India?s Supreme Court bans clinical trials of drugs

India?s Supreme Court bans clinical trials of drugs

New Delhi (ISJ): India?s apex court on Monday (Sept 30) ordered, clinical trials for new drugs should not be held until a mechanism is put in place to monitor them and protect the lives of people on whom the drugs are tested.

Supreme Court of India made the observation while considering a public interest litigation, PIL filed by NGO Swasthya Adhikar Manch. The NGO had alleged several pharmaceutical companies are conducting indiscriminate clinical trials, using humans as guinea pigs.

The court asked the Central government to put in place a mechanism to protect the lives of people and stop clinical trials for untested medicines. It also directed the government to frame a law for regulation of clinical trials of drugs by multinational pharmaceutical companies. The court also asked the government to take suggestions from stakeholders.

The Centre, in an affidavit to the court, had assured, it will not allow clinical trials for 162 drugs permitted by it earlier. In its affidavit, the government had admitted the death of 2,644 people during clinical trials of 475 drugs between 2005 to 2012.

Describing unhindered drug trials as a menace, the court observed the government has slipped into deep slumber and had ordered all drug trails to be conducted under the supervision of Union Health Secretary. It had also directed the Centre to frame a law for regulation of clinical trials of drugs by multinational pharmaceutical companies, in consultation with state governments.

A parliamentary panel had also criticized the government for gross irregularities in drug trials and under-reporting of lapses in monitoring serious adverse events. The Parliamentary Committee on Health had recommended the Health Ministry should at least now work in close coordination with other concerned departments/organizations to undertake a comprehensive analysis of the process of granting permission to research studies having hazardous effects on health and put in place a fool-proof system for pre-empting unethical research studies.

The report, in the wake of deaths of some female children and adolescents in Khammam district of Andhra Pradesh, after being administered Human Papilloma Virus (HPV) vaccines, recommended that in future, all guidelines and norms should be adhered to before allowing trials of any drug including vaccines on Indian population. The vaccination trials were carried out by an American agency, Programme for Appropriate Technology in Health (PATH). The project was reportedly funded by American charity, Bill and Melinda Gates Foundation.

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