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Drugs (Specifications) Rules, 1978
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.
SCHEDULE
Specifications for Drugs
SCHEDULE
Specifications for Drugs
| 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-- |
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(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; |
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(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; |
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(c).
be free from foreign matter: |
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(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 |
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B--
Ophthalmic Ointment Ophthalmic Ointment shall-- |
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(a)
be sterile;
(b) be free from foreign matter. |
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