Annoyed by the non-submission of reports with regard to unauthorised clinical drug trials in Andhra Pradesh, the National Human Rights Commission on Monday asked the health ministry and state officials to respond within six weeks or face action under law. The commission had sent notices to the Union health secretary, secretary of the Indian Council of Medical Research, Drug Controller General of India and Andhra Pradesh chief secretary last year, asking them to file reports with regard to unauthorised drug trials on six women in the state.
About three dozen women in Guntur district were subjected to clinical trials apparently for breast cancer, during June last year. Six of them were hospitalised after they complained of side-effects like severe headache, fever, pain in the chest and nausea. The women were hired through local agents and they were never informed about the medicines they were administered with. The police registered a case against the pharma company, but could not proceed with the case since the women had “volunteered” to take part the trials. Andhra Pradesh leads clinical trials in the country with a number of pharma companies and hospitals involved in research. Though they are required to be registered with the Clinical Trials Registry of India, many carry on research without prior approval from the CTRI.