

there was no need for a medical practitioner's prescription

and the same was sold in general/departmental store. The

assessee took the stand that products were classifiable

under Chapter 30 as being pharmaceutical product. This

Court held that mere decision of a court of law without more

cannot be a justification enough for changing the

classification without a change in the nature of a product or

a change in the use of the product, or a fresh interpretation

of the tariff heading by such decision. This Court has held

that the Show cause notices having issued on the

misapprehension of the tests laid down in Shree Baidyanath

cannot be sustained, even though, the adjudicating

authority had found from the market survey that the

products are understood as cosmetics in common parlance.

This Court also held that the product cannot be treated as

cosmetic only because it was not sold by chemists or under

doctor's prescription. We are afraid that decision would

assist the revenue as the show cause notices in that case

were issued on the misapprehension of the test laid down in

the Shree Baidyanath and this Court further observed that

the decision in Shree Baidyanath was based on its peculiar

facts.

31 41. In Sujanil Chemo Industries v. CCE & Customs (Supra),

the question of classification of the product "licel",

manufactured by the assessee, was raised before this Court.

The assessee claimed, on the basis of the reports of

chemical examiners and the Department of Dermatology

and Venereology, that the product is an insecticide and is

classifiable under Chapter Sub-heading 3808.10 whereas

the Department contended that the product is classifiable

as medicament under Chapter Sub-heading 3003.10. This

Court after referring to Chapter Note 1(d) of Chapter 38

which excludes "medicaments under Heading 30.03 or

30.04" from its ambit and considering the definition of

`medicament' in terms of Chapter Heading 2(i) of Chapter

30, had observed that in normal parlance, a product may be

considered to be an insecticide but if that product has any

therapeutic and prophylactic use then for purposes of

classification that product would fall under Chapter 30

instead of Chapter 38. This Court observed that Licel cures

the infection or infestation of lice in human hair which is a

disease; therefore, it is thus therapeutic. This Court further

observed that Licel is also prophylactic inasmuch as it

32

prevents disease which will follow from infestation of lice.

This Court referring to its earlier decision in ICPA Health

Products (P) Ltd. v. CCE (Supra) has concluded that this

product for its therapeutic and prophylactic usages would

be classified as medicament under Chapter Sub-heading

3003.10. We are of the opinion that decision would not

come to rescue of the revenue as this Court in that decision

has clearly observed that the licel prevents as well as cures

the infection or infestation of the lice.

42. In Puma Ayurvedic Herbal (P) Ltd. v. Commissioner of

Central Excise, Nagpur (Supra), the issue before this Court

was that whether the ayurvedic goods manufactured by the

assessee are classifiable under the Central Excise Tariff Act,

1985 as cosmetics under Chapter 33 or as medicaments

under Chapter 30. The assessee contended that their

products are manufactured as per the Ayurveda

pharmacopoeia and other text books and have curative,

therapeutic or prophylactic value which are meant to give

relief in body ailments and they are not items of cosmetics.

The assessee further relied on the twin test: Whether the

product is used as medicament in common parlance; and

whether the ingredients used in the product are mentioned

33

in the authoritative ayurvedic textbooks. The assessee

further contended that the use of the product by the

customers should be taken into account for determining the

classification of products as these as the products which

have special and distinct use for treating a particular

ailment and are not items of common use. The revenue

argued that even if a product had some curative or

prophylactic value, it will still be cosmetic on the basis of

Note 2 of Chapter 33 of the Central Excise Tariff Act which

excludes cosmetics and toilet preparation having subsidiary

curative and prophylactic value. This Court while

appreciating the assessee's contention observed that

revenue has miserably failed to prove that the products in

dispute are not medicament and not understood as

medicament by the common man. This Court had upheld

the twin test for classification of ayurvedic products relied

by the assessee and observed that the primary role or use of

the product has to be taken into account for the purpose of

classification, even though, it may happen that while

treating a particular medical problem, after the problem is

cured, the appearance of the person concerned may

improve. This Court further held that it is not necessary for

34

the medicament to be sold only under doctor's prescription

and its availability across the counter in shops is not

relevant for its classification as medicament. This Court

held that, therefore, the fact that use of medicinal element

in a product was minimal does not detract from it being

classified as a medicament. This Court concluded that the

products in dispute are medicinal products which are

intended to treat certain medical conditions of the human

body and improvement in appearance is subsidiary,

therefore, are liable to be classified as medicaments falling

under Chapter 30. This case would not assist revenue as

this Court had applied a primary user test of the products

in question which has certain medicinal ingredient.

43. In Commissioner of Central Excise, Delhi v. Ishaan

Research Lab (P) Ltd. (Supra), the issue before this Court

was whether the products manufactured by the assessee

would fall under Sub-Heading 3003.30 as medicament or

under Chapter 33 as cosmetics. The assessee contended

that each of the products was having ayurvedic medicinal

herbs in it and even the labels on these products claim

specifically the medicinal properties of the product. The

assessee further urged that even if the user of product leads

35

to improvement in appearance of a person that by itself

cannot bring it into the category of "cosmetics" if otherwise

the product is having a medicinal value and is marketed as

such. According to the revenue, all these products were

understood to be the "cosmetics" in common parlance and

not actually the "ayurvedic medicines" for various reasons,

the said products should have been held to be covered

under Chapter 33. This Court after inspecting the labels of

the product has held that the assessee had claimed in each

of the label regarding its medicinal properties and, the

product is not a cosmetic. This Court also observed that the

common parlance test is not "be all and end all", and held

that the miniscule percentage used is also not a deciding

factor. This Court concluded that the products in question

are medicinal products and, therefore, are covered by

Chapter 30 and not under Chapter 33. That case would not

assist revenue as this Court after taking into account the

labels on the products observed that these products have

medicinal ingredients and are marketed as ayurvedic

medicines not cosmetics, however it incidentally improve the

appearance, and also held that the common parlance test

by itself is not conclusive.

36 44. In view of the above, we reject the Revenue's appeals

and confirm the order passed by the Tribunal with no order

as to costs.

Ordered accordingly.

............................J.

(H.L. DATTU)

............................J.

(ANIL R. DAVE)

NEW DELHI;

FEBRUARY 22, 2012

37