**10. Conclusion**

October 1993). Directive No. 435/81 defines herbal drugs with therapeutic proposed claims and/or dosage recommendations as being medications, restricted from being sold in drugstores and pharmacies. Registration for marketing authorization is required for herbal products. These products are lawfully distinguished as follows: (1) drugs intended to alleviate, cure or prevent disease; (2) food products with therapeutic properties and for medicinal use,

In Europe, the European Directive 2004/24/EC released in 2004 by the European Parliament and by the Council of Europe provides the guidelines for the use of herbal medicines. The guidelines state that for herbal medicine to be released in the market, it needs authorization from the national regulatory authorities of each country in Europe and the herbal products must have a standard level of efficacy and safety. The registration of herbal products from outside the European Union (EU) require substantial evidence of their medicinal use, at most a period of 15 years within EU and 15 years elsewhere [3]. In Germany, more than 300 monographs on medicinal plants have been regulatory evaluated, and in France more than 200

The widespread use of herbal medicine in Brazil is favored by two present public policies i.e. the National Policy on Integrative and Complementary Practices in the Public Health System (PNPIC) and the National Policy on Medicinal Plants and Herbal Medicines (PNPMF), through the Law 971/2006 and the Declaration 5813/2006, respectively. Currently, 382 herbal medicines are registered in Brazil, 357 of these are single medicines and the other 25 are com-

Herbal medicine has gained increasing popularity in the last two decades in industrialized countries. The congress of the United States of America (USA) established the Office of Alternative Medicine in the year 1989 within the National Institute of Health (NIH). This was formed to interest scientists in the field of medicinal plants [3]. According to the 2007 NIH survey, 4 out of 10 adults (38.8%) and 1 out of 9 children (11.8%) used some form of herbal medicine [37]. In USA, presently about 25% of prescription drugs contain at least one plant derived ingredient [21], the herbal market in this country has doubled from \$4 billion since 1996 [6]. In 1989, the European Scientific Cooperative on Phytotherapy was formed with an aim to advance herbal medicine [3]. The herbal medicine market in European countries has been growing steadily from \$6 billion in 1991 to over \$20 billion currently, particularly in Germany, France and Italy [4, 6]. In Germany, herbal medicine is identified as one of the elements of naturopathy [46], approximately 600–700 plant derived medicines are accessible and prescribed by approximately 70% of German physicians [47]. In 2011, 20% of herbal drugs were sold as prescriptions and 80% over the counter in Germany [46]. In the year 2005, The National Centre for Complementary and Alternative Medicine at the National Institutes of Health in the USA spent about US\$ 33 million on herbal medicine, the National Canadian Institutes disbursed approximately US\$ 89 million for research in traditional therapies in 2004. These scientific evaluations have led to an upsurge in the investment of herbal medicine [3].

herbs have been recorded as acceptable ingredients of herbal medicine [4].

**8. The market for herbal medicine in the developed world**

and (3) food products with nutritious purposes [11].

222 Herbal Medicine

posed of more than one medicinal plant [45].

The use of herbal medicine is not restricted to developing countries. Over the years, there has been an escalating interest in the use of herbal medicine worldwide. This has greatly expanded the demand for plant products, since herbal medicine has an advantage of being inexpensive with minimal side effects compared to synthetic medicines. The growth of the herbal drug market has attracted pharmaceutical companies which in turn have driven scientific validation and clinical studies on herbal medicines. Thus far, few programs have been established to study the safety and efficacy of herbal medicines as originally proposed by the WHO Guidelines for the assessment of herbal medicines. These guidelines have been helpful in establishing the role of herbal medicine in the health care industry. However, the data to provide a precise assessment on the safety, quality and efficacy of herbal medicine is inadequate generating concerns regarding the use of herbal products.
