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.
- Social and Environmental Assessment and Management Systems:
Granules has provided details on the systems and SOPs it has established to ensure that all of its facilities comply with international good management practices for the pharmaceutical industry, as well as with all relevant laws and regulations of the Government of India and the State of Andhra Pradesh (AP). The company has provided copies of all current required permissions for each facility, including Environmental Clearances from the Ministry of Environment and Forests (MoEF), Government of India (GOI), No Objection Certificates (NOCs) from the Andhra P Pollution control Board (PCB), and both Consents to Establish and Consents to Operate from APPCB. The company is in the process of obtaining all of the requisite clearances and permissions for the tablets plant at Gagilapur, prior to the commencement of operations there. All of Granules’ operational facilities have received approval from both the India Food and Drug Administration (FDA) and from the US food and Drug Administration (USFDA) to produce both active pharmaceutical ingredients (APIs) and pharmaceutical formulations intermediates (PFIs; blends of single or multiple APIs).
The company has a corporate level Environment, Health and Safety (EHS) Officer, as well as plant level EHS staff in each of the facilities. Plant level reporting is conducted daily on key aspects of EHS performance (e.g., effluent testing, maintenance of hygienic conditions, and reporting of lost time injuries). These reports are aggregated into monthly summaries which are provided both internally to Granules’ management team, as well as to relevant regulators (e.g., APPCB). The company is in the process of preparing for ISO14000 certification at all of its plants: the first ISO audit will be carried out at the Bonthapally plant on July 2007. Granules has committed to having all of its plants ISO 14001 certified by 2010.
- Labor and Working Conditions:
At present, Granules has a total full time workforce at all three plants of approximately 490 full time and an additional 400 contract workers providing services such as catering, garden maintenance, and general cleaning and physical facilities maintenance. Depending on the mix of products manufactured at the new Gagilapur tablet plant, the company expects to add a total of 40-60 new employees over the next 12 months, including an expanded Research and Development (R&D) team and additional Quality Control (QC) and Quality Assurance (QA) and Regulatory Affairs (RA) staff. In response to its growth and expansion, Granules is in the process of formalizing its Human Resources (HR) policies and procedures with respect to all aspects of HR activities, including developing a formal system to assess and report on individual employee performance annually. The company is in the process of recruiting a full time, experienced HR professional to manage a corporate level HR department and systems. There is an active union at the Bonthapally facility, as well as worker-management committees at each of the other plants, all of which include mechanisms for identifying, investigating and addressing employee grievances. The company meets or exceeds Government mandated minimum wages for all relevant labor categories. Moreover, given the competitive nature of the Pharma sector AP, the company has established a salary and benefits package for its technical staff that exceeds the market average, including a medical reimbursement policy as part of its compensation package, and Employee Stock Ownership Plan (ESOP), which is provided selectively. Subsidized meals and transportation are provided at the Gagilapur site. The company has reviewed PS2 and confirmed that its labor practices comply with all of the requirements of PS2, and has committed to ensuring that the formal HR policies, procedures and systems it is currently developing also will be consistent with PS2. The company is making efforts to recruit more women into the workforce; women currently comprise approximately 30% of the total staff in its QC, QA and R&D units.
Granules recently constructed a new, automated plant at its facility at Bonthapally, to supplement production at the original plant there, which dates to 1987. In January 2007 the company’s Board of Directors voted to phase out production at the original Bonthapally plan by July 1, 2007. Since then, Granules management team at Bonthapally has engaged in lengthy and detailed discussions with the union at Bonthapally regarding the shutdown, which is expected to result in a net loss of approximately 150 jobs. The company and the union are in the process of negotiating a voluntary retirement scheme (VRS), the details of which are expected to be finalized in May. The scheme will be presented to Bonthapally workers at that time. Granules has confirmed that there will be no involuntary retrenchment. The company is also in discussions with some of its contractors regarding the possible hiring of workers who opt for the VRS. The company and union will document fully the details of the VRS, the names and designations of all employees who are eligible for the scheme, the names of all workers who opt to take the VRS package, as well as whether the workers were taken on by any of Granules’ contractors.
The company has in place stringent policies and procedures for ensuring that both workplace hygiene and occupational health and safety (OHS) conditions in all of its facilities meet recognized international standards. Granules has had no significant incident in DPL’s history. The company has a detailed On Site Emergency Plan at each facility 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. Granules has hard and soft copies of all relevant material safety data sheets (MSDS) on hand at each plant, and conducts detailed training for all workers who may be exposed to hazardous materials. The company will release the MSDSs to the local hospitals and include the local hospital in the emergency response drills on an annual basis. The Jeedimetla facility uses significant amount of organic solvents for different synthesizing processes. In accordance with the provisions of the Factories Act, these solvents are stored in underground storage tanks in an un-built area of the facility with limited access, which has approved by both the APPCB and local fire authority. Smoking, photography and the use of mobile phones are not permitted in this open area or inside any part of the plant. Movement of solvents within the plant is completely automated and Granules has detailed SOPs in place to prevent and detect the release of chemicals and protect workers health and safety. Liquid materials are handled through pumping system using flameproof pump sets, stored in underground tanks and used through closed pipelines. Solid materials are handled by trained persons with suitable PPE and stored in HDPE bags and kept in a well ventilated area. Other relevant OHS SOPs include a Work Permit system for carrying out all hot works, required use of flame proof equipment in hazardous areas, spark arrestors fitted to all storage tanks, provision of lightning arrestors throughout all of the plants, and earthing for all equipment. A regular preventive maintenance program is adhered to for all equipment and mock emergency drills are conducted on a regular schedule at all facilities. The company will include volatile organic compounds (VOCs) as workplace air quality monitoring parameters at Jeedimetla. Spent solvents are sent to licensed solvent handler for recovery or disposal. The Bonthapally plant uses para amino phenol in products. Since phenol volumes used are relative large, testing of process effluent for phenol will be undertaken in future. Life and fire safety (L&FS) equipment meets both all regulatory standards and international good management practice. All L&FS equipment is regularly inspected, tested and serviced.
Workplace OHS is further managed by provision of all indicated personnel protective equipment (PPE) including safety helmets, respiratory masks, goggles and gloves, and ensuring – through daily monitoring by EHS staff – that the use of PPE is enforced throughout each plant. Granules has ensured that all equipment is equipped with appropriate safety guards, has ding anti-vibrating pads for diesel generator (DG) sets and fluid bed processors to reduce noise levels to accepted safe levels, and installed dust collection systems and centralized HVAC systems in all working areas to maintain adequate ventilation and prevent cross-contamination. Induction training and refresher courses are conducted for all employees on a regular schedule established for each plant and monitored by the EHS staff on health and safety topics such as first aid, fire fighting, emergency preparedness, handling of hazardous chemicals, waste disposal management.
- Pollution Prevention and Abatement:
All of Granules’ facilities receive water from a combination of municipal and private sources. Each plant has an on-site reverse osmosis (RO) plant to pretreat water for use in the processing plant and drinking sources, as well as storage capacity to ensure adequate water supply for operations. RO water supplies are tested daily in-house and by independent labs for QA purposes. All of Granules’ processing plants are equipped with both sewage treatment (septic tanks and soakaways) and process wastewater effluent treatment plants (ETPs). Process effluent at both Jeedimetla and Gagilapur is pre-treated to meet limits set by APPCB to discharge to a government-owned Common Effluent Treatment Plants (CETPs). Effluent at Bonthapally is also pretreated to meet APPCB limits but is 100% recycled and utilized internally for processing and other purposes. Granules is in the process of expanding the ETP at Bonthapally to handle larger volumes of process waste water in future. Treated washing water at Gagilapur is used for non-processing purposes and landscaping.
All Granules facilities follow the company’s SOPs for the disposal of solid and hazardous wastes. The SOPs conform to all Indian laws and regulations, as well as WBG guidelines. Non-hazardous wastes are collected at each site and disposed in compliance with the provisions of the Hyderabad Waste Management Project at a Common Treatment, Storage and Disposal Facility (TSDF) and secured landfill. The company maintains records of waste volumes generated and methods of disposal in accordance with its SOPs; there are available for inspection by customers and regulatory authorities. This municipal service has dedicated vehicles for transporting wastes from industries to the facility. Empty drums and other raw materials containers are returned to the supplier for re-use. Hazardous wastes from Jeedimetla and Gagilapur include ETP sludge, spent carbon and process wastes. These also are disposed of in accordance with the requirements of the Hyderabad Waste Management Project at a common TSDF and secured land fill.
Electricity is obtained from the grid with backup supply from high speed diesel generators (DGs.) Emissions from the DG sets are tested annually; recent resulted provided by Granules indicate that DGs at each facility meet all relevant APPCB requirements and WBG limits for key parameters (NOx, SO2 and particulate matter [PM]). Each facility also has a boiler, fueled either by coal or furnace oil. Boiler emissions are also tested annually by third parties. Results from the most recent tests indicate that boilers meet relevant APPCB requirements and WBG limits for key parameters (NOx, SO2 and PM, with the exception of PM emissions at Bonthapally which slightly exceed WBG limits (109 mg/Nm3 as against the limit of 100). Granules will provide the results of the next round of tests to IFC to confirm the recent results; if these tests indicate that the PM limit is not being met, additional emissions controls will be installed to ensure compliance with WBG limits.
- Community Health, Safety and Security:
Both the Bonthapally and Jeedimetla facilities are located in industrial development areas surrounded by facilities in other similar industries. As part of its EHS management system, Granules prepares on-site emergency preparedness and response plans (EPRPs) for each facility, including policies and procedures to prevent community exposure to fire, explosions and hazardous materials under both normal and emergency scenarios. The EPRPs are based on risk assessment and analysis, as well as the requirements of the IDAs and APPCB. Entry to and exit from each plant is controlled carefully by 24-hour security personnel. Granules engages a private company to provide security services at all plants; contract provisions include guidelines on how security personnel shall interact with neighboring communities and industrial facilities surrounding the facility. The Granules management team has reviewed PS4 and indicated that the facility will comply with its requirements in full. In accordance with APPCB requirements, signboards are posted at the entrance to each Granules facility listing the hazardous materials in use, hazardous materials generated, and effluent and air emissions monitoring results. The company has instructed security guards at each plant to refer inquiries to the relevant manager, up to and including the MD, as required given the nature of the inquiry. The company enjoys good relations with its neighbors at all of its facilities. At Bonthapally and Jeedimetla, Granules participate in joint fire and emergency drills with both the local fire brigade and other plants located in the IDA on a regular basis.
- Land Acquisition and Involuntary Resettlement:
As noted above, Granules does not intend to acquire add ional land in the context of this project. Nonetheless, the company will review its internal land acquisition procedures against the requirements of PS5 (Land Acquisition and Involuntary Resettlement) and to amend these procedures if necessary to ensure future compliance with PS5 requirements.
