bulk drugs & formulation units as per Environment Rules, 2021

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Environment (Protection) Amendment Rules, 2021 defines revised emission & effluent discharge norms for bulk drugs & formulation units. As per amended legal provision,

(1) Bio-assay test is also applicable as per IS 6582:1971 to these units.

(2) Those units connected with CETP facility, these norms are not applicable, including usage of treated water for gardening purpose.

(3) Additional parameters are also to be made applicable depends on processes adopted by such industry and it may be defined in consent by respective State Pollution Control Board (SPCB).

Now, therefore, in exercise of the powers conferred by sections 6 and 25 of the Environment
(Protection) Act, 1986 (29 of 1986) read with sub-rule (3) of rule 5 of the Environment (Protection) Rules,
1986, the Central Government hereby makes the following rules further to amend the Environment
(Protection) Rules, 1986,

Date of Release – 06.08.2021

Applicable – Pharma Industry (bulk drugs and formulation units)

Download Environment (Protection) Amendment Rules, 2021

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