At least 22 people lost their lives last year during clinical trials for drugs and cosmetics in the country, the Rajya Sabha was informed on Tuesday.
“As per information made available by the sponsors/Clinical Research Organisations, compensation has been paid in 22 cases of trial related deaths which occurred in 2010,” Health Minister Ghulam Nabi Azad said in reply to a written question on the matter.
The Health Minister also stated that the government did not maintain any information in respect of money earned through clinical trials. “However, the Drugs Controller General (India) grants approval for conduct of Clinical trials under Drugs and Cosmetics Rules, 1945,” he said.
The minister informed the House that under the Good Clinical Practice Guidelines for clinical trials in India, trial subjects may be paid for the inconvenience and time, and should be reimbursed for expenses incurred while participating in such a research. “They may also receive free medical services,” he said.
The minister’s written statement said all payments, reimbursement and medical services to be provided to research subjects should be approved by the Ethics Committee.
As per mechanism for clinical trials of drugs, research subjects who suffer physical injury as a result of their participation in the clinical trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment. In case of death, their dependents are entitled to material compensation, Mr. Azad said.
While listing out the mechanism, the Minister said under the Drugs and Cosmetics Rules, 1945, clinical trial on a new drug shall be initiated only after the permission has been granted by the Licensing Authority under Rule 21(b) that is Drugs Controller General (India) and the approval obtained from the respective ethics committee(s).
The trial site may accept the approval granted to the protocol by the ethics committee of another trial site or the approval granted by an Independent Ethics Committee (constituted as per provisions under Schedule Y to the said Rules), provided that the approving ethics committee is willing to accept their responsibilities for the study.
“It is the responsibility of the Ethics Committee (EC) that reviews and accords its approval to a trial protocol to safeguard the rights, safety and well being of all trial subjects,” the reply stated.
