Herbal medicines: challenges and regulation


Herbal medicines: challenges and regulation

Herbal medicines are the ancient method for treating diseases. Although people in developing countries depend on traditional herbal medicines, herbal products also play an important role in the healthcare systems of industrialized countries due to on-going health trends for substituting natural products for potentially harmful chemicals. Herbal Medicines contain an active ingredient, aerial, or underground parts of the plant or other plant material or combinations. Global survey on national policy on traditional medicine and regulation of herbal medicines signified that about 50 countries including China, Japan, and Germany already have their national policy and laws on regulations of traditional medicines.

Challenges:

Several challenges on herbal drug include financial, ethical, product standardization (quality control), the design of the study and the regulatory requirements before filing an investigational new drug for conducting large phase III trials.
  1. Lack of research data
  2. Lack of mechanisms to control and regulate TM/CAM advertising and claims
  3. Lack of appropriate mechanisms to control and regulate herbal products
  4. Lack of appropriate mechanisms to monitor and regulate TM/CAM providers
  5. Lack of financial support for research on TM/CAM
  6. Lack of expertise within national health authorities and control agencies
  7. Lack of mechanisms to monitor safety of TM/CAM practice
  8. Lack of cooperation channels between national health authorities to share information about TM/CAM
  9. Lack of mechanisms to monitor safety of TM/CAM products, including herbal medicines
  10. Lack of education and training for TM/CAM providers

Regulation of herbal medicines:

The regulatory classification of herbal medicinal products relies on regional legislation. Dissolution testing principles of herbal medicines exhibit regional differences as well as differences from regulations for chemical medicines.

More than 80% of people in developing countries depended on herbs. The regulation of herbal drugs in developed countries where herbal drugs are produced and utilized in accordance with good manufacturing practice (GMP) and good clinical practice.

Asian countries like China, India, and Korea, traditional is treated with same respect as modern pharmaceutical and are also included in the national health scheme.



Comments

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