IFC’s appraisal considered the environmental and social management planning process and documentation for the Project and gaps, if any, between these and IFC’s requirements. Where necessary, corrective measures, intended to close these gaps within a reasonable period of time, are summarized in the paragraphs that follow and (if applicable) in an agreed Environmental and Social Action Plan (ESAP). Through implementation of these measures, the Project is expected to be designed and operated in accordance with Performance Standards objectives.
PS1 – Assessment and Management of Environmental and Social Risks and Impacts
Renata PLC identifies and manages E&S risks and impacts associated with its operations through compliance with applicable national standards and E&S regulatory permits and requirements. The company has established an environmental and social management system (ESMS) commensurate with the operational E&S risks and impacts. The ESMS is compliant with national law and consistent with the requirements of IFC PS. The ESMS is certified per ISO 14001( Environmental Management ) , and ISO 45001( Occupational Health and Safety) .
The project will not fund any of the expansion of the Company’s existing manufacturing facilities. In line with the ESMS procedure for identification of E&S risks and impacts, the company regularly monitors and manages operational E&S risks and impacts. Renata PLC has obtained the required environmental and occupational health and safety (OHS) permits for its manufacturing facilities. These are approved as per the Good Manufacturing Practices (GMP) promoted by the World Health Organization (WHO) and regulated by the Bangladesh Drug Regulatory Authorities (DRA). The company implements an integrated environmental, OHS, and quality management system covering all operations. Renata PLC’s corporate policies are implemented through standard operating procedures (SOPs), work instructions, and training programs. The policy objectives are monitored through a system of key performance indicators (KPIs), and frequent reporting activities form the basis of continuous improvements throughout their operations.
Renata PLC’s Board of Directors monitors and reports on E&S performance to shareholders, regulators, and auditors. Day-to-day E&S functions are managed by a broad team of experienced professionals assigned to their Engineering, Health, Safety, and Environment (HSE), Production, Quality Assurance, and Human Resources departments. These managers and technical specialists are supported with appropriate E&S policies, resources, and training at the corporate and facilities levels to achieve their production and sustainable development objectives.
Renata PLC has documented emergency response plans for its manufacturing facilities aligned with the national law. Training for emergency preparedness and response and first aid is provided to all employees. The company also conducts regular fire and emergency drills. Renata PLC’s emergency response plan has considered potential impacts on nearby communities, and regular communication with local emergency public service agencies (fire, police, hospital).
Renata PLC’s monitoring and review activities are determined by both licensing requirements and its quality commitments as per Good Manufacturing Practices (GMP) certifications. As is common in the pharmaceutical sector, third-party certification and regulatory bodies audit the facilities periodically as part of surveillance protocols and GMP audits. Third-party and internal auditors conduct regular environmental and EHS monitoring activities of KPIs, including air and water quality, noise, lighting, workplace exposure to chemicals, injuries, etc. Environmental and OHS monitoring reports indicate compliance with the national law, WBG General EHS Guidelines (2007) and WBG EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing (2007).
PS2 – Labor and Working Conditions
Renata PLC has adopted HR policies and procedures compliant with the national law and consistent with the requirements of IFC PS2. HR policies and procedures cover recruitment, compensation, labor relations, induction and training, codes of conduct, annual performance evaluations, promotion, and disciplinary actions. The company complies with relevant legislative requirements, including prohibitions against sexual harassment and child or forced labor. Renata PLC’s workforce in February 2024 included 11,579 employees, of which 11% were female. Employees can raise their grievances through various channels. Staff are encouraged to approach HR directly with their concerns. Alternatively, they can do so anonymously through the telephone hotline. Managers also proactively seek staff feedback during frequent production and sales meetings. Renata PLC supports freedom of association and collective bargaining rights for their employees. The company currently has one collective agreement with a workers’ union representing a minority of staff.
As mentioned above, Renata PLC’s Occupational Health and Safety (OHS) management is ISO 45001:2018 (OHS) certified. It includes workplace risk assessment, mitigation and monitoring and reporting programs and procedures, and worker participation in accident prevention committees that address everyday risks from chemical exposure and ergonomic postures to falls and traffic accidents. Staff exposed to hazardous chemicals during manufacturing are provided with appropriate safety procedures and equipment, including monitoring devices, containment mechanisms, eye wash stations, showers, etc. Staff also undergo regular medical checkups. The company has not experienced any fatalities or major accidents in its history.
One potential PS2 gap identified during IFC due diligence is on workers engaged by third parties. Roughly 15% of Renata PLC's workforce consists of temporary workers contracted through accredited labor service providers as as needed. Renata PLC does not currently evaluate the E&S capacity of these third-party service providers before contracting their services. Nor do they currently audit these contractors’ compliance with national labor and working conditions and IFC PS2 requirements on things like minimum wages, maximum overtime, child labor, etc. Renata PLC will develop a Contractor Management policy to resolve this gap and audit their principal labor service providers’ compliance with the requirements of IFC PS2 and national law (ESAP#1). The Contractor Management plan will require labor service providers and their workers to receive induction training that explains Renata PLC’s Integrated Management System, code of conduct, and HR policies, including who to contact in case of grievances.
PS3 – Resource Efficiency and Pollution Prevention
Typical PS3-related issues associated with pharmaceutical manufacturing include i) air emissions, ii) hazardous materials, iii) solid and hazardous wastes, and iv) wastewater. of except for domestic wastewater treatment, the company Renata PLC manages these E&S risks and impacts consistently with the requirements and emission limits of WBG General EHS Guidelines (2007), WBG ESH Guidelines for Pharmaceutical and Biotechnology Manufacturing (2007), and national requirements.
The company uses high-efficiency particulate air (HEPA) filters in its heating, ventilation, and air conditioning (HVAC) system to ensure product integrity and meet air quality emissions standards. As part of the ESMS, Renata PLC has established an environmental monitoring plan that covers air emissions from process units and combustion sources. Monitoring results indicate compliance with the national air emission standards and WBG General EHS Guidelines (2007), WBG ESH Guidelines for Pharmaceutical and Biotechnology Manufacturing (2007) air emission levels. Raw materials and active pharmaceutical ingredients (APIs) are segregated and stored in warehouses following GMP requirements. The warehouses have designated areas for flammables and materials requiring controlled access and/or special temperature and relative humidity conditions. Warehouse staff have access to a database with Material Safety Data Sheets (MSDS) and safety information and equipment in an emergency.
Renata PLC’s solid and hazardous waste management procedures as part of its ESMS, covers waste reduction, segregation, treatment, and disposal through authorized companies. Waste is segregated according to hazardous, special treatment, or household categories. The former includes all potentially corrosive, reactive, explosive, toxic, flammable, or biologically infectious materials. The special treatment category includes electronic equipment, batteries, etc. The household category includes organic, inorganic, recyclable, and inorganic, non-recyclable materials. Segregated wastes are stored in well-ventilated and gated designated areas that were kept clean and not overfilled during IFC’s virtual site visit. Hazardous waste is monitored through periodic audits of authorized companies’ certification status and chain of custody procedures.
The company sources process water and sanitary water from onsite tube wells. Water for production undergoes extensive treatment and filtration. Effluents from production processes are treated through physicochemical and biological Effluent Treatment Plants (ETP). All three Renata PLC campuses use similar ETP technologies. They differ slightly in their treatment capacity (m3/hour) depending on the relative amounts of effluent produced through the different manufacturing processes employed at each site. This treated process wastewater is tested for compliance with national wastewater standards before being reused for watering plants and washing internal roads. Hazardous chemical sludge left over from this treatment process is disposed of by authorized contracts with local cement producers. Effluent monitoring results for Reneta’s three facilities indicate compliance with the national effluent limits standards and WBG EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing effluent levels.
Renata PLC’s facilities are in areas with no sewerage collection networks, so the company uses septic systems to treat and dispose of sanitary wastewater. The septic tanks are designed and installed in accordance with national regulations and are well maintained and cleaned to allow effective operation. The septic tanks are equipped with outlet baffles through which effluent goes to drain fields with sufficient soil percolation for the design effluent loading rate. The company will perform monitoring of the effluent quality and load. Based on the results, Renata PLC will prepare a sanitary wastewater water management plan with the proposal for improvement of the current sanitary wastewater management, which will include cost-effective technical solutions for the onsite sanitary wastewater treatment aligned with the national laws and standards and WBG General EHS guidelines (2007) and with an appropriate timetable for achieving applicable requirements. (ESAP#2).
Hazardous fuels are stored in government-approved multiple-layer storage tanks. Hazardous chemicals are stored in government-approved chemical storage facilities. Containers are clearly labelled, and handling, usage, and transportation of chemicals is managed in accordance with the applicable Material Safety Data Sheet (MSDS). All hazardous pharmaceutical waste is collected from different departments in color-coded double layer polybags and stored in segregated solid waste areas. Hazardous solid waste is sent to a government approved cement factory for incineration.
Renata PLC factories rely mostly on grid-sourced electricity for energy. Their plants in Bhaluka and Rajendrapur are facilities with up-to-date auxiliary systems equipped with energy and water-efficient features. Renata PLC has implemented several initiatives on resource efficiency (e.g., use of natural gas to power boilers, installation of solar panels, etc.) and has updated equipment such as fire suppression and sprinkler systems and backup generators with more efficient ones. In 2023, total greenhouse gas emissions (scope 1 and scope 2) from manufacturing (electricity and fuels) and fuels used for transportation have been estimated at approximately 65,000 tonnes CO2-equivalent per year. Additional GHG emissions are not expected to be significant due to the project.
PS4 – Community Health, Safety, and Security
Renata PLC’s plants in Bhaluka and Rajendrapur are in new industrial parks with limited proximity to communities. The Mirpur site shares some public access roads and boundary walls with neighboring residents. PS4-related risks are low because Renata PLC has largely anticipated and avoided adverse impacts on neighboring and affected communities. For example, they take required safety measures when transporting and storing hazardous materials, their transportation contractors effectively avoid road incidents and injuries, and they have defined mechanisms to receive and address concerns from the community, either through their webpage (https://renata-ltd.com/), social media apps, or at the reception area of each of the three campuses.
Physical security functions are subcontracted to a specialized security firm that is authorized and regulated by national government authorities. Current contract conditions provide for the presence of multiple armed security guards working in shifts around the clock. The company will conduct a security risk assessment of the armed security guards in their service to assess the risks posed by these security arrangements to those within and outside Renata PLC’s operations. This assessment will be guided by the principles of proportionality and good international practice in relation to hiring, rules of conduct, training, equipping, and monitoring of such workers, and by applicable law (ESAP#3).
