Founded in 1977, Glenmark Pharmaceuticals Limited ("Glenmark" or "the company") is a leading Indian manufacturer of generic pharmaceuticals. The company engages in the development, manufacturing, and marketing of pharmaceutical products and active pharmaceutical ingredients (APIs) in India and internationally, and offers products in a range of therapies including respiratory, dermatology, cardiovascular and oncology.The company has a global presence in more than 60 countries and 17 manufacturing facilities across India, United States (US), Argentina and Czech Republic. Of the 13 manufacturing facilities in India, five are API manufacturing facilities and located at Mohol, Kurkumbh and Aurangabad (in Mahrashtra), and Ankleshwar and Dahej (in Gujarat); the remaining are formulation facilities in Baddi and Nalagarh (in Himachal Pradesh), Nashik and Aurangabad (in Maharashtra), Indore (Madhya Pradesh), Sikkim and Goa. In addition, all overseas facilities are formulation facilities.The company is also involved in the discovery of new chemical entities and new biological entities and has five Research and Development (R&D) centers across India and Switzerland.The proposed investment is upto $75 million through quasi-equity instruments to be used for; (a) expanding manufacturing capacity (primarily in India); (b) building R&D capacity for new products (including in India); and (c) reduce debt so that internal accruals can be deployed to R&D ("the project").
OVERVIEW OF IFC'S SCOPE OF REVIEW
Considering the nature of the proposed investment (i.e. a corporate investment) and footprint of the company, the focus of IFC's review was to understand the capacity, maturity and reliability of the Glenmark's corporate environmental and social (E&S) management systems so as to effectively manage its E&S performance; the latter also included assessment of the company's ability to ensure current and ongoing compliance with IFC's Performance Standards (PSs). To understand typical E&S risks and impacts associated with the pharmaceutical manufacturing operations which need/will need to be managed, the E&S performance of a sample of Glenmark's existing pharmaceutical operations in India were reviewed during the appraisal.In 2013, IFC had evaluated operations of one of Glenmark's facilities in Goa for a proposed financial partnership, however, the project was not completed. The information available from that appraisal also provided a background to IFC on E&S management at Glenmark.Taking the above into account, IFC's appraisal consisted of reviewing company information related to technical, environmental, health and safety (EHS) and social matters including: corporate EHS policies and procedures, EHS performance reports submitted by facilities, management systems information (internal audits, objectives and targets, procedures), regulatory permits, EHS organization charts, environmental and workplace monitoring reports, safety audits, on-site emergency response plans, EHS training records and human resource (HR) related records. The appraisal also included site visits (in May 2016) to the operational API manufacturing facilities at Ankleshwar and Mohol, and a formulation facility at Baddi. Further, discussions were held with management at the respective facilities (representatives from EHS, HR, engineering and production), as well as the corporate office including Head - EHS, and individuals from HR and the supply chain management teams.
IDENTIFIED APPLICABLE PERFORMANCE STANDARDS**
While all Performance Standards are applicable to this investment, IFC's environmental and social due diligence indicates that the investment will have impacts which must be managed in a manner consistent with the following Performance Standards.PS 1 - Assessment and Management of Environmental and Social Risks and ImpactsPS 2 - Labor and working conditionsPS 3 - Resource Efficiency and Pollution PreventionPS 4 - Community Health, Safety and SecurityIf IFC's investment proceeds, IFC will periodically review the the project's ongoing compliance with the Performance Standards
As the proposed investment is for general corporate purposes and though capital expenditure will be undertaken by the company, no new construction envisaged for the project requires land acquisition. In any event even in case of new facilities, the land is generally either allocated by the industrial area authorities or purchased through willing buyer-willing seller transactions. Consequently PS5 (Land Acquisition and Involuntary Resettlement) is not applicable. Similarly, the type of risks and impacts envisaged in PS6 (Biodiversity Conservation and Sustainable Natural Resource Management), PS7 (Indigenous Peoples) and PS8 (Cultural Heritage) do not apply. Screening and assessment of issues identified in future projects against PSs requirements will be completed though through the company's E&S management systems.
ENVIRONMENTAL AND SOCIAL CATEGORIZATION AND RATIONALE
This is a Category B project according to IFC's Policy on Environmental and Social Sustainability because a limited number of specific environmental and social impacts may result which can be avoided or mitigated by adhering to generally recognized performance standards, guidelines or design criteria.Key E&S risks and issues associated with this Category B Project include: the company's capacity and ability to implement robust environment, health and safety management systems both at corporate level and facilities level; engagement with local communities in accordance with local requirements and IFC Performance Standards (PSs); assurance of fair, safe and healthy working conditions in compliance with local regulatory requirements and relevant PSs; resource efficiency of the operations (mainly water and energy); management of organic solvent usage and emissions of volatile organic compounds, other gaseous compounds and particulates; monitoring and management of wastewater treatment and discharge; solid/hazardous waste management; life and fire safety management including emergency preparedness and response; community safety; and sourcing of raw materials and supply chain management and auditing.
**Information on IFC's Policy and Performance Standards on Environmental and Social Sustainability can be found at www.ifc.org/sustainability
ENVIRONMENTAL AND SOCIAL MITIGATION MEASURES
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 the implementation of these measures, the project is expected to be designed and operated in accordance with Performance Standards objectives.
PS 1: ASSESSMENT AND MANAGEMENT OF ENVIRONMENTAL AND SOCIAL RISKS AND IMPACTS
Environmental and Social Assessment: Considering that the API manufacturing facilities are covered under the category of bulk drugs and intermediates, excluding drug formulations, as defined in the Indian environment impact assessment rules, Glenmark is required to conduct Environmental and Social Impact Assessment (ESIA) studies for any major expansion at the existing API facility or for any new API facilities. The company had completed such an ESIA study as per applicable legal requirements for establishment of its API facility at Dahej (in 2011-12) and obtained the required environmental clearance from the State Level EIA Authority of Gujarat.Additionally, for approval of any proposed capital expenditure (CAPEX), Head - EHS provides inputs on any risks associated with such projects as well as support in identifying potential solutions from an EHS perspective. For any change in the manufacturing process in API facilities, the required EHS studies (e.g. Hazard Operability (HAZOP)) are completed by a cross-functional team including the representative from the EHS team.To strengthen the environmental assessment processes and as set forth in the ESAP, the company will develop a standard procedure and terms of reference (ToR) for any future ESIA studies (for new projects) or E&S due diligence (for prospective acquisitions) to ensure alignment with IFC PSs requirements and this will also include ensuring adequate integration of social impacts into the risks and impacts identification process. The procedure will also cover preparation and implementation of an E&S management program (ESMP) based on the ESIA/E&S due diligence studies.Policy and management programs: Glenmark has a corporate environmental, health and safety (EHS) policy as well as a separate occupational, health and safety (OHS) policy. The EHS Policy is applicable to all Glenmark operations including all overseas facilities. All major Glenmark facilities in India have an environment management system (EMS) implemented and certified as per ISO 14001 requirements. Implementation of the EMS was noted to be adequate at all the visited facilities. The remaining facilities will evaluate implementing similar systems in the future.Currently Glenmark's Indore facility has implemented an OHS management system certified compliant as per OHSAS 18001 requirements and the same is under implementation at all the other facilities. The company plans to complete the implementation of OHS management system and obtain the certification by March 2018 for all the major facilities.Until such time as the OHS management systems are certified, all facilities will continue to implement the current corporate safety management system which has about 60 standard operating procedures (SOPs).Additionally, most of Glenmark's facilities are approved as per Good Manufacturing Requirements (GMP) requirements of the various countries including the United States Food and Drug Administration (USFDA), United Kingdom (UK)'s Medicines and Healthcare Products Registry Agency (MHRA-UK), Brazilian Health Surveillance Agency (ANVISA), South Africa's Medicines Control Council (MCC-SA), Pharmaceuticals and Medical Devices Agency, Japan (PMDA-Japan), World Health Organization (WHO) as well as Ministry of Health of various African, Asian and CIS countries.Identification of Risks and Impacts: A risk assessment is carried out for OHS aspects as per Glenmark's SOP on "Risk Assessment and Safe Working Procedure." Under the SOP, all facilities complete the hazard identification and risk assessment (HIRS) as per the defined procedure. Any new activities or modifications have to be included in the HIRA as per the SOP. Also, HAZOP studies are completed for any change in the manufacturing processes. Environmental risks are identified as per legal requirements and the aspect-impact identification procedure under the ISO 14001 requirements.Organizational Capacity and Competency: At the corporate level, the Head - EHS is responsible for EHS management of all Glenmark operations and reports to the President - Global Operations. The company also has an EHS council which is chaired by the President - Operations and includes Executive Vice Presidents, Head of Quality Assurance and HR.There is an EHS team at each of the facilities comprising of EHS Managers/coordinators, safety officers and other staff who are responsible for implementing facility specific EHS systems and sustainability projects and reporting back to corporate as part of the reviews and assessments. Each facility also has a facility level/central safety committee as well as in some cases, area/departmental safety committees (for larger facilities) which review safety performance on an ongoing basis.Emergency Preparedness and Response: In accordance with local requirements, Glenmark provides fire safety equipment at its facilities based on the nature of risks involved. The fire safety system at visited facilities included portable fire extinguishers, fire hydrant systems with dedicated fire water storage, water and foam monitors, fire alarms as well as fire tenders (at Ankleshwar). Required number of personnel was noted to be trained in fire safety and emergency response at the visited facilities. There were emergency response kits (e.g., spill kits, self-contained breathing apparatus boxes, and fire proximity suits) well identifiable and located at various locations, based on expected risks, in the facilities visited by IFC.Glenmark has prepared on-site emergency response plans (OSEPs) for all its facilities covering various types of emergencies. The assembly points are identified and marked. Emergency exits are clearly marked and have emergency lighting provision. However, areas of improvements were noted in marking of evacuation routes in the visited API facilities. Thus as set forth in the ESAP,Glenmark will identify facilities where such improvement is required (in addition to the visited facilities) and prepare and implement a plan for improvement of marking the evacuation routes in all facilities with timelines when such is to be completed by.Though its facilities do not fall under Major Accident Hazards (MAH) requirements, the API facility at Ankleshwar and Dahej share information on storage of chemicals and nature of risks posed with the district authorities, which prepare off-site emergency plans. Regular emergency response drills, including evacuation drills and fire drills, were noted to be conducted for different emergencies, as required by the OSEPs.Taking into account the hydrogenation plant at the Mohol facility, as per the ESAP, Glenmark will complete a Quantitative Risk Assessment (QRA) for this plant through an external, qualified consultant to define the associated risks. Based on the QRA, required preventive measures will be implemented and the OSEP (discussed above) will be updated accordingly. In case required, the information will be shared with the local authorities for their disaster management/off-site emergency response planning.Monitoring and Review: All facilities conduct regular environmental monitoring including ambient air quality, stack emissions, effluent quality, ambient noise, water quality, etc. in order to ensure compliance with the applicable legal requirements and standards. The monitoring parameters and their thresholds are governed by the consent conditions specified in the CTO (Consent to Operate) and stipulated by respective State Pollution Control Boards which also vary within facilities. As currently there are differences in parameters monitored between facilities, as part of the ESAP, Glenmark will develop and implement a corporate EHS monitoring procedure which will specify minimum parameters to be monitored, monitoring frequencies for all facilities dependent on the type of sources (e.g., process stacks, boiler stacks, effluent treatment plants, fugitive sources) and monitoring (e.g., ambient air quality, stack and fugitive emissions, treated effluents), and the definition of thresholds that signal the need for corrective actions. In addition to applicable legal requirements, the monitoring thresholds will include thresholds specified for ambient air quality, stack emissions including process and utility emission stacks, and effluent quality in the applicable World Bank Group (WBG) General EHS Guidelines and EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing. The latter requirements will be based on a feasibility assessment of such analysis in India and applicability to Glenmark's operations. Regular monitoring will be conducted for these parameters and corrective actions taken as necessary.Also, at each facility, regular EHS inspections as well as an internal audit (required under EMS/OHS management system) are carried out. In terms of external audits, third party certification bodies audit the facilities periodically as part ofthe management system certification/surveillance protocols. The regulatory agencies of various countries (mentioned above) also carry out GMP audits on a periodic basis. Management review meetings (MRMs) and safety committee meetings are conducted regularly at each facility to review EHS performance. Additionally, Head - EHS conducts an audit of EHS performance at the various facilities on a regular basis.Further, EHS reporting is part of the monthly EHS Scorecard and Management Information System (MIS) which is reported by the facilities to the Head - EHS as well as to facility management. The MIS and scorecard cover data on environmental monitoring parameters, production, waste generation, status of licenses, results of inspections by authorities, summary of discussions of safety committee meetings, summary of internal EHS inspections, as well as leading and lagging indicators on OHS. Head - EHS summarizes the facility level data and presents it to the EHS council on a six monthly basis.The company will ensure implementation of E&S management systems and procedures as described above to any new facilities.
PS 2: LABOR AND WORKING CONDITIONS
As on March 31st, 2016, Glenmark employed about 12000 employees globally with 4000 involved in manufacturing operations. In addition, about 2500 contract workers are employed globally in Glenmark manufacturing facilities. The contract workers are typically involved in loading/unloading/movement of materials, secondary packing, cleaning/housekeeping, utilities (as helpers), security and gardening operations.Human Resource (HR) Policies and Procedures, Working Conditions and Terms of Employment: Glenmark has documented HR policies and procedures which are available on the company's intranet such that they are accessible to employees. All employees sign a contract with the company at the time of employment. The contract describes the working conditions and terms of employment. The employees are provided all the legal benefits including provident fund (PF), employee state insurance (ESI) coverage, festival bonus, gratuity, leave etc. and are covered under the personal accident policy as well as a medical insurance policy. Based on the review of the data at visited facilities, the working conditions and terms of employment for the employees was noted to be meeting the legal requirements.Non-discrimination and Equal Opportunity: Glenmark has included principles of non-discrimination and equal opportunity policy within its recruitment policy.Prevention of Child and Forced Labor: To prevent use of child labor, all facilities collect age proof documentation at the time of recruitment of the worker. IFC's review identified no instances of child labor or forced or bonded labor.Freedom of Association: Glenmark does not restrict freedom of association of its employees. Currently, the Nashik facility has an employee union and the company has signed a collective bargaining agreement with the union. No other facilities currently have a union.Grievance Mechanism: The employees can raise their grievances through various forums provided by the company. The company follows an "open door" policy and, if required, the employees can approach senior management to raise grievances. Also, there is a feedback mechanism called "Bindaas Bol," through which the employees can submit their suggestions/feedback/grievances anonymously. A few of the facilities have processes to provide opportunities for employees to have direct interaction with the facility head and HR (in small groups) where the employees can discuss their grievances. Finally, there are town halls at each facility on a monthly basis by facility management and on a quarterly basis by senior management of the company. As set forth in ESAP, the company will document a grievance mechanism which will include the existing procedures and will be aligned with PS2 requirements. The same will be communicated to all employees.The company has also formulated and implemented a prevention of sexual harassment policy in line with regulatory requirements.The HR policies of the company were noted to be aligned with PS2 requirements and are expected to be similarly applied to any new facilities.Occupational Health and Safety (OHS): As discussed above under PS1, currently the Indore facility has implemented a certified OHS management system (as per OHSAS 18001 requirements) and the same is under implementation at other facilities. The company plans to complete the implementation of OHS management system and obtain the certification by March 2018 for all its major facilities.Until OHSAS 18001 is implemented at all the operations, all facilities will continue to implement the corporate SOPs. Though Glenmark is in the process of ensuring complete implementation of SOPs at all its facilities, some of the key SOPs were noted to be already implemented at all visited facilities including on risk assessment and safe working procedures, safety induction and training, permit-to-work (for working at height, hot work, entry into confined spaces, etc.), fire safety and emergency response (emergency planning, fire escape routes/exits/lighting, evacuation drills and training), PPE usage, accident reporting and investigation.Based on the observations at the visited facilities, all facilities conduct risk assessment for their operations and undertake required safety measures. HAZOP studies are regularly conducted for new projects or any changes in the processes at the facilities and especially at API facilities. Safety induction is provided to employees, workmen, contract workers and visitors. Regular safety trainings are provided to employees as well as contract workers. Required safety equipment is provided including PPE depending on hazards related to the type of task being performed and the production unit, including hard hats, safety shoes, safety glasses, masks or respirators (including self-contained breathing apparatuses) and hearing protection. PPE usage was noted as being adequate at the visited facilities. The use of partitioned workplace areas with differential air pressure was observed at the visited formulation facility. High efficiency particulate air filters were present at the facility as per GMP protocols. Safety signage was noted to be provided, as needed, in English or other local languages as applicable at the facilities. Regular health checkups are conducted for both employees and contract workers, based on an analysis of workers' exposure to workplace hazards. Workplace monitoring, including noise, particulate and volatile organic compounds (VOCs) is carried out as per statutory requirements. The results were noted to be in compliance with the applicable national standards and WBG EHS guidelines.All facilities have facility/area/department level safety committees which review safety performance on a regular basis. Safety performance is also reported to the facility management as well as Head - EHS on a monthly basis including on accidents/incidents, near-misses, first-aid cases, EHS training, fire incidents.Specifically in API facilities, the company provides well-equipped Occupational Health Centers (OHC), staffed with doctors, along with ambulance which cater to both employees and contract workers.All OHS incidents/accidents are reported as per the corporate SOP on reporting systems, which clearly defines procedures to report OHS incidents/accidents and their timing. Based on the available date for financial years 2013 to 2016, the company has had 8 and 96 injuries with loss of work at its formulation and API facilities respectively. All these incidents/accidents were noted to be investigated along with root cause analysis and corrective actions. The lost time injuries frequency rate (LTIFR) (per 200,000 man-hours) for last three years is reported to be 0.05 and 1.29 for formulation and API facilities and 0.46 on a combined basis. The LTIFR is lower than the incident rates noted in the average incident rate for pharmaceuticals and medicine manufacturing (employment size of 1000+) i.e. 1.3 for 2014 as reported by Bureau of Labor Statistics, USA.Third Party Workers: As mentioned above, Glenmark hires contract workers at its facilities which are supervised by the facility's relevant management teams (on HR, engineering, production). Prior to start of their activities in the company's facilities, the contractors sign an agreement with the plant EHS team which include safety instructions with financial penalty clauses in case any instructions are not followed by contract workers. All contract workers are provided EHS induction before start of the work, and tool box talks are undertaken on a regular basis. Also, all contractors follow the permit to work system for any hazardous activity performed by them. For routine activities, the contract workers are trained and follow relevant SOPs. To strengthen contract worker safety practices, specific assessments have been initiated by the Head - EHS based on which improvement programs have been initiated at the Goa, Ankleshwar, Indore and Dahej facilities last year, and the same is being initiated at Nashik, Baddi, Nalagarh and Sikkim facilities this year.The facility HR departments monitor contractor compliance with various statutory compliance requirements on providing wages, working hours and benefits to their workers. The payment to contract workers is made through bank accounts or in case of cash, in presence of HR representative from Glenmark. Glenmark also requires contractors to provide evidence of their compliance every month before clearance of their bills. The wages and overtime payment for the contract workers are as per statutory requirements, however, as per the ESAP, the company will prepare a detailed plan involving multiple solution themes such as automation and manpower reorganization with an objective to improve worker efficiency and optimize their working hours. The company's current objectives of implementing "Track and Trace" system would be an integral part of this plan.The plan shall be shared with IFC for agreement and implemented within the agreed timelines.Supply Chain: Glenmark contracts reputable raw material suppliers. Many of these suppliers have facilities which are approved by US and European regulators. The company has a dedicated supply chain team which manages these relationships. The suppliers are screened by the quality assurance (QA) team before being contracted. The contract includes a clause on compliance with applicable legal requirements on EHS. The QA team also conducts regular audits at their facilities (annual for key raw material suppliers and contract manufacturers) to review their production practices. The company had sent a specific EHS communication to all their suppliers which includes the company EHS policy as well as basic EHS expectations.To strengthen E&S management of its supply chain, as part of the ESAP, Glenmark will develop a corporate policy and procedure on supply chain management and include specific requirements on EHS including prevention of child labor, forced labor and ensuring safety of workers in the contracts for its raw material suppliers and contract manufacturers. The procedure will also describe various activities including vendor communication, and self-evaluation for screening as well as on an ongoing monitoring along with agreed consequences of non-compliance. The procedure will be implemented within timelines agreed with IFC.
PS 3: RESOURCE EFFICIENCY AND POLLUTION PREVENTION
Resource Efficiency: Glenmark monitors both total as well as specific energy and water consumption. The resource efficiency goals are fixed at the corporate level by Head - EHS and distributed to the facilities. The goals are included in the key results areas (KRA) of the EHS managers/coordinators as well as other departments like production and engineering. The facilities also fix these goals under their EMS as their objectives and targets. However, currently the processes and timelines of fixing resource efficiency goals under the EMS and KRA process are not aligned across facilities. As per the ESAP, the company will develop and implement a corporate procedure on resource efficiency planning and monitoring which will align the existing processes, define timeline of fixing the goals and describe monitoring and reporting processes related to resource efficiency.To achieve the resource efficiency goals, all facilities identify energy and water improvement projects in consultation with the Head - EHS. Some of the key projects undertaken by the company's facilities include: (a) replacement of lamps with energy efficiency LED lighting at a few existing facilities and providing LEDs at new facilities; installation motion sensors in wash rooms and lobbies; (c) providing variable frequency drives (VFD) on motors to draw current based on load variation for air handling units (AHU) and chilled water pumps; (d) optimizing air changes per hour and blower revolutions per minute (RPM); (e) recovery of hot air from dehumidifiers to reduce heating requirement; (f) installation of new electrical panels to improve the power factor; (f) installation of temperature controller to cut-off cooling tower fans; (g) installation of cyclic timer on ACs, auto on/off for air curtains and timers for pumps and exhaust fans; (h) recovery and re use of steam condensate; and (i) optimization of air conditioning systemsAir Emissions and Ambient Air Quality: The main emissions sources at Glenmark facilities are the process emission stacks and vents, and the utility stacks including boilers, hot water generators and back-up diesel generators. At the API manufacturing facilities, volatile organic compounds (VOCs) emissions are condensed and solvents are recovered through solvent recovery plants (mainly a distillation process), or sent to authorized service providers for recovery. All process vents are provided with alkali or acid scrubbers.Ambient air quality and process emissions are regularly monitored at every facility. Process and power/steam generation stack emission monitoring results and ambient air quality monitoring results provided are compliant with the limits specified for the facilities by the relevant State Pollution Control Boards and with the National Ambient Air Quality Standards (NAAQS). They are also in line with the WBG EHS Guidelines, although the final set of parameters to be monitored is still to be defined. As indicated under PS1, going forward Glenmark will develop and implement a corporate environmental monitoring program which will ensure consistent monitoring plans at the facilities and monitor compliance with national limits as well as applicable WBG EHS Guidelines. This program will be applied to new facilities as required.Water Consumption and Wastewater Discharges: The source of water for consumption at Glenmark facilities is predominantly groundwater and in some cases, like the Ankleshwar facility, the industrial area water supply. The water is pre-treated to achieve the required quality for process uses. The total annual water consumption at Glenmark is reported to be 0.53 million liters. With the company's efforts on water conservation, both the absolute and specific water consumption are reported to be reducing over the last three years.Glenmark has adopted a zero discharge policy for wastewater. At all its API facilities (except Kurkumbh), the high chemical oxidation demand (COD) and low COD effluents are segregated. The low COD effluent is treated through physico-chemical effluent treatment plant (ETP) followed by biological treatment and reverse osmosis (RO). The High COD effluent is first treated through a stripper (for recovery of solvents) and multi-effect evaporator (MEE). The condensate from the MEE is mixed with the low COD effluent whereas the remaining slurry is dried in an agitated thin film dryer (ATFD) and waste salts are landfilled at government approved treatment, storage and disposal facilities (TSDFs). The treated water from the RO is utilized for boilers, cooling tower make-up and gardening. At the Kurkumbh API facility, the effluent is currently discharged to a common effluent treatment plant (CETP) and Glenmark is currently in the process of installation of the abovementioned treatment process.At formulation facilities, the effluent is treated in a primary and secondary treatment process followed by tertiary filtration. In case de-activation is required (e.g. at hormone plant at Goa formulation facilities), the same is carried out before discharging the effluent to the ETP. The treated effluent is then used for gardening and greenbelt irrigation.Quality of treated effluents are regularly monitored through external agencies certified by the Ministry of Environment and Forest (MOEF). The quality of treated effluents at the visited facilities (for the tested parameters) was noted to be in compliance with the national standards as well as WBG EHS Guidelines. As indicated under PS1, going forward Glenmark will develop and implement a corporate environmental monitoring program which will ensure consistent monitoring plans at the facilities and monitor compliance with national limits as well as applicable WBG EHS Guidelines. Where non-compliance is identified, the company will then implement corrective measures to address these.Storm water from clean surfaces is collected and discharged through separate drainage systems. Rainwater harvesting systems have been installed at a number of Glenmark facilities.Waste Management: The major streams of hazardous waste generated at Glenmark facilities include ETP sludge, inorganic salts from MEEs, spent solvents, used oil, electronic waste, off-specification products, and date expired/discarded drugs. The wastes were noted to be stored in designated and appropriately designed storage areas (except spent solvent where some areas of improvements are identified and discussed below). All hazardous waste streams are sent to government licensed service providers or TSDFs for disposal. To reduce the waste sent for landfilling, the company has initiated co-processing of its off-specification/expired medicine from one of its formulation facilities in a cement kiln where it is used as alternate fuel for energy generation. In FY 2014-15, 200 MT of hazardous waste was sent to cement kilns for co-processing, and the company is currently exploring the scalability of this initiative to other facilities.The non-hazardous waste streams like plastic, metal and packaging waste are segregated and sold to external agencies for further recycling. At a few facilities, organic waste (like canteen and garden) is composted on-site through vermi-composting.Hazardous Materials Management: Production processes at Glenmark facilities require the use of a number of hazardous chemicals in various quantities especially the API facilities where production processes require the storage of a number of chemicals in bulk including different solvents (e.g. toluene, methanol, methylene dichloride, iso propyl alcohol). The solvents are stored in a licensed tank farm area, located in a properly secured location, where solvents are stored in aboveground or underground storage tanks (ASTs/USTs). At Ankleshwar, the solvents were noted to be stored in ASTs whereas at Mohol, they were stored in USTs. The USTs were noted to be tested for their integrity. In addition, solvents are also stored in drums both at API and formulation facilities in designated storage areas.Hazardous material management was found to be adequate at the facilities visited by IFC. Based on the observations at the visited facilities, Glenmark has implemented measures to manage the use, storage and handling of hazardous material according to good industrial practice. Hazardous materials handled at the production facilities were properly assessed and classified for associated hazards and their inventories were known by staff. Material Safety Data Sheets (MSDS) were found to be properly maintained and readily available in all production facilities. Appropriate signage was provided. Secondary containment as well as other safety provisions, including spill control and response were provided as needed, at the visited facilities for their storage. Training in chemical handling and emergency situations is provided to both staff and contract workers.However, areas of improvements were notedat a few locations in the storage of solvents and spent solvents (in drums) in terms of ensuring their storage in areas with roofs and secondary containment at the visited API facilities. As per the ESAP, Glenmark will identify all such locations and prepare and implement a corrective action plan for improving solvent storage at all its facilities. The plan will be implemented within timelines agreed with IFC.GHG emissions: Based on available data on electricity and fuel consumption, total annual direct GHG emissions were approximately 30,000 tons of CO2 equivalent (tCO2e) while total indirect GHG emissions were 75,000 tCO2e. The specific direct and indirect GHG emissions are reported to be 2.4 tCO2e and 6.3 tCO2e, per ton of product, respectively in FY 2014-15.To reduce the GHG emissions and substitute use of fossil fuels, two of the facilities (Nashik and Mohol) have switched the fuel for steam generation from diesel to bio-diesel. Also, the company has installed 100 kWp solar power plant at its R&D center at Mahape, Navi Mumbai in 2015-16. Further, the company has entered into an agreement to purchase electricity from a hydropower plant in place of coal based power in 2015-16 for the same center. The company has also evaluated geothermal cooling as alternate to cooling tower at two locations and the project is under consideration.
PS 4: COMMUNITY HEALTH, SAFETY AND SECURITY
Emergency Preparedness and Response: Glenmark's facilities are typically located in a notified industrial area and all visited facilities were located in such areas. As per the applicable legal requirements, the API facilities of the company provide required information to and coordinate with local authorities for offsite emergency preparedness and response programs. The facilities also participate in the offsite emergency mock drills organized by the authorities. The visited facilities at Baddi and Ankleshwar are member of Mutual Aid Response Group (MARG) created by respective District Administrations through which nearby companies coordinate and provide mutual support in disaster management in case of an emergency.Hazardous Materials Management and Safety: The company receives the needed raw materials including hazardous chemicals through contracted specialized transport service providers. The company has communicated EHS requirements to its transport service providers which include - (a) proper maintenance of vehicles; (b) proper documentation of the vehicle and driver like driving license, pollution under control (PUC) certificate; (c) no carrying sources of fire on the vehicles like stove, kerosene oil, match box, gas lighter; and (d) maintaining MSDS and Transport Emergency (TREM) cards for the transportation of hazardous materials and solvents. A basic check is performed on-site when the vehicles arrive to ensure compliance with these requirements. For unloading of hazardous materials and solvents on-site, the instructions have been documented and displayed. All solvent tankers are earthed and spark arrestors are provided before unloading. As per the company will document specific instructions for its transport service providers and drivers in case of hazardous material transportation accidental scenarios. Also, if possible, the company will perform awareness sessions and offsite drills for the transport service providers and drivers.Security Personnel: Unarmed security personnel are employed at Glenmark facilities through security contractors. The company briefs security personnel about policies on child labor and provides training on basic safety, first-aid, fire safety and emergency response.
Incorporated in 1977 by late Mr.Gracias Saldanha, Glenmark is an Indian pharmaceuticals company headquartered in Mumbai. Glenmark has a global presence across emerging and developed markets, and has 17 manufacturing facilities globally, of which 13 are in India, 2 in other emerging markets and 2 in developed markets. Of the 13 manufacturing facilities in India, a vast majority are in Tier-2/3 cities and two are located in Low-Income States (LIS) of Madhya Pradesh and Sikkim. The Company offers products across a range of therapies including respiratory, dermatology, cardiovascular, diabetes and oncology.
Glenmark is publicly listed on Bombay Stock Exchange (BSE) and National Stock Exchange (NSE) in India. Saldanha family, the Promoters of Glenmark, hold 46.48% in the Company and public shareholders hold the remaining 53.52%, as of March 31, 2016.
ACCOUNTABILITY MECHANISM OF IFC
The Compliance Advisor Ombudsman (CAO) is the independent complaint mechanism and fact-finding body for people who believe they are likely to be, or have been, adversely affected by an IFC or MIGA- financed project. If you submit a complaint to the CAO, they may assist you in resolving a dispute with the company and/or investigate to assess whether the IFC is following its own policies and procedures for preventing harm to people or the environment. If you want to submit a complaint electronically, you can email the CAO at CAO@worldbankgroup.org. You can learn more about the CAO and how to file a complaint at http://www.cao-ombudsman.org/
Name: Jason D’Souza
Designation: Vice President, Corporate Strategy and Investor Relations
Address: Glenmark House,
B D Sawant Marg,
Email id: mailto:Jason.Dsouza@glenmarkpharma.com