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In injectable patent or proprietary medicines, the test for freedom from toxicity, shall be performed as described in the Indian Pharmacopoeia. Dose selected shall be indicated in the protocol but the dose shall not be less than five times the human dose based on body weight of 60 kg. human being.] Drugs and Cosmetics Rules 1945 581 Drugs and Cosmetics Rules, 1945 Vitamin Unit Patent or proprietary Patent or proprietary Patent or proprietary medicines containing Medicines containing medicines containing vitamins for paediatric use. Vitamins for prophylactic vitamins for therapeutic Use. (in single dose or in two divided doses) per daily dose For adults For infants less than For children above one one year. year up to adults 1 2 3 4 5 6 Vitamin A. I.U Not less than 1600 and not more than 2,500 Not less than 5000 and not more than 10,000 Not less than 750 and not Not less than 1500 and more more than 3,000 than 5,000 Vitamin D. I.U Not less than 100 and not more than 200. Not less than 400 and not more than 1,000 Not less than 200 and not Not less than 100 and more than more than 400 400 Vitamin B1 mg. Not less than 1 and not more than 2 Not less than 4.5 and not more than 10 Not less than 0.5 and more Not less than 1 and not more than 1 than 4.5 Vitamin B2 mg Not less than 1 and not more than 3 Not less than 5 and not more than 10 Not less than 0.5 and not Not less than 1 and not more more than 1.5 than 5. Vitamin B6 mg Not less than 0.5 and not more than 1.5 Not less than 1.5 and not more than 3 Not less than 0.5 and not Not less than 1 and not more more than 1.5 than 3 Niacinamide mg Not less than 15 and not more than 26 Not less than 45 and not more than 100 Not less than 5 and not more Not less than 10 and not more than 15 than 40. d-Pantothenic mg Not less than 1 and not more Not less than 5 and not more Not less than 1 and not more Not less than 2.5 and not more acid or its salts than 5 than 50 than 3 than 10 and panthenol. Folic acid mg. Not less than 50 and not more Not less than 1000 and not more Not less than 25 and not Not less than 100 and not more than 300 than 1500 more than 100 than 500 Drugs and Cosmetics Rules 1945 582 Drugs and Cosmetics Rules, 1945 1 2 3 4 5 6 Vitamin B12 mcg Not less than 0.5 and not more Not less than 5 and not more Not less than 1 and not more Not less than 1 and not more than 1 than 15 than 3 than 5 Vitamin C mg Not less than 25 and not more than 50 Not less than 75 and not more than 150 Not less than 20 and not more than 40 Not less than 30 and not more than 80 Vitamin E I.U Not less than 5 and not more than 10 Not less than 15 and not more than 25 Not less than 2.5 and not more than 10 Not less than 5 and not more than 20. Notes: (1) Patent or proprietary medicines containing vitamins intended for prophylactic, therapeutic or paediatric use shall bear on the label the words ―For Prophylactic Use‖ ― For Therapeutic Use,‖ or ―For Paediatric Use‖ as the case may be. In the case of paediatric preparations the age of the infant or the child for whose use it is intended, shall be given in addition to the particulars required to be given under these rules. (2)The above standards shall not apply to any preparation containing a single vitamin only and also to any preparation containing vitamins intended for parenteral use. Provided, however, that in the case of patent or proprietary medicines containing vitamins which are intended for the treatment of certain specific conditions or diseases, the Licensing Authority specified in clause (b) of rule 21, may permit the addition of vitamins therein in relaxation of the limits specified above, if satisfactory evidence is produced in justification of such relaxation.