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1 Organiser : Supported by : Andhra Pradesh Pollution Control Board Green Chemistry & Engineering Pharma Week on Green Chemistry & Engineering enabling greater business value for an environmentally responsible Pharma supply chain th th February 2017 Brief Report Knowledge Partner : Day I Conference Sponsor : Green Chemistry Research Partner : Media Partners : Pharmaceutical Roundtable CSIR IICT Associate Partners : Cause Partners : SUVEN Life Sciences NAKODA CHEMICALS LTD.

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3 th th A Green Chemistry & Engineering Pharma Week for the Pharma supply chain in India was held between 20 to 24 February 2017 in Visakhapatnam & Hyderabad India's largest Pharma hub cities. Green ChemisTree Foundation, an India based NGO, collaborated with the ACS Green Chemistry Institute Pharmaceutical Roundtable (GCIPR) and Pharmaceutical Supply Chain Initiative (PSCI) to organise a week long initiative on Green Chemistry & Engineering enabling greater business value for an environmentally responsible pharma supply chain, starting with a th st nd two day Conference on 20 & 21 Feb.'17 in Vishakhapatnam, followed by a CEO Roundtable in Hyderabad on 22 Feb.'17 and rd th one to one meetings with selected Indian Pharma companies on 23 and 24 Feb.'17. The Conference was attended by 165 representatives of Indian Pharma Industry across two days; and Inaugurated by Dr. A. Ravi Shankar, Director General, Drugs Control Administration, Govt. of Andhra Pradesh, along with Mr. Bhaskar Rao, Zonal Officer Visakhapatnam, Andhra Pradesh Pollution Control Board (APPCB). GCIPR and PSCI had its member companies' senior representatives participate as speakers and experts to deliberate to deliberate on the theme of the Conference. The delegation included: Dr. David Constable, Director, American Chemical Society Green Chemistry Institute (ACS GCI). Dr. Juan Colberg, Former Co chair, ACS GCI Pharmaceutical Roundtable; Sr. Director Technology & Green Chemistry Leader, Pfizer Inc. Dr. Ingrid Mergelsberg, Director Process Chemistry, MSD. Steven Meszaros, Former Chair, Pharmaceutical Supply Chain Initiative (PSCI); Sr. Director of Business Resilience and Business Development, Pfizer Inc. Dr. Rajappa Vaidyanathan, Group Director Chemical, Synthetic and Analytical Development, Bristol Myers Squibb. Dr. Birgit Skuballa, Head of HSE Management Systems & Audits, Bayer AG. Shelly Shope, CIH, HSE Advisor Elanco Animal Health, Eli Lilly & Co. Richard Davis, Director of Global Environment, Health & Safety, Pfizer Inc. The CEO Roundtable was attended by 50+ senior representatives and leaders of Indian Pharma companies; out of which 11 companies took the opportunity of having one to one meeting with the GCIPR and PSCI delegation. The week long initiative was supported and endorsed by key Pharma stakeholders including Department of Pharmaceuticals, Govt. of India; Pharmaceuticals Export Promotion Council of India (PHARMEXCIL); Bulk Drugs Manufacturers Association (BDMA) and Organisation of Pharmaceutical Producers of India (OPPI). The ACS GCIPR sponsored Day I of the Conference, CEO RT and the one to one meetings. The Conference was also supported by Indian Pharma companies including Natco Pharma Ltd., Hikal Ltd., Suven Lifesciences, Laurus Labs., Dr. Reddy's Laboratories and Nakoda Chemicals. Overall Outcome & way forward: The structure of the Conference, CEO and one to one meetings enabled participation of India Pharma companies at various levels (Management, mid management, R&D, Plant & Operations and EHS) to pro actively engage in the relevance, opportunities and barriers of adopting Green Chemistry & Engineering (GC&E) tools and practices. The Conference served as a facilitating platform for connecting Indian Pharma supply chain to its global Pharma partners for converging on a single agenda of GC&E implementation; and get introduced to the two International platforms viz.: ACS Green Chemistry Institute Pharmaceutical Roundtable (GCIPR) and Pharmaceutical Supply Chain Initiative (PSCI) for exploring collaborative model and approaches for enhancing GC&E industrialisation. The special address by the Head of Sustainable Finance, Nordea Wealth Management Mr. Sasja Beslik, stressed how investments in almost 100 large Pharma companies in India is undergoing a process of re evaluation in the light of disturbing evidence of water pollution found as a result of API pharma manufacturing. Speakers from India and abroad talked about the need for GC&E, shared successful case studies and discussed future prospects. The panel discussion brought forth ideas on integrating GC&E culture amongst Pharma supply chain in India. The meetings brought forth intense discussions on issues related AMR (Anti Microbial Resistance) and highlighted the importance of GC&E implementation for preventing and minimising effluent generation at source. 3

4 The exhibition feature connected solution providers offering environmental and GC&E solutions including Biocatalysts, 'green' solvents, 'green' engineering solutions, recycle at source technologies, simulation technologies, wealth out ofwastewater solutions, co processing and ZLD solutions. The participants got inspired to start engaging in GC&E set of tools including solvent selection guide, Process Mass Intensity/LCA calculator, reagent guide, etc. Engaging participation by Industry audience and active Q&A sessions indicated increasing inclination to adopt GC&E into their existing practices. On various occasions intense discussions were brought forth on issues related AMR (Anti Microbial Resistance) and highlighted the importance of GC&E implementation for preventing and minimising effluent generation at source. The exhibition feature connected solution providers offering environmental and GC&E solutions including Biocatalysts, 'green' solvents, 'green' engineering solutions, recycle at source technologies, simulation technologies, wealth out ofwastewater solutions, co processing and ZLD solutions. Over 65% participants participated in the Benchmarking survey on GC&E adoption gave insights into how and to what extent Indian Pharma companies are integrating GC&E principles, tools and practices. Overall, the interactions and potential collaboration with these International Bodies offered new possibilities to address the industry's environmental challenges and upgrade the standard of compliances thus encouraging the move up the waste hierarchy by reducing pollution at source. The participants recognised the need to measure PMI as a metric if it is to be monitored and there is compelling evidence from practitioners of GC that show a relation between PMI and cost. A cultural change is needed for a healthy outlook towards audits. The talent pool in the Pharma industry is gearing up towards taking up this challenge of GC for improving the bottomline. Vocabulary usage of green metrics is important for Green Chemistry awareness and implementation within the R&D group and Manufacturing functions in the organisation. It was encouraging to see that GC was seen as a means to reduce cost and environmental pressure and improve productivity. Participating industry recognised that the environmental challenges of the industry could be alleviated by adopting GC metrics, training modules, appropriate waste management strategies, built in at plant design stage, stronger compliance systems through EHS audits and professional approach towards the functioning of CETPs found agreement across the board. It was impressed upon the industry that environmentally conscious supply chain players would be able to reduce the business risk to a considerable extent. The speed of the changes in the process was an issue highlighted often. The experts from the international bodies stressed that changes in processes by the technology supplier made in collaboration with the customer needs to be backed up with genotoxicity studies to speed up the regulatory approval process. A strong business case complete with cost benefit analysis is required to speed up the customer approval process. Conclusion and Feedback The Green Chemistry & Engineering Pharma Week, as India's flagship initiative brought together key stakeholder bodies of Indian Pharma Industry including top Pharma MNCs having manufacturing facilities and extensive supply chain in India, Indian Pharma Companies, Govt. bodies, Regulatory agencies, Industry Associations, Research Institutes and solution providers. Perhaps for the first time, these diverse key bodies came together to deliberate on a single agenda of creating an environmentally responsibly Pharma supply chain in India through the applications of Green Chemistry & Engineering tools and practices. The enthusiastic representation from over 100 Indian Pharma companies and their highly engaging participation over the week long events is an indicator of the increasing felt need of the subject and justifies the timeliness of this initiative. One of the common feedbacks received from all the participants is the need for similar interactive forums and capacity building platforms over the coming years. The Conference presentations and a detailed Report can be downloaded for free by signing up at the following webpage: 4

5 Two day Conference & Exhibition on Green Chemistry & Engineering enabling greater business value for an environmentally responsible pharma supply chain th st on February 2017 at The Gateway Hotel, Beach Road, Visakhapatnam The Conference was Inaugurated by Dr. A Ravi Shankar, Director General, Drugs Administration Control, Govt. of Andhra Pradesh; Mr. Bhaskar Rao, Zonal Officer Visakhapatnam, Andhra Pradesh Pollution Control Board; Dr. David Constable, Director, ACS Green Chemistry Institute; Dr. Juan Colberg, Sr. Director Technology & Green Chemistry Leader, Pfizer Inc.; Steve Meszaros, Past Chair, Pharmaceutical Supply Chain Initiative; & Mr. Nitesh Mehta, Co founder & Director, Green ChemisTree Foundation The Conference received encouraging participation from over 165 senior representatives of Pharma API Industry across two days. Keynote Talk Green Chemistry & Engineering enabling greater business value for an environmentally responsible Pharma supply chain by David Constable, Ph.D., Director, ACS Green Chemistry Institute (ACS GCI) 5

6 Green Chemistry Initiatives of the ACS GCI Pharmaceutical Roundtable by Juan Colberg, Ph.D., Sr. Director Technology & Green Chemistry Leader, Pfizer Inc. Implementing a Green Chemistry programme by Ingrid Mergelsberg, Ph.D., Director, Process Chemistry, MSD Green Chemistry Case Study by Rajappa Vaidyanathan, Ph.D., Group Director Chemical, Synthetic and Analytical Development, Bristol Myers Squibb Scalable green chemistry Case studies in API manufacturing by K. J. Satyanarayana, Ph.D., Chief Research Scientist Chemical R&D, Hospira, A Pfizer Co. General PSCI Overview by Steven Meszaros, Senior Director of Business Resilience and Business Development, Pfizer Inc. Past Chair of PSCI 6

7 Panel discussion on Green Chemistry in supply chain expectations of MNCs, opportunities and challenges Moderators : David Constable & Nitesh Mehta Panellists : Juan Colberg, Ravi Raghvan, Ingrid Mergelsberg, Birgit Skuballa & Vilas Dahanukar Keynote Talk Sustainable investing in emerging markets by Sasja Beslik, Head of Sustainable Finance, Nordea Wealth Management Successful case studies PSCI Principles by Shelly Shope, CIH, HSE Advisor Elanco Animal Health, Eli Lilly and Company Using the PSCI tools to self assess your operations by Birgit Skuballa, Ph.D., Head of HSE Management Systems & Audits, Bayer AG 7

8 Expectations for overall environmental management performance and reputation matters by Richard Davis, Director of Global EHS, Pfizer Inc. Development of Greener Chemical Processes for Generic Active Pharmaceutical Ingredients by Vilas Dahanukar, Ph.D., Chief Scientist Process R&D, Integrated Product Development Organization, Dr. Reddy's Laboratories Ltd. Presentations by solution providers CSIR Indian Institute of Chemical Technology by Rajendra Reddy, Ph.D., Principal Scientist, CSIR Indian Institute of Chemical Technology (CSIR IICT) TM Solutions : An effective alternative to endof the pipe treatment by Nitesh Mehta, Founder Director, Newreka Green Synth Technologies Pvt. Ltd. Enzymes in green chemistry by Suresh Kumar Kannapogu, Project Leader, Advanced Enzymes Technologies Ltd. Zero Liquid Discharge Solution for Pharmaceutical Industry by Hemant Wagh, Asst. Vice President, Praj Industries Ltd. 8

9 Innovation Drives Green Growth by Praveen Gosain, Regional Director India, S.E Asia & Australia, Corning India Pvt. Ltd. Green Solutions for Pharmaceutical Industry by Shirish Paranjpe, Manager Marketing Support, Godavari Biorefineries Ltd. ACD Labs for Greener Chemistry by K. K. Bhagchandani, Senior Director Asia & Pacific Business, ACD Labs Creating value from Waste Water by Vikram Dhumal, Head Technology, Geist Research Pvt. Ltd. Co processing solution for environmentally sound management of wastes by Ulhas Parilkar, Director, Geocycle India at ACC Limited 9

10 Eight companies & Research Institute participated in the Exhibition as Solution Providers Advanced Enzymes Technologies Ltd. Corning Technologies Ltd. Geist Research Ltd. Geocycle India Godavari Biorefineries Ltd. CSIR Indian Institute of Chemical Technology (CSIR IICT) & Green Chemistry Research Partner for the Conference Newreka Green Synth Technologies Pvt Ltd. Praj Industries Ltd. 10

11 Tree plantation certificates in their honour Networking & interaction with Speakers 11

12 Pharma CEO / Leadership Roundtable Meeting on Green Chemistry & Engineering enabling greater business value for an environmentally responsible Pharma supply chain nd on 22 February 2017 at Hotel AVASA, Hyderabad, India Welcome by Partners & Organisers (L to R) by Dr. David Constable, Director, ACS Green Chemistry Institute, Sri. Jayant Tagore, President, BDMA, Sri. Ravi Uday Bhaskar, Director General, PHARMEXCIL, Nitesh Mehta, Co founder & Director, Green ChemisTree Foundation, Stevan Meszaros, Sr. Director Business Development & Business Resilience, Pfizer Inc. & Past Chair, Pharmaceutical Supply Chain Initiative (PSCI), & Dr. Juan Colberg, Sr. Director Technology & Green Chemistry Leader, Pfizer Inc. & Past Co Chair Green Chemistry Pharmaceutical Roundtable (GCIPR) Keynote Talk : Future of Phama Industry & Value Additon through Green Chemistry & Engineering by David Constable, Ph.D., Director, ACS Green Chemistry Institute Special address by Sasja Beslik, Head of Sustainable Finance, Nordea Wealth Management The Roundtable Meeting was attended by over 40 CXOs and leaders of Pharma Industry 12

13 Sharing by GCIPR members about value creation for their organziation by Ingrid Mergelsberg, Ph.D., Director, Process Chemistry, Merck & Co., Inc. / MSD Overview of ACS GCI Pharmaceutical Roundtable by Juan Colberg, Ph.D., Sr. Director Technology and Green Chemistry Leader, Pfizer Roundtable discussion on "Possibilities of engagement with GCIPR & PSCI in future." Sharing of experiences, concerns by Industry leaders and exploring collaborative approach for driving GC&E implementation Tree plantation certificates in their honour 13

14 Networking & interactions with GCIPR & PSCI delegation One to One Meetings rd th on February 2017 at Hotel AVASA, Hyderabad, India One to One Meetings with Green Chemistry & Engineering delegation from (GCIPR & PSCI) 11 Indian Pharma companies participated in the One to One Meetings Suven Life Sciences Ltd. Neuland Laboratories Limited Laurus Labs Ltd. Hetero Drugs Ltd. DSM Sinochem Pharmaceuticals India Pvt. Ltd. Dr. Reddy's Laboratories 14