Environmental and Social Impact Assessment (ESIA): Considering that the JPL’s API manufacturing facility is covered under category of bulk drugs and intermediates excluding drug formulations, as defined in the Indian environment impact assessment rules, the company will be required to conduct Environmental Impact Assessment (EIA) studies for any major expansion at the existing API facility in Nanjangud or for any new API facilities. The parent company JLS has completed such EIA studies as per applicable legal requirements for a proposed capacity expansion project in Nanjangud (October 2013).
Additionally, any proposed CAPEX is evaluated through the corporate’s multi-stage project evaluation process (stage gate process). The Chief Sustainability Officer (CSO) is part of the steering committee of this process and provides inputs on any risks associated with proposed CAPEX projects as well as supports in identifying potential solutions. Any additional EHS studies as required (e.g. Hazard Operability (HAZOP), Failure Mode and Effects Analyses (FMEA) and effluent treatment feasibility of a potential effluent stream) are completed prior to approval of proposed CAPEX.
Going forward the company will include IFC Performance Standards and World Bank Group (WBG) EHS Guidelines (i.e., General, Pharmaceuticals and Biotechnology Manufacturing, Waste Management Facilities) as additional requirements while evaluating any proposed CAPEX. Also, any ESIA studies conducted by the company will meet IFC Performance Standard (PS) 1 requirements. As part of the ESAP, JPL will therefore develop a standard procedure and terms of reference (ToR) for any such future ESIA and E&S due diligence (for prospective acquisitions) studies meeting IFC PS1 requirement, and specifically integrating social impacts into the risks and impacts identification process to further align with the Performance Standards. The ESIA procedure will spell out commitments in terms of company’s minimum requirements for primary and secondary data collection and analysis, risk and impact identification and assessment, mitigation, development of project-specific environmental and social management plans, public consultation, disclosure, and stakeholder engagement.
Policy and Management Systems: The parent company JLS has the documented Corporate Sustainability Mission as well as corporate policies on EHS, Climate Change Mitigation and Green Supply Chain. The policies were noted to be displayed at the visited facilities. The same policy and management systems will be applicable to JGL and JPL after ratification by the Board of Directors of JPL and transfer of the production facilities. JPL’s Nanjangud facility has Quality, Environment, Occupational Health & Safety (OHS) management system certifications compliant with ISO 9001, ISO 14001, and OHSAS 18001 requirements respectively. Both pharmaceuticals facilities in India – Nanjangud and Roorkee - are approved as per Good Manufacturing Practices (
GMP) requirements of various countries including United States Food and Drug Administration (USFDA), United Kingdom (UK)’s Medicines and Healthcare Products Registry Agency (MHRA-UK), Brazilian Health Surveillance Agency (ANVISA–Brazil), Therapeutic Goods Administration, Australia (TGA-Australia), Pharmaceuticals and Medical Devices Agency, Japan (PMDA-Japan) among others. The North American pharmaceuticals facilities are also approved by the US FDA. At the facilities visited during the appraisal, the systems were noted to be adequately implemented. The relevant management system certifications will be transferred to JGL/JPL after surveillance audits by the relevant certification bodies.
Organization: Consistent with the organization of the parent company, JPL will have a Board Level Committee on sustainability comprising of independent and executive directors which will oversee the company’s performance on environment, economic and social factors and provides recommendations. At the corporate level, the E&S management responsibility will be with the CSO who will report to the Executive Director – Ops (Operations), Sustainability and BE (Business Excellence). The corporate sustainability team (CST) under the CSO will be responsible for design and implementation of a governance structure for guiding facilities in implementation of EHS, sustainability and corporate social responsibility (CSR) programs and monitoring performance for all JPL facilities globally. Depending on the risk, the CST will conduct regular risk assessments and compliance audits throughout the year across facilities.
The EHS teams at each of the facilities will comprise of EHS Managers, safety officers and other staff who are responsible for implementing facility specific EHS systems, sustainability projects and CSR activities and reporting back to corporate as part of the reviews and assessments.
The company recognizes that a consistent implementation of corporate management policies and procedures throughout its teams and facilities is a key factor that needs to be ensured in view of the transfer of pharmaceutical assets from JLS to JGL/JPL. JLS has confirmed that there will be a corporate sustainability management team with the necessary authority to implement the corporate sustainability management systems and practices and oversight role throughout the new organization in JPL. JPL’s EHS Head and sustainability team will report to the CSO to align on sustainability management and standardize procedures as per IFC PS requirements. The CST will also bring in functional expertise at JPL level.
Monitoring and Reporting: Consistent with the parent company, JPL will have a corporate standard operating procedure (SOP) on EHS and Sustainability Review and Governance mechanism. As part of the SOP, the safety performance of each facility will be reviewed every month at the facility level by the unit head with all senior and middle management group and reported to CST. Fu
rther JPL will have a corporate statutory compliance monitoring software where all facilities (as well as company’s departments) will report their statutory compliance status once in a quarter with relevant evidence of compliance. Statutory compliance on EHS will be a part of this software checklist. Summary of the compliance status will be presented to the board and reported/identified non-compliances will be followed up for corrective actions. JPL’s company secretary will be responsible for review of the evidences as well as facility audits for statutory compliance.
The CST will conducts sustainability and EHS audits at each of the facilities at least once a year, including cross functional EHS audits where EHS team members from different facilities will audit another facility. Any non-compliances/issues reported in these audits will be followed up regularly to ensure corrective actions.
A performance review is undertaken every quarter at the corporate level by the Apex Sustainability Committee chaired by Executive Director (Ops, Sustainability & BE) and including the CSO, facility heads and Head – Manufacturing. The committee reviews progress on sustainability targets, conducts gap assessment and takes essential decisions to improve performance. The Board Committee on sustainability reviews the sustainability performance on a half yearly basis.
In terms of external audit, third party certification bodies audit the facilities periodically as part of the certification/surveillance protocols. As needed, EHS processes are also reviewed in cases mandated by the internal audit committee and as part of the enterprise risk management (ERM) audits, both conducted by external consultants.
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 CTO (Consent to Operate) and stipulated by respective State Pollution Control Boards which also vary within facilities. Current monitoring practices have scope for improvements. As part of the ESAP, JPL will develop a corporate environmental 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, incinerators, 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 Guidelin
es, EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing, and Waste Management Facilities. Regular monitoring will be conducted for these parameters and corrective actions taken as necessary.
As discussed under PS3, the production units have various storage facilities for chemicals and waste, including underground storage tanks for solvents at Nanjangud. In order to identify and timely mitigate risks of eventual contamination events, the corporate environmental monitoring procedure will specify the need for groundwater monitoring at the production facilities through installation of dedicated monitoring wells.
As regards external reporting, since 2002-03, the parent company JLS has been reporting its economic, environmental and social performance through Sustainability Reports, publicly available at
http://www.jubl.com/cpage.aspx?mpgid=19&pgid=27. The reports have been receiving A+ Application Level Check statement since 2007 by GRI (Global Reporting Initiative). Third party auditors provide independent assurance statement on JLS Sustainability Report covering corporate’s sustainability performance during the financial year. Going forward, JPL data will be publicly disclosed as part of JLS'' Sustainability Reports.
Emergency Preparedness and Response: In accordance with local requirements, JPL will provide and maintain 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, sprinklers in API and product storage areas (at Roorkee only) as well as fire tenders (at Nanjangud). Smoke detectors, gas detectors, water deluge and alarm systems were observed to be installed at the facilities visited by IFC. 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 production units visited by IFC.
On-site emergency response plans (OSEPs) have been prepared for the operating facilities, including Nanjangud and Roorkee, covering various types of emergencies. Roorkee and Nanjangud facilities do not fall under the national requirements for Major Accident Hazards (MAH), hence offsite emergency plans are not mandated. JPL is required and committed to complete quantitative risk assessment (QRA) studies for its Nanjangud units according good international industry practice. As needed, JPL will complement the assessment carried out as part of the EIA for the proposed capacity expansion project to ensure that all units and solvent bulk storages at Nanjangud are assessed by a QRA and the actions identified in the EIA are implemented, including the development of a Disaster Management Plan, with bot
h onsite and off-site emergency preparedness and response plans.
The JPL’s facilities 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. Regular emergency response drills, including evacuation drills and fire drills, are conducted for different emergencies, as required by the OSEPs.