Pharmaceutical Waste Management

Waste & Effluents (E/C PCB). Bio-Medical Waste (Management and Handling) Rules, 1996 Additional precaution for storage and disposal of rejected drugs Records Proper and safe storage of waste materials awaiting disposal

Duty of Occupier to make sure wastes are handled in a way which does not affect human health and environment

Treated and disposed as per Schedule I as per the standards in Schedule V

State : Gujarat Pollution Control Board Central : Ministry of Environment and Forest , Central Pollution Control Board

Annual Report Form II (Annexure III) by 31st January every year. (includes Categories and quantities) Annual Report sent to CPCB by 31st March. Authorized person maintains the records related to generation, collection, reception, storage, transportation, treatment, disposal and/or any form of handling of bio-medical waste

Accident Reporting: Authorized person has to report the accident in Form III (Annexure-IV).

- Near expire goods - Cross-frontier transport

Open Uncontrolled non-engineered dump Not environment friendly Use only as last resort Only after immobilization or inertization Cover with municipal waste Pollutes aquifer

Engineered Landfill Protects loss of chemicals into aquifer Immobilized best Direct deposit second best

Highly Engineered Sanitary Landfill Properly Constructed and Operated Protects aquifer Isolated pit Compacted and covered with soil

Solid block in plastic or steel drum Filled to 75% capacity Solid semisolid pharmaceuticals are added, then cement, lime and water are added Ratio of lime, cement and water 15:15:5 W Welded and filled

Remove all packaging materials Ground and mixed with water, cement and lime. Then disposed with municipal waste Ratio Pharmaceutical, cement, lime and water is 65:15:15:5

Liquid pharmaceuticals diluted with water flushed into sewers. Properly diluted and flushed in large and fast moving quantities of sewer. Hydrogeologist or sanitary engineer may be needed in case of damaged sewer

Not for Pharmaceuticals Paper and cardboard packaging PVC not burnt

Operates around 850 degree Celsius Not for halogen compounds Material diluted with large municipal waste (1:1000) and then incinerated.

Cement kilns, Coal fired thermal stations Higher combustion retention time and expel gas at higher altitude via chimneys. Remove packaging materials Burn with fuel Not more than 5% of fuel at one time. Fast and large quantities can be disposed

Chemical decomposition followed by landfill. Tedious and time-consuming Only for small quantities

Category Type of Material Method

Category No. 1

Human Anatomical Waste(human tissues, organs, body parts)

incineration@/deep burial

Category No. 2

Animal Waste(animal tissues, organs, body parts carcasses, bleeding parts, fluid,blood and experimental animals used in research, waste generated by veterinary hospitals colleges, discharge from hospitals, animal houses)

incineration@/deep burial

Category No. 3

Microbiology & Biotechnology Waste(wastes from laboratory cultures, stocks or specimens of micro-local autoclaving/micro-organisms live or attenuated vaccines, human and animal cellwaving/incineration@culture used in research and infectious agents from research and industrial laboratories, wastes from production of biologicals, toxins, dishes and devices used for transfer of cultures)

Local autoclaving, microwaving or incineration

Category No. 4 Waste sharps(needles, syringes, scalpels, blades, glass, etc. that may causepuncture and cuts. This includes both used and unused sharps)

Disinfection, autoclaving, microwaving, mutilation and shredding

Category No. 5 Discarded Medicines and Cytotoxic drugs(wastes comprising of outdated, contaminated and discarded medicines)

Incineration and landfill

Category No. 6 Solid Waste(Items contaminated with blood, and body fluids including cotton,dressings, soiled plaster casts, lines, beddings, other material incineration@contaminated with blood)

Incineration, autoclaving, microwaving

Category No. 7 Solid Waste(wastes generated from disposable items other than the waste sharpssuch as tubings, catheters, intravenous sets etc).

Disinfection by chemical treatment , autoclaving, microwaving, mutilation and shredding

Category No. 8

Liquid Waste(waste generated from laboratory and washing, cleaning, house-disinfection by chemicalkeeping and disinfecting activities)

Disinfection by chemical treatment and then discarded in drains

Category No. 9

Incineration Ash(ash from incineration of any bio-medical waste)

Disposal in municipal landfills

Category No. 10

Chemical Waste(chemicals used in production of biologicals, chemicals used in disinfection, as insecticides, etc.)

Chemical treatment. Then solids in landfills and liquids in drains.