| |
'OTC
Drugs' in
common parlance means drugs which are legally allowed to be sold
Over the Counter without the prescription of a Registered Medical
Practitioner. The term is clumsy and creates a wrong impression
about the official status of the drugs. In India, import, manufacture
for sale and the sale and distribution of drugs and cosmetics is
regulated by the Drugs and Cosmetics Act, 1940 and its subordinate
legislation Drugs and Cosmetics Rules, 1945. The phrase 'Over
The Counter'
and its abbreviation 'OTC'
preparations have no legal recognition and are better referred to
as 'non-prescription
drugs' and/or
as 'household
remedies'.
Identification
of OTC Drugs:
Since the phrase has no legal recognition, OTC drugs have to be
identified by reductio ad absurdum logic. It may be said that the
current drug laws specify prohibitions - drugs which must not be
given without a valid prescription. What is not prohibited is permitted.
Thus, all the drugs which are not specified in the list of 'prescription
drugs' must be considered
as non-prescription drugs (or the OTC drugs).
Identification
of 'Prescription
Drugs':
'Prescription
drugs'
fall under two schedules of the Drug
Rules, 1945 - Schedule H and Schedule X. The latter consists of
habit forming, abusable drugs requiring double prescription.
The
containers of the preparations containing Schedule H or Schedule
X drugs must conspicuously display on the label the following warning:
"To be sold by retail on the prescription of a Registered
Medical Practitioner only".
The
left top corner of the container is marked by any one of the following
symbols:
| |
a) |
|
'RX'
for - Preparations containing Schedule H drugs.
|
| |
b) |
|
'NRX'
(in red colour) for - Preparations containing Schedule H drugs
which also come within |
| |
|
|
the
purview of the `Dangerous Drugs Act'.
|
| |
c) |
|
'XRX'
(in red colour) for - preparations containing Schedule X substances.
|
Some
preparations are not included in Schedule H or X. Yet, in public
interest, administrative instructions are given to the manufacturers
that their labels carry the same warning as for Schedules H or X
viz. "Warning: To be Sold by Retail on the Prescription
of a Registered Medical Practitioner Only".
There
are yet some preparations, though available without prescription,
contain Schedule G substances. They need to have a cautionary note
as follows - "Caution
- it is dangerous to take this preparation except under medical
supervision".
Premises
for the Sale of Drugs: There are three types of licensed
premises and they display on the board the appropriate description
viz. (a) pharmacy/pharmacist/dispensing chemist/pharmaceutical
chemist, (b) chemists and druggists or (c) drug store.
| |
| (a)
|
Pharmacy/Pharmacist/Dispensing
Chemist/Pharmaceutical Chemist: In such premises
|
| |
i)
|
Pharmacy
is maintained for compounding against prescriptions. |
| |
ii)
|
Supervision
of a qualified person is obligatory. |
| |
iii) |
All types of drugs (OTC as well as prescription drugs)
are supplied. |
|
| (b) |
Chemists and Druggists : In such premises |
| |
i) |
Pharmacy is not maintained, so compounding is not permitted
|
| |
ii) |
Supervision of a qualified person is obligatory |
| |
iii)
|
All
types of drugs (OTC as well as prescription drugs) are
supplied. |
|
| (c) |
Drug Stores: In such premises only non-prescription
drugs (OTC drugs) are available. Services
of qualified person are not obligatory. Supply of prescription
drugs and compounding is
not permitted. |
Decision Makers
The
Drugs and Cosmetics Rules 1945 can be amended by the Government
of India. A draft of amendment along with reasons are prepared
by the Government (Drugs Controller of India) and sent for
approval of the Drugs Technical Advisory Board (DTAB). After
approval of the Board, it is approved by the Ministries of
Health and Law. It is then published in the Gazette notification
and suggestions invited from those affected by it. Suggestions
are considered and if required, the rules amended suitably.
The
DTAB has thus a crucial role to play in the process of amendment,
as its approval is obligatory. If prior approval is not possible
in emergency cases, then the approval of the board has to
be taken within six months. The board consists of eighteen
members of which five are from the medical profession. These
five are:
| |
1. |
Director General of Medical and Health Services, Ministry
of Health and Social Welfare, |
| |
|
Government
of India. |
|
| |
2. |
President of Medical Council of India. |
|
| |
3. |
One person elected by the Central Council of the Indian
Medical Association. |
|
| |
4. |
One person elected by the Executive Committee of the Medical
Council of India (from |
| |
amongst
teachers in Medicine or Therapeutics).
|
|
| |
5. |
One pharmacologist elected by the Governing Body of the
Indian Council of Medical |
| |
Research.
|
-M.R.
Shastri, Director (Retired), Drugs Control Administration,
Gujarat
(Reproduced
from: Bulletin of the Society for Rational Therapy,
July 1991)
|
|
|
|