India - Anger over tests on Indian children

India - Anger over tests on Indian children

Article Type: News and views From: International Journal of Health Care Quality Assurance, Volume 25, Issue 4

Keywords: Clinical trials, Healthcare ethics, Medical research regulation

In India, 12 doctors have received relatively small fines for conducting secret drug tests on children and people with learning disabilities, causing an outcry among activists.

All the patients, who were unwittingly used as guinea pigs in clinical trials without their consent, had gone to government hospitals seeking routine treatment. The doctors were paid in secret by pharmaceutical companies whose drugs were aimed at treating a disparate array of disorders, including sexual dysfunction.

The incident raises concerns that India may be turning into a hot spot for human rights abuses by both pharmaceutical giants and local drug manufacturers.

The state government of Madhya Pradesh, the region of India where the tests took place, said that the doctors had refused to give more information about their patients, and had sought protection under confidentiality laws.

Doctor and whistleblower Anand Rai said that the light punishment would not deter doctors from continuing to conduct secret trials, even though non-consensual drug trials are a criminal offence. He said that Madhya Pradesh could not fine the doctors more than 5,000-rupees, only penalising the men for their failure to inform patients what was happening.

Ajay Singh, the leader of opposition in the Madhya Pradesh assembly, said that the fines were ridiculous.

The low cost of making bribes in India makes it an attractive prospect for companies with low moral standards, and in this case Rai was suspended from his job for exposing the 12 doctors.

Rai said that the regulatory system in India was corrupt, and that pharmaceutical companies found registering patients and beginning trials easy. He said that registering even a handful of patients was an expensive and lengthy process in richer nations, and that the same company could perform the same trial on 2,000 Indian patients within the same time period.

The Indian Council of Medical Research only recently sought proposals for new draft guidelines regarding drug trials that would compensate them equitably for any temporary or permanent disability resulting from a drug trial.

A doctor who wished to remain anonymous said that every clinical trial needed to be cleared by a locally-constituted ethics committee, then passed through the Central Drugs Standards Control Organisation and the Clinical Trials Registry of India.

He said that most organisations, including reputable hospitals, took advantage of great poverty in India’s tribal areas and recruited economically disadvantaged people, some of whom became ill or died during the trials.

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