The pharmaceutical industry generates a lot of waste during drug manufacturing and testing. It is important to ensure that this waste is appropriately treated to prevent it from polluting the environment.
According to the provisions of cGMP under Schedule M of the
Drugs & Cosmetics Act,
1. Sewage and effluents from a pharmaceutical manufacturing
unit must conform to the regulations of the Environment Pollution Control
Board.
2. All bio-medical waste destruction should proceed in
keeping with the provisions of the Bio-Medical Waste (Management and Handling)
Rules, 1996.
3. Rejected drugs must be stored and disposed of with extra
care to prevent them from getting mixed up with stock meant for distribution.
4. Waste disposal records shall be maintained.
5. Materials awaiting disposal must be stored in a safe way
to avoid their misuse and also to prevent any cross-contamination or mixups.
Types of Waste
Waste in the pharmaceutical industry may be of different
types, and it generally falls into the following categories:
1. Hazardous wastes
2. Non-hazardous wastes
3. Inert substances
4. Biomedical wastes
(a) Hazardous wastes: As the name indicates, these
are wastes that are potentially dangerous to human health or the environment.
They may be solid, liquids, gas-containing, or sludgy in nature. Such waste
contains chemical products that may be ignitable (example-inflammable organic
solvents), corrosive (example-strong acids and alkalis), reactive
(example-fumes, gases), and toxic (example-heavy metals).
(b) Non-hazardous wastes: These are materials that do
not present a significant hazard at the levels in which they are present.
(c) Inert substances: These are materials that do not
have any therapeutic effect, but they are used for supportive nutrition, for
example, dextrose or sodium chloride solutions. They may however become mixed
with other chemicals and therefore, have to be checked for hazardous properties
before further disposal.
(d) Biomedical wastes: These are wastes generated
during the treatment or diagnosis of human beings or animals or during
biological material production and testing. Hospital waste is a major example
of this type.