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 Case Digest

Drugs and Cosmetics Act, 1940
Section 3(b)(i)(iii) and 18 - definition of 'drug'
Section 3(b)(i)(iii) and 18 - definition of 'drug'
Whether EC 350 (Vitamin E and Vitamin C Capsules) and Cecure (Multi - Vitamin Capsules) manufactured by the petitioner and sold in the market through medical shops as "Dietary Supplements" falls within the definition of "drug" requiring licence under the Drugs and Cosmetics Act, 1940? - held the definition of 'drug' in the Act the clearly specifies that all substances intended to be used for mitigation of prevention of any disease or disorder in human beings is a drug and further all substances intended for use as components of a drug including empty gelatin capsules is a drug - the two items of Vitamins are filled in empty gelatin capsules. So a combined reading of clauses (i) and (iii) of Section 3(b) would show that the two items, EC 350 and CECURE which are Vitamin E and Vitamin C and/or multi-vitamin tablets would fall within the definition of 'drugs' - as per Rule 43 of the Drugs and Cosmetics Rules drugs specified in Schedule D shall be exempted from the provisions of chapter III of the Act and of the Rules made thereunder to the extent and subject to the conditions specified therein. The items which are exempted under schedule D, item 5 reads "the following substances' which are used both as articles of food as well as drugs : (1) all and minerals - by virtue of the definition of 'drug' in the Act a substance which is swallowed for mitigation or prevention of disease in human beings or in animals is a medicine and a drug. The two products in question is not used by any person as a general dietary supplement. Vitamin deficiencies in human being may result in certain diseases in human beings. In such cases doctors prescribe these vitamin capsules of a particular dozage which is for mitigation or for prevention of such diseases. These vitamin capsules will squarely fall within the definition of 'drug' under the Act - two items 'EC-350' and 'CECURE' which are styled as 'dietary supplements' are 'drugs' within the definition of the said word in Section 3(b) of the Drugs and Cosmetics Act, 1940.
Cadila Pharmaceuticals Ltd. vs. State of Kerala and Others, KERALA HIGH COURTS, 2003 Drugs Cases 21


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