Prescription for Cleanup: CDSCO’s Guidelines to Ditch Old Drugs

Updated: May 05, 2025 11:07

Image Source: Medicare News

India's top drug regulator, the Central Drugs Standard Control Organization (CDSCO), is gearing up to release detailed guidelines for the disposal of unused and expired medicines. The step will help avoid misuse, stem antimicrobial resistance (AMR), and safeguard public health and the environment.

Unlawful disposal of medicines-like dumping them into household waste or water bodies-is threatening in many ways, ranging from causing environmental contamination to presenting risks to public health and spreading antimicrobial resistance. To counter this, the CDSCO is in the process of formulating guidelines for the safe collection, storage, and disposal of such drugs throughout India.

Background and Need

The CDSCO is formulating guidelines to tackle the unsafe disposal of unused and expired medicines, which may result in drug abuse, pollution of the environment, and also contribute to antimicrobial resistance.
Research has emphasized the risks posed by pharmaceutical substances entering the environment, particularly water bodies, through unscientific means of disposal.

Scope and Features of the New Guidelines

The guidance document will specify procedures for the safe disposal, collection, storage, and transportation of unused and expired drugs.

It will contain best practices from international standards, including those of the World Health Organization (WHO) and the US Food and Drug Administration (USFDA), and will be in conformity with the Biomedical Waste (Management and Handling) Rules, 2016.
Special guidelines will be laid down for disposing of drugs hazardous in nature, such as antineoplastic (cancer) drugs.

Implementation and Regulatory Developments

The policy document is complete and will shortly be made available for adoption countrywide.

Latest modifications to Schedule M under the Drug Rules have already established mandates for manufacturers with regard to proper storage of waste material pending disposal.
The National Council for Clinical Establishments (NCCE) also suggested preparing minimum standards for the disposal of expired or unused drugs at clinical establishments with the aim of providing dedicated public-accessible spaces for drug disposal.

Public Health and Environmental Impact

The action will help minimize the risk of medicines being diverted for misuse or getting into the environment, thus curbing the spread of antimicrobial resistance and protecting public and animal health.
Appropriate disposal methods will prevent soil and water body pollution due to pharmaceuticals, a threat identified by ongoing research and pilot studies in states such as Kerala.

Pilot Projects and State Actions

Kerala initiated a pathbreaking project, 'nPROUD', for collecting expired and unused medicines from homes and scientifically disposing of them, paving the way for other states.

Conclusion

CDSCO's upcoming guidelines are a big step towards sustainable pharmaceutical waste management in India. Through the provision of well-defined guidelines and taking inspiration from international best practices, these initiatives will aim to safeguard health, avert diversion, and ensure environmental sustainability.

Relevant Sources: DrugsControl, ET HealthWorld, Pharmabiz, Economic Times

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