Despite having a significant pollution potential, the pharmaceutical industry in India lacks specific guidelines for pollution management. The National Green Tribunal (Chennai) took cognizance of this issue in its Order dated 27th November 2024 and directed the Central Pollution Control Board (CPCB) to bring out guidelines exclusively for this sector. Pursuant to this direction, the CPCB has recently published the draft ‘Guidelines for the Pharmaceutical Industry in India’ (“Draft Guidelines”) which provides mechanism for management of wastewater, air emission, hazardous waste etc. generated during the pharma manufacturing processes. It also prescribes siting criteria and measures to regulate consumption of resources while introducing Zero Liquid Discharge (ZLD) requirement and general conditions for sampling and monitoring.

The Draft Guidelines categorize pharmaceutical industries into four groups—Formulation, Vaccine Manufacturing, Ayurvedic/Unani Medicine, and Pharma R&D. Based on pollution index, it also designates industries producing Active Pharmaceutical Ingredients (APIs) as highly polluting under the “Red” category, while formulation and R&D units fall under the “Orange” category. As per the minimum requirements, the red category units have been mandated to-

• maintain a minimum 500-meter buffer from surface water bodies and settlements, and
• develop greenbelts using native species along the boundary by planting tall evergreen trees. The total green area (including landscaping) will cover 33% of the plant area having plant density of 1500 to 2500 plants per hectare.

In addition to the minimum requirements enumerated in this Draft, the red category units are also required to comply with respective siting criteria prescribed by the concerned authorities.

It has been further emphasized that all pharmaceutical industries are required to comply with the notified emission and effluent standards, besides any other specific conditions laid down by concerned State Pollution Control Boards / Pollution Control Committees in the Consent to Operate, issued to individual industry under Water (Prevention and Control of Pollution) Act, 1974, Air (Prevention and Control of Pollution) Act, 1981 and authorization under Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016.

The provisions prescribed by the Draft for management of various pollutants include the following:

1. Management of wastewater- Wastewater streams in pharmaceuticals and biotechnology manufacturing are to be segregated into high chemical oxygen demand (COD) waste, toxic waste, low COD waste, inorganic waste etc while high COD streams shall be detoxified and treated in Effluent Treatment Plant (ETP) or thermally destroyed in incinerator. Further, 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).
2. Management of air pollutants- 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) are to be taken up on priority by the industries. Up to 95 % of spent solvent shall be recovered in captive units installed in the industry and may be sent to common solvent recovery units, depending on the quantity handled.
3. Management of hazardous wastes- Proper facilities shall be provided for handling and storage of hazardous waste which includes the chemical and biological sludge or any residue, reject, concentrate generated from wastewater treatment or its management facility. For final disposal of hazardous waste, recycling and reuse should be given priority, either within the premises or outside with proper manifest system. In case of incinerable waste, properly designed incinerator should be installed within the premises or outside as a common facility. The non-incinerable hazardous waste should be disposed of in properly designed secure landfill either within the industry’s premises or in a common facility.
4. High COD streams should be detoxified and treated in ETP or thermally destroyed either in captive incinerator or common hazardous waste incinerator. The industry shall use high-efficiency incineration methods for hazardous waste, ensuring emissions meet regulatory standards.
5. The Pharmaceutical Manufacturing Plant should install Online Continuous Monitoring System (OCEMS) w.r.t parameters; pH, BOD, COD, TSS and Flow meter in case of discharge to Land for irrigation and inland surface water.
6. The industries will have to submit the Environmental Statement to SPCBs/PCC by September 30 of each year in form V.

In conclusion, the draft ‘Guidelines for the Pharmaceutical Industry in India’ represent a much-awaited step toward addressing the environmental challenges posed by the sector. The guidelines also emphasize the adoption of green chemistry principles, promoting sustainability and resource efficiency within the industry. However, while the guidelines provide a regulatory framework for pollution management, their effective implementation will depend on strict compliance, regular monitoring, and collaboration between industries and regulatory authorities.

Since this is still in draft stage, it is expected that it will be more refined after incorporating the suggestions from industry stakeholders and environmental experts.

Please follow www.Lexplosion.in to stay updated on further development in this regard.

Written by: Amiya Mukherjee

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