Illegal clinical tests stirs TN Govt into action
The Govt plans to make all unauthorised tests illegal after a complaint that over 400 people were misled and taken for clinical trials.india Updated: Dec 06, 2006 18:12 IST
A complaint regarding clinical trails on over 400 healthy persons in Tamil Nadu by misleading them into believing that it was a routine medical check-up has stirred the government into action.
The Lok Sabha was on Wednesday informed that the Ministry of Health and Family Welfare has ordered an inquiry into the complaint.
An anonymous complaint was received by the Central Drug Standard Control Institution, alleging that Shreon Cancer Research Institute, Yercaud Adivaram and SKS Hospital have conducted clinical trials on 400 health persons.
"They were mislead by being told that it was a medical check-up," said Panabaka Lakshmi, minister of state for health.
These clinical trials were stated to have been done under the banner of Lotus Laboratory, a branch of Sheron Cancer Centre, she said, adding that it was also alleged that some of the subjects for this clinical trial were suffering from recurring pain in the legs and loss of sexual desire.
"The Deputy Drugs Controller (I), South Zone, CDSCO, Chennai, has been directed to conduct an investigation into the complaint in association with the Drug Controller of Tamil Nadu and subject experts and submit a report to the mnistry," she said in a written reply.
She also said that the government was considering a proposal to amend the Drug and Cosmetic Act to provide protection to persons against unauthorised clinical trials.
The amendment will provide that no person shall conduct clinical trials of any drug or cosmetic drug except under, and in accordance with, the permission granted by Central Drug Authority, she said.
In case of any violation, penal action like imprisonment and fine up to Rs 20 lakh or both may be imposed, she added.