ABSTRACT:
Herbal drugs have occupied a privileged position in India for centuries in various formulations of traditional medicines. Along with the tradition it also has brought faith and trust based evidence of efficacy and safety to the common perception However, present day consumers with analytical thinking have started asking questions about the validation and authenticity of faith based claims. Thus there is a necd for generating scientific evidence not only for efficacy but also for safety of herbal drugs. Highly protectionist environment for traditional medicines in India has been counterproductive and the major stakeholders of ancient Indian Systems of Medicine (ISM) like Ayurveda have taken refuge of traditional use for how not to do validation of claims on safety and efficacy. Full potential of herbal drugs by Ayurvedic industry still remains unexploited. On the other hand in case of RAD based Pharmaceuticals the investment on R&D has suddenly dropped due to high risk discovery expenses and lower productivity. Ministry of Health, Govt of India have recently introduced a New Class of Drugs called Phytopharmaceuticals PPh), this would be included under rule 122E of the Drugs and Cosmetics Acts and Rules as new (Allopathic) drug. It would be developed broadly on the same guidelines as are applicable for synthetic drugs Phytopharmaceutical drugs have been differentiated from Ayurvedic. Siddha and Unani (ASU) Drugs by definition. While whole plant and its whole extracts would remain under the ambit of ASU, their furtherfractions with minimum 4 isolated bioastive or marker compounds would constitute a l'hytopharaceuical drug. Emergence of this new class of drue is likely to boost research and development activity in this sector by RAD based Pharmaceutical companies as wel as public funded Rscarch institutes like CSIR. This move of the Govt of imaia Is expected to boost the sector of plant based medicines TEkann ts anl would provide a policy initiated impetus. Being new venture, lot of efforts would be required to create awareness about this new development among various stake holders including Pharma and Ayush industry besides among the public funded Research Institutes as well as academic institutions.