Abstract

SAFETY STUDY OF A NON- PHARMACOPOEIAL COMPOUND FORMULATION USED IN DIABETES MELLITUS

Reesha Ahmed* and Naeem Ahmad Khan

ABSTRACT

Safety study of herbal drugs and food items is now mandatory as per WHO guidelines. It includes determination of aflatoxin, heavy metals, pesticidal residue and microbial load. The World Health Organization (WHO) recommends that medicinal plants which form the raw materials for the finished products may be checked for the above mentioned toxic substances. Medicinal herbs are easily contaminated during growth, development and processing. After collection and transformation into dosage form the heavy metals contained in plants finally enter the human body and may disturb the normal functions of the body and may induce some serious diseases.[1] If the plant drug is a non pharmacopoeial then the uncertainty about its safety level is high as compared to the pharmacopoeial drugs which being used for quite some times. In the present study, a non pharmacopoeia antidiabetic Qurs (Tablet) (henceforth Non-Pharmacopoeial Compound Formulation /NPCF) was studied on safety parameters. All the safety parameters were studied for the test drug and were found within the permissible limits of WHO guidelines. The findings indicated that the study would help in the quality assurance of drug NPCF is safe and qualifies for further studies and application.

Keywords: Qurs (NPCF), Safety study, Heavy metals, W.H.O.