In a significant step towards overhauling the disposal practices of expired and unused drugs and with the aim of protecting human and animal health, preserving environmental integrity, and mitigating the escalating risk of Antimicrobial Resistance (AMR) in India, the Central Drugs Standard Control Organization (CDSCO) has issued a new set of comprehensive guidelines* in May 2025 emphasising strict compliance for all those involved in the supply chain management of drugs across the country for safe drug disposal in India.
Our blog will explore what these CDSCO guidelines mean for the pharmaceutical industry and how a robust compliance management solution can help stakeholders navigate this new era of accountability.
The Urgency Behind Proper Pharma Waste Management
Improper disposal of expired/unused drugs is detrimental to humans, animals, and the environment. Unchecked and rampant dumping of drugs has often been the leading cause of contamination of water supplies or local sources, posing a serious threat to the nearby communities and wildlife, therefore making it indispensable to have a mechanism for safe disposal of expired and unused drugs.
What are expired drugs?
"Expired drug" refers to drugs that have crossed the expiry date mentioned on the label.
What are unused drugs?
Unused drugs refer to the medications that have not been used by the individual for whom they were prescribed or purchased.
How were they being disposed of till date?
Previously, drug disposal rules in India were ambiguous, often just requiring retailers and wholesalers to store expired or unused medicines separately, as per the Drugs Rule, 1945. While the Revised Schedule 'M' under the Drugs Rule, 1945 provides the requirement of safe disposal of such drugs for the manufacturers, there was no comprehensive, industry-wide system for disposal followed uniformly across the production chain.
CDSCO, through these guidelines, has changed that by creating a formal, step-by-step framework which would hold all pharmaceutical stakeholders—from manufacturers to retailers—accountable for the entire lifecycle of a drug. This would ensure that expired or unused medicines are disposed of safely and correctly, preventing environmental contamination and minimizing the spread of antimicrobial resistance. The guidance document outlines various methods for disposal of expired/unused drugs, including:
- Landfill
- Waste immobilization (with proper encapsulation)
- Waste immobilization (inertization)
- Sewer Disposal (for a specific list of high-risk drugs),
- Incineration
- Chemical decomposition.
Understanding the new pharma reverse logistics pathway: What does the introduction of these guidelines mean for manufacturers/retailers/wholesalers/distributors?
The guidelines establish a reverse logistics pathway for expired and unused drugs. The guidance document proposes a standard procedure to be followed by various stakeholders for disposal of expired/unused drugs at different levels, which is as follows:
- Retailers are responsible for returning expired/unused drugs to suppliers or manufacturers within 30 days of expiry.
- Wholesalers/Distributors are required to accept returns from retailers and send them to the next supply chain level within 30 days. In case the wholesaler is directly an authorised agent of the manufacturer, and if he is authorized to dispose of expired/unused drugs on behalf of the manufacturer, then he can dispose of the expired/unused drugs in accordance with Biomedical Waste Management Rules 2016.
- Manufacturers now have the ultimate responsibility for handling and disposing of all expired or unused drugs, including those returned from the supply chain. They are required to accept all the expired/unused drugs from the persons (retailers or wholesalers) and dispose of them within six months of expiry, either on-site or through Pollution Control Board (PCB)-approved vendors.
- Government or Private Hospital/Government Agencies can directly dispose of the expired/unused drugs in accordance with Biomedical Waste Management Rules 2016. In case these hospitals/government agencies want to return the unused/expired drugs to the supplier, the same shall be returned within 30 days after their expiry to whom they have purchased them from.
Once implemented, all stakeholders also have to mandatorily maintain detailed records of drug disposals as per the format given in Annexure-A and Annexure-B of the guidelines with the requisite details. The records of such disposal must be made available for verification by the regulatory authority whenever required.
Strict protocols have been outlined for the handling of drugs prior to disposal, such as using yellow, non-chlorinated plastic bags or containers. Cytotoxic and radioactive drugs require separate, secure storage. Medications must be stored in secure, designated areas to prevent unauthorized access, leakage, or contamination. Vehicles used for transporting expired/unused drugs must comply with the Biomedical Waste Management Rules, 2016, and the Motor Vehicles Act, 1988. The dispensing, packaging, and transportation of radiopharmaceuticals shall comply with the relevant provisions of the Atomic Energy Act 1962 and the rules made thereunder.
The CDSCO's new guidelines are a significant step towards a more responsible and sustainable pharmaceutical ecosystem in India. They establish a robust framework that, when diligently implemented, will mitigate environmental pollution, enhance public safety, and contribute to the fight against antimicrobial resistance.
How a Compliance Management Solution Eases the Burden
The latest CDSCO drug disposal guidelines are a significant step towards a more responsible and sustainable pharmaceutical ecosystem in India. It establishes a sturdy framework that, when diligently implemented, would likely mitigate environmental pollution, enhance public safety, and contribute to the fight against antimicrobial resistance. For businesses, this new level of detail and accountability requires a more structured approach towards managing compliances, especially in a regulatory environment like India.
Manually tracking these compliance obligations is not just inefficient but fraught with risks. Implementing a compliance management solution, such as Lexplosion Solutions' Komrisk, can prove to be a strategic move. It provides the automated and centralized compliance library, centralised documentation, automatic updates, alerts, and escalations needed to navigate these regulatory changes, ensuring your organization not only meets its legal obligations but also operates with the confidence that comes from being fully compliant.
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