“The need was felt for safe and proper disposal of expired/unused medicines/drugs for protecting the environment and public health,” a government official aware of the development told ET.
The document is in the final stages of completion. It will include procedures to be followed for disposal, collection, storage and transportation of expired and unused drugs.
Improper disposal of medications that have crossed the expiry date mentioned on the label or not used by the individual for whom they were prescribed and purchased may be hazardous to public health, animal health and environment, officials said.
The recently notified Schedule M under Drug Rules prescribed the requirements for manufacturers for proper and safe storage of waste material awaiting disposal.
The guidance document in works has been prepared to provide the best practices that may be followed for safe and proper disposal of expired/unused drugs, the official cited above said.The document has been prepared keeping in view various international guidelines including those issued by the World Health Organisation (WHO) and the US Food and Drug Administration (USFDA). The Biomedical Waste (Management and Handling) Rules, 2016, have also been considered, officials said.The Central Drugs Standard Control Organisation (CDSCO) had received a letter from researchers, referring to an article regarding a study aimed to assess the extent of exposure of active pharmaceutical compounds (APCs) in the hydrologic cycle in and around New Delhi.
The study stated the role of ecological exposure due to the disposal of unused and expired pharmaceutical compounds into landfills and indicated that un-segregated drug disposal could be a reason for the emergence of drug resistance with special reference to antibiotics.
Discussions to make sure proper disposal of these medications have been going on for long.
The guidance documents will have methods for disposal of expired/unused medicines in landfills. It will also specify ways to dump antineoplastic drugs, officials said.
