Background: 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. Objective: The article aims to analyse opportunities and challenges in development of phytopharmaceutical drug in India through SWOT analysis. Methods: The Strength, Weakness, Opportunities and Threats (SWOT) in development of phytopharmaceutical drug in India was analysed through review of published literatures. Observation: The SWOT analysis showed that India being leader in the herbal industry has massive opportunity in national and international market for phytopharmaceutical drug. It was also observed that the phytopharmaceutical drug market has vital opportunity for expansion both in developed and developing countries. Conclusion: There is a need for investment and commitment in promoting research and development in the area of phytopharmaceutical drug.
Key words: Phytopharmaceutical drug, SWOT, Drugs and Cosmetics rules, Opportunity, Challenges.