Section 109(4) in The Drugs and Cosmetics Rules, 1945
(4)For the purpose of clause (a) of sub-rule (3), the date on which the manufacture of a batch is completed shall be-(a)in cases where a test for potency or toxicity is required, by these rules or not being so required, is accepted by the licensing authority as sufficient for the purpose of fixing the date of completion of manufacture, the date on which the substance was removed from cold storage after having been kept at a temperature not exceeding 5oC continuously for a period not exceeding two years from the time when the last test was completed;(b)in cases where no such test is required or accepted:-(i)if the substance is a serum obtained from a living animal, the earliest date on which any material contributing to the batch was removed from the animal;(ii)if the substance was obtained by the growth of organisms on artificial media, the earliest date on which growth was terminated in any of the material contributing to the batch:Provided that if a batch of the substance (including all material contributing to this batch) has for a period of not more than three years been kept in cold storage at a temperature not exceeding 5oC continuously from the earliest practicable date after that on which growth was terminated in the material, as the case may be, the date of removal from cold storage shall be treated as the date on which the manufacture of the batch is completed;(c)in all other cases, the date on which the substance is filled in the container.]
