The CDSCO is likely to issue comprehensive guidelines for the safe disposal of unused and expired drugs by the general public and hospitals in the near future. The guidance document, drafted by a sub-committee of DCC, has also been vetted by the DTAB, which has suggested its distribution among regulatory and healthcare networks.

Key Highlights

Guidelines Finalized By Expert Committee

• The advice was drafted by a sub-committee of the Drugs Consultative Committee (DCC) in October 2020.

• The final report was examined at the 64th DCC meeting held in June 2024 and placed before the 92nd DTAB meeting.

Future Steps For Implementation

• DTAB has suggested uploading the advice on the website of CDSCO and informing State/UT Drug Controllers accordingly.

• It also suggested circulation to all medical colleges through the Directorate General of Health Services (DGHS).

Environmental Concerns Behind Initiative

• The initiative followed a letter from AIIMS Delhi citing a study on pharmaceutical waste in Delhi’s water sources.

• The study found antimicrobial agents and other Active Pharmaceutical Compounds (APCs) in surface and groundwater at levels exceeding 0.1 µg/L.

International Benchmarks Considered

• The document references global guidelines including those of the WHO and USFDA.

• Even though WHO does not at present include pharmaceutical residues in drinking water standards, environmental research has raised concerns regarding levels of contamination.

Revised GMP Norms For Manufacturers
With the revised Schedule M norms implemented in 2024, drug manufacturers are now required to store waste to be disposed of safely.In increasing environmental and public health issues, India's top drug regulator is nearing finalization of a nationwide system for discarding medicines. After their release, these directives will be one major step closer toward safer waste disposal of pharma products through hospitals, residential places, and factories.