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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