Indian pharma requires to install Regulatory Intelligence to remain competitive in market: Expert
Indian pharma industry will now require to install Regulatory Intelligence (RI) solution to ensure faster access to market and gain a share in an competitive environment, said Siddharth H Shah, associate director, Regulatory Affairs Lead, R&D Practice, Life Sciences, Cognizant.
“Regulatory Intelligence provides better competitive strategy to win and sustain market share, create brand value, ensure better relationship with Health Authorities (HA) and remain regulatory compliant. There is a major transformation in drug manufacturing and marketing approvals globally with prevalence of strict norms,” he added.
Shah who was addressing at the DIA event said that only Regulatory Intelligence was the future and its adoption was core for the development of pharma companies regulatory adherence.
Stating current approach to Regulatory Intelligence has its limitations, Shah highlighted with a few examples where if a generics company wanted to develop a product to be launched in the US, it would need extensive information about that market before it embarked for a successful product launch. Now the company would also require how to approach from regulatory affairs perspective, he said.
Current approach to RI is that allows access to external and internal databases to gather data. But there are several limitations to this as most of current external database captures around 70 countries data only, while top 10 multinational companies does business in average 106 countries. Now the user will have to access external and internal data separately. Majority of the external RI databases is seen to be limited in terms of advanced search capability, said Shah.
There is also the challenge of having too much or too little data made available to business users. The manual and laborious public domain data search and data management is also an issue.
Business user needs to store documents in separate document management system. There are also problems to share and collaborate with external or internal stakeholders. There is need for multiple applications required to meet typical business tasks. All this calls for requirement of new solution approaches like optimize the value of existing RI data, bring relevant processes under one roof with appropriate access control and reduce dependency on people, he said.
There is need to look at clear advantages of RI which performs all tasks within the same system. The RI technology should capture data for all countries that a company operates and in all formats required by end users. It should provide capability to manage business user’s group specific documents. Further, it should offer the query management capability to business users for expert summaries and clarifications besides on demand ad-hoc reports.
