Jaipur: Twenty one people in Rajasthan’s Churu district had to be admitted to a hospital after a foreign pharmaceutical company allegedly tested drugs on them. The drugs were not cleared for human testing and were meant to be tested on animals, preliminary investigation has revealed.
Those who were drug-tested are labourers from Bidasar and nearby villages in Churu. A victim told News18 that the company had paid Rs 500 per person in exchange for participating in the illegal drug trial.
They were administered the drug on March 19, following which their health worsened.
State health minister Kali Kadam Saraf has ordered a probe into the case. He described it as a serious matter and said that he has instructed the principal secretary of medical health to investigate it. “We will take strong action against those responsible for it,” said the health minister to news agencies.
As per rules, any trial of a new drug has to be first done on animals. It is done to understand the safety and proper dosages of new medicines and treatments before clinical trials on humans can be held.
It is an expensive step for drug companies who must prove to regulatory authorities that treatments have no dangerous side-effects in order to bring them to market.
According to a report by the Confederation of Indian Industry, companies save up to 60 percent by undertaking the different phases of testing a new drug in India as compared to developed countries.
As per the law, the subject of a trial or his family must be given copies of the patient information sheet, consent form and a clinical trial liability insurance policy. Clinical trials can be done only if the patient is ready.
For clinical trials, the hospital has to get permission from the clinical ethical committee first. There are supposed to be nine people, including doctors, lawyers, social workers in the committee.
Also, if a person is to be tried, he should be a patient related to that disease. Before the trial, the doctor, the company's officer has to give the patient all the information about that medicine.