Regulators from the Central Drugs Standard Control Organization (CDSCO), Food and Drugs Administration (FDA) Haryana, the Drug Control Department Delhi, and pharmaceutical stakeholders from across India, especially from Haryana gathered in Sonipat Haryana, on April 26, 2025, for a groundbreaking symposium on “Dissolution Science and Drug Development”. This important event, held at Rishihood University, Sonipat, was a collaborative effort by the All India Pharmaceutical Associations Consortium (AIPAC) in collaboration with the prominent regulatory bodies and industry associations. The impressive list of organizers included the Food and Drugs Administration (FDA) Haryana, the Haryana Pharmaceutical Manufacturers Association (HPMA), the Indian Pharmacopoeia Commission (IPC), the Society for Pharmaceutical Dissolution Science (SPDS), the National Institute of Pharmaceutical Education and Research (NIPER Mohali) and the Indian Drugs Manufacturers Association (IDMA). The symposium served as a vital platform, bringing together regulators, seasoned industry experts, and leading academics. The primary focus was to foster in-depth discussions on the latest innovations and persistent challenges within the realm of dissolution science, an important issue of the pharma sector. Understanding how drugs dissolve in the body is paramount for ensuring their efficacy and safety, making this field critical for drug development and quality assurance. The event commenced with a warm welcome address by R L Sharma, the president of HPMA. The chief guest for the symposium was Dr Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI). His keynote speech emphasized the implementation of the revised Schedule M. He emphasized the need for adherence to updated good manufacturing practices. The symposium was chaired by Manmohan Taneja, the drugs controller of Haryana, whose leadership ensured a focused and productive exchange of ideas for the betterment of the pharma industry. Kamal Ranjan Chawla, the controlling and licensing authority (SLA) for the NCT of Delhi graced the occasion as the guest of honour. Key topics that were thoroughly examined included innovations in dissolution apparatus, regulatory concerns, BCS classification, formulation challenges, tablet dissolution issues, pharma digitisation, revised Schedule M and a panel discussion. Suhas Yewale, associate director at SOTAX India Pvt Ltd, illuminated the increasing adoption of advanced dissolution apparatus compliant with Indian Pharmacopoeia standards. He also highlighted new technologies and their impact on dissolution testing. Vijay Kshirsagar, director and CEO of TRAC Pharma Consulting, highlighted the indispensable role of dissolution studies in ensuring drugs meet required regulatory requirements. Prof Sanyog Jain from NIPER Mohali provided valuable insights into how dissolution behaviour fundamentally defines the Biopharmaceutics Classification System (BCS) categories. Prof Saranjit Singh from NIPER discussed in length about complex formulation challenges, including the issue of gelatine cross-linking which can be an obstacle for the proper dissolution of capsules. Sudeep Ojha from Zydus Lifesciences Ltd discussed about the “coning” effect, a specific issue occurred during dissolution testing that can affect the results. Raveendranath Govindaraj, founder of Lab Iconics Technologies LLP, highlighted automation in pharmaceutical laboratories, emphasizing its importance to enhance efficiency and ensure strict regulatory compliance. R.K. Harna, ASDC (Retd.) from FDA Haryana, outlined the important updates and key points within the revised Schedule M, providing clarity on the implementation. The interactive panel discussion was moderated by Dr. Rajiv Desai, senior technical advisor at IPA.
|