India Streamlines Regulations for Clinical Trials

International companies conducting multinational trials may find it easier to sign up Indian sites due to improvements in the country’s regulatory structure. Laws in India used to stipulate that in multinational trials, research at the Indian site had to be one phase behind sites elsewhere, but this lag has been abolished, Munish Mehra, managing director at Global Drug Development Experts, said. The Drugs Controller General of India, which consists of a small group of regulators, makes no regulatory distinction between clinical trials of drugs and devices. “Most devices are not regulated,” Mehra noted. “Only a few need regulatory approval.”