1984 (6) TMI 226

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....are that the appellants are manufacturers of Ifimycin injection containing 'Chloramphenicol'. The composition of the product is stated to be :- Chloramphenicol I.P. 125 mg. Lignocaine Hydrochloride 10 mg. Prophylene Glycol USP q.s. Chlorocresol I.P. 0.1% The appellants claim that Chloramphenicol is the only active ingredient in the product, the other ingredients being merely pharmaceutical necessities which are therapeutically inert and do not interfere with the therapeutic and prophylactic activity of chloramphenicol. The product is used to cure diseases like typhoid and the curative effect is attributable to chloramphenicol. The appellants, therefore, claimed that the product was eligible for concessional assessment in term....

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.... Chloramphenicol can also be administered without lignocaine hydrochloride; the latter is only added as a pain reliever and local anaesthetic. Reliance was placed on a certificate issued by the Commissioner of Food & Drug Administration, Maharashtra State which supports the above contention. The Appellate Collector has given no reasons for ignoring or not considering the said certificate. That Lignocaine hydrochloride may have therapeutic value in other situations. (Cardiac irritability, ventricular arrhythmias following cardiac infection, during cardiac catheterisation, open heart surgery etc.) is not relevant in the present case. The Appellate Collector's order only amounts to confirmation of the order of the Assistant Collector which,....

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....ed 3rd May, 1969 shows that the added ingredient should be a diluent, disintegrating agent, moistening agent, lubricant, buffering agent, stabilizer or preservative or should be a pharmaceutical necessity similar to the aforesaid categories in order that the preparation containing the added ingredient may be eligible for the duty concession in the notification. Lignocaine hydrochloride which, in the subject chloramphenicol injection, acts as a local anaesthetic, does not belong to any of these or like categories. 8. The certificate by the Commissioner, Food & Drug Administration, Maharashtra State, (the certificate is not on record but has been reproduced in the Revision Application) is to the effect that the added ingredients serve....