Section 120 in The Drugs and Cosmetics Rules, 1945
120.
Notwithstanding anything contained in the last preceding rule, in any case where-(a)a substance is required in any emergency by a registered medical practitioner, but the licensee has not filled containers in stock, or(b)a substance which, in the opinion of the licensing authority, is so unstable in solution that the delay occasioned by the completing of the sterility test on filled containers would render its issue in active form impossible, the licensee may issue the substance from a batch which has already passed the tests for sterility and freedom from abnormal toxicity, without completing the sterility test on the filled containers, provided that he complies with the following conditions:-(i)the licensee shall before the issue take samples in the required proportions from the containers into which the batch is filled, and after the required inoculation and incubation shall examine the tubes every day for five days;(ii)if at any examination any growth is visible in any of the tubes, he shall immediately notify the licensing authority;(iii)he shall keep available for inspection a record of all issues made under this rule containing such particulars of the circumstances in which the issue is made as the licensing authority may require.
