The undisputed facts are that the alleged drug was manufactured on 01.10.2004. On that date no standard was prescribed. On 06.10.2005 a notification came to be issued wherein for the first time a standard was prescribed by the Food and Drug Administration, Maharashtra State. The sample was collected on 03.06.2005. It was sent for analysis on 04.06.2005. The analyst prepared report on 08.09.2005.