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Kapil Khandelwal Pharma Erm And Green April 2009

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Pharma Environment Risk Management (ERM) and Green Initiatives in India

Pharma Environment Risk Management (ERM) and Green Initiatives in India


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  • 1. S P E CI AL F E ATU RE Environment waste management Gaining momentum Pharmaceutical companies world-over show resistance when the topic of environment waste management comes up. This is mostly due to the unfamiliarity of the terrain and also because of the inability to demark an appropriate section, which can assume responsibility towards environment waste management. However, the good news is that this perspective is slowly and steadily changing and Indian companies are now matching pace with the rest of the world. Read on as Jayata Sharma takes an account of how companies today are consciously working towards maintaining a safe level of waste. h azardous waste is any waste leads to huge quantities of wastes. The E- which by reason of any of its factor (defined as kg waste generated per physical, chemical, reactive, kg of product) of the pharma industry is toxic, flammable, explosive or in the range of 25 to more than 100. This corrosive characteristics cause danger means that 1 kg pharmaceutical product to health or environment, whether alone produced generates 25 kg to more than or when in contact with other wastes or 100 kg of waste. Today, across the world, substances. All types of industries face the more than 1 billion kg drugs are being issue of waste management, be it chemicals, manufactured. This gives us an indication of manufacturing units, hospitals or the the magnitude of waste the pharmaceutical pharma sector. industry generates,” informs Nitesh Mehta, Pharma companies usually have an founder & director, Newreka Green SynthTM environmental conservation division, Technologies Pvt Ltd. which is responsible for the treatment With regard to the various certifications, & management of gaseous emissions, Kapil Khandelwal, founder and director, wastewater, and other types of waste Disease Management Association of India generated at manufacturing plants. (DMAI) and leading thought leader in the Yet, waste management takes a pharma industry says, “If we see ISO 14000 back seat, much after process efficiency, certification as a barometer and metrics yields, manufacturing costs, utilities, and for environment risk assessment (ERA) effluents generated. “Since margins are or environment risk management (ERM) so high, the pharma industry can afford adoption in the Indian pharma industry, we low process efficiencies, but this in turn would see almost 100 per cent compliance 56 Modern Pharmaceuticals April 2009
  • 2. SPECIAL FEATU R E in the companies that are operating Nitesh Mehta in the export sector. Today, several founder & director, Newreka Green SynthTM Technologies Pvt Ltd Indian pharma companies are contributing to the best practices of the global pharma community. Green Chemistry-based processes or technologies However, these need to be viewed improve process efficiencies and reduce the E-factor in terms of local as well as regional for the industry. These processes or technologies regulations that govern the industry. are economically & environmentally much As the Indian pharma industry is getting more and more integrated more competitive than conventional processes/ with the global mainstream phama technologies being used by them currently. industry and large acquisitions like Ranbaxy’s take place, ‘ERM and Green’ is an important boardroom growth linked to green initiatives and third, it seriously damages the discussion and measure of value including ERM quality of our water bodies & the air for pharma companies,” . According v Employee satisfaction ratings (aeration & incineration both releases to industry experts, some of the v Financial analyst ratings substantial quantities of CO2 into key management issues that are v Declining number of green-related the atmosphere). prevailing include: lawsuits/legal actions Mehta feels that the right concept v Cost reductions from environmental “Regulations have already been involves looking at each effluent waste management and recycling established in the EU and US with stream as separate. Because once efforts ERA for pharmaceuticals. In fact, in all the effluent streams are mixed, v Documented/accepted compliance Japan, a group that is closely related there is nothing much that can be with regulatory requirements to the Ministry of Health, Labour and done about it except what is being v Customer satisfaction/brand Welfare has begun to study similar done currently, ie, treat, dispose perception ratings as a result regulations. The EU and the US or incinerate. of this have adopted these regulations, “For companies to carry out ERA v Organisation-wide carbon footprint and very soon, the ERA guidelines for pharmaceuticals, it is essential to reduction will also be established in Japan,” make a inter-departmental project v Certifications and endorsements says Takayuki Anzai, president, team, which involves related sections received from environmental groups RCC Japan Co Ltd, Japan. of production, product management v Product or service revenue and assurance, environmental Managing waste conservation, pharmaceutical affairs, Case study Most industry experts do not crisis management, safety, outsourcing Riker Laboratories, California believe in the concept of waste and drug formulation. Prior to forming Riker Laboratories was coating management, which conventionally this project team, it is important medicine tablets using several means, collecting the waste streams that the ultimate decision-making organic solvents as carriers. A of all the products manufactured in board of the company decides to water-based solvent was developed the plant, taking it to the effluent establish the project and thereafter to replace the organic solvent treatment plant, carrying out primary make an appropriation for the same. and different spray application & secondary treatment (either in Next, to lead the project to the equipment was installed to handle their own premises or some common contact section, a section granted the new solvents. These changes liquid effluent treatment plant) and budgetary and decision-making eliminated organic solvent losses to then finally disposing off the treated authority for ERA is required. Then, the the atmosphere. effluents into the sea or river required information for the ERA for Economics: or incinerate. pharmaceuticals must be collected 1. Less than 12 months to recover This has three impacts. One, the at the contact section and must be investment raw materials or finished product efficiently sent to a contract research 2. $ 15,000 annual savings in present in the waste streams organisation (CRO). Additionally, it solvent costs is lost; second, the treatment, proves easy to manage the budget 3. 24 tonne/yr reduction in air disposal & incineration of waste for outsourcing. All in all, this kind of pollution adds significantly to the cost of model gets an advantage of reduced manufacturing of the product; time for ERA,” says Anzai. April 2009 Modern Pharmaceuticals 57
  • 3. S P E CI AL F E ATU RE Kapil Khandelwal The challenges founder and director, Disease Management Association of India (DMAI) The key challenge that the industry faces in implementation of waste management practices As the Indian pharma industry is getting more and is that of limited options (treat it more integrated with the global mainstream phama or dilute it & send it to common industry and large acquisitions like Ranbaxy’s take effluent treatment plants, dispose off place, ‘ERM and Green’ is an important boardroom through third party or incinerate it). discussion and a measure of value for the pharma “Unfortunately, each of these options companies. is a cost centre. As the environmental norms are becoming more & more stringent, these challenges are increasing,” says Mehta. Need of the hour recycling used/waste byproducts in Green Chemistry offers a First and foremost, the pharma the pharma industry. The industry solution to this problem through industry needs to find and apply the must work towards not only meeting a completely new approach. right tools for integrated solutions. legal requirements, but also going “Permitting processes can also For instance, eco-efficiency audits like ‘beyond compliance’ to ensure better make the approval of integrated better management practices, cleaner management of waste. innovative solutions lengthier, more production for process optimisation, Other important steps are cumbersome, and less certain than performance verification with setting environmental policy for conventional approaches,” says an environmentally sound technologies within the context of economic industry expert. and responsible care with and business principles, focussing Permitting and compliance environmental management on long-term outcomes, making systems often discourage systems can be applied. sufficient use of the full range of stakeholders from taking risks The industry must pritoritise policy tools (especially market-based necessary to develop innovative, requirements, which is the ultimate instruments), avoiding inconsistent, integrated, environmental solutions. weapon to end the menace of complex, and sometimes conflicting Also, regulatory and statutory waste. One good option would be to compliance and enforcement requirements can limit the have a ‘technology prescription’ for regimes, improving both opportunity to introduce flexibility transparency as well as the into implementing policies, thus ability to drive & measure progress inhibiting efforts to encourage through credible information and innovative environmental solutions. reporting & recognising the limits The most challenging fact is that of what leaders in sustainability many existing environmental can do without a supportive policy standards were actually developed framework. These steps will enable around a particular technology. broad-based action by the industry And, even though these standards and consumers to improve global are performance-based, they tend environmental performance, to ‘lock in’ the technology used to level the playing field, set long-term demonstrate achievability! approaches to achieve outcomes, have more predictability on Role of government priorities & outcomes, give The government has already incentives to drive & reward started taking initiatives like forming corporate leadership and ‘Green Chemistry Task Force’ under strong domestic approaches to the Department of Science & international commitments. Technology. Green Chemistry Task The time has come when Force promotes all aspects of Green the pharma industry must sit Chemistry like research, training back and think about whether and teaching. It offers funds for to anticipate and prevent or open-ended collaborative research react and treat. between industry & research 58 Modern Pharmaceuticals April 2009
  • 4. SPECIAL FEATU R E institutes. It is making attempts to Green Chemistry & Engineering in the of waste and also reduce the impact develop Green Chemistry curriculums pharma industry globally. of the waste on the environment. and also organising workshops for “Given that India is emerging as However, since the pharma training in Green Chemistry. one of the key manufacturing hubs industry is competitive, they are Industry leaders feel that the for the world, our effluent volumes constantly under pressure to stay government could also look at and environmental challenges are ahead. The pharma industry is empowering companies that are going to be much higher as compared realising that the competition taking initiatives to do R&D, develop, to the challenges of the US. Against will always remain and that the scale-up or commercialise Green that background, the initiatives that environmental norms are only going Chemistry-based technologies, we all are taking are insufficient,” to move in the direction of being facilitate companies intending to observes Mehta. stringent. So, one of the possibilities follow Green Chemistry and provide that many pharma companies have various incentives to companies with Research & development already started implementing is environmentally benign processes. Most pharma companies have to continue their R&D teams focus their own internal R&D teams on the discovery, development & A Western comparison working on optimising processes, launch of drugs and to collaborate The West, especially the US has reducing solvent & other raw material or outsource research, on Green realised the impact of environmental consumptions, changing route of Chemistry or developing technologies damages that industries are causing. synthesis, etc, to reduce the quantity to address their pollution concerns “The critical mass (the government itself, the top government agencies, Flow of ERA for pharma and a project model for pharma companies top bureaucrats & critical mass of chemists & chemical engineers) have Establishment of a project, decision to Main points realised that the way we conduct make an appropriation for the project (1) In accordance with the decision made at our chemical reactions in its current (Decision at the board of directors or executive officers) the superior board, one project member state is not sustainable & there is a participates form each section. (2) A section that is granted decision- need to design & develop products & Summarisation of information required at the early making authority for the outsourcing of processes which are environmentally stage towards accrediation by the EMEA and FDA the assessment assumes the role of the benign and sustainable. And the need contact section. (3) The contact section collects information is urgent,” insists Mehta. Selection of a CRO and the start of assessment Feedback required for risk assessment from each Having realised this, the initiatives from the CRO section. being taken in the West to sensitise, (4) A CRO is selected and confirmed at a project meeting. promote & propagate Green Completion of the assessment, preparation (5) The contact section exchanges information Chemistry & Green Engineering is of application materials with the CRO, and sends the information far ahead of that in India. Prof Paul form the CRO to project members. Anastas (also known as the father (6) The contact section or other related Notification to the EMEA or notification sections monitor examinations if necessary. of Green Chemistry) and Prof John (7) The CRO prepares application materials to the FDA after supplementing data Warner are leaders in the US who (if the CRO can prepare). are playing key role in driving these initiatives. The American Chemical Society - Green Chemistry Institute Environmental Product management conservation and assurance (ACS-GCI) has also been a forerunner in sensitising & promoting Green Crisis Chemistry in the world. Along with Production management these initiatives, ACS-GCI has also Contact Section (Project leading) formed ‘Pharmaceutical Roundtable’ which is a body with top US pharma Taken on by a section that is granted budgetary authority and companies (including Pfizer, Glaxo, decision-making authority Merck, Eli Lilly, Johnson & Johnson, Astra Zeneca, Schering Pluogh, etc) Drug formulation Safety as its members & ACS-GCI as the Pharmaceutical coordinator. The mission of this body Outsourcing affairs is to catalyse the implementation of Source: RCC Japan Co Ltd April 2009 Modern Pharmaceuticals 59
  • 5. S P E CI AL F E ATU RE like ‘nano catalysts’ for traditional Takayuki Anzai chemistries with a special focus on president, RCC Japan Co Ltd, Japan the use of iron & iron-based catalysts. This is in the direction of shifting industries from using precious metal Regulations have already been established catalysts (most of which are expensive in the EU and US ERA for pharmaceuticals. In and hazardous when ultimately fact, in Japan, a group that is closely related to disposed off after use) to the Ministry of Health, Labour and Welfare has environmentally sustainable begun to study similar regulations. materials like iron. Companies providing solutions for waste management are now revisiting those chemistries/processes, from research institutes, academic becomes all the more essential to to create new knowledge by carrying institutions, government laboratories endure commitments towards out a lot of experiments. They or private companies, who specialise the people. customise that new knowledge for in this field. It is through the all round the industry customer’s molecule/ support of the various stakeholders product to develop an alternative Future prospects of the industry that this issue can process, scale-up the process and Experts believe that the corporate be resolved. Some environmental then commercialise the new process. commitment is key to tackle the protection companies are already “These Green Chemistry-based issue of pharma wastage. The helping pharma companies processes or technologies improve industry must adopt responsible make a start. These companies are process efficiencies and reduce guiding principles, as this is one developing new compounds with the E-factor for the industry. These sector that creates products and less wastage footprint. processes or technologies are services that make life better for For example, an Indian company economically & environmentally people around the world. Hence, it is on its way to explore new catalysts much more competitive than the conventional processes/technologies being used by them currently,” says Mehta. “With ‘green’ being the buzzword and a huge boardroom agenda in the industry, including pharma, one of the areas that is missing is the alignment of such a programme into corporate performance management. We will continue to see this implemented aggressively to ensure that companies have a concrete plan to reduce year-on-year reduction on environment wastage and green initiatives. The phrase ‘think globally, act locally’, can also be applied to the corporate performance management programme to environmental wastage and green initiatives in pharma companies,” avers Khandelwal. The overall metrics for wastage reduction and green must be clear and the entire company must be aligned, but ‘locally’ the departments and individual areas must be where the action should be. 60 Modern Pharmaceuticals April 2009