### Policy Development for Safe Disposal Practices
The Pharmaceuticals Department (DoP) is actively working on establishing a ‘Safe Disposal Policy’ aimed at effectively removing expired and unused medications from retail outlets and domestic spaces. To facilitate this, a specialized committee has been constituted by the DoP, with the Kerala drug controller being the sole representative from the state regulatory bodies. This inclusion is warranted, given that it was Dr. Revi Menon, then Kerala’s drug controller, who introduced an innovative initiative in 2018 to address the improper disposal of outdated and unused pharmaceuticals. This initiative was rolled out in collaboration with the All Kerala Chemists and Druggists Association.
Together, they initiated the ‘Program on Removal of Unused Drugs’ (PROUD), which continues to operate in Thiruvananthapuram district, Kerala. As part of this initiative, selected drug stores have been equipped with collection boxes for expired or unused medicines, enabling consumers and retailers alike to dispose of these pharmaceuticals safely. The gathered medications are then collected by the department and incinerated by a designated agency.
**Significance of the DoP Initiative**
The effort to develop a ‘Safe Disposal Policy’ is a crucial advancement, considering that improper disposal of expired, surplus, substandard, counterfeit, and adulterated medications is a leading contributor to antimicrobial resistance in both animals and humans. Given the mounting concern over global antimicrobial resistance, this initiative arrives at a critical moment as the World Health Organization has emphasized the urgency for developing protocols for the secure disposal of unused or expired medications, particularly antibiotics.
Research underscores that antibiotic residues and resistance pose alarming environmental and health threats. Therefore, regulatory frameworks are essential to manage pharmaceutical waste arising from manufacturing sites, pharmacies, hospitals, wholesale suppliers, and residential households. There is a pressing requirement for a dedicated legislative approach akin to the Solid, Plastic, Bio-medical, and Hazardous Waste Management Acts to adequately address this concern.
The hazards are evident, as unauthorized disposal practices by retailers and the public can lead to severe human and animal diseases and allergic responses. The prevailing circumstances necessitate an organized pharmaceutical waste management system.
**Current Challenges and Future Actions**
Currently, due to the lack of precise regulations for the timely recall and disposal of expired drugs, the matter remains a significant challenge in need of resolution. As the Drugs & Cosmetics Act does not comprehensively address this, the pharmaceutical industry and trade continue to wrestle with the burgeoning inventory of expired medications accumulating across their operations. With the domestic pharmaceutical sector advancing rapidly, now valued at ₹1.2 lakh crore, the obligation to safely manage drug and pharmaceutical waste extends across the consumer, healthcare, retail, and manufacturing domains.
Estimates suggest that expired drugs constitute 1.5 to 2 percent of the total drug market output, translating into substantial waste quantities. Hence, under these circumstances, the DoP’s initiative in framing a robust Disposal Policy is commendable and necessary.