The Society for Pharmaceutical Dissolution Science (SPDS) conducted a highly interactive value-adding programme on Dissolution Science on 12 November 2025 at the CDSCO Office, Mumbai Central.
Designed exclusively for Central and State Drug Inspectors of the West Zone and Maharashtra, the workshop focused on strengthening dissolution compliance—an area linked to nearly 40% of Not-of-Standard-Quality (NSQ) cases reported by regulatory testing labs each month.
The initiative received strong support from Central and State Drug Authorities and the Indian Pharmacopoeia Commission (IPC). Although unable to attend in person, Dr. Rajeev Raghuvanshi, Drugs Controller General of India, conveyed his best wishes for the programme.
Senior FDA authorities who attended and enriched the sessions with insightful presentations included Dr. H. G. Koshia, FDA Commissioner, Gujarat; Shri D. R. Gahane, Joint Drugs Controller, Maharashtra; Dr. Santosh Indraksha, Deputy Drugs Controller, CDSCO; and Dr. Pawan Saini, Senior Scientific Officer, IPC, along with several subject-matter experts from SPDS. Their participation offered a strong motivational boost to all delegates.
The event was conceptualised by Dr. L. Ramaswamy, Secretary General, SPDS & Chairman, SOTAX India Pvt. Ltd., and Subramanian R. Vaidya, Executive Member, SPDS & Director, GM Polyplast Ltd. It was organised by Vijay Kshirsagar, Founder President, SPDS & Director, TRAC Pharma Consulting. Dr. Padma Devarajan, President, SPDS, delivered the Presidential Address during the inauguration, while Dr. Munira Momin (Principal, BNCP) and Dr. Krishnapriya Mohanraj (Professor, BCP) compered the event.
This marked the first-ever SPDS programme designed exclusively for regulators, aiming not just to highlight industry issues but also to provide clear Corrective and Preventive Actions (CAPA). Sessions covered key themes such as the importance of dissolution in drug performance, regulatory expectations, method development challenges, and investigating OOS/OOT results. Eminent speakers included Dr. Parizad Elchidana, Vijay Kshirsagar, Pearl Pereira Nambiar, and Rajendra Dadhich.
A lively panel discussion, moderated by Kshirsagar and enriched by inputs from multiple speakers, saw active participation from Dr. Santosh Indraksha, who added regulatory perspectives to the dialogue. Technical demonstrations by Suhas Yewale and Sunil Dubey of SOTAX showcased the correct use and controls of Dissolution Apparatus I & II, drawing keen interest from the audience.
Delegates expressed strong appreciation for the program’s objective: enabling regulators to better evaluate manufacturers’ dissolution testing capabilities while fostering understanding between regulators and the regulated industry.
In a significant forward-looking statement, IPC highlighted its ongoing work to incorporate dissolution methods into several Indian Pharmacopoeia monographs. Dr. Pawan Saini urged industry stakeholders to contribute dissolution methods and data, with SPDS committing to facilitate this collaboration for broader national benefit.