Clinical trial volunteers complain NHRC on irregularities, exploiting ignorant trial subjects

A Raju, HyderabadThursday, August 11, 2016, 08:00 Hrs  [IST]

A group of clinical trial volunteers from Andhra Pradesh and Telangana State have approached the National Human Rights Commission (NHRC) complaining against some of the clinical research organizations (CROs) and laboratories conducting investigative drug trials on subjects by violating certain regulations and exploiting the subjects.

In an appeal to the NHRC last week, a group of volunteers headed by M S Swamy Choudary of Hyderabad and Shaik Sabir Ali of Jammikunta in Karimnagar have approached the NHRC to intervene and investigate into the irregularities by the clinical trial laboratories and CROs in both the states of Telangana and Andhra Pradesh.

According to statistics there are close to two lakh volunteers in TS and AP who offered themselves for clinical trials to about nine research organizations (labs) such as Axis Lab, Vimta Labs, QPS Bioserve India, CR Bhayo Labs, Actimas Lab, Sipra Lab, Clinsion Lab, Agent Lab and Yanclor Labs. Out of these nine labs except Actimas Lab, all the other clinical trial laboratories are located in Telangana surrounding the city of Hyderabad.

As per an estimate there are about 10-15 thousand volunteers from each district in both the states who offer themselves as subjects of clinical trials. However, majority of these subjects are either ignorant or suffering from some ailment and they offer themselves in the hope that they will get a cure for their disease.

Taking this as an advantage, many labs are conducting drug research trials on these gullible subjects and exploiting them by not paying them proper compensation or not giving them full information about what drug is being tested on them and what is its side effects.

It is alleged that majority of the clinical trial labs are not following the set guidelines and resorting to violations by conducting clinical trials every month while they are supposed to conduct them only once in three months.

In fact only finger prints of thumb and index figure are to be taken from the subjects during appointing them for clinical trials, but instead they lab authorities are recording finger prints of all the 10 fingers so that they could tamper investigation. The informed consent form (ICF) is not provided to the donors or subjects and are kept in the dark and the mobile phones are also seized from the subjects before starting clinical trials and they are not allowed to even contact their family members.

“At present, about 700-1000 people are undergoing clinical trials but no ethical committee members are present during the selection of the subjects. Since the mobile phones are seized they cannot contact anybody. Sometimes one has to stay at the lab for 72 hours to 15 days depending on the drug. Also a copy of the ICF is never given to the volunteers and most of them do not know about the consent form and its contents,” informed Shaik Sabir Ali.

However, the clinical trial companies are of the view that they are following all the set of regulatory norms by the government and all their operations are being conducted at global standards.