Questionnaire: • How does environment wastage take place in the pharma sector?

The driving force for the pharma sector is “Time”. Once a new molecule is identified as a potential drug, the patent is filed & the clinical trials on the molecule start, while the drug is under development, the chemists developing the molecule are under tremendous pressure to quickly develop a commercial process, file the DMF & launch the drug in the market. All throughout the process, “time” is the only critical parameter. Process efficiency, yields, manufacturing costs, utilities, and effluents generated and all other parameters become secondary. Since the margins are so high, pharma industry can afford very low process efficiencies. Low process efficiencies lead to huge quantities of wastes. The E-Factor (defined as kgs waste generated per kg of product) of the pharmaceutical industry is in the range of 25 to 100 +. This means that 1 kg pharmaceutical product produced generates 25 kgs to 100+ kgs of waste. Today, across the world, more than 1 billion kgs of drugs are being manufactured. This gives us an indication of the magnitude waste the pharmaceutical industry generates.

• What is the status of environmental risk assessment/management in the Indian pharma

sector? Kindly provide with some statistics here.

Most of the pharma companies do this internally & don’t share this with us.

• What does your company do to tackle this issue?

Newreka is a knowledge based platform which innovates, develops, scales up and commercializes “GREEN CHEMISTRY SOLUTIONS” for the chemical industry especially pharmaceuticals, specialty & fine chemicals, agro chemicals, dyes & pigments industry.

5 – 6 decades back while chemical industry was evolving and chemists were working on developing various chemical processes, to manufacture various chemicals, which would ultimately go for manufacturing products needed by our society, the volumes were quite low. The only considerations used to develop these processes were “Quality” & “Cost”. Since the volumes of these chemicals that point were low, the “Environmental” aspect or impact was not considered since it wasn’t significant. Those chemists never knew that human population in the following decades will grow exponentially and the requirements of these chemicals will increase drastically.

As the population grew & consumerism grew, the volumes in which these chemicals were required went up & manufacturers scaled-up the same processes. Along with the volumes of finished products, the effluents generated also multiplied and we had no idea how to deal with those huge volumes of effluents. So over a period of time, instead of going back to chemistry & reinventing those processes with additional dimension of “Environment” (without compromising on Quality & Cost), we went in the direction of devising various treatment and disposal methods.

At Newreka, what we are doing is revisiting those chemistries/processes, create new knowledge by doing a lot of experiments, and customize that new knowledge for our customer’s molecule/product to develop an alternative process, scale-up the process and then commercialize the new process. In short we innovate, develop, scale-up and commercialize Green Chemistry Solutions for our customers.

These Green Chemistry based processes or technologies improve process efficiencies and reduce the E-Factor for our customers. These processes or technologies are economically & environmentally much more competitive that the conventional processes/technologies being used by them currently.

• Kindly elaborate on the services you implement/provide for the management of

pharma waste? The monetary issues involved?

We actually don’t believe in the concept of waste management, which conventionally means, collecting all the waste streams of all the products manufactured in the plant, take to the effluent treatment plant, do primary & secondary treatment (either in their own premises or some common liquid effluent treatment plant) and then finally dispose the treated effluents in to the sea or river or incinerate. This has three impacts. One, the raw materials or finished product present in the waste streams is lost; secondly, the treatment, disposal & incineration of waste adds significantly to the cost of manufacturing of the product; and thirdly, it seriously damages the quality of our water bodies & air (aeration & incineration both releases substantial quantities of CO2 i.e. greenhouse gas to the atmosphere). Our concept involves looking at each effluent stream as separate. Once all the effluent streams are mixed, there is nothing much that can be done about it except what’s being done currently i.e. treat, dispose or incinerate. Note: The services we offer is mentioned in previous answer.

• Which challenges are faced in implementation of waste management practices?

The key challenge that the industry faces in implementation of waste management practices is they have very limited options (treat it or dilute it & send it to common effluent treatment plants, dispose it through third party or incinerate it). Unfortunately,

each of these options is a cost center. As the environmental norms are becoming more & more stringent, these challenges are increasing. Green Chemistry offers a solution to this problem through a completely new approach. The challenges involved in implementing these solutions are; firstly, since it’s a new field, the tool box (the processes & technologies in the domain of Green Chemistry that are proven) is limited. Secondly, since the solutions are not readymade an investment is required to develop such solutions & there is a certain level of risk involved in doing that because it’s been done for the first time. Given the current scenario of market, when business is down, margins are low & competition is tough, industry obviously is in a dilemma whether to invest resources and take the risk of new development at this time.

• Kindly shed some light on the environmental legislations and regulations in India

regarding pharma wastage.

We don’t have much idea about the legislations since we aren’t directly involved in these matters or don’t interact directly with various pollution control bodies. However, we know that these legislations are becoming stringent with time.

• Which research activities are taking place in this sector?

Most pharma companies have their own internal R&D teams working on optimizing processes, reducing solvent & other raw material consumptions, changing route of synthesis, etc to reduce the quantity of waste and also reduce the impact of the waste on the environment. However, since the pharma industry is a very competitive industry, they are constantly under pressure to launch new products. Hence, most of the companies land up investing huge resources in discovery of potential drugs, clinical trials, development & launch of new drugs and a very limited amount of their resources is invested in the direction of research on dealing with environment challenges involved in manufacturing of these drugs. Given the nature of the industry where developments happen real fast & competition is high, this strategy of investing resources is valid. The pharma industry is realizing that the competition will always remain & they are also realizing that the environmental norms are only going to move in the direction of being stringent. So one of the possibilities which many pharma companies have already started implementing to deal with this situation, is to continue their R&D teams focus on discovery, development & launch of drugs and to collaborate or outsource research, on Green Chemistry or developing technologies to address their pollution concerns, from research institutes, academic institutions, government laboratories or private companies, who specialize in this field.

• What is the role of government in this?

The government has already started taking initiatives like forming “Green Chemistry Task Force” under Department of Science & Technology. Green Chemistry Task Force promotes all aspects of Green Chemistry like research, training, and teaching. They offer funds for open ended collaborative research between industry & research institutes, they are making attempts to develop green chemistry curriculums and also organizing workshops for training in green chemistry. The government can create a 5 Year Plan or kind of a road map for creating, sustaining & forwarding Green Conscience in India. What the government can do is empower companies which are taking initiatives to do R&D, develop, scale-up or commercialize Green Chemistry based technologies, facilitate companies intending to follow Green Chemistry, provide various incentives to companies with environmentally benign processes, etc. What the government can also do is develop & implement new curriculum which imbibes & inculcates Green Conscience in our children right from childhood so that the next generation, in their basic approach, are responsible and care for their own environment. Government can also empower & support colleges & research institutes to create Green Chemistry Departments & include Green Chemistry & Green Engineering as a fundamental subject in B.Sc., M.Sc., B.Tech & M.Tech curriculums.

• Kindly elaborate on the state-wise contribution to pharma waste management in India.

(E.g. which states contribute most waste and which are efficient)

We don’t have such data. • How is the scenario in the West as compared to India in this section? Are we at par

with them? If no, what is lacking and how can we take care of it? The west, especially US has realized the impact of environmental damages that our industries are causing & is present that if this is the way we continue to create waste & this is the way we continue to treat & dispose waste, we are headed for a disaster. The critical mass (the government itself, the top government agencies, top bureaucrats & critical mass of chemists & chemical engineers) have realized that the way we conduct our chemical reactions (i.e. our chemistry & chemical engineering) in its current state is not sustainable & there is a need to design & develop products & processes which are environmentally benign and sustainable. And the need is URGENT. Having realized this, the initiatives being taken in the west to sensitize, promote & propagate Green Chemistry & Green Engineering is far ahead of that in India. Prof. Paul Anastas (also known as the father of green chemistry) and Prof. John Warner are leaders in the US who are playing lead role in driving these initiatives. The American Chemical Society - Green Chemistry Institute (ACS-GCI) has also been playing a lead in sensitizing & promoting green chemistry in the world. Inside these initiatives, ACS-

GCI has also formed “Pharmaceutical Roundtable” which is a body with top US pharma companies (including Pfizer, Glaxo, Merck, Eli Lilly, Johnson & Johnson, Astra Zeneca, Schering Pluogh, etc) as its members & ACS-GCI as the coordinator. The mission of this body is to catalyze the implementation of green chemistry & engineering in the pharmaceutical industry globally. Given that India is emerging as one of the key manufacturing hubs for the world, our effluent volumes and environmental challenges are going to be much higher compared to the challenges of US. Against that background, the initiatives that we all are taking are insufficient. What we are talking about is the quality of Air, Water & Soil of our own country & our own planet. Hence, caring about our environment is every company’s fundamental responsibility. What’s lacking is, we taking responsibility towards our own environment, the environment we live in & the environment our future generations are going to live in. If we can expand our consciousness towards our environment & also look at the larger picture of “sustainability” while taking our day to day decisions in business, it could make a lot of difference.

• What are the future possibilities/advancements in environment wastage

programmes?

• Is your company planning to come out with newer products/services in this area? If yes, kindly name those. What Newreka intends to do in the future is:- 1. Continue to revisit various chemistries (there are only few for which we have

Green Chemistry Solutions currently) and create innovations that enable our customers to make the same drug or pharmaceutical intermediate with improved economics and much lower E – Factor.

2. Evolve our Recycle Solutions to next level so that it can be applied to a wider range of liquid effluents from different products from diverse industry sectors.

3. Explore new catalysts like “Nano Catalysts” for traditional chemistries with a

special focus on the use of “Iron & Iron based Catalysts”. This is in the direction of shifting industries from using Precious Metal Catalysts (most of which are very expensive & hazardous when ultimately disposed off after use) to environmentally sustainable materials like Iron.

4. Sensitize & promote the awareness of Green Chemistry & Green Engineering

in the chemical industry through presentations, sharing successful case studies, sponsoring events (we were the sponsors of Green Chemistry Breakfast Briefing at INFORMEX’09, we were one of the sponsors in the 12th

Annual Green Chemistry & Engineering Conference at Washington), and organizing seminars or workshops (e.g. a workshop on “Industrial Green Chemistry” scheduled for 4th, 5th & 6th Dec’09 that we are organizing in partnership with Green Chemistry Network Center (GCNC), American Chemical Society-Green Chemistry Institute (ACS-GCI), Center for Green Chemistry & Engineering at Yale and Warner Babcock Institute of Green Chemistry).

5. Empower young chemists & chemical engineering students to take on green

chemistry & green engineering through presentations (e.g. our team gave presentations at IIT-Bombay, National College, SIES college, & South Gujarat University), sponsoring various events organized by students (e.g. we sponsored Azeotropy’09 - We mean Green, which was an event organized by chemical engineering students association of IIT-Bombay), organize training programs to train students & teachers in green chemistry, etc.

Interview to Chemical Week Can you first tell me, (in the simplest possible way), what services Newreka provide to Indian chemical companies?

Ans: Newreka is a knowledge based platform which innovates, develops, scales up and commercializes “GREEN CHEMISTRY SOLUTIONS” for the chemical industry especially pharmaceuticals, specialty & fine chemicals, agro chemicals, dyes & pigments industry.

5 – 6 decades back while chemical industry was evolving and chemists were working on developing various chemical processes, to manufacture various chemicals, which would ultimately go for manufacturing products needed by our society, the volumes were quite low. The only considerations used to develop these processes were “Quality” & “Cost”. Since the volumes of these chemicals that point were low, the “Environmental” aspect or impact was not considered since it wasn’t significant. Those chemists never knew that human population in the following decades will grow exponentially and the requirements of these chemicals will increase drastically.

As the population grew & consumerism grew, the volumes in which these chemicals were required went up & manufacturers scaled-up the same processes. Along with the volumes of finished products, the effluents generated also multiplied and we had no idea how to deal with those huge volumes of effluents. So over a period of time, instead of going back to chemistry & reinventing those processes with additional dimension of “Environment” (without compromising on Quality & Cost), we went in the direction of devising various treatment and disposal methods.

At Newreka, what we are doing is revisiting those chemistries/processes, create new knowledge by doing a lot of experiments, customize that new knowledge for our customer’s molecule/product to develop an alternative process, scale-up the process and then commercialize the new process. In short we innovate, develop, scale-up and commercialize Green Chemistry Solutions for our customers. These Green Chemistry based processes or technologies are economically & environmentally much more competitive that the conventional processes/technologies being used by them currently.

And could you please respond to these questions. 1) Are chemical companies in India becoming more conscious of pollution/environmental issues in their manufacturing processes? Ans: Yes the chemical industry is getting more conscious about pollution/environmental issues. The first driving force is pressure from pollution control board, pressure from judicial bodies, etc. Increase in awareness amongst common man about his right to have clean water & clean soil has led to common man filing PILs against various chemical industries (which are causing pollution) & this has led to judicial bodies passing orders on chemical industries to stop polluting water bodies like rivers, canals, etc or close down. The second driving force is pressure on their costing/economics due to increasing global competition. 

2) Do you think that in the last two-three years, an increasing number of chemical companies in the country are trying to improve their processes to reduce emission or pollution? Can you provide us some figures as to how many chemical company clients Newreka had a few years ago, and how many chemical company clients you have now.

Ans: Yes in the last 2 – 3 years an increasing number of chemical companies in India are thinking and wanting to reduce pollution. There still remains a huge gap between “they wanting to reduce pollution” & “they actually taking actions towards reducing pollution”. There is a myth in the industry that taking initiatives like investing on in-house R&D, partnering with other institutions or companies to develop new processes, scaling up & implementing new environmentally friendly technologies, etc is perceived as an expenditure rather than as an investment which has potential to give attractive returns. Most of the companies don’t realize that the fundamental reason behind huge quantities of effluents being generated is inefficiency of their processes. Hence, money invested on research to improve their process & reduce environmental foot print would naturally give huge savings. Most companies also don’t realize that they are as it is spending money on treatment of effluents, disposal of wastes, paying bribes, using unethical means to avoid closure notices, etc. Instead they have a choice to invest the same money on R&D or on other efforts to have an environment friendly technology. There are companies who are realizing that their “wastes is wealth disguised” and are taking concrete steps to explore various possibilities of investing on Green R&D to improve their processes, taking risk of commercializing Green technologies, recovering raw materials & finished products which are currently being guttered in the form of effluents, treating their effluents in such a way that the environmental foot print is minimized, etc. Newreka’s customers in the last 2 years have grown three fold, which is a direct measure of companies coming forward, taking initiatives, willing to invest on Green R&D and to actually do something about their processes & effluents.

3) Is reducing their costs a major factor for this? Or are they genuinely interested in being environmentally-friendly?

Ans: As mentioned above, reducing cost/improving efficiencies and pressure from various regulatory bodies are the major driving forces. Another driving force is, it’s a good marketing

tool. Customers in US & Europe prefer to work with Indian companies having environment friendly processes. Also, it creates a good brand for the company within all communities.

4) Can you tell us who are your important clients in the Indian chemical industry?

Ans:

5) China has been facing a lot of issues related to pollution caused by chemical companies. And now they are beginning to finally address those concerns. How do you see the future for India, as far as environmental consciousness is concerned? Do you think that the companies will have no choice but to adopt more environmentally friendly processes?

Ans: We do keep hearing that China has been facing major pollution problems but one of the good qualities about China is the moment they realize a “Gap” in their approach or way of doing things & they see a possible solution, they move in towards that solution with velocity. During one of our recent meetings with Prof. Paul Anastas (Director, Centre for Green Chemistry & Green Engineering at Yale and also known as the Father of Green Chemistry), we came to know that China over the last couple of years (after they realized the pollution challenges & Green Chemistry as a possible solution for the same) has moved in with velocity to create around Green Chemistry Departments or Activities in around 13 universities across China. In India, we still don’t have a single university where there is a Green Chemistry Department. India as a country has everything that is necessary for its chemical industry to become environment friendly. We have abundance of scientists & research institutes to conduct fundamental research in chemistry & chemical engineering to generate new knowledge in the domain of Green Chemistry. We have quality chemists & chemical engineers who can together scale-up Green Chemistry based technologies. We have abundance of big & medium size companies & MNCs who have sufficient resources to take risk to implement & commercialize Green Chemistry based technologies. We have abundance of resources & funding available through various government agencies to conduct research, develop, scale-up & commercialize Green Chemistry based technologies. What’s missing is only that all these resources we already have, haven’t been mobilized in the direction of expanding industry’s process efficiencies, addressing the major pollution challenges being faced by the industry, creating new knowledge in the domain of Green Chemistry, developing & commercializing Green Chemistry based technologies. 

6) What do you think the Indian government must do to improve the situation or to make companies more responsible for the pollution they create?

Ans: What we are talking about is the quality of Air, Water & Soil of our own country & our own planet. Hence, caring about our environment is every companies fundamental responsibility. It’s actually unfortunate that we need some outside body to make us more responsible towards our own environment, the environment we live in & the environment our future generations are going to live in. The government can create a 5 Year Plan or kind of a road map for creating, sustaining & forwarding Green Conscience in India. What the government can do is empower companies

which are taking initiatives to do R&D, develop, scale-up or commercialize Green Chemistry based technologies, facilitate companies intending to follow Green Chemistry, provide various incentives to companies with environmentally benign processes, etc. What the government can also do is develop & implement new curriculum which imbibes & inculcates Green Conscience in our children right from childhood so that the next generation, in their basic approach, are responsible and care for their own environment. Government can also empower & support colleges & research institutes to create Green Chemistry Departments & include Green Chemistry & Green Engineering as a fundamental subject in B.Sc., M.Sc., B.Tech & M.Tech curriculums.