SPDS to conduct Dissolution Science training programme for regulators in collaboration with DCGI, IPC and Maharashtra FDA

The Society for Pharmaceutical Dissolution Sciences (SPDS) has announced that it will conduct a Training Programme on Dissolution Science exclusively for regulators, in collaboration with the Drug Controller General of India, the Indian Pharmacopeia Commission and the Maharashtra State FDA. The programme will take place on 12 November 2025 at CDSCO, Mumbai.

SPDS states that it has conducted several programmes on Dissolution Science in the past, but this will be the first time that the organisation is holding a session specifically for regulators. According to SPDS, dissolution properties of drug products have a direct impact on efficacy, safety and quality, making compliance essential. The organisation notes that both central and state testing laboratories report a significant number of products each month that fall under the not of standard quality (NSQ) category, with around 30 per cent of these cases involving dissolution compliance issues.

SPDS says that corrective action is needed from both manufacturers and regulators. The objective of the programme is to support regulators in assessing manufacturing and testing capabilities related to dissolution compliance. Industry representatives and subject matter experts from SPDS will share their experience and observations. The organisation states that the programme is intended to facilitate knowledge sharing between regulators and industry, allowing inspectors to understand perspectives from both sides.

The programme was conceived by Dr L Ramaswamy, Founder and Chairman, SOTAX India Pvt. Ltd., and Mr Subramanian R Vaidya, Director, GM Polyplast Ltd. The topics were organised by Mr Vijay Kshirsagar, Founder President of SPDS and Freelance Pharma Consultant, in coordination with stakeholders.

The programme will cover:

• Importance of dissolution and related product design issues
• Current pharmacopeial provisions
• Review of compliance issues
• Suggested methodology for regulators to assess manufacturer compliance
• Current challenges in dissolution method development
• Investigation of out-of-specification results
• A panel discussion for open exchange among speakers and attendees

According to SPDS, the programme aims not only to discuss issues but also to identify corrective and preventive actions from both regulators and manufacturers, with the goal of ensuring consistent quality of drug products for patients.

Speakers scheduled to participate include Dr H G Koshia (FDA Commissioner – Gujarat), Dr Pawan Kumar Saini (IPC), Dr Parizad Elchidana (Principal Technical Consultant – Pharma, ACG World), Vijay Kshirsagar, Pearl Pereira Nambiar (Founder – RegXpert Pro), and Rajendra Dadhich (Senior Vice President – Corporate Quality, IPCA). Additionally, Suhas Yewale (Associate Director – Techno Commercial, SOTAX India) will demonstrate the use and control of various dissolution apparatus and explain practical considerations for ensuring accurate results.