The Ministry of Health and Family Welfare has recently on 25th January, 2019 rolled the Drugs and Cosmetics (Third Amendment) Rules, 2019 (“Amendment Rules”) adding a new item in Schedule K of the Drugs and Cosmetics Rules, 1945. Schedule K consists of those drugs that are exempted from Chapter IV of the Drugs and Cosmetics Act, 1945 which deals with manufacture, sale and distribution of drugs and cosmetics.
In the Amendment Rules, sterile solutions intended for parenteral administration with 100 ml in one container of the finished dosage form for single use which is manufactured for the purpose of export only is the new item that has been added in Schedule K, after item number 37.
Source: Ministry of Health and Family Welfare
