Abstract

HERBAL MEDICINES: OVERVIEW ON REGULATIONS IN INDIA AND SOUTH AFRICA

Vijay Kumar*

Abstract

Herbal medicines, also known as Phytomedicines or Botanical medicines, involves the use of plant parts (leaves, roots, stem, flowers, and seeds) for medicinal/therapeutic purpose. It is the oldest and still the most generally used system of medicine in the world at present. The earliest recorded evidence of use of these medicine in Indian, Chinese, Egyptian, Greek, Roman and Syrian texts dates back to about 5000 years. 80% of the world population relies on herbal medicines as their primary healthcare system. As per World Health Organization (WHO) herbal medicines are of three types: Raw plant materials, Processed plant materials and Medicinal herbal products. In India, herbal medicines are regulated by the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). Regulatory provisions for Ayurveda, Unani, Siddha medicine are laid down in Drugs and Cosmetics Act 1940 and Rules 1945. On the other hand In South Africa these medicines known as complementary medicines. These regulated according to the Medicines and Related Substances Act, 1965 (Act 101 of 1965) for manufacturing, distributing, marketing of the CAM. There was no regulatory body present for controlling these medicines. Medicines Control Council with various committees control these medicines in South Africa. There is in South African Common Technical Document (Za CTD) or South African Electronic Common Technical Document (Za eCTD) present for registration of these medicines.

Keywords: Herbal medicines, AYUSH,CAM,ZaCTD,GMP.