Supreme Court bans all drug trials for lack of monitoring mechanism

The Supreme Court today banned all clinical trials for new drugs in the country until a suitable monitoring mechanism for human trials of is put in place.

A bench of the apex court headed by Justice RM Lodha said that a system must be put in place to protect the lives of people and asked the central government not to allow clinical trials for untested medicines.

Accordingly, the central government has agreed to withdraw permission earlier granted for clinical trials of 162 drugs.

In its order, the Supreme Court has asked the centre to consider the suggestions of the various stakeholders before putting in place such a mechanism in order to avoid any serious and adverse impact.

The court pronounced the judgement on a public interest litigation filed by NGO Swasthya Adhikar Manch, which alleged that pharmaceutical firm are carrying out large scale clinical drug trials across the country incognito using Indian citizens as guinea pigs.

The court had, in an earlier order, directed the government to put in place a mechanism to monitor clinical trials of untested drugs on humans, which require certain mandatory standards to be followed.

It had directed the centre to convene a meeting of concerned officials of all the states to frame a law for regulation of clinical trials of drugs by multinational pharma companies. It had also ordered that all drug trials should be done under the supervision of the union health secretary.

Unregulated drug trials involving multinational drug firms were, in fact, creating ''havoc'' in the country with new challenges and new diseases posing a challenge to the healthcare system.

So far, both the centre and state governments have failed to stop the functioning of unregulated clinical trial rackets that have even caused deaths. The SC had slammed the centre for its ''deep slumber'' in addressing the ''menace'' of these drug trial rackets.

The centre, in its affidavit had also admitted that 2,644 people had died during clinical trials of 475 new drugs between 2005 and 2012.

''Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,'' the affidavit had said.

''Around 11,972 serious adverse events (excluding death) were reported during the period from 1 January 2005 to 30 June 2012, out of which 506 events were found to be related to clinical trials,'' the centre had said.

In its PIL, the NGO had alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states.