Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on June 16, 2025 by The Health Master
Expired and Unused Drugs
The Central Drugs Standard Control Organisation (CDSCO) issued detailed guidelines on May 26, 2025, for the safe disposal of expired and unused drugs.
Why Proper Drug Disposal Matters
Expired drugs, which have passed their labeled expiry date, and unused drugs, medications not consumed by the person they were prescribed for, can create serious problems if not disposed of correctly.
If proper disposal is not done, it may lead to:
- Environmental Contamination
- Public Health Risks
- Antimicrobial Resistance (AMR)
- Animal Health risk
This guidance document was issued after discussions in the 58th Drugs Consultative Committee (DCC) meeting and approved by the Drugs Technical Advisory Board (DTAB).
What are Expired and Unused Drugs
- Expired drugs are those that have passed their expiry date, and they are ineffective or unsafe.
- Unused drugs include drugs that are not used by individuals due to some reasons.
The CDSCO guidelines align with the Drugs and Cosmetics Act, 1945, and the Biomedical Waste Management Rules, 2016.
Key Methods of disposal of drugs
There are several methods for disposing of expired and unused drugs. Details are given in Annexure C.
- Landfill:
- Waste Immobilization
- Sewer Disposal
- Incineration
- Chemical Decomposition
- Special Handling for Radioactive and Controlled Drugs
Procedures for Stakeholders
The CDSCO guidelines give specific procedures for stakeholders for the safe disposal of expired and unused drugs.
Retailers (Medical Stores)
Return expired and unused drugs to suppliers or manufacturers within 30 days of expiry. If the supplier is inaccessible, dispose of drugs as per Biomedical Waste Management Rules, 2016.
Maintain a record of these disposals in Annexure A with details such as name of drug, batch number, date of expiry, and reason for the disposal.
Wholesalers/Distributors/Stockists
Accept all the returns from retailers and send the same to the next supply chain within 30 days per level. Authorized agents can dispose of these drugs on behalf of manufacturers as per Biomedical Waste Management Rules.
Maintain a record of these disposals in Annexure A with details such as name of drug, batch number, date of expiry, and reason for the disposal.
Manufacturers
Accept returned drugs and dispose of them within six months of expiry, either on-site or through a Pollution Control Board (PCB)-approved vendor.
Maintain records as per Annexure B, including quantities distributed, returned, and disposed of.
Hospitals and Government Agencies
Dispose of drugs directly per Biomedical Waste Management Rules or return them to suppliers within 30 days of expiry.
Maintain Annexure A records and disposal certificates for regulatory verification.
Drugs Inspectors
Samples: Dispose of standard-quality expired sample parts as per Biomedical Waste Management Rules. Unexpired standard-quality samples may be supplied to government institutions.
Proper handling during collection, storage, and transportation is critical to prevent misuse or environmental harm.
Collection: Use yellow, non-chlorinated plastic bags or containers for expired and unused drugs. Cytotoxic and radioactive drugs require separate, secure storage.
Storage: Store in designated areas, with controlled substances and radioactive drugs in secure, labeled containers.
Transportation: Use vehicles compliant with Biomedical Waste Management Rules and the Motor Vehicles Act, 1988. On-site transport uses dedicated trolleys or carts, which must be autoclaved or disposed of properly.
Disposal by the General Public
Drug Take-Back Programs: State Drugs Control Departments and Chemists’ Associations can establish collection sites for the public to drop off expired and unused drugs.
These are disposed of by licensed agencies under Biomedical Waste Management Rules.
Certain high-risk medications (e.g., fentanyl, morphine, oxycodone) should be flushed down the sink or toilet to prevent accidental misuse. Annexure D lists 17 such drugs.
Precautions: Avoid flushing large quantities of non-listed drugs to prevent environmental damage.
Consult local pharmacies or take-back programs for other medications.
Download Annexures
Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana
