“Green Chemistry & Engineering enabling

greater business value for an environmentally

responsible Pharma supply chain”

th th20 ‐ 24 February 2017

Day‐I Conference Sponsor :

Supported by :

Pharmaceutical Roundtable

Organiser :

Green Chemistry & Engineering Pharma Week on

Brief Report

Knowledge Partner :

Associate Partners : Cause Partners :

Green Chemistry Research Partner :

Media Partners :

CSIR‐IICT

NAKODA CHEMICALS LTD.

Andhra Pradesh

Pollution Control Board

Life SciencesSUVENwww.suven.com

www.GreenChemisTree.co.in

th thA 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 Pharmaceutical Supply Chain Initiative (GCIPR) and (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 ndtwo‐day Conference on 20 & 21 Feb.'17 in Vishakhapatnam, followed by a CEO Roundtable in Hyderabad on 22 Feb.'17 and rd thone‐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.

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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‐of‐wastewater 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‐of‐wastewater 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: http://www.industrialgreenchem.com/downloads/SignUp.html

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Keynote Talk ‐ Green Chemistry & Engineering enabling greater business value for an environmentally responsible Pharma supply chainby David Constable, Ph.D., Director, ACS‐Green Chemistry Institute (ACS‐GCI)

Two‐day Conference & Exhibition on Green Chemistry & Engineering enabling greater

business value for an environmentally responsible pharma supply chainth ston 20 ‐ 21 February 2017 at The Gateway Hotel, Beach Road, Visakhapatnam

The Conference received encouraging participation from over 165 senior representatives of Pharma API Industry across two days.

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

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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

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

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Keynote Talk ‐ Sustainable investing in emerging markets bySasja 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

Moderators : David Constable & Nitesh Mehta

Panellists : Juan Colberg, Ravi Raghvan, Ingrid Mergelsberg, Birgit Skuballa & Vilas Dahanukar

Panel discussion on Green Chemistry in supply chain ‐ expectations of MNCs, opportunities and challenges

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Enzymes in green chemistry by

Suresh Kumar Kannapogu, Project‐Leader, Advanced Enzymes

Technologies Ltd.

CSIR‐Indian Institute of Chemical Technology by

Rajendra Reddy, Ph.D., Principal Scientist, CSIR‐Indian Institute of

Chemical Technology (CSIR‐IICT)

Zero Liquid Discharge Solution for Pharmaceutical Industry by

Hemant Wagh, Asst. Vice President, Praj Industries Ltd.

TMRecycle@Source Solutions : An effective alternative to end‐

of‐the pipe treatment by

Nitesh Mehta, Founder Director, Newreka Green Synth

Technologies Pvt. Ltd.

Expectations for overall environmental management ‐

performance and reputation matters by

Richard Davis, Director of Global EHS, Pfizer Inc.

Presentations by solution providers

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.

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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

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.

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Geist Research Ltd.

Godavari Biorefineries Ltd.

Geocycle India

CSIR‐Indian Institute of Chemical Technology (CSIR‐IICT) &

Green Chemistry Research Partner for the Conference

Newreka Green Synth Technologies Pvt Ltd. Praj Industries Ltd.

Advanced Enzymes Technologies Ltd.

Eight companies & Research Institute participated in the Exhibition as Solution Providers

Corning Technologies Ltd.

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Tree plantation certificates in their honour

Networking & interaction with Speakers

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Keynote Talk : Future of Phama Industry & Value Additon

through Green Chemistry & Engineering by

David Constable, Ph.D., Director, ACS‐Green Chemistry Institute

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)

Pharma CEO / Leadership Roundtable Meeting on

Green Chemistry & Engineering enabling greater business value for an

environmentally responsible Pharma supply chainnd

on 22 February 2017 at Hotel AVASA, Hyderabad, India

The Roundtable Meeting was attended by over 40 CXOs and leaders of Pharma Industry

Special address by Sasja Beslik, Head of Sustainable Finance, Nordea Wealth

Management

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Sharing of experiences, concerns by Industry leaders and exploring collaborative approach for driving GC&E implementation

Roundtable discussion on "Possibilities of engagement with GCIPR & PSCI in future."

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

Tree plantation certificates in their honour

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Networking & interactions with GCIPR & PSCI delegation

One‐to‐One Meetingsrd thon 23 ‐ 24 February 2017 at Hotel AVASA, Hyderabad, India

One‐to‐One Meetings with Green Chemistry & Engineering delegation from (GCIPR & PSCI)

Suven Life Sciences Ltd. Laurus Labs Ltd.Neuland Laboratories Limited

Hetero Drugs Ltd.DSM Sinochem Pharmaceuticals India

Pvt. Ltd.Dr. Reddy's Laboratories

11 Indian Pharma companies participated in the One‐to‐One Meetings

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