Waste management in the pharmaceutical industry : an evaluation report of Dr Reddy's Laboratories

摘要

The pharmaceutical industry must worry about managing pharmaceutical waste as it poses a health risk to human beings and its presence in the environment can also contribute to loss of biodiversity. Ngwuluka, Ochekpe, and Odumosu (2011: 11259) state that “Pharmaceuticals, though used to treat and manage diseases, are poisons, which justify the growing concerns about their presence in the environment.” Various forms of pharmaceutical waste exist, Ngwuluka et al. (2011) identified the following forms of pharmaceutical waste: Expired dosage forms, non-reworkable formulations, spilled pharmaceuticals, rejected active pharmaceutical ingredients, expired active pharmaceutical ingredients, and wastewater resulting from the water used for process operations during manufacturing and could come from the water used to clean equipment, pipes and floors, and would contain amongst other materials, chemicals and active pharmaceutical ingredients (APIs). A review on the pharmaceutical industry and the progress they have made in environmental management by generating health, safety and environmental programs, preventing pollution, waste minimization, recycling and reusing materials, investing in projects and facilities to ensure environmental sustainability have been established (Berry & Rondinelli, 2000). Dr. Reddy’s Laboratories is an Indian based pharmaceutical company which imports, markets and sells medicines in South Africa. Dr. Reddy’s has plans to set up a manufacturing plant in South Africa. The purpose of this study is to research waste management practices at Dr. Reddy’s plant in India and to draw parallels between India’s and South Africa’s waste legislation. This is to enable Dr. Reddy’s to review all aspects of its waste management systems, in order to revise where necessary and to improve the overall achievement of its waste management objectives in order to become a more sustainable organisation and to meet South African Waste legislation before setting up a plant in South Africa. 3 ii. Objective of the Evaluation Report The purpose of this research is to evaluate and analyse the development and implementation of a waste management system in a pharmaceutical company, specifically Dr. Reddy’s Laboratories. This is primarily to enable the company to review and analyse all aspects of waste management pertaining to pharmaceutical manufacturing and to revise or improve where necessary to ensure adherence to waste regulations as outlined by government. The following research goals have been also been identified:  To identify and describe waste management practices at Dr. Reddy’s Laboratories, on the inherent assumption by the researcher that the company has a successful waste management strategy that would need to be reviewed to identify areas of improvement before expanding manufacturing facilities into South Africa.  To evaluate, assess and compare similarities and/or differences between the identified South African Legislation for Waste Management with those identified during research conducted at Dr. Reddy’s iii. Importance of the Research Conducted Waste Management is important in that it not only removes from the environment, substances that can be harmful to humans and animals but it also enables an organisation to be more sustainable. According to Seadon (2010: i) “Integrated waste management is considered from a systems’ approach, with a particular emphasis on advancing sustainability”. The study will provide guidance to senior management, shop floor managers and employees who work in Dr. Reddy’s manufacturing plants as well as overall employees at Dr. Reddy’s on how to successfully implement a Waste Management programme to enhance sustainability at the organisation and realise the benefits to the organisation of being more sustainable. Weybrecht (2010) identified the following benefits that companies could gain by adopting sustainable waste management practices: reduced costs, resource preservation, keeping up with legislation, enhanced reputation, business differentiation from competitors, and attraction and retention of quality employees, and customer need satisfaction amongst many other benefits. This research needs to address the gap in analysing waste management practices (with more emphasis on waste treatment, waste minimisation, re-use, recycling and disposal), and implementation and understanding of waste management in the pharmaceutical industry as prior research was done mostly in other chemical industries and not to a large scale in the pharmaceutical industry. South African Waste Legislation, Indian Waste Legislation (as Dr. Reddy’s is based in India), as well as International Pharmaceutical Waste Management Guidelines, and International Pharmaceutical Good Manufacturing Practices provide a framework and benchmark of leading pharmaceutical waste management practices that can guide Dr. Reddy’s Laboratories’ leadership into integrating their waste management practices into their plans of setting up a manufacturing plant in South Africa. 5. Research Methodology This is evaluation research in the form of a case study and the data collection method employed is the conduction of a survey through questionnaires. The evaluation research also involves a document analysis of the organisation’s 2011 and 2012 annual reports, Dr. Reddy’s 2010 Sustainability Report as well as literature compiled by the organisation’s Corporate Communications Division. The research would also include review of existing literature on waste management. v. Structure of Dissertation This dissertation consists of three sections. Section 1: The Evaluation Report The section introduces the research area, provides the objectives of the research, provides contextual background information and describes the rationale for conducting the research. This section further describes Dr. Reddy’s waste management practice as outlined in relevant company documentation; it is also intended to highlight the specific waste management processes that were followed in the formulation and implementation of the waste management strategy. This section further describes the sample and presents the results of the survey, where the results are collated and reviewed in the context of the criteria set in the South African Waste Legislation, Indian Waste Legislation, as well as in International Pharmaceutical Waste Management Guidelines, and International Pharmaceutical Good Manufacturing Practices. The overall findings of this case study suggest that although management at Dr. Reddy’s are satisfied with waste management practices and results achieved at it manufacturing plant, there is however dissatisfaction amongst employees who believe the organisation has not successfully disseminated information and sufficiently trained them on waste management policies, processes and practices. There is therefore a desire amongst employees to be trained and to see the company improve on its waste management processes, this desire is a very important attribute as it indicates that employees at Dr. Reddy understand and are committed to the importance of waste management. Future research should be conducted to measure the legal impact of non-compliance to legislation governing waste management in the pharmaceutical company. Section 2: Literature Review The objective of the literature review is to provide a critical assessment and evaluation of previous research in the field of waste management in general as prior research was done mostly in other industries and not to a large scale in the pharmaceutical industry. The literature review evaluates the key elements of an effective waste management strategy implementation and is followed by a review of literature pertaining to the description of Pharmaceutical waste. Section 3: Research Methodology This section presents a description of how the work in this research was conducted. It presents the research process followed in compiling this case study, represented by the aims and objectives, research methodology and design, data collection techniques and data analysis.