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Careful intervention and regulatory thought process is required to accept novel techniques in pharma and biotechnology sector, stressed Dr Jayaprakah Narayana, an expert in regulatory affairs, who was the chief guest at the recently held international pharmaceutical regulatory affairs conference in Hyderabad.
Stressing on the need for efficacy, safety and cost effectiveness in the field of pharma, Dr Narayana opined that careful intervention and regulatory thought process is required to accept a novel technique today. The two-day 2nd international conference of pharmaceutical regulatory affairs was organised by OMICS Group bringing together renowned scientists from around the world to discuss new technologies and emerging trends to Indian pharma industry and academia. The two-day congress had 24 sessions with about 150 lectures and 300 poster presentations.
Sources informed that there were 15 invited lectures by resource persons from industry, academic and regulatory agencies. More than 700 delegates from more than 25 countries had participated at the conference.
Eminent personalities who spoke in the event include Dr Prakash Nagara Katti, president-research, University of South Carolina, USA; Prof. Patrik Leoni, Euromed management, France; Prof. Jagath R Kanver, director-research council, Dekin University, Australia; and Dr Michael Alexender, director-MIDI Inc., USA. The topics which were highlighted include regulatory affairs for healthcare products, safety and quality recognition, business law enforcement, regulatory compliances in healthcare, novel strategies for growth in the pharma and regulatory environment and biomedical intellectual property management.
Giving insights into various issues relating to vaccines and related diseases, Dr Narayana stressed that regulations in pharma industry should be evolved by blending the past experiences to overcome the future challenges pertaining to the industry. “A century ago we had very little knowledge to share about the budding technologies of that period such as vaccines, recombination etc., but today history left us with valuable experiences where a technology can be a pro or a con,” said Dr Narayana.
Companies are carrying a great hope along with an intense fear in the process of drug discovery and it is proved that a failure at any step can be a huge setback not for the drug alone but in the old economic status of an organization. Higher cost does not bring higher benefits, opined Dr Narayana. He also said that exhausted fear developed by the surrounding media is playing a role before companies think about novel technology. He suggested critical testing is very important in a country like India but we need to avoid fear to consider the long term gains in the pharma sector. Short term benefits of few individuals like physicians, industrialists shouldn’t undermine the long term benefits of the common man, he added.
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