All the existing facilities including the under-commissioning pharmaceutical facility are located within designated industrial area and land was purchased from the industrial area authorities more than 10-15 years back through open market commercial transactions. The new vaccines unit under construction at Shameerpet is abutting the existing boundary of the bio-tech park Phase II and approval for conversion to manufacturing zone has already been obtained by the company. This land was also purchased through open market commercial transactions, on a willing buyer willing/seller basis from private landowners in 2016. Land purchase did not involve any involuntary resettlement or economic displacement and hence, PS5 (Land Acquisition and Involuntary Resettlement) is not applicable. Similarly, since all the facilities are located in or adjacent to well-developed specialized industrial zones on the outskirts of the urban center; the risks and impacts envisaged under PS6 (Biodiversity Conservation and Sustainable Natural Resource Management), PS7 (Indigenous Peoples) and PS8 (Cultural Heritage) are not present and hence PS6-PS8 do not apply to this investment.

 This is category B project according to IFC’s Policy on Environmental and Social Sustainability because the project will result in limited potential adverse E&S risks and/or impacts that are few in number, generally site-specific, largely reversible and readily addressed thorough mitigation measures. 

Key E&S risks and issues related to this project include: adequate E&S assessment of the impacts of the project; company’s capacity and systems to manage social, and EHS aspects of its operations in compliance with legal requirements as well as IFC PSs and WBG EHS Guidelines; assurance of fair, safe and healthy working conditions as per the local regulatory requirements and relevant IFC PSs; management of wastes (particularly hazardous and biomedical waste), air emissions and liquid effluents; emergency preparedness and response; community health, safety & security and managing E&S risks in the supply chain.

 Environmental and Social Assessment and Management Systems: 

The company has procured all necessary EHS related regulatory approvals for its Shameerpet facility (the “facility”) and complies with the permit conditions. Accordingly, it has received the Consent for Operation (CFO) from the State Pollution Control Board (SPCB) and also obtained other required permits such as factories license, license for storage of furnace oil (FO) and high speed diesel (HSD) for operation of boilers and diesel generators respectively, authorization for handling and disposal of hazardous waste and bio-medical waste. The Shameerpet facility is registered with Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) under Animal Welfare Division of Ministry of Environment, Forests and Climate Change for research on small animals (mice and guinea pigs) for commercial purpose.  

Policy and Management Programs: 

The company has a corporate EHS policy applicable to its vaccine division and the company’s existing vaccine manufacturing facility at Shameerpet has developed and implemented an Integrated Management System (IMS) comprising of environment management system (EMS) certified as per ISO 14001 requirements and OHS management system certified as per OHSAS 18001 requirements. 

The IMS includes 35 Standard Operating Procedures (SOPs) related to provisions on safety (e.g. hazard identification, risk assessment or HIRA, emergency preparedness and response, incident reporting, safety review, work permit system, spill control etc.) and environment (e.g. handling of bio-waste, detoxification of empty containers, management of biological agents and biological risk assessment). 

The facility in Shameerpet is WHO pre-qualified and undergoes audit every 4 years by WHO for renewal of license. The facility follows the Good Manufacturing Practices (GMP), which is a system that ensures that products are consistently produced and controlled according to quality, safety and hygiene standards as per the requirements stipulated by various countries. BioE has received GMP accreditation from various countries such as Colombia, Vietnam, Iran, Egypt, Kenya, Tanzania and Uganda and is also a member of various international associations such as GAVI and Pan American Health Organization. 

The company has set-up Institutional Animal Ethics Committee (IEAC) as per the CPCSEA guidelines for the animal house facility. Clinical trials are conducted strictly as per the approved procedure stipulated in Drugs and Cosmetics Act, 1940 requiring prior approval from Drug Controller General of India and in accordance with International Council for Harmonization guidelines. 

As included in ESAP#1, the company will develop a corporate EHS/sustainability policy applicable to all its facilities. The policy will articulate company’s commitment to comply with the applicable laws and regulations as well as compliance with IFC Performance Standards. As included in ESAP#2, the company will also develop IMS manual for its new vaccine manufacturing facility including various SOPs and implement IMS manual at the new vaccine manufacturing facility being constructed. 

Organizational Capacity and Competency: 

At the corporate level, Deputy General Manager (Safety Health and Environment or SHE) is responsible for EHS management of all operations who reports to the Chief Operating Officer (Vaccines Division) and is supported by Senior Manager (Environment & SHE - Statutory); Deputy Manager (Operations Safety) and Assistant Manager (Employee Outreach). 

In addition, there is an SHE coordinator for each of the facility, who is responsible for implementing the facility specific EHS systems and programs and reporting back to the corporate team as part of the reviews and assessments. Each facility also has a facility level safety committee which reviews safety performance on an ongoing basis. The company plans to extend the scope of the SHE committee to the new vaccine manufacturing facility once it is operational.

Emergency Preparedness and Response: 

In accordance with the local regulatory requirements, the facility has provided fire safety equipment based on the nature of risks involved and the specific GMP requirements. The fire safety systems included portable fire extinguishers, fire hydrant systems with dedicated fire water storage, smoke detectors and fire alarms. Required number of personnel was noted to be trained in fire safety and emergency response at all 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 at the facility. 

Based on the identified hazards and risks, an on-site Emergency Response Plan (ERP) has been developed by the company for each facility. Accordingly, potentially hazardous areas have been identified and evacuation routes and assembly points have been designated and clearly marked. Regular emergency response drills, including evacuation drills and fire drills, were noted to be conducted for different emergencies as required under the Factories Act. The company will develop and implement a similar emergency preparedness and response programs for the new vaccine manufacturing facility. 

The company has agreed that the Engineering, Procurement and Construction (EPC) contractor for the new vaccines manufacturing facility at Shameerpet will prepare an ERP covering various emergencies such as natural disasters like floods and earthquakes and specific hazards like fire, chemical spill, electrical shock and other environmental pollution incidents.  

Monitoring and Review: 

Environmental monitoring at all facilities is governed largely by the permit requirements and is undertaken for ambient air quality, stack emissions (boiler and diesel generator sets), ambient noise levels and treated wastewater quality. The monitoring parameters and their thresholds are governed by the conditions specified in the CFO by SPCB. In addition, water consumption is monitored and reported and accordingly water charges calculations. 

Like all the operating facilities, Shameerpet facility also report to the senior management on standard safety related key performance indicators (KPIs) such as (lost time accidents, recordable injury, first aid cases, etc.) and safety inspections are done on a monthly basis. Safety committee meetings are conducted regularly at each facility to review EHS performance and safety audits are carried out at on a regular basis by an internal team. The same monitoring protocol will be replicated for the new vaccine manufacturing facility to be constructed once its becomes operational. 

BioE will be required to report to IFC annually on environmental and safety performance of the operations via the Annual Monitoring Report covering all its operational facilities. 

The company has published its first sustainability report of vaccines division for 2015-2016 (compliant with Global Reporting Initiative G4) covering various aspects such as governance and ethics, environmental (energy, water, emissions, effluents and waste), social (occupational health and safety, training, product responsibility), stakeholder engagement and supply chain.

  BioE has a total workforce of 2532 employees as of April 2017 and also employs an additional 1292 contract workers in its facilities. The contract workers are typically involved in housekeeping, security, gardening and packing operations (around 120 workers work at the stable near Gaganpahad). Women make up 9% of the total company workforce and 20% of the contract employees workforce. The number of employees is expected to increase by 500 and number of contract workers is expected to increase by 300 once the two additional facilities (pharma and vaccines unit at Shameerpet) are commissioned. 

HR Policies and Procedures, Working Conditions and Terms of Employment: 

BioE has documented HR policies and procedures compiled in the form of service rules which are available on the company’s intranet such that they are accessible to employees. The HR policies include procedures on recruitment, leave, mediclaim, retirement, exits and entry of employees and use of mobiles. 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, gratuity, leave etc. and are covered under the personal accident policy as well as a medical insurance policy. Additional benefits like free on-site canteen and transportation services are available to employees. The company has also formulated and implemented a prevention of sexual harassment policy in line with regulatory requirements. 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: 

The company has articulated the principles of non-discrimination and equal opportunity within its recruitment policy.  

Prevention of Child and Forced Labor: 

The company has corporate policies against hiring of workers below the age of 18 years and forced labor. These requirements also apply to all the temporary workers hired by third party contractors. The same is reiterated in the ‘ten principles of supply chain sustainability’ that the company follows and requires its suppliers to follow too, which includes following principles on human rights (support and respect the protection of human rights) and labour (uphold the freedom of association, elimination of forced labour, abolition of child labour and elimination of discrimination). 

Freedom of Association: 

The company does not restrict freedom of association of its employees. Currently, the facilities at Azamabad, Gaganpahad and Patancheru have an employee union and the company has signed a collective bargaining agreement with the union. 

Grievance Mechanism: 

The company does not have a formal and documented grievance redressal procedure in place although the company has provided suggestion boxes where any employee can submit their suggestions/feedback/grievances which will be then discussed by a committee comprising of HR representatives within 90 days. As included in ESAP #3, the company will develop a formal grievance redressal mechanism to address and resolve grievances and also covering contract workers and allowing for anonymous reporting of the grievance. The procedure will cover the way grievances can be submitted to HR (including anonymously), how they will be logged, processed and resolved, and outlining steps available to appeal any decision. The grievance mechanism will be accessible to the contract employees as well. 

Occupational Health and Safety (OHS): 

As discussed above under PS1, currently the vaccines manufacturing facility at Shameerpet has implemented a certified OHS management system (as per OHSAS 18001 requirements) and the same would be implemented at new vaccine manufacturing facility. The SOPs developed as part of IMS are implemented such as 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. These SOPs are uniformly applied to the company employees and third party workers.

Based on the observations, the facility conducts risk assessment for their operations and undertake required safety measures. Safety induction is provided to employees, workmen, contract workers and visitors. Regular safety trainings are provided to employees as well as contract workers on aspects such as working at height, hot work, first-aid, excavation work etc. Required safety equipment is provided including PPE depending on hazards related to the type of task being performed. PPE usage was noted as being adequate at the visited facilities. Safety signage was noted to be provided, as needed, in English and local language as applicable. Regular health checkups are conducted for both employees and contract workers, based on an analysis of workers’ exposure to workplace hazards. 

The facility has safety committee which reviews safety performance on a regular basis. Safety performance is also reported to the facility management on a monthly basis including on accidents/incidents, near-misses, first-aid cases, EHS training, fire incidents. Apart from project SHE committee there is also contractor safety committee and the committees meet once very month.  The company has not had any major accident involving any employee or any third party worker since last 10 years; those that have occurred relate to minor incidents involving first aid and limited lost time.  

Retrenchment:

The company plans to close its operation at Patancheru (having employee strength of 70) and transfer all the employees to its existing facility at Shameerpet (including contract workers who will be offered the option of relocation). The process of relocation to Shameerpet facility has already started and so far there have been no incidences of any employee opposing the decision. In case any employee is not willing to re-locate, the company will give them the option of transfer to other facilities of the company such as Azamabad or Gaganpahad which are closer to Patancheru (30-40 km away). The company will make best efforts to absorb the existing staff in their current operations and no retrenchment is expected. 

Third Party Workers: 

For construction works, the company hires contractors who engage workers who are in turn supervised by the facility’s relevant management teams (EHS, HR, engineering, production). The company has developed a construction safety plan which is annexed as part of contract document for all new construction works. The construction safety plan includes details on safety organization, safety meetings, first-aid/medical facilities, accident investigation and analysis, fire prevention and protection, emergency response procedures, site traffic plan, security plan, safety practices (scaffolds, excavation, PPE, lockout and tag-out and work permits etc.) which are to be met by the contractor. 

All contract workers in the manufacturing and supporting operations 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. The facility HR departments monitor contractor compliance with various statutory 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 BioE. The wages, working conditions and payments for the contract workers were noted to be aligned with the statutory requirements.

Supply Chain: 

BioE procures various raw materials such as syringes, vials, solvents (methanol and Iso – Propyl Alcohol (IPA), experimental animals etc. The company contracts reputable raw material suppliers and currently has 752 vendors in total.  The company has a dedicated supply chain team which manages these relationships and the suppliers are screened by the quality assurance (QA) team before being contracted. The QA team also conducts regular audits at their facilities. The company follows the ten principles of supply chain sustainability covering aspects such as human rights (support and respect the protection of human rights), labour (uphold the freedom of association, elimination of forced labour, abolition of child labour and elimination of discrimination), environment (initiatives to promote environmental responsibility) and anti-corruption (no extortion and bribery). The principles are however recently framed and the implementation is yet to be enforced. As included in ESAP #4, going forward the company will develop procedures on supply chain management and include specific requirements on EHS including compliance with applicable legal requirements, prevention of child labor, forced labor and ensuring safety of workers in the contracts. 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.

 Resource Efficiency: 

BioE has started monitoring the water consumption at its various facilities and published the data for vaccines division in its sustainability report. The company also has Sewage Treatment Plant (STP) and Effluent Treatment Plant (ETP) for recycle of wastewater at all facilities which is then re-used. 

The company has taken some initiatives for energy efficiency which include: (a) replacement of lamps with energy efficiency LED lighting at all facilities; (b) providing variable frequency drives (VFD) on motors to draw current based on load variation for air handling units (AHU) and chilled water pumps; (c) optimizing air changes per hour and blower revolutions per minute (RPM); (d) installation of temperature controller to cut-off cooling tower fans; (e) recovery and re use of steam condensate; (f) optimization of air conditioning systems; and (g) reuse of condensed steam in the process etc. 

The company also has tie-up with ITC (one of the largest paper manufacturing company in India) for waste paper recycling. Going forward the company has plans to monitor the energy and water consumption and set the efficiency targets on an annual basis.

Air Emissions and Ambient Air Quality: 

The main emissions sources for the facility are the stacks for boilers (based on Furnace Oil) and back-up diesel generators (based on High Speed Diesel). Fume hood has been provided where Volatile Organic Compounds (VOC) handling is involved. 

Ambient air quality and stack emissions are monitored on a monthly basis. Stack emission and ambient air quality monitoring results provided are compliant with the limits specified for the facilities by the SPCB and with the National Ambient Air Quality Standards (NAAQS). 

Water Consumption and Wastewater Discharges: 

The source of water for consumption is predominantly municipal supply. The company has adopted a zero discharge policy for process wastewater and domestic wastewater. Accordingly, Domestic wastewater is treated in STP and recycled for gardening purposes. 

ETP has been provided for treatment of process wastewater comprising of boiler blowdown, floor washing, wash water generated from cleaning of vials, tray washing of animal house (as applicable) and effluent generated from vaccines manufacturing (categorized as live effluent and sent to kill tank first where effluent is heated at 1210C for 30 minutes to kill all bacteria and pathogens and after cooling is then sent to equalization tank of the ETP)). The effluent is provided tertiary treatment (passed through activated carbon filter and sand filter and then passed through reverse osmosis (RO) unit). The permeate from RO unit is reused back in the process as cooling tower makeup and RO reject is sent to Common Effluent Treatment Plant (CETP) through SPCB approved authorized transporter for further treatment. 

Quality of effluent is tested in-house for pH, TDS, BOD and COD on daily basis at various stages (before aeration, after aeration and RO permeate) and also regularly monitored through certified and approved external agencies. Quality of treated effluents (for the tested parameters) was noted to be in compliance with the national standards as well as WBG EHS Guidelines. 

Storm water from clean surfaces is collected and discharged through separate drainage systems. Rainwater harvesting systems have been installed at Shameerpet facility. 

Waste Management: 

The major streams of hazardous waste generated include ETP sludge, used oil, electronic waste from office, expired/discarded chemicals and empty containers. The wastes were noted to be stored in designated and appropriately designed storage areas and sent to government licensed service providers for disposal. The non-hazardous waste streams like plastic, metal and packaging waste are segregated and sold to external agencies for further recycling. 

The facility also generates bio-medical waste which includes dead animals (mice and guinea pigs) from animal house (used for experimental purposes), animal house bedding material and media culture plates. The company has signed an agreement with an authorized and licensed bio-medical waste service provider (GJ Multiclave Pvt. Ltd.) which collects the bio-medical waste stored at designated location within the facility on daily basis and incinerates the waste. Destruction certificate is provided to the facility by the service provider on a monthly basis. BioE as a part of its vendor evaluation conducts audit of its service providers (audit once in 3 years for critical operations such as bio-waste management) and carried out an audit in 2015 for GJ Multiclave – there is an elaborate audit checklist which was followed including check on regulatory compliance, personal hygiene, quality assurance, documentation, complaint handling procedure etc. and evaluated the service provider as satisfactory.  In the next audit scheduled in 2018, the company will also look at efficacy of incinerator and test results of ash generated from the incinerator. 

Hazardous Materials Management: 

Facility at Shameerpet has storage of solvents such as Iso-Propyl Alcohol (IPA) and methanol in a dedicated storage area provided with Lower Explosion Limit (LEL) sensors, spill kits and fume hood for dispensing solvents. There is a SOP on solvents usage that has been developed and is implemented at the facility. Hazardous materials handled are properly assessed and classified for associated hazards and their inventories are known by staff. Material Safety Data Sheets (MSDS) were found to be properly maintained and readily available and appropriate signage was provided. Secondary containment as well as other safety provisions, including spill control and response were provided as needed. Training in chemical handling and emergency situations is provided to both staff and contract workers. 

Company uses thiomersal (containing organic mercury) as preservative in vaccines production however the concentration of thiomersal meets the prescribed limit of WHO & Food and Drug Administration (FDA) for all the vaccines being manufactured. Also the company is looking at options of phasing out thiomersal in the future and has initiated studies to check, and if possible replace, thiomersal with 2-PE in all its vaccine products. The company has already started using mercury free preservatives such as phenol (Typhoid-TT conjugate vaccines & Pneumococcal PS vaccines, etc.) and 2-Phenoxyethanol (in DTaP, Hepatitis-A/B, IPV, etc.)

GHG emissions: 

Primary energy requirement is that of electricity which is supplied from the national grid. Diesel fueled generators are installed on site as backup generators, and are in use in case of power failure. Therefore, GHG emissions are dominated by electricity consumption with a very small contribution from diesel consumption and the facilities of BioE are not expected to produce GHG emissions in exceedance of IFC’s threshold of 25,000 tons per annum of CO2e.

Emergency Preparedness and Response: 

Existing vaccine manufacturing facility of BioE at Shameerpet is located in notified industrial areas surrounded by other similar industries while the new vaccines manufacturing facility although is not located in designated industrial area but abuts the biotech park and does not have any private development. The industrial areas have adequate access roads and are typically located close to the highways/wide roads. As mentioned above, detailed on site emergency plan is developed and the facility conducts drills on a regular basis, in collaboration with the local fire brigade. The fire hydrant system is linked to the water storage network and fire-fighting systems are installed as per the local permit requirements. At Shameerpet, there is a fire station within close vicinity of existing vaccines manufacturing facility.          

Hazardous Materials Management and Safety:  

The company receives the needed raw materials including hazardous chemicals (solvents, FO and HSD) through contracted specialized transport service providers. All solvent tankers are earthed and spark arrestors are provided before unloading. The hazardous materials are stored in dedicated storage areas. The company has in place specific instructions for its transport service providers and drivers in case of  hazardous material transportation which includes: (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 MSDSs and Transport Emergency (TREM) cards for the transportation of hazardous materials and solvents. 

Security Personnel:

Unarmed security personnel are employed 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.

 BioE recognizes corporate social responsibility (CSR) as an essential part of the company identity and therefore supports, through various activities, targeted initiatives for identified stakeholders. Activities include donation to trusts for renovating school building and developing rural roads. As per the requirements of the Companies Act 2013, BioE is required to spend 2% of its average past 3 years’ net profit (after tax) on CSR activity as defined under the CSR Rules, 2014. The company has accordingly set up a CSR Committee at the Board of Directors level and for the year 2015-2016 the total amount spent on CSR activities was of the tune of INR 12.8 million (about USD 200,000).

As described earlier, the company has published its first sustainability report of vaccines division for 2015-2016 (compliant with Global Reporting Initiative G4).