DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)3. PRODUCT SPECIFIC REQUIREMENTS3.1 FOOT PATCHESA foot patch which contains herbs with a health claim needs to be registered with theAuthority.Summary of registration for foot patches is described below:a) Product Indication- Traditionally used fora) General health;b) Promoting blood circulation;c) Relieve fatigue.- If there are other indications other than those mentioned above, applicant isrequired to submit clinical study data to support the proposed indication.b) Active ingredient/ Excipient- May only contain active ingredient which are classified under the category ofNatural Products (Traditional).- Pharmaceutical ingredients which have dual-function as an active ingredientand excipient, e.g. Vitamin C can be used as excipient.- However the maximum allowable amount for the excipient in the traditionalproduct has to follow the pharmacopoeia limits established. If for example inthis case the amount of Vitamin C is more than 0.1%, the product shall beclassified as an OTC product. The product will then have to fulfill therequirement for the registration of an OTC product.c) Certificate of Analysis for Finished Product- It is required with at least one batch data for registration.d) Certificate For Free Sale- CFS from the regulatory authority of the country of origin of the productdepending on the product classification of that product in that countryNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 299