Pharma Times - Vol. 51 - No. 02 - February 2019 7 Pharma Times Conclave, with the theme Transforming ‘Disruptors’ into ‘Enablers’ for Universal Health Care, was held on 24 th January, 2019 at Hotel Orchid, Mumbai. The Conclave was organized to commemorate the completion of 50 years of quality publishing of Pharma Times, the monthly newsmagazine of Indian Pharmaceutical Association (IPA). The event was supported by ACG Worldwide & had the Drugs Controller General (India), Dr. Eswara Reddy as the Chief Guest & Ajit Singh, Chairman, ACG Worldwide, as the Guest of Honor. The Conclave had two panel discussions – on Evolving Regulatory Landscape & Digitization in Pharma Industry. With Rajeev Patil (Regulatory Affairs Consultant), Subodh Priolkar (CEO, Wincoats), Dr. Nilima Kshirsagar (National Chair, Clinical Pharmacology, ICMR, Government of India) & Dr. Eswaran Iyer (IPR Consultant) as panelists in the discussion on Regulatory Scenario that was moderated by Dr. Rao Vadlamudi (Immediate Past President of IPA), the deliberations presented the most recent updates with respect to the various facets that make up the current regulatory climate in the country & impact of the changing / tightening regulatory requirements globally. Regulatory compliance issues & recent updates, especially with respect to 483s & warning letters, global regulatory requirements for use of excipients in drug products, current status of fixed dose combinations (FDCs) and USTR Special 301 Report & India being placed on Priority watch list, pressure on the Indian government to accept ‘TRIPS plus’ provisions & compulsory licensing were some of the elements that were dealt with, during the discussion. The second discussion on Digitization was moderated by Utkarsh Palnitkar (Founder & Managing Partner, Aarna Corporate Advisors) and had Ettore Cucchetti (CEO, ACG Inspections), Sandeep Dewangan (Director, SciTech, ACG Worldwide), Dr. Parizad Elchidana (Chief Technical Officer, Pharmax Pharmaceuticals), Seshnath Chauhan (Director, Global Sourcing, Dr. Reddys Laboratories) & Dr. Rajeev Jain (Co-Founder, ConsilX Digital) as the panelists. Applicability of industry 4.0 to pharma scenario, digital transformation of pharma product infrastructure from manufacturing to dispensing the product to the patients, with drastic changes in business models & global manufacturing operations, software- controlled packaging execution (serialisation and automation/ robotisation), integrated supply chain (traceability and collaboration) & enterprise back-end IT cloud based services (XaaS) utilizing the data from the product supply (analytics, clinical trials, life-cycle management and regulatory compliance reporting), were some of the topics deliberated upon, during the discussion. DCGI, Dr. Eswara Reddy made the closing remarks on both the discussions and emphasized on the need to make the Indian drug regulatory laws more contemporary & exhorted the industry to exercise just as much due diligence in their domestic regulatory submissions as for the global regulatory agencies. He further added that 15 lakh records had been digitized by CDSCO in the last 3 years & also spoke about the Sugam Portal and how digitization has helped them in answering industry queries and reaching out to a greater number of people, in a much faster way. The panel discussions were followed by the Pharma Times Felicitation program. President of IPA, Dr. T. V. Narayana, in his welcome remarks, congratulated Dr. Alka Mukne, Editor, Pharma Times, for successfully organizing the Pharma Times Conclave & Golden Jubilee Celebrations. Dr. Alka Mukne in her presentation highlighted on the challenges faced in distributing over 13,000 print copies, free of cost every month, to IPA members & requested the pharmaceutical, machinery & excipients industry to extend greater support to Pharma Times so as to make it a viable pro-position. Ajit Singh, in his presentation highlighted how India was the top producer of pharmaceutical products and not just one amongst the top three, as was routinely stated. He added that ACG was routinely involved in conducting training programs for the industry professionals & regulators and requested the DCGI to consider deputing the Indian regulators for training to these sessions. DCGI, Dr. Eswara Reddy, in his address, spoke about how proud he was, to be present for the Golden Jubilee Celebrations of Pharma Times. Dr. Reddy continued on the need to put in greater focus on building innovation – based products & further added that there was this burning need for building trust between the industry & the Indian regulators. The last leg of the program included felicitation of the Past Editors of Pharma Times – Founder Editor, Ashok Mehta (1968 – 1988) who founded the magazine & managed it for two decades, Dr. P. M. Nayak (1988 – 1990), Kaushik Desai (1996 – 2004 & 2008 – 2010) & Dr. M. K. Raina (2004 - 2008). Dr. Anil Kapadia (1990 – 1996), who was the Editor immediately after Dr. P. M. Nayak was not present for the function since
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Pharma Times - Vol. 51 - No. 02 - February 2019 7
Pharma Times Conclave, with the theme Transforming ‘Disruptors’ into ‘Enablers’ for Universal Health Care, was held on 24th January, 2019 at Hotel Orchid, Mumbai. The Conclave was organized to commemorate the completion of 50 years of quality publishing of Pharma Times, the monthly newsmagazine of Indian Pharmaceutical Association (IPA). The event was supported by ACG Worldwide & had the Drugs Controller General (India), Dr. Eswara Reddy as the Chief Guest & Ajit Singh, Chairman, ACG Worldwide, as the Guest of Honor.
The Conclave had two panel discussions – on Evolving Regulatory Landscape & Digitization in Pharma Industry. With Rajeev Patil (Regulatory Affairs Consultant), Subodh Priolkar (CEO, Wincoats), Dr. Nilima Kshirsagar (National Chair, Clinical Pharmacology, ICMR, Government of India) & Dr. Eswaran Iyer (IPR Consultant) as panelists in the discussion on Regulatory Scenario that was moderated by Dr. Rao Vadlamudi (Immediate Past President of IPA), the deliberations presented the most recent updates with respect to the various facets that make up the current regulatory climate in the country & impact of the changing / tightening regulatory requirements globally. Regulatory compliance issues & recent updates, especially with respect to 483s & warning letters, global regulatory requirements for use of excipients in drug products, current status of fixed dose combinations (FDCs) and USTR Special 301 Report & India being placed on Priority watch list, pressure on the Indian government to accept ‘TRIPS plus’ provisions & compulsory licensing were some of the elements that were dealt with, during the discussion. The second discussion on Digitization was moderated by Utkarsh Palnitkar (Founder & Managing Partner, Aarna Corporate Advisors) and had Ettore Cucchetti (CEO, ACG Inspections), Sandeep Dewangan (Director, SciTech, ACG Worldwide), Dr. Parizad Elchidana (Chief Technical Officer, Pharmax Pharmaceuticals), Seshnath Chauhan (Director, Global Sourcing, Dr. Reddys Laboratories) & Dr. Rajeev Jain (Co-Founder, ConsilX Digital) as the panelists. Applicability of industry 4.0 to pharma scenario, digital transformation of pharma product infrastructure from manufacturing to dispensing the product to the patients, with drastic changes in business models & global manufacturing operations, software-controlled packaging execution (serialisation and automation/robotisation), integrated supply chain (traceability and collaboration) & enterprise back-end IT cloud based services
(XaaS) utilizing the data from the product supply (analytics, clinical trials, life-cycle management and regulatory compliance reporting), were some of the topics deliberated upon, during the discussion. DCGI, Dr. Eswara Reddy made the closing remarks on both the discussions and emphasized on the need to make the Indian drug regulatory laws more contemporary & exhorted the industry to exercise just as much due diligence in their domestic regulatory submissions as for the global regulatory agencies. He further added that 15 lakh records had been digitized by CDSCO in the last 3 years & also spoke about the Sugam Portal and how digitization has helped them in answering industry queries and reaching out to a greater number of people, in a much faster way.
The panel discussions were followed by the Pharma Times Felicitation program. President of IPA, Dr. T. V. Narayana, in his welcome remarks, congratulated Dr. Alka Mukne, Editor, Pharma Times, for successfully organizing the Pharma Times Conclave & Golden Jubilee Celebrations. Dr. Alka Mukne in her presentation highlighted on the challenges faced in distributing over 13,000 print copies, free of cost every month, to IPA members & requested the pharmaceutical, machinery & excipients industry to extend greater support to Pharma Times so as to make it a viable pro-position. Ajit Singh, in his presentation highlighted how India was the top producer of pharmaceutical products and not just one amongst the top three, as was routinely stated. He added that ACG was routinely involved in conducting training programs for the industry professionals & regulators and requested the DCGI to consider deputing the Indian regulators for training to these sessions. DCGI, Dr. Eswara Reddy, in his address, spoke about how proud he was, to be present for the Golden Jubilee Celebrations of Pharma Times. Dr. Reddy continued on the need to put in greater focus on building innovation – based products & further added that there was this burning need for building trust between the industry & the Indian regulators.
The last leg of the program included felicitation of the Past Editors of Pharma Times – Founder Editor, Ashok Mehta (1968 – 1988) who founded the magazine & managed it for two decades, Dr. P. M. Nayak (1988 – 1990), Kaushik Desai (1996 – 2004 & 2008 – 2010) & Dr. M. K. Raina (2004 - 2008). Dr. Anil Kapadia (1990 – 1996), who was the Editor immediately after Dr. P. M. Nayak was not present for the function since
Pharma Times - Vol. 51 - No. 02 - February 2019 8
Dr. T.V. Narayana, President - IPA welcoming the gathering
Panelist (L to R) Subodh Priolkar, Dr. Rao V.S.V. Vadlamudi, Dr. Nilima Kshirsagar, Dr. Eswaran Iyer and Rajeev Patil speaking
Panelists of the discussion on Digitization in Pharma Industry (L to R) Sandeep Dewangan, Dr. T.V. Narayana, DCGI, Dr. S. Eswara Reddy, Utkarsh Palnitkar, Dr. Parizad Elchidana, Ettore Cucchetti, Dr. Rajesh Jain, Seshnath Chauhan,
Ajit Singh and Dr. Alka Mukne
Panelists of the discussion on Evolving Regulatory Landscape (L to R) Rajeev Patil, Subodh Priolkar, Dr. T.V. Narayana, DCGI, Dr. S. Eswara
Reddy, Ajit Singh, Dr. Nilima Kshirsagar, Dr. Eswaran Iyer, Dr. Rao V.S.V. Vadlamudi and Dr. Alka Mukne
Seated (L to R) Dr. T. V. Narayana, President - IPA, DCGI, Dr. S. Eswara Reddy, Ajit Singh, Chaiman - ACG, Dr. Alka Mukne,
Editor - Pharma TimesDr. Alka Mukne, Editor – Pharma Times making the
Pharma Times presentation
he was out of country. Past Presidents of IPA – B. N. Thakore (1984 – 1986), Dr. P. M. Nayak (1992 – 1994), Subodh Priolkar (2004 – 2008), Dr. JAS Giri (2012 – 2014) & Dr. Rao Vadlamudi (2014 - 2018); Past Hon. Gen. Secretary, S. D. Joag, Editorial team members, sponsors, key advertisers and print partner of Pharma Times and IPA Secretariat members were also honoured for their contribution to Pharma times in its 50 year journey.
The program was a resounding success, with over 120 participants from amongst the pharma industry leaders, regulators & policymakers. Dr. Alka Mukne was the Convener of the Conclave & Dr. T. V. Narayana presided over the function.
Panelist (L to R) Ettore Cucchetti, Sandeep Dewangan, Seshnath Chauhan, Dr. Rajesh Jain, Dr. Parizad Elchidana and Utkarsh Palnitkar speaking
Pharma Times - Vol. 51 - No. 02 - February 2019 8
Pharma Times - Vol. 51 - No. 02 - February 2019 9
Dr. P. M. Naik (2nd from right), Past Editor- Pharma Times (1988-1990)Kaushik Desai (1st from left), Past Editor- Pharma Times
(1996 - 2004 & 2008 – 2010)
A. I. Mehta (3rd from left), Founder Editor – Pharma Times (1968 – 1988)Dr. P.B.N. Prasad, Dy. Drugs Controller (India), felicitating Dr. T. V. Narayana, President - IPA
Chief Guest, DCGI, Dr. S. Eswara Reddy speaking
Dr. P. B. N. Prasad, Dy. Drugs Controller (India), felicitating Ajit Singh, Chairman - ACG
PHaRma TImEs fELICITaTIons
DCGI, Dr. S. Eswara Reddy being felicitated by Ajit Singh
Guest of Honor, Ajit Singh addressing the delegates
Pharma Times - Vol. 51 - No. 02 - February 2019 9
Pharma Times - Vol. 51 - No. 02 - February 2019 10
Subodh Priolkar (2nd from left), Past President - IPAB. N. Thakore (3rd from left), Past President - IPA
Dr. M. K. Raina (1st from left), Past Editor - Pharma Times (2004 - 2008) Dr.Alka Mukne (1st from right), Editor - Pharma Times (2010 - to date)
Dr. J.A.S. Giri (2nd from left), Past President - IPA Dr. Rao V.S.V. Vadlamudi (2nd from left), Past President - IPA
Ketan Parmar (1st from left), ACGS.D. Joag (1st from left), Past Hon. Gen. Secretary - IPA
Pharma Times - Vol. 51 - No. 02 - February 2019 10
Pharma Times - Vol. 51 - No. 02 - February 2019 11
Suresh Khanna (1st from left), Hon. Gen. Secretary, IPA Dr. Hemant Mondkar (1st from left), Hon. Treasurer, IPADr. S. Vidyadhara (2nd from left), Chair
Person - Education Division, IPA
Shehul Sheth (2nd from left), Director - Accupack
Raj Vaidya (1st from left), Member, Editorial Board - Pharma TimesDr. Subhash C. Mandal (2nd from left), Member, Editorial Board - Pharma Times & Chair Person - Regulatory Affairs Division, IPA
Dr. Sunil Bambarkar (1st from left), Managing Director - Gattefosse
Samuel Mathai (1st from left), Ebenezer Printing House
Manjiri Gharat (1st from left), Chair Person - Community Pharmacy Division, IPA
J. Jayaseelan (1st from left), Chair Person - Industrial Pharmacy Division, IPA
Dr. Divakar Goli (2nd from left), Editor - IJPS T.B. Nair (2nd from right), Coordinator - IPA Seline Dantes (1st from left), Secretariat - IPA
Pharma Times - Vol. 51 - No. 02 - February 2019 11
Pharma Times - Vol. 51 - No. 02 - February 2019 12
Kishore Chavan (1st from left), Secretariat - IPASatish Sonar (1st from left), Marketing Executive -
Pharma Times Vijay Shinde (1st from left), Secretariat - IPA
Misbah Momin (1st from left), Editorial Assistant - Pharma Times
Pranav Bhagwat (3rd from left), Editorial Assistant - Pharma Times
Sean Saldanha (2nd from left), Editorial Assistant - Pharma Times
Shubhangi Kamalia (2nd from left), Editorial Assistant - Pharma Times
Shailaja Sashikumar (2nd from left), Editorial Assistant - Pharma Times
Sania Kothari (2nd from left), Editorial Assistant - Pharma Times
Neha Dabholkar (3rd from left), Editorial Assistant - Pharma Times
Arujn Jeswani (2nd from left), Editorial Assistant - Pharma Times
Pooja Kulthe (1st from left), Editorial Assistant - Pharma Times
Tamanna Gidwani (2nd from left), Editorial Assistant - Pharma Times
Vibhusha Dube (2nd from left), Editorial Assistant - Pharma Times
Rasika Dharap (2nd from left), Editorial Assistant - Pharma Times
Pharma Times - Vol. 51 - No. 02 - February 2019 12
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