The Current Situation of Japanese Medicinal Plants Industry and its Significance on the Pharmaceutical Industry 2-1-2 - 農業知識入口網

2. Current situation of crude drug products
2-1. Kampo medicines
2-1-2. OTC Kampo formulations

OTC Kampo formulations have a production value of approximately 1/4 to 1/5 of Kampo formulations for prescription, and they compromise 2.9% of the entire OTC sales1). Along with the prescriptions, the OTC production value had reached its peak of 30 billion yen in 1992 and dropped thereafter. Sales have only recently recovered in part due to heightened awareness of lifestyle-related diseases and great hope in Bofutsushosan (Fang-Feng-Tong-Sheng-San) as an anti-obesity drug.

In 2007, the pharmaceutical affairs law was revised as part of the national attempt to promote self-medication. This allowed non-pharmacist, reGIStered salesman to sell Kampo medicines11). Due to these changes, the market is expected to show an upward
trend in the coming years.

In 1975, 210 formulations were selected for OTC according to the internal regulations for “Guideline for OTC Kampo formulae”5). These formulae had the potential for approval in the recent years if their effects and indications matched the Guideline, and if sufficient data proving equivalence in quality as standard decoctions were presented. In 2008, the outdated internal regulations were rearranged, added and/or revised to update the effects and indications of the OTC formulations.