FDC Ban – a well-intended but overdone development

Sathguru’s healthcare practice lead Pushpa Vijayaraghavan’s and Senior Consultant Shree Divyya’s opinion on the recent ban on 343 Fixed Dose Combinations (FDCs) in India – in Biospectrum’s September 2018 edition.

Our experts conclude:
‘From a consumer perspective, it is encouraging to see proactive regulatory action in the interest of patient safety and benefit. However, with blanket decisions underlined by redundancy in action, patients could be denied access to convenient choices that citizens in several other countries continue to have. If OTC drugs available in several other countries are banned in India and no clear regulatory pathway is created for OTC drugs in India, both industry and consumers stand to lose. Most importantly, a regulatory environment that is not industry friendly could threaten domestic self-sufficiency in the longer term, and the Indian patients should be most insecure about this implication. To ensure such casualties don’t repeat in the future, it is also important that we urgently bridge regulatory gaps and points of ambiguity – especially with creation of a globally comparable OTC pathway. The patient should continue to be at the heart of every regulatory decision – but with greater understanding of implications for today, tomorrow and the longer term.’

Source: Biospectrum’s September 2018 edition

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