Vivekanand Education Society’s College of Pharmacy (VESCOP), Mumbai, organised an International Workshop on ‘Regulatory Milestones in Drug Development’, bringing together experts from the pharmaceutical industry, regulatory agencies, scientific research and intellectual property.

The workshop held in collaboration with Hanura Therapeutics, H.A.B.I.T. Foundation and AIPFC (Association IP Facilitation Centre), provided participants with insights into the regulatory journey involved in transforming a drug candidate from laboratory research into a market-ready medicine. 

Discussions covered key stages including drug discovery, research translation, clinical development, regulatory approval, patent protection and commercialisation, along with differences between Indian and US regulatory frameworks.

The expert panel comprised Dr. Manoj Jadhav, CEO, Isha Therapeutics, New Jersey, USA; Dr. Nitin Mali, Pharma Industry Expert, Mumbai; Dr. Sripathi Rao Kulkarni, Senior Principal Scientist, CSIR Innovation Complex, Mumbai; Nilesh Patil, Assistant Controller, Indian Patent Office; and D. R. Gahane, Former Joint Commissioner, FDA. The session was moderated by Dr. Anand Chintakrindi, Associate Professor, VESCOP.

The experts emphasised the importance of robust regulatory frameworks in ensuring the safety, efficacy and quality of medicines, while highlighting the need for stronger interaction between academia, industry, regulators and the intellectual property ecosystem.

Dr. Supriya Shidhaye, Principal, VESCOP, said, “Understanding the regulatory pathway is critical to translating scientific innovation into safe and effective medicines. This workshop allowed participants to learn directly from experts across the regulatory, scientific, industrial, and intellectual property domain.”

Dr. Prakash Lulla, Trustee and Treasurer, VES, said the institution is focused on creating an ecosystem that connects academic learning with industry practices and emerging developments. He highlighted regulatory pathways, intellectual property and drug development as essential areas of knowledge for the next generation of pharmacy professionals.

Dr. Manoj Jadhav, CEO, Isha Therapeutics, said, “Drug development is not limited to scientific discovery; it involves clinical research, regulatory compliance, intellectual property protection, and several other critical stages. Bringing experts from diverse domains together provided participants with a practical perspective on translating innovations from the laboratory into safe and successful medicines.”

The seminar was coordinated by Vijaykumar Shivpuje, Director, Patlex Business Solutions, while at VESCOP, logistics, participant coordination and public relations were managed by Dr. Anand Chintakrindi, Associate Professor; Dr. Sonali Munj, Assistant Professor; and Dr. Shivali Tank, Senior Scientist, Isha Therapeutics.