DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)For product containing Senna Leaf (Cassia) and Rhubarb/ Radix etRhizoma Rhei, please state:- “Do not use when abdominal pain, nausea or vomiting ispresent.”- “Frequent or prolonged used of this preparation may result independence towards the product and „imbalanced electrolytes‟.”For product containing St. John‟s Wort, please state:The product may interact with other medicines. Pleaseconsult a doctor/ pharmacist before using it.For product containing substance from seafood, please state:“Derived from seafood.”For product with indication “To regulate menstruation/ To improvemenstrual flow”, please state:“Contraindicated in pregnant women.”For product with indication „To reduce body weight‟, please state thesestatements, (unless proven otherwise):- “Balanced diet and regular exercise are essential.”- “Safety on long term use has not been established.”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 282