Last Updated on May 5, 2025 by The Health Master
Symposium
Sonepat, Haryana – 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 Sonepat, Haryana, on April 26, 2025, for a groundbreaking “Symposium on Dissolution Science and Drug Development.”
This important event, held at Rishihood University, Sonepat, 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 & Research (NIPER-SAS Nagar), and the Indian Drugs Manufacturers Association (IDMA)
Experts to Advance Pharmaceutical Excellence
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.
Keynote Address
The event commenced with a warm welcome address by R. L. Sharma, the President of HPMA.
The chief guest for the symposium was none other than Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), a top regulator of India.
His keynote speech emphasized the implementation of the revised Schedule M.
He also emphasized the need for adherence to updated good manufacturing practices.
The symposium was expertly chaired by Manmohan Taneja, the State Drugs Controller for FDA 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 for the NCT of Delhi, graced the occasion as the Guest of Honor.
Dissolution Science
The one-day symposium featured a well-planned agenda, commencing with the inauguration ceremony at 9:30 AM, followed by a series of important technical sessions and engaging panel discussions on the gap analysis for revised schedule M.
Key topics that were thoroughly examined included
Innovations in Dissolution Apparatus:
Suhas Yewale, Associate Director at SOTAX India Pvt Ltd, illuminated the increasing adoption of advanced dissolution apparatus compliant with Indian Phamacopoeia standards. He also highlighted new technologies and their impact on dissolution testing.
Regulatory Concerns:
Vijay Kshirsagar, Director & CEO of TRAC Pharma Consulting, highlighted the indispensable role of dissolution studies in ensuring drugs meet required regulatory requirements.
BCS Classification:
Prof. Sanyog Jain from NIPER-SAS Nagar provided valuable insights into how dissolution behavior fundamentally defines the Biopharmaceutics Classification System (BCS) categories.
Formulation challenges:
Prof. Saranjit Singh, an Ex-Professor at NIPER, discussed in length about complex formulation challenges, including the issue of gelatin cross-linking, which can be a obstcle for the proper dissolution of capsules.
Tablet Dissolution Issues:
Sudeep Ojha from Zydus Lifesciences Ltd. discussed about the “coning” effect, a specific issue occured during dissolution testing that can affect the results.
Pharma Digitalization:
Raveendranath Govindaraj, Founder of Lab Iconics Technologies LLP, highlighted automation in pharmaceutical laboratories, emphasizing its importance to enhance efficiency and ensure strict regulatory compliance.
Revised Schedule M:
R.K. Harna, ASDC (Retd.) FDA Haryana, outlined the important updates and key points within the revised Schedule M, providing clarity on the implementation.
Panel Discussion
Interactive panel discussion moderated by Dr. Rajiv Desai, Senior Technical Advisor at IPA.
The esteemed panel comprised:
Kamal Ranjan Chawla, Controling and Licensing Authority, NCT of Delhi), who provided detailed analysis of the gap assessment required for the implementation of the revised Schedule M.
Dr. Ajay Sachan, DDC(I), CDSCO North Zone), who highlighted the most significant aspects of the revised Schedule M.
R.K. Harna (ASDC (Retd.) FDA Haryana), who further elaborated on the intricacies of the revised Schedule M.
Rakesh Dahiya, SDCO cum Licensing Authority, Sonepat Zone, FDA Haryana, and the Symposium’s Organizing Secretary, who discussed the importance and practical implementation strategies for the revised Schedule M within the pharmaceutical industry.
He also addressed the very important issue of Not of Standard Quality (NSQ) samples, focusing on root cause analysis (RCA) and corrective and preventive action (CAPA) methodologies.
Lalit Kr. Goel (Dy SDC FDA Haryana), who pinpointed the specific changes introduced in the new revised Schedule M.
Manmohan Taneja (SDC FDA Haryana and Chairman of the Symposium), who reiterated the paramount importance of adhering to the revised Schedule M guidelines.
Also read: NSQ Drug: Route cause analysis and CAPA
A Collaborative Spirit
The symposium served as a powerful demonstration of the collaborative spirit within the Indian pharmaceutical ecosystem.
The active participation of FDA officers, owners of manufacturing units, and technical staff, including QA personnel and analytical chemists from various pharmaceutical companies, showed the collective commitment to dissolution science, advancing drug quality, and regulatory compliance within the pharma industry.
Dedicated Organizers and Esteemed Guests
The successful execution of the symposium was attributed to the dedicated efforts of the members of the organizing committee of the event:
- Manmohan Taneja, SDC, FDA Haryana and Chairman of the Symposium.
- Rakesh Dahiya, SDCO cum Licensing Authority, Sonepat Zone, FDA Haryana and Organizing Secretary of the Symposium.
- Vikas Pruthi, Secretary of HPMA and Organizing Associate of the Symposium.
- Sandeep Hooda, DCO Sonepat and Organizing Associate of the Symposium.
- Munshi Ram, DCO Sonepat and Organizing Associate of the Symposium.
The event was further graced by the presence of several special guests from the FDA, including
- Ripan Mehta (ASDC),
- Parjinder Singh (ASDC),
- Krishan Garg (SDCO),
- Gurcharan Singh (SDCO),
- Suresh Chaudhary (DCO),
- Vijay Raje (DCO),
- Sandeep Gahlain (DCO),
- Ritu Mehla (DCO),
- Vikas Rathee (DCO),
- Parveen Rathi (DCO) and
- Vishal Sachan, DI, Delhi.
The event was also graced by the presence of several special guests from the HPMA, including
- Sanjeev Vaid, Treasurer,
- Rajeev Aggarwal, Sr. Vice President and
- Yogesh Midha, Vice President).
And the following executive members of the HPMA:
- Pavel Garg,
- Rajeev Goel,
- Rajeev Garg,
- Sanjay Arora,
- Sanjay Manocha,
- Vineet Gupta,
- Narender Arora,
- Rohit Gupta, and
- Rajesh Chawla
The symposium concluded with a vote of thanks delivered by Vikas Pruthi, the General Secretary of HPMA, acknowledging the contributions of all participants and organizers in making the event a grand success.
Q. What was the primary focus of the Symposium held in Haryana?
A. The symposium primarily focused on discussing innovations and challenges in dissolution science and drug development and implementation of the revised Schedule M for the pharmaceutical industry.
Q. What is the importance of dissolution science in the pharmaceutical industry?
A. Dissolution science is very important for understanding how drugs dissolve in the body, which directly affects their absorption, efficacy, and overall quality.
Q. What is Revised Schedule M?
A. Revised Schedule M refers to updated guidelines for Good Manufacturing Practices (GMP) in the pharmaceutical industry in India
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Gist of 31 Chapters on Schedule M
Revised Schedule M Guidelines: Drug Recall and Ensuring Pharma Quality
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Revised Schedule M: The Role of Pharmaceutical Waste Management
Gap analysis for Revised Schedule M
Important short notes for Industry and Regulators
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