In a case of illegal drug trial, a man from Indore “discovered” through local newspapers that he was an uninformed guinea-pig for a German drug firm. The newspapers reported the matter after it was raised in the Madhya Pradesh Assembly.
Dhananjay Shrivastava did not know trials of Olodaterol — a drug for respiratory ailments — were conducted on him, till his name figured on the list of 1,112 victims of illegal drug trials made public by the Assembly in response to a question from MLA Bala Bachchan on March 1. His name stood 43rd on the list of 81 cases of Serious Adverse Events (SAEs).
The victim has complained to the Medical Council of India, the Drug Controller-General of India and the National Human Rights Commission for having been made a trial subject without informed consent, and for having paid no compensation for SAEs suffered by him.
The matter was brought to light by the Clinical Trial Victims Association (CTVA) of Madhya Pradesh.
Mr. Shrivastava has alleged that an Indore-based doctor, under the pretext of treating him for tuberculosis, conducted the uninformed and unconsented trial of Olodaterol on him at his clinic, which resulted in SAEs, including a cataract in the right eye, constant headache, nausea and fatigue.
The Clinical Trial Registry of India (CTRI) does not give out the name of the drug and lists it in code as BI 1744 CL for chronic obstructive pulmonary disease (http://ctri.nic.in/Clinicaltrials/advsearch.php). However, the clinical trial registry of the U.S. National Institutes of Health lists the drug as Olodaterol, made by German firm Boehringer Ingelheim, for which trials were conducted in Indore, besides four Indian States (http:// clinicaltrial.gov/ct2/show/NCT00796653?term=olodaterol+ indore&rank=2).
“However, neither the drug company nor principal investigator Salil Bhargava compensated me for the SAEs,” Mr. Shrivastava told The Hindu.
His drug trial protocol card was stapled on the carton of the drug given to him as “free imported medicine.”
According to Schedule Y of the Indian Drugs and Cosmetics Rules, 1945 (third amendment, 2011), it is the responsibility of the pharmaceutical company sponsoring the trial to compensate the victim for any injury during the trial. In the case of a foreign company, the responsibility to compensate the victim is of a local agent appointed by the company of the Contract Research Organisation (CROs) concerned.
In India, Clinical trials of foreign firms are conducted through CROs.
Mr. Shrivastava has also complained that no post-trial assessments were made by the investigator, and no information was given to him or his relatives about the SAEs.