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THE MAIN FOCUS
Superior polymer technologies to meet emerging drug delivery demands: Dryenteric coatings Nitin Bhusane Director, Shin-Etsu Chemical Tylose India
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nother technical session at FDD Conclave 2017, covered the topic of dry enteric powder coating and demonstrated how it is one of the superior polymer technologies to meet emerging drug delivery demands. Nitin Bhusane, Director, Shin Etsu Chemical Tylose India, he speaker in this session, gave in-depth information about the use of coating technologies, their need and role in improving the efficacy of the formulations. He also drew a comparative analysis between conventional coating systems
and dry enteric coatings. He highlighted the advantages and disadvantages of different technologies. He also gave details on the application of these technologies in various pharma formulations. Bhusane drew attention to the disadvantages of conventional methods which include low productivity, low polymer concentration, long coating time, difficult to apply to water sensitive drugs and environment pollution. Speaking on the advantage sof dry powder coating, Bhusane said that dry powder coating is high in productivity and solid
content. It will consume less time in comparison to conventional methods. It is easily applicable to water sensitive drugs and there is no harm to the environment in using dry powder coating. Bhusane also gave a detailed pictorial presentation on the right way to apply dry enteric coatings to achieve best results. He further said that his company recommends for dry powder coating to the industry. However, he pointed out that his company has other offerings in the form of powder mixtures and liquid mixtures as well.
Keeping up with evolving regulations Dr BobbyGeorge Vice President & Head Regulatory Affairs, Reliance Life Sciences
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r Bobby George, VP & Head Regulatory Affairs, Reliance Life Sciences, in his session, addressed a vital topic, keeping up with evolving regulations. He also threw light on the government's mandate which involves removing regulatory bottlenecks, enhancing ease of doing business, successfully engaging with stakeholders, etc. Giving a rundown on the current regulatory scenario and the challenges faced by companies in ensuring compliance, Dr George also spoke on
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the measures taken by the government to enable a more effective and transparent regulatory system across pivotal areas such as clinical studies, manufacturing, e-governance, evolving regulations, pharmacovigilance etc. He also examined the effectiveness and efficacy of some significant measures like tightening the noose around irrational FDCs; New Medical Device Rules, 2017; audio video recording of consent, manufacturing test license validity, annual joint inspections of facility, risk-based inspections, establishing and em-
powering Life Science Skill Development Council, reporting of adverse drug reporting (ADRs) for marketed drugs, National Regulatory Assessment by WHO etc. He also analysed the potential of some of the steps on the anvil which includes regulation of online pharmacies; streamlining the process for handling of NSQ samples; amendment of Schedule H list; separate set of rules for New drugs and CTs; setting up mini drug testing labs at port offices etc., to bring in a positive change and create a more efficient ecosystem.
EXPRESS PHARMA
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July 1-15, 2017