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
Policy: PPL has adopted a Health, Safety Environmental and Environment (HSE) Policy, that is broadly aligned with the objectives of IFC’s Performance Standards.
The company is a WHO cGMP certified manufacturer of pharmaceutical finished formulations with a number of regional GMP compliance certifications in Asia and Africa. The company holds ISO 9001:2015 certification for its quality management system. The company has established a health, safety and environment management system (HSEMS) across its business activities and is preparing for certification as per ISO 14001 (Environmental Management) and ISO 45001 (Occupational Health and Safety). As per ESAP#1, the Company will augment its existing HSEMS into an Environmental and Social Management System (ESMS), formalizing and updating the requirements for E&S procedures and plans in line with the regulatory framework, IFC Performance Standards, relevant WBG EHS Guidelines and GIIP. The ESMS will, at a minimum, include (i) procedures for conducting environmental, health, safety and social (EHSS) risk assessments at both the business and asset levels, aligned with the IFC Performance Standards and industry best practices, including consideration of supply chain risks, (ii) requirement for development of SOPs for managing EHSS risks and impacts across manufacturing, R&D, quality control, warehousing, and utility operations; (iii) ongoing monitoring, reporting and management review of ESMS implementation; (iv) EHSS training plan; (v) emergency preparedness and response; (vi) appropriate E&S organization, with responsibility and resource allocation; (vii) operational control procedures for occupational health and safety (OHS) including exposure control for potent compounds, aseptic operations, and laboratory safety; (viii) stakeholder engagement and community grievance mechanism consistent with the principles of transparency, accessibility, and responsiveness outlined in IFC Performance Standard 1.
Identification of E&S risks and impacts and management programs: The company 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, as part of the HSEMS, has established procedure for identification of E&S risks and impacts of its operations consistently with nation law and good international industry practices through use of standard tools such HIRA (Hazard Identification and Risk Assessment). The Company has prepared a list of critical areas, activities and capital machinery used in its operations to carry out HIRAs at regular intervals. As per ESAP#2, the Company will conduct HIRAs for all process areas (including production areas for hormones, cephalosporin, penicillin, vaccines, large volume parenteral, ophthalmic and other products), R&D centers, QC units and animal house, warehouses (including chemicals and solvent storage areas), utilities and others critical areas identified. The HIRAs will be updated on a regular basis to capture changes in processes, raw materials, and products; integrate emerging statutory requirements and relevant GMP / industry best practices; and drive continual improvement within the organization’s risk management system.
The company maintains legal register for its operations and the registers capture the key applicable permits and approvals (including Environmental Clearance from DOE, Factory License, Boiler Certificate, Fire License, Permission for use of acids, License for flammable and explosive materials storage and uses, etc.). The legal register includes information on the validity of each permit along the permit renewal calendar.
Standard Operating Procedures (SOPs) have been developed and implemented across the company operations for processing areas and products, quality control, operation and maintenance activities and facility management, warehousing and distribution, etc. In addition, as part of the HSEMS, specific SOPs have been developed to address key health, safety and environmental aspects such as site safety management, contractor safety, waste management, personnel hygiene and sanitation, fire safety, emergency preparedness and response, first aid, HSE risk assessments, audits and incident reporting, etc. These procedures aim to ensure a safe, efficient, and environmentally responsible work environment.
Organizational Capacity and Competency: The Company has established an HSE organizational structure with defined roles, responsibilities, and authority for implementing the HSEMS. At present, the Director-Projects and Plant Operations holds dual charge as Head - HSE and reports directly to the MD & CEO of PPL. In addition to HSE oversight, the Director-Projects and Plant Operations is responsible for managing production divisions, engineering operations (including utilities maintenance and project management), and warehousing. HSE aspects are currently coordinated by a Senior Executive-HSE (a mid-level function), supported at site by an HSE Executive, a Medical Officer, and a 15-member team drawn from the workforce (non-management) involved in fire safety, waste management, pest control, and other HSE related functions. The Director-HR & Admin oversees human resources, social and labor-related aspects, and stakeholder engagement, supported by a dedicated HR and administration team. The Director-Quality Operations & International Regulatory Affairs (IRA) is responsible for quality control and assurance, research & development (R&D), microbiology, and IRA. In line with ESAP#3, the Company will appoint a SeniorHSE resource with the overall responsibility for establishing, implementing, and maintaining the Company’s ESMS, ensuring compliance with applicable national regulations and international standards and IFC PS requirement and with a direct reporting line to the Director - Projects and Plant Operations.
Emergency Preparedness and Response: The Company has developed a comprehensive Emergency Preparedness and Response Plan (ERP) that addresses both onsite and offsite emergencies. The ERP provides specific procedures to be followed in the event of fire or explosion, chemical, diesel, or wastewater spills, hazardous chemical or gas leaks, medical emergencies, and climate-related incidents such as heavy rainfall, flooding, high winds, and cyclones. It also covers other potential scenarios, including earthquakes, structural collapse, electrical or utility failures, traffic accidents, bomb threats, worker unrest, civil disturbances, and national emergencies. A dedicated emergency response organization has been established within the Company, with clearly defined roles and responsibilities and external responders to be contacted during emergencies have also been identified. Regular emergency training sessions and mock drills are conducted to test preparedness and with participation from external agencies (Fire Service and Civil Defence Department).
Monitoring & Reporting: The company conducts annual internal HSE audits at its production facilities. The audits are conducted by a three member team consisting of representatives from HSE and engineering functions as well as relevant internal subject matter experts (SMEs). Based on the audit findings, corrective and presentive actions (CAPAs) are recommended and assigned to specific functions/departments for execution within specified timelines. External energy audits are also conducted at the production facilities by certified third party energy auditors. The energy audits are aimed at evaluating current operations in terms of energy efficiency and waste heat recovery and recommending improvements for cost and carbon reduction.
PS2: Labor and Working Conditions
Human Resource (HR) Policies and Procedures, Working Conditions and Terms of Employment: PPL has around 2500 employees, with around 3.5% of females in manufacturing roles. All the employees are hired directly by the company, and there are no third-party employees. In addition, the Company engages sales personnel and medical representatives for product promotion, market outreach, and customer engagement.
The company has established HR policies on relevant aspects for the employees, related to child labor, forced labor, recruitment, probation confirmation, performance management, compensation & benefits, leave, transfer, working hours, training, occupational health & safety, disciplinary procedures, aligning with the local law requirements and IFC. These policies are communicated via ‘employee handbook’ to all the executive staff and workmen. A dedicated HR team is responsible for managing human resources and the employees’ wellbeing. The company provides decent working conditions for all staff and workers. The factory shopfloors, office areas, utility areas, storage areas etc were noted to be well organized and kept in order. Company pays the employee’s salary regularly at rates higher than the applicable minimum wages, pays bonus twice a year, provides leaves and other benefits to workers.
Company rules defined for receiving accumulated PF amount after employee’s separation from the company have some gaps against the legislative requirements. The company will revise and implement the Provident Fund Policy to align with applicable statutory requirements. (ESAP#4)
Freedom of Association: The company does not have a documented policy on ‘freedom of association’. While there is no union at the factory, consultations with management and workers suggested that the workers have not attempted or requested to form any association in the past. Any alternative forum for collective discussions, in the form of a workers’ committee, is not present in the factory. The company has formulated a safety committee and canteen committee for specific purposes. The company will establish a formal policy on freedom of association and facilitate the formation & functioning of an effective ‘workers participation committee (WPC)’ and formulate a formal policy on freedom of association aligning with global standards. Members to the committee shall be elected and empowered in accordance with the applicable laws and regulations (ESAP#5).
Non-discrimination and Equal Opportunity: PPL has well defined policies on gender equality and the prevention of workplace harassment. The Policy against harassment addresses the prohibition of sexual harassment. Consultations with management and workers indicated that no incidents of sexual harassment have been reported within the Company premises to date. HR department is responsible to receive such complaints and resolve employees’ concerns. Going forward, the company will establish a dedicated, independent mechanishm in the form of a specific anti-sexual harassment committee to hear, manage and mitigate workers’ grievances and compliants on the issues of sexual harassment (ESAP #5).
Grievance Mechanism: PPL has established a detailed grievance handling mechanism and is well explained in the employee handbook. The documented mechanism defines grievance policy, responsibilities for the management, supervisor/team leaders/managers, complainant, and HR department. The mechanism has further defined the grievance process with suggested timeframes, resolution methods and covers the aspects of conflict of interest, confidentiality & privacy. An opportunity to appeal the decision of grievance process is also added to the overall grievance process. Suggestion boxes have been placed at different locations within the premises. Workers were noted to be aware of the existing grievance handling mechanism during the consultations.
Protecting the Workforce: Management has established policies on Child Labor and Forced Labor. There are no underage workers employed by the company. The HR department ensures the minimum age of all employees by verifying and keeping a age-proof record for all the employees. HR also ensures that any policy or procedure does not lead to any involuntary or forced work practice.
Occupational Health & Safety (OHS) Management: PPL has developed an OHS policy for its manufacturing operations. A dedicated OHS department with 20 members is deployed to ensure good, safe practices. Trainings are conducted throughout the year on specific OHS topics including, but not limited to fire prevention, work permits, HSE risk assessment, first aid, handling chemicals, PPE usage, safety signs & color coding, incident reporting, safety inspection, personal hygiene, forklift safety, etc.) for relevant participants. Mock drills are conducted to acquaint the staff with an emergency evacuation process. A Safety Committee is constituted at the factory to discuss and mitigates safety risks and issues. The Company has developed and implemented Standard Operating Procedures (SOPs) to address critical process-related risks and enhance occupational health and safety performance. In particular, the SOP for the receipt, storage, and handling of flammable solvents defines detailed safety and operational procedures for managing such hazardous materials within the warehouse. The procedure ensures personnel safety, compliance with applicable safety standards, and environmental protection through effective material handling, spill prevention, and quality control measures.
As a part of its Industrial Hygiene process, the Company has developed and implemented Contamination Control Strategy (CCS) for critical units like the Vaccine Facility, that poses health risks to the workforce. The strategy outlines specific approaches on contamination control and to maintain appropriate standard to ensure an adequate level of contamination control throughout the process. The strategy duly considers the overall approach for managing microbiological, particulate, endotoxin pyrogen and cross-contamination of products manufactured in the Vaccine Facility. The Company conducts pre-employment as well as annual medical examinations for all staff. These assessments include specific health investigations for personnel engaged in critical operations, such as Cephalosporin/Penicillin sensitivity or hypersensitivity tests, visual acuity (vision) tests, and hormone profile evaluations (including immunological tests for Progesterone and Estradiol), among others. The Company has also undertaken categorisation of molecules/drugs handles in their facility in accordance with occupation exposure levels (OEL). This has helped in aligning operational controls, and worker protection measures with inherent potency and toxicity of the substances handled.
The Company reports that there has been no fatal workplace accident or incident at any of the operating facilities. The company maintains an injury register and tracker to document all injuries and accident/incidents that have occurred within the company premises. A review of the injury register for 2024, indicates 31 medical injuries – most of them were noticed to be hand injuries and were treated in the company health center. All accidents and incidents were analyzed by the designated HSE team to identify the root causes and the appropriate action plan to mitigate as a result.
The operational units of the Company have valid fire permit from Bangladesh Fire Service and Civil Defence Department. The Company has implemented fire detection, alarm and firefighting systems included fire hydrant, and fire extinguishers, manual call points, fire exit signages, emergency lights and public address systems. An Emergency Preparedness and Response Plan has been developed the Company conducts fire and emergency preparedness training, and first aid training for its operational personnel. During the site visits, certain gaps were observed in PPL’s existing life and fire safety systems, notably, the absence of functional fire detection systems in critical areas such as the central warehouse and solvent storage sections. The Company informed that the extension of detection systems to such areas will be undertaken shortly. As per ESAP#6, The Company will conduct a third party Life and Fire Safety (LFS) Audit for all process and utility areas and implement the audits recommendations to address the gaps in a time bound manner
Supply chain: PPL sources APIs, excipients and primary and secondary packaging materials from its supply chain. APIs are sourced principally from China and India, excipients from Europe and packaging materials (PVC films, aluminum foil, ampule, vial, HDPE containers, syringes, etc.) from China, Indonesia, France, Thailand, India and Korea. PPL has developed a Supplier Screening Mechanism to identify, evaluate, and periodically assess its suppliers. Periodic vendor audits are conducted for selected vendors. The vendor appraisal questionnaire, in addition to techno-economic parameters, quality aspects, and business licenses, also includes E&S screening elements covering policies, management systems, certifications, utility management and HR aspects. The Company, as per ESAP#7, will update the Supplier Screening Mechanism to integrate specific assessment criteria and controls related to child labor, forced labor, occupational health and safety (OHS), and regulatory compliance.
PS3: Resource Efficiency and Pollution Prevention
Resource Efficiency: PPL operations consume resources such as electricity, natural gas, LPG, diesel, and water. Based on last year’s (2024’s) consumption, the annual resource consumption covering company facilities is around: 48.12 million (kWH) of electricity; 11.62 million m3 of natural gas, 17,280 Kg of LPG, 200 Kiloliter (KL) of diesel and approx. 722,000 cubic meter of water. The company sources electricity from national power grid power and has also installed rooftop solar generating 10 MWh per month. The water demand is sourced from ground water after securing necessary approvals.
The Company is actively engaging in initiatives to enhance both resource efficiency and energy conservation. These include measures such as installing heat recovery systems, utilizing rooftop solar energy, and reusing treated effluent. PPL operates seven (7) boilers, of which three (3) are exhaust gas boilers (EGBs) that generate steam by utilizing waste heat from captive power generators. The remaining four (4) boilers are dual-fuel units that use natural gas as the primary fuel and diesel as a secondary fuel, and are equipped with economizers and a central condensate recovery system. Additionally, the company is focused on optimizing water utilization through reuse of the treated effluent from the ETP for housekeeping and landscaping purposes. A significant volume of water generated from the moist heat sterilizers used in the Large Volume Parenteral (LVP) production process is also recovered and recycled within the system.
Greenhouse Gases (GHG) Emissions: PPL generates approximately 30,036 tonnes of CO2-equivalent emissions annually (Scope 1 and Scope 2), as determined through a third-party GHG emissions assessment. As part of its GHG emission reduction strategy, the company has implemented boiler heat recovery systems and installed rooftop solar plants. The company has set a goal to increase solar energy usage to cover 5% of the lighting load in the future
Air Emissions: Air emissions from the company’s operations are limited to particulate matter and volatile organic compounds (VOCs) from process areas, as well as emissions from gas generator stacks, emergency diesel generator (DG) stacks, and boiler exhausts. PPL’s manufacturing facility houses three (3) gas generators for captive power generation and seven (7) boilers. Diesel generators are installed as backup power sources; however, their use remains minimal due to the availability of dedicated grid power and the in-house captive generation system. The company has implemented specific emission control measures, including maintaining appropriate stack heights for generators, capturing VOC vapors through air extractors in fume hoods, collecting particulates using a series of filters (pre-filter, intermediate filter, and HEPA filter), and deploying dust collectors.
A regular air emission monitoring program is in place, under which stack emissions from boilers and DG sets are periodically tested by independent, accredited third-party laboratories. The latest stack emission monitoring results indicate compliance with regulatory standards. For the parameters tested, the results also meet the corresponding limits under the WBG EHS Guidelines.
Source noise levels are regularly monitored in process and utility areas. The results of noise monitoring indicate adherence to OSHA source noise standards.
Wastewater Treatment: The company operates an Effluent Treatment Plant (ETP) with a treatment capacity of 30 m³/day to manage wastewater generated from the production floors. Effluents from the vaccine, cephalosporin, and penicillin manufacturing units are first routed through neutralization basins for pre-treatment before being conveyed to the ETP. The existing ETP employs conventional primary and secondary treatment processes, and the quality of treated effluent is routinely monitored both internally and by the Department of Environment (DOE) Laboratory. Recent monitoring results indicate compliance with national discharge standards. For the parameters tested, the results also meet the corresponding limits under the WBG EHS Guidelines. The treated effluent is reused for car washing, landscaping, and general housekeeping within the facility premises, while the balance is discharged into public drains within the industrial area after meeting the applicable discharge standards. Sanitary sewage from the facility is currently managed through septic tanks with soak pits. To support ongoing and planned expansions, the company is enhancing its effluent treatment capacity through the construction of a new 600 m³/day ETP equipped with reverse osmosis (RO) process. The new system is designed to treat both industrial effluent and sewage, improve overall treatment efficiency, and increase the proportion of recycled water within the facility.
As part of ESMS implementation (ESAP#1) the Company will implement a plan for periodic monitoring of ambient air quality and emissions, ground water and treated effluent quality from its facility to demonstrate performance levels aligned with the applicable WBG EHS Guidelines.
Waste management: The company operations generate hazardous and non-hazardous waste which are managed as per a specific Waste Management Plan (WMP) developed by PPL. As part of the WMP, standards operational procedures have been put in place, outlining the processes for the collection, handling, storage, and disposal of waste, including specific procedures to deal with waste generated from process units and laboratories. The Company has entered into an agreement with Lafarge Holding PLC (a DOE approved agency) for disposing the hazardous waste generated in PPL – this includes rejected raw materials, pharmaceutical solid waste, ETP sludge and lube oil. The waste is utilized for coprocessing in cement manufacturing by Lafarge and a certificate of safe disposal is issued to the Company.
Hazardous chemicals are stored in a designated central chemical storage room, which is equipped with appropriate ventilation and segregation systems. Chemicals are stored in accordance with their compatibility classification and following established protocols to ensure safety and prevent cross-contamination. Chemical dispensing and usage take place under controlled conditions - typically within fume hoods, using appropriate PPEs and chemical storage cabinets to minimize exposure risks. Hazardous chemicals are disposed, neutralized or decontaminated before discharge in ETP as per standard operating procedures. This ensures compliance with regulatory requirements and promotes safe and environmentally responsible chemical management practices.
PS4: Community Health, Safety and Security
The company’s manufacturing units are located within an established industrial zone and have been designed, constructed, and are operating in compliance with the national building and fire safety codes. The company has obtained factory license from Department of Inspection for Factories and Establishments (DIFE), trade license from the Gazipur Municipal Corporation and license to manufacture drugs from the Directorate General of Drug Administration (DGDA). The company has established regular infrastructure and an equipment safety related inspection regime in compliance with local regulations and GMP standards. SOPs are also in place for routine testing and verification of contamination control systems (e.g. conducting leakage tests of HEPA filtration systems using aerosol photometers and aerosol generators to ensure system integrity and performance).
The Company has adopted required safety measures when transporting and storing hazardous materials. The company raises driver’s awareness on defensive driving and speed limits during traffic to address issues of local traffic increase and associated impacts on community health and safety. The manufacturing units have adequate access roads and are typically located close to the highways/wide roads with basic infrastructure available for attending to emergency scenarios.
Security Personnel: The company has arranged for deployment of unarmed security personnel across its manufacturing units, after conducting necessary background checks. The company reports no security incident in the past involving workforce, community members and other stakeholders. The company briefs security personnel about policies on prevention of child labor to be verified among contractor/third party workers at gate and provides training on basic safety, first-aid, fire safety and emergency response.