SAFETY AND EFFICACY EVALUATION OF HERBAL FORMULATIONS

The Safety and Efficacy of herbal formulations remain a major issue of concern especially in the developing world, where the use of herbal formulations in the form of Drugs and Cosmetics is very high. The evaluation of herbal formulations including Herbal Medicines and Cosmetics involve quality and purity assessment. The evaluation parameters are based upon Physical, Chemical, Microbiological, Therapeutic and Toxicological studies. The bioactive ingredients in the herbal formulations are tested with wide array of tests to evaluate its Therapeutic and Cosmetic potential. The formulations are tested in-vitro on Cells grown under controlled conditions. In-Vitro Cell Based Assays and Biochemical Assays are performed as per the International Regulatory norms Chemical Profiling, Antioxidant assays, Enzymatic assays, Anti-microbial Potential and in-vitro Cytotoxicity evaluations are conducted to test the adverse effects of the formulations on Humans, both in Qualitative as well as Quantitative way. In-Vitro Tests provide safety testing data that is equivalent to standard animal test methods. Concerns over safety of the Herbal Formulations have been raised more profoundly in the recent years, especially due to the Chemical nature of Active components used in the formulations. Natural alternatives over Synthetic components is gaining importance in Herbal Industry hence the Herbal formulations need to be tested for its Safety, Efficacy and Toxicity.