Says respond else face action
Annoyed by the non-submission of reports regarding illegal clinical trials of breast cancer drug, the National Human Rights Commission (NHRC) has issued notices to the Union health ministry and the Andhra Pradesh government. It has asked the Centre and the state government to respond within six weeks or face action.
The commission had in June last year sent notices to the Union health secretary, secretary of the Indian Council of Medical Research (ICMR), Drugs Controller General of India (DCGI) and Andhra Pradesh chief secretary in connection with the incident. Illiterate poor women from Piduguralla town in Guntur district were hospitalised after a drug trial by Hyderabad-based Axis Clinical Laboratory, a contract research organisation (CRO) on June 17, 2011. The trial was for testing the effectiveness of the breast cancer drug Exemestane in Indian conditions. The drug is manufactured by US pharma giant Pfizer, and is sold under trade name Aromasin in the US.
Hyderabad, the pharma capital of the country, is emerging as a clinical trial hub. Surrounded by backward districts with high levels of poverty and illiteracy the region has no dearth of volunteers and patients for clinical tests. As per the Clinical Trial Registry of India, the state accounts for 40 per cent of the trials in India. Apart from hospitals, there are 10 CROs in the state—nine are in Hyderabad—which conduct trials.
In the wake of the Piduguralla incident, the NHRC had asked the state health secretary to properly assess the health condition of the villagers and ensure suitable compensation for the victims. It had also asked the Central Drug Standard Control Organisation (CDSCO) to conduct a proper study in different parts of the country to ensure that the guidelines on clinical drug trials were not violated.
Following the incident the DCGI had ordered an investigation into the operations of all CROs in the state in June last year. Preliminary investigation had shown that Axis Clinical Laboratory had violated all procedural codes and the ethics committee of the CRO, which should monitor all the drug trials, failed to function independently. The Drug Controller General of Andhra Pradesh had ordered to close down the CRO’s bioequivalent study centre in Miyapur. It also ordered to investigate into all the drug trials done by Axis in the two months prior to the incident.
The Piduguralla incident happened even before the dust settled on the clinical trial for a cervical cancer vaccine in Khammam district last year. Six tribal girls had died during that trial.
On not receiving any reports from the Central and state authorities, the commission again on September 26 and December 15 sent reminders. But the authorities again failed to respond. The only communication the commission received was from the DCGI dated July 7, 2011, which simply stated that all the drug trials were required to be conducted as per Good Clinical Practices (GCP) guidelines issued by the CDSCO, says an official statement released by the commission.
The release points out that the DCGI neither responded to the specific issues raised by the commission in its notices nor it submitted the GCP guidelines along with its communication.
The commission has now asked the Central and state authorities to submit the reports within six weeks. If they fail, NHRC may invoke the provisions contained in Section 13 of the Protection of Human Rights Act, 1993, says an official statement released by the commission.
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