The Drugs Control Ordinance, 1982

 Drug Control Committee (Section 4)

(1) The Government shall constitute a Drug Control Committee consisting of
 a Chairman and such other members as it may appoint from time to time.
(2) The Committee shall perform such functions as are specified in this
Ordinance.

 Cancellation or suspension of registration (Section 6)

(1) The licensing authority may
 cancel the registration of any medicine if such cancellation is recommended
by the Committee.
(2) The committee will evaluate
 each drug registered before the ordinance is enacted and
 each drug may be manufactured or imported after such initiation to
determine safety, efficacy and usefulness.
(3) If on such evaluation the Committee finds that any such medicine is not
safe, efficacious or useful,
 it may recommend to the licensing authority for cancellation of registration
of the medicine.
(4) If the licensing authority is satisfied that the drug is substandard, it may
suspend registration of such drug until it is satisfied that the drug has achieved
its quality.
 Appeal (Section 6A)
(1) Those who are unhappy with an order or decision made by the licensing
authority under sections 5 and 6 may,
 within 1 month from the date of making of the order or decision,
 prefer an appeal to the Appellate Authority appointed under sub-section
(2).
(2) The Government shall, for the purpose of this section,
 appoint an Appellate Authority consisting of a Chairman and such number
of other members as it may think fit.
(3) The Appellate Authority will give its decision
 on the appeal after giving the opportunity of hearing to the concerned
party.
(4) The decision of the Appellate Authority
 shall be final and
 shall be binding upon the parties and
 shall not be called in question before any Court or authority.

 Prohibition of Manufacture, etc., of certain medicines (Section 8)

(1) After the enactment of this Ordinance, the registration or license of all the
drugs mentioned in the Schedule will be
 revoked and
 no such drug may be manufactured, imported, distributed subject to the
provisions of sub-section (2)
(2) Notwithstanding anything contained in sub-section (1),
(a) the medicines specified in Schedule I shall be
 destroyed within 3 months from the date of commencement of this
Ordinance;

(b) The drugs referred to in Schedule II may be

  manufactured or sold for 12 months from the date of enactment of this
Ordinance and
 thereafter their production, stock, exhibition and sale shall be permitted
only if they are registered after a change in their formulation as directed
by the Licensing Authority;
(c) The drugs referred to in Schedule III may be
 manufactured, imported, distributed and sold for 18 months after the
commencement of this Ordinance and
 thereafter no such manufacture, import, distribution, stock, exhibition or
sale of such drugs shall be allowed.
(d) The drugs referred in Schedule IV may be
 manufactured, distributed and sold for 18 months after the enactment
of this Ordinance and
 thereafter their production, distribution, stock, exhibition and sale will
be permitted only if they are re-registered with the Licensing Authority.
Provided that the import of new raw materials for the manufacture of certain
drugs in Schedule III and Schedule IV shall not be permitted.
 Restriction on import of certain pharmaceutical raw material (Section 9)
(1) In order to manufacture any medicine listed in one of the Schedules, no
pharmaceutical raw material is allowed to be imported.
(2) No drugs, semi-finished bulk drugs or pharmaceutical raw materials may be
imported without the prior approval of the Licensing Authority.
(3) The licensing authority may award an approval under sub-section (2) on
such conditions as it deems fit to specify:
Provided that in case of awarding approval to import any finished medicine,
 such medicine shall be registered for sale under the same brand name in
any of the countries specified under sub-section (1A) of section 5.

 Manufacture of drugs under licensing agreement etc. (Section 10)

Subject to the approval of the licensing authority,
(a) a foreign manufacturer may be allowed to manufacture
 any drug under licensing agreement with any manufacturer in Bangladesh if
the drug is its research product and
 is registered under the same brand name in any of the countries specified
under sub-section (1A) of section 5;
(b) a manufacturer in Bangladesh may be allowed to manufacture
 any drug under any written contract with any pharmaceutical
manufacturing plant in Bangladesh.

 Control of advertisement and claims in respect of drugs (Section 14)

Without the prior approval of the licensing authority, no person shall
 publish or take any part in the publication of any advertisement which
relates to the use of any drug or contains any claim in respect of therapies
or treatment
Explanation:
The term "advertisement" includes
 any notice, circular, or other document posted in a public place or on public
transportation, or published in a newspaper or magazine,
 any announcement made orally or through any medium that produces or
transmits light or sound, as well as any business circular, insert, or level.

 Prescription of unregistered medicine prohibited (Section 14A)

(1) No Physician shall prescribe for any patient any medicine which is not
registered under this Ordinance.
(2) Nothing in this section shall apply to the prescription of any drug which is-
(a) manufactured in a foreign country after testing its efficacy and usefulness;
(b) imported with the permission of the licensing authority for the purpose of
examination, test, or analysis or for personal use.
 Penal sections
 Penalty for manufacture, etc., of certain drugs (Section 16)
Whoever manufactures, imports, distributes, stocks, exhibits, or sells-
(a) any medicine which is not registered under this Ordinance, or
(b) any medicine that doesn't follow the provision in Section 8,, or
(c) any drug that has been changed, mislabeled, faked, or copied,
Shall be
 punishable with rigorous imprisonment for a term which may extend to 10
years, or with a fine which may extend to 2 lakh Taka, or with both, and
 any implements used in the manufacture or sale of such medicine or drug
may, by order of the Drug Court, be forfeited to the Government.

 Penalty for manufacture, stock, or sale of sub-standard drugs (Section 17)

Whoever manufactures, stocks, or sells any sub-standard drug shall be,
 Punishable with rigorous imprisonment for a term which may extend to 5
years, or with a fine which may extend to 1 lakh Taka, or with both.

 Penalty for unauthorized import of drugs (Section 18)

Whoever imports any drug or pharmaceutical raw material without the prior
approval of the licensing authority shall be,
 Punishable with rigorous imprisonment for a term which may extend to 3
years, or with a fine which may extend to 50 thousand Taka, or with both
and
 such drug or raw material may, by order of the Drug Court, be forfeited to
the Government.

 Penalty for sale of medicine or import or sale of pharmaceutical raw

material at a higher price (Section 19)
Whoever sells any medicine or imports or sells any pharmaceutical raw
material at a higher price than the maximum price fixed by the Government
under section 11 shall be,
 Punishable with rigorous imprisonment for a term which may extend to 2
years, or with a fine which may extend to 10 thousand Taka, or with both.

 Penalty for theft, etc., of Government drugs (Section 20)

Whoever commits theft in respect of any drug in any Government store,
hospital, clinic, or health center or sells any such drug or keeps in his
possession any such drug for sale shall be,
 Punishable with rigorous imprisonment for a term which may extend to 10
years, or with fine which may extend to 2 lakh Taka or with both.

 Penalty for illegal advertisement and claims (Section 21)

Whoever doesn't follow the provision of section 14 shall be,
 Punishable with rigorous imprisonment for a term which may extend to 3
years, or with a fine which may extend to 2 lakh Taka, or with both.

 Offenses by companies (Section 21A)

1. As soon as a company violates this Ordinance, everyone who was in charge
of or responsible for the company's day-to-day activities is presumed guilty
and can face criminal charges and punishment.
If he establishes that the offense was committed without his knowledge or that
he exercised all necessary duty to prevent the commission of such violation, he
will not be responsible to any punishment stipulated in this Ordinance.

(2) Notwithstanding anything contained in sub-section (1),

 Any offense committed by a company under this Ordinance that is proven
to have been committed with the consent or connivance of any director,
 manager, secretary, or other officers of such company shall also be deemed
to have been committed and punished by such officers as well.

 Cognizance of offenses (Section 22)

Notwithstanding anything contained in the Code of Criminal Procedure, 1898,
(a) an offense punishable under this Ordinance shall be non-cognizable;
(b) No court other than a Drug Court can try an offense that is punishable
under this ordinance;
(c) A Drug Court can't look into a crime that is punishable by this Ordinance
unless the licensing authority or an officer with permission from him makes a
written report.

 Drug Courts (Section 23)

(1) The government can set up
 as many drug courts as it thinks are needed by putting a notice in the
Official Gazette.
If it sets up more than one drug court,
 it must say in the notice within which each one has jurisdiction under this
ordinance.
(2) A Drug Court is made up of a Sessions Judge or a former Sessions Judge,
who is appointed by the Government.
(3) A Drug Court meets wherever the government tells it to.
(4) A Drug Court can hand down any sentence allowed by this ordinance, and it
has all the powers given to a Court of Session with original jurisdiction by the
Code of Criminal Procedure of 1898.
(5) A Drug Court shall not, merely by reason of a change in its composition,
 be bound to recall and rehear any witness who has given evidence, and
 may act on the evidence already recorded by or produced before it.
(6) A Drug Court must follow the procedure set out in the Code of Criminal
Procedure, 1898
 for the trial of summons cases by Magistrates in all cases where this
Ordinance doesn't say how to do something.
(7) If the prosecution asks,
 a Drug Court can try an offence of this Ordinance quickly according to
sections 262 to 265 of the Code of Criminal Procedure, 1898.
(8) The High Court Division is the place to go if you don't agree with what a
Drug Court says.