Reference Research Documents

Ayurveda, Siddha and Unani (ASU) systems of medicine are experiential and time-tested in nature. Their therapeutic potential and relevance needs scientific exploration with acceptable methodologies. In the emerging scenario of scientific endeavors, when advancements are being made to have complete understanding..

Purpose

The purpose of this document including its attachments is to streamline and enable consistent preparation of Community herbal monographs by the EMEA Committee on Herbal Medicinal Products (HMPC)

Macroscopic

Roots straight, unbranched, thickness varying with age, roots bear fibre-like secondary roots, outer surface buff to grey-yellow with longitudinal wrinkles; crown consists of remains of variously thickened stem bases; fracture short and uneven; odour characteristic; taste bitter and acrid.

Clinical Trials

Nature of trials - The clinical trials required to be carried out in the country before a new drug is approved for marketing depend on the status of the drug in other countries.

Traditional medicine Traditional medicine has a long history. It is the sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment

Good Manufacturing Practice (GMP) is a production and testing practice that helps to ensure a quality product. GMP guidelines are not prescriptive instructions on how to manufacture products. These are a series of general principles that must be observed during manufacturing. When a company is setting up its quality

GUIDELINES FOR PROCESSING OF PATENT APPLICATIONS RELATING TO TRADITIONAL KNOWLEDGE AND BIOLOGICAL MATERIAL

It has been reported that the Indian Patent Office is granting patents on the use of traditional knowledge (TK) of India, particularly relating to the Ayurveda, Unani and Siddha systems of medicine, etc and patents have been granted on inventions related to biological resources obtained from India without taking adequate

Introduction:

In the past decade there has been renewed attention and interest in the use of traditional medicine globally.,

I. Principles of essentiality whereby the research entailing the use of human participants is considered to be absolutely essential after a due consideration of all alternatives in the light of the existing knowledge in the proposed area of research and after the proposed research....

THE DRUGS AND COSMETICS ACT, 1940 as amended by the Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962, the Drugs and Cosmetics (Amendments) Act, 1964, the Drugs and Cosmetics (Amendments) Act, 1972, the Drugs and Cosmetics (Amendments) Act, 1982, the Drugs and Cosmetics (Amendments) Act, 1986 and the Drugs and Cosmetics (Amendments) Act, 1995.