February 7, 2023
DHAKA – The cabinet yesterday approved the draft of the Drugs and Cosmetics Act-2023 keeping provisions for imposing fines for sale of medicines, including antibiotics, without registered doctors’ prescriptions, and handing out a maximum punishment of life term for manufacturing adulterated medicines.
The proposed law also seeks to make licensing mandatory to regulate the manufacturing and marketing of cosmetics.
Manufacturers and marketers of cosmetics will have to have licence from the Directorate General of Drug Administration (DGDA).
The approval came at a cabinet meeting at the Prime Minister’s Office, with Prime Minister Sheikh Hasina in the chair.
Meanwhile, the PM during an unscheduled discussion in the meeting directed the authorities concerned not to destroy any land from where three crops are harvested a year.
Briefing reporters at the Secretariat after the meeting, Cabinet Secretary Md Mahbub Hossain said the premier has given a clear directive that no land on which three crops grow a year can be damaged.
“No project can be taken up involving such land. Rather, such land will have to be saved.”
He said the directive will be applicable to all public and private development works. The government from now on will regularly monitor the matter of saving land on which three crops grow, he added.
The directive came as different ministries received proposals for using such type of land for development projects.
Replying to a question, Mahbub said the Cabinet Division will issue orders in this regard.
There were five agendas for discussions in yesterday’s cabinet meeting.
Mahbub said the issues of clinical trials and side effects of medicines have been incorporated in the draft of the Drugs and Cosmetics Act-2023. “If a medicine is found to be harmful, its registration will be cancelled.”
An accused will be handed a maximum punishment of life term for hoarding medicines and creating artificial crisis in the market to make an extra profit, and manufacturing, hoarding and marketing counterfeit medicines, he added.
The cabinet secretary said an accused will be awarded a maximum 10 year’s rigorous imprisonment or fined up to Tk 10 lakh for manufacturing, marketing, selling and displaying medicines without licence or violating conditions of the licence.
“In the current law, there is no provision for quality testing for the lot release of vaccines. This has been incorporated in the [proposed] act.”
Mahbub said the matters of monitoring and controlling the use of antibiotics were included in the proposed law as the prevention of antimicrobial resistance (AMR) has emerged as a big challenge.
He said the proposed law stipulates that if medicines, including antibiotics, are sold without prescriptions, the seller would be fined a maximum of Tk 20,000. “There is a list of medicines for sale over the counter.”
The cabinet secretary said as per the proposed act, “medical devices” will be considered medicine.
He said there are now two drug-related laws — Drugs Act-1940 and Drugs (Control) Ordinance-1982 and those deal only with medicines. “Cosmetics have been covered in the proposed law.”
The meeting also gave the final nod to the draft of the Copyright Act-2023, keeping provisions for punishment to check piracy.