The recent remarks from USFDA to “step-up the quality” among Indian Pharma has come both as a warning an opportunity for the Indian pharma industry. The expectations set by the USFDA officials are in lieu of regulatory requirements that Indian pharma companies should meet right from documentation, publishing, submission, artwork, labeling and filing. Past three years have witnessed over 500 products among top pharma being withdrawn from market due to non-compliance in different forms. The demand for Compliance is high and its time the emerging markets like India catch up to meet the global demands. Where does Indian industry stand? 1- Lack of an internal quality culture: Most companies are deprived of quality-culture within organizations. Definitely cost dynamics will change to some extent, but won’t the cost of non-compliance be in multiples and affect the overall performance of industry? 2- Standardization: Despite many years of operations, many companies work on “ad-hoc” basis. Shouldn’t companies be catching up with standardizing processes like artwork creation/changes, labeling, and documentation by following global guidelines for efficient management and review of ongoing work. In a longer run, this will only save the cost! 3- Automation: Either due to lack of knowledge or ignorance, companies still do not consider automating most of their process whether it is tracking, documentation or any other standardized procedures. Again, isn’t it government’s job too to release directives and mandates that ensure automation is done to improve overall quality? Seems government agencies are too complacent to act proactively before someone else points it out. 4- Allied services like Proof Reading, Documentation, Medical Writing, Artwork/Labeling, automation, technologies and others offer a great opportunity for Pharma companies and budding entrepreneurs alike to create a sustainable ecosystem and not to forget opportunity for thousands of jobs creation. However, most of the action is not surfaced, is it a lack of intent or a larger vision that leads to such inefficient systems? Pharma otherwise is most regulated market compared to other industries, yet there seems to be a lot of catching up to do. Leaders, regulators, entrepreneurs….are you listening?
Posted on: Wed, 07 May 2014 08:10:00 +0000
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