Rational Use of Drugs & Drugs Laws 23thy. Research activities in these systems
continued under the aegis of the CCRIMH
until 1978, when it was split into four sepa-
rate research councils, one each for Unani
Medicine, Ayurveda and Siddha, Yoga and
Naturopathy, and Homeopathy, so as to
further develop these systems in conso-
nance with the basic philosophies of the
respective systems. Also, with a view to
streamlining education and regulating
practice in Indian systems of medicine –
Ayurveda, Unani Medicine and Siddha, the
Government of India set up by an Act of
Parliament, Indian Medicine Central Coun-
cil Act 1970, the Central Council of Indian
Medicine (CCIM).
In 1995, the Government also set up a
full-fledged Department of India Systems of
Medicine & Homeopathy (ISM & H) in the
Union Ministry of Health & Family Welfare
to further boost the development of Unani
Medicine and other Indian systems of
medicine. The Department of ISM & H has
been renamed as Department of Ayurveda,
Yoga & Naturopathy, Unani, Siddha and
Homeopathy (AYUSH).
Second Schedule – Standard to be
complied with by imported drugs and by
drugs manufactured for sale, sold, stocked
or exhibited for sale or distributed.
In addition the following appendices are
also prescribed:
Appendix
I. Data required to be submitted with
application for permission to market a
new drug.
II. Format for submission of clinical trial
reports.III. Animal toxicity requirements for
clinical trials and marketing of a new
drug.
IV. Number of animals for long term
toxicity studies.
V. Patient consent form for participation
in a phase I clinical trial.
VI. Four groups of fixed dose combinations
and their data requirements.
NARCOTIC DRUGS & PSYCHOTROPIC
SUBSTANCES ACT & RULES
Opium was brought under legislature
control as far back as in 1857. The primary
aim of the Opium Act was the protection
of the public welfare by preserving health
& eliminating undesirable social and
moral effects which are associated with
indiscriminate use of opium. Govt. of
India passed the Dangerous Drug Act in
1930 with a view to control certain
operations in the dangerous drugs and to
centralise and vest the same in the central
government.
Further to “consolidate and amend the
law relating to narcotic drugs, to make
stringent provisions for the control and
regulation of operations relating to narcotic
drugs & psychotropic substances, and
concerned matters”, the “Narcotic Drugs &
Psychotropic Substances Act & Rules was
passed in September 1985.THE MEDICINAL & TOILET PREPA-
RATIONS (EXCISE DUTIES) ACT &
RULES
The Medicinal and Toilet Preparation
Act was passed in 1955 and Rules were
passed in 1956 and came into force in April,