CDSCO Issues Guidelines for Disposing Expired and Unused Drugs Safely

Key Highlights:-

• CDSCO issues national guidelines for the safe disposal of expired and unused medicines
• Multiple disposal methods recommended, including incineration and chemical decomposition
• 17 high-risk medicines approved for limited flushing to avoid household exposure risks

The Central Drugs Standard Control Organisation (CDSCO) has uncovered a detailed guidance document focused on the safe disposal of unused and expired medicines. This move purposes to control the growing risks stood by improper drug disposal, including the rising threat of antimicrobial resistance (AMR).

The newly released document provides a framework for all stakeholders, ranging from pharmaceutical manufacturers to the general public on how to manage and discard expired medicines responsibly. In a formal communication to State and Union Territory drugs controllers.

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, stressed local authorities to actively promote and implement these guidelines, highlighting their role in fighting AMR across the country.

The guidance explores various disposal methods such as encapsulation, inertization, incineration, and sewer disposal for a limited list of medicines, chemical decomposition, and more. Each method is matched to specific types of waste, with safety, legal compliance, and environmental protection as primary considerations.

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Significantly, the document outlines structured roles and responsibilities for different levels in the pharmaceutical supply chain for manufacturers, wholesalers, distributors, stockists, and retailers, all of them must follow to designated timelines under the Biomedical Waste Management Rules, 2016. It also includes detailed procedures for both public and private hospitals, government institutions, and drug inspectors managing medicine samples.

For certain high-risk medicines, the guidance allows limited disposal through flushing and adds a listing of 17 specific drugs considered to be safe for such practices to protect households, pets, and children from accidental exposure.

The CDSCO said, “The guidelines are a step forward in mitigating environmental pollution, reducing public health risks, and tackling the challenge of antimicrobial resistance, and they provide clear, actionable steps for ensuring that expired and unused drugs are disposed of in a way that is legal, safe, and responsible.”