The Central Pollution Control Board (CPCB) has invited comments on ‘Draft guidelines for the Pharmaceutical Industry in India’ till 5th February 2025.

Comments if any may be submitted on the following e-mail address: dinabandhu.cpcb@nic.in (Sh. Dinabandhu Gouda, Scientist ‘F’, IPC-I Division) and rnpankaj.cpcb@nic.in (Sh. Raj Narayan Pankaj, Scientist ‘E’, IPC-I Division, CPCB). Alternatively comments may be sent by post to ‘Director & Divisional Head IPC-I Division Central Pollution Control Board Parivesh Bhawan East Arjun Nager Delhi – 32.

Key Highlights:

Classification of the Pharmaceutical Industry 

The pharmaceutical industry is primarily divided into four sectors: Pharmaceutical Formulation, Vaccine Manufacturing, Ayurvedic or Unani Medicine, and Pharma R&D. According to the 2016 revised industrial classification, the CPCB categorizes the pharmaceutical sector as one of 17 Highly Polluting Industries. Within this classification, the industry is further divided into ‘Red’ and ‘Orange’ categories based on pollution levels—’Pharmaceuticals’ are classified under ‘Red’ due to high pollution, while ‘Pharmaceutical Formulation & R&D’ are categorized as ‘Orange’ due to relatively lower pollution. The pharmaceutical sector is also sub-categorized into Pharmaceutical Manufacturing, R&D, Formulation, and Vaccine Manufacturing. Additionally, industries using cleaner or gaseous fuels are given a separate classification for each category.

Siting criteria for the pharmaceutical industry 

The Central Government has determined that siting restrictions for industries should be updated to reflect advancements in industrial planning and technology, with a focus on protecting sensitive areas such as national parks, sanctuaries, wetlands, and archaeological sites. Pharmaceutical industries producing Active Pharmaceutical Ingredients (APIs) and intermediates must adhere to relevant siting criteria set by Central/State/Union Territory authorities, and comply with orders from the National Green Tribunal and other court directives. Specific distance requirements include:

1. From the nearest boundary of surface water body (flood plain/ HFL / Red line) as per the revenue sketch:
   1. Red Category: Minimum 500 meters
   2. Orange Category
      • With effluent generation: Minimum 75 meters
      • Without effluent generation: Minimum 30 meters
2. From the settlement, educational institute, worship place, archaeological monuments, national park, reserve forest, heritage site, shall be maintained:
   1. Red Category: Minimum 500 meters
   2. Orange Category: Minimum 200 meters
3. Applicability of other prevalent laws, rules, and regulations, and notifications shall be verified and complied with.
4. The natural / storm drain passing through premises shall not be disturbed.
5. The industry shall develop a greenbelt using native species along the boundary by planting tall growing, evergreen trees. The total green area, including landscaping, will cover 33% of the plant area. The width of the said green belt will vary from 15m to 100m along the boundary based on production process, production capacity, pollution control measures, nearby/adjacent recipients, etc., as decided by SPCB/PCC. Such green belt to have plant density of 1500 to 2500 plants per hectare
6. SPCBs/PCCs may prescribe additional siting criteria/measures on case-to case basis

Management of Waste water

Waste streams should be segregated into high COD waste, toxic waste, low COD waste, inorganic waste etc.

1. High COD streams shall be detoxified and treated in Effluent Treatment Plant (ETP) or thermally destroyed in incinerator.
2. The industry should carry out the analysis of various prescribed effluent/soil/ground water quality parameters from the NABL/EPA recognised/accredited laboratories.
3. The industry should construct impervious lined storage tank of minimum 15 days capacity for storage of treated effluent during low/no demand, based on the Irrigation Management Plan (IMP).
4. The Unit shall provide sludge de watering equipment/system in ETP and shall provide proper flooring in ETP area. The Unit should provide adequate numbers of flow meters at inlet and out let of ETP and different sources of wastewater streams.
5. The ETP shall consist of units for physical and chemical processes and tertiary treatment system like activated carbon filter.
6. The ETP shall conform to the notified effluent standards of MoEF&CC for Bulk Drug and Formulation (Pharmaceutical).
7. The Industry should carry out adequacy assessment of effluent treatment plant (ETP) from reputed government institute and accordingly upgrade ETP so as to achieve prescribed standards.
8. The Unit shall provide separate stripper followed by MEE for high COD/TDS wastewater treatment.

Management of Air Emission

Industry should take up on priority, the control of hazardous air pollutants (such as benzene, carbon tetrachloride, 1-4 dioxin, methanol, toluene, methyl chloride etc.) and odorous compounds (mercapatan & hydrogen sulphide).

1. The industry shall recover up to 95 % of spent solvent in captive units installed in their industry and may send to common solvent recovery units, depending on the quantity handled.
2. The total cumulative losses of solvent should not be more than 5% of the solvent on annual basis from storage inventory is notified for pharmaceutical sector.
3. The industry shall provide adequate treatment facilities with air pollution control devices such as scrubbers, condensers, absorbers to reduce volatile organic compounds (VOCs) and particulate emissions.
4. The unit shall install various types of control technologies for control of VOCs and shall adopt Leak detection and Repair Programme(LDAR) to minimize VOCs emission

Management of Hazardous waste  

High COD streams should be detoxified and treated in ETP or thermally destroyed either in captive incinerator or common hazardous waste incinerator.

1. The industry shall use high-efficiency incineration methods for hazardous waste, ensuring emissions meet regulatory standards.
2. All monitored values shall be corrected to 11% oxygen on dry basis.
3. The CO2 concentration in tail gas shall not be less than 7%.
4. In case, halogenated organic waste is less than 1% by weight in input waste, all the facilities in twin chamber incinerator shall be designed so as to achieve a minimum temperature of 850 ± 25 °C in primary chamber and 950 °C in secondary combustion chamber and with a gas residence time in secondary combustion chamber not less than two seconds.
5. All the facilities in single chamber incinerator for gaseous hazardous waste shall be designed so as to achieve a minimum temperature of 950 °C in the combustion chamber with a gas residence time not less than two seconds.

 Zero Liquid Discharge (ZLD)

CPCB has recommended that ZLD (Zero Liquid Discharge) requirement is possible for the pharmaceutical industry intended only to promote recycling/reuse of wastewater and conservation of water and environment.

1. The industry shall recycle and reuse of waste water as far as practicable in order to minimize the fresh water consumption and discharge of waste water into the environment.
2. The industry should install facilities and system to achieve ZLD status, which will enable industrial effluent for absolute recycling of or re-use and converting solute (dissolved organic and in-organic compounds / salts) into residue in solid form by adopting method of “concentration and evaporation. ZLD should be achieved by adopting conventional primary, secondary and tertiary effluent treatment and polishing by filtration and using clean water back into process / or domestic use.
3. The Industry should re-use RO permeate only for cooling tower/ manufacturing purposes and shall also ensure Zero Liquid Discharge (ZLD) as per the CTO condition.

General Conditions

The industry shall use Compliance Reporting Protocol (CRP) for submission of information on management of emission and effluent discharges. The Integrated Guidance Framework for Chemicals Safety in respect of the Isolated Storage and Industries covered under Manufacture, Storage and Import of Hazardous Chemicals (MSIHC) Rules, 1989 for safety purpose has been prepared as per the Hon’ble NGT directions dated 11.06.2021 and circulated to all SPCBs/ PCCs for implementation.

For further details, a copy of the Draft is linked below for your reference.

Source: Central Pollution Control Board

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