Experts deliberate importance of industry, regulatory agencies collaboration to ensure safety of pharmaceutical products

From time to time, it’s important to understand the Regulatory Perspectives in Pharmaceuticals. Why so? It’s because regulatory perspectives provide an understanding of the regulations and guidelines set by regulatory authorities for the development, manufacturing, and distribution of drugs. Compliance with these regulations is essential for ensuring the safety, efficacy, and quality of pharmaceutical products. Therefore, a thorough knowledge of regulatory perspectives is necessary for professionals working in the pharmaceutical industry to ensure the successful launch and commercialisation of new drugs while complying with regulatory requirements.

To discuss the same,  School of Pharmaceutical Sciences (SPS) at Apeejay Stya University (ASU),Gurugram recently organised a seminar on ‘Regulatory Perspectives in Pharmaceuticals’. This one-day seminar was organsied in collaboration with Indian Pharmaceutical Association (IPA), Delhi State Branch and Walter Bushnell, one of India’s most renowned pharmaceutical companies with a 100+ years legacy of quality & trust. 

The seminar aimed to provide insights into the regulatory affairs of the pharmaceutical industry in India and the United States and IPR regulations.  

Welcoming the key guests, Prof. Anupama Diwan, Dean at SPS, emphasised on the importance of staying up-to-date with the regulatory environment to ensure that the industry produces safe and effective medicines for patients.

As part of the one-day seminar, technical sessions were presented. The first one was presented by Mr. Ajay Verma, Senior Associate Regulatory Operation at Gilead Sciences, New Jersey, US. Mr. Verma provided an overview of regulatory affairs, including the regulatory agencies around the world, regulatory framework, ICH guidelines, the role of regulatory agencies, and the process of drug development and approval. He highlighted, “It’s important to understand regulatory requirements and guidelines for the development and marketing of pharmaceutical products.”

The second technical session was presented by Mr. Amrish Tiwari, Partner,  Patent Attorney at K&S Partners. Mr. Tiwari discussed the basics of IPR and Indian patent system, including the patentability criteria, patent filing and prosecution, and patent infringement. He emphasised, “It is needed to protect the intellectual property rights to promote innovation and commercialisation in the pharmaceutical industry.” 

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The final technical session was presented by Dr. Vishal Wahane, Senior Manager Medical Services at Walter Bushnell Pvt Ltd. Dr. Wahane mentioned, “I would like to highlight the Indian drug regulatory system, including the various regulatory agencies involved in approval of small molecules, biological & biosimilars and medical devices in India.” He also mentioned the approval procedure for orphan drugs in India, while stressing on  the challenges and opportunities in the Indian regulatory environment. “There is a need for collaboration between industry and regulatory agencies to ensure the safety and efficacy of pharmaceutical products.”

All the sessions were interactive with fruitful discussion, in which the experts’ answered questions from the audience and shared their perspectives on current and future regulatory issues in the pharmaceutical industry. Overall, the seminar provided a comprehensive understanding of the regulatory perspectives in the pharmaceutical industry in India and the United States. The insights shared by the experts were valuable for students, researchers, and professionals in the pharmaceutical industry to stay updated with the evolving regulatory environment. 

At the end of the event, an award ceremony was held and the seminar concluded on a high note with an inspiring address by Mr. Kalhan Bazaz, President of the IPA’s Delhi State Branch. Further, the School of Pharmaceutical Sciences at ASU was recognised and honoured for outstanding Academic Delivery and Extraordinary Extracurricular activities by Mr Kalhan Bazaz. Prof. Raj S. Dhankar, Vice Chancellor, Apeejay Stya University and Prof. Anupama Diwan, Dean of the School of Pharmaceutical Sciences, accepted the award on behalf of the School. They expressed  gratitude to the IPA for this recognition. Dr. Diwan highlighted the school’s commitment to providing quality education and research opportunities to students and contributing to the advancement of the pharmaceutical industry in India.