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1971 Supreme(Mad) 612

Madras High Court
K. VEERASWAMI,RAGHAVAN
Union of India - Appellant
Versus
Hoechast Pharmaceuticals Ltd., Bombay - Respondent
Decided On : 09/09/1971

Advocates:
K. Parasaran and C. Rangasami Iyengar, for Appellant in O.S.A.34 of 1965 and for Respondents in W.Ps; S.K.L. Rattan, for Respondent in O.S.A.34 of 1965 and for Petitioners in W.Ps.

The classification of drugs under the Indian Customs Tariff depends on the presence of therapeutic ingredients and their effect, rather than the mere presence of an ingredient.

Headnote:

CUSTOMS DUTY - CLASSIFICATION OF DRUGS - TETRACYCLINE HYDROCHLORIDE INJECTIONS - WHETHER FALL WITHIN ENTRY 28(27) OR ENTRY 28-A OF THE INDIAN CUSTOMS TARIFF - INTERPRETATION OF 'THERAPEUTIC INGREDIENT' - LEGALITY OF LEVY - REMEDY FOR RECOVERY OF ILLEGAL LEVY.

Fact of the Case:

The Union of India appealed against a judgment of Sadasivam, J., which held that Tetracycline Hydrochloride injections imported by the respondent pharmaceutical company fell within Entry 28(27) of the Indian Customs Tariff and not Entry 28-A, and thus the excess duty collected by the Union was refundable.

Finding of the Court:

The court found that Tetracycline Hydrochloride injections, despite containing Ascorbic acid, did not have any therapeutic effect of Ascorbic acid and therefore fell within Entry 28(27), which specifically excluded drugs containing only one antibiotic and free from other therapeutic ingredients.

Issues: 1. Whether Tetracycline Hydrochloride injections containing Ascorbic acid fall within Entry 28(27) or Entry 28-A of the Indian Customs Tariff. 2. Whether the levy of excess duty on the respondent's drug was illegal and if so, the appropriate remedy for its recovery.

Ratio Decidendi: 1. The court interpreted 'therapeutic ingredient' in Entry 28(27) to mean an ingredient that has a therapeutic effect, not merely its presence as a component of an antibiotic. 2. The court held that Ascorbic acid in the respondent's drug was added for a buffer effect and not for therapeutic purposes, and therefore the drug fell within Entry 28(27).

Final Decision: The court dismissed the appeal and allowed the writ petitions filed by the respondent, upholding the refund of excess duty collected.

Judgement

VEERASWAMI, C.J.:- The Union of India, which was the defendant, appeals from a judgment of Sadasivam, J., for the plaintiff, a pharmaceutical company, which claimed a refund of Rupees 20,854-83 being, according to its case, the excess amount of duty illegally collected by the Union in respect of five consignments of Tetracycline Hydrochloride injections imported under the brand name "Hostacycline" manufactured by M/s. Parbworks Hoschat A.G. The Assistant Collector of Customs assessed the consignments to duty under Item 28-A of the Indian Customs Tariff. He took the view that inasmuch as the imported drug contained Ascorbic acid, which should be regarded as therapeutic ingredient within the meaning of Entry 28(27) it did not fall within the purview of that entry and therefore the charge should be made under Entry 28-A. The matter came before this court in the form of a writ petition filed by the respondent, but one of us sitting on the writ side considered that inasmuch as evidence would be necessary, the proper remedy would be by way of suit. That is how the suit out of which the appeal arises came to be instituted. The learned Judge at the trial took the view that though Tetracycline Hydrochloride of the respondent did contain Ascorbic acid of a certain percentage, it did not, in the light of the evidence of Dr. Sanjivi, have any therapeutic effect, and therefore, the proper classification of the drug would be under Entry 28(27) and not Entry 28-A. On that view, he decreed the suit. We may mention in passing that Sadasivam, J. also found that Ambramycin (Letetit), Achromysin (Lederle) Steclain (Squibb) and Tetradin (Pfizer) had been classified by the Bombay Customs as drugs falling within the purview of Entry 28(27) and that the classification of the respondent's drug Tetracycline Hydrochloride injections as falling within Entry 28-A was discriminatory.

2. Entry 28-A is Patent of proprietary medicines as defined in clause (d) of Section 3 of the Drugs Act, 1940 (XXIII of 1940) not containing spirit and not otherwise specified. "The nature of duty shown against this item is 'preferential revenue' and the standard rate of duty is 50 per cent ad valorem. Entry 28(27) relates to antibiotics such as streptomycine, gramicidein, tyroeidin and thryothricin and preparations, which contain only one antibiotic, and are free from other therapeutic ingredients, but not including penicillin in bulk and penicillin and its products specified in Item Nos.28(26) and 28(26-A). Patent and proprietary medicine, as defined in Section 3(d) of the Drugs Act 1940, means "a drug which is a remedy or prescription prepared for internal or external use of human beings or animals, and which is not for the time being recognised by the permanent Commission on Biological Standardisation of the World Health Organisation or in the latest edition of the British Pharmacopoeia or the British Pharmaceutical Codes or any other Pharmacopeia authorised in this behalf by the Central Government after consultation with the Board." Tetracycline Hydrochloride injection both intravenous and intramuscular, is an antibiotic, and this is not in dispute. As such, it will normally fall within Entry 28(27). The only question therefore is whether inasmuch as the respondent's Tetracycline Hydrochloride contained a percentage of Ascorbic acid, that fact, by itself, will take it out of Entry 28(27). The learned counsel for the appellant insists that Ascorbic acid being, a therapeutic ingredient which is part of the respondent's drug, it is necessarily excluded from Entry 28(27). But he is not sure whether even if it were so, it would automatically come within Entry 28-A. No investigation on that matter seems to have been made till now and it is not necessary, on the view we take to go into that.

3. Dr. Sanjivi, who gave evidence for the respondent at the trial, was definitely of the view that Tetracycline Hydrochloride. when administered to a patient, has no therapeutic effec


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