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An elected Board of Directors leads ISPE India Affiliate. There are committees comprised of member volunteers, with each committee responsible for one of the Chapter’s core activities. While the Board defines the Chapter’s overall vision, mission and goals, the committees make the Affiliate hum. All members are encouraged to work with a committee and help the Affiliate fulfill its mission. Your talents will find a purpose, your network will grow and your efforts will be greatly appreciated!
This group of distinguished leaders represents a variety of Pharmaceutical Industry disciplines. The ISPE India board of directors is responsible for the governance and strategic direction of the society and has assumed their positions at the ISPE India’s Annual General meeting held on September 22, 2016.
Chairman Emeritus: Mr. Ajit Singh
Ajit Singh is Chairman of ACG Worldwide, the Associated Capsules Group of Companies in Bombay. He is the Chairman Emeritus of ISPE India Affiliate as well as one of its founder members. He was educated at Millfield School and Cambridge University in England, and did his post-graduate studies at the Harvard Business School, U.S.A.
Ajit Singh has played a prominent role in the development of the Pharmaceutical and Allied Industry in India. He has served on the Managing Committees of the major Pharmaceutical Associations in India and was a Vice President and Chairman of several Committees of the Organisation of Pharmaceutical Producers of India (OPPI). As part of his non-pharma activity, he served for many years on the Central Governing Council of the Indian Institutes of Technology (IITs), and also on the Board of Governors of the National Institute of Training in Industrial Engineering (NITIE). Both appointments made by the President of India.
Chairman: Mr. Kapil Bhargava
Mr. Kapil Bhargava is M. Pharm in Pharmaceutical Chemistry. He retired as Dy. Drugs controller (I) CDSCO with an overall experience of more than 36 years in enforcement of Indian drug rules, manufacture and testing of pharmaceuticals and as an academician. For many years he was involved in implementation of WHO – GMP certification scheme, inspection of Pharmaceuticals and Biologicals. with inspecting agencies from United Nations & European Commission and others. He has been WHO Expert and Advisor on quality of biological products. He has reviewed articles in Pharmaceutical Engineering journal, PDA Bulletin (Europe) and is on the Editorial board of Pharma Review (India) and other journals. He is advisor to few pharmaceutical companies and trade associations in private and public sector.
Vice Chairman: Dr. A.K. Singal
Dr. Singal, presently working for Glatt (India) Engineering Private Ltd. as 'Strategic Advisor', has been successfully running "Pharmaceutical Engineering' expertise for the past 25 years. He is a member of ISPE and one of the Founder Director of ISPE India Affiliate. Professionally, he is a practicing Surgeon with a Master's degree and obtained specialized training certificates from Universitat Grossharden, Munich and Herne from Germany.
Vice Chairman: Dr. Uday Shetty
Dr. Shetty is currently involved in non–profit activities of providing free of cost educational materials to Pharmaceutical Professionals. Dr. Shetty has experience in quality management, product development, technology transfers and commercial production. He also has Supervisory experience in support functions like EHS, engineering and purchase. In the immediate past he was the Director at a Contract Research Organization, which he co-founded. Before that he was in leading Pharmaceutical companies like Janssen, GSK and Wyeth.
Secretary: Mr. Satish Bhadri
Mr. Satish Bhadri is Managing Director of Envirochem Tech Solutions (I) Pvt. Ltd. He is a Chemical engineer from IIT Kanpur. He has been working in the field of Industrial Water Treatment for last 35 years, particularly specialized in High Purity water Treatment for Pharma Industry. He is considered as an authority on High Purity Water treatment generation and distribution systems to qualify USFDA. Presently, he is also working as a consultant & technical adviser to many European companies setting up projects across the world. He has been speaking as a guest speaker at events organized by WHO, IDMA, BDMA and similar forums in India and abroad on Water treatment Technology.
Treasurer: Mr. Vijay Kshirsagar
Mr. Vijay Kshirsagar is a highly experienced, hard-core Quality, Regulatory & Analytical professional with 38+ years of rich experience in highly reputed Indian & Multinational Pharmaceutical firms. Till end April 2013, he worked for Unichem Laboratories Limited as Executive Vice President responsible for Corporate Quality, Regulatory, Analytical Research & Packaging Development based in Mumbai for about seven years. Prior to Unichem he worked for Ranbaxy, Sun Pharma, Lupin, IPCA, German Remedies & Tata Pharma. He has successfully represented his company in US and UK courts regarding IP related matters. He is the President of Society for Pharmaceutical Dissolution Science. Recently he has formed his own Pharma Consultancy called TRAC offering specialized services globally, for cGMP Training, Regulatory Filings, Auditing & Compliance. His current clients include reputed pharma companies based in India, China, US, Europe, Turkey, Jordan, Bangladesh, Kenya & Oman.
Immediate Past Chairman and Director : Mr. R. Raghunandanan
Mr. R. Raghunandanan holds a Masters Degree in Organic Chemistry and also has Business Management qualifications from Mumbai University. He worked with GlaxoSmithKline Pharmaceuticals Limited, for more than 32 years and retired as Vice President – Quality for South Asia region. During his tenure he held several responsible positions with increasing responsibilities at the various manufacturing Quality units as well as the Corporate Quality function of GlaxoSmithKline in India and the South Asia region. He was the Chairman of ISPE (International Society for Pharmaceutical Engineering) India Affiliate during the period 2014-16. Currently he is a Pharma Consultant based in Mumbai.
Past Chairman and Director : Mr. Gopal Nair
Mr. Gopal Nair graduated in Chemistry with honors from Ramnarain Ruia College, worked in Rapttakos Brett for a short while and he left for the UK for further studies. In the UK he obtained graduate and post- graduate degrees from London University while working in Sandoz. He joined GSK (Glaxo) and was transferred to Worli, Bombay. In Glaxo he rose to the position of Technical Director on the Board of Glaxo India. Mr. Nair was active in OPPI and helped co-author the GMP Guide. He also helped in Training the Asia Pacific staff in Singapore. Mr. Nair teaches Narsee Monjee management school (NMIMS) as a visiting faculty, in its Pharmaceutical Management course. After retiring from GSK he helped in launching ISPE in India along with Mr. Ajit Singh.
Director: Mr. Sipahimalani
Mr. Sipahimalani is a BSc (Chemistry), B. Pharm Hons. London University, MRSC. Subsequently he worked in Quality Control Department of University College Hospital in London and Pharmacology Department of BDH Ltd in UK for number of years. He returned to India in 1961. Mr. Sipahimalani was selected as a fellow of Royal Pharmaceutical Society of Great Britain in 1979 for distinction in pharmaceutical sciences. Mr. Sipahimalani is an Associate Editor of Indian Drugs and IDMA Bulletin and Editor of APA Forum. He has been Chairman of the Technical & Quality Management Subcommittee of IDMA continuously since about 20 years. He was actively involved in and contributed to the preparation of IP 1985, IP 1996, 2007, 2010 and subsequent amendments thereof. He was also the chairman of IDMA’s scientific Committee for Indian Herbal pharmacopoeia.
Mr. Sipahimalani is chairman of a committee of Experts of Scientific Body of IPC.
Director: Mr. S.M. Mudda
Mr. S.M. Mudda is currently working as Director, Global Strategy - Technical for Micro labs, Bangalore. He is a Pharmacy graduate with postgraduate Diploma in Management studies. He is a pharmaceutical industry professional with 40 years experience in India covering disciplines like Technical, Quality Systems, Regulatory, Project Management, Training, Education, Leadership Development and General Management.
Mr. Mudda is passionate about implementation of best practice in Pharmaceutical Quality System (PQS) for creating a culture of quality across the organization. He is well connected with global thought leaders in the areas of quality and regulatory management and has been a speaker at various national and international forums. He is actively engaged with Government and Regulators for policy matters related to pharmaceutical industry as Chairman, Regulatory Affairs Committee, of IDMA. He is also a member of Scientific Body , Indian Pharmacopoeia commission, Ghaziabad.