Phytopharmaceutical Drug

Phytopharmaceutical Drug

Globally, herbal medicine has been considered an important alternative to modern allopathic medicine. Herbal medicines are very popular throughout the globe, however, only a few medicinal herbs have been scientifically evaluated for their potential in medical treatment. In most countries, the herbal drugs are poorly regulated and are often neither registered nor controlled by the health authorities.

In India, plant based products used as medicines come under the category of Phytopharmaceuticals. They include Ayurvedic, Siddha, Unani (ASU) Drugs and any other plant based product which is used as medicine. The phytopharmaceuticals are under the purview of the Central Drugs Standards Control Organization (CDSCO).

The CDSCO has released a draft regulation, as an amendment to the Drugs & Cosmetic Rules 1945, which defines and outlines regulations for phytopharmaceuticals. This gazette notification defines regulatory provisions for phytopharmaceuticals and regulatory submission requirements for scientific data on quality, safety, and efficacy to evaluate and permit marketing for an herbal drug on similar lines to synthetic, chemical moieties.

According to the rule 2 of the Drugs and Cosmetics Rules, 1945, “Phytopharmaceutical Drug” includes purified and standardised fraction with defined minimum four bio-active or phytochemical compounds (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.’.

In Schedule Y, the newly added Appendix I B describes data to be submitted along with the application to conduct clinical trial or import or manufacture of a Phytopharmaceutical Drug in the country. The regulatory requirements for NDA for the Phytopharmaceutical Drug include standard requirements for a new drug-safety and pharmacological information, human studies, and confirmatory clinical trials. For Phytopharmaceutical Drug, there is a lot of stress on:

  1. Available information on the plant, formulation and route of administration, dosages, therapeutic class for which it is indicated and the claims to be made for the Phytopharmaceutical, and supportive information from published literature on safety and efficacy and human or clinical pharmacology information
  2. Data generated on :
    • Identification, authentication, and source of the plant used for extraction and fractionation
    • Process for extraction and subsequent fractionation and purification
    • Formulation details of Phytopharmaceutical Drug
    • Manufacturing process of formulation
    • Stability data.

CliniExperts is a complete product pipeline development partner for Phytopharmaceutical companies developing and commercialising drug products. Phytopharmaceutical Drugs are regulated product hence if they are to be imported, manufactured, stored, distributed, tested or sold in India, they have to be registered with the licensing authority (CDSCO) through various procedures. Products tested or sold in India, could be manufactured locally or can be manufactured outside India. Any manufacturer who wishes to import and market products manufactured outside of India, should register the manufacturing site and the list of products which they propose to import for sale.

CliniExperts provide end-to-end solution for your Phytopharmaceutical Drugs need. This end-to-end service offering will help you import, manufacture, test, conduct clinical trials and distribute your products in India efficiently.

Reference:

  1. The Gazette of India Extraordinary PART II—Section 3—Sub-section (i)New Delhi, Monday, November 30, 2015/ Agrahayana 9, 1937.
  2. Bhatt A. Phytopharmaceuticals: A new drug class regulated in India. Perspect Clin Res 2016;7:59-61.

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