DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)6.9 CANCELLATION, SUSPENSION, AMENDMENT BYTHE AUTHORITYThe Authority may, at any time and without assigning any reason suspend or cancelthe registration of any product, and may amend the conditions of registration. Theholder of the registration certificate shall immediately surrender to the Authority theregistration certificate upon cancellation or suspension of the registration of theproduct.The Authority may, at any time and without assigning any reason suspend or cancelthe registration of any product, and may amend the conditions of registration, uponwhich the registration certificate is no longer valid.6.10 DIRECTIVESThe Senior Director of Pharmaceutical Services may issue written directives orguidelines to any person or a group of persons as he think necessary for the bettercarrying out of the provisions of these Regulations and which in particular relate to:a) Product quality, safety and efficacy;b) Labeling;c) Change of particulars of a product;d) Transfer of licenses;e) Manufacturing;f) Storage includes requirements as to containers;g) Retailing;h) Promotion of sale including product information;i) Product recall;j) Product disposal;k) The cost of product recall or product disposal;l) Clinical trials; orm) Records and statistics pertaining to manufacture, sale, supply, import or export ofany products.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 68