The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance outlining safe and systematic disposal methods for expired and unused drugs. The directive aims to improve environmental safety, minimize public health risks, and enforce better compliance across the pharmaceutical sector.

Key highlights

Strict sorting and categorization required

• Manufacturers must separate hazardous categories like controlled substances, cytotoxic drugs, anti-infectives, and radioactive drugs for distinct disposal methods.

• Mixing hazardous drugs with others is prohibited under the new norms.

Color-coded storage and transport rules

• Expired drugs to be collected in yellow non-chlorinated plastic bags/containers.

• Drugs must be stored separately based on category in secured, designated locations.

• Transportation should follow Biomedical Waste Rules, 2016, and Motor Vehicle Act, 1988 guidelines.

Detailed disposal methods outlined

• Solids and powders: Landfill, encapsulation, inertisation, or high-temperature incineration.

• Liquids: Sewer disposal or high-temperature incineration.

• Ampoules: Crush, dilute, and flush—no incineration allowed.

• Aerosol canisters and PVC/glass: Landfill or encapsulation; no burning.

• Antibiotics and anti-infectives: Inertisation and incineration; liquid antibiotics can be diluted and discharged.

• Antineoplastics and controlled drugs: Only high-temperature disposal allowed; landfilling only after encapsulation.

• Radioactive drugs: Deep geological disposal per AERB guidelines.

Disinfectant disposal limits

• Up to 50 liters/day of diluted disinfectants can be released into fast-flowing water, under supervision only.

CDSCO’s new guidance is a major step in enforcing scientific pharmaceutical waste management, especially as India scales up its fight against antimicrobial resistance (AMR). With detailed protocols and segregation norms, manufacturers are now under greater responsibility to ensure safe and legal disposal of expired or unused drugs.