Indian Court Wants Stricter Clinical Trial Oversight

Amid ongoing concern over the conduct of clinical trials in India and patient protection, the Indian Supreme Court has slammed regulators for shoddy oversight that is creating “havoc” and leading to the deaths of many citizens. In sharp remarks, the government was criticized for going into a “deep slumber” and failing to establish mechanisms to stop “rackets” of multinational drugmakers, which are allegedly conducting illegal clinical trials around the country, according to various media reports (see here and here). “There has to be some sense of responsibility (on the part of the government). Human beings are being treated as guinea pigs. This is unfortunate,” the justices said, according to NDTV. “…There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far.” The comments were made during a hearing on a petition submitted by doctors and the non-profit organisation Swasthya Adhikar Manch, which claimed that citizens in the Madhya Pradesh region had been involved in drug trials without their permission The regional government has argued that states cannot be blamed because permissions for trials were granted by the central government without consultation, PM Live writes. The court also acknowledged another petition that accused GlaxoSmithKline of failing to provide proper treatment to some of the 24,000 tribal girls in two states who were given its HPV vaccine in ...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Clinical Trials GlaxoSmithKline HPV India Vaccines Source Type: blogs