India India revises effluent and emission standards for bulk drug and formulation industry

additional effluent parameters and new emission standards

On August 6, 2021, the Ministry of Environment, Forests and Climate Change of India published the Environment (Protection) Second Amendment Rules, 2021 in the Official Gazette. The rules amended the effluent standards and emission standards for the bulk drug and formulation (pharmaceutical) industry, specified in No. 73 of the Schedule I (Emission or Discharge Standards by Industry) of the Environment (Protection) Rules, 1986. Specifically, parameters such as ammoniacal nitrogen, COD, benzene, xylene, methylene chloride and chlorobenzene are added to effluent standards and emission standards are newly established. The amendment comes into effect after 1 year from the date of the publication in the Official Gazette.

The Environment (Protection) Second Amendment Rules, 2021 can be downloaded from the following URL.

S.No. Industry Parameters Standard
1 2 3 4
“73 Bulk Drug and Formulation (Pharmaceutical) A.   Effluent Standards*
Limiting value for concentration (mg/l, except for PH and Bio assay)
(i)         Compulsory Parameters
pH 6.0-8.5
BOD (3 days、27℃) 30
COD 250
TSS 100
Oil & Grease 10
Ammoniacal Nitrogen 100
Bio – Assay Test** 90% Survival of Fish after first 96 hours in 100% effluent
(ii)        Additional Parameters##
***Benzene 0.1
***Xylene 0.12
***Methylene Chloride 0.9
***Chlorobenzene 0.2
Phosphates as P 5
Sulphides as S 2
Phenolic Compounds 1
Zinc 5
Copper 3
Total Chromium 2
Hexavalent Chromium (Cr6+) 0.1
Cyanide (as HCN) 0.1
Arsenic 0.2
Mercury 0.01
Lead 0.1
Sodium Adsorption Ratio (SAR) Less than 26 (applicable only for discharge on land)
(iii)       Industry connected with CETP
l  The discharge norms for CETP and industries connected with CETP are complied with the notification S.O.4 (E) of Ministry of Environment, Forests and Climate Change dated January 1, 2016.

l  State Pollution Control Board (SPCB) prescribes additional relevant parameters as indicated in parameter A (ii) of this notification depending on needs and discharge potential of each industry and specify the frequency of monitoring considering conditions of the receiving environment.

B.   Emission Standards (Tank farm Vents)
Parameters Limiting value for concentration (mg/Nm3 )
Chlorine 15
Hydrochloric acid vapor 35
Ammonia 30
Benzene 5
Toluene 100
Acetonitrile 1000
Dichloromethane 200
Xylene 100
Acetone 2000

*Not applicable to industry discharging to CETP but applicable to all discharge to land and surface water bodies including use of treated wastewater for horticultural or irrigation purpose.
**The Bio assay test must be carried out as per IS: 6582-1971.
##Parameters listed as additional parameters are specified by SPCB depending on the process and product and its monitoring frequency must be monthly or quarterly as decided by SPCBs.
***Limits are applicable to industries that use benzene, xylene, methylene chloride and chlorobenzene.

†The total cumulative losses of solvents must not exceed 5% of the storage inventory on an annual basis.
‡Chemical and biological sludge or any residue, reject, concentrate generated from wastewater treatment or its management facility at Industry or CETP catering to industries engaged in manufacturing of bulk drug or formulation of Pharmaceuticals,  are classified as hazardous waste in accordance with the provision of clause 17 of sub-rule (i) of rule 3 of the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 and are subject to the provision made therein.