The company is already operational and located in the industrial area of SIIDCUL. As such, no E&S impacts are expected that need to be managed in a manner consistent with the requirements of PS5 (Land Acquisition and Involuntary Resettlement), PS6 (Biodiversity Conservation and Sustainable Management of Living Natural Resources), PS7 (Indigenous Peoples) and PS8 (Cultural Heritage).                                                 

This is a category B project according to IFC’s Policy on Environmental and Social Sustainability (2012) because a limited number of specific E&S impacts may result which can be avoided or mitigated by adhering to generally recognized performance standards and guidelines.

Key E&S risk and issues associated with this project include: (i) the existence and implementation effectiveness of E&S management systems, (ii) assurance of fair, safe and healthy working conditions; (iii) resource efficiency of the operations (energy and water); (iv) life and fire safety management, including emergency preparedness and response plan; (v) management of hazardous chemicals & materials; and (vi) waste management in compliance with local regulatory requirements and World Bank Group (WBG) EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing.

The company collaborates with research institutes and laboratories for clinical trial/testing and does not have any in-house vivarium.                                                 

 An environment, social & governance due diligence (ESGDD) was undertaken by an external consultant on February 18-19, 2021 in accordance with applicable national and local regulations and global standards like IFC Performance Standards, Asian Development Bank’s Safeguard Policy Statement among others for this acquisition.

ZAHL is ISO 9001: 2015 certified and has approvals of World Health Organization Good Manufacturing Practices (WHO GMP). There is an Environment, Health and Safety (EHS) Policy approved by the Managing Director. Procedure for risk management and environmental risk assessment is available, and ZAHL has carried out environmental aspect and impacts identification of all the activities. ZAHL is current on all the applicable E&S related permits and implements the mitigation measures as specified in those permit conditions. The company has implemented documented operational procedures in the form of SOPs, checklists, standard assessment tools and reporting templates. The company also submits quarterly monitoring reports to the State Pollution Control Board (SPCB). Going forward, as part of ESAP#01, Zenex will comply with the corrective actions identified in the ESGDD report dated April 22, 2021 as per the agreed timelines.

Responsibility and authority for managing the E&S issues and risks are defined and communicated. EHS department is responsible for the implementation of environment and occupational health and safety matters and comprises of EHS Head and Deputy Manager EHS. Along with the HR and Admin, the EHS department deals with the aspects related to E&S management and compliance.

The company has an on-site emergency response plan considering all potential emergencies, e.g., fire and explosion, chemical spillage and medical emergencies. The emergency plan includes roles and responsibilities for relevant personnel (as well as their back-up), type of firefighting and first aid arrangements, contact details of the key personnel and external. Periodic mock drills are also conducted and records of one such drills have also been shared. Trainings regarding fire drill, emergency preparedness planning etc. has been provided to the employees.

The company monitors and reports EHS related key performance indicators (KPIs) in compliance with the permit conditions. In order to extend this EHS monitoring program, consistent with the requirements of applicable WBG EHS Guidelines, as per ESAP #02, Zenex will develop the SOP for regular monitoring and reporting of key leading and lagging EHS related KPIs (including but not limited to ambient air, indoor air quality (including for Volatile Organic Compounds (VOCs) and other parameters as mentioned in the WBG EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing). These reports will be submitted to the management team, for review and corrective actions, as needed.                                                 

As of April 2021, ZAHL had 219 employees (60 on-roll and 159 contractual employees) of which only 7 are female. The contract workers are typically involved in housekeeping, facility management services, canteen and security.

ZAHL has adopted HR policies and procedures applicable to its staff, covering recruitment and selection, compensation and benefits, performance evaluation, transfer, training and development, disciplinary action, restriction of forced labor and anti-discriminatory and equal opportunity policy. The policies are consistent with the Indian labor laws and the objectives of IFC PS2.

All employees receive a salary above the minimum national wage. The contractual workers are paid according to the contractual agreements which are as per the industry standards. The attendance is recorded through biometric system. All employees have a written appointment letter from the company explaining the working conditions and terms of employment; and their salaries are paid through the bank accounts.

ZAHL has a zero-tolerance policy for any form of sexual harassment in the workplace. The policy requires that all incidents and allegations of sexual harassment are treated seriously, and prompt investigations are conducted. As a part of ESAP item #03, Zenex will document specific policy on freedom of association and provide training to supervisors and managers and communicate the policy to the employees. Zenex will also update the grievance redressal procedure by making provisions of anonymous reporting and informing the employees about the availability of the procedure during workers and contractor induction session.

Hazard Identification and Risk Assessment (HIRA) has been carried out to identify and assess the occupational health and safety risks associated with all the activities. Additionally, basic Do’s and Don’ts, Material Safety Data Sheets (MSDSs) and safety instructions, self-audit checklists, preventive maintenance checklists, accident/incident investigations and reporting formats have been prepared. ZAHL reports the safety statistics by monitoring the near misses, first aid cases and lost time accidents (LTA); there has been no major reportable accident or incident in the past years.

Impact of COVID-19 Pandemic on Workforce:

There have been no layoffs or staff retrenchment due to COVID -19 and all employees are duly paid with full salary payment through the ongoing pandemic. No significant health impact due to COVID-19 on the workforce has been reported. ZAHL has developed COVID-19 specific SOPs applicable to all employees and contract staff, as per the prevailing guidance from WHO and Government of India. 

  The company monitors the water consumption however has no specific management programs related to water efficiency. The process wastewater is treated in an onsite Effluent Treatment Plant (ETP) prior to discharge into Common Effluent Treatment Plant (CETP) for further treatment and there is no re-use of treated wastewater at the facility.

The company has taken some initiatives for energy efficiency which include: (a) replacement of lamps with energy efficiency LED lighting; (b) providing variable frequency drives (VFD) on motors to draw current based on load variation for air handling units (AHU); (c) optimizing air changes per hour and blower revolutions per minute (RPM); and (d) optimization of air conditioning systems.

There are point source (DG sets and boiler stack) and process air emissions which have been provided with appropriate air pollution control equipment and devices. Stack emissions are monitored through an independent government certified laboratory on quarterly basis and the results are reported as per the permit conditions. Stack emissions were noted to be compliant with the limits specified by the regulatory agencies.

Water is sourced from groundwater and necessary authorization has been obtained from the Central Ground Water Authority for ground water abstraction. Wastewater generated from the process is subject to primary and secondary treatment in onsite ETP before discharging it to CETP of the industrial zone. The quality of treated effluent is monitored quarterly by certified laboratory to assess compliance with standards prescribed in the regulatory permit. Quality of treated effluent (for the tested parameters) from ETP prior to discharge into CETPs was noted to be in compliance with the national standards. The domestic sewage is also discharged to the CETP while the environmental permit conditions prescribe setting-up a dedicated Sewage Treatment Plant.

Management of hazardous and non-hazardous waste is governed by permitting conditions and SOP on hazardous waste has been developed for the facility. There is a valid hazardous waste authorization in place, the company collaborates with research institutes and laboratories for clinical trial/testing and does not have any in-house vivarium. Only regulator approved or authorized hazardous waste recyclers are engaged for waste disposal and are subject to ZAHL’s supplier inspections and audits.

ZAHL uses hazardous chemicals, and their storage, handling and labelling is governed by permitting conditions. Going forward, as included in ESAP item#04, Zenex will develop a SOP on hazardous chemicals and including amongst others: requirement for accurate material data safety sheet (MSDS) provided by the supplier; mandatory checking of labelling of chemicals using global harmonized system (GHS) of classification and labelling of chemicals by manufacturer; storage of chemicals in designated storage shed with ventilation, leak detection systems and sprinkler systems and provision of secondary containment in storage areas to contain the material in case of any spill occurrence.

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. Based on available data on diesel and electricity consumption, the current GHG emissions are estimated to be around total 3265 tons of CO2 equivalents annually.                                                  

 Zenex is located within notified industrial area of SIIDCUL and surrounded by several other industrial units. The industrial estate is located away from the residential communities, with adequate access roads and basic infrastructure available for attending to emergency scenarios.

The company receives required raw materials including hazardous chemicals through contracted specialized transport service providers. All solvents are received in drums and stored in drums, in flameproof area, as applicable. Earthing protection and spark arrestors are provided before unloading with automated earth interlocking system for tankers received for furnace oil and diesel. The hazardous materials are stored in dedicated storage areas that are designed, constructed and maintained as per permitting requirements. The company enforces specific instructions for its transport service providers and drivers in case of hazardous material transportation such as maintaining MSDSs and Transport Emergency (TREM) cards for the transportation of hazardous materials and solvents. Going forward as included in ESAP item#05, EHS department of Zenex will develop SOP to undertake bi-annual training for the transport fleet operators on risks associated with hazardous chemicals handling and transport.  Warehouse, supply chain related checklists are also monitored and administered.

Unarmed security personnel have been deployed through local security vendors authorized by government. The company briefs security personnel about policies on child labor and provides training on basic safety, first-aid, fire safety and emergency response.