Hindustantimes wants to start sending you push notifications. Click allow to subscribe

Government urged to formulate stringent laws, rules against clinical trials

Hindustan Times, Pune | By
Jan 21, 2019 04:42 PM IST

The ‘National seminar on clinical trials in India- regulations and challenges’ was organised by ILS Law College and supported by Swasthya Adhikar Manch (SAM).

Participants at a seminar on clinical trials have urged the government to come up with stringent laws and rules to prevent illegal clinical trails and protect the rights of patients.

The ‘National seminar on clinical trials in India- regulations and challenges’ was organised by ILS Law College and supported by Swasthya Adhikar Manch (SAM).

Hindustan Times - your fastest source for breaking news! Read now.

Supreme Court advocate Sanjay Parekh and Amitava Guha, national co-convenor, JSA, were among those who participated in the discussion on a range of topics including ethics, regulations, awareness on clinical trials and gaps in government’s draft bill related to clinical trials.

Dattatray Taras recounted how his 63-year-old mother, who is suffering from thyroid became a victim of an illegal clinical trial.

He said: “In 2012, a doctor from Chinchwad gave us a medicine which was not prescribed and said it would help my mother in her health problems. On seeing the strip, I saw that the drug clearly mentioned ‘sample for clinical trial’. When I questioned the doctor about the same he said the trial had been completed. However, I suspected foul play and went ahead and checked on Clinical Trial Registry of India’s (CTRI) website, where I found that not only was the on-going but the drug given by the doctor led to severe side effects like cramps, nausea, abdominal pain etc. I immediately wrote to the health ministry about it thinking that it would make them aware of the illegal activities taking place in the name of research. Four months later I received their letter. However it was meant for the same doctor asking for his explanation with a cc to me. But after that, that is in 2012-2013, nothing happened. There is no progress in my case.”

Taras said he was speaking out as he wanted to create awareness in society about illegal practice around clinical trials.

Amitava Guha, campaigner and crusader for victims’ rights and against illegal clinical trials said a set of demands has been placed before the government including better compensation for victims of failed trials or those who suffer from severe adverse events (SAE). “The compensation should be anywhere between Rs 1 lakh to Rs 75 lakh,” he said.

He termed the government’s proposal to slap a penalty of Rs 1 lakh on pharma company/hospital or doctor for failure of a trial; causing pain or causing death of a subject as ‘ridiculous’. The activists have sought a number of changes in the draft bill on clinical trials and rules, 2018 placed by the drug standard organisation.

“We want stringent punishment against them so that illegalities in clinical trials can be curbed,” he said.

SHARE THIS ARTICLE ON
Start 14 Days Free Trial Subscribe Now
OPEN APP