IFC requires that this document is made available through the World Bank InfoShop and to the locally affected community no less than 30 days prior to project consideration by the IFC Board of Directors. The Summary of Project Information (SPI) also provides details of where the ERS has been made available to the locally affected community. The SPI must be sent to World Bank InfoShop no less than 30 days prior to project consideration by the IFC Board of Directors.

This is a Category B project according to IFC’s Procedure for Environmental and Social Review of Projects because a limited number of specific environmental impacts may result which can be avoided or mitigated by adhering to generally recognized performance standards, guidelines or design criteria. The review of this project consisted of appraising technical and environmental information submitted by the project sponsor. The following potential environment, health and safety impacts of the projects were analyzed. - General production situation; - Air emissions and ambient air quality; - Liquid effluent treatment and discharge; - Hazardous materials handling; - Solid/hazardous wastes handling and disposal; - Occupational health/safety and emergency response plans; - Animal experiments; - Environment, health and safety programs; - Community relationship and social issues.

The sponsor has presented plans to address these impacts to ensure that the proposed project will upon implementation of the specific agreed measures, comply with the environmental and social requirements - the host country laws and regulations and the World Bank/IFC environment and social policies and the environmental, health and safety guidelines. The information about how these potential impacts will be addressed by the sponsor/project is summarized in the paragraphs that follow. - DPL facility in Kalyani, West Bengal, India was acquired from Pfizer for API production in 1996. DPL added a new plant building in this facility for synthesizing oncology products manufacturing. DPL owns a sterile formulation facility in Baddi, Himachal Pradesh, India. DPL is working on FDA approval for Kalyani facility. - DPL uses paclitaxel, extracted from yew tree, for manufacturing cancer drug. The present yew tree sources are from the plantation in Nepal, as well as other sources from the Netherlands and Scandinavian countries. DPL will make sure in the future to purchase yew tree products with certificates from Forest Stewardship Council (FSC), Programme for Endorsement of Forest Certification (PEFC), or Convention International Trade in Endangered Species (CITES), or from the countries signing the Cartagena Protocol and with local government approval, wherever applicable. - There are boilers at both manufacturing facilities in India for steam generation. DPL only monitors particulate matter (PM) and SO2, which meet the Indian regulatory requirements. However, the PM parameters exceed the World Bank Group (WBG)/IFC guideline limits. The ambient air qualities meet both Indian regulatory requirements and WBG/IFC guideline limits, with the exception of PM which exceeds the WBG/IFC guideline limit. DPL will start monitoring NOx for the air emission, and take applicable approaches to reduce PM levels in both air emission and ambient air. - The domestic wastewater generated onsite is discharged to the municipal sewerage system. There is no process wastewater generation at Baddi facility. The process wastewater generated at Kalyani facility is treated onsite before discharged to the regional wastewater treatment system. The liquid effluents meet both Indian regulatory requirements and WBG/IFC guideline limits. DPL will start to monitor organic halogen in the liquid effluents from Kalyani facility. - The Kalyani facility uses significant amount of various organic solvents for different synthesizing processes. These solvents are stored in a special storage facility onsite with limited access, which is approved by local fire department. There are internal procedures for handling the solvents to minimize the solvent release to the environment and protect operators’ health. The spent solvents are sent to licensed solvent handler for recovery or disposal. DLP will include volatile organic compounds (VOC), methylene chloride, chloroform, and hexane as workplace air quality monitoring parameters. - DPL’s solid waste consists largely of packing materials (drums, jars, bottles). Where possible, these are returned to the supplier for re-use. Both dry wastes and sludge from the effluent treatment plant are collected by a local contractor on a monthly basis for disposal at a municipal landfill. The hazardous wastes are also collected onsite and sent to licensed contractor for disposal. - The company has in place stringent policies and procedures for ensuring the occupational health/safety issues in all the facilities to meet recognized international standards. There is no significant incident in DPL’s history. The company has a detailed On Site Emergency Plan for responding to fires, chemical related explosions, and accidental releases of hazardous substances The company conducts drills according to the Emergency Plan on a regular basis, in collaboration with the local fire brigade. DPL will provide material safety data sheets (MSDS) in prevailing local language for all the positions where the hazardous materials are used. The company will also release the MSDS to the local hospitals and include the local hospital in the emergency response drills on an annual basis. - There are environmental, health, and safety (EHS) managers onsite for each facility. DPL is working to set up a company-wide environmental management system (EMS), with the vice president of DPL leading the EHS issues, combining and systemizing various existing environmental, heath, and safety rules/procedures. - Both the Kalyani and Baddi facilities are located in light industrial areas. The company enjoys good relations with its neighbors. The company meets all national statutory requirements in terms of the salaries and benefits it provides its employees. Its salaries are highly competitive and it provides a medical reimbursement program, leave/travel allowance, and group pension plan to all employees. - If the company purchases lands for new plants or expansions in the future, the company agrees to follow the applicable WBG/IFC policies and guidelines. The operations for the new plants should also meet the EHS requirements of local regulatory agencies and applicable WBG/IFC policies and guidelines. - The company develops a Corrective Action Plan (CAP) as an attachment of this Environmental Review Summary (ERS), which consists of separate action plans and reflects the requirements of this ERS. The company will implement the CAP during the Project preparation and execution, and ensure the requirements of this ERS are satisfied according to its schedules.

The following supporting document provides further details of environmental and/or social issues.

Accordingly, IFC concludes that the proposed project will meet the applicable World Bank/IFC environment and social policies and the environmental, health and safety guidelines upon successful implementation of the agreed mitigation measures.

IFC will evaluate the project's compliance with the applicable environmental and social requirements during the lifetime of the project through the following methods: - Review the annual monitoring reports (AMRs) prepared for the project; - Check the implementation status of any measures contained in the Corrective Action Plan; - Periodic site supervision visits will also be conducted, if necessary