DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.4.4 TIMELINE FOR PRODUCT REGISTRATIONTable VII:No.(A)Full EvaluationProduct Category* Duration(Inclusive screening process)1. New Drug Products 245 working days2. Biologics 245 working days3. Generics (Scheduled Poison) 210 working days4. Generics (Non-Scheduled Poison) 210 working days(B)Abridged Evaluation*Duration(Inclusive screening process)5.Generics (Non-Scheduled Poison)(Product categories as stated in Table V above)80 working days6.Natural Productsa) Single active ingredientb) Two (2) or more active ingredientsa) 116 working daysb) 136 working days7. Health Supplementsa) ** Single active ingredientb) ** Two (2) or more active ingredientsa) 116 working daysb) 136 working days** Applicable for:i) General or Nutritional Claims; andii) Functional Claims (Medium Claims)c) Disease Risk Reduction Claims(High Claims)c) 245 working days* Upon receipt of complete application.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 80