Last Updated on May 20, 2025 by The Health Master
Expired Medicines
What’s in a Disposal? For many—and many hospitals—nationwide, how to dispose of unused and expired medicines has been a complicated question with a troublesome answer at best, potentially fatal at worst.
But soon, people will have answers.
The Central Drugs Standard Control Organization of India (CDSCO)—India’s drug regulatory authority—is coming up with guidelines for people and hospitals on how to dispose of unused and expired medicines.
Why the New Guidelines?
The new guidelines and standard operating procedures were arrived at by an expert committee operating under the purview of Drugs Consultative Committee (DCC) of CDSCO.
The 92nd meeting of the Drugs Technical Advisory Board (DTAB) revealed that board members were briefed on the guidance document from the expert committee.
The minutes of this landmark meeting reveal that after much debate on the subject and careful consideration, the DTAB—the central government’s highest advisory board on drug control—”recommended that CDSCO may put the guidance document on its website and also circulate it to all State/UT Drugs Controllers.”
Furthermore, as it has national relevance, the board recommended that “the guidance document may also be shared with the Directorate General of Health Services (DGHS) office for its circulation to all medical colleges.”
Guidance Comes After a Long Established Need
This type of guidance was necessary after a long-established need regarding how people should not take random steps to throw out unused and expired medicines at home or in the hospital.
Therefore, the DCC, which is the internal advisory committee to the CDSCO, constituted a sub-committee in October 2020 to evaluate the need and give a structured solution.
Therefore, after much research and deliberation, the sub-committee presented its report along with the proposed guidance document in the 64th DCC meeting in June 2024.
As per the DCC, while it largely agreed with the submitted report, additional scrutiny of proposed techniques is needed for the layperson in order to understand and implement before the report is finalized and published.
Indian Guidelines Usher in Global Standards for Compliance of Safe Disposal
Furthermore, these Indian guidelines come from compliance with global standards and recommendations.
As per the prepared document, it is consistent with numerous international guidelines, including WHO and USFDA, so India’s efforts collide with many international safe pharmaceutical waste disposal efforts.
New Drug Manufacturing Guidelines
Whereas returns for patients are now mandated, the CDSCO will encourage drug waste also in the manufacturing facility.
According to updated Schedule M (Good Manufacturing Practice) guidelines, starting in 2024, drug manufacturers will be legally bound to have proper storage spaces for disposal agents and any in-house medicines that are non-usable or non-recallable.
This is preventative to ensure contamination does not happen at the source and medicines remain regulated.
Study Prompts AIIMS Letter, CDSCO Takes Action
The need for injectable waste was championed by a letter received by CDSCO from AIIMS Delhi.
A study was cited in the correspondence that determined antimicrobial medicines and other Active Pharmaceutical Ingredients found their way into the drinking water system for NCT and beyond.
The second biggest contributor to this alarming contamination comes from discarded and unused medicines, which are thrown away into landfills.
Medicines Detected in Water
To make matters worse, as per the presentation from the 58th DCC, it’s worse than you know.
The research evaluated surface water testing of 28 different medicines across therapeutic categories.
Detected were antimicrobials, for instance, and other APCs, and even wells in Delhi’s aquifers that exceeded 0.1 micrograms per liter (μg/L).
Impact of Detected Levels on the Environment and Human Health
While the WHO does not include pharmaceuticals or antimicrobials in nationals and international standards for drinking water quality recommended levels, these levels higher than 0.1 μg/L (100 nanograms per liter) are included in sufficient numbers in environmental studies as correlated with the emerging phenomenon of antimicrobial resistance, not to mention adverse environmental impacts.
So the CDSCO’s eventual recommendations are a start.
Q. What happens if unused and expired medicines are not disposed of properly?
A. They get into the hands of children and animals. They get stolen to be used or abused by other people. They contaminate our soil and drinking water. They become subtherapeutic for those that need them when they shouldn’t be.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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