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Five Key Indian Trial Regulation Play-Outs For 2016

 
• By Anju Ghangurde

India's clinical trial approval numbers may still be well short of the heady years of 2010-12, but the implementation of a set of crucial trial-related regulations and potential tweaks in others are expected to help bring some momentum back to the sector in 2016.

Top officials of the Indian Society for Clinical Research (ISCR), whose members include several large multinational firms and clinical research organizations, have highlighted the responsiveness of the Indian regulator and government towards facilitating quality clinical trials – the only way new treatments options can be made available to Indian patients at the earliest.

"There is lot of positive intent which has been communicated in all the interfaces that we had with the regulator and bureaucrats – the last such interface as recent as Dec. 23 [2015]," Dr

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• By Anju Ghangurde

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.