No Clinical Trials Should be Allowed for New Drugs without a Proper System: SC

The Supreme Court of India on 30 September 2013 pronounced that no clinical trials should be allowed for new drugs till a mechanism is put in place to monitor them and to protect the lives of people on which drugs are tested.

While pronouncing the judgment, the bench headed by Justice R M Lodha told that a system must be put in place to protect the lives of people and asked the Centre not to allow clinical trials for untested medicines.

The bench also directed the Centre to consider suggestions of various stakeholders in putting in place the mechanism to avoid any serious and adverse impact.

Government officials assured the Supreme Court that Center will not allow clinical trials for 162 drugs permitted by it earlier.

The Supreme Court of India also earlier directed on the issue of clinical trials. It directed the Government to follow a certain mandatory standards for clinical trials of untested drugs on humans being.

In an affidavit the Centre admitted that 2644 people died during clinical trials of 475 new drugs between 2005 -12.It also presented that during 2005 to 2012 serious adverse events of deaths during clinical trials of 2644 were 80 deaths.

The judgment given by the Supreme Court of India in the background of hearing a Public Interest Litigation (PIL) filed by NGO Swasthya Adhikar Manch ,alleging large scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests.

The NGO also told the Supreme Court of India that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states.