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Overview

Globally, herbal medicines have been considered an important alternative to modern allopathic medicine. Herbal medicines have been used by the humanity since time immemorial for various healthcare needs. Around 80% of the population of developing countries uses herbal medicines for treatment of various diseases. India is one of the largest producers of medicinal herbs and is called as botanical garden of the world. There is unmet medical needs for the discovery and development of phytopharmaceutical drugs.Although the herbal medicines are very popular in the society, only 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. The regulatory requirements for phytopharmaceuticals were notified by the Ministry of Health and Family Welfare, Government of India, which include the scientific data on quality, safety, and efficacy of an herbal drug on similar lines to synthetic, chemical moieties. Phytopharmaceutical drug is defined as purified and standardized 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. For phytopharmaceutical drug, there is a lot of stress on identification, authentication, and source of the plant used for extraction, fractionation, stability etc. 

 

 Mission and Goals:

 Monograph Development: With the ever-increasing use of herbal medicines and the global expansion of the herbal medicines market, quality and safety has become a major concern for the health of the people. The quality of herbal medicines has a direct impact on their safety and efficacy. Thus, to regulate the quality standards, various identification and quantification procedures are mentioned in herbal monographs of Indian Pharmacopoeia.

 The herbal drug monographs in IP include crude herbs, processed herbs, herbal materials, herbal preparations and finished herbal products that contain as active ingredients, the parts of plants, or plant materials, or combinations thereof. The specific monograph of IP of a herb details the Title and Synonym if any, Definition, Limits of active ingredient/Marker compounds, Description, Category, Identification, Chemical Tests, Assay of the marker constituents, Contaminants, Specific Tests, Storage conditions etc. Monographs are included in IP based on documented quality specifications and suggestions/feedback from the stakeholders. IPC received appreciation from different stakeholders in the field of herbal drugs till date, IPC has published 150 herbal monographs and 15 herbal monographs are in pipeline for the next edition of IP-2018. There will be nearly 10% rise in their number per year. These monographs included in IP have received wide acceptance globally and some of these monographs now appear in pharmacopoeias of other nations with or without further changes. In view of this IPC has also received an observer status in EDQM and in EP.

phytopharmaceuticals chart image

 

Competencies:

Facilities available:

S.No

Instruments available

1

Semi automatic HPTLC (ATS5, CAMAG)

2

HPLC gradient mode with auto sampler, PDA detector (Agilent)

3

Microbalance (up to 6 decimal digit)

4

Inverted Microscope with fluorescent filter (Nikon)

5

Rotavapor (Rotatory Evaporator)

6

Temp. controlled Water Bath with shaker

7

Vortex mixer

8

pH meter

9

Ultrasonic Bath

10

Refrigerated Centrifuge

11

Distilled water Assembly

12

Gel electrophoresis system

13

Vertical deep refrigerator (-80º C )

14

PCR Thermal Cycler

15

Incubator

16

UV visualiser

17

Chemical Fume hood