ABSTRACT

As per the Drugs and Cosmetic Act, it is necessary to obtain drug manufacturing license for sale of Ayurvedic Medicines and/or cosmetics in India and for export purposes as well. This is equally applicable across India. In the Drug and Cosmetic Act, in addition to a new license, there is a provision of renewal of license, definition regarding manufacturing and guidelines for Good Manufacturing Practice. Maintaining of records of raw material used by a licensed manufacturing unit of Ayurveda, Siddha and Unani (ASU) drugs during the preceding financial year. In exercise of the powers conferred by section 33-N of the Drugs and Cosmetics Act, 1940 the Central Government, after consultation with the ASU Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945.