Centre notifies phytopharmaceuticals in D and C (Eighth Amendment) Rules, 2015 in Rule 2

Bengaluru, Dec 2015: 
Union government notified in the gazette that phytopharmaceutical drugs will be inserted under a separate definition in the Drugs & Cosmetics (Eighth Amendment) Rules, 2015. The inclusion of phytopharmaceuticals in the D&C Rules comes in after taking into consideration the growing use of these drugs in the country. This rule has come into force on the date of its publication in the official gazette which is November 30, 2015.
In the Rule 2 of the D&C Rules, after clause (ea) will have an insertion: (eb): phytopharmaceutical drug which includes purified and standardized fraction with defined minimum four bio-active or phytochemical compounds. These are qualitatively and quantitatively assessed as 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 it does not include administration of pharmaceuticals by parenteral route.
Dr. DBA Narayana, Chairman, Herbs and Herbal products, Scientific Body of Indian Pharmacopoeia Commission has been championing the need for these norms for many years.
From now on pharma companies will need to submit data of the phytopharmaceutical drug along with application to conduct clinical trial or import or manufacture in the country. It mandates a brief description of the phytopharmaceutical drug giving the botanical name of the plant. This would include vernacular or scriptural name of the formulation and route of administration, dosages, therapeutic class for which it is indicated and the claims to be made for the phytopharmaceutical product.
The published literature will need to include information on plant or phytopharmaceutical drug, as a traditional medicine or as an ethno medicine. The company manufacturing phytopharmaceuticals will now need to provide reference to books and other documents, regarding composition, process prescribed, dose or method of usage, proportion of the active ingredients in such traditional preparations per dose or per day's consumption and uses.
Information on any contraindications, side effects mentioned in traditional medicine or ethno medicine literature or reports on current usage of the formulation needs to be taken into consideration, stated the gazette notification.
The published scientific reports on safety and pharmacological studies relevant for the phytopharmaceutical drug intended to be marketed will need to explicitly detail where the process and usages are similar or same to the product known in traditional medicine or ethno medicine where process or usage is different.
In addition, the companies will now need to provide the information on any contraindications, side effects mentioned or reported in any of the studies, information on side effects and adverse reactions reported during current usage of the phytopharmaceutical in the last three years, wherever applicable.
The norms insist to detail on the present usage of the phytopharmaceutical drug, to establish history of usages, provide details of the product, manufacturer, quantum sold, extent of exposure on human population and number of years for which the product is being sold.
Source: CDSCO