Switzerland: Pharmaceutical company Novartis to investigate India's drug approval process
Novartis is to investigate India's drug approval process after an Indian parliamentary report found that the country's regulator had colluded with pharmaceutical firms to speed up approval procedures. The most striking allegation in the report, that followed the investigation, is that that the country’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), has been colluding with pharmaceutical firms to speed up the approval of their drugs. As part of the investigation "the standing Indian upper house committee on health and family welfare reviewed 39 randomly selected drugs approved by the CDSCO, which oversees clinical trials and the country’s 10,000 pharmaceutical firms. In the case of 11 drugs, including Novartis' everolimus and aliskiren, it found that "mandatory" Phase III clinical trials - the final stage of testing before a drug is approved - had not been conducted as required." (New Europe)
Phase III clinical trials are large clinical trials that are conducted once a treatment or drug has been shown to be "efficacious with tolerable side effects" in the preceding Phase I and Phase II clinical trials. Whereas the Phase II clinical trials are conducted on a small cohort of people, in order to limit the number of people who made be affected adversely, Phase III clinical trials are conducted on larger groups of people, often of different ethnicities, as ethnic differences can alter the metabolism, efficacy and safety of a drug. The report stated that "in the case of everolimus, the CDSCO relied on the judgment of non-medical staff rather than seeking the opinion of independent experts, the report said. Novartis said it followed one global ethical standard for conducting clinical trials worldwide and stood behind the safety and efficacy of its products. (New Europe) In particular the committee’s report also criticised the CDSCO for approving thirteen drugs that were banned in the United States, Canada, Britain, Australia and the European Union because of side effects. “There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts,” the report said. “Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk.” (New Europe)
There was also evidence to suggest that pharmaceutical companies were often involved in drafting the recommendations of medical experts, that the CDSCO requires for drug approval, so that all the experts had to do was sign the reports that had been written by so called "invisible hands". "There is plenty of evidence in the report to support this claim. For instance, the report found that recommendations ostensibly drafted by different experts – many of them medicine professors in Indian universities – were “word to word identical.” This was the case for letters submitted by three experts on rivaroxaban, an anti-blood clotting drug produced by Germany’s Bayer AG, which the report said were “merely ditto copies of each other.” The report discovered similar copy-and-paste approaches for clevudine, a drug used to treat hepatitis B produced by Pharmasset Inc., and sertindole, an anti-psychotic manufactured by Denmark’s Lundbeck A/S." (Wall Street Journal/India) The concern is that some of the drugs, that have been through this approval process, may be available for use within the UK and the rest of the EU.
Last Updated (Tuesday, 10 July 2012 09:28)