Clinical trials: Drugs Control Department clueless

Published: 05th January 2013 10:22 AM  |   Last Updated: 05th January 2013 10:22 AM   |  A+A-

Even as stories of illegal human clinical trials conducted by hospitals and drug companies hog the limelight, the officials of the State Drugs Control Department are clueless about the ways to effectively monitor such activities in the state.

Not only do the officials have any experience in dealing with the issue at hand, but also have no information on the number of hospitals that have received sanction to conduct the trials.

According to the data with the Clinical Trials Registry of India (CTRI), as many as 200 tests that involve human trials, have been sanctioned in various hospitals in the state since 2009. Tests have been conducted at various hospitals, including those with hi-tech facilities to the research centres to the low-cost hospitals.

As of now, the functioning of the clinical trials are monitored and reported solely by   ethics committees comprising ‘independent’  scientists, legal experts, clinicians and other medical and non-medical experts, who do not come under any government body. 

A recent government order issued by the Office of the Drugs Controller General of India to all the offices of the Central Drugs Standard Control Organisation (CDSCO) and the Drug Control Authorities of the state specifically states that ‘any clinical activity in contravention of Schedule Y of the Drugs and Cosmetics Act or the Good Clinical Practices guidelines or other applicable regulations will be viewed as non-compliance to statutory requirements and action will be taken under the Drugs and Cosmetics Act.’ But, though the order is in place, the ground-level reality is different.

 “Though we have been served a directive, we do not have any mechanism to implement it. We have no information about the number of hospitals in the state where the trials are being conducted or the ethics committees that are involved. We have not been intimated either by the Office of the Drugs Controller General of India or the hospitals concerned when such clinical trials happen. Unless a complaint is lodged, there is no way that we can take action or even monitor the trials,”  said an official with the State Drugs Control Department.


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