Phytopharmaceuticals are the newer class of drug including enrich fraction containing at least four specific chemical markers with one biomarker.
Let us see what is a phytopharmaceutical drug by definition. “Phytopharmaceutical drug” includes purified and standard fraction with defined minimum four bio-active or phyto-chemical compound (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include administration by parenteral route as specified in Rule 2 (eb) of the Drugs & Cosmetics (D&C) Rules, 1945.
Minimum four compounds shall be identified as bio-active / phyto chemical compounds. It is ideally if all of them are bio active, hence the condition of identification of minimum four compounds from fraction is given.
Phytopharmaceutical drug differ from ayurvedic, siddha or unani (ASU) under Section 3 (a) & (h) of Drugs & Cosmetic Act 1940. Phytopharmaceutical drug are an updated path for the plant based enrich fraction to be used as a drug, which is specifically not a part of Ayurvedic literature till the present time. Ayurvedic, Siddha or Unani drugs include all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of (disease or disorder in human beings or animals, and manufactured) exclusively in accordance with the formulae described in, the authoritative books of ayurvedic, siddha and unani tibb systems of medicine specified in the first Schedule. However, phytopharmaceutical drugs are fraction of crude extract and are distinctly differentiated by being purified and standardized.
Phytopharmaceutical drug for which marketing authorization is issued need to be sold only against prescription of a R.M.P. / specialist / or it can be sold without prescription.
Plants become a great source of interest in modern system of therapeutics as drugs, nutraceuticals, pharmaceutical intermediates, folk medicines, and chemical entities for synthetic drugs Phytopharmaceuticals is a new class of drug may encourage the interest and demand of plant-based therapeutics for unmet medical needs professionally as unlike conventional pharmaceuticals
phytopharmaceutical is a balanced approach which trust everything but underlines the revalidation of the specification of the plant material. Some of the examples of these are
- Carotene, lycopene, lutein and zeaxanthin have been reported to be in reverse to the risk of cardiovascular diseases, some kinds of cancers and eye disorders.
- Lutein has various kinds of therapeutic effects and protects against uterine, prostate, breast, colorectal and lung cancers gastro intestinal cancer.
- Lycopene lowering in the chance of chronic disorders like cancer and cardiovascular diseases. Increase in serum and tissue lycopene levels decreases the risk of various chronic diseases
- Phytosterols lower total and blood cholesterol level by preventing cholesterol absorption from the intestine.
- Resveratrol has been reported to exert neuroprotective and cardioprotective effects.
- Flavonoids are polyphenolic compounds which are usually obtained in fruits and vegetables like berries, legumes, tea, grapes, These are reported to be active against various bacterial disease, oxidation, viral diseases and algesia. Flavonoids are reported to be active against free radicals; free radical cellular signalling, inflammation, allergies, platelet aggregation, microbes, ulcers, viruses, tumours and hepatotoxins
- d-limonene is the commonest monocyclic monoterpene, found in orange peel oil and inhibits pancreatic cancer.