Questions crop up over compliance of norms by Niloufer Hospital

Hyderabad: Questions are being raised over the compliance of regulations by the doctors of Niloufer hospital which is most sought after for treating women and children.

According to sources in the State Medical Education Department (SMED), there is no clarity as to whether the doctors at the Niloufer hospital are carrying out Investigator-Initiated Studies (ISSs) or trials falling within the ambit of the Regulatory or Clinical Trails (R&CT).

Speaking to The Hans India, a senior doctor from the SMED said, "there are two kinds of studies, one is a regulatory or clinical trial, and the second one is ISSs.

Earlier, in both the cases, permissions had to be sought from the Drug Controller General of India (DCGI). Besides, the hospitals have to comply with other regulations like Ethical Guidelines of the Indian Council of Medical Research (2006), Ethical Guidelines for Biomedical Research on Human Participants', in particular when involving research in children or herbal research etc."

However, unlike earlier, due to the change in the rules, the IISs with new drugs are needed only approvals from the Ethics Committee (EC) or Institutional Ethics Committee (IEC) formed within the institution, hospital or medical colleges.

This change was brought in to allow academic research to flourish. The ISSs studies are not intended for generating data to make any kind of regulatory submission.

But, it is mandatory on the part of the Niloufer administration and the investigators to ensure that the EC or IEC formed within the institution are registered with the central licensing authority and the registration renewed at the end of 3 years.

This is mandatory for RCT. In the case of the RCT, registration is must with the Clinical Trials Registry-India (CTRI). Further, the registration must be done before the first participant is enrolled.

"As of now the CTRI current status on the Niloufer hospital shows that it is not conducting any clinical trials and no registration is being done with it," the sources added.

That apart, obtaining informed consent from participants in written form, particularly if it was a serious issue of trails involving vulnerable participants like children, mentally challenged patients.

Also, trials involved a new chemical entity or a new molecular entity the investigators also have to ensure audio-visual recording of the informed consent process.

The SMED sources said whether Niloufer is conducting ISSs for the RCT needs to be verified and this will be known only after receiving a report from the hospital, the official said.

Also, the Niloufer hospital is reportedly violating the existing rules by not disclosing the details of EC or IEC formed within the institution on its website.