[india-drug] Response to OTC drugs

["S. Srinivasan" <sahajbrc@icenet.co.in>]

Response to OTC drugs
-----------------------

Dear Idrug participants, 

I am enclosing article on OTC drugs by a respected retd FDA
Commissioner of Gujarat.
 
S.Srinivasan


OTC DRUGS : SOME LEGAL ASPECTS

'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: 
1.	'RX' for - Preparations containing Schedule H drugs.
2.	'NRX' (in red colour) for - Preparations containing Schedule H drugs
which also come within the purview of the `Dangerous Drugs Act'.
3.	'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. 
Pharmacy/Pharmacist/Dispensing Chemist/Pharmaceutical Chemist: In such
premises
1.	Pharmacy is maintained for compounding against prescriptions.
2.	Supervision of a qualified person is obligatory.
3.	All types of drugs (OTC as well as prescription drugs) are supplied.
Chemists and Druggists : In such premises
1.	Pharmacy is not maintained, so compounding is not permitted
2.	Supervision of a qualified person is obligatory
3.	All types of drugs (OTC as well as prescription drugs) are supplied.

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:
Director General of Medical and Health Services, Ministry of Health and
Social Welfare, Govt of India
President of Medical Council of India.
One person elected by the Central Council of the Indian Medical
Association.
One person elected by the Executive Committee of the Medical Council of
India (from amongst teachers in Medicine or Therapeutics).
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)





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