(1998; 88 pages)
8.6 Responsible government agency for regulation
The responsible government agency could be the Drug Regulatory Authority or other government agencies with similar responsibilities. It is recommended that a special unit for herbal medicines should be created under the responsible agency for the regulation of medicines.
The responsible agency should review and evaluate all the data received from manufacturers or wholesalers. The applicants should be informed on time whether or not their products have been accepted for notification (listing) or registration.
The responsible agency should keep all the records for registration or notification of herbal medicines.
A registration or notification number should be given when an herbal medicine has been accepted with the drug regulatory authority. A certificate of registration or notification will be issued to each herbal medicine accepted by the relevant authority.
The regulatory authority should provide information to medical practitioners, pharmacists, owners of herbal drug stores and the public on the regulatory process and should have available a list of accepted medicinal herbal products.