CDSCO Releases Guidance for Safe Disposal of Expired and Unused Medicines

CDSCO Releases Guidance for Safe Disposal of Expired and Unused Medicines. The Central Drugs Standard Control Organisation (CDSCO) has taken a significant step to safeguard public health and the environment by releasing a detailed guidance document on the safe disposal of expired and unused medicines. This document, issued on 26th May 2025 by the Director General of Health Services, offers comprehensive procedures and methods for various stakeholders to follow, ensuring compliance with laws and minimizing environmental harm. Let us explore the background, objectives, and key components of this guidance in detail.
Background of the CDSCO Initiative
The guidance document from CDSCO stems from a growing concern about the improper disposal of pharmaceutical waste. Researchers brought to CDSCO's attention the serious ecological risks posed by expired and unused medicines entering the environment. In response, the 58th Drugs Consultative Committee (DCC) meeting held on 14th July 2020 decided that specific, clear guidelines were necessary. A DCC sub-committee was assigned to prepare a comprehensive framework, which has now resulted in the present guidance document. This initiative reflects a proactive approach by the authorities to address the pressing issues of environmental contamination and public health threats due to pharmaceutical waste.
Importance of Proper Disposal
Improper disposal of expired and unused medicines can lead to contamination of water bodies, soil, and even the food chain, posing risks to both human and animal health. For example, antibiotics that reach the environment can contribute to antimicrobial resistance (AMR), making infections harder to treat. Expired medicines, if not disposed of properly, can also be misused if they end up in the wrong hands, leading to safety concerns. Moreover, certain expired drugs may develop harmful properties over time, posing risks if consumed accidentally. Therefore, the CDSCO guidance aims to prevent these hazards by promoting responsible disposal practices.
Objective of the Guidance Document for Safe Disposal of Expired and Unused Medicines
The main objective of the CDSCO guidance document is to provide clear, complete, and actionable instructions for the safe disposal of expired and unused medicines. It aligns with the Drugs and Cosmetics Act and Rules, ensuring that stakeholders act in compliance with the legal framework. By following the outlined procedures, stakeholders can help protect the environment, reduce public health risks, and tackle the growing concern of AMR. The document also seeks to educate and involve the public, manufacturers, healthcare institutions, and government agencies in this important mission.
Disposal Methods and Rules By CDSCO
The CDSCO guidance document describes several approved methods for the disposal of expired and unused medicines. One such method is landfilling, where waste is securely encapsulated and disposed of in engineered landfill sites. This prevents medicines from leaching into the environment. Another method is waste immobilization through encapsulation and inertization, where drugs are mixed with substances like cement or lime to prevent their release into the environment.
For liquid pharmaceuticals, the document permits disposal through sewer systems under controlled conditions, ensuring that harmful substances do not enter water bodies. Medium and high-temperature incineration is recommended for certain types of pharmaceutical waste, especially when burning in open containers is discouraged due to air pollution risks. Additionally, chemical decomposition is suggested as an alternative when incineration facilities are not available.
Alignment with Existing Regulations
The guidance document aligns with the Bio-Medical Waste (Management and Handling) Rules, 2016, ensuring that stakeholders are aware of their legal responsibilities. This alignment provides a unified framework for the disposal of pharmaceutical waste, reinforcing accountability across the supply chain. Whether dealing with imported drugs, expired products at retail or wholesale levels, or waste generated at manufacturing sites, the document ensures that all disposal activities comply with established rules and regulations.
Stakeholder’s Responsibilities
Each stakeholder involved in the pharmaceutical supply chain has specific responsibilities under the CDSCO guidance. Manufacturers, wholesalers, and retailers must return expired and unused drugs to the manufacturer or dispose of them as per the outlined procedures. Hospitals and healthcare institutions need to follow safe disposal methods for hospital returns, unused stocks, and samples collected by drug inspectors. Government agencies are also responsible for the proper disposal of medicines from government stockpiles. Detailed records must be maintained at each stage and be made available for regulatory inspections to ensure transparency and accountability.
Collection, Storage, and Transportation Procedures
The CDSCO guidance provides clear instructions for the collection, storage, and transportation of expired and unused medicines. These drugs should be collected in yellow non-chlorinated plastic bags or containers, which are specially designed for medical waste. They must be stored in a designated, secure area to prevent unauthorized access or accidental exposure. During transportation, specific procedures must be followed depending on the type of drug. For example, cytotoxic, radioactive, and controlled substances require additional precautions to ensure safe handling and compliance with legal requirements. These detailed procedures help reduce the risk of accidents and environmental contamination during the disposal process.
Public-Level Initiatives
The CDSCO guidance encourages states to establish drug take-back programs and collection sites for expired medicines. This allows the general public to dispose of unused or expired drugs safely, reducing the risk of accidental ingestion or misuse. Chemist associations may partner with State Drug Authorities and certified waste management agencies to ensure that these programs run efficiently. Public education is also emphasized in the guidance, as raising awareness about the importance of safe disposal is crucial to achieving widespread compliance and success.
Safe Disposal of Specific Medicines
To prevent accidental exposure at home, the CDSCO document includes a list of 17 specific medicines that are approved for safe flushing down sinks or toilets. These medicines are selected because their presence in the home poses a higher risk, especially to children and pets. By providing this list, the guidance helps the public manage certain types of medicine waste responsibly. However, it is important to follow these instructions carefully, as not all medicines are suitable for flushing and improper flushing can lead to environmental harm.
Role of Government and Healthcare Institutions
Government bodies and healthcare institutions play a critical role in implementing the CDSCO guidance. Hospitals must ensure that expired or unused drugs are collected and disposed of according to the outlined procedures. Similarly, government agencies responsible for public health stockpiles must follow strict timelines and documentation practices when disposing of medicines. Compliance with the Drugs and Cosmetics Act and related regulations is essential, and institutions must maintain proper records to demonstrate adherence. By doing so, they contribute to a safer and more responsible pharmaceutical ecosystem.
Preventing Antimicrobial Resistance (AMR)
One of the key drivers behind the CDSCO guidance is the urgent need to combat antimicrobial resistance (AMR). Improper disposal of antibiotics and other antimicrobials in the environment can accelerate the development of resistant microorganisms, making it more difficult to treat common infections. By ensuring that expired and unused antimicrobials are safely disposed of, stakeholders can play a part in slowing down the rise of AMR. This is a shared responsibility that requires collaboration across the pharmaceutical industry, healthcare providers, regulators, and the public.
Benefits of the CDSCO Guidance for for Safe Disposal of Expired and Unused Medicines
The release of the CDSCO guidance offers various benefits.
Helps stakeholders comply with legal requirements
This guidance ensures that pharmaceutical companies, hospitals, retailers, and other stakeholders handle expired and unused medicines as per the regulatory framework. By doing so, they fulfill their legal obligations under health and environmental laws. It promotes accountability in the supply chain and helps avoid legal complications. Compliance also builds public trust in the healthcare system.
Protects public health by reducing risks
Improper disposal of expired medicines can lead to accidental ingestion by children or pets, or even misuse by individuals seeking drugs without prescriptions. The guidance helps prevent these risks by setting proper disposal standards. It ensures expired drugs do not circulate back into the supply chain or get consumed. This contributes to safer households and communities.
Protects the environment from pharmaceutical pollution
Expired and unused medicines, if flushed or thrown into regular trash, can seep into soil and water bodies. These contaminants can harm aquatic life, disrupt ecosystems, and enter the human food chain. The CDSCO guidance encourages environmentally safe disposal methods. This reduces the environmental impact of pharmaceutical waste.
Supports the fight against Antimicrobial Resistance (AMR)
Careless disposal and misuse of antibiotics contribute to AMR—a growing global health threat. The guidance promotes responsible handling of such medicines, minimizing their unnecessary exposure to the environment. It aligns with India's national and global commitments to combat AMR. Responsible pharmaceutical disposal is a key step toward sustainable health practices.
Conclusion
The CDSCO releases guidance for safe disposal of expired and unused medicines, marking a major step toward protecting public health and the environment. By providing detailed procedures, clear responsibilities, and aligning with existing regulations, the guidance offers a comprehensive framework for managing pharmaceutical waste. It emphasizes the importance of stakeholder compliance, public education, and inter-agency collaboration in tackling the challenges posed by medicine waste. Moving forward, it is important that all parties involved understand and implement these guidelines diligently. Together, we can reduce environmental contamination, safeguard human and animal health, and contribute to the global fight against antimicrobial resistance.
 If you need any assistance in CDSCO Registration or have any queries, you can connect with Compliance Calendar Experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. Why has CDSCO released this guidance on expired and unused medicines?
Ans. The CDSCO released this guidance to protect public health and the environment. Improper disposal of medicines can lead to water and soil contamination, accidental ingestion, misuse, and contribute to antimicrobial resistance (AMR). By providing clear instructions, CDSCO aims to help all stakeholders dispose of medicines safely and responsibly.
Q2. Who needs to follow the CDSCO guidance on medicine disposal?
Ans. The guidance applies to manufacturers, wholesalers, retailers, hospitals, healthcare institutions, government agencies, and the general public. Each group has specific responsibilities to ensure expired and unused medicines are collected, stored, transported, and disposed of following legal and environmental safety standards.
Q3. What are the approved methods for disposing of pharmaceutical waste?
Ans. Approved methods include landfilling after encapsulation, chemical decomposition, sewer disposal for certain liquid drugs, and medium to high-temperature incineration. Open burning is discouraged due to air pollution risks. These methods ensure medicines do not contaminate the environment or pose health hazards.
Q4. How can the public safely dispose of expired medicines at home?
Ans. The public is encouraged to use drug take-back programs or collection sites set up by local authorities. For certain high-risk medicines, the CDSCO document provides a list of 17 medicines that can be safely flushed down the sink or toilet to prevent accidental exposure, but all other medicines should be disposed of through proper channels.
Q5. What role do hospitals and healthcare institutions play in medicine disposal?
Ans. Hospitals must collect and store expired or unused medicines in designated containers and follow approved disposal methods. They are also responsible for maintaining accurate records and ensuring compliance with the Drugs and Cosmetics Act. This helps prevent environmental contamination and public health risks.
Q6. How does safe disposal help prevent antimicrobial resistance (AMR)?
Ans. When antibiotics and antimicrobials are improperly discarded into the environment, they can contribute to the development of resistant microorganisms. Safe disposal ensures these substances do not enter the environment, helping to slow the spread of AMR and protect the effectiveness of vital medicines.
Q7. What legal frameworks and rules support this guidance?
Ans. The CDSCO guidance aligns with the Drugs and Cosmetics Act and the Bio-Medical Waste (Management and Handling) Rules, 2016. By following these rules, stakeholders ensure they meet legal obligations, avoid penalties, and contribute to the safe and responsible disposal of pharmaceutical waste.

The Central Drugs Standard Control Organisation (CDSCO) has taken a significant step to safeguard public health and the environment by releasing a detailed guidance document on the safe disposal of expired and unused medicines. This document, issued on 26th May 2025 by the Director General of Health Services, offers comprehensive procedures and methods for various stakeholders to follow, ensuring compliance with laws and minimizing environmental harm. Let us explore the background, objectives, and key components of this guidance in detail.

Background of the CDSCO Initiative

The guidance document from CDSCO stems from a growing concern about the improper disposal of pharmaceutical waste. Researchers brought to CDSCO's attention the serious ecological risks posed by expired and unused medicines entering the environment. In response, the 58th Drugs Consultative Committee (DCC) meeting held on 14th July 2020 decided that specific, clear guidelines were necessary. A DCC sub-committee was assigned to prepare a comprehensive framework, which has now resulted in the present guidance document. This initiative reflects a proactive approach by the authorities to address the pressing issues of environmental contamination and public health threats due to pharmaceutical waste.

Importance of Proper Disposal

Improper disposal of expired and unused medicines can lead to contamination of water bodies, soil, and even the food chain, posing risks to both human and animal health. For example, antibiotics that reach the environment can contribute to antimicrobial resistance (AMR), making infections harder to treat. Expired medicines, if not disposed of properly, can also be misused if they end up in the wrong hands, leading to safety concerns. Moreover, certain expired drugs may develop harmful properties over time, posing risks if consumed accidentally. Therefore, the CDSCO guidance aims to prevent these hazards by promoting responsible disposal practices.

Objective of the Guidance Document for Safe Disposal of Expired and Unused Medicines

The main objective of the CDSCO guidance document is to provide clear, complete, and actionable instructions for the safe disposal of expired and unused medicines. It aligns with the Drugs and Cosmetics Act and Rules, ensuring that stakeholders act in compliance with the legal framework. By following the outlined procedures, stakeholders can help protect the environment, reduce public health risks, and tackle the growing concern of AMR. The document also seeks to educate and involve the public, manufacturers, healthcare institutions, and government agencies in this important mission.

Disposal Methods and Rules By CDSCO

The CDSCO guidance document describes several approved methods for the disposal of expired and unused medicines. One such method is landfilling, where waste is securely encapsulated and disposed of in engineered landfill sites. This prevents medicines from leaching into the environment. Another method is waste immobilization through encapsulation and inertization, where drugs are mixed with substances like cement or lime to prevent their release into the environment.

For liquid pharmaceuticals, the document permits disposal through sewer systems under controlled conditions, ensuring that harmful substances do not enter water bodies. Medium and high-temperature incineration is recommended for certain types of pharmaceutical waste, especially when burning in open containers is discouraged due to air pollution risks. Additionally, chemical decomposition is suggested as an alternative when incineration facilities are not available.

Alignment with Existing Regulations

The guidance document aligns with the Bio-Medical Waste (Management and Handling) Rules, 2016, ensuring that stakeholders are aware of their legal responsibilities. This alignment provides a unified framework for the disposal of pharmaceutical waste, reinforcing accountability across the supply chain. Whether dealing with imported drugs, expired products at retail or wholesale levels, or waste generated at manufacturing sites, the document ensures that all disposal activities comply with established rules and regulations.

Stakeholder’s Responsibilities

Each stakeholder involved in the pharmaceutical supply chain has specific responsibilities under the CDSCO guidance. Manufacturers, wholesalers, and retailers must return expired and unused drugs to the manufacturer or dispose of them as per the outlined procedures. Hospitals and healthcare institutions need to follow safe disposal methods for hospital returns, unused stocks, and samples collected by drug inspectors. Government agencies are also responsible for the proper disposal of medicines from government stockpiles. Detailed records must be maintained at each stage and be made available for regulatory inspections to ensure transparency and accountability.

Collection, Storage, and Transportation Procedures

The CDSCO guidance provides clear instructions for the collection, storage, and transportation of expired and unused medicines. These drugs should be collected in yellow non-chlorinated plastic bags or containers, which are specially designed for medical waste. They must be stored in a designated, secure area to prevent unauthorized access or accidental exposure. During transportation, specific procedures must be followed depending on the type of drug. For example, cytotoxic, radioactive, and controlled substances require additional precautions to ensure safe handling and compliance with legal requirements. These detailed procedures help reduce the risk of accidents and environmental contamination during the disposal process.

Public-Level Initiatives

The CDSCO guidance encourages states to establish drug take-back programs and collection sites for expired medicines. This allows the general public to dispose of unused or expired drugs safely, reducing the risk of accidental ingestion or misuse. Chemist associations may partner with State Drug Authorities and certified waste management agencies to ensure that these programs run efficiently. Public education is also emphasized in the guidance, as raising awareness about the importance of safe disposal is crucial to achieving widespread compliance and success.

Safe Disposal of Specific Medicines

To prevent accidental exposure at home, the CDSCO document includes a list of 17 specific medicines that are approved for safe flushing down sinks or toilets. These medicines are selected because their presence in the home poses a higher risk, especially to children and pets. By providing this list, the guidance helps the public manage certain types of medicine waste responsibly. However, it is important to follow these instructions carefully, as not all medicines are suitable for flushing and improper flushing can lead to environmental harm.

Role of Government and Healthcare Institutions

Government bodies and healthcare institutions play a critical role in implementing the CDSCO guidance. Hospitals must ensure that expired or unused drugs are collected and disposed of according to the outlined procedures. Similarly, government agencies responsible for public health stockpiles must follow strict timelines and documentation practices when disposing of medicines. Compliance with the Drugs and Cosmetics Act and related regulations is essential, and institutions must maintain proper records to demonstrate adherence. By doing so, they contribute to a safer and more responsible pharmaceutical ecosystem.

Preventing Antimicrobial Resistance (AMR)

One of the key drivers behind the CDSCO guidance is the urgent need to combat antimicrobial resistance (AMR). Improper disposal of antibiotics and other antimicrobials in the environment can accelerate the development of resistant microorganisms, making it more difficult to treat common infections. By ensuring that expired and unused antimicrobials are safely disposed of, stakeholders can play a part in slowing down the rise of AMR. This is a shared responsibility that requires collaboration across the pharmaceutical industry, healthcare providers, regulators, and the public.

Benefits of the CDSCO Guidance for for Safe Disposal of Expired and Unused Medicines

The release of the CDSCO guidance offers various benefits.

Helps stakeholders comply with legal requirements

This guidance ensures that pharmaceutical companies, hospitals, retailers, and other stakeholders handle expired and unused medicines as per the regulatory framework. By doing so, they fulfill their legal obligations under health and environmental laws. It promotes accountability in the supply chain and helps avoid legal complications. Compliance also builds public trust in the healthcare system.

Protects public health by reducing risks

Improper disposal of expired medicines can lead to accidental ingestion by children or pets, or even misuse by individuals seeking drugs without prescriptions. The guidance helps prevent these risks by setting proper disposal standards. It ensures expired drugs do not circulate back into the supply chain or get consumed. This contributes to safer households and communities.

Protects the environment from pharmaceutical pollution

Expired and unused medicines, if flushed or thrown into regular trash, can seep into soil and water bodies. These contaminants can harm aquatic life, disrupt ecosystems, and enter the human food chain. The CDSCO guidance encourages environmentally safe disposal methods. This reduces the environmental impact of pharmaceutical waste.

Supports the fight against Antimicrobial Resistance (AMR)

Careless disposal and misuse of antibiotics contribute to AMR—a growing global health threat. The guidance promotes responsible handling of such medicines, minimizing their unnecessary exposure to the environment. It aligns with India's national and global commitments to combat AMR. Responsible pharmaceutical disposal is a key step toward sustainable health practices.

Conclusion

The CDSCO releases guidance for safe disposal of expired and unused medicines, marking a major step toward protecting public health and the environment. By providing detailed procedures, clear responsibilities, and aligning with existing regulations, the guidance offers a comprehensive framework for managing pharmaceutical waste. It emphasizes the importance of stakeholder compliance, public education, and inter-agency collaboration in tackling the challenges posed by medicine waste. Moving forward, it is important that all parties involved understand and implement these guidelines diligently. Together, we can reduce environmental contamination, safeguard human and animal health, and contribute to the global fight against antimicrobial resistance.

If you need any assistance in CDSCO Registration or have any queries, you can connect with Compliance Calendar Experts through email at info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. Why has CDSCO released this guidance on expired and unused medicines?

Ans. The CDSCO released this guidance to protect public health and the environment. Improper disposal of medicines can lead to water and soil contamination, accidental ingestion, misuse, and contribute to antimicrobial resistance (AMR). By providing clear instructions, CDSCO aims to help all stakeholders dispose of medicines safely and responsibly.

Q2. Who needs to follow the CDSCO guidance on medicine disposal?

Ans. The guidance applies to manufacturers, wholesalers, retailers, hospitals, healthcare institutions, government agencies, and the general public. Each group has specific responsibilities to ensure expired and unused medicines are collected, stored, transported, and disposed of following legal and environmental safety standards.

Q3. What are the approved methods for disposing of pharmaceutical waste?

Ans. Approved methods include landfilling after encapsulation, chemical decomposition, sewer disposal for certain liquid drugs, and medium to high-temperature incineration. Open burning is discouraged due to air pollution risks. These methods ensure medicines do not contaminate the environment or pose health hazards.

Q4. How can the public safely dispose of expired medicines at home?

Ans. The public is encouraged to use drug take-back programs or collection sites set up by local authorities. For certain high-risk medicines, the CDSCO document provides a list of 17 medicines that can be safely flushed down the sink or toilet to prevent accidental exposure, but all other medicines should be disposed of through proper channels.

Q5. What role do hospitals and healthcare institutions play in medicine disposal?

Ans. Hospitals must collect and store expired or unused medicines in designated containers and follow approved disposal methods. They are also responsible for maintaining accurate records and ensuring compliance with the Drugs and Cosmetics Act. This helps prevent environmental contamination and public health risks.

Q6. How does safe disposal help prevent antimicrobial resistance (AMR)?

Ans. When antibiotics and antimicrobials are improperly discarded into the environment, they can contribute to the development of resistant microorganisms. Safe disposal ensures these substances do not enter the environment, helping to slow the spread of AMR and protect the effectiveness of vital medicines.

Q7. What legal frameworks and rules support this guidance?

Ans. The CDSCO guidance aligns with the Drugs and Cosmetics Act and the Bio-Medical Waste (Management and Handling) Rules, 2016. By following these rules, stakeholders ensure they meet legal obligations, avoid penalties, and contribute to the safe and responsible disposal of pharmaceutical waste.