The Drugs Controller General of India (DCGI) has sent notices to two major Hyderabad-based hospitals - Nizam's Institute of Medical Sciences (NIMS) and Apollo Hospitals - seeking clarifications for allegedly conducting clinical trials without proper permission from the authorities.
The DCGI notice to these prominent hospitals in the country is based on a news reports in a prominent daily which said that Arogyashree patients are being turned to guinea pigs in these hospitals and also stated that clinical trials are being conducted at these hospitals.
The DCGI asked the companies to explain on the news report which alleged that Nizam's Institute of Medical Sciences, Hyderabad and Apollo Hospitals, Hyderabad are making enormous economic gains by conducting clinical trials on poor patients. The news column also states that the most of the clinical trials are taking place in government hospitals because recruitment of patients is easy and getting a signature on the consent form is not difficult. The drugs which are being tested there are for diabetes, cancer, cardiac, gastro and liver conditions. Certain drugs for hormonal problems as well as rheumatic disorders are also being tested there. The news report further states that manpower is being hired to carry out the trials to meet its growing demand.
“In view of above you are requested to furnish the clarification in respect of the following issues: The number of clinical trials being undertaken by your organisation along with number of subjects involved and other details of such trials; Whether the requisite permission for conducting such clinical trials has been obtained from the per cent DCG(I); and whether the trials being conducted are registered at Clinical Trial Registry of India (www.ctri.nic.in)”, the DCGI letter said.
The DCGI has asked the two companies to provide details by February 18 this year.