Disposal of expired and unused medicines: Health Minister apprises parliament
New Delhi: Through a recent reply, the Minister of State for Health and Family Welfare (MOS Health) informed the Rajya Sabha about the rules for disposal of date expired and unused drugs.
Responding to questions raised in Rajya Sabha, MOS Health stated that the manufacture, sale and distribution of drugs in the country is regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder through a system of licensing and inspection. Licenses for manufacture, sale and distribution of drugs are granted by the State Licensing Authorities (SLAs) appointed by respective State Governments.SLAs are legally empowered to take stringent action against violation of provisions of the Act and Rules.
"Licensee is required to comply with all the conditions of licence. One of the conditions of licence states that no drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper," he stated
" Provided that any such drug in respect of which the licensee has taken steps with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, maybe stocked after the date of expiration of pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same shall be stored separately from the trade stocks and all such drugs shall be kept in packages or cartons, the top of which shall display prominently, the words -Not for sale." he further informed
One of the conditions of manufacturing license is that the manufacturing site is required to comply with the requirements of Good Manufacturing Practices prescribed in Schedule M of the Drugs & Cosmetics Rules, 1945. As per Schedule M, the disposal of sewage and effluents (Solid, liquid and gas) from the manufacturing factory shall be in conformity with the requirements of the Environment Pollution Control Board.
" As per the Bio-Medical Waste Management Rules, 2016, discarded medicines shall be either sent back to the manufacturer or disposed of by incineration. Pollution control boards in States and UTs are implementing the Biomedical Waste Management Rules 2016." said the minister
The Minister was responding to MP Kumar Ketkar who questioned whether Government has framed any rules for disposal of date expired and unused drugs and whether there is a Drug Take-Back programme or guidelines. The MP further asked whether Government is considering creating awareness on issues like medicines thrown in dustbin, toilets, sinks etc. are polluting environments and are coming back to us through some or other way despite knowing very well that one of the reasons for antibiotic resistance is improper disposal of antibiotics and that whether the government has any plan to develop policy and implement it with adequate funding support.