This Ordinance was made and promulgated by the Ministry of Law and Land Reforms (Law and Parliamentary Affairs Division) of the People’s Republic of Bangladesh on 11th June, 1982 as Ordinance No VIII of 1982. The provisions of this Ordinance are additional to, and not derogatory of, the Drugs Act, 1940. Through this Ordinance, the government has constituted different committees; some of these are as follow:

(i) A Drug Control Committee consisting of a Chairman and a varied number of members appointed by the government from time to time to perform such functions as are specified in the Ordinance, and

(ii) a National Drug Advisory Council consisting of a Chairman and such other members as the government may appoint from time to time.

Under this Ordinance following are maintained strictly.

(i) No medicine of any kind can be manufactured for sale or be imported, distributed or sold unless it is registered with the licensing authority;

(ii) No drug or pharmaceutical raw material can be imported into the country except with the prior approval of the licensing authority;

(iii) The licensing authority cannot register a medicine unless such registration is recommended by the Drug Control Committee;

(iv) The licensing authority may cancel the registration of any medicine if such cancellation is recommended by the Drug Control Committee on finding that such a medicine is not safe, efficacious or useful;

(v) The licensing authority is also empowered to temporarily suspend the registration of any medicine if it is satisfied that such a medicine is substandard;

(vi) The government may, by notification in the official gazette, fix the maximum price at which any medicine may be sold and at which any pharmaceutical raw material may be imported or sold;

(vii) No person is allowed to manufacture any drug except under the personal supervision of a pharmacist registered in Register ‘A’ of the Pharmacy Council of Bangladesh;

(viii) No person, being a retailer, is allowed to sell any drug without the personal supervision of a pharmacist registered in any Register of the Pharmacy Council of Bangladesh; and (ix) the government may, by notification in the official Gazette, establish Drug Courts as and when it considers necessary.

Other Provisions of Drugs Control Ordinance:

There are provisions, under this Ordinance, of different kinds of penalties (fines, imprisonment, withdrawal of registration, cancellation of licenses, etc) for defaulters of any of the above regulations.

The National Drug Advisory Council advises the government on measures to be adopted for the implementation of the national drug policy; on measures to be taken for the promotion of local pharmaceutical industries and the production and supply of essential drugs for meeting the needs of the country; on matters relating to the import of drugs and pharmaceutical raw on materials; and measures for the co-ordination of the activities of the various ministries, agencies and persons dealing with the manufacture, import, distribution, and sale of drugs.