The Company has presented plans to address these impacts to ensure that the proposed Project will, upon implementation of the specific agreed enhancement/mitigation measures, comply with the environmental and social requirements, including Indian laws and regulations, IFC’s Performance Standards and the applicable World Bank Group (WBG) Environmental, Health and Safety (EHS) Guidelines. The information about how these potential impacts will be addressed by the Company is summarized in the paragraphs that follow.
PS 1: Social and Environmental Assessment and Management System
IFC’s assessment considered the Company’s management of its environmental, health and safety performance in the establishment and operation of its facilities; compliance with national and local permit requirements; and the Company’s engagement with local communities, regarding environmental, health and safety performance and corporate social responsibility.
- Environmental & Social Assessment:
The proposed expansion is being carried out within the existing industrial premises at Gagillapur and involves only installation of new machines within the existing buildings and the construction of a new warehouse. As such, detailed Environmental Impact Assessment (EIA) study was not required as per local regulatory requirement. However, the Company is in the process of procuring all the necessary regulatory permits for the expansion project. Accordingly, it will comply with stipulated measures to mitigate potential environmental impacts during construction and operation of the Project.
Management Systems and Certifications:
The Company has documented policies for Quality, Environment, and Safety. These corporate policies guide the operational procedures at each facility. The respective facility head and the engineering and EHS teams are responsible to develop and implement these site-level procedures.
Granules has established systems and SOPs to ensure that all of its facilities comply with international good management practices for the pharmaceutical industry, as well as with all relevant local laws and regulations. All Granules’ facilities are US-FDA approved and ISO 9001 certified. The Company is planning to obtain ISO 14001 certification for all its facilities by 2013. The EMS implementation is currently underway at Bonthapally. Similarly, the Company has plans to obtain OSHAS 18001 certification for its state-of-the-art Gagillapur facility.
- Organization, Monitoring & Reporting:
The Company has a dedicated EHS staff at each of the facilities, who report to the respective plant heads, who in turn report to CEO for any concerns on the EHS related matters. The 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’ senior management team, as well as externally to relevant regulators.
PS 2: Labor and Working Conditions
At present, Granules has a total full time workforce at all three plants of approximately 776 full time and an additional 1050 contract workers providing support services, such as catering, garden maintenance, and general cleaning and physical facilities maintenance. Security, mechanical maintenance and utilities operations are outsourced, which include effluent treatment plant (ETP), reverse osmosis (RO) unit, boiler, chilling plant operation as well as mechanical maintenance. Contractors provide 24x7 on-site support for these functions.
With the proposed expansion at Gagillapur facility, the Company expects to add a total of 175 new employees over the next 12 months.
The Company is making efforts to recruit more women into the workforce; women currently comprise approximately 15% of the total workforce in its quality control, quality assurance and research and development units.
- Human Resource Policy and Management
Documented HR manual and processes are in place for all the facilities which articulate the terms of employment and working conditions, including procedures for hiring, training, performance review, grievance mechanism, freedom of association, occupational health and safety, etc.
Granules HR practices are based on the philosophy of respect, empowerment and continuous development. Towards this, the Company has implemented numerous initiatives, such as the introduction of a robust Performance Management System, Plant Performance Incentive Scheme, Level-Grade Restructuring, Lean Recruitment Process and Training programs across all levels of the organization for developing and improving its human capital.
The Company offers a competitive benefits package for its employees, including an Employee Stock Ownership Plan (ESOP), which is offered selectively. Subsidized meals and transportation are provided at the Gagillapur site.
There is an active workers’ union at the Jeedimetla facility, as well as worker-management committees at each of the other plants, all of which include mechanisms for identifying, investigating and resolving any employee grievances.
- Occupational Health and Safety (OHS) and Training
A full time safety officer is responsible for managing OHS at each of its facility. A local doctor is available on call as needed. The Company has calendar for safety training and fire drills, which is rigorously followed and supporting documentation is maintained at the facilities.
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. The Company has a regular preventive maintenance program for all its equipments.
Worker’s Induction training and refresher courses are conducted for all employees on a regular schedule established for each plant and includes topics such as first aid, fire fighting, emergency preparedness and response, handling of hazardous chemicals, waste disposal management, etc.. Granules maintains 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.
According to the records presented by the Company, Granules did not have any major environmental, labor, occupational health and safety issues or accidents in the history of its operations.
While the overall OHS performance is satisfactory, fire exits/safety signage could be improved in some production areas. Moreover, housekeeping could be further improved to ensure that emergency fire exists are not blocked. For this purpose, Granules shall review its existing fire safety signage and housekeeping practices and draw up an improvement plan, as necessary as set forth in the attached Environmental and Social Action Plan (ESAP).
- Construction Labor Living and Working Conditions:
In order to ensure compliance with applicable labor laws including requirements for living and working conditions for contract’s construction labor, Granules will develop a standard format of related clauses to be included in all the future contracts. With this, Granules will require the contractors to comply with local labor laws as well as IFC PS2 requirements.
In additional, Granules will implement a formal and documented procedure for monitoring, by its own staff, the compliance by all the contractors on various contract clauses related to labor laws, occupational health and safety, provision and use of personal protective equipment (PPE) and living conditions of construction workers.
For the construction phase, necessary construction safety procedures and practices (such as fall prevention barriers, safety signage etc.) shall be implemented at site. While the contractors would be responsible for these and the general safety of their workforce (including provision of PPE) together with the on-site labor camps (if any), as part of the ESAP, Granules will ensure the adequacy of these provisions – through regular supervisions, in accordance with IFC PS2 requirements.
PS3: Pollution Prevention and Abatement
IFC’s assessment considered the Company’s operations with regard to resources consumption (water, energy, fuel) and its efforts to optimize resource inputs, waste minimization and management practices as well as the storage, handling hazardous materials used in the construction and operations of facilities.
- Legal Compliance
The Company maintains a compilation of all the statutory requirements and supporting documents (such as monitoring records). Necessary approvals and permits related to EHS are in place. The Company undertakes regular environmental monitoring as required by laws and maintains the records for the same, which confirm the compliance with local regulatory and IFC’s Performance Standards requirements.
- Water Supply:
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 treat water for use in the processing plant and drinking sources. RO treated water is tested daily in-house and by independent labs for Quality-Assurance (QA) purposes on regular basis. With the implementation of the Project, the daily water requirement is expected to increase by 30 m3/day at Gagillapur facility, from the existing requirement of approx. 300 m3/day.
- Energy Supply:
Electricity is obtained from the national 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 local regulatory 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).
Li-Br absorption chillers are used in chilling plants. Freon based individual / split air conditioners are provided in office blocks.
- Effluent:
All of Granules’ processing plants are equipped with both sewage treatment (septic tanks and soakaways) and process wastewater effluent treatment plants (ETPs). Going forward, Granules is intending to make the facility as zero discharge facility.
Currently, the domestic sewage at Gagillapur is treated and recycled for landscaping purpose. Process effluent at both Jeedimetla and Gagillapur is pre-treated to meet limits set by local regulators for discharge to government-owned Common Effluent Treatment Plants (CETPs) at Jeedimetla or Patancheru for final treatment. The effluents at Bonthapally are neutralized and disposed to CETP. Some quantities are recycled and used in the process.
The process wastewater is sent out by tankers and is monitored for around 20 parameters before it is accepted by CETP. A formal manifest system is in place for accurate monitoring and documentation.
- Solid and Hazardous Waste:
All Granules facilities follow the Company’s Standard Operating Procedures (SOPs) for the disposal of solid and hazardous wastes. The SOPs conform to all Indian laws and regulations, as well as WBG EHS Guidelines. Hazardous wastes from Jeedimetla and Gagillapur include ETP sludge, spent carbon and process wastes.
Non-hazardous wastes are collected at each site and disposed of at the common Treatment, Storage and Disposal Facility (TSDF) and secured landfill developed as a part of Hyderabad Waste Management Project.
The Company maintains records of waste volumes generated and methods of disposal in accordance with its SOPs; these are available for inspection by customers and regulatory authorities. The waste management 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.
PS4:– Community Health, Safety and Security
IFC’s assessment considered the Company’s operations with regard to the impacts on the nearby communities, including movement of vehicles to and from construction sites, fire / explosion risk due to on-site storage of gas and diesel (for backup generator), containment of dust, noise and other nuisance factors and use of security forces.
There is direct access to all the facilities from a highway and the impact of vehicular movements and traffic during facility operations on surrounding communities is minimal.
Both the Bonthapally and Jeedimetla facilities are located in industrial areas surrounded by other similar industries. In accordance with local regulatory requirements, signal boards 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 enjoys good relations with its neighbors at all of its facilities. At Bonthapally and Jeedimetla, Granules participates in joint fire and emergency drills with both the local fire brigade and other plants located in the industrial area on a regular basis.
A detailed On Site Emergency Plan is developed for 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.
The Company contracts with a security agency for 24 hour surveillance of the facility, with unarmed security guards at all its facilities. The Company has instructed security guards at each plant to refer any inquiries from the community to the relevant manager, up to and including the MD, as required given the nature of the inquiry.
On the basis of the above information, and by implementing the Environmental and Social Action Plan (ESAP), it is concluded that the Project has been designed and will be operated in compliance with IFC’s PS and relevant WBG’s EHS Guidelines.
