PART
II
Administration
Cosmetic
Devices and Drugs Technical Advisory Committee
18.(1)
There shall be a Committee which shall be called the cosmetics, Devices
and Drugs Technical Advisory Committee (hereinafter referred to as the
"Committee") consisting of -
(a)
the Director of Health Services who shall be the Chairman of the
Committee;
(b)
the Assistant Director of Health Services in charge of cosmetics , Device
and Drugs control Administration who shall be the Secretary of
the committee;
(c)
the Professor of pharmacology of the University of Colombo;
(d)
the pharmacologist of the Medical Research Institute;
(e)
the Chairman of the State Pharmaceuticals Corporation;
(f)
the Superintendent of the State Medical Stores;
(g)
the Government Analyst or any officer nominated by him;
(h)
the officer in charge of the Drugs Quality Control Laboratory;
(i)
a consultant physician nominated by the Minister;
(j)
a consultant surgeon nominated by the Minister;
(k)
a representative of the Pharmaceutical Manufacturers' Association nominated
by that Association;
(1)
a representative of the Bureau of Ceylon Standards, nominated by the
Minister in charge of the subject of Industries;
(m)
a representative of the Pharmaceutical Society of Sri Lanka nominated
by that Society;
(n)
a representative of the Sri Lanka Medical Association nominated by that
Association; and
(o)
a representative of the Independent Medical Practitioners' Association
nominated by that Association.
(2)
Every member of the Committee nominated under paragraphs (i), (j), (k),
(1), (m), (n) or (o) of subsection(1) shall, unless he earlier vacates
office by resignation, death or removal, hold office for a period of
three years from the data of nomination and shall be eligible for renomination.
(3)
Every member of the Committee, other than the members referred to in
subsection (2), shall cease to be a member of the Committee on his ceasing
to hold office which qualified him to be a member of the Committee.
(4)
The Committee may discharge its functions notwithstanding any
vacancy among its members.
(5)
Five members of the Committee shall constitute a quorum for any meeting
of the Committee.
(6)
Subject to the provisions of this Act, the Committee may regulate its
own procedure in regard to its meetings and the transaction of
business at the meetings.
Duties
of the committee
19.
(1) It shall be the duty of the Committee to advise the Minister on
matters arising out of the administration of this Act and to carry out
other functions assigned to it under this Act.
(2)
The Committee may appoint such sub-committees as it deems fit to exercise
such powers or perform such duties as may, subject to such conditions,
if any, as the Committee may impose, be delegated to them by the Committee,
and may appoint to those sub-committees persons who are not members
of the Committee.
Cosmetics
Devices and drugs Authority
20.
(1) For the purposes of this Act, the Director of Health Services shall
be the Cosmetics, Devices and Drugs Authority (hereinafter referred
to as the "Authority").
'(2)
Every drug shall be registered with the Authority.
(3)
The Director of Health Services may with the approval of the Minister
delegate all or any of his powers
as the Authority under this Act to any person by name or office.
Authorised
Officers.
21.
(1) The Minister may approve any Superintendent of Health Services,
any Medical Officer of Health, any Public Health Inspector, any Food
and Drugs Inspector and any Drugs Inspector to be an Authorized Officer
for the purposes of this Act.
(2)
Every Authorized Officer shall exercise the powers of a police officer
in terms of the Code of Criminal Procedure Act, No. 15 of 1979, for
the purpose of discharging his functions under this Act.
Powers
of Authorised Officers.
22.(1)
An Authorized Officer may, for the performance of his duties and the
exercise of his powers-
(a)
at any reasonable time enter any place where he believes any article
is manufactured, prepared, packaged, preserved or stored and examine
any such article and take samples thereof, and also examine anything
that he believes is used for the manufacture, preparation, preservation,
packaging or storing of such article;
(b)
open and examine any receptacle or package that he believes to contain,
any article;
(c)
where the Authorized Officer is a Superintendent of Health Services
or a Medical Officer of Health, examine any books, documents or other
records found in any place mentioned in paragraph (a).that he believes
to contain any information relevant to the carrying into execution or
the enforcement of this Act with respect to any article and make copies
thereof or take extracts there- from ; and
(d)
seize and detain for such time as may be necessary any article by means
of or in relation to which he believes any provisions of this Act or
regulations made thereunder have been contravened.
(2)
For the purposes of this section and section 23 "article"
means-
(a)
any cosmetic, device or drug;
(b)
anything used or capable of being used for the manufacture, preparation,
preservation, packaging or storing of any cosmetic, device or drug;
and
(c)
any labelling or advertising material.
(3)
An Authorized Officer acting under this section shall if so required,
produce his authority.
(4)
The owner or person in charge of a place entered by an Authorized Officer
in pursuance of subsection (1) and every person found therein shall
give the Authorized Officer all reasonable assistance in his power and
furnish him with such information and such samples as he may require.
(5)
No person shall obstruct any Authorized Officer acting in the exercise
of his powers under this Act or any regulations made thereunder.
(6)
If any Authorized Officer applies to obtain samples of any cosmetic,
device or drug exposed for sale, and the person exposing the cosmetic,
device or drug refuses to sell to the Authorized Officer such quantity
thereof as he may require or refuses to allow that officer to take the
quantity which he is empowered to take as samples the person so refusing
shall be deemed for the purposes of subsection (5) to have obstructed
an Authorized Officer.
(7)
No person shall knowingly make a false or misleading statement either
orally or in writing to any
Authorized- Officer engaged in the exercise of his powers under this
Act or any regulations made thereunder
(8)
No person shall remove or alter, tamper or otherwise interfere in any
manner with any article seized under this Act by an Authorized Officer
without the authority of the Authorized Officer.
(9)
Any article seized under this Act may at the option of the Authorized
Officer be kept or stored in the building or place where it was seized
or may at his discretion be removed to any other place.
(10)
An Authorized Officer shall forthwith inform the Authority of any seizure
made under this Act.
Procedure
in respect of articles seized.
23.
(1) Where an article in. respect of which an offence has been committed
is seized under this Act by an Authorized Officer, such article may
be destroyed or otherwise disposed of as the Authority may direct where
the Authority is satisfied that there has been a contravention of any
of the provisions of this Act or any of the regulations made thereunder
and where the owner of such article or the person in possession of such
article at the time of seizure consents in writing to the destruction
of such article.
(2)
Where the owner or person in possession of such article does not consent
in writing to the destruction of such article, the Authority-
(a)
shall release such article if he is satisfied that the provisions of
this Act or any regulation made thereunder in respect of such
article have not been contravened; or
(b)
shall, where he is satisfied that there has been a contravention of
any of the provisions of this Act or
regulations made thereunder, forthwith, with notice to such owner or
person in possession of the article
inform the Magistrate's Court having jurisdiction over the area in which
the offence was committed
of the seizure of the article in respect of which the offence was committed.
(3)
On information furnished to the court under subsection (2) (b) such
court shall-
(a)
if, after, trial, it finds the owner or person to possession of the
article guilty of contravening any of the provisions of this Act or
regulations made thereunder, order that such article be forfeited to
the Authority to be disposed of as the court may direct:
Provided,
however, that where the offender is not known or cannot be found such
article shall be forfeited to the Authority without the institution
of proceedings in respect of such contravention; or
(b)
if, after trial, it finds the owner or person in possession of
the article not guilty of contravening any of the provisions of this
Act or regulations made thereunder, order that such article be released
to such owner or person in possession.
Analysis
24.(1)
An Authorized Officer shall submit any cosmetic, device or drug seized
by him or any portion thereof or any sample taken by him, unless destroyed
under section 23 (1), to the Approved Analyst for analysis or examination.
(2)
Where the Approved Analyst has made an analysis or examination of the
cosmetic, device or drug submitted to him under subsection (1),
he shall issue a certificate or report to the Authority setting out
in that certificate or report the results of his examination or analysis.
(3)
For the purposes of this section the Approved Analyst includes an Additional
Approved Analyst.
Approved
Analyst
25.(1)
For the purposes of this Act and the regulations made thereunder the
Government Analyst shall be the Approved Analyst.
(2)
Notwithstanding the provisions of subsection (1), the Minister may approve
any person to be an Additional Approved Analyst. Notification of the
approval shall be published in the Gazette.
(3)
No person shall be approved as an Additional Approved Analyst-
(a)
if he does not possess the prescribed qualifications; or
(b)
if that person is engaged directly or indirectly in any trade or business
connected with the manufacture, import, sale or distribution of
cosmetics, devices or drugs.
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