Over 60 civil society organisations from across the world have written to the Director General of WHO demanding revision of the global health body's 'Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)' which were adopted in 2009.
The regulatory framework for approval of SPBs, put in place by many countries, including India, is in accordance with the WHO guidelines, which the groups claim are "unnecessarily cumbersome".
They allege that the "failure" of the WHO secretariat to update the guidelines in line with current scientific evidence and technological advances, "compromises access to affordable biotherapeutic products" and has "grave consequences for the realization of the right to health and the right to enjoy scientific progress."
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