Does India's Perpetual Licensing Plan Risk Backfiring?
India's wide-ranging drug regulation overhaul plan, including a perpetual licensing system aimed at simplifying processes and potentially delinking licensing and enforcement responsibilities may well emerge as a double-edged sword.
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Health authorities have been working for years toward ensuring the safety of medicines in the global supply chain, and India - one of the biggest providers of inexpensive generics worldwide - has been a key focus. But while the incidence of substandard medicines in the country has fallen, it still hovers at around 4-5% of supplies, according to the country’s drug regulator, which is proposing new steps.
A key Indian advisory panel is expected to consider a crucial tweak to certain regulations pertaining to the approval of “new drugs”, which domestic firms allege could facilitate a different form of data exclusivity and also limit competition.
The 50th annual general meeting of the Organization of Pharmaceutical Producers of India (OPPI) in Mumbai saw an eclectic mix of leaders from academia, politics, bureaucracy and industry in full attendance. Abbott's bullishness on the Indian market and suggestions for concerted efforts to move the access needle were among the key takeaways of the event.