India -Supreme Court warns it can ban clinical trials


Published: Tuesday, Oct 9, 2012, 8:24 IST
By Rakesh Bhatnagar | Place: New Delhi | Agency: DNA

 

Distressed at the rampant misuse of the practice of clinical trials by negligent doctors and drug companies that have killed 1,954 patients since 2009 in the country, the Supreme Court has asked the Centre and various states governments to reveal the truth behind such gruesome tragedies.

Expressing anguish at the sordid affairs in the private and government hospitals including mental hospitals, a bench of justice RM Lodha and justice AR Dave on Monday also asked Union government to inform about the side effects of these trials and whether the close relatives of victims had been adequately compensated.

During the inconclusive hearing in a PIL filed by an NGO Swasthya Adhikar Manch alleging large scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs, the court said “we are very serious about this matter’’.

“We can even issue a one-line direction that all these clinical trials which affect many people must stop forthwith. It must suffice, we are very serious about it,” judges told additional solicitor general Siddharth Luthra.

Responding to an earlier direction, the Madhya Pradesh government sought to put the record straight and said charge sheets have been filed against several private and government doctors who had been performing these tests illegally.

It has admitted that both private clinics and government hospitals had been indulging in the tests illegally.

However, it also drew the court’s attention towards Union health minister Ghulam Nabi Azad’s statement in parliament confirming deaths of 1,954 persons from 2009 till June 2012 due to “serious adverse events of death” in clinical trials. Azad also told the House that these deaths could be attributed to various reasons and the side effects of the drugs not ruled out.
Seeking blanket ban on clinical trials that were engineered by various pharmaceutical firms from India and abroad, petitioner’s counsel Sanjay Parikh contended that permission for trials were granted by the Central government without consulting the states.
However, MP’s lawyer Dushyant Dave said the states cannot be faulted for the tests.

But the judges pointed out that the clinical trials were conducted in state governments hospitals whose employees and doctors are under the control of the respective state governments.

Judges said there are reports about deaths due to clinical trials saying “one person is dying every day. Human beings are treated as guinea pigs. We do not know personally but we believe a responsible statement is made before the court’’.

In the public interest litigation, Parikh had said over 3,300 patients were used for the tests in Madhya Pradesh.

 

2 Comments (+add yours?)

  1. Trackback: #India- Clinical trials: Regulating chaos #Medical ethics #Humanrights « kracktivist
  2. Trackback: The dark underbelly of India’s clinical trials business- #medical ethics #humanrights « kracktivist

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