Some text from 59th Report of Parliamentary Standing Committee on Health and Family Welfare. Presented in Rajya Sabha on 8th May 2012. Approval of New Drugs Briefly the statutory rules require that apart from submitting specified documentation (pharmacology, toxicology, animal studies, overseas clinical trials etc.), the applicant for New Drugs discovered outside India should conduct Phase-III trials on not less than 100 PATIENTS at 3-4 different hospitals in India to test the efficacy and safety of new drugs for proposed indication.
In order to scrutinize new drug approvals, the Committee sought details in respect of randomly selected 42 medicines from the list of new drugs uploaded by CDSCO on its website. Out of 42 drugs picked up randomly for scrutiny, the Ministry could not provide any documents on three drugs (pefloxacin, lomefloxacin and sparfloxacin) on the grounds that files…
