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Seminar on revised Schedule M at JIS University in Kolkata emphasizes urgent GMP compliance in Indian pharma
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Peethaambaran Kunnathoor, Chennai
July 30 , 2025
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In a significant move to address the evolving landscape of pharmaceutical regulations, the Department of Pharmaceutical Technology at JIS University in Kolkata recently organized a national seminar on ‘Industry Perspectives of Drug Regulatory Affairs,’ with a core emphasis on ‘Revised Schedule M Compliance’ for pharmaceutical industries.
The one-day programme served as a crucial platform for dialogue and knowledge exchange between industry stakeholders, regulatory bodies, and academia, highlighting the urgent need for timely implementation of updated Good Manufacturing Practices (GMP) guidelines across India's pharmaceutical manufacturing sector.
A central feature of the seminar was a special panel discussion titled ‘Implementation of Revised Schedule M and GMP Challenges.’ This interactive session brought together regulatory officers from the Central Drugs Standard Control Organization (CDSCO) and the state drug control department, alongside seasoned experts from the industry. The panel effectively addressed numerous doubts and queries raised by both industry participants and regulatory officers, fostering a clearer understanding of the revised guidelines and the practical challenges associated with their adoption.
Dr. Jayanta Chaudhury, the convenor of the program, underscored the seminar's primary objective, which was to educate participants about the changes introduced in the revised Schedule M and to facilitate their timely implementation in manufacturing facilities. He stressed that these updated GMP guidelines are instrumental in enhancing the quality and safety of pharmaceutical products manufactured in India, thereby bolstering consumer confidence and India's standing in the global pharmaceutical market. The discussion particularly emphasized the imperative to expedite conversion activities within production facilities to ensure compliance within the stipulated timeframe.
The panel discussion also provided a forum for addressing specific concerns. Legal queries from industry personnel were expertly handled by Dr. Subhash Mondal, former drug regulator and IPA general secretary, while Arup Chatterjee, deputy drug controller at CDSCO, east zone, clarified technical doubts. Prof. Jayanta Chattopadhyay, from JIS University’s Department of Pharmaceutical Technology, chaired the insightful discussion, which also featured contributions from Soumitra Das, drug inspector, and Dr. Mukti Pada Rana, president of IPA, Bengal Branch.
The seminar attracted a robust participation, with over 200 delegates from academia, including students and scholars, and more than 50 industry representatives from 30 leading pharmaceutical companies. This diverse gathering facilitated rich discussions on evolving drug regulations, the nuances of revised Schedule-M guidelines, global market challenges, and the vital role of industry-academia collaboration. The interactive sessions proved instrumental in enhancing knowledge sharing and fostering a collaborative spirit among experts, regulators, and academics. Prominent participating companies included Mendine Pharmaceuticals, Standard Pharmaceuticals, East India Pharmaceuticals, Palsons Derma, Parker Robinson, and Strassenburg Pharmaceuticals, among others.
The event commenced with a traditional lamp-lighting ceremony by the dignitaries, including Prof. Dr. Bhaskar Gupta (Vice-Chancellor) and other senior academic leaders from JIS University, alongside notable guests of honour Prabhash Bondhu Chakraborty, managing director of Mendine Pharmaceuticals Pvt Ltd, and Birendra K. Sarkar. The inaugural addresses set the thematic tone, with VC Prof. Bhaskar Gupta emphasizing the critical relevance of drug regulatory affairs in modern pharmaceutical sciences for societal progress. Prabhash Bondhu Chakraborty, highlighted the significance of industry-academia partnerships and urged for the upgradation of laboratory instruments to better train students in line with the upcoming revised Schedule M.
In the morning sessions, the seminar featured a keynote lecture on ‘Perspectives in Pharma Regulatory Science’ by Prof. Gautam Ghosh, Pro VC at JIS University, who provided a comprehensive overview of regulatory affairs, global regulatory bodies, harmonization under ICH, and critical aspects of drug development and intellectual property. Furthermore, the technical session, chaired by Prof. Dr. Himangshu Sekhar Maji, dean academics, included presentations by Averi Das Sharma of Fresenius Kabi Oncology Ltd on Drug Master File (DMF) submissions and CTD structure, and Dr. Prafulla Nandy, ex-joint president of Cadila Pharmaceuticals, who delved into the ANDA filing process and career prospects in global regulatory affairs. Alok Ghosh, ex-global president of Lupin Ltd, offered insights into the Indian pharmacy sector's contributions and challenges.
The successful national seminar concluded with a vote of thanks delivered by Prof. Pintu Kumar De (HOD Pharmacy), acknowledging the invaluable contributions of all speakers, industry partners, faculty members, and students in making the program a resounding success. The event undoubtedly served as a vital step in preparing the Indian pharmaceutical industry for the imperative changes brought about by the revised Schedule M, fostering a more compliant and globally competitive manufacturing landscape.
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