Indian pharma companies now need to increasingly focus on stability studies to prove the safety of formulation till the end of the shelf life. The industry already has three regulations to adhere: Drugs & Cosmetic Rules, US FDA and WHO stability testing guidelines for API, finished drugs and the ICH norms on the same. The purpose of the stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. It also calls for storage conditions, retest periods and shelf life of the products, said B Kumar, deputy drugs controller, sub-zonal office, CDSCO, Bengaluru. In order to ensure that the drug formulations marketed in the country are stable till the end of the shelf life, it is necessary that stability studies should be brought under the condition of license for manufacturing drugs especially in Rule 71, 71-B & Rule 76, he adde...