Rational Use of Drugs & Drugs Laws 21SELECTION OF ESSENTIAL DRUGS
Essential drugs are those drugs that
satisfy the health needs to the majority of
the population. These should always to
available in adequate quantities and in
appropriate dosage forms.
The selection of the essential drugs
should be based on the established health
need for the drugs. The list should be
reviewed periodically. Changes in the
essential drugs list are made according to
changes in the health needs, epidemiology
of the diseases for which the drugs are
prescribed and on therapeutic advances.
The WHO list of Essential Drugs
published at regular intervals is a model list
which could be used at the national,
regional, hospital and primary health centre
levels (given in appendix III).
DRUGS LAWSThe Drugs and Cosmetics Act, 1940 and rules
1945 have been passed with the objectives of
regulating the import, manufacture,
distribution and sale of drugs & cosmetics. The
Act and rules have been amended from time
to time and the latest and major amendment
was made in 1982. Schedules G & H have been
revised and new schedule X have been added
and schedules E, I & L have been deleted.
According to the Act, now there are four
categories of drugs:
i. Drugs specified in schedule C, C 1 & X.
ii. Drugs not specified in schedule C, C 1
& X.
iii. Drugs specified in schedule C & C 1
(excluding those specified in schedule X).
iv. Drugs specified in schedule X.Schedule M (Good Manufacturing
Practice – GMP) and schedule Y
(clinical trials etc.) were introduced in
1988.
Drugs and Cosmetics Rules have been
divided into 18 parts each dealing with a
particular subject. There are 2 schedules to
the Act and 26 schedules to the Rules, which
are as follows:SCHEDULES TO THE ACT
First Schedule – Names of Books under
Ayurvedic, Siddha and Unani Tibb systems.
Prior to independence, a Health Survey and
Development Committee was appointed in the
Year 1943. The committee underscored the
future role to be played by the indigenous
systems of medicine of India. In 1946, the
conference of Health Ministers resolved that
adequate provisions should be made at the
Centre and provinces for research in indigenous
systems of medicine, Ayurveda and Unani. The
conference also recommended for starting
educational and training institutions of these
systems. In pursuance of the recommendations
of the Health Ministers’s conference, a number
of committees were appointed by the
Government of India, famous of them being
Colonel R.N. Chopra (1946) and C.G. Pandit
(1949) Committees. These committees
recommended detailed outline for the
development of Indian systems of medicine.
The Government of India established in
1969 a Central Council for Research in In-
dian Medicine and Homeopathy
(CCRIMH) to develop scientific research in
different branches of Indian systems of
medicine – Unani Medicine, Ayurveda,
Siddha, Yoga, Naturopathy and Homeopa-