With reports of illegal trials affecting public safety, the Central drug authorities have asked all the State drug controllers to keep a close tab on the clinical trials happening around and stop illegal trials especially those done individually by the doctors without due permission from the Central Drugs Standard Control Organisation (CDSCO).
Talking to Pharmabiz, Drug Controller General of India (DCGI) Dr G N Singh admitted that there could be individual cases of doctors carrying out trials on their own for some companies, Indian or foreign, without informing the authorities. Such cases lead to unethical practices and cause troubles, he added.
“It is not easy to monitor or track such individual cases as they do not come through the official mechanism. We cannot ensure that norms are followed by them as they do not seek licenses or get the trials registered. Unless the public awareness is raised and the cases are reported to the authorities by the public, it is difficult to track such cases,” he said.
“We have asked the State Drug controllers to closely monitor all trials and find out such illegal cases. We are also planning to launch steps to raise awareness among the people so that such illegal trials can be stopped,” Dr Singh said.
The DCGI also said the Government had taken a number of steps to strengthen the regulation and monitoring of trials in the country. Twelve new drug advisory committees and six medical device advisory committees have been constituted to evaluate clinical trial proposals. These committees comprise experts from central and state government medical institutions.
There had been several instances of malpractices during clinical trials in the recent past, especially by independent practitioners who carry out trials on their patients without getting the consent or even without informing the subjects. It is also alleged that these doctors are paid by foreign companies to conduct such trials.
In the controversial case involving the mental patients at the Mahatma Gandhi Medical College and Mental Hospital, Indore also, it was found that a couple of doctors held trials on the patients at their private clinics without taking consent from the subjects.