The Central Pollution Control Board (CPCB) has issued draft guidelines for the pharmaceutical industry aiming to regulate and mitigate its environmental impact. Stakeholders and the general public have until February 5, 2025, to provide their feedback on the proposed guidelines. Suggestions can be submitted via email to designated CPCB officials or sent to the IPC-I Division of CPCB in Delhi.
Key Highlights of the Draft Guidelines
Classification of the Pharmaceutical Industry
The industry has been categorized into:
- Pharmaceutical Formulation
- Vaccine Manufacturing
- Ayurvedic/Unani Medicine
- Pharma R&D
These industries are further classified based on pollution levels into Red (highly polluting) and Orange (moderately polluting) categories. Sub-categories have also been defined, based on processes and fuel types used, such as cleaner or gaseous fuels.
Environmental Impact and Pollution Potential
The draft emphasizes the significant environmental footprint of pharmaceutical manufacturing, including air and water pollution, hazardous waste generation, and resource consumption. Industries involved in the production of Active Pharmaceutical Ingredients (APIs) are particularly highlighted as high-pollution contributors.
Siting and Environmental Compliance Criteria
Industries must maintain minimum distances from sensitive areas, including water bodies, educational institutions, and archaeological sites. For example, Red Category industries must be located at least 500 meters away from surface water bodies and settlements.
Industries are mandated to allocate 33% of their plant area for greenbelt development, with plant density ranging from 1,500 to 2,500 trees per hectare.
The draft emphasizes robust mechanisms for managing:
- Wastewater: Industries are required to implement Effluent Treatment Plants (ETPs) and adopt Zero Liquid Discharge (ZLD) systems to recycle wastewater.
- Air Emissions: Measures to reduce volatile organic compounds (VOCs) and hazardous air pollutants, such as benzene and methanol, include advanced control systems and leak detection programs.
- Hazardous Waste: Industries must ensure proper storage, disposal, and recycling of hazardous waste, adhering to the Hazardous and Other Wastes Rules, 2016.
Regulatory Framework
The guidelines reiterate compliance with existing laws under the Environment (Protection) Act, 1986, and emphasize obtaining clearances such as Consent to Establish (CTE) and Consent to Operate (CTO) from State Pollution Control Boards.
The CPCB encourages active participation from industry stakeholders, environmental experts, and the public to refine these guidelines.
For detailed information, the draft is available on the CPCB website. Comments and suggestions can be sent to the following email addresses:
- dinabandhu.cpcb@nic.in (Sh. Dinabandhu Gouda)
- rnpankaj.cpcb@nic.in (Sh. Raj Narayan Pankaj)
