Regulatory Checks Ensuring Safety of Herbal Substances, Herbal Preparations and Herbal Medicinal Products

Global and national markets for medicinal herbs have been growing rapidly and significant economic gains are being realized [1]. As a consequence, the safety and quality of herbal medicines have become increasingly important concerns for Health Authorities including WHO [1]. Safety can be ensured by imposing stringent control on the herbal substances, herbal preparations and herbal medicinal products. This includes practicing of Good Agricultural and Collection Practices (GACP) [1,2] using pesticides to minimum, soil with minimum contamination with heavy metals (arsenic, cadmium, lead and mercury) and minimum microbial contaminants etc. The control on the microbial/fungal contaminants including aflatoxin becomes a critical part of post-harvesting of herbal substances [3–6]. The botanical identification/authentication and control on adulterants, and foreign matter play an equally important role in ensuring the safety of herbal substances. The control on solvents used for making herbal extracts also play a very important role in ensuring safety. Further, the control on residual solvents such as dichloromethane, isopropyl alcohol used as granulating or film coating agent also help to ensure the safety of the herbal medicinal products. The water used in the making of herbal extracts and the herbal medicinal products should be controlled for microbial limits and heavy metals. The individual herbal substances though having been reported safe in reported literature but when used in fixed dose combination needs to be proved to be safe by means of toxicity studies. When assessing safety, documented experience of long-term use without evidence of safety problems should form the basis of risk assessment. If toxicological risk is known, toxicity data must be generated and evidence that it does not occur in therapeutic dose and justification of advantages of the combination with increased efficacy outweighing such disadvantages should be studied [7]. References: [1] WHO guidelines on Good Agricultural and Collection Practices (GACP) for medicinal plants, World Health Organization, Geneva 2003. [2] Guideline on Good Agricultural and Collection Practices (GACP) for starting materials of herbal origin (EMEA/HMPC/246816/2005). [3] Annex 7, Manufacture of Herbal Medicinal Products of Good Manufacturing Practices (GMP) for Medicinal Products, Volume 4, Rules governing medicinal products in the European Union. [4] Quality control methods for medicinal plant materials, WHO working document QAS/05. 131/Rev. 1 [5] Guidelines on quality of herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2819/00 Rev. 1, EMEA/CVMP/814/00 Rev. 1) [6] Guidelines on specification: test procedure and acceptance criteria for herbal substances, herbal preparation and herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2820/00 Rev. 1, EMEA/CVMP/815/00 Rev. 1). [7] Guideline on the Clinical Assessment of Fixed Combinations of Herbal substances/Herbal preparations Doc. Ref. EMEA/HMPC/166326/2005.