India had issued a set of regulation for new class of plant based drug ‘Phytopharmaceutical drug’ as an amendment to the Drugs and Cosmetic Rules 1945. Age old traditional systems of medicine practiced in India ‘Ayurveda’, ‘Siddha’ and ‘Unani’ medicines. Ayurvedic, Siddha or Unani drugs include all medicines in accordance with the authoritative books of Ayurvedic, Siddha and Unani tibb. systems of medicine specified in the first Schedule of Drugs and Cosmetics Act 1940. This article aims to analyse opportunities and challenges in development of phytopharmaceuticals drug in India through SWOT in development of phytopharmaceutical analysis. It was observed that market for phytopharmaceutical drug has massive opportunity in national and international market; however there is a need for investment and commitment in promoting research and development in the area of phytopharmaceuticals drug.
Key words: Phytopharmaceutical drug, SWOT, Drugs and Cosmetics rules, Opportunity, Challenges.