India waives clinical trials for drugs approved elsewhere
India has waived a requirement that pharmaceutical companies conduct local clinical trials before they’re approved for marketing in the country, if those drugs have been approved in select other countries. The move will fast-track approvals and benefit patients, India’s government says. The New Drugs and Clinical Trials Rules, released last month, allows drugs to be approved in India if they’re already approved in the US, UK, EU, Japan, or Australia. Previously, it took three to six months to get a drug approved in India. The new rules will reduce that time to one month for drugs manufactured in India and three months for those made elsewhere. The clinical trial waiver will also extend to drugs that receive marketing approval elsewhere while a trial is underway in India. The new regulation also includes provisions for compensation for clinical trial participants who suffer death, permanent disability, or injury as a result of a trial. The Indian Society for Clinical Res...