Drugs controller told to file affidavit on clinical trials

May 24, 2014 11:12 am | Updated 11:12 am IST - KOCHI

A Division Bench of the Kerala High Court on Friday directed the Drugs Controller General of India and the Central Drugs Standard Control Organization to file an affidavit in response to a writ petition seeking a directive not to allow clinical trials on patients in the State without obtaining their genuine informed consent.

The Bench comprising Chief Justice Manjula Chellur and Justice P.V.Asha granted the drug controller and the organisation four weeks time to file the affidavits.

The order came on a petition filed by a Thrissur-based NGO, Jananeethi. According to the organisation, clinical trial on patients were being conducted without obtaining their informed consent. No ethical committee on each trial was constituted before conducting the trial as per the ethical guidelines. In fact, there were malpractices in obtaining the prior consent from the patients who were selected for undergoing the drug trials.

Even details such as the drugs, risk involved and also the side-effects of the drugs tested on the patients were not disclosed to them.

Revamp of Devaswom

The State government informed a Division Bench that a committee headed by retired High Court Judge M. N. Krishnan would soon be constituted to study the revamping of the Guruvayur Devaswom administration.

In a report submitted to the court, the government said an IAS officer would be appointed as the administrator of the temple. The report was submitted in a case relating to the assault on a devotee by a security guard inside the temple.

The government informed the court that the security guard concerned had been suspended from the service.

Compensation

A Bench comprising Justice Thottathil B. Radhakrishnan and Justice A. Muhamed Mustaque ordered the Kerala State Electricity Board (KSEB) to pay a compensation of Rs.4,62,000 to the legal heirs of a person who was electrocuted while removing an arch erected across Adimaly-Chinnar Road at Kambilikandam in Idukki district.

The arch was erected welcoming the Minister for Electricity who had inaugurated a substation at Kambilikandam. Prasanth was electrocuted in 2006 when he came into contact with an 11-kV overhead electric line that passed across the road while removing the arch.

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