Herbal products and their formulations have a large market at the global level. A significant portion of the worldwide population relies upon herbal treatment. Their apparent non-toxic and cost-effective nature appeals to the population and drives researchers to pursue them for drug development. However, due to the lack of scientific evidence, their conventional preparation, poor regulation and control make these an unseen threat to the people. There has been a long-standing argument that allopathic medicines are better than herbal medicines due to their specificity and precision. To compete with modern medicines, a concept of science-based phytopharmaceutical drugs was introduced through a draft amendment notified to the Drugs and Cosmetics 1940 and Rules 1945. The amendment has introduced a definition for botanicals and their scientific evaluation for quality safety and efficacy by the Central Drugs Standard and Control Organization (CDSCO) office as a marketing authorization requirement. The present article discusses the advantages and challenges faced in the development of phytopharmaceuticals, and how they differ from dietary supplements and herbal drugs. It also gives consolidated information on Phytopharmaceuticals and their regulatory and Pharmacopoeial status with an exemplary PPI monograph – Aegle marmelos. The plant selection was done based on extensive research using the PRISMA approach. A detailed view of the opportunities and challenges provided by phytopharmaceuticals is explained in the present review.
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