New Delhi, March 19th, 2012

The National Human Rights Commission taking a serious view of non-submission of reports into unauthorized clinical drug trials by the Secretary, Union Ministry of Health, the Secretary, Indian Council of Medical Research, the Drug Controller General of India and the Chief Secretary, Andhra Pradesh has asked them to submit these within six weeks positively failing which the Commission may invoke the provisions contained in Section 13 of the Protection of Human Rights Act, 1993.

The Commission on the basis of a complaint and media reports in the context of unauthorized drug trials on six women from Andhra Pradesh in June last year had issued notices on 20.06.2011 to concerned authorities in the State and the Centre and had also directed its investigation team to ascertain the facts.

Allegedly, 25 poor women in Guntur were lured in for testing a cancer drug by a Hyderabad based pharmaceutical company. After taking the drug six women had to be hospitalized for complications.

The media reports had also alleged that there was no effective law to monitor clinical trials in India. This was one of reasons that the country has emerged as a hotspot for foreign companies, which unhesitatingly flout all rules and regulations to test their products on Indians.

Subsequently, the concerned State and Central authorities were again asked to send reports on 26.09.2011 and 05.12.2011. The only communication received from the Drug Controller General of India dated 07.07.2011 stated that all the drug trials were required to be conducted as per Good Clinical Practices guidelines issued by the CDSCO. However, there was no specific response to the issues raised by the Commission in its notices to him. Neither a copy of GCT guidelines was submitted.

The investigation team of the Commission found that there were eight more laboratories in Hyderabad in addition to Axes Clinicals Ltd. which were conducting clinical drug trials. After ascertaining the facts, it had made the following recommendations:-

i) Health Secretary, Andhra Pradesh to properly assess the health conditions of the villagers of unauthorized drug trials and suitable compensation paid to the victims by the Axis Clinicals Ltd.
ii) Central Drugs Standard Control Organization, CDSCO to conduct proper study in various parts of India to ensure lapse adhere to the guidelines on clinical drug trials.
iii) The amount paid to the volunteers for drug trials needed to be adequately increased and it should be monitored by CDSCO.

Apart from this, the Commission also made following queries from the Secretary, Indian Council of Medical Research and the Drug Controller General of India:-

" 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 inform policy for compensating the victims or the next of kin of the deceased, who die during drug trials - whether authorized or unauthorized.

" 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?


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