HYDERABAD: Following the incidents of pharmaceutical companies indulging in malpractices in conducting clinical trials on humans in 2011 in Hyderabad, the National Human Rights Commission (NHRC) has come out with guidelines on conducting clinical trial of drugs. The NHRC had constituted an expert committee in drug regulation and clinical trials which has come up with several recommendations.
The first thing the committee pointed out was that subjects who were normal healthy persons and who participated in the bioavailability/bioequivalence study in the Hyderabad incident were not given proper information on the risks involved in the study and were also exploited for money. The participants were also not provided proper medical care for subsequent side-effects.
One of the main recommendations of the NHRC committee is that ethics committee should be set up in all institutions undertaking studies on human subjects and should be registered under the Drugs and Cosmetics Act and Rules. A standard Operating Procedure (SOP) should be followed in all clinical trials/clinical studies, based on the prevailing good clinical practices (GCP) guidelines issued by the Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR).
While setting up an ethics committee is a must, making the members aware of the provisions of various Acts is also necessary, the NHRC said. For the purpose, it was recommended that regional/state training centres be set up where a common minimum syllabus would be covered in a course on ethical guidelines.
"Informed consent procedure should be standardized and simplified. Information given to patient should include details of risks involved. It should also inform about the rights of participants for compensation in case of injury or death during the study as per the provisions of the Act, regulations and rules," the NHRC said.
It will not suffice if pharmaceutical companies take the written consent of persons who are illiterate. An audio-video CD by the investigator should be shown to participants for their knowledge about the study. There should also be proof of them having seen it.
The procedure for recruitment of participants/volunteers for the trial should be documented and participants should be provided medical care from the time of enrollment in the study.
It may be mentioned here that several people who were subjects in clinical trials of drugs conducted on humans in Guntur district by a Hyderabad-based pharmaceutical company had to be hospitalized due to various complications. The NHRC responded immediately and sent a two-member team to speak to victims directly and come to a conclusion about what went wrong.
Several instances of deaths have been reported from other parts of the country during clinical trials. In fact, the parliament was informed that 436 people died during clinical trials in the country in 2012. In 2011, as many as 438 people had died and in the year 2010 there were as many as 668 deaths due to clinical trials.