The Central Drugs Standard Control Organisation (CDSCO) has issued guidelines for disposing of expired and unused medicines.

Impact of improper disposal of drugs

• Expired drug refers to drugs which have crossed the expiry date mentioned on the label.

• Unused drugs refer to the medications that have not been used by the individual for whom they were prescribed or purchased.

• Improper disposal of expired/unused drugs is detrimental to human, animal and environment and may be hazardous if it leads to contamination of water supplies or local sources used by nearby communities or wildlife. 

• Expired drugs may come into the hands of ragpickers and children if a landfill is insecure. Pilfering from a stockpile of waste drugs or during sorting may result in expired drugs being diverted to the market for resale and misuse.

• Most pharmaceuticals past their expiry date become less efficacious and a few may develop a different adverse drug reaction profile. There are some categories of expired drugs or defective disposal practices that carry a public health risk.

• Unscientific disposal of unused or expired drugs is considered as one of the primary reasons for environmental pollution. Used antibiotics, which are often disposed of carelessly, seeps into the soil and water bodies, eventually affecting human life.

• Researchers had highlighted a study aimed to assess the extent of exposure of Active Pharmaceutical Compounds (APCs) in the hydrologic cycle in and around New Delhi. The study stated the role of

ecological exposure due to the disposal of unused and expired pharmaceutical compounds into landfills and indicated that un-segregated drug disposal could be a reason for the emergence of drug resistance with special reference to antibiotics. 

• The issue was discussed in 58th Drugs Consultative Committee (DCC) held on July 14, 2020 and it was decided that there should be clear defined guidelines for disposal of expired/unused drugs.

Central Drugs Standard Control Organisation (CDSCO)

• The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India, is the central authority for regulating the quality of drugs marketed in the country under the Drugs and Cosmetics Act, 1940. 

• Import or manufacture for sale of drugs including vaccines are regulated under Drugs and Cosmetics Act, 1940 and Drugs & cosmetics Rules, 1945 and New Drugs and Clinical Trials Rules, 2019.

• The mission of CDSCO is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

• Regulatory control over the import of drugs, approval of new drugs and clinical trials, approval of certain licenses as Central License Approving Authority are major functions of CDSCO.

• The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics. 

• It envisages uniform implementation of the provisions of the Act and Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. 

• As per the rules, products like vaccines, r-DNA derived products, stem cell derived products, gene therapeutic products, etc are always considered to be new drugs. For such products manufacturers are required to obtain manufacturing permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before licensing the product under the Drugs and Cosmetics Rules, 1945.

• CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

• The CDSCO, with its headquarters in New Delhi, has eight zonal offices, seven sub-zonal offices, 19 port offices, seven central laboratories and six mini labs under its control.

Manorama Yearbook app is now available on Google Play Store and iOS App Store