Kapil Khandelwal EquNev Capital www.equnev.com

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
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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
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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