Notification S.R.O. 1080 (1)/78: In exercise of the powers
conferred by Section 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal
Govern moist is pleased to make the following rules, the same having been
previously published as required by sub-section (3) of the said section, .namely
:--
1. Short title and commencement: (1) These rules may bc called
the Drugs (Specifications) Rules, 1978.
(2) They shall come into force at once.
2. Specifications: The specifications for the classes of drugs specified in
column 1 of the schedule shall be those specified against those drugs in column
2 of the schedule.
Class of drug |
Specifications to be
compiled with |
1. Drugs bearing
reference on the lebelling to any of the
publications specified under sub-clause t (ii)
of clause (z) of Section 3. |
Specifications given
in the publication referred to on the labelling. |
2. Drugs included in
the recent editions of any of the following
publications but not bearing any reference to
such publication :- (a) the international
Pharmacopoeia or such other specifications as
published by the World Health Organisation,
(b) the European Pharmacopoeia,
(c) the United States Pharmacopoeia,
(d) the British Pharmacopoeia,
(e) the British Pharmaceutical Codex.
(f) the United States .National Formulary. |
Specifications as
approved by the Registration Board for this
purpose and if no such approval is available the
specifications given in the said publications in
the same order of preference as given in column
1. |
3. Veterinary drugs |
Specifications as
approved by the Registration Board for this
purpose and if no such approval is available,
the specification given in the current edition
of British Veterinary Codex and, if a drug is
not included in the current edition and is
included in an earlier edition the specification
proscribed in that edition. |
4. Drugs other than
those falling under serial number 1, 2 or 3
above. |
Specifications as
approved by the Registration Board for
specification are available the ingredients and
their quantities displayed in the labelling
which shall be tested and analysed by the
Government Analyst or the Federal Drug
Laboratory or such other laboratory as may have
been specified to be the laboratory for the
purpose of sub-section (5) of section 22. |
5. Ophthalmic
preparations |
In addition to the
requirements, if any, set out above, ophthalmic
preparations shall meet the following
requirement:-
A-Ophthalmic Solutions and Suspensions;
Ophthalmic solutions and suspensions shall-- |
|
(a) be sterile
except in case of those ophthalmic solutions and
suspensions which are not specifically required
to comply with the test for 'Sterility' in the
Pharmacopocia; |
|
(b) contain one or
more suitable substances as preservatives to
prevent the growth of micro-organisms
Provided that solutions in used surgery shall
not have any preservative and be packed in
single dose containers; |
|
(c). be free from
foreign matter: |
|
(d) be contained in
bottles made of either neutral glass or soda
glass specially treated to reduce the amount of
alkali released when in contact with aqueous
liquids or in suitable plastic containers which
would not in any way be incompatible with the
solution and the droppers to be supplied with
the containers shall be made of neutral glass or
of suitable plastic material and when supplied
separately shall be packed in sterile cellophane
or other suitable packings; and |
|
B-- Ophthalmic
Ointment Ophthalmic Ointment shall-- |
|
(a) be sterile;
(b) be free from foreign matter. |