DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)- If a product contains equal to or less than 20% of active ingredients ornatural ingredients with pharmacological and/or therapeutic properties, theproduct shall be regulated by FSQD.- Notwithstanding this general rule, if a product contains specific activeingredients which possess high pharmacological or therapeutic potencies,the product may be regulated by NPCB even if these active ingredients arepresent in less than 20%.vi) When there is greater uncertainty regarding the safety of a product, it shall beregulated by NPCB. This is to enable closer monitoring of such products, so as tosafeguard the interest of the consumer.vii) Notwithstanding the above points, the following ingredients do not follow the80:20 ratio general rule mentioned above and shall be regulated by NPCB:- Plant sterols/ stanols and esters that are consumed ≥ 3.5g/day- Psyllium husk that are consumed ≥ 3.5g/dayb) Other criteriaThe following may be used as additional criteria to assist in the classification of FDIproducts:i) Intended use and claims made by the productEventually, if a product has been decided to be regulated by FSQD, no claimsshould be made, other than those permitted by the Food Regulations.ii) Dosage form- Any foods or combination of foods that are regulated under FSQD shall notbe in the form of soft gel, capsule or tablet that is to be directly swallowed.National Pharmaceutical Control BureauFirst Edition, January 201340