Customs, Excise and Gold Tribunal - Bangalore
Sarvotham Care Limited vs Commissioner Of Central Excise on 18 January, 2005
Equivalent citations: 2005(100)ECC376, 2005(185)ELT274(TRI-BANG)
ORDER S.L. Peeran, Member (J)
1. The appellants are contesting the classification of their product Nizral Shampoo 2% as Cosmetics falling under CSH 3305.99 of the Central Excise Tariff. It is the contention of the appellant that the item is rightly classifiable as a Patent or Proprietary Medicament falling under CSH 3003.10 as the time contains 2% synthetic broad spectrum antifungal agent Ketoconazole. The pamphlet which is issued by the appellant states that one ml contains 20 mg Ketoconazole. It is stated that it is for the use only of a Registered Medical Practitioner for a hospital or a laboratory. The details of the label/leaflet of the product is reproduced below:
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory Ketoconazole Shampoo 2% Nizral Shampoo 2% For topical use only Description Nizral Shampoo 2% contains the synthetic broad spectrum antifungal agent Ketoconazole. One ml contains 20 mg Ketoconazole.
Properties Pharmacodynamics Ketoconazole, a synthetic imidazole dioxolane derivative has a potent antifungal activity against dermatophytes, such as Trichophyton sp. Epidermophyton sp. Microsporum sp. and yeasts, such as Candida sp. and Malassezia furfur (Pityrosporumovale). Ketoconazole shampoo rapidly relieves scaling and pruritus, which are usually associated with pityriasis versicolor seborrhoeic dermatitis and pityriasis capitis (dandruff).
Pharmacokinetics Percutaneous absorption of Ketoconazole shampoo is negligible since blood levels cannot be detected, even after chronic use. Systemic effects, therefore, are not expected.
Indications Treatment and prophylaxis of infections in which the yeast pityrosporum is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).
Contra-indications Known hypersensitivity to Ketoconazole or the excipient.
Warnings and Precautions To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroid it is recommended to continue applying the topical corticosteroid together with Nizral shampoo 2% and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks. Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding and this has also been reported although rarely, with the use of Nizral Shampoo 2%.
Pregnancy and Lactation Since Ketoconazole is not absorbed through he skin after topical application, pregnancy and lactation are not a centra-indication for the use of Nizral Shampoo 2%.
Dosage and Administration The affected areas of the skin or the hair should be washed with Nizral Shampoo 2% which should be left for 3 to 5 minutes before rinsing.
Treatment:
-Pityriasis versicolor: once daily for maximum 5 days.
-Seborrhoeic dermatitis and pityriasis capitis; twice weekly for 2 to 4 weeks. Prophylaxis:
-Pityriasis versicolor: once daily for maximum 3 days during a single treatment course before the summer.
-Seborrhoeic dermatitis and pityriasis capitis: once every one or two weeks. Adverse reactions Topical treatment with Nizral Shampoo 2% is generally well tolerated. As with other Shampoos, a local burning sensation, itching, irritation and oily/dry hair may occur, but are rare, during the period of use of Nizral Shampoo 2%. In rare instances, mainly in patients with chemically damaged hair or grey hair, a discolouration of the hair has been observed. Overdosage Not expected as Nizral Shampoo 2% is intended for external use only. In the event of accident ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be performed. How supplied Nizral Shampoo 2% is supplied in a
-50 ml bottle 50 ml sachet Storage conditions Protect from heat and light.
Keep out of reach of children.
Patient information KETOCONAZOLE SHAMPOO 2% Nizral Shampoo 2% You have been advised by your doctor to use this shampoo to treat dandruff. This leaflet gives you some information that you should keep in mind while using Nizral Shampoo. It also gives some background information on dandruff, which is important for you to deal with it. Please read this leaflet carefully to get the best results from this treatment. Remember that it cannot answer all your questions and that you should check with your doctor for any further information you may require.
What is dandruff?
Dandruff is a disorder affecting the hairy scalp. Hence, no dandruff can exist without hair. It is characterized by two major symptoms -- scaling and itching. Scaling takes the form of white, transparent flakes of varying size, depending on the stage of the disease. Particularly on dark clothes, the flakes are conspicuous, which can be rather embarrassing to the person involved. The itching can be so intense that - mostly unconsciously - one starts to scratch one's head as a result of which even more flakes fall on the clothing. Some people have been suffering from persistent dandruff for years. In others, it flares up periodically. The incidence seems to increase during the winter months. It would be a mistake to assume that dandruff is synonymous with poor or inadequate hygiene. Even people excessively concerned with personal hygiene may be affected by dandruff.
What triggers dandruff?
Medical science has recently succeeded in pinpointing the cause of dandruff. The scoundrel is a single celled organism, a kind of fungus with the scientific name Pityrosporum ovale. This fungus is always present on everyone's skin invisible to the naked eye, but it is perfectly harmless under normal conditions. In individuals, with dandruff, abnormal high numbers of the Pityrosporum fungus are found on the scalp sometimes 10 to 20 times the normal quantity. It then triggers an infection like process (inflammation) round the hair roots, with scaling and itching as the direct result.
How can dandruff be treated?
Dandruff does not disappear spontaneously on the contrary, the longer it is left untreated, the worse the scaling and itching become. A new medicine that is known for its exceptional activity against the Pityrosporum has now become available as Nizral Shampoo 2% How to apply Nizral Shampoo 2% to get the best results?
There are two phases in the treatment of dandruff with Nizral Shampoo 2%.
Clean up Phase
-Twice weekly for 2-4 weeks.
1. Wet the hair with a small quantity of water.
2. Apply a small quantity of shampoo to the scalp and work up a lather. Usage of a small quantity of water ensures a high concentration of medication in the lather.
3. Massage the lather into all parts of the scalp.
4. Leave for 5 minutes and then rinse thoroughly.
Prophylactic phase
-Once a week As soon as the desired surest i.e. elimination of dandruff has been achieved, it can be stablized by one routine weekly washing with the shampoo. This will prevent dandruff from reappearing. Normal shampoos may be used on other occasions.
2. The contention of the appellant is that the finding recorded by the Commissioner that the item is being treated as a Shampoo is not correct as the product which is marketed as Shampoo without the active ingredient Ketoconazole has been classified under Chapter 33 as Cosmetics and they are not contesting this classification. But it is only this product which contains Ketoconazole on 20 mg in one ml which is not sold across the counter by the shop-keeper as Cosmetics but sold only by medical shop on the prescription by a Registered Medical Practitioner or a Hospital or a Laboratory. They further relied on the following evidence in support of their case before Commissioner.
(i) Product literature
(ii) Remington Pharmaceutical Sciences 1990
(iii) Martindale Extra Pharmacopeia
(iv) Indian Pharmacopeia 1996
(v) The United States Pharmacopeia, The National Formulary 1995
(vi) Article of Mycoses
(vii) Ketoconazole in Seborrhoeic Dermatitis & Dandruff -- A Review
(viii) Article by Johan MacGrath & G.M. Murphy - The control of Seborrhoeic Dermatitis and Dandruff by Antipityrosporal Drugs
(ix) Article by H. Dobrev and L. Zissova - Effect of Ketoconazole 2% Shampoo on scalp Sebum level in Patients with Seborrhoeic Dermatitis,
(x) Article by Danby et al - Ketoconazole 2% versus Selenium Sulfide 2.5% Shampoo
(xi) Affidavits
(xii) Order dated 10.4.1996 passed by Assistant Commissioner of Central Excise, Pune
(xiii) Order dated 31.3.1997 passed by Assistant Commissioner of Central Excise, Bhandu Division, Mumbai-III They further claimed Ketoconazole 2% is therapeutic dosage and the effectiveness of this ingredient is its main function but not subsidiary. They also claim it is nowhere mentioned in the product literate that it is a preparation for use in hair. The further claim that the usage of shampoo mentioned in the patient information during the two phases in the treatment of dandruff, twice weekly for 2-4 weeks during the clean up phase and once a week during prophylactic phase also goes to prove it is a medicine unlike other shampoos which can be used regularly without any restrictions. In view of the above, the appellants pray to classify the product under Chapter Sub-heading No. 3003.10 and to set aside the impugned order.
3. The manufacturing process as stated in para 6 of the Commissioner's order is reproduced below.
"DM Water, PEG 6000/PEG Distearate 6000 and Sodium Chloride and mixed and heated to high temperature in planetary mixer, Sodium Lauryl Either Sulphate (SLES)/Sodium Lauryl Ethyls/Galaxy LES, Cocodiethanolamide/Galaxy 123 are added on mixing and is cooled. Ketoconazole (Microfine) Lauryl Betaine/additive AG/Cocobetaine, Polysorbate 20/Tween 20 are charged to the mass. Erythrosine Sodium Colour/Erythrosine Supra HD are added to the batch, After addition of Kathan CG, Perfume ID 14112 are added and mixed well. PH of the batch is adjusted with either Hydrochloric Acid or Sodium Hydroxide. After testing in quality control department, shampoo is filled in plastic bottles and sealed with plugs and caps. The sealed bottles are labelled and cartooned with leaflet and then in white paper boards. The paper boards are finally packed in corrugated boxes."
4. The Commissioner (Appeals) had distinguished the Supreme Court judgment rendered in the case of B.P.L. Pharmaceuticals Ltd. v. CCE, Vadodara, 1995 (77) ELT 485 (SC) wherein 'Selsun', an anti-dandruff preparation containing 2.5% Selenium Sulfide was classified as a Drug under Sub-Heading 3003.19 of the CET. He has proceeded solely on the basis of the leaflet and the product literature, which contains details about the cause of dandruff and use of the item on the hair and scalp, which according to the appellants is for the purpose of curing the skin diseases. The Commissioner has negatived the same and has taken a view that the product is essentially a preparation for use on hair/scalp and not used as a medicine although it is not disputed that it is manufactured under a drug licence/permission granted by the Drug Controller of India and Food and Drug Administration and sold on prescription of a Registered Medical practitioner through a retail pharmacist only.
5. We have carefully considered the submissions made by the learned Counsel and the learned DR. We find from the extracted literature that the item comprises of 20 mg Ketoconazole in one ml and the pamphlet clearly indicates that it is for the use only of a Registered Medical Practitioner or a Hospital or a Laboratory. The pamphlet claims that the item is used for treatment and prophlaxis of infections in which the yeast pityrosporum is involved such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis(dandruff). The procedure for treatment and the adverse reactions on such treatment due to overdose is also stated in the pamphlet. The Apex court, in the case of Muller & Phipps (India) Ltd. v. CCE, 2004 (94) ECC 1 (SC) : 2004 (167) ELT 347 (SC) has clearly held that once the item has been manufactured under a Drug licence and the Department has treated the item as a Drug, it would not cease to be one notwithstanding the fact that new Tariff Act has come into force. The Apex Court again held in the case of CCE v. Pandit D.P. Sharma, 2003 (87) ECC 243 (SC) : 2003 (254) ELT 324 (SC) that once in the common parlance the item is treated as a medicament and manufactured under drug licence and the evidence is produced by the party with regard to the item being a medicament, then it should be treated as such and should not treat 'Himtaj Oil' as 'perfumed hair oil'. The Apex Court's ruling in the case of B.P.L. Pharmaceuticals Ltd. v. CCE, 1995 (77) ELT 485 has held that 'Selsun' and anti-dandruff preparation containing 2.5% selenium sulphide which is full therapeutic limit permissible as per pharmacopoeia and manufactured under Drug Licence and certified by Food and Drugs Administration as a medicine and the same is put up as a medicine to be used under Doctor's advise in accompanying literature and sold through chemist shops under doctor's prescription should be considered as a medicament under Sub-Heading 3003.19 of CE Act and not as a cosmetics. In the present case also, same evidence is relied which are identical to the facts of B.P.L. Pharmaceuticals Ltd. The item also acts as an anti-dandruff preparation with 2% Ketoconazole. The same is sold on doctor's prescription and by the chemists and understood as a medicine in common parlance as per the enormous literature and affidavit produced. Therefore, there was no necessity for the Commissioner to have distinguished this Apex Court judgment which applies on all fours to the facts of the present case. We also find that the judgment of the Apex Court rendered in the case of CCE v. Vicco Laboratories, 2005 (179) ELT 17 (SC) also applies to the facts of the case. In this case, the Apex Court has clearly noted that the common parlance test should be applied for determining whether a product is classificable as a pharmaceutical product under Chapter 30 of CET Act or as a cosmetics under Chapter 33 ibid as laid down by the Supreme Court in the case of Shree Baidyanath Ayurved Bhavan Ltd., 2002 (82) ECC 460 (SC) : 1996 (83) ELT 492 (SC). As there is enormous evidence produced by the appellants with regard to the use of Ketoconazole Shampoo for treatment of several disorders and diseases mentioned in the pamphlet and the same is sold by a chemist under a prescription issued by a Registered medical Practitioner or a Hospital or a Laboratory, therefore, the appeal is required to be allowed with consequential relief, if any.
6. Ordered accordingly.