HYBRID EVENT: You can participate in person at Paris, France or Virtually from your home or work.

8th Edition of International Conference on

Traditional Medicine, Ethnomedicine and Natural Therapies

June 05-07, 2025 | Rome, Italy

Traditional Medicine 2023

Safety rules and regulations for Herbal medicines

Speaker at Traditional Medicine, Ethnomedicine and Natural Therapies 2023 - Mangala Kotnis
Private Practitioner, India
Title : Safety rules and regulations for Herbal medicines


Herbal products are usually not evaluated for purity and consistency of active compounds, they also often contain contaminants. Furthermore, it is believed that if a drug is effective, it will not totally be safe and will have side effects. Therefore, herbal medicines as drugs may have side effects, too Taking the wrong dose or wrong combination or using the wrong part of the plant may cause side effects or be poisonous (toxic). As per WHO (World Health Organisation) For medicines to work safely, it’s vital to have strong systems in place to report any undesired side effects or “adverse drug reactions “. Many undesired drug reactions are due to lack of adherence to good manufacturing practice (GMP), poor regulatory measures and adulteration. Many in vivo tests on aqueous extracts largely support the safety of herbal medicines, whereas most in vitro tests on isolated single cells mostly with extracts other than aqueous ones show contrary results and thus continue the debate on herbal medicine safety. It is expected that toxicity studies concerning herbal medicine should reflect their traditional use to allow for rational discussions regarding their safety for their beneficial use. While various attempts continue to establish the safety of various herbal medicines in man, their cautious and responsible use is required.  may be due to factors independent of the medicine one of them can be interactions with other drugs (including traditional medicines). Hence there is strong requirement of guidance from regulators. WHO has come up with guidelines for assessing quality of herbal medicines with reference to contaminants and residues which is quite handy. Even FDA has come up with Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation. Government of India has come up with General Guidelines for safety and toxicity of Ayurvedic formulations. All these documents and data are quite important to understand when we look at herbal medications.

Audience Take Away Notes:

  • They will learn the guidelines and regulations
  • It will help them to be updated with information if they are in business of herbal drugs
  • Yes this research that other faculty could use to expand their research or teaching
  • It explains what all points need to be considered from safety angle
  • Companies working in this sector can work towards coming up with standardized product.


Dr Mangala Kotnis graduated as Medical Doctor from University of Mumbai, later completed her postgraduation (PhD) in Science “Standardisation of Herbal medicines using analytical methods” (with patent on the same) and MBA in Entrepreneurship from SGVU and post graduate Diploma in Marketing. Medical Thought Leader with 20 years of experience in pharmaceutical industry Ex Novartis, Ex Abbott with cross functional Medical Leadership Skills, a proactive hands-on approach to Medical Direction, Has ability to work productively with diverse set of internal and external stakeholders, strong expertise in clinical/real-world evidence generation, and has experience of science led business acumen across domestic and international markets with local (CPO India), Regional (AMAC) experience and global experience.