Drugs and Cosmetics Act, 2023 (Act No. 29 of 2023).

This Act regulates the manufacture, import, export, buying and selling, stocking, storage, display, distribution and quality control of drugs and cosmetics in Bangladesh. The existing Directorate General of Drug Administration shall continue as if established under this Act. Its functions and powers are laid down. The Act establishes the National Drug Control Laboratory for the purpose of quality control of drugs and Drug Testing Laboratories in different parts of Bangladesh. Chapter III of the Act makes provisions for licensing for manufacture, sale, stocking, distribution or display for the purpose of sale of drugs and the procedure to be followed for obtaining such licence. It requires establishments to follow Good Practices guidelines of the World Health Organization. Chapter IV provides for drug registration, market authorization and related provisions. Chapter VI prohibits sale of substandard, misbranded, counterfeited and adulterated drugs. Chapter VII prohibits import and export of drugs without obtaining a licence. Chapter VIII requires presence and supervision of qualified person in manufacturing process of drugs as well as sale of drugs. Chapter IX provides for appointment of inspectors and lays down their powers. Chapter XI contains the offences and penalties. Chapter XII deals with clinical trials, pharmacovigilance and vaccines.