Pharmaceutical companies will now be required to prove the efficacy of the drugs on Indian population before selling them to consumers. The Union health ministry is considering to make local clinical trials “mandatory” for all the drugs thereby limiting the waiver of trials to health emergencies and drug indicated for rare diseases. In this regard, a senior official in the health ministry said that, “The health ministry is working on new set of rules for approval of new drugs and clinical trials and also proposed that companies conducting clinical trials will be obliged to provide drugs free of cost to their participants throughout their life, in case the drug proves safe”.
Furthermore, it has been considered to make Phase III trials mandatory in India even if drugs are cleared in developed countries under strict vigilance and safety. “The clinical trials will be waived off only on a…
