Dr. Bakhle specialized in Clinical Pharmacology and Clinical Research after doing his MD from Grant Medical College in Mumbai.
He has conducted phase I studies for Hoechst at the JJ Hospital, Mumbai from 1983 to 1988 when clinical research was in nascent stage in India. He moved on to join Glaxo where he created an inhouse Clinical Pharmacology Unit that conducted phase I and bioequivalence studies between 1988 to 1992.
He was appointed as Vice President – Medical by Schering-Plough in India (Fulford) at the age of 33, where he headed medical and regulatory activities. He was responsible for the approval and launch of first 2 Biotech anti-cancer products in India – Interferon and GM-CSF. He moved to Lupin to work as Director of Medical Services in 1995 and was instrumental in Lupin’s foray into global network of TB experts and represented India on the WHO committee on Tuberculosis. He also was involved with the Global Alliance against TB (GATB).
He then worked for Novartis for a brief stint where he was instrumental in creating their global development unit in Mumbai in competition with 8 countries that bid for this prestigious project. This unit is now based in Hyderabad and employs over 10,000 scientists.
He joined Aventis in 2002 and created a clinical research group from scratch to attract global clinical trials to India. He was also instrumental in creating a global medical writing unit for Aventis in India that prepared publications for global Aventis. Subsequently, after acquisition of Aventis by Sanofi, his clinical & regulatory group received 2 global awards from the President of Sanofi successively in 2006 and 2007.
From 2007 to 2009, he headed Reliance Clinical Research Services based in Navi Mumbai as Head of Operations. During this tenure, he created specialized infrastructure in its Bengaluru facility for cardiac TQT studies. In Dec 2009, he rejoined Lupin to head all medical and clinical activities. He headed global medical research activities of Lupin based in Lupin Research Park Pune. He has conducted global clinical studies for different Novel Chemical Entities and Biosimilars being developed by Lupin. He was also on the board of Lupin’s Japanese joint venture company YL Biologics which developed new Biotech drugs for global introduction. He retired from Lupin in September 2023 and working as a free lancing consultant.
He has closely worked with the pharma industry groups like OPPI, where he was the Vice Chairman of medical committee for few years and was also on the technical committee of IDMA. He was a member of several regulatory committees that framed guidelines for GCP, Bioequivalence, IPR, Phase I and Ethical Marketing of Pharmaceuticals etc.
He has been profiled in a book by Tata McGraw-Hill “Thought Leaders” amongst 22 corporate leaders from different sectors of industry.
