Updated on 17 August 2012
In case of three other drugs where clinical trials were carried out, they were not in line with the required 100 patients on three-to-four trial sites. For this, the CDCSO said the trials were carried out in cosmopolitan cities, and hence presented sufficient diversity among the said patient population. A closer look at the location of the trials, however, revealed that they had been carried out in cities like Kota, Aurangabad, Bhopal and Vadodara that cannot exactly be defined as cosmopolitan. In some cases, these trials were carried out entirely by private practitioners. All these factors begged to raise the question if the trials were being carried out just for the sake of documentation.
Additionally, 13 drugs that were approved by the CDCSO were such that they are currently not approved for sale in any major developed countries, such as Canada, the US, Australia and the European Union. Even more surprising were examples of drugs such as Buclizine approved in 2006 for appetite stimulation in children without clinical trial or expert opinion. The drug developed in Belgium is not approved for the condition, appetite stimulation, even in its innovator country. The standing committee has sought a review of this approval.
In the case of four other drugs, neither the opinion of any expert was sought nor any clinical trials were conducted, but the decision for approving the drugs, as the report puts it, was "by the non-medical staff of CDSCO on their own".
The slew of reputed MNC pharma companies indicted in the report have raised pertinent questions on the approval system. In response to the allegation that their drug Ambrisentan was approved without mandatory trials, the spokesperson said the "drug was approved in Europe in 2008 and in the US in 2007 after evaluating 400 patients in two pivotal phase III studies. This complete global clinical data set was submitted by GSK to regulatory authorities in India in 2009 and since PAH (pulmonary arterial hypertension) is a rare disease which is life threatening and debilitating, GSK was granted a local clinical trial waiver in India".
Others such as Cipla have previously stated that "they have followed all the necessary regulations for the approval of their drugs".