The Ministry of Health and Family Welfare has revised the Schedule ‘M’ on Good Manufacturing Practices appearing in Drugs and Cosmetics Rules, 1945 vide notification no.GSR 894(E) dated 11th December 2001.

The Association has submitted its observations/suggestions on the provisions of the revised schedule drawing authority’s attention to the clauses which need amendments, the clauses in which inadvertent contradictions were noticed and clauses on which guidelines/clarifications were required.

The Ministry of Health & Family Welfare has now extended the cut off date of revised Schedule M on Good Manufacturing Practices by one year i.e. up to 31.12.2004 and the provisions of the revised Schedule M will be made applicable with effect from 01.01.2005 in case of manufacturers licensed prior to 11.12.2001.