martes, 22 de noviembre de 2011

BRIC´s: Investigación clínica "bajo sospecha".

Indian authorities have claimed they plan to tighten regulations over the way medical trials are conducted in the country and address some of the concerns highlighted in The Independent's investigation.

As campaigners in India and around the world repeated their call for better oversight, official sources admitted that weak regulation was a problem that needed to be tackled by the Drug Controller General of India (DGCI), the body charged with overseeing and regulating trials.


Europe: MEPs target companies using 'guinea pigs' overseas

An influential group of MEPs have vowed to stamp out unethical clinical trials by forcing European regulators to take more robust action against drug companies guilty of violations.

The MEPs are urging a key European committee to hold emergency discussions amid growing evidence of ethical abuses in developing countries. The European Medicines Authority (EMA) has been accused of failing to enforce existing laws that stipulate only drugs tested ethically, to international standards, should be licensed in Europe.

The EMA, responsible for approving new drugs in Europe, told The Independent that the globalisation of clinical trials posed a "huge challenge" that needed more resources and better cooperation from the pharmaceutical industry.


Brazil, like India, has recently relaxed regulatory systems to speed up the approval of clinical trials, allowing CROs to operate without accreditation – registration with the chamber of commerce is enough to start testing drugs on humans. At least 26 CROs operate in Brazil, mostly in Sao Paulo, including eight of the top 10 multinationals.

Independent oversight by regulatory authorities and ethics committees in Brazil "leaves a lot to be desired", the NGO Somo has warned.

Y, si fuera pagan las "consecuencias".

A Union health ministry probe has revealed that pharmaceutical majors conducting clinical trials in India have not given compensation to majority of the volunteers who died during the trials. Of the 671 deaths that were reported in 2010, the ministry has evidence of just three cases of compensation.

The ministry has asked 44 pharmaceutical companies, including global drug majors such as Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi Aventis, to explain why they have not given the compensation, which is mandatory under the current drug laws.

A Novartis spokesperson said the clinical trial investigator (who conducted the trial for Novartis) had asserted the deaths were not because of the study medication but due to progression of underlying disease (which won’t necessitate compensation).
Similar arguments were made by most pharmaceutical firms that figured in the list. (Ver)

Ver también:

USA: Preocupa el "off-shoring" en investigación clínica

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