Regulatory Focus™ > News Articles > Indian Parliamentary Report Says Clinical Trials Not Being Conducted Properly

Indian Parliamentary Report Says Clinical Trials Not Being Conducted Properly

Posted 10 May 2012 | By Alexander Gaffney, RAC 

A scathing report from the Parliament of India's Standing Committee on Health and Family Welfare (SCHFW) indicates pharmaceutical companies in the country are increasingly moving their clinical trials to smaller cities, potentially risking future patients' safety by enrolling less-representative sample populations, reports The Economic Times.

The Times notes pharmaceutical companies have traditionally conducted their clinical trials in larger population centers, which allowed them to attract a more diverse population in their clinical trials.

However, this trend seems to have shifted, and the SCHFW blasted the shift as an attempt to subvert clinical trial regulations in the country.

"According the committee, the purpose of phase III trials is to determine ethnic/racial differences in the safety, efficacy and metabolism of drugs," explained The Times.

"Hence to serve any useful purpose, patients of different ethnicities living in India should be enrolled" noted SCHFW's report. Otherwise, the "submission is incorrect and the basic purpose of phase-III trials, even when conducted, is not being served."

The report cites a number of clinical trials conducted in non-cosmopolitan centers, and said the homogeneity of the populations in smaller population centers has the potential to skew study results by reducing genetic variation.

The Times notes the SCHFW "recommended that while approving Phase-III clinical trials, [India's regulatory authority] should ensure that the trials are spread across India so as to cover patients from major ethnic backgrounds and ensure a truly representative sample."

Read more:

The Economic Times - Pharmaceutical companies targeting smaller cities for drug trials

Regulatory Focus - Scathing Parliamentary Report Blasts India's Drug Regulatory Authority

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