Drug trials in India 'causing havoc to human life'

India's Supreme Court said Thursday that unregulated clinical trials of new drugs were causing "havoc" in the country as it ordered the health ministry to monitor any new applications for tests.

The comments were made during a hearing on a petition detailing deaths and health problems caused by clinical trials carried out on Indians, often without their knowledge or consent.

"Uncontrolled clinical trials are causing havoc to human life," Justice R.M. Lodha observed.

"There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far."

The judge, who has previously stated that Indians are being used like "", ordered the to monitor all new applications for trials from pharmaceutical companies.

Low costs, weak laws and inadequate enforcement and penalties have made India an attractive destination for the tests, activists say.

The petitioners in the public interest litigation case—a group of doctors and a voluntary organisation—claim several patients seeking medical help in the central state of Madhya Pradesh were used in drug tests.

The groups say they have compiled and submitted a report on more than 200 cases in which patients were subjected to trials to check the efficacy of various new treatments without their permission.

Drug trials are an essential step for pharmaceutical companies in order to win regulatory approval to bring to market.

Earlier this year, 12 doctors were accused of conducting secret trials on children and patients with learning disabilities. They paid fines of less than $100 each.

Faced with mounting criticism, the Indian Council of Medical Research in 2011 sought proposals from doctors and health activists on new for compensation for people used in drug trials.

add to favorites email to friend print save as pdf

Related Stories

India probes charges of violations by drugs regulator

May 10, 2012

India's Health Ministry said Thursday it was examining charges that the government's top drug regulatory agency had colluded with pharmaceutical firms to approve drugs without proper clinical trials.

Indian expert panel to probe drugs regulator

May 11, 2012

India's Health Ministry said Friday it had set up an expert panel to review the operations of its drug regulatory agency, accused of colluding with pharmaceutical firms to approve drugs without trials.

Recommended for you

New US restrictions on painkiller to take effect

1 hour ago

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

Boxed warnings are common in novel therapeutics

Aug 19, 2014

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

User comments