1. Pharmaceutical Waste Management
PARAS SHAH

2. 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

3. Biomedical Waste (Management and Handling) Rules
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

4. Prescribed Authorities
State : Gujarat Pollution Control Board
Central : Ministry of Environment and Forest , Central Pollution Control Board

5. Records
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

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

7. Methods of Disposal Return to Donor or mfg.
- Near expire goods
- Cross-frontier transport

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

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

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

11. Immobilization-Encapsulation
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

12. Inertization: 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

13. Sewer: 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

14. Burning in Open containers
Not for Pharmaceuticals
Paper and cardboard packaging
PVC not burnt

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

16. High Temp. Incineration
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

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

18. Schedule I Category Type of Material Method Category No. 1
Human Anatomical Waste
(human tissues, organs, body parts)
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)
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 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

19. Category No. 4
Waste sharps
(needles, syringes, scalpels, blades, glass, etc. that may cause
puncture 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
contaminated with blood)
Incineration, autoclaving, microwaving
Category No. 7
(wastes generated from disposable items other than the waste sharps
such as tubings, catheters, intravenous sets etc).
Disinfection by chemical treatment , autoclaving, microwaving, mutilation and shredding

20. Category No. 8
Liquid Waste
(waste generated from laboratory and washing, cleaning, house- disinfection by chemical
keeping 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.