The challenges of mislabeled and adulterated herbal supplements with undeclared active pharmaceutical ingredients

Objectives: There is increasing recognition that traditional herbal drugs may contain undeclared active pharmaceutical ingredients (APIs). This issue has drawn a great deal of attention with the introduction of various hand- made and factory-made herbal pharmaceutical dosage forms by traditional herb shops for the treatment of medical complications such as obesity, diabetes mellitus, impotence and opioid addiction and also to maintain well-being. Many patients are tempted to use hand-made herbal supplements due to the idea that drugs with natural origin have fewer side effects and therefore, are safe for self-medication. Undeclared drugs may affect pharmacokinetic profiles and trigger untoward effects as a result of drug-drug or drug-herb interactions. However, negligible knowledge is available about APIs’ content of adulterated and traditionally made herbal preparations and concerns continue to be expressed over the quality consistency of these drugs by the health care systems all over the world. The problem of counterfeit drugs varies between countries in relation to their health policy. This issue is more important in developing countries where supervision, regulation and legal issues are weakest. Analysis of fake and adulterated herbal formulations is one of the important areas of scientific research within the fields of quality control, complementary medicine, forensic and analytical toxicology. This abstract will focus on the adulteration practice in different drug categories. The aim of this work is to introduce the most prevalent adulteration practice in herbal products used therapeutically by the patients sold in herb shops in Iran.Methods: Adulterated herbal drugs were analysed in Forensic toxicology laboratory using HPLC and GC/MS instrumentations.Results: Different kinds of herbal weight gain supplements are laced by dexamethasone and cyproheptadine. Diphenoxylate, tramadol, codeine, sertraline and fluoxetine were the most prevalent drugs detected in opioid substitution treatment supplements. Tramadol, caffeine, fluoxetine, rizatriptan, venlafaxine and methadone were detected in herbal weight loss drugs. Herbal sexual enhancer drugs contained sildenafil, tramadol and diazepam.Conclusion: Different kinds of herbal drugs are adulterated with legitimate and controlled drugs. Information propagation is needed regarding the use of adulterated herbal supplements.

Keywords:

Adulterated herbal supplements , Undeclared active pharmaceutical ingredients , Analytical toxicology , Herbal drugs safety