Role of value chain in easing regulatory processes and approvals for herbal products

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Suma Krishnaswamy

Scientific Tracks Abstracts: Pharmaceut Reg Affairs

Abstract :

The WHO has estimated the demand for medicinal plants is approximately $14 Billion per annum (2006). The demand is growing at the rate of 15 to 25% annually and by 2050 trade will be up to US$ 5 Trillion. Yet the herbal industry is still disorganized and relies heavily on the wild collection of raw material. There is inconsistency in quality, content and therapeutic value. Standardization of raw materials collected from wild sources poses a daunting task as it involves several layers of collectors, handlers and commission agents. Considerable measure of standardization and organization can be introduced to this ill-organized sector by adopting a structured value chain that ensures adequate returns for every stakeholder: From farmer/collector to service personnel. Though value chains are the fulcrum of several advanced enterprises like the food industry, this concept has completely by-passed the Herbal industry. Few manufacturers have explored the urgent need for fool-proof value chains of herbal medicines and derivative products. NGOs or governmental studies identified have confined themselves to achieving sustainable livelihoods in small pockets with maximum sociological, ecological and economic impact. There are crucial gaps in medicinal plant research, raw material standardization and studies on drug interactions in polyherbal products which impact acceptability of Indian herbal products in the global arena. Establishing a well defined value chain for the herbal segment can ensure increased accountability, quality, profitability, and fair trade, safe and smooth supply of herbal medicines. A thorough technical and economic feasibility study of the value chain, long term involvement, familiarity of the diverse agro climatic zones and a deep understanding of the prevalent farming systems are required to ensure the success of the chain. The ultimate proof of success of the chain that truly creates shared value lies in establishing various systems, processes and limits acceptable to the most stringent of regulatory authorities across the world: After all, the herbal industry revolves around the betterment of human and animal lives and no compromises are permitted.

Biography :

Ms. Suma Krishnaswamy, Masters & Gold Medalist in Plant tissue culture, established Cambium Biotechnologies at Bangalore, India in 1998. Cambium Biotechnologies has focused on propagation and cultivation of several RET medicinal plants, serving customers globally under strictly adhered-to Non-disclosure agreements (NDAs) over the past fifteen years. Location specific package of practices, harvesting and post harvesting processes are developed for farmers cultivating our plants. The herbal raw material thus harvested is processed further into powders or standardized extracts and sold to pharmaceutical manufacturers or extraction companies. We also develop Drug Master Files, Dossiers in CTD /ACTD formats for mono and poly herbal products to be submitted for regulatory approvals in the importing country.