In yet another complaint against the unethical drug trials that took
place in the city, a local resident lodged a complaint with the Drug
Controller General of India (DCGI), Medical Council of India (MCI) and
National Human Rights Commission on Saturday accusing some city-based
doctors with a clinic of making his son a trial subject after keeping
him in the dark.
Om Prakash Agrawal, a resident of Rajmohalla
here, alleged that the people involved in the controversial drug trials
kept him in the dark. He alleged that the drug had severe side-effects
and the health condition of his son, Nitin, continued deteriorating.
"After my son failed in examination, his mental health became unstable.
He was not a healthy volunteer. Then, how could the doctors conduct
trial on him," asked Agrawal.
The complainant stated that a medical store owner referred him to Dr
Abhay Paliwal at his clinic in Geeta Bhawan. "Nitin was admitted in May
2010 and we were told that he would be alright in a few days. They
asked me to sign on some forms, which were in English. Though I could
not understand the content, I signed on it trusting the doctors. My son
was admitted to the hospital for 10 days," stated Agrawal in his
complaint.
Informing that the 'treatment' did not yield any
result as per the promise, Agrawal complained that the doctors used to
take blood samples 8-10 times a day.
"We even opposed when doctors collected blood samples frequently but no one listened," alleged Agrawal.
The complaint alleged that an Ahmedabad-based company, Intas, sponsored
the trial for which approval was taken from city-based Naitik
independent ethics committee and ethics committee of CHL-Apollo
Hospital.
Nitin was also not insured against clinical trial
liability and is still taking the medicines for his ailment. He was not
given patient information sheet and a copy of informed consent form, the
complainant added.
However, the doctor involved in the
particular case clarified that no trial was conducted without informing
patient or family member. "I do not remember the case. I have to check
the records. However, no trial was conducted without taking consent of
the patient or family members," added Dr Paliwal.
After my son failed in examination, his mental health became unstable. Then, how could the doctors conduct trial on him.