New Delhi, August 12th, 2011
The National Human Rights Commission, NHRC, has taken suo motu cognizance of a media report alleging that 1,725 persons have lost their lives to drug trials in the last four years in the country which indicate complete ineffectiveness of regulatory controls over the $400 million sector.

It is alleged in the report that many of the drugs being tested are not even of specific relevance to the country and could have been tested anywhere. Equally shocking is the fact that the rules, under the Drugs and Cosmetics Act, entirely trust the trial investigator with the reason attributed for the death of a subject. This is resulting in gross under reporting of actual deaths during clinical trials.

Allegedly, there has been evidence of weak monitoring of requests of the companies approaching the Drug Controller with a protocol to get approval for drug trials as per rules. Reportedly at present 1,868 clinical trials are going on as per the official records of the Drug Controller General of India.

The Commission has observed under the case no. 787/6/0/2011 that if the contents of media report are true then these raise a serious issue of violations of human rights of the drug trial victims, who are put to drug trials in India either without their consent or with the consent but without understanding its complications.

Notices have been issued to the Secretary (Health), Government of India, Secretary, Indian Council of Medical Research (ICMR) and the Drug Controller General of India to submit their comments in the matter within four weeks.

They are also directed to inform the Commission :

" What are the guidelines and regulations in place for conducting drug trials and for setting up Ethics Committees in hospitals to ensure patients safety?
" What are the guidelines to be followed by Ethics Committees for approving drug trials after a proposal is cleared by the Drug Controller General of India?
" What are the safeguards for ensuring that the Ethics Committees function properly?
" Whether the infrastructure in the office of the Drug Controller General of India is sufficient to cope-up with the applications for approval of drug trials in India?
" What studies have been undertaken by the authorities to find out the reasons and lapses, if any, in case of deaths of persons in various States of India during drug trials?
" Whether there is any uniform policy for compensating the victims or the next of kin of the deceased, who die during drug trials - whether authorised or unauthorised.
" What is the policy of the Government of India with regard to the nature of drugs being tested in the country keeping in view the fact that many of the drugs may be tested elsewhere?

A notice has also been sent to the Centre for Studies in Ethics and Rights, Anusandhan Trust, Mumbai seeking its comments within four weeks on the subject.

The Commission has also decided to take up the case of six women, who allegedly became victims of an unauthorised drug trials in Andhra Pradesh and the reports received from the concerned authorities their report along with this case before the Full Commission.


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